Tebuconazole; Pesticide Tolerances, 27748-27756 [E8-10506]
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Federal Register / Vol. 73, No. 94 / Wednesday, May 14, 2008 / Rules and Regulations
Access at: https://www.gpoaccess.gov/nara/
index.html.
Dated: May 8, 2008.
Margaret Spellings,
Secretary of Education.
BILLING CODE 4000–01–P
For the reasons discussed in the
preamble, the Secretary amends part 8
of title 34 of the Code of Federal
Regulations as follows:
ENVIRONMENTAL PROTECTION
AGENCY
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:
40 CFR Part 180
I. General Information
[EPA–HQ–OPP–2005–0097; FRL–8364–6]
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.
Education, 7th and D Streets, SW.,
ROB–3’’ and adding, in their place, the
words ‘‘Records Officer, Information
Policy and Standards Team, Regulatory
Information Management Services,
Office of Management, U.S. Department
of Education, 400 Maryland Avenue,
SW., room 9161, PCP’’.
(Catalog of Federal Domestic Assistance
Number does not apply.)
List of Subjects in 34 CFR Part 8
Courts, Government employees,
Reporting and recordkeeping
requirements.
[FR Doc. E8–10775 Filed 5–13–08; 8:45 am]
I
PART 8—DEMANDS FOR TESTIMONY
OR RECORDS IN LEGAL
PROCEEDINGS
1. The authority citation for part 8
continues to read as follows:
I
Authority: 5 U.S.C. 301; 5 U.S.C. 552; 20
U.S.C. 3474, unless otherwise noted.
§ 8.1
[Amended]
2. The introductory text of § 8.1(a) is
amended by removing the words ‘‘if the
Department or any departmental
employee’’ and adding, in their place,
the words ‘‘when the Department or any
employee of the Department’’.
I
§ 8.2
[Amended]
3. The definition of ‘‘Employee’’ in
§ 8.2 is amended by adding the words
‘‘or former’’ between the words
‘‘current’’ and ‘‘employee’’.
I
§ 8.3
[Amended]
4. Section 8.3 is amended by:
A. In the introductory text of
paragraph (a), removing the words ‘‘or
former employee,’’.
I B. In paragraph (a)(2), removing the
words ‘‘and why the information sought
is unavailable by any other means’’ and
adding, in their place, the words ‘‘, why
the information sought is unavailable by
any other means, and the reason why
the release of the information would not
be contrary to an interest of the
Department or the United States’’.
I C. In paragraph (b), removing the
words ‘‘or former employee’’ each time
they appear.
I D. In paragraph (b), removing the
words ‘‘room 4083, FOB–6,’’ and
adding, in their place, the words ‘‘room
6E300, Lyndon Baines Johnson
Building,’’.
I E. In paragraph (c), removing the
words ‘‘or former employee’’.
I F. In paragraph (c), removing the
words ‘‘Records Management Branch
Chief, Office of Information Resources
Management, U.S. Department of
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Tebuconazole; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of tebuconazole
in or on wheat, barley, and tree nuts.
Bayer CropScience LP requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
14, 2008. Objections and requests for
hearings must be received on or before
July 14, 2008, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0097. To access the
electronic docket, go to https://
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
https://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
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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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://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
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aspect of this regulation and may also
request a hearing on those objections.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2005–0097 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before July 14, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2005–0097, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of May 18,
2005 (70 FR 28257) (FRL–7708–5), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 7F4895) by Bayer
CropScience LP, P.O. Box 12014, 2 T.W.
Alexander Drive, Research Triangle
Park, NC 27709. The petition requested
that 40 CFR 180.474 be amended by
establishing tolerances for residues of
the fungicide tebuconazole, alpha-[2-(4Chlorophenyl)ethyl]-alpha-(1,1dimethylethyl)-1H-1,2,4-triazole-1ethanol, in or on food commodities nut,
tree, group 14 at 0.05 ppm; almond,
hulls at 5.0 ppm; pistachio at 0.05 ppm;
barley, hay at 6.0 ppm; barley, straw at
1.4 ppm; wheat, forage at 3.0 ppm;
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wheat, hay at 6.0 ppm; wheat, straw at
1.4 ppm. That notice referenced a
summary of the petition prepared by
Bayer CropScience LP, the registrant,
which is available to the public in the
docket, https://www.regulations.gov.
Comments were received on the notice
of filing. EPA’s response to these
comments is discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA has
modified the proposed tolerances as
follows: Almond, hulls at 6.0 ppm;
barley, grain at 0.15 ppm, barley, hay at
7.0 ppm; barley, straw at 3.5 ppm;
wheat grain at 0.05 ppm, wheat, hay at
7.0 ppm; wheat, straw at 1.5 ppm; and
a separate pistachio tolerance is not
needed. The reason for these changes is
explained in Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue....’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerances for residues of tebuconazole.
EPA’s assessment of exposures and risks
associated with establishing tolerances
follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
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concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
Tebuconazole has low acute toxicity
by the oral or dermal route of exposure,
and moderate toxicity by the inhalation
route. It is not a dermal sensitizer or a
dermal irritant; however, it is slightly to
mildly irritating to the eye. The main
target organs are the liver, the adrenals,
the hematopoetic system and the
nervous system. Effects on these target
organs were seen in both rodent and
non-rodent species. In addition, ocular
lesions are seen in dogs (including
lenticular degeneration and increased
cataract formation) following
subchronic or chronic exposure.
Oral administration of tebuconazole
caused developmental toxicity in all
species evaluated (rat, rabbit, and
mouse), with the most prominent effects
seen in the developing nervous system.
In the available toxicity studies on
tebuconazole, there was no
toxicologically significant evidence of
endocrine disruptor effects.
Tebuconazole was classified as a Group
C - possible human carcinogen, based
on an increase in the incidence of
hepatocellular adenomas, carcinomas
and combined adenomas/carcinomas in
male and female mice. Submitted
mutagenicity studies did not
demonstrate any evidence of mutagenic
potential for tebuconazole.
Tebuconazole shares common
metabolites with other triazolederivative chemicals, including free
triazole (1,2,4-triazole) and triazoleconjugated plant metabolites (such as
triazole alanine). These common
metabolites have been the subject of
separate risk assessments.
Specific information on the studies
received and the nature of the adverse
effects caused by tebuconazole as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
entitled Tebuconazole: Human Health
Risk Assessment to support tolerances
in/on Asparagus, Barley, Beans, Beets,
Brassica leafy greens, Bulb Vegetables,
Coffee (import), Commercial
Ornamentals, Corn, Cotton, Cucurbits,
Hops, Lychee, Mango, Okra, Pome fruit,
Soybean, Stone fruit, Sunflower, Tree
Nut Crop Group, Turf, Turnips and
Wheat, pages 79–107 in docket ID
number EPA–HQ–OPP–2005-0097.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
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(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a Benchmark Dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and
chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for tebuconazole used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1. — SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TEBUCONAZOLE FOR USE IN DIETARY AND NONOCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS
Exposure/Scenario
Point of Departure
Uncertainty/FQPA Safety Factors
RfD, PAD, Level of Concern for Risk Assessment
Study and Toxicological Effects
LOAEL = 8.8 mg/kg/day
UF = 300
UFA= 10x
UFH=10x
FQPA(UFL)= 3x
Acute RfD = 0.029 mg/
kg/day
aPAD = 0.029 mg/kg/
day
Developmental
Neurotoxicity
Study - Rat.
LOAEL = 8.8 mg/kg/day based on
decreases in body weights, absolute brain weights, brain
measurements and motor activity in offspring.
