1 THIS VERSION INCLUDES REVISIONS IN THE MUTACGENICITY AND DATAGAP SECTIONS TXR No: 0050672 DATE: April 16, 2002 MEMORANDUM SUBJECT: TEBUTHIURON  THIRD Report of the Hazard identification Assessment Review Committee FROM: Robert F. Fricke, Ph. D. Reregistration Branch 2 Health Effects Division (7509C)

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

TO: Wilhelmena Livingston, Chemical Review Manager Special Review and Registration Division (7508C)

PC CODE: 105501 On December 13, 2001, January 17, 2002 and February 12, 2002, the Hazard Identification assessment Review Committee (HIARC) reviewed the toxicology data base of tebuthiuron and selected endpoints/ doses the acute and chronic reference doses. The HIARC also evaluated the potential for increased susceptibility of infants and children from exposure to tebuthiuron as required by the Food Quality Protection Act (FQPA) of 1996. The conclusions drawn at these meetings are presented in this report. 2 Committee Members in Attendance Members in attendance: Ayaad Assaad, William Burnam, Jonathan Chen, Paula Deschamp Elizabeth Doyle (Co Chair) Pamela Hurley, John Liccione, Elizabeth Mendez, David Nixon Members in absentia:. Jess Rowland (Co Chair)

Also in attendance: Susan Makris, and Pauline Wagner Data evaluation / presentation: Robert F. Fricke Reregistration Branch 2 3 N N S N CH 3 CH 3 C H 3 C H 3 O N H CH 3 Tebuthiuron (105501) 1 INTRODUCTION On December 13, 2001 and January 17, 2002 the Health Effects Division's (HED) Hazard Identification Assessment Review Committee (HIARC) reviewed the recommendations of the toxicology reviewer for tebuthiuron with regard to the acute and chronic Reference Doses (RfD). The potential for increased susceptibility of infants and children from exposure to tebuthiuron was also evaluated. The HIARC met again on February 12, 2002 to discuss the need for an additional uncertainty factor due to the lack of an acceptable chronic toxicity/ carcinogenicity study in rats. The conclusions drawn at these meeting are presented in this report.

2 HAZARD IDENTIFICATION 2.1 Acute Reference Dose (RfD)  Females 13+

Study Selected: Rabbit Developmental Toxicity Guideline No.: 870.3700 (83 4b) Main and Range Finding studies MRID No.: 00020644, 40776301 Executive Summary: In a developmental toxicity study, 15 presumed pregnant Dutch belted rabbits per group were administered tebuthiuron (96.5% a. i.; Lot No.: B30 23 149) by gavage at doses of 0, 10, or 25 mg/ kg/ day on gestation days (GD) 6 18, inclusive. Doses were selected on the basis of preliminary studies summarized in MRID 40776301. Details of the purity and composition of the test article and of the insemination procedure were given in MRID 41122401. On GD 28, all surviving does were sacrificed and examined grossly. Litters were weighed and each fetus examined for viability, sex, and external malformations/ variations. The fetuses were killed, examined viscerally by fresh dissection (including the brain), and the carcasses processed for skeletal examination.

Doses were selected on the basis of preliminary studies which were summarized in MRID 40776301. Mated rabbits (4/ group) were administered 5, 10, 20, 25, 50, or 100 mg/ kg/ day on GD 6 18. Three animals in the 100 mg/ kg/ day group died or were killed moribund on GD 8 10. Overall body weight changes for the treated groups were 140, 5, 37, 72, 103, and

480 g, respectively. 4 In the main study, premature deaths of several animals were considered incidental to treatment. No clinical signs of toxicity were observed in any animal. No effects on body weights, body weight changes, or food consumption were noted for the treated groups as compared with the controls. No treatment related lesions were found at gross necropsy. No differences between the treated and control groups were noted for pregnancy rate or numbers of corpora lutea, implantations, fetuses/ litter, or resorptions. Although the mean fetal body weights of the high dose group were 83% of the control level, the decrease was due to a statistically significant (p # 0.01) negative correlation [increased litter size results in a significant decrease in fetal body weight] between litter size and fetal body weight.

The total number of fetuses( litters) examined in the control, low, and high dose groups was 48( 11), 58( 11), and 68( 12), respectively. No treatment related external, visceral, or skeletal malformations/ variations were observed in this study.

From the range finding study, the percentage of early resorptions in the 25, 50, and 100 mg/ kg/ day groups was 68.8, 66.7, and 100%.

Dose and Endpoint for Establishing RfD: 25 mg/ kg/ day, based on increased number of early resorptions.

Uncertainty Factor( s): 100x (10x intraspecies variability, 10x interspecies extrapolation).

Comments about Study/ Endpoint/ Uncertainty Factor( s): The HIARC considered the data of the main study and the range finding study to establish this endpoint. In the main study, no maternal or developmental toxicity was seen at the highest dose; the NOAEL was 25 mg/ kg/ day (HDT). In the range finding study, early resorptions were observed at 25 (69%), 50 (67%), and 100 (100%) mg/ kg/ day. Although the range finding study indicates that 25 mg/ kg/ day is an effect level, this dose (25 mg/ kg/ day) was selected for risk assessment, since there was no dose response in the observed early resorptions and because there was greater confidence in the results of the main study where no toxicity was seen at this dose (25 mg/ kg/ day) and thus was deemed to be an appropriate dose for risk assessment.

In addition, the selection of the 25 mg/ kg/ day dose for risk assessment is supported by the NOAEL of 50 mg/ kg/ day in a rabbit developmental range finding study with a structurally related urea (UC 77179). This chemical had a toxicity profile similar to that of tebuthiuron. At 200 mg/ kg/ day decreased body weight gain, lethality and early resorption were observed. 5 2.2 Acute Reference Dose (RfD)  General Population An appropriate end point attributable to a single dose was not available in the database. The slight decrease (7%) in body weight gain seen on gestation day 16 in the rabbit study is not attributable to a single dose and no maternal toxicity was seen in the rabbit study.

2.3 Chronic Reference Dose (RfD)

Proposed Study: Two Gen Repro  Rat Guideline No.: OPPTS 870.3800 (83.4)

MRID No.: 00090108 Executive Summary: In a two generation reproduction study, tebuthiuron (Lot No. 00880 1L 1, X 35920, 98.0% a. i.) was fed to groups of 25 male and 25 female Wistar rats per dose at dietary concentrations of 0, 100, 200, and 400 ppm. The dietary levels corresponded to doses of 6 7, 13 14, and 26 28 mg/ kg/ day, respectively, for F0 and F1 males and 7 8, 14 15, and 30 31 mg/ kg/ day, respectively, for F0 and F1 females averaged over the premating period only. Adult rats of both generations were fed the treated or control diets during the premating period (98 days for F0 and 124 days for F1 rats) and during mating, gestation, and lactation of two litters per generation. Pups from the F1a litters were selected to parent the F2 generation.

No treatment related deaths, clinical signs of toxicity, gross lesions, or microscopic lesions were observed in adult rats of either generation. No treatment related effects were observed on body weight, body weight gain, food consumption, or food efficiency in F0 male rats, F1 male rats, or F0 female rats fed any dose at any time during the study including the premating, mating, gestation, and lactation periods. F1 females in the 200 and 400 ppm groups had mean weekly body weights 7 9% (p # .05, not biologically significant) and 8 13% (p # 0.05), respectively, less than the control group throughout the premating period starting with day 14 (10%, NS) for the 200 ppm group and day 7 (12%, p # 0.05) for the 400 ppm group. Weight gain over the entire premating period was 7% (not significant) less than controls for 200 ppm group F1 females and 14% (p # 0.05) less for the 400 ppm group. Cumulative food consumption was not significantly affected, but food efficiency was reduced by 13% (p # 0.01) for 400 ppm group F1 females. The decreased body weights and weight gain did not extend into the gestation or lactation period for F2a litters.

The parental systemic LOAEL for tebuthiuron is 400 ppm (30 mg/ kg/ day) based on deceases in body weight, body weight gain and food consumption of F1 females; the NOAEL is 200 ppm (14 mg/ kg/ day). Parental effect levels were not established for adult male rats in this study.

No effects were observed on reproductive parameters as measured by sperm morphology, fertility index for females, and the number of litters produced. 6 Chronic R D 14 mg / kg /day( NOAEL) 100 (UF) 0.14 mg / kg / day f = = The reproductive LOAEL for tebuthiuron could not be established for this study. The NOAEL is $ 400 ppm (30 mg/ kg/ day).

The F1a, F1b, F2a, or F2b offspring/ litters were not affected by treatment with tebuthiuron in the diet. The mean litter size at birth, litter size throughout lactation, survival indices (live birth, viability, and lactation), and pup weights and pup weight gain throughout lactation were not statistically different between treated and control groups. Pups in the 400 ppm group weighed about 5 14% less than the controls and gained slightly less weight than controls throughout lactation. Mean litter sizes in the 400 ppm group were larger than those for the control group and probably contributed to the lower body weights. Dosing was considered to be barely adequate for assessing reproductive and offspring toxicity.

The offspring LOAEL could not be established for this study. The NOAEL is $ 400 ppm (30 mg/ kg/ day).

This study is classified Acceptable/ Guideline and satisfies the guideline requirement for a two generation reproductive study (OPPTS 870.3800, §83 4) in the rat.

Dose and Endpoint for Establishing RfD: Parental systemic NOAEL of 14 mg/ kg/ day based on decreased body weight, body weight gain and food consumption in F1 females at 30 mg/ kg/ day.

Uncertainty Factor( s): 100x (10x intraspecies variability, 10x interspecies extrapolation.

