34950 Federal Register / Vol. 68, No. 112 / Wednesday, June 11, 2003 / Notices 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   0100. 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   0100. 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   0100. 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   0100. 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. Offer alternative ways to improve the registration activity. 7. Make sure to submit your comments by the deadline in this notice. 8. 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. Registration Applications EPA received an application as follows to register a pesticide product containing a new active ingredient not included in any previously registered product pursuant to the provision of section 3( c)( 4) of FIFRA. Notice of receipt of this application does not imply a decision by the Agency on the application.

Product Containing an Active Ingredient Not Included in Any Previously Registered Product 1. File Symbol: 67979   U. Applicant: Syngenta Seeds, 3054 Cornwallis Road, Research Triangle Park, NC 27709. Product name: VIP3A. Type of product: Plant incorporated protect. Active ingredient: Bacillus thuringiensis VIP3A control protein as expressed in Event COT102 cotton plants. Proposed classification/ Use: None. For insect control on plants.

List of Subjects Environmental protection, Pesticides and pest.

Dated: May 29, 2003. Janet L. Andersen, Director, Biopesticides and Pollution Division, Office of Pesticide Programs.

[ FR Doc. 03   14326 Filed 6   10   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0194; FRL   7310   4]

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   0194, must be received on or before July 11, 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: Joanne I. Miller, Registration Division VerDate Jan< 31> 2003 23: 27 Jun 10, 2003 Jkt 200001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 11JNN1. SGM 11JNN1 34951 Federal Register / Vol. 68, No. 112 / Wednesday, June 11, 2003 / Notices ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305   6224; and e mail address: miller. joanne@ epamail. 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 categories and 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   0194. 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   0194. The system is an `` anonymous access'' system, which means EPA will not VerDate Jan< 31> 2003 23: 27 Jun 10, 2003 Jkt 200001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 11JNN1. SGM 11JNN1 34952 Federal Register / Vol. 68, No. 112 / Wednesday, June 11, 2003 / Notices 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   0194. 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   0194. 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   0194. 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. May 28, 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 BASF Corporation 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.

BASF Corporation PP 3F6568 EPA has received a pesticide petition ( PP 3F6568) from BASF Corporation, P. O. Box 13528, Research Triangle Park, NC 27709 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 part 180 by establishing a tolerance for residues of ( 3( 4,5 dihydro isoxazol 3 yl) 4 methanesulfonyl 2 methylphenyl) ( 5 hydroxyl 1 methyl 1H pyrazol 4 yl) methanone in or on the raw agricultural commodities: Corn, field, forage; corn, field, grain; corn, field, stover; corn, pop, grain; corn, pop, stover; corn, sweet, forage; corn, sweet, kernal plus cob with husks removed; corn, sweet, stover; cattle, kidney; cattle, liver; goat, kidney; goat, liver; hog, kidney; hog, liver; horse, kidney; horse, liver; sheep, kidney; and sheep, liver at 0.05; 0.01; 0.05; 0.01; 0.05; 0.05; 0.01; 0.05; 0.02; 0.70; 0.20; 0.70; 0.20; 0.70; 0.20; 0.70; 0.20; and 0.70 parts per million ( ppm), respectively. 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 BAS 670 H ( 3( 4,5 dihydro isoxazol 3 yl) 4 methanesulfonyl 2 methylphenyl)( 5 hydroxyl 1 methyl 1H pyrazol 4 yl) methanone) was determined in corn forage, stover and grain using 14C labeled materials applied to young corn plants at an exaggerated application rate of 0.134 lb active ingredient/ acre. BAS 670 H and VerDate Jan< 31> 2003 23: 27 Jun 10, 2003 Jkt 200001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 11JNN1. SGM 11JNN1 34953 Federal Register / Vol. 68, No. 112 / Wednesday, June 11, 2003 / Notices one significant metabolite, M670H05, were found in low levels in the plant matrices with the majority of the radioactive residues incorporated into natural products. M670H05 resulted from oxidation of the carbonyl bridge to a carboxylic acid with concomitant loss and breakdown of the pyrazole ring. The significant metabolite M670H05 was found in the rat metabolism study. 2. Analytical method. Suitable independently validated analytical methods ( for crop and animal matrices) are submitted for detecting and measuring BAS 670 H levels in or on food with a limit of detection that is satisfactory for enforcing the requested tolerances. Residues are first extracted from the matrices by aqueous solvent then cleaned up by acid partitioning into organic solvent, then base partitioned, and quantified with application to high performance liquid chromatography with dual mass selective detectors ( LC/ MS/ MS). 3. Magnitude of residues. Field studies were conducted at 30 sites over 2 years with sites selected to fulfill both EPA and Canadian Pest Management Regulatory Agency ( PMRA) requirements. The end product, BAS 670 00H, was applied broadcast over corn plants in two applications at 25 g active ingredient/ ha ( 0.022 lb a. i./ acre) + 75 g a. i./ ha ( 0.067 lb a. i./ acre) for a total of 100 g a. i./ ha ( 0.089 lb a. i./ acre) with the final application targeted for 45 days before milk stage. Samples of field corn were harvested at the milk stage to cover sweet corn harvest timing. All matrices were analyzed for parent and M670H05 with the limit of quantitation ( LOQ) setting the proposed tolerances. No residues were detected above the LOQ in any of the corn RAC samples analyzed ( fresh corn, forage, grain, and stover). To determine the fate of any BAS 670 residues in processed grain, the field study incorporated an exaggerated 5x application rate. No residues above LOQ were detected in the 5x treated grain samples; therefore, the analyses of the grain processed fractions was not required. The cow feeding study at three dosing levels show that food tolerances for parent in only kidney and liver matrices are necessary ( and not for any other matrices such as meat, fat, and milk).

