42030 Federal Register / Vol. 68, No. 136 / Wednesday, July 16, 2003 / Notices employee work practices. As long as the recommended practices for worker protection during use are respected, the risk of worker exposure to gellan gum in an occupational setting is expected to be of minimal significance. 2. Infants and children. The exposure to gellan gum in pesticide formulations is limited to formulators and applicators. Dietary exposure to infants and children does not differ from the general population.

F. International Tolerances Gellan gum is approved, registered, or filed as a food additive in the countries of Argentina, Brazil, Canada, Chile, Columbia, Costa Rica, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay, Venezuela, Egypt, Hungary, Israel, Jordan, Morocco, Norway, Pakistan, Poland, South Africa, Switzerland, Tunisia, Turkey, Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Malta, New Zealand, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, the Philippines, and Vietnam. In the European community, gellan gum has approval ( E   418) as a food additive. Purity criteria are established by JECFA ( Joint Expert Committee on Food Additives). [ FR Doc. 03   17897 Filed 7   15   03; 8: 45 am]

BILLING CODE 6560   50   S]

ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0225; FRL   7314   7]

Zeta cypermethrin and its inactive isomers; 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   0225, must be received on or before August 15, 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: Linda A. DeLuise, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   5428; e mail address: deluise. linda@ epa. gov@ 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. Potentially affected entities may include, but are not limited to:   Crop protection ( 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. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0225. 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 EPA's 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 in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public VerDate Jan< 31> 2003 17: 58 Jul 15, 2003 Jkt 200001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 16JYN1. SGM 16JYN1 42031 Federal Register / Vol. 68, No. 136 / Wednesday, July 16, 2003 / Notices 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   0225. 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   0225. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your 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   0225. 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   0225. 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 contain 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.

VerDate Jan< 31> 2003 17: 58 Jul 15, 2003 Jkt 200001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 16JYN1. SGM 16JYN1 42032 Federal Register / Vol. 68, No. 136 / Wednesday, July 16, 2003 / Notices Dated: July 3, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs.

Summary of Petition The petitioner's summary of the pesticide petition is printed below as required by FFDCA section 408( d)( 3). The summary of the petition was prepared by the petitioner and represents the view of the petitioner. 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.

FMC Corporation PP 3F6577 EPA has received pesticide petition ( 3F6577) from FMC Corporation, 1735 Market Street, Philadelphia, PA 19103, proposing pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR 180.418 by establishing a tolerance for residues of the insecticide zeta cypermethrin ( ±  a cyano( 3 phenoxyphenyl) methyl ( ± ) cis, trans 3 ( 2,2 dichloroethenyl) 2,2 dimethylcyclopropanecarboxylate) and its inactive isomers in or on the raw agricultural commodity fruit, pome, group 11, at 0.6 ppm and fruit, stone, group 12, at 0.9 ppm. EPA has determined that the petition contains 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 petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. The metabolism of cypermethrin in plants is adequately understood. Studies have been conducted to delineate the metabolism of radiolabeled cypermethrin in various crops all showing similar results. The residue of concern is the parent compound only. 2. Analytical method. There is a practical analytical method for detecting and measuring levels of cypermethrin in or on food with a limit of detection ( LOD) that allows monitoring of food with residues at or above the levels set in these tolerances ( gas chromatography with electron capture detection ( GC/ ECD)). 3. Magnitude of residues. Crop field trial residue data from studies conducted at the maximum label rates for representative commodities for pome fruit and stone fruit crop groups root, show that the proposed zetacypermethrin tolerances on fruit, pome, group 11, at 0.6 ppm and fruit, stone, group 12, at 0.9 ppm; will not be exceeded when the zeta cypermethrin products labeled for these uses are used as directed.