Chronic Dietary (All Populations)
LOAEL = 8.8 mg/kg/day
UF = 300
UFA= 10x
UFH=10x
FQPA(UFL)= 3x
Chronic RfD = 0.029mg/
kg/day
cPAD =0.029 mg/kg/day
Developmental
Neurotoxicity
Study - Rat.
LOAEL = 8.8 mg/kg/day based on
decreases in body weights, absolute brain weights, brain
measurements and motor activity in offspring.
Incidental Oral Short-/Intermediate-Term (1-30
days/1-6 months)
LOAEL = 8.8 mg/kg/day
UF = 300
UFA= 10x
UFH=10x
FQPA(UFL)= 3x
Residential LOC for
MOE = 300
Developmental
Neurotoxicity
Study - Rat.
LOAEL = 8.8 mg/kg/day based on
decreases in body weights, absolute brain weights, brain
measurements and motor activity in offspring.
Dermal Short-/Intermediate-Term (1-30
days/1-6 months)
LOAEL = 8.8 mg/kg/day
UF = 300
UFA= 10x
UFH=10x
FQPA (UFL)= 3x
DAF = 23.1%
Residential LOC for
MOE = 300
Developmental
Neurotoxicity
Study - Rat.
LOAEL = 8.8 mg/kg/day based on
decreases in body weights, absolute brain weights, brain
measurements and motor activity in offspring.
Inhalation Short-/Intermediate-Term (1-30
days/1-6 months)
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Acute Dietary (General
Population, including
Infants and Children)
LOAEL = 8.8 mg/kg/day
UF = 300
UFA= 10x
UFH=10x
FQPA (UFL)= 3x
Inhalation and oral toxicity are assumed to
be equivalent
Residential LOC for
MOE = 300
Developmental
Neurotoxicity
Study - Rat.
LOAEL = 8.8 mg/kg/day based on
decreases in body weights, absolute brain weights, brain
measurements and motor activity in offspring.
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TABLE 1. — SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TEBUCONAZOLE FOR USE IN DIETARY AND NONOCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS—Continued
Exposure/Scenario
Cancer (oral, dermal, inhalation)
Point of Departure
Uncertainty/FQPA Safety Factors
RfD, PAD, Level of Concern for Risk Assessment
Study and Toxicological Effects
Classification: Group C- possible human carcinogen based on statistically significant increase in the incidence of
hepatocellular adenoma, carcinoma, and combined adenoma/carcinomas in both sexes of NMRI mice. Considering
that there was no evidence of carcinogenicity in rats, there was no evidence of genotoxicity for tebuconazole, and
tumors were only seen at a high and excessively toxic dose in mice, EPA concluded that the chronic RfD would be
protective of any potential carcinogenic effect. The chronic RfD value is 0.029 mg/kg/day which is approximately
9600 fold lower than the dose that would induce liver tumors (279 mg/kg/day).
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Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect
level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. FQPA
SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
level of concern. N/A = not applicable. DAF = dermal absorption factor.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to tebuconazole, EPA
considered exposure under the
petitioned-for tolerances, including
other pending petitions, as well as all
existing tebuconazole tolerances in (40
CFR 180.474). EPA assessed dietary
exposures from tebuconazole in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1–day or single
exposure.
In estimating acute dietary exposure,
EPA used food consumption
information from the United States
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels
in food, anticipated residues for
bananas, grapes, raisins, nectarines,
peaches and peanut butter were derived
using the latest USDA Pesticide Data
Program (PDP) monitoring data from
2002- 2006. Anticipated residues for all
other registered and proposed food
commodities were based on field trial
data. For uses associated with PP
7F4895, 100% Crop treated was
assumed. DEEM (ver. 7.81) default
processing factors were assumed for
processed commodities associated with
petition 7F4895. For several other uses
EPA used percent crop treated (PCT)
data as specified in Unit III.C.1.iv.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the same assumptions as
stated in Unit III. C.1.i. for acute
exposure.
iii. Cancer. As explained in Unit
III.B., the chronic risk assessment is
considered to be protective of any
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cancer effects; therefore, a separate
quantitative cancer dietary risk
assessment was not conducted.
iv. Anticipated residue and PCT
information. Section 408(b)(2)(E) of
FFDCA authorizes EPA to use available
data and information on the anticipated
residue levels of pesticide residues in
food and the actual levels of pesticide
residues that have been measured in
food. If EPA relies on such information,
EPA must require pursuant to FFDCA
section 408(f)(1) that data be provided 5
years after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if:
Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
Condition c: Data are available on
pesticide use and food consumption in
a particular area, the exposure estimate
does not understate exposure for the
population in such area.
In addition, the Agency must provide
for periodic evaluation of any estimates
used. To provide for the periodic
evaluation of the estimate of PCT as
required by FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
The Agency used PCT information for
tebuconazole on grapes, grape, raisin,
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nectarine, oats, peach, and peanuts. The
PCT for each crop is as follows: Grapes:
25%; grape, raisin: 25%; nectarine 25%;
oats 2.5%; peach: 20%; and peanuts
45%.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6 years. EPA uses an average PCT
for chronic dietary risk analysis. The
average PCT figure for each existing use
is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
nearest 5%, except for those situations
in which the average PCT is less than
one. In those cases, 1% is used as the
average PCT and 2.5% is used as the
maximum PCT. EPA uses a maximum
PCT for acute dietary risk analysis. The
maximum PCT figure is the highest
observed maximum value reported
within the recent 6 years of available
public and private market survey data
for the existing use and rounded up to
the nearest multiple of 5%.
The Agency used projected percent
crop treated (PPCT) information for
tebuconazole on cherries (pre-harvest)
and cherries (post-harvest). The PCT for
each crop is as follows: Cherries, preharvest: acute assessment 42%, chronic
assessment 37%; Cherries, post-harvest:
acute assessment 100%, chronic
assessment 66%. EPA estimates PPCT
for a new pesticide use by assuming that
its actual PCT during the initial five
years of use on a specific use site will
not exceed the recent PCT of the market
leader (i.e., the one with the greatest
PCT) on that site. An average market
leader PCT, based on three recent
surveys of pesticide usage, if available,
is used for chronic risk assessment,
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while the maximum PCT from the same
three recent surveys, if available, is used
for acute risk assessment. The average
and maximum market leader PCTs may
each be based on one or two surveys if
three are not available. Comparisons are
only made among pesticides of the same
pesticide types (i.e., the leading
fungicide on the use site is selected for
comparison with the new fungicide).
The market leader PCTs used to
determine the average and the
maximum may be each for the same
pesticide or for different pesticides
since the same or different pesticides
may dominate for each year. Typically,
EPA uses USDA/NASS as the source for
raw PCT data because it is publicly
available. When a specific use site is not
surveyed by USDA/NASS, EPA uses
other sources including proprietary
data.
An estimated PPCT, based on the
average PCT of the market leaders, is
appropriate for use in chronic dietary
risk assessment, and an estimated PPCT,
based on the maximum PCT of the
market leaders, is appropriate for use in
acute dietary risk assessment. This
method of estimating PPCTs for a new
use of a registered pesticide or a new
pesticide produces high-end estimates
that are unlikely, in most cases, to be
exceeded during the initial five years of
actual use. Predominant factors that
bear on whether the PPCTs could be
exceeded may include PCTs of similar
chemistries, pests controlled by
alternatives, pest prevalence in the
market and other factors. All relevant
information currently available for
predominant factors have been
considered for tebuconazole on cherries,
resulting in adjustments to the initial
estimates for three crops to account for
lack of confidence in projections based
on less than three observations, old data
and/or data based on expert opinion.
