Nominating Party: 	The United States of America

FILE NAME: 	USA CUN13 Soil peppers Open Field

Brief descriptive Title of Nomination:

Methyl Bromide Critical Use Nomination for Preplant Soil Use for Peppers
Grown in Open Fields (Submitted in 2011 for 2013 Use Season)

Crop name (open field or protected): Peppers Open Field

Quantity of methyl bromide requested:

Table 1: Quantity of Methyl Bromide Requested in Each Year of Nomination

Year	Nomination Amount (Kilograms)

2013	5,673 kg

NOMINATING PARTY CONTACT DETAILS:

Contact Person:	John Thompson

Title:	Division Director

Address:	Office of Environmental Policy

	U.S. Department of State

	2201 C Street, N.W. Room 2658

	Washington, D.C. 20520

	U.S.A.

Telephone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

E-mail:	  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
Following the requirements of Decision IX/6 paragraph (a)(1) The United
States of America has determined that the specific use detailed in this
Critical Use Nomination is critical because the lack of availability of
methyl bromide for this use would result in a significant market
disruption.     .                 ■  Yes  	     ( No

Signature			       	Name					Date

Title:

 (Details on this page are requested under Decision Ex. I/4(7), for
posting on the Ozone Secretariat website under Decision Ex. I/4(8).)

This form is to be used by holders of single-year exemptions to reapply
for a subsequent year’s exemption (for example, a Party holding a
single-year exemption for 2005 and/or 2006 seeking further exemptions
for 2007).  It does not replace the format for requesting a critical-use
exemption for the first time.

In assessing nominations submitted in this format, TEAP and MBTOC will
also refer to the original nomination on which the Party’s first-year
exemption was approved, as well as any supplementary information
provided by the Party in relation to that original nomination.  As this
earlier information is retained by MBTOC, a Party need not re-submit
that earlier information.

CONTACT OR EXPERT(S) FOR FURTHER TECHNICAL DETAILS:

Contact/Expert Person:	Jack Housenger

Title:	Director

Address:	Biological and Economic Analysis Division

	Office of Pesticide Programs

	U.S. Environmental Protection Agency

	1200 Pennsylvania Avenue, N.W. Mailcode 7503P

	Washington, D.C. 20460

	U.S.A.

Telephone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

E-mail:	  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

LIST OF DOCUMENTS SENT TO THE OZONE SECRETARIAT IN OFFICIAL NOMINATION
PACKAGE:

1.  PAPER DOCUMENTS:

Title of paper documents and appendices	No. of pages	Date sent to Ozone
Secretariat

USA CUN13 Soil peppers Open Field 	15

	2.  ELECTRONIC COPIES OF ALL PAPER DOCUMENTS:

*Title of each electronic file (for naming convention see notes above)
No. of kilobytes 	Date sent to Ozone Secretariat

USA CUN13  Soil peppers Open field

* Identical to paper documents

METHYL BROMIDE CRITICAL USE RENOMINATION FOR Preplant Soil Use (OPEN
FIELD OR PROTECTED ENVIRONMENT)

PEPPERS

SUMMARY OF THE NEED FOR METHYL BROMIDE AS A CRITICAL USE:

This renomination covers only peppers grown in the southeastern US,
Georgia, Florida,. These crops generally are grown in open fields on
plastic tarps, often followed by various other crops.  Harvest is
destined for the fresh market.

Only areas that cannot use alternative fumigants or non-fumigant options
have been included in the calculation of nominated amounts and area to
be treated. The applicants’ requests have also been adjusted downward
to account for the lower methyl bromide dose rates (see BUNNIE in
Appendix A) for the southern regions of US pepper production, since
increased use of high barrier films in conjunction with lower rates has
been reported there.

The USG has reviewed all factors affecting transition rates in this
sector. Based on this assessment the transition rate has been greatly
increased for most portions of this sector.  For the area covered in
this nomination, the USG believes that the narrative discussion included
in this document is technically valid. The USG has nominated amounts of
methyl bromide based only on those sub-sectors that cannot transition
away from methyl bromide at the accelerated rate.

In developing this renomination the USG examined several recent studies
to determine whether yield losses and market window losses associated
with the best available fumigant alternative could be altered from
previous nominations. Unfortunately none of the studies located by the
USG met the criteria that earlier cited studies did. These criteria
include: the use of fumigant alternatives registered for the crop
nominated, the presence of both a methyl bromide standard and an
untreated control as treatments as well as the monitoring of yields
under each treatment. Several such studies included a methyl bromide
treatment or an untreated control but not both, or included both but did
not monitor yield, or included unregistered alternatives. However,
research conducted at the University of Georgia that examined use of a
three way combination of alternative fumigants (1,3 D followed by
chloropicrin followed by metam-sodium) did meet these criteria,
Therefore, nominations for the southern US areas were adjusted to
reflect the apparent technical feasibility of this three way combination
of alternative fumigants under VIF or metallized films,  as a
replacement for spring-time applications of methyl bromide+chloropicrin,
after accounting for areas in the south that face prohibition of 1,3-D
due to the presence of karst topographical features.

The recent renewal of the federal registration of iodomethane, along
with its registration at the state level in all the pepper producing
regions covered by this nomination, will be factored into calculations
of the total amount of methyl bromide being requested for peppers. This
calculation takes into account the issue that time will be needed for
the industry to transition to the use of this material in areas where it
is feasible. This transition is part of the BUNNIE included in Appendix
A.

U.S. reliance on methyl bromide has dramatically and rapidly been
reduced over the last eight years.  Critical use exemption (CUE)
requests have decreased every year since the U.S. phase-out process
began.  The development, registration, and use of new pest control
products and production methods have been key to the progress and
reductions made to-date.  As alternatives have demonstrated their
suitability, as thorough reviews of research results and applicant
information have been conducted, and contacts have been made with
regional crop experts to assess the technical and economic feasibility
of alternatives, U.S. Government (USG) requests have reduced by 99%, for
the fruiting vegetables, over the last 9 years.  However, as the amount
of methyl bromide available for use decreases each year, substantial
challenges exist in the collection of needed data to substantiate
on-going critical needs through the CUE process.

There are now several alternatives for soil fumigation, including
1,3-dichloropropene plus chloropicrin, the “UGA 3 Way” combination
(1,3-dichloropropene plus chloropicrin followed by metam sodium),
iodomethane plus chloropicrin, and dimethyl disulfide (DMDS) which have
demonstrated some technical and economic feasibility for pest control in
a number of vegetable crops in the U.S. Southeast.  However, CUE
applicants in this nominated sector have indicated that they are not
always suitable for all situations.  While DMDS has a Federal
registration and has demonstrated effectiveness, it is not currently
registered in all the relevant states.  Given the timing of state
registrations, lack of experience using this alternative, and
application methods still under development to minimize odor in
communities surrounding treated fields there is uncertainty in
predicting when this alternative can be reasonably expected to
adequately replace methyl bromide in specific application scenarios.
While the DMDS registrant has been working with the product to reduce
the odor, and growers are gaining experience in its use, work is still
needed on application approaches for the alternative to be fully
available for use in U.S. southeast vegetable crops.  For example
individual operators and small farms, which account for up to eighty
percent of the growers in this nominated sector are especially
hard-pressed to make this transition, because one of the most promising
alternatives requires additional money to convert their fumigation
equipment and custom fumigation applicators are not available in all
areas.  In addition to the expense to convert to the alternatives, there
have been reports that the alternatives do not perform as well as the
MeBr:pic combination.

These concerns about the alternatives have only recently been brought to
the USG attention and insufficient supporting information was provided.
Because of the uncertainties and challenges associated with the use of
the available alternatives, the USG believes it most prudent and the
best public policy to collect additional information so that the
technical and economic impacts of these reported problems can be
evaluated.  The USG will request the applicants provide additional
information to us no later than June 1, 2011 so that the information can
be analyzed and provided to MBTOC by July 15, prior to the Open Ended
Work Group (OEWG) meeting in early August.  The quality of any
additional information received will first be evaluated in terms of
whether or not it supports a compelling case and confirms problems with
the feasibility of alternatives. Then, on that basis, the USG will
either support or withdraw this nominated sector at that meeting.

The nomination attached specifies the correct year (2013) and amount of
methyl bromide that is being requested for the individual crops within
this sector.  However, there has been no attempt to update the
information in this document regarding the new research, availability of
alternatives, etc.  Since the USG learned of the issues facing the
growers within this sector, after speaking directly with researchers
familiar with the specific problems only very recently, this information
was not available at the time the USG recommendation was developed.

2.	SUMMARIZE why KEY alternatives are not feasible

The U.S. nomination is only for those areas where the alternatives are
not suitable.  In U.S. pepper production there are several factors that
make the potential alternatives to methyl bromide unsuitable.  These
include:

Pest control efficacy of alternatives: the efficacy of alternatives may
not be comparable to methyl bromide in some areas, making these
alternatives technically and/or economically infeasible for use in
pepper production.

