Cyfluthrin; Pesticide Tolerance, 10390-10396 [E8-3393]
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EPA-APPROVED REGULATIONS IN THE TEXAS SIP—Continued
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[FR Doc. E8–3380 Filed 2–26–08; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0857; FRL–8350–3]
Cyfluthrin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
ebenthall on PRODPC61 with RULES
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of cyfluthrin in
or on grass, forage, fodder and hay
group 17, forage at 12 ppm; grass,
forage, fodder and hay, group 17, hay at
50 ppm; beet, sugar, roots at 0.10 ppm;
and beet, sugar, dried pulp at 1.0 ppm.
Interregional Research Project Number 4
(IR-4), and Bayer CropScience requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
February 27, 2008. Objections and
requests for hearings must be received
on or before April 28, 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–2006–0857. To access the
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05/22/97, 62 FR 27964.
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09/06/06, 71 FR 52698.
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FOR FURTHER INFORMATION CONTACT:
Shaja R. Brothers, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–3194; e-mail address:
brothers.shaja@epa.gov.
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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 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.
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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),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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
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the person listed under FOR FURTHER
INFORMATION CONTACT.
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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–2006–0857 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before April 28, 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–2006–0857, 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 Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’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
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deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Registers of October
27, 2006 (71 FR 63011) (FRL–8100–2),
and May 9, 2007 (72 FR 26372) (FRL–
8121–5) EPA issued notices pursuant to
section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
pesticide petitions (PP) 6E7058 by IR-4,
500 College Road East, Suite 201 W,
Princeton, NJ, 08540; and (PP) 6F7160
by Bayer CropScience, 2.T.W.
Alexander Drive, PO Box 12014,
Research Triangle Park, NC 27709. The
petitions requested that 40 CFR 180.436
be amended by establishing tolerances
for residues of the insecticide
cyfluthrin, cyano(4-fluoro-3-pheno
xyphenyl)methyl 3-(2,2dichloroethenyl)-2,2-dimethylcyclo
propanecarboxylate, in or on grass,
forage at 15 parts per million (ppm) (PP
6E7058); grass, hay at 40 ppm (PP
6E7058); beet, sugar, roots at 0.09 ppm
(PP 6F7160); and beet, sugar, dried pulp
at 11 ppm (PP 6F7160). The notices
referenced a summary of the petition
prepared by Bayer CropScience, the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. Comments were
received from a private citizen on the
notices of filing concerning the
tolerances for grass, forage; grass, hay;
beet, sugar, roots; and beet, sugar, dried
pulp. EPA’s response to these comments
is discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA has revised
the commodity and/or tolerance
expressions for the proposed petitions.
The reason for these changes is
explained in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
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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....’’ These provisions
were added to FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerance for residues of cyfluthrin on
grass, forage, fodder and hay, group 17,
forage at 12 ppm; grass, forage, fodder
and hay, group 17, hay at 50 ppm; beet,
sugar, roots at 0.10 ppm; and beet,
sugar, dried pulp at 1.0 ppm. EPA’s
assessment of exposures and risks
associated with establishing the
tolerance 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.
Toxicologically, the primary target for
cyfluthrin/beta-cyfluthrin is the
neuromuscular system; other nonspecific effects include decreased body
weight gain, and decreased food
consumption. The observed
neuromuscular effects (tremors, gait
abnormities, abnormal postural
reactions, splaying of limbs and
decreases in activity) occurred mainly
in oral studies in the dog and the rat. In
general, the toxicity data base does not
indicate that any major differences in
toxicity exist between beta-cyfluthrin
and cyfluthrin via the oral route. Data
from the inhalation toxicity study
showed evidence of clinical signs as
well as hypothermia and decreased
body weight gains. In a postnatal
inhalation study in mice, there were
clinical signs of neurotoxicity in the
pups as well as increased spontaneous
motor activity and paresthesia (tingling,
burning or prickling – also seen in oral
studies).
In oral developmental studies no
increased susceptibility was observed in
the rat or rabbit; however, increased
susceptibility was observed in
inhalation developmental studies.
Increased susceptibility was also seen in
oral reproduction studies and in a
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developmental neurotoxicity study on
beta-cyfluthrin. The data also
demonstrate increased susceptibility of
rats and mice to cyfluthrin postnatally.
The database does not indicate that
either cyfluthrin or beta-cyfluthrin
induces any endocrine disruption; and,
there is no concern of mutagenicity.
EPA has classified cyfluthrin/betacyfluthrin as ‘‘not likely to be
carcinogenic to humans.’’
