MAJOR DEVELOPMENT EFFECTING ROUNDUP By John Ray

Montana Federal District Court (4:21-cv-00003-BMM) took less than thirty days to strike down Trump-era EPA rule, “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information,” 86 Fed. Reg. 469 (Jan. 6, 2021) after Biden EPA offers no contest to relief sought by Plaintiffs (other similar cases stayed due to Biden EPA’s position). The rule would have been more aptly named, “The EPA can ignore and/or cherry pick science.”

The Montana Federal Court ruling should put an end to the EPA’s long-standing practice of engaging in willful scientific illiteracy, in which the EPA cherry picks the scientific literature it considers when clearing labeling for herbicides and pesticides, absent warnings of specific diseases and injuries shown by the weight of the scientific literature to be caused by a specific product.

If history is to record a single positive outcome from the Trump Presidency, that outcome may very well be the administration’s having taken a common and long-standing EPA practice, one step too far, giving the Judicial branch the opening it needed to put an end to the practice altogether.

The Montana ruling, as well as the Biden EPA’s position (essentially agreeing with Plaintiffs) is a significant positive development for Plaintiffs in the RoundUp, the emerging Paraquat Litigation, and is likely to contribute to MTN’s prior predictions becoming reality. More on the Montana case and the impact on RoundUp and other litigations later in this article..

MTN AND OTHERS PREDICTED THIS

MTN, as well as others, predicted (and hoped) that the Biden administration would roll back the EPA’s 2020 “ruling” on Glyphosate, which has been a major weapon for Defendants in settlement negotiations, as well as preemption arguments in the RoundUp litigation.

It appears that our predictions are in the process of coming true and in a fashion with much further reaching implications than expected.

(In a forward-looking prediction) MTN recently stated that we believed that litigation involving FIFRA-regulated products (pesticides, herbicides, etc.) would become as common as drug and medical device litigation. MTN has conducted two Whiteboard Wednesday sessions on this topic in the last month, with a specific focus on Paraquat.

First time attendees and returning Alumni of MTN’s upcoming Four Day Immersion Couse (June 11th-June 14th) will enjoy the benefits of a “deep dive” into all things FIFRA litigation as we intend to use this topic as a teaching tool in the June course.

EPA CHERRY PICKING DID NOT BEGIN WITH TRUMP

There is no better example of the dichotomy found in EPA determinations versus other authorities’ findings regarding the injuries and diseases potentially caused by a FIFRA-regulated product than is shown in a comparison of the CDCs statements, which list a host of injuries and diseases caused by Paraquat. Conversely, EPA-cleared Paraquat labels do not warn of any of the more serious injuries and diseases listed by the CDC.

MTN predictions arose from five primary beliefs/theories:

  1. The EPA has engaged in “cherry picking” scientific evidence for decades, clearing labels for FIFRA-regulated products that fail to warn of injuries and diseases for which an honest and rational review of the scientific literature would require. The EPA had “gotten away” with this practice for years, largely due to a lack of significant media and public attention.
  2. The Trump EPA arguably expanded the EPA’s practice of engaging in intentional scientific illiteracy. There is no better example of the foregoing than the EPA’s actions related to glyphosate (RoundUp), which provided one of the most potent playing cards available to defendants in the RoundUp litigation (including in settlement negotiations).
  3. In order to go further down the rabbit hole of intentional scientific illiteracy than at any time before, it was necessary for the Trump EPA to change its rules (vs hoping that its rulings did not draw much attention) to formally make the long-employed practice of “scientific cherry picking” lawful, or at least have the appearance of being lawful.
  4. MTN believed, that if Trump did not get reelected, the referenced Trump-era EPA rule change would be rolled back by Biden (or any Democrat that was elected), or declared unlawful by a Federal Court.
  5. That if #4 occurred via litigation (Judicial Ruling), the EPA would not only no longer be able to enforce the Trump-era rule, but the agency would also have to cease the practice of cherry picking the science altogether.

More simply stated, the EPA got away with cherry picking the science for years, the Trump EPA took it too far, the Courts stepped in, now the EPA will no longer be able to go back to the lighter version of intentional scientific illiteracy employed pre-Trump.

The foregoing coupled with the fact that:

  1. Through a twist of temporal fate, every single Restricted Use Pesticide (all RUP FIFRA regulated products) is up for the mandatory 15-year labeling and science review the EPA is required to conduct by law. The EPA, now absent the ability to cherry pick the science and rubber stamp the labels submitted by the makers of FIFRA regulated products, the EPA will have little choice but to order new and additional warnings regarding specific diseases shown to be caused by specific products, by an honest and complete review of the scientific literature.
  2. The Montana ruling should arguably cause the EPA to voluntary withdraw all statements/rulings and labels approved post the implementation of the Trump era unlawful rule (including Round Up) and issue new rulings statements, approvals (and disapprovals) based on an honest and complete review of the scientific literature.

DOES THE MONTANA ACTION MOOT THE TRUMP EPA’s ROUNDUP RULING?