The Agency believes that the three
conditions discussed in Unit III.C.1.iv.
have been met. With respect to
Condition a, PCT estimates are derived
from Federal and private market survey
data, which are reliable and have a valid
basis, or conservative estimates based
on information from agricultural
experts. The Agency is reasonably
certain that the percentage of the food
treated is not likely to be an
underestimation. As to Conditions b and
c, regional consumption information
and consumption information for
significant subpopulations is taken into
account through EPA’s computer-based
model for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
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exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available reliable information on
the regional consumption of food to
which tebuconazole may be applied in
a particular area.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for tebuconazole in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
tebuconazole. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://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 (SCIGROW) 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 nonoccupational, 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
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postapplication exposures to adults
during golfing and children playing on
treated wood structures are also
possible. Children may also be exposed
via the incidental oral route when
playing on treated wood structures.
Long-term exposure is not expected. As
a result, risk assessments have been
completed for residential handler
scenarios as well as residential
postapplication scenarios.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Tebuconazole is a member of the
triazole-containing class of pesticides.
Although conazoles act similarly in
plants (fungi) by inhibiting ergosterol
biosynthesis, there is not necessarily a
relationship between their pesticidal
activity and their mechanism of toxicity
in mammals. Structural similarities do
not constitute a common mechanism of
toxicity. Evidence is needed to establish
that the chemicals operate by the same,
or essentially the same, sequence of
major biochemical events. In conazoles,
however, a variable pattern of
toxicological responses is found. Some
are hepatotoxic and hepatocarcinogenic
in mice. Some induce thyroid tumors in
rats. Some induce developmental,
reproductive, and neurological effects in
rodents. Furthermore, the conazoles
produce a diverse range of biochemical
events including altered cholesterol
levels, stress responses, and altered
DNA methylation. It is not clearly
understood whether these biochemical
events are directly connected to their
toxicological outcomes. Thus, there is
currently no evidence to indicate that
conazoles share common mechanisms of
toxicity and EPA is not following a
cumulative risk approach based on a
common mechanism of toxicity for the
conazoles. For information regarding
EPA’s procedures for cumulating effects
from substances found to have a
common mechanism of toxicity, see
EPA’s website at https://www.epa.gov/
pesticides/cumulative.
Triazole-derived pesticides can form
the common metabolite 1,2,4-triazole
and two triazole conjugates (triazole
alanine and triazole acetic acid). To
support existing tolerances and to
establish new tolerances for triazolederivative pesticides, including
tebuconazole, EPA conducted a human
health risk assessment for exposure to
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1,2,4-triazole, triazole alanine, and
triazole acetic acid resulting from the
use of all current and pending uses of
any triazole-derived fungicide as of
September 1, 2005. The risk assessment
is a highly conservative, screening-level
evaluation in terms of hazards
associated with common metabolites
(e.g., use of a maximum combination of
uncertainty factors) and potential
dietary and non-dietary exposures (i.e.,
high end estimates of both dietary and
non-dietary exposures). In addition, the
Agency retained the additional 10X
FQPA safety factor for the protection of
infants and children. The assessment
includes evaluations of risks for various
subgroups, including those comprised
of infants and children. The Agency’s
September 1, 2005 risk assessment can
be found in the propiconazole
reregistration docket at https://
www.regulations.gov (Docket ID EPA–
HQ–OPP–2005–0497). An addendum to
the risk assessment, Dietary Exposure
Assessments for the Common Triazole
Metabolites 1,2,4-triazole,
Triazolylalanine, Triazolylacetic Acid
and Triazolylypyruvic Acid; Updated to
Include New Uses of Fenbuconazole,
Ipconazole, Metconazole, Tebuconazole,
and Uniconazole can be found at https://
www.regulations.gov in docket ID EPA–
HQ–OPP–2005–0097.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(c) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA safety factor (SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
The toxicity database for tebuconazole
is complete, and includes prenatal
developmental toxicity studies in three
species (mouse, rat, and rabbit), a
reproductive toxicity study in rats, acute
and subchronic neurotoxicity studies in
rats, and a developmental neurotoxicity
study in rats. The data from prenatal
developmental toxicity studies in mice
and a developmental neurotoxicity
(DNT) study in rats indicated an
increased quantitative and qualitative
susceptibility following in utero
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exposure to tebuconazole. The NOAELs/
LOAELs for developmental toxicity in
the mouse study were found at dose
levels less than those that induces
maternal toxicity or in the presence of
slight maternal toxicity. In the DNT
study, the LOAEL at which
developmental toxicity was seen was
below the NOAEL for maternal animals.
No NOAEL was identified for the
offspring in this study. There was no
indication of increased quantitative
susceptibility in the rat and rabbit
developmental toxicity studies, the
NOAELs for developmental toxicity
were comparable to or higher than the
NOAELs for maternal toxicity. In all
three species, however, there was
indication of increased qualitative
susceptibility. For most studies,
minimal maternal toxicity was seen at
the LOAEL (consisting of increases in
hematological findings in mice,
increased liver weights in rabbits and
rats, and decreased body weight gain/
food consumption in rats) and did not
increase substantially in severity at
higher doses; however, there was more
concern for the developmental effects at
each LOAEL which included increases
in runts, increased fetal loss, and
malformations in mice, increased
skeletal variations in rats, and increased
fetal loss and frank malformations in
rabbits. Additionally, more severe
developmental effects (including frank
malformations) were seen at higher
doses in mice, rats and rabbits. In the
developmental neurotoxicity study,
maternal toxicity was seen only at the
high dose (decreased body weights,
body weight gains, and food
consumption, prolonged gestation with
mortality, and increased number of dead
fetuses), while offspring toxicity
(including decreases in body weight,
brain weight, brain measurements and
functional activities) was seen at all
doses.
Available data indicated greater
sensitivity of the developing organism
to exposure to tebuconazole, with the
exception of the effects seen in the DNT
study, the degree of concern is low and
there are no residual uncertainties
because the toxic endpoints in the preand post-natal developmental toxicity
studies were well characterized with
clear NOAELs established and the
endpoint used for all risk assessments is
protective of the effects seen in these
studies.
There is concern with regard to the
DNT study because of the failure to
achieve a NOAEL in that study. This
concern is addressed by a retention of
FQPA SF in the form of UFL of 3X.
Reduction of the FQPA safety factor
from 10 to 3X is based on a Benchmark
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Dose (BMD) analysis of the datasets
relevant to the adverse offspring effects
(decreased body weight and brain
weight) seen at the LOAEL in the DNT
study. All of the BMDLs (the lower limit
of a one-sided 95% confidence interval
on the BMD) modeled successfully on
statistically significant effects are 1-2X
lower than the LOAEL. The results
indicate that an extrapolated NOAEL is
not likely to be 10X lower than the
LOAEL and that use of a FQPA safety
factor of 3X would not underestimate
risk. Using a 3X FQPA safety factor in
the risk assessment (8.8 mg/kg/day ÷ 3x
= 2.9 mg/kg/day) is further supported by
other studies in the tebuconazole
toxicity database (with the lowest
NOAELs being 3 and 2.9 mg/kg/day,
from a developmental toxicity study in
mice and a chronic toxicity study in
dogs, respectively [respective LOAELs
10 and 4.5 mg/kg/day]).
