richard g. higby, ph.d. president arista laboratories, inc
TRANSCRIPT
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Acceptable Analytical Methods for Assessing the Quantity of Each
ConstituentRichard G. Higby, Ph.D.
PresidentArista Laboratories, Inc.
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1. Analytical methods should not be prescribed by law
2. A defined quality system is necessary3. Machine smoking conditions must be clearly
defined4. Replicate requirements need to be explicitly
stated
Key Points
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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
Analytical methods should not be prescribed by law
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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
A defined quality system is necessary
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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
Machine smoking conditions must be clearly defined
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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
Replicate requirements need to be explicitly stated
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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
Conclusion