processes. These models were summarized in Unit V.B.2.
    There are sources of uncertainty associated with estimating
exposure of carbofuran in surface water source drinking water. Several
of the most significant of these are the effect of treatment in
removing carbofuran from finished drinking water before it is delivered
to the consumer supply system, the impact of percent crop treated
assumptions, and the variation in pH across the landscape. The effect
of the percent crop treated assumption in the case of carbofuran is
discussed in detail in EPA's assessment of additional data submitted by
the registrant (Refs. 22 and 94) and summarized below. Available data
on the degree to which carbofuran may be removed from treatment systems
was summarized previously and is discussed in more detail in Appendix
E-3 of the Revised NMC CRA (Ref. 107). Although EPA is aware of the
mitigating effects of specific treatment processes, the processes
employed at public water supply utilities across the country vary
significantly both from location to location and throughout the year,
and therefore are difficult to incorporate quantitatively in drinking
water exposure estimates. For example, lime softening would likely
reduce carbofuran concentrations. That process is used in 3 to 21% of
drinking water treatment systems in the United States (Ref. 19).
Activated carbon has been shown to also reduce carbofuran
concentrations, but is used in 1 to 15% of drinking water treatment
facilities (Ref. ibid.). Therefore, EPA assumes that there is no
reduction in carbofuran concentrations in surface water source drinking
water due to treatment, which is a source of conservatism in surface
water exposure estimates used for human health risk assessment. While
it is well established that carbofuran will degrade at higher rates
when the pH is above 7, and lower rates when below pH 7, due to the
high variation of pH across the country for many of the scenarios, a
neutral pH (pH 7) default value was used to estimate water
concentrations. Finally, available environmental fate studies do not
show formation of 3-hydroxycarbofuran through most environmental
processes except soil photolysis, where in one study it was detected in
very low amounts. Although 3-hydroxycarbofuran was not explicitly
considered as a separate entity in the drinking water exposure
assessment, it is unclear whether it would significantly add to
exposure estimates.
    EPA compiled a distribution of estimated carbofuran concentrations
in surface water in order to conduct probabilistic assessments of the
potential exposures from drinking water. For the IRED, EPA modeled
crops representing 80 percent of total carbofuran use at locations that
would be considered among the more vulnerable where the crops are
grown. Subsequently, for a refined dietary risk assessment, EPA
generated distributions for 13 different scenarios representing all
labeled uses of carbofuran treated at maximum label rates and adjusted
with PCA factors (Refs. 17, 53, and 84).
    EPA subsequently conducted several rounds of modeling to refine
estimates for specific uses and agricultural practices. One set of
refinements addressed use of carbofuran on corn at

typical rather than maximum label rates, another set included
simulation of different types of applications to corn (e.g.,
applications to control European corn borer, a rescue treatment for
corn rootworm, and an in-furrow application at plant).
    For this final rule, EPA conducted additional refined modeling,
based on the September 2008 label submitted by FMC. The modeling
addressed all of the domestic uses that remain registered, and included
certain refinements to better understand the impacts of varying pH. EPA
also conducted modeling to assess the impact of the proposed spray
drift buffer requirements and other spray drift measures included on
the September label.
    EPA estimated carbofuran concentrations resulting from the use on
pumpkins by adjusting the EDWCs from a previous run simulating melons
in Missouri; adjustments accounted for differences in application rate
and row spacing. Two EDWCs were calculated for pumpkins: One based on a
36-inch row spacing, representing pumpkins for consumption (77.6 [mu]g/
L); and a second based on a 60-inch row spacing, representing
decorative pumpkins (46.6 [mu]g/L).
    EPA had previously evaluated the corn rootworm rescue treatment at
seven representative sites, representing use in states with extensive
carbofuran usage at locations more vulnerable than most in each state
in areas corn is grown. Using measured rainfall values, and assuming
typical rather than maximum use rates, peak concentrations for the corn
rescue treatments simulated for Illinois, Iowa, Indiana, Kansas,
Minnesota, Nebraska, and Texas ranged from 16.6 - 36.7 ppb (Ref. 61).
Under the revised assessment to account for the new use restrictions,
concentrations for corn, calculated including the proposed spray drift
buffers in Kansas and Texas, decreased 5.1% and 4.7%, respectively,
from simulations with no buffer from the previous assessment (Ref. 61).
In Kansas, the 1-in-10-year peak EDWCs decreased from 33.5 to 31.8 ppb
when a 300-foot buffer was added, and in Texas, from 29.9 to 28.5 ppb
with the addition of a 66-foot buffer.
    For the sunflower use, 12 simulations were performed for
sunflowers, 9 in Kansas, and 3 in North Dakota. The North Dakota
scenario was used to represent locations where sunflowers are grown
that are vulnerable to pesticide movement to surface water while the
Kansas scenario represents places that are not particularly vulnerable,
based on the limited rainfall and generally well-drained soils
(hydrologic group B soils) that are found in that area. Estimated 1-in-
10-year concentrations ranged from 11.6 to 32.7 [mu]g/L. When
simulating three applications, one at plant and two foliar with a 14-
day interval between the two foliar applications and a 66-foot buffer,
the 1-in-10-year peak EDWC for North Dakota was 22.4 [mu]g/L. In
contrast, the same three applications in Kansas with a 14-day interval
between the foliar applications and a 300-foot buffer produced a 1-in-
10-year peak EDWC of 20.5 [mu]g/L. The 1-in-10-year peak EDWCs assuming
that carbofuran is applied only at plant were 14.0 and 16.0 [mu]g/L in
Kansas and North Dakota respectively. EPA also evaluated the impact of
pH on carbofuran concentrations for sunflowers, resulting in a 10%
decrease in 1-in-10-year peak concentrations assuming high pH in the
reservoir. Spray drift buffers of 66 and 300 feet decreased
concentrations 4.7 and 5.1% for corn and 10.0% and 16.0% for
sunflowers, respectively, in comparison to previous labels that had no
spray drift buffer requirements. Additional details on these
assessments can be found at Reference 111. Consistent with the analysis
summarized above these predicted carbofuran water concentrations are
similar or lower than the peak concentrations reported in the USGS-
NAWQA monitoring data and similar to or not more than tenfold higher
than the 4 ppb reported in finished water from a surface water drinking
plant.
    There are few surface water field-scale studies targeted to
carbofuran use that could be compared with modeling results. Most of
these studies were conducted in fields that contain tile drains, which
is a common practice throughout midwestern states to increase drainage
in agricultural fields (Ref. 17). Drains are common in the upper
Mississippi river basin (Illinois, Iowa, and the southern part of
Minnesota), and the northern part of the Ohio River Basin (Indiana,
Ohio, and Michigan) (Ref. 74). Although it is not possible to directly
correlate the concentrations found in most of the studies with drinking
water concentrations, these studies confirm that carbofuran use under
such circumstances can contaminate surface water, as tile drains have
been identified as a conduit to transport water and contaminants from
the field to surface waters. For example, one study conducted in the
United Kingdom in 1991 and 1992 looked at concentrations in tile drains
and surface water treated at a rate of 2.7 lbs a.i. per acre (granular
formulation). Resulting concentrations in surface water downstream of
the field ranged from 49.4 ppb almost 2 months after treatment to 0.02
ppb 6 months later, and were slightly lower than concentrations
measured in the tile drains, which were a transport pathway. Even with
the factors that limit the study's relevance to the majority of current
carbofuran use--the high use rate and granular formulation--the study
clearly confirms that tile drains can serve as a source of significant
surface water contamination. Although EPA's models do not account for
tile drain pathways, and acknowledging the uncertainties in comparing
carbofuran monitoring data to the concentrations predicted from the
exposure models, as noted previously, estimated (model-derived) peak
concentrations of carbofuran are similar to peak concentrations
reported in stream monitoring studies. These are no more than tenfold
higher than a value reported from a drinking water plant where it is
unlikely the sample design would have ensured that water was sampled on
the day of the peak concentration.
    EPA conducted dietary exposure analyses based on the modeling
scenarios for the proposed September 2008 label. Exposures from all
modeled scenarios substantially exceeded EPA's level of concern (Ref.
16). For example, a Kansas sunflower scenario, assuming two foliar
applications at a typical 1-lb a.i. per acre use rate, applied at 14-
day intervals, estimated a 1-in-10-year peak carbofuran water
concentration of 11.6 ppb. Exposures at the 99.9th percentile based on
this modeled distribution ranged from 160% of the aPAD for youths 13 to
19 years, to greater than 2,000% of the aPAD for infants. As previously
noted, this scenario is intended to be representative of sites that are
less vulnerable than most on which sunflowers could be grown. By
contrast, exposure estimates from a comparable North Dakota sunflower
scenario, intended to represent more vulnerable sites, estimated a 1-
in-10-year peak concentration of 22.4 ppb. These concentrations would
result in estimated exposures ranging between 450% aPAD for youths 13
to 19 years, to 5,500% aPAD for infants. Similarly, exposures based on
a Washington surface water potato scenario, and using a 3 lb a.i. acre
rate, ranged from 230% of the aPAD for children 6 to 12 years to 890%
of the aPAD for infants, with a 1-in-10-year peak carbofuran
concentration of 7.2 ppb. Although other crop scenarios resulted in
higher exposures, estimates for these two crops are presented here, as
they are major

