78459 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov./ edocket. Title: NSPS for Lime Manufacturing ( 40 CFR part 60, subpart HH) ( OMB Control No. 2060   0063, EPA ICR Number 1167.07). This is a request to renew an existing approved collection that is scheduled to expire on January 31, 2003. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: The New Source Performance Standards ( NSPS) for Lime Manufacturing Plants were proposed on May 3, 1977 and promulgated on April 26, 1984. These standards apply to each rotary lime kiln used in lime manufacturing, which commenced construction, modification or reconstruction after May 3, 1977. The standards do not apply to facilities used in the manufacture of lime at kraft pulp mills. The purpose of this NSPS is to control the emissions of particulate matter ( PM) from lime manufacturing plants, specifically from the operation of the rotary lime kilns. The standards limit particulate emissions to 0.30 kilogram per megagram ( 0.60 lb/ ton) of stone feed, and limit opacity to 15% when exiting from a dry emission control device. This information is being collected to assure compliance with 40 CFR part 60, subpart HH. There are three types of reporting requirements for owners or operators of facilities under this NSPS: ( 1) Notifications ( e. g., notice for new construction or reconstruction, anticipated and actual startup dates, initial performance test, and demonstration of the CMS); ( 2) a report on the results of the performance test; and ( 3) semiannual reports of instances of occurrence and duration of any startup, shutdown, or malfunctions. The purpose of the notifications are to inform the Agency or delegated authority when a source becomes subject to this standard. Performance tests are conducted to ensure that the new plants operate within the boundaries outlined in the standard. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. Under this standard the data collected by the affected industry is retained at the facility for a minimum of two years and made available for inspection by the Administrator. The Administrator has judged that PM emissions from lime manufacturing plants cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Owners/ operators of lime manufacturing plants must notify EPA of construction, modification, startups, shutdowns, malfunctions and performance test dates, as well as provide reports on the initial performance test and annual excess emissions. The industry costs associated with the information collection activity in the standards are capital costs and O& M costs associated with continuous emissions monitoring and labor costs associated with recordkeeping and reporting. In order to ensure compliance with the standards promulgated to protect public health, adequate reporting and recordkeeping is necessary. In the absence of such information, enforcement personnel would be unable to determine whether the standards are being met on a continuous basis, as required by the Clean Air Act. 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 are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 42 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; 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. Respondents/ Affected Entities: Lime Manufacturing Plants. Estimated Number of Respondents: 53. Frequency of Response: On occasion, initial, and semiannual. Estimated Total Annual Hour Burden: 4,434 hours. Estimated Total Annual Cost: $ 91,500. Changes in the Estimates: There is an increase of 244 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is due to an increase in the number of existing facilities subject to this standard resulting from the availability of more accurate data.

Dated: December 10, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02   32399 Filed 12   23   02; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OPP   2002   0283; FRL   7277   5]

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

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2002   0283, must be received on or before January 23, 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: Bipin Gandhi, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8380; e mail address: gandhi. bipin@ 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, pesticide manufacturer, or antimicrobial pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Industry ( NAICS 111), e. g., Crop production.   Industry ( NAICS 112), e. g., Animal production.   Industry ( NAICS 311), e. g., Food manufacturing.

VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78460 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices   Industry ( NAICS 32532), e. g., Pesticide manufacturing.   Industry ( NAICS 32561), e. g., Antimicrobial pesticide. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2002   0283. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please 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   2002   0283. 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   2002   0283. 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 VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78461 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices 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   2002   0283. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP   2002   0283. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI To the Agency?

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

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

II. What Action is the Agency Taking?

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

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

Dated: December 10, 2002. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs.

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

PP 2E6475 EPA has received a pesticide petition ( PP 2E6475) from BASF Corporation: 3000 Continental Drive  North, Mount Olive, NJ 07828   1234; proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for 2 bromo 2 nitro 1,3 propanediol ( Bronopol) ( CAS Reg. No. 52   51   7) in or on all raw agricultural commodities when used as an in can preservative in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. Residue chemistry data are not generally required by EPA regarding tolerance exemption petitions. Consequently no plant metabolism data have been generated. 2. Analytical method. Since this petition is for an exemption from the requirement of a tolerance, an enforcement analytical method for 2 bromo 2 nitro 1, 3 propanediol is not needed. 3. Magnitude of residues. Based on the proposed amount of 2 bromo 2 nitro 1,3 propanediol to be used in the final products ( 0.04% or less by weight of the total formulation) and the recommended frequency and rates of application to growing crops, raw agricultural commodities after harvest, and animals, the residues are expected to be essentially undetectable and not toxicologically significant.

