SEQ CHAPTER \h \r 1 6.3 Residential (Non-Occupational) Exposure/Risk
Pathway  tc "6.3	Residential (Non-Occupational) Exposure/Risk Pathway "
\l 2

6.3.1 Residential Handler Noncancer Postapplication Exposures and Risks

Rotenone is currently registered for use in a variety of residential
scenarios, however, the rotenone technical registrants (Foreign Domestic
Chemicals Corporation (3/17/06); Prentiss, Inc. (3/7/06); and Tifa
Limited (4/5/06) voluntarily cancelled all uses of rotenone except for
the piscicidal uses.  The cancelled uses of rotenone were previously
assessed in the January 24, 2006 risk assessment (DP barcode D307385),
which can be found on EPA’s website.  SEQ CHAPTER \h \r 1

6.3.2 Residential (Recreational) Postapplication Noncancer
Postapplication Exposures and Risks

HED uses the term “postapplication” to describe exposures to
individuals that occur as a result of being in an environment that has
been previously treated with a pesticide.  Rotenone can be used in
various types of water bodies that can be frequented by the general
public.  As a result, individuals can be exposed by swimming in the
rotenone treated water.

The Standard Operating Procedures (R-SOPs) For Residential Exposure
Assessment define several scenarios that apply to uses specified on
current rotenone labels.  These scenarios served as the basis for the
residential postapplication assessment.  The assumptions and factors
used in the risk calculations are consistent with current Agency policy
for completing residential exposure assessments (i.e., R-SOPs) and can
be found in detail in section 3.2.2 of Rotenone: Phase 5 Occupational
and Residential Exposure Assessment for the Reregistration Eligibility
Decision Document.  Charles W. Smith.  May 30, 2006.

Adults: For all adult postapplication scenarios, short-term risks for
swimming do not exceed HED’s level of concern (i.e., the MOEs are
greater than 1000) on the day of application.  Table 6.3.2a presents the
postapplication MOEs for adults following applications of rotenone.

Table 6.3.2a: Adult Residential (Recreational) Risk Estimates for
Postapplication Exposure to Rotenone

Exposure Scenario	Route of Exposure	Application Rate	MOE at Day 0

Swimming - Dermal	Dermal	0.25 ppm	1,300

0.20 ppm	1,600

Swimming – Incidental Ingestion	Oral	0.25 ppm	5,600

0.20 ppm	7,000

  SEQ CHAPTER \h \r 1 Toddler (3 year old): For all toddler
postapplication scenarios, short-term risks for swimming exceed HED’s
level of concern (i.e., the MOEs are less than 1000) on the day of
application.    Table 6.3.2b presents a summary of the MOE estimates for
toddlers.

Table 6.3.2b: Toddler Residential (Recreational)  Risk Estimates for
Postapplication Exposure to Rotenone

Exposure Scenario	Route of Exposure	Application Rate	MOE at Day 0

Swimming - Dermal	Dermal	0.25 ppm	770

0.20 ppm	970

Swimming – Incidental Ingestion	Oral	0.25 ppm	680

0.20 ppm	850

The Environmental Fate and Effects Division (EFED) calculated the number
of days it would take to reach a rotenone concentration that results in
acceptable toddler MOEs (170 ppb of rotenone results in an oral MOE of
1000 and a dermal MOE of 1100).   This is done by assuming that the
dissipation rate for rotenone in a warm water pond is 1.5 days, as seen
in the aquatic dissipation study.  The time it takes for the rotenone to
dissipate (in 25oC water) to 170 ppb from 200 ppb is 0.35 days and from
250 ppb is 0.89 days.  EFED assumed first order degradation below 200
ppb and zero order degradation above.  Zero order degradation assumes
that the degradation rate is constant with time.  This includes the
assumption that more rotenone dissolves to keep the concentration
constant at 200 ppb until all the rotenone is in solution, and then
first order kinetics occurs after that.  The temperature in the “warm
water” pond in the aquatic dissipation study was 25oC which EFED and
HED consider to be a temperature at which swimming by the general public
could reasonably occur.

Combined Risk Assessment for Residential (Recreational) Scenarios

HED combines risk values resulting from separate postapplication
exposure scenarios when it is likely they can occur simultaneously based
on the use-pattern and the behavior associated with the exposed
population.  Table 6.3.2c presents a summary of the combined MOE
estimates.

Table 6.3.2c: Rotenone Residential (Recreational) Scenarios for Combined
Risk Estimates

Postapplication Exposure Scenario	Margins of Exposure (MOEs)

(UF=1000)

	Short-Term Oral

(Non-Dietary)	Total  Non-Dietary Risk

Toddler	Swimming (0.25 ppm)	Dermal	770	360

Incidental Ingestion	680

Swimming (0.20 ppm)	Dermal	970	450

Incidental Ingestion	850

HED calculated the number of days it would take to reach a rotenone
concentration that results in acceptable toddler combined MOEs (90 ppb
of rotenone results in an oral MOE of 1900 and a dermal MOE of 2100,
which results in a combined MOE of 1000).  The time it takes for the
rotenone to dissipate to 90 ppb from 200 ppb is approximately 2 days and
from 250 ppb is approximately 3 days.  HED believes that swimming in
rotenone treated waters should be prohibited for at least 2 days after
completion of a 200 ppb rotenone application and at least 3 days after
completion of a 250 ppb rotenone application.

In residential settings, HED does not use restricted-entry intervals or
other mitigation approaches to limit postapplication exposures, because
they are viewed as impractical and not enforceable.  As such, risk
estimates on the day of application are the key concern.  However, in
the case of rotenone, HED believes that swimming in rotenone treated
waters should be prohibited for at least 2 days after completion of a
200 ppb rotenone application and at least 3 days after completion of a
250 ppb rotenone application.

6.3.3 Spray Drift  tc "<IP_ADDRESS> Spray Drift " \l 4

Spray drift is always a potential source of exposure to residents nearby
to spraying operations.  This is particularly the case with aerial
application.  The Agency has been working with the Spray Drift Task
Force, EPA Regional Offices and State Lead Agencies for pesticide
regulation and other parties to develop the best spray drift management
practices.  The Agency is now requiring interim mitigation measures for
aerial applications that must be placed on product labels/labeling.  The
Agency has completed its evaluation of the new data base submitted by
the Spray Drift Task Force, a membership of the U.S. pesticide
registrants, and is developing a policy on how to appropriately apply
the data and the AgDRIFT computer model to its risk assessments for
pesticides applied by air, orchard airblast, and ground hydraulic
methods.  After the policy is in place, the Agency may impose further
refinements in spray drift management practices to reduce off-target
drift and risks associated with aerial, as well as other application
types, where appropriate.

7.0 Aggregate Risk Assessments and Risk Characterization

In accordance with the Food Quality Protection Act (FQPA) of 1996, for
chemicals having tolerances in food, HED must consider and aggregate
pesticide exposures and risks from three major sources: food, drinking
water, and residential exposures (oral, dermal, and inhalation).   All
uses of rotenone on food crops have been proposed to be cancelled and
thus the requirements of FQPA are not applicable and aggregate risk
assessments have not been conducted.  SEQ CHAPTER \h \r 1

8.0 Cumulative Risk Characterization/Assessment

  SEQ CHAPTER \h \r 1 FQPA stipulates that when determining the safety
of a pesticide chemical, EPA shall base its assessment of the risk posed
by the chemical on, among other things, available information concerning
the cumulative effects to human health that may result from dietary,
residential, or other non-occupational exposure to other substances that
have a common mechanism of toxicity.  All uses of rotenone on food crops
have been proposed to be cancelled and thus the requirements of FQPA are
not applicable and a cumulative risk assessment has not been conducted.
SEQ CHAPTER \h \r 1

9.0 Occupational Exposure/Risk Pathway

Rotenone is currently registered for use in a variety of residential
scenarios, however, the rotenone technical registrants (Foreign Domestic
Chemicals Corporation (3/17/06); Prentiss, Inc. (3/7/06); and Tifa
Limited (4/5/06) voluntarily cancelled all uses of rotenone except for
the piscicidal uses.  This assessment deals with occupational
populations that could be potentially exposed while performing rotenone
piscicide applications.  Occupational risks associated with the
cancelled uses of rotenone were previously assessed in the January 24,
2006 risk assessment (DP barcode D307385), which can be found on EPA’s
website.

	  SEQ CHAPTER \h \r 1 9.1 Short/Intermediate-term Noncancer Handler
Exposure and Risk

  SEQ CHAPTER \h \r 1 Exposure scenarios categorize the exposures that
occur during the use of a chemical.  The commonly used scenarios in
exposure assessments are described in the U.S. EPA Guidelines for
Exposure Assessment (U.S. EPA; Federal Register Volume 57, Number 104;
May 29, 1992).  Information from the current labels, use and usage
information, toxicology data, and exposure data were all key components
in developing the exposure scenarios.  For exposure and risk assessment
purposes, tasks of pesticide handlers associated with occupational
pesticide use are categorized as one of the following:

Mixers and/or Loaders:  these individuals perform tasks in preparation
for an application.  For example, prior to application, mixer/loaders
would mix the rotenone and load it into the holding tank of the
helicopter or boat.

Applicators: these individuals operate application equipment during the
release of a pesticide product into the environment.  These individuals
can make applications using equipment such as helicopters or boat-boom
sprayers.

Mixer/Loader/Applicators and or Loader/Applicators: these individuals
are involved in the entire pesticide application process (i.e., they do
all job functions related to a pesticide application event).  These
individuals would transfer rotenone into the application equipment and
then also apply it.

It is important to understand how exposures to rotenone occur (i.e.,
frequency and duration) and how the patterns of these occurrences can
cause the effects of the chemical to differ (referred to as dose
response).  Wherever possible, use and usage data determine the
appropriateness of certain types of risk assessments.  Other parameters
are also defined from use and usage data such as application rates and
application frequency.  HED always completes non-cancer risk assessments
using maximum application rates for each scenario because what is
possible under the label (the legal means of controlling pesticide use)
must be evaluated in order to ensure there are no concerns for each
specific use.

The frequency and duration of pesticide handlers’ exposures must also
be estimated in order to determine which toxicological endpoints are
applicable to a handler exposure scenario.  HED believes that
occupational rotenone exposures may occur over a few days for many
use-patterns and that intermittent exposure over several weeks also may
occur.  Custom or commercial applicators may apply rotenone over a
period of weeks, completing applications for a number of different
clients.  HED classifies exposures up to 30 days as short-term and
exposures greater than 30 days up to several months as
intermediate-term.  HED completes both short- and intermediate-term
assessments for occupational scenarios in essentially all cases, because
these kinds of exposures are likely, and often reliable use/usage data
are not available to justify deleting intermediate-term scenarios.
Long-term handler exposures are not expected to occur for rotenone.  The
same toxicological endpoint (0.5 mg/kg/day from an oral study) of
concern was selected for short- and intermediate-term dermal exposures
to rotenone, therefore the risk results for all dermal durations of
exposure are numerically identical.  The HazSPoC report, dated June 28,
2005, states that a dermal absorption factor of 10% should be used to
assess dermal risks, since the dermal endpoint for rotenone is from an
oral study.  The same toxicological endpoint (0.5 mg/kg/day from an oral
study) has been selected for short- and intermediate-term inhalation
exposures to rotenone, therefore the risk results for all inhalation
durations of exposure are numerically identical.  A default inhalation
absorption factor of 100% was used to assess inhalation risks, since the
inhalation endpoint for rotenone is from an oral study.

