[Federal Register Volume 85, Number 247 (Wednesday, December 23, 2020)]
[Notices]
[Pages 83971-83972]
[FR Doc No: 2020-28349]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0386]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Orphan Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by January 22, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0167. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Orphan Drugs

OMB Control Number 0910-0167--Revision

    This information collection supports FDA regulations implementing
sections 525, 526, 527, and 528 of the Federal Food, Drug and Cosmetic
Act (FD&C Act) (21 U.S.C. 360aa, 360bb, 360cc, and 360dd), as well as
related guidance. Sections 525, 526, 527, and 528 of the FD&C Act
pertain to the development of drugs for rare diseases or conditions,
including biological products and antibiotics, otherwise known or
referred to as ``Orphan Drugs.'' Specifically, section 525 of the FD&C
Act requires written recommendations on studies required for approval
of a marketing application for a drug for a rare disease or condition.
The information collection in 21 CFR 316.10, 316.12, and 316.14 is
approved under OMB control numbers 0910-0001 and 0910-0014. Section 526
of the FD&C Act provides for designation of drugs as orphan drugs when
certain conditions are met, section 527 provides conditions under which
a sponsor of an approved orphan drug enjoys exclusive FDA marketing
approval for that drug for the orphan indication for a period of 7
years, and, finally, section 528 is intended to encourage sponsors to
make investigational orphan drugs available for treatment of persons in
need on an open protocol basis before the drug has been approved for
general marketing. Open protocols may permit patients who are not part
of the formal clinical investigation to obtain treatment where adequate
supplies exist and no alternative effective therapy is available.
    We have issued regulations in part 316 (21 CFR part 316) to
implement the Orphan Drug provisions of the FD&C Act and to set forth
procedures and requirements related to requesting recommendations for
investigations of drugs for rare diseases or conditions, requesting
designation of a drug for a rare disease or condition, or requesting
exclusive approval for a drug for a rare disease or condition. To
assist respondents and to be consistent with Sec.  316.50, our Office
of Orphan Products Development (OOPD) maintains and makes publicly
available guidance documents that apply to the Orphan Drug provisions
of the FD&C Act and regulations in part 316. The list is maintained on
the internet and guidance documents are issued in accordance with our
Good Guidance Practice regulations in 21 CFR 10.115, which provide for
public comment at any time.
    Accordingly, we are revising the information collection to include
Agency guidance. The document entitled ``Meetings with the Office of
Orphan Products Development: Guidance for Industry, Researchers,
Patient Groups, and Food and Drug Administration Staff'' provides
recommendations to industry, researchers, patient groups, and other
stakeholders interested in requesting a meeting, including a
teleconference, with OOPD on issues related to orphan drug designation
requests, humanitarian use device designation requests, rare pediatric
disease designation requests, funding opportunities through the Orphan
Products Grants Program and the Pediatric Device Consortia Grants
Program, and orphan product patient-related topics of concern. It is
also intended to assist OOPD staff in addressing such meeting requests.
This guidance describes procedures for requesting, preparing,
scheduling, conducting, and documenting such meetings and discusses
background information we recommend be included in such requests.
Information collection attendant to recommendations in the guidance are
currently approved under OMB control number 0910-0787; however, for
efficiency of Agency operations, we are consolidating it into this
related information collection. The guidance is available at https://www.fda.gov/media/92815/download.
    The FDA Orphan Drug Designation Request Form (Form FDA 4035) is
intended to benefit sponsors who desire to seek orphan designation of
drugs intended for rare diseases or conditions from only FDA. The form
is a simplified

method for sponsors to provide only the information required by Sec.
316.20 for FDA to make a decision.
    During this public health emergency associated with the COVID-19
pandemic, the OOPD is providing sponsors with increased flexibility for
submission of orphan drug designation requests and related submissions
(amendments, annual reports, etc.). During this public health
emergency, orphan drug designation, humanitarian use device
designation, and rare pediatric disease designation requests and
submissions may be submitted electronically by email to the OOPD. When
transmitting information to the Orphan Drug Designation Program via
email, please utilize the mailbox<EMAIL_ADDRESS>We recommend
using the automated read receipt feature to avoid having to call to
verify receipt of the email. We also strongly encourage sponsors and
others who plan to email information to FDA that is considered to be
private, sensitive, proprietary, or commercial confidential to send it
from an FDA-secured email address, which is provided by FDA, so the
transmission is encrypted. The OOPD will assume that the addresses of
emails received or email addresses provided as a point of contact are
FDA secure when responding to those email addresses.
    In the Federal Register of October 2, 2020 (85 FR 62306), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    21 CFR section; activity         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Content and format of a request              534            1.25             668             135          90,180
 for designation; request for
 verification of status;
 amendment to designation.......
Sec.  Sec.   316.20, 316.21,                 534            1.25             668              32          21,376
 316.26 (Form FDA 4035).........
Sec.   316.22; Notifications of              132               1             132               2             264
 changes in agents..............
Sec.   316.24(a); Deficiency                  20               1              20               2              40
 letters and granting orphan-
 drug designation...............
Sec.   316.27; Submissions to                104               1             104               5             520
 change ownership of orphan-drug
 designation....................
Sec.   316.30; Annual reports...             744               1             744               3           2,232
Sec.   316.36; Assurance of the                1               3               3              15              45
 availability of sufficient
 quantities of the orphan drug;
 holder's consent for the
 approval of other marketing
 applications for the same drug.
Guidance Recommendations:                  2,508               1           2,508           3.595           9,016
 Meeting requests to OOPD and
 related submission packages....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         123,673
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on our evaluation, we have adjusted the currently approved
burden estimate we attribute to information collection activities
associated with our Orphan Drug program to reflect an increase in
submissions. This notice corrects the mathematical error published in
the 60-day notice, which indicated that the total burden was 123,623.

    Dated: December 17, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28349 Filed 12-22-20; 8:45 am]
BILLING CODE 4164-01-P


(Tram setter, stacker operator, loader operator, supervisor, test borer,
and tallyman) 	0.74	0.00160	13	1.37	0.0030	70	10,000

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

a. 	Unit exposure values taken from CCA study and are shown in Table
6.6.  It is assumed that the dermal and inhalation exposure to As (per
ppm of a.i.) is representative of exposure to Naphthenate Salts.

b. 	Absorbed Daily Dose (mg/kg/day) = Unit Exposure (μg As/ppm) x [%
Naphthenate Salts in solution (13) x 10,000 (parts per million
conversion)] x (0.001 mg/μg) x absorption factor (NA for dermal, 100%
for inhalation) / Body weight (70 kg).

c.			MOE = NOAEL (mg/kg/day) / Daily dose [Where IT dermal NOAEL = 100
mg/kg/day and ST/IT/LT inhalation NOAEL = 30 mg/kg/day]. Target MOE is
100 for dermal exposure and 1000 for inhalation exposure.

	7.5	Data Limitations/Uncertainties

				There are several data limitations and uncertainties associated with
the occupational handler exposure assessments which include the
following:

Certain surrogate dermal and inhalation unit exposure values were taken
from the proprietary CMA antimicrobial exposure study (US EPA 1999: DP
Barcode

D247642) or from the Pesticide Handlers Exposure Database (US EPA 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 values used in these assessments.

The quantities handled/treated were estimated using Agency standard
assumptions.  In certain cases where standard values were unavailable,
AD used professional judgment based on Agency understanding of
industrial practices to create estimates. Assumptions for these
scenarios were could be further refined with input from the registrants.

For the preservation of textiles, exposures to handlers during
preparation of dipping solution were assessed assuming a liquid pour or
liquid pump operation associated with automated (large-scale) dipping of
textiles in industrial settings. However, based on the label use
instructions, it is clear that manual dipping is also used for
preservation of textiles (e.g., via preparation of small-scale dipping
solution by pouring product into a small receptacle and manually dipping
textiles). Exposures that may occur as part of manual dipping activity
for textiles are not assessed here and may result in possibly higher
exposures than are estimated for the liquid pour/liquid pump scenarios
associated with large-scale dip operations.  However, since the Agency
assessed dip treatment of wood in this document (i.e., diptank
operators), and the use methods are comparable to those for textile
treatment, that assessment can be considered as a high-end
representative estimate of manual textile dip applications.

The type of spray equipment to be used was not specified on most labels
for scenarios involving preservation of outdoor-use textiles and general
preservation of wood use patterns.  Therefore, these scenarios were
assessed using the PHED unit exposures for use of a low-pressure hand
wand (for outdoor-use textiles), and use of an airless sprayer or a
low-pressure hand wand (for the general preservation of wood). In these
cases, the appropriate application equipment could be further refined by
the registrants. It is noted that by assuming use of an airless sprayer
for preservation of wood products, a higher unit exposure value is
selected and the quantity handled is greater; resulting therefore in
increased handler exposure.

Remedial treatments with Copper Naphthenate can be made to in-service
wooden poles/piles/posts using brush, trowel, caulking gun (mechanical
pressure pump), or impregnated bandage wraps.  In lieu of
chemical-specific data or surrogate data sources for the remedial
applications, handlers applying remedial-use products to
interior/exterior surfaces of in-service poles were assessed using unit
exposure data for the PHED paintbrush scenario (Scenario 22).  As a
high-end conservative approach, it was assumed that the PHED paintbrush
scenario unit exposure value can be used to represent the remedial
brushing techniques.  Exposures for the other application methods (i.e.,
trowel, caulking gun, or pre-manufactured bandage) were assumed to be
represented by the assessment done using unit exposure data for the
brush use scenario.  This approach may overestimate actual exposures for
workers conducting remedial treatments based on the following
considerations:

The brush-on application in treating in-service utility poles is
predominantly used for wood preservative pastes.  Brushing  a semi-solid
onto a pole may not present the same exposures as brushing a liquid (as
in PHED painting scenario) due to differences in the viscosity of the
material being brushed;

The liquid Copper Naphthenate formulations are injected directly into a
pole through a pressure pump to treat the internal areas of a pole. The
exposure to the applicator would be in the mix and load phase of the
application process and not in the actual application to the pole; and

Wrapping a bandage around a pole would not present the same exposures as
brushing a liquid (as in PHED painting scenario).

