Page 1 of 16 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES September August 29, 2003 MEMORANDUM SUBJECT: Tolerance Reassessment Decisions Completed by the Lower Toxicity Pesticide Chemical Focus Group FROM: Peter Caulkins, Associate Director Registration Division TO: Richard Keigwin, Acting Associate Director Special Review and Reregistration Division Please find attached the Focus Group Decision Documents for ( 1) fatty acids derived from soybean oil, ( 2) various salts of various fatty acids, ( 3) ascorbic acid and ascorbyl palmitate, and ( 4) isopropyl myristate. The nine tolerance exemptions for these chemicals in 40 CFR 180.1001 are reassessed.

If you have any comments or questions, please contact Kathryn Boyle at 703 305 6304.

Attachments ( 4) Page 2 of 16 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES September 27, 2003 MEMORANDUM FROM: Kathryn Boyle, Chair Lower Toxicity Pesticide Chemical Focus Group Registration Division TO: Susan Lewis, Acting Chief Minor Use, Inerts, and Emergency Response Branch Registration Division SUBJECT: Recommendation for Tolerance Reassessment The attached science assessment discusses the toxicity of ascorbic acid and ascorbyl palmitate. Based on the available information on ascorbic acid, also known as Vitamin C, and its role as an essential nutrient and its use as a food additive, a qualitative assessment was performed. Based on the available information on ascorbyl palmitate, its long history of safe use in cosmetics as an antioxidant, and the Food and Drug Administration ( FDA) determination of Generally Recognized as Safe ( 21 CFR 182.3149), a qualitative assessment was performed.

Based on its review and evaluation of the available information, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to residues of ascorbic acid and ascorbyl palmitate from their uses as inert ingredients in pesticide products. The ascorbic acid exemption from the requirement of a tolerance as established in 40 CFR 180.1001 ( c) is reassessed. Based on its lack of toxicity and its role as an essential human nutrient, the List classification of ascorbic acid as List 4A is confirmed. The ascorbyl palmitate exemptions from the requirement of a tolerance as established in 40 CFR 180.1001 ( c) and ( e) are reassessed. Based on its overall low toxicity including its acute toxicity profile and its ready biodegradation, ascorbyl palmitate is reclassified to List 4A Page 3 of 16 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES September 25, 2003 Memorandum Subject: Ascorbic Acid and Ascorbyl Palmitate: Antimicrobials Division Science Assessment Document for Tolerance Reassessment.

CAS No.: 50 81 7 ( Ascorbic acid) 137 66 6 ( Ascorbyl palmitate)

PC Code.: 900395 ( Ascorbic acid); 800155 ( Ascorbyl palmitate)

Chemical Class: Ascorbic acid and its fatty acid ester From: Deborah Smegal, Risk Assessor Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

Through: Norm Cook, Branch Chief Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

To: Lower Toxicity Pesticide Chemical Focus Group Kathryn Boyle, Chair Registration Division ( 7505C)

Background:

Attached is the Lower Toxicity Pesticide Chemical Focus Group's science assessment for ascorbic acid and ascorbyl palmitate. The purpose of this review is a reassessment of the exemption from the requirement of a tolerance. This assessment summarizes available information on the use, physical/ chemical properties, toxicological effects, exposure profile, and Page 4 of 16 environmental fate and ecotoxicity of these compounds. In performing this assessment, EPA has utilized reviews previously performed by EPA and relied on peer reviewed evaluations performed by the Food and Drug Administration ( FDA), Food and Agriculture Organization of the World Health Organization ( FAO/ WHO), and the Cosmetic Ingredient Review ( CIR) expert panel.

I. Executive Summary:

Ascorbic acid, commonly known as Vitamin C, is a naturally occurring, essential nutrient present in many fruits and vegetables. Ascorbyl palmitate is an ester of ascorbic acid with a long chain fatty acid ( palmitic acid). Ascorbic palmitate is readily metabolized to ascorbic acid in the human body, where it becomes active as vitamin C. Other significant sources of exposure include the many FDA approved uses as food additives, in dietary supplements ( as a source of Vitamin C), and cosmetic products. Ascorbyl palmitate is a common ingredient of over 500 cosmetic formulations, where is serves as an antioxidant. Both ascorbyl palmitate and ascorbic acid are classified by FDA as generally recognized as safe ( GRAS) substances for the preservation of foods ( 21 CFR 182.3149, 182.3013, 182.5013).

Both ascorbyl palmitate and ascorbic acid have a low order of oral and dermal toxicity. Ascorbic acid did not produce adverse developmental, reproductive or carcinogenic effects in animals. Both compounds have numerous beneficial effects, and a deficiency in ascorbic acid causes scurvy.

Ascorbic acid is naturally present in all aquatic and biotic systems; it is essential to animal life and is naturally synthesized by most plants, but not invertebrates, or fish. It is essential for normal growth and development, and thus is present in the majority of living organisms. Ascorbic acid is widely used as a dietary supplement in fish and chicken reared for food production. The available ecotoxicity data for ascorbyl palmitate indicate that it may be more toxic than ascorbic acid. However, based on its physical/ chemical properties, ascorbyl palmitate has low water solubility and is expected to have moderate to strong sorption to soils and sediments, fairly rapid microbial degradation, and negligible migration to surface water and groundwater. Thus, it is unlikely to result in significant risk.

Based on available information on ascorbic acid and ascorbyl palmitate, their expected use patterns, their safe history of use a food additives, their extensive use in commercially available cosmetics and their low toxicity, the Lower Toxicity Pesticide Chemical Focus Group has determined that a quantitative risk assessment is not required for these compounds.

II. Use Information:

The tolerance exemptions being reassessed in this document, the associated 40 CFR location, and the use pattern as an inert ingredient are listed in Table 1. Page 5 of 16 Table 1 Tolerance Exemptions Being Reassessed in this Document Tolerance Exemption Expression Inert PC Code Cas No. 40 CFR 180.1001 List Classification Use Pattern ( Pesticidal)

ascorbic acid 900395 50 81 7 ( c) 4A stabilizer, preservative ascorbyl palmitate 800155 137 66 6 ( c) 3 preservative in formulations applied to growing crops ( e) preservative in formulations applied to animals Ascorbic acid ( Vitamin C): Ascorbic acid is classified as a GRAS substance by FDA as a food additive permitted for direct addition to food for human consumption when used as a preservative and nutrient and/ or dietary supplement ( vitamin C supplement) ( 21 CFR 182.3013 and 182.5013, respectively). Ascorbic acid is also approved as a dough conditioner in cereal flours ( tolerance 200 ppm), breads and other bakery products ( 21 CFR 136 and 137); as an acidulant in frozen desserts ( 21 CFR 135); as a preservative in artificially sweetened fruit jellies and preserves ( 21 CFR 150); and as an optional ingredient in canned artichokes and mushrooms ( 21 CFR 155.200). It is an inhibitor of enzymatic browning or as preservatives ( antioxidants) in a variety of foods and beverages including concentrated milk products, certain meat products, pickling brine for pork and beef cuts, baked goods, soft and hard candies, fats, and oils, gravies, breakfast cereals and processed fruits and vegetables ( FDA 1979).

Ascorbic acid is also approved by the U. S. Department of Agriculture ( USDA) as curing accelerators for pork and beef and comminuted meat products ( 9CFR 318.7 ( c) ( 4)) ( FDA 1979). It is also used as a dietary supplement in animal feed ( SIDS 2003).

Acorbic acid is included on the Agency's list of chemicals included in the High Production Volume ( HPV) Challenge Program. HPV chemicals are those that are manufactured or imported into the United States in volumes greater than one million pounds per year. There are approximately 3,000 HPV chemicals that are produced or imported into the United States. The HPV Challenge Program is a voluntary partnership between industry, environmental groups, and the EPA which invites chemical manufacturers and importers to provide basic hazard data on the HPV chemicals they produce/ import. The goal of this program is to facilitate the public's rightto know about the potential hazards of chemicals found in their environment, their homes, their workplace, and in consumer products.

