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Federal Register/Vol. 64, No. 55/Tuesday, March 23, 1999/Notices

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Federal Register/Vol. 64, No. 55/Tuesday, March 23, 1999/Notices 14086 Federal Register / Vol. 64, No. 55 / Tuesday, March 23, 1999 / Notices DEPARTMENT OF HEALTH AND through programs of information, constituents in a smokeless tobacco HUMAN SERVICES education, and research. product that are volatile at temperatures HHS uses the information collected to of 99 degrees centigrade. pH is defined Centers for Disease Control and exercise its authority under CSTHEA to as the negative logarithm of the molar Prevention conduct research on the addictive concentration of hydrogen ions in an nature of nicotine and general health aqueous solution and is a quantitative Notice Regarding Requirement for effects of using smokeless tobacco. measure of acidity or alkalinity. The Annual Submission of the Quantity of Nicotine data will provide a more degree of nicotine ionization is Nicotine Contained in Smokeless complete picture of the addictive nature calculated from the Henderson- Tobacco Products Manufactured, of smokeless tobacco products. Also, as Hasselbalch equation. Un-ionized Imported, or Packaged in the United authorized in the statute, HHS may nicotine is known to be the form of States report to the Congress information nicotine absorbed most easily in the regarding its current and proposed mouth. This protocol will provide CDC AGENCY: Centers for Disease Control and research relative to nicotine levels in with information on levels of nicotine Prevention (CDC), Department of Health smokeless tobacco products. CSTHEA found in smokeless tobacco products and Human Services. further requires that individuals who manufactured, packaged, or imported ACTION: Notice. manufacture, package, or import during the previous calendar year. The smokeless tobacco products report to schedule for reporting this information SUMMARY: This notice establishes a HHS the list of ingredients added to to CDC corresponds to the reporting of uniform protocol for the analysis of tobacco in the manufacture of such ingredients added to tobacco in the nicotine, total moisture, and pH in products, and this requirement has been manufacture of smokeless tobacco smokeless tobacco products. This implemented by a previous notice (59 products November 8, 1994 (59 FR protocol was designed to implement the FR 4714,). 55670,). requirement of the Comprehensive In 1989 the smokeless tobacco Following public request, on June 2, Smokeless Tobacco Health Education industry submitted a business review 1997, a notice (62 FR 29729) was Act (CSTHEA) of 1986 (15 U.S.C. 4401 letter to the Department of Justice (DOJ), published extending the comment et seq., Pub. L. 99±252), which requires in accordance with 28 CFR 50.6. This period on the proposed protocol by an that each entity manufacturing, letter requested approval of a additional 30 days to July 2, 1997. A packaging, or importing smokeless collaborative industry effort to develop summary of the comments received and tobacco products shall annually provide a uniform analytical protocol for CDC's response follows. the Secretary of Health and Human determining the nicotine and moisture One respondent, on behalf of several Services (HHS) with a specification of content of smokeless tobacco products. smokeless tobacco manufacturers, had the quantity of nicotine contained in In January 1993, DOJ extended several comments regarding the each smokeless tobacco product. permission to the smokeless tobacco collection of data. The respondent DATES: The first report of information is industry to develop a uniform analytical asserted that the protocols exceeded due June 30, 1999, with subsequent protocol for this purpose. A work group statutory authorization by collecting pH submissions due by March 31 of each representing the 10 major domestic and free base (hereinafter referred to as year. manufacturers of smokeless tobacco was ``un-ionized'', as reflected in the revised ADDRESSES: The information shall be convened on July 7, 1993. The protocol) nicotine. Furthermore, the submitted to: Michael P. Eriksen, Sc.D., workgroup developed and submitted to respondent felt that the legislative Director, Office on Smoking and Health, CDC for approval the ``Protocol for history of CSTHEA contemplates the National Center for Chronic Disease Analysis of Nicotine in Smokeless reporting of nicotine content alone. Prevention and Health Promotion, Tobacco Products.'' The protocol was It is CDC's belief that the collection of Centers for Disease Control and revised by CDC based on individual pH of smokeless tobacco products and Prevention (CDC), 4770 Buford comments from peer reviewers and the the un-ionized nicotine content of each Highway, NE., Atlanta, GA 30341±3724. National Center for Environmental is authorized by section 