B. Toxicological Profile 1. Acute toxicity. For the purposes of assessing acute dietary risk, FMC Corporation has used the no observed adverse effect level ( NOAEL) of 10.0 milligrams/ kilogram/ day ( mg/ kg/ day) from the zeta cypermethrin acute neurotoxicity study in rats. The lowest observed adverse effect level ( LOAEL) of 50.0 mg/ kg/ day was based on clinical signs. This acute dietary endpoint is used to determine acute dietary risks to all population subgroups. 2. Genotoxicity. The following genotoxicity tests were all negative: In vivo chromosomal aberration in rat bone marrow cells; in vitro cytogenic chromosome aberration; unscheduled DNA synthesis ( UDS); Chinese Hampster Ovary/ Hypoxanthine Guanine Phophoribosyl Transferase ( CHO/ HGPRT) mutagen assay; weakly mutagenic: gene mutation ( Ames). 3. Reproductive and developmental toxicity. No evidence of additional sensitivity to young rats was observed following prenatal or postnatal exposure to zeta cypermethrin. i. A 2 generation reproductive toxicity study with zeta cypermethrin in rats demonstrated a NOAEL of 7.0 mg/ kg/ day and a LOAEL of 27.0 mg/ kg/ day for parental/ systemic toxicity based on body weight, organ weight, and clinical signs. There were no adverse effects in reproductive performance. The NOAEL for reproductive toxicity was considered to be > 45.0 mg/ kg/ day ( the highest dose tested ( HDT)). ii. A developmental study with zetacypermethrin in rats demonstrated a maternal NOAEL of 12.5 mg/ kg/ day and a LOAEL of 25 mg/ kg/ day based on decreased maternal body weight gain, food consumption, and clinical signs. There were no signs of developmental toxicity at 35.0 mg/ kg/ day, the HDT level. iii. A developmental study with cypermethrin in rabbits demonstrated a maternal NOAEL of 100 mg/ kg/ day and a LOAEL of 450 mg/ kg/ day based on decreased body weight gain. There were no signs of developmental toxicity at 700 mg/ kg/ day, the HDT level. 4. Subchronic toxicity. Short term and intermediate term toxicity ( incidental oral exposure). The NOAEL of 10.0 mg/ kg/ day based on clinical signs at the lowest effect level ( LEL) of 50.0 mg/ kg/ day in the zeta cypermethrin acute neurotoxicity study in rats would also be used for short term percent acute population adjusted dose ( PAD) and margin of exposure ( MOE) calculations ( as well as acute, discussed in ( 1) above), and the NOAEL of 5.0 mg/ kg/ day based on decreased motor activity in the zeta cypermethrin subchronic neurotoxicity study in rats, would be used for intermediate term MOE calculations. 5. Chronic toxicity   i. The chronic reference dose ( RfD) of 0.06 mg/ kg/ day for zeta cypermethrin is based on a NOAEL of 6.0 mg/ kg/ day from a cypermethrin chronic feeding study in dogs and an uncertainty factor ( UF) of 100. The endpoint effect of concern was based on clinical signs. ii. Cypermethrin is classified as a Group C chemical ( possible human carcinogen with limited evidence of carcinogenicity in animals) based upon limited evidence for carcinogenicity in female mice; assignment of a Q* has not been recommended. 6. Animal metabolism. The metabolism of cypermethrin in animals is adequately understood. Cypermethrin has been shown to be rapidly absorbed, distributed, and excreted in rats when administered orally. Cypermethrin is metabolized by hydrolysis and oxidation. 7. Metabolite toxicology. The Agency has previously determined that the metabolites of cypermethrin are not of toxicological concern and need not be included in the tolerance expression nor in the risk exposure assessments. 8. Endocrine disruption. No special studies investigating potential estrogenic or other endocrine effects of cypermethrin have been conducted. However, no evidence of such effects were reported in the standard battery of required toxicology studies which have been completed and found acceptable. Based on these studies, there is no evidence to suggest that cypermethrin has an adverse effect on the endocrine system.