Geographic distribution of key target pests: i.e., some alternatives may
be comparable to methyl bromide as long as key pests occur at low
pressure, and in such cases the U.S. is only nominating a CUE for
peppers where the key pest pressure is moderate to high such as nutsedge
in the Southeastern U.S.

Regulatory constraints: e.g., 1,3 D use is limited in Georgia and
Florida due to the presence of karst topography.

Infeasibility of fall-season fumigation in the southeastern US, even
with the best available combination of alternatives (1,3 D followed by
chloropicrin followed by metam-sodium).

There are significant restrictions on which crops can be rotated through
after use of a given alternative (e.g., halosulfuron has rotational
restrictions that prevent its use in southeastern US tomatoes).

Resistance management prevents use of the alternative (e.g., glyphosate
resistant weeds, such as Amaranth, in the southern US, prevent use of
this alternative as a post-emergent weed control in those regions).

Florida, Georgia, and the Southeastern U.S. (outside Florida and
Georgia) are each presented as separate regions in this nomination to
reflect the separate applications from growers in these areas. In this
nomination, the Southeastern U.S. includes the following states:
Alabama, Arkansas, Kentucky, Louisiana, Mississippi, North Carolina,
South Carolina, Tennessee, and Virginia. A brief description of their
need for methyl bromide follows, also presented on a regional basis.

3.	is the use covered by A certification STANDARD?

Methyl bromide is not used to meet a certification standard for pepper
vegetable production.

4.	If part of the crop area is treated with methyl bromide, indicate the
reason why methyl bromide is not used in the other area, and identify
what alternative strategies are used to control the target pathogens and
weeds without methyl bromide there.

In southeastern U.S., Florida, and Georgia, areas not treated have low
levels of nutsedge or nematodes in pepper fields

5.	Would it be feasible to expand the use of these methods to cover at
least part of the crop that has requested use of methyl bromide? What
changes would be necessary to enable this?

Better, more consistent pest control efficacy from the alternatives
would be required.

The USG has reviewed all factors affecting transition rates in this
sector. Based on this assessment the transition rate has been greatly
increased for most portions of this sector.  For the area covered in
this nomination, the USG believes that the narrative discussion included
in this document is technically valid. The USG has nominated amounts of
methyl bromide based only on those sub-sectors that cannot transition
away from methyl bromide at the accelerated rate.

6.	SUMMARY OF RECENT RESEARCH

As mentioned earlier in this document, iodomethane formulated with
chloropicrin has shown good efficacy against key pepper pests, including
nutsedge, in a number of trials with peppers and related vegetables such
as tomatoes (e.g., Louws et al. 2006, Culpepper 2006, 2007, 2008,
Culpepper et al. 2008, Olsen 2008). Iodomethane had time limitations
removed from its federal label in October, 2008, and has received
state-level approval in 47 US states (California, Washington, and New
York are the exceptions at this time).  However, other important
constraints must be considered when assessing the feasibility of
iodomethane as a methyl bromide alternative. These include: (1) the cost
of iodomethane formulations is higher than methyl bromide, and will
probably remain so for the next several years, (2) growers and
researchers will need time to evaluate iodomethane use in the various
local production conditions covered by this nominations, and (3) growers
and applicators will need to make some equipment modifications to adapt
to the lower flow rates typical with less expensive iodomethane
application rates and to avoid the corrosion of some metals that can
occur with iodomethane (Sumner 2005, Noling et al. 2006).  The economic
impact of using iodomethane is further described in Part E of this
document (below). A consideration of these aspects has led the USG to
conclude that while iodomethane appears to be technically feasible to
manage key pepper pests in all parts of the US where it has been
registered, time will be needed for growers and extension service
experts to adapt its use successfully. Therefore, the amount of methyl
bromide nominated for peppers has been adjusted downward while also
considering the time needed to transition to iodomethane.

In the short term, and in situations where pepper producers cannot use
iodomethane, the USG concludes that other fumigant alternatives to
methyl bromide would have to be used. The details of this conclusion are
similar to the previous year’s pepper CUN, and are further discussed
below.

Narrative description of studies relevant to key weeds and nematodes

For nutsedge pests, which are widespread in all requesting regions,
pepper growers do not currently have technically feasible alternatives
to methyl bromide use at planting.  Metam-sodium and 1,3 D +
chloropicrin have shown some efficacy in small-plot trials in other
vegetable crops (e.g, tomato).  However, at best, metam sodium may allow
at least 44 % yield loss, while 1,3 D may allow at least 29 % loss.
Both often show less control than methyl bromide (in terms of population
suppression) of nutsedges.  These factors suggest that even this
alternative will not be economically feasible even in the best-case
technical scenario.  It should be noted also that there is evidence that
both 1,3 D and methyl isothiocyanate levels decline more rapidly, thus
further compromising efficacy, in areas where these are repeatedly
applied (Smelt et al., 1989; Ou et al., 1995; Gamliel et al., 2003).
This is probably due to enhanced degradation of these chemicals by soil
microbes (Dungan and Yates, 2003).

Other chemical alternatives to methyl bromide that have shown promise
against nutsedges and nematodes (e.g., pebulate and dimethyl disulfide)
are currently unregistered for peppers,

In one recent study, Culpepper and Langston (2004) conducted studies at
2 sites in spring 2003 and one site in the fall season of 2004.  Plot
sizes were 20 feet X 32 inches (4.94 m2).  Treatments were: Methyl
bromide standard (67:33 formulation), untreated control, 2 formulations
of Telone (1,3 D + chloropicrin) at various doses, followed by an
additional application of either chloropicrin or metam-sodium, a third
formulation of 1,3 D + chloropicrin (“Inline”), and iodomethane.  An
additional set of plots received the same fumigant treatments but also
received an herbicide treatment (clomazone + halosulfuron) later in the
season.

Some important caveats must be mentioned when considering these results:

Plots used were quite small, and it is not at all clear if the promising
results will hold reliably in larger commercial fields.  This is
particularly worrisome given the highly variable results reported by
other researchers for the same methyl bromide alternatives.

The nutsedge populations in this study were dominated by yellow nutsedge
(90 % of the total number).  It is not clear if populations where purple
nutsedge is dominant will be controlled as effectively.  A number of
other studies have indicated that purple nutsedge is a hardier species,
and even in Culpepper and Langston’s study, it appeared more resistant
to the methyl bromide alternatives.  For example, iodomethane gave “77
% control” of yellow nutsedge, but only “37 % control” of purple
nutsedge.  Control in this case was apparently defined as the reduction
in nutsedge populations as compared to populations in the untreated
control.

Another recent study of methyl bromide alternatives involving key weed
pests was done by Gilreath et al. 2005 (Crop Prot (24): 903-908). One of
3 trials in that study showed an average of 30 % lower bell pepper
yields with nutsedge and nematodes as the key pests present.  In the
other 2 trials yields were not significantly different across different
fumigant treatments, but nutsedge pressure was lower in those trials as
compared to the third. Other important caveats to these results are -
this was a small-plot study and was done in Florida. Thus it is not
clear how applicable the results are to the more northern regions
requesting methyl bromide for vegetable crops (e.g., Delaware, Maryland,
and Virginia).

In addition to the studies described above, several other recent studies
conducted in the production circumstances of the southeastern US have
examined several fumigant alternatives to methyl bromide, most done in
crops other than peppers (e.g., Santos et al. 2006, Candole et al. 2007,
Santos and Gilreath 2007, Gilreath and Santos 2005, 2007). These studies
either focused solely on nutsedge weeds or a combination of nutsedges,
diseases, and nematodes. However, USG has examined these papers and
concludes that for peppers, these studies do not meet all the criteria
that allowed the use of earlier studies in estimating yield and quality
losses that may occur if such methyl bromide alternatives are used as
direct replacements for methyl bromide.

These criteria are: the use of fumigant alternatives registered for the
crop nominated, the presence of both a methyl bromide standard and an
untreated control as treatments as well as the monitoring of yields
under each treatment. Several such studies included a methyl bromide
treatment or an untreated control but not both (Santos and Gilreath
2007, Johnson and Mullinix 2007), or included both but did not monitor
yield (Candole et al. 2007), or included unregistered alternatives
(e.g., Gilreath and Santos 2005, 2007, Santos et al. 2006). While these
studies (the majority of which were small-plot trials) indicate
continued promise of methyl bromide alternatives such as 1,3-D,
metam-sodium, chloropicrin, herbicides, or combinations thereof, they
cannot yet be used to alter yield estimates.

