58341 Federal Register / Vol. 68, No. 196 / Thursday, October 9, 2003 / Notices mark information they consider confidential. EPA will make final confidentiality determinations in accordance with regulations in 40 CFR part 2, subpart B. Although the selections will be announced at the national level, Watershed Initiative grants will be awarded and managed by the respective EPA Regional Offices. Selected nominees may be asked to modify objectives, workplans, or budgets prior to final approval of the grant award. The exact amount of funds to be awarded, the final scope of activities, the duration of the projects, and specific role of the EPA Regional project coordinator will be determined in the pre award negotiations between the selected nominee and EPA. The designated EPA Regional Contact listed in section IV. C will be available to provide additional guidance in completing the grant application, and other necessary forms, and answering any questions. EPA will also work with the applicant to comply with the Intergovernmental review requirements of Executive Order 12372 and 40 CFR part 29. EPA reserves the right reject all proposals and make no awards.

B. Project Implementation and Management Project monitoring and reporting requirements can be found in 40 CFR 30.50   30.54, 40 CFR 31.40   31.45 and 40 CFR 40.160. In general, grantees are responsible for managing the day to day operations and activities supported by the grant to assure compliance with applicable Federal requirements, and for ensuring that established milestones and performance goals are being achieved. Performance reports and financial reports must be submitted quarterly and are due 30 days after the reporting period. The final report is due 90 days after the grant has expired. Grant managers should consult, and work closely with, their Regional contact person throughout the award period. Certain quality assurance and/ or quality control ( QA/ QC) and peer review requirements are applicable to the collection of environmental data. Applicants should allow sufficient time and resources for this process in their proposed projects. Environmental data are any measurements or information that describe environmental processes, location, or condition; ecological or health effects and consequences; or the performance of environmental technology. Environmental data also include information collected directly from measurements, produced from models, and obtained from other sources such as data bases or published literature. Regulations pertaining to QA/ QC requirements can be found in 40 CFR 30.54 and 31.45. Additional guidance can be found at http:// www. epa. gov/ quality/ qa_ docs. html# noeparqt.

Dated: September 29, 2003. G. Tracy Mehan, Assistant Administrator for Water. [ FR Doc. 03   25401 Filed 10   8   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OPPT   2003   0057; FRL   7330   5]

Certain New Chemicals; Receipt and Status Information AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: Section 5 of the Toxic Substances Control Act ( TSCA) requires any person who intends to manufacture ( defined by statute to include import) a new chemical ( i. e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Under sections 5( d)( 2) and 5( d)( 3) of TSCA, EPA is required to publish a notice of receipt of a premanufacture notice ( PMN) or an application for a test marketing exemption ( TME), and to publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from August 18, 2003 to September 5, 2003, consists of the PMNs pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period. DATES: Comments identified by the docket ID number OPPT   2003   0057 and the specific PMN number or TME number, must be received on or before November 10, 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: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics ( 7408M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 554   1404; e mail address: TSCAHotline epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitter of the premanufacture notices addressed in the action. 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 OPPT   2003   0057. 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 EPA Docket Center, Rm. B102 Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is ( 202) 566   1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is ( 202) 566   0280. 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 VerDate jul< 14> 2003 17: 04 Oct 08, 2003 Jkt 203001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09OCN1. SGM 09OCN1 RECEIVED OPPT NCIC 2003 October 9 7: 47AM OPPT 2003 0057 0001 58342 Federal Register / Vol. 68, No. 196 / Thursday, October 9, 2003 / Notices 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. 1. 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 and specific PMN number or TME 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 OPPT   2003   0057. 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 oppt. ncic@ epa. gov, Attention: Docket ID Number OPPT   2003   0057 and PMN Number or TME Number. 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 email 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: Document Control Office ( 7407M), Office of Pollution Prevention and Toxics ( OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. By hand delivery or courier. Deliver your comments to: OPPT Document Control Office ( DCO) in EPA East Building Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number OPPT   2003   0057 and PMN Number or TME Number. The DCO is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is ( 202) 564   8930.

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 VerDate jul< 14> 2003 17: 04 Oct 08, 2003 Jkt 203001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09OCN1. SGM 09OCN1 58343 Federal Register / Vol. 68, No. 196 / Thursday, October 9, 2003 / Notices notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

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

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action and the specific PMN number you are commenting on in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Why is EPA Taking this Action?

Section 5 of TSCA requires any person who intends to manufacture ( defined by statute to include import) a new chemical ( i. e., a chemical not on the TSCA Inventory to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Under sections 5( d)( 2) and 5( d)( 3) of TSCA, EPA is required to publish a notice of receipt of a PMN or an application for a TME and to publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from August 18, 2003 to September 5, 2003, consists of the PMNs pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period.

III. Receipt and Status Report for PMNs This status report identifies the PMNs pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period. If you are interested in information that is not included in the following tables, you may contact EPA as described in Unit II. to access additional non CBI information that may be available. In Table I of this unit, EPA provides the following information ( to the extent that such information is not claimed as CBI) on the PMNs received by EPA during this period: the EPA case number assigned to the PMN; the date the PMN was received by EPA; the projected end date for EPA's review of the PMN; the submitting manufacturer; the potential uses identified by the manufacturer in the PMN; and the chemical identity.

