--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                                      0.0002     0.000884        440     0.001345        670     0.002271      1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------

    While the registrant has attempted to address drinking water
exposure from ground water sources by including on current carbofuran
product labeling an advisory statement warning growers against
application in vulnerable areas, this language does not prohibit use in
such areas. In addition, EPA does not believe that the available
information demonstrates that even the additional restrictions that FMC
included on its labels submitted in May, 2008 would adequately mitigate
the risk of contaminating all vulnerable ground water (Refs. 18 and
54). For example, those restrictions were based on the use of a
particular methodology to evaluate the characteristics in the site used
in the PGW study in the Delmarva Penninsula. Using that as a surrogate
to identify sites with vulnerability to ground water contamination, FMC
identified counties that had higher vulnerability scores than the site
used for the PGW study in the Delmarva Penninsula, and proposed label
restrictions to preclude use in such areas. While EPA agrees in
principle that precluding use in sites vulnerable to leaching can
mitigate the risks, and even presuming that the methodology used by FMC
adequately identifies those sites, sites less vulnerable than the PGW
site would still be vulnerable to contamination, and the proposed
restrictions in no way addressed the less sensitive, but still
vulnerable, sites (Refs. 18 and 54). Accordingly, EPA continues to
believe that its assessment of drinking water from groundwater sources
based on current labels is a realistic assessment of potential
exposures to those portions of the population consuming drinking water
from shallow wells in highly vulnerable areas.
    b. Exposure from drinking water derived from surface water sources.
EPA's evaluation of environmental drinking water concentrations of
carbofuran from surface water, as with its evaluation of groundwater,
takes into account the results of both surface water monitoring and
modeling.
    Data compiled in 2002 by EPA's Office of Water show that carbofuran
was detected in treated drinking water at a few locations. Based on
samples collected from 12, 531 ground water and 1,394 surface water
source drinking water supplies in 16 states, carbofuran was found at no
public drinking water supply systems at concentrations exceeding 40 ppb
(the MCL). Carbofuran was found at one public ground water system at a
concentration of greater than 7 ppb and in two ground water systems and
one surface water public water system at concentrations greater than 4
ppb (measurements below this limit were not reported). Sampling is
costly and is conducted typically four times a year or less at any
single drinking water facility. The overall likelihood of collecting
samples that capture peak exposure events is, therefore, low. For
chemicals with acute risks of concern, such as carbofuran, higher
concentrations and resulting risk is primarily associated with these
peak events, which are not likely to be captured in monitoring unless
the sampling rate is very high.
    Unlike drinking water derived from private groundwater wells,
public water supplies (surface water or ground water source) will
generally be treated before it is distributed to consumers. An
evaluation of laboratory and field monitoring data indicate that
carbofuran may be effectively removed (60 - 100%) from drinking water
by lime softening and activated carbon; other treatment process are
less effective in removing carbofuran (Ref. 63). The detections between
4 and 7 ppb, reported above, represent concentrations in samples
collected post-treatment. As such, these levels are of particular
concern to the Agency. An infant who consumes a single 8 ounce serving
of water with a concentration of 4 ppb, as detected in the monitoring,
would receive 121% of the aPAD. An infant who consumes a single 8 ounce
serving of water with the higher detected concentration of 7 ppb, as
detected in the monitoring, would receive 210% of the aPAD.
    To further characterize carbofuran concentrations in surface water
(e.g., streams or rivers) that may drain into drinking water
reservoirs, EPA analyzed the extensive source of national water
monitoring data for pesticides, the United States Geological Survey
National Water Quality Assessment (USGS NAWQA) program. The NAWQA
program focuses on ambient water rather than on drinking water sources,
is not specifically targeted to the high use area of any specific
pesticide, and is sampled at a frequency (generally weekly or bi-weekly
during the use season) insufficient to provide reliable estimates of
peak pesticide concentrations in surface water. For example,
significant fractions of the data may not be relevant to assessing
exposure from carbofuran use, as there may be no use in the basin above
the monitoring site. Unless ancillary usage data are available to
determine the amount and timing of the pesticide applied, it is
difficult to determine whether non-detections of carbofuran were due to
a low tendency to move to water or from a lack of use in the basin. The
program, rather, provides a good understanding on a national level of
the occurrence of pesticides in flowing water bodies that can be useful
for screening assessments of potential drinking water sources. A
detailed description of the pesticide monitoring component of the NAWQA
program is available on the NAWQA Pesticide National Synthesis Project
(PNSP) web site (http://ca.water.usgs.gov/pnsp/).
    A summary of the first cycle of NAWQA monitoring from 1991 to 2001
indicates that carbofuran was the most frequently detected carbamate
pesticide in streams and ground water in agricultural areas. Overall,
where

