4475 Federal Register / Vol. 68, No. 19 / Wednesday, January 29, 2003 / Notices 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. Despite the potential for exposure to S metolachlor in drinking water and from non dietary, non occupational exposures, the assessment presented above demonstrates that the high levels of safety exist for current and proposed uses of S metolachlor; it is not expected that aggregate exposure from all sources will exceed 100% of the RfD. Therefore, one can conclude there is a reasonable certainty that no harm will result from aggregate exposure to S metolachlor. 2. Infants and children. FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database. Based on the current toxicological data requirements, the database relative to prenatal and postnatal effects for children is complete. A full consideration of the available reproductive toxicity data supporting Smetolachlor demonstrates no increased sensitivity to infants and children. Therefore, it is concluded that an additional uncertainty factor is not warranted to protect the health of infants and children and that the cRfD at 0.1 mg/ kg/ day is appropriate for assessing aggregate risk to infants and children from use of S metolachlor. Based on the aggregate assessment described above, the percent of the cRfD that will be utilized by aggregate exposure to residues of S metolachlor is less than 0.2% for non nursing infants and children 1 to 6 years old, and 0.1% for children 7 to 12 years old. 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. Despite the potential for exposure to S metolachlor in drinking water and from non dietary, non occuptional exposure, the assessment described above demonstrates that it is not expected that aggregate exposure from all sources provides for a large margin of safety and will exceed 100% of the RfD. Therefore, based on the completeness and reliability of the toxicity data and the exposure assessment, it is concluded there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to Smetolachlor residues. F. International Tolerances There are no Codex Alimentarius Commission maximum residue levels ( MRL's) established for residues of Smetolachlor in or on raw agricultural commodities. [ FR Doc. 03   2019 Filed 1   28   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0001; FRL   7287   6]

Lactofen; Notice of Filing Pesticide Petitions to Establish Tolerances for Certain Pesticide Chemicals 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 certain pesticide chemicals in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0001, must be received on or before February 28, 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 ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   6224; 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 the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0001. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in EPA's Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper VerDate Dec< 13> 2002 18: 08 Jan 28, 2003 Jkt 200001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 29JAN1. SGM 29JAN1 4476 Federal Register / Vol. 68, No. 19 / Wednesday, January 29, 2003 / Notices 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 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   0001. 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   0001. 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   0001. 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   0001. 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.

VerDate Dec< 13> 2002 18: 08 Jan 28, 2003 Jkt 200001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 29JAN1. SGM 29JAN1 4477 Federal Register / Vol. 68, No. 19 / Wednesday, January 29, 2003 / Notices 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 pesticide petitions as follows proposing the establishment and/ or amendment of regulations for residues of certain pesticide chemicals 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 these petitions contain data or information regarding the elements set forth in FFDCA section 408d) 2); 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.

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

Dated: January 17, 2003. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions The petitioner's 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 petitioner and represent the views of the petitioner. The petitions summaries announce the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemicals residues or an explanation of why no such method is needed.

Valent U. S. A. Corporation PP 8F3591 and PP 9F3798 EPA has received pesticide petitions ( 8F3591 and 9F3798) from Valent U. S. A. Corporation, 1333 North California Boulevard, Suite 600, Walnut Creek, California 94596   8025 proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR 180.432 by establishing tolerances for residues of the herbicide lactofen, 1( carboethoxy) ethyl 5[ 2 chloro 4( trifluoromethyl) phenoxy] 2 nitrobenzoate, in or on the raw agricultural commodities ( RACs) cottonseed at 0.01 part per million ( ppm), cotton gin byproducts at 0.02 ppm, and peanut nutmeats at 0.01 ppm. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petitions. Additional data may be needed before EPA rules on the petitions.

A. Residue Chemistry 1. Plant metabolism. The nature of the residue in plants is adequately understood based on plant metabolism studies on cotton, peanut, soybean, and tomato. The Health Effects Division ( HED) Metabolism Assessment Review Committee ( MARC) met on April 4, 2000, considered all of the metabolism studies submitted to date and concluded that only the parent compound needs to be regulated for plant commodities, provided that pre harvest intervals exceed 45 days. 2. Analytical method. Adequate analytical methodology is available for detecting and measuring levels of lactofen in or on RACs with a limit of detection ( LOD) that allows monitoring of food with residues at or above the level of the proposed tolerances. The method, RM   28D, has been successfully radio validated in conjunction with a tomato metabolism study and has undergone a successful independent laboratory validation trial. This method was also successfully validated by EPA's Analytical Chemistry Laboratory using peanut nutmeats and cottonseed. In general, the analytical method has a LOD of 0.005 ppm and limit of quantitation ( LOQ) of 0.01 ppm in crops. 3. Magnitude of residues. Adequate lactofen residue data are available for cotton and peanuts. An adequate number of field trials distributed throughout cotton and peanut growing areas of the United States have been conducted on these crops to determine lactofen residues resulting from the application of lactofen at the maximum labeled or proposed use rate. i. Cotton. Residues of lactofen were each < 0.01 ppm, in/ on cottonseed ( n= 14) harvested 59   127 days following a single postemergence soil directed application of lactofen at 0.4 lb active ingredient per acre ( lb active ingredient/ acre) ( 2x the single application rate) and in/ on cottonseed ( n= 10) harvested 23   108 days following the last of two postemergence directed applications at 0.4 lb active ingredient/ acre application ( 2x the maximum seasonal rate). With one exception, residues of lactofen were also each < 0.01 ppm, in/ on cotton gin byproducts ( gin trash) ( n= 11) derived from cotton harvested 69   108 days following two applications at 0.2 lb active ingredient/ acre. One gin trash sample bore residues of lactofen at 0.03 ppm, but confirmatory analyses of this sample detected lactofen at < 0.01   0.02 ppm, and residues of lactofen were < 0.01 ppm, in the duplicate treated sample from the same trial. In a single processing study, residues of lactofen were < 0.01 ppm, in/ on cottonseed harvested 76 days following the last of two directed applications of lactofen at 0.6 lb active ingredient/ acre application ( 1.2 lb active ingredient/ acre/ season, 3x rate). Residues of lactofen were < 0.01 ppm in samples of meal, hulls, oil, ( crude and refined) and soapstock. All these data support proposed tolerance for lactofen in/ on cottonseed at 0.01 ppm, and in/ on cotton, gin byproducts at 0.02 ppm. No separate tolerances are needed for cotton processed commodities. ii. Peanuts. In 8 field trials, residues of lactofen were each < 0.01 ppm, in/ on 16 samples of peanut nutmeats and hulls harvested 65   71 days following the last of 2 broadcast applications of lactofen totaling 0.45 lb active ingredient/ acre ( 1x the maximum proposed rate). Residues of lactofen were also < 0.01 ppm, in/ on peanut nutmeats and hulls from 2 trials conducted at 2x and 5x the maximum seasonal rate. In a processing study, residues of lactofen were < 0.01 ppm in meal, oil, crude and refined, and soapstock processed from nutmeats treated at 3x and 5x the maximum proposed use rates. All these data support proposed tolerance for lactofen in/ on peanut nutmeats at 0.01 ppm. No separate tolerances are needed for peanut processed commodities.

