Tebuconazole; Pesticide Tolerances, 47065-47072 [E8-18625]
Download as PDF
Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations
MRLs for tribenuron methyl on several
plant commodities. However, no
Canadian or Mexican MRLs for
tribenuron methyl have been proposed
or established for barley, hay; oat,
forage; oat, hay; wheat, forage; or wheat,
hay.
C. Response to Comments
A comment was received from a
private citizen supporting the Agency’s
updating of pesticide regulations.
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V. Conclusion
Therefore, tolerances are established
for residues of tribenuron methyl,
methyl-2-[[[[(4-methoxy-6-methyl-1,3,5triazin-2-yl)methylamino]
carbonyl]amino]sulfonyl]benzoate on
barley, hay at 0.4 ppm; oat, forage at
0.05 ppm; oat, hay at 0.05 ppm; wheat,
forage at 0.3 ppm; and wheat, hay at 0.5
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
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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: July 31, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
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47065
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.451 is amended by
alphabetically adding the following
entries to the table in paragraph (a) to
read as follows:
I
§ 180.451 Tribenuron Methyl; Tolerances
for Residues.
(a) * * *
Commodity
Parts per
million
*
*
*
*
Barley, hay ....................................
*
*
*
*
Oat, forage ....................................
*
*
*
*
Oat, hay ........................................
*
*
*
*
Wheat, forage ...............................
*
*
*
*
Wheat, hay ...................................
*
*
*
*
*
*
*
*
*
0.4
*
0.05
*
0.05
*
0.3
*
0.5
*
*
[FR Doc. E8–18189 Filed 8–12–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0097; FRL–8376–2]
Tebuconazole; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of tebuconazole
in or on apple, wet pomace; asparagus;
bean, succulent; bean, dry seed; beet,
garden, tops; beet, garden, roots;
brassica, leafy greens, subgroup 5B;
coffee, green bean; coffee, roasted bean;
corn, field, grain; corn, field, forage;
corn, field, stover; corn, pop, grain;
corn, pop, stover; corn, sweet, kernel
plus cob with husks removed; corn,
sweet, forage; corn, sweet, stover;
cotton, undelinted seed; cotton, gin
byproducts; Fruit, pome, group 11; fruit,
stone, group 12, except cherry; grain,
aspirated fractions; hop, dried cones;
lychee; mango, postharvest; okra; onion,
bulb, subgroup 3-07A; onion, green,
subgroup 3-07B; plum, pre- and postharvest; turnip, roots; turnip, tops;
soybean, forage; soybean, hay; soybean,
seed; sunflower, seed; sunflower, meal;
sunflower, refined oil; and vegetable,
cucurbit, group 9. Bayer CropScience LP
and Interregional Research Project No. 4
(IR4) have requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
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Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations
This regulation is effective
August 13, 2008. Objections and
requests for hearings must be received
on or before October 14, 2008, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0097. To access the
electronic docket, go to 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.
DATES:
SUPPLEMENTARY INFORMATION:
I. General Information
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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).
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15:55 Aug 12, 2008
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• 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
aspect of this regulation and may also
request a hearing on those objections.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2005–0097 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before October 14, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2005–0097, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
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• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of May 18,
2005 (70 FR 28527) (FRL–7708-5), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
pesticide petitions (PP) 6F4668, 0F6086,
0E6091, 0F6129, 1F6289, 4E6842, and
4F6854 by Bayer CropScience LP, P.O.
Box 12014, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709. The
petitions requested that 40 CFR 180.474
be amended by establishing tolerances
for residues of the fungicide
tebuconazole, alpha-[2-(4Chlorophenyl)ethyl]-alpha-(1,1dimethylethyl)-1H-1,2,4-triazole-1ethanol, in or on food commodities:
Fruit, pome, group 11 at 0.05 parts per
million (ppm) (PP 6F4668); bean,
succulent at 0.1 ppm (PP 0F6086); bean,
dry seed at 0.1 ppm (PP 0F6086); cotton,
undelinted seed at 2.0 ppm (PP 0F6086);
cotton, gin byproducts at 16 ppm (PP
0F6086); asparagus at 0.01 ppm (PP
0E6091); coffee, green bean, at 0.1 ppm
(PP 0E6091); coffee, roasted bean, at 0.2
ppm (PP 0E6091); garlic, dry bulb at 0.1
ppm (PP 0E6091); onion, dry bulb at 0.1
ppm (PP 0E6091); corn, field, grain at
0.01 ppm (PP 0F6129); corn, field,
forage at 3.0 ppm (PP 0F6129); corn,
field, stover at 3.0 ppm (PP 0F6129);
corn, pop, grain at 0.01 ppm (PP
0F6129); corn, pop, stover at 3.0 ppm
(PP 0F6129) corn, sweet, kernel plus cob
with husks removed at 0.5 ppm (PP
0F6129); corn, sweet, forage at 6.0 ppm
(PP 0F6129); corn, sweet, stover at 5.0
ppm (PP 0F6129); soybean, seed at 0.01
ppm (PP 0F6129); soybean, forage at
0.01 ppm (PP 0F6129); soybean, hay at
0.05 ppm (PP 0F6129); fruit, stone,
group 12, except cherry at 1.0 ppm (PP
1F6289); hop, dried cones at 30.0 ppm
(PP 4E6842); soybean, seed at 0.06 ppm
(PP 4F6854); soybean, forage at 17 ppm
(PP 4F6854); soybean, hay at 45 ppm
(PP 4F6854); soybean, hulls at 0.06 ppm
(PP 4F6854); and grain, aspirated
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fractions at 15 ppm (PP 4F6854). Bayer
CropScience also proposed to add a
postharvest use on cherries at the
current 0–day pre-harvest tolerance
level of 4.0 ppm. That notice referenced
a summary of the petitions prepared by
Bayer CropScience LP, the registrant,
which is available to the public in the
docket, https://www.regulations.gov.
Comments were received on the notice
of filing. EPA’s response to these
comments is discussed in Unit IV.C.
Note that the tolerances proposed for
the food commodities listed under PP
0E6091 were import tolerances.
Additionally, in the same Notice of
filing, EPA announced the filing of PPs
9E6045, 9E6046, 9E6048, 0E6103,
0E6117, 0E6153, 0E6158, and 0E6212
from Interregional Research Project No.
4 (IR4), 681 U.S. Highway #1 South,
North Brunswick, NJ 08902-3390. The
petitions requested that 40 CFR 180.474
be amended by establishing tolerances
for residues of the fungicide
tebuconazole, alpha-[2-(4Chlorophenyl)ethyl]-alpha-(1,1dimethylethyl)-1H-1,2,4-triazole-1ethanol, in or on food commodities:
Turnip, tops at 8.0 ppm (PP 9E6045);
turnip, roots at 0.4 ppm (PP 9E6045);
hops at 5.0 ppm (9E6046); vegetable,
cucurbit, group 9 at 0.1 ppm (PP
9E6048); mango, postharvest at 0.2 ppm
(PP 0E6103); fruit, stone, group 12,
except cherry at 1.0 ppm (PP 0E6117);
sunflower, seed at 0.05 ppm (PP
0E6153); sunflower, refined oil at 0.2
ppm (PP 0E6153); sunflower, meal at 0.2
ppm (PP 0E6153); okra at 1.0 ppm (PP
0E6158); and lychee at 1.5 ppm (PP
0E6212). That notice referenced a
summary of the petitions prepared by
the IR-4, which is available to the public
in the docket, https://
www.regulations.gov. Comments were
received on the notice of filing. EPA’s
response to these comments is
discussed in Unit IV.C.
In the Federal Register of April 12,
2006 (71 FR 18746) (FRL–7773–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of PPs
6E7036 by Interregional Research
Project No. 4 (IR4), 681 U.S. Highway 1
South, North Brunswick, NJ 089023390. 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 the food commodity
asparagus at 0.05 ppm. That notice
referenced a summary of the petition
prepared by IR-4, which is available to
the public in the docket, https://
www.regulations.gov. No comments
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were received in response to this Notice
of Filing.
