APPENDIX J MODELING PROTOCOL SAN ANTONIO EAC REGION ATTAINMENT DEMONSTRATION MARCH 2004 J 2 Appendix J Table of Contents Page List of Tables                              .. J 3 List of Figures                              . J 3 Modeling/ Analysis Protocol                        .. J 4 Part 1: Protocol Overview                         . J 4 Lead Agency                           .. J 4 Stakeholders Participating in the Process               . J 4 Public Participation                          J 7 Management/ Communication Procedures                J 7 Choice of Air Quality Simulation Model and how it Meets Requirements in 40CFR51, Appendix W for using Alternative Models         J 14 Rationale for Choice of Air Quality and Emissions Models and Choice of Method for Generating Meteorological Inputs           .. J 14 Identification of Specific Deliverables and Schedule for Delivery to the Appropriate U. S. EPA Regional Office                 J 15 Data Access                           .. J 16 Other Protocol Topics                       .. J 16 References                            . J 18 Part 2: Modeling Protocol Prepared by ENVIRON International Corporation    J 20 J 3 Appendix J List of Tables Page Table J 1 Executive ( voting) Members of AIR Committee         .. J 5 Table J 2 Public Meetings Conducted in the SAER Counties        . J 11 Table J 3 Schedule of Deliverables to U. S. EPA Region 6         . J 15 Table J 4 Data Access Protocol                    .. J 16 Table J 5 Modeling/ Analysis Protocol Steps Described elsewhere in SIP  . J 17 List of Figures Figure J 1 Flowchart of Communication Process of the Air Improvement Resources ( AIR) Committees                 . J 9 J 4 MODELING/ ANALYSIS PROTOCOL The modeling/ analysis protocol serves numerous functions including: ( 1) identifying the local ( lead) air quality agency assisting the State with attainment analyses, ( 2) identifying methods and procedures used to support the demonstration, and ( 3) describing the review process applied to steps in the demonstration process ( EPA, 1999). Although the protocol serves other functions, one of the most important is providing a means of planning and communicating the procedures to be used for demonstrating attainment.

Appendix J is divided into two parts. The first, Protocol Overview, lists key issues that are addressed in the local modeling/ analysis protocol and describes the means used to fulfill protocol requirements. Part two of this appendix consists of the Modeling Protocol document provided to AACOG by ENVIRON International Corporation for development of the 1999 photochemical model.

PART 1: PROTOCOL OVERVIEW Lead Agency The local ( or lead), agency assists the State with evaluating the analyses needed to support a defensible demonstration. For purposes of the SAER attainment demonstration, the lead agency is the Alamo Area Council of Governments ( AACOG). Although AACOG is the local agency charged with emissions inventory development, photochemical model development, and other major components of the SAER attainment demonstration, the agency works closely with the state ( Texas Commission on Environmental Quality) and federal ( US Environmental Protection Agency) governments to ensure compliance with applicable guidance and regulations.

Stakeholders Participating in the Process Local stakeholders participating in the protocol process include the Air Improvement Resources ( AIR) Committee of the Alamo Area Council of Governments. Formed in April 1999, the mission of the AIR Committee is twofold: ( 1) facilitate the completion of the air quality studies and necessary planning activities for attainment under the new 8 hour average ozone NAAQS, and ( 2) develop a comprehensive emission reduction plan that will guide the region's actions to attain the 8 hour NAAQS. Furthermore, much of the technical and educational air quality activities conducted by AACOG are directed, reviewed, and approved by the AIR Committee. The Air Improvement Resources Committee is composed of five subcommittees as described below:

AIR Executive Committee The AIR Executive Committee is comprised of members representing the major government organizations within the San Antonio Metropolitan Statistical Area defined according to data from the 1999 U. S. Census. 1 The following municipal and county 1 At the time the Early Action Compact was signed, the MSA consisted of four counties: Bexar, Comal, Guadalupe, and Wilson. The bylaws of the AIR Committee state that " membership shall be extended to similar local governments brought into the San Antonio Metropolitan Statistical Area through US Census redesignations of the SA/ MSA boundary." As recently as December 2003, EPA Region 6 Administrator Richard Greene affirmed that only this four county region is recommended as the nonattainment area for the San Antonio region. Richard Greene's letter to Texas Governor Rick Perry, dated December 3, 2003, available online as: < http:// www. epa. gov/ air/ oaqps/ glo/ designations/ documents/ 03Recommendations/ 6/ s/ Texas_ R. pd f>. J 5 governments appoint one representative to serve on the AIR Executive Committee. The county government representative is an elected official serving as judge or commissioner. The municipal government representative is an elected official serving as mayor or city councilperson.

Bexar County

Comal County

City of Floresville

Guadalupe County

City of New Braunfels

City of San Antonio

City of Seguin

Wilson County In addition, the following entities appoint one representative to serve on the AIR Executive Committee:

Alamo Area Council of Governments Board of Directors

Greater Bexar County Council of Cities

San Antonio / Bexar County Metropolitan Planning Organization During its five year history, membership of the AIR Executive Committee has varied. Table J 1 provides a list of the AIR Executive members as of March 2004.

Table J 1. Executive ( voting) Members of AIR Committee. Agency Representative Bexar County Nelson Wolff, Bexar County Judge City of San Antonio Ed Garza, San Antonio Mayor / Chip Haas, City of San Antonio Councilman Comal County Jay Millikin, Comal County Commissioner City of New Braunfels Adam Cork, New Braunfels Mayor Guadalupe County Donald Schraub, Guadalupe County Judge City of Seguin Ernest Hernandez, City of Seguin Councilman Wilson County Marvin Quinney, Wilson County Judge City of Floresville Raymond Ramirez, Floresville Mayor Alamo Area Council of Governments Board of Directors Patrick Heath, AACOG Chairman Greater Bexar County Council of Cities Marcy Meffert, Leon Valley Mayor Bexar County San Antonio Metropolitan Planning Organization Julian Castro, City of San Antonio Councilman J 6 AIR Advisory Committee The AIR Advisory Committee acts as liaison between the AIR Executive Committee and the greater citizen sectors, both public and private. The membership of the AIR Advisory Committee includes the AIR Executive Committee membership. AIR Advisory Committee membership invitations are extended among the following groups and individuals, and others as determined by the Executive Committee, with all membership nominations made by members of the AIR Executive Committee and final approval for membership by vote of the AIR Executive Committee:

Business representatives

Environmental groups

Education agencies

Transportation organizers

Utilities

Industry representatives

Chambers of Commerce

Health organizations

Neighborhood organizations

Other elected officials

Minority organizations AIR Technical Committee The AIR Technical Committee is composed of technical staff representing local governments knowledgeable of air quality issues. The committee provides recommendations and technical assistance on air quality technical issues to the AIR Executive Committee for planning meetings held by the AIR Executive Committee. The following local planning agencies are represented on the Technical Committee.

