UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES WASHINGTON, D. C. 20460 This revised report reflects a change from the previous HIARC report only in the selection of long term dermal and inhalation end points and identification of datagaps. No other changes were made.

HED DOC. NO. 014466 DATE: February 8, 2001 MEMORANDUM SUBJECT: DINOCAP  Report # 2 of the Hazard Identification Assessment Review Committee.

FROM: Paul Chin, Ph. D. Reregistration Branch I Health Effects Division ( 7509C)

THROUGH: Jess Rowland, Co Chair and Elizabeth Doyle, Co Chair Hazard Identification Assessment Review Committee Health Effects Division ( 7509C)

TO: William Hazel, Risk Assessor Reregistration Branch I Health Effects Division ( 7509C)

PC Code: 036001 On December 1, 1999, the Health Effects Division's Hazard Identification Assessment Review Committee ( HIARC) evaluated the toxicology database of dinocap and selected the toxicological endpoints for acute and chronic dietary, occupational, and residential ( dermal and inhalation) exposure risk assessments ( Report dated Feb. 23, 2000, HED Doc. # 014006).

At the HIARC meeting ( Dec. 1, 1999), it was reported that there was no long term dermal or inhalation exposure based on the current use pattern. However, the only dinocap use still registered in the U. S. is the use on ornamentals in greenhouses. Such uses often result in long term occupational exposure. Therefore, on December 19, 2000, the HIARC revisited dinocap to select long term dermal and long term inhalation endpoints for risk assessment purposes. 2 Committee Members in Attendance Members present were: William Burnam, Elizabeth Doyle, Pamela Hurley, Elizabeth Mendez, Yung Yang, Jess Rowland, Ayaad Assaad, Jonathan Chen and Brenda Tarplee.

Member in an absentia: David Nixon.

Data evaluation prepared by: Paul Chin, Reregistration Branch I.

Also, in attendance were: William Hazel and Whang Phang, RRB1.

Data Evaluation/ Report Presentation Paul Chin Toxicologist 3 1. INTRODUCTION On December 1, 1999, the Health Effects Division's Hazard Identification Assessment Review Committee ( HIARC) evaluated the toxicology database of dinocap and selected the toxicological endpoints for acute and chronic dietary, occupational, and residential ( dermal and inhalation) exposure risk assessments ( Report dated Feb. 23, 2000, TXR # 014006).

At the HIARC meeting ( Dec. 1, 1999), it was reported that there was no long term dermal or inhalation exposure based on the current use pattern. However, the only dinocap use still registered in the U. S. is the use on ornamentals in greenhouses. Such uses often result in long term occupational exposure. Therefore, on December 19, 2000, the HIARC revisited dinocap to select long term dermal and long term inhalation endpoints for risk assessment purposes.

The Health Effects Division ( HED) FQPA Safety Factor Committee met on March 13, 2000 to evaluate the hazard and exposure data for dinocap and recommended that the FQPA safety factor ( as required by the Food Quality Protection Act of August 3, 1996) be retained at 10x when assessing the risks posed from the use of this pesticide ( HED DOC. # 014071).

2. HAZARD IDENTIFICATION 2.1 Acute Reference Dose ( RfD)

2.1.1 Subpopulation ( Females 13+)

Study Selected: Developmental Toxicity Study in Mice Guideline #: 83 3( a)

MRID No.: 41313001 Executive Summary:

In a developmental toxicity study ( MRID No. 41313001), Dinocap ( 94.4% a. i.) suspension in an aqueous 1% Tragacanth Gum was administered by gavage to CD 1 ( ICR) BR mice ( 24/ dose) at 0, 4, 10 or 25 mg/ kg/ day from gestation days 6 through 15. One group of 12 presumed pregnant females underwent caesarean section while the other 12 pregnant females were allowed to deliver naturally.

There were no maternal deaths. No clinical signs or post mortem observations were attributed to test article administration. Although not statistically significant, the body weight in the high dose animals ( 25 mg/ kg/ day) was 5% lower than the controls on day 18 of gestation. In this group, the body weight gains were 7 and 11% lower than the controls from gestation days 6 15 and 0 18, respectively. The NOAEL for maternal toxicity is 10 mg/ kg/ day; the LOAEL is 25 mg/ kg/ day based on the slight decrease in body weight and body weight gains. 4 Although not statistically significant, dinocap at 25 mg/ kg/ day caused the following: reduction in numbers of corpora lutea, implantation size, litter size, and the percent of dams with any resoprtions. The number of total resorption and dead or resorbed conceptuses/ litter in the high dose animals were increased ( p< 0.05) when compared to the controls. In addition, dinocap at 25 mg/ kg/ day caused the following when compared to the controls: reduction in live fetal body weights ( 29% less than the controls, p< 0.01); increased incidence of cleft palate ( p< 0.01), " eye lids open" ( p< 0.01), and head tilt; and an effect on swimming performance ( p< 0.01) ( as measured by mice which sank and required rescue or swam on their side).

In the 10 mg/ kg/ day group, the number of total resorption was increased ( p< 0.05) and live fetal body weights were decreased ( 7% lower than the controls, p< 0.05). However, these differences from control groups are considered to be of little or no toxicological significance. In the 10 mg/ kg/ day group, in addition, a slight ( non significant) increased incidences in cleft palate and eyelids open occurred relative to the control group. Due to the absence of any occurrence in either concurrent or historical controls, the NOAEL is set conservatively at 4 mg/ kg/ day.

Natural delivery data showed that viability index, number of live precull on day 4 divided by number of live on day 1, was decreased ( p< 0.01) at 25 mg/ kg/ day ( 87% versus 97 100%) in the control and two lower dose groups. Lactation index was reduced ( p< 0.01) in the 4 mg/ kg/ day group only. However, this was primarily due to 8 pups from one litter dying by day 7 of weaning.

The NOAEL for developmental toxicity is 4 mg/ kg/ day; the LOAEL is 10 mg/ kg/ day based on the slight ( non significant) increase in incidences of cleft palate and eyelids open relative to the controls.

This study is classified as ACCEPTABLE/ NONGUIDELINE and does not satisfy the guideline data requirement for a developmental study ( 83 3a) in mice. The study was designed to answer specific question ( the inner ear formation). The Agency requested that the registrant perform a " modified" developmental toxicity study in mice in order to elucidate developmental toxicity potential of purified dinocap ( Q. Bui of the Agency to D. Edwards, dated 10/ 19/ 88, Tox. Doc. No. 007457).

Dose and Endpoint for Risk Assessment: The NOAEL for developmental toxicity is 4 mg/ kg/ day; the LOAEL is 10 mg/ kg/ day based on the slight ( non significant) increase in incidences of cleft palate and eyelids open relative to the controls.

Uncertainty Factor( s): An uncertainty factor of 100 was applied to account for inter species extrapolation ( 10 x) and intra species variability ( 10 x).

Comments about Study/ Endpoint/ Uncertainty Factor( s): This endpoint is appropriate for females 13+ subpopulation only since the end point is an in utero affect. 5 There is evidence to suggest that purified dinocap ( 94.4% a. i.) is a developmental toxicant in mice at doses which were not maternally toxic ( see executive summary described above). However, technical dinocap ( 84% a. i.) is also a developmental toxicant in mice at doses which were maternally toxic ( Rogers J. M. et al. 1986, EPA's Developmental Biology Division/ HERL. The doses used in this study were 5, 10, 20, 40, 80, and 120 mg/ kg/ day. There were no live fetuses at the 120 mg/ kg dose level. Dose related decreases in gravis uterus weight and fetal weight were significant at all remaining doses of dinocap. Cleft palate was found in fetuses at 5 ( 0.4%), 20 ( 23.6%), 40 ( 75.7%), and 80 ( 74.1%) mg/ kg/ day. There was also a dose related increase in supernumerary ribs, but a low frequency of exencephaly and umbilical hernia at high doses. The developmental toxicity potential of dinocap was thus demonstrated at doses well below those causing maternal toxicity ( LOAEL = 80 mg/ kg as characterized by significant decrease in weight gain) ( HED Doc. 007456, Nov 25, 1987). The LOAEL for developmental toxicity is < 5 mg/ kg/ day ( LDT).

Since the new formulation is the technical product with 92.2% a. i., the HIARC selected the study conducted with the new formulation.

ACUTE RfD ( females 13+) : 4 mg/ kg ( NOAEL) = 0.04 mg/ kg 100 ( UF)

2.1.2 General Population Dose and Endpoint for Risk Assessment: No appropriate endpoint was identified for this population group because there were no effects attributable to a single dose was identified in oral toxicology studies including developmental toxicity studies in mice and rabbits.