In the Federal Register of June 27,
2007 (72 FR 35237) (FRL–8133–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of PP
6E7097 by Interregional Research
Project No. 4 (IR4), 681 U.S. Highway 1
South, North Brunswick, NJ 08902–
3390. The petition requested that 40
CFR 180.474 be amended by
establishing tolerances for residues of
the fungicide tebuconazole, alpha-[2-(4Chlorophenyl)ethyl]-alpha-(1,1dimethylethyl)-1H-1,2,4-triazole-1ethanol, in or on food commodities
vegetable, bulb, group 3 at 1.3 ppm;
Brassica, leafy greens, subgroup 5B at
2.5 ppm; beet, garden, roots at 0.7 ppm;
and beet, garden, leaves at 5.0 ppm.
That notice referenced a summary of the
petition prepared by IR-4, which is
available to the public in the docket,
https://www.regulations.gov. No
comments were received in response to
this Notice of Filing.
Based upon review of the data
supporting the petitions, EPA has
modified the level and/or the tolerance
expression for all commodities except
the following: Pome fruit; bean
succulent, cotton, undelinted seed;
corn, sweet kernel plus cob with husks
removed; sunflower, seed; sunflower,
meal; sunflower, oil; brassica, leafy
greens subgroup 5B; and beet, garden
root. The reason for these changes is
explained in Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue....’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
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47067
section 408(b)(2)(D) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerances for residues of tebuconazole.
A. Toxicological Profile
The toxicological profile for
tebuconazole can be found in the final
rule published in the Federal Register
of May 14, 2008 (73 FR 27748-27756,
FRL–8364–6). Refer to this Federal
Register document, available at https://
www.regulations.gov for a detailed
discussion of the toxicological profile of
tebuconazole.
B. Toxicological Endpoints
The toxicological endpoints for
tebuconazole can be found in the final
rule published in the Federal Register
of May 14, 2008 (73 FR 27748–27756,
FRL–8364–6). Refer to this Federal
Register document, available at https://
www.regulations.gov, for a detailed
discussion of the toxicological endpoint
selection for tebuconazole.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to tebuconazole, EPA
considered exposure under the
petitioned-for tolerances, including
other pending petitions, as well as all
existing tebuconazole tolerances in (40
CFR 180.474). EPA assessed dietary
exposures from tebuconazole in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1–day or single
exposure.
In estimating acute dietary exposure,
EPA used food consumption
information from the United States
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels
in food, anticipated residues for
bananas, grapes, raisins, nectarines,
peaches and peanut butter were derived
using the latest USDA Pesticide Data
Program (PDP) monitoring data from
2002–2006. Anticipated residues for all
other registered and proposed food
commodities were based on field trial
data. Projected percent crop treated
estimates were used for apples, apricots,
cherries, hops, plums and sweet corn.
For the remaining crops, 100% crop
treated was assumed. Available
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processing data were used to refine
anticipated residues for apples/pears
(dried and juice), apricots (dried),
cherry (juice), coffee (roasted bean),
grapes (juice), plums (prunes/prune
juice) and peanut (oil). For all other
processed commodities, DEEM (ver.
7.81) default processing factors were
assumed.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the same assumptions as
stated above for acute exposure (Unit
III.C.1.i).
iii. Cancer. As explained in the
Federal Register of May 14, 2008 (73 FR
27748–27756, FRL–8364–6), the chronic
risk assessment is considered to be
protective of any cancer effects;
therefore, a separate quantitative cancer
dietary risk assessment was not
conducted.
iv. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of FFDCA authorizes EPA
to use available data and information on
the anticipated residue levels of
pesticide residues in food and the actual
levels of pesticide residues that have
been measured in food. If EPA relies on
such information, EPA must require
pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. For the present action, EPA
will issue such data call-ins as are
required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section
408(f)(1). Data will be required to be
submitted no later than 5 years from the
date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area, the exposure estimate
does not understate exposure for the
population in such area.
In addition, the Agency must provide
for periodic evaluation of any estimates
used. To provide for the periodic
evaluation of the estimate of PCT as
required by FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
The Agency assumed PCT for grapes;
grape, raisins; nectarines; oats; peaches;
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and peanuts. The PCT for each crop is
as follows: Grapes: 25%; grape, raisin:
25%; nectarine: 25%; oats: 2.5%; peach:
20%; and peanuts: 45%.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6 years. EPA uses an average PCT
for chronic dietary risk analysis. The
average PCT figure for each existing use
is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
nearest 5%, except for those situations
in which the average PCT is less than 1.
In those cases, 1% is used as the average
PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for
acute dietary risk analysis. The
maximum PCT figure is the highest
observed maximum value reported
within the recent 6 years of available
public and private market survey data
for the existing use and rounded up to
the nearest multiple of 5%.
The Agency used projected percent
crop treated (PPCT) information for
tebuconazole on apple (44% acute
assessment, 41% chronic assessment);
apricot (56% acute assessment, 43%
chronic assessment); cherry (preharvest: 42% acute assessment, 37%
chronic assessment); cherry (postharvest: 100% acute assessment, 66%
chronic assessment); corn, sweet (22%
acute assessment, 14% chronic
assessment); hop (64% acute
assessment, 64% chronic assessment);
plum, pre- and post-harvest (26% acute
assessment, 24% chronic assessment);
and turnip tops (68% acute assessment,
44% chronic assessment).
EPA estimates PPCT for a new
pesticide use by assuming that its actual
PCT during the initial 5 years of use on
a specific use site will not exceed the
recent PCT of the market leader (i.e., the
one with the greatest PCT) on that site.
An average market leader PCT, based on
three recent surveys of pesticide usage,
if available, is used for chronic risk
assessment, while the maximum PCT
from the same three recent surveys, if
available, is used for acute risk
assessment. The average and maximum
market leader PCTs may each be based
on one or two surveys if three are not
available. Comparisons are only made
among pesticides of the same pesticide
types (i.e., the leading fungicide on the
use site is selected for comparison with
the new fungicide). The market leader
PCTs used to determine the average and
the maximum may be each for the same
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pesticide or for different pesticides
since the same or different pesticides
may dominate for each year. Typically,
EPA uses USDA/NASS as the source for
raw PCT data because it is publicly
available. When a specific use site is not
surveyed by USDA/NASS, EPA uses
other sources including proprietary
data.
An estimated PPCT, based on the
average PCT of the market leaders, is
appropriate for use in chronic dietary
risk assessment, and an estimated PPCT,
based on the maximum PCT of the
market leaders, is appropriate for use in
acute dietary risk assessment. This
method of estimating PPCTs for a new
use of a registered pesticide or a new
pesticide produces high-end estimates
that are unlikely, in most cases, to be
exceeded during the initial 5 years of
actual use. Predominant factors that
bear on whether the PPCTs could be
exceeded may include PCTs of similar
chemistries, pests controlled by
alternatives, pest prevalence in the
market and other factors. All relevant
information currently available for
predominant factors have been
considered for tebuconazole on the
seven crops, resulting in adjustments to
the initial estimates for three crops to
account for lack of confidence in
projections based on less than three
observations, old data and/or data based
on expert opinion.
The Agency believes that the three
conditions discussed in Unit III.C.1.iv.
have been met. With respect to
Condition a, PCT estimates are derived
from Federal and private market survey
data, which are reliable and have a valid
basis, or conservative estimates based
on information from agricultural
experts. The Agency is reasonably
certain that the percentage of the food
treated is not likely to be an
underestimation. As to Conditions b and
c, regional consumption information
and consumption information for
significant subpopulations is taken into
account through EPA’s computer-based
model for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available reliable information on
the regional consumption of food to
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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
post application exposures to adults
during golfing and children playing on
treated wood structures are also
possible. Children may also be exposed
via the incidental oral route when
playing on treated wood structures.