C. Aggregate Exposure 1. Dietary exposure   i. Food. Permanent tolerances, in support of registrations, currently exist for residues of zeta cypermethrin on: Alfalfa hay, alfalfa forage, alfalfa seed, aspirated grain fractions, sugar beets ( roots and tops), head, stem and leafy brassica vegetables, cabbage, field corn grain, pop corn grain, field corn forage, field corn stover, pop corn stover, sweet corn ( K+ CWHR), sweet corn forage, sweet corn stover, cottonseed, dried shelled peas and beans, edible podded legume VerDate Jan< 31> 2003 17: 58 Jul 15, 2003 Jkt 200001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 16JYN1. SGM 16JYN1 42033 Federal Register / Vol. 68, No. 136 / Wednesday, July 16, 2003 / Notices vegetables, fruiting vegetables ( except cucurbits), leafy vegetables, head lettuce, bulb and green onions, pecans, rice grain, rice hulls, rice straw, sorghum forage, sorghum grain, sorghum stover, soybean seed, succulent shelled peas and beans, sugarcane, wheat forage, wheat grain, wheat hay, wheat straw, meat, fat, and meat byproducts of cattle, goats, hogs, horses, and poultry, eggs, milk and milk fat. For the purposes of assessing the potential dietary exposure for these existing and the subject proposed tolerances, FMC Corporation has utilized available information on anticipated residues, monitoring data and percent crop treated as follows: i. Acute exposure and risk. Acute dietary exposure risk assessments are performed for a food use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1   day or single exposure. For the purposes of assessing acute dietary risk for zeta cypermethrin, FMC Corporation has used the NOAEL of 10.0 mg/ kg/ day from the zetacypermethrin acute neurotoxicity study in rats with an UF of 100 ( acute RfD = 0.10 mg/ kg/ day). The LEL of 50.0 mg/ kg/ day was based on clinical signs. This acute dietary endpoint is used to determine acute dietary risks to all population subgroups. Available information on anticipated residues, monitoring data and percent crop treated was incorporated into a Tier 3 analysis, using Monte Carlo modeling for commodities that may be consumed in a single serving. These assessments show that the percent acute PAD all fall below EPA's level of concern (  100%). The 95th percentile of exposure for the overall U. S. population was estimated to be 0.001177 mg/ kg/ day ( percent acute RfD of 1.2); 99th percentile 0.003307 mg/ kg/ day ( percent acute RfD of 3.3); and 99.9th percentile 0.012692 mg/ kg/ day ( percent acute RfD of 12.7). The 95th percentile of exposure for all infants < 1   year old was estimated to be 0.002441 mg/ kg/ day ( percent acute RfD of 2.4); 99th percentile 0.011178 mg/ kg/ day ( percent acute RfD of 11.2); and 99.9th percentile 0.029462 mg/ kg/ day ( percent acute RfD of 29.5). The 95th percentile of exposure for nursing infants < 1   year old was estimated to be 0.001247 mg/ kg/ day ( percent acute RfD of 1.3); 99th percentile 0.004540 mg/ kg/ day ( percent acute RfD of 4.5); and 99.9th percentile 0.011659 mg/ kg/ day ( percent acute RfD of 11.7). The 95th percentile of exposure for non nursing infants < 1   year old ( the most highly exposed population subgroup) was estimated to be 0.002786 mg/ kg/ day ( percent acute RfD of 2.8); 99th percentile 0.012899 mg/ kg/ day ( percent acute RfD of 12.9); and 99.9th percentile 0.033071 mg/ kg/ day ( percent acute RfD of 33.1). The 95th percentile of exposure for children 1 to 6 years old and children 7 to 12 years old was estimated to be, respectively, 0.001942 mg/ kg/ day ( percent acute RfD of 1.9) and 0.001244 mg/ kg/ day ( percent acute RfD of 1.2); 99th percentile 0.005670 mg/ kg/ day ( percent acute RfD of 5.7) and 0.003082 ( percent acute RfD of 3.1); and 99.9th percentile 0.018280 mg/ kg/ day ( percent acute RfD of 18.3) and 0.009335 ( percent acute RfD of 9.3). The 95th percentile of exposure for females ( 13+/ nursing) was estimated to be 0.001128 mg/ kg/ day ( percent acute RfD of 1.1); 99th percentile 0.003112 mg/ kg/ day ( percent acute RfD of 3.1); and 99.9th percentile 0.012903 mg/ kg/ day ( percent acute RfD of 12.9). Therefore, FMC Corporation concludes that the acute dietary risk of zeta cypermethrin, as estimated by the dietary risk assessment, does not appear to be of concern. ii. Chronic exposure and risk. The chronic RfD of 0.06 mg/ kg/ day for zetacypermethrin is based on a NOAEL of 6.0 mg/ kg/ day from a cypermethrin