16040 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Notices 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP   2002   0146. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Handle CBI That I Want to Submit 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 person listed under FOR FURTHER INFORMATION CONTACT.

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

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 copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket control 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.

II. Background A. What Action is the Agency Taking?

This notice constitutes and announces the availability of the TRED for tebuthiuron. This decision has been developed as part of the public participation process that EPA and the U. S. Department of Agriculture ( USDA) are using to involve the public in the reassessment of pesticide tolerances under FFDCA. EPA must review tolerances and tolerance exemptions that were in effect when FQPA was enacted in August 1996, to ensure these existing pesticide residues limits for food and feed commodities meet the safety standard of the new law. FFDCA requires EPA to review all the tolerances for registered chemicals in effect on or before the date of the enactment. In reviewing these tolerances, the Agency must consider, among other things, aggregate risks from non occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. The tolerances are considered reassessed once the safety finding has been made or a revocation occurs. FFDCA requires that the Agency, when considering whether to establish, modify, or revoke a tolerance, consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' As indicated above, the Agency will also evaluate the cumulative risk, if necessary, posed by the entire group of chemicals with which a common mechanism of toxicity is shared, and issues a final tolerance reassessment decision once the cumulative assessment for that group is completed. At this time, tebuthiuron has not been identified as sharing a common mechanism of toxicity and is not scheduled for a cumulative risk assessment. The tolerance reassessment program is being conducted under Congressionally mandated time frames, and EPA recognizes both the need to make timely tolerance decisions and to involve the public. Therefore, EPA is issuing this TRED as a final document with a 30   day comment period. All comments will be considered by the Agency. If any comment significantly affects a TRED, EPA will amend the TRED by publishing the amendment in the Federal Register.

B. What is the Agency's Authority for Taking this Action?

The authority for this TRED is found in section 408( q) of the FFDCA, 21 U. S. C. 346a( q). Section 408( q) requires EPA to review tolerances and exemptions for pesticide chemical residues in effect on August 2, 1996, to determine whether the tolerance or exemption meets the requirements of 408( b)( 2) or ( c)( 2). This review is to be completed by August 3, 2006.

List of Subjects Environmental protection, Chemicals, Pesticides and tolerances.

Dated: March 19, 2003. Lois A. Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 03   7981 Filed 4   1   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0097; FRL   7298   7]

Thiamethoxam; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0097, must be received on or before May 2, 2003. 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: Dani Daniel, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   5409; e mail address: daniel. dani@ epa. gov.

SUPPLEMENTARY INFORMATION:

VerDate Jan< 31> 2003 15: 59 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02APN1. SGM 02APN1 16041 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Notices I. General Information A. Does this Action Apply to Me?

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

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

1. EPA Docket. EPA has established an official public docket for this action under docket ID number OPP   2003   0097. 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 Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 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/. 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. EPA 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 on 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 OPP   2003   0097. 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 opp docket@ epa. gov, Attention: Docket ID Number OPP   2003   0097. In contrast to EPA's VerDate Jan< 31> 2003 15: 59 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02APN1. SGM 02APN1 16042 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Notices 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 e mail 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: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID number OPP   2003   0097. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID number OPP   2003   0097. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

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 person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA? 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 copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. 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.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: March 24, 2003. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition The petitioner's summary of the pesticide petitions is printed below as required by FFDCA section 408( d)( 3). The summary of the petitions was prepared by Interregional Research Project 4 ( IR 4) and represents the view of the petitioners. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Interregional Research Project 4 ( IR 4)

Syngenta Crop Ptotection Inc.

PP 2E6505, 2E6363, 2E6508, 3E6524, 1E6349, 9F5051 and 0F6142 This notice is a summary of pesticide petitions proposing the establishment/ amendment of a regulation for residues of thiamethoxam and its metabolite in or on coffee ( imported), pecans, leafy vegetable crop group, head and stem brassica subgroup, leafy brassica subgroup, succulent beans, stone fruit crop group, sunflower seed, peppermint tops and spearmint tops. This summary was prepared by the petitioners. EPA has received seven pesticide petitions; four from Interregional Research Project 4 ( IR 4), 681 U. S. Highway # 1 South, North Brunswick, NJ 08902   3390, PP 2E6505, 2E6363, 2E6508 and 3E6524 and three from Syngenta Crop Protection Inc., P. O. Box 18300, Greensboro, NC 27419   8300, PP 0F6142, 1E6349, and 9F5051 proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR 180.565 by establishing a tolerance for residues of the insecticide thiamethoxam [ 3( chloro 5 thiazolyl) methyl] tetrahydro 5 methyl Nnitro 4H 1,3,5 oxadiazin 4 imine] ( CAS Reg. No. 153719   23   4) and its metabolite N( 2 chloro thiazol 5 ylmethyl) N' methyl  N' nitroguanidine in or on the agricultural commodities:

A. IR 4 Petitions l. PP 2E6505 proposes to establish tolerances for stone fruits, group 12 at 0.5 ppm. 2. PP 2E6363 proposes to establish tolerances for peppermint and spearmint, tops at 4.0 ppm. 3. PP 2E6508 proposes to establish tolerances for beans, succulent at 0.02 ppm. 4. PP 3E6524 proposes to establish tolerances for sunflower, seed at 0.02 ppm.

B. Syngenta Petitions 5. PP 0F6142 proposes to establish tolerances for pecans at 0.02 ppm. 6. PP 9F5051 proposes to establish tolerances for:

VerDate Jan< 31> 2003 15: 59 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02APN1. SGM 02APN1 16043 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Notices   Leafy vegetables, group 4 at 2.0 ppm   Head and stem brassica vegetables, subgroup 5A at 1.0 ppm.

  Leafy brassica vegetables, subgroup 5B at 2.0 ppm. 7. PP 1E6349 proposes to establish tolerances for imported green and roasted coffee beans and instant coffee at 0.05 ppm. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petitions. Additional data may be needed before EPA rules on the petitions.

