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(~) I: q~.~ o~ c~ ° PROGRAM REVIEW REPORT ON THE ENFORCEABLE CONSENT AGREEMENT FOR 1,1,2 TRICHLOROETHANE CAS No. 79 00 5 e Docket No. OPPT 2002 005 6 DATE April 21, 2003 U. S. E. P. A.

Office of Pollution Prevention and Toxics Office of Research and Development OPPT 2002 0056 0059 RECEIVED OPPT NCIC 2003 JUN23 9: 50AM Program Review Report on the Enforceable Consent Agreement for 1,1,2 Trichioroethane TABLE OF CONTENTS Page I. Introduction 1 II. Description of the TCE Alternative Testing Program 3 III. EPA Program Review Approach 4 IV. Program Review Findings 5 V. Conclusions and Recommendations 10 VI. References 11 VII. List of Contributors 13 Appendix 1: ECA Required Testing, Test Standards, Reporting and Other Requirements for 1,1 ,2 Trichloroethane 14   1   I. INTRODUCTION 1,1 ,2 Trichloroethane ( TCE)( CAS No. 79 00 05) is used as a feedstock intermediate in the production of vinylidene chloride and some tetrachioroethanes. It is also used as a solvent where its high solvency for chlorinated rubbers and other substances is needed, and for pharmaceuticals and electronic components. TCE was listed as a hazardous air pollutant ( HAP) under revisions to the Clean Air Act of 1990 ( 42 U. S. C. 7413).

On June 26, 1997, the Environmental Protection Agency ( EPA) proposed a test rule for 21 HAP chemicals including TCE ( 61 FR 33178; 62 FR 67466; 63 FR 5915; and 63 FR 19694). 1 While the rulemaking proposed that all testing be conducted by the inhalation route of exposure, it also invited the submission of alternative testing proposals supporting the development of physiologically based pharmacokinetic ( PBPK) computational models for route to route extrapolation ofdose response to predict response for inhalation exposure. Computational dosimetry models could take advantage of studies ( acceptable to EPA) that were conducted by routes other than inhalation and allow for route to route extrapolation of dose response to inhalation exposure scenarios. Alternative testing proposals that incorporate PBPK dosimetry modeling, if acceptable to EPA, could provide the basis to develop a tailored approach to inhalation testing proposed in the HAP rulemaking via the enforceable consent agreement ( ECA) process ( 40 CFR 790.22( b)).

On November 22, 1996, the Hazardous Air Pollutant Task Force ( HAP Task Force) 2 submitted an alternative testing proposal for TCE ( HAP Task Force 1996). EPA evaluated this proposal and determined that it formed a sufficient basis to initiate ECA discussions to develop an ECA for TCE ( U. S. EPA 1997). Discussions to develop an ECA for TCE were initiated at a public meeting on January 12, 1998 ( 62 FR 66628; December 19, 1997). These discussions led to the development of a successful ECA and, under the authority ofsection 4 ofthe Toxic 1 The official record for the proposed HAP rulemaking, including the public version, is established under EPA docket control number OPPTS  42198B. The EPA Docket Center is located in Room B 102 Reading Room, EPA West, 1301 Constitution Avenue, N. W., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays.

2 Member companies of the HAP Task Force include: The Dow Chemical Company, Vulcan Materials Company, Occidental Chemical Corporation, Oxy Vinyls, LP, CONDEA Vista Company, Georgia Gulf Corporation, Westlake Chemical Corporation, PPG Industries, Inc., and Formosa Plastics Corporation, U. S. A. The Borden Chemicals & Plastics Operating Limited Partnership is undergoing Chapter 11 and has withdrawn from the HAP Task Force.

1 Substances Control Act ( TSCA) ( 15 U. S. C. 2603), EPA and member Companies ofthe HAP Task Force entered into an ECA to conduct testing for TCE ( 65 FR 37550).~

EPA announced the receipt oftest results for testing conducted under the Tier I and Tier I Program Review segments ofthe ECA for TCE ( 67 FR 17429, April 10, 2002; 67 FR 17996, April 12, 2002; and 67 FR 53001, August 14, 2002). Specifically, EPA announced receipt of four reports entitled:

1. " Acute Inhalation Toxicity ( with Histopathology) Study of 1,1 ,2 Trichloroethane ( 1, l, 2 TCE) in Rats by V/ IL Research Laboratories, Inc." ( 67 FR 17429, April 10, 2002),

2. " Pharmacokinetics of 1,1 ,2 Trichloroethane in Rats and Mice by Battelle Pacific Northwest Laboratories." ( 67 FR 17996, April 12, 2002).

3. " A 90 Day Inhalation Toxicity Study of 1,1 ,2 Trichloroethane ( 1,1,2 TCE) in Rats ( With Satellite Groups for Pharmacokinetic Evaluations in Rats and Mice)" ( 67 FR 53001, August 14, 2002),

4, " Physiologically Based Pharmacokinetic Model Development, Simulations, and Sensitivity Analysis for Repeated Exposure to 1,1 ,2 Trichloroethane" ( 67 FR 53001, August 14, 2002).

On October 16, 2002, EPA announced the initiation of a program review to evaluate data received under the Tier I Program Review Testing segment ofthe ECA for TCE ( 67 FR 639 13).~ This announcement solicited public comment on the Tier I Program Review testing reports submitted by the HAP Task Force ( see above # 2 and # 4) and asked whether or not it is feasible and appropriate to apply this data and other studies acceptable to EPA to inform the TCE model ~ The official record for developing the ECA alternative testing program for TCE, including the public version, is established under EPA docket control number OPPTS 42198B, while the official record for data developed under this ECA, including the public version, is established under EPA docket control number OPPTS 42198C. The EPA Docket Center is located in Room B 102 Reading Room, EPA West, 1301 Constitution Avenue, N. W., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays.

