                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

                                                     OFFICE OF CHEMICAL SAFETY
                                                       AND POLLUTION PREVENTION

May 9, 2014

MEMORANDUM

SUBJECT:	Decision Document for Petition Number 1E7843:  FD&C Red No. 40 (CAS Reg. No. 25956-17-6); Human Health Risk Assessment and Ecological Effects Assessment for Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations.

            PC Code:				911363
      DP Barcode: 				N/A
            Decision No.:				N/A
      Regulatory Action:			 Inert Tolerance Exemption
							40 CFR 180.940(a)
      Petition No.:				1E7843
      All CAS Reg. Nos:			25956-17-6
      Inert Tracking No			N/A

FROM:	Roger Chesser, Biologist
		Inert Ingredient Assessment Branch (IIAB)
		Registration Division (7505P)

THRU:	Kerry Leifer, Team Leader
      Inert Ingredient Assessment Branch (IIAB)
      Registration Division (7505P)

TO:		P.V. Shah, Chief
		Inert Ingredient Assessment Branch (IIAB)
		Registration Division (7505P)

Table of Contents

Executive Summary
I.	Background	4
II.	Inert Ingredient Profile	5
III.	Human Health Assessment	6
A.	Summary of Toxicity Data	6
B. Toxicity Endpoint Selection	13
C. Special Consideration for Infants and Children	13
IV. Exposure Assessment	13
V. Aggregate Risk and Determination of Safety	13
Acute Dietary Risk	13
Chronic Dietary Risk	14
Aggregate Cancer Risk for U.S. Population	14
Short-Term Aggregate Risk	14
Intermediate-Term Aggregate Risk	14
Determination of Safety	14
VI. Occupational Exposure / Risk Pathway	14
Occupational Handler Risk	15
Occupational Post-Application Risk	15
*	Exposure Scenarios	15
VII. Cumulative exposure	16
VIII. Environmental Justice Statement	16
IX. Environmental Fate Considerations	17
X. Ecotoxicity	17
XI. Risk Characterization	17
References	18

Executive Summary

      Diversey, Inc. (8310 16[th] Street, MS 707, Sturtevant WI 53177-1964)  submitted a petition (1E7843) to establish an exemption from requirement of a tolerance, pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act, for the use of FD&C Red No. 40 as an antimicrobial pesticide formulation inert ingredient (colorant) in food contact surface sanitizer products under 40 CFR §180.940 (a) at a maximum level in the end-use concentration of 20 parts per million (ppm).  The majority of the data in this risk assessment decision document have been taken from the tolerance reassessment document for FD&C Red No. 40 dated December 21, 2004 (MRID 48779801) evaluating its use as an inert ingredient in pesticide formulations applied to growing crops and raw agricultural commodities after harvest (40 CFR 180.910), and to growing crops only (pre-harvest seed treatment) (40 CFR 180.920).
	  The reassessment document also summarized available information on the use, physical/chemical properties, toxicological effects, exposure profile, environmental fate, and ecotoxicity of FD&C Red No. 40, including data considered by the Joint Expert Committee on Food Additives of the Food and Agriculture Organization/World Health Organization (FAO/WHO) Expert Committee on Food Additives (JECFA) (MRIDs 48779804 and 48779805) as well as the European Food Safety Authority (EFSA) (MRID 48779803).    As summarized in that reassessment document, all toxicological studies were conducted at the limit dose or close to limit dose. No adverse toxicological effects were detected at these doses. A residential risk assessment was not performed since there are no residential uses.  No endpoint of concern was identified in the database.

      FD&C Red No. 40 is a FDA permanently listed color additive used in food, drugs and cosmetics, including drugs and cosmetics for eye area. The FDA's color additive evaluation included the consideration of an extensive set of toxicological data on FD&C Red No. 40.  FDA concluded that this colorant was safe and established a maximum acceptable daily intake for FD&C Red No. 40 of 7 mg/kg-bw/day.  Similarly, JECFA and SCF have evaluated FD&C Red No. 40 for the purpose of establishing estimates of acceptable daily intake (ADI) as a food additive.

      The JECFA and SCF evaluations of FD&C Red No. 40 included reviews of an extensive set of toxicological data including genotoxicity, chronic toxicity /carcinogenicity and reproductive and developmental toxicity.  Both evaluations concluded that the available data demonstrated that no adverse effects were seen in studies at limit dose levels. No hazard was identified in any of the data evaluated by JECFA for FD&C Red No. 40 at the limit dose of 1000 mg/kg/day to either parental animals or their offspring.  Acute oral toxicity was low based on studies with rats (LD50 > 10000 mg/kg bw). Based on other acute oral toxicity studies with rabbits and dogs, JECFA set the the LD50 values at > 10000 mg/kg bw and 5000 mg/kg bw, respectively.  The JECFA evaluation resulted in the establishment of an ADI of 7.0 mg/kg/day based on a chronic oral toxicity study in rats in which the no-observed-adverse-effect level (NOAEL) was 695 mg/kg/day (highest dose tested) with a safety factor of 100. (JECFA evaluation based upon Serota et al, 1977, as cited in JEFCA, 1980)  The JECFA and SCF evaluations of FD&C Red No. 40 established ADIs of 7.0 mg/kg/day based upon a chronic dietary toxicity study in rats in which the no-observed-adverse-effect level (NOAEL) was 750  mg/kg/day (highest dose tested) with a safety factor of 100.

      More recently, the European Food Safety Authority (EFSA) has reevaluated FD&C Red No. 40 and concluded that the present database does not give reason to revise the ADI of 7.0 mg/kg bw/day.  As a result of these extensive evaluations of FD&C Red No. 40, in which either no adverse effects were noted, or the effects of single or repeated dosing were observed only at levels beyond the respective limit doses, EPA has utilized a qualitative approach to assessing human health risks from exposure to FD&C Red No. 40.  No hazard endpoint of concern was identified for the acute and chronic dietary assessment (food and drinking water), or for the short, intermediate, and long term residential assessments (via all exposure routes), therefore, acute and chronic dietary and short-, intermediate, and long-term residential exposure assessments were not performed.

	Thus, due to its low potential hazard and the lack of a hazard endpoint, it has been determined that a quantitative risk assessment using safety factors applied to a point of departure protective of an identified hazard endpoint is not appropriate for FD&C Red No. 40 and an FQPA safety factor is not needed to protect the safety of infants and children.

      Residues of concern are not anticipated for dietary exposure (food and drinking water) or for residential exposure from the use of FD&C Red No. 40 for the proposed use pattern as an inert ingredient in pesticide products. EPA expects aggregate exposure to FD&C Red No. 40 to pose no appreciable dietary risk given that the data on FD&C Red No. 40 show a lack of any systemic toxicity at limit dose levels and a lack of any apparent developmental effects (SIDS).

      Taking into consideration all available information, EPA concludes that there is a reasonable certainty of no harm to the general population or to infants and children from aggregate exposure to FD&C Red No. 40 when used as an inert ingredient in pesticide formulations.  Therefore, the establishment of an exemption from the requirement of a tolerance under 40 CFR 180.940 (a) for FD&C Red No. 40 can be considered safe under section 408 of the FFDCA.

I. Background

Diversey, Inc. (8310 16[th] Street, MS 707, Sturtevant WI 53177-1964) is requesting EPA to establish a tolerance exemption for FD&C Red No. 40, CAS #: 25956-17-6 for use as an antimicrobial pesticide formulation inert ingredient (colorant) in no-rinse, food contact surface sanitizer products under 40 CFR § 180.940(a) at a maximum level in the end-use concentration of 20 parts per million (ppm).

