1 Formetanate HCl Overview of Risk Assessment March 11, 2004 Introduction This document summarizes EPA's human health, environmental fate, and ecological risk findings for the pesticide formetanate hydrochloride ( HCl). These findings are presented fully in the human health risk assessment document " HED Revised Risk Assessment for Formetanate Hydrochloride" dated June 4, 2003; and the " EFED Science Chapter for the Formetanate Hydrochloride Reregistration Eligibility Document", dated October 22, 2003.

Formetanate HCl is a carbamate insecticide, and it has been determined that N methyl carbamates share a common mechanism of toxicity: the inhibition of cholinesterase. As required by the Food Quality Protection Act ( FQPA), EPA will consider the cumulative risks from food, water and non occupational exposure resulting from all revelant uses of the group of N methyl carbamates. The risk estimates summarized in this document, however, are for formetanate HCl alone.

In October 1999, a Memorandum of Agreement ( MOA) between the registrant and the Agency was signed because EPA was concerned that formetanate residues from the current use pattern presented acute dietary risks. In addition, EPA was also concerned with worker and ecological risks ( These findings are presented fully in the human health risk assessment document " HED Preliminary Risk Assessment for Formetanate Hydrochloride" dated April 6, 1999; and EFED Science Chapter for the Formetanate Hydrochloride Reregistration Eligibility Document dated September 29, 1997).

For acute dietary risks, the Agency concluded if changes to application rates and/ or timing to citrus, stone, and pome fruits were to result in non detectable residues, risk estimates would probably be below EPA's level of concern. The MOA stipulated labeling amendments aimed at lowering application rates, increasing pre harvest intervals and limiting uses to certain crops in an effort to reduce exposures associated with formetanate uses. In addition, the registrant would supply the Agency with field trial data for citrus, nectarines, peaches, and apples. Further, they would submit acute, subchronic, and developmental neurotoxicity studies for the hazard assessment.

Finally, the MOA stipulated that if, on the basis of new data, EPA determines that residues exceed 100% of the acute Population Adjusted Dose ( aPAD), the Registrant may either withdraw the registrations or amend them to demonstrate that the formetanate HCl residues on food do not exceed 100% of the aPAD. 2 The risk assessments summarized here are based on the new application rates/ timing and toxicity information submitted in response to the MOA and consider only those uses allowed under the MOA. The purpose of this overview is to assist the reader in understanding the conclusions reached in the risk assessments by identifying the key features and findings of each.

Use Profile $ Insecticide: Formetanate HCl is a carbamate miticide/ insecticide used on alfalfa ( grown for seed), apples, pears, nectarines, peaches, and assorted citrus fruits. There are no residential uses for formetanate products.

$ Target Pests: Registered products containing formetanate HCl are intended for application on fruit and alfalfa to control lygus bugs, mites, stink bugs, and thrips.

$ Formulations: Formetanate HCl is formulated as a manufacturing product ( 92 percent active ingredient), and as a wettable powder in water soluble packaging ( 92 percent active ingredient).

$ Method of Application: Formetanate HCl can be applied with aerial or ground equipment, such as groundboom sprayers and airblast sprayers. Formetanate HCl is labeled for use on tree fruits at 1.15 lb ai/ A and for alfalfa at a maximum of 0.92 lb ai/ A.

$ Use Summary: Based on Agency data, the average total annual domestic usage of formetanate was approximately 60,000 pounds a. i. on about 65,000 acres. The predominant usage is in California. The highest usage, by crop, is on nectarines where it is 50 70% crop treated.

$ Technical Registrant: Gowan Company.

Human Health Risk Assessment Results of the MOA Agreement Between 2000 2002, the registrant submitted field trial data using the new application rate/ timing for formetanate. New labels were approved on January 27, 2000 ( they were submitted to EPA on November 23, 1999) to reflect the amendments that were set forth by the MOA. Acute and subchronic neurotoxicity data were submitted for Agency review. EPA has since concluded that a developmental neurotoxicity study in rats is not required but that comparative cholinesterase assay studies are needed.

USDA's Pesticide Data Program ( PDP), upon Agency request, collected and analyzed 3 oranges, apples and nectarines in 2000 and 2001 in order to determine formetanate residues resulting from the new lower application rates mandated by the MOA. 2001 PDP data were used in the dietary assessment because it is unlikely that label changes were in effect for the full 2000 growing season. Limited field trial data were available at the new application rates for nectarine, peach, apple, pear, orange, grapefruit, and lemon and these data showed residues from applications made in accordance to the MOA.

Hazard Uncertainties The toxicology assessment for formetanate has changed from the 1999 Human Health Risk Assessment based on the submitted data. In particular, there were significant changes in the endpoint and uncertainty factors ( See Table 1 below). The previous endpoint was 1 mg/ kg/ day based on cholinergic effects ( salivation and tremors) from a developmental toxicity study in rats. The current NOAEL, based on the new acute neurotoxicity study, is 0.1 mg/ kg/ day where the endpoint is cholinesterase inhibition.

The Uncertainty Factors in 1999 were 900x. There was a 10x for interspecies, 10x for intraspecies, 3x for lack of a true NOAEL ( since cholinesterase inhibition was not measured) and a 3x for the FQPA safety factor because data gaps existed for acute and subchronic neurotoxicity studies in rats. The registrant provided acute and subchronic neurotoxicity studies, so the 3x FQPA safety factor was removed. In addition, since the acute neurotoxicity study measured cholinesterase inhibition, the 3x for lack of true NOAEL was removed.

However, formetanate has been demonstrated to be an inhibitor of cholinesterase and at higher doses to demonstrate signs of toxicity related to cholinesterase inhibition. Thus, based on structure activity relationships and the demonstration of toxicity related to cholinesterase inhibition there is a need for additional testing to evaluate the susceptibility of newborns to cholinesterase inhibition. Therefore, a special study that compares cholinesterase inhibition in adult rats with neonatal rats is required to determine potential sensitivity of the young compared to the adults. Until this data is submitted, the Agency concluded that a 10x Database Uncertainty Factor is warranted. Available data provide no basis to support reduction or removal of the Uncertainty Factor.

Exposure Uncertainties 2001 PDP data reflects current labels. However, they may also reflect some carryover use ( i. e., applications from product prior to label changes). EPA is analyzing 2001 and 2002 California use data ( for nectarines only) in an attempt to resolve this uncertainty. 4 Acute Dietary ( Food) Risk Acute dietary risk is calculated considering the toxicity of a chemical, what is eaten by individuals in one day and residue values for various foods. A risk estimate that is less than 100% of the acute Population Adjusted Dose ( aPAD) ( the dose at which an individual could be exposed on any given day and no adverse health effects would be expected) does not exceed the Agency's risk concern.

Table 1. Formetanate HCl : Summary of the 2003 Toxicology Endpoint Selection Acute Dietary Endpoint Exposure Scenario Dose Endpoint Study Acute Dietary ( 2003) NOAEL= 0.1 mg/ kg Whole Blood and Brain Cholinesterase Inhibition Acute Neurotoxicity Study UF = 1000x Acute PAD = 0.0001 mg/ kg/ day $ The acute dietary risk endpoint is based the inhibition of whole blood and brain cholinesterase activity in rats at a NOAEL of 0.1 mg/ kg/ day. This NOAEL is a 10 fold decrease from the endpoint that was established in 1999 ( 1 mg/ kg/ day).