Occupational handler exposure assessments are completed by HED using
different levels of personal protection.  HED typically evaluates all
exposures with a tiered approach.  The lowest tier is represented by the
baseline exposure scenario (i.e., long-sleeve shirt, long pants, shoes,
socks, and no respirator) followed by increasing the levels of personal
protective equipment or PPE (e.g., gloves, double-layer body protection,
and respirators), and then by engineering controls (e.g., enclosed cabs
and closed mixing/loading systems).  This approach is always used by HED
in order to be able to define label language using a risk-based
approach.  In addition, the minimal level of adequate protection for a
chemical is generally considered by HED to be the most practical option
for risk reduction (i.e., over-burdensome risk mitigation measures are
not considered a practical alternative).

9.1.1 Short/Intermediate-Term Handler Risks tc "9.1
Short/Intermediate/Long-Term Handler Exposure and Risk " \l 2

The anticipated use patterns and current labeling indicate several
likely occupational handler exposure scenarios, based on the types of
equipment and techniques that can potentially be used to apply rotenone
to aquatic use sites.  Anticipated use pattern and current labeling
indicate 12 likely occupational exposure scenarios.  Scenarios in this
document include:

Mixer/Loaders:

	(1a) Liquid Formulations for Helicopter Applications

(1b) Liquid Formulations for Boat Applications (boom and underwater
weighted hose applications)

	(2a) Wettable Powder Formulations for Boat Applications (boom and
underwater weighted hose applications)

	Applicators:

(3) Helicopter Spray Applications (using PHED fixed wing aerial spray
application data)

(4) Boat Boom Spray Applications (using PHED groundboom spray
application data)

	Mixer/Loader/Applicators:

(5) Liquid Formulations: Backpack Sprayer (using PHED liquid low
pressure handwand data)

(6)  Liquid Formulations: Closed System Aspirators (using PHED closed
system mixing/loading liquids) – no contact should occur once liquid
rotenone is loaded

(7)  Liquid Formulations: Drip Bars (using PHED mixing/loading liquids)
– no contact should occur once liquid rotenone is loaded

(8) Wettable Powder: Backpack Sprayer (using PHED wettable powder low
pressure handwand data)

(9)  Wettable Powder Formulations: Closed System Aspirators (using PHED
closed system mixing/loading wettable powders) - no contact should occur
once wettable powder rotenone is loaded

(10)  Wettable Powder Formulations: Drip Bars (using PHED mixing/loading
wettable powders) - no contact should occur once wettable powder
rotenone is loaded

(11)  Wettable Powder Formulations: Powder/Sand/Gelatin Pastes

The following assumptions and factors were used in order to complete
this exposure assessment:

Average body weight of an adult handler is 70 kg.  This body weight is
used in the short- and intermediate-term assessments, since the endpoint
of concern is not gender-specific.

The number of acres treated or volume of spray solution applied per day
are specific to each equipment type addressed in the exposure assessment
and are representative of the amount that can be treated/applied in a
single 8 hour workday for each exposure scenario.

  SEQ CHAPTER \h \r 1 Various exposure factors used in the calculations
(e.g., acres treated or gallons handled per day for each application
method) are based on the best professional judgment of EPA due to a lack
of extensive pertinent data.

Daily areas and volumes (as appropriate) to be treated in each
occupational exposure scenario include: 5 to 10 acres with a water body
depth of 5 feet for aerial applications to stationary water bodies; 2
acres with a water body depth of 5 feet for backpack sprayer
applications to stationary water bodies; 211200 ft3 (10560 feet long
with a water body depth of 2 feet and a water body width of 10 feet) for
backpack sprayer and drip bar applications to moving water bodies (i.e.,
streams, rivers, etc.); and 50 to 100 acres with a water body depth of 5
feet for closed system aspirator, boat-boom, and boat-weighted hose
applications to stationary water bodies (personal contact with Brian
Finlayson, California Department of Fish and Game on 1/9/06).

Occupational handler exposure estimates were based on surrogate data
from the Pesticide Handlers Exposure Database (PHED) as no chemical or
application equipment specific exposure data were available.  PHED
consists of data that were produced for the purposes of assessing
land-based agricultural and residential application scenarios.  In the
case of rotenone, applications occur over and to water bodies.  There
are clearly limitations and uncertainties regarding the use of PHED to
assess rotenone occupational handler exposure because of the distinct
differences in application sites (land vs. water), however, HED can not
currently define the extent of these limitations and uncertainties.
Specific examples of surrogate scenarios used in this assessment are
explained below:

To assess exposure from applying sprays via helicopter, the exposure
scenario for applying via fixed wing aircraft was used.

To assess exposure from applying sprays via boat-mounted spray
equipment, the exposure scenario for applying via ground boom equipment
was used.

To assess exposure from mixing/loading/applying liquid formulations via
closed system aspirators, the exposure scenario for liquid formulation
closed system mixing/loading equipment was used.

To assess exposure from mixing/loading/applying wettable powder
formulations via closed system aspirators, the exposure scenario for
wettable powder formulation closed system mixing/loading equipment was
used.

To assess exposure from mixing/loading/applying liquid formulations via
drip bars (in moving waters), the exposure scenario for liquid
formulation mixing/loading equipment was used.

To assess exposure from mixing/loading/applying wettable powder
formulations via drip bars (in moving waters), the exposure scenario for
wettable powder formulation mixing/loading equipment was used.

Due to a lack of scenario-specific data, EPA sometimes calculates unit
exposure values using generic protection factors that are applied to
represent various risk mitigation options (i.e., the use of PPE and
engineering controls).  PPE protection factors include those
representing double layers of clothing (50%) and respiratory protection
(90%).  Engineering controls are generally assigned a protection factor
of 90% or higher.  Engineering controls may include closed
mixing/loading systems and enclosed cabs and enclosed cockpits.

  SEQ CHAPTER \h \r 1 The noncancer occupational handler exposure and
risk calculations are included in Table 9.1.1 (see Appendix A Tables A2
& A3 in Smith 2006 for complete aquatic handler exposure and risk
calculations).  The results indicate that many of the occupational
aquatic-use handler risks are of concern [i.e., MOEs < LOC of 1000].

Table 9.1.1.  Combined Dermal plus Inhalation Aquatic-Use Occupational
Handler Risks

Exposure Scenario	Crop or Target	Application  Ratea	Area Treated Dailyb
Depth of Water Bodyb	Width of Water Bodyb	Combined MOEsc

Baseline	G + NR	G, DL + NR	G + 80% R	G, DL + 80% R	G + 90% R	G, DL + 90%
R	Eng Cont

Mixer/Loader

Mixing/Loading Liquid Concentrates for Helicopter Applications (1a)
Lakes, ponds	0.68 lb ai/A-ft	10 acres	5 ft	NA	3.5	290	350	410	530	430
570	1100

	Lakes, ponds	0.68 lb ai/A-ft	5 acres	5 ft	NA	7.1	590	710	810	1100	850
1100	2200

	Lakes, ponds	0.54 lb ai/A-ft	10 acres	5 ft	NA	4.5	370	450	510	670	540
710	1400

	Lakes, ponds	0.54 lb ai/A-ft	5 acres	5 ft	NA	8.9	740	890	1000	1300	1100
1400	2700

Mixing/Loading Liquid Concentrates for Boat Applications (1b)	Lakes,
ponds	0.68 lb ai/A-ft	100 acres	5 ft	NA	0.35	29	35	41	53	43	57	110

	Lakes, ponds	0.68 lb ai/A-ft	50 acres	5 ft	NA	0.71	59	71	81	110	85	110
220

	Lakes, ponds	0.54 lb ai/A-ft	100 acres	5 ft	NA	0.45	37	45	51	67	54	71
140

	Lakes, ponds	0.54 lb ai/A-ft	50 acres	5 ft	NA	0.89	74	89	100	130	110
140	270

Mixing/Loading Wettable Powders for Boat Applications (2a)	Lakes, ponds
0.68 lb ai/A-ft	100 acres	5 ft	NA	0.25	1.7	1.8	4	4.8	4.8	6	84

	Lakes, ponds	0.68 lb ai/A-ft	50 acres	5 ft	NA	0.5	3.4	3.7	8	9.5	9.7	12
170

	Lakes, ponds	0.54 lb ai/A-ft	100 acres	5 ft	NA	0.31	2.2	2.3	5.1	6	6.1
7.5	110

	Lakes, ponds	0.54 lb ai/A-ft	50 acres	5 ft	NA	0.63	4.3	4.6	10	12	12	15
210

Applicator

Applying Sprays via Helicopter (3)	Lakes, ponds	0.68 lb ai/A-ft	10 acres
5 ft	NA	ND	ND	ND	ND	ND	ND	ND	1800

	Lakes, ponds	0.68 lb ai/A-ft	5 acres	5 ft	NA	ND	ND	ND	ND	ND	ND	ND	3600

	Lakes, ponds	0.54 lb ai/A-ft	10 acres	5 ft	NA	ND	ND	ND	ND	ND	ND	ND	2300

	Lakes, ponds	0.54 lb ai/A-ft	5 acres	5 ft	NA	ND	ND	ND	ND	ND	ND	ND	4600

Applying Sprays via Boat Over-surface Boom Equipment (4)	Lakes, ponds
0.68 lb ai/A-ft	100 acres	5 ft	NA	48	48	56	66	82	70	88	190

	Lakes, ponds	0.68 lb ai/A-ft	50 acres	5 ft	NA	96	96	110	130	160	140	180
380

	Lakes, ponds	0.54 lb ai/A-ft	100 acres	5 ft	NA	61	61	70	84	100	88	110
240

	Lakes, ponds	0.54 lb ai/A-ft	50 acres	5 ft	NA	120	120	140	170	210	180
220	480

Mixer/Loader/Applicator

Mixing/Loading/Applying Liquids with a Backpack Sprayer (using PHED
liquid low pressure handwand data) (5)	Lakes, ponds	0.68 lb ai/A-ft	2
acres	5 ft	NA	0.51	71	77	110	120	110	130	NF

	Lakes, ponds	0.54 lb ai/A-ft	2 acres	5 ft	NA	0.51	71	77	110	120	110	130
NF

	Moving water (streams)	0.000016 lb ai/ft3	10,560 ft long	2 ft	10 ft	10
1400	1500	2100	2400	2300	2600	NF

	Moving water (streams)	0.000013 lb ai/ft3	10,560 ft long	2 ft	10 ft	13
1700	1900	2600	3000	2800	3200	NF

