[Federal Register: September 9, 2008 (Volume 73, Number 175)]
[Notices]
[Page 52352-52353]
[DOCID:fr09se08-79]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8712-4; Docket ID No. EPA-HQ-ORD-2008-0058]

Draft Toxicological Review of Carbon Tetrachloride: In Support of
the Summary Information in the Integrated Risk Information System
(IRIS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Peer Review Workshop.

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SUMMARY: EPA is announcing that Eastern Research Group, Inc. (ERG), an
EPA contractor for external scientific peer review, will convene an
independent panel of experts and organize and conduct an external peer
review workshop to review the external review draft document titled,
``Toxicological Review of Carbon Tetrachloride: In Support of Summary
Information on the Integrated Risk Information System (IRIS)'' (EPA/
635/R-08/005A). EPA previously announced the 60-day public comment
period (ending July 21, 2008) for the draft document in the Federal
Register on May 21, 2008 (73 FR 29502). EPA will consider public
comments and recommendations from the expert panel workshop as EPA
finalizes the draft document.
    The public comment period and the external peer review workshop are
separate processes that provide opportunities for all interested
parties to comment on the document. EPA intends to forward public
comments submitted in accordance with the Federal Register notice (73
FR 29502) to ERG for consideration by the external peer review panel
prior to the workshop.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination.
    The public may attend this workshop as observers through a
registration process, and time will be set aside for observers to give
brief oral comments at the workshop regarding the draft document under
review. The draft document and EPA's peer review charge are available
via the Internet on NCEA's home page under the Recent Additions and the
Data and Publications menus at http://www.epa.gov/ncea. When finalizing
the draft document, EPA intends to consider the comments and
recommendations from the external peer

review workshop and any public comments that EPA receives in accordance
with 73 FR 29502, May 21, 2008. Public comments submitted during the
60-day public comment period ending July 21, 2008 may be observed at
http://www.regulations.gov under Docket ID No. EPA-HQ-ORD-2008-0058.

DATES: The peer review workshop will begin on October 14, 2008, at
approximately 8:30 a.m. and end at approximately 5 p.m., Eastern time.
Observers must register by Tuesday, October 7, 2008. Indicate at the
time of registration if you wish to make brief oral comments at the
workshop.

ADDRESSES: The peer review workshop will be held at the Navy League
Building, 2300 Wilson Blvd, Arlington, Virginia 22201. ERG is
organizing, convening, and conducting the peer review workshop. To
attend the workshop as an observer, register by Tuesday, October 7,
2008, via the Internet at https://www2.ergweb.com/projects/conferences/
peerreview/register-carbontetra.htm. You may also register by e-mail at
<EMAIL_ADDRESS>(subject line: Carbon Tetrachloride Workshop), by
phone:<PHONE_NUMBER> or toll free at<PHONE_NUMBER>, or by faxing a
registration request to<PHONE_NUMBER> (please reference the ``Carbon
Tetrachloride Peer Review Workshop'' and include your name, title,
affiliation, full address and contact information).
    The draft ``Toxicological Review of Carbon Tetrachloride: In
Support of Summary Information on the Integrated Risk Information
System (IRIS)'' is available via the Internet on the National Center
for Environmental Assessment's (NCEA) home page under the Recent
Additions and the Data and Publications menus at http://www.epa.gov/
ncea. A limited number of paper copies are available from NCEA's
Technical Information Staff, telephone:<PHONE_NUMBER>; facsimile: 703-
347-8691. If you are requesting a paper copy, please provide your name,
mailing address, and the document title. Copies are not available from
ERG.

FOR FURTHER INFORMATION CONTACT: For information on the peer review
workshop, contact ERG, 110 Hartwell Avenue, Lexington, MA 02421-3136;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>(subject line: Carbon tetrachloride). If you have
questions about the document, contact Susan Rieth, IRIS Staff, National
Center for Environmental Assessment, (8601P), U.S. EPA, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; telephone: 703-347-
8582; facsimile:<PHONE_NUMBER>; or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Summary of Information About the Integrated Risk Information System
(IRIS)

    IRIS is a database that contains potential adverse human health
effects information that may result from chronic (or lifetime) exposure
to specific chemical substances found in the environment. The database
(available on the Internet at http://www.epa.gov/iris) contains
qualitative and quantitative health effects information for more than
540 chemical substances that may be used to support the first two steps
(hazard identification and dose-response evaluation) of a risk
assessment process. When supported by available data, the database
provides oral reference doses (RfDs) and inhalation reference
concentrations (RfCs) for chronic health effects, and oral slope
factors and inhalation unit risks for carcinogenic effects. Combined
with specific exposure information, government and private entities can
use IRIS data to help characterize public health risks of chemical
substances in a site-specific situation and thereby support risk
management decisions designed to protect public health.

II. Workshop Information

    Members of the public may attend the workshop as observers, and
there will be a limited time for oral comments from the public. Pre-
registration is strongly recommended as space is limited, and
registrations will be accepted on a first-come, first-served basis. The
deadline for pre-registration is October 7, 2008. If space allows,
registrations will continue to be accepted after this date, including
on-site registrations. Time will be set aside to hear comments from
observers, and individuals will be limited to a maximum of five minutes
during the morning session of peer review workshop. Please let ERG know
if you wish to make comments during the workshop by registering on the
Web site at https://www2.ergweb.com/projects/conferences/peerreview/
register-carbontetra.htm and indicating your intent to make oral
comments.

    Dated: August 30, 2008.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. E8-20877 Filed 9-8-08; 8:45 am]

BILLING CODE 6560-50-P


Plan for the Assessment of Detection and Quantitation Limits Under Section 304( h) of the Clean Water Act Draft: December 4, 2001 Version 03 U. S. Environmental Protection Agency Office of Water Office of Science and Technology Acknowledgments This plan was prepared by Charles E. White, Maria Gomez Taylor, Henry D. Kahn, William A. Telliard, and Khouane Ditthavong of the Engineering and Analysis Division in EPA's Office of Water. Harry McCarty with DynCorp I& ET and Dale Rushneck with Interface, Inc. provided assistance under EPA Contract No. 68 C 01 091, and Sidina Dedah with Science Applications International Corporation provided assistance under EPA Contract No. 68 C 99 233.

Questions or comments regarding this plan should be addressed to:

Charles E. White, Statistician Engineering and Analysis Division ( 4303) Office of Science and Technology USEPA Office of Water 1200 Pennsylvania Avenue, NW Washington, DC 20460 White. Charles E@ EPA. Gov Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 1 Plan for the Assessment of Detection and Quantitation Limits Under Section 304( h) of the Clean Water Act Introduction EPA promulgated Method 1631B: Mercury in Water by Oxidation, Purge and Trap, and Cold Vapor Atomic Fluorescence Spectrometry on June 8, 1999 ( 64 FR 30417). The method was developed specifically to measure concentrations of mercury at ambient water quality criteria levels, and includes a method detection limit ( MDL) of 0.2 ng/ L ( ppt). This MDL is approximately 400 times lower than previously approved methods for measurement of mercury.

Following promulgation, a law suit was filed challenging EPA on the validity of the method. The basis of the challenge included several specific aspects of Method 1631 itself as well as the procedures used to establish the specific MDL and minimum level of quantitation ( ML) published in the method.

In order to settle the lawsuit, EPA entered into a settlement agreement with the Alliance of Automobile Manufacturers, Inc., the Chemical Manufacturers Association, and the Utility Water Act Group ( collectively the " Petitioners") and the American Forest and Paper Association (" Intervenor") on October 19, 2000. Clause 6 of the settlement agreement required EPA to:

reassess EPA's method detection limit ( MDL; 40 CFR 136, Appendix B) and minimum level of quantitation ( ML) procedures according to a schedule ;

perform an external peer review of this reassessment,

perform an external peer review of any alternative procedures under consideration; and

propose a revised or alternate procedure, if warranted This document contains the detailed plan for the reassessment called for in Clause 6 and for complying with the schedule specified in the settlement agreement.

Origins of the Office of Water's Detection and Quantitation Concepts Section 304( h) of the Clean Water Act requires that the EPA Administrator " promulgate guidelines establishing test procedures for the analysis of pollutants" to be monitored and regulated under the National Pollutant Discharge Elimination System ( NPDES). To meet the requirements of Section 304( h), EPA proposes and promulgates test methods at 40 CFR part 136. The approved methods have been drawn from a variety of sources, including methods developed by EPA as well as methods from voluntary consensus standards bodies ( VCSBs) such as the American Public Health Association ( APHA) which publishes Standard Methods for the Examination of Water and Wastewater and the American Society for Testing and Materials ( ASTM).

