Food and Drug Administration, HHS.
Notice; request for comments.
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).
Submit electronic or written comments by January 8, 2010.
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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Anne Kirchner, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 301-796-4800, Anne.Kirchner@fda.hhs.gov.End Further Info End Preamble Start Supplemental Information
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 Start Printed Page 65130United 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:
◦ Federal, State, and local laws prohibiting youth access to tobacco.
◦ The health and societal costs of tobacco use as the basis for youth access laws.
◦ Company policies on youth access to tobacco.
◦ The definition of tobacco products covered by youth access laws.
◦ Laws and company policies on requiring identification, including the age that triggers ID verification and the acceptable forms of ID.
◦ 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.
◦ 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.
◦ 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:
◦ Asking for ID.
◦ When and how to ask for a second ID.
◦ Declining a sale when the customer has no ID or when the ID shows the customer to be underage.
◦ Declining a sale because of concerns about whether the ID has been altered.
◦ Declining purchase attempts by a minor made with written parental permission.
◦ Resisting customer pressure.
◦ 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.
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.Start Signature
Dated: December 3, 2009.
Assistant Commissioner for Policy.
[FR Doc. E9-29288 Filed 12-8-09; 8:45 am]
BILLING CODE 4160-01-S