Mixing/Loading/

Applying Liquids with Closed System Aspirators (PHED: mixing/loading
liquid - closed system) (6)	Lakes, ponds	0.68 lb ai/A-ft	10 acres	5 ft
N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	110

	Lakes, ponds	0.68 lb ai/A-ft	5 acres	5 ft	N/A	N/A	N/A	N/A	N/A	N/A	N/A
N/A	220

	Lakes, ponds	0.54 lb ai/A-ft	10 acres	5 ft	N/A	N/A	N/A	N/A	N/A	N/A	N/A
N/A	140

	Lakes, ponds	0.54 lb ai/A-ft	5 acres	5 ft	N/A	N/A	N/A	N/A	N/A	N/A	N/A
N/A	270

Mixing/Loading/

Applying Liquids with Drip Bars (PHED: mixing/loading liquid) (7)	Moving
water (streams)	0.000016 lb ai/ft3	10,560 ft long	2 ft	10 ft	360	30000
36000	41000	53000	43000	57000	110000

	Moving water (streams)	0.000013 lb ai/ft3	10,560 ft long	2 ft	10 ft	440
36000	44000	50000	66000	53000	70000	140000

Mixing/Loading/

Applying Wettable Powders with a Backpack Sprayer (using PHED wettable
powder low pressure handwand data) (8)	Lakes, ponds 	0.68 lb ai/A-ft	2
acres	5 ft	NA	ND	2.6	3	4.8	6.1	5.3	7.1	NF

	Lakes, ponds	0.54 lb ai/A-ft	2 acres	5 ft	NA	ND	2.6	3	4.8	6.1	5.3	7.1
NF

	Moving water (streams)	0.000016 lb ai/ft3	10,560 ft long	2 ft	10 ft	ND
53	60	96	120	110	140	NF

	Moving water (streams)	0.000013 lb ai/ft3	10,560 ft long	2 ft	10 ft	ND
65	74	120	150	130	170	NF

Mixing/Loading/

Applying Wettable Powders with Closed System Aspirators (PHED:
mixing/loading liquid - closed system) (9)	Lakes, ponds	0.68 lb ai/A-ft
10 acres	5 ft	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	84

	Lakes, ponds	0.68 lb ai/A-ft	5 acres	5 ft	N/A	N/A	N/A	N/A	N/A	N/A	N/A
N/A	170

	Lakes, ponds	0.54 lb ai/A-ft	10 acres	5 ft	N/A	N/A	N/A	N/A	N/A	N/A	N/A
N/A	110

	Lakes, ponds	0.54 lb ai/A-ft	5 acres	5 ft	N/A	N/A	N/A	N/A	N/A	N/A	N/A
N/A	210

Mixing/Loading/

Applying Wettable Powders with Drip Bars (PHED: mixing/loading liquid)
(10)	Moving water (streams)	0.000016 lb ai/ft3	10,560 ft long	2 ft	10 ft
250	1700	1800	4000	4800	4900	6000	85000

	Moving water (streams)	0.000013 lb ai/ft3	10,560 ft long	2 ft	10 ft	310
2100	2300	5000	5900	6000	7400	100000

Mixing/Loading/

Applying Wettable Powders via Powder/Sand/Gelatin Paste (11)	Seeps and
Springs

	N/A	N/A	There is currently no data to assess this scenario.  HED
believes this scenario will result in minimal exposure due to the amount
of rotenone used and the fact that this paste is typically mixed in
either a lab under a fume hood or by an individual wearing a respirator.

a	Application rates are the maximum application rates determined from
EPA registered labels for rotenone

b	Area treated per day values for all application methods except boats
are based on personal contact with Brian Finlayson, California
Department of Fish and Game (1/9/06).  Area treated per day values for
boat application methods are based on HED professional judgement.

c	Baseline:  	Long-sleeve shirt, long pants, no gloves, and no
respirator.

	PPE-G-NR:  	Baseline plus chemical-resistant gloves, and no respirator.

	PPE-G,DL-NR: 	Coveralls worn over long-sleeve shirt and long pants,
chemical-resistant gloves, and no respirator.

	PPE-G-80% R:	Baseline plus chemical-resistant gloves and an 80% PF
(quarter-face dust/mist) respirator.

	PPE-G,DL-80% R: 	Coveralls worn over long-sleeve shirt and long pants,
chemical-resistant gloves, and an 80% PF (quarter-face dust/mist)
respirator.

	PPE-G-90% R:	Baseline plus chemical-resistant gloves and a 90% PF
(half-face dust/mist) respirator.

	PPE-G,DL-90% R: 	Coveralls worn over long-sleeve shirt and long pants,
chemical-resistant gloves, and a 90% PF (half-face dust/mist)
respirator.

	Eng Controls: 	Closed mixing/loading system, enclosed cab, or enclosed
cockpit.

	9.2   SEQ CHAPTER \h \r 1 Short- and Intermediate-term Noncancer
Postapplication Risk

HED expects minimal occupational postapplication exposure from the
pisicidal use of rotenone.  As a result, no quantitative assessment was
completed for occupational postapplication exposure.

10.0 Data Needs and Label Requirements

	10.1 Toxicology

The registrants are no longer supporting agricultural, occupational, or
residential uses, where the greatest potential for inhalation, dietary,
and dermal exposure could occur.  Therefore, the inhalation
neurotoxicity study and all other toxicity data requirements discussed
below will currently be held in reserve (may be called in later).

Guideline metabolism study

21-Day neurotoxicity study in Lewis rats by the inhalation route

Dermal absorption/penetration study

Repeated-dose dermal toxicity study, pending the results of the dermal
absorption/penetration study

Developmental toxicity study in the rabbit

Developmental neurotoxicity (DNT) study by the oral route in the Lewis
rat, pending the results of the subchronic neurotoxicity study by the
inhalation route

Subchronic oral neurotoxicity study in the Lewis rat, pending the
results of the subchronic neurotoxicity study by the inhalation route

For further details, see Table A1. Toxicology Data Requirements for
Rotenone in Appendix A.

	10.2 Residue Chemistry

The following is a list of deficiencies and data gaps that are no longer
required as long as there are no food uses for rotenone:

Guideline requirements regarding plant and animal metabolism remain
outstanding.

Supporting analytical methods, appropriate validation data and storage
stability data are still required to accompany any submitted data
pertaining to the magnitude of the residue.

Information regarding whether the registrant submitted data on the
applicability of the FDA Multiresidue Protocols needs to be provided.

Guideline requirements regarding magnitude of the residue data for root
and tuber vegetables, cucurbit vegetables, citrus fruits, pome fruits,
tree nuts, cereal grains, herbs and spices, and oilseeds are required.

Guideline requirements regarding residue decline in broccoli, lettuce,
peach, snap bean, and tomato are required.

Guideline requirements regarding magnitude of residue in potable water,
fish and irrigated crops remain outstanding.

No data reflecting residues in food products resulting from registered
uses are available.

The data requirements for meat, milk, poultry and eggs remain reserved
pending the results of acceptable ruminant and poultry metabolism
studies.

Data remain outstanding pertaining to residues of rotenone in or on any
plant commodity following registered pre-harvest applications, processed
food/feed stuffs, confined rotational crops and field accumulation in
rotational crops.

	10.3 Occupational/Residential Exposure

The following is a list of deficiencies and data gaps that need to be
resolved:

Occupational handler exposure estimates were based on surrogate data as
no chemical or application equipment specific exposure data was
available.  There are clearly limitations and uncertainties regarding
the use of the surrogate data to assess rotenone occupational handler
exposure because of the distinct differences in application sites (land
vs. water), however, HED can not currently define the extent of these
limitations and uncertainties.  Actual data for rotenone handler
exposure scenarios would provide better worker risk estimates.

11.0 Attachments

Barnes 2005.  Rotenone:  Summary of Product Chemistry Data for
Reregistration Eligibility Decision (RED) Document.  DP Barcode:
D307391.  P. Yvonne Barnes.  August 11, 2005.

Carter 2005. Usage Report in Support of Reregistration for the
Insecticide Rotenone (074002).  Jenna Carter.  August 3, 2005.

Hawkins 2005.  Review of Rotenone Incident Reports.  DP Barcode D307408,
Chemical #071003 and #071002.  Monica S. Hawkins.  August 9, 2005.

R. David Jones 2006.  Drinking Water and Swimmer Exposure Assessment for
Rotenone from the Piscicide Use.  D307383.  R. David Jones.  May 10,
2006.

Rotenone: Decisions on Critical Effects and Endpoint Selection.  Results
of the Meeting of the HED Hazard Science Policy Council.  PC Code:
071003.  DP Barcode: D307370.  TXR# 0053480.  Diana Locke.  June 28,
2005.

Smith 2006.  Rotenone: Phase 5 Occupational and Residential Exposure
Assessment for the Reregistration Eligibility Decision Document.  PC
Code: 071003.  DP Barcode: 307387.  Charles Smith.  May 30, 2006.

12.0 References

CDFG 1991.  California Department of Fish and Game.  Pesticide
investigations unit, aquatic toxicology laboratory 1990 annual progress
report.  CDFG, Environmental Services Division, Sacramento, CA.

Health & Safety Report; HS – 1772.  A report on the illnesses related
to the application of rotenone to Lake Davis.  M. Verder-Carlos and M.
O’Malley.  California Environmental Protection Agency.  Department of
Pesticide Regulation.  November 12, 1998.

Appendix A: Executive Summaries for Studies not Highlighted in Document
and Toxicological Profile

1.  Subacute Neurotoxicity Study (Rat) (MRID# 45279501):

EXECUTIVE SUMMARY: In this special neurotoxicity study (MRID# 45279501),
a group of  25 Lewis rats  were given  doses  of 2.5-2.75 mg/kg/day of
rotenone dissolved in polyethylene glycol and DMSO by chronic
intravenous infusion for  1-5 weeks.  A variety of  immunocytochemical
and neuropathological tests, and some behavioral observations were used
to assess the impact of  treatment.  Among treated rats, 12/25 had
lesions, while no vehicle control rats did.  Complex I was inhibited
[73%] throughout the brain, but Complex II and IV were unaffected.  But
the level of  Complex I inhibition did not impair cellular respiration
in the brain.  Rotenone induced specific neurodegenerative lesions in
nigrostriatal dopaminergic neurons as evidenced by immunocytochemical
markers, silver staining, and Fluoro-B Jade staining.  Lesions were dose
dependent and typically began as focal lesions in the anterior striatum
and spread to most of the motor striatum, and in some rats in the pars
compacta substantia nigra cell bodies.  Only pre-synaptic dopamineric
nerve terminals were affected.  GABA neurons, which comprise 90% of
striatal neurons, and cholinergic neurons were unaffected.  Rotenone
treated rats with lesions also showed hypoactivity, unsteady gait, and
hunched posture.  Giasson and Lee (MRID# 45279502) discuss how this
study provides further evidence that environmental factors may play a
role in Parkinson's disease.  It does not provide new information
itself.