I. 28 PREMANUFACTURE NOTICES RECEIVED FROM: 08/ 18/ 03 TO 09/ 05/ 03 Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical P   03   0773 08/ 18/ 03 11/ 15/ 03 CBI ( G) Industrial intermediate which is compounded with pigments and binders before being coated onto paper for carbonless copy paper applications. ( G) Zincated resin system P   03   0774 08/ 19/ 03 11/ 16/ 03 PPG Industries, Inc. ( G) Coating with open use ( G) Cationic acrylic copolymer P   03   0775 08/ 19/ 03 11/ 16/ 03 PPG Industries, Inc. ( G) Coating with open use ( G) Cationic acrylic copolymer P   03   0776 08/ 19/ 03 11/ 16/ 03 PPG Industries, Inc. ( G) Coating with open use ( G) Cationic acrylic copolymer P   03   0777 08/ 19/ 03 11/ 16/ 03 CBI ( G) Emulsifier ( G) Polyalkyl carboxylic acid polyol esters P   03   0778 08/ 20/ 03 11/ 17/ 03 The Dow Chemical Company ( G) Additive for plastics ( G) Phenol, polymer with formaldehyde and phenol derivative P   03   0779 08/ 20/ 03 11/ 17/ 03 CBI ( G) Intermediate used in closed processes ( S) 3 oxatricyclo[ <IP_ADDRESS>,4] octane, 2,7,7 trimethyl, ( 1r, 2r, 4s, 6r) P   03   0780 08/ 20/ 03 11/ 17/ 03 CBI ( G) Dehydration agent ( G) Polyester P   03   0781 08/ 22/ 03 11/ 19/ 03 Petroferm Inc. ( S) Slip and leveling additive to uvand eb cured inks, paints and coatings oligomer in the manufacture of polymeric materials ( G) Allyl ethoxylate methacrylate P   03   0782 08/ 22/ 03 11/ 19/ 03 Petroferm Inc. ( S) Slip and leveling additive to uvand eb cured inks, paints and coatings oligomer in the manufacture of polymeric materials ( G) Combed silicone acrylate P   03   0783 08/ 22/ 03 11/ 19/ 03 Petroferm Inc. ( S) Slip and leveling additive to uvand eb cured inks, paints and coatings oligomer in the manufacture of polymeric materials ( G) Combed silicone methacrylate P   03   0784 08/ 22/ 03 11/ 19/ 03 Petroferm Inc. ( S) Slip and leveling additive to uvand eb cured inks, paints and coatings oligomer in the manufacture of polymeric materials ( G) Linear silicone methacrylate P   03   0785 08/ 22/ 03 11/ 19/ 03 CBI ( G) Defoamer ( G) Propoxylated fatty alcohol esters P   03   0786 08/ 22/ 03 11/ 19/ 03 Ashland Inc., Environmental Health and Safety ( G) Lamination adhesive ( G) Polyurethane dispersion  lamination adhesive P   03   0787 08/ 22/ 03 11/ 19/ 03 Crompton Corporation ( S) By product of erucamide production to be recycled ( S) 13 docosenoic acid, potassium salt, ( 13z)

VerDate jul< 14> 2003 17: 04 Oct 08, 2003 Jkt 203001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09OCN1. SGM 09OCN1 58344 Federal Register / Vol. 68, No. 196 / Thursday, October 9, 2003 / Notices I. 28 PREMANUFACTURE NOTICES RECEIVED FROM: 08/ 18/ 03 TO 09/ 05/ 03   Continued Case No. Received Date Projected Notice End Date Manufacturer/ Importer Use Chemical P   03   0788 08/ 22/ 03 11/ 19/ 03 Crompton Corporation ( S) By product of amide production to be recycled ( S) Docosanoic acid, potassium salt P   03   0789 08/ 22/ 03 11/ 19/ 03 CBI ( S) Polymerisable photoinitiator for uv curable coatings ( G) Derivatized butyl ester photoinitiator P   03   0790 08/ 25/ 03 11/ 22/ 03 CBI ( G) Component of foam ( G) Polyester polyol P   03   0791 08/ 25/ 03 11/ 22/ 03 E. I. Du Pont De Nemours and Company Inc. ( dupont) ( G) Molding resin ( G) Ethylene interpolymer P   03   0792 08/ 25/ 03 11/ 22/ 03 Dupont Textiles and Interiors ( S) Emulsifier, corrosion inhibitor, and lubricant for metalworking fluid ( S) Cyclododecane, oxidized, byproducts from, acidified, oil phase P   03   0793 08/ 26/ 03 11/ 23/ 03 UBE America Inc. ( S) External donor for olefin polymerization ( S) Silanamine, 1,1,1 triethoxy n, ndiethyl P   03   0794 08/ 29/ 03 11/ 26/ 03 BASF Corporation Perfomance Chemicals ( G) Oxidation catalyst ( S) Alanine, n, n bis ( carboxymethyl), iron sodium complexes P   03   0795 08/ 29/ 03 11/ 26/ 03 CIBA Specialty Chemicals Corporation ( S) Photo cure for imaging / electronics industry ( G) Organo titanium complex P   03   0796 08/ 29/ 03 11/ 26/ 03 CBI ( G) Raw material ( G) Halogenated heteropolycycle P   03   0797 08/ 29/ 03 11/ 26/ 03 CBI ( G) Raw material ( G) Halogenated heteropolycycle P   03   0798 08/ 29/ 03 11/ 26/ 03 CBI ( G) Synthetic industrial lubricant for contained use. ( G) Pentaerythritol, mixed esters with straight and branched fatty acids P   03   0799 08/ 29/ 03 11/ 26/ 03 CBI ( G) Synthetic industrial lubricant for contained use. ( G) Dipentaerythritol, mixed esters with straight and branched fatty acids P   03   0800 08/ 29/ 03 11/ 26/ 03 CBI ( G) Synthetic industrial lubricant for contained use ( G) Pentaerythritol, mixed esters with straight chain and branched fatty acids P   03   0801 08/ 29/ 03 11/ 26/ 03 CBI ( G) Synthetic industrial lubricant for contained use ( G) Dipentaerythritol, mixed esters with straight chain and branched fatty acids In Table II of this unit, EPA provides the following information ( to the extent that such information is not claimed as CBI) on the Notices of Commencement to manufacture received:

II. 17 NOTICES OF COMMENCEMENT FROM: 08/ 18/ 03 TO 09/ 05/ 03 Case No. Received Date Commencement/ Import Date Chemical P   00   0552 08/ 25/ 03 07/ 26/ 03 ( G) Salicylic acid, zirconium salt P   01   0443 08/ 26/ 03 08/ 07/ 03 ( G) Copolymer of polyoxyethylene allyl methyl ether P   01   0813 08/ 22/ 03 07/ 29/ 03 ( G) Cerium based organic compound P   02   0574 08/ 22/ 03 08/ 16/ 03 ( G) Amine functional epoxy based resin salted with an organic acid P   02   0638 08/ 25/ 03 07/ 13/ 03 ( G) Hexanedioic acid, polymer with 2,2 dimethyl 1,3 propanediol, 1,6 hexanediol, hexanedioic acid amide derivative, 3 hydroxy 2( hydroxymethyl) 2 methylpropanoic acid and 1,1  methylenebis[ 4 isocyanatocyclohexane], compound with nu, nu diethylethaneamine P   02   0946 08/ 19/ 03 07/ 22/ 03 ( G) Substituted benzoic acid, alkali salt P   02   0992 08/ 26/ 03 07/ 25/ 03 ( G) Ethylene oxide propylene oxide copolymer allyl alkyl ether P   03   0067 08/ 25/ 03 07/ 31/ 03 ( G) Fluoroalkene substitutedalkene polymer P   03   0078 08/ 20/ 03 07/ 27/ 03 ( G) Sulphonated azo dye P   03   0291 08/ 25/ 03 08/ 11/ 03 ( G) Corn by product P   03   0292 08/ 25/ 03 08/ 13/ 03 ( G) ThermoChemical mechanical processed maize fiber P   03   0325 08/ 20/ 03 08/ 07/ 03 ( S) Oxazolidine, 3,3  methylenebis[ 5 methyl P   03   0398 08/ 27/ 03 06/ 09/ 03 ( G) Modified hydrocarbylpolysilicate P   03   0410 08/ 25/ 03 08/ 15/ 03 ( G) Styrene acrylic copolymer P   03   0462 08/ 21/ 03 08/ 01/ 03 ( G) Bisphenol a type epoxy resin, salt P   03   0474 08/ 20/ 03 08/ 11/ 03 ( G) Hydrophobically modified acetylenic glycol P   99   1225 08/ 26/ 03 07/ 22/ 03 ( G) Acrylic copolymer resin VerDate jul< 14> 2003 17: 04 Oct 08, 2003 Jkt 203001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09OCN1. SGM 09OCN1 58345 Federal Register / Vol. 68, No. 196 / Thursday, October 9, 2003 / Notices List of Subjects Environmental protection, Chemicals, Premanufacture notices Dated: October 2, 2003. Sandra Wilkins, Acting Director, Information Management Division, Office of Pollution Prevention and Toxics. [ FR Doc. 03   25638 Filed 10   8   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ FRL   7572   1]

New York State Prohibition on Marine Discharges of Vessel Sewage; Final Affirmative Determination Notice is hereby given that EPA has made a final affirmative determination regarding the petition received from the State of New York on April 29, 1999 requesting a determination by the Regional Administrator, Environmental Protection Agency ( EPA), pursuant to Section 312( f)( 3) of Public Law 92   500, as amended by Public Law 95   217 and Public Law 100   4 ( the Clean Water Act), that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available for the waters of the Hudson River and its tributaries including, but not limited to, Rondout Creek, Esopus Creek and Catskill Creek. This petition was made by the New York State Department of State, in conjunction with the New York State Department of Environmental Conservation. New York State certified in the petition a need for greater protection and enhancement. The certification states that the discharge of vessel waste often contain chemical additives such as formaldehyde, phenols and chlorine. These wastes increase loadings of nutrients, pathogens and chemical loading particularly in shallow, poorly flushed waterbodies, and may adversely affect water quality, sensitive and important resources, and uses of these waters. The Hudson River provides habitat for fish and wildlife species. Congress has designated the Hudson River as a National Heritage Area under the purview of the National Park Service, and in 1998, the Hudson River was designated an American Heritage River. Upon receipt of this final affirmative determination, the State of New York will completely prohibit the discharge of sewage, whether treated or not, from any vessel, with the exception of commercial vessels that are greater than 225 feet in overall length or are greater than 20 feet in draft, on the Hudson River in the area north of the Battery in Manhattan, New York and south of Federal Dam in Troy, New York in accordance with Section 312( f)( 3) of the Clean Water Act and 40 CFR 140.4( a). For vessels that are greater than 225 feet in overall length or are greater than 20 feet in draft, the prohibition will be applicable one year from the date of publication in the Federal Register. Previously, EPA established on December 13, 1995 two No Discharge Areas ( NDAs) to protect drinking water intake zones. Zone 1 is bounded by the northern confluence of the Mohawk River on the south and Lock 2 on the north. It is approximately 8 miles long. Zone 2 is bounded on the south by the Village of Roseton on the western shore and bounded on the north by the southern end of Houghtaling Island. Zone 2 is approximately 60 miles long. The southern boundary of the proposed NDA in this application would begin at the Battery in Manhattan, New York and the northern boundary would be the Federal Dam in Troy, New York. This area includes waters up to the New Jersey New York boundary and does not include waters in New Jersey. The area proposed by the State of New York is 153 miles long and encompasses approximately 81,000 acres of tidal waters and wetlands. On October 24, 2000, EPA published a Receipt of Petition and Tentative Determination and accepted comments from the public for a thirty ( 30) day period. The comment period was extended until December 22, 2000 at the request of one of the commenters. EPA received letters from the following individuals: 1. Harold Gorman, 2332 Fort Lyon Drive, Stanton, VA 2. Edward V. Weber, 60 Round Hill Road, Poughkeepsie, NY 12603   5125 3. Ned Sullivan, Executive Director, Scenic Hudson, Inc., 9 Vassar Street, Poughkeepsie, NY 12601 4. Andrew J. Spano, County Executive, Westchester County, Michaelian Office Building, White Plains, NY 10601 5. Manna Jo Greene, Environmental Director, Clearwater, Inc., 112 Little Market Street, Poughkeepsie, NY 12601 6. Joseph P. Gehegan, Jr., Vice President, Spentonbush/ Red Star Companies, P. O. Box 392, Brooklyn, NY 11231 7. Joseph Tesoriero, Safety Director, McAllister Towing and Transportation Company, Inc., 17 Battery Place, New York, NY 10004   1260 8. Kenneth L. Peterson, Jr., Port Captain, Reinauer Transportation Companies, 1983 Richmond Terrace, Staten Island, NY 10302 9. Robert J. Hughes, Jr., Hughes Marine Firms, Raritan Plaza I, Raritan Center, Edison, NJ 08837 10. John C. Tobin, New York State Waterways Association, Inc., 174 Washington Avenue, Albany, NY 12210 11. Kevin A. Nugent, Vice President, Bouchard Transportation Co., Inc., 77 Newbridge Road, Hicksville, NY 11801 12. Richard M. Larrabee, Director, Port Commerce Dept., The Port Authority of New York & New Jersey, One World Trade Center, 34S, New York, NY 10048   0682 13. Linda O'Leary, Vice President   Atlantic Coast Region, American Waterways Operators, 241 Water Street, New York, NY 10038 One commenter expressed confusion over the boundaries of the Hudson River NDA. His confusion was caused by the statement that some vessel operators while docked at the Brooklyn Naval Yard have their holding tanks pumped out by waste haulers. Since the Brooklyn Naval Yard is on the East River, he asked whether the prohibition included the East River. It does not include the East River, but boaters may choose to use pumpout facilities located outside of the NDA because the facilities are more convenient for them. For example, a boater who keeps his boat in a Staten Island marina may choose to use the pumpout at his home marina because it is convenient. The southern boundary of the proposed No Discharge Area ( NDA) in this application would begin at the Battery in Manhattan, New York and the northern boundary would be the Federal Dam in Troy, New York. This area includes waters up to the New Jersey New York boundary and does not include waters in New Jersey. It does not include the East River, the Harlem River, the Long Island Sound nor the Raritan Bay. No change to the determination is necessary based on this comment. Three commenters expressed their support for the complete prohibition of the discharge of sewage from vessels. They believe that this determination is an important step in maintaining the vitality of the Hudson River. No change to the determination is necessary based on these comments. One commenter compared the prohibition to a `` chamber pot'' approach and questioned whether making waste disposal more difficult for boaters effectively eliminates sewage. The commenter stated that marine sanitation devices ( MSDs) must be VerDate jul< 14> 2003 17: 04 Oct 08, 2003 Jkt 203001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09OCN1. SGM 09OCN1