Specific information on the studies
received and the nature of the adverse
effects caused by cyfluthrin as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found in the
Cyfluthrin: Human Health Risk
Assessment for New Uses on Grasses,
Alfalfa, and Sugar Beet Seed and
Revised Tolerances on Cereal Grain
Commodities on pages 54–64 at
www.regulations.gov. The referenced
document is available in docket EPA–
HQ–OPP–2006–0857.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the toxicological level of concern
(LOC) is derived from 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) is sometimes
used for risk assessment. Uncertainty/
safety factors (UFs) are used in
conjunction with the LOC 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 risks by comparing
aggregate 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 LOC by all
applicable UFs. Short-, intermediate-,
and long-term risks are evaluated by
comparing aggregate exposure to the
LOC to ensure that the margin of
exposure (MOE) called for by the
product of all applicable UFs is not
exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of occurrence of additional adverse
cases. Generally, cancer risks are
considered non-threshold. For more
information on the general principles
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EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
A summary of the toxicological
endpoints for cyfluthrin used for human
risk assessmentcan be found at https://
www.regulations.gov in the Cyfluthrin:
Human Health Risk Assessment for New
Uses of Grasses, Alfalfa, and Sugar Beet
Seed and Revised Tolerances on Cereal
Grain Commodities on pages 23 and 24
for docket ID number EPA–HQ–OPP–
2006–0857.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to cyfluthrin, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
cyfluthrin tolerances in (40 CFR
180.436). EPA assessed dietary
exposures from cyfluthrin 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 U.S. Department of
Agriculture (USDA) 1994–1996 and
1998 Nationwide Continuing Surveys of
Food Intakes by Individuals (CSFII). As
to residue levels in food, EPA’s analysis
was based on tolerance level residues,
crop field trial data, Pesticide Data
Program (PDP) monitoring data, percent
crop treated, anticipated residues in
animal commodities, and processing
factors.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA used the food
consumption data from the USDA 1994–
1996, and 1998 CSFII. As to residue
levels in food, EPA’s analysis was based
on tolerance level residues, crop field
trial data, PDP monitoring data, average
percent crop treated, anticipated
residues in animal commodities, and
processing factors.
iii. Cancer. A cancer dietary exposure
analysis was not performed because
EPA has classified cyfluthrin as being
‘‘not likely to cause cancer in humans.’’
iv. Anticipated residue and percent
crop treated (PCT) 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 pursuant to
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FFDCA section 408(f)(1) require 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 this tolerance.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if:
a. The data used are reliable and
provide a valid basis to show what
percentage of the food derived from
such crop is likely to contain such
pesticide residue.
b. The exposure estimate does not
underestimate exposure for any
significant subpopulation group.
c. Data are available on pesticide use
and food consumption in a particular
area, the exposure estimate does not
understate exposure for the population
in such area. In addition, the Agency
must provide for periodic evaluation of
any estimates used. To provide for the
periodic evaluation of the estimate of
PCT as required by FFDCA section
408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used PCT information for
chronic dietary exposures as follows:
Almond 1%; cabbage 5%; cantaloupe
1%; field corn 5%; cotton 10%;
cucumber 1%; pecan 1%; pepper 10%;
potato 25%; pumpkin 1%; sorghum 1%;
soybean 1%; squash 5%; sugarcane 1%;
sunflower 1%; and watermelon 2.5%.
EPA uses an average PCT for the acute
and chronic dietary risk analysis. The
average PCT figure for each existing use
is derived by combining available
federal, state, and private market survey
data for that use, averaging by year,
averaging across all years, and rounding
up to the nearest multiple of 5% except
for those situations in which the average
PCT is less than one. In those cases <1%
is used as the average and <2.5% is used
as the maximum. EPA uses a maximum
PCT for acute dietary risk analysis. The
maximum PCT figure is the single
maximum value reported overall from
available Federal, State, and private
market survey data on the existing use,
across all years, and rounded up to the
nearest multiple of 5%. In most cases,
EPA uses available data from United
States Department of Agriculture/
National Agricultural Statistics Service
(USDA/NASS), Proprietary Market
Surveys, and the National Center for
Food and Agriculture Policy (NCFAP)
for the most recent 6 years.
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The Agency used projected PCT
information for chronic dietary
exposures as follows:
Apple 69%; collard 22%; grape 15%;
kale 13%; mustard greens 7%; grass <1
%; peach 43%; pear 62%; plum 37%;
spinach 39%; turnip 14%, and wheat
2%.
EPA estimates an upper bound of
projected percent crop treated (PPCT)
for a new pesticide use by assuming that
the percent crop treated (PCT) during
the pesticide’s initial 5 years of use on
a specific crop will not exceed the
average PCT of the dominant pesticide
(i.e., the one with the greatest PCT) on
that crop over the three most recent
surveys. EPA calls this the market
leader PPCT estimate. The average
market leader PCTs may be based on
one or two survey years if three are not
available. Also, with limited availability
of data, the average market leader PCTs
may be based on a cross-section of state
PCTs. Comparisons are only made
initially among pesticides of the same
pesticide type (e.g., leading insecticides
on the crop compared with the new
insecticide), or, for more refined
estimates, comparisons may be made
among pesticides in a subcategory of the
same pesticide type (e.g., leading
pyrethroid insecticides compared with
the new pyrethroid insecticide). The
PCTs included in the average may be
each for the same pesticide or for
different pesticides since the same or
different pesticides may dominate each
year selected. Typically, EPA uses U.S.
Department of Agriculture/National
Agricultural Statistics Service (USDA/
NASS) as the source for raw PCT data
because it is publicly available. When a
specific crop is not surveyed by USDA/
NASS, EPA uses other sources
including proprietary data and
calculates the estimated PCT.
An estimated PPCT, based on the
average PCT of the market leaders, is
appropriate for use in chronic dietary
risk assessment. This method of
estimating PPCT for a new use of a
registered pesticide or a new pesticide
produces high-end estimate that is
unlikely, in most cases, to be exceeded
during the initial 5 years of actual use.
Predominant factors that bear on
whether the PPCT could be exceeded
may include PCTs of similar
chemistries, pests controlled by
alternatives, pest prevalence in the
market and other factors. All relevant
information currently available for
predominant factors has been
considered for the use of cyfluthrin on
apples, cabbage, cauliflower, collards,
grapes, kale, mustard greens, pasture/
rangeland, peaches, pears, peas, plums,
spinach, turnip greens, and wheat. It is
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unlikely that actual PCTs for cyfluthrin
will exceed the corresponding estimated
PPCTs during the next 5 years because
cyfluthrin shares many pest control
attributes and constraints with other
members of the pyrethroid class and
will likely replace or be used in a
similar manner to currently registered
pyrethroids.
