2352 Federal Register / Vol. 69, No. 10 / Thursday, January 15, 2004 / Notices discussions, panelists will be preselected from stakeholder groups, including industry, government, academia, and public interest groups.

B. How Should I Prepare for the Workshop? The workshop will be a working meeting, with participants expected to provide thoughtful discussion and concrete suggestions on the topics identified above. EPA requests attendees to participate in all sessions to ensure productive collaboration and adequate representation of stakeholder perspectives. EPA also requests that participants review relevant background documents prior to the meeting. A tentative agenda and related documents will be made available at http:// www. epa. gov/ pesticides/ biopesticides. EPA supports the goals of green conferencing and strongly encourages participants at this meeting to recycle, reduce the use of paper products and bulk mailings, and use mass transit. The meeting location is within walking distance of the Crystal City Metro Stop on the Blue and Yellow Lines. More about green conferencing can be found at: http:// www. epa. gov/ oppt/ greenmeetings/.

III. How Can I Request to Participate in this Meeting? Preregister for this workshop by contacting Teresa Bullock at American Farmland Trust by email tbullock@ niu. edu, by telephone ( 815   753   9347) or by fax ( 815   753   9348). You must preregister on or before February 2, 2004 or you can register on site the day of the workshop.

List of Subjects Environmental protection, FIFRA, Plant Incorporated Pesticides, Experimental Use Permits, Biotechnology, Biopesticides.

Dated: January 8, 2004. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division. [ FR Doc. 04   893 Filed 1   14   04; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPPT   2003   0055; FRL   7340   8]

Questions and Answers for the New Chemicals Program; Notice of Availability AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: EPA is announcing the availability of, and opportunity to comment on, the `` Questions and Answers for the New Chemicals Program ( Q& A).'' The Q& A document is intended to explain and clarify the requirements of TSCA section 5 and selected EPA regulations implementing TSCA section 5, and to provide useful information to persons subject to these requirements. DATES: Comments, identified by docket ID number OPPT   2003   0055, must be received on or before March 15, 2004. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Director, Environmental Assistance Division ( 7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 554   1404; e mail address: TSCAHotline epa. gov. For technical information contact: Virginia Lee, Chemical Control Division ( 7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 564   0883; e mail address: lee. virginia@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

This action is directed to the public in general, and may be of particular interest to those persons who are involved in the manufacture or import of chemical substances subject to TSCA section 5. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPPT   2003   0055. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102   Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is ( 202) 566   1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is ( 202) 566   0280. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. The Q& A is available electronically at http:// www. epa. gov/ opptintr/ newchems/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA VerDate jul< 14> 2003 14: 34 Jan 14, 2004 Jkt 203001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 15JAN1. SGM 15JAN1 2353 Federal Register / Vol. 69, No. 10 / Thursday, January 15, 2004 / Notices intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. 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. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket/, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPPT   2003   0055. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to oppt. ncic@ epa. gov, Attention: Docket ID Number OPPT   2003   0055. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your email address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Document Control Office ( 7407M), Office of Pollution Prevention and Toxics ( OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. By hand delivery or courier. Deliver your comments to: OPPT Document Control Office ( DCO) in EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC, Attention: Docket ID Number OPPT   2003   0055. The DCO is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is ( 202) 564   8930.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, 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 CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any 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 and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

We invite you to provide your views on the various options we propose, new approaches we have not considered, the potential impacts of the various options ( including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of the final action. You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide specific examples to illustrate your concerns. 4. Offer alternative ways to improve the document. 5. Make sure to submit your comments by the deadline in this notice. 6. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

VerDate jul< 14> 2003 14: 34 Jan 14, 2004 Jkt 203001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 15JAN1. SGM 15JAN1 2354 Federal Register / Vol. 69, No. 10 / Thursday, January 15, 2004 / Notices II. What Action is the Agency Taking? EPA is announcing the availability of and soliciting comments on the `` Questions and Answers for the New Chemicals Program ( Q& A).'' It is not a substitute for applicable legal requirements, nor is it a regulation itself. Thus, it does not impose legally binding requirements on any party, including EPA or the regulated community. In addition to the Q& A being available electronically and in the EPA docket, it is also available upon request from the TSCA Hotline.

List of Subjects Environmental protection, Chemicals.

Dated: December 31, 2003. Charles M. Auer, Director, Office of Pollution Prevention and Toxics.

[ FR Doc. 04   891 Filed 1   14   04; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ FRL   7610   1]

Notice of Tentative Approval and Solicitation of Request for a Public Hearing for Public Water System Supervision Program Revision for the State of West Virginia AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of tentative approval and Solicitation of Requests for a Public Hearing.

SUMMARY: Notice is hereby given in accordance with the provision of section 1413 of the Safe Drinking Water Act as amended, and the rules governing National Primary Drinking Water Regulations Implementation that the State of West Virginia has revised its approved Public Water System Supervision Program. West Virginia has adopted a Radionuclides Rule to establish a new maximum contaminant level ( MCL) for uranium and revise monitoring requirements. EPA has determined that these revisions are no less stringent than the corresponding Federal regulations. Therefore, EPA has decided to tentatively approve these program revisions. All interested parties are invited to submit written comments on this determination and may request a public hearing. DATES: Comments or a request for a public hearing must be submitted by February 17, 2004. This determination shall become effective on February 17, 2004, if no timely and appropriate request for a hearing is received and the Regional Administrator does not elect to hold a hearing on his own motion, and if no comments are received which cause EPA to modify its tentative approval.

ADDRESSES: Comments or a request for a public hearing must be submitted to the U. S. Environmental Protection Agency Region III, 1650 Arch Street, Philadelphia, PA 19103   2029. Comments may also be submitted electronically to Jennie Saxe at saxe. jennie@ epa. gov. All documents relating to this determination are available for inspection between the hours of 8 a. m. and 4: 30 p. m., Monday through Friday, at the following offices:   Drinking Water Branch, Water Protection Division, U. S. Environmental Protection Agency Region III, 1650 Arch Street, Philadelphia, PA 19103   2029.   Environmental Engineering Division, West Virginia Department of Health and Human Resources, 815 Quarrier Street, Suite 418, Charleston, WV 25301   2616.

FOR FURTHER INFORMATION CONTACT: Jennie Saxe, Drinking Water Branch ( 3WP22) at the Philadelphia address given above; telephone ( 215) 814   5806 or fax ( 215) 814   2318.

SUPPLEMENTARY INFORMATION: All interested parties are invited to submit written comments on this determination and may request a public hearing. All comments will be considered, and, if necessary, EPA will issue a response. Frivolous or insubstantial requests for a hearing may be denied by the Regional Administrator. However, if a substantial request for a public hearing is made by [ insert date 30 days from date of publication], a public hearing will be held. A request for public hearing shall include the following: ( 1) The name, address, and telephone number of the individual, organization, or other entity requesting a hearing; ( 2) a brief statement of the requesting person's interest in the Regional Administrator's determination and of information that the requesting person intends to submit at such a hearing; and ( 3) the signature of the individual making the request; or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.

Dated: December 15, 2003. Thomas Voltaggio, Acting Regional Administrator, EPA, Region III. [ FR Doc. 04   888 Filed 1   14   04; 8: 45 am]

BILLING CODE 6560   50   P FARM CREDIT ADMINISTRATION Farm Credit Administration Board; Amendment to Sunshine Act Meeting AGENCY: Farm Credit Administration. SUMMARY: Pursuant to the Government in the Sunshine Act ( 5 U. S. C. 552b( e)( 3)), the Farm Credit Administration gave notice on January 6, 2004 ( 69 FR 659), of the regular meeting of the Farm Credit Administration Board ( Board) scheduled for January 8, 2004. This notice is to amend the agenda by adding an item to a closed session of that meeting.

FOR FURTHER INFORMATION CONTACT: Jeanette C. Brinkley, Secretary to the Farm Credit Administration Board, ( 703) 883   4009, TTY ( 703) 883   4056. ADDRESSES: Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102   5090.

SUPPLEMENTARY INFORMATION: Parts of this meeting of the Board were open to the public ( limited space available), and parts of this meeting were closed to the public. In order to increase the accessibility to Board meetings, persons requiring assistance should make arrangements in advance. The agenda for January 8, 2004, is amended by adding the following item to a closed session as follows:

Closed Session*

Reports   Examination issue.

* Session closed   exempt pursuant to 5 U. S. C. 552b( c)( 8). Dated: January 13, 2004. Jeanette C. Brinkley, Secretary, Farm Credit Administration Board. [ FR Doc. 04   1068 Filed 1   13   04; 3: 53 pm]

BILLING CODE 6705   01   P FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Agency Meeting Pursuant to the provisions of the `` Government in the Sunshine Act'' ( 5 U. S. C. 552b), notice is hereby given that the Federal Deposit Insurance Corporation's Board of Directors will meet in open session at 10 a. m. on Tuesday, January 20, 2004, to consider the following matter: Summary Agenda: No matters are scheduled Discussed Agenda: Memorandum and resolution re: Joint Notice of Proposed Rulemaking   Community Reinvestment Act Regulations.