B. Toxicological Profile 1. Acute toxicity   i. Oral ( rat): ( LD) 50 = > 2,000 milligrams/ kilogram body weight ( mg/ kg bwt) ( male/ female) = Category III. ii. Dermal ( rat): ( LD) 50 = > 2,000 mg/ kg bwt ( male/ female) = Category III. iii. Inhalation ( rat): ( LC) 50 = > 5.8 milligrams/ per liter ( mg/ L) ( male/ female) = Category IV. iv. Primary eye irritation ( rabbit): Slightly irritating = Category III. v. Primary dermal irritation ( rabbit): Slightly irritating = Category III. vi. Dermal sensitization ( guinea pig): Not a sensitizer. vii. Oral neurotoxicity ( rat): NOAEL = 2,000 mg/ kg bwt ( male/ female). 2. Genotoxicty. BAS 670 H was tested for its genotoxic potential in a battery of five in vitro or in vivo studies covering all required end points ( gene mutations, chromosomal and chromosome aberrations, and DNA damage and repair). Several batches of BAS 670 H have been tested over the time, from early laboratory produced material to current manufacturing process material. BAS 670 H did not demonstrate any genotoxic effects in vivo. In vitro, either batches tested for chromosomal aberrations caused a slight, significant clastogenic effect in the presence of S 9 mix, but the in vivo test for the equivalent end point was negative. Three of the four batches tested in the bacterial reverse mutation assay were not mutagenic, but, the batch with the least purity displayed a weak mutagenic effect at the highest dose in Salmonella typhimurium TA98 in the absence of S 9 mix, most likely caused by impurities, which are not present in the current production batch. Overall, the weight of the evidence is that BAS 670 H is not genotoxic. 3. Reproductive and developmental toxicity. The reproductive and developmental toxicity of BAS 670 H was investigated in a 2 generation rat reproduction study as well as in rat, mouse and several rabbit teratology studies ( with different batches of BAS 670 H) and a rat developmental neurotoxicity study. There were no adverse effects on fertility of both genders and no effect on the reproductive performance of males in the two generation study at any dose tested. There was, however, a high litter loss in F0 and F1 associated with insufficient maternal care at higher dose levels with clear maternal toxicity. General parental toxicity included eye and kidney effects, caused by elevated tyrosine levels due to hydroxyphenylpyruvate dioxygenase ( HPPD) inhibition. The same organs were affected in subchronic and chronic feeding studies with rats. Pup effects were observed in the F1 and F2 generation including perinatal pup mortality and impaired body weight gain, the lower body weight effects were considered to lead to brain and spleen weight changes and delays in preputial separation. As observed in the parental animals, effects on eyes and kidneys were observed in the pups. Renal pelvis dilation was observed at lower doses, although, there was no overt maternal toxicity, significantly elevated tyrosine levels were observed in the dams and pups. The no observed adverse effect level ( NOAEL) for fertility ( F0 and F1, both genders) was 4,000 ppm ( about 450 mg/ kg bwt/ day); the NOAEL for reproductive performance was 40 ppm ( about 4 mg/ kg body weight/ day) for the F1 females. The NOAEL for general toxicity was 4 ppm ( about 0.4 mg/ kg bwt/ day). The NOAEL for developmental toxicity ( growth and development of the offspring) was 4 ppm ( about 0.4 mg/ kg body weight/ day) for the F1 pups, but was lower than 4 ppm for the F2 pups due to renal pelvis dilations at all dose levels. Developmental neurotoxicity was not observed at any dose in the developmental neurotoxicity study. At all dose levels, eye effects due to elevated tyrosine levels were found in dams and pups. Additionally, there were decreased body weights in the dams at the high and mid dose, but there were no indications of adverse effects on reproductive performance of the parental females. In pups of both genders, decreased preweaning and postweaning body weight gains and body weights were observed at the low dose level and above. This is an indicator of a retardation of the general physical development, which is considered to be responsible for a slight delay of maturation. The NOAEL for developmental neurotoxicity was 800 mg/ kg bwt/ day ( highest dose tested). There is no NOAEL for the eye lesions and reduced body weight gain of the pups. NOAELs for these effects were determined in prenatal development studies in rats, rabbits and mice. No developmental toxicity was noted in the mouse prenatal development study. In the prenatal development study in rats no teratogenic effect was observed, but there was maternal toxicity together with skeletal variations in the pups. The same skeletal variation ( i. e. supernumerary ribs) was also found in rabbit prenatal development studies. This effect is associated with the family of HPPD inhibiting substances. In addition, several rabbits had pups with a soft tissue malformation: unilateral kidney agenesis. The NOAEL for the skeletal variations and the kidney agenesis was 0.5 mg/ kg bwt/ day, the NOAEL for overt maternal toxicity was 50 mg/ kg bwt/ day. The developmental effects in rabbits occurred at dose levels below overt maternal toxicity; however, measured tyrosine blood levels in the VerDate Jan< 31> 2003 23: 27 Jun 10, 2003 Jkt 200001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 11JNN1. SGM 11JNN1 34954 Federal Register / Vol. 68, No. 112 / Wednesday, June 11, 2003 / Notices dams were substantially elevated at these dose levels. Elevated tyrosine levels are known to cause kidney toxicity. 4. Subchronic toxicity. The subchronic toxicity of BAS 670 H was investigated in 90   day feeding studies in rats, mice and dogs, and in a 28   day dermal administration study in rats. Several supplemental short term mechanistic studies in rats and mice were performed to elucidate the mode of action. Generally, very mild toxicity was observed in mice and dogs at high doses. In a combined neurotoxicity 90   day feeding study in rats, no signs of neurotoxicity were observed. Effects were seen in the pancreas, eye, kidney, liver, and thyroid gland. The target organs are identical with those in the chronic feeding studies with rats. Two modes of action have been elucidated for BAS 670 H by short term mechanistic studies, one leading to effects on eyes, kidney and liver, and a second leading to effects at the thyroid: BAS 670 H causes elevated tyrosine levels by HPPD inhibition accounting for effects on eye, liver and kidney. The mouse is the accepted model for this tyrosine level elevations, and a NOAEL of 1.2 mg/ kg bwt/ day was established for tyrosine elevation in mice. Other mechanistic studies demonstrated an impairment of pituitary thyroid hormone levels by enhancing the hepatic clearance of thyroid hormones. The NOAEL for interference with thyroid hormones was 0.4 mg/ kg bwt/ day. The NOAEL for effects on the exocrine pancreas in rats was 1.1 mg/ kg/ bwt/ day. Similar effects were seen in the 28   day dermal study with rats; the NOAEL was 100 mg/ kg bwt/ day. 5. Chronic toxicity. The chronic toxicity and oncogenicity studies with BAS 670 H include two 12   month feeding studies with dogs, an 18   month mouse feeding study, a 12   month rat chronic feeding study and a 24   month rat oncogenicity study. In the chronic dog study, mild reductions of the body weight were observed at high doses. The NOAEL was 100 ppm ( 2.9 and 3.1 mg/ kg bwt/ day in males and females respectively). In the 18   month chronic feeding study in mice, increased liver weights were seen at high doses. The NOAEL was 80 ppm ( 19 and 26 mg/ kg bwt/ day in males and females respectively). BAS 670 H was not carcinogenic to mice. In the chronic feeding studies in rats, the main target organs were eye, liver, kidney, thyroid gland, and pancreas. The same organs were affected in the subchronic studies. Short term mechanistic studies demonstrated that BAS 670 H causes elevated tyrosine levels by HPPD inhibition accounting for effects on the eye, liver and kidney. The mouse is the accepted model for this tyrosine level elevation, and a NOAEL of 1.2 mg/ kg bwt/ day was established for tyrosine elevation in mice. The NOAEL for effects on the exocrine pancreas in rats 6 ppm in both genders ( 0.4 and 0.5 mg/ kg bwt/ day in males and females respectively). At the end of the 24   month oncogenicity study, there was a slight but significant increase in benign thyroid adenomas in both genders. The thyroid was the only organ affected and the increase of the adenomas was significant only at the highest dose tested, while considerable general toxicity was already seen at 20   times lower doses. The mechanism of thyroid tumor formation by BAS 670 H was thoroughly investigated in shortterm mechanistic studies. An enhanced hepatic clearance of thyroid hormones impairs pituitary thyroid hormone levels leading to hypertrophy, hyperplasia and ultimately neoplasia. There is general agreement, that this mechanism is well understood in rodents and is of minor relevance to humans. A clear NOAEL of 0.4 mg/ kg bwt/ day was demonstrated for effects on thyroid hormone levels. A threshold ( non linear) cancer assessment is proposed and a cancer classification as `` not likely to be a human carcinogen.'' 6. Animal metabolism. In the rat metabolism studies, the majority of the residue was excreted within 48 hours from both males and females. In all matrices investigated unchanged parent is the main component. Degradation starts with hydroxylation of the oxazole ring. The identified metabolites from both pyrazole ring label and phenyl ring label studies are reported. Goat and hen metabolism studies were conducted with feeding levels of about 10 ppm. In the goat, the majority of the applied dose was excreted. Non metabolized BAS 670H was the major radioactive residue, and M670H02, formed from hydroxylation at the 4 position of the isoxazole ring, was the only significant metabolite formed. In poultry BAS 670 F was also rapidly excreted. Residues in liver consisted mainly of BAS 670H, and the only significant metabolite in poultry was again M670H02. The significant metabolite M670H02 was found in the rat metabolism study. 7. Metabolite toxicology. Toxicity of the metabolites of BAS 670 H with potential exposure to humans was concurrently evaluated during toxicity testing of the parent, because both plant and animal metabolites are formed during the course of toxicity testing. Both plant and animal metabolites are considered not of toxicological concern. Some testing was conducted on the anaerobic aquatic metabolite, 670M10. The results as given below show no toxicological concern:   Bacterial reverse mutation test ( Ames): No effect = negative.   Mammalian somatic cell gene mutation test ( MNT): No effect = negative.   Cytogenetic study in vivo ( mouse HPRT): No effect = negative.   28   Day feeding study ( rat): NOAEL 1,197 mg/ kg bwt/ day and 1,304 mg/ kg bwt/ day ( male and female, respectively). 8. Endocrine disruption. BAS 670 H has been shown to alter thyroid hormone levels in rats as also observed with other 4 hydroxyphenylpyruvate dioxygenase enzyme inhibitor active ingredients. However, there have been no effects noted on sexual or other hormones in numerous subchronic and chronic toxicity studies with multiple species.