Long-term exposure is not expected. As
a result, risk assessments have been
completed for residential handler
scenarios as well as residential post
application scenarios.
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4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Tebuconazole is a member of the
triazole-containing class of pesticides.
Triazole-derived pesticides can form the
common metabolite 1,2,4-triazole and
two triazole conjugates (triazole alanine
and triazole acetic acid). Refer to EPA’s
recent tolerance rulemaking on
tebuconazole in the Federal Register of
May 14, 2008 (73 FR 27748-27756, FRL–
8364–6), for more information on this
risk assessment.
D. Safety Factor for Infants and
Children
In the Federal Register of May 14,
2008 (73 FR 27748–27756, FRL–8364–6)
the Agency published a Final rule
establishing tolerances for residues of
tebuconazole in or on various food
commodities. When the Agency
conducted the risk assessments in
support of that tolerance action, it also
assessed dietary exposure to
tebuconazole assuming that all of the
tolerances in this action were in place.
Accordingly, EPA relies on the decision
on the FQPA safety factor for infants
and children as set out in that action.
Refer to EPA’s recent tolerance
rulemaking on tebuconazole, available
at https://www.regulations.gov, for a
detailed discussion and selection of a
safety factor for infants and children for
tebuconazole. For the reasons explained
there, EPA reduced the FQPA safety
factor to 3X for all potential exposure
scenarios.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the acute population adjusted dose
(aPAD) and chronic population adjusted
dose (cPAD). The aPAD and cPAD
represent the highest safe exposures,
taking into account all appropriate
safety factors (SFs). EPA calculates the
aPAD and cPAD by dividing the point
of departure (POD) by all applicable
uncertainty factors (UFs). For linear
cancer risks, EPA calculates the
probability of additional cancer cases
given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term
risks are evaluated by comparing the
estimated aggregate food, water, and
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residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
Below, EPA has summarized the
conclusions from its recent tolerance
rulemaking on tebuconazole which took
into account exposure to tebuconazole
from the food commodities covered by
the tolerances in this action. Refer to
EPA’s recent tolerance rulemaking on
tebuconazole, available at https://
www.regulations.gov, for a detailed
discussion of EPA’s safety
determinations.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
tebuconazole will occupy 53% of the
aPAD for the population group (all
infants less than 1 year old) receiving
the greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to tebuconazole from food
and water will utilize 4% of the cPAD
for the U.S. population and 11% of the
cPAD for the most highly exposed
population group (infants less than 1
year old).
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Tebuconazole is
currently registered for uses that could
result in short-term residential exposure
and the Agency has determined that it
is appropriate to aggregate chronic
exposure through food and water with
short-term residential exposures to
tebuconazole.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded that the
short-term aggregate MOE from dietary
exposure (food + drinking water) and
non-occupational/residential handler
exposure for adults using a hose-end
sprayer on ornamentals is 400. The
short-term aggregate MOE from dietary
exposure and exposure from golfing is
1,800. The short-term aggregate MOE to
children from dietary exposure and
exposure from wood surfaces treated at
the above ground use rate is 530. The
short-term aggregate MOE to children
from dietary exposure and exposure to
wood surfaces treated at the below
ground use rate is 230. The combined
and aggregate MOEs for wood treated for
below ground uses exceed the Agency’s
LOC of 300, and indicate a potential risk
of concern. However, the MOE of 230 is
based on unrealistic assumptions and
EPA has concluded that aggregate
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exposure does not pose a risk of
concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Tebuconazole is currently registered for
uses that could result in 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. Although tebuconazole is
classified as a Group C CarcinogenPossible Human Carcinogen, the Agency
has concluded that the chronic RfD is
protective of the cancer effects.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population or to infants and children
from aggregate exposure to tebuconazole
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate gas chromatography/
nitrogen phosphorus detection and
liquid chromatography/mass
spectrometry/mass spectrometry (GC/
NPD and LC/MS/MS) methods are
available for enforcing tolerances for
tebuconazole and its metabolites in
plant commodities, livestock matrices
and processing studies. The methods
have been adequately validated by an
independent laboratory in conjunction
with a previous petition. The method
may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
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B. International Residue Limits
There are currently Codex, Canadian
and Mexican maximum residue limits
(MRLs) for residues of tebuconazole in
or on a variety of plant and livestock
commodities. The tolerance definition
for residues in plants is tebuconazole,
per se, for Codex, Canada, and Mexico.
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For livestock commodities, the tolerance
expression is for the combined residues
of tebuconazole and HWG 2061 in the
United States and Canada, and
tebuconazole, per se, for Codex. Where
possible, the proposed tolerance levels
have been harmonized with the MRLs
from Canada, Mexico, and Codex. With
regard to the pome fruit tolerance, the
Agency recommended tolerance of 0.05
ppm differs from the Codex MRL of 0.5
mg/kg. Harmonization of the pome fruit
tolerances is not possible because U.S.
data were derived using long preharvest intervals (PHIs) of 75-129 days
while Italian data were derived using
maximum PHIs of 14 days. With regard
to the cucurbit vegetable tolerance, the
Agency recommended tolerance of 0.09
ppm for vegetable, cucurbit, group 9,
differs from the Codex MRL of 0.2 mg/
kg on cucumber and 0.02 mg/kg on
summer squash. The Agency notes that
some of the cucumber data from Spain
were derived from trials conducted in
greenhouses. Although the application
rate used for the Spanish trials was
similar to the trials conducted in the
United States, it is quite normal for
greenhouse trials to give higher
residues. If the greenhouse trials are
ignored, then the remaining Codex data
are in the 0.02 – 0.04 range, consistent
with the U.S. data and tolerance. In
short, the higher Codex MRL for
cucumber accommodates the
greenhouse use.
C. Response to Comments
The Agency received a comment from
a citizen of New Jersey. The commenter
questioned the necessity of using
taxpayer money through the agency of
the Interregional Research Project No. 4
to develop pesticides, challenged the
appropriateness of conducting some of
the tebuconazole field trials outside of
the United States, expressed concern
over whether specific warnings were
given to residents of New Jersey prior to
conducting field trials in that State, and
worried that students at Rutgers
University may have been injured in the
tebuconazole toxicological tests on
animals that were performed at that
facility.
In response, as to the commenter’s
concern with field trials that were
conducted in countries other than the
United States, EPA notes that frequently
field trials are conducted in other
countries as well as in the United States
so that EPA can understand the range of
pesticide residues that may be present
on a food. EPA received several
applications for tebuconazole import
tolerances and it is appropriate that the
field trials would be conducted in the
countries where the pesticide was to be
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used. Additionally, some tebuconazole
import tolerances were proposed with
foreign data, and then a U.S. use was
proposed and U.S. data submitted. None
of the other comments address the
findings made in this action regarding
the establishment of a tolerance.
Nonetheless, EPA provides the
following information regarding the
comments. IR-4 was established by the
USDA to help minor acreage; specialty
crop producers obtain EPA tolerances
and new registered uses of pesticides.
As to whether warnings were given to
residents of New Jersey regarding field
trials, EPA would point out that
experimental field trials are subject to
EPA regulations at 40 CFR part 172.
EPA also has regulations governing the
toxicological data testing laboratories
that are designed to insure data quality
(40 CFR part 160). Federal jurisdiction
concerning the safety of workers in
testing laboratories would be under the
Occupational Safety and Health
Administration in the U.S. Department
of Labor. EPA has responded to similar
comments from this commenter on
previous occasions. Refer to 70 FR
37686 (June 30, 2005), 70 FR 1354
(January 7, 2005), and 69 FR 63083
(October 29, 2004).