B. Toxicological Profile 1. Acute toxicity. Lactofen has very low acute toxicity. The acute oral LD50 is 5.96 gram/ kilogram/ body weight ( g/ kg/ bwt) toxicity category IV, the acute dermal LD50 is > 2.0 g/ kg/ bwt toxicity category III and the acute inhalation LD50 is > 6.3 milligrams/ liter ( mg/ L) toxicity category IV. Lactofen is not a VerDate Dec< 13> 2002 18: 08 Jan 28, 2003 Jkt 200001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 29JAN1. SGM 29JAN1 4478 Federal Register / Vol. 68, No. 19 / Wednesday, January 29, 2003 / Notices skin sensitizer but is a very slight dermal irritant. 2. Genotoxicity. Lactofen has very little mutagenic or genotoxic activity. While a positive mutagenic response was reported in one trial of a Salmonella typhimurium/ mammalian microsome mutagenicity assay, this response was not repeated in the second assay conducted. In addition, lactofen did not appear to induce chromosomal aberrations, unscheduled deoxyribonucleic acid ( DNA) synthesis or inhibit DNA repair. 3. Reproductive and developmental toxicity. Reproduction and teratology studies indicate that adverse effects, including embryotoxicity, occur only at doses that are also maternally toxic. Since lactofen causes effects only at levels which also produce systemic toxicity, the compound is not a reproductive hazard. In a 2   generation reproduction study in rats, decreased pup weight and decreased absolute and relative weights of the spleen were first reported at approximately 26.2 milligrams/ kilogram/ day ( mg/ kg/ day) ( based on dose administered to the parental group). The same dose level elicited mortality and decreased male fertility in the parental groups. The no observed adversed effect level ( NOAEL) for both systemic and reproductive toxicity in this study was 2.6 mg/ kg/ day. In the developmental toxicity study in rats, effects were observed at the 150 mg/ kg/ day dose level consisting of decreases in fetal weight as well as skeletal abnormalities. This dose level also elicited signs of toxicity in the parental group. The NOAEL for this study was 50 mg/ kg/ day. Based on this NOAEL and an uncertainty factor ( UF) of 100, the acute reference dose ( RfD) for lactofen has been set at 0.50 mg/ kg/ day. Two developmental toxicity studies were conducted in rabbits. In the first study, pregnant rabbits were administered oral doses of 0, 5, 15, or 50 mg/ kg bwt/ day lactofen technical on days 6   18 of gestation. Maternal toxicity ( clinical signs and reduced weight gain) and developmental effects ( increased embryonic death, decreased litter size and increased post implantation loss) were reported at 15 and 50 mg/ kg. The Agency concluded that the data were insufficient to establish a clear NOAEL. In the second rabbit developmental toxicity study, pregnant rabbits were exposed to 0, 1, 4, or 20 mg/ kg bwt/ day oral doses on days 6   18 of gestation. Maternal toxicity ( reduced food consumption) was observed at 20 mg/ kg bwt/ day, but no developmental effects were observed at any dose. Therefore, the maternal NOAEL was 4 mg/ kg bwt/ day and the developmental NOAEL was greater than 20 mg/ kg bwt/ day. 4. Subchronic toxicity   i. Rats 4   week. Male and female rats were fed diets containing lactofen technical at concentrations of 0, 200, 1,000, 5,000, and 10,000 ppm, for 4 weeks. A slight increase in spleen weight was the basis for a lowest observed adversed effect level ( LOAEL) of 200 ppm, lowest dose tested ( LDT). At doses of 1,000 ppm, or higher, the following findings were reported: clinical signs of toxicity; decreased red blood cell ( RBC), hemoglobin, hematocrit, and increased white blood cell ( WBC); increased relative liver and spleen weights; and necrosis and pigmentation of hepatocytes. At 10,000 ppm, severe toxic signs were observed by day 7 and all animals were dead or killed in extremis by day 11. Hypocellularity of the spleen, thymus, and bone marrow was also observed in animals exposed to 10,000 ppm. ii. Rats 3   month. Lactofen technical was fed to male and female rats at dietary concentrations of 0, 40, 200, and 1,000 ppm, for 13 weeks. Histopathological changes in the liver and significant changes in clinical chemistry associated with the liver were observed in rats exposed to 1,000 ppm, dosage. Decreased RBC, hemoglobin and hematocrit values were also observed at 1,000 ppm. The NOAEL in this study was 200 ppm, 14.1 mg/ kg/ day. iii. Dogs 4   week. In a range finding study lactofen technical was fed in the diet of dogs at 0, 1,000, 3,000, and 10,000 ppm, for 4 weeks. Toxic effects noted in dogs fed 10,000 ppm, included decreased RBC count and hemocrit, and increased blood urea nitrogen ( BUN) and serum glutamic pyruvic transaminase ( SGPT). Food palatability problems led to greatly decreased feed consumption at higher dosages. The NOAEL appeared to be 1,000 ppm. iv. Mice 3   month. Groups of male and female mice were fed diets containing lactofen technical at concentrations of 0, 40, 200, 1,000, 5,000, and 10,000 for 13 weeks. At week 5, the dosage of the 40 ppm, groups was increased to 2,000 ppm. Treatment related mortality occurred at dosages above 1,000 ppm. The LOAEL was 200 ppm, 28.6 mg/ kg/ day based on:   Increased WBC; decreased hematocrit, hemoglobin and RBC.   Increased alkaline phosphatase, serum glutamic oxloacetic transaminase ( SGOT), SGPT, cholesterol and total serum protein levels.   Increased weights or enlargement of the spleen, liver, adrenals, heart, and kidney; histopathological changes of the liver, kidney, thymus, spleen, ovaries, and testes. In general, effects were slight in the 200 ppm groups, and moderate to severe in the 1,000 ppm groups. v. Peroxisome proliferation. Butler et al ( 1988) studied the effects of lactofen on peroxisome proliferation in mice exposed for 7 weeks to dietary concentrations of 2, 10, 50, and 250 ppm. Liver weight to body weight ratio, liver catalase, liver acyl CoA oxidase, liver cell cytoplasmic eosinophilia, nuclear, and cellular size, and peroxisomal staining were increased by the tumorigenic dose of lactofen, i. e. 250 ppm. Lower doses of lactofen had little to no effect on these parameters. This study indicates that lactofen induces peroxisome proliferation and further, that 50 ppm, 7 mg/ kg/ day, a dose which is not tumorigenic, would be considered a threshold dose in mice for peroxisome proliferation produced by lactofen. A subchronic study conducted in chimpanzees ( Couch and Erickson 1986), indicated no effect on clinical chemistry or histological endpoints that would suggest liver toxicity or peroxisome proliferation at doses up to 75 mg/ kg bwt/ day administered for 93 days. Therefore, Valent believes that 75 mg/ kg bwt/ day is a clear NOAEL for peroxisome proliferation observed in a species closely related to man. On January 17, 2001, the Mechanism of Toxicity Assessment Review Committee ( MTARC) reviewed the merits of the toxicological data supporting peroxisome proliferation as the proposed mode of action for lactofen. Based on the weight of evidence from guideline, as well as mechanistic studies, the MTARC concluded that there are sufficient data to classify lactofen as a non genotoxic hepatocarcinogen in rodents with peroxisome proliferation being a plausible mode of action. 5. Chronic toxicity. Lactofen causes adverse health effects when administered to animals for extended periods of time. These effects include proliferative changes in the liver, spleen, and kidney; hematological changes; and blood biochemistry changes. i. Mouse 18   month. In a dietary 18   month oncogenicity study in mice at dosages of 10, 50, and 250 ppm, lactofen technical, an increase in liver adenomas and carcinomas, cataracts, and liver pigmentation was observed at 250 ppm, a dose that clearly exceeded the maximum tolerance dose ( MTD). The lowest dose, 10 ppm, 1.4 mg/ kg/ day, was the LOAEL based on increased liver weight and hepatocytomegaly.

