[Federal Register Volume 59, Number 21 (Tuesday, February 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2184]


[[Page Unknown]]

[Federal Register: February 1, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

 

Notice Regarding Requirement for Submission of List of 
Ingredients Added to Tobacco in the Manufacture of Smokeless Tobacco 
Products

AGENCY: Centers for Disease Control and Prevention (CDC), Public Health 
Service, HHS.

ACTION: Notice.

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SUMMARY: This notice implements the requirement of the Comprehensive 
Smokeless Tobacco Health Education Act of 1986 (Public Law 99-252) that 
each person who manufactures, packages, or imports smokeless tobacco 
shall provide the Secretary of Health and Human Services (HHS) annually 
with a list of ingredients added to tobacco in the manufacture of 
smokeless tobacco products. (This statute also requires reporting to 
HHS the nicotine content of smokeless tobacco products. The nicotine 
reporting requirement will be implemented at a later date.)

DATES: The first ingredient list is due on April 4, 1994, and shall 
identify all ingredients added to tobacco in the manufacture of 
smokeless tobacco products marketed on December 31, 1993. Beginning in 
1994 and each subsequent calendar year, the ingredient list will be due 
on December 31, and shall identify any changes in the ingredients added 
to tobacco in the manufacture of smokeless tobacco products at any time 
during the previous twelve months.

ADDRESSES: The list shall be submitted to: Michael P. Eriksen, Sc.D., 
Director,Office on Smoking and Health, National Center for Chronic 
Disease Prevention and Health Promotion, Centers for Disease Control 
and Prevention (CDC), 4770 Buford Highway, NE., Atlanta, GA 30341-3724.

FOR FURTHER INFORMATION CONTACT: Michael P. Eriksen, Sc.D., Director, 
Office on Smoking and Health, (404) 488-5701.

SUPPLEMENTARY INFORMATION: Section 4(a) of Public Law 99-252 (15 U.S.C. 
4403(a)) requires manufacturers, packagers, and importers of smokeless 
tobacco products to provide the Secretary of HHS annually with a list 
of all ingredients added to tobacco in the manufacture of smokeless 
tobacco products. This statute also stipulates that the list need not 
identify the company which uses the ingredients or the brand of 
smokeless tobacco which contains the ingredients.
    The implementation procedures HHS has established for submitting 
the ingredient information require respondents to report each 
ingredient by chemical name and Chemical Abstract Service (CAS) 
Registry Number. This format for reporting ingredients is consistent 
with accepted reporting practices for other companies currently 
required to report ingredients added to other consumer products, 
including cigarettes.
    The statute permits a person or group of persons required to submit 
an ingredient list to HHS to designate an individual or entity to 
provide information on their behalf. In such case, HHS procedures 
require the designated individual or entity to identify for HHS the 
person or group of persons on whose behalf the ingredient list is being 
submitted.
    HHS has established strict procedures for assuring the 
confidentiality of the information submitted in accordance with section 
4(b)(2)(C) of Public Law 99-252 (15 U.S.C. 4403(b)(2)(c)). The 
information will be treated as trade secret or confidential information 
subject to 5 U.S.C. 552(b)(4). Access to the information will be 
limited to those authorized by the Secretary in carrying out their 
official duties and to duly-authorized committees or subcommittees of 
the Congress that submit a written request for the information.

Information Collection Provisions:

    This Notice contains information collections which have been 
approved by the Office of Management and Budget under the Paperwork 
Reduction Act of 1980 and assigned the control number 0920-0338. The 
title, description, and respondent description of the information 
collection are shown below with an estimate of the annual reporting and 
record keeping burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    Title: Ingredients Added to Tobacco in the Manufacture of Smokeless 
Tobacco Products.
    Description: The Comprehensive Smokeless Tobacco Health Education 
Act of 1986 requires HHS to collect this information. HHS is authorized 
to conduct research on the potential health effects of the ingredients, 
and to report to the Congress as appropriate.
    Description of Respondents: Businesses or Other For-Profit 
Organizations.
    Estimated Annual Reporting and Recordkeeping Burden: The Office on 
Smoking and Health (OSH) contacted five smokeless tobacco 
manufacturers, through the law firm of Patton, Boggs and Blow, which 
will submit ingredient information in order to estimate the annualized 
cost for reporting ingredient information to the Department of Health 
and Human Services. The estimated average cost to industry for this 
three year period is $4,314. This is based on an annualized estimated 
cost of $1,438 per company with an annual estimated cost range of $250 
to $3500 per company per year. The estimated cost to the government for 
this collection and storage over a three year period is $18,000.00. 
This cost is based on an annualized estimated cost of $6,000.00 for 
collection and storage.
    There are 11 manufacturers, packagers, and importers of smokeless 
tobacco products in the U.S. In November 1992, OSH contacted five 
companies, through the law firm of Patton, Boggs and Blow, which will 
submit ingredient information to the Department of Health and Human 
Services, regarding the estimated response burden to the industry. 
Patton, Boggs and Blow reported that the annual response burden for 
each company it represents ranges from 4 to 30 manhours, with an 
average burden of 15 hours per company.