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9/ 2004 Page 1 of 17 Response Of Propanil Task Force II To The Review Of The U. S. Environmental Protection Agency I. INTRODUCTION This document responds to the review by the U. S. Environmental Protection Agency (" EPA" or " Agency") of the final reports from the " Evaluation of the Potential Exposure of Workers to Propanil During Mixing/ Loading and Aerial Application to Rice Fields Using Simultaneous Dermal Dosimetry and Biological Monitoring Techniques" and the " Propanil Exposures and Risk Assessment Based on Data From an Aerial Application Study in Rice with Liquid Formulations".

The Propanil Task Force II ( the " Task Force") believes that the passive dosimetry data developed in the study reflects the typical occupational exposure to propanil. Further, the Task Force believes that these data are the most reliable and relevant evidence of such exposure and should be used by the Agency for propanil risk assessment purposes.

Regarding the limited bio monitoring information collected in the study, the Agency reviewer correctly noted that " the Propanil Task Force II ( PTF II) did not attempt to use the bio monitoring data to perform a quantitative assessment of mixers/ loaders and pilots exposures to propanil". The Task Force has determined that quantitative assessment of exposure is not possible based on the bio monitoring data from this study and discusses this issue below.

In addition, the Agency reviewer noted a number of issues related to the conduct of the study. Explanation and clarification of each of those issues is provided in this document.

II. A QUANTITATIVE RISK ASSESSMENT BASED ON THE URINE DATA FROM WORKERS IS NOT RELIABLE OR APPROPRIATE In " Evaluation of the Potential Exposure of Workers to Propanil During Mixing/ Loading and Aerial Application to Rice Fields Using Simultaneous Dermal Dosimetry and Biological Monitoring Techniques", the Task Force attempted to use the urine monitoring data to perform a semi quantitative evaluation of propanil exposure recognizing that there were flaws in such an assessment. In the " Propanil Exposures and Risk Assessment Based on Data From an Aerial Application Study in Rice with Liquid Formulations", the approach for the semi quantitative evaluation of exposure was reevaluated and it was concluded that any type of quantitative assessment of exposure using the urine screening results was inappropriate. The basis for this conclusion was:

1. The semi quantitative assessment was based on a cursory evaluation of propanil metabolites that may be convertible to 3,4 dichloroaniline ( 3,4 DCA) by acid hydrolysis of rat urine from a metabolism study. In the absence of human 9/ 2004 Page 2 of 17 pharmacokinetics data, it is inappropriate to use rat metabolism data combined with the human urine monitoring data to quantify human exposure to propanil. 2. Most of the workers had propanil exposure prior to or shortly after the study application day which, even with human pharmacokinetic data to predict excretion rates and/ or steady state of non study related propanil exposure, makes interpretation of the data difficult at best.

Each of these items is discussed below.

A. Propanil/ DCA Analysis of Urine Samples and Propanil Metabolism Analysis of urine samples for 3,4 DCA from mixer/ loaders and pilots was included in the " Evaluation of the Potential Exposure of Workers to Propanil During Mixing/ Loading and Aerial Application to Rice Fields Using Simultaneous Dermal Dosimetry and Biological Monitoring Techniques" to provide a screening tool for propanil exposure. A rat metabolism study ( MRID Nos. 41796401 and 41796402) using radiolabelled propanil showed that 3,4 DCA is a minor metabolite of propanil representing < 1% of the total radioactivity in the urine. From a toxicological standpoint however, DCA represents a significant residue of concern for propanil since both propanil and 3,4 DCA are known inducers of methemoglobinemia, the most sensitive endpoint of concern for propanil. On this basis, the Agency's Health Effects Division ( HED) Metabolism Assessment Review Committee ( MARC) concluded that the propanil residues to be regulated in plants and animals are propanil and any residues convertible to 3,4 DCA. There was no need for individual quantitation of propanil metabolites since the residue analytical method in plants and animals determines base releasable total DCA expressed as propanil equivalent residues.

Following a single oral dose of propanil, the urine results from rat oral metabolism study showed that there are two distinct metabolic pathways:  Omega oxidation of the propionate side chain to form dicarboxylic acids, followed by conjugation with glucuronide.  Side chain cleavage with aromatic ring hydroxylation at the 6 position with subsequent conjugation with sulfate.

The results from the rat metabolism study clearly demonstrated that 3,4 DCA was a minor, transient metabolite of propanil. Recognizing the likelihood that only low levels of free DCA would be present in the workers' urine, the method of El Marbouh et al. ( 2002) was used. This method involved acid hydrolysis of urine which was expected to hydrolize DCA metabolites to parent DCA. The method was developed to provide a urine screening test for occupational exposure to 3,4 DCA. The intent of the method was not to quantify exposure.

In the initial Task Force Study report, the semi qualitative assessment of propanil exposure assumed that acid hydrolysis of urine would convert specific propanil metabolites, including products of detoxification, to DCA and that the urine metabolite 9/ 2004 Page 3 of 17 profiles would be similar between rats and man. A cursory evaluation of the metabolites seen in rat urine from the rat metabolism study suggested that approximately 47% of the metabolites would most likely convert to DCA upon acid hydrolysis and this value was inappropriately applied to give a semi quantitative measure of propanil exposure.

The supplemental Task Force Study report recognized significant flaws in this approach. First, the absence of actual data regarding the conversion of propanil metabolites to total DCA makes application of any percentage factor unreliable. Second, the urine results from the rat metabolism study were based on total excretion over a 72 hour period and provided no pharmacokinetic evaluation of propanil excretion rate and half lives. These factors are important in determining anticipated metabolite levels at shorter and longer time periods such as used in the worker exposure study. Third, the rat metabolism study was conducted by the oral route, whereas, worker exposure in the study would be via the dermal and inhalation routes. Fourth, the rate of metabolism for many xenobiotics for rodent species have been shown to be different from other non rodent species including man. Even if a pharmacokinetics study in rats was available, the applicability of the half life and excretion rates in rats to humans could not be assumed to reflect those of humans. Thus, in the absence of human pharmacokinetics data, application of any conversion factors based on a rat metabolism study is inappropriate and speculative.

Thus, available data are not sufficient to quantify propanil exposure to humans based on urine levels of 3,4 DCA. Human pharmacokinetics data are necessary to provide a valid approach for quantification.

B. Non study Exposures to Propanil The protocol specified that urine would be collected from each study subject on the following schedule:  Day  1, starting with the first void approximately 24 hours prior to propanil application.  Day 0 ( application day) for time periods 0 12 hours and 12 24 hours.  Day 1 and Day 2 post application.

An important component of urine screening for 3,4 DCA was the specification that study participants avoid contact with any product containing propanil for at least 3 days prior to and 3 days following the study application day. Unfortunately, these circumstances could not be controlled in this worker exposure study. The worker exposure study was conducted with actual propanil applications to rice fields based on actual propanil orders to aerial applicator facilities from rice growers. During the spring/ summer of 2003, the rice growing regions in Louisiana, Texas and Arkansas experienced a great deal of rain and windy weather that resulted in the delay of many applications. The application would go forward only when rain was not expected and specific conditions regarding wind speed and wind direction were met. If these conditions occurred, the applicators moved quickly with the propanil application during the particular " window of opportunity." Because of the weather conditions, it was not possible to predict when a 9/ 2004 Page 4 of 17 commercial aerial application to rice would take place. Since the study was conducted during the peak propanil application period, it was anticipated that the exposure data collection would occur over approximately 6 weeks. Due to the adverse weather conditions, the exposure data collection period was approximately 12 weeks. As a result of uncertainties regarding the application day, a number of pre study urines were taken on subjects only to have the applications in which they were to be involved delayed. Further, applicators refused to not handle or apply propanil prior to or following the study applications since their livelihood was based on completing outstanding propanil orders within the weed growth periods specified by the label. Thus, a majority of the test subjects handled or applied propanil during the 3 days prior to and 3 days following the study application day.

The outcome was that most of the workers handled propanil on the days prior to the study application day, the days following the study application or in some cases both time periods. These exposures, coupled with the lack of human pharmacokinetic data, make it impossible to validly use the urine DCA concentrations seen in the worker study for assessing the risk of propanil to workers.

III. DESCRIPTION FOR PROPANIL USE PRACTICES APPLICATION TO RICE FIELDS The objective of the Task Force study was to measure potential exposure to mixer/ loaders and pilots from propanil that was mixed/ loaded and applied in a realistic and routine fashion. Achieving this objective allows exposure assessments to be performed in a way that determines an accurate risk to mixer/ loaders and pilots handling Propanil.

Information about Propanil use pattern on rice fields is significant to a reliable understanding of potential exposure issues to mixer/ loaders who handle the concentrated product and to understanding potential exposure to pilots who apply the diluted product. The following is a description of the use pattern of propanil on rice fields and information that should be considered and examined when considering exposure scenarios to both mixer/ loaders and pilots handling propanil.