VerDate Dec< 13> 2002 18: 08 Jan 28, 2003 Jkt 200001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 29JAN1. SGM 29JAN1 4479 Federal Register / Vol. 68, No. 19 / Wednesday, January 29, 2003 / Notices ii. Rat 24   month. In a 2   year chronic feeding/ oncogenicity study of lactofen technical in rats at dosages of 0, 500, 1,000 ppm; and 2,000 ppm, in the diet, an increase in liver neoplastic nodules and foci of cellular alteration was observed in both sexes at 2,000 ppm. The NOAEL for systemic toxicity is 500 ppm, 2 mg/ kg/ day based on kidney and liver pigmentation. iii. Dog 12   month. In a 1   year study in dogs exposed to 40, 200, and 1,000 ppm; week 1   17 or 3,000 ppm; week 18   52 lactofen technical in their diet, the NOAEL was determined to be 200 ppm, ( 0.79 mg/ kg/ day) based on renal dysfunction and decreased RBC, hemoglobin hematocrit and cholesterol observed at 1,000/ 3,000 ppm. Based on this NOAEL and an uncertainty factor ( UF) of 100, the chronic RfD for lactofen has been set at 0.008 mg/ kg/ day. iv. Carcinogenicity. As a member of the diphenyl ether chemical family, lactofen is structurally related to four other chemicals that are oncogenic in rodents:   Sodium acifluorfen ( acifluorfen is a lactofen metabolite), nitrofen, oxyfluorfen, and fomesafen.   Sodium acifluorfen produces hepatocellular adenomas and carcinomas in mice but is negative in rats.   Nitrofen produces hepatocellular carcinomas in mice and pancreatic carcinomas in rats.   Oxyfluorfen produces marginally positive liver tumors in mice but is negative in rats.   Fomesafen produces hepatocellular adenomas and carcinomas in mice. The Cancer Peer Review Committee ( CPRC) evaluated the relevant data on the carcinogenic potential of lactofen in 1987 and classified lactofen as a B2 carcinogen Probable Human Carcinogen and assigned a Cancer Potency Factor ( Q1*) of 1.7 x 10 1 mg/ kg/ day 1, based on a interspecies scaling factor of 0.67. This Q1* has since been reduced to 1.19 x 10 1 mg/ kg/ day 1 based on recent EPA guidance indicating that 0.75 is a more appropriate interspecies scaling factor. The B2 classification is based on an increase in the combined incidence of liver adenomas and carcinomas in mice and increases in liver neoplastic nodules and foci of cellular alteration ( possible precursor of tumors) in rats. In 1996, and 1999, EPA proposed new cancer risk assessment guidelines which state that nonmutagenic carcinogens known to cause cancer via a threshold mechanism, such as peroxisome proliferation, could be assessed using a nonlinear margin of exposure ( MOE) approach rather than the Q1 * method. EPA has recently determined that lactofen acts via a peroxisome proliferation mechanism and is currently reevaluating its approach to the quantification of the cancer risk for lactofen. 6. Animal metabolism. In a rat metabolism study, lactofen was shown to metabolize to acifluorfen, 5[ 2 chloro 4( trifluoromethyl) phenoxy] 2 nitrobenzoate, which was eliminated via both urine and feces. While lactofen was the primary compound found in the feces, acifluorfen accounted for > 90% of the radioactivity in the urine. Negligible amounts of the administered radioactivity were found in any tissue with less than 0.8% of the administered radioactivity being found in the liver one of the main target organs. 7. Metabolite toxicology. Acifluorfen is also a hydrolytic metabolite of lactofen. The sodium salt of this benzoic acid is the registered herbicide, sodium acifluorfen. This product has a complete data base supporting registration with a RfD of 0.013 mg/ kg/ day and a Q1* of 5.30 x 10 2 mg/ kg/ day 1. Because lactofen and its metabolites are not retained in the body, the potential for acute toxicity from in situ formed metabolites is low. The potential for chronic toxicity of lactofen metabolites has been adequately addressed by an extensive battery of lactofen chronic toxicity testing. 8. Endocrine disruption. No special studies to investigate the potential for estrogenic or other endocrine effects of lactofen have been performed. However, a large and detailed toxicology data base exists for the compound including studies acceptable to the Agency in all required categories. These studies include evaluations of reproduction and reproductive toxicity and detailed pathology and histology of endocrine organs following repeated or long term exposure. These studies are considered capable of revealing endocrine effects and no such effects were observed.