~ The official record for this action is established under EPA e Docket OPPT 2002 0056. The EPA Docket Center is located in Room B 102 Reading Room, EPA West, 1301 Constitution Avenue, N. W., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. An electronic version ofthis public docket is available through EPA's electronic public docket system, EPA Dockets at http:// www. epa. govfedocket/. Once in the system, select " search," then key in OPPT 2002 0056.

2 for quantitative computational route to route dosimetry extrapolations of endpoints listed under the Tier II testing segment of the ECA for TCE. Comments received from this announcement would be used to inform EPA's Program Review. In conjunction with this announcement, EPA's Office of Prevention, Pollution and Toxics ( OPPT), Chemical Control Division ( CCD) requested that EPA's Office of Research and Development's ( ORD), National Center for Environmental Assessment ( NCEA) review the TCE ECA Tier I Program Review model development and related pharmacokinetics and mechanistic ( PKIMECH) data to determine if these materials are sufficient to advance the ECA testing to the Tier II segment ofthe ECA for TCE.

The findings and conclusions for the EPA Program Review activity are described in this report. This report, along with a copy of the letter sent to the HAP Task Force informing it of EPA's Program Review conclusions, and comments received from the October 16, 2002 Federal Register announcement will be placed in the record for this action. 4 II. DESCRIPTION OF THE TCE ALTERNATIVE TESTING PROGRAM The alternative testing program approach to address dataneeds for TCE identified in the HAP rulemaking includes new testing by both the inhalation and oral routes ofexposure, development of PK/ MECH data directed at characterizing the mode of action ofTCE, development of a computational dosimetry model based upon the PK/ MECH data to support quantitative route to route extrapolation from acceptable extant studies and studies conducted under the TCE alternative testing program, and extrapolations for route and species differences from acceptable extant studies in the literature for TCE and new testing conducted under the ECA. There are four segments to the alternative testing program for TCE: 1) Tier I HAPs Testing; 2) Tier I Program Review Testing; 3) EPA Program Review; and 4) Tier II Testing and/ or Extrapolation Reporting. Testing under these segments is summarized in Table 1 of the ECA for TCE ( see Appendix 1 of this report).

The Tier I HAP Testing included endpoint testing for acute and subchronic toxicity by inhalation exposure. EPA determined that the existing cytogenicity studies conducted by Mazzulo et a!. ( 1986) and Doherty et al. ( 1996) were adequate to characterize the mutagenicity~ of TCE.

The Tier I Program Review Testing included: ( 1) development ofa computational dosimetry model specific for TCE in rats and mice, ( 2) simulation testing of the predictive capability ofthe model against an inhalation test data set, and ( 3) demonstration ofthe model's utility in supporting quantitative route to route dosimetry extrapolations. In addition, the HAP Task Force conducted studies generating PKIMECH data needed to develop the model for the endpoints listed in Tier II ofthe ECA for TCE. Specifically, the model and the PKIMECH data developed under the Tier I Program Review Testing are used to: ( 1) simulate the dose response curve that would result from an inhalation exposure based upon the results observed in existing 3 immunotoxicity data in mice administered TCE via drinking water ( Sanders et al., 1985), ( 2) simulate the dose response from an inhalation exposure based upon the results observed in existing mouse cancer bioassay data in mice administered TCE via corn oil gavage ( NCI, 1978), and ( 3) demonstrate the overall utility ofthe PBPK model for route to route ( oral to inhalation) dose response extrapolation for other endpoints based upon oral exposure studies ( to be conducted in Tier II) including: ( a) neurotoxicity based on an oral drinking water study in rats, ( b) developmental toxicity based on oral drinking water exposure in rats and mice, and ( c) reproductive effects toxicity based on oral drinking water exposure in rats.

The Program Review segment was included in the ECA for TCE as a mechanism to address uncertainty regarding model structure and the impact of new insights identified from the Tier I and Tier I Program Review testing on the model structure and Tier II route to route dosimetry extrapolations. Since modeling is an iterative process the Program Review provides opportunity for the EPA and the HAP Task Force to incorporate additional changes, if necessary, into the model development and/ or the Tier II testing and route to route dosimetry extrapolation reporting.

The Tier II Testing and Extrapolation Reporting segment of the ECA for TCE will include: acute neurotoxicity, subchronic neurotoxicity, developmental toxicity, and reproductive effects toxicity testing by the oral route of exposure, and computational route to route doseresponse extrapolation for acute neurotoxicity, subchronic neurotoxicity, developmental toxicity, reproductive effects toxicity, immunotoxicity, and carcinogenicity.

III. EPA PROGRAM REVIEW APPROACH As stated in the ECA for TCE, the purpose of the Program Review is to determine: ( 1) if the submitted toxicity and PKIMECH data, the PBPK model, and the reports submitted by the HAP Task Force ( see above Section I) are per the specifications defined in Part VI including Table 1 and the accompanying Appendices ofthe ECA for TCE; ( 2) whether it is feasible and appropriate to apply Tier I Program Review Testing data and data from other studies acceptable to EPA to inform route to route dosimetry extrapolations for endpoints listed in the Tier II Testing segment; ( 3) whether the data from the Tier I Program Review Testing segment ( see Part VI. B. ofthe ECA for TCE) provide a sufficient basis for conducting the endpoint testing and/ or the route to route dosimetry extrapolations specified in the Tier II Testing segment ofthe ECA for TCE; and/ or ( 4) the nature and scope of any additional work that may be required prior to the commencement of Tier II Testing and extrapolation reporting ( e. g., additional PKIMECH data as described in Part VII. ofthe ECA for TCE).