AACOG

Bexar County

City Public Service ( Utility provider)

Comal County

City of Floresville

Guadalupe County

Metropolitan Health District

Metropolitan Planning Organization

City of New Braunfels

City of San Antonio

City of Seguin

Texas Commission on Environmental Quality ( ex officio)

Texas Department of Transportation ( TxDOT) District Office

United States Environmental Protection Agency ( ex officio)

Via Metropolitan Transit

Wilson County AIR Public Education Committee The AIR Public Education Committee is charged with disseminating information about the ozone challenge through news media and public events. Its mission is to educate the public about local air quality problems and issues. The Public Education Committee makes recommendations to the AIR Executive / Advisory Committee on ways to increase media coverage of air quality issues and provide air quality information to the J 7 general public. Membership of the AIR Public Education Committee includes representatives of local governments, utilities, and transportation organizations.

Off Road Equipment Subcommittee The AIR Off road Equipment Subcommittee works with local industry to promote voluntary implementation of ozone control strategies and studies the impact of legislation and other legal issues on the off road community. The Off Road Subcommittee membership includes owners/ operators of off road equipment in the public and private sectors.

Alamo Area Clean Cities Coalition Although the Alamo Area Clean Cities Coalition is not a subcommittee of the AIR Committee, the coalition encourages local governments and organizations to form public/ private partnerships to develop markets for alternative fuel vehicles ( AFVs). Clean Cities is a voluntary federal program funded by the U. S. Department of Energy to accelerate and expand the use of alternative fuels in communities throughout the country and to develop the necessary infrastructure for their operation.

Since 1996, the AACOG has supported the Alamo Area Clean Cities Coalition by hosting meetings, organizing awareness events, and developing project subcommittees that are chaired by members of the local community. As a regional planning organization, the coalition works to improve the quality of life in South central Texas including the 12 county area surrounding the City of San Antonio.

Public Participation Each meeting of each of the subcommittees of the Air Improvement Resources Committee system is open to the public. Although the AIR Technical Committee is a technical working group and is not a forum for policy development and action, the agendas of the regular meetings of this committee have always included a " Citizens to be Heard" item. In addition to a " Citizens to be Heard" item, the bylaws of the AIR Committee system allow citizens to address every action item on the AIR Executive/ Advisory Committee agendas, guaranteeing the right of the citizens to voice their opinion prior to any vote by the policy development and action committee.

Management / Communication Procedures Many of the technical decisions required by the modeling/ analysis protocol   such as episode selection, choice of photochemical models, and others   were first discussed and evaluated by representatives of the Texas Near Non attainment Areas ( NNAs), the Texas Commission on Environmental Quality, the Environmental Protection Agency, and other technical advisors during regularly scheduled meetings of the Texas NNA Working Group. A list of participants and stakeholders involved in the process is provided in part 2 of this appendix.

For instances where technical decisions affecting the San Antonio EAC Region ( SAER) were first evaluated and approved by the NNA Working Group, approval was subsequently sought at the local level. Technical decisions reviewed/ approved at the local level included such issues as episode selection and performance of the photochemical model. A typical process involving local participation would start with review and approval by the Texas NNA Working Group ( including input from TCEQ and EPA) followed by review and approval by the AIR Technical Committee. Upon approval by the Technical Committee, the group would provide recommendations to the AIR J 8 Executive/ Advisory Committee. Final decisions were made by vote of the Executive members during public meetings of the AIR Executive/ Advisory Committee. Whenever the protocol decisions involved matters of policy, the AIR Executive Committee made recommendations for action to the local governments represented by the AIR Executive Committee membership. Figure J 1 provides a flowchart of the communication process at the local level. J 9 Figure J 1. Flowchart of Communication Process of the Air Improvement Resources ( AIR) Committees.

AIR Executive /

Advisory Committee ( Public Meetings)

Recommendations to AIR Executive/ Advisory Committee Recommendations regarding actions and policies AIR Technical Committee Other Agencies Alamo Area Clean Cities Coalition Off Road Equipment Subcommittee AIR Public Education Committee Decision by vote of AIR Executive Committee Local Governments J 10 For decisions such as modeling of potential clean air strategies and selection of clean air strategies for adoption in the SIP, evaluation and approval were primarily local issues. Input regarding potential clean air strategies was sought from as many local stakeholders as possible including members of the AIR Technical Committee, the Alamo Area Clean Cities Coalition, and the Off road Equipment Subcommittee. Additionally, public input was encouraged through a series of meetings conducted by AACOG that addressed such topics as the Clean Air Plan, regional air quality, and clean air strategies as shown in table J 2.

AACOG staff provided news briefs to the media regarding public meetings to encourage participation as shown in exhibit A. The public meetings were held at various locations and in all four SAER counties to provide access to as many regional citizens as possible. In addition to citizen's comments made during public meetings, AACOG encouraged feedback by accepting public comments via mail, fax, and email. Public comments were compiled and provided to the AIR Executive Committee ( voting) members on a regular basis. J 11 Table J 2. Public Meetings Conducted in the SAER Counties.

Date Location Topic( s) of Discussion Purpose( s)

August 20, 2002 AACOG Boardroom 8626 Tesoro Drive Suite 100 San Antonio, TX 78217 Bexar County Regional Air Quality Clean Air Plan Non attainment designations Vehicle emissions testing To educate the public on the current air quality situation and the structure, purpose, and function of the Clean Air Plan.

To answer questions and gather comments regarding the Clean Air Plan, potential designation of " non attainment" by the EPA,

and vehicle emissions testing programs.

January 22, 2003 AACOG Boardroom 8700 Tesoro Drive Suite 100 San Antonio, TX 78217 Bexar County Early Action Compact and Clean Air Plan Pollution control strategies To educate the public on the structure,

purpose, and function of the Early Action Compact.

To answer questions and gather comments regarding the Early Action Compact, the Clean Air Plan, and air pollution control strategies to be considered.

February 22,

2003 AACOG Boardroom 8700 Tesoro Drive Suite 100 San Antonio, TX Bexar County Regional air quality Air pollution strategies under consideration Control strategy evaluation Early Action Compact and Clean Air Plan To update the public on our air quality situation and the process of evaluating potential air pollution control strategies for our Clean Air Plan.

To answer questions and gather comments regarding the Early Action Compact, the Clean Air Plan, and air pollution control strategies to be considered. J 12 March 19, 2003 Landa Haus 360 Aquatic Circle New Braunfels, TX 78130 Comal County Regional air quality Air pollution strategies under consideration Control strategy evaluation Early Action Compact and Clean Air Plan To update the public on our air quality situation and the process of evaluating potential air pollution control strategies for our Clean Air Plan.

To answer questions and gather comments regarding the Early Action Compact, the Clean Air Plan, and air pollution control strategies to be considered.

