
[Federal Register: August 13, 2008 (Volume 73, Number 157)]
[Rules and Regulations]               
[Page 47065-47072]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au08-12]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0097; FRL-8376-2]

 
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 apple, wet pomace; asparagus; bean, succulent; 
bean, dry seed; beet, garden, tops; beet, garden, roots; brassica, 
leafy greens, subgroup 5B; coffee, green bean; coffee, roasted bean; 
corn, field, grain; corn, field, forage; corn, field, stover; corn, 
pop, grain; corn, pop, stover; corn, sweet, kernel plus cob with husks 
removed; corn, sweet, forage; corn, sweet, stover; cotton, undelinted 
seed; cotton, gin byproducts; Fruit, pome, group 11; fruit, stone, 
group 12, except cherry; grain, aspirated fractions; hop, dried cones; 
lychee; mango, postharvest; okra; onion, bulb, subgroup 3-07A; onion, 
green, subgroup 3-07B; plum, pre- and post-harvest; turnip, roots; 
turnip, tops; soybean, forage; soybean, hay; soybean, seed; sunflower, 
seed; sunflower, meal; sunflower, refined oil; and vegetable, cucurbit, 
group 9. Bayer CropScience LP and Interregional Research Project No. 4 
(IR4) have requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

[[Page 47066]]


DATES: This regulation is effective August 13, 2008. Objections and 
requests for hearings must be received on or before October 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 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 October 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 28527) (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 pesticide petitions (PP) 6F4668, 
0F6086, 0E6091, 0F6129, 1F6289, 4E6842, and 4F6854 by Bayer CropScience 
LP, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 
27709. The petitions 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: Fruit, pome, group 11 at 
0.05 parts per million (ppm) (PP 6F4668); bean, succulent at 0.1 ppm 
(PP 0F6086); bean, dry seed at 0.1 ppm (PP 0F6086); cotton, undelinted 
seed at 2.0 ppm (PP 0F6086); cotton, gin byproducts at 16 ppm (PP 
0F6086); asparagus at 0.01 ppm (PP 0E6091); coffee, green bean, at 0.1 
ppm (PP 0E6091); coffee, roasted bean, at 0.2 ppm (PP 0E6091); garlic, 
dry bulb at 0.1 ppm (PP 0E6091); onion, dry bulb at 0.1 ppm (PP 
0E6091); corn, field, grain at 0.01 ppm (PP 0F6129); corn, field, 
forage at 3.0 ppm (PP 0F6129); corn, field, stover at 3.0 ppm (PP 
0F6129); corn, pop, grain at 0.01 ppm (PP 0F6129); corn, pop, stover at 
3.0 ppm (PP 0F6129) corn, sweet, kernel plus cob with husks removed at 
0.5 ppm (PP 0F6129); corn, sweet, forage at 6.0 ppm (PP 0F6129); corn, 
sweet, stover at 5.0 ppm (PP 0F6129); soybean, seed at 0.01 ppm (PP 
0F6129); soybean, forage at 0.01 ppm (PP 0F6129); soybean, hay at 0.05 
ppm (PP 0F6129); fruit, stone, group 12, except cherry at 1.0 ppm (PP 
1F6289); hop, dried cones at 30.0 ppm (PP 4E6842); soybean, seed at 
0.06 ppm (PP 4F6854); soybean, forage at 17 ppm (PP 4F6854); soybean, 
hay at 45 ppm (PP 4F6854); soybean, hulls at 0.06 ppm (PP 4F6854); and 
grain, aspirated

[[Page 47067]]