$ The Uncertainty Factor is 1000. 10x interspecies extrapolation, 10x for intra species variability, and 10x for an additional database uncertainty factor to account for the lack of a special comparative cholinesterase study in adults versus young.

$ The acute RfD is calculated to be 0.0001 mg/ kg/ day. Because the FQPA safety factor was reduced to 1x, the acute and chronic RfDs are equal to the acute and chronic PADs, respectively. The acute Population Adjusted Dose ( aPAD) is 0.0001 mg/ kg/ day.

$ The Dietary Evaluation Exposure Model software with the Food Commodity Intake Database ( DEEM FCIDTM, Version 1.3) was used to estimate acute dietary exposure in a probabilistic mode.

$ The acute dietary risk analysis evaluates individual food consumption as reported by respondents in the USDA 1994 1996 and 1998 Continuing Survey of Food Intake by Individuals ( CSFII) and accumulates exposure to the chemical for each commodity.

$ This analysis is refined in that it uses 2001 monitoring data from USDA's Pesticide Data Program to calculate anticipated residues for use in acute dietary analysis. Data on the percentage of crop treated were incorporated for all commodities included in the dietary assessment.

$ The acute dietary risk ( food) of formetanate HCl is above the Agency's level of concern 5 ( i. e., greater than 100% of the aPAD is utilized) for the general U. S. population and all population subgroups, including infants and children at the 99.9th percentile of exposure. The most highly exposed subgroup was infants at 3300% of the aPAD.

Table 2. Formetanate HCl: Acute Dietary Risk % aPAD at 99.9th Percentile Population Subgroup % aPAD General U. S. Population 640 All Infants (< 1 year old) 3300 Children 1 2 years old 2200 Children 3 5 years old 1600 Children 6 12 years old 870 Youth 13 19 years old 340 Adults 20 49 years old 460 Females 13 49 years old 520 Adults 50+ years old 530 Chronic Dietary ( Food) Risk Chronic dietary risk is calculated by using the average consumption value for food and average residue values on those foods over a 70 year lifetime. A risk estimate that is less than 100% of the chronic PAD ( the dose at which an individual could be exposed over the course of a lifetime and no adverse health effects would be expected) does not exceed the Agency's risk concern. The cPAD is the chronic reference dose ( cRfD) adjusted for the FQPA Safety Factor. As noted above, since the FQPA Safety Factor equals 1, they are the same.

Chronic risk estimates from exposures in food to formetanate HCl are below the Agency's level of concern for the general U. S. population and all population subgroups. The most highly exposed population subgroup was infants < 1 year old at 10% of the cPAD ( See Table 3).

$ Since the clinical signs following acute and chronic exposure to formetanate in rats and dogs are consistent with cholinesterase inhibition, the same endpoint was used. The chronic dietary risk endpoint is based the inhibition of whole blood and brain cholinesterase activity in rats at a NOAEL of 0.1 mg/ kg/ day. These effects were observed at 1 mg/ kg/ day.

$ As stated above for the acute dietary risk, the Uncertainty Factor is 1000.

$ The chronic RfD is calculated to be 0.0001 mg/ kg/ day. 6 $ The Dietary Evaluation Exposure Model software with the Food Commodity Intake Database ( DEEM FCIDTM, Version 1.3) was used to estimate chronic dietary exposure which incorporated consumption data from CSFII 1994 1996 and 1998. Anticipated residues from 2001 USDA PDP monitoring data, estimated percent crop treated information and processing factors were used.

Drinking Water Dietary Risk Drinking water exposure to pesticides can occur through groundwater and surface water contamination. EPA considers both acute ( one day) and chronic ( multiple year) drinking water risks, and uses either modeling or monitoring data, if available, to estimate those risks. Modeling is carried out in tiers of further refinement, but is designed to provide a high end estimate of exposure. To determine the maximum allowable contribution from water in the diet, EPA first calculates the overall allowable risk and subtracts the amount contributed by food to determine a " drinking water level of comparison" ( DWLOC). This is then compared to estimated concentrations in water to ascertain whether modeled or monitoring levels in water exceed this level of risk. The acute DWLOC estimate could not be calculated for formetanate HCl since more than the allowable portion of risk was contributed by residues in food.

$ Formetanate HCl is moderately mobile but degrades quickly in aquatic environments.

$ Drinking water concentrations for ground water were estimated using model estimates from the SCI GROW 2.3 model. Drinking water concentrations for surface water were estimated using the Tier 2 PRZM/ EXAMS model. No ground water or surface water monitoring data were available.

Acute Exposures $ Because acute exposure to residues of formetanate HCl from food alone exceeds EPA's level of concern, additional exposure to formetanate HCl in drinking water would cause risk estimates to further exceed levels of concern. Effectively, until the acute dietary ( food) exposure to formetanate HCl is reduced, DWLOCs are assumed to be zero.

$ Potential exposure to formetanate HCl from drinking water derived from ground water sources results in an acute estimated environmental concentration ( EEC) of 0.29 ppb.

$ Potential exposure to formetanate HCl from drinking water derived from surface water results in an acute EEC of 7.68 ppb.

Chronic Exposures 7 Potential exposure to formetanate from drinking water derived from surface water results in a chronic EEC of 0.08 ppb. For groundwater modeling, degradation is assumed to be negligible. Therefore, the chronic groundwater EEC is 0.29 ppb. All EECs are less than the chronic DWLOCs for each population. Therefore, the Agency is not concerned with potential chronic exposure to formetanate through surface and ground water.

Table 3. Formetanate: Chronic Dietary Risk % cPAD at 99.9th Percentile and Drinking Water DWLOC and EEC Comparisons Population Subgroup % aPAD DWLOC EECs ( ppb)

Chronic Ground Water Surface Water General U. S. Population 3 3.4 0.29 0.08 All Infants (< 1 year old) 10 0.90 Children 1 2 years old 9 0.91 Children 3 5 years old 8 0.92 Children 6 12 years old 4 0.96 Youth 13 19 years old 1 3.4 Adults 20 49 years old 2 3.4 Females 13 49 years old 2 2.9 Adults 50+ years old 2 3.4 Cancer Risk Formetanate HCl has been classified a Group " E" carcinogen ( no evidence of carcinogenicity). Therefore, risks from formetanate are below the EPA's level of concern for cancer.

Residential Risk Currently, there are no registered residential uses for formetanate HCl.

Aggregate Risk Acute exposure to residues of formetanate HCl from food alone exceeds the Agency's level of concern. Additional exposure to formetanate HCl in drinking water would cause risk estimates to further exceed levels of concern. Until the acute dietary ( food) exposure to formetanate is reduced, DWLOCs are assumed to be zero. Therefore, acute aggregate risks exceed EPA's level of concern.

Chronic aggregate risk estimates are below the Agency's level of concern for the general 8 U. S. population and all population subgroups.

