[Federal Register: October 23, 2008 (Volume 73, Number 206)]
[Notices]
[Page 63224-63225]
[DOCID:fr23oc08-114]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58779; File No. SR-NYSE-2008-78]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Granting Approval of Proposed Rule Change Amending NYSE Rule 18 To
Allow NYSE Alternext US LLC To Participate in the Compensation Fund
Established by NYSE To Reimburse Claimants for Losses Associated With
NYSE-Operated System Failures

October 14, 2008.

I. Introduction

    On August 26, 2008, the New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change amending NYSE Rule 18 to allow NYSE Alternext US
LLC (``NYSE Alternext'' \3\) to participate in the compensation fund
established by NYSE to reimburse claimants for losses associated with a
malfunction of the Exchange's physical equipment, devices, and/or
programming which results in an incorrect execution or no execution of
an order that was received in Exchange systems (an ``Exchange systems
malfunction''). The proposed rule change was published for comment in
the Federal Register on September 9, 2008.\4\ The Commission received
no comments on the proposal. This order approves the proposed rule
change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ NYSE Alternext US LLC will be a self-regulatory organization
distinct from NYSE Euronext's European-market subsidy, NYSE
Alternext. When used throughout this order, ``NYSE Alternext''
refers to NYSE Alternext US LLC.
    \4\ See Securities Exchange Act Release No. 58450 (September 2,
2008), 73 FR 52439 (September 9, 2008) (SR-NYSE-2008-78)
(``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposal

    Through a series of mergers (the ``Mergers''), the American Stock
Exchange LLC (``Amex'') has become a subsidiary of NYSE Euronext and
was renamed NYSE Alternext US LLC.\5\ In connection with the Mergers,
NYSE Alternext will relocate all equities trading currently conducted
on or through the Amex legacy trading systems and facilities located at
86

Trinity Place, New York, New York, to the NYSE trading systems and
facilities located at 11 Wall Street, New York, New York (the ``NYSE
Alternext Trading Systems''), which will be operated by the NYSE on
behalf of NYSE Alternext (the ``Equities Relocation'').
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 58284 (August 1,
2008), 73 FR 46086 (August 7, 2008) (SR-Amex-2008-62) and Securities
Exchange Act Release No. 58673 (September 29, 2008) (SR-Amex-2008-
62).
---------------------------------------------------------------------------

    NYSE Rule 18 establishes a compensation fund and provides a
procedure for compensating NYSE member claimants in the event of an
Exchange system failure.\6\ The Commission recently approved Amex's
proposal to adopt a rule substantially similar to NYSE Rule 18.\7\ This
rule, NYSE Alternext Equities Rule 18, provides a procedure for
compensating NYSE Alternext member claimants in the event of an NYSE
Alternext systems failure. Specifically, under NYSE Alternext Equities
Rule 18, NYSE Alternext members and member organizations affected by a
failure of the NYSE Alternext Trading Systems would have the right to
submit claims for compensation to NYSE Alternext. NYSE Alternext's
Compensation Review Panel would then decide the validity of NYSE
Alternext claims.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release Nos. 56085 (July 17,
2007), 72 FR 40348 (July 24, 2007) (SR-NYSE-2007-09) (adopting NYSE
Rule 18); 56718 (October 29, 2007), 72 FR 62506 (November 5, 2007)
(SR-NYSE-2007-95) (approving certain amendments to NYSE Rule 18).
For a complete discussion of Rule 18, see the Notice, supra note 4.
    \7\ See Securities Exchange Act Release No. 34-58705 (October 1,
2008) 73 FR 58995 (October 8, 2008) (SR-Amex-2008-63).
---------------------------------------------------------------------------

    Because NYSE Alternext will operate on the Exchange's trading
systems after the Equities Relocation, NYSE proposes to amend NYSE Rule
18 to provide a mechanism for NYSE Alternext itself to seek
reimbursement from NYSE for the amounts that NYSE Alternext undertakes
to pay out to NYSE Alternext members under NYSE Alternext Equities Rule
18 as a result of an Exchange system malfunction.\8\ Thus, after the
NYSE Alternext Compensation Review Panel has determined the number and
amount of claims that NYSE Alternext deems valid, NYSE Alternext would
submit to the NYSE a separate claim for each valid claim made by NYSE
Alternext members or member organizations, subject to the same
requirements under NYSE Rule 18 as any other NYSE claimant. NYSE
Alternext will not, however, be required to provide verbal notice of
its claims to the Exchange's Division of Floor Operations.
---------------------------------------------------------------------------

    \8\ NYSE Alternext members and member organizations would not be
able to submit their claims directly to the NYSE.
---------------------------------------------------------------------------

    In the event that the total amount of valid claims by NYSE members
and NYSE Alternext exceeds the available funds in the NYSE Rule 18
compensation fund, NYSE Alternext would receive a partial payment of
claims pursuant to NYSE Rule 18(c), and NYSE Alternext's obligation to
compensate its members for valid claims would be reduced by a like
percentage.\9\ In the event that a reduction is required, in
calculating any such reduction, NYSE officials would consider each
claim submitted by NYSE Alternext as a separate claim, so that all
claimants from both the Exchange and NYSE Alternext will share
equitably from the compensation fund.
---------------------------------------------------------------------------

    \9\ In the Notice, NYSE stated that it does not anticipate that
the additional claims by NYSE Alternext would create a substantial
burden on the fund in the event of a system malfunction in view of:
(i) The probable volume of trading on NYSE Alternext; (ii) the fact
that to date, the existing compensation fund has been sufficient to
pay all valid claims in full; and (iii) the current amount available
in the supplemental fund. Notice at 52440.
---------------------------------------------------------------------------

    NYSE also proposes technical changes to NYSE Rule 18, including
corrections to the numbering of certain subparagraphs of the Rule.