For EPA-Approved Verifiers Only:  The HVAC Quality Installation Contractor Checklist must be completed by the HVAC contractor.  Please review the checklist using the form below to help ensure that the equipment was installed to design specifications.

Home Address:	City:	State:

Inspection Guidelines	Must Correct	Verifier Approved	N/A

1.  Review of HVAC Quality Installation Contractor Checklist

1.1.   Checklist completed in its entirety	(	(	(

1.2    Compliance with Manual J, S, D, and T or equivalents indicated	( (	(

1.3    Required outdoor/indoor temperature and infiltration rate

         assumptions used to complete Manual J calculations	(	(	(

1.4    ARI Certificate attached 	(	(	(

1.5    Reported equipment capacity field values within 5% of design values	(	(	(

1.6    Reported air flow field values within 5% of design values	(	(	(

1.7    Reported duct static pressure field values within 5% of design values	(	(	(

1.8    Reported design fan motor type the same as the field fan motor type	(	(	(

1.9    Reported fan speed field values within 5% of design values	(	(	(

1.10  Reported refrigerant charge and metering device field types the

         same as design types	(	(	(

1.11  For Non-Lennox TXV devices, reported sub-cooling temperature

         deviation within +/- 3 degrees F of goal	(	(	(

1.12  For Lennox TXV devices, reported approach temperature deviation

         +/- 1 degrees F of goal	(	(	(

1.13  For Fixed Orifice devices, reported superheat temperature deviation

        +/- 5 degrees F of goal	(	(	(

2. Duct Quality Installation

2.1   Connections and routing of ductwork completed without kinks or

        bends > 90°  1	(	(	(

2.2   No excess coiled or looped flexible ductwork 1	(	(	(

2.3   No compression of flexible ductwork 1	(	(	(

2.4   Flexible ducts supported at intervals as recommended by

        manufacturer but at a distance not > 5 ft. and with maximum sag of

        0.5 in. per ft. of spacing between supports 1	(	(	(

2.5   All connections to trunk ducts in unconditioned space insulated	( (	(

2.6   Building cavities not used as return ducts	(	(	(

2.7   Bedrooms pressure-balanced such that 1 sq. in. of opening is

       provided per 1 CFM of supply air. Dedicated return ducts, transfer

       grills, and/or jump ducts may be used to meet this requirement.	( (	(

Verifier Name: 	 Inspection of Checklist Date:

Verifier Signature:	 Verifier Company Name:

1. Scope of work applies to all HVAC and ventilation ductwork.

OMB Control No. xxxx-xxxx

ENERGY STAR Qualified Homes

HVAC Quality Installation Verifier Checklist

EPA Form 5900-174

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responsible for these mechanisms, and how much would they cost?

G. Other Considerations

    To aid in its consideration regarding development of a nicotine
tobacco product standard, FDA is seeking data, research results, and
other information regarding the following:
    1. What data may be helpful to assess the universe of tobacco
products that are currently available to consumers and their relevant
characteristics, such as nicotine levels? How can available sources of
information, such as manufacturer registrations and/or product listings
with FDA, be used in this assessment?
    2. How should potential consumer surplus or utility loss from the
removal of nicotine in cigarettes be considered, given the availability
of other sources of nicotine such as ENDS and the continued
availability of combustible tobacco products?
    3. What sources of information could be used to estimate the change
in demand for VLNC cigarettes? What factors should we consider in
estimating the changes in demand for other tobacco products?
    4. What factors should be considered in estimating changes in
experimentation and initiation that may occur as a result of a
potential nicotine tobacco product standard?
    5. In what ways might a change in nicotine levels in cigarettes
spur innovation in the market for both combusted and noncombusted
tobacco products?
    6. What factors should be considered in estimating the impacts of
externalities that might exist for VLNC cigarettes, such as secondhand
smoke, litter, and pollution? How could the impact of externalities for
VLNC cigarettes be compared to the impacts from NNC cigarettes?
    7. What factors should we consider in estimating the impact of
changes in demand for other tobacco products?
    8. If FDA were to finalize a nicotine tobacco product standard,
what might be the costs to current smokers?
    9. Are there any other relevant comments or information that would
be helpful for FDA to consider in analyzing the economic impacts of a
proposed nicotine tobacco product standard?

V. Potential Public Health Benefits of Preventing Initiation to Regular
Use and Increasing Cessation

    If FDA were to issue a proposed tobacco product standard setting a
maximum nicotine level, FDA would provide an analysis explaining how
the proposed rule would be appropriate for the protection of the public
health (section 907(a)(3)(A) of the FD&C Act). For the purposes of this
ANPRM, this section briefly describes the potential public health
benefits FDA believes could result from the increased cessation and
decreased initiation to regular use that FDA expects could occur if
cigarettes and possibly some other combusted tobacco products were
minimally addictive or nonaddictive. It also references findings from a

population-based simulation model that quantified the potential public
health impact of enacting a regulation lowering nicotine levels in
cigarettes and some other combusted tobacco products to minimally
addictive levels, utilizing inputs derived from empirical evidence and
expert opinion. We are seeking public comment regarding the inputs that
should be used for modeling the impact of a nicotine tobacco product
standard.

