the results of bringing 1, 5, 20, 50, 100, 200 or 500 infected cattle into the US.  ]
4.3.1 Spontaneous
For this scenario, the model predicts an average of 27 infected animals over a 20-year
period (95 percentile value of 37).  It is predicted that only 2.6 animals, on average, would reach
th
the advanced stages of the disease (95 percentile of six).  Virtually all of the animals that
th
become infected develop the disease spontaneously, although maternal transmission and
tranmission from contaminated protein both make a small contribution.  A mean of 77 cattle oral
ID s are predicted to reach humans (95 percentile value of 220).
50
th
These results suggest that if this hypothesis is true the disease is essentially endemic, with
one-to-two cases occurring each year.  Current agricultural practices and regulations (the feed
ban) effectively check the spread of disease to other cattle but the disease cannot be eliminated
because it of its sporadic occurrence.  The very low number of animals developing clinical signs
would make detection through any method of surveillance very difficult.
4.3.2 Imports
Figure 4-3 illustrates the relationship between the number of infected cattle imported and
the mean number of new cases (i.e.,, the number of cases in addition to the imported animals)
during the 20 year period following the arrival in the U.S. of these imports.  Even with the
introduction of 100 BSE-infected cattle, there are fewer than 100 new cases of BSE in the
subsequent 20 years.
Figure 4-4 illustrates the relationship between the number of infected cattle imported and
human exposure to BSE infectivity (mean number of cattle oral ID s potentially available for
50
human consumption) during the 20 year period following the arrival in the U.S. of these imports.
The contribution of the different exposure routes is roughly the same as in the base case.  The
mean number of cattle oral ID s potentially available for human consumption over 20 years is
50
estimated to be approximately 2,000 following the introduction of 500 infected animals.  These
ID s result from the consumption of both the introduced cases and the new cases that follow.
50

Section 4
-
91 -
Finally, Figure 4-6. illustrates the relationship between the number of infected cattle
imported and the probability that BSE will still be present in the U.S. 20 years following these
imports.  The results indicate that after 20 years, BSE is eliminated with 90% probability even
following the introduction of 500 infected cattle.  The probability of cases remaining 20 years
after the introduction of one sick animal is zero.  The tendency for BSE to be eliminated is also
implied by the predicted number of new infected animals following the import of infected
animals.  Unless the number of new cases exceeds the number of challenge cases (i.e., unless
each case gives rise to more than one case on average), the disease will tend to die out.  The time
it takes to die out depends on the number of infected animals introduced initially.
4.3.3 Scrapie
This simulation evaluates the impact of assuming that scrapie contributes one cattle oral
ID
50
to feed consumed by cattle each month.  The simulation predicts that this contamination
results in an average of 38 infected cattle over a period of 20 years (95
th
percentile estimate of
63).  The simulation also predicts that an average of about six animals would develop clinical
symptoms during that period (95 percentile of 13).  Current surveillance would be unlikely to
th
detect this number of clinical cases.  On average, approximately 90 cattle oral ID s are predicted
50
to be available for potential human exposure during the 20 y ear period (95 percentile estimate
th
of 260).
Because scrapie is assumed to contaminate cattle feed continually, the disease would
essentially be endemic.  Note that the simulation predicts that most new cases of BSE would arise
directly from exposure to scrapie infectivity, although a small number would result from exposure
to contaminated ruminant protein that slips through the feed ban.  Maternal transmission makes a
small contribution to the total.
We expect that the predictions made here are likely to overstate the true contribution of
scrapie to BSE, as explained in Section 3.3.3.  In brief, it is likely that the true species barrier is
greater than the value of 1,000 used (it has proven impossible to transmit North American scrapie
orally to cattle), and the prevalence of scrapie in the U.S. is probably less than the UK prevalence
rates used in the calculation.  Section 3.3 of Appendices 3A and 3B detail the simulation results.

Section 4
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92 -
4.4 Alternative Scenarios
This section details the results of several simulations designed to investigate further
factors influencing spread of BSE infectivity.  The first scenario described models the small BSE
outbreak in Switzerland as check on the plausibility of our model (section 4.4.1).  Next we
examine the spontaneous hypothesis by looking at how spontaneous disease might have spread in
the years before the FDA feed ban (section 4.4.2).  Section 4.4.3 examines how importation of
cattle from the UK during the 1980s may have affected the U.S.  The last two sections evaluate
specific risk management strategies, including a specified risk material (SRM) ban identical to
that imposed in the UK (Section 4.4.4), and a prohibition on the rendering of animals that die on
the farm (Section 4.4.5).
4.4.1 Switzerland
As discussed in Section 3.4.1, our model is not amenable to formal validation because
there are no known controlled experiments in which the introduction and consequences of BSE
introduction to a country has mean monitored and measured.  However, as a test of the model’s
plausibility, we model the small BSE outbreak reported in Switzerland following the introduction
of BSE infectivity from the UK.  Our simulation took into account risk management actions taken
by the Swiss during the ensuing period (e.g., the introduction of a feed ban regulation).
The model predicts both the total number of infected animals in Switzerland and those
that develop clinical disease.  Only the latter can be detected using the standard surveillance
methods in use early in the outbreak.  Current surveillance practices can detect disease in animals
several months before development of clinical signs.  We also describe the predicted the time
course of the BSE outbreak.
Our simulation of Switzerland predicts an average of approximately 480 infected
animals, 170 of which develop clinical signs of the disease.  It is impossible to know the true
number of infected animals in Switzerland (because some may not have been identified), but the
Swiss did report the identification of 324 animals with clinical signs between 1990 (when the first
case was identified) and 2000.  Our simulation follows a time course similar to that observed in
Switzerland where risk management measures, including feed bans, have reduced the number of
clinical cases found and the outbreak appears to be abating. Complete simulation results appear
in Section 4.1 of Appendices 3A and 3B.

Section 4
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93 -
Our model’s modest underprediction of clinical cases could be due to incorrect
specification of the number of infected animals imported or amount of contaminated feed
introduced, among other factors.  At the same time, the similarity of our predictions and the
observations from Switzerland provide some confidence that the model’s structure and approach
are reasonable.  It is important to note that this is not a true validation and, in fact, the model’s
predictions could be close to reported observations for the wrong reasons.  However, given the
absence of data suitable for validating the model, the results of the Switzerland scenario are
encouraging.
4.4.2
Spontaneous With no Feed Ban
To further investigate the spontaneous hypothesis, we modeled a scenario in which
spontaneous disease occurs using the rates described in Section 3.3.1, but no feed ban is present
to mitigate the recycling of infectivity in ruminant feed.  The scenario, described in Section 3.4.2
was run for 20 years.
The absence of a feed ban allows BSE infectivity to rapidly spread throughout the cattle
population.  The mean projection for this scenario suggests 42,000 animals infected over the 20
year period (95 percentile of 190,000).  The average number of clinical animals predicted is
th
1,500 (95 percentile of 6,600).
th
It should be noted that the simulation often predicts that the BSE prevalence rapidly
increases towards the end of the twenty year period (see Section 4.2 in Appendices 3A and 3B for
complete results).  This tendency suggests that if a longer time period were simulated, the model
would predict a much greater burden of disease.  Hence, while some simulation runs predict
prevalence rates that are low enough to be compatible with the fact that BSE has not been
detected in the U.S., the results suggests that even in these cases, the prevalence would climb
much higher if a longer period were simulated.  That is, in the absence of a feed ban, the
prevalence would most likely reach a detectable level in any case in just over 20 years.  The fact
that BSE was not detected in the U.S. prior to the implementation of the feed ban therefore
suggests that either spontaneous disease either does not occur, or that its incidence is less than we
have assumed.  Alternately, the imposition of the feed ban may have stopped an epidemic before