B. Toxicological Profile 1. Acute toxicity. Bronopol was given as single oral doses of 200, 280, 390, 550, or 770 mg/ kg, as a solution in distilled water, to groups of ten male and ten female rats. The rats were observed for a seven day period. Overt signs of toxicity were seen immediately after dosing with 280 mg/ kg or more, and within 1 hour in males given 200 mg/ kg. The signs included sedation, wheezing, gasping, nasal exudate, cyanosis, increased salivation and ataxia. Animals given 550 or 770 mg/ kg VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78462 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices also had slow or labored respiration, and two females became prostrate. Most deaths occurred within 19 hours after dosing, but some occurred up to 72 hours. There were no gross abnormalities at autopsy of the decedents or in animals killed at the end of the study. The LD50 in male rats was 307 mg/ kg and in female rats was 342 mg/ kg. In a further oral study groups of ten male rats were given single doses of Bronopol at 36, 54, 80, 120, 270, 400, or 600 mg/ kg, as a suspension in 0.4% aqueous Cellosize solution. The rats were observed for up to ten days after treatment. Overt signs of toxicity were seen within 30 minutes after dosing with 80 mg/ kg or more, and included wheezing, gasping or labored respiration and nasal exudate. Animals in the higher dose groups were inactive and adopted a low or hunched body position. Deaths occurred in these groups up to five days after treatment; macroscopic findings in the decedents included evidence of gastrointestinal irritation at 120 mg/ kg or more, enlarged and dark red adrenals in some animals given 400 or 600 mg/ kg, small spleens in a few rats given 80 or 120 mg/ kg, and pale areas on the livers at 600 mg/ kg. At terminal autopsy, one animal given 400 mg/ kg also had a small spleen. Statistical analysis of the mortality data indicated that the LD50 was 254 mg/ kg. In an acute inhalation study a group of six rats and two groups of eight rats were exposed for 6 hour periods to Bronopol dust at nominal concentrations of 5, 0.5, or 0.05 mg per liter air respectively. The animals were then kept under observation for up to 14 days. Exposure of rats to 5 mg dust per liter air caused severe eye irritation, dyspnea and loss of bodyweight. Exposure to 0.5 mg dust per liter air caused only slight eye irritation and mild dyspnea, while no definite signs of irritation were observed in animals exposed to 0.05 mg dust per air. In a second inhalation study four groups of 10 rats ( 5 males and 5 females) were exposed to Bronopol at 0 ( filtered air negative control), 0.038, 0.089 or 0.588 mg/ by inhalation ( nose only) over a period of 4 hours. Exposure was followed by an observation period of 14 days. In the high dose group one animal died overnight after exposure, and 2 more animals were killed during the following day because of severe eye inflammation. Signs of marked irritancy were recorded in high dose animals but disappeared by the third observation day. Minor treatment related signs ( piloerection and hunched posture) were observed on the day of treatment in some intermediate dose rats. There was no effect in the low dose group. There were no treatment related effects on body weight or treatment related pathological findings except for local dermatitis and ulceration in 2 high dose animals possibly attributable to dermal exposure to the test article. Several studies as summarized below determined 2 bromo 2 nitro 1,3 propanediol to be irritant to the eye. Bronopol in polyethylene glycol 300   0.1 ml volumes of 0.5 or 2% Bronopol in polyethylene glycol 300 were instilled into one eye of each of six rabbits, three rabbits per concentration. The other eye in each case was treated with solvent only. The 2% solution was instilled only once, whereas the 0.5% solution was instilled on four successive days. The 2% solution of Bronopol in polyethylene glycol 300, instilled once, caused moderate inflammation and slight conjunctival edema which subsided after 5 hours. The 0.5% solution, instilled on four successive days, had effects similar to those produced by the solvent alone. Bronopol in saline  Two drops of a solution containing 0.5% w/ v Bronopol in normal saline were applied to one eye of three New Zealand White rabbits once daily on four successive days. The other eye ( control) of each rabbit was treated with normal saline. The eyes were examined for irritation at 15 and 30 minutes, and at 1, 2, 3, 4, and 24 hours after treatment each day. One rabbit developed moderate inflammation and very slight edema of the conjunctiva between two and four hours after the first application, but this subsided within 24 hours. No other reactions were observed. Bronopol in polyethylene glycol 400  One drop of Bronopol at 0 ( vehicle control), 0.5, 2, or 5% in polyethylene glycol 400 was added to one eye of 12 rabbits, 3 animals per test concentration. The other eye of each rabbit was left untreated. After 24 hours the eyes were irrigated with 300 ml of lukewarm water. Ocular reactions were assessed according to the FDA method at 1, 24, 48, and 72 hours, and then 7, 14, and 21 days after treatment. Immediately after treatment, with all the solutions, most rabbits exhibited head shaking and blinking and/ or rubbing the treated eye. After 1 hour all the animals developed conjunctival reactions which had largely subsided by 24 hours, except in the most severely affected cases. One rabbit treated with 5% Bronopol had conjunctival reactions that persisted for 72 hours. The lower concentrations produced less severe and less persistent conjunctival reactions, and none of the concentrations elicited reactions in the cornea or iris. It was concluded that Bronopol in polyethylene glycol 400 was irritant at 5% but not at 2 or 0.5%, when instilled once only into the eye of the New Zealand White rabbit. Bronopol is also irritant to the skin. In a cumulative irritancy study dilutions of Bronopol at 0 ( vehicle control), 0.1, 0.5, 1, 2.5, and 5% in petrolatum was applied daily for 21 days to the same site on the back of 8 men. The treatment sites were occluded. Readings were made daily on a scale of 0 to 4. The skin irritancy threshold concentration of Bronopol was approximately 0.5 to 1.0%. To determine if the subjects had been sensitized, they were further elicited after a 10 day rest period. Two subjects reacted at 0.5 and 1% Bronopol. One reacted at 0.1%. These men received a product use test consisting of applications ( without patching) to the cubital fossa twice daily for 7 days. These were negative. In a single, 4 hour, semi occluded dermal application of undiluted Bronopol to the skin of six rabbits produced severe dermal reactions, including eschar formation, necrosis and severe edema. Other adverse dermal reactions noted were slight hemorrhage of the dermal capillaries, blanching or brown discoloration of the skin, desquamation and scar tissue. The absence of fur growth was also occasionally noted on day fourteen with further effects indicative of corrosion. A primary irritation index of 6.2 was produced and evidence of corrosive effects were noted fourteen days after treatment. Undiluted Bronopol was found to be a severe irritant/ corrosive to rabbit skin. An acute rabbit dermal toxicity study gave a dermal LD50 of > 2,000 mg/ kg body weight. The study was based on the EEC, OECD and EPA/ OPPTS guidelines. A single oral dose of 2,000 mg/ kg body weight of the test material preparation in 0.5% Tylose was applied in a group of ten rats ( five males and five females) to the clipped epidermis ( dorsal and dorsolateral parts of the trunk) and covered by a semi occlusive dressing for 24 hours. No mortality occurred. Signs of toxicity noted in the 2,000 mg/ kg groups comprised poor general state, dyspnea and apathy. Findings were observed until including study day 1. The following skin effects were observed at the application site: white discoloration, erythema, edema, eczematoid skin change, scaling, and crust formation. Findings were observed until termination of the study. The animals did not gain weight during the first post exposure observation week but restarted to gain weight thereafter. No abnormalities were noted in the animals necropsied at the end of the study,

VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78463 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices except in the skin of the application site, where incrustation and full thickness necrosis ( 9/ 10 animals) was observed. Under the conditions of this study, the acute dermal median lethal dose ( LD50) of the test substance was found to be greater than 2000 mg/ kg body weight for male and female animals. 2 bromo 2 nitro 1,3 propanediol is classed as a weak skin sensitizer as indicated in four Magnusson and Kligman guinea pig skin sensitization studies as summarized below. Study 1  The test method was the Magnusson and Kligman guinea pig maximization test, but using 10 test animals, 4 treated controls and 4 untreated controls. Induction in the test animals was by intradermal injections of 0.03% w/ v Bronopol in saline and Complete Freunds Adjuvant in the shoulder region. The induction process was supplemented 7 days later by 1.5% w/ v Bronopol in distilled water applied under occlusion to the injection sites. Fourteen days later the animals were challenged on the shaved flank by occluded patch with 0.4% w/ v Bronopol in distilled water. Twentyfour hours after the challenge the patch was removed and the reaction site examined 24 and 48 hours after removal. A further 3 challenges were made at either 1 or 2 week intervals. The treated controls were 4 guinea pigs treated the same as the test animals except that the test substance was omitted from the intradermal injection and the covered patch induction procedures. At each challenge 4 previously untreated animals were challenged as per the test animals. This group formed the untreated control. In the Magnusson and Kligman Maximization test, sensitization is normally assessed after one challenge. At this stage in this test there was no sensitization. One animal was sensitized after 2 challenges and a further animal after 3 challenges. In this test 2/ 10 animals sensitized after one challenge is classified as a mild sensitizer ( Grade II), but since 3 challenges were necessary before 2/ 10 animals were sensitized, the sensitization potential must be regarded as less than mild, hence Bronopol was found to be a weak sensitizer by this method. Study 2  Induction was carried out as in Study 1 except that 9 guinea pigs were used; induction was 0.02% Bronopol in saline and induction supplementation was 6   7 days later with 5% Bronopol in saline. Fourteen days later the animals were challenged ( 24 hour occluded patch) with 1% Bronopol in saline. One week later the animals were subjected to a crossreaction challenge with 2% formalin. Further challenges were made with Bronopol and formalin after 2 and 3 weeks. Any challenge reactions were recorded after 24 and 48 hours. 2/ 9 animals showed sensitization reactions to Bronopol at challenge 1. Animals were not challenged with Bronopol at challenge 2. No sensitization reactions were seen at challenge 3 and 1/ 9 animals showed an equivocal reaction at challenge 4. 1/ 9 animals showed an equivocal reaction to formalin at challenge 2, but there was no evidence of cross reaction at challenges 3 and 4. It was concluded that Bronopol was a weak sensitizer under the conditions of this test. There was no significant evidence of cross reaction to challenge with formalin. Study 3  Induction was carried out as in Study 1 except that 9 guinea pigs were used; induction was 0.02% Bronopol in saline and induction supplementation was 6   7 days later with 2.5% Bronopol in saline. Fourteen days later the animals were challenged ( 24 hour occluded patch) with 0.25% Bronopol in saline; a second challenge was made after a further 7 days. Any challenge reactions were recorded after 24 and 48 hours. There was no evidence of sensitization in the 9 animals tested at either challenge, and it was concluded that Bronopol was not a sensitizer under the conditions of this test. Study 4  Induction was carried out as in Study 1 except that induction was 0.02% Myacide BT ( a minimum of 98% Bronopol) in saline and induction supplementation was 6   7 days later with 2.5% Myacide BT in saline. Fourteen days later the animals were challenged ( 24 hour occluded patch) with 0.25% Myacide BT in saline; a second challenge was made after a further 7 days. Any challenge reactions were recorded after 24 and 48 hours. There was no evidence of sensitization in the 10 animals tested at either challenge, and it was concluded that Myacide BT was not a sensitizer under the conditions of this test. The overall conclusion was that Bronopol has a very low, and variable, sensitization potential in the stringent Magnusson and Kligman guinea pig maximization test and is at most a weak sensitizer in this species. There was no evidence that the animals had become sensitized to formalin. 2. Genotoxicty. Mutagenicity studies including in vitro/ in vivo in mouse erythrocytes ( micronucleus assay), chromosomal aberration test in human lymphocytes, Salmonella typhimurium plate ( Ames) tests with and without activation were negative. Bronopol did not induce mutations in the in vitro bacterial mutagenicity assay ( TX 86004) or the V79 cell mutation assay ( TX 86043), neither was there evidence of activity in assays for host mediated bacterial mutagenicity or dominant lethality conducted in mice TX 74034). Furthermore, there was no increase in the incidence of micronuclei in polychromatic erythrocytes of bone marrow from male and female mice, 24, 48, or 72 hours after administration of single oral doses up to a maximum tolerated level of 160 mg/ kg ( TX 86001). However, weak in vitro clastogenic activity was detected in cultured human lymphocytes exposed for 24 hours, in the absence of S   9, to Bronopol at 30 µ g/ ml ( TX 86049). Bronopol is normally self stabilizing at about pH 4 in aqueous media, but decomposes at elevated temperature and more alkaline pH to release formaldehyde as a breakdown product. Under the conditions of the human lymphocyte chromosome assay, only about 10% of an initial 30 µ g/ ml concentration of Bronopol in the culture medium ( pH 6.9) could be detected by analysis after 2 hours incubation at 370 C ( DT 86029), and a formaldehyde concentration of 4.2 µ g/ ml was found at this time ( DT 86030); the calculated value for formaldehyde released from complete breakdown of the 30 µ g/ ml concentration of Bronopol is 4.5 µ g/ ml. Formaldehyde shows clastogenic properties in vitro that include the induction of chromosome aberrations in human lymphocytes. Furthermore, in a lymphocyte assay conducted in house ( TX 86050), formaldehyde, in the absence of S   9 activation, elicited chromosome damage that was qualitatively and quantitatively similar to that seen in the assay of Bronopol. These findings, supported by the analytical data, indicate that the in vitro clastogenicity seen with Bronopol is due to its breakdown to formaldehyde. Although formaldehyde is a clastogen in vitro, its reactivity precludes distribution in vivo, so it is inactive in bone marrow and germ cells. The relative instability of Bronopol, like that of other non carcinogenic formaldehyde releasing agents, does not allow it to transport formaldehyde to these sites. In contrast, the carcinogen, hexamethylphosphoramide ( HMPA), is more stable and requires metabolic activation to release formaldehyde; as a result, HMPA is clastogenic in bone marrow and has adverse effects in germ cells. In conclusion, the testing of Bronopol over a wide range of genetic endpoints has revealed only a single adverse finding, namely weak in vitro clastogenicity, and this result is clearly VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78464 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices attributable to the release of formaldehyde from Bronopol under the conditions of the lymphocyte assay. The consensus of negative findings in shortterm in vitro tests, together with the negative finding in an in vivo test for chromosome damage and the absence of oncogenicity in the life span studies in rats and mice ( see below), indicates that Bronopol does not present a genotoxic hazard. In a 2 year rat ( drinking water) chronic toxicity and tumorgenicity, Bronopol dissolved in tap water was dosed to 28 day old rats in 4 groups ( 45 male and 45 female in the main groups and 15 male and 15 female in the satellite groups) via the drinking water for 104 weeks at 0 ( untreated control), 10, 40, and 160 mg/ kg/ day. The main groups were reserved for evaluation of tumorigenic potential and were not used for blood and urine samples during the study; the satellite groups were used for blood and urine samples during the study and were not included in the tumorigenicity assessment. The results at the various dose levels may be summarized as follows: 160 mg/ kg/ day   Reduced grooming activity during the final year of treatment.   Significantly increased mortality.   Reduced weight gain from week 3 onwards among males and from week 7 onwards among females.   Lower food intake among males from week 13 onwards.   Marked reduction in water intake throughout the dosing period and an associated reduction in urine volume noted at weeks 25, 52, and 103.   Increase incidence of progressive glomerulonephrosis in males and females.   At week 52, urine repeatedly positive for hemoglobin in 4/ 10 males and 1/ 10 females, at week 77 in 4/ 10 males and 3/ 10 females, and at week 103 in 10/ 10 males and 1/ 10 females.   Stomach lesions in 20 males and 15 females and the gastric lymph nodes showed dilation of the sinusoids in 4 males and 5 females.   Squamous metaplasia, inflammation or atrophic acini in the salivary glands of 12 males and 11 females. 40 mg/ kg/ day   Reduced weight gain from weeks 27 to 78 among males.   Lower food intake from weeks 53 to 78 among males.   Moderate reduction in water intake throughout the dosing period.   At week 77, urine repeatedly positive for hemoglobin in 6/ 10 males and at week 103 in 3/ 10 males.   Stomach lesion in 1 male.   Squamous metaplasia, inflammation or atrophic acini in the salivary glands of 12 males and 2 females. 10 mg/ kg/ day   Small but definite reduction in water intake throughout the dosing period.   At week 77, urine repeatedly positive for hemoglobin in 2/ 10 males and at week 103 in 2/ 9 males.   Stomach lesions in 1 male and 1 female.   Squamous metaplasia and/ or inflammation or atrophic acini in the salivary glands of 5 males and 1 female. Control   At week 52, urine repeatedly positive for hemoglobin in 1/ 10 males and 0/ 10 females, at week 77 in 2/ 10 males and 0/ 10 females, and at week 103 in 3/ 10 males and 1/ 10 females.   Stomach lesions in 1 male and 2 females.   Squamous metaplasia and/ or inflammation or atrophic acini in the salivary glands of 3 males and 2 females. The evidence of toxic effects related to the administration of Bronopol was a reduction in food intake, impaired food utilization efficiency associated with reduced bodyweight gain, and increased mortality. Changes in the stomach and gastric lymph nodes were attributed to the irritant effect of Bronopol. Unpalatability reduced the water intake and was associated with a reduced output of urine, an increased incidence of hemoglobinuria and an exacerbation of the spontaneous incidence of progressive glomerulonephrosis. Treatment with Bronopol exacerbated a spontaneous change in the salivary glands. These effects were dose related and apart from a small effect on water intake that was related to palatability, there was no evidence of toxicity at 10 mg/ kg/ day. There was no evidence to suggest that the administration of Bronopol affected the tumor incidence. In summary, the study gave a systemic no observed adverse effect level ( NOAEL) of 10 mg/ kg/ day, a lowest effect level ( LEL) of 40 mg/ kg/ day and found 2 bromo 2 nitro 1,3 propanediol ( Bronopol) to be not carcinogenic. 3. Reproductive and developmental toxicity. In a two generation reproduction study in rats Bronopol was administered to rats in the drinking water at concentrations of 25, 70, or 200 mg/ kg/ day. Thirteen males and 26 females were treated for a minimum of 80 days prior to mating. They were mated on two separate occasions to produce the F1a and F1b litters. Weanlings from the F1b litters were randomly selected ( 13 males and 26 females) to become parents of the next generation. The F1 parents were treated for a minimum of 87 days prior to mating, and were mated on two separate occasions to produce the F2a and F2b litters. In the F0 generation, one female from each of the control and low dose groups, and one male and five females from the high dose group died or were sacrificed in extremis during the study; in the F1 generation, one female from each of the low, mid and high dose groups died before the end of the study. There were no treatment related aspects, so these deaths were considered to have been incidental to Bronopol. Food consumption for the high dose group was consistently lower than controls for the F0 males, for F0 females during the initial two weeks of treatment and the lactation periods for both mates, and for F1 females during the lactation period of the F2a mate. Water consumption was reduced in all treated groups, in a dose related manner, throughout most of the study; this contributed to the lower achieved dosages of Bronopol that animals received, namely 22.55, 55.2, or 147 mg/ kg. The female fertility index for the high dose group was slightly lower than control at the F1 mate only. Mean body weights of the offspring of the F0 and F1 high dose parents ( F1a and F1b, and F2a and F2b, respectively) were lower than the control throughout the lactation periods. Mean body weights of the F1b pups from the low and middose groups were slightly lower than control on day 21 of the lactation period. There were no other test articlerelated macroscopic or microscopic changes. There was a dose related increase in the kidney weights of treated F0 females, though the difference between the low dose group and controls was minimal. In the high dose group animals there was a decrease in the