April 12, 2013

EPA-HSRB-13-01

Glenn Paulson, PhD
EPA Science Advisor
Office of the Science Advisor
1200 Pennsylvania Avenue, NW
Washington, DC 20460

Subject: January 17, 2013 EPA Human Studies Review Board Meeting Report

Dear Dr. Paulson,

      The United States Environmental Protection Agency (EPA or Agency) requested that the Human Studies Review Board (HSRB) provide scientific and ethics reviews of one completed study involving intentional exposure of human subjects to pesticides; specifically, a study of the Antimicrobial Exposure Assessment Task Force II (AEATF) scenario to determine dermal and inhalation exposures associated with the manual pouring of liquid antimicrobial products (AEA-05).

 	The enclosed report provides the Board's response to the three EPA charge questions presented at the January 17, 2013 meeting.

A completed study report from the Antimicrobial Exposure Assessment Task Force II (AEATF) in which the dermal and inhalation exposure of professional janitorial workers was monitored as they poured liquid antimicrobial pesticide products from conventional or reduced-splash containers into different sizes and types of receiving containers.

Science

   * The Board agreed with the Agency's conclusion that the completed liquid pour study was conducted in a manner faithful to the design and objectives of the amended protocol and governing documents of AEATF.
   * The Board determined that the Agency identified and adequately characterized some, not all, of the limitations that should be considered when using the data in estimating the exposure of people who pour liquid antimicrobial pesticide products.  Additional limitations, statistical analyses, and technical recommendations merit attention before the data are used in exposure algorithms for estimating human exposures.

Ethics

   * The Board concurred with the Agency's assessment (Leighton, Cohen, October, 9 2012; Sherman, October, 9 2012) that the proposed research is likely to meet the applicable requirements of 40 CFR part 26, subparts K and L.

Sincerely,

Rebecca T. Parkin, PhD, MPH
Chair
EPA Human Studies Review Board
                                    NOTICE

      This report has been written as part of the activities of the EPA Human Studies Review Board, a Federal advisory committee providing advice, information and recommendations on issues related to scientific and ethical aspects of human subjects research. This report has not been reviewed for approval by the Agency and, hence, the contents of this report do not necessarily represent the view and policies of the Environmental Protection Agency, nor of other agencies in the Executive Branch of the Federal government, nor does the mention of trade names or commercial products constitute a recommendation for use. You may obtain further information about the EPA Human Studies Review Board from its website at http://www.epa.gov/osa/hsrb. You may also contact the HSRB Designated Federal Officer, via e-mail at<EMAIL_ADDRESS>
      In preparing this document, the Board carefully considered all information provided and presented by the Agency presenters, as well as information presented by public commenters. This document addresses the information provided and presented within the structure of the charge by the Agency.
                      US ENVIRONMENTAL PROTECTION AGENCY
                          HUMAN STUDIES REVIEW BOARD

Chair

Rebecca Parkin, PhD, MPH, Professorial Lecturer (EOH), School of Public Health and Human Services, The George Washington University, Washington, DC

Vice Chair

Jewell H. Halanych, M.D., Assistant Professor, Department of Medicine, Division of Preventative Medicine, University of Alabama at Birmingham, Birmingham, AL

Members

George Fernandez, PhD, Professor of Applied Statistics, Director of the University of Nevada-Reno Center for Research Design and Analysis, University of Nevada-Reno, Reno, NV

Sidney Green, Jr., PhD, Fellow of the ATS, Professor, Department of Pharmacology, Howard University College of Medicine, Washington, DC

Elizabeth Heitman, Ph.D., Associate Professor of Medical Bioethics, Center for Biomedical Bioethics and Society, Vanderbilt University Medical Center, Nashville, TN

Dallas E. Johnson, PhD, Professor Emeritus, Department of Statistics, Kansas State University, Manhattan, KS

John C. Kissel, PhD, Professor, Department of Environmental and Occupational Health, School of Public Health, University of Washington, Seattle, WA

José E. Manautou, PhD, Associate Professor of Toxicology, Department of Pharmaceutical Science, University of Connecticut School of Pharmacy, Storrs, CT

William Popendorf, PhD, MPH, Professor Emeritus, Department of Biology, Utah State University, Logan, UT

†Nu-May Ruby Reed, Ph.D., D.A.B.T., Retired Staff Toxicologist, California Environmental Protection Agency (Cal/EPA), Department of Pesticide Regulation, Davis, CA

*Bernard A. Schwetz, D.V.M., Ph.D., Retired Director, Office of Human Research Protections, Department of Health & Human Services, Cadott, WI

Virginia Ashby Sharpe, PhD, Medical Ethicist, National Center for Ethics in Health Care, Veterans Health Administration, Washington, DC
Linda J. Young, PhD, Professor, Department of Statistics, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL

Human Studies Review Board Staff

Jim Downing, Executive Director, Human Studies Review Board Staff, Office of the Science Advisor, United States Environmental Protection Agency, Washington, DC

* Not present on January 17, 2013.
† Participated in the January 17, 2013 meeting via telepresence.
INTRODUCTION

      On January 17, 2013, the United States Environmental Protection Agency's (EPA or Agency) Human Studies Review Board (HSRB) met to address the scientific and ethical charge questions related to one completed study; namely, a study of the Antimicrobial Exposure Assessment Task Force II (AEATF) scenario to determine dermal and inhalation exposures associated with the manual pouring of liquid antimicrobial products (AEA-05).

REVIEW PROCESS

      On January 17, 2013, the Board conducted a public face-to-face meeting in Arlington, Virginia. Advance notice of the meeting was published in the Federal Register as "Human Studies Review Board; Notice of Public Meeting" (76 Federal Register 187, 59697).

      Following welcoming remarks from Agency officials, the Board heard presentations from EPA on the following topic: the Antimicrobial Exposure Assessment Task Force II (AEATF) scenario to determine dermal and inhalation exposures associated with the manual pouring of liquid antimicrobial products (AEA-05).

      The Board asked the Agency presenters clarifying questions about scientific aspects of the study.

Public oral comments, including clarifications about the study conduct, were provided by:

      Ms. Leah Rosenheck, President, LR Risk Consulting, Inc. (representing the Antimicrobial Exposure Assessment Task Force II)

No written public comments were submitted.

      For their evaluation and discussion, the Board considered materials presented at the meeting, oral comments, and Agency background documents (e.g., the proposed study protocol; AEATF governing documents; standard operating procedures; institutional review board documentation; the HSRB's final report following its October 19, 2011, review of the protocol; AEATF's final report, tables, statistical analyses and SAS code for the study; and the Agency's science and ethics reviews of the completed study). A comprehensive list of background documents is available online at http://www.epa.gov/hsrb/.

CHARGE TO THE BOARD AND BOARD RESPONSE
Assessment of Proposed AEATF Research Study AEA05: A Study for Measurement of Potential Dermal and Inhalation Exposure During Manual Pouring of a Liquid Containing an Antimicrobial.