The Agency believes that the three
conditions listed above have been met.
With respect to Condition a, PCT
estimates are derived from Federal and
private market survey data, which are
reliable and have a valid basis. The
Agency is reasonably certain that the
percentage of the food treated is not
likely to be an underestimation. As to
Conditions b and c, regional
consumption information and
consumption information for significant
subpopulations is taken into account
through EPA’s computer-based model
for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available information on the
regional consumption of food to which
cyfluthrin may be applied in a
particular area.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring data to complete a
comprehensive dietary exposure
analysis and risk assessment for
cyfluthrin in drinking water. 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 environmental fate characteristics of
cyfluthrin. 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 survey of all the currently
registered and proposed uses of
cyfluthrin, it was determined that
cyfluthrin use on alfalfa and cotton
would lead to the highest surface water
and ground water estimated
groundwater concentrations (EDWCs),
respectively. Based on the First Index
Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground
Water (SCI-GROW) models, the
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estimated environmental concentrations
(EECs) of cyfluthrin are estimated to be
3.677 parts per billion (ppb) and 0.155
ppb for acute and chronic exposure in
surface water respectively. The EEC for
chronic groundwater exposure is 0.457
ppb.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 3.677 ppb was
used to access the contribution of
residues in drinking water to dietary
risk. For chronic dietary risk
assessment, the water concentration of
value 0.457 ppb was used to access 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).
Cyfluthrin products are registered for
use at residential sites including indoor
(total release fogger, and crack and
crevice spray), and outdoor uses (spray
fogger, and lawn applications).
Residential exposure for adults was
assessed via the inhalation and dermal
routes, while exposure for infants and
children was assessed via inhalation,
dermal, and oral (hand-to-mouth)
routes. Exposure for outdoor handlers
was assessed via the Inhalation and
dermal routes. Residential applicator for
indoor total release fogger was not
assessed quantitatively, because indoor
inhalation exposure to a homeowner
would likely be less than inhalation
exposure to homeowner that would
result from outdoor lawn treatments.
Residential MOEs were assessed for
indoor and outdoor uses for application
and post-application exposures. This is
considered a conservative assessment
assuming the lawn and carpet uses
happen on the same day.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Cyfluthrin and beta-cyfluthrin are
members of the pyrethroid class of
pesticides. Although all pyrethroids
alter nerve function by modifying the
normal biochemistry and physiology of
nerve membrane sodium channels, EPA
is not currently following a cumulative
risk approach based on a common
mechanism of toxicity for the
pyrethroids. Although all pyrethroids
interact with sodium channels, there are
multiple types of sodium channels and
it is currently unknown whether the
pyrethroids have similar effects on all
channels. The Agency does not have a
clear understanding of effects on key
downstream neuronal function e.g.,
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ebenthall on PRODPC61 with RULES
nerve excitability, nor does the Agency
understand how these key events
interact to produce their compound
specific patterns of neurotoxicity. There
is ongoing research by EPA’s Office of
Research and Development and
pyrethroid registrants to evaluate the
differential biochemical and
physiological actions of pyrethroids in
mammals. When the results of the
research become available, the Agency
will consider the findings and make a
determination of common mechanism
as a basis for assessing cumulative risk.
Information regarding EPA’s procedures
for cumulating effects from substances
found to have a common mechanism
can be found on EPA’s website at https://
www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and
Children
1.In general. Section 408 of FFDCA
provides that EPA shall apply an
additional (‘‘10X’’) tenfold margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal 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
FQPA safety factor. In applying this
provision, EPA either retains the default
value of 10X when reliable data do not
support the choice of a different factor,
or, if reliable data are available, EPA
uses a different additional FQPA safety
factor value based on the use of
traditional UFs and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity.
There was no evidence of increased
susceptibility of rats or rabbits in utero
exposure in developmental oral studies;
however, there was some indication of
increased susceptibility in
developmental inhalation studies. A
clear NOAEL was established for the
fetal effects in every case. No residual
uncertainties were identified.
The data also showed increased
susceptibility of rats and mice from
postnatal exposure to cyfluthrin. A clear
NOAEL was established for the
offspring effects in every case. No
residual uncertainties were identified.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
the FQPA safety factor to 1X. That
decision is based on the following
findings:
i. The toxicology databases for
cyfluthrin and beta-cyfluthrin together
are considered complete and adequate
for selecting toxicity endpoints for risk
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assessment. The toxicity profiles of both
cyfluthrin and beta-cyfluthrin can be
characterized for all effects, including
potential developmental, reproductive
and neurotoxic effects. Exposure data
are complete or are estimated based on
data that reasonably accounts for
potential exposures.
ii. There is no evidence of increased
susceptibility of rats or rabbits to in
utero exposure in developmental oral
studies, and the degree of concern for
the effects observed in the inhalation
developmental studies is considered
low since a clear NOAEL was
established for the fetal effects in every
case.
iii. The NOAEL used for short-term
inhalation exposure scenarios is
protective of the effects seen in the
developmental studies via the
inhalation route.
iv. The degree of concern for the
effects observed in the reproductive
studies was considered low since a clear
NOAEL was established for the
offspring effects in every case.
v. The NOAEL used to establish the
cPAD for all populations is protective of
the effects seen in the young in the
reproduction studies.
vi. A beta-cyfluthrin developmental
neurotoxicity study has been submitted
for review and indicated both the
LOAEL and NOAEL from this study are
higher than the LOAEL and NOAEL
chosen for risk assessment purposes.
vii. There are no residual
uncertainties identified in the exposure
databases. Although the acute and
chronic food exposure assessments are
refined, EPA believes that the
assessments are based on reliable data
and will not underestimate exposure/
risk. The drinking water estimates were
derived from conservative screening
models. The residential exposure
assessment utilizes reasonable high-end
variables set out in EPA’s Occupational/
Residential Exposure SOPs (Standard
Operating Procedures). The aggregate
assessment is based upon reasonable
worst-case residential assumptions, and
is also not likely to underestimate
exposure/risk to any subpopulation,
including those comprised of infants
and children.