A. Smoking Cessation Would Lead to Substantial Public Health Benefits
for People of All Ages

    Significant declines in the deaths caused by the use of combusted
tobacco products can be achieved by reducing the prevalence of smoking
cigarettes and other combusted tobacco products. Smoking cessation has
major and immediate health benefits for men and women of all ages,
regardless of health status (Ref. 173 at p. i). Smoking cessation
decreases the risk of the health consequences of smoking, and former
smokers live longer than continuing smokers. For example, persons who
quit smoking before age 50 have one-half the risk of dying in the next
15 years compared with continuing smokers (id. at p. v).
    Smoking cessation reduces the risk of cancers throughout the body
(Ref. 173). For example, although the risk of dying from lung cancer is
22 times higher for male smokers than male nonsmokers (and 12 times
higher for female smokers than female nonsmokers), the risk of lung
cancer after 10 years of abstinence is 30 to 50 percent that of
continuing smokers (id.; Refs. 174 and 175).
    Smoking cessation also reduces the risk of other life-threatening
illnesses that occur in smokers. In addition to reducing the risk of
cancers and the mortality rates of smoking-related diseases, smoking
cessation substantially reduces the risk of other dangerous diseases
that can lead to death or disability and cause a financial strain on
health care resources. For example, smoking cessation substantially
reduces risk of peripheral artery occlusive disease (which can cause
complications that lead to loss of limbs) (Ref. 173). Former smokers
also have half the excess risk of experiencing an abdominal aortic
aneurysm compared to current smokers (id.). Cigarette smoking also
complicates many diseases (e.g., smokers with diabetes have higher risk
of complications, including heart and kidney disease, poor blood flow
in the legs and feet, retinopathy and peripheral neuropathy), and
smoking cessation can alleviate those complications as well (Ref. 17).
    Youth and young adults would experience the greatest benefits from
a nicotine tobacco product standard, because many of them may not
progress beyond experimentation and, therefore, may not experience
dangerous and deadly tobacco-related health effects. Fetuses and
children also would benefit if their parents quit smoking, given the
negative health consequences to the fetus of a smoking mother and the
dangers of secondhand smoke. In addition, children of parents who
smoke, when compared with children of nonsmoking parents, have an
increased frequency of respiratory infections like pneumonia and
bronchitis (Ref. 173). Smoking cessation reduces the rates of these
respiratory symptoms and of respiratory infections (Ref. 176 at p.
467). Children exposed to tobacco smoke in the home also are more
likely to develop acute otitis media (middle ear infections) and
persistent middle ear effusions (thick or sticky fluid behind the
eardrum) (Ref. 173). If parents were more able to quit because these
products become minimally addictive or nonaddictive, youth would
experience these health problems much less frequently.
    Although the health benefits are greater for people who stop
smoking at earlier ages (Refs. 173 and 176), researchers estimate that
smokers can gain years of additional life expectancy no matter when
they quit (Ref. 177). In addition, scientists using data from the
Cancer Prevention Study (CPS-II), but accounting for bias caused by
smoking cessation after baseline, found that even smokers who quit at
age 65 had an expected life expectancy increase of 2 years for men and
3.7 years for women (Ref. 178).
    The benefits continue for those who remain smoke free. At year one,
an individual's added risk of coronary heart disease becomes half that
of a smoker's (Ref. 175). Between 2 and 5 years after cessation, an
individual's stroke risk is reduced to that of a nonsmoker (id.). In
addition, a former smoker's risk of cancers of the mouth, throat,
esophagus, and bladder is halved within five years (id.). By 10-years
post cessation, an individual's risk of cancers of the kidney and
pancreas decreases (id). The risk of coronary heart disease becomes
that of a nonsmoker after 15 years of abstinence (id.).

B. A Nicotine Tobacco Product Standard Could Lead to Substantial
Improvement in Public Health

    As stated throughout this document, nicotine at levels currently
found in tobacco products is highly addictive, and addiction to
nicotine is the ``fundamental reason that individuals persist in using
tobacco products'' (Ref. 17 at p. 105). Although nicotine itself is not
the direct cause of most tobacco-attributable disease, addiction to the
nicotine in tobacco products is the proximate cause of these conditions
because it sustains tobacco use (Refs. 54 and 179). Addiction caused by
nicotine in tobacco is critical in the transition of smokers from
experimentation to sustained smoking and in the maintenance of smoking
for those who want to quit (Ref. 7 at p. 113; Ref. 17). As a result,
FDA expects that making cigarettes minimally addictive or nonaddictive
would reduce tobacco-related harms by promoting smoking cessation or
complete migration to alternative, potentially less harmful
noncombusted products and by reducing initiation. In this section, we
summarize the approach used to describe the possible impact of a
potential nicotine tobacco product standard to the population as a
whole and present the findings of this analysis.
    As discussed elsewhere in this document, FDA is considering the
scope of a potential product standard, and has asked for public
comment. To assess the impact of one potential option that might
maximize the potential public health impact, it may be appropriate to
consider the Apelberg et al. 2018 publication, which presented
simulation modeling of a policy scenario in which the scope of a
potential product standard restricted the nicotine level in cigarettes,
cigarette tobacco, RYO tobacco, cigars (including little cigars, large
cigars, and cigarillos, but not so-called ``premium'' cigars), and pipe
tobacco (other than waterpipe/hookah tobacco). As part of a formal
expert elicitation process (this process centered around three online
conferencing sessions held during January and February 2015, following
a written protocol designed to elicit opinions using a structured,
standardized approach (see Ref. 181 for more details)), eight subject
matter experts were asked to provide their individual estimates of the
anticipated impacts of a hypothetical policy (setting a ``maximum limit
on the amount of nicotine in cigarette tobacco filler'' for the purpose
of reducing nicotine in cigarettes ``to minimally addictive levels'')
and to develop subjective probability distributions for parameters of
interest.
    A more detailed description of the methodology, data sources and
inputs, and results from this analysis can be

found in two peer-reviewed publications (Refs. 180 and 181).
1. Approach to Estimating Impacts to the Population as a Whole
    As described in this document, FDA expects that making cigarettes
minimally addictive or nonaddictive (however that were achieved) would
impact currently addicted smokers by increasing their ability to quit
smoking and affect nonsmokers by reducing the likelihood that they
would become established and addicted smokers. Apelberg et al. 2018
updated a previously published discrete system dynamic population model
to compare projected outcomes for a status-quo scenario (in which no
maximum nicotine level is implemented) with outcomes for a policy
scenario in which a hypothetical regulation lowering nicotine in
cigarettes, and selected other combusted tobacco products, to minimally
addictive was implemented \12\ (Ref. 181).
---------------------------------------------------------------------------