D. Revisions to Petitioned-for
Tolerances
Based upon review of the data
supporting the petitions, EPA
determined that the proposed tolerances
should be revised as follows: Cotton, gin
byproducts at 25.0 ppm; asparagus at
0.05 ppm; coffee, green bean at 0.15
ppm; coffee, roasted bean, at 0.3 ppm;
onion, bulb, subgroup 3-07A at 0.2 ppm;
corn, field, grain at 0.05 ppm; corn,
field, forage at 4.0 ppm; corn, field,
stover at 3.5 ppm; corn, pop, grain at
0.05 ppm; corn, pop, stover at 3.5 ppm;
corn, sweet, forage at 7.0 ppm; corn,
sweet, stover at 6.0 ppm; turnip, tops
(limited to east of the Rockies) at 7.0
ppm; turnip, roots at 0.5 ppm; beet,
garden, tops at 7.0 ppm; beet, garden,
root at 0.70; hop, dried cones at 35.0
ppm; vegetable, cucurbit, group 9 at
0.09 ppm; mango, postharvest at 0.15
ppm; plum, pre- and post-harvest at 1.0
ppm; okra at 1.2 ppm; lychee at 1.6
ppm; soybean, seed at 0.08 ppm;
soybean, forage at 25 ppm; soybean, hay
at 50 ppm; and grain, aspirated fractions
16.0 ppm. A separate tolerance is
required for apple, wet pomace at 0.1
ppm. No tolerance is required for
soybean hulls. A tolerance of 1.3 ppm
is required for onion, green, subgroup 307B. The tolerance proposed by IR-4 for
hops (PP 9E6046) is covered by the
registrant proposed tolerance for hops,
dried cones (PP 4E6842). EPA revised
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most of these tolerance levels based on
analysis of the residue field trial data
using the Agency’s Tolerance
Spreadsheet in accordance with the
Agency’s Guidance for Setting Pesticide
Tolerances Based on Field Trial Data
Standard Operating Procedure (SOP).
For the proposed tolerances on
asparagus; corn, field, grain; and by
translation corn, pop grain the tolerance
could not be set lower than the limit of
quantitation (LOQ) of the enforcement
analytical method, which was 0.05 ppm
for tebuconazole. For corn, field, forage,
the proposed tolerance was raised to 4.0
ppm based on the maximum residue
level in the field trials.
Additionally, IR-4 petitioned for a
tolerance on bulb vegetables group 3 as
that crop group was defined at the time
of the petition (6E7097). In the Federal
Register of December 7, 2007 (72 FR
69150–69158) (FRL–8340–6), EPA
issued a final rule that revised the crop
grouping regulations. EPA indicated in
the December 7, 2007 final rule as well
as the earlier May 23, 2007 proposed
rule (72 FR 28920–28930) that, for
existing petitions for which a Notice of
Filing had been published, the Agency
would attempt to conform these
petitions to the rule. As part of this
action, EPA expanded and revised bulb
vegetables group 3. Changes to crop
group 3 (bulb vegetables) included
adding new commodities, creating
subgroups for bulb and green onions,
and changing the name of one of the
representative commodities from
‘‘onion, dry bulb’’ to ‘‘onion, bulb’’. The
Bayer proposed tolerance for garlic
(bulb) and onion (bulb) with no U. S.
registration was superseded by the
proposed tolerance for bulb vegetables.
The proposed tolerance on bulb
vegetables group 3 was determined to be
inappropriate because the residues were
found to be more than a factor of 5x.
Thus, separate tolerances were set for
the crop subgroups, onion, bulb,
subgroup 3-07A at 0.2 ppm, and onion,
green, subgroup 3-07B at 1.3 ppm.
EPA concludes it is reasonable to
revise the petitioned-for tolerance so
that they agree with the recent crop
grouping revisions because (1) although
the new crop groups/subgroups include
several new commodities, the added
commodities are closely related minor
crops which contribute little to overall
dietary or aggregate exposure and risk;
and tebuconazole exposure from these
added commodities was considered
when EPA conducted the dietary and
aggregate risk assessments supporting
this action; and (2) the representative
commodities for the revised crop
groups/subgroups have not changed.
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Finally, the proposed tolerance for
hops, domestically grown, in PP
4E6046, was superseded by the
proposed tolerance for hops, dry cone
(based on data for imported hops) in PP
4E6842, since the latter proposed
tolerance is higher, 30.0 ppm. The
proposed tolerance for asparagus
(domestic) at 0.2 ppm, in PP 6E7036,
superseded the proposed tolerance for
imported asparagus at 0.1 ppm, in PP
0E6091. The tolerances for inadvertent
residues of tebuconazole in soybeans
planted in rotation with treated wheat
in PP 0F6129, were superseded by the
proposed tolerance for soybean
following a direct treatment of
tebuconazole in PP 4F6854.
V. Conclusion
Therefore, tolerances are established
for residues of the fungicide
tebuconazole, alpha-[2-(4Chlorophenyl)ethyl]-alpha-(1,1dimethylethyl)-1H-1,2,4-triazole-1ethanol, in or on food commodities
apple, wet pomace at 0.1 ppm;
asparagus at 0.05 ppm; bean, succulent
at 0.1 ppm; bean, dry seed at 0.1 ppm;
beet, garden, tops at 7.0 ppm; beet,
garden, roots at 0.70 ppm; brassica, leafy
greens, subgroup 5B at 2.5 ppm; coffee,
green bean at 0.15 ppm; coffee, roasted
bean at 0.3 ppm; corn, field, grain at
0.05 ppm; corn, field, forage at 4.0 ppm;
corn, field, stover at 3.5 ppm; corn, pop,
grain at 0.05 ppm; corn, pop, stover at
3.5 ppm; corn, sweet, kernel plus cob
with husks removed at 0.5 ppm; corn,
sweet, forage at 7.0 ppm; corn, sweet,
stover at 6.0 ppm; cotton, undelinted
seed at 2.0 ppm; cotton, gin byproducts
at 25.0 ppm; Fruit, pome, group 11 at
0.05 ppm; fruit, stone, group 12, except
cherry at 1.0 ppm; grain, aspirated
fractions at 16.0 ppm; hop, dried cones
at 35.0 ppm; lychee at 1.6 ppm; mango,
postharvest at 0.15 ppm; okra at 1.2
ppm; onion, bulb, subgroup 3-07A at 0.2
ppm; onion, green, subgroup 3-07B at
1.3 ppm; plum, pre- and post-harvest at
1.0 ppm; soybean, forage at 25 ppm;
soybean, hay at 50 ppm; soybean, seed
at 0.08 ppm; sunflower, seed at 0.05
ppm; sunflower, meal at 0.2 ppm;
sunflower, refined oil at 0.2 ppm;
vegetable, cucurbit, group 9 at 0.09
ppm; turnip, roots at 0.5 ppm; and
turnip, tops at 7.0 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petitions submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
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47071
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).
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VII. Congressional Review Act
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: July 29, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
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 by
revising the introductory text of
paragraph (a)(1), by alphabetically
adding the following commodities to the
table in paragraph (a)(1); by removing
the text from paragraph (b) and
reserving the paragraph designation and
heading; and by adding a new paragraph
(c).
I
§ 180.474 Tebuconazole; tolerances for
residues.
(a) General. (1) Tolerances are
established for the residues of the
fungicide, tebuconazole, alpha-[2-(4Chlorophenyl)ethyl]-alpha-(1,1dimethylethyl)-1H-1,2,4-triazole-1ethanol in or on the following
commodities:
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*
*
*
*
Apple, wet pomace .......................
Asparagus .....................................
*
*
*
*
Bean, succulent ............................
Bean, dry seed .............................
Beet, garden, roots .......................
Beet, garden, tops ........................
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Brassica, leafy greens, subgroup
5B ..............................................
Coffee, green bean1 .....................
Coffee, roasted bean1 ..................
Corn, field, grain ...........................
Corn, field, forage .........................
Corn, field, stover .........................