For the wood preservative pressure treatment scenarios, CCA exposure
data were used in the absence of exposure data specific to the
Naphthenate Salts. For the wood preservative non-pressure treatment
scenarios, DDAC exposure data were used in the absence of more 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 Naphthenate Salts, and therefore
the exposures could be used as surrogate data for workers that treat
wood with Copper/Zinc Naphthenate-based formulations.

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

In the occupational assessment, dermal exposures to treated wood were
estimated using surrogate DDAC data (3 (g/cm2). The degree of
uncertainty (under- or overestimation) associated with using the DDAC
hand residue data for dermal exposure from contacting treated lumber are
unknown. The amount of residue measured on the test subjects’ hands is
variable and may be influenced by the duration of exposure, how often
wood is contacted, and the degree of contact (i.e., with or without use
of glove PPE).

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 naphthenate salts 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
naphthenate salts, are provided in the following table (Table 8.1).

Table 8.1.  Acute Oral Toxicity of Naphthenate Salts 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 Naphthenate 9.55%	LD50 = >2250

NOAEL = <292

	Relatively nontoxic	Yes (core)

- 14-day test duration

- 19 weeks of age	42348601

Bobwhite quail

(Colinus virginianus)	Zinc Naphthenate

14.33%	LD50 = >2250

NOAEL = <175

	Relatively nontoxic	No (supplemental)

- 14-day test duration

- 19 weeks of age

- data not provided to support the NOEL	42348604

These acceptable acute oral toxicity studies on the bobwhite quail
indicate that naphthenate salts are relatively nontoxic 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 naphthenate salts. The preferred-test species is either the
mallard duck or bobwhite quail. The results of four subacute dietary
toxicity studies, submitted for naphthenate salts, are provided in the
following table (Table 8.2).

Table 8.2.  Subacute Oral Toxicity of Naphthenate Salts to Birds

Species

Chemical,

% Active Ingredient

(a.i.)

Tested

Endpoint

(ppm)

Toxicity Category

Satisfies Guidelines/

Comments

Reference

(MRID No.)

Bobwhite quail

(Colinus virginianus)	Zinc Naphthenate

14.33%	LC50 (diet) = >5620

NOAEC = 5620	Relatively nontoxic	Yes (core for TEP)

-	8-day test duration

-	10 days of age	42348605

Mallard duck

(Anas platyrhynchos)	Zinc Naphthenate

14.33%	LC50 (diet) = >5620

NOAEC = 5620	Relatively nontoxic	Yes (core for TEP)

-	8-day test duration

-  10 days of age	42348606

Bobwhite quail

(Colinus virginianus)	Copper Naphthenate

9.55%	LC50 (diet) = >5620

NOAEC = 1780	Relatively nontoxic	Yes (core)

-  8-day test duration

-  10 days of age	42348602

Mallard duck

(Anas platyrhynchos)	Copper Naphthenate

9.55%	LC50 (diet) = >5620

NOAEC = 5620	Relatively nontoxic	Yes (core)

-  8-day test duration

-  10 days of age	42348603

		The results from four acceptable studies indicate that naphthenate
salts are 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 naphthenate salts 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
two freshwater fish acute studies submitted for naphthenate salts, 1
coldwater and 1 warmwater, are presented in Table 8.3.

Table 8.3.  Acute Toxicity of Naphthenate Salts 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 naphthenate

98.9%	LC50 = 3.1

	Moderately toxic	Yes (core)

-	96-hr test duration

-	static renewal test system	42489101

Rainbow Trout (Oncorhynchus mykiss)	Zinc naphthenate

98.9%	LC50 = 1.1

NOAEC = 0.39	Moderately toxic	Yes (core)

-	96-hr test duration

-	static test system	42489102

		Freshwater acute toxicity tests indicate that naphthenate salts are
moderately toxic to fish on an acute basis. Study 42489102 fulfills the
guideline requirement for the coldwater species and study 42489101
fulfills the guideline requirement for the warmwater fish species under
OPPTS 850.1075 (72-1a&b).

			<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 naphthenate salts are provided in the following table
(Table 8.4).

Table 8.4.  Acute Toxicity of Naphthenate Salts 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 Naphthenate

95.6%	EC50 = 0.34

NOAEC = 0.12 	Highly toxic	Yes (core)

-	48-hr test duration

-	static test system 	42489103

		The results of 42489103 indicate that naphthenate salts are 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 naphthenate salts 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 naphthenate salts based on the chemical’s
potential to reach estuarine and marine environments.  No studies have
been submitted to fulfill these data requirements (OPPTS
850.1075/(72-3a), OPPTS 850.1035/(72-3c) and OPPTS 850.1025/(72-3b)).

 		<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.  This testing is required for
naphthenate salts.  No studies have been submitted to fulfill these data
requirements (OPPTS 850.1300, 850.1350, and 850.1400).

8.1.3   Toxicity to Plants

		Non-target plant phytotoxicity testing is required for pesticides when
certain conditions of use and environmental fate apply.  Naphthenate
salts uses 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.

Four algal toxicity tests under 850.5400 are outstanding:  freshwater
green alga (Selenastrum capricornutum), freshwater diatom (Navicula
pelliculosa), blue-green cyanobacteria (Anabeana flow-aquae), and marine
diatom (Skeletonema costatum).  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 naphthenate from a dock into
water.  It was assumed that 4% of the total applied copper naphthenate
would leach from the wood into the water.  An average retention rate of
0.03875 pounds per cubic foot was used.  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 naphthenate EECs were
calculated for water body sizes ranging from 1 acre foot to 24 acre
feet.  The highest EEC of 1.67 mg copper naphthenate per liter of water
was calculated for the smallest body of water (1 acre foot).  For a 6
foot deep water body, the EEC was calculated as 0.278 mg copper
naphthenate per liter of water.  For details on the calculations
conducted to arrive at this and other EECs as well as the uncertainties
and limitations of the calculations, consult Siroos Mostaghimi’s
4/27/2007 memo “Estimated Environmental Concentrations for Copper
Naphthenate from Treated Wood Used to Build DocksMaximum Ecotoxicity
Values:

	In the toxicity tables in section I above, the toxicity of copper
naphthenate to bluegill sunfish (Lepomis macrochirus) is recorded.  The
LC50 value obtained in this study was 3.1 mg/L (MRID 42489101).  The
EC50 value obtained in a study on the freshwater invertebrate (Daphnia
magna) was 0.34 mg/L (MRID 42489103).  There were no acceptable acute
toxicity studies for estuarine and marine organisms nor were there any
acceptable chronic toxicity studies available for aquatic organisms.
There were also no studies available for aquatic plants. Therefore, risk
to these species cannot be assessed.

Acute Freshwater Fish LOC’s:

	Comparing the maximum calculated Expected Environmental Concentration
of 1.67 mg/L in one acre-inch of water to the toxicity found in the fish
acute study (3.1 mg/L), an RQ of 0.54 is obtained.  This is greater than
the LOCs for acute risks to aquatic animals (0.5) and acute endangered
species risks (0.05).  Therefore, there is the potential for copper
naphthenate to cause adverse effects to freshwater fish and these risks
may need to be mitigated.  The calculated EEC for a larger body of water
(6 acre feet) is 0.278 mg copper naphthenate per liter of water.  This
EEC brings the RQ for freshwater fish down to 0.09, which is lower than
all LOCs for aquatic organisms except for the endangered species LOC.
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 (0.34 mg/L), an RQ of 4.91 is
obtained.  This is greater than all LOCs for aquatic organisms.
Therefore, there is the potential for copper naphthenate to cause
adverse effects to freshwater invertebrates and these risks may need to
be mitigated.  The calculated EEC for a larger body of water (6 acre
feet) is 0.278 mg copper naphthenate per liter of water.  This EEC
brings the RQ for the freshwater invertebrate down to 0.82 so the risks
to freshwater invertebrates remain.  However, as discussed below an
endangered species effect determination will not be made at this time.

Acute Aquatic Estuarine/Marine Species:

		Three acute estuarine/marine ecotoxicity studies are required (one
fish, one shrimp, one bi-valve), however, no data are available for
copper naphthenate.  This risk assessment is incomplete.

Chronic Aquatic Toxicity Studies:

		Chronic freshwater fish and invertebrate studies are triggered based
on acute toxicity.  No studies are available for copper naphthenate.
Estuarine/marine chronic toxicity studies for fish and invertebrates are
reserved pending results of acute toxicity tests.  This risk assessment
is incomplete.

Plant Toxicity Studies:

	No aquatic or terrestrial plant toxicity studies are available for
copper naphthenate.  This risk assessment is incomplete.