    \12\ The policy scenario presented in Apelberg et al. 2018 (Ref.
181) did not define a specific level of nicotine as minimally
addictive. Rather, the policy scenario simulated implementation of a
hypothetical standard in which cigarettes and certain other
combusted tobacco products were made minimally addictive, informed
by a formal expert elicitation process (Ref. 181), used to estimate
the impact of decreasing the addictiveness of cigarettes on certain
tobacco use behaviors. Given the lack of specificity in the
hypothetical scenario posed in the Apelberg et al. study, caution is
warranted in extrapolating its results to the assessment of a
particular policy.
---------------------------------------------------------------------------

    The model incorporated, based on estimates of subject matter
experts, the following tobacco use transitions to estimate the impact
of the policy: (1) Cigarette smoking cessation; (2) cigarette smokers
switching to noncombusted tobacco products (e.g., smokeless tobacco
and/or electronic cigarettes) rather than quitting tobacco use
entirely; (3) continuing smokers becoming dual users of cigarettes and
noncombusted tobacco products; (4) nonsmokers initiating regular
cigarette smoking; and (5) nonsmokers who have been dissuaded from
smoking cigarettes and certain other combusted tobacco products, who
may instead initiate use of a noncombusted tobacco product. The model,
based on input parameters derived from expert estimates, projected the
impact of the policy on four main outcomes: (1) Prevalence of cigarette
smoking and noncombusted tobacco product use; (2) the number of
individuals dissuaded from cigarette smoking; (3) cumulative number of
tobacco-attributable deaths avoided; and (4) cumulative life years
gained as a result of a regulation setting a maximum nicotine level.
    The methodology implemented in this analysis has been detailed
elsewhere (Refs. 180 and 181). Briefly, the simulation begins with an
initial population that reflects the sex, age, and tobacco use
distribution (i.e., never, current, and former use of cigarettes and
noncombusted products) of the U.S. population in 2015, based on U.S.
Census Bureau estimates. The analysis projects population changes for
2016-2100 in 1-year increments, while accounting for births, net
migration (which accounts for immigration and emigration) and deaths,
the last of which is a function of age, sex, and tobacco use status.
Baseline estimates for tobacco use status (combinations of current,
former, and never use for cigarettes and noncombusted products) by sex,
age, and time since cessation (for cigarettes only) were obtained from
the 2015 National Health Interview Survey (NHIS) for adults (Ref. 1)
and the 2015 NYTS for youth (Ref. 182). Mortality rates and relative
risks by tobacco use status were obtained from U.S. vital statistics
data, NHIS data linked for mortality followup (for never smoker
mortality rates and cigarette smoking relative risks), and the CPS-II
(for smokeless tobacco product relative risks). In the absence of data
on the long-term health risks of ENDS, Apelberg et al. assumed that the
ENDS products carried the same risks associated with traditional
smokeless tobacco (see Ref. 181 for more detail).
    Quantitative inputs for rates of post-policy smoking cessation,
switching, and dual use in the hypothetical policy scenario were
obtained through a formal expert elicitation process. The methodology
used to identify experts, develop the protocol, conduct the
elicitation, and summarize the findings has been described in detail
elsewhere (Ref. 181 at Appendix). Briefly, elicitation candidates with
expertise in tobacco science and policy were identified, ranked, and
recruited in accordance with a pre-specified protocol, based on
publication history and accounting for potential conflicts of interest.
Candidates were required to self-certify that they were free of any
actual, apparent, or potential conflicts of interests. The elicitation
process centered around three online conferencing sessions held during
January and February 2015, following a written protocol designed to
elicit opinions using a structured, standardized approach (see Ref. 181
for more details). Briefing books with key papers on the topics of
interest as well as background data on tobacco use and policy were
provided to a panel of eight experts prior to the conference sessions.
Experts were asked to identify any other relevant information to share
with the panel. Detailed written questionnaires were completed by each
expert as independent take-home exercises. To maintain the independence
of the experts and encourage open discussion, involvement of FDA staff
was limited.
    To explore the potential impact of a product standard that would
maximally benefit population health, the experts were asked to assume
that combusted tobacco products that could be viewed as highly likely
to serve as substitutes for traditional cigarettes (i.e., RYO tobacco,
pipe tobacco, nonpremium cigars) would be included in the policy, while
other tobacco products (i.e., premium cigars, waterpipe/hookah, ENDS,
smokeless tobacco) would be excluded.\13\ The eight experts were asked
to predict and quantify the anticipated impact of the policy on the
following model parameters: (1) Cigarette smoking cessation rates; (2)
switching from cigarette smoking to other tobacco products excluded
from the hypothetical policy scenario; (3) dual use rates; (4)
cigarette smoking initiation rates; and (5) initiation rates for other
tobacco products excluded from the hypothetical policy scenario. Each
of the eight experts was asked to provide his or her best estimate of
the parameters' true value, estimates of the minimum and maximum
plausible values, and estimates of the 5th, 25th, 75th and 95th
percentile values. Experts were asked first about impacts in the first
year immediately following the potential product standard's
implementation and then about the impacts in the years following the
first full year of implementation. Experts had the option of providing
separate estimates of impacts for males and females for the initial and
subsequent years. For each question, experts were asked to provide the
factors they considered pertinent to answering the question, including
the studies and research findings most influential to informing their
views, and to rate their familiarity with the relevant literature. The
elicitation process provided the experts with opportunities to interact
and discuss divergent views, from

which each expert generated his/her initial and final estimates.
---------------------------------------------------------------------------

    \13\ While the policy scenario presented in Apelberg et al.,
2018 (Ref. 181) is based on reduction in nicotine level in
cigarettes, cigarette tobacco, RYO tobacco, certain cigars and pipe
tobacco, the estimated population impact is based on reductions in
cigarette smoking. FDA notes that not accounting for reductions in
the use of other combusted tobacco products may underestimate the
overall impact of this policy scenario.
---------------------------------------------------------------------------

