(number of volunteers)	Dermal UEb

(mg/day)	Inhalation UEb

(mg/day)	Conversion Ratioc 	Absorbed Daily Dosesd

(mg/kg/day)	MOEse

Dermal	Inhalation	Dermal

ST/IT

Target = 100	Inhalation

ST/IT/LT

Target = 1000

Occupational Handler

Chemical Operator (n=11)	9.81	0.0281	0.0427	0.060	0.00017	3,333	29,412

Occupational Post-application

Grader (n=13)	3.13	0.0295	0.0427	0.019	0.00018	10,526	27,778

Trim Saw (n=2)	1.38	0.061	0.0427	0.0084	0.00037	23,809	13,513

Millwright (n=3)	12.81	0.057	0.0427	0.078	0.00035	2,564	14,286

Clean-Up (n=6)	55.3	0.60	0.0427	0.337	0.0037	593	1,351

ST = 	Short-term duration; IT = Intermediate-term duration; and LT =
long-term

a.	The exposure scenario represents a worker wearing either long-sleeved
or short-sleeved shirts, cotton work trousers, and cotton glove
dosimeter gloves under chemical resistant gloves. Volunteers were
grouped according to tasks they conducted at the mill.

b.	Dermal and inhalation unit exposures are from Bestari et al (1999).
Refer to Table B-1 in Appendix B for the calculation of the dermal and
inhalation exposures. Inhalation exposure (mg/day) was calculated using
the following equation: air concentration ((g/m3) x inhalation rate (1.0
m3/hr) x sample duration (8 hr/day) x unit conversion (1 mg/1000 (g).
The inhalation rate is from USEPA, 1997a.

c.	Conversion Ratio = 34.18% Oxine-Copper / 80% DDAC

d.	Absorbed Daily dose (mg/kg/day) = exposure (mg/day) * conversion
ratio (0.427) * absorption factor (NA for dermal and 100% for
inhalation)/body weight (70 kg).

e.			MOE = NOAEL (mg/kg/day) / Daily dose [Where ST/IT (systemic) NOAEL
= 200 mg/kg/day for dermal and ST/IT/LT NOAEL = 5 mg/kg/day for
inhalation]. Target MOE is 100 for dermal exposure and 1000 for
inhalation exposure.

Diptank Operators

	Exposures to diptank operators were also assessed using surrogate data
from the DDAC study (Bestari et al., 1999). The diptank scenario
assessment was conducted differently than for the other job functions
because the concentration of DDAC in the diptank solution was provided.
Typical registered product use rates for dip treatments (dipping,
diptank, immersion) are at levels of 0.11% to 1.25% ai. Non-pressure dip
treatment of wood intended for ground contact is usually specified for
levels of 1.0% ai or more. The exposures were estimated based on the
maximum application rate for dipping treatment to control sapstain cited
on product labeling for EPA Reg. No. 3008-91 which is a 34.18 % ai
concentrate used to make water-based treatment solutions of up to 2.3%
ai [i.e., 1:15 v/v use dilution (0.0666) x 34.18 % ai in product = 2.3 %
ai].  Product labeling cites use of eye protection and rubber gloves as
PPE.

	The exposure data for diptank operators wearing gloves were converted
into “unit exposures” in terms of mg a.i. for each 1% of
concentration of the product. The calculation of the dermal and
inhalation unit exposures (2.99 and 0.046 mg/1% solution, respectively)
is presented in Table B-2 in Appendix B.  The air concentrations
presented in the DDAC study were converted to unit exposures using an
inhalation rate of 1.0 m3/hr (light activity) and sample duration of 8
hrs/day.

The following equations are used to estimate dermal and inhalation
handler exposure:

Daily Dose = DDAC UE x AI x AB

		BW

Where

DDAC UE	=	DDAC dermal unit exposure (mg/ 1% in solution);

AI		=	AI (2.3% ai in solution/day);

AB	=	Absorption factor (NA for dermal, 100% for inhalation); and

BW		=	Body weight (70 kg).

	Table 7.5 provides the short-term and the intermediate- and long-term
doses and MOEs for diptank operators. The dermal ST/IT MOE was 2.037
which is above the target MOE of 100 and therefore not of concern.  The
inhalation ST/IT/LT MOE exceeded the Agency target of 1,000, as 3,311,
and is also not of concern.  Therefore, a confirmatory inhalation
toxicity study is not warranted based on the results of this exposure
scenario.

Table 7.5.  Short-, Intermediate-, and Long-Term Exposures and MOEs for
Diptank Operator

Exposure Scenarioa

(number of replicates)	Dermal Unit Exposureb

(mg DDAC/1% solution)	Inhalation Unit Exposureb

(mg DDAC/1% solution)	App Rate

(% a.i. in solution/ day)c 	Absorbed Daily Dosesd

(mg/kg/day)	MOEse

Dermal	Inhalation	Dermal

ST/IT

Target MOE = 100	Inhalation

ST/IT/LT

Target MOE = 1000

Occupational Handler

Dipping, with gloves (n=7)

	2.99	0.046	2.3	0.0982	0.00151

2,037

	3,311

ST = 	Short-term duration;  IT =Intermediate-term duration; and LT =
long-term.

a. 	The exposure scenario represents a worker wearing long-sleeved
shirts, cotton work trousers, and gloves. Gloves were worn only when
near chemical, not when operating the diptank.

b.	Dermal and inhalation unit exposures are from DDAC study (MRID
455243-04). Refer to Table B-2 in Appendix B for the dermal and
inhalation unit exposure calculations. Inhalation exposure (mg) was
calculated using the following equation: Air concentration (mg/m3) x
Inhalation rate (1.0 m3/hr) x Sample Duration (8 hr).  The inhalation
rate is from USEPA, 1997a.

c.	The maximum application rate for sapstain control dip application
method is 2.3% ai solution (3008-91).

d.	Absorbed Daily dose (mg/kg/day) = unit exposure (mg/1% ai solution) *
percent active ingredient in solution (2.3) * absorption factor (NA for
dermal and 100% for inhalation) / body weight (70 kg).

e.			MOE = NOAEL (mg/kg/day) / Daily dose [Where ST/IT (systemic) NOAEL
= 200 mg/kg/day for dermal and ST/IT/LT NOAEL = 5 mg/kg/day for
inhalation]. Target MOE is 100 for dermal exposure and 1000 for
inhalation exposure.

Construction Workers

	Not enough data exists to estimate the amount of exposure associated
with construction workers who install treated wood.  In particular,
values for the transfer coefficient associated with a construction
worker handling the wood could not be determined. However, it is
believed that the construction worker using a trim saw will have larger
dermal and inhalation exposures than the installer, due to the amount of
sawdust generated and the greater amount of hand contact that would be
necessary to handle the wood when using a saw compared to installing the
wood.

7.4.2	Pressure Treatment Scenarios (Handler and Post-Application)

	Oxine-Copper wood preservatives may be used to treat wood and wood
products using pressurized application methods, specifically empty-cell
vacuum pressure techniques.  Pressure treatment solutions of solubilized
Oxine-Copper are predominantly oil or solvent-based. However, there are
a few water-borne products registered as well. Typical registered
product use rates for pressure treatment are at levels of 0.25% ai. The
maximum rate of application used in this assessment is 1% ai solution
based on product labeling for EPA Reg. Nos. 2829-135 and 2829-136 which
are 10% ai concentrates, and indicate that pressure treatment use
solutions of up to 1% ai can be made [i.e., 10% w/w use dilution (10) x
10% ai in product (0.10) = 1% ai].

	 Oxine-Copper is listed in the American Wood-Preservers’Association
(AWPA) Book of Standards for treatment of several softwood species used
in exposed, above-ground applications. AWPA has standardized oil-borne
treatments using solubilized Oxine-Copper in their AWPA Standard P8 for
oil-borne preservatives.  The minimum specified retention (as
Oxine-Copper active ingredient) for these applications is 0.32 kg/m3
(0.02 lb/ft3).

	Chemical-specific exposure data are not available on Oxine-Copper for
assessment of pressure treatment exposure.  Therefore, the assessment
relies on surrogate chromated copper arsenate (CCA) data (ACC, 2002) and
was based on the approach used in a previous Agency exposure assessment
(USEPA, 2003).

Surrogate Unit Exposure Data

	Dermal and inhalation exposures for pressure treatment uses are derived
from information in the exposure study sponsored by the American
Chemistry Council (2002) entitled “Assessment of Potential Inhalation
and Dermal Exposure Associated with Pressure Treatment of Wood with
Arsenical Wood Products” (ACC, 2002).  In this study, a treatment
solution of CCA was approximately 0.5 percent active ingredient.  The
CCA exposure monitoring study has been reviewed by the Agency and is
considered a valid surrogate source of data for pressure treatment
applications and is therefore used in estimating exposure to
Oxine-Copper.

small (5 ≤ n ≤ 15).

	The measured CCA dermal and inhalation exposure values were normalized
by the treatment solution concentration used at each of the 3 facilities
(i.e., unit exposure reported as µg arsenic/ppm treatment solution).
The normalization by treatment solution concentration was performed to
extrapolate the measured exposures in the CCA study (monitored at ~0.5%
ai solution) to the maximum Oxine-Copper treatment solution
concentration (1% ai solution).  Table 6.6 presents the dermal and
inhalation unit exposure values normalized to the treatment solution
concentration in ppm for (1) all sites, (2) treatment operator (TA
handler), (3) treatment assistant (TA handler), and (4) all
post-application job functions (TS, SO, LO, S, TB, TM).

	Note: The U.S. and Canadian sites indicate a 7x difference in the mean
dermal exposures (US site mean is 0.40 µg As/ppm compared to the
Canadian site mean of 2.84 µg As/ppm).  It is recommended that
additional analysis be performed to determine if the increased exposure
levels at the Canadian site can be attributed to differences in
site-specific engineering controls or facility design.

Table 7.6.  Dermal and Inhalation Exposure Values from a CCA Pressure
Treatment Study (Exposure Data used as Surrogate Unit Exposures for
Oxine-Copper Assessment)

Site	Treatment Solution  	Statistic	Dermal Unit Exposure

((g As/ppm)	Air

Concentrationb

((g As/m3/ppm)	Inhalation Unit Exposurec

((g As/ppm)

	%	ppma

All sites - All Data

(n = 64)	0.438 to 0.595	4,380 to 5,950	Average ± std	0.97 ± Unknown
0.00013 ± 0.00023	0.00104

	Median	0.36	0.00013	0.00104

	90th percentile	2.07	0.00077	0.00617

	Maximum	7.74	0.0011	0.00882

All sites - Handler Treatment Operator

(n = 15)	0.438 to 0.595	4,380 to 5,950	Average ± std	2.04 ± 2.68
0.00032 ± 0.00038	0.00257

	Median	0.37	0.00013	0.00104

	90th percentile	5.39	0.00092	0.00737

	Maximum	7.74	0.0011	0.00882

All sites - Handler Treatment Assistant

(n = 10)	0.438 to 0.595	4,380 to 5,950	Average ± std	0.24 ± 0.14
0.0001 ± 0.00004	0.000802

	Median	0.23	0.00013	0.00104

	90th percentile	0.40	0.00013	0.00104

	Maximum	0.52	0.00014	0.00112

All sites – Post-application: All job functions (TS, SO, LO, S, TB,
TM)

(n = 39)	--	--	Average ± std	0.74 ± 0.73	0.00020 ± 0.00025	0.00160

	Median	0.42	0.00013	0.00104

	90th percentile	1.81	0.00050	0.00401

	Maximum	3.11	0.0011	0.00882

	a.	ppm = (% treatment solution) * (10,000).

	b.	Air concentration was calculated as (g collected per sample per ppm
/ (480 min per day x 2 L/min).

	c.	Inhalation unit exposure = air concentration ((g As/m3/ppm) *
breathing rate for light activities (0.0167 	m3/min) * sample duration
(480 min).  Values shown in bold are used for the assessment.

