[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69470-69471]
[FR Doc No: 2014-27635]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0829; FRL-9919-22]

Pesticide Program Dialogue Committee; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Pursuant to the Federal Advisory Committee Act (FACA), EPA's
Office of Pesticide Programs (OPP) is announcing a public meeting of
the Pesticide Program Dialogue Committee (PPDC) on December 11-12,
2014. In addition, EPA is also announcing meetings on December 10,
2014, of the following PPDC workgroups: The Work Group on Integrated
Pest Management and the Work Group on Pollinator Protection. These
meetings provide advice and recommendations to the EPA Administrator on
issues associated with pesticide regulatory development and reform
initiatives, evolving public policy and program implementation issues,
and science issues associated with evaluating and reducing risks from
use of pesticides.

DATES: Meeting: The PPDC meeting will be held on Thursday, December 11,
2014, from 9 a.m. to 5 p.m., and Friday, December 12, 2014, from 9 a.m.
to noon.
    Work group meetings: On Wednesday, December 10, 2014, PPDC work
group meetings are scheduled as follows: The Work Group on Integrated
Pest Management, from 9 a.m. to 11:30 a.m., and the Work Group on
Pollinator Protection, from 1 p.m. to 4 p.m.

14P-0253
    Agenda: A draft agenda will be posted on or before December 2,
2014.
    Accommodations requests: To request accommodation of a disability,
please contact the person listed under FOR FURTHER INFORMATON CONTACT,
preferably at least 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

ADDRESSES: The PPDC meeting and both PPDC Work Group meetings will be
held at 1 Potomac Yard South, 2777 S. Crystal Dr., Arlington, VA, in
the lobby-level Conference Center.
    EPA's Potomac Yard South Bldg. is approximately 1 mile from the
Crystal City Metro Station.

FOR FURTHER INFORMATION CONTACT: Margie Fehrenbach, Office of Pesticide
Programs (7501P), Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you work in in
agricultural settings or if you are concerned about implementation of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the
Federal Food, Drug, and Cosmetic Act (FFDCA); and the amendments to
both of these major pesticide laws by the Food Quality Protection Act
(FQPA); the Pesticide Registration Improvement Act (PRIA); and the
Endangered Species Act (ESA). Potentially affected entities may
include, but are not limited to: Agricultural workers and farmers;
pesticide industry and trade associations; environmental, consumer, and
farm worker groups; pesticide users and growers; animal rights groups;
pest consultants; State, local, and tribal governments; academia;
public health organizations; and the public. If you have questions
regarding the applicability of this action to a particular entity,
contact the person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2014-0829, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal

holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. Background

    OPP is entrusted with responsibility to help ensure the safety of
the American food supply, the education and protection from
unreasonable risk of those who apply or are exposed to pesticides
occupationally or through use of products, and general protection of
the environment and special ecosystems from potential risks posed by
pesticides.
    The charter for EPA's PPDC was established under FACA, Public Law
92-463 (5 U.S.C. Appendix), in September 1995, and has been renewed
every 2 years since that time. PPDC's charter was renewed October 25,
2013, for another 2-year period. The purpose of PPDC is to provide
advice and recommendations to the EPA Administrator on issues
associated with pesticide regulatory development and reform
initiatives, evolving public policy and program implementation issues,
and science issues associated with evaluating and reducing risks from
use of pesticides. It is determined that PPDC is in the public interest
in connection with the performance of duties imposed on the Agency by
law. The following sectors are represented on the current PPDC:
Environmental/public interest and animal rights groups; farm worker
organizations; pesticide industry and trade associations; pesticide
user, grower, and commodity groups; Federal and State/local/tribal
governments; the general public; academia; and public health
organizations.
    Copies of the PPDC charter are filed with appropriate committees of
Congress and the Library of Congress and are available upon request.

III. How can I request to participate in this meeting?

    PPDC meetings are free, open to the public, and no advance
registration required. Public comments may be made during the public
comment session of each meeting or in writing to the person listed
under FOR FURTHER INFORMATION CONTACT.

    Authority: 7 U.S.C. 136 et seq.

    Dated: November 13, 2014.
Jack S. Housenger,
Director, Office of Pesticide Programs.
[FR Doc. 2014-27635 Filed 11-20-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 127 (Wednesday, July 7, 2021)]
[Notices]
[Pages 35790-35791]
[FR Doc No: 2021-14372]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: ER21-2246-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1894R10 Evergy Kansas
Central, Inc. NITSA NOA to be effective 9/1/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5116.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2247-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1897R11 Evergy Kansas
Central, Inc. NITSA NOA to be effective 9/1/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5122.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2248-000.
    Applicants: PacifiCorp.
    Description: Tariff Cancellation: Termination of UAMPS Const Agmt
for Heber 2nd POD to be effective 9/6/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5123.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2249-000.
    Applicants: Kentucky Utilities Company.
    Description: Sec.  205(d) Rate Filing: Revisions to Wholesale
Requirements Service Bardstown and Nicholasville to be effective 7/1/
2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5127.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2250-000.
    Applicants: Sayreville Power LP.
    Description: Sec.  205(d) Rate Filing: Notice of Succession and
Revisions to Tariffs (I) to be effective 5/18/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5128.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2251-000.
    Applicants: American Transmission Systems, Incorporated, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: ATSI submits Two ECSAs, SA
Nos. 5951 and 5952 to be effective 8/29/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5130.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2252-000.
    Applicants: Sayreville Power LP.
    Description: Sec.  205(d) Rate Filing: Notice of Succession and
Revisions to Tariffs (II) to be effective 5/18/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5129.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2253-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1892R10 Evergy Kansas
Central, Inc. NITSA NOA to be effective 9/1/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5136.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2254-000.
    Applicants: Assembly Solar I, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 6/30/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5150.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2255-000.
    Applicants: Dressor Plains Solar, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 6/30/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5144.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2256-000.
    Applicants: Iris Solar, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 6/30/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5145.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2257-000.
    Applicants: North Star Solar PV LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 6/30/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5146.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2258-000.
    Applicants: NRG Cottonwood Tenant LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 6/30/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5151.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2259-000.
    Applicants: Prairie State Solar, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 6/30/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5155.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2260-000.
    Applicants: St. James Solar, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 6/30/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5157.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2261-000.
    Applicants: Exelon Generation Company, LLC.
    Description: Sec.  205(d) Rate Filing: Reactive Service Rate
Schedule Filing for Deactivation of Units to be effective 9/14/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5158.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2262-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 2045R10 Evergy Kansas
Central, Inc. NITSA NOA to be effective 9/1/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5169.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2263-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1978R10 Evergy Kansas
Central, Inc. NITSA NOA to be effective 9/1/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5189.
    Comments Due: 5 p.m. ET 7/20/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings

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

    Dated: June 29, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-14372 Filed 7-6-21; 8:45 am]
BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I was able to stop smoking in just two days after a 22 year pack a day habit.  So I truly believe that electronic cigarettes saved my life.  I no longer have to worry about coughing, smelling bad, or things like getting cancer.  This has become a hobby for my husband and myself.  We enjoy going to the vapor bars on the weekends and trying free samples and socializing.  We get out of the house more now.  I don't have to hide it from my family members which reduces alot of stress in my life.  It's less expensive than smiling was and tastes better.  I enjoy all the flavors they come in.  Please don't make this so expensive that the small stores can't afford to stay open and I can't afford to purchase it.  It should be applauded instead of demonized for helping so many people to stop smoking.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register: June 25, 2008 (Volume 73, Number 123)]
[Notices]
[Page 36098]
[DOCID:fr25jn08-104]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1763-DR]

Iowa; Amendment No. 4 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Iowa (FEMA-1763-DR), dated May 27, 2008, and related
determinations.

EFFECTIVE DATE: June 15, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Iowa is hereby amended to include the following areas
among those areas determined to have been adversely affected by the
catastrophe declared a major disaster by the President in his
declaration of May 27, 2008.

    Cedar, Jones, Louisa, Muscatine, Polk, and Winneshiek Counties
for Individual Assistance.

