[Federal Register: April 10, 2008 (Volume 73, Number 70)]
[Notices]
[Page 19533-19534]
[DOCID:fr10ap08-97]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57613]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Declaration of Effectiveness of the Boston Stock Exchange
Fingerprinting Plan

April 3, 2008.
    On March 27, 2008, the Boston Stock Exchange, Inc. (``BSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a Fingerprint Plan (``Plan'') pursuant to Rule 17f-
2(c) \1\ under the Securities Exchange Act of 1934 (``Act'').\2\ A copy
of the Plan is attached as Exhibit A.
---------------------------------------------------------------------------

    \1\ 17 CFR 240.17f-2(c).
    \2\ 15 U.S.C. 78a et seq.
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    The BSE believes that the Plan will facilitate compliance by
Exchange members with section 17(f)(2) of the Act and Rule 17f-2
thereunder, by providing a facility for the fingerprints of directors,
partners, officers and employees of Exchange members to be submitted to
the Attorney General of the United States or his designee (``Attorney
General'') and processed electronically.
    Under the Plan, all persons who are seeking registration with the
BSE or are currently registered with the BSE submit fingerprints and
identifying information, on paper or electronically, to the Financial
Industry Regulation Authority, Inc. (``FINRA''), which then forwards
the fingerprints to the Federal Bureau of Investigation (``FBI'') (the
fingerprint processing arm of the Attorney General). The FBI identifies
submitted fingerprints, retrieves relevant criminal history
information, and returns fingerprint reports to FINRA. BSE members will
be able to view the status and results of fingerprints, including any
relevant criminal history information, through FINRA's Web Central
Registration Depository (Web CRD[supreg]) system after submission to
the Attorney General.
    FINRA notifies the Exchange if the fingerprint results received by
FINRA contain information indicating that the

person is subject to a statutory disqualification. In such an instance,
the Exchange reviews the fingerprint results to determine the possible
existence of a statutory disqualification as defined in section
3(a)(39) of the Act, and takes appropriate action, if necessary,
concerning eligibility or continued eligibility of the individual for
employment or association with an Exchange member.
    The Commission has reviewed the procedures detailed in the Plan and
believes that the Plan is consistent with the public interest and the
protection of investors. Thus, the Commission declares the Plan
effective.
    The Commission notes that the securities industry fingerprinting
procedures are in a state of flux due to rapidly advancing technology.
In the event that an industry-wide standard is adopted or becomes
prevalent and in the event that this Plan substantially differs
therefrom, the Commission would expect the BSE to revise its
fingerprint plan to incorporate the industry-wide standard.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\3\
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    \3\ 17 CFR 200.30-3(a)(17)(iii).
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Florence E. Harmon,
Deputy Secretary.