3. Conclusion. The Agency has
determined that reliable data show that
it would be safe for infants and children
to reduce the FQPA SF to 3x for all
potential exposure scenarios. That
decision is based on the following
findings:
i. The toxicity database for
tebuconazole is complete and includes
an acceptable rat developmental
neurotoxicity study.
ii. Although there is qualitative
evidence of increased susceptibility in
the prenatal developmental studies in
rats, mice, and rabbits, and in the 2generation reproduction study in rats,
EPA did not identify any residual
uncertainties or concerns with regard to
these studies after establishing toxicity
endpoints and traditional UFs to be
used in the risk assessment of
tebuconazole.
iii. A concern was identified with
regard to the failure to identify a
NOAEL for the development effects
found in the DNT study. A FQPA safety
factor of 3X was found sufficient to
protect infants and children based on
the BMD analysis summarized in Unit
III.D.2.
iv. There are no residual uncertainties
identified in the exposure databases.
Although the acute and chronic food
exposure assessments are refined, EPA
believes that the assessments are based
on reliable data and will not
underestimate exposure/risk. The
drinking water estimates were derived
from conservative screening models.
The residential exposure assessment
utilizes reasonable high-end variables
set out in EPA’s Occupational/
Residential Exposure SOPs (Standard
Operating Procedures). The aggregate
assessment is based upon reasonable
worst-case residential assumptions, and
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is also not likely to underestimate
exposure/risk to any subpopulation,
including those comprised of infants
and children.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
tebuconazole will occupy 53% of the
aPAD for the population group (all
infants less than 1 year old) receiving
the greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to tebuconazole from food
and water will utilize 4% of the cPAD
for the U.S. population and 11% of the
cPAD for the most highly exposed
population group (infants less than 1
year old).
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Tebuconazole is
currently registered for uses that could
result in short-term residential exposure
and the Agency has determined that it
is appropriate to aggregate chronic
exposure through food and water with
short-term residential exposures to
tebuconazole.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded that the
short-term aggregate MOE from dietary
exposure (food + drinking water) and
non-occupational/residential handler
exposure for adults using a hose-end
sprayer on ornamentals is 400. The
short-term aggregate MOE from dietary
exposure and exposure from golfing is
1,800. The short-term aggregate MOE to
children from dietary exposure and
exposure from wood surfaces treated at
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the above ground use rate is 530. The
short-term aggregate MOE to children
from dietary exposure and exposure to
wood surfaces treated at the below
ground use rate is 230. The combined
and aggregate MOEs for wood treated for
below ground uses exceed the Agency’s
LOC of 300, and indicate a potential risk
of concern. However, the MOE of 230 is
based on the assumption that 100% of
a child’s exposure is to below ground
wood. In reality, the probability and
frequency of children contacting wood
intended for below ground use is
reasonably assumed to be small and
incidental compared to wood intended
for above ground uses. Treated wood
intended for below ground use is the 4
inch X 4 inch support beams for decks
and playsets, while treated wood
intended for above ground use is the
decking and connecting wood.
Therefore, the majority of contact is
reasonably assumed to be to wood
intended for above ground uses. The
combined/aggregate MOEs for wood
treated for above ground uses does not
exceed the LOC, and exposure to above
ground wood is expected to more
closely represent actual exposures to
children. Therefore, the Agency
considers this assessment to be a
conservative screening level assessment.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Tebuconazole is currently registered for
uses that could result in intermediateterm residential exposure and the
Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water with
intermediate-term residential exposures
to tebuconazole.
Since the POD, relevant exposure
scenarios and exposure assumptions
used for intermediate-term aggregate
risk assessments are the same as those
used for short-term aggregate risk
assessments, the short-term aggregate
risk assessments represent and are
protective of both short- and
intermediate-term exposure durations.
5. Aggregate cancer risk for U.S.
population. Tebuconazole is classified
as a Group C Carcinogen-Possible
Human Carcinogen based on
statistically significant increase in the
incidence of hepatocellular adenoma,
carcinoma, and combined adenoma/
carcinomas in both sexes of NMRI mice.
The Agency believes that the chronic
RfD is protective of the cancer effects
because the increased incidences of
hepatocellular adenoma, carcinomas,
and combined adenoma/carcinoma were
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seen only at the highest dose 1,500 ppm
(279 mg/kg/day for males and 365.5 mg/
kg/day for females) in the mouse
carcinogenicity study. The dose was
considered excessive. There was no
evidence of carcinogenicity in rats, and
no evidence of genotoxicity for
tebuconazole. The chronic RfD value is
0.029 mg/kg/day which is
approximately 9,600 fold lower than the
dose that would induce liver tumors
(279 mg/kg/day).
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population or to infants and children
from aggregate exposure to tebuconazole
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate GC/NPD and LC/MS/MS
methods are available for both collecting
and enforcing tolerances for
tebuconazole and its metabolites in
plant commodities, livestock matrices
and processing studies. The methods
have been adequately validated by an
independent laboratory in conjunction
with a previous petition. The method
may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
B. International Residue Limits
There are currently Codex, Canadian
and Mexican maximum residue limits
(MRLs) for residues of tebuconazole in/
on a variety of plant and livestock
commodities. The tolerance definition
for residues in plants is tebuconazole,
per se, for Codex, Canada, and Mexico.
For livestock commodities, the tolerance
expression is for the combined residues
of tebuconazole and HWG 2061 in the
U.S. and Canada, and tebuconazole, per
se, for Codex. Where possible, the
proposed tolerances levels have been
harmonized with the MRLs from
Canada, Mexico, and Codex
C. Response to Comments
The Agency received a comment from
a citizen of New Jersey. The commenter
questioned the necessity of using
taxpayer money through the agency of
the Interregional Research Project No. 4
to develop pesticides, challenged the
appropriateness of conducting some of
the tebuconazole field trials outside of
the United States, expressed concern
over whether specific warnings were
given to residents of New Jersey prior to
conducting field trials in that State, and
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worried that students at Rutgers
University may have been injured in the
tebuconazole toxicological tests on
animals that were performed at that
facility.
In response, EPA notes that although
IR-4 has petitioned for other
tebuconazole tolerances it was not a
petitioner as to the tolerances being
established today. The notice cited by
the commenter contained petitions from
both IR-4 and a pesticide manufacturer.
EPA is only acting today on the petition
from the pesticide manufacturer. IR-4
was established by the U.S. Department
of Agriculture to help minor acreage,
specialty crop producers obtain EPA
tolerances and new registered uses of
pesticides. As to the commenter’s
concern with field trials that were
conducted in countries other than the
United States, the field trials that are
referenced do not involve the tolerances
being acted on in this rulemaking. EPA
notes, however, that frequently field
trials are conducted in other countries
as well as in the United States so that
EPA can understand the range of
pesticide residues that may be present
on a food. Similarly, the field trial
conducted in New Jersey was for a
tolerance that is not involved in today’s
action. EPA’s regulations governing use
of pesticides under experimental use
permits can be found at 40 CFR part
172. EPA also has regulations governing
the toxicological data testing
laboratories that are designed to insure
data quality (40 CFR part 160). Federal
jurisdiction concerning the safety of
workers in testing laboratories would be
under the Occupational Safety and
Health Administration in the U.S.
Department of Labor. EPA has
responded to similar comments from
this commenter on previous occasions.
Refer to 70 FR 37686 (June 30, 2005), 70
FR 1354 (January 7, 2005), and 69 FR
63083 (October 29, 2004).
