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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.”