Section 4
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94 -
it could reach detectable levels.  In that case, the base case results suggest that the feed ban will
eliminate the disease shortly.
4.4.3
Cattle Imported from the UK in the 1980s
This scenario investigates the likelihood that BSE infectivity could have been introduced
into the U.S. by the 173 cattle imported from the UK during the 1980s that may have
contaminated either human food or animal feed (see Section 3.4.3).  We also determine the
amount of infectivity that may have been introduced.  Using these findings, we characterize the
likelihood that BSE could have been introduced into the U.S. and remained undetected.
As discussed in Section 3.4.3, some of the cattle imported into the U.S. from the UK
between 1980 and 1989 may have been infected with BSE without showing clinical signs of the
disease.  As a result, diseased animals may have contaminated animal feed in this country.  Figure
4-6 illustrates the cumulative distribution for the amount of infectivity (cattle oral ID s) that may
50
have been in feed consumed by cattle in the U.S. (see methodology in Section 3.4.3 and Section
1.1 of Appendix 2).  The distribution indicates it is likely (probability of 82%) that U.S. cattle
were exposed to no infectivity from cattle imported from the UK.  The probability that cattle were
exposed to no more than 0.1 ID s is 84%, the probability that they were exposed to no more than
50
one ID
50
is 86%, the probability that they were exposed to no more than five ID s is 91%, the
50
probability that they were exposed to no more than ten ID s is 93%, and the probability that they
50
were exposed to no more than 50 ID s is 96%.
50
To characterize the impact of introducing infectivity into the U.S. during the 1980s, we
have simulated the introduction of 0.1, 1.0, 5.0, 10.0, and 50.0 cattle oral ID s into cattle feed in
50
1980, and followed the evolution of the U.S. cattle population through 2010.  The results of these
simulations (see Section 4.3 in Appendices 3A and 3B) can be used to quantify the likely number
of clinical BSE cases that would have occurred and hence to assess the plausibility of these
scenarios in light of the fact that BSE has not been detected in the U.S.  In particular,
introductions that result in too large a number of clinical cases to be compatible with the fact that
BSE has not been detected in the U.S. are not plausible.
Note that the distributions for the output quantities are highly skewed, indicating that
under most circumstances the infectivity did not spread widely but that occasionally, there was a

Section 4
-
95 -
combination of events leading to significant numbers of infected cattle.  For example, when 0.1
cattle oral ID
50
is introduced into feed, more than 950 of the 1,000 simulation runs for this
scenario produced no new cases of disease.  However, a few runs produced substantial numbers
of diseased animals.  Hence the mean number of infected animals (over all 1,000 simulations) is
45, and the mean number of animals with clinical signs is ten.  Introducing larger quantities of
infectivity also yields right-skewed results distributions.
The probability that BSE was introduced into the U.S. depends on two events – the
introduction of contaminated material from imported animals into domestic cattle feed
(probability of 18%), and the infection of exposed cattle and subsequent spread of BSE to other
animals without the creation of so many cases that it would have been likely to have been
discovered by surveillance.  Figure 4-7 illustrates for the year 2000 (year 20 of the simulation) the
predicted number of clinical (i.e., detectable) cattle following introduction of 0.1, 1.0, 5.0, 10,0,
or 50.0 cattle oral ID s from the imported UK animals.  Also plotted is the USDA’s estimate of
50
the number of clinical cases surveillance would have detected in the year 2000 with 95%
probability (Victoria Bridges, personal communication).  For example, the curve in Figure 4-7
corresponding to the introduction of 10.0 ID s indicates that there is an 82% chance that this
50
introduction caused no new BSE cases in the U.S. , and that it could have resulted in a maximum
4
of approximately 1,100 clinical cases in the year 2000.  However, all values exceeding the
detection limit of 470 clinical cases in the year 2000 (i.e., above the horizontal “detection limit”
line) are incompatible with the fact that no BSE has been detected in the U.S.  For the
introduction of 10.0 ID s, there is a 6% chance that the number of clinical cases in 2000 exceed
50
this limit (i.e., a 94% chance that this number was below the detection limit).  Hence, even if
cattle in the U.S. did consume 10.0 ID s in 1980, there is only a 12% chance (94% minus 82%)
50
that it resulted in BSE cases that have not been found.  Corresponding probabilities can be
computed for the other ID
50
introductions considered.
Taken together, Figures 4-6 and 4-7 are useful for evaluating the likelihood that BSE
cattle imports from the UK during the 1980s introduced BSE into the U.S. but the disease has not
spread to enough animals to be detected.  First, there is only an 18% chance that cattle in the U.S.
4
Figure 4-7 illustrates the number of clinical cases in the year 2000, not the total number of BSE cases
caused by the import of BSE-infected cattle from the UK.  However, the scenario simulated assumes that
action to mitigate the spread of BSE in the U.S. occurs only after implementation of the feed ban in 1997.
Hence, as suggested by the figures in Section 4.3 of Appendix 3B, the number of clinical animals peaks

Section 4
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were exposed to any infectivity (see Figure 4-6).  Second, if cattle were exposed to infectivity,
there is only a limited probability that both 1) any cattle in the U.S. became infected, and 2) the
number of clinical cases (in the year 2000) was less than the number that would have been likely
to have been detected (see Figure 4-7).
Finally, the Figures in Section 4.3 of Appendix 3B illustrate how the disease spreads and
contracts if it is introduced into the U.S. The figures suggest that the number of animals with
detectable disease peaks in year 20 and declines thereafter.  This prediction indicates that even if
infectivity has been introduced from UK cattle imported before 1989, the disease rate has peaked
and BSE will eventually be eradicated.  The decline in the predicted disease prevalence in the
U.S. is due primarily to the introduction of the FDA feed ban in 1997.
4.4.4
Specified Risk Material Ban
A risk management step that has been taken in many countries with BSE is the
prohibition of certain tissues being used in either animal feed or human food.  These specified
risk material (SRM) bans focus on tissues carrying the greatest level of BSE infectivity.  To
evaluate the effects of this approach in the U.S. if BSE were to be introduced, we altered the base
case scenario as described in section 3.4.4 to mimic the UK SRM ban.
The SRM ban has a dramatic effect on potential human exposure or the spread of BSE to
cattle.  Following the introduction of 10 infected cattle, as in the base case, the mean number of
new BSE cases is reduced by 82% (from 2.9 to 0.51) and the mean number of cattle oral ID s
50
potentially available for human exposure decreases by 95% (from 35 to 1.7).  Results for this
scenario appear in Section 4.4 of Appendices 3A and 3B.
4.4.5
Prohibition on Rendering Animals that Die on the Farm
The results for the base case simulation (section 4.2 and Section 1 in Appendices 3A and
3B) make clear that if the BSE is introduced into the U.S., the greatest potential source of
infectivity in the feed system is animals that die on the farm and are rendered.  The simulations in
this report assume an animal lives for between two and six months following the development of
around the year 2000.  As a result, if there are zero clinical animals in the year 2000, it is almost certain that
few if any animals were infected in the U.S.

Section 4
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97 -
clinical signs.  If the animal is not sent to slaughter, it dies on the farm.  Rendering an animal that
has reached the clinical stage of disease introduces the maximum amount of infectivity into
rendering and potentially into feed.  Hence, a single breach of the feed ban can introduce expose
cattle to a substantial amount of BSE infectivity.  This scenario evaluates a risk management
strategy that prohibits the rendering of animals that die on the farm.
The simulation results indicate that this risk management strategy would have a
substantial effect on the spread of BSE to other cattle following introduction of ten infected cattle.
Compared to the base case, the mean number of new cases decreases by 77% (from 2.9 to 0.68).
Although this approach targets the spread of BSE to other animals, it still has an effect on
potential human exposure to BSE infectivity, decreasing this quantity by 20% because it
decreases the number of new BSE cases.  Complete results appear in Section 4.5 of Appendices
3A and 3B.
4.5 Summary
This report is intended to address the potential for BSE to become a major animal health
or public health threat in the U.S.  Based on the simulation model and assumptions developed for
this analysis, inferences can be drawn about the robustness of regulations and practices in the
U.S., and data or research can be identified that would increase confidence in predictions.  In
addition, it is possible to characterize the potential impact that various sources of BSE may have
had in the U.S., including cattle imported from the UK in the 1980s.  Finally, the simulation can
be used to characterize the effectiveness of additional risk management strategies.
We recognize that the identification of a single case of BSE in the U.S. would have
important ramifications for public opinion, trade, and other areas.  Yet this analysis demonstrates
that even if BSE were somehow to arise in the U.S., few additional animals would be infected,
little infectivity would be available for potential human exposure, and the disease would be
eradicated.  In short, the U.S. appears very resistant to a BSE challenge, primarily because of the
FDA feed ban, which greatly reduces the chance that a sick animal will infect other animals.
However, the effectiveness of the feed ban is somewhat uncertain because compliance rates are
not precisely known.