EPA's ORD/ NCEA conducted a comprehensive review of the data and reports submitted to the Agency under the Tier I HAPs Testing and the Tier I Program Review Testing. The initial step included checking the toxicity and PK! MECH data, the PBPK model, and the reports for 4 quality and completeness of the information in accordance with the specifications established under Part VI and including Table 1 and the accompanying Appendices of the ECA for TCE. EPA then assessed how well the PK/ MECH data characterized the mode ofaction and supported the biological plausibility of the HAP Task Force PBPK model for TCE. In addition, EPA assessed the quality and predictive capability ofthe TCE PBPK model for simulating a doseresponse from an inhalation exposure based upon oral exposure data. The criteria for this component ofthe EPA review was based on accepted practice described in the scientific literature and outlined in Part V ofthe ECA for TCE. This aspect of the model evaluation also included consideration ofthe inhalation and oral exposure data generated in the Tier I and Tier I Program Review segments of the alternative testing program for TCE and how well the TCE PBPK model performed in simulating the calibration and test data sets provided by the HAP Task Force. EPA then considered the utility ofthe TCE PBPK model for extrapolating doseresponse curves from oral to inhalation exposures based only upon existing oral exposure data ( or oral exposure data to be generated in Tier II) for the following data needs  neurotoxicity, developmental toxicity, and reproductive effects toxicity in the F344 rat; and developmental toxicity, immunotoxicity, and carcinogenicity in the mouse. Finally, based on new findings from the Tier I and Tier I Program Review Testing, the EPA review identified the nature and scope of additional considerations to be addressed in the Tier II protocol development and route to route extrapolation reporting.

Specifically, EPA conducted a five step evaluation of the TCE PBPK model that addressed: 1) model purpose, 2) model structure and biological plausibility, 3) mathematical representation and computer implementation, 4) model calibration ( data used and derivation of parameter values, data support for parameter values, sensitivity analysis, optimization), and 5) predictive utility ofthe model for TCE.

IV. PROGRAM REVIEW FINDINGS A. COMPLETENESS OF REPORTED INFORMATION EPA's review of the Tier I Program Review PKJMECH data and Tier I toxicity studies indicate that they were conducted in accordance with the protocols and specifications ofthe ECA. The available study records are sufficient to allow an evaluation of the quality of the data and reports. The TCE PBPK model is chemical specific and based on an understanding from the data for the kinetics and mode of action ofthe various endpoint toxicities for TCE for which there are data. The species, dose level, exposure regimens, and vehicles used were as specified in the ECA for Tier I and Tier I Program Review Testing.

5 B. APPLICATION OF TIER I TEST RESULTS TO ROUTE TO ROUTE EXTRAPOLATION The rat PBPK model is parameterized to fit the blood concentration time course for the rat kinetic data from exposures via inhalation ( 100 ppm), gavage oil ( 94 mg/ kg/ day), and gavage water ( 1.66 mg/ kg/ day). Metabolic parameters ( Vmax and Km) were optimized for the inhalation data. The absorption rates for the oil and water vehicles were optimized to fit the respective gavage data. The resulting model was then used to simulate all data sets without further changes in the parameter values.

The mouse PBPK model is parameterized to fit the blood concentration time course for the mouse kinetic data from exposures via inhalation, gavage oil, and gavage water. Vmax was optimized for the oil gavage data, and terms were added to the model to simulate a proposed suicide inhibition ofenzyme from binding to a reactive intermediate that occurs only in females. Absorption rates for the oil and water vehicles were optimized to fit the respective gavage data. The resulting model was then used to simulate the inhalation data without further changes in the parameter values.

The Tier I Program Review PKIMECH data demonstrated that periodicity was achieved for the studies that supported the model development. Periodicity, as defined in U. S. EPA ( 1994), is achieved when the internal concentration ofthe dose metric of interest ( e. g., parent venous concentration) versus time profile is the same for 90% of the exposure period.

The PBPK model simulations are within a factor of 2 fold ( on average) ofthe fitted data as specified under the ECA, except for the fits to the corn oil gavage dose in rats. EPA notes that further optimization of the parameter values for absorption or maximum metabolic rate ( Vmaxc) would likely improve the fit. Since the sensitivity ofthe model output to the value for the maximum metabolic rate depends upon the dose levels specified in the Tier II study protocols ( i. e., depends upon the levels of parent compound achieved in the tissue relative to Km), EPA considers further adjustments to parameter values to improve fit should be an important consideration for the HAP Task Force to address in developing Tier II protocols C. BASIS FOR CONDUCTING THE ENDPOINT TESTING AND/ OR THE ROUTE TO ROUTE DOSIMETRY EXTRAPOLATIONS IN TIER II The Tier I Testing Program results support the use of the PBPK model for route to route dosimetry extrapolations for the extant and proposed Tier II studies. Periodicity was demonstrated. Although effects on nasal epithelial tissues were noted in Tier I inhalation testing, these changes were not deemed to significantly impact the systemic distribution ofthe parent compound, and first pass effects can be accounted for in the HAP Task Force PBPK model for TCE. The structure ofthe PBPK model for TCE supports simulations for a variety of internal dose metrics allowing choice for the dose metric that will be most relevant to the endpoints 6 identified for Tier II. This PBPK model for TCE includes simulation of the carcinogenicity and immunotoxicity dose response data from existing studies, and for the developmental, reproductive effects, and neurotoxicity dose response data to be developed in the Tier II testing.