fractions at 15 ppm (PP 4F6854). Bayer CropScience also proposed to add 
a postharvest use on cherries at the current 0-day pre-harvest 
tolerance level of 4.0 ppm. That notice referenced a summary of the 
petitions 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. Note that the tolerances proposed 
for the food commodities listed under PP 0E6091 were import tolerances.
    Additionally, in the same Notice of filing, EPA announced the 
filing of PPs 9E6045, 9E6046, 9E6048, 0E6103, 0E6117, 0E6153, 0E6158, 
and 0E6212 from Interregional Research Project No. 4 (IR4), 681 U.S. 
Highway 1 South, North Brunswick, NJ 08902-3390. The petitions 
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: Turnip, tops at 8.0 ppm (PP 
9E6045); turnip, roots at 0.4 ppm (PP 9E6045); hops at 5.0 ppm 
(9E6046); vegetable, cucurbit, group 9 at 0.1 ppm (PP 9E6048); mango, 
postharvest at 0.2 ppm (PP 0E6103); fruit, stone, group 12, except 
cherry at 1.0 ppm (PP 0E6117); sunflower, seed at 0.05 ppm (PP 0E6153); 
sunflower, refined oil at 0.2 ppm (PP 0E6153); sunflower, meal at 0.2 
ppm (PP 0E6153); okra at 1.0 ppm (PP 0E6158); and lychee at 1.5 ppm (PP 
0E6212). That notice referenced a summary of the petitions prepared by 
the IR-4, 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.
    In the Federal Register of April 12, 2006 (71 FR 18746) (FRL-7773-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of PPs 6E7036 by Interregional 
Research Project No. 4 (IR4), 681 U.S. Highway 1 South, North 
Brunswick, NJ 08902-3390. 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 the food commodity 
asparagus at 0.05 ppm. That notice referenced a summary of the petition 
prepared by IR-4, which is available to the public in the docket, 
http://www.regulations.gov. No comments were received in response to 
this Notice of Filing.
    In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of PP 6E7097 by Interregional 
Research Project No. 4 (IR4), 681 U.S. Highway 1 South, North 
Brunswick, NJ 08902-3390. 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 
vegetable, bulb, group 3 at 1.3 ppm; Brassica, leafy greens, subgroup 
5B at 2.5 ppm; beet, garden, roots at 0.7 ppm; and beet, garden, leaves 
at 5.0 ppm. That notice referenced a summary of the petition prepared 
by IR-4, which is available to the public in the docket, http://
www.regulations.gov. No comments were received in response to this 
Notice of Filing.
    Based upon review of the data supporting the petitions, EPA has 
modified the level and/or the tolerance expression for all commodities 
except the following: Pome fruit; bean succulent, cotton, undelinted 
seed; corn, sweet kernel plus cob with husks removed; sunflower, seed; 
sunflower, meal; sunflower, oil; brassica, leafy greens subgroup 5B; 
and beet, garden root. 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.

A. Toxicological Profile

    The toxicological profile for tebuconazole can be found in the 
final rule published in the Federal Register of May 14, 2008 (73 FR 
27748-27756, FRL-8364-6). Refer to this Federal Register document, 
available at http://www.regulations.gov for a detailed discussion of 
the toxicological profile of tebuconazole.

B. Toxicological Endpoints

    The toxicological endpoints for tebuconazole can be found in the 
final rule published in the Federal Register of May 14, 2008 (73 FR 
27748-27756, FRL-8364-6). Refer to this Federal Register document, 
available at http://www.regulations.gov, for a detailed discussion of 
the toxicological endpoint selection for tebuconazole.

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. Projected percent crop treated estimates were used for apples, 
apricots, cherries, hops, plums and sweet corn. For the remaining 
crops, 100% crop treated was assumed. Available

[[Page 47068]]

processing data were used to refine anticipated residues for apples/
pears (dried and juice), apricots (dried), cherry (juice), coffee 
(roasted bean), grapes (juice), plums (prunes/prune juice) and peanut 
(oil). For all other processed commodities, DEEM (ver. 7.81) default 
processing factors were assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the same assumptions as stated above for acute 
exposure (Unit III.C.1.i).
    iii. Cancer. As explained in the Federal Register of May 14, 2008 
(73 FR 27748-27756, FRL-8364-6), 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 percent crop treated (PCT) 
information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use 
available data and information on the anticipated residue levels of 
pesticide residues in food and the actual levels of pesticide residues 
that have been measured in food. If EPA relies on such information, EPA 
must require pursuant to FFDCA section 408(f)(1) that data be provided 
5 years after the tolerance is established, modified, or left in 
effect, demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    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 assumed PCT for grapes; grape, raisins; nectarines; 
oats; peaches; 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 1. 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 apple (44% acute assessment, 41% chronic 
assessment); apricot (56% acute assessment, 43% chronic assessment); 
cherry (pre-harvest: 42% acute assessment, 37% chronic assessment); 
cherry (post-harvest: 100% acute assessment, 66% chronic assessment); 
corn, sweet (22% acute assessment, 14% chronic assessment); hop (64% 
acute assessment, 64% chronic assessment); plum, pre- and post-harvest 
(26% acute assessment, 24% chronic assessment); and turnip tops (68% 
acute assessment, 44% chronic assessment).
    EPA estimates PPCT for a new pesticide use by assuming that its 
actual PCT during the initial 5 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, 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 5 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 the seven crops, 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

[[Page 47069]]

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 post application 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 post application 
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. Triazole-derived pesticides can form the common metabolite 
1,2,4-triazole and two triazole conjugates (triazole alanine and 
triazole acetic acid). Refer to EPA's recent tolerance rulemaking on 
tebuconazole in the Federal Register of May 14, 2008 (73 FR 27748-
27756, FRL-8364-6), for more information on this risk assessment.