2.2 Chronic Reference Dose ( RfD)

The following RfD was established in 1994.

Study Selected: Chronic Feeding Study  Dog Guideline #: 83 1b Accession No.: 247957 Executive Summary:

In a chronic toxicity study ( Accession No. 247957), technical dinocap ( 78% a. i.) was administered to Beagle dogs ( 4/ sex/ dose) in the diet at levels of 0, 15, 60 or varying levels of 120 240 ppm ( 0, 0.375, 1.5 or 3 6 mg/ kg/ day based on a conversion factor of 1 ppm = 0.025 mg/ kg/ day) for 2 years. [ The test compound in the high dose group was fed at 240 ppm for 1 week, removed completely from the diet and restarted at 120 ppm for 4 30 weeks, increased again to 240 ppm for 11 days, removed completely, and then restarted at 180 ppm 6 for 33 61 weeks.]

Treatment of dogs with varying levels of 120 240 ppm of dinocap was lethal. Four dogs ( 2 males and 2 females) died during the first 43 weeks. One died from unexplained causes and the other 3 deaths were related to dinocap treatment. The remaining 4 dogs had significant reduction in body weights and food consumption and they were sacrificed during week 62 because of weight loss and poor condition. Other compound related effects included occasional ataxia and clonic convulsions, salivation, decreased activity, and rapid and labored respiration.

Ocular examination revealed changes in the tapetum, retina and ocular disc of all 4 high level dogs examined ( 4 died before examination) and 6/ 8 of these dogs had histologic retinal atrophy.

The only treatment related effects noted in dogs fed 60 ppm of dinocap were ophthalmoscopic changes in 7/ 8 dogs and histologic retinal atrophy in 3/ 8 dogs.

Levels of 15 and 60 ppm of dinocap did not have an effect on oxidative phosphorylation in liver mitochondria; mitochondria from dogs in the high level were not tested.

Under the conditions of this study, dinocap did not significantly affect hematology, clinical chemistry parameters, and cholinesterase activity of plasma, RBC or brain at 15 and 60 ppm. Due to poor conditions of the high dose animals the certain clinical chemistry parameters such as albumin and globulin levels were affected.

The NOAEL for systemic toxicity is 15 ppm ( 0.375 mg/ kg/ day); the LOAEL is 60 ppm ( 1.5 mg/ kg/ day) based on ophthalmoscopic changes and histologic retinal atrophy.

This chronic feeding study in dogs is classified as Acceptable/ guideline and satisfies the guideline data requirement for a chronic toxicity study ( 83 1b) in dogs.

Dose and Endpoints for Risk Assessment: The Systemic Toxicity NOAEL = 0.375 mg/ kg/ day and LOAEL = 1.5 mg/ kg/ day in male dogs, based on ophthalmoscopic changes and histologic retinal atrophy.

Uncertainty Factor( s): An uncertainty factor of 100 is proposed to account for inter species extrapolation ( 10X) and intra species variability ( 10X).

Comments about Study/ Endpoint/ Uncertainty Factor( s): The endpoint was selected from the chronic dog study because dogs appear to be more sensitive species than rats or mice. Although this dog chronic study was conducted with dinocap with 78% a. i., the endpoint was selected from this because no dog chronic study is available with new formulation ( 92% a. i.).

Chronic RfD = 0.375 mg/ kg/ day ( NOAEL) = 0.00375 mg/ kg/ day 100 ( UF) 7 2.3 Occupational / Residential Exposure 2.3.1 and 2.3.2 Short Term ( 1 7 days) and Intermediate Term ( 7 Days to Several Months) Incidental Oral Exposure No endpoint selection is required for this exposure period since this chemical is not registered for residential use and incidental oral exposure is not expected to occur.

2.3.3 Dermal Absorption Study Selected: Dermal Penetration Study in Monkey Guideline #: 85 2 Accession No.: 260614 Executive Summary:

In a dermal penetration study ( Accession No. 260614), 14C ring labeled dinocap ( 94% a. i.) was dermally applied to female Rhesus monkeys ( 4/ dose) at the rate of 40 ( group 2a: waterwash 40 ( group 2b: ethanol wash) and 2500 ( group 3: ethanol wash) ug/ cm2 for 6 hours. The application area was 40, 40 and 0.64 cm2 for groups 2a, 2b and 3, respectively. Six hours after dermal exposure, the application site was washed with water saturated cotton balls ( group 2a) or ethanol laden cotton balls followed by water laden cotton balls ( groups 2b and 3).

The recovery of radioactivity in 4 days following 6 hours exposure to 40 ( water wash), 40 ( ethanol wash), and 2500 ( group 3: ethanol wash) ug/ cm2 was 10.3, 5.1, and 2.6% of the applied dose in urine and 3.9, 7.3, and 1.6% of the dose in feces, respectively.

The recovery of radioactivity in dermal wash samples after 6 hours exposure to 40 ( waterwash 40 ( ethanol wash), and 2500 ( group 3: ethanol wash) ug/ cm2 was 17.5, 40.7, and 75.2% of the applied dose, respectively. The recovery data indicated that the use of ethanol as washing solution ( groups 2b and 3) apparently was more effective in removing the test chemical from the application site than water.

Total recovery of radioactivity in dermal wash samples and excreta ( urine and feces) in 4 days following 6 hours exposure to 40 ( water wash), 40 ( ethanol wash), and 2500 ( group 3: ethanol wash) ug/ cm2 was 49.28, 71.72, and 84.94% of the applied dose, respectively. [ Note: Some radiolabel may still be retained at the original application site. However, amounts of dose remained on the skin were not measured.]

An additional excretion study of dinocap in four monkeys was conducted after a single intravenous administration of 14C ring labeled dinocap at 0.2 mg/ kg. The recovery of radioactivity in the urine and feces were 49.2 and 35.3% of the injected dose in 4 days, respectively. 8 Dermal absorption of dinocap in 4 days following 6 hours exposure to 40 ( water wash group), 40 ( ethanol wash group) and 2500 ug/ cm2 ( ethanol wash group) was 42.4, 20.9, and 10.6% of the applied dose, respectively, using the following equation:

Dermal absorption = 14C urinary excretion ( dermal) x 100 14C urinary excretion ( i. v.)

This study is classified as acceptable/ guideline and satisfies the guideline data requirement for a dermal penetration study ( 85 2) in monkeys.

Dermal Absorption Factor: 42.4% in 4 days following 6 hours exposure. Washing skin with water is normally done. Ethanol washing may not be appropriate in the field situation. Therefore, water wash group is preferred over ethanol wash groups.

Comments about Dermal Absorption:

From the above monkey dermal absorption study, HIARC selected 4 day excretion data instead of one day excretion data because the experimental approach utilized to determine dermal absorption preclude estimation of dermal absorption after one day. Estimation of dermal absorption using 4 day excretion data reflect proper correction for urinary excretion of dinocap following i. v. dosing.

There is a dermal penetration study ( Accession No. 259639) in rabbits. This study showed that dermal absorption of dinocap ( expressed as % of applied dose) in 4 days following 6 hours exposure to 14C dinocap at 25, 100, and 220 mg/ kg varied from 3.8% ( applied neat at 25 mg/ kg) to 9.2% ( wettable dust formulation at 25 mg/ kg). This study would be useful when considering the possible exposure to the wettable dust formulation.

Because the permeability characteristics of monkey skin are closer to human than the rabbit, the monkey dermal absorption data is preferred over rabbit data.

2.3.4 Short Term Dermal ( 1  7 days) Exposure Study Selected: Developmental Toxicity Study in Mice Guideline #: 83 3( a)

MRID No.: 41313001 Executive Summary: See Acute Dietary.

Dose and Endpoint for Risk Assessment: The NOAEL for developmental toxicity is 4 mg/ kg/ day; the LOAEL is 10 mg/ kg/ day based on the slight ( non significant) increase in incidences of cleft palate and eyelids open relative to the controls.

Comments about Study/ Endpoint: Although a dermal developmental toxicity study in mice is available, the HIARC selected the oral study in mice because of the concern for the developmental effects seen at lower doses, via the oral route in two studies ( LOAEL = 10 9 mg/ kg/ day; < 5 mg/ kg/ day) compared to the dermal study ( LOAEL = 100 mg/ kg/ day).

In addition, the endpoint was selected from the mouse developmental toxicity study because mice appear to be more sensitive species than rats or rabbits.