A. Residue Chemistry 1. Plant metabolism. The primary metabolic pathways of thiamethoxam in plants ( corn, rice, pears, and cucumbers) were similar to those described for animals, with certain extensions of the pathway in plants. Parent compound and CGA   322704 were the major residues in all crops. The metabolism of thiamethoxam in plants and animals is understood for the purposes of the proposed tolerances. Parent thiamethoxam and the metabolite, CGA   322704, are the residues of concern for tolerance setting purposes. 2. Analytical method. Syngenta Crop Protection Inc. has submitted practical analytical methodology for detecting and measuring levels of thiamethoxam in or on raw agricultural commodities. The method is based on crop specific cleanup procedures and determination by liquid chromatography with either ultraviolet ( UV) or mass spectroscopy ( MS) detection. The limit of detection ( LOD) for each analyte of this method is 1.25 nanogram ( ng) injected for samples analyzed by UV and 0.25 ng injected for samples analyzed by MS, and the limit of quantitation ( LOQ) is 0.005 ppm for milk and juices and 0.01 ppm for all other substrates. 3. Magnitude of residues. IR 4 has submitted complete residue data for thiamethoxam on succulent beans, sunflower seed, peppermint and spearmint tops and stone fruits. Syngenta has submitted complete residue data for the proposed imported coffee, pecan, leafy vegetable, head and stem brassica vegetables, leafy brassica vegetables. Details of the Syngenta residue data on these crops were provided in previously published Notices of Filing. B. Toxicological Profile 1. Acute toxicity. The acute oral LD50 for thiamethoxam in the rat is 1,563 milligrams/ kilogram body weight ( mg/ kg bwt). The acute dermal LD50 of thiamethoxam is > 2000 mg/ kg bwt. Thiamethoxam is non toxic at atmospheric concentrations of 3.72 mg/ L. Thiamethoxam is minimally irritating to the eye, non irritating to skin and is not a dermal sensitizer. In an acute neurotoxicity screening study in rats ( OPPTS Harmonized Guideline 870.6200), the no observed aderse affect level ( NOAEL) was 100 mg/ kg/ day with a NOAEL of 500 mg/ kg/ day based on drooped palpebral closure, decrease in rectal temperature and locomotor activity and increase in forelimb grip strength ( males only). At higher dose levels, mortality, abnormal body tone, ptosis, impaired respiration, tremors, longer latency to first step in the open field, crouched over posture, gait impairment, hypo arousal, decreased number of rears, uncoordinated landing during the righting reflex test, slight lacrimation ( females only) and higher mean average input stimulus value in the auditory startle response test ( males only). 2. Genotoxicty. In gene mutation studies with S. typhimurium and E. coli ( OPPTS Harmonized Guidelines, 870.5100 and 870.5265), there was no evidence of gene mutation when tested up to 5,000 µ g/ plate and there was no evidence of cytotoxicity. In a gene mutation study with chinese hamster V79 cells at hypoxanthine guanine phophoribosyl transferase ( HGPRT) focus ( OPPTS Harmonized Guideline 870.5300) there was no evidence of a gene mutation when tested up to the solubility limit. In a CHO cell cytogenetics study ( OPPTS Harmonized Guideline 870.5375) there was no evidence of chromosomal aberrations when tested up to cytotoxic or solubility limit concentrations. An in vivo mouse bone marrow micronucleus study ( OPPTS Harmonized Guideline 870.5395) was negative when tested up to levels of toxicity in whole animals; however, there was no evidence of target cell cytotoxicity. An unscheduled DNA synthesis ( UDS) assay ( OPPTS Harmonized Guideline 870.5550) was negative when tested up to precipitating concentrations. 3. Reproductive and developmental toxicity. A prenatal developmental study in the rat ( OPPTS Harmonized Guideline 870.3700) resulted in maternal and developmental NOAELs of 30 mg/ kg/ day and 200 mg/ kg/ day, respectively. The maternal lowest observed adverse effect level ( LOAEL) is 200 mg/ kg/ day based on decreased body weight, body weight gain and food consumption. The developmental LOAEL was 750 mg/ kg/ day based on decreased fetal body weight and an increased incidence of skeletal anomalies. A prenatal developmental study in the rabbit ( OPPTS Harmonized Guideline 870.3700) resulted in maternal and developmental NOAELs of 50 mg/ kg/ day. The maternal and developmental LOAEL is 150 mg/ kg/ day. The maternal LOAEL is based on maternal deaths, hemorrhagic discharge, decreased body weight and food intake during the dosing period. The developmental LOAEL is based on decreased fetal body weights, increased incidence of post implantation loss and a slight increase in the incidence of a few skeletal anomolies/ variations. In a reproduction and fertility effects study in rats ( OPPTS Harmonized Guideline 870.3800), the parental/ systemic NOAEL is 1.84 ( males), 202.06 ( females) mg/ kg/ day; the reproductive NOAEL is 0.61 ( males), 202.06 ( females) mg/ kg/ day and the offspring NOAEL is 61.25 ( males), 79.20 ( females) mg/ kg/ day. The parental/ systemic LOAEL is 61.25 ( males), not determined ( females) mg/ kg/ day based on increased incidence of hyaline change in renal tubules in F0 and F1 males. The reproductive LOAEL is 1.84 ( males), not determined ( females ) mg/ kg/ day based on increased incidence and severity of tubular atrophy observed in testes of the F1 generation males. The offspring LOAEL is 158.32 ( males), 202.06 ( females) mg/ kg/ day based on reduced body weight gain during the lactation period in all litters. 4. Subchronic toxicity. A 90   day oral toxicity study in rats ( OPPTS Harmonized Guideline 870.3100) resulted in a NOAEL of 1.74 males and 92.5 ( females) mg/ kg/ day. The LOAEL is 17.64 ( male) and 182.1 ( female) mg/ kg/ day based on increased incidence of hyaline change of renal tubules epithelium ( males), fatty change in adrenal gland of females, liver changes in females, all at the LOAEL. A 90   day oral toxicity study in mice ( OPPTS Harmonized Guideline 870.3100) resulted in an NOAEL of 1.41 ( males) and 19.2 ( females) mg/ kg/ day. The LOAEL was 14.3 ( male) and 231 ( female) mg/ kg/ day based on increased incidence of hepatocellular hypertrophy. At higher dose levels: Decrease in body weight and body weight gain, necrosis of individual hepatocytes, pigmentation of Kupffer cells, and lymphocytic infiltration of the VerDate Jan< 31> 2003 15: 59 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02APN1. SGM 02APN1 16044 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Notices liver in both sexes; slight hematologic effects and decreased absolute and relative kidney weights in males; and ovarian atrophy, decreased ovary and spleen weights and increased liver weights in females. In a 90   day oral toxicity study in dogs ( OPPTS Harmonized Guideline 870.3150), the NOAEL is 8.23 ( males) and 9.27 ( females) mg/ kg/ day. The LOAEL is 32.0 ( male) and 33.9 ( female) mg/ kg/ day based on slightly prolonged prothrombin times and decreased plasma albumin and A/ G ration ( both sexes); decreased calcium levels and ovary weights and delayed maturation in the ovaries ( female); decreased cholesterol and phospholipid levels, testis weights, spermatogenesis, and spermatic giant cells in testes ( male). In a 28   day dermal study in rats ( OPPTS Harmonized Guideline 870.3200), the NOAEL was 250 ( male) and 60 ( female) mg/ kg/ day. The LOAEL was 1,000 ( male) and 250 ( female) mg/ kg/ day based on increased plasma glucose, triglyceride levels, and alkaline phosphatase activity and inflammatory cell infiltration in the liver and necrosis if single hepatocytes in females and hyaline change in renal tubules and a very slight reduction in body weight in males. At higher dose levels in females, chronic tubular lesions in the kidneys and inflammatory cell infiltration in the adrenal cortex were observed. In a subchronic neurotoxicity screening study in rats ( OPPTS Harmonized Guideline 870.6200) the NOAEL was 95.4 ( male) and 216.4 ( female) mg/ kg/ day, both at highest dose tested. The LOAEL was not determined. No treatment related observations at any dose level. LOAEL was not achieved. May not have been tested at sufficiently high dose levels; however, a new study is not required because the weight of the evidence from other toxicity studies indicates no evidence of concern. 5. Chronic toxicity. In a chronic toxicity study in dogs ( OPPTS Harmonized Guideline 870.4100) the NOAEL was 4.05 ( male) and 4.49 ( female) mg/ kg/ day. The LOAEL was 21.0 ( male) and 24.6 ( female) mg/ kg/ day based on increase of creatinine in both sexes, transient decrease in food consumption in females, and occasional increase in urea levels, decrease in ALT, and atrophy of seminiferous tubules in males. In a mouse carcinogenicity study ( OPPTS Harmonized Guideline 870.4200), the NOAEL was 2.63 ( male) and 3.68 ( female) mg/ kg/ day. The LOAEL was 63.8 ( male) and 87.6 ( female) mg/ kg/ day based on hepatocyte hypertrophy, single cell necrosis, inflammatory cell infiltration, pigment deposition, foci of cellualr alteration, hyperplasia of kupffer cells and increased mitotic activity, also an increase in the incidence of hepatocellular adenoma ( both sexes). At higher doses, there was an increase in the incidence of hepatocelluar adenocarcinoma ( both sexes) and the number of animals with multiple tumors, evidence of carcinogenicity. In a combined chronic caricinogenicity study in rats ( OPPTS Harmonized Guideline 870.4300) the NOAEL was 21.0 ( male) and 50.3 ( female) mg/ kg/ day. The LOAEL was 63.0 ( male) and 255 ( female) mg/ kg/ day based on increased incidence of lymphocytic infiltration of the renal pelvis and chronic nephropathy in males and decreased body weight gain, slight increase in the severity of hemosiderosis of the spleen, foci of cellular alteration in liver and chronic tubular lesions in kidney in females. No evidence of carcinogenicity. In a hepatic cell proliferation study in mice, the NOAEL was 16 ( male) and 20 ( female) mg/ kg/ day. The LOAEL was 72 ( male) and 87 ( female) mg/ kg/ day based on proliferative activity of hepatocytes. At higher dose levels, increases in absolute and relative liver weights, speckled liver, heptocellular glycogenesis/ fatty change, heptocellular necrosis, apoptosis and pigmentation were observed. In a 28   day feeding study to assess replicative DNA synthesis in the male rat, the NOAEL was 711 mg/ kg/ day. The LOAEL was not established. Immunohistochemical staining of liver sections from control and high dose animals for proliferating cell nuclear antigen gave no indication for a treatment related increase in the fraction of DNA syntesizing hepatocytes in Sphase CGA   293343 did not stimulate hepatocyte cell proliferation in male rats. In a special study to assess liver biochemistry in the mouse, the NOAEL was 17 ( male) and 92 ( female) mg/ kg/ day. The LOAEL was 74 ( male), 92 ( female) mg/ kg/ day based on marginal to slight increases in absolute and relative liver weights, a slight increase in the microsomal protein content of the livers, moderate increases in the cytochrome P450 content, slight to moderate increases in the activity of several microsomal enzymes, slight to moderate induction of cytosolic glutathionw S transfersase activity. Treatment did not affect peroxisomal fatty acid B oxidation. 6. Animal metabolism. The metabolism of thiamethoxam in rats and livestock animals is adequately understood. The residues of concern have been determined to be parent thiamethoxam and its metabolite N( 2 chloro thiazol 5 ylmethyl) N'methyl Nnitro guanidine. 7. Metabolite toxicology. For risk assessment purposes, residues of the metabolite corrected for molecular weight are considered to be toxicologically equivalent to parent thiamethoxam.