2.  Subchronic Dog (MRID# 00141406)

EXECUTIVE SUMMARY: In a subchronic oral toxicity study (MRID# 00141406),
rotenone (> 99% a.i., lot no. 578-RSP-1424, Sample No. 9244-RC) was
administered daily in gelatin capsules to 6 beagle dogs/sex/dose at dose
levels of 0, 0.4, 2.0, or 10.0 mg/kg bw/day for 26 weeks.  Individual
animal data were not included in the report and body weight and food
consumption data were presented graphically.

One low-dose male was sacrificed on day 52 due to an injury; all
remaining animals survived to scheduled sacrifice.  The first clinical
sign attributed to the treatment compound was emesis by dogs of the
high-dose group (10.0 mg/kg), which began after the second dose.  After
the first week of treatment, the incidence declined to, and remained at,
an incidence comparable to that of the control group.  Soft stools
and/or diarrhea were the second most common clinical sign among treated
animals, occurring at the highest incidence in the 10.0 mg/kg animals
with males more frequently affected than females.

100 gm) throughout the study and occasionally for the mid-dose
females (25-50 gm).  Data were not available to calculate food
efficiency, however, qualitative evaluation of food consumption values
and reductions in body weight gain at the mid- and high- dosages
indicated reduced food efficiency, a toxicologically significant effect
of the treatment compound.

Beginning at approximately the 8th week of treatment, the hemoglobin (M
7%, F15%), hematocrit (M 7%, F 13%), and erythrocyte count (M 7%, F 7%)
were decreased in high-dose males and females.  This effect was more
pronounced in females.  Because mean corpuscular volume, methemoglobin
and reticulocyte counts were normal, and no hemosiderotic lesions were
reported at any dose, the mild anemia was considered normocytic and
normochromic.  Reductions in cholesterol and glucose levels in high-dose
males (93% and 92%, respectively, of control) and females (66% and 88%,
respectively, of control) occurred at week 26.  Combined with the body
weight data, results of clinical pathology indicate a pronounced
inanition in high-dose animals.

Absolute and relative (to brain) liver weights were reduced in high-dose
males (83% and 88% of control) and females (82% and 84% of control,
respectively).  Absolute and relative (to brain) kidney weights were
reduced in high-dose females (79% and 82% of control, respectively), as
were absolute and relative (to brain) weights of the gonads in high-dose
females (64% and 63% of the control).  However, the absence of
associated histopathology or clinical chemistry changes suggested that
the reductions in weight of some organs were due to lower body weight.

Under the conditions of this study, the LOAEL for rotenone in male and
female beagle dogs is 2.0 mg/kg bw/day, based on treatment-related
inanition.  The NOAEL for rotenone in male and female beagle dogs 0.4
mg/kg bw/day.

This subchronic oral toxicity study in dogs is Acceptable/Guideline and
satisfies the guideline requirement for a subchronic study in dogs
[OPPTS 870.3150 (§82-1b)].

3.  Oncogenicity Rat (MRID# 00143257):

EXECUTIVE SUMMARY: This study (MRID# 00143257) was conducted to verify
previously published reports of mammary tumor incidence in rats dosed
with rotenone.  Rotenone (>95% a.i., S.S. Penick and Co., Orange, N.J.)
suspended in corn oil was administered intraperitoneally or orally by
gavage.  Twenty-five male and 25 female Sprague-Dawley rats/group were
dosed with 1.7 or 3.0 mg/kg/day by intraperitoneal injection 7 days/week
for 42 days.  Control groups of 15 males and 15 females were dosed
intraperitoneally with the vehicle only (0.1 mL corn oil) with the same
protocol.  Rats were observed for 17 months post-dosing prior to
necropsy.  The second study dosed 25 male and 25 female Wistar rats by
oral gavage 7 days/week for 42 days with 0, 1.7 or 3.0 mg/kg/day.  The
rotenone in corn oil was given in 0.25 mL volumes.  Rats were then
observed for 12 months post-dosing prior to necropsy.

Body weight in male and female rats was presented in graph form for the
intraperitoneal study.  Examination of the graph showed no significant
difference in the treated groups.  The only tumor noted was fibroadenoma
of the mammary gland observed in both control and dosed animals at the
same incidence.  These were seen in 7/21 females in the 3 mg/kg group,
13/25 females in the 1.7 mg/kg group, 8/15 females and 3/14 males in the
control group.  This does not indicate a treatment-related increase in
incidence.

Body weight from the oral study was also presented in graph form and
again no significant difference in body weight could be observed.  No
increased incidence of mammary tumors was noted between the treated
groups.  Mammary ductal ectasia and cysts were seen at a slightly
increased incidence in the treated females.  Ectasia occurred in 1/25 of
the controls, 4/24 in the 1.7 mg/kg group and 6/24 in the 3.0 mg/kg
group.  Cysts occurred in 4/25 of controls, 3/24 in the 1.7 mg/kg group
and 6/24 in the 3.0 mg/kg group.

At the doses tested, there was no treatment related increase in mammary
tumor incidence in any group.  Dosing appeared to be inadequate based on
the rat’s ability to maintain body weight and there was no evidence of
systemic toxicity.

This carcinogenicity study in the rat is Unacceptable/Non-guideline and
does not satisfy the guideline requirement for a carcinogenicity study
[OPPTS 870.4200; OECD 451] in rats.

4.  Oncogenicity & Reproductive Toxicity Hamster (MRID# 00143256):

EXECUTIVE SUMMARY:  In both reproductive and carcinogenic studies (MRID#
00143256), rotenone ( >95 % a.i., S.S. Penick and Co., Orange, N.J.)
suspended in 1% corn oil and mixed in chow meal was fed to groups of
Syrian Golden hamsters.  In the reproductive study, 25 male and 50
female hamsters were administered 1000 ppm for four months prior to and
during mating and 50 male and 50 female hamsters were administered 500
ppm for 3 months prior to and during mating.  A control group of 50 male
and 50 females was fed 1% corn oil and chow meal.  In the
carcinogenicity study, 50 male and 50 female hamsters/group were dosed
with 0, 125, 250, 500 or 1000 ppm rotenone and 1% corn oil in chow meal
for 18 months.  Based on a food factor of 0.083 for the hamster, dietary
concentration of 125, 250, 500 or 1000 ppm results in doses of 10, 21,
42 and 83 mg/kg/day, respectively.

In the reproductive study, 3 male and 12 female hamsters treated with
the 1000 ppm diet died during the first two months.  Surviving hamsters
in the 1000 ppm group exhibited  temporary decreases in food consumption
after week five and had rough hair coats and some weight loss although
these trends reversed by week nine.  No data on body weight or food
consumption were provided.  No specific details on the early deaths were
reported.  While mating was confirmed by the presence of vaginal plugs,
no pregnancies occurred in the 1000 ppm treated group implying that one
or both sexes were unfertile.  Males were observed grossly to have
decreased testicular size although no actual measurements were recorded.
 The 500 ppm treated group resulted in cannibalization or neglect of the
young by dams in both the F1a and F1b generations with all pups being
reported as smaller than normal although weight was not recorded.  For
the 0 ppm group, healthy offspring were produced in the F1a and F1b
generations.  The study was terminated after 6 months for the treated
groups and 10 months for the control group at the request of the EPA
Project Officer.

In the carcinogenesis study, hamsters in each group were weighed weekly
for the first 6 months, then bi- or tri-weekly thereafter.  Feed
consumption was measured weekly. Data were reported in graph form only.
Based on the graphs, decreased weight gain can be seen in the 1000 ppm
treated groups compared to the controls.  Spontaneous death occurred
with the same frequency in all groups including the controls during the
first 12 months of the study.  Necropsy was performed on all but five of
the 177 early decendents.  Enteritis/Typhlitis was the predominant
findings on the spontaneous deaths. All animals were examined grossly
upon death for evidence of tumors but only the 0, 125 and 1000 ppm
groups had tissues fixed for histopathological examination.  Adrenal
cortical carcinomas in 1/32 males and 2/33 females were presented only
in the 1000 ppm group.  Adrenal cortical hyperplasia and adrenal cortex
adenoma were seen in all groups with no treatment-related incidence.

Doses of rotenone (500 ppm) demonstrated embyotoxic effects, however,
lower levels were not tested thus a NOAEL could not be identified.

In the carcinogenicity study, 1000 ppm resulted in toxicity (depressed
body weight compared to the controls) but gross and histopathological
examination did not indicate any treatment-related increased incidence
of tumors.  However, diseased hamsters were used in the carcinogenicity
study and thus caused excessive death in controls (96% in females) and
LDT (86%), invalidating any comparison with dosed groups.  Therefore,
the validation of the adrenal tumors observed in the study is
compromised by disease in the colony of animals tested.

These studies are classified as Unacceptable/Non-guideline and do not
satisfy the guideline requirement for a carcinogenicity study (870.4200)
or reproduction study (870.3800).  This study(ies) is unacceptable
since: a) the reproduction study was inadequately described for body
weight s of parents and offspring, infertility, and testes weights; b)
offspring from the first and second matings were inadequately described;
c) only two dose levels were used with excessive toxicity at the HDT; d)
mating the F1 generation apparently did not occur; and e) no NOAEL was
shown.

Testing of rotenone levels below 500 ppm is recommended for the
reproductive study and another carcinogenicity study without a
significant number of early mortalities is recommended.

5.  Metabolism and Pharmacokinetics Rat (MRID# 00145496):

 position, Lot Nos. 500507 and 801110, purity 94.64%; unlabeled
rotenone purity 99.23%. Lot No. 100287) was administered to male and
female Sprague Dawley rats.  In a preliminary balance study, one male
and one female rat/group received a single 0.1 mg/kg or 5 mg/kg dose
administered by gavage or by i.v.  For the main study, groups of 5 male
and 5 female rats received a single i.v. dose of 0.01 mg/kg 14C-rotenone
via the tail vein; groups of 5 male and 5 female rats received a single
gavage dose of 0.01 mg/kg 14C-rotenone; groups of 5 males and 5 females
received 14 daily 0.01 mg/kg gavage doses of unlabeled rotenone followed
by a single gavage dose of 0.01 mg/kg 14C-rotenone; and groups of 5 male
rats and 5 female rats received a single gavage dose of 5 mg/kg
14C-rotenone.  In addition, groups of 6 male and 6 female rats received
a single gavage dose of 5 mg/kg 14C-rotenone or a single i.v. dose of
0.01 mg/kg 14C-rotenone to investigate enterohepatic circulation.

Whether administered orally or by i.v., the preliminary study showed the
primary route of elimination of rotenone was in the feces.  None of the
radiolabel was detected in the expired air and <5% of the radiolabel was
recovered in the urine.  Greater than 70% of the administered dose was
eliminated within 48 hours of treatment.