III. Discussion and Commission Findings

    The Commission has carefully reviewed the proposed rule change and
finds that it is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\10\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\11\ which,
among other things, requires that the rules of a national securities
exchange be designed to promote just and equitable principles of trade,
to foster cooperation and coordination with persons engaged in
regulating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
The Commission believes that the proposed amendments to NYSE Rule 18
provide for a fair and reasonable process by which NYSE Alternext may
participate in the compensation fund established by the Exchange to
reimburse claimants for losses suffered due to a malfunction of systems
operated by the Exchange.
---------------------------------------------------------------------------

    \10\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change (SR-NYSE-2008-78) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-25319 Filed 10-22-08; 8:45 am]

BILLING CODE 8011-01-P


1001 G S T RE E T, N. W. SUI T E 500 WE ST WAS HIN GTON, D. C. 2 0 0 0 1 TE LE P HONE 2 0 2 . 4 3 4 . 4 1 0 0 FAC S IMI LE 2 0 2 . 4 3 4 . 4 6 4 6 WWW. KHLAW. COM WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. KELLER AND HECKMAN LLP S e r v i n g B u s i n e s s t h ro u g h La w a n d S c i e n c e ® November 18, 2004 Via E mail at ( sharkey. susan@ epa. gov)

Susan Sharkey 7406M USEPA Headquarters Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 Re: Supplemental Submission on Canola Oil, Xylitol, Soybean Meal and Fats and Glyceridic Oils, Vegetable Dear Ms. Sharkey:

The following information is submitted by the Coalition consisting of the Corn Refiners Association, the National Oilseed Processors Association, the Institute of Shortening and Edible Oils, the National Cotton Council of America, and the Soy Protein Council as a supplement to its Petition dated December 30, 2003, to partially exempt certain food related chemical substances from TSCA Inventory Update Reporting requirements, in 2006. This Supplemental Submission responds to a voicemail inquiry by you, in mid October 2004, seeking additional information on Canola Oil, Xylitol, Soybean Meal, and Fats and Glyceridic Oils, Vegetable.

I. Summary A. Toxicity 1. Canola Oil. According to EPA's Office of Pesticide Programs canola oil " has low chronic toxicities". In addition, FDA has granted " generally recognized as safe" ( GRAS) status to low erucic acid rapeseed oil for use as an edible fat or oil in human food. ( It should be noted that canola and low erusic acid rapeseed oil (< 2.0% erusic acid) are essentially the same. The FDA issued a final rule in the Federal Register of December 29, 1998 ( Vol. 53, No. 250, P. 52682) revising its regulations { 21CFR184.1555( c)] to include " canola oil" as the alternate common and usual name for low erusic rapeseed oil.) Canola oil is an edible substance that is readily metabolized by humans. There is adequate information available from literature sources to characterize the toxicity of canola oil.

2. Xylitol. Acute toxicity end points for xylitol are all greater than 8 gm/ kg   i. e., virtually non toxic. Inhalation of aerosolized iso osmotic xylitol was well tolerated by naive and atopic mice, and by healthy human volunteers. Xylitol may be safely used in foods for special Herb Estre i c he r ( 2 0 2 ) 4 3 4  4 3 3 4 e s t r e i c h er@ k hl aw. com Susan Sharkey November 9, 2005 Page 2 KELLER AND HECKMAN LLP L AW O F F I C E S WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. dietary uses, provided the amount used is not greater than that required to produce its intended effect. The only citation found that indicated any toxicity was to an existing E. coli C mutant strain.

3. Soybean meal. Soybean meal is considered safe as an animal feed. Although there are some reports in the literature that raw soybean meal may cause some enlargement of the pancreas of growing chicks and rats, soybean meal is heat treated before use to remove the constituents that may cause these effects.

4. Fats and Glyceridic Oils. The acute toxicity endpoint for an intravenous study on rabbits exposed to fats and glycederic oils was 840 mg/ kg. Studies on exposure to vegetable oil mist in manufacturing settings have shown that " vegetable oil mists seem to have little adverse effect on the lungs and do not produce significant organic disease or toxic effects when exposures are kept under reasonable control." The Occupational Safety and Health Administration ( OSHA) Permissible Exposure Limit is 15 mg/ m3 for total exposure and 5 mg/ m3 for the respirable fraction.

B. Ecotoxicity and Environmental Fate According to USDA, " Vegetable oils have superb environmental credentials, such as being inherently biodegradable, having low eco toxicity and low toxicity towards humans," EPA notes that " Although the Agency does not have toxicity test results for nontarget insects, fish, and other wildlife directly exposed to canola oil, numerous metabolic studies on the dietary effects and metabolism of canola in birds, mammals, and fish are reported in the literature. Ecological effects data for terrestrial and aquatic animals, and nontarget plants for canola were waived for the same reasons given above; principally, the low toxicity of the product, and its rapid degradation in the environment." Two studies looking at exposures of tropical fish and coral to vegetable derived lubricants ( VDL) and mineral derived lubricants ( MDL) showed that VDL was less toxic. Studies with sunflower oil and linseed oil resulted in longer degradation time for sunflower oil, but a study with VDL and MDL indicated significantly faster degradation of VDL.

C. Physical Properties Physical properties data are limited. Data for canola oil are included below and information for xylitol and vegetable oil are included in the MSDS information attached at the end of this paper. Susan Sharkey November 9, 2005 Page 3 KELLER AND HECKMAN LLP L AW O F F I C E S WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. II. Substance specific Information A. Canola Oil http:// www. epa. gov/ pesticides/ biopesticides/ ingredients/ tech_ docs/ tech_ 011332. htm, Canola EPA Technical data sheet 1. Toxicity Much of what is known about the toxicology and environmental effects and fate of Canola Oil is summarized in the above referenced EPA Technical data sheet supporting the registration of canola based products as biopesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (" FIFRA"). The Office of Pesticide Programs ( OPP) has waived the generic data requirements for canola oil, except for certain technical chemistry information, in light of its low toxicity. Available literature indicates that this substance has low chronic toxicities. In addition, FDA has granted GRAS status to low erucic acid rapeseed oil for use as an edible fat or oil in human food. Canola oil is an edible substance that is readily metabolized by humans.