A. Propanil Use Rates:

Propanil used for weed control in rice is sold in 30 35 gallon drums in the form of several products such as STAM* M 4, Arrosolo ® 3 3E, WHAM! EZ, DUET ® CA, and other products. Propanil is used to control weeds that have emerged and is always applied to drained rice fields. For this reason excessive rain can delay applications since draining of the rice fields becomes an overriding factor in scheduling application times. Propanil is most commonly applied at 3 to 4 lbs ai/ Acre when grasses are actively growing in the 3 4 leaf stage approximately 15 25 days after planting. Higher rates of propanil at 4 6 lbs ai/ Acre are sometimes used when grasses are in the 4 6 leaf stage about 20 30 days after planting or for emergency or " rescue" operations for older tillering grasses about 30 40 days from planting. 9/ 2004 Page 5 of 17 B. Methods of Handling Propanil During Mixing/ Loading of the Product:

The loading of propanil products into a spray tank of an airplane occurs in two stages. Propanil is removed from the product drum using a siphoning device commonly called a " STAM" pipe. This pipe has graduations on the outside and an adjustable stop around the pipe. This pipe is attached to a hose that goes through a pump and into a mix tank. The mixer/ loader adjusts the stop on the " STAM" pipe up or down until the gradation on the pipe indicates how many quarts or gallons will be removed from the drum of product. The pipe is then placed into the hole in the lid of the drum where the stop on the pipe allows the withdrawal of the desired volume from the drum. The predetermined amount of formulation is removed from the drum and pumped into a mix tank where water is added. The siphoning device is left in the drum until the drum is emptied. It is then removed from the drum and set aside until needed again. This is similar methodology to that represented by the data in PHED. Propanil is mixed with other products and water in the mix tank and the mixture is transferred to the airplane spray tank via a dry lock connector that attaches to the airplane tank from the mix tank. The entire mixing/ loading process is usually performed by the mixer/ loader while the pilot stays in the airplane. The entire mixing/ loading process takes approximately 5 10 minutes between applications.

C. Factors Affecting the Daily Mixing/ loading and Application Time of Propanil Products:

Propanil applications are made only when the grower places an order at the aerial application facility. The application facility responds to the order for application based on several factors:

1. If weather conditions have allowed floodwater to be drained off of the field, the application will proceed.

2. If the wind is below 10 mph the aerial applicator will proceed with the application.

3. If the wind direction is such that potential drift will not be in the direction of neighboring homes or non target crops, the application will proceed.

Propanil orders and wind factors are very real and practical constraints placed on the aerial applicator. In Louisiana for example the state monitors complaints from neighbors who may take exception to an application of propanil in which there was some drift onto neighboring homes or crops. The state will levy fines of up to several thousand dollars to aerial applicators when complaints from neighbors reach a designated level.

Wind factors come into play when planning for propanil applications and play a major role in how long a mixer/ loader loads the chemical and how long the pilot applies the product. The mixer/ loader and pilot generally begin applying propanil as soon as the sun comes up to avoid wind problems. Morning fog may delay the initiation of application 9/ 2004 Page 6 of 17 and may delay the application completely if the wind becomes excessive after the fog clears. The pilot will apply loads of propanil until the wind reaches the limit of 10 mph or until the wind shifts to an unfavorable direction. When that happens, the pilot flies back to the aerial applicator facility where the spray boom will be switched to a fertilizer rig and the pilot will apply fertilizer the remaining time during the day while the wind stays above 10 mph. Consequently, under realistic conditions, it is not unusual for pilots to only apply propanil and mixer/ loaders will only load propanil for an average of about 2 hours per day.

A pilot can treat about 40 acres per load. Each load will take about 15 minutes of flying time.

Mixer/ loaders load Propanil for about 5 10 minutes for each load and will continue to load the plane as it comes in between applications. Mixer/ loaders will load fertilizer when the planes rigs are switched and do not continue to handle Propanil during the remaining part of the day.

D. Factors Affecting the Conduct of the 2003 Propanil Mixer/ Loader and Aerial Applicator Exposure Study:

All of the factors outlined above came into play during the 2003 propanil mixer/ loader aerial applicator exposure study.

1. Early Application Season Was Chosen for the Worker Exposure Study:

Early season application of Propanil was chosen in order to meet the protocol requirement of finding mixer/ loaders and pilots who did not have previous exposure to Propanil in 2003.

The season for planting rice crops moves from south Texas to Louisiana, and Arkansas as follows:

a. Rice planting in south Texas begins around mid to late February. Application of Propanil begins in late March and early April.

b. Rice planting in Louisiana begins in mid March to early April. Applications of Propanil begins in mid April to early May.

c. Rice planting in Arkansas begins in mid April to the end of April. Propanil applications begin in early May to June.

The above sequence of Texas to Louisiana to Arkansas was followed when finding test volunteers for this study and for scheduling applications of Propanil. 9/ 2004 Page 7 of 17 2. H. E. R. A. C., Inc. Field Scientists Waited for Propanil Orders from Growers and for Wind Conditions to be Favorable Before Performing each Replicate of the Study.

On most occasions the procedures for finding test subjects, test sites as well as scheduling the Propanil treatments were as follows:

a. The aerial applicator facility was contacted and a meeting was set up with the owner of the aerial applicator facility. If the owner of the aerial application facility approved the use of his/ her facility for performing the study, the owner would then recommend pilots and mixer/ loaders for the study.

b. A meeting was held with the pilots and mixer/ loaders to acquire their consent to be involved in the study.

c. The H. E. R. A. C., Inc. field scientist would then wait and contact the owner or pilot volunteer to determine when an order for Propanil came in and when the product was likely to be sprayed. At this point the H. E. R. A. C, Inc. field scientist would show up each morning at about 5: 00 AM at the aerial applicator facility to be sure that all the test equipment was in place if the wind conditions were to be favorable to apply Propanil. This procedure is time consuming, however, it is the only way to be certain to be present when an application of propanil is to take place.

On some occasions, rain delayed the scheduled application of the product. In northeastern Arkansas for example, excessive rains resulted in the growers being about 2 3 weeks behind in their planting.

IV. EPA COMMENTS: The protocol states that " mixer/ loaders will wear new or freshly laundered long sleeved shirts, new or freshly laundered long pants, new or freshly laundered t shirt and brief, new chemical resistant gloves, new shoes, new socks, and protective eyewear as required by the label." However, mixer/ loaders in the study wore either a chemical resistant apron or a Tyvek coverall over the " outer" dosimeter ( cotton coverall) and also wore chemical resistant footwear. In calculating potential dermal exposures to mixer/ loaders, the study author does not factor in this additional personal protective equipment, which exceeds the requirements of the product labeling.

Triple Layers for Mixer/ Loaders: In the study protocol, where the use of a protection factor was presented as an approach to calculating exposure to the torso, arms, and legs, the study authors stated that mixer/ loaders would wear new or freshly laundered long sleeve shirt and long pants over a tee shirt and briefs. 9/ 2004 Page 8 of 17 EPA agreed that such attire would permit the calculation of a penetration factor for estimating risks to the torso, arms, and legs. However, in the actual study, all mixer/ loaders wore either a chemical resistant apron or a tyvek coverall as an additional layer over cotton coveralls. The study did not use the residues on the apron or Tyvek coveralls, but measured residues on the cotton coverall as the " outer dosimeter" and the tee shirt and briefs as an " inner dosimeter." However, the apron provided a chemical resistant barrier over the coverall in the torso section and presumably reduced penetration to the coverall itself to a significant degree. Since an apron would not provide similar exposure to the legs and arms, applying a penetration factor calculated on the torso exposures to the residues on the arms and legs would result in a calculated penetration factor that would be artificially low. Similarly, the Tyvek coverall reduced exposure to the cotton coverall to a significant degree. Therefore, any calculated penetration factor also would be artificially low. HED considered calculating a penetration factor using the Tyvek coverall as an outer dosimeter and the cotton coverall as an inner dosimeter. However, only four mixer/ loader replicates were performed with Tyvek coveralls, which would not provide a statistically significant number. In addition, nonwoven fabric, such as Tyvek, is known to allow significantly less penetration than a cotton coverall, therefore a calculated penetration factor would not be representative of the penetration through cotton coveralls. Due to many practical, considerations, including cost and heat stress concerns, EPA does not require routine use by mixer/ loaders or applicators of coveralls made from Tyvek or other nonwoven fabrics.

Dermal Exposures to Mixer/ Loaders and Pilots: HED used the propanil passive dosimetry data to calculate dermal exposures to the torso, arms, and legs for the pilot scenarios only. HED did not calculated dermal exposure to the torso, arms, and legs for the mixer/ Loader or mixer/ loader/ applicator scenarios, since an appropriate protection factor could not be calculated from data as presented in the study. HED calculated the dermal body exposure to pilots using the same method as the study author. First, a penetration factor was derived by dividing the amount of residue on the inner dosimeter ( tee shirt and briefs) by the residue on the torso section of the outer dosimeter. Then the outer dosimeter residues for arms, legs and torso were multiplied by the penetration factor. For the pilot study, dermal unit exposures averaged 1.05E 04 mg/ lb ai for the arms, 4.82E 05 mg/ lb ai for the legs, and 7.46E 05 mg/ lb ai for the torso. HED then calculated total dermal unit exposure for pilots by summing the dermal unit exposures to hands ( from hand washes), to face, head, and neck ( from head patches), and to the arms, legs and torso ( as described above). Total dermal unit exposure estimates averaged 1.27E 03 mg/ lb ai handled for pilots. The total dermal unit exposure to mixer/ loaders and to mixer/ loaders/ applicator were not calculated by HED, since an appropriate protection factor could not be calculated from the data as presented in the study for dermal exposure to the torso, arms, and legs for these two scenarios. 9/ 2004 Page 9 of 17 A. RESPONSE TO EPA COMMENTS ON CALCULATION OF MIXER/ LOADER PROPANIL EXPOSURE.