Avian and Mammalian Species:

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

	8.2	Environmental Fate Assessment

	Copper naphthenate is very stable substance in water under aerobic and
abiotic conditions, with an estimated half-life of more than three
months.  It is highly to moderately immobile in soils with an estimated
Koc of over 3000.  It is not highly water soluble and has a high vapor
pressure (~ 10-4 mm Hg) and air/water partition coefficient (estimated
Henry Law Constant for copper naphthenate is ~ 9.804x 10-6).  Therefore
copper naphthenate is likely to evaporate from water surfaces as well as
contaminate surface water through soil run-off.  Copper naphthenate is
likely to persist in water and soils.  The estimated log Kow for copper
naphthenate is 4.1685, which indicates that copper naphthenate can
possibly bioaccumulate in aquatic organisms like fish.  The estimated
half-life in air is 8.858 hours (measured against the hydroxyl radical)
and it is not likely to be persistent in air.  A laboratory study on
southern yellow pine stakes has shown that copper naphthenate does leach
from pressure and surface treated wood.

Zinc naphthenate, like copper naphthenate, is likely to be a stable
substance in water under aerobic and abiotic conditions, with an
estimated half-life of more than three months.  It is also likely to be
highly to moderately immobile in soils with an estimated Koc of over
3000. It is not highly water soluble and has a high vapor pressure (~
10-4 mm Hg) and air/water partition coefficient (estimated Henry Law
Constant for copper naphthenate is ~ 9.804x 10-6).  Therefore zinc
naphthenate, like copper naphthenate, is likely to evaporate from water
surfaces and contaminate surface water through soil run-off.  Zinc
naphthenate is also likely to persist in water and soils.  The estimated
log Kow for zinc naphthenate is possibly similar to that of copper
naphthenate (4.1685).  This indicates that zinc naphthenate can possibly
bioaccumulate in aquatic organisms like fish.  The estimated half-life
of copper naphthenate in air is 8.858 hours and zinc naphthenate is
likely to have a similar value and is not likely to be persistent in
air.  A laboratory study on southern yellow pine stakes has shown that
zinc naphthenate does leach from surface and pressure treated wood.
Because of a high Koc  zinc naphthenate is likely to contaminate surface
soils around treated wood.

Considering the above, the following studies are required to better
determine the bioaccumulation potential of naphthenate salts and to
quantify leaching amounts from treated wood:  fish bioconcentration
study (850.1730); and aqueous leaching study (AWPA E11-06).
Additionally, an environmental runoff monitoring study (guideline no.
none) is required unless wood preservative labels are modified to
include the restrictions outlined above.

8.3	Environmental Exposure and Ecological Risk Assessment

EPA has performed an environmental risk assessment using estimated
environmental concentrations (EECs) for naphthenate salts developed by
modeling copper naphthenate’s release from a dock into water and
toxicity values from the tables in section 8.1 to develop risk quotients
(RQs) and compare them to levels of concern (LOCs).  LOCs were exceeded
for freshwater fish and freshwater invertebrates in bodies of water 6
acre feet in size; however, as discussed below an endangered species
effects determination will not be made at this time.  There were no
acute toxicity studies available for estuarine and marine organisms nor
were there any acceptable chronic toxicity studies available for aquatic
organisms.  There were also no studies available for aquatic plants.
Therefore, risk to these species could not be assessed.  Modeling was
not conducted for zinc naphthenate, but environmental exposures are
assumed to be similar to those for copper naphthenate.

	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 active ingredient uses of
naphthenate salts for material preservative uses fall into this
category.

	For the wood treatment uses, this preliminary analysis indicates that
there is a potential for naphthenate salts 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 naphthenate salts 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, fish bioconcentration) lacking; such data would be useful in
refining this preliminary risk assessment.

	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

Naphthenate Salts (Copper and Zinc):

Acute aquatic invertebrate study (850.1010) (zinc naphthenate),

Estuarine/marine fish acute study (850.1075) (both copper and zinc
naphthenate),

Estuarine/marine shrimp acute study (850.1035) (both copper and zinc
naphthenate),

Estuarine/marine mollusk acute study (850.1025) (both copper and zinc
naphthenate),

Acute sediment toxicity to freshwater invertebrates (850.1735) (both
copper and zinc naphthenate),

Acute sediment toxicity to estuarine invertebrates (850.1740) (both
copper and zinc naphthenate),

Fish bioconcentration study – BCF (850.1730) (both copper and zinc
naphthenate),

Aquatic invertebrate (freshwater) life-cycle study (850.1300) (both
copper and zinc naphthenate),1

Fish early life-stage (freshwater) study (850.1400) (both copper and
zinc naphthenate),1

Fish early life-stage (estuarine/marine) study (850.1400) (both copper
and zinc naphthenate),1

Chronic mysid shrimp study (850.1350) (both copper and zinc
naphthenate),1

Freshwater green alga (850.5400) (both copper and zinc naphthenate),

Freshwater diatom (850.5400) (both copper and zinc naphthenate),

Blue-green cyanobacteria (850.5400) (both copper and zinc naphthenate),

Marine diatom (850.5400) (both copper and zinc naphthenate),

Freshwater floating macrophyte duckweed (850.4400) (both copper and zinc
naphthenate),

Freshwater rooted macrophyte rice seedling emergence (850.4225) (both
copper and zinc naphthenate),

Freshwater rooted macrophyte rice vegetative vigor (850.4250) (both
copper and zinc naphthenate),

Wood leaching study (AWPA E11-06) (both copper and zinc naphthenate),

Environmental runoff monitoring study (None) (both copper and zinc
naphthenate).  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/zinc naphthenate shall
not be used in the construction of beehives.” (both copper and zinc
naphthenate).

9.0	INCIDENT REPORTS

The Agency reviewed the following information for human poisoning
incidents related to naphthenate salt 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).
(5) Published Scientific Literature on Incidences

	Since 1992, only one incident associated with copper or zinc
naphthenate, alone or in combination has been recorded where a strong
odor was noticed and adverse health effects reported following
residential application of copper naphthenate containing wood
preservative. However, no clear symptoms were described in the report.
Some incidences associated with exposure to end-use products containing
copper and/or zinc naphthenates have been reported. Although
naphthenates are skin irritants in man and in rabbits, not many skin
related incidences have been reported.  Itchy rashes are the primary
reported complaints through dermal exposure.  Inhalation of vapors of
pesticides containing copper naphthenate have been reported to cause
nausea, head ache, dizziness, sore throat, dry throat, chest tightness
and coughing. It is not known if symptoms reflected exposure to
naphthenate, the solvent vehicle, volatilized copper, or the stress of
exposure to a strong odor compound perceived as toxic.

The most common symptoms reported for cases of ocular exposure were eye
irritation/burning.  Eye pain and swelling of eyes also been reported in
some cases. No exposure incidences associated with oral exposure have
been reported.

10.0	REFERENCES

Toxicology References

00244277	 Bioresearch, Inc. (1980): Acute Oral Toxicity Study. Project
#:80-2171A.

00244277	 Bioresearch, Inc. (1980): Acute Dermal Toxicity Study. Project
#:80-2171A.

00244277		 Bioresearch, Inc. (1980): Acute Inhalation Toxicity Study.
Project #:80-2171A.

00244277	 Bioresearch, Inc. (1980): Eye Irritation Study. Project
#:80-2171A.

00244277	 Bioresearch, Inc. (1980): Dermal Irritation Study. Project
#:80-2171A.

00244277	 Bioresearch, Inc. (1980): Dermal Sensitization Study. Project
#:80-2171A.

00260891	 Applied Biological Sciences Laboratory, (1975): Study # 2778.

00266172	 Cannon Laboratories, Inc. (1980): Acute Oral Toxicity. Project
#: OF-7374.

41140710	Angerhofer, R.A. and L.W. Metger:  Phase 3 Preliminary
Assessment of the     Relative Toxicity of Copper Naphthenate. Acute
Studies: Acute Oral and Dermal Toxicity Studies.

41140710	Angerhofer, R.A. and L.W. Metger:  Phase 3 Preliminary
Assessment of the Relative Toxicity of Copper Naphthenate. Acute
Studies: Primary Skin Irritation and Dermal Sensitization Studies.

41400701	Harbell, J.W. (1990): L5178Y TK Mouse Lymphoma Mutagenesis
Assay with Confirmation.  Test Article Zinc Naphthenate.
Microbiological Associates, Inc, Rockville, MD. Study No. T9036.701.

41400702	Putnam, D.L. and Morris. M.J. (1990): Chromosome Aberrations in
Chinese Hamster Ovary (CHO) Cells. Test Article Zinc Naphthenate.
Microbiological Associates, Inc, Rockville, MD. Study No. T9036.337.

41400703	Curren, R.D. (1989): Unscheduled DNA Synthesis in Rat Primary
Hepatocyte. Test Article Zinc Naphthenate. Microbiological Associates,
Inc, Rockville, MD. Study No. T9036.380.

41402502	Harbell, J.W. (1990): L5178Y TK Mouse Lymphoma Mutagenesis
Assay with Confirmation. Test Article Copper Naphthenate.
Microbiological Associates, Inc, Rockville, MD. Study No. T9037.701.

41402503	Putnam, D.L. and Morris. M.J. (1990): Chromosome Aberrations in
Chinese Hamster Ovary (CHO) Cells. Test Article Copper Naphthenate.
Microbiological Associates, Inc, Rockville, MD. Study No. T9037.337.

41402504	Curren, R.D. (1989): Unscheduled DNA Synthesis in Rat Primary
Hepatocyte.  Test Article Copper Naphthenate.  Microbiological
Associates, Inc, Rockville, MD. Study No. T9037.380.

41486301	Collins, C.J. (1990): Acute Inhalation Toxicity Study – LC50
Rats (4 hour exposure).Hazleton UK. Study Number HUK 769/1.

41615001	Tompkins, E.C. (1990): 90-Day Dermal Study in Rabbits with Zinc
Naphthenate. WIL Research Laboratories, Ashland Ohio, Study No.
WIL-153006.