D. Revisions to Petitioned-For
Tolerances
Based upon review of the data
supporting the petition, EPA
determined that the proposed tolerances
should be revised as follows: Almond,
hulls increased from 5.0 ppm to 6.0
ppm; barley, hay increased from 6.0
ppm to 7.0 ppm; barley, straw increased
from 1.4 ppm to 3.5 ppm; wheat, hay
increased from 6.0 to 7.0 ppm; and
wheat, straw increased from 1.4 ppm to
1.5 ppm. EPA revised these tolerance
levels based on analysis of the residue
field trial data using the Agency’s
Tolerance Spreadsheet in accordance
with the Agency’s Guidance for Setting
Pesticide Tolerances Based on Field
Trial Data Standard Operating
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Procedure (SOP). Additionally,
tolerances were not proposed, but are
required for barley, grain at 0.15 ppm
based on detectable residues using the
Agency’s Tolerance Spreadsheet and
wheat, grain at 0.05 ppm, because
tolerances are needed even with
residues are non-detectable. Also, a
separate tolerance is not needed for
pistachios, as they are considered under
the nut, tree, group 14.
V. Conclusion
Therefore, tolerances are established
for residues of the fungicide
tebuconazole, alpha-[2-(4Chlorophenyl)ethyl]-alpha-(1,1dimethylethyl)-1H-1,2,4-triazole-1ethanol, in or on food commodities nut,
tree, group 14 at 0.05 ppm; almond,
hulls at 6.0 ppm; barley, grain at 0.15
ppm; barley, hay at 7.0 ppm; barley,
straw at 3.5 ppm; wheat, forage at 3.0
ppm; wheat, grain at 0.05 ppm; wheat,
hay at 7.0 ppm; and wheat, straw at 1.5
ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
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27755
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 2, 2008.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
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PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.474 is amended in
paragraph (a)(1) in the table by
alphabetically adding the commodities
Almond, hulls and Nut, tree, group 14
and by revising the following
commodities to read as follows:
I
§ 180.474 Tebuconazole; tolerances for
residues.
(a) *
*
*
Commodity
Parts per million
Almond, hulls ..................
*
*
*
*
6.0
*
Barley, grain ...................
Barley, hay ......................
Barley, straw ...................
*
*
*
*
0.15
7.0
3.5
*
Nut, tree, group 14 .........
*
*
*
*
0.05
*
Wheat,
Wheat,
Wheat,
Wheat,
*
forage .................
grain ...................
hay .....................
straw ...................
*
*
*
3.0
0.05
7.0
1.5
*
[FR Doc. E8–10506 Filed 5–13–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0149; [FRL–8362–9]
Cyproconazole; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
rfrederick on PROD1PC67 with RULES
AGENCY:
SUMMARY: This regulation establishes
tolerances for the free and conjugated
residues of cyproconazole, a-(4chlorophenyl)-a-(1-cyclopropylethyl)1H-1,2,4-triazole-1-ethanol in or on
aspirated grain fractions; field corn,
forage, grain and stover; soybean, seed,
forage, hay and oil; wheat, forage, hay,
straw, grain, grain, milled by products;
fat of cattle, goat, horse and sheep; and
meat byproducts (except liver) of cattle,
goat, horse and sheep. Additionally, this
regulation establishes tolerances for
cyproconazole and its metabolite, d-(4chlorophenyl)-b,d-dihydroxy-g-methyl1H-1,2,4-triazole-1-hexenoic acid in or
on milk and for cyproconazole and its
metabolite, 2-(4-chlorophenyl)-3cyclopropyl-1-[1,2,4]triazol-1-yl-butane2,3-diol in or on liver of cattle, goat,
VerDate Aug<31>2005
14:57 May 13, 2008
Jkt 214001
hog, horse, and sheep. Syngenta Crop
Protection, Inc., requested this tolerance
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA).
DATES: This regulation is effective May
14, 2008. Objections and requests for
hearings must be received on or before
July 14, 2008, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0149. To access the
electronic docket, go to https://
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
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Mary L. Waller, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9354; e-mail address:
waller.mary@epa.gov.
ADDRESSES:
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
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, any
person may file an objection to any
aspect of this regulation and may also
request a hearing on those objections.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–0149 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before July 14, 2008.
E:\FR\FM\14MYR1.SGM
14MYR1
Agencies
[Federal Register Volume 73, Number 94 (Wednesday, May 14, 2008)]
[Rules and Regulations]
[Pages 27748-27756]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10506]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0097; FRL-8364-6]
Tebuconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
tebuconazole in or on wheat, barley, and tree nuts. Bayer CropScience
LP requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective May 14, 2008. Objections and
requests for hearings must be received on or before July 14, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0097. To access the
electronic docket, go to https://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 https://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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, any person may file an objection to
any
[[Page 27749]]
aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2005-0097 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before July 14, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2005-0097, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of May 18, 2005 (70 FR 28257) (FRL-7708-5),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 7F4895)
by Bayer CropScience LP, P.O. Box 12014, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.474 be amended by establishing tolerances for residues of the
fungicide tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on food commodities
nut, tree, group 14 at 0.05 ppm; almond, hulls at 5.0 ppm; pistachio at
0.05 ppm; barley, hay at 6.0 ppm; barley, straw at 1.4 ppm; wheat,
forage at 3.0 ppm; wheat, hay at 6.0 ppm; wheat, straw at 1.4 ppm. That
notice referenced a summary of the petition prepared by Bayer
CropScience LP, the registrant, which is available to the public in the
docket, https://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.C.
Based upon review of the data supporting the petition, EPA has
modified the proposed tolerances as follows: Almond, hulls at 6.0 ppm;
barley, grain at 0.15 ppm, barley, hay at 7.0 ppm; barley, straw at 3.5
ppm; wheat grain at 0.05 ppm, wheat, hay at 7.0 ppm; wheat, straw at
1.5 ppm; and a separate pistachio tolerance is not needed. The reason
for these changes is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of tebuconazole. EPA's assessment of exposures
and risks associated with establishing tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Tebuconazole has low acute toxicity by the oral or dermal route of
exposure, and moderate toxicity by the inhalation route. It is not a
dermal sensitizer or a dermal irritant; however, it is slightly to
mildly irritating to the eye. The main target organs are the liver, the
adrenals, the hematopoetic system and the nervous system. Effects on
these target organs were seen in both rodent and non-rodent species. In
addition, ocular lesions are seen in dogs (including lenticular
degeneration and increased cataract formation) following subchronic or
chronic exposure.
Oral administration of tebuconazole caused developmental toxicity
in all species evaluated (rat, rabbit, and mouse), with the most
prominent effects seen in the developing nervous system. In the
available toxicity studies on tebuconazole, there was no
toxicologically significant evidence of endocrine disruptor effects.
Tebuconazole was classified as a Group C - possible human carcinogen,
based on an increase in the incidence of hepatocellular adenomas,
carcinomas and combined adenomas/carcinomas in male and female mice.
Submitted mutagenicity studies did not demonstrate any evidence of
mutagenic potential for tebuconazole. Tebuconazole shares common
metabolites with other triazole-derivative chemicals, including free
triazole (1,2,4-triazole) and triazole-conjugated plant metabolites
(such as triazole alanine). These common metabolites have been the
subject of separate risk assessments.
Specific information on the studies received and the nature of the
adverse effects caused by tebuconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://
www.regulations.gov in document entitled Tebuconazole: Human Health
Risk Assessment to support tolerances in/on Asparagus, Barley, Beans,
Beets, Brassica leafy greens, Bulb Vegetables, Coffee (import),
Commercial Ornamentals, Corn, Cotton, Cucurbits, Hops, Lychee, Mango,
Okra, Pome fruit, Soybean, Stone fruit, Sunflower, Tree Nut Crop Group,
Turf, Turnips and Wheat, pages 79-107 in docket ID number EPA-HQ-OPP-
2005[dash]0097.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure
[[Page 27750]]
(POD) is identified as the basis for derivation of reference values for
risk assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for tebuconazole used for
human risk assessment is shown in Table 1 of this unit.
