Flubendiamide; Pesticide Tolerances, 47057-47063 [E8-18324]
Download as PDF
Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations
Department that it is funding an OTRB
or Other Than Urbanized grant by
transmitting to the Department an
information copy of each grant
application upon approval of the grant.
(i) Each grant of assistance for an
Other Than Urbanized program will
contain a labor section identifying labor
organizations representing transit
employees of each subrecipient, the
labor organizations representing
employees of other transit providers in
the service area, and a list of those
transit providers. A sample format is
posted on the OLMS Web site to
facilitate the inclusion of this
information in the grant application.
(ii) OTRB grants of assistance will
contain a labor section identifying labor
organizations representing employees of
the recipient.
(2) The Department will notify labor
organizations representing potentially
affected transit employees of the
approval of Other Than Urbanized and
OTRB grants and inform them of their
rights under the Special Warranty
Arrangement.
§ 215.8
[Amended]
8. Section 215.8 is amended as
follows:
I a. Remove ‘‘Director,’’ and add in its
place ‘‘Chief, Division of’’;
I b. Remove ‘‘Suite N5603,’’; and
I c. Add the phrase ‘‘or e-mailed to
OLMS-TransitGrant@dol.gov’’ at the end
of the paragraph.
I
Signed at Washington, DC, this 4th day of
August, 2008.
Victoria A. Lipnic,
Assistant Secretary for Employment
Standards.
Donald Todd,
Deputy Assistant Secretary, Office of LaborManagement Standards.
[FR Doc. E8–18497 Filed 8–12–08; 8:45 am]
BILLING CODE 4510–CP–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0099; FRL–8360–2]
Flubendiamide; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
hsrobinson on PROD1PC76 with RULES
AGENCY:
I. General Information
SUMMARY: This regulation establishes
tolerances for residues of the insecticide
flubendiamide per se, N2-[1,1-Dimethyl2-(methylsulfonyl)ethyl-3-iodo-N1-[2methyl-4-[1,2,2,2-tetrafluoro-1(trifluoromethyl)ethyl]phenyl]-1,2-
VerDate Aug<31>2005
15:55 Aug 12, 2008
Jkt 214001
benzenedicarboxamide, in or on certain
food and raw agricultural commodities.
Bayer CropScience, LP in c/o Nichino
America, Inc. (U.S. subsidiary of Nihon
Nohyaku Co., Ltd.) requested these
tolerances under the Federal Food, Drug
and Cosmetic Act (FFDCA).
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–2007–0099. 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 Room S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA 22202–4501. 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:
Carmen Rodia, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460–0001; telephone
number: (703) 306–0327; e-mail address:
rodia.carmen@epa.gov.
SUPPLEMENTARY 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
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
47057
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. To access the OPPTS Harmonized
Guidelines referenced in this document,
go directly to the guidelines at https://
www.epa.gpo/opptsfrs/home/
guidelin.htm.
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–2007–0099 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
E:\FR\FM\13AUR1.SGM
13AUR1
47058
Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations
hsrobinson on PROD1PC76 with RULES
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–2007–0099, 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 Avenue, NW.,
Washington, DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Room S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA 22202–
4501. 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 February
28, 2007 (72 FR 9000) (FRL–8115–2),
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 6F7065) by Bayer
CropScience, LP in c/o Nichino
America, Inc. (U.S. subsidiary of Nihon
Nohyaku Co., Ltd.), P.O. Box 12014,
Research Triangle Park, NC 27709–2014.
The petition requested that 40 CFR part
180 be amended by establishing
permanent tolerances in primary crops
for residues of the insecticide
flubendiamide, N2-[1,1-Dimethyl-2(methylsulfonyl)ethyl-3-iodo-N1-[2methyl-4-[1,2,2,2-tetrafluoro-1(trifluoromethyl)ethyl]phenyl]-1,2benzenedicarboxamide, in or on the
following raw agricultural and
processed commodities: Almond, hulls
at 9.0 parts per million (ppm); brassica,
head and stem subgroup at 0.60 ppm;
brassica, leafy greens subgroup at 6.0
ppm; corn, field, forage at 8.0 ppm;
corn, corn, field, grain at 0.02 ppm;
field, stover at 15.0 ppm; corn, pop,
grain at 0.02 ppm; corn, pop, stover at
15.0 ppm; corn, sweet, forage at 9.0
ppm; corn, sweet, kernel plus cob with
husks removed at 0.02 ppm; corn,
sweet, stover at 25.0 ppm; cottonseed at
2.0 ppm; cotton, gin byproduct at 60.0
ppm; fruit, pome group at 0.7 ppm;
fruit, stone group at 1.6 ppm; grape at
1.4 ppm; nut, tree group at 0.06 ppm;
okra at 0.30 ppm; vegetable, cucurbit
group at 0.20 ppm; vegetable, fruiting
VerDate Aug<31>2005
15:55 Aug 12, 2008
Jkt 214001
group at 0.30 ppm and vegetable, leafy,
except brassica at 11.0 ppm; in or on the
following rotational crop commodities:
Alfalfa, forage at 0.15 ppm; alfalfa, hay
at 0.04 ppm; barley, hay at 0.04 ppm;
barley, straw at 0.07 ppm; buckwheat at
0.07 ppm; clover, forage at 0.15 ppm;
clover, hay at 0.04 ppm; grass, forage at
0.15 ppm; grass, hay at 0.04 ppm; grass,
silage at 0.27 ppm; millet, pearl, forage
at 0.15 ppm; millet, pearl hay at 0.04
ppm; millet, proso, forage at 0.15 ppm;
millet, proso, hay at 0.04 ppm; millet,
proso, straw at 0.07 ppm; oats, forage at
0.15 ppm; oats, hay at 0.04 ppm; oats,
straw at 0.07 ppm; rye, forage at 0.15
ppm; rye, straw at 0.07 ppm; sorghum,
grain, forage at 0.03 ppm; sorghum,
grain, stover at 0.06 ppm; soybean,
forage at 0.02 ppm; soybean, hay at 0.04
ppm; teosinte, forage at 0.15 ppm;
teosinte, hay at 0.04 ppm; teosinte,
straw at 0.07 ppm; triticale, forage at
0.15 ppm; triticale, hay at 0.04 ppm;
triticale, straw at 0.07 ppm; wheat,
forage at 0.15 ppm; wheat, hay at 0.03
ppm and wheat, straw at 0.03 ppm; and
in the following livestock commodities:
Cattle, fat at 0.80 ppm; cattle, kidney at
0.60 ppm; cattle, liver at 0.60 ppm;
cattle, muscle at 0.10 ppm; eggs at 0.03
ppm; goat, fat at 0.80 ppm; goat, kidney
at 0.60 ppm; goat, liver at 0.60 ppm;
goat, muscle at 0.10 ppm; hog, fat at
0.80 ppm; hog, kidney at 0.60 ppm; hog,
liver at 0.60 ppm; hog, muscle at 0.10
ppm; horse, fat at 0.80 ppm; horse,
kidney at 0.60 ppm; horse, liver at 0.60
ppm; horse, muscle at 0.10 ppm; milk
at 0.20 ppm; poultry, fat at 0.08 ppm;