Ascorbyl palmitate: Ascorbyl palmitate is also classified as a GRAS substance by FDA as a food preservative ( 21 CFR 182.3149). It is a natural and synthetic food antioxidant that prevents rancidity and the browning of cut apples. In addition to its use as a food preservative, it Page 6 of 16 is an antioxidant in pharmaceuticals, a source of vitamin C, a stabilizer and emulsifier, and is used in medications ( Toxnet 2003). Ascorbyl palmitate is a common ingredient of over 500 cosmetic formulations, where it serves as an antioxidant. It is used at concentrations between 0.01 and 0.2% in these products ( CIR 1997).

Table 2: Use Pattern ( FDA GRAS)

Chemical GRAS Citation GRAS Uses ascorbyl palmitate 21 CFR 182.3149 preservative in foods ascorbic acid 21 CFR 182.3013 preservative in foods ascorbic acid 21 CFR 182.5013 nutrient and/ or dietary supplement III. Physical/ Chemical Properties:

The physical/ chemical properties of ascorbic acid and ascorbyl palmitate are shown on Table 3.

Table 3 Physical/ Chemical Properties Parameter Ascorbic Acid Ascorbyl Palmitate Molecular formula C6H8O6 C22H38O7 Melting point 190 192 C 116 C Solubility in water ( mg/ L) 0.33; freely soluble at 20oC 0.06; slightly soluble Molecular Weight 176.12 414.54 Physical state colorless crystals or white or yellowish white crystalline powder white or yellowish white powder Log Kow  1.85, experimental 6, experimental Vapor pressure ( mmHg) 1.79E 10 4.5E 17, experimental ( 25o C)

Henry's Law constant ( atmm3 mole) 4.07E 08 4.3E 17, experimental Koc 10 247 ( 25o C)

LogBCF 0.5 2.73, estimated Page 7 of 16 Ascorbic Acid Ascorbyl Palmitate IV. Hazard Assessment:

The key toxicological data in the following sections were obtained from ToxNet ( www. toxnet. nlm. nih. gov) and other websites, such as FirstGov ( www. firstgov. gov), as well as from the Cosmetic Ingredient Review ( CIR) safety assessment, FDA GRAS assessments, Food and Agriculture Organization of the World Health Organization ( FAO/ WHO) evaluations, and Structure Activity Relationship ( SAR) assessments.

Ascorbic palmitate is an ester of ascorbic acid, having greater fat solubility because of the long chain fatty acid ( palmitic acid). It is readily metabolized to ascorbic acid in the gastrointestinal tract, where it becomes active as Vitamin C ( FDA 1979). The FDA concluded that ascorbyl palmitate has vitamin C activity that is nearly equivalent to that of L ascorbic acid, the most potent of four ascorbic acid stereoisomers ( FDA 1979).

In the sections below, the available toxicological data for ascorbyl palmitate and ascorbic acid via the oral, dermal and/ or inhalation routes of exposure are summarized.

A. Toxicological data available for ascorbyl palmitate:

As noted previously, ascorbyl palmitate is classified by FDA as a GRAS substance as a preservative in foods ( 21 CFR 182.3149). It also has extensive use in cosmetics. A Cosmetic Ingredient Review ( CIR) safety assessment of ascorbyl palmitate reviewed acute oral, dermal, skin irritation, chronic, carcinogenicity, and mutagenicity studies. This expert panel concluded that it is " safe for use as cosmetic ingredients in the present practices of use." The use concentration of the ascorbyl palmitate in cosmetic products varies from 0.01 to 0.2 percent ( CIR 1997). 1 There are differences in dose estimates for this study. EPA has estimated 0.05%, 0.25% and 5% to be equivalent to doses of 71, 357 and 7142 mg/ kg/ day, respectively based on the following equation: mg/ kg food* kg food/ day * 1/ body wt ( kg) = mg/ kg/ day where 0.25% = 2500 mg/ kg, and kg food/ day = 0.05 and body weight for rats= 0.35 kg. WHO 1974 estimated that 0.25% was equivalent to 125 mg/ kg/ day. CIR 1997 estimated 0.05% and 0.25% were equivalent to 424 and 1060 mg/ kg/ day. FDA 1979 estimated that 0.25% ascorbyl palmitate is equivalent to about 53 mg/ kg ascorbic acid.

Page 8 of 16 The FDA evaluated the toxicological data for ascorbic acid and ascorbyl palmitate ( FDA 1979) and concluded " there is no evidence in the available information on L ascorbic acid, sodium L ascorbate, calcium L ascorbate, ascorbyl palmitate ( palmitoyl L ascorbate), ... that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used as food ingredients at levels that are now current or that might reasonably be expected in the future."

The Joint FAO/ WHO Expert Committee on food additives ( 1974) has evaluated ascorbyl palmitate and estimated an acceptable daily intake ( ADI) for man of between 0 1.25 mg/ kg. The ADI was based on an evaluation of several animal toxicity studies, and a no observed adverse effect level of 2500 ppm ( 0.25% diet).

Ascorbyl palmitate has a low order of acute oral and dermal toxicity in animal studies. In rats, the lowest acute effect level was 2500 mg/ kg/ day, which caused a decrease in body weight ( FDA 1995 as cited in CIR 1997). The acute oral LD 50 for a 33% suspension of ascorbyl palmitate in mice is 2 g/ kg. The acute dermal LD 50 in guinea pigs was > 3 g/ kg ( SCC 1993 as cited in CIR 1997). Ascorbyl palmitate ( 10%) was not irritating to the intact skin of albino rabbits, nor did it not cause eye irritation in albino rabbits ( CIR 1997). In clinical studies to assess cosmetic safety, ascorbyl palmitate did not cause dermal irritation or sensitization ( CIR 1997).

Ascorbyl palmitate penetrates the skin readily. When applied topically to guinea pigs, ascorbyl palmitate penetrated the skin barrier so that ascorbic acid content in skin, liver and blood increased by 8, 7 and 4 fold, respectively compared to controls ( Koroleva et al. 1981 as cited in CIR 1997).

There are a few longer term animal toxicological studies available for ascorbyl palmitate. In a nine month and two year study conducted by the same researchers, rats ( n= 10/ group) were fed heat treated lard containing dietary concentrations of 2 or 5% L ascorbyl palmitate ( 0.05% or 0.25% of the total diet) 1. In the nine month study, growth rate was significantly retarded at the 5% level, and two of the ten rats had numerous bladder stones and hyperplasia of the bladder epithelium. Another rat in this group had an inflammatory condition in the kidney. There was a slight retardation of growth in the 2% dietary group, but there were no significant differences for mortality or histopathology ( Fitzhugh and Nelson 1946 as cited in FAO/ WHO 1974). In the two year study, however, no adverse effects were noted for growth rate, mortality, and pathological examination ( Fitzhugh and Nelson 1946 as cited in FAO/ WHO 1974 and FDA 1979, SCC 1993 as cited in CIR 1997). The Joint FAO/ WHO Expert Committee concluded that the bladder stone formation noted in this study is not relevant for humans. Page 9 of 16 In a study to evaluate the carcinogenic potential of ascorbyl palmitate, mice were given dietary concentrations of 0 or 2% ascorbyl palmitate for two weeks, and then given azoxymethanol ( which induces the formation of focal areas of dysplasia ( FAD)) or saline. Ascorbyl palmitate did not produce signs of toxicity or effect body weight. No focal areas of dysplasia were observed in control mice or those fed ascorbyl palmitate ( Huang et al. 1992 as cited in CIR 1997).

Ascorbyl palmitate was not mutagenic in the Ames assay using S. typhimurium ( Ames test) and E. Coli. ( tryptophan reversion assay ) ( Prival et al. 1991 as cited in CIR 1997).