Among considerations for approval of a method at 40 CFR 136 are the demonstrated performance characteristics of precision, bias, and detection and/ or quantitation limit. Among these characteristics, detection and quantitation limits have been the most controversial. Broadly Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 2 speaking, detection refers to the capability of an analytical procedure to identify or indicate the presence of an analyte in a sample. The detection limit is the concentration level at which the determination is made to report that an analyte has been found or " detected" in a sample. Quantitation refers to the capability for measurement of an analyte; that is, associating a measured, numerical value with the concentration of analyte in a sample. The quantitation limit is the lowest concentration at which a quantified, measured value for the amount of an analyte in a sample is reported.

EPA's Method Detection Limit and Minimum Level of Quantitation EPA's Environmental Monitoring and Support Laboratory in Cincinnati, OH ( EMSL Ci), developed a procedure for determining a detection limit, known as the method detection limit ( MDL) as one measure of method performance. The MDL was defined by Glaser et al. in an article in Environmental Science and Technology in 1981 ( ES& T, Vol. 15, No. 12, pp 1426 1435, 1981) as:

"... the minimum concentration of a substance that can be identified, measured, and reported with 99% confidence that the analyte concentration is greater than zero and is determined from replicate analyses of a sample of a given matrix containing analyte."

On October 26, 1984, the MDL procedure was promulgated as Appendix B to 40 CFR part 136. Both the MDL concept and the specific definition at part 136 were widely adopted by other Program Offices within EPA. The MDL has also been used extensively in the environmental analytical chemistry community outside EPA.

Prior to the formal development of the MDL, EPA included the term " minimum level" ( ML) or " minimum level of quantitation" in some gas chromatography/ mass spectrometry ( GC/ MS) methods that were proposed on December 3, 1979, and subsequently promulgated on October 26, 1984. This original definition of the ML did not involve the MDL, but was an effort to recognize the importance of mass spectral identification and calibration in establishing the quantitative performance of GC/ MS procedures. The ML was defined as:

"... the lowest level at which the analytical system shall give recognizable mass spectra ( background corrected) and acceptable calibration points."

In 1994, in response to concerns voiced by both the regulated community and some State regulatory agencies, EPA refined the definition of the ML, relating it to the American Chemical Society's definition of the limit of quantitation ( LOQ), which is defined as 10 times the standard deviation of replicate blank or low concentration measurements ( see Analytical Chemistry Vol. 52, p. 2242, 1980, and Vol. 55, 2210 2218, 1983). Thus, the ML became related to the MDL and was often calculated as 3.18 times the MDL, because the MDL is commonly determined as 3.14 times the standard deviation of 7 replicate measurements and 10 divided by 3.14 equals 3.18. This calculation makes the ML analogous to the ACS LOQ ( i. e., the ML is defined as 10 times the standard deviation used to determine the MDL). Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 3 Organization of this Plan For the purposes of this plan, EPA has identified 16 events or tasks to be completed as part of the assessment of detection and quantitation limits. Each event is summarized, the analytical methodology is discussed, and currently envisioned supporting materials are listed. Each event is indexed to specific requirements in the Settlement Agreement. The schedule for the event is presented graphically on the last page of this plan. [ Assignment information ( STAT, AMT, SASB) will not be included in the version circulated to the public.]

Planned Events Where listed, data sets indicated are those that will be considered in the evaluation. Other data sets may be considered at a later time.

1. Finalize Internal Draft of Detailed Plan The detailed Plan for reassessment of detection and quantitation procedures is developed here. The analytical ( statistical) methodology will address issues suggested in the scientific literature and issues developed in settlement discussions.

2. Agency Workgroup Review of Plan The Agency Workgroup for detection and quantitation will review and comment on this plan. This Agency Workgroup is comprised of measurement analysts and statisticians representing different Offices within EPA. Time and resources allowing, the plan may also be reviewed and commented on by outside reviewers. Comments from these and other sources will be reviewed by the Core Workgroup and the Plan will be revised where appropriate. The Core Workgroup is comprised of measurement analysts and statisticians within the Office of Science and Technology who have primary responsibility for developing and implementing this plan.

3. Issues Development Properties considered for detection/ quantitation estimates are to be developed in relation to the issues listed in this section. At least two drafts of the issue development papers are planned, in addition to the final set of papers that incorporates comments from peer review.

a. Concepts of the Lower Limit to Measurement [ STAT ( Chuck)]

Summarizes the results of a literature review on detection and quantitation. Includes a history of the MDL in EPA's water program, data censoring, and how different interest groups see the issues. [ We will revise a review that was completed in 1998 to bring it up to date.]

b. Concepts in Relation to Office of Water Applications [ STAT]

Under section 304( h) of the Clean Water Act, EPA is required to promulgate measurement methods to support the development of permits under the National Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 4 Pollution Discharge Elimination System ( NPDES). Specific applications supporting this mission are listed below. While there are many similarities among applications with regard to use and interpretation of detection and quantitation estimates, differences among the applications also exist. For each application listed, methods for determining detection and quantitation estimates and their use will be evaluated based on a literature review and statistical theory.

i. Method Performance Verification at a Lab [ AMT]

Detection and quantitation estimates are used to evaluate the performance of individual labs in application of a particular method. This issue will be considered in regard to existing measurement methods and to measurement methods to be developed in the future.

ii. Method Development and Promulgation [ AMT]

Detection and quantitation estimates are often integral parts of measurement methods at the time they are published or promulgated. This application will be considered in light of the appropriate use and interpretation of detection and quantitation estimates in methods development.

iii. Effluent Guidelines Development [ STAT]

Detection and quantitation estimates are fundamental in various ways to the collection and analysis of data used in the development of technology based regulations for the treatment of wastewater.

iv. Water Quality Based Effluent Limits [ STAT]

Detection and quantitation estimates relate in various ways to the development of water quality based regulations for the discharge of wastewater.

v. Permit Compliance Monitoring [ STAT]

Evaluation will focus on the appropriate definition and use of detection and quantitation estimates in the monitoring of wastewater discharges for permit compliance.

vi. Non Regulatory Studies and Monitoring [ STAT]

Detection and quantitation estimates are integral to the design and implementation of non regulatory studies and monitoring of ambient water and wastewater discharges.

vii. Descriptive versus Prescriptive Uses of Lower Limits to Measurement [ STAT] Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 5 The procedures used to develop detection and quantitation estimates will be evaluated against the objectives of describing the expected capability of a new measurement method as used by any group of labs, as used by a highly proficient lab, or some other standard.

viii. Use of a pair of related detection and quantitation procedures in all Office of Water applications. [ STAT]

The evaluation will examine whether a single set of detection and quantitation procedures that are designed to work together may be adequate to meet the requirements of the different applications for detection and quantitation estimates listed above.

c. Criteria for the Selection and Appropriate Use of Statistical Models [ STAT]

Evaluate the extent to which models are useful in the analysis and interpretation of data that may be used in estimation of detection and quantification levels. Analysis will be based on a literature review, EPA's Episode 6000 data, and statistical theory. EPA's Episode 6000 data were collected for the purpose of evaluating the functional relationship between measurement variation and spike concentrations. These single lab generated data include measurement results over a wide range of concentrations from a variety of measurement techniques. Other data sets including interlab data used in the development of methods 1631 for mercury and 1638 for a number of metals by ICPMS may also be considered.

d. Methodology for Parameter Estimation [ STAT]

Evaluate statistical methodologies used for estimation of model parameters. Such methodologies may include maximum likelihood, least squares, Bayesian, iterative estimation, closed form estimation, and others. Precision and bias will be evaluation factors. Analysis will be based on a literature review, EPA's Episode 6000 data, simulations, and statistical theory.

e. Statistical Tolerance and Prediction [ STAT ( Henry)]

Evaluate the use of statistical tolerance and prediction in the development of detection/ quantitation procedures. Analysis will be based on a literature review and statistical theory.

f. Criteria for Design of Detection and Quantification Studies, Including Selection of Concentration Levels [ AMT/ STAT]

Selection of spiking levels and other related factors in the design of detection and quantitation studies will be considered. Analysis will be based on a literature review, EPA's Episode 6000 data, simulations, and statistical theory. Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 6 g. Sources of Variability [ STAT ( Henry)]

The estimation of various sources of variability and their impact will be considered for a number of sources. These sources include within and between lab variability, variability over time, and variability associated with calibration.

h. Incorporate Elements of Probability Design [ STAT ( Henry)]

Appropriate ways to integrate randomization into design of studies aimed at determining detection and quantitation levels will be considered. Analysis will be based on a literature review and statistical theory.

i. False Positives and False Negatives [ STAT]

Appropriate ways to deal with false positive and false negative measurements in the context of detection and quantitation. A false positive is a measurement result indicating the presence of a substance in a sample that does not contain the substance. A false negative is a measurement result indicating that a sample does not contain a substance that is in fact present in the sample. Analysis will be based on a literature review and statistical theory.

j. Measurement Quality over the Life of a Method [ AMT]

Measurement quality of an analytical method is expected to improve as experience in using the method accumulates. This phenomenon has been observed widely. EPA will discuss why this happens, present supporting data from EPA performance evaluation studies, and consider the implications for detection and quantitation.