C. Aggregate Exposure 1. Dietary exposure. Permanent tolerances have been established ( 40 CFR 180.565) for the combined residues of the insecticide thiamethoxam, 3[( 2 chloro 5 thiazolyl) methyl] tetrahydro 5 methyl N nitro 4H 1,3,5 oxadiazin 4 imine and its metabolite N( 2 chlorothiazol 5 ylmethyl) N' methyl N nitroguanidine in or on a variety of raw agricultural commodities levels ranging from 0.02 parts per million ( ppm) to 1.5 ppm ( including barley, canola, corn, cotton, sorghum, wheat, cucurbit vegetables, fruiting vegetables, pome fruits, tuberous and corm vegetables and livestock commodities). Pending tolerances include coffee ( imported), grapes, raisins, grape juice, pecans, sunflower seed, stone fruits, succulent beans, peppermint and spearmint tops, head and stem brassica, leafy brassica greens and leafy vegetables. Tier III chronic and Tier I acute dietary exposure evaluations were made using the Dietary Exposure Evaluation Model ( DEEMTM), version 7.76 from Exponent. All processing factors were taken from the EPA assessment of August 28, 2000 ( DP Barcode D268606, PC Code 060109). These assessment results include all current tolerances and the proposed tolerances on stone fruit, mint, succulent beans, sunflower seed, pecans, leafy vegetables, leafy brassica vegetables, brassica head and stem vegetables and imported coffee. For the Tier I acute assessment, the proposed tolerance residues for these commodities ( stone fruit, 0.5 ppm; mint, 4.0 ppm; succulent beans, 0.02 ppm; sunflower seed, 0.02 ppm; pecans, 0.02 ppm; leafy vegetables, 2.0 ppm; leafy brassica vegetables, 2.0 ppm; brassica head and stem vegetables, 1.0 ppm; and imported coffee, 0.05 ppm) were used along with the published tolerances for all other commodities. One hundred percent of crop treated was assumed for all commodities in the acute assessment. In the chronic assessments, residue values for secondary animal commodities, pome fruits, ginger, turmeric, peppers, potatoes, wheat and barley were taken from the EPA assessment of August 28, 2000 which VerDate Jan< 31> 2003 15: 59 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02APN1. SGM 02APN1 16045 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Notices uses average field trial residue data with c LOQ substitutions for all nondetectable residues. In addition, a residue value of 0.011 ppm ( c LOQ) and a percent crop treated value of 6.6% were used for all corn commodities. For the remaining registered and the proposed commodities listed above, the following residue data was used in the DEEMTM: Cucurbit, leafy and brassica vegetables and tomatoes  average field trial residues from soil only application residue studies; stone fruits, mint, succulent beans, sunflower seed, and coffee  average field trial residue data with c LOQ substitutions for nondetectable residues; and pecans  the proposed tolerance. In regard to the cucurbit vegetables and tomatoes, the current tolerances are based upon soil and foliar uses; however, Syngenta is currently limiting the use of thiamethoxam in these crops to soil only applications  thus, the refinement in DEEMTM inputs described above. Likewise, the proposed tolerances on leafy vegetables, leafy brassica vegetables and head and stem brassica vegetables are based upon soil and foliar applications of thiamethoxam; however, Syngenta is currently pursuing only the soil application use  thus, the refinement of DEEM inputs described above. Syngenta will pursue foliar applications for these crops at a later date; therefore, the proposed and current tolerances on these crops remain based upon soil and foliar applications. All consumption data for these assessments was taken from the USDA's Continuing Survey of Food Intake by Individuals ( CSFII) with the 1994   96 consumption data base and the supplemental CSFII children's survey ( 1998) consumption data base. For the chronic assessments, the following percent of crop treated values were used for the proposed uses: Coffee, 16.7%; sunflower, 15%; mint, 10%; leaf lettuce, 24.6%; head lettuce, 32%; spinach and cress, 15.6%; all other leafy vegetables, 19.4%; broccoli, 26.2%, cabbage, 15.3%; all other brassica vegetables 17.2%; beans, 20%; stone fruits, 15%; and pecans, 100%. A percent crop treated value of 5% was used for apples and a value of 6.6% was used for all corn commodities. All other percent of crop treated values were taken from the August 28, 2000 EPA assessment. i. Food. For the purposes of assessing the potential dietary exposure under the proposed tolerances, Syngenta Crop Protection has estimated aggregate exposure from all crops for which tolerances are established or proposed. The Tier I acute assessment utilized tolerance values and 100% of crop treated values. The Tier III chronic assessments utilized the residue and percent of crop treated values described above. a. Acute exposure. An acute reference dose of 0.10 mg/ kg bwt/ day for all population subgroups was based on a NOAEL of 100 mg/ kg bwt/ day from an acute neurotoxicity study in rats and an uncertainty factor of 100X ( 100X for combined interspecies and intraspecies variability). An additional Food Quality Protection Act ( FQPA) safety factor of 10X was applied to all population subgroups due to the absence of a developmental neurotoxicity study. For the purpose of aggregate risk assessment, the exposure value was expressed in terms of margin of exposure ( MOE). The MOE was calculated by dividing the NOAEL by the exposure for each population subgroup. In addition, exposure was expressed as a percent of the acute reference dose (% aRfD). Acute exposure to the most exposed subpopulation ( children 1   6 years old) resulted in a MOE of 6,452 ( 15.5% of the aRfD of 0.10 mg/ kg/ bwt/ day) at the 95th percentile of exposure. Since the benchmark MOE for this assessment was 1,000, and since EPA generally has no concern for exposures below 100% of the aRfD, Syngenta believes that there is a reasonable certainty that no harm will result from acute dietary ( food) exposure to residues arising from the current and proposed uses for thiamethoxam chronic exposure. b. Chronic exposure. The chronic reference dose ( cRfD) for thiamethoxam is 0.0006 mg/ kg/ bwt/ day for all population subgroups and is based on a NOAEL of 0.6 mg/ kg/ bwt/ day from a two generation rat reproduction study. An uncertainty factor of 100X ( for combined interspecies and intraspecies variability) and an additional FQPA safety factor of 10X was applied due to evidence of increased susceptibility to young rats following prenatal/ postnatal exposure. Exposure was expressed as MOE and percent of the reference dose (% RfD). Chronic exposure to the most exposed subpopulation ( non nursing infants) resulted in a MOE of 11,538 ( 8.6% of the cRfD of 0.0006 mg/ kg/ bw/ day). Since the benchmark MOE for this assessment was 1,000 and since EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic dietary ( food) exposure to residues arising from the current and proposed uses for thiamethoxam. c. Lifetime exposure. The Q* value for thiamethoxam is 0.0377 ( mg/ kg/ day) 1 and is based on benign and malignant heptocellular tumors in mice in an 18   month carcinogenicity study. Lifetime exposure to the U. S. population resulted in a lifetime risk of 8.17 x 10 7 which represents 81.7% of EPA's lifetime risk limit of 1.0 x 10 6. ii. Drinking water. EPA used the Pesticide Root Zone/ Exposure Analysis Modeling System ( PRZM/ EXAMS) to estimate pesticide concentrations in surface water and SCI GROW, which predicts pesticide concentrations in ground water. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. Based on the SCI GROW and PRZM/ EXAMS models, EPA calculated that estimated environmental concentrations of thiamethoxam at the highest use rate ( 0.125 lb a. i./ acre) are 1.9 parts per billion ( ppb) for acute and chronic exposure to ground water and 11.4 ppb and 0.77 ppb for acute and chronic exposure, respectively, to surface water. Based on field and laboratory data as well as on going prospective ground water monitoring studies, Syngenta believes that the potential exposure to ground water is much lower than that predicted by the conservative SCI GROW model. Preliminary results from the prospective ground water monitoring studies have indicated no detections of thiamethoxam in ground water. EPA determined estimated environmental concentrations ( EECs) are used for comparison to Drinking Water Levels of Comparison ( DWLOC). a. Acute drinking water risk. Acute DWLOCs were calculated based on an acute populated adjusted dose ( aPAD) of 0.1 mg/ kg/ day. For the acute assessment, the children ( 1   6 yrs) subpopulation generated the lowest acute DWLOC of approximately 845 ppb. EPA has determined that the surface water acute EEC is 11.4 ppb and the ground water EEC is 1.9 ppb. Since the surface water value is greater than the ground water value, the surface water value will be used for comparison purposes and will protect for any concerns for ground water concentrations. Since the acute DWLOC of 845 ppb is considerably higher than the acute EEC of 11.4 ppb, Syngenta believes that EPA should not have a concern for acute risk to either surface or ground water.