Also, the endpoint selection from mouse developmental toxicity is supported by a dermal developmental study in rabbits ( ACCESSION Nos. 256934 and 259645). In this study, dinocap ( 87.8% a. i.) was dermally applied at concentrations of 0, 25, 50, or 100 mg/ kg/ day to presumed pregnant New Zealand white rabbits ( 18/ dose) on gestation days ( GDs) 7 through 19. Does were sacrificed on GD 29. The NOAEL for maternal toxicity is 50 mg/ kg/ day; the LOAEL is 100 mg/ kg/ day based on decreased body weights and food consumption. The NOAEL for developmental toxicity is 50 mg/ kg/ day; the LOAEL is 100 mg/ kg/ day based on increased litter and fetal incidences of skull bone islands and accessory skull bones and decreased fetal weight.

2.3.5 Intermediate Term Dermal ( 1 Week to Several Months) Exposure Study Selected: Mouse developmental toxicity study Guideline #: 83 3 ( a)

MRID No.: 41313001 Executive Summary: See Short term.

Dose and Endpoint for Risk Assessment: The NOAEL for developmental toxicity is 4 mg/ kg/ day; the LOAEL is 10 mg/ kg/ day based on the slight ( non significant) increase in incidences of cleft palate and eyelids open relative to the controls.

Comments about Study/ Endpoint: See short term.

2.3.6 Long Term Dermal ( Several Months to Lifetime) Exposure Study Selected: Chronic Feeding Study  Dog Guideline #: 83 1b Accession No.: 247957 Executive Summary: see Chronic Dietary Dose and Endpoint for Risk Assessment:

The Systemic Toxicity NOAEL = 0.375 mg/ kg/ day and LOAEL = 1.5 mg/ kg/ day in male dogs, based on ophthalmoscopic changes and histologic retinal atrophy.

Comments about Study/ Endpoint:

This dose/ endpoint was also used to derive the chronic RfD. 10 2.3.7 Inhalation Exposure ( All Duration)

Except for an acute inhalation toxicity study, the results of which place DINOCAP in Toxicity Category III ( LC50 = 0.9 mg/ L), no other studies are available via this route. Therefore, the HIARC selected the oral NOAELs of 4 mg/ kg/ day from developmental toxicity study in mice for Short Term and Intermediate Term inhalation risk assessments. For Long term risk assessment, the HIARC selected the oral NOAEL of 0.375 mg/ kg/ day from the chronic feeding study in dogs. Since an oral value is selected, route to route extrapolation should be as follows.

When route to route extrapolations is recommended: 1) convert the inhalation exposure (: g/ lb a. i) and the dermal exposure ( mg/ lb a. i) to oral equivalent doses ( mg/ kg); 2) combine the converted oral equivalent doses to get a combined dose for total ( dermal + inhalation) exposure; and 3) this combined dose should then be compared with the oral NOAEL to calculate the Margins of Exposure.

2.3.8 Margins of Exposures for Occupational/ Residential Risk Assessments A MOE of 100 is adequate for occupational exposure and the MOEs for residential ( dermal and inhalation) exposure are 1000 as determined during risk characterization by the FQPA Safety Factor Committee.

2.4 Recommendation for Aggregate Exposure Risk Assessments For acute aggregate exposure risk assessment, combine the high end exposure values from food + water and compare it to the acute RfD.

For short, intermediate, and long term aggregate exposure risk assessment, combine the average values from food + water together with short or intermediate dermal ( corrected for % DA) + short or intermediate inhalation ( corrected for % IA) exposure and compared to the oral NOAEL ( oral equivalent doses were selected for dermal and inhalation exposures).

3. CLASSIFICATION OF CARCINOGENIC POTENTIAL The HED RfD/ Peer Review Committee ( HED Doc. No. 011076 dated June 24, 1994) considered that the carcinogenicity phase of the rat study ( MRID No. 41065401 and ACCESSION No. 00247959) and the carcinogenicity study in mice ( MRID Nos. 418639801, 42079102) were considered to be adequate. The high dose levels tested in both rats and mice were considered to be adequate for carcinogenicity testing. The treatment did not alter the spontaneous tumor profile in either animal species. In accordance with the 1986 Cancer Risk Assessment Guideline, dinocap is placed in " Group E"; non carcinogenic to humans. 11 4. MUTAGENICITY Dinocap was negative for inducing mutations in all acceptable guideline studies of the standard battery of mutagenicity tests except for Ames studies. In Ames studies, dinocap was weakly positive at best and limited to high doses. These studies satisfy mutagenicity testing requirements.

5. FQPA CONSIDERATIONS The Health Effects Division ( HED) FQPA Safety Factor Committee met on March 13, 2000 to evaluate the hazard and exposure data for dinocap and recommended that the FQPA safety factor ( as required by the Food Quality Protection Act of August 3, 1996) be retained at 10x when assessing the risks posed from the use of this pesticide ( HED DOC. NO. 014071).

6. HAZARD CHARACTERIZATION The toxicity data indicate that dinocap has low acute oral, dermal and inhalation toxicity. It is a skin sensitizer. It causes moderate eye and skin irritation. The chronic feeding toxicity study in rats demonstrated that dinocap induced liver toxicity ( increased relative liver weights and slight to moderate panlobular hepatocellular hypertrophy) and thyroid toxicity ( increased incidences of thyroid follicular cell hypertrophy and altered colloid). The chronic feeding toxicity study in dogs demonstrated that dinocap induced ophthalmoscopic changes and histologic retinal atrophy. The carcinogenicity data showed that carcinogenic potential was not exhibited by dinocap in rats and mice.

Dinocap produced developmental toxicity in mice and rabbits and it did not affect reproductive parameters in rats. Dinocap was negative for inducing mutations in all acceptable guideline studies of the standard battery of mutagenicity tests except for Ames studies. In Ames studies, dinocap was weakly positive at best and limited to high doses.

Dermal absorption studies showed that dermal absorption of dinocap ( expressed as % of applied dose) in 4 days following 6 hours exposure to 14C dinocap was 42.4% and 9.2% in monkeys and rabbits, respectively.

There is high confidence in the chronic RfD of 0.00375 mg/ kg/ day. This was based on the NOAEL of 0.375 mg/ kg/ day from the chronic study in dog and uncertainty factor of 100. The LOAEL for 1.5 mg/ kg/ day in male dogs was based on ophthalmoscopic changes and histologic retinal atrophy. The database is adequate to evaluate FQPA assessment and consists of developmental studies in the mice and rabbits, and a two generation reproduction study in the rats. Based on the findings in the developmental toxicity study in mice and rabbits, there appears to be an increased severity of effects noted in the offspring at maternally toxic doses. In addition, neurotoxicity in the form of clinical signs [ such as swimming behavior abnormalities characterized by torticollis condition consistent with malformation of the inner ear ( absence of otoliths)] was observed in the developmental toxicity study in rats. Also, ophthalmoscopic changes and histologic retinal atrophy was observed in the chronic study in dogs. In addition, a 30 month chronic/ carcinogenicity study in rat ( 1980 study) 12 showed an increased incidence of degeneration/ atrophy of the calf muscle in the mid and high dose ( 10 and 100 mg/ kg/ day) females and degeneration/ atrophy of the sciatic nerve in the high dose ( 100 mg/ kg/ day) males and females ( MRID No. 41065401; Accession No. 247959).

7. DATA GAPS Acute and subchronic neurotoxicity studies in rats and a developmental neurotoxicity study in rats have been recommended by the HIARC. In addition, due to the potential of long term inhalation exposure the HIARC recommended a 90 day inhalation toxicity study in rats to address the concerns for assessing risks posed to workers ( greenhouse use) by this route. 13 8 ACUTE TOXICITY Acute Toxicity of Dinocap Guideline No. Study Type MRID No. RESULTS TOXICITY CATEGORY 870.1100 Acute Oral  Rat 42124301 LD 50 = > 500 and 5,000 mg/ kg ( both sexes) III 870.1200 Acute Dermal  Rabbit 42124302 LD50 => 5,000 mg/ kg IV 870.1300 Acute Inhalation  Rat 42124303 LC50= 0.9 mg/ L III 870.2400 Eye Irritation Rabbit 42124304 moderate irritation; Corneal and conjunctival effects at 24 hours; corneal effects cleared by day 2 and conjunctival effects cleared by day 7. III 870.2500 Dermal Irritation Rabbit 42124305 moderate irritation at day 3 and cleared by day 14. III 870.2600 Dermal sensitization  Guinea pig 42124306 a sensitizer N/ A 14 9 SUMMARY OF TOXICOLOGY ENDPOINT SELECTION The doses and toxicological endpoints selected for various exposure scenarios are summarized below.

EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Acute Dietary ( Female 13+) NOAEL= 4 slight ( non significant) increase in incidences of cleft palate and eyelids open Developmental   mouse UF= 100 Acute RfD = 0.04 mg/ kg/ day Acute Dietary ( General population) An appropriate endpoint attributable to a single dose was not identified.

Chronic Dietary NOAEL= 0.375 ophthalmoscopic changes and histologic retinal atrophy Chronic feeding   dog UF= 100 Chronic = 0.00375 mg/ kg/ day Incidental Oral, Short and Intermediate Term No endpoint selection is required for this exposure period since this chemical is not registered for residential use and incidental oral exposure is not expected to occur.

Short Term ( a)

( Dermal) oral NOAEL= 4 slight ( non significant) increase in incidences of cleft palate and eyelids open Developmental   mouse Intermediate Term ( Dermal) oral NOAEL= 4 slight ( non significant) increase in incidences of cleft palate and eyelids open Developmental   mouse Long Term ( Dermal) oral NOAEL= 0.375 ophthalmoscopic changes and histologic retinal atrophy Chronic feeding   dog Inhalation ( short & intermediate) ( b) oral NOAEL= 4 slight ( non significant) increase in incidences of cleft palate and eyelids open Developmental   mouse Inhalation ( long) oral NOAEL= 0.375 ophthalmoscopic changes and histologic retinal atrophy Chronic feeding   dog a = Since an oral NOAEL was selected, a dermal absorption factor of 42% should be used in route to route extrapolation. b = Since an oral NOAEL was selected, an inhalation absorption factor of 100% ( default value) should be used in route to route extrapolation. C:\ 1 new file\ dinocap\ hazid. final. pc036001 2/ 7/ 2001


[Federal Register Volume 79, Number 45 (Friday, March 7, 2014)]
[Notices]
[Pages 13086-13087]
[FR Doc No: 2014-04977]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2013-0192]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 46 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions will enable these individuals to operate CMVs in
interstate commerce.

DATES: The exemptions are effective March 7, 2014. The exemptions
expire on March 7, 2016.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room
W64-224, Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316).

Background

    On December 26, 2013, FMCSA published a notice of receipt of
Federal diabetes exemption applications from

46 individuals and requested comments from the public (78 FR 78479).
The public comment period closed on January 27, 2014, and one comment
was received.
    FMCSA has evaluated the eligibility of the 46 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 46 applicants have had ITDM over a range of 1 to 23 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the December 26, 2013, Federal
Register notice and they will not be repeated in this notice.

Discussion of Comments

    FMCSA received one comment in this proceeding. The comment is
discussed and considered below.
    Antonio A. Sena expressed his thanks and appreciation to the FMCSA
staff for their help and guidance throughout the application process.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

Conclusion

    Based upon its evaluation of the 46 exemption applications, FMCSA
exempts William B. Andrus (AL), Chad E. Anger (WI), Thomas C. Aston
(MD), Jared F. Beard (ND), Edward Blake (GA), Jerrel F. Bower (MO),
Jerry A. Campbell (OH), Brian M. Chase (VA), Charles R. Clayton (NJ),
Phillip Covel (NE), Ariel Cuevas (NJ), Glen C. Davis (TN), Nicholas P.
Dube (RI), Arthur W. Ehrenzeller (PA), Manuael Elizondo (TX), Michael
K. Farris (IN), Merino Fernandes (IL), Craig J. Gadley, Sr. (NY),
Daniel Grove, Jr. (PA), Mary F. Guilfoy (IN), James M. Hatcher (MS),
Edward S. Ionescu (IL), Jeffrey James (AK), Hayward S. Mason (NY), Guy
B. Mayes (WA), Ashun R. Merritt (GA), Herbert A. Morton (CA), Colby A.
Nutter (VA), Jayrome D. Rimolde (MN), Gale Roland (PA), Larry J.
Sanders (MD), Kelly T. Scholl (MN), Antonio A. Sena (CA), Gregory G.
Sisco (IA), Travers L. Stephens (GA), Brittany K. Tomasko (CA), Johnny
G. Wallace (AR), Daren Warren (NY), Aaron E. Webb (WA), Billy J. Webb,
Jr. (MS), Alan T. Whalen (NY), Thomas L. Whitley (IN), Randall S.
Williams (PA), Tomme J. Wirth (IA), Charles J. Wirth (WI), Thomas A.
Wysocki (NJ) from the ITDM requirement in 49 CFR 391.41(b)(3), subject
to the conditions listed under ``Conditions and Requirements'' above.
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will
be valid for two years unless revoked earlier by FMCSA. The exemption
will be revoked if the following occurs: (1) The person fails to comply
with the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: February 25, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-04977 Filed 3-6-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Rules and Regulations]
[Pages 26109-26112]
[FR Doc No: 2016-09650]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-1428; Directorate Identifier 2015-NM-026-AD;
Amendment 39-18499; AD 2016-09-01]
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 certain
The Boeing Company Model 777-200 and -300 series airplanes. This AD was
prompted by reports of fatigue cracking of a certain chord of the pivot
bulkhead. This AD requires repetitive inspections for cracking of the
left side and right side forward outer chords of the pivot bulkhead,
and related investigative and corrective actions if necessary. This AD
also provides a modification of the pivot bulkhead, which would
terminate the repetitive inspections. We are issuing this AD to detect
and correct fatigue cracking of the outer flanges of the left and right
side forward outer chords of the pivot bulkhead, which could result in
a severed forward outer chord and consequent loss of horizontal
stabilizer control.

DATES: This AD is effective June 6, 2016.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of June 6, 2016.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone:
206-544-5000, extension 1; fax:<PHONE_NUMBER>; Internet: https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
1428.

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-2015-
1428; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, 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: Narinder Luthra, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6513; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
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 777-200 and -300 series airplanes. The NPRM published in the
Federal Register on June 15, 2015 (80 FR 34103) (``the NPRM''). The
NPRM was prompted by reports of fatigue cracking of a certain chord of
the pivot bulkhead. The NPRM proposed to require repetitive inspections
for cracking of the left side and right side forward outer chords of
the pivot bulkhead, and related investigative and corrective actions if
necessary. The NPRM also proposed to provide a modification of the
pivot bulkhead, which would terminate the repetitive inspections. We
are issuing this AD to detect and correct fatigue cracking of the outer
flanges of the left and right side forward outer chords of the pivot
bulkhead, which could result in a severed forward outer chord and
consequent loss of horizontal stabilizer control.

Comments

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

Request To Exclude Certain Requirements From the NPRM

    American Airlines (AA) requested that we revise the NPRM to exclude
doing the work in accordance with paragraph 3.B.4., of the Work
Instructions of Boeing Alert Service Bulletin 777-53A0075, dated
January 14, 2015, which specifies ``Put the airplane back into a
serviceable condition.'' AA stated that doing this action does not
affect the condition that the AD seeks to address. AA added that most
operators will accomplish these modifications as part of a maintenance
visit, and returning the airplane to a serviceable condition will not
be possible in the context of the statement, but rather will occur at a
point in time well after the work is completed.
    We agree that putting the airplane back into a serviceable
condition is not directly related to addressing the unsafe condition
identified in this AD. However, we do not agree to specifically exclude
paragraph 3.B.4., of the Work Instructions of Boeing Alert Service
Bulletin 777-53A0075, dated January 14, 2015, from this final rule
because it is not required for compliance with the AD actions.
    The FAA worked in conjunction with industry, under the
Airworthiness Directives Implementation Aviation Rulemaking Committee
(AD ARC), to enhance the AD system. One enhancement is a new process
for annotating which steps in the service information are ``required
for compliance'' (RC) with an AD. Differentiating these steps from
other tasks in the service information is expected to improve an
owner's/operator's understanding of AD requirements and help provide
consistent judgment in AD compliance.
    In response to the AD Implementation ARC, the FAA released AC 20-
176A, dated June 16, 2014 (http://rgl.faa.gov/
Regulatory_and_Guidance_Library/rg

AdvisoryCircular.nsf/0/979ddd1479e1ec6f86257cfc0052d4e9/$FILE/AC%2020-
176A.pdf); and Order 8110.117A, dated June 18, 2014 (http://
rgl.faa.gov/Regulatory_and_Guidance_Library/rgOrders.nsf/0/
d715cdfc08ac0ddc86257cfc00528297/$FILE/110.117A.pdf), which include the
concept of RC. The FAA has begun implementing this concept in ADs when
we receive service information containing RC steps.
    Boeing Alert Service Bulletin 777-53A0075, dated January 14, 2015,
includes the concept of RC. In paragraph 3.B. of the Work Instructions
of Boeing Alert Service Bulletin 777-53A0075, dated January 14, 2015,
certain steps are marked RC. The step that specifies ``Put the airplane
back into a serviceable condition'' is not marked RC. Therefore, no
change to this final rule is necessary in this regard.