C. Aggregate Exposure 1. Dietary exposure. A full battery of toxicology testing, including studies of acute, chronic, oncogenicity, developmental, mutagenicity, and reproductive effects is available for lactofen. For the following risk assessments, the NOAEL from the chronic oral toxicity study in dogs, 0.79 mg/ kg/ day, was selected as the chronic oral toxicity endpoint. Based on this NOAEL, and an UF of 100, the chronic RfD and the chronic population adjusted dose ( cPAD) for lactofen has been set at 0.008 mg/ kg/ day. The NOAEL from the rat developmental study, 50 mg/ kg/ day, was selected as the acute oral toxicity endpoint. Based on this NOAEL and an UF of 100, the acute RfD for lactofen has been set at 0.50 mg/ kg/ day. An acute adjusted dose ( aPAD) of 0.17 mg/ kg/ day was calculated using this endpoint and an additional Food Quality Protection Act ( FQPA) safety factor of 3. This aPAD will only be used to assess acute exposures to the females 13 to 50 year old population subgroup since it is derived from a developmental toxicity endpoint. No other acute endpoints were identified to assess acute exposures to other populations. i. Food. Dietary risk was considered for the currently registered uses of lactofen on soybeans, snap beans, and cotton and for the pending use on peanuts. Dietary risk assessments were done using the Dietary Exposure Evaluation Model ( DEEMTM), which incorporates consumption data generated in U. S. Department of Agriculture ( USDA) Continuing Surveys of Food Intakes by Individuals ( CSFII), 1989   1992. For chronic dietary risk assessments, the 3   day average of consumption for each subpopulation is combined with residues in commodities to determine average exposure in mg/ kg/ day. For refined acute dietary risk assessments, the entire distribution of consumption events for individuals is multiplied by a distribution of residues to obtain a distribution of exposures in mg/ kg/ day. This is a probabilistic analysis, referred to as `` Monte Carlo,'' and the risk is reported at the 99.9th percentile of exposure. Food monitoring data are not available from Food and Drug Administration ( FDA) or USDA for residues of lactofen. Therefore, only field trial data were used. A value of one half the LOQ, 0.005 ppm, was used to represent the residues in all treated commodities. Percent crop treated ( PCT) were incorporated for soybeans and snap beans, as reliable usage information was available for these commodities. The estimated risk from food is presented in the following table:

VerDate Dec< 13> 2002 18: 08 Jan 28, 2003 Jkt 200001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 29JAN1. SGM 29JAN1 4480 Federal Register / Vol. 68, No. 19 / Wednesday, January 29, 2003 / Notices TABLE 1.   DIETARY EXPOSURE AND RISK TO LACTOFEN FROM FOOD SOURCES Population Acute Endpoint Chronic Endpoint Cancer Endpoint2 Exposure mg/ kg/ day % aPAD Exposure mg/ kg/ day % aPAD Exposure mg/ kg/ day Risk U. S. population NA1 NA 1 x 10 6 < 0.1 1 x 10 6 8 x 10 8 Females 13 to 50 2 x 10 6 < 0.1 < 1 x 10 6 < 0.1 NA NA Children 1 to 6 NA1 NA 2 x 10 6 < 0.1 NA NA 1Acute endpoint applies only to females of childbearing age. 2Cancer risk is generally reported for the U. S. population.

ii. Drinking water. Environmental fate properties indicate that lactofen is not very persistent or mobile. Hydrolysis half lives are 10.7, 4.6, and < 1.0 days at pH 5, 7, and 9 at 40 ° C, respectively. This temperature most likely exceeds temperatures that lactofen would be expected to be exposed to under normal conditions, thus the hydrolysis rates are probably slower. Aerobic soil metabolism half lives range from 1 to 3 days. Lactofen has a low probability to contaminate drinking water because it has a short half life ( 3 days or less) and high binding potential( Koc> 1,000). Limited data suggest that lactofen conversion to acifluorfen in water is approximately 52%. The HED MARC has concluded that the residues of concern in drinking water are acifluorfen and amino acifluorfen. Insufficient information is available to estimate the amino acifluorfen concentration in water, but it is likely to be less than that of acifluorfen. Laboratory studies have shown that acifluorfen reaches its maximum concentration of 53.3% of applied lactofen at 7 days following application and it is most likely to form under the soil surface. Thus, the formed acifluorfen is not subject to drift, erosion, or runoff forces that contribute to surface water contamination. Surface water, however, could be contaminated with acifluorfen from lactofen applications via spray drift. The registrant also has conducted two prospective ground water studies which showed that neither lactofen nor acifluorfen from lactofen applications contaminate ground water. Therefore, in the following discussion, the potential exposure to lactofen from drinking water will address only potential surface water contamination with lactofen and acifluorfen. The Tier II estimated environmental concentration ( EEC) assessment in surface water uses a single site, or multiple single sites, which represents a high end exposure scenario from pesticide use on a particular crop or non crop use site. The EEC's for lactofen were generated for the standard Mississippi cotton scenario. The Agency has implemented the concept of index reservoirs ( IR) and the PCT area to better estimate potential residue level in drinking water sources. The scenarios used with EPA pesticide root zone model ( PRZM) and exposure analysis modeling systems ( EXAMS) to estimate lactofen in the `` standard pond'' were rerun with the IR for the cotton and soybean scenarios. The Agency has estimated that the PCT area for the Mississippi cotton scenario is 0.20 ( 20%). The Office of Pesticide Programs ( OPP) has calculated drinking water levels of comparison ( DWLOCs) for acute and chronic exposure to lactofen and acifluorfen from applications of lactofen in surface water. To calculate the DWLOC for acute exposure, the acute dietary food exposure from the DEEMTM analysis was subtracted from the aPAD. To calculate the DWLOC for chronic ( non cancer) exposure, the chronic dietary food exposure from the DEEMTM analysis was subtracted from the cPAD to obtain the acceptable chronic non cancer exposure to lactofen and acifluorfen in drinking water. A DWLOC cancer was calculated in a similar manner, assuming a negligible risk of 1 x 10 6. Assumptions used in calculating the DWLOCs include 70 kg bwt for the U. S. population, 60 kg bwt for adult females, 10 kg bwt for children, 2 liters of water consumption per day for adults, and 1 liter consumption for children.

TABLE 2.   DIETARY EXPOSURE AND RISK TO LACTOFEN FROM DRINKING WATER Population Acute Endpoint Chronic Endpoint Cancer Endpoint2 Exposure µ g/ L DWLOC µ g/ L Exposure µ g/ L DWLOC µ g/ L Exposure µ g/ L DWLOC µ g/ L U. S. population NA1 NA 0.022 280 0.012 0.3 Females 13 to 50 0.62 5,100 0.022 240

Children 1 to 6 NA1 NA 0.022 80

1 Acute endpoint applies only to females of childbearing age. 2 Cancer risk is generally reported for the U. S. population.

TABLE 3.   DIETARY EXPOSURE AND RISK TO ACIFLUORFEN1 FROM DRINKING WATER Population Acute Endpoint Chronic Endpoint Cancer Endpoint3 Exposure µ g/ L DWLOC µ g/ L Exposure µ g/ L DWLOC µ g/ L Exposure µ g/ L DWLOC µ g/ L U. S. population NA2 NA 0.99 140 0.34 0.7 Females 13 to 50 4.9 600 0.99 120

VerDate Dec< 13> 2002 18: 08 Jan 28, 2003 Jkt 200001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 29JAN1. SGM 29JAN1 4481 Federal Register / Vol. 68, No. 19 / Wednesday, January 29, 2003 / Notices TABLE 3.   DIETARY EXPOSURE AND RISK TO ACIFLUORFEN1 FROM DRINKING WATER   Continued Population Acute Endpoint Chronic Endpoint Cancer Endpoint3 Exposure µ g/ L DWLOC µ g/ L Exposure µ g/ L DWLOC µ g/ L Exposure µ g/ L DWLOC µ g/ L Children 1 to 6 NA2 NA 0.99 40

1 Acifluorfen derived from applications of lactofen. 2 Acute endpoint applies only to females of childbearing age. 3 Cancer risk is generally reported for the U. S. population.