Corn, pop, grain ............................
Corn, pop, stover ..........................
Corn, sweet, kernel plus cob with
husks removed ..........................
Corn, sweet, forage ......................
Corn, sweet, stover ......................
Cotton, undelinted seed ...............
Cotton, gin byproducts .................
Fruit, pome, group 11 ...................
Fruit, stone, group 12, except
cherry ........................................
Grain, aspirated fractions .............
*
*
*
*
Hop, dried cones ..........................
Lychee ..........................................
Mango, postharvest ......................
*
*
*
*
Okra ..............................................
Onion, bulb, subgroup 3-07A .......
Onion, green, subgroup 3-07B .....
*
*
*
*
Plum, pre- and post-harvest .........
*
*
*
*
Soybean, forage ...........................
Soybean, hay ................................
Soybean, seed ..............................
Sunflower, seed ............................
Sunflower, meal ............................
Sunflower, refined oil ....................
Vegetable, cucurbit, group 9 ........
*
*
*
*
1There
Jkt 214001
35.0
1.6
0.15
*
1.2
0.2
1.3
*
1.0
*
25
50
0.08
0.05
0.2
0.2
0.09
*
Parts per
million
*
*
16.0
*
*
*
*
*
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. Tolerances with regional
registrations for the residues of the
fungicide, tebuconazole, alpha-[2-(4Chlorophenyl)ethyl]-alpha-(1,1dimethylethyl)-1H-1,2,4-triazole-1ethanol in or on the following
commodities:
*
*
*
*
0.5
7.0
*
[FR Doc. E8–18625 Filed 8–12–08; 8:45 am]
BILLING CODE 6560–50–S
0.1
0.1
0.70
7.0
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
40 CFR Part 180
[EPA–HQ–OPP–2007–0564; FRL–8374–4]
Thifensulfuron Methyl; Pesticide
Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of thifensulfuron
methyl in or on barley, hay; oat, forage;
oat, hay; wheat, forage, and wheat, hay.
E.I. DuPont de Nemours and Company
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
1.0 (FFDCA).
*
Turnip, roots .................................
Turnip, tops ...................................
ENVIRONMENTAL PROTECTION
AGENCY
0.5
7.0
6.0
2.0
25.0
0.05
are no U.S. registrations as of 7/31/
Commodity
0.1
0.05
2.5
0.15
0.3
0.05
4.0
3.5
0.05
3.5
2008.
Parts per
million
Commodity
VerDate Aug<31>2005
Parts per
million
Commodity
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).
This regulation is effective
August 13, 2008. Objections and
requests for hearings must be received
on or before October 14, 2008, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION ).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0564. To access the
electronic docket, go to https://
www.regulations.gov, and search for the
docket ID number. 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:
Vickie Walters, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
DATES:
E:\FR\FM\13AUR1.SGM
13AUR1
Agencies
[Federal Register Volume 73, Number 157 (Wednesday, August 13, 2008)]
[Rules and Regulations]
[Pages 47065-47072]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18625]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0097; FRL-8376-2]
Tebuconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
tebuconazole in or on apple, wet pomace; asparagus; bean, succulent;
bean, dry seed; beet, garden, tops; beet, garden, roots; brassica,
leafy greens, subgroup 5B; coffee, green bean; coffee, roasted bean;
corn, field, grain; corn, field, forage; corn, field, stover; corn,
pop, grain; corn, pop, stover; corn, sweet, kernel plus cob with husks
removed; corn, sweet, forage; corn, sweet, stover; cotton, undelinted
seed; cotton, gin byproducts; Fruit, pome, group 11; fruit, stone,
group 12, except cherry; grain, aspirated fractions; hop, dried cones;
lychee; mango, postharvest; okra; onion, bulb, subgroup 3-07A; onion,
green, subgroup 3-07B; plum, pre- and post-harvest; turnip, roots;
turnip, tops; soybean, forage; soybean, hay; soybean, seed; sunflower,
seed; sunflower, meal; sunflower, refined oil; and vegetable, cucurbit,
group 9. Bayer CropScience LP and Interregional Research Project No. 4
(IR4) have requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
[[Page 47066]]
DATES: This regulation is effective August 13, 2008. Objections and
requests for hearings must be received on or before October 14, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0097. To access the
electronic docket, go to 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 aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2005-0097 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before October 14, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2005-0097, by one of the following methods:
Federal eRulemaking Portal: 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 28527) (FRL-7708-5),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of pesticide petitions (PP) 6F4668,
0F6086, 0E6091, 0F6129, 1F6289, 4E6842, and 4F6854 by Bayer CropScience
LP, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC
27709. The petitions requested that 40 CFR 180.474 be amended by
establishing tolerances for residues of the fungicide tebuconazole,
alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-
triazole-1-ethanol, in or on food commodities: Fruit, pome, group 11 at
0.05 parts per million (ppm) (PP 6F4668); bean, succulent at 0.1 ppm
(PP 0F6086); bean, dry seed at 0.1 ppm (PP 0F6086); cotton, undelinted
seed at 2.0 ppm (PP 0F6086); cotton, gin byproducts at 16 ppm (PP
0F6086); asparagus at 0.01 ppm (PP 0E6091); coffee, green bean, at 0.1
ppm (PP 0E6091); coffee, roasted bean, at 0.2 ppm (PP 0E6091); garlic,
dry bulb at 0.1 ppm (PP 0E6091); onion, dry bulb at 0.1 ppm (PP
0E6091); corn, field, grain at 0.01 ppm (PP 0F6129); corn, field,
forage at 3.0 ppm (PP 0F6129); corn, field, stover at 3.0 ppm (PP
0F6129); corn, pop, grain at 0.01 ppm (PP 0F6129); corn, pop, stover at
3.0 ppm (PP 0F6129) corn, sweet, kernel plus cob with husks removed at
0.5 ppm (PP 0F6129); corn, sweet, forage at 6.0 ppm (PP 0F6129); corn,
sweet, stover at 5.0 ppm (PP 0F6129); soybean, seed at 0.01 ppm (PP
0F6129); soybean, forage at 0.01 ppm (PP 0F6129); soybean, hay at 0.05
ppm (PP 0F6129); fruit, stone, group 12, except cherry at 1.0 ppm (PP
1F6289); hop, dried cones at 30.0 ppm (PP 4E6842); soybean, seed at
0.06 ppm (PP 4F6854); soybean, forage at 17 ppm (PP 4F6854); soybean,
hay at 45 ppm (PP 4F6854); soybean, hulls at 0.06 ppm (PP 4F6854); and
grain, aspirated
[[Page 47067]]
fractions at 15 ppm (PP 4F6854). Bayer CropScience also proposed to add
a postharvest use on cherries at the current 0-day pre-harvest
tolerance level of 4.0 ppm. That notice referenced a summary of the
petitions prepared by Bayer CropScience LP, the registrant, which is
available to the public in the docket, https://www.regulations.gov.
Comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit IV.C. Note that the tolerances proposed
for the food commodities listed under PP 0E6091 were import tolerances.
Additionally, in the same Notice of filing, EPA announced the
filing of PPs 9E6045, 9E6046, 9E6048, 0E6103, 0E6117, 0E6153, 0E6158,
and 0E6212 from Interregional Research Project No. 4 (IR4), 681 U.S.