D. Safety Factor for Infants and Children

    In the Federal Register of May 14, 2008 (73 FR 27748-27756, FRL-
8364-6) the Agency published a Final rule establishing tolerances for 
residues of tebuconazole in or on various food commodities. When the 
Agency conducted the risk assessments in support of that tolerance 
action, it also assessed dietary exposure to tebuconazole assuming that 
all of the tolerances in this action were in place. Accordingly, EPA 
relies on the decision on the FQPA safety factor for infants and 
children as set out in that action. Refer to EPA's recent tolerance 
rulemaking on tebuconazole, available at http://www.regulations.gov, 
for a detailed discussion and selection of a safety factor for infants 
and children for tebuconazole. For the reasons explained there, EPA 
reduced the FQPA safety factor to 3X for all potential exposure 
scenarios.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the acute population 
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The 
aPAD and cPAD represent the highest safe exposures, taking into account 
all appropriate safety factors (SFs). EPA calculates the aPAD and cPAD 
by dividing the point of departure (POD) by all applicable uncertainty 
factors (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.
    Below, EPA has summarized the conclusions from its recent tolerance 
rulemaking on tebuconazole which took into account exposure to 
tebuconazole from the food commodities covered by the tolerances in 
this action. Refer to EPA's recent tolerance rulemaking on 
tebuconazole, available at http://www.regulations.gov, for a detailed 
discussion of EPA's safety determinations.
    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 unrealistic assumptions and EPA has concluded that aggregate

[[Page 47070]]

exposure does not pose a risk of concern.
    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. Although tebuconazole 
is classified as a Group C Carcinogen-Possible Human Carcinogen, the 
Agency has concluded that the chronic RfD is protective of the cancer 
effects.
    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 gas chromatography/nitrogen phosphorus detection and 
liquid chromatography/mass spectrometry/mass spectrometry (GC/NPD and 
LC/MS/MS) methods are available for 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 or 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 United States and Canada, 
and tebuconazole, per se, for Codex. Where possible, the proposed 
tolerance levels have been harmonized with the MRLs from Canada, 
Mexico, and Codex. With regard to the pome fruit tolerance, the Agency 
recommended tolerance of 0.05 ppm differs from the Codex MRL of 0.5 mg/
kg. Harmonization of the pome fruit tolerances is not possible because 
U.S. data were derived using long pre-harvest intervals (PHIs) of 75-
129 days while Italian data were derived using maximum PHIs of 14 days. 
With regard to the cucurbit vegetable tolerance, the Agency recommended 
tolerance of 0.09 ppm for vegetable, cucurbit, group 9, differs from 
the Codex MRL of 0.2 mg/kg on cucumber and 0.02 mg/kg on summer squash. 
The Agency notes that some of the cucumber data from Spain were derived 
from trials conducted in greenhouses. Although the application rate 
used for the Spanish trials was similar to the trials conducted in the 
United States, it is quite normal for greenhouse trials to give higher 
residues. If the greenhouse trials are ignored, then the remaining 
Codex data are in the 0.02 - 0.04 range, consistent with the U.S. data 
and tolerance. In short, the higher Codex MRL for cucumber accommodates 
the greenhouse use.