k. Matrix effects [ AMT]

The sample matrix which is the collection of all substances in a sample, may have an effect on the ability of a measurement process to identify and quantify substances. Analysis of the influence of matrix effects on detection and quantitation will be based on measurement theory and experience.

l. Background Contamination [ AMT]

Background contamination of a sample is the addition of the substance of interest from extraneous sources in the lab or field. For example, methylene chloride is among the analytes of interest in the class of compounds known as volatile organics. It is also commonly used in laboratories as the solvent to extract organic compounds from environmental samples. As a result, it is not unusual for the residual methylene chloride vapors in the laboratory to increase the concentration of methylene chloride measured in a sample. Analytical methods for volatile organics include quality control samples such as field and laboratory blanks that can be used to identify when such contamination occurs. The evaluation of the effects of contamination on detection limit estimates will Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 7 considered on the basis of theoretical considerations, professional judgement and the results of the analysis of quality control samples.

m. Outliers [ STAT ( Henry)]

Outliers are measurement results generated by a different process than the one under study. Analysis will be based on a literature review and statistical theory.

n. Instrument Non Response [ STAT ( Henry)]

Instruments do not always produce a measurement result from an appropriately prepared sample. Sometimes this is due to uncontrollable instrument limitations, sometimes it is due to uncontrollable instrument settings ( thresholds) established by the manufacturer, and sometimes it is due to controllable thresholds. Analysis will be based on a literature review and statistical theory.

o. Accepting the Procedures of Consensus Organizations [ AMT]

Measurement methods, detection procedures, and quantitation procedures are all developed by voluntary consensus organizations. The National Technology Transfer and Advancement Act ( NTTAA) and OMB Circular A 119 require the Agency to accept consensus standards that meet the needs of the government for a particular application. Analysis will be based on legal requirements, regulation, and the needs of the Agency.

p. Completeness of Measurement Procedures with regard to Study Design and Implementation [ STAT]

Measurement procedures ( methods) may be more or less strictly designed. Variability in what is allowed in the procedures may add to variability in the measurement results. Analysis will be based on statistical theory.

q. Under what Conditions is a Measurement Method Described by a Limit Procedure [ STAT]

A detection or quantitation limit may be intended for one purpose but developed under somewhat different conditions. For example, it is difficult to develop detection and quantitation limits for routine measurement when the detection and quantitation limits must be established before routine measurement can begin. Analysis will be based on statistical theory.

r. National versus Local Standards for Measurement [ AMT]

EPA is writing national standards for detection/ quantitation estimates. However, local governments implementing EPA regulations may use standards that equal or are more stringent than the EPA standards. Proposed procedures for detection and quantitation Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 8 may impact the standards used by local governments. Analysis will be based on law, regulation, and experience.

s. Ability of Study Managers, Bench Chemists, and Study Statisticians to Do What Is Required by a Limit Procedure [ AMT]

Theoretically appealing procedures may not be practical to implement. Analysis will be based on experience.

t. Cost to Implement Limit Procedures [ AMT]

Technically possible and theoretically appealing procedures may be costly to implement. Analysis will be based on experience.

4. Criteria Development [ STAT]

Based on the evaluation of issues presented in Event 3, criteria for the selection of detection and quantitation methodology will be developed.

5. Evaluation of methods from Voluntary Consensus Standards Bodies ( VCSB)

Based on the criteria developed in Event 4, a number of VCSB procedures will be evaluated. Such standards will include those published by American Chemical Society ( ACS), American Society for Testing and Materials ( ASTM), International Standards Organization ( ISO), and the International Union of Pure and Applied Chemistry ( IUPAC). EPA plans to develop one draft of this evaluation in addition to the final documentation that takes into account comments received during peer review.

6. Reassessment of Existing Agency Procedures Based on the criteria developed in Event 4, the existing method detection limit ( MDL) and minimum level ( ML) procedures will be evaluated. EPA plans to develop one draft of this evaluation in addition to the final documentation that takes into account comments received during peer review.

7. Development of Alternative Procedures Modified MDL/ ML procedures or one or more alternate procedures will be developed and evaluated against the criteria developed in Event 4. Such alternatives may be modifications to existing procedures. EPA plans to develop at least two drafts of this evaluation in addition to the final documentation that takes into account comments received during peer review. Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 9 8. Evaluate Alternative Procedures Based on the criteria developed in Event 4, the alternative procedures developed in Event 7 will be evaluated. EPA plans to develop at least two drafts of this evaluation in addition to the final documentation that takes into account comments received during peer review.

9. Assemble Peer Review Package The peer review package will include documentation of EPA's issue development, criteria development, evaluation of procedures discussed above, operational definitions for any procedures to be proposed, and any supporting reports generated by EPA. EPA plans to put together the peer review package over a period of about two weeks.

10. External Peer Review and EPA Response [ SASB]

An external peer review will be conducted concerning the findings of this reassessment of existing procedures and assessment of alternatives. The charge to the external peer review panel will include the issues specified in the Settlement Agreement. The Petitioner and Intervenor will simultaneously review and comment on the peer review package.

11. Select Recommended Option The Core Workgroup will select a recommended option as part of the process of preparing materials for briefing management.

12. Write Federal Register Notice / Develop Record Write the Federal Register publication announcing the results of EPA's reassessment of existing procedures and assessment of alternatives. The announcement will include an opportunity for public comment and the comment period will be no less than 120 days. The legal record of this action is developed at the same time. A first draft of the publication will be produced concurrently with the end of peer review, multiple drafts are expected during the Agency Review process, and the final version will incorporate peer review comments.

13. Agency Review, Select Proposed Option, and Sign Off Brief the Agency Workgroup and multiple layers of EPA management to establish the Agency's proposed option.

14. OMB Review OMB has the option of taking ninety days to review any proposed regulation. Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 10 15. Administrator Signs Notice or Proposal EPA's Administrator reviews and signs the proposal. The notice or proposal is then forwarded to the Office of the Federal Register for publication.

16. Meet with Petitioners Under the Settlement Agreement, EPA is required to meet with petitioners once every six months in order to brief them on the progress of the reassessment/ assessment. A copy of this plan will be provided to the Petitioners on or before the meeting scheduled for December 2001.

Relationship of the Plan to the Settlement Agreement In this section, the pertinent portion of the settlement agreement is quoted and events in the plan addressing these issues are identified within brackets.

Pertinent Excerpt from the Settlement Agreement 6. Reassessment of Method Detection Limit and Minimum Level Procedures a. On or before February 28, 2003, EPA shall sign and forward to the Office of the Federal Register for prompt publication a notice inviting public comment on a reassessment of the existing Agency procedures for determination of sensitivity of analytic test methods for aqueous samples [ Events 11and 15], specifically, EPA procedures for determining the detection limits and levels of quantitation of contaminants in aqueous samples, including, at a minimum, the " Definition and Procedure for Determination of the Method Detection Limit" published at 40 C. F. R. Part 136, Appendix B, as well as the " minimum level" procedures, which is described in section 17.8 of Method 1631B [ Event 6]. The notice shall invite comment on EPA's evaluation of one or more alternative procedures for determining and describing test sensitivity [ Events 7 and 11]. The notice also may propose modifications to the existing procedures [ Events 7 and 11]. The notice shall invite public comment for a period of no less than one hundred twenty ( 120) days [ Event 11].

b. Prior to publishing the notice inviting public comment on EPA procedures for determining test sensitivity, EPA shall submit its reassessment of existing procedures ( including any proposed modifications thereof) and its evaluation of alternatives for peer review by experts in the field of analytical chemistry and the statistical aspects of analytical data interpretation [ Event 10]. In its charge to the peer review panel, EPA shall request that the peer review consider: criteria for selection and appropriate use of statistical models [ Event 3. c.]; methodology for parameter estimation [ Event 3. d.]; statistical tolerance and prediction [ Event 3. e.]; criteria for design of detection and quantification studies, including selection of concentration levels (" spiking levels") [ Event 3. f.]; interlaboratory variability [ Event 3. g.]; and incorporation of elements of probability design [ Event 3. h.]. EPA ( or its authorized representative) shall conduct the Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 11 peer review in accordance with EPA's current peer review policies in the January 1998 Science Policy Council Handbook ( EPA 100 B 98 00), including any subsequentlydeveloped EPA peer review documents that may revise or amend that Handbook [ Event 10].