Exposure Calculations

The following equation was used to estimate dermal and inhalation
handler exposure:

Absorbed Daily Dose = 	UE x AI x AB

	      	       BW

Where

UE	=	Unit exposure (mg As/ppm);

AI	=	Percent active ingredient (1% ai in solution);

AB	=	Absorption factor (Not applicable [NA] for dermal, 100% for
inhalation); and

BW	=	Body weight (70 kg).

Results

	The estimated dermal and inhalation exposures and risks for
Oxine-Copper pressure treatment uses are presented in Table 7.7.  The
calculated ST/IT dermal MOEs are all above the target MOE of 100 and do
not pose a risk concern.  Also, the inhalation ST/IT/LT MOEs for all
scenarios and durations are above the target MOE of 1000, therefore, a
confirmatory inhalation toxicity study is not warranted based on the
screening-level results.

Table 7.7.  Short-, Intermediate-, and Long-Term Exposures and MOEs for
Pressure Treatment Handler and Post-application Scenarios Related to
Oxine-Copper Use

Exposure Scenarioa

Unit Exposurea

((g As/ppm)

Application Rate

(% ai solution) 	Absorbed Daily Dosesb

(mg/kg/day)	MOEsc

	Dermal	Inhalation

Dermal	Inhalation	Dermal

ST/IT

Target = 100	Inhalation

ST/IT/LT

Target=1000

Occupational Handler

Treatment Operator (TO)	2.04	0.00257	1	0.291	0.000367	687	13,624

Treatment Assistant (TA)	0.24	0.000802	1	0.0343	0.000115	5,831	43,478

Occupational Post-application

All Job Functions

(Tram setter, stacker operator, loader operator, supervisor, test borer,
and tallyman) 	0.74	0.00160	1	0.106	0.000229	1,887	21,834

ST = 	Short-term duration; IT = Intermediate-term duration; and LT =
long-term.

a. 	Unit exposure values are taken from CCA study as shown above and in
Table 6.6.

μg) * absorption factor (NA for dermal; 100% for inhalation) / Body
weight (70 kg).

c.			MOE = NOAEL (mg/kg/day) / Daily dose [Where ST/IT (systemic) NOAEL
= 200 mg/kg/day for dermal and ST/IT/LT NOAEL = 5 mg/kg/day for
inhalation]. Target MOE is 100 for dermal exposure and 1000 for
inhalation exposure.

	7.5	Data Limitations/Uncertainties tc \l2 "6.3	Data
Limitations/Uncertainties

	There are several data limitations and uncertainties associated with
the occupational handler and post-application exposure assessments.
These include:

Surrogate dermal and inhalation unit exposure values were taken from the
proprietary Chemical Manufacturers Association (CMA) antimicrobial
exposure study (USEPA, 1999: DP Barcode D247642) or from the Pesticide
Handlers Exposure Database (USEPA, 1998) (See Appendix A for summaries
of these data sources).   Since the CMA data are of poor quality, the
Agency may request that confirmatory data be submitted in order to
support the occupational scenarios assessed in this document.

The low pressure spray unit exposure data from PHED were used to assess
both outdoor environmental surface treatments (materials preservative)
and applications of wood coatings/water repellents (wood preservatives).
 As the low pressure spray data are representative of treating low to
mid level range targets (shrubs/greenhouse benches) and the scenarios
assessed in this document represents treatments that may also occur
above the waist, the unit exposure value may underestimate exposure to
the head and the upper body.

For the wood preservative pressure treatment scenarios, surrogate CCA
exposure data were used for lack of chemical-specific exposure data for
this use pattern. For the wood preservative non-pressure treatment
scenarios, surrogate DDAC exposure data were used for the lack of
chemical-specific exposure data.  Limitations and uncertainties
associated with the use of these data include:

The assumption was made that exposure patterns for workers at treatment
facilities using CCA and DDAC would be similar to exposure patterns for
workers at treatment facilities using Oxine-Copper, and therefore the
exposures could be used as surrogate data for workers that treat wood
with Oxine-Copper based formulations.

For environmental modeling, it was assumed that the leaching process
from wood treated with Oxine-Copper would be similar to that of CCA and
DDAC. However, due to the lack of robust data for Oxine-Copper -treated
wood, it is not possible to verify this assumption.

The quantities handled/treated were estimated based on information from
various sources, including Agency standard assumptions, HED’s Standard
Operating Procedures (SOPs) for Residential Exposure Assessments (USEPA,
2000 and 2001), and professional judgment based on Agency understanding
of industrial practices.  In certain cases, no standard values were
available for some scenarios.  Assumptions for these scenarios were
based on AD estimates and could be further refined with input from
registrants.

8.0	ENVIRONMENTAL RISKS

8.1	Ecological Hazard

	8.1.1	Toxicity to Terrestrial Animals

		<IP_ADDRESS>   Birds, Acute

		In order to establish the toxicity of copper-8 to avian species, the
Agency requires an acute oral toxicity study using the technical grade
active ingredient (TGAI).  The preferred test species is either mallard
duck (a waterfowl) or bobwhite quail (an upland game bird).  The results
of two acute oral toxicity studies, submitted for copper-8, are provided
in the following table (Table 8.1).

Table 8.1.  Acute Oral Toxicity of Copper-8-Quinolinolate to Birds

Species

Chemical,

% Active Ingredient

(a.i.)

Tested

Endpoint

(mg/kg)

Toxicity Category

Satisfies Guidelines/

Comments

Reference

(MRID No.)

Bobwhite quail

(Colinus virginianus)	Copper-8 99.5%	LD50 = 618

	Slightly toxic	Yes (core)

- 14-day test duration

- 4-5 months of age	42927101

Mallard duck

(Anas platyrhynchos)	Copper-8 99.5%	LD50 = >2000

NOAEL = 2000

	Relatively nontoxic	Yes (core)

- 14-day test duration

- 15 months of age	42927102

		These acceptable acute oral toxicity studies indicate that copper-8 is
slightly toxic to relatively nontoxic to birds on an acute oral basis.
The guideline requirement OPPTS 850.2100/ (71-1) is satisfied.

			<IP_ADDRESS>   Birds, Subacute

		A subacute dietary study using the TGAI may be required on a
case-by-case basis depending on the results of lower-tier ecological
studies and pertinent environmental fate characteristics in order to
establish the toxicity of a chemical to avian species.  This testing was
required for copper-8.  The preferred test species is either the mallard
duck or bobwhite quail.  The results of two subacute dietary toxicity
studies, submitted for copper-8, are provided in the following table
(Table 8.2).

Table 8.2.  Subacute Oral Toxicity of Copper-8 to Birds

Species

Chemical,

% Active Ingredient

(a.i.)

Tested

Endpoint

(ppm)

Toxicity Category

Satisfies Guidelines/

Comments

Reference

(MRID No.)

Bobwhite quail

(Colinus virginianus)	Copper-8 99.5%	LC50 (diet) = 3248

NOAEC = 1300	Slightly toxic	Yes (core)

-	8-day test duration

-	14 days of age	42927103

Mallard duck

(Anas platyrhynchos)	Copper-8 99.5%	LC50 (diet) = >5200

NOAEC = 2600	Relatively nontoxic	Yes (core)

-	8-day test duration

-  10 days of age	42927104

		The results from these acceptable studies indicate that copper-8 is
slightly toxic to relatively nontoxic to avian species through subacute
dietary exposure. These studies fulfill guideline requirements OPPTS
850.2100/ (71-2a – Bobwhite quail and 71-2b – Mallard duck).

	<IP_ADDRESS>   Mammals, Acute and Chronic Toxicity

Wild mammal testing is not required by the Agency.  In most cases, rat
toxicity values obtained from studies conducted to support data
requirements for human health risk assessments substitute for wild
mammal testing.  Refer to the human toxicology chapter of this RED for
mammalian toxicity data.

		8.1.2	Toxicity to Aquatic Animals

			<IP_ADDRESS>   Freshwater Fish, Acute

		In order to establish the acute toxicity of copper-8 to freshwater
fish, the Agency requires freshwater fish toxicity studies using the
TGAI.  The preferred test species are rainbow trout (a coldwater fish)
and bluegill sunfish (a warmwater fish).  The results of four freshwater
fish acute studies submitted for copper-8, 3 coldwater and 1 warmwater,
are presented in Table 8.3.

Table 8.3.  Acute Toxicity of Copper-8 to Freshwater Fish

Species

Chemical,

% Active Ingredient

(a.i.)

Tested

Endpoint

(mg/L)

Toxicity Category

Satisfies Guidelines/

Comments

Reference

(MRID No.)

Bluegill Sunfish (Lepomis macrochirus)	Copper-8 100%	LC50 = 0.0216

NOAEC = 0.0108	Very highly toxic	Yes (core)

-	96-hr test duration

-	flow-through test system	42899003

Rainbow Trout (Oncorhynchus mykiss)	Copper-8 100%	LC50 = 0.0089

NOEC = 0.0062	Very highly toxic	Yes (core)

- 96-hr test duration

- flow-through test system	42899002

Rainbow Trout (Oncorhynchus mykiss)	Copper-8 80%	LC50 = 0.0097

NOAEC = 0.0071	Very highly toxic	Yes (core)

- 96-hr test duration

- static renewal test system	43563701

Coho Salmon (Oncorhynchus kisutch)	Copper-8 100%	LC50 = 0.0139

NOAEC = 0.0066	Very highly toxic	Yes (core)

- 96-hr test duration

- flow-through test system	42902401

		Freshwater acute toxicity tests indicate that copper-8 is very highly
toxic to the coldwater rainbow trout and very highly toxic to the
warmwater bluegill sunfish on an acute basis.  Guideline requirement
OPPTS 850.1075 (72-1a&b) is fulfilled.  Because acute toxicity to fish
is <1.0 mg/L the environmental hazard section of copper 8 labels must
state: “This pesticide is toxic to fish.”

		<IP_ADDRESS>   Freshwater Invertebrates, Acute

		The Agency requires a freshwater aquatic invertebrate study using the
TGAI to establish the acute toxicity to freshwater invertebrates.  The
preferred test species is Daphnia magna.  The results of one study
submitted for copper-8 is provided in the following table (Table 8.4).

Table 8.4.  Acute Toxicity of Copper-8 to Freshwater Invertebrates

Species

Chemical,

% Active Ingredient

(a.i.)

Tested

Endpoint

(mg/L)

Toxicity Category

Satisfies Guidelines/

Comments

Reference

(MRID No.)

Waterflea (Daphnia magna)	Copper-8

98%	EC50 = 0.162

NOAEC = < 0.036 	Highly toxic	Yes (core)

-	48-hr test duration

-	flow-through test system 	43228401

		The results of MRID 432284-01 indicate that copper-8 is highly toxic
to freshwater invertebrates. This study fulfills guideline requirement
OPPTS 850.1010 (72.2a). Because the acute aquatic invertebrate toxicity
value is < 1.0 mg/L, the environmental hazard section of copper-8 labels
must state: “This pesticide is toxic to aquatic invertebrates.

			<IP_ADDRESS>   Estuarine and Marine Organisms, Acute

		Acute toxicity testing with estuarine and marine organisms using the
TGAI is required when the end-use product is intended for direct
application to the marine/estuarine environment or effluent containing
the active ingredient is expected to reach this environment.  The
preferred fish test species is the sheepshead minnow.  The preferred
invertebrate test species are mysid shrimp and eastern oysters.  This
testing is required for copper-8 based on the chemical’s potential to
reach estuarine and marine environments.  The results of two toxicity
studies submitted for copper-8 are presented in Table 8.5.

