11093 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Notices F. International Tolerances There are no established codex, Canadian or Mexican maximum residue levels for spiroxamine. [ FR Doc. 03   5316 Filed 3   6   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0025; FRL   7289   8]

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

SUMMARY: This notice announces the initial filing of pesticide petitions 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   0025, must be received on or before April 7, 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: Shaja R. Brothers, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   3194; e mail address: brothers. shaja@ 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 producers ( 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions. 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   0025. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information CBI or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or 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 VerDate Dec< 13> 2002 17: 55 Mar 06, 2003 Jkt 200001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 07MRN1. SGM 07MRN1 11094 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Notices 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   0025. 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   0025. 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   0025. 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   0025. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

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

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

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

II. What Action is the Agency Taking?

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

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

Dated: January 30, 2003. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions The petitioner summaries of the pesticide petitions are printed below as required by FFDCA section 408( d)( 3). The summaries of the petitions were prepared by the petitioners and represent the views of the petitioners. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Interregional Research Project Number IR 4 2E6416, 2E6425, 2E6428, and 2E6436 EPA has received pesticide petitions ( 2E6416, 2E6425, 2E6428, and 2E6436) from the Interregional Research Project Number IR 4, 681 U. S. Highway # 1 South, North Brunswick, NJ 08902 VerDate Dec< 13> 2002 17: 55 Mar 06, 2003 Jkt 200001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 07MRN1. SGM 07MRN1 11095 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Notices proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR 180.510 by establishing tolerances for residues of pyriproxyfen, 2[ 1 methyl 2 4 phenoxyphenoxy) ethoxypyridine] in or on the following raw agricultural commodities: 1. PP 2E6416 proposes the establishment of tolerances for atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar apple at 0.20 parts per million ppm ( ppm). 2. PP 2E6425 proposes the establishment of tolerances for fig at 0.30 ppm, and fig, dried at .1 ppm. 3. PP 2E6428 proposes the establishment of tolerances for avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and star apple at 1.0 ppm. 4. PP 2E6436 proposes the establishment of a tolerance for okra at 0.02 ppm. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petitions. Additional data may be needed before EPA rules on the petitions. This notice includes a summary of the petitions prepared by Valent USA Corporation.

A. Residue Chemistry 1. Plant metabolism. The major metabolic pathways in plants is aryl hydroxylation and cleavage of the ether linkage, followed by further metabolism into more polar products by further oxidation and/ or conjugation reactions. However, the bulk of the radiochemical residue on raw agricultural commodities samples remained as parent. Comparing metabolites detected and quantified from cotton, apple, tomato, goat, hen, and rat shows that there are no significant aglycones in plants which are not also present in the excreta or tissues of animals. The residue of concern is best defined as the parent, pyriproxyfen. 2. Analytical method. The extraction methodology has been validated using aged radiochemical residue samples from metabolism studies. The methods have been validated in cottonseed, apples, soil, and oranges at independent laboratories. EPA has successfully validated the analytical methods for analysis of cottonseed, pome fruit, nutmeats, almond hulls, and fruiting vegetables. The limit of detection of pyriproxyfen in the methods is 0.01 ppm which will allow monitoring of food with residues at the levels proposed for the tolerances. 3. Magnitude of residues. The magnitude of residues for pyriproxyfen is adequately understood for the proposed commodities.