C. Aggregate Exposure 1. Dietary exposure. A chronic population adjusted dose ( cPAD) of 0.00044 mg/ kg/ day is proposed. This cPAD is based on a lowest observed adverse effect level ( LOAEL) of 0.4 mg/ kg/ day for pup renal pelvis dilation in the 2 generation rat reproduction study with an extra 3X uncertainty factor for using the LOAEL ( rather than a NOAEL) plus a 3X Food Quality Protection Act ( FQPA) factor on top of the standard 100X uncertainty factor. So the total uncertainty factor is 900 ( 3 x 3 x 100), and the cPAD is calculated as 0.4/ 900 = 0.00044. An acute dietary population adjusted dose ( aPAD) is proposed as 0.0013 mg/ kg/ day. This aPAD is based upon a NOAEL of 0.4 mg/ kg/ day obtained in the rat thyroid hormone study and a 3X FQPA uncertainty factor on top of the standard 100 ( 0.4/ 300 = 0.0013). BAS 670 H has been shown to be noncarcinogenic in mice, but was associated with an increase in thyroid follicular cell tumors at high doses in the rat. These tumors have been shown to develop by a non genotoxic mode of action, in fact they were the consequence of induced changes of thyroid hormone levels. Therefore BAS 670 H should be classified as `` not likely to be a human carcinogen.'' i. Food. Exposure estimates were compared against the cPAD and aPAD of 0.0013 mg/ kg bwt/ day and 0.004 mg/ kg bwt/ day, respectively. Results of the chronic dietary exposure assessments demonstrated that even with the worstcase assumptions ( residues at tolerance level and 100% crop treated), the estimated chronic dietary exposure was VerDate Jan< 31> 2003 23: 27 Jun 10, 2003 Jkt 200001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 11JNN1. SGM 11JNN1 34955 Federal Register / Vol. 68, No. 112 / Wednesday, June 11, 2003 / Notices less than 12.5% of the cPAD for the total U. S. population and all the subpopulations. The greatest exposure occurred in infants and children. Exposure estimates for the acute dietary assessment were well under 100% of the acute population adjusted dose ( aPAD) at the 99th percentile. The overall U. S. population and the highest exposed subpopulation ( infants < 1 year) utilized only 5.3% and less than 21%, respectively. ii. Drinking water. There are no established maximum contaminant levels or health advisory levels for residues of BAS 670 H or its metabolites in drinking water. A tier 1 drinking water modeling assessment for BAS 670 H using the FIRST model ( for surface water) and SCI GROW ( for ground water) produced estimated maximum concentrations of 0.22 parts per billion ( ppb) ( chronic) for surface water and 0.20 ppb for ground water. These estimated concentrations are less than a worst case calculated acceptable level of 3.95 ppb children chronic drinking water levels of concern ( DWLOC) for residues in drinking water based on chronic aggregate exposure. Therefore, taking into account all uses and exposures one concludes, with reasonable certainty that residues of BAS 670 H in drinking water will not result in unacceptable levels of aggregate human health risk at this time. 2. Non dietary exposure. There are no registered or proposed residential uses for BAS 670 H.