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

R. David Paulison,
Administrator, Federal Emergency Management Agency.
 [FR Doc. E8-14323 Filed 6-24-08; 8:45 am]

BILLING CODE 9110-10-P


Page 1 of 19 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: March 21, 2006 SUBJECT: Human Studies Review Board: OPP's Approach for Incorporating Human Studies in Human Health Risk Assessment.

FROM: Ray Kent, Elissa Reaves, and Louis Scarano Health Effects Division ( 7509C)

THRU: Jack Housenger, Associate Director Health Effects Division ( 7509C)

TO: Tina Levine, Ph. D., Director Health Effects Division ( 7509C)

This background document is in support of the first public meeting of the Human Studies Review Board ( HSRB) scheduled for April 4 6, 2006. This document provides a general overview of the approaches used by EPA's Office of Pesticide Program when developing human health risk assessments and provides an overview of the ways in which human data may be used to support human health risk assessments for pesticide chemicals. A summary of the study design for the human studies being reviewed by the HSRB also is presented. Finally, this document provides the HSRB with a summary of the eleven intentional exposure human studies that will be the focus of this first meeting of the HSRB. Page 2 of 19 Purpose The first public meeting of EPA's new Human Studies Review Board ( HSRB or Board) is scheduled for April 4 6, 2006. The inaugural meeting will address scientific and ethical issues surrounding toxicity studies involving intentional exposure of human subjects to eight pesticide active ingredients: aldicarb, amitraz, azinphos methyl ( AZM), ethephon, dichlorvos ( DDVP), methomyl, oxamyl, and sodium cyanide. The Agency has provided the Board with a variety of materials which describe the ethical and scientific conduct of the studies. The Agency has also provided the Board with some background documents including some which describe EPA policies and/ or regulations. The purpose of this document is to provide a general overview of the approaches used by EPA's Office of Pesticide Program ( OPP) when developing human health risk assessments and to provide an overview of the ways in which human data may be used to support human health risk assessments for pesticide chemicals. A summary of the study design for the human studies being reviewed by the Board also is presented. The last section of this document provides a summary of the eleven intentional exposure human studies that will be the focus of the first HSRB meeting. In this document, they will be presented in the order they will be discussed at the meeting: Session 1   aldicarb, methomyl, and oxamyl ( the N methyl carbamates); Session 2   azinphosmethyl and DDVP, ( organophosphates); and Session 3   ethephon, amitraz, and hydrogen cyanide ( note: as a result of its use as a fumigant, sodium cyanide forms hydrogen cyanide; which will be the focus of this review).

Regulatory Background In the US, pesticide chemicals are registered for use by the Environmental Protection Agency ( EPA). EPA regulates the use of pesticides under the authority of two federal statues: the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and the Federal Food, Drug, and Cosmetic Act ( FFDCA). FIFRA, first passed in 1947, requires pesticide registration by EPA prior to the manufacture, transport, or sale in the US. FIFRA also provides the EPA with the authority to require data for the pesticide before registration. Under FFDCA, EPA establishes tolerances ( maximum allowable pesticide residue levels) for pesticide residues in foods and feeds. More recently the Food Quality Protection Act of 1996 ( FQPA) amended FIFRA and FFDCA, significantly changing the way EPA regulates pesticides. Some key changes by FQPA include the requirement to consider aggregate exposure, i. e., exposure to a single chemical by multiple pathways; cumulative assessment of multiple pesticides that share a common mechanism of toxicity; and the application of the FQPA 10X factor for the protection of infants and children. FQPA set a deadline of August 3, 2006 for EPA to reassess pesticide tolerances. EPA is currently in the final stages of completing its reassessment of more than nine thousand tolerances. Page 3 of 19 OPP's Approach to Human Health Risk Assessment Historically, EPA has focused on single pathways of exposure ( e. g., pesticide residues in food, water, or residential/ non occupational uses) for individual chemicals. The FQPA amendments to the FFDCA directed EPA OPP to consider " aggregate exposure" in single chemical assessments. " Aggregate risk" is defined by EPA OPP as the sum total of all exposure to pesticides through inhalation, dermal, oral, or optic contact ( USEPA, 2001a). Thus, aggregate risk is the risk to a single pesticide chemical from multiple routes and pathways of exposure ( e. g., food + water + residential). As part of single chemical risk assessments, EPA also assesses occupational risks resulting from a variety of work activities.

FQPA also required EPA OPP to consider " available evidence concerning the cumulative effects on infants and children of such residues and other substances that have a common mechanism of toxicity." Thus, cumulative risk is defined as the risk that may result from dietary, residential, or other non occupational exposure to multiple chemicals that have a common mechanism of toxicity. Cumulative risk assessments include multiple pathways and multiple chemicals. EPA OPP has developed a guidance document for developing cumulative risk assessments under FQPA ( USEPA, 2002). EPA is currently developing cumulative risk assessments for 4 groups of pesticides: organophosphates, N methyl carbamates, triazines, and chloroacetanilides.

Single chemical, aggregate assessments differ from cumulative risk assessments in scope and purpose. Regarding hazard assessment, single chemical assessments consider all potential toxicities; cumulative risk assessments focus on the common toxic effect for the common mechanism group. Specifically, single chemical risk assessments consider all possible toxicities and durations ( e. g., acute to chronic). Cumulative risk assessments focus on the common toxic effect and duration of exposure relevant to that common effect. As described below, there are a variety of ways in which human data can be incorporated into a single chemical hazard assessment. Some include use of human data as the point of departure for risk extrapolation ( i. e., NOAEL or benchmark dose) and to inform the interspecies extrapolation factor when animal data provide the point of departure and/ or the intraspecies extrapolation factor. An important step in cumulative hazard assessment is the determination of relative potency. Determinations of relative potency should be made, to the extent possible, using a uniform measure of toxicity with a single species, duration of exposure, and study design. To ensure that potency estimates are made with a single species, the Agency expects that relative potency estimates for cumulative risk assessments will most often be developed using laboratory animal data. Page 4 of 19 For those groups where no human data are available, the Agency will likely apply the default 10X factor for interspecies extrapolation1. Thus for cumulative risk assessments, human data, if available, may be used to inform the interspecies factor( s).

As part of the risk assessment process, EPA evaluates many toxicity studies. These studies are submitted to the Agency for a wide range of adverse effects and durations of exposure, from eye and skin irritation to cancer and developmental toxicity in laboratory animals. The studies also provide information regarding toxicity via different routes of exposure ( e. g., oral, dermal, and inhalation). EPA may also consult the public literature or other sources of supporting information on any aspect of the chemical. The majority of toxicity studies available to the Agency for developing hazard assessments are conducted on laboratory animals ( rat, mouse, rabbit, and dog). EPA occasionally receives human toxicity studies.

EPA's guidance documents for developing a reference dose ( RfD) and reference concentration ( RfC) and performing benchmark dose ( BMD) analysis ( USEPA 1994, 2000, 2002a) provide a comprehensive discussion of performing dose response analysis for risk assessment purposes. Briefly a point of departure ( PoD) is first selected to be protective of the critical effect for a particular pesticide. This approach is based, in part, on the assumption that if the critical toxic effect is prevented, then other toxicities may also be prevented. A PoD can be a benchmark dose estimate ( USEPA, 2000), no observed adverse effect level ( NOAEL), or a lowest observed adverse effectlevel ( LOAEL). Next, uncertainty and extrapolation factors are identified. Historically, EPA OPP has used a 10X factor for interspecies extrapolation ( i. e., extrapolation from animal to human, see footnote 2) and a 10X factor for intraspecies extrapolation to account for human variability. Where a NOAEL is not identified in the critical toxicity study, a LOAEL to NOAEL uncertainty factor may be applied. A database uncertainty factor may also be used when a key study ( e. g., developmental toxicity) is not available in the pesticide's toxicity database. Additionally, FQPA requires that EPA apply a 10X factor to account for added sensitivity of infants and children unless there is sufficient data to reduce this factor.

Types of Human Research in Pesticide Risk Assessment OPP utilizes a basic risk assessment model in assessing pesticide risks  estimating exposures associated with pesticide use, estimating delivered doses from information on exposure and chemical uptake, and comparing estimates of delivered dose with data on pesticide toxicity.