Section 4
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Potential sources of human exposure to BSE infectivity can be divided into two
categories: specific high-risk tissues and contamination of low-risk tissues.  Although not widely
popular in the U.S., both brain and spinal cord are consumed by some members of the population.
If BSE were present in the U.S., these tissues would be an obvious source of exposure.  Our
analysis indicates that the most important means by which low risk tissue can become
contaminated is the use of advanced meat recovery (AMR) technology, which can leave spinal
cord or dorsal root ganglia (DRG) in the recovered meat.  Our analysis further indicates mis-
splitting of the spinal column and the resulting incomplete removal of the spinal cord is largely
responsible for contamination of AMR meat.  In addition, we assume that even in the absence of
mis-splitting, some amount of DRG is extracted whenever vertabrae are processed by AMR.
Contamination due to aerosolization of the spinal cord during splitting contributes substantially
less contamination even though it occurs every time an infected animal is processed.
Despite the potential for the consumption of high risk-tissues and the contamination of
low-risk tissues, our results indicate that only small amounts of infectivity are available for
human consumption.  The import of one infected animal yields in an average of 2.7 cattle oral
ID s for potential human exposure over a 20 year period, while the import of ten infected cattle
50
results in an average of 35 cattle oral ID s this period.  These results can be put into context by
50
comparing them to potential exposure in the UK where it is estimated almost one million cattle
were infected over a 15 to 20 year period.  If the UK population was potentially exposed to only
one cattle oral ID
50
from each of these animals, potential human exposure in the UK would dwarf
our projections for the U.S.  At this time, just over 100 cases of variant Creutzfeldt-Jakob disease
(the human TSE linked to BSE) have been identified in the UK, although projections range from
a few hundred to tens of thousands of eventual cases.  If cattle oral ID s available for human
50
consumption is a good indicator of possible disease risk, it is unlikely the UK experience would
be duplicated in the U.S.
There are a number of model assumptions that cannot be verified with confidence, some
of which influence the conclusions drawn.  With regard to estimating the spread of BSE among
cattle, the most influential sources of uncertainty are related to compliance with the FDA feed
ban.  Within this category, the most important source of uncertainty is the misfeeding rate on
farms.  Misfeeding prohibited feed (containing ruminant protein) to cattle on farms that raise both
cattle and either pigs or chickens completely compromises the feed ban.  This practice is the
focus of efforts to understand how animals born after the implementation of feed bans in Europe

Section 4
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99 -
have become infected with BSE.  Uncertainty with respect to compliance rates can be reduced
with field work and data collection.  A second source of uncertainty associated with the feed ban
is the proportion of feed produced that is mislabeled (i.e., lacks the proper labels identifying it as
feed not to be administered to ruminants).
Improving estimates of compliance with the feed ban would also improve estimates of
potential human exposure to BSE-contaminated meat.  Other important sources of uncertainty
influencing estimates of human exposure include:  the number of ID s per clinical case of BSE,
50
and the proportion of clinical animals that would be correctly identified by ante mortem
inspectors.  While the first of these two factors may be amenable to research, it is not clear how
estimates for the second factor could be improved.
We have identified three important ways in which BSE could be introduced into the U.S:
1) cross-species transmission from a native TSE like sheep scrapie, 2) spontaneous development
of the disease in a native animals, or 3) the import of an infected animal or animal product from a
country with BSE.  The analysis suggests that either cross-species transmission of a TSE (scrapie)
or spontaneous disease, if they can occur, would lead to only a few cases of BSE each year and
would result in relatively little potential human exposure.  However, results from our evaluation
of the impact of spontaneous BSE on the U.S. prior to the 1997 FDA feed ban casts doubt on the
plausibility of this potential source of BSE. In particular, these results suggest there is a
substantial probability that the number of animals with clinical signs would be sufficiently high to
be inconsistent with the fact that surveillance has failed to detect BSE in the U.S. At the same
time, the simulation results indicate that there is a non-trivial probability that spontaneous BSE
would generate an insufficient number of animals to be detected by surveillance.
It is impossible to know if an infected animal was imported from the UK in the 1980s.
Our analysis suggests it is highly unlikely. First, the imported animals whose disposition is not
known came from farms where the disease was not found in any animal born the same year.
Second, the beef breeding animals imported had little exposure to potentially infected protein
supplements while in the UK.  Finally, many of the animals are known to have lived beyond the
average incubation period once they arrived in the US.  Nonetheless, there is some small
probability that at least one of these animals was infected and that infectivity from such an animal
contaminated feed consumed by cattle in the U.S.  Exposure to infectivity among U.S. cattle
could not have been substantial because in the years prior to the 1997 FDA feed ban, such

Section 4
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exposure would have eventually resulted in a substantial number of clinical cases, a prediction
that is inconsistent with the fact that BSE has not been identified in the U.S. to date.  There is
therefore a small chance that BSE could have been introduced into the U.S. and remained
undetected.  Even if BSE was introduced, actions by USDA and FDA have already arrested the
spread of the disease and have begun to reduce its prevalence.  If BSE is present in the U.S., these
actions will ultimately lead to the disease’s eradication.
Evaluation of potential risk management actions highlights an additional benefit of this
type of analysis.  The insights provided by the model demonstrated that steps very early in the
rendering and feed production process can avoid the need for other, more obvious, measures.
Specifically, removing most of the infectivity from rendered product can protect human and
animal health even if the feed ban is not 100% effective.  Prohibiting the rendering of dead
animals, which may have died of BSE and hence have high levels of infectivity, or disposing of
all specified risk materials both reduce potential new cases of BSE by more than 75%.  The
misfeeding rate, a key parameter identified in our sensitivity analysis, is not important if the
infectivity in prohibited MBM is greatly reduced or eliminated.  The SRM ban also reduces
substantially the amount of infectivity available for potential human exposure.  Of course, it must
be recognized that even in the absence of these measures, animal health risks and human
exposure are both small, with the import of ten infected cattle leading to an average of fewer than
three new cases of BSE and potential human exposure to 35 cattle oral ID s.
50
As we strive to learn from BSE and limit the extent of the disease, the model developed
for this analysis has many potential uses.  It is flexible and can be changed easily.  For example, if
appropriate data are available, its parameters can be modified so that other countries or regions
can be simulated.  Specific scenarios of interest can be evaluated, including risk management
actions under consideration.  The model can also be used to evaluate hypotheses about sources
and factors influencing the BSE’s spread.  We hope this model will find a place among the useful
tools for understanding and controlling BSE.

