impairment indicative of constricted bronchioles. Exposure to 10 or 100
mg/m3 together with 0.01 and 0.1 mg/m3 enzyme dust produced the same
effects along with weight loss and decreased weight gain.

Developmental Toxicity

870.3700a

Developmental Toxicity (rodent)	Daly et al. (1980) A Teratology Study of
Topically Applied LAS in Rats, Fd. Cosmet. Toxicol. 18: 55-58.  (HERA)

Open Literature	LAS was applied to the skin on days 0 through 21 of
gestation at doses of 20, 100, and 400 mg/kg bw/d

Rat

Purity: Not Reported	NOAEL (maternal): 20 mg/kg bw/d

NOAEL (fetuses): 400 mg/kg bw/d

Maternal toxicity: the dams treated with 400 mg/kg bw/day and 100 mg/kg
bw/day showed inhibition

of body weight gain and llocal skin effects that compromised the
integrity of the skin and caused

overt toxicity, like inhibition of the body weight gain.

Teratogenicity: there were no findings indicative of effects of LAS on
the foetal parameters evaluated.

There were no indications of teratogenic or embryotoxic effects.

870.3700a

Developmental Toxicity (rodent)	Endo et al. (1980) Studies of the
Chronic Toxicity and Teratogenicity of Synthetic Surfactants, Ann. Rep.
Tokyo Metrop. Res. Inst. Environ. Prot. (Tokyo Kogai Kenkyujo Nempo),
236-246.  (HERA)

Open Literature	LAS was administered in the drinking water at 0.1%,
corresponding to 383 mg/kg bw/d for rats and up to 3030 mg/kg bw/d for
rabits from day 6 to 15 (rats) and day 6 to 18 (rabbits) of pregnancy.

F Rat and Rabbit

Purity: Not Reported	NOAEL (maternal): 383 mg/kg bw/d (rat)

LOAEL (maternal): 3030 mg/kg bw/d (rabbit)

NOAEL (fetuses): 383 mg/kg bw/d (rat)

LOAEL (fetuses): 3030 mg/kg bw/d (rabbit)

The effect on the dams was a slight inhibition of body weight gain in
the rabbits. The litter parameters of both species did not show any
significant differences from those of the controls. Delayed ossification
was observed in rabbits, but there was no increase in malformations in
either the rabbits or the rats.

870.3700a

Developmental Toxicity (rodent)	Imahori et al. (1976) Effects of LAS
Applied Dermally to Pregnant Mice on the Pregnant Mice and their
Fetuses, J. Jpn. J. Public Health (Nihon Koshueisei Zasshi) 23(2):
68-72.  (HERA)

Open Literature	LAS was applied daily at dermal doses of 15, 150, and
1500 mg/kg bw/d on days 6 through day 15 of pregnancy

F Mouse

Purity: Not Reported	NOAEL (maternal): 150 mg/kg bw/d

NOAEL (fetuses): 1500 mg/kg bw/d

The 1500 mg/kg bw/day group showed a clear decrease in the pregnancy
rate (67.9%) when

compared with a rate of 96.3% in the controls. However, there were no
decreases in the litter size, and

no changes in the litter parameters with the exception of a slight
decrease in foetal body weight. There

were no significant increases in the incidence of malformations in the
foetuses.

870.3700a

Developmental Toxicity (rodent)	MRID No. 43498423

Masuda et al. (1974) Effects of LAS Applied Dermally to Pregnant Mice on
the Development of their Fetuses.  15: 349-355.

Acceptable

Guideline	LAS was applied dermally at a level of 0.5 ml.  The ICR-JCL
strain received doses of 0, 0.85, 1.7, 2.55, and 3.4% solutions daily
from days 1 to 13 of gestation and the ddY strain received doses of 0,
0.017, 0.17, and 1.7% solutions daily from days 2 to 14 of gestation.

Mouse (ICR-JCL strain and ddY strain)

Purity: Not Reported	NOEL (maternal and developmental toxicity - ddY):
1.7% (HDT)

NOEL (maternal toxicity - ICR-JCL): 2.55%

NOEL (developmental toxicity - ICR-JCL): 1.7%

At 3.4% LAS, maternal body weight and the absolute weight of liver,
kidney, spleen were significantly increased over control.. Pregnancy
rates were significantly less (33.35) compared to controls (69%).

The number of implantations, live fetuses, sex ratio, dead or resorbed
fetuses, placenta weight and external malformations  were comparable
with control. Fetal body weights of 2.55% and 3.4% LAS-treated groups
were significantly less than controls.

870.3700a

Developmental Toxicity (rodent)	MRID 43498424 and 43498425

Nomura, T et al. (1980) The Synthetic Surfactants AS and LAS Interrupt
Pregnancy in Mice.  Life Sciences, 26: 49-54.  (HERA)

Nomura, T. et al. (1987) Killing of Preimplantation Mouse Embryos by AS
and LAS. Mutation Research 190: 25-29.  (HERA)

Acceptable

Guideline	LAS (0.1 ml ) was applied at a concentration of 20% to the
dorsal skin of pregnant mice during the pre-implantation period  twice a
day from day 0 to day 3 of pregnancy

Female  ICR/Jcl Mouse,

9-10 weeks old

Purity: 20%	Development was retarded and cleavage of eggs was
interrupted.  Significantly higher numbers of embryos were found to be
deformed in the LAS group in comparison to controls, and most of these
embryos were in the morula stage, whereas they were mostly in the last
blastocyst stage in controls.

Some dead, deformed, and growth-retarded embryos were observed in the
treated group.  Although the authors stated that these effects were not
due to maternal toxicity since no maternal organs were affected, this
statement is probably not correct in view of the high concentration of
LAS and its irritation effects.  A secondary effect due to maternal
toxicity appears much more likely.

870.3700a

Developmental Toxicity (rodent)	MRID 43498426

Palmer et al. (1975) Assessment of the Teratogenic Potential of
Surfactants, (Part I), Toxicology 3: 91-106.

Acceptable

Guideline	LAS was administered by gavage on days 6-15 of pregnancy in
rats and mice and days 6-18 of pregnancy in rabbits at doses of 0.2, 2,
300, and 600 mg/kg bw/d

20 CD Rats, 20 CD-1 Mice, and 13 New Zealand White Rabbits

Purity: 17%	NOAEL (rat - maternal): 300 mg/kg bw/d

NOAEL (mouse - maternal): 2.0 mg/kg bw/d (However, there is a large
difference between this dose and the next highest dose of 300 mg/kg
bw/d, this study does not allow determination of a reliable maternal
NOAEL for mice)

NOAEL (rabbit - maternal): 2.0 mg/kg b/d (However, the study does not
allow determination of reliable NOAELs, given the large difference
between the maternal no-effects doses of 2 mg/kg bw/d and the maternal
LOAEL dose (300 mg/kg bw/d) that is also the dose for which effects on
litters could not be determined due to the high mortality rate in parent
animals)

NOAEL (rat - developmental): 300 mg/kg bw/d

NOAEL (mouse - developmental): 2.0 mg/kg bw/d

NOAEL (rabbit - developmental): 2.0 mg/kg bw/d

NOAEL (rat - fetal): 600 mg/kg bw/d

NOAEL (mouse - fetal): 300 mg/kg bw/d  (Due to a high mortality rate of
parent animals, no assessment was possible at 600 mg/kg bw/d)

NOAEL (rabbit - fetal): could not be determined

870.3700a

Developmental Toxicity (rodent)	MRID 43511403

Palmer, et al. (1975) Assessment of the Teratogenic Potential of
Surfactants, (Part III) - Dermal Application of LAS and Soap.
Huntingdon Research Centre, Huntingdon, Great Britain.  Study No. DDBSA
JV-RP4-029.  Toxicology 4: 171-181.

Acceptable

Guideline	LAS was administered percutaneously to shaved skin at
solutions of 0.03%, 0.3%, and 3% during pregnancy on days 2-13 in mice,
2-15 in rats, and 1-16 in rabbits.  Dosages employed were 0.5 ml/rat or
mouse/day and 10 ml/rabbit/day

CD-1 Mice (20/group), CD Rats (20/group), N2W Rabbits (13/group)

Purity: 0.03%, 0.3%, and 3%	LOEL (maternal toxicity, mice): 0.3% (50
mg/kg/d)

LOEL (maternal toxicity, rats): 3.0% (60 mg/kg/d)

LOEL (maternal toxicity, rabbits): 0.3% (9.0 mg/kg/d)

NOEL (maternal toxicity, mice): 0.03% (5.0 mg/kg/d)

NOEL (maternal toxicity, rats):  0.3% (6.0 mg/kg/d)

NOEL (maternal toxicity, rabbits): 0.03% ((0.9 mg/kg/d)

LOEL (developmental toxicity): 0.3% (50 mg/kg/d)

LOEL (developmental toxicity): 3.0% (60 mg/kg/d)

LOEL (developmental toxicity): 3.0% (90 mg/kg/d)

NOEL (developmental toxicity): 0.03% (5.0 mg/kg/d)

NOEL (developmental toxicity): 0.3% (6.0 mg/kg/d)

NOEL (developmental toxicity): 0.3% (9.0 mg/kg/d)

Marked local skin reaction, irritability, weight loss and failure to
maintain or establish pregnancy was evident in mice treated with LAS 3%
soap, 3 or 30%: marked local reaction and weight loss also occurred in
rabbits receiving LAS 3%.

Moderate maternal toxicity was observed among mice treated with LAS,
0.3% and mild maternal toxicity in rats receiving LAS 3% or soap 30% and
rabbits receiving LAS 0.3%.

Effects on litter parameters were dose-dependent,  causing marked
maternal toxicity in mice, the principal  higher fetal loss,  reduction
in viable litter size.

LAS at 3% showed marked maternal toxicity in the rabbit

The moderate maternal toxicity of LAS, 0.3% in the mouse correlated with
a higher incidence of embryonic deaths and lower litter size but only
the former differed significantly from the corresponding control value.

870.3700a

Developmental Toxicity (rodent)	Sato et al. (1972) Studies on the
Toxicity of Synthetic Detergents: (III), Examination of Teratogenic
Effects of Alkylbenzene Sulfonates Spread on the Skin of Mice. Ann. Rep.
Tokyo Metrop. Res. Lab. Public Health 24: 441-448.  (HERA)

Open Literature	LAS was applied to the skin of female mice daily on days
0 through 13 of pregnancy with a single LAS dose of 110 mg/kg bw/d.
Control group not specified.

F Mouse

Purity: Not Reported	NOAEL (maternal): 110 mg/kg bw/d

No abnormalities were seen in the dam or foetuses.

870.3700a

Developmental Toxicity (rodent)	Shiobara S., Imahori A. (1976) Effects
of LAS Orally Administered to Pregnant Mice on the Pregnant Mice and
their Fetuses.  J.Food Hyg. Soc. Jpn. (Shokuhin Eiseigaku Zasshi) 17(4):
295-301.