At the time when the ECA for TCE was developed, EPA and the HAP Task Force specified whether the parent compound or measures of metabolite production should be used for the route dosimetry extrapolations for each ofthe Tier II endpoints. These specifications were based on the best available understanding for the mode ofaction for TCE at that time. Since then, the Tier I testing developed new information regarding potential portal ofentry effects and a proposed mechanism of suicide inhibition. EPA believes that considerations for these new data must be incorporated into Tier II Testing because the most appropriate internal measure of dose is ultimately determined by mode of action data or dose response data allowing evaluation ofthe degree ofcorrelation ofthe dose metric and the response. In the absence of adequate information, alternative dose metrics should be evaluated for the Tier II route to route dosimetry extrapolations. For risk assessment purposes, EPA intends to select the extrapolation which EPA considers to be most conservative ( i. e., the most health protective).

For TCE, the dose metrics for the parent compound include the maximum concentration ( Cmax) and the area under the curve ( AUC) for venous blood, spleen, or brain. Both Cmax and AUC in blood will be calculated for the developmental, reproductive effects, and neurotoxicity studies. Cmax and AUC will be calculated in spleen for the immunotoxicity study, ( as indicated in Appendix C. 2 of the ECA for TCE), and in blood and brain for the neurotoxicity studies ( as indicated in Table 1  Tier II Testing and/ or Extrapolation Reporting of the ECA for TCE). The route dosimetry extrapolations to inhalation will be conducted using both dose metrics. To the extent that additional information on the mode of action or correlations with response is available to support one dose metric over the other, this information will be available in the Tier II reporting consistent with Appendix C. 5 point 3.0 ( which indicates dose measure will be determined by Tier II testing). In the absence of a toxic response for the endpoint of concern, there is no need to calculate dose metrics or conduct the route dosimetry extrapolation. Should mode ofaction data be available to support a dose metric other than Cmax orAUC for parent compound ( e. g. time above a critical concentration as is sometimes used in phannaceutical applications) that dose metric will be derived and added to the overall evaluation.

The dose metric for metabolite will be the amount metabolized per day normalized to liver weight. A gender difference in metabolic time concentration profiles has been observed in mice that will affect the route dosimetry extrapolations based upon the extant mouse data for carcinogencity. The time concentration profile data for female mice from the oil gavage studies conducted in Tier I, and a previously observed reduction in aniline hydroxylase in female mice only ( White et al., 1985) support a mechanism of suicide inhibition of enzyme by TCE in female mice, but not males. In the case of no difference in dose response between males and females, the Agency will favor the more health protective route extrapolation based upon the female kinetic data ( i. e., the presence ofsuicide inhibition) for the dose response analyses.

7 Table 1 of the ECA indicates that metabolite in blood will be evaluated for the Tier II acute neurotoxicity study. Given the Tier I study results and the reactive nature ofthe metabolites formed, metabolite in blood is not a reasonable dose metric for neurotoxicity. Appropriately, the HAP Task Force did not include this in the pharmacokinetic model developed in Tier 1. However, EPAbelieves that it is plausible that damage caused by reactive metabolites could impact dosimetry extrapolations for both the neurotoxicity and immunotoxicity endpoints ( although narcotic effects would be expected to arise from the parent compound). Ideally this should be assessed by estimating the formation of reactive metabolites in potential target tissue ( e. g. CNS, spleen). Based upon current understanding of cytochrome p450 ( CYP2E1) activity, EPA anticipates that there will be substantial uncertainty in estimating the extent of metabolism in such target tissues. Target tissue specific metabolism could simply be modeled as a low fraction of liver activity ( e. g. 0.1% is suggested for brain by Tinberg and Ingelman Sundberg, 1996) for these Tier II route dosimetry extrapolations. Alternately, the HAP Task Force could use the amount metabolized per day normalized to liver weight as a target tissue surrogate, if first pass metabolism in the liver is relatively low ( i. e., less than 15%). The HAP Task Force should further discuss this point and provide the rationale for the approach selected as a component of protocol development under Tier II activities.

The above discussion on dose metrics underscores the need for the HAP Task Force to apply the expanded Tier I PBPK model for TCE in developing Tier II study protocols and proposed dose selections for newtesting to be performed under Tier II. For example, model simulations for several of the dose metrics will be sensitive to how the dose is modeled via drinking water. EPA believes that the details of such considerations must be fully transparent prior to conduct of the Tier II studies. While the ultimate selection ofthe most appropriate dose metric will be based upon the study results, EPA believes that clarification ofthe options for a route dosimetry extrapolation relative to each endpoint ( e. g., the probable dose metric and the preferred pattern to model a drinking water exposure) are best incorporated into the Tier II protocol development.

D. NATURE ANDSCOPE OF ANYADDITIONAL WORK The EPA Program Review ofthe ECA for TCE identified additional considerations for the HAP Task Force to incorporate into Tier II testing and Extrapolation Reporting.