Overview of the Study

      AEATF II's liquid pour study (AEA-05) was designed to measure dermal and inhalation exposures to workers and consumers when they manually pour liquid antimicrobial products from and into a variety of commonly used containers in differing scenarios (e.g., various heights, pre-measured or not).  Specifically, the AEATF sought to develop unit exposures (UEs) for conventional pour (CP) and reduced splash (RS) source containers.  The Agency plans to use the resulting data in exposure algorithms to estimate human exposures from pouring liquid antimicrobial products in diverse settings.
      The protocol for this completed study was reviewed by the EPA and then on October 19, 2011, by the HSRB.  Following recommendations of the Agency and the HSRB, the protocol was revised by the sponsors and approved by the Independent Investigational Review Board, Inc., (IIRB).
      In January and February 2012, the sponsors used notices in two local newspapers and one regional bilingual publication to recruit professional janitorial workers.  After screening respondents and obtaining informed consent, 22 people were enrolled in the study; 18 were study participants and four were alternates.  No persons under age 18 and no pregnant or nursing women participated in this study.
      From February 16 - 22, 2012, the study was conducted in two equal-sized rooms at a laboratory in Concord, Ohio.  Two low-volatility active ingredients, ADBAC (N-alkyl dimethyl benzyl ammonium chloride; Maquat DS 1412-10%) and DDAC (didecyl dimethyl ammonium chloride; Maquat WP), were used in the RS and CP scenarios respectively.  Participants were randomized to pour first from one type of source container (holding from 24 ounces to 5 gallons) into various receiving containers (from 2- to 50-gallon sizes).  They were randomly assigned to pour different amounts of each substance (e.g., from 40 ounces to 20 gallons in the CP scenario, and from 60 ounces to 30 gallons in the RS scenario) and instructed to pour the liquids as they normally would.  Each of the 18 participants poured the two substances sequentially for a total of 36 Monitoring Events (MEs).  The amount poured was measured by weighing the containers before and after each ME.  Participants were observed during the MEs; i.e., staff recorded environmental conditions, notable activities and events and took photos and videos during each ME.  Participants wore two whole-body dosimeters (WBD) (a one-piece inner WBD and a long-sleeved shirt and long pants for the outer WBD); these were sectioned into 8 specified pieces for separate analysis.  Hand washes and face and neck wipes were also used to assess dermal exposures to unclothed portions of the body.   All participants wore safety glasses, but no participants wore gloves during the MEs.  Each participant's breathing zone inhalation exposure was measured using an OSHA Versatile Sampler (OVS) tube attached to his/her shirt collar and linked to a personal sampling pump.
      Unit Exposures (i.e., expected external exposures) were normalized to pounds active ingredient handled (AaiH).  Statistical analyses were conducted in SAS using three modeling methods: empirical simple random sampling, lognormal simple random sampling, and lognormal mixed models.
      The sponsors found that pouring liquids into spray bottles resulted in the highest levels of dermal exposure, due to drips and spills; consequently, the AaiH:exposure relationship was not log-log-linear.  Nearly half of the inhalation exposures were below the limit of quantification (LOQ); the RS containers typically resulted in lower values.  The study design yielded data which met the 3-fold accuracy criterion, except for the spray bottles (k=3.6).
      The Agency concluded that the results may be used for assessing exposures related to labeled uses of liquid pesticides that require open pouring.
Science

Charge to the Board
   * Was the research reported in the Antimicrobial Exposure Assessment Task Force II (AEATF) completed liquid pour study report faithful to the design and objectives of the protocol and governing documents of AEATF?
   * Has EPA adequately characterized, from a scientific perspective, the limitations on these data that should be considered when using the data in estimating the exposure of people who pour liquid antimicrobial pesticide products?
Board Response to the Charge

 HSRB Recommendation

   * In response to the first question, the Board agreed with the Agency's conclusion that the completed liquid pour study was conducted in a manner faithful to the design and objectives of the amended protocol and governing documents of AEATF.
   * The Board determined that the Agency identified and adequately characterized some, not all, of the limitations that should be considered when using the data in estimating the exposure of people who pour liquid antimicrobial pesticide products.  Additional limitations, statistical analyses and technical recommendations merit attention before the data are used in exposure algorithms for estimating human exposures.
HSRB Detailed Recommendations and Rationale
      The study report is well-documented with useful observational notes.  While the justification to split out the spray bottles as a separate scenario was not explained clearly, the HSRB agrees with the logic of the decision.
      During deliberation of additional limitations and technical and statistical concerns, the HSRB suggested a number of methods which could be used to strengthen the study analysis and maximize the appropriate future use of the data in exposure algorithms.  Although the following comments may appear extensive, many have both positive and negative impacts on how these data might be used or interpreted.
      1.    Limitations
      The Board agrees with most of the Agency-identified limitations that should be considered when using the data in estimating the exposure of people who pour liquid antimicrobial pesticide products; however, it has numerous science-based comments and additions.  The first seven bullets refer to the limitations listed by the Agency as a series of eight "items" (Leighton and Cohen, EPA Science Review, 2012, 45-47).
   o The first part of item #2 (Leighton and Cohen, EPA Science Review, 2012, 46) discusses the study design limitation imposed by using only occupational workers; i.e., custodians or janitors.  The Board does not fully support the Agency's conclusion that the fact that "the test subjects spilled the product on their hands when performing their pouring tasks indicated that perhaps pouring liquids is not an experienced-based skill."  Notes in the Observations of Monitoring Events indicate that many of the handlers (8 out of 18 for ≈ 44%) changed their procedures as they progressed in their assigned task in ways that reduced further dripping of the product onto the outside of the product and/or receiving container (Rosenheck, Final Report (AEA-05), 2012, 164-199) .  This observation (along with the fact that 5 of these 8 changes were noted on the subject's second of two MEs) suggests that the participants' prior work "experience" was not as strong a factor in their handling of their assigned containers as the selection criteria might suggest.  However, these observations also suggest that the exposures measured on these occupational workers may not be as different from residential users as was suggested during the Board's protocol review (HSRB, October 2011 Meeting Report, 12-13).

   o Another limitation, indirectly related to the first part of item #2 (Leighton and Cohen, EPA Science Review, 2012, 46), is that the repeated exposures to containers contaminated by previous spillage (as allowed by the study design) may have resulted in dermal exposures much greater than expected for a more typical task of pouring into spray bottles once-daily.  The reason for this suggestion is that the protocol called for pouring from the same product container (and measuring cup, when applicable) to fill multiple (10 or 15) spray bottles, which occurred within a short time (13 to 22 minutes).  While Table 6 of the Final Report indicates that virtually all of these particular custodial workers poured a liquid disinfectant at least weekly (with about 70% listed as daily) (Rosenheck, Final Report (AEA-05), 2012, 84),  it seems unlikely that in their normal work they would fill so many spray bottles in such rapid succession.  In the time between their more normal occupational fillings, the liquid that dripped down the side of a container during one filling session would have either been rinsed off, wiped off, or had a chance to dry before the next session started.  In the opinion of the Board, based on both past experience with liquid exposure studies and physical principles, liquid ingredients on the surface of a container would transfer to a handler's skin much more readily than would a dried residue.  Neither drying nor wiping was allowed within the approved protocol.  While the use and storage of a rag used to wipe the drips would have been a new variable, the resulting exposures as tested were almost certainly larger than would result from normal daily uses in either an occupational or a residential setting.

The Board recommends that the registrants and Agency take note of the success of some participants in evolving their work practices, thereby reducing their dripping and splashing.  Should the need arise in the future to reduce dermal exposures, both better label instructions to improve work practices and better container designs to reduce dripping could be explored to reduce exposures more consistently, not only while filling spray bottles but also for other pour scenarios.

   o The second part of item #2 stated that "also part of the [study] design limitation was the fact that the study was conducted indoors" (Leighton and Cohen, EPA Science Review, 2012, 46). The Board noted in their review of these protocols that outdoor exposures might be larger; "Air velocity [from wind] outdoors is likely to be more variable (particularly on the high-end) than indoors" (HSRB, October 2011 Meeting Report, 12).  Discussion at the meeting did not support the subsequent AEATF's response that "Exposure data indicate that the handling and use of chemicals indoors tend to result in higher exposures than outdoors due to the restricted potential for dilution of airborne residues" (Leighton and Cohen, EPA Science Review, 2012, 7).   In the opinion of the Board, at least peak exposures outdoors may be larger than doing the same task indoors due to differences in both airflow patterns related to wind outdoors and psychological factors causing less of a concern for drips and spills outdoors than indoors.