Table 8.5.  Acute Toxicity of Copper-8 to Estuarine and Marine Organisms

Species

Chemical,

% Active Ingredient

(a.i.)

Tested

Endpoint

(mg/L)

Toxicity Category

Satisfies Guidelines/

Comments

Reference

(MRID No.)

Eastern oyster (Crassostrea virginica)	Copper 8

100%	LC50  = 0.0363

EC50 = 0.0111

NOAEC = 0.003	Very highly toxic	Yes (core)

-	48-hr test duration

-	static test system	42899004

		The results of the one core study indicate that copper-8 is very
highly toxic to estuarine/marine invertebrates on an acute basis.  The
Eastern oyster study (42899004) fulfills the guideline requirement OPPTS
850.1025/ (72-3b) for an acute estuarine/marine mollusk study. Study
MRID 42902402 for Mysid shrimp is INVALID and must be repeated.  The
guideline requirements OPPTS 850.1075/ (72-3a) for an acute
estuarine/marine fish study and OPPTS 850.1035/ (72-3c) for an
estuarine/marine shrimp study are not fulfilled.  Because
estuarine/marine acute toxicity values are < 1.0 mg/L, the environmental
hazard section of copper-8 labels must state:  “This pesticide is
toxic to oysters and shrimp.”

		<IP_ADDRESS>   Aquatic Organisms, Chronic

		Chronic toxicity testing (fish early life stage and aquatic
invertebrate life cycle) is required for pesticides when certain
conditions of use and environmental fate apply.  Preferred freshwater
and estuarine/marine fish and invertebrate species include:  fathead
minnow, rainbow trout, Daphnia magna, and mysid shrimp.  Two studies
were submitted for copper-8, but are INVALID and must be repeated.  The
rainbow trout study (42902403) does not fulfill the guideline
requirement for a fish early life stage toxicity test (72-4a/OPPTS
850.1400) due to the percent RSD of weight in one replicate of the
solvent control being >40%. The study on the waterflea (42899005) also
does not fulfill the guideline requirement for a chronic aquatic
invertebrate because dissolved oxygen concentrations fell to extremely
low levels during the test and the highest measured concentration in one
exposure solution was greater than twice the lowest measured
concentration at the same level.

		8.1.3	Toxicity to Plants

		Non-target plant phytotoxicity testing is required for pesticides when
certain conditions of use and environmental fate apply.  The use of
copper-8 as a wood treatment may result in chemical leachate from
treated wood into the aquatic environment.  Aquatic plant toxicity data
are necessary for a non-target plant risk assessment.  Testing is
conducted with one species of aquatic vascular plant (Lemna gibba) and
four species of algae:  (1) freshwater green alga, Selenastrum
capricornutum, (2) marine diatom, Skeletonema costatum, (3) freshwater
diatom, Navicula pelliculosa, and (4) bluegreen cyanobacteria, Anabaena
flos-aquae.  The rooted aquatic macrophyte rice (Oryza sativa) is also
tested in seedling emergence and vegetative vigor tests.

		Two marine diatom studies and a saltwater green algae study were
reviewed. Results of these studies are presented in Table 8.6.

Table 8.6.  Toxicity of Copper-8 to Aquatic Plants

Species

Chemical,

% Active Ingredient

(a.i.)

Tested

Endpoint

(mg/L)

Satisfies Guidelines/

Comments

Reference

(MRID No.)

Marine diatom (Nitzschia punctata)	Copper-8

100%	EC50 = 0.0073	No (supplemental)

- 5-day test duration

-  static test system

-  NOEC not determined	42902404

Marine diatom (Skeletonema costatum)	Copper-8

98%	EC50 = 0.0019

NOEC = < 0.0007	Yes (core)

- 5-day test duration

- static test system

	43073501

Saltwater Green alga (Dunaliella tertiolecta)	Copper-8

100%	EC50 = 0.0154

NOEC = 0.009	Yes (core)

- 5-day test duration

- static test system 	42902405

		The studies above are classified as acceptable and partially fulfill
the guideline requirements for an algae toxicity test (850.5400, 123-2).
 Three additional algal toxicity tests under 850.5400 are outstanding:
freshwater diatom (Navicula pelliculosa), blue-green cyanobacteria
(Anabeana flos-aquae), and freshwater green alga (Selenastrum
capricornutum).  Other outstanding non-target aquatic plant toxicity
tests are:  floating freshwater aquatic macrophyte duckweed (Lemna
gibba) – 850.4400 and rooted freshwater macrophyte rice (Oryza sativa)
– 850.4225 and 850.4250 (2 tests on seedling emergence and vegetative
vigor).

		8.1.4	RISK QUOTIENTS

Risk assessment integrates the results of the exposure and ecotoxicity
data to evaluate the likelihood of adverse ecological effects. One
method of integrating the results of exposure and ecotoxicity data is
called the quotient method.  For this method, risk quotients (RQs) are
calculated by dividing exposure estimates by ecotoxicity values, both
acute and chronic:

           RQ = EXPOSURE/TOXICITY

RQs are then compared to levels of concern (LOCs).  These LOCs are
criteria used by OPP to indicate potential risk to nontarget organisms
and the need to consider regulatory action.  The criteria indicate that
a pesticide used as directed has the potential to cause adverse effects
on nontarget organisms.  LOCs currently address the following risk
presumption categories: (1) acute - the potential for acute risk is
high, regulatory action may be warranted in addition to restricted use
classification; (2) acute restricted use - the potential for acute risk
is high, but this may be mitigated through restricted use
classification; (3) acute endangered species - the potential for acute
risk to endangered species is high, and regulatory action may be
warranted, and (4) chronic risk - the potential for chronic risk is
high, and regulatory action may be warranted, (5) non-endangered plant
risk – potential for effects in non-target plants, and (6) endangered
plant risk – potential for effects in endangered plants.   Currently,
EPA does not perform assessments for chronic risk to plants, acute or
chronic risks to nontarget insects, or chronic risk from granular/bait
formulations to birds or mammals.

The ecotoxicity test values (measurement endpoints) used in the acute
and chronic risk quotients are derived from required studies.  Examples
of ecotoxicity values derived from short-term laboratory studies that
assess acute effects are: (1) LC50 (fish and birds), (2) LD50 (birds and
mammals), (3) EC50 (aquatic plants and aquatic invertebrates) and (4)
EC25 (terrestrial plants).  Examples of toxicity test effect levels
derived from the results of long-term laboratory studies that assess
chronic effects are: (1) LOAEC (birds, fish, and aquatic invertebrates),
and (2) NOAEC (birds, fish and aquatic invertebrates). For birds and
mammals, the NOAEC generally is used as the ecotoxicity test value in
assessing chronic effects, although other values may be used when
justified. However, the NOAEC is used if the measurement endpoint is
production of offspring or survival.  Risk presumptions, along with the
corresponding RQs and LOCs are tabulated below.

Risk Presumptions for Terrestrial Animals

Risk Presumption

RQ

LOC

Birds and Wild Mammals

Acute Risk

EEC1/LC50 or LD50/sqft2 or LD50/day3

0.5

Acute Restricted Use

EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)

0.2

Acute Endangered Species

EEC/LC50 or LD50/sqft or LD50/day

0.1

Chronic Risk

EEC/NOAEC

1

 1  abbreviation for Estimated Environmental Concentration (ppm) on
avian/mammalian food items

 2    mg/ft2             	3  mg of toxicant consumed/day

   LD50 * wt. of bird             	LD50 * wt. of bird

Risk Presumptions for Aquatic Animals

Risk Presumption

RQ

LOC

Acute Risk

EEC1/LC50 or EC50

0.5

Acute Restricted Use

EEC/LC50 or EC50

0.1

Acute Endangered Species

EEC/LC50 or EC50

0.05

Chronic Risk

EEC/MATC2 or NOAEC

1

 1  EEC = (ppm or ppb) in water

 2  MATC = maximum allowable toxicant concentration

Risk Presumptions for Plants

Risk Presumption

RQ

LOC

Terrestrial and Semi-Aquatic Plants

Acute Risk

EEC/EC25

1

Acute Endangered Species

EEC/EC05 or NOAEC

1

Aquatic Plants

Acute Risk

EEC1/EC50

1

Acute Endangered Species

EEC/EC05 or NOAEC

1

EEC = (ppb/ppm) in water

Maximum Expected Environmental Concentrations:

	EPA calculated the leaching of copper-8 from a dock into water.  It was
assumed that 4% of the total applied copper-8 would leach from the wood
into the water.  The retention rate of the wood was assumed to be 22
(g/cm2.  The length and width of the dock was assumed to be 30 meters
and 10 meters, respectively and the thickness of the wood was assumed to
be 0.1 meters.  The number of poles underneath the dock was assumed to
be 18 and the dimensions of the poles were assumed to be 2 meters
(length) x 0.15 meters (width) x 0.15 meters (height).  The poles were
assumed to be 0.5 meters inserted into the sediment.  Based on these
specifications, copper-8 EECs were calculated for water body sizes
ranging from 1 acre foot to 24 acre feet.  The highest EEC calculated
for the smallest body of water (1 acre foot) was 0.00226 mg copper-8 per
liter of water.  The calculated EEC for a slightly larger body of water
(6 acre feet) is 0.00038 mg copper-8 per liter of water.  For details on
the calculations conducted to arrive at this EEC as well as the
uncertainties and limitations of the calculations, consult Siroos
Mostaghimi’s 4/25/2007 memo “Estimated Environmental Concentrations
for Copper 8-Quinolinolate (Cu8Q) from Treated Wood Used to Build
Docks.”

Maximum Ecotoxicity Values:

From the toxicity tables in section 8.1 above, the highest toxicity in
an acceptable fish study was achieved in a study on the rainbow trout
(Oncorhynchus mykiss).  The LC50 value obtained in this study was 0.0089
mg/L (MRID 42899002).  The EC50 value obtained in the study on the
freshwater invertebrate (Daphnia magna) was 0.162 mg/L (MRID 43228401).
The EC50 value obtained in the study on the eastern oyster (Crassostrea
virginica) was 0.0111 mg/L (MRID 42899004).  There were no acceptable
acute toxicity studies for estuarine and marine fish or shrimp nor were
there any acceptable chronic toxicity studies available for aquatic
organisms.  Therefore, risk to these species cannot be assessed.  The
highest toxicity in an acceptable aquatic plant toxicity study was
achieved in a study on the marine diatom (Skeletonema costatum).  The
EC50 value obtained in this study was 0.0019 mg/L and the NOEC was <
0.0007 (MRID 43073501).   Due to outstanding plant toxicity studies, the
non-target plant risk assessment is incomplete.

Acute Freshwater Fish LOC’s:

Comparing the maximum calculated EEC (0.00226 mg/L) to the highest
toxicity found in a fish acute study (0.0089 mg/L), an RQ of 0.254 is
obtained.  This is less than the LOCs for acute and chronic risks to
aquatic animals but greater than the LOCs for endangered species and
acute restricted use.  Therefore, there is the potential for copper-8 to
cause adverse effects to endangered freshwater fish and these risks may
need to be mitigated.  The calculated EEC for a slightly larger body of
water (6 acre feet) is 0.00038 mg copper-8 per liter of water.  This EEC
brings the RQ for freshwater fish down to 0.043, therefore the risk to
endangered fish species is no longer considered significant in this size
body of water.  However, as discussed below an endangered species effect
determination will not be made at this time.