poultry, liver at 0.03 ppm; poultry,
muscle at 0.01 ppm; sheep, fat at 0.80
ppm; sheep, kidney at 0.60 ppm; sheep,
liver at 0.60 ppm; and sheep, muscle at
0.10 ppm. That notice referenced a
summary of the petition prepared by
Bayer CropScience, LP in c/o Nichino
America, Inc. (U.S. subsidiary of Nihon
Nohyaku Co., Ltd.), the registrant,
which is available to the public in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting this petition and EPA policy,
the Agency has revised commodity
definitions and/or some of the proposed
tolerances and concludes that the
establishment of the following tolerance
is appropriate for the insecticide
flubendiamide per se in or on the
following food commodities: Almond,
hulls at 9.0 ppm; apple, wet pomace at
2.0 ppm; brassica, head and stem,
subgroup 5A at 0.60 ppm; brassica,
leafy greens, subgroup 5B at 5.0 ppm;
cattle, fat at 0.30 ppm; cattle, kidney at
0.30 ppm; cattle, liver at 0.30 ppm;
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
cattle, muscle at 0.05 ppm; corn, field,
forage at 8.0 ppm; corn, field, grain at
0.02 ppm; corn, field, stover at 15 ppm;
corn, pop, grain at 0.02 ppm; corn, pop,
stover at 15 ppm; corn, sweet, forage at
9.0 ppm; corn, sweet, kernel plus cob
with husks removed at 0.01 ppm; corn,
sweet, stover at 25 ppm; cotton gin
byproducts at 60 ppm; cotton,
undelinted seed at 0.90 ppm; egg at 0.01
ppm; fruit, pome, group 11 at 0.70 ppm;
fruit, stone, group 12 at 1.6 ppm; goat,
fat at 0.30 ppm; goat, kidney at 0.30
ppm; goat, liver at 0.30 ppm; goat,
muscle at 0.05 ppm; grain, aspirated
fractions at 5.0 ppm; grape at 1.4 ppm;
horse, fat at 0.30 ppm; horse, kidney at
0.30 ppm; horse, liver at 0.30 ppm;
horse, muscle at 0.05 ppm; milk at 0.04
ppm; milk, fat at 0.30 ppm; nut, tree,
group 14 at 0.06 ppm; okra at 0.30 ppm;
poultry, fat at 0.02 ppm; poultry, liver
at 0.01 ppm; poultry, muscle at 0.01
ppm; sheep, fat at 0.30 ppm; sheep,
kidney at 0.30 ppm; sheep, liver at 0.30
ppm; sheep, muscle at 0.05 ppm;
vegetable, cucurbit, group 9 at 0.20
ppm; vegetable, fruiting, group 8 at 0.60
ppm and vegetable, leafy, except
brassica, group 4 at 11 ppm; and in or
on the following raw agricultural
commodities: Alfalfa, forage at 0.15
ppm; alfalfa, hay at 0.04 ppm; barley,
hay at 0.04 ppm; barley, straw at 0.07
ppm; buckwheat at 0.07 ppm; clover,
forage at 0.15 ppm; clover, hay at 0.04
ppm; grass, forage at 0.15 ppm; grass,
hay at 0.04 ppm; millet, pearl, forage at
0.15 ppm; millet, pearl, hay at 0.04
ppm; millet, proso, forage at 0.15 ppm;
millet, proso, hay at 0.04 ppm; millet,
proso, straw at 0.07 ppm; oats, forage at
0.15 ppm; oats, hay at 0.04 ppm; oats,
straw at 0.07 ppm; rye, forage at 0.15
ppm; rye, straw at 0.07 ppm; sorghum,
grain, forage at 0.03 ppm; sorghum,
grain, stover at 0.06 ppm; soybean,
forage at 0.02 ppm; soybean, hay at 0.04
ppm; teosinte, forage at 0.15 ppm;
teosinte, hay at 0.04 ppm; teosinte,
straw at 0.07 ppm; triticale, forage at
0.15 ppm; triticale, hay at 0.04 ppm;
triticale, straw at 0.07 ppm; wheat,
forage at 0.15 ppm; wheat, hay at 0.03
ppm and wheat, straw at 0.03 ppm.
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
E:\FR\FM\13AUR1.SGM
13AUR1
Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations
hsrobinson on PROD1PC76 with RULES
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
submitted 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 the insecticide
flubendiamide. 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.
Flubendiamide has low acute toxicity
via the oral and dermal routes, is only
a slight eye irritant, is non-irritating to
the dermis and tests negative for skin
sensitization. In the longer-term studies
in the flubendiamide mammalian
toxicology database, the primary target
organs identified were the liver, thyroid,
kidney and eyes. Liver effects reported
in rats, mice and/or dogs include organ
weight increase, periportal fatty change,
hypertrophy and minimal foci of
cellular alteration. Thyroid effects
include organ weight increase, follicular
cell hypertrophy and slight
perturbations of triiodothyronine (TC)
and thyroid stimulating hormone (TSH)
in the rat and mouse. Kidney effects
include increases in absolute and/or
relative to body kidney weights and
chronic nephropathy in the rat. Eye
effects include eye enlargement, opacity
and exophthalmus with hemorrhage and
appear only in rat pups. Other changes
include mild microcytic anemia,
decreased serum triglycerides and
cholesterol in female rat, increased
gamma glutamyl peptidase, alkaline
phosphatase and shortened activated
prothrombin time in dogs, and adrenal
VerDate Aug<31>2005
15:55 Aug 12, 2008
Jkt 214001
weight increase and an increase in
adrenal cortical cell hypertrophy in
dogs.
The hazard assessment indicated
potential toxicity resulting from
exposure to flubendiamide via different
routes over different durations. The
observed eye effects were selected as a
critical effect for the acute dietary
exposure scenario; whereas liver and
thyroid effects were determined critical
for the chronic dietary exposure
scenario. Short-term and intermediateterm dermal risks were also based on
liver and thyroid effects as well as blood
effects. Short-term and intermediateterm inhalation risks are based on liver
toxicity as well as adrenal weight
increase and an increase in adrenal
cortical cell hypertrophy.
There was no evidence of
carcinogenicity in rats and mice up to
the limit dose at 24– and 18–months,
respectively. Flubendiamide was
determined to be non-mutagenic in
bacteria, negative in an in vivo
mammalian cytogenetics assay and did
not cause unscheduled DNA synthesis
(repair of DNA damage) in mammalian
cells in vitro. Overall, there was no clear
evidence that flubendiamide was either
mutagenic or clastogenic in either in
vivo or in vitro assays. The cancer
classification is ‘‘Not Likely to be
Carcinogenic to Humans.’’
More detailed information on the
studies received and the nature of the
adverse effects caused by flubendiamide
as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL)
from the toxicity studies can be found
in the document entitled,
‘‘Flubendiamide: Human Health Risk
Assessment for Proposed Uses on Corn,
Cotton, Tobacco, Tree fruit, Tree nuts,
Vine crops and Vegetable crops,’’ dated
April 3, 2008, by going to https://
www.regulations.gov. The referenced
document is available in the docket
established by this action, which is
described under ADDRESSES, and is
identified as EPA–HQ–OPP–2007–
0099–0005 in that docket. Locate and
click on the hyperlink for docket ID
number EPA–HQ–OPP–2007–0099.