   o Item #2 did not mention a lack of information within the study report on ventilation velocity or handler orientation within that airflow (Leighton and Cohen, EPA Science Review, 2012, 46).  The HSRB's review of these protocols stated "... the focus of interest in ventilation should be on the local air flow between the pouring operation (the source of exposure) and the handler."  Further, the Board suggested that "...at the very least, that pattern should be measured before and/or after exposures and the orientation between the source and each handler should be documented for each ME. Alternatively, the room's setup and the orientation between the source and handler could be varied (e.g., rotated 90°) either within or among MEs" (HSRB, October 2011 Meeting Report, 11).  The AEATF's response indicates in part that "More details about how the airflow will be measured will be included in the protocol" and "...the orientation of each test subject in the room with respect to the direction of air flow and the containers he is pouring will be documented" ((Leighton and Cohen, EPA Science Review, 2012, 9).  While the room diagrams and photos in the AEATF final report provide some constraints and examples (respectively) of the orientation within the room (Rosenheck, Final Report (AEA-05), 2012, 151-153), the report did not contain any details regarding either the airflow velocity or the orientation of individual handlers.  Thus, the Agency is unable to evaluate the potential for a consistent airflow direction or orientation to have caused the average inhalation route to be either higher or lower than would have been caused by random or variable airflows.  Conversely, if the ventilation systems in the test facilities have not been modified since the exposure tests were conducted, it may still be possible (even at this late date) to conduct velocity measurements for insight into the flow within the test rooms and to take photos representative of the handler's orientation.

   o Item #6 states in part that "the small sample size by itself does not create statistical limitations" and that "a notable exception is for the dermal exposure summary statistics for scenario 1a, pouring into spray bottles" (Leighton and Cohen, EPA Science Review, 2012, 46).   The implication is that the large relative accuracy for this latter scenario is due to its small sample size.  The Board suggested two alternative causes for the large relative accuracy of scenario 1a (i.e., an fRA (fold relative accuracy) of 3.6 for the spray bottle).

         * The first alternative suggestion relates to the very narrow range of AaiH values engendered by not anticipating within the original protocol a desire to isolate a unit exposure value for the pouring task using a measuring cup.  The range of the six AaiHs while pouring into spray bottles via measuring cups was only 1.3x (ratio of highest to lowest), i.e., the amounts handled were virtually the same.  In contrast, the range of AaiHs was 6.9x for the AaiH of all other conventional pours and 4.2x for all other reduced splash pours.  Thus, even if the sample size had been three or four times larger, the ex post facto study design for spray bottles had very limited power to obtain an fRA within 3-fold.

         * The second alternative cause for the large relative accuracy of the spray bottle scenario relates to a key concept for unit exposure values within such studies.  When the concentration of the active ingredient (ai) within the test material that each ME was handling is similar or virtually equal (as in this study and virtually all other studies of this nature), a range of AaiHs could only have been achieved by varying the volume of test material that each ME handled, and handling a larger volume generally would require a longer handling time.  Thus, an implicit (but unstated) assumption when expecting to find a correlation between AaiH and exposure to test materials of nearly equal concentration is that the exposure rate is constant throughout the handling time.  At least two of the previous comments herein (viz., changes in work practices and in the accumulation of drips and spills) suggest that such an assumption is invalid within this study.  Thus, the high fRA could simply be the result of changes in the individual handlers' rates of exposure over the duration of the exposure time.

   o The first part of item #7 describes the Agency's desire to continue using exposures normalized by AaiH as a default condition despite the results herein in which dermal exposures are not proportional with AaiH (Leighton and Cohen, EPA Science Review, 2012, 47).   The Board concurs with the scientific validity of extrapolating unit exposure values on the basis of concentration and points out that the lack of "log-log linearity" of exposure with AaiH based on handling different volumes of the same concentration of test material (as shown by studies such as this completed study) should not be taken as evidence that weakens the applicability of unit exposures to extrapolate on the basis of different concentrations within the test material.

The Agency asserts that, since regulation occurs at high AaiH, use of an estimator that under-predicts exposure at low AaiH and over-predicts exposure at high AaiH is conservative (Leighton and Cohen, EPA Science Review, 2012, 47).   However, it is not clear whether this linear default assumption will only be applied at high usage.  The adopted unit exposures might in the future be applied in non-occupational scenarios.  The lowest threshold (breakpoint between under- and over-prediction) is on the order of 0.004 pounds ai handled for the spray bottle filling case (Leighton and Cohen, EPA Science Review, 40 [Figure 8]).  At 0.19% solution strength, this represents a little more than 32 ounces of stock solution.  Since a non-occupational spray bottle filling scenario would be very unlikely to ever involve the use of that much stock solution, all applications of the unit exposures in non-occupational settings could be expected to lead to under-prediction of exposure.  The Board recommends that the Agency insert language to preclude default non-conservatism in non-occupational settings.

   o Item #7 also states that "The study could not be designed to vary the concentration of ai to further investigate this assumption because higher concentrations of ai would require the use of chemical resistant gloves" (Leighton and Cohen, EPA Science Review, 2012, 47).   In the Board's review of the protocol (HSRB, October 2011 Meeting Report, 11), it agreed with that statement.  However, with the results now in hand, this rationale is no longer completely valid.  We now know that the hand doses while pouring are so high that the concentration could be reduced by at least 10x, perhaps up to 100x, and still yield consistently measurable exposures on the hands.  Thus, in the event that more exposure data when filling spray bottles is desired at some time in the future, the concentration could easily be lowered to increase the range of AaiH values independent of handling time.

   o Concerns were raised about lumping of hand and non-hand exposures for reasons over and above statistical dissimilarities between the respective data sets.  EPA has traditionally assumed that a fixed fraction of material reaching the skin will be absorbed; however, the Board asserts that this is a very poor assumption.  Absorption varies with both loading conditions and time of exposure.  Hands are subject to higher gross loads and more frequent washing than are other body parts.  Current domination of dermal exposure by the hands might be partially mitigated if absorbed doses were calculated separately.

      2.    Technical issues

The Board identified two technical issues for the Agency to consider.  These relate to the inhalation data and may not have a substantial impact on the study's overall outcome.

         o       A statement in item #8 that pouring comprises a "relatively low aerosol generating application" (Leighton and Cohen, EPA Science Review, 2012, 47) may be true, but it overlooks a potentially useful aspect of the AEATF inhalation data.  Specifically, the AEATF data contains evidence that filling containers without using a measuring cup may have generated enough aerosols to explain the differences between airborne exposures while pouring from CP containers versus pouring from RS containers; such differences were not seen while filling spray bottles.  Both the differences of nearly 4x in the inhalation unit concentration values (0.015 / 0.0044 mg/m[3]/lb ai) and over 4x in concentration without accounting for AaiH (3.5 / 0.82 μg/m[3]) (Leighton and Cohen, EPA Science Review, 2012, 27) were significantly different from 1 at p ≈ 0.01 in t-tests conducted by a Board member.  The difference between CP and RS containers observed in the manual pouring scenario may be attributable to aerosols formed either from the "glugs" or/and from the fall of the liquid impacting on a surface inside the receiving container.  However, because of the small doses via the inhalation route relative to the dermal route, these differences had virtually no impact in the overall results.

         o       The respiration rate of 1 m[3]/hr = 16.7 L/min (Leighton and Cohen, EPA Science Review, 2012, 3 and 22) is potentially too low for Groups 2 and 3 within this scenario by as much as 60%.   Just the liquid alone in the largest containers handled by Group 2 weighed over 16 lbs; and the liquid in the 5 gallon containers in Group 3 weighed 41 lbs.  Pouring multiple containers weighing this much often within 3 to 17 minutes implies a metabolic work rate beyond "light."  If Group 3 were classified as "moderate," their inhalation rates would be 1.6 m[3]/hr for males and females combined, as shown in a recent EPA handbook (EPA, ORD. Exposure Factors Handbook, 2011, pp. 6-4 to 6-6 [Table 6-2]).

