The following questions are those most commonly asked about the Synar Regulation and its implementation. They are included here for easy reference.

1.  Who is required to comply with the Synar Regulation?

All 50 States and 9 jurisdictions (including the District of Columbia) are required to comply with the Synar Regulation. However, because legislatures in several States were not scheduled to convene during 1993 or 1994 following the passage of the Synar law, some States were given a 1-year delay. These seven States (termed "delayed applicability States") are Arkansas, Kentucky, Montana, Nevada, North Dakota, Oregon, and Texas. The delayed applicability States are required to be in complete compliance with the law by FFY 97 and report baselines and targets in their FFY 98 block grant applications.

2.  What was the national rate of sales of tobacco products to minors prior to the release of the SAMHSA Implementing Regulation?

Data on tobacco sales to minors before passage of the Synar Amendment come predominantly from local evaluations of youth access interventions, and thus provide city or county (rather than State or national) sales rates. In addition, youth tobacco purchase surveys conducted prior to the release of the SAMHSA Implementing Regulation often differ substantially from the random, scientific surveys conducted for SAMHSA in terms of sampling procedures and the inspection protocols used to assess retailer compliance.

With these methodological differences in mind, studies of the rates of tobacco sales to minors prior to the release of the SAMHSA Implementing Regulation most often recorded inspection failure or noncompliance rates in the 60- to 90-percent range.

There was considerable variability in the rates of sales to minors depending on tobacco source: 32 to 87 percent for over-the-counter sales and 82 to 100 percent for vending machine sales.

3.  What is an inspection protocol?

A Synar Regulation inspection protocol is a set of procedures used to detect retailer compliance with youth tobacco access laws. Such a protocol may or may not be prescribed by State law. A cause for concern lies in the uniformity of inspection protocols across States. A lack of uniformity introduces the possibility of bias in the national sales rate. At the very least, the protocol used within each State must be consistent from year to year in order to generate results that are comparable over time.

4.  What is a valid probability sample?

A valid probability sample for the purpose of Synar Regulation inspections is a random sample that includes two key elements: (1) the sample is drawn from a universe of all outlets; and (2) each outlet has a known probability of being selected for inspection, and that probability is not zero. The requirement for a valid probability sample can be met in a number of recognized ways, depending on the circumstances and specific situations.

5.  What does the national sales rate look like now?

The differences in sampling techniques and the initial rigor that States were able to bring to sampling list frame development makes calculation of a valid "average" inspection failure or noncompliance rate unfeasible for the States. However, the median baseline rate was 41 percent.

6.  What were the baseline sales rates?

Official baseline sales rates were negotiated between SAMHSA and each State in light of the nature of the random sample survey methodology employed by the State. Baseline rates fell within the range of 7.2 percent to 72.7 percent, as shown in figure 9. Nine States reported sales rates at or below 30 percent, and eight States reported rates above 50 percent. States with lower baseline rates were found to have engaged in significant enforcement activities over a period of several years.

7.  How long will it take for all States to reach the 20-percent inspection failure or noncompliance rate?

Based on negotiations with SAMHSA, all States will reach the goal of a maximum 20-percent inspection failure rate by FFY 02. (See figure 10.) According to data reported in FFY 97 block grants, four States are already at or below 20 percent. The target levels and timetables negotiated by SAMHSA with each State have permitted all States to develop the infrastructure necessary to reduce sales of tobacco to underage youth and to begin reducing those rates within a reasonable time period. Each State has thus demonstrated its commitment to the ultimate goal of reducing tobacco use by minors, reasonably reducing the availability of tobacco products to youth, and showing immediate and sustained progress toward meeting the standards set forth in the Synar Regulation.

8.  What is preemption? Does it have any effect on minors' access to tobacco?

Preemption is an issue that refers to State tobacco control laws that include a clause barring, or pre-empting, its localities from enacting tobacco control ordinances that are stricter than the State's. preemption is often presented as a State's rights issue, but the implication for youth tobacco access is that such a statute then renders illegal any policy that individual counties and communities may wish to enact, or have already enacted, to support the health of their youth.

Preemption clauses do not usually interfere with implementing the Synar Regulation, per se. However, it is possible that as States near their final target, they may find that increasingly greater efforts are needed to achieve the 20% inspection failure goal. As that time approaches, it will become important to know whether preemption, by not allowing localities to enact stricter youth access provisions, is interfering with a State's efforts to meet the goals of the Synar Regulation. Therefore, SAMHSA is monitoring this issue.

9.  What is the current level of State compliance with the Synar Regulation?

SAMHSA has worked closely with the Single State Authorities for substance abuse and their partner agencies to build an infrastructure to meet the requirements of the Synar Regulation. As a result, there has been tremendous progress on the part of the States in complying with the new SAPT Block Grant requirements.

The Agency is pleased to report that all States (excluding the delayed applicability States) are in compliance with the basic provisions of the SAMHSA Implementing Regulation. No State is in violation of any provision. Specifically, these States:

10.  What obstacles have States encountered in their efforts to comply with the Synar Regulation, and how have they been addressed?

Enforcement: Tying the implementation of the Synar Regulation to SAPT Block Grants has created a number of serious administrative and strategic obstacles for States. Few of the block grant recipients, the Single State Authorities for substance abuse, had any enforcement authority for tobacco in their States. In addition, many State enforcement agencies designated by State law or appointed by Governors had no vested interest in enforcing State youth access laws. As a result, between 1991 and 1996, the Single State Authorities for substance abuse worked creatively and collaboratively with other State agencies to develop organizational relationships that allowed for effective enforcement of State youth tobacco control laws.

Sampling: In FFY 96, only 30 States had any form of licensure for tobacco vendors, posing a major challenge to developing complete and accurate lists of vendors from which to select a random sample. With the help of consulting statisticians provided by SAMHSA, private contractors hired by the State, and creative State authorities, new sampling techniques were developed by each State. These sampling plans were reviewed and approved by SAMHSA experts. Each sampling plan met the States' unique challenges and, at the same time, was consistent with accepted, scientific sampling protocols following the sampling design guidance document developed by SAMHSA.

Funding: The SAMHSA Implementing Regulation does not allow the allocation of Federal funds for enforcement purposes. For most States, this proved to be a significant problem because enforcement of youth access laws had not previously been viewed as a priority, and States were reluctant to redirect already limited funding for prevention and treatment services to law enforcement. Some States addressed the problem by earmarking revenue derived from licensing fees, taxes, or fines specifically for enforcement purposes. Other States have implemented a collaborative enforcement plan, such that the expense is shared among several agencies rather than shouldered by a single agency. Many States rely on the use of volunteers (e.g., youth inspectors, adult escorts) to defray the cost of conducting inspections. Many of these types of solutions require a considerable amount of activity in State legislatures and within State bureaucracies. While funding problems can be overcome, enforcement and the related reduction in sales rates may require more time in some States because of the realities of the political climate and bureaucratic structure.

11.  How has implementation of the Synar Regulation affected smoking rates?

Although the objective of the Synar Regulation is to ensure that retailers do not sell tobacco to persons under age 18, this question speaks to the long-term intent of this and other Federal initiatives to reduce youth smoking. As yet, SAMHSA does not know the answer to this question. The evaluation of the effects of the Synar Regulation will address the legislation's impact on smoking rates among youth-examining both the rate at which young people start smoking and the amount of tobacco used by young people who are already smokers. Previous research done on a smaller scale, however, suggests that enforcement supplemented by community education, media advocacy, and merchant education can reduce tobacco sales to minors and can lead to significant decreases in smoking among young people for the period immediately following enforcement. The long-term effect requires additional study.