E. Aggregate Risks and Determination of
Safety
Safety is assessed for acute and
chronic risks by comparing aggregate
exposure to the pesticide to the aPAD
and cPAD. The aPAD and cPAD are
calculated by dividing the LOC by all
applicable UFs. For linear cancer risks,
EPA calculates the probability of
additional cancer cases given aggregate
exposure. Short-, intermediate-, and
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Fmt 4700
Sfmt 4700
long-term risks are evaluated by
comparing aggregate exposure to the
LOC to ensure that the MOE called for
by the product of all applicable UFs is
not exceeded.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
cyfluthrin will occupy 53% of the aPAD
for the population group children 1 to
2 years old receiving the greatest
exposure. Therefore, EPA does not
expect the aggregate exposure to exceed
100% of the aPAD.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to cyfluthrin from food
and water will utilize 17% of the cPAD
for the population group children 1 to
2 years old receiving the greatest
exposure. Based on the use pattern,
chronic residential exposure to residues
of cyfluthrin is not expected. Therefore,
EPA does not expect the aggregate
exposure to exceed 100% of the cPAD.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Cyfluthrin is currently registered for
use(s) that could result in short-term
residential exposure and the Agency has
determined that it is appropriate to
aggregate chronic food and water and
short-term exposures for cyfluthrin.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded that
food, water, and residential exposures
aggregated result in aggregate MOEs of
320 for children 1 to 2 years old; 400 for
infants < 1 year old; and 420 for the U.S.
population. These aggregate MOEs do
not exceed the Agency’s level of
concern for aggregate exposure to food,
water and residential uses. Therefore,
EPA does not expect short-term
aggregate exposures to exceed the
Agency’s level of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Cyfluthrin is currently registered for
use(s) that could result in intermediateterm residential exposure and the
Agency has determined that it is
appropriate to aggregate chronic food
and water and intermediate-term
exposures for cyfluthrin. Using the
exposure assumptions described in this
unit for intermediate-term exposures,
EPA has concluded that food, water,
and residential exposures aggregated
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result in aggregate MOEs of 220 for the
U.S. population; 240 for infants < 1 year
old; and 230 for children 1 to 2 years
old. These aggregate MOEs do not
exceed the Agency’s level of concern for
aggregate exposure to food, water and
residential uses. Therefore, EPA does
not expect intermediate-term aggregate
exposures to exceed the Agency’s level
of concern.
5. Aggregate cancer risk for U.S.
population. EPA has classified
cyfluthrin as ‘‘not likely to be
carcinogenic to humans’’ and concludes
that it poses no greater than a negligible
cancer risk to humans.
6. 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 cyfluthrin
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography (GC)/electroncapture detection (ECD)) is available to
enforce the tolerance expression. The
method may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
B. International Residue Limits
With regard to international MRLs for
cyfluthrin, harmonization of the
proposed tolerances is not an issue for
grass forage, grass hay, sugar beet roots,
and sugar beet dried pulp, as there are
no established or proposed Canadian,
Mexican or Codex MRLs for cyfluthrin
residues on grass or sugar beet
commodities.
ebenthall on PRODPC61 with RULES
C. Explanation of Tolerance Revisions
1. Grasses. The available field trial
data support the use of up to four
broadcast foliar applications of
cyfluthrin (EC) to grasses grown
throughout the United States at a
maximum single application rate of
0.044 lb active ingredient/Acre (ai/A),
with a minimum RTI of 5 days, for a
maximum of 0.178 lb ai/A/season. The
data also support a 0–day preharvest
interval for cutting of both forage and
hay. The available data support
tolerances of 50 ppm on grass hay and
12 ppm on grass forage.
2. Sugar beets. The available field trial
data are adequate. The number and
geographic distribution of the field trials
are adequate, and the appropriate
samples were collected at normal crop
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14:57 Feb 26, 2008
Jkt 214001
maturity. The samples were analyzed
using an adequate analytical method
and the sample storage intervals are
supported by the available storage
stability data. The available data
support the use of cyfluthrin
(suspoemulsion) as a seed treatment for
sugar beets at a rate of 0.035 lb ai/
100,000 seeds. The residue data on roots
support a tolerance of 0.10 ppm. For
both roots and tops, most of the field
trial values were below the LOQ. As a
result, EPA’s statistical tolerance
generator was not used to determine
tolerances.
D. Response to Comments
Comments were received from a
private citizen who opposed the
authorization to sell any pesticide that
leaves a residue on food. The Agency
has received this same comment from
this commenter on numerous previous
occasions and rejects it for the reasons
previously stated in the Federal
Register of January 7, 2005 (70 FR
1349).
V. Conclusion
Therefore, the tolerances are
established for residues of cyfluthrin,
cyano(4-fluoro-3-phenoxy
phenyl)methyl 3-(2,2-dichloroethenyl)2,2-dimethylcyclopropanecarboxylate,
in or on grass, forage, fodder and hay,
group 17, forage at 12 ppm; grass,
forage, fodder and hay, group 17, hay at
50 ppm; beet, sugar, roots at 0.10 ppm;
and beet, sugar, dried pulp at 1.0 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
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
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Frm 00017
Fmt 4700
Sfmt 4700
10395
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 tolerance 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 6, 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).