Request To Change Certain Language in the NPRM

    Boeing and United Airlines (UA) asked that the language in
paragraph (h) of the proposed AD be reworded for clarity. Boeing asked
that we account for the small crack repair being performed on one side
only. UA stated that as written, inspecting the left side and right
side forward outer chords is incorrect since the small crack repair is
performed on one side only. UA noted that the small crack repair may be
accomplished on one side of the airplane only, depending on inspection
findings. UA asked that paragraph (h) of the proposed AD be changed to
specify ``. . . do a surface high frequency eddy current (HFEC)
inspection, an open-hole HFEC inspection, and a detailed inspection for
cracking of the repaired side (left, right, or both) forward outer
chords of the STA 2370 pivot bulkhead.'' Boeing recommended that the
language be reworded to specify an ``. . . inspection for cracking of
the repaired forward outer chords . . .''
    We agree with the commenters' requests for the reasons provided. We
have changed the language in paragraph (h) of this AD to specify ``. .
. do a surface HFEC inspection, an open-hole HFEC inspection, and a
detailed inspection for cracking of the repaired side forward outer
chords of the STA 2370 pivot bulkhead.''
    Boeing and UA asked that the language in paragraph (i) of the
proposed AD be reworded for clarity. Boeing asked that we account for
the scenario where the small crack repair is performed on one side
only. Boeing stated that the terminating actions for each side of the
bulkhead are independent of each other. UA stated that using ``and'' is
incorrect because the modification can only be accomplished on one
side, not both the left and right sides, depending on inspection
findings.
    We agree with the commenters for the reasons provided. We have
changed the language in paragraph (i) of this AD accordingly.

Request To Include Revised Service Information

    All Nippon Airways (ANA) stated that Boeing Alert Service Bulletin
777-53A0075, dated January 14, 2015; and Boeing Service Bulletin 777-
53-0076, dated January 14, 2015; contain many inconsistencies. We infer
that ANA is requesting that we include revised service information
because there are errors in the original issues.
    We agree with the commenter. Boeing has issued Boeing Alert Service
Bulletin 777-53A0075, Revision 1, dated December 14, 2015; and Boeing
Service Bulletin 777-53-0076, Revision 1, dated December 21, 2015;
which include changes found during validation and clarify and correct
issues identified by operators. We have included the revised service
information as the appropriate source of service information for
accomplishing the actions required by this AD and we have referred to
Boeing Alert Service Bulletin 777-53A0075, Revision 1, dated December
14, 2015, in the applicability in paragraph (c) of this AD. We have
also added a new credit paragraph (k) to this AD for using the original
issues of the service information and reidentified subsequent
paragraphs accordingly.

Request To Add a New Paragraph for Clarification

    Boeing asked that we add a new paragraph (j)(3) to the proposed AD
to specify the following:

    If conducting the Part 2 Small Crack Repair of the Service
Bulletin 777-53A0075 dated January 14, 2015, verify the fastener
heads and nuts will not interfere with the fillet radius of the
parts in the repair installation. If interference will occur, repair
before further flight using a method approved in accordance with the
procedures specified in paragraph (k) of this AD. . .

    Boeing also asked that we add a reference to paragraph (j)(3) in
paragraph (g) of the proposed AD by including it in the exception
sentence. Boeing stated that during a recent validation it was
discovered that, in some cases, radius fillers are required to prevent
fasteners from riding the fillet radius of the extended splice chord
used in the small crack repair specified in Part 2 of Boeing Alert
Service Bulletin 777-53A0075, dated January 14, 2015.
    We agree with the commenter that interference between the fastener
and fillet case should be minimized; however, we do not agree to add a
new paragraph (j)(3) to this AD. Boeing has issued Boeing Alert Service
Bulletin 777-53A0075, Revision 1, dated December 14, 2015, which
includes instructions for accomplishing the small crack repair. As
stated previously, we have revised this AD to refer to Boeing Alert
Service Bulletin 777-53A0075, Revision 1, dated December 14, 2015, for
accomplishing certain actions required by this AD.

Request To Correct Minor Error

    Boeing asked that we change the service information number
identified in paragraph (j)(2) of the proposed AD from ``777-530076''
to ``777-53-0076.''
    We agree that the hyphen is missing from the service information
number. We have included the hyphen in the service information number
identified in paragraph (j)(2) of this AD accordingly.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD 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 correcting 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 AD.

Related Service Information Under 1 CFR Part 51

    We reviewed the following Boeing service information.
     Boeing Alert Service Bulletin 777-53A0075, Revision 1,
dated December 14, 2015. This service information describes procedures
for repetitive detailed and HFEC inspections for cracking of the outer
flanges of the left and right side forward outer chords of the STA 2370
pivot bulkhead, repetitive post-repair inspections for certain
airplanes, and related investigative and corrective actions.
     Boeing Service Bulletin 777-53-0076, Revision 1, dated
December 21, 2015. This service information describes procedures for a
modification of the STA 2370 pivot bulkhead by replacing the left and
right side forward outer chords and upper splice angles, and

related investigative and corrective 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 60 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
            Action                         Labor cost             Parts cost  Cost per product      operators
----------------------------------------------------------------------------------------------------------------
Inspections of left and right   Up to 15 work[dash]hours x $85            $0  Up to $1,275 per  Up to $76,500
 side pivot bulkhead forward     per hour = $1,275 per                         inspection        per inspection
 chord.                          inspection cycle.                             cycle.            cycle.
Post-repair Inspections.......  Up to 11 work[dash]hours x $85             0  Up to $935 per    Up to $56,100
                                 per hour = $935 per inspection                inspection        per inspection
                                 cycle.                                        cycle.            cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary repairs and
modifications that would be required based on the results of the
inspection. We have no way of determining the number of airplanes that
might need these actions.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
               Action                             Labor cost                 Parts cost       Cost per product
----------------------------------------------------------------------------------------------------------------
Small crack repair.................  Up to 45 work[dash]hours x $85 per               \1\  Up to $7,650.
                                      hour = $3,825 per side.
Modification of the STA 2370 Pivot   Up to 137 work[dash]hours x $85 per          $34,086  Up to $45,731.
 Bulkhead (forward outer chord        hour = $11,645.
 replacement).
----------------------------------------------------------------------------------------------------------------
\1\ We have received no definitive data that would enable us to provide parts cost estimates for the on-
  condition repair specified in this AD.

    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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.

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):

2016-09-01 The Boeing Company: Amendment 39-18499; Docket No. FAA-
2015-1428; Directorate Identifier 2015-NM-026-AD.

(a) Effective Date

    This AD is effective June 6, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200 and -300
series airplanes, certificated in any category, as identified in
Boeing Alert Service Bulletin 777-53A0075, Revision 1, dated
December 14, 2015.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by reports of fatigue cracking of the
forward outer chord of the station (STA) 2370 pivot bulkhead. We are
issuing this AD to detect and correct fatigue cracking of the outer
flanges of the left and right side forward outer chords of the STA
2370 pivot bulkhead, which could result in a severed forward outer
chord and consequent loss of horizontal stabilizer control.

(f) Compliance

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

(g) Inspections and Corrective Actions

    At the times specified in table 1 of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 777-53A0075,
Revision 1, dated December 14, 2015, except as provided in paragraph
(j)(1) of this AD: Do a detailed inspection and high frequency eddy
current (HFEC) inspections for cracking of the left and right side
forward outer chords of the STA 2370 pivot bulkhead, and do all
applicable related investigative and corrective actions, in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 777-53A0075, Revision 1, dated December 14, 2015,
except as provided in paragraph (j)(2) of this AD. Do all applicable
related investigative and corrective actions before further flight.
Repeat the inspections thereafter at the applicable intervals
specified in table 1 of paragraph 1.E., ``Compliance,'' of Boeing
Alert Service Bulletin 777-53A0075, Revision 1, dated December 14,
2015, until the modification specified in paragraph (i) of this AD
is done.