B. Toxicological Profile 1. Acute toxicity. An assessment of toxic effects caused by pyriproxyfen is discussed in Unit II. B. of the Federal Register dated April 4, 2001 ( FRL   6772   4) ( 66 FR 17883). 2. Animal metabolism. The absorption, tissue distribution, metabolism and excretion of 14C labeled pyriproxyfen were studied in rats after single oral doses of 2 or 1,000 milligrams/ kilograms body weight ( mg/ kg/ bwt) ( phenoxyphenyl and pyridyl label), and after a single oral dose of 2 mg/ kg/ bwt, phenoxyphenyl label only, following 14 daily oral doses at 2 mg/ kg/ bwt of unlabelled material. For all dose groups, most 88   96%) of the administered radiolabel was excreted in the urine and feces within 2 days after radiolabeled test material dosing, and 92   98% of the administered dose was excreted within 7 days. Seven days after dosing, tissue residues were generally low, accounting for no more than 0.3% of the dosed 14C. Radiocarbon concentrations in fat were the higher than in other tissues analyzed. Recovery in tissues over time indicates that the potential for bioaccumulation is minimal. There were no significant sex or dose related differences in excretion or metabolism. 3. Metabolite toxicology. The potential for chronic toxicity is adequately tested by chronic exposure to the parent at the maximum tolerated dose and consequent chronic exposure to the internally formed metabolites. Seven metabolites of pyriproxyfen, 4  OHpyriproxyfen 5  OH pyriproxyfen, desphenyl pyriproxyfen, POPA, PYPAC, 2 OH pyridine and 2,5 diOH pyridine, have been tested for mutagenicity, via Ames assay, and acute oral toxicity to mice. All seven metabolites were tested in the Ames assay with and without S9 at doses up to 5,000 micrograms per plate or up to the growth inhibitory dose. The metabolites did not induce any significant increases in revertible colonies in any of the test strains. Positive control chemicals showed marked increases in reverting colonies. The acute toxicity to mice of 4  OHpyriproxyfen 5  OH pyriproxyfen, desphenyl pyriproxyfen, POPA, and PYPAC did not appear to markedly differ from pyriproxyfen, with all metabolites having acute oral lethal dose ( LD50) values greater than 2,000 mg/ kg/ bwt. The two pyridines, 2 OHpyridine and 2,5 diOH pyridine, gave acute oral LD50 values of 124 ( male) and 166 ( female) mg/ kg/ bwt, and 1,105 ( male) and 1,000 ( female) mg/ kg/ bwt, respectively. 4. Endocrine disruption. While specific tests, uniquely designed to evaluate the potential effects of pyriproxyfen on mammalian endocrine systems have not been conducted, the toxicology of pyriproxyfen has been extensively evaluated in acute, subchronic chronic, developmental, and reproductive toxicology studies including detailed histopathology of numerous tissues. The results of these studies show no evidence of any endocrine mediated effects and no pathology of the endocrine organs. Consequently, Valent concludes that pyriproxyfen does not possess estrogenic or endocrine disrupting properties applicable to mammals.

C. Aggregate Exposure 1. Dietary exposure   i. Food. An evaluation of chronic dietary exposure including both food and drinking water has been performed for the U. S. population and various sub populations including infants and children. No acute dietary endpoint and dose was identified in the toxicology data base for pyriproxyfen, therefore, the Valent Corporation concludes that there is a reasonable certainty of no harm from acute dietary exposure. Chronic dietary exposure to pyriproxyfen residues was calculated for the U. S. population and 25 population subgroups assuming tolerance level residues, processing factors from residue studies, and 100% of the crop treated. The analyses included residue data for all existing uses, pending uses, and proposed new uses. ii. Drinking water. Since pyriproxyfen is applied outdoors to growing agricultural crops, the potential exists for pyriproxyfen or its metabolites to reach ground water or surface water that may be used for drinking water. Because of the physical properties of pyriproxyfen, it is unlikely that pyriproxyfen or its metabolites can leach to potable ground water. To quantify potential exposure from drinking water, surface water concentrations for pyriproxyfen were estimated using Generic Expected Environmental Concentration ( GENEEC) 1.3. 2. Non dietary exposure. Pyriproxyfen is currently registered for use on residential non food sites. Pyriproxyfen is the active ingredient in numerous registered products for flea and tick control. Formulations include foggers,

VerDate Dec< 13> 2002 17: 55 Mar 06, 2003 Jkt 200001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 07MRN1. SGM 07MRN1 11096 Federal Register / Vol. 68, No. 45 / Friday, March 7, 2003 / Notices aerosol sprays, emulsifiable concentrates, and impregnated materials ( pet collars). With the exception of the pet collar uses, consumer use of pyriproxyfen typically results in acute and short term intermittent exposures.