Therefore,  for this nomination, the USG concludes that, for pepper
growers who can only use either 1,3-D + chloropicrin or
metam-sodium+chloropicrin in fall-season fumigations to control nutsedge
and nematode pests, the yield loss estimates used in last year’s
nomination continue to be applicable. These loss estimates are
illustrated in Table 2 below, and are used as the basis of part of the
economic assessment in the following section.

Table 2. data on yield losses with likely methyl bromide alternatives
and nutsedge present as a crop pest.

Chemicals	Rate (kg/ha)	Average Nutsedge Density

(#/m2)	Average Marketable Yield

(ton/ha)	% Yield Loss (compared to MB)

Untreated (control)	-	300 ab	20.1 a	59.1

methyl bromide + Pic (67-33), chisel-injected	390 kg	 90 c	49.1 b	---

1,3 D + Pic (83-17), chisel-injected	327 l	340 a	34.6 c	29.5

Metam Na, Flat Fumigation	300 l	320 a	22.6 a	54.0

Metam Na, drip irrigated	300 l	220 b	32.3 c	34.2

Locascio et al. 1997.

Recent studies that are useful (within the context of this nomination)
in assessing technical feasibility of a combination of methyl bromide
alternatives include the series of trials being conducted by Culpepper
et al. at the University of Georgia (e.g., Culpepper 2006, Culpepper et
al. 2007a,b, Culpepper 2008). These studies indicate that a 3-way,
sequential combination of several fumigant alternatives is technically
feasible for spring-time fumigation of most vegetable crops. The 3-way
combination consists of 1,3 D  followed by chloropicrin at about 168
kg/ha, followed by metam-sodium, all under VIF or metallized (high
barrier) tarps, and will henceforth be referred to as the ‘UGA 3
way’, as Culpepper et al. have. An example of the results obtained in
spring fumigation with this combination in peppers is presented in the
table below. Also see several research reports available from the
University of Georgia at   HYPERLINK "http://www.gaweed.com"
www.gaweed.com ).

Table 3.  Number of Pepper Fruit - Methyl Bromide: Chloropicrin Versus
Three Way Combination.  Spring 2006

Fruit Size	Methyl Bromide : Chloropicrin

(# of Fruit)	UGA 3 way

1,3-D fb chloropicrin fb metam Na

Jumbo	30 b	125 a

X-Large	219 a	237 a

Large	153 a	143 a

Chopper	217 a	252 a

Cull	11 a	9 a

Jumbo + X-Large + Large	402 b	505 a

Footnote:  Culpepper 2006.   fb means followed by or a sequential
treatment. Plots were 3 rows by 100 feet long.

Since Georgia is similar to other areas of the southeastern US, except
Maryland/Delaware peppers which face a different key pest (F. oxysporum
niveum), these results should be applicable to spring usage of methyl
bromide in these regions. However, other results thus far indicate that
summer/fall fumigation is not similarly effective with this combination
of alternatives (Culpepper, personal communication, Culpepper 2006,
2008).

Results of one of several experiments conducted by Culpepper et al. at
the University of Georgia illustrate the infeasibility of the use of the
‘UGA 3 way’ method in place of methyl bromide for fall-season
fumigations in vegetable production. In this experiment, fields were
fumigated during for fall-season crop production on July 17 2007.  Soil
temperature was 84 degrees at 8 inches. The experiment consisted of 4
fumigant treatments (Table 4) that were replicated three times. Even
under high-barrier film (“Blockade”), the ‘UGA 3 way’ gave less
control of purple nutsedge as compared to the methyl bromide standard
under the same type of film. Yields were consistently lower with the
‘UGA 3 way’ as well, with a roughly 50 % reduction in both number
and weight of harvested vegetables (Table 4). The economic implications
of this level of yield loss for Georgia pepper growers are further
described in section 7, below.

Table 4.  Comparing methyl bromide and the 3-Way for the control of
nutsedge and pepper yield.

Fumigant	Mulch	Late-season purple nutsedge control	Harvests 1-2

(Jumbo pepper)	Harvests 1-4

(Jumbo pepper)

%	# fruit/plot	lbs/plot	# fruit/plot	lbs/plot

UGA-3 Way	LDPE	48 d	34 c	16 c	44 c	19 c

UGA-3 Way	Blockade	60 c	50 b	24 b	71b	32 b

Methyl Bromide + chloropicrin	Blockade	85 b	106 a	48 a	136 a	61 a

None	LDPE	0 f	13 d	6 d	19 d	8 d

Notes: (1) The UGA 3 Way consisted of 1,3 D at approximately 192 kg/ha,
followed by chloropicrin at 168 kg/ha, followed by metam-sodium at
approximately 358 kg/ha. Methyl bromide + chloropicrin was applied in a
50:50 mix at approximately 160 kg/ha of each. Rates as shown are not
planting bed-strip adjusted.  (2) “Mulch” refers to the tarp type.
LDPE = traditional high permeability tarp; Blockade = low permeability
tarp manufactured by Pliant Corp.

It is important to note that caveats accompany even the technical
feasibility of the ‘UGA 3 way’ use in spring fumigations. Growers
must make several application modifications to properly use the
approach, and this may incur significant capital expenditure. Culpepper
et al. estimate their costs to do this for their research trials at
about $ 15,000 (Culpepper et al. 2007b). Application costs will also
increase as more chemicals and runs of tractor equipment are required to
conduct the ‘UGA 3 way’, and the cost of VIF or metallized film is
between 1.75 and two times greater than standard LBPF (Culpepper,
personal communication).

Time and further research and extension education will also be needed to
implement the ‘UGA 3-way’ method in areas outside Georgia where the
method has been less-studied, and where different problems may need to
be resolved. An example of this issue is illustrated in recent work by
Chellemi et al. (2008). These researchers evaluated the ‘UGA 3 way’
in on-farm tests in Florida peppers. Results of four trials were highly
variable, with two showing better yields than the methyl bromide
standard, and two showing worse results. All four trials showed a
reduction in larger (more profitable) peppers in the ‘UGA 3 way’ as
compared to the methyl bromide standard. The cause appeared to be an
overload of potassium in the soil, created by the combined use of the
metam-potassium in the ‘UGA 3 way’ and the growers’ standard
practice of applying a high-potassium fertilizer.

7.  ECONOMIC FEASIBILITY OF ALTERNATIVES

The following economic analysis is organized by methyl bromide critical
use application regions.

Reader, please note that in this study net revenue is calculated as
gross revenue minus operating costs.  This is a good measure as to the
direct losses of income that may be experienced by the users.  It should
be noted that net revenue does not represent net income to the users.
Net income, which indicates profitability of an operation of an
enterprise, is gross revenue minus the sum of operating and fixed costs.
 Net income should be smaller than the net revenue measured in this
study.  We did not include fixed costs because these costs are often
difficult to measure and verify.

Summary of Economic Feasibility

The economic analysis of pepper applications compared data on the
yields, crop prices, revenues and costs of using methyl bromide or
alternative pest control regimens. This was done in order to estimate
impacts on pepper growers with the decreasing availability of methyl
bromide.  The alternatives identified as technically feasible (in cases
of low pest infestation) for Georgia, Florida, and the Southeaster U.S.
for peppers are: (a) Iodomethane and (b) the Georgia 3-Way Method, which
includes 1,3-dichloropicrin with chloropicrin followed by metam sodium.

The economic reviewers then analyzed crop budgets for pre-plant sectors
to determine the likely economic impact if methyl bromide were
unavailable.  Various measures were used to quantify the impacts,
including the following:

(1) Loss per Hectare.  For crops, this measure is closely tied to
income.  It is relatively easy to measure, but may be difficult to
interpret in isolation.

(2) Loss per Kilogram of Methyl Bromide.  This measure indicates the
value of methyl bromide to crop production.

(3) Loss as a Percentage of Gross Revenue.  This measure has the
advantage that gross revenues are usually easy to measure, at least over
some unit, e.g., a hectare of land or a storage operation.  However,
high value commodities or crops may provide high revenues but may also
entail high costs.  Losses of even a small percentage of gross revenues
could have important impacts on the profitability of the activity.

(4) Loss as a Percentage of Net Operating Revenue.  We define net cash
revenues as gross revenues minus operating costs.  This is a very good
indicator as to the direct losses of income that may be suffered by the
owners or operators of an enterprise.  However, operating costs can
often be difficult to measure and verify.

(5) Operating Profit Margin.  We define operating profit margin to be
net operating revenue divided by gross revenue per hectare.  This
measure would provide the best indication of the total impact of the
loss of methyl bromide to an enterprise.  Again, operating costs may be
difficult to measure and fixed costs even more difficult, therefore
fixed costs were not included in the analysis.