D. Cumulative Effects At this time, there is no available information to indicate that BAS 670 H or its metabolites have a common mechanism of toxicity with other substances. Therefore, there is no reason to include this pesticide or its metabolites in a cumulative risk assessment. For the purposes of this tolerance action, EPA has not assumed that BAS 670 H and its metabolites have a common mechanism of toxicity with other substances.

E. Safety Determination 1. U. S. population. Aggregate exposure to the overall U. S. population utilized only 8.7% of the aPAD and 12.7% of the cPAD, respectively. Therefore, no harm to the overall U. S. population would result from the use of BAS 670 H on field, sweet, or pop corn. 2. Infants and children. There is a complete toxicity base for BAS 670 H and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Taking into account the completeness of the data base, BASF Corporation concludes that the FQPA safety factor should be retained but reduced to 3X. This is based on the occurrence of kidney malformations in rabbits and skeletal variations in rabbits and rats, all occurring at doses, which caused either maternal tyrosine elevations or other evidence of maternal toxicity. The full toxicological data base that has been developed for BAS 670 H includes many additional mechanistic studies, revealing consistency and the mode of action of these effects. The kidney was a target organ in all repeated dose studies and these effects were caused by elevated tyrosine levels due to inhibition of the HPPD enzyme. Using the standard worst case exposure assumptions ( residues at tolerance level and 100% crop treated), aggregate exposure to BAS 670 H from food and water will utilize 33% and less than 24% of the aPAD and cPAD, respectively for infants and children. EPA generally has no concern for exposures below 100% of the PAD because it represents the level at or below which daily aggregate exposure over a lifetime will not pose appreciable risks to human health. BASF Corporation concludes that there is a reasonable certainty that no harm will result to infants or children from aggregate exposure to BAS 670 H residues with the approval of this tolerance petition.

F. International Tolerances No maximum residue levels ( MRLs) have been established for BAS 670 H by the CODEX Alimentarius Commission or in Mexico. [ FR Doc. 03   14328 Filed 6   10   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0177; FRL   7308   7]

Acetic Acid; Notice of Filing a Pesticide Petition to Establish an Exemption from the Requirements of 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   0177, must be received on or before July 11, 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: Driss Benmhend, Biopesticides and Pollution Prevention Division ( 7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   9525; e mail address: benmhend. driss@ 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 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   0177. 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 VerDate Jan< 31> 2003 23: 27 Jun 10, 2003 Jkt 200001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 11JNN1. SGM 11JNN1


[Federal Register Volume 86, Number 45 (Wednesday, March 10, 2021)]
[Proposed Rules]
[Pages 13668-13670]
[FR Doc No: 2021-04873]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0152; Airspace Docket No. 21-AGL-2]
RIN 2120-AA66

Proposed Amendment of Jet Routes J-107 and J-515, and VOR Federal
Airway V-181; Establishment of Area Navigation (RNAV) Route T-407; and
Revocation of the Humboldt, MN, Domestic Low Altitude Reporting Point;
Northcentral United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to amend two Jet Routes and one VHF
Omnidirectional Range (VOR) Federal Airway; establish one low altitude
RNAV route; and revoke one Domestic Low Altitude Reporting Point, in
the northcentral United States. This action is necessary due to the
planned decommissioning of the VOR portion of the Humboldt, MN, VOR/
Tactical Air Navigation (VORTAC) which provides navigation guidance to
portions of the affected Air Traffic Service (ATS) routes. The Humboldt
VOR is being decommissioned as part of the FAA's VOR Minimum
Operational Network (VOR MON) program.

DATES: Comments must be received on or before April 26, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2021-0152; Airspace Docket No. 21-AGL-2 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jesse Acevedo, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would expand the availability of RNAV in the central
United States and improve the efficient flow of air traffic within the
NAS by lessening the dependency on ground-based navigation.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2021-0152; Airspace Docket No. 21-AGL-2) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2021-0152; Airspace Docket No. 21-AGL-2.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Operations Support Group, Central
Service Center, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020 and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

Background

    The FAA is planning decommissioning activities for the VOR portion
of Humboldt VORTAC with a proposed effected date of December 2, 2021.
The Humboldt VOR was one of the candidate VORs identified for
discontinuance by the FAA's VOR MON program and listed in the Final
policy statement notice, ``Provision of Navigation Services for the
NextGen Transition to Performance-Based Navigation (PBN) (Plan for
Establishing a VOR MON),'' published in the Federal Register of July
26, 2016 (81 FR 48694),