carbofuran was detected, these non-targeted monitoring results
generally found carbofuran at levels below 0.5 ppb. In the NMC
assessment, EPA summarized NAWQA monitoring for carbofuran between 1991
and 2004. Maximum surface-water concentrations exceeded 1 ppb in
approximately nine agricultural watershed-based study units, with
detections in the sub-ppb range reported in additional watersheds (Ref.
63). The highest concentrations of carbofuran are reported from at a
sampling station on Zollner Creek, in Oregon. Zollner Creek, located in
the Molalla-Pudding sub-basin of the Willamette River, is not directly
used as a drinking water source. This creek is a low-order stream and
its watershed is small (approximately 40 km2) and intensively farmed,
with a diversity of crops grown, including plant nurseries. USGS
monitoring at that location from 1993 to 2006 detected carbofuran
annually in 40-100 % of samples. Although the majority of
concentrations detected there are also in the sub-part per billion
range, concentrations have exceeded 1 ppb in 8 of the 14 years of
sampling. The maximum measured concentration was 32.2 ppb, observed in
the spring of 2002. The frequency of detections generally over a 14-
year period suggests that standard use practices rather than
aberrational misuse incidents in the region are responsible for high
concentration levels at this location.
    While available monitoring from other portions of the country
suggests that the circumstances giving rise to high concentrations of
carbofuran may be rare, overall, the national monitoring data indicate
that EPA cannot dismiss the possibility of detectable carbofuran
concentrations in some surface waters under specific use and
environmental conditions. Even given the limited utility of the
available monitoring data, there have been relatively recent measured
concentrations of carbofuran in surface water systems at levels above 4
ppb (concentrations of 4-7 ppb would result in exposures of 121-210% of
the aPAD for an infant consuming 8 oz of water) and levels of
approximately 1 to 30 ppb measured in streams representative of those
in watersheds that support drinking water systems (Ref. 63). Based on
this analysis, and since monitoring programs have not been sampling at
a frequency sufficient to detect daily-peak concentrations that are
needed to assess carbofuran's acute risk, the available monitoring
data, in and of themselves, are not sufficient to establish the risks
posed by carbofuran in surface drinking water are below thresholds of
concern. Nor can this data be reasonably used to establish a lower
bound of potential carbofuran risk through this route of exposure.
    To further characterize carbofuran risk through drinking water
derived from surface water sources, EPA modeled estimated daily
drinking water concentrations of carbofuran using PRZM to simulate
field runoff processes and EXAMS to simulate receiving water body
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. 18 and 54) 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 Cumulative Assessment (Ref. 63). 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. 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 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. Modeling was conducted at a range of application rates and
included adjustments to reflect different regional levels for
agricultural intensity, resulting in estimated 1-in-10-year (peak)
concentrations of 0.11-75 ppb (Refs. 5 and 36). For corn, carbofuran
concentration estimates assuming different rates and regional percent
cropped area (PCA) factors reflective of corn intensity nationally
resulted in a range of peak concentrations of 4 - 26 ppb. For the
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. 3, 13 and 47).
Peak concentrations for these distributions ranged from 3.2 to 168 ppb
(excluding use on bananas), with the corn use at 26 ppb (Refs. 3 and
47).
    EPA has 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 and application practices that assume the only use
of carbofuran in a watershed is on corn. Simulations included those
specific to control European corn borer, a rescue treatment for corn
rootworm, and an in-furrow application at plant. The assessment also
included estimates resulting from treatment at the maximum label rate,
for comparative purposes. The peak concentrations estimated ranged from
3.9 to 16.6 ppb for the refined analyses, compared to 32.9 ppb at the
maximum application rate (Ref. 4). The range of 3.9 to 16.6 ppb is
approximately 1 to 4 times the values of the 4 ppb detected in finished
water from a surface water drinking plant, as summarized previously,
and approximately twofold to tenfold lower than the maximum peak
concentration of 32.2 ppb reported in the USGS-NAWQA data set.
    Additional refined modeling assessments were based on a proposed
label submitted by FMC in May 2008. The refinements focused on two uses
currently allowed on the existing label that would have remained under
the withdrawn label: a corn rootworm rescue treatment, evaluated at 7
representative sites, and an at-plant

treatment for melons evaluated at 4 additional sites. EPA developed 5
additional corn scenarios 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, these assessments focused on the
corn rescue treatment (Ref. 4). Peak concentrations for the corn rescue
treatments simulated for Illinois, Iowa, Indiana, Kansas, Minnesota,
Nebraska, and Texas ranged from 16.6 - 36.7 ppb. For refinement of
estimates for the other use, melons, EPA developed 3 additional melon
scenarios representing states with extensive carbofuran usage at
locations more vulnerable than most in each state in areas melons are
grown. EPA used measured rainfall values and a wide row spacing to
simulate an application rate less than half of what is allowed as the
maximum rate for melons (0.65 versus 1.94 lb/A). Peak concentrations
resulting from a single ground application of carbofuran at plant in
Florida, Michigan, Missouri, and New Jersey resulted in peak
concentrations from 4.2 - 24.4 ppb (Id.). Additional details on these
assessments can be found at Ref. 4. Consistent with the analysis
summarized above these predicted carbofuran water concentrations are
similar to 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. 13). 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. 42). 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 pathway for contamination of surface water. 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 two 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 and 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 current label as well as scenarios comparable to the
uses on FMC's proposed label of May 2008. Exposures from all modeled
scenarios substantially exceeded EPA's level of concern (Ref. 12). For
example, an Illinois corn scenario, assuming 2 foliar applications at a
typical 1-lb a.i. per acre use rate, estimated a 1-in-10-year peak
carbofuran water concentration of 26 ppb. Exposures at the 99.9th
percentile based on this modeled distribution ranged from 860% of the
aPAD for youths 13-19 to greater than 10,000% of the aPAD for infants.
This scenario is intended to be representative of highly vulnerable
sites on which corn could be grown on a national basis, and is used as
a screen for corn on a national basis. Similarly, exposures based on an
Idaho potato scenario, and using a 3 lb a.i. acre rate, ranged from
230% of the aPAD for children 6-12 to 890% of the aPAD for infants,
with a1-in-10-year peak carbofuran concentration of 10 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 Refs. 4, 12 and 47.
    Table 8 below presents the results of one of EPA's refined exposure
analyses that addresses a use comparable to one in FMC's proposed May
2008 label. This example 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 Hydrologic
Unit Code 8-sized basin in the United States. (The U.S. Geological
Survey has classified all watersheds in the US 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 Refs. 4, 12 and 47.