      3.    Statistical analysis
      The statistical analysis of the data for this scenario raises some concerns that limit the study's utility.  Five specific areas should be addressed: imputation, the arithmetic mean, q-q plots, non-constant variances, and slopes outside the range [0, 1].  An additional concern is the presentation of numerous analyses, none of which adequately represent the true design of the study.  Some of the results are concerning.  However, if the issues arising from the statistical analysis are fully addressed, some of the Board's concerns might be removed.
   o All methods associated with imputation should be reviewed.  The need for imputation results from a response falling below the detection limit.  Although 0, half the detection limit and the detection limit are common approaches to imputation, maximum likelihood estimation is widely recognized as a better approach (Helsel, Nondetects and Data Analysis, 2005).  The HSRB commends the Agency for moving in this direction. The correlation structure induced by having each worker pour from both a conventional and a reduced-splash container, as well as multiple exposure measurements taken at the time of each event, is particularly noteworthy.  However, the purpose of generating five sets is to reflect the variability in the possible responses falling below the detection limit.  If a single value is imputed, then the analysis reflects the variability in the data, but it fails to reflect the additional uncertainty associated with imputing a value. Consequently, the measures of variance would be biased toward zero.  By averaging the five imputed values for each non-detect, as was done in the analysis of this completed study, the imputed values have less variability than the individual values, leading to a more biased variance than would have been the case had a single value been imputed.  The Board recommends that the analysis use the five sets of values to fully capture the variability.  Conduct an analysis for each data set, and average the results, with the exception of the variance.  The variance is the pooled estimate of the within dataset variation plus the variation among the imputed values.  The standard error is then the square root of the variance (Rubin, Multiple Imputation for Nonresponse in Surveys, John Wiley & Sons, 1987).

         o       In Appendix A of EPA's Science Review, the association between the geometric mean and the arithmetic mean is discussed (Leighton and Cohen, EPA Science Review, 2012, Appendix A, 36).  In the derivation, it is incorrectly assumed that the errors are constant.  Both the pounds of active ingredient (ai) and the error differ with each observation, unlike the intercept and slope, which are constants.  A Taylor series expansion could be used to derive an approximate relationship between the two.  However, the derivation of which the Board members are aware does not consider the more complex setting involving a variance component, much less the two that are presented in this study (one for worker and one for the error of the model).  It is not clear that the same association between the geometric mean and arithmetic mean would hold for this more complex model.  This should be carefully considered and the approach justified or an appropriate reference given.

Even if the association between the geometric mean and the arithmetic mean can be determined for this setting, the Board questions whether the arithmetic mean has value.  Identifying the center of the distribution of values is the key issue.  Sometimes the arithmetic mean provides the best estimate of the center, sometimes the median provides the best estimate of the center, and sometimes the geometric mean provides the best estimate of the center.  The HSRB believes that, for these kinds of studies, geometric means provide the best estimates of the centers of the distributions being sampled.  Furthermore, when a logarithmic transformation is used so that the assumptions associated with linear regression are more nearly met, as is the case here, a geometric mean is widely considered a better measure of the center of the distribution.  The 95[th] percentile of the distribution, which is another metric of interest, allows an assessment of the extreme values.  While it is true that the arithmetic mean is the most commonly used measure of the center of a distribution, it is not as appropriate here.  The Agency should consider carefully what additional information, if any, it is providing.  If only the geometric mean and the 95[th] percentile of the distribution are needed, then confidence intervals can be established on the log-log scale, and the endpoints back-transformed to obtain confidence intervals in the original scale.

         o       The use of q-q (or quantile-quantile) plots is a good approach for assessing the validity of the assumption of normality of the residuals.  In Figure 1, the q-q plot is for the response and not the residuals (Leighton and Cohen, EPA Science Review, 2012, Appendix A, 28).  This causes problems because the mean is not constant, but instead differs with the group.  In addition, there are two, not one, variance components, each of which is assumed to be normally distributed with a mean of 0 but different variances.  Thus, the q-q plots presented are not for a single distribution but, instead, for a mixture of distributions with differing means and variances.

         o       The variances quite clearly differed with the group (bottle, CP and RS containers).  Although this is discussed, the primary analysis does not seem to account for differences in variances, which require the weight statement in SAS's Mixed procedure.  Once the within-group variances have been found to be significantly different, all analyses moving forward should account for those differences.

The proper analysis is a mixed model analysis with subsamples and unequal variances.  Based on the documents and SAS code provided, it is not evident that this is the final model being used.

         o       The estimated slope was negative for all dermal exposure scenarios, although in no case was the slope significantly different from zero.  This raised concerns because it is expected that exposure will increase as the amount of active ingredient handled increases, and a slope of zero implies that the exposure is independent of the amount handled.  Yet, this is the second study for which this concern has arisen.  When the Board considered closed cabs, the accidental exposure from touching contaminated surfaces led to a constant exposure (HSRB Meeting Report, January 2011, 21).  In this completed liquid pour study, spills on the hands resulted in approximately constant exposure.  Although it is true that one cannot conclude that either the slope is negative or zero, one can also not conclude it is greater than zero from these data.  Elsewhere in the report of the completed study, reasons that the slope may truly be negative are explored (Leighton and Cohen, Science Review, 2012, pp.35 and 47).  If, after considering these, it is determined that the slope should not be negative, perhaps consideration should be given to analyzing the exposure to the hands separately from exposure to the rest of the body.  For the hands, exposure being independent of AaiH may be reasonable because the primary exposure is from accidental actions.  For the rest of the body, the assumption of proportionality may be reasonable.

A similar concern should be addressed when estimated slopes are greater than one.  A principled approach to handling these cases should be adopted.

         o       Finally, numerous analyses are presented.  One analysis is based on simple random sampling, but the design was not one of simple random sampling.  Another analysis ignored the correlation of observations from the same worker.  No analysis reflected the true design of the study, which includes clusters of MEs, variability due to workers, group associated with the type of container, and subsamples from the same worker.  For some analyses, means were allowed to differ with group, but not in others.  For some, variances were allowed to differ, but not in the primary analysis.  It is important to consider competing models and to make readers aware that these alternatives were considered. However, in the end, it should be clear which model was used and why.  For this scenario, it is important to account for the correlation among observations from the same worker, to account for differences in the means, to allow for different variances, and to justify failure to account for variation due to clusters of MEs.  Enough should be presented to show when a model has been simplified or additional complexity is presented.  Adding full analyses that are later found not to be appropriate makes the document more challenging to read and may lead to the use of an inappropriate model.
Ethics

Charge to the Board

   * Does available information support a determination that the study was conducted in substantial compliance with subparts K and L of 40 CFR Part 26?

Board Response to the Charge

HSRB Recommendation

   * The Board concurred with the Agency's assessment (Leighton, Cohen, October, 9 2012; Sherman, October, 9 2012) that the proposed research is likely to meet the applicable requirements of 40 CFR part 26, subparts K and L.

HSRB Detailed Recommendations and Rationale
      The Board concurred with the ethics analysis of the proposed study, as detailed in the EPA's Ethics Review (Sherman, EPA Ethics Review, 2012) and summarized briefly below.

      1. Societal Value of Proposed Research

        o The purpose of the completed monitoring study was to determine potential dermal and inhalation exposures to occupational workers and consumers associated with the manual pouring of liquid antimicrobial products.
        o Because many consumers and workers pour antimicrobial products, the research question was important; it could not be answered with confidence without new monitoring data meeting contemporary standards of quality and reliability.

