[Federal Register: July 28, 2008 (Volume 73, Number 145)]
[Notices]
[Page 43820-43821]
[DOCID:fr28jy08-135]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Notice of Date for Submission of Requests for Confidential
Treatment of Certain Early Warning Reporting Data

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

ACTION: Notice.

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SUMMARY: This notice establishes a submission date for those
manufacturers that choose to submit requests for confidential treatment
of Early Warning Reporting data on incidents involving a death or an
injury, property damage claims or light vehicle production to send the
requests to NHTSA's Chief Counsel.

DATES: Requests for confidential treatment of previously submitted
Early Warning Reporting data on incidents involving a death or an
injury, on property damage claims and on light vehicle production must
be submitted to NHTSA's Chief Counsel by August 27, 2008.

FOR FURTHER INFORMATION CONTACT: Mr. Andrew J. DiMarsico, NHTSA Office
of the Chief Counsel, W41-227, 1200 New Jersey Avenue, SE., Washington,
DC 20590 (Telephone:<PHONE_NUMBER>) (Fax:<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION: The Transportation Recall Enhancement,
Accountability, and Documentation (TREAD) Act, which was enacted in
2000, required NHTSA to prescribe rules establishing early warning
reporting (EWR) requirements. 49 U.S.C. 30166(m). On July 10, 2002,
NHTSA published regulations implementing the early warning reporting
provisions. 49 CFR part 579 Subpart C, 67 FR 45822. In general, the EWR
regulations require manufacturers of motor vehicles (producing 500 or
more vehicles annually), all manufacturers of child restraint systems
and manufacturers of tires above a specified volume to report, on a
quarterly basis, information on production, incidents involving
fatalities and injuries based on claims and notices, claims for
property damage, consumer complaints, warranty claims and field
reports, and to submit copies of certain field reports. See 49 CFR
579.21-26. Manufacturers of motor vehicles that produce less than 500
vehicles annually, and all other equipment manufacturers, do not
provide quarterly reports, but are required to report information on
incidents involving death(s) based on claims or notices. See 49 CFR
579.27. Additionally, manufacturers were required to file initial
reports containing historical data. See 49 CFR 579.28(c). The EWR rule
did not address whether the information submitted by manufacturers
would be released to the public.
    On July 28, 2003, NHTSA published an appendix to its Confidential
Business Information (CBI) rule that addressed the confidentiality of
EWR data. See 49 CFR part 512 App. C, 68 FR 44209. The rule established
class determinations that EWR information on production numbers (except
for light vehicles), consumer complaints, warranty claims and field
reports (including copies of reports) were confidential. NHTSA
subsequently amended the rule to add a class determination that common
green tire data are confidential. 69 FR 21409 (April 21, 2004). During
the rulemaking, NHTSA declined to adopt a request by commenters that
EWR data on deaths and injuries and on property damage claims
(collectively, ``EWR claims data'') be accorded confidentiality.
Instead, manufacturers could submit individualized requests for
confidential treatment of their EWR claims data. If a manufacturer did
not submit a request for confidential treatment of its EWR claims data,
the agency would be free to disclose it.
    Litigation over the provisions in NHTSA's rule on the
confidentiality of EWR data was instituted in March of 2004. Public
Citizen challenged the class determinations and sought to have them set
aside. The Rubber Manufacturers Association (RMA), a trade association
that includes tire manufacturers, intervened contending that all EWR
information including EWR claims data is exempt from disclosure. This
was based on the legal theory that the TREAD Act precluded the
disclosure of the data and thus under Exemption 3 of the Freedom of
Information Act, 5 U.S.C. 552(b)(3),\1\ NHTSA could not release EWR
data. In addition, some RMA members submitted requests for
confidentiality of EWR claims data, which NHTSA denied. RMA's complaint
as an intervenor challenged those denials as well as the rule.
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    \1\ Exemption 3 incorporates the various nondisclosure
provisions contained in other Federal statutes. It provides for the
withholding of information specifically exempted from disclosure by
statute, provided that such statute ``(A) requires that the matters
be withheld from the public in such a manner as to leave no
discretion on the issue, or (B) establishes particular criteria for
withholding or refers to particular types of matters to be
withheld.'' 5 U.S.C. 552(b)(3).
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    In light of the RMA claim in the lawsuit, NHTSA stayed the
processing of requests for confidential treatment of EWR information
until the matters in litigation were resolved. The agency further
advised manufacturers that until further notice they should not request
confidential treatment of EWR information.
    In its resolution of the litigation, the District Court issued two
opinions. In the first, the Court found that NHTSA had the authority to
make the class determinations of confidentiality but had failed to
follow proper notice and comment procedures when it did so. It remanded
the matter back to NHTSA. See Public Citizen, Inc. v. Mineta, 427
F.Supp.2d 7 (D.D.C. 2006). In a subsequent decision, the Court rejected
RMA's contention that the TREAD Act precluded NHTSA from releasing EWR
data. See Public Citizen, Inc. v. Mineta, 444 F.Supp.2d 12 (D.D.C.
2006). RMA appealed. On July 22, 2008, the U.S. Court of Appeals for
the District of Columbia Circuit affirmed the judgment of the District
Court on RMA's claim that the TREAD Act precluded the release of all
EWR data. Public Citizen, Inc., v. Rubber Manufacturers Association,
No. 06-5304, -- F.3d -- (DC Cir. 2008).
    While RMA's appeal was pending, in response to the District Court's
remand of the 2003 rule, NHTSA published a rule on the confidentiality
of EWR data. See 72 FR 59434 (Oct. 19, 2007). The 2007 rule contained
class determinations that EWR information on production numbers (except
for light vehicles), consumer complaints, warranty claims, field
reports (including copies of field reports) and common green tire data
are confidential. Significantly, under the 2007 rule, EWR claims data
is not covered by any class determinations. Accordingly, manufacturers
seeking confidential treatment for EWR claims data may do so by
submitting individual requests for