Co mments about Study/ Endpoint/ Uncertainty Factor( s): The HIARC noted that the chronic toxicity/ carcinogenicity study in rats is unacceptable since at the doses tested (0, 20, 40 or 80 mg/ kg/ day) no treatment related effects were seen for mortality, clinical signs or clinical pathology. Treatment had no effects on absolute body weight or body weight gains in males and there were minimal (15% reduction) changes in absolute body weights in females at termination. There were no effects on neoplastic and non neoplastic lesions in either sex. Because of the lack of systemic toxicity, the HIARC determined that the doses tested were inadequate to assess the chronic toxicity or the carcinogenic potential of tebuthiuron.

The NOAEL of 14 mg/ kg/ day from the two generation reproduction study used for derivation of the chronic RfD is the lowest NOAEL in the database. In the 1 year chronic study in dog, the NOAEL was 25 mg/ kg/ day and the LOAEL was 50 mg/ kg/ day. In the 78 week carcinogenicity study in mice, the NOAEL was 240 mg/ kg/ day (HDT). The HIARC inferred that although a repeat study in rats at higher dose would provide hazard 7 characterization and evaluate the carcinogenic potential of this pesticide, but would not yield a dose that is lower than the dose that is used for derivation of the RfD. The chronic RfD is adequate to protect any adverse toxicity effects following exposure to tebuthiuron. The Committee therefore concluded that an additional uncertainty factor (for data gap) is not needed. The HIARC, however, determined that a repeat study is required to assess the carcinogenic potential of tebuthiuron and recommended that the request for this study should come as a Data Call In notice.

2.4 Occupational/ Residential Exposure Toxicological endpoints for occupational/ residential exposure risk assessments were not selected since tebuthiuron is scheduled for a Tolerance Reassessment Eligibility Decision (TRED)

3 CLASSIFICATION OF CARCINOGENIC POTENTIAL 3.1 Combined Chronic Toxicity/ Carcinogenicity Study in Rats MRID No.: 0020714 Executive Summary: In a chronic toxicity/ carcinogenicity study, tebuthiuron (> 97% a. i., lot number, 6SG43 and B30 23 149) was administered to male and female Wistar rats (40/ group/ sex) at dietary concentrations of 400, 800, or 1600 ppm (20, 40, and 80 mg/ kg/ day, based on the default food factor of 0.05). Two control groups of 60 male and 60 female Wistar rats administered untreated basal diet. No interim sacrifice was conducted for this study. Two replicate studies were carried out.

No treatment related effects were reported for clinical signs, mortality, or clinical pathology in male or female rats receiving any dose of the test material. The mortality rates for all groups was high. During the first year of treatment, 10 19% of males died while at the end on the study, only 26% of all rats remained alive. Pneumonia affected the majority of animals in all groups at various times during the study; antibiotic treatment was required during one episode. Absolute body weights presented graphically indicated that high dose males and females weighed less than controls throughout most of the study. The magnitude of the reduction in absolute body weight could not be determined for assessment of statistical or toxicologic significance. A 15% reductions in body weight in high dose females was observed at study termination. Food consumption was measured but not reported.

Relative kidney weights were depressed in high dose male rats, but no histopathological correlates were observed. Each animal was necropsied, but gross findings were not tabulated. Vacuolization of pancreatic acinar cells (generally slight or affecting only a few cells) was observed in 11 males and 13 females receiving the high dose and in none of the controls of either sex. Only selected histopathological data were presented in the summary tables of the study report; therefore, a complete assessment of histopathological findings could not be conducted. No treatment related neoplasms were reported; common neoplasms included 8 pituitary adenomas and mammary fibroadenomas in female rats. The microscopic findings in the pancreatic acinar cells were generally slight, affected only a few cells, and caused no physiological effect on glucose levels.

Based on the results of this study (decreased terminal body weight in females), the LOAEL for systemic toxicity was established at 80 mg/ kg/ day. The NOAEL was established at 40 mg/ kg/ day in females. A LOAEL was not established in males; the NOAEL was established at 80 mg/ k/ day.

This chronic toxicity/ carcinogenicity study in the rat is Unacceptable/ Guideline and does not satisfy the guideline requirement for a chronic toxicity/ carcinogenicity oral study [OPPTS 870.4300 (§ 83 5)] in the rat.

Adequacy of Dose Levels: The HIARC disagreed with the 1993 RfD conclusions that the doses tested approached an adequate dose because of the minimal change in female body weight. No decrease in body weight was observed in males, further, there was no systemic toxicity. The dose levels were selected from a 90 day feeding study, where decreased body weight, organ weight changes and slight to moderate vacuolization of the pancreatic cells was seen at 2500 ppm. Based on the results of this study, animals could have been tested at higher doses.

Discussion of Tumor Data: No treatment related neoplasms were reported at the doses tested.

3.2 Carcinogenicity Study in Mice MRID No. 00020717 Executive Summary: In a carcinogenicity study, tebuthiuron (> 97% a. i., lot # B30 23 149) was administered to groups of 80 Harlan ICR mice/ sex/ dose in pelleted diet at dose levels of 400, 800, or 1600 ppm (equivalent to 60, 120, or 240 mg/ kg bw/ day based on the default food factor of 0.15) for 2 years. The control group, consisting of 120 males and 120 females was fed untreated pelleted diet. Animals were equally subdivided by dose and sex into two substudies; the second substudy was started 1 week after the first. It should be noted that animals were not assigned by body weight.

Although there was a statistically significant decrease (32.4 g, 12%) in the terminal body weights of high dose females in one of the substudies (M9153), this is likely due to the higher body weight (36.7 g) of the control females in this substudy. The terminal body weight of the control females in the other substudy was 34.1 g.

There were no compound related effects on mortality, clinical signs, hematology or clinical chemistry, organ weights, or gross or microscopic pathology. 9 The LOAEL for systemic toxicity was not established in this study. The NOAEL was established at 1600 ppm (240 mg/ kg/ day).

At the doses tested, there was no treatment related increase in tumor incidence when compared to that of controls. Dosing was not considered adequate based on the absence of systemic effects.

This carcinogenicity study in the mouse is unacceptable/ guideline and does not satisfy guideline requirements for a carcinogenicity study [OPPTS 870.4200; OECD 451] in mice.

Discussion of Tumor Data: No treatment related neoplasms were reported.

Adequacy of the Dose Levels Tested: The HIARC disagreed with the 1993 RfD conclusions that the tumor profile would not change if the dose was increased. At 1600 ppm there was a 12% decrease in female body weight; males were unaffected by treatment.

The dose levels were not considered adequate due to lack of significant toxicity at the highest dose tested.

3.3 Classification of Carcinogenic Potential The HIARC reevaluated the classification and concluded that the carcinogenic potential of tebuthiuron can not be determined due to inadequate carcinogenicity studies. The RfD Committee classified tebuthiuron as a "Group D" Carcinogen  Not classifiable as to human carcinogenicity (Second RfD/ Peer Review Report of Tebuthiuron, March 1, 1993).

4 MUTAGENICITY 4.1 Salmonella typhimurium/ Escherichia coli reverse gene mutation assay [OPPTS 870.5100 (§ 84 2)]

MRID No: 00141691 Executive Summary: In a reverse gene mutation assay in bacteria , S. typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 were exposed to tebuthiuron (98.0%, lot number X 35920) in dimethylsulfoxide (DMSO) at concentrations of 100, 500, 1000, 2500, or 5000 : g/ plate in the presence and absence of mammalian metabolic activation (S9 mix). Triplicate plates were utilized for each test concentration. The S9 fraction was obtained from Aroclor 1254 induced rat liver.

Tebuthiuron was tested up to the limit dose. No increase in mutant frequency was noted in any strain with or without metabolic activation. The solvent (DMSO) and positive control (2 aminoanthracene, 2 nitrofluorene, 9 aminoacridine, N methyl N'nitro N nitroso guanidine values were appropriate in the respective strains. There was no evidence of induced mutant colonies over background in strains TA98, TA100, TA1535, TA1537 and TA1538 with or without S9 activation. 10 This study is classified as Acceptable/ Guideline. It satisfies the requirement for FIFRA Test Guideline [OPPTS 870.5100 (§ 84 2)] for in vitro mutagenicity (bacterial reverse gene mutation) assay.

4.2 Reverse Gene Mutation Assay in Bacteria [OPPTS 870.5100 (§ 84 2)]

MRID No.: 00141690 Executive Summary: In a reverse gene mutation assay in bacteria, S. typhimurium strains G46, TA1535, TA100, C3076, TA1537, D3052, TA1538, and TA98 and E. coli strains WP2 and WP2 uvrA were exposed to tebuthiuron (98.0%, lot number X 35920) in dimethylsulfoxide (DMSO) over a concentration range of 0.1 to 1000 : g/ mL, in a gradient plate assay, in the presence and absence of mammalian metabolic activation (S9 mix). The S9 fraction was obtained from Aroclor 1254 induced rat liver.

No increase in mutant frequency was noted in any S. typhimurium or E. coli tester strain with or without metabolic activation. The solvent (DMSO) and positive control (2 aminoanthracene, N methyl N'nitro N nitrosoguanidine) values were appropriate in the respective strains. There was no evidence of induced mutant colonies over background in S. typhimurium strains G46, TA1535, TA100, C3076, TA1537, D3052, TA1538, and TA98 and E. coli strains WP2 and WP2 uvrA with or without S9 activation.

This study is classified as Acceptable/ Nonguideline.

