Federal Register, Volume 74, Number 41, March 4, 2009, Pages 9343-9564 Page: 9,368
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Federal Register/Vol. 74, No. 41/Wednesday, March 4, 2009/Rules and Regulations
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at http://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the "Federal Register" listings at
http://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA's tolerance
regulations at 40 CFR part 180 through
the Government Printing Office's e-CFR
site at http://www.gpoaccess.gov/ecfr.
To access the OPPTS Harmonized
Guidelines referenced in this document,
go directly to the guidelines at http://
www.epa.gpo/opptsfrs/home/
guidelin.htm.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA-HQ-
OPP-2008-0066 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 May 4, 2009.
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-2008-0066, 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 DocketFacility'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 February 6,
2008 (73 FR 6964) (FRL-8350-9), 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 7F7289) by
Syngenta Crop Protection, Inc., P.O. Box
18300, Greensboro, NC 27419. The
petition requested that 40 CFR 180.411
be amended by establishing tolerances
for residues of the herbicide fluazifop-
P-butyl, butyl(R)-2-[4-[[5-
(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, in
or on dry beans at 25 parts per million
(ppm); peanuts at 1.5 ppm; soybean at
2.5 ppm; soybean meal at 2.5 ppm; and
soybean refined oil at 0.01 ppm. That
notice referenced a summary of the
petition prepared by Syngenta Crop
Protection, Inc., the registrant, which is
available to the public in the docket,
http://www.regulations.gov. Comments
were received on the notice of filing.
EPA's response to these comments is
discussed in Unit IV.C.
Based upon review of the field trial
data supporting the petition and to
harmonize with the Food and Feed
Commodity Vocabulary at http://
www.epa.gov/opphedOl/foodfeed/
index.htm. EPA has amended the
commodity listing to read: Beans, dry,
seed at 50 ppm; peanut at 1.5 ppm;
peanut, meal at 2.2 ppm; and soybean,
seed at 2.5 ppm. EPA is also editorially
combining the tolerance sections and
correcting the tolerance expressions to
delete references to the unresolved
isomer fluazifop-butyl that is no longer
a registered pesticide under FIFRA.
Background information is provided in
the docket associated fluazifop-P-butyl;
Tolerance Reassessment Decision. The
Notice of Availability was published in
the Federal Register of October 21, 2005
(70 FR 61287) (FRL-7726-2).
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, includingall 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 fluazifop-P-
butyl on beans, dry, seed; peanut;
peanut, meal; and soybean, seed at 50
ppm, 1.5 ppm, 2.2 ppm, 2.5 ppm,
respectively. EPA's assessment of
exposures and risks associated with
establishing tolerances follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
In characterizing the toxicity of
fluazifop-P-butyl, EPA considered data
on both fluazifop-P-butyl and fluazifop-
butyl. Fluazifop-P-butyl is the purified
(R) enantiomer of the mixed isomeric
(RS) fluazifop-butyl product and the
data show them to be toxicological
equivalent. Fluazifop-P-butyl has shows
no indication of being an eye or skin
irritant in acute or 21-day dermal
studies, and is not a skin sensitizer.
Fluazifop-P-butyl does show similar
toxicity by both the inhalation and oral
routes because of its metabolization by
blood into the acid form and excretion
in this manner. The liver and kidney
have demonstrated to be its target
organs expressed for the most part as
liver toxicity in the presence of
peroxasome proliferation and
exacerbation of age related kidney
toxicity. In general, there were no
carcinogenicity concerns in any
acceptable studies in the rat with
fluazifop-butyl or in the hamster for
fluazifop-P-butyl. The hamster wasselected for cancer study because liver
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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/m1/33/: accessed March 19, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.