Richard G. Higby, Ph.D. President Arista Laboratories, Inc.

1. Analytical methods should not be prescribed by law 2. A defined quality system is necessary 3. Machine smoking conditions must be clearly defined 4. Replicate requirements need to be explicitly stated

 ISO methods are valuable ◦ Validated through collaborative studies ◦ Process of development is lengthy ◦ Only six methods exist today for mainstream smoke ◦ Development continues through WHO’s TobLabNet, CORESTA  Published literature methods are not “optimized” ◦ Administrative or technical errors exist ◦ Detail is often insufficient ◦ Correction conflicts with statutes  Sound principles of validation should prevail ◦ Consistent with FDA’s approach in other areas ◦ Accreditation and audits reinforce practices

 ISO laboratory standard ◦ Scheduled and periodic assessments ◦ Laboratories exist today accredited to ISO for tobacco specific work ◦ Accrediting bodies are increasingly rigorous  Good Laboratory Practices ◦ Consistent with FDA’s practice in other areas ◦ Limited tobacco specific capacity exists today ◦ Compliant equipment will be slow to develop for the tobacco smoke specialty equipment (smoking machines) ◦ Economies of scale do not exist for instrument development

 Machine smoking is not representative of human smoking behavior ◦ Allows product to product comparisons ◦ Published methods such as ISO or the Canadian intense method are well understood ◦ The ISO method does not deliver the same results as the FTC method which should be abandoned

 Tobacco is a natural product ◦ Subject to seasonal variation ◦ Variability requires a larger sample to be statistically significant  Emissions are more variable than constituents ◦ Health Canada TRR prescribes 7 replicates for emissions (smoke) ◦ Health Canada TRR prescribes 3 replicates for constituents (tobacco) ◦ FTC and Massachusetts prescribed an average of 100 cigarettes (20 replicates) for TNC which is excessive

 Time is short ◦ Establishing capacity may be a challenge if notice is short ◦ Implementing a quality system requires time to qualify personnel and equipment ◦ We encourage the early publication of the list of constituents and the testing requirements