absolute weights of the livers, and possibly also the hearts, of F1 males, and in the absolute liver weights of F2b males and females; these females also had lower absolute kidney weights. In conclusion, ingestion of Bronopol elicited signs of toxicity at all dosages, though the only reproductive or litter parameter affected at the 25 and 70 mg/ kg/ day dosages was body weight of F1b pups at weaning, where a minimal decrease was seen. An early rat dermal developmental toxicity study gave a maternal NOAEL > 40 mg/ kg/ day ( HDT) considering 2 bromo 2 nitro 1,3 propanediol as a severe dermal irritant in rats. Further development toxicity studies have been carried out for both the rat and the rabbit. In the rat study three groups of 24 timed mated female rats were dosed once daily, orally by gavage, with VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78465 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices solutions of Bronopol at dose levels of 10, 28, or 80 mg/ kg/ day from days 6 to 15 of pregnancy, inclusive. A similar group of females were dosed with the vehicle ( purified water acidified to pH 4) by the same route and over the same period, and served as controls. Maternal clinical signs, bodyweights and food consumption were recorded. On day 20 of pregnancy, the females were killed and a necropsy was performed. Numbers of corpora lutea and live and dead implantations were recorded. Live fetuses were weighed, sexed and examined for external and visceral abnormalities. Two thirds of the fetuses were also examined for skeletal abnormalities. There was evidence of maternal toxicity following oral gavage administration of Bronopol at 80 mg/ kg/ day, characterized by retarded bodyweight gain over days 6 to 7 of pregnancy. There was no evidence of maternal toxicity at either 10 or 28 mg/ kg/ day. There was no evidence of developmental toxicity at any of the dose levels investigated. There may be an association of treatment at 80 mg/ kg/ day with advanced ossification of sacral arches and at 28 and 80 mg/ kg/ day with advanced ossification of the forelimb phalanges. However, neither of these findings in these groups was unusually advanced when compared to historical background data. In a second study using rabbit groups of 18, 19, or 20 timed mated female animals were dosed daily between 7 and 19 days of pregnancy, inclusive, by the oral route with aqueous solutions of Bronopol at dose levels of 0 ( control), 5, 20, 40, and 80 mg/ kg/ day. Day 0 of pregnancy was the day of mating. 80 mg/ kg/ day was selected as a level which should elicit maternal effects. However, in the event that the effects may have been too severe, 40 mg/ kg/ day was selected as the next highest level known to be tolerated by the pregnant rabbit. The lower dose level of 5 mg/ kg/ day and the intermediate dose level of 20 mg/ kg/ day were expected to be ` no effect' levels. Maternal clinical condition, bodyweight, and food consumption were recorded. The females were killed on day 28 of pregnancy and a necropsy was performed. They were weighed, sexed and examined for external, visceral, and skeletal abnormalities. At 80 mg/ kg/ day, Bronopol elicited severe maternal toxicity at the onset of dosing. The animals recovered after dosing ceased, but the outcome of pregnancy was affected. There was embryotoxicity characterized by growth retardation and a slightly higher than expected incidence of fetal abnormalities. This embryotoxicity was considered likely to be related to the maternal toxicity. At 40 mg/ kg/ day, which was considered to be the highest level likely to be tolerated by the pregnant rabbit without eliciting severe maternal toxicity, there was no evidence of adverse effects of treatment on the pregnant rabbit or developing embryos. This dose level was therefore considered to be the ` no effect' level of Bronopol with regard to developmental toxicity. 4. Subchronic toxicity. A 13 week rat gavage study showed a NOAEL of 20 mg/ kg/ day and a lowest observed adverse effect level ( LOAEL) of 80 mg/ kg/ day. Bronopol as a solution in distilled water was dosed to CD rats ( 4 groups of 20 males and 20 females) by oral gavage once per day, seven days per week for 13 weeks at 0 ( untreated control), 20, 80, and 160 mg/ kg/ day. Reaction to treatment was as follows: 160 mg/ kg/ day  Severe respiratory distress and abdominal distension; reduced bodyweight gain and food consumption; death of 22 males and 14 females ( includes 4 male and 3 female rats which replaced rats dying after one dose); all surviving rats were killed on day 9; autopsy showed gaseous and fluid distension of the gastro intestinal tract in the majority of decedents; ulceration, epithelial hyperplasia and hyperkeratosis or congested vessels in the stomachs of 2 males and 4 females. 80 mg/ kg/ day  Severe respiratory distress and abdominal distension, the latter sign confined to 6 males and 6 females which subsequently died. At week 6, only 4 males and 2 females showed slight respiratory difficulty. Seven males and 9 females died with autopsy showing gaseous and fluid distension of the gastro intestinal tract; reduced bodyweight gain and food consumption for the first week of treatment only; renal changes in 2 males. 20 mg/ kg/ day  In one male, respiratory distress, which subsequently regressed; renal changes in 2 males. A 13 week dog gavage study showed a NOAEL of 8 mg/ kg/ day and LOAEL of 20 mg/ kg/ day. Bronopol dissolved in water was dosed to Beagle dogs ( 4 groups of 3 males and 3 females) by oral gavage once per day, seven days per week for 3 months ( 13 weeks) at 0 ( untreated control), 4, 8, and 20 mg/ kg/ day. One pair of dogs was dosed at levels of 20   40 mg/ kg/ day, over a period of 2 weeks in order to determine the vomiting threshold of Bronopol. This was found to be at a dosage of approximately 20 mg/ kg/ day. During the study vomiting occurred within 30 minutes of dosing and no other clinical signs were observed. Macroscopic post mortem examination revealed no abnormalities. In the main study there were no deaths. Vomiting, mainly at 20 mg/ kg/ day, within 0.5 hour of dosing was observed with occasional passage of liquid feces and red stained mucus in isolated animals, both dosed and control. There were no adverse effects on food or water consumption, or on bodyweight. There were no abnormalities of the eye; no macroscopic post mortem abnormalities; or morphological changes or variations from normal in histological tissue examination which could be related to dosage of the test compound. After dosing for 6 weeks, one animal receiving 8 mg/ kg/ day had a serum alkaline phosphatase value approximating to the upper limit of normality of 35 King Armstrong units; after 12 weeks, however, the value was well within normal limits. After dosing for 12 weeks the group mean total white cell count, although within normal limits, was significantly lower in dogs receiving 8 and 20 mg/ kg/ day than in the controls. One animal receiving 4 mg/ kg/ day had a serum glutamicpyruvic transaminase value after 12 weeks which exceeded the upper limit of normality of 50 mU/ ml. Apart from the liver of one dog receiving 20 mg/ kg/ day which was heavier than would normally be expected, all organ weights were within normal limits. However, when expressed as a percentage of bodyweight the mean liver and spleen weights for dogs receiving 20 mg/ kg/ day were significantly heavier than the control values. 5. Chronic toxicity. A 2 year toxicity/ carcinogenicity Bronopol study ( administration via drinking water) in rats showed a NOAEL of   7 mg/ kg/ day and a LEL of < 32 mg/ kg/ day. For more detail see the carcinogenicity summary in Unit B. 2. In a study on potential local and tumorigenic effects from repeated dermal application to mice Bronopol dissolved in 90% acetone/ water was applied to the shaved dorsum of 3 groups of mice ( 52 male and 52 female per group) at 0 ( vehicle control), 0.2%, and 0.5%. Application was at the rate of 0.3 ml per mouse on three days ( Monday, Wednesday, and Friday) in each week for 80 weeks. The results are summarized as follows:   Among some mice treated with 0.5% Bronopol, there was minimal hair loss at the periphery of the shaved area during the first three weeks of treatment.   A marginally inferior survival rate was recorded among male mice, although the prime cause of death VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78466 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices among decedents showed no relation to treatment.   Between weeks 26 and 52, an inferior bodyweight gain was recorded among male mice treated with 0.5% Bronopol, although bodyweight gain over the 80 week treatment period was comparable with that of the controls. Bodyweight gain among other treated mice was not disturbed by treatment.   Food intake and efficiency of food utilization showed no disturbance by treatment.   Macroscopic examination of decedents and mice killed after 80 weeks of treatment, revealed pathology which was common to some animals from control and treated groups.   Microscopic examination of decedents and mice killed at termination revealed changes consistent with the age and strain of mouse employed.   Treatment with Bronopol did not alter the spontaneous tumor profile of the mice. 6. Animal metabolism. Rat and dogs were used in a metabolic study with both oral and cutaneous dosing as follows: Oral Dosing in Rats was by stomach tube with aqueous solutions of [ 14C] Bronopol ( 1 mg/ kg). Oral Dosing Dogs  Beagle dogs were dosed with [ 14C] Bronopol ( 2 mg) mixed with unlabelled Bronopol ( 6   8 mg) as an aqueous solution in gelatin capsules. Cutaneous Dosing Rats and Rabbits  Initially solutions of [ 14C] Bronopol ( 4 mg/ kg) in water, acetone and acetone/ water ( 9: 1, v/ v) were applied to the clipped backs of rats to determine the influence of the vehicle on percutaneous absorption. Acetone was determined to be the preferred application vehicle. In the main tests an acetone solution of [ 14C] Bronopol ( 4.8 mg/ ml) was applied to shaved/ depilated areas of the backs of rats and rabbits at the rates of 0.05 ml per rat and 0.2   0.4 ml per rabbit, the treated areas being occluded with secured polythene. After an oral dose of [ 14C] Bronopol ( 1 mg/ kg) to rats or dogs, the radioactivity was completely absorbed, evenly distributed and rapidly excreted. Excretion was almost complete in 24 hours. During 5 days, rats excreted 83.3% in the urine, 5.8% in the feces ( via the bile) and 8.4% in the expired air; 1.6% was still retained probably by incorporation into pathways of intermediary metabolism of [ 14C] glycerol produced by biotransformation of [ 14C] Bronopol. During 5 days, dogs excreted 81.8% in the urine and 3.1% in the feces. After an oral dose of [ 14C] Bronopol ( 1 mg/ kg), peak blood levels of radioactivity were reached in rats and dogs within 2 hours, and declined with an initial halflife of 4 ± 1 hour. After an oral dose of [ 14C] Bronopol ( 1 mg/ kg) to the rat and the dog, Bronopol and its metabolites were evenly distributed. Only in tissues concerned with excretion did levels of radioactivity exceed those in the blood. When applied to the skin of rats, [ 14C] Bronopol was absorbed to a greater extent from an acetone solvent vehicle than from water: acetone ( 1: 9, v/ v) or water alone. In rats, at least 7 and 15% of an applied dose was percutaneously absorbed during 24 and 96 hours respectively. In rabbits, at least 9% of an applied dose was percutaneously absorbed during 24 hours. Pretreatment of rabbit skin with a depilatory enhanced absorption. Microhistoautoradiographs of rabbit skin showed that [ 14C] Bronopol was mainly localized on the epidermis around the hair follicles. The limited percutaneous absorption of Bronopol may occur through the hair follicles. Five metabolites, which were more polar than Bronopol, were detected in the urine of rats and dogs given an oral dose of [ 14C] Bronopol. One metabolite, shown by comparison of infra red and mass spectra with synthetic material to be 2 nitropropane 1,3 diol, accounted for more than 40% of the administered dose. Unchanged Bronopol, which is unstable in plasma, was not detected. A similar pattern of urinary metabolites of [ 14C] Bronopol was found after cutaneous application as after oral administration of the compound. Further metabolic studies were carried out in male and female rats following single oral doses of [ 14C] Bronopol at 10 and 50 mg/ kg and repeated dosing at 10 mg/ kg/ day with Bronopol for 14 days followed by a single oral dose, 10 mg/ kg of [ 14C] Bronopol. The compound was well absorbed and rapidly excreted mainly via urine. Radioactivity found in the carcass and tissues at 168 hours after dosing accounted for less than 3% of dose. There were no major consistent differences between male and female rats. Bronopol was highly metabolized and intact compound was not detected in the urine. The urinary metabolite chromatographic patterns contained numerous polar metabolites and similar patterns were found for each group. The major metabolite observed was equivalent to desbromo bronopol ( 2 nitro propane 1,3 diol). Extensive metabolism led to radiolabeled onecarbon units excreted as carbon dioxide in expired air. 7. Metabolite toxicology. As determined in the animal metabolism studies in Unit B. 6. numerous polar metabolites were identified in urine from rat and dog. Unchanged 2 bromo 2 nitro 1,3 propanediol was not detected. The major peak in most samples corresponded to desbromobronopol ( debrominated bronopol), i. e. 2 nitropropane 1, 3 diol. This metabolite is not considered of toxicological concern. 8. Endocrine disruption. No specific tests have been conducted with 2 bromo 2 nitro 1,3 propanediol to determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. However, there were no significant findings in other relevant toxicity tests, i. e., teratology and multigeneration reproduction studies, which would suggest that 2 bromo 2 nitro 1,3 propanediol produces effects characteristic of the disruption of endocrine functions.