References
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101 -
References:
Agrimi, U., G. Ru, et al. (1999). “Epidemic of transmissible spongiform encephalopathy in sheep
and goats in Italy.” Lancet 353(9152): 560-1.
Airtime Internet Resources (2001). “Hypotheses for the origin and spread of BSE.”
http://sparc.airtime.co.uk/bse/hypoth.htm#15.
Alpers, M. (1970). “Kuru in New Guinea: its changing pattern and etiologic elucidation.”
American Journal of Tropical Medicine & Hygiene 19(1): 133-7.
Anderson, R. M., C. A. Donnelly, et al. (1996). “Transmission dynamics and epidemiology of
BSE in British cattle.” Nature 382(6594): 779-88.
Andreoletti, O., P. Berthon, et al. (2000). “Early accumulation of PrP(Sc) in gut-associated
lymphoid and nervous tissues of susceptible sheep from a Romanov flock with natural scrapie.”
Journal of General Virology. 81(12): 3115-26.
Anil, M. H., S. Love, et al. (1999). “Potential contamination of beef carcasses with brain tissue at
slaughter.” Veterinary Record 145(16): 460-2.
Anonymous (1996). “Surveillance for Creutzfeldt-Jakob disease--United States.” MMWR -
Morbidity & Mortality Weekly Report 45(31): 665-8.
Belt, P., I. Muileman, et al. (1995). “Identification of five allelic variants of sheep PrP gene and
their association with natural scrapie.” Journal of General Virology 76(509-517).
Biopharm (1997). “Assessment of the risk of bovine spongiform encephalopathy in
Pharmaceutical Products.” http://www.biopharm-mag.com/resources/pharma0198.htm.
Bolton, D. C., M. P. McKinley, et al. (1982). “Identification of a protein that purifies with the
scrapie prion.” Science 218(4579): 1309-11.


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	1 August 2007

SUBJECT:	Fluazinam Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Ginseng, Brassica Vegetables, Legume Vegetables, and Bushberries.

PC Code:	129098			Decision Number:  372193

DP Number:	340854

REVIEWER:	Michael A. Doherty, Ph.D., Chemist

Registration Action Branch 2

Health Effects Division (7509P)

THROUGH:	Christina Swartz, Branch Chief

William Cutchin, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

Richard A. Loranger, Ph.D., Branch Senior Scientist

Registration Action Branch 2

Health Effects Division (7509P)

TO:		Karlyn J. Bailey, Toxicologist

Registration Action Branch 2

Health Effects Division (7509P)

and

Shaja Brothers/Dan Rosenblatt, Team 05

Risk Integration, Minor Use, and Emergency Response Branch

Registration Division (7505P)

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model DEEM-FCID™, Version 2.03 which use food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were conducted as part of a human health aggregate risk assessment for the requested uses of fluazinam on ginseng, Brassica vegetables, legume vegetables, and bushberries.  An assessment of cancer risk is not necessary for this chemical.

Both the acute and chronic analyses are based on tolerance-level residues, assume 100% crop treated, and incorporate modeled estimated drinking water concentrations (EDWCs).  Therefore, the resulting exposure and risk estimates should be considered high-end and very conservative.  Actual exposures and risks from fluazinam will likely be lower than the values presented in these analyses.

The acute risk estimates are below HED’s level of concern for all population subgroups, including those of infants and children.  Generally, HED is concerned when risk estimates exceed 100% of the population-adjusted dose (PAD).  The acute risk estimate for the U.S. population, as a whole, is 1% of the acute PAD (aPAD).  For females 13-49 years of age, the risk estimate is 8% of their aPAD.  Risk estimates for all other population subgroups are less than 8% aPAD.  Likewise, chronic risk estimates are below HED’s level of concern for all population subgroups.  The risk estimate for the U.S. population is 9% of the chronic PAD (cPAD).  The highest risk estimate is for the “all infant” population subgroup at 16% cPAD.

These analyses indicate that there are no dietary exposure considerations that preclude establishing tolerances for fluazinam.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population-adjusted dose (PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21 Jun 2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (20 Aug 1999).

The most recent dietary risk assessment for fluazinam was conducted by W. Cutchin (22 Aug 2001, D276982).

II.	Residue Information

Fluazinam is currently registered in the U.S. for use on potato and peanut, each with a tolerance of 0.02 ppm [40 CFR 180.574].  In addition, there is a tolerance of 3.0 ppm for residues in/on wine grapes (no U.S. registration).  The residues of concern for risk assessment are fluazinam and its metabolite AMGT, combined.  Field trial data reflecting AMGT residues were not provided for brassica vegetables and legume vegetables; therefore, an upper-bound ratio of 0.35:1 (AMGT:fluazinam) was used to estimate the AMGT residue in these crops.  AMGT is not formed in root and tuber crops and this factor was not used for residues in/on potato and ginseng.  For bushberries, the mean ratio of the metabolite:parent residues (0.11:1) from field trials was used to estimate total residues of concern.   The residues used in the assessments are based on tolerance-level residues of fluazinam (Table 1) and should be considered high-end estimates.  The residue estimates shown in Table 1 were used for both acute and chronic analyses.  The assessment assumed 100% crop treated and used DEEM 7.76 default processing factors for processed commodities (e.g., dried potato).  A full listing of the residue inputs used in the analyses is included as Attachments 1 and 2.

Table 1.  Summary of New-Use Food Crop Residue Levels Used in the Acute and Chronic Dietary Exposure Analyses.

Crop/Crop Group	Recommended Tolerance Level, ppm	Residue Level for Dietary Exposure Assessment, ppma

Ginseng	4.5	4.5b

Brassica Vegetables (Group 5)	0.01	0.0135

Edible Podded Legumes (except peas; Group 6A)	0.1	0.135

Succulent Shelled Pea and Bean (Group 6B)	0.04	0.054

Dried Shelled Pea and Bean (Group 6C)	0.02	0.027

Bushberries (Group 13B)	7.0	7.8c

a Residue level = recommended tolerance × 1.35 (from grape metabolism data)

b AMGT is not a significant residue in root and tuber crops and no correction is necessary for risk assessment

c Residue level = recommended tolerance × 1.11 (from field trial data)

 Drinking Water Data

The drinking water residue used in the dietary risk assessment was provided by the Environmental Fate and Effects Division (EFED; J. Meléndez, D334948, 7 Feb 2007) and incorporated directly into this dietary assessment into the food categories “water, direct, all sources” and “water, indirect, all sources.”  The estimated drinking water concentration (EDWC) of 0.071 ppm is the estimated peak concentration from the FIRST model (for more information, see   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ ) and was used for the acute assessment.  The chronic assessment uses the EDWC based on total residues of fluazinam in surface water (Table 2).

Table 2.  Maximum Tier I Estimated Drinking Water Concentrations (EDWCs) for drinking water assessment based on ground application of fluazinam.

Drinking Water Source (Model Used) 	USE (Rate Modeled)	Maximum Estimated Drinking Water Concentration  (EDWC; ppb)

Groundwater

(SCI-GROW) Fluazinam and Total Residues of Fluazinam	Bushberries (3.90 lb a.i./A)	Acute and Chronic	0.187

Surface Water

(FIRST) Fluazinam	Bushberries (3.90 lb a.i./A)	Acute	71.0

	Bushberries (3.90 lb a.i./A)	Chronic	0.7

Surface Water

(FIRST) Total Residues of Fluazinam	Bushberries (3.90 lb a.i./A)	Acute 71.0

	Bushberries (3.90 lb a.i./A)	Chronic	17.7

IV.	DEEM-FCID™ Program and Consumption Information

Fluazinam acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID™,Version 2.03 which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

Adequate toxicological data have been submitted to permit assessment of fluazinam.  The data show that the primary target organ for fluazinam is the liver and that acute and chronic dietary assessments are appropriate.  The data also support reducing the FQPA factor to 1X.  Based on the available information, a dietary assessment of cancer risk is not necessary.  Detailed toxicological considerations can be found in the human health risk assessment for fluazinam (K. Bailey et al., D334949).  The fluazinam doses and endpoints for dietary exposure assessments are summarized in Table 3.

Table 3.  Toxicological Doses and Endpoints for Fluazinam for Use in Dietary Health Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/

FQPA Safety Factors	RfD, PAD, Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary (General population)	NOAEL= 50 mg/kg/day

	UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x	Acute RfD =0.5 mg/kg/day

aPAD

= 0.5mg/kg/day	Acute Neurotoxicity-Rats.

LOAEL = 1000 mg/kg/day based on decreased motor activity and soft stools on day of dosing.