(h) Post-Repair Inspections

    For airplanes on which any repair specified in Part 2 of the
Accomplishment Instructions of Boeing Alert Service Bulletin 777-
53A0075 has been done: At the times specified in table 2 of
paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
777-53A0075, Revision 1, dated December 14, 2015, do a surface HFEC
inspection, an open-hole HFEC inspection, and a detailed inspection
for cracking of the repaired side forward outer chords of the STA
2370 pivot bulkhead, and do all applicable related investigative and
corrective actions, in accordance with Part 3 of the Accomplishment
Instructions of Boeing Alert Service Bulletin 777-53A0075, Revision
1, dated December 14, 2015, except as required by paragraph (j)(2)
of this AD. Do all applicable related investigative and corrective
actions before further flight. Repeat the inspections thereafter at
the applicable times specified in table 2 of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 777-53A0075,
Revision 1, dated December 14, 2015, until the modification
specified in paragraph (i) of this AD is done.

(i) Terminating Action

    Modifying the STA 2370 pivot bulkhead by replacing the left or
right side forward outer chords and upper splice angles, and doing
all applicable related investigative and corrective actions,
terminates the repetitive inspections required by paragraphs (g) and
(h) of this AD, for the modified location only. The modification
must be done in accordance with the Accomplishment Instructions of
Boeing Service Bulletin 777-53-0076, Revision 1, dated December 21,
2015, except as required by paragraph (j)(2) of this AD.

(j) Exceptions to Service Bulletin Specifications

    (1) Where Boeing Alert Service Bulletin 777-53A0075, Revision 1,
dated December 14, 2015, specifies a compliance time ``after the
Original Issue date of this Service Bulletin,'' this AD requires
compliance within the specified compliance time after the effective
date of this AD.
    (2) Although Boeing Alert Service Bulletin 777-53A0075, Revision
1, dated December 14, 2015; and Boeing Service Bulletin 777-53-0076,
Revision 1, dated December 21, 2015; specify to contact Boeing for
appropriate action, and Boeing Alert Service Bulletin 777-53A0075,
Revision 1, dated December 14, 2015, specifies that action as ``RC''
(Required for Compliance), this AD requires repair before further
flight using a method approved in accordance with the procedures
specified in paragraph (l) of this AD.

(k) Credit for Previous Actions

    (1) This paragraph provides credit for the actions required by
paragraphs (g) and (h) of this AD, if those actions were performed
before the effective date of this AD using Boeing Alert Service
Bulletin 777-53A0075, dated January 14, 2015.
    (2) This paragraph provides credit for the actions required by
paragraph (i) of this AD, if those actions were performed before the
effective date of this AD using Boeing Service Bulletin 777-53-0076,
dated January 14, 2015.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
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 ACO, send it to the
attention of the person identified in paragraph (m)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (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, Seattle ACO, 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.
    (4) Except as required by paragraph (j)(2) of this AD: For
service information that contains steps that are labeled as Required
for Compliance (RC), the provisions of paragraphs (l)(4)(i) and
(l)(4)(ii) apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. An AMOC is required for any deviations to RC steps,
including substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(m) Related Information

    (1) For more information about this AD, contact Narinder Luthra,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO,
1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (n)(3) and (n)(4) of this AD.

(n) 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 Service Bulletin 777-53A0075, Revision 1, dated
December 14, 2015.
    (ii) Boeing Service Bulletin 777-53-0076, Revision 1, dated
December 21, 2015.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-
5000, extension 1; fax:<PHONE_NUMBER>; Internet: https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (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 Renton, Washington, on April 14, 2016.
Victor Wicklund,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-09650 Filed 4-29-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58424-58428]
[FR Doc No: 2012-23178]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67859; File No. SR-ISE-2012-72]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend the Exchange's Schedule of Fees Regarding Complex Order
Rebates

September 14, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the

``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 4, 2012, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which items have been prepared by the
self-regulatory organization. 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.
---------------------------------------------------------------------------

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

    The ISE is proposing to amend its Schedule of Fees. The text of the
proposed rule change is available on the Exchange's Web site (http://www.ise.com), at the principal office of the Exchange, 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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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 Exchange currently assesses per contract transaction fees and
provides rebates to market participants that add or remove liquidity
from the Exchange (``maker/taker fees and rebates'') in a number of
options classes (the ``Select Symbols'').\3\ The Exchange's maker/taker
fees and rebates are applicable to regular and complex orders executed
in the Select Symbols and in the Special Non-Select Penny Pilot
Symbols.\4\ The Exchange also currently assesses maker/taker fees and
rebates for complex orders in symbols that are in the Penny Pilot
program but are not a Select Symbol (``Non-Select Penny Pilot
Symbols'') \5\ and for complex orders in all symbols that are not in
the Penny Pilot Program (``Non-Penny Pilot Symbols'').\6\
---------------------------------------------------------------------------

    \3\ Options classes subject to maker/taker fees and rebates are
identified by their ticker symbol on the Exchange's Schedule of
Fees.
    \4\ See Exchange Act Release Nos. 67201 (June 14, 2012), 77 FR
37082 (June 20, 2012) (SR-ISE-2012-49); and 67627 (August 9, 2012),
77 FR 49046 (August 15, 2012) (SR-ISE-2012-70).
    \5\ See Exchange Act Release No. 65724 (November 10, 2011), 76
FR 71413 (November 17, 2011) (SR-ISE-2011-72).
    \6\ See Exchange Act Release Nos. 66084 (January 3, 2012), 77 FR
1103 (January 9, 2012) (SR-ISE-2011-84); 66392 (February 14, 2012),
77 FR 10016 (February 21, 2012) (SR-ISE-2012-06); 66961 (May 10,
2012), 77 FR 28914 (May 16, 2012) (SR-ISE-2012-38); and 67400 (July
11, 2012), 77 FR 42036 (July 17, 2012) (SR-ISE-2012-63).
---------------------------------------------------------------------------

    The purpose of this proposed rule change is to amend the rebate
tiers and increase the rebate levels for complex orders in options on
the Select Symbols, the Non-Select Penny Pilot Symbols, the Non-Penny
Pilot Symbols and in options on one Select Symbol--SPY--which has a
distinct rebate tier and amount. The Exchange believes this proposed
rule change will enhance the Exchange's competitive position and
incentivize Members to increase the amount of Priority Customer complex
orders that they send to the Exchange in these symbols.
    In the Select Symbols, the Exchange currently provides a base
rebate of $0.34 per contract, per leg, for Priority Customer complex
orders when these orders trade with non-Priority Customer complex
orders in the complex order book. Additionally, Members can earn a
higher rebate amount by achieving certain average daily volume (ADV)
thresholds on a month-to-month basis. The current ADV threshold for the
base tier is 0-74,999 Priority Customer complex contracts. The Exchange
proposes to lower this threshold to 0-39,999 Priority Customer complex
contracts and the base rebate of $0.34 per contract, per leg, will now
apply to this tier. With the adoption of a new base tier, what was
previously the base tier is now the second tier. The ADV threshold for
this tier was previously 0-74,999 Priority Customer complex contracts.
The Exchange proposes to amend this threshold so that it is now 40,000-
74,999 Priority Customer complex contracts. The rebate amount for this
tier was previously $0.34 per contract, per leg. The Exchange proposes
to increase the rebate for this tier to $0.36 per contract, per leg.
With the adoption of a new base tier, what was previously the second
tier is now the third tier. The ADV threshold for this tier was
previously 75,000-124,999 Priority Customer complex contracts. The
Exchange is not proposing any change to the ADV threshold for this
tier. The rebate amount for this tier was previously $0.36 per
contract, per leg. The Exchange proposes to increase the rebate for
this tier to $0.37 per contract, per leg. With the adoption of a new
base tier, what was previously the third tier is now the fourth tier.
The ADV threshold for this tier was previously 125,000-249,999 Priority
Customer complex contracts. The Exchange proposes to amend this
threshold by lowering the top end of the range so that it is now
125,000-224,999 Priority Customer complex orders. The rebate amount for
this tier was previously $0.37 per contract, per leg. The Exchange
proposes to increase the rebate for this tier to $0.38 per contract,
per leg. Finally, with the adoption of a new base tier, what was
previously the fourth tier is now the fifth tier. The ADV threshold for
this tier was previously 250,000 or more Priority Customer complex
contracts. The Exchange proposes to amend this threshold by lowering it
so that it is now 225,000 or more Priority Customer complex contracts.
The rebate amount for this tier was previously $0.38 per contract, per
leg. The Exchange proposes to increase the rebate for this tier to
$0.39 per contract, per leg. The highest rebate amount achieved by the
Member for the current calendar month applies retroactively to all
Priority Customer complex order contracts that trade with non-Priority
Customer complex orders in the complex order book executed by the
Member during such calendar month.
    In the Non-Select Penny Pilot Symbols, the Exchange currently
provides a base rebate of $0.33 per contract, per leg, for Priority
Customer complex orders when these orders trade with non-Priority
Customer complex orders in the complex order book. Additionally,
Members can earn a higher rebate amount by achieving certain ADV
thresholds on a month-to-month basis. The current ADV threshold for the
base tier is 0-74,999 Priority Customer complex contracts. The Exchange
proposes to lower this threshold to 0-39,999 Priority Customer complex
contracts and the base rebate of $0.33 per contract, per leg, will now
apply to this tier. With the adoption of a new base tier, what was
previously the base tier is now the second tier. The ADV threshold for
this tier was previously 0-74,999 Priority Customer complex contracts.
The Exchange proposes to amend this threshold so that it is now 40,000-
74,999 Priority Customer complex contracts. The rebate amount for this
tier was previously