confidential treatment pursuant to 49 CFR part 512.
    This notice addresses the timing of submission of requests for
confidentiality of EWR claims data and production data for light
vehicles. The agency's EWR CBI rule did not resolve the confidentiality
of those data. Instead, as noted above, this was left to individual
requests for confidentiality, if manufacturers chose to submit them.
And, if a manufacturer did not submit a request covering EWR claims
data or, for light vehicles, production data, NHTSA was free to release
those data submitted by the manufacturer. However, NHTSA issued an
administrative stay of the release of the EWR claims data pending the
resolution of the litigation and advised manufacturers not to submit
requests for confidentiality while the stay was in effect. In view of
the decision and judgment by the Court of Appeals, the stay is no
longer operative.
    NHTSA is providing manufacturers a limited opportunity to request
confidentiality for previously submitted EWR claims data (information
on incidents involving death or injury or property damage claims) and,
for light vehicles, production data. There are two general groups of
EWR data at issue. The first is EWR claims data and light vehicle
production data previously submitted to the agency pursuant to the EWR
rule. NHTSA's naming convention rules for the submission of electronic
EWR quarterly reports require manufacturers to denominate their EWR
submissions with a ``C'' in the Confidentiality Request Identifier to
indicate that the manufacturer contends that the EWR claims data and/or
light vehicle production data is confidential. However, the ``C'' in
the file naming convention alone does not confer confidential treatment
for EWR claims data and light vehicle production data. Manufacturers
seeking confidential treatment for this information must submit a
request pursuant to 49 CFR part 512 to the Chief Counsel of NHTSA by
mail, express courier (e.g., Fed Ex, UPS, DHL), or hand delivery, which
is due by August 27, 2008. A request for confidential treatment may be
made even if an EWR report was submitted without the ``C'' designation.
If a request for confidential treatment is not submitted by the above
date, the agency will be free to disclose the data regardless if a
``C'' is included in the file name of the EWR report.
    The second group of EWR data at issue is EWR claims data and light
vehicle production data submitted in the future. Consistent with 49 CFR
part 512, manufacturers choosing to request confidential treatment for
such data are required to submit individual requests for confidential
treatment to NHTSA's Chief Counsel in connection with their electronic
submissions of EWR quarterly reports. While quarterly EWR reports are
submitted electronically and require a ``C'' in the file naming
convention to indicate a request for confidential treatment, an
individualized request under 49 CFR part 512 must also be sent by mail,
express courier or hand delivery to the Chief Counsel of NHTSA.

