[X] CLOSEMAIN MENU

  • Archives

  • Categories

    • air pollution (8)
    • Announcements (601)
    • Antibiotic Resistance (40)
    • Antimicrobial (17)
    • Aquaculture (30)
    • Aquatic Organisms (35)
    • Bats (7)
    • Beneficials (51)
    • Biofuels (6)
    • Biological Control (34)
    • Biomonitoring (40)
    • Birds (26)
    • btomsfiolone (1)
    • Bug Bombs (2)
    • Canada (10)
    • Cannabis (29)
    • Centers for Disease Control and Prevention (CDC) (9)
    • Chemical Mixtures (5)
    • Children (112)
    • Children/Schools (240)
    • cicadas (1)
    • Climate (30)
    • Climate Change (85)
    • Clover (1)
    • compost (5)
    • Congress (17)
    • contamination (154)
    • deethylatrazine (1)
    • Disinfectants & Sanitizers (18)
    • Drift (14)
    • Drinking Water (15)
    • Ecosystem Services (12)
    • Emergency Exemption (3)
    • Environmental Justice (166)
    • Environmental Protection Agency (EPA) (515)
    • Events (88)
    • Farm Bill (20)
    • Farmworkers (195)
    • Forestry (5)
    • Fracking (4)
    • Fungal Resistance (6)
    • Fungicides (25)
    • Goats (2)
    • Golf (15)
    • Greenhouse (1)
    • Groundwater (14)
    • Health care (32)
    • Herbicides (38)
    • Holidays (37)
    • Household Use (9)
    • Indigenous People (6)
    • Indoor Air Quality (6)
    • Infectious Disease (4)
    • Integrated and Organic Pest Management (71)
    • Invasive Species (35)
    • Label Claims (49)
    • Lawns/Landscapes (248)
    • Litigation (341)
    • Livestock (9)
    • men’s health (1)
    • metabolic syndrome (3)
    • Metabolites (4)
    • Microbiata (22)
    • Microbiome (28)
    • molluscicide (1)
    • Nanosilver (2)
    • Nanotechnology (54)
    • National Politics (388)
    • Native Americans (3)
    • Occupational Health (15)
    • Oceans (10)
    • Office of Inspector General (3)
    • perennial crops (1)
    • Pesticide Drift (162)
    • Pesticide Efficacy (10)
    • Pesticide Mixtures (9)
    • Pesticide Regulation (775)
    • Pesticide Residues (183)
    • Pets (36)
    • Plant Incorporated Protectants (1)
    • Plastic (7)
    • Poisoning (20)
    • Preemption (43)
    • President-elect Transition (2)
    • Repellent (4)
    • Resistance (117)
    • Rights-of-Way (1)
    • Rodenticide (33)
    • Seasonal (3)
    • Seeds (6)
    • soil health (16)
    • Superfund (4)
    • synergistic effects (19)
    • Synthetic Pyrethroids (16)
    • Synthetic Turf (3)
    • Take Action (587)
    • Textile/Apparel/Fashion Industry (1)
    • Toxic Waste (11)
    • Volatile Organic Compounds (1)
    • Women’s Health (25)
    • Wood Preservatives (36)
    • World Health Organization (10)
    • Year in Review (2)
  • Most Viewed Posts

Daily News Blog

08
May

EPA Proposes to Stop Most Uses of Highly Toxic Insecticide in Food and Water, But Open to Negotiating

U.S. Environmental Protection Agency (EPA) proposes ending agricultural use of acephate, an organophosphate pesticide, a well-known neurotoxicant.

(Beyond Pesticides, May 8, 2024) In an unexpected turnaround, the U.S. Environmental Protection Agency (EPA) announced at the end of April a Proposed Interim Decision (PID) to discontinue all but one application of the insecticide acephate. Acephate is an organophosphate pesticide, a well-known neurotoxicant, widely banned globally, including in the European Union. Under the proposal, all uses would end except for the injection of trees that do not produce fruit or nuts. In its proposed action, EPA asks the manufacturer to offer the agency a voluntary settlement, a process that typically compromises the health of the public, workers, and the environment.

Acephate, an organophosphate (OP) pesticide, is approved for use in both agricultural settings, including crops like cotton and soybeans, and nonagricultural applications, such as injections for forestry trees. Acephate affects the nervous system by inhibiting the acetylcholinesterase (AChE) enzyme. Importantly, chronic, low levels of exposure can cause a range of adverse human health outcomes, from cancer to birth defects, reproductive and developmental problems, and learning disabilities.

While the proposed April interim decision, if it comes to pass, is welcomed by advocates, some are concerned that EPA’s proposal does not fully critique the scientific documents and conclusions on risk that it had previously published in August 2023. The earlier proposal was highly controversial because the assessment, and a proposed downgrading of risk and loosening of standards, relied on still controversial testing methods that did not consider laboratory animal testing.