crops on which a large percentage of carbofuran use occurs. More
details on these assessments, as well as the assessments EPA conducted
for other crop scenarios, can be found in References 16, 61, and 84.
    Restricting the sunflower application to a single at-plant
application from three applications reduces the 1-in-10-year peak EDWCs
from 32.7 to 16.0 [mu]g/L for the North Dakota scenario and from 20.5
to 14.0 [mu]g/L in western Kansas. These concentrations would result in
estimated exposures, based on the North Dakota scenario ranging between
350% aPAD for youths 13 to 19 years, to 4,300% aPAD for infants. Based
on the Kansas scenario, the estimated exposures would range between
250% aPAD for youths 13 to 19 years, to 3,100% aPAD for infants.
    Table 4 below presents the results of one of EPA's refined exposure
analyses that is based on a Nebraska corn rootworm ``rescue treatment''
scenario, and assumes a single aerial application at a typical rate of
1-pound a.i. per acre. To simulate an application made post-plant, at
or near rootworm hatch, EPA modeled an application of carbofuran 30
days after crop emergence. EPA used a crop specific PCA of 0.46 which
is the maximum proportion of corn acreage in a HUC-8-sized basin in the
United States. (The USGS has classified all watersheds in the United
States into basins of various sizes, according to hydrologic unit
codes, in which the number of digits indicates the size of the basin).
The full distribution of daily concentrations over a 30-year period was
used in the probabilistic dietary risk assessment. The 1-in-10-year
peak concentration of the distribution of values for the Nebraska corn
rescue treatment was 22.3 ppb. More details on these assessments, as
well as the assessments EPA conducted for other crop scenarios, can be
found in References 16, 61, and 84.

           Table 4.--Results of Acute Dietary (Surface Water Only) Exposure Analysis Incorporating the Nebraska Corn Rootworm Rescue Scenario
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                95th Percentile         99th Percentile        99.9th Percentile
                                                                     aPAD (mg/kg/-----------------------------------------------------------------------
                        Population Subgroup                              day)       Exposure                Exposure                Exposure
                                                                                (mg/kg/day)    % aPAD   (mg/kg/day)    % aPAD   (mg/kg/day)    % aPAD
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old)                                              0.000075     0.000424        560     0.001201      1,600     0.002895      3,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                                  0.000075     0.000182        240    0.0005047        670     0.001261      1,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                                  0.000075     0.000169        230     0.000461        620     0.001137      1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 6-12 years old                                                 0.000075     0.000117        160     0.000320        430     0.000794      1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                                                     0.0002     0.000087         43     0.000248        120     0.000760        380
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                                                    0.0002     0.000113         57     0.000305        150     0.000760        380
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                                      0.0002     0.000120         60     0.000300        150     0.000672        340
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The populations described in the ``Nebraska corn'' assessments are
those people who consume water from a reservoir located in a small
watershed predominated by corn production (with the assumption that
treatment does not reduce carbofuran concentrations). The only crop
treated by carbofuran in the watershed is corn, and all of that crop is
assumed treated with carbofuran at the rate of 1 lb per acre. To the
extent a drinking water plant drawing water from the reservoir normally
treats the raw intake water with lime softening or activated carbon
processes the finished water concentrations could be reduced from 60 to
100% with the resultant aPADs ranging from approximately 198% to 2,340%
of the aPAD to 0% of the aPAD, respectively, at the 99.9th percentile
of exposure.
    As discussed in the previous sections, it is important to remember
that carbofuran's aPAD is quite low, hence relatively low
concentrations of carbofuran monitored or estimated in surface water
can have a significant impact on the percent of the aPAD utilized.
Thus, while the refined carbofuran water concentrations for the corn
``rescue'' treatment in the range of approximately 16.6 to 36.7 ppb are
comparable to maximum peak concentrations reported in the monitoring
studies, these concentrations can result in very significant
exceedences of the aPAD for various age groups, primarily because
carbofuran is inherently very toxic.
    As noted, EPA's modeling indicates that while there is some
mitigation value in the use of spray drift buffers, the loading to
surface water is dominated by runoff even in semi-arid locations such
as western Kansas, and the proposed mitigation measures do not
substantially reduce exposure to carbofuran in surface water source
drinking water systems.
    It is important to note that spray drift calculations have been
conducted assuming that certain BMPs were used during the aerial spray
application. Those practices are [frac12] swath displacement windward,
a 10 foot release, wind speed no greater than 10 mph, and a spray boom
less than 75% of the aircraft's wing (Ref. 106). There is advisory
language on the revised labels regarding wind speed (``Drift potential
increases at wind speeds less the 3 mph (due to inversion potential) or
more than 10 mph,'' and boom height (``setting the boom to the lowest
height (if specified) which provides uniform coverage reduces the
exposure of droplets to evaporation and wind.''). The boom width is
specifically restricted (``the boom length should not exceed [frac34]
the wing or rotor length.''). There is no language on the label
regarding swath displacement. While these ``best management practices''
are frequently used by aerial applicators, they are not used
universally. To the extent these management practices are not used,
EPA's assessment would underestimate the additional loading expected to
result from spray drift.
    Equally important is that EPA only assumed that the buffers would
be effective in reducing spray drift from neighboring fields, rather
than assuming that the buffers would be effective in preventing or
mitigating field runoff. As explained in the proposed rule, EPA
disagrees that these measures will be effective in reducing
carbofuran's movement to surface water. The proposed buffers were for
fields where

