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  3. Finally, Some Sanity About Roundup

Finally, Some Sanity About Roundup

August 10, 2019 in In The News

Drug & Device Law Blog | James M. Beck

The Environmental Protection Agency, which has jurisdiction over product labeling for Roundup/glyphosate has taken steps to enforce its prior no-carcinogen finding.  In a formal letter dated August 7, 2019, has rejected any carcinogen labeling:

Given EPA’s determination that glyphosate is “not likely to be carcinogenic to humans,” EPA considers the Proposition 65 language based on the chemical glyphosate to constitute a false and misleading statement.  As such, pesticide products bearing the Proposition 65 warning statement due to the presence of glyphosate are misbranded pursuant to section 2(q)(1)(A) of FIFRA. . . .  The warning statement must be removed from all product labels. . . .

EPA “Dear Registrant” letter, at 1-2.  EPA thus “disagrees with the IARC’s assessment of glyphosate,” id. at 1, and in the United States, the EPA has the requisite legal authority to govern product labeling.

Further, given the EPA’s action, all the civil litigation should be preempted under the Supreme Court’s recent decision in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).  Albrecht deals with implied preemption, so its holdings apply equally to other regulatory regimes besides the FDCA – just as, in the other direction, the “genuinely equivalent” standard for parallel claims originating in FIFRA, see Bates v. Dow Agrosciences LLC, 544 U.S. 431, 454 (2005), has applied to FDCA-regulated products.

Click here to read more.

December 19, 2019
Regulators
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Five-Point Plan to address potential future Roundup™ claims

Bayer today provided an update on its five-point plan to address future Roundup™ litigation risk after its May 27th decision to withdraw from the national class process. The company is now in more control of important aspects of the risk mitigation process and has sketched out two basic scenarios going forward to provide a path to closure of this litigation. The first scenario is based on obtaining a favorable decision by the United States Supreme Court on a cross-cutting issue like federal preemption which would effectively and largely end the U.S. Roundup™ litigation. The second scenario assumes that the Supreme Court either declines to hear the Hardeman case or issues a ruling in favor of plaintiff – in that case the company would activate its own claims administration program.

Read about the five-point plan here.

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