HED has a concern if the DWLOC for any scenario is below the estimated environmental concentration from the models. All of the DWLOCs shown in the tables above exceed the estimated EECs. 2. Non dietary exposure. Lactofen is proposed only for agricultural uses and no home owner or turf uses. Thus, no non dietary risk assessment is needed.

D. Cumulative Effects Section 408( b)( 2)( D)( v) requires that the Agency must consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' Available information in this context include not only toxicity, chemistry, and exposure data, but also scientific policies and methodologies for understanding common mechanisms of toxicity and conducting cumulative risk assessments. For most pesticides, although the Agency has some information in its files that may turn out to be helpful in eventually determining whether a pesticide shares a common mechanism of toxicity with any other substances, EPA does not at this time have the methodologies to resolve the complex scientific issues concerning common mechanism of toxicity in a meaningful way. There are other pesticidal compounds that are structurally related to lactofen and have similar effects on animals. In consideration of potential cumulative effects of lactofen 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 lactofen would be cumulative with those of other chemical compounds. Thus, only the potential risks of lactofen have been considered in this assessment of aggregate exposure and effects. Valent will submit information for EPA to consider concerning potential cumulative effects of lactofen consistent with the schedule established by EPA in the Federal Register of August 4, 1997 ( 62 FR 42020) ( FRL 5734   6), and other subsequent EPA publications pursuant to FQPA. E. Safety Determination 1. U. S. population. Water is not expected to be a significant source of exposure for lactofen, as it degrades quickly in the environment to numerous degradates, including acifluorfen. EECs for lactofen and acifluorfen are well below the DWLOC for chronic, acute, and cancer risk. Therefore, the only significant source of human exposure to lactofen is in food. Residues of lactofen are generally non detectable at a LOQ of 0.005 ppm, in all food forms. The exposure is < 0.1% of the acute and chronic PAD for all population subgroups. Exposure is generally not of concern if it is less than 100% of the PAD. The estimated cancer risk for the U. S. population is 8 x 10 8, which is more than an order of magnitude less than the risk that is generally considered negligible 1 x 10 6. 2. Infants and children. As stated above, dietary exposure assessments, including drinking water, utilize less than 0.1% of the acute and chronic PADs for all population subgroups, including infants and children. Reproduction and developmental effects have been found in toxicology studies for lactofen but only at levels that were also maternally toxic. This indicates that developing animals are not more sensitive than adults. FQPA requires an additional safety factor of up to 10 for chemicals which present special risks to infants or children. Lactofen does not meet the criterion for application of an additional safety factor for infants and children. The FQPA Safety Factor Committee met on March 13, 2000 to evaluate the hazard and exposure data for lactofen and recommended that FQPA, safety factor for protection of infants and children should be reduced to 3x for lactofen. This safety factor was reduced to 3x by The FQPA, Safety Factor Committee because available data provide no indication of quantitative or qualitative increased susceptibility from in utero and/ or postnatal exposure to lactofen in rats. Information on the reproduction and developmental effects caused by the other diphenyl ether herbicides is not available to Valent. Additional time is needed for the Agency to evaluate the need for an additional safety factor related to these other chemicals. However, even if an additional safety factor were deemed necessary, the dietary exposures are still expected to be well below the established reference doses.

F. International tolerances.

There are no Codex maximum residue limits established for lactofen on cotton or peanut commodities, so there is no conflict between this proposed action and international residue limits. [ FR Doc. 03   2020 Filed 1   28   03; 8: 45 a m]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ FRL   7445   4; RCRA   2002   0029]

Land Disposal Restrictions: Treatment Standards for Mercury Bearing Hazardous Waste; Notice of Data Availability AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of data availability.

SUMMARY: This notice of data availability ( NODA) makes available to the public two studies conducted on the treatment of mercury wastes. The studies were initiated to help evaluate whether EPA could propose treatment and disposal alternatives to the current land disposal restriction ( LDR) treatment standard of mercury retorting. The studies were performed to assess conditions that affect the stability of waste residues resulting from the treatment of high mercury ( greater than 260 mg/ kg total mercury) wastes. This NODA also makes available the results of the peer review of these studies. As a result of our investigation, we have concluded that changes to our national regulations are impractical at this time. Additionally, this notice also provides information on how to use the existing treatability variance procedures to make site specific choices on alternatives to mercury recovery. The treatability studies and the results of the peer review are presented here only to provide information   we are not VerDate Dec< 13> 2002 19: 49 Jan 28, 2003 Jkt 200001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 29JAN1. SGM 29JAN1


 [Federal Register Volume 76, Number 142 (Monday, July 25, 2011)] [Notices] [Page 44322] [FR Doc No: 2011-18694]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-4057-000]

Shiloh III Wind Project, LLC; Supplemental Notice That Initial

Market-Based Rate Filing Includes Request for Blanket Section 204

Authorization

    This is a supplemental notice in the above-referenced proceeding of

Shiloh III Wind Project, LLC's application for market-based rate

authority, with an accompanying rate tariff, noting that such

application includes a request for blanket authorization, under 18 CFR

Part 34, of future issuances of securities and assumptions of

liability.

    Any person desiring to intervene or to protest should file with the

Federal Energy Regulatory Commission, 888 First Street, NE.,

Washington, DC 20426, in accordance with Rules 211 and 214 of the

Commission's Rules of Practice and Procedure (18 CFR 385.211 and

385.214). Anyone filing a motion to intervene or protest must serve a

copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with

regard to the applicant's request for blanket authorization, under 18

CFR Part 34, of future issuances of securities and assumptions of

liability, is August 8, 2011.

    The Commission encourages electronic submission of protests and

interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an

intervenor must create and validate an eRegistration account using the

eRegistration link. Select the eFiling link to log on and submit the

intervention or protests.

    Persons unable to file electronically should submit an original and

14 copies of the intervention or protest to the Federal Energy

Regulatory Commission, 888 First Street, NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in

the Commission's eLibrary system by clicking on the appropriate link in

the above list. They are also available for review in the Commission's

Public Reference Room in Washington, DC. There is an eSubscription link

on the Web site that enables subscribers to receive e-mail notification

when a document is added to a subscribed docket(s). For assistance with

any FERC Online service, please e-mail<EMAIL_ADDRESS>or

call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 19, 2011.

Nathaniel J. Davis, Sr.,

 Deputy Secretary.

[FR Doc. 2011-18694 Filed 7-22-11; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: August 22, 2007 (Volume 72, Number 162)]
[Notices]
[Page 46991-46993]
[DOCID:fr22au07-93]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-SFUND-2007-0707; FRL-8458-3]

Agency Information Collection Activities; Proposed Collection;
Comment Request; National Oil and Hazardous Substance Pollution
Contingency Plan (NCP) (Renewal); EPA ICR Number 1463.07, OMB Control
Number 2050-0096

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on January 31, 2008. Before submitting the ICR to
OMB for review and approval, EPA is soliciting comments on specific
aspects of the proposed information collection as described below.