[ c. Note  there is no clause " 6. c" in the settlement agreement]

d. During the peer review period, EPA shall also provide an opportunity for concurrent review and comment by the Petitioners and Intervenor [ Event 10].

e. In the development of the reassessment/ assessment of alternatives, EPA shall provide the Petitioners and Intervenor with a periodic opportunity to meet ( i. e., every six ( 6) months) on the Agency's progress. EPA shall prepare and present the Petitioners and Intervenor with the Agency's " plan" for conducting the reassessment/ assessment of alternatives on or before the second such periodic meeting [ Event 16]. Where appropriate, EPA shall provide the Petitioners and Intervenor with copies of relevant documents in advance of such meetings.

f. On or before September 30, 2004, EPA shall sign and forward to the Office of the Federal Register for prompt publication a notice taking final action on the notice described in subparagraph 6. a. Coincident with publication of the notice of final action, EPA shall provide Petitioners and Intervenor an opportunity to meet to discuss the implications of the final notice and/ or the need for any subsequent EPA action in light of the final notice [ The current plan does not include events occurring after signature on the notice or proposal]. Plan for Detection and Quantitation, Draft Version 03 ( December 4, 2001) Page 12


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

Chemical: Chlorpyrifos-methyl

PC Code: 059102

              DP Barcode: 370120

DATE: November 23, 2009

MEMORANDUM

SUBJECT:  Registration Review – Problem Formulation for
Chlorpyrifos-methyl

FROM:		Donna Judkins, Biologist

				Mark Corbin, Senior Environmental Scientist

THROUGH: 	Dana Spatz, Branch Chief

				Environmental Risk Branch 3

		            Environmental Fate and Effects Division

		            Office of Pesticide Programs

TO:				Veronique LaCapra, Chemical Review Manager

				Reregistration Branch 2

				Pesticide Re-Evaluation Division

				Office of Pesticide Programs

Attached is the preliminary problem formulation, a part of the
registration review, for the insecticide Chlorpyrifos-methyl.

REGISTRATION REVIEW

PROBLEM FORMULATION FOR:

CHLORPYRIFOS-METHYL

Chlorpyrifos-methyl (CAS 5598-13-0)

PREPARED BY:

Donna Judkins, Ph.D., Biologist

Mark Corbin, Senior Environmental Scientist

APPROVED BY:

Dana Spatz, Branch Chief

Environmental Risk Branch 3

Environmental Fate and Effects Division

Office of Pesticide Programs

STRESSOR SOURCE AND DISTRIBUTION

Chlorpyrifos-methyl is an insecticide used to target and kill a variety
of insects including beetles, weevils, moths, and grain borers.
Chlorpyrifos-methyl has two current registrations (EPA Reg # 264-992 and
62719-42) for treatment of grains in storage bins and warehouses.
Chlorpyrifos- methyl is applied indoors with one application per year by
sprayer or automatic sprayer at a rate of 0.0253 lbs ai/1,000 square
feet.   Based on the most recent usage data provided by BEAD
chlorpyrifos-methyl has been applied predominantly on stored grains with
approximately 110,000 lbs applied annually.

Table 1. Chemical Registration Data Summary

Common name		Chlorpyrifos-methyl

Chemical name	Chlorpyrifos-methyl [C7H7Cl3NO3PS]

CAS number	5598-13-0

Pesticide type	Insecticide

PC Code	059120

EPA Registration Numbers	264-992 (Bayer Crop Science STORCIDE II (21.6%
active)) & 62719-42 (Dow AgroSciences Reldan* F Insecticidal Chemical
(97% active))

INTEGRATION OF AVAILABLE INFORMATION

The documents available in the Office of Pesticide Programs Regulatory
Docket and which serve as the basis for this problem formulation include
the following:

1980 Ecological Risk Assessment

December 2000 Tolerance Reassessment

October 2000 Pesticide Fact Sheet

December 2007 Product Cancellation Order

ECOLOGICAL EFFECTS

No ecotoxicological data have been required by EPA in past assessments
of chlorpyrifos-methyl since all uses were indoor.  However, according
to product labels, all end-use products are toxic to extremely toxic to
fish, birds and other wildlife; therefore, it is not allowed to be used
on or near water or on seed to be fed to birds or wildlife.  Data from
earlier risk assessments indicate that chlorpyrifos-methyl is
practically nontoxic to moderately toxic to avian wildlife based on
dosing studies (LD50, 100->2000 mg/Kg); practically nontoxic to slightly
toxic to avian wildlife based on dietary studies (LC50, 1835->5000
mg/L); moderately toxic to very highly toxic to fish based on acute data
(LC50, 0.014-4.58 mg/L); and slightly toxic to very highly toxic to
aquatic invertebrates based on acute tests (LC50, 0.00017-45.8 mg/L);
and very highly toxic to honeybees based on acute studies (LD50,
0.088-0.383 µg/bee).

EXPOSURE CHARACTERISTICS

No acceptable environmental fate data have been submitted to EPA for
chlorpyrifos-methyl.  The environmental fate and metabolism of
chlorpyrifos-methyl are expected to be similar to the environmental fate
and metabolism for chlorpyrifos.  Previously, data summaries were
prepared by EFED that present overviews of the environmental fate as
captured in open literature.  These data suggest that
chlorpyrifos-methyl is relatively non-persistent under biotic (aerobic
soil metabolism and field dissipation studies) and abiotic conditions
(hydrolysis) based on both laboratory and field data with half lives
generally less than 30 days.  An exception to this is that hydrolysis
half lives are longer (i.e., up to 76 days) at colder temperatures
(i.e., 15 degrees Celsius) and is more stable under acidic conditions.
Finally, chlorpyrifos-methyl is relatively immobile with Koc’s between
3,000 and 4,500.

Chlorpyrifos-methyl does not appear in any of the surface or groundwater
monitoring data sets reviewed, however, this could be due to the fact
that most monitoring programs are not analyzing for it.

Table 2.  Physical and Chemical Properties of Chlorpyrifos-methyl

Empirical formula	C7H7Cl3NO3PS

Molecular mass (g/mol)	322.6

Vapor pressure	4.22 x 10-5 mm Hg at 25 oC

Solubility in water 	4 mg/L

Kow 	4.3

pKa	NA

Hydrolysis half-life	3 days to 76 days

ANALYSIS PLAN

Chlorpyrifos-methyl is used as an indoor treatment for small grains in
storage bins and warehouses.  The product is applied by manual and
automatic sprayer in self-contained units applied in discrete locations
with a spatial extent limited to building size areas with negligible
potential for offsite transport.  The application method does not allow
for drift to terrestrial areas or to water bodies.  The units are not
intended for moist areas and do not contain amounts of active ingredient
sufficient for runoff to be a concern.  Direct or indirect exposure to
humans or ecological receptors is not expected.  If used as directed on
the product label, then the likelihood of exposure to non-target
wildlife is minimal. Therefore, ecological exposure and effects are not
expected from this use.  In addition, the use pattern is unlikely to
result in exposure in aquatic resources or groundwater and thus drinking
water is unlikely to be impacted by this use.

According to 40 CFR Part 158, avian oral toxicity, freshwater fish acute
toxicity and freshwater invertebrate acute toxicity data are
conditionally required for the indoor use pattern, depending on whether
or not there is a potential for environmental exposure.  Since the use
of the currently registered products containing chlorpyrifos-methyl is
not expected to result in environmental exposure, no additional
ecological effects data are required.

The Agency anticipates that no quantitative ecological risk assessment
or drinking water assessment will be needed. Because these uses are
indoors, it is unlikely that listed species will be impacted and thus a
quantitative endangered species assessment will not be conducted.

 PAGE

 PAGE   5

OFFICE OF

       PESTICIDES PROGRAMS


[Federal Register: February 2, 2009 (Volume 74, Number 20)]
[Notices]
[Page 5891-5892]
[DOCID:fr02fe09-105]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petition for Exemption From the Vehicle Theft Prevention
Standard; Mitsubishi Motors

AGENCY: National Highway Traffic Safety Administration (NHTSA)
Department of Transportation (DOT).

ACTION: Grant of petition for exemption.

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

SUMMARY: This document grants in full the Mitsubishi Motors R&D of
America (Mitsubishi) petition for exemption of the Mitsubishi Outlander
vehicle line in accordance with 49 CFR part 543, Exemption from the
Theft Prevention Standard. This petition is granted because the agency
has determined that the antitheft device to be placed on the line as
standard equipment is likely to be as effective in reducing and
deterring motor vehicle theft as compliance with the parts-marking
requirements of the Theft Prevention Standard (49 CFR part 541).
Mitsubishi requested confidential treatment for some of the information
and attachments it submitted in support of its petition. The agency
will address Mitsubishi's request for confidential treatment by
separate letter.

DATES: The exemption granted by this notice is effective beginning with
the 2011 model year.