Beneficial Effects: Ascorbyl palmitate has been reported to have beneficial pharmacological effects. It appeared to prevent liver damage induced by acetaminophen in mice, by removing the reactive acetaminophen metabolite and by having a sparing action on reduced hepatic glutathione ( Jonker et al. 1988 as cited in CIR 1997). Small topical doses of ascorbyl palmitate inhibited by 91% of tumors in previously initiated mice, It also inhibited 12 Otetradecanoylphorbol 13 acetate ( TPA) induced ornithine decarboxylase activity, tumor production and DNA synthesis in mouse epithelial cells ( Smart et al. 1987 as cited in CIR 1997).

B. Ascorbic Acid Ascorbic acid, or vitamin C, is a naturally occurring, essential nutrient present in many edible plants, especially rapidly growing leafy vegetables, fruits, tomatoes and potatoes ( FDA 1979). It is synthesized in most plants and by many animals, but not by man, primates, and certain species such as the fruit bat and guinea pig. Species that do not naturally synthesize ascorbic acid must obtain it from the diet ( SIDS 2003). The average per capita consumption in the U. S. has been estimated to be 213 mg/ day for individuals 2 years of age and older ( FDA 1979). The total body store of ascorbic acid in a healthy human adult is estimated to be about 1.5 g ( or approximately 21 mg/ kg for a 70 kg individual). The U. S. Recommended Daily Allowance ( RDA) is 60 mg/ day for adults and children > 4 years of age ( Rumack 2003 as cited in Toxnet 2003). Some scientists have concluded that oral doses up to 10 g/ day ascorbic acid do not constitute a health risk ( Counsell and Hornig 1981 as cited in SIDS 2003). Three individuals administered a 1 g daily supplement of ascorbic acid for 3 months did not experience harmful effects ( Lowry et al. 1952 as cited in FDA 1979). Individuals occupationally exposed to up to 10 mg/ m3 ascorbic acid ( 8 hour time weighted average) did not exhibit any adverse health effects ( SIDS 2003).

Ascorbic acid is essential for the proper functioning of all cellular units in higher plants and animals, and in the synthesis of collagen. A severe deficiency of ascorbic acid causes scurvy ( when the body reservoir falls below 300 mg). This is characterized by lassitude, joint tenderness, swollen and inflamed gums, anemia, capillary hemorrhages, failure of wounds to heal, and failure of the cartilage, bone, and dentine to develop normally. It has several biochemical roles, including acting as a reducing agent, promoting iron absorption, and breaking down cholesterol to bile acids ( FDA 1979). Page 10 of 16 As noted previously, ascorbic acid is classified by the FDA as a GRAS substance. It has a history of safe use as natural components of many foods, as direct food additives, and as cosmetic ingredients. The FDA evaluated the toxicological data for ascorbic acid and ascorbyl palmitate ( FDA 1979) and concluded " there is no evidence in the available information on L ascorbic acid, sodium L ascorbate, calcium L ascorbate, ascorbyl palmitate ( palmitoyl L ascorbate), ... that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used as food ingredients at levels that are now current or that might reasonably be expected in the future."

Ascorbic acid is practically non toxic based on acute oral toxicity studies in rats, mice, guinea pigs, and dogs ( LD 50 > 5 g/ kg) ( FDA 1979, SIDS 2003). Subchronic oral toxicity data for several different animal species also indicate its low toxicity; the mouse 10 day LD 50 is 8021 mg/ kg, the rat 6 day LD 50 is > 6500 mg/ kg, the guinea pig 6 day LD 50 is > 8900 mg/ kg, and the dog 7 day LD 50 is 100 mg/ kg ( FDA 1979). L Ascorbic acid did not cause dermal irritation in rabbits when applied to the intact and abraded skin under semi occlusive conditions for 4 hours. It is non irritating to the rabbit eye ( Roche Research Report as cited in SIDS 2003). Ascorbic acid ( 30% aqueous solution) did not produce dermal sensitization in guinea pigs ( SCC 1993 as cited in CIR 1997).

No harmful effects were noted in rats following the oral administration of 6.5 g/ kg over a 10 week period. However, daily doses of 27.3 g/ kg were toxic; the mortality rate rose to 77% within 4 weeks. The investigators concluded that the maximum nontoxic dose in the rat is 10 g/ kg ( FDA 1979). In another short term study, weight gain in young rats was reduced as doses above 1 g/ kg ascorbic acid. A laxative effect was noted in rats that received 10 g/ kg, and two of six rats in this group died.

In a developmental study, pregnant rats ( n= 19 27) were given 150, 250, 500 and 1000 mg/ kg/ day ascorbic acid from gestational days 6 15 in the first trial and from postconception days 0 21 for the second trial. Mice ( n= 19 27) also received oral daily doses of 250, 500, or 1000 mg/ kg ascorbic acid from days 6 15 of pregnancy. There were no indications of parental toxicity, or teratogenic or fetotoxic effects. There was no apparent effect on the embryonic and postpartum development of the young or on breeding behavior, pregnancy, parturition, and lactation capacity of the dams ( Frohberg et al. 1973 as cited in FDA 1979 and SIDS 2003). In other developmental studies, ascorbic acid was given at doses up to 520 mg/ kg to pregnant mice and up to 550 mg/ kg to pregnant rats for 10 consecutive days starting on day 6. No discernable effects were noted on maternal or fetal survival, or soft tissue or skeletal abnormalities ( Food and Drug Research Laboratories 1975 as cited in FDA 1979).

In a reproductive study with guinea pigs, initiation and maintenance of pregnancy was less successful in animals given 4 mg/ kg ascorbic acid compared to those given 10 and 100 mg/ kg. The offspring of the parent animals given 100 mg/ kg had a reduced survival rate ( Steel 1969, as cited in FDA 1979). In another study, diets up to 500 mg/ kg ascorbic acid fed to guinea pigs did not adversely affect the number and size of the litters or any other aspect of fertility ( Korner and 2Estimated doses based on the following: mg/ kg food* kg food/ day * 1/ body wt ( kg) = mg/ kg/ day where 2.5% = 25,000 mg/ kg, and kg food/ day = 0.05 ( rats) and 0.13 ( mice) and body weight of 0.35 kg ( rats) and 0.03 kg ( mice).

Page 11 of 16 Weber 1972 as cited in FDA 1979). In a third reproductive study, guinea pigs were fed 1.5, 4 or 100 mg ascorbic acid for three generations. The high dose group had the most litters and fewest abortions, but there were no differences among the groups in the number of newborns or viable young ( Rivers 1974 as cited in FDA 1979).

In a 10 month rat study, 20 g/ kg L ascorbic acid increased urinary oxalate, calcium and iron, but had no significant effect on calcification in the kidneys nor did it affect the kidney calcium concentration. There were no other adverse effects reported ( Keith et al. 1974 as cited in SIDS 2003).

In a 2 year chronic study, groups of 26/ sex rats were fed doses of 0, 1, 1.5 or 2 g/ kg/ day ascorbic acid. There were no treatment related effects for body weight, mortality, general physical condition, blood and urine chemistry, liver and kidney function tests, or macro and micropathological appearance of the various organs and tissues examined ( FDA 1979).

In a more recent 2 year chronic study, rats and mice ( n= 50/ sex/ dose) fed dietary concentrations of 2.5 and 5% ( equivalent to approximately 3.6 and 7.1 g/ kg/ day for rats, and 108 and 217 g/ kg/ day for mice, respectively) 2 did not exhibit treatment related clinical signs other than slight lowering of mean body weight in female mice and rats. There was no evidence of carcinogenicity ( Douglas et al. 1984 as cited in SIDS 2003).