Acute Freshwater Aquatic Invertebrate LOC’s:

Comparing the maximum calculated EEC to the toxicity value found in the
study on the freshwater invertebrate (0.162 mg/L), an RQ of 0.014 is
obtained.  This is less than all LOCs for aquatic organisms, therefore
the potential for risks from copper-8 to aquatic invertebrates is not
high.  The calculated EEC for a slightly larger body of water (6 acre
feet) is 0.00038 mg copper 8 per liter of water.  The calculated RQ is
less than 0.00 and therefore no risk is triggered for a larger water
body.  However, as discussed below an endangered species effect
determination will not be made at this time.

Acute Aquatic Estuarine/Marine Species:

For the eastern oyster, the RQ is 0.204.  This is less than the LOCs for
acute and chronic risks to aquatic animals but greater than the LOCs for
endangered species and acute restricted use.  Therefore, there is the
potential for copper-8 to cause adverse effects to endangered estuarine
and marine organisms and these risks may need to be mitigated.  The
calculated EEC for a slightly larger body of water (6 acre feet) is
0.00038 mg copper-8 per liter of water.  This EEC brings the RQ for the
eastern oyster down to 0.034 and the RQ for aquatic plants down to 0.2
so the risks to endangered estuarine/marine organisms and aquatic plants
are no longer considered significant either.  This risk assessment is
incomplete due to outstanding fish and shrimp toxicity studies.

Chronic Aquatic Toxicity Studies:

	Chronic freshwater fish and invertebrate studies are triggered based on
acute toxicity.  No valid studies are available for copper-8.
Estuarine/marine chronic toxicity studies for fish and invertebrates are
required.  This risk assessment is incomplete.

Plant Toxicity Studies:

Comparing the maximum calculated EEC (0.00226 mg/L) to the highest
toxicity value found for aquatic plants (0.0019 mg/L), an RQ of 1.189 is
obtained. This is greater than the LOC of >1.0 and therefore there is
the potential for acute risk to aquatic plants, including endangered
species, from copper-8. The calculated EEC for a slightly larger body of
water (6 acre feet) is 0.00038 mg copper-8 per liter of water. This EEC
brings the RQ for aquatic plants down to 0.2 so the risks to endangered
estuarine/marine organisms and aquatic plants are no longer considered
significant for the larger body of water. This risk assessment is
incomplete due to outstanding plant toxicity studies.

Avian and Mammalian Species:

Based on available avian toxicity data for copper-8, the various wood
treatments are not expected to be acutely toxic.

	8.2	Environmental Fate Assessment

	Copper 8-quinolinolate is hydrolytically stable at pH 5, 7 and 9 but
photolytically it is not stable. More than 80% of it is stable in
aerobic and anaerobic soils. In aerobic soils its half-life is about
four months, but it may be over one year in anaerobic soils.  It does
not show any tendency to migrate from top soil. It is therefore likely
to contaminate surface water through surface water run-off. Its
degradation pathway appears to be aqueous photolysis with a half-life of
60 to 96 hours. Leaching from (sapstain use) treated Douglas fir wood is
666 mg/1000 board feet while for Hemlock it is 229 mg/1000 board feet
after 8 stimulated rain cycles. The estimated log Kow for copper
8-quinolinolate is 2.5, which indicates that it is not likely to
bioaccumulate in aquatic organisms like fish. It is persistent in water
and soils.

8.3	Environmental Exposure and Ecological Risk Assessment

	LOCs were not exceeded for fish, freshwater invertebrates, the eastern
oyster or aquatic plants in bodies of water 6 acre feet in size or
greater, whereas risks to endangered freshwater fish and the eastern
oyster as well as risks to aquatic plants were of concern in bodies of
water 1 acre foot in size or less.  Since it is unlikely that a dock of
the size used in the calculations for EEC will be present on a body of
water less than 6 acre feet in size, the risks to aquatic organisms from
copper 8 in this assessment appear to be small. There were no acceptable
acute toxicity studies for other estuarine and marine organisms nor were
there any acceptable chronic toxicity studies available for aquatic
organisms. Therefore, risk to these species could not be assessed.

8.4	Endangered Species Considerations

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2),
requires all federal agencies to consult with the National Marine
Fisheries Service (NMFS) for marine and anadromous listed species, or
the United States Fish and Wildlife Services (FWS) for listed wildlife
and freshwater organisms, if they are proposing an "action" that may
affect listed species or their designated habitat.  Each federal agency
is required under the Act to insure that any action they authorize,
fund, or carry out is not likely to jeopardize the continued existence
of a listed species or result in the destruction or adverse modification
of designated critical habitat.  To jeopardize the continued existence
of a listed species means "to engage in an action that reasonably would
be expected, directly or indirectly, to reduce appreciably the
likelihood of both the survival and recovery of a listed species in the
wild by reducing the reproduction, numbers, or distribution of the
species." 50 C.F.R. ( 402.02.

To facilitate compliance with the requirements of the Endangered Species
Act subsection (a)(2) the Environmental Protection Agency, Office of
Pesticide Programs has established procedures to evaluate whether a
proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed
species in the wild by reducing the reproduction, numbers, or
distribution of any listed species (U.S. EPA 2004).  After the
Agency’s screening-level risk assessment is performed, if any of the
Agency’s Listed Species LOC Criteria are exceeded for either direct or
indirect effects, a determination is made to identify if any listed or
candidate species may co-occur in the area of the proposed pesticide
use.  If determined that listed or candidate species may be present in
the proposed use areas, further biological assessment is undertaken.
The extent to which listed species may be at risk then determines the
need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.

For certain use categories, the Agency assumes there will be minimal
environmental exposure, and only a minimal toxicity data set is required
(Overview of the Ecological Risk Assessment Process in the Office of
Pesticide Programs U.S. Environmental Protection Agency - Endangered and
Threatened Species Effects Determinations, 1/23/04, Appendix A, Section
IIB, pg.81).  Chemicals in these categories therefore do not undergo a
full screening-level risk assessment, and are considered to fall under a
“No Effect” determination.  The materials preservative uses of
copper 8-quinolinolate fall into this category.

	The preliminary analysis for wood treatment uses indicates that there
is a potential for copper-8 use to overlap with listed species and that
a more refined assessment is warranted, to include direct, indirect and
habitat effects.  The more refined assessment should involve clear
delineation of the action area associated with proposed use of copper 8
and best available information on the temporal and spatial co-location
of listed species with respect to the action area.  This analysis has
not been conducted for this assessment.  An endangered species effect
determination will not be made at this time.  The wood runoff label
statement is expected to provide some level of mitigation until such
time as a full endangered species assessment is possible.

8.5	Data Uncertainties and Limitations

	Fate and Environmental Modeling: There are a number of uncertainties
and limitations with this preliminary environmental risk assessment.
Extrapolating risk conclusions from the pond scenario used in the
environmental modeling may either underestimate or overestimate
potential exposures and risks. Numerous uncertainties exist with the
modeling used since environmental properties are likely to be regionally
specific because of local hydrogeological conditions. Further, any
alteration in water quality parameters may impact the environmental
behavior of the pesticide.  Additionally, there are pertinent data (wood
leaching) lacking; such data would be useful in refining this
preliminary risk assessment.

	Eco-Toxicity Data:  This screening level risk assessment relies on
selected toxicity endpoints from, what is believed to be, the most
sensitive species tested, but it does not necessarily mean that the
selected toxicity endpoints reflect sensitivity of the most sensitive
species existing in a given environment. Surrogates were used to predict
potential risks for various species, and data for several species are
lacking. Submission of additional non-target organism data will refine
this screening level assessment.

	Stakeholder Modeling Efforts:  The American Chemistry Council (ACC)
Biocides Panel Copper Reregistration Task Force is presently developing
modeling pertinent to the wood preservative and roofing uses of various
copper products. This modeling effort is intended to provide estimated
environmental exposures which can be used by the Agency to refine
environmental assessments. Such data would be useful in refining this
screening level assessment.

Confirmatory data listed below is required to support the wood treatment
use of

copper-8-quinolinolate:

Estuarine/marine fish acute study (850.1075),

Estuarine/marine shrimp acute study (850.1035),

Acute sediment toxicity to freshwater invertebrates (850.1735),

Acute sediment toxicity to estuarine invertebrates (850.1740),

Aquatic invertebrate (freshwater) life-cycle study (850.1300),

Fish early life-stage (freshwater) study (850.1400),1

Fish early life-stage (estuarine/marine) study (850.1400),1

Chronic mysid shrimp study (850.1350),1

Freshwater diatom (850.5400),

Blue-green cyanobacteria (850.5400),

Freshwater green alga (850.5400),

Freshwater floating macrophyte duckweed (850.4400),

Freshwater rooted macrophyte rice seedling emergence (850.4225),

Freshwater rooted macrophyte rice vegetative vigor (850.4250),

Wood leaching study (AWPA E11-06),

Environmental runoff monitoring study (None).  This test can be waived
provided labels are amended as outlined below for wood preservative
labels,

Residues in honey/beeswax and toxicity of treated wood residues to bees
– combination of Guideline 860.1500 and 850.3030 (“Honey Bee
Toxicity of Residues on Foliage.”).  The toxicity portion of this
study is in lieu of the honeybee contact LD50 test 850.3020.  The
residue and toxicity test can be waived provided the label is amended to
prohibit the use of treated wood for beehive construction, with a
statement such as, “Wood treated with copper 8-quinolinolate shall not
be used in the construction of beehives.”

9.0	INCIDENT REPORTS

The Agency reviewed the following information for human poisoning
incidents related to copper-8-quinolinolate use: (1) OPP Incident Data
System (IDS) – The Office of Pesticides Programs (OPP) Incident Data
System contains reports of incidents from various sources, including
registrants, other federal and state health and environmental agencies
and individual consumers, submitted to OPP since 1992; (2) California
Department of Pesticide Regulation (1982-2004) - The California
Department of Pesticide Regulation pesticide poisoning surveillance
program consists of reports from physicians of illness suspected of
being related to pesticide exposure since 1982. (3) National Pesticide
Information Center (NPIC) – NPIC is a toll-free information service
supported by OPP that provides a ranking of the top 200 active
ingredients for which telephone calls were received during calendar
years 1984-1991. (4) National Poison Control Centers (PCC) (1993-1996).

Eight definite or probable relationship cases submitted to the
California Pesticide Illness Surveillance Program (1982-2004) were
reviewed and all the symptoms were irritation type reactions. Dermal and
eye exposure are the primary routes of exposure associated with these
incidences. For eye contact, red, itchy eyes, blurred vision,
photophobia, chemical conjunctivitis, cornea abrasions have been
reported.  For dermal contact, red, rash and contact dermatitis have
been reported. For inhalation exposure, sore and burning throat, and
inhalation infection symptoms have been reported. There was no incidence
requiring hospitalization and no severe incidences associated with
copper-8-exposure have been reported.

10.0	REFERENCES

Toxicology References

00083777	Mulligan, T.; Banas, D.A. (1976). Final Report: Two-year
Dietary Administration in the Rat: Project No. 854-104. (Unpublished
study received May 20, 1981 under 42567-1; prepared by Hazleton
Laboratories America, Inc., submitted by La Quinoleine S.A., c/o Regst.
Consulting, Pacifica, Calif.; CDL: 245397-G).

00099606	Mulligan, T.; Voelker, R. (1976). Final Report: Two-year
Dietary Toxicity Study in Dogs: Project No. 854-103. (Unpublished study
received Dec 8, 1978 under 42567-1; prepared by Hazleton Labo- ratories
America, Inc., submitted by La Quinoleine S.A., c/o Registration
Consulting Associates, Pacifica, CA; CDL:237444-A).