    The eight experts' judgments about the potential values of these
parameters are published in Apelberg et al. 2018 (Ref. 181). While
parameter estimates and their probability distributions varied somewhat
between participants, most experts had the view that making cigarettes
and certain other combusted tobacco products minimally addictive would
lead to substantial initial and long-term increases in smoking
cessation among cigarette smokers and decreased initiation among
nonsmokers. Distributions provided by the eight experts' parameter
estimates were substantially broad in range. For example, for both male
and female non-smokers, the median minimum and maximum estimates from
the eight experts on the ``percent of reduction in annual smoking
initiation rates'' after the first year in response to the policy
ranged from 10 percent to 90 percent. For both male and female smokers,
the median minimum and maximum estimates from the eight experts on the
``percent of current smokers who quit smoking as a result of the
policy'' within the first year after policy implementation ranged from
4 percent to 50 percent.
    To account for uncertainty associated with the expected impact of
the policy scenario, Apelberg et al. 2018 used the distributions of the
experts' estimates in a Monte Carlo simulation. A Latin Hypercube
sampling with 1,000 sample values was performed for each of the
expert's response distributions. For each simulation, the policy
scenario was compared to the baseline scenario to estimate changes in
the outcomes described above. A summary of distribution responses are
provided in Apelberg et al. 2018.
2. Projected Impacts to Users, Nonusers, and the Population as a Whole
    As illustrated in Figure 1 (Ref. 181), using the experts' input
estimates for the parameters described previously, and assuming that
the policy is implemented in 2020, the simulation model projected that
cigarette smoking prevalence declines substantially in the policy
scenario within the first year of implementation of the hypothetical
policy scenario to a median value of 10.8 percent compared with 12.8
percent in the baseline scenario. In subsequent years, the simulation
model projects that the difference in cigarette smoking prevalence
between the scenarios continues to grow due to the experts' estimates
of sustained increases in cessation and decreases in initiation in the
policy scenario. The projected smoking prevalence drops to a median
value of 1.4 percent (5th and 95th percentile projections range from
0.2 percent to 5.9 percent) under the policy scenario by 2060 compared
to 7.9 percent under the baseline. Smoking prevalence estimates for the
year 2100 are comparable to those for 2060.
    Concurrent with a projected reduction in cigarette smoking is a
projected increase in noncombusted product use. Adult noncombusted
tobacco product use is higher in the hypothetical policy scenario
compared to the baseline scenario within the first year of
implementation of the potential product standard (Ref. 181 at Figure
1), due to estimated increases in switching from cigarette smoking and
transitions to dual cigarette and noncombusted product use as a result
of the hypothetical policy scenario. The prevalence of noncombusted
tobacco product use remains higher in the policy scenario over time due
to the experts' predictions that there would be both increased uptake
among smokers (through either complete switching or dual use) and
increased initiation due to some dissuaded cigarette initiators taking
up noncombusted products instead.
    Table 2 provides a projection of the number of individuals who
would not become cigarette smokers over time as a result of the
hypothetical policy scenario. Since it is assumed, based on expert
input, that there would be a sustained decrease in cigarette smoking
initiation rates, the model projects that the cumulative number of
dissuaded smoking initiates continues to increase over time. By 2100,
the median estimate from the model, based on the experts' estimates of
potential initiation rates as a result of the policy, is that more than
33 million youth and young adults who would have otherwise initiated
regular smoking would not start as a result of the hypothetical policy
scenario (5th and 95th percentile projections range from 8.0 million to
64.1 million).
    Using the eight experts' estimates for the percent of current
smokers who would quit smoking after implementation of the policy,
approximately 5 million additional smokers are estimated to quit
smoking within one year after implementation of the product standard
(5th and 95th percentile projections range from 110,000 to 19.7
million), compared to the baseline scenario. The number of additional
smokers quitting would increase by approximately 13 million within 5
years after policy implementation (5th and 95th percentile projections
range from 430,000 to 30.5 million), compared to the baseline scenario.

 Table 2--Projected Number of Individuals Who Would Not Initiate Regular
 Smoking as a Result of a Nicotine Tobacco Product Standard Implemented
                                 in 2020
------------------------------------------------------------------------
                                        Cumulative new smoking initiates
                                             avoided (in millions)
                 Year                 ----------------------------------
                                           5th                   95th
                                        percentile   Median   percentile
------------------------------------------------------------------------
2040.................................          2.0      8.1         15.6
2060.................................          3.9     16.0         31.0
2080.................................          5.9     24.4         47.2
2100.................................          8.0     33.1         64.1
------------------------------------------------------------------------

    Table 3 presents the estimated cumulative number of tobacco-
attributable deaths potentially avoided and life years gained due to
the experts' determinations that smoking rates would decrease as a
result of the hypothetical policy scenario. By 2060, it is estimated
that a median value of almost 3 million deaths due to tobacco would be
avoided (5th and 95th percentile projections range from 0.7 million to
4.3 million), rising to 8.5 million by the end of the century (5th and
95th percentile projections range from 2.2 million to 11.2 million).
The reduction in premature deaths attributable to the hypothetical
policy scenario would result in approximately 33 million life years
gained by 2060 (5th and 95th percentile projections range from 7.8
million to 53.9 million) and over 134 million life years gained by 2100
(5th and 95th percentile projections range from 31.6 million to 183.0
million).

 Table 3--Projected Number of Tobacco-Attributable Deaths Avoided and Life Years Gained Due to Reduced Smoking as a Result of a Nicotine Tobacco Product
                                                              Standard Implemented in 2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Cumulative tobacco attributable deaths avoided      Cumulative life years gained (millions)
                                                                            (millions)                   -----------------------------------------------
                          Year                           ------------------------------------------------
                                                                                95th       5th percentile      Median           95th
                                                          5th percentile      Median        percentile                                      percentile
--------------------------------------------------------------------------------------------------------------------------------------------------------
2040....................................................             0.3             0.9             1.4             2.5             6.8            11.5
2060....................................................             0.7             2.8             4.3             7.8            33.1            53.9
2080....................................................             1.3             5.6             7.9            16.5            79.6           118.0
2100....................................................             2.2             8.5            11.2            31.6           134.4           183.0
--------------------------------------------------------------------------------------------------------------------------------------------------------

3. Request for Comments
    Based on the experts' judgments that reducing nicotine levels in
combusted tobacco products would increase smoking cessation and
decrease smoking initiation, and calculations from the simulation model
describing the potential impact of reducing nicotine to minimally
addictive levels in cigarettes and selected other combusted tobacco
products, FDA anticipates a significant public health benefit to the
United States. This hypothesis is based on the assumption that the
reduction in nicotine levels in combusted tobacco products would create
substantial reductions in smoking prevalence due to increased smoking
cessation and reduced initiation of regular smoking. Given that
research studies cannot easily replicate the condition of a nationally
enforced restriction on nicotine to minimally addictive levels in
cigarettes, FDA sought expert opinion through an established
elicitation process to provide the best estimates for the potential
values and associated ranges of the likely impact of a hypothetical
reduction in cigarettes' nicotine content (to be achieved by a
potential product standard) on tobacco use behaviors. FDA requests
data, evidence, and other information regarding the potential public
health benefits (or risks) if FDA were to move forward in this area.
Specifically, FDA is seeking data, evidence, and other information that
could inform the following five parameter inputs that would be helpful
in determining the public health impact of a nicotine tobacco product
standard:
     Percent of current cigarette smokers who would quit
cigarette smoking as a result of a standard restricting nicotine to
minimally addictive levels.
     Percent of quitters switching to other combusted or
noncombusted tobacco products.
     Percent of continuing smokers who become dual product
users of cigarettes and noncombusted tobacco products.
     Percent reduction in annual smoking initiation rates.
     Percent of dissuaded smoking initiates who initiate
noncombusted tobacco product use instead.