Open Literature	LAS was administered by gavage at doses of 10, 100, and
300 mg/kg bw/d at day 6 through 15 of gestation

ICR-SLC Mouse (25-33/dose)

Purity: Not Reported	LOAEL (maternal): 10 mg/kg bw/d

NOAEL (fetuses): 300 mg/kg bw/d

1.  Marked maternal and embryonic toxicities, such as maternal death,
premature delivery, total litter loss and high fetal death rate, were
observed at 300 mg/kg group.

2.  Slight suppression of maternal body weight gain and slight body
weight suppression of live fetuses were observed in each treated group.

3.  External malformations such as cleft palate and exencephaly were
observed sporadically both in the control and the treated groups.
However, the incidence of these malformations was not significant, and
considered to be within the spontaneous incidence of ICR mice.

870.3700a

Developmental Toxicity (rodent)	Takahashi et al. (1975) Teratogenicity
of Some Synthetic Detergent and LAS. Ann. Rep. Tokyo Metrop. Res. Lab.
Public Health 26(2): 67-78.  (HERA)

Open Literature	LAS doses of 40, and 400 mg/kg bw/d were administered
daily from day 0 to day 6 of pregnancy or from day 7 to 13 of pregnancy
by gavage

Mouse (13-14/group)

Purity: not reported	NOAEL (maternal): 40 mg/kg bw/d

NOAEL (fetuses): 400 mg/kg bw/d

At 400 mg/kg bw/day, the pregnancy rate was 46.2% compared to 92.9% in
the controls. There was no

increase in malformations. Although no information on maternal toxicity
is available, it appears

likely that maternal toxicity was present at the high dose group.

870.3700a

Developmental Toxicity (rodent)	Tiba et al. (1976) Effects of LAS on
Dam, Fetus, and Newborn Rat. J. Food Hyg. Soc. Jpn. (Shokuhin Eiseigaku
Zassh) 17(1): 66-71.  (HERA)

Open Literature	LAS was administered in the diet at doses of 80 and 780
mg/kg bw/d from day 0 to 20 of gestation

F Rat (16/dose)

Purity: Not Reported	NOAEL (maternal): 780 mg/kg bw/d

NOAEL (fetuses): 780 mg/kg bw/d

At 780 mg/kg bw/day there were no abnormalities in the body weight gains
of the dams, or in the occurrence and maintenance of pregnancy. The
values of the litter parameters did not differ from those of the
controls and there was no evidence of teratogenicity. The number of
offsprings was rather low in the highest dose group, and the weaning
rate of 78.3% was lower than the 100% rate observed in the controls.
However, there

were no abnormalities in body weight gain, organ weights or functions in
the offsprings.

Reproduction Toxicity

870.3800

Reproduction

	MRID 43498416

Buehler, E., Newmann, E., and King, W.  (1971) Two Year Feeding and
Reproduction Study in Rats with Linear Alkylbenzene Sulfonate (LAS).
Tox. Appl. Pharm. 18: 83-91.  (HERA)

Acceptable

Guideline	LAS was administered in the diet at doses of 0, 0.02, 0.1, and
0.5% , equivalent to (0, 10, 50, 250 mg/kg bw/day) for 84 days.

Weanling Charles River CD Rat (20/sex/dose)

Purity: 98.1%	NOAEL Parental: 250 mg/kg bw/day

NOAEL Offspring: 50 mg/kg/d.

The LOAEL of 250 mg/kg/day in the offspring is due to slight
(non-significant) changes in hematology and histopathology and slight
decrease in day 21 body weights.

870.3800

Reproduction

	Endo et al. (1980) Studies of the Chronic Toxicity and Teratogenicity
of Synthetic Surfactants, Ann. Rep. Tokyo Metrop. Res. Inst. Environ.
Prot. (Tokyo Kogai Kenkyujo Nempo), 236-246.  (HERA)

Open Literature	LAS was administered at 70 mg/kg bw/day in the drinking
water  in a four generation rat study.

M/F Wistar Rat

Purity: Not Reported	NOAEL: > 70 mg/kg (only dose tested)

No effects of LAS administration were observed

870.3800

Reproduction

	Palmer et al. (1974)  Effect of CLD Reproductive Function of Multiple
Generations in the Rat, Report LFO10/731029, Unpublished results.
(HERA)

Open Literature	A commercial light duty liquid detergent of LAS (17%)
and alkyl ethoxylate sulphate (7%)  was continuously administered in the
diet for three generations 60 days prior to mating at concentrations of
0, 40, 200, and 1000 mg/kg bw/d.  The corresonding administration of LAS
was of 0, 6.8, 34, and 170 mg/kg bw/d.

Rat

Purity: 17%	NOAEL: 170 mg/kg bw/d

Among parental animals over the three

generations there were no signs of adverse effects of treatment. Food
consumption and bodyweight

changes showed no consistent relationship to dosage. Necroscopy revealed
no changes due to treatment. The mating performance, the pregnancy rate
and the duration of gestation were unaffected.

Among litter parameters, organ weight

analysis, histopathology and skeletal staining of representative young
from the F3b generation

revealed no changes that could be conclusively related to treatment.

Chronic Toxicity

870.4100a Chronic Toxicity (rodent)	Taniguchi et al. (1978) Results of
Studies on Synthetic Detergents.  Tokyo, Science and Technology Agency,
Research and Coordination Bureau, pp. 18-54.  (WHO 1996)

Open Literature	LAS were applied to the dorsal skin of rats three times
per week at doses of 1, 5, or 25 mg/rat for 24 months.  Each application
was washed from the skin with warm water after 24 hours.

SLC-Wistar Rats

Purity: 19.7% a.i.	Treatment had no effect on organ weights or
histopathological appearance, and there was no evidence of toxicity or
carcinogenicity.

870.3100

Chronic Toxicity

(rodent)	Yoneyama et al. (1976) Subacute Toxicity of LAS, Ann. Rep.
Tokyo Metrop. Res. Lab. Public Health27(2): 105-112, See: IPCS, 1996.
(HERA)

Open Literature	LAS was administered in the diet at concentrations of
500 and 1000 mg/kg bw/d and in drinking water at concentrations of 100,
250, 600 mg/kg bw/d for males and 100, 250, 900 mg/kg bw/d for females
for 9 months

Mouse (8 or 9/sex/dose)

Purity: Not Reported	LOAEL: 500 mg/kg bw/d (in diet)

NOAEL: 250 mg/kg bw/d (in water)

LAS in diet: in the mice given 500 mg/kg bw/day, body weight gain was
not suppressed, but the

weight of the liver increased in male and female mice. Enzymatic
examinations revealed significant

decreases in LDH of the liver and in acid phosphatase of the kidneys in
the male mice.

LAS in drinking water: body weight was depressed at the highest dose for
male and females, increase in liver weight in females, significant
decreases in renal Na,K-ATPase.

870.3100

Chronic Toxicity

(rodent)	Yoneyama et al. (1976) Subacute Toxicity of LAS, Ann. Rep.
Tokyo Metrop. Res. Lab. Public Health27(2): 105-112,  See: IPCS, 1996.
(HERA)

Open Literature	LAS was administered for 9 months in the drinking water
at doses of 85, 145, 430 mg/kg bw/day

M/F Wistar Rat

Purity: Not Reported

	NOAEL: 85 mg/kg bw/d

LOAEL: 145 mg/kg bw/d

Haematological examination revealed no significant changes in any
experimental group and no organ

weight changes were observed. Body weight gain was suppressed in the
males of the highest dose

group and also serum-biochemical and enzymatic parameters of the liver
and kidney were affected. A

significant decrease in renal Na,K-ATPase was seen in the group given
145 mg/kg bw/day of LAS.

870.4100a Chronic Toxicity (rodent)	Yoneyama et al. (1972) Studies on
the Toxicity of Synthetic Detergents.  (II) Subacute Toxicity of Linear
and Branched Alkyl Benzene Sulfonates in Rats.  Ann Rep Tokyo Metrop Res
Lab Public Health, 24: 409-440.

Open Literature	Technical-grade LAS was administered in the feed for 6
months at a concentration of 0, 0.07, 0.2, 0.6, or 1.8%

Wistar SLC Strain Rat (10/sex/dose)

Purity: Not Reported	NOAEL: 0.07% (40 mg/kg bw/day)

At 1.8%, diarrhea, decrease in body weight gain and tissue damage in
caecum liver and kidney were observed.  The damage to the kidney was
especially remarkable.

At 0.6% of the LAS or ABS, the adverse effects observed were a slight
decrease of body weight, increase of ceacum weight, increased activity
of alkaline phosphatase, decrease of total protein in blood, and the
tissue damage in the kidney.

At 0.2% of the LAS or ABS, an increase of caecum weight and a slight
damage to the kidney were observed.

Carcinogenicity

870.4200a Oncogenicity (Rat)	MRID 43498416

Buehler, E., Newmann, E., and King, W.  (1971) Two Year Feeding and
Reproduction Study in Rats with Linear Alkylbenzene Sulfonate (LAS).
Tox. Appl. Pharm. 18: 83-91.  (HERA)

Acceptable

Guideline	LAS was administered in the diet at doses of 10, 50, and 250
mg/kg/day for 2 years

Weanling Charles River CD Rats (50/sex/group)

Purity: Not Reported	Negative at 250 mg/kg/day (HDT)

870.4200a

Oncogenicity (Rat)	Endo et al. (1980) Studies of the Chronic Toxicity
and Teratogenicity of Synthetic Surfactants, Ann. Rep. Tokyo Metrop.
Res. Inst. Environ. Prot. (Tokyo Kogai Kenkyujo Nempo), 236-246.  (HERA)

Open Literature	LAS was administered in the drinking water at the dose
of 200 mg/kg bw/d

62 M/F Wistar Rat

Purity: 38.74% a.i.	The administration of LAS had no effect on the
intake of water, mortality, body weight gain, or general condition.  In
pathological examinations, looseness, atrophy, and fatty change of the
hepatic cells in the liver were found in the experimental control group
at 6 months, together with significant increases in GOT, GTP and
bilirubin.  In hematological examinations no effects due to LAS were
observed.

870.4200a

Oncogenicity (Rat)	Fujii et al. (1977) Pathological Examination of Rats
Fed with LAS for their Lifespan, Ann. Rep. Tokyo Metrop. Res. Lab.
Public Health 28(2): 85-108. (HERA)

Yoneyama et al. (1977) Toxicity of LAS by Dietary Administration for
Life-Span to Rats, Ann. Rep. Tokyo Metrop. Res. Lab. Public Health
28(2): 73-84.  (HERA)

Open Literature	LAS was administered in the feed at a concentration of
0.04, 0.16, and 0.60% for  24 months or lifespan

Wistar Weanling Rat (15/sex/dose)

Purity: Not Reported	Histopathological examination revealed that there
was no evidence of a treatment-related effect on any tissue examined.
Whereas a variety of tumors were observed in both linear alkylbenzene
sulfonate treated and control rats, none was attributed for the exposure
to linear alkylbenzene sulfonate.  There was no relationship among the
dosage groups, sex, type of tumor, or the site of occurrence.