1. Clarification of Clothing Scenario Worn by Mixer/ Loaders:

EPA refers to an " outer coverall" as an " outer dosimeter" in the comments shown above. " However, in the actual study, all mixer/ loaders wore either a chemical resistant apron or a tyvek coverall as an additional layer over cotton coveralls. The study did not use the residues on the apron or Tyvek coveralls, but measured residues on the cotton coverall as the " outer dosimeter" and the tee shirt and briefs as an " inner dosimeter." However, the apron provided a chemical resistant barrier over the coverall in the torso section and presumably reduced penetration to the coverall itself to a significant degree" The " outer dosimeter" worn by mixer/ loaders and pilots was a 100% cotton long sleeve shirt and 100% cotton long pants. These garments are referred to on pages 17, 19, and 22 of the final report: " Evaluation of the Potential Exposure of Workers to propanil During Mixing/ Loading and Aerial Application to Rice Fields Using Simultaneous Dermal Dosimetry and Biological Monitoring Techniques".

2. Task Force Proposal to Recalculate the Exposure of Propanil to Mixer/ Loaders:

The EPA has indicated that the method of the calculation of a penetration factor for the arms and legs of the mixer/ loaders may not be appropriate using the inner dosimeter in the torso area of the mixer/ loader since wearing a chemical resistant apron over the torso area could lead to an artificially low penetration factor. The Task Force proposes an alternative method to calculate the potential dermal exposure to the mixer/ loaders wearing the chemical resistant apron.

The proposed method to recalculate the dermal exposure to propanil mixer/ loaders uses a penetration factor of 10%. Average penetration factors ranging from 2 27% percent have been observed in studies since 1981 ( References 1 4). Thus, a reasonable average penetration factor to use for subsequent calculations would be 10% for the upper and lower arms as well as the back of the legs of the mixer/ loader. This 10% penetration factor is a conservative estimate of penetration since the front top of the thighs down to the ankle of the mixer/ loader were covered by the chemical resistant apron worn by the mixer/ loader test subjects in this study. This covered area of the body would result 9/ 2004 Page 10 of 17 in much less than 10% penetration through the front thigh and calf areas of the legs.

The Task Force's proposed method of calculation of exposure to the mixer/ loaders in this study is as follows:

a. The residues of propanil on the legs and arms of the outer dosimeter long sleeved cotton shirt and long cotton pants are summed. The sum is then multiplied by 0.1 to achieve the residue amounts given a 10% penetration factor for the cotton garments.

b. The corrected residue on the arms and legs of the mixer/ loader are then added to the residues of propanil on the t shirt and brief as well as to the residues in the handwash. This sum is then added to the head, face and neck residues derived from the head patch data to provide a total dermal body exposure for the worker.

The following table presents the calculation of dermal exposure and total dose for the mixer/ loaders in this study ( corrected for dermal penetration of 20%). Only workers wearing chemicalresistant aprons are considered when using this alternative method of calculating exposure. The four workers wearing the Tyvek coverall were excluded from the data set since the Tyvek coverall would produce in theory an artificially low residue on the outer dosimeter shirt and pants, rendering the arms and leg data from the shirt and pants outer dosimeter useless. 9/ 2004 Page 11 of 17 Worker ID V1 V3 V5 V7 V9 V13 V15 V19 V23 V27 Application. Date 4/ 12/ 03 4/ 3/ 03 4/ 14/ 03 5/ 6/ 03 4/ 12/ 03 4/ 17/ 03 4/ 17/ 03 4/ 29/ 03 5/ 9/ 03 5/ 19/ 03 Propanil Residues ( µ g) Outer Arms 402.9 2761 7749 37464 1027 1774 225.8 5696 2587 496.2 Outer Legs 152.6 196.7 2552 2156 1014 452.8 33.57 3017 531.4 136.1 Sum 555.5 2957.7 10301 39620 2041 2226.8 259.4 8713 3118 632.3 10% Pen. Factor 55.6 295.8 1030 3962 204 223 25.9 871 312 63.2 Tee Shirt+ Brief 5.655 18.4 26.3 17.7 36.57 7.334 2.319 30.84 88.88 13.79 Handwash 88.2 504 40.7 73.8 52.7 7.74 3.05 118 215 7.01 Head Patch 130 31.9 1778 2920 2829 14.4 2.36 106 1879 269 T. Dermal 279.5 850 2875 6974 3122 253 33.6 1126 2495 353 20% Dermal Pen. 55.9 170 575 1395 624 50.6 6.72 225 499 70.6 Inhalation Exposure 7.7 0.6 12.9 14.5 10.7 0.715 1.43 2.87 5.35 8.12 T. Dose ( µ g) 63.6 171 588 1410 635 51.3 8.15 228 504 78.7 Kg BW 65.8 72.6 99.9 65.8 129.4 62.7 84 95.3 68.1 99.9 µ g/ Kg BW/ day 0.97 2.4 5.9 21.4 4.9 0.82 0.097 2.39 7.4 0.79 Kg ai Handled 602.7 489.8 394.5 292 602.7 231.3 231.3 133.3 88.9 760.1 µ g/ Kg ai/ day 0.11 0.35 1.5 4.8 1.1 0.22 0.035 1.7 5.7 0.1 T. Dermal 279.5 850 2875 6974 3122 253 33.6 1126 2495 353 Kg ai Handled 602.7 489.8 394.5 292 602.7 231.3 231.3 133.3 88.9 760.1 Total Dermal ( ug/ Kg ai Handled) 0.46 1.74 7.29 23.9 5.18 1.09 0.145 8.45 28.1 0.46 Lb ai Handled 1329 1080 870 644 1329 510 510 294 196 1676 Total Dermal ( ug/ lb ai Handled) 0.21 0.79 3.30 10.83 2.35 0.50 0.066 3.83 12.7 0.21 T. Inhalation 7.7 0.6 12.9 14.5 10.7 0.715 1.43 2.87 5.35 8.12 Kg ai Handled 602.7 489.8 394.5 292 602.7 231.3 231.3 133.3 88.9 760.1 Total Inhalation ( ug/ Kg ai Handled) 0.013 0.0012 0.033 0.050 0.018 0.003 0.006 0.022 0.060 0.011 Lb ai Handled 1329 1080 870 644 1329 510 510 294 196 1676 Total Inhalation ( ug/ lb ai Handled) 0.0058 0.00056 0.015 0.023 0.0081 0.0014 0.0028 0.0098 0.0273 0.0048 The results of the recalculated dermal exposure for the mixer/ loaders in this study show that the total dose ( dermal exposure corrected for dermal penetration of 20% and normalized for worker body weight in Kg) ranged from 0.097 to 21.4 µ g/ Kg BW/ day ( Geometric Mean = 2.1 µ g/ Kg BW/ day; std dev. = 6.4 µ g/ Kg BW/ day).

When total dermal and inhalation exposures are normalized against pounds handled the resultant Geometric Means are: 1.30 ug/ lb ai for dermal and 0.0065 ug/ lb ai for inhalation. Exposure and risk 9/ 2004 Page 12 of 17 for Mixer/ loaders was recalculated based on the proposed method using a default penetration factor rather than a calculated one and only those workers who did not wear Tyvek. The results are presented in the following table. MOEs are acceptable for mixer/ loaders who load for as many as 1200 acres a day.

Study Data All Workers Study Data Without Tyvek MOE Rate ( lb ia/ A) 1200 Acres 350 Acres 1200 Acres 350 Acres Mixer/ Loader 3 880 3000 660 2200 6 440 1500 330 1100 Applicator 3 3100 11000 3100 11000 6 1600 5600 1600 5600 V. EPA COMMENTS: The study states that most mixers/ loaders used a siphoning device to transfer the propanil from the drum into the mix tank and then used a dry lock system ( an engineering control) to pump the dilute mixture into the airplane spray tank. This would result in artificially low mixer/ loader exposures due to the use of the engineering control in part of the mix/ load process.

A. RESPONSE TO EPA COMMENTS: USE OF ENGINEERING CONTROLS PRODUCE ARTIFICALLY LOW EXPOSURES TO MIXER LOADERS:

1. Objective of Study:

One of the objectives of this study was to measure potential exposure to mixer/ loader and pilots from propanil that was mixed/ loaded and applied in a realistic and routine fashion.