     Issued on: July 23, 2008.
Lloyd S. Guerci,
Assistant Chief Counsel for Litigation and Enforcement.
 [FR Doc. E8-17237 Filed 7-25-08; 8:45 am]

BILLING CODE 4910-59-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

MEMORANDUM								July 17, 2007

SUBJECT:		Ecological Hazard and Environmental Risk Assessment Chapter
for Naphthenate Salts Reregistration Eligibility Decision (RED) Document
(Case No.: 3099)

FROM:		Genevieve Angle, Biologist

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

TO:			Mark Hartman, Branch Chief

Diane Isbell, Team Leader

Kathryn Avivah Jakob, Chemical Review Manager

Timothy McMahon, Risk Assessor

Regulatory Management Branch II

Antimicrobials Division (7510P)

THRU:		Nader Elkassabany, Team Leader, Team Two

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Norman Cook, Branch Chief

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Chemical Names				PC Codes

Copper Naphtheante/ Zinc Naphthenate	023102, 088301

Attached is the Ecological Hazard and Environmental Risk Assessment
chapter for the naphthenate salts RED Document.

ECOLOGICAL HAZARD AND ENVIRONMENTAL

RISK ASSESSMENT CHAPTER

Naphthenate Salts

PC Codes 023102, 088301

CASE No.: 3099

05/14/07

Genevieve Angle, Biologist

Antimicrobials Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW

Washington, DC 20460

Table of Contents

												    Page

Executive Summary
………………………………………………………………
……………… 1

1.  Ecological Toxicity Data . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

A.  Toxicity to Terrestrial Animals . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .3

1.  Birds, Acute  . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . 3

2.  Birds, Subacute. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . 4

3.  Mammals, Acute and Chronic . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . .5

B.  Toxicity to Aquatic Animals . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .5

1.  Freshwater Fish, Acute . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . .6

2.  Freshwater Invertebrates, Acute . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . .6

3.  Estuarine and Marine Organisms, Acute . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . .7

4.  Aquatic Organisms, Chronic . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . .7

C.  Toxicity to Plants . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . ..7

II.  Risk Assessment and Risk Characterization . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . ..8

A.  Environmental Fate Assessment Summary . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . .. . . . ..8

B.  Environmental Exposure And Ecological Risk Assessment. . . . . . . .
. . . . . . . . .. . ... . . . .9

C.  Endangered Species Considerations . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . .  . . . . . . . . . ..13

III.  Confirmatory Data Required . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . ... 14

IV.  Label Hazard Statements for Terrestrial and Aquatic Organisms . . .
. . . . . . ..  . . . . . . . . . .15

V.  References . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . .  . . . . . . . . . . 16

LIST OF TABLES

																			  Page

Table 1 – Acute Oral Toxicity of Naphthenate Salts to Birds. . . . . .
. . . . . . . . . . . . . . . . . . . . .3

Table 2 – Subacute Oral Toxicity of Naphthenate Salts to Birds. . . .
. . . . . . . . . . . . . . . . . . . . 4

Table 3 – Acute Toxicity of Naphthenate Salts to Freshwater Fish. . .
. . . . . . . . . . . . . . . . . . . 5

Table 4 – Acute Toxicity of Naphthenate Salts to Freshwater
Invertebrates. . . . . . . . . . . . . . . 5

	Ecological Hazard and Environment Risk Assessment

For Naphthenate Salts

Executive Summary:

		Naphthenate salts (copper naphthenate and zinc naphthenate) are
currently registered as fungicides, insecticides and miticides for
materials preservation and wood preservation.  Materials preservative
uses include:  fabrics and textiles, rope, burlap, canvas, cellulosic
materials, boat coverings and sails, nets, seines, tents, awnings,
particle board and insulation board.  Wood preservative uses include:
lumber, timber, logs, plywood, posts, poles, fences, pilings, flooring,
shingles, siding, sills, steps, doors, flower boxes, decks/porches,
roofs, ladders, outdoor furniture, landscaping material, millwork,
docks, piers, boat hulls and boats.

	The wood treatment uses of naphthenate salts have high potential for
environmental exposure and thus require an environmental risk
assessment.  Use of treated nets and seines also may provide for
environmental exposures, but copper naphthenate wood treatment uses are
expected to provide for greater environmental exposure and are assessed
here.  All other uses are considered indoor and have minimal to no
environmental exposure potential following use.

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 I 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.

Data Gaps:

	Confirmatory Data Required For Wood Treatment Risk Assessment:

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),

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).

Label Hazard Statements/Use Recommendations:

Naphthenate salts labels must state:

“This pesticide is toxic to aquatic invertebrates, shrimp, and
oysters/clams.”

