PPC Submits Scientific Policy Comments

July 28, 2021

Dr. Eric S. Lander, Director
White House Office of Science and Technology Policy
Executive Office of the President
Eisenhower Executive Office Building
1650 Pennsylvania Avenue
Washington, D.C. 20504
Submitted via e-mail to: ScientificIntegrityRFI@ostp.eop.gov

Dear Dr. Lander,
The PPC is an organization of food, agriculture, forestry, pest management and related industries, including small businesses/entities, which are dependent on the availability of pest management tools. PPC members include nationwide and regional farm, commodity, specialty crop, and silviculture organizations; cooperatives; food processors and marketers; pesticide manufacturers, formulators and distributors; pest and vector-control applicators and operators; research organizations; equipment manufacturers and other interested stakeholders. PPC serves as a forum for the review, discussion, development and advocacy around pest management regulation and policy.

PPC members confront changing pest and disease threats introduced into the United States via weather, trade, and other factors.  Pesticide manufacturers work diligently to make pest control products available through, among other entities, a web of seed, fertilizer, and pesticide distributors, transportation networks, and pesticide application services.  These efforts help ensure farmers, ranchers, public health officials, and other pesticide applicators have the tools they need to continue to produce America’s food, fiber, and biofuel and to protect our public health and infrastructure.  Many of these participants are small businesses reliant on annual, time-sensitive sales and labor to support American agricultural production and small businesses.

In this RFI response, the PPC comments are based mostly on our experience as stakeholders impacted by science policies and decisions made by Federal agencies involved in the regulation of pesticide products, whose decisions affect the agricultural, forestry, turf, and structural pest control industries.  Pesticide product use is affected by the activities of various agencies, including the Environmental Protection Agency (EPA), the Food and Drug Administration FDA), the National Marine Fisheries Service (NMFS), the Fish and Wildlife Service (FWS), and the US Department of Agriculture (USDA).
 
1.    The effectiveness of Federal scientific integrity policies in promoting trust in Federal science.

Policies that support transparency, inclusion, and the opportunity to interact with scientific reviewers advance stakeholder understanding and acceptance of science decisions made by Federal agencies. When the public, industry, academics, research institutions, and other interested parties can interact with scientific reviewers and provide their perspectives and relevant information, the credibility of decisions based on such science assessments is enhanced. 

For the PPC, when assessing decisions made by EPA according to the implementing regulations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), affected stakeholders need to understand the basis of EPA decisions, in terms of the underlying science, sound risk assessment approaches, and proper application of the FIFRA requirements.  When agencies explain how the science supports a decision, following established regulations and scientific review practices, scientific integrity and trust in regulatory outcomes are advanced.

Government policies should encourage Agencies to use plain and accessible language to describe their process for considering sources of scientific data, and to discuss the robustness and level of certainty in data and risk assessments supporting regulatory actions. 

Agencies should provide clear and understandable descriptions of the risk assessment methods used, how they accounted for scientific uncertainty, and the criteria applied to balance risks to advance trust in the underlying regulatory decision. Science-based agencies should provide plain-language summaries of proposed and final risk assessment and decision documents, including clear explanations of data quality and reliability criteria, and descriptions of how and whether those criteria are satisfied by the data, scientific studies, and literature relied upon. 

A consistently troubling PPC concern regards the “compounding conservatism” which underlie many scientific models used in EPA regulatory assessments.  The basis of decisions can remain opaque when modeling estimations are used instead of field monitoring data (even when provided by sister Federal agencies).  Transparency around when and how data from stakeholders is (or is not) incorporated into scientific risk assessments would be helpful.  The credibility of decisions would be improved if greater resources could be devoted to narrow the uncertainty around decisions with more refined assessment methods that more accurately reflect realistic, “real-world” conditions.

Policies that require science to be reproducible, including making the data and results available, also will advance trust in the underlying science.  When decisions are based on study results that are withheld from public review or are not reproducible, the confidence of affected stakeholders in the scientific honesty behind the decision is eroded.
 
Scientific integrity should encompass policies to support agency adoption and incorporation of emerging science, and require science-based agencies to review and revise risk assessment models, tools, guidelines, and policies to reflect new developments in science and technology.  Policies regarding the recruitment and pay of Federal personnel also affect the ability of an agency to maintain the scientific quality of work products.  Personnel policies should also stress the need for continuous training to enable staff to constantly reflect the latest and best capabilities in the respective fields of expertise.  