2. Standard Routine Mixing/ Applying Procedures for Mixer/ loaders and Aerial Applicators Handling and Applying Propanil Products:

Propanil is first removed from the drum into a mix tank using a siphoning device commonly called a " STAM" pipe ( see III DESCRIPTION FOR PROPANIL USE PRACTICES   APPLICATION TO RICE FIELDS for discussion). This system is similar to those included in PHED for Scenario 6 ( ALL LIQUIDS, CLOSED MIXING and LOADING ( MLOD)). The siphon device runs on a pump that transfers the propanil from the drum into a mix tank where the propanil is mixed with water. The propanil 9/ 2004 Page 13 of 17 water mixture is then pumped into the airplane spray tank via a closed system. This closed system consists of a dry lock coupling from the mix tank to the spray tank of the airplane. This mixing/ loading procedure is a routine operation and would not produce artificially low exposures.

VI. EPA COMMENTS: The protocol states " all workers will perform their work tasks for a typical amount of time that represents an entire workday. One replicate will be an entire workday for each test subject  the air sampling pump will operate for the entire monitoring replicate ( estimated to be 6 12 hours)." However, the average duration of actual handling for each replicate in the study was only 2.2 hours for mixer/ loaders and only 1.7 hours for pilots.

Reduced Likelihood of Penetration of Coverall: Penetration of a chemical through a matrix is dependent on three factors:

1. Composition of the matrix 2. Concentration of the residue on the matrix surface; and 3. Time of residue contact with the matrix surface.

This study used application rates lower than the maximum 6 pounds active ingredient listed in the protocol and on the product labeling ( STAM M4), with and average application rate in the study less than 3 pounds active ingredient per acre. In addition, this study involved much lower handling times than were listed in the protocol. The average actual handling time for mixer/ loaders was only 2.2 hours and for pilots were only 1.7 hours and the average dermal monitoring time was less than 4.5 hours for both handling tasks. The application rate factor would be expected to result in less residue being deposited on the outer dosimeter and the handling time factor would be expected to result in less time for the residue to penetrate the outer dosimeter 1. RESPONSE TO EPA COMMENTS:

A. Timing and Length of Aerial Applications of Propanil:

Propanil aerial applications generally take place in the early morning or may be applied in late evening when the wind is less than 10 mph. Due to the possibility of drift onto neighboring crops, liability issues play a major role in decisions to apply propanil even though the wind may be at a favorable velocity but at an unfavorable direction. In Louisiana for example, local authorities track the number of complaints that neighbors file concerning drift on to their property from aerial applications to adjacent farms. The aerial applicator is fined or penalized proportionally to the number of complaints that are logged by the authorities. 9/ 2004 Page 14 of 17 For the above reasons, propanil typically is only mixed/ loaded and applied during those periods of time when the wind conditions are favorable. The mixing/ loading times for workers in this study ranged from 0.37 hours to 5.3 hours ( median = 2.33 hours and average = 2.24 hours). There were only two workers who mixed/ loaded for less than one hour. These two replicates were cut short by wind factors or lack of propanil orders on the scheduled day of the test. Pilot application times ranged from 0.68 to 3.82 hours ( median = 1.59 hours and average = 1.67 hours). Only two pilots applied less than one hour. Again, these two replicates were abbreviated due to wind factors or lack of orders for propanil on the scheduled day of the test. The average work days for aerial applicators observed in this study of 2.2 hours for mixer/ loaders and 1.7 hours for pilots is realistic for the routine application of propanil during the rice season. The protocol also states that the study would monitor actual applications as they occur. A pilot may well spend 6+ hours treating rice during a normal day but most of that time will be spent applying fertilizer after weather conditions no longer allow propanil applications. The workers monitored in this study did work appropriate times and handled appropriate amounts of material. Recreating Scenarios 6 and 7 from the " PHED SURROGATE EXPOSURE GUIDE" ( August, 1998) allows one to look at the amounts of material handled for both the mixer/ loader and the pilot as well as the acres treated by the pilot. The following Tables present the statistics from the two scenarios for pounds handled.

Comparison of Hours worked in PHED vs. Hours worked in Propanil Study.

PHED Study All M/ L Workers Study w/ o Tyvek Hours Hours Hours Hours Hours Mixer/ Loader Applicator Mixer/ Loader Applicator Mixer/ Loader Geo Mean 2.1 1.1 1.9 1.5 1.6 Average 3.3 1.9 2.2 1.7 2.0 Median 4.2 0.73 2.3 1.6 2.0 75th Percentile 4.6 2.9 2.8 1.7 2.7 90th Percentile 4.8 4.6 3.4 2.1 3.4 Minimum 0.18 0.21 0.37 0.72 0.37 Maximum 4.8 9.4 5.3 3.8 3.4 9/ 2004 Page 15 of 17 Comparison of Pounds Handled in PHED vs. Pounds Handled in Propanil Study. PHED Study All M/ L Workers Study w/ o Tyvek Pounds Pounds Pounds Pounds Pounds Mixer/ Loader Applicator Mixer/ Loader Applicator Mixer/ Loader Geo Mean 222 44 629 544 626 Average 520 244 710 583 734 Median 127 19.5 644 579 610 75th Percentile 1022 248 837 757 1027 90th Percentile 1510 760 1229 798 1329 Minimum 3 2 364 195 196 Maximum 1569 1569 1328 870 1329 Comparison of Acres Treated in PHED vs. Acres Treated in Propanil Study. PHED Propanil Study Applicators Acres Treated Acres Treated Applicator Applicator Geo Mean 147 125 Average 286 151 Median 200 138 75th Percentile 366 200 90th Percentile 784 246 Minimum 10 32 Maximum 1061 334 As can be seen from the above data, the Geometric Mean, Average, Median and Minimum Pounds Handled for the propanil study all exceed those same values for the data in PHED. This is true for the original interpretation of the study data and for the interpretation that excludes those workers wearing Tyvek. Further, the hours worked is consistent with PHED and likewise supports that the propanil data from the Study are superior to PHED with its pounds handled. Therefore, the propanil study is not only appropriate based on the agronomic and climatological realities of propanil applications in rice but is, since it was conducted on the molecule of interest and is more robust than PHED, more realistic and appropriate for estimation of exposure to workers involved in propanil use in rice. 9/ 2004 Page 16 of 17 B. National Agricultural Aviation Association` s Survey 2003:

Data from the National Agricultural Aviation Association's survey in 2004 show that the average flying time for airplanes in aerial application scenarios on a given day is 3 4 hours. In the present study, mixing loading times ranged from 0.37 to 5.3 hours ( median = 2.33 hours) and application times ranged from 0.68 to 3.82 hours ( median = 1.59 hours). These mixer/ loader and pilot replicate times are not extremely different from the data gathered by the National Agricultural Aviation Association in a survey performed in 2004 with aerial applicators throughout the US ( Reference 5). It is concluded that the times that workers handled propanil during this study were realistic and routine.

VII. CONCLUSIONS The above discussion clearly shows that the worker exposure study with propanil involving passive dosimetry was conducted according to typical current use practices followed in the rice industry. The amounts of product mixed and applied and the exposure times for mixer/ loaders and pilots were typical of propanil uses and more representative of propanil uses than the data currently in PHED for the liquid mixer/ loader and aerial applicator scenarios. There were no special considerations made regarding either the clothing or PPE worn by mixer/ loaders or pilots and the procedures for mixing and transferal of propanil to and from mixing tanks and to airplanes were consistent with industry standards. Because of the consistency in rice industry procedures and practices, the dosimetry data are considered valid measures of worker exposure.

Urine samples from mixer/ loaders and pilots were collected and concentrations of 3,4 DCA were determined. These measurements are adequate as a screening assay for propanil exposure but, in the absence of human pharmacokinetics data, they are not appropriate for the quantification of propanil exposure in humans.

VIII. REFERENCES:

1. El Marbouh, L., Areliano, C., Philibert, C., Evrard, Poey, J and Houin, G. ( 2002). Development and evaluation of an HPLC urinalysis screening test for occupational exposure to 3,4 and 3,5 dichloroanilines. International J. of Clin. Pharmacol and Therapeutics, 40( 1): 41 46.

2. Orlando, J., Branson G. Ayers, and Levitt, P., " The Penetration of Formulated Guthion Spray Through Selected Fabrics", J. Environ. Sci. Health, B16 ( 5): 617 628, ( 1981). 9/ 2004 Page 17 of 17 3. Mumma, R., Brandes, G. A., Brandes G. F., " Exposure of Applicators and Mixer Loaders During Application of Mancozeb by Airplanes, Air Blast Sprayers, and Compressed Air Backpack Sprayers", ACS Symposium Series 273, Edited by R. Honeycutt, G. Zweig, and N. Ragsdale, American Chemical Society, pp 201 220( 1985).

4. Keeble, V., Dupont, P., Doucette, W., Norton, M. " Guthion Penetration of ClothingMaterilas During Mixing and Spraying in Orchards", Performance of Protective Clothing, Edited by S. Mansdorf, R. Sager, and A. Nielsen, American Society for Testing Materials, pp 573 583 ( 1988).

5. Poppendorf. W., Mechanisms of Clothing Exposure and Dermal Dosing During Spray Application", Performance of Protective Clothing, Edited by S. Mansdorf, R. Sager, and A. Nielsen, American Society for Testing Materials, pp 611 624 ( 1988).

6. " Pesticide Use Survey Report for Agricultural Aviation" National Agricultural Aviation Association, Washington, DC ( May 2004).