Docket No. FAA-2011-1082. Although the VOR portion of the Humboldt
VORTAC is planned for decommissioning, the co-located Distance
Measuring Equipment (DME) and Tactical Air Navigation (TACAN) portions
of the navigational aid are being retained in support of current and
future RNAV procedures and Department of Defense mission requirements.
    The ATS routes affected by the Humboldt VOR are J-107, J-515, and
V-181. With the planned decommissioning of the Humboldt VOR, the
remaining ground-based navigational aid coverage in the area is
insufficient to enable the continuity of these affected routes. As a
result, proposed modifications to J-107, J-515, and V-181 would result
in airway segments being removed. To overcome the loss of route
segments in the ATS routes, instrument flight rules (IFR) traffic may
use adjacent Jet Routes, J-36, J-140, J-562, and J-89. Pilots equipped
with RNAV capabilities may also file point to point through the
affected area using fixes that will remain in place, or receive air
traffic control radar vectors; the pilots could also use RNAV Route, Q-
140, to navigate through or around the affected area. Visual flight
rules (VFR) pilots who elect to navigate through the affected area may
utilize the ATC services previously listed.
    Additionally, the proposed new T-route would provide an enroute
structure that would overlap the VOR Federal airway V-181 for RNAV
capable aircraft. This new T-route proposal would also provide route
options in areas of limited or no radar coverage to pilots whose
aircraft are RNAV capable. The new airway will provide positive course
guidance to aircraft navigating around areas of heavy aviation activity
(i.e., Grand Forks) and Military Special Use Airspace (i.e., Tiger
South MOA, Devils Lake East MOA, and Restricted Areas R-5403A/B/C/D/E/
F). Furthermore, this proposed new airway would also support the FAA's
plan to transition the National Airspace System from a ground-based
surveillance and navigation system, to a satellite-based system.
    Finally, FAA is proposing to remove the Humboldt, MN Domestic Low
Altitude Reporting point. The reporting point is no longer required by
air traffic control after the proposed route amendments would be
implemented.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to amend two
Jet Routes; amend one VOR Federal Airway; establish one RNAV route; and
revoke one reporting point. The proposed ATS route and reporting point
amendments are described below.
    J-107: J-107 extends between Los Angeles, CA, VORTAC and Sioux
Narrows, ON, Canada, VOR/DME. The portion within Canada is excluded.
The proposed change would remove the route segments between Dupree, SD,
VOR/DME, and Sioux Narrows, ON, Canada, VOR/DME, and remove the
exclusionary language. The resulting Jet Route would extend between Los
Angeles, CA, VORTAC and Dupree, SD, VOR/DME.
    J-515: J-515 extends between Fargo, ND, VOR/DME and the
intersection of the Humboldt, MN, VORTAC 356[deg] radial and US/Canada
border; and between Whitehorse, YT, Canada and the Barrow, AK, VOR/DME.
The airspace within Canada is excluded. The proposed change would
remove the route segment between the Fargo, ND, VOR/DME and the
intersection of the Humboldt, MN, VORTAC 356[deg] radial and US/Canada
border. As a result, the Jet Route would extend between Whitehorse, YT,
Canada, VOR/DME and Barrow, AK, VOR/DME.
    V-181: V-181 extends between Kirksville, MO, VORTAC, and the
intersection of the Humboldt, MN, VORTAC, 356[deg] radial and United
States/Canada border. The proposed change would remove the route
segment between the Grand Forks, ND, VOR/DME and the intersection of
the Humboldt, MN, VORTAC, 356[deg] radial and United States/Canada
border. As a result, the airway would extend between the Kirksville,
MO, VORTAC, and the Grand Forks, ND, VOR/DME.
    T-407: T-407 would be a new RNAV route that extends between the
Sioux Falls, SD, VORTAC and the ZOMTA fix, located at the US/Canadian
border, 8 miles north of Humboldt, MN, VORTAC. This T-route would
provide enroute routing over the current VOR Federal airway V-181 from
Sioux Falls, SD, VORTAC north to the United States/Canadian border.
    Humboldt: The Humboldt MN Domestic Low Altitude Reporting Point
would be removed.
    All of the navigational aid radials in the Jet Route descriptions
below are stated in True degrees.
    United States Jet Routes, VOR Federal airways, RNAV T-routes, and
Domestic Low Altitude Reporting points are published in paragraphs
2004, 2010(a), 6011, and 7001, respectively, of FAA Order 7400.11E,
dated July 21, 2020, and effective September 15, 2020, which are
incorporated by reference in 14 CFR 71.1. The airways listed in this
document would be subsequently updated in the next edition of this
Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 2004 Jet Routes.

* * * * *

J-107 [Amended]

    From Los Angeles, CA; INT Los Angeles 083[deg] and Hector, CA,
226[deg] radials; Hector; Boulder City, NV; Milford, UT; Rock
Springs, WY; Muddy Mountain, WY; to Dupree, SD.
* * * * *

J-515 [Amended]

    From Whitehorse, YT, Canada; Northway, AK; Fairbanks, AK;
Bettles, AK; to Barrow, AK. The airspace within Canada is excluded.
* * * * *

Paragraph 6010(a) VOR Federal Airways.

* * * * *

V-181 [Amended]

    From Kirksville, MO; Lamoni, IA; Omaha, IA; Norfolk, NE;
Yankton, SD; Sioux Falls, SD; Watertown, SD; 34 miles, 24 miles, 34
MSL, Fargo, ND; to Grand Forks, ND.
* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-407 Sioux Falls, SD (FSD) to ZOMTA, ND [New]

Sioux Falls, SD (FSD)                           VORTAC                         (Lat. 43[deg]38'58.14'' N, long. 096[deg]46'52.02'' W)
FFORT, SD                                       WP                             (Lat. 44[deg]58'47.45'' N, long. 097[deg]08'30.36'' W)
Fargo, ND (FAR)                                 VOR/DME                        (Lat. 46[deg]45'12.01'' N, long. 096[deg]51'04.75'' W)
Grand Forks, ND (GFK)                           VOR/DME                        (Lat. 47[deg]57'17.40'' N, long. 097[deg]11'07.33'' W)
WUBED, MN                                       FIX                            (Lat. 48[deg]43'30.50'' N, long. 097[deg]07'40.81'' W)
ZOMTA, ND                                       FIX                            (Lat. 49[deg]00'00.00'' N, long. 097[deg]07'54.80'' W)

Paragraph 7001 Domestic Low Altitude Reporting Points.

* * * * *

Humboldt, MN [Removed]

* * * * *

    Issued in Washington, DC, on March 2, 2021.
George Gonzalez,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2021-04873 Filed 3-9-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Rules and Regulations]
[Pages 44309-44312]
[FR Doc No: 2017-19654]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0511; Product Identifier 2016-NM-176-AD; Amendment
39-19036; AD 2017-19-06]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc. Model CL-600-1A11 (CL-600), CL-600-2A12 (CL-601
Variant), and CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants)
airplanes. This AD was prompted by a new life limitation that has been
introduced for the side brace fitting shaft and side brace-to-airplane
fitting pin of the main landing gear (MLG). This AD requires revising
the maintenance or inspection program. This AD also requires an
inspection to identify the serial number, to serialize, and to record
the accumulated life of the side brace fitting shaft of the MLG. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective October 27, 2017.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of October 27,
2017.