41615002	Nemec, Marc D. (1990): A Developmental Toxicity Study of Zinc
Naphthenate in Rats.  WIL Research Laboratories, Ashland Ohio, Study No.
WIL-153004.

41615101	Nemec, Marc D. (1990): A Developmental Toxicity Study of Copper
Naphthenate in Rats.  WIL Research Laboratories, Ashland Ohio, Study No.
WIL-153002.

41676101	Tompkins, E.C. (1990): 90-Day Dermal Study in Rats with Copper
Naphthenate.                     WIL Research Laboratories, Ashland
Ohio, Study No. WIL-153012.

No MRID	Michie, M., Angerhofer, M., Barlow, M. (1988): Phase 5 Effects
of ingestion of zinc naphthenate on the reproductive function of rats.
Toxicological study no. 75-51-0497-91. U.S. Army Environmental Hygiene
Agency. Laboratory report 75-51-0497-91.

No MRID	Angerhofer, R., M. Michie, M. Barlow, et al. (1991) Phase 4,
toxicological study no. 75-51 0497-91, assessment of the developmental
toxicity of zinc naphthenate in rats, June 1985 – July 1988. U.S. Army
Environmental Hygiene Agency. Laboratory report number 75-51-0497-91.

Open Literature

Kishiyama and Gee. (2000). California Environmental Protection Agency
Department of Pesticide Regulation Mede3ical Toxicology Branch.  Summary
of Toxicology Data. Copper Naphthenate and Zinc Naphthenate.

Environmental Fate References

43851101	Copper Naphthenate Leachability From Treated Wood, A
Non-Guideline Study for the AD Fate Data Requirements 1995, by A.C.
Gallacher. Dept. of Analytical Services, Ricerca, Inc. 7528 Auburn Rd.;
PO Box 1000, Painesville, Ohio, 44077-1000.

44095101	Zinc Naphthenate Leachability From Treated Wood, A
Non-Guideline Study for the AD Fate Data Requirements 1996, by A.C.
Gallacher. Dept.of Analytical Services, Ricerca, Inc. 7528 Auburn Rd.;
PO Box 1000, Painesville, Ohio, 44077-1000.

Open Literature

Clemente, J.S., M.D. Mackinnon, and P.M. Fedorak. (2004). Aerobic
Biodegradation of Two Commercial Naphthenic Acids Preparations. MRID to
be assigned. Environ. Sci.

 	Technol, 38:1009-1016.

Headley, J.V. and D. W. McMartin. (2004). A Review of the Occurrence and
Fate of Naphthenic Acids in Aquatic Environments. Journal of
Environmental Science and Health, A39(8):1989 2010

Ken L. Harp and Scott L. Grove, 1993: “ Evaluation of Wood and Soil
Samples From Copper Naphthenate-Treated Utility Poles in Service”,
Proceedings of  the Annual Meeting of: American Wood Preservers’
Association, Volume 89, pp 167-191

McMartin, D.W., J. V. Headley., D. A. Friesen et al. (2004). Photolysis
of Naphthenic Acids in Natural Surface Water.  Journal of Environmental
Science and Health, A39(6): 1361-1383

Quagraine, E.K., J. V. Headley and H.G. Peterson. (2005). Is
Biodegradation of Bitumen a Source of Recalcitrant Naphthenic Acid
Mixtures in Oil Sands Tailing Pond Waters?

	 Journal of Environmental Science Health, 40:671-684.

Stan Lebow, 1996. “ Leaching of Wood Preservative Components and Their
Mobility in the Environment.” United States Department of Agriculture,
Forest Product Laboratory , General Technical Report FPL-GTR-93.

Product Chemistry References

40317001	Mooney Chemicals, Inc. (1985) Product Chemistry: Zinc
Naphthenate-Wood Preservative. Unpublished study. 6 p.

40698401		Thomas, G. (1988). Product Chemistry: Zinc Naphthenate-Wood

Preservative: M-GARD S562L. Unpublished study prepared by Mooney
Chemicals, Inc. 6 p.

40996501	West, M. (1989). Product Chemistry for Chapco Z Nap 8-0.
Unpublished study prepared by Chapman Chemical Co. 11 p.

40996503	West, M. (1989). Product Chemistry for Chapco Z Nap 8-0.
Unpublished study prepared by Chapman Chemical Co. 4 p

42118901	Grove, S. (1990). Technical Grade Zinc Naphthenate-Product
Chemistry: Physical and Chemical Characteristics: Lab Project Number:
F-24044-P. Unpublished study prepared by Mooney Chemicals, Inc. 20 p.

Ecotoxicity References

42348601  	Campbell, S.; Lynn, S. (1992) Copper Naphthenate: An Acute
Oral Toxicity Study with the Northern Bobwhite: Lab Project Number:
324-101.  Unpublished study prepared by Wildlife International, Ltd.
32p.

42348602  	Campbell, S.; Grimes, J.; Lynn, S. (1992) Copper Naphthenate:
Acute Avian Dietary Toxicity (LC50) in Bobwhite Quail: Lab Project
Number: 324-102.  Unpublished study prepared by Wildlife International,
Ltd. 45p.

42348603 	 Campbell, S.; Grimes, J.; Lynn, S. (1992) Copper Naphthenate:
Acute Avian Dietary Toxicity (LC50) in Mallard Ducks: Lab Project
Number: 324-103.  Unpublished study prepared by Wildlife International,
Ltd. 46p.

42348604  	Campbell, S.; Lynn, S. (1992) Zinc Naphthenate: An Acute Oral
Toxicity Study with the Northern Bobwhite: Lab Project Number: 324-104.
Unpublished study prepared by Wildlife International, Ltd. 32p.

42348605  	Campbell, S.; Grimes, J.; Lynn, S. (1992) Zinc Naphthenate: A
Dietary LC50 Study with the Northern Bobwhite: Lab Project Number:
324-105.  Unpublished study prepared by Wildlife International, Ltd.
45p.

42348606  	Campbell, S.; Grimes, J.; Lynn, S. (1992) Zinc Naphthenate: A
Dietary LC50 Study with the Mallard: Lab Project Number: 324-106.
Unpublished study prepared by Wildlife International, Ltd. 46p.

42489101 	 Collins, M. (1992) Copper Naphthenate: Acute Toxicity to
Bluegill Sunfish (Lepomis macrochirus) under Static Renewal Conditions:
Final Report: Lab Project Number: 92-3-4147: 11582.0591.6107.100.
Unpublished study prepared by Springborn Labs, Inc. 59p.

42489102  	Collins, M. (1992) Zinc Naphthenate: Acute Toxicity to
Rainbow Trout (Oncorhynchus mykiss) under Static Conditions: Final
Report: Lab Project Number: 92-3-4154: 11582.0591.6104.103.  Unpublished
study prepared by Springborn Labs, Inc. 56p.

42489103  	Collins, M. (1992) Copper Naphthenate: Acute Toxicity to
Daphnids (Daphnia magna) under Static Conditions: Final Report: Lab
Project Number: 92-2-4096: 11582.0591.6106.110.  Unpublished study
prepared by Springborn Labs, Inc. 58p

Incident Report References

Bluhm, R.E.; Welch, L.; and Branch, R.A. 1992. Increased Blood and Urine
Copper After Residential Exposure to Copper Naphthenate. J Toxicol Clin
Toxicol 30 (1): 99-108

Occupational Residential Exposure Assessment References

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).

  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.

Naphthenate Salts Research Task Force (NSRTF). 2007. Documents submitted
to the Agency outlining NSRTF Registrants supported uses for
Reregistration of Copper Naphthenate and Zinc Naphthenate. NSRTF. Dated
January 29, 2007 and February 24, 2007.

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

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

U.S. Environmental Protection Agency (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.

U.S. Environmental Protection Agency (USEPA).  1999.  Evaluation of
Chemical Manufacturers Association Antimicrobial Exposure Assessment
Study.  Memorandum from Siroos Mostaghimi, Ph.D., USEPA, to Julie
Fairfax, USEPA. Dated November, 4 1999.  DP Barcode D247642.

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

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

U.S. Environmental Protection Agency (USEPA).  2003.  Assessment of the
Proposed Bardac Wood Preservative Pressure Treatment Use.  Memorandum
from Tim Leighton and Siroos Mostaghimi.  February 11, 2003.

U.S. Environmental Protection Agency (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.

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

U.S. Environmental Protection Agency (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.).

U.S. Environmental Protection Agency (USEPA). 2006a. Registration
Division (RD) Action Memorandum. Reassessment of the One Exemption from
the Requirement of a Tolerance for Copper Naphthenate (CAS Reg. No.
1338-02-9).  Memorandum from Pauline Wagner, Chief, Inert Ingredient
Assessment Branch, RD. June 27, 2006.

U.S. Environmental Protection Agency (USEPA). 2006b. Meeting Minutes of
SMART Meeting for Naphthenate Salts. Reregistration Case 3099. November
6, 2006.  Transmittal from K. Avivah Jakob, Chemical Review Manager,
USEPA to Copper/Zinc Naphthenate RED Team Members, USEPA. Dated December
11, 2006.

U.S. Environmental Protection Agency (USEPA). 2007.   Review Memorandum:
Naphthenate Salts (Zinc/Copper) – Endpoint Selection Report from T.F.
McMahon, Ph.D., Senior Toxicologist, AD. April 16, 2007.

U.S. Environmental Protection Agency (USEPA).  2007a. Review Memoranda:
Environmental Fate Transport Assessments for Zinc Naphthenate and Copper
Naphthenate for Reregistration Eligibility Decision (RED). Two documents
from A. Najm Shamim, Ph.D., Chemist, AD. Dated February 20, 2007 and May
9, 2007 respectively.