April 12, 2003 Seguin City Council Chambers 210 E. Gonzales Seguin, TX Guadalupe County Regional air quality Air pollution strategies under consideration Control strategy evaluation Early Action Compact and Clean Air Plan To update the public on our air quality situation and the process of evaluating potential air pollution control strategies for our Clean Air Plan.

To answer questions and gather comments regarding the Early Action Compact, the Clean Air Plan, and air pollution control strategies to be considered.

May 20, 2003 Criminal Justice Center 800 10th Street Floresville, TX Wilson County Regional air quality Air pollution strategies under consideration Control strategy evaluation Early Action Compact and Clean Air Plan To update the public on our air quality situation and the process of evaluating potential air pollution control strategies for our Clean Air Plan.

To gather comments regarding the Early Action Compact, the Clean Air Plan, and air pollution control strategies to be considered.

June 14, 2003 AACOG Boardroom 8700 Tesoro Drive Suite 100 San Antonio, TX 78217 Bexar County Regional air quality Control strategy evaluation To answer questions and update the public on our air quality situation and the process of evaluating potential air pollution control strategies for our Clean Air Plan. J 13 July 16, 2003 AACOG Boardroom 8700 Tesoro Drive Suite 100 San Antonio, TX 78217 Bexar County Regional air quality Control strategy evaluation To answer questions and update the public on our air quality situation and the process of evaluating potential air pollution control strategies for our Clean Air Plan.

November 5,

2003 AACOG Boardroom 8700 Tesoro Drive Suite 100 San Antonio, TX 78217 Bexar County Clean air strategies under consideration To provide information on the Clean Air Strategies being considered as a part of the region's Clean Air Plan.

To answer questions posed at previous Clean Air Plan workshops.

November 18,

2003 AACOG Boardroom 8700 Tesoro Drive Suite 100 San Antonio, TX 78217 Bexar County Air quality Clean Air Plan Clean air strategies To receive public comments on air quality, the Clean Air Plan, and Clean Air Strategies.

February 3, 2004 AACOG Boardroom 8700 Tesoro Drive Suite 100 San Antonio, TX 78217 Bexar County Draft Revision to the State Implementation Plan Clean air strategies under consideration To provide information on the Clean Air Strategies being considered as a part of the region's revision to the State Implementation Plan for air quality, and to gather public comment on those strategies. J 14 Choice of Air Quality Simulation Model and how it Meets Requirements in 40CFR51, Appendix W for using " Alternative" Models The September 1999 episode was modeled by ENVIRON International Corporation using the Comprehensive Air Quality Model with Extensions ( CAMx). In 2003, the federal guidance listing alternative models ( appendix B of 40 CFR Part 51, appendix W) was removed from appendix W ( Federal Register, 2003) and placed on EPA's Support Center for Regulatory Air Models ( SCRAM) web site. This web site lists CAMx as an alternative dispersion model ( EPA web page, no date).

Rationale for Choice of Air Quality and Emissions Model and Choice of Method for Generating Meteorological Inputs According to EPA's Summary Descriptions of Alternative Air Quality Models ( EPA web page, no date), " CAMx is appropriate for simulating hourly ozone, CO, and PM concentrations from the urban scale to regional scale." Furthermore, the Texas Commission on Environmental Quality supports the use of CAMx for regional scale modeling. The Attainment Demonstration for the Dallas/ Fort Worth Ozone Nonattainment Area ( TNRCC, 1999) states that models recommended by the EPA in past years had been replaced with updated counterparts such as CAMx that demonstrate " improved model chemistry, better treatment of vertical diffusion, and more realistic treatment of plumes." Because of these and other advantages, the TCEQ recommends the use of CAMx for ozone attainment demonstration modeling in Texas.

Emissions inputs to the photochemical model were developed by a variety of agencies. State and regional emissions for the base year ( 1999) and projection year ( 2007) were provided to AACOG from the Commission; therefore the state and regional EI data have undergone review and approval at the state level. For some categories of inputs, such as regional 2007 EI, the data were also federally approved. Local area and off road sources were developed by AACOG staff using EPA recommended / alternative methodologies or using EPA software models ( e. g., NONROAD). Local biogenic and point source data were provided by the Commission. With few exceptions, the Commission provided point emissions were used as model input. Examples where the Commission's data were not used included data developed from measurements recorded at or studies conducted for specific emission point sources ( e. g. a wastewater treatment plant and power plants) and provided to staff by representatives of those point sources. Appendices D and F provide additional information regarding methodologies/ models used to develop the modeling emission inventories.

The Fifth Generation Pennsylvania State University/ National Center for Atmospheric Research ( PSU/ NCAR) Mesoscale Model ( MM5) was utilized by ENVIRON to develop hourly, three dimensional meteorological input fields for CAMx. The original 1999 episode was developed using MM5v3.4 ( version 3, release 4). During the model refinement process, modelers were able to take advantage of the expanded capabilities of the recently released MM5v3.5. The fifth generation Penn State/ NCAR Mesoscale Model is the primary tool for providing meteorological input for EPA's Models 3/ Community Multiscale Air Quality ( CMAQ) modeling system. EPA recognizes that MM5 is widely used for providing meteorological characterizations throughout the air quality modeling community ( EPA web page, no date). Development of the meteorological inputs is explained in more detail in appendix B. J 15 Identification of Specific Deliverables and Schedule for Delivery to the Appropriate U. S. EPA Regional Office The Early Action Compact for the San Antonio region lists milestones that must be completed in accordance with a specified timeline. Most milestones include products for delivery to the TCEQ and U. S. EPA Region 6 Office. The sections of the milestone list that contain deliverables are reproduced in table J 3 below. Table J 3 also references the sections of the EAC where the milestones are described.

Table J 3. Schedule of Deliverables to U. S. EPA Region 6.

Milestone Delivery Date Reference in the Early Action Compact Emissions Inventory Milestones Development of a 1999 or later episode emissions inventory according to requirements in Chapter IV, b) March 31, 2004 Chapter IV, b)

Incorporate MOBILE6 data with Link Based Travel Demand Model data in urban areas March 31, 2004 Chapter IV, b)

Further emission inventory episode development based on local Conceptual Model update. Other episode inventories, if required, made in concert with EPA, TCEQ, and local entities. April 30, 2003 and April 30, 2005 Chapter IV, b)

NONROAD model data adjusted for local equipment populations and usage rates; Area source data is based when possible on local survey data. March 31, 2004 Chapter IV, b), c)

Modeling Milestones Develop SIP quality modeling episodes that perform within the EPA's accepted margin of accuracy, including a base case and future case on or before December 31, 2007. Documented & reviewed by TCEQ & EPA. Quantifiable emission reduction measures in the future case to produce one or more control cases. Control strategies determined against control case model. September 30, 2003 Chapter IV, c)