 0079233	Mulligan, T.; Durloo, R. (1975). Final Report: A Two Generation
Reproduction Study in Rats: Project No. 854-105. (Unpublished study
received May 20, 1981 under 42567-1; prepared by Hazleton Laboratories
America, Inc., submitted by La Quinoleine S.A., c/o Regst. Consulting,
Pacifica, Calif.; CDL: 245397-F).

41063701	Ridgway, P. (1987). K37 (Copper 8-Hydroxyquinolate): rabbit
teratology dose ranging study: Project ID: AKJ/5/87. Unpublished study
prepared by Toxicol Laboratories Ltd.

41063702	 Ridgway, P. (1987). K37 (Copper 8-Hydroxyquinolate): Rabbit
Teratology Study: Project ID: AKJ/6/87. Unpublished study prepared by
Toxicol Laboratories Ltd. 106 p.

42921501	Buser, S. (1990). Determination of the Acute Oral Toxicity of
Ro 17-0099/000 (Copper 8-Quinolinolate TGAI) in the Rat: Lab Project
Number: B-157'235: 032A90Z. Unpublished study prepared by F. Hoffmann-La
Roche Ltd. 37 p.

42921502	 Buser, S. (1990). Determination of the Acute Dermal Toxicity
of Ro 17-0099/000 (Copper 8-Quinolinolate TGAI) in the Rat: Lab Project
Number: B-157'234. Unpublished study prepared by F. Hoffmann-La Roche
Ltd. 21 p.

42921503	 Ullmann, L.; Porricello, T. (1993). Primary Skin Irritation
Study with Ro 17-0099/000 (Copper 8-Quinolinolate) in Rabbits (4-Hour
Semi-Occlusive Application on Intact and Abraided Skin): Lab Project
Number: 213344. Unpublished study prepared by Research & Consulting Co.,
AG. 29 p.

42921504	Ullmann, L.; Kups, A. (1988). Contact Hypersensitivity to Ro
17-0099/000 (Copper 8-Quinolinolate) in Albino Guinea Pigs (Maximization
Test): Lab Project Number: 213333. Unpublished study prepared by
Research & Consulting Co., AG. 46 p.

42937301	Buser, S. (1983). A 13-Week Toxicity Study with Ro-17-0099/000
(Copper 8-Quinolinolate) in Mice p.o. (Feed Admix): Lab Project Number:
RRB 104 777: 62 A 81: 104 777. Unpublished study prepared by F.
Hoffmann-La Roche & Co. Ltd. 135 p.

42957801	Coleman, M.; Taupin, P. (1990). K-37 (Copper 8-Quinolinolate):
13-Week Oral (Dietary) Rangefinding Study in the Mouse: Lab Project
Number: TOM/1/90. Unpublished study prepared by Toxicol Labs, Ltd. 211
p.

42957802	Hagemann, C. (1990). 28 Day Repeated Dose Dermal Toxicity Study
in the Rat: Lab Project Number: 911205: CGA 281881: Final Report: Lab
No. 911205. Unpublished study prepared by Ciba-Geigy Limited. 178 p.

42962301	Chetelat, A. (1989). Mutagenicity Evaluation of the Fungicide
Ro 17-0099/000 (Copper 8-Quinolinolate) with Salmonella typhimurium
(Ames test): Lab Project Number: B-116'875. Unpublished study prepared
by F. Hoffmann-La Roche Ltd. 38 p.

42962302	Chetelat, A.; Dresp, J. (1990). Micronucleus Test in the Mouse
Bone Marrow In Vivo After Oral Administration of the Fungicide Ro
17-0099/000 (Copper 8-Quinolinolate): Lab Project Number: B-116'890.
Unpublished study prepared by F. Hoffman-La Roche Ltd. 20 p.

42962303	Strobel, R. (1990). In vivo/in vitro Rat Hepatocyte DNA Repair
Test with the Fungicide Ro 17-0099/000 (Oxine Copper-Copper
8-Quinolinolate) (Unscheduled DNA Synthesis Test: Lab Project Number:
B-154'904. Unpublished study prepared by F. Hoffmann-La Roche Ltd. 158
p.

42962304	Dennis, S. (1991). Ro 17-0099/022 (Carbon 14)-Copper
8-Quinolinolate): Metabolism of Ro 17-0099/022 in the Rat Tissues and
Excreta after Single Oral, Repeated Oral Administrations and After a
Single Oral Administration to Bile Duct Cannulated Rats: Lab Project
Number: RES-MET Q14. Unpublished study prepared by Dr. R. MAAG AG. 48 p.

42962305	Van Dijk, A., Baranowski, D. (1991). Ro 17-0099/022 (Carbon
14)-Copper 8-Quinolinolate): Absorption, Distribution and Excretion
after Single Oral, Repeated Oral Administration to the Rat and After
Single Oral Administration to Bile Cannulated Rats: Lab Project Number:
276118. Unpublished study prepared by RCC UMWELTCHEMIE AG. 95 p.

42986801	Buser, S.; Mettler, F. (1990). 13-Week Oral (Dietary) Toxicity
in the Rat with the Fungicide Ro 17-0099/000 (Oxine Copper): Lab Project
Number: B-157'249: 269302: 026A90. Unpublished study prepared by F.
Hoffmann-La Roche & Co. Ltd. 465 p.

42986802 	Schlappi, B.; Jovanovic, B. (1990). Ro 17-0099/000: 13-Week
Oral Toxicity Study (by Capsules) on Dogs with the Fungicide Ro
17-0099/000 (Copper 8-Quinolinolate): Lab Project Number: B-154'807:
024A90: RRB 154'807. Unpublished study prepared by F. Hoffmann-La Roche
& Co. Ltd. 306 p.

42986803 	Bacchus, C. (1992). Ro 17-0099/000 (Copper 8-Quinolinolate):
Oral (Gavage) Embryo Toxicity Study in the Rat with the Fungicide Ro
17-0099/000: Segment II Study with Post Natal Evaluation: Lab Project
Number: B-154'980: 284027: 273677. Unpublished study prepared by F.
Hoffmann-La Roche Ltd. 155 p.

43267201 	Husband, R. (1994). K-37 (Copper 8-Quinolinolate): 80-Week
Oral (Dietary) Carcinogenicity Study in the Mouse: Lab Project Number:
TOM/2B/93. Unpublished study prepared by Toxicol Laboratories Ltd. 2279
p.

43267202 	Bryson, A. (1994). Technical CGA 281881 (Copper
8-Quinolinolate): A Study of the Effect on Reproductive Function of Two
Generations in the Rat: Lab Project Number: 911382: CBG/576/931390:
567/931390. Unpublished study prepared by Huntingdon Research Centre
Ltd. 323 p.

43558501 	Driscoll, R. (1993). Oxine Copper Technical (K-37): acute
dermal toxicity (limit test) in the rat. Safefarm Laboratories Limited,
Derby, UK. Laboratory Prokject Identification 386/39. October 8, 1993.
Unpublished.

43572401 	Coleman, M. and P. Taupin (1990). K-37 133 week oral (dietary)
rangefinding study in the mouse. Toxico Laboratories Limited, Bromyard
Road, Ledbury, Herefordshire, HR8 1LH, England. Toxicol Report Reference
No. TOM/1/90. November 1990. Unpublished.

43611901        Jackson, G. (1987) K-37 (Copper 8-Quinolinolate): Acute
Inhalation Toxicity in the Rat: Lab Project Number: AGK 1/87926.
Unpublished study prepared by Huntingdon Research Centre Ltd. 54 p.

Open Literature

Algate, D.R., P.L. Munt. and C.Mejer-Aspell. (1990). Copper
8-Quinolinolate Technical Assessment of Effects on Hexobarbital Induced
Sleeping Time in the Mouse. Unpublished report prepared by Huntington
Research Centre, Ltd. Huntington, Cambridgeshire, England.

Algate, D.R., P.L. Munt. and C.Mejer-Aspell. (1990). Copper
8-Quinolinolate Technical Assessment of Effects On Motor Coordination in
the Mouse. Unpublished report prepared by Huntington Research Centre,
Ltd. Huntington, Cambridgeshire, England.

Algate, D.R., P.L. Munt and C.Mejer-Aspell. (1990). Copper
8-Quinolinolate Technical Investigation of Possible Neurological Effects
on the Rat Using The Tilting Plane Test. Unpublished report prepared by
Huntington Research Centre, Ltd. Huntington, Cambridgeshire, England.

National Toxicology program (NTP) (1985). NTP Technical report on the
Toxicology and Carcinogenesis of 8-Hydroxyquinoline (CAS No. 148-24-3)
in F344/N Rats and B6C3F1 Mice (feed Studies). EG&G Mason Research
Institute, Rockville, MD. NTP TR 276 (NIH Publication No. 85-2532;
NTP-83-029), April, 1985. Published by the U.S. Department of Health and
Human Services.

Dietary References

Food and Drug Administration (FDA), 2003, “Guidance for Industry:
Preparation of food Contact Notifications and food Additive Petitions
for Food contact Substances: Chemistry Recommendations, Final
Guidance”

FDA, 2003,   HYPERLINK "http://www.cfsan.fda.gov/~opa2pmmne.html"
http://www.cfsan.fda.gov/~opa2pmmne.html

FDA, 2003, “Sanitizing solutions: Chemistry Guidelines for Food
Additive Petitions, January 1993.   HYPERLINK "http://www/"  http://www.
Cfsan.fda.gov/~dms/opa-cg3a.html.

Environmental Fate References

42899001        A. Kesterson, B.A. and Brenda Lawrence. (1993).
Hydrolysis of [14C] Oxine Copper at pH 5, 7 and 9, Study performed by
PTRL East Inc., Richmond, KY. Final Report # 1244.

42925501        Dr. S. Dennis. (1991). Ro 17-0099/022 (14C-Copper
8-Quinolinolate) Photodegradation Studies in Aqueous Solution. Study
Performed by Metabolism Section (RES), Switzerland, Project #: RES-MET
Q13.

42925503        Dr. S. Sack. (1991). Ro 17-0099/022: Laboratory Non-Aged
Leaching              Study. Study Performed by Metabolism Section
Department of Registration and Environmental Studies (RES), Switzerland.
Project #: RES-MET Q102.

42925504        Dr. S. Sack. (1991). Ro 17-0099/022: Laboratory Non-aged
Leaching Study. Study Performed by Metabolism Section Department of
Registration and Environmental Studies (RES). Switzerland. Project #:
RES-MET Q103.

43620602        Electrostatic Application of NYTEK 10BL: Leaching of
Copper 8-Quinolinolate From Hemlock Wood.

Study Author: Matthew Crowe, PhD

Submitted by: Maag Agrochemicals, Inc. Vero Beach, Florida

Performing Waste Management Group: Applied Biology Division, British
Columbia Research Corporation, Vancouver, BC V6S 2 L2

Laboratory Report #: 2-51384-HEM

43620603        Electrostatic Application of NYTEK 10BL-PUR: Leaching of
Copper 8-Quinolinolate From Douglas Fir Wood

Study Author: Matthew Crowe, PhD

Submitted by: Maag Agrochemicals, Inc. Vero Beach, Florida

Performing Waste Management Group: Applied Biology Division, British
Columbia Research Corporation, Vancouver, BC V6S 2 L2

43667001	Leaching of Copper Oxinate(Copper 8-Quinolinolate) From Lumber
Spray Treated With Maag Sapstain Control Formulations, 1991

Study Authors: A. Byrne and D. Minchin

Submitted by: Maag Agrochemicals, Inc. Vero Beach, Florida

Performing Laboratory:Forintek Canada Corporation, Vancouver, BC V6T 1W5

Laboratory Report #: 17930425

43677301       Y. Esumi. (1995). Oxine Copper Technical (K-37):
Metabolism in Aerobic Soil. Study performed by Tokai Research
Laboratories Daiichi Pure Chemicals Co., Ltd., Shizuoka City, Japan.
Project#: AE-976-1.