Websites/Databases

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.

Hazardous Substances Data Bank (HSDB).  2007.    HYPERLINK
"http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB"
http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB .  Last viewed May
2007.  Data on molecular weight cited in HSDB to:  NIOSH; Information
Profiles on Potential Occupational Hazards: Copper and Compounds.
Contract No 210-79-0030, Rockville, MD: NIOSH, 2nd Draft (1982).  Data
on vapor pressure cited in HSDB to:  Tomlin, C.D.S. (ed.). The Pesticide
Manual - World Compendium, 11th ed., British Crop Protection Council,
Surrey, England 1997, p. 859.

SIMetric.  2007.  Mass, Weight, Density, or Specific Gravity of Bulk
Materials.    HYPERLINK "http://www.simetric.co.uk/si_materials.htm"
http://www.simetric.co.uk/si_materials.htm , last accessed May 2007.

EPI Suite (version 3.12)

Supporting Documentation

California Environmental Protection Agency, Department of Pesticide
Regulation (DPR). 2000.

	Notice of Final Decision Concerning Reevaluation of Pesticide Products.
 California Notice 2000-5.  Posted Date May 8, 2000.

Health Canada. Pesticide Management Regulatory Agency (PMRA).  1992.
Regulatory Notice. Label Improvement Program.  Mercury In-Can Paint
Preservatives and Copper and Zinc Naphthenate Wood Preservatives. Note
to CAPCO. C92-07. December 22, 1992.

APPENDIX A

Toxicity Profile for Copper and Zinc Naphthenate

Table 3.3 Subchronic, Chronic and Other Toxicity Profiles Table (Tables
a and b)

Table 3.3 a. Subchronic, Chronic, and other Toxicity Profiles for Copper
Naphthenate.

Guideline Number/

Study Type/

Test Substance (% a.i.)	MRID Number (Year)/

Citation/

Classification/ Doses

Results

870.3250

90-day dermal (rat)

Purity: 9.5% Copper	MRID 41676101

Tompkins, E.  (1990)

Acceptable – Core-Minimum

Copper naphthenate administered dermally at 0, 100, 300, or 1000
mg/kg/day for 13 weeks

10 G. Pigs/sex/dose, 6 hrs/day, 5 days/week for 13 weeks

	Dermal Toxicity:

NOAEL:  = 100 mg/kg/day

LOAEL:  = 300 mg/kg/day, no apparent dose related increases in
macroscopic and microscopic lesions related to dermal irritation.

Systemic Toxicity:

NOAEL: >= 1000 mg/kg/day

LOAEL:  > 1000 mg/kg/day, based on a decrease in body weight gain and
food efficiency in the high dose males along with an increase in kidney
weight and a decrease in testes weight.

870.3700a

Developmental Toxicity – (rat)

Purity: 9.5% Copper	MRID 41615101

Nemec, Mark D. (1990)

Acceptable – Guideline

Copper naphthenate administered orally at 0, 30, 100, or 300 mg/kg/day
from days 6-15 of gestation.

25 female rats/dose

	Maternal Toxicity:

NOAEL:  > 30 mg/kg/day

LOAEL:  >=  300 mg/kg/day, based on a decrease in body weight gain and
food consumption.

Developmental Toxicity:

NOAEL: >= 300 mg/kg/day

LOAEL: >    300 mg/kg/day. There were no treatment-related effects on
fetal endpoints.

870.5140

Gene mutation test in mouse lymphoma cells

Purity: Not reported	MRID 41402502

Harbell, J.  (1990) L5178Y  TK+/- Mouse Lymphoma Mutagenesis Assay with
Confirmation. Microbiological Associates, Inc. Rockville, MD. Study #:
T9037.701

Copper naphthenate administered at:

Nonactivated

1. Confirmatory test: 7.5, 11, 15, 19, 23, 27, 30, 33, 36, 40, 44, and
75 ug/ml

S9Activated

2. Confirmatory test: 7.5, 11, 15, 19, 23, 27, 30, 33, 36, 40, 44, and
75 ug/ml

Strain: mouse lymphoma L5178Y cells

Unacceptable – upgradable

	Negative

Copper naphthenate in the absence of S9 activation was cyrotoxic at
doses approximately ≥36 ug/ml but was not mutagenic over a
concentration range of ~4.2-36 ug/ml in two independently performed
forward gene mutation mouse lymphoma assays. In the presence of S9
activation at concentrations of  18, 24, 32, and 42 ug/ml (initial
assay) and 23,27, 30, 33, and 36 ug/ml +S9 (confirmatory assay ),
dose-related increases in the number of mutant colonies and the mutation
frequency (MF) at the thymidine kinase locus was observed . The increase
in mutation over background ranged from a 1.4-fold at 18 ug/ml to a
3.4-fold at 42 ug/mL.  Copper naphthenate also produced large- and
small-colony trifluro-thymidine (TFT)—resistant mutants at the dose
levels selected to evaluate colony-size distribution (24, 32, and 42
ug/ml - - initial trial and 30, 33, and 36 ug/ml - - confirmatory
trial).  However, the evidence suggesting that copper naphthenate may
also be clastogenic was neither confirmed nor refuted in the CHO cell
clastogenic study conducted with the same batch number of the test
material.   Copper naphthenate is positive for mutagenicity in this test
system.

870.5385

Cytogenetics assay in CHO cells

Purity: Not reported	MRID 41402503

Putnam, DL and Morris, MJ  (1990) Chromosome Aberrations in CHO Cells
Test Article Copper Naphthenate. Microbiological Associates, Inc.
Rockville, MD, Lab Project #: T9037.337.

 Nonactivated  concentrations:

Trial 1: 4, 8, 15, 30, and 60 ug/ml (16-hr cell harvest)

Trial 2: 40, 80, 120, and 160 ug/ml (16-hour cell harvest)

Activated concentrations:

Trial 1: 2, 4, 8, 15, and 30 ug/ml (12-hour cell harvest)

Trial 2: 20, 30, 40, 50, and 60 ug/ml (12-hour cell harvest)

Trial 3: 40, 60, 80, 120, 160, and 200 ug/ml (12-hour cell harvest)

Strain: CHO-K1 cells

Unacceptable – not upgradable

Although the test material did not induce reproducible significant
increases in the frequency of structural chromosome aberrations, there
was a consistent trend of increased abnormal chromosome morphology,
particularly at the high dose scored in each S9-activated trial (30
ug/mL - -Trial 1; 60 ug/mL - - Trial 2; and 80 ug/mL- - Trial 3).

No definitive conclusions can be reached regarding mutagenicity of
copper naphthenate in this test system.

870.5550

UDS in mammalian cells in culture

Purity: Not reported	MRID 41402504

Curren, RD (1989) Unscheduled DNA Synthesis in Rat Hepatocytes. Test
Article Copper Naphthenate. Microbiological Associates, Inc. Rockville,
MD, Lab Project #: T9036.380.

Concentrations tested:

Preliminary cytotoxicity assay: 0.135, 0.45, 1.35, 4.5, 13.5, 45, 135,
450, 1350, and 4500 ug/ml.

UDS assay:

0.05, 0.15, 0.5, 1.5, 5.0, 15, 35, and 50 ug/ml.

Unacceptable –  upgradable

Copper naphthenate at five concentrations ranging from 0.15 to 15 ug/ml
did not induce unscheduled DNA synthesis (UDS) in primary rat
hepatocytes.   Information on the purity of the test material  must be
provided to upgrade the study.  Copper naphthenate is negative in this
test system.

Table 3.3 b. Subchronic, Chronic and other Toxicity Profiles for Zinc
Naphthenate

Guideline Number/

Study Type/Test Substance (% a.i.)	MRID Number (Year)/
Citation/Classification/ Doses

Results

870.3200

dermal (rat)

14-day dermal (rabbit)

Purity: not given	Muni, IA et al. (1983). US Army Medical Research and
Development Command, Fort Detrick, Frederick, MD 21701. Contract #:
DAMD17-82-C-2301.

Zinc naphthenate administered dermally at 0, 9, 30, 100, 500, 2000
mg/kg/day   for 6 hr/day, 5 days/wk for 2 wks.

BIBRA Toxicity profile

unacceptable	Occluded application of  zinc naphthenate for 6 hours/day,
five days/week for 2 weeks to groups of ten rabbits (strain not
specified) at doses of 9, 30, 100, 500, and 2000 mg/kg resulted in
lethargy, diarrhea, reduced food intake and reduced body weight,
distended intestines and fatty changes in the liver at 9 mg/kg/day and
above. Deaths were reported at 9-100 mg/kg/day but not at 500-2000
mg/kg/day.

870.3250

90-day dermal (rat)

Purity: 14.5% Zinc	MRID 41615001

Tompkins, E.  (1990) 90-Dermal Study in Rabbits with Zinc Naphthenate.
WIL Research Labs. WIL/153006. 442 p.

Zinc naphthenate administered dermally at 0, 100, 300, or 1000 mg/kg/day
for 13 weeks

10 Rabbits/sex/dose, 6 hrs/day, 5 days/week for 13 weeks

Purity: 14.5% Zinc

Acceptable – Core-Minimum	Dermal Toxicity:

NOAEL:  < 100 mg/kg/day

LOAEL:  <=100 mg/kg/day, no apparent dose related increases in
macroscopic and microscopic lesions related to dermal irritation.

Systemic Toxicity:

NOAEL: 100 mg/kg/day

LOAEL:  300 mg/kg/day, based on a decrease in body weight gain in males
and females.