chronic feeding study in dogs and an UF of 100. The endpoint effect of concern was based on clinical signs. A chronic dietary exposure/ risk assessment has been performed for zeta cypermethrin using the above chronic RfD. Available information on anticipated residues, monitoring data and percent crop treated was incorporated into the analysis to estimate the anticipated residue contribution ( ARC). The ARC is generally considered a more realistic estimate than an estimate based on tolerance level residues. The ARC is estimated to be 0.000184 mg/ kg body weight ( bwt)/ day and utilize 0.3% of the chronic RfD for the overall U. S. population. The ARC for non nursing infants (< 1   year) ( subgroup most highly exposed) is estimated to be 0.000666 mg/ kg bwt/ day and utilizes 1.1% of the chronic RfD, respectively. The ARCs for children 1 to 6 years old and children 7 to 12 years old are estimated to be 0.000477 mg/ kg bwt/ day and 0.000254 mg/ kg bwt/ day and utilizes 0.8% and 0.4% of the chronic RfD, respectively. The ARC for females ( 13+/ nursing) is estimated to be 0.000180 mg/ kg bwt/ day and utilizes 0.3% of the RfD. Generally speaking, EPA has no cause for concern if the total dietary exposure from residues for uses for which there are published and proposed tolerances is less than 100% of the chronic RfD. Therefore, FMC Corporation concludes that the chronic dietary risk of zetacypermethrin as estimated by the dietary risk assessment, does not appear to be of concern. iii. Drinking water. Laboratory and field data have demonstrated that cypermethrin is immobile in soil and will not leach into ground water. Other data show that cypermethrin is virtually insoluble in water and extremely lipophilic. As a result, FMC Corporation concludes that residues reaching surface waters from field runoff will quickly adsorb to sediment particles and be partitioned from the water column. Drinking water estimated concentrations ( DWECs) and the corresponding drinking water level of comparison ( DWLOCs) values were calculated for chronic and acute exposures. The results show that all DWLOC values exceed the DWEC values. Thus, exposure to zeta cypermethrin and cypermethrin residues in drinking water is not of concern. EPA's draft Standard Operating Procedures ( SOP) for incorporating estimates of drinking water exposure into aggregate risk assessments was used to perform a drinking water analysis. This SOP utilizes a variety of tools to conduct drinking water assessment. These tools include water models such as ( Food Quality Protection Act ( FQPA) FQPA Index Reservoir Screening Tool ( FIRST)), EPA Pesticide Root Zone Model/ Exposure Analysis Modeling System ( PRZM/ EXAMS), Screening Concentration in Groundwater ( SCIGROW and monitoring data. If monitoring data are not available then the models are used to predict potential residues in drinking water. The technique recommended in drinking water SOP compares a calculated DWLOC value to the DWEC value. The DWEC value results from either the monitoring data residues or modeled water residues. If the DWLOC value exceeds the DWEC value then there is reasonable certainty that no harm will result from the acute or chronic aggregate exposure. In the case of cypermethrin and zetacypermethrin monitoring data do not exist. Therefore, the FIRST model was used to estimate a surface water residue. The risk assessment for drinking water compares two values: The DWLOC and the DWEC. The DWLOC is the maximum allowable drinking water concentration ( in part per billion ( ppb)). The DWEC is derived either from monitoring studies or from modeling. If the DWLOC is greater than the DWEC, then the overall exposure from water, food, and residential is considered to be acceptable. The calculated DWLOC values for acute and chronic exposures for all adults, adult females, and VerDate Jan< 31> 2003 17: 58 Jul 15, 2003 Jkt 200001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 16JYN1. SGM 16JYN1 42034 Federal Register / Vol. 68, No. 136 / Wednesday, July 16, 2003 / Notices children exceed the modeled DWEC surface water residues. Therefore, there is reasonable certainty that no harm will result from cumulative and aggregate ( food and water) exposure to cypermethrin and zeta cypermethrin residues. 2. Non dietary exposure. Zetacypermethrin is registered for agricultural crop applications only, therefore non dietary exposure assessments are not warranted.