Acute Dietary

(Females 13-49 years of age)	NOAEL (developmental) = 7 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x	Acute RfD =0.07 mg/kg/day

aPAD

= 0.07mg/kg/day	Developmental Toxicity- Rabbits.

Developmental LOAEL = 12  mg/kg/day based on increased incidence of total litter resorptions and possible increased incidence of fetal skeletal abnormalities.

Chronic Dietary (All Populations)	NOAEL= 1.1 mg/kg/day

	UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x	Chronic RfD =0.011 mg/kg/day

cPAD

= 0.011mg/kg/day	Carcinogenicity-Mice.

LOAEL = 10.7 mg/kg/day based on liver histopathology and increased liver weight.

Cancer (oral, dermal, inhalation)	Classification: “Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential”

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose. N/A = not applicable.

  TC \l3 "3.5.10	Classification of Carcinogenic Potential

VI.	Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 4 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.  Risk estimates for all population subgroups, for both the acute and the chronic analyses, are below HED’s level of concern.  Full listings of exposure and risk estimates are included in Attachments 3 (acute analysis) and 4 (chronic analysis).

Table 4.  Summary of Acute and Chronic Exposure and Risk Estimates for Fluazinam.

Population Subgroup	Acute Assessment (95th Percentile)	Chronic Assessment

	PAD, mg/day	Exposure Estimate, mg/day	% Pad	PAD, mg/day	Exposure Estimate, mg/day	% Pad

U.S. Population	0.5	0.006015	1	0.011	0.000953	9

All infants	0.5	0.015211	3	0.011	0.001799	16

Children 1-2 yrs	0.5	0.007019	1	0.011	0.001133	10

Children 3-5 yrs	0.5	0.006323	1	0.011	0.000996	9

Children 6-12 yrs	0.5	0.004439	1	0.011	0.000650	6

Youth 13-19 yrs	0.5	0.003344	1	0.011	0.000438	4

Adults 20-49 yrs	0.5	0.005903	1	0.011	0.000996	9

Adults 50+ yrs	0.5	0.006933	1	0.011	0.001123	10

Females 13-49 yrs	0.07	0.005809	8	0.011	0.001016	9

Assessments with the highest risk estimates are bolded

VII.	Characterization of Inputs/Outputs

Both the acute and chronic assessments are based on tolerance-level residues, with worst-case assumptions regarding levels of the metabolite AMGT.  In addition, it was assumed that all crops with registered or requested uses of fluazinam were treated (i.e., 100% crop treated).  These assumptions result in highly conservative, health-protective estimates of exposure and risk.

VIII.	Conclusions

The exposure estimates derived by the dietary exposure model are likely to be overestimates of actual exposures that may occur.  Even so, the aggregate (food + water) dietary risk estimates are below HED’s level of concern for all population subgroups for both the acute and chronic exposure scenarios.  There are no dietary exposure considerations that preclude registering the proposed uses and establishing tolerances at the levels recommended by HED.

IX.		List of Attachments

Attachment 1.  Residue inputs for the acute dietary exposure assessments of fluazinam.

Attachment 2.  Residue inputs for the chronic dietary exposure assessments of fluazinam.

Attachment 3.  Summary of acute dietary exposure and risk analysis for fluazinam.

Attachment 4.  Summary of chronic dietary exposure and risk analysis for fluazinam.

cc:	M. Doherty (HED/RAB2), W. Drew (HED/RAB2)

Attachment 1.  Residue inputs the acute dietary exposure assessments of fluazinam.

U.S. Environmental Protection Agency                                 Ver. 2.02

DEEM-FCID Acute analysis for FLUAZINAM

Residue file name: C:\Documents and Settings\mdoherty\My Documents\Chemistry Reviews\DEEM Runs\Fluazinam\129098a.R98

Analysis Date 07-17-2007             Residue file dated: 07-17-2007/10:27:53/8

Reference dose (aRfD) = 0.5 mg/kg bw/day

Comment: aPAD of 0.5 kg/day is for general pop.  Female 13-49 aPAD = 0.07 mg/day

------------------------------------------------------------------------ --------

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Food Name                         (ppm)       #1    #2

-------- ---- -------------------------------  ----------  ------ ------  -------

06030300 6C   Bean, black, seed                  0.027000   1.000  1.000

06020310 6B   Bean, broad, succulent             0.054000   1.000  1.000

06030320 6C   Bean, broad, seed                  0.027000   1.000  1.000

06020330 6B   Bean, cowpea, succulent            0.054000   1.000  1.000

06030340 6C   Bean, cowpea, seed                 0.027000   1.000  1.000

06030350 6C   Bean,  great northern, seed        0.027000   1.000  1.000

06030360 6C   Bean, kidney, seed                 0.027000   1.000  1.000

06020370 6B   Bean, lima, succulent              0.054000   1.000  1.000

06030380 6C   Bean, lima, seed                   0.027000   1.000  1.000

06030390 6C   Bean, mung, seed                   0.027000   1.000  1.000

06030400 6C   Bean, navy, seed                   0.027000   1.000  1.000

06030410 6C   Bean, pink, seed                   0.027000   1.000  1.000

06030420 6C   Bean, pinto, seed                  0.027000   1.000  1.000

06010430 6A   Bean, snap, succulent              0.135000   1.000  1.000

06010431 6A   Bean, snap, succulent-babyfood     0.135000   1.000  1.000

13020570 13B  Blueberry                          7.800000   1.000  1.000

13020571 13B  Blueberry-babyfood                 7.800000   1.000  1.000

05010610 5A   Broccoli                           0.013500   1.000  1.000

05010611 5A   Broccoli-babyfood                  0.013500   1.000  1.000

05010620 5A   Broccoli, Chinese                  0.013500   1.000  1.000

05020630 5B   Broccoli raab                      0.013500   1.000  1.000

05010640 5A   Brussels sprouts                   0.013500   1.000  1.000

05010690 5A   Cabbage                            0.013500   1.000  1.000

05020700 5B   Cabbage, Chinese, bok choy         0.013500   1.000  1.000

05010710 5A   Cabbage, Chinese, napa             0.013500   1.000  1.000

05010720 5A   Cabbage, Chinese, mustard          0.013500   1.000  1.000

05010830 5A   Cauliflower                        0.013500   1.000  1.000

06030980 6C   Chickpea, seed                     0.027000   1.000  1.000

06030981 6C   Chickpea, seed-babyfood            0.027000   1.000  1.000

06030990 6C   Chickpea, flour                    0.027000   1.000  1.000

05021170 5B   Collards                           0.013500   1.000  1.000

13021360 13B  Currant                            7.800000   1.000  1.000

13021370 13B  Currant, dried                     7.800000   1.000  1.000

13021490 13B  Elderberry                         7.800000   1.000  1.000

01011680 1AB  Ginseng, dried                     4.500000   1.000  1.000

13021740 13B  Gooseberry                         7.800000   1.000  1.000

95001790 O    Grape, wine and sherry             3.000000   1.000  1.000

06031820 6C   Guar, seed                         0.027000   1.000  1.000

06031821 6C   Guar, seed-babyfood                0.027000   1.000  1.000

13021910 13B  Huckleberry                        7.800000   1.000  1.000

05021940 5B   Kale                               0.013500   1.000  1.000

05011960 5A   Kohlrabi                           0.013500   1.000  1.000

06032030 6C   Lentil, seed                       0.027000   1.000  1.000

05022290 5B   Mustard greens                     0.013500   1.000  1.000

06022550 6B   Pea, succulent                     0.054000   1.000  1.000

06022551 6B   Pea, succulent-babyfood            0.054000   1.000  1.000

06032560 6C   Pea, dry                           0.027000   1.000  1.000

06032561 6C   Pea, dry-babyfood                  0.027000   1.000  1.000

06012570 6A   Pea, edible podded, succulent      0.135000   1.000  1.000

06032580 6C   Pea, pigeon, seed                  0.027000   1.000  1.000

06022590 6B   Pea, pigeon, succulent             0.054000   1.000  1.000

95002630 O    Peanut                             0.020000   1.000  1.000

95002640 O    Peanut, butter                     0.020000   1.890  1.000

95002650 O    Peanut, oil                        0.020000   1.000  1.000

01032960 1C   Potato, chips                      0.020000   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500  1.000