870.4200a

Oncogenicity (Rat)	MRID 43498420

Takahasi et al. (1969) Effect of Alkylbenzenesulfonate as a Vehicle for
4-Nitroquinoline-1-Oxide on Gastric Carcinogenesis in Rats.  GANN: 8,
241-261.

Acceptable

Guideline	For 560 days; Group I (79 rats): 1 mg 4-NQO and 80 mg SDDBS
2-3x per week for 18 weeks; Group I' (17 rats): same as Group 1, but
fasted for 12 hours prior to dosing,; Group II (37 rats):  1 mg 4-NQO
only; Group III (28 rats): 80 mg SDDBS only

 97 M Wistar Rats

Purity: Not Reported	In Groups I and I', the presence of SDDBS shifts
the incidence of benign papillomas to malignant papillomas of the
forestomach and the incidence of adenocarcinoma and sarcoma of the
stomach were increased in comparison to Group II with only 4-NQO.  The
administration of SDDBS by itself has no effect on gastric tumors (Group
III).  The study authors concluded that the increased carcinogenicity
produced by SDDBS was due to the better uptake of 4-NQO via LAS's
surfactive/detersive effects on the protective mucous barrier which is
normally found in the glandular stomach and other gastric compartments
of the rat.  The effect of SDDBS was physical rather than chemical in
promoting the increased tumorigenicity.

870.4200a

Oncogenicity (Rat)	MRID 43498419

Takahasi et al. (1970) Effect of 4-Nitroquinoline-1-Oxide with
Alkylbenzenesulfonate on Gastric Carcinogenesis in Rats.  GANN: 61,
27-33.

Acceptable

Guideline	Rats were divided into three groups and gavaged with the
following regimen for 560 days: Group I (37 rats) - 1 mg 4-NQO + 80 mg
SDDBS + 20 mg ethanol in a 1 ml gavage for 18 weeks; Group II (13 rats)
- 4-NQO and ethanol for 18 weeks; Group III (13 rats) - SDDBS + ethanol
for 18 weeks

64 M Motoyama Strain Rat

Purity: Not Reported	Survival: Mortality was 59% in Group I, 31% in
Group II, and 23% in Group III

Tumors: Group III - no gastric tumors; Group II - 9 benign papillomas of
forestomach; Group I - 8 benign papillomas of forestomach, 2 malignant
papillomas of forestomach, 1 hemangiosarcoma of forestomach.  In
glandular stomach, 2 adenocarcinomas, 1 hemangiosarcoma, 1 hemangioma, 5
squamous cell carcinomas, and 2 rats exhibited atrophic gastritis.

The increased toxicity in Group I produced increased mortality and
increased numbers of malignant tumors.  The role of SDDBS in the
tumorigenesis of 4-NQO was to promote increased absorption of 4-NQO
through the forestomach and glandular stomach.

870.4200a

Oncogenicity (Rat)	MRID 43498421, -22

Takahasi et al. (1973) Carcinogenic Effect of
N-Methyl-N'-Nitro-N-Nitrosoguanidine with Various Kinds of Surfactant in
the Glandular Stomach of Rats.

Acceptable

Guideline	SDDBS was administered to 5 groups of rats: (I) 13 rats
received 0.1g of MNNG + 4000 mg Tween 60 per L of drinking water for 36
weeks; (II) 16 rats received 0.1 g MNNG + 2000 mg nonipol per L of
drinking water for 36 weeks; (III) 15 rats received 0.1 g of MNNG + 1000
mg branched ("hard") SDDBS per L of drinking water for 63 weeks; (IV) 10
rats received 0.1 g MNNG + 1000 mg of linear ("soft") SDDBS per L of
drinking water for 63 weeks; (V) 14 rats received o.1 g MNNG per L of
drinking water for 63 weeks

M Wistar Rats

Purity: Not Reported	Survivial was 100% in Groups I, III, and IV, and
93% and 94% in Groups V and II, respectively.

The Group I and II rats had more tumors than the controls (Group V),
whereas, the rats in Group III, ("hard" SDDBS, and particularly, Group
IV (linear "soft" SDDBS) had the fewest tumors in comparison to
controls.

870.4200a

Oncogenicity (Rat)	Tiba S (1972) Studies on the Acute and Chronic
Toxicity of LAS, J. Food Hyg. Soc. Jpn. (Shokuhin Eiseigaku Zasshi)
13(6): 509-516.  (HERA)

Open Literature	LAS was administered in drinking water for 2 years at
doses of 20, 100, and 200 mg/kg bw/d

M Wistar Rat (20/group)

Purity: Not Reported	There were no changes due to the administration of
LAS in regard to growth, mortality, the weight of major organs, or
histopathological findings

Mutagenicity

870.5100 Bacterial reverse mutation test	Huls, Report No. AM-93/12,
Unpublished data, 1993.  (As cited in HERA-2004)

Open Literature	LAS was tested at 8-5000 ug/plate with and without
metabolic activation. The cytotoxicity concentration was  >5000
ug/plate.

Salmonella typhimurium, strains TA 98, TA 100, TA 1535, TA 1537, and TA
1538

Purity: Not Reported	Negative results

870.5100 Bacterial reverse mutation test	MRID 43498429

Inoue et al. (1980)  Studies of In Vitro Cell Transformation and
Mutagenicity by Surfactants and other Compounds, Food. Cosmet. Toxicol
18: 289-296.  (HERA)

Acceptable

Guideline	SDDBS was tested at cytotoxic levels or limit concentrations
of 2,000-30,000 ug/plate for 2 days (Salmonella) or 8 days (SHE)

Strain: Salmonella typhimurium - TA 98 and TA 100 cells and Embryonic
Syrian Golden Hamster cells (SHE)

Purity: Not Reported	Negative (both with and without S-9 metabolic
activation)

870.5100 Bacterial reverse mutation test	Sunakawa et al. (1981) Studies
on the Mutagenicity of Surfactants Following Activation with Various
Liver Homogenates (S-9) and Mutagenicity in the Presence of Norharman,
Hyg. Chem. (Eisei Kagaku) 27(4): 204-211, See: WHO, 1996.

Open Literature	LAS was tested at up to 500 ug/plate

Salmonella typhimurium

Purity: Not Reported	Negative Results

870.5300

In Vitro mammalian cell gene mutation test	Inoue, K. et al. (1977)
Osaka-furitsu Koshu Eisei Kenkyusho Kenkyu Hokoku, Shokuhin Eisei Hen 8:
25-8.  (HERA)

Open Literature	Sodium alkylbenzenesulfonate was added to culture at
62.5 ug/ml and 125 ug/l

Hamster Lung Cell

Purity: Not Reported	At 62.5 ug/ml: induced cell mutation, no effect on
sister chromatid exchange

At 125 ug/ml: destroyed the cells completely

870.5300

 In Vitro cell transformation

	MRID No. 43498427

K. Inoue et al (1980)

Food Cosmetic Toxicol.

18:289-296

Acceptable

Open Literature	Duplicate primary cultures of embryonic SHE and
Salmonella typhimurium strain TA 98 and TA 100 cells were exposed to
SDDBS and positive and negative controls for 8 days.	SDDBS was negative
for transformation up to cytotoxic levels and did not induce mutation in
either strains of Salmonalla when allplied up to cytotoxic levels or
limit concentration of 2000-3000 ug/plate.

SDDBS was tested negative at cytotoxic levels or limit concentrations
(both with and without S-9 metabolic activation) of 2,000-30,000
ug/plate for 2 days (Salmonella) or 8 days (SHE)

870.5385

Mammalian bone marrow chomosomal aberration test	Inoue K, et al. (1979)
In vivo Cytogenetic Tests of Some Synthetic Detergents in Mice, Ann.
Rep. Osaka Perfect. Inst. Public Health 8: 17-24 (in Japanese), See:
IPCS, 1996.  (HERA)

Open Literature	LAS was administered at doses of 200, 400, and 800 mg/kg
bw/d by gavage for 1 and 5 days

M Mouse

Purity: Not Reported	There was no significant difference in the
incidence of chromosomal aberrations between any of the groups

870.5385

Mammalian bone marrow chomosomal aberration test	Inoue, K. et al. (1977)
In Vivo Cytogenetic Tests of Some Synthetic Detergents in Mice.  Ann Rep
Osaka Prefect Inst Public Health, 8: 17-24.  (HERA)

Open Literature	LAS was administered at a dose of 200, 400, and 800
mg/kg bw/d by gavage for 5 days.  One commercial preparation containing
19.0% LAS was also given, at a dose of 800, 1600, or 3200 mg/kg bw, and
another containing 17.1% LAS at a dose of 1000, 2000, or 4000 mg/kg bw
once only by gavage.

M ICR:JCL Mouse

Purity: Not Reported	There was no significant difference between any of
the groups given LAS and the negative control group in the incidence of
chromosomal aberrations

870.5385

Mammalian bone marrow chomosomal aberration test	MRID 43498428

J. Hope (1977) Absence of Chromosome Damage in the Bone Marrow of Rats
Fed Detergent Actives for 90 Days.  Mutation Research, 56: 47-50.

Acceptable

Guideline	SDDBS was administered in the diet for 90 days at 0, 280, and
565 mg/kg bw/d

Colworth/Wistar Weanling Rat (6/sex/dose)

Purity: Not Reported	All test preparations were negative for increased
chromosomal damage over controls.

870.5385

Mammalian bone marrow chomosomal aberration test	Masabuchi et al. (1976)
Cytogenetic Studies and Dominant Lethal Tests with Long Term
Administration of Butylated Hydroxytoluene (BHT) and LAS in Mice and
Rats, Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 27(2): 100-104.
(HERA)

Open Literature	LAS was administered in the diet for 9 months at a dose
of 0.9% in rats (450 mg/kg bw/d) and in mice (1170 mg/kg bw/d)

Male Rat and Male Mouse

Purity: Not Reported	There were no significant differences in the
incidences of chromosomal aberrations between the experimental and
control groups

870.5395

Mammalian erthrocyte micronucleus test	Kishi et al. (1984) Effects of
Surfactants on Bone Marrow Cells, Bull. Kanagawa Public Health Lab. 14:
57-58.  (HERA)

Open Literature	LAS was administered as a single intraperitoneal
injection at a dose of 100 mg/kg bw

3 M ddY Mice

Purity: Not Reported	There were no differences in the incidences of
polychromatic erythrocytes with micronuclei in the bone marrow cells
between the treated group and the control group

870.5395

Mammalian erthrocyte micronucleus test	Koizumi et al. (1985)
Implantation Disturbance Studies with LAS in Mice, Arch. Environ.
Contam. Toxicol. 14: 73-81.  (HERA)

Open Literature	LAS were administered as a single oral dose of 2 mg to
pregnant mice on day 3 of gestation.  On day 17 of gestation, each
animal received a subcutaneous dose of 1, 2, or 10 mg and were killed 24
h later.