C. Aggregate Exposure 1. Dietary exposure   i. Food. The proposed use of 2 bromo 2 nitro 1, 3 propanediol as a preservative in end use pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals is not expected to result in any significant additional, dietary exposure, due to the low concentration of 2 bromo 2 nitro 1, 3 propanediol employed in the formulation and the extremely low probability of significant contact by the general public following treatment. 2 bromo 2 nitro 1, 3 propanediol has FDA approval for indirect food contact use as a preservative in adhesives that are components of food packaging or storage materials ( 21 CFR 175.105); as a slimicide for use in pulp and papermaking at a maximum level of 0.6 lb/ ton of dry weight fiber ( 21 CFR 176.300); and paper components in contact with aqueous and fatty foods at a level not to exceed 0.01% by weight of those components ( 21 CFR 176.170). These uses are not expected to result in quantifiable residues of 2 bromo 2 nitro 1, 3 propanediol in the diet. Uses as a preservative in concentrates of agricultural pesticide products also is not expected to be a source of quantifiable residues in food. There are no acute or chronic toxicological concerns associated with the proposed use of 2 bromo 2 nitro 1,3 propanediol as an inert ingredient in concentrates of agricultural pesticide products. An acute dietary risk assessment, therefore, is not required. Chronic exposure to 2 bromo 2 nitropropane 1, 3 diol through food is essentially insignificant. ii. Drinking water. Contamination of drinking water would not be expected to VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78467 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices occur under the proposed use conditions of 2 bromo 2 nitro 1, 3 propanediol as a preservative at very low concentrations in pesticide products intended for applications, principally to growing crops, raw agricultural commodities after harvest, and animals; as either a direct pour on application or as a spray. Neither method of application is expected to contaminate water supplies intended for human consumption. Bronopol is not applied to water and is not used for the disinfection of human or animal drinking water. 2. Non dietary exposure. 2 bromo 2 nitro 1, 3 propanediol is used as an industrial biocide for the prevention of biofouling in areas such as recirculating water in cooling towers and evaporative condensers, air conditioners, air washers and humidifier systems, oil, gas and industrial process water, metal working fluids and paper mill pulp and process water; and for the preservation of surfactants, adhesives, starch, pigment and extender slurries, paints, latex and antifoam emulsions, absorbent clays, water based printing inks and print solutions, water based pesticides and chemical toilet solutions. The margins of exposure ( MOEs) calculated for direct applicators occupationally exposed by either the dermal or inhalation route, based on worst case estimates, revealed there is no level for concern. Estimated exposures to professional painters using paint preserved with 2 bromo 2 nitro 1, 3 propanediol were used as the worst case for estimating secondary occupational exposure risk. MOEs were not exceeded and EPA has concluded that risk associated with secondary exposure are not of concern. 2 bromo 2 nitro 1, 3 propanediol is also used in the preservation of consumer, household and institutional products. Based on the worst case estimate for professional painters chronically exposed to 2 bromo 2 nitro 1, 3 propanediol, EPA has concluded that risk associated with these uses are not of concern. 2 bromo 2 nitro 1, 3 propanediol also is used to preserve pharmaceuticals, cosmetics, and toiletries, which are regulated by FDA. The Cosmetic, Toiletries and Fragrance Association's ( CTFA's) Cosmetic Ingredient Review ( 1980) states that 2 bromo 2 nitro 1,3 propanediol is safe as a cosmetic ingredient at concentrations up to 0.1% except where there is a risk of nitrosamine or nitrosamide formation. Similarly, 2 bromo 2 nitro 1,3 propanediol is listed in Annex VI of the EC Cosmetics directive as an approved preservative for use up to 0.1% except where there is a risk of nitrosamine formation. Based on toxicity data, an aggregate risk or likelihood of the occurrence of an adverse health effect resulting from all routes of exposure to 2 bromo 2 nitro 1, 3 propanediol is not expected.