FOR FURTHER INFORMATION CONTACT: Ms. Carlita Ballard, Office of
International Policy, Fuel Economy and Consumer Programs, NHTSA, 1200
New Jersey Avenue, SE., Washington, DC 20590. Ms. Ballard's phone
number is<PHONE_NUMBER>. Her fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a petition dated September 26, 2008,
Mitsubishi requested exemption from the parts-marking requirements of
the Theft Prevention Standard (49 CFR Part 541) for the Mitsubishi
Outlander vehicle line beginning with MY 2011. The petition requested
an exemption from parts-marking pursuant to 49 CFR part 543, Exemption
from Vehicle Theft Prevention Standard, based on the installation of an
antitheft device as standard equipment for the entire vehicle line.
    Under Sec.  543.5(a), a manufacturer may petition NHTSA to grant an
exemption for one vehicle line per model year. In its petition,
Mitsubishi provided a detailed description and diagram of the identity,
design, and location of the components of the antitheft device for the
Outlander vehicle line. Mitsubishi will install a passive, transponder-
based, electronic engine immobilizer device as standard equipment on
its Outlander vehicle line beginning with MY 2011. Features of the
antitheft device will include an electronic key, electronic control
unit (ECU), and a passive immobilizer. Mitsubishi will also incorporate
an alarm system as standard equipment on all trimline vehicles.
Mitsubishi's submission is considered a complete petition as required
by 49 CFR 543.7, in that it meets the general requirements contained in
543.5 and the specific content requirements of 543.6.
    Mitsubishi further explained that entry models for the Outlander
vehicle line will be equipped with an immobilizer that functions via a
Wireless Control Module (WCM). Mitsubishi stated that this is a keyless
entry system in which the transponder is located in a traditional key
that must be inserted into the key cylinder in order to activate the
ignition. All other models of the Outlander vehicle line are equipped
with an immobilizer that functions via a Keyless Operation System
(KOS), which utilizes a keyless system that allows the driver to push a
knob in the steering lock unit to activate the ignition (instead of
using a traditional key in the key cylinder) as long as the transponder
is located in close proximity to the driver inside the vehicle.
Mitsubishi stated that the construction and performance of the
immobilizer will be the same in all models whether the vehicle has a
WCM or KOS entry system. Mitsubishi further stated that the only
difference between the two keyless entry systems is the ``key'' and the
method used to transmit the information from the key to the
immobilizer.
    Specifically, once the ignition switch is turned to the ``on''
position, the transceiver module reads the specific ignition key code
for the vehicle and transmits an encrypted message containing the key
code to the electronic control unit (ECU). The immobilizer receives the
key code signal transmitted from either type of key (WCM or KOS) and
verifies that the key code signal is correct. The immobilizer then
sends a separate encrypted start-code signal to the engine ECU to allow
the driver to start the vehicle. The power train only will function if
the key code matches the unique identification key code previously
programmed into the ECU. If the codes do not match, the power train
engine and fuel system will be disabled.
    In addressing the specific content requirements of 543.6,
Mitsubishi provided information on the reliability and durability of
its proposed device. To ensure reliability and durability of the
device, Mitsubishi conducted tests

based on its own specified standards. Mitsubishi provided a detailed
list of the tests conducted and believes that the device is reliable
and durable since the device complied with its specific requirements
for each test. Mitsubishi additionally stated that its immobilizer
system is further enhanced by several factors making it very difficult
to defeat. Specifically, Mitsubishi stated that communication between
the transponder and the ECU are encrypted and have trillions of
different possible key codes that make successful key code duplication
virtually impossible. Mitsubishi also stated that its immobilizer
system and the ECU share security data during vehicle assembly that
make them a matched set. These matched modules will not function if
taken out and reinstalled separately on other vehicles. Mitsubishi also
stated that it is impossible to mechanically override the system and
start the vehicle because the vehicle will not be able to start without
the transmission of the specific code to the electronic control module.
Lastly, Mitsubishi stated that the antitheft device is extremely
reliable and durable because there are no moving parts, nor does the
key require a separate battery.
    Mitsubishi informed the agency that the Outlander vehicle line was
first equipped with the proposed device beginning with it's MY 2007
vehicles. Additionally, Mitsubishi informed the agency that its Eclipse
vehicle line has been equipped with the device beginning with it's MY
2000 vehicles. Mitsubishi stated that the theft rate for the MY 2000
Eclipse decreased by almost 42% when compared with that of it's MY 1999
Mitsubishi Eclipse (unequipped with an immobilizer device). Mitsubishi
also revealed that the Galant and Endeavor vehicle lines have been
equipped with a similar type of immobilizer device since January and
April 2004 respectively. The Mitsubishi Galant and Endeavor vehicle
lines were both granted parts-marking exemptions by the agency and the
average theft rates using 3 MY's data is 4.4173 and 2.9564
respectively. Therefore, Mitsubishi has concluded that the antitheft
device proposed for its vehicle line is no less effective than those
devices in the lines for which NHTSA has already granted full exemption
from the parts-marking requirements.
    Based on the evidence submitted by Mitsubishi, the agency believes
that the antitheft device for the Outlander vehicle line is likely to
be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of the Theft Prevention
Standard.
    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.7(b), the agency grants
a petition for an exemption from the parts-marking requirements of part
541 either in whole or in part, if it determines that, based upon
substantial evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of part 541. The agency
finds that Mitsubishi has provided adequate reasons for its belief that
the antitheft device will reduce and deter theft. This conclusion is
based on the information Mitsubishi provided about its device.
    The agency concludes that the device will provide the five types of
Performance listed in Sec.  543.6(a)(3): promoting activation; attract
attention to the efforts of an unauthorized person to enter or move a
vehicle by means other than a key; preventing defeat or circumvention
of the device by unauthorized persons; preventing operation of the
vehicle by unauthorized entrants; and ensuring the reliability and
durability of the device.
    For the foregoing reasons, the agency hereby grants in full
Mitsubishi's petition for exemption for the Outlander vehicle line from
the parts-marking requirements of 49 CFR part 541. The agency notes
that 49 CFR part 541, Appendix A-1, identifies those lines that are
exempted from the Theft Prevention Standard for a given model year. 49
CFR part 543.7(f) contains publication requirements incident to the
disposition of all part 543 petitions. Advanced listing, including the
release of future product nameplates, the beginning model year for
which the petition is granted and a general description of the
antitheft device is necessary in order to notify law enforcement
agencies of new vehicle lines exempted from the parts-marking
requirements of the Theft Prevention Standard.
    If Mitsubishi decides not to use the exemption for this line, it
must formally notify the agency, and, thereafter, the line must be
fully marked as required by 49 CFR parts 541.5 and 541.6 (marking of
major component parts and replacement parts).
    NHTSA notes that if Mitsubishi wishes in the future to modify the
device on which this exemption is based, the company may have to submit
a petition to modify the exemption. Part 543.7(d) states that a Part
543 exemption applies only to vehicles that belong to a line exempted
under this part and equipped with the antitheft device on which the
line's exemption is based. Further, Sec.  543.9(c)(2) provides for the
submission of petitions ``to modify an exemption to permit the use of
an antitheft device similar to but differing from the one specified in
that exemption.''
    The agency wishes to minimize the administrative burden that part
543.9(c)(2) could place on exempted vehicle manufacturers and itself.
The agency did not intend part 543 to require the submission of a
modification petition for every change to the components or design of
an antitheft device. The significance of many such changes could be de
minimis. Therefore, NHTSA suggests that if the manufacturer
contemplates making any changes the effects of which might be
characterized as de minimis, it should consult the agency before
preparing and submitting a petition to modify.

    Authority: 49 U.S.C. 33106; delegation of authority at 49 CFR
1.50.

    Issued on: January 27, 2009.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
 [FR Doc. E9-2108 Filed 1-30-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 86, Number 197 (Friday, October 15, 2021)]
[Notices]
[Pages 57418-57419]
[FR Doc No: 2021-22497]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-69-000]

Indeck Niles, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Indeck Niles, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 28, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access

who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: October 8, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-22497 Filed 10-14-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 141 (Wednesday, July 22, 2020)]
[Notices]
[Pages 44294-44295]
[FR Doc No: 2020-15865]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4428-011]