DATES: Comments must be submitted on or before October 22, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
SFUND-2007-0707, by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Mail: EPA Docket Center, Environmental Protection Agency,
Superfund Docket, Mail Code 2822T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
     Hand Delivery: Superfund Docket, EPA West 3334, 1301
Constitution Ave., NW., Washington, DC 20004. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-SFUND-
2007-0707. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

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

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

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

FOR FURTHER INFORMATION CONTACT: S. Steven Chang, Assessment and
Remediation Division, Office of Superfund Remediation and Technology

Innovation (Mail Code 5204P), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703-
603-9017; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

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

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-SFUND-2007-0707 which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Superfund

Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Reading Room is 202-566-
1744, and the telephone number for the Superfund Docket is 202-566-
0276.
    Use http://www.regulations.gov to obtain a copy of the draft

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

What Information Is EPA Particularly Interested in?

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

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

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

What Information Collection Activity or ICR Does This Apply to?

    Affected entities: Entities potentially affected by this action are
state/tribal governments and individual community members who
voluntarily participate in the remedial phase of the Superfund program
and in associated community involvement activities throughout the
Superfund process.
    Title: National Oil and Hazardous Substances Pollution Contingency
Plan (NCP) (Renewal).
    ICR numbers: EPA ICR 1463.07, OMB Control Number 2050-0096.
    ICR status: This ICR is currently scheduled to expire on January
31, 2008. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: This Information Collection Request is a renewal ICR that
covers the remedial portion of the Superfund Program, as specified in
the Comprehensive Environmental Response, Compensation, and Liability
Act of 1980 as amended (CERCLA) and the National Oil and Hazardous
Substance Pollution Contingency Plan (NCP). All remedial actions
covered by this ICR (e.g., Remedial Investigations/ Feasibility
Studies) are stipulated in the statute (CERCLA) and are instrumental in
the process of cleaning up National Priorities List (NPL) sites to be
protective of human health and the environment. Some community
involvement activities covered by this ICR are not required at every
site (e.g., Technical Assistance Grants) and depend very much on the
community and the nature of the site and cleanup. All community
activities seek to involve the public in the cleanup of the sites, gain
the input of community members, and include the community's perspective
on the potential future reuse of Superfund NPL sites. Community
involvement activities can enhance the remedial process and increase
community acceptance and the potential for productive and useful reuse
of the sites.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 80
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 7,970.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: As
required.
    Estimated total annual burden hours: 71,165 hours.
    Estimated total annual costs: $572,415. This includes an estimated
annual burden cost of $61,245 for States and an estimated cost of
$511,170 for communities.

    Dated: August 15, 2007.
James E. Woolford,
Office Director, Office of Superfund Remediation and Technology
Innovation.
[FR Doc. E7-16596 Filed 8-21-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 12 (Thursday, January 19, 2012)]
[Proposed Rules]
[Pages 2664-2666]
[FR Doc No: 2012-858]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1415; Directorate Identifier 2011-NM-145-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
The Boeing Company Model 717-200 airplanes. This proposed AD was
prompted by reports of cracks found on the center section ribs of the
horizontal stabilizers. This proposed AD would require repetitive
inspections for cracking of the aft face of the left and right rib
hinge bearing lugs of the center section of the horizontal stabilizer;
and crack measurement, repairs, and installation of a new center
section rib if necessary. We are proposing this AD to detect and
correct cracks in the left and right bearing lugs of the rib hinge
spreading at the same time, which could result in failure of both hinge
bearing lugs. Failure of the hinge bearing lugs could result in the
inability of the horizontal stabilizer to sustain flight loads and
therefore reduce the controllability of the airplane.

DATES: We must receive comments on this proposed AD by March 5, 2012.

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 http://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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; phone:<PHONE_NUMBER>, extension 2; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet: https://www.myboeingfleet.com. You may
review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; 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 proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: George Garrido, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, California 90712-
4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2011-1415;
Directorate Identifier 2011-NM-145-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any

personal information you provide. We will also post a report
summarizing each substantive verbal contact we receive about this
proposed AD.

Discussion

    We have received reports of cracks found on the left, right, or, in
several instances, both of the center section ribs of the horizontal
stabilizer on Model MD-80 and MD-90 series airplanes. Two cracks were
reported on Model MD-80 series airplanes having accumulated between
23,700 and 41,963 total flight hours and between 23,300 and 35,294
total flight cycles. Nine cracks were reported on Model MD-90 series
airplanes having accumulated between 9,051 and 26,053 total flight
hours and between 8,939 and 25,260 total flight cycles. These cracks
were found on the aft face of the hinge bearing lugs of the horizontal
stabilizer. Undetected cracks in the left and right bearing lugs of the
rib hinge, if not corrected, could spread at the same time, which could
result in failure of both hinge bearing lugs, the inability of the
horizontal stabilizer to sustain flight loads, and consequent reduced
controllability of the airplane.
    The design of the horizontal rib on Model 717-200 airplanes is the
same rib design used on Model MD-80 and MD-90 series airplanes, and is
susceptible to the same failure mode. Therefore, Model 717-200
airplanes may also be subject to the identified unsafe condition.

Related Rulemaking

    We have issued similar rulemaking in AD 2011-01-11, Amendment 39-
16565 (76 FR 430, January 5, 2011), for The Boeing Company Model MD-90
airplanes, that requires repetitive high frequency eddy current (HFEC)
inspections for cracking on the hinge bearing lugs of the left and
right sides of the center section ribs of the horizontal stabilizer,
and related investigative and corrective actions if necessary.
    We have also issued NPRM 2011-NM-027-AD (76 FR 53346, August 26,
2011), for The Boeing Company Model DC-9-81 (MD-81), DC-9-82 (MD-82),
DC-9-83 (MD-83), DC-9-87 (MD-87), and MD-88 airplanes. That NPRM
proposes to require repetitive HFEC inspections for cracking of the
left and right rib hinge bearing lugs of the aft face of the center
section of the horizontal stabilizer; measuring crack length and
blending out cracks; and replacing the horizontal stabilizer center
section rib, if necessary.

Relevant Service Information

    We reviewed Boeing Alert Service Bulletin 717-55A0011, dated May
17, 2011. This service information describes procedures for repetitive
eddy current high frequency (ETHF) inspections for cracks on the aft
face on the left and right rib hinge bearing lugs of the center section
of the horizontal stabilizer; and crack measurement, repairs, post-
repair repetitive inspections, and installation of a new center section
rib if necessary.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between the Proposed AD and the Service
Information.''

Differences Between the Proposed AD and the Service Information

    Operators should note that, although the Accomplishment
Instructions of Boeing Alert Service Bulletin 717-55A0011, dated May
17, 2011, describe procedures for submitting inspection results, this
proposed AD would not require those actions.