      2. Subject Selection

        o The inclusion/exclusion criteria were complete and appropriate.
        o Pregnant or nursing women were excluded from participation.
        o Employees or relatives of employees of the investigators and of cleaning product manufacturers were also excluded from participation. (One subject was deemed ineligible because he was the spouse of an employee of Ricerca Biosciences LLC, the facility where the research was conducted.)
        o Protections were adequate.
        o Recruitment materials and interactions with potential subjects were language-appropriate.
        o Subjects were recruited through newspaper advertisements, not through employers, which minimized the potential for coercion or undue influence.

      3. Risks to Subjects

        o The proposed test materials were EPA-registered for the use proposed, were of low toxicity to mammals, and were used in full compliance with the approved labels.
        o All identified risks were characterized as of low probability.
        o Risks were minimized by exclusion of candidates known to be sensitive to quaternary ammonium compounds or in poor health or with broken skin on hands, face, or neck; testing in a controlled-temperature environment; alerting subjects to signs and symptoms of heat stress; monitoring heat index with associated stopping rules; allowing subjects to rest whenever they want or need to; close observation of subjects; training of experienced technicians to minimize embarrassment; incorporation of procedures to keep results of pregnancy testing private and to permit discrete withdrawal; provision of appropriate work clothing and PPE.
        o There were no reported or reserved adverse reactions.

      4. Benefits

        o This research offered no direct benefits to the subjects.
        o The research is likely to provide reliable data about the dermal and inhalation exposure of people pouring liquid antimicrobial products from conventional and reduced-splash containers.
        o These data can likely be used by EPA and other regulatory agencies to support exposure assessments for a wide variety of antimicrobial products and their uses.

      5. Risk/Benefit Balance

        o Risks to subjects were thoughtfully and thoroughly minimized in the design of the research.
        o The low residual risk was reasonable, in light of the likely benefits to society from new data supporting more accurate exposure assessments for antimicrobial products.

      6. Independent Ethics Review

        o The proposed research was reviewed and approved by the Independent Investigational Review Board, Inc., (IIRB) of Plantation Florida.
        o The submitted materials included a full record of correspondence between the investigators and the IIRB.

      7. Informed Consent
        o Informed consent was obtained from each prospective subject and appropriately documented in the language preferred by the subject.
        o The proposed monetary compensation was not so high as to unduly influence participation.

      8. Respect for Subjects

        o Subject-identifying information was recorded only once; all subsequent data records and reports refer to individual subjects only by a randomly selected code.
        o Provision was made for discrete handling of the pregnancy testing required of female subjects on the day of testing.
        o Candidates and subjects were free to decline to participate or to withdraw at any time for any reason, without penalty.
References

Cohen, J. Liquid Pour AEATF Study Statistical Review for HSRB. (Appendix A of Leighton T., and J. Cohen. 2012. Science Review of the AEATF II Liquid Pour Human Exposure Monitoring Study.)  Dated October 3, 2012. Unpublished document prepared by the Office of Pesticide Programs, United States Environmental Protection Agency.  16 p.
U.S. Environmental Protection Agency (EPA) Human Studies Review Board (HSRB).  January 26, 2011 EPA Human Studies Review Board Meeting Report. EPA-HSRB-11-01.  Dated March 17, 2011. 24 p.

EPA HSRB. October 19-20, 2011 HSRB Meeting Report. EPA-HSRB-11-03. Dated January 11, 2012. 36 p.
EPA, Office of Air Quality Planning and Standards. 1995. Compilation of Air Pollutant Emission Factors, Volume 1: Stationary Point and Area Sources, Fifth Edition, AP 42, Section 5.2 "Transportation And Marketing Of Petroleum Liquids," Available online at http://www.epa.gov/ttn/chief/ap42/ch05/final/c05s02.pdf
EPA, Office of Research and Development. 2011.  Exposure Factors Handbook: 2011 Edition, EPA/600/R-09/052F.
Helsel, D. R. 2005. Nondetects and Data Analysis: Statistics for Censored Environmental Data. Wiley-Interscience.
Leighton, T. and J. Cohen. 2012. Science Review of the AEATF II Liquid Pour Human Exposure Monitoring Study. Dated October 9, 2012. Unpublished document prepared by the Office of Pesticide Programs, United States Environmental Protection Agency. 50 p.
Rosenheck, L. Final Report: A Study for Measurement of Potential Dermal and Inhalation Exposure During Manual Pouring of a Liquid Containing an Antimicrobial (AEA-05). Dated August 17, 2012. Unpublished document prepared by the Office of Pesticide Programs, United States Environmental Protection Agency. 1127 p.

Rubin, D. B. 1987. Multiple Imputation for Nonresponse in Surveys. John Wiley & Sons: New York.

Sherman, K. 2012. Ethics Review of Completed AEATF II Study for Measurement of Potential
      Dermal and Inhalation Exposure during Manual Pouring of a Liquid Containing an Antimicrobial. Dated October 9, 2012. Unpublished document prepared by the Office of Pesticide Programs, United States Environmental Protection Agency. 16 p.


[Federal Register Volume 78, Number 183 (Friday, September 20, 2013)]
[Notices]
[Pages 57907-57909]
[FR Doc No: 2013-22881]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70417; File No. SR-ISE-2013-48]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend Rule 604, Continuing Education for Registered Persons,
and To Adopt a Corresponding Fee

September 16, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 13, 2013, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change as
described in Items I and II below, which items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange is proposing to amend Rule 604 to clarify the current
continuing education requirements for registered persons based upon
their registration with the Exchange, and to adopt a new continuing
education requirement for Series 56 registered persons, including a
corresponding fee.
    The text of the proposed rule change is available on the Exchange's
Internet Web site at http://www.ise.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The 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 purpose of the proposed rule change is to clarify the current
continuing education requirements for registered persons based upon
their registration with the Exchange, and to adopt a new continuing
education requirement for Series 56 registered persons (``Proprietary
Traders''). The Exchange also proposes to adopt a fee for the new
continuing education program applicable to Proprietary Traders.
    The Exchange adopted the Proprietary Trader registration in 2011,
working with various other exchanges and the Financial Industry
Regulatory Authority (``FINRA''). At this time, the Exchange is
proposing a new Proprietary Trader continuing education program which
will be administered by FINRA. The new program, the S501, is intended
to address the specific continuing education of Proprietary Traders,
based on the content outline for the Series 56 exam, which covers the
main categories of rules and regulations generally applicable to such
persons.\3\
---------------------------------------------------------------------------

    \3\ These generally include recordkeeping and recording
requirements, types and characteristics of securities and
investments, trading practices and display execution and trading
systems. See Securities Exchange Act Release No. 65054 (Aug. 8,
2011), 76 FR 50277 (Aug. 12, 2011) (SR-ISE-2011-36).
---------------------------------------------------------------------------

    The S501 is required for persons who are registered as Proprietary
Traders and do not maintain any other registration. Individuals that
are registered under any other registration are required to maintain
the continuing educations [sic] obligations associated with such
registrations. For example, an individual that engages solely in
proprietary trading activities but has passed the Series 7 and is
registered as a General Securities Representative will be required to
continue taking the Series 7 continuing education program (S101).
Although such an individual may be engaging in the same activities as
an individual registered as a Proprietary Trader, the Series 7
examination is more comprehensive and covers topics that the Series 56
does not. Thus, the Exchange believes that this individual should
complete the continuing education associated with the Series 7 because
this covers all aspects of the individual's registration.
    The introduction of the S501 allows the Exchange to tailor its
continuing education requirements more closely to the duties of
individuals who have registered with the Exchange as Proprietary
Traders after passing the Series 56. More specifically, the Exchange
believes allowing individuals engaging solely in proprietary trading
who take the Series 56 and register as Proprietary Traders to complete
a separate continuing education program than those Proprietary Traders
who passed the Series 7 and maintain a General Securities
Representative registration is appropriate given that all individuals
who engage solely in proprietary trading have the option of taking
either test. In comparison to the more comprehensive Series 7, the
Series 56 examination is more closely tailored to the practice of
proprietary trading. As such, the Exchange believes a Series 56
continuing education program should be tailored as well. At the same
time, if an individual who has passed the Series 7 would like to retain
a General Securities Representative registration, the Exchange believes
it is appropriate they [sic] continue to be required to complete the
broader continuing education program, which covers all aspects of this
registration.
    The Exchange also proposes to amend Rule 604(a) to specify the
required Regulatory Element for each category of registered persons.
Currently, Rule 604(a) provides that no Member shall permit any
registered person to continue to, and no registered person shall
continue to, perform duties as a registered person, unless such person
has complied with the continuing education requirements of paragraph
(a). Each registered person shall complete the Regulatory Element of
the continuing education program on the occurrence of their [sic]
second registration anniversary date(s), and every three years
thereafter or as otherwise prescribed by the Exchange. On each
occasion, the Regulatory