For hazard assessment, EPA's human health risk assessments rely primarily on 1 Note: As of February, 2006, the Agency was soliciting public comment regarding the use of ¾ body weight scaling in animal to human extrapolations for non cancer risk assessment. If this becomes Agency wide policy in the future, OPP's cumulative risk assessment will appropriately adopt this approach. Page 5 of 19 toxicity related information derived from testing with laboratory animals, but EPA may occasionally receive human data that help characterize the toxicity or kinetics of a pesticide. Regarding exposure, EPA routinely uses data from human research in estimating potential exposure to pesticides. In addition, the Agency may use data from human research to evaluate the efficacy of certain types of pesticides.

The range of types of human research on pesticides is discussed below, followed by a brief discussion of the role of human toxicity studies in pesticide risk assessment.

  Systemic toxicity  Ordinarily, toxicity studies that the Agency receives in support of pesticide registrations are carried out in rodents, rabbits or dogs. Occasionally, human toxicity studies are submitted to support pesticide registration or reregistration, but such studies have never been common, and OPP has never developed guidelines for the conduct of human systemic toxicity studies. It is this kind of study, defined as a study to define or quantify an adverse response in human subjects, which has drawn most attention from those who have criticized the Agency for the use of human data in pesticide regulation. All human systemic toxicity studies of pesticides that support a regulatory decision rendered after April 7, 2006 will be brought to the HSRB for review of science and ethics, even studies conducted decades ago.

  Dermal irritation and dermal sensitization  These studies, typically conducted in rabbits, are commonly received in support of registration of all pesticide products. Studies performed with human subjects are occasionally submitted in support of pesticides, particularly for antimicrobial pesticides intended for home use. For conventional pesticides, data of this sort are not ordinarily used for quantitative risk assessment, but can influence label warnings and other label language. These types of human studies are subject to HSRB review.

  Eye irritation and other sensory threshold studies   Ordinarily, eye irritation studies are performed with rabbits. OPP has recently received a two eye irritation studies on fumigants using human subjects. Occasionally the eye irritation studies are associated with other studies such as odor threshold studies, so these studies may have originally been intended to ascertain whether a product has adequate warning properties. These studies are subject to HSRB review and examples of these types of studies may be presented to the Board in 2006.

  Epidemiology studies  Epidemiology studies are not common. A few studies have been submitted by registrants. These studies are not considered intentional exposure studies and normally will not be submitted for HSRB review.

  Poisoning/ incident data  These studies or reports are also not considered intentional exposure data and normally will not be submitted for HSRB review. Incident reports may serve as a reality check on the risk assessment. Absence of Page 6 of 19 incident reports does not indicate that a pesticide is without risk, but positive data may indicate whether the risk assessment is focused on the key effect. Incident reports are much less useful quantitatively, because it is usually difficult to associate an incident with a measured exposure.

  In vitro studies  Genotoxicity studies with human lymphocytes or in vitro dermal absorption studies with human cadaver skin are examples of in vitro studies of human cells or tissues occasionally submitted to OPP. In vitro studies on human cells or tissues are not considered to be " human research" according to the Human Studies Rule and normally will not be brought to the HSRB for review.

  Absorption, distribution, metabolism, and excretion ( ADME) studies. These studies may be viewed as the interface between toxicity and exposure for they reveal how a chemical presented to a human subject might be transported to the target tissue and transformed to more toxic forms or detoxified to less active forms. Most human studies submitted in this category ( ADME studies) are dermal absorption studies. As is the case with toxicity studies, the Agency neither requires nor encourages the generation of dermal absorption studies in humans and has not developed guidelines for the proper conduct of such studies. These studies may be submitted from the literature or may have been generated by registrants to characterize differences in absorption between humans and animals. On some occasions, the Agency has received comprehensive human ADME data on pesticides, particularly pharmaceuticals. These studies are subject to HSRB review.

Exposure studies   Food consumption patterns ( dietary exposure assessment). OPP dietary exposure assessments rely heavily on dietary survey data collected in food surveys, such as USDA's Continuing Survey of Food Intake by Individuals ( CSFII). As a survey, this sort of information is not considered to be research involving intentional exposure according to the Human Studies Rule and normally will not be brought to the HSRB for review.

  Occupational/ residential handler ( mixer/ loader/ applicator) studies. Whereas human studies are relatively uncommon in assessing potential risks to human health, human studies are critical to the assessment of occupational and residential exposure, and nearly every occupational or residential exposure assessment uses human data either directly or indirectly. Human studies tend to focus on exposures related to pesticide application ( i. e. mixer/ loader/ applicator studies or pesticide handler studies), or post application ( e. g. worker reentry studies). The Office of Pollution Prevention and Toxics has published test guidelines ( Series 875  Occupational and Residential Exposure Test Guidelines) that outline procedures to follow in developing a study protocol. Databases of exposure studies such as the Pesticide Handlers Exposure Database ( PHED) or the Outdoor Residential Page 7 of 19 Exposure Task Force ( ORETF) have been created from pools of exposure studies to provide generic exposure values for assessment of any pesticide whose use is consistent with pesticides in the databases.

Applicator studies have typically employed patches affixed to clothing as dosimeters of exposure or more frequently now, use whole body dosimeters. Post application studies typically measure the amount of pesticide deposited on the skin in human subjects performing tasks, such as plant thinning or harvesting, normally carried out following pesticide application. Another type of exposure study that is being submitted with increasing frequency to OPP is the biomonitoring study. The internal dose is determined from measured levels of a biomarker in urine or blood coupled with knowledge of oral and dermal pharmacokinetics of the pesticide. Review of biomonitoring protocols and studies requires effective collaboration between exposure assessor and a toxicologist knowledgeable about pharmacokinetic studies.

The bulk of exposure studies already submitted to the Agency is interpreted as intentional exposure studies because the study investigators are considered to be in control of at least some of the study parameters ( i. e. the investigator is not completely passive with respect to the conditions of exposure). Intentional exposure studies completed in the past normally will not be submitted to the HSRB for their review, but protocols and studies to be carried out from now on will be brought to the HSRB for review of science and ethics.

Special studies   Insect repellent efficacy  Submitted in support of the registration of insect repellents, these are specialized studies to determine optimal conditions for use of insect repellents. They are considered intentional exposure studies and future protocols and studies will be submitted to the HSRB.

Role of intentional exposure human systemic toxicity studies in pesticide risk assessment.

When a human toxicity study is submitted to the Agency, it is assigned to a toxicologist familiar with the active ingredient. Each study is evaluated according to standard procedures2 which details the factors a toxicologist considers in reviewing individual human studies for their scientific quality and in preparing a weight of evidence analysis. Reviewers focus on factors such as study design, characterization of the tested material, subject selection, adequacy of controls, dose selection, clinical observations and symptoms, statistical analysis, etc. For human studies determined to be scientifically and ethically acceptable, a weight of evidence analysis is undertaken 2 Included in the data package for the first HSRB meeting is a document entitled " Interim Guidance for Judging the Scientific Quality of Intentional Exposure Human Studies Page 8 of 19 whereby human and animal studies are compared with respect to study strengths and weaknesses and pattern of effects. Since the OPP toxicologist is familiar with the whole database on a pesticide, that individual is well suited to judge how human data fits into the overall database, and what its appropriate role in the risk assessment might be.

Human toxicity data could be used in any of the following ways:

  Provide an endpoint and point of departure for risk assessment. If a human study is scientifically sound and the pattern of observed effects is consistent with that observed in experimental animals, the human study might be used directly to establish a point of departure such as a NOAEL, LOAEL or benchmark dose. For some toxicities, the effects observed in human studies are subjective in nature and/ or are difficult to measure in laboratory animals. In these cases, the human study may be relevant for developing points of departure. There may be cases where the results of a human study provide a more sensitive endpoint than any observed in experimental animals  in these cases, the human endpoint may be used for risk assessment.

  Inform the interspecies uncertainty factor. The default interspecies uncertainty factor of 10X assumes that the average adult human may be up to 10 times more sensitive than the most sensitive animal species for a particular toxic response. This default 10X can be modified if quantitative, scientifically sound data comparing the response in humans and the sensitive species are provided ( see footnote 2).