Double-click on the document to view
the referenced information on pages 65–
70 of 105.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
47059
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a Benchmark Dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-term, intermediate-term
and chronic-term risks are evaluated by
comparing food, water and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, refer to https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for flubendiamide used for
human risk assessment can be found in
the document entitled, ‘‘Flubendiamide:
Human Health Risk Assessment for
Proposed Uses on Corn, Cotton,
Tobacco, Tree fruit, Tree nuts, Vine
crops and Vegetable crops,’’ dated April
3, 2008, by going to https://
www.regulations.gov. The referenced
document is available in the docket
established by this action, which is
described under ADDRESSES, and is
identified as EPA–HQ–OPP–2007–
0099–0005 in that docket. Locate and
click on the hyperlink for docket ID
number EPA–HQ–OPP–2007–0099.
Double-click on the document to view
the referenced information on pages 37–
38 of 105.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to flubendiamide, EPA
considered exposure under the
E:\FR\FM\13AUR1.SGM
13AUR1
hsrobinson on PROD1PC76 with RULES
47060
Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations
petitioned-for tolerances and assessed
dietary exposures from flubendiamide
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 Dietary Exposure
Evaluation Model-Food Commodity
Intake Database (DEEM-FCIDTM,
Version 2.03), which incorporates food
consumption data from the U.S.
Department of Agriculture’s (USDA’s)
Nationwide Continuing Surveys of Food
Intakes by Individuals (CSFII) from
1994–1996 and 1998. The acute
assessments assumed that 100% of
crops with requested uses of
flubendiamide are treated and that all
treated crops contain residues at
tolerance-level. In addition, tolerancelevel residues for livestock commodities
were included in these analyses to
account for the potential transfer of
plant residues to livestock tissues.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA used DEEM-FCIDTM,
Version 2.03, which incorporates food
consumption data from the USDA’s
CSFII from 1994–1996 and 1998. The
chronic assessments assumed that 100%
of crops with requested uses of
flubendiamide are treated and that all
treated crops contain residues at the
average residue levels found in the crop
field trials and experimentallydetermined processing factors where
available. In addition, average-level
residues for livestock commodities were
also included in these analyses to
account for the potential transfer of
plant residues to livestock tissues.
iii. Cancer. As explained in Unit
III.A., flubendiamide is considered to be
‘‘Not Likely to be Carcinogenic to
Humans.’’ As a result, cancer exposure
assessment is not needed for
flubendiamide.
iv. Anticipated residue 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
VerDate Aug<31>2005
15:55 Aug 12, 2008
Jkt 214001
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.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for flubendiamide in drinking water.
These simulation models take into
account data on the physical, chemical
and fate/transport characteristics of
flubendiamide.
Flubendiamide is persistent and
potentially mobile in terrestrial and
aquatic environments. These fate
properties suggest that it has a potential
to move into surface and ground water.
The Agency lacks sufficient monitoring
exposure data for use in risk
assessments, as flubendiamide is a new
active ingredient. Because the Agency
does not have comprehensive
monitoring data, drinking water
concentration estimates are made by
reliance on simulation or modeling,
taking into account data on the physical
and fate characteristics of
flubendiamide. 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 the
Screening Concentration in Ground
Water (SCI-GROW) model, the estimated
drinking water concerns (EDWCs) of
flubendiamide for acute exposures are
estimated to be 12.93 parts per billion
(ppb) for surface water and 0.06 ppb for
ground water. For chronic exposures for
non-cancer assessments, the EDWCs are
estimated to be 11.95 ppb for surface
water and 0.06 ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 12.93 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 11.95 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).
Flubendiamide is not registered for any
specific use patterns that would result
in residential exposure. That is, no
residential uses are being requested for
flubendiamide at this time; therefore, no
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
residential risk assessment has been
conducted.
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.’’
EPA has not found flubendiamide to
share a common mechanism of toxicity
with any other substances, and
flubendiamide does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action; therefore, EPA has
assumed that flubendiamide does not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(c) of
FFDCA provides that EPA shall apply
an additional ten-fold (10x) margin of
safety for infants and children in the
case of threshold effects to account for
pre-natal and/or post-natal toxicity, and
the completeness of the database on
toxicity and exposure, unless EPA
determines based on reliable data that a
different margin of safety will be safe for
infants and children. This additional
margin of safety is commonly referred to
as the Food Quality Protection Act
Safety Factor (FQPA SF). In applying
this provision, EPA either retains the
default value of 10x or uses a different
additional SF when reliable data
available to EPA support the choice of
a different factor.
2. Pre-natal and post-natal sensitivity.
While both the rat and rabbit
developmental studies did not identify
teratogenic effects and showed no
evidence of increased pre-natal
susceptibility, adverse eye effects (eye
enlargement) were noted in post-natal
rat pups older than 14 days in multiple
studies (the 2–generation reproduction
and 1–generation supplemental studies)
and the developmental neurotoxicity
(DNT) study reported eye effects
appearing in some offspring between
lactation days 14 and 42, even though
exposure stopped at lactation day 21,
indicating a possible delay (a latent
response) from the time of last exposure
to onset of bupthalmos. These eye
E:\FR\FM\13AUR1.SGM
13AUR1
hsrobinson on PROD1PC76 with RULES
Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations
effects did not occur in adult rats. Since
the iris and chamber angle are
differentiating and specializing into
definite structures during post-natal
days 5–20, neonatal rats appear to have
an increased susceptibility to
flubendiamide exposure as compared to
adults. The DNT study also reported
that pre-mating exposures are not
required to elicit the eye effect in pups.
In addition to the reported eye effects in
the DNT study, there was also a balanopreputial separation (separation of the
prepuce (foreskin) from the glans penis
(balanus)) delay. While these effects are
considered adverse, they are not
assumed to be developmental effects
from in utero exposure. Even though the
delay in balanopreputial separation may
be a result of post-natal exposure
(sensitivity of the young), and the effect
is adverse, it is considered reversible
and not an indication of perinatal
sensitivity/susceptibility.
Human microsomes have been shown
to be capable of approximately 4 times
higher hydroxylation rates of
flubendiamide as compared to female
mouse microsomes and may be able to
efficiently metabolize and excrete
flubendiamide, preventing
accumulation of the parent compound.
It remains unclear whether the ability to
metabolize and clear the parent
compound is the only requirement to
avoid ocular toxicity. Due to the
potential concern for increased
susceptibility of the human neonate as
compared to adults, this perinatal ocular
effect is considered in the human health
risk assessment for flubendiamide.