These measures represent different ways to assess the economic
feasibility of methyl bromide alternatives for methyl bromide users, who
are pepper producers in this case.  Because producers (suppliers)
represent an integral part of any definition of a market, we interpret
the threshold of significant market disruption to be met if there is a
significant impact on commodity suppliers using methyl bromide.  The
economic measures provide the basis for making that determination.

Georgia, Florida, and the southeastern u.s.

In Georgia, Florida, and the Southeastern U.S., the Georgia 3-Way on
spring plantings and iodomethane are considered technically and
economically feasible alternatives to methyl bromide, although some
limitations exist. Referring to Table 5, 6, and 7, the loss of net
revenue using the Georgia 3-Way is negligible in Florida and the
Southeastern U.S. in comparison to methyl bromide, while gains in net
revenue are expected in Georgia. Although no gains in gross revenue are
expected when using iodomethane, losses in net revenue are negligible.
One drawback to the Georgia 3-Way is that yield losses are expected in
fall plantings, with studies in Georgia’s application show a 50% yield
loss. These losses are not expected when iodomethane is used. The
Georgia 3-Way also cannot be used on peppers that are grown in karst
soils since it contains 1,3-D; however, iodomethane can be, making
methyl bromide unnecessary for pepper production in areas with karst
topography.  Note that data describing Georgia and Florida pepper
production are based on double cropping production practices.

Table 5. Georgia : Economic Impacts of Methyl Bromide Alternatives

GEORGIA PEPPER 	METHYL BROMIDE	GEORGIA 3-WAY: SPRING APPLICATION
GEORGIA 3-WAY: FALL APPLICATION 	IODOMETHANE

PRODUCTION LOSS (%)	0%	0%	50%	0%

    PRODUCTION PER HECTARE	5,797	5,797	2,899	5,797

* PRICE PER UNIT (US$)	$12	$12	$12	$12

= GROSS REVENUE PER HECTARE (US$)	$67,907	$67,907	$33,954	$67,907

- OPERATING COST PER HECTARE (US$)	$55,279	$41,211	$41,211	$56,433

= NET REVENUE PER HECTARE (US$)	$12,629	$26,696	-$7,258	$11,475

LOSS MEASURES *

1. LOSS PER HECTARE (US$)	$0	-$14,067	$19,886	$1,154

2. LOSS PER KILOGRAM OF METHYL BROMIDE (US$)	$0	-$151	$214	$12

3. LOSS AS A PERCENTAGE OF GROSS REVENUE (%)	0%	-21%	29%	2%

4. LOSS AS A PERCENTAGE OF NET OPERATING REVENUE (%)	0%	-111%	157%	9%

5. OPERATING PROFIT MARGIN (%)	19%	39%	-21%	17%

* Interpret the loss measures with caution. Negative numbers presented
in rows indicating a “loss” should be interpreted as a “gain”.
Positive numbers can be interpreted as losses.

Table 6. Florida:  Economic Impacts of Methyl Bromide Alternatives

FLORIDA PEPPER-DOUBLE CROP	METHYL BROMIDE	GEORGIA 3-WAY	IODOMETHANE

PRODUCTION LOSS (%)	0%	0%	0%

    PRODUCTION PER HECTARE	4,379	4,379	4,379

* PRICE PER UNIT (US$)	$12	$12	$12

= GROSS REVENUE PER HECTARE (US$)	$51,756	$51,756	$51,756

- OPERATING COST PER HECTARE (US$)	$48,934	$49,030	$49,522

= NET REVENUE PER HECTARE (US$)	$2,822	$2,726	$2,234

LOSS MEASURES *

1. LOSS PER HECTARE (US$)	$0	$96	$588

2. LOSS PER KILOGRAM OF METHYL BROMIDE (US$)	$0	$1	$6

3. LOSS AS A PERCENTAGE OF GROSS REVENUE (%)	0%	0%	1%

4. LOSS AS A PERCENTAGE OF NET OPERATING REVENUE (%)	0%	3%	21%

5. OPERATING PROFIT MARGIN (%)	5%	5%	4%

* Interpret the loss measures with caution. Negative numbers presented
in rows indicating a “loss” should be interpreted as a “gain”.
Positive numbers can be interpreted as losses.

Table 7.  Southeastern USA (except Georgia):  Economic Impacts of Methyl
Bromide Alternatives

SOUTHEASTERN USA (EXCEPT GEORGIA) PEPPER	METHYL BROMIDE	GEORGIA 3-WAY
IODOMETHANE

PRODUCTION LOSS (%)	0%	0%	0%

    PRODUCTION PER HECTARE	2,965	2,965	2,965

* PRICE PER UNIT (US$)	$8	$8	$8

= GROSS REVENUE PER HECTARE (US$)	$24,463	$24,463	$24,463

- OPERATING COST PER HECTARE (US$)	$21,955	$22,051	$22,543

= NET REVENUE PER HECTARE (US$)	$2,508	$2,412	$1,920

LOSS MEASURES *

1. LOSS PER HECTARE (US$)	$0 	$96 	$588

2. LOSS PER KILOGRAM OF METHYL BROMIDE (US$)	$0 	$1 	$6

3. LOSS AS A PERCENTAGE OF GROSS REVENUE (%)	0%	0%	2%

4. LOSS AS A PERCENTAGE OF NET OPERATING REVENUE (%)	0%	4%	23%

5. OPERATING PROFIT MARGIN (%)	10%	10%	8%

* Interpret the loss measures with caution. Negative numbers presented
in rows indicating a “loss” should be interpreted as a “gain”.
Positive numbers can be interpreted as losses.

8.  RESULTANT CHANGES TO REQUESTED EXEMPTION QUANTITIES

The USG has applied an aggressive transition rate, which is reflected in
the nomination amount and detailed in Table 8.

Table 8. Nomination Amount:

Citations

Candole, B.L., A.S. Csinos, and D. Wang.  2007.  Concentrations in soil
and efficacy of drip -applied 1,3-D+chloropicrin and metam sodium in
plastic-mulched sandy soil beds. In press at: Crop Prot. (2007),
doi:10.1016/j.cropro.2007.03.021.

Chellemi, D. O.  2008.  Field validation of a fumigant alternative.
Proc. Annual Int. Res. Conf. on Methyl Bromide Alternatives and
Emissions Reductions. Available on the web at   HYPERLINK
"http://mbao.org/2008/008Chellemi.pdf"
http://mbao.org/2008/008Chellemi.pdf .

Culpepper, A.S., P. Sumner, D. Langston, K. Rucker, G. Beard, J.
Mayfield, T. Webster, and W. Upchurch.  2007.  Can Georgia growers
replace methyl bromide? Proc. Annual Int. Res. Conf. on Methyl Bromide
Alternatives and Emissions Reductions. Available on the web at
HYPERLINK "http://mbao.org/2007/Proceedings/mbrpro07.html"
http://mbao.org/2007/Proceedings/mbrpro07.html

Culpepper, A.S., P. Sumner, D.B. Langston, K. Rucker, G. Beard, J.
Mayfield, T. Webster, and W. Upchurch.  2008.  Methyl bromide
alternatives are effective during the spring in Georgia.  From the 2008
Proceedings of the Southeast Regional Vegetable Conference, Georgia,
USA.  Available on the web at:    HYPERLINK
"http://www.tifton.uga.edu/veg/publications.htm"
http://www.tifton.uga.edu/veg/publications.htm

Dungan, R.S. and S.R. Yates.  2003.  Degradation of fumigant Pesticides.
1,3-Dichloropropene, methyl isothiocyanate, and methyl bromide. Vadose
Zone Jour. 2: 279-286.

Gamliel, A., S. Triki, M. Austerweil, P. DiPrimo, I. Peretz-Alon, O.
Heiman, M. Beniches, B. Steiner, and J. Katan.  2003.  Accelerated
degradation of metam sodium in the field and its management. Proc.
Annual Int. Res. Conf. on Methyl Bromide Alternatives and Emissions
Reductions. Available on the web at http://www.mbao.org/mbrpro03.html.

Gilreath, J., J. P. Jones, and A. J. Overman.  1994.  Soil-borne pest
control in mulched tomato with alternatives to methyl bromide. Proc.
Annual Int. Res. Conf. on Methyl Bromide Alternatives and Emissions
Reductions. Available on the web at   HYPERLINK
"http://www.mbao.org/mbrpro94.html"  http://www.mbao.org/mbrpro94.html .

Gilreath, J.P. B.M. Santos, T.M. Motis, J.W. Noling, and J.M. Mirusso.
(2005) Methyl bromide alternatives for nematode and Cyperus control in
bell pepper (Capsicum annuum).  Crop Prot. 24: 903-908.

Hausbeck, M. K. and B. D. Cortwright.  2004.  Evaluation of fumigants
for managing Phytophthora crown and fruit rot of solanaceous and
cucurbit crops, plot two, 2004. Unpublished study supplied with CUE
package 04-0005.