D. Cumulative Effects There are no other pesticidal compounds that are structurally related to pyriproxyfen and have similar effects on animals. In consideration of potential cumulative effects of pyriproxyfen and other substances that may have a common mechanism of toxicity, there are currently no available data or other reliable information indicating that any toxic effects produced by pyriproxyfen would be cumulative with those of other chemical compounds. Thus, only the potential risks of pyriproxyfen have been considered in this assessment of aggregate exposure and effects. Valent will submit information for EPA to consider concerning potential cumulative effects of pyriproxyfen consistent with the schedule established by EPA at ( 62 FR 42020 August 4, 1997) and other subsequent EPA publications pursuant to the Food Quality Protection Act.

E. Safety Determination 1. U. S. population. Chronic exposure to the overall U. S. population is estimated to be 0.002984 mg/ kg/ bwt day, representing 0.9% of the Reference Dose ( RfD). The results of the chronic dietary exposure assessment demonstrate that estimates of chronic dietary exposure for all existing, pending and proposed uses of pyriproxyfen are well below the chronic RfD of 0.35 mg/ kg/ bwt day. The estimated chronic dietary exposure from food for the overall U. S. population and many non child/ infant subgroups is from 0.002123 to 0.003884 mg/ kg/ bwt day, 0.607 to 1.100% of the RfD. Generally, the Agency has no cause for concern if total residue contribution is less than 100% of the RfD. Valent concludes that there is a reasonable certainty that no harm will result to the overall U. S. population or any nonchild infant subgroups from aggregate, chronic dietary exposure to pyriproxyfen residues. 2. Infants and children   i. Safety factor for infants and children. In assessing the potential for additional sensitivity of infants and children to residues of pyriproxyfen, FFDCA section 408 provides that EPA shall apply an additional margin of safety, up to 10 fold, for added protection for infants and children in the case of threshold effects unless EPA determines that a different margin of safety will be safe for infants and children. The toxicological data base for evaluating prenatal and postnatal toxicity for pyriproxyfen is complete with respect to current data requirements. There are no special prenatal or postnatal toxicity concerns for infants and children, based on the results of the rat and rabbit developmental toxicity studies or the 2 generation reproductive toxicity study in rats. Valent concludes that reliable data support use of the standard 100 fold uncertainty factor and that an additional uncertainty factor is not needed for pyriproxyfen to be further protective of infants and children. ii. Chronic dietary exposure and risk infants and children. For the most highly exposed sub population, children 1 to 6 years of age, exposure is calculated to be 0.007438 mg/ kg/ bwt day, or 2.1% of the RfD. Using the conservative exposure assumptions, the percentage of the RfD that will be utilized by chronic dietary ( food only) exposure to residues of pyriproxyfen ranges from 0.002601 mg/ kg/ bwt day for nursing infants, up to 0.007438 mg/ kg/ bwt day for children ( 1 to 6 years of age), 0.743 to 2.125% of the RfD, respectively. EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Valent concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate, chronic dietary exposure to pyriproxyfen residues. iii. Drinking water. The average 56   day concentration predicted in the simulated pond water was 0.16 parts per billion ( ppb). Using standard assumptions about body weight and water consumption, the chronic exposure to pyriproxyfen from this drinking water would be 4.57 x 10 6 and 1.6 x 10 5 mg/ kg/ bwt day for adults and children, respectively; 0.0046% of the RfD 0.35 mg/ kg/ day for children. Based on this worse case analysis, the contribution of water to the dietary risk is negligible. iv. Non dietary exposure. Chronic residential post application exposure and risk assessments were conducted to estimate the potential risks from pet collar uses. The risk assessment was conducted using the following assumptions: Application rate of 0.58 mg active ingredient day, average body weight for a 1   6 year old child of 10 kg, the active ingredient dissipates uniformly through 365 days the label instruct to change collar ( once a year), 1% of the active ingredient is available for dermal and inhalation exposure per day assumption from Draft EPA Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( December 18, 1997). The assessment also assumes an absorption rate of 100%. This is a conservative assumption since the dermal absorption was estimated to be 10%. The estimated chronic term margin of exposure ( MOE) was 61,000 for children, and 430,000 for adults. The risk estimates indicate that potential risks from pet collar uses do not exceed the Agency's level of concern.