VerDate Jan< 31> 2003 15: 59 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02APN1. SGM 02APN1 16046 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Notices b. Chronic drinking water risk. Chronic DWLOCs were calculated based on a cPAD of 0.0006 mg/ kg/ day. For the chronic assessment, the non nursing infants subpopulation generated the lowest chronic DWLOC of approximately 5.5 ppb. EPA has determined that the surface water chronic EEC is 0.77 ppb and the ground water EEC is 1.9 ppb. Since the ground water value is greater than the surface water value, the ground water value will be used for comparison purposes and will protect for any concerns for surface water concentrations. Since the chronic DWLOC of 5.5 ppb is higher than the chronic EEC of 1.9 ppb, Syngenta believes that EPA should not have a concern for chronic risk to either surface or ground water. c. Lifetime drinking water risk. Based on currently registered and proposed uses for thiamethoxam, Syngenta has determined a DWLOC of 2.0 ppb. At the currently registered maximum use rate of 0.125 lbs. a. i. per acre per growing season, EPA has used the SCI GROW model to predict a ground water EEC of 1.9 ppb. Thus, the ground water EEC is below the lifetime DWLOC for the general population. The Agency used a screening level model designed to estimate pesticide concentrations in shallow ground water. A number of factors demonstrate that the actual lifetime exposure through drinking water will be less than the lifetime DWLOC. These reasons are as follows:   Thiamethoxam is a systemic pesticide. EPA's Tier I ground water model assumes that all of the product that is applied to the crop is available for run off. Syngenta has submitted data to show that a percentage ( 15   25%) of the product is absorbed by the plant, resulting in that much less product available to leach into ground water. Although, data submitted is on only two crops ( beans and cucumbers), it is likely that the total amount of thiamethoxam available for ground water leaching is less than the amount EPA uses as a model input.   Although, the Agency model is based on aerobic soil half lives, EPA's lifetime risk assessment is for lifetime exposure. Data indicate the anaerobic aquatic half life for thiamethoxam is shorter than the aerobic soil half life and longer than the aerobic aquatic halflife Although, EPA is unable to predict, with a high degree of certainty, what happens to thiamethoxam ground water over time, this does provide some support for the expectation that concentrations in ground water will decline between annual applications.   Shallow ground water modeling is not the perfect model for representing all drinking water from ground water sources. It is likely to be an over estimate of most drinking water concentrations, which tend to originate from deeper sources. EPA's experience is that the model is reasonably accurate for shallow drinking water, but it is less accurate for estimating concentrations in drinking water from deeper sources.   The Agency has established conditions of registration for the previous uses that include two prospective ground water studies and a retrospective monitoring study, so that the reasonable certainty of no harm finding will be sustained. Preliminary results have indicated no detections of thiamethoxam in ground water.   The dietary food risk is based on residue data derived from the average of field trials, which were performed at a higher application rate than what was accepted by EPA. It is not unusual in the Agency's experience for field trial data to be an order of magnitude above actual monitoring. Since thiamethoxam has only recently been registered, actual monitoring data are not yet available. It is likely that the actual risk contribution from food will be much lower than current data indicate, which would result in a larger lifetime DWLOC. Syngenta expects that this refined lifetime DWLOC would be larger than the EECs for the proposed uses. Based on the previous points, Syngenta does not expect that the general population would be exposed to levels exceeding the lifetime DWLOC. 2. Non dietary exposure. Thiamethoxam is not currently registered for use on any sites that would result in residential exposure.

D. Cumulative Effects The potential for cumulative effects of thiamethoxam and other substances that have a common mechanism of toxicity has also been considered. Thiamethoxam belongs to a new pesticide chemical class known as the neonicotinoids. There is no reliable information to indicate that toxic effects produced by thiamethoxam would be cumulative with those of any other chemical including another pesticide. Therefore, Syngenta believes it is appropriate to consider only the potential risks of thiamethoxam in an aggregate risk assessment.

E. Safety Determination Syngenta concludes, as described above, that there is reasonable certainty that no harm to the U. S. population will result from aggregate acute or chronic dietary exposure to thiamethoxam residues including the proposed commodities. F. International Tolerances There are no codex MRLs established for residues of thiamethoxam. [ FR Doc. 03   7803 Filed 4   1   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0102; FRL   7299   6]

Fludioxonil; Notice of Filing Pesticide Petitions to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0102, must be received on or before May 2, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   7610; e mail address: jackson. sidney@ epa. gov.