E:\FR\FM\27FER1.SGM
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List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 14, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.436 is amended by
adding alphabetically commodities to
the table in paragraph (a)(1), and by
removing and reserving paragraph (c) to
read as follows:
I
§ 180.436 Cyfluthrin: tolerances for
residues.
*
*
Parts per
million
Commodity
*
*
*
*
Beet, sugar, roots .....................
Beet, sugar, dried pulp .............
*
*
*
*
Grass, forage, fodder and hay,
group 17, forage ...................
Grass, forage, fodder and hay,
group 17, hay ........................
*
*
*
*
*
0.10
1.0
*
12
50
*
*
*
*
*
*
(c) Tolerances with regional
registrations. [Reserved]
*
*
*
*
*
[FR Doc. E8–3393 Filed 2–26–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0182; FRL–8341–4]
Dibasic Esters (DBE); Exemption from
the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
ebenthall on PRODPC61 with RULES
AGENCY:
SUMMARY: This regulation establishes
exemptions from the requirement of a
tolerance for residues of dibasic esters
(DBE; CAS Reg. No. 95481–62–2) when
used as an inert ingredient solvent and/
or anti-freeze microencapsulated at 10%
weight/weight (W/W) or less in
VerDate Aug<31>2005
14:57 Feb 26, 2008
Jkt 214001
This regulation is effective
February 27, 2008. Objections and
requests for hearings must be received
on or before April 28, 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–2007–0182. 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
web site 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:
Tracy Ward, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9361; e-mail address:
ward.tracyh@epa.gov.
DATES:
1. The authority citation for part 180
continues to read as follows:
I
(a) *
pesticide formulations with the active
ingredient cyfluthrin. Whitmire MicroGen Research Laboratories, Inc.
submitted a pesticide petition 5E4442 to
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA) requesting
exemptions from the requirement of a
tolerance. EPA published in the Federal
Register on August 29, 2007 (72 FR
49689) a proposed rule for this petition
in order to provide the public with an
opportunity to comment on data that
submitted to the Agency after the
publication of the petition’s Notice of
Filing.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
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:
• 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 provides 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 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 the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
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–2007–0182 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
on or before April 28, 2008.
E:\FR\FM\27FER1.SGM
27FER1
Agencies
[Federal Register Volume 73, Number 39 (Wednesday, February 27, 2008)]
[Rules and Regulations]
[Pages 10390-10396]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3393]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0857; FRL-8350-3]
Cyfluthrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
cyfluthrin in or on grass, forage, fodder and hay group 17, forage at
12 ppm; grass, forage, fodder and hay, group 17, hay at 50 ppm; beet,
sugar, roots at 0.10 ppm; and beet, sugar, dried pulp at 1.0 ppm.
Interregional Research Project Number 4 (IR-4), and Bayer CropScience
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective February 27, 2008. Objections and
requests for hearings must be received on or before April 28, 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-2006-0857. 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
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: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@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), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
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
[[Page 10391]]
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-2006-0857 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before April 28, 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-2006-0857, 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
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket'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 Registers of October 27, 2006 (71 FR 63011) (FRL-
8100-2), and May 9, 2007 (72 FR 26372) (FRL-8121-5) EPA issued notices
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide petitions (PP) 6E7058 by IR-4, 500
College Road East, Suite 201 W, Princeton, NJ, 08540; and (PP) 6F7160
by Bayer CropScience, 2.T.W. Alexander Drive, PO Box 12014, Research
Triangle Park, NC 27709. The petitions requested that 40 CFR 180.436 be
amended by establishing tolerances for residues of the insecticide
cyfluthrin, cyano(4-fluoro-3-phenoxyphenyl)methyl 3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate, in or on grass,
forage at 15 parts per million (ppm) (PP 6E7058); grass, hay at 40 ppm
(PP 6E7058); beet, sugar, roots at 0.09 ppm (PP 6F7160); and beet,
sugar, dried pulp at 11 ppm (PP 6F7160). The notices referenced a
summary of the petition prepared by Bayer CropScience, the registrant,
which is available to the public in the docket, https://
www.regulations.gov. Comments were received from a private citizen on
the notices of filing concerning the tolerances for grass, forage;
grass, hay; beet, sugar, roots; and beet, sugar, dried pulp. EPA's
response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
revised the commodity and/or tolerance expressions for the proposed
petitions. The reason for these changes is explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for residues of cyfluthrin on grass, forage, fodder and hay, group 17,
forage at 12 ppm; grass, forage, fodder and hay, group 17, hay at 50
ppm; beet, sugar, roots at 0.10 ppm; and beet, sugar, dried pulp at 1.0
ppm. EPA's assessment of exposures and risks associated with
establishing the tolerance 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.
Toxicologically, the primary target for cyfluthrin/beta-cyfluthrin
is the neuromuscular system; other non-specific effects include
decreased body weight gain, and decreased food consumption. The
observed neuromuscular effects (tremors, gait abnormities, abnormal
postural reactions, splaying of limbs and decreases in activity)
occurred mainly in oral studies in the dog and the rat. In general, the
toxicity data base does not indicate that any major differences in
toxicity exist between beta-cyfluthrin and cyfluthrin via the oral
route. Data from the inhalation toxicity study showed evidence of
clinical signs as well as hypothermia and decreased body weight gains.