D. Cumulative Effects In consideration of potential cumulative effects of cypermethrin and other substances that may have a common mechanism of toxicity, to our knowledge there are currently no available data or other reliable information indicating that any toxic effects produced by cypermethrin would be cumulative with those of other chemical compounds; thus only the potential risks of cypermethrin have been considered in this assessment of its aggregate exposure. FMC Corporation intends to submit information for EPA to consider concerning potential cumulative effects of cypermethrin consistent with the schedule established by EPA in the Federal Register of August 4, 1997 ( 62 FR 42020) ( FRL   5734   6) and other EPA publications pursuant to the FQPA.

E. Safety Determination 1. U. S. population. The chronic RfD of 0.06 mg/ kg/ day for zeta cypermethrin is based on a NOAEL of 6.0 mg/ kg/ day from a cypermethrin chronic feeding study in dogs and an UF of 100. The endpoint effect of concern was based on clinical signs. A chronic dietary exposure/ risk assessment has been performed for zeta cypermethrin using the above chronic RfD. Available information on anticipated residues, monitoring data and percent crop treated was incorporated into the analysis to estimate the ARC. The ARC is generally considered a more realistic estimate than an estimate based on tolerance level residues. The ARC is estimated to be 0.000184 mg/ kg bwt/ day and utilize 0.3% of the chronic RfD for the overall U. S. population. The ARC for non nursing infants (< 1   year) ( subgroup most highly exposed) is estimated to be 0.000666 mg/ kg bwt/ day and utilizes 1.1% of the chronic RfD, respectively. The ARCs for children 1 to 6 years old and children 7 to 12 years old are estimated to be 0.000477 mg/ kg bwt/ day and 0.000254 mg/ kg bwt/ day and utilizes 0.8% and 0.4% of the chronic RfD, respectively. The ARC for females ( 13+/ nursing) is estimated to be 0.000180 mg/ kg bwt/ day and utilizes 0.3% of the RfD. Generally speaking, EPA has no cause for concern if the total dietary exposure from residues for uses for which there are published and proposed tolerances is less than 100% of the chronic RfD. Therefore, FMC Corporation concludes that the chronic dietary risk of zeta cypermethrin, as estimated by the dietary risk assessment, does not appear to be of concern. Acute dietary exposure risk assessments are performed for a fooduse pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1   day or single exposure. For the purposes of assessing acute dietary risk for zetacypermethrin FMC Corporation has used the NOAEL of 10.0 mg/ kg/ day from the zeta cypermethrin acute neurotoxicity study in rats with an UF of 100 ( acute RfD = 0.10 mg/ kg/ day). The LEL of 50.0 mg/ kg/ day was based on clinical signs. This acute dietary endpoint is used to determine acute dietary risks to all population subgroups. Available information on anticipated residues, monitoring data and percent crop treated was incorporated into a Tier 3 analysis, using Monte Carlo modeling for commodities that may be consumed in a single serving. These assessments show that the percent acute ( percent PAD) all fall below EPA's level of concern (  100%). The 95th percentile of exposure for the overall U. S. population was estimated to be 0.001177 mg/ kg/ day ( percent acute RfD of 1.2); 99th percentile 0.003307 mg/ kg/ day ( percent acute RfD of 3.3); and 99.9th percentile 0.012692 mg/ kg/ day ( percent acute RfD of 12.7). The 95th percentile of exposure for all infants < 1   year old was estimated to be 0.002441 mg/ kg/ day ( percent acute RfD of 2.4); 99th percentile 0.011178 mg/ kg/ day ( percent acute RfD of 11.2); and 99.9th percentile 0.029462 mg/ kg/ day ( percent acute RfD of 29.5). The 95th percentile of exposure for nursing infants < 1   year old was estimated to be 0.001247 mg/ kg/ day ( percent acute RfD of 1.3); 99th percentile 0.004540 mg/ kg/ day ( percent acute RfD of 4.5); and 99.9th percentile 0.011659 mg/ kg/ day ( percent acute RfD of 11.7). The 95th percentile of exposure for non nursing infants < 1   year old ( the most highly exposed population subgroup) was estimated to be 0.002786 mg/ kg/ day ( percent acute RfD of 2.8); 99th percentile 0.012899 mg/ kg/ day ( percent acute RfD of 12.9); and 99.9th percentile 0.033071 mg/ kg/ day ( percent acute RfD of 33.1). The 95th percentile of exposure for children 1 to 6 years old and children 7 to 12 years old was estimated to be, respectively, 0.001942 mg/ kg/ day ( percent acute RfD of 1.9) and 0.001244 mg/ kg/ day ( percent acute RfD of 1.2); 99th percentile 0.005670 mg/ kg/ day ( percent acute RfD of 5.7) and 0.003082 ( percent acute RfD of 3.1); and 99.9th percentile 0.018280 mg/ kg/ day ( percent acute RfD of 18.3) and 0.009335 ( percent acute RfD of 9.3). The 95th percentile of exposure for females ( 13+/ nursing) was estimated to be 0.001128 mg/ kg/ day ( percent acute RfD of 1.1); 99th percentile 0.003112 mg/ kg/ day ( percent acute RfD of 3.1); and 99.9th percentile 0.012903 mg/ kg/ day ( percent acute RfD of 12.9). Therefore, FMC Corporation concludes that the acute dietary risk of zeta cypermethrin, as estimated by the dietary risk assessment, does not appear to be of concern. 2. Infants and children   i. General. In assessing the potential for additional sensitivity of infants and children to residues of zeta cypermethrin, FMC Corporation considered data from developmental toxicity studies in the rat and rabbit, and a 2   generation reproductive study in the rat. The data demonstrated no indication of increased sensitivity of rats to zeta cypermethrin or rabbits to cypermethrin in utero and/ or postnatal exposure to zetacypermethrin or cypermethrin. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from pesticide exposure during prenatal development to one or both parents. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity. FFDCA section 408 provides that EPA may apply an additional margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base. ii. Developmental toxicity studies. In the prenatal developmental toxicity studies in rats and rabbits, there was no evidence of developmental toxicity at the HDT ( 35.0 mg/ kg/ day in rats and 700 mg/ kg/ day in rabbits). Decreased body weight gain was observed at the maternal LOAEL in each study; the maternal NOAEL was established at 12.5 mg/ kg/ day in rats and 100 mg/ kg/ day in rabbits. iii. Reproductive toxicity study. In the 2   generation reproduction study in rats, offspring toxicity ( body weight) and parental toxicity ( body weight, organ weight, and clinical signs) was observed at 27.0 mg/ kg/ day and greater. The parental systemic NOAEL was 7.0 mg/ kg/ day and the parental systemic LOAEL was 27.0 mg/ kg/ day. There were VerDate Jan< 31> 2003 17: 58 Jul 15, 2003 Jkt 200001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 16JYN1. SGM 16JYN1 42035 Federal Register / Vol. 68, No. 136 / Wednesday, July 16, 2003 / Notices no developmental ( pup) or reproductive effects up to 45.0 mg/ kg/ day, HDT. iv. Prenatal and postnatal sensitivity   i. Prenatal. There was no evidence of developmental toxicity in the studies at the HDT in the rat ( 70.0 mg/ kg/ day) or in the rabbit ( 700 mg/ kg/ day). Therefore, there is no evidence of a special dietary risk ( either acute or chronic) for infants and children which would require an additional safety factor. v. Postnatal. Based on the absence of pup toxicity up to dose levels which produced toxicity in the parental animals, there is no evidence of special postnatal sensitivity to infants and children in the rat reproduction study. vi. Conclusion. Based on the above, FMC Corporation concludes that reliable data support use of the standard 100 fold UF, and that an additional UF is not needed to protect the safety of infants and children. As stated above, aggregate exposure assessments utilized significantly less than 1% of the RfD for either the entire U. S. population or any of the 26 population subgroups including infants and children. Therefore, it may be concluded that there is reasonable certainty that no harm will result to infants and children from aggregate exposure to cypermethrin residues.