"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authorities are notified in writing
prior to discharge.  Do not discharge effluent containing this product
to sewer systems without previously notifying the local sewage treatment
plant authority.  For guidance contact your State Water Board or
Regional Office of the EPA."

Wood preservative labels must state:  "Treated lumber must be stored
under cover, indoors, or at least 100 feet from any pond, lake, stream,
wetland, or river to prevent possible runoff of the product into the
waterway.  Treated lumber stored within 100 feet of a pond, lake,
stream, wetland, or river must be either covered with plastic or
surrounded by a berm to prevent surface water runoff into the nearby
waterway.  If a berm or curb is used around the site, it should consist
of impermeable material (clay, asphalt, concrete) and be of sufficient
height to prevent runoff during heavy rainfall events.”

The honeybee 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.

I.	Ecological Toxicity Data

	The toxicity endpoints presented below are based on the results of
ecotoxicity studies submitted to EPA to meet the Agency’s data
requirements for the uses of naphthenate salts.

	A.	Toxicity to Terrestrial Animals

(1)	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 1).

Table 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	423486-01

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	423486-04

	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.

(2)	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 2).

Table 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	423486-05

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	423486-06

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	423486-02

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	423486-03

	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).

 (3)	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.

B.	Toxicity to Aquatic Animals

	The Agency requested that aquatic toxicity studies be conducted with
naphthenate salts since, under typical use conditions, it is introduced
into the aquatic environment.

(1)	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 3.

 Table 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	424891-01

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	424891-02

	Freshwater acute toxicity tests indicate that naphthenate salts are
moderately toxic to fish on an acute basis.  Study 424891-02 fulfills
the guideline requirement for the coldwater species and study 424891-01
fulfills the guideline requirement for the warmwater fish species under
OPPTS 850.1075 (72-1a&b).

	(2)	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 4).

	Table 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 	424891-03

	The results of 424891-03 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.”

(3)	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)).

 (4)	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).

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).

II.	Risk Assessment and Characterization

	Naphthenate salts uses are classified as “indoor” with the
exception of the wood treatment uses.  An ecological risk assessment is
not typically conducted for “indoor” uses.  A risk assessment for
the wood preservative uses is conducted below using the toxicity values
from section I and estimated environmental concentrations (EECs)
calculated by modeling copper naphthenate leaching into a body of water
from a dock.  These values were used to develop risk quotients (RQs) and
compare them to levels of concern (LOCs) in section B below.  Modeling
was not conducted for zinc naphthenate, but environmental exposures are
assumed to be similar to those for copper naphthenate.

      A.        Environmental Fate Assessment Summary

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 low 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 low 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.

B.	Environmental Exposure and Ecological Risk Assessment

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 424891-01).  The
EC50 value obtained in a study on the freshwater invertebrate (Daphnia
magna) was 0.34 mg/L (MRID 424891-03).  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.

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.

      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.

Confirmatory Data Required To Support Wood Treatment Use:

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).

IV.	 Label Hazard Statements for Terrestrial and Aquatic Organisms and
Use                              Recommendations

Naphthenate salts labels must state:

“This pesticide is toxic to aquatic invertebrates, shrimp, and
oysters/clams.”  (Note:  Estuarine organisms are added based on
freshwater toxicity.  Shrimp, oysters and clams should stay in the label
hazard statement until such time as data proves otherwise.)

"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authorities are notified in writing
prior to discharge.  Do not discharge effluent containing this product
to sewer systems without previously notifying the local sewage treatment
plant authority.  For guidance contact your State Water Board or
Regional Office of the EPA."

Wood preservative labels must state:

"Treated lumber must be stored under cover, indoors, or at least 100
feet from any pond, lake, stream, wetland, or river to prevent possible
runoff of the product into the waterway.  Treated lumber stored within
100 feet of a pond, lake, stream, wetland, or river must be either
covered with plastic or surrounded by a berm to prevent surface water
runoff into the nearby waterway.  If a berm or curb is used around the
site, it should consist of impermeable material (clay, asphalt,
concrete) and be of sufficient height to prevent runoff during heavy
rainfall events.”

“Wood treated with copper/zinc naphthenate shall not be used in the
construction of beehives.”  (Note:  If this statement is not added to
wood preservation labels, bee studies are required as noted above.)