soils were considered to be highly erodible. Buffer widths varied, and
were to be vegetated with ``crop, seeded with grass, or other suitable
crop.'' In 2000, EPA participated in the development of a guidance
document on how to reduce pesticide runoff using conservation buffers
(Ref. 98). Results of this effort found that properly designed buffers
can reduce runoff of weakly absorbed pesticides like carbofuran by
increasing filtration so that the pesticide can be trapped and degraded
in the buffer. However, it is of critical importance that sheet flow be
maintained across the buffer in order for this to occur. To ensure
sheet flow, buffers need to be specifically designed for that purpose
and they must be well-maintained, as over time sediment trapped in the
buffer causes flow to become more channelized and the buffer then
becomes ineffective. The guidance concludes that un-maintained, un-
vegetated buffers around water bodies, often referred to a `setback,'
are ineffective in reducing pesticide movement to surface water.
    As discussed in Unit VII.C.2., FMC has criticized EPA's assessment
for failing to account more fully for the percent of the crop likely to
be treated in its modeling. In response to FMC's concerns, EPA
performed a sensitivity analysis of an exposure assessment using a PCT
in the watershed to determine the extent to which some consideration of
this factor could meaningfully affect the outcome of the risk
assessment. The registrant has at different times, suggested the
application of a 5 or 10% crop treated factor based on county sales
data. While substantial questions remain as to the support for these
percentages for a given basin where carbofuran may be used, EPA used
the upper figure for the purpose of conducting a sensitivity analysis.
To be clear, this means that EPA assumed that 10% of the 46% of the
watershed on which corn could be grown, would be treated with
carbofuran, resulting in less than 5% of the watershed treated with
carbofuran--an assumption that clearly underestimates exposures in many
highly agricultural areas, such as Nebraska, and as discussed
previously, requires several unrealistic assumptions. The results
suggest that, even at levels below 10% crop treated, exposures from
drinking water derived from surface waters can contribute significantly
to the aggregate dietary risks, particularly for infants and children.
For example, applying a 10% crop treated figure to the Nebraska corn
scenario described above, in addition to the corn-PCA of 0.46
incorporated into that scenario, results in estimated exposures from
water alone, ranging from 110% of the aPAD for children 6 to 12 years
to 390% of the aPAD for infants, assuming water treatment processes do
not affect concentrations in drinking water consumed. Details on the
assessments EPA conducted for other crop scenarios, which showed higher
contributions from drinking water, can be found in References 16, 17,
and 84. Accordingly, these assessments suggest that EPA's use of PCA
alone, rather than in conjunction with PCT, will not meaningfully
affect the carbofuran risk assessment, as even if EPA were to apply an
extremely low PCT, aggregate exposures would still exceed 100% of the
aPAD.
    In response to this sensitivity analysis, which had been presented
in the proposed rule, FMC complained that EPA had failed to account in
these analyses for the rapid nature of carbofuran's recovery. Or in
other words, the commenter wanted EPA to both apply a PCT figure and
conduct an Eating Occasion Analysis, claiming that this analysis would
show that carbofuran ``passed.''
    EPA disagrees that conducting the analysis the commenter suggests
would be appropriate, or would provide any information on which EPA
could properly rely to support a determination of safety. As previously
explained, the available information and methodology does not allow EPA
to generate PCT estimates with any degree of confidence, and certainly
not with the ``reasonable certainty'' demanded by the statute. EPA
conducted its analysis purely in an attempt to understand the extent to
which its assumption of PCT affected the risk assessment conclusions.
It is not necessary to gain an understanding of the PCT impact, to
compound the uncertainty by adding assumptions about the reversibility
of carbofuran's effects.
    The commenter provided the results of their dietary assessment, in
which they appear to have conducted the analysis suggested above, and
reported that the aPAD for infants from aggregate exposures (i.e., food
+ water) was 107.06%. As previously discussed, the commenter did not
provide any of the underlying support documentation for these reported
results, and EPA was unable to replicate them. However, in its efforts
to replicate the commenter's analysis, the lowest aggregate exposure
EPA was able to estimate for infants using the commenter's PCT and
half-life inputs was 126% of the aPAD, a figure that, for reasons
discussed subsequently, is certainly an underestimate of exposure.
Further discussion of the Eating Occasion Analyses EPA conducted for
carbofuran is presented in Unit VIII.E.1.d. and in Reference 112.
    In conclusion, the large difference between concentrations seen in
the monitoring data on the low side, and the simulation modeling on the
high side, is an indication of the uncertainty in the assessment for
surface-water source drinking water exposure. The majority of drinking
water concentrations resulting from use of carbofuran are likely to be
occurring at higher concentrations than those measured in most
monitoring studies, but below those estimated with simulation modeling;
however the exact values within the range obtained from the monitoring
and the model simulations are uncertain. However, the monitoring data
show a consistent pattern of low concentrations, with the occasional,
infrequent spike of high concentrations. Those infrequent high
concentrations are consistent with EPA's modeling, which is intended to
capture the exposure peaks. For a chemical with an acute risk, like
carbofuran, the spikes or peaks in exposures, even though infrequent,
are the most relevant for assessing the risks. And, as previously
noted, the available monitoring has its own limitations for estimating
exposure for risk assessment.
    Further, the results of the modeling analyses provide critical
insights regarding locations in the country where the potential for
carbofuran contamination to surface water and associated drinking water
sources is more likely. These locations include areas with soils prone
to runoff (such as those high in clay or containing restrictive
layers), in regions with intensive agriculture with crops on which
carbofuran is used (e.g., corn), which have high rainfall amounts and/
or are subject to intense storm events in the spring around the times
applications are being made. Drinking water facilities with small
basins tend to be more vulnerable, as it is more likely that a large
proportion of the crop acreage will be treated in small basins.
    3. Aggregate dietary exposures (food and drinking water). EPA
conducted a number of probabilistic analyses to combine the national
food exposures with the exposures from the individual region and crop-
specific drinking water scenarios. As discussed in Unit V.B.3.,
although food is distributed nationally, and residue values are
therefore not expected to vary substantially throughout the country,
drinking water is locally derived and concentrations of pesticides in
source water fluctuate over

time and location for a variety of reasons. Consequently, EPA conducted
several estimates of aggregate dietary risks by combining exposures
from food and drinking water. These estimates showed that, because
drinking water exposures from any of the crops on the label exceed safe
levels, aggregate exposures from food and water are unsafe. Although
EPA's assessments showed that, based on the Idaho potato scenarios,
exposures from ground water from use on potatoes would be safe, surface
water exposures from carbofuran use on potatoes far exceed the safety
standard. More details on the individual aggregate assessments
presented below, as well as the assessments EPA conducted for other
regional and crop scenarios, can be found in References 16 and 17.
    Table 5 reflects the results of aggregate exposures from food and
from drinking water derived from ground water in extremely vulnerable
areas (i.e., from shallow wells associated with sandy soils and acidic
aquifers, such as are found in Wisconsin). The estimates range between
780% of the aPAD for adults, to 9,400% of the aPAD for infants.

