Chemicals, Regulatory Developments

EPA Ignored Policy and Procedures for Dicamba Registration

In a report dated May 24, 2021, the EPA Office of Inspector General (OIG) determined that the Agency “deviated from typical procedures in its 2018 Dicamba pesticide registration decision.”

EPA dicamba registration

The watchdog report found required internal peer reviews were not conducted for three dicamba pesticide products.

“While division-level management review is part of the typical operating procedure, interviewees said that senior leaders in the [Office of Chemical Safety and Pollution Prevention’s (OCSPP)] immediate office were more involved in the dicamba decision than in other pesticide registration decisions,” according to the IOG report.  “This led to senior-level changes to or omissions from scientific documents.  For instance, these documents excluded some conclusions initially assessed by staff scientists to address stakeholder risks.  We also found that staff felt constrained or muted in sharing their concerns on the dicamba registrations.”

Additionally, the Agency’s action led to legal vulnerability “resulting in the Ninth Circuit Court of Appeals vacating the 2018 registrations for violating FIFRA by substantially understating some risks and failing to acknowledge others entirely,” according to the OIG report.

Dicamba History and Litigation

Many pesticide products contain dicamba.  It is primarily used on soybean and cotton crops as a weedkiller. It has been the subject of high-stakes lawsuits by farmers whose lands sit adjacent to farms using the pesticide.  Attorneys in many of these suits were successful in proving winds carried dicamba onto the adjacent lands and killed the crops.

“Farmers have been using dicamba for more than 50 years, but after Monsanto–which was bought by Bayer in 2018–released dicamba-tolerant cotton and soybeans, the herbicide’s use became more widespread,” notes the Seattle Times. “In February 2020, Bayer and BASF were ordered to pay $265 million to a Missouri peach farmer who said the herbicide drifted from nearby cotton fields and damaged thousands of his trees.

“Bayer said in June that it would pay up to $400 million to settle claims of dicamba drift.  But Paul Lesko, a St. Louis attorney who is handling several dicamba cases, said the new EPA report could open the way for new litigation.

“Anybody that doesn’t settle or for cases going forward, I think it’s a big deal,” Lesko said. “I think it shows that punitive damages are back in play.”

Regulatory Background

The EPA’s authority to regulate pesticides comes from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which charges the EPA with regulating pesticides to prevent “unreasonable adverse effects on the environment” and defines that as:

  • “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or
  •  “a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act.”

The EPA website says the Agency evaluates “information from all kinds of sources–pesticide companies, other governments, academia, and the published scientific literature.  EPA scientists and analysts carefully review these data to determine whether to register (license) a pesticide product for use and whether specific restrictions are necessary.”

Pesticide Registration Process

Pesticide registrations are extraordinarily complex and are handled by the Office of Pesticide Programs (OPP) within EPA’s OCSPP.  Registration decisions are drafted by the OPP’s Registration Division after considering the risk assessment results conducted by “by the OPP’s Environmental Fate and Effects Division (EFED) and the OPP’s Health Effects Division, as well as analysis conducted by the OPP’s Biological and Economic Analysis Division (BEAD), according to the OIG full report.  “The Registration Division also reviews the draft language submitted by the registrant that appears on each proposed pesticide label and determines whether the directions for use and any other restrictions are adequate to warrant approving the registration.”

EFED conducts two tiers of peer reviews: the first by the risk branch that completes the assessment, and the second peer review is conducted by the EFED review panel.

The chair of the EFED review panel has substantial authority in determining the amount of substantive or major comments in response to the review of the risk assessments.

“According to the EFED update memorandum, the review panel chair is responsible for ‘recording the panel’s direction and chemical team responses as a final report of review panel meeting decisions,’” according to the OIG report.  “The branch chief must ensure that all substantive review panel comments have been considered and adequately addressed in the revised risk assessment. … Each assessment is unique, and the level of intensity and effort allotted to any one assessment depends on a number of factors.  The level of review remains within the discretion of the appropriate branch chief.”

Any analysis committed by the BEAD division must go to the BEAD Product Review Panel (PRP).

“PRP reviews focus on the following attributes of each document: issue, methodology, assumptions, uncertainties, and conclusions,” according to the OIG report.  “These documents must be signed by the authors and the appropriate branch chief.  The final document submitted to the appropriate branch chief and the BEAD director for signature must be accompanied by the PRP summary of the comments and the authors’ responses.  If a resolution of the issues cannot be reached by the document author(s) and the branch chiefs, the issues are raised to the BEAD director.”

Dicamba Registration

In late 2016 and early 2017, the EPA issued conditional registrations for three “over the top” (OTT) dicamba products for use on dicamba-tolerant soybean and cotton crops in 34 states.  Product applications were required to comply with the appropriate state regulations.

On October 31, 2018, the EPA announced it would extend the three conditional registrations until December 20, 2020.  This extension was the cause of four advocacy groups filing suit to have the court review the Agency’s decision.  On June 3, 2020, the Ninth Circuit Court of Appeals found that the EPA’s conditional registration for the three OTT products violated FIFRA, and the court vacated the three registrations.

The court noted that the EPA:

  • “[P]urported to be agnostic as to whether formal complaints of dicamba damage under-reported or over-reported the actual damage, when record evidence clearly showed that dicamba damage was substantially under-reported.
  • “[R]efused to estimate the amount of dicamba damage, characterizing such damage as ‘potential’ and ‘alleged,’ when record evidence showed that dicamba had caused substantial and undisputed damage,” according to the OIG report.
  • Failed to acknowledge:
    • “Record evidence showing the high likelihood that restrictions on OTT dicamba application imposed by the 2018 label would not be followed.
    • “The substantial risk that the registrations would have anticompetitive economic effects in the soybean and cotton industries.
    • “[T]he risk that OTT dicamba use would tear the social fabric of farming communities,” according to the OIG report.