            Table 8--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     0.000444        590     0.001236      1,650     0.002912      3,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                                  0.000075     0.000190        250     0.000517        690     0.001267      1,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                                  0.000075     0.000177        240     0.000473        630     0.001144      1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------

Children 6-12 years old                                                 0.000075     0.000122        160     0.000329        440     0.000801      1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                                                     0.0002     0.000091         45     0.000255        130     0.000671        340
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                                                    0.0002     0.000118         60     0.000313        160     0.000766        380
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                                      0.0002     0.000125         60     0.000307        150     0.000671        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 460 to 102% 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.
    FMC has criticized EPA's assessment for failing to account more
fully for the percent of the crop treated (PCT) in its modeling.
Uncertainty associated with PCT assumptions can be a major factor in
EPA's drinking water exposure assessment for surface-water sources.
Estimates of the percent of major crops (for example, corn) that are
treated with pesticides are available at the state level, but are
generally not available on a smaller scale suitable for estimating
drinking water exposure in a watershed. In addition, the PCT should be
assessed at a watershed-scale, aggregating all crops treated with the
pesticide in a watershed. If state-scale estimates are used to account
for PCT it will underestimate the risk for some of the drinking water
facilities in the state as the state-wide estimate represents an
average: values for individual facilities will be both lower and higher
than the state-wide estimate. In some cases, the underestimate can be
substantial if the application pattern tends to form cluster or pockets
of high usage. Insecticides like carbofuran are particularly prone to
this use pattern, as insect outbreaks often tend to be locally intense,
rather than widespread. In addition, marginal use practice changes in a
given watershed can substantially affect the percentage of the crop
treated, and such changes are effectively impossible to track. Without
data collected at a finer spatial scale, it is not possible to know
whether pesticide usage is evenly dispersed through the state or is
locally clustered. This results in large uncertainty in the drinking
water exposure assessments when percent crop treated is moderate or
low. Consequently, EPA does not typically include such information in
its surface-water exposure assessments.
    However, 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 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. 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 6-12 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 Refs. 12, 13 and 47.
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 aggregate exposures would still exceed
100% of the aPAD.
    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 are highly 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
are 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.
    Apparently FMC also has determined that some drinking water
facilities associated with surface source waters are vulnerable to
carbofuran exposure. In the now withdrawn labels FMC proposed to
require buffer zones around surface waters in certain locations of the
country, presumably to protect surface water. The proposed buffers were
for fields where soils were considered to be highly erodible. Buffers
were to be 66 feet wide 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. 55). 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.
    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. 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. Pesticide residues in water
fluctuate daily, seasonally, and yearly as a result of the timing of
the pesticide application, the vulnerability of the water supply to
pesticide loading through runoff, spray drift and/or leaching, and
changes in the weather. Concentrations are also affected by the method
of application, the location and characteristics of the sites where a
pesticide is used, the climate, and the type and degree of pest
pressure. Consequently, EPA conducted several estimates of aggregate
dietary risks by combining exposures from food and drinking water. All
of these estimates showed that aggregate exposures to carbofuran
residues are unsafe. 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 Refs. 12 and 13.
    Table 9 below reflects the results of aggregate exposures from food
and from drinking water derived from ground water in vulnerable areas
(i.e., from shallow wells associated with sandy soils and acidic
aquifers, such as are found in the Delmarva Peninsula). The estimates
range between 1,100% of the aPAD for adults, to over 10,000% of the
aPAD for infants.