No treatment related clinical signs of systemic toxicity were noted
(hematology, clinical chemistry or histopathology).  In terms of dermal
effects there were apparent dose related increases in macroscopic and
microscopic lesions related to dermal irritation.

870.3700

Developmental Toxicity – oral gavage (rat)

Purity: 100% assumed

	MRID 41615002

Nemec, Mark D. (1990) A Developmental Toxicity Study of Zinc Naphthenate
in Rats.  Study No. WIL-153004. (Unpublished study WIL Research Labs,
Ashland, Ohio)

Zinc naphthenate administered orally at 0, 50, 250, or 500 mg/kg/day
from days 6-15 of gestation.

25 female rats/dose	Maternal Toxicity:

NOAEL:  >= 500 mg/kg/day

LOAEL:  >   500 mg/kg/day, there were no treatment-related effects on
maternal endpoints.

Developmental Toxicity:

NOAEL: >= 500 mg/kg/day

LOAEL: >   500 mg/kg/day. There were no treatment-related effects on
fetal endpoints.

Table 3.3 b. Subchronic, Chronic and other Toxicity Profiles for Zinc
Naphthenate

Guideline Number/

Study Type/Test Substance (% a.i.)	MRID Number (Year)/
Citation/Classification/ Doses

Results

870.3700

Developmental Toxicity- rat

Purity: unknown

	Angerhofer, RA (1991): Assessment of  the developmental toxicity of
zinc naphthenate in rats. Phase 4 report No. USAEHA-75-51-0487-91.
AD-A235 308. US Army Environmental Hygiene Agency.

Open literature- BIBRA	Oral administration of zinc naphthenate at doses
of  94, 188, and 938 mg/kg/day to rats during the major period of fetal
organogenesis did not produce any teratogenic effects. Maternal toxicity
in the form of lethargy and lower body weight gain was observed at 938
mg/kg/day. No other information was available on this study.

870.3800

2-generation reproductive toxicity in diet (rat)

Purity: not given

	Michie, MW et al. (1983). Effects of ingestion of zinc naphthenate on
the reproductive function of rats.  Phase 5. Rpt #:
USAEHA-75-51-0487-91.  AD-A235 224.  US Army Env Hygiene Agency. APG, MD

Zinc naphthenate administered orally over 2 generations at 250 mg/kg/day
for an undisclosed time

Rats

Purity: not given

Open-literature (BIBRA)

Mating performance and offspring viability were apparently unaffected
over two generations when rats were fed about 250 mg/kg for an
undisclosed time.

870.5300

In Vitro mammalian cell gene mutation test

Purity: Not reported	MRID 41400701

Harbell, J.W.  (1990) L5178Y TK Mouse Lymphoma Mutagenesis Assay with
Confirmation. Test Article Zinc Naphthenate Microbiological Associates,
Inc. Rockville, MD, Lab Project #: T9036.701.

Nonactivated concentrations:

1. Confirmatory test: 7.5, 11, 15, 19, 23, 27, 30, 33, 36, 40, 44, and
48 ug/ml

S9Activated

2. Confirmatory test: 23, 27, 30, 33, 36, 40, 44, 48, 52, 56, 65 and 75
ug/ml

Strain: mouse lymphoma L5178Y cells

	Mutagenicity observed in two independently performed forward gene
mutation assays. Increases in mutant colonies were
concentration-related. Under non-activated conditions, increases in
mutant colonies ranged from 2.0 fold at 23 µg/ml to 7.2 fold at 42
µg/ml. Under S9 activated conditions, increases in mutant colonies
ranged from 1.7 fold at 32 µg/ml to 4.8 fold at 56 µg/ml.  Zinc
naphthenate also induced formation of small-colony TFT-resistant mutants
in both the absence and presence of metabolic activation. Zinc
naphthenate is classified as a positive mutagen in this test system.
Information on test material purity must be provided

Table 3.3 b. Subchronic, Chronic and other Toxicity Profiles for Zinc
Naphthenate

Guideline Number/

Study Type/Test Substance (% a.i.)	MRID Number (Year)/
Citation/Classification/ Doses

Results

	Unacceptable -upgradable	to upgrade the study.

870.5380

Cytogenetics assay using CHO cells

Purity: Not reported	MRID 41400702

Putnam, DL and Morris, MJ (1990) Chromosome Aberrations in CHO Cells
Test Article Zinc Naphthenate. Microbiological Associates, Inc.
Rockville, MD, Lab Project #: T9036.337.  30 p.

Zinc naphthenate administered at:

Nonactivated

Trial 1: 5, 10, 20, 40, and 80  ug/ml (20-hr cell harvest)

Trial  2: 80, 110, 140, 170, and 200 ug/ml (20-hour cell harvest)

Activated

Trial 1: 10, 20, 40, 80, and 160 ug/ml (20-hour cell harvest)

Trial 2: 60, 80, 100, 120, and 140 ug/ml (20-hour cell harvest)

Strain: CHO-K1 cells

Unacceptable – upgradable

In two independently performed assays, zinc naphthenate induced a
clastogenic response in CHO cells. Chromatid-type aberrations were the
most frequently scored abnormal figures. Zinc naphthenate is positive
for clastogenicity in this test system.  Information on test article
purity must be provided to upgrade this study.

870.5550

UDS in primary rat hepatocytes

Purity: Not reported	MRID 41400703

Curren, RD (1989) Unscheduled DNA Synthesis in Rat Hepatocytes.
Microbiological Associates, Inc. Rockville, MD, Lab Project #:
T9036.380.  28 p.

Concentrations:

Preliminary cytotoxicity assay:

0.05, 0.15, 0.5, 1.5, 5.0, 15, 50, 150, 500, and 1500 ug/ml

UDS assay:

0.15, 0.5, 1.5, 5.0, 15, and 35 ug/ml

Unacceptable – upgradable

Zinc naphthenate at concentrations ranging from 0.15 µg/ml to 15 µg/ml
failed to induce unscheduled DNA synthesis in primary rat hepatocytes.
Zinc naphthenate is negative in this test system.  Information on test
article purity must be provided to upgrade the study.

APPENDIX B:

Summary of CMA and PHED Data

Chemical Manufacturers Association (CMA) Data:

In response to an EPA Data Call-In Notice, a study was undertaken by the
Institute of Agricultural Medicine and Occupational Health of The
University of Iowa under contract to the Chemical Manufacturers
Association.  In order to meet the requirements of Subdivision U of the
Pesticide Assessment Guidelines (superseded by Series 875.1000-875.1600
of the Pesticide Assessment Guidelines), handler exposure data are
required from the chemical manufacturer specifically registering the
antimicrobial pesticide.   The applicator exposure study must comply
with the assessment guidelines for “Applicator Exposure Monitoring”
in Subdivision U and the “Occupational and Residential Exposure Test
Guidelines” in Series 875.  For this purpose, CMA submitted a study on
February 28, 1990, entitled "Antimicrobial Exposure Assessment Study
(amended on December 8, 1992)" which was conducted by William Popendorf,
et al..  It was evaluated and accepted by the Occupational and
Residential Exposure Branch (OREB) of Health Effect Division (HED),
Office of Pesticide Programs (OPP) of EPA in 1990.  The purpose of this
CMA study was to characterize exposure to antimicrobial chemicals in
order to support pesticide reregistrations (CMA, 1992).  The unit
exposures presented in the most recent EPA evaluation of the CMA
database (USEPA, 1999) were used in this assessment.

The Agency determined that the CMA study had fulfilled the basic
requirements of Subdivision U - Applicator Exposure Monitoring.  The
advantages of CMA data over other “surrogate data sets” is that the
chemicals and the job functions of mixer/loader/applicator were defined
based on common application methods used for antimicrobial pesticides.
A few of the deficiencies in the CMA data are noted below:

The inhalation concentrations were typically below the detection limits,
so the unit exposures for the inhalation exposure route could not be
accurately calculated.

QA/QC problems including lack of either/or field fortification,
laboratory recoveries, and storage stability information.

Data have an insufficient amount of replicates.

The Pesticide Handlers Exposure Database (PHED):

The Pesticide Handlers Exposure Database (PHED) has been developed by a
Task Force consisting of representatives from Health Canada, the U.S.
Environmental Protection Agency (EPA), and the American Crop Protection
Association (ACPA).  PHED provides generic pesticide worker (i.e.,
mixer/loader and applicator) exposure estimates.  The dermal and
inhalation exposure estimates generated by PHED are based on actual
field monitoring data, which are reported generically (i.e., chemical
specific names not reported) in PHED.  It has been the Agency’s policy
to use “surrogate” or “generic” exposure data for pesticide
applicators in certain circumstances because it is believed that the
physical parameters (e.g., packaging type) or application technique
(e.g., aerosol can), not the chemical properties of the pesticide,
attribute to exposure levels. [Note: Vapor pressures for the chemicals
in PHED are in the range of E-5 to E-7 mm Hg.]  Chemical specific
properties are accounted for by correcting the exposure data for study
specific field and laboratory recovery values as specified by the PHED
grading criteria.

PHED handler exposure data are generally provided on a normalized basis
for use in exposure assessments.  The most common method for normalizing
exposure is by pounds of active ingredient (ai) handled per replicate
(i.e., exposure in mg per replicate is divided by the amount of ai
handled in that particular replicate).  These unit exposures are
expressed as mg/lb ai handled.  This normalization method presumes that
dermal and inhalation exposures are linear based on the amount of active
ingredient handled.