Product Chemistry References

42922701C  Oxine Copper, 1990 by J. Freyre and G. Griffon. LA Quinoleine
S.A, Usine   D’Oissel, France

43532901  Product Chemistry of Copper-8-Quinoinolate, 1994, by Tomio
Katoh. Chemical Research Lab, Lab ID#: TOM-EPA-1.

43563001  Product Chemistry of Copper-8 Quinoinolate, 1994, by Tomil
Katoh. Chemical Research Lab. ID# TOM-EPA-1.

46346401C and 46346401  Product Identity and Composition of Q8 Log Oil
by Michael Kellog. 2004. Study #: 200401.

46438601C and 46438601  Product Chemistry Data on Osmose ORD-X378, 2004.
By Teri Muchow. Study ID#:  OSMOSE-2004-6.

46835201C and 46835201   Product Chemistry Data,
Cooper-8-Hydroxyquinoline (COX), 2006 by Bruce Bernard, PhD. Lab: SRA
International. Sonsor ID#: COX 2006-2.

Occupational Residential Exposure Assessment

455021101	American Chemistry Council (ACC). 2002.  Assessment of
Potential Inhalation and Dermal Exposure Associated With Pressure
Treatment of Wood with Arsenical Wood Products.

45524304	Bestari et al., 1999. [Sapstain Industry Group (SIG)-Consortium
Task Force] Measurement and Assessment of Dermal and Inhalation
Exposures to Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the
Protection of Cut Lumber (Phase III). Unpublished Study Prepared by
University of Guelph. 309 p. (SIG Task Force #73154).

Bharat Textiles. 2007. Weight/Density Estimate for Army Duck Canvas
taken from a Specification Chart on the internet site   HYPERLINK
"http://www.tentandcanvas.com/product.htm"
http://www.tentandcanvas.com/product.htm  of this canvas exporter. Last
viewed April 18, 2007.

  SEQ CHAPTER \h \r 1 Freeman, N , Jimenez M, Reed KJ,Gurunathan S,
Edwards RD, Roy A, Adgate JL, Pellizzari ED, Quackenboss J, Sexton K,
Lioy PJ, 2001.  Quantitative analysis of children’s microactivity
patterns:  The Minnesota Children’s Pesticide Exposure Study.  Journal
of Exposure Analysis and Environmental Epidemiology.  11(6): 501-509.

SIMetric. 2005.    HYPERLINK
"http://www.simetric.co.uk/si_materials.htm"
http://www.simetric.co.uk/si_materials.htm   Last viewed November 9,
2005.

USEPA.  1997.  Standard Operating Procedures (SOPs) for Residential
Exposure Assessments.  EPA Office of Pesticide Programs(Human Health
Effects Division (HED). Dated December 18, 1997.

USEPA.  1997a.  Exposure Factors Handbook. Volume I-II.  Office of
Research and Development.  Washington, D.C.  EPA/600/P-95/002Fa. August
1997.

USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure
from the Pesticide Handler Exposure Database Version 1.1.   Washington,
DC:  U.S. Environmental Protection Agency.

  SEQ CHAPTER \h \r 1 USEPA. 1999.  Evaluation of Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study (Amended on December
8,1992).  Memorandum from Siroos Mostaghimi, PH.D., USEPA to Julie
Fairfax, USEPA. Dated November, 4 1999.  DP Barcode D247642.

USEPA.  2000.  Standard Operating Procedures (SOPs) for Residential
Exposure Assessments. Prepared for EPA Office of Pesticide Programs,
Health Effects Division. Dated April 5, 2000.

USEPA.  2001.  HED Science Advisory Council for Exposure. Policy Update,
November 12, 2001.  Recommended Revisions to the Standard Operating
Procedures (SOPs) for Residential Exposure Assessment, February 22,
2001.

USEPA. 2003.  Assessment of the Proposed Bardac Wood Preservative
Pressure Treatment Use.  Memorandum from Tim Leighton and Siroos
Mostaghimi.  February 11, 2003.

USEPA. 2004.  Occupational and Residential Exposure Assessment for
Carboquat WP-50.  Memorandum from Siroos Mostaghimi, USEPA to Velma
Noble, USEPA.   Dated November 4, 2004. DP Barcodes D303714 and D303938.

USEPA.  2005.  Antimicrobials Division’s Draft Standard Operating
Procedures for Occupational and Residential Exposure Assessments.  July,
2005. (Unpublished Internal Guidance).

USEPA.  2005a. A Probabilistic Exposure Assessment for Children Who
Contact CCA-Treated Playsets and Decks.  Final Report, February, 2005.
US EPA Office of Research and Development, National Exposure Research
Laboratory.

USEPA.  2006.  Coppers: Second Revised Human Health Chapter of the
Reregistration Eligibility Decision Document (RED). Reregistration Case
Numbers 0636, 0649, 4025 and 4026. DP Barcode 319683. Dated January 17,
2006. Document ID: EPA-HQ-OPP-2005-0558-0006. (EPA Docket:
EPA-HQ-OPP-2005-0558; Copper Cases; Coppers Reregistration Eligibility
Decision, Notice of Availability, January 25, 2006.).

USEPA. 2006a. Review Memorandum: Oxine Copper (copper 8-quinolinolate)
– Endpoint Selection Report from T.F. McMahon, Ph.D., Senior
Toxicologist, AD. June 13, 2006.

USEPA. 2006b. Meeting Minutes of SMART Meeting Conference Call for
Copper 8-Quniolinolate. Reregistration Case 4026. November 8, 2006.
Transmittal from K. Avivah Jakob, Chemical Review Manager, USEPA to
Copper 8-Quniolinolate RED Team Members, USEPA. Dated November 16, 2006.

USEPA. 2006c. Review Memorandum: Environmental Fate Transport Assessment
for Copper 8-Quinolinolate from A. Najm Shamim, Ph.D., Chemist, AD.
November 3, 2006.

Eco-toxicity References

42899002	Ward, G. (1993). Oxine Copper (Copper 8-Quinolinolate): Acute
Toxicity to Rainbow Trout, Oncorhynchus mykiss, Under Flow-Through Test
Conditions: Lab Project Number: J9006014A. Unpublished study prepared by
Toxikon Environmental Sciences.  43p.

42899003  	Ward, G. (1993). Oxine Copper (Copper 8-Quinolinolate): Acute
Toxicity to Bluegill, Lepomis macrochirus, Under Flow-Through Test
Conditions: Lab Project Number: J9006014B. Unpublished study prepared by
Toxikon Environmental Sciences.  44p.

42899004	Ward, G.; Davis, J. (1993). Oxine Copper (Copper
8-Quinolinolate): Acute Toxicity to Embryos and Larvae of the Eastern
Oyster, Crassostrea virginica, Under Static Test Conditions: Lab Project
Number: J9006014I. Unpublished study prepared by Toxikon Environmental
Sciences.  45p.

42899005  	Ward, G. (1993). Oxine Copper (Copper 8-Quinolinolate):
Chronic Toxicity to the Water Flea, Daphnia magna, Under Flow-Through
Test Conditions: Lab Project Number: J9006014F. Unpublished study
prepared by Toxikon Environmental Sciences.  52p.

42902401  	Carr, K.; Ward, G. (1993). Oxine Copper (Copper
8-Quinolinolate): Acute Toxicity to Coho Salmon, Oncorhynchus kisutch,
Under Flow-Through Test Conditions: Lab Project Number: J9006014C.
Unpublished study prepared by Toxikon Environmental Sciences.  44p.

42902402  	Ward, G. (1993). Oxine Copper (Copper 8-Quinolinolate): Acute
Toxicity to the Mysid, Mysidopsis bahia, Under Flow-Through Test
Conditions: Lab Project Number: J9006014J. Unpublished study prepared by
Toxikon Environmental Sciences.  42p.

42902403  	Lintott, D.; Ward, G. (1993). Oxine Copper (Copper
8-Quinolinolate): Toxicity to Embryos and Lavae of the Rainbow Trout,
Oncorhynchus mykiss, Under Flow-Through Test Conditions: Lab Project
Number: J9006014E. Unpublished study prepared by Toxikon Environmental
Sciences.  64p.

42902404  	Ward, G. (1993). Oxine Copper (Copper 8-Quinolinolate):
Toxicity to the Saltwater Alga, Nitzschia punctata, Under Static Test
Conditions: Lab Project Number: J9006014M. Unpublished study prepared by
Toxikon Environmental Sciences.  46p.

42902405 	Ward, G. (1993). Oxine Copper (Copper 8-Quinolinolate): Acute
Toxicity to the Saltwater Green Alga, Dunaliella tertiolecta, Under
Static Test Conditions: Lab Project Number: J9006014L. Unpublished study
prepared by Toxikon Environmental Sciences.  46p.

42927101 	Hakin, B.; Rodgers, M.; Grutzner, I. (1991). Ro 17-0099/000
(Copper 8-Quinolinolate): Acute Oral Toxicity (LD50) to the Bobwhite
Quail: Lab Project Number: HLR 184-901854: RCC 284253. Unpublished study
prepared by Huntingdon Research Centre Ltd.; RCC UMWELTCHEMIE AG. 53p.

42927102  	Hakin, B.; Rodgers, M.; Grutzner, I. (1991). Ro 17-0099/000
(Copper 8-Quinolinolate): Acute Oral Toxicity to Mallard Duck: Lab
Project Number: HLR 185-901733: RCC 284264.  Unpublished study prepared
by Huntingdon Research Centre Ltd.; RCC UMWELTCHEMIE AG. 38p.

42927103  	Hakin, B.; Rodgers, M.; Grutzner, I. (1991). Ro 17-0099/000
(Copper 8-Quinolinolate): Dietary Toxicity (LC50) to Bobwhite Quail: Lab
Project Number: HLR 187-901685: RCC 279854.  Unpublished study prepared
by Huntingdon Research Centre Ltd.; RCC UMWELTCHEMIE AG. 39p.

42927104  	Hakin, B.; Rodgers, M.; Grutzner, I. (1991). Ro 17-0099/000
(Copper 8-Quinolinolate): Dietary Toxicity (LC50) to the Mallard Duck:
Lab Project Number: HLR 186-901684: RCC 274228. Unpublished study
prepared by Huntingdon Research Centre Ltd.; RCC UMWELTCHEMIE AG. 39p.

43073501  	Ward, G. (1993). Oxine Copper (Copper 8-Quinolinolate): Acute
Toxicity to the Freshwater Alga, Skeletonema costatum, Under Static Test
Conditions: Lab Project Number: J9006014K. Unpublished study prepared by
Toxikon Environmental Sciences.  45p.

43228401  	Ward, G. (1994). Oxine Copper (Copper 8-Quinolinolate): Acute
Toxicity to the Water Flea, Daphnia magna, Under Flow-Through Test
Conditions: Lab Project Number: J9006014D. Unpublished study prepared by
Toxikon Environmental Sciences.  44p.

43563701 	Nozaka, T. (1995). Acute Toxicity of Copper 8-Quinolinolate to
Rainbow Trout: English Version: Lab Project Number: 90753:E89-0753.
Unpublished study prepared by Kurume Research Labs.  12p

Incident Report References

Teschke K, Hertzman C, Wiens M, Dimich-Ward H, Hershler R, Ostry A, and
Kelly S. 1992. Recognizing Acute Health Effects of Substitute
Fungicides? Are First- Aid Reports Effective? American Journal of
Industrial Medicine 21: 375-382.