In the main study, male and female rats excreted 79.67% and 85.88%,
respectively, of a 0.01 mg/kg i.v. dose of radiolabeled rotenone in the
feces.  Of this, male rats excreted 46.8% and female rats excreted 53.8%
within 48 hours of treatment.  Urinary elimination accounted for 2.96%
and 3.02% in males and females, respectively, while cage debris
accounted for 2.53% and 7.71% respectively.  Following oral
administration of 0.01 mg/kg of radiolabeled rotenone, 95.88% of the
administered dose was excreted into the feces of male rats with 86.5%
eliminated within 48 hours.  Female rats excreted 79.14% of the dose in
the feces with 70.41% of the dose within 48 hours.  Urinary excretion
accounted for 2.41% and 4.22% of the administered dose in males and
females respectively.  Similar results were found in the multi-low dose
study.  Male rats that received 14 daily doses of 0.01 mg/kg unlabeled
rotenone followed by a single 0.01 mg/kg labeled dose of rotenone
excreted 89.86% of the dose in the feces with 85.1% of the dose excreted
in 48 hours.  Females excreted 94.15% of the dose in the feces with
88.59% within 48 hours.  Males and females excreted 3.43% and 2.74% of
the labeled rotenone dose in the urine.  Male and female rats treated
orally with a single 5 mg/kg of rotenone excreted 79.14% and 78.77% of
the dose in the feces, respectively and 3.09% and 3.22% in the urine.
These results show that elimination is rapid and fecal excretion is the
primary route of elimination of rotenone.  Results also suggest that
female rats excrete slightly more rotenone in the urine than male rats.

In conjunction with fecal elimination, extensive enterohepatic
circulation occurred.  Hepatic portal plasma to cardiac plasma ratios
shows a greater concentration of radiolabel in the portal vein whether
the dose was administered i.v. (1.7 x) or orally (2.2x males, 1.6x
females).  Tissue accumulation was low for all dosing groups, typically
being <1% of the administered dose.  As would be expected, organs
involved with elimination of the test material had the greatest
concentrations of radiolabel up to 144 hours after treatment.  These
included the liver and kidney with 0.7% and 0.15% of the administered
dose, respectively.

Following i.v. administration, the distribution/elimination half-life
was 1.1 hours with a biological half-life of 14 hours.  After oral
dosing, the distribution/elimination and biological half-lives were
similar (2.4 hours and 18 hours, respectively).

Metabolic profiles could not be obtained from the feces of male and
female rats treated with 0.01 mg/kg rotenone orally or by i.v.  Seven
metabolites were found in the feces of male and female rats treated with
5 mg/kg rotenone.  Polar metabolites accounted for 40.82-72.99% of the
metabolites from male rats and 33.48-65.76% from female rats.
Pretreatment of the fecal extracts with glucuronidase and aryl sulfatase
did not affect the metabolic profile.  No parent compound was
identified.  In the urine of male rats, 69.67-93.97% of the metabolites
were identified as polar while 43.51-94.88% was identified as polar in
female rat urine.

This metabolism study in the rat is classified Acceptable/Non-guideline
because it does not satisfy the guideline requirement for a metabolism
study [OPPTS 870.7485, OECD 417].  However, sufficient data is provided
to show the metabolic disposition of rotenone.

6.  Gene Mutation Salmonella typhimurium: (MRID# 40170506):

g/plate +/- S9.  No cytotoxicity study was included in the report but
the number of revertants observed for each dose and treatment condition
gave no indication of cytotoxicity.  The positive controls induced the
appropriate responses in the corresponding strains. There was no
evidence of induced mutant colonies over background for any tester
strain at any concentration, either with or without metabolic activation
with microsomes from rat or hamster liver.

This study is classified as Acceptable/Guideline and satisfies the
guideline requirement for OPPTS 870.5100; OECD 471 for in vitro
mutagenicity bacterial reverse gene mutation data.

7.  Gene Mutation Salmonella typhimurium (MRID# 40170502):

g/plate in the presence and absence of Aroclor 1254-induced rat liver
microsomes added along with the tester strain and the test chemical to
top agar and overlaid on minimal bottom agar (plate incorporation
procedure).  The plates were incubated under unspecified conditions.
Rotenone was tested up to concentrations of 10,000 g/plate, although
some precipitation became noticeable at 48 g/plate and became heavier
at 5000 ug/plate and above in a preliminary toxicity assay.  No
cytotoxicity of rotenone was noted at any dose or with any tester strain
either with or without S9 activation. 1,3-propane sulfone,
2-nitrofluorene and 2-aminoanthracene were used as positive controls.

Each dose, vehicle control and positive control was tested in triplicate
and two separate assays were conducted.  The arithmetic mean of the
revertants on the triplicate plates was determined and the results were
considered to be positive if the number of revertants at any test
concentration was at least double that of the vehicle control and a
dose-related increase in the number of revertants/plate was observed.

The positive controls induced the appropriate responses in the
corresponding strains. There was no evidence of induced mutant colonies
over background for any tester strain at any concentration, either with
or without S9 activation with rat liver microsomes.

This study is classified as Acceptable/Guideline and satisfies the
guideline requirement OPPTS 870.5100; OECD 471 for in vitro mutagenicity
bacterial reverse gene mutation data.

8.  Gene Mutation Mouse lymphoma cells (MRID# 40170505):

g/ml and the vehicle control had a mutation frequency of 59 per 106
cells.  In the repeat experiment the mutation frequency ranged from 116
to 268  per 106  cells as the rotenone concentration was increased  from
0.25 to 2.0 g/ml and the vehicle control had a mutation frequency
of 71 per 106 cells.  Concentrations of 8.0 and 4.0 g/ml rotenone
were lethal in the first and second experiments, respectively.  All
concentrations of the test chemical produced mutation frequencies
significantly (p<0.05) above the vehicle control values.  The positive
controls in both experiments showed the appropriate response. There was
evidence that rotenone caused a concentration-related positive response
of induced mutant colonies over background in both experiments.

This study is classified as Acceptable/Guideline and satisfies the
guideline requirement OPPTS 870.5300, OECD 476 for in vitro mutagenicity
(mammalian forward gene mutation) data.

9. Cytogenetics (Chinese hamster ovary) (MRID# 40179801c):

g/ml without activation (repeat assays), and 0, 100, 150, 200 or 250
g/ml with metabolic activation using rat liver microsomes induced
with Arochlor 1254.  Exposures of the cells to the test material, and
positive and negative controls were for 8-10 hours (non-activated) and 2
hours (activated).  A preliminary cytotoxicity assay of Rotenone was not
reported. The protocol stated that the cytotoxicity assay was
incorporated into the actual assay with a five-log range of
concentrations of test material in a half-log series of concentrations.
Because of significant chemical-induced cell cycle delay, incubation
time before addition of colcemid was lengthened to 21.5 hours (Trial 1)
and 20.5 hours (Trial 2) to provide sufficient metaphases at harvest.
Positive controls (mitomycin C-S9; cyclophophamide +S9) were included in
each trial.

The first test results without activation were equivocal.  There was an
increase in aberrations at 25 g/ml but not at 50 g/ml (highest
dose tested in the first assay). The repeat study did not show any
positive results at 25, 50 or 100 g/ml.  The positive controls
indicated that the assay was working properly.  Only one assay was
conducted with activation and it was negative.  Significant cell-cycle
delay was induced by the test chemical, indicating that sufficient
cytotoxicity was obtained.  There was no evidence of chromosome
aberrations induced over background, either with or without activation.

This study is classified as Acceptable/Guideline, and satisfies the
guideline requirement for in vitro mammalian cytogenetics - chromosome
aberrations in Chinese hamster ovary cells OPPTS 870.5375; OECD 473.

10.  Cytogenetics (rat) and Micronucleus (mouse) (MRID# 00093702):

EXECUTIVE SUMMARY: In whole animal cytogenetics assays [Chromosome
aberration study in rats (8-10 week old Sprague Dawley males) and
micronucleus study in mice (8-10 week old ICR Swiss males and females)]
(MRID# 00093702), animals were gavaged daily for 2 days with rotenone
dissolved in corn oil.  Groups of ten rats received doses of 0, 0.7, 2.5
or 7.0 mg/kg, of the test agent and ten positive control rats received
1.0 mg/kg of triethylene melamine (TEM) given intraperitoneally (i.p.).
The highest test dose was ~1/10th of the estimated rat oral LD50 based
on a preliminary toxicity study done by the same lab.  Groups of eight
mice received doses of 0, 10, or 80 mg/kg of the test agent and eight
received 1.0 mg/kg of TEM given i.p.  The highest test dose was the
estimated mouse oral LD50 based on a preliminary toxicity study done by
the same lab.

Forty-five hours after the second dosing, rats were treated with
colchicine (4 mg/ml) to arrest cells in metaphase.  Three hours later
bone marrow cells were collected, hypotonically treated, fixed, stained
and mounted.  Cells (400/animal) were examined for chromatid/chromosome
gaps, breaks, fragments, minutes or other aberrations. Cytotoxicity was
determined by measuring the mitotic index (1000 cells/dose group).  The
report had no indication of overt toxicity at any dose.  The frequency
of chromatid/chromosome aberrations was 0.88, 0.35, 1.1, and 0.43% for
the 0, 0.7, 2.5 and 7.0 mg/kg dose groups, respectively.  Positive
control data were not presented.  The mitotic indices for the
corresponding groups were 26.3, 23.3, 28.7 and 30.1%.  Based on a
statistical analysis using Student’s t test, there was no evidence
that the test material induced chromatid/chromosome aberrations in rat
bone marrow cells over background.

Six hours after the second dosing of the mice, bone marrow cells were
collected, smeared on glass slides, dried, fixed, stained and mounted.
Polychromatic and normochromatic erythrocytes (1000 each) from each dose
group and the positive control were scored for micronuclei.  The
frequencies of polychromatic erythrocytes with micronuclei were 0.043,
0.031 and 0.029% in the 0, 10 and 80 mg/kg dose groups, respectively;
the frequencies of normochromatic erythrocytes with micronuclei were
0.044, 0.038 and 0.038% in the 0, 10 and 80 mg/kg dose groups,
respectively.  There was no indication that the test material was toxic
to the test animals.  Positive controls showed appropriate responses for
both the polychromatic and normochromatic erythrocytes. Based on probit
analysis, the test material did not produce a significant increase in
the frequency of micronuclei in polychromatic or normochromatic
erythrocytes from bone marrow.

g/ml), these assays were not likely to detect potential genotoxicity
and have been previously classified as unacceptable (Reviewed by the
Toxicology Branch (6-14-82): Memorandum to W. Miller, Registration
Division. From R. Gardner. Subject: Review of Mutagenicity Assays with
Rotenone. EPA Reg. No. 6704-Q. Acc. No. 246587, Tox. Chem. No. 725).

This study is classified as Unacceptable/Non-Guideline, and does not
satisfy the guideline requirement for in vivo mammalian cytogenetics -
OPPTS 870.5385 (§84-2) OECD 475 Bone Marrow Chromosomal Aberration Test
in the Rat and OPPTS 870.5395 (§84-2) OECD 474 Erythrocyte Micronucleus
Test in the Mouse.  In addition, classification of the Drosophilia
melongaster vicia fabia assays are Unacceptable.  The primary reason for
this classification of the rodent assay as also being unacceptable is
because the maximum tolerated dose (MTD) was not achieved in either the
rat or the mouse assays.