In a postnatal inhalation study in mice, there were clinical signs of
neurotoxicity in the pups as well as increased spontaneous motor
activity and paresthesia (tingling, burning or prickling - also seen in
oral studies).
In oral developmental studies no increased susceptibility was
observed in the rat or rabbit; however, increased susceptibility was
observed in inhalation developmental studies. Increased susceptibility
was also seen in oral reproduction studies and in a
[[Page 10392]]
developmental neurotoxicity study on beta-cyfluthrin. The data also
demonstrate increased susceptibility of rats and mice to cyfluthrin
postnatally.
The database does not indicate that either cyfluthrin or beta-
cyfluthrin induces any endocrine disruption; and, there is no concern
of mutagenicity. EPA has classified cyfluthrin/beta-cyfluthrin as ``not
likely to be carcinogenic to humans.''
Specific information on the studies received and the nature of the
adverse effects caused by cyfluthrin 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 Cyfluthrin:
Human Health Risk Assessment for New Uses on Grasses, Alfalfa, and
Sugar Beet Seed and Revised Tolerances on Cereal Grain Commodities on
pages 54-64 at www.regulations.gov. The referenced document is
available in docket EPA-HQ-OPP-2006-0857.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from 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) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC 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
risks by comparing aggregate 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 LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
A summary of the toxicological endpoints for cyfluthrin used for
human risk assessmentcan be found at https://www.regulations.gov in the
Cyfluthrin: Human Health Risk Assessment for New Uses of Grasses,
Alfalfa, and Sugar Beet Seed and Revised Tolerances on Cereal Grain
Commodities on pages 23 and 24 for docket ID number EPA-HQ-OPP-2006-
0857.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyfluthrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyfluthrin tolerances in (40 CFR
180.436). EPA assessed dietary exposures from cyfluthrin 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 U.S.
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intakes by Individuals (CSFII). As to
residue levels in food, EPA's analysis was based on tolerance level
residues, crop field trial data, Pesticide Data Program (PDP)
monitoring data, percent crop treated, anticipated residues in animal
commodities, and processing factors.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 1994-1996,
and 1998 CSFII. As to residue levels in food, EPA's analysis was based
on tolerance level residues, crop field trial data, PDP monitoring
data, average percent crop treated, anticipated residues in animal
commodities, and processing factors.
iii. Cancer. A cancer dietary exposure analysis was not performed
because EPA has classified cyfluthrin as being ``not likely to cause
cancer in humans.''
iv. Anticipated residue and percent crop treated (PCT) 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 pursuant
to FFDCA section 408(f)(1) require 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 this tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
a. The data used are reliable and provide a valid basis to show
what percentage of the food derived from such crop is likely to contain
such pesticide residue.
b. The exposure estimate does not underestimate exposure for any
significant subpopulation group.
c. Data are available on pesticide use and food consumption in a
particular area, the exposure estimate does not understate exposure for
the population in such area. In addition, the Agency must provide for
periodic evaluation of any estimates used. To provide for the periodic
evaluation of the estimate of PCT as required by FFDCA section
408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency used PCT information for chronic dietary exposures as
follows:
Almond 1%; cabbage 5%; cantaloupe 1%; field corn 5%; cotton 10%;
cucumber 1%; pecan 1%; pepper 10%; potato 25%; pumpkin 1%; sorghum 1%;
soybean 1%; squash 5%; sugarcane 1%; sunflower 1%; and watermelon 2.5%.
EPA uses an average PCT for the acute and chronic dietary risk
analysis. The average PCT figure for each existing use is derived by
combining available federal, state, and private market survey data for
that use, averaging by year, averaging across all years, and rounding
up to the nearest multiple of 5% except for those situations in which
the average PCT is less than one. In those cases <1% is used as the
average and <2.5% is used as the maximum. EPA uses a maximum PCT for
acute dietary risk analysis. The maximum PCT figure is the single
maximum value reported overall from available Federal, State, and
private market survey data on the existing use, across all years, and
rounded up to the nearest multiple of 5%. In most cases, EPA uses
available data from United States Department of Agriculture/National
Agricultural Statistics Service (USDA/NASS), Proprietary Market
Surveys, and the National Center for Food and Agriculture Policy
(NCFAP) for the most recent 6 years.
[[Page 10393]]
The Agency used projected PCT information for chronic dietary
exposures as follows:
Apple 69%; collard 22%; grape 15%; kale 13%; mustard greens 7%;
grass <1 %; peach 43%; pear 62%; plum 37%; spinach 39%; turnip 14%, and
wheat 2%.
EPA estimates an upper bound of projected percent crop treated
(PPCT) for a new pesticide use by assuming that the percent crop
treated (PCT) during the pesticide's initial 5 years of use on a
specific crop will not exceed the average PCT of the dominant pesticide
(i.e., the one with the greatest PCT) on that crop over the three most
recent surveys. EPA calls this the market leader PPCT estimate. The
average market leader PCTs may be based on one or two survey years if
three are not available. Also, with limited availability of data, the
average market leader PCTs may be based on a cross-section of state
PCTs. Comparisons are only made initially among pesticides of the same
pesticide type (e.g., leading insecticides on the crop compared with
the new insecticide), or, for more refined estimates, comparisons may
be made among pesticides in a subcategory of the same pesticide type
(e.g., leading pyrethroid insecticides compared with the new pyrethroid
insecticide). The PCTs included in the average may be each for the same
pesticide or for different pesticides since the same or different
pesticides may dominate each year selected. Typically, EPA uses U.S.