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 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, as to the commenter's concern with field trials that 
were conducted in countries other than the United States, EPA notes 
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. EPA received several 
applications for tebuconazole import tolerances and it is appropriate 
that the field trials would be conducted in the countries where the 
pesticide was to be used. Additionally, some tebuconazole import 
tolerances were proposed with foreign data, and then a U.S. use was 
proposed and U.S. data submitted. None of the other comments address 
the findings made in this action regarding the establishment of a 
tolerance. Nonetheless, EPA provides the following information 
regarding the comments. IR-4 was established by the USDA to help minor 
acreage; specialty crop producers obtain EPA tolerances and new 
registered uses of pesticides. As to whether warnings were given to 
residents of New Jersey regarding field trials, EPA would point out 
that experimental field trials are subject to EPA regulations 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 petitions, EPA 
determined that the proposed tolerances should be revised as follows: 
Cotton, gin byproducts at 25.0 ppm; asparagus at 0.05 ppm; coffee, 
green bean at 0.15 ppm; coffee, roasted bean, at 0.3 ppm; onion, bulb, 
subgroup 3-07A at 0.2 ppm; corn, field, grain at 0.05 ppm; corn, field, 
forage at 4.0 ppm; corn, field, stover at 3.5 ppm; corn, pop, grain at 
0.05 ppm; corn, pop, stover at 3.5 ppm; corn, sweet, forage at 7.0 ppm; 
corn, sweet, stover at 6.0 ppm; turnip, tops (limited to east of the 
Rockies) at 7.0 ppm; turnip, roots at 0.5 ppm; beet, garden, tops at 
7.0 ppm; beet, garden, root at 0.70; hop, dried cones at 35.0 ppm; 
vegetable, cucurbit, group 9 at 0.09 ppm; mango, postharvest at 0.15 
ppm; plum, pre- and post-harvest at 1.0 ppm; okra at 1.2 ppm; lychee at 
1.6 ppm; soybean, seed at 0.08 ppm; soybean, forage at 25 ppm; soybean, 
hay at 50 ppm; and grain, aspirated fractions 16.0 ppm. A separate 
tolerance is required for apple, wet pomace at 0.1 ppm. No tolerance is 
required for soybean hulls. A tolerance of 1.3 ppm is required for 
onion, green, subgroup 3-07B. The tolerance proposed by IR-4 for hops 
(PP 9E6046) is covered by the registrant proposed tolerance for hops, 
dried cones (PP 4E6842). EPA revised

[[Page 47071]]

most of 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). For the proposed 
tolerances on asparagus; corn, field, grain; and by translation corn, 
pop grain the tolerance could not be set lower than the limit of 
quantitation (LOQ) of the enforcement analytical method, which was 0.05 
ppm for tebuconazole. For corn, field, forage, the proposed tolerance 
was raised to 4.0 ppm based on the maximum residue level in the field 
trials.
    Additionally, IR-4 petitioned for a tolerance on bulb vegetables 
group 3 as that crop group was defined at the time of the petition 
(6E7097). In the Federal Register of December 7, 2007 (72 FR 69150-
69158) (FRL-8340-6), EPA issued a final rule that revised the crop 
grouping regulations. EPA indicated in the December 7, 2007 final rule 
as well as the earlier May 23, 2007 proposed rule (72 FR 28920-28930) 
that, for existing petitions for which a Notice of Filing had been 
published, the Agency would attempt to conform these petitions to the 
rule. As part of this action, EPA expanded and revised bulb vegetables 
group 3. Changes to crop group 3 (bulb vegetables) included adding new 
commodities, creating subgroups for bulb and green onions, and changing 
the name of one of the representative commodities from ``onion, dry 
bulb'' to ``onion, bulb''. The Bayer proposed tolerance for garlic 
(bulb) and onion (bulb) with no U. S. registration was superseded by 
the proposed tolerance for bulb vegetables. The proposed tolerance on 
bulb vegetables group 3 was determined to be inappropriate because the 
residues were found to be more than a factor of 5x. Thus, separate 
tolerances were set for the crop subgroups, onion, bulb, subgroup 3-07A 
at 0.2 ppm, and onion, green, subgroup 3-07B at 1.3 ppm.
    EPA concludes it is reasonable to revise the petitioned-for 
tolerance so that they agree with the recent crop grouping revisions 
because (1) although the new crop groups/subgroups include several new 
commodities, the added commodities are closely related minor crops 
which contribute little to overall dietary or aggregate exposure and 
risk; and tebuconazole exposure from these added commodities was 
considered when EPA conducted the dietary and aggregate risk 
assessments supporting this action; and (2) the representative 
commodities for the revised crop groups/subgroups have not changed.
    Finally, the proposed tolerance for hops, domestically grown, in PP 
4E6046, was superseded by the proposed tolerance for hops, dry cone 
(based on data for imported hops) in PP 4E6842, since the latter 
proposed tolerance is higher, 30.0 ppm. The proposed tolerance for 
asparagus (domestic) at 0.2 ppm, in PP 6E7036, superseded the proposed 
tolerance for imported asparagus at 0.1 ppm, in PP 0E6091. The 
tolerances for inadvertent residues of tebuconazole in soybeans planted 
in rotation with treated wheat in PP 0F6129, were superseded by the 
proposed tolerance for soybean following a direct treatment of 
tebuconazole in PP 4F6854.

