[Federal Register Volume 74, Number 235 (Wednesday, December 9, 2009)]
[Notices]
[Pages 65129-65130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29288]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0569]


Approved Tobacco Retailer Training Program; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket to obtain information on suggested elements for approved 
tobacco retailer training programs. FDA is establishing this docket in 
order to provide an opportunity for interested parties to provide 
information and share views on elements that should be included in an 
effective retailer training program as provided for in the Family 
Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).

DATES: Submit electronic or written comments by January 8, 2010.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Anne Kirchner, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 301-796-4800, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Tobacco products are responsible for more than 440,000 deaths each 
year. The Centers for Disease Control and Prevention (CDC) report an 
estimated 60 million adults smoke cigarettes in the

[[Page 65130]]

United States, even though this behavior will result in death or 
disability for half of all regular users. Paralleling this enormous 
health burden is the economic burden of tobacco use, which is estimated 
to total $193 billion annually in medical expenditures and lost 
productivity. Curbing the significant adverse consequences of tobacco 
use is one of the most important public health goals of our time. One 
way to do this is to prevent youth from beginning to smoke. According 
to the Substance Abuse and Mental Health Services Administration's 
(SAMHSA's) National Survey on Drug Use and Health, 80 percent of adults 
who are nicotine dependent report that they started smoking cigarettes 
before the age of 18.
    On June 22, 2009, the President signed the Tobacco Control Act into 
law. The Tobacco Control Act grants FDA important new authority to 
regulate the manufacture, marketing, and distribution of tobacco 
products to protect the public health generally and to reduce tobacco 
use by minors. Section 102 of the Tobacco Control Act requires FDA to 
issue, with certain modifications, its 1996 final regulation 
restricting the sale and distribution of cigarettes and smokeless 
tobacco products (August 28, 1996, 61 FR 44396 at 44615 to 44618). The 
rule contains provisions designed to limit young people's access to 
tobacco products, as well as restrictions on marketing to curb the 
appeal of these products to minors.
    Section 103(q)(2) of the Tobacco Control Act includes two schedules 
for assessing civil money penalties against retailers for violations of 
restrictions on the sale and distribution of tobacco products, 
including restrictions on access to, and the promotion and advertising 
of, tobacco products. Under each schedule, violators are subject to 
increasing penalties for repeated violations within prescribed time 
periods. For the first three violations in a 24-month period, retailers 
with approved training programs are subject to lower penalties than 
retailers without such programs. Section 103(q)(2)(B) of the Tobacco 
Control Act defines ``approved training program'' as ``a training 
program that complies with standards developed by the [FDA] for such 
programs.''
    We are requesting comments that will inform the development of 
guidance on approved training programs. A copy of the Family Smoking 
Prevention and Tobacco Control Act is available on the agency's Web 
site at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

II. Request for Comments and Information

    We are interested in comments on the characteristics that comprise 
an effective training program for clerks selling tobacco products in a 
retail establishment. Such programs would effectively teach such clerks 
how to request and verify the photo identification of purchasers 
younger than 27 years of age and how to refuse the sale of cigarettes 
or smokeless tobacco to purchasers younger than 18 years of age. We are 
particularly interested in information about elements of current 
tobacco retailer training programs developed by trade associations, 
corporations, States and localities, as well as any studies on the 
effectiveness of these training programs in reducing retail sales of 
tobacco products to youth.
    We believe that effective retailer training programs may include 
many of the following components and we welcome input on any of these 
specific elements:
     Methods for teaching salesclerks about:
    [ctrcir] Federal, State, and local laws prohibiting youth access to 
tobacco.
    [ctrcir] The health and societal costs of tobacco use as the basis 
for youth access laws.
    [ctrcir] Company policies on youth access to tobacco.
    [ctrcir] The definition of tobacco products covered by youth access 
laws.
    [ctrcir] Laws and company policies on requiring identification, 
including the age that triggers ID verification and the acceptable 
forms of ID.
    [ctrcir] The need to closely examine ID, including an explanation 
that many illegal sales are made to minors who produce IDs showing that 
they are under the legal age to purchase tobacco products.
    [ctrcir] Verification of an ID's authenticity, including the 
features of an ID that must be checked, how to tell if an ID might have 
been altered and what an employee should do if an ID appears to be 
altered.
    [ctrcir] The fact that salesclerks are not required to make a 
tobacco sale if there is any question that doing so would violate the 
law.
     Specific age-verifying protocols designed to ensure that 
the date of birth is read, clearly understood, and compared to a 
calendar or other age verification device.
     Practical techniques for:
    [ctrcir] Asking for ID.
    [ctrcir] When and how to ask for a second ID.
    [ctrcir] Declining a sale when the customer has no ID or when the 
ID shows the customer to be underage.
    [ctrcir] Declining a sale because of concerns about whether the ID 
has been altered.
    [ctrcir] Declining purchase attempts by a minor made with written 
parental permission.
    [ctrcir] Resisting customer pressure.
    [ctrcir] Declining to sell tobacco to underage persons who are 
friends, acquaintances, and peer group members and the techniques for 
refusal.
     Methods for ensuring and documenting that employees have 
the knowledge required to comply with youth access laws.
    We also believe that effective programs would include strategies 
for initial training of new employees and refresher training for 
existing employees. We are interested in learning about programs that 
address both of these aspects, as well as information related to the 
appropriate length of time between initial and refresher training, and 
the most appropriate methods for training (e.g., in-person training, 
Web-based training, self-study). The agency will consider information 
submitted to the docket in developing guidance on approved training 
programs.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: December 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29288 Filed 12-8-09; 8:45 am]
BILLING CODE 4160-01-S