SUPPLEMENTARY INFORMATION:

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of VerDate Jan< 31> 2003 15: 59 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02APN1. SGM 02APN1


[Federal Register: December 14, 2009 (Volume 74, Number 238)]
[Notices]
[Page 66127-66128]
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. ID-3404-002]

McGrath, Eugene R.; Notice of Filing

December 4, 2009.
    Take notice that on November 23, 2009, Eugene R. McGrath filed an
application for authorization to hold interlocking positions, pursuant
to section 305(b) of the Federal Power Act, 16 USCA 825(b) (2006), and
part 45 of the regulations of the Federal Energy Regulatory Commission,
18 CFR part 45 (2009).
    Any person desiring to intervene or to protest this filing must
file in

accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211, 385.214). Protests will be considered by
the Commission in determining the appropriate action to be taken, but
will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the comment date. On or before the comment
date, it is not necessary to serve motions to intervene or protests on
persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 11, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-29620 Filed 12-11-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: February 9, 2007 (Volume 72, Number 27)]
[Notices]
[Page 6233-6235]
[DOCID:fr09fe07-41]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2004-0015 and EPA-HQ-OAR-2004-0016; FRL-8277-3]

Agency Information Collection Activities; Proposed Collections;
Comment Request; Part 70 Operating Permit Regulations, EPA ICR No.
1587.07, OMB Control No. 2060-0243; Part 71 Federal Operating Permit
Regulations, EPA ICR No. 1713.06, OMB Control No. 2060-0336

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew two existing approved Information Collection
Requests (ICRs) to the Office of Management and Budget (OMB). These
ICRs are scheduled to expire on March 31, 2007. Before submitting these
ICRs to OMB for review and approval, EPA is soliciting comments on
specific aspects of the proposed information collection as described
below.

DATES: Comments must be submitted on or before April 10, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2004-0015 (part 70 ICR) or EPA-HQ-OAR-2004-0016 (part 71 ICR), by
one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (EPA/DC), Air and Radiation Docket Information Center, 1200
Pennsylvania Avenue, NW., Mail Code 2822T, Washington, DC 20460.
     Hand Delivery: EPA Docket Center, EPA West, Room 3334,
1301 Constitution Avenue, NW., Washington, DC 20004. Such deliveries
are accepted only during the Docket's normal hours of operation--8:30
a.m. to 4:30 p.m., Monday through Friday. Special arrangements should
be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2004-0015 or EPA-HQ-OAR-2004-0016. EPA's policy is that all comments
received will be included in the public docket without change and may
be made available online at http://www.regulations.gov including any

personal information provided, unless the comment includes information

claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Do not submit
information that you consider to be CBI or otherwise to be protected
through http://www.regulations.gov or e-mail. The www.regulations.gov Web site

is an ``anonymous access'' system, which means we will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to us without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, we recommend that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, we may
not be able to consider your comment. Electronic files should avoid the
use of special characters or any form of encryption and be free of any
defects or viruses. For additional information about the EPA public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

FOR FURTHER INFORMATION CONTACT: Jeff Herring, Office of Air Quality
Planning and Standards, Air Quality Policy Division (C504-05), U.S.
Environmental Protection Agency, Research Triangle Park, NC 27711;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    The EPA has established public dockets for these ICRs under Docket
ID Nos. EPA-HQ-OAR-2004-0015 (part 70 ICR) and EPA-HQ-OAR-2004-0016
(part 71 ICR) which are available for online viewing at http://www.regulations.gov
, or in person viewing at the Air and Radiation

Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Avenue, NW., Washington, DC 20004. The EPA/DC Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the reading
room is<PHONE_NUMBER>, and the telephone number for the Air and
Radiation Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft collections

of information, submit or view public comments, access the index
listing of the contents of the docket, and to access those documents in
the public docket that are available electronically. Once in the
system, select ``search,'' then key in the docket ID numbers identified
in this document.

What Information Particularly Interests EPA?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that
    EPA could make to reduce the paperwork burden for very small
businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID numbers assigned to these actions in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.

To What Information Collection Activity or ICR Does This Apply?

Docket ID Nos. EPA-HQ-OAR-2004-0015 (part 70 ICR) and EPA-HQ-OAR-
2004-0016 (part 71 ICR).

    Affected entities: Entities potentially affected by this action are
those which must apply for and obtain an operating permit under title V
of the Clean Air Act (Act). These, in general, include sources which
are defined as ``major'' under any title of the Act.
    Titles: Part 70 Operating Permit Regulations; Part 71 Federal
Operating Permit Regulations.
    ICR numbers: For the part 70 regulations, EPA ICR No. 1587.07 and
OMB Control No. 2060-0243. For the part 71 regulations, EPA ICR No.
1713.05 and OMB Control No. 2060-0336.
    ICR status: These ICRs are currently scheduled to expire on March
31, 2007. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: Title V of the Act requires States to develop and
implement a program for issuing operating permits to all sources that
fall under any Act definition of ``major'' and certain other non-major
sources that are subject to Federal air quality regulations. The Act
further requires EPA to develop regulations that establish the minimum
requirements for those State operating permits programs, to oversee
implementation of the State programs, and to operate a Federal
operating permits program in areas not subject to an approved State
program.
    The EPA regulations setting forth requirements for the State
operating permits programs are at part 70, title 40, chapter I of the
Code of Federal Regulations. These are referred to as the ``Part 70
Operating Permit Regulations,'' which are the subject of one of the
ICRs addressed in this notice. The EPA regulations for the Federal
operating permits program are at part 71, title 40, chapter I of the
Code of Federal

Regulations. These are referred to as the ``Part 71 Federal Operating
Permit Regulations,'' which are the subject of the second ICR addressed
in this notice. The part 71 program is being implemented for sources
located in Indian country, Outer Continental Shelf sources, and in
areas that do not have part 70 programs.
    In implementing title V of the Act and EPA's part 70 operating
permits regulations, State and local permitting agencies must develop
programs and submit them to EPA for approval (section 502(d)), and
sources subject to the program must develop operating permit
applications and submit them to the permitting authority within 1 year
after program approval (section 503). Permitting authorities will then
issue permits (section 503(c)) and thereafter enforce, revise, and
renew those permits at no more than 5-year intervals (section 502(d)).
Permit applications and proposed permits will be provided to, and are
subject to review by, EPA (section 505(a)). All information submitted
by a source and the issued permit shall also be available for public
review except for confidential information which will be protected from
disclosure (section 503(e)). Sources will semi-annually submit
compliance monitoring reports to the permitting authorities (section
504(a)). The EPA has the responsibility to oversee implementation of
the program and to administer a Federal operating permits program in
the event a program is not approved for a State (section 502(d)(3)) or
if EPA determines the permitting authority is not adequately
administering its approved program (section 502(i)(4)). The activities
to carry out these tasks are considered mandatory and necessary for
implementation of title V and the proper operation of the operating
permits program. This notice provides updated burden estimates from
previously approved ICRs.
    Burden Statement: The annual public reporting and recordkeeping
burden for the part 70 collection of information is estimated to
average 248 hours per permitted source, and the annual burden for
permitting authorities to administer a part 70 program is estimated to
average 10,179 hours. The annual public reporting and recordkeeping
burden for the part 71 collection of information is estimated to
average 221 hours per permitted source.

Are There Changes in the Estimates From the Last Approval?

    There is an increase of 206 thousand hours in the part 70 total
estimated respondent annual burden compared with that identified in the
ICR currently approved by OMB. This increase in part 70 burden for
sources and permitting authorities is an adjustment due to changes in
burden estimates, primarily an increase in permit renewal activities.
These changes in burden are not program changes, as no federal
mandates, including the part 70 and part 71 regulations, have changed
in any way that would affect these ICRs since the last ICR updates.
    For the part 71 program, there is a decrease of 22 thousand hours
in the total estimated annual burden compared with that identified in
the ICR currently approved by OMB. This burden reduction is also an
adjustment, due to changes in assumptions, primarily due to a reduction
in expected EPA oversight activities for delegated part 71 programs.