1. Applying PK/ MECH data and the TCE model in Tier II EPA notes that it would be highly advantageous to use the PBPK model developed in Tier I to simulate various dose metrics for the proposed Tier II study designs as part ofthe protocol development and selection of the appropriate drinking water concentrations. Applying the PBPK model in this way will improve the design ofthe studies by identifying whether the modeling predicts kinetically distinguishable internal dose metrics for the concentrations proposed. In addition, this will support choosing the most scientifically 8 defensible dose metric based upon comparisons with the dose response data from existing studies. Applying the current iteration ofthe PBPK model to each ofthe Tier II study designs is also an important exercise to further evaluate whether the pharmacokinetic studies in Tier I adequately characterized the dose ranges specified in Tier II studies, and whether the parameter estimates, particularly for Vmax, are adequate. Ideally, the blood concentrations in the various pharmacokinetic studies should span the relevant range to be simulated in the toxicity studies. If the doses in the toxicity studies range from sub saturating to saturating, then an additional PK study at a high dose may be needed to better characterize Vmax in the rats. Conversely, if dose levels in the toxicity study lead to essentially sub saturating internal levels ( evaluated by comparing the venous concentration exiting the liver with the Km), then the relative importance ofVmax is diminished and additional data to refine Vmax may not be needed.

2. Modeling Drinking Water EPA notes that there are a number of dosing patterns that can be used in the PBPK model to simulate the drinking water exposures proposed in the Tier II study protocols or cited in the existing carcinogenicity and immunotoxicity studies. While the total amount metabolized ( normalized by liver weight) may not be very sensitive to one or another drinking water pattern, estimates of Cmax will be highly dependent upon the pattern used in the simulation, and it is unclear the degree to which AUC would be affected. Real time continuous measures ofdrinking water behavior during toxicity studies to be performed under Tier II are not expected. Modeling approaches for water consumption are traditionally based upon an estimate of the average behaviors of rats and mice. Yuan ( 1993) describes some modeling approaches to food and water consumption using drinking water data previously published by Johnson and Johnson ( 1990). The HAP Task Force may want to propose other approaches to modeling drinking water behavior. Regardless of the modeling pattern selected for Tier II, EPA believes that it is critical for the HAP Task Force to incorporate the rationale for selecting a modeling approach ( acceptable to EPA) in the Tier II study protocols, because this will have a significant effect on at least one ofthe dose metrics and potentially impact route dosimetry extrapolations for the Tier II endpoints.

In addition, EPA believes that the HAP Task Force can take advantage of both the available data from extant drinking water toxicity studies of TCE and the data to be collected from Tier II testing to better understand drinking water patterns relevant to TCE exposures. For example, the White et al., 1985 publications on immuntoxicity and subchronic toxicity in the mice provide data on average drinking water consumption for male and female animals during each month of the 90 day study. These studies show that the high dose males have a significant reduction in water consumption and body weight. Such data may be relevant for PBPK modeling, especially if such a high dose was subsequently used in a benchmark dose determination. Whether there will be any effects on water consumption in the Tier II studies remains to be seen; however, incorporating considerations for the effects observed in the White et al. ( 1985) publications would further refine the model.

9 V. CONCLUSION AND RECOMMENDATIONS The EPA Program Review concludes that the TCE Tier I Program Review Testing PK/ MECH data development, PBPK model development, and associated reports are acceptable to inform and support Tier II testing for the endpoints and associated route to route dosimetry extrapolation reporting specified in Table 1 of the ECA for TCE. The ORD/ NCEA recommends that OPPT notify the Companies in writing that Tier II endpoint testing and computational routeto route dosimetry extrapolation reporting can proceed for the endpoints included in Tier II ofthe ECA for TCE. EPA's Program Review identified the need to incorporate additional model simulations to be conducted in conjunction with the Tier II Testing protocol development and route dosimetry extrapolation reporting activities.

10 VI. REFERENCES Andersen, M. E., 11.3. Clewell, III and C. B. Frederick. 1995. Applying simulation modeling to problems in toxicology and risk assessment A short perspective. Tox. Appl. Pharm. 133 187.

Buchanan, J. R., L. T. Burka, and R. L. Melnick. 1997. Purpose and guidelines for toxicokinetic studies within the National Toxicology Program. Environ. Hlth. Perspect. 105( 5): 468 471.

Doherty AT, Ellard S, Pany EM, et al. 1996. An investigation into the activation and deactivation of chlorinated hydrocarbons to geneotoxics in metabolically competent human cells. Mutagenesis 11 ( 3): 247 274.

HAP Task Force 1996. Proposal for Pharmacokinetics Study of 1,1 ,2 Trichloroethane. Prepared by ChemRisk  A Division of McLaren! Hart. ( Available from EPA e Docket OPPT 2002 0056).

Johnson, R. F. and Johnson, A. K. ( 1990) Light dark cycle modulates drinking to homeostatic challenges. Am J Physiol R 259, 103 5 1042 Kohn, M. C. 1997. The importance ofanatomical realism for validation of physiological models of disposition ofinhaled toxicants. Tox. Appi. Pharm. 147: 448 458.

Mazzulo M, Colacci A, Grilli 5, et al. 1986. l, l, 3 Trichlorethane: Evidence ofgenotoxicity from short term tests. Jpn J Canc Res 77: 532 539,

NCI. 1978. Bioassay of l, l, 2 trichloroethane for possible carcinogenicity. Report. ISS DHEW/ PUB/ NIH 78 1324. NCI CG TR 74. PB 283337.

Sanders VM, Whiet KL, Shopp GM, and Munson AE. 1985. Humoral and cell mediated immune status ofmice exposed to 1,1 ,2 trichloroethane. Drug and Chemical Toxicology. 8( 5): 357 372.

TinbergN and Ingelman SundbergM ( 1996) Expression, catalytical activity, and inducibility of cytochrome P450 2El ( CYP2E1) in the rat central nervous system. J Neurochem 67( 5): 2066 2073.

Ultman, J. S. 1994. Dosimetry modeling: Approaches and issues. Inhal. Toxicol. 6: 59 71.