Supporting Documents

AD’s End Point Selection Memo by Tim McMahon, June 13, 2006

Websites/Databases

EPI Suite. US EPA’s Estimation Program of Physical/Chemical
Characteristics of Chemicals.

APPENDIX A

Toxicity Profile for Copper-8-quinolinolate

Table 3.3 Subchronic, Chronic, and other Toxicity Profile for Copper 8-
                                                   quinolinolate

Guideline number/Study Type/Test Substance

 (% a.i.)

MRID number (Year)/Citation/Classification/Doses

Results

Copper 8- quinolinolate (case #4026)

Copper 8- quinolinolate (PC code 024002)

870.3100 (§82-1a)

Subchronic oral - rat

99.5% a.i.

	MRID 42986801

Acceptable – Guideline

16/sex/dose at (0, 600 or 1000 mg/kg/day)

10/sex/dose at (30, 100 or 300 mg/kg/day)

for 13 weeks

NOAEL = 30 mg/kg/day

LOAEL = 100 mg/kg/day, based on statistically significant ALT, AST and
bilirubin in males, increased spleen weights in females, increased
incidence of diffuse degeneration, focal necrosis, extramedullary
hematopoises in liver.

870.3100 (§82-1a)

Subchronic oral - mouse

Oxine Cu purity 99.9%

	MRID 42937301

Supplementary

6/sex/dose

0, 30, 600, or 1000 mg/kg/day

(100 and 300 mg/kg/day for 13 weeks)

No signs of toxicity were observed at the highest dose tested. (1000
mg/kg/day) The high dose, which is a mean of three different doses (30,
600 and 1000 mg/kg/day) of only 473 mg/kg/day, was not a limit dose, and
therefore, it therefore, it appeared that the compound was not tested at
a high enough dose.

In the absence of other signs of toxicity, a change in one enzyme level
cannot be used to determine the NOEL and LOEL of this chemical.

870.3100 (§82-1a)

Subchronic oral - mouse

Oxine Cu purity – not given

	MRID 42957801

Range-finding

10 mice/sex/dose

0, 300, 1000, 3000 or 6000 ppm for 13 weeks

Tentative NOAEL: 1000 ppm

Tentative LOAEL :

Apparent treatment-related thickening and pallor of the glandular mucosa
of the stomach in 4/10 females.  Abnormal coloration (pallor) of the
glandular stomach mucosa was seen in 2/10 males at 3000 ppm and 6000,
1/10 was also thickened at the 6000 ppm dose. An increased incidence of
raised, cystic areas in the ovaries at 6000 ppm. The 6000 ppm dose was
recommended as the high level for

the subsequent carcinogenicity

Guideline number/Study Type/Test Substance

 (% a.i.)

MRID number (Year)/Citation/

Classification/Doses

Results

study.

870.3150 (§82-1a)

Subchronic - dog

99.5% a.i.

	MRID 42986802

Acceptable

4/sex/dose

0, 5, 50, or 250 mg/kg/day

for 13 weeks	NOAEL = 5 mg/kg/day

LOAEL = 50 mg/kg/day, based on vomiting, reduced total plasma protein
and albumin, reddened mucosa and hyperemia in stomach or small
intestine.

870.3200 (§82-2)

28 day dermal - rat

99.7% a.i.

	MRID 42957802

Acceptable - Guideline

5/sex/dose

0, 50, 200, or 1000 mg/kg/day, 6 hours/day for 4 weeks

Dermal irritation

Tentative NOAEL = 1000 mg/kg/day

Tentative LOAEL > 1000 mg/kg/day, not established

Systemic toxicity

NOAEL = 200 mg/kg/day

LOAEL = 1000 mg/kg/day, based on necrosis of the thymic lymphocytes.

870.4300 (§83-1)

Chronic - rat

96%

	MRID 00083777

Core-Minimum

30/sex/dose

M/F: 0, 5, 20, 100, 500 or 2000 ppm for 102 weeks

Tentative NOAEL: 500 ppm

Tentative LOAEL: 2000 ppm, based on increased concentration of copper in
tissues accompanied by histomorphologic effects.  The incidence of
neoplasia was comparable between the control and treated animals.

When compared to the concentration of copper in the tissues of the
control rats, moderate to marked increases in copper content were noted
in the livers of group 6

(2000 ppm) rats of both sexes sacrificed at 52 and 102 weeks.  Slight to
moderate increases in copper content were also noted in the kidneys of
group 5 (500 ppm) and group 6 (2000 ppm) males and the group 4 (100 ppm)
group 5 (500 ppm) and group 6 (2000

ppm) females sacrificed at 52 weeks and in the group 6 males

and the group 2, 4, 5 and 6 females sacrificed at 102 weeks.

The coppe brains of group 5 and group 6 r concentration in the

Guideline number/Study Type/Test Substance

 (% a.i.)

MRID number (Year)/Citation/

Classification/Doses

Results

males sacrificed at 102 weeks were very slightly increased.  The tissue
copper contents in the rats of the other treated groups weregenerally
comparable to those of the control rats.

There was no evidence of a compound-related effect with regard to
physical appearance and behavior.

870.4100 (§83-1)

Chronic - dog

96%

	MRID 00099606

Core-Minimum

4/sex/dose for 6 groups

M/F: 0, 10, 40, 200, 1000 or 3000 ppm  for 102 weeks

Tentative NOAEL: 200 ppm

Tentative LOAEL: 1000 ppm, based on histological alteration in the liver
and lung correlated with an increase in copper content.

In dogs treated at levels up to 1000 ppm, no effects attributable to
compound administration were noted in evaluations of mortality data,
general appearance and behavior, body weight and food consumption
values, clinical lab values or organ weights and organ/body weight
ratios.

In addition, evaluations of tissue copper analyses values and gross and
histologic pathology data revealed no findings indicative of an effect
from compound in animals treated at levels up to and including 200 ppm.
At the 1000 ppm level, no compound related-findings were observed in the
one male and one female sacrificed at 52 weeks.  In those dogs
sacrificed at 104 weeks, moderate

increase in copper content were noted in the livers of all the dogs and
compound-related histomorphologic alterations of the lung (subpleural
inflammation) and liver (focal accumulations of pigment-laden

kupffer cells) were noted in one female dog.

Guideline number/Study Type/Test Substance

 (% a.i.)

MRID number (Year)/Citation/

Classification/Doses

Results

In the dogs treated with compound at a level of 3000 ppm,
compound-related findings were noted in the majority of the parameters
evaluated.  These findings the following: inappetence resulting from the
impalatibility of the test diet (primarily noted when being treated at a
level of 4000 ppm), mortality in the second year in 4 of the 6 animals
remaining on study after the 52 week interval sacrifice; general
unhealthy appearance in all dogs during the second year; body weight
losses, suppressions in food consumption, hematology findings indicative
of anemia, and blood chemistry findings indicative of hepatoxicity
during both years of the study; marked increase in copper contents of
brain, spleen, livers and kidneys of  the males and females and
histomorphologic alterations involving a variety of tissues examined.
Principal tissue alterations were liver, kidney, lung, spleen and
anterior mesenteric lymph nodes.

870.4200 (§83-2)

Carcinogenicity-Mouse

97.2%

DER #8

MRID 43267201

Acceptable – Guideline

50.sex/dose

0,100,400, 1500, or 6000 ppm (M: 0, 14.5, 57,1, 207.7, or 855.8
mg/kg/day, F: 0, 16.1, 66.2, 246.2, or 1051.7 mg/kg/day)

NOAEL = 57.1 mg/kg/day (M)

        = 66.2 mg/kg/day (F)

LOAEL  = 207.7 mg/kg/day (M)

               =  246.2 mg/kg/day (F), based on increased incidence of
stomach ulcers in males and mild anemia and adverse liver effects in
females.

No dose-related increases in individual neoplastic lesions were
observed.

Guideline number/Study Type/Test Substance

 (% a.i.)

MRID number (Year)/Citation/

Classification/Doses

Results

870.3700 (§83-3)

Carcinogenicity-Mouse

98.5%

DER #9

MRID  4298603

Acceptable –Guideline

36/dose

0, 50, 200, or 800 mg/kg/day,

GD 6-15

Maternal Toxicity

NOAEL = 200 mg/kg/day

LOAEL = 800 mg/kg/day, based on increased clinical signs (piloerection,
poor general condition, encrustation of nose and mouth), and decreased
body weight and gain.

Developmental toxicity

No dev. Tox observedentative NOAEL = 800 mg/kg/day

Tentative LOAEL > 800 mg/kg/day, not established

870.3700 (§83-3)

Carcinogenicity-Mouse

96.5%

DER # Not Reviewed

MRID 41063702

Not Reviewed

4 groups @ 16/dose

0, 7, 15, or 30 mg/kg/day, GD 7-19

Maternal Toxicity

Tentative NOAEL= 30 mg/kg/day (HDT) maternal body weight was not
affected as wel as the body weight gain for the treated groups was
similar to the control group.

There was no adverse effecte on food consumption at the HDT (30
mg/kg/day).

Developmental toxicity

Tentative NOAEL = 30 mg/kg/day (HDT)

870.3800 (§83-4)

Reproduction - Rat

> 99.7%

DER # 10

MRID 43267202

Acceptable – Guideline

F0: 32/sex/dose

F1: 28/sex/dose

0, 25, 250, or 2500 ppm

(F0: 0, 1.8/2, 18.2/20.8, 181/203 mg/kg/day M/F, F1: 0, 2/2.2,
19.8/22.8, 96/218 mg/kg/day M/F)

Parental – Systemic

NOAEL = 250 ppm

LOAEL = 2500 ppm, based on increased liver weight in F1 males.

Reproduction

NOAEL = 250 ppm

LOAEL = 2500 ppm, based on decreased mean number of live pups at birth
(85% of controls) and decreased litter weights at day 0 and during
lactation in F1 generation.

Guideline number/Study Type/Test Substance

 (% a.i.)

MRID number (Year)/Citation/

Classification/Doses

Results

870.3800 (§83-4)

Reproduction - Rat

> 96%

DER # 11

MRID 0079233

Core minimum

P1: 25/sex/dose

P2: 25/sex/dose

P1 & p2: 0, 20, 100 and 500 ppm

	Tentative NOAEL: >500 ppm (HDT)

Parental:

Food and water consumption showed no treatment-related effects. No
deaths occurred nor were any signs of compound-induced toxicity
observed, during the growth, gestation, or lactation periods of either
parental generation. The pregnancy rates and parturition indices (number
of females delivering viable offspring/total umber of females) of all
the groups were considered comparable at both matings of both parental
generations. Evaluations of the live birth

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n viability between the treated and control group offspring obtained
from either mating trial of the P1 and P2 generations.

No treatment-related findings were observed in gross pathology in the
selected offspring in the F1b generation sacrificed at weaning.

No deaths or signs of compound induced toxicity were observed in the F1b
or F2b generation offspring maintained for 5 weeks and 3 months
postweaning.

870.5100 (§84-2)

Mutagenicity - Ames

Purity not reported

MRID 00248746

Acceptable – Guideline

Strain: TA1535, TA1537,TA1538, TA98 and TA 100

– 0.3 µL/plate (0.2 and 0.3 µL/plate were toxic)

Positive

Induced increase in histidine reverants in one strain TA 100, possible
also TA 1538 and TA 98 with metabolic activation (weak mutagen).

Guideline number/Study Type/Test Substance

 (% a.i.)

MRID number (Year)/Citation/

Classification/Doses

Results

870.5100 (§84-2)

Mutagenicity - Ames

Purity99.7%

MRID 42962301

Acceptable – Guideline

TA97, TA98, TA100, TA102,

TA1535, TA1537, TA1538; S. Typhimurium; concentrations: 0.33 – 100
µL/plate (standard assay), 0.51 – 50 µL/plate (pre-incubation)

Positive

Dose-related weakly positive reverse gene mutation in S9-activated
bacterial strains TA97, TA100, TA102 of S. typhimyrium exposed up to
toxic doses.