There is adequate information available from literature sources to characterize the toxicity of canola oil. These studies indicate that canola oil's nutritional and toxicological profiles are similar to those of other vegetable oils ( 50FR 3745, 3752) ( Kramer et. al., 1983). Moreover, the available literature indicates that the use of this substance as a component of food is safe. Data available on soybean oil, discussed in Reregistration Eligibility Decision ( RED): Flower and Vegetable Oils EPA 738 R 93 031 December, 1993 also support the low toxicity of canola oil. There are no incident reports on file for low erucic acid canola oil. Canola oil has a non toxic mode of action for the target pests.

Acute toxicity data were submitted to OPP in support of the end use product registrations for NEU1161, which contains the active ingredients: 89.5% canola oil and 0.5% pyrethrins. NEU1161 is classified as toxicity category IV ( virtually non toxic) for acute inhalation and primary eye toxicity. These data are considered adequate to support all three canola formulations that are registered with EPA: NEU1160 Vegetable Oil Spray, NEU1161, and NEU1161 RTU. It should be noted, however, that the NEU1160 and NEU1161 RTU products contain either no or substantially less pyrethrin, respectively, and are thus likely to have a lower acute toxicity than the NEU1161 product.

2. Ecological Toxicity: Numerous metabolic studies on the dietary effects and metabolism of canola oil in birds, mammals, and fish are reported in the literature. Susan Sharkey November 9, 2005 Page 4 KELLER AND HECKMAN LLP L AW O F F I C E S WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. Ecological effects data for terrestrial and aquatic animals, and nontarget plants (?) for canola were waived by the Office of Pesticide Programs principally because of the low toxicity of the product, and its rapid degradation in the environment.

3. Physical Properties for Canola Oil Material Safety Data Sheet PHYSICAL STATE Liquid COLOR Yellow ODOR Slight SPECIFIC GRAVITY @ 25 ° C 0.91 0.92 VAPOR DENSITY N/ A FLASH POINT ( Cleveland closed cup) > 329 ° C VAPOR PRESSURE N/ A SOLUBILITY IN H2O Insoluble pH N/ A VOLATILES (%) < 0.1 Canola Oil   Exemption from Requirements of a Tolerance Under Section 408 of the FFDCA ( 63 FR 18326 29 ( April 15, 1998))

In connection with the grant of an exemption from tolerance for the use of canola oil on/ in food under 408( b)( 2)( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), EPA reviewed the scientific data and other relevant information on the dietary risk associated with consumption of canola oil food residues. EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children, to canola oil. Data waivers were granted for acute oral, dermal, inhalation, and eye toxicity, dermal sensitization, genotoxicity, reproductive and developmental toxicity, subchronic ( 90 day) oral and inhalation toxicity, and teratogenicity. The waivers were granted based on the long history of use of canola as an edible fat and oil in food without any indication of deleterious effects; its low toxicity; its natural occurrence as an oil extracted from plants; its low erucic acid ( less than 2%) content; its conformity with 21 CFR 184.1555( c); and, its classification by FDA as " generally recognized as safe" ( GRAS) for use as an edible fat or oil in human food. Available toxicity data on vegetable oils from the open literature and the Reregistration Eligibility Decision document for Flower and Vegetable Oils ( EPA 738 R 93 031) supported this finding. Susan Sharkey November 9, 2005 Page 5 KELLER AND HECKMAN LLP L AW O F F I C E S WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. 4. Other Literature Findings: http:// www. ncbi. nlm. nih. gov/ entrez/ query. fcgi? cmd= Retrieve& db= pubmed& dopt= Abstr act& list_ uids= 12909273 Twenty Wistar male rats, with ages varying from 21 days to 12 months, were fed with diets supplemented by soybean oil ( S group), canola oil ( CA group), lard and egg yolk ( LE group), and canola plus lard and egg yolk ( CA+ LE group). The LE group presented the highest heart mass/ body mass ratio and the highest blood pressure as well. The aortic structure suffered a number of alterations, from CA rats group ( minor alterations) to LE and CA+ LE rats group ( major alterations). The CA group showed the smallest aorta thickness. No significant differences among groups were found concerning the number of aortic lamellae and the density of tunica media smooth muscle nuclei. Surface density of the aortic lamellae was greater in the CA group and smaller in the LE group. These results suggest that the dietary intake of canola oil could attenuate the aorta structure aging process with a favorable BP maintenance. Susan Sharkey November 9, 2005 Page 6 KELLER AND HECKMAN LLP L AW O F F I C E S WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. B. Xylitol 1. Toxicity Xylitol is listed in Section 172.395 of the FDA regulations as a direct food additive. Section 172.395 states that " Xylitol may be safely used in foods for special dietary uses, provided the amount used is not greater than that required to produce its intended effect."

2. Other Information on Xylitol: http:// www. cdc. gov/ niosh/ rtecs/ zfc3500. html 1. ACUTE TOXICITY DATA AND REFERENCES:

ROUTE/ ORGANISM DOSE EFFECT REFERENCE intramuscular mouse lethal dose ( 50 percent kill): 10,200 mg/ kg N/ R NIIRDN  ,297,1990 intramuscular rat lethal dose ( 50 percent kill): 15 gm/ kg N/ R NIIRDN  ,297,1990 intraperitoneal mouse lowest published lethal dose: 22,100 mg/ kg N/ R RPTOAN 34,124,1971 intravenous mouse lethal dose ( 50 percent kill): 8,500 mg/ kg N/ R NIIRDN  ,352,1995 intravenous rat lethal dose ( 50 percent kill): 10,800 mg/ kg N/ R NIIRDN  ,297,1990 intravenous rabbit lethal dose ( 50 percent kill): 4 gm/ kg Biochemical: Metabolism ( intermediary): Other FEPRA7 31,726,1972 oral mouse lethal dose ( 50 percent kill): 12,500 mg/ kg Behavioral: General anesthetic Gastrointestinal: Ulceration or bleeding from stomach Liver: Other changes GISAAA 36( 2), 25,1971 oral rat lethal dose ( 50 percent kill): 16,500 mg/ kg N/ R NIIRDN  ,297,1990 oral rabbit lethal dose ( 50 percent kill): 25 gm/ kg Behavioral: General anesthetic GISAAA 36( 2), 25,1971 Susan Sharkey November 9, 2005 Page 7 KELLER AND HECKMAN LLP L AW O F F I C E S WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. Gastrointestinal: Ulceration or bleeding from stomach Liver: Other changes subcutaneous mouse lethal dose ( 50 percent kill): 18,300 mg/ kg N/ R NIIRDN  ,297,1990 subcutaneous rat lethal dose ( 50 percent kill): > 25 gm/ kg N/ R NIIRDN  ,297,1990 3. Other Literature Findings: http:// www. pubmedcentral. nih. gov/ articlerender. fcgi? artid= 221841 D Arabitol was observed to be toxic to many laboratory strains of Escherichia coli K 12, but xylitol was found to be toxic to only one existing E. coli C mutant strain. Xylitol toxicity is prevented by fructose in both wild type and mutant strains. http:// www. ncbi. nlm. nih. gov/ entrez/ query. fcgi? cmd= Retrieve& db= pubmed& dopt= Abstract& list _ uids= 15377394.