$0.33 per contract, per leg. The Exchange proposes to increase the
rebate for this tier to $0.34 per contract, per leg. With the adoption
of a new base tier, what was previously the second tier is now the
third tier. The ADV threshold for this tier was previously 75,000-
124,999 Priority Customer complex contracts. The Exchange is not
proposing any change to the ADV threshold for this tier. The rebate
amount for this tier was previously $0.34 per contract, per leg. The
Exchange proposes to increase the rebate for this tier to $0.36 per
contract, per leg. With the adoption of a new base tier, what was
previously the third tier is now the fourth tier. The ADV threshold for
this tier was previously 125,000-249,999 Priority Customer complex
contracts. The Exchange proposes to amend this threshold by lowering
the top end of the range so that it is now 125,000-224,999 Priority
Customer complex orders. The rebate amount for this tier was previously
$0.36 per contract, per leg. The Exchange proposes to increase the
rebate for this tier to $0.37 per contract, per leg. Finally, with the
adoption of a new base tier, what was previously the fourth tier is now
the fifth tier. The ADV threshold for this tier was previously 250,000
or more Priority Customer complex contracts. The Exchange proposes to
amend this threshold by lowering it so that it is now 225,000 or more
Priority Customer complex contracts. The rebate amount for this tier
was previously $0.37 per contract, per leg. The Exchange proposes to
increase the rebate for this tier to $0.38 per contract, per leg. The
highest rebate amount achieved by the Member for the current calendar
month applies retroactively to all Priority Customer complex order
contracts that trade with non-Priority Customer complex orders in the
complex order book executed by the Member during such calendar month.
    In the Non-Penny Pilot Symbols, the Exchange currently provides a
base rebate of $0.66 per contract, per leg, for Priority Customer
complex orders when these orders trade with non-Priority Customer
complex orders in the complex order book. Additionally, Members can
earn a higher rebate amount by achieving certain ADV thresholds on a
month-to-month basis. The current ADV threshold for the base tier is 0-
74,999 Priority Customer complex contracts. The Exchange proposes to
lower this threshold to 0-39,999 Priority Customer complex contracts
and the base rebate of $0.66 per contract, per leg, will now apply to
this tier. With the adoption of a new base tier, what was previously
the base tier is now the second tier. The ADV threshold for this tier
was previously 0-74,999 Priority Customer complex contracts. The
Exchange proposes to amend this threshold so that it is now 40,000-
74,999 Priority Customer complex contracts. The rebate amount for this
tier was previously $0.66 per contract, per leg. The Exchange proposes
to increase the rebate for this tier to $0.70 per contract, per leg.
With the adoption of a new base tier, what was previously the second
tier is now the third tier. The ADV threshold for this tier was
previously 75,000-124,999 Priority Customer complex contracts. The
Exchange is not proposing any change to the ADV threshold for this
tier. The rebate amount for this tier was previously $0.70 per
contract, per leg. The Exchange proposes to increase the rebate for
this tier to $0.74 per contract, per leg. With the adoption of a new
base tier, what was previously the third tier is now the fourth tier.
The ADV threshold for this tier was previously 125,000-249,999 Priority
Customer complex contracts. The Exchange proposes to amend this
threshold by lowering the top end of the range so that it is now
125,000-224,999 Priority Customer complex orders. The rebate amount for
this tier was previously $0.74 per contract, per leg. The Exchange
proposes to increase the rebate for this tier to $0.76 per contract,
per leg. Finally, with the adoption of a new base tier, what was
previously the fourth tier is now the fifth tier. The ADV threshold for
this tier was previously 250,000 or more Priority Customer complex
contracts. The Exchange proposes to amend this threshold by lowering it
so that it is now 225,000 or more Priority Customer complex contracts.
The rebate amount for this tier was previously $0.76 per contract, per
leg. The Exchange proposes to increase the rebate for this tier to
$0.77 per contract, per leg. The highest rebate amount achieved by the
Member for the current calendar month applies retroactively to all
Priority Customer complex order contracts that trade with non-Priority
Customer complex orders in the complex order book executed by the
Member during such calendar month.
    Finally, in SPY, the Exchange currently provides a base rebate of
$0.36 per contract, per leg, for Priority Customer complex orders when
these orders trade with non-Priority Customer complex orders in the
complex order book. Additionally, Members can earn a higher rebate
amount by achieving certain ADV thresholds on a month-to-month basis.
The current ADV threshold for the base tier is 0-74,999 Priority
Customer complex contracts. The Exchange proposes to lower this
threshold to 0-39,999 Priority Customer complex contracts and the base
rebate of $0.36 per contract, per leg, will now apply to this tier.
With the adoption of a new base tier, what was previously the base tier
is now the second tier. The ADV threshold for this tier was previously
0-74,999 Priority Customer complex contracts. The Exchange proposes to
amend this threshold so that it is now 40,000-74,999 Priority Customer
complex contracts. The rebate amount for this tier was previously $0.36
per contract, per leg. The Exchange proposes to increase the rebate for
this tier to $0.37 per contract, per leg. With the adoption of a new
base tier, what was previously the second tier is now the third tier.
The ADV threshold for this tier was previously 75,000-124,999 Priority
Customer complex contracts. The Exchange is not proposing any change to
the ADV threshold for this tier. The rebate amount for this tier was
previously $0.37 per contract, per leg. The Exchange proposes to
increase the rebate for this tier to $0.38 per contract, per leg. With
the adoption of a new base tier, what was previously the third tier is
now the fourth tier. The ADV threshold for this tier was previously
125,000-249,999 Priority Customer complex contracts. The Exchange
proposes to amend this threshold by lowering the top end of the range
so that it is now 125,000-224,999 Priority Customer complex orders. The
rebate amount for this tier was previously $0.38 per contract, per leg.
The Exchange proposes to increase the rebate for this tier to $0.39 per
contract, per leg. Finally, with the adoption of a new base tier, what
was previously the fourth tier is now the fifth tier. The ADV threshold
for this tier was previously 250,000 or more Priority Customer complex
contracts. The Exchange proposes to amend this threshold by lowering it
so that it is now 225,000 or more Priority Customer complex contracts.
The rebate amount for this tier was previously $0.39 per contract, per
leg. The Exchange proposes to increase the rebate for this tier to
$0.40 per contract, per leg. The highest rebate amount achieved by the
Member for the current calendar month applies retroactively to all
Priority Customer complex order contracts that trade with non-Priority
Customer complex orders in the complex order book executed by