ADDRESSES: For service information identified in this final rule,
contact Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; Widebody Customer Response Center North
America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-
514-855-2999; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Internet http://www.bombardier.com. You may view this referenced
service information at the FAA, Transport Standards Branch, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2017-0511.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0511; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
800-647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Aziz Ahmed, Aerospace Engineer,
Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.
Model CL-600-1A11 (CL-600), CL-600-2A12 (CL-601 Variant), and CL-600-
2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) airplanes. The NPRM
published in the Federal Register on June 7, 2017 (82 FR 26403) (``the
NPRM'').
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2016-17R2, dated June 29, 2016 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the

MCAI''), to correct an unsafe condition for certain Bombardier, Inc.,
Model CL-600-1A11 (CL-600), CL-600-2A12 (CL-601 Variant), and CL-600-
2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) airplanes. The MCAI
states:

    Based on in-service experience, a new life limitation has been
introduced for the following side brace fitting shaft part numbers:
     600-10237-1/-5
     600-10237-3
     601R10237-1/-3
    In order to facilitate identification and tracking, the
component must be identified and serialized. Bombardier has revised
the Time Limits/Maintenance Checks (TLMC) Manual to include new life
limits and issued Service Bulletins (SB) for serialization of the
affected parts.
    The original version of this [Canadian] AD was issued to mandate
the incorporation of the new TLMC life limits as well as
identification and serialization of the affected parts. The revision
1 of this [Canadian] AD was issued * * * June [10,] 2016 to correct
a typographic error in Table A of the Corrective Actions section.
The revision 2 of this [Canadian] AD is being issued to correct/
update the TLMC data in Table A of the Corrective Actions section.

    Required actions include an inspection to identify the serial
number, to serialize, and to record the accumulated life of the side
brace fitting shaft of the MLG. The unsafe condition is the loss of
structural integrity of the affected part. You may examine the MCAI in
the AD docket on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2017-0511.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    We have reviewed the following service information. This service
information describes the life limits for the side brace fitting shaft
and side brace-to-airplane fitting pin of the MLG. This service
information is distinct since it applies to different airplane models
in different configurations.
     Section 5-10-10, Time Limits (Structural), of the
Airworthiness Limitations, of the Bombardier Challenger 600 Time
Limits/Maintenance Checks Manual, Publication No. PSP 605, Revision 37,
dated April 29, 2016.
     Section 5-10-10, Time Limits (Structural)--Pre SB 601-
0280, of the Airworthiness Limitations, of the Bombardier Challenger
601 Time Limits/Maintenance Checks Manual, Publication No. PSP 601-5,
Revision 42, dated April 22, 2014.
     Section 5-10-10, Time Limits (Structural), of the
Airworthiness Limitations, of the Bombardier Challenger 601 Time
Limits/Maintenance Checks Manual, Publication No. PSP 601A-5, Revision
38, dated April 22, 2014.
     Section 5-10-10, Life Limits (Structures), of Part 2,
Airworthiness Limitations, of the Bombardier Challenger CL-604 Time
Limits/Maintenance Checks Manual, Publication No. CH 604 TLMC, Revision
26, dated June 9, 2016.
     Section 5-10-10, Life Limits (Structures) to Part 2,
Airworthiness Limitations, of the Bombardier Challenger CL-605 Time
Limits/Maintenance Checks Manual, Publication No. CH 605 TLMC, Revision
14, dated June 9, 2016.
    We have also reviewed the following service information. This
service information describes procedures for an inspection to identify
the serial number, to serialize, and to record the accumulated life of
the side brace fitting shaft of the MLG. The service bulletins are
distinct since they apply to different airplane models.
     Bombardier Service Bulletin 600-0768, dated September 9,
2014.
     Bombardier Service Bulletin 601-0636, Revision 01, dated
May 10, 2016.
     Bombardier Service Bulletin 604-57-005, dated September 9,
2014.
     Bombardier Service Bulletin 605-57-003, dated September 9,
2014.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 133 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Maintenance or inspection program       1 work-hour x $85 per                 $0             $85         $11,305
 revision.                               hour = $85.
Inspection, identification,             1 work-hour x $85 per                 33             118          15,694
 serialization, and recording.           hour = $85.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2017-19-06 Bombardier, Inc.: Amendment 39-19036; Docket No. FAA-
2017-0511; Product Identifier 2016-NM-176-AD.

(a) Effective Date

    This AD is effective October 27, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes specified in paragraphs (c)(1)
through (c)(3) of this AD, certificated in any category.
    (1) Bombardier, Inc. Model CL-600-1A11 (CL-600) airplanes,
serial numbers 1004 through 1085 inclusive.
    (2) Bombardier, Inc. Model CL-600-2A12 (CL-601 Variant)
airplanes, serial numbers 3001 through 3066 inclusive.
    (3) Bombardier, Inc. Model CL-600-2B16 (CL-601-3A, CL-601-3R,
and CL-604 Variants) airplanes, serial numbers 5001 through 5194
inclusive; serial numbers 5301 through 5665 inclusive, and serial
numbers 5701 through 5851 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by a new life limitation that has been
introduced for the side brace fitting shaft and side brace-to-
airplane fitting pin of the main landing gear (MLG). We are issuing
this AD to prevent the loss of structural integrity of the affected
part.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Revision of Maintenance or Inspection Program

    Within 30 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, by incorporating
the life limits for the side brace fitting shaft and side brace-to-
airplane fitting pin of the MLG, as applicable, identified in table
1 to paragraph (g) of this AD. The initial compliance time for
accomplishing the replacement is at the applicable time in the
Bombardier Time Limits/Maintenance Checks (TLMC) Manual revisions
specified in table 1 to paragraph (g) of this AD, or within 30 days
after the effective date of this AD, whichever occurs later.