01032980 1C   Potato, flour                      0.020000   1.000  1.000

01032981 1C   Potato, flour-babyfood             0.020000   1.000  1.000

01032990 1C   Potato, tuber, w/peel              0.020000   1.000  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000  1.000

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000  1.000

05023180 5B   Rape greens                        0.013500   1.000  1.000

05023890 5B   Turnip, greens                     0.013500   1.000  1.000

86010000 O    Water, direct, all sources         0.071000   1.000  1.000

86020000 O    Water, indirect, all sources       0.071000   1.000  1.000

Attachment 2.  Residue inputs for the chronic dietary exposure assessments of fluazinam.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FLUAZINAM                          1994-98 data

Residue file: C:\Documents and Settings\mdoherty\My Documents\Chemistry Reviews\DEEM Runs\Fluazinam\129098c.R98

                                                           Adjust. #2 NOT used

Analysis Date 07-17-2007             Residue file dated: 07-17-2007/10:28:39/8

Reference dose (RfD) = 0.011 mg/kg bw/day

Comment:aPAD of 0.5 kg/day is for general pop.  Female 13-49 aPAD = 0.07 mg/day

------------------------------------------------------------------------ --------

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

-------- ---- -------------------------------   ---------- ------     ------   -------

06030300 6C   Bean, black, seed                  0.027000   1.000      1.000

06020310 6B   Bean, broad, succulent             0.054000   1.000      1.000

06030320 6C   Bean, broad, seed                  0.027000   1.000      1.000

06020330 6B   Bean, cowpea, succulent            0.054000   1.000      1.000

06030340 6C   Bean, cowpea, seed                 0.027000   1.000      1.000

06030350 6C   Bean,  great northern, seed        0.027000   1.000      1.000

06030360 6C   Bean, kidney, seed                 0.027000   1.000      1.000

06020370 6B   Bean, lima, succulent              0.054000   1.000      1.000

06030380 6C   Bean, lima, seed                   0.027000   1.000      1.000

06030390 6C   Bean, mung, seed                   0.027000   1.000      1.000

06030400 6C   Bean, navy, seed                   0.027000   1.000      1.000

06030410 6C   Bean, pink, seed                   0.027000   1.000      1.000

06030420 6C   Bean, pinto, seed                  0.027000   1.000      1.000

06010430 6A   Bean, snap, succulent              0.135000   1.000      1.000

06010431 6A   Bean, snap, succulent-babyfood     0.135000   1.000      1.000

13020570 13B  Blueberry                          7.800000   1.000      1.000

13020571 13B  Blueberry-babyfood                 7.800000   1.000      1.000

05010610 5A   Broccoli                           0.013500   1.000      1.000

05010611 5A   Broccoli-babyfood                  0.013500   1.000      1.000

05010620 5A   Broccoli, Chinese                  0.013500   1.000      1.000

05020630 5B   Broccoli raab                      0.013500   1.000      1.000

05010640 5A   Brussels sprouts                   0.013500   1.000      1.000

05010690 5A   Cabbage                            0.013500   1.000      1.000

05020700 5B   Cabbage, Chinese, bok choy         0.013500   1.000      1.000

05010710 5A   Cabbage, Chinese, napa             0.013500   1.000      1.000

05010720 5A   Cabbage, Chinese, mustard          0.013500   1.000      1.000

05010830 5A   Cauliflower                        0.013500   1.000      1.000

06030980 6C   Chickpea, seed                     0.027000   1.000      1.000

06030981 6C   Chickpea, seed-babyfood            0.027000   1.000      1.000

06030990 6C   Chickpea, flour                    0.027000   1.000      1.000

05021170 5B   Collards                           0.013500   1.000      1.000

13021360 13B  Currant                            7.800000   1.000      1.000

13021370 13B  Currant, dried                     7.800000   1.000      1.000

13021490 13B  Elderberry                         7.800000   1.000      1.000

01011680 1AB  Ginseng, dried                     4.500000   1.000      1.000

13021740 13B  Gooseberry                         7.800000   1.000      1.000

95001790 O    Grape, wine and sherry             3.000000   1.000      1.000

06031820 6C   Guar, seed                         0.027000   1.000      1.000

06031821 6C   Guar, seed-babyfood                0.027000   1.000      1.000

13021910 13B  Huckleberry                        7.800000   1.000      1.000

05021940 5B   Kale                               0.013500   1.000      1.000

05011960 5A   Kohlrabi                           0.013500   1.000      1.000

06032030 6C   Lentil, seed                       0.027000   1.000      1.000

05022290 5B   Mustard greens                     0.013500   1.000      1.000

06022550 6B   Pea, succulent                     0.054000   1.000      1.000

06022551 6B   Pea, succulent-babyfood            0.054000   1.000      1.000

06032560 6C   Pea, dry                           0.027000   1.000      1.000

06032561 6C   Pea, dry-babyfood                  0.027000   1.000      1.000

06012570 6A   Pea, edible podded, succulent      0.135000   1.000      1.000

06032580 6C   Pea, pigeon, seed                  0.027000   1.000      1.000

06022590 6B   Pea, pigeon, succulent             0.054000   1.000      1.000

95002630 O    Peanut                             0.020000   1.000      1.000

95002640 O    Peanut, butter                     0.020000   1.890      1.000

95002650 O    Peanut, oil                        0.020000   1.000      1.000

01032960 1C   Potato, chips                      0.020000   1.000      1.000

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500      1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500      1.000

01032980 1C   Potato, flour                      0.020000   1.000      1.000

01032981 1C   Potato, flour-babyfood             0.020000   1.000      1.000

01032990 1C   Potato, tuber, w/peel              0.020000   1.000      1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000      1.000

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000      1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000      1.000

05023180 5B   Rape greens                        0.013500   1.000      1.000

05023890 5B   Turnip, greens                     0.013500   1.000      1.000

86010000 O    Water, direct, all sources         0.017700   1.000      1.000

86020000 O    Water, indirect, all sources       0.017700   1.000      1.000

Attachment 3.  Summary of acute dietary exposure and risk analysis for fluazinam.

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for FLUAZINAM                           (1994-98 data)

Residue file: 129098a.R98                         Adjustment factor #2 NOT used.

Analysis Date: 07-17-2007/10:31:43    Residue file dated: 07-17-2007/10:27:53/8

Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

Daily totals for food and foodform consumption used.

Run Comment: "aPAD of 0.5 kg/day is for general pop.  Female 13-49 aPAD = 0.07

 mg/day"

======================================================================== =======

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aPAD    Exposure   % aPAD    Exposure   % aPAD

                  ---------- --------  ---------- --------  ---------- --------

U.S. Population:

                    0.006015     1.20    0.016307     3.26    0.034661     6.93

All infants:

                    0.015211     3.04    0.025064     5.01    0.054080    10.82

Children 1-2 yrs:

                    0.007019     1.40    0.012500     2.50    0.043972     8.79

Children 3-5 yrs:

                    0.006323     1.26    0.010539     2.11    0.043124     8.62

Children 6-12 yrs:

                    0.004439     0.89    0.007210     1.44    0.020699     4.14

Youth 13-19 yrs:

                    0.003344     0.67    0.006779     1.36    0.018525     3.70

Adults 20-49 yrs:

                    0.005903     1.18    0.017222     3.44    0.034739     6.95

Adults 50+ yrs:

                    0.006933     1.39    0.017895     3.58    0.037081     7.42

Females 13-49 yrs:

                    0.005809     8.30    0.018964    27.09    0.035119    50.17

Attachment 4.  Summary of chronic dietary exposure and risk analysis for fluazinam.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FLUAZINAM                        (1994-98 data)