Pregnant ICR Mice

Purity: Not Reported	There was no difference among treated groups in the
incidence of polychromatic erythrocytes with micronuclei in maternal
bone marrow or fetal liver or blood.  No mutagenetic effect was found in
any of the groups.

870.5450

Rodent dominant lethal assay	Masubuchi MA et al. (1976) Cytogenetic
Studies and Dominant Lethal Tests with Long Term Administration of
Butylated Hydroxytoluene (BHT) and Linear Alkylbenzene Sulfonate (LAS)
in Mice and Rats.  Ann Rep Tokyo Metrop Res Lab Public Heath, 27(2):
100-104.

(HERA)

Open Literature	A diet containing 0.6% LAS at 300 mg/kg bw/d was
administered to mice for 9 months. Each of the male mice was then mated
with two female mice that had not been given LAS, and 11 of the 14
females became pregnant.  The pregnant mice were laparotomized on day 13
of gestation

7 M ICR:JCL Mice

Purity: Not Reported	There were no significant differences in fertility,
mortality of ova and embryos, the number of surviving fetuses, or the
index of dominant lethal induction (Roehrborn) between the experimental
and control groups.

Metabolism

870.7485 General Metabolism	MRID 43498410

Creswell et al. (1978) Toxicology Studies of Linear Alkylbenzene
Sulphonate (LAS) in Rhesus Monkeys II.  The Disposition of C14-LAS After
Oral or Subcutaneous Administration.  Toxicology, 11: 5-17.

Acceptable

Guideline	Single oral doses of C14-LAS (SDDBS; 25 ucuries) were
administered to each animal, following 2-3 weeks between dose levels, at
levels of 30, 150, and 300 mg/kg.  Following 2-3 weeks after the last
single oral dose, each monkey received 7 consecutive daily oral doses of
30 mg/kg/d of C14-LAS.

2 M/2 F Rhesus Monkeys

Purity: Not Reported	After single 30 mg/kg doses the radioactivity was
rapidly excreted, mostly during the first 24 hours.  Feces and urine
contained 23.1% and 71.2%, respectively, in the first 5 days after oral
dosing.  Plasma concentrations were comparable after the oral doses and
averaged 34, 41, and 36 u/ml, respectively.  Peak plasma concentrations
increased proportional to the dose and were 0.16, 0.72, 1.13 u/ml,
respectively.  In urine samples analyzed for metabolites, there was no
unchanged SDDBS and the 5 metabolites detected were polar, but were not
sulphate or glucuronide conjugates.

870.7485 General Metabolism	Lay JP, et al. (1983) Toxicol. Letters 17
(1-2): 187-192

Open Literature	(14)C-labeled sodium dodecylbenzenesulfonate was
administered daily in the diet at a concentration of 1.4 mg/kg for 5
weeks

M Rat

Purity: not reported	From a total uptake of 1.213 + or - 0.08 mg/animal
of DBS, 81.8% was excreted during the dosing period: 52.4% in feces and
29.4% in urine.  Low levels of (14)C-DBS-derived residues were detected
in all tissues analyzed on day 35 of the study.  Following 1 week on a
normal diet, only 7.8% of the nominally stored amount of (14)C was found
in the excreta.

870.7485 General Metabolism	Sunakawa et al. (1979) Yakuzaigaku 39 (2):
59-68

Open Literature	Sodium-para-dodecylbenzenesulfonate

Rat

Purity: Not Reported	Blood levels were max at 2 hr, negligible at 48 hr

Excretion rate of radioactive label was 99.4% after 48 hr

870.7485 General Metabolism	The Royal Society of Chemistry. (1981)
Foreign Compound Metabolism in Mammals. Volume 6: A Review of the
Literature Published during 1978 and 1979. London: The Royal Society of
Chemistry, p.354.

Open Literature	(35)S-labeled sodium dodecylbenzenesulfonate was
administered as a single oral dose

Rat

Purity: Not Reported	Rats excreted 64% and 24% of the dose in urine and
feces, respectively

870.7485 General Metabolism	The Royal Society of Chemistry. (1981)
Foreign Compound Metabolism in Mammals. Volume 6: A Review of the
Literature Published during 1978 and 1979. London: The Royal Society of
Chemistry, p.354.	Repeated doses of (14)C-labeled alkylbenzenesulfonate
were orally administered

Rhesus Monkey

Purity: Not Reported	Radioactivity did not accumulate in the tissues

870.7485 General Metabolism	MRID 43498431

W. Michael (1968) Metabolism of Linear Alkylate Sulfonate and Alkyl
Benzene Sulfonate. Toxicol. Appl. Pharmacol. 12: 473-485.

Acceptable

Guideline	LAS-S35 was administered orally to fasted rats at doses of
0.6, 1.2, 8, and 40 mg

Charles River CD M Rat

Purity: Not Reported	The rate and distribution of the excreted dose was
independent of concentration.

Similar levels of radioactivity were found in urine and feces and within
3 days, 85.2% - 96.6% of the label was recovered.

In the high dose rats, no detectable radioactivity was found in the
carcasses after 3 days.

Following methylation, one urinary metabolite was identified as
4-(4'-methylsulfophenyl) pentanoate.  LAS-S35 in the feces remained
unmetabolized.

Special Studies

870.3700a

Developmental Toxicity (rodent)	Koizumi et al. (1985) Implantation
Disturbance Studies with LAS in Mice, Arch. Environ. Contam. Toxicol.
14: 73-81.  (HERA)

Open Literature	LAS was administered as a single oral dose of 350 mg/kg
bw on day 3 of gestation

Pregnant ICR Mice

Purity: Not Reported	LAS was not detected in the uterus

Other	Inoue K, T Sunakawa. (1979)  Mutagenicity Tests of Surfactants,
Jpn. Fragr. J. 38: 67-75, (in Japanese),  See: IPCS, 1996.  (HERA)

Open Literature	LAS tested in a recombination assay at concentrations up
to 50 ug/plate

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Open Literature	The proliferation rate of the connective tissue was
examined by measuring the activity of proline hydroxylase.  The dorsal
neck skin of rats was coated with sodium laurylbenzenesulfonate for 4
days, and on the 5th day, the enzyme activity in the skin was measured.

Rat

Purity: Not Reported	The proline hydroxylase in the part of the skin
coated with the irritants showed clearly higher activity than normal
skin, although it was still lower than the injured skin region prepared
as a positive control.

Other	MRID 43498430 and 43498408            Kimura et al. (1982)
Mechanisms of Toxicities of Some Detergents Added to a Diet and the
Ameliorating Effects of Dietary Fiber in the Rat. J. Nutrit. Science and
 Science and Vitaminology, 28: 483-489.

Kimura et al. (1982) Toxicity for Detergent Feeding and Effect of the
Concurrent Feeding of Dietary Fiber in the Rat. Nutrition Reports
International, 26(2): 271-279.

Acceptable

Guideline	Ringer's bicarbonate (containing sodium lauryl benzene
sulfonate) at 0.5 ml/min was used to perfuse a 10 cm length of jejunal
segment for 150 minutes; equilibrated for 30 minutes and then the
perfusates were collected in 30 minute aliqouts for 120 minutes

M Wistar Rat

Purity: 0.5%	Alkaline phosphatase was released by an increase of 15-fold
in comparison to Ringer's alone (controls without added sodium lauryl
benzene sulfonate) and 3-7 times greater than other surfactants tested
in Ringer's.  The authors conclude that SDDBS has an exfoliative effect
on the intestinal brush border

Other	Oba et al. (1968) Biochemical Studies of n-alpha-olefin
sulfonates: (II) Acute Toxicity, Skin and Eye Irritation, and Some Other
Physiological Properties.  J Jpn Oil Chem Soc, 17 (11): 628-634.  (EHC
169)

Open Literature	Solutions of various concentrations of LAS were mixed
with red blood cells from rabbits at room temperature for 3 hours

Rabbit Red Blood Cell

Purity: Not Reported	The 50% haemolytic concentration of LAS was 9
mg/litre

Other	Samejima Y (1991) Effects of Synthetic Surfactants and Natural
Soap on the Development of Mouse Embryos In Vitro and the Fertilizing
Capacity of Mouse and Human Sperm.  J Osaka Univ Med Sch, 3 (12):
675-682.  (EHC 169)

Open Literature	Eggs were fertilized in vitro and incubated in culture
medium containing LAS at concentrations between 0.015 and 0.03%.

F B6C3F1 Mouse Egg

Purity: Not Reported	Concentrations of LAS less than 0.025%: Eggs
exposed for 1 hr, washed, and then cultured for 5 days developed
normally to the blastocyst stage

Concentrations of LAS higher than 0.03%:  The eggs did not develop
beyond the one-cell stage

With continuous exposure to LAS for five days, a concentration of 0.01%
slightly impaired development to the blastocyst stage, and 0.025%
prevented development to the one-cell stage

Other	Takahashi et al. (1974) Inhibition of Thrombin by Linear
Alkylbenzene Sulfonate (LAS).  Ann Rep Tokyo Metrop Res Lab Public
Health, 25: 637-645.  (HERA)

Open Literature	Purified LAS at various concentrations were added to 10
ul of plasma from rats and prothrombin time was determined

M Rat

Purity: Not Reported	Prothrombin time was prolonged; the 50% inhibitory
concentration was about 0.6 mmol/litre.  When LAS at various
concentrations were added to a mixture of 1% fibrinogen and thrombin,
the time of formation of a mass of fibrin was prolonged by inhibition of
thrombin activity.  The 50% inhibitory concentration was about 0.05
mmol/litre.

Other	Yanagisawa et al. (1964) Biochemical Studies of Dodecylbenzene
Sulfonates; Differences Between Soft and Hard Detergents.  Jpn. J Public
Health, 11(13): 859-864.  (EHC 169)

Open Literature	The haemolytic action of LAS was investigated by mixing
red blood cells from rabbits with solutions of LAS at concentrations of
1-1000 mg/litre at 38 C for 30 min

Rabbit Red Blood Cell

Purity: Not Reported	Haemolysis occurred at concentrations >= 5
mg/litre.