Element must be completed within 120 days after the person's
registration anniversary date. A person's initial registration date,
also known as the ``base date,'' shall establish the cycle of
anniversary dates for purposes of this Rule. This applies to persons
registered as Proprietary Traders as well.
    The Rule further provides that the content of the Regulatory
Element of the program shall be determined by the Exchange for each
registration category of persons subject to the Rule. The Exchange now
proposes to make clear which specific programs are required, including
both existing programs (S101 and S201) as well as the new Proprietary
Trader continuing education program (S501). The following Regulatory
Elements administered by FINRA shall be required:
    The S201 Supervisor Program for registered principals and
supervisors;
    The S501 Series 56 Proprietary Trader Continuing Education Program
for Series 56 registered persons; and
    The S101 General Program for Series 7 and all other registered
persons.
    The Exchange believes that specifying the applicable Regulatory
Element in the Rule should be helpful to Members in complying with the
Rule. Only one Regulatory Element is required. For example, members
registered as supervisors are subject to the S201 only; they do not
also have to complete the Regulatory Element applicable to their
prerequisite registration, such as the S501 or the S101.\4\ This
proposal does not change the registration requirements.
---------------------------------------------------------------------------

    \4\ As stated above, in the event that a person is registered
both as a Proprietary Trader (Series 56) and a General Securities
Representative (Series 7), only one Regulatory Element is required--
the ``higher'' of the two, which is the S101.
---------------------------------------------------------------------------

    The Exchange also proposes to adopt a $60 fee for the S501
continuing education program, which will be used for the administration
of the S501. FINRA administers this program on behalf of the exchanges
and therefore the fees are payable directly to FINRA.\5\ The Exchange
expects that the exchanges that recognize the Proprietary Trader
registration either have or will adopt the same fee for continuing
education.
---------------------------------------------------------------------------

    \5\ The S501 was established for those registrants who have
passed the Series 56 Qualification Exam as reflected in WebCRD.
WebCRD is the central licensing and registration system for the U.S.
securities industry. The CRD system enables individuals and firms
seeking registration with multiple states and self-regulatory
organizations to do so by submitting a single form, fingerprint card
and a combined payment of fees to FINRA. Through the CRD system,
FINRA maintains the qualification, employment and disciplinary
histories of registered associated persons of broker-dealers.
---------------------------------------------------------------------------

    The Exchange's Schedule of Fees does not currently set forth the
session fees for other continuing education programs required by the
Exchange because these programs are within the jurisdiction of the
Financial Industry Regulatory Authority (``FINRA''), which collects
these session fees from its members. The Series 56, however, applies to
ISE Members that are not required by Section 15(b)(8) \6\ of the Act to
become members of FINRA. Therefore, the Exchange believes it is
appropriate to include the Series 56 continuing education fee within
the Exchange's Schedule of Fees to make the cost of this program clear
to ISE Members.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78o(b)(8).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \7\ in general, and furthers the objectives of: (1)
Section 6(c)(3)(B) of the Act,\8\ pursuant to which a national
securities exchange prescribes standards of training, experience and
competence for members and their associated persons; and (2) Section
6(b)(5) of the Act,\9\ in that it is designed, among other things, to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, to protect investors and the public interest, by
requiring registered persons to complete the applicable continuing
education program. The Exchange believes that a strong continuing
education program should bolster the integrity of the Exchange by
helping to ensure that all associated persons engaged in a securities
business are, and will continue to be, properly trained and qualified
to perform their functions.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78(c)(3)(B).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange does not believe that the proposal is unfairly
discriminatory with respect to persons registered as a General
Securities Representative who function in their current job as a
Proprietary Trader, even though these persons are subject to the more
stringent S101 rather than the S501. Such persons are registered and
qualified (Series 7) in a ``higher'' capacity and are therefore
qualified to function in a capacity other than a Proprietary Trader,
whether they choose to or not. Accordingly, requiring the S101 for such
persons is appropriate and facilitates them being able to maintain
their ``higher'' registration. Moreover, the Exchange believes that
permitting General Securities Representatives functioning as
Proprietary Traders to complete the S501 would be confusing and
difficult to monitor.
    The Exchange also believes that the proposal furthers the
objectives of Section 6(b)(4) of the Act,\10\ in that it provides for
an equitable allocation of reasonable fees and other charges among
Exchange Members and other persons using its facilities. The proposed
fee is equitable, because it applies equally to all persons registered
solely as Proprietary Traders. The Exchange notes that it will not
invoice or collect funds from Members that are subject to these fees
because these fees will be paid directly to FINRA as administrator of
the continuing education program. The proposed fees are reasonably
designed to allow FINRA to cover its cost of administering the Series
56 continuing education program on behalf of the Exchange, and the
Exchange believes it is reasonable and equitable to include these fees
in its Schedule of Fees to make the costs of the Series 56 continuing
education requirement clear to Members. Moreover, the Exchange believes
other exchanges will be assessing the same fees for this continuing
education program.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. All Proprietary Traders,
regardless of where they are registered, will be subject to same
continuing education requirements and fees. Thus, the proposal treats
similarly situated persons in the same way. In addition, all of the
exchanges that recognize the Proprietary Trader registration category
are expected to adopt the same continuing education requirements \11\
and fee.\12\
---------------------------------------------------------------------------

    \11\ See e.g. Securities Exchange Act Release Nos. 70237 (Aug.
20, 2013), 78 FR 52814 (Aug. 26, 2013) (SR-BATS-2013-046); 70027
(July 23, 2013), 78 FR 45584 (July 29, 2013) (SR-CBOE-2013-076);
70327 (Sept. 5, 2013), 78 FR 55766 (Sept. 11, 2013) (SR-Phlx-2013-
85).
    \12\ See e.g. Securities Exchange Act Release Nos. 70257 (Aug.
26, 2013), 78 FR 53814 (Aug. 30, 2013) (SR-BATS-2013-047); 70064
(July 30, 2013), 78 FR 47469 (Aug. 5, 2013) (SR-CBOE-2013-078);
70194 (Aug. 14, 2013) 78 FR 51259 (Aug. 20, 2013) (SR-C2-2013-030);
70327 (Sept. 5, 2013), 78 FR 55766 (Sept. 11, 2013) (SR-Phlx-2013-
85).
---------------------------------------------------------------------------

    The proposed rule change will merely align Exchange Rules with
those of other exchanges. The Exchange does not believe that these
proposed rule changes

will affect intermarket competition because the Exchange believes that
all exchanges that impose the same continuing education requirements
will file similar rule changes addressing these continuing education
programs. Furthermore, the Exchange does not believe the proposed
change will affect intramarket competition because all similarly
situated registered persons (e.g. registered persons maintaining the
same registrations) are required to complete the same continuing
education requirements. For example, all individuals maintaining a
Series 7 registration as a General Securities Representative will be
required to complete the S101 continuing education program, while all
individuals maintaining a Series 56 registration (and no other
registrations) will be required to complete the new S501 continuing
education program.