4 of CSTHEA. Health, CDC. The revised protocol, There is ample scientific evidence that FOR FURTHER INFORMATION CONTACT: ``Protocol for Analysis of Nicotine, Total mere quantity of nicotine alone is Michael P. Eriksen, Sc.D., Director, Moisture, and pH in Smokeless Tobacco insufficient in determining its effect on Office on Smoking and Health, Products,'' is hereafter referred to as the a user; knowledge of pH and un-ionized telephone: (770) 488±5701. ``protocol.'' nicotine content of the overall nicotine SUPPLEMENTARY INFORMATION: According On May 2, 1997, a notice (62 FR quantity is essential in determining the to a 1986 report of an Advisory 24115) was published in accordance rate of nicotine absorption. pH and un- Committee to the Surgeon General, with the Paperwork Reduction Act to ionized nicotine content are essential smokeless tobacco represents a solicit public comment on the proposed factors affecting nicotine bioavailability. significant health risk, is not a safe collection of data. A notice was also Furthermore, Congress has never substitute for cigarette smoking, can published (62 FR 24116, May 2, 1997) defined exactly what it meant by cause cancer and a number of to solicit public comment on the ``quantity of nicotine'' in section 4(b) of noncancerous oral conditions, and can protocol. The protocol consists of CSTHEA. In light of ample scientific lead to nicotine addiction. standard laboratory methods to measure evidence indicating the importance of The Centers for Disease Control and nicotine, moisture, and pH in smokeless pH and un-ionized nicotine content in Prevention's (CDC) Office on Smoking tobacco products, and an equation assessing the overall quantity of and Health (OSH) has primary (Henderson-Hasselbalch) to calculate nicotine, CDC's interpretation of its responsibility for the Department of un-ionized nicotine. Nicotine is the statutory authority is clearly Health and Human Services' (HHS) major alkaloid in tobacco and the drug permissible. tobacco and health program. The overall in tobacco that causes addiction. In the It is CDC's belief that the legislative goal of this program is to reduce death protocol, moisture is referred to as total history provides support for requiring and disability resulting from cigarette moisture because the method measures the reporting of moisture, pH, and un- smoking and other forms of tobacco use the amount of water and tobacco ionized nicotine content. The Senate VerDate 17-MAR-99 15:59 Mar 22, 1999 Jkt 183247 PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 E:\FR\FM\23MRN3.XXX pfrm01 PsN: 23MRN3 Federal Register / Vol. 64, No. 55 / Tuesday, March 23, 1999 / Notices 14087 Report accompanying and establishing public with sufficient opportunity to preparation of a standard curve for the Congress' views on CSTHEA repeatedly comment. Standards Addition Assay that emphasized that ``it is essential that we This respondent also commented that encompasses the range of values inform the public of the health effects of CDC failed to meet the requirements of expected from adding known smokeless tobacco use and continue the Paperwork Reduction Act by failing concentrations of nicotine to the research on such health effects as to provide the public with an accurate smokeless tobacco product. Also, CDC expeditiously as possible'' (Senate estimate of the burden of compliance. revised the protocol to specify when the Report 99±209, Dec. 4, 1985, p.13). CDC disagrees. CDC based its original Standards Addition Assay is to be Since scientific evidence has estimate on the figures that were conducted by the testing facility. established that knowledge of pH and submitted by the manufacturers Regarding use of a vegetable-based un-ionized nicotine content is essential themselves. Moreover, the 60-day notice matrix, CDC acknowledges that a in determining the health effects of and comment period is designed to nicotine-free tobacco surrogate is not smokeless tobacco, the reporting of solicit comment on the accuracy of the readily available to serve as a vegetable- these elements is supported by the agency's estimate of the burden of the based matrix; that is why the protocol legislative history. proposed collection of information. 44 thus specifies adding known The respondent also commented that U.S.C. 3506(c)(2)(A)(ii). The tobacco concentrations of nicotine to the CDC failed to comply with procedural manufacturers felt that the estimate of smokeless tobacco product when obligations in violation of 5 USC § 551 burden had changed and commented as performing the Standards Addition et seq., the Administrative Procedure such at that time. CDC then sought Assay. CDC revised the text in Endnote Act (APA). Specifically, the respondent revised estimates from the 1 of the protocol to eliminate the phrase claimed that CDC failed to provide manufacturers. Only one manufacturer
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