3. Conclusion. EPA evaluated the
quality of the toxicity and exposure data
and, based on these data, has
determined that the safety of infants and
children would be adequately protected
if the FQPA SF were reduced to 1x. That
decision is based on the following
findings:
i. The toxicology database for
flubendiamide is complete for purposes
of this risk assessment and the
characterization of potential pre-natal
and/or post-natal risks to infants and
children. Although susceptibility was
identified in the toxicological database
(eye effects), the selected regulatory
PODs (which are based on clear
NOAELs) are protective of these effects;
therefore, the human health risk
assessment is protective.
ii. There are no treatment-related
neurotoxic findings in the acute
neurotoxicity and DNT studies in rats;
although eye effects were observed in
the DNT study. As noted in the previous
paragraph, the PODs employed in the
risk assessment are protective of this
effect.
VerDate Aug<31>2005
15:55 Aug 12, 2008
Jkt 214001
iii. There are no residual uncertainties
identified in the exposure databases and
the exposure assessment is protective.
The acute dietary food exposure
assessment utilizes tolerance-level
residues, the chronic dietary food
exposure assessment utilizes average
residue levels found in the crop field
trials/livestock commodities and both
assume 100% of crops with requested
uses of flubendiamide are treated. The
drinking water assessment generated
EDWCs using models and associated
modeling parameters which are
designed to provide conservative, health
protective, high-end estimates of water
concentrations. The highest relevant
EDWCs were used in the dietary (food
and drinking water) exposure
assessment. By using these screeninglevel exposure assessments in the acute
and chronic dietary (food and drinking
water) assessments, risk is not
underestimated for flubendiamide.
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. Shortterm, intermediate-term and chronicterm 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.
For flubendiamide, there is potential
exposure from food and drinking water,
but not from residential use sites (as
there are no proposed residential uses
for flubendiamide). Since hazard was
identified via the oral route over both
the acute and chronic duration, the
aggregate risk assessment considers
exposures from food and drinking water
consumed over the acute and chronic
durations.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
flubendiamide will occupy less than 8%
of the aPAD for the mostly highly
exposed population subgroup, children
aged 1–2 years old.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to flubendiamide
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
47061
from food and water will utilize less
than 15% of the cPAD for the mostly
highly exposed population subgroup,
children aged 1–2 years old. There are
no residential uses for flubendiamide.
3. Aggregate cancer risk for U.S.
population. Flubendiamide has been
classified as ‘‘Not Likely to be
Carcinogenic to Humans’’ and is not
expected to pose a cancer risk.
4. 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
flubendiamide residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(LC/MS/MS, Methods 00816/M002 and
00912) is available to enforce the
tolerance expression. The method may
be requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Road, Fort
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are currently no established
CODEX, Canadian or Mexican
maximum residue limits (MRLs) for
residues of flubendiamide in or on
various crop or livestock commodities.
C. Revisions to Petitioned-For
Tolerances
Based upon review of the data
submitted in support of this tolerance
petition for flubendiamide and EPA
policy, the Agency has revised
commodity definitions and/or some of
the proposed tolerances. No residue
data were submitted to support the
proposed uses on okra and popcorn.
The available field trial data for fruiting
vegetables may be translated to okra,
and the submitted data for field corn
may also be translated to popcorn. The
proposed uses on all types of corn (field,
pop and sweet) are identical.
Parent residue levels vary based on
crop (for edible commodities, residues
ranging from 0.018 ppm, corn, field,
grain to 6.7 ppm, spinach). Most crops
indicated parent residues declined with
successive sampling dates and were
determined to be available on the
surface of plants/RACs. The Agency will
allow translation of residue data from
trials conducted on rotated barley,
sorghum and wheat to support the
proposed rotational crop tolerances for
the forages, hay and straw of other types
of cereal grains and grasses. The Agency
E:\FR\FM\13AUR1.SGM
13AUR1
47062
Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations
will also allow translation of residue
data from trials conducted on rotated
soybean to support the proposed
rotational crop tolerances for the
forages, fodder, hay and straw on alfalfa
and clover to support the rotational
plant-back intervals. Based on the
transfer coefficients for livestock tissues
and the relatively low dietary burden for
swine of 0.02 ppm for flubendiamide,
tolerances for hogs are not needed.
hsrobinson on PROD1PC76 with RULES
V. Conclusion
Therefore, tolerances are established
forresidues of the insecticide
flubendiamide per se, N2-[1,1-Dimethyl2-(methylsulfonyl)ethyl-3-iodo-N1-[2methyl-4-[1,2,2,2-tetrafluoro-1(trifluoromethyl)ethyl]phenyl]-1,2benzenedicarboxamide.
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 rule has
been exempted from review under
Executive Order 12866, this 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 tolerances 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,
VerDate Aug<31>2005
15:55 Aug 12, 2008
Jkt 214001
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 rule. In addition, this 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: August 1, 2008.
Debra Edwards,
Director, 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 180.639 is added to read as
follows:
I
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
§ 180.639 Flubendiamide; tolerances for
residues.
(a) General. Tolerances are
established for residues of the
insecticide flubendiamide per se, N2[1,1-Dimethyl-2-(methylsulfonyl)ethyl3-iodo-N1-[2-methyl-4-[1,2,2,2tetrafluoro-1(trifluoromethyl)ethyl]phenyl]-1,2benzenedicarboxamide, in or on the
following food commodities:
Commodity
Almond, hulls ..................
Apple, wet pomace .........
Brassica, head and stem,
subgroup 5A ................
Brassica, leafy greens,
subgroup 5B ................
Cattle, fat ........................
Cattle, kidney ..................
Cattle, liver ......................
Cattle, muscle .................
Corn, field, forage ...........
Corn, field, grain .............
Corn, field, stover ...........
Corn, pop, grain ..............
Corn, pop, stover ............
Corn, sweet, forage ........
Corn, sweet, kernel plus
cob with husks removed .........................
Corn, sweet, stover ........
Cotton, gin byproducts ...
Cotton, undelinted seed
Egg .................................
Fruit, pome, group 11 .....
Fruit, stone, group 12 .....
Goat, fat ..........................
Goat, kidney ...................
Goat, liver .......................
Goat, muscle ..................
Grain, aspirated fractions
Grape ..............................
Horse, fat ........................
Horse, kidney ..................
Horse, liver .....................
Horse, muscle .................
Milk .................................
Milk, fat ...........................
Nut, tree, group 14 .........
Okra ................................
Poultry, fat ......................
Poultry, liver ....................
Poultry, muscle ...............
Sheep, fat .......................
Sheep, kidney .................
Sheep, liver .....................
Sheep, muscle ................
Vegetable, cucurbit,
group 9 ........................
Vegetable, fruiting, group
8 ..................................
Vegetable, leafy, except
Brassica, group 4 ........
Parts per million
9.0 ppm
2.0 ppm
0.60 ppm
5.0
0.30
0.30
0.30
0.05
8.0
0.02
15
0.02
15
9.0
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
0.01
25
60
0.90
0.01
0.70
1.6
0.30
0.30
0.30
0.05
5.0
1.4
0.30
0.30
0.30
0.05
0.04
0.30
0.06
0.30
0.02
0.01
0.01
0.30
0.30
0.30
0.05
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
0.20 ppm
0.60 ppm
11 ppm
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
Tolerances are established for the
indirect or inadvertent residues of the
E:\FR\FM\13AUR1.SGM
13AUR1
Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations
insecticide flubendiamide per se, N2[1,1-Dimethyl-2-(methylsulfonyl)ethyl3-iodo-N1-[2-methyl-4-[1,2,2,2tetrafluoro-1(trifluoromethyl)ethyl]phenyl]-1,2benzenedicarboxamide, in or on the
following raw agricultural commodities
when present therein as a result of the
application of flubendiamide per se to
the growing crops listed in paragraph (a)
of this section:
40 CFR Part 180
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–2007–0565. 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 either 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:
(703) 305–5704; e-mail address:
walters.vickie@epa.gov.