                  Table 9--Results of Acute Dietary (Food and Water) Exposure Analysis Incorporating the Delmarva Ground Water 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     0.003799      5,100     0.006026      8,000     0.010011    >10,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                                  0.000075     0.001622      2,200     0.002740      3,700     0.004644      6,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                                  0.000075     0.001465      2,000     0.002414      3,200     0.004273      5,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 6-12 years old                                                 0.000075     0.001026      1,400     0.001715      2,300     0.002825      3,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                                                     0.0002     0.000813        410     0.001442        720     0.002921      1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                                                    0.0002     0.000958        480     0.001638        820     0.003091      1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                                      0.0002     0.000888        440     0.001351        680     0.002278      1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The peak concentration estimates in the Delmarva groundwater
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 38.5 ppb while maximum
values from a targeted ground water monitoring study at the same site
was 65 ppb, with studies at other sites having similar or higher peak
concentrations (Refs. 13 and 47). 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 22 ppb.
    Table 10 below presents the results of aggregate exposure from food
and derived from surface water using the Nebraska corn surface water
scenario. This table reflects the risks only for those people in
drinking 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 10--Results of Acute Dietary (Food and Water) Exposure Analysis Using the Nebraska Corn Surface Water 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     0.000448        600     0.001240      1,700     0.002899      3,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                                  0.000075     0.000200        270     0.000533        710     0.001326      1,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                                  0.000075     0.000187        250     0.000486        650     0.001190      1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 6-12 years old                                                 0.000075     0.000128        170     0.000336        450     0.000824      1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                                                     0.0002     0.000095         48     0.000264        130     0.000685        340
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                                                    0.0002     0.000122         61     0.000318        160     0.000785        390
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                                      0.0002     0.000129         65     0.000312        160     0.000689        340
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Typically, EPA's food and water exposure assessments 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 that it
might be appropriate to consider durations of exposure less than 24
hours. EPA has developed an analysis using information about external
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 information to estimate
the residual effects from carbofuran from previous exposures within the
day. The carbofuran analyses are described in the July 2008 aggregate
(dietary) memo (Ref. 12).
    EPA has used two approaches for considering the impact of rapid
reversibility on exposure estimates in the food and drinking water risk
assessments. EPA previously used these approaches in the cumulative
risk assessment of the NMC pesticides and/or risk assessments for other
NMC pesticides (e.g., methomyl and aldicarb) (Ref. 63).
    Incorporating eating occasion analysis and either the 150 minute or
300 minute recovery half life 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.
    The food analysis showed that over 70% of exposures at the top 0.2
percentile for children ages 1-2 and 3-5 are from a single eating event
of carbofuran indicating that carbofuran's food risk is not
substantively overstated. Moreover, when incorporating half-life to
recovery information, risks from summing exposures over 24 hours are
similar to those when incorporating half-life to recovery of 150 or 300
minutes. 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
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. 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 New Jersey melon
scenario, which estimated one of the lower exposure distributions,
aggregate exposures ranged from a low of 280% of the aPAD for infants,
based on a 150-minute half-life, to a high of 370% of the aPAD for
infants, based on a 300-minute half-life.
    The two approaches discussed above are 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 to carbofuran is indeed not
substantively overestimated using the current exposure models and the
24-hour approach. This is due to the fact that exposure to carbofuran
occurs predominantly through single eating events and not from multiple
events that occur throughout the day. 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.
    The result of all of these analyses clearly demonstrate 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. Based on the contribution from food alone,
dietary exposures to carbofuran exceed EPA's level of concern for all
of the more sensitive subpopulations of infants and children. In
addition, 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 groundwater 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 substantially more uncertainty
associated with these exposure estimates. Every sensitivity analysis
EPA has performed has shown that estimated exposures significantly
exceed EPA's level of concern for children. Although the magnitude of
the exceedance varies depending the level of conservatism in the
assessment, the fact that in each case, aggregate exposures from
dietary exposures of carbofuran fail to meet the FFDCA section 408
safety standard strongly corroborates EPA's conclusion that aggregate
exposures from all uses of carbofuran are not safe.

VII. When Do These Actions Become Effective?

    The Agency is proposing that the revocations of the tolerances for
all commodities except artichoke and sunflower seed become effective 60
days after a final rule is published. EPA is also proposing to
establish an extended effective date for artichokes and sunflower seed,
to allow growers of these crops additional time to transition to
alternative compounds. The revocation for these two tolerances will
become effective two years after a final rule or order is published.
The Agency believes that these revocation dates will allow users to
exhaust stocks of carbofuran currently in their possession. However, if
EPA is presented with information during the comment period on this
proposal that end-users may need additional time to utilize carbofuran
stocks currently in their possession, and that information is verified,
the Agency will consider extending the expiration date of the
tolerance. If you have comments regarding the effective date, or if you
have comments on how long it would take you to utilize the carbofuran
stocks currently in your possession, please submit comments as
described under SUPPLEMENTARY INFORMATION.
    Any commodities listed in this proposal treated with the pesticide
subject to this proposal, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as
established by FQPA. 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.

VIII. Are the Proposed Actions Consistent with International
Obligations?

    The tolerance revocations in this proposal 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 is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. 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/.

IX. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to revoke specific
tolerances established under FFDCA section 408. The Office of
Management and Budget (OMB) has exempted this type of action (e.g.,
tolerance revocation for which extraordinary circumstances do not
exist) from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this
proposed rule has been exempted from review under Executive Order 12866
due to its lack of significance, this proposed 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). This proposed 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); or OMB review or any other Agency action under
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). 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). Executive Order 13132 requires EPA to develop an
accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the 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.'' This proposed 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 proposed 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). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed 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 proposed rule.
    The Regulatory Flexibility Act (RFA) of 1980, as amended by the
Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 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 proposed rule
may have on potentially impacted small businesses. Based on this
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 (No SISNOSE) 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. 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 Ref. 49.

X. References

    EPA has established an official record for this rulemaking. The
official record includes all information considered by EPA in
developing this proposed rule including documents specifically
referenced in this action and listed below, any public comments
received during an applicable comment period, and any other information
related to this action, including any information claimed as CBI. This
official record includes all information physically CAlocated in docket
ID number EPA-HQ-OPP-2005-0162, as well as any documents that are
referenced in the documents listed below or in the docket. The public
version of the official record does not include any information claimed
as CBI.
    1. 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.
    2. 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.
    3. Additional chemographs for potatoes and cucurbits for drinking
water exposure assessment in support of the reregistration of
carbofuran (PC Code 090601) (R. David Jones, 10/23/07 D345729). EPA-HQ-
OPP-2005-0162-0486.
    4. Additional refinements of the drinking water exposure assessment
for the use of carbofuran on corn and melons (PC code 090601)(R. David
Jones, 06/2008 D353714).
    5. 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.
    6. 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.
    7. 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.
    8. 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.
    9. 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; Dobbing, J. and
Smart, J.L. (1974) Vulnerability of developing brain and behaviour.
British Medical Bulletin. 30:164-168; Davison, A.N. and Dobbing, J.
(1966) Myelination as a vulnerable period in brain development. British
Medical Bulletin. 22:40-44.