In addition to the EPA approved uses as an inert ingredient in pesticides, FD&C Red No. 40  is approved by the Food and Drug Administration (FDA) as a color additive in food products as specified at 21 CFR §74.340, for use in drugs at 21 CFR §74.1340 and for use in cosmetics at 21 CFR §74.2340. It is permanently listed as safe for general use in these products.

      EPA completed reassessment of the current established tolerance exemption FD&C Red No. 40 in December 2004. The Agency concluded that taking into consideration all available information, including the extensive toxicology database in which no adverse effects were noted, the low toxicity, the lack of risk concerns from usage as color additives, and the low exposures likely to result from uses as pesticide active ingredients, that there was reasonable certainty of no harm to any population subgroup from aggregate exposure to FD&C Red No. 40 , considering dietary and all other non-occupational exposures.

      The European Food Safety Authority (EFSA); Panel on Food Additives and Nutrient Sources added to Food also reevaluated the safety of FD&C Red No. 40 as a food coloring additive and published their scientific opinion in 2009.  They concluded that no revisions to the current established ADI of 7 mg/kg/bw were needed.

      Taking into consideration all available information, EPA concludes that there is a reasonable certainty of no harm to the general population or to infants and children from aggregate exposure to FD&C Red No. 40 when used as an inert ingredient in pesticide formulations.  Therefore, the establishment of an exemption from the requirement of a tolerance under 40 CFR 180.940(a) for FD&C Red No. 40 can be considered safe under section 408 of the FFDCA.
II.	Inert Ingredient Profile

   A. Summary of  Uses
 FD&C Red No. 40 is used as an inert ingredient in pesticide formulations that are intended for application on growing crops or on raw agricultural commodities after harvest (40 CFR 180.910).  The colorant cannot be used above 0.002% (20 ppm) by weight in the formulation and must meet the certification requirements specified in 21 CFR 74.340.  FD&C Red No. 40 is similarly approved for use as a dye or coloring agent for seed treatment with a maximum concentration of 2% by weight in the pesticide formulation (40 CFR 180.920).

   B. Physical and Chemical Properties
Some of the physical and chemical characteristics of FD&C Red No. 40, along with its structure and nomenclature follow:

      Source ChemIDplus Lite
            Chemical Name: FD&C Red No. 40
            CAS No.:  25956-17-6
            Molecular Formula: C18-H16-N2-O8-S2.2Na
            Structure:

      Source SRC, 2004:
            Molecular Weight:  496.427
            Water solubility: 2.25 x 10[5]  mg/L at 25° C (M)
            Octanol-water Partition Coefficient (Kow)  log Kow= -0.550 (E)

            Source:  (MPBPVPWIN EPI Suite, 2000 as cited by IACM, 2003)
            MP:  350 C
            Vapor pressure: 1.25 x 10[5] mm Hg @  25° C
            Henry's Law Constant:  1 x 10-15 atm-m3/mole @ 25°C (estimated)

            Based on the above data, FD&C Red No. 40 has the following physicochemical profile:
               * Water soluble
               * Nonvolatile

III.	Human Health Assessment

   A. Summary of Toxicity Data

	The European Food Safety Authority (EFSA) has conducted the most recent (2009) full review of the toxicology of FD&C Red No. 40. This document relied heavily on the earlier reviews conducted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) which set the current, permanent Acceptable Daily Intake (ADI) of 07 mg/kg-bw/day.(JECFA, 1981).
Acute oral toxicity. No compound related effects were observed when FD&C Red No. 40 (Allura Red AC) was given to rats by gavage at doses varying from 215 to 10000 mg/kg. Based on these studies, JECFA set the LD50 for rats at 10000 mg/kg-bw. Other studies in rabbits, dogs and mice produced LD50 values of 10,000, 5000 and >2000 mg/kg, respectively. Overall, the EFSA concluded that "the acute oral toxicity of Allura Red AC (FD&C Red No. 40) is low."

 Dermal Toxicity Tests for dermal irritation in rabbits on intact and abraded skin showed no gross irritation at levels of .316, 1,03,16 abd 10 g/kg b/w of Allura Red. Daily applications of the color at rates of (JECFA, 1980 )

 Inhalation Toxicity. No studies available in the database.

 Primary Eye Irritation. No studies available in the database.

Table  1.    Acute Toxicity Profile of  FD&C Red No. 40

                                  Study Type

                                    Results
                               Toxicity Category

                              MRIDs # /Reference
Acute Oral - rat
LD50 > 10,000 mg/kg bw
                                      IV
                                48779804; JECFA
                                     1981
Acute Oral - rabbit
LD50 > 10,000 mg/kg bw
                                      IV
                                48779804; JECFA
                                     1981
Acute Oral - dog
LD50 = 5,000 mg/kg bw
                                      III
                                48779804; JECFA
                                     1981
Acute Oral - mice
LD50 > 2,000 mg/kg bw
                                      IV
                                48779804; JECFA
                                     1981
Primary Skin Irritation - rabbit
Minimal to mild irritation
                                      IV
                                48779804; JECFA
                                     1981

 Genotoxicity. EFSA cited reviews by the European Scientific Committee for Food (SCA), the JECFA and by TemaNord, to conclude that FD&C Red No. 40 was determined to be non-mutagenic in a variety of in vitro and in vivo based mutagenicity studies.  This determination is consistent with EPA's conclusion in the 2004 Tolerance Reassessment for FD&C Red No. 40 (EPA, 2004).

 In their 2009 review, EFSA cited a study from 2001 conducted on FD&C Red No. 40 using the Comet assay.  The study showed an increase in migration of nuclear DNA in the glandular stomach and the colon of male mice exposed to doses of FD&C Red No. 40 of 100 mg/kg-bw and 10 mg/kg-bw respectively.  Since histopathology of the effected organs appeared negative, the study authors concluded that observed effect was not likely to be related to cytotoxicity.  In light of the negative in vivo carcinogenicity studies conducted on FD&C Red No. 40 (see below), EFSA concluded that the significance of the Comet assay results was uncertain.

Reproductive and developmental toxicity. Relevant reproductive and developmental toxicity studies cited in the EFSA document are summarized in Table 1.   Blackmore, 1969, observed slight growth suppression in F1 and F2 pups exposed to 5.19% of FD&C Red No. 40 in the diet during a multi-generation type reproduction study in rats.  This dose was calculated to be equivalent to 2595 mg/kg/day.  The fetal No Adverse Effect Level (NOAEL) was 1.39% in the diet; equivalent to 695 mg/kg/day.  The maternal NOEAL was 5.19% in the diet, which was equivalent to 2595 mg/kg/day. No other significant anomalies were detected in growth, litter size, pup weight, gross pathology, implantation sites, resorption sites, live fetuses indices, appearance, anatomy and structure were observed.  The ADI of 7 mg/kg-bw/day for FD&C Red No. 40 was partially based on this study.

 Teratology studies in rats and rabbits showed no evidence of adverse effects at 200 mg/kg-bw/day (gestation day (g.d.) 0-19) and 700 mg/kg/day (g.d. 6-18), respectively.

 Reproductive toxicity endpoints were also monitored in three long-term studies.

 In a lifetime study in mice, the animals were fed up to 5.19% of FD&C Red No. 40 in the diet.  Animals were also exposed throughout gestation and lactation.  At the highest dose level, lower body weights and effects on organ weight and organ/body weight ratios were noted but considered to be "inconsequential."  (Serota et al., 1977a).

 In a nearly identical lifetime study with larger group numbers (100/sex/group versus
50/sex/group in the original study), no compound related adverse effects were observed.  The NOAEL's in both studies were determined to be 5.19% FD&C Red No. 40 in the diet, which was calculated to be equivalent to 7300 and 8300 mg/kg- bw/day in male and female mice, respectively.  (Reno et al., 1978)

 Dietary administration of 5.19% FD&C Red No. 40 in rats was also studied (Serota et al., 1977b).  Administration started throughout parental breeding, gestation and lactation and continued for 118 and 121 weeks in male and female rats, respectively. For the female rats in the study, mean body weights and growth rates were significantly lower in the high dose group relative to controls.  No other significant adverse effects were reported.  The NOAEL was 5.19% (2821 mg/kg-bw/day) in male rats and 1.3% (901 mg/kg-bw/day) in female rats.