WDC99 963577 3.058275.0010


[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Rules and Regulations]
[Pages 59810-59813]
[FR Doc No: 2013-23486]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30921; Amdt. No. 3556]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

DATES: This rule is effective September 30, 2013. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of September 30, 2013.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

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

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a),

1 CFR part 51, and Sec.  97.20 of Title 14 of the Code of Federal
Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

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

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR part 97:

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

    Issued in Washington, DC, on September 13, 2013.
John Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

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

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

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

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

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

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

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

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC Date           State             City                 Airport          FDC No.      FDC Date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
10/17/13..............  AK           Koyuk...............  Koyuk Alfred Adams..       2/3762       9/5/13  NDB RWY 1, Amdt 1A
10/17/13..............  AK           Koyuk...............  Koyuk Alfred Adams..       2/3763       9/5/13  NDB/DME RWY 1, Amdt 1A
10/17/13..............  OR           Sunriver............  Sunriver............       3/0191      9/10/13  RNAV (GPS) RWY 18, Orig-A
10/17/13..............  OR           Sunriver............  Sunriver............       3/0192      9/10/13  VOR/DME RWY 18, Amdt 1
10/17/13..............  FL           Fort Lauderdale.....  Fort Lauderdale/           3/0422       9/5/13  RNAV (GPS) Y RWY 28R, Amdt 3A
                                                            Hollywood Intl.
10/17/13..............  GA           Alma................  Bacon County........       3/0528      9/10/13  RNAV (GPS) RWY 33, Orig
10/17/13..............  GA           Alma................  Bacon County........       3/0529      9/10/13  RNAV (GPS) RWY 15, Amdt 1
10/17/13..............  OH           Hamilton............  Butler CO Rgnl......       3/1006      8/29/13  ILS OR LOC RWY 29, Amdt 1A
10/17/13..............  CA           Half Moon Bay.......  Half Moon Bay.......       3/1036      8/29/13  Takeoff Minimums and (Obstacle) DP, Orig
10/17/13..............  CT           Meriden.............  Meriden Markham Muni       3/2626       9/5/13  RNAV (GPS) RWY 36, Orig-A
10/17/13..............  CT           Meriden.............  Meriden Markham Muni       3/2627       9/5/13  VOR RWY 36, Amdt 4A
10/17/13..............  WA           Bellingham..........  Bellingham Intl.....       3/2757      9/10/13  ILS OR LOC RWY 16, ILS RWY 16 (SA CAT I),
                                                                                Amdt 7
10/17/13..............  AK           Savoonga............  Savoonga............       3/3472      8/29/13  VOR/DME RWY 23, Amdt 1A
10/17/13..............  AK           Savoonga............  Savoonga............       3/3474      8/29/13  RNAV (GPS) RWY 23, Amdt 1A
10/17/13..............  AK           Savoonga............  Savoonga............       3/3476      8/29/13  VOR RWY 23, Amdt 1A
10/17/13..............  AK           Savoonga............  Savoonga............       3/3482      8/29/13  RNAV (GPS) RWY 5, Amdt 1
10/17/13..............  OK           Tulsa...............  Tulsa Intl..........       3/3993      9/10/13  RNAV (GPS) RWY 36R, Amdt 1
10/17/13..............  OK           Tulsa...............  Tulsa Intl..........       3/3994      9/10/13  VOR/DME RWY 8, Amdt 4
10/17/13..............  OK           Tulsa...............  Tulsa Intl..........       3/3996      9/10/13  ILS OR LOC RWY 18L, Amdt 15B
10/17/13..............  OK           Tulsa...............  Tulsa Intl..........       3/3999      9/10/13  RNAV (GPS) RWY 18L, Amdt 1A
10/17/13..............  OK           Tulsa...............  Tulsa Intl..........       3/4000      9/10/13  ILS OR LOC RWY 18R, Amdt 7B

10/17/13..............  OK           Tulsa...............  Tulsa Intl..........       3/4001      9/10/13  RNAV (GPS) Y RWY 26, Amdt 3A
10/17/13..............  OK           Tulsa...............  Tulsa Intl..........       3/4002      9/10/13  VOR OR TACAN RWY 26, Amdt 24A
10/17/13..............  OK           Tulsa...............  Tulsa Intl..........       3/4003      9/10/13  RNAV (GPS) RWY 36L, Orig-B
10/17/13..............  OK           Tulsa...............  Tulsa Intl..........       3/4005      9/10/13  ILS OR LOC RWY 36R, Amdt 29B
10/17/13..............  OK           Tulsa...............  Tulsa Intl..........       3/4010      9/10/13  RNAV (GPS) Y RWY 18R, Amdt 1B
10/17/13..............  MI           Escanaba............  Delta County........       3/4011      9/10/13  RNAV (GPS) RWY 9, Orig
10/17/13..............  MI           Escanaba............  Delta County........       3/4012      9/10/13  LOC/DME BC RWY 27, Amdt 1
10/17/13..............  MI           Escanaba............  Delta County........       3/4013      9/10/13  VOR RWY 9, Amdt 14
10/17/13..............  MI           Escanaba............  Delta County........       3/4014      9/10/13  VOR RWY 36, Orig-A
10/17/13..............  MI           Escanaba............  Delta County........       3/4015      9/10/13  VOR RWY 27, Amdt 12
10/17/13..............  MI           Escanaba............  Delta County........       3/4024      9/10/13  ILS OR LOC RWY 9, Amdt 2A
10/17/13..............  MI           Escanaba............  Delta County........       3/4031      9/10/13  RNAV (GPS) RWY 27, Amdt 1
10/17/13..............  OK           Stillwater..........  Stillwater Rgnl.....       3/4057      9/10/13  RNAV (GPS) RWY 17, Orig
10/17/13..............  OK           Stillwater..........  Stillwater Rgnl.....       3/4061      9/10/13  VOR/DME RWY 35, Amdt 1
10/17/13..............  OK           Stillwater..........  Stillwater Rgnl.....       3/4062      9/10/13  NDB RWY 17, Amdt 1
10/17/13..............  OK           Stillwater..........  Stillwater Rgnl.....       3/4075      9/10/13  ILS OR LOC RWY 17, Amdt 2A
10/17/13..............  OK           Stillwater..........  Stillwater Rgnl.....       3/4076      9/10/13  VOR RWY 17, Amdt 14
10/17/13..............  MO           Joplin..............  Joplin Rgnl.........       3/4170      9/10/13  ILS OR LOC/DME RWY 18, Amdt 2
10/17/13..............  MO           Joplin..............  Joplin Rgnl.........       3/4173      9/10/13  RNAV (GPS) RWY 36, Orig
10/17/13..............  MO           Joplin..............  Joplin Rgnl.........       3/4181      9/10/13  LOC BC RWY 31, Amdt 21A
10/17/13..............  MO           Joplin..............  Joplin Rgnl.........       3/4189      9/10/13  RNAV (GPS) RWY 13, Orig
10/17/13..............  MO           Joplin..............  Joplin Rgnl.........       3/4191      9/10/13  ILS OR LOC/NDB RWY 13, Orig
10/17/13..............  IN           Frankfort...........  Frankfort Muni......       3/4259       9/5/13  NDB RWY 9, Amdt 3
10/17/13..............  OR           Corvallis...........  Corvallis Muni......       3/4265      8/29/13  NDB RWY 17, Amdt 2
10/17/13..............  TX           Perryton............  Perryton Ochiltree         3/4294       9/5/13  NDB A, Amdt 4
                                                            County.
10/17/13..............  UT           Salt Lake City......  Salt Lake City Intl.       3/4342      8/29/13  ILS OR LOC RWY 16R, ILS RWY 16R (SA CAT I),
                                                                                ILS RWY 16R (CAT II & III), Amdt 3A
10/17/13..............  CA           Fresno..............  Fresno Yosemite Intl       3/4531      8/29/13  LOC RWY 11L, Amdt 2
10/17/13..............  WA           Pasco...............  Tri-Cities..........       3/4547      8/29/13  RNAV (RNP) Z RWY 21R, Orig
10/17/13..............  WA           Bellingham..........  Bellingham Intl.....       3/4550      9/10/13  RNAV (GPS) Y RWY 16, Amdt 2
10/17/13..............  WA           Bellingham..........  Bellingham Intl.....       3/4558      9/10/13  RNAV (GPS) Y RWY 34, Amdt 1
10/17/13..............  TN           Humboldt............  Humboldt Muni.......       3/4697       9/5/13  VOR/DME-A, Amdt 5
10/17/13..............  AK           Kaltag..............  Kaltag..............       3/4804      8/29/13  RNAV (GPS) RWY 21, Amdt 1
10/17/13..............  MO           Sedalia.............  Sedalia Rgnl........       3/4881      8/29/13  NDB RWY 18, Amdt 8
10/17/13..............  MO           Sedalia.............  Sedalia Rgnl........       3/4882      8/29/13  NDB RWY 36, Amdt 9
10/17/13..............  NJ           Teterboro...........  Teterboro...........       3/4893      8/29/13  RNAV (GPS) Y RWY 6, Amdt 2A
10/17/13..............  AK           Deadhorse...........  Deadhorse...........       3/4995       9/5/13  ILS OR LOC/DME RWY 5, Amdt 2C
10/17/13..............  AR           Dumas...............  Billy Free Muni.....       3/5037      9/10/13  VOR/DME RWY 36, Amdt 3
10/17/13..............  NM           Carlsbad............  Cavern City Air Trml       3/5039       9/5/13  ILS RWY 3, Amdt 4B
10/17/13..............  NM           Carlsbad............  Cavern City Air Trml       3/5040       9/5/13  VOR RWY 32L, Amdt 6
10/17/13..............  MS           Jackson.............  Jackson-Evers Intl..       3/5201      9/10/13  ILS OR LOC RWY 34L, Amdt 6
10/17/13..............  CO           Holyoke.............  Holyoke.............       3/5265      8/29/13  RNAV (GPS) RWY 14, Orig-B
10/17/13..............  CO           Holyoke.............  Holyoke.............       3/5269      8/29/13  RNAV (GPS) RWY 32, Orig-A
10/17/13..............  AK           Anaktuvuk Pass......  Anaktuvuk Pass......       3/5282      8/29/13  NDB B, Amdt 1
10/17/13..............  AK           Anaktuvuk Pass......  Anaktuvuk Pass......       3/5283      8/29/13  RNAV (GPS) A, Amdt 1
10/17/13..............  MS           Meridian............  Key Field...........       3/5382      9/10/13  ILS OR LOC RWY 19, Amdt 1
10/17/13..............  MS           Meridian............  Key Field...........       3/5396      9/10/13  Takeoff Minimums and (Obstacle) DP, Amdt 5
10/17/13..............  AK           Point Hope..........  Point Hope..........       3/5413      8/29/13  NDB RWY 1, Amdt 2
10/17/13..............  AK           Point Hope..........  Point Hope..........       3/5414      8/29/13  NDB RWY 19, Amdt 2
10/17/13..............  AK           Soldotna............  Soldotna............       3/5520       9/5/13  RNAV (GPS) RWY 7, Orig-A
10/17/13..............  AK           Soldotna............  Soldotna............       3/5521       9/5/13  VOR/DME A, Amdt 7C
10/17/13..............  AK           Soldotna............  Soldotna............       3/5523       9/5/13  NDB RWY 7, Amdt 2A
10/17/13..............  AK           Soldotna............  Soldotna............       3/5525       9/5/13  NDB RWY 25, Amdt 3
10/17/13..............  AZ           Kingman.............  Kingman.............       3/5782      8/29/13  RNAV (GPS) RWY 3, Orig
10/17/13..............  AZ           Kingman.............  Kingman.............       3/5783      8/29/13  VOR/DME RWY 21, Amdt 7
10/17/13..............  AZ           Kingman.............  Kingman.............       3/5787      8/29/13  RNAV (GPS) Y RWY 21, Orig
10/17/13..............  AZ           Kingman.............  Kingman.............       3/5790      8/29/13  RNAV (GPS) Z RWY 21, Orig-A
10/17/13..............  GA           Waynesboro..........  Burke County........       3/5868       9/5/13  RNAV (GPS) RWY 8, Orig
10/17/13..............  GA           Waynesboro..........  Burke County........       3/5871       9/5/13  RNAV (GPS) RWY 26, Orig
10/17/13..............  UT           Salt Lake City......  Salt Lake City Intl.       3/6094      8/29/13  LDA/DME RWY 35, Orig
10/17/13..............  MI           Port Huron..........  St Clair County Intl       3/6260      8/29/13  ILS OR LOC RWY 4, Amdt 3B
10/17/13..............  IA           Sioux City..........  Sioux Gateway/Col.         3/6352      9/10/13  ILS OR LOC RWY 31, Amdt 25A
                                                            Bud Day Field.
10/17/13..............  IA           Sioux City..........  Sioux Gateway/Col.         3/6353      9/10/13  VOR OR TACAN RWY 31, Amdt 26B
                                                            Bud Day Field.