Safety assessment of inhaled xylitol in mice and healthy volunteers: http:// www. ncbi. nlm. nih. gov/ entrez/ query. fcgi? cmd= Retrieve& db= pubmed& dopt= Abstract& list _ uids= 15377394. CONCLUSIONS: Inhalation of aerosolized iso osmotic xylitol was welltolerated by naive and atopic mice, and by healthy human volunteers.

C. SOYBEAN MEAL 1. Toxicity http:// www. asa europe. org/ pdf/ evaluation. pdf There are a number of reports in the public literature indicating that raw soybean meal may negatively impact the growth of rats, but this potential effect is eliminated when the raw soybean meal is cooked or otherwise heat processed, as is commonly done to improve the nutritional value and digestibility of soybean meal. See http:// www. fao. org/ docrep/ X5738E/ x5738e0l. htm Initial studies on the nutritive value of soybeans were done on rats. Osborne and Mendel ( 1917) and Hayward et al. ( 1936) observed that full fat or fat extracted raw soybean meal inhibited growth of rats, and growth inhibition was overcome in cooked or heat processed soybeans. Pigs also grew better on diets containing heat processed soybeans rather than raw soybeans ( Robison, 1930; Vestal and Shrewsbury, 1932; Hayward et al., 1935). Similar results Susan Sharkey November 9, 2005 Page 8 KELLER AND HECKMAN LLP L AW O F F I C E S WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. were reported for growing chickens ( Wilgus et al., 1936; Hayward et al., 1937). Deleterious substances which were inactivated by heat treatment were not characterized for many years, and serious attempts were only made to incorporate soybean meal in animal feeds from World War II onwards.

Soybeans also are reported to contain several protease inhibitors, generally called trypsin inhibitors ( Read and Haas, 1938; Ham and Sandstedt, 1944; Bowman, 1944; Ham et al., 1945; Kunitz, 1945; Borcher et al., 1947, 1948; Almquist and Merrit, 1952; Birk and Gertler, 1961; Birk et al., 1963; Liener and Kakade, 1980), hemagglutinin or lectins ( Liener, 1951; Pallansch and Liener, 1953; Jaffe, 1980) and estrogens ( Carter et al., 1955; Booth et al., 1960; Naim et al., 1974; Wada and Yuhara, 1964). Saponins ( Wolf, 1966; Gestetner et al., 1966; Fenwick and Oakenfull, 1981), and urease ( Caskey and Knapp, 1944) are also present in raw soybeans, but it is doubtful that any of these substances are deleterious to monogastric animals, such as humans.

Raw soybean meal has also been reported to cause enlargement of the pancreas of growing chicks ( Chernick et al., 1948; Applegarth et al., 1964) and rats ( Rackis, 1965; Khayambashi and Lyman, 1966). The causative agents are inactivated by heat treatment ( Brambila et al., 1961; Saxena et al., 1963; Garlich and Nesheim, 1966; Gertler et al., 1967).

Liener ( 1951) observed toxicity of hemagglutinin, or lectin, when injected intraperitoneally into rats and chicks, and there are suggestions that the destruction of lectins by heat may explain the effect of heat treatment on inactivating any potential growth inhibition associated with raw soybean meal ingestion. Hemagglutinin is a multicomponent entity that is also inactivated by heat treatment of soybeans.

D. Fats and Glycederic Oils, Vegetable http:// www. osha. gov/ SLTC/ healthguidelines/ vegetableoilmist/ recognition. html 1. Toxicology a. Effects on Animals: The mists of vegetable oils are considered biologically inert. High oral doses of vegetable oils have a laxative effect [ ACGIH 1991]. Sunflower oil was lethal in rats when added to the animal's diet in an amount corresponding to 45 percent of total diet calories for a period of 4.5 months [ NLM 1995]. Direct instillation of vegetable oil into rabbit lungs is expected to induce acute bronchitis [ ACGIH 1991].

b. Effects on Humans: Most vegetable oil mists are biologically inert and are, therefore, considered to be nuisance particulates. Vegetable oil mists seem to have little adverse effect on the lungs and do not produce significant organic disease or toxic effects when exposures are kept under reasonable control [ ACGIH 1991]. Oils from certain plants such as castor bean, sesame, acacia, and cashew nut have caused occupational dermatitis and respiratory irritation. Exposure to acacia gum oil has been associated with occupational asthma and dermatitis [ ACGIH 1991]. Susan Sharkey November 9, 2005 Page 9 KELLER AND HECKMAN LLP L AW O F F I C E S WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. Ingestion of cottonseed oil that also contained some camphorated oils has caused clinical toxicity, coma, and death [ ACGIH 1991].

http:// www. ars. usda. gov/ research/ publications/ Publications. htm? seq_ no_ 115= 145286 Vegetable oils have superb environmental credentials, such as being inherently biodegradable, having low eco toxicity and low toxicity towards humans, being derived from renewable resources and contributing no volatile organic compounds ( VOC).