Exhibit A

Boston Stock Exchange Fingerprinting Plan

    The Boston Stock Exchange, Inc. (``BSE'' or ``Exchange'') submits
this Fingerprint Plan (``Plan'') pursuant to section 17(f)(2) of the
Securities Exchange Act of 1934 (``Act'') and Rule 17f-2(c) thereunder.
    The purpose of this Plan is to facilitate compliance by Exchange
Members with section 17(f)(2) of the Act and Rule 17f-2(c) thereunder,
by providing a facility for the fingerprints of directors, partners,
officers and employees of Exchange members to be submitted to the
Attorney General of the United States or his designee (``Attorney
General'') and processed electronically.
    The Exchange has established an arrangement with the Financial
Industry Regulation Authority, Inc. (``FINRA''), to permit all
individuals that must be registered with, or approved by, the Exchange
(``registered persons'') to be electronically registered with the
Exchange through FINRA's Web Central Registration Depository (``Web
CRD''). The Web CRD is a Web-based system that provides broker-dealers
and their associated person with ``one-stop filing'' with the
Commission, FINRA and other self-regulatory organizations and
regulators. The Web CRD is operated by FINRA and is used by
participating regulators in connection with registering and licensing
broker-dealers and their associated persons.
    In connection with the arrangement with FINRA, all persons who are
seeking registration with the Exchange or are currently registered with
the Exchange, submit fingerprint cards or fingerprint results to FINRA
for processing and/or submission to the Attorney General. The Attorney
General provides FINRA with fingerprint processing results for persons
seeking registration, and results are provided to the members. FINRA
notifies the Exchange if the fingerprint results received by FINRA
contain information indicating that the person is subject to a
statutory disqualification. In such an instance, the Exchange reviews
the fingerprint results to determine the possible existence of a
statutory disqualification as defined in section 3(a)(39) of the Act,
and takes appropriate action, if necessary, concerning eligibility or
continued eligibility of the individual for employment or association
with an Exchange member.
    The Exchange advises its members and member applicants of any fees
charged in connection with processing of fingerprints pursuant to this
Plan. The Exchange will file any such Exchange member fees with the
Commission pursuant to section 19(b) of the Act.
    Copies of fingerprint reports received from the Attorney General
with respect to fingerprints submitted by the Exchange pursuant to this
Plan will be maintained by the Exchange in accordance with the
Exchange's record retention obligations under the Act. Any maintenance
of fingerprint records by the Exchange shall be for the Exchange's own
administrative purposes, and the Exchange is not undertaking to
maintain fingerprint records on behalf of Exchange members pursuant to
Rule 17f-2(d)(2).
    The Exchange shall not be liable for losses or damages of any kind
in connection with the fingerprint services, as a result of a failure
to properly follow the procedures described above, or as a result of
lost or delayed fingerprint cards, fingerprint records, or fingerprint
processing results, or as a result of any action by the Exchange or the
Exchange's failure to take action in connection with this Plan.

[FR Doc. E8-7506 Filed 4-9-08; 8:45 am]

BILLING CODE 8011-01-P


no
                                      yes
                                      yes
                                      yes
                                       -
                                       -
                                      yes
                                      yes
                                      yes
870.7485    General Metabolism
870.7600    Dermal Penetration
870.7800    Immunotoxicity
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes

A.2	Toxicity Profiles

Table A.2.1	Acute Toxicity Profile - Test Substance
Guideline No.
Study Type
MRID(s)
                                    Results
                               Toxicity Category
870.1100
Acute oral, rat
                                   45639823
LD50= 2804/2000 [M/F]
                                      III
870.1100
Acute Oral, mouse
                                   45639824
LD50=2450/2275 [M/F]
                                      III
870.1200
Acute dermal, rat
                                   45639901
LD50 > 2000 mg/kg
                                      IV
870.1300
Acute inhalation, rat
                                   45639902
LC50 > 4.09 mg/L
                                      IV
870.2400
Acute eye irritation, rabbit
                                   46301601
no positive effects
                                      IV
870.2500
Acute dermal irritation, rabbit
                                   45639904
low level of irritation
                                      IV
870.2600
Skin sensitization, guinea pig
                                   45639905
not a sensitizer
                                      n/a

Table A.2.2	Subchronic, Chronic and Other Toxicity Profile

                           Guideline No./ Study Type

                    MRID No. (year)/ Classification /Doses

                                    Results

870.3100
90-Day oral toxicity in rats

MRID: 45654205, 45654203 (range-finding) (1997)

Acceptable/Guideline

Dose Levels: 0, 500, 5000, 25,000, 50,000 ppm (dietary); M/F= 34/38, 336/384, 1623/1871, 3156/3616 mg/kg/day

NOAEL: 336/384 [M/F] mg/kg

LOAEL: 1623/1871 [M/F] mg/kg/day based on decreased body weight and body weight gain and histopathological lesions of the adrenal glands in female rats

870.3100
90-Day oral toxicity in mice

MRID: 45654206, 45654204 (range-finding) (1997)

Acceptable/Guideline

Dose Levels: 0, 500, 5000, 25,000, 50,000 ppm (dietary); M/F= 81/102, 884/1064, 4442/5414, 10,635/11,560 mg/kg/day