             Table 5.--Results of Acute Dietary (Food and Water) Exposure Analysis incorporating the Wisconsin Ground Water Scenario pH 6.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                95th Percentile         99th Percentile        99.9th Percentile
                                                                     aPAD (mg/kg/-----------------------------------------------------------------------
                        Population Subgroup                              day)       Exposure                Exposure                Exposure
                                                                                (mg/kg/day)    % aPAD   (mg/kg/day)    % aPAD   (mg/kg/day)    % aPAD
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old)                                              0.000075     0.001602      2,100     0.003537      4,700     0.007053      9,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                                  0.000075     0.000680        910     0.001490      2,000     0.003180      4,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                                  0.000075     0.000626        840     0.001350      1,800     0.002845      3,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 6-12 years old                                                 0.000075     0.000432        580     0.000935      1,200     0.002019      2,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                                                     0.0002     0.000334        170     0.000751        380     0.001721        860
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                                                    0.0002     0.000415        210     0.000896        450     0.001906        950
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                                      0.0002     0.000415        210     0.000853        430     0.001552        780
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The peak concentration estimates in the Wisconsin ground water
scenario time series are consistent with monitoring data from wells in
vulnerable areas where carbofuran was used. For example, the maximum
water concentration from the time series is 34 ppb while maximum values
from a targeted ground water monitoring study in Maryland, with a
higher application rate, was 65 ppb, with studies at other sites having
similar or higher peak concentrations (Refs. 17 and 84). For studies
with multiple measurements at each well, central tendency estimates
were also in the same range as the time series. For example, the mean
carbofuran concentration from wells under no-till agriculture in
Queenstown, MD was 7 ppb, while the median for the modeling was 15.5
ppb. The 90-day average concentration, based on the registrant's PGW
study conducted on corn in the Delmarva (adjusted for current maximum
application rates) is 11 ppb.
    Table 6 presents the results of aggregate exposure from food and
water derived from one of the least conservative surface water
scenarios: Kansas sunflower, with two foliar applications. This table
reflects the risks only for those people in watersheds with
characteristics similar to that used in the scenario, and assuming that
water treatment does not remove carbofuran. As discussed previously,
the estimated water concentrations are comparable to the maximum peak
concentrations reported in monitoring studies that were not designed to
detect peak, daily concentrations of carbofuran in vulnerable
locations.

  Table 6.--Results of Acute Dietary (Food and Water) Exposure Analysis Using The DEEM-FCID\(TM)\ and Incorporating the Kansas Surface Water Sunflower
                                                           Foliar Application pH 7.8 Scenario
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                95th Percentile         99th Percentile        99.9th Percentile
                                                                     aPAD (mg/kg/-----------------------------------------------------------------------
                        Population Subgroup                              day)       Exposure                Exposure                Exposure
                                                                                (mg/kg/day)    % aPAD   (mg/kg/day)    % aPAD   (mg/kg/day)    % aPAD
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old)                                              0.000075     0.000087        120     0.000425        570     0.001555       2100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                                  0.000075     0.000044         59     0.000185        250     0.000660        880
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                                  0.000075     0.000039         53     0.000172        230     0.000610        800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 6-12 years old                                                 0.000075     0.000027         36     0.000117        160     0.000416        560
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                                                     0.0002     0.000019         10     0.000089         45     0.000330        160
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                                                    0.0002     0.000026         13     0.000114         57     0.000395        200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                                      0.0002     0.000028         14     0.000119         60     0.000373        190
--------------------------------------------------------------------------------------------------------------------------------------------------------

    More details on this assessment, as well as the assessments EPA
conducted for other crop scenarios, can be found in References 16, 61,
and 84. For example, in the proposed rule, EPA presented the results
from aggregate exposures resulting from a Nebraska surface water
scenario based on a Nebraska corn rootworm ``rescue treatment.''
Estimated exposures from that scenario ranged from 330% of the aPAD for
youths 13 to 19 years to 3,900% of the aPAD for infants.
    As noted previously, EPA's food and water exposure assessments
typically sum exposures over a 24-hour period, and EPA used this 24-
hour total in developing its acute dietary risk assessment for
carbofuran. Because of the rapid nature of carbofuran toxicity and
recovery, EPA considered durations of exposure less than 24 hours.
Accordingly, EPA has conducted an analysis using information about
dietary exposure, timing of exposure within a day, and half-life of
AChE inhibition from rats to estimate risk to carbofuran at durations
less than 24 hours. Specifically, EPA has evaluated individual eating
and drinking occasions and used the AChE half-life to recovery
information (herein called half-life information) to estimate the
residual effects from carbofuran from previous exposures within the
day. The carbofuran analyses are described in the 2009 aggregate
(dietary) memo (Ref. 71).
    EPA used the same approach for considering the impact of
carbofuran's rapid reversibility on exposure estimates in the food and
drinking water risk assessments that had been previously used in the
cumulative risk assessment of the NMC pesticides and/or risk
assessments for other NMC pesticides (e.g., methomyl and aldicarb)
(Ref. 107).
    Using the two FMC time course studies in rat pups, EPA calculated
half-lives for recovery of 186 and 426 minutes. The two values were
derived from two different studies using rat pups of the same age
(Refs. 30 and 31); the two values provide an indication that half-lives
to recovery can vary among juvenile rats. By extension, children are
expected to vary in their ability to recover from AChE inhibition where
longer recoveries would be associated with a potentially higher
``persisting dose'' (as described below). Incorporating Eating Occasion
Analysis and the 186-minute or 426-minute recovery half-lives for
carbofuran into the food only analysis does not significantly change
the risk estimates when compared to baseline levels (for which a total
daily consumption basis - and not eating occasion - was used). From
this, it is apparent that modifying the analysis such that information
on eating (i.e., food) occasions and carbofuran half-life is
incorporated results in only minor reductions in estimated risk from
food alone.
    Regarding drinking water exposure, accounting for drinking water
consumption throughout the day and using the half-life to recovery
information, risk is reduced by approximately 2-3X. Consequently, risk
estimates for which food and drinking water are jointly considered and
incorporated (i.e., Food + Drinking Water) are also reduced
considerably--by a factor of two or more in some cases--compared to
baseline. This is not unexpected, as infants receive much of their
exposures from indirect drinking water in the form of water used to
prepare infant formula, as shown in the above example. But even though
the risk estimates from aggregate exposure are reduced, they
nonetheless still substantially exceed EPA's level of concern for
infants and children. Using drinking water derived from the surface
water from the Idaho potato surface water scenario, which estimated one
of the lowest exposure distributions, aggregate exposures at the 99.9th
percentile ranged from 328% of the aPAD under the scenario for which
infants rapidly metabolize carbofuran (e.g., 186 minute half-life), to
a high of 473% of the aPAD under the scenario for which infants
metabolize carbofuran more slowly, (e.g., scenarios in which a 426
minute half life is assumed).
    Moreover, even accounting for the estimated decreased risk from
accounting for carbofuran's rapid reversibility, the Agency remains
concerned about the risks from single eating or drinking events, as
illustrated in the following example, based on an actual food
consumption diary from the CSFII survey. A 4-month old male non-nursing
infant weighing 10 kg is reported to have consumed a total of 1,070
milliters (ml) of indirect water over eight different occasions during
the day. The first eating occasion occurred at 6:30 a.m., when this 4
month old consumed 8 fluid ounces of formula prepared from powder. The
FCID food recipes indicate that this particular food item consists of
approximately 87.7% water, and therefore, 8 ounces of formula contains
approximately 214 ml (or grams) of indirect water; with the powder
(various nutrients, dairy, soy, oils, etc.) accounting for the
remaining 12.3%. This infant also reportedly consumed a full 8-ounce
bottle of formula at 12 p.m., 4 p.m., and 8 p.m. that day. The food
diary also indicates that the infant consumed about 1 tablespoon of
water (14.8 ml) added to prepare rice cereal at 10:00 a.m., about 2
ounces of water (59.3 ml) added to pear juice at 11 a.m., another
[frac12] tsp of water (2.5 ml) to prepare more rice cereal at 8:30
p.m.; and finally, he consumed another 4 ounces of formula (107 ml) at
9:30 p.m.
    The infant's total daily water intake (1,070 ml, or approximately
107 ml/kg/day) is not overly conservative, and represents substantially
less than the 90th percentile value from CSFII on a ml water/kg
bodyweight (ml/kg/bw) basis. As noted, carbofuran has been detected in
finished water at concentrations of 4 ppb. For this 10 kg body weight
infant, an 8-ounce bottle of formula prepared from water containing
carbofuran at 4 ppb leads to drinking water exposures of 0.0856
micrograms of active ingredient/kilogram of bodyweight ([mu]g ai/kg
bw), or 114% of the aPAD. Based on the total daily water intake of
1,070 ml/day (no reversibility), total daily exposures from water at 4
ppb concentration would amount to 0.4158 [mu]g ai/kg bw, or 555% of the
aPAD; this is the amount that would be used for this person-day in the
Total Daily Approach.
    Peak inhibition occurs following each occasion on which the infant
consumed 8 fluid ounces of formula (6 a.m., 12 p.m., 4 p.m. and 8
p.m.); however, the maximum persisting dose occurs following the 9:30
p.m. eating occasion, based on a 186-minute half-life parameter. This
produces a maximum persisting dose of 0.1457 [mu]g ai/kg bw, or about
30% of the total daily exposure of 0.4158 [mu]g ai/kg bw derived above,
or expressed as a fraction of the level of concern, the maximum
persisting dose amounts to about 194% of the aPAD (or 30% of 554%).
Note that with drinking water concentration at 4 ppb, an infant
consuming one 8 oz bottle of formula - prepared from powder and tap
water containing carbofuran at 4 ppb will obtain exposures of
approximately 114% of aPAD. Since many infants consume the equivalent
of this amount on a single eating occasion, accounting for
reversibility over multiple occasions is not essential to ascertain
that infants quite likely have obtained drinking water exposures to
carbofuran exceeding the level of concern based on drinking water
concentrations found in public drinking water supplies.
    The approach discussed above is used to evaluate the extent to
which the Agency's 24-hour approach to dietary risk assessment
overestimates risk from carbofuran exposure. The results of both
approaches indicate that the risk from carbofuran is indeed not
substantively overestimated using the current