10/17/13..............  IA           Sioux City..........  Sioux Gateway/Col.         3/6354      9/10/13  VOR/DME OR TACAN RWY 13, Amdt 18A
                                                            Bud Day Field.
10/17/13..............  IA           Sioux City..........  Sioux Gateway/Col.         3/6355      9/10/13  NDB RWY 31, Amdt 23C
                                                            Bud Day Field.
10/17/13..............  IA           Sioux City..........  Sioux Gateway/Col.         3/6356      9/10/13  NDB RWY 13, Amdt 15E
                                                            Bud Day Field.
10/17/13..............  IA           Sioux City..........  Sioux Gateway/Col.         3/6357      9/10/13  ILS OR LOC RWY 13, Amdt 2
                                                            Bud Day Field.
10/17/13..............  IA           Sioux City..........  Sioux Gateway/Col.         3/6358      9/10/13  NDB RWY 35, Orig-D
                                                            Bud Day Field.
10/17/13..............  CA           Santa Rosa..........  Charles M. Schulz-         3/6496       9/5/13  VOR/DME RWY 14, Amdt 2A
                                                            Sonoma County.
10/17/13..............  CA           Santa Rosa..........  Charles M. Schulz-         3/6498       9/5/13  ILS OR LOC RWY 32, Amdt 18
                                                            Sonoma County.
10/17/13..............  CA           Santa Rosa..........  Charles M. Schulz-         3/6500       9/5/13  VOR RWY 32, Amdt 19
                                                            Sonoma County.
10/17/13..............  OR           Ontario.............  Ontario Muni........       3/6541       9/5/13  NDB RWY 32, Amdt 5
10/17/13..............  OR           Ontario.............  Ontario Muni........       3/6542       9/5/13  RNAV (GPS) RWY 14, Orig
10/17/13..............  OR           Ontario.............  Ontario Muni........       3/6547       9/5/13  RNAV (GPS) RWY 32, Orig
10/17/13..............  CA           Lompoc..............  Lompoc..............       3/6740      9/10/13  VOR/DME A, Amdt 5
10/17/13..............  CO           Montrose............  Montrose Rgnl.......       3/6741       9/5/13  RNAV (GPS) RWY 13, Orig
10/17/13..............  CO           Montrose............  Montrose Rgnl.......       3/6744       9/5/13  RNAV (GPS) Y RWY 17, Orig
10/17/13..............  CO           Montrose............  Montrose Rgnl.......       3/6745       9/5/13  VOR/DME RWY 13, Amdt 9
10/17/13..............  CO           Montrose............  Montrose Rgnl.......       3/6747       9/5/13  RNAV (GPS) RWY 35, Orig
10/17/13..............  CO           Montrose............  Montrose Rgnl.......       3/6749       9/5/13  ILS OR LOC/DME RWY 17, Amdt 2
10/17/13..............  CO           Montrose............  Montrose Rgnl.......       3/6750       9/5/13  RNAV (GPS) Z RWY 17, Orig
10/17/13..............  WI           Fond Du Lac.........  Fond Du Lac County..       3/6783      8/29/13  Takeoff Minimums and (Obstacle) DP, Amdt 1A
10/17/13..............  KS           Wichita.............  Beech Factory.......       3/6894      9/10/13  RNAV (GPS) RWY 19, Amdt 1
10/17/13..............  KS           Wichita.............  Beech Factory.......       3/6896      9/10/13  RNAV (GPS) RWY 1, Amdt 1
10/17/13..............  CA           Redding.............  Redding Muni........       3/7581      8/29/13  Takeoff Minimums and (Obstacle) DP, Amdt 5
10/17/13..............  FL           Orlando.............  Orlando Intl........       3/7948      9/10/13  ILS RWY 17R (CAT II), Amdt 5B
10/17/13..............  FL           Orlando.............  Orlando Intl........       3/7952      9/10/13  ILS RWY 17L (CAT II), Amdt 1B
10/17/13..............  FL           Orlando.............  Orlando Intl........       3/7956      9/10/13  RNAV (GPS) RWY 17L, Orig-A
10/17/13..............  FL           Orlando.............  Orlando Intl........       3/7964      9/10/13  RNAV (GPS) RWY 17R, Orig-A
10/17/13..............  FL           Orlando.............  Orlando Intl........       3/7976      9/10/13  ILS OR LOC RWY 17L, Amdt 1B
10/17/13..............  FL           Orlando.............  Orlando Intl........       3/7978      9/10/13  RNAV (GPS) RWY 18R, Orig-A
10/17/13..............  FL           Orlando.............  Orlando Intl........       3/7984      9/10/13  RNAV (GPS) RWY 18L, Orig-A
10/17/13..............  FL           Orlando.............  Orlando Intl........       3/7986      9/10/13  ILS OR LOC RWY 17R, Amdt 5B
10/17/13..............  FL           Orlando.............  Orlando Intl........       3/7992      9/10/13  ILS OR LOC RWY 18R, Amdt 9B
10/17/13..............  VA           Newport News........  Newport News/              3/8836      9/10/13  RNAV (GPS) RWY 2, Amdt 1
                                                            Williamsburg Intl.
10/17/13..............  VA           Newport News........  Newport News/              3/8841      9/10/13  NDB RWY 20, Amdt 5
                                                            Williamsburg Intl.
10/17/13..............  VA           Newport News........  Newport News/              3/8842      9/10/13  ILS OR LOC RWY 25, Amdt 1
                                                            Williamsburg Intl.
10/17/13..............  VA           Newport News........  Newport News/              3/8843      9/10/13  RNAV (GPS) RWY 25, Amdt 2
                                                            Williamsburg Intl.
10/17/13..............  VA           Newport News........  Newport News/              3/8844      9/10/13  ILS OR LOC RWY 7, Amdt 33
                                                            Williamsburg Intl.
10/17/13..............  VA           Newport News........  Newport News/              3/8845      9/10/13  NDB RWY 2, Amdt 6
                                                            Williamsburg Intl.
10/17/13..............  VA           Newport News........  Newport News/              3/8848      9/10/13  LOC/DME RWY 20, Amdt 1
                                                            Williamsburg Intl.
10/17/13..............  TX           Waco................  Waco Rgnl...........       3/8873      9/10/13  VOR RWY 14, Amdt 23
10/17/13..............  TX           Waco................  Waco Rgnl...........       3/8874      9/10/13  ILS OR LOC RWY 19, Amdt 16
10/17/13..............  TX           Waco................  Waco Rgnl...........       3/8875      9/10/13  VOR/DME RWY 32, Amdt 15
10/17/13..............  TX           Waco................  Waco Rgnl...........       3/8877      9/10/13  RNAV (GPS) RWY 14, Orig
10/17/13..............  TX           Waco................  Waco Rgnl...........       3/8878      9/10/13  RNAV (GPS) RWY 19, Orig
10/17/13..............  VA           Newport News........  Newport News/              3/8963      9/10/13  RNAV (GPS) RWY 20, Amdt 2
                                                            Williamsburg Intl.
10/17/13..............  VA           Danville............  Danville Rgnl.......       3/9267       9/5/13  RNAV (GPS) RWY 20, Orig
10/17/13..............  AK           Homer...............  Homer...............       3/9439      8/29/13  LOC/DME BC RWY 22, Amdt 5
10/17/13..............  TX           Waco................  Waco Rgnl...........       3/9722      9/10/13  RNAV (GPS) RWY 32, Orig-A
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2013-23486 Filed 9-27-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Notices]
[Pages 34733-34734]
[FR Doc No: 2021-13928]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EG21-179-000.
    Applicants: Clover Creek Solar, LLC.
    Description: Notice of Self-Certification of EWG Status of Clover
Creek Solar, LLC.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5106.
    Comments Due: 5 p.m. ET 7/14/21.