NOAEL: 4442/5414 [M/F] mg/kg/day

LOAEL: 10,635/11,560 [M/F] mg/kg/day, based on decreased body weight and body weight gain

870.3150
90-Day oral toxicity in dogs

MRID: 45639906 (main study), 45639915, 45639916 (range-finding studies) (1999)

Acceptable/Guideline

Dose Levels: 0, 1600, 8000, 24,000 ppm (dietary); M/F= 0, 58/58, 307/323, 862/950 mg/kg/day

NOAEL: 307 mg/kg/day

LOAEL: 862 mg/kg/day, based on decreased body weight gain in males and decreased body weight and body weight gain in females.

870.3200
28-Day dermal toxicity (rats)

MRID: 45639908, 45639907 (range-finding) (2001)

Acceptable/Guideline

Dose Levels: 0, 40, 200, 1000 mg/kg/day

Systemic:
NOAEL: 1000 mg/kg/day

LOAEL: Not Established.

Dermal:
NOAEL: 1000 [M], 200 [F] mg/kg/day

LOAEL: not determined/1000 [M/F] mg/kg/day based on lack of effects in males, and acanthosis/ hyperkeratosis in high dose females (lower doses not evaluated histopathologically).

870.3465
28-Day inhalation toxicity (rat)

MRID: 45639909, 46072401 (2002)

Acceptable/Guideline

Dose Levels: 0, 0.22, 0.66, 2.08 mg/L (nose-only); M/F= 0, 60, 179, 565 mg/kg/day

NOAEL: 2.08 [M/F] mg/L or 565 mg/kg/day; HDT

LOAEL: not identified

Note: The concentration tested is the highest practical concentration obtainable in the respirable range.

870.3700a
Prenatal developmental toxicity study (rats)

MRID: 45654207, 45639910 (range-finding) (1998)

Acceptable/Guideline

Dose Levels: [F] 0, 100, 300, 1000 mg/kg/day

Maternal
NOAEL: 1000 mg/kg/day, HDT
LOAEL:  Not Established

Developmental
NOAEL: 1000 mg/kg/day
LOAEL: Not Established

870.3700b
Prenatal developmental toxicity study (rabbits)

MRID: 45654208 (main study), 45639911, 45639912 (range-finding studies) (1998)

Acceptable/Guideline

Dose Levels: 0, 52, 125, 300 mg/kg/day

Maternal
NOAEL: 125 mg/kg/day
LOAEL: 300 mg/kg/day based on clinical signs indicative of neurotoxicity (i.e., hypoactivity, prone position, tremors)

Developmental
NOAEL: 300 mg/kg/day
LOAEL: Not Established

870.3800
Reproduction and fertility effects (rats)

MRID: 45639913, 45639914 (range-finding) (2002)

Acceptable/Guideline

Dose Levels: 0, 300, 1000, 3000, 10,000 ppm (dietary); M/F: 0, 24.1/26.8, 79.9/90.1, 241.0/267.9, 822.1/907.0 mg/kg/day

Parental/systemic
NOAEL: 241/268[M/F] mg/kg/day
LOAEL: 822/907[M/F] mg/kg/day, based on a transient decrease in food consumption and decreased premating weight gain in F0 males, observations of soft feces in F0 females and decreased thyroid weights in F1 females.

Offspring
NOAEL: 241/268 [M/F] mg/kg/day
LOAEL: 822/907 [M/F] based on decreased body weights, body weight gains, and decreased forelimb grip strength (F1 males) or hindlimb grip strength (F1 females).

Reproductive
NOAEL: 241/268 [M/F] mg/kg/day
LOAEL: 822/907 [M/F] mg/kg/day, based on decreased uterine weights and microscopic alterations in the uterus and vagina of F0 females, decreased numbers of primordial follicles in F1 females, altered estrous cyclicity in F0 and F1 females, slight increases in abnormal sperm morphology in F0 and F1 males, and slight decreases in testicular sperm count in F0 males and sperm motility in F1 males.