Develop other episodes as necessary to fully represent the variety of situations that typically contribute to local ozone production Updates delivered by April 30, 2003 and April 30, 2005 Chapter IV, c)

Control Strategy Development Milestones Identify additional local controls, as necessary, to demonstrate 2007attainment of the 8 hour standard. Controls implemented by Dec. 31, 2005, with full local stakeholder participation. Future case analysis, control cases and control case showing achievement of the 8 hour ozone standard on or before Dec. 31, 2007 will be delivered as a report by March 31, 2004 from AACOG Chapter IV, d)

All control measures will be incorporated by the state into the State Implementation Plan. March 31, 2004 Chapter IV, d)

Maintenance for Growth Milestones Component to address emissions growth at least 5 years beyond December 31, 2007, ensuring that the area will remain in attainment of the 8 hour standard during that period. March 31, 2004. Chapter IV, e) J 16 Milestone Maintenance for Growth Milestones ( continued) Delivery Date Reference in the Early Action Compact If the review of growth demonstrates that adopted control measures are inadequate to address growth in emissions, additional measures will be added to the plan After December 31, 2004. See conclusion to Appendix L for details. Chapter IV, e)

Data Access Input files for and output files generated from the photochemical model have been archived by the Alamo Area Council of Governments, the Texas Commission on Environmental Quality, and the University of Texas at Austin. Other data access issues are described in the table below ( J 4).

Table J 4. Data Access Protocol. Computer on which files were generated and can be read Red Hat Linux 9.0, Pacific Group Fortran Compiler 1 gigabyte ( gb) of DDR Ram 4 200 gb IDE hard drives, 1 80 gb SCSI hard drive Software necessary to process model outputs EPS2, CAMx version 3.10b, camxpost, camxtract, avgcat, PAVE, Perl Contact person Steven Smeltzer, Environmental Manager, AACOG 210/ 362 5266 ssmeltzer@ aacog. com Means for downloading files Hard drive or off site ftp server Administrative procedures which need to be satisfied to access files Written request to:

Steven Smeltzer Environmental Manager Alamo Area Council of Governments 8700 Tesoro Drive, Suite 700 San Antonio, TX 78217 Other Protocol Topics The EPA lists other modeling/ analysis protocol steps in their draft guidance that were performed during development of the 1999 model, but are discussed in other areas of this attainment demonstration SIP. Table J 5 provides a list of these other protocol topics and the location of their descriptions in the SAER SIP and/ or SIP appendices. J 17 Table J 5. Modeling/ analysis Protocol Steps Described elsewhere in SIP Modeling/ Analysis Protocol Topic Location in SIP Scientific peer review of modeling procedures and outputs Chapter 3 of Executive Summary   Section 3.3. Analyses included in the weight of evidence (" WOE") determination A " weight of evidence" study as defined by EPA's draft 8 hour guidance was not required or appropriate, given definition of WOE; however, similar " additional evidence" analyses are provided in Chapter 5 of the Executive Summary ( Section 5.5) and appendix K Database used to support air quality modeling and other types of analyses Chapter 3 of Executive Summary   Sections 3.4 and 3.5 and appendices B, C, D, E, and F Methods used to quality assure emissions inputs Chapter 3 of Executive Summary   Section 3.5.3 Domain size and spatial resolution to be used Chapter 3 of Executive Summary   Section 3.3 Criteria/ goals in selecting periods to model and process to be used in selecting episodes Chapter 3 of Executive Summary   Section 3.2 and appendix A Performance evaluation procedures and additional diagnostic tests planned Chapter 3 of Executive Summary   Sections 3.6 and 3.8 and appendices E and G Outcomes in the modeled attainment and screening tests as well as results of analyses to be used in a broader weight of evidence determination Chapters 3 and 5 of Executive Summary   3.9, 5.4, and 5.5 and appendices H and K J 18 References Federal Register ( April 15, 2003). 40 CFR Part 51Revision to the Guideline on Air Quality Models: Adoption of a Preferred Long Range Transport Model and Other Revisions; Final Rule. RIN 2060 AF01 Texas Natural Resource Conservation Commission ( February 24, 1999). Revisions to the State Implementation Plan for the Control of Ozone Air Pollution: Attainment Demonstration for the Dallas/ Fort Worth Ozone Nonattainment Area Rule Log No. 98046 SIP AI. Austin, TX.

US Environmental Protection Agency ( May 1999). Draft Guidance on the Use of Models and Other Analyses in Attainment Demonstrations for the 8 Hour Ozone NAQQS EPA 454/ R 99 004.

US Environmental Protection Agency ( no date). Atmospheric Modeling Models [ On line], Available: http:// www. epa. gov/ asmdnerl/ mm4. html US Environmental Protection Agency ( no date). Dispersion Models   Alternative Models [ On line], Available: http:// www. epa. gov/ scram001/ tt22. htm# camx.

US Environmental Protection Agency ( no date). Summary Descriptions of Alternative Air Quality Models [ On line], Available: http:// www. epa. gov/ scram001/ models/ other/ altmodel. pdf Exhibit A News Briefs for Public Meetings J 19 News Brief Clean Air Plan Workshop to Discuss Draft State Implementation Plan, Clean Air Strategies What: Clean Air Plan Workshop When: Tuesday, February 3, 2004 6: 00 p. m.   8: 00 p. m.

Where: Alamo Area Council of Governments Board Room 8700 Tesoro Drive, Suite 100, San Antonio, TX 78217 Why: To provide information on the Clean Air Strategies being considered as a part of the region's revision to the State Implementation Plan for air quality, and to gather public comment on those strategies.

Who: Open to the Public Cost: FREE Contact: Dorothy Birch ( 210) 362 5213 dbirch@ aacog. com More Info: To view the draft State Implementation Plan, visit www. aacog. com/ sip .

To learn about air quality and ozone pollution, visit www. aacog. com/ air. Contact: Dorothy Birch Natural Resources/ Transportation Specialist Alamo Area Council of Governments 8700 Tesoro Drive, Suite 700 San Antonio, TX 78217 dbirch@ aacog. com Phone ( 210) 362 5213 Fax ( 210) 225 5937 J 20 PART 2: MODELING PROTOCOL PREPARED BY ENVIRON INTERNATIONAL CORPORATION


[Federal Register: June 26, 2008 (Volume 73, Number 124)]
[Notices]
[Page 36331-36332]
[DOCID:fr26jn08-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0173]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Appeals of Science-
Based Decisions Above the Division Level at the Center for Veterinary
Medicine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
28, 2008.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-0566. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Appeals of Science-Based Decisions Above the Division Level at the
Center for Veterinary Medicine (OMB Control Number 0910-0566)--
Extension