On August 30, 2023, the agency published the following, relying on a revised acephate human health draft risk assessment (HH DRA) which would have allowed ten times more acephate on food than the currently allowed limits:

“Taking the WOE [weight of evidence] evaluation for DNT [developmental neurotoxicity] potential into account, although acephate and methamidophos are known neurotoxicants (i.e., chemicals that disrupt normal activity of the nervous system), there is little to no evidence that acephate or methamidophos are developmental neurotoxicants (i.e., chemicals that impact the normal development of the nervous system during pregnancy or childhood). Therefore, there is no additional risk when exposures of acephate or methamidophos occur to pregnant women or children. Changes in acetylcholinesterase (which causes a neurotoxic effect, not a developmental neurotoxic effect) continues to be the most sensitive and health-protective endpoint for the acephate human health risk assessment. As a result, EPA concluded there is reliable chemical-specific data to support reducing the acephate FQPA [Food Quality Protection Act] factor to 1x [no additional margin of safety for children provided for under FQPA].”

EPA explains the FQPA safety factor as follows: “[T]he Food Quality Protection Act safety factor (FQPA SF) . . . is intended to provide an additional 10X margin of safety to account for any additional risk to pregnant women and children, but which can be reduced or removed if a scientific determination is made that no such additional risk exists.

Then on April 30, 2024, EPA reversed itself with the following announcement:

“Today, the U.S. Environmental Protection Agency (EPA) released a revised human health draft risk assessment (HH DRA) and refined drinking water assessment (DWA) for acephate, an organophosphate pesticide (OP) that is registered for both agricultural and non-agricultural uses. The acephate HH DRA includes an assessment of methamidophos, which is also an OP compound that is formed when acephate is metabolized. The revised HH DRA showed significant dietary risks of concern from drinking water for registered uses of acephate, including non-agricultural uses. EPA also identified dietary risks of concern when only the two highest agricultural usage sites (measured by pounds sold), cotton and soybean, are considered.”

Where the agency will end up with these competing analyses remains to be seen; however, it is clear that the methodologies used to reach these decisions raise important scientific questions about the choices affecting the health of children and the general public who are eating acephate residues in their food and water.

Before making a decision, EPA will take comments under a 60-day comment period and presumably sort out the science and exposure patterns. According to the agency, “Acephate is proceeding through EPA’s standard registration review process. The revised HH DRA and DWA released in August 2023 and the PID released today are open for public comment for 60 days. Commenters may propose alternative mitigation for the Agency’s consideration for some or all uses of acephate, and the Agency will respond to these comments in the Interim Decision.”

Compromising the Public’s Health with Industry Negotiations?

Here is where the negotiations with the chemical manufacturer begin. Regulation by negotiation is EPA preferred approach to protecting the public. In its release, the agency explains its modus operandi: “If EPA determines that alternative mitigation options that are voluntarily agreed to by the registrant can address the identified risks to satisfy the standard for continued registration of the pesticide, this could allow EPA to put protections in place faster than the statutorily required process for involuntary cancellation that can take up to five years. Acephate is one of 18 OPs currently in registration review, with many scheduled to have interim decisions between 2024-2026.”

“While we believe that the accepted science supports acephate’s immediate removal from the market to protect developing fetuses and children, if past is prologue, EPA will allow itself to be whipsawed by the negotiation process, rather than enforce the intent and letter of the law,” said Jay Feldman, executive director of Beyond Pesticides. He continued, “We certainly urge that the agency follow the law—not negotiate away the public’s health and not capitulate to industry threats of litigation.”

Advocates and scientists have raised concerns about the underlying scientific approach used by the agency in its August announcement, which remains undisputed in its proposed interim decision last week. EPA’s history of negotiating away public health runs deep. With acephate, it appears that EPA will continue its pattern of negotiating with pesticide manufacturers and industry to elicit voluntary use restrictions, rather than cancel, suspend, or decline to reregister a pesticide without manufacturer concurrence.

While there are many examples of negotiated EPA decisions, the highly neurotoxic, carbamate insecticide aldicarb stands out as an example of this highly criticized EPA process. Behind closed doors in 2010, EPA and the chemical’s manufacturer, Bayer CropScience, announced an agreement on a set of measures to gradually reduce and ultimately ban fully the use of the insecticide in the U.S. This decision arrived on the heels of a revised risk assessment in which EPA found that babies and children under the age of five can ingest levels of the insecticide through food and drinking water at levels that exceed limits that the agency finds safe. As readers will recall, the intermediate ingredient in aldicarb, methyl isocyanate (MIC), caused an explosion in Bhopal, India, killing up to 20,000 people. Then, in December 2023, it was reported that EPA is again considering allowing the use of aldicarb in Florida citrus, nearly 14 years after the agency and the chemical’s manufacturer announced that it was being banned (technically voluntarily canceled). Please see more on this and Beyond Pesticides’ related Action here.