  TC \l3 "9.1.2	Subchronic, Chronic and Other Toxicity Tables

	1 PAD = Population Adjusted Dose = Chronic RfD

						  FQPA Safety Factor

 A review of those products listed as containing ingredients
Benzenesulfonic acid, dodecyl- (CAS Reg. No. 27176-87-0); Sodium
dodecylbenzenesulfonate (CAS Reg. No. 25155-30-0); and Benzenesulfonic
acid, C10-16-alkyl derivs (CAS Reg. No.68584-22-5) was conducted.  The
results of that review indicate that the linear alkylbenzenesulfonates
are primarily used in low concentrations (typically less than 5% w/w) in
herbicide products that  typically are applied in a preemergent or early
post-emergent fashion.

Page   PAGE  1  of   NUMPAGES  61

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UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

			OFFICE OF THE SECRETARY

		WASHINGTON, D.C.

		Issued by the Department of Transportation on September 20, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-2005-22468

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  VOLGA-DNEPR J.S. CARGO AIRLINE (“Volga-Dnepr”)
  Date Filed:  September 13, 2005

Relief requested:  Exemption from 49 USC § 40109(g) to permit the
applicant to operate one, one-way cargo charter flight, using its
AN-124-100 aircraft, carrying outsized cargo on behalf of Lockheed
Martin Space Systems (LMSS), during the period September 21, 2005,
through September 27, 2005.  The applicant states that the flight would
operate from North Island Naval Air Station, California, to Denver,
Colorado.  The applicant further states that the flight would carry a
Centaur III Launch Vehicle Upper Stage Tank.  The applicant asserts that
LMSS needs the subject lift to meet an aggressive final assembly
schedule associated with mission integration and launch; that the cargo
is too large for transportation on U.S.-carrier aircraft; and that
surface transportation is not feasible because of the delicate nature of
the cargo.

Applicant representative:  Glenn P. Wicks,<PHONE_NUMBER>      		   DOT
analyst:  Robert J. Finamore,<PHONE_NUMBER>

Responsive pleadings:  Volga-Dnepr served its application on those U.S.
carriers operating large all-cargo aircraft.  Each carrier indicated
that it did not have aircraft available to conduct the proposed
operations and that it had no comment or did not oppose grant of the
requested authority.

Statutory Standards:  Under 49 USC § 40109(g), we may authorize a
foreign air carrier to carry commercial traffic between U.S. points
(i.e., cabotage traffic) under limited circumstances.  Specifically, we
must find that the authority is required in the public interest; that
because of an emergency created by unusual circumstances not arising in
the normal course of business the traffic cannot be accommodated by U.S.
carriers holding certificates under 49 USC § 41102; that all possible
efforts have been made to place the traffic on U.S. carriers; and that
the transportation is necessary to avoid unreasonable hardship to the
traffic involved (an additional required finding, concerning emergency
transportation during labor disputes, was not relevant here).

DISPOSITION

Action: Approved
                                                          Action date:
September 20, 2005

Effective dates of authority granted:  September 21, 2005 through
September 27, 2005

Basis for approval:  We are granting Volga-Dnepr’s request to operate
the proposed one-way flight (described above), on behalf of LMSS, from
September 21, 2005 through September 27, 2005.  We found that its
request met all the relevant criteria of 49 USC § 40109(g) for the
grant of an exemption of this type, and that the grant was required in
the public interest.  Specifically, we were persuaded that the need to
move the cargo to meet an extremely aggressive final assembly schedule
associated with mission integration and launch; the fact that the cargo
could not be transported by surface transportation because of its
delicate nature; and the unique, outsized nature of the cargo,
constituted an emergency not arising in the normal course of business.
Moreover, based on the representations of the U.S. carriers, we
concluded that no U.S. carrier had aircraft available that could be used
to conduct the operation at issue here.  We also found that grant of
this authority would prevent unreasonable hardship to LMSS.  Finally, we
found that the applicant was qualified to perform its proposed
operation.

Except to the extent exempted/waived, this authority is subject to our
standard exemption conditions (attached) and to the condition that the
applicant must comply with an FAA-approved flight routing for the
authorized operation.

Action taken by:        				Karan K. Bhatia

Assistant Secretary for Aviation

and International Affairs

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                       		       ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

05/2004


[Federal Register: September 22, 2008 (Volume 73, Number 184)]
[Notices]
[Page 54646-54648]
[DOCID:fr22se08-92]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58536; File No. 4-566]

Program for Allocation of Regulatory Responsibilities Pursuant to
Rule 17d-2; Order Approving and Declaring Effective a Plan for the
Allocation of Regulatory Responsibilities Among the American Stock
Exchange LLC, Boston Stock Exchange, Inc., CBOE Stock Exchange, LLC,
Chicago Stock Exchange, Inc., Financial Industry Regulatory Authority,
Inc., International Securities Exchange, LLC, The NASDAQ Stock Market
LLC, National Stock Exchange, Inc., New York Stock Exchange, LLC, NYSE
Arca Inc., NYSE Regulation, Inc., and Philadelphia Stock Exchange, Inc.

September 12, 2008.
    On August 12, 2008, the American Stock Exchange LLC (``Amex''),
Boston Stock Exchange, Inc. (``BSE''), CBOE Stock Exchange, LLC
(``CBOE''), Chicago Stock Exchange, Inc. (``CHX''), Financial Industry
Regulatory Authority, Inc. (``FINRA''), International Securities
Exchange, LLC (``ISE''), The NASDAQ Stock Market, LLC (``NASDAQ''),
National Stock Exchange, Inc. (``NSX''), New York Stock Exchange LLC
(``NYSE''), NYSE Arca Inc. (``NYSE Arca''), NYSE Regulation, Inc.
(acting under authority delegated to it by NYSE) (``NYSE Regulation''),
and Philadelphia Stock Exchange, Inc. (``Phlx'') (collectively,
``Participating Organizations'' or ``Parties'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 17(d) of the Securities Exchange Act of 1934 (``Act''),\1\ and
Rule 17d-2 thereunder,\2\ a proposed plan for the allocation of
regulatory responsibilities (``Plan''). The Plan was published for
comment on August 18, 2008.\3\ The Commission received no comments on
the Plan. This order approves and declares effective the Plan.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78q(d).
    \2\ 17 CFR 240.17d-2.
    \3\ See Securities Exchange Act Release No. 58350 (August 13,
2008), 73 FR 48248 (File No. 4-566) (``Notice'').
---------------------------------------------------------------------------

I. Introduction

    Section 19(g)(1) of the Act,\4\ among other things, requires every
self-regulatory organization (``SRO'') registered as either a national
securities exchange or national securities association to examine for,
and enforce compliance by, its members and persons associated with its
members with the Act, the rules and regulations thereunder, and the
SRO's own rules, unless the SRO is relieved of this responsibility
pursuant to Section 17(d) \5\ or Section 19(g)(2) \6\ of the Act.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(g)(1).
    \5\ 15 U.S.C. 78q(d).
    \6\ 15 U.S.C. 78s(g)(2).
---------------------------------------------------------------------------

    Section 17(d)(1) of the Act \7\ was intended, in part, to eliminate
unnecessary multiple examinations and regulatory duplication for those
broker-dealers that maintain memberships in more than one SRO (``common
members'').\8\ With respect to a common member, Section 17(d)(1)
authorizes the Commission, by rule or order, to relieve an SRO of the
responsibility to receive regulatory reports, to examine for and
enforce compliance with applicable statutes, rules, and regulations, or
to

perform other specified regulatory functions.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78q(d)(1).
    \8\ See Securities Act Amendments of 1975, Report of the Senate
Committee on Banking, Housing, and Urban Affairs to Accompany S.
249, S. Rep. No. 94-75, 94th Cong., 1st Session 32 (1975).
---------------------------------------------------------------------------

    To implement Section 17(d)(1), the Commission adopted two rules:
Rule 17d-1 and Rule 17d-2 under the Act.\9\ Rule 17d-1 authorizes the
Commission to name a single SRO as the designated examining authority
(``DEA'') to examine common members for compliance with the financial
responsibility requirements imposed by the Act, or by Commission or SRO
rules.\10\ When an SRO has been named as a common member's DEA, all
other SROs to which the common member belongs are relieved of the
responsibility to examine the firm for compliance with the applicable
financial responsibility rules. On its face, Rule 17d-1 deals only with
an SRO's obligations to enforce broker dealers' compliance with
financial responsibility requirements. Rule 17d-1 does not relieve an
SRO from its obligation to examine a common member for compliance with
its own rules and provisions of the federal securities laws governing
matters other than financial responsibility, including sales practices
and trading activities and practices.
---------------------------------------------------------------------------

    \9\ 17 CFR 240.17d-1 and 17 CFR 240.17d-2, respectively.
    \10\ See Securities Exchange Act Release No. 12352 (April 20,
1976), 41 FR 18808 (May 7, 1976).
---------------------------------------------------------------------------

    To address regulatory duplication in these and other areas, the
Commission adopted Rule 17d-2 under the Act.\11\ Rule 17d-2 permits
SROs to propose joint plans for the allocation of regulatory
responsibilities with respect to their common members. Under paragraph
(c) of Rule 17d-2, the Commission may declare such a plan effective if,
after providing for notice and comment, it determines that the plan is
necessary or appropriate in the public interest and for the protection
of investors, to foster cooperation and coordination among the SROs, to
remove impediments to, and foster the development of, a national market
system and a national clearance and settlement system, and is in
conformity with the factors set forth in Section 17(d) of the Act.
Commission approval of a plan filed pursuant to Rule 17d-2 relieves an
SRO of those regulatory responsibilities allocated by the plan to
another SRO.
---------------------------------------------------------------------------

    \11\ See Securities Exchange Act Release No. 12935 (October 28,
1976), 41 FR 49091 (November 8, 1976).
---------------------------------------------------------------------------

II. The Plan

    The proposed Plan is designed to eliminate regulatory duplication
by allocating regulatory responsibility over Common NYSE Members \12\
or Common FINRA Members,\13\ as applicable, (collectively, ``Common
Members'') for the surveillance, investigation, and enforcement of
common insider trading rules (``Common Rules'').\14\ The Plan assigns
regulatory responsibility over Common NYSE Members to NYSE Regulation
for surveillance, investigation, and enforcement of insider trading by
broker-dealers, and their associated persons, with respect to NYSE-
listed stocks and NYSE Arca-listed stocks, irrespective of the
marketplace(s) maintained by the Participating Organizations on which
the relevant trading may occur. The Plan assigns regulatory
responsibility over Common FINRA Members to FINRA for surveillance,
investigation, and enforcement of insider trading by broker-dealers,
and their associated persons, with respect to NASDAQ-listed stocks and
Amex-listed stocks, as well as any CHX solely-listed stock,
irrespective of the marketplace(s) maintained by the Participating
Organizations on which the relevant trading may occur. The full text of
the Plan and Exhibits A, B, and C thereto can be found in the Notice.
---------------------------------------------------------------------------