F. International Tolerances There are no presently existing Codex maximum residue levels for pyriproxyfen. [ FR Doc. 03   5315 Filed 3   6   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0011; FRL   7290   1]

Sulfentrazone; Notice of Filing Pesticide Petitions to Establish Tolerances 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   0011, must be received on or before April 7, 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: Shaja R. Brothers, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   3194; e mail address: brothers. shaja@ 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 VerDate Dec< 13> 2002 17: 55 Mar 06, 2003 Jkt 200001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 07MRN1. SGM 07MRN1


[Federal Register Volume 85, Number 98 (Wednesday, May 20, 2020)]
[Rules and Regulations]
[Pages 30589-30592]
[FR Doc No: 2020-10667]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 85, No. 98 / Wednesday, May 20, 2020 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0454; Product Identifier 2019-SW-113-AD; Amendment
39-19911; AD 2020-09-15]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus Helicopters Model AS332C, AS332C1, AS332L, and AS332L1
helicopters. This AD was prompted by a report of vibrations around the
12Hz frequency due to the specific helicopter configuration. This AD
requires removing the removable parts of the dual hoist installation or
removing the de-icing system. This AD also allows, for certain
helicopters, revising the Rotorcraft Flight Manual (RFM) for your
helicopter and installing a placard as an optional method of
compliance. The FAA is issuing this AD to address the unsafe condition
on these products.

DATES: This AD becomes effective May 20, 2020.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of May 20, 2020.
    The FAA must receive comments on this AD by July 6, 2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this final rule, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.airbus.com/helicopters/services/technical-support.html. You may
view this service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort
Worth, TX 76177. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0454.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0454; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the European Union Aviation Safety Agency (EASA) AD, any
service information that is incorporated by reference, any comments
received, and other information. The street address for Docket
Operations is listed above. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aerospace
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-
3218; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2018-0142R1, dated December 9, 2019
(referred to after this as the Mandatory Continuing Airworthiness
Information, or ``the MCAI''), to correct an unsafe condition for
certain Airbus Helicopters Model AS332C, AS332C1, AS332L, and AS332L1
helicopters. EASA advises that during the first flight of an Airbus
Helicopters Model AS332L helicopter after a retrofit that re-installed
the de-icing system, vibrations around the 12Hz frequency were
observed. Subsequent flight tests and analysis determined that this
vibration is due the specific helicopter configuration. Factors that
contributed to the vibration included simultaneous installation of
riveted main frames X3855 and X5295 (pre-Airbus Helicopter modification
0722907), additional weight created by parts of the rotor de-icing
system on the main rotor head (the distributor and de-icing harnesses),
and removable parts (hoist arm and hoists) of the dual hoist
installation. EASA advises that this condition, if not corrected, could
generate divergent aeromechanic coupling between the helicopter
structure and the rotor, possibly resulting in mechanical failure of
structural parts and loss of control of the helicopter.
    EASA issued Emergency AD 2018-0142-E, dated July 6, 2018, for
certain Model AS332C, AS332C1, AS332L, and AS332L1 helicopters, which
required the removal of removable parts of the dual hoist installation
or removal of the de-icing system. Since EASA Emergency AD 2018-0142-E,
dated July 6, 2018, was issued, additional flight tests demonstrated
that Model AS332L and AS332L1 helicopters do not exhibit the vibration
at 12Hz when limiting the operational flight envelope and Vne (never-
exceed speed). As a result, EASA advises that revising the RFM for
Model AS332L and AS332L1 helicopters to incorporate certain limitations
and installing a locally made placard is an optional method of
compliance for Model AS332L and AS332L1 helicopters.
    You may examine the MCAI in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0454.

Related Service Information Under 1 CFR Part 51

    Airbus Helicopters has issued Emergency Alert Service Bulletin
AS332 01.00.91, Revision 1, dated December 4, 2019 (AS332 01.00.91 Rev
1). This service information describes procedures for removing parts of
the

dual hoist installation or removing the de-icing system.
    Airbus Helicopters has also issued Emergency Alert Service Bulletin
AS332 01.00.96, Revision 0, dated December 4, 2019. This service
information describes procedures for amending the RFM of Model AS332L
and AS332L1 helicopters to limit the flight envelope and the Vne and
installing a placard. This service information also describes
procedures for removing parts of the dual hoist installation or
removing the de-icing system.
    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.