4.3 Mutagenicity in vitro Cytogenetic Assay [OPPTS 870.5375]

MRID No.: 41134101 Executive Summary: In a mammalian chromosome aberration assay, Chinese Hamster Ovary (CHO) cell cultures were exposed to tebuthiuron (99.08%, lot number 729AS7) in dimethylsulfoxide at concentrations of 0, 1650, 1800, or 1950 : g/ mL for 4 hours in the absence of exogenous metabolic activation (S9 mix) or to 1350, 1450, or 1550 : g/ mL for 4 hours in the presence of activation (followed by an additional 19 hour incubation in fresh medium). The S9 fraction was obtained from Aroclor 1254 induced male Fischer 344 rat liver. Tebuthiuron was tested up to concentrations limited by cytotoxicity. A preliminary cytotoxicity under nonactivated conditions showed survival of 15% at 2285 : g/ mL, 39% at 1750 : g/ mL, 55% at 1500 : g/ mL, and 115% at 1000 : g/ mL. A significant (p< 0.01) increase in the percent of cells with aberrations was noted in nonactivated cultures at 1950 : g/ mL (15 &19% for treated duplicate cultures vs. 5% for vehicle controls) and activated cultures at 1550 : g/ mL (15 &18% for treated duplicate cultures vs. 5 6% for vehicle controls). The predominant types of aberrations were chromosome and chromatid breaks. No significant increases were observed at lower concentrations; however, rare complex aberrations, such as triradials, quadriradials and complex rearrangements were noted, providing further support for clastogenicity. Cyclophosphamide and mitomycin C positive 11 control values were acceptable. There was evidence of an increase in structural chromosomal aberrations over background in the presence and absence of metabolic activation but only at cytotoxic concentrations.

This study is classified as Acceptable/ Guideline. It satisfies the requirement for FIFRA Test Guideline OPPTS 870.5375 (84 2) for in vitro cytogenetic mutagenicity assay.

4.4 In vitro Bone Marrow Cytogenetic Assay [OPPTS 870.5300 (§ 84 2)]

MRID No.: 00145041 Executive Summary: In a mammalian cell gene mutation assay in vitro, cultures of mouse lymphoma L5178Y TK+/ cells were exposed to tebuthiuron (98.0%, lot No. X 35920) in dimethylsulfoxide at concentrations of 100, 200, 300, 400, 500, 600, 700, or 800 : g/ mL in an initial assay the absence of mammalian metabolic activation (S9 mix), and at concentrations of 10, 100, 200, 300, 400, 500, 750, or 1000 : g/ mL in an initial assay in the presence of S9 mix. Due to cytotoxicity, the nonactivated assay was repeated at concentrations of 10, 100, 200, 400, 500, 600, 700, and 800 : g/ mL, and the activated assay was repeated at concentrations of 1, 10, 100, 200, 400, 500, 600, or 700 : g/ mL. The S9 fraction was obtained from Aroclor 1254 induced rats.

Tebuthiuron technical was tested up to concentrations limited by cytotoxicity. Relative growth ranged from 57% to 13% (at 100 to 800 : g/ mL) in the absence of metabolic activation in the initial assay and from 28% to 6% (at 10 to 750 : g/ mL) in the presence of metabolic activation in the initial assay. In the initial nonactivated assay, mutation indices of 2.0 and 2.4 were detected at 700 and 800 : g/ mL, respectively. In a repeat nonactivated assay, mutation indices of 2.0, 2.0, and 2.7 occurred at 200, 400, and 500 : g/ mL, respectively. Mutations were not induced at any concentration with activation. The ethyl methane sulfonate (without S9) and 3 methylcholanthrene (with S9 mix) positive controls responded appropriately. Tebuthiuron was considered weakly mutagenic in the absence of metabolic activation. No evidence of an increased mutant frequency was observed in the presence of metabolic activation.

This study is classified as Acceptable/ Guideline. It does satisfy the requirement for FIFRA Test Guideline [OPPTS 870.5300 (§ 84 2)] for in vitro mutagenicity (mammalian forward gene mutation) data.

4.5 UDS Assay  Primary Rat Hepatocytes [OPPTS 870.5550 (§ 84 2)]

MRID No.: 40750901 Executive Summary: In an unscheduled DNA synthesis assay primary rat hepatocyte cultures were exposed to tebuthiuron (99.1% a. i.; Lot No. 729AS7) in dimethylsulfoxide at eight concentrations ranging from 300 to 800 : g/ mL for 20 hours.

Tebuthiuron was tested to the limit of cytotoxicity. Cytotoxicity was observed at $ 900 12 : g/ mL). UDS activity was evaluated at concentrations up to 800 : g/ mL and there was no evidence of induction of UDS. The solvent (1% DMSO) and positive control (N methyl N'nitrosoguanidine 1 : g/ mL and 2 acetoaminofluorene 0.05 : g/ mL) values were appropriate. There was no evidence that unscheduled DNA synthesis, as determined by radioactive tracer procedures [nuclear silver grain counts] was induced.

This study is classified as Acceptable/ Guideline. It does satisfy the requirement for FIFRA Test Guideline [OPPTS 870.5550 (§ 84 2)] for other genotoxic mutagenicity data.

4.6 Sister Chromatid Exchange [OPPTS 870.5900 (§ 84 2)]

MRID No.: 40750902 Executive Summary: In an in vivo cytogenetic assay measuring sister chromatid exchange (SCE) frequency in Chinese hamster bone marrow cells female Chinese hamsters (3/ group) were administered single oral doses of tebuthiuron (99.1%, Lot No. 729AS7) in 10% aqueous acacia at 3000, 4000, or 5000 mg/ kg.

Tebuthiuron was tested up to cytotoxic concentrations. Hypoactivity was noted in all treatment groups and bone marrow cytotoxicity (as evidenced by an increase in the percent division metaphases) was observed at 5000 mg/ kg. There was no increase in the number of cells containing SCEs compared to controls at any concentration of tebuthiuron tested. Cyclophosphamide (50 mg/ kg) and vehicle control values were acceptable. There was no evidence of an increase in SCEs over background.

This study is classified as Acceptable/ Guideline and satisfies the requirement for FIFRA Test Guideline [OPPTS 870.5915 (§ 84 2)] for in vivo cytogenetic mutagenicity data.

4.7 Conclusions:

The submitted test battery satisfies the Pre 1991 mutagenicity initial testing battery guidelines. Tebuthiuron was not mutagenic in bacteria, but was weakly positive for gene mutations in cultured mouse lymphoma cells. The effect in mammalian cells was, however, confined to non activated test conditions. There was also some evidence of a clastogenic response at cytotoxic doses both with and without S9 activation. Since an acceptable in vivo bone marrow cytogenetic assay is not available, final conclusions regarding the mutagenic potential of tebuthiuron can not be made at this time. 13 5 FQPA CONSIDERATIONS 5.1 Adequacy of the Data Base The toxicology data base is adequate for an FQPA assessment. The required developmental toxicity study in the rabbit does not meet guideline requirements.

6 FQPA CONSIDERATIONS 6.1 Neurotoxicity Data No acute or subchronic neurotoxicity studies on tebuthiuron are available. Evaluation of subchronic, chronic and reproduction toxicity, did not indicate any treatment related effects on the central or peripheral nervous system of mice, rats, or rabbits. No changes in clinical signs, brain weights, gross necropsy results or histopathological results suggested that any part of the nervous system as a target organ.

6.2 Developmental Toxicity 6.2.1 Prenatal Developmental Study  Rat MRID No: 00020803, 40485801 Executive Summary: In a developmental toxicity study, 25 presumed pregnant Harlan rats per group were administered tebuthiuron (purity not given; Lot No. 1093 316A 259) at dietary concentrations of 0, 600, 1200, or 1800 ppm on gestation days (GD) 6 15, inclusive. Doses to the animals were 0, 37, 72, or 110 mg/ kg/ day (calculated from body weight and feed consumption data), respectively. On GD 20, dams were sacrificed and subjected to gross necropsy; pancreatic tissue was saved from 10 females/ group for histopathological examination. Fetal sex, weight, and viability were determined and each fetus was examined for external abnormalities. Approximately one third of all fetuses were fixed in Bouin's solution for subsequent visceral examination and the remainder were cleared for skeletal examination.

All dams survived to terminal sacrifice. No treatment related clinical signs of toxicity were observed in any group. Body weights, body weight gains, and food consumption by the low and mid dose groups were similar to the controls throughout the study. No treatment related lesions were observed in any dam at necropsy. Pancreatic tissue, as evaluated by both gross and microscopic examination, appeared normal.

For the high dose group, absolute body weights were slightly reduced on GD 16 to 93% of the control level due to reduced body weight gains during the entire treatment interval. Body weight gains by the high dose dams were 21% of the control level during GD 6 10 and 57% of the control level during GD 11 15. During the treatment interval, food 14 consumption by the high dose group was 71% of the control amount for GD 6 10 and 95% of the control amount for GD 11 15. Compensatory weight gain and food consumption was observed in the high dose group during the post treatment interval.

The maternal toxicity LOAEL is 1800 ppm (110 mg/ kg/ day) based on decreased body weight gains and food consumption. The maternal toxicity NOAEL is 1200 ppm (72 mg/ kg/ day).

No differences were observed between the treated and control groups for pregnancy rate, number of corpora lutea/ dam, number of implantation sites/ dam, pre or postimplantation losses, number of fetuses/ litter, fetal body weights, or fetal sex ratios. No dead fetuses were observed.

The total number of fetuses( litters) available for examination for malformations/ variations in the control, low, mid, and high dose groups was 259( 23), 263( 21), 300( 23), and 258( 21), respectively. No treatment related abnormalities were found in any fetus. In the control, low, mid, and high dose groups, the total number of fetuses( litters) with external, visceral, or skeletal malformations/ variations was 3( 2), 4( 4), 11( 7), and 4( 3), respectively. Hydronephrosis was a common finding in fetuses from control and treated groups The developmental toxicity NOAEL is $ 1800 ppm (110 mg/ kg/ day) and the developmental toxicity LOAEL was not identified.

This study is classified as Acceptable/ Guideline and satisfies the requirements for a developmental toxicity study [870.3700 (§ 83 3a)] in rats.

6.2.2 Developmental Toxicity Study in the Rabbit MRID No.: 00020644 Executive Summary: In a developmental toxicity study (MRID 00020644), 15 presumed pregnant Dutch belted rabbits per group were administered tebuthiuron (96.5% a. i.; Lot No.: B30 23 149) by gavage at doses of 0, 10, or 25 mg/ kg/ day on gestation days (GD) 6 18, inclusive. Details of the purity and composition and of the insemination procedure were given in MRID 41122401. On GD 28, all surviving does were sacrificed and examined grossly. Litters were weighed and each fetus examined for viability, sex, and external malformations/ variations. The fetuses were killed, examined viscerally by fresh dissection (including the brain), and the carcasses processed for skeletal examination.