exposure models and the 24-hour approach.
    In this regard, it is important to note EPA's Eating Occasion
Analyses underestimate exposures to the extent that they do not take
into account carry-over effects from previous days, and because
drinking water concentrations are randomly picked from the entire 30-
year distribution. As discussed previously, DEEM-FCID\(TM)\ is a single
day dietary exposure model, and the DEEM-based Eating Occasion Analysis
accounts for reversibility within each simulated person-day. All of the
empirical data regarding time and amounts consumed (and corresponding
exposures based on the corresponding residues) from the CSFII survey
are used, along with the half-life to assess an equivalent persisting
dose that produced the peak inhibition expected over the course of that
day. This is a reasonable assumption for food alone; since the time
between exposure events across 2 days is relatively high (compared to
the half-life)--most children (>9 months) tend to sleep through the
night--and the time between dinner and breakfast the following morning
is long enough it is reasonable to ``ignore'' persisting effects from
the previous day. A single day exposure model will underestimate the
persisting effects from drinking water exposures (formula) among
infants, and newborns in particular (<3 months), since newborns tend to
wake up every 2 to 4 hours to feed. Any carry over effects may be
important, especially if exposures from the previous day are relatively
high, since the time between the last feeding (formula) of the day and
the first feeding of the subsequent day is short. A single day model
also does not account for the effect of seasonal variations in drinking
water concentrations, which will make this effect more pronounced
during the high use season (i.e., the time of year when drinking water
concentrations are high). Based on these analyses, the Agency concludes
that the current exposure assessment methods used in the carbofuran
dietary assessment provide realistic and high confidence estimates of
risk to carbofuran exposure through food and water.
    The result of all of these analyses clearly demonstrates that
aggregate exposure from all uses of carbofuran fail to meet the FFDCA
section 408 safety standard, and revocation of the associated
tolerances is warranted. EPA's analyses show that those individuals-
both adults as well as children--who receive their drinking water from
vulnerable sources are also exposed to levels that exceed EPA's level
of concern--in some cases by orders of magnitude. This primarily
includes those populations consuming drinking water from ground water
from shallow wells in acidic aquifers overlaid with sandy soils that
have had crops treated with carbofuran. It could also include those
populations that obtain their drinking water from reservoirs located in
small agricultural watersheds, prone to runoff, and predominated by
crops that are treated with carbofuran, although there is more
uncertainty associated with these exposure estimates.
    Although the recent cancellation of several registered uses has
reduced the dietary risks to children, EPA's analyses still show that
estimated exposures significantly exceed EPA's level of concern for
children.
    While the registrant claims to have conducted an alternate analysis
showing that aggregate carbofuran exposures to children will be safe,
FMC failed to provide the data and details of that assessment to the
Agency. They have also failed to provide several critical components
that served to support key inputs into that assessment. And for several
of these, EPA was unable to replicate the claimed results based on the
information contained in the comments. In the absence of such critical
components, the Agency cannot accept the validity or utility of the
analyses, let alone rely on the results.
    But based on the summary descriptions provided in their comments,
it is clear that the commenters' analyses contain a critical flaw. The
commenters' determination of safety rests on the presumption that under
real world conditions, events will always occur exactly as hypothesized
by the multiple assumptions in their assessment. For example, they
assume, despite all available evidence to the contrary, that children
will not be appreciably more sensitive to carbofuran's effects than
adults. They assume that carbofuran's effects will be highly
reversible, and that children will be uniformly sensitive, such that
the effects will be adequately accounted for by the assumption of a
150-minute half-life. They further assume that there will be no carry
over effect from the preceding day's exposures for infants. They assume
that the cancellation of use on alfalfa will reduce carbofuran residues
in milk by over 70%. They assume that residues will decrease between 19
and 23% as a result of the buffer requirements on the September 2008
label, even though the label does not require the use of all of the
recommended ``best management practices'' (e.g., no language regarding
swath displacement), and applicators do not universally use such
practices in the absence of any requirement. They assume that average
ground water pH adequately characterizes the temporal and spatial
heterogeneity common in most areas, despite the available evidence to
the contrary. Finally, they assume that PCT in watersheds will never
exceed 5% CT, despite varying pest pressures, consultant
recommendations, and individual grower decisions. Leaving aside that
EPA believes most, if not all of these assumptions are not supported by
the available evidence, as described throughout this final rule, the
probability of all these assumptions always simultaneously holding true
under real world conditions is unreasonably low, and certainly does not
approach the degree of certainty necessary for EPA to conclude that
children's exposures will be safe.
    Determining whether residues will be safe for U.S. children is not
a theoretical paper exercise; it cannot suffice to hypothesize a unique
set of circumstances that make residues ``fit in the box.'' There must
be a reasonable certainty that under the variability that exists under
real world conditions, exposures will be ``safe.'' EPA's assessments
incorporate a certain degree of conservatism precisely to account for
the fact that assumptions must be made that may not prove accurate.
This consideration is highly relevant for carbofuran, because as
refined as EPA's assessments are, areas of uncertainty remain with
regard to carbofuran's risk potential. For example, a recent
epidemiological study reported that 45% of maternal and cord blood
samples in a cohort of New York City residents of Northern Manhattan
and the South Bronx between 2000 and 2004, contained low, but
measurable residues of carbofuran (Ref. 118). The Agency is currently
unable to account for the source of such sustained exposures at this
frequency.
    A further consideration is that the risks of concern are acute
risks to children. For acute risks, the higher values in a
probabilistic risk assessment are often driven by relatively high
values in a few exposures rather than relatively lower values in a
greater number of exposures. This is due to the fact that an acute
assessment looks at a narrow window of exposure where there are
unlikely to be a great variety of consumption sources. Thus, to the
extent that there is a high exposure it will be more likely due to a
high residue value in a single consumption event. Additionally
worrisome in this regard is that carbofuran is a highly potent (i.e.,