    CVM's (Center for Veterinary Medicine) ``Guidance for Industry
79--Dispute Resolution Procedures for Science-Based Decisions
on Products Regulated by the Center for Veterinary Medicine'' describes
the process by which CVM formally resolves disputes relating to
scientific controversies. A scientific controversy involves issues
concerning a specific product regulated by CVM related to matters of
technical expertise and requires specialized education, training or
experience to be understood and resolved. Further, the guidance details
information on how the agency intends to interpret and apply provisions
of the existing regulations regarding internal agency review of
decisions. In addition, the guidance outlines the established
recommended procedures for persons who are applicants, including
sponsor applicants or manufacturers, for animal drugs or other products
regulated by CVM, that wish to submit a request for review of a
scientific dispute. When an applicant has a scientific disagreement and
a written decision by CVM, the applicant may submit a request for
review of that decision by following the established agency channels of
supervision for review.
    Respondents to this collection of information are applicants that
wish to submit a request for review of a scientific dispute.
    In the Federal Register of March 26, 2008 (73 FR 16021), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual frequency       Total annual        Hours per
                    21 CFR section                         respondents         per response          responses           response         Total hours
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10.75                                                                   2                     4                  8                 10                 80
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    This estimated annual reporting burden is based on CVM's experience
over the past 3 years in handling formal appeals for scientific
disputes. The number of respondents multiplied by the annual frequency
of response equals the total annual responses. The number of hours per
response is based on discussions with industry and may vary depending
on the complexity of the issue(s) involved and the duration of the
appeal process.

    Dated: June 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14515 Filed 6-25-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 127 (Tuesday, July 5, 2022)]
[Notices]
[Pages 39899-39901]
[FR Doc No: 2022-14165]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2022-055]

Denial of Motor Vehicle Defect Petition, DP21-004

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

ACTION: Denial of petition for a defect investigation.

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SUMMARY: This notice sets forth the reasons for the denial of a
petition submitted to NHTSA on September 14, 2021, requesting that the
agency investigate whether a defect related to motor vehicle safety
exists in van-type or box semi-trailers due to a lack of side underride
guards. On November 17, 2021, NHTSA opened Defect Petition DP21-004 to
evaluate petitioners' request. After a review of the petition and other
information, NHTSA has concluded that the issues presented by the
petitioners will be examined in work undertaken pursuant to
congressional direction under the Bipartisan Infrastructure Law.
Accordingly, the agency has denied the petition.

FOR FURTHER INFORMATION CONTACT: Mr. Nate Seymour, Medium and Heavy
Duty Vehicle Division, Office of Defects Investigation (ODI), NHTSA,
1200 New Jersey Ave. SE, Washington, DC 20590. Telephone:<PHONE_NUMBER>.
Email: [email protected].

SUPPLEMENTARY INFORMATION: In a letter dated September 14, 2021,
Marianne and Jerry Karth, Eric Hein, and Lois Durso (petitioners)
petitioned the National Highway Traffic Safety Administration (NHTSA)
to initiate a defect investigation into van-type or box semi-trailers
for a lack of side underride guards (SUGs). NHTSA's Office of

Defects Investigation (ODI) assessed the information provided by the
petitioners, as well as additional information that ODI gathered from
other relevant sources.
    The petitioners allege there is a known safety hazard and defect
where passenger vehicles or other vulnerable road users (pedestrians,
bicyclists, or motorcyclists) collide with van-type or box semi-
trailers resulting in death and significant injuries due to a lack of
SUGs. The petitioners state that at least 500 deaths and 5,000 serious
injuries occur annually due to side underride crashes. They also say
that a known solution is currently available.
    The subject vehicles are van-type or box semi-trailers operated in
the United States. The trailers range from twenty-eight feet (28') to
fifty-three feet (53') in length. They are typically eight feet (8') to
eight and a half feet (8.5') wide and up to thirteen and a half feet
(13.5') tall. Most have one fixed axle, or two axles mounted in tandem
on a sliding rail system at the rear. This allows for proper axle
weight distribution as per U.S. Bridge Laws, as well as increased
maneuverability when needed. Gross Vehicle Weight Ratings (GVWR) are
typically up to 68,000 pounds. All subject vehicles are currently
required to have rear underride protection as per Federal Motor Vehicle
Safety Standard (FMVSS) 224. The load floor height is approximately
four feet (4') above the ground. The space between the ground and floor
is often used for sliding tandems (axles), fuel tanks, air hoses, spare
tire carriers, and other optional fixtures. Additionally, many trailers
are now equipped with lightweight skirts to improve aerodynamics to
increase fuel efficiency.
    SUGs are intended to prevent a vehicle from underriding the trailer
in the event of a collision (an ``underride'' crash).\1\ The concept is
that a barrier of sufficient strength extends downward from the trailer
side to fill the space between the trailer floor and the ground.
---------------------------------------------------------------------------

    \1\ While petitioners allege that a lack of SUGs also poses a
safety hazard to vulnerable road users (e.g., pedestrians), that
results in death and injury, SUGs--the lack of which petitioners
assert constitutes a defect here--are devices that are specifically
intended to prevent a vehicle (not necessarily a vulnerable road
user) from underriding a trailer.
---------------------------------------------------------------------------

    ODI has received three (3) complaints, other than those from the
petitioners, related to trailer underride. All three of these
additional complaints involve vehicles older than Model Year 2006 and
were submitted by the same individual more than 11 years ago. Although
NHTSA's Early Warning Reporting (EWR) regulations do not have a
specific code for underride, searching the Death and Injury (D&I) EWR
data identified five (5) reports citing underride. The following table
summarizes the report year and the Model Year of the semi-trailer
involved.

------------------------------------------------------------------------
                                                           Model year of
                 Year reported to NHTSA                       trailer
------------------------------------------------------------------------
2021....................................................            2019
2021....................................................            2015
2013....................................................            2007
2006....................................................            1998
2018....................................................         Unknown
------------------------------------------------------------------------