  Inform the intraspecies uncertainty factor. The default intraspecies uncertainty factor of 10X assumes that sensitive subpopulations of humans may be up to 10 times more sensitive than the average human. This assumption can be modified if scientifically sound data comparing the response in such a sensitive subpopulation with average adults were to be submitted. The challenge in this case is to rigorously define such a subpopulation and to demonstrate that no other subpopulation is likely to be more sensitive. This use of human data is expected to be rare for this case.

  Evaluate the relevance of a mechanism or mode of toxic action. Increasingly, OPP is receiving more and more mechanistic and mode of action data on pesticides. It is conceivable that human studies could be performed to characterize that a particular mode of toxicity shown to occur in animals was relevant to humans.

  Develop a physiologically based pharmacokinetic ( PBPK) or biologically based dose response ( BBDR) model. The Agency is increasing its development and use of PBPK and BBDR models. These models may contain in vivo ( metabolism or toxicity) or in vitro data from humans. Page 9 of 19 Summary of the eleven intentional exposure human studies to be reviewed by the HSRB at its April 4 7, 2006 Meeting There are eight different pesticides for which human data are being presented for use in either single chemical or cumulative risk assessments for pesticide reregistration. In all cases, these assessments are required under the FQPA tolerance reassessment program which has a statutory deadline of August 3, 2006. Appendix A is a table that summarizes important details of each of 11 studies to be evaluated in depth by the HSRB: aldicarb ( one study); methomyl ( one); oxamyl ( one); azinphos methyl ( one); dichlorvos, or DDVP ( one); ethephon ( two); amitraz ( three); and hydrogen cyanide ( one). Tables 1 through 3 below present some brief summary information on these studies. In the WOE document for DDVP, OPP has also discussed briefly other intentional exposure human toxicity studies on DDVP on which OPP is not relying. OPP has determined that these DDVP studies are either not scientifically useful for OPP's human health risk assessment or involved intentional exposure of children, and thus are not studies on which EPA is permitted to rely on under the final rule. OPP has made available to the Board copies of each of these studies.

Five of the eight pesticides are members of two common mechanism groups: N methyl carbamates ( aldicarb, methomyl, and oxamyl), and organophosphates ( azinphos methyl and DDVP). In mammals, measurement of acetyl cholinesterases in both red blood cell ( RBC) and brain represent biomarkers of exposure to these chemicals. Ethephon appears to be a potent inhibitor of butylcholinesterase ( found in plasma and often called " pseudocholinesterase"), whereas it does not appear to interact as readily with RBC or brain acetylcholinesterases. The HSRB has received the OPP/ HED ChE Policy to understand how we use such data. The two remaining pesticides ( amitraz and hydrogen cyanide) represent other chemical classes and the effects monitored or observed are generally measurable clinical signs ( vital signs, pulse rate, EKG, blood pressure, etc.) or symptoms that may be more subjective in nature ( headaches, drowsiness, etc.).

The previous section described the various ways for incorporating human toxicity studies into human health risk assessments. For five of the eight pesticides, the human data were used directly to derive the PoD for use in the single chemical human health risk assessment ( azinphos methyl, DDVP, ethephon, amitraz, and hydrogen cyanide) ( Table 1). In one other single chemical risk assessment case ( aldicarb), the human data was used to reduce the interspecies UF. In the remaining two cases ( methomyl and oxamyl), the single chemical risk assessments have already been completed and the human data will be used only for the cumulative assessment for interspecies extrapolation since animal data were used to develop relative potency factors. For cumulative risk assessments, the human data for methomyl and DDVP supported retaining the default 10X interspecies factors; for oxamyl and aldicarb the human data supported reducing the interspecies factor. The azinphos methyl human data are not being used in the cumulative risk assessment. Page 10 of 19 Table 1: Identification of Eight Pesticides and the Associated Human Studies to be Considered at HSRB ( April, 2006)

Pesticide Chemical Class Effects Monitored Study Duration How Used in OPP RA Aldicarb N methyl carbamate Cholinesterase inhibition Acute ( single exposure) Animal data used as PoD 1 for single chemical and relative potency value used for cumulative. Human data used to reduce interspecies UF in both single chemical and cumulative risk assessments 2 Methomyl N methyl carbamate Cholinesterase inhibition Acute ( single exposure) Single chemical assessment previously completed. Animal data used for relative potency value. Human data used to keep interspecies UF of 10X in cumulative risk assessment 2 Oxamyl N methyl carbamate Cholinesterase inhibition Acute ( single exposure) Single chemical assessment previously completed. Animal data used for relative potency value. Human data used to reduce interspecies UF of 10X in cumulative risk assessment 2 Azinphos methyl Organophosphate Cholinesterase inhibition 28 Day Study Human study used as PoD for worker assessment for up to 60 days in single chemical assessment. Animal data used for relative potency value in the cumulative risk assessment 3 , human data were not used to inform the interspecies UF.

DDVP Organophosphate Cholinesterase inhibition 21 Day Study Human study used as PoD for short and intermediate term dermal, incidental oral, and inhalation exposure scenarios in the single chemical assessment. Animal data were used for relative potency in the cumulative risk assessment 3 , human data used to keep the 10X interspecies UF.

Ethephon Organophosphorous compound Adverse events 28 Day Study Human study used as PoD for acute and chronic dietary exposure scenarios.

Amitraz Formamidine Adverse events Three acute studies Human study used as PoD for acute and chronic dietary exposures and for non dietary exposure scenarios of various durations.

Hydrogen cyanide 4 Nitrile Adverse events Multiple days of oral exposure ( exact number not specified) Human study used as PoD for acute dietary exposure.

1 PoD = Point of Departure. 2 N methyl carbamate cumulative risk assessment. 3 Organophosphate cumulative risk assessment. 4 Formed during use of sodium cyanide as a fumigant. Page 11 of 19 Table 2 provides information about study design for each of the 11 studies. Again, Appendix A has more details. Five of the 11 studies were performed between 1997 and 1999; with the remaining six being run from 1972 to 1992. The majority of the studies ( 8/ 11) were conducted in the United Kingdom, with the remainder occurring in the U. S.

The total number of human volunteers ranged from a low of two ( amitraz metabolism study) to a high of 178 ( cancer patients in the hydrogen cyanide study). However, the nine studies between these extremes ranged from having six to 47 volunteers. In addition to this spread in the number of human volunteers across the studies, a majority ( 7/ 11) used male volunteers only. In three of the four cases where female volunteers were used, the number of females was lower than the number of males, the exception being the 1972 ethephon study.

Table 2: General Information on Human Volunteer Studies for HSRB ( April, 2006) ( All Studies are Via the Oral Route Unless Otherwise Noted)

Pesticide Study Year No. of Males1 No. of Females1 Laboratory Aldicarb 1992 38 9 Methomyl 1998 19 None Oxamyl 1999 40 None Azinphos methyl 1999 12 None Inveresk ( Scotland)

DDVP 1997 9 None Medeval, ( UK) 1972 8 8 Ethephon 1977 16 14 Litton ( US)

1998 2 8 1992 6 Simbec ( UK) Amitraz 1984 2 None FBC ( UK)

Hydrogen cyanide 1982 100 78 Cancer patients from four different cancer centers in US. 1 Includes control/ placebo group. 2 Dermal study. Page 12 of 19 Most of the studies presented ( 10/ 11) involved oral exposure ( Table 3). In most of these cases the test material was delivered in a capsule with a liquid during or after a meal. The single dermal study ( amitraz), divided the total intended daily dose into four equal parts and applied them to the forearm of male volunteers every 2.5 hours for 10 hours over two days.

Approximately half of the studies ( six) involved acute exposure conditions ( one or two days of exposure), four used repeated dose exposure conditions ( daily oral exposures from 16 to 28 days), and in one ( hydrogen cyanide) case, the duration of exposure via the oral route was unclear.