APPENDIX C:

Calculation of DDAC Unit Exposure Values

Table C-1:  DDAC Dermal and Inhalation Exposure Values for Chemical
Operators, Graders, Millwrights, Clean-up Crews, and Trim Saw Operators
a

Replicate Number	Chemical Operator	Grader	Trim Saw Operator	Millwright
Cleanup Crew

	Dermal	Inhalation	Dermal	Inhalation	Dermal	Inhalation	Dermal	Inhalation
Dermal	Inhalation

	Potential exposure (mg)	Air Concentration ((g/m3) b, c	Potential
exposured (mg)	Potential exposure (mg)	Air Concentration

((g/m3) b, c	Potential exposure d (mg)	Potential exposure (mg)	Air
Concentration ((g/m3) b, c	Potential exposured (mg)	Potential exposure
(mg)	Air Concentra-tion ((g/m3) b, c	Potential exposured (mg)	Potential
exposure (mg)	Air Concentration ((g/m3) b, c	Potential exposured (mg)

1	3.5	10.1	0.0808	3.05	2.90	0.0232	0.78	2.83	0.0227	1.31	2.92	0.0233
68.3	2.99145	0.0239

2	6.11	2.80	0.0224	7.47	2.93	0.0234	1.98	12.3	0.0984	29.08	2.83	0.0226
0.720	2.78840	0.0223

3	6.07	2.79	0.0223	1.09	2.91	0.0233

8.03	15.6	0.1248	166	30.3	0.2424

4	46.37	2.82	0.0226	10.51	3.00	0.0240

	95.2	412	3.2960

5	0.94	2.93	0.0235	0.61	2.82	0.0226

	1.20	2.83585	0.0227

6	22.15	2.83	0.0227	0.98	2.85	0.0228

	0.260	2.80989	0.0225

7	21.45	2.77	0.0222	2.63	2.91	0.0233

	8	0.22	2.73	0.0218	5.23	2.85	0.0228

	9	0.44	2.77	0.0222	0.19	13.20	0.1056

	10	0.33	3.14	0.0251	1.47	2.89	0.0231

	11	0.29	2.88	0.0230	2.38	2.85	0.0228

	12

4.09	2.81	0.0225

	13

1.03	2.94	0.0235

	Arithmetic Mean	9.81	3.51	0.0281	3.13	3.68	0.0295	1.38	7.57	0.061	12.8
7.12	0.057	55.3	75.6	0.60

Minimum	0.22	2.73	0.0218	0.19	2.81	0.0225	0.78	2.83	0.0227	1.31	2.83
0.0226	0.260	2.79	0.0223

Maximum	46.4	10.1	0.081	10.51	13.2	0.106	1.98	12.3	0.098	29.1	15.6	0.125
166	412	3.30

a.	“Measurement and Assessment of Dermal and Inhalation Exposures to
Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut
Lumber (Phase III)” is the proprietary Sapstain Industry Group (SIG)
study that values were obtained from for this table (Bestari et al.,
1999, MRID 455243-04, SIG Task Force #73154 ).

b.	The inhalation LOD was not provided for chemical operators, graders,
trim saw operators, millwrights, or the clean-up crew.  Therefore, the
LOD provided for the diptank operator (5.6 (g) was used for these
positions.  Residues less than the LOD were adjusted to 1/2 LOD.

c.	The inhalation limit of detection was converted to (g/m3 using the
following equation: Air concentration ((g /m3) = 5.6 (g / [average flow
rate (L/min) * sampling duration (480 min) * 1000 L/m3.  Data was
obtained from Bestari et al (1999).

d.	DDAC air concentrations were converted to inhalation exposure using
the following equation: Air concentration ((g /m3) x inhalation rate
(1.0 m3/hr) x Conversion factor (1mg/1000(g) x sample duration (8
hours/day).

Note: Arithmetic Mean values shown in bold typeface by job function are
recommended for use in dermal and inhalation exposure assessments for
non-pressure wood preservative treatments, where appropriate.

Table C-2:  Normalization of DDAC Dermal and Inhalation Exposure Values
for Diptank Operators a

Worker ID	Mill number	Sample Time (min)	DDAC

Conc. in

Diptank

(%)	Gloves	Dermal Body Exposure b (mg)	Hand Exposure b (mg)	Total Dermal
Exposure (mg)	Normalized Total Dermal Unit Exposure c

(mg/ 1 % solution)	Air Conc.d

(mg/m3)	Inhalation Exposure e (mg)	Normalized Inhalation Unit Exposure c

"

$

%

@

A

a

b

n

€

‚

ƒ

„

#

$

M

V

$

@

a

‚

ƒ

„

„

#

$

[

\

š

›

Õ

Ö

V

X

Y

Z

‹

•

—

™

›

œ

Å

Î

Ð

Ò

Ô

Ú

æ

ì

*Ö

  h·d

萑ː葠ː摧ㆸâ

퀁摧汘?

h

h

h

h

 h

 h

 h

h

h

 h

摧程Ï	㜀$␸䠀$摧݊

h

h'

h'

h'

唁ûꐔ:摧̌

 h{

옍#

옍

 h

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

Ø	@

hä

  hH

hä

 hH

hä

 hH

hä

# hH

hä

  hû

hä

  hH

hä

# hä

hä

hä

hä

hä

gdä

gdä

hH

hH

hä

hä

  hH

hä

 hH

hä

摧繫s

摧噿Ó

摧灥

摧掩Ý

@

h

h

옍)

@

@

@

@

@

␃؁Ĥ옍)

␃؁Ĥ옍)

옍)

萏Ό萑ﻮ葞Ό葠ﻮ摧㎩È$؀Ĥ옍)

愀Ĥ摧掩Ý$̀Ĥ옍)

$̀Ĥ옍)

$̀Ĥ옍)

옍)

옍)

؀Ĥ옍)

옍)

옍)

)

옍

옍#

@

@

옍)

Æ#

옍)

؀Ĥ옍#

摧㘼vᬀ 옍#

@

@

␃؁Ĥ옍)

'̀Ĥ␅؁Ĥ옍)

š

'̀Ĥ␅؁Ĥ옍)

š

@

옍)

옍)

@

@

@

@

@

@

@

옍)

 h{

옍)

ú

ü

 h{

  h{

 h{

@

@

Æ

@

.

4

5

<

=

C

D

¸

½

@

@

@

@

 h{

  h{

 h{

 h{

 h{

 h{

 h{

옍

옍

옍

 h{

 h{

@

@

@

@

@

@

@

@

&

  h{

&

  h{

␅؁Ĥ옍)

踆

踆

踆

@

摧掩Ý-਀&䘋

Ž

摧掩Ý─ ␃਀&䘋

Ž

摧掩Ý─ ␃਀&䘋

Ž

h

옍#

$

  hå

옍#

  h M

h

CJ

aJ

  hå

h

h

h

  h M

옍#

옍#

옍#

h

  hå

h

옍)

옍)

@

 hcy

  hcy

 hcy

  hcy

 hcy

咊ጣ̀Ĥ옍#

옍)

 h^

 h^

  h^

ᜀ 옍#

옍

옍

摧畝Bᬀ 옍#

옍#

摧畝Bἀ ␃਀&䘋 옍#

옍#

÷óîóçóàÙàóÔÐÉÐÉÐÉÐÉÐÔÐÂÐÂÐÂÐÂ¾ÂÐÂÐÂÐ
ÂÐ·Ð·¾ÐÂÐÂÐÔ¯Ô¯Ô¯Ô¯Ô¯©¢©¢©¢©

ጣ̀Ĥ옍#

摧᳷jἀ ␃਀&䘋 옍#

옍)

옍

@

摧ό´ᬀ 옍#

$̀Ĥ옍)

Æ

옍)

옍)

옍)

옍

옍)

Ff-

摧߻)ጝ؀Ĥ옍#

hò&

„

ž

옍

옍

옍)

愀Ĥ摧掩Ýഀ„

†

§

hò&

ἀ ␃਀&䘋 옍#

∀ ␃਀&䘋 옍)

ᬀ 옍#

hò&

ἀ ␃਀&䘋 옍#

␱愁$摧珒¿ᬀ 옍#

 hT]

 hT]

 hO

hò&

ᬀ 옍#

í

hò&

{

hò&

摧噿Ó

hò&

hò&

$

„@

摧噿Ó

摧噿Ó

摧噿Ó

옍

옍

hò&

Æ

Æ

Æ

Æ

Æ

옍

옍

 hO

=

hí

hí

hí

hí

hí

hí

hí

hí

hí

摧危^

옍)

옍)

옍)

옍)

h¼j

摧檼

h¦

h¼j

怆



`

ð

`

ð

 hÊE

`

ð

`

ð

`

ð

혈F鐃᳿ꐋⰖ"蠆

蠆

蠆

 hÊE

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

혈F鐃᳿ꐋⰖ"蠆

蠆

ˆ

 hÊE

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

혈F鐃᳿ꐋⰖ"蠆

蠆

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

ˆ

̀Ĥ옍)

Ò

Ó

옍)

옍)

 h

 h

 h

옍)

̀Ĥ옍)

옍)

  h¶

Ff×

.045

90%tile	0.39	3.37	3.66	5.78	0.0030	0.0240	0.057

Maximum	0.50	3.44	3.94	6.16	0.0030	0.0240	0.057

a.	“Measurement and Assessment of Dermal and Inhalation Exposures to
Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut
Lumber (Phase III)” is the proprietary Sapstain Industry Group (SIG)
study that values were obtained from for this table (Bestari et al.,
1999, MRID 455243-04, SIG Task Force #73154).

b.	DDAC concentration that was detected in the monitoring study (MRID
#455243-04).