Other Related Service Information

    Airbus Helicopters issued Emergency Alert Service Bulletin AS332
01.00.91, Revision 0, dated July 3, 2018 (AS332 01.00.91 Rev 0). AS332
01.00.91 Rev 0 contains the same procedures as AS332 01.00.91 Rev 1;
however, AS332 01.00.91 Rev 1 removes Model AS332L and AS332L1
helicopters from the effectivity.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
and service information referenced above. The FAA is issuing this AD
after evaluating all pertinent information and determining the unsafe
condition exists and is likely to exist or develop on other products of
the same type design.

Requirements of This AD

    This AD requires accomplishing the actions specified in the service
information described previously.

FAA's Justification for Immediate Adoption and Determination of the
Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C.) authorizes agencies to dispense with notice and comment
procedures for rules when the agency, for ``good cause,'' finds that
those procedures are ``impracticable, unnecessary, or contrary to the
public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without seeking comment prior to the
rulemaking. Similarly, Section 553(d) of the APA authorizes agencies to
make rules effective in less than thirty days, upon a finding of good
cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule
because of vibrations around the 12Hz frequency that are due to the
specific helicopter configuration, which could generate divergent
aeromechanic coupling between the helicopter structure and the rotor,
possibly resulting in mechanical failure of structural parts and loss
of control of the helicopter. The FAA determined a compliance time of 7
days is required to correct the unsafe condition. This compliance time
is shorter than the time necessary for the public to comment and for
publication of the final rule.
    Accordingly, notice and opportunity for prior public comment are
impracticable pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the
reasons stated above, the FAA finds that good cause exists pursuant to
5 U.S.C. 553(d) for making this amendment effective in less than 30
days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and was not preceded by notice and opportunity for public
comment. However, the FAA invites you to send any written relevant
data, views, or arguments about this AD. Send your comments to an
address listed under the ADDRESSES section. Include ``Docket No. FAA-
2020-0454; Product Identifier 2019-SW-113-AD'' at the beginning of your
comments. The FAA specifically invites comments on the overall
regulatory, economic, environmental, and energy aspects of this AD. The
FAA will consider all comments received by the closing date and may
amend this AD based on those comments.
    The FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this AD.

Interim Action

    The FAA considers this AD interim action. If final action is later
identified, the FAA might consider further rulemaking then.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 12 helicopters of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
              Labor cost                  Parts cost         Cost per  product         Cost on U.S.  operators
----------------------------------------------------------------------------------------------------------------
Up to 12 work-hours x $85 per hour =                $0  Up to $1,020...............  Up to $12,240.
 Up to $1,020.
----------------------------------------------------------------------------------------------------------------

                                      Estimated Costs for Optional Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                 Labor cost                               Parts cost                  product        operators
----------------------------------------------------------------------------------------------------------------
7 work-hours x $85 per hour = $595..........  Negligible........................            $595          $7,140
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is 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.

Regulatory Findings

    The FAA 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, and
    (2) Will not affect intrastate aviation in Alaska.

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):

2020-09-15 Airbus Helicopters: Amendment 39-19911; Docket No. FAA-
2020-0454; Product Identifier 2019-SW-113-AD.

(a) Effective Date

    This AD becomes effective May 20, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Helicopters Model AS332C, AS332C1,
AS332L, and AS332L1 helicopters, certificated in any category,
equipped with a dual hoist installation and de-icing system, except
those that have Airbus Helicopters modification 0722907 installed in
production.

(d) Subject

    Joint Aircraft Service Component (JASC) Code 2500, Cabin
Equipment/Furnishings; 3000, Ice/Rain Protection System; 5300,
Fuselage Structure (General).

(e) Reason

    This AD was prompted by a report of vibrations around the 12Hz
frequency due to the specific helicopter configuration. The FAA is
issuing this AD to address this condition, which could generate
divergent aeromechanic coupling between the helicopter structure and
the rotor, possibly resulting in mechanical failure of structural
parts and loss of control of the helicopter.

