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A court in California ruled against companies that may have to put a warning that tells customers there is a possible cancer risk linked to coffee by saying the companies "failed to meet their burden of proof on their Alternative Significant Risk Level affirmative defense". Is this ruling justified?

This is somewhat related to this answer since it addresses the health risk of acrylamide which is the court's argument for why coffee should have the cancer risk warning. Given the convincing data in the answer I linked, I'm finding it hard to see how the court justified this ruling.

migrated from skeptics.stackexchange.com Mar 31 '18 at 12:40

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From a legal perspective, I think the ruling is reductio ad absurdum correct. California voters passed Proposition 65. Consequently, CA Health and Safety Code 25249.6 says "No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual, except as provided in Section 25249.10". Section 25249.8 mandates a list, and defines "known to the state"

A chemical is known to the state to cause cancer or reproductive toxicity within the meaning of this chapter if in the opinion of the state’s qualified experts it has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer or reproductive toxicity, or if a body considered to be authoritative by such experts has formally identified it as causing cancer or reproductive toxicity, or if an agency of the state or federal government has formally required it to be labeled or identified as causing cancer or reproductive toxicity.

Acrylamide is so listed, and has been for 18 years, reason code listed as "AB-IARC, AB-US EPA". The law does not say that "the benefits may outweigh the risks", nor does the law say anything about usual doses. There is an "escape clause", if one (the defendant) can prove that there is no effect (25249.8(b)):

An exposure for which the person responsible can show that the exposure poses no significant risk assuming lifetime exposure at the level in question for substances known to the state to cause cancer, and that the exposure will have no observable effect assuming exposure at one thousand (1000) times the level in question for substances known to the state to cause reproductive toxicity, based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for the listing of such chemical pursuant to subdivision (a) of Section 25249.8. In any action brought to enforce Section 25249.6, the burden of showing that an exposure meets the criteria of this subdivision shall be on the defendant.

The answer on Skeptics does not address the EPA finding (and the science underlying it). At this point we can only conjecture about the defense's scientific argument (the ruling is still in the works, pending feedback from parties), but the judge said "While plaintiff offered evidence that consumption of coffee increases the risk of harm to the fetus, to infants, to children and to adults, defendants' medical and epidemiology experts testified that they had no opinion on causation" and that the coffee makers hadn't presented the proper grounds at trial to prevail.

Insofar as human subjects testing of suspected carcinogens is illegal, any argument that "but this only shows that it causes cancer in rats" is legally empty: rats are a suitable proxy for humans. This is a state report addressing a potential carcinogen, 4-Methylimidazole. The report notes that to have a No Significant Risk Level finding, the substance must have less than a "daily intake level posing a 10^-5 lifetime risk of cancer". A further requirement is that "risk analysis shall be based on the most sensitive study deemed to be of sufficient quality" (whatever that is). This study mentions a previous study which was rejected because "these studies do not meet the criteria specified in Section 25703(a) because the experiments were not designed to adequately control for and examine the potential carcinogenicity of 4-MEI". Basically, Spiegelhalter's argument is too meta, and doesn't constitute a proof that acrylamide poses no risk of cancer.

If the defendants commissioned an independent scientific study to overcome earlier carcinogen findings, perhaps the study failed on technical grounds. The bar that has to be cleared is very high. The EPA regulation says that the maximum contaminant level goal for acrylamide is zero. That is the carcinogen-science basis for specific allowable levels in water supplies.

  • I realized I linked to the wrong answer in my question, I just updated it. The linked answer says there is no significant risk of cancer from acrylamide so it's still not clear to me how the ruling makes sense per Proposition 65. Is it just that the defense didn't present these facts refuting the cancer acrylamide link? – Liron Yahdav Mar 31 '18 at 20:58
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A court in California ruled against companies that may have to put a warning that tells customers there is a possible cancer risk linked to coffee by saying the companies "failed to meet their burden of proof on their Alternative Significant Risk Level affirmative defense". Is this ruling justified?

Without seeing all of the evidence and legal arguments made, there is no way to know. It comes down to the weight of the evidence in the eye of the judge.

The burden of proof for an affirmative defense generally is upon the party to the lawsuit that raises that affirmative defense. But, whether the evidence was or was not sufficient to meet that burden of proof is impossible to know without sitting through a hearing and reviewing all of the evidence presented on that issue.

Usually, appellate courts will defer to a trial judge on the question of whether a burden of proof was met unless "no reasonable judge" could have come to that conclusion based upon the evidence presented.

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