[EPA–HQ–OPP–2007–0565; FRL–8374–5]
SUPPLEMENTARY INFORMATION:
Tribenuron Methyl; Pesticide
Tolerances
I. General Information
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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).
Commodity
Parts per million
Alfalfa, forage .................
Alfalfa, hay ......................
Barley, hay ......................
Barley, straw ...................
Buckwheat ......................
Clover, forage .................
Clover, hay .....................
Grass, forage ..................
Grass, hay ......................
Millet, pearl, forage .........
Millet, pearl, hay .............
Millet, proso, forage ........
Millet, proso, hay ............
Millet, proso, straw .........
Oats, forage ....................
Oats, hay ........................
Oats, straw .....................
Rye, forage .....................
Rye, straw .......................
Sorghum, grain, forage ...
Sorghum, grain, stover ...
Soybean, forage .............
Soybean, hay ..................
Teosinte, forage ..............
Teosinte, hay ..................
Teosinte, straw ...............
Triticale, forage ...............
Triticale, hay ...................
Triticale, straw ................
Wheat, forage .................
Wheat, hay .....................
Wheat, straw ...................
0.15
0.04
0.04
0.07
0.07
0.15
0.04
0.15
0.04
0.15
0.04
0.15
0.04
0.07
0.15
0.04
0.07
0.15
0.07
0.03
0.06
0.02
0.04
0.15
0.04
0.07
0.15
0.04
0.07
0.15
0.03
0.03
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
[FR Doc. E8–18324 Filed 8–12–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
A. Does this Action Apply to Me?
hsrobinson on PROD1PC76 with RULES
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of tribenuron
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
(FFDCA).
VerDate Aug<31>2005
15:55 Aug 12, 2008
Jkt 214001
DATES:
PO 00000
Frm 00037
Fmt 4700
Sfmt 4700
47063
• 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–2007–0565 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–2007–0565, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
E:\FR\FM\13AUR1.SGM
13AUR1
Agencies
[Federal Register Volume 73, Number 157 (Wednesday, August 13, 2008)]
[Rules and Regulations]
[Pages 47057-47063]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18324]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0099; FRL-8360-2]
Flubendiamide; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of the
insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide,
in or on certain food and raw agricultural commodities. Bayer
CropScience, LP in c/o Nichino America, Inc. (U.S. subsidiary of Nihon
Nohyaku Co., Ltd.) requested these tolerances under the Federal Food,
Drug and Cosmetic Act (FFDCA).
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-2007-0099. 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
Room S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA 22202-4501. 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: Carmen Rodia, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone
number: (703) 306-0327; e-mail address: rodia.carmen@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. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at https://www.epa.gpo/opptsfrs/home/guidelin.htm.
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-2007-0099 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
[[Page 47058]]
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-2007-0099, 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
Avenue, NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Room S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA 22202-4501. 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 February 28, 2007 (72 FR 9000) (FRL-
8115-2), 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
6F7065) by Bayer CropScience, LP in c/o Nichino America, Inc. (U.S.
subsidiary of Nihon Nohyaku Co., Ltd.), P.O. Box 12014, Research
Triangle Park, NC 27709-2014. The petition requested that 40 CFR part
180 be amended by establishing permanent tolerances in primary crops
for residues of the insecticide flubendiamide, N2-[1,1-
Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-
[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-
benzenedicarboxamide, in or on the following raw agricultural and
processed commodities: Almond, hulls at 9.0 parts per million (ppm);
brassica, head and stem subgroup at 0.60 ppm; brassica, leafy greens
subgroup at 6.0 ppm; corn, field, forage at 8.0 ppm; corn, corn, field,
grain at 0.02 ppm; field, stover at 15.0 ppm; corn, pop, grain at 0.02
ppm; corn, pop, stover at 15.0 ppm; corn, sweet, forage at 9.0 ppm;
corn, sweet, kernel plus cob with husks removed at 0.02 ppm; corn,
sweet, stover at 25.0 ppm; cottonseed at 2.0 ppm; cotton, gin byproduct
at 60.0 ppm; fruit, pome group at 0.7 ppm; fruit, stone group at 1.6
ppm; grape at 1.4 ppm; nut, tree group at 0.06 ppm; okra at 0.30 ppm;
vegetable, cucurbit group at 0.20 ppm; vegetable, fruiting group at
0.30 ppm and vegetable, leafy, except brassica at 11.0 ppm; in or on
the following rotational crop commodities: Alfalfa, forage at 0.15 ppm;
alfalfa, hay at 0.04 ppm; barley, hay at 0.04 ppm; barley, straw at
0.07 ppm; buckwheat at 0.07 ppm; clover, forage at 0.15 ppm; clover,
hay at 0.04 ppm; grass, forage at 0.15 ppm; grass, hay at 0.04 ppm;
grass, silage at 0.27 ppm; millet, pearl, forage at 0.15 ppm; millet,
pearl hay at 0.04 ppm; millet, proso, forage at 0.15 ppm; millet,
proso, hay at 0.04 ppm; millet, proso, straw at 0.07 ppm; oats, forage
at 0.15 ppm; oats, hay at 0.04 ppm; oats, straw at 0.07 ppm; rye,
forage at 0.15 ppm; rye, straw at 0.07 ppm; sorghum, grain, forage at
0.03 ppm; sorghum, grain, stover at 0.06 ppm; soybean, forage at 0.02
ppm; soybean, hay at 0.04 ppm; teosinte, forage at 0.15 ppm; teosinte,
hay at 0.04 ppm; teosinte, straw at 0.07 ppm; triticale, forage at 0.15
ppm; triticale, hay at 0.04 ppm; triticale, straw at 0.07 ppm; wheat,
forage at 0.15 ppm; wheat, hay at 0.03 ppm and wheat, straw at 0.03
ppm; and in the following livestock commodities: Cattle, fat at 0.80
ppm; cattle, kidney at 0.60 ppm; cattle, liver at 0.60 ppm; cattle,
muscle at 0.10 ppm; eggs at 0.03 ppm; goat, fat at 0.80 ppm; goat,
kidney at 0.60 ppm; goat, liver at 0.60 ppm; goat, muscle at 0.10 ppm;
hog, fat at 0.80 ppm; hog, kidney at 0.60 ppm; hog, liver at 0.60 ppm;
hog, muscle at 0.10 ppm; horse, fat at 0.80 ppm; horse, kidney at 0.60
ppm; horse, liver at 0.60 ppm; horse, muscle at 0.10 ppm; milk at 0.20
ppm; poultry, fat at 0.08 ppm; poultry, liver at 0.03 ppm; poultry,
muscle at 0.01 ppm; sheep, fat at 0.80 ppm; sheep, kidney at 0.60 ppm;
sheep, liver at 0.60 ppm; and sheep, muscle at 0.10 ppm. That notice
referenced a summary of the petition prepared by Bayer CropScience, LP
in c/o Nichino America, Inc. (U.S. subsidiary of Nihon Nohyaku Co.,
Ltd.), the registrant, which is available to the public in the docket,
https://www.regulations.gov. There were no comments received in response
to the notice of filing.