870.4100b
Chronic toxicity (dogs)

MRID: 45654209 (1999)

Acceptable/Guideline

Dose Levels: 0, 640, 3200, 16,000 ppm (dietary); M/F= 0, 20/22, 111/108, 559/512 mg/kg/day

NOAEL: 559/512 [M/F] mg/kg/day; HDT
LOAEL: Not Established

870.4200b
Carcinogenicity (mice)

MRID: 45639917 (2000)

Acceptable/Guideline

Dose Levels: 0, 25, 250, 2500, 25,000 ppm (dietary); M/F: 0, 3/4, 34/45, 345/441, 3694/4728 mg/kg/day

NOAEL: 3694/4728 [M/F] mg/kg/day
LOAEL: Not Established

870.4300
Combined chronic toxicity/ carcinogenicity (rats)

MRID: 45640001 (2000)

Acceptable/Guideline

Dose Levels: 0, 60, 200, 2000, 20,000 ppm (dietary); M/F: 3.0/3.9, 9.9/12.5, 99.7/127.3, 991/1332 mg/kg/day

NOAEL: 99.7/127.3 [M/F] mg/kg/day
LOAEL: 991/1332 [M/F] mg/kg/day based on decreased body weight gain and nephrotoxicity.

870.5100
Bacterial reverse mutation test

MRID: 45640003 (1996)

Acceptable

Negative.  +- S9 up to 16,000 ug/plate

870.5100
Bacterial reverse mutation test

MRID: 45654210 (1996)

Acceptable

Negative.  +- S9 up to limit dose of 5000 ug/plate

870.5300
In vitro mammalian cell gene mutation test

MRID: 45640002 (2002)

Acceptable

Negative, +- S9 up to 2002 ug/mL

(Mouse lymphoma L5178Y cells)

870.5375
In vitro mammalian chromosome aberration test

MRID: 45654211 (1996)

Acceptable

Negative for clastogenic/aneugenic activity up to 2000 ug/mL

(CHL/IU cells)

870.5395
In vivo mammalian cytogenics -micronucleus assay

MRID: 45654212 (1995)

Acceptable

Negative at oral doses up to 1080 mg/kg/day for 2 days

870.6200a
Acute neurotoxicity screening battery

MRID: 45640005 (2001)

Acceptable/Guideline

Dose Levels: 0, 325, 750, 1500 [M/F] mg/kg/day

NOAEL: 750 [M], 325 [F] mg/kg/day
LOAEL: 1500 [M], 750 [F] mg/kg/day based on decreases in motor activity in both sexes on Day 1.

870.6200b
Subchronic neurotoxicity screening battery

MRID: 45640004 (2001)

Acceptable/Guideline

Dose Levels: 0, 500, 5000, 50,000 ppm (dietary); M/F= 0, 33/40, 327/400, 3413/3806 mg/kg/day

NOAEL: 33/40 [M/F] mg/kg/day
LOAEL: 327/400 [M/F] mg/kg/day based on decreased motor activity.

870.6300
Developmental neurotoxicity study (rats)

MRID 48291601 (2010)

Acceptable/Guideline

Dose:  0, 1000, 3000 or 10000
Gestation/Lactation = 0, 79.4/158, 237.4/500.7 or 784.1/1642.9 mg/kg/day

Maternal NOAEL: 784  mg/kg/day
Maternal LOAEL: Not Established

Offspring NOAEL = 784 mg/kg/day. Offspring LOAEL: Not Established.