The weight of evidence indicates that L ascorbic acid does not produce gene mutation in Samonella typhimurium or Saccharomyces cerevisiae, nor in mammalian cells using the mouse lymphoma assay ( L5178Y TK +/ cell). L Ascorbic acid has no structural alerts for alkylation. Positive results were consistently obtained in vitro assays for sister chromatid exchange ( SCE) and unscheduled DNA synthesis ( UDS) induction with and without metabolic activation, indicating the ability to produce DNA damage under certain conditions. However, negative results were obtained in in vivo assays, using high dose levels, for the induction of micronclei and SCEs in bone marrow chinese hamsters. Although activity was seen in in vitro assays for genotoxicity ( UDS and SCEs) the mechanism involved would suggest that activity was unlikely to be seen in vivo. It has been postulated that the mammalian organism is protected against damage by peroxide radicals or that such radicals are not formed by L ascorbic acid in body fluid. Thus, L ascorbic acid is not an in vivo mutagen ( SIDS 2003).

In animals, such as guinea pigs and rats, the major product of metabolism is carbon dioxide, which is excreted in the lungs. Urinary and fecal excretion contribute only a minor part. The metabolism of L ascorbic acid in the monkey and man are similar. Half lives are substantially prolonged when lower amounts of L ascorbic acid are ingested. The percentage of unmetabolized L ascorbic acid excreted in urine increases with the dietary intake. In the monkey Page 12 of 16 and man, L ascorbic acid is not primarily converted to carbon dioxide, but rather is excreted as ascorbate and oxalate in the urine ( SIDS 2003).

Beneficial Effects: Many studies suggest that substantial intakes of ascorbic acid generally diminish the toxicity of ( i. e., provide protection against) the excesses of several heavy metals, including lead, mercury, vanadium and cadmium ( FDA 1979). Ascorbic acid has also been shown to promote the absorption of iron in individuals ( FDA 1979). In addition, topical application of 10% vitamin C to pigs protected the skin against ultraviolet B ( UVB) damage ( CIR 1997). It has been suggested that ascorbic acid is useful in the prevention and treatment of the common cold and other disorders ( FDA 1979).

D. Special Considerations for Infants and Children At this time, there is no concern for potential sensitivity to infants and children. A safety factor analysis has not been used to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

V. Exposure Assessment:

The most significant source of exposure to ascorbic acid is the diet. L Ascorbic acid is naturally occurring in many foodstuffs at levels ranging from 40 mg/ kg in apples to 20,000 mg/ kg in acerola cherries. Parsley, green peppers, lemons, oranges, tomatoes, potatoes and mushrooms are other sources of L ascorbic acid. Other significant sources of exposure include the many FDA approved uses as food additives, in dietary supplements ( as a source of Vitamin C), and cosmetic products. As noted previously, ascorbyl palmitate is a common ingredient of over 500 cosmetic formulations, where is serves as an antioxidant. It is used at concentrations between 0.01 and 0.2% in these products ( CIR 1997). For example, it is present at 0.02% in body cleansers, 0.02% in cologne, at 0.01% in body oil, and at 0.2% in eye cream.

The total body store of ascorbic acid in a healthy human adult is estimated to be about 1.5 g ( or approximately 21 mg/ kg for a 70 kg individual). The U. S. RDA is 60 mg/ day for adults and children > 4 years of age ( Rumack 2003 as cited in Toxnet 2003).

Residues from the pesticide uses of ascorbic acid and ascorbyl palmitate are not likely to exceed the naturally occurring levels of ascorbic acid in commonly eaten foods. In addition, the use of these compounds in pesticide products is expected to result in much lower exposure than the FDA regulated use of these compounds, as well as lower exposure than the use in cosmetics. For example, cosmetic products containing ascorbyl palmitate may be used from once a week up to several times a day, and may remain in contact with body surfaces for a few minutes ( hair bleachers, cleansing creams) to as long as a few days ( moisturizing creams) ( CIR 1997). Both ascorbic and ascorbyl palmitate are of low toxicity to humans, and there is no reason to expect that reasonable use will constitute any significant hazard. Therefore, a quantitative screeninglevel exposure assessment has not been conducted. Page 13 of 16 VI. Risk Characterization:

Ascorbyl palmitate is readily metabolized to ascorbic acid in the human body, and ascorbic acid, is a significant part of the normal daily diet. As previously discussed in this document, there are many FDA approved uses. Residues from the pesticide uses of ascorbyl palmitate and ascorbic acid are not likely to exceed the naturally occurring levels in commonly eaten foods, or the current exposures from FDA approved uses.

Taking into consideration all available information on ascorbyl palmitate and ascorbic acid, including their low acute toxicity via oral and dermal routes, FDA's designation of both compounds as GRAS, their presence in food products, food additives, and cosmetics, as well as the significant contribution of ascorbic acid ( vitamin C) in the diet, the uses of these compounds as inert ingredients in pesticide products are unlikely to pose a significant hazard to the general public or any population subgroup. Exposures from the aforementioned uses are expected to result in human exposure below any dose level that could possibly produce an adverse effect. As a result, AD is conducting a qualitative approach to assessing human health risks from exposure to ascorbyl palmitate and ascorbic acid.

As noted previously, ascorbic acid is included on the Agency's list of chemicals included in the High Production Volume ( HPV) Challenge Program. HPV chemicals are those that are manufactured or imported into the United States in volumes greater than one million pounds per year. There are approximately 3,000 HPV chemicals that are produced or imported into the United States. The HPV Challenge Program is a voluntary partnership between industry, environmental groups, and the EPA which invites chemical manufacturers and importers to provide basic hazard data on the HPV chemicals they produce/ import. The goal of this program is to facilitate the public's right to know about the potential hazards of chemicals found in their environment, their homes, their workplace, and in consumer products. Based on the available toxicity data for ascorbic acid, the Agency feels confident in proceeding with this tolerance reassessment decision. Any submission of data for ascorbic acid as part of the HPV Challenge Program may, in the future, be used by OPP to revise or update their tolerance reassessment decision for ascorbic acid as deemed necessary and appropriate.

VII. Environmental Fate/ Ecotoxicity/ Drinking Water Considerations:

Environmental Fate Characterization Ascorbyl Palmitate. Based on its physical/ chemical properties, ascorbyl palmitate is slightly soluble in water and is expected to have moderate to strong sorption to soils and sediments. Therefore, there is limited potential to reach surface water by dissolved runoff and/ or leach to ground water ( EPA 1995). Volatilization from soils and water is not likely to be an important transport process in the environment based on ascorbyl palmitate's low vapor pressure and Henry's law constant. Although there is potential to bioaccumulate ( log Kow 6), bioavailability is offset by rapid primary biodegradation ( hours to days). Page 14 of 16 Ascorbic Acid. Ascorbic acid is freely soluble in water. L Ascorbic acid degraded 11% after 7 days and 50% after 28 days. Degradation was more rapid in the presence of activated sludge, where L ascorbic acid ( 733 mg/ L) biodegraded by 97% after 5 days and completely after 15 days. There is no evidence that ascorbic acid bioaccumulates in animals or man. There was no bioaccumulation in guinea pigs fed 86 g/ kg ascorbic acid for 275 days ( SIDS 2003).

Ecotoxicity and Ecological Risk Characterization Ascorbyl Palmitate. The limited ecotoxicity data show that ascorbyl palmitate is moderately to fish ( 96 hour LC 50 = 0.45 1.2 ppm), and highly toxic to Daphnia magna ( 48 hour EC 50 = 0.07 0.36 ppm), and green algae ( 96 hr EC 50 = 0.04 ppm) ( EPA 2002, EFED memo). The chronic toxicity estimate for fish is 0.003 ppm. However, the water solubility of 0.06 ppm is less than the fish 96 hr LC 50 . Considering this factor and in combination with the very low mobility and bioavailability, there is less potential for acute risk to fish than for the free acid groups. Aquatic invertebrates will be at a greater acute risk than fish, nevertheless the greatly reduced bioavailability and fairly rapid microbial degradation  approximately 4 days for primary degradation  will not likely result in significant risk ( EPA 2002, EFED memo).

A Structure Activity Relationship ( SAR) assessment for ascorbyl palmitate predicted that this compound may be more toxic than ascorbic acid. However, based on its physical/ chemical properties, ascorbyl palmitate is expected to have moderate to strong sorption to soils and sediments, and negligible migration to groundwater ( EPA 1995, EPA 2002, EFED memo).