                                         Table 1 to Paragraph (g) of This AD--Life Limits for the Affected Parts
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Airplane model (serial Nos. (S/                                             TLMC manual                                Revision
               Ns))                      Part name           Part No.            No.                 Section              No.          Revision date
--------------------------------------------------------------------------------------------------------------------------------------------------------
CL-600-1A11 (S/Ns 1004 through     MLG Side Brace-to-    600-10237[dash]1/        PSP 605  5-10-10...................         37  April 29, 2016.
 1085 inclusive).                   Airplane Fitting                   -5
                                    Pin.
CL-600-2A12 (S/N 3001-3066         MLG Side Brace-to-         600-10237-3       PSP 601-5  5-10-10...................         42  April 22, 2014.
 inclusive).                        Airplane Fitting
                                    Pin.
CL-600-2B16 (S/Ns 5001-5194        MLG Side Brace-to-         600-10237-3      PSP 601A-5  5-10-10...................         38  April 22, 2014.
 inclusive).                        Airplane Fitting
                                    Pin.
CL-600-2B16 (S/Ns 5301-5665        MLG Side Brace          601R10237-1/-3          CL-604  5-10-10 (Part 2)..........         26  June 9, 2016.
 inclusive).                        Fitting Shaft.
CL-600-2B16 (S/Ns 5701-5851        MLG Side Brace          601R10237-1/-3          CL-605  5-10-10 (Part 2)..........         14  June 9, 2016.
 inclusive).                        Fitting Shaft.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(h) Inspection, Serialization, and Recording of Life Limited Parts

    Within 48 months after the effective date of this AD: Inspect to
identify the serial number, serialize, and record the accumulated
life of the side brace fitting shaft of the MLG, as applicable, in
accordance with the Accomplishment Instructions of the applicable
service information identified in paragraphs (h)(1) through (h)(4)
of this AD.
    (1) For CL-600-1A11 airplanes (S/Ns 1004 through 1085
inclusive): Bombardier Service Bulletin 600-0768, dated September 9,
2014.
    (2) For CL-600-2A12 (S/Ns 3001 through 3066 inclusive) and CL-
600-2B16 airplanes (S/Ns 5001 through 5194 inclusive): Bombardier
Service Bulletin 601-0636, Revision 01, dated May 10, 2016.
    (3) For CL-600-2B16 airplanes (S/Ns 5301 through 5665
inclusive): Bombardier Service Bulletin 604-57-005, dated September
9, 2014.
    (4) For CL-600-2B16 airplanes (S/Ns 5701 through 5851
inclusive): Bombardier Service Bulletin 605-57-003, dated September
9, 2014.

(i) No Reporting Requirement

    Although the service information identified in paragraphs (h)(1)
through (h)(4) of this AD specifies to submit certain information to
the manufacturer, this AD does not include that requirement.

(j) No Alternative Actions and Intervals

    After the maintenance or inspection program has been revised, as
applicable, as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) or intervals may be used unless the
actions or intervals are approved as an alternative method of
compliance (AMOC) in accordance with the procedures specified in
paragraph (k)(1) of this AD.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs)

    The Manager, New York ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending

information directly to the manager of the certification office,
send it to ATTN: Program Manager, Continuing Operational Safety,
FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.

(2) Contacting the Manufacturer

    For any requirement in this AD to obtain corrective actions from
a manufacturer, the action must be accomplished using a method
approved by the Manager, New York ACO Branch, FAA; or Transport
Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design
Approval Organization (DAO). If approved by the DAO, the approval
must include the DAO-authorized signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2016-17R2, dated June 29,
2016, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0511.
    (2) For more information about this AD, contact Aziz Ahmed,
Aerospace Engineer, Airframe and Mechanical Systems Section, FAA,
New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Section 5-10-10, Time Limits (Structural), of the
Airworthiness Limitations, of the Bombardier Challenger 600 Time
Limits/Maintenance Checks Manual, Publication No. PSP 605, Revision
37, dated April 29, 2016. The revision level is only identified in
the Record of Revisions.
    (ii) Section 5-10-10, Time Limits (Structural)--Pre SB 601-0280,
of the Airworthiness Limitations, of the Bombardier Challenger 601
Time Limits/Maintenance Checks Manual, Publication No. PSP 601-5,
Revision 42, dated April 22, 2014. The revision level is only
identified in the Record of Revisions.
    (iii) Section 5-10-10, Time Limits (Structural), of the
Airworthiness Limitations, of the Bombardier Challenger 601 Time
Limits/Maintenance Checks Manual, Publication No. PSP 601A-5,
Revision 38, dated April 22, 2014. The revision level is only
identified in the Record of Revisions.
    (iv) Section 5-10-10, Life Limits (Structures), of Part 2,
Airworthiness Limitations, of the Bombardier Challenger CL-604 Time
Limits/Maintenance Checks Manual, Publication No. CH 604 TLMC,
Revision 26, dated June 9, 2016. The revision level is only
identified in the Record of Revisions.
    (v) Section 5-10-10, Life Limits (Structures) to Part 2,
Airworthiness Limitations, of the Bombardier Challenger CL-605 Time
Limits/Maintenance Checks Manual, Publication No. CH 605 TLMC,
Revision 14, dated June 9, 2016. The revision level is only
identified in the Record of Revisions.
    (vi) Bombardier Service Bulletin 600-0768, dated September 9,
2014.
    (vii) Bombardier Service Bulletin 601-0636, Revision 01, dated
May 10, 2016.
    (viii) Bombardier Service Bulletin 604-57-005, dated September
9, 2014.
    (ix) Bombardier Service Bulletin 605-57-003, dated September 9,
2014.
    (3) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; Widebody Customer Response Center
North America toll-free telephone 1-866-538-1247 or direct-dial
telephone 1-514-855-2999; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on September 7, 2017.
Jeffrey E, Duven,
Director, System Oversight Division, Aircraft Certification Service.
[FR Doc. 2017-19654 Filed 9-21-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80869-80870]
[FR Doc No: 2010-32222]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63562; File No. SR-Phlx-2010-177]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NASDAQ OMX PHLX, Inc. Relating
to Options Overlying QNET