870.7485
Metabolism and pharmacokinetics (rats)

MRID: 45640006

Acceptable/Guideline
Dose: single 50 or 1000 mg/kg oral or 50 mg/kg IV treatments or multiple oral 50 mg/kg treatments with MTI-446 (dinotefuran, >98% a.i., batch numbers VB9304, VB9302 (radiolabeled in the guanidine and furan positions) and 22-00210 & OFU-1265 (unlabeled)

Absorption was > 90% regardless of dose.  The radiolabel was widely distributed through the body and was completely excreted within 168 hours of treatment.  Urine was the primary elimination route, accounting for 88-99.8%.  Excretion into the urine was rapid, being 84-99% complete within 24 hours of treatment.  Absorption of the radioactivity was linear within the dose range of 50 and 1000 mg/kg.  Elimination of radioactivity was fast for all groups with a T(1/2) ranging from 3.64 to 15.2 hours for the low and high doses, respectively. Radioactivity was rapidly transferred from maternal blood to milk and widely distributed in the fetal tissues.  The Cmax for milk and fetal tissues was detected 0.5 hours after maternal treatment.  The concentra - tions of radioactivity in fetal tissue and maternal milk declined quickly and were below detection limits 24 hours post-treatment. After IV or oral treatment, 75- 93% of the administered radiolabeled test material, or nearly 93-97% of total urinary radiolabel, was excreted unchanged in the urine.  The parent compound was also the primary component in the plasma, milk, bile, feces, and most tissues collected 4-8 hours after treatment and at both dose levels.  Less than 10% of the parent compound was metabolized into numerous minor metabolites that were not well resolved by HPLC or 2D-TLC.  For all parameters measured in this study, no sex- or dose-related differences or label position effects were found.

870.7600
Dermal penetration

47013401

A dermal absorption factor (DAF) of 1.71% represents the radioactivity absorbed and remaining on the skin after removal of the stratum corneum, following a 10 hour exposure to 3.2 g/cm[2]

870.7800
Immunotoxicity in Rats
MRID 48442101 (2010)

Acceptable/Guideline

Dose:  0, 2240, 5600 or 14000 ppm
M/F= 0, 164/179, 425/430, 992/1018 mg/kg/day

Systemic
NOAEL: 425/430 [M/F] mg/kg/day.
LOAEL:  992/1018 [M/F] mg/kg/day based on decreased body weight, body weight gain, and food consumption.
Immunotoxicity
NOAEL: 992/1018 [M/F] mg/kg/day  LOAEL: Not Established

870.7800
Immunotoxicity in Mice
MRID 48442102 (2010)

Acceptable/Guideline

Dose:  0, 1120, 2800 or 7000 ppm
M/F= 0, 153/223, 405/581, 1053/1438 mg/kg/day
Systemic
NOAEL: 1053/1438 [M/F] mg/kg/day.
LOAEL: Not Established

Immunotoxicity
NOAEL: 1053/1438 [M/F] mg/kg/day.
LOAEL: Not Established

Special study:
Neonatal rat metabolism study (12-day old rat pups)

MRID: 45640007

Acceptable/Non-guideline

Dose: 50 mg/kg radiolabeled MTI-446 (dinotefuran, Lot No. VB9304, labeled on the central guanidine portion of the mole - cule, purity and radio purity >99%

After a single oral 50 mg/kg dose of [G-[14]C] MTI-446 to 12-day-old rats, absorption was high (absorption could not be adequately determined but may have approached 80%) and the radio - label was widely distributed within the body.  Approximately 32-36% of the administered dose was excreted within 4 hours of treatment.  Urine was the primary elimination route as indirectly evidenced by finding high radioactive areas in the kidneys and bladder by whole body autoradiography.  No areas of tissue seques - tration were found and no gender-related differences were identified.  The test material was essentially not metabolized, the parent compound accounting for >97% of the radiolabel in the excreta, plasma, kidneys, and stomach, and nearly 61-83% in intestines (and contents), and liver.
Special study:
Developmental Immunotoxicity Study in Rats
MRID: 47677501

Acceptable/Non-guideline

Dose: 0, 1000, 3000 or 10000 ppm which are equivalent to 0, 105.4, 317.8 or 1035.4 mg/kg/day, respectively.
Maternal
NOAEL: 1035.4 mg/kg/day.
LOAEL: Not Established

Offspring
NOAEL: 317.8 mg/kg/day.
LOAEL: 1035.4 mg/kg/day based on decreased pup body weight.