D. Cumulative Effects There is no reliable information that would indicate or suggest that 2 bromo 2 nitro 1, 3 propanediol has any toxic effects on mammals that would be cumulative with those of any other chemical.

E. Safety Determination 1. U. S. population. The reference dose ( RfD) for 2 bromo 2 nitro 1, 3 propanediol based on the 2 year chronic study ( drinking water) in rats with a NOAEL of 10 mg/ kg/ day and using an uncertainty factor of 100 is calculated to be 0.1 mg/ kg of body weight ( bwt)/ day. The estimated worst case theoretical maximum residue contribution ( TMRC) resulting from this action will be 0.000024 mg/ kg/ bwt/ day for the overall U. S. population and represents 0.024 percent of the RfD. Based upon this information and review of its use, EPA has found that, when used in accordance with good agricultural practice, this ingredient is useful and a tolerance is not necessary to protect the public health. 2. Infants and children. Nothing in the available literature would suggest that infants and children are more sensitive to the effects of 2 bromo 2 nitro 1, 3 propanediol than adults. Exposure of infants to 2 bromo 2 nitro 1, 3 propanediol resulting from its proposed use as an inert ingredient in certain pesticide formulations is expected to be negligible and will not put infants and children at increased risk.

F. International Tolerances BASF Corporation is not aware of the existence of any international tolerances for 2 bromo 2 nitro 1, 3 propanediol.

[ FR Doc. 02   32400 Filed 12   23   02; 8: 45 am]

BILLING CODE 6560   50   S FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Board of Governors of the Federal Reserve System SUMMARY: Background. On June 15, 1984, the Office of Management and Budget ( OMB) delegated to the Board of Governors of the Federal Reserve System ( Board) its approval authority under the Paperwork Reduction Act, as per 5 CFR 1320.16, to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board under conditions set forth in 5 CFR 1320 Appendix A. 1. Board   approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the OMB 83   I's and supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Request for Ccomment on Information Collection Proposal. The following information collection, which is being handled under this delegated authority, has received initial Board approval and is hereby published for comment. At the end of the comment period, the proposed information collection, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under OMB delegated authority. Comments are invited on the following: a. whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility; b. the accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used; c. ways to enhance the quality, utility, and clarity of the information to be collected; and d. ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology. DATES: Comments must be submitted on or before February 24, 2003. ADDRESSES: Comments may be mailed to Ms. Jennifer J. Johnson, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue, N. W., Washington, DC 20551. However, because paper mail in the Washington area and at the Board of Governors is subject to delay, please consider submitting your comments by e mail to regs. comments@ federalreserve. gov, or VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1


[Federal Register: October 25, 2007 (Volume 72, Number 206)]
[Notices]
[Page 60709-60710]
[DOCID:fr25oc07-116]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Cessation of Printing and Hard Copy Distribution of
Advisory Circulars Issued by the Aircraft Certification Service

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION:  Notice of cessation of printing and hard copy distribution of
advisory circulars (AC) issued by the Aircraft Certification Service.