U. S. Environmental Protection Agency 1997. Preliminary EPA Technical Analysis ofProposed Industry Pharmacokinetics ( PK) Strategy for 1,1 ,2 Trichloroethane. ( Available from the OPPTS DocketNo. 42l87B).

11 Woodruff, T. J., F. Y. Bois, D. Auslander and R. Spear. 1992. Structure and parameterization of pharmacokinetics models: Their impact on model predictions. Risk Anal. 12: 189 201.

Yuan, J. ( 1993) Modeling blood/ plasma concentrations in dose feed and dose drinking water toxicology studies. Toxicol Appl Pharmacol 119, 13 1 141.

12 VII. LIST OF CONTRIBUTORS The following table lists EPA staff and their contributions in the preparation of this report on EPA's Program Review segment ofthe ECA for TCE.

TrF. 1~' 1' ATier I Prnorr~ mP~ view~ t~ ff Scientific Analysis ~ 4' i) ~ ... 1 ~ ~ ~ ~ ~ ~ ~ i1II~~ UI 1~~ uaI tat auu IJL~ vUIup1IavaaI ~., IIItv ui i uaauLIuJa i a ~ v~ aatauaa auu i Technical Review Workgroup j ECA Coordination Workgroup ORD/ NHEERL ORD/ NCEA ORD/ NCEA Hugh Barton Rob DeWoskin Michel Stevens EPA Reviewers Annie Jarabek Gary Foureman Woody Setzer Elaina Kenyon Marina Evans Report Preparation and Coordination Richard Leukroth OPPT / CCD John Schaeffer OPPT / CCD EPA Reviewer Laura Bunte ORD/ NCEA ORD/ NCEA ORD/ NHEERL ORD/ NHEERL ORD/ NHEERL OPPT/ CCD 13 APPENDIX 1 ECA required testing, Test Standards, Reporting and Other Requirements for 1,1 ,2 Trichloroethane 14 Appendix 1. ECA REQUIRED TESTING, TEST STANDARDS, REPORTING AND OTHER REQUIREMENTS FOR 1,1,2 TRICHLOROETHANE ~ As specified in Part VI. A. of the TCE ECA, EPA has determined that the cytogenicity studies reported by Mazzulo eta!. ( 1986) and Doherty et al. ( 1996) adequately fulfill the HAPs rulemaking testing requirement for in vivo cytogenicity testing for 1,1,2 trichloroethane. TIER I HAPs Testing for TCE Test Standard Acute Toxicity ( inhalation)

Subchronic Toxicity ( inhalation) § 799.9135 ( as annotated in Appendix D. 1 ofthe TCE ECA)

in vivo cytogenetics § 799.9346 ( as annotated in Appendix D. 2 ofthe TCE ECA)

See Appendix E. 1 of the TCE ECA5 15 TIER I Program Review Testing for TCE6 Test Standard PK] MECH data to support model validation and As described in Appendix C( l) of verification of oral to inhalation extrapolation the TCE ECA. for the following data needs in the F344 rat7: a. Neurotoxicity5 b. Developmental toxicity5 c. Reproductive toxicity5 PK/ MECH data to support model development, As described in Appendix C( 1 3) validation, and verification oforal to inhalation of the TCE ECA. extrapolation for the following data needs in the mouse: a. Developmental toxicity8 a. Immunotoxicity9 b. Carcinogenicity1 ° PBPK model simulations11 As described in Appendix C( l  5) ofthe TCE ECA 6 As described in Part VI. C. ofthe TCE ECA, before work under the Tier II testing segment is conducted, EPA will conduct a Program Review of the Tier I Program Review Testing data and data from other studies acceptable to EPAthat could be used to inform quantitative computational dosimetry modeling for route to route extrapolations.

`~ Previously published inhalation PBPK model ( Gargas et a!., 1989; 1990) to be extended and validated to ( 1) periodic inhalation exposures based on PKIMECH data to be acquired as part ofthe 90 day inhalation study and ( 2) oral administration via either corn oil gavage or drinking water.

8 Drinking water administration.

Relevant to the extant data in mice administered via drinking water of Sanders et al. ( 1985).

10 Relevant to the extant data in mice administered via corn oil gavage of NCI ( 1978).

11 The model simulations are to ( a) evaluate model validation and ( b) model verification by demonstrating the accuracy of quantitative route to route extrapolations in order to evaluate the acceptability of: ( 1) neurotoxicity testing oforal exposure via drinking water in rats; ( 2) developmental toxicity testing via drinking water in rats and mice; ( 3) reproductive toxicity testing via drinking water in rats; ( 4) extant immunotoxicity data ( SRBC assay) of Sanders et al. ( 1985) in mice via drinking water; and ( 5) extant NCI ( 1978) cancer bioassay data in mice via corn oil gavage.

16 12 Quantitative route to route extrapolation documented graphically and with tabular data. Ability to characterize parent and metabolite blood and CNS time course data, if possible, for both oral and inhalation routes demonstrated.

~ Quantitative route to route extrapolation documented graphically and with tabular data; parent and total amount metabolized in a 24 hour period to be explored as a potential dose metric.

14 Quantitative route to route extrapolation documentedgraphically and with tabular data using parent compound as dose metric.

~ Quantitative route to route extrapolation based on the PKIMECH data developed under this ECA and the data of Sanders eta!. ( 1985) documented graphically and with tabular data using parent compound as dose metric.

16 Quantitative route to route extrapolation based on the PKIMECH data developed under this ECA and the data of NCI ( 1978) documented graphically and with tabular data using the total amount metabolized in a 24 hour period and parent compound as dose metric. Dose response analysis to be performed using genotoxic assumption ( linear extrapolation) procedure. Tier II Testing and/ or Extrapolation Renortirn!'