    10. 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.
    11. California Department of Pesticide Regulation. Risk
Characterization Document for Carbofuran. January 23, 2006. 219 pgs.
    12. Carbofuran Acute Aggregate Dietary (Food and Drinking Water)
Exposure and Risk Assessments for the Reregistration Eligibility
Decision (T. Morton, 7/22/08, D351371).
    13. Carbofuran Environmental Risk Assessment and Human Drinking
Water Exposure Assessment for IRED. March 2006. EPA-HQ-OPP-2005-0162-
0080.
    14. Carringer, 2000. Carbamate Market Basket Survey. Reviewed by S.
Piper, D267539, 8/8/02. (MRID 45164701 S. Carringer, 5/12/00).
    15. 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.
    16. Carbofuran. HED Revised Risk Assessment for the Notice of
Intent to Cancel. (PC 090601) D 347038, January 2007. EPA-HQ-OPP-2007-
1088-0034.
    17. 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.
    18. 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.
    19. 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.
    20. Data Evaluation Record for Cholinesterase depression in
juvenile (day 11) and adult rats following acute oral (gavage) dose of
carbofuran technical. MRID 47143705.
    21. Dose-time response modeling of rat brain AChE activity:
carbofuran gavage dosing 10/5/07 (Carbofuran-RatBrainDR.pdf) EPA-HQ-
OPP-2007-1088-0053.
    22. Dose-time response modeling of rat RBC-AChE activity:
carbofuran gavage dosing 10/23/07 (RatRBC--DR.pdf). EPA-HQ-OPP-2007-
1088-0029.
    23. EPA Response to the Transmittal of Meeting Minutes of the FIFRA
Scientific Advisory Panel Meeting Held February 5-8 2008 on the
Agency's Proposed Action under FIFRA 6(b) Notice of Intent to Cancel
Carbofuran (E.Reaves, A. Lowit, J. Liccione 7/2008 D352315).
    24. Estimated Drinking Water Concentrations (email communication
D.Young to D.Drew, 3/8/06).
    25. FIFRA SAP (1998) ``A set of Scientific Issues Being Considered
by the Agency in Connection with Proposed Methods for Basin-scale
Estimation of Pesticide Concentrations in Flowing Water and Reservoirs
for Tolerance Reassessment.'' Final Report from the FIFRA Scientific
Advisory Panel Meeting of July 29-30, 1998 (Report dated September 2,
1998). Available at: http://www.epa.gov/scipoly/sap/meetings/1998/july/
final1.pdf.
    26. FIFRA SAP (1999) ``Sets of Scientific Issues Being Considered
by the Environmental Protection Agency Regarding Use of Watershed-
derived Percent Crop Areas as a Refinement Tool in FQPA Drinking Water
Exposure Assessments for Tolerance Reassessment.'' Final Report from
the FIFRA Scientific Advisory Panel Meeting of February 5-7, 2002
(Report dated May 25, 1999). SAP Report 99-03C. Available at: http://
www.epa.gov/scipoly/sap/meetings/1999/may/final.pdf.
    27. FIFRA SAP. (2002). ``Methods Used to Conduct a Preliminary
Cumulative Risk Assessment for Organophosphate Pesticides.'' Final
Report from the FIFRA Scientific Advisory Panel Meeting of February 5-
7, 2002 (Report dated March 19, 2002). FIFRA Scientific Advisory Panel,
Office of Science Coordination and Policy, Office of Prevention,
Pesticides and Toxic Substances, U.S. Environmental Protection Agency.
Washington, DC. SAP Report 2002-01.
    28. FIFRA Science Advisory Panel (SAP). 2005a. ``Final report on N-
Methyl Carbamate Cumulative Risk Assessment: Pilot Cumulative
Analysis.'' Final Report from the FIFRA Scientific Advisory Panel
Meeting of February , 2005 (Report dated September 2, 1998). Available
at: http://www.epa.gov/scipoly/sap/2005/february/minutes.pdf .
    29. FIFRA Science Advisory Panel (SAP). 2005b. ``Final report on
Preliminary N-Methyl Carbamate Cumulative Risk Assessment.'' Final
Report from the FIFRA Scientific Advisory Panel Meeting of July 29-30,
1998 (Report dated September 2, 1998). Available at: http://
www.epa.gov/scipoly/sap/2005/august/minutes.pdf.
    30. FIFRA Science Advisory Panel (SAP). 2008. ``Final report on the
Agency's Proposed Action under FIFRA 6(b) Notice of Intent to Cancel
Carbofuran.'' Report from the FIFRA Scientific Advisory Panel Meeting
of February , 5-8 2008 (Report dated September 2, 1998). Available at:
http://www.epa.gov/scipoly/sap/meetings/2008/february/
carbofuransapfinal.pdf.
    31. Final report on cholinesterase inhibition study of carbofuran:
PND17 rats. MRID 47167801 (ORD study). EPA-HQ-OPP-2007-1088-0064.
    32. FMC Letter Requesting Proposed Label Amendments and Voluntary
Cancellations. Dated May 9, 2008. EPA-HQ-OPP-2005-0162-0496 and -0497.
Email Communication from John Cummings to Steven Bradbury, dated June
10, 2008. EPA-HQ-OPP-2005-0162-0499.
    33. Hunter, D.L., Marshall, R.S., and Padilla, S. (1997). Automated
instrument analysis of cholinesterase activity in tissues from
carbamate-treated animals: A cautionary note. Toxicology Mechanisms and
Methods, 7:43-53.
    34. Interim Reregistration Eligibility Decision for Carbofuran. D.
Edwards. 2006. Regulations.gov document number: EPA-HQ-OPP-2005-0162-
0304.
    35. IPCS World Health Organization. 2005. Chemical Specific
Adjustment factors for Interspecies Differences and Human Variability:
Guidance Document for use of Data in Dose/Concentration-Response
Assessment.
    36. Issue Paper for the FIFRA SAP Meeting on Carbofuran: Human
Health Risk Assessment Reregistration Eligibility Science Chapter for
Carbofuran, Environmental Fate and Effects Chapter. March 2006. EPA-HQ-
OPP-2007-1088-0031.
    37. Johnson, C.D. and Russell, R.L. (1975) A rapid, simple
radiometric assay for cholinesterase, suitable for multiple
determinations. Analytical Biochemistry. 64:229-238.
    38. McDaniel K.L. and Moser V.C. (2004) Differential profiles of
cholinesterase inhibition and neurobehavioral effects in rats exposed
to fenamiphos or profenofos. Neurotoxicology and Teratology. 26:407-
415.
    39. McDaniel K.L., Padilla S., Marshall R.S., Phillips P.M.,
Podhorniak L., Qian Y., Moser V.C. (2007) Comparison of acute
neurobehavioral and cholinesterase inhibitory effects of N-methyl
carbamates in rats. Toxicology Sciences. 98, 552-560.
    40. Moser V.C. (1995) Comparisons of the acute effects of
cholinesterase inhibitors using a neurobehavioral