Hausbeck, M. K. and B. D. Cortright.  2007a.  Comparison of low density
polyethylene and virtually impermeable film and their effect on the
efficacy of fumigants for the control of Fusarium on melon. Unpublished
study supplied with Michigan’s CUE package for 2010 (07-0005).

Hausbeck, M. K. and B. D. Cortright.  2007b. Managing melon soil-borne
pathogens in Michigan. Proc. Annual Int. Res. Conf. on Methyl Bromide
Alternatives and Emissions Reductions. Available on the web at
HYPERLINK "http://mbao.org/2007/Proceedings/mbrpro07.html"
http://mbao.org/2007/Proceedings/mbrpro07.html .

Johnson, W.C. and B.G. Mullinix.  2007.  Yellow nutsedge (Cyperus
esculentus) control with metham-sodium in transplanted cantaloupe
(Cucumis melo). Crop Prot. 26: 867-871.

Locascio, S.J., J.P. Gilreath, D.W. Dickson, T.A. Kucharek, J.P. Jones,
and J.W. Noling.  1997.  Fumigant alternatives to methyl bromide for
polyethylene mulched tomato. HortSci. 32: 1208-1211.

Louws, F., J., R.M. Welker, J. Driver, K. Jennings, and D.W. Monks.
2006.  Efficacy of methyl bromide for weed and Verticillium management
in tomatoes. Proc. Annual Int. Res. Conf. on Methyl Bromide Alternatives
and Emissions Reductions. Available on the web at   HYPERLINK
"http://mbao.org/2006/Proceedings/mbrpro06.html"
http://mbao.org/2006/Proceedings/mbrpro06.html .

Noling, J.W., J.P. Gilreath, D. Botts, and C. Hinton.  2006.  Methyl
bromide transition strategies: formulating the message and getting it
out. . Proc. Annual Int. Res. Conf. on Methyl Bromide Alternatives and
Emissions Reductions. Available on the web at   HYPERLINK
"http://mbao.org/2006/Proceedings/mbrpro06.html"
http://mbao.org/2006/Proceedings/mbrpro06.html .

Olsen, B.  2008.  Midas soil fumigant 2008.  Proc. Annual Int. Res.
Conf. on Methyl Bromide Alternatives and Emissions Reductions. Available
on the web at   HYPERLINK
"http://mbao.org/2008/Proceedings/mbrpro08.html"
http://mbao.org/2008/Proceedings/mbrpro08.html .

Ou, L.-T., K.Y.Chung, J.E. Thomas, T.A. Obreza, and D.W. Dickson.1995.
Degradation of 1,3-dichloropropene (1,3-D) in soils with different
histories of field applications of 1,3-D. J. Nematol. 25: 249–257.

Roberts W., B. Bruton, W. Fish, and M. Taylor. 2007. Using grafted
transplants in watermelon production. From the 2007 Proceedings of the
Southeast Regional Vegetable Conference, Georgia, USA. Available on the
web at:    HYPERLINK "http://www.tifton.uga.edu/veg/publications.htm"
http://www.tifton.uga.edu/veg/publications.htm

Santos, B.M. and J.P. Gilreath. 2007. Effects of propylene oxide doses
on Cyperus and Belonolaimus control and nutrient absorption in tomato.
In press at: Crop Prot. (2007), doi:10.1016/j.cropro.2007.03.021.

Santos, B.M., J.P. Gilreath, T.N. Motis, J.W. Noling, J.P. Jones, and
J.A. Norton.  2006.  Comparing Methyl Bromide Alternatives for Soilborne
Disease, Nematode and Weed Management in Fresh Market Tomato. Crop Prot.
25:690-695.

Smelt, J.H., S.J.H. Crum, and W. Teinissen. 1989. Accelerated
transformation of the fumigant methyl isocyanate in soil after repeated
application of metam sodium. J. Environ. Sci. Health B24: 437-455.

Sumner, P. E. 2005. Equipment Modifications for Migrating from Methyl
Bromide on Vegetables. Misc Pub # ENG05-003. Available at    HYPERLINK
"http://www.tifton.uga.edu/veg/publications.htm"
www.tifton.uga.edu/veg/publications.htm .

Taylor, M. B. Bruton, W. Fish, W. Roberts.  2007.  Cost benefit analyses
of using grafted watermelon transplants for Fusarium wilt disease
control. Acta Horticulturae 782: IV International Symposium on Seed,
Transplant and Stand Establishment of Horticultural Crops; Translating
Seed and Seedling Physiology into Technology.

Verhagen, C., G. Lebbink, and J. Bloem.  1996.  Enhanced biodegradation
of the nematicides 1,3-dichloropropene and methyl isothiocyanate in a
variety of soils. Soil Biol. Biochem. 28:1753–1756.

Webster, T. M., A. S. Csinos, A. W. Johnson, C. C. Dowler, D. R. Sumner,
and R. L. Fery.  2001.  Methyl bromide alternatives in a bell pepper –
squash rotation. Crop Prot. 20 (7): 605 – 614.

 It should be noted that the USG does not request methyl bromide for use
in areas of low to moderate pest pressure.  Only cases where key pests
are present at moderate to high levels require methyl bromide for pest
pressure.

USA CUN13 Soil Peppers Open Field		Page   PAGE  1  of   NUMPAGES  16


[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54296-54297]
[FR Doc No: 2015-22678]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0221]

Formal Dispute Resolution: Appeals Above the Division Level;
Revised Draft Guidance for Industry and Review Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry and review
staff entitled ``Formal Dispute Resolution: Appeals Above the Division
Level.'' This guidance is intended to provide recommendations for
industry and review staff on the procedures in the Center for Drug
Evaluation and Research (CDER) and Center for Biologics Evaluation and
Research (CBER) for resolving scientific and/or medical disputes that
cannot be resolved at the division level. This guidance describes
procedures for formally appealing such disputes to the office or center
level and providing information to assist FDA officials in resolving
the issue(s) presented. This draft guidance revises the draft guidance
of the same name issued March 13, 2013.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
revised draft guidance before it begins work on the final version of
the guidance, submit either electronic or written comments on the draft
guidance by December 8, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002, or Office of Communication, Outreach, and Development,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
    Submit electronic comments on the revised draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Khushboo Sharma, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6468, Silver Spring, MD 20993-0002, 301-
796-0700; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry and review staff entitled ``Formal Dispute Resolution: Appeals
Above the Division Level.'' In the course of the review of applications
for user fee products, a wide variety of scientific and/or medical
issues are discussed that are critical to a sponsor's drug product
development program. Sometimes, a sponsor may disagree with the Agency
on a matter, and a dispute arises. Because these disputes often involve
complex scientific and/or medical matters, it is critical that there be
procedures in place to help ensure open, prompt discussion of such
disputes. The procedures and policies described in this guidance are
intended to promote rapid resolution of scientific and/or medical
disputes between sponsors and CDER or CBER.
    This draft guidance revises the draft guidance of the same name
issued March 13, 2013 (78 FR 15955). Based on the docket comments for
the draft guidance as well as on its own initiative, FDA made the
following changes. The scope of the guidance was expanded to include
formal dispute resolution requests for human drug applications covered
under the Biosimilar User Fee Act of 2012. Additionally, certain areas
were revised to provide more clarity, such as when a matter is and is
not appropriate for a formal dispute resolution request, and
information to include in the supporting background information. Also,
this guidance clarifies that CDER and CBER intend to manage formal
requests for appeals of scientific and/or medical

disputes related to an application for a user fee product under any of
the available regulatory mechanisms (i.e., 21 CFR 10.75, 312.48(c),
314.103(c)), through the formal dispute resolution process.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on formal
dispute resolution requests for appeals above the division level. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This revised draft guidance refers to previously approved
collections of information that are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in this draft
guidance have been approved under OMB control number 0910-0430. This
draft guidance is a revision of an earlier version of the guidance. The
revised version contains no additional information collections;
therefore, it continues to be covered under OMB control number 0910-
0430.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22678 Filed 9-8-15; 8:45 am]
BILLING CODE 4164-01-P


Section 2. Sample Collection Information Section 3. Sample Process Dates, Times, and Temperatures Section 4. Number of Colony Forming Units and Calculations Number of E. coli CFU Section 5. Comments 1Ground water under the direct influence of surface water E. coli 1 E. coli per 100 mL Filter no. Number of fecal coliform CFU 2 mL of sample filtered Analyst initials Fecal coliforms 3 4 RESULTS Long Term 2 Enhanced Surface Water Treatment Rule Source Water Monitoring Method Type: Membrane Filtration Analytical Method Number: SM 9222D/ 9222G ( mFC/ NA MUG)

mFC incubation end Fecal coliforms per 100 mL mFC incubation start NA MUG incubation start NA MUG incubation end Time: Time:

Temperature ( oC): Temperature ( oC): Section 1. Laboratory Identification Information Laboratory name: Laboratory ID:

Sample ID ( optional): Sample collection date:

PWS ID: Sample collection time:

PWS facility ID: Holding time:

Turbidity result ( NTU):

Source water type ( circle one): Flowing stream ( FS) Reservoir/ lake ( RL) 1GWUDI FS 1GWUDI RL Date: Date: Sample collection point ID:

Temperature ( oC): Temperature ( oC): Date: Date:

Time: Time:

Draft June 2003


[Federal Register: May 16, 2007 (Volume 72, Number 94)]
[Notices]
[Page 27555-27557]
[DOCID:fr16my07-67]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Sunshine Act Meeting; Notice

May 10, 2007.
    The following notice of meeting is published pursuant to section
3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C.
552b:

Agency Holding Meeting: Federal Energy Regulatory Commission.