Residue file name: C:\Documents and Settings\mdoherty\My Documents\Chemistry Reviews\DEEM Runs\Fluazinam\129098c.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 07-17-2007/10:29:17     Residue file dated: 07-17-2007/10:28:39/8

Reference dose (RfD, Chronic) = .011 mg/kg bw/day

COMMENT 1: aPAD of 0.5 kg/day is for general pop.  Female 13-49 aPAD = 0.07 mg/day

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

--------------------------------------   -------------       ---------------

U.S. Population (total)                     0.000953                 8.7%

U.S. Population (spring season)             0.000916                 8.3%

U.S. Population (summer season)             0.001044                 9.5%

U.S. Population (autumn season)             0.000942                 8.6%

U.S. Population (winter season)             0.000905                 8.2%

Northeast region                            0.001055                 9.6%

Midwest region                              0.000848                 7.7%

Southern region                             0.000806                 7.3%

Western region                              0.001206                11.0%

Hispanics                                   0.000735                 6.7%

Non-hispanic whites                         0.001064                 9.7%

Non-hispanic blacks                         0.000546                 5.0%

Non-hisp/non-white/non-black                0.000809                 7.4%

All infants (< 1 year)                      0.001799                16.4%

Nursing infants                             0.000957                 8.7%

Non-nursing infants                         0.002118                19.3%

Children 1-6  yrs                           0.001014                 9.2%

Children 7-12 yrs                           0.000617                 5.6%

Females 13-19 (not preg or nursing)         0.000429                 3.9%

Females 20+ (not preg or nursing)           0.001178                10.7%

Females 13-50 yrs                           0.000992                 9.0%

Females 13+ (preg/not nursing)              0.000526                 4.8%

Females 13+ (nursing)                       0.000633                 5.8%

Males 13-19 yrs                             0.000445                 4.0%

Males 20+ yrs                               0.000914                 8.3%

Seniors 55+                                 0.001145                10.4%

Children 1-2 yrs                            0.001133                10.3%

Children 3-5 yrs                            0.000996                 9.1%

Children 6-12 yrs                           0.000650                 5.9%

Youth 13-19 yrs                             0.000438                 4.0%

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Adults 20-49 yrs                            0.000996                 9.1%

Adults 50+ yrs                              0.001123                10.2%

Females 13-49 yrs                           0.001016                 9.2%

------------------------------------------------------------------------ -------

Fluazinam 	Dietary Exposure and Risk Assessment	DP Number:  340854

PC Code:  129098

 PAGE

Page   PAGE  1  of   NUMPAGES  12

DRAFT – Confidential, Internal, and Deliberative Material

[Chemical Name]	Dietary Exposure and Risk Assessment	DP Number: [xxxxxxx]

PC Code:  [xxxxxx]


[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47590-47591]
[FR Doc No: 2017-21997]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81827; File No. SR-CBOE-2017-063]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to the Fees Schedule

October 5, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 29, 2017, Chicago Board Options Exchange,
Incorporated (the ``Exchange'' or ``CBOE'') filed with the Securities
and Exchange Commission (the ``Commission'') the proposed rule change
as described in Items I, II, and III below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange seeks to amend the Fees Schedule.
    The text of the proposed rule change is available on the Exchange's
Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx),
at the Exchange's Office of the Secretary, and at the Commission's
Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend its Fees Schedule, effective October
2, 2017. Specifically, the Exchange proposes to amend its marketing fee
program to assess the fee in Russell 2000 Index (``RUT'') options at a
rate of $0.30 per contract. The Exchange currently assess its marketing
fee for penny classes at a rate of $0.25 and non-penny classes at the
rate of $0.70 per contract. CBOE believes assessing the marketing fee
in RUT options will allow CBOE Market-Makers (including DPMs, PMMs, and
LMMs) to compete better for order flow in RUT options. Footnote 6 of
the Fees Schedule currently exempts Underlying Symbol List A symbols
from the marketing fee. Footnote 34 of the Fees Schedule identifies RUT
as an Underlying Symbol List A symbol. Thus, the Exchange is amending
footnote 6 of the Fees Schedule to provide that the marketing fee will
apply to RUT. RUT will remain an Underlying Symbol List A symbol in all
other respects.
    The Exchange also proposes to make a non-substantive amendment to
the term `binaries' in footnote 6 of the Fees Schedule.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\3\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \4\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \5\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
    \5\ Id.
---------------------------------------------------------------------------

    In particular, the Exchange believes applying the marketing fee to
RUT options is equitable, reasonable, and not unfairly discriminatory
as the marketing fee to be applied to RUT options is similar to the
marketing fee currently

applicable to penny and non-penny classes.

B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange does not believe
that the proposed rule change will impose any burden on intramarket
competition that is not necessary or appropriate in furtherance of the
purposes of the Act because, while different fees are assessed to
different market participants in some circumstances, these different
market participants have different obligations and different
circumstances as discussed above. For example, Market-Makers have
quoting obligations that other market participants do not have. The
Exchange does not believe that the proposed rule changes will impose
any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because RUT is
exclusively listed on CBOE and C2. To the extent that the proposed
changes make CBOE a more attractive marketplace for market participants
at other exchanges, such market participants are welcome to become CBOE
market participants.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received comments on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \6\ and paragraph (f) of Rule 19b-4 \7\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2017-063 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2017-063. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2017-063 and should be
submitted on or before November 2, 2017.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-21997 Filed 10-11-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 215 (Thursday, November 6, 2014)]
[Notices]
[Pages 66029-66030]
[FR Doc No: 2014-26358]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-130]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

-----------------------------------------------------------------------

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before November 26, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2000-
8093 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Brenda Robeson, ARM-210, Federal
Aviation Administration, Office of Rulemaking, 800 Independence Ave.
SW., Washington, DC 20591; email<EMAIL_ADDRESS>(202) 267-
4712.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on November 3, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition For Exemption

    Docket No.: FAA-2000-8093.
    Petitioner: The Department of the Air Force.
    Section of 14 CFR Affected: Sec. Sec.  91.179(b)(1); 91.177(a)(2)
14 CFR.
    Description of Relief Sought:
    Due to technological advances in aircraft systems, as well as
current and future operational requirements, the Air Force has the need
to train aircrew and employ aircraft systems at lower

altitudes and greater distances than granted in the current exemption.

[FR Doc. 2014-26358 Filed 11-5-14; 8:45 am]
BILLING CODE 4910-13-P


P-20-0008 Sanitized Support Documents Index:
 P-20-0008 Sanitized Determination Document (linked)
 P-20-0008 Sanitized CHEM Report (attached)
 P-20-0008 Sanitized ECO Report (attached)
 P-20-0008 Sanitized ENG Report (attached)
 P-20-0008 Sanitized EXP Report (attached)
 P-20-0008 Sanitized Fate Report (attached)
 P-20-0008 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Page 15601]
[FR Doc No: 2015-06667]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2014-0042; FRL-9923-15-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for Lime Manufacturing (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NSPS for Lime Manufacturing (40
CFR part 60, subpart HH) (Renewal)'' (EPA ICR No. 1167.11, OMB Control
No. 2060-0063) to the Office of Management and Budget (OMB) for review
and approval in accordance with the Paperwork Reduction Act (44 U.S.C.
3501 et seq.). This is a proposed extension of the ICR, which is
currently approved through May 31, 2015. Public comments were
previously requested via the Federal Register (79 FR 30117) on May 27,
2014 during a 60-day comment period. This notice allows for an
additional 30 days for public comments. A fuller description of the ICR
is given below, including its estimated burden and cost to the public.
An Agency may not conduct or sponsor and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.