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

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

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

    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, the proposed rule
change has become effective pursuant to Section 19(b)(3)(A) of the Act
\13\ and Rule 19b-4(f)(6) thereunder.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay. The proposed rule change specifies the continuing
education requirements that currently apply to registered persons, and
adopts a continuing education requirement, the S501, and a related fee
for persons registered as Proprietary Traders. Waiver of the operative
delay would allow the Exchange to clarify its rules and implement the
proposed rule change at once, enabling its members to clearly
understand which continuing education program applies to their
registered persons and to comply with the continuing education
requirements in a timely manner, and thus is consistent with the
protection of investors and the public interest. Therefore, the
Commission designates the proposal operative upon filing.\14\
---------------------------------------------------------------------------

    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of this proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2013-48 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2013-48. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2013-48 and should be
submitted on or before October 11, 2013.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-22881 Filed 9-19-13; 8:45 am]
BILLING CODE 8011-01-P


quality standard as being due to an exceptional event by placing a flag
in the appropriate field for the data record of concern in accordance
with the schedules for submission of data to the AQS data base in 40
CFR 58.35.
    (ii) Flags placed on data in accordance with this section shall be
deemed informational only, and the data shall not be excluded from
determinations with respect to exceedances or violations of the
national ambient air quality standards unless and until EPA notifies
the State of its concurrence by placing a concurrence flag in the
appropriate field for the data record in the AQS data base.

    (3) Submission of demonstrations. (i) A State that has flagged data
as being due to an exceptional event shall, after notice and
opportunity for public comment, submit a complete demonstration to EPA
in support of its request for exclusion not later than 180 days
following the end of the calendar quarter in which the flagged
concentration was recorded.
    (A) Extensions. Where a State demonstrates to the satisfaction of
EPA that additional time is needed to obtain information or complete
analyses to demonstrate that an exceptional event caused an exceedance
or violation of an ambient air quality standard, and that such
information is likely to have significant probative value, then EPA may
grant an extension of the date for submission of demonstrations of not
more than an additional 90 days.
    (B) [Reserved]
    (ii) [Reserved]
    (4) EPA review and concurrence or nonconcurrence. (i) EPA shall
complete its review and concur or nonconcur with a State's request for
exclusion not later than 30 days following receipt of a complete
submission from the State. EPA shall notify the State of its
concurrence or nonconcurrence by placing a flag in the appropriate
field for the data record in the AQS data base.
    (A) Extensions. Where additional time is needed to complete its
review of the State's demonstration, EPA may extend the time for review
by not more than an additional 30 days.
    (B) [Reserved]
    (ii) [Reserved]
    OPTION 2 for paragraphs (c)(2) through (c)(4):
    (2) Flagging of data. (i) A State shall notify EPA of its intent to
exclude one or more measured exceedances of an applicable ambient air
quality standard as being due to an exceptional event by placing a flag
in the appropriate field for the data record of concern in accordance
with the schedules for submission of data to the AQS data base in 40
CFR 58.35.
    (ii) Flags placed on data in accordance with this section shall be
deemed informational only, and the data shall not be excluded from
determinations with respect to exceedances or violations of the
national ambient air quality standards unless and until EPA notifies
the State of its concurrence by placing a concurrence flag in the
appropriate field for the data record in the AQS data base.
    (3) Submission of demonstrations. (i) A State that has flagged data
as being due to an exceptional event shall, after notice and
opportunity for public comment, submit a complete demonstration to EPA
in support of its request for exclusion not later than 3 years
following the end of the calendar quarter in which the flagged
concentration was recorded.
    (ii) [Reserved]
    (4) EPA review and concurrence or nonconcurrence. (i) EPA shall
complete its review and concur or nonconcur with a State's request for
exclusion not later than 30 days following receipt of a complete
submission from the State. EPA shall notify the State of its
concurrence or nonconcurrence by placing a flag in the appropriate
field for the data record in the AQS data base.
    (A) Extensions. Where additional time is needed to complete its
review of the State's demonstration, EPA may extend the time for review
by not more than an additional 30 days.
    (B) [Reserved]
    (ii) [Reserved]
    OPTION 3 for paragraphs (c)(2) through (c)(4):
    (2) Flagging of data. (i) A State shall notify EPA of its intent to
exclude one or more measured exceedances of an applicable ambient air
quality standard as being due to an exceptional event by placing a flag
in the appropriate field for the data record of concern not later than
180 days prior to the date on which EPA intends to propose
determinations with respect to violations of applicable national
ambient air quality standards.
    (ii) Flags placed on data in accordance with this section shall be
deemed informational only, and the data shall not be excluded from
determinations with respect to exceedances or violations of the
national ambient air quality standards unless and until EPA notifies
the State of its concurrence by placing a concurrence flag in the
appropriate field for the data record in the AQS data base.
    (3) Submission of demonstrations. (i) A State that has flagged data
as being due to an exceptional event shall, after notice and
opportunity for public comment, submit a complete demonstration to EPA
in support of its request for exclusion not later than 180 days prior
to the date on which EPA intends to propose determinations with respect
to violations of applicable national ambient air quality standards.
    (ii) [Reserved]
    (4) EPA review and concurrence or nonconcurrence. (i) EPA shall
complete its review and concur or nonconcur with a State's request for
exclusion not later than 30 days following receipt of a complete
submission from the State. EPA shall notify the State of its
concurrence or nonconcurrence by placing a flag in the appropriate
field for the data record in the AQS data base.
    (A) Extensions. Where additional time is needed to complete its
review of the State's demonstration, EPA may extend the time for review
by not more than an additional 30 days.
    (B) [Reserved]
    (ii) [Reserved]

PART 51--NATIONAL PRIMARY AND SECONDARY NATIONAL AMBIENT AIR
QUALITY STANDARDS

    1. The authority citation for part 51 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

    2. Add Subpart Y consisting of Sec.  51.920 to read as follows:

Subpart Y--Exceptional Events

    OPTION 1 for Sec.  51.920:

Sec.  51.920  Mitigation of exceptional events.

    (a) As a condition for EPA's approval of a request to exclude air
quality data due to exceptional events from use, each State must take
appropriate and reasonable actions to protect public health from
exceedances or violations of the national ambient air quality standards
due to exceptional events. The State must:
    (1) Provide for prompt public notification whenever air quality
concentrations exceed or are expected to exceed an applicable ambient
air quality standard.
    (2) Provide for public education concerning actions that
individuals may take to reduce exposures to unhealthy levels of air
quality during and following an exceptional event.
    (3) Provide for the implementation of reasonable measures to
protect public health from exceedances or violations of ambient air
quality standards caused by exceptional events.
    (a) [Reserved]
    OPTION 2 for Sec.  51.920:

Sec.  51.920  Mitigation of exceptional events.

    (a) As a condition for EPA's approval of a request to exclude air
quality data due to exceptional events from use, each plan must include
a mitigation action plan which provides for appropriate actions to
protect public health from exceedances or violations of the national
ambient air quality standards due to exceptional events. Each
mitigation action plan must:
    (1) Provide for prompt public notification whenever air quality
concentrations exceed or are expected to exceed an applicable ambient
air quality standard.
    (2) Provide for public education concerning actions that
individuals may take to reduce exposures to unhealthy

levels of air quality during and following an exceptional event.
    (3) Describe the procedures by which appropriate actions will be
identified and taken to prevent or mitigate public health threats
associated with exceptional events.
    (4) Provide for the implementation of reasonably available control
measures to reduce emissions from those anthropogenic sources which are
not exempt under Sec.  50.13(a)(2)(ii) of this chapter and which
interact with recurring natural events to contribute to exceedances or
violations of applicable national ambient air quality standards.
    (b) States should periodically reevaluate mitigation action plans
for adequacy and revise them as necessary and appropriate.
    OPTION 3 for Sec.  51.920:

Sec.  51.920  Mitigation of exceptional events.