Date and Time: Thursday, May 17, 2007, 10 a.m.

Place: Room 2C, 888 First Street, NE., Washington, DC 20426.

Status: Opens.

Matters To Be Considered: Agenda.

    *Note: Items listed on the agenda may be deleted without further
notice

Contact Person for More Information: Kimberly D. Bose, Secretary,
Telephone<PHONE_NUMBER>.
    For a recorded message listing items struck from or added to the
meeting, call<PHONE_NUMBER>.
    This is a list of matters to be considered by the Commission. It
does not include a listing of all documents relevant to the items on
the agenda. All public documents, however, may be viewed on line at the
Commission's Web site at http://www.ferc.gov using the eLibrary link,

or may be examined in the Commission's Public Reference Room.

------------------------------------------------------------------------
      Item No.                  Docket No.                  Company
------------------------------------------------------------------------
                             Administrative
------------------------------------------------------------------------
A-1................  AD02-1-000.....................  Agency
                                                       Administrative
                                                       Matters.
A-2................  AD02-7-000.....................  Customer Matters,
                                                       Reliability,
                                                       Security and
                                                       Market
                                                       Operations.
A-3................  AD06-3-000.....................  Energy Market
                                                       Update.
------------------------------------------------------------------------
                                Electric
------------------------------------------------------------------------
E-1................  ER07-478-000...................  Midwest
                                                       Independent
                                                       Transmission
                                                       System Operator,
                                                       Inc.
E-2................  OMITTED........................

E-3................  OMITTED........................
E-4................  EL06-94-001....................  Borough of
                                                       Chambersburg, PA
                                                       and Town of Front
                                                       Royal, VA. v. PJM
                                                       Interconnection,
                                                       L.L.C.
E-5................  ER06-1218-000..................  PJM
                     ER06-1218-001..................   Interconnection,
                     ER06-1218-002..................   L.L.C.
                     ER06-1218-003..................
                     ER06-1218-004..................
E-6................  OMITTED........................
E-7................  OMITTED........................
E-8................  RR07-9-000.....................  North American
                     RR07-10-000....................   Electric
                                                       Reliability
                                                       Corporation.
E-9................  ER07-205-000...................  Ameren Energy
                     ER07-205-001...................   Marketing,
                                                       Central Illinois
                                                       Public Service
                                                       Company, Central
                                                       Illinois Light
                                                       Company, Illinois
                                                       Power Company and
                                                       Union Electric
                                                       Company.
E-10                 ER07-648-000...................  California
                                                       Independent
                                                       System Operator
                                                       Corporation
E-11...............  ER07-655-000...................  ISO New England
                                                       Inc.
E-12...............  QM07-2-000.....................  Duke Energy Shared
                                                       Services, Inc.,
                                                       Duke Energy Ohio,
                                                       Inc., Duke Energy
                                                       Indiana, Inc.,
                                                       and Duke Energy
                                                       Kentucky, Inc.
E-13...............  EC07-53-000....................  Boston Generating,
                                                       LLC, Mystic I,
                                                       LLC, Mystic
                                                       Development, LLC,
                                                       Fore River
                                                       Development, LLC
                                                       and EBG Holdings,
                                                       LLC.
E-14...............  ER01-3001-016..................  New York
                     ER03-647-009...................   Independent
                                                       System Operator,
                                                       Inc.
E-15...............  NJ05-1-001.....................  Western Area Power
                                                       Administration
E-16...............  ER07-231-001...................  PJM
                                                       Interconnection,
                                                       L.L.C., New York
                                                       System Operator,
                                                       Inc., and ISO New
                                                       England Inc.
E-17...............  EL03-37-005....................  Town of Norwood,
                                                       Massachusetts v.
                                                       National Grid
                                                       USA, New England
                                                       Electric System,
                                                       Massachusetts
                                                       Electric Company,
                                                       and Narragansett
                                                       Electric Light
                                                       Company.
E-18...............  RM07-11-000....................  Applicability of
                                                       Federal Power Act
                                                       Section 215 to
                                                       Qualifying Small
                                                       Power Production
                                                       and Cogeneration
                                                       Facilities.
E-19...............  OMITTED........................
E-20...............  OMITTED........................
E-21...............  OMITTED........................
E-22...............  OMITTED........................
E-23...............  ER03-563-030...................  Devon Power LLC.
                     ER03-563-060...................
E-24...............  EL06-83-000....................  Southwest Power
                                                       Pool, Inc.
E-25...............  EL00-95-000....................  San Diego Gas &
                                                       Electric Company
                                                       v. Sellers of
                                                       Energy and
                                                       Ancillary
                                                       Services.
                     EL00-98-000....................  Investigation of
                                                       Practices of the
                                                       California
                                                       Independent
                                                       System Operator
                                                       and the
                                                       California Power
                                                       Exchange.
                     EL01-10-000....................  Puget Sound
                                                       Energy, Inc. v.
                                                       Sellers of Energy
                                                       and/or Capacity.
                     EL03-165-000...................  Portland General
                                                       Electric Company.
                     IN03-10-000....................  Investigation of
                                                       Anomalous Bidding
                                                       Behavior and
                                                       Practices in
                                                       Western Markets.
                     PA02-2-000.....................  Fact-Finding
                                                       Investigation
                                                       Into Possible
                                                       Manipulation of
                                                       Electric and
                                                       Natural Gas
                                                       Prices.
E-26...............  ER07-284-000...................  San Diego Gas &
                     ER07-284-001...................   Electric Company
                     ER07-284-002...................
E-27...............  ER05-560-001...................  Midwest
                     ER05-560-002...................   Independent
                                                       Transmission
                                                       System Operator,
                                                       Inc.
E-28...............  EL00-95-000....................  San Diego Gas &
                                                       Electric Company
                                                       v. Sellers of
                                                       Energy and
                                                       Ancillary
                                                       Services.
                     EL00-98-000....................  Investigation of
                                                       Practices of the
                                                       California
                                                       Independent
                                                       System Operator
                                                       and the
                                                       California Power
                                                       Exchange.
                     EL02-113-000...................  El Paso Electric
                                                       Company, Enron
                                                       Power Marketing,
                                                       Inc., and Enron
                                                       Capital and Trade
                                                       Resources
                                                       Corporation.
                     EL02-114-007...................  Portland General
                                                       Electric Company.
                     EL02-115-008...................  Enron Power
                                                       Marketing, Inc.
                     EL03-154-000...................  Enron Power
                     EL03-180-000...................   Marketing, Inc.
                                                       and Enron Energy
                                                       Services, Inc.
                     IN03-10-000....................  Investigation of
                                                       Anomalous Bidding
                                                       Behavior and
                                                       Practices in
                                                       Western Markets.
                     PA02-2-000.....................  Fact-Finding
                                                       Investigation
                                                       Into Possible
                                                       Manipulation of
                                                       Electric and
                                                       Natural Gas
                                                       Prices.
E-29...............  EL04-123-002...................  Entergy Services
                     EL05-105-000...................   Inc.
                     EL05-105-001...................
                     ER91-569-026...................
E-30...............  OMITTED........................
E-31...............  EL06-88-001....................  Dominion Nuclear
                                                       Connecticut, Inc.
                                                       v. Connecticut
                                                       Light and Power
                                                       Company.
E-32...............  ER07-116-000...................  ISO New England
                     ER07-116-001...................   Inc.
E-33...............  ER06-1552-001..................  Midwest
                                                       Independent
                                                       Transmission
                                                       System Operator,
                                                       Inc.
E-34...............  EL07-15-000....................  Ontelaunee Power
                                                       Operating
                                                       Company, LLC v.
                                                       Metropolitan
                                                       Edison Company.
E-35...............  EL06-69-000....................  ALLETE, Inc. (d/b/
                                                       a Minnesota
                                                       Power) v. Midwest
                                                       Independent
                                                       Transmission
                                                       System Operator,
                                                       Inc.
E-36...............  ER06-1552-002..................  Midwest
                                                       Independent
                                                       Transmission
                                                       System Operator,
                                                       Inc.
E-37...............  ER03-765-002...................  Calpine Oneta
                     ER03-765-003...................   Power, L.P.
E-38...............  OMITTED........................
E-39...............  OMITTED........................

