A New Day Dawning at EPA? New Memo Raises Hope

Dicamba was approved as an over-the-top herbicide on soybeans in 2018, and reports of damage from drifting dicamba quickly followed. Known for not staying where it is sprayed, dicamba volatilizes and becomes airborne, where it can damage soybeans that are not resistant to the herbicide, causing leaf-curling (shown here, Photo: Steve Smith) and yield losses.

Eaters Deserve More Complete Information About Nutrition and Health Impacts on Food Labels
Multiple lines of evidence point to consumer food choices as major contributors to diet-related disease, and poor health and fitness. In a peer-reviewed journal article published today, authors Chuck Benbrook and Robin Mesnage cite studies indicating that “Some 90% of the estimated USD 4.3 trillion in annual health care costs in the US is triggered or made worse by poor food quality and diet-related disease.” Benbrook is the founder and former executive director of the Heartland Health Research Alliance (HHRA). The authors recommend novel metrics on both the nutrient density of food, and how to more accurately and usefully characterize the degree of food processing and its impacts on public health. The article is open access in the journal Foods and entitled “Enhanced Labeling to Promote Consumption of Nutrient Dense Foods and Healthier Diets.” The core nutrient density metric is a ratio: the percent of daily nutrient needs satisfied by a serving of food relative to the percent of a 2000 calorie daily diet taken up by the serving of food. This single metric is unmatched in comprehensively reflecting the nutritional quality of food. A graphic option to convey the metric on packaging is presented in Figure 3 in the new paper: A novel graphic is presented in Figure 5 to which integrates both the nutrient density and food processing metrics and graphics in a single graphic, shown below. The impacts of ultra-processed food (UPF) on public health outcomes is among the hottest topics in nutrition, medical, and public health journals, and media coverage on food quality and health outcomes. At the request of the journal, the authors developed a video abstract that explains the paper’s goals, methods, and key findings and recommendations. The authors conclude their paper with these observations: Transparent and accurate food product-specific ingredient and nutrient composition data should determine the content of nutrition health labeling. Efforts to soften the message should be resisted in light of the overwhelming need for new food labels that help bring about substantial improvements in food nutritional quality and dietary choices. Benbrook and Mesnage’s paper builds on public comments HHRA submitted in response to the US Food and Drug Administration (FDA) proposed rule in 2023 to update the definition of the term “healthy” on food labels. The proposed role would require foods labeled “healthy” to contain minimum amounts of foods recommended by USDA’s Dietary Guidelines, and to limit saturated fat, sodium, added sugar and other less healthy nutrients. Entitled “Food Labeling: Nutrient Content Claims; Definition of Term `Healthy’”, the comments recommended new nutrition/health messaging on the front of food packaging. Co-authors of comments included the chair of HHRA’s Policy Advisory committee Dr. Kathleen Merrigan, HHRA science advisors, and other experts working on how changes in farming systems and technology can increase the nutritional quality of food: Dr. Hannah Flower, Dr. Donald R. Davis, Dr. David Montgomery and Anne Biklé. In the comments, the authors introduced “NuCal” as a name for their new system. Resources HHRA February 2023 comments to the FDA. Benbrook and Mesnage (2024). Enhanced Labeling to Promote Consumption of Nutrient Dense Foods and Healthier Diets, Foods. https://doi.org/10.3390/foods13213377 Video Abstract: “Enhanced Labeling to Promote Consumption of Nutrient Dense Foods and Healthier Diets”
HHRA Weighs in on Key Pesticide Issues Under Review by the National Organic Standards Board
HHRA and ORG-Tracker, represented by Dr. Chuck Benbrook and Dr. Brian Baker, submitted comments to the Agricultural Marketing Service at the USDA in advance of the National Organic Standards Board (NOSB) meeting in Portland, Oregon, from October 22nd to 24th, 2024. Drs. Benbrook and Baker will both attend the conference and deliver public comments. ORG-Tracker is a project carried out by HHRA. It aggregates pesticide residue data from inspections of organic farms carried out by certifiers. The tables generated by ORG-Tracker utilize the results of certifier testing to compare residue frequency and risk levels to food produced on conventional farms. The team is working to more effectively highlight gaps and challenges faced by certification agencies to answer questions like What crops should we be testing, and where? Is a pesticide residue found in an organic sample likely caused by accident, pesticide drift, or an intentional and illegal application? How can we modify organic programs to better mitigate risk? The comments delivered to the USDA discuss risk-based certification, pesticide residue testing, and policies impacting the incorporation of so-called inert ingredients in the biopesticides approved for use on organic farms. They argue for a more rigorous, comprehensive, and health-focused approach to risk oversight. Regarding residue testing, they advocate for more expansive and effective data aggregation to inform consumers and the organics community. Finally, for inert ingredients, they recommend further review of current policy, including increased transparency of ingredients in pesticide products. Thank you to Drs. Benbrook and Baker for your advocacy and hard work! The three sets of comments are posted on HHRA’s website as part of our policy program: Comments to the NOSB on the Risk-Based Certification Discussion Document Under Consideration During the October 2024 Meeting in Portland, Oregon Written Comments on the NOSB Discussion Document “Residue Testing for the Global Supply Chain” Comments on the Inert Ingredients in Organic Pesticide Products Proposal dated August 13, 2024 Drs. Benbrook and Baker also submitted and presented comments at the Spring 2024 meeting of the NOSB, which are available on HHRA’s Policy and Regulatory Reform page.
Dr. Kimberly Yolton joins HHRA board
Dr. Yolton is a developmental psychologist and epidemiologist serving as Professor of Pediatrics at Cincinnati Children’s Hospital Medical Center. Her interests include exposures and experiences that may alter a child’s developmental trajectory from infancy through adolescence. She collaborates on research projects on typical child development as well as those focused on the impact of exposures to environmental toxicants, opiates and stress during early development.
Paul Hartnett, HHRA’s Executive Director
Paul Hartnett has served as HHRA’s CFO since our founding . With the departure of Russell King, Paul has now joined the board and Executive Director. We thank Russell for his service and wish him the best in his future endeavors.
Heartland Study Enrolls 1,000th Mother-Infant Pair
July 19, 2024 – In June of this year, the Heartland Study achieved a major milestone, enrolling its 1,000th mother-infant pair. Enrollment is now at 50% of goal. The objective of the Study is to help fill major gaps in our understanding of the impacts of herbicides on maternal and infant health. Currently in Phase 1, the Study is focused on evaluating associations between herbicide concentrations in body fluids and tissue samples from pregnant women and infants, and pregnancy/childbirth outcomes. Phase 2 is designed to evaluate potential associations between herbicide biomarkers and early childhood neurological development. Much appreciation for the mothers enrolled, and the entire Heartland Study Team including scientists, support staff and clinicians for this tremendous achievement, and for our funders to making this work possible. Read more about the study including peer-reviewed studies published in Chemosphere and Agrichemicals at our publications page. The investment required to conduct this study exceeds $1 million each year. You can support this important work by making a donation here.