    \12\ Common NYSE Members include members of the NYSE and at
least one of the Participating Organizations.
    \13\ Common FINRA Members are members of FINRA and at least one
of the Participating Organizations.
    \14\ Common Rules are defined as: (i) Federal securities laws
and rules promulgated by the Commission pertaining to insider
trading, and (ii) the rules of the Participating Organizations that
are related to insider trading. See Exhibit A to the Plan.
---------------------------------------------------------------------------

    In addition to the Plan, the Participating Organizations have
entered into two regulatory services agreements that address
investigation and enforcement in situations that involve trading in
equity securities by non-Common Members, as Rule 17d-2 covers only
situations involving Common Members. The first agreement is between
NYSE Regulation (acting as the regulatory services provider), FINRA,
and each of the exchanges (``NYSE Regulation Agreement''). The second
agreement is between FINRA (acting as the regulatory services
provider), NYSE Regulation, and each of the exchanges (``FINRA
Agreement''). The agreements provide for the investigation and
enforcement of suspected insider trading against broker-dealers and
their associated persons that (i) are not Common Members of NYSE in the
case of insider trading in NYSE-listed stocks and NYSE-Arca listed
stocks; or (ii) are not Common Members of FINRA in the case of insider
trading in NASDAQ-listed stocks, Amex-listed stocks, and any CHX
solely-listed stock.
    Under the agreements, NYSE Regulation and FINRA, respectively, will
provide to the exchanges ``Core Services'' related and limited to the
investigation and enforcement activities for non-Common Members where
these activities relate to insider trading of equity securities listed
on the NYSE or NYSE Arca in the case of the NYSE Regulation Agreement,
and to the insider trading of equity securities listed on the Nasdaq or
Amex, and any CHX solely-listed security in the case of the FINRA
Agreement. The Core Services provided under the agreements are rendered
(a) only upon completion of a surveillance review under the 17d-2 Plan,
and (b) at the request of the relevant exchange. Pursuant to the Plan,
NYSE Regulation and FINRA will conduct surveillance, investigation, and
enforcement for insider trading for Common NYSE Members and Common
FINRA Members, respectively. Surveillance for non-Common Members is
excluded from the Plan and remains the responsibility of the SROs in
which such non-Common Members maintain membership. However, due to the
nature of insider trading surveillance technology and processes, the
surveillance conducted by NYSE Regulation and FINRA will encompass non-
Common Members as the surveillance function does not differentiate
between Common and non-Common Members. Accordingly, the investigation
and enforcement services performed under the agreements will arise from
surveillance undertaken by NYSE Regulation and FINRA.

III. Discussion

    The Commission finds that the proposed Plan is consistent with the
factors set forth in Section 17(d) of the Act \15\ and Rule 17d-2
thereunder \16\ in that the proposed Plan is necessary or appropriate
in the public interest and for the protection of investors, fosters
cooperation and coordination among SROs, and removes impediments to and
fosters the development of the national market system. In particular,
the Commission believes that the proposed Plan should reduce
unnecessary regulatory duplication by allocating regulatory
responsibility for the surveillance, investigation, and enforcement of
Common Rules over Common NYSE Members, with respect to NYSE-listed
stocks and NYSE Arca-listed stocks, to NYSE and over Common FINRA
Members, with respect to NASDAQ-listed stocks, Amex-listed stocks, and
any CHX solely-listed stock,

to FINRA. Accordingly, the proposed Plan promotes efficiency by
consolidating these regulatory functions in a single SRO based on the
listing market for a stock, with regard to Common NYSE Members and
Common FINRA Members.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78q(d).
    \16\ 17 CFR 240.17d-2.
---------------------------------------------------------------------------

    In addition, the Commission notes that the Plan provides that the
costs for insider trading surveillance would be shared among the
Participating Organizations based on their relative trade volume,
subject to certain minimum payment amounts for smaller markets.
Modifications to the fees assessed the Participating Organizations
pursuant to the cost allocation methodologies established in the Plan
do not require an amendment to the Plan; however, any modifications to
the cost allocation methodologies would require approval by the
Commission. The Commission believes that the Plan provides a reasonable
method to allocate among the Parties expenses reasonably incurred by
the SRO having regulatory responsibilities under the Plan.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 240.17d-2(b).
---------------------------------------------------------------------------

    The Commission also notes that because under Rule 17d-2 regulatory
responsibility may be allocated from one SRO to another SRO only for
Common Members, the Participating Organizations have entered into two
regulatory services agreements with NYSE Regulation and FINRA,
respectively, to address investigation and enforcement of suspected
insider trading involving members who are neither Common NYSE Members
nor Common FINRA Members.\18\ The Commission is neither approving nor
disapproving the terms of the regulatory services agreements. However,
the Commission does note that under these regulatory services
agreements the ultimate responsibility and primary liability for self-
regulatory obligations would remain with each exchange and association,
rather than the SRO retained to perform such functions.
---------------------------------------------------------------------------

    \18\ Members only of the NYSE would be the responsibility of
NYSE; members only of FINRA would be the responsibility of FINRA.
---------------------------------------------------------------------------

IV. Conclusion

    This Order gives effect to the Plan filed with the Commission in
File No. 4-566. The Parties shall notify all members affected by the
Plan of their rights and obligations under the Plan.
    It is therefore ordered, pursuant to Section 17(d) of the Act,\19\
that the Plan in File No. 4-566 by and among Amex, BSE, CBOE, CHX,
FINRA, ISE, NASDAQ, NSX, NYSE, NYSE Arca, NYSE Regulation, and Phlx
filed pursuant to Rule 17d-2 is hereby approved and declared effective.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78q(d).
---------------------------------------------------------------------------

    It is further ordered that the Participating Organizations are
relieved of those regulatory responsibilities allocated to NYSE and
FINRA under the Plan in File No. 4-566.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(34).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-22013 Filed 9-19-08; 8:45 am]

BILLING CODE 8010-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		07-FEB-2008

Subject:	Novaluron.  Chronic Dietary Exposure and Risk Assessment for the Section 3 Registration on Sugarcane and Tomato (PP#7E7199).

PC Code:  124002.  DP#:  347657.  Decision#:  379033.

Reviewer:	George F. Kramer, Ph.D., Senior Chemist

Registration Action Branch 1 (RAB1)

Health Effects Division (HED) (7509P)

To:		Mary Clock-Rust, Risk Assessor

RAB1/HED (7509P)

Through:	Thurston Morton, Chemist

Sarah Winfield, Biologist

Dietary Exposure Science Advisory Council (DESAC)/HED (7509P)

and

P.V. Shah, Ph.D. Branch Senior Scientist

RAB1/HED (7509P)

Executive Summary

A chronic dietary exposure and risk assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID(, Version 2.03), which uses food consumption data from the USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analysis was performed to support a Section 3 request for use of novaluron on sugarcane and tomato.  The last dietary risk assessment for novaluron was conducted on 26-JUL-2006 (Memo, S. Levy; DP# 322553).

Chronic:  The current chronic dietary assessment is an update of the previous dietary assessment conducted in 2005 (i.e., average field trial residue values for the raw agricultural commodities (RACs) associated with this action and empirical processing factors for tomato purée and paste were added to the last dietary assessment).  Estimated drinking water concentrations (EDWCs), provided by the Environmental Fate and Effects Division (EFED), were included in this assessment as well.  In the last dietary assessment, the chronic analysis assumed 100% crop treated for all commodities; incorporated average field trial residues for some commodities; empirical processing factors for apple juice (translated to pear juice); and DEEM( (ver 7.81) default processing factors for the remaining processed commodities.  Furthermore, anticipated residues (ARs) were used for meat and milk commodities and recommended tolerances were used for poultry commodities.

For this dietary assessment, the resulting chronic food + water exposure estimates were not of concern to HED ((74% of the chronic population-adjusted dose (cPAD); children 1-2 years old were the most highly exposed population).  An acute dietary assessment was not conducted for novaluron because an endpoint of concern attributable to a single dose was not identified.  A cancer dietary assessment was not conducted because novaluron was classified as “not likely to be carcinogenic to humans.”

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population-adjusted dose (PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.  For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (20-AUG-1999).  The last dietary risk assessment for novaluron was conducted on 26-JUL-2006 (Memo, S. Levy; DP# 322553).

II.	Residue Information

Novaluron tolerances are published in 40 CFR§180.598.

Residues of Concern:  The residue of concern in crops and livestock, for purposes of tolerance enforcement and risk assessment, is novaluron per se.  The residues of concern in drinking water for purposes of risk assessment are novaluron, the chlorophenyl urea metabolite (1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]urea), and the chloroaniline metabolite (3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)aniline) (Memo, G. Kramer et al., 03-FEB-2004; DP# 297646) (see Table 1).

Table 1:  Novaluron Residues of Concern in Plants, Ruminants, and Drinking Water.

Matrix	Residues of Concern

	For Risk Assessment	For Tolerance Expression

Plants	Parent only	Parent only

Ruminant	Parent only	Parent only

Milk	Parent only	Parent only

Water	Parent, the chlorophenyl urea metabolite, and the chloroaniline metabolite	NA

Recommended Tolerances:  Based on the residue chemistry data submitted with the current petition, HED recommended for establishment of the tolerances listed in Table 2 (Memo, G. Kramer, 07-FEB-2008; D340137).  In addition, HED has recommended that the existing egg tolerance should be increased to 0.07 ppm (Memo, S. Levy, 31-JAN-2008; D340137).

Table 2:  HED-Recommended Tolerances for Novaluron.

Commodity

Recommended Tolerance (ppm)

Tomato

1.0

Sugarcane, cane

0.50

Eggs	0.07

Residues used in the Chronic Analysis (see Attachments 1 and 2):  In the last dietary assessment, the chronic analysis assumed 100% crop treated for all commodities; incorporated average field trial residues for some commodities; empirical processing factors for apple juice (translated to pear juice); and DEEM( (ver 7.81) default processing factors for the remaining processed commodities.  Furthermore, ARs were calculated for meat and milk commodities and recommended tolerances were used for poultry commodities.

The sugarcane commodities associated with the current petition were added at the average field trial residue value (0.125 ppm) to the last dietary assessment.  For tomatoes, an overall (small- & large-fruit varieties) average of the greenhouse trial residues (0.161 ppm) was used.  Empirical processing factors were used for tomato purée and paste.

Water Residues Used in the Analyses:  The drinking water values used in this dietary risk assessment were provided by the EFED (Memo, I. Maher, 11-FEB-2004; DP#285477).  Monitoring data are not available for novaluron or its degradates, chlorophenyl urea and chloroaniline, in surface water or ground water.  Concentrations in surface water and ground water were estimated using modeling.

Novaluron:  EFED used Tier 2 Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) modeling to estimate drinking water concentrations for surface water for novaluron per se.  The EDWC (1-in-10-year annual mean) for novaluron per se is 1.8 ppb.  For groundwater, the Screening Concentration in Ground Water (SCI-GROW) model was used to predict a groundwater concentration for novaluron.  The EDWC for novaluron per se is 0.0055 ppb in drinking water from shallow ground water sources.