Walden Hydro, LLC; Notice of Application Accepted for Filing and
Soliciting Motions To Intervene and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 4428-011.
    c. Date filed: May 29, 2020.
    d. Applicant: Walden Hydro, LLC.
    e. Name of Project: Walden Hydroelectric Project.
    f. Location: On the Wallkill River, in the Village of Walden,
Orange County, New York. The project does not occupy any federal land.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)--825(r).
    h. Applicant Contact: Ms. Elise Anderson, Senior Environmental
Permitting Specialist, Walden Hydro, LLC, Enel Green Power North
America, Inc., 100 Brickstone Square, Suite 300, Andover, MA 01810;
Phone at<PHONE_NUMBER> or email at<EMAIL_ADDRESS>    i. FERC Contact: Samantha Pollak at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests: September
14, 2020.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted but is not ready for
environmental analysis at this time.
    l. The Walden Project consists of the following existing
facilities: (1) A 417-foot-long, V-shaped concrete dam topped with 2-
foot-high flashboards; (2) an impoundment with a surface area of 69
acres at the normal pool elevation of 321.3 feet National Geodetic
Vertical Datum of 1929 (NGVD29); (3) an intake structure consisting of
a 252-foot-long, 56-foot-wide, 18-foot-deep canal forebay; (4) four 40-
foot-long steel penstocks; (5) a 60-foot-long, 45-foot-wide, 29-foot-
high powerhouse containing three horizontal double-runner Francis
turbine units with ratings of 980 kilowatts (kW), 630 kW, and 500 kW,
respectively for a total rated capacity of 2,110 kW; (6) a 30-foot-
long, 37-foot-wide tailrace; (7) a 230-foot-long bypassed reach
consisting primarily of bedrock; (8) a transmission line; (9) a
substation with a single-phase 12.5-kilovolt transformer; and (10)
appurtenant facilities.
    The project operates in a run-of-river mode with a minimum flow of
31 cubic feet per second. The project has an average annual generation
of 3,333 megawatt-hours between 2012 and 2019.
    m. The Commission provides all interested persons with an
opportunity to view and/or print the EA via the internet through the
Commission's Home Page (http://www.ferc.gov) using the eLibrary link.
Enter the docket number, excluding the last three digits in the docket
number field, to access the document. At this time, the Commission has
suspended access to the Commission's Public Reference Room, due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19), issued by the President on March 13,
2020. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY,
(202) 502-8659.
    You may also register online at https://ferconline.ferc.gov/eSubscription.aspx to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests filed, but
only those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any protests
or motions to intervene must be received

on or before the specified deadline date for the particular
application.
    All filings must (1) bear in all capital letters the title PROTEST
or MOTION TO INTERVENE; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. Agencies may obtain
copies of the application directly from the applicant. A copy of any
protest or motion to intervene must be served upon each representative
of the applicant specified in the particular application.
    o. Procedural Schedule: The application will be processed according
to the following schedule. Revisions to the schedule will be made as
appropriate.
    Issue Scoping Document 1 for comments: November 2020.
    Request Additional Information (if necessary): January 2021.
    Issue Scoping Document 2 (if necessary): February 2021.
    Issue Notice of Ready for Environmental Analysis: February 2021.
    Commission issues EA: September 2021.
    Comments on EA: October 2021.

    Dated: July 16, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-15865 Filed 7-21-20; 8:45 am]
BILLING CODE 6717-01-P


An innovative approach to hazard communication training

Michelle Dean, Environmental Inspector

George Goodale, Administrative Officer

Gailla Rogers, EQWIP Administrator

Public Works Department

City of Kansas City, Missouri

Field employees from the Street and Traffic Division of the Kansas City,
Missouri, Public Works Department, have implemented a computerized
training program designed to enhance employee understanding of the
federal Hazard Communication ("HazCom") Standard. The HazCom Standard is
described in Title 29 of the Code of Federal Regulations, Part
1910.1200. The computer program, developed by the employees, is designed
to replace classroom training and to allow individuals to learn at their
own pace. Public Works Director, George E. Wolf, Jr., P.E.,
congratulated the team for "...developing and completing an innovative
project to help train employees on hazardous materials."

The HazCom Standard, commonly referred to as the "Employee
Right-To-Know" Law, requires that both employers and employees be aware
of the potential hazards of the chemicals in the workplace in order to
avoid injury and property damage. The Standard requires that employers
develop and implement a HazCom Program that establishes procedures for
the protection of employees from the hazards associated with chemical
containing products, to include the inventory of products containing
hazardous chemicals (hazard evaluation), collection of Material Safety
Data Sheets (MSDSs) for chemicals being used, labeling of containers,
and employee training.

The employee team is one of seventeen active in the Public Works
Department's Employee Quality Work Improvement Process, referred to as
"EQWIP." In place for the past ten years, EQWIP gets employees directly
involved in improving their work processes. Employees are trained in
successful team building and the nine-step EQWIP problem-solving process
called "SOLVE"-Solvable Problems, Observable Causes, Logical Solutions,
Validation by Management, and Empirical Results. EQWIP teams come up
with a process improvement statement, solution implementation plan,
management presentation, and evaluate their results. EQWIP
Administrator, Gailla Rogers, stated, "This has been a wonderful EQWIP
project with wonderful results that will be very beneficial to the field
employees."

Work on the project began in June 1998 when the team reviewed the
division's written HazCom Program and then surveyed coworkers on their
knowledge of the Standard and preferences on training format. The survey
received a 41 percent response rate and revealed that much needed to be
done with regards to rolling out HazCom education within the division.
Additionally, the survey revealed that employees were receptive to
computer-based interactive training.

In March 1999, the team presented its findings to management and
approval was given to design and implement a CD-ROM-based interactive
training program for employees of the Street and Traffic Division. The
team selected the firm of Management Strategies Group, Inc. (MSG) based
in Blue Springs, Missouri, to assist in the design and provide technical
support for development. MSG contracts with the City to provide a broad
range of environmental and safety training to City employees. By August
2000, the team had completed research on Material Safety Data Sheets
(MSDS) and development of training curricula on 46 chemicals in use
within the division. Information from each MSDS was then summarized into
a standard format and included test questions designed to educate
employees about the essentials and test their knowledge of hazardous
chemicals in the workplace. In October 2000, the team executed a
contract with MSG to produce the training CD-ROM, which was delivered in
August 2001 at a production cost of nine thousand dollars. The training
CD-ROM is programmed with Macromedia Authorware. When the CD-ROM needs
to be revised, such as adding or deleting chemical summaries, the
Division intends to contract with MSG at a nominal cost.

After receiving the finished CD-ROM, Jere Meredith, P.E., Manager of the
Street and Traffic Division, stated: "I have reviewed it and find it to
be very good. By the way, I made a 100 percent on the test. I am
especially impressed by the use of a number of employees' voices and the
on-site photos. This CD will be a tremendous asset in our training
program. Thanks for your efforts." The Division's 280 employees maintain
and clean streets and perform traffic control operations and engineering
services. The Division has five work locations: City Hall, District One,
District Two, District Three, and Traffic Operations.

Early in the project, the team decided that the HazCom training program
should not only be effective in training employees on hazard
communication issues and on hazardous materials used by the Street and
Traffic Division, but it should also be efficient by replacing classroom
training to minimize training costs, minimize supervisor training time,
automate training record-keeping, maximize employee learning
opportunities, and be simple and inexpensive to update as needed.
Typically, classroom training, whether off-site or on-site, would
interrupt work crew production for a day and require hiring of an
outside contractor to conduct the training. However, with CD-ROM
interactive training now in place, employees can train individually at
their own pace.

The CD-ROM is organized into five sections. Section One, Hazard
Communication Standard, introduces students to the HazCom Standard and
discusses labeling and the National Fire Protection Association (NFPA)
diamond placard. Section Two, The Steps To Compliance, introduces the
student to the six major steps to an effective HazCom program. Section
Three, Understanding the MSDS, discusses the elements of an MSDS and the
essential information they contain. Section Four, Summary Test, tests
student proficiency on the material presented in Sections 1, 2 and 3.
Section Five, Street and Traffic Division Chemicals, contains MSDS
information on 46 chemicals used by the Street and Traffic Division. The
chemicals are grouped into ten Chemical Categories:

1. Automotive and Lubricants: CAT Diesel Engine Oil 15W-40; Four Seasons
Permanent Antifreeze; Power Lube (aerosol); Schaeffer #238 Moly Supreme
#2; Superclean Windshield Washer Fluid

2. Fuels: Conoco No. 2 Diesel Fuel; Conoco Unleaded Gasoline; Ferrellgas
Propane; Premium Butane Fuel (2.1 fl oz.); Ultrasorb

3. Janitorial: Boraxo Special Heavy Duty Powdered Hand Soap; Castile No.
15 Hand Soap; Cello Mop'N Strip Floor Finish Liquifier; Champion
Disinfectant Spray; Champion Stainless Steel Cleaner; GoJo Natural
Orange Smooth Hand Cleaner; KC Bowl Cleaner; KC Sanitary Porcelain
Cleaner; Novel Wash Clear/Sudsy/Lemon Ammonia; Sodium Hypochlorite 5.25%
Regular/Fresh Scent/Lemon (Always Save Best Choice Liquid Bleach); Zep
Big Orange

4. Office: EP-E cartridge black (for printer); Savin 9027/9027DL/
9035/9035DL Toner (for photocopier); T-Q23 Toner (for facsimile)

5. Pavement Markings: (17A) Marking Paint-All Colors; 3M "Stamark"
Contact Cement E-44T; Hotline Traffic Paint (Acrylic Waterborne) White
TM-2174

6. Sign Fabrication: 3M Scotchlite Process Color 708 Green; Dirasol 914
"Part B" Sensitizer; Dirasol 914 Phthalate Free "Part A" Emulsion;
Dowanol(r) DPM Glycol Ether

7. Snow Removal: Liquidow(r) 30-42% Calcium Chloride Solution; Silica
Dioxide, Quartz (Sand); Sodium Chloride (Rock Salt)

8. Street Maintenance: Coal Tar Emulsion; Crackfiller (Rubberized); Hot
Mix Asphalt; Poly Perm Patch; Portland Cement; Pothole Mix, Cold Mix
Asphalt

9. Traffic Signals: All Weather Quickset Clear Cement; PS 2000 Gray
Traffic Loop Sealant; Scotch Brand 1607 Heavy Duty Contact Cleaner

10. Welding: Acetylene, Ethyne, Ethine; Fleetwood 37 Stick Electrode;
Oxygen (liquid and gas)

Each chemical's MSDS information is presented in six screens: (1)
manufacturer and address, MSDS date of publication, and emergency
contact number; (2) chemical appearance; (3) health hazard; (4)
emergency first aid; (5) special protection; and (6) fire and explosion
properties, reactivity, and spill and leak procedure. Students can elect
to progress through the screens in any sequence desired and can go
directly to the proficiency test offered for each Chemical Category.