What Is the Next Step in the Process for This ICR?

    The EPA will consider the comments received and amend the ICRs as
appropriate. The final ICR packages will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICRs to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about these ICRs or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: January 31, 2007.
Jenny Noonan Edmonds,
Acting Director, Office of Air Quality Planning and Standards.
 [FR Doc. E7-2180 Filed 2-8-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: January 15, 2008 (Volume 73, Number 10)]
[Notices]
[Page 2507-2509]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Advisory Committees; Tentative Schedule of Meetings for 2008

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a
tentative schedule of forthcoming meetings of its public advisory
committees for 2008. During 1991, at the request of the Commissioner of
Food and Drugs (the Commissioner), the Institute of Medicine (the IOM)
conducted a study of the use of FDA's advisory committees. In its final
report, one of the IOM's recommendations was for the agency to publish
an annual tentative schedule of its meetings in the Federal Register.
This publication implements the IOM's recommendation.

FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Advisory Committee
Oversight and Management Staff (HF-4), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The IOM, at the request of the Commissioner,
undertook a study of the use of FDA's advisory committees. In its final
report in 1992, one of the IOM's recommendations was for FDA to adopt a
policy of publishing an advance yearly schedule of its upcoming public
advisory committee meetings in the Federal Register; FDA has
implemented this recommendation. The annual publication of tentatively
scheduled advisory committee meetings will provide both advisory
committee members and the public with the opportunity, in advance, to
schedule attendance at FDA's upcoming advisory committee meetings.
Because the schedule is tentative, amendments to this notice will not
be published in the Federal Register. However, changes to the schedule
will be posted on the FDA advisory committees' Internet site located at
http://www.fda.gov/oc/advisory/default.htm. FDA will continue to

publish a Federal Register notice 15 days in advance of each upcoming
advisory committee meeting, to announce the meeting (21 CFR 14.20).
    The following list announces FDA's tentatively scheduled advisory
committee meetings for 2008. You may also obtain up-to-date information
by calling the Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC area).

------------------------------------------------------------------------
                                                      Advisory Committee
                               Tentative Date of           10-Digit
      Committee Name              Meeting(s)           Information Line
                                                             Code
------------------------------------------------------------------------
OFFICE OF THE COMMISSIONER
------------------------------------------------------------------------
Pediatric Advisory         March and November days<PHONE_NUMBER>
 Committee                  to be announced
------------------------------------------------------------------------
Risk Communication         February 28-29, May 15-<PHONE_NUMBER>
 Advisory Committee         16, August 21-22,
                            November 17-18
------------------------------------------------------------------------
Science Board to FDA       May and October days to<PHONE_NUMBER>
                            be announced
------------------------------------------------------------------------
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
------------------------------------------------------------------------
Allergenic Products        April 29, October 17<PHONE_NUMBER>
 Advisory Committee
------------------------------------------------------------------------
Blood Products Advisory    May 1-2, August 14-15,<PHONE_NUMBER>
 Committee                  December 11-12
------------------------------------------------------------------------
Cellular, Tissue and Gene  April 10-11, November 13-<PHONE_NUMBER>
 Therapies Advisory         14
 Committee
------------------------------------------------------------------------

Transmissible Spongiform   To be announced<PHONE_NUMBER>
 Encephalopathies
 Advisory Committee
------------------------------------------------------------------------
Vaccines and Related       February 20-21, May 21-<PHONE_NUMBER>
 Biological Products        22, September 24-25,
 Advisory Committee         November 19-20
------------------------------------------------------------------------
CENTER FOR DRUG EVALUATION AND RESEARCH
------------------------------------------------------------------------
Anesthetic and Life        March 11, May days to be<PHONE_NUMBER>
 Support Drugs Advisory     announced
 Committee
------------------------------------------------------------------------
Anti-Infective Drugs       February 27-28, April 1-<PHONE_NUMBER>
 Advisory Committee         3
------------------------------------------------------------------------
Antiviral Drugs Advisory   To be announced<PHONE_NUMBER>
 Committee
------------------------------------------------------------------------
Arthritis Advisory         July, September, and<PHONE_NUMBER>
 Committee                  November days to be
                            announced
------------------------------------------------------------------------
Cardiovascular and Renal   June 24-25, August 19-<PHONE_NUMBER>
 Drugs Advisory Committee   20, December 9-10
------------------------------------------------------------------------
Dermatologic and           April days to be<PHONE_NUMBER>
 Ophthalmic Drugs           announced
 Advisory Committee
------------------------------------------------------------------------
Drug Safety and Risk       February 1, May days to<PHONE_NUMBER>
 Management Advisory        be announced
 Committee
------------------------------------------------------------------------
Endocrinologic and         April 16-17, July 1-2,<PHONE_NUMBER>
 Metabolic Drugs Advisory   October 29-30, November
 Committee                  19-20
------------------------------------------------------------------------
Gastrointestinal Drugs     January 23, May days to<PHONE_NUMBER>
 Advisory Committee         be announced
------------------------------------------------------------------------
Nonprescription Drugs      To be announced<PHONE_NUMBER>
 Advisory Committee
------------------------------------------------------------------------
Oncologic Drugs Advisory   March 13, April days to<PHONE_NUMBER>
 Committee                  be announced, May 30,
                            September 10-11,
                            December 15-16
------------------------------------------------------------------------
Peripheral and Central     May days to be announced<PHONE_NUMBER>
 Nervous System Drugs
 Advisory Committee
------------------------------------------------------------------------
Pharmaceutical Science     March 18-19<PHONE_NUMBER>
 and Clinical
 Pharmacology, Advisory
 Committee for
------------------------------------------------------------------------
Psychopharmacologic Drugs  February 6<PHONE_NUMBER>
 Advisory Committee
------------------------------------------------------------------------
Pulmonary-Allergy Drugs    February 20<PHONE_NUMBER>
 Advisory Committee
------------------------------------------------------------------------
Reproductive Health        To be announced<PHONE_NUMBER>
 Drugs, Advisory
 Committee for
------------------------------------------------------------------------
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
------------------------------------------------------------------------
Device Good Manufacturing  August 12, October 20-21<PHONE_NUMBER>
 Practice Advisory
 Committee
------------------------------------------------------------------------
Medical Devices Advisory Committee (Comprised of 18 Panels)
------------------------------------------------------------------------
Anesthesiology and         January 23, March 26,<PHONE_NUMBER>
 Respiratory Therapy        September 17
 Devices Panel
------------------------------------------------------------------------
Circulatory System         August 26-27, November<PHONE_NUMBER>
 Devices Panel              14-15
------------------------------------------------------------------------
Clinical Chemistry and     April 9-10, August 13-<PHONE_NUMBER>
 Clinical Toxicology        14, December 4-5
 Devices Panel
------------------------------------------------------------------------
Dental Products Panel      June 11, September 10,<PHONE_NUMBER>
                            November 19
------------------------------------------------------------------------
Ear, Nose, and Throat      April 16-17, June 25-26,<PHONE_NUMBER>
 Devices Panel              August 28-29, October
                            28-29, December 10-11
------------------------------------------------------------------------
Gastroenterology-Urology   October 17<PHONE_NUMBER>
 Devices Panel
------------------------------------------------------------------------
General and Plastic        June 10-11, October 21-<PHONE_NUMBER>
 Surgery Devices Panel      22
------------------------------------------------------------------------
General Hospital and       May 6-7, September 16-17<PHONE_NUMBER>
 Personal Use Devices
 Panel
------------------------------------------------------------------------
Hematology and Pathology   April 25, October 17<PHONE_NUMBER>
 Devices Panel
------------------------------------------------------------------------
Immunology Devices Panel   November 6-7<PHONE_NUMBER>
------------------------------------------------------------------------
Medical Devices Dispute    To be announced as<PHONE_NUMBER>
 Resolution Panel           needed
------------------------------------------------------------------------
Microbiology Devices       April 24-25, June 19-20,<PHONE_NUMBER>
 Panel                      October 23-24
------------------------------------------------------------------------