V.  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

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

  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

 PAGE   i


[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62141-62142]
[FR Doc No: 2016-21552]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2513]

ICH S3A Guidance: Note for Guidance on Toxicokinetics: The
Assessment of Systemic Exposure in Toxicity Studies--Questions and
Answers; International Council for Harmonisation; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance entitled ``ICH S3A Guidance: Note
for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in
Toxicity Studies--Questions and Answers.'' The draft guidance was
prepared under the auspices of the International Council for
Harmonisation (ICH), formerly the International Conference on
Harmonisation. This question and answer (Q&A) guidance provides
additional information to facilitate interpretation of the ``S3A
Guidance: The Assessment of Systemic Exposure in Toxicity Studies''
(S3A guidance), especially to address the benefit and use of
microsampling techniques in main study animals. The Q&A guidance is
intended to provide points to consider before incorporating the
microsampling method in toxicokinetic studies, and acknowledges the
benefits (and some limitations) of the use of microsampling.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 7, 2016.

ADDRESSES: You may submit comments as follows:

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    Submit electronic comments in the following way:
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Follow the instructions for submitting comments. Comments submitted
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docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research
(CDER), Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Aisar Atrakchi, Center for Drug Evaluation
and Research, Food and Drug Administration, Bldg. 22, Rm. 4118, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Anne Pilaro, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 4025, Silver Spring, MD 20993-0002,
240-402-8341.
    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 1128, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory Agencies.
    ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; the Japanese Ministry of
Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
    The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers. In
May 2016, the ICH Assembly endorsed the draft guidance entitled ``ICH
S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of
Systemic Exposure in Toxicity Studies--Questions and Answers'' and
agreed that the guidance should be made available for public comment.
The draft guidance is the product of the Safety Expert Working Group of
the ICH. Comments about this draft will be considered by FDA and the
Safety Expert Working Group.
    The draft Q&A guidance provides additional information to
facilitate interpretation of the S3A guidance. The S3A guidance has
been successfully implemented since 1994, and in recent years,
analytical method sensitivity has improved, allowing microsampling
techniques to be used in toxicokinetic assessment. This Q&A guidance
focuses on points to consider before incorporating the microsampling
method in toxicokinetic studies, acknowledges the benefits (and some
limitations) of the use of microsampling for assessing toxicokinetics
in main study animals, and acknowledges the overall important
contribution of microsampling to the 3Rs benefits (Replacement,
Reduction, and Refinement), by reducing or eliminating the need for
toxicokinetic satellite animals.
    The draft Q&A guidance is intended to apply to the majority of
pharmaceuticals and biopharmaceuticals; however, for all types of
molecules, consideration should be given on a case-by-case basis as to
whether the sensitivity of the measurement method is appropriate with
the small sample volumes available.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ICH ``S3A
Guidance: Note for Guidance on Toxicokinetics: The Assessment of
Systemic Exposure in Toxicity Studies--Questions and Answers.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Electronic Access

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

    Dated: September 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21552 Filed 9-7-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Rules and Regulations]
[Pages 10215-10216]
[FR Doc No: 2011-3534]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0951; Directorate Identifier 2010-NM-107-AD;
Amendment 39-16608; AD 2011-04-08]
RIN 2120-AA64

Airworthiness Directives; Learjet Inc. Model 45 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD requires a general visual inspection for
damage of wiring (including chafing, pinched wires, and exposed wires)
and correct routing of wires in the left and right circuit breaker
panels, and related investigative and corrective actions if necessary.
This AD results from reports of wire damage on the pilot and copilot
circuit breaker panels caused by a short circuit between chafed wiring
and the circuit breaker panel forward mounting bracket. We are issuing
this AD to detect and correct damaged or misrouted wires, which could
result in a short circuit and the loss of systems associated with the
wiring (including fire suppression function for one engine and
essential avionics systems).

DATES: This AD is effective March 31, 2011.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of March 31,
2011.

ADDRESSES: For service information identified in this AD, contact
Learjet, Inc., One Learjet Way, Wichita, Kansas 67209-2942; telephone
316-946-2000; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet http://www.bombardier.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jose Flores, Aerospace Engineer,
Electrical Systems and Avionics, ACE-119W, FAA, Wichita Aircraft
Certification Office (ACO), 1801 Airport Road, Room 100, Mid-Continent
Airport, Wichita, Kansas 67209; telephone<PHONE_NUMBER>; fax 316-946-
4107.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
the specified products. That NPRM was published in the Federal Register
on October 1, 2010 (75 FR 60667). That NPRM proposed to require a
general visual inspection for damage of wiring (including chafing,
pinched wires, and exposed wires) and correct routing of wires in the
left and right circuit breaker panels, and related investigative and
corrective actions if necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
and the FAA's response to each comment.