Occupational Risk Workers can be exposed to a pesticide through mixing, loading, applying, flagging, and otherwise handling a pesticide as well as reentering previously treated sites. Worker risk is expressed as a Margin of Exposure ( MOE) which determines how close the occupational exposure comes to an No Observed Adverse Effect Level ( NOAEL), which is the highest dose given in studies at which no significant toxic effects were observed. For formetanate, MOEs less than 100 exceed the Agency's level of concern for risk for short and intermediate term occupational dermal and inhalation exposure ( 1 30 days and 30 days to several months, respectively).

Restricted entry intervals ( REIs) are calculated to determine the minimum length of time required following an application before it is considered safe for workers to reenter a treated area. REIs are developed for different crops and different worker activities ( i. e., scouting, harvesting, etc.) using an MOE based approach. For this assessment, REIs are calculated in days.

Short Term and Intermediate Term Handler Risks $ Formetanate use patterns show that both short term and intermediate term exposure to handlers is possible.

$ The short term and intermediate endpoints are the same. The NOAEL is 10 mg/ kg/ day and is based on a 21 day dermal study in rats. No dermal absorption adjustment is required since the endpoint is based on a dermal study.

$ The short term and intermediate term inhalation endpoints are also the same. The NOAEL is 0.1 mg/ kg/ day and is based on the acute neurotoxicity study in rats discussed above. An oral endpoint was chosen because of a lack of inhalation toxicity studies. An absorption factor of 100% is assumed for exposure via the inhalation route.

$ No chemical specific handler data were submitted, so short term and intermediate term dermal and inhalation exposures for handlers were developed using the Pesticide Handler Exposure Database ( PHED) Version 1.1.

° Most scenarios had MOEs above 100 at maximum PPE ( coveralls, hood, gloves, and respirator) or maximum PPE using engineering controls. The exceptions were at maximum PPE, mixing and loading for alfalfa by aerial application ( MOE = 57) and airblast applicators for orchards ( MOE= 73). With engineering controls, EPA has concerns for aerial applicators for alfalfa ( MOE = 54). The following tables summarize the risks to handlers by crop type: Table 4: Mixer Loader, Applicator, Flagger Risk Estimates using WP in Water Soluble Packets ( WSP plus Double Layer Protection, Gloves, Dust/ Mist Respirator 1Refer to Table 5.

2 Engineering control exposures represent long pants and long sleeved shirts. For mixers and loaders, chemical resistant gloves are also included.

9 Exposure Scenario Crop Application Rate lb ai/ A Dermal MOE Inhalation MOE Total MOE Mixer Loader ( Wettable Powders)

Aerial Pome, Stone, Citrus 1.15 305 360 170 Aerial Alfalfa for seed 0.92 110 130 57 Airblast Pome, Stone, Citrus 1.15 2700 3200 1500 Groundboom Alfalfa 0.92 670 709 340 Applicator ( Sprays)

Aerial Alfalfa 0.92 Not Practical1 Not Practical Not Practical Aerial Pome, Stone, Citrus 1.15 Not Practical Not Practical Not Practical Airblast Pome, Stone, Citrus 1.15 130 170 73 Groundboom Alfalfa for seed 0.92 350 250 150 Flagger Aerial Alfalfa for seed 0.92 220 310 130 Aerial Stone, Pome, Citrus 1.15 170 250 100 Table 5: Formetanate HCl. Mixer/ Loader, Applicator, & Flagger Risk Estimates: Using Engineering Controls: WP in Water Soluble Bags ( WSB); Closed Cockpit, Closed Cab Tractors2 Exposure Scenario Crop Application Rate ( lb ai/ A) Dermal MOE Inhalation MOE Total MOE Mixer Loader ( Wettable Powder)

Aerial Pome, Stone, Citrus 1.15 180 72 51 Aerial Alfalfa for seed 0.92 65 26 19 Airblast Pome, Stone, Citrus 1.15 1600 630 450 Exposure Scenario Crop Application Rate ( lb ai/ A) Dermal MOE Inhalation MOE Total MOE 10 Groundboom Alfalfa 0.92 390 160 110 Applicator ( Sprays)

Aerial Alfalfa 0.92 130 93 54 Aerial Pome, Stone, Citrus 1.15 350 260 150 Airblast Pome, Stone, Citrus 1.15 800 340 240 Groundboom Alfalfa for seed 0.92 760 890 410 Flagger Aerial Alfalfa for seed 0.92 9900 3100 2400 Aerial Stone, Pome, Citrus 1.15 7900 2500 1900 Post Application Risk Estimates There is potential exposure to persons entering previously treated sites ( e. g. scouts and harvesters). The use of standard transfer coefficients was used to represent transfer during worker activities for each of the crops. Dislodgeable foliar residue ( DFR) values are based on a formetanate HCl study on citrus. The citrus DFR values were then used as surrogate data for all other crops.

$ Formetanate HCl use patterns show that both short term ( 1 30 days) and intermediateterm ( 1 month to 6 months) exposure is possible for post application exposures. Therefore, risk estimates were calculated for both short term and intermediate term exposures.

$ The Agency has adopted a method of clustering crops, crop growth stages, and postapplication activities into groups that are expected to result in comparable exposure. Empirically derived transfer coefficients have then been applied to activities occurring in the defined crop groups. The transfer coefficient defines the rate of transfer from foliar residue to skin that occurs during a particular activity.

$ Dislodgeable Foliar Residue ( DFR) data were submitted for citrus. This data was translated for use on pome and stone fruit. The assessment was adjusted to reflect the current maximum use rate. In addition, this assessment is assumed to be representative for all registered tree crops. 11 $ No residue data were submitted for alfalfa. Data from the citrus study was translated for alfalfa. The Agency acknowledges that the citrus residue data are not readily comparable to alfalfa residues. However, the calculated exposure using the surrogate data is being used as a screening level assessment and is considered a conservative estimate for alfalfa.

$ For worker re entry risk, the calculated REI represents the day on which the MOE is greater than or equal to 100. MOEs were greater than or equal to a 100 by day 12 for evergreen fruit trees, day 8 for deciduous fruit trees, and day 9 for alfalfa.

Table 6. Formetanate HCl. Summary of Postapplication Risks Crops Re entry Day with Acceptable MOEs > 100 Alfalfa 9 Fruit Trees, Deciduous 8 Fruit Trees, Evergreen 12 Ecological Risk Assessment To estimate potential ecological risks, EPA integrates the results of exposure and ecotoxicity using the quotient method. Risk quotients ( RQs) are calculated by dividing estimated environmental concentrations ( EECs) of the pesticide by acute and chronic toxicity values. EECs are based on the maximum application rates for that pesticide.

Risk quotients are then compared to the Agency's level of concern ( LOCs). These LOCs ( Table 7) are used to analyze potential risk to non target organisms and to determine the need for regulatory action. Risk characterization provides further information on the likelihood of adverse effects occurring by considering the fate of the chemical in the environment, communities and species potentially at risk, their spatial and temporal distributions, and the nature of the effects observed in studies. If the RQ is higher than the LOC, the Agency may have a concern.