Based upon review of the data supporting this petition and EPA
policy, the Agency has revised commodity definitions and/or some of the
proposed tolerances and concludes that the establishment of the
following tolerance is appropriate for the insecticide flubendiamide
per se in or on the following food commodities: Almond, hulls at 9.0
ppm; apple, wet pomace at 2.0 ppm; brassica, head and stem, subgroup 5A
at 0.60 ppm; brassica, leafy greens, subgroup 5B at 5.0 ppm; cattle,
fat at 0.30 ppm; cattle, kidney at 0.30 ppm; cattle, liver at 0.30 ppm;
cattle, muscle at 0.05 ppm; corn, field, forage at 8.0 ppm; corn,
field, grain at 0.02 ppm; corn, field, stover at 15 ppm; corn, pop,
grain at 0.02 ppm; corn, pop, stover at 15 ppm; corn, sweet, forage at
9.0 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm;
corn, sweet, stover at 25 ppm; cotton gin byproducts at 60 ppm; cotton,
undelinted seed at 0.90 ppm; egg at 0.01 ppm; fruit, pome, group 11 at
0.70 ppm; fruit, stone, group 12 at 1.6 ppm; goat, fat at 0.30 ppm;
goat, kidney at 0.30 ppm; goat, liver at 0.30 ppm; goat, muscle at 0.05
ppm; grain, aspirated fractions at 5.0 ppm; grape at 1.4 ppm; horse,
fat at 0.30 ppm; horse, kidney at 0.30 ppm; horse, liver at 0.30 ppm;
horse, muscle at 0.05 ppm; milk at 0.04 ppm; milk, fat at 0.30 ppm;
nut, tree, group 14 at 0.06 ppm; okra at 0.30 ppm; poultry, fat at 0.02
ppm; poultry, liver at 0.01 ppm; poultry, muscle at 0.01 ppm; sheep,
fat at 0.30 ppm; sheep, kidney at 0.30 ppm; sheep, liver at 0.30 ppm;
sheep, muscle at 0.05 ppm; vegetable, cucurbit, group 9 at 0.20 ppm;
vegetable, fruiting, group 8 at 0.60 ppm and vegetable, leafy, except
brassica, group 4 at 11 ppm; and in or on the following raw
agricultural commodities: Alfalfa, forage at 0.15 ppm; alfalfa, hay at
0.04 ppm; barley, hay at 0.04 ppm; barley, straw at 0.07 ppm; buckwheat
at 0.07 ppm; clover, forage at 0.15 ppm; clover, hay at 0.04 ppm;
grass, forage at 0.15 ppm; grass, hay at 0.04 ppm; millet, pearl,
forage at 0.15 ppm; millet, pearl, hay at 0.04 ppm; millet, proso,
forage at 0.15 ppm; millet, proso, hay at 0.04 ppm; millet, proso,
straw at 0.07 ppm; oats, forage at 0.15 ppm; oats, hay at 0.04 ppm;
oats, straw at 0.07 ppm; rye, forage at 0.15 ppm; rye, straw at 0.07
ppm; sorghum, grain, forage at 0.03 ppm; sorghum, grain, stover at 0.06
ppm; soybean, forage at 0.02 ppm; soybean, hay at 0.04 ppm; teosinte,
forage at 0.15 ppm; teosinte, hay at 0.04 ppm; teosinte, straw at 0.07
ppm; triticale, forage at 0.15 ppm; triticale, hay at 0.04 ppm;
triticale, straw at 0.07 ppm; wheat, forage at 0.15 ppm; wheat, hay at
0.03 ppm and wheat, straw at 0.03 ppm.
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
[[Page 47059]]
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 submitted 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 the insecticide
flubendiamide. 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.
Flubendiamide has low acute toxicity via the oral and dermal
routes, is only a slight eye irritant, is non-irritating to the dermis
and tests negative for skin sensitization. In the longer-term studies
in the flubendiamide mammalian toxicology database, the primary target
organs identified were the liver, thyroid, kidney and eyes. Liver
effects reported in rats, mice and/or dogs include organ weight
increase, periportal fatty change, hypertrophy and minimal foci of
cellular alteration. Thyroid effects include organ weight increase,
follicular cell hypertrophy and slight perturbations of
triiodothyronine (TC) and thyroid stimulating hormone (TSH) in the rat
and mouse. Kidney effects include increases in absolute and/or relative
to body kidney weights and chronic nephropathy in the rat. Eye effects
include eye enlargement, opacity and exophthalmus with hemorrhage and
appear only in rat pups. Other changes include mild microcytic anemia,
decreased serum triglycerides and cholesterol in female rat, increased
gamma glutamyl peptidase, alkaline phosphatase and shortened activated
prothrombin time in dogs, and adrenal weight increase and an increase
in adrenal cortical cell hypertrophy in dogs.
The hazard assessment indicated potential toxicity resulting from
exposure to flubendiamide via different routes over different
durations. The observed eye effects were selected as a critical effect
for the acute dietary exposure scenario; whereas liver and thyroid
effects were determined critical for the chronic dietary exposure
scenario. Short-term and intermediate-term dermal risks were also based
on liver and thyroid effects as well as blood effects. Short-term and
intermediate-term inhalation risks are based on liver toxicity as well
as adrenal weight increase and an increase in adrenal cortical cell
hypertrophy.
There was no evidence of carcinogenicity in rats and mice up to the
limit dose at 24- and 18-months, respectively. Flubendiamide was
determined to be non-mutagenic in bacteria, negative in an in vivo
mammalian cytogenetics assay and did not cause unscheduled DNA
synthesis (repair of DNA damage) in mammalian cells in vitro. Overall,
there was no clear evidence that flubendiamide was either mutagenic or
clastogenic in either in vivo or in vitro assays. The cancer
classification is ``Not Likely to be Carcinogenic to Humans.''
More detailed information on the studies received and the nature of
the adverse effects caused by flubendiamide 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 in the document
entitled, ``Flubendiamide: Human Health Risk Assessment for Proposed
Uses on Corn, Cotton, Tobacco, Tree fruit, Tree nuts, Vine crops and
Vegetable crops,'' dated April 3, 2008, by going to https://
www.regulations.gov. The referenced document is available in the docket
established by this action, which is described under ADDRESSES, and is
identified as EPA-HQ-OPP-2007-0099-0005 in that docket. Locate and
click on the hyperlink for docket ID number EPA-HQ-OPP-2007-0099.