Highway 1 South, North Brunswick, NJ 08902-3390. The petitions
requested that 40 CFR 180.474 be amended by establishing tolerances for
residues of the fungicide tebuconazole, alpha-[2-(4-
Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-
ethanol, in or on food commodities: Turnip, tops at 8.0 ppm (PP
9E6045); turnip, roots at 0.4 ppm (PP 9E6045); hops at 5.0 ppm
(9E6046); vegetable, cucurbit, group 9 at 0.1 ppm (PP 9E6048); mango,
postharvest at 0.2 ppm (PP 0E6103); fruit, stone, group 12, except
cherry at 1.0 ppm (PP 0E6117); sunflower, seed at 0.05 ppm (PP 0E6153);
sunflower, refined oil at 0.2 ppm (PP 0E6153); sunflower, meal at 0.2
ppm (PP 0E6153); okra at 1.0 ppm (PP 0E6158); and lychee at 1.5 ppm (PP
0E6212). That notice referenced a summary of the petitions prepared by
the IR-4, which is available to the public in the docket, https://
www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
In the Federal Register of April 12, 2006 (71 FR 18746) (FRL-7773-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of PPs 6E7036 by Interregional
Research Project No. 4 (IR4), 681 U.S. Highway 1 South, North
Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.474 be
amended by establishing tolerances for residues of the fungicide
tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on the food commodity
asparagus at 0.05 ppm. That notice referenced a summary of the petition
prepared by IR-4, which is available to the public in the docket,
https://www.regulations.gov. No comments were received in response to
this Notice of Filing.
In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of PP 6E7097 by Interregional
Research Project No. 4 (IR4), 681 U.S. Highway 1 South, North
Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.474 be
amended by establishing tolerances for residues of the fungicide
tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on food commodities
vegetable, bulb, group 3 at 1.3 ppm; Brassica, leafy greens, subgroup
5B at 2.5 ppm; beet, garden, roots at 0.7 ppm; and beet, garden, leaves
at 5.0 ppm. That notice referenced a summary of the petition prepared
by IR-4, which is available to the public in the docket, https://
www.regulations.gov. No comments were received in response to this
Notice of Filing.
Based upon review of the data supporting the petitions, EPA has
modified the level and/or the tolerance expression for all commodities
except the following: Pome fruit; bean succulent, cotton, undelinted
seed; corn, sweet kernel plus cob with husks removed; sunflower, seed;
sunflower, meal; sunflower, oil; brassica, leafy greens subgroup 5B;
and beet, garden root. The reason for these changes is explained in
Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of tebuconazole.
A. Toxicological Profile
The toxicological profile for tebuconazole can be found in the
final rule published in the Federal Register of May 14, 2008 (73 FR
27748-27756, FRL-8364-6). Refer to this Federal Register document,
available at https://www.regulations.gov for a detailed discussion of
the toxicological profile of tebuconazole.
B. Toxicological Endpoints
The toxicological endpoints for tebuconazole can be found in the
final rule published in the Federal Register of May 14, 2008 (73 FR
27748-27756, FRL-8364-6). Refer to this Federal Register document,
available at https://www.regulations.gov, for a detailed discussion of
the toxicological endpoint selection for tebuconazole.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tebuconazole, EPA considered exposure under the petitioned-
for tolerances, including other pending petitions, as well as all
existing tebuconazole tolerances in (40 CFR 180.474). EPA assessed
dietary exposures from tebuconazole in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, anticipated residues
for bananas, grapes, raisins, nectarines, peaches and peanut butter
were derived using the latest USDA Pesticide Data Program (PDP)
monitoring data from 2002-2006. Anticipated residues for all other
registered and proposed food commodities were based on field trial
data. Projected percent crop treated estimates were used for apples,
apricots, cherries, hops, plums and sweet corn. For the remaining
crops, 100% crop treated was assumed. Available
[[Page 47068]]
processing data were used to refine anticipated residues for apples/
pears (dried and juice), apricots (dried), cherry (juice), coffee
(roasted bean), grapes (juice), plums (prunes/prune juice) and peanut
(oil). For all other processed commodities, DEEM (ver. 7.81) default
processing factors were assumed.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the same assumptions as stated above for acute
exposure (Unit III.C.1.i).
iii. Cancer. As explained in the Federal Register of May 14, 2008
(73 FR 27748-27756, FRL-8364-6), the chronic risk assessment is
considered to be protective of any cancer effects; therefore, a
separate quantitative cancer dietary risk assessment was not conducted.
iv. Anticipated residue and percent crop treated (PCT)
information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use
available data and information on the anticipated residue levels of
pesticide residues in food and the actual levels of pesticide residues
that have been measured in food. If EPA relies on such information, EPA
must require pursuant to FFDCA section 408(f)(1) that data be provided
5 years after the tolerance is established, modified, or left in
effect, demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency assumed PCT for grapes; grape, raisins; nectarines;
oats; peaches; and peanuts. The PCT for each crop is as follows:
Grapes: 25%; grape, raisin: 25%; nectarine: 25%; oats: 2.5%; peach:
20%; and peanuts: 45%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than 1. In those cases, 1%
is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
The Agency used projected percent crop treated (PPCT) information
for tebuconazole on apple (44% acute assessment, 41% chronic
assessment); apricot (56% acute assessment, 43% chronic assessment);
cherry (pre-harvest: 42% acute assessment, 37% chronic assessment);
cherry (post-harvest: 100% acute assessment, 66% chronic assessment);
corn, sweet (22% acute assessment, 14% chronic assessment); hop (64%
acute assessment, 64% chronic assessment); plum, pre- and post-harvest
(26% acute assessment, 24% chronic assessment); and turnip tops (68%
acute assessment, 44% chronic assessment).
EPA estimates PPCT for a new pesticide use by assuming that its
actual PCT during the initial 5 years of use on a specific use site
will not exceed the recent PCT of the market leader (i.e., the one with
the greatest PCT) on that site. An average market leader PCT, based on
three recent surveys of pesticide usage, if available, is used for
chronic risk assessment, while the maximum PCT from the same three
recent surveys, if available, is used for acute risk assessment. The
average and maximum market leader PCTs may each be based on one or two
surveys if three are not available. Comparisons are only made among
pesticides of the same pesticide types (i.e., the leading fungicide on
the use site is selected for comparison with the new fungicide). The
market leader PCTs used to determine the average and the maximum may be
each for the same pesticide or for different pesticides since the same
or different pesticides may dominate for each year. Typically, EPA uses
USDA/NASS as the source for raw PCT data because it is publicly
available. When a specific use site is not surveyed by USDA/NASS, EPA
uses other sources including proprietary data.
An estimated PPCT, based on the average PCT of the market leaders,
is appropriate for use in chronic dietary risk assessment, and an
estimated PPCT, based on the maximum PCT of the market leaders, is
appropriate for use in acute dietary risk assessment. This method of
estimating PPCTs for a new use of a registered pesticide or a new
pesticide produces high-end estimates that are unlikely, in most cases,
to be exceeded during the initial 5 years of actual use. Predominant
factors that bear on whether the PPCTs could be exceeded may include
PCTs of similar chemistries, pests controlled by alternatives, pest
prevalence in the market and other factors. All relevant information
currently available for predominant factors have been considered for
tebuconazole on the seven crops, resulting in adjustments to the
initial estimates for three crops to account for lack of confidence in
projections based on less than three observations, old data and/or data
based on expert opinion.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis, or conservative estimates based on
information from agricultural experts. The Agency is reasonably certain
that the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to
[[Page 47069]]
which tebuconazole may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for tebuconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of tebuconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at 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 post application exposures to adults during
golfing and children playing on treated wood structures are also
possible. Children may also be exposed via the incidental oral route
when playing on treated wood structures. Long-term exposure is not
expected. As a result, risk assessments have been completed for
residential handler scenarios as well as residential post application
scenarios.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Tebuconazole is a member of the triazole-containing class of
pesticides. Triazole-derived pesticides can form the common metabolite
1,2,4-triazole and two triazole conjugates (triazole alanine and
triazole acetic acid). Refer to EPA's recent tolerance rulemaking on
tebuconazole in the Federal Register of May 14, 2008 (73 FR 27748-
27756, FRL-8364-6), for more information on this risk assessment.