Table 7. Formetanate Hcl: Risk Presumptions for Terrestrial and Aquatic Animals Risk Presumption LOC terrestrial animals LOC aquatic animals 12 Acute High Risk there is potential for acute risk based on LD50s ( i. e., endpoint is death to 50% of tested population) 0.5 0.5 Acute Restricted Use  there is potential for acute risk, but may be mitigated through restricted use classification, 0.2 0.1 Acute Endangered Species  endangered species may be adversely affected 0.1 0.05 Chronic Risk  there is potential for chronic risk; effects are varied, but often include reproduction or survival effects. 1 1 Environmental Fate Information $ Formetanate HCl is not a persistent pesticide under normal use conditions. The primary routes of dissipation appear to be hydrolysis under neutral and alkaline conditions as well as microbial degradation. Formetanate HCl hydrolyzes with a half life of less than a 1 day. Photolysis may be an important route of degradation in neutral and alkaline waters and on soil surfaces with half lives ranging from less than 1 to 3 days. Formetanate is readily biodegradable with a soil metabolism half life of less than one week.

Nontarget Terrestrial Animal Risk $ Avian acute risks from a single application were generally low. However, endangered species risks were above the Agency's level of concern with a maximum RQ of 0.20.

$ Avian chronic risks from a single application were above EPA's level of concern for most uses. Body weight and reproduction effects were seen at 480 ppm treatment levels. Chronic RQs ranged from 0.26 to 5.21.

$ For small mammals ( 15g), acute risks were above the Agency's level of concern with RQ estimates up to 1.11. For medium size ( 35g) animals, acute risks were below the level of concern. However acute restricted use and endangered species risks were above the EPA's level of concern with RQ estimates ranging up to 0.24.

$ Mammalian chronic risks from a single application were above EPA's level of concern for most uses. Chronic RQs ranged from 1.38 to 27.60. These results were based on a chronic dog study with a NOAEL of 10 ppm based on brain cholinesterase inhibition.

$ Formetanate HCl is practically non toxic to honeybees.

Nontarget Aquatic Animal Risk $ Acute and chronic risks for freshwater fish at the single application rate are below the Agency's level of concern for all uses.

$ Acute and chronic risks for freshwater invertebrates were generally below the level of 13 concern at the single application rate. RQ risk estimates exceeded the level of concern for use on peaches ( 1.12). The effect noted for chronic risk was larval survival.

$ Acute risks for estuarine/ marine invertebrates at the single application rate were below EPA's level of concern. No data were submitted to estimate chronic risks.

Summary of Pending Data Toxicology The acute toxicity data base is currently supported by older studies which are invalid. Replacement studies for the following acute toxicity studies are required:

$ 870.1100 Acute oral toxicity $ 870.1200 Acute dermal toxicity $ 870.1300 Acute inhalation toxicity $ 870.2500 Primary dermal irritation $ Non Guideline Special study for comparative ( dams vs. pups) inhibition of cholinesterase. The protocol for this non guideline study should be submitted to OPP for review prior to initiating the study.

$ 870.3465 28 day Inhalation Toxicity Study.

Chemistry Residue Chemistry Deficiencies $ 860.1300 Nature of the Residue $ 860.1500 Crop Field Trials Additional field trail data ( apple, pear, peach, and citrus) are needed to reassess tolerances. For nectarines, details pertaining to the field procedures used in the at harvest study ( i. e., application method and timing, equipment, spray volumes, tank mix adjuvants) and multiple application rates must be provided.

Product Chemistry ° 830.7050 Ultraviolet/ Visible Absorption ° 830.1550 Product Identity and Disclosure of Ingredients 14 ° 830.1750 Certified Limits ° 830.1800 Enforcement Analytical Method ° Gowan Co. must either certify that the suppliers of beginning materials and the manufacturing process for the formetanate hydrochloride MP have not changed since the last comprehensive product chemistry review or submit a complete updated product chemistry data package.

Environmental Fate $ 835.4100 Aerobic Soil Metabolism $ 835.4200 Anaerobic Soil Metabolism


[Federal Register: December 6, 2006 (Volume 71, Number 234)]
[Notices]
[Page 70751-70752]
[DOCID:fr06de06-43]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-75-000]

Northern Natural Gas Company; Notice of Petition for Limited
Waiver

November 29, 2006.
    Take notice that on November 21, 2006, Northern Natural Gas Company
(Northern) tendered for filing a petition for a limited waiver of its
FERC Gas Tariff in order to allow Northern to resolve an erroneously
recorded imbalance variance for the month of October 2006.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

    Comment Dated: 5 p.m. eastern time December 6, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-20604 Filed 12-5-06; 8:45 am]

BILLING CODE 6717-01-P


has determined, with the concurrence of the Administrator of the Office
of Information and Regulatory Affairs of OMB, that this rule is not a
``major rule'' as defined in section 351 of the Small Business
Regulatory Enforcement Fairness Act of 1996.\107\ This final rule is
being submitted to the Senate, House, and Government Accountability
Office.
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    \107\ 5 U.S.C. 804(2).

    By the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.

    Note:  This appendix will not appear in the Code of Federal
Regulations.

Appendix

------------------------------------------------------------------------
           Abbreviation                           Commenter
------------------------------------------------------------------------
                           Initial Commenters
------------------------------------------------------------------------
APS...............................  Arizona Public Service Company.
Associations......................  Edison Electric Institute, Electric
                                     Power Supply Association,
                                     Electricity Consumers Resource
                                     Council.
BPA...............................  Bonneville Power Administration.
CEA...............................  Canadian Electricity Association.
Duke..............................   Duke Energy Corporation.
Entergy...........................  Entergy.
Foundation........................  Foundation for Resilient Societies.
GridWise..........................  GridWise Alliance.
G&T Cooperatives..................  Associated Electric Cooperative,
                                     Inc., Basin Electric Power
                                     Cooperative, and Tri-State
                                     Generation and Transmission
                                     Association, Inc.
Idaho Power.......................  Idaho Power Company.
ITC...............................  International Transmission Company.
KCP&L.............................  Kansas City Power & Light Company
                                     and KCP&L Greater Missouri
                                     Operations Company.
MISO..............................  Midcontinent Independent System
                                     Operator, Inc.
NARUC.............................  National Association of Regulatory
                                     Utility Commissioners.
NEMA..............................  National Electrical Manufactures
                                     Association.
NERC..............................  North American Electric Reliability
                                     Corporation.
NU................................  Utilities Northeast Utilities
                                     System.
NYPSC.............................  New York Public Service Commission.
Ohio PUC..........................  Public Utilities Commission of Ohio.
Oncor.............................  Oncor Electric Delivery Company LLC.
Pa PUC............................  Pennsylvania Public Utility
                                     Commission.
Paschall..........................  Roger Paschall.
Pepco.............................  Pepco Holdings, Inc.
Reclamation.......................  U.S. Department of Interior, Bureau
                                     of Reclamation.
Seattle...........................  City of Seattle.