    In early December 2021, ODI sent an Information Request letter to
eight (8) manufacturers asking for information related to side
underride. Letters were sent to the following trailer manufacturers:
Great Dane; Hyundai Translead; Kentucky Trailer; Stoughton; Strick
Trailers; Utility Trailer Manufacturing; Vanguard; and Wabash. ODI
received separate responses from each manufacturer by January 14, 2022,
and a supplemental response from Hyundai Translead on April 14, 2022.
    Each manufacturer was asked about its market share of the subject
vehicles. Most replied with a range, as the share varies from year to
year. ODI concluded that the eight manufacturers surveyed represent
nearly 100% of the subject vehicle population. Additionally, ODI asked
each manufacturer for its assessment of the current in-service subject
vehicle population. Based on the responses, the total vehicle
population is estimated to be 2.45 million trailers.
    The responses from the eight manufacturers identified over 20
events that may relate to underride from 2006 to 2022, including events
that involved death or injury. ODI was able to locate 19 of the events
within its databases. Title 49 of the Code of Federal Regulations (CFR)
Part 579 requires the trailer manufacturers to report whenever they
receive an allegation that a defect resulted in a death or injury. The
manufacturers responded that they are typically unaware of underride
events unless legal action is brought against them, or as in one case,
the trailer is brought in for repairs.
    ODI reviewed additional sources to better understand the
petitioners' claim that at least 500 deaths and 5,000 injuries occur
annually due to side underride crashes. A 2012 article by Matthew
Brumbelow titled ``Potential Benefits of Underride Guards in Large
Truck Side Crashes'' included a statistical analysis of Trucks Involved
in Fatal Accidents (TIFA).\2\ Between 2006 and 2008, 7,250 passenger
vehicle occupant deaths were recorded in two-vehicle crashes with large
trucks (tractor-trailers and single unit trucks). Using the 2006-2008
TIFA data, Brumbelow estimated that approximately 530 passenger vehicle
occupants died annually in two-vehicle crashes in which the passenger
vehicle struck the side of a large truck. Brumbelow noted that 20
percent of the side-impacted trucks were straight trucks, and those
remaining were tractor-trailers or tractors without trailers. However,
TIFA data files did not provide information on the impact location
(impact with tractor, between tractor and trailer, between front and
rear axles of the trailer, or behind the trailer rear wheels) and
whether the passenger vehicle underrode the truck. Brumbelow noted that
not all fatalities and injuries were due to vehicle underride and that
not all injuries in crashes with side underride could be mitigated by
side underride guards, because of the impact location, lack of
restraint use, high deceleration levels, and other factors. Using 2008-
2017 fatal crash data, NHTSA estimated that there were 212 light
passenger vehicle occupant fatalities annually in crashes into the
sides of tractor-trailers.
---------------------------------------------------------------------------

    \2\ Matthew L. Brumbelow, Potential benefits of underride guards
in large truck side crashes, 13 Traffic Inj. Prevention 592-99
(2012).
---------------------------------------------------------------------------

    In their petition, petitioners identify patents for side underride
guards held by two semi-trailer manufacturers that they state indicates
that the industry has already designed and tested a solution to the
alleged defect. The petitioners further state that another underride
guard, designed outside of the industry, has been successfully crash
tested and proven to stop a car from going under a semi-trailer in a
collision up to 40 mph. Multiple manufacturers have conducted testing
of various SUG devices, and some of the manufacturers queried by NHTSA
tested that guard on their trailers. According to the manufacturers, in
certain cases, either the trailers and/or the guard experienced
structural damage when the guard was fitted to a trailer and subjected
to the manufacturer's validation testing. The guard failed the
validation test, in other words. In one case, the testing was limited
to a floor endurance test as defined by the Truck Trailer Manufacturers
Association (TTMA) Recommended Practice 37-07 (RP 37-07). The
manufacturer reported that, while the guard-equipped trailer passed two
of the three tests, it failed the overload portion. This manufacturer

has had three customer inquiries about SUGs in the past ten years. The
manufacturer stated that at a customer's request it would install an
SUG. One other manufacturer noted that it offers a prototypical side-
impact guard as optional equipment where specifications are consistent
with a side-impact guard and it is determined the guard will not result
in an unsafe condition.
    Multiple manufacturers also reviewed the IIHS crash test of the
guard to which petitioners refer. Manufacturers expressed concerns over
various aspects of testing. Manufacturer responses indicated that the
trailer was not loaded in a typical manner, in that the load on the
trailer was concentrated in the back instead of being evenly
distributed across the entire floor (as it would be in a real-world
operation). For comparison, FMVSS 223 testing for rear underride
requires the test structure/trailer to be fixed so that it does not
move. One manufacturer conducted a separate crash test of the guard on
what it described as a properly loaded trailer, and noted the trailer
was displaced approximately three inches (3'') compared to over one
foot (12'') in the IIHS test scenario with the same make/model crash
vehicle and impact speed. The manufacturer described that in the IIHS
test, energy was dissipated when the trailer flexed and slid (reducing
the amount absorbed by the guard). The manufacturer had reservations
about performance of the guard, given that the weighting and loading
criteria in the IIHS test was not the same as that used for IIHS rear-
impact tests, and also expressed concern about exposure to real-world
conditions, including with regard to damage to the trailer and
attendant safety risks. One manufacturer also noted that the IIHS test
involved only a perpendicular impact at the center of the SUG. For
comparison, FMVSS 223/224 requires testing along multiple locations of
the rear guard. Crash data also shows a significant number of real-
world events involve collisions at acute and obtuse angles, and no such
tests are known to have been conducted with this guard.
    The petitioners claim that since 2010, this guard has been
installed on a small number of semi-trailers that logged over one
million miles of use delivering loads without negative road clearance
issues, structural deficiencies or issues with loading or unloading at
docks. A manufacturer response indicated that this statement is based
on one trailer operating a dedicated route. This is typical mileage for
such an operation, as most trucks average 100,000 miles per year. A
dedicated route means the trailer sees the same loading and unloading
facilities and travels the same terrain. Furthermore, this manufacturer
response stated that this unit is part of a multi-trailer fleet, and
that the fleet has not added additional of these guards to the rest of
its trailers.
    More broadly, certain manufacturers noted that SUGs may be
compatible with some trailer and fleet operations, although there was
the suggestion that a ``one size fits all'' approach is not possible in
the U.S. commercial vehicle market, where vehicles are designed and
purchased for specific operations or for versatility necessitated by
the fleet's operation. Multiple manufacturers are working on SUG
designs, and several manufacturers have filed patents for their
designs, although trailer manufacturers pointed out challenges. One
manufacturer noted it had not, to date, identified a feasible design to
prevent underride while not compromising the structural or operational
capabilities of the trailer. Another manufacturer developing a
prototype observed that testing is scheduled, but cited potential
material shortages and shipping delays. Furthermore, it appears there
is a hesitancy on the part of at least some manufacturers in the
industry to develop SUGs without research from NHTSA on their
effectiveness and cost.
    NHTSA is authorized to issue an order requiring notification and
remedy of a defect if the agency's investigation shows a defect in the
design, construction, or performance of a motor vehicle that presents
an unreasonable risk to safety. 49 U.S.C. 30102(a)(9), 30118. Factors
the agency may consider when deciding whether to grant or deny a defect
petition ``include, among others, allocation of agency resources,
agency priorities and the likelihood of success in litigation which
might arise from the order.'' 49 CFR 552.8. The above discussion
illustrates that the complex issues that the petitioners present would
benefit from additional information and data. NHTSA does not prescribe
a specific remedy even where a safety defect is identified, but the
agency may set performance standards for equipment--and recognizing a
need for further research and evaluation of SUGs, Congress included in
section 23011 of the Bipartisan Infrastructure Law (BIL) (November 15,
2021) several provisions that relate to side underride issues.
    Among these is a requirement that the Secretary of Transportation
``complete additional research on side underride guards to better
understand the overall effectiveness of side underride guards'' and,
``if warranted, develop performance standards for side underride
guards.'' The Secretary is also required to publish findings of an
assessment of the ``feasibility, benefits, and costs of, and any
impacts on intermodal equipment, freight mobility (including port
operations), and freight capacity associated with, installing side
underride guards on newly manufactured trailers and semitrailers with a
gross vehicle weight rating of 10,000 pounds or more,'' and after
taking public comment, submit to Congress a report that includes, among
other things, ``a determination as to whether the Secretary intends to
develop performance requirements for side underride guards, including
any analysis that led to that determination.'' In addition, the
Secretary must establish an Advisory Committee on Underride Protection
``to provide advice and recommendations to the Secretary on safety
regulations to reduce underride crashes and fatalities relating to
underride crashes.''
    Based on the available information and agency experience, ODI
believes the issues raised by the petitioners are best addressed
through the congressionally-directed evaluation of SUGs under section
23011 of the BIL. As the issues presented by the petitioners are being
addressed pursuant to such direction, NHTSA has decided not to open a
defect investigation, and the petition is denied. The denial of this
petition does not foreclose the agency from taking further action if
warranted or making a future finding that a safety-related defect
exists based upon additional information the agency may receive.
    Authority: 49 U.S.C. 30162(d); delegations of authority at CFR 1.95
and 501.8.