Reporter Emily Unglesbee with DTN/Progressive Farmer has done solid reporting for years now on the trials and tribulations of dicamba herbicide and the XtendiMax GMO soybean and cotton seeds it has been applied on since 2016.

Dicamba is one of the herbicides of intense interest to The Heartland Study science team. It is known to cause reproductive problems and certain birth defects. It has been classified as a possible human carcinogen, and likely will soon be upgraded to probable human carcinogen because of recent findings showing association with cancer from the National Cancer Institute.

The use of dicamba throughout the Heartland has skyrocketed since 2016, as a result of the approval of the GMO seeds engineered to tolerate over-the-top applications of dicamba. Our HHRA interactive herbicide use tables capture clearly just how rapidly dicamba use has grown wherever corn, soybeans and cotton make up a significant share of harvested cropland.

But problems grew in step with use. Dicamba is a highly volatile herbicide. It moves up into the air, especially when it is hot and humid. It can move miles, even hundreds of miles.

The crops, trees, vineyards, shrubs and backyard gardens where it comes back down to earth often pay a price. In short, dicamba is the acid rain of the plant world. It is a plant mutagen and is especially damaging when it lands on a crop during flowering.

On March 12, 2021, Unglesbee broke a troublesome but not unexpected story entitled “EPA: Politics Tainted Dicamba Decision — EPA Ignored Science in Past Dicamba Decision, New EPA Official Says.” It describes a message just sent to EPA employees by Michal Freedhoff, the Acting Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). In it, Freedhoff bluntly states “I am aware that political interference sometimes compromised the integrity of our science,” and goes on to list specific examples, with the first being the 2018 registration of dicamba herbicides.

The rest of the memo sent by Dr. Freedhoff speaks for itself. I have included it in its entirety at the end of this blog.

OCSPP is the part of EPA that oversees the Office of Pesticide Programs (OPP). I have worked with and watched OPP strive to identify and mitigate high-risk pesticide uses for almost 50 years. Over this span of time, the last four years stands out as a troublesome outlier during which it seemed almost no request from any pesticide registrant was deemed too outrageous to act upon.

Did you hear that there is even an effort afoot to bring back aldicarb??? The controversial insecticide was banned in 2010 due to “unacceptable dietary risks, especially to infants and young children.”

I hope Dr. Freedhoff’s memo signals a rebirth of commitment to science and integrity in decision making in OCSPP. There is much lost time, and ground, to make up.