The methods used to employ placebo groups varied among the 11 studies ( Table 3). In six studies, a separate group of volunteers was used ( methomyl, oxamyl, azinphosmethyl DDVP, and in both ethephon studies). Aldicarb had a subset of volunteers ( six males and five females) that received both a placebo and treatment capsule as part of the study design. Two of the three amitraz studies ( the acute dermal and acute oral studies) used a crossover design in which each of the volunteers on study were given a placebo and each treatment exposure over the course of the study. In both cases, the time period between treatments was 14 days. The third amitraz study was a metabolism study in which radiolabeled amitraz was given orally to two male volunteers and there was no placebo group. Finally, the hydrogen cyanide study was a clinical trial without a placebo group. All volunteers were given amygdalin ( Laetrile) at one of two doses and monitored for an unspecified period of time.

Summary At the first meeting of the Human Studies Review Board, the Office of Pesticides Programs is soliciting comments from the Board on science and ethics reviews of human studies involving intentional exposure and systemic toxic effects, as well as weight of evidence documents on a number of pesticides for which registrants have submitted human studies. The risk assessment teams for the pesticides have reviewed the human and animal data and have proposed endpoints for risk assessment based on the totality of the data for each pesticide. In some instances, the risk assessment teams have proposed using human studies directly with interspecies factors reduced to 1x. In other instances, the human studies are used to adjust the interspecies factor and in some cases the human studies are considered not to be useful at all for endpoint selection. An ethical review has also been conducted on each of the human studies relied upon for endpoint selection.

The HSRB is asked to comment on the weight of evidence discussions for each of the pesticides with respect to the quality of the science underlying the discussions and the quality of the ethics reviews which have been prepared for each of the human studies under consideration. Page 13 of 19 Table 3: Study Duration, Number of Exposures, and Exposure Method for Human Volunteer Studies Considered at HSRB ( April, 2006) Pesticide Study Duration No. of Exposures Exposure Method Comments Aldicarb Oral, single exposure Five plus placebo ( males) and Two plus placebo ( females) In orange juice with breakfast Six males and five females participated in placebo and treatment session.

Methomyl Oral, single exposure Three plus placebo ( males only)

Oxamyl Oral, single exposure Six plus placebo ( males only) Double blind, ascending dose escalation trial.

Azinphos methyl Oral, repeated exposure ( 28 days) One plus placebo ( males only) Gelatin capsule five minutes after breakfast.

No effects observed.

DDVP Oral, repeated exposure ( 21 days) One plus placebo ( males only) Capsule taken with water after overnight fast No comments.

Oral, repeated exposure ( 28 days) No comments.

Ethephon Oral, repeated exposure ( 16 days) One plus placebo ( males and females) Capsule   3X/ day; first two after a meal and the third at the end of the work day No effects observed.

Dermal, acute ( two days) Three plus placebo ( males only) Four equal exposures applied dermally every 2.5 hours for 10 hours for two days.

Oral, single exposure Two plus placebo ( males only) Capsule taken 30 minutes after breakfast with water. Randomized crossover design. Each person received all doses   exposures separated by 14 days. Amitraz Oral, single exposure One, no placebo ( males only) Capsule; possible light breakfast eaten two hours prior to exposure. Metabolism study with two human volunteers

Hydrogen cyanide Oral, repeated exposure Two, no placebo ( males and females) Oral exposure given either three or four times/ day Exact duration of exposure difficult to determine. Page 14 of 19 References: Mileson, B. Chambers, J. E., Chen, W. L., Dettbarn, W., Ehrich, M., Eldefrawi, A. T., Gaylor, D. W., Hammernik, K., Hodgson, E., Karczmar, A. G., Padilla, S., Pope, C. N., Richardson, R. J., Saunders, D. R., Sheets, L. P., Sultatos, L. G., and Wallace, K. B. 1998. Common Mechanism of Toxicity: a case of organophosphorus pesticides. Toxicological Sciences 41, pp. 8 20.

National Research Council ( NRC). 1983. Risk Assessment in the Federal Government: Managing the Process. Washington, DC.: National Academy Press.

National Research Council ( NRC). 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC.: National Academy Press.

USEPA. 1994. Methods for Derivation of Inhalation Reference Concentrations and Applications of Inhalation Dosimetry. EPA/ 600/ 8 90/ 066F. Office of Research and Development, Washington DC.

USEPA, 1999a. Guidance for Identifying Pesticide Chemicals and Other Substances that Have a Common Mechanism of Toxicity, www. epa. gov/ fedrgstr/ EPA PEST/ 1999/ Februrary/ Day 05/ o p2781. htm USEPA, 1999b. " A Science Policy on a Common Mechanism of Toxicity: The Carbamate Pesticides and the Grouping of Carbamate with the Organophosphorus Pesticides;" draft document. August 30, 1999. http:// www. epa. gov/ scipoly/ sap/ 1999/ september/ carbam. pdf USEPA. ( 2000). " Benchmark Dose Technical Guidance Document" Draft report. Risk Assessment Forum, Office of Research and Development, U. S. Environmental Protection Agency. Washington, DC. EPA USEPA 2001a. " General Principles for Performing Aggregate Exposure and Risk Assessments." Final. December 2, 2001. Office of Pesticide Programs, Office of Prevention, Pesticides, and Toxic Substances, US Environmental Protection Agency. Washington, DC. Available: http:// www. epa. gov/ oppfead1/ trac/ science/

USEPA 2001b. Memorandum from Marcia Mulkey to Lois Rossi. " Implementation of the Determinations of a Common Mechanism of Toxicity for N Methyl Carbamate Pesticides and for Certain Chloroacentanilide Pesticides." July 12, 2001. http:// www. epa. gov/ oppfead1/ cb/ cab_ page/ updates/ carbmate. pdf USEPA, 2002. " Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity." January 14, 2002. ( 67 FR 2210; January 16, 2002) http:// www. epa. gov/ oppfead1/ trac/ science/# common USEPA ( 2002a) A Review of the Reference Dose and Reference Concentration Processes. U. S. EPA, Risk Assessment Forum, Washington, DC, EPA/ 630/ P 02/ 002F, 2002. Page 15 of 19 APPENDIX A: SUMMARY OF ELEVEN INTENTIONAL EXPOSURE HUMAN STUDIES FOR HSRB ( April, 2006)

Pesticide and MRID No. Study Objective Endpoint Measured & Exp.

Route Doses Used No. of Males ( By Dose) No. of Females ( By Dose) Exposure Method Timing of observation &/ or blood draw Adverse events noted? NOAEL, LOAEL & Benchmark Dose ( BMD, if calculated)

Aldicarb 42373001 " 1. Determine the general tolerance of human volunteers ( both males and females) to a range of doses of aldicarb.

2. Provide cholinesterase determination on red blood cells and separated plasma." ChE inhibition ( RBC, plasma) and clinical signs.

Oral, single exposure Males: 0, 0.01,

0.025, 0.05,

0.06, 0.075 mg/ kg. Females: 0,

0.025, 0.05 mg/ kg. Total: 38 ( 16 placebo,

and 8, 8, 8,

1, 5 for low to high dose groups) Total: 9 ( 6 placebo and 4/ dose) In orange juice with breakfast At post exposure times of 1, 2, 3, 4, 5,

6, 24 hours Sweating observed in males at 0.025 mg/ kg. No overall NOAEL identified ( see WOE).

Male NOAEL = 0.01 mg/ kg Male LOAEL =

0.025 mg/ kg [ plasma 36%; RBC 12%];

Female NOAEL = not est. Female LOAEL = 0.025 mg/ kg,

plasma ChEI 50%;

RBC 20%]

( BMD10   0.02 mg/ kg;

BMDL10 = 0.01 mg/ kg).

Methomyl 44721401 "  to determine the no   observableadverse effect level ( NOAEL) for methomyl in humans after oral administration ChE inhibition ( RBC, plasma) and clinical signs.

Oral, single exposure 0, 0.1, 0.2, 0.3 mg/ kg ( 0.5 mg/ kg dropped) Total: 19 ( 4 placebo and 5/ dose) None Gelatin capsule five minutes after " stand ard"

breakfast Screening,  16 hrs,

 30 mins., every 15 mins to 2 hrs, hourly to 8 hrs, 24 hrs, 7 days Physiol. Parameters: pulse,

resp. rate,

salivation, pupillary responses. One male ( 0.3)  transient head ache,

early inc. in salivation NOAEL = not est.