c.	Normalization of DDAC data for percent ai treatment.  Normalized Unit
Exposure (mg/1% ai solution) = Exposure (mg DDAC) / concentration in
diptank solution (% DDAC)

d.	All inhalation residues were <LOD (5.6 (g or 0.0056 mg/m3). 1/2 LOD
was used in all calculations (0.003 mg/m3). Air Concentration (mg/m3) =
5.6 (g / (~2 L/min flow rate x ~480 min) x 1000 L/m3 conversion x 0.001
(g /mg = 0.003 mg/m3

e.	Inhalation exposure (mg) = air concentration (mg/m3) x inhalation
rate (1.0 m3/hr) x sample duration (8 hours/day).

f.	Residues were <LOD for dermal samples M8P4A, M8P4B.  Sample size of
~11,231 cm2 x <0.007 ug/cm2 = LOD of 0.079 mg.  1/2 LOD reported (i.e.,
0.04 mg)

Note: Arithmetic Mean values shown in bold typeface are the recommended
Normalized Dermal and Inhalation Unit Exposure values for use in
exposure assessments for non-pressure wood

 Because the ST dermal toxicological endpoint is based on skin
irritation and provided in terms of body surface area, the exposure must
be calculated in terms of body surface area (i.e., mg a.i. per cm2

4 To convert from volume to weight of ready-to-use product, the density
of the product is required.  Product density was provided on some, but
not all, labels.  A density of 8.5 lb/gal was assumed for all products
based on the typical label values that were present. Where dilution of
product was included in the use instructions, it was assumed that the
product was diluted with water at a density of 8.34 lb/gal (although it
is noted that some product labels instruct the user to dilute with an
organic solvent such as mineral spirits for some uses).

 The following discussion concerns copper naphthenate.  However, the
Agency assumes that environmental exposures and risks of zinc
naphthenate are similar to those of copper naphthenate.

 PAGE  13

  PAGE  1

 PAGE  46

  PAGE  14

 PAGE  70

 PAGE

 PAGE   79


[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Rules and Regulations]
[Page 66131]
[FR Doc No: 2018-27831]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-1054]

Drawbridge Operation Regulation; Duwamish Waterway, Seattle, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Southwest Spokane Street Bridge
(Spokane Street Bridge), mile 0.3, across the Duwamish Waterway at
Seattle, WA. The deviation is necessary to accommodate re-routed
roadway traffic while the Alaskan Way Viaduct is closed. This deviation
allows the subject bridge to remain in the closed-to-navigation
position to allow congested roadway traffic to move easier.

DATES: This deviation is effective from 7 a.m. on January 11, 2019, to
7 p.m. on February 9, 2019.

ADDRESSES: The docket for this deviation, USCG-2018-1054 is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Seattle Department of Transportation (SDOT),
the owner of the impacted drawbridges, requested a temporary deviation
from the operating schedule for the Spokane Street Bridge, mile 0.3,
across the Duwamish Waterway at Seattle, WA, to facilitate morning and
afternoon re-routed roadway traffic. Washington Department of
Transportation is closing the Alaskan Way Viaduct forever, and have not
finished building new ramp approaches to the new SR99 Tunnel into
Seattle, WA. During the closure of the viaduct, SDOT will be re-routing
roadway traffic into Seattle across the Duwamish Waterway, and
requested to not open the subject bridge to marine vessels during
morning and afternoon hours. The normal operating schedule for the
Spokane Street Bridge is in 33 CFR 117.5; which is open on signal. The
Spokane Street Bridge provides a vertical clearance of 55 feet for the
center 130 feet in the closed-to-navigation position, and 44 feet in
the closed-to-navigation position on both sides. Vertical clearances
refer to the Mean High tide level.
    During this deviation period, the Spokane Street Bridge draw need
not open to vessels from 7 a.m. to 10 a.m., and from 2 p.m. to 5 p.m.
from January 11, 2019 to February 9, 2019, for vessels less than 5000
gross tons. If a vessel has in tow a vessel of 5000, or more, gross
tons, or is a vessel proceeding to pick up a tow vessel of 5000, or
more, gross tons, the Spokane Street Bridge shall open on signal. Delta
Marine will be conducting sea trials during this deviation period with
a 174 foot, 900 ton vessel; SDOT has agreed to open the subject bridge,
on signal, for the Delta Marine vessel during this deviation period.
Waterway usage on the Duwamish Waterway range from large mega yachts,
commercial tug and barge to small pleasure craft. Vessels able to pass
through the subject bridge in the closed-to-navigation position may do
so at any time. The Spokane Street Bridge will not be able to open for
emergencies, and there is no immediate alternate route for vessels to
pass. The Coast Guard will also inform the users of the waterways
through our Local and Broadcast Notices to Mariners of the change in
operating schedule for the bridges so that vessel operators can arrange
their transits to minimize any impact caused by the temporary
deviation.
    In accordance with 33 CFR 117.35(e), the Spokane Street Bridge must
return to its regular operating schedule immediately at the end of the
effective period of this temporary deviation. This deviation from the
operating regulations is authorized under 33 CFR 117.35.

    Dated: December 3, 2018.
Steven M. Fischer,
Bridge Chief Administrator, Thirteenth Coast Guard District.
[FR Doc. 2018-27831 Filed 12-21-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Notices]
[Page 59523]
[FR Doc No: 2020-20914]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14308-011]

Carbon Zero, LLC; North Bennington Hydroelectric LLC; Notice of
Application for Transfer of License and Soliciting Comments, Motions To
Intervene, and Protests

    On August 31, 2020, Carbon Zero, LLC (transferor) and North
Bennington Hydroelectric LLC (transferee) filed jointly an application
for the transfer of license of the Vermont Tissue Mill Dam
Hydroelectric Project No. 14308. The project is located on the
Walloomsac River, Bennington County, Vermont.
    The applicants seek Commission approval to transfer the license for
the Vermont Tissue Mill Dam Hydroelectric Project from the transferor
to the transferee.
    Applicants Contact: For transferor: Maria Scully, Carbon Zero, LLC,
P.O. Box 338, North Bennington, VT 05257, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    For transferee: Arion Thiboumery, North Bennington Hydroelectric
LLC, 4304 East Hill Rd., Plainfield, VT 05667, Phone:<PHONE_NUMBER>,
exception occurred on : 2020-20914.htm
exception occurred on : 2020-20914.htm
Email: ion.net">[email protected]ion.net.
    FERC Contact: Anumzziatta Purchiaroni,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, and protests:
30 days from the date that the Commission issues this notice. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY).
    In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Submissions sent via any other carrier must be
addressed to Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. The first
page of any filing should include docket number P-14308-011. Comments
emailed to Commission staff are not considered part of the Commission
record.

    Dated: September 16, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-20914 Filed 9-21-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Page 3707]
[FR Doc No: 2018-01391]

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

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9037-3]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www2.epa.gov/nepa/ nepa/.

Weekly receipt of Environmental Impact Statements
Filed 01/15/2018 Through 01/19/2018
Pursuant to 40 CFR 1506.9

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-nepa-public/action/eis/search.

EIS No. 20180006, Draft, BLM, WY, Converse County Oil and Gas Project
Draft EIS, Comment Period Ends: 03/12/2018, Contact: Mike Robinson
(307) 261-7520
EIS No. 20180007, Draft, USFS, CO, Berlaimont Estates Road Improvement
Project, Comment Period Ends: 03/12/2018, Contact: Matthew Klein 941-
400-4452
EIS No. 20180008, Final, BLM, CA, Abbreviated Final Environmental
Impact Statement Proposed Land Exchange between Bureau of Land
Management and Agua Caliente Band of Cahuilla Indians, Review Period
Ends: 03/12/2018, Contact: Ashley Adams<PHONE_NUMBER>

    Dated: January 22, 2018.
Kelly Knight,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2018-01391 Filed 1-25-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Page 37063]
[FR Doc No: 2023-12076]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 7189-015]

Green Lake Water Power Company; Notice of Intent To Prepare an
Environmental Assessment

    On March 31, 2022, Green Lake Water Power Company filed a relicense
application for the 500-kilowatt Green Lake Hydroelectric Project No.
7189 (project). The project is located on Green Lake and Reeds Brook in
Hancock County, Maine.
    In accordance with the Commission's regulations, on March 23, 2023,
Commission staff issued a notice that the project was ready for
environmental analysis (REA Notice). Based on the information in the
record, including comments filed on the REA Notice, staff does not
anticipate that licensing the project would constitute a major federal
action significantly affecting the quality of the human environment.
Therefore, staff intends to prepare an Environmental Assessment (EA) on
the application to relicense the project.
    The EA will be issued and circulated for review by all interested
parties. All comments filed on the EA will be analyzed by staff and
considered in the Commission's final licensing decision.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].
    The application will be processed according to the following
schedule. Revisions to the schedule may be made as appropriate.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Commission issues EA......................  November 2023.\1\
Comments on EA............................  December 2023.
------------------------------------------------------------------------

    Any questions regarding this notice may be directed to Amanda Gill
at<PHONE_NUMBER> or [email protected].
---------------------------------------------------------------------------

    \1\ The Council on Environmental Quality's (CEQ) regulations
under 40 CFR 1501.10(b)(1) require that EAs be completed within 1
year of the federal action agency's decision to prepare an EA. This
notice establishes the Commission's intent to prepare an EA for the
Green Lake Hydroelectric Project. Therefore, in accordance with
CEQ's regulations, the EA must be issued within 1 year of the
issuance date of this notice.

    Dated: May 31, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-12076 Filed 6-5-23; 8:45 am]
BILLING CODE 6717-01-P