Acute Neurotoxicity: a) testing by the oral route Test Standard b) route to route extrapolation' 2 Subchronic Neurotoxicity: § 799.9620 ( as annotated in Appendix D. 3 ofthe TCE ECA)

a) testing by the oral route Appendix C ofthe TCE ECA b) route to route extrapolation' ° § 799.9620 ( as annotated in Appendix D. 3 of the TCE ECA)

Developmental Toxicity: a) testing by the oral route Appendix C ofthe TCE ECA b) route to route extrapolation' 3 § 799.9370 ( as annotated in Appendix D. 4 ofthe TCE ECA)

Reproductive toxicity: a) testing by the oral route Appendix C ofthe TCE ECA b) route to route extrapolation14 § 799.9380 ( as annotated in Appendix D. 5 ofthe TCE ECA)

Immunotoxicity ( extrapolation of extant data)' 5 Appendix C ofthe TCE ECA Carcinogenicity ( extrapolation of extant data) 16 Appendix C ofthe TCE ECA Appendix C 17


[Federal Register: April 19, 2010 (Volume 75, Number 74)]
[Proposed Rules]
[Page 20322-20323]
[DOCID:fr19ap10-15]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-1135; Airspace Docket No. 09-ANM-20]

Proposed Amendment of Class E Airspace; Kelso, WA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E airspace at Southwest
Washington Regional Airport, Kelso, WA, to accommodate aircraft using
the new Area Navigation (RNAV) Global Positioning System (GPS) Standard
Instrument Approach Procedures (SIAP's) at Southwest Washington
Regional Airport. The FAA is proposing this action to enhance the
safety and management of aircraft operations at the airport. This
action will also change the airport name from Kelso-Longview Airport.

DATES: Comments must be received on or before June 3, 2010.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590;
Telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2009-
1135; Airspace Docket No. 09-ANM-20, at the beginning of your comments.
You may also submit comments through the Internet at http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA

2009-1135 and Airspace Docket No. 09-ANM-20) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2009-1135 and Airspace Docket No. 09-ANM-20.''
The postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://
www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_
amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue, SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying Class E airspace extending
upward from 700' above the surface at Southwest Washington Regional
Airport, Kelso, WA. Additional controlled airspace is necessary to
accommodate aircraft using the new RNAV (GPS) SIAP's at Southwest
Washington Regional Airport. This action would enhance the safety and
management of aircraft operations at the airport. This action also
would change the airport name from Kelso-Longview Airport, to Southwest
Washington Regional Airport.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9T, signed August 27, 2009, and effective September 15,
2009, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (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); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified that this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would add additional controlled airspace at Southwest Washington
Regional Airport, Kelso, WA.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of the FAA Order
7400.9T, Airspace Designations and Reporting Points, signed August 27,
2009, and effective September 15, 2009 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ANM WA, E5 Kelso, WA [Modified]

Southwest Washington Regional Airport, WA
    (Lat. 46[deg]07'05'' N., long. 122[deg]53'54'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of the Southwest Washington Regional
Airport, and 2.4 miles each side of the 290[deg] bearing of the
airport extending 9.1 miles west, and 4.3 miles each side of the
337[deg] bearing of the airport extending 22.2 miles northwest, and
5.8 miles west and 3 miles east of the 012[deg] bearing of the
airport extending 18.2 miles north of the airport.

    Issued in Seattle, Washington, on April 7, 2010.
Robert E. Henry,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2010-8853 Filed 4-16-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 172 (Wednesday, September 5, 2018)]
[Notices]
[Pages 45164-45165]
[FR Doc No: 2018-19258]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Thursday, September 6, 2018.

PLACE: Closed Commission Hearing Room 10800.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    Commissioner Jackson, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.

CONTACT PERSON FOR MORE INFORMATION: For further information and to
ascertain what, if any, matters have been added, deleted or postponed;
please contact Brent J. Fields from the Office of the Secretary at
(202) 551-5400.

    Dated: August 30, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018-19258 Filed 8-31-18; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Notices]
[Page 42906]
[DOCID:fr25au09-84]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Joint Meeting of the Anesthetic and Life Support Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee;
Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.