D. Safety Factor for Infants and Children
In the Federal Register of May 14, 2008 (73 FR 27748-27756, FRL-
8364-6) the Agency published a Final rule establishing tolerances for
residues of tebuconazole in or on various food commodities. When the
Agency conducted the risk assessments in support of that tolerance
action, it also assessed dietary exposure to tebuconazole assuming that
all of the tolerances in this action were in place. Accordingly, EPA
relies on the decision on the FQPA safety factor for infants and
children as set out in that action. Refer to EPA's recent tolerance
rulemaking on tebuconazole, available at https://www.regulations.gov,
for a detailed discussion and selection of a safety factor for infants
and children for tebuconazole. For the reasons explained there, EPA
reduced the FQPA safety factor to 3X for all potential exposure
scenarios.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD represent the highest safe exposures, taking into account
all appropriate safety factors (SFs). EPA calculates the aPAD and cPAD
by dividing the point of departure (POD) by all applicable uncertainty
factors (UFs). For linear cancer risks, EPA calculates the probability
of additional cancer cases given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the POD to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
Below, EPA has summarized the conclusions from its recent tolerance
rulemaking on tebuconazole which took into account exposure to
tebuconazole from the food commodities covered by the tolerances in
this action. Refer to EPA's recent tolerance rulemaking on
tebuconazole, available at https://www.regulations.gov, for a detailed
discussion of EPA's safety determinations.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to tebuconazole will occupy 53% of the aPAD for the population group
(all infants less than 1 year old) receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
tebuconazole from food and water will utilize 4% of the cPAD for the
U.S. population and 11% of the cPAD for the most highly exposed
population group (infants less than 1 year old).
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Tebuconazole
is currently registered for uses that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to tebuconazole.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the short-term aggregate MOE
from dietary exposure (food + drinking water) and non-occupational/
residential handler exposure for adults using a hose-end sprayer on
ornamentals is 400. The short-term aggregate MOE from dietary exposure
and exposure from golfing is 1,800. The short-term aggregate MOE to
children from dietary exposure and exposure from wood surfaces treated
at the above ground use rate is 530. The short-term aggregate MOE to
children from dietary exposure and exposure to wood surfaces treated at
the below ground use rate is 230. The combined and aggregate MOEs for
wood treated for below ground uses exceed the Agency's LOC of 300, and
indicate a potential risk of concern. However, the MOE of 230 is based
on unrealistic assumptions and EPA has concluded that aggregate
[[Page 47070]]
exposure does not pose a risk of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Tebuconazole is currently registered for uses that could result
in intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to tebuconazole.
Since the POD, relevant exposure scenarios and exposure
assumptions used for intermediate-term aggregate risk assessments are
the same as those used for short-term aggregate risk assessments, the
short-term aggregate risk assessments represent and are protective of
both short- and intermediate-term exposure durations.
5. Aggregate cancer risk for U.S. population. Although tebuconazole
is classified as a Group C Carcinogen-Possible Human Carcinogen, the
Agency has concluded that the chronic RfD is protective of the cancer
effects.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to tebuconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate gas chromatography/nitrogen phosphorus detection and
liquid chromatography/mass spectrometry/mass spectrometry (GC/NPD and
LC/MS/MS) methods are available for enforcing tolerances for
tebuconazole and its metabolites in plant commodities, livestock
matrices and processing studies. The methods have been adequately
validated by an independent laboratory in conjunction with a previous
petition. The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are currently Codex, Canadian and Mexican maximum residue
limits (MRLs) for residues of tebuconazole in or on a variety of plant
and livestock commodities. The tolerance definition for residues in
plants is tebuconazole, per se, for Codex, Canada, and Mexico. For
livestock commodities, the tolerance expression is for the combined
residues of tebuconazole and HWG 2061 in the United States and Canada,
and tebuconazole, per se, for Codex. Where possible, the proposed
tolerance levels have been harmonized with the MRLs from Canada,
Mexico, and Codex. With regard to the pome fruit tolerance, the Agency
recommended tolerance of 0.05 ppm differs from the Codex MRL of 0.5 mg/
kg. Harmonization of the pome fruit tolerances is not possible because
U.S. data were derived using long pre-harvest intervals (PHIs) of 75-
129 days while Italian data were derived using maximum PHIs of 14 days.
With regard to the cucurbit vegetable tolerance, the Agency recommended
tolerance of 0.09 ppm for vegetable, cucurbit, group 9, differs from
the Codex MRL of 0.2 mg/kg on cucumber and 0.02 mg/kg on summer squash.
The Agency notes that some of the cucumber data from Spain were derived
from trials conducted in greenhouses. Although the application rate
used for the Spanish trials was similar to the trials conducted in the
United States, it is quite normal for greenhouse trials to give higher
residues. If the greenhouse trials are ignored, then the remaining
Codex data are in the 0.02 - 0.04 range, consistent with the U.S. data
and tolerance. In short, the higher Codex MRL for cucumber accommodates
the greenhouse use.
C. Response to Comments
The Agency received a comment from a citizen of New Jersey. The
commenter questioned the necessity of using taxpayer money through the
agency of the Interregional Research Project No. 4 to develop
pesticides, challenged the appropriateness of conducting some of the
tebuconazole field trials outside of the United States, expressed
concern over whether specific warnings were given to residents of New
Jersey prior to conducting field trials in that State, and worried that
students at Rutgers University may have been injured in the
tebuconazole toxicological tests on animals that were performed at that
facility.
In response, as to the commenter's concern with field trials that
were conducted in countries other than the United States, EPA notes
that frequently field trials are conducted in other countries as well
as in the United States so that EPA can understand the range of
pesticide residues that may be present on a food. EPA received several
applications for tebuconazole import tolerances and it is appropriate
that the field trials would be conducted in the countries where the
pesticide was to be used. Additionally, some tebuconazole import
tolerances were proposed with foreign data, and then a U.S. use was
proposed and U.S. data submitted. None of the other comments address
the findings made in this action regarding the establishment of a
tolerance. Nonetheless, EPA provides the following information
regarding the comments. IR-4 was established by the USDA to help minor
acreage; specialty crop producers obtain EPA tolerances and new
registered uses of pesticides. As to whether warnings were given to
residents of New Jersey regarding field trials, EPA would point out
that experimental field trials are subject to EPA regulations at 40 CFR
part 172. EPA also has regulations governing the toxicological data
testing laboratories that are designed to insure data quality (40 CFR
part 160). Federal jurisdiction concerning the safety of workers in
testing laboratories would be under the Occupational Safety and Health
Administration in the U.S. Department of Labor. EPA has responded to
similar comments from this commenter on previous occasions. Refer to 70
FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), and 69 FR 63083
(October 29, 2004).
D. Revisions to Petitioned-for Tolerances
Based upon review of the data supporting the petitions, EPA
determined that the proposed tolerances should be revised as follows:
Cotton, gin byproducts at 25.0 ppm; asparagus at 0.05 ppm; coffee,
green bean at 0.15 ppm; coffee, roasted bean, at 0.3 ppm; onion, bulb,
subgroup 3-07A at 0.2 ppm; corn, field, grain at 0.05 ppm; corn, field,
forage at 4.0 ppm; corn, field, stover at 3.5 ppm; corn, pop, grain at
0.05 ppm; corn, pop, stover at 3.5 ppm; corn, sweet, forage at 7.0 ppm;
corn, sweet, stover at 6.0 ppm; turnip, tops (limited to east of the
Rockies) at 7.0 ppm; turnip, roots at 0.5 ppm; beet, garden, tops at
7.0 ppm; beet, garden, root at 0.70; hop, dried cones at 35.0 ppm;
vegetable, cucurbit, group 9 at 0.09 ppm; mango, postharvest at 0.15
ppm; plum, pre- and post-harvest at 1.0 ppm; okra at 1.2 ppm; lychee at
1.6 ppm; soybean, seed at 0.08 ppm; soybean, forage at 25 ppm; soybean,
hay at 50 ppm; and grain, aspirated fractions 16.0 ppm. A separate
tolerance is required for apple, wet pomace at 0.1 ppm. No tolerance is
required for soybean hulls. A tolerance of 1.3 ppm is required for
onion, green, subgroup 3-07B. The tolerance proposed by IR-4 for hops
(PP 9E6046) is covered by the registrant proposed tolerance for hops,
dried cones (PP 4E6842). EPA revised
[[Page 47071]]
most of these tolerance levels based on analysis of the residue field
trial data using the Agency's Tolerance Spreadsheet in accordance with
the Agency's Guidance for Setting Pesticide Tolerances Based on Field
Trial Data Standard Operating Procedure (SOP). For the proposed
tolerances on asparagus; corn, field, grain; and by translation corn,
pop grain the tolerance could not be set lower than the limit of
quantitation (LOQ) of the enforcement analytical method, which was 0.05
ppm for tebuconazole. For corn, field, forage, the proposed tolerance
was raised to 4.0 ppm based on the maximum residue level in the field
trials.