 A review conducted by TemaNord, 2002, discussed four additional reproductive/developmental toxicity studies.

 Rats (group number not reported) were exposed to up to 10% of FD&C Red No. 40 in the diet (calculated doses of 0, 1250, 2500 and 5000 mg/kg-bw/day).  Litter mortality was increased between 22-24 days of age at a concentration of 10% in the diet.  Significantly decreased running wheel activity was observed in all exposed groups.  Increased open-field rearing was observed in the two highest dose groups. The Low Adverse Effect Level (LOAEL) was determined to be 1250 mg/kg-bw/day; a NOAEL could not be determined from this study (Voorhees, et al., 1983).

 In a mouse study, animals (10/sex/group) were exposed to up to 1.68% FD&C Red No. 40 in the diet over two generations (equivalent to 2400 mg/kg-bw/day). The study showed no significant, dose-related adverse effects on reproduction or
 neurobehavioral endpoints following exposure to FD&C Red No. 40 (Tanaka, 1994).

 In rats (group number not reported) dosed with FD&C Red No. 40 up to 0.7% in drinking water (equivalent to 939 mg/kg-bw/day) on g.d. 0-20, a significant increase in the incidence of fetuses with reduced ossification of the hyoid was observed at the highest dose level.  No other fetal malformations were observed.  The NOAEL from this study was determined to be 546 mg/kg-bw/day (Collins et al., 1989a).

 In rats dosed with FD&C Red No. 40 on g.d. 0-19 (group number not reported), no significant, dose-related effects were observed at doses up to 1000 mg/kg/day (Collins et al., 1989b).

 Subchronic toxicity. FD&C Red No. 40 was studied in rats, dogs and pigs in the following short-term studies.

 In rats, groups of 20 animals (10 males and 10 females per group) were fed diets containing 0-2595 mg/kg-bw/day) for six weeks.  The NOAEL was determined to be at least 2595 mg/kg-bw/day.

 Both of the dog studies were determined to be too limited to derive a NOAEL.

The pig study appeared to be a non-standard design.  Groups of 4 animals (2 males and 2 females per group) were dosed with 1000 mg/kg-bw/day of FD&C Red No. 40 for 21 days.  The dose was increased to 1500 mg/kg-bw/day for an additional 54 days.  No compound related effects were reported.

 Chronic toxicity. The chronic toxicity/carcinogenicity of FD&C Red No. 40 was studied in 5 key studies.  These are summarized in Table 2.

 In general, exposure to FD&C Red No. 40 did not result in significant adverse effects.  In one mouse study, higher rates of early onset lymphoma were observed in animals exposed to FD&C Red No. 40 (Serota et al., 1977a).  However, this observation was not statistically significant in this study and could not be replicated in a subsequent study that used a higher number of animals per group (100 versus 50) and an additional control group.  In general, the only significant effects reported in these studies appeared to be growth suppression or body weight reductions at high dietary doses used in these studies.

  Metabolism and Pharmacokinetics. The applicable studies were summarized in JECFA, 1980.  In rats fed 5.19% FD&C Red No. 40 in the diet, only 0.1% and 29% of the unmetabolized dye was found to be excreted in the urine and feces, respectively. Using 35S labeled FD&C Red No. 40, in dogs, 92-95% of the recovered radioactivity appeared in the feces and between 2.7 and 3.6% in the urine within 72 hours of administration.   In rats, 76-92% of the radioactivity was recovered in the feces and 5.7-19.8% in the urine within the same timeframe.  Significant retention of the dye was noted in the intestinal contents and in the washed intestines of both species. The total carcass and viscera of both species retained only 0.4% of the total administered dose.

 FD&C Red No. 40 is absorbed to a limited extent and the major route of excretion is through metabolic by-products eliminated through the feces.  Urinary excretion is negligible.

 Metabolite toxicology. Cresidine-4-sulfonic acid was identified as the major metabolite in the urine and feces of both rats and dogs along with the parent compound and two unknown metabolites.  In the dog, an additional unknown metabolite was observed in the feces and possibly the urine.  Metabolism in the GI tract may occur through the reduction of the azo group in the parent compound.

 EFSA, 2009, reported that FD&C Red No. 40 was able to inhibit aromatase activity in an in vitro rat ovarian microsome system with an IC50 of 24M.  Aromatase catalyzes the conversion of androgens to estrogens and presents a possible target for endocrine disrupting chemicals.  EFSA concluded; however, that these data did not trigger a concern for FD&C Red No. 40 since the chemical has limited systemic bioavailability and that there was no evidence of related adverse effects in the various reproduction studies conducted on the chemical.

Table 1: Summary of Reproductive and Developmental Toxicity Studies Conducted on FD&C Red No. 40 based on EFSA, 2009.
Reference
Study Type
Species
Duration
Dose
Summary
NOAEL
Blackmore et al., 1969
Reproduction (multi-generation)

Rat
10 male
10 female
Mating occurred after 27 weeks of exposure
0, 0.37, 0.72, 1.39 or 5.19 % in the diet.  Equivalent to 0, 185, 360, 695 and 2595 mg/kg-bw/day as recalculated by Borzelleca et al., 1991.)
Fertility indices for both filial generations were decreased in both treated and control groups.  Slight growth suppression was observed in high dose pups.  No other anomalies in regards to fertility, fetal development, teratology or pathology were observed.
695 mg/kg- bw/day based on the slight growth suppression observed in F1 and F2 pups in the 2595 mg/kg- bw/day dose group.[a]
Collins et al., 1974
Teratology
Rat
Gestation Day
0-19
0, 15,30, 100 and 200 mg/kg-bw/day
No compound related effects were observed.
200 mg/kg- bw/day
Reno, 1974
Teratology
Rabbit
Gestation Day
 6-18
0, 200 and 700 mg/kg-bw/day
No compound related effects were observed.
700 mg/kg- bw/day
Serota et al., 1977a; JECFA, 1980
Chronic
Mouse

50/sex/
group
Lifetime
0, 0.37, 1.39 and 5.19% in the diet

(equivalent to 0, 507, 1877 and 7422 mg/kg-bw/day in male mice and 0, 577, 2043 and 8304 mg/kg-bw/day in female mice- as recalculated by Borzelleca et al., 1991).
Animals were exposed through gestation and lactation.  At the highest dose levels, decreased body weight, organ weights and effects on organ/body weight were observed.   No significant compound related effects were observed.

The NOEAL was 5.19% in the diet, which is equivalent to:
Males- 7422 mg/kg-bw/day
Females- 8304 mg/kg-bw/day
Reno, et al., 1978.  Later published in Borzelleca, 1991
Chronic
Mouse
100/sex/
group
Two negative control groups
Lifetime
0, 0.37, 1.39 and 5.19% in the diet (equivalent to 0, 492, 1821 and 7318 mg/kg-bw/day in male mice and 0, 526, 2057 and 8356 mg/kg-bw/day in female mice- as recalculated by Borzelleca et al., 1991).
Sporadic changes in clinical signs, body weight, adrenal weights (both absolute and relative), food consumption and survival rates were observed.  None of the changes were significant or followed a dose-response relationship.