    (a) As a condition for EPA's approval of a request to exclude air
quality data due to exceptional events from use in determinations with
respect to exceedances or violations of the national ambient air
quality standards, each State must adopt and implement a mitigation
action plan for an affected area which provides for appropriate actions
to protect public health from exceedances or violations of national
ambient air quality standards due to exceptional events which is to be
implemented in an affected area on an episodic basis. Mitigation action
plans need not be incorporated into the applicable implementation plan,
but each mitigation action plan must:
    (1) Provide for prompt public notification whenever air quality
concentrations exceed or are expected to exceed an applicable ambient
air quality standard.
    (2) Provide for public education concerning actions that
individuals may take to reduce exposures to unhealthy levels of air
quality during and following an exceptional event.
    (3) Describe the procedures by which appropriate actions will be
identified and taken to prevent or mitigate public health threats
associated with exceptional events.
    (4) Provide for the implementation of reasonably available control
measures to reduce emissions from those anthropogenic sources which are
not exempt under Sec.  50.13(a)(2)(ii) of this chapter and which
interact with recurring natural events to contribute to exceedances or
violations of applicable national ambient air quality standards.
    (b) States should periodically reevaluate mitigation action plans
for adequacy and revise them as necessary and appropriate.

[FR Doc. 06-2179 Filed 3-9-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 146 (Tuesday, August 1, 2017)]
[Proposed Rules]
[Pages 35714-35716]
[FR Doc No: 2017-16089]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

Docket No. FAA-2017-0646; Airspace Docket No. 17-AGL-17

Proposed Establishment of Class E Airspace; Ellendale, ND

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace at
Ellendale, ND. Controlled airspace is necessary to accommodate new
special Instrument Approach Procedures developed at Ellendale Municipal
Airport, for the safety and management of instrument flight rules (IFR)
operations at the airport.

DATES: Comments must be received on or before September 15, 2017.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2017-0646; Airspace Docket No. 17-AGL-17, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and

subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX, 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. 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 the use of
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 establish Class E airspace extending up to and including
700 feet above the surface at Ellendale Municipal Airport, Ellendale,
ND, to support special instrument approach procedures for IFR
operations at the airport.

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 and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2017-0646/
Airspace Docket No. 17-AGL-17.'' The postcard will be date/time stamped
and returned to the commenter.

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/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 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX, 76177.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by establishing Class E airspace extending
upward from 700 feet above the surface within a 6.3-mile radius of
Ellendale Municipal Airport, Ellendale, ND, to accommodate new special
instrument approach procedures. Controlled airspace is needed for the
safety and management of IFR operations at the airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    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, is
non-controversial and unlikely to result in adverse or negative
comments. 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. 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.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL ND E5 Ellendale, ND [New]

Ellendale Municipal Airport, ND
    (Lat. 46[deg]00'59'' N., long. 098[deg]30'56'' W.)

That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of Ellendale Municipal Airport.

    Issued in Fort Worth, TX on July 20, 2017.
Walter Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-16089 Filed 7-31-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Pages 71890-71891]
[FR Doc No: 2020-25002]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG21-20-000.
    Applicants: Beowawe Power, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Beowawe Power, LLC.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5071.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: EG21-21-000.
    Applicants: Cameron Ridge, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Cameron Ridge, LLC.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5078.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: EG21-22-000.
    Applicants: Cameron Ridge II, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Cameron Ridge II, LLC.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5096.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: EG21-23-000.
    Applicants: DifWind Farms LTD VI.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of DifWind Farms LTD VI.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5099.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: EG21-24-000.
    Applicants: Terra-Gen Dixie Valley, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Terra-Gen Dixie Valley, LLC.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5100.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: EG21-25-000.
    Applicants: Garnet Wind, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Garnet Wind, LLC.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5103.
    Comments Due: 5 p.m. ET 11/27/20.

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

    Docket Numbers: ER03-1001-003.
    Applicants: Galt Power, Inc.
    Description: Notice of Change in Status of Galt Power, Inc.
    Filed Date: 10/30/20.
    Accession Number: 20201030-5467.
    Comments Due: 5 p.m. ET 11/20/20.

    Docket Numbers: ER17-105-007; ER09-1196-003; ER10-1362-007; ER11-
3959-009; ER12-2639-010; ER12-726-008; ER15-1019-008; ER17-104-007;
ER17-556-005; ER18-2158-002.
    Applicants: Broadview Energy JN, LLC, Broadview Energy KW, LLC,
Grady

Wind Energy Center, LLC, Fowler Ridge IV Wind Farm LLC, Hatchet Ridge
Wind, LLC, Spring Valley Wind LLC, Ocotillo Express LLC, Lost Creek
Wind, LLC, Post Rock Wind Power Project, LLC, Stillwater Wind, LLC.
    Description: Notice of Change in Status of Broadview Energy JN,
LLC, et. al.
    Filed Date: 10/30/20.
    Accession Number: 20201030-5466.
    Comments Due: 5 p.m. ET 11/20/20.

    Docket Numbers: ER19-1781-001.
    Applicants: MeterGenius, Inc.
    Description: Notice of Change in Status of MeterGenius, Inc.
    Filed Date: 10/30/20.
    Accession Number: 20201030-5468.
    Comments Due: 5 p.m. ET 11/20/20.

    Docket Numbers: ER21-317-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA 5845; Queue
No. AF1-300 to be effective 10/7/2020.
    Filed Date: 11/4/20.
    Accession Number: 20201104-5075.
    Comments Due: 5 p.m. ET 11/25/20.

    Docket Numbers: ER21-318-000.
    Applicants: Morgantown Steam, LLC.
    Description: Sec.  205(d) Rate Filing: Supplemental Notice of
Succession to be effective 8/4/2020.
    Filed Date: 11/4/20.
    Accession Number: 20201104-5078.
    Comments Due: 5 p.m. ET 11/25/20.

    Docket Numbers: ER21-319-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA No. 5822; Queue
No. AE1-143 to be effective 10/7/2020.
    Filed Date: 11/4/20.
    Accession Number: 20201104-5085.
    Comments Due: 5 p.m. ET 11/25/20.

    Docket Numbers: ER21-320-000.
    Applicants: San Diego Gas & Electric Company.
    Description: Informational Filing of Transmission Owner Rate
Appendix XII [Cycle 3] of San Diego Gas & Electric Company.
    Filed Date: 10/30/20.
    Accession Number: 20201030-5458.
    Comments Due: 5 p.m. ET 11/20/20.

    Docket Numbers: ER21-322-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 5835; Queue No. AF2-288 to be effective 10/6/2020.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5033.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-323-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA SA No. 5842;
Queue No. AF2-286 to be effective 10/6/2020.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5066.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-324-000.
    Applicants: Public Service Company of New Mexico.
    Description: Compliance filing: Refund Report in response to Audit
in Docket No. PA18-1-000 to be effective N/A.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5070.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-325-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA SA No. 5843;
Queue No. AF2-287 to be effective 10/6/2020.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5072.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-326-000.
    Applicants: Direct Energy Business Marketing, LLC.
    Description: Compliance filing: Report Regarding a Spot Market Sale
of Electric in WECC to be effective N/A.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5091.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-327-000.
    Applicants: Commonwealth Edison Company, PJM Interconnection,
L.L.C.
    Description: Sec.  205(d) Rate Filing: ComEd submits IA No. 5742 to
be effective 10/29/2020.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5097.
    Comments Due: 5 p.m. ET 11/27/20.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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: November 5, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-25002 Filed 11-10-20; 8:45 am]
BILLING CODE 6717-01-P