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SUMMARY: This notice announces the cessation of printing and
distribution of advisory circulars issued by the Aircraft Certification
Service. Technology currently allows advisory circulars to be posted to
a public Web site, the Regulator and Guidance Library, http://rgl.faa.gov/
 for easy public access. Because of this easy public

access, the Aircraft Certification Service determined that it is no
longer necessary to print and distribute a hard copy of advisory
circulars as it has done in the past. This will not only make it easier
for the public to have access to advisory circulars issued by the
Aircraft Certification Service almost

immediately upon issuance, it will also result in a cost savings.

DATES: This cessation of printing and distribution of advisory
circulars issued by the Aircraft Certification Service is effective
October 1, 2007.

FOR FURTHER INFORMATION CONTACT: Roberta Katson, Acting Manager,
Planning and Program Management Division, AIR-500, FAA, 800
Independence Avenue, SW., Washington, DC 20591, phone:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    In the past, the only way for the public to see advisory circulars
issued by the Aircraft Certification Service was to receive a printed
copy in the mail. The FAA provided means for anyone in the public to be
placed on a mailing list to receive (or have the opportunity to
purchase, if the advisory circular was larger than a certain size)
copies of these documents. Technology now allows us to make advisory
circulars immediately available to the public upon issuance, via an
easily-accessible Web site, the Regulatory and Guidance Library, http://rgl.faa.gov.
 Because of the ease of access of this Web site, and

because not printing our advisory circulars would be a cost-saving
measure for the government, we decided to cease printing advisory
circulars issued by the Aircraft Certification Service of the FAA,
effective October 1, 2007.

    Issued in Washington, DC on October 15, 2007.
Dorenda D. Baker,
Deputy Director, Aircraft Certification Service.
[FR Doc. 07-5263 Filed 10-24-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: July 16, 2010 (Volume 75, Number 136)]
[Rules and Regulations]
[Page 41379-41381]
[DOCID:fr16jy10-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[Docket EPA-R10-OAR-2010-0432; FRL-9171-4]

Finding of Attainment for PM10 for the Mendenhall
Valley PM10 Nonattainment Area, AK

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA finds that the Mendenhall Valley nonattainment area in
Alaska attained the National Ambient Air Quality Standard (NAAQS) for
particulate matter with an aerodynamic diameter of less than or equal
to a nominal ten micrometers (PM10) as of December 31, 1995.

DATES: This rule is effective on September 14, 2010, without further
notice, unless EPA receives adverse comment by August 16, 2010. If EPA
receives adverse comment, we will publish a timely withdrawal in the
Federal Register informing the public that the rule will not take
effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2010-0432, by any of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Mail: Steve Body, EPA Region 10, Office of Air, Waste and
Toxics (AWT-107), 1200 Sixth Avenue, Suite 900, Seattle, WA 98101.
     Hand Delivery/Courier: EPA Region 10, 1200 Sixth Avenue,
Suite 900, Seattle, WA 98101. Attention: Steve Body, Office of Air,
Waste and Toxics, AWT-107. Such deliveries are only accepted during
normal hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R10-OAR-
2010-0432. 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.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy. Publicly available docket
materials are available either electronically in http://
www.regulations.gov or in hard copy during normal business hours at the
Office of Air, Waste and Toxics, EPA Region 10, 1200 Sixth Avenue,
Suite 900, Seattle WA 98101.

FOR FURTHER INFORMATION CONTACT: Steve Body at telephone number: (206)
553-0782, e-mail address<EMAIL_ADDRESS>or the above EPA, Region
10 address.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we'',
``us'' or ``our'' are used, we mean EPA. Information is organized as
follows:

Table of Contents

I. Background
    A. PM10 NAAQS
    B. Designation and Classification of PM10
nonattainment areas
    C. How does EPA make attainment determinations?
    D. What is the attainment date for the Mendenhall
PM10 nonattainment area?
    E. What PM10 planning has occurred for the Mendenhall
Valley PM10 nonattainment area?
II. EPA's Analysis
    A. What does the air quality data show as of the December 31,
1995 attainment date?
    B. Does more recent air quality data also show attainment?
III. Statutory and Executive Order Reviews

I. Background

A. PM10 NAAQS

    The NAAQS are levels for certain ambient air pollutants set by EPA
to protect public health and welfare. PM10, or particulate
matter with an aerodynamic diameter less than or equal to a nominal 10
micrometers, is among the ambient air pollutants for which EPA has
established health-based standards. On July 1, 1987 (52 FR 24634), EPA
promulgated two primary standards for PM10: a 24-hour
standard of 150 micrograms per cubic meter ([mu]g/m\3\) and an annual
PM10 standard of 50 [mu]g/m\3\. EPA also promulgated
secondary PM10 standards that were identical to the primary
standards.
    Effective December 18, 2006, EPA revoked the annual PM10
standard but retained the 24-hour PM10 standard. 71 FR 61144
(October 17, 2006). The 24-hour PM10 standard is attained
when the expected number of days per calendar year with a 24-hour
concentration in excess of the standard, as determined in accordance
with 40 CFR part 50, appendix K, is equal to or less than one.\1\ 40
CFR 50.6 and 40 CFR part 50, appendix K.
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    \1\ An exceedance is defined as a daily value that is above the
level of the 24-hour standard (150 [mu]g/m\3\) after rounding to the
nearest 10 [mu]g/m\3\ (i.e. values ending in 5 or greater are to be
rounded up). Thus, a recorded value of 154 [mu]g/m\3\ would not be
an exceedance since it would be rounded to 150[mu]/m\3\ whereas a
recorded value of 155 [mu]g/m\3\ would be an exceedance since it
would be rounded to 160 [mu]/m\3\. See 40 CFR part 50, appendix K,
section 1.0.
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B. Designation and Classification of PM10 Nonattainment Areas

    Areas meeting the requirements of section 107(d)(4)(B) of the Clean
Air Act (CAA or the Act) were designated nonattainment for
PM10 by operation of law and classified ''moderate'' upon
enactment of the 1990 Clean Air Act Amendments. See generally 42 U.S.C.
7407(d)(4)(B). These areas included all former Group I PM10
planning areas identified on August 7, 1987 (52 FR 29383), as further
clarified on October 31, 1990 (55 FR 45799), and any other areas
violating the NAAQS for PM10 prior to January 1, 1989. A
Federal Register notice announcing the areas

designated nonattainment for PM10 upon enactment of the 1990
Amendments, known as ``initial'' PM10 nonattainment areas,
was published on March 15, 1991 (56 FR 11101) and a subsequent Federal
Register document correcting the description of some of these areas was
published on August 8, 1991 (56 FR 37654). The Mendenhall Valley
PM10 nonattainment area was one of these initial moderate
PM10 nonattainment areas.
    All initial moderate PM10 nonattainment areas had the
same applicable attainment date of December 31, 1994. Section 188(d)
provides the Administrator the authority to grant up to two one-year
extensions to the attainment date provided certain requirements are
met. States containing initial moderate PM10 nonattainment
areas were required to develop and submit to EPA by November 15, 1991,
a state implementation plan (SIP) revision providing implementation of
reasonably available control measures (RACM), including reasonably
available control technology (RACT), and a demonstration of whether
attainment of the PM10 NAAQS by the December 31, 1994
attainment date was practicable. See section 189(a).