(f) Compliance

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

(g) Required Actions

    Within 7 days after the effective date of this AD: Remove the
removable parts of the dual hoist installation or remove the de-
icing system in accordance with the instructions of section 3.B of
Airbus Helicopters Emergency Alert Service Bulletin AS332 01.00.91,
Revision 1, dated December 4, 2019, or Section 3.B.2 of Airbus
Helicopters Emergency Alert Service Bulletin AS332 01.00.96,
Revision 0, dated December 4, 2019, as applicable to your
helicopter, except you are not required to contact Airbus
Helicopters.

(h) Optional Method of Compliance

    For Airbus Helicopter Model AS332L or AS332L1 helicopters:
Revising the Rotorcraft Flight Manual for your helicopter by
inserting the information specified in Appendix 4A, 4B, or 4C of
Airbus Helicopters Emergency Alert Service Bulletin AS332 01-00.96,
Revision 0, dated December 4, 2019, as applicable to your helicopter
model and configuration, and installing a locally made placard on
the instrument panel, in accordance with the instructions of section
3.B.1 of Airbus Helicopters Emergency Alert Service Bulletin AS332
01-00.96, Revision 0, dated December 4, 2019, is an acceptable
method for compliance with the requirements of paragraph (g) of this
AD.

(i) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using Airbus Helicopters Emergency Alert Service
Bulletin AS332 01.00.91, Revision 0, dated July 3, 2018.

(j) Special Flight Permit

    Special flight permits may be issued in accordance with 14 CFR
21.197 and 21.199 to operate the helicopter to a location where the
helicopter can be modified as specified in paragraph (g) of this AD,
provided the Rotorcraft Flight Manual revisions and the locally made
placard specified in paragraph (h) of this AD are in place.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
Manager, Safety Management Section, Rotorcraft Standards Branch,
FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone 817-222-
exception occurred on : 2020-10667.htm
exception occurred on : 2020-10667.htm
5110; email 9-ASW-FTW-AMOC[email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, notify your
principal inspector or lacking a principal inspector, the manager of
the local flight standards district office or certificate holding
district office, before operating any aircraft complying with this
AD through an AMOC.

(l) Related Information

    (1) The subject of this AD is addressed in the European Union
Aviation Safety Agency (EASA) AD 2018-0142R1, dated December 9,
2019. This EASA AD may be found in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0454.
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (m)(3) and (4) of this AD.

(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) Airbus Helicopters Emergency Alert Service Bulletin AS332
01.00.91, Revision 1, dated December 4, 2019.
    (ii) Airbus Helicopters Emergency Alert Service Bulletin AS332
01.00.96, Revision 0, dated December 4, 2019.
    (3) For service information identified in this AD, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
https://www.airbus.com/helicopters/services/technical-support.html.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177.
    (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, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 13, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-10667 Filed 5-19-20; 8:45 am]
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[Federal Register: March 5, 2010 (Volume 75, Number 43)]
[Notices]
[Page 10249]
[DOCID:fr05mr10-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12686-003]

Baker County; Notice of Preliminary Permit Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Competing
Applications

February 25, 2010.
    On February 25, 2010, Baker County filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the 3.4 megawatt Mason Dam
Hydroelectric Project, located on the Powder River, in Baker County,
Oregon. The proposed project would use the Bureau of Reclamation's
existing Mason Dam, which impounds Phillips Lake. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed project would consist of: (1) A proposed intake
structure and penstock, (2) a proposed powerhouse with generating
unit(s) having a total installed capacity of 3.4 MW, (3) an existing
transmission line and possible additional new transmission line(s), and
(4) appurtenant facilities. The project would have an annual generation
of 7,982 MWh, which would be sold to a local utility.
    Applicant Contact: Jason Yencopal, Baker County Project Manager,
1995 Third Street, Baker City, OR 97814.
    FERC Contact: Kenneth Hogan,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site (http://www.ferc.gov/docs-filing/ferconline.asp) under the
``eFiling'' link. For a simpler method of submitting text only
comments, click on ``Quick Comment.'' For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>call toll-free at
(866) 208-3676; or, for TTY, contact<PHONE_NUMBER>. Although the
Commission strongly encourages electronic filing, documents may also be
paper-filed. To paper-file, mail an original and eight copies to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-12686) in the docket number field to access
the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-4614 Filed 3-4-10; 8:45 am]
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