http:// www. cdc. gov/ niosh/ rtecs/ yx1c3a90. html 2. ACUTE TOXICITY DATA AND REFERENCES:

ROUTE/ ORGANISM DOSE EFFECT REFERENCE intravenous rabbit lethal dose ( 50 percent kill): 840 mg/ kg N/ R APTOA6 45,352,1979 3. REVIEWS:

ORGANIZATION STANDARD REFERENCE American Conference of Governmental Industrial Hygienists ( ACGIH) Threshold Limit Value time weighted average 10 mg/ m3 DTLVS* TLV/ BEI, 2002 a)

4. STANDARDS AND REGULATIONS:

ORGANIZATION STANDARD REFERENCE Occupational Safety and Health Administration ( OSHA) Permissible Exposure Limit ( General Industry) 8 hour time weighted average 15 mg/ m3, total dust CFRGBR 29,1910.1000,1994 Occupational Safety and Health 8 hour time weighted CFRGBR Susan Sharkey November 9, 2005 Page 10 KELLER AND HECKMAN LLP L AW O F F I C E S WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. Administration ( OSHA) Permissible Exposure Limit ( General Industry) average 5 mg/ m3, respirable fraction 29,1910.1000,1994 5. NIOSH DOCUMENTATION AND SURVEILLANCE:

ORGANIZATION STANDARD or SURVEY REFERENCE National Institute for Occupational Safety and Health ( NIOSH) Recommended Exposure Level TO VEGETABLE OIL MIST, respirable fraction air time weighted average 5 mg/ m3 NIOSH* DHHS # 92 100,1992 National Institute for Occupational Safety and Health ( NIOSH) Recommended Exposure Level TO VEGETABLE OIL MIST, total dust air 10 hour time weighted average 10 mg/ m3 NIOSH* DHHS # 92 100,1992 2. Environmental Fate http:// www. ncbi. nlm. nih. gov/ entrez/ query. fcgi? cmd= Retrieve& db= pubmed& dopt= Abstract& list _ uids= 12738220 The effects of a simulated spill of sunflower oil in salt marsh sediments were compared in an experiment with linseed oil. Sunflower and linseed oil penetrated the sediments at the same rates, but different adsorption of the oils onto sediment particles resulted in the establishment of anaerobic conditions at shallower depths in sediments contaminated with linseed oil than with sunflower oil. The total lipid content of sunflower oil contaminated sediments remained almost stable for six months, while only 40% of linseed oil remained in the sediment after two months. Numbers of culturable heterotrophic bacteria and aerobic oil degrading bacteria in muddy sediment increased rapidly in response to the presence of the oils, but bacterial numbers in sandy sediments increased more slowly for sunflower oil. Changes in fatty acid composition indicate similar degradation pathways for both oils, however, sunflower oil degraded more slowly than linseed oil and, thus, has the potential for longer lasting effects in marine environments.

http:// www. ncbi. nlm. nih. gov/ entrez/ query. fcgi? cmd= Retrieve& db= pubmed& dopt= Abstract& list _ uids= 14987803 Susan Sharkey November 9, 2005 Page 11 KELLER AND HECKMAN LLP L AW O F F I C E S WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. 3. Ecotoxicity a. Testing the ecotoxicology of vegetable versus mineral based lubricating oils: Degradation rates using tropical marine microbes.

Degradation of some VDL [ vegetable derived lubricant] was observed by day 7, with the 2 stroke VDL markedly consumed by mangrove microorganisms and the hydraulic VDL degraded by both microorganism communities after this short period. All of the VDL groups were significantly more degraded than the comparable MDLs mineral oil lubricants over 14 days in the presence of either mangrove or coral reef microbial communities.

http:// www. ncbi. nlm. nih. gov/ entrez/ query. fcgi? cmd= Retrieve& db= pubmed& dopt= Abstract& list _ uids= 14987804 b. Testing the ecotoxicology of vegetable versus mineral based lubricating oils: Induction of mixed function oxidase enzymes in barramundi, Lates calcarifer, a tropical fish species.

This study is the first investigation into the use of this key commercial species in tropical North Queensland, Australia in stress assessment of potential hydrocarbon pollution using ethoxyresorufin O deethylase ( EROD) induction. Our results indicated that barramundi provide a wide range of inducible rates of EROD activity in response to relevant organic stressors. The vegetable and mineral based lubricants induced significant EROD activity at 1.0 mg kg( 1) and there was no significant difference between the two oil treatments at that concentration. At increasing concentrations of 2 and 3 mg kg( 1), the mineral based lubricant resulted in slightly higher EROD activity than the vegetable based lubricant. The EROD activity of control and treated barramundi are found to be within ranges for other species from temperate and tropical environments. These results indicate that vegetable based lubricants may be less stressful to barramundi than their mineral counterparts at concentrations of lubricant > or = 2 mg kg( 1).

http:// www. ncbi. nlm. nih. gov/ entrez/ query. fcgi? cmd= Retrieve& db= pubmed& dopt= Abstract& list _ uids= 14987805 c. The ecotoxicology of vegetable versus mineral based lubricating oils: Coral fertilization and adult corals The coumarin free [ vegetable derived lubricants] VDL 2 exhibited significantly less toxicity towards the adult corals than all of the other oil types tested, with the only measurable effect being a slight but significant drop in photosynthetic efficiency at 280 microg l( 1). Susan Sharkey November 9, 2005 Page 12 KELLER AND HECKMAN LLP L AW O F F I C E S WAS H IN GT O N, D . C. BR US S E LS SA N F RA NC I S C O This document was delivered electronically. MSDS   click on icon to open " canola msds. pdf" " veg oil msds. pdf" " xylitol msds. pdf"

* * *

We trust this Supplemental Submission serves your needs by demonstrating the low potential for toxicity of the above referenced compounds. If you have any questions, do not hesitate to contact us.