    Dated: January 25, 1994.
Walter R. Dowdle,
Deputy Director, Centers for Disease Control and Prevention (CDC).

Guidelines for Maintaining and Releasing Privileged Information 
Obtained in Accordance With Sec. 4(b)(2)(a) of Public Law 99-252 (15 
U.S.C. 4403)

1. Purpose

    These Guidelines establish minimum requirements to maintain, 
protect and release documents that contain privileged information 
regarding ingredients in smokeless tobacco products. The Guidelines 
establish individual responsibility for the accountability and 
protection of privileged information on ingredients added to tobacco in 
the manufacture of smokeless tobacco products and the quantity of 
nicotine in each such product. The Comprehensive Smokeless Tobacco 
Education Act of 1986 (Pub. L. 99-252 (15 U.S.C. 4403)) requires 
manufacturers, packagers, and importers of smokeless tobacco products 
to submit such information annually to the Secretary of Health and 
Human Services.

2. Policy

    Employees of the Department of Health and Human Services shall take 
such action as may be necessary to assure implementation of statutory 
requirements to safeguard privileged information. In accordance with 
Public Law 99-252 (15 U.S.C. 4403 (b)(2)), HHS shall treat the lists of 
ingredients added to tobacco in the manufacture of smokeless tobacco 
products as trade secret or confidential information. HHS shall not 
reveal the information except as authorized by the statute. Privileged 
information shall be released to Congress only as provided in section 
4(b) of Public Law 99-252 (15 U.S.C. 4403 (b)) and to employees of the 
Department authorized to review the information in carrying out their 
official duties under Public Law 99-252 (15 U.S.C. 4403(b)(2)). All 
other requests for the privileged information shall be denied.
    If HHS receives a request for the privileged information under the 
Freedom of Information Act, the Freedom of Information Officer shall 
deny the request in accordance with the provisions of 5 U.S.C. 
552(b)(3) and 552(b)(4), section 4(b)(2)(A) of Public Law 99-252 (15 
U.S.C. 4403(b)(2)), which require the protection of confidential or 
trade secret information.

3. Statutory Requirements

    Statutory requirements for safeguarding the subject privileged 
information are as follows:
    a. Sections 4(b)(2) of Public Law 99-252 (15 U.S.C. 4403(b)(2)) 
(Comprehensive Smokeless Tobacco Health Education Act of 1986) 5 U.S.C. 
552(b)(4) (Freedom of Information Act).

4. Definitions

    a. Document Control Officer. This Officer is the Departmental 
official designated in writing as having responsibility for the 
Department's control of privileged information pertaining to the 
smokeless tobacco product ingredients. The Document Control Officer 
shall be the Director, Office on Smoking and Health, National Center 
for Chronic Disease Prevention and Health Promotion, Centers for 
Disease Control and Prevention (CDC).
    b. Privileged Information. As used in this Guideline, privileged 
information refers to (i) any information provided to HHS in accordance 
with section 4(a)(1) of Public Law 99-252 (15 U.S.C. 4403(a)(1)), and 
(ii) any other materials derived from the information provided.
    c. Secure Files Area. A room or rooms that are locked during non-
duty hours.
    d. Secure Files Containers. Any equipment that is locked when 
unattended and that cannot be hand carried (e.g., Power Files and 
Lektrievers, filing cabinets and shelf units, credenzas, desk 
pedestals, etc.,).

5. Responsibilities

    The Document Control Officer shall:
    (1) Provide written guidance to HHS organizational components 
regarding the action necessary to assure compliance with the provisions 
of these Guidelines.
    (2) Maintain and verify the operation of an effective document 
control system.
    (3) Assure adherence to the requirements these Guidelines 
establish.
    (4) Investigate reports of overdue documents.

6. Persons Authorized to Have Access to Privileged Information

    The following may be granted access to privileged information under 
the conditions specified:
    a. Department Employees. Upon written authorization from the 
Document Control Officer, regular or special employees of the 
Department are permitted access to privileged information needed to 
perform their official duties. Any employee permitted such access 
shall, prior to receiving privileged information, read and execute a 
Commitment to Protect Confidential Information form.
    b. In accordance with section 4(b)(2)(B) of Public Law 99-252 (15 
U.S.C. 4403(b)(2)(B)), the Department shall provide privileged 
information submitted under that Act to a duly-authorized committee or 
subcommittee of Congress upon its written request. When documents are 
so released, the Department, at the same time, shall provide written 
notice of the release to the person who provided the privileged 
information.
    Users of files containing privileged information are responsible 
for complying with these HHS Guidelines and other accountability 
procedures that the Document Control Officer establishes to protect the 
files.