LOAEL= 0.1 mg/ kg,

decreased peak RBC ChE activity ( 19%)

( BMD10   0.035 mg/ kg; BMDLL10=

0.015 mg/ kg). Page 16 of 19 Pesticide and MRID No. Study Objective Endpoint Measured & Exp.

Route Doses Used No. of Males ( By Dose) No. of Females ( By Dose) Exposure Method Timing of observation &/ or blood draw Adverse events noted? NOAEL, LOAEL & Benchmark Dose ( BMD, if calculated)

Oxamyl 44912301 "  to determine the no   observableadverse effect level ( NOAEL) for oxamyl in humans after oral administration." ChE inhibition ( RBC, plasma)

Oral, single exposure 0, 0.005, 0.015,

0.03, 0.06, 0.09,

0.15 mg/ kg Total: 40 ( 10 placebo and 5/ dose) None Gelatin capsule five minutes after " standard"

breakfast ChE assays

Screening,

2days,  16hrs,

 30mins, every 15 mins to 2hrs, 3hrs,

4, 6, 8, 12, 24hrs, 7 days Physiol. Parameters: pulse,

resp. rate,

salivation, pupillary responses. No treatment related clinical signs NOAEL = 0.06 mg/ kg 7 12% decreased plasma & RBC ChE @ 0.09 mg/ kg ( BMD10   0.083 mg/ kg; BMDL10 =

0.069 mg/ kg).

Azinphos methyl 45476101 " To determine the no effect level for plasma and RBC cholinesterase after repeated exposure and to compare the human and animal sensitivities at no effect levels." ChE inhibition ( RBC, plasma)

Oral, repeated exposure ( daily for 28 days) 0, and 0.25 mg/ kg/ day Total: 12 ( 4 placebo and 8 treated) None Gelatin capsule five minutes after " standard"

breakfast ChE assays

Screening,

14,  12,  10,  8,  6,

4, and  1 days.

Then daily after exposure for 28 days ( on 12 of these days, two blood samples taken

before exposure and 4hours post exposure).

Clin obs and selfreporting of symptoms. None observed. NOAEL set at 0.25 mg/ kg/ day but since no effects on ChE, no LOAEL established. Page 17 of 19 Pesticide and MRID No. Study Objective Endpoint Measured & Exp.

Route Doses Used No. of Males ( By Dose) No. of Females ( By Dose) Exposure Method Timing of observation &/ or blood draw Adverse events noted? NOAEL, LOAEL & Benchmark Dose ( BMD, if calculated)

DDVP 44248801 "  assess inhibition of erythrocyte cholinesterase following multiple oral doses of dichlorvos." RBC ChE inhibition Oral, repeated exposure ( daily for 21 days) 0 and 7 mg/ adult male ( 0.1 mg/ kg/ day) Total: 9 ( 3 placebo,

6 treated) None Dissolved in corn oil, put in capsule and taken with 150 mL water after overnight fast. ChE assays

Screening,

14,  12,  10,  7,  5,

3 days and immed.

pre dose. Then on days 2, 4, 7, 9, 11,

14, 16, 18 just before exposure for 21 days ( and day 25 and 28 postexposure

Self reported symptoms None considered treatment related LOAEL = 0.1 mg/ kg/ day ( up to 16% RBC ChEI)

Ethephon 36510 " Evaluation of compound effect on cholinesterase activity in human plasma and red blood cells following repeated daily doses." RBC/ Plasma ChEI, clin.

chem. , and urinal.

Oral, repeated exposure ( daily for 28 days) 0 and 1.8 mg/ kg/ day ( ave.

dose for males and females) for 28 consecutive days Total: 8 ( 3 placebo,

5 treated). Total: 8 ( 3 placebo,

5 treated) Orally by capsule and divided into three doses each day   the first two after a meal and the third at end of work day. Hematology, clinical chem., urinalysis on Day 1, 7, 14, 21, 28 and two weeks after last exposure.

ChE anal. used modified Michel method. Gastrointestinal distress ( incl.

diarrhea) and inc. urgency and freq. of urination LOAEL = 1.8 mg/ kg/ day; One dose tested Ethephon 66931 "  to further evaluate the bioeffects of Ethephon on human volunteers with regard to plasma and red blood cell cholinesterase activity , other biochemical parameters and subjective clinical observations." RBC/ Plasma ChEI, clin.

chem. , and urinalysis Oral, repeated exposure ( daily for 16 days) 0 and 0.5 mg/ kg/ day for 16 days, followed by 29 day recovery period.

Daily dose given in three periods in the morning and evening Total: 16 ( 6 placebo,

10 treated). Total: 14 ( 4 placebo,

10 treated). Orally by capsule and divided into three doses each day   the first two after a meal and the third at end of work day. Hematology, clinical chem., urinalysis on Day 4, 8, 12, 16 during exposure period and Days 15 and 29 after last exposure.

ChE anal. used modified Michel method. No symptoms reported; questionable ChEI results Not determined.

Considered contrary to 1972 findings Page 18 of 19 Pesticide and MRID No. Study Objective Endpoint Measured & Exp.

Route Doses Used No. of Males ( By Dose) No. of Females ( By Dose) Exposure Method Timing of observation &/ or blood draw Adverse events noted? NOAEL, LOAEL & Benchmark Dose ( BMD, if calculated)

Amitraz 44639401 "  to determine the tolerance in human volunteers and establish a no effect dose level for acute pharmacological effects following administration of repeated dermal doses of Amitraz " Adverse events, psychomotor activity, vital signs, clin.

chem. Dermal, eight doses over two days Total dose of 0,

8, 16 or 24 mg/ kg Total: 8 ( Each person received placebo and each dose for two days  applications were separated by seven days.) None Aqueous 1: 1 slurry; placebo: starch ( 1: 1) water.

Each person rec'd 4 equal doses over 10 hrs. for two days. Vital signs: predose  1,  0.5 hrs;

postdose: 3, 6, 12,

24, 36 hrs; ECG:

predose:  1;

postdose: 3, 6, 12,

24, 36 hrs. Psychomotor:

predose   0.5 hr;

post dose   5 and 10 hr. Hemato/ clin chem./ urin   36 hr after first dose No treatment related events NOAEL: 24 mg/ kg/ day; LOAEL:

not established Amitraz 43283101 "  to determine the general tolerance of male volunteers to two single doses of amitraz spaced 2 3 weeks apart and to determine the noeffect level ( NOEL)." Vital signs,

pupil response, psychomotor performance

Oral, single exposure 0, 0.625, 0.125 mg/ kg Total: 6 Each person received placebo and each dose. Doses separated by 14 days. None In capsule with lactose taken 30 minutes after breakfast with water. Vital signs:  1,  0.5,

1, 3, 6, 12, 24, & 36 hrs ECGs:  1, 1, 3, 6,

12, 24 & 36 Pupil response psychometric performance:

predose & 2.5 & 8 hrs No treatment related events NOAEL: 0.125 mg/ kg/ day; LOAEL:

not established Page 19 of 19 Pesticide and MRID No. Study Objective Endpoint Measured & Exp.

Route Doses Used No. of Males ( By Dose) No. of Females ( By Dose) Exposure Method Timing of observation &/ or blood draw Adverse events noted? NOAEL, LOAEL & Benchmark Dose ( BMD, if calculated)

Amitraz 00160964;

46249601 00160964   "  the metabolism of amitraz in rats, mice,

baboons, and humans." 46249601   "  an investigation of the urinary excretion of [ 14C] amitraz by male human volunteers." Clinical signs.

( Purpose of study was to assess metabolism)

Oral, single exposure ( radiolabeled) 0.25 mg/ kg 14Camitraz Total: 2 ( No placebo group) None Crystalline amitraz in gelatin capsules Volunteers were " instructed" to eat a light breakfast two hours prior to exposure. Vital signs and observation up to 12 hrs; urinalysis up to 72 hours. Dry mouth, drowsiness, disorientation,

decreased temperature,

bradycardia,

slightly pale appearance in both volunteers for up to several hours postexposure LOAEL: 0.25 mg/ kg;

no NOAEL established Hydrogen Cyanide ( HCN) 46769602 "  a clinical trial of amygdalin for the treatment of advanced cancer." Possible cancer therapeutic agent.