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 
apple, wet pomace at 0.1 ppm; asparagus at 0.05 ppm; bean, succulent at 
0.1 ppm; bean, dry seed at 0.1 ppm; beet, garden, tops at 7.0 ppm; 
beet, garden, roots at 0.70 ppm; brassica, leafy greens, subgroup 5B at 
2.5 ppm; coffee, green bean at 0.15 ppm; coffee, roasted bean at 0.3 
ppm; corn, field, grain at 0.05 ppm; corn, field, forage at 4.0 ppm; 
corn, field, stover at 3.5 ppm; corn, pop, grain at 0.05 ppm; corn, 
pop, stover at 3.5 ppm; corn, sweet, kernel plus cob with husks removed 
at 0.5 ppm; corn, sweet, forage at 7.0 ppm; corn, sweet, stover at 6.0 
ppm; cotton, undelinted seed at 2.0 ppm; cotton, gin byproducts at 25.0 
ppm; Fruit, pome, group 11 at 0.05 ppm; fruit, stone, group 12, except 
cherry at 1.0 ppm; grain, aspirated fractions at 16.0 ppm; hop, dried 
cones at 35.0 ppm; lychee at 1.6 ppm; mango, postharvest at 0.15 ppm; 
okra at 1.2 ppm; onion, bulb, subgroup 3-07A at 0.2 ppm; onion, green, 
subgroup 3-07B at 1.3 ppm; plum, pre- and post-harvest at 1.0 ppm; 
soybean, forage at 25 ppm; soybean, hay at 50 ppm; soybean, seed at 
0.08 ppm; sunflower, seed at 0.05 ppm; sunflower, meal at 0.2 ppm; 
sunflower, refined oil at 0.2 ppm; vegetable, cucurbit, group 9 at 0.09 
ppm; turnip, roots at 0.5 ppm; and turnip, tops at 7.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petitions 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).

[[Page 47072]]

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: July 29, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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


0
2. Section 180. 474 is amended by revising the introductory text of 
paragraph (a)(1), by alphabetically adding the following commodities to 
the table in paragraph (a)(1); by removing the text from paragraph (b) 
and reserving the paragraph designation and heading; and by adding a 
new paragraph (c).


Sec.  180.474  Tebuconazole; tolerances for residues.

    (a) General. (1) Tolerances are established for the residues of the 
fungicide, tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol in or on the following 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Apple, wet pomace............................................        0.1
Asparagus....................................................       0.05
                                * * * * *
Bean, succulent..............................................        0.1
Bean, dry seed...............................................        0.1
Beet, garden, roots..........................................       0.70
Beet, garden, tops...........................................        7.0
Brassica, leafy greens, subgroup 5B..........................        2.5
Coffee, green bean\1\........................................       0.15
Coffee, roasted bean\1\......................................        0.3
Corn, field, grain...........................................       0.05
Corn, field, forage..........................................        4.0
Corn, field, stover..........................................        3.5
Corn, pop, grain.............................................       0.05
Corn, pop, stover............................................        3.5
Corn, sweet, kernel plus cob with husks removed..............        0.5
Corn, sweet, forage..........................................        7.0
Corn, sweet, stover..........................................        6.0
Cotton, undelinted seed......................................        2.0
Cotton, gin byproducts.......................................       25.0
Fruit, pome, group 11........................................       0.05
Fruit, stone, group 12, except cherry........................        1.0
Grain, aspirated fractions...................................       16.0
                                * * * * *
Hop, dried cones.............................................       35.0
Lychee.......................................................        1.6
Mango, postharvest...........................................       0.15
                                * * * * *
Okra.........................................................        1.2
Onion, bulb, subgroup 3-07A..................................        0.2
Onion, green, subgroup 3-07B.................................        1.3
                                * * * * *
Plum, pre- and post-harvest..................................        1.0
                                * * * * *
Soybean, forage..............................................         25
Soybean, hay.................................................         50
Soybean, seed................................................       0.08
Sunflower, seed..............................................       0.05
Sunflower, meal..............................................        0.2
Sunflower, refined oil.......................................        0.2
Vegetable, cucurbit, group 9.................................       0.09
                                * * * * *
------------------------------------------------------------------------
\1\There are no U.S. registrations as of 7/31/2008.

* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations for the residues of the fungicide, tebuconazole, 
alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-
triazole-1-ethanol in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Turnip, roots................................................        0.5
Turnip, tops.................................................        7.0
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-18625 Filed 8-12-08; 8:45 am]

BILLING CODE 6560-50-S