Table 1. -- Summary of Toxicological Doses and Endpoints for Tebuconazole for Use in Dietary and Non-
Occupational Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
RfD, PAD, Level of Study and
Exposure/Scenario Point of Departure Uncertainty/FQPA Concern for Risk Toxicological
Safety Factors Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General LOAEL = 8.8 mg/kg/ UFA= 10x Acute RfD = 0.029 Developmental
Population, including Infants day UFH=10x........... mg/kg/day Neurotoxicity
and Children) UF = 300.......... FQPA(UFL)= 3x..... aPAD = 0.029 mg/kg/ Study - Rat.
day. LOAEL = 8.8 mg/kg/
day based on
decreases in body
weights, absolute
brain weights,
brain
measurements and
motor activity in
offspring.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All LOAEL = 8.8 mg/kg/ UFA= 10x Chronic RfD = Developmental
Populations) day UFH=10x........... 0.029mg/kg/day Neurotoxicity
UF = 300.......... FQPA(UFL)= 3x..... cPAD =0.029 mg/kg/ Study - Rat.
day. LOAEL = 8.8 mg/kg/
day based on
decreases in body
weights, absolute
brain weights,
brain
measurements and
motor activity in
offspring.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-/ LOAEL = 8.8 mg/kg/ UFA= 10x Residential LOC Developmental
Intermediate-Term (1-30 days/1- day UFH=10x........... for MOE = 300 Neurotoxicity
6 months) UF = 300.......... FQPA(UFL)= 3x..... Study - Rat.
LOAEL = 8.8 mg/kg/
day based on
decreases in body
weights, absolute
brain weights,
brain
measurements and
motor activity in
offspring.
----------------------------------------------------------------------------------------------------------------
Dermal Short-/Intermediate-Term LOAEL = 8.8 mg/kg/ UFA= 10x Residential LOC Developmental
(1-30 days/1-6 months) day UFH=10x........... for MOE = 300 Neurotoxicity
UF = 300.......... FQPA (UFL)= 3x.... Study - Rat.
DAF = 23.1%....... LOAEL = 8.8 mg/kg/
day based on
decreases in body
weights, absolute
brain weights,
brain
measurements and
motor activity in
offspring.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-/Intermediate- LOAEL = 8.8 mg/kg/ UFA= 10x Residential LOC Developmental
Term (1-30 days/1-6 months) day UFH=10x........... for MOE = 300 Neurotoxicity
UF = 300.......... FQPA (UFL)= 3x.... Study - Rat.
Inhalation and LOAEL = 8.8 mg/kg/
oral toxicity are day based on
assumed to be decreases in body
equivalent. weights, absolute
brain weights,
brain
measurements and
motor activity in
offspring.
----------------------------------------------------------------------------------------------------------------
[[Page 27751]]
Cancer (oral, dermal, Classification: Group C- possible human carcinogen based on statistically
inhalation) significant increase in the incidence of hepatocellular adenoma, carcinoma,
and combined adenoma/carcinomas in both sexes of NMRI mice. Considering that
there was no evidence of carcinogenicity in rats, there was no evidence of
genotoxicity for tebuconazole, and tumors were only seen at a high and
excessively toxic dose in mice, EPA concluded that the chronic RfD would be
protective of any potential carcinogenic effect. The chronic RfD value is
0.029 mg/kg/day which is approximately 9600 fold lower than the dose that
would induce liver tumors (279 mg/kg/day).
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to
extrapolate a NOAEL. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic).
RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. DAF = dermal
absorption factor.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tebuconazole, EPA considered exposure under the petitioned-
for tolerances, including other pending petitions, as well as all
existing tebuconazole tolerances in (40 CFR 180.474). EPA assessed
dietary exposures from tebuconazole in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, anticipated residues
for bananas, grapes, raisins, nectarines, peaches and peanut butter
were derived using the latest USDA Pesticide Data Program (PDP)
monitoring data from 2002- 2006. Anticipated residues for all other
registered and proposed food commodities were based on field trial
data. For uses associated with PP 7F4895, 100% Crop treated was
assumed. DEEM (ver. 7.81) default processing factors were assumed for
processed commodities associated with petition 7F4895. For several
other uses EPA used percent crop treated (PCT) data as specified in
Unit III.C.1.iv.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the same assumptions as stated in Unit III. C.1.i.
for acute exposure.
iii. Cancer. As explained in Unit III.B., the chronic risk
assessment is considered to be protective of any cancer effects;
therefore, a separate quantitative cancer dietary risk assessment was
not conducted.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain the pesticide residue.
Condition b: The exposure estimate does not underestimate exposure
for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used PCT information for tebuconazole on grapes, grape,
raisin, nectarine, oats, peach, and peanuts. The PCT for each crop is
as follows: Grapes: 25%; grape, raisin: 25%; nectarine 25%; oats 2.5%;
peach: 20%; and peanuts 45%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
The Agency used projected percent crop treated (PPCT) information
for tebuconazole on cherries (pre-harvest) and cherries (post-harvest).
The PCT for each crop is as follows: Cherries, pre-harvest: acute
assessment 42%, chronic assessment 37%; Cherries, post-harvest: acute
assessment 100%, chronic assessment 66%. EPA estimates PPCT for a new
pesticide use by assuming that its actual PCT during the initial five
years of use on a specific use site will not exceed the recent PCT of
the market leader (i.e., the one with the greatest PCT) on that site.
An average market leader PCT, based on three recent surveys of
pesticide usage, if available, is used for chronic risk assessment,
[[Page 27752]]
while the maximum PCT from the same three recent surveys, if available,
is used for acute risk assessment. The average and maximum market
leader PCTs may each be based on one or two surveys if three are not
available. Comparisons are only made among pesticides of the same
pesticide types (i.e., the leading fungicide on the use site is
selected for comparison with the new fungicide). The market leader PCTs
used to determine the average and the maximum may be each for the same
pesticide or for different pesticides since the same or different
pesticides may dominate for each year. Typically, EPA uses USDA/NASS as
the source for raw PCT data because it is publicly available. When a
specific use site is not surveyed by USDA/NASS, EPA uses other sources
including proprietary data.
An estimated PPCT, based on the average PCT of the market leaders,
is appropriate for use in chronic dietary risk assessment, and an
estimated PPCT, based on the maximum PCT of the market leaders, is
appropriate for use in acute dietary risk assessment. This method of
estimating PPCTs for a new use of a registered pesticide or a new
pesticide produces high-end estimates that are unlikely, in most cases,
to be exceeded during the initial five years of actual use. Predominant
factors that bear on whether the PPCTs could be exceeded may include
PCTs of similar chemistries, pests controlled by alternatives, pest
prevalence in the market and other factors. All relevant information
currently available for predominant factors have been considered for
tebuconazole on cherries, resulting in adjustments to the initial
estimates for three crops to account for lack of confidence in
projections based on less than three observations, old data and/or data
based on expert opinion.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis, or conservative estimates based on
information from agricultural experts. The Agency is reasonably certain
that the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which tebuconazole may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for tebuconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of tebuconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model /Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
tebuconazole for acute exposures are estimated to be 78.5 parts per
billion (ppb) for surface water and 1.56 ppb for ground water. The
EDWCs for chronic, non-cancer are estimated to be 44.9 ppb for surface
water and 1.56 ppb for ground water. The EDWCs for chronic, cancer
exposures are estimated to be 32.3 ppb for surface water and 1.56 ppb
for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 78.5 ppb was used to
assess the contribution to drinking water. For the chronic dietary risk
assessment (which is protective of any possible cancer effects), the
water concentration value of 44.9 ppb was used to assess the
contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Tebuconazole is currently registered for uses that could result in
residential exposures. Short-term dermal and inhalation exposures are
possible for residential adult handlers mixing, loading, and applying
tebuconazole products outdoors to ornamental plants. Short- and
intermediate-term dermal postapplication exposures to adults during
golfing and children playing on treated wood structures are also
possible. Children may also be exposed via the incidental oral route
when playing on treated wood structures. Long-term exposure is not
expected. As a result, risk assessments have been completed for
residential handler scenarios as well as residential postapplication
scenarios.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Tebuconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events. In conazoles, however, a variable pattern of
toxicological responses is found. Some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's website at https://www.epa.gov/pesticides/
cumulative.