Additionally, IR-4 petitioned for a tolerance on bulb vegetables
group 3 as that crop group was defined at the time of the petition
(6E7097). In the Federal Register of December 7, 2007 (72 FR 69150-
69158) (FRL-8340-6), EPA issued a final rule that revised the crop
grouping regulations. EPA indicated in the December 7, 2007 final rule
as well as the earlier May 23, 2007 proposed rule (72 FR 28920-28930)
that, for existing petitions for which a Notice of Filing had been
published, the Agency would attempt to conform these petitions to the
rule. As part of this action, EPA expanded and revised bulb vegetables
group 3. Changes to crop group 3 (bulb vegetables) included adding new
commodities, creating subgroups for bulb and green onions, and changing
the name of one of the representative commodities from ``onion, dry
bulb'' to ``onion, bulb''. The Bayer proposed tolerance for garlic
(bulb) and onion (bulb) with no U. S. registration was superseded by
the proposed tolerance for bulb vegetables. The proposed tolerance on
bulb vegetables group 3 was determined to be inappropriate because the
residues were found to be more than a factor of 5x. Thus, separate
tolerances were set for the crop subgroups, onion, bulb, subgroup 3-07A
at 0.2 ppm, and onion, green, subgroup 3-07B at 1.3 ppm.
EPA concludes it is reasonable to revise the petitioned-for
tolerance so that they agree with the recent crop grouping revisions
because (1) although the new crop groups/subgroups include several new
commodities, the added commodities are closely related minor crops
which contribute little to overall dietary or aggregate exposure and
risk; and tebuconazole exposure from these added commodities was
considered when EPA conducted the dietary and aggregate risk
assessments supporting this action; and (2) the representative
commodities for the revised crop groups/subgroups have not changed.
Finally, the proposed tolerance for hops, domestically grown, in PP
4E6046, was superseded by the proposed tolerance for hops, dry cone
(based on data for imported hops) in PP 4E6842, since the latter
proposed tolerance is higher, 30.0 ppm. The proposed tolerance for
asparagus (domestic) at 0.2 ppm, in PP 6E7036, superseded the proposed
tolerance for imported asparagus at 0.1 ppm, in PP 0E6091. The
tolerances for inadvertent residues of tebuconazole in soybeans planted
in rotation with treated wheat in PP 0F6129, were superseded by the
proposed tolerance for soybean following a direct treatment of
tebuconazole in PP 4F6854.
V. Conclusion
Therefore, tolerances are established for residues of the fungicide
tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on food commodities
apple, wet pomace at 0.1 ppm; asparagus at 0.05 ppm; bean, succulent at
0.1 ppm; bean, dry seed at 0.1 ppm; beet, garden, tops at 7.0 ppm;
beet, garden, roots at 0.70 ppm; brassica, leafy greens, subgroup 5B at
2.5 ppm; coffee, green bean at 0.15 ppm; coffee, roasted bean at 0.3
ppm; corn, field, grain at 0.05 ppm; corn, field, forage at 4.0 ppm;
corn, field, stover at 3.5 ppm; corn, pop, grain at 0.05 ppm; corn,
pop, stover at 3.5 ppm; corn, sweet, kernel plus cob with husks removed
at 0.5 ppm; corn, sweet, forage at 7.0 ppm; corn, sweet, stover at 6.0
ppm; cotton, undelinted seed at 2.0 ppm; cotton, gin byproducts at 25.0
ppm; Fruit, pome, group 11 at 0.05 ppm; fruit, stone, group 12, except
cherry at 1.0 ppm; grain, aspirated fractions at 16.0 ppm; hop, dried
cones at 35.0 ppm; lychee at 1.6 ppm; mango, postharvest at 0.15 ppm;
okra at 1.2 ppm; onion, bulb, subgroup 3-07A at 0.2 ppm; onion, green,
subgroup 3-07B at 1.3 ppm; plum, pre- and post-harvest at 1.0 ppm;
soybean, forage at 25 ppm; soybean, hay at 50 ppm; soybean, seed at
0.08 ppm; sunflower, seed at 0.05 ppm; sunflower, meal at 0.2 ppm;
sunflower, refined oil at 0.2 ppm; vegetable, cucurbit, group 9 at 0.09
ppm; turnip, roots at 0.5 ppm; and turnip, tops at 7.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petitions submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
[[Page 47072]]
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 29, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180. 474 is amended by revising the introductory text of
paragraph (a)(1), by alphabetically adding the following commodities to
the table in paragraph (a)(1); by removing the text from paragraph (b)
and reserving the paragraph designation and heading; and by adding a
new paragraph (c).
Sec. 180.474 Tebuconazole; tolerances for residues.
(a) General. (1) Tolerances are established for the residues of the
fungicide, tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol in or on the following
commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Apple, wet pomace............................................ 0.1
Asparagus.................................................... 0.05
* * * * *
Bean, succulent.............................................. 0.1
Bean, dry seed............................................... 0.1
Beet, garden, roots.......................................... 0.70
Beet, garden, tops........................................... 7.0
Brassica, leafy greens, subgroup 5B.......................... 2.5
Coffee, green bean\1\........................................ 0.15
Coffee, roasted bean\1\...................................... 0.3
Corn, field, grain........................................... 0.05
Corn, field, forage.......................................... 4.0
Corn, field, stover.......................................... 3.5
Corn, pop, grain............................................. 0.05
Corn, pop, stover............................................ 3.5
Corn, sweet, kernel plus cob with husks removed.............. 0.5
Corn, sweet, forage.......................................... 7.0
Corn, sweet, stover.......................................... 6.0
Cotton, undelinted seed...................................... 2.0
Cotton, gin byproducts....................................... 25.0
Fruit, pome, group 11........................................ 0.05
Fruit, stone, group 12, except cherry........................ 1.0
Grain, aspirated fractions................................... 16.0
* * * * *
Hop, dried cones............................................. 35.0
Lychee....................................................... 1.6
Mango, postharvest........................................... 0.15
* * * * *
Okra......................................................... 1.2
Onion, bulb, subgroup 3-07A.................................. 0.2
Onion, green, subgroup 3-07B................................. 1.3
* * * * *
Plum, pre- and post-harvest.................................. 1.0
* * * * *
Soybean, forage.............................................. 25
Soybean, hay................................................. 50
Soybean, seed................................................ 0.08
Sunflower, seed.............................................. 0.05
Sunflower, meal.............................................. 0.2
Sunflower, refined oil....................................... 0.2
Vegetable, cucurbit, group 9................................. 0.09
* * * * *
------------------------------------------------------------------------
\1\There are no U.S. registrations as of 7/31/2008.
* * * * *
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. Tolerances with
regional registrations for the residues of the fungicide, tebuconazole,
alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-
triazole-1-ethanol in or on the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Turnip, roots................................................ 0.5
Turnip, tops................................................. 7.0
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-18625 Filed 8-12-08; 8:45 am]
BILLING CODE 6560-50-S