Ascorbic Acid. L Ascorbic acid is naturally present in all aquatic and biotic systems; it is essential to animal life and is naturally synthesized by most plants, but not invertebrates, or fish. It is essential for normal growth and development, and thus is present in the majority of living organisms. L Ascorbic acid levels in plants are typically in the range of 200 500 mg/ kg ( SIDS 2003). L ascorbic acid is widely used as a dietary supplement in fish and chicken reared for food production. No adverse effects were noted in developing hatchlings of trout ( n= 300) and catfish ( n= 60) fed dietary levels as high as 10 g/ kg and 5 g/ kg for 16 and 21 weeks, respectively ( Lann et al. 1985, Mayer et al. 1978, respectively as cited in SIDS 2003). These concentrations are approximately 100 times the normal requirement for healthy growth and wound healing in trout and catfish, which are 100 mg/ kg and 60 mg/ kg, respectively ( Vitamin Tolerance of Animals, National Academy Press 1987 as cited in SIDS 2003). In chickens, dietary concentrations up to 3.3 g/ kg for up to 30 weeks had no adverse effects ( Chen and Nockels 1973 as cited in SIDS 2003).

L Ascorbic acid has low toxicity to rainbow trout. In a 96 hour acute toxicity study, rainbow trout ( n= 10/ group) were exposed to L ascorbic acid concentrations of 0, 400, 600, 800, 1,000 and 1,200 mg/ L at natural pH. In a separate study, the same concentrations ( except 1,200 mg/ L) were tested and the pH was adjusted to 7.5 ± 0.5 using sodium hydroxide. The LC 50 was 1,020 mg/ L at natural pH; there were no deaths at 800 mg/ L and 10/ 10 deaths at 1,200 mg/ L. At pH of 7.5 ± 0.5, there were no deaths at 1,000 mg/ L ( Schlienger and Groner as cited in SIDS 2003). Page 15 of 16 Drinking Water Considerations:

There are no federal drinking water standards for ascorbic acid or ascorbyl palmitate.

VIII. Cumulative Exposure:

Section 408( b)( 2)( D)( v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity."

EPA does not have, at this time, available data to determine whether ascorbic acid and ascorbyl palmitate assessed in this document have a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to ascorbic acid and ascorbyl palmitate and any other substances and ascorbic acid and ascorbyl palmitate do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that ascorbic acid and ascorbyl palmitate have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

References:

( Note to the Reader: MRID ( Master Record Identification) Numbers were added to the references on October 17, 2003. These numbers were not available at the time of document signature. No other changes were made to the document.)

Cosmetic Ingredient Review ( CIR). 1997. Final Report of the Safety Assessment of Ascorbyl palmitate, ascorbyl dipalmitate, ascorbyl stearate, erythorbic acid and sodium erythorbate. Washington DC. April. ( Also published in the International Journal of Toxicology, Vol 18( 3), 1999).

FAO/ WHO 1974. Seventeenth Report of the Joint FAO/ WHO Expert Committee on Food Additives. Ascorbyl Palmitate and Stearate. World Health Organization Technical Report Ser. No. 539; FAO Nutrition meetings Report Series No. 53.

Food and Drug Administration ( FDA). 1979. Evaluation of the Health Aspects of Ascorbic Acid, Sodium Ascorbate, Calcium Ascorbate, Erythorbic Acid, Sodium Erythorbate, and Ascorbyl Palmitate as Food Ingredients. Bureau of Foods, FDA, Department of Health, Education and Welfare. Washington, D. C. Prepared by Life Sciences Research Office, Page 16 of 16 Federation of American Societies for Experimental Biology. Bethesda MD. ( MRID No. 46069101)

SIDS Data Set on L Ascorbic Acid ( Vitamin C). 2003. http:// irptc. unep. ch/ irptc/ sids/ volume4/ part1/ ascorbic/ sidsdata. html.

TOXNET 2003. Hazardous Substances Databank ( HSDB). On line Scientific Search Engine, National Library of Medicine, National Institute of Health. Http:// www. toxnet. nlm. nih. gov. Search term: Ascorbyl Palmitate U. S. Environmental Protection Agency ( EPA). Structure Activity Relationship ( SAR). 1995. Structure Activity Team Report. OPPT. Ascorbyl palmitate.

U. S. Environmental Protection Agency ( EPA). 2002. " Tolerance Review of Compounds Known as Fatty Acids, Fatty Acid Salts, and Fatty Acid Esters, and Fatty Acid Derivatives Classified as Inert Ingredients in Terrestrial and/ or Aquatic Agricultural and Non Agricultural Uses". Memorandum from S. C. Terms/ H. Craven, Environmental Fate and Effects Division ( EFED) to M. Perry, Special Review and Reregistration Division ( SRRD). May 15, 2002.


[Federal Register: March 24, 2010 (Volume 75, Number 56)]
[Notices]
[Page 14229-14231]
[DOCID:fr24mr10-135]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61736; File No. SR-NASDAQ-2010-038]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change by The NASDAQ Stock Market LLC
To Permit the Concurrent Listing of $3.50 and $4 Strikes for Classes
Participating in the $0.50 Strike Program and the $1 Strike Program

March 18, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'')\1\, and Rule 19b-4\2\ thereunder, notice is hereby given that
on March 16, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with
the Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I, II, and III, below, which
Items have been prepared by NASDAQ. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASDAQ is filing with the Securities and Exchange Commission
(``SEC'' or ``Commission'') a proposal for the NASDAQ Options Market
(``NOM'' or ``Exchange'') to amend Chapter IV, Section 6 (Series of
Options Contracts Open for Trading) to permit the concurrent listing of
$3.50 and $4 strikes for classes that participate in both the $0.50
Strike Price Program (``$0.50 Strike Program'')\3\ and the $1 Strike
Price Program (``$1 Strike Program'').\4\
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    \3\ The $0.50 Strike Program was initiated in an immediately
effective filing on November 6, 2009. See Securities Exchange Act
Release No. 60952 (November 6, 2009), 74 FR 59277 (November 17,
2009) (SR-NASDAQ-2009-099) (notice of filing and immediate
effectiveness).
    \4\ The $1 Strike Program was initially approved as a pilot on
March 12, 2008. See Securities Exchange Act Release No. 57478 (March
12, 2008), 73 FR 14521(March 18, 2008) (SR-NASDAQ-2007-004 and SR-
NASDAQ-2007-080) (order approving). The program was subsequently
made permanent and expanded. See Securities Exchange Act Release
Nos. 58093 (July 3, 2008), 73 FR 39756 (July 10, 2008) (SR-NASDAQ-
2008-057) (notice of filing and immediate effectiveness); 59588
(March 17, 2009), 74 FR 12410 (March 24, 2009) (SR-NASDAQ-2009-025)
(notice of filing and immediate effectiveness); and 61347 (January
13, 2010), 75 FR 3513 (January 21, 2010) (SR-NASDAQ-2010-003)
(notice of filing and immediate effectiveness).
---------------------------------------------------------------------------

    The Exchange requests that the Commission waive the 30-day
operative delay period contained in Exchange Act Rule 19b-
4(f)(6)(iii).\5\
---------------------------------------------------------------------------