Sincerely,

Original Signed By Herbert Estreicher


[Federal Register Volume 76, Number 232 (Friday, December 2, 2011)]
[Notices]
[Page 75542]
[FR Doc No: 2011-30970]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL12-11-000]

Rail Splitter Wind Farm, LLC v. Ameren Services Company Midwest
Independent Transmission, System Operator, Inc.; Notice of Complaint

    Take notice that on November 23, 2011, pursuant to section 206 of
the Federal Power Act (FPA), 16 U.S.C. 824e, and Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedures, 18 CFR 385.206, Rail Splitter Wind Farm, LLC (Rail
Splitter or Complainant) filed a formal complaint against Ameren
Services Company (Ameren) and the Midwest Independent Transmission
System Operator, Inc. (collectively, Respondents) challenging the rate
under the Facilities Services Agreement between Rail Splitter and
Ameren dated January 10, 2010 as unjust and unreasonable, in violation
of sections 205 and 206 of the FPA.
    The Complainant certifies that copies of the complaint were served
upon Respondents.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 13, 2011.

    Dated: November 25, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-30970 Filed 12-1-11; 8:45 am]
BILLING CODE 6717-01-P


46616 Federal Register / Vol. 68, No. 151 / Wednesday, August 6, 2003 / Notices F. Safety Determination 1. U. S. population. The use of products containing yeast extract hydrolysate, which lacks toxicity and is used in such low concentrations, is compatible with EPA's objectives to register reduced risk pesticides. Based on its lack of toxicity and the fact that yeast extracts are already present in the diet, there is reasonable certainty that no harm will result from aggregate exposure of the U. S. population, including infants and children, to residues of yeast extract hydrolysate. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. Yeast extract hydrolysate is applied at low rates and with its lack of toxicity and its history of safe use, it does not pose a safety concern. 2. Infants and children. Based on the lack of toxicity of yeast extract hydrolysate, there is a reasonable certainty that no harm to children or adults will result from aggregate exposure to yeast hydrolysate. Exempting yeast extract hydrolysate from the requirement of a tolerance should pose no significant risk to humans.

G. Effects on the Immune and Endocrine Systems Yeast extract hydrolysate is a naturally occurring biochemical. To date there is no evidence to suggest that yeast extract hydrolysate functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.

H. Existing Tolerances There are no existing tolerances for yeast extract hydrolysate in the United States.

I. International Tolerances There are no known approved Codex maximum residue levels established for residues of yeast extract hydrolysate. [ FR Doc. 03   19916 Filed 8   5   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0240; FRL   7319   3]

Cyromazine; Notice of Filing of Pesticide Petitions to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0240, must be received on or before September 5, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   3194; e mail address: brothers. shaja@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does This Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Industry ( NAICS 111, 112, 311, 32532), e. g., Crop production, Animal production, Food manufacturing, and Pesticide manufacturing. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0240. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and VerDate jul< 14> 2003 19: 35 Aug 05, 2003 Jkt 200001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06AUN1. SGM 06AUN1 46617 Federal Register / Vol. 68, No. 151 / Wednesday, August 6, 2003 / Notices without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2003   0240. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID Number OPP   2003   0240. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID Number OPP   2003   0240. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP   2003   0240. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI to the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2);

VerDate jul< 14> 2003 19: 35 Aug 05, 2003 Jkt 200001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06AUN1. SGM 06AUN1 46618 Federal Register / Vol. 68, No. 151 / Wednesday, August 6, 2003 / Notices however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: July 28, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions The petitioner summary of the pesticide petitions are printed below as required by FFDCA section 408( d)( 3). The summary of the petitions were prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Interregional Research Project Number 4 ( IR 4)

PP 2E6507 and PP 2E6510 EPA has received pesticide petitions ( PP 2E6507 and PP 2E6510) from IR 4, 681 U. S. Highway # 1 South, North Brunswick, NJ 08902   3390 proposing, pursuant to section 408( d) of FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR 180.414 by establishing tolerances for residues of cyromazine, ( N cyclopropyl 1,3,5 triazine 2,4,6 triamine) in or on the following raw agricultural commodities: Leek; onion, green; onion, potato; onion, tree; onion, welsh; and shallot, fresh leaves at 3.0 parts per million ( ppm) ( 2E6507), garlic, bulb; garlic great headed, bulb; onion, dry bulb; rakkyo, bulb; and shallot, bulb at 0.2 ppm ( 2E6507), vegetable brassica, leafy, group 5, except broccoli at 10 ppm ( 2E6510), broccoli at 1.0 ppm, turnip, greens; cabbage, abyssinian; cabbage, seakale; and hanover salad, leaves at 10 ppm, and kidney of cattle, goats, hogs, horses, and sheep at 0.2 ppm, and meat byproducts of cattle, goats, hogs, horses, and sheep at 0.05 ppm ( 2E6510). IR 4 also proposed that tolerances for residues of cyromazine in or on dry bulb onion at 2.0 ppm and green onion at 0.1 ppm established under 40 CFR 180.414( a) and Chinese cabbage and Chinese mustard at 3.0 ppm established under 40 CFR 180.414( c) be deleted when the proposed tolerances are established. Chinese cabbage and Chinese mustard are included in the Brassica leafy vegetable group. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petitions. Additional data may be needed before EPA rules on the petitions. This summary has been prepared by the Syngenta Crop Protection Incorporated.

A. Residue Chemistry 1. Plant metabolism. The metabolism of cyromazine in plants is adequately understood for the purposes of these tolerances. 2. Analytical method. Methods AG 408 and AG 417 as listed in the Food and Drug Administration's Pesticide Analytical Manual ( PAM), Vol II are adequate to enforce the proposed tolerances. 3. Magnitude of residues. Residue field tests were conducted in typical growing regions for Brassica and bulb vegetables and turnip tops. The data collected support the proposed tolerances of 10.0 ppm for Brassica leafy vegetables, 10.0 ppm for turnip tops and 3.0 ppm for bulb vegetables.