Anne Collins,
Associate Administrator, Enforcement.
[FR Doc. 2022-14165 Filed 7-1-22; 8:45 am]
BILLING CODE P


[Federal Register Volume 76, Number 36 (Wednesday, February 23, 2011)]
[Notices]
[Pages 10026-10028]
[FR Doc No: 2011-3717]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0005; FRL-8861-9]

Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces receipt of applications to register new
uses for pesticide products containing currently registered active
ingredients, pursuant to the provisions of section 3(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. EPA is
publishing this notice of such applications, pursuant to section
3(c)(4) of FIFRA.

DATES: Comments must be received on or before March 25, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number specified within the registration application summaries in
Unit II., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number specified
for the pesticide of interest as shown in the registration application
summaries in Unit II. EPA's policy is that all comments received will
be included in the docket without change and may be made available on-
line at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which

means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person is listed at the end
of each registration application summary and may be contacted by
telephone or e-mail. The mailing address for each contact person listed
is: Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001 and Biopesticides and Pollution Prevention
Division (7511P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
If you are commenting in a docket that addresses multiple products,
please indicate to which registration number(s) your comment applies.
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA received applications as follows to register pesticide products
containing currently registered active ingredients pursuant to the
provisions of section 3(c) of FIFRA, and is publishing this notice of
such applications pursuant to section 3(c)(4) of FIFRA. Notice of
receipt of these applications does not imply a decision by the Agency
on the applications.
    1. Registration Number/File Symbol: 279-3124, 279-3125, 279-3126.
Docket Number: EPA-HQ-OPP-2010-0472. Company name and address: FMC
Corporation, 1735 Market St., Philadelphia, PA 19103. Active
ingredient: Zeta-Cypermethrin. Proposed Uses: Avocado, black sapote,
canistel, mamey sapote, mango, papaya, sapodilla, star apple. Contact:
Linda DeLuise, Registration Division,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    2. Registration Number/File Symbol: 707-GEN, 707-GRO. Docket
Number: EPA-HQ-OPP-2010-1037. Company name and address: Rohm and Hass
Company, 100 Independence Mall West, Philadelphia, PA 19106. Active
ingredient: 2-Methyl-1, 2-benzisothiazol-3 (2H)-one. Proposed Uses: For
use in ATD emulsion products, paints, building materials, adhesives and
sealants, ink, textiles, paper coating, functional chemicals, household
and I&I, oil process water and recovery system, metalworking fluids.
Contact: Abigail Downs, Antimicrobials Division,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    3. Registration Number/File Symbol: 1677-EGU. Docket Number: EPA-
HQ-OPP-2010-1035. Company name and address: ECOLAB Inc., 370 North
Wabasha St., St. Paul, MN 55102. Active ingredient: L-lactic acid
Proposed Use: Commercial water additive in fruit and vegetable
processing and wash. Contact: Jacqueline Campbell-McFarlane,
Antimicrobials Division,<PHONE_NUMBER><EMAIL_ADDRESS>    4. Registration Number/File Symbol: 5383-RUE. Docket Number: EPA-
HQ-OPP-2009-1000. Company name and

address: Troy Chemical, Inc., 8 Vreeland Rd., P.O. Box 955, Florham
Park, NJ 07932-4200. Active ingredient: Terbutryn. Proposed Uses:
Materials preservation of coatings, stuccos, roof coatings, joint
cements, and sealants. Contact: Jacqueline Campbell-McFarlane,
Antimicrobials Division,<PHONE_NUMBER><EMAIL_ADDRESS>    5. Registration Number/File Symbol: 5383-RUN. Docket Number: EPA-
HQ-OPP-2009-1000. Company name and address: Troy Chemical, Inc., 8
Vreeland Rd., P.O. Box 955, Florham Park, NJ 07932-4200. Active
ingredient: Terbutryn. Proposed Uses: Materials preservation of joint
cements, coatings, sealants, stuccos, and plastics. Contact: Jacqueline
Campbell-McFarlane, Antimicrobials Division,<PHONE_NUMBER><EMAIL_ADDRESS>    6. Registration Number/File Symbol: 6836-322. Docket Number: EPA-
HQ-OPP-2010-1034. Company name and address: Lonza Inc., 90 Borderline
Rd., Allendale, NJ 07401. Active ingredient: 1, 3-Bis (hydroxymethyl)-
5, 5-dimethylhydantoin and Hydroxymethyl-5, 5-dimethylhydantoin.
Proposed Use: Secondary oil recovery for hydantonins. Contact:
Jacqueline Campbell-McFarlane, Antimicrobials Division,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    7. Registration Number/File Symbol: 8033-20, 8033-96, and 8033-109.
Docket Number: EPA-HQ-OPP-2011-0007. Company name and address: Nippon
Soda Co., Ltd., c/o Nisso America Inc., 45 Broadway, Suite 2120, New
York, NY 10006. Active ingredient: Acetamiprid. Proposed Use: Food/feed
handling establishments. Contact: Jennifer Urbanski, Registration
Division,<PHONE_NUMBER><EMAIL_ADDRESS>    8. Registration Number/File Symbol: 11556-RLU, 11556-RLL. Docket
Number: EPA-HQ-OPP-2011-0013. Company name and address: Bayer
HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission,
Kansas 66201-0390. Active ingredient: Flumethrin. Proposed Uses: Dogs
and cats. Contact: BeWanda Alexander, Registration Division, (703) 305-
7460<EMAIL_ADDRESS>    9. Registration Number/File Symbol: 59639-107 and 59639-138. Docket
Number: EPA-HQ-OPP-2010-0968. Company name and address: Valent U.S.A.
Corp, 1600 Riviera Ave., Suite 200, Walnut Creek, CA 94596. Active
ingredient: Etoxazole. Proposed Use: Corn and popcorn. Contact: Autumn
Metzger, Registration Division,<PHONE_NUMBER><EMAIL_ADDRESS>    10. Registration Number/File Symbol: 65402-8. Docket Number: EPA-
HQ-OPP-2010-1030. Company name and address: FMC Corporation, Peroxygens
Division, 1735 Market St., Philadelphia, PA 19103, Submitted by: Keller
and Heckman, LLC, 1001 G St., NW., Washington, DC 20001. Active
ingredient: Hydrogen Peroxide at 23% and Ethaneperoxoic Acid at 15%.
Proposed Use: To treat sewage and wastewater effluent related to public
and private wastewater treatment plants. Contact: Karen M. Leavy,
Antimicrobials Division,<PHONE_NUMBER><EMAIL_ADDRESS>    11. Registration Number/File Symbol: 87358-R. Docket Number: EPA-
HQ-OPP-2010-1038. Company name and address: Quick-Med Technologies,
Inc., 160 West Camino Real, 238, Boca Raton, FL 33432. Active
ingredient: Hydrogen Peroxide. Proposed Use: Materials preservative
applied to textiles for commercial and industrial use only.  Contact:
Martha Terry, Antimicrobials Division,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: February 10, 2011.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2011-3717 Filed 2-22-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 18 (Thursday, January 27, 2011)]
[Notices]
[Pages 4919-4920]
[FR Doc No: 2011-1753]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0046]