The NOEAL was 5.19% in the diet which is equivalent to Males- 7318 mg/kg-bw/day
Females- 8356 mg/kg-bw/day
Serota et al., 1977b; later published as Borzelleca et al., 1989)

Chronic with breeding
Rat
50/sex/
group
Lifetime- 118-121 weeks
0, 0.37, 1.39 and 5.19% Allura Red AC in the diet (equivalent to 180, 701 and 2829 mg/kg- bw/day for male and 0, 228, 901 and 3604 mg/kg-bw/day for female rats- as recalculated by Borzelleca et al., 1989)
Administration started throughout parental breeding, gestation and lactation, and lasted for 118 and 121 weeks for male and female rats, respectively.

In females, mean body weights and growth rates were significantly decreased (-12.5%) at 3604-m/kg bw/day.

Some abnormalities in gross pathological and histopathological appearance of the kidney were observed in groups fed FD&C Red No. 40. There was no observed dose-response relationship.

No compound-related adverse effects were observed, except for a reduction in body weight in high-dosed females at the end of the study. Borzelleca et al. (1989).
NOAELs in this study were 5.19% (2829 mg/kg-bw/day) for male rats and 1.39 % (901 mg/kg-bw/day) for female rats.[b]

Voorhees et al., 1983- from Tema Nord, 2004.
Multi-generation-2
Rat
Group number not recorded.
Not specified.
0, 2.5, 5 or 10%  FD&C Red No. 40 in the diet (equivalent to  0, 1250, 2500 and 5000 mg/kg-bw/day, respectively).
Reproductive success (dams producing litters) was reduced at all dose levels but effect was not dose-related.  Litter mortality was increased between 22-24 days of age at a concentration of 10% in the diet.  Significantly decreased running wheel activity as observed in all exposed groups.  Increased open-field rearing was observed in the two highest dose groups. (Voorhees  et al., 1983).

The LOAEL was determined to be 1250 mg/kg-bw/day. A NOAEL could not be determined from this study.
Tanaka, 1994
Multi-generation (2)
Mouse
10/sex/
group

0, 0.42, 0.84 or 1.68% in the diet (equivalent to 0, 600, 1200 and 2400 mg/kg-bw/day).
Animals showed no significant, dose-related adverse effects on reproduction or neurobehavioral endpoints following exposure to FD&C Red No. 40.
The NOAEL was determined to be 2400 mg/kg-bw/day.  No LOAEL could be determined.
Collins et al., 1989a
Teratology
Rat
Group number not recorded.
G.d. 0-20
0, 0.2, 0.4 or 0.7% in drinking water (equivalent to 0, 241, 546 and 939 mg/kg-bw/day).
A significant increase in the incidence of fetuses with reduced ossification of the hyoid was observed at the highest dose level.  No other fetal or maternal effects were observed.
The NOAEL from this study was determined to be 546 mg/kg-bw/day.

Collins et al., 1989b
Teratology
Rat
G.d. 0-19
0, 30, 75, 150, 300, 600 and 1000 mg/kg-bw/day by gavage.
No significant, dose-related effects were observed at doses up to 1000 mg/kg-bw/day.
The NOAEL from this study was determined to be 1000 mg/kg-bw/day.

B. Toxicity Endpoint Selection

No toxicological endpoints have been identified for FD&C Red No. 40 due to no adverse observable effects seen in toxicity studies at or above limit dose levels.
C. Special Consideration for Infants and Children

      At this time, there is no concern for potential sensitivity to infants and children resulting from exposures to FD&C Red No. 40.  There is no reported quantitative or qualitative evidence of increased susceptibility of rat fetuses to in utero exposure to FD&C Red No. 40 in developmental toxicity studies in rats. No quantitative or qualitative evidence of increased susceptibility has been reported following the pre/postnatal exposure to rats in 2-generation reproduction toxicity studies in rats.  Given the lack of adverse toxicological effects at limit dose levels, a safety factor analysis has not been used to assess the risk.  For these reasons the additional tenfold safety factor is unnecessary.
IV. Exposure Assessment

      No hazard endpoint of concern was identified for the acute and chronic dietary assessment (food and drinking water), or for the short, intermediate, and long term residential assessments (via all exposure routes), therefore, acute and chronic dietary and short-, intermediate, and long-term residential exposure assessments were not performed for FD&C Red No. 40.  In addition, exposures to FD&C Red No 40 resulting from its use as an inert ingredient in pesticide formulations would be orders of magnitude less than the ADI's established for FD&C Red No. 40 by FDA/JECFA/SCF.

V. Aggregate Risk and Determination of Safety

      EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD.  The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate safety factors (SFs).  EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs.  For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure.  Short-, intermediate, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD. The MOE is the product of all applicable UFs and should not be exceeded.

Acute Dietary Risk

An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water using the exposure assumptions discussed in section IV for acute exposure and the use limitations in pesticide formulations. There was no hazard attributable to a single exposure seen in the toxicity database for FD&C Red No. 40; therefore an acute aggregate risk assessment is not required.

Chronic Dietary Risk

A chronic aggregate risk assessment takes into account exposure estimates from chronic dietary consumption of food and drinking water using the exposure assumptions discussed in section IV for chronic exposure and the use limitations in pesticide formulations.  There was no hazard attributable to chronic exposures in the toxicity database for FD&C Red No. 40; therefore a chronic aggregate risk assessment is not required.

Aggregate Cancer Risk for U.S. Population

The Agency has not identified any concerns for carcinogenicity relating to FD&C Red No. 40; therefore, a cancer dietary exposure assessment was not performed and an aggregate risk assessment is not a concern.

Short-Term Aggregate Risk

 Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). FD&C Red No. 40 is used as an inert ingredient in pesticide products that are currently registered for uses that could result in short-term residential exposure however no adverse effects were attributable to short-term exposure to FD&C Red No. 40 were seen in the toxicity database; therefore, a short-term aggregate risk assessment is not required.

Intermediate-Term Aggregate Risk

Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). FD&C Red No. 40 is used as an inert ingredient in pesticide products that are currently registered for uses that could result in intermediate-term residential exposure however no adverse effects were attributable to intermediate-term exposure to FD&C Red No. 40 were seen in the toxicity database; therefore, an intermediate-term aggregate risk assessment is not required.

      Determination of Safety

 EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of FD&C Red No. 40.
VI. Occupational Exposure / Risk Pathway

The representative occupational scenarios selected by the Agency for assessment are evaluated based on likely maximum application rates for products which may contain the inert ingredient for the short-term exposure assessment, and average application rates for products likely to contain the inert ingredient for the intermediate- and long-term exposure durations.  Active ingredient application rates are corrected for the maximum amount of inert ingredient likely to be in the final formulations to determine exposure and risk from exposure to the inert ingredient by fungicide, insecticide or herbicide.

RD traditionally considers a level of concern (LOC) for these risk assessments to be an MOE of 100 based on the standard 10X inter and 10X intra species extrapolation safety factors and additional uncertainty in the database.

Occupational Handler Risk

   * Exposure Scenarios

Due to the absence of dermal and inhalation toxicity endpoints, occupational handler risks are not of concern.  Therefore an occupational handler risk assessment was not performed.

Occupational Post-Application Risk
   * Exposure Scenarios

RD uses the term post-application to describe exposures that occur when individuals are present in an environment that has been previously treated with a pesticide (also referred to as re-entry exposure).  Such exposures may occur when workers enter previously treated areas to perform job functions, including activities related to crop production, such as scouting for pests or harvesting.  Post-application exposure levels vary over time and depend on such things as the type of activity, the nature of the crop or target that was treated, the type of pesticide application, and the chemical's degradation properties.  In addition, the timing of pesticide applications, relative to harvest activities, can greatly reduce the potential for post-application exposure. Inhalation exposures are not typically calculated for occupational post-application scenarios because inhalation exposures generally account for a negligible percentage of the overall body burden for most pesticide chemicals.

