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Acceptable Analytical Methods for Assessing the Quantity of Each Constituent

Acceptable Analytical Methods for Assessing the Quantity of Each Constituent. Richard G. Higby, Ph.D. President Arista Laboratories, Inc. Key Points. Analytical methods should not be prescribed by law A defined quality system is necessary Machine smoking conditions must be clearly defined

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Acceptable Analytical Methods for Assessing the Quantity of Each Constituent

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  1. Acceptable Analytical Methods for Assessing the Quantity of Each Constituent Richard G. Higby, Ph.D. President Arista Laboratories, Inc.

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

  3. Analytical methods should not be prescribed by law • 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

  4. A defined quality system is necessary • ISO 17025 laboratory standard • Scheduled and periodic assessments • Laboratories exist today accredited to ISO 17025 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

  5. Machine smoking conditions must be clearly defined • 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

  6. Replicate requirements need to be explicitly stated • 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

  7. Conclusion • 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

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