Immunotoxicity
NOAEL: 1035.4 mg/kg/day.
LOAEL: Not Established

Appendix B.  Physical/Chemical Properties

TABLE B.  Physicochemical Properties of the Test Compound: Dinotefuran.
Parameter
Value
Reference (MRID)
Melting point/range
107.5ºC
45639702
pH
5.6 @ 25ºC
45654201
Density
1.40 g/cm[3] @ 20ºC
45639702
Water solubility ( 20°C)
39.83 x 10[3] mg/L (pH 6.98)
45639702
Solvent solubility (mg/L at 20°C)
                               g/100 mL Solvent
45639702

Hexane
9 x 10[-7]

Heptane
1.05 x 10[-6]

Xylene
0.0072

Toluene
0.0149

Dichloromethane
6.45

Acetone
6.13

Methanol
6.00

Ethanol
2.01

Ethyl Acetate
0.52

Vapor pressure at 30°C
< 1.7 x 10[-6] Pa @ 25ºC
45639702
Dissociation constant (pKa)
12.6 @ 20ºC (estimated)
45639702
Octanol/water partition coefficient Log(KOW)
-0.549 (Kow = 0.283) @ 25ºC
45639702
UV/visible absorption spectrum
Media
Absorbance Maximum 268 nm
Euromax: Molar
Absorbance Coefficient
45639702

Acidic
1.0469
12,600

1.0180
12,300

Neutral
1.3017
12,500

1.2668
12,300

Basic
0.8869
10,700

0.9662
11,700

 Appendix C.  International Residue Limit Status Sheet.

                 Dinotefuran (044312, Requested 25April, 2012)
Summary of US and International Tolerances and Maximum Residue Limits
Residue Definition:
US
Canada
Mexico[2]
Codex[3]
40 CFR 180.603:
Plant:  Combined residues of dinotefuran, ( RS )-1-methyl-2-nitro-3-((tetrahydro-3-furanyl)methyl)guanidine, and its metabolites DN, 1-methyl-3-(tetrahydro-3-furylmethyl)guanidine, and UF, 1-methyl-3-(tetrahydro-3-furylmethyl)urea
Livestock:  Residues of dinotefuran
None

None
Commodity[1]
Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US
Canada
Mexico[2]
Codex[3]
Rice, grain
9

Egg
0.01

Poultry, meat byproducts
0.01

Food/
Feed Handling Establishments
0.01

 Completed: M. Negussie; 04/27/2012
[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains.  PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

Appendix D.  Dinotefuran and Metabolites

Common name/code

Chemical name

Chemical structure

Dinotefuran; MTI-446

N-methyl-N'-nitro-N˝-[(tetrahydro-3-furanyl)-methyl]-guanidine

N
H
N
N
H
O
C
H
3
N
O
2

UF

1-methyl-3-(tetrahydro-3-furylmethyl)-urea

N
H
O

N
H
O
C
H
3

\* MERGEFORMAT
DN

1-methyl-3-(tetrahydro-3-furylmethyl)-guanidine

N
H
N H
N
H
O
C
H
3

\* MERGEFORMAT
PHP
6-hydroxy-5-(2-hydroxyethyl)-1-methyl-1,3-diazinane-2-ylidene-N-nitroamine

FNG
2-nitro-1-(tetrahydro-3-furylmethyl)guanidine

MNG
2-nitro-1-methylguanidine

Appendix E.  Review of Human Research

Studies reviewed for ethical conduct:

The PHED Task Force, 1995. The Pesticide Handlers Exposure Database, Version 1.1. Electronic Database. Task Force members Health Canada, U. S. Environmental Protection Agency, and the National Agricultural Chemicals Association, released February, 1995.

The Agricultural Handler Exposure Task Force (AHETF), 2011.  The Occupational Handler Unit Exposure Surrogate Reference Table.  U.S. Environmental Protection Agency. Released June 21, 2011.

Data from the Outdoor Residential Exposure Task Force (ORETF).