has a very steep dose-response curve), acute toxicant, and therefore
any aPAD exceedances are more likely to have greater significance in
terms of the potential likelihood of actual harm.
    In sum, these results strongly support EPA's conclusion that
aggregate exposures to carbofuran are not safe.

IX. Procedural Matters

A. When Do These Actions Become Effective?

    The revocations of the tolerances for all commodities will become
effective December 31, 2009. EPA had proposed to establish an extended
effective date for artichokes and sunflower seed; however, EPA
ultimately agrees with those commenters who raised concern that
continuance of use for an additional year on these crops would be
inconsistent with the acute risks that carbofuran poses to children.
Accordingly, the revocation for tolerances on these two crops will now
be effective December 31, 2009. The Agency has set the effective date
in December because this is the quickest time frame in which the
decision could be practically implemented, given that some additional
time will be necessary to allow the process applicable to stay requests
to be completed. In addition, this time frame ensures that growers will
have a reasonable amount of time to make reasoned decisions about their
pest management strategies, and to exhaust any stocks of carbofuran
currently in their possession.
    Any commodities listed in this rule treated with the pesticide
subject to this rule, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(l)(5).
Under this section, any residues of these pesticides in or on such food
shall not render the food adulterated so long as it is shown to the
satisfaction of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA,
and
    2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates when the
pesticide was applied to such food.

B. Request for Stay of Effective Date

    A person filing objections to this final rule may submit with the
objections a petition to stay the effective date of this final rule.
Such stay petitions must be received by the Hearing Clerk on or before
July 14, 2009. A copy of the stay request filed with the Hearing Clerk
shall be submitted to the Office of Pesticide Programs Docket Room. A
stay may be requested for a specific time period or for an indefinite
time period. The stay petition must include a citation to this final
rule, the length of time for which the stay is requested, and a full
statement of the factual and legal grounds upon which the petitioner
relies for the stay.
    EPA received comments asserting that a hearing would definitely be
requested, and requesting a stay pending resolution of that hearing.
    Until EPA has published its final rule, any request for a stay is
purely speculative. EPA is only authorized to issue a stay of the
regulation, ``if after issuance of such regulation or order, objections
are filed with respect to such regulation...'' 21 U.S.C. 346a(g)(1). No
objections have been filed, nor could they be until EPA publishes its
final rule. Further, no demonstration has yet been made that any
hearing is warranted, nor indeed, could the commenters have done so at
this stage of the tolerance revocation process. See, 40 CFR 178 Subpart
B. EPA's regulations require all parties who request a stay to justify
the request with a statement of the factual and legal grounds upon
which the petitioner relies. To the extent the commenters still wish to
seek a stay of EPA's final rule, they will have the opportunity to do
so, as discussed above.
    In determining whether to grant a stay, EPA will consider the
criteria set out in the Food and Drug Administration's regulations
regarding stays of administrative proceedings at 21 CFR 10.35. Under
those rules, a stay will be granted if it is determined that:
    (1) The petitioner will otherwise suffer irreparable injury;
    (2) The petitioner's case is not frivolous and is being pursued in
good faith;
    (3) The petitioner has demonstrated sound public policy grounds
supporting the stay;
    (4) The delay resulting from the stay is not outweighed by public
health or other public interests.
    Under FDA's criteria, EPA may also grant a stay if EPA finds such
action is in the public interest and in the interest of justice.
    Any person wishing to comment on any stay request may submit such
comments and objections to a stay request to the Hearing Clerk, on or
before July 29, 2009. Any subsequent decisions to stay the effect of
this order, based on a stay request filed, will be published in the
Federal Register, along with EPA's response to comments on the stay
request.

X. Are The Agency's Actions Consistent With International Obligations?

    The tolerance revocations in this final rule are not discriminatory
and are designed to ensure that both domestically-produced and imported
foods meet the food safety standard established by the FFDCA. The same
food safety standards apply to domestically produced and imported
foods.
    EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S.
tolerances and in reassessing them. MRLs are established by the Codex
Committee on Pesticide Residues, a committee within the Codex
Alimentarius Commission, an international organization formed to
promote the coordination of international food standards. It is EPA's
policy to harmonize U.S. tolerances with Codex MRLs to the extent
possible, provided that the MRLs achieve the level of protection
required under FFDCA. EPA's effort to harmonize with Codex MRLs is
summarized in the tolerance reassessment section of individual
Reregistration Eligibility Decision documents. EPA has developed
guidance concerning submissions for import tolerance support (65 FR
35069, June 1, 2000) (FRL-6559-3). This guidance will be made available
to interested persons. Electronic copies are available on the internet
at http://www.epa.gov/. On the Home Page select ``Laws, Regulations,
and Dockets,'' then select Regulations and Proposed Rules and then look
up the entry for this document under ``Federal Register--Environmental
Documents.'' You can also go directly to the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.