Regulatory Site Visit Training Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for
Biologics Evaluation and Research (CBER) is announcing an invitation
for participation in its Regulatory Site Visit Training Program (RSVP).
This training program is intended to give CBER regulatory review,
compliance, and other relevant staff an opportunity to visit biologics
facilities. These visits are intended to allow CBER staff to directly
observe routine manufacturing practices and to give CBER staff a better
understanding of the biologics industry, including its challenges and
operations. The purpose of this document is to invite biologics
facilities to contact CBER for more information if they are interested
in participating in this program.

DATES: Submit either an electronic or written request for participation
in this program by February 28, 2011. The request should include a
description of your facility relative to products regulated by CBER.
Please specify the physical address(es) of the site(s) you are
offering.

ADDRESSES: If your biologics facility is interested in offering a site
visit, submit either an electronic request to http://www.regulations.gov or a written request to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. If you previously responded to earlier
requests to participate in this program and you continue to be
interested in participating, please renew your request through a
submission to the Division of Dockets Management.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Henderson, Division of
Manufacturers Assistance and Training, Center for Biologics Evaluation
and Research (HFM-49), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>, FAX: 301-827-
3079, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    CBER regulates certain biological products including blood and
blood products, vaccines, and cellular, tissue, and gene therapies.
CBER is committed to advancing the public health through innovative
activities that help ensure the safety, effectiveness, and availability
of biological products to patients. To support this primary goal, CBER
has initiated various training and development programs, including
programs to further enhance performance of its compliance staff,
regulatory review staff, and other relevant staff. CBER seeks to
continuously enhance and update review efficiency and quality, and the
quality of its regulatory efforts and interactions, by providing CBER
staff with a better understanding of the biologics industry and its
operations. Further, CBER seeks to enhance: (1) Its understanding of
current industry practices and regulatory impacts and needs and (2)
communication between CBER staff and industry. CBER initiated its RSVP
in 2005. Through these annual notices, CBER is requesting those firms
that have previously applied and are still interested in participating,
to reaffirm their interest. CBER is also requesting new interested
parties to apply.

II. RSVP

A. Regulatory Site Visits

    In this program, over a period of time to be agreed upon with the
facility, small groups of CBER staff may observe operations of
biologics establishments, including for example, blood and tissue
establishments. The visits may include the following: (1) Packaging
facilities, (2) quality control and pathology/toxicology laboratories,
and (3) regulatory affairs operations. These visits, or any part of the
program, are not intended as a mechanism to inspect, assess, judge, or
perform a regulatory function, but are meant to improve mutual
understanding and to provide an

avenue for open dialogue between the biologics industry and CBER.

B. Site Selection

    CBER will be responsible for all travel expenses associated with
the site visits. Therefore, selection of potential facilities will be
based on the coordination of CBER's priorities for staff training as
well as the limited available resources for this program. In addition
to logistical and other resource factors to consider, a key element of
site selection is a successful compliance record with FDA or another
Agency with which we have a memorandum of understanding. If a site
visit also involves a visit to a separate physical location of another
firm under contract to the applicant, the other firm also needs to
agree to participate in the program, as well as have a satisfactory
compliance history.

III. Requests for Participation

    Identify requests for participation with the docket number found in
the brackets in the heading of this document. Received requests are
available for public examination in the Division of Dockets Management
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1753 Filed 1-26-11; 8:45 am]
BILLING CODE 4160-01-P


Site Visit

Safety Kleen – Dolton, Illinois

May 16, 2006

On May 16, 2006, representatives of the EPA Hazardous Waste
Identification Division visited Safety Kleen’s Dolton facility to
discuss their recycling operations at that site. In attendance:

Charlotte Mooney	EPA

Amy Lile		EPA

Kathy Blanton		EPA

Bob Burke		Safety Kleen 	Dolton 	EH&S Manager

Alfred Aghapour	Safety Kleen	Chicago	Facility Manager

Gary Malinowski	Safety Kleen	Chicago	EH&S Manager

Jim Weisanen		Safety Kleen 	Senior Director East – Processing and
Distribution

Mike Fusco	Safety Kleen 	Director of Legislative Affairs, NE Region EH&S
Manager

Dave Sprinkle	Safety Kleen 	Executive Vice President of Operations

Lin Longshore	Safety Kleen	Senior Vice President of Engineering and EH&S

Derald Bogs	Safety Kleen	Dolton		Facility Manager

Tim Riehl	Safety Kleen	Senior Director West – Processing and
Distribution

Bill Schede	Safety Kleen	Dolton		Operations Manager

Those present at the site visit discussed the history of Safety Kleen
and of the Dolton facility in particular as well as the structure of
Safety Kleen’s recycling operations nationwide and their standard
recycling procedures. EPA also took a tour of the Dolton facility to see
the design of its operations for recycling the solvent collected at
Safety Kleen’s customers’ facilities. In discussions of EPA’s
proposed rulemaking on the definition of solid waste, Safety Kleen
representatives expressed a concern about the “same industry”
requirement in the proposed rule because that would leave commercial
operations specializing in recycling out of the exclusion. They also
expressed support for the proposed “broad option” and supported
requirements such as financial assurance, environmental safeguards,
tracking systems, and the legitimacy criteria.