Federal Register, Volume 75, Number 22, February 3, 2010, Pages 5481-5674 Page: 5,523
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Federal Register/Vol. 75, No. 22/Wednesday, February 3, 2010 /Rules and Regulations
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
cite at http://www.gpoaccess.gov/ecfr.
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-2008-0262 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 April 5, 2010.
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-2008-0262, 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 November
5, 2008 (73 FR 65851) (FRL-8385-1),
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 8F7398) by Bayer
CropScience, P.O. Box 12014, 2 T. W.Alexander Dr., Research Triangle Park,
NC 27709. The petition requested that
40 CFR 180.607 be amended by
establishing tolerances for the
inadvertent or indirect combined
residues of the insecticide spiromesifen
(2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro [4.4]non-3-en-4-yl 3,3-
dimethylbutanoate), its enol metabolite
(4-hydroxy-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-2-one), and its
metabolites containing the 4-
hydroxymethyl moiety (4-hydroxy-3-[4-
(hydroxymethyl)-2,6-dimethylphenyl]-
1-oxaspiro[4.4]non-3-en-2-one),
calculated as the parent compound
equivalents, in or on the following
commodities from crops grown as
rotational crops: vegetable, bulb, group
3-07 at 0.07 parts per million (ppm).
That notice is available to the public in
the docket, http://www.regulations.gov.
One comment was received on the
notice of filing. EPA's response to this
comment is discussed in Unit IV.C.
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 inadvertent or indirect
combined residues of spiromesifen, (2-
oxo-3-(2,4,6- trimethylphenyl)-l-
oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate), its enol metabolite
(4-hydroxy-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-2-one), and itsmetabolites containing the 4-
hydroxymethyl moiety (4-hydroxy-3-[4-
(hydroxymethyl)-2,6-dimethylphenyl]-
1-oxaspiro[4.4]non-3-en-2-one),
calculated as the parent compound
equivalents, on the following
commodities from crops grown as
rotational crops: vegetable, bulb, group
3-07. 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.
Spiromesifen shows low acute
toxicity via the oral, dermal and
inhalation routes of exposure. It was
neither an eye nor dermal irritant, but
showed moderate potential as a contact
sensitizer. In short- and long-term
animal toxicity tests, the critical effects
observed were loss of body weight,
adrenal effects (discoloration, decrease
in fine vesiculation, and the presence of
cytoplasmic eosinophilia in zona
fasciculata cells), thyroid effects
(increased thyroid stimulating hormone,
increased thyroxine binding capacity,
decreased T3 and T4 levels, colloidal
alteration and thyroid follicular cell
hypertrophy), liver effects (increased
alkaline phosphatase, ALT and
decreased cholesterol, triglycerides),
and spleen effects (atrophy, decreased
spleen cell count, and increased
macrophages). Spiromesifen shows no
significant developmental or
reproductive effects, is not likely to be
carcinogenic based on bioassays in rats
and mice, and lacks in vivo and in vitro
mutagenic effects. Spiromesifen is not
considered a neurotoxic chemical based
on the chemical's mode of action and
the available data from multiple studies,
including acute and subchronic
neurotoxicity studies.
Specific information on the studies
received and the nature of the adverse
effects caused by spiromesifen as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the
toxicity studies can be found at http://
www.regulations.gov in the document
"Spiromesifen: Human-Health Risk
Assessment for Request to Reduce
Rotational Crop Plantback Interval (PBI)
for Bulb Vegetables (Crop Group 3)," at
pages 11-16 in docket ID number EPA-
HQ-OPP-2008-0262 and memo,D363706, June 11, 2009.
5523
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United States. Office of the Federal Register. Federal Register, Volume 75, Number 22, February 3, 2010, Pages 5481-5674, periodical, February 3, 2010; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc52605/m1/49/: accessed April 23, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.