Federal Register, Volume 74, Number 41, March 4, 2009, Pages 9343-9564 Page: 9,357
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Federal Register/Vol. 74, No. 41/Wednesday, March 4, 2009/Rules and Regulations
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA-
HQ-OPP-2005-0097, by one of the
following methods:
* Federal eRulemaking Portal: http://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
* Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001.
* Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility'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 December 3,
2008 (73 FR 73640) (FRL-8390-4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 8E7428) by
Interregional Research Project Number 4
(IR-4), 500 College Road East, Suite 201
W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.474 be
amended by raising the existing
tolerance 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 raw agricultural
commodity cherry from 4.0 parts per
million (ppm) to 5.0 ppm. That notice
referenced a summary of the petition
prepared on behalf of IR-4 by Bayer
CropScience LP, the registrant, which is
available to the public in the docket,
http://www.regulations.gov.
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 inresidential 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
in or on the raw agricultural commodity
cherry, sweet, pre- and post-harvest, and
cherry, tart, pre- and post-harvest, at 5.0
ppm. EPA's assessment of exposures
and risks associated with establishing
tolerances follows.
In the Federal Register of August 13,
2008 (73 FR 47065) (FRL-8376-2), the
Agency published a Final Rule
establishing tolerances for residues of
the fungicide tebuconazole in or on
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. When the
Agency conducted the risk assessment
in support of the August, 2008 tolerance
action, it considered the proposed use of
tebuconazole on cherry, pre- and post-harvest. Since EPA considered the
cherry use in its most recent risk
assessments, establishing the tolerance
on cherry, pre- and post-harvest will not
change the estimated aggregate risks
resulting from use of tebuconazole, as
discussed in the August 13, 2008
Federal Register. Refer to this Federal
Register document, available at http://
www.regulations.gov, for a detailed
discussion of the aggregate risk
assessments and determination of
safety. EPA relies upon those risk
assessments and the findings made in
the Federal Register document in
support of this action.
Based on the risk assessments
discussed in the final rule published in
the Federal Register of August 13, 2008,
EPA concludes that there is a reasonable
certainty that no harm will result to the
general population, and to infants and
children from aggregate exposure to
tebuconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography/nitrogen
phosphorus detection and liquid
chromatography/mass spectrometry/
mass spectrometry (GC/NPD and LC/
MS/MS)) is 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
Codex maximum residue limits
(MRLs) have been established for
residues of tebuconazole in or on cherry
at 5.0 ppm. Establishing a permanent
U.S. tolerance for tebuconazole in or on
cherry, pre- and post-harvest at 5.0 ppm
results in MRL harmonization between
Codex and the United States.
V. Conclusion
Therefore, a tolerance is established
for residues of tebuconazole, alpha-[2-
(4-Chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-
ethanol, in or on cherry, sweet, pre- and
post-harvest, cherry, tart, pre- and post-
harvest at 5.0 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerancesunder section 408(d) of FFDCA in
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United States. Office of the Federal Register. Federal Register, Volume 74, Number 41, March 4, 2009, Pages 9343-9564, periodical, March 4, 2009; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc132903/m1/22/: accessed April 23, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.