B. Toxicological Profile 1. Acute. A rat acute oral toxicity study with a lethal dose ( LD) 50 of approximately 3,387 milligrams/ kilogram ( mg/ kg) ( toxicity category III; moderately toxic). A rat acute dermal toxicity study with a LD50 greater than 3,100 mg/ kg ( toxicity category III; moderately toxic). A rat acute inhalation study with a lethal concentration ( LC) 50 greater than 2.9 mg/ kg ( toxicity category IV; slightly toxic). A primary eye irritation study in the rabbit that showed no eye irritation. A primary dermal irritation study in the rabbit that showed mild irritation ( toxicity category; IV). A dermal sensitization study in the guinea pig that showed no sensitization. 2. Genotoxicity. Studies on gene mutation and other genotoxic effects showed no evidence of point mutation in an Ames test; no indication of mutagenic effects in a dominant lethal test; and no evidence of mutagenic effects in a nucleus anomaly test in Chinese hamsters. 3. Reproductive and developmental toxicity. In a rat developmental toxicity study, the maternal no observed adverse effect level ( NOAEL) was 100 mg/ kg/ day. The maternal lowest observed adverse effect level ( LOAEL) was 300 mg/ kg based on decreased body weight gain and clinical observations. The developmental NOAEL was 300 ppm. The developmental LOAEL was 600 mg/ kg based upon an increase of minor skeletal variation. In a rabbit developmental toxicity study, the maternal NOAEL was 10 mg/ kg. The maternal LOAEL was 30 mg/ kg based upon decreased body weight gain and food consumption. The developmental NOAEL/ LOAEL was greater than or equal to 60 mg/ kg. In a multi generation study in rats, the systemic NOAEL was 30 ppm ( 1.5 mg/ kg). The systemic LOAEL was 1,000 ppm ( 50 mg/ kg) based upon decreased body weights associated with decreased food consumption. The developmental/ offspring systemic NOAEL was 1,000 ppm. The developmental/ offspring systemic LOAEL was 3,000 ppm ( 150 mg/ kg) based upon decreased body weight at birth through weaning. There were no effects on reproductive parameters at the highest dose tested ( HDT) ( 3,000 ppm). 4. Subchronic toxicity. In a 6   month feeding study in dogs, the NOAEL was 30 ppm ( 0.75 mg/ kg). The LOAEL was 300 ppm ( 7.5 mg/ kg) based upon decreased hematocrit and decreased hemoglobin. Groups of male and female beagle dogs ( 4/ sex/ dose) were fed diets containing cyromazine at 0, 30, 300, or 3,000 ppm ( 0, 0.75, 7.5, or 75 mg/ kg/ day, respectively) for 6   months. No treatment related effects were observed in survival, clinical signs or body weight parameters. Pronounced effects on hematologic parameters were manifested as decreases in hematocrit and hemoglobin levels at 300 and 3,000 ppm. 5. Chronic toxicity. In a 24   month feeding study in rats the NOAEL for the study was 30 ppm ( 1.5 mg/ kg/ day). The LOAEL was 300 ppm ( 15.0 mg/ kg) based on decreased body weight. In a 24   month mouse chronic feeding carcinogenicity study the NOAEL was 50 ppm ( 7.5 mg/ kg/ day). The LOAEL was 1,000 ppm ( 150.0 mg/ kg) based upon decreased body weight. There was no evidence of carcinogenicity at 3,000 ppm ( 450 mg/ kg). In a 24   month rat chronic feeding carcinogenicity study the NOAEL was greater than 3,000 ppm ( 150 mg/ kg) ( HDT). There was no evidence of carcinogenicity at 3,000 ppm. Cancer Peer Review Committee determined that there is no evidence of carcinogenicity in studies in either the mouse or rat. Based upon this determination it can be concluded that cyromazine does not pose a cancer risk.

VerDate jul< 14> 2003 19: 35 Aug 05, 2003 Jkt 200001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06AUN1. SGM 06AUN1 46619 Federal Register / Vol. 68, No. 151 / Wednesday, August 6, 2003 / Notices 6. Animal metabolism. The metabolism of cyromazine has been adequately characterized in the rat, goat, and chicken. 7. Metabolite toxicology. EPA has removed melamine, a metabolite of cyromazine, from the tolerance expression as a residue of toxicological concern. For more information on melamine, see the Federal Register of September 15, 1999 ( 64 FR 50043) ( FRL   6098   7). 8. Endocrine disruption. Cyromazine does not belong to a class of chemicals proven to have adverse effects on the endocrine system. There is no evidence that cyromazine has any effect on endocrine function in developmental or reproduction studies.

C. Aggregate Exposure 1. Dietary exposure   Food. For the purposes of assessing the potential dietary exposure under the proposed tolerances, Syngenta Crop Protection has estimated aggregate exposure from all crops for which tolerances are established. i. Acute. There were no toxicological effects attributed to a single exposure ( dose) observed in oral toxicity studies including the developmental toxicity studies in rats and rabbits. Therefore, there is a reasonable certainty of no harm from acute dietary exposure. ii. Chronic. The cyromazine chronic dietary exposure assessment utilized the Dietary Exposure Evaluation Model ( DEEM   ) , version 7.76 from Exponent. All consumption data from this assessment were taken from the USDA's Continuing Survey of Food Intake by Individuals ( CSFII) with the 1994   96 consumption database and the Supplemental CSFII children's survey ( 1998) consumption database. The cyromazine Tier III chronic dietary exposure assessment was based upon residue field trial results, and tolerance residues for crops when no field trial data were available. Anticipated residue estimates were used for milk, meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep; and for all other commodities tolerance level residues were assumed. The maximum percent crop treated values for cyromazine were obtained from the Doane's Market Survey Database ( 1999   2001) and used for lima beans ( 0.8%), cantaloupe ( 3.9%), peppers ( 8.6%), tomatoes ( 2.9%), celery ( 68.9%), lettuce ( 9.7%), spinach ( 19.5%), and onions ( 0.2%). For all other registered or proposed crop uses, it was assumed that 100% of these crops were treated. 2. Drinking water. EPA uses the FQPA Index Reservoir Screening Tool ( FIRST) to estimate pesticide concentrations in surface water and screening concentration in ground water ( SCIGROW to estimate pesticide concentrations in ground water. FIRST incorporates an index reservoir environment and includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact that processing ( mixing, dilution, or treatment) would have on the removal of pesticides from the water source. The primary use of these models by EPA is to provide a Tier I assessment to estimate the concentration of pesticides in drinking water. Estimated Environmental Concentrations ( EECs) of cyromazine in drinking water were determined for the highest use rate of cyromazine. Based on the model outputs, the EECs of cyromazine are 1.8 parts per billion ( ppb) for chronic exposure to ground water and 10 ppb for chronic exposure to surface water. 3. Non dietary exposure. Cyromazine is currently registered for commercial outdoor use on landscape ornamentals and commercial interiorscapes. There are no lawn or indoor residential uses and significant residential exposure is not expected.