 Costs of Compliance

    We estimate that this proposed AD affects 129 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
ETHF Inspection                    6 work-hours x $85               $0  $510 per inspection  $65,790 per
                                    per hour = $510                      cycle.               inspection cycle.
                                    per inspection
                                    cycle.
----------------------------------------------------------------------------------------------------------------

     We have received no definitive data that would enable us to
provide cost estimates for the on-condition labor costs specified in
this proposed AD. The estimated parts cost for a replacement rib is
$16,387.

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.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (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.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

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

The Boeing Company: Docket No. FAA-2011-1415; Directorate Identifier
2011-NM-145-AD.

(a) Comments Due Date

    We must receive comments by March 5, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 717-200
airplanes, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 5510, Horizontal Stabilizer Structure.

(e) Unsafe Condition

    This AD was prompted by reports of cracks found on the center
section ribs of the horizontal stabilizers. We are issuing this AD
to detect and correct cracks in the left and right bearing lugs of
the rib hinge spreading at the same time, which could result in
failure of both hinge bearing lugs. Failure of the hinge bearing
lugs could result in the inability of the horizontal stabilizer to
sustain flight loads and therefore reduce the controllability of the
airplane.

(f) Compliance

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

(g) Repetitive Eddy Current High Frequency (ETHF) Inspections

    Before the accumulation of 35,000 total flight cycles, or within
8,275 flight cycles after the effective date of this AD, whichever
occurs later: Do an ETHF inspection for cracks of the aft face on
the left and right rib hinge bearing lugs of the center section of
the horizontal stabilizer, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 717-55A0011, dated May
17, 2011. If no crack is found, repeat the inspection thereafter at
intervals not to exceed 10,500 flight cycles.

 (h) Crack Measurement

    If any crack is found during any inspection required by
paragraph (g) of this AD: Before further flight, measure the length
of the crack, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 717-55A0011, dated May 17, 2011.

(i) Blend Out Repair, ETHF Inspections, and Corrective Action for
Certain Crack Lengths

    For any crack that meets ``Condition 2A'' of Table 1 of 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 717-55A0011, dated
May 17, 2011: Do the actions in paragraphs (i)(1) and (i)(2) of this
AD.
    (1) Before further flight, do a blend out repair, in accordance
with the Accomplishment Instructions of Boeing Alert Service
Bulletin 717-55A0011, dated May 17, 2011.
    (2) Within 14,200 flight cycles after accomplishing the blend
out repair required by paragraph (i)(1) of this AD: Do an ETHF
inspection of the blend out repair area for cracking, in accordance
with the Accomplishment Instructions of Boeing Alert Service
Bulletin 717-55A0011, dated May 17, 2011. If no cracking is found,
repeat the inspection thereafter at intervals not to exceed 5,400
flight cycles.
    (i) If any crack is found during the ETHF inspection required by
paragraph (i)(2) of this AD: Before further flight, remove the
cracked center section rib of the horizontal stabilizer and install
a new center section rib, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 717-55A0011, dated May
17, 2011.
    (ii) Within 35,000 flight cycles after the installation of the
new center section rib, do the actions in paragraph (g) of this AD.

(j) Corrective Action for Certain Crack Lengths

    For any crack that meets ``Condition 2D'' of Table 1 of 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 717-55A0011, dated
May 17, 2011: Before further flight, remove the cracked center
section rib of the horizontal stabilizer and install a new center
section rib, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 717-55A0011, dated May 17, 2011.
Within 35,000 flight cycles after the installation of the new rib,
do the actions in paragraph (g) of this AD.

(k) No Reporting Requirement

    Although Boeing Alert Service Bulletin 717-55A0011, dated May
17, 2011, specifies to submit certain information to the
manufacturer, this AD does not include that requirement.

 (l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager Los Angeles Aircraft Certification Office (ACO),
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 ACO, send it to the
attention of the person identified in the Related Information
section of this AD.
    (2) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO, to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.

(m) Related Information

    (1) For more information about this AD, contact George Garrido,
Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles
Aircraft Certification Office (ACO), 3960 Paramount Boulevard,
Lakewood, California 90712-4137; phone:<PHONE_NUMBER>; fax: (562)
627-5210; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, Boeing
Commercial Airplanes, Attention: Data & Services Management, 3855
Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-0001;
phone:<PHONE_NUMBER>, extension 2; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet: https://www.myboeingfleet.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on January 6, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-858 Filed 1-18-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 66 (Wednesday, April 6, 2022)]
[Rules and Regulations]
[Pages 19789-19791]
[FR Doc No: 2022-07255]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2022-0277; Special Conditions No. 25-814-SC]

Special Conditions: Peregrine, Textron Aviation Model 400A
Airplane; Rechargeable Lithium Batteries

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Textron Aviation
(Textron) Model 400A airplane. This airplane, as modified by Peregrine,
will have a novel or unusual design feature when compared to the state
of technology envisioned in the airworthiness standards for transport
category airplanes. This design feature is a main ship rechargeable
lithum battery. The applicable airworthiness regulations do not contain
adequate or appropriate safety standards for this design feature. These
special conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: This action is effective on Peregrine on April 6, 2022. Send
comments on or before May 23, 2022.

ADDRESSES: Send comments identified by Docket No. FAA-2022-0277 using
any of the following methods:
     Federal eRegulations Portal: Go to https://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: Except for Confidential Business Information (CBI) as
described in the following paragraph, and other information as
described in title 14, Code of Federal Regulations (14 CFR) 11.35, 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 these special conditions.
    Confidential Business Information: Confidential Business
Information (CBI) is commercial or financial information that is both
customarily and actually treated as private by its owner. Under the
Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from
public disclosure. If your comments responsive to these special
conditions contain commercial or financial information that is
customarily treated as private, that you actually treat as private, and
that is relevant or responsive to these special conditions, it is
important that you clearly designate the submitted comments as CBI.
Please mark each page of your submission containing CBI as ``PROPIN.''
The FAA will treat such marked submissions as confidential under the
FOIA, and the indicated comments will not be placed in the public
docket of these special conditions. Submissions containing CBI should
be sent to Nazih Khaouly, Aircraft Systems, AIR-623, Technical
Innovation Policy Branch, Policy and Innovation Division, Aircraft
Certification Service, Federal Aviation Administration, 2200 South
216th Street, Des Moines, Washington 98198; telephone and fax 206-231-
3160; email [email protected]. Comments the FAA receives, which are
not specifically designated as CBI, will be placed in the public docket
for these special conditions.
    Docket: Background documents or comments received may be read at
https://www.regulations.gov/ at any time. Follow the online
instructions for accessing the docket or go to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nazih Khaouly, Aircraft Systems, AIR-
623, Technical Innovation Policy Branch, Policy and Innovation
Division, Aircraft Certification Service, Federal Aviation
Administration, 2200 South 216th Street, Des Moines, Washington 98198;
telephone and fax<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION: The substance of these special conditions
has been published in the Federal Register for public comment in
several prior instances with no substantive comments received.
Therefore, the FAA finds, pursuant to Sec.  11.38(b), that new comments
are unlikely, and notice and comment prior to this publication are
unnecessary.