SCE...............................  Southern California Edison.
SDG&E.............................  San Diego Gas & Electric.
SIA...............................  Security Industry Association.
Southern..........................  Southern Company Services, Inc.
TAPS..............................  Transmission Access Policy Study
                                     Group.
TVA...............................  Tennessee Valley Authority.
Trade Associations................  American Public Power Association,
                                     Large Public Power Council,
                                     National Rural Electric Cooperative
                                     Association.
Xcel..............................  Xcel Energy Services Inc.
------------------------------------------------------------------------
                            Reply Commenters
------------------------------------------------------------------------
Foundation........................  Foundation for Resilient Societies.
ITC...............................  International Transmission Company.
NIPSCO............................  Northern Indiana Public Service
                                     Company.
SmartSenseCom.....................  SmartSenseCom, Inc.
SWTDUG............................  Southwest Transmission Dependent
                                     Utility Group.
Tallahassee.......................  City of Tallahassee.
------------------------------------------------------------------------

[FR Doc. 2014-27908 Filed 11-24-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41970-41971]
[FR Doc No: 2023-13733]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2226]

Gemini Laboratories, LLC, et al.; Withdrawal of Approval of One
New Drug Application for OXANDRIN (Oxandrolone) Tablets and Four
Abbreviated New Drug Applications for Oxandrolone Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of the new drug application (NDA) for OXANDRIN
(oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, held by Gemini
Laboratories, LLC (Gemini). Gemini

voluntarily requested withdrawal of this application and waived its
opportunity for a hearing. In addition, FDA is withdrawing approval of
four abbreviated new drug applications (ANDAs) for oxandrolone tablets
from multiple ANDA holders. Upsher-Smith Laboratories, LLC (Upsher-
Smith), Par Pharmaceutical, Inc. (Par), and Sandoz Inc. (Sandoz)
voluntarily requested withdrawal of their respective applications and
waived their opportunity for a hearing.

DATES: Approval is withdrawn as of June 28, 2023.

FOR FURTHER INFORMATION CONTACT: Alexandria Fujisaki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-
796-3600, [email protected].

SUPPLEMENTARY INFORMATION: The applicants and their respective drugs
and applications are included in the following table.

------------------------------------------------------------------------
     Application No.                Drug                 Applicant
------------------------------------------------------------------------
NDA 013718...............  Oxandrin (oxandrolone)  Gemini, 400 Crossing
                            Tablets, 2.5 mg and     Blvd., 5th Floor,
                            10 mg.                  Bridgewater, NJ
                                                    08807.
ANDA 076761..............  Oxandrolone Tablets,    Upsher-Smith
                            2.5 mg.                 Laboratories, LLC,
                                                    6701 Evenstad Dr.,
                                                    Maple Grove, MN
                                                    55369.
ANDA 076897..............  Oxandrolone Tablets,    Sandoz Inc., 100
                            2.5 mg and 10 mg.       College Rd. West,
                                                    Princeton, NJ 08540.
ANDA 077827..............  Oxandrolone Tablets,    Par Pharmaceutical,
                            2.5 mg and 10 mg.       Inc., c/o Endo, 1400
                                                    Atwater Dr.,
                                                    Malvern, PA 19355.
ANDA 078033..............  Oxandrolone Tablets,    Upsher-Smith
                            10 mg.                  Laboratories, LLC,
                                                    6701 Evenstad Dr.,
                                                    Maple Grove, MN
                                                    55369.
------------------------------------------------------------------------

    In a letter dated March 26, 2019, Gemini requested that FDA
withdraw approval of NDA 013718 for OXANDRIN (oxandrolone) tablets, 2.5
mg and 10 mg, under Sec.  314.150(c) (21 CFR 314.150(c)), stating that
the product was no longer being marketed. Subsequently, on December 16,
2022, FDA notified Gemini and other holders of approved applications
that the Agency believes a potential problem associated with
oxandrolone tablets is sufficiently serious that the drug products
should be removed from the market, and to enable withdrawal of approval
of their applications under Sec.  314.150(d).
    The anabolic steroid OXANDRIN (oxandrolone) tablets, 2.5 mg and 10
mg, under NDA 013718, is indicated as follows: ``as adjunctive therapy
to promote weight gain after weight loss following extensive surgery,
chronic infections, or severe trauma, and in some patients who without
definite pathophysiologic reasons fail to gain or to maintain normal
weight, to offset the protein catabolism associated with prolonged
administration of corticosteroids, and for the relief of the bone pain
frequently accompanying osteoporosis.'' \1\ FDA initially approved NDA
013718 in 1964.
---------------------------------------------------------------------------

    \1\ See OXANDRIN (oxandrolone) tablets, NDA 013718, product
labeling, (rev. June 2005), available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013718s023lbl.pdf.
---------------------------------------------------------------------------

    In January 1984, FDA's Endocrinologic and Metabolic Drugs Advisory
Committee met and discussed anabolic steroids. The advisory committee
unanimously concluded that there was no evidence of efficacy for
oxandrolone.\2\
---------------------------------------------------------------------------

    \2\ See minutes from the January 24 to 25, 1984, advisory
committee meeting discussing anabolic steroids, at pg. 7.
---------------------------------------------------------------------------

    As communicated in the product labeling, multiple safety warnings
and precautions are associated with the use of oxandrolone tablets
including peliosis hepatis, sometimes associated with liver failure and
intra-abdominal hemorrhage; liver cell tumors, sometimes fatal; and
blood lipid changes that are known to be associated with increased risk
of atherosclerosis.\3\ Per the labeling, additional warnings with using
this product include the risks associated with cholestatic hepatitis,
hypercalcemia in patients with breast cancer, and increased risk for
the development of prostatic hypertrophy and prostatic carcinoma in
geriatric patients.\4\
---------------------------------------------------------------------------

    \3\ See OXANDRIN (oxandrolone) tablets, NDA 013718, product
labeling, (rev. June 2005).
    \4\ Id.
---------------------------------------------------------------------------

    Based on FDA's review of currently available data and information
regarding the safety and effectiveness of oxandrolone tablets, the
Agency believes that the potential problems associated with oxandrolone
tablets are sufficiently serious that the drug should be removed from
the market.
    After FDA notified Gemini that it believes the potential problems
associated with the drug are sufficiently serious that the drug should
be removed from the market pursuant to Sec.  314.150(d), Gemini
requested in a letter dated December 19, 2022 that FDA withdraw
approval of NDA 013718 under Sec.  314.150(d). Gemini waived its
opportunity for a hearing. In a letter dated December 23, 2022, Sandoz
requested that FDA withdraw approval of ANDA 076897 under Sec.
314.150(d). Sandoz waived its opportunity for a hearing. In a letter
dated January 5, 2023, Par requested that FDA withdraw approval of ANDA
077827 under Sec.  314.150(d). Par waived its opportunity for a
hearing. In separate letters dated January 6, 2023, Upsher-Smith
requested that FDA withdraw approval of ANDAs 078033 and 076761 under
Sec.  314.150(d). Upsher-Smith waived its opportunity for a hearing.
    Therefore, for the reasons discussed above, which the applicants do
not dispute in their letters requesting withdrawal of approval under
Sec.  314.150(d), FDA's approval of NDA 013718 and ANDAs 076897,
077827, 078033, and 076761, and all amendments and supplements thereto,
are withdrawn (see DATES). Distribution of Gemini's OXANDRIN
(oxandrolone) tablets, 2.5 mg and 10 mg; Sandoz's oxandrolone tablets
2.5 mg and 10 mg; Par's oxandrolone tablets, 2.5 mg and 10 mg; or
Upsher-Smith's oxandrolone tablets, 2.5 mg and 10 mg, into interstate
commerce without an approved application is illegal and subject to
regulatory action (see sections 505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).