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS) as the source for raw PCT data because it is publicly
available. When a specific crop is not surveyed by USDA/NASS, EPA uses
other sources including proprietary data and calculates the estimated
PCT.
An estimated PPCT, based on the average PCT of the market leaders,
is appropriate for use in chronic dietary risk assessment. This method
of estimating PPCT for a new use of a registered pesticide or a new
pesticide produces high-end estimate that is unlikely, in most cases,
to be exceeded during the initial 5 years of actual use. Predominant
factors that bear on whether the PPCT could be exceeded may include
PCTs of similar chemistries, pests controlled by alternatives, pest
prevalence in the market and other factors. All relevant information
currently available for predominant factors has been considered for the
use of cyfluthrin on apples, cabbage, cauliflower, collards, grapes,
kale, mustard greens, pasture/rangeland, peaches, pears, peas, plums,
spinach, turnip greens, and wheat. It is unlikely that actual PCTs for
cyfluthrin will exceed the corresponding estimated PPCTs during the
next 5 years because cyfluthrin shares many pest control attributes and
constraints with other members of the pyrethroid class and will likely
replace or be used in a similar manner to currently registered
pyrethroids.
The Agency believes that the three conditions listed above have
been met. With respect to Condition a, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. The Agency is reasonably certain that the percentage of
the food treated is not likely to be an underestimation. As to
Conditions b and c, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which cyfluthrin may
be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for cyfluthrin in drinking water. 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 environmental fate characteristics of
cyfluthrin. 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 survey of all the currently registered and proposed uses
of cyfluthrin, it was determined that cyfluthrin use on alfalfa and
cotton would lead to the highest surface water and ground water
estimated groundwater concentrations (EDWCs), respectively. Based on
the First Index Reservoir Screening Tool (FIRST), and Screening
Concentration in Ground Water (SCI-GROW) models, the estimated
environmental concentrations (EECs) of cyfluthrin are estimated to be
3.677 parts per billion (ppb) and 0.155 ppb for acute and chronic
exposure in surface water respectively. The EEC for chronic groundwater
exposure is 0.457 ppb.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 3.677 ppb was used to
access the contribution of residues in drinking water to dietary risk.
For chronic dietary risk assessment, the water concentration of value
0.457 ppb was used to access 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).
Cyfluthrin products are registered for use at residential sites
including indoor (total release fogger, and crack and crevice spray),
and outdoor uses (spray fogger, and lawn applications). Residential
exposure for adults was assessed via the inhalation and dermal routes,
while exposure for infants and children was assessed via inhalation,
dermal, and oral (hand-to-mouth) routes. Exposure for outdoor handlers
was assessed via the Inhalation and dermal routes. Residential
applicator for indoor total release fogger was not assessed
quantitatively, because indoor inhalation exposure to a homeowner would
likely be less than inhalation exposure to homeowner that would result
from outdoor lawn treatments.
Residential MOEs were assessed for indoor and outdoor uses for
application and post-application exposures. This is considered a
conservative assessment assuming the lawn and carpet uses happen on the
same day.
4. Cumulative effects from substances with a common mechanism of
toxicity. Cyfluthrin and beta-cyfluthrin are members of the pyrethroid
class of pesticides. Although all pyrethroids alter nerve function by
modifying the normal biochemistry and physiology of nerve membrane
sodium channels, EPA is not currently following a cumulative risk
approach based on a common mechanism of toxicity for the pyrethroids.
Although all pyrethroids interact with sodium channels, there are
multiple types of sodium channels and it is currently unknown whether
the pyrethroids have similar effects on all channels. The Agency does
not have a clear understanding of effects on key downstream neuronal
function e.g.,
[[Page 10394]]
nerve excitability, nor does the Agency understand how these key events
interact to produce their compound specific patterns of neurotoxicity.
There is ongoing research by EPA's Office of Research and Development
and pyrethroid registrants to evaluate the differential biochemical and
physiological actions of pyrethroids in mammals. When the results of
the research become available, the Agency will consider the findings
and make a determination of common mechanism as a basis for assessing
cumulative risk. Information regarding EPA's procedures for cumulating
effects from substances found to have a common mechanism can be found
on EPA's website at https://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1.In general. Section 408 of FFDCA provides that EPA shall apply an
additional (``10X'') tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
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 FQPA safety factor. In applying
this provision, EPA either retains the default value of 10X when
reliable data do not support the choice of a different factor, or, if
reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility of rats or rabbits in utero exposure in
developmental oral studies; however, there was some indication of
increased susceptibility in developmental inhalation studies. A clear
NOAEL was established for the fetal effects in every case. No residual
uncertainties were identified.
The data also showed increased susceptibility of rats and mice from
postnatal exposure to cyfluthrin. A clear NOAEL was established for the
offspring effects in every case. No residual uncertainties were
identified.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicology databases for cyfluthrin and beta-cyfluthrin
together are considered complete and adequate for selecting toxicity
endpoints for risk assessment. The toxicity profiles of both cyfluthrin
and beta-cyfluthrin can be characterized for all effects, including
potential developmental, reproductive and neurotoxic effects. Exposure
data are complete or are estimated based on data that reasonably
accounts for potential exposures.
ii. There is no evidence of increased susceptibility of rats or
rabbits to in utero exposure in developmental oral studies, and the
degree of concern for the effects observed in the inhalation
developmental studies is considered low since a clear NOAEL was
established for the fetal effects in every case.
iii. The NOAEL used for short-term inhalation exposure scenarios is
protective of the effects seen in the developmental studies via the
inhalation route.
iv. The degree of concern for the effects observed in the
reproductive studies was considered low since a clear NOAEL was
established for the offspring effects in every case.