screening battery in rats. Neurotoxical and Teratology 17: 617-625.
    41. National Assessment of the Relative Vulnerability of Community
Water Supply Reservoirs in Carbofuran Use Areas. Performed by
Waterborne Environmental Inc., Leesburg, VA and Engel Consulting, West
Lafayette, IN. Submitted by FMC Corporation, Philadelphia, PA. WEI
Report No. 528.01-B, FMC Report No. PC-0387. MRID 47272301. EPA-HQ-OPP-
2007-1088-0024.
    42. National Resources Inventory 1992, cited in USGS 2002,
``Herbicide Concentrations in the Mississippi River Basin--the
importance of chloracetanilide degradates.'' R.A. Rebich, R.H. Coupe,
E.M.Thurman.
    43. Nostrandt, A.C., Duncan, J.A., and Padilla, S. (1993). A
modified spectrophotometric method appropriate for measuring
cholinesterase activity in tissues from carbaryl-treated animals.
Fundamentals of Applied Toxicology. 21:196-203.
    44. Padilla S., Marshall R.S., Hunter D.L., and Lowit A. 2007. Time
course of cholinesterase inhibition in adult rats treated acutely with
carbaryl, carbofuran, formetanate, methomyl, methiocarb, oxamyl, or
propoxur. Toxicology and Applied Pharmacology, 219; 202-209.
    45. PND17 BMDs and BMDLs and recovery half-lives for the effects of
carbofuran on brain and blood AChE (PND17--DR.pdf). EPA-HQ-OPP-2007-
1088-0047.
    46. Report on cholinesterase sensitivity study of carbofuran: Adult
and PND11 MRID 47289001 (ORD study). EPA-HQ-OPP-2007-1088-0065.
    47. Revised Drinking Water Assessment in Support of the
Reregistration of Carbofuran (PC Code 090601) (R. David Jones, 9/5/07
D3424057). EPA-HQ-OPP-2005-0162-0485.
    48. Revised HED Product Chemistry and Residue Chemistry Chapter of
the RED (D. Drew, 1/13/05, D306796). EPA-HQ-OPP-2005-0162-0028.
    49. Screening Level analysis of the small business impacts of
revoking carbofuran tolerances. (Wyatt, T.J. July 2008) 28 pgs.
    50. Setzer W. 2008 Carbofuran: Updated Statistical Analysis of the
FQPA Factor Based on the BMD50 ratio of Adult/Pup RBC Data.
7 pgs.
    51. Setzer W. October 23, 2007. Dose-time response modeling of rat
RBC AChE activity: Carbofuran gavage dosing. 47 pgs. EPA-HQ-OPP-2007-
1088-0029.
    52. Setzer W. October 25, 2007. PND17 BMDs and BMDLs and recovery
half-lives for the effect of Carbofuran on brain and blood AChE. 12
pgs. EPA-HQ-OPP-2007-1088-0047.
    53. Setzer W. October 5, 2007. Dose-time response modeling of rat
brain AChE activity: Carbofuran gavage dosing. 64 pgs. EPA-HQ-OPP-2007-
1088-0053.
    54. Summary Evaluation of Recently Submitted FMC Water Exposure
Studies. (PC Code 090601) (R. David Jones, 12/26/07 D347901), 12 pgs.
EPA-HQ-OPP-2007-1088-0016.
    55. USDA NRCS. Conservation Buffer to Reduce Pesticide Losses.
Natural Resources Conservation Service, Fort Worth, TX, 21 pp.
    56. USEPA (2000) ``Assigning Values to Nondetected/Nonquantified
Pesticide Residues in Human Health Dietary Exposure Assessments.''
March 23, 2000. Available at: http://www.epa.gov/pesticides/trac/
science/trac3b012.pdf.
    57. USEPA. (2000b). ``Benchmark Dose Technical Guidance Document.''
Draft report. Risk Assessment Forum, Office of Research and
Development, U.S. Environmental Protection Agency. Washington, DC. EPA/
630/R-00/001.
    58. USEPA. (2000) ``Choosing a Percentile of Acute Dietary Exposure
as a Threshold of Regulatory Concern.'' March 16, 2000. Available at:
http://www.epa.gov/pesticides/trac/science/trac2b054.pdf .
    59. USEPA. (2001). Memorandum from Marcia Mulkey to Lois Rossi.
``Implementation of the Determinations of a Common Mechanism of
Toxicity for N-Methyl Carbamate Pesticides and for Certain
Chloroacetanilide Pesticides.'' July 12, 2001. Available at: http://
www.epa.gov/oppfead1/cb/csb_page/updates/carbamate.pdf.
    60. USEPA. (2002). ``Office of Pesticide Programs' Policy on the
Determination of the Appropriate FQPA Safety Factor(s) For Use in
Tolerance Assessment.'' Available at: http://www.epa.gov/oppfead1/trac/
science/determ.pdf.
    61. USEPA. (2000). ``The Use of Data on Cholinesterase Inhibition
for Risk Assessments of Organophosphorous and Carbamate Pesticides.''
August 18, 2000. Available at: http://www.epa.gov/pesticides/trac/
science/cholin.pdf.
    62. USEPA. (2005). ``Preliminary N-Methyl Carbamate Cumulative Risk
Assessment.'' Available at: http://www.epa.gov/oscpmont/sap/2005/
index.htm#august.
    63. USEPA (2007). ``Revised N-Methyl Carbamate Cumulative Risk
Assessment U.S. Environmental Protection Agency, Office of Pesticide
Programs,'' September 24, 2007. Available at: http://www.epa.gov/
oppsrrd1/REDs/nmc_revised_cra.pdf.
    64. WARF, 1978. Rao, G.N.; Davis, G.J.; Giesler, P.; et al. (1978)
Teratogenicity of Carbofuran in Rats: ACT 184.33. (Unpublished study
received Dec 5, 1978 under 275-2712; prepared by WARF Institute, Inc.,
submitted by FMC Corp., Philadelphia, Pa.; CDL:236593-A).
    65. Watershed Regressions for Pesticides (WARP) Model Estimates for
Carbofuran in Illinois Watershed. Performed by Waterborne
Environmental, Inc., Leesburg, VA. WEI 362.07. Submitted by FMC
Corporation, Philadelphia, PA. Report No. P-3786. MRID 46688915. EPA-
HQ-OPP-2007-1088-0021.
    66. Williams, C.H. and Casterline, J.L., Jr. (1969). A comparison
of two methods for measurement of erythrocyte cholinesterase inhibition
after carbamate administration to rats. Food and Cosmetics Toxicology.
7:149-151.
    67. Winteringham, F.P.W. and Fowler, K.S. (1966) Substrate and
dilution effects on the inhibition of acetylcholinesterase by
carbamates. Biochemical Journal. 101:127-134.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 23, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as
follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