    Dated: June 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13733 Filed 6-27-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 23 (Thursday, February 3, 2011)]
[Proposed Rules]
[Pages 6111-6112]
[FR Doc No: 2011-2359]

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

SECURITIES AND EXCHANGE COMMISSION

17 CFR Parts 229 and 249

[Release No. 34-63795; File No. S7-42-10]
RIN 3235-AK85

Disclosure of Payments by Resource Extraction Issuers

AGENCY: Securities and Exchange Commission.

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Securities and Exchange Commission is extending the
comment period for a release proposing amendments to its rules pursuant
to Section 1504 of the Dodd-Frank Wall Street Reform and Consumer
Protection Act. [Release No. 34-63549; 75 FR 80977 (December 23,
2010)]. The original comment period for Release 34-63549 is scheduled
to end on January 31, 2011. The Commission is extending the time period
in which to provide the Commission with comments on that release for 30
days until Wednesday, March 2, 2011. This action will allow interested
persons additional time to analyze the issues and prepare their
comments.

DATES: Comments should be received on or before March 2, 2011.

ADDRESSES: Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/proposed.shtml);
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number S7-42-10 on the subject line; or
     Use the Federal eRulemaking Portal (http://www.regulations.gov). Follow the instructions for submitting comments.

Paper Comments

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

All submissions should refer to File Number S7-42-10. This file number
should be included on the subject line if e-mail is used. To help us
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/proposed.shtml). Comments
also are available for Web site viewing and

printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. All comments received will be posted without change; we
do not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly.

FOR FURTHER INFORMATION CONTACT: Tamara Brightwell, Senior Special
Counsel, Division of Corporation Finance, or Elliot Staffin, Special
Counsel in the Office of International Corporate Finance, Division of
Corporation Finance, at<PHONE_NUMBER>, U.S. Securities and Exchange
Commission, 100 F Street, NE., Washington, DC 20549.

SUPPLEMENTARY INFORMATION: The Commission has requested comment on a
release proposing amendments to its rules to implement Section 1504 of
the Dodd-Frank Wall Street Reform and Consumer Protection Act. Section
1504 added Section 13(q) to the Securities Exchange Act of 1934, which
requires the Commission to issue rules requiring resource extraction
issuers to include in an annual report information relating to any
payment made by the issuer, or by a subsidiary or another entity
controlled by the issuer, to a foreign government or the Federal
Government for the purpose of the commercial development of oil,
natural gas, or minerals. Section 13(q) requires a resource extraction
issuer to provide information about the type and total amount of
payments made for each project related to the commercial development of
oil, natural gas, or minerals, and the type and total amount of
payments made to each government. In addition, Section 13(q) requires a
resource extraction issuer to provide certain information regarding
those payments in an interactive data format, as specified by the
Commission. This release was published in the Federal Register on
December 23, 2010.
    The Commission originally requested that comments on the release be
received by January 31, 2011. The nature of the proposed disclosure
requirements differs from the disclosure traditionally required by the
Exchange Act, and the proposal requested comment on a variety of
significant aspects of the proposed rules. The Commission has received
requests for an extension of time for public comment on the proposal
to, among other things, allow for the collection of information and to
improve the quality of responses.\1\ The Commission believes that
providing the public additional time to consider thoroughly the matters
addressed by the release and to submit comprehensive responses to the
release would benefit the Commission in its consideration of final
rules. Therefore, the Commission is extending the comment period for
Release No. 34-63549 ``Disclosure of Payments by Resource Extraction
Issuers'' for 30 days, to Wednesday, March 2, 2011.
---------------------------------------------------------------------------

    \1\ See, e.g., letters from National Mining Association (January
3, 2011); National Stone, Sand & Gravel Association (January 13,
2011); and World Gold Council (January 7, 2011). Comments are
available on the Commission's Internet Web site at http://www.sec.gov/comments/s7-42-10/s74210.shtml.

---------------------------------------------------------------------------
    By the Commission.

    Dated: January 28, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-2359 Filed 2-2-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Page 71527]
[FR Doc No: 2019-27900]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0191]

Agency Information Collection Activities; Renewal of a Currently-
Approved Information Collection Request: Financial Responsibility for
Motor Carriers of Passengers and Motor Carriers of Property

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

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. The information
collected will be used to help ensure that motor carriers of passengers
and property maintain appropriate levels of financial responsibility.

DATES:  We must receive your comments on or before January 27, 2020.

ADDRESSES: All comments should reference Federal Docket Management
System (FDMS) Docket Number FMCSA-2019-0191. Interested persons are
invited to submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the attention
of the Desk Officer, Department of Transportation/Federal Motor Carrier
Safety Administration, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503. In the 60-day Federal Register notice (84 FR 52164) published
on October 1, 2019, FMCSA received two comments. One was from an
anonymous commenter which was not relevant to the information
collection. The National School Transportation Association submitted a
letter supporting the Agency's proposal to renew the information
collection.

FOR FURTHER INFORMATION CONTACT: Mr. Jeff Secrist, Office of
Registration and Safety Information, Chief, Registration, Licensing and
Insurance Division, Department of Transportation, Federal Motor Carrier
Safety Administration, West Building 6th Floor, 1200 New Jersey Avenue
SE, Washington, DC 20590. Telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Office hours are from 9 a.m. to 5 p.m., Monday
through Friday, except Federal Holidays.

SUPPLEMENTARY INFORMATION:
    Title: Financial Responsibility for Motor Carriers of Passengers
and Motor Carriers of Property.
    OMB Control Number: 2126-0008.
    Type of Request: Renewal of a currently-approved information
collection.
    Respondents: Insurance underwriters for insurance and surety
companies of motor carriers of property (Forms MCS-90 and MCS-82) and
passengers (Forms MCS-90B and MCS-82B), motor carrier clerks employed
by motor carriers (storing/maintaining insurance and/or surety bond
documentation), and vehicle maintenance staff employed by Canadian and
Mexican/non-North-American (NNA) domiciled motor carriers (placing
copies of documentation in vehicles).
    Estimated Number of Respondents: 202,458.
    Estimated Time per Response: FMCSA estimates it takes 2 minutes to
complete the Endorsement for Motor Carrier Policies of Insurances for
Public Liability (Forms MCS-90 for property carriers and MCS-90B for
passenger carriers) or the Motor Carrier Public Liability Surety Bond
(Forms MCS-82 for property carriers and MCS-82B for passenger
carriers); 1 minute to store/maintain documents at the motor carrier's
place of business [49 CFR 387.7(d); 49 CFR 387.31(d)]; and 1 minute to
place either document on board the vehicle, required for Canadian and
Mexican/NNA carriers operating in the United States [49 CFR 387.7(f);
387.31(f)].
    Expiration Date: January 31, 2020.
    Frequency of Response: Upon creation, change, or replacement of an
insurance policy or surety bond.
    Estimated Total Annual Burden: 5,739 hours [4,931 annual burden
hours for ICs 1-4 + 808 annual burden hours for IC-5 document placement
in vehicles = 5,739].
    Background: The Secretary of Transportation is responsible for
implementing regulations which establish minimal levels of financial
responsibility for: (1) For-hire motor carriers of property to cover
public liability, property damage and environmental restoration, and
(2) for-hire motor carriers of passengers to cover public liability and
property damage. The Endorsement for Motor Carrier Policies of
Insurance for Public Liability (Forms MCS-90/90B) and the Motor Carrier
Public Liability Surety Bond (Forms MCS-82/82B) contain the minimum
amount of information necessary to document that a motor carrier of
property or passengers has obtained, and has in effect, the minimum
levels of financial responsibility as set forth in applicable
regulations (motor carriers of property--49 CFR 387.9; and motor
carriers of passengers--49 CFR 387.33). FMCSA and the public can verify
that a motor carrier of property or passengers has obtained, and has in
effect, the required minimum levels of financial responsibility, by use
of the information enclosed within these documents.
    The 60-day Federal Register notice (84 FR 52164) published on
October 1, 2019, announced FMCSA's intent to submit the Financial
Responsibility of Motor Carriers of Passengers and Motor Carriers of
Property clearance process to OMB for approval and requested comments
from the public for 60 days. The FMCSA received two comments in
response to the 60-day Federal Register notice. One was from an
anonymous commenter which was not relevant to the information
collection. The National School Transportation Association submitted a
letter supporting the Agency's proposal to renew the information
collection.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the FMCSA to perform its functions; (2) the
accuracy of the estimated burden; (3) ways for the FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information.