    Name of Committees: Anesthetic and Life Support Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory
Committee.
    General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 24, 2009,
from 8 a.m. to 4:30 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village
Ave., Gaithersburg, MD. The hotel phone number is<PHONE_NUMBER>.
    Contact Person: Kalyani Bhatt, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD
20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area),
codes<PHONE_NUMBER> or<PHONE_NUMBER>. Please call the Information Line for
up-to-date information on this meeting. A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published
quickly enough to provide timely notice. Therefore, you should
always check the agency's Web site and call the appropriate advisory
committee hot line/phone line to learn about possible modifications
before coming to the meeting.
    Agenda: On September 24, 2009, the committees will begin with a
closed session from 8 a.m. to 9:15 a.m. Following the closed
session, from 9:15 a.m. to 4:30 p.m., the meeting will be open to
the public.
    The committees will discuss new drug application (NDA) 22-272,
OXYCONTIN (oxycodone hydrochloride controlled-release) Tablets,
Purdue Pharma L.P., and its safety for the proposed indication of
management of moderate to severe pain when a continuous, around-the-
clock analgesic is needed for an extended period of time. This
formulation was previously reviewed and discussed by these
committees on May 5, 2008, and will be considered again in light of
new data.
    FDA intends to make background material available to the public
no later than 2 business days before the meeting. If FDA is unable
to post the background material on its Web site prior to the
meeting, the background material will be made publicly available at
the location of the advisory committee meeting, and the background
material will be posted on FDA's Web site after the meeting.
Background material is available a http://www.fda.gov/
AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee link.
    Procedure: On September 24, 2009, from 9:15 a.m. to 4:30 p.m.,
the meeting is open to the public. Interested persons may present
data, information, or views, orally or in writing, on issues pending
before the committee. Written submissions may be made to the contact
person on or before September 10, 2009. Oral presentations from the
public will be scheduled between approximately 1 p.m. and 2 p.m.
Those desiring to make formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
September 1, 2009. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person
will notify interested persons regarding their request to speak by
September 2, 2009.
    Closed Presentation of Data: On September 24, 2009, from 8 a.m.
to 9:15 a.m., the meeting will be closed to permit discussion and
review of trade secret and/or confidential information (5 U.S.C.
552b(c)(4)). The meeting will be closed to permit discussion of
confidential information regarding detailed protocols to evaluate
the formulation of the drug product. Persons attending FDA's
advisory committee meetings are advised that the agency is not
responsible for providing access to electrical outlets.
    FDA welcomes the attendance of the public at its advisory
committee meetings and will make every effort to accommodate persons
with physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kalyani Bhatt at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory
committee meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for
procedures on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20376 Filed 8-24-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Notices]
[Page 34653]
[FR Doc No: 2017-15647]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER17-437-005.
    Applicants: Marcus Hook 50, L.P.
    Description: Compliance filing: Settlement rate implementation to
be effective 12/28/2016.
    Filed Date: 7/19/17.
    Accession Number: 20170719-5086.
    Comments Due: 5 p.m. ET 8/9/17.

    Docket Numbers: ER17-1320-001.
    Applicants: Odyssey Solar, LLC.
    Description: Report Filing: Supplement to 4 to be effective N/A.
    Filed Date: 7/19/17.
    Accession Number: 20170719-5090.
    Comments Due: 5 p.m. ET 8/9/17.

    Docket Numbers: ER17-2112-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2017-07-19_Planning Resource
Auction Offer Window Filing to be effective 9/18/2017.
    Filed Date: 7/19/17.
    Accession Number: 20170719-5148.
    Comments Due: 5 p.m. ET 8/9/17.

    Docket Numbers: ER17-2113-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Request for Waiver of Midcontinent Independent System
Operator, Inc.
    Filed Date: 7/19/17.
    Accession Number: 20170719-5179.
    Comments Due: 5 p.m. ET 8/9/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 20, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-15647 Filed 7-25-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Page 63240]
[FR Doc No: 2015-26460]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3373-EM; Docket ID FEMA-2015-0002]

South Carolina; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of South Carolina (FEMA-3373-EM), dated October
3, 2015, and related determinations.

DATES: Effective date: October 3, 2015.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 3, 2015, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in the State of
South Carolina resulting from severe storms and flooding beginning
on October 1, 2015, and continuing, are of sufficient severity and
magnitude to warrant an emergency declaration under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (``the Stafford Act''). Therefore, I declare that such
an emergency exists in the State of South Carolina.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

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

    All 46 South Carolina counties and the Catawba Nation for
emergency protective measures (Category B), limited to direct
federal assistance, under the Public Assistance program.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2015-26460 Filed 10-16-15; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: October 3, 2007 (Volume 72, Number 191)]
[Rules and Regulations]
[Page 56266-56267]
[DOCID:fr03oc07-9]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30572; Amdt. No. 3238]

Standard Instrument Approach Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule amends Standard Instrument Approach Procedures
(SIAPs) for operations at certain airports. These regulatory actions
are needed because of changes in the National Airspace System, such as
the commissioning of new navigational facilities, adding of new
obstacles, or changing air traffic requirements. These changes are
designed to provide safe and efficient use of the navigable airspace
and to promote safe flight operations under instrument flight rules at
the affected airports.

DATES: This rule is effective October 3, 2007. The compliance date for
each SIAP is specified in the amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of October 3, 2007.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
.

    Availability--All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420), Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(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);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC on September 21, 2007.
James J. Ballough,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal regulations, Part 97, 14 CFR part 97, is amended by amending
Standard Instrument Approach Procedures, effective at 0901 UTC on the
dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, and
97.35  [Amended]

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, ISMLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

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        FDC date                State                City                   Airport           FDC No.                        Subject
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08/29/07................  TX                Corpus Christi........  Corpus Christi Intl...       7/4996  Rescind Notam Published In TL 07-21. TKOF Mins
                                                                                and Obstacle DP, Orig.
09/17/07................  MO                Maryville.............  Northwest Missouri           7/6239  Take-Off Minimums and (Obstacle) Departure
                                                                     Regional.                            Procedures Amdt 2.
09/17/07................  NM                Tucumcari.............  Tucumcari Muni........       7/6242  Take-Off Minimums and (Obstacle) Departure
                                                                                Procedures Amdt 2.
09/06/07................  GA                Perry.................  Perry-Houston County..       7/6070  VOR or GPS-A, Amdt 5.
09/06/07................  GA                Perry.................  Perry-Houston County..       7/6078  NDB or GPS Rwy 36, Amdt 3.
09/10/07................  HI                Honolulu..............  Honolulu Intl.........       7/6466  RNAV (RNP) Rwy 26L, Orig.
09/11/07................  MD                College Park..........  College Park..........       7/6545  TKOF Mins and Obstacle DP, Amdt 3A.
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[FR Doc. E7-19242 Filed 10-2-07; 8:45 am]

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