E-40...............  EL04-99-000....................  Mississippi Delta
                                                       Energy Agency and
                                                       Clarksdale Public
                                                       Utilities
                                                       Commission v.
                                                       Entergy Services,
                                                       Inc. and Entergy
                                                       Operating
                                                       Companies.
E-41...............  EL07-20-000....................  Leadore Wind Farm
                                                       v. PacifiCorp.
------------------------------------------------------------------------
                                   Gas
------------------------------------------------------------------------
G-1................  PR07-5-000.....................  Cranberry Pipeline
                                                       Corporation.
G-2................  OMITTED........................
------------------------------------------------------------------------
                                  Hydro
------------------------------------------------------------------------
H-1................  P-1893-042.....................  Public Service
                                                       Company of New
                                                       Hampshire.
H-2................  P-1494-310.....................  Grand River Dam
                                                       Authority.
H-3................  P-9042-069.....................  Gallia Hydro
                                                       Partners.
H-4................  EL06-91-001....................  Fourth Branch
                                                       Associates
                                                       (Mechanicville)
                                                       v. Hudson River-
                                                       Black River
                                                       Regulating
                                                       District.
                     P-12252-024....................  Hudson River-Black
                                                       River Regulating
                                                       District.
H-5................  P-12574-001....................  Santiam Water
                                                       Control District.
------------------------------------------------------------------------
                              Certificates
------------------------------------------------------------------------
C-1................  CP07-44-000....................  Southeast Supply
                                                       Header, LLC and
                                                       Southern Natural
                                                       Gas Company.
                     CP07-45-000....................  Southeast Supply
                     CP07-46-000....................   Header, LLC.
                     CP07-47-000....................
C-2................  CP06-85-002....................  CenterPoint Energy
                     CP07-41-000....................   Gas Transmission
                                                       Company.
C-3................  CP07-70-000....................  Southern Natural
                                                       Gas Company.
C-4................  RM06-12-001....................  Regulations for
                                                       Filing
                                                       Applications for
                                                       Permits to Site
                                                       Interstate
                                                       Electric
                                                       Transmission
                                                       Facilities.
C-5................  CP98-150-009...................  Millennium
                                                       Pipeline Company,
                                                       L.L.C.
                     CP02-31-003....................  Iroquois Gas
                                                       Transmission
                                                       System, L.P.
                     CP06-5-004.....................  Empire State
                     CP06-6-003.....................   Pipeline and
                     CP06-7-003.....................   Empire Pipeline,
                                                       Inc.
                     CP06-76-001....................  Algonquin Gas
                                                       Transmission,
                                                       LLC.
------------------------------------------------------------------------

Kimberly D. Bose,
Secretary.
    A free Web cast of this event is available through
http:http://www.ferc.gov. Anyone with Internet access who desires to view this

event can do so by navigating to http://www.ferc.gov Calendar of Events and

locating this event in the Calendar. The event will contain a link to
its Web cast. The Capitol Connection provides technical support for the
free Web casts. It also offers access to this event via television in
the DC area and via phone bridge for a fee. If you have any questions,
visit http://www.CapitolConnection.org or contact Danelle Perkowski or

David Reininger at<PHONE_NUMBER>.
    Immediately following the conclusion of the Commission Meeting, a
press briefing will be held in Commission Meeting Room. Members of the
public may view this briefing in the designated overflow room. This
statement is intended to notify the public that the press briefings
that follow Commission meetings may now be viewed remotely at
Commission headquarters, but will not be telecast through the Capitol
Connection service.

[FR Doc. E7-9458 Filed 5-15-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 170 (Friday, August 31, 2018)]
[Notices]
[Page 44626]
[FR Doc No: 2018-19015]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2018-0578; FRL-9982-38]

Pesticide Product Registration; Receipt of Applications for New
Active Ingredients

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and
opportunity to comment on these applications.

DATES: Comments must be received on or before October 1, 2018.

ADDRESSES: Submit your comments, identified by the Docket
Identification (ID) Number and the File Symbol of interest as shown in
the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Registration Applications

    EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4)
(7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and
opportunity to comment on these applications. Notice of receipt of
these applications does not imply a decision by the Agency on these
applications.

III. New Active Ingredients

    1. File Symbol: 82074-RA. Docket ID number: EPA-HQ-OPP-2016-0079.
Applicant: LAM International Corp., 117 South Parkmont St., Butte, MT
59701. Product name: Biostat 10% WP. Active ingredient: Nematocide--
Purpureocillium lilacinum strain PL11 at 10.0%. Proposed use: The
proposed product is a wettable powder formulation containing spores of
a soil fungus that parasitizes many species of plant-parasitic
nematodes and is to be applied in agricultural settings.
    2. File Symbol: 82074-RL. Docket ID number: EPA-HQ-OPP-2016-0079.
Applicant: LAM International Corp., 117 South Parkmont St., Butte, MT
59701. Product name: Biostat 2% WP. Active ingredient: Nematocide--
Purpureocillium lilacinum strain PL11 at 2.0%. Proposed use: The
proposed product is a wettable powder formulation containing spores of
a soil fungus that parasitizes many species of plant-parasitic
nematodes and is to be applied in agricultural settings.
    3. File Symbol: 82074-RU. Docket ID number: EPA-HQ-OPP-2016-0079.
Applicant: LAM International Corp., 117 South Parkmont St., Butte, MT
59701. Product name: PL11 Technical. Active ingredient: Nematocide--
Purpureocillium lilacinum strain PL11 at 100.0%. Proposed use: For
manufacturing of Purpureocillium lilacinum strain PL11 pesticide
products.

    Authority: 7 U.S.C. 136 et seq.

    Dated: August 14, 2018.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2018-19015 Filed 8-30-18; 8:45 am]
 BILLING CODE 6560-50-P


In vitro Bacterial Gene Mutation (Salmonella typhimurium/ E. coli)/
mammalian activation gene mutation assay	466951109 (2005)

Acceptable/ guideline

0, 33, 100, 333, 1000, 2500, or 5000 (g/plate (+/- S9-activation) in the
E. coli strain ; or 0, 1, 3.33, 10, 33.3, 100, 333, and 1000 (g/plate
(-S9) and 0, 3.33, 10, 33.3, 100, 333, 1000, and 5000 (g/plate (+S9) in
the Salmonella strains	There was no evidence of induced mutant colonies
over background.

(Negative)

870.5300

In Vitro Gene Mutation assay in Chinese Hamster Ovary cells	4669510
(2005)

Acceptable/ guideline

0, 10, 20, 30, 40, 50, 60, 70, 80, 100, 120, 140, 160, 180, 200, 260,
and 320 (g/mL (-S9),

0, 10, 20, 40, 80, 160, 200, 240, 280, and 320 (g/mL (+S9)	There was no
evidence of induced mutant colonies over background in the presence or
absence of S9-activation.

(Negative)

870.5395

In Vivo Mammalian Cytogenetics - Erythrocyte Micronucleus Assay in Mice
46695112 (2005)

Acceptable/guideline

0, 500, 1000, or 2000 mg/kg	No statistically significant increases in
the micronucleated polychromatic erythrocytes (MPCE) frequency or % of
polychromatic erythrocytes (PCE) were observed in any treatment group
when compared to controls.

(Negative)

870.5375

In vitro Mammalian Cytogenetics (Chromosomal Aberration Assay in Rat

Lymphocytes)	46695111 (2005)

Acceptable/guideline

0, 2.5, 5, 10, 20, 30, 40, 50, or 100 µg/mL (-S9),

0, 5, 10, 20, 30, 40, 50, 60, 80, or 100 µg/mL (+S9).	There were no
significant increases in the frequency of aberrant cells (excluding
gaps) noted in the presence or absence of S9 at any exposure period.

(Negative)

870.6200

Subchronic Neurotoxicity screening battery	46995113 (2005)

Acceptable/guideline

0, 200, 630, and 2000 mg/kg

	NOAEL = 2000 mg/kg.

LOAEL was not observed.