Molecular and Clinical     May 6-7, November 11-12<PHONE_NUMBER>
 Genetics Panel
------------------------------------------------------------------------
Neurological Devices       March 25-26, June 3-4,<PHONE_NUMBER>
 Panel                      September 23-24,
                            November 6-7
------------------------------------------------------------------------
Obstetrics and Gynecology  April 17-18, June 19-20,<PHONE_NUMBER>
 Devices Panel              August 14-15, October
                            16-17, December 11-12
------------------------------------------------------------------------
Ophthalmic Devices Panel   February 21-22, May 15-<PHONE_NUMBER>
                            16, September 18-19,
                            November 20-21
------------------------------------------------------------------------
Orthopedic and             April 21-22, June 16-17,<PHONE_NUMBER>
 Rehabilitation Devices     August 18-19, October
 Panel                      20-21, December 8-9
------------------------------------------------------------------------
Radiological Devices       April 15-16, August 12,<PHONE_NUMBER>
 Panel                      November 4
------------------------------------------------------------------------
National Mammography       October 13-14<PHONE_NUMBER>
 Quality Assurance
 Advisory Committee
------------------------------------------------------------------------
Technical Electronic       October 8<PHONE_NUMBER>
 Product Radiation Safety
 Standards Committee
------------------------------------------------------------------------
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
------------------------------------------------------------------------
Food Advisory Committee    July 22, December 2<PHONE_NUMBER>
------------------------------------------------------------------------
CENTER FOR VETERINARY MEDICINE
------------------------------------------------------------------------
Veterinary Medicine        March day to be<PHONE_NUMBER>
 Advisory Committee         announced
------------------------------------------------------------------------
National Center for Toxicological Research (NCTR)
------------------------------------------------------------------------
Science Advisory Board to  August 12-13<PHONE_NUMBER>
 NCTR
------------------------------------------------------------------------

    Dated: January 7, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-567 Filed 1-14-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Proposed Rules]
[Page 63158]
[FR Doc No: 2016-22087]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[EPA-HQ-OW-2015-0392; FRL-9952-39-OW]
RIN 2040-AF61

Water Quality Standards; Establishment of Revised Numeric
Criteria for Selenium for the San Francisco Bay and Delta, State of
California; Extension of Public Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Environmental Protection Agency (EPA) is extending the
comment period for the proposed rule, ``Water Quality Standards;
Establishment of Revised Numeric Criteria for Selenium for the San
Francisco Bay and Delta, State of California.'' In response to
stakeholder requests, EPA is extending the comment period for an
additional 45 days, from September 13, 2016, to October 28, 2016.

DATES: The comment period for the proposed rule that published on July
15, 2016 (81 FR 46030) has been extended. Comments must be received on
or before October 28, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2015-0392, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Julianne McLaughlin, Office of Water,
Standards and Health Protection Division (4305T), U.S. Environmental
Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>or Diane E. Fleck, P.E., Esq., Water
Division (WTR-2-1), U.S. Environmental Protection Agency Region 9, 75
Hawthorne Street, San Francisco, CA 94105; telephone number (415) 972-
3527; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On July 15, 2016, EPA published the proposed
rule, ``Water Quality Standards; Establishment of Revised Numeric
Criteria for Selenium for the San Francisco Bay and Delta, State of
California'' in the Federal Register (81 FR 46030). EPA proposes to
revise the current federal Clean Water Act selenium water quality
criteria applicable to the San Francisco Bay and Delta to ensure that
the criteria are set at levels that protect aquatic life and aquatic-
dependent wildlife, including federally listed threatened and
endangered species.
    The original deadline to submit comments on the proposed rule was
September 13, 2016. This action extends the comment period for 45 days.
Written comments must now be received on or before October 28, 2016.
    For more information on this proposed rule, please visit https://epa.gov/wqs-tech/water-quality-standards-establishment-revised-numeric-criteria-selenium-san-francisco-bay.

    Dated: September 7, 2016.
Michael H. Shapiro,
Deputy Assistant Administrator, Office of Water.
[FR Doc. 2016-22087 Filed 9-13-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 10, 2008 (Volume 73, Number 176)]
[Notices]
[Page 52656-52657]
[DOCID:fr10se08-40]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0669; FRL-8381-9]

Pesticide Program Dialogue Committee Work Group on Web-
Distributed Labeling; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY:  Pursuant to the Federal Advisory Committee Act, EPA gives
notice of a public meeting of the Pesticide Program Dialogue Committee
(PPDC) Work Group on Web-Distributed Labeling on October 2, 2008. An
agenda is under development and will be posted on our website by
September 26, 2008.

DATES: The PPDC meeting will be held on Thursday, October 2, 2008, from
1:30 p.m. to 4:30 p.m.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES: The meeting will be held in room S-12100 on the 12th floor
at One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington,
VA. This location is approximately a half mile from the Crystal City
Metro Station.

FOR FURTHER INFORMATION CONTACT: Michelle DeVaux, Office of Pesticide
Programs (7501P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
fax number:(703) 308-4776; e-mail<EMAIL_ADDRESS>
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 persons who work in agricultural settings or
persons who are concerned about implementation of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA); the Federal Food,
Drug, and Cosmetic Act (FFDCA); and the amendments to both of these
major pesticide laws by the Food Quality Protection Act (FQPA) of 1996.
Potentially affected entities may include, but are not limited to:
Agricultural workers and farmers; pesticide industry and trade
associations; environmental, consumer, and farmworker groups; pesticide
users and growers; pest consultants; State, local and Tribal
governments; academia; public health organizations; food processors;
and the public. If you have questions regarding the applicability of
this action to a particular entity, consult the 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 a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2008-0669. 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. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is(703) 305-5805.
    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.
    A draft agenda is under development and will be posted by September
26, 2008, on EPA's website at:http://www.epa.gov/pesticides/ppdc/.

II. Background

    EPA's Office of Pesticide Programs (OPP) is entrusted with the
responsibility to help ensure the safety of the American food supply,
the education and protection from unreasonable risk of those who apply
or are exposed to pesticides occupationally or through use of products,
and general protection of the environment and special ecosystems from
potential risks posed by pesticides. The Charter for EPA's Pesticide
Program Dialogue Committee (PPDC) was established under the Federal
Advisory Committee Act (FACA), Public Law 92-463, in September 1995,
and was renewed November 2, 2007, for another 2-year period. The
purpose of PPDC is to provide advice and recommendations to the EPA
Administrator on issues associated with pesticide regulatory
development and reform initiatives, evolving public policy and program
implementation issues, and science issues associated with evaluating
and reducing risks from use of pesticides. It is determined that PPDC
is in the public interest in connection with the performance of duties
imposed on the Agency by law. The following sectors are represented on
the PPDC: Pesticide industry and trade associations; environmental/
public interest, consumer, and animal rights groups; farm worker
organizations; pesticide user, grower, and commodity groups; Federal
and State/local/Tribal governments; the general public; academia; and
public health organizations. The objective of the PPDC Work Group on
Web-Distributed Labeling is to provide advice regarding a process to
ensure that the most current version of pesticide labeling is available
to purchasers and users electronically. Copies of the PPDC Charter are
filed with appropriate committees of Congress and the Library of
Congress and are available upon request.

III. How Can I Request to Participate in this Meeting?

    PPDC meetings are open to the public and seating is available on a
first-come basis. Persons interested in attending do not need to
register in advance of the meeting.