    Issued under the authority delegated in 49 CFR 1.87 on December
19, 2019.
Kelly Regal,
Associate Administrator for Office of Research and Information
Technology.
[FR Doc. 2019-27900 Filed 12-26-19; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Rules and Regulations]
[Pages 2437-2441]
[FR Doc No: 2019-01244]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0015; Product Identifier 2018-NM-179-AD; Amendment
39-19550; AD 2019-02-03]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model 787-8, 787-9, and 787-10 airplanes. This AD
requires revising the existing maintenance or inspection program, as
applicable, to

incorporate new or more restrictive airworthiness limitations. This AD
was prompted by reports of warpage of internal engine fire handle
components, which can cause binding and prevent proper operation. We
are issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective February 22, 2019.
    We must receive comments on this AD by March 25, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0015; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The street address for Docket Operations (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Rebel Nichols, Aerospace Engineer,
Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We have received reports from Boeing of warpage of internal engine
fire handle components, which can cause binding and prevent proper
operation. A latently failed engine fire handle could prevent the fire
extinguishing agent from being able to be released. In the event of
certain engine fires, the potential exists for an engine fire to be
uncontrollable. This unsafe condition, if not addressed, could result
in the inability to extinguish an engine fire that, if uncontrollable,
could lead to wing failure.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires revising the existing maintenance or inspection
program, as applicable, to incorporate new or more restrictive
airworthiness limitations.
    Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this AD, the operator may not be able to
accomplish the actions described in the revisions. In this situation,
to comply with 14 CFR 91.403(c), the operator must request approval for
an alternative method of compliance according to paragraph (j) of this
AD.

Interim Action

    We consider this AD interim action. The manufacturer is currently
developing a terminating action that will address the unsafe condition
identified in this AD. Once this terminating action is developed,
approved, and available, we might consider additional rulemaking.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule
because warpage of internal engine fire handle components can cause
binding and prevent proper operation. A latently failed engine fire
handle could prevent the fire extinguishing agent from being able to be
released. In the event of certain engine fires, the potential exists
for an engine fire to be uncontrollable, which could lead to wing
failure. Additionally, the compliance time for the required action is
shorter than the time necessary for the public to comment and for
publication of the final rule. Therefore, we find good cause that
notice and opportunity for prior public comment are impracticable. In
addition, for the reasons stated above, we find that good cause exists
for making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this final rule. Send your comments to an address
listed under the ADDRESSES section. Include the docket number FAA-2019-
0015 and Product Identifier 2018-NM-179-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this final rule. We will
consider all comments received by the closing date and may amend this
final rule because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this final rule.

Costs of Compliance

    We estimate that this AD affects 120 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:
    We have determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although we recognize that this number may vary from operator to
operator. In the past, we have estimated that this action takes 1 work-
hour per airplane. Since operators incorporate maintenance or
inspection program changes for their affected fleet(s), we have
determined that a per-operator estimate is more accurate than a per-
airplane estimate. Therefore, we estimate the total cost per operator
to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation Programs''
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation

is within the scope of that authority because it addresses an unsafe
condition that is likely to exist or develop on products identified in
this rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2019-02-03 The Boeing Company: Amendment 39-19550; Docket No. FAA-
2019-0015; Product Identifier 2018-NM-179-AD.

(a) Effective Date

    This AD is effective February 22, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 787-8, 787-9,
and 787-10 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
protection.

(e) Unsafe Condition

    This AD was prompted by reports of warpage of internal fire
handle components, which can cause binding and prevent proper
operation. We are issuing this AD to address a latent failure of the
engine fire handle, which could result in the inability to
extinguish an engine fire that, if uncontrollable, could lead to
wing failure.

(f) Compliance

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

(g) Revision of Maintenance or Inspection Program

    Within 14 days after the effective date of this AD, revise the
existing maintenance or inspection program, as applicable, to add
airworthiness limitation 28-AWL-FIRE, by incorporating the
information specified in figure 1 to paragraph (g) of this AD into
the Airworthiness Limitations Section of the Instructions for
Continued Airworthiness. The initial compliance time for
accomplishing the actions specified in figure 1 to paragraph (g) of
this AD is within 45 days after the effective date of this AD.
[GRAPHIC] [TIFF OMITTED] TR07FE19.000

[GRAPHIC] [TIFF OMITTED] TR07FE19.001

(h) No Alternative Actions or Intervals

    After accomplishment of the existing maintenance or inspection
program revision required by paragraph (g) of this AD, no
alternative actions (e.g., inspections) or intervals may be used
unless the actions or intervals are approved as an alternative
method of compliance (AMOC) in accordance with the procedures
specified in paragraph (j) of this AD.

(i) Special Flight Permit

    Special flight permits, as described in 14 CFR 21.197 and
21.199, are not allowed.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (k) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO Branch, FAA, to make those findings. To be
approved, the repair method, modification deviation, or alteration
deviation must meet the certification basis of the airplane, and the
approval must specifically refer to this AD.

(k) Related Information

    For more information about this AD, contact Rebel Nichols,
Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch,
2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-
3556; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    None.

    Issued in Des Moines, Washington, on January 30, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-01244 Filed 2-6-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 16 (Friday, January 24, 2014)]
[Notices]
[Pages 4186-4188]
[FR Doc No: 2014-01398]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71344; File No. SR-BOX-2014-02]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Filing of Proposed Rule Change To Amend BOX Rule 8130

January 17, 2014.
    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 January 6, 2014, BOX Options Exchange LLC (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 the self-regulatory organization. The Commission
is publishing this notice to solicit comments on the proposed rule from
interested persons.
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    \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 BOX Rule 8130 (Automatic Quote
Cancellation) to require Market Makers to enter values in at least one
of the Exchange-provided risk parameters. The text of the proposed rule
change is available from the principal office of the Exchange, at the
Commission's Public Reference Room and also on the Exchange's Internet
Web site at http://boxexchange.com.