Double-click on the document to view the referenced information on
pages 65-70 of 105.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-term and chronic-term risks are evaluated by comparing
food, water and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, refer to https://
www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for flubendiamide used for
human risk assessment can be found in the document entitled,
``Flubendiamide: Human Health Risk Assessment for Proposed Uses on
Corn, Cotton, Tobacco, Tree fruit, Tree nuts, Vine crops and Vegetable
crops,'' dated April 3, 2008, by going to https://www.regulations.gov.
The referenced document is available in the docket established by this
action, which is described under ADDRESSES, and is identified as EPA-
HQ-OPP-2007-0099-0005 in that docket. Locate and click on the hyperlink
for docket ID number EPA-HQ-OPP-2007-0099. Double-click on the document
to view the referenced information on pages 37-38 of 105.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flubendiamide, EPA considered exposure under the
[[Page 47060]]
petitioned-for tolerances and assessed dietary exposures from
flubendiamide 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 Dietary
Exposure Evaluation Model-Food Commodity Intake Database (DEEM-
FCID\TM\, Version 2.03), which incorporates food consumption data from
the U.S. Department of Agriculture's (USDA's) Nationwide Continuing
Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.
The acute assessments assumed that 100% of crops with requested uses of
flubendiamide are treated and that all treated crops contain residues
at tolerance-level. In addition, tolerance-level residues for livestock
commodities were included in these analyses to account for the
potential transfer of plant residues to livestock tissues.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used DEEM-FCID\TM\, Version 2.03, which incorporates
food consumption data from the USDA's CSFII from 1994-1996 and 1998.
The chronic assessments assumed that 100% of crops with requested uses
of flubendiamide are treated and that all treated crops contain
residues at the average residue levels found in the crop field trials
and experimentally-determined processing factors where available. In
addition, average-level residues for livestock commodities were also
included in these analyses to account for the potential transfer of
plant residues to livestock tissues.
iii. Cancer. As explained in Unit III.A., flubendiamide is
considered to be ``Not Likely to be Carcinogenic to Humans.'' As a
result, cancer exposure assessment is not needed for flubendiamide.
iv. Anticipated residue 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.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flubendiamide in drinking water. These simulation models
take into account data on the physical, chemical and fate/transport
characteristics of flubendiamide.
Flubendiamide is persistent and potentially mobile in terrestrial
and aquatic environments. These fate properties suggest that it has a
potential to move into surface and ground water. The Agency lacks
sufficient monitoring exposure data for use in risk assessments, as
flubendiamide is a new active ingredient. Because the Agency does not
have comprehensive monitoring data, drinking water concentration
estimates are made by reliance on simulation or modeling, taking into
account data on the physical and fate characteristics of flubendiamide.
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 the Screening Concentration in Ground Water
(SCI-GROW) model, the estimated drinking water concerns (EDWCs) of
flubendiamide for acute exposures are estimated to be 12.93 parts per
billion (ppb) for surface water and 0.06 ppb for ground water. For
chronic exposures for non-cancer assessments, the EDWCs are estimated
to be 11.95 ppb for surface water and 0.06 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 12.93 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 11.95 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). Flubendiamide is not
registered for any specific use patterns that would result in
residential exposure. That is, no residential uses are being requested
for flubendiamide at this time; therefore, no residential risk
assessment has been conducted.
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.''
EPA has not found flubendiamide to share a common mechanism of
toxicity with any other substances, and flubendiamide does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action; therefore, EPA has assumed that
flubendiamide does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional ten-fold (10x) margin of safety for infants
and children in the case of threshold effects to account for pre-natal
and/or post-natal toxicity, and the completeness of the database on
toxicity and exposure, unless EPA determines based on reliable data
that a different margin of safety will be safe for infants and
children. This additional margin of safety is commonly referred to as
the Food Quality Protection Act Safety Factor (FQPA SF). In applying
this provision, EPA either retains the default value of 10x or uses a
different additional SF when reliable data available to EPA support the
choice of a different factor.
2. Pre-natal and post-natal sensitivity. While both the rat and
rabbit developmental studies did not identify teratogenic effects and
showed no evidence of increased pre-natal susceptibility, adverse eye
effects (eye enlargement) were noted in post-natal rat pups older than
14 days in multiple studies (the 2-generation reproduction and 1-
generation supplemental studies) and the developmental neurotoxicity
(DNT) study reported eye effects appearing in some offspring between
lactation days 14 and 42, even though exposure stopped at lactation day
21, indicating a possible delay (a latent response) from the time of
last exposure to onset of bupthalmos. These eye
[[Page 47061]]
effects did not occur in adult rats. Since the iris and chamber angle
are differentiating and specializing into definite structures during
post-natal days 5-20, neonatal rats appear to have an increased
susceptibility to flubendiamide exposure as compared to adults. The DNT
study also reported that pre-mating exposures are not required to
elicit the eye effect in pups. In addition to the reported eye effects
in the DNT study, there was also a balano-preputial separation
(separation of the prepuce (foreskin) from the glans penis (balanus))
delay. While these effects are considered adverse, they are not assumed
to be developmental effects from in utero exposure. Even though the
delay in balanopreputial separation may be a result of post-natal
exposure (sensitivity of the young), and the effect is adverse, it is
considered reversible and not an indication of perinatal sensitivity/
susceptibility.
Human microsomes have been shown to be capable of approximately 4
times higher hydroxylation rates of flubendiamide as compared to female
mouse microsomes and may be able to efficiently metabolize and excrete
flubendiamide, preventing accumulation of the parent compound. It
remains unclear whether the ability to metabolize and clear the parent
compound is the only requirement to avoid ocular toxicity. Due to the
potential concern for increased susceptibility of the human neonate as
compared to adults, this perinatal ocular effect is considered in the
human health risk assessment for flubendiamide.
3. Conclusion. EPA evaluated the quality of the toxicity and
exposure data and, based on these data, has determined that the safety
of infants and children would be adequately protected if the FQPA SF
were reduced to 1x. That decision is based on the following findings:
i. The toxicology database for flubendiamide is complete for
purposes of this risk assessment and the characterization of potential
pre-natal and/or post-natal risks to infants and children. Although
susceptibility was identified in the toxicological database (eye
effects), the selected regulatory PODs (which are based on clear
NOAELs) are protective of these effects; therefore, the human health
risk assessment is protective.
ii. There are no treatment-related neurotoxic findings in the acute
neurotoxicity and DNT studies in rats; although eye effects were
observed in the DNT study. As noted in the previous paragraph, the PODs
employed in the risk assessment are protective of this effect.
iii. There are no residual uncertainties identified in the exposure
databases and the exposure assessment is protective. The acute dietary
food exposure assessment utilizes tolerance-level residues, the chronic
dietary food exposure assessment utilizes average residue levels found
in the crop field trials/livestock commodities and both assume 100% of
crops with requested uses of flubendiamide are treated. The drinking
water assessment generated EDWCs using models and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations. The highest
relevant EDWCs were used in the dietary (food and drinking water)
exposure assessment. By using these screening-level exposure
assessments in the acute and chronic dietary (food and drinking water)
assessments, risk is not underestimated for flubendiamide.
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-term, intermediate-term 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.