Doses for the main study were selected on the basis of a preliminary range finding study (MRID 40776301). In this study, mated rabbits (4/ group) were administered 5, 10, 20, 25, 50, or 100 mg/ kg/ day on GD 6 18. Three animals in the 100 mg/ kg/ day group died or were killed moribund on GD 8 10. Overall body weight changes for the treated 15 groups were 140, 5, 37, 72, 103, and 480 g, respectively. The percentage of resorptions in the 25, 50, and 100 mg/ kg/ day groups was 68.8, 66.7, and 100%..

In the main study, premature deaths of several animals were considered incidental to treatment. No clinical signs of toxicity were observed in any animal. No effects on body weights, body weight changes, or food consumption were noted for the treated groups as compared with the controls. No treatment related lesions were found at gross necropsy.

The maternal toxicity NOAEL was established at 25 mg/ kg/ day; the LOAEL for maternal toxicity was not established.

No differences between the treated and control groups were noted for pregnancy rate or numbers of corpora lutea, implantations, fetuses/ litter, or resorptions. Although the mean fetal body weights in the high dose group were significantly lower than the control value, the decreases were attributed to increased liter size.

The total number of fetuses( litters) examined in the control, low, and high dose groups was 48( 11), 58( 11), and 68( 12), respectively. No treatment related external, visceral, or skeletal malformations/ variations were observed in this study.

The developmental toxicity NOAEL is established at 25 mg/ kg/ day; the LOAEL was not established.

This study is classified as Unacceptable/ Guideline and does not satisfy the guideline requirements for a developmental toxicity study [870.3700 (§ 83 3b)] in rabbits.

6.3 Reproductive Toxicity 6.3.1 Two Generation Reproduction  Rat MRID No: 90108 Executive Summary: In a two generation reproduction study, tebuthiuron (Lot No. 00880 1L 1, X 35920, 98.0% a. i.) was fed to groups of 25 male and 25 female Wistar rats per dose at dietary concentrations of 0, 100, 200, and 400 ppm. The dietary levels corresponded to doses of 6 7, 13 14, and 26 28 mg/ kg/ day, respectively, for F0 and F1 males and 7 8, 14 15, and 30 31 mg/ kg/ day, respectively, for F0 and F1 females averaged over the premating period only. Adult rats of both generation were fed the treated or control diets during the premating period (98 days for F0 and 124 days for F1 rats) and during mating, gestation, and lactation of two litters per generation. Pups from the F1a litters were selected to parent the F2 generation. 16 No treatment related deaths, clinical signs of toxicity, gross lesions, or microscopic lesions were observed in adult rats of either generation. No treatment related effects were observed on body weight, body weight gain, food consumption, or food efficiency in F0 male rats, F1 male rats, or F0 female rats fed any dose at any time during the study including the premating, mating, gestation, and lactation periods. F1 females in the 2 00 and 400 ppm groups had mean weekly body weights 7 9% and 8 13% (p< 0.01 or <0.05), respectively, less than the control group throughout the premating period starting with day 21 for the 200 ppm group and day 7 for the 400 ppm group. Weight gain over the entire premating period was 7% (N. S.) less than controls for 200 ppm group F1 females and 14% (p< 0.05) less for the 400 ppm group. Cumulative food consumption was not significantly affected, but food efficiency was reduced by 13% (p< 0.01) for 400 ppm group F1 females. The decreased body weights and weight gain did not extend into the gestation or lactation period for F2a litters.

The parental systemic LOAEL for tebuthiuron is 400 ppm (30 mg/ kg/ day) for female rats based on deceases in body weight and weight gain; the corresponding NOAEL is 200 ppm (14 mg/ kg/ day). Parental effect levels were not established for adult male rats in this study.

No effects were observed on reproductive parameters as measured by sperm morphology, fertility index for females, and the number of litters produced.

The reproductive LOAEL for tebuthiuron could not be established for this study. The NOAEL is $ 400 ppm (30 mg/ kg/ day)

The F1a, F1b, F2a, or F2b offspring/ litters were not affected by treatment with tebuthiuron in the diet. The mean litter size at birth, litter size throughout lactation, survival indices (live birth, viability, and lactation), and pup weights and pup weight gain throughout lactation were not statistically different between treated and control groups. Mean litter size in 400 ppm group was larger than those for the control group and probably contributed to the lower body weights. Dosing was considered to be barely adequate for assessing reproductive and offspring toxicity.

The offspring LOAEL could not be established for this study. The NOAEL is $ 400 ppm. (30 mg/ kg/ day).

This study is classified Acceptable/ Guideline and satisfies the guideline requirement for a two generation reproductive study (OPPTS 870.3800, §83 4) in the rat.

6.4 Additional Information from Literature Sources No studies available 17 6.5 Determination of Susceptibility There is no qualitative/ quantitative evidence of increased susceptibility following in utero exposure to rats or following pre/ post natal exposure to rats in the 2 generation reproduction study. Susceptibility could not be assessed due to the lack of maternal or developmental toxicity at the highest dose tested..

6.6 Evidence That Suggest Study Requiring a Developmental Neurotoxicity Study The need for a developmental neurotoxicity study is being held in reserve, pending submission of developmental toxicity studies in the rabbit (data gap).

6.7 Evidence That Do Not Suggest Requiring a Developmental Neurotoxicity Study:

(1) No neurological signs or neuropathy were observed in any of the studies.

(2) No increased susceptibility in rat developmental study.

(3) No increased susceptibility the 2 generation reproduction study in the rat.

7 HAZARD CHARACTERIZATION The toxicological database for tebuthiuron is not considered adequate for hazard characterization. The developmental toxicity studies in the rat and rabbit as well as the chronic feeding study in the rat and oncogenicity studies in the rat and mouse were found to be unacceptable. Further, because tebuthiuron was weakly positive for gene mutations in cultured mouse lymphoma cells, an in vivo mammalian bone marrow chromosomal aberration assay is also required.

The acute toxicity studies indicate that tebuthiuron, technical, is more toxic for oral (Toxicity Category II) exposure than for either dermal (Toxicity Category IV) or inhalation (Toxicity Category III). The primary eye and skin irritation studies were both Toxicity Category IV; no dermal sensitization occurred with tebuthiuron in guinea pigs.

Although the most consistent toxicological effect was decreased body weight, histopathological changes in the pancreas were observed in the rat. Vacuolation of pancreatic acinar cells was observed in both the subchronic and chronic feeding studies. Vacuolation was described as slight or affecting only a few cells.

Subchronic feeding studies are available in the rat and dog, as well as a 21 day dermal toxicity study in the rabbit. In the rat study, reduced body weight, increases in relative liver, kidney and gonad weights, and slight vacuolation of pancreatic acinar cells were observed in both sexes; males also had increased relative spleen and prostate gland weights. In the dog study, anorexia, 18 weight loss, increases in blood urea nitrogen and alkaline phosphatase, and increases in spleen and thyroid gland weights were observed. In the 21 day dermal toxicity study in rabbits, no dermal or systemic toxicity was observed at 1000 mg/ kg/ day (limit dose).

Tebuthiuron toxicity was also evaluated in a combined chronic toxicity/ oncogenicity study in the rat and a chronic feeding study in the dog. Decreased body weights were observed in both the rat and dog. Vacuolization of pancreatic acinar cells (generally slight or affecting only a few cells) was observed in rats, while increased liver and thyroid weights were observed in the dog.

At the doses tested, neither the rat nor mouse showed any treatment related increase in the incidence of neoplasms. However, these dose levels were too low to assess the carcinogenic potential of tebuthiuron.

Rat and rabbit developmental toxicity studies were carried out with tebuthiuron. In the rat, no compound related developmental effects were observed. In the rabbit susceptibility could not be evaluated due to lack of maternal and developmental toxicity at the high dose tested.

In a two generation study in the rat, the only toxicological effect observed was a statistically and biologically significant decrease in the mean body weight of throughout the premating period; no offspring toxicity was seen.

Tebuthiuron was not mutagenic in bacteria, but was weakly positive for gene mutations in cultured mouse lymphoma cells. The effect in mammalian cells was, however, confined to nonactivated test conditions. There was also some evidence of a clastogenic response at cytotoxic doses both with and without S9 activation. Since an acceptable in vivo bone marrow cytogenetic assay is not available, final conclusions regarding the mutagenic potential of tebuthiuron can not be made at this time.

8 DATAGAPS The HIARC identified the following data gaps:

28 day inhalation study in the rat  due to potential long term inhalation exposure based on the current use pattern..

Developmental toxicity study in the rabbit  the current study is unacceptable and is not adequate to assess susceptibility for FQPA.

Chronic feeding/ oncogenicity study in the rat  doses tested were not adequate to assess the carcinogenic potential.

Carcinogenicity study in the mouse  doses tested were not adequate to assess the carcinogenic potential.

In vivo bone marrow chromosomal aberration test  Tier II test, required to verify the positive response in the in vitro chromosomal assay.

Developmental neurotoxicity study  in Reserve pending submission of developmental 19 toxicity in the rabbit.