Please include your assumptions about the scope of the standard and
data that supports your estimates.
4. Additional Public Health Benefits
    While the projections from the simulation model calculating the
potential impact from reducing nicotine to minimally addictive levels
in cigarettes suggest a significant public health benefit to the United
States resulting from substantial reductions in smoking prevalence
(based on the model's inputs, which reflect the experts' assessments
that the reduction in nicotine levels in combusted tobacco products
would create substantial increases in smoking cessation and reductions
in initiation of regular smoking), the analysis does not address
certain potential added benefits. First, the model does not account for
increased quality of life from decreased tobacco-related morbidity, nor
does it account for cost savings from medical care averted. Second, the
analysis does not account for the impacts of secondhand smoke exposure
on public health in the United States. Third, the analysis does not
account for reductions in harms caused by smoking-related fires.
Fourth, the potential impact described does not account for the
potential impact on population health from use of the other combusted
products (e.g., cigars, pipes) if the assumed rule were to cover such
products. Finally, these projections do not assess whether there could
be potential health benefits associated with smokers cutting down on
the number of cigarettes smoked as a result of the standard.

VI. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. National Center for Health Statistics, National Health Interview
Survey website, available at https://www.cdc.gov/nchs/nhis/data-questionnaires-documentation.htm.
2. Benowitz, N.L., and J.E. Henningfield, ``Reducing the Nicotine
Content to Make Cigarettes Less Addictive,'' Tobacco Control,
22(Suppl 1):i14-i17, 2013.
3. Hatsukami, D.K., S.J. Heishman, R.I. Vogel, et al., ``Dose-
Response Effects of Spectrum Research Cigarettes,'' Nicotine &
Tobacco Research, 15(6):1113-1121, 2013, available at http://ntr.oxfordjournals.org/content/15/6/1113.long#T4.
4. Hatsukami, D., M. Kotlyar, L.A. Hertsgaard, et al., ``Reduced
Nicotine Content Cigarettes: Effects on Toxic Exposure, Dependence,
and Cessation,'' Addiction, 105(2):343-355, 2010.
5. Benowitz, N.L., S.M. Hall, S. Stewart, et al., ``Nicotine and
Carcinogen Exposure With Smoking of Progressively Reduced Nicotine
Content Cigarettes,'' Cancer Epidemiology Biomarkers & Prevention,
16(11):2479-2485, 2007.
6. Carter B.D., C.C. Abnet, D. Fesankich, et al., ``Smoking and
Mortality--Beyond Established Causes,'' New England Journal of
Medicine, 372:7, 631-640, 2015.
7. U.S. Department of Health and Human Services, ``The Health
Consequences of Smoking--50 Years of Progress: A Report of the
Surgeon General''; 2014.
8. U.S. Department of Health and Human Services, ``Preventing
Tobacco Use Among Youth and Young Adults,'' A Report of the Surgeon
General; 2012.
9. Poorthuis, R.B., N.A. Goriounova, J.J. Couey, et al., ``Nicotinic
Actions on Neuronal Networks for Cognition: General Principles and
Long-Term Consequences,'' Biochemical Pharmacology, 78(7):668-676,
2009.
10. Slovic, P., Smoking: Risk Perception, & Policy, II.6 ``Cigarette
Smokers: Rational Actors or Rational Fools?'' Thousand Oaks, CA:
Sage Publications, 2001.
11. Centers for Disease Control and Prevention, ``High School
Students Who Tried to Quit Smoking Cigarettes--United States,
2007,'' Morbidity and

Mortality Weekly Report, 58(16); 428-431, May 1, 2009.
12. Johnston L.D., O'Malley P.M., Bachman J.G., & Schulenberg J.E.,
``Monitoring the Future National Survey Results on Drug Use, 1975-
2004,'' Volume I, Secondary school students (NIH Publication NO. 05-
5727), Bethesda, MD: National Institute on Drug Abuse.
13. Institute of Medicine of the National Academies, ``Ending the
Tobacco Problem: A Blueprint for the Nation,'' 2007, available at
http://nationalacademies.org/hmd/reports/2007/ending-the-tobacco-problem-a-blueprint-for-the-nation.aspx.
14. Levin, E.D., S. Lawrence, A. Petro, et al., ``Adolescent vs.
Adult-Onset Nicotine Self-Administration in Male Rats: Duration of
Effect and Differential Nicotinic Receptor Correlates,''
Neurotoxicology and Teratology, 29(4):458-465, 2007.
15. Apelberg B.J., C.G. Corey, A.C. Hoffman, et al., ``Symptoms of
Tobacco Dependence Among Middle and High School Tobacco Users,''
American Journal of Preventive Medicine, 47(2S1):S4-S14, 2014.
16. Counotte, D.S., A.B. Smit, T. Battij, et al., ``Development of
the Motivational System During Adolescence, and Its Sensitivity to
Disruption by Nicotine,'' Developmental Cognitive Neuroscience,
1(4):430-443, 2011.
17. U.S. Department of Health and Human Services, ``How Tobacco
Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-
Attributable Disease,'' A Report of the Surgeon General; 2010.
18. Lenk, K.M., T.L. Toomey, Q. Shi, et al., ``Do Sources of
Cigarettes Among Adolescents Vary by Age Over Time?'' Journal of
Child & Adolescent Substance Abuse, 23:137-143, 2014.
19. Kann, L., T. McManus, W.A. Harris, et al., ``Youth Risk Behavior
Surveillance--United States, 2015,'' Morbidity and Mortality Weekly
Report, 65(6); June 10, 2016.
20. Grucza, R.A., A.D. Plunk, P.R. Hipp, et al., ``Long-Term Effects
of Laws Governing Youth Access to Tobacco,'' American Journal of
Public Health, 103(8); 1493-1499, 2013.
21. Centers for Disease Control and Prevention, ``Quitting Smoking
Among Adults--United States, 2001-2010,'' Morbidity and Mortality
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    Dated: March 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05345 Filed 3-15-18; 8:45 am]
BILLING CODE 4164-01-P