D. Cumulative Effects When considering whether to establish, modify, or revoke a tolerance, section 408( b)( 2)( D)( v) requires that the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residue and `` other substances that have a common mechanism of toxicity.'' Neither Syngenta nor EPA has at this time, data available to determine whether cyromazine has a common mechanism of toxicity with other substances or the methodology to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, cyromazine does not appear to produce a toxic metabolite produced by other substances.

E. Safety Determination. 1. Acute risk. There were no toxicological effects observed in oral toxicity studies, including the developmental toxicity studies in rats and rabbits, that could be attributed to a single exposure ( dose). Since there is a reasonable certainty of no harm from acute dietary exposure, an acute aggregate risk assessment was not performed for cyromazine. 2. Chronic risk. The chronic dietary exposure risk analysis ( food only) showed that exposure from all established and these proposed tolerances would be 2.9% of the chronic reference dose ( cRfD) for the most exposed subpopulation, children 1 to 2 years old. EPA has determined that reliable data support using the standard margin of exposure and uncertainty factor ( 100 for combined interspecies and intraspecies variability) for cyromazine and an additional safety factor of 10X is not necessary to protect infants and children. 3. Drinking water. The chronic drinking water level of concern ( DWLOC) for the most exposed subpopulation ( children 1   6 years) is 728 ppb. Based upon the SCI GROW and FIRST model outputs, the EECs of cyromazine in surface water and ground water are below the chronic DWLOC; therefore, EPA should not have a concern regarding cyromazine in drinking water. 4. Non dietary exposure. Due to the nature of the non dietary use, the commercial use of cyromazine on landscape ornamentals will not result in any significant residential exposure. Syngenta has considered the potential aggregate exposure from food, water, and non occupational exposure routes and concluded that aggregate exposure is not expected to exceed 100% of the cRfD. Therefore, Syngenta has concluded that there is reasonable certainty that no harm will result from aggregate exposure to cyromazine residues.

F. International Tolerances.

The U. S. tolerances and Codex Maximum Residue Levels ( MRLs) are compatible for ruminant tissue, bell pepper, and tomato. Codex MRLs and U. S. tolerances are incompatible for milk, celery, cucumber, lettuce, melon, and mushroom. [ FR Doc. 03   20014 Filed 8   5   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0234; FRL   7317   6]

Benoxacor; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

VerDate jul< 14> 2003 19: 35 Aug 05, 2003 Jkt 200001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06AUN1. SGM 06AUN1


[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Rules and Regulations]
[Pages 34404-34405]
[FR Doc No: 2017-15505]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2017-0548]

Safety Zones; D-Day Conneaut Air Show, Conneaut, OH

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce a safety zone for the D-Day
Conneaut Air Show, on Lake Erie from 2 p.m.

through 5 p.m. on Friday, August 18, 2017 and from 2 p.m. through 5
p.m. on Saturday, August 19, 2017. This action is necessary to provide
for the safety of life and property on navigable waters during this
event. During the enforcement period, no person or vessel may enter the
respective safety zone without the permission of the Captain of the
Port Buffalo.

DATES: The regulation in 33 CFR 165.939(a)(32) will be enforced from 2
p.m. through 5 p.m. on Friday, August 18, 2017 and from 2 p.m. through
5 p.m. on Saturday, August 19, 2017.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email LT Ryan Junod, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Safety
Zone; D-Day Conneaut Air Show, Conneaut, OH, Lake Erie, Conneaut, OH
listed in 33 CFR 165. 939(a)(32) for the following event:
    D-Day Conneaut Air Show, Lake Erie, Conneaut, OH; The safety zone
listed in 33 CFR 165.939(a)(32) will be enforced from 2 p.m. through 5
p.m. on August 18, 2017 and August 19, 2017. The safety zone will
encompass all waters of Conneaut Township Park, Lake Erie, Conneaut, OH
within an area starting at 41[deg]57.71' N., 080[deg]34.18' W., to
41[deg]58.36' N., 080[deg]34.17' W., then to 41[deg]58.53' N.,
080[deg]33.55' W., to 41[deg]58.03' N., 080[deg]33.72' W., and
returning to the point of origin (NAD 83). This action is necessary to
provide for the safety of life and property on navigable waters during
this event. Pursuant to 33 CFR 165.23, entry into, transiting, or
anchoring within these safety zones during an enforcement period is
prohibited unless authorized by the Captain of the Port Buffalo or his
designated representative. Those seeking permission to enter one of
these safety zones may request permission from the Captain of Port
Buffalo via channel 16, VHF-FM. Vessels and persons granted permission
to enter this safety zone shall obey the directions of the Captain of
the Port Buffalo or his designated representative. While within the
safety zone, all vessels shall operate at the minimum speed necessary
to maintain a safe course.
    This notice is issued under authority of 33 CFR 165.939(a)(32) and
5 U.S.C. 552(a). In addition to this notice in the Federal Register,
the Coast Guard will provide the maritime community with advance
notification of these enforcement periods via Broadcast Notice to
Mariners and Local Notice to Mariners. If the Captain of the Port
Buffalo determines that this safety zone need not be enforced for the
full duration stated in this notice, he or she may use a Broadcast
Notice to Mariners to grant general permission to enter the respective
safety zone.

    Dated: July 18, 2017.
Joseph S. Dufresne,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2017-15505 Filed 7-24-17; 8:45 am]
 BILLING CODE 9110-04-P