9 ACUTE TOXICITY Acute Toxicity of Tebuthiuron, Technical Guideline No. Study Type MRID No. Results Toxicity Category 870.1100 Acute Oral (Rat) 40583901 LD50 = 477.5 mg/ kg ( % % ) 387.5 mg/ kg ( & & ) II 870.1200 Acute Dermal (Rabbit) 40583902 LD50 = > 5000 mg/ kg ( % % and & & ) IV 870.1300 Acute Inhalation (Rat) 00155730 LC50 = 3. 696 mg/ L III 870.2400 Primary Eye Irritation 40583903 Slight irritation IV 870.2500 Primary Skin Irritation 40583902 Non irritating IV 870.2600 Dermal Sensitization 40583904 Non sensitizing – 20 10 SUMMARY OF TOXICOLOGY ENDPOINT SELECTION The doses and toxicological endpoints selected for Tebuthiuron EXPOSURE SCENARIO DOSE (mg/ kg/ day) ENDPOINT STUDY Acute Dietary (Females 13 50) NOAEL= 25 UF = 100 Increased post implantation loss and fetal/ litter resorptions at 50 mg/ kg/ day (LOAEL). Developmental Toxicity Study in the Rabbit Acute RfD (Females 13 50 years old) = 0.25 mg/ kg Acute Dietary (General Population) No appropriate effects attributed to a single exposure was identified.

Chronic Dietary NOAEL = 14 UF = 100 Decreased body weight and feed consumption in F1 females at 30 mg/ kg/ day (LOAEL) 2 Generation Reproduction Study in the Rat Chronic RfD = 0. 14 mg/ kg/ day Toxicological endpoints for occupational/ residential exposure risk assessments were not selected since tebuthiuron is scheduled for a Tolerance Reassessment Eligibility Decision (TRED)


                     INDEX TO DOCKET EPA-R09-OAR-2013-0663                NEVADA INFRASTRUCTURE SIP FOR THE 2008 Lead (Pb)                       NATIONAL AMBIENT AIR QUALITY STANDARD                                 (October 2013)                                                                          PROPOSED RULE

CATEGORY I	RULEMAKING DOCUMENTS

   1.       Proposed Rule, "Partial Approval and Disapproval of Air Quality State Implementation Plans; Nevada; Infrastructure Requirements for Lead (Pb)," signed September 30, 2013 (pre-publication version).

   2.       EPA Region 9, "Pb Infrastructure SIP: Technical Support Document," September 2013.

   3.       EPA Region 9, "Technical Support Document: Evaluation of EPA Evaluation of Nevada Provisions for Section 110(a)(2)(E)(ii)/Section 128 Conflict of Interest Requirements," July 2012.

CATEGORY II 	STATE SUBMITTALS

   1. Letter from Colleen Cripps, Administrator, Nevada Division of Environmental Protection (NDEP), "Nevada's Clean Air Act § 110(a)(1) and (2) State Implementation Plan for the 2008 Lead NAAQS" to Jared Blumenfeld, Regional Administrator, U.S. Environmental Protection Agency (EPA) Region 9, October 12, 2011, with enclosures.

   2. Letter from Colleen Cripps, Administrator, NDEP, "Clark County Portion of Nevada's Clean Air Act § 110(a)(1) and (2) State Implementation Plan for the 2008 Lead NAAQS" to Jared Blumenfeld, Regional Administrator, EPA Region 9, July 23, 2012, with enclosures.

   3. Letter from Colleen Cripps, Administrator, NDEP, "Revisions to Nevada's Clean Air Act § 110(a)(2)State Implementation Plan Submittals" to Jared Blumenfeld, Regional Administrator, EPA Region 9, August 30, 2012, with enclosures.

CATEGORY III	INCORPORATION BY REFERENCE DOCUMENTS

[Reserved]

CATEGORY IV	OFFICIAL PUBLIC COMMENT ON THE NPRM

[Reserved]

CATEGORY V	OTHER DOCUMENTS

         1. Memorandum issued by Edward E. Reich, Director of the Division of Stationary Source Enforcement, EPA, "Clarification of Requirements for Inclusion of Continuous Emission Monitoring Provisions in State Implementation Plans," May 9, 1980.

         2. "Agreement for Delegation of the Federal Prevention of Significant Deterioration Program by the United States Environmental Protection Agency, Region 9 to the Nevada Division of Environmental Protection," October 19, 2004.

         3. Memorandum issued by Air Quality Analysis Division (AQAD), Office of Air Quality Planning and Standards (OAQPS), EPA, "Guidance on the Use of Models and Other Analyses for Demonstrating Attainment of Air Quality Goals for Ozone, PM2.5 and Regional Haze," April, 2007.

         4. "Agreement for Delegation of the Federal Prevention of Significant Deterioration Program by the United States Environmental Protection Agency, Region 9 to the Washoe County District Health Department", March 13, 2008.

         5. "Agreement for Delegation of the Federal Prevention of Significant Deterioration Program by the United States Environmental Protection Agency, Region 9 to the Nevada Division of Environmental Protection," September 15, 2011.

         6. Memorandum issued by William T. Harnett, Director, Air Quality Policy Division (AQPD), OAQPS, EPA, "Guidance on SIP Elements Required Under Sections 110(a)(1) and (2) for the 2006 24-Hour Fine Particle (PM2.5) National Ambient Air Quality Standards (NAAQS)," September 25, 2009.

         7. Letter from Leo M. Drozdoff, Administrator, NDEP, "Current CAA 110(a)(2)(A)-(M) Requirements in Washoe County Portion of Nevada's PM2.5 infrastructure State Implementation Plan" to address 2006 24-hour PM2.5 NAAQS to Laura Yoshii, Acting Regional Administrator, EPA Region 9, December 4, 2009, with enclosure.

         8. NDEP Bureau of Air Quality Planning (BAQP), "Ambient Air Monitoring Network Plan," 2012.

         9. Clark County Department of Air Quality (DAQ), "Annual Network Plan Report," June 2012.

         10. Washoe County Health District Air Quality Management Division (AQMD), "2012 Ambient Air Monitoring Network Plan," July 2, 2012.

         11. Clark County Air Quality Regulation Section 2, "Procedures for adoption and revision of regulations and for inclusion of those regulations in the State Implementation Plan," Amended December 20, 2005.

         12. Letter from Allen Biaggi, Director, Nevada Department of Conservation and Natural Resources, to Wayne Nastri, Regional Administrator, EPA Region 9, regarding authority of the Administrator or Deputy Administrator of NDEP, May 30, 2007.

         13. Clark County Air Quality Regulation Section 12.5, "Part 70 Operating Permit Requirements," Adopted May 18, 2010.

         14. Draft memorandum prepared by AQPD, OAQPS, EPA, "DRAFT Guidance on SIP Elements Required Under Sections 110(a)(1) and (2) for the 2008 Lead (Pb) National Ambient Air Quality Standards (NAAQS)," June 17, 2011 version.

         15. Memorandum issued by Stephen D. Page, Director, OAQPS, EPA to Regional Air Division Directors, EPA Regions 1-10, "Guidance on Infrastructure State Implementation Plan Elements Required Under Sections 110(a)(1) and 110(a)(2) for the 2008 Lead (Pb) National Ambient Air Quality Standards (NAAQS)," October 14, 2011.

         16. Memorandum issued by Mark Schmidt, AQAD, OAQPS, EPA, "The Estimated Contribution of Ambient Lead (Pb) to Class I Visibility Impairment," November 7, 2011.

         17. EPA Region 9, "Technical Support Document for EPA's Notice of Proposed Rulemaking for revisions to the Nevada State Implementation Plan, Clark County Department of Air Quality and Environmental Management, New Source Review Permitting Program, Including Minor NSR, NSR and PSD programs," July 11, 2012.

         18. EME Homer City Generation v. EPA, No. 11-1302, U.S. Court of Appeals for the District of Columbia Circuit (D.C. Cir., August 21, 2012).

         19. Sierra Club v. EPA, No. 10-1413,(D.C. Cir., January 22, 2013).

         20. "Agreement for Delegation of the Federal Prevention of Significant Deterioration (PSD) Program by the United States Environmental Protection Agency, Region 9 to the Nevada Division of Environmental Protection," November 7, 2012.

         21. NDEP BAQP, "Ambient Air Monitoring Network Plan," 2013.

         22. Clark County DAQ, "Annual Network Plan Report," June 2013.

         23. Washoe County Health District AQMD, "2013 Ambient Air Monitoring Network Plan" July 1, 2013.

         24. Clark County Air Quality Regulation Section 18, "Permit and Technical Service Fees," Amended February 11, 2013.

         25. Letter from Matthew Lakin, Air Quality Analysis Office (AQAO), EPA Region 9 to Rob Bamford, Chief, BAQP, NDEP, February 28, 2013, with enclosure.

         26. Letter from Matthew Lakin, AQAO, EPA Region 9 to Mike Sword, Engineering Manager, Clark County DAQ, February 28, 2013, with enclosure.

         27. Letter from Matthew Lakin, AQAO, EPA Region 9 to Daniel Inouye, Branch Chief, Monitoring and Planning, AQMD, Washoe County Health District, February 28, 2013, with enclosure.

         28. EME Homer City Generation, L.P. v. EPA, 696 F .3d 7 (D.C. Cir., 2012), cert. granted, 2013 U.S. Lexis 4801 (June 24, 2013).

         29. Lead (Pb) source data from 2008 National Emissions Inventory Database, August 2013.

         30. NDEP, "Nevada Air Quality Trend Report 2000-2010," downloaded from NDEP's website, http://ndep.nv.gov/baqp/index.htm, on September 4, 2013.

         31. Washoe County Air Quality Regulation 030.000, "Source Permitting and Operation," downloaded from Washoe County Health District Air Quality Management District's website, http://www.washoecounty.us/health/air/regulations.html, on September 13, 2013.

         32. Memorandum issued by Stephen D. Page, Director, OAQPS, EPA to Regional Air Division Directors, EPA Regions 1-10, "Guidance on Infrastructure State Implementation Plan Elements Under Clean Air Act Sections 110(a)(1) and 110(a)(2)," September 13, 2013.

         33. EPA, Jefferson Wehling, Memo to file regarding Washoe County Health District AQMD's interpretation of rule references to National Ambient Air Standards, September 13, 2013.

CATEGORY VI	FEDERAL REGISTER NOTICES

   1. 37 FR 10842, "Part 52 - Approval and Promulgation of Implementation Plans," May 31, 1972.