    \5\ 17 CFR 240.19b-4(f)(6)(iii).
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    The text of the proposed rule change is available from NASDAQ's Web
site at http://nasdaq.cchwallstreet.com/Filings/, at NASDAQ's principal
office, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of and basis for the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this proposal is to amend Chapter IV, Section 6 to
permit the concurrent listing of $3.50 and $4 strikes for classes that
participate in both the $0.50 Strike Program and the $1 Strike Program.
    The Exchange recently implemented a rule change that permits strike
price intervals of $0.50 for options on stocks trading at or below
$3.00 pursuant to the $0.50 Strike Program.\6\ As part of the filing to
establish the $0.50 Strike Program, the Exchange contemplated that a
class may be selected to

participate in both the $0.50 Strike Program and the $1 Strike Program.
Under the $1 Strike Program, new series with $1 intervals are not
permitted to be listed within $0.50 of an existing $2.50 strike price
in the same series, except that strike prices of $2 and $3 are
permitted to be listed within $0.50 of a $2.50 strike price for classes
also selected to participate in the $0.50 Strike Program.\7\ Under the
Exchange's current Chapter IV, Section 6, for classes selected to
participate in both the $0.50 Strike Program and the $1 Strike Program,
the Exchange may either: (a) List a $3.50 strike but not list a $4
strike; or (b) list a $4 strike but not list a $3.50 strike. For
example, if a $3.50 strike for an option class in both the $0.50 and $1
Strike Programs was listed, the next highest permissible strike price
would be $5.00. Alternatively, if a $4 strike was listed, the next
lowest permissible strike price would be $3.00. The intent of the $0.50
Strike Program was to expand the ability of investors to hedge risks
associated with stocks trading at or under $3 and to provide finer
intervals of $0.50, beginning at $1 up to $3.50. As a result, the
Exchange believes that the current filing is consistent with the
purpose of the $0.50 Strike Program and will permit the Exchange to
fill in any existing gaps resulting from having to choose whether to
list a $3.50 or $4 strike for options classes in both the $0.50 and $1
Strike Programs.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 60952 (November 6,
2009), 74 FR 59277 (November 17, 2009) (SR-NASDAQ-2009-099) (notice
of filing and immediate effectiveness); and Chapter IV, Section 6,
Supplementary Material .05 to Section 6.
    \7\ See Chapter IV, Section 6, Supplementary Material .02(b) to
Section 6.
---------------------------------------------------------------------------

    Therefore, the Exchange is submitting the current filing to permit
the listing of concurrent $3.50 and $4 strikes for classes that are
selected to participate in both the $0.50 Strike Program and the $1
Strike Program. To effect this change, the Exchange is proposing to
amend Chapter IV, Section 6, Supplementary Material .02(b) to Section 6
by adding $4 to the strike prices of $2 and $3 currently permitted if a
class participates in both the $0.50 Strike Program and the $1 Strike
Program.
    The Exchange is also proposing to amend the current rule text to
delete references to ``$2.50 strike prices'' (and the example utilizing
$2.50 strike prices) and to replace those references with broader
language, e.g., ``existing strike prices.''
    Finally, the Exchange is proposing technical, housekeeping rule
changes to Chapter IV, Section 2, Supplementary Material .02 to Section
6 to conform formatting and punctuation and to Chapter IV, Section 6,
Supplementary Material .09 to Section 6 to ensure consistency of
internal numbering.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \8\ in general, and furthers the objectives of Section
6(b)(5) of the Act \9\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanisms of a free and open
market and a national market system, by permitting the Exchange to list
more granular strikes on options overlying lower priced securities,
which the Exchange believes will provide investors with greater
flexibility by allowing them to establish positions that are better
tailored to meet their investment objectives.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) \10\ of the Act and Rule 19b-
4(f)(6) \11\ thereunder. The Exchange provided the Commission with
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at least
five business days prior to the date of filing the proposed rule
change.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay to permit the Exchange to compete with other exchanges
whose rules permit concurrent listing of $3.50 and $4 strikes for
classes similarly participating in both a $0.50 strike program and a $1
strike program. The Commission finds that waiver of the operative delay
is consistent with the protection of investors and the public interest
because such waiver will encourage fair competition among the
exchanges. Therefore, the Commission designates the proposal operative
upon filing.\12\
---------------------------------------------------------------------------

    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2010-038 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2010-038. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the

Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street, NE., Washington, DC 20549, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of the
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2010-038 and should be submitted on or before
April 14, 2010.

    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,
Deputy Secretary.
[FR Doc. 2010-6515 Filed 3-23-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 29, 2006 (Volume 71, Number 250)]
[Notices]
[Page 78417-78418]
[DOCID:fr29de06-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER07-103-001]

LSP Oakland, LLC; Notice of Filing

December 22, 2006.
    Take notice that on December 20, 2006, LSP Oakland, LLC submitted
for filing a revision to Tariff Sheet No. 144 of its Reliability Must-
Run Agreement with the California Independent System Operator
Corporation.
    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, 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. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    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 online 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 e-mail
notification when a

document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 pm Eastern Time on January 10, 2007.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-22375 Filed 12-28-06; 8:45 am]

BILLING CODE 6717-01-P


September 17, 2010

MEMORANDUM

TO: 	Air Docket EPA-HQ-OAR-2010-0133

	SUBJECT:	Docket Key for Canola-Based Biodiesel Lifecycle GHG Results

To facilitate docket navigation, EPA is providing the following directory to lifecycle analysis (LCA) results available on the rulemaking docket.  The documents listed below, as well as additional RFS2-related information, are available at www.regulations.gov under Docket ID: EPA-HQ-OAR-2010-0133.

Subject Heading	Docket ID Number	Description / Scenario

Lifecycle GHG Inputs / Results

	EPA-HQ-OAR-2010-0133-0049	Memorandum describing inputs and spreadsheets that calculate lifecycle GHG emissions reductions

	EPA-HQ-OAR-2010-0133-0049.1	Memorandum describing information on the key input assumptions used for modeling the canola oil biodiesel lifecycle pathway

	EPA-HQ-OAR-2010-0133-0049.2	Spreadsheet integrating results from all stages of the fuel lifecycle to calculate canola-based biodiesel lifecycle GHG emissions

	EPA-HQ-OAR-2010-0133-0049.3	Spreadsheet calculating GHG emissions per unit of canola-based biodiesel.  The only piece of the lifecycle analysis not calculated in this spreadsheet is the emissions from international land use change.

	EPA-HQ-OAR-2010-0133-0049.4	This spreadsheet includes raw results from the FASOM model

	EPA-HQ-OAR-2010-0133-0049.5	Spreadsheet including results from the FASOM model converted into the format needed to calculate domestic agricultural sector and land use change GHG calculations

	EPA-HQ-OAR-2010-0133-0049.6	Spreadsheet including raw results from the FAPRI-CARD model for a canola oil biodiesel scenario

	EPA-HQ-OAR-2010-0133-0049.7	Spreadsheet including EPA’s calculations to convert the raw FAPRI-CARD model results data into differences between scenarios to determine biofuel-induced GHG emissions impacts

	EPA-HQ-OAR-2010-0133-0049.8	Excel-based model used to perform EPA’s stochastic analysis of international land use change GHG emissions impacts induced by canola-based biodiesel

	EPA-HQ-OAR-2010-0133-0049.9	Spreadsheet including data about agricultural fertilizer inputs in foreign countries

	EPA-HQ-OAR-2010-0133-0049.10	Spreadsheet including data about agricultural energy use in foreign countries

	EPA-HQ-OAR-2010-0133-0049.11	Spreadsheet including data about rice methane emissions in foreign countries

 PAGE

 PAGE   1


[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Page 31929]
[FR Doc No: 2016-11893]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP16-357-000 and PF15-31-000]

Columbia Gas Transmission, LLC; Notice of Application

    Take notice that on April 29, 2016, Columbia Gas Transmission, LLC
(Columbia Gas) 5151 San Felipe, Suite 2500, Houston, Texas 77056, filed
in Docket No. CP16-357-000 an application pursuant to sections 7(b) and
7(c) of the Natural Gas Act (NGA), and Part 157 of the Commission's
regulations requesting authorization to construct and operate the
Mountaineer XPress Project, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. The filing is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site web
at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions concerning this application may be directed to S.
Diane Neal, Assistant General Counsel, Columbia Gas Transmission, LLC,
5151 San Felipe, Suite 2500, Houston, Texas 77056, at<PHONE_NUMBER>.
    Specifically Columbia Gas proposes to: (i) Construct and operate
approximately 170.1 miles of various diameter pipeline, (ii) modify
threes existing compressor stations, (iii) construct and operate three
new compressor stations, (iv) and install various appurtenant and
auxiliary facilities, all located in either Marshall, Wetzel, Tyler,
Doddridge, Ritchie, Calhoun, Wirt, Roane, Jackson, Mason, Putnam,
Kanawha, Cabell, and Wayne Counties, West Virginia. The project will
provide approximately 2.7 million dekatherms per day of additional
capacity for firm transportation service. Columbia Gas is proposing
incremental rates for transportation service on the facilities proposed
for construction herein. The cost of the project will be approximately
$2.059 billion.
    On September 16, 2015 the Commission staff granted Columbia Gas'
request to utilize the Pre-Filing Process and assigned Docket No. PF15-
31-000 to staff activities involved in the Project. Now, as of the
filing of the April 29, 2016 application, the Pre-Filing Process for
this project has ended. From this time forward, this proceeding will be
conducted in Docket No. CP16-357-000, as noted in the caption of this
Notice.
    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit seven copies of filings made in the proceeding with the
Commission and must mail a copy to the applicant and to every other
party. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
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 7 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on June 3, 2016.