Chlorophenyl urea and chloroaniline degradates:  A Tier I drinking water analysis was performed using the FQPA Index Reservoir Screening Tool (FIRST) model to obtain surface water estimates for the chlorophenyl urea and chloroaniline degradates.  For surface water, the annual average EDWC for chlorophenyl urea is 0.86 ppb and the annual average EDWC for chloroaniline is 2.6 ppb.  For ground water, the SCI-GROW model was used to predict groundwater concentrations.  The predicted ground water EDWC for chlorophenyl urea is 0.0045 ppb, and for chloroaniline the EDWC is 0.0090 ppb.

These EDWC values are meant to represent upper-bound estimates of the concentrations that might be found in surface water and groundwater based upon existing and proposed uses.  Of the three EDWC values, chronic estimates for the terminal metabolite, chloroaniline is the highest (100% conversion from parent to aniline was assumed).  This is consistent with the expected degradation pattern for novaluron.  Therefore, the EDWC value for chloroaniline (2.6 ppb) was used to assess chronic aggregate risk for this dietary assessment.  EFED has confirmed that this value is applicable to the current action (Memo, I. Maher, 13-DEC-2007; D340579).

III.	Program and Consumption Information

DEEM-FCID( Program and Consumption Information:  A novaluron chronic dietary exposure assessment was conducted using the DEEM-FCID( (ver. 2.03), which incorporates consumption data from USDA’s CSFII (1994-1996 and 1998).  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (i.e., apple pie) are linked to EPA-defined food commodities (i.e., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups:  the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (i.e., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form.  The resulting residue consumption estimate for each food/food form is summed with the residue consumption estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

IV.	Toxicological Information

The HED Hazard Identification Assessment Review Committee (HIARC) met on 16-DEC-2003 to determine endpoint selection for novaluron.  At this meeting, the HIARC also evaluated the potential for increased susceptibility of infants and children from exposure to novaluron as required by the FQPA of 1996 (TXR No.0052361, 04-FEB-2004).  Table 3 is a summary of the decisions made by the HIARC concerning dietary exposure assessment, and are still considered appropriate for the current risk assessment.

Table 3.  Summary of Toxicological Dose and Endpoints for Novaluron.

Exposure

Scenario

Dose Used in Risk Assessment, UF

Special FQPA SF* and Level of Concern for Risk Assessment

Study and Toxicological Effects

Acute Dietary

Not applicable

None

An endpoint of concern attributable to a single dose was not identified.  An acute RfD was not established.

Chronic Dietary

(All populations)

NOAEL= 1.1 mg/kg/day

UF = 100

Chronic RfD =

0.011 mg/kg/day

FQPA SF =  1X

cPAD =

chronic RfD

FQPA SF

= 0.011 mg/kg/day

Combined chronic toxicity/carcinogenicity feeding in rat

LOAEL = 30.6 mg/kg/day based on erythrocyte damage and turnover resulting in a regenerative anemia.

Cancer

Not likely to be carcinogenic to humans

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = lowest-observed-adverse-effect-level, PAD = population-adjusted dose, RfD = reference dose.

V.	Results/Discussion

As stated above, for a chronic assessment, HED is concerned when dietary risk exceeds 100% of the cPAD.  The chronic analysis was performed using DEEM-FCID( (ver. 2.03).  The DEEM-FCID( analysis estimates the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 4 are for the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years old.  The resulting food + water exposure estimates were not of concern to HED ((74% cPAD); children 1-2 years old were the most highly exposed population (see Attachment 3 for details).

Table 4:  Summary of Chronic Dietary Exposure and Risk for Novaluron.

Population Subgroup

cPAD (mg/kg/day)

Exposure (mg/kg/day)

%cPAD

General U.S. Population

0.011

0.002332

21

All Infants (< 1 year old)

0.003766

34

Children 1-2 years old

0.008146

74

Children 3-5 years old

0.006306

57

Children 6-12 years old

0.003837

35

Youth 13-19 years old

0.002033

18

Females 13-49 years old

0.001560

14

Adults 20-49 years old

0.001662

15

Adults 50+ years old

0.001486

13

VI.	Characterization of Inputs/Outputs

The chronic dietary assessment was refined through the use of empirical processing factors, some average field trial residues, and ARs for meat and milk commodities.  Despite this, HED concludes that the chronic estimates are conservative since they assumed average residues based on field trial data (maximum application rate; minimum pre-harvest interval (PHI); frozen immediately after harvest) and assumed 100% crop treated.  The current chronic analysis could be further refined through the following:  use of % crop treated data; preparation/cooking factors; and/or ARs for poultry commodities.

VII.	Conclusions

A chronic dietary risk assessment was conducted using the DEEM-FCID( (ver. 2.03) model.  The currently proposed commodities associated with this petition were added (sugarcane and tomatoes at the average field trial residue) to the last dietary assessment (which incorporated empirical processing factors, average field trial residues, and ARs for meat and milk commodities).  EDWC values, provided by EFED, were also added to this dietary assessment.  The resulting food + water exposure estimates were not of concern to HED ((74% cPAD); children 1-2 years old were the most highly exposed population.

An acute dietary assessment was not conducted because an endpoint of concern attributable to a single dose was not identified for novaluron.  A cancer dietary assessment was not conducted because novaluron was classified as “not likely to be carcinogenic to humans.”

VIII.	List of Attachments

Attachment 1:	AR Table.

Attachment 2:	DEEM-FCID( Chronic Residue File

Attachment 3:	DEEM-FCID( Chronic Exposure Estimates

cc with all attachments:  Daniel Rosenblatt (PM Team 05; RD)

RDI: DESAC (28-JAN-2008)

G.F. Kramer:S10781:PY-S:(703)305-5079:7509P:RAB1

Attachment 1:  Processing Factors and Residue Estimates from Previous Novaluron Dietary Assessment (Memo, G. Kramer, 22-MAR-2004; DP#298783) Updated to Include Tomato and Sugarcane Commodities.

crop

commodity

processing

factor1

residue (ppm)1

comment

meat2	meat	1	0.112	AR

dried beef meat	dried meat	1.92	0.112	AR; DEEM (ver 7.78) default proc. fact.

fat2	fat	1	2.43	AR

liver2	liver	1	0.190	AR

kidney2	kidney	1	0.183	AR

milk	Milk, fat	1	2.82	AR, calculated assuming residues partition into fat

	Milk, nonfat solids	1	0.113	AR for whole milk, used to account for low residues observed in skim milk

	Milk, water	1	0	All residues assumed to be associated with fat and solids.

	Milk, sugar	1	0	All residues assumed to be associated with fat and solids.

pork meat	meat	1	0.0024	AR

pork skin	skin	1	0.053	AR (fat)

pork fat	fat	1	0.053	AR

pork liver	liver	1	0.0040	AR

pork kidney	kidney	1	0.0041	AR

cotton	cottonseed oil	1	0.60	Tolerance for RAC adequate to cover residues in processed commodity

tuberous and corm vegetables	All	1	0.025	½ LOQ residue; DEEM (ver 7.78) default proc. factor of 6.5 used for potato, dry

pome fruit – apple, crabapple	RAC, sauce	1	0.578	average field trial residue

	dried	8	0.578	average field trial residue; DEEM (ver 7.78) default proc. fact.

	juice	0.10	0.578	average field trial residue; empirical proc. fact.

pome fruit – pear + other pome fruit	RAC	1	0.833	average field trial residue

	dried	6.25	0.833	average field trial residue; DEEM (ver 7.78) default proc. fact.

	juice	0.10	0.833	average field trial residue; empirical apple proc. fact.

Sugarcane	sugar	1	0.125	average field trial residue

	molasses	1	0.125	average field trial residue

tomato	RAC	1	0.161	overall (small- & large-fruit varieties) average of the greenhouse trial residue.

	dried	14.3	0.161	overall average of the greenhouse trial residue; DEEM (ver 7.78) default proc. fact.

	juice	1.5	0.161	overall average of the greenhouse trial residue; DEEM (ver 7.78) default proc. fact.

	purée	0.7	0.161	overall average of the greenhouse trial residue; empirical proc. fact.

	paste	1.1	0.161	overall average of the greenhouse trial residue; empirical proc. fact.

1 see 285474, G. Kramer ,22-MAR-2004

2cattle, goat, horse, and sheep

3apple and pear residues were translated to the remaining pome fruit crops using HED SOP 2000.1

Attachment 2:  DEEM-FCID( Chronic Residue File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for NOVALURON                          1994-98 data