870.7485

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etabolism and pharmacokinetics

Rat	46695114 (2005)

Acceptable/ guideline

single p.o. dose 10 or 100 mg/kg

14 daily doses 10 mg/kg

single i.v. dose 10 mg/kg

	The orally administered doses were rapidly absorbed.  The absorbed dose
was 70% or greater.  After 168 h, total recoveries ranged from
88.1-97.1% of the administered doses, with no differences observed
between dose levels, single or multiple doses, or route of exposure.
The majority of the radioactivity was recovered in the feces (77.4-89.6%
of the administered dose), while urine (3.3-9.6%) was a minor route of
elimination. The majority of the radioactivity in the feces was
recovered during the first 24 h, while the majority of radioactivity
recovered in the urine was recovered during the first 12 h.  Animals
given an i.v. dose of the test compound eliminated a larger proportion
of radioactivity in the urine (9.0-9.6% vs 3.3-4.7%), and elimination of
radioactivity in the feces was prolonged compared to orally-dosed
animals.  However the total amount of radioactivity excreted in the
feces was similar regardless of route of administration, suggesting that
a large percentage of orally-administered XDE-175-J would be eliminated
in the feces via biliary excretion.  The carcass contained the highest
levels of radioactivity (0.2-1.3% administered dose); no other tissue
exceeded 0.4% of the administered dose.  The highest concentrations of
radioactivity were generally detected in fat, kidneys, liver, and lymph
nodes, and in the ovaries in females.  There was no evidence of
bioaccumulation.  The test compound was extensively metabolized
regardless of the route of administration.  The majority of
radioactivity recovered from urine and fecal extract samples was present
as parent and a total of seven metabolites, the largest proportion of
which were found in the fecal extracts. Metabolic profiles were
qualitatively similar for all of the experimental groups. The major
route of metabolism was found to be glutathione conjugation with the
parent compound, as well as glutathione conjugation with N-demethylated,
O-deethylated, and hydroxylated forms of the parent compound.  Parent
and identified compounds accounted for 70.9-83.4% of the administered
dose, while unidentified metabolites accounted for 9.6-17.1% of the
administered dose.  The total administered dose accounted for in the
excreta was 86.4-94.7%. Parent compound accounted for 7.0-22.2% (40.0%
in the 100 mg/kg males) of the total radioactivity eliminated, and was
found almost exclusively in the fecal extracts.  The majority of
radioactivity (31.4-61.0% of the administered dose) was identified as
the glutathione conjugate of D5-XDE-175-J, the glutathione conjugate of
XDE-175-J, and the glutathione conjugate of N-demethyl-XDE-175-J in the
urine, and the glutathione conjugate of XDE-175-J and the cysteine
conjugate of XDE-175-J (tentatively identified) in the feces.  The other
major identified metabolites were identified as the glutathione
conjugate of 3’-O-deethyl-XDE-175-J and the glutathione conjugate of
hydroxy-XDE-175-J (tentatively identified) in the urine, and the
cysteine conjugate of 3’-O-deethyl-XDE-175-J (tentatively identified)
and the cysteine conjugate of hydroxyl-XDE-175-J (tentatively
identified) in the feces (2.3-20.0% total).  An additional major
metabolite was identified as 3’-O-deethyl-XDE-175-J (3.9-14.4%) and
was found almost exclusively in the feces. In animals dosed with
[14C]N-formyl-XDE-175-J (the plant metabolite), the majority of
radioactivity was recovered in the feces (89-2-91.7%), while urine
(3.4-4.4%) was a minor route of elimination.  The radioactivity was
rapidly excreted during the first 24 h, similar to the other groups.  It
was stated that the N-formyl plant metabolite was also highly
metabolized, and that the major metabolites were tentatively identified
as the parent N-formyl test material and cysteine conjugates of the
N-formyl parent and N-demethyl-XDE-175-J.  Based on the fecal metabolite
profile, it was estimated that 21-28% of this test material was
converted to metabolites that may be common with those formed from the
parent compound.

Parent compound accounted for 7.0-22.2% (40.0% in the 100 mg/kg males)
of the total radioactivity eliminated, and was found almost exclusively
in the fecal extracts.  The majority of radioactivity (31.4-61.0% of the
administered dose) was identified as the glutathione conjugate of
D5-XDE-175-J, the glutathione conjugate of XDE-175-J, and the
glutathione conjugate of N-demethyl-XDE-175-J in the urine, and the
glutathione conjugate of XDE-175-J and the cysteine conjugate of
XDE-175-J (tentatively identified) in the feces.  The other major
identified metabolites were identified as the glutathione conjugate of
3’-O-deethyl-XDE-175-J and the glutathione conjugate of
hydroxy-XDE-175-J (tentatively identified) in the urine, and the
cysteine conjugate of 3’-O-deethyl-XDE-175-J (tentatively identified)
and the cysteine conjugate of hydroxyl-XDE-175-J (tentatively
identified) in the feces (2.3-20.0% total).  An additional major
metabolite was identified as 3’-O-deethyl-XDE-175-J (3.9-14.4%) and
was found almost exclusively in the feces.

In animals dosed with [14C]N-formyl-XDE-175-J (the plant metabolite),
the majority of radioactivity was recovered in the feces (89-2-91.7%),
while urine (3.4-4.4%) was a minor route of elimination.  The
radioactivity was rapidly excreted during the first 24 h, similar to the
other groups.  It was stated that the N-formyl plant metabolite was also
highly metabolized, and that the major metabolites were tentatively
identified as the parent N-formyl test material and cysteine conjugates
of the N-formyl parent and N-demethyl-XDE-175-J.  Based on the fecal
metabolite profile, it was estimated that 21-28% of this test material
was converted to metabolites that may be common with those formed from
the parent compound.

870.7485

Metabolism and pharmacokinetics

Rat	46695115 (2005)

Acceptable/ guideline

single p.o. dose 10 or 100 mg/kg

14 daily doses 10 mg/kg

single i.v. dose 10 mg/kg

	The orally administered doses were rapidly absorbed, as radioactivity
was detected in the plasma at 15 minutes post-dosing.  The calculated
systemic oral bioavailable absorbed dose was 39-57% for the low dose and
73-92% for the high dose.  However, the percent of the administered dose
recovered as metabolite(s) in the urine and feces was much higher at
both doses.  Therefore, it was considered likely that the fraction of
the orally administered dose absorbed was 70% or greater in both the low
and high oral dose groups.  After 168 h, total recoveries ranged from
90.4-94.9% of the administered doses, with no differences observed
between dose levels, single or multiple doses, or route of exposure.
The majority of the radioactivity was recovered in the feces (78.5-86.7%
of the administered dose), while urine (2.3-3.8%) was a minor route of
elimination. The majority of the radioactivity in the feces was
recovered during the first 24 h, while the majority of radioactivity
recovered in the urine was recovered during the first 12 h. Generally,
tissues, carcass, and cage wash accounted for <8%, except for the
i.v.-dosed females (13%). At 168 h, the carcass (1.3-5.8% of the
administered dose) and skin (0.4-5.9%) contained the highest mean levels
of radioactivity; no other tissue (excluding the gastrointestinal tract)
exceeded 0.6% of the administered dose.  In general, the highest
concentrations of radioactivity were detected in fat, lymph nodes, skin,
and adrenals in the males, and in the fat, ovaries, lymph nodes, uterus,
skin, and adrenals in females.  Radioactivity was detected at low levels
in other tissues.  Radioactivity did not partition into the RBC.  Time
courses of radioactivity distribution in tissues was not performed;
however, relatively little radioactivity remained in the tissues or
carcass at 168 h post-dosing.  Therefore, there was no evidence of
bioaccumulation. The test compound was extensively metabolized
regardless of the route of administration.  The majority of
radioactivity in urine and fecal extract samples was present as parent
and a total of nine metabolites.  Metabolic profiles were qualitatively
similar across dose levels and route of exposure, and no major
differences were noted between sexes.  The major route of metabolism was
found to be glutathione conjugation with the parent compound, as well as
glutathione conjugation with N-demethylated and O-deethylated forms of
the parent compound.  In excreta, parent and identified compounds
accounted for 70.7-85.8% of the administered dose, while unidentified
metabolites accounted for 0.8-16.1% of the administered dose.  The total
administered dose accounted for in the excreta was 82.0-89.1%.  Parent
compound accounted for 6.5-26.1% of the total radioactivity eliminated,
and was found almost exclusively in the fecal extracts.  The majority of
the radioactivity was contained in Peak 5 (50.7-66.4% of the
administered dose), which consisted of the glutathione conjugate of
D5-XDE-175-L, the glutathione conjugate of XDE-175-L and the glutathione
conjugate of N-demethyl-XDE-175-L in the urine, and the cysteine
conjugate of XDE-175-L (tentatively identified) in the feces.  Peak 9
(3.9-7.7%) was identified as N-demethyl-XDE-175-L and was found in the
feces.  The only other identified metabolite was contained in Peak 3
(0.1-1.2%), and was tentatively identified as the cysteine conjugate of
3’-O-deethyl-XDE-175-L.

Spinosad and Spinetoram 	Human Health Risk Assessment	D357837, D357855

Page   PAGE  2  of   NUMPAGES  54