DATES: Additional comments may be submitted on or before April 23,
2015.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2014-0042, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: 40 CFR part 60, subpart HH applies to each rotary lime
kiln used in the manufacture of lime. Owners or operators of affected
facilities must conduct initial performance tests and continuously
monitor opacity or the appropriate control device operating parameters.
They must comply with an opacity standard and a moss particulate
standard. Sources are also required to submit semiannual reports.
    Form Numbers: None.
    Respondents/affected entities: Lime manufacturing facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart HH).
    Estimated number of respondents: 41 (total).
    Frequency of response: Initially, occasionally and semiannually.
    Total estimated burden: 3,772 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $440,817 (per year), includes $61,500
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is no change in the labor hours in
this ICR compared to the previous ICR.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-06667 Filed 3-23-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 133 (Wednesday, July 11, 2012)]
[Notices]
[Pages 40928-40929]
[FR Doc No: 2012-16881]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67357; File No. SR-C2-2012-011]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Order Granting Approval of Proposed Rule Change To Implement a Disaster
Recovery Facility

 July 5, 2012.

I. Introduction

    On May 14, 2012, C2 Options Exchange, Incorporated (``Exchange'' or
``C2'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to implement a disaster recovery facility
(``DRF''). The proposed rule change was published for comment in the
Federal Register on May 23, 2012.\3\ The Commission received no
comments on the proposal. This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 67008 (May 17,
2012), 77 FR 30571 (May 23, 2012) (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposal

    As set forth in proposed Exchange Rule 6.45 and the Notice, C2 has
proposed to operate a DRF and adopt a rule governing its use.\4\ The
DRF is designed to allow the Exchange to continue to operate a
marketplace for trading its exclusively-listed options (``ELOs'') \5\
in the event that its main trading system becomes inoperable or
otherwise unavailable due to a disaster or other unusual
circumstance.\6\ The DRF would provide a venue for investors to open
and close positions in ELOs traded on C2 (e.g., SPXPM) in the event
that the main C2 system became inoperable.\7\ To operate the DRF, the
Exchange would use hardware located in the Chicago Board Options
Exchange, Incorporated (``CBOE'') building in Chicago, Illinois.\8\
C2's main trading engine is located on the East Coast, thus there would
be geographic diversity between the DRF and the main C2 trading
system.\9\ The Exchange has represented that the DRF would have the
necessary systems capacity to handle trading in the event that use of
the DRF becomes necessary.\10\
---------------------------------------------------------------------------

    \4\ See C2 Rule 6.45.
    \5\ An ELO is an option that trades exclusively on C2 because C2
has an exclusive license to list and trade such option, or has
proprietary rights in the interest underlying the option. When C2
filed this proposed rule change, it only listed and traded one ELO:
SPXPM, which are Standard & Poor's 500 Index options with third-
Friday-of-the-month expiration dates for which the exercise
settlement value is based on the index value derived from the
closing prices of component securities. See Notice, supra note 3, 77
FR at 30571.
    \6\ See Notice, supra note 3, 77 FR at 30571; proposed C2 Rule
6.45(a).
    \7\ See Notice, supra note 3, 77 FR at 30571.
    \8\ See id.
    \9\ See id.
    \10\ See id.
---------------------------------------------------------------------------

    All C2 Trading Permit Holders (``TPH''),\11\ including those that
may not also be a CBOE TPH, would have access to the DRF.\12\ Each TPH
would be required, as instructed by the Exchange, to take appropriate
actions in order to be able to trade options through the DRF, which
actions would include completion of an Exchange certification process
to ensure that TPHs are prepared to migrate to the DRF if and when
necessary.\13\ The Exchange has represented that it would continuously
maintain the DRF so that it would always be available for use if
needed.\14\ The Exchange has represented further it has written
supervisory procedures in place that would cover activation and use of
the DRF, which would help ensure an efficient transition to the
DRF.\15\
---------------------------------------------------------------------------

    \11\ See C2 Rule 1.1 (defining ``Trading Permit Holder'').
    \12\ See Notice, supra note 3, 77 FR at 30571.
    \13\ See C2 Rule 6.45(d).
    \14\ See Notice, supra note 3, 77 FR at 30571.
    \15\ See id.
---------------------------------------------------------------------------

    As soon as practicable after an event that rendered the main C2
system inoperable or otherwise unavailable, but prior to commencing
trading on the DRF, the Exchange would announce publicly the option
classes that would be available for trading on the DRF.\16\ C2 has
represented that trading on the DRF would be identical to trading on
the Exchange.\17\ For example, all trading and non-trading rules of the
Exchange, including its fee schedule, would continue to apply to option
classes traded on the DRF.\18\ Quote and trade information also would
continue to be reported to the Options Price Reporting Authority
(``OPRA'') in the same manner as for regular trading on C2.\19\ Trading
would transition back to the main C2 system as soon as it becomes
operational.
---------------------------------------------------------------------------

    \16\ See C2 Rule 6.45(b).
    \17\ See Notice, supra note 3, 77 FR at 30571.
    \18\ See C2 Rule 6.45(c).
    \19\ The Exchange represented that any ELO traded on the DRF
would continue to reflect C2 as the exchange venue on the public
tape. See Email from Angelo Evangelou, CBOE, to Commission staff
dated February 7, 2012. In addition, the Exchange has represented
that if C2 shuts down its main trading system during trading hours
and subsequently migrates to the DRF, the regulatory data for the
portion of the day that the main trading system was operating would
be backed-up and available remotely. See Email from Angelo
Evangelou, CBOE, to Commission staff dated July 3, 2012.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\20\ Specifically, the Commission finds that the proposal is
consistent with Section 6(b)(1) of the Act,\21\ which requires that an
exchange be organized and have the capacity to be able to carry out the
purposes of the Act and to comply, and to enforce compliance by its
members and persons associated with its members, with the provisions of
the Act, the rules and regulations thereunder, and the rules of the
Exchange. The Commission believes that proposed Exchange Rule 6.45
provides a business continuity plan that is reasonably designed to
allow the Exchange to continue trading its ELOs in the event that a
disaster or other unusual circumstance renders the main C2 systems
inoperable for continued trading. Specifically with respect to ELOs,
continued trading on the DRF following a disruption that affects C2's
main trading systems will provide market participants and investors
with continued access to a marketplace to open, close, and trade
positions in C2's ELOs. In the absence of adequate DRF facilities and
procedures, market participants could be adversely affected by an
inability to transact in such ELOs.
---------------------------------------------------------------------------

    \20\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \21\ 15 U.S.C. 78f(b)(1).
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    The Commission notes that the details of the Exchange's proposal
are consistent with the key elements set forth in the 2003 Policy
Statement on Business Continuity Planning for Trading Markets, which
directed SRO trading markets and electronic communication networks to
take steps to develop procedures to minimize the potential disruption
and market impact that could result from an event that interrupts the
ability of market participants to utilize their trading systems.\22\
Among other things, C2's proposal provides for geographic diversity
between the DRF and C2's main trading system; references the written
supervisory procedures to govern the operation of the DRF;

establishes a process to ensure that TPHs will be ready to trade on the
DRF if and when necessary; and contemplates public notice when a
transition to trading on the DRF becomes necessary.\23\ Accordingly,
the Commission believes that C2's DRF should enable C2 to continue to
offer a marketplace for trading its ELOs promptly after an event that
disables C2's main trading system in a manner that is designed to
minimize potential disruption and market impact.
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    \22\ See Securities Exchange Act Release No. 48545 (September
25, 2003), 68 FR 56656 (October 1, 2003) (File No. S7-17-03)
(Business Continuity Planning for Trading Markets) (``Policy
Statement'').
    \23\ See Policy Statement, supra note 22, 68 FR at 56658.
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    In addition, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\24\ which requires, among
other things, that the rules of a national securities exchange be
designed to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
Specifically, the Commission finds the proposed rule change is
reasonably designed to facilitate transactions by providing market
participants with the necessary disclosure to understand the Exchange's
operational capabilities and plans with respect to its ELOs in the
event of a disruption to C2's main trading systems.
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    \24\ 15 U.S.C. 78f(b)(5).
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\25\ that the proposed rule change (SR-C2-2012-011) be, and it
hereby is, approved.
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    \25\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
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    \26\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-16881 Filed 7-10-12; 8:45 am]
BILLING CODE 8011-01-P