2.    Effective policies and practices Federal agencies could adopt to improve the communication of scientific and technological information.

Clear and concise communication of scientific and technical information about science issues is essential for building awareness and understanding of Federal science decisions. Translating complex scientific work into accessible web pages, fact sheets, and social media posts requires personnel trained in risk communication, data visualization, and infographics. 

The PPC encourages and supports practices that promote hiring science and risk communication professionals into science-based Agencies.  In addition, risk and science communication training for scientists can advance scientific integrity by increasing the ability of Agency experts at all stages of their careers to be able to answer questions, explain decisions, and increase trust in Agency science to a variety of audiences clearly, correctly, and confidently.att 

The science communication skills of the Federal workforce are increasingly important, as complex innovations in biotechnology, nanotechnology, application technology, and other advanced science approaches permeate modern agricultural production, crop protection, and public health protection (many pesticide products have public health uses, as much of the public came to rely on new COVID-related pesticide products).

3.    Effective policies and practices Federal Agencies could adopt to address scientific issues and the scientific workforce.

In addition to personnel recruitment and training, Agencies should find ways to retain scientific staff and expand existing policies that require routine scientific workforce training on scientific integrity principles.  This training should be accompanied by consistent messaging from top Agency leadership on the importance of scientific integrity and maintaining the highest level of scientific competence for all relevant staff positions. 

Policies and practices should further the scientific workforce attending educational programs to obtain experience with and exposure to emerging scientific tools and developments. Such training and exposure also will promote retention of scientific talent.  Many excellent training programs exist through academic partnerships, internal agency mentorship and coaching programs, and opportunities for Federal scientists to detail to other science-based Federal agencies.

The technological capability of science-based agencies should be on par with the private sector and with global trading partners.  Acquisition of cutting-edge technology will ensure that U.S. science-based agencies are global leaders in science and technology.

4.    Effective practices Federal agencies could adopt to improve training of scientific staff about scientific integrity and the transparency into their scientific integrity practices.

Often scientists may disagree with the program leadership, sometimes leading to allegations that scientific integrity has been breached.  Clear delineations can be made between a management decision and a violation of scientific integrity.  Transparency about how and why decisions are made (including explanations internal to the agency) can reduce confusion about what is a disagreement over “science” and what is a management decision based on other relevant and lawful considerations.  

Regulatory decisions, even if steeped in science, need to take account of other factors relating to the underlying legislative mandate that can include food security, protecting public health, trade obligations, and national interests.  It should not be considered lack of integrity if appropriate legislative or other programmatic considerations leads to an outcome about which some scientific staff may disagree.  Program management on such occasions will also benefit by clear adherence to scientific assessment review procedures and policy guidance established by open, reliable, and consistent methods as outlined earlier.

At the same time, resolution of any internal disagreements about scientific interpretations should minimize delays in finalization of important regulatory decisions and policies.  

5.    Other important aspects of scientific integrity and effective approaches to improving trust in Federal science.

Peer review panels are a critical additional source of scientific expertise for Federal agencies. We support scientific integrity policies that recognize that scientists from all backgrounds – non-governmental organizations, academia, and industry – are valued in peer review, and that bias will not be presumed solely because of the scientists’ employer. Policies supporting balanced peer review panels that consist of a breadth of expertise with scientists from all backgrounds will advance trust in their work. 

The goal is to have peer review policies that insulate review procedures from political changes, as independent panels make for greater integrity and credibility of the decisional outcome.  At the same time, some agencies appear to exert influence to support tentative agency decisions through the selection of panel members or the wording of questions before review panels.  A further concern is that at times the final summary report of some review committees, often drafted or interpreted by agency staff, seem to be inconsistent with the real-time proceedings according to those who attend or participate in the review meetings.  

Transparency and openness, discussed earlier, are ways to combat even subtle bias that might permeate the selection of review panel members or agency-drafted conclusions summarizing independent reviews.

Thank you for the opportunity to comment on these important issues.

Sincerely,
 
Steve Hensley
Chair, Pesticide Policy Coalition

Beau Greenwood 
Vice Chair, Pesticide Policy Coalition