Due to the absence of dermal and inhalation toxicity endpoints, occupational post-application risks are not of concern. Therefore an occupational post-application risk assessment was not performed.
VII. Cumulative exposure

Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of 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 has not found FD&C Red No. 40 to share a common mechanism of toxicity with any other substances, and that FD&C Red No. 40 does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that FD&C Red No. 40 does not 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 EPA's website at http://www.epa.gov/pesticides/cumulative.

VIII. Environmental Justice Statement
      Potential areas of environmental justice concerns, to the extent possible, were considered in this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations," http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf.

As a part of every pesticide risk assessment, OPP considers a large variety of consumer subgroups according to well-established procedures.  In line with OPP policy, RD estimates risks to population subgroups from pesticide exposures that are based on patterns of that subgroup's food and water consumption, and activities in and around the home that involve pesticide use in a residential setting.  Extensive data on food consumption patterns are compiled by the USDA under the Continuing Survey of Food Intakes by Individuals (CSFII) and are used in pesticide risk assessments for all registered food uses of a pesticide.  These data are analyzed and categorized by subgroups based on age, season of the year, ethnic group, and region of the country.  Additionally, OPP is able to assess dietary exposure to smaller, specialized subgroups and exposure assessments are performed when conditions or circumstances warrant.  Whenever appropriate, non-dietary exposures based on home use of pesticide products and associated risks for adult applicators and for toddlers, youths, and adults entering or playing on treated areas post-application are evaluated.  Further considerations are currently in development as OPP has committed resources and expertise to the development of specialized software and models that consider exposure to bystanders and farm workers as well as lifestyle and traditional dietary patterns among specific subgroups.
IX. Environmental Fate Considerations

      FD&C Red No. 40 is water soluble, mobile and not readily biodegradable. It is essentially nonvolatile; volatilization from soils and water is not likely to be a transport process in the environment.

      EPA reviewed the environmental impact from use of FD&C Red No. 40 in agricultural pesticides.  In agricultural use, the products are discharged directly into the environment without treatment.  Based on their review, EPA concluded that "modeling results indicate that expected potential risks to aquatic organisms and soil and sediment dwelling organisms resulting from the use of FD&C Red No. 40 as an inert ingredient in pesticide formulations is low." (EPA, 2004)

      No-rinse food contact sanitizing solutions are typically indoor use products.  These products are used at commercial facilities where there is no direct discharge to the environment during recommended use.  The used solutions are drained into the sanitary sewer of the facility, where they are treated in accordance with permits issued under the Clean Water Act.  After leaving the food processing facility, the concentration of FD&C Red No. 40 in the waste-water will be reduced further by dilution with other waste streams and by processing at the waste water treatment facility.  Therefore, the ultimate concentration of FD&C Red No. 40 discharged by a waste-water treatment facility to the environment would be negligible

X. Ecotoxicity

There are no available aquatic toxicity studies on FD&C Red No. 40 (ECOTOX, 2002), however, based on estimates of toxicity using physical and chemical property data, FD&C Red No. 40 would be of low concern for toxicity to fish, algae, and aquatic invertebrates as well as terrestrial/benthic organisms (ECOSAR, 2000).

XI. Risk Characterization

      No toxicological endpoints have been identified for FD&C Red No. 40 due to no adverse observable effects seen in toxicity studies at doses at or above limit dose levels .

The toxicity database for FD&C Red No. 40 is adequate for FQPA assessment and the potential exposure is adequately characterized given the low toxicity of the chemical. No hazard was identified and there is no residual uncertainty regarding prenatal and/or postnatal toxicity.  No acute or subchronic neurotoxicity studies are available, but there were no clinical signs of neurotoxicity or any systemic toxicity observed in the available database at doses up to and exceeding limit dose levels.  No developmental or reproductive effects were seen in the available studies at doses at or above limit dose levels. Based on this information, there is no concern, at this time, for increased sensitivity to infants and children to FD&C Red No. 40 when used as a component of food contact sanitizing solutions applied to all food contact surfaces and a safety factor analysis has not been used to assess risk. For the same reason, EPA has determined that an additional safety factor is not needed.  The Agency believes that any exposure to FD&C Red No. 40 used as an inert ingredient in pesticide formulations would occur at a level much lower then an effect level noted in animal studies.

      EPA has determined that the available data supports an exemption from the requirement of a tolerance for residues of FD&C Red No. 40 (CAS Reg. No 25956-17-6) as a pesticide inert ingredient (dye) in antimicrobial formulations in accordance with 40 CFR 180.940 (a) as requested by the petitioner. There is a reasonable certainty that no harm to any population subgroup will result from FD&C Red No. 40 when used as inert ingredient in pesticide antimicrobial formulations applied to food contact surfaces in public eating places, dairy processing equipment, food processing equipment and utensils, as result of aggregate exposure.  Therefore, it is recommended that a tolerance exemption for FD&C Red No. 40 (CAS Reg. No. 25956-17-6) be established for use as an inert ingredient (dye), limited to 20 ppm, in antimicrobial formulations under 40 CFR 180.940(a), which includes use on food contact surfaces in public eating places, dairy processing equipment and food processing equipment and utensils.

References

ChemIDplus, 2004, ChemIDplus Advanced. U.S. National Library of Medicine. National Institutes of Health. Department of Health and Human Services. Online Search Database http://chem.sis.nlm.nih.gov/chemidplus/
Search terms: FD&C Red No. 40. (May 7, 2014)

ECOSAR. 2000.  Ecological Structure Activity Relationships Version 0.99g.  Environmental Protection Agency.

ECOTOX.   U.S. Environmental Protection Agency. 2002. ECOTOX User Guide:  ECOTOXicology Database System. Version 4.0  http://www.epa.gov/ecotox/
Search terms: CAS Reg Nos: 25956-17-6 (July 9, 2013)

EFSA. 1980. Joint Food and Agriculture Organization (FAO) and World Health Organization (WHO) Committee on Food Additives. "JECFA Evaluation  -  Allura RED AC". MRID 48779805

EFSA. 1981. Joint Food and Agriculture Organization (FAO) and World Health Organization (WHO) Committee on Food Additives. "Evaluation of certain food additives".  MRID 48779804

EFSA. 2009. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. MRID 48779803

EPA, ISK Biosciences Corporation (2011); Information Submitted to Support Petition Number 1E7843, Petition Proposing an Exemption from The Requirement of a Tolerance for Residues of FD&C Red No. 40 In or On Raw Agricultural Products and Food Products

EPI Suite. 2004. Estimation Programs Interface Suite Version 3.12 (August 17, 2004).
Environmental Protection Agency. http://www.epa.gov/opptintr/exposure/docs/episuite.htm

JECFA. 1980. Joint FAO/WHO Expert Committee on Food Additives.  Allura Red AC.  WHO Food Additive Series Vol. 15.  http://www.inchem.org/documents/jecfa/jecmono/v15je02..htm

US Environmental Protection Agency (EPA), December 21, 2004, Action Memorandum, Dan Rosenblatt, Chief Minor Use, Inerts and Emergency Response Branch to Lois Rossi, Director Registration Division, Inert Ingredient Tolerance Reassessment  -  FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 5 (Tartrazine). MRID 48779801


[Federal Register: July 15, 2008 (Volume 73, Number 136)]
[Notices]
[Page 40574-40575]
[DOCID:fr15jy08-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL08-71-000]

TexMex Energy, LLC; Notice of Filing

July 8, 2008.
    Take notice that on June 19, 2008, TexMex Energy, LLC filed a
Petition for Declaratory Order resolving jurisdictional uncertainty
regarding the operation and use of the ``Eagle Pass DC Tie'' between
the Electric Reliability Council of Texas Region and the grid
controlled by the Comision Federal de Electricidad.
    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. On or before the comment date,
it is not necessary to serve motions to intervene or protests on
persons other than the Applicant.
    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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 15, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-16050 Filed 7-14-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Page 61727]
[FR Doc No: 2011-25695]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3340-EM; Docket ID FEMA-2011-0001]

Pennsylvania; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the Commonwealth of Pennsylvania (FEMA-3340-EM), dated
September 8, 2011, and related determinations.