Triazole-derived pesticides can form the common metabolite 1,2,4-
triazole and two triazole conjugates (triazole alanine and triazole
acetic acid). To support existing tolerances and to establish new
tolerances for triazole-derivative pesticides, including tebuconazole,
EPA conducted a human health risk assessment for exposure to
[[Page 27753]]
1,2,4-triazole, triazole alanine, and triazole acetic acid resulting
from the use of all current and pending uses of any triazole-derived
fungicide as of September 1, 2005. The risk assessment is a highly
conservative, screening-level evaluation in terms of hazards associated
with common metabolites (e.g., use of a maximum combination of
uncertainty factors) and potential dietary and non-dietary exposures
(i.e., high end estimates of both dietary and non-dietary exposures).
In addition, the Agency retained the additional 10X FQPA safety factor
for the protection of infants and children. The assessment includes
evaluations of risks for various subgroups, including those comprised
of infants and children. The Agency's September 1, 2005 risk assessment
can be found in the propiconazole reregistration docket at https://
www.regulations.gov (Docket ID EPA-HQ-OPP-2005-0497). An addendum to
the risk assessment, Dietary Exposure Assessments for the Common
Triazole Metabolites 1,2,4-triazole, Triazolylalanine, Triazolylacetic
Acid and Triazolylypyruvic Acid; Updated to Include New Uses of
Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and Uniconazole
can be found at https://www.regulations.gov in docket ID EPA-HQ-OPP-
2005-0097.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The toxicity database for
tebuconazole is complete, and includes prenatal developmental toxicity
studies in three species (mouse, rat, and rabbit), a reproductive
toxicity study in rats, acute and subchronic neurotoxicity studies in
rats, and a developmental neurotoxicity study in rats. The data from
prenatal developmental toxicity studies in mice and a developmental
neurotoxicity (DNT) study in rats indicated an increased quantitative
and qualitative susceptibility following in utero exposure to
tebuconazole. The NOAELs/LOAELs for developmental toxicity in the mouse
study were found at dose levels less than those that induces maternal
toxicity or in the presence of slight maternal toxicity. In the DNT
study, the LOAEL at which developmental toxicity was seen was below the
NOAEL for maternal animals. No NOAEL was identified for the offspring
in this study. There was no indication of increased quantitative
susceptibility in the rat and rabbit developmental toxicity studies,
the NOAELs for developmental toxicity were comparable to or higher than
the NOAELs for maternal toxicity. In all three species, however, there
was indication of increased qualitative susceptibility. For most
studies, minimal maternal toxicity was seen at the LOAEL (consisting of
increases in hematological findings in mice, increased liver weights in
rabbits and rats, and decreased body weight gain/food consumption in
rats) and did not increase substantially in severity at higher doses;
however, there was more concern for the developmental effects at each
LOAEL which included increases in runts, increased fetal loss, and
malformations in mice, increased skeletal variations in rats, and
increased fetal loss and frank malformations in rabbits. Additionally,
more severe developmental effects (including frank malformations) were
seen at higher doses in mice, rats and rabbits. In the developmental
neurotoxicity study, maternal toxicity was seen only at the high dose
(decreased body weights, body weight gains, and food consumption,
prolonged gestation with mortality, and increased number of dead
fetuses), while offspring toxicity (including decreases in body weight,
brain weight, brain measurements and functional activities) was seen at
all doses.
Available data indicated greater sensitivity of the developing
organism to exposure to tebuconazole, with the exception of the effects
seen in the DNT study, the degree of concern is low and there are no
residual uncertainties because the toxic endpoints in the pre- and
post-natal developmental toxicity studies were well characterized with
clear NOAELs established and the endpoint used for all risk assessments
is protective of the effects seen in these studies.
There is concern with regard to the DNT study because of the
failure to achieve a NOAEL in that study. This concern is addressed by
a retention of FQPA SF in the form of UFL of 3X. Reduction
of the FQPA safety factor from 10 to 3X is based on a Benchmark Dose
(BMD) analysis of the datasets relevant to the adverse offspring
effects (decreased body weight and brain weight) seen at the LOAEL in
the DNT study. All of the BMDLs (the lower limit of a one-sided 95%
confidence interval on the BMD) modeled successfully on statistically
significant effects are 1-2X lower than the LOAEL. The results indicate
that an extrapolated NOAEL is not likely to be 10X lower than the LOAEL
and that use of a FQPA safety factor of 3X would not underestimate
risk. Using a 3X FQPA safety factor in the risk assessment (8.8 mg/kg/
day / 3x = 2.9 mg/kg/day) is further supported by other studies in the
tebuconazole toxicity database (with the lowest NOAELs being 3 and 2.9
mg/kg/day, from a developmental toxicity study in mice and a chronic
toxicity study in dogs, respectively [respective LOAELs 10 and 4.5 mg/
kg/day]).
3. Conclusion. The Agency has determined that reliable data show
that it would be safe for infants and children to reduce the FQPA SF to
3x for all potential exposure scenarios. That decision is based on the
following findings:
i. The toxicity database for tebuconazole is complete and includes
an acceptable rat developmental neurotoxicity study.
ii. Although there is qualitative evidence of increased
susceptibility in the prenatal developmental studies in rats, mice, and
rabbits, and in the 2-generation reproduction study in rats, EPA did
not identify any residual uncertainties or concerns with regard to
these studies after establishing toxicity endpoints and traditional UFs
to be used in the risk assessment of tebuconazole.
iii. A concern was identified with regard to the failure to
identify a NOAEL for the development effects found in the DNT study. A
FQPA safety factor of 3X was found sufficient to protect infants and
children based on the BMD analysis summarized in Unit III.D.2.
iv. There are no residual uncertainties identified in the exposure
databases. Although the acute and chronic food exposure assessments are
refined, EPA believes that the assessments are based on reliable data
and will not underestimate exposure/risk. The drinking water estimates
were derived from conservative screening models. The residential
exposure assessment utilizes reasonable high-end variables set out in
EPA's Occupational/Residential Exposure SOPs (Standard Operating
Procedures). The aggregate assessment is based upon reasonable worst-
case residential assumptions, and
[[Page 27754]]
is also not likely to underestimate exposure/risk to any subpopulation,
including those comprised of infants and children.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to tebuconazole will occupy 53% of the aPAD for the population group
(all infants less than 1 year old) receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
tebuconazole from food and water will utilize 4% of the cPAD for the
U.S. population and 11% of the cPAD for the most highly exposed
population group (infants less than 1 year old).
