Federal Register, Volume 74, Number 41, March 4, 2009, Pages 9343-9564 Page: 9,371
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Federal Register/Vol. 74, No. 41/Wednesday, March 4, 2009/Rules and Regulations
were healthy. No other potential
immunotoxicity effects were evident in
the toxicity database for fluazifop-P-
butyl. The liver and kidney are the
primary target organs and the most
sensitive species is the rat (due to longer
retention time of the major metabolite in
this species). Based on these
considerations, EPA does not believe
that conducting a special series
870.7800 immunotoxicity study will
result in a point of departure less than
the NOAEL of 0.74 milligram/kilogram/
day used in calculating the cPAD for
fluazifop-P-butyl; therefore, an
additional database uncertainty factor is
not needed to account for potential
immunotoxicity.
ii. There is no indication that
fluazifop-P-butyl is a neurotoxic
chemical at relevant exposure levels and
there is no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity.
iii. There are no residual uncertainties
for prenatal and/or postnatal toxicity.
iv. There are no residual uncertainties
identified in the exposure databases.
The chronic dietary food exposure
assessments were performed based on
reliable data on average residue levels
observed in applicable field trials and
PCT. Chronic exposure will not be
underestimated. EPA made conservative
(protective) assumptions in the ground
and surface water modeling used to
assess exposure to fluazifop-P-butyl in
drinking water. EPA used similarly
conservative assumptions to assess post
application exposure of children as well
as incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by fluazifop-P-butyl.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. Using the exposure
assumptions discussed in this unit foracute exposure, the acute dietary
exposure from food and water to
fluazifop-P-butyl will occupy 12.1% of
the aPAD for (females 13-49 years old)
the population group receiving the
greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to fluazifop-P-
butyl from food and water will utilize
74.9% of the cPAD for (children 1-2
years old) the population group
receiving the greatest exposure. Based
on the explanation in Unit III.C.3.,
regarding residential use patterns,
chronic residential exposure to residues
of fluazifop-P-butyl is not expected.
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).
Fluazifop-P-butyl 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
fluazifop-P-butyl.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures aggregated result
in aggregate margins of exposure
(MOEs) of 150 for the general U.S.
population, 150 for adult females and
240 for children; all below EPA's level
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).
Fluazifop-P-butyl is not registered for
any use patterns that would result in
intermediate-term residential exposure.
Therefore, the intermediate-term
aggregate risk is the sum of the risk from
exposure to fluazifop-P-butyl through
food and water, which has already been
addressed, and will not be greater than
the chronic aggregate risk.
5. 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 fluazifop-P-
butyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology(gas chromatography-mass
spectrometry) is available to enforce the
tolerance expression. 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 no Codex Maximum
Residue Limits (MRLs) established for
fluazifop residues. Canada has
established a 1 ppm tolerance for
fluazifop-butyl calculated as the acid in
soybeans, and a Mexico MRL is
established for fluazifop-p-butyl in soya
at 1 ppm. The proposed U.S. tolerances
cannot be harmonized with the
Canadian or Mexican MRLs for soybean,
because higher residues were observed
in the U.S. crop field trials.
C. Response to Comments
Public comments were received from
B. Sachau who objected to the proposed
tolerances because of the amounts of
pesticides already consumed and
carried by the American population.
She further indicated that testing
conducted on animals have absolutely
no validity and are cruel to the test
animals. B. Sachau's comments
contained no scientific data or evidence
to rebut the Agency's conclusion that
there is a reasonable certainty that no
harm will result from aggregate
exposure to fluazifop-P-butyl, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information. EPA has responded
to B. Sachau's generalized comments on
numerous previous occasions, 70 FR
1349-1354 (January 7, 2005); 69 FR
63083- 63096 (October 29, 2004).
V. Conclusion
Therefore, tolerances are established
for residues of fluazifop-P-butyl,
butyl(R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, and
the free and conjugated forms of the
resolved isomer of fluazifop, (R)-2-[4-
[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoic acid,
expressed as fluazifop, in or on beans,
dry, seed; peanut; peanut, meal; and
soybean, seed at 50 ppm, 1.5 ppm, 2.2
ppm, and 2.5 ppm, respectively.
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 ExecutiveOrder 12866, entitled Regulatory
9371
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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/m1/36/: accessed March 18, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.