Comments Invited

    The FAA invites interested people to take part in this rulemaking
by sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    The FAA will consider all comments received by the closing date for
comments. The FAA may change these special conditions based on the
comments received.

Background

    On November 30, 2021, Peregrine applied for a supplemental type
certificate for the installation of a True Blue Power TB40 main ship
rechargeable lithium battery in the Model 400A airplane. The Textron
Model 400A airplane is a twin-engine transport category business jet,
with a maxium passenger capacity of 11, and

has a maximum takeoff weight of 16,300 pounds.

Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14
CFR) 21.101, Peregrine must show that the Model 400A airplane, as
changed, continues to meet the applicable provisions of the regulations
listed in Type Certificate No. A16SW or the applicable regulations in
effect on the date of application for the change, except for earlier
amendments as agreed upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (e.g., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Peregrine Model 400A airplane
because of a novel or unusual design feature, special conditions are
prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the applicant apply for a supplemental type
certificate to modify any other model included on the same type
certificate to incorporate the same novel or unusual design feature,
these special conditions would also apply to the other model under
Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Textron Model 400A airplane must comply with the fuel
vent and exhaust emission requirements of 14 CFR part 34 and the noise
certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The Textron Model 400A airplane will incorporate the following
novel or unusual design features:
    Installation of True Blue Power TB40 main ship rechargeable lithium
battery.

Discussion

    Rechargeable lithium batteries are considered to be a novel or
unusual design feature in transport category airplanes, with respect to
the requirements in Sec.  25.1353. This type of battery has certain
failure, operational, and maintenance characteristics that differ
significantly from those of the nickel-cadmium and lead-acid
rechargeable batteries currently approved for installation on transport
category airplanes. These batteries introduce higher energy levels into
airplane systems through new chemical compositions in various battery-
cell sizes and construction. Interconnection of these cells in battery
packs introduces failure modes that require unique design
considerations, such as provisions for thermal management.
    Special Condition 1 requires that each individual cell within a
battery be designed to maintain safe temperatures and pressures.
Special Condition 2 addresses these same issues but for the entire
battery. Special Condition 2 requires that the battery be designed to
prevent propagation of a thermal event, such as self-sustained,
uncontrolled increases in temperature or pressure from one cell to
adjacent cells.
    Special Conditions 1 and 2 are intended to ensure that the cells
and battery are designed to eliminate the potential for uncontrollable
failures. However, a certain number of failures will occur due to
various factors beyond the control of the designer. Therefore, other
special conditions are intended to protect the airplane and its
occupants if failure occurs.
    Special Conditions 3, 7, and 8 are self-explanatory. Special
Condition 4 clarifies that the flammable-fluid fire-protection
requirements of Sec.  25.863 apply to rechargeable lithium battery
installations. Section 25.863 is applicable to areas of the airplane
that could be exposed to flammable fluid leakage from airplane systems.
Rechargeable lithium batteries contain electrolyte that is a flammable
fluid.
    Special Condition 5 requires each rechargeable lithium battery
installation to not damage surrounding structure or adjacent systems,
equipment, or electrical wiring from corrosive fluids or gases that may
escape in such a way as to cause a major or more severe failure
condition. Special Condition 6 requires each rechargeable lithium
battery installation to have provisions to prevent any hazardous effect
on airplane structure or systems caused by the maximum amount of heat
it can generate due to any failure of it or its individual cells. The
means of meeting special conditions 5 and 6 may be the same, but they
are independent requirements addressing different hazards. Special
Condition 5 addresses corrosive fluids and gases, whereas special
condition 6 addresses heat.
    Special Condition 9 requires rechargeable lithium batteries to have
``automatic'' means, for charge rate and disconnect, due to the fast-
acting nature of lithium battery chemical reactions. Manual
intervention would not be timely or effective in mitigating the hazards
associated with these batteries.
    These special conditions apply to all rechargeable lithium battery
installations in lieu of Sec.  25.1353(b)(1) through (4) at Amendment
25-123 or Sec.  25.1353(c)(1) through (4) at earlier amendments. Those
regulations remain in effect for other battery installations.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Textron Model 400A airplane. Should Peregrine apply at a later date for
a supplemental type certificate to modify any other model included on
Type Certificate No. A16SW to incorporate the same novel or unusual
design feature, these special conditions would apply to that model as
well.

Conclusion

    This action affects only a certain novel or unusual design feature
on one model of airplane. It is not a rule of general applicability and
affects only the applicant who applied to the FAA for approval of this
feature on the airplane.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

Authority Citation

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Textron Aviation Model 400A airplanes,
as modified by Peregrine.
    In lieu of Sec.  25.1353(b)(1) through (4) at amendment 25-123, or
Sec.  25.1353(c)(1) through (4) at earlier amendments, each
rechargeable lithium battery installation must:
    1. Be designed to maintain safe cell temperatures and pressures
under all foreseeable operating conditions to prevent fire and
explosion.
    2. Be designed to prevent the occurrence of self-sustaining,
uncontrollable increases in temperature or pressure, and automatically
control the charge rate of each cell to protect against adverse
operating conditions, such as cell imbalance, back charging,
overcharging and overheating.
    3. Not emit explosive or toxic gases, either in normal operation or
as a result

of its failure that may accumulate in hazardous quantities within the
airplane.
    4. Meet the requirements of Sec.  25.863.
    5. Not damage surrounding structure or adjacent systems, equipment,
or electrical wiring from corrosive fluids or gases that may escape in
such a way as to cause a major or more-severe failure condition.
    6. Have provisions to prevent any hazardous effect on airplane
structure or systems caused by the maximum amount of heat it can
generate due to any failure of it or its individual cells.
    7. Have a failure sensing and warning system to alert the flight
crew if its failure affects safe operation of the airplane.
    8. Have a monitoring and warning feature that alerts the flightcrew
when its charge state falls below acceptable levels if its function is
required for safe operation of the airplane.
    9. Have a means to automatically disconnect from its charging
source in the event of an over-temperature condition, cell failure or
battery failure.

    Note: A battery system consists of the battery, battery charger,
and any protective monitoring and alerting circuitry or hardware
inside or outside of the battery. It also includes vents (where
necessary) and packaging. For the purpose of these special
conditions, a battery and the battery system is referred to as a
battery.

    Issued in Kansas City, Missouri, on April 1, 2022.
Patrick R. Mullen,
Manager, Technical Innovation Policy Branch, Policy and Innovation
Division, Aircraft Certification Service.
[FR Doc. 2022-07255 Filed 4-5-22; 8:45 am]
BILLING CODE 4910-13-P