    Dated: May 13, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-11893 Filed 5-19-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: May 10, 2010 (Volume 75, Number 89)]
[Rules and Regulations]
[Page 25775-25778]
[DOCID:fr10my10-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2009-0573; FRL-9146-5]

Disapproval of State Implementation Plan Revisions, South Coast
Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing disapproval of a revision to the South Coast
Air Quality Management District (SCAQMD) portion of the California
State Implementation Plan (SIP). This action was proposed in the
Federal Register on September 8, 2009 and concerns volatile organic
compound (VOC) emissions from polymeric foam manufacturing operations.
Under authority of the Clean Air Act as amended in 1990 (CAA or the
Act), this action identifies several deficiencies in SCAQMD Rule 1175.

DATES: Effective Date: This rule is effective on June 9, 2010.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2009-0573 for
this action. The index to the docket is available electronically at
www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne
Street, San Francisco, California. While all documents in the docket
are listed in the index, some information may be publicly available
only at the hard copy location (e.g., copyrighted material), and some
may not be publicly available in either location (e.g., CBI). To
inspect the hard copy materials, please schedule an appointment during
normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Andrew Steckel, EPA Region IX, (415)
947-4115<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Statutory and Executive Order Reviews

I. Proposed Action

    On September 8, 2009 (74 FR 46044), EPA proposed to disapprove the
following rule that was submitted for incorporation into the California
SIP.

----------------------------------------------------------------------------------------------------------------
                                              Rule
               Local agency                  Number              Rule title               Adopted     Submitted
----------------------------------------------------------------------------------------------------------------
SCAQMD...................................       1175  Control of Emissions from the        09/07/07     03/07/08
                                                       Manufacturing of Polymeric
                                                       Cellular (Foam) Products.
----------------------------------------------------------------------------------------------------------------

    We proposed to disapprove this rule because some rule provisions do
not satisfy the requirements of section 110 and part D of the Act.
These provisions include the following:
    A. The rule must require demonstration, through source testing
approved in writing by the Executive Officer, that the systems and
techniques in place at a facility achieve 93% collection and reduction
of emissions for sources complying with paragraph (c)(4)(B)(iii).
    B. The rule must clarify that all operational techniques and
parameters needed to achieve 93% control to comply with paragraph
(c)(4)(B)(iii) must be clearly defined and enforceable through a
federally enforceable permit such as a Title V operating permit.\1\
Rule 1175 should also be revised where possible to identify these
parameters.
---------------------------------------------------------------------------

    \1\ SCAQMD implements a combined Title I preconstruction and
Title V operating permit program.

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

    C. The rule must clarify that all operational techniques and
parameters needed to achieve 90% collection and 95% destruction to
comply with paragraphs (c)(4)(B)(i) and (ii) must be clearly defined
and enforceable through a federally enforceable permit such as a Title
V operating permit. Rule 1175 should also be revised where possible to
identify these parameters.
    Our proposed action contains more information on the basis for this
rulemaking and on our evaluation of the submittal.

II. Public Comments and EPA Responses

    EPA's proposed action provided a 30-day public comment period.
During this period, we received comments from the following parties.
    A. Shawn Osler, Environmental Compliance Manager, Insulfoam LLC, to
Andrew Steckel, EPA, letter dated October 7, 2009.
    B. Laki Tisopulos, Assistant Deputy Executive Officer, SCAQMD, to
Andrew Steckel, EPA, letter dated October 8, 2009.
    The comments and our responses are summarized below.
    Comment #1: Insulfoam commented that EPA should reassess the
proposed disapproval because the identified rule deficiencies are
already adequately addressed by requirements in a Title V permit
reviewed by EPA for the only facility affected by EPA's proposed
disapproval of Rule 1175. Any changes to this permit would also require
EPA review.
    Response #1: This comment could be logically extended to suggest
that no industry-specific rules are needed in SIPs as long as the
state/local agency has an adequate permit program. However, EPA has
long interpreted CAA Section 110(a)(2)(A) to require enforceable
requirements in SIP-approved regulations, and not just rely on permits.
    Comment #2: EPA should also reassess the proposed disapproval
because recent SIP approvals within Region 9 indicate that EPA has not
required analogous provisions as a condition of approval for all
similar rules.
    Response #2: The primary provision at issue in SCAQMD Rule 1175
requires 93% emission capture and control. Other SIP-approved
stationary source rules that establish analogous emission capture and
control requirements generally require both: (a) An initial compliance
test to demonstrate the control efficiency, and (b) ongoing monitoring
to demonstrate that key parameters (e.g., temperature of afterburner)
are maintained consistent with the conditions demonstrated during the
successful source test. The deficiencies identified by EPA's proposed
disapproval are unusual because Rule 1175 fails to require either
initial compliance testing or sufficient ongoing monitoring. We also
note that the comment does not identify any specific inconsistent SIP
approvals.
    Comment #3: At a minimum, EPA should consider partial or
conditional approval of Rule 1175 instead of full disapproval.
    Response #3: Bethlehem Steel Corp. v. Gorsuch (742 F. Second 1028
Seventh Circuit, 1984) limits EPA's ability to publish partial
approvals. If we could partially approve Rule 1175, we would likely
need to exclude the new 93% compliance option that is the primary
subject of our proposed limited disapproval which would have the same
effect as our full disapproval action as proposed. See Response
7 below regarding conditional approvals.
    Comment #4: SCAQMD commented that the pre-September 7, 2007 version
of Rule 1175 has served as a model to the rest of the country and has
been approved into the SIP without any of the issues raised by EPA.
    Response #4: We agree with the comment and acknowledge SCAQMD's
leadership in regulating this industry. We note that: (a) The issues we
have identified as deficiencies are largely raised by the September 7,
2007 revisions; and (b) our disapproval of the September 7, 2007
version would retain the previous version in the SIP, which has served
as a model rule.
    Comment #5: The September 7, 2007 amendment further improves the
efficacy of the rule by providing the one block foam manufacturer in
South Coast with an environmentally superior alternative compliance
option.
    Response #5: The deficiencies identified in our proposed
disapproval largely address our concerns that the new alternative
compliance option, as described in the rule, is not adequately
enforceable.
    Comment #6: The revisions suggested by EPA are not necessary and of
limited usefulness at best because SCAQMD already includes permit
conditions establishing the required parameters and source testing as
EPA requested.
    Response #6: See Response 1.
    Comment #7: If EPA declines to fully approve the rule, SCAQMD
prefers a conditional approval pursuant to CAA Section 110(k)(4) in
lieu of the proposed disapproval.
    Response #7: The State has not fulfilled the requirements of CAA
Section 100(k)(4) for a conditional approval, which include a
commitment from the State to adopt specific enforceable measures by a
certain date.
    Comment #8: Prompt approval of Rule 1175 will expedite
implementation by the one affected facility of the environmentally
superior alternative compliance option provided in paragraph
(c)(4)(B)(iii).
    Response #8: While we are not opining on whether paragraph
(c)(4)(B)(iii) provides an environmentally superior alternative
compliance option, we do not believe that this and related paragraphs
in Rule 1175 are fully enforceable as discussed in our proposed action
and required by CAA Section 110(a).
    Comment #9: AQMD staff will be prepared to develop an
administrative amendment that would explicitly require source testing
and permits be obtained by any impacted facility.
    Response #9: We believe such a rule amendment would address the
deficiencies identified in our proposal and we look forward to working
with SCAQMD on specific rule text. See also Response 7 above.
    Comment #10: AQMD staff would object to the notion that specific
parameters be identified in the rule. To establish industry-wide
operational parameters within the rule is impractical and that level of
detail is best left to be identified during the permitting process.
    Response #10: We concur with this comment and believe it is
consistent with our proposed action.

