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9/17/2015
12
First Conclusion
•
With a very low contamination rate, it may
not be possible to provide a sample size that
is both of reasonable size and able to
distinguish between a “normal”
contamination rate and something that is a
couple orders of magnitude higher.
•
But did not examine alternatives to a
sampling plan that accepts with no positives
and rejects with 1 positive
−
e.g., accepts with 1 positive and
rejects with 2, or different AQL/RQL
FD&C Act Section 402. Adulterated Food
“A food shall be deemed to be adulterated
(a)(1) “If it bears or contains any poisonous
or deleterious substance which may render
it injurious to health;
but in case the substance is not an added
substance such food shall not be considered
adulterated under this clause if the quantity
of such substance in such food does not
ordinarily render it injurious to health.”