   2. 37 FR 15086, "Part 52  -  Approval and Promulgation of Implementation Plans," July 27, 1972.

   3. 38 FR 12702, "Part 52 - Approval and Promulgation of Implementation Plans," May 14, 1973.

   4. 40 FR 13306, "Part 52 - Approval and Promulgation of Implementation Plans, Nevada Indirect Source Regulations," March 26, 1975.

   5. 43 FR 1341, "Part 52  -  Approval and Promulgation of Implementation Plans, Air Pollution Control, State Regulations, State of Nevada," January 9, 1978.

   6. 45 FR 46384, "Nevada State Implementation Plan Revision: Nevada Revised Statutes and the Emergency Episode Plan," July 10, 1980.

   7. 46 FR 21758, "Approval and Promulgation of Implementation Plans; Nonattainment Area Plans for the State of Nevada," April 14, 1981.

   8. 46 FR 43141, "Nevada State Implementation Plan Revision," August 27, 1981.

   9. 47 FR 26386, "Approval and Promulgation of Implementation Plans; Nevada State Implementation Plan Revision," June 18, 1982.

   10. 47 FR 26620, "Nevada; Approval and Promulgation of Implementation Plans," June 21, 1982.

   11. 48 FR 28271, "Prevention of Significant Deterioration; Delegation of Authority, State of Nevada," June 21, 1983.

   12. 49 FR 26736, "Approval and Promulgation of Implementation Plans; State of Nevada," June 29, 2984.

   13. 58 FR 51735, "Executive Order 12866," October 4, 1993.

   14. 59 FR 7629, "Executive Order 12898," February 16, 1994.

   15. 62 FR 19885, "Executive Order 13045," April 23, 1997.

   16. 64 FR 43255, "Executive Order 13132," August 10, 1999.

   17. 65 FR 67249, "Executive Order 13175," November 9, 2000.

   18. 66 FR 28355, "Executive Order 13211," May 22, 2001.

   19. 66 FR 63188, "Clean Air Act Full Approval of Title V Operating Permits Programs; Clark County Department of Air Quality Management, Washoe County District Health Department, and Nevada Division of Environmental Protection, Nevada," December 5, 2001.

   20. 67 FR 80186, "Prevention of Significant Deterioration and Nonattainment New Source Review: Baseline Emissions Determination, Actual-to-Future-Actual Methodology, Plantwide Applicability Limitations, Clean Units, Pollution Control Projects," December 31, 2002.

   21. 68 FR 11323, "Approval and Promulgation of Implementation Plans; Prevention of Significant Deterioration," March 10, 2003.

   22. 68 FR 74489, "Approval and Promulgation of Implementation Plans; Prevention of Significant Deterioration," December 24, 2003.

   23. 69 FR 54006, "Approval and Promulgation of Implementation Plans; New Source Review; State of Nevada, Clark County Department of Air Quality and Environmental Management," September 7, 2004.

   24. 70 FR 68218, "Revisions to the Guideline of Air Quality Models: Adoption of a Preferred General Purpose (Flat and Complex Terrain) Dispersion Model and Other Revisions," November 9, 2005.

   25. 70 FR 71612, "Final Rule to Implement The 8-Hour Ozone National Ambient Air Quality Standard-Phase 2; Final Rule to Implement Certain Aspects of the 1990 Amendments Relating to New Source Review and Prevention of Significant Deterioration as They Apply in Carbon Monoxide, Particulate Matter, and Ozone NAAQS; Final Rule for Reformulated Gasoline," November 29, 2005.

   26. 71 FR 51766, "Revisions to the Nevada State Implementation Plan," August 31, 2006.

   27. 71 FR 75690, "Approval and Promulgation of Implementation Plans; Revisions to the Nevada State Implementation Plan; Excess Emissions Provisions," December 18, 2006.

   28. 72 FR 11, "Approval and Promulgation of Implementation Plans; Revisions to the Nevada State Implementation Plan; Requests for Rescission," January 3, 2007.

   29. 72 FR 19801, "Approval and Promulgation of Implementation Plans; Revisions to the Nevada State Implementation Plan; Definition, Emergency Episode, and Monitoring Regulations," April 20, 2007.

   30. 72 FR 32526, "Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): Removal of Vacated Elements," June 13, 2007.

   31. 72 FR 33397, "Revisions to the Nevada State Implementation Plan, Washoe County District Health Department," June 18, 2007.

   32. 73 FR 20536, "Approval and Promulgation of Implementation Plans; Revisions to the Nevada State Implementation Plan; Stationary Source Permits," April 16, 2008.

   33. 73 FR 28321, "Implementation of the New Source Review (NSR) Program for Particulate Matter Less Than 2.5 Micrometers (PM2.5)," May 16, 2008.

   34. 73 FR 66964, "National Ambient Air Quality Standards for Lead," November 12, 2008.

   35. 75 FR 31514, "Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule," June 3, 2010.

   36. 75 FR 45485, "Determination of Attainment for PM10 for the Las Vegas Valley Area, NV," August 3, 2010.

   37. 75 FR 59090, "Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; State of Nevada; Redesignation of Las Vegas Valley to Attainment for the Carbon Monoxide Standard," September 27, 2010

   38. 75 FR 64864, "Prevention of Significant Deterioration (PSD) for Particulate Matter Less Than 2.5 Micrometers (PM2.5) -- Increments, Significant Impact Levels (SILs) and Significant Monitoring Concentration (SMC)," October 20, 2010.

   39. 75 FR 82536, "Limitation of Approval of Prevention of Significant Deterioration Provisions Concerning Greenhouse Gas Emitting Sources in State Implementation Plans; Final Rule," December 30, 2010.

   40. 76 FR 21807, "Approval and Promulgation of Implementation Plans; State of Nevada; PM - 10; Determinations Regarding Attainment for the Truckee Meadows Nonattainment Area and Applicability of Certain Clean Air Act Requirements," April 19, 2011.

   41. 76 FR 36450, "Approval and Promulgation of Air Quality Implementation Plans; State of Nevada; Regional Haze State Implementation Plan," June 22, 2011.

   42. 76 FR 72097, "Air Quality Designations for the 2008 Lead (Pb) National Ambient Air Quality Standards," November 22, 2011.

   43. 77 FR 17334 at 17339, "Approval and Promulgation of Air Quality Implementation Plans; State of Nevada; Regional Haze State Implementation Plan," March 26, 2012.

   44. 77 FR 38557, "Approval and Promulgation of Implementation Plans; Revisions to the Nevada State Implementation Plan; Stationary Source Permits," June 28, 2012.

   45. 77 FR 43206, "Limited Approval and Disapproval of Air Quality Implementation Plans; Nevada; Clark County; Stationary Source Permits," July 24, 2012.

   46. 77 FR 46361, "Partial Approval and Disapproval of Air Quality Implementation Plans; Nevada; Infrastructure Requirements for Ozone and Fine Particulate Matter," August 3, 2012.

   47. 77 FR 50936, "Approval and Promulgation of Air Quality Implementation Plans; Nevada; Regional Haze State and Federal Implementation Plans; BART Determination for Reid Gardner Generating Station," August 23, 2012.

   48. 77 FR 59321, "Approval and Promulgation of Implementation Plans; Revisions to the Nevada State Implementation Plan; Stationary Source Permits," September 27, 2012.

   49. 77 FR 60915, "Revisions to the Nevada State Implementation Plan, Washoe County Air Quality District," October 5, 2012.

   50. 77 FR 64039, "Limited Approval and Disapproval of Air Quality Implementation Plans; Nevada; Clark County; Stationary Source Permits," October 18, 2012.

   51. 77 FR 64737, "Partial Approval and Partial Disapproval of Air Quality State Implementation Plans; Nevada; Infrastructure Requirements for Ozone and Fine Particulate Matter," October 23, 2012.

   52. 78 FR 1149, "Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; State of Nevada; Redesignation of Clark County to Attainment for the 1997 8-Hour Ozone Standard," January 8, 2013.


From:
Brenna M Harden<EMAIL_ADDRESS>Sent:
Friday, February 10, 2023 3:45 PM
To:
Jones, DonnaLee<EMAIL_ADDRESS>'French, Chuck'<EMAIL_ADDRESS>Coke ICR2<EMAIL_ADDRESS>Cc:
Rob Sanch<EMAIL_ADDRESS>Fadi K Mourad<EMAIL_ADDRESS>Marion M Krchmar<EMAIL_ADDRESS>Laura J Harris<EMAIL_ADDRESS>Robert H Carlin<EMAIL_ADDRESS>Subject:
Coke Oven Section 114 ICR Enclosure 2 - EES Final Report Fugitive Monitoring (First 3-months) - Email 1 of 2

On June 29, 2022, DTE Vantage (DTE) received a Section 114 of the Clean Air Act Information Collection Request (ICR) in relation to development of Risk and Technology Review of Coke Oven Facilities related to 40 CFR Part 63, Subpart CCCCC, Pushing Quenching and Battery Stacks. The ICR also included risk and technology review, testing, interior and fenceline monitoring, and other information collection activities related to potential new regulations for coke byproduct recovery plants (CBRP) in relation to 40 CFR Part 63, Subpart L, Coke Oven Batteries. DTE owns and operates EES Coke Battery, L.L.C. (EES Coke) located in River Rouge, MI.

EES Coke was selected for Flares and Fugitives under the Enclosure 2 scope and Fugitives fall under the stack testing portion of the scope. The enclosed Source Test Report and the excel file (EPA Enclosure 2 in the second of two email) provides updated results of the fugitive monitoring of the fenceline and interior locations for the coke byproduct recovery plant. As not all laboratory data was received by the January 24 deadline, EPA had allowed a preliminary report per email approval on January 17, 2023.