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

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

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

1. Purpose
    The Exchange proposes to amend BOX Rule 8130 (Automatic Quote
Cancellation) to require Market Makers \3\ to enter values in at least
one of the Exchange-provided risk parameters. This is a competitive
filing based on a proposal recently submitted by the International
Securities Exchange, LLC (``ISE'') and approved by the Commission.\4\
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    \3\ As defined in BOX Rule 100 (a)(30), the term ``Market
Maker'' means an Options Participant registered with the Exchange
for the purpose of making markets in options contracts traded on the
Exchange and that is vested with the rights and responsibilities
specified in the Rule 8000 Series. All Market Makers are designated
as specialists on the Exchange for all purposes under the Exchange
Act or Rules thereunder.
    \4\ See Securities Exchange Act Release No. 70132 (August 7,
2013), 78 FR 49311 (August 13, 2013) (Order Approving SR-ISE-2013-
38).
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    BOX Rule 8040 (Obligations of Market Makers) requires Market Makers
to enter and maintain continuous quotations for the options classes to
which they are appointed. This requirement creates a possibility of
``rapid fire'' executions that could result in large and unintended
principal positions and expose the Market Maker to unnecessary market
risk. To lessen this risk, many

Market Makers employ their own proprietary quotation and risk
management systems to determine the prices and sizes at which they
quote. Additionally, under the current BOX Rule 8130 the Exchange
offers Market Makers the ability to automatically cancel quotes in
specified classes if certain triggering parameters are met.\5\ When
enabled, these triggering parameters can help Market Makers manage
their risk and protect them from a ``rapid fire'' execution scenario.
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    \5\ See Securities Exchange Act Release No. 55472 (March 14,
2007), 72 FR 13322 (March 21, 2007) (Notice of Filing and Immediate
Effectiveness of SR-BSE-2007-08).
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    Specifically, under BOX Rule 8130 there are five triggering
parameters that Market Makers can enable on a class-by-class basis.
These are when the Market Maker: (1) Experiences a duration of no
technical connectivity for between one and nine seconds; (2) trades a
specified number of contracts in the aggregate across all series of an
options class; (3) trades a specified absolute dollar value of
contracts bought and sold in a class; (4) trades a specified number of
contracts in a class of the net between (i) calls purchased plus puts
sold, and (ii) calls sold and puts purchased; or, (5) trades a
specified absolute dollar value of the net position in a class between
(i) calls purchased and sold, (ii) puts and calls purchased; (iii) puts
purchased and sold; or (iv) puts and calls sold.
    The risk to Market Makers is not limited to a single option series.
Market Makers have exposure in all series of a particular options class
in which they are appointed, requiring them to offset or hedge their
overall position in each option to minimize risk. By limiting a Market
Maker's exposure across series, the Exchange believes that a Market
Maker is able to provide quotations at better prices. The Exchange
believes that the Exchange-provided risk parameters help Market Makers,
as key liquidity providers, to better manage their risk, aiding them in
providing deeper and more liquid markets, beneficial to all
Participants.
    Under Rule 8130, Market Makers are currently not required to use
the Exchange-provided risk parameters and can program their own systems
to perform similar functions if they prefer. The Exchange proposes to
amend Rule 8130 to prevent Market Makers from inadvertently entering
quotes without any internal or external risk-management parameters.
Specifically, the Exchange proposes to make it mandatory for a Market
Maker to enter values in at least one triggering parameter for each of
their appointed options classes. The Exchange is not proposing to
require values be entered for all five triggering parameters, as the
Exchange is aware that Market Makers have different internal risk
control mechanisms and therefore will use the tool differently.
Additionally, Market Makers that currently use this feature have
elected to use different parameters based on their specific needs.
    While entering values into at least one of the risk parameters will
now be mandatory to prevent an inadvertent exposure to risk, Market
Makers who prefer to use their own risk-management systems can enter
values that will ensure the Exchange-provided parameters will not be
triggered.\6\ Accordingly, the proposal does not require members to
manage their risk using the Exchange-provided tools.
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    \6\ For example, a Market Maker could set the value for the
total number of contracts in the aggregate across all series of an
options class at a level that exceeds the total aggregate number of
contracts that the Market Maker actually quotes in all the series of
the option class.
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    The Exchanges notes that nothing under this proposed rule change
relieves a Market Maker of its obligations to provide continuous, two
sided quotes under Rule 8050.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Securities Exchange Act of 1934
(the ``Act''),\7\ in general, and Section 6(b)(5) of the Act,\8\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general to protect investors and the
public interest.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that requiring Market Makers to enter values
for at least one of the triggering parameters will not be unreasonably
burdensome, as Market Makers who prefer to use their own risk-
management systems can enter out-of-range values so that the Exchange-
provided parameters will not be triggered. Moreover, the Exchange is
proposing this rule change in order to reduce the risk of a Market
Marker inadvertently entering quotes without populating any of the
triggering parameters. Reducing such risk will enable Market Makers to
enter quotations with larger size, which in turn will benefit investors
through increased liquidity for the execution of their orders. Such
increased liquidity benefits investors because they receive better
prices and because it lowers volatility in the options market.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In this regard and as indicated
above, the Exchange notes that the proposed rule change is
substantially similar to a filing submitted by ISE that was recently
approved by the Commission.\9\ The proposal is meant to help Market
Makers manage risk by preventing the inadvertent entry of quotes
without any risk-management parameters, whether internal or external.
As noted above, Market Makers who prefer to use their own risk-
management systems can enter out-of-range values so that the Exchange-
provided parameters will not be triggered. Accordingly, the proposal
does not require members to manage their risk using this feature.
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    \9\ See supra, note 4.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

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

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)(ii) of the Act \10\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \11\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change along with a
brief description and the 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.
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    A proposed rule change filed under Rule 19b-4(f)(6) \12\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to

Rule 19b-4(f)(6)(iii) \13\ the Commission may designate a shorter time
if such action is consistent with the protection of investors and the
public interest. The Exchange requested that the Commission waive the
30-day operative delay. The Exchange stated that waiver of the
operative delay will allow the Exchange to quickly adopt an additional
risk protection feature for Market Makers.
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    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
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    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest,
because the Exchange will be able to implement promptly an amended
automatic quote cancellation feature that will require a Market Maker
to enter values for at least one of the triggering parameters, and thus
the proposal may help Market Makers mitigate their quoting risk
exposure.\14\
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    \14\ As noted by the Exchange above, Market Makers who prefer to
use their own risk-management systems can enter out-of-range values
so that the Exchange-provided parameters will not be triggered.
Thus, the proposal does not require members to manage their risk
using the Exchange's automatic quote cancellation feature.
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    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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BOX-2014-02 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-BOX-2014-02. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BOX-2014-02 and should be
submitted on or before February 14, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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 Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-01398 Filed 1-23-14; 8:45 am]
BILLING CODE 8011-01-P