F. International Tolerances There are no Canadian, or Mexican residue limits, for residues of cypermethrin or zeta cypermethrin in or on pome fruits crop group or stone fruits crop group. The codex maximum residue levels for cypermethrin are 2.0 ppm for nectarine, 2.0 ppm for peaches, 1.0 for plums ( including prunes), and 2.0 ppm for pome fruits. [ FR Doc. 03   17898 Filed 7   15   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0233; FRL   7316   2]

Cis 3 hexen 1 ol; 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   0233, must be received on or before August 15, 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: Kathryn Boyle, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   6304; e mail address: boyle. kathryn@ 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. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS code 111)   Animal production ( NASICS code 112)   Food manufacturing ( NAICS code 311)   Pesticide manufacturing ( NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0233. 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 in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or VerDate Jan< 31> 2003 17: 58 Jul 15, 2003 Jkt 200001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 16JYN1. SGM 16JYN1


[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 19064-19066]
[FR Doc No: 2021-07384]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91481; File No. SR-Phlx-2021-19]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Phlx's
Pricing Schedule at Options 7, Section 8, ``Membership Fees''

April 6, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 25, 2021, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I and II below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Phlx's Pricing Schedule at Options
7, Section 8, ``Membership Fees.''
    While the changes proposed herein are effective upon filing, the
Exchange has designated the amendments become operative on April 1,
2021.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Phlx proposes to amend its pricing within Options 7, Section 8,
``Membership Fees'' to (1) waive the Inactive Nominee Fee for a six
month period; and (2) remove obsolete language. Each change is
described below.
Options 7, Section 8
    First, Phlx proposes to amend Options 7, Section 8, ``Membership
Fees,'' at Part A, ``Permit and Registration Fees,'' to waive the
Inactive Nominee \3\ Fee which is a fee of $600 for 6 months.\4\ Phlx
proposes to waive the Inactive Nominee Fee from April 1, 2021 through
September 30, 2021. The Exchange notes that the Clerk Fee \5\ of $100
per month will continue to be assessed.
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    \3\ The term ``inactive nominee'' shall mean a natural person
associated with and designated as such by a member organization and
who has been approved for such status and is registered as such with
the Membership Department. An inactive nominee shall have no rights
or privileges under a permit unless and until said inactive nominee
becomes admitted as a member of the Exchange pursuant to the By-Laws
and Rules of the Exchange. An inactive nominee merely stands ready
to exercise rights under a permit upon notice by the member
organization to the Membership Department on an expedited basis. See
Options 8, Section 2(a)(3). An Inactive Nominee shall be deemed a
Clerk pursuant to Options 8, Section 12(a). An inactive nominee's
status expires after six months unless it has been reaffirmed in
writing by the member organization or is sooner terminated. A member
organization is assessed the Inactive Nominee Fee every time the
status is reaffirmed. An inactive nominee is also assessed
Application and Initiation Fees when such person applies to be an
inactive nominee. Such fees are reassessed if there is a lapse in
their inactive nominee status. However, an inactive nominee is not
assessed Application and Initiation Fees if such inactive nominee
applied for membership without any lapse in that individual's
association with a particular member organization. An Inactive
Nominee is also assessed the Clerk Fee.
    \4\ The member organization is assessed $100 per month for the
applicable six month period unless the member organization provides
proper notice of its intent to terminate an inactive nominee prior
to the first day of the next billing month.
    \5\ The Clerk Fee is imposed on any registered on-floor person
employed by or associated with a member or member organization
pursuant to Options 3, Section 19, including Inactive Nominees
pursuant to Options 8, Section 7. The Clerk Fee is not imposed on
permit holders. See Phlx Rules at Options 7, Section 8A.
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    By way of background, on March 17, 2019 [sic],\6\ Phlx suspended
open outcry trading as a result of precautions taken with respect to
COVID-19. When the Trading Floor reopened on June 3, 2020,\7\ the
Exchange permitted each Trading Floor member organization to

be represented on the Trading Floor. However, due to the social
distancing measures that were put in place to comply with Commonwealth
of Pennsylvania health standards as well as Nasdaq's safety measures
designed to prevent the spread of COVID-19, not all members and
employees associated with a Phlx member organization were able to
return to the Trading Floor. Certain floor members have utilized
Inactive Nominees to staff the Trading Floor due to illness or other
circumstances which necessitated a change in staff.
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    \6\ See Options Trader Alert #2020--07.
    \7\ See Options Trader Alert #2020--13.
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    An Inactive Nominee allows a floor member to have additional
flexibility in obtaining coverage on the trading floor. An Inactive
Nominee stands ready to assume a membership upon notice by the member
requesting that a specific permit be transferred intra-firm on an
expedited and temporary basis. By way of example, an Inactive Nominee
would be activated in the event of an emergency due to illness or other
factors. An Inactive Nominee allows a member organization to have a
full staff available to conduct business on the Exchange trading floor
in the event of unplanned circumstances.
    At this time, with COVID-19 precautions still in place on Phlx's
trading floor, the Exchange proposes this waiver to provide floor
members with greater flexibility in registering Inactive Nominees to be
activated in the event of illness or other factors without a fee. The
Exchange believes that this waiver will enable floor members to plan
staffing more efficiently in the upcoming months, including staffing
needs during the summer, while the Trading Floor remains socially
distanced. With this waiver, member organizations may choose to
register Inactive Nominees so that they have back-ups available if they
require coverage on the Trading Floor.
    Second, Phlx proposes to remove the following obsolete rule text
from Options 7, Section 8:

    Phlx waives the Floor Lead Market Maker and Floor Market Maker
Permit Fee, for the months of July and August 2020, provided a
member or member organization (1) paid the Floor Lead Market Maker
or Floor Market Maker Permit Fee in March 2020; and (2) was not
otherwise registered as a Streaming Quote Trader or as a Remote
Streaming Quote Trader in March 2020.

The above rule text is no longer relevant as the timeframe for which
the waiver was in effect for certain fees has passed.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\8\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\9\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \10\
---------------------------------------------------------------------------

    \10\ Securities Exchange Act Release No. 51808 (June 9, 2005),
70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Likewise, in NetCoalition v. Securities and Exchange Commission
\11\ (``NetCoalition'') the D.C. Circuit upheld the Commission's use of
a market-based approach in evaluating the fairness of market data fees
against a challenge claiming that Congress mandated a cost-based
approach.\12\ As the court emphasized, the Commission ``intended in
Regulation NMS that `market forces, rather than regulatory
requirements' play a role in determining the market data . . . to be
made available to investors and at what cost.'' \13\
---------------------------------------------------------------------------

    \11\ NetCoalition v. SEC, 615 F.3d 525 (D.C. Cir. 2010).
    \12\ See NetCoalition, at 534-535.
    \13\ Id. at 537.
---------------------------------------------------------------------------

    Further, ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers'. . . .'' \14\ Although the court and
the SEC were discussing the cash equities markets, the Exchange
believes that these views apply with equal force to the options
markets.
---------------------------------------------------------------------------

    \14\ Id. at 539 (quoting Securities Exchange Act Release No.
59039 (December 2, 2008), 73 FR 74770, 74782-83 (December 9, 2008)
(SR-NYSEArca-2006-21)).
---------------------------------------------------------------------------