the Member during such calendar month.
    Further, the Exchange currently provides a base rebate of $0.06 per
contract, per leg, for Priority Customer complex orders in all symbols
traded on the Exchange (excluding SPY) when these orders trade against
quotes or orders in the regular orderbook. In order to enhance the
Exchange's competitive position and to incentivize Members to increase
the amount of Priority Customer complex orders that they send to the
Exchange, the Exchange has volume-based tiers similar to the volume-
based tiers currently in place for complex orders that trade with non-
Priority Customer complex orders in the complex order book. The current
ADV threshold for the base tier is 0-74,999 Priority Customer complex
contracts. The Exchange proposes to lower this threshold to 0-39,999
Priority Customer complex contracts and the base rebate of $0.06 per
contract, per leg, will now apply to this tier. With the adoption of a
new base tier, what was previously the base tier is now the second
tier. The ADV threshold for this tier was previously 0-74,999 Priority
Customer complex contracts. The Exchange proposes to amend this
threshold so that it is now 40,000-74,999 Priority Customer complex
contracts. The rebate amount for this tier was previously $0.06 per
contract, per leg. The Exchange proposes to increase the rebate for
this tier to $0.07 per contract, per leg. With the adoption of a new
base tier, what was previously the second tier is now the third tier.
The ADV threshold for this tier was previously 75,000-124,999 Priority
Customer complex contracts. The Exchange is not proposing any change to
the ADV threshold for this tier. The rebate amount for this tier was
previously $0.07 per contract, per leg. The Exchange proposes to
increase the rebate for this tier to $0.08 per contract, per leg. With
the adoption of a new base tier, what was previously the third tier is
now the fourth tier. The ADV threshold for this tier was previously
125,000-249,999 Priority Customer complex contracts. The Exchange
proposes to amend this threshold by lowering the top end of the range
so that it is now 125,000-224,999 Priority Customer complex orders. The
rebate amount for this tier was previously $0.08 per contract, per leg.
The Exchange proposes to increase the rebate for this tier to $0.09 per
contract, per leg. Finally, with the adoption of a new base tier, what
was previously the fourth tier is now the fifth tier. The ADV threshold
for this tier was previously 250,000 or more Priority Customer complex
contracts. The Exchange proposes to amend this threshold by lowering it
so that it is now 225,000 or more Priority Customer complex contracts.
The rebate amount for this tier was previously $0.09 per contract, per
leg. The Exchange proposes to increase the rebate for this tier to
$0.10 per contract, per leg. The highest rebate amount achieved by the
Member for the current calendar month applies retroactively to all
Priority Customer complex order contracts that trade with non-Priority
Customer complex orders in the complex order book executed by the
Member during such calendar month.
    For SPY, the Exchange currently provides a base rebate of $0.07 per
contract, per leg, for Priority Customer complex orders traded on the
Exchange when these orders trade against quotes or orders in the
regular orderbook. The current ADV threshold for the base tier is 0-
74,999 Priority Customer complex contracts. The Exchange proposes to
lower this threshold to 0-39,999 Priority Customer complex contracts
and the base rebate of $0.07 per contract, per leg, will now apply to
this tier. With the adoption of a new base tier, what was previously
the base tier is now the second tier. The ADV threshold for this tier
was previously 0-74,999 Priority Customer complex contracts. The
Exchange proposes to amend this threshold so that it is now 40,000-
74,999 Priority Customer complex contracts. The rebate amount for this
tier was previously $0.07 per contract, per leg. The Exchange proposes
to increase the rebate for this tier to $0.08 per contract, per leg.
With the adoption of a new base tier, what was previously the second
tier is now the third tier. The ADV threshold for this tier was
previously 75,000-124,999 Priority Customer complex contracts. The
Exchange is not proposing any change to the ADV threshold for this
tier. The rebate amount for this tier was previously $0.08 per
contract, per leg. The Exchange proposes to increase the rebate for
this tier to $0.09 per contract, per leg. With the adoption of a new
base tier, what was previously the third tier is now the fourth tier.
The ADV threshold for this tier was previously 125,000-249,999 Priority
Customer complex contracts. The Exchange proposes to amend this
threshold by lowering the top end of the range so that it is now
125,000-224,999 Priority Customer complex orders. The rebate amount for
this tier was previously $0.09 per contract, per leg. The Exchange
proposes to increase the rebate for this tier to $0.10 per contract,
per leg. Finally, with the adoption of a new base tier, what was
previously the fourth tier is now the fifth tier. The ADV threshold for
this tier was previously 250,000 or more Priority Customer complex
contracts. The Exchange proposes to amend this threshold by lowering it
so that it is now 225,000 or more Priority Customer complex contracts.
The rebate amount for this tier was previously $0.10 per contract, per
leg. The Exchange proposes to increase the rebate for this tier to
$0.11 per contract, per leg. The highest rebate amount achieved by the
Member for the current calendar month applies retroactively to all
Priority Customer complex order contracts that trade with non-Priority
Customer complex orders in the complex order book executed by the
Member during such calendar month.
    Finally, to incentivize members to trade in the Exchange's various
auction mechanisms, the Exchange currently provides a per contract
rebate to those contracts that do not trade with the contra order in
the Exchange's Facilitation Mechanism and Solicited Order Mechanism,
except when they trade against pre-existing orders and quotes, and to
those contracts that do not trade with the contra order in the, Price
Improvement Mechanism. For the Facilitation and Solicited Order
Mechanisms, the rebate is currently $0.15 per contract. For the Price
Improvement Mechanism, the rebate is currently $0.25 per contract.
These rebates will continue to apply.
    The Exchange is not proposing any other changes in this filing.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Schedule of
Fees is consistent with Section 6(b) of the Exchange Act \7\ in
general, and furthers the objectives of Section 6(b)(4) of the Exchange
Act \8\ in particular, in that it is an equitable allocation of
reasonable dues, fees and other charges among Exchange members and
other persons using its facilities. The impact of the proposal upon the
net fees paid by a particular market participant will depend on a
number of variables, most important of which will be its propensity to
interact with and respond to certain types of orders.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that it is reasonable and equitable to
provide rebates for Priority Customer complex orders when these orders
trade with Non-Priority Customer complex orders

in the complex order book because paying a rebate would continue to
attract additional order flow to the Exchange and create liquidity in
the symbols that are subject to the rebate, which the Exchange believes
ultimately will benefit all market participants who trade on ISE. The
Exchange has already established a volume-based incentive program, and
is now merely proposing to adopt an additional tier and increase the
rebate amounts in that program. The Exchange believes that the proposed
rebates are competitive with rebates provided by other exchanges and
are therefore reasonable and equitably allocated to those members that
direct orders to the Exchange rather than to a competing exchange.
    The Exchange also believes that it is reasonable and equitable to
provide rebates for Priority Customer complex orders when these orders
trade against quotes or orders in the regular orderbook. Again, the
Exchange has already established a volume-based incentive program, and
is now merely proposing to adopt an additional tier and increase the
rebate amounts in that program. The Exchange believes paying these
rebates would also attract additional order flow to the Exchange.
    The Exchange believes that the proposed fee change will generally
allow the Exchange and its Members to better compete for order flow and
thus enhance competition. Specifically, the Exchange believes that its
proposal, which, among other things, adopts a lower base level, and
lowers the highest ADV threshold, so Members can qualify for rebates,
is reasonable as it will encourage Members to increase the amount of
Priority Customer complex orders that they send to the Exchange instead
of sending this order flow to a competing exchange. The Exchange
believes that with the proposed amended tiers, which provides for
additional volume thresholds, more Members are now likely to qualify
for higher rebates.
    The complex order pricing employed by the Exchange has proven to be
an effective pricing mechanism and attractive to Exchange participants
and their customers. The Exchange believes that this proposed rule
change will continue to attract additional complex order business in
the symbols that are subject of this proposed rule change.
    The Exchange believes that the proposed rebates are fair, equitable
and not unfairly discriminatory because they are consistent with price
differentiation and fee structures that exists today at other option
exchanges. The Exchange operates in a highly competitive market in
which market participants can readily direct order flow to another
exchange if they deem rebate levels at a particular exchange to be low.
With this proposed rebate change, the Exchange believes it remains an
attractive venue for market participants to trade complex orders.

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

    The proposed rule change does not 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 not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\9\ At any time within 60 days of the filing
of such proposed rule change, the Commission summarily may temporarily
suspend 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. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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 email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2012-72 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-ISE-2012-72. This file
number should be included on the subject line if email 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
10:00 a.m. and 3:00 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-ISE-2012-72 and should be
submitted on or before October 11, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-23178 Filed 9-19-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Page 60435]
[FR Doc No: 2015-25308]

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DEPARTMENT OF TRANSPORTATION

[Docket DOT-OST-2015-0064; Order 2015-9-15]

Application of Altius Aviation, LLC, for Commuter Authority

AGENCY: Department of Transportation.

ACTION: Notice of Order to Show Cause.

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

SUMMARY: The Department of Transportation is directing all interested
persons to show cause why it should not issue an order finding Altius
Aviation, LLC fit, willing, and able, and awarding it a Commuter Air
Carrier Authorization.

DATES: Persons wishing to file objections should do so no later than
October 5, 2015.

ADDRESSES: Objections and answers to objections should be filed in
Docket DOT-OST-2015-0064 and addressed to U.S. Department of
Transportation, Docket Operations, (M-30, Room W12-140), 1200 New
Jersey Avenue SE., West Building Ground Floor, Washington, DC 20590,
and should be served upon the parties listed in Attachment A to the
order.

FOR FURTHER INFORMATION CONTACT: Lauralyn Remo, Air Carrier Fitness
Division (X-56), U.S. Department of Transportation, 1200 New Jersey
Avenue SE., Washington, DC 20590,<PHONE_NUMBER>.

    Dated: September 21, 2015.
Susan L. Kurland,
Assistant Secretary for Aviation and International Affairs.
[FR Doc. 2015-25308 Filed 10-5-15; 8:45 am]
 BILLING CODE 4910-9X-P