    2. Section 180.254 is amended by revising the table in paragraph
(a) and the table in paragraph (c), and by removing paragraph (d) to
read as follows.

Sec.  180.254  Carbofuran; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
Sunflower, seed (of which no more than 0.2 ppm          1.0     10/31/10
 is carbamate)
------------------------------------------------------------------------

* * * * *
    (c) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
Artichoke, globe (of which no more than 0.2             0.4     10/31/10
 ppm is carbamate)
------------------------------------------------------------------------

[FR Doc. E8-17660 Filed 7-29-08; 1:15 pm]

BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Notices]
[Pages 88322-88323]
[FR Doc No: 2016-29360]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2016-0136]

Pipeline Safety: Meeting of the Gas Pipeline Safety Advisory
Committee

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice; Advisory Committee meeting reschedule.

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SUMMARY: This notice announces that the public meeting of the Technical
Pipeline Safety Standards Committee, also known as the Gas Pipeline
Advisory Committee (GPAC), scheduled for December 7-8, 2016, has been
rescheduled for January 11-12, 2017. Notice of the original meeting
appeared in the Federal Register on November 22, 2016, (81 FR 83795).

DATES: The postponed meeting was scheduled for 8:30 a.m. to 5:00 p.m.
EST on both December 7, 2016, and December 8, 2016. The rescheduled
meeting will take place from 8:30 a.m. to 5:00 p.m. on both January 11,
2017, and January 12, 2017.
    The meetings will not be web cast; however, presentations will be
available on the meeting Web site and posted on the E-Gov Web site:
http://www.regulations.gov under docket number PHMSA-2016-0136 within
30 days following the meeting.

ADDRESSES: The meeting will be held at the Hilton Arlington, 950 North
Stafford Street, Arlington, VA, 22203. Additional information regarding
hotel and meeting registration and the agenda will be published on the
following pipeline advisory committee meeting and registration page:
https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=121.