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Tebuconazole
is currently registered for uses that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to tebuconazole.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the short-term aggregate MOE
from dietary exposure (food + drinking water) and non-occupational/
residential handler exposure for adults using a hose-end sprayer on
ornamentals is 400. The short-term aggregate MOE from dietary exposure
and exposure from golfing is 1,800. The short-term aggregate MOE to
children from dietary exposure and exposure from wood surfaces treated
at the above ground use rate is 530. The short-term aggregate MOE to
children from dietary exposure and exposure to wood surfaces treated at
the below ground use rate is 230. The combined and aggregate MOEs for
wood treated for below ground uses exceed the Agency's LOC of 300, and
indicate a potential risk of concern. However, the MOE of 230 is based
on the assumption that 100% of a child's exposure is to below ground
wood. In reality, the probability and frequency of children contacting
wood intended for below ground use is reasonably assumed to be small
and incidental compared to wood intended for above ground uses. Treated
wood intended for below ground use is the 4 inch X 4 inch support beams
for decks and playsets, while treated wood intended for above ground
use is the decking and connecting wood. Therefore, the majority of
contact is reasonably assumed to be to wood intended for above ground
uses. The combined/aggregate MOEs for wood treated for above ground
uses does not exceed the LOC, and exposure to above ground wood is
expected to more closely represent actual exposures to children.
Therefore, the Agency considers this assessment to be a conservative
screening level assessment.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Tebuconazole is currently registered for uses that could result
in intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to tebuconazole.
Since the POD, relevant exposure scenarios and exposure assumptions
used for intermediate-term aggregate risk assessments are the same as
those used for short-term aggregate risk assessments, the short-term
aggregate risk assessments represent and are protective of both short-
and intermediate-term exposure durations.
5. Aggregate cancer risk for U.S. population. Tebuconazole is
classified as a Group C Carcinogen-Possible Human Carcinogen based on
statistically significant increase in the incidence of hepatocellular
adenoma, carcinoma, and combined adenoma/carcinomas in both sexes of
NMRI mice. The Agency believes that the chronic RfD is protective of
the cancer effects because the increased incidences of hepatocellular
adenoma, carcinomas, and combined adenoma/carcinoma were seen only at
the highest dose 1,500 ppm (279 mg/kg/day for males and 365.5 mg/kg/day
for females) in the mouse carcinogenicity study. The dose was
considered excessive. There was no evidence of carcinogenicity in rats,
and no evidence of genotoxicity for tebuconazole. The chronic RfD value
is 0.029 mg/kg/day which is approximately 9,600 fold lower than the
dose that would induce liver tumors (279 mg/kg/day).
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to tebuconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate GC/NPD and LC/MS/MS methods are available for both
collecting and enforcing tolerances for tebuconazole and its
metabolites in plant commodities, livestock matrices and processing
studies. The methods have been adequately validated by an independent
laboratory in conjunction with a previous petition. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are currently Codex, Canadian and Mexican maximum residue
limits (MRLs) for residues of tebuconazole in/on a variety of plant and
livestock commodities. The tolerance definition for residues in plants
is tebuconazole, per se, for Codex, Canada, and Mexico. For livestock
commodities, the tolerance expression is for the combined residues of
tebuconazole and HWG 2061 in the U.S. and Canada, and tebuconazole, per
se, for Codex. Where possible, the proposed tolerances levels have been
harmonized with the MRLs from Canada, Mexico, and Codex
C. Response to Comments
The Agency received a comment from a citizen of New Jersey. The
commenter questioned the necessity of using taxpayer money through the
agency of the Interregional Research Project No. 4 to develop
pesticides, challenged the appropriateness of conducting some of the
tebuconazole field trials outside of the United States, expressed
concern over whether specific warnings were given to residents of New
Jersey prior to conducting field trials in that State, and
[[Page 27755]]
worried that students at Rutgers University may have been injured in
the tebuconazole toxicological tests on animals that were performed at
that facility.
In response, EPA notes that although IR-4 has petitioned for other
tebuconazole tolerances it was not a petitioner as to the tolerances
being established today. The notice cited by the commenter contained
petitions from both IR-4 and a pesticide manufacturer. EPA is only
acting today on the petition from the pesticide manufacturer. IR-4 was
established by the U.S. Department of Agriculture to help minor
acreage, specialty crop producers obtain EPA tolerances and new
registered uses of pesticides. As to the commenter's concern with field
trials that were conducted in countries other than the United States,
the field trials that are referenced do not involve the tolerances
being acted on in this rulemaking. EPA notes, however, that frequently
field trials are conducted in other countries as well as in the United
States so that EPA can understand the range of pesticide residues that
may be present on a food. Similarly, the field trial conducted in New
Jersey was for a tolerance that is not involved in today's action.
EPA's regulations governing use of pesticides under experimental use
permits can be found at 40 CFR part 172. EPA also has regulations
governing the toxicological data testing laboratories that are designed
to insure data quality (40 CFR part 160). Federal jurisdiction
concerning the safety of workers in testing laboratories would be under
the Occupational Safety and Health Administration in the U.S.
Department of Labor. EPA has responded to similar comments from this
commenter on previous occasions. Refer to 70 FR 37686 (June 30, 2005),
70 FR 1354 (January 7, 2005), and 69 FR 63083 (October 29, 2004).
D. Revisions to Petitioned-For Tolerances
Based upon review of the data supporting the petition, EPA
determined that the proposed tolerances should be revised as follows:
Almond, hulls increased from 5.0 ppm to 6.0 ppm; barley, hay increased
from 6.0 ppm to 7.0 ppm; barley, straw increased from 1.4 ppm to 3.5
ppm; wheat, hay increased from 6.0 to 7.0 ppm; and wheat, straw
increased from 1.4 ppm to 1.5 ppm. EPA revised these tolerance levels
based on analysis of the residue field trial data using the Agency's
Tolerance Spreadsheet in accordance with the Agency's Guidance for
Setting Pesticide Tolerances Based on Field Trial Data Standard
Operating Procedure (SOP). Additionally, tolerances were not proposed,
but are required for barley, grain at 0.15 ppm based on detectable
residues using the Agency's Tolerance Spreadsheet and wheat, grain at
0.05 ppm, because tolerances are needed even with residues are non-
detectable. Also, a separate tolerance is not needed for pistachios, as
they are considered under the nut, tree, group 14.
V. Conclusion
Therefore, tolerances are established for residues of the fungicide
tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on food commodities
nut, tree, group 14 at 0.05 ppm; almond, hulls at 6.0 ppm; barley,
grain at 0.15 ppm; barley, hay at 7.0 ppm; barley, straw at 3.5 ppm;
wheat, forage at 3.0 ppm; wheat, grain at 0.05 ppm; wheat, hay at 7.0
ppm; and wheat, straw at 1.5 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 2, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
[[Page 27756]]
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.474 is amended in paragraph (a)(1) in the table by
alphabetically adding the commodities Almond, hulls and Nut, tree,
group 14 and by revising the following commodities to read as follows:
Sec. 180.474 Tebuconazole; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond, hulls........................................ 6.0
* * * * *
Barley, grain........................................ 0.15
Barley, hay.......................................... 7.0
Barley, straw........................................ 3.5
* * * * *
Nut, tree, group 14.................................. 0.05
* * * * *
Wheat, forage........................................ 3.0
Wheat, grain......................................... 0.05
Wheat, hay........................................... 7.0
Wheat, straw......................................... 1.5
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-10506 Filed 5-13-08; 8:45 am]
BILLING CODE 6560-50-S