DATES: Effective Date: September 8, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 8, 2011, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the Commonwealth of Pennsylvania resulting from the Remnants of
Tropical Storm Lee beginning on September 3, 2011, and continuing,
are of sufficient severity and magnitude to warrant an emergency
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (``the Stafford
Act''). Therefore, I declare that such an emergency exists in the
Commonwealth of Pennsylvania.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), including direct Federal assistance, under the Public
Assistance program. This assistance excludes regular time costs for
subgrantees' regular employees.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Thomas
J. McCool, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the Commonwealth of Pennsylvania have been
designated as adversely affected by this declared emergency:

    Adams, Bedford, Berks, Blair, Bradford, Bucks, Cambria, Carbon,
Centre, Chester, Clinton, Columbia, Cumberland, Dauphin, Delaware,
Franklin, Fulton, Huntingdon, Juniata, Lackawanna, Lancaster,
Lebanon, Lehigh, Luzerne, Lycoming, Mifflin, Monroe, Montgomery,
Montour, Northampton, Northumberland, Perry, Philadelphia,
Schuylkill, Snyder, Somerset, Sullivan, Susquehanna, Tioga, Union,
Wyoming, and York Counties for emergency protective measures
(Category B), including direct Federal assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-25695 Filed 10-4-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 74 (Wednesday, April 17, 2019)]
[Rules and Regulations]
[Pages 15949-15952]
[FR Doc No: 2019-07587]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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

Federal Register / Vol. 84, No. 74 / Wednesday, April 17, 2019 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0899; Product Identifier 2018-NM-099-AD; Amendment
39-19615; AD 2019-07-04]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model 757 airplanes. This AD was prompted by an
evaluation by the design approval holder (DAH) indicating that the
inner skin of the lap splices, at the lower fastener row, is subject to
scratch cracks that may interact with widespread fatigue damage (WFD).
This AD requires a general visual inspection (GVI) of certain lap
splice inspection areas for any repair common to the fuselage skin lap
splice dual frequency eddy current (DFEC) inspection areas, repetitive
DFEC inspections of certain lap splice inner skins for any crack, and
applicable on-condition actions. We are issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective May 22, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 22,
2019.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; phone:<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0899.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0899; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: David Truong, Aerospace Engineer,
Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount
Boulevard, Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; fax: 562-627-
5210; email: [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain The Boeing Company
Model 757 airplanes. The NPRM published in the Federal Register on
October 15, 2018 (83 FR 51887). The NPRM was prompted by an evaluation
by the DAH indicating that the inner skin of the lap splices, at the
lower fastener row, is subject to scratch cracks that may interact with
WFD. The NPRM proposed to require a general visual inspection of
certain lap splice inspection areas for any repair common to the
fuselage skin lap splice inspection areas, repetitive DFEC inspections
of a certain lap splice inner skin for any crack, and applicable on-
condition actions.
    We are issuing this AD to address scratches that can grow into
scratch cracks, which could interact with multi-site damage (MSD)
fastener hole fatigue cracking. This condition, if not addressed, could
result in accelerated crack growth rate, which could result in reduced
structural integrity of the airplane.

Comments

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

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that accomplishing Supplemental
Type Certificate (STC) ST01518SE does not affect the actions specified
in the proposed AD.
    We concur with the commenter. We have redesignated paragraph (c) of
the proposed AD as paragraph (c)(1) of this AD and added paragraph
(c)(2) to this AD to state that installation of STC ST01518SE does not
affect the ability to accomplish the actions required by this AD.
Therefore, for airplanes on which STC ST01518SE is installed, a
``change in product'' alternative method of compliance (AMOC) approval
request is not necessary to comply with the requirements of 14 CFR
39.17.

Request for Clarification of the Affected Airplanes

    Boeing requested that we clarify the affected airplanes in the
NPRM. Boeing pointed out that the SUMMARY of the NPRM currently states
``for certain The Boeing Company Model 757 airplanes,'' and requested
that we change the SUMMARY of the NPRM to state ``for all The Boeing
Company Model 757 airplanes.''
    We acknowledge this typographical error. Boeing Alert Requirements
Bulletin 757-53A0111 RB, dated May 21, 2018, specifies ``all The Boeing
Company Model 757 airplanes,'' and our intent was to match the service
information. We have revised the SUMMARY and paragraph (c)(1) of this
AD accordingly.

Request To Revise the Safety Issue

    Boeing requested that we clarify the nature of the safety issue.
Boeing pointed out that the SUMMARY of the NPRM suggests that the
safety issue is limited to WFD. Boeing also mentioned that lap splice
WFD for the Model 757 fleet is already addressed by AD 2018-18-07,
Amendment 39-19386 (83 FR

45037, September 5, 2018) (``AD 2018-18-07''). Boeing specified that
the safety issue that the NPRM is mitigating is the potential for
interaction between MSD and scratch cracks on the inner skin of the lap
splices. Boeing requested that we revise the ``prompted by'' statement
in the SUMMARY of the NPRM to specify ``. . . at the lower fastener row
is subject to scratch cracks that may interact with WFD.''
    We acknowledge the commenter's concern. As written, the SUMMARY of
the NPRM can be misconstrued to specify duplicate actions (lap splice
WFD) already addressed by AD 2018-18-07. The intent of this AD action
is to address the potential for interaction between MSD and scratch
cracks on the inner skin of the lap splices. Therefore, we have revised
the SUMMARY and paragraph (e) of this AD accordingly.

Request for Clarification of the GVI Inspection Area

    Boeing requested that we clarify the GVI inspection area. Boeing
mentioned that the SUMMARY and ``Related Service Information Under 1
CFR part 51'' section of the NPRM each describe a GVI common to the
fuselage skin lap splice inspection areas. Boeing pointed out that the
wording seems confusing and could be perceived as a circular
description (i.e. that the inspection area is common to the inspection
area). Boeing also pointed out that there is no mention of the
commonality of the DFEC inspection areas and the GVI inspection areas.
    We agree with the commenter's request for the reasons provided. We
have revised the SUMMARY and ``Related Service Information Under 1 CFR
part 51'' section of this AD accordingly.

Request for Clarification of the Affected Inspection Area

    Boeing requested that we clarify the affected inspection area.
Boeing mentioned that the SUMMARY of the NPRM states ``. . . DFEC
inspections of a certain lap splice inner skin. . . .'' Boeing pointed
out that this statement suggests that only one skin panel is affected.
Boeing requested that we revise the SUMMARY of the NPRM to state ``. .
. DFEC inspections of certain lap splice inner skins. . . .''
    We agree with the commenter's request for the reasons provided. We
have revised the SUMMARY of this AD accordingly.

Request To Clarify That the Inspections Are Not Limited to Lap Splices
at Stringer (S) 14

    Boeing requested that we clarify that the inspections are not
limited to lap splices at S-14. Boeing mentioned that the ``Related
Service Information Under 1 CFR part 51'' section of the NPRM describes
the service information as procedures for ``. . . repetitive DFEC
inspections of the S-14 lap splice inner skin for any crack . . . .''
Boeing pointed out that the description does not mention any of the
other lap splice stringer locations where the inspections are required.
Boeing requested that we revise the description to specify ``. . .
repetitive DFEC inspections of certain lap splice inner skins for any
crack . . . .''
    We agree with the commenter's request for the reasons provided. We
have revised the ``Related Service Information Under 1 CFR part 51''
section of this AD accordingly.