Public Participation

    This meeting will be open to the public. Members of the public who
wish to attend in person are asked to register at: https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=121 no later than January
4, 2017, in order to facilitate entry and guarantee seating. Members of
the public who attend in person will also be provided opportunities to
make statements during the meeting.
    Written comments: Persons who wish to submit written comments on
the meeting may be submitted to the docket in the following ways:
    E-Gov Web site: http://www.regulations.gov. This site allows the
public to enter comments on any Federal Register notice issued by any
agency.
    Fax: 1-202-493-2251.
    Mail: Docket Management Facility; U.S. Department of Transportation
(DOT), 1200 New Jersey Avenue SE., West Building, Room W12-140,
Washington, DC 20590-0001.
    Hand Delivery: Room W12-140 on the ground level of the DOT West
Building, 1200 New Jersey Avenue SE., Washington, DC, between 9:00 a.m.
and 5:00 p.m., Monday through Friday, except on Federal holidays.
    Instructions: Identify the docket number PHMSA-2016-0136 at the
beginning of your comments. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Anyone can search the electronic form of
all comments received into any of our dockets by the name of the
individual submitting the comment (or signing the comment, if submitted
on behalf of an association, business, labor union, etc.). Therefore,
consider reviewing DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000, (65 FR 19477) or view the Privacy
Notice at http://www.regulations.gov before submitting any such
comments.
    Docket: For access to the docket or to read background documents or
comments, go to http://www.regulations.gov at any time or to Room W12-
140 on the ground level of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC, between 9:00 a.m. and 5:00 p.m., Monday
through Friday, except Federal holidays.
    If you wish to receive confirmation of receipt of your written
comments, please include a self-addressed, stamped postcard with the
following statement: ``Comments on PHMSA-2016- 0136.'' The Docket Clerk
will date stamp the postcard prior to returning it to you via the U.S.
mail.

Privacy Act Statement

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL- 14 FDMS), which can be reviewed at
www.dot.gov/privacy.
    Services for Individuals with Disabilities: The public meeting will
be physically accessible to people with disabilities. Individuals
requiring accommodations, such as sign language interpretation or other
ancillary aids, are asked to notify Cheryl Whetsel at
<EMAIL_ADDRESS>by December 30, 2016.

FOR FURTHER INFORMATION CONTACT: For information about the meeting,
contact Cheryl Whetsel by phone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Meeting Details and Agenda

    The GPAC will be discussing the proposed rule, ``Safety of Gas
Transmission and Gathering Pipelines'' published in the Federal
Register on April 8, 2016, (81 FR 20722), and the associated regulatory
analysis. PHMSA is proposing changes to part 192 that include:
     Requiring periodic assessments of pipelines in locations
where persons are expected to be at risk that are not already covered
under the integrity management program requirements;
     Modifying the repair criteria, both inside and outside of
high consequence areas;
     Requiring inspections of pipelines in areas affected by
extreme weather, man-made and natural disasters, and other similar
events;
     Providing additional specificity for in-line inspection,
including explicit requirements to account for uncertainty of reported
inspection data when evaluating in-line inspection data to identify
anomalies;
     Expanding integrity assessment methods to explicitly
address guided wave ultrasonic inspection and excavation with direct
in-situ examination;
     Providing clearer functional requirements for conducting
risk assessment for integrity management, including addressing seismic
risk;
     Expanding the mandatory data collection and integration
requirements for integrity management, including data validation and
seismicity;
     Adding requirements to address Management of Change;
     Repealing the use of API 80 for gathering lines;
     Applying Type B requirements to newly regulated Type A
gathering lines

in Class 1 locations to > 8-inch along with emergency requirements (GAO
Recommendation 14-667);
     Extending the reporting requirements to all gathering
lines;
     Expanding requirements for corrosion protection to specify
additional post-construction quality checks and periodic operational
and maintenance checks to address coating integrity, cathodic
protection, and gas quality monitoring;
     Requiring operators to report MAOP Exceedance;
     Requiring safety features on in-line inspection tool
launchers and receivers;
     Adding certain types of roadways to definition of
``identified sites'' (NTSB P-14-1); and
     Addressing grandfathered pipe and pipe with inadequate
records.
    The agenda, once finalized, will be published on the meeting page.

II. Committee Background

    The GPAC is a statutorily mandated advisory committee that advises
PHMSA on proposed gas pipeline safety standards and risk assessments
for transporting gas and for gas pipeline facilities. The committee is
established in accordance with the Federal Advisory Committee Act (5
U.S.C. App. 2, as amended) and 49 U.S.C. 60115. The committee consists
of 15 members--with membership evenly divided among the federal and
state governments, the regulated industry, and the general public. The
committees advise PHMSA on the technical feasibility, reasonableness,
cost-effectiveness, and practicability of each proposed pipeline safety
standard.

    Issued in Washington, DC on December 2, 2016, under authority
delegated in 49 CFR 1.97.
Alan K. Mayberry,
Acting Associate Administrator for Pipeline Safety.
[FR Doc. 2016-29360 Filed 12-6-16; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)]
[Notices]
[Page 1350]
[FR Doc No: 2018-00327]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-45-000]

Great River Energy; Notice of Institution of Section 206
Proceeding

    On January 5, 2018, the Commission issued an order in Docket No.
EL18-45-000, pursuant to section 206 of the Federal Power Act, 16
U.S.C. 824e (2012), instituting an investigation into whether Great
River Energy's cost-based revenue requirements for providing reactive
power from certain of its generating units located in the Midcontinent
Independent System Operator, Inc. region may be unjust and
unreasonable. Great River Energy, 162 FERC 61,006 (2018).
    Any interested person desiring to be heard in Docket No. EL18-45-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426, in accordance with Rule 214 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21
days of the date of issuance of the order.

    Dated: January 5, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-00327 Filed 1-10-18; 8:45 am]
BILLING CODE 6717-01-P