Design of the CD-ROM is optimized for employees who want to know about
specific chemical hazards in the workplace and for new employees. It
features automatic record-keeping on student proficiency and allows the
results to be printed for placement into the employee's training file.
Color photographs of Street and Traffic Division facilities and
narrations provided by Public Works employees are included to enhance
the CD-ROM's appeal to students.

Orientation of the training software for Street and Traffic Division
employees occurred in November 2001. Each work location has the CD-ROM
and it is loaded onto supervisors' computers. Supervisors were the first
to receive the training so that they could then train their crews on
logging in and navigating through the training program. Students
generally spend an hour in front of the computer; however, the time
needed varies by student depending on their understanding of the course
material. Students have the option of reading the material themselves or
listening to the computer read to them. Results of the quizzes are
automatically scored, date-and-time stamped, and retained on the
computer. Supervisors print a record of the quiz, review the results and
determine if the student understands the course material presented, and
place the record in the training file for future reference.

New employees receive the training on their first day on the job and
others can take the training when they need a refresher, such as when
new chemicals are introduced into the workplace. The CD-ROM also reminds
employees to examine and follow the MSDS issued by the manufacturer when
using a chemical.

Deputy Director of Public Works, Larry Frevert, P.E., said that a
demonstration version of the training CD-ROM will soon be available and
can be downloaded from the Public Works Administrative Division website
at www.kcmo.org by governmental agencies that may be interested in
purchasing the full version from Kansas City, Missouri, Public Works.

To reach Michelle Dean, call<PHONE_NUMBER> or send e-mail to
<EMAIL_ADDRESS>to reach George Goodale, call<PHONE_NUMBER> or
send e-mail to<EMAIL_ADDRESS>to reach Gailla Rogers, call
(816) 513-2628 or send e-mail to<EMAIL_ADDRESS>


[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Page 78428]
[FR Doc No: 2014-30518]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2008-0719; FRL-9921-05-OW]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Effluent Guidelines and Standards for the Airport
Deicing Category

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Effluent Guidelines
and Standards for the Airport Deicing Category'' (EPA ICR No. 2326.02,
OMB Control No. 2040-0285) to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act
(44 U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public
comments on specific aspects of the proposed information collection as
described below. This is a proposed extension of the ICR, which is
currently approved through 03/31/2015. An Agency may not conduct or
sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before March 2, 2015.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2008-0719, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>(Identify Docket ID No. EPA-HQ-OW-2008-0719
in the subject line), or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Sarita Hoyt, State and Regional
Branch, Water Permits Division, OWM Mail Code: 4203M, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: This draft ICR calculates the burden and costs associated
with information collection and reporting activities required by EPA's
Effluent Limitations Guidelines and New Source Performance Standards
for the Airport Deicing Category (40 CFR part 449.10 and 449.20).
Respondents affected by this information collection request are covered
by either EPA's Multi-Sector General Permit (MSGP), an equivalent state
stormwater general permit, or an individual stormwater permit, and the
NPDES permitting authorities receive, process, and review permit
applications, and Notices of Intent (NOIs). Permitting authorities will
also process and review certifications of non-use of urea-based
deicers, and monitoring data as applicable.
    Form Numbers: None.
    Respondents/affected entities: The respondents affected by this
information collection request are commercial airports with at least
1,000 annual non-propeller aircraft departures.
    Respondent's obligation to respond: Mandatory (40 CFR part 449.10
and 449.20).
    Estimated number of respondents: 198 (total).
    Frequency of response: Annual.
    Total estimated burden: 198 hours (per year). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $6,534 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: The above estimates reflect what is currently
approved by OMB and they will be updated in the final ICR submission to
OMB. EPA expects that there will be little or no change in the burden.
The basis for these estimates is provided in the supporting statement.

    Dated: December 18, 2014.
Sheila E. Frace,
Acting Director, Office of Wastewater Management.
[FR Doc. 2014-30518 Filed 12-29-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 17, 2006 (Volume 71, Number 159)]
[Notices]
[Page 47496-47497]
[DOCID:fr17au06-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
To Intervene, Protests, and Comments

August 10, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12685-000.
    c. Date filed: June 13, 2006.
    d. Applicant: Don L. Hansen.
    e. Name of Project: Tapps Lake Dam Hydroelectric Project.
    f. Location: On the White River in Pierce County, Washington.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Don L. Hansen, 2517 NE. 1st Street,
Renton, Washington,<PHONE_NUMBER>, E-mail<EMAIL_ADDRESS>    i. FERC Contact: Patricia W. Gillis at<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would consist of
the following: (1) The existing 352-foot-long, 11-foot-high White River
Diversion Dam, (2) an existing impoundment having a surface area of
2,880 acres with a storage capacity of 67,000 acre-feet and normal
water surface elevation of 453 feet mean sea level, (3) two existing
intake structures, (4) an existing powerhouse containing four existing
generating units with an installed capacity of 70-megawatts, (5) an
existing 4,181-foot-long, 480 kilovolt transmission line; and (6)
appurtenant facilities. The proposed project would have an average
annual generation of 613.2 gigawatt-hours, which would be sold to a
local utility.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street, NE., Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>. This filing may
also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all

protests or other comments filed, but only those who file a motion to
intervene in accordance with the Commission's Rules may become a party
to the proceeding. Any comments, protests, or motions to intervene must
be received on or before the specified comment date for the particular
application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. Any of the above-named documents must be filed
by providing the original and the number of copies provided by the
Commission's regulations to: The Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    t. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives

Magalie R. Salas,
Secretary.
 [FR Doc. E6-13539 Filed 8-16-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Page 9716]
[FR Doc No: 2015-03642]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD15-4-000]

Technical Conference on Environmental Regulations and Electric
Reliability, Wholesale Electricity Markets, and Energy Infrastructure;
Supplemental Notice of Technical Conferences

    As announced in the Notice of Technical Conferences issued on
December 9, 2014 \1\ and the Supplemental Notice of Technical
Conferences issued on January 6, 2015,\2\ the Federal Energy Regulatory
Commission (Commission) staff will hold a Western Region \3\ technical
conference to discuss implications of compliance approaches to the
Clean Power Plan proposed rule, issued by the Environmental Protection
Agency (EPA) on June 2, 2014.\4\ The technical conference will focus on
issues related to electric reliability, wholesale electric markets and
operations, and energy infrastructure in the Western region. The
Commission will hold the Western Region technical conference on
February 25, 2015, from approximately 8:45 a.m. to 4:45 p.m. at the
Renaissance Denver Hotel, 3801 Quebec Street, Denver, CO 80207 (Phone:
(303) 399-7500). This conference is free of charge and open to the
public. Commission members may participate in the conference. The
agenda and list of speakers for the Western Region technical conference
is attached to this Supplemental Notice of Technical Conferences.
---------------------------------------------------------------------------

    \1\ Technical Conference on Environmental Regulations and
Electric Reliability, Wholesale Electricity Markets, and Energy
Infrastructure, Docket No. AD15-4-000, (Dec. 9, 2014) (Notice of
Technical Conferences), available at http://www.ferc.gov/CalendarFiles/20141209165657-AD15-4-000TC.pdf.
    \2\ Technical Conference on Environmental Regulations and
Electric Reliability, Wholesale Electricity Markets, and Energy
Infrastructure, Docket No. AD15-4-000, (Jan. 6, 2015) (Supplemental
Notice of Technical Conferences), available at http://www.ferc.gov/CalendarFiles/20150106170115-AD15-4-000TC1.pdf.
    \3\ For purposes of this conference, the Western Region includes
all the areas in the Western Interconnection, including the
California Independent System Operator (CAISO).
    \4\ Carbon Pollution Emission Guidelines for Existing Stationary
Sources: Electric Utility Generating Units, 79 FR 34,830 (2014)
(Proposed Rule), available at http://www.gpo.gov/fdsys/pkg/FR-2014-06-18/pdf/2014-13725.pdf.
---------------------------------------------------------------------------