In as much as the Trump EPAs Round Up Ruling (Interim Ruling/ Statement in January 2020) required the authority found in “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information,” now declared unlawful, the Montana ruling arguable moots the Trump EPAs action, rulings, statements etc. related to Round Up. Any act arising form or depending on a predicate unlawful act, can itself be considered lawful. Stated another way, in that the EPA cannot rely on, “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information,” 86 Fed. Reg. 469 (Jan. 6, 2021) to support the method and process by which the agency arrived at its conclusions leading to the Glyphosate ruling/statement, the agency has no basis to claim the Glyphosate ruling was made within the lawful authority of the EPA. Additionally, having conceded the fact that the Trump EPA exceeded in lawful authority in implementing, “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information,” 86 Fed. Reg. 469 (Jan. 6, 2021), the Biden EPA would not be likely be so hypocritical as to challenge any contest to the Glyphosate ruling or others dependent on the former.

Now it appears that the Trump EPA’s attempt to play “Fairy God Mother” to Bayer/Monsanto may have long term negative impact for the Big Pharma/Big Aggie player. Absent the past scientific practices previously engaged in by the EPA (for decades), the agency is likely to have no choice but to require Bayer/Monsanto and other such entities, to add long overdue specific warnings to their FIFRA-regulated product labels.” New warnings lead new failure to warn litigation.”

WHY DID BAYER/MONSANTO NEED THE EPA RULING ON GLYHOSPHATE

See 40 CFR § 152.46 – Notification and non-notification changes to registrations. and 40 CFR § 152.81 – Applicability

“A modification to registration of a currently registered product that may be accomplished under the notification or non-notification provisions of § 152.46 and any procedures issued thereunder. Notwithstanding the preceding sentence, compliance with this subpart is required if the Administrator has, by written notice under § 152.46, determined that the modification may not be accomplished by notification or non-notification. 40 CFR § 152.81 (b)(5)”

Prior to 2014, the language of 40 CFR § 152.81 left wiggle room for defendants to argue that FIFRA precluded makers of FIFRA regulated products from making unilateral changes to their product labels (like the CBE process and NDA drugs). Defendants took advantage of the lack of clarity in § 152.81 and convinced many courts that changes to their labels could only be made with the prior approval of the EPA. In 2014, the EPA changed § 152.81 to make it clear that changes under § 152.46 be unilaterally made by registrants so long as the EPA had not specifically and expressly ruled that the given change could not be made. The only other general restriction is that the change can not serve to “negatively impact the environment” per § 152.46.

Bayer/Monsanto in all probability was keenly aware of the changes in § 152.81 and thus needed the EPA to make an express statement holding that they could not add a warning related to Non-Hodgkin’s Lymphoma to their Round Up labeling.

Despite the contrary findings of some Courts, FIFRA never prevented Bayer/Monsanto from unliterally making changes to their label to include a warning of a link between the product and Non-Hodgkin’s Lymphoma.

Bottom line: The SCOTUS reasoning in Wyeth v. Levine, 555 US 555 – Supreme Court 2009 directly applies to 40 CFR § 152.46 and 40 CFR § 152.81. Additionally considering the SCOTUS jurisprudence found in in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 – Supreme Court 2019, no merit could be found in a defense argument that the EPA would not have allowed a label change, if the defendant never attempted to make the change via the unilateral authority that defendant enjoys under 40 CFR § 152.46 and 40 CFR § 152.81.

THE MONTANA RULING

“The Court declares that EPA unlawfully made the Final Rule effective immediately on publication in the Federal Register, Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information 86 Fed. Reg. 469 (Jan. 6, 2021); and The Court declares, therefore, that the Final Rule is ineffective until 30 days from its January 6, 2021, date of publication in the Federal Register.”

On April 30, 2018, The Trump EPA invoked 5 U.S.C. § 301 “general housekeeping rule” to propose and implement the challenged rule:

5 U.S.C. § 301 holds that: The head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. This section does not authorize withholding information from the public or limiting the availability of records to the public.

5 U.S.C. § 301 is not a mechanism for an agency to circumvent 5 U.S. Code § 553 – Rule making when the changes being implemented are clearly not within the scope of § 30.

These are some of the Plaintiffs who also brought cases seeking the same relief sought and granted by the Montana Court. STATE OF NEW YORK, STATE OF CALIFORNIA, STATE OF CONNECTICUT, STATE OF DELAWARE, STATE OF ILLINOIS, STATE OF MAINE, STATE OF MARYLAND, COMMONWEALTH OF MASSACHUSETTS, PEOPLE OF THE STATE OF MICHIGAN, STATE OF MINNESOTA, STATE OF NEW JERSEY, STATE OF NEW MEXICO, STATE OF NORTH CAROLINA, STATE OF OREGON, COMMONWEALTH OF PENNSYLVANIA, STATE OF VERMONT, STATE OF WASHINGTON, STATE OF WISCONSIN, KING COUNTY WASHINGTON, CITY OF CHICAGO, CITY OF LOS ANGELES, and CITY OF NEW YORK