XI. Statutory and Executive Order Reviews

    In this final rule, EPA is revoking specific tolerances established
under FFDCA section 408. The Office of Management and Budget (OMB) has
exempted tolerance regulations from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this final rule has been exempted from review under Executive
Order 12866, this final 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), which both apply to regulation actions reviewed under Executive
Order 12866. 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., or 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). Nor
does it require any special considerations as required by Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994). 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).
    In addition, the Agency has determined that this action will not
have a substantial direct effect on States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999). This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this final rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). This final rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this final rule.
    The Regulatory Flexibility Act (RFA) 5 USC 601 et.seq, generally
requires an agency to prepare a regulatory flexibility analysis of any
rule subject to notice and comment rulemaking requirements under the
Administrative Procedures Act or any other statute. This is required
unless the agency certifies that the rule will not have a significant
economic impact on a substantial number of small entities. Small
entities include small businesses, small organizations, and small
governmental jurisdictions. The Agency has determined that no small
organizations or small governmental jurisdictions are impacted by
today's rulemaking. For purposes of assessing the impacts of today's
determination on businesses, a small business is defined either by the
number of employees or by the annual dollar amount of sales/revenues.
The level at which an entity is considered small is determined for each
North American Industry Classification System (NAICS) code by the Small
Business Administration (SBA). Farms are classified under NAICS code
111, Crop Production, and the SBA defines small entities as farms with
total annual sales of $750,000 or less.
    The Agency has examined the potential effects today's final rule
may have on potentially impacted small businesses. EPA prepared an
analysis for the proposal and certified that its proposed rule would
not have a significant economic impact on a substantial number of small
entities. EPA received no comments on its analysis or certification.
Based on its analysis, EPA concludes that the Agency can certify that
revoking the food tolerances for carbofuran will not have a significant
economic impact on a substantial number of small entities for alfalfa,
artichoke, banana, chili pepper, coffee, cotton, cucurbits (cucumber,
melons, pumpkin, and squash), grape, grains (barley, flax, oats, and
wheat), field corn, potato, soybean, sorghum, sugarbeet, sugarcane,
sunflower, and sweet corn. Even in a worst-case scenario, in which a
grower obtains income only from a single crop and his/her entire
acreage is affected, the impact generally amounts to less than 2% of
gross income and would be felt by fewer than 3% of affected small
producers. Estimates of impacts to corn growers were refined to account
for the sporadic nature of need for carbofuran while still maintaining
some assumptions that would bias the estimates upward. Refined
estimates were also made for artichoke and sunflower, which consider
the diversity in growers' revenue. The largest impact may be felt by
artichoke growers, with impacts as high as 5% of gross revenue, but
fewer than five growers are likely to be affected. Moreover, as the
registrant has voluntarily cancelled the use of carbofuran on
artichokes, any impact is more properly traced to the registrant's
decision to cancel the registration, than to the revocation of the
tolerance. EPA could not quantify the impacts to banana, sugarcane, and
sweet corn producers, but the number of impacted farms is less than 2%
of the farms subject to the action. Additional detail on the analyses
EPA conducted in support of this certification can be found in
Reference 85.

XII. 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
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 the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

XIII. References

    The following is a list of the documents that are specifically
referenced in this final rule and placed in the docket that was
established under Docket ID number EPA-HQ-OPP-2005-0162. The public
docket includes information considered by EPA in developing this final
rule, such as the documents specifically referenced in this action that
are listed in this unit, documents that are referenced in the documents
that are in the docket, any public comments received, and other
information related to this action. For information on accessing the
docket, refer to the ADDRESSES unit at the beginning of this document.
    1. Abou-Donia, M.B., Khan, W.A., Dechkovskaia, A.M., Goldstein,
L.B., Bullman, S.L., Abdel-Rahman, A., In utero exposure to nicotine
and chlorpyrifos alone, and in combination produces persistent
sensorimotor deficits and Purkinje neuron loss in the cerebellum of
adult offspring rats. Arch Toxicol. 2006 Sep;80(9):620-31. Epub 2006
Feb 16.
    2. Abramovitch, R., Tavor, E., Jacob-Hirsch, J., Zeira, E.,
Amariglio, N., Pappo, O., Rechavi, G., Galun, E., Honigman, A., A
pivotal role of cyclic AMP-responsive element binding protein in tumor
progression. Cancer Research. 2004 Feb 15;64(4):1338-46.
    3. Acute oral (gavage) dose range-finding study of cholinesterase
depression from carbofuran technical in juvenile (day 11) rats.
Hoberman, 2007. MRID 47143703 (unpublished FMC study) EPA-HQ-OPP-2007-
1088-0062.

    4. Acute oral (gavage) time course study of cholinesterase
depression from carbofuran technical in adult and juvenile (day 11
postpartum) rats. Hoberman, 2007. MRID 47143704 (unpublished FMC study)
EPA-HQ-OPP-2007-1088-0063.
    5. Acute Dose-Response Study of Carbofuran Technical Administered
by Gavage to Adult and Postnatal Day 11 Male and Female CD (Sprague-
Dawley) Rats: Tyl and Myers. 2005. MRID. 46688914.
    6. Aller, L., Bennet, T., Lehr, J.H., Petty, R.J., and Hackett, G.
1987. DRASTIC: A standardized system for evaluating groundwater
pollution potential using hydrogeologic setting. EPA/600/2-87/035.
Robert S. Kerr Environmental Research Laboratory, U.S. Environmental
Protection Agency, 622 pp.
    7. An In-Depth Investigation to Estimate Surface Water
Concentrations of Carbofuran within Indiana Community Water Supplies.
Performed by Waterborne Environmental, Inc., Leesburg, VA, Engel
Consulting, and Fawcett Consulting. Submitted by FMC. Corporation,
Philadelphia, PA. WEI No 528.01, FMC Report No. PC-0378. MRID 47221603.
EPA-HQ-OPP-2007-1088-0023.
    8. An Investigation into the Potential for Carbofuran Leaching to
Ground Water Based on Historical and Current Use Practices. Submitted
by FMC. Corporation, Philadelphia, PA. Report No. PC-0363. MRID
47221602. EPA-HQ-OPP-2007-1088-0022.
    9. An Investigation into the Potential for Carbofuran Leaching to
Ground Water Based on Historical and Current Use Practices:
Supplemental Report on Twenty-one Additional States. Submitted by FMC
Corporation, Philadelphia, PA. Report No. PC-0383. MRID 47244901. EPA-
HQ-OPP-2007-1088-0025.
    10. Angier, Jonathan. 2005. Tier 2 Drinking Water Assessment for
Aldicarb and its Major Degradates Aldicarb Sulfoxide and Aldicarb
Sulfone. (DP 316754) Internal EPA Memorandum to Robert McNally dated
May 10, 2005.
    11. Benchmark dose analysis of cholinesterase inhibition data in
neonatal and adult rats (MRID no. 46688914) following exposure to
carbofuran (A.Lowit, 1/19/06, D325342, TXR no. 0054034). EPA-HQ-OPP-
2007-1088-0045.
    12. Benjamins, J.A., and McKhann, G.M. 1981. Development,
regeneration, and aging of the brain. In: Basic Neurochemistry. 3rd
edition. Edited by Siegel, G.J., Albers, R.W., Agranoff, B.W., and
Katzman, R. Little, Brown and Co., Boston. pp 445-469;.
    13. Best Management Practices to Reduce Carbofuran Losses to Ground
And Surface Water. Submitted by FMC. Corporation, Philadelphia, PA.
Report No. PC-0362. MRID 47279201. EPA-HQ-OPP-2005-0162-0464.
    14. Bretaud, S., Toutant, J.P., Saglio, P. 2000. Effects of
carbofuran, diuron, and nicosulfuron on acetylcholinesterase activity
in goldfish (Carassius auratus). Ecotoxicol Environ Saf. 2000 Oct;
47(2):117-24.
    15. California Department of Pesticide Regulation. Risk
Characterization Document for Carbofuran. January 23, 2006. 219 pgs.
Available at: http://www.cpdr.ca.gov/docs/risk/red/carbofuran.pdf.
    16. Carbofuran Acute Aggregate Dietary (Food and Drinking Water)
Exposure and Risk Assessments for the Reregistration Eligibility
Decision (T. Morton, 7/22/08, D351371). EPA-HQ-OPP-2005-0162-0508.
    17. Carbofuran Environmental Risk Assessment and Human Drinking
Water Exposure Assessment for IRED. March 2006. EPA-HQ-OPP-2005-0162-
0080.
    18. Carringer, 2000. Carbamate Market Basket Survey. Reviewed by S.
Piper, D267539, 8/8/02. (MRID 45164701 S. Carringer, 5/12/00).
    19. Carbofuran. HED Revised Risk Assessment for the Reregistration
Eligibility Decision (RED) Document (Phase 6). (PC 090601) D 330541,
July 26, 2006. EPA-HQ-OPP-2005-0162-0307.
    20. Carbofuran. HED Revised Risk Assessment for the Notice of
Intent to Cancel . (PC 090601) D 347038, January 2007. EPA-HQ-OPP-2007-
1088-0034.
    21. Cholinesterase depression in juvenile (day 11) and adult rats
following acute oral (gavage) dose of carbofuran technical. Hoberman,
2007. MRID 47143705 (unpublished FMC study). EPA-HQ-OPP-2007-1088-0066.
    22. Context Document for Carbofuran Risk Assessment Issues not
Specifically Addressed in the FIFRA SAP Charge Questions (M. Panger, C.
Salice, R. David Jones, E. Odenkirchen, I. Sunzenauer, 1/08 D348292).
EPA-HQ-OPP-2007-1088-0071.
    23. Crumpton T.L., Seidler, F.J., Slotkin, T.A. Developmental
neurotoxicity of chlorpyrifos in vivo and in vitro: Effects on nuclear
transcription factors involved in cell replication and differentiation.
Brain Research. 2000 Feb 28;857(1-2):87-98.
    24. Data Evaluation Record for Acute dose-response study of
carbofuran technical administered by gavage to adult and postnatal day
11 male and female CD[reg](Sprague-Dawley) rats. MRID 46688914. EPA-HQ-
OPP-2007-1088-0045.
    25. Data Evaluation Record for Cholinesterase depression in
juvenile (day 11) and adult rats following acute oral (gavage) dose of
carbofuran technical. MRIDs 47143703, 47143704 and 47143705. EPA-HQ-
OPP-2005-0162-0468.
    26. Davison, A.N. and Dobbing, J. 1966. Myelination as a vulnerable
period in brain development. British Medical Bulletin. 22:40-44.
    27. Dobbing, J. and Smart, J.L. (1974) Vulnerability of developing
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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: May 11, 2009.
Debra Edwards,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I be 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 180.254 is amended by revising the tables in paragraphs (a)
and (c) to read as follows:

Sec.  180.254  Carbofuran; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                  Parts per  Expiration/
                    Commodity                      million    Revocation
                                                    (ppm)        date
------------------------------------------------------------------------
Alfalfa, forage (of which no more than 5 ppm are         10     12/31/09
 carbamates)....................................
Alfalfa, hay (of which no more than 20 ppm are           40     12/31/09
 carbamates)....................................
Banana..........................................        0.1     12/31/09
Barley, grain (of which not more than 0.1 ppm is        0.2     12/31/09
 carbamates)....................................
Barley, straw (of which no more than 1.0 ppm is         5.0     12/31/09
 carbamates)....................................
Beet, sugar, roots..............................        0.1     12/31/09
Beet, sugar, tops (of which no more than 1 ppm            2     12/31/09
 is carbamates).................................
Coffee, bean, green.............................        0.1     12/31/09
Corn, forage (of which no more than 5 ppm are            25     12/31/09
 carbamates)....................................
Corn, grain (including popcorn) (of which no            0.2     12/31/09
 more than 0.1 ppm is carbamates)...............
Corn, stover (of which no more than 5 ppm are            25     12/31/09
 carbamates)....................................
Corn, sweet, kernel plus cob with husks removed         1.0     12/31/09
 (of which no more than 0.2 ppm is carbamates)..
Cotton, undelinted seed (of which no more than          1.0     12/31/09
 0.2 ppm is carbamates).........................
Cranberry (of which no more than 0.3 ppm is             0.5     12/31/09
 carbamates)....................................
Cucumber (of which not more than 0.2 ppm is             0.4     12/31/09
 carbamates)....................................
Grape (of which no more than 0.2 ppm is                 0.4     12/31/09
 carbamates)....................................
Grape, raisin (of which no more than 1.0 ppm is         2.0     12/31/09
 carbamate......................................
Grape, raisin, waste (of which no more than 3.0         6.0     12/31/09
 ppm is carbamates..............................
Melon (of which not more than 0.2 ppm is                0.4     12/31/09
 carbamates)....................................
Milk (of which no more than 0.02 ppm is                 0.1     12/31/09
 carbamates)....................................
Oat, grain (of which not more than 0.1 ppm is           0.2     12/31/09
 carbamates)....................................
Oat, straw (of which not more than 1.0 ppm is           5.0     12/31/09
 carbamates)....................................
Pepper (of which no more than 0.2 ppm is                  1     12/31/09
 carbamates)....................................
Potato (of which no more than 1 ppm is                    2     12/31/09
 carbamates)....................................
Pumpkin (of which not more than 0.6 ppm is              0.8     12/31/09
 carbamates)....................................
Rice, grain.....................................        0.2     12/31/09
Rice, straw (of which no more than 0.2 ppm is             1     12/31/09
 carbamates)....................................
Sorghum, forage (of which no more than 0.5 ppm            3     12/31/09
 is carbamates).................................
Sorghum, grain, grain...........................        0.1     12/31/09
Sorghum, grain, stover (of which no more than             3     12/31/09
 0.5 ppm is carbamates).........................
Strawberry (of which no more than 0.2 ppm is            0.5     12/31/09
 carbamates)....................................
Soybean (of which not more than 0.2 ppm is              1.0     12/31/09
 carbamates)....................................
Soybean, forage (of which not more than 20.0 ppm       35.0     12/31/09
 are carbamates)................................
Soybean, hay (of which not more than 20.0 ppm          35.0     12/31/09
 are carbamates)................................
Squash (of which not more than 0.6 ppm is               0.8     12/31/09
 carbamates)....................................
Sugarcane, cane.................................        0.1     12/31/09
Sunflower, seed (of which not more than 0.5 ppm         1.0     12/31/09
 is carbamates).................................
Wheat, grain (of which not more than 0.1 ppm is         0.2     12/31/09
 carbamates)....................................
Wheat, straw (of which not more than 1.0 ppm is         5.0     12/31/09
 carbamates)....................................
------------------------------------------------------------------------

* * * * *
    (c) * * *

------------------------------------------------------------------------
                                                  Parts per  Expiration/
                    Commodity                      million    Revocation
                                                    (ppm)        date
------------------------------------------------------------------------
Artichoke, globe (of which not more than 0.2 ppm        0.4     12/31/09
 is carbamates).................................
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-11396 Filed 5-12-09; 4:15 pm]

BILLING CODE 6560-50-S