Please contact me at<EMAIL_ADDRESS>or<PHONE_NUMBER> should you have any further questions

Regards,
Brenna Harden
DTE Vantage | EES Coke Battery, L.L.C., Senior Environmental Engineer
PO Box 18309, River Rouge, MI 48218
o<PHONE_NUMBER> | m<PHONE_NUMBER>
dtevantage.com

<< EESCoke_River Rouge_ICR Fenceline Fugitive ICR Report_FINAL 3-Month_R1a.pdf >>


[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31979-31981]
[FR Doc No: 2016-11879]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77839; File No. SR-NASDAQ-2016-066]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Nasdaq Rule 4703

May 16, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 4, 2016, The Nasdaq Stock Market LLC (``Nasdaq'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by Nasdaq. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 4703 (Order Attributes).
    The text of the proposed rule change is available at http://nasdaq.cchwallstreet.com/, at Nasdaq's principal office, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. Nasdaq 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
    Nasdaq is proposing to amend Rule 4703(a)(7). This rule currently
provides that a market participant entering an order using the SCAN
routing strategy prior to 8:00 a.m. Eastern time (``ET'') may designate
the order to activate upon entry or at 8:00 a.m. ET. The Exchange
proposes to extend this functionality to the recently approved Retail
Order Process (``RTFY'') order routing option.\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 76335 (Nov. 3,
2015), 80 FR 69256 (Nov. 9, 2015) (SR-NASDAQ-2015-112).
---------------------------------------------------------------------------

    The RTFY order routing option is designed to enhance execution
quality and benefit retail investors by providing price improvement
opportunities to retail order flow. Previously, retail order firms
often sent non-marketable order flow, that is--orders that are not
executable against the best prices available in the market place based
on their limit price--to post and display on exchanges. Some of the
orders that have been deemed to be non-marketable by the entering firm
become marketable by the time the exchange receives them and ultimately
remove liquidity from the exchange order book. The RTFY routing option
is an alternative method for posting non-marketable order flow on the
Exchange order book. Rather than allowing the marketable Designated
Retail Orders (``DROs'') \4\ to immediately remove liquidity from the
Exchange order book (unless explicitly instructed to do so), the order
is routed to destinations in the System routing table \5\ to increase
price improvement opportunities for the DROs. RTFY may remove liquidity
from the Exchange book after routing to other destinations. Any non-
marketable RTFY orders will post on the Exchange book.
---------------------------------------------------------------------------

    \4\ See Nasdaq Rule 7018.
    \5\ The term ``System routing table'' refers to the proprietary
process for determining the specific trading venues to which the
System routes orders and the order in which it routes them. NASDAQ
reserves the right to maintain a different System routing table for
different routing options and to modify the System routing table at
any time without notice. See NASDAQ Rule 4758(a)(1)(A).
---------------------------------------------------------------------------

    Under the SCAN \6\ routing strategy orders can check the System for
available shares and simultaneously route the remaining shares to
destinations on the System routing table. Shares that remain unexecuted
after routing are posted on the Exchange book. Once on the Exchange
book, if the order is subsequently locked or crossed by another market
center, the System will not route the order to the locking or crossing
market center.
---------------------------------------------------------------------------

    \6\ See Nasdaq Rule 4758(a)(1)(A)(iv).
---------------------------------------------------------------------------

    Currently, RFTY users may enter extended hours orders, which may
execute, route, or post to the book prior to the beginning of regular
hours trading. Extended hours orders are accepted starting at 4 a.m.
ET. SCAN users may also send extended hours orders which are eligible
for execution, routing, and posting prior to regular market hours
trading. However, SCAN users may also designate that their extended
hours orders not activate until 8 a.m. Some market participants
maintain systems that do not allow executions prior to 8 a.m. The
Exchange believes this functionality for SCAN orders supports market
participants by giving them the ability to allow orders to flow through
to the Exchange while keeping them inactive until 8 a.m.
    The Exchange believes that the market participants who currently
use this functionality for the SCAN order routing option, as described
in Nasdaq Rule 4703(a)(7), are similar to the market participants who
use the new RTFY order routing option. While the users of the SCAN
routing strategy are diverse, the users of the 8 a.m. activation
functionality are generally retail focused broker-dealers. RTFY is an
order routing option designed specifically for DROs in order to provide
more opportunities for price improvement to individual retail
investor's orders. Because the firms that choose to utilize the 8 a.m.
activation feature of SCAN are generally firms that represent retail
orders, the Exchange believes that it makes sense to provide this
functionality to the retail firms that make use of the RTFY routing
option. The Exchange proposes to update the fifth bullet point under
Nasdaq Rule 4703(a) for consistency as to this point as well.
    The proposed rule change will allow market participants using RTFY
to benefit by having the added flexibility

to allow their orders to activate at 8:00 a.m. ET in the same way
current users of this functionality do with SCAN. Additionally, Nasdaq
believes that by extending this functionality to the RTFY order routing
option it will support these market participants as they seek ways in
which to more efficiently manage the retail order flow that they submit
to the Exchange.
    The Exchange also proposes to eliminate the final sentence of
Nasdaq Rule 4703(a)(7), which refers to the term ``ESCN''. ESCN denotes
an order using the SCAN routing strategy entered prior to 8:00 a.m. ET
and that is not activated until 8:00 a.m. ET. The inclusion of this
term is unnecessary and its elimination will simplify the rule and
lessen potential confusion for market participants regarding this rule.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder, including the
requirements of Section 6(b) of the Act.\7\ In particular, the Exchange
believes the proposed rule change is consistent with the Section
6(b)(5) \8\ requirements that the rules of an exchange be designed to
promote just and equitable principles of trade, to prevent fraudulent
and manipulative acts and practices, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and to perfect the mechanism for a
free and open market and a national market system, and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Nasdaq believes that the proposed rule change promotes just and
equitable principles of trade, as well as serves to remove impediments
to and to perfect the mechanism for a free and open market and a
national market system, and, in general, to protect investors and the
public interest because it adds flexibility to the recently approved
RTFY routing option. Specifically, the proposed rule change amends both
Nasdaq Rule 4703(a)(7) and the fifth bullet point under Nasdaq Rule
4703(a), which currently apply to the SCAN order routing option, to
also apply to the new RTFY order routing option as well. This added
functionality for RTFY will allow market participants using the RTFY
order routing strategy prior to 8:00 a.m. ET to designate whether their
RTFY orders will activate upon entry or at 8:00 a.m. ET.
    Nasdaq believes that this additional functionality will allow the
Exchange to compete more successfully for retail order flow. The
Exchange bases this upon its determination that the market participants
who currently use the SCAN order routing option and use this
functionality are similar to the market participants who use the new
RTFY order routing option. Nasdaq believes that extending this
functionality to the RTFY order routing option will assist market
participants in efficiently managing the order flow that they submit to
the Exchange.
    This added functionality is an example of different approaches to
market challenges and is what drives innovation, market quality, and
ultimately competition. The Exchange competes vigorously for order flow
in a marketplace where participants have many trading venue choices.
The Exchange believes making this functionality available to market
participants using the RTFY routing option will increase competition by
providing value to retail order firms and their retail investor
customers, which will in turn result in more order flow being sent to
the Exchange.
    The Exchange also believes that its proposal to eliminate the final
sentence of Nasdaq Rule 4703(a)(7) to remove the reference to ``ESCN''
serves to promote just and equitable principles of trade and to protect
investors and the public interest through the elimination of a sentence
that is unnecessary and unhelpful for market participants. Since ESCN
denotes an order using the SCAN routing strategy entered prior to 8:00
a.m. ET and that is not eligible for execution until 8:00 a.m. ET, the
inclusion of this term is no longer necessary and is unhelpful for
market participants. The elimination of this sentence will clarify and
lessen potential confusion for market participants regarding this rule.
    For the above reasons, Nasdaq believes the proposed rule change is
consistent with the requirements of Section 6(b)(5) of the Act.

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

    The [sic] does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. In fact, the
Exchange believes that the functionality in Nasdaq Rule 4703(a)(7)
being made available to market participants using the recently approved
RTFY order routing strategy will promote competition by providing value
to retail order firms and their retail investor customers, which will
in turn result in more order flow being sent to the Exchange. This
development could enhance competition to the benefit of the markets and
investors.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has fulfilled this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the 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.

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 No. SR-NASDAQ-2016-066 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities

and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File No. SR-NASDAQ-2016-066. 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 such filing will also 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 No. SR-NASDAQ-2016-066 and should be
submitted on or before June 10, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-11879 Filed 5-19-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 114 (Tuesday, June 14, 2022)]
[Rules and Regulations]
[Pages 35885-35890]
[FR Doc No: 2022-12749]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0085; Project Identifier MCAI-2021-00498-T;
Amendment 39-22072; AD 2022-12-01]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes.
This AD was prompted by reports of oxygen leaks caused by cracked,
brittle, or broken oxygen hoses that were found during scheduled
maintenance tests of the airplane oxygen system. This AD requires an
inspection of the oxygen hose assembly to determine if an affected part
number is installed, and replacement of affected oxygen hoses. For
certain airplanes, this AD allows repetitive testing of the oxygen
system

until affected hoses are replaced. This AD also prohibits installation
of an affected oxygen hose. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective July 19, 2022.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of July 19,
2022.