870.5395 (§84-2)

Mutagenicity –Micronucleus test in the Mouse Bone Marrow

Purity 98.5%

MRID 42962302

Acceptable – Guideline

Mouse – 5 mice/sex/dose Administered orally at 0, 3750, 7500 mg/kg

Negative

For induction in bone marrow cells of mice treated once at doses up to
7500 mg/kg, a non-toxic (but limiting) dose.

870.5550 (§84-2)

Mutagenicity –Unscheduled DNA synthesis

Purity 99.7%

MRID 42962303

Unacceptable

Rat – Male 1-3/dose group gvaged once at 100, 500, 1000, 1500,a 2500
and 3000 mg/kg

Negative

For induction of unscheduled DNA synthesis in primary rat hepatocyte
cultures isolated from male rats treated orally up to 3000 mg/kg, as
determined by radioactive tracer procedures [nuclear silver grain
counts].

870. 7485 (§85-1)

Metabolism – rat

Purity >98.5% (unlabeled); >98% radiolabeled material

MRIDs 42962304, 42962305

Acceptable – Guideline

30 or 1000 mg/kg (unlabeled, daily for 14 days) single labeled 30 mg/kg
Major route of excretion via urine (62-68%) and feces (8-26%) within 45
hours. Rapid absorption inferred by rapid excretion of metabolites in
urine. Radioactivity in tissue residues very low in all tissues
including blood (<0.05%). Bioaccumulation is minimal. Radioactivity in
urine associated with parent (5-16%) and sulfate (12-18%) of the parent.
In feces, radioactivity associated with parent (4-23%) and glucuronide
conjugate of the parent (0.1-4%).

  Testing with the more sensitive species (freshwater or
estuarine/marine) based on acute toxicity test results is required.

 PAGE  2

 PAGE  50

 PAGE

 PAGE   71


[Federal Register Volume 85, Number 90 (Friday, May 8, 2020)]
[Notices]
[Page 27506]
[FR Doc No: 2020-09833]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2020-0434]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: Passenger
Facility Charge (PFC) Application

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the
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 the FAA's administration of the
Passenger Facility Charge (PFC) program. The information to be
collected will be used to authorize public agencies to impose PFCs and
use PFC revenue on airport-related projects and to ensure compliance
with PFC program requirements.

DATES: Written comments should be submitted by July 7, 2020.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Rachel McCoy, Office of Airport Planning and Programming,
Federal Aviation Administration, 800 Independence Ave. SW, Suite 620,
Washington, DC 20591.
    By fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For further information please contact
Vanessa Balgobin by email at<EMAIL_ADDRESS>phone: 202-267-
3867.

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: 2120-0557.
    Title: Passenger Facility Charge (PFC) Application.
    Form Numbers: FAA Form 5500-1.
    Type of Review: Renewal of an information collection.
    Background: The DOT/FAA will use any information submitted in
response to this collection to carry out the intent of 49 U.S.C. 40117.
This statute authorizes public agencies controlling airports to impose
PFCs and use PFC revenues. The information collected enables the FAA to
approve the collection of PFC revenue for projects which preserve or
enhance safety, security, or capacity of the national air
transportation system, or which reduce noise or mitigate noise impacts
resulting from an airport, or which furnish opportunities for enhanced
competition between or among air carriers, and to provide oversight of
the PFC program, as required by statute.
    Respondents: Approximately 475 respondents annually.
    Frequency: On occasion.
    Estimated Average Burden per Response: 8 hours.
    Estimated Total Annual Burden: 22,054 hours.

    Issued in Washington, DC, on May 4, 2020.
David F. Cushing,
Manager, Airports Financial Assistance Division, APP-500.
[FR Doc. 2020-09833 Filed 5-7-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 102 (Tuesday, May 28, 2019)]
[Notices]
[Pages 24500-24501]
[FR Doc No: 2019-11165]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-1889-000]

Antrim Wind Energy LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Antrim Wind Energy LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 10, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC

Online service, please email<EMAIL_ADDRESS>or call (866)
208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 21, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-11165 Filed 5-24-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Pages 46764-46765]
[FR Doc No: 2016-16843]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0003; Notice 2]

Continental Tire the Americas, LLC, Grant of Petition for
Decision of Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition.

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

SUMMARY: Continental Tire the Americas, LLC (CTA), has determined that
certain CTA tires do not fully comply with paragraph S5.5(f) of Federal
Motor Vehicle Safety Standard (FMVSS) No. 139 New Pneumatic Radial
Tires for Light Vehicles. CTA filed a report dated December 11, 2015,
pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility
and Reports. CTA then petitioned NHTSA under 49 CFR part 556 requesting
a decision that the subject noncompliance is inconsequential to motor
vehicle safety.

ADDRESSES: For further information on this decision contact Abraham
Diaz, Office of Vehicle Safety Compliance, the National Highway Traffic
Safety Administration (NHTSA), telephone<PHONE_NUMBER>, facsimile
(202) 366-5930.

SUPPLEMENTARY INFORMATION:

I. Overview

    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing
regulations at 49 CFR part 556), CTA submitted a petition for an
exemption from the notification and remedy requirements of 49 U.S.C.
Chapter 301 on the basis that this noncompliance is inconsequential to
motor vehicle safety.
    Notice of receipt of the petition was published, with a 30-day
public comment period, on March 25, 2016 in the Federal Register (81 FR
16269). No comments were received. To view the petition and all
supporting documents log onto the Federal Docket Management System
(FDMS) Web site at: http://www.regulations.gov/. Then follow the online
search instructions to locate docket number ``NHTSA-2016-0003.''

II. Tires Involved

    Affected are approximately 1,800 General Tire brand Grabber size
LT265/75R16 112/109 Q LRC tires that were manufactured between December
10, 2010 \1\ and September 9, 2013.
---------------------------------------------------------------------------

    \1\ Subsequent to the original filing, CTA informed NHTSA that
the original manufacture start date as stated in their part 573
should in fact be November 7, 2010.
---------------------------------------------------------------------------

III. Noncompliance

    CTA explains that due to a mold error, the number of tread plies
indicated on the sidewall of the subject tires does not match the
actual number of plies in the tire construction. The tires are marked
``PLIES: TREAD: 2 POLYESTER + 2 STEEL + 2 POLYAMIDE'' whereas the
correct marking should be: ``PLIES: TREAD: 2 POLYESTER + 2 STEEL + 1
POLYAMIDE.'' As a consequence, these tires do not meet requirements
specified in paragraph S5.5(f) of FMVSS No. 139.

IV. Rule Text

    Paragraph S5.5(f) of FMVSS No. 139 states, in pertinent part:

    S5.5 Tire Markings. Except as specified in paragraph (a) through
(i) of S5.5, each tire must be marked on each sidewall with the
information specified in S5.5(a) through (d) and on one sidewall
with the information specified in S5.5(e) through (i) according to
the phase-in schedule specified in S7 of this standard . . .
    (f) The actual number of plies in the sidewall, and the actual
number of plies in the tread area, if different.

V. Summary of CTA's Petition

    CTA described the subject noncompliance and stated its belief that
the noncompliance is inconsequential to motor vehicle safety.
    In support of its petition, CTA submitted the following information
pertaining to the subject noncompliance:
    (a) CTA stated that the tires covered by this petition are labeled
with incorrect information regarding the number of tread plies. The
company noted that while the number of polyester and steel plies
indicated on the sidewall is accurate, the number of polyamide plies
indicated is incorrect. The company contended, however, that this
mislabeling has no impact on the operational performance of these tires
or on the safety of vehicles on which these tires are mounted. The
company asserted that the tires meet or exceed all of the performance
requirements of FMVSS No. 139.
    (b) CTA noted that NHTSA has concluded in response to numerous
other petitions that this type of noncompliance is inconsequential to
motor vehicle safety. CTA referenced notices that NHTSA has published
in

the Federal Register granting the following inconsequentiality
petitions:
     Petition of Hankook Tire America Corp., 79 FR 30688 (May
28, 2014);
     Petition of Bridgestone Americas Tire Operations, LLC, 78
FR 47049 (August 2, 2013);
     Petition of Cooper Tire & Rubber Company, 78 FR 47050
(August 2, 2013).
    (c) CTA states that all tires covered by its petition meet or
exceed the performance requirements of FMVSS No. 139, as well as the
other labeling requirements of the standard.
    (d) CTA also states that it is not aware of any crashes, injuries,
customer complaints, or field reports associated with the subject
noncompliance.
    CTA additionally informed NHTSA that it has quarantined all
existing inventory of the tires that contain the noncompliant tire
sidewall labeling and has corrected the molds at the manufacturing
plant so that no additional tires will be manufactured with the
noncompliance.
    In summation, CTA believes that the described noncompliance is
inconsequential as it relates to motor vehicle safety, and that its
petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and to remedy the
noncompliance, as required by 49 U.S.C. 30120, should be granted.

NHTSA'S Decision

    NHTSA'S Analysis: The agency agrees with CTA that the noncompliance
is inconsequential to motor vehicle safety. The agency believes that
one measure of inconsequentiality to motor vehicle safety in this case
is that there is no effect of the noncompliance on the operational
safety of vehicles on which these tires are mounted. The safety of
people working in the tire retread, repair and recycling industries
must also be considered and is a measure of inconsequentiality.
    Although tire construction affects the strength and durability of
tires, neither the agency nor the tire industry provides information
relating tire strength and durability to the number of plies and types
of ply cord material in the tread sidewall. Therefore, tire dealers and
customers should consider the tire construction information along with
other information such as the load capacity, maximum inflation
pressure, and tread wear, temperature, and traction ratings, to assess
performance capabilities of various tires. In the agency's judgement,
the incorrect labeling of the tire construction information will have
an inconsequential effect on motor vehicle safety because most
consumers do not base tire purchases or vehicle operation parameters on
the number of plies in a tire.
    The agency also believes the noncompliance will have no measureable
effect on the safety of the tire retread, repair, and recycling
industries. The use of steel cord construction in the sidewall and
tread is the primary safety concern of these industries. In this case,
since the tire sidewalls are marked correctly for the number of steel
plies, this potential safety concern does not exist.
    NHTSA'S Decision: In consideration of the foregoing, NHTSA finds
that CTA has met its burden of persuasion that the subject FMVSS No.
139 noncompliance in the affected tires is inconsequential to motor
vehicle safety. Accordingly, CTA's petition is hereby granted and CTA
is consequently exempted from the obligation of providing notification
of, and a free remedy for, that noncompliance under 49 U.S.C. 30118 and
30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision
only applies to the subject tires that CTA no longer controlled at the
time it determined that the noncompliance existed. However, the
granting of this petition does not relieve equipment distributors and
dealers from the prohibitions on the sale, offer for sale, or
introduction or delivery for introduction into interstate commerce of
the noncompliant tires under their control after CTA notified them that
the subject noncompliance exists.

    Authority:  49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-16843 Filed 7-15-16; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 84, Number 204 (Tuesday, October 22, 2019)]
[Notices]
[Pages 56447-56448]
[FR Doc No: 2019-23001]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ20-2-000]

Oncor Electric Delivery Company LLC; Notice of Filing

    Take notice that on October 16, 2019, Oncor Electric Delivery
Company LLC submitted its tariff filing: Oncor Tex-La Tariff Rate
Changes to be effective 9/27/19.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and

interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the website that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on November 6, 2019.

    Dated: October 16, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-23001 Filed 10-21-19; 8:45 am]
 BILLING CODE 6717-01-P