Request To Revise Unsafe Condition

    Learjet requested that we revise the unsafe condition, as stated in
paragraph (e) of the NPRM, to ``This AD results from reports of wire
damage on the pilot and copilot circuit breaker panels caused by a
short circuit between chafed wiring and the circuit breaker panel
forward mounting bracket'' instead of ``This AD results from reports of
wire damage on the pilot and copilot circuit breaker panels caused by a
short circuit between chafed wires.''
    We agree with the commenter's request. We have revised the language
in the SUMMARY section and paragraph (e) of this AD accordingly.

Request To Revise Paragraph (g) of the NPRM

    Learjet requested that we revise paragraph (g) of the NPRM to
``except if arcing damage is found on the forward mounting bracket of
the circuit breaker panel'' instead of ``except if arcing damage is
found on the mounting brackets of the forward circuit breaker panel.''
    We agree with the request provided by the commenter. We have
revised paragraph (g) of this AD accordingly.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 339 airplanes of U.S. registry. We
also estimate that it would take about 1 work-hour per product to
comply with this AD. The average labor rate is $85 per work-hour. Based
on these figures, we estimate the cost of this AD to the U.S. operators
to be $28,815, or $85 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
subtitle VII, part A, subpart III, section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),

    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2011-04-08 Learjet Inc.: Amendment 39-16608; Docket No. FAA-2010-
0951; Directorate Identifier 2010-NM-107-AD.

Effective Date

    (a) This AD is effective March 31, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Learjet Inc. Model 45 airplanes,
certificated in any category; having serial numbers identified in
paragraphs (c)(1) and (c)(2) of this AD.
    (1) Serial numbers 45-2001 through 45-2114 inclusive, 45-2116
through 45-2120 inclusive, 45-2122, 45-2125, and 45-2126.
    (2) Serial numbers 45-005 through 45-380 inclusive, 45-382
through 45-391 inclusive, 45-393 through 45-396 inclusive, 45-398,
45-400, 45-401, and 45-403.

Subject

    (d) Air Transport Association (ATA) of America Code 24:
Electrical power.

Unsafe Condition

    (e) This AD results from reports of wire damage on the pilot and
copilot circuit breaker panels caused by a short circuit between
chafed wiring and the circuit breaker panel forward mounting
bracket. The Federal Aviation Administration is issuing this AD to
detect and correct damaged or misrouted wires, which could result in
a short circuit and the loss of systems associated with the wiring
(including fire suppression function for one engine and essential
avionics systems).

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Inspection and Corrective Action

    (g) Within 50 flight hours after the effective date of this AD:
Do a general visual inspection for damage of wiring and correct
routing of wires in the left and right circuit breaker panels, and
all applicable related investigative and corrective actions, in
accordance with the Accomplishment Instructions of Bombardier Alert
Service Bulletin A40-24-11, dated November 16, 2009; or Bombardier
Alert Service Bulletin A45-24-16, dated November 16, 2009; as
applicable; except if arcing damage is found on the forward mounting
bracket of the circuit breaker panel, before further flight, repair
in accordance with a method approved by the Manager, Wichita
Aircraft Certification Office, FAA. Do all applicable related
investigative and corrective actions before further flight.

    Note 1: For the purposes of this AD, a general visual inspection
is: ``A visual examination of an interior or exterior area,
installation, or assembly to detect obvious damage, failure, or
irregularity. This level of inspection is made from within touching
distance unless otherwise specified. A mirror may be necessary to
ensure visual access to all surfaces in the inspection area. This
level of inspection is made under normally available lighting
conditions such as daylight, hangar lighting, flashlight, or
droplight and may require removal or opening of access panels or
doors. Stands, ladders, or platforms may be required to gain
proximity to the area being checked.''

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, Wichita Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
ATTN: Jose Flores, Aerospace Engineer, Electrical Systems and
Avionics, ACE-119W, FAA, Wichita Aircraft Certification Office
(ACO), 1801 Airport Road, Room 100, Mid-Continent Airport, Wichita,
Kansas 67209; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

Related Information

    (i) For more information about this AD, contact Jose Flores,
Aerospace Engineer, Electrical Systems and Avionics, ACE-119W, FAA,
Wichita Aircraft Certification Office (ACO), 1801 Airport Road, Room
100, Mid-Continent Airport, Wichita, Kansas 67209; telephone 316-
946-4133; fax<PHONE_NUMBER>.