III. EPA Action

    No comments were submitted that change our assessment of the rule
as described in our proposed action. Therefore, as authorized in
section 110(k)(3) of the Act, EPA is finalizing a full disapproval of
the submitted rule. This action retains the existing SIP rule in the
SIP. There are no sanction or FIP implications of this action pursuant
to CAA Sections 179 or 110(c), as this is not a required CAA submittal.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866, Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under the EO.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b).

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and small governmental
jurisdictions.
    This rule will not have a significant impact on a substantial
number of small entities because SIP disapprovals under section 110 and
subchapter I, part D of the Clean Air Act do not create any new
requirements but simply disapprove requirements that the State is
already imposing. Therefore, because the Federal SIP approval does not
create any new requirements, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
    Moreover, due to the nature of the Federal-State relationship under
the Clean Air Act, preparation of flexibility analysis would constitute
Federal inquiry into the economic reasonableness of State action. The
Clean Air Act forbids EPA to base its actions concerning SIPs on such
grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976);
42 U.S.C. 7410(a)(2).

D. Unfunded Mandates Reform Act

    Under sections 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
    EPA has determined that the disapproval action promulgated does not
include a Federal mandate that may result in estimated costs of $100
million or more to either State, local, or tribal governments in the
aggregate, or to the private sector. This Federal action disapproves
pre-existing requirements under State or local law, and imposes no new
requirements. Accordingly, no additional costs to State, local, or
tribal governments, or to the private sector, result from this action.

E. Executive Order 13132, Federalism

    Federalism (64 FR 43255, August 10, 1999) revokes and replaces
Executive Orders 12612 (Federalism) and 12875 (Enhancing the
Intergovernmental Partnership). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' Under Executive Order 13132, EPA may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or EPA
consults with State and local officials early in the process of
developing the proposed regulation. EPA also may not issue a regulation
that has federalism implications and that preempts State law unless the
Agency consults with State and local officials early in the process of
developing the proposed regulation.
    This rule will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132, because it
merely disapproves a State rule implementing a Federal standard, and
does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. Thus, the
requirements of section 6 of the Executive Order do not apply to this
rule.

F. Executive Order 13175, Coordination With Indian Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This final rule does not have
tribal implications, as specified in Executive Order 13175. It will not
have substantial direct effects on tribal governments, on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes. Thus, Executive Order 13175 does not
apply to this rule.

G. Executive Order 13045, Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
rule is not subject to Executive Order 13045, because it disapproves a
State rule implementing a Federal standard.

H. Executive Order 13211, Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12 of the National Technology Transfer and Advancement Act
(NTTAA) of 1995 requires Federal agencies to evaluate existing
technical standards when developing a new regulation. To comply with
NTTAA, EPA must consider and use ``voluntary consensus standards''
(VCS) if available and applicable when developing programs and policies
unless doing so would be inconsistent with applicable law or otherwise
impractical.
    The EPA believes that VCS are inapplicable to this action. Today's
action does not require the public to perform activities conducive to
the use of VCS.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Population

    Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent

practicable and permitted by law, to make environmental justice part of
their mission by identifying and addressing, as appropriate,
disproportionately high and adverse human health or environmental
effects of their programs, policies, and activities on minority
populations and low-income populations in the United States.
    EPA lacks the discretionary authority to address environmental
justice in this proposed rulemaking. In reviewing SIP submissions,
EPA's role is to approve or disapprove state choices, based on the
criteria of the Clean Air Act. Accordingly, this action merely
disapproves certain State requirements for inclusion into the SIP under
section 110 and subchapter I, part D of the Clean Air Act and will not
in-and-of itself create any new requirements. Accordingly, it does not
provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive
Order 12898.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective June 9, 2010.

L. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 9, 2010. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: March 18, 2010.
Jared Blumenfeld,
Regional Administrator, Region IX.

0
Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.242 is amended by adding paragraph (a)(1)(iii) to read as
follows:

Sec.  52.242  Disapproved rules and regulations.

    (a) * * *
    (1) * * *
    (iii) Rule 1175, ``Control of Emissions from the Manufacturing of
Polymeric Cellular (Foam) Products,'' submitted on March 7, 2008 and
adopted on September 7, 2007.
* * * * *
[FR Doc. 2010-10921 Filed 5-7-10; 8:45 am]
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[Federal Register Volume 85, Number 237 (Wednesday, December 9, 2020)]
[Notices]
[Page 79256]
[FR Doc No: 2020-27029]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-173, OMB Control No. 3235-0178]

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-02736

Extension:
    Rule 31a-1

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    Rule 31a-1 (17 CFR 270.31a-1) under the Investment Company Act of
1940 (the ``Act'') (15 U.S.C. 80a) is entitled ``Records to be
maintained by registered investment companies, certain majority-owned
subsidiaries thereof, and other persons having transactions with
registered investment companies.'' Rule 31a-1 requires registered
investment companies (``funds''), and every underwriter, broker,
dealer, or investment adviser that is a majority-owned subsidiary of a
fund, to maintain and keep current accounts, books, and other documents
which constitute the record forming the basis for financial statements
required to be filed pursuant to section 31 of the Act (15 U.S.C. 80a-
30) and of the auditor's certificates relating thereto. The rule lists
specific records to be maintained by funds. The rule also requires
certain underwriters, brokers, dealers, depositors, and investment
advisers to maintain the records that they are required to maintain
under federal securities laws. The Commission periodically inspects the
operations of funds to insure their compliance with the provisions of
the Act and the rules thereunder. The books and records required to be
maintained by rule 31a-1 constitute a major focus of the Commission's
inspection program.
    There are approximately 3,964 investment companies registered with
the Commission, all of which are required to comply with rule 31a-1.
For purposes of determining the burden imposed by rule 31a-1, the
Commission staff estimates that each fund is divided into approximately
four series, on average, and that each series is required to comply
with the recordkeeping requirements of rule 31a-1. Based on
conversations with fund representatives, it is estimated that rule 31a-
1 imposes an average burden of approximately 1,750 hours annually per
series for a total of 7,000 annual hours per fund. The estimated total
annual burden for all 3,964 funds subject to the rule therefore is
approximately 27,748,000 hours. Based on conversations with fund
representatives, however, the Commission staff estimates that even
absent the requirements of rule 31a-1, 90 percent of the records
created pursuant to the rule are the type that generally would be
created as a matter of normal business practice and to prepare
financial statements. Thus, the Commission staff estimates that the
total annual burden associated with rule 31a-1 is 2,774,800 hours.
    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act, and is not derived from a
comprehensive or even a representative survey or study. The collection
of information required by rule 31a-1 is mandatory. Responses will not
be kept confidential. The records required by rule 31a-1 are required
to be preserved pursuant to rule 31a-2 under the Investment Company Act
(17 CFR 270.31a-2). Rule 31a-2 requires that certain of these records
be preserved permanently, and that others be preserved six years from
the end of the fiscal year in which any transaction occurred. In both
cases, the records should be kept in an easily accessible place for the
first two years. 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 OMB control number.
    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.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or by
sending an email to<EMAIL_ADDRESS>
    Dated: December 4, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-27029 Filed 12-8-20; 8:45 am]
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