December 16, 2010.
    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 December 15, 2010, NASDAQ OMX PHLX, Inc. (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III, 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's Fee Schedule for
Sector Index Options to expand the promotional pricing period for
options overlying the NASDAQ Internet Index (``QNET'').
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqtrader.com/micro.aspx?id=PHLXfilings, 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
    The Exchange previously filed a rule change to add additional
transaction fees to Category III of its Fee Schedule, titled Sector
Index Options, for options overlying QNET from trade date April 30,
2010 through trade date December 30, 2010.\3\ The purpose of the
promotional pricing is to assess a fixed rate across all market
participants for a specified period of time to incentivize members to
trade QNET.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 61984 (April 26,
2010), 75 FR 23313 (May 3, 2010) (SR-Phlx-2010-60).
---------------------------------------------------------------------------

    The Exchange currently assesses a $.20 per contract transaction fee
for options overlying QNET for the following market participants:
Customers, registered options traders (on-floor), specialists,
professionals,\4\ firms and broker-dealers. Pursuant to the rule
change, on December 31, 2010, the Exchange will assess the options
transaction charges for sector index options as designated by category
of market participant on the Fee Schedule.\5\
---------------------------------------------------------------------------

    \4\ The Exchange defines a ``professional'' as any person or
entity that (i) is not a broker or dealer in securities, and (ii)
places more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s).
    \5\ See footnote 3. The Exchange's filing eliminates the $.20
per contract transaction promotional pricing after December 30,
2010, and instead assesses members the applicable sector index
options transaction charges, by market participant, starting on
December 31, 2010. For example, for transactions in QNET sector
index options, a customer would no longer be assessed the $.20 per
contract on trade date December 31, 2010, but instead would be
assessed the option transaction charge, which is currently $.44 per
contract.
---------------------------------------------------------------------------

    The Exchange is proposing to expand the promotional pricing to
trade date December 31, 2010. This proposal would eliminate the $.20
per contract transaction promotional pricing after December 31, 2010,
and would instead cause members to be assessed the applicable sector
index options transaction charges, by market participant, starting on
January 3, 2011 (the next trade date). For example, for transactions in
QNET sector index options, a customer would no longer be assessed $.20
per contract on trade date January 3, 2011, but instead would be
assessed the option transaction charge, which is currently $.44 per
contract.
    The Exchange recently filed a proposal to amend its calculation of
transaction fees for billing purposes from settlement date to trade
date billing.\6\ In that filing, the Exchange amended the billing cycle
so that a member who receives an invoice for the month of December 2010
will be assessed fees from November 30, 2010 (trade date) through
December 31, 2010 (trade date) instead of through December 30, 2010
(trade date).\7\ The Exchange is proposing to amend the QNET
promotional pricing to allow members to obtain the promotional pricing
through the end of the December billing period. The Exchange also
proposes amending the Fee Schedule to reflect this amendment of the
date for the QNET promotional period.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 63406 (December 1,
2010), 75 FR 76511 (December 8, 2010) (SR-Phlx-2010-165).
    \7\ See footnote 6.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \8\ in general, and furthers
the objectives of Section 6(b)(4) of the Act \9\ in particular, in that
it is an equitable allocation of reasonable fees and other charges
among Exchange members. The Exchange believes that expanding the
promotional pricing for sector index option fees for QNET is equitable
because all market participants would be able to obtain the promotional
pricing for the extra day. The Exchange further believes that offering
the $.20 per contract fee for a specified promotional period and
thereafter assessing the standard sector index option transaction fees
is also equitable because it is intended to encourage trading in QNET.
---------------------------------------------------------------------------

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

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.

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 \10\ and

paragraph (f)(2) of Rule 19b-4 \11\ thereunder. 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 necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \11\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2010-177 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2010-177. This file
number should be included on the subject line if e-mail 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 Web site (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 Web site viewing and
printing in the Commission's Public Reference Room. 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; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-Phlx-2010-177 and should be submitted on or before
January 13, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-32222 Filed 12-22-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 232 (Tuesday, December 3, 2013)]
[Proposed Rules]
[Pages 72611-72612]
[FR Doc No: 2013-28964]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R05-OAR-2013-0678; FRL-9903-34-Region 5]

Proposal for Hospital/Medical/Infectious Waste Incinerator
Negative Declaration for Designated Facilities and Pollutants: Michigan
and Wisconsin

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is notifying the public that we have received from
Michigan and Wisconsin negative declarations for Hospital/Medical/
Infectious Waste Incinerators (HMIWI). The Michigan Department of
Environmental Quality submitted on August 9, 2013 a negative
declaration certifying that there are no HMIWI units currently
operating in the

state of Michigan. The Wisconsin Department of Natural Resources
submitted on July 15, 2013 a negative declaration certifying that there
are no HMIWI units currently operating in the state of Wisconsin.

DATES: Comments must be received on or before January 2, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2013-0678, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Carlton T. Nash, Chief, Toxics and Global Atmosphere
Section, Air Toxics and Assessment Branch (AT-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Carlton T. Nash, Chief, Toxics and Global
Atmosphere Section, Air Toxics and Assessment Branch (AT-18J), U.S.
Environmental Protection Agency, 77 West Jackson Boulevard, Chicago,
Illinois 60604. Such deliveries are only accepted during the Regional
Office normal hours of operation, and special arrangements should be
made for deliveries of boxed information. The Regional Office official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.
excluding Federal holidays.

Please see the direct final rule which is located in the Rules section
of this Federal Register for detailed instructions on how to submit
comments.

FOR FURTHER INFORMATION CONTACT: Margaret Sieffert, Environmental
Engineer, Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard (AT-18J), Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Rules section of this Federal
Register, EPA is amending 40 CFR part 62 to reflect the States'
submittals of the negative declarations as a direct final rule without
prior proposal because the Agency views this as a noncontroversial
action and anticipates no adverse comments. A detailed rationale for
the action is set forth in the direct final rule. If no adverse
comments are received in response to this rule, no further activity is
contemplated. If EPA receives adverse comments, we will withdraw the
direct final rule and will address all public comments in a subsequent
final rule based on this proposed rule. EPA will not institute a second
comment period. Any parties interested in commenting on this action
should do so at this time. Please note that if EPA receives adverse
comment on any part of this rule, and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: November 8, 2013.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2013-28964 Filed 12-2-13; 8:45 am]
BILLING CODE 6560-50-P