Options 7, Section 8
    Phlx's proposal to amend Options 7, Section 8, ``Membership Fees,''
at Part A, ``Permit and Registration Fees,'' to waive the Inactive
Nominee Fee from April 1, 2021 through September 30, 2021 is
reasonable. An Inactive Nominee allows a floor member to have
additional flexibility in obtaining coverage on the trading floor. An
Inactive Nominee stands ready to assume a membership upon notice by the
member requesting that a specific permit be transferred intra-firm on
an expedited and temporary basis. An Inactive Nominee allows a member
organization to have a full staff available to conduct business on the
Exchange trading floor in the event of unplanned circumstances. At this
time, with COVID-19 precautions still in place on Phlx's trading floor,
the Exchange proposes this waiver to provide floor members with greater
flexibility in registering Inactive Nominees to be activated in the
event of illness or other factors without a fee.
    Phlx's proposal to amend Options 7, Section 8, ``Membership Fees,''
at Part A, ``Permit and Registration Fees,'' to waive the Inactive
Nominee Fee from April 1, 2021 through September 30, 2021 is equitable
and not unfairly discriminatory. All member organizations may register
an Inactive Nominee and therefore take advantage of the fee waiver.
    The Exchange's proposal to remove obsolete rule text from Options
7, Section 8 is reasonable, equitable and not unfairly discriminatory.
The rule text is no longer relevant as the timeframe for which the
waiver was in effect for certain fees has passed.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Inter-Market Competition
    The proposal does not impose an undue burden on inter-market
competition. The Exchange believes its proposal remains competitive
with other options markets and will offer market participants with
another choice of where to transact options. The Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be

excessive, or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees to remain competitive with other exchanges. Because
competitors are free to modify their own fees in response to a
proposal, the Exchange believes that the degree to which fee changes in
this market may impose any burden on competition is extremely limited.
Intra-Market Competition
Options 7, Section 8
    Phlx's proposal to amend Options 7, Section 8, ``Membership Fees,''
at Part A, ``Permit and Registration Fees,'' to waive the Inactive
Nominee Fee from April 1, 2021 through September 30, 2021 does not
impose an undue burden on competition. All member organizations may
register an Inactive Nominee and therefore take advantage of the fee
waiver.
    The Exchange's proposal to remove obsolete rule text from Options
7, Section 8 does not impose an undue burden on competition. The rule
text is no longer relevant as the timeframe for which the waiver was in
effect for certain fees has passed.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \15\ and paragraph (f) of Rule 19b-4
thereunder.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \16\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2021-19 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2021-19. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2021-19 and should be submitted on
or before May 3, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.

[FR Doc. 2021-07384 Filed 4-9-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Page 44587]
[FR Doc No: C1-2011-17089]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-1017; FRL-8878-7]

Product Cancellation Order for Certain Pesticide Registrations

Correction

    In notice document number 2011-17089, appearing on pages 40359-
40365, in the issue of Friday, July 8, 2011, make the following
corrections:
    1. On page 40363, Table 3--Cancellations of Products Due to Non-
Payment of Maintenance Fees--Continued, column number one, ``EPA
Registration No.,'' last row, ``WA080009'' should read ``WAO70009.''
    2. On page 40364, Table 3--Cancellations of Products Due to Non-
Payment of Maintenance Fees--Continued, in the first column, ``EPA
Registration No.,'' and third row, ``WA080011'' should read
``WA070011.''

[FR Doc. C1-2011-17089 Filed 7-25-11; 8:45 am]
BILLING CODE 1505-50-D


[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Notices]
[Page 75862]
[FR Doc No: 2015-30722]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2003-0004; FRL-9937-06]

Access to Confidential Business Information by Avanti Corporation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has authorized its contractor, Avanti Corporation of
Alexandria, VA, to access information which has been submitted to EPA
under all sections of the Toxic Substances Control Act (TSCA). Some of
the information may be claimed or determined to be Confidential
Business Information (CBI).

DATES: Access to the confidential data occurred on or about November 6,
2015.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Scott Sherlock, Environmental
Assistance Division (7408M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to all who manufacture, process, or distribute
industrial chemicals. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action.

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

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2003-0004 is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. What action is the agency taking?

    Under EPA contract number GS-10F-0308P order number EP-G16H-00318,
contractor Avanti of 5520 Cherokee Avenue, Suite 205, Alexandria, VA,
will assist EPA's Office of Pollution Prevention and Toxics (OPPT) in
providing technical and administrative support for meetings related to
investigation of chemicals and biotechnology products for possible
regulatory or other control actions. They will also provide computer
database support related to providing information on chemical
regulatory actions and related policy decisions.
    In accordance with 40 CFR 2.306(j), EPA has determined that under
EPA contract number GS-10F-0308P, order number EP-G16H-00318, Avanti
will require access to CBI submitted to EPA under all sections of TSCA
to perform successfully the duties specified under the contract. Avanti
personnel will be given access to information submitted to EPA under
all sections of TSCA. Some of the information may be claimed or
determined to be CBI.
    EPA is issuing this notice to inform all submitters of information
under all sections of TSCA that EPA may provide Avanti access to these
CBI materials on a need-to-know basis only. All access to TSCA CBI
under this contract will take place at EPA Headquarters in accordance
with EPA's TSCA CBI Protection Manual.
    Access to TSCA data, including CBI, will continue until October 31,
2020. If the contract is extended, this access will also continue for
the duration of the extended contract without further notice.
    Avanti personnel will be required to sign nondisclosure agreements
and will be briefed on appropriate security procedures before they are
permitted access to TSCA CBI.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: November 20, 2105.
Pamela S. Myrick,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2015-30722 Filed 12-3-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52656-52657]
[FR Doc No: 2011-21495]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14243-000]