C. How does EPA make attainment determinations?

    All PM10 nonattainment areas are initially classified
``moderate'' by operation of law when they are designated
nonattainment. See section 188(a). Pursuant to sections 179(c) and
188(b)(2) of the Act, we have the responsibility of determining within
six months of the applicable attainment date whether, based on air
quality data, PM10 nonattainment areas attained the
PM10 NAAQS by that date. Determinations under section
179(c)(1) of the Act are to be based upon the area's ``air quality as
of the attainment date.'' Section 188(b)(2) is consistent with this
requirement.
    Generally, we determine whether an area's air quality is meeting
the PM10 NAAQS for purposes of section 179(c)(1) and
188(b)(2) based upon data gathered at established state and local air
monitoring stations (SLAMS) and national air monitoring stations (NAMS)
and recently renamed National Core (NCore) monitoring stations in the
nonattainment areas and entered into the EPA's national data base, now
called Air Quality System (AQS). Data entered into the AQS has been
determined to meet Federal monitoring requirements (see 40 CFR 50.6, 40
CFR part 50, appendix J, 40 CFR part 53, 40 CFR part 58, appendix A)
and may be used to determine the attainment status of areas. We will
also consider air quality data from other air monitoring stations in
the nonattainment area provided that the stations meet the Federal
monitoring requirements for SLAMS. All data are reviewed to determine
the area's air quality status in accordance with our guidance at 40 CFR
part 50, appendix K.
    Attainment of the 24-hour standard is determined by calculating the
expected number of days in a year with PM10 concentrations
greater than 150 ug/m3. The 24-hour standard is attained when the
expected number of days with levels above 150 ug/m3 (averaged over a
three year period) is less than or equal to one. Three consecutive
years of air quality data are generally required to show attainment of
the 24-hour standards for PM10. See 40 CFR part 50 and
appendix K.

D. What is the attainment date for the Mendenhall Valley
PM10 nonattainment area?

    The original attainment date for the Mendenhall Valley
PM10 nonattainment area was December 31, 1994. On September
12, 1994, (60 FR 47276) the attainment date was later extended to
December 31, 1995, under the authority of section 188(d) of the Act.

E. What PM10 Planning has occurred for the Mendenhall Valley PM10
nonattainment area?

    After the Mendenhall Valley PM10 nonattainment area was
designated nonattainment for PM10, the Alaska Department of
Environmental Conservation (ADEC), began in the early 1990s to prepare
the technical elements needed to bring the area into attainment and
meet the planning requirements of title I of the CAA. Based on these
technical products ADEC developed and implemented control measures on
PM10 sources in the Mendenhall Valley PM10
nonattainment area. The State submitted these control measures to EPA
on June 22, 1993, as a moderate PM10 nonattainment SIP
revision under section 189(a) of the Act. The control measures
submitted by the State include a comprehensive residential wood
combustion program and controls on fugitive road dust. EPA took final
action to approve the State's moderate PM10 SIP on March 24,
1994, (59 FR 13885).

II. EPA's Analysis

A. What does the air quality data show as of the December 31, 1995
attainment date?

    Whether an area has attained the PM10 NAAQS is based
exclusively upon measured air quality levels over the three calendar
years See 40 CFR part 50 appendix K. For an area with a December 31,
1995, attainment date, data reported for calendar years 1993, 1994 and
1995 is considered. EPA also considered air quality data reported for
the period subsequent to the attainment date to the present to
demonstrate the area continued to attain the PM10 NAAQS.
    The State of Alaska operated two PM10 SLAMS monitoring
sites in the Mendenhall Valley PM10 nonattainment area
during 1992 through 1995: Floyd Dryden High School and Trio Street.
Both sites meet Federal siting requirements and are appropriate for
monitoring the area's compliance with the PM10 NAAQS. (See
EPA's letters approving Alaska's annual network review.) The Trio
Street site ceased operation in 1997. The Floyd Dryden Middle School
site continued operation through 2009.
Floyd Dryden Middle School Site
    The Floyd Dryden site recorded two values above the level of the 24
hour PM10 NAAQS (exceedances) in February 1992. These values were
flagged by ADEC as exceptional events due to high winds, but AQS does
not show that R10 concurred on these flags. Thus, these two daily
values are included in the expected exceedance calculations. Outside of
these two exceedances there have been no other exceedances of the daily
PM10 standard at the Floyd Dryden Middle School site from
February 1992 through December 31, 2009.
    There were a number of years for which the number of reported daily
values did not meet the 75% data completeness criteria required for
making attainment determinations: 1998, 2000, 2003, 2008, and 2009.
Therefore an affirmative attainment determination can only be made for
a subset of these years; 1992-94, 1993-95, 1994-96, 1995-97, 2004-06,
and 2005-07. The 1993-1995 expected exceedance rate is 0.0 which
likewise demonstrates attainment with the NAAQS by the attainment date.
Trio Street Site
    The Trio Street site recorded five PM10 exceedances in
1992 and three in 1993. Of these eight total exceedances, only the four
recorded in the first quarter 1992 were flagged by ADEC as high wind
exceptional events. The AQS does not show that Region 10 concurred on
these high wind events and therefore the data cannot be excluded from
expected exceedance calculations. There were no exceedances from 1994
through 1997 when the site ceased operation. For the time period of

January 1, 1992 to June 30, 1997, the Trio Street site met the 75%
quarterly data completeness requirement. Thus, there is sufficient data
to make an attainment determination. The expected exceedance
calculation for years 1993-95 was 1.0, which demonstrates attainment.
An expected exceedance rate of greater than 1.0 would be a violation of
the NAAQS.

B. Does more recent air quality data also show attainment?

    Although the attainment date for the Mendenhall Valley
PM10 nonattainment area is December 31, 1995, and the air
quality data used to judge attainment by that date includes all data
collected in calendar years 1993, 1994, and 1995, EPA has also reviewed
the air quality data collected at the State monitoring sites from
January 1996 through December 2009. As discussed above, there have been
no exceedances recorded at the Floyd Dryden site since 1992 and no
exceedances recorded at the Trio Street site from 1994 through 1997,
when it ceased operation. Thus, the area continues to be in compliance
with the 24 hour PM10 NAAQS during this period.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 14, 2010. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the proposed
rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, Intergovernmental
relations, Particulate matter, Reporting and recordkeeping
requirements.

    Dated: June 22, 2010.
Dennis J. McLerran,
Regional Administrator, EPA, Region 10.
[FR Doc. 2010-17417 Filed 7-15-10; 8:45 am]
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[Federal Register Volume 78, Number 225 (Thursday, November 21, 2013)]
[Notices]
[Page 69925]
[FR Doc No: 2013-28025]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Order of Suspension of Trading; In the Matter of HouseRaising,
Inc., iElement Corporation, InforMedix Holdings, Inc., Nortia Capital
Partners, Inc., and PC Universe, Inc.

November 19, 2013.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
HouseRaising, Inc. because it has not filed any periodic reports since
the period ended September 30, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
iElement Corporation because it has not filed any periodic reports
since the period ended December 31, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
InforMedix Holdings, Inc. because it has not filed any periodic reports
since the period ended September 30, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Nortia Capital Partners, Inc. because it has not filed any periodic
reports since the period ended January 31, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
PC Universe, Inc. because it has not filed any periodic reports since
the period ended June 30, 2009.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EST on November 19, 2013, through 11:59
p.m. EST on December 3, 2013.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-28025 Filed 11-19-13; 11:15 am]
BILLING CODE 8011-01-P