    Docket Numbers: EG21-180-000.
    Applicants: Antelope Expansion 1B, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Antelope Expansion 1B, LLC.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5116.
    Comments Due: 5 p.m. ET 7/14/21.

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

    Docket Numbers: ER10-1818-027; ER10-1819-031; ER10-1820-034.
    Applicants: Public Service Company of Colorado; Northern States
Power Company, a Minnesota corporation; Northern States Power Company,
a Wisconsin corporation.
    Description: Notice of Change in Status of Public Service Company
of Colorado, et al.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5096.
    Comments Due: 5 p.m. ET 7/14/21.

    Docket Numbers: ER13-1430-012; ER13-1561-011; ER15-1218-010; ER16-
38-008; ER16-39-007; ER16-2501-004; ER16-2502-004; ER17-2341-004; ER17-
2453-004; ER18-713-003; ER18-1076-003; ER18-1077-003; ER20-2888-002;
ER21-965-001; ER21-1259-001.
    Applicants: Arlington Valley Solar Energy II, LLC, Centinela Solar
Energy, LLC, Solar Star California XIII, LLC, Kingbird Solar A, LLC,
Kingbird Solar B, LLC, Nicolis, LLC, Tropico, LLC, CA Flats Solar 130,
LLC, Imperial Valley Solar 3, LLC, CA Flats Solar 150, LLC, GASNA 6P,
LLC, GASNA 36P, LLC, Townsite Solar, LLC, Ventura Energy Storage, LLC,
Coso Battery Storage, LLC.
    Description: Notice of Non-Material Change in Status of Arlington
Valley Solar Energy II, LLC, et al.
    Filed Date: 6/22/21.
    Accession Number: 20210622-5176.
    Comments Due: 5 p.m. ET 7/13/21.

    Docket Numbers: ER14-1818-021; ER21-1372-001; ER21-1374-001.
    Applicants: Boston Energy Trading and Marketing LLC, Diamond Retail
Energy, LLC, Diamond Energy East, LLC.
    Description: Triennial Market Power Analysis for Central Region of
Boston Energy Trading and Marketing LLC, et al.
    Filed Date: 6/21/21.
    Accession Number: 20210621-5182.
    Comments Due: 5 p.m. ET 8/20/21.

    Docket Numbers: ER21-21-002.
    Applicants: Harts Mill Solar, LLC.
    Description: Compliance filing: Informational Filing Pursuant to
Section 2 of the PJM Tariff to be effective N/A.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5092.
    Comments Due: 5 p.m. ET 7/14/21.

    Docket Numbers: ER21-2183-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3825 Prairie Hills Wind GIA
to be effective 6/14/2021.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5017.
    Comments Due: 5 p.m. ET 7/14/21.

    Docket Numbers: ER21-2185-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original IISA, Service
Agreement No. 6095; Queue No. AE2-224 to be effective 5/28/2021.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5056.
    Comments Due: 5 p.m. ET 7/14/21.

    Docket Numbers: ER21-2186-000.
    Applicants: Duke Energy Florida, LLC.
    Description: Sec.  205(d) Rate Filing: DEF-Gulf Power Conurrence to
Facility Construction Agreement for Affected Sys to be effective 6/17/
2021.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5067.
    Comments Due: 5 p.m. ET 7/14/21.

    Docket Numbers: ER21-2187-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA/CSA,
Service Agreement Nos. 5364 and 5365; Queue No. AB2-160 to be effective
4/16/2019.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5077.
    Comments Due: 5 p.m. ET 7/14/21.

    Docket Numbers: ER21-2188-000.
    Applicants: Stoneray Power Partners, LLC.
    Description: Market-Based Triennial Review Filing: Triennial Market
Power Update--Stoneray Power Partners to be effective 7/1/2021.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5098.
    Comments Due: 5 p.m. ET 8/23/21.

    Docket Numbers: ER21-2189-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA/CSA,
Service Agreement Nos. 5800 and 5834; Queue No. AC1-143 to be effective
9/17/2020.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5100.
    Comments Due: 5 p.m. ET 7/14/21.

    Docket Numbers: ER21-2190-000.
    Applicants: Glaciers Edge Wind Project, LLC.
    Description: Market-Based Triennial Review Filing: Triennial Market
Power Update--Glaciers Edge Wind to be effective 7/1/2021.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5101.
    Comments Due: 5 p.m. ET 8/23/21.

    Docket Numbers: ER21-2191-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 2021-06-23 PSCo-WAPA NITS-
325-0.3.0-Agrmt to be effective 6/24/2021.
    Filed Date: 6/23/21.
    Accession Number: 20210623-5124.
    Comments Due: 5 p.m. ET 7/14/21.

    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>.

Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-13928 Filed 6-29-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 1, 2008 (Volume 73, Number 22)]
[Rules and Regulations]
[Page 6017-6018]
[DOCID:fr01fe08-5]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage Form New Animal Drugs;
Tulathromycin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Pfizer, Inc. The supplemental NADA provides
for veterinarian prescription use of tulathromycin injectable solution
for the treatment of infectious bovine keratoconjunctivitis and the
addition of a pathogen to the indication for use for treatment of swine
respiratory disease.

DATES:  This rule is effective February 1, 2008.

FOR FURTHER INFORMATION CONTACT:  Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed a supplement to NADA 141-244 for DRAXXIN (tulathromycin)

Injectable Solution. The supplemental NADA provides for treatment of
infectious bovine keratoconjunctivitis associated with Moraxella bovis
and the addition of a pathogen, Mycoplasma hyopneumoniae, to the
indication for use for treatment of swine respiratory disease. The
application is approved as of December 28, 2007, and the regulations
are amended in 21 CFR 522.2630 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval.
    The agency has determined under 21 CFR 25.33(a)(1) and (d)(5) that
this action is of a type that does not individually or cumulatively
have a significant effect on the human environment. Therefore, neither
an environmental assessment nor an environmental impact statement is
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  522.2630, revise paragraphs (d)(1)(ii) and (d)(2)(ii) to
read as follows:

Sec.  522.2630  Tulathromycin.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni (Haemophilus somnus), and Mycoplasma
bovis; for the control of respiratory disease in cattle at high risk of
developing BRD associated with M. haemolytica, P. multocida, H. somni,
and M. bovis; and for the treatment of infectious bovine
keratoconjunctivitis (IBK) associated with Moraxella bovis.
* * * * *
    (2) * * *
    (ii) Indications for use. For the treatment of swine respiratory
disease (SRD) associated with Actinobacillus pleuropneumoniae,
Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis,
and Mycoplasma hyopneumoniae.
* * * * *

    Dated: January 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-1906 Filed 1-31-08; 8:45 am]

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