Residue file: C:\Documents and Settings\gkramer\GK\$Novaluron\124002c.R98

                                                               Adjust. #2 used

Analysis Date 01-18-2008             Residue file dated: 01-18-2008/10:39:33/8

Reference dose (RfD) = 0.011 mg/kg bw/day

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

11000070 11   Apple, fruit with peel             0.578000   1.000      1.000

11000080 11   Apple, peeled fruit                0.578000   1.000      1.000

11000081 11   Apple, peeled fruit-babyfood       0.578000   1.000      1.000

11000090 11   Apple, dried                       0.578000   8.000      1.000

11000091 11   Apple, dried-babyfood              0.578000   8.000      1.000

11000100 11   Apple, juice                       0.578000   0.100      1.000

11000101 11   Apple, juice-babyfood              0.578000   0.100      1.000

11000110 11   Apple, sauce                       0.578000   1.000      1.000

11000111 11   Apple, sauce-babyfood              0.578000   1.000      1.000

01030150 1CD  Arrowroot, flour                   0.025000   1.000      1.000

01030151 1CD  Arrowroot, flour-babyfood          0.025000   1.000      1.000

01030170 1CD  Artichoke, Jerusalem               0.025000   1.000      1.000

21000440 M    Beef, meat                         0.112000   1.000      1.000

21000441 M    Beef, meat-babyfood                0.112000   1.000      1.000

21000450 M    Beef, meat, dried                  0.112000   1.920      1.000

21000460 M    Beef, meat byproducts              0.190000   1.000      1.000

21000461 M    Beef, meat byproducts-babyfood     0.190000   1.000      1.000

21000470 M    Beef, fat                          2.430000   1.000      1.000

21000471 M    Beef,fat-babyfood                  2.430000   1.000      1.000

21000480 M    Beef, kidney                       0.183000   1.000      1.000

21000490 M    Beef, liver                        0.190000   1.000      1.000

21000491 M    Beef, liver-babyfood               0.190000   1.000      1.000

05010610 5A   Broccoli                           0.500000   1.000      1.000

05010611 5A   Broccoli-babyfood                  0.500000   1.000      1.000

05010620 5A   Broccoli, Chinese                  0.500000   1.000      1.000

05010640 5A   Brussels sprouts                   0.500000   1.000      1.000

05010690 5A   Cabbage                            0.500000   1.000      1.000

05010710 5A   Cabbage, Chinese, napa             0.500000   1.000      1.000

05010720 5A   Cabbage, Chinese, mustard          0.500000   1.000      1.000

01030820 1CD  Cassava                            0.025000   1.000      1.000

01030821 1CD  Cassava-babyfood                   0.025000   1.000      1.000

05010830 5A   Cauliflower                        0.500000   1.000      1.000

40000930 P    Chicken, meat                      0.030000   1.000      1.000

40000931 P    Chicken, meat-babyfood             0.030000   1.000      1.000

40000940 P    Chicken, liver                     0.040000   1.000      1.000

40000950 P    Chicken, meat byproducts           0.040000   1.000      1.000

40000951 P    Chicken, meat byproducts-babyfoo   0.040000   1.000      1.000

40000960 P    Chicken, fat                       0.400000   1.000      1.000

40000961 P    Chicken, fat-babyfood              0.400000   1.000      1.000

40000970 P    Chicken, skin                      0.400000   1.000      1.000

40000971 P    Chicken, skin-babyfood             0.400000   1.000      1.000

95001280 O    Cottonseed, oil                    0.600000   1.000      1.000

95001281 O    Cottonseed, oil-babyfood           0.600000   1.000      1.000

11001290 11   Crabapple                          0.578000   1.000      1.000

01031390 1CD  Dasheen, corm                      0.025000   1.000      1.000

70001450 P    Egg, whole                         0.070000   1.000      1.000

70001451 P    Egg, whole-babyfood                0.070000   1.000      1.000

70001460 P    Egg, white                         0.070000   1.000      1.000

70001461 P    Egg, white (solids)-babyfood       0.070000   1.000      1.000

70001470 P    Egg, yolk                          0.070000   1.000      1.000

70001471 P    Egg, yolk-babyfood                 0.070000   1.000      1.000

01031660 1CD  Ginger                             0.025000   1.000      1.000

01031661 1CD  Ginger-babyfood                    0.025000   1.000      1.000

01031670 1CD  Ginger, dried                      0.025000   1.000      1.000

23001690 M    Goat, meat                         0.112000   1.000      1.000

23001700 M    Goat, meat byproducts              0.190000   1.000      1.000

23001710 M    Goat, fat                          2.430000   1.000      1.000

23001720 M    Goat, kidney                       0.183000   1.000      1.000

23001730 M    Goat, liver                        0.190000   1.000      1.000

24001890 M    Horse, meat                        0.112000   1.000      1.000

05011960 5A   Kohlrabi                           0.500000   1.000      1.000

11002100 11   Loquat                             0.833000   1.000      1.000

27002220 D    Milk, fat                          2.820000   1.000      1.000

27002221 D    Milk, fat - baby food/infant for   2.820000   1.000      1.000

27012230 D    Milk, nonfat solids                0.113000   1.000      1.000

27012231 D    Milk, nonfat solids-baby food/in   0.113000   1.000      1.000

11002660 11   Pear                               0.833000   1.000      1.000

11002661 11   Pear-babyfood                      0.833000   1.000      1.000

11002670 11   Pear, dried                        0.833000   6.250      1.000

11002680 11   Pear, juice                        0.833000   0.100      1.000

11002681 11   Pear, juice-babyfood               0.833000   0.100      1.000

25002900 M    Pork, meat                         0.002400   1.000      1.000

25002901 M    Pork, meat-babyfood                0.002400   1.000      1.000

25002910 M    Pork, skin                         0.053000   1.000      1.000

25002920 M    Pork, meat byproducts              0.004100   1.000      1.000

25002921 M    Pork, meat byproducts-babyfood     0.004100   1.000      1.000

25002930 M    Pork, fat                          0.053000   1.000      1.000

25002931 M    Pork, fat-babyfood                 0.053000   1.000      1.000

25002940 M    Pork, kidney                       0.004100   1.000      1.000

25002950 M    Pork, liver                        0.004000   1.000      1.000

01032960 1C   Potato, chips                      0.025000   1.000      1.000

01032970 1C   Potato, dry (granules/ flakes)     0.025000   6.500      1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.025000   6.500      1.000

01032980 1C   Potato, flour                      0.025000   1.000      1.000

01032981 1C   Potato, flour-babyfood             0.025000   1.000      1.000

01032990 1C   Potato, tuber, w/peel              0.025000   1.000      1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.025000   1.000      1.000

01033000 1C   Potato, tuber, w/o peel            0.025000   1.000      1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.025000   1.000      1.000

60003010 P    Poultry, other, meat               0.030000   1.000      1.000

60003020 P    Poultry, other, liver              0.040000   1.000      1.000

60003030 P    Poultry, other, meat byproducts    0.040000   1.000      1.000

60003040 P    Poultry, other, fat                0.400000   1.000      1.000

60003050 P    Poultry, other, skin               0.400000   1.000      1.000

11003100 11   Quince                             0.833000   1.000      1.000

26003390 M    Sheep, meat                        0.112000   1.000      1.000

26003391 M    Sheep, meat-babyfood               0.112000   1.000      1.000

26003400 M    Sheep, meat byproducts             0.190000   1.000      1.000

26003410 M    Sheep, fat                         2.430000   1.000      1.000

26003411 M    Sheep, fat-babyfood                2.430000   1.000      1.000

26003420 M    Sheep, kidney                      0.183000   1.000      1.000

26003430 M    Sheep, liver                       0.190000   1.000      1.000

95003620 O    Sugarcane, sugar                   0.125000   1.000      1.000

95003621 O    Sugarcane, sugar-babyfood          0.125000   1.000      1.000

95003630 O    Sugarcane, molasses                0.125000   1.000      1.000

95003631 O    Sugarcane, molasses-babyfood       0.125000   1.000      1.000

01033660 1CD  Sweet potato                       0.025000   1.000      1.000

01033661 1CD  Sweet potato-babyfood              0.025000   1.000      1.000

01033710 1CD  Tanier, corm                       0.025000   1.000      1.000

08003750 8    Tomato                             0.161000   1.000      1.000

08003751 8    Tomato-babyfood                    0.161000   1.000      1.000

08003760 8    Tomato, paste                      0.161000   1.100      1.000

08003761 8    Tomato, paste-babyfood             0.161000   1.100      1.000

08003770 8    Tomato, puree                      0.161000   0.700      1.000

08003771 8    Tomato, puree-babyfood             0.161000   0.700      1.000

08003780 8    Tomato, dried                      0.161000  14.300      1.000

08003781 8    Tomato, dried-babyfood             0.161000  14.300      1.000

08003790 8    Tomato, juice                      0.161000   1.500      1.000

01033870 1CD  Turmeric                           0.025000   1.000      1.000

86010000 O    Water, direct, all sources         0.002610   1.000      1.000

86020000 O    Water, indirect, all sources       0.002610   1.000      1.000

01034060 1CD  Yam, true                          0.025000   1.000      1.000

01034070 1CD  Yam bean                           0.025000   1.000      1.000

Attachment 3:  DEEM-FCID( Chronic Exposure Estimates

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for NOVALURON                        (1994-98 data)

Residue file name: C:\Documents and Settings\gkramer\GK\$Novaluron\124002c.R98

                                                     Adjustment factor #2 used.

Analysis Date 01-31-2008/09:50:25     Residue file dated: 01-31-2008/09:49:52/8

Reference dose (RfD, Chronic) = .011 mg/kg bw/day

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.002332                21.2%

U.S. Population (spring season)             0.002327                21.2%

U.S. Population (summer season)             0.002244                20.4%

U.S. Population (autumn season)             0.002439                22.2%

U.S. Population (winter season)             0.002312                21.0%

Northeast region                            0.002459                22.4%

Midwest region                              0.002395                21.8%

Southern region                             0.002150                19.5%

Western region                              0.002439                22.2%

Hispanics                                   0.002679                24.4%

Non-hispanic whites                         0.002254                20.5%

Non-hispanic blacks                         0.002409                21.9%

Non-hisp/non-white/non-black                0.002552                23.2%

All infants (< 1 year)                      0.003766                34.2%

Nursing infants                             0.001992                18.1%

Non-nursing infants                         0.004439                40.4%

Children 1-6  yrs                           0.006725                61.1%

Children 7-12 yrs                           0.003601                32.7%

Females 13-19 (not preg or nursing)         0.001772                16.1%

Females 20+ (not preg or nursing)           0.001462                13.3%

Females 13-50 yrs                           0.001742                15.8%

Females 13+ (preg/not nursing)              0.002136                19.4%

Females 13+ (nursing)                       0.002035                18.5%

Males 13-19 yrs                             0.002272                20.7%

Males 20+ yrs                               0.001728                15.7%

Seniors 55+                                 0.001484                13.5%

Children 1-2 yrs                            0.008146                74.1%

Children 3-5 yrs                            0.006306                57.3%

Children 6-12 yrs                           0.003837                34.9%

Youth 13-19 yrs                             0.002033                18.5%

Adults 20-49 yrs                            0.001662                15.1%

Adults 50+ yrs                              0.001486                13.5%

Females 13-49 yrs                           0.001560                14.2%

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

Novaluron	Dietary Exposure & Risk Assessment		DP#: 347657

PC Code:  124002

 PAGE

Page   PAGE  1  of   NUMPAGES  11


[Federal Register: October 13, 2009 (Volume 74, Number 196)]
[Notices]
[Page 52520-52521]
[DOCID:fr13oc09-104]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, October
15, 2009 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
October 15, 2009 will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Other matters relating to enforcement proceedings;
    An adjudicatory matter; and
    A post argument discussion.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:

    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: October 8, 2009.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-24702 Filed 10-8-09; 4:15 pm]

BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Pages 67416-67417]
[FR Doc No: 2018-28315]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Form ID. SEC File No. 270-291, OMB Control No. 3235-0328

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form ID (OMB Control No. 3235-0328; SEC File No. 270-291) is used
by companies and other entities to apply for identification numbers and
access codes used in conjunction with the EDGAR electronic filing
system. The information provided on Form ID is an essential part of the
security of the EDGAR system. Form ID must be filed every time a
registrant or other person obtains or changes an identification number.
Form ID is filed by all persons that are required to file information
electronically on EDGAR, including but not limited to, individuals,
companies, other for-profit organizations, or governmental entities. We
estimate that approximately 46,842 filers file Form ID annually and
that it takes approximately 0.15 hours per response to prepare for a
total of 7,027 annual burden hours.
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to Charles Riddle, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Candace Kenner, 100 F Street NE, Washington, DC 20549 or send an
email to<EMAIL_ADDRESS>

    Dated: December 21, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018-28315 Filed 12-27-18; 8:45 am]
 BILLING CODE 8011-01-P