11.  Mitotic gene conversion (Saccharmomyces cerevisiae) (MRID#
00144292):

EXECUTIVE SUMMARY:  In a mitotic gene conversion assay in diploid yeast
(MRID# 00144292), strain D4 of Saccharomyces cerevisiae was exposed to
rotenone (Batch #. 100287 and purity >97%), dissolved in ethanol at
concentrations of 0, 1, 10, 100, 500, 1000, 2500, 5000 and
10,000 g/plate in the presence and absence of microsomes from livers
of Aroclor 1254-induced Sprague-Dawley rats.  The test material, yeast
cells and buffer or microsomes were mixed with 0.6% agar and poured onto
minimal agar plates and incubated at 30 C for ~4 days before scoring
for tryptophan convertant colonies.  The D4 strain measures only mitotic
gene conversions, which involve nonreciprocal crossover events.
Toxicity tests showed that even at the highest tested dose, viability of
the D4 strain was ~95%.  Ethyl methanesulfonate was used as a positive
control without activation, and. 2-anthramine was used as a positive
control with activation.  However, it was noted by the author that
positive controls with activation were historically inconsistent.

Each dose, vehicle control, and positive control was tested on a single
plate.  The positive control, without activation, induced the
appropriate response, but the positive control with activation showed no
increase in gene conversion events above the vehicle control. There was
no evidence of induced mutant colonies over background for any test
concentration, either with or without metabolic activation up to levels
in excess of the limit dose (5000 g/plate).

This study is classified as Acceptable/Guideline and satisfies the
requirement for OPPTS 870.5575 [§84-2]; OECD 481 for a yeast mitotic
gene conversion assay.

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Gg/plate (in excess of the limit dose of 5000 g/plate) gave no
evidence of induced mutant colonies over background for either strain,
either without or with activation.  Positive controls without activation
gave appropriate responses in both strains but positive controls with
activation showed no increase in revertants above the vehicle control.
(2) A mitotic recombination assay, repeated twice, using S. cerevisiae
diploid strain D5 at dose levels of the test material up to 10,000
g/plate gave no evidence of induced mutant colonies over background,
either without or with activation. Positive controls without activation
gave appropriate responses, as did positive controls with activation,
although the positive controls with activation gave widely different
mutation frequencies in the repeated trials.  (3) A mouse somatic cell
mutation test (spot test) was carried out by treating pregnant females,
by gavage, with the test material dissolved in corn oil or corn oil plus
DMSO, on days 8 through 11 of gestation, with doses of 0.05, 0.17. 0.5
or 1.0 mg/kg.  Seven females receiving 0.17 mg/kg rotenone in DMSO, 11
females dosed with 0.5 mg/kg rotenone in DMSO, and 8 females
administered 1.0 mg/kg rotenone in DMSO were found dead versus 5 in the
DMSO negative control group.  Other signs of compound toxicity included
lethargy and clamminess.  When the test material was prepared in corn
oil at 1000 mg/kg, 11 deaths were recorded as compared to no deaths in
the vehicle control group.  The treatment did not cause any melanocyte
toxicity nor did it induce any somatic mutations in the embryonic
melanocytes.  Positive controls using ethyl nitrosourea induced the
appropriate response.  An additional treatment with 1000 mg/kg of the
test material, administered to pregnant mice under the same conditions,
caused melanocyte toxicity but did not produce any somatic mutations.

The results of all four studies support the conclusion that rotenone was
not genotoxic under the limited conditions of the experiments.
Inconsistent results in the yeast studies using known mutagens that
require activation (e.g., dimethyl nitrosamine) cast doubt on the
reliability of the findings.  In the mouse spot test, death and other
clinical signs noted at the highest dose tested (1000 mg/kg in corn
oil).  There was, however, no cytotoxic effect or mutagenic effect on
the target cell (melanocyts).

TOXICOLOGY DATA REQUIREMENTS

	The requirements (40 CFR 158.340) for food use for rotenone are in
Table A1.  Use of the new guideline numbers does not imply that the new
(1998) guideline protocols were used.

Table A1.  Toxicology Data Requirements for Rotenone.

Test 	Technical

	Required	Satisfied

870.1100	Acute Oral Toxicity

870.1200	Acute Dermal Toxicity

870.1300	Acute Inhalation Toxicity

870.2400	Primary Eye Irritation

870.2500	Primary Dermal Irritation

870.2600	Dermal Sensitization		Yes

Yes

Yes

Yes

Yes	Yes

Yes

Yes

Yes

Yes

Yes

870.3100	Oral Subchronic (rodent)

870.3150	Oral Subchronic (nonrodent)

870.3200	21-Day Dermal

870.3250	90-Day Dermal

870.3465	90-Day Inhalation		Yes

Yes

Yes

no

no	Yes1

Yes

No2

-

-

870.3700a	Developmental Toxicity (rodent)

870.3700b	Developmental Toxicity (nonrodent)

870.3800	Reproduction		Yes

Yes

Yes	Yes

No

Yes

870.4100a	Chronic Toxicity (rodent)

870.4100b	Chronic Toxicity (nonrodent)

870.4200a	Oncogenicity (rat)

870.4200b	Oncogenicity (mouse)

870.4300	Chronic/Oncogenicity		Yes

Yes

Yes

Yes

Yes	Yes1

No

Yes

Yes

Yes

870.5100	Mutagenicity—Gene Mutation - bacterial

870.5300	Mutagenicity—Gene Mutation - mammalian

870.5xxx	Mutagenicity—Structural Chromosomal Aberrations

870.5xxx	Mutagenicity—Other Genotoxic Effects		Yes

Yes

Yes

No	Yes

Yes

Yes

-

870.6100a	Acute Delayed Neurotox. (hen)

870.6100b	90-Day Neurotoxicity (hen)

870.6200a	Acute Neurotox. Screening Battery (rat)

870.6200b	90 Day Neuro. Screening Battery (rat)

870.6300	Develop. Neurotoxicity		No

No

No

Yes

No	-

-

-

No3

-

870.7485	General Metabolism

870.7600	Dermal Penetration		Yes

Yes	Yes

No4

Special Studies for Ocular Effects

Acute Oral (rat)

Subchronic Oral (rat)

Six-month Oral (dog)

No

No

No

-

-

-

1Requirements for this study are fulfilled by the chronic/oncogenicity
rat feeding study.

2 A dermal toxicity study with neurotoxicity parameters is recommended.

3An inhalation neurotoxicity (rat) study has been recommended.

4CFR 158.340 (24): Dermal absorption studies required for compounds
having a serious toxic effect as identified by oral or inhalation
studies, for which a significant route of human exposure is dermal and
for which the assumption of 100 percent absorption does not produce an
adequate margin of safety.  Registrants should work closely with the
Agency in developing an acceptable protocol and performing dermal
absorption studies.

 Form 8570-4.  Item 10: Components of Formulation.  “Each component
that may have toxic effects must be listed separately, even if present
at less than 0.1% by weight.”  Guidelines on estimating % limits on
components can be found in 40 CFR 158.175.

 Reported environmental incidents (Health & Safety Report; HS – 1772,
1998) have shown measurable concentrations of volatile organic compounds
(trichloroethylene, toluene, xylene), semi-volatile organic compounds
(2-methyl-naphthylene, 1-methyl naphthylene, naphthylene, ethyl
benzene), and nonvolatile organic compounds (piperonyl butoxide, benzoic
acid), after applications of rotenone to bodies of water for piscicidal
use.  See review in RDavid Jones 2006.  Most current CSFs do not list
and/or quantify the impurities.  Updated CSFs that abide by EPA
regulations are needed.

 Betarbet R., TB Sherer, G MacKenzie, M Garcia-Osuna, AV Panov, JT
Greenamyre 2000. Chronic systemic pesticide exposure reproduces features
of Parkinson’s disease. Nature neuroscience 3(12) 1301-1306 (MRID
45279501).

 Sherer TB, Betarbet R, Stout AK, Lund S, Baptista M, Panov AV, Cookson
MR, Greenamyre JT (2002). An in vitro model of Parkinson’s disease:
linking mitochondrial impairment to altered α-synuclein metabolism and
oxidative damage. J Neuroscience 22:7006-7015.

 Sherer TB, Betarbet R, Kim JH, Greenamyre JT (2003). Selective
microglial activation in the rat rotenone model of Parkinson’s
disease. Neuroscience Letters 341 87-90.

 Spillantini MG, Schmidt ML, Lee VM, Trojanawski JQ, Jakes R, Goedert M
(1997).  Alpha-synuclein in Lewy bodies.  Nature 388:839-840.

 Wooten GF (1997). Neurochemistry and neuropharmacology of
Parkinsons’s disease. In: Movement disorders:neurologic principles and
practice (Watts RL, Koller WC, eds), pp 153-160. New York: McGraw-Hill.

 Sherer TB, Kim JH, Betarbet R, Greenamyre JT (2003). Subcutaneous
rotenone exposure causes highly selective dopaminergic degeneration and
alpha-synuclein aggression. Exp Neurol 17:9-16.

 Sherer TB, Betarbet R, Testa C, Byoung BS, Richardson JR, Kim JH,
Miller GW, Yagi T, Matsuno-Yagi A, Greenamyre JT (2003). Mechanism of
toxicity in Rotenone models of Parkinson’s disease. The Journal of
Neuroscience 23(34):10756-10764.

 Fleming SM, Zhu C, Fernagut PO, Mehta A, DiCarlo CD, Seaman RL, and
Chesselet MF (2004). Behavioral and immunohistochemical effects of
chronic intravenous and subcutaneous infusions of varying doses of
rotenone. Experimental Neurology 187 pp 418-429.

 Entrez PubMed website available at:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi

 Barlow B.K., Richfield E.K., Cory-Slechta D.A., and Thirsuchelvam M.
2004. A fetal risk factor for Parkinson’s disease. Dev. Neurosci.
4(26): 11-23.

 Melamed E., Rosenthal J., and Youdim M.B.H. 1990. Immunity of fetal
mice to prenatal administration of the dopaminergic neurotoxin
1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine. J. Neurochem. 55:
1427-1431.

 Eriksson P., Johansson U., Ahlbom J., and Fredriksson A 1993. Neonatal
exposure to DDT induces increased susceptibility to pyrethroid
(bioallethrin) exposure at adult age- Changes in cholinergic muscarinic
receptor and behavioral variables. Toxicology. 77:21-30.

 Eriksson P.  1996. Developmental neurotoxicology in the neonate-
Effects of pesticides and polychlorinated substances. Arch. Toxicol.
Suppl. 18: 81-88.

 Gupta a., Agarwal R., and Shukla G.S., 1993. Functional impairment of
the blood-brain barrier following pesticide exposure during early
development in rats. Hum. Exp. Toxicol. 18: 174-179.

 Thiruchelvam M., Richfield E.K., Goodman B.M., Baggs R.B., and
Cory-Slechta D.A., 2002. Developmental exposure to pesticides paraquat
and maneb and the Parkinson’s disease phenotype. Neurotox. 33:
621-633.