For flubendiamide, there is potential exposure from food and
drinking water, but not from residential use sites (as there are no
proposed residential uses for flubendiamide). Since hazard was
identified via the oral route over both the acute and chronic duration,
the aggregate risk assessment considers exposures from food and
drinking water consumed over the acute and chronic durations.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flubendiamide will occupy less than 8% of the aPAD for the mostly
highly exposed population subgroup, children aged 1-2 years old.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flubendiamide from food and water will utilize less than 15% of the
cPAD for the mostly highly exposed population subgroup, children aged
1-2 years old. There are no residential uses for flubendiamide.
3. Aggregate cancer risk for U.S. population. Flubendiamide has
been classified as ``Not Likely to be Carcinogenic to Humans'' and is
not expected to pose a cancer risk.
4. 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 flubendiamide residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (LC/MS/MS, Methods 00816/M002 and
00912) is available to enforce the tolerance expression. The method may
be requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Road, Fort Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are currently no established CODEX, Canadian or Mexican
maximum residue limits (MRLs) for residues of flubendiamide in or on
various crop or livestock commodities.
C. Revisions to Petitioned-For Tolerances
Based upon review of the data submitted in support of this
tolerance petition for flubendiamide and EPA policy, the Agency has
revised commodity definitions and/or some of the proposed tolerances.
No residue data were submitted to support the proposed uses on okra and
popcorn. The available field trial data for fruiting vegetables may be
translated to okra, and the submitted data for field corn may also be
translated to popcorn. The proposed uses on all types of corn (field,
pop and sweet) are identical.
Parent residue levels vary based on crop (for edible commodities,
residues ranging from 0.018 ppm, corn, field, grain to 6.7 ppm,
spinach). Most crops indicated parent residues declined with successive
sampling dates and were determined to be available on the surface of
plants/RACs. The Agency will allow translation of residue data from
trials conducted on rotated barley, sorghum and wheat to support the
proposed rotational crop tolerances for the forages, hay and straw of
other types of cereal grains and grasses. The Agency
[[Page 47062]]
will also allow translation of residue data from trials conducted on
rotated soybean to support the proposed rotational crop tolerances for
the forages, fodder, hay and straw on alfalfa and clover to support the
rotational plant-back intervals. Based on the transfer coefficients for
livestock tissues and the relatively low dietary burden for swine of
0.02 ppm for flubendiamide, tolerances for hogs are not needed.
V. Conclusion
Therefore, tolerances are established forresidues of the
insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide.
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 rule has been
exempted from review under Executive Order 12866, this 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 tolerances 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 rule. In addition, this 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: August 1, 2008.
Debra Edwards,
Director, 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 180.639 is added to read as follows:
Sec. 180.639 Flubendiamide; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide,
in or on the following food commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond, hulls........................................ 9.0 ppm
Apple, wet pomace.................................... 2.0 ppm
Brassica, head and stem, subgroup 5A................. 0.60 ppm
Brassica, leafy greens, subgroup 5B.................. 5.0 ppm
Cattle, fat.......................................... 0.30 ppm
Cattle, kidney....................................... 0.30 ppm
Cattle, liver........................................ 0.30 ppm
Cattle, muscle....................................... 0.05 ppm
Corn, field, forage.................................. 8.0 ppm
Corn, field, grain................................... 0.02 ppm
Corn, field, stover.................................. 15 ppm
Corn, pop, grain..................................... 0.02 ppm
Corn, pop, stover.................................... 15 ppm
Corn, sweet, forage.................................. 9.0 ppm
Corn, sweet, kernel plus cob with husks removed...... 0.01 ppm
Corn, sweet, stover.................................. 25 ppm
Cotton, gin byproducts............................... 60 ppm
Cotton, undelinted seed.............................. 0.90 ppm
Egg.................................................. 0.01 ppm
Fruit, pome, group 11................................ 0.70 ppm
Fruit, stone, group 12............................... 1.6 ppm
Goat, fat............................................ 0.30 ppm
Goat, kidney......................................... 0.30 ppm
Goat, liver.......................................... 0.30 ppm
Goat, muscle......................................... 0.05 ppm
Grain, aspirated fractions........................... 5.0 ppm
Grape................................................ 1.4 ppm
Horse, fat........................................... 0.30 ppm
Horse, kidney........................................ 0.30 ppm
Horse, liver......................................... 0.30 ppm
Horse, muscle........................................ 0.05 ppm
Milk................................................. 0.04 ppm
Milk, fat............................................ 0.30 ppm
Nut, tree, group 14.................................. 0.06 ppm
Okra................................................. 0.30 ppm
Poultry, fat......................................... 0.02 ppm
Poultry, liver....................................... 0.01 ppm
Poultry, muscle...................................... 0.01 ppm
Sheep, fat........................................... 0.30 ppm
Sheep, kidney........................................ 0.30 ppm
Sheep, liver......................................... 0.30 ppm
Sheep, muscle........................................ 0.05 ppm
Vegetable, cucurbit, group 9......................... 0.20 ppm
Vegetable, fruiting, group 8......................... 0.60 ppm
Vegetable, leafy, except Brassica, group 4........... 11 ppm
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. Tolerances are established
for the indirect or inadvertent residues of the
[[Page 47063]]
insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide,
in or on the following raw agricultural commodities when present
therein as a result of the application of flubendiamide per se to the
growing crops listed in paragraph (a) of this section:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Alfalfa, forage...................................... 0.15 ppm
Alfalfa, hay......................................... 0.04 ppm
Barley, hay.......................................... 0.04 ppm
Barley, straw........................................ 0.07 ppm
Buckwheat............................................ 0.07 ppm
Clover, forage....................................... 0.15 ppm
Clover, hay.......................................... 0.04 ppm
Grass, forage........................................ 0.15 ppm
Grass, hay........................................... 0.04 ppm
Millet, pearl, forage................................ 0.15 ppm
Millet, pearl, hay................................... 0.04 ppm
Millet, proso, forage................................ 0.15 ppm
Millet, proso, hay................................... 0.04 ppm
Millet, proso, straw................................. 0.07 ppm
Oats, forage......................................... 0.15 ppm
Oats, hay............................................ 0.04 ppm
Oats, straw.......................................... 0.07 ppm
Rye, forage.......................................... 0.15 ppm
Rye, straw........................................... 0.07 ppm
Sorghum, grain, forage............................... 0.03 ppm
Sorghum, grain, stover............................... 0.06 ppm
Soybean, forage...................................... 0.02 ppm
Soybean, hay......................................... 0.04 ppm
Teosinte, forage..................................... 0.15 ppm
Teosinte, hay........................................ 0.04 ppm
Teosinte, straw...................................... 0.07 ppm
Triticale, forage.................................... 0.15 ppm
Triticale, hay....................................... 0.04 ppm
Triticale, straw..................................... 0.07 ppm
Wheat, forage........................................ 0.15 ppm
Wheat, hay........................................... 0.03 ppm
Wheat, straw......................................... 0.03 ppm
------------------------------------------------------------------------
[FR Doc. E8-18324 Filed 8-12-08; 8:45 am]
BILLING CODE 6560-50-S