Material Incorporated by Reference

    (j) You must use Bombardier Alert Service Bulletin A40-24-11,
dated November 16, 2009; or Bombardier Alert Service Bulletin A45-
24-16, dated November 16, 2009; as applicable; to do the actions
required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of Bombardier Alert Service Bulletin A40-
24-11, dated November 16, 2009; and Bombardier Alert Service
Bulletin A45-24-16, dated November 16, 2009; under 5 U.S.C. 552(a)
and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Learjet, Inc., One Learjet Way, Wichita, Kansas 67209-2942;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet http://www.bombardier.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on February 7, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-3534 Filed 2-23-11; 8:45 am]
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[Federal Register Volume 78, Number 77 (Monday, April 22, 2013)]
[Proposed Rules]
[Pages 23685-23686]
[FR Doc No: 2013-09418]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0153; Directorate Identifier 2010-NM-022-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Proposed rule; withdrawal.

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

SUMMARY: The FAA withdraws a notice of proposed rulemaking (NPRM) that
proposed a new airworthiness directive (AD) for certain The Boeing
Company Model 777-200 and -300 series airplanes. The proposed AD would
have required removing the electrical system control panel, changing
the wiring, installing a new electrical power control panel, and
installing new operational software for the electrical load management
system and configuration database. Since the proposed AD was issued, we
have received new data that indicates the unsafe condition would not be
adequately addressed by the proposed action. Subsequently, we are
considering issuing new rulemaking that positively addresses the unsafe
condition identified in the NPRM and eliminates the need for the
actions proposed in the NPRM. Accordingly, the proposed AD is
withdrawn.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD action, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is the Document
Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Ray Mei, Aerospace Engineer, Systems
and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification
Office,

1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:
425-917-6590; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We proposed to amend part 39 of the Federal Aviation Regulations
(14 CFR part 39) with a notice of proposed rulemaking (NPRM) for a new
AD for certain Model 777-200 and -300 series airplanes. That NPRM
published in the Federal Register on March 8, 2011 (76 FR 12617). The
NPRM would have required removing the electrical system control panel,
changing the wiring, installing a new electrical power control panel,
and installing new operational software for the electrical load
management system and configuration database. The NPRM resulted from an
in-flight entertainment (IFE) systems review. The proposed actions were
intended to ensure that the flightcrew is able to turn off electrical
power to the IFE system and other non-essential electrical systems
through a switch in the flight compartment in the event of smoke or
flames. In the event of smoke or flames in the airplane flight deck or
passenger cabin, the flightcrew's inability to turn off electrical
power to the IFE system and other non-essential electrical systems
could result in the inability to control smoke or flames in the
airplane flight deck or passenger cabin during a non-normal or
emergency situation.

Actions Since NPRM (76 FR 12617, March 8, 2011) Was Issued

    Since we issued the NPRM (76 FR 12617, March 8, 2011), we have
received new data that indicates the unsafe condition would not be
adequately addressed by the proposed action. Subsequently, we are
considering issuing new rulemaking that positively addresses the unsafe
condition identified in the NPRM and eliminates the need for the
actions proposed in the NPRM.

FAA's Conclusions

    Upon further consideration, we have determined that the unsafe
condition still exists, however, we intend to address it with new AD
rulemaking. Accordingly, the NPRM (76 FR 12617, March 8, 2011) is
withdrawn.
    Withdrawal of the NPRM (76 FR 12617, March 8, 2011) does not
preclude the FAA from issuing another related action or commit the FAA
to any course of action in the future.

Regulatory Impact

    Since this action only withdraws an NPRM (76 FR 12617, March 8,
2011), it is neither a proposed nor a final rule and therefore is not
covered under Executive Order 12866, the Regulatory Flexibility Act, or
DOT Regulatory Policies and Procedures (44 FR 11034, February 26,
1979).

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Withdrawal

    Accordingly, we withdraw the NPRM, Docket No. FAA-2011-0153,
Directorate Identifier 2010-NM-022-AD, which published in the Federal
Register on March 8, 2011 (76 FR 12617).

    Issued in Renton, Washington, on February 1, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-09418 Filed 4-19-13; 8:45 am]
BILLING CODE 4910-13-P