 Haag HB (1931). Toxicological studies of Derris elliptica and its
constituents. I. Rotenone. J. Pharmacol. Exp. Ther. 43, 193-208.

 Lehman AJ (1954). A toxicological evaluation of household insecticides.
Q. Bull.-Assoc. Food Drug Off. 18, 3-13.

 Soloway SB (1976). Naturally occurring insecticides.  Environmental
Health Perspectives Vol. 14, pp 109-117.

 Clark NWE, Scott RC, Blain PG, Williams FM (1993). Fate of
fluazifop-butyl in rat and human skin in vitro. Arch Toxicol. 67:44-48.

 The dermal absorption human study for fluzifop-butyl is not subject to
review by the Human Studies Review Board (HSRB).

 This study was performed at Litton Bionetics, Inc. A detailed
presentation of the technique for detecting chromosomal aberrations was
referenced as Galloway et al. (1985).  The techniques were described as
“(a) Chinese ovary cells were incubated with study compound or
solvent, as indicated in (b) or (d).  Cells were arrested in first
metaphase by addition of cocemid and harvested by mitotic shake-off,
fixed, and stained in 6% Gemsa.  (b) In the absence of S9, cells were
incubated with study compound or solvent (acetone) for 8-10 hours at
37C. Cells were then washed, and fresh medium containing colcemid was
added for an additional 2-3 hours followed by harvest. (c) Because of
significant chemical-induced cell cycle delay, incubation time before
addition of colcemid was lengthened to 21.5 hrs (Trial 1) and 20.5 hrs
(Trial 2) to provide sufficient metaphases at harvest.  (d) In the
presence of S9, cells were incubated with study compound or solvent
(acetone) for 2 hours are 37C.  Cells were then washed, medium was
added, and incubation was continued for 8-10 hours.  Colcemid was added
for the last 2-3 hours of incubation before harvest.  S9 was from the
liver of Aroclor 1254-induced male Sprague Dawley rats.”

Galloway, S, Bloom A, Resnich M, Margolin B, Nakamura F, Archer P,
Zeiger E (1985).  Development of a standard protocol for in vitro
cytogenetic testing with Chinese hamster ovary cells: Comparison of
results for 22 compounds in two laboratories.  Environ. Mutagen. 7:1-51.
 The protocol fo this reference is Provided in TXR No. 009028

Page   PAGE  1  of   NUMPAGES  71

Page   PAGE  51  of   NUMPAGES  71

Page   PAGE  54  of   NUMPAGES  71

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460


[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22560-22563]
[FR Doc No: 2018-10246]

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

SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 33094; File No. 812-14765]

TCW Direct Lending LLC, et al.;

May 9, 2018.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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

    Notice of an application for an order under sections 12(d)(1)(J),
57(c), 57(i) and 60 of Investment Company Act of 1940 (the ``Act'') and
rule 17d-1 under the Act to permit certain joint transactions otherwise
prohibited by sections 12(d)(1)(A), 12(d)(1)(C), 57(a)(1), 57(a)(2) and
57(a)(4) of the Act and rule 17d-1 under the Act.

Applicants: TCW Direct Lending LLC (the ``Fund''), TCW Middle Market
Lending Opportunities BDC, Inc. (the ``Extension Fund''), and TCW Asset
Management Company (the ``Adviser'').

Summary of Application: Applicants seek an order to permit the Fund (i)
to conduct an exchange offer pursuant to which investors in the Fund
(``Unitholders''), including certain directors and officers of the Fund
and employees of the Adviser (collectively, the ``TCW Directors,
Officers and Employees''), may elect to exchange all or a portion of
their units in the Fund (``Units'') for an equivalent number of shares
(``Shares'') in the Extension Fund (each such Unitholder, an ``Electing
Unitholder''), and (ii) to transfer to the Extension Fund a pro rata
portion of the Fund's assets and liabilities, including a pro rata
portion of each of the Fund's portfolio investments, in proportion to
the percentage of Units tendered and accepted for exchange.

Filing Dates: The application was filed on April 20, 2017, and amended
on October 16, 2017, May 3, 2018, and May 9, 2018.

Hearing or Notification of Hearing: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on May 30, 2018 and should be accompanied by proof of service on
the applicants, in the form of an affidavit, or, for lawyers, a
certificate of service. Pursuant to section 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE, Washington, DC 20549-1090. The Applicants: c/o Adrian Rae
Leipsic, Esq., and Adam E. Fleisher, Esq., Cleary Gottlieb Steen &
Hamilton LLP, One Liberty Plaza, New York, New York 10006.

FOR FURTHER INFORMATION CONTACT: Asen Parachkevov, Senior Counsel, or
David J. Marcinkus, Branch Chief, at<PHONE_NUMBER> (Division of
Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Fund, a Delaware limited liability company, is a closed-end
management investment company that has elected to be regulated as a
business development company (``BDC'') under the Act. On April 18,
2014, the Fund filed a registration statement on Form 10 to register
Units pursuant to section 12(g) of the Exchange Act of 1934 (the
``Exchange Act''). The Fund commenced operations on September 19, 2014.
The Fund operates as a direct lending company that seeks to generate
risk-adjusted returns primarily through direct investments in senior
secured loans made to middle-market companies or other companies that
are engaged in various businesses.
    2. The Fund conducted a private offering of its Units to investors
in reliance on the exemption from registration provided by section 506
of Regulation D under the Securities Act of 1933 (the ``Securities
Act''). The Fund entered into subscription agreements with its
Unitholders, pursuant to which the Unitholders made capital commitments
to the Fund. The Units are not traded on an exchange and are not freely
transferable.
    3. The Extension Fund, a Delaware corporation and a wholly-owned
subsidiary of the Fund, intends to elect to be regulated as a BDC.
Applicants state that the Extension Fund will have investment
objectives and investment policies that are substantially similar to
the Fund's. Applicants state that the Extension Fund intends to conduct
an initial public offering or listing of its Shares immediately
following the completion of the Proposed Transactions.
    4. The Adviser, a Delaware limited liability company, is registered
as an investment adviser under the Investment Advisers Act of 1940 (the
``Advisers Act''). The Adviser serves as investment adviser to the Fund
pursuant to an investment advisory

agreement, and intends to serve as investment adviser to the Extension
Fund.
    5. Applicants state that the Fund's legal interest in each of its
existing portfolio investments is capable of being proportionally
assigned or similarly transferred on a pro rata basis. Applicants
further state that each of the credit agreements and loan documents
governing the terms of the Fund's assets, which primarily consist of
loans and other private investments in middle market companies, permits
an assignment, participation or similar transfer by the Fund without
the need for the written consent of any administrative or collateral
agent, borrower or other party.
    6. Applicants state that the Fund's limited liability company
operating agreement (the ``LLC Agreement'') provides that the Fund will
be dissolved upon the expiration of its six-year term on September 19,
2020 (subject to any extensions of the term in accordance with the
procedures set forth in the LLC Agreement), whereupon the Fund's assets
will be liquidated in an orderly manner, capital will be returned to
the Unitholders, and the Fund will wind up. Applicants state that the
Fund's organizational documents do not permit the Fund to conduct an
initial public offering of its Units, and the Fund has agreed that no
Unitholder will be required to participate in a publicly traded vehicle
without such Unitholder's consent.
    7. Applicants state that the Fund's LLC Agreement provides for the
ability of the Fund to engage in a ``split-off'' transaction, which, as
described below and in greater detail in the application, would be
implemented through the Exchange Offer, the Refinancing, the
Contribution Transaction and the Share Issuance (each defined below,
and, collectively, the ``Proposed Transactions''). The costs and
expenses of the Proposed Transactions will be borne by the Adviser.\1\
---------------------------------------------------------------------------

    \1\ All costs and expenses relating to the organization and
operation of the Extension Fund will be borne by the Extension Fund
as fully disclosed to investors prior to their decision to
participate in the Exchange Offer.
---------------------------------------------------------------------------

    8. If the requested order is granted, the Applicants propose to
conduct an exchange offer, pursuant to which each Unitholder may elect
to exchange a number of Units for an equivalent number of Shares (the
``Exchange Offer''). The Exchange Offer will be conducted as a private
placement pursuant to Regulation D and made in compliance with rule
13e-4 under the Exchange Act and section 23(c)(2) of the Act.
    9. Applicants state that the Exchange Offer will not commence
unless and until (1) the boards of the Fund and the Extension Fund (the
``Fund Board'' and the ``Extension Fund Board'', and collectively, the
``Boards''), including a ``required majority'' (as defined in section
57(o) of the Act (``Required Majority'')) of the directors of each
Board, authorize and approve the Proposed Transactions, and make all
necessary determinations, including among other things, that: (i) The
Proposed Transactions are in the best interests of the Fund or the
Extension Fund, as applicable, (ii) the interests of Unitholders who
elect to remain invested in the Fund and the interests of the Electing
Unitholders will not be diluted as a result of effecting the Proposed
Transactions, and (iii) following the Proposed Transactions, all
Unitholders, including the Electing Unitholders, will hold the same pro
rata interest in the same underlying portfolio investments as
immediately prior to the Exchange; (2) the Fund Board, including a
Required Majority, approves the participation in the Exchange by any
``remote'' affiliate of the Fund, as described in Section 57(d) of the
Act and as required under section 57(f) of the Act; and (3) the
Extension Fund Board, including a Required Majority, and the Fund, in
its capacity as initial shareholder of the Extension Fund, each approve
the investment advisory agreement between the Extension Fund and the
Adviser.
    10. Applicants state that simultaneously with the Share Issuance
(as defined below), the Fund will transfer to the Extension Fund a pro
rata portion of each of the Fund's assets and liabilities, including
each of the Fund's portfolio investments, in proportion to the
percentage of Units tendered by Electing Unitholders and accepted for
exchange (the ``Contribution Transaction''). Applicants state that such
computation will be objective and formulaic and determined solely on
the basis of the percentage of Electing Unitholders, and will not be
impacted by the valuation of the Fund's assets or any other factor that
would impart an element of discretion. Applicants further state that
material liabilities (other than those arising under the Fund's credit
facility) will also be proportionally transferred or transferred on a
pro rata basis by the Fund to the Extension Fund.
    11. Applicants state that simultaneously with the Contribution
Transaction, the Extension Fund will issue the applicable number of
Shares to each Electing Unitholder in exchange for the corresponding
number of Units accepted by the Fund from such Electing Unitholder in
the Exchange Offer (the ``Share Issuance'').
    12. Immediately prior to (and effectively contemporaneously with)
the closing of the Exchange, the Contribution Transaction and the Share
Issuance, (a) the Extension Fund will enter into a new credit facility
and draw down an amount equal to the pro rata portion of the Fund's
existing indebtedness immediately prior to the closing of the Exchange
Offer attributable to the Units that have been validly tendered by
Electing Unitholders and accepted for exchange, which amount will be
distributed to the Fund and will be used to pay down the Fund's current
outstanding senior secured revolving credit facility, and (b) the Fund
will enter into a new credit facility to drawn down an amount to pay
down the remainder of its existing credit facility (together, the
``Refinancing'').
    13. Applicants believe that the Proposed Transactions will result
in a number of benefits to Unitholders. Applicants state that the
Proposed Transactions will provide Unitholders with the optionality
that was negotiated for and was disclosed at the time of their
investment in the Fund and will enable Unitholders to participate in
the Extension Fund in a manner that promotes capital formation.
Applicants state that the Proposed Transactions will position the
Extension Fund to continue operations as a BDC with the goals of
achieving greater economies of scale and completing an initial public
offering or listing of its Shares. Applicants further state that by
allowing the Unitholders to elect to participate in the Extension Fund,
the Proposed Transactions will enable potential future retail investors
to benefit from alignment with sophisticated institutional investors
who elect to participate in the Extension Fund.