    If you have not already done so, those who plan to attend the
technical conference are strongly encouraged to complete the
registration form located at: https://www.ferc.gov/whats-new/registration/02-25-15-form.asp. Those interested in attending the
Western region conference are encouraged to register by close of
business February 16, 2015.
    The Commission will post information on the technical conference on
the Calendar of Events on the Commission's Web site, http://www.ferc.gov, prior to the conference. The Western Region technical
conference will also be transcribed. Transcripts of the technical
conference will be available for a fee from Ace-Federal Reporters, Inc.
((202) 347-3700 or 1<PHONE_NUMBER>). There will also be a free
audiocast of the conference. The audiocast will allow persons to listen
to the Western region technical conference, but not participate. Anyone
with Internet access who desires to listen to the Western region
conference can do so by navigating to www.ferc.gov's Calendar of Events
and locating the Western region technical conference in the Calendar.
The Western region technical conference will contain a link to its
audiocast.\5\
---------------------------------------------------------------------------

    \5\ The audiocast will continue to be available on the Calendar
of Events on the Commission's Web site www.ferc.gov for three months
after the conference.
_____________________________________-

    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free 1 (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER>
with the required accommodations.
    For more information about the technical conferences, please
contact:

Logistical Information

    Sarah McKinley, Office of External Affairs, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426,
(202) 502-8368<EMAIL_ADDRESS>
Legal Information

    Alan Rukin, Federal Energy Regulatory Commission, 888 First Street
NE., Washington, DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>
Technical Information

    Matthew Jentgen, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
Technical Information

    Michael Gildea, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
    Dated: February 13, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-03642 Filed 2-23-15; 8:45 am]
BILLING CODE 6717-01-P


1 Summary of Summary of EPA Ethics Review EPA Ethics Review Wyld, P.; Watson, C.; Nimmo, W.; et al. ( 1992) A Safety and Tolerability Study of Aldicarb at Various Dose Levels in Healthy Male and Female Volunteers:

Lab Project No. 003237. Unpublished study prepared by Inveresk Clinical Research. 372 p.

( MRID 42373001) 2 Aldicarb Oral Study Aldicarb Oral Study

Conducted in 1992 at Inveresk Clinical Research

The first human toxicity study submitted to EPA since mid 1970s

Extensively supplemented with additional documentation of ethical conduct of the research 3 Aldicarb Aldicarb " Framework Framework"

1. Value  Not published or disseminated  Societal value not addressed in reports 2. Scientific Validity: Defer to others 3. Subject Selection  Adult volunteers from pool at laboratory  All females surgically sterile; 5 used twice  No evidence of use of vulnerable groups 4 Aldicarb Aldicarb " Framework Framework"

 2 4. Risk Benefit Ratio  Risks incompletely described to subjects  Societal or other benefits not addressed  Weighing of societal benefits against risks to subjects not addressed  Compensation of subjects not addressed 5 Aldicarb Aldicarb " Framework Framework"   3 5. Independent Ethics Review  Phases 1 and 2 ( males) and 3 ( females) conditionally approved by the Inveresk Independent Ethics Committee  Ethics committee charter provided  Committee members reported to be free from individual conflicts of interest  Organizational conflicts of interest not addressed  Directions of the committee  for expanded lay summary, a second review of the revised information, and modification of the standard letter to volunteers' physicians  were not carried out 6 Aldicarb Aldicarb " Framework Framework"

 4 6. Informed Consent  Consent was obtained from all subjects  Aldicarb was misleadingly characterized as a drug  Risks to subjects were incompletely described  Male subjects were not told doses to be administered 7 Aldicarb Aldicarb " Framework Framework"

 5 7. Respect for Subjects  Subjects' privacy was protected  Marginally protective stopping rule (> 70% RBC ChEI)

 Subjects free to withdraw 8 Aldicarb: Prevailing Standard Aldicarb: Prevailing Standard

Conducted in UK in 1992

Cites and asserts compliance with Declaration of Helsinki ( 1989)

Cites and asserts compliance with " principles of Good Clinical Practice" 9 Comparison to Comparison to DoH DoH

Basic Principle # 2: "[ The] experimental protocol . . . should be transmitted for consideration, comment and guidance to a specially appointed committee independent of the investigator and the sponsor. . . ."

EPA Comment: The independence of the reviewing ethics committee is called into question by the investigators' failure to respond to conditions the committee placed on their approvals of the research 10 Comparison to Comparison to DoH DoH

 2

Basic Principle # 4: " Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject."

EPA Comment: The protocol and study report are silent with respect to the nature and distribution of benefits of the research,

and incomplete in describing the risks to the subjects. 11 Comparison to Comparison to DoH DoH

 3

Basic Principle # 5: " Every . . . project . . . should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society."

EPA Comment: If a careful assessment of risks and benefits was conducted, it was not reported. The protocol rule permitting dosing to continue up to a level of 70% ChE inhibition, and the re use of five female subjects, suggest that the interests of the subjects may not always have prevailed. 12 Comparison to Comparison to DoH DoH

 4

Basic Principle # 9: ". . . each potential subject must be adequately informed of the aims, methods,

anticipated benefits and potential hazards of the study. . ."

EPA Comment: The adequacy of the lay summary and informed consent materials to support fully informed consent is questionable. 13 Comparison to Comparison to DoH DoH

 5

Basic Principle # 12: " The research protocol should always contain a statement of the ethical considerations involved . . . ."

EPA Comment: There is no such statement in the protocol 14 Aldicarb Summary Aldicarb Summary

Because of the supplemental submissions, more is known about this study than most.

Some gaps remain, but gaps are not " clear and convincing evidence".

There is no evidence that the research was fundamentally unethical.

Some deficiencies are apparent relative to the cited 1989 Declaration of Helsinki.

We welcome the Board's advice on the significance of those deficiencies. 15 Aldicarb Aldicarb Charge to the HSRB Charge to the HSRB Aldicarb is a N methyl carbamate ( NMC) pesticide whose primary toxic effect is neurotoxicity caused by the inhibition of the enzyme, acetylcholinesterase,

via carbamylation followed by rapid recovery.

Aldicarb can, at sufficiently high doses, lead to a variety of clinical signs. The Agency is conducting an acute, aggregate ( single chemical, multi route) risk assessment of aldicarb. In addition, aldicarb is a member of the N methyl carbamate common mechanism group and is thus included in the cumulative ( multi chemical, multi route) risk assessment for the NMCs. 16 Aldicarb Aldicarb Charge to the HSRB Charge to the HSRB 1. Scientific considerations:

The Agency's " Weight of the Evidence" ( WOE) document and Data Evaluation Records ( DERs) for aldicarb describe the study design and results of the aldicarb acute oral, human toxicity study. The WOE document also discusses the Agency's conclusions regarding the usefulness of the human study in the acute, aggregate, single chemical risk assessment and in the cumulative risk assessment for the NMCs. Regarding the aldicarb human study, the Agency has concluded that the study is sufficiently robust for reducing the inter species ( i. e., animal to human) uncertainty factor in the aggregate and the cumulative risk assessments. 17 Aldicarb Aldicarb Charge to the HSRB Charge to the HSRB 1. Scientific considerations, cont'd:

Please comment on the scientific evidence that supports whether the aldicarb human study is sufficiently robust for reducing the inter species ( i. e., animal to human)

uncertainty factor in:

a. single chemical, aggregate risk assessment and b. cumulative risk assessment. 18 Aldicarb Aldicarb Charge to the HSRB Charge to the HSRB 2. Ethical considerations:

a. The Agency requests that the Board provide comment on the following:

 In light of the ethics committee's instruction that the lay summary be " greatly expanded," and the fact that the materials used to obtain informed consent listed a limited range of symptoms of carbamate toxicity ( excluding some reported as adverse effects in the study), included multiple references to the test material as a drug, and failed to identify dose levels to be administered to male subjects, whether, the materials used to obtain informed consent should be considered significantly deficient relative to the ethical standards prevailing when the study was conducted 19 Aldicarb Aldicarb Charge to the HSRB Charge to the HSRB 2. Ethical considerations, cont'd:

a. cont'd. The Agency requests that the Board provide comment on the following:

 Whether the absence from the protocol of discussion of the potential risks to subjects or benefits to society of conducting the proposed research ( as required by the 1989 Declaration of Helsinki, Principle # 4, with which the research asserted compliance) should be considered significantly deficient relative to the ethical standards prevailing when the study was conducted; and 20 Aldicarb Aldicarb Charge to the HSRB Charge to the HSRB 2. Ethical considerations, cont'd:

b. The Agency asks that the Board provide comment on the following, taking into account all that is known about the ethical conduct of this study:

 OPP's conclusion that there is not clear and convincing evidence that the conduct of the research was fundamentally unethical.

 Whether there is clear and convincing evidence that the conduct of the study was significantly deficient relative to the ethical standards prevailing when the study was conducted