—Dr. Charles Benbrook, HHRA Executive Director

Below is the EPA Memo in full. View as a pdf here.

Dear OCSPP Colleagues – By now, I’ve been a part of the OCSPP team for nearly seven weeks, and I continue to be deeply impressed by and grateful for your integrity, professionalism, and unmatched commitment to public service and the public good.

I have been particularly pleased to see OCSPP career professionals speak strongly in support of Scientific Integrity. As you know, science is the backbone of EPA. Scientific integrity, in turn, is a bedrock principle for President Biden, Vice President Harris, our incoming Administrator Michael Regan, and me. Scientific Integrity ensures that our science is sound and that we earn and maintain the public’s confidence in our decision-making. I affirm my commitment to you to act with scientific integrity. I expect you to do likewise when working with me and with each other.

Our work as a science-based regulatory office requires us to embody scientific integrity in many contexts. For example, I expect:

• Robust exchange of scientific views, with differing scientific opinions expressed in writing early and shared with mangers throughout the process, including me.
• Truth-telling in briefings: what do I and other managers need to know?
• Courage to point out errors early in the process and a welcoming attitude by managers and peers to those communications.
• Respect for the role of science in risk assessments and the role of policy and law in risk management decisions. This requires the assurance that risk management considerations aren’t the driving influences during the risk assessment phase, and it requires respect among scientists when difficult policy choices are ultimately made.
• Integrity of scientific products.
• Clear, real-time communication with scientists to explain senior scientists’ changes to draft scientific products and an opportunity for scientists to express a different view.
• Understanding that, as a regulatory office, we also need to be mindful of statutory and other deadlines.
• An environment – led in the first instance by OCSPP managers – where everyone feels comfortable identifying errors, asking questions, and expressing differing scientific opinions, all without fear either of retaliation or being denigrated for speaking up.
• An environment free from political interference in the science.

Over the past few years, I am aware that political interference sometimes compromised the integrity of our science. Here are examples:

2018 Dicamba Registration Decision: In 2018, OCSPP senior leadership directed career staff to: (1) rely on a limited data set of plant effects endpoints; (2) discount specific studies (some with more robust data) used in assessing potential risks and benefits; and (3) discount scientific information on negative impacts. This interference contributed to a court’s vacating registrations based on these and other deficiencies, which in turn impacted growers’ ability to use this product.

TCE: White House staff directed OCSPP career staff to alter the draft TCE risk evaluation to change the point of departure used for making determinations of risk to a less sensitive endpoint. While the risk evaluation included a description of the more sensitive endpoint (fetal heart malformations), it was no longer used to determine whether there is unreasonable risk from TCE. Unreasonable risks were nevertheless identified for most uses of TCE, but the magnitude of the risk from exposures to TCE would have been greater had EPA relied upon the fetal cardiac defect endpoint that had been used in previous EPA peer-reviewed assessments.

PFBS Toxicity Assessment: The PFBS Toxicity Assessment that was recently removed from EPA’s website included conclusions purporting to reflect science when in fact they were the product of biased political interference directed in part by OSCPP’s past political leadership. That interference undermined the agency’s scientific integrity policy and eroded the trust that the American public has in EPA, the quality of our science, and our ability to protect their health and the environment.

This is a new day, about communication, trust, transparency and the importance of science in our regulatory decision-making process. All of us are responsible for ensuring the scientific integrity of our work. All of us are responsible for creating a work environment where everyone feels free to speak up without fear.

To this end, I encourage you to read the Science Integrity Policy. I encourage you to browse the Office of Scientific Integrity intranet page and refresh your knowledge by studying their resources and whiteboards. And please don’t hesitate to contact OCSPP’s Deputy Scientific Integrity Officer, Carol Ann Siciliano, at siciliano.carolann@epa.gov or (202) 564-5489, or EPA’s Scientific Integrity Officer, Francesca Grifo at (202) 564-1687 (office) or (202) 657-8575 (mobile).

I also encourage you to attend the OCSPP Scientific Integrity Training series being launched by Carol Ann. You’ll see more information about that shortly. The first session will feature a presentation and Q&A with Francesca Grifo. The second session will talk about ways to express and resolve Differing Scientific Opinions (DSO). Explore the DSO toolkit here. We also plan a training on Whistleblower protections. Get to know your rights here. More training subjects will follow. Just as important, let’s make Scientific Integrity part of our daily work and our daily conversations. You can count on me. And I know that I can count on you – managers and staff, scientists and non-scientists – to do the same.

All the best,
Michal

Michal Freedhoff, Ph.D.
Acting Assistant Administrator
Office of Chemical Safety and Pollution Prevention
U.S. Environmental Protection Agency