v. The NOAEL used to establish the cPAD for all populations is
protective of the effects seen in the young in the reproduction
studies.
vi. A beta-cyfluthrin developmental neurotoxicity study has been
submitted for review and indicated both the LOAEL and NOAEL from this
study are higher than the LOAEL and NOAEL chosen for risk assessment
purposes.
vii. There are no residual uncertainties identified in the exposure
databases. Although the acute and chronic food exposure assessments are
refined, EPA believes that the assessments are based on reliable data
and will not underestimate exposure/risk. The drinking water estimates
were derived from conservative screening models. The residential
exposure assessment utilizes reasonable high-end variables set out in
EPA's Occupational/Residential Exposure SOPs (Standard Operating
Procedures). The aggregate assessment is based upon reasonable worst-
case residential assumptions, and is also not likely to underestimate
exposure/risk to any subpopulation, including those comprised of
infants and children.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to cyfluthrin will occupy 53% of the aPAD for the population group
children 1 to 2 years old receiving the greatest exposure. Therefore,
EPA does not expect the aggregate exposure to exceed 100% of the aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
cyfluthrin from food and water will utilize 17% of the cPAD for the
population group children 1 to 2 years old receiving the greatest
exposure. Based on the use pattern, chronic residential exposure to
residues of cyfluthrin is not expected. Therefore, EPA does not expect
the aggregate exposure to exceed 100% of the cPAD.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Cyfluthrin is currently
registered for use(s) that could result in short-term residential
exposure and the Agency has determined that it is appropriate to
aggregate chronic food and water and short-term exposures for
cyfluthrin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential
exposures aggregated result in aggregate MOEs of 320 for children 1 to
2 years old; 400 for infants < 1 year old; and 420 for the U.S.
population. These aggregate MOEs do not exceed the Agency's level of
concern for aggregate exposure to food, water and residential uses.
Therefore, EPA does not expect short-term aggregate exposures to exceed
the Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Cyfluthrin is currently registered for use(s) that could result in
intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for cyfluthrin. Using the exposure
assumptions described in this unit for intermediate-term exposures, EPA
has concluded that food, water, and residential exposures aggregated
[[Page 10395]]
result in aggregate MOEs of 220 for the U.S. population; 240 for
infants < 1 year old; and 230 for children 1 to 2 years old. These
aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food, water and residential uses. Therefore, EPA
does not expect intermediate-term aggregate exposures to exceed the
Agency's level of concern.
5. Aggregate cancer risk for U.S. population. EPA has classified
cyfluthrin as ``not likely to be carcinogenic to humans'' and concludes
that it poses no greater than a negligible cancer risk to humans.
6. 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 cyfluthrin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography (GC)/electron-
capture detection (ECD)) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
With regard to international MRLs for cyfluthrin, harmonization of
the proposed tolerances is not an issue for grass forage, grass hay,
sugar beet roots, and sugar beet dried pulp, as there are no
established or proposed Canadian, Mexican or Codex MRLs for cyfluthrin
residues on grass or sugar beet commodities.
C. Explanation of Tolerance Revisions
1. Grasses. The available field trial data support the use of up to
four broadcast foliar applications of cyfluthrin (EC) to grasses grown
throughout the United States at a maximum single application rate of
0.044 lb active ingredient/Acre (ai/A), with a minimum RTI of 5 days,
for a maximum of 0.178 lb ai/A/season. The data also support a 0-day
preharvest interval for cutting of both forage and hay. The available
data support tolerances of 50 ppm on grass hay and 12 ppm on grass
forage.
2. Sugar beets. The available field trial data are adequate. The
number and geographic distribution of the field trials are adequate,
and the appropriate samples were collected at normal crop maturity. The
samples were analyzed using an adequate analytical method and the
sample storage intervals are supported by the available storage
stability data. The available data support the use of cyfluthrin
(suspoemulsion) as a seed treatment for sugar beets at a rate of 0.035
lb ai/100,000 seeds. The residue data on roots support a tolerance of
0.10 ppm. For both roots and tops, most of the field trial values were
below the LOQ. As a result, EPA's statistical tolerance generator was
not used to determine tolerances.
D. Response to Comments
Comments were received from a private citizen who opposed the
authorization to sell any pesticide that leaves a residue on food. The
Agency has received this same comment from this commenter on numerous
previous occasions and rejects it for the reasons previously stated in
the Federal Register of January 7, 2005 (70 FR 1349).
V. Conclusion
Therefore, the tolerances are established for residues of
cyfluthrin, cyano(4-fluoro-3-phenoxyphenyl)methyl 3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate, in or on grass,
forage, fodder and hay, group 17, forage at 12 ppm; grass, forage,
fodder and hay, group 17, hay at 50 ppm; beet, sugar, roots at 0.10
ppm; and beet, sugar, dried pulp at 1.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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 tolerance 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 6, 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).
[[Page 10396]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 14, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, 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 180.436 is amended by adding alphabetically commodities to
the table in paragraph (a)(1), and by removing and reserving paragraph
(c) to read as follows:
Sec. 180.436 Cyfluthrin: tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Beet, sugar, roots......................................... 0.10
Beet, sugar, dried pulp.................................... 1.0
* * * * *
Grass, forage, fodder and hay, group 17, forage............ 12
Grass, forage, fodder and hay, group 17, hay............... 50
* * * * *
------------------------------------------------------------------------
* * * * *
(c) Tolerances with regional registrations. [Reserved]
* * * * *
[FR Doc. E8-3393 Filed 2-26-08; 8:45 am]
BILLING CODE 6560-50-S