Legal Analysis

Section 57(a)(1) and 57(a)(2) of the Act

    1. The Applicants are requesting an exemption pursuant to section
57(c) from the provisions of sections 57(a)(1) and 57(a)(2), in order
to permit the Applicants to effect the Contribution Transaction and the
Share Issuance.
    2. Sections 57(a)(1) provides that it shall be unlawful for any
person who is related to a BDC in a manner described in section 57(b)
\2\, acting as principal, to sell to such BDC, or to a company
controlled by such BDC, any securities

or other property unless such sale involves solely (emphasis added) (i)
securities of which the buyer is the issuer or (ii) securities of which
the seller is the issuer and which are part of a general offering to
the holders of a class of its securities.
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    \2\ Section 57(b) specifies the persons to whom the prohibitions
of sections 57(a)(1), (a)(2) and (a)(4) apply.
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    3. Section 57(a)(2) provides that it shall be unlawful for any
person who is related to a BDC in a manner described in section 57(b),
acting as principal, to purchase from such BDC, or from a company
controlled by such BDC, any securities or other property except for
securities of which the seller is the issuer.
    4. Rule 57b-1 does not exempt the Fund and the Extension Fund from
being subject to the prohibitions of section 57(a).\3\ In addition, the
TCW Directors, Officers and Employees may be prohibited by section
57(a)(1) and (2) from participating in the Share Issuance as a result
of tendering their Units in the Exchange.
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    \3\ Rule 57b-1 exempts certain persons otherwise related to a
BDC in a manner described in section 57(b)(2) from being subject to
the prohibitions of section 57(a). Specifically, this rule states
that the provisions of section 57(a) shall not apply to any person:
(a) Solely because that person is directly or indirectly controlled
by a BDC; or (b) solely because that person is directly or
indirectly controlling, controlled by, or under common control with,
a person described in (a) of the rule or is an officer, director,
partner, copartner, or employee of a person described in (a) of the
rule (emphasis added).
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    5. Section 57(c) authorizes the Commission to issue an exemptive
order if (i) the terms of the proposed transaction, including the
consideration to be paid or received, are reasonable and fair and do
not involve overreaching of the BDC or its shareholders or partners on
the part of any person concerned, (ii) the proposed transaction is
consistent with the policy of the BDC, as recited in the filings made
by such company with the Commission under the Securities Act, its
registration statement and reports filed under the Exchange Act, and
its reports to shareholders or partners; and, and (iii) the proposed
transaction is consistent with the general purposes of the Act.
    6. The Applicants submit that the request for an exemption from the
provisions of section 57(a)(1) and (a)(2) meets the standards for an
order set forth in section 57(c). First, Applicants state that the
terms of the Contribution Transaction, including the consideration to
be paid or received, are fair and reasonable and involve no element of
overreaching, since the transfer by the Fund of a pro rata portion of
each of its assets and liabilities to the Extension Fund will be
determined solely on the basis of the percentage of Electing
Unitholders, which is purely an objective and formulaic exercise.
Second, the Applicants state that the Contribution Transaction and the
Share Issuance are consistent with the stated investment policies of
the Fund as fully disclosed to Unitholders. Finally, the Applicants
submit that the Boards, including a Required Majority of each, will
have approved and authorized, as well as made all required
determinations with respect to, the Proposed Transactions.

Section 57(a)(4) and Rule 17d-1, as Made Applicable to BDCs by Section
57(i) of the Act

    7. The Applicants are also requesting an Order pursuant to section
57(i) and rule 17d-1, to permit certain joint transactions that may be
otherwise prohibited by Section 57(a)(4) and rule 17d-1.
    8. Section 57(a)(4) makes it unlawful for any person who is related
to a BDC in a manner described in section 57(b), acting as principal,
knowingly to effect any transaction in which the BDC or a company
controlled by such BDC is a joint or a joint and several participant.
Section 57(i) provides that the rules under section 17(d) applicable to
registered closed-end investment companies are deemed to apply to
transactions subject to section 57(a). In relevant part, rule 17d-1
prohibits any person who is related to a BDC in a manner described in
section 57(b), acting as principal, from participating in, or effecting
any transaction in connection with, any joint enterprise or other joint
arrangement in which the BDC or a company controlled by such BDC is a
participant, unless an application has been filed with the Commission
and an order has been granted.
    9. The Fund and the Extension Fund may be viewed as affiliated
persons of each other in a manner described in section 57(b).
Considered together, the Proposed Transactions will require a
considerable degree of coordination among the Fund, the Extension Fund
and the Adviser that may indicate the existence of a ``joint
arrangement'' as described in rule 17d-1. Further, certain TCW
Directors, Officers and Employees who have invested in the Fund are
affiliated persons of the Fund pursuant to section 57(b).
    10. Rule 17d-1(b) provides that in determining whether to grant
such an order, the Commission will consider whether the participation
of the investment company in the joint transaction ``is consistent with
the provisions, policies and purposes of the Act and the extent to
which such participation is on a basis different from or less
advantageous than that of other participants.''
    11. The Applicants submit that the request for an order under
section 57(a)(4) and rule 17d-1 meets the standards set forth to rule
17d-1 for the same reasons as discussed above with respect to the
request for exemption from sections 57(a)(1) and (a)(2). The Applicants
state that TCW Directors, Officers and Employees will participate in
the Exchange pursuant to the same terms and documentation as all other
Unitholders, and the Proposed Transactions will not place any of the
Fund, the Extension Fund or existing Unitholders of the Fund in a
position less advantageous than that of any other of such persons. The
Applicants further submit that the terms of the investment advisory
agreement between the Extension Fund and the Adviser will be
comprehensively disclosed to all Unitholders in the Offer to Exchange,
the Fund and the Extension Fund will pay comparable management fees in
respect of overlapping investments transferred by the Fund to the
Extension Fund, and each Unitholder who wishes to remain invested in
the Fund will be subject to the Fund's existing fee structure without
any modification.

Sections 12(d)(1)(A) and 12(d)(1)(C), as Made Applicable to BDCs by
Section 60 of the Act

    12. The Applicants are requesting an exemption pursuant to section
12(d)(1)(J) from the provisions of section 12(d)(1)(A) and section
12(d)(1)(C), to permit the Applicants to effect the Proposed
Transactions.
    13. Sections 12(d)(1)(A) and 12(d)(1)(C) are made applicable to
BDCs by section 60 to the same extent as if they were registered
closed-end investment companies. The Proposed Transactions may be
viewed as violating sections 12(d)(1)(A) \4\ and 12(d)(1)(C) \5\
because prior to the Exchange, the Fund will own 100% of the newly
issued Shares of the Extension Fund, even

though such ownership will exist for only a momentary period of time.
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    \4\ Section 12(d)(1)(A) provides that no registered investment
company (``acquiring company'') may acquire securities of any other
investment company (``acquired company'') if such securities
represent more than 3% of the acquired company's outstanding voting
stock or more than 5% of the acquiring company's total assets, or if
such securities, together with the securities of other investment
companies, represent more than 10% of the acquiring company's total
assets.
    \5\ Section 12(d)(1)(C) provides that no investment company
(``acquiring company'') may acquire any securities issued by a
registered closed-end investment company, if the acquiring company
owns more than 10% of the total outstanding voting stock of such
closed-end company.
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    14. The Applicants submit that the requested exemption from
sections 12(d)(1)(A) and 12(d)(1)(C) meets the standards set forth in
section 12(d)(1)(J). Section 12(d)(1)(J) provides that ``the
Commission, by rule or regulation, upon its own motion or by order upon
application, may conditionally or unconditionally exempt any person,
security, or transaction, or any class or classes of persons,
securities, or transactions from any provision of this subsection, if
and to the extent that such exemption is consistent with the public
interest and the protection of investors.''
    15. The Applicants state that the Proposed Transactions are
consistent with the public interest in that they are intended to result
in a benefit to non-electing Unitholders, Electing Unitholders and
potential future investors in the Extension Fund. The Applicants also
state that the Proposed Transactions are consistent with investor
protection because the momentary holding by the Fund of Shares of the
Existing Fund does not raise any of the concerns that Sections
12(d)(1)(A) and (C) were intended to address.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-10246 Filed 5-14-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 62 (Thursday, March 31, 2022)]
[Notices]
[Pages 18853-18854]
[FR Doc No: 2022-06819]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2022-0418]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: Notice of
Landing Area Proposal

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The collection involves gathering information from airport
sponsors about any establishment, construction, alteration, or change
to the status or use of an airport. The FAA uses this information to
conduct airport airspace analyses to understand the impact of proposed
actions on existing and planned operating procedures, determine
potential hazardous effects, and identify any mitigating measures
needed to enhance safe air navigation. Additionally, the information
updates the aeronautical charts and maps of

airports having emergency landing or landmark values.

DATES: Written comments should be submitted by May 31, 2022.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Raymond Zee, Airport Data and Airspace Branch (AAS-120),
Office of Airport Safety and Standards, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591.
    By fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Raymond Zee by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0036.
    Title: Notice of Landing Area Proposal.
    Form Numbers: FAA Form 7480-1.
    Type of Review: Renewal of an information collection.
    Background: Title 14 Code of Federal Regulations Part 157, Notice
of Construction, Alteration, Activation, and Deactivation of Airports,
requires that each person who intends to establish, construct,
deactivate, or change the status of an airport, runway, or taxiway
notify the FAA of such activity. The FAA uses the information collected
to determine the effect the proposed action will have on existing
airports and on the safe and efficient use of airspace by aircraft, the
effects on existing airspace or contemplated traffic patterns of
neighboring airports, the effects on the existing airspace structure
and projected programs of the FAA, and the effects that existing or
proposed manmade objects (on file with the FAA) and natural objects
within the affected area will have on the airport proposal. This
information also updates aeronautical charts and maps of airports
having emergency landing or landmark values. The FAA collects this
information via an online reporting tool available on the FAA website
or via FAA Form 7480-1.
    Respondents: Approximately 645 applicants.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 1 hour.
    Estimated Total Annual Burden: 645 hours.

Raymond Zee,
Civil Engineer, Airport Data and Airspace Branch, Office of Airport
Safety and Standards.
[FR Doc. 2022-06819 Filed 3-30-22; 8:45 am]
BILLING CODE 4910-13-P