7. Document Accountability

    The Document Control Officer shall authorize, in writing, the 
release of the privileged information. Persons accessing the privileged 
information shall execute a Commitment to Protect Confidential 
Information form and provide personal identification to verify their 
identity.
    a. Charge-Outs. When privileged information documents are charged 
out, the recipient shall sign a Commitment to Protect Confidential 
Information form. This form, which includes identifying information and 
anticipated date of return, also shall serve as a document receipt 
form. The person who certifies to accept and protect the privileged 
information is responsible for the file documents received. Receipts 
shall be kept current so that documents can be located readily.
    b. Control, Follow-up, and Verification of Locations. The Document 
Control Officer shall require the return of each document by the return 
date stipulated on the receipt. If use of the document is necessary for 
an additional period, the Document Control Officer may authorize an 
extension and shall document the files accordingly. When the privileged 
information documents are returned, the actual date of return shall be 
recorded on the receipt form.
    c. Report of Lost Documents. Individuals who have received 
privileged information documents shall notify the Document Control 
Officer in writing when privileged information files cannot be located. 
The notification shall include:
    (1) The name and organizational location of the individual 
authorized to possess the documents at the time of loss;
    (2) The identification and description of each missing file;
    (3) A summary of the efforts made to locate the missing file.

8. Document Protection

    Document protection shall include the following:
    a. During Non-Working Hours. All privileged information must be 
locked in an approved secure files area or in an approved secure files 
container during non-working hours.
    b. During Working Hours. When not in actual use by an authorized 
employee, privileged information shall be protected by using the 
protective measures required for non-working hours.

9. Transfer of Privileged Information

    Method of Transmission. The preferred method is person-to-person 
transmission. When this is not practical, the privileged information is 
to be sent through the U.S. Registered Mail system, unless a written 
exception has been obtained on an individual basis from the Document 
Control Officer.

10. Document Reproduction

    Privileged information documents will be reproduced only as 
required for the performance of official business, and only by those 
persons so authorized by the Document Control Officer.

11. Document Disposition

    The documents provided to the Department in accordance with Section 
4(a)(1) of the Comprehensive Smokeless Tobacco Health Education Act of 
1986 (15 U.S.C. 4403 (a)(1)) shall be maintained in accordance with the 
Records Control Schedule of the Centers for Disease Control and 
Prevention (CDC).

12. Violation

    Misuse or loss of privileged information constitutes a violation of 
statutory provisions and HHS rules for controlling and protecting such 
information. Employees failing to comply with the provisions of these 
Guidelines or other established document control procedures are subject 
to action commensurate with the seriousness of the violation.

Attachment A--Commitment to Protect Confidential Information on the 
Ingredients Added to Tobacco in the Manufacture of Smokeless Tobacco 
Products

    Whereas access to confidential information in the files of the 
Public Health Service is required in the performance of official 
duties, I ________________________ on this ________ day of 
________________ 19__, hereby agree that I shall not further 
release, publish, copy, or disclose such information, and that I 
shall protect such information in accordance with the provisions of 
5 U.S.C. 552(b)(4), and the Public Health Service guide for the 
Control of Confidential Information on the Ingredients Added to 
Tobacco in the Manufacture of Smokeless Tobacco Products.
    I understand the provision of 5 U.S.C. 552(b)(4), and the PHS 
guide, and that I am subject to penalties prescribed by law for any 
violations thereof.
Signed:----------------------------------------------------------------
Date:------------------------------------------------------------------
Witnessed by:----------------------------------------------------------
Date:------------------------------------------------------------------

Attachment B--Receipt for Confidential Information in the Manufacture 
of Smokeless Tobacco Products

To: Director, Office on Smoking and Health, Centers for Disease 
Control and Prevention (CDC), Atlanta, Georgia 30341-3724.
From:------------------------------------------------------------------

    Receipt of the following privileged information is hereby 
acknowledged: File#--Description of Information--Anticipated 
Date of Return.
Date:------------------------------------------------------------------
Signature:-------------------------------------------------------------

Attachment C--Authority to Remove Confidential Information on the 
Ingredients Added to Tobacco in the Manufacture of Smokeless Tobacco 
Products

____________________ (name) of __________________________ (government 
agency or office) is hereby granted the authority to have the following 
privileged information in his/her personal possession from __________ 
(hours), __________ (date) to __________ (hours), __________ (date).
    Describe Privileged Information:
    Document Number:
    Title:
    This information will be used for:

Authorized by: --------------------------------------------------------
Director, Office on Smoking and Health

Date: -----------------------------------------------------------------

[FR Doc. 94-2184 Filed 1-31-94; 8:45 am]
BILLING CODE 4160-18-P