Request To Revise the Costs of Compliance of the NPRM

    Boeing requested that we clarify the Costs of Compliance of the
NPRM. Boeing mentioned that the NPRM specified 451 airplanes of U.S.
registry. Boing specified that its records show there to be 561
airplanes of U.S. registry that would be affected by the NPRM. Boeing
also pointed out that the difference in affected airplanes
significantly increases the overall costs to the U.S. registered Model
757 fleet.
    We agree that Boeing records account for U.S. registered airplanes
that the FAA did not include in the NPRM, and that this number may be a
more accurate representation of the U.S. registered airplanes. We did
not originally include airplanes in our cost estimate that are in
storage or not currently active. We have updated the Costs of
Compliance section of this AD to reflect the specific number of U.S.
registered airplanes and the revised cost on U.S. operators.

Request To Include Required for Compliance (RC) Language

    Boeing requested that we revise paragraph (i) of the proposed AD to
include RC language. Boeing mentioned that this change would clarify
which actions are mandated.
    We agree that clarification is necessary, however, we disagree with
the request to include RC language in paragraph (i) of this AD. As
noted in Boeing Alert Requirements Bulletin 757-53A0111 RB, dated May
21, 2018, if an RB is mandated by an AD, then all applicable
requirements specified in the RB must be done. We did not include RC
language because this AD requires accomplishment of all the actions
specified in the Accomplishment Instructions of Boeing Alert
Requirements Bulletin 757-53A0111 RB, dated May 21, 2018. Therefore, we
have not changed this AD in this regard.

Request To Exclude Airplanes With Certain Modifications

    FedEx and VT Mobile Aerospace Engineering (MAE) Inc. requested that
we revise the NPRM to specify that inspections, methods, and compliance
times regarding certain lap splices specified in Boeing Alert
Requirements Bulletin 757-53A0111 RB, dated May 21, 2018, be omitted
for the FedEx fleet of Model 757-200 airplanes. FedEx mentioned that
its fleet has been modified using certain VT MAE Inc. supplemental type
certificates (STCs), and is no longer configured as passenger
airplanes. FedEx pointed out that its Model 757-200 fleet is identified
as Groups 1, 4, and 5 in Boeing Alert Requirements Bulletin 757-53A0111
RB, dated May 21, 2018. VT MAE Inc. pointed out that because of the
change in configuration related to the VT MAE Inc. STCs, certain lap
splice inspection areas have been removed and those airplanes are
unable to fully comply with the inspection procedures specified in
Boeing Alert Requirements Bulletin 757-53A0111 RB, dated May 21, 2018.
VT MAE Inc. proposed certain exceptions to the service information in
the final rule. The proposed exceptions are for the lap splice
inspections affected by the change in configuration related to the VT
MAE Inc. STCs. FedEx requested that, in lieu of requesting an AMOC
after publication, we include the exceptions proposed by VT MAE Inc. in
the final rule.
    We acknowledge the commenters' remarks, however, we disagree with
the request to include exceptions in this final rule that are specific
to certain airplanes operated by FedEx. There are many different
airplane configurations across multiple operators, and ADs cannot
accommodate all possible configurations. However, under the provisions
of paragraph (i) of this AD, we will consider requests for approval of
an AMOC that addresses the VT MAE Inc. STCs, if appropriate data are
submitted to substantiate that the method would provide an acceptable
level of safety. We have not changed this AD in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule with the changes described previously and minor
editorial changes. We have determined that these minor changes:

     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Requirements Bulletin 757-53A0111 RB,
dated May 21, 2018. This service information describes procedures for a
GVI of certain lap splice inspection areas for any repair common to the
fuselage skin lap splice DFEC inspection areas, repetitive DFEC
inspections of certain lap splice inner skins for any crack, and
applicable on-condition actions. This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 561 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
General visual inspection........  Up to 6 work-hours               $0  Up to $510.........  Up to $286,110.
                                    x $85 per hour =
                                    up to $510.
Repetitive DFEC inspections......  Up to 124 work-                  $0  Up to $10,540 per    Up to $5,912,940
                                    hours x $85 per                      inspection cycle.    per inspection
                                    hour = up to                                              cycle.
                                    $10,540 per
                                    inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2019-07 The Boeing Company: Amendment 39-19615; Docket No. FAA-2018-
0899; Product Identifier 2018-NM-099-AD.

(a) Effective Date

    This AD is effective May 22, 2019.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to all The Boeing Company Model 757-200, -
200PF, -200CB, and -300 series airplanes, certificated in any
category.
    (2) Installation of Supplemental Type Certificate (STC)
ST01518SE does not affect the ability to accomplish the actions
required by this AD. Therefore, for airplanes on which STC ST01518SE
is installed, a ``change in product'' alternative method of
compliance (AMOC) approval request is not necessary to comply with
the requirements of 14 CFR 39.17.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by an evaluation by the design approval
holder (DAH) indicating that the inner skin of the lap splices, at
the lower fastener row, is subject to scratch cracks that may
interact with widespread fatigue damage (WFD). We are issuing this
AD to address scratches that can grow into scratch cracks, which
could interact with multi-site damage (MSD) fastener hole fatigue
cracking. This condition, if not addressed, could result in
accelerated crack growth rate, which could result in reduced
structural integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Except as specified by paragraph (h) of this AD: At the
applicable times specified in the ``Compliance'' paragraph of Boeing
Alert Requirements Bulletin 757-53A0111 RB, dated May 21, 2018, do
all applicable actions identified in, and in accordance with, the
Accomplishment Instructions of Boeing Alert Requirements Bulletin
757-53A0111 RB, dated May 21, 2018.
    Note 1 to paragraph (g) of this AD: Guidance for accomplishing
the actions required by this AD can be found in Boeing Alert Service
Bulletin 757-53A0111, dated May 21, 2018, which is referred to in
Boeing Alert Requirements Bulletin 757-53A0111 RB, dated May 21,
2018.

(h) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements
of this AD: Where Boeing Alert Requirements Bulletin 757-53A0111 RB,
dated May 21, 2018, uses the phrase ``the original issue date of
Requirements Bulletin 757-53A0111 RB,'' this AD requires using ``the
effective date of this AD.''
    (2) Where Boeing Alert Requirements Bulletin 757-53A0111 RB,
dated May 21, 2018, specifies contacting Boeing for alternative
inspections or repair instructions, this AD requires alternative
inspection or repair before further flight using a method approved
in accordance with the procedures specified in paragraph (i) of this
AD.
    (3) Inspections performed in accordance with Boeing Alert
Requirements Bulletin 757-53A0111 RB, dated May 21, 2018, are not
necessary in areas where existing FAA approved repairs cover the
affected inspection areas; provided the outermost repair doubler
extends a minimum of three rows of fasteners above and below the
original group of lap splice fasteners subject to the inspection.
Damage tolerance inspections specified for existing repairs must
continue. Inspections outside of the repaired boundaries are still
required as specified in Boeing Alert Requirements Bulletin 757-
53A0111 RB, dated May 21, 2018.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO Branch, FAA, has the authority
to approve AMOCs for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your
request to your principal inspector or local Flight Standards
District Office, as appropriate. If sending information directly to
the manager of the certification office, send it to the attention of
the person identified in paragraph (j)(1) of this AD. Information
may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Los Angeles ACO Branch, FAA, to make those findings. To be
approved, the repair method, modification deviation, or alteration
deviation must meet the certification basis of the airplane, and the
approval must specifically refer to this AD.