List of Subjects

    Environmental protection, Agricultural workers, Agriculture,

Chemicals, Foods, Pesticides and pests, Public health.

    Dated: September 3, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E8-20875 Filed 9-9-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: September 5, 2008 (Volume 73, Number 173)]
[Notices]
[Page 51879-51880]
[DOCID:fr05se08-103]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-25756]

Commercial Driver's License Standards: Application for Exemption;
Volvo Trucks North America (Volvo)

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

ACTION: Notice of application for exemption; request for comments.

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

SUMMARY: FMCSA announces that Volvo Trucks North America (Volvo) has
applied for an exemption from the Federal requirement for a driver of
commercial motor vehicles (CMVs) to hold a commercial driver's license
(CDL). Volvo requests that the exemption cover one Swedish field test
engineer who will test-drive CMVs for Volvo within the United States.
This Volvo employee holds a valid Swedish CDL. Volvo states the
exemption is needed to support a Volvo field test to meet future clean
air standards, to test-drive Volvo prototype vehicles to verify results
in ``real world'' environments, and to deliver the vehicles if
necessary in the United States. Volvo believes the knowledge and skills
tests and training program that Swedish drivers undergo to obtain a
Swedish CDL ensures the exemption would provide a level of safety that
is equivalent to, or greater than, the level of safety obtained by
complying with the U.S. requirements for a CDL.

DATES: Comments must be received on or before October 6, 2008.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA-2006-25756 by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the
instructions for submitting comments on the Federal electronic docket
site.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility; U.S. Department of
Transportation, Room W-12-140, 1200 New Jersey Avenue, SE., 20590-0001.
     Hand Delivery: Ground Floor, Room W12-140, DOT Building,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.
e.t., Monday through Friday, except Federal Holidays.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments and
additional information on the exemption process, see the Public
Participation heading below. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
the ground floor, room W12-140, DOT Building, 1200 New Jersey Avenue,
SE., Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through
Friday, except Federal holidays.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://
www.regulations.gov.
    Public Participation: The http://www.regulations.gov Web site is
generally available 24 hours each day, 365 days each year. You can get
electronic submission and retrieval help and guidelines under the
``help'' section of the http://www.regulations.gov Web site and also at
the DOT's http://docketsinfo.dot.gov Web site. If you want us to notify
you that we received your comments, please include a self-addressed,
stamped envelope or postcard or print the acknowledgement page that
appears after submitting comments online.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Clemente, FMCSA Driver and
Carrier Operations Division; Office of Bus and Truck Standards and
Operations; Telephone:<PHONE_NUMBER>. E-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    Section 4007 of the Transportation Equity Act for the 21st Century
(Pub. L. 105-178, 112 Stat. 107, June 9, 1998) amended 49 U.S.C. 31315
and 31136(e) to provide authority to grant exemptions from motor
carrier safety regulations. Under its regulations, FMCSA must publish a
notice of each exemption request in the Federal Register (49 CFR
381.315(a)). The Agency must provide the public an opportunity to
inspect the information relevant to the application, including the
conducting of any safety analyses. The Agency must also provide an
opportunity for public comment on the application.
    The Agency reviews the safety analyses and the public comments, and

determines whether granting the exemption would likely achieve a level
of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reason for denying or, in the alternative, the
specific person or class of persons receiving the exemption, and the
regulatory provision or provisions from which exemption is granted. The
notice must also specify the effective period of the exemption (up to 2
years), and explain the terms and conditions of the exemption. The
exemption may be renewed (49 CFR 381.300(b)).

Request for Exemption

    Volvo has applied for an exemption from the commercial driver's
license (CDL) rules, specifically 49 CFR 383.23 that prescribes
licensing requirements for drivers operating commercial motor vehicles
(CMVs) in interstate or intrastate commerce. Volvo requests the
exemption because this driver-employee is a citizen and resident of
Sweden, and therefore cannot apply for a CDL in any of the United
States. A copy of the application is in Docket No. FMCSA-2006-25756.
    The exemption would allow one driver to operate CMVs in interstate
commerce as part of a team of drivers who will support a Volvo field
test to meet future air quality standards, to test-drive Volvo
prototype vehicles at its test site and in the vicinity around Phoenix,
Arizona, to verify results in ``real world'' environments, and to
deliver the vehicles if necessary in the U.S. The driver is Fredrik
Eriksson, and Volvo requests that the exemption cover a 2-year period
beginning February 2009.
    This driver holds a valid Swedish CDL, and as explained by Volvo in
previous exemption requests, drivers applying for a Swedish-issued CDL
mustdergo a training program and pass knowledge and skills tests. Volvo
also stated in prior exemption requests that the knowledge and skills
tests and training program that Swedish drivers undergo to obtain a
Swedish CDL ensure the exemption provides a level of safety that is
equivalent to, or greater than, the level of safety obtained by
complying with the U.S. requirement for a CDL.
    FMCSA has previously determined the process for obtaining a
Swedish-issued CDL is comparable to, or as effective as the Federal
requirements of Part 383, and adequately assesses the driver's ability
to operate CMVs in the U.S. On other prior occasions FMCSA has
published notices concerning similar Volvo requests. The initial notice
of a similar nature was published by FMCSA on May 12, 2006, granting
this exemption to Volvo for 11 Swedish CDL drivers permitting them to
operate CMVs in the U.S. (71 FR 27780).

Request for Comments

    In accordance with 49 U.S.C. 31315(b)(4) and 31136(e), FMCSA
requests public comment on Volvo's application for an exemption from
the CDL requirements of 49 CFR 383.23. The Agency will consider all
comments received by close of business on October 6, 2008. Comments
will be available for examination in the docket at the location listed
under the ``ADDRESSES'' section of this notice. The Agency will
consider to the extent practicable comments received in the public
docket after the closing date of the comment period.

    Issued on: August 29, 2008.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E8-20667 Filed 9-5-08; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 44 (Tuesday, March 7, 2023)]
[Proposed Rules]
[Page 14092]
[FR Doc No: 2023-04658]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 21, 25, and 29

[Docket No. FAA-2023-0515]

Draft Policy Statement Regarding Submission of Outline of New and
Changed Systems at the Beginning of the Type Certificate Amendment
Process for Transport Category Aircraft; Correction

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notification of availability, request for comments; correction.

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

SUMMARY: The FAA published a document in the Federal Register on March
2, 2023, inviting the public to submit comments on the draft policy
statement regarding Submission of Outline of New and Changed Systems at
the Beginning of the Type Certificate Amendment Process for Transport
Category Aircraft. The document contained an incorrect uniform resource
locator (URL).

DATES: This correction is effective on March 7, 2023.

FOR FURTHER INFORMATION CONTACT: Sue McCormick, Strategic Policy
Systems Standards Section, AIR-619, Strategic Policy Management Branch,
Policy and Innovation Division, Aircraft Certification Service, by
email at [email protected], or by phone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    Draft Policy Statement Regarding Submission of Outline of New and
Changed Systems at the Beginning of the Type Certificate Amendment
Process for Transport Category Aircraft, was published in the Federal
Register on March 2, 2023 (88 FR 13071). The original document
contained an incorrect URL for Aviation Safety Draft Documents Open for
Comment.

Correction

    In the Federal Register of March 2, 2023 (88 FR 13071), make the
following correction:
    1. On page 13071, in the SUPPLEMENTARY INFORMATION, Discussion
section, third sentence, correct the URL to read ``https://www.faa.gov/
aircraft/draft_docs''.

    Issued in Washington, DC, on March 2, 2023.
James D. Foltz,
Acting Manager, Strategic Policy Management Branch, Policy and
Innovation Division, Aircraft Certification Service.
[FR Doc. 2023-04658 Filed 3-6-23; 8:45 am]
BILLING CODE 4910-13-P