Lock+Hydro Friends Fund VII; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On August 4, 2011, Lock+Hydro Friends Fund VII, filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of
hydropower at the U.S. Army Corps of Engineers' (Corps) Shamokin Dam.
The Shamokin Dam Project (project) would be located on the Susquehanna
River, near the town of Shamokin Dam, in Snyder County, Pennsylvania.
The sole purpose of a preliminary permit, if issued, is to grant the
permit holder priority to file a license application during the permit
term. A preliminary permit does not authorize the permit holder to
perform any land-disturbing activities or otherwise enter upon lands or
waters owned by others without the owners' express permission.
    The proposed project would consist of the following: (1) Two
prefabricated concrete walls attached to the downstream side of the
Corps' dam which would support one frame module; (2) the frame module
would be 40 feet wide and weigh 0.65 million pounds and contain 6
generating units with a total combined capacity of 4.5 megawatts (MW);
(3) a tailrace approximately 175 feet long, lined with riprap; (4) a
new switchyard containing a transformer; and (5) a proposed 1.3-mile-
long, 34.5-kilovolt (kV) transmission line connecting to an existing
line. The proposed project would have an average annual generation of
25.64 gigawatt-hours, which would be sold to a local utility or the
Regional Independent System Operator.
    Applicant Contact: Mr. Wayne Krouse, Lock + Hydro Friends Fund VII,
5090 Richmond Avenue 390, Houston, TX 77056; phone (877) 556-
6566 x709.
    FERC Contact: Tim Looney; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.

    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14243-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: August 17, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-21495 Filed 8-22-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52444-52445]
[FR Doc No: 2016-18717]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1092]

Over-the-Counter Monograph User Fees: Reopening of Comment
Period; Stakeholder Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; reopening of comment period;
stakeholder meeting.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the
comment period for the document that announced a public meeting in the
Federal Register of May 11, 2016. In the document, FDA invited public
comment as the Agency considers a user-fee program for nonprescription
(over-the-counter or OTC) monograph drugs. FDA will hold a Webinar for
stakeholders on September 6, 2016. This Webinar is intended to be a
followup to the June 10, 2016, public meeting on this topic and to
provide stakeholders with a status update on the process of FDA and
industry discussions that began in July 2016.

DATES: Submit either electronic or written comments by October 6, 2016.
FDA will hold a Webinar for stakeholders on Tuesday, September 6, 2016,
from 10:30 a.m. to 12 p.m. EDT.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a

written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-1092 for ``Over-the-Counter Monograph User Fees: Reopening
of Comment Period; Stakeholder Meeting.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amy Bertha, Office of Executive
Programs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-1647, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is reopening until October 6, 2016, the comment period for the
document that announced a public meeting in the Federal Register of May
11, 2016 (81 FR 29275). In the document, FDA invited public comment as
the Agency considers a user-fee program for nonprescription (over-the-
counter or OTC) monograph drugs. A user-fee program would provide
funding to supplement congressional non-user-fee appropriations, and
would support timely and efficient FDA review of the efficacy and
safety of ingredients included in or proposed for inclusion in a
monograph. A public meeting on this topic was held on June 10, 2016,
and interested persons were given until July 11, 2016, to submit
comments. To ensure that all interested persons have sufficient
opportunity to share their views on a potential OTC monograph user-fee
program, FDA is reopening the comment period until October 6, 2016.
    FDA will hold a Webinar for stakeholders on September 6, 2016. This
Webinar is intended to be a followup to the June 10, 2016, public
meeting and provide stakeholders with a status update on the process of
FDA and industry discussions that began in July 2016. Meeting minutes
from these discussions can be found at: http://www.fda.gov/omuf.
Additional background information on OTC monograph drugs (such as how
OTC drugs can be marketed, the differences between marketing through
approved applications and marketing under the monographs), factors FDA
considers important in developing a user-fee program, and the questions
FDA asked the public to consider and provide input, can be found in the
Federal Register document from the June 10, 2106, public meeting
(https://www.federalregister.gov/articles/2016/05/11/2016-11098/over-the-counter-monograph-user-fees-public-meeting-request-for-comments).
The meeting transcript, meeting recording, and presentations from the
June 10, 2016, public meeting, which can serve as further background
information, can be found at: http://www.fda.gov/Drugs/NewsEvents/ucm499390.htm.

II. Stakeholder Meeting Participation

    FDA is seeking participation at the Webinar by stakeholders,
including scientific and academic experts, health care professionals,
representatives of patient and consumer advocacy groups, and
representatives of the OTC monograph industry. Participating in the
Webinar is free. The Webinar format will include presentations by FDA
staff and an opportunity for stakeholders to ask questions. If you wish
to attend the Webinar, FDA asks that you please register through
Eventbrite by Tuesday, August 30, 2016 (https://www.eventbrite.com/e/over-the-counter-monograph-user-fees-stakeholder-meeting-tickets-26751882601). FDA will email the registered attendees a URL to join the
Webinar at least 1 day before the meeting.

    Dated August 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18717 Filed 8-5-16; 8:45 am]
BILLING CODE 4164-01-P