I ntravenous and oral doses of amygdalin;

oral doses evaluated ( duration not specified). Standard   4.5 g/ m2 x 21 days iv followed by 0.5 g orally three times/ day.

High   7 g/ m2 x 21 days iv followed by 0.5 g orally four times/ day NOTE: Each oral dose of amygdalin ( 0.5 g) is equivalent to ~ 0.4 mg/ kg/ d HCN. Total: 100 ( 92 standard and 8 high dose) Total: 78 ( 72 standard and 6 high dose) Intravenous dose given for 21 days and then oral tablets given until cancer progression worsened Blood drawn for CN analysis: after iv course, 48 hrs. after first oral dose, and then two hours after first oral daily dose. Headache,

dizziness,

nausea, vomiting, loss of mental acuity. ( After one or two oral doses;

especially if taken together to compensate for a missed dose. Standard oral dose considered a NOAEL ( 0.4 mg/ kg).


[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46607-46608]
[FR Doc No: 2017-21455]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0123; FMCSA-2014-0124]

Qualification of Drivers; Exemption Applications; Hearing

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions for three
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on April 8, 2017. The exemptions
expire on April 8, 2019.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On April 5, 2017, FMCSA published a notice announcing its decision
to renew exemptions for three individuals from the hearing standard in
49 CFR 391.41(b)(11) to operate a CMV in interstate commerce and
requested comments from the public (82 FR 16661). The public comment
period ended on May 5, 2017 and one comment was received.
    As stated in the previous notice, FMCSA has evaluated the
eligibility of these applicants and determined that renewing these
exemptions would achieve a level of safety equivalent to or greater
than the level that would be achieved by complying with the current
regulation 49 CFR 391.41(b)(11).
    The physical qualification standard for drivers regarding hearing
found in 49 CFR 391.41(b)(11) states that a person is physically
qualified to driver a CMV if that person:

    First perceives a forced whispered voice in the better ear at
not less than 5 feet with or without the use of a hearing aid or, if
tested by use of an audiometric device, does not have an average
hearing loss in the better ear greater than 40 decibels at 500 Hz,
1,000 Hz, and 2,000 Hz with or without a hearing aid when the
audiometric device is calibrated to American National Standard
(formerly ASA Standard) Z24.5-1951.

    49 CFR 391.41(b)(11) was adopted in 1970, with a revision in 1971
to allow drivers to be qualified under this standard while wearing a
hearing aid, 35 FR 6458, 6463 (April 22, 1970) and 36 FR 12857 (July 3,
1971).

III. Discussion of Comments

    FMCSA received one comment in this preceeding. Janet S. Pratcher
from the University of Memphis, Department of Social Work, wrote in
support of renewing the exemptions for the three individuals in this
notice for two years.

IV. Conclusion

    Based upon its evaluation of the three renewal exemption
applications and comment received, FMCSA announces its' decision to
exempt the following drivers from the hearing requirement in 49 CFR
391.41(b)(11).
    As of April 8, 2017, and in accordance with 49 U.S.C. 31136(e) and
31315, the following three individuals have satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate (CMV) drivers (79 FR 90336; 80 FR 18926; 81
FR 12556): Clark Dobson (CA); Gregory Hill (MS); and Ronald Ruttler
(WA).
    The drivers were included in docket numbers FMCSA-2012-0123 and
FMCSA-2014-0124. Their exemptions were applicable as of April 8, 2017,
and will expire on April 8, 2019.
    In accordance with 49 U.S.C. 31315, each exemption will be valid
for two years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than

was maintained prior to being granted; or (3) continuation of the
exemption would not be consistent with the goals and objectives of 49
U.S.C. 31136 and 31315.

    Issued on: September 19, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-21455 Filed 10-4-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 86, Number 241 (Monday, December 20, 2021)]
[Notices]
[Pages 71904-71905]
[FR Doc No: 2021-27405]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2010-0164]

National Boating Safety Advisory Committee; January 2022
Teleconference

AGENCY: U.S. Coast Guard, Department of Homeland Security.

ACTION: Notice of Federal Advisory Committee teleconference meeting.

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SUMMARY: The National Boating Safety Advisory Committee (Committee)
will meet via teleconference to discuss matters relating to
recreational boating safety. This meeting will be open to the public.

DATES: Meeting: The Committee will meet by teleconference on Thursday,
January 20, 2022, from 12:00 p.m. until 4:00 p.m., (Eastern Standard
Time). The teleconference may adjourn early if the Committee has
completed its business.
    Comments and supporting documentation: To ensure your comments are
received by Committee members before the teleconference, submit your
written comments no later than January 17, 2022.

ADDRESSES: To join the teleconference or to request special
accommodations, contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section no later than 1 p.m. on January 17, 2022,
to obtain the needed information. The number of teleconferences lines
is limited and will be available on a first-come, first-served basis.
    Instructions: You are free to submit comments at any time,
including orally at the teleconference as time permits, but if you want
Committee members to review your comments before the teleconference,
please submit your comments no later than January 17, 2022. We are
particularly interested in comments on the issues in the ``Agenda''
section below. We encourage you to submit comments through the Federal
eRulemaking Portal at https://www.regulations.gov. If your material
cannot be submitted using https://www.regulations.gov, call or email
the individual in the FOR FURTHER INFORMATION CONTACT section of this
document for alternate instructions. You must include the docket number
[USCG-2010-0164]. Comments received will be posted without alteration
at http://www.regulations.gov, including any personal information
provided. For more about privacy and submissions in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020). If you encounter technical difficulties with comment
submission, contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section of this notice.
    Docket Search: Documents mentioned in this notice as being
available in the docket, and all public comments, will be in our online
docket at https://www.regulations.gov and can be viewed by following
that website's instructions.

FOR FURTHER INFORMATION CONTACT: Mr. Jeff Decker, Alternate Designated
Federal Officer of the National Boating Safety Advisory Committee, 2703
Martin Luther King Jr. Ave SE, Stop 7509, Washington, DC 20593-7509,
telephone<PHONE_NUMBER> or via email at [email protected].

SUPPLEMENTARY INFORMATION: Notice of this meeting is given pursuant to
the Federal Advisory Committee Act, (5 U.S.C. Appendix). The National
Boating Safety Advisory Committee was established on December 4, 2018,
by Sec.  601 of the Frank LoBiondo Coast Guard Authorization Act of
2018 (Pub. L. 115-282, 132 Stat. 4192). That authority is codified in
46 U.S.C. 15105. The Committee operates under the provisions of the
Federal Advisory Committee Act (5 U.S.C. Appendix) in addition to the
administrative provisions for the National Maritime Transportation
Advisory Committees in 46 U.S.C. 15109. The National Boating Safety
Advisory Committee provides advice and recommendations to the
Department of Homeland Security on matters relating to recreational
vessels and associated equipment and on other safety matters related to
recreational vessels.

Agenda

    The agenda for the National Boating Safety Advisory Committee
meeting is as follows:

Thursday, 20 January 2022

(1) Call to Order.
(2) Roll call of Committee Members and Determination of Quorum.
(3) Opening Remarks.
(4) Swearing-in of New Appointees.
(5) Conflict of Interest Statement.
(6) Receipt and Discussion of the Following Reports From the Office of
Auxiliary and Boating Safety:
    (a) Boating Incident Reporting Policy.
    (b) Strategic Planning Wrap-up.
    (c) Update on Throwable Personal Flotation Device Exemption.
    (d) New Fire Protection Regulation for Recreational Vessels.
(7) Public Comment.
(8) Report From Strategic Planning Subcommittee.
(9) Report From Prevention Through People Subcommittee.
(10) Committee Discussion on Subcommittee Recommendations.
(11) Closing Remarks/Plans for Next Meeting.
(12) Adjournment of Meeting.
    A copy of all meeting documentation will be available at: https://homeport.uscg.mil/missions/federal-advisory-committees/national-boating-safety-advisory-committee-(nbsac)/committee-meetings/fr-
meeting-announcement no later than January 17, 2022. Alternatively, you
may contact Mr. Jeff Decker as noted in the FOR FURTHER INFORMATION
section above.
    During the January 20, 2022 teleconference, a public comment

period will be held from approximately 1:45 p.m.-2:00 p.m. Public
comments will be limited to two minutes per speaker. Please note that
the public comment periods will end following the last call for
comments.
    Please contact the individual listed in the FOR FURTHER INFORMATION
CONTACT section, to register as a speaker.

