[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