Scientific Integrity Policy

The EPA’s Scientific Integrity Policy was issued in 2012 and states that “[t]he Agency’s ability to pursue its mission to protect human health and the environment depends upon the integrity of the science on which it relies.  Policies and decisions must be grounded in sound, high quality science.”

To foster this culture, the Policy’s actions and ideas include the following:

  • “Political or other officials should not suppress or alter scientific findings when operating a science and regulatory agency like the EPA.
  • “Reviews by Agency managers and other Agency leadership regarding the content of a scientific product are to be based only on scientific quality considerations.  For example, they should review whether the methods used are clear and appropriate and the presentation of results and conclusions is impartial.
  • “Managers and other Agency leadership are prohibited from intimidating or coercing scientists to alter scientific data, findings, or professional opinions.  In addition, policy makers shall not knowingly misrepresent, exaggerate, or downplay areas of scientific uncertainty associated with policy decisions.”

Per the policy, every EPA employee is required to report any indication of wrongdoing or irregularities to the OIG.  Additionally, EPA administrators have historically reaffirmed their commitment to transparency in the Agency’s actions, including former Administrator, Andrew Wheeler and current Administrator, Michael Regan.

OIG Dicamba Registration Deviation Report Specifics

The OIG report concluded “the EPA’s 2018 dicamba pesticide conditional registration decision varied from the OPP’s written standard operating procedures, namely because the EPA did not conduct the required internal peer review of scientific documents created to support the dicamba decision.  While OPP division-level management review is part of the typical operating procedure, staff scientists indicated that, in this instance, senior leaders in OCSPP’s immediate office—specifically the former deputy assistant administrator, former deputy assistant administrator for Law and Policy, and former acting principal deputy assistant administrator … —were more involved in the dicamba decision than in other pesticide registration decisions.  This led to senior-level changes to or omissions from scientific documents, including omissions of some conclusions addressing stakeholder risks.”

Other particulars in the report included:

  • “According to one scientist, OCSPP senior management and policy makers decided to use plant height as the standard measure of dicamba effect on plants.  This varied from the EPA scientists’ recommended approach to use visual signs of plant injury—an approach used in academic and registrant direct-spray toxicity studies, in field studies evaluating off-field movement, and in information reported in state investigations of dicamba damage.  This direction by senior management changed the division’s scientific conclusions.
  • “According to another scientist, OCSPP senior management provided direction to use registrants’ data for reported dicamba damages instead of OPP divisional data sources.  In its ruling to vacate the dicamba registrations, the Ninth Circuit Court found the dicamba damages to be substantially understated.  Divisional scientists told us their original source data would have addressed the court’s concerns.
  • “Multiple scientists in one division reported, and emails confirmed, that after OCSPP senior management review, scientists were provided with an outline from the assistant administrator’s office for rewriting their benefits and impact analysis document.  The outline removed several sections of the original document which the scientists said were relevant based on the analysis they completed.”

OIG Recommendations

The OIG report included three recommendations to correct this issue:

  1. Implement a procedure requiring senior managers or policy makers to document changes or alterations to scientific opinions, analyses, and conclusions in interim and final pesticide registration decisions and their basis for such changes or alterations.
  2. Require an assistant administrator-level verification statement that Scientific Integrity Policy requirements were reviewed and adhered to for pesticide registration decisions that involve the immediate office.
  3. Annually conduct and document training for all staff and senior managers and policy makers to affirm the office’s commitment to the Scientific Integrity Policy and principles and to promote a culture of scientific integrity.

As of the date of the report, recommendations 1 and 3 are considered resolved with corrective actions pending.  Recommendation 2 is unresolved.

For recommendation 1, the Agency proposes for the OSCPP to “develop standard operating procedures or formal best practices on ensuring scientific integrity in pesticide regulatory decisions.  The OCSPP said that the procedures or practices will ensure clear documentation and communication on material changes made by those outside of the authoring OPP division.”

Regarding recommendation 2, the OCSPP office noted that only 5% of pesticide registrations rise to the level requiring an assistant administrator-level review.  Requiring the Agency to provide verification statements from an assistant administrator for all pesticide registration would create undue inefficiencies for the office.  The OIG agreed with this statement and revised its recommendation “to focus on those pesticide registration decisions that involve senior management, defined earlier in our report to include senior leaders in the OCSPP’s immediate office.”

In response to this revision, “the Agency proposed that the OCSPP assistant administrator annually issue a memorandum to all OCSPP staff and management to affirm the office’s commitment to the Scientific Integrity Policy and to establish clear expectations of behavior to uphold scientific integrity.  This does not address the intent of our revised recommendation to require an assistant administrator-level verification statement on adhering to Scientific Integrity Policy requirements for those specific pesticide registration decisions that involve senior management.”  As such, recommendation 2 remains unresolved.

The Agency agreed with recommendation 3 in its entirety and this recommendation is considered resolved pending corrective action.

“The dicamba incident described in this draft report did not occur due to a lack of awareness of or training on the agency’s scientific integrity policy,” says Michal Freedhoff, principal deputy assistant administrator, Office of Chemical Safety and Pollution Prevention, according to Government Executive.  “It occurred because [the office’s] past senior leadership consciously chose to advance a policy outcome in a manner inconsistent with the scientific integrity policy.”

Freedhoff promised “a new approach going forward at EPA, saying scientific conclusions ‘must be based exclusively on scientific (not policy) considerations’ and her office was in the process of ‘emphasizing these points to all our managers,’” according to Government Executive.