    Dated: December 14, 2021.
Wayne R. Arguin, Jr.,
Captain, U.S. Coast Guard, Director of Inspections and Compliance.
[FR Doc. 2021-27405 Filed 12-17-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 185 (Monday, September 24, 2012)]
[Notices]
[Pages 58824-58826]
[FR Doc No: 2012-23428]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-520-000]

Gulf Shore Energy Partners, LP; Notice of Intent To Prepare an
Environmental Assessment for the Proposed Markham Booster Station
Project and Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Markham Booster Station
Project involving construction and operation of facilities by Gulf
Shore Energy Partners, LP (Gulf Shore) in Matagorda County, Texas. The
Commission will use this EA in its decision-making process to determine
whether the project is in the public convenience and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the project. Your input will help the Commission staff
determine what issues they need to evaluate in the EA. Please note that
the scoping period will close on October 17, 2012.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves the project, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings where compensation would be determined in accordance with
state law.
    Gulf Shore provided landowners with a fact sheet prepared by the
FERC entitled ``An Interstate Natural Gas Facility On My Land? What Do
I Need To Know?''. This fact sheet addresses a number of typically-
asked questions, including the use of eminent domain and how to
participate in the Commission's proceedings. It is also

available for viewing on the FERC Web site (www.ferc.gov).

Summary of the Proposed Project

    Gulf Shore proposes to acquire a 5-foot-long segment of existing
12-inch-diameter pipeline from Dominion South Pipeline Company, LP
(Dominion) near Markham, Texas and construct and operate a booster
compressor station. The pipeline segment currently interconnects with
the systems of Transcontinental Gas Pipe Line Company, LLC (Transco)
and Florida Gas Transmission Company, LLC (Florida Gas). The Markham
Booster Station Project would be installed on this pipeline segment to
facilitate the firm flow of natural gas from Transco to Florida Gas.
The booster compressor station would boost the gas pressure by
approximately 100 pounds per square inch to allow gas to flow. The
station would only be operated on occasion when the pressure
differential in the pipelines connected to Gulf Shore is near zero.
    The Markham Booster Station Project would consist of the following
facilities:
     An 800-horsepower booster compressor station;
     Associated piping; and
     An access road.
    The general location of the project facilities is shown in appendix
1.\1\
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE., Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the last page of this notice.
---------------------------------------------------------------------------

Land Requirements for Construction

    Construction of the proposed facilities would disturb about 0.5
acre of land for the booster compressor station and associated access
road. Following construction, Gulf Shore would maintain the 0.5 acre
for permanent operation of the project's facilities, including 0.4 acre
(180-foot by 100-foot) for the booster compressor station and 0.1 acre
for the access road.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\2\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping.'' The main goal of
the scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
---------------------------------------------------------------------------

    \2\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed project under these
general headings:
     Geology and soils;
     Land use;
     Water resources, fisheries, and wetlands;
     Cultural resources;
     Vegetation and wildlife;
     Air quality and noise;
     Endangered and threatened species; and
     Public safety.
    We will also evaluate reasonable alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before making our recommendations
to the Commission. To ensure we have the opportunity to consider and
address your comments, please carefully follow the instructions in the
Public Participation section beginning on page 4.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues of
this project to formally cooperate with us in the preparation of the
EA.\3\ Agencies that would like to request cooperating agency status
should follow the instructions for filing comments provided under the
Public Participation section of this notice.
---------------------------------------------------------------------------

    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
---------------------------------------------------------------------------

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the Texas State Historic Preservation Office (SHPO), and to
solicit its views and those of other government agencies, interested
Indian tribes, and the public on the project's potential effects on
historic properties.\4\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPO as the project
develops. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
construction right-of-way, contractor/pipe storage yards, compressor
stations, and access roads). Our EA for this project will document our
findings on the impacts on historic properties and summarize the status
of consultations under section 106.
---------------------------------------------------------------------------

    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. The more specific
your comments, the more useful they will be. To ensure that your
comments are timely and properly recorded, please send your comments so
that the Commission receives them in Washington, DC on or before
October 17, 2012.
    For your convenience, there are three methods which you can use to
submit your comments to the Commission. In all instances please
reference the project docket number (CP12-520-000) with your
submission. The Commission encourages electronic filing of comments and
has expert staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for interested persons to
submit brief, text-only comments on a project;
    (2) You can file your comments electronically using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by

clicking on ``eRegister.'' You must select the type of filing you are
making. If you are filing a comment on a particular project, please
select ``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed project.
    If we publish and distribute the EA, copies will be sent to the
environmental mailing list for public review and comment. If you would
prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the User's Guide under the ``e-filing'' link on the Commission's Web
site.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP12-
520). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/esubscribenow.htm.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: September 17, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-23428 Filed 9-21-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 3, 2009 (Volume 74, Number 147)]
[Notices]
[Page 38426]
[DOCID:fr03au09-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 1

July 27, 2009.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP09-838-000.
    Applicants: Questar Pipeline Company.
    Description: Questar Pipeline Company submits Thirteenth Revised
Sheet No 1 et al. to its FERC Gas Tariff, First Revised Volume No 1.
    Filed Date: 07/22/2009.
    Accession Number: 20090722-0144.
    Comment Date: 5 p.m. Eastern Time on Monday, August 3, 2009.

    Docket Numbers: RP09-839-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Transcontinental Gas Pipe Line Company, LLC submits
Third Revised Sheet 24 to its FERC Gas Tariff, Fourth Revised Volume 1,
to be effective 8/1/09.
    Filed Date: 07/22/2009.
    Accession Number: 20090722-0148.
    Comment Date: 5 p.m. Eastern Time on Monday, August 3, 2009.

    Docket Numbers: RP09-840-000.
    Applicants: Questar Overthrust Pipeline Company.
    Description: Questar Overthurst Pipeline Company's submits its
Annual Fuel Reimbursement Report and Variance Adjustment Calculations
for the period ended 5/31/09.
    Filed Date: 07/24/2009.
    Accession Number: 20090724-0097.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 5, 2009.

    Docket Numbers: RP09-841-000.
    Applicants: Tuscarora Gas Transmission Company.
    Description: Tuscarora Gas Transmission Company submits First
Revised Sheet 4 et al. to FERC Gas Tariff, Original Volume 1 to reflect
the requirements of Order 712.
    Filed Date: 07/24/2009.
    Accession Number: 20090724-0099.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 5, 2009.

    Docket Numbers: CP09-448-000.
    Applicants: Columbia Gulf Transmission Company.
    Description: Columbia Gulf Transmission Company submits an
abbreviated application for permission and approval to abandon natural
gas service (Rate Schedule X-99).
    Filed Date: 07/23/2009.
    Accession Number: 20090723-5076.
    Comment Date: 5 p.m. Eastern Time on Tuesday, August 4, 2009.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    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 should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-18501 Filed 7-31-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 123 (Tuesday, June 26, 2012)]
[Notices]
[Page 38050]
[FR Doc No: 2012-15486]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL12-75-000]

Pepco Holdings, Inc.; Notice of Petition for Limited Waiver

    Take notice that on June 15, 2012, pursuant to Rule 207(a)(5) of
the Rules of Practice and Procedure of the Federal Energy Regulatory
Commission (Commission), Pepco Holdings, Inc. (PHI) filed a petition
for limited waiver concerning the Commission's affiliate transaction
pricing rules, established by Order Nos. 707 and 707-A, for sales of
non-power goods and services. PHI requests waivers of 18 CFR 35.44(b)
so that it may use ``at cost'' pricing for a limited set of
transitions, as more fully described in the filing.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    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 should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Friday, July 6, 2012.

    Dated: June 19, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-15486 Filed 6-25-12; 8:45 am]
BILLING CODE 6717-01-P