ADDRESSES: For service information identified in this final rule,
contact Bombardier Business Aircraft Customer Response Center, 400
C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec H4S 1Y9, Canada;
telephone<PHONE_NUMBER>; email [email protected]; internet
https://www.bombardier.com. You may view this service information at
the FAA, Airworthiness Products Section, Operational Safety Branch,
2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2022-0085.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0085; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Elizabeth Dowling, Aerospace Engineer,
Mechanical Systems and Administrative Services Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued TCCA AD CF-2021-17, dated April 28,
2021 (also referred to as the Mandatory Continuing Airworthiness
Information, or the MCAI), to correct an unsafe condition for certain
Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. You may
examine the MCAI in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0085.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Bombardier,
Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. The NPRM published
in the Federal Register on February 3, 2022 (87 FR 6082). The NPRM was
prompted by reports of oxygen leaks caused by cracked, brittle, or
broken oxygen hoses that were found during scheduled maintenance tests
of the airplane oxygen system. The NPRM proposed to require an
inspection of the oxygen hose assembly to determine if an affected part
number is installed, and replacement of affected oxygen hoses. For
certain airplanes, the NPRM proposed to allow repetitive testing of the
oxygen system until affected hoses are replaced. The NPRM also proposed
to prohibit installation of an affected oxygen hose. The FAA is issuing
this AD to address a leak in the oxygen line, which may result in
failure to provide oxygen to passengers and crew and result in an
oxygen enriched atmosphere creating a fire risk on the airplane. See
the MCAI for additional background information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comments
received on the NPRM and the FAA's response to each comment. Air Line
Pilots Association, International (ALPA), an individual commenter, and
Bombardier indicated their support for the NPRM.

Request To Revise the Conditions for the Aircraft Completion Center
Supplemental Type Certificate (STC) Date

    Bombardier requested that the FAA revise the conditions for the
Aircraft Completion Center STC date. Bombardier stated that the use of
the date when the Aircraft Completion Center STC was issued as
specified in paragraphs (h)(1)(i), (h)(1)(ii) and (h)(3) of the
proposed AD, will, in some cases, be inconsistent with the instructions
given in the service bulletin. Bombardier commented that in cases where
multiple configurations are approved by the Aircraft Completion Center
STC, the date that the STC was issued is not necessarily indicative of
the age of the hoses and should not be used. Bombardier stated that,
for example, STC ST03088NY, was issued April 20, 2012, but has been
used since then to approve many serial-number-specific configurations.
    Bombardier suggested that the date used to determine whether
operators may perform interim inspections and delay hose replacement be
based on one of the following conditions:
     Initial approval of the aircraft completion modification
was demonstrated by a serial number specific to the STC and the date
the STC was issued; or
     Initial approval of the aircraft completion modification
was demonstrated on an STC that approves multiple configurations by the
initial approval date of the serial number specific configuration that
correlates to the date STC was added to the approved configuration
list.
    Bombardier commented that the suggestion is consistent with the
service information provided in Bombardier Advisory Wire AW700-35-0794,
which includes an explanation of how to find the ``Aircraft Completion
STC date'' (expression used in the associated service information), for
cases where Bombardier is the STC holder.
    The FAA disagrees with the commenter's implication that the ability
to delay hose replacement is determined by the date of the STC. The
date as given relative to an STC is only for the optional interim
testing and if all conditions are met; whether an operator may delay
replacement is determined solely based on serial numbers. If an STC is
installed with the referenced hoses, the serial numbers can be checked
on the hoses. The FAA has not changed this AD in this regard.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule as proposed, except for minor
editorial changes. The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Bombardier has issued the following service information.
     Bombardier Service Bulletin 700-1A11-35-014, Revision 01,
dated February 12, 2021.
     Bombardier Service Bulletin 700-35-015, Revision 01, dated
February 12, 2021.
     Bombardier Service Bulletin 700-35-5005, Revision 01,
dated February 12, 2021.

     Bombardier Service Bulletin 700-35-6005, Revision 01,
dated February 12, 2021.
     Bombardier Service Bulletin 700-35-6501, Revision 01,
dated February 12, 2021.
    This service information describes procedures for doing an
inspection of the oxygen hose assembly installations to determine if a
part number within the series O2C20T1 is installed, and replacing the
oxygen hose if necessary. For certain airplanes, the service
information specifies optional repetitive testing of the oxygen system
that would allow for delay of the replacement. These documents are
distinct since they apply to different airplane serial numbers.
    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

    The FAA estimates that this AD will affect 409 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
               Labor cost                   Parts cost         Cost per product         Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 36 work-hours x $85 per hour = Up               $0  Up to $3,060..............  Up to $1,251,540.
 to $3,060.
----------------------------------------------------------------------------------------------------------------

                  Estimated Costs for Optional Actions
------------------------------------------------------------------------
           Labor cost                 Parts cost       Cost per product
------------------------------------------------------------------------
Up to 25 work-hours x $85 per     Up to $125........  Up to $2,250.
 hour = Up to $2,125.
------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

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.
    The FAA is 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) Will not affect intrastate aviation in Alaska, and
    (3) 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:

2022-12-01 Bombardier, Inc.: Amendment 39-22072; Docket No. FAA-
2022-0085; Project Identifier MCAI-2021-00498-T.

(a) Effective Date

    This airworthiness directive (AD) is effective July 19, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model BD-700-1A10 and BD-
700-1A11 airplanes, certificated in any category, serial numbers
9002 through 9879 inclusive and 9998.

(d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

(e) Unsafe Condition

    This AD was prompted by reports of oxygen leaks caused by
cracked, brittle or broken oxygen hoses that were found during
scheduled maintenance tests of the airplane oxygen system. The FAA
is issuing this AD to address a leak in the oxygen line, which may
result in failure to provide oxygen to passengers and crew and
result in an oxygen enriched atmosphere creating a fire risk on the
airplane.

(f) Compliance

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

(g) Inspection and Replacement

    Within 6 months after the effective date of this AD: Do an
inspection of the oxygen hose assembly to determine if any hose
having a part number (P/N) in the O2C20T1 series is installed, in
accordance with the Accomplishment Instructions of the applicable
service information specified in figure 1 to paragraph (g) of this
AD. If P/N O2C20T1 series is installed, or if any test fails as
specified in paragraph (h) of this AD, before further flight,
replace all the oxygen hoses, in accordance with the Accomplishment
Instructions of the applicable service information specified in
figure 1 to paragraph (g) of this AD.
BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TR14JN22.000

(h) Optional Interim Testing for Certain Airplanes

    For airplanes identified in figure 2 of paragraph (h) of this
AD: The oxygen hose replacement, if required by paragraph (g) of
this AD, may be delayed if all conditions specified in paragraphs
(h)(1) through (3) of this AD are met.
    (1) The oxygen system is tested at the applicable times
specified in paragraph (h)(1)(i) or (ii) of this AD, in accordance
with the Accomplishment Instructions of the applicable service
information specified in figure 2 to paragraph (h) of this AD.
    (i) If the Aircraft Completion Center Supplemental Type
Certificate (STC) for the passenger cabin interior was issued within
5 years before the effective date of this AD: The oxygen system is
tested within 6 months after the effective date of this AD, and
thereafter at intervals not to exceed 30 months.
    (ii) If the Aircraft Completion Center STC for the passenger
cabin interior was issued 5 years or more before the effective date
of this AD: The oxygen system is tested within 6 months after the
effective date of this AD, and thereafter at intervals not to exceed
15 months.
    (2) All P/N O2C20T1 series hoses are replaced before further
flight as specified in paragraph (g) of this AD after any hose fails
any test.

    (3) Except as specified by paragraph (h)(2) of this AD, all P/N
O2C20T1 series hoses are replaced within 10 years after issuance of
the Aircraft Completion Center STC for the passenger cabin interior
as specified in paragraph (g) of this AD provided that all P/N
O2C20T1 series hoses in the flight compartment and the third crew
(left-hand side enclosure) are replaced within 6 months after the
effective date of this AD.
[GRAPHIC] [TIFF OMITTED] TR14JN22.001

BILLING CODE 4910-13-C

(i) Parts Installation Prohibition

    As of the effective date of this AD, no person may install an
oxygen hose assembly having a P/N in the O2C20T1 series on any
airplane.

(j) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using the applicable service information specified
in paragraphs (j)(1) through (5) of this AD.
    (1) Bombardier Service Bulletin 700-1A11-35-014, dated September
28, 2020.
    (2) Bombardier Service Bulletin 700-35-015, dated September 28,
2020.
    (3) Bombardier Service Bulletin 700-35-5005, dated September 28,
2020.
    (4) Bombardier Service Bulletin 700-35-6005, dated September 28,
2020.
    (5) Bombardier Service Bulletin 700-35-6501, dated September 28,
2020.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) TCCA AD CF-2021-17, dated April 28, 2021, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2022-0085.
    (2) For more information about this AD, contact Elizabeth
Dowling, Aerospace Engineer, Mechanical Systems and Administrative
Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue,
Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax 516-794-
5531; email [email protected].

(m) 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 this AD specifies otherwise.
    (i) Bombardier Service Bulletin 700-1A11-35-014, Revision 01,
dated February 12, 2021.
    (ii) Bombardier Service Bulletin 700-35-015, Revision 01, dated
February 12, 2021.
    (iii) Bombardier Service Bulletin 700-35-5005, Revision 01,
dated February 12, 2021.
    (iv) Bombardier Service Bulletin 700-35-6005, Revision 01, dated
February 12, 2021.
    (v) Bombardier Service Bulletin 700-35-6501, Revision 01, dated
February 12, 2021.
    (3) For service information identified in this AD, contact
Bombardier Business

Aircraft Customer Response Center, 400 C[ocirc]te-Vertu Road West,
Dorval, Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; email
[email protected]; internet https://www.bombardier.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (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, email [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 25, 2022.
Ross Landes,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-12749 Filed 6-13-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 9, 2009 (Volume 74, Number 215)]
[Notices]
[Page 57669]
[DOCID:fr09no09-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD09-11-000]

Natural Gas Infrastructure and Opportunities for Improved
Efficiency; Notice of Conference Postponement

November 2, 2009.
    Take notice that the public conference referenced in the above
docket and initially noticed on September 21, 2009 will be postponed
until January. Once the conference is rescheduled, a subsequent
scheduling notice will be issued.
    For more information about the conference or any questions, please
contact Pamela Romano at<PHONE_NUMBER> (pamela.romano@ferc.gov).

Kimberly D. Bose,
Secretary.
[FR Doc. E9-26889 Filed 11-6-09; 8:45 am]

BILLING CODE 6717-01-P