(j) Related Information

    (1) For more information about this AD, contact David Truong,
Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch,
3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-
5224; fax:<PHONE_NUMBER>; email: [email protected].
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (k)(4) of this AD.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Requirements Bulletin 757-53A0111 RB, dated May
21, 2018.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; phone:<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on April 8, 2019.
Michael J. Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-07587 Filed 4-16-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: June 8, 2006 (Volume 71, Number 110)]
[Notices]
[Page 33330-33331]
[DOCID:fr08jn06-96]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53933; File No. SR-Phlx-2006-29]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to the PHLX/KBW Bank Index

 June 1, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 4, 2006, the Philadelphia Stock Exchange, Inc. (``Exchange'' or
``Phlx'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
filed the proposed rule change as a ``non-controversial'' rule change
under Rule 19b-4(f)(6) under the Act,\3\ which rendered the proposal
effective upon filing with the Commission. 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.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to change the method of calculation and
dissemination of the PHLX/KBW Bank Index (``Index''). In particular,
the Exchange proposes to calculate and disseminate current index values
itself, in the event that the official calculation agent, Bridge Data,
is temporarily unable to calculate and disseminate the values due to
technical difficulties.\4\
---------------------------------------------------------------------------

    \4\ Telephone conference between Carla Behnfeldt, Director,
Legal Department, New Product Development Group, Phlx, and Florence
E. Harmon, Senior Special Counsel, Division of Market Regulation,
Commission, on June 1, 2006.
---------------------------------------------------------------------------

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 Exchange 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 these 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 aspects 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 the proposed rule change is to permit the Exchange
itself, in certain circumstances, to calculate and disseminate current
index values of the Index, an index developed by Keefe, Bruyette &
Woods, Inc. (``KBW''), a registered broker-dealer that specializes in
U.S. bank stocks. Under the proposal, the Exchange would calculate and
disseminate the index values itself in the event that Bridge Data, the
official calculation agent, is temporarily unable to calculate and
disseminate the values due to technical difficulties. No other changes
are being made to the Index. The Exchange seeks continued approval to
list and trade options on the Index in view of this change.
    The Index was originally listed in 1992 as a narrow-based
(industry) index. The Commission's approval order (``Approval Order'')
\5\ contains the following language regarding the calculation of the
underlying current index value:

    \5\ See Securities Exchange Act Release No. 31145 (September 3,
1992), 57 FR 41531 (September 10, 1992) (SR-Phlx-91-27).
---------------------------------------------------------------------------

    Even though the Index will be maintained by KBW, the Phlx
represents that the Exchange will be solely responsible for the
calculation of the Index and that the Index value will be calculated
and disseminated in such a way that neither KBW nor any other party
will be in receipt of the Index value prior to the public
dissemination of the value. In this connection, the Phlx has made
arrangements for the Index to be calculated by an independent third
party, Bridge Data, a vendor of financial information. Bridge Data
will calculate and disseminate the Index value to the Options Price
Reporting Authority (``OPRA'') four times per minute during the
trading day, using the last sale prices of the component stocks in
the Index. * * * OPRA, in turn, will disseminate the Index value to
other financial vendors such as Reuters, Telerate, and Quotron.\6\

    \6\ Id.
---------------------------------------------------------------------------

    The Exchange is now capable of calculating and disseminating the
Index value at least every 15 seconds per trading day,\7\ using the
last sale prices of the component stocks in the Index, without
utilizing the services of Bridge Data. The Exchange seeks approval to
continue listing and trading options on the Index from time to time
without the participation or intervention of Bridge Data in the process
of calculating or disseminating the Index value.\8\ In connection with
this filing, Phlx has reconfirmed that KBW has appropriate information
barriers around the personnel who have access to information concerning
changes and adjustments to the Index and confirmed that the Exchange,
as calculation agent for the Index, is independent from KBW, a broker-
dealer.\9\
---------------------------------------------------------------------------

    \7\ Telephone conference between Carla Behnfeldt, Director,
Legal Department, New Product Development Group, Phlx, and David L.
Orlic, Special Counsel, Division of Market Regulation, Commission,
on May 26, 2006.
    \8\ The Exchange notes that Index values are disseminated not to
OPRA, but rather to the Consolidated Tape Association for further
dissemination to major market data vendors.
    \9\ See supra note 6.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \10\ in general, and furthers the
objectives of Sections 6(b)(5) of the Act \11\ in particular, in that
it is designed to promote just and equitable principles of trade, 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, by permitting the calculation and
dissemination of current index values to be accomplished by Exchange
personnel, in addition to by Bridge Data, which should assure
continuity in the availability of the Index's current value in the
event that Bridge Data is unavailable to calculate and disseminate the
values as described in the Approval Order.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose 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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Because the proposed rule change: (i) Does not significantly affect
the protection of investors or the public interest; (ii) does not
impose any significant burden on competition; and (iii) by its terms,
does not become

operative for 30 days after the date of filing, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\13\ The Exchange has
requested that the Commission waive the five-day pre-filing notice and
the 30-day operative delay for ``non-controversial'' proposals and make
the proposed rule change effective and operative upon filing. The
Commission believes that waiver of the five-day pre-filing notice and
the 30-day operative delay is consistent with the protection of
investors and the public interest. By waiving the five-day pre-filing
notice and the 30-day operative delay, the continued availability of
current Index values may be assured, notwithstanding any unavailability
of Bridge Data to calculate and disseminate those values. For this
reason, the Commission designates the proposal to be effective and
operative upon filing with the Commission.\14\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ For the purposes only of accelerating the operative date of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition and capital formation. 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 the 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-Phlx-2006-29 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2006-29. 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 inspection and
copying in the Commission's Public Reference Room. Copies of such
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-Phlx-2006-29 and should be submitted on or before June
29, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Lynn Taylor,
Assistant Secretary.
 [FR Doc. E6-8883 Filed 6-7-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: December 7, 2005 (Volume 70, Number 234)]
[Proposed Rules]
[Page 72740-72741]
[DOCID:fr07de05-17]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[R06-OAR-2005-TX-0030; FRL-8006-1]

Approval and Promulgation of Implementation Plans; Texas;
Revisions to Regulations for Control of Air Pollution by Permits for
New Sources and Modifications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The EPA proposes to approve revisions to the Texas State
Implementation Plan (SIP) which the Texas Commission on Environmental
Quality (TCEQ) submitted to EPA on February 5, 2004. The adopted
amendments revise minimum distance limitation permit requirements for
operation of new and modified sources to allow storage of an
inoperative concrete crusher within 440 yards of a residence, school,
or place of worship; define how distance measurements should be taken
and when they would be applicable to concrete crushers and other
facilities; and allow concrete crushers to recycle broken concrete at
temporary demolition sites within 440 yards of nearby buildings, unless
the facility is located in a county with a population of 2.4 million or
more, or in a county adjacent to such a county. The TCEQ also revised
the existing distance limitation for hazardous waste management
facilities to cross-reference duplicative language elsewhere in its
regulations. This action is being taken under section 110 of the
Federal Clean Air Act (the Act, or CAA).

DATES: Written comments must be received on or before January 6, 2006.

ADDRESSES: Comments may be mailed to Mr. David Neleigh, Chief, Air
Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Comments may also be
submitted electronically or through hand delivery/courier by following
the detailed instructions in the Addresses section of the direct final
rule located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Stanley M. Spruiell, Air Permits
Section (6PD-R), Environmental Protection Agency, Region 6, 1445 Ross
Avenue, Suite 700, Dallas, Texas 75202-2733, telephone<PHONE_NUMBER>;
fax number<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action
rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule

based on this proposed rule. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
    For additional information, see the direct final rule which is
located in the ``Rules and Regulations'' section of this Federal
Register.

    Dated: November 30, 2005.
Carl E. Edlund,
Acting Regional Administrator, Region 6.
[FR Doc. 05-23718 Filed 12-6-05; 8:45 am]

BILLING CODE 6560-50-P