Acephate Use

Progressive Farmer reported on April 30, 2024, “In an assessment…by the EPA Biological & Economic Analysis Division… the insecticide [acephate] is used on soybeans almost exclusively in the Midsouth states of Arkansas, Louisiana, Mississippi and Texas. It is a minor component of insect pest management programs nationally, being applied to less than 2% of acres, but acephate is applied to 19% of soybeans within the Midsouth [states of Arkansas, Louisiana, Mississippi, and Texas].” 

A Brookings article by Nathan Donley, PhD and Environmental Health Science Director for the Center for Biological Diversity in September 2022 notes that over 4,370,000 pounds of acephate are used annually in the U.S., while banned or being phased out in the European Union, Brazil, and India. Dr. Donley notes that the U.S. is unable to implement rational regulation of pesticides, as other parts of the world continue to eliminate agricultural use of many of the most toxic pesticides. For example, in 2019 the U.S. used 322 million pounds of 70 agricultural pesticides that are banned in the European Union. Similarly, the U.S. uses 40 million pounds of pesticides banned or phased out in Brazil.

New Methodology Tests (NAMs)

EPA’s review of acephate (and the insecticide malathion) is notable as it marks two initial instances where the agency has proposed adjusting its legal safety limits primarily based on non-animal tests to assess the chemical’s effects on brain development through reevaluation of the Food Quality Protection Act safety factor. However, in announcing the PID last month, EPA identified risks to workers, homeowners, and ecosystems from currently approved uses of acephate in drinking water as justification for ending acephate use, except as a tree injection.

Regarding the August 30 risk calculations conducted by EPA, the agency developed new tests, known as “new approach methodologies” or NAMs, with the Organization for Economic Cooperation and Development, which presented its initial recommendations in 2023. Those findings stressed the need for additional information and follow-up studies as the nervous system is “arguably the most complicated organ in the body” and “involves integration of intracellular, intercellular, interregional, and system interactions.”  (page 45).

The 2016 amendments to the Toxic Substances Control Act (TSCA) mandate EPA to promote the adoption of scientifically valid testing methods and strategies that minimize or eliminate the need for testing on vertebrate animals. Developing “new approach methodologies” (NAMs) is intended to aid in establishing exposure limits, health advisories, and cleanup policies for harmful chemicals found in various environments and consumer products. However, the effectiveness of these cell-based methods hinges on their ability to provide scientific data of equivalent or superior quality and relevance compared to traditional animal testing methods. Despite their potential, the majority of NAMs have not undergone thorough validation for assessing critical health effects, apart from a few acute toxicity measurements. Consequently, advocates argue these ‘new approach methodologies’ have yet to fulfill the TSCA criteria for replacing or reducing reliance on animal studies in regulatory decision-making.

EPA’s own scientific advisory panels have found this methodology inadequate, specifically for properly assessing the cumulative impacts of pesticides on human health and development. The Children’s Health Protection Advisory Committee, a body of external researchers and community leaders who advise EPA, recommended that EPA limit the use of data from this methodology and use it only in conjunction with other data. In addition, California’s Department of Pesticide Regulation said the tests were inadequate to support “health-protective decisions” and urged EPA to continue developing this methodology before using it to replace traditional animal studies. Lastly, OECD warned against using the tests to conclude a chemical does not interfere with the brain’s development.

Acephate and malathion are two of the 18 organophosphates currently under review by EPA, with expected interim decisions in 2024-2026. Scientific agreement has long held that children are especially vulnerable to the dangers posed by pesticides, leading the EPA to implement stricter regulations. However, the agency is currently suggesting the elimination of these additional protections for acephate and malathion, based on results from ‘new approach methodologies’ (NAM) tests.

Acephate is in the same chemical class as the well-known neurotoxic chlorpyrifos. These insecticides inhibit proper nerve functioning, leading to paralysis and death in exposed insects; a large enough dose will cause similarly acute effects in humans. Importantly, chronic, low levels of exposure can cause a range of adverse human health outcomes, from cancer to birth defects, and reproductive and developmental problems. Researchers often look at exposures in the womb or at a young age because these are considered ‘critical windows of vulnerability’ during which even small amounts of a pesticide can create long-term damage.

Chemicals like acephate, with the capacity to disrupt the endocrine (hormonal) system by mimicking hormones in the body, are particularly pernicious. In the case of endocrine disruptors, science shows that lower amounts can result in worse health impacts than exposure to higher amounts, a phenomenon known as ‘non-monotonic dose response.’ The scientific literature on these chemicals has upended traditional toxicology, which goes by the oft-repeated phrase, ‘the dose makes the poison.’ Endocrine disruptors reveal this mode of thinking to be outdated, and dangerous to ignore.

EPA Flawed Approach to Cumulative Impact Risk Assessment

The use of such tests is in direct opposition to several executive orders by President Biden requiring EPA to develop policies and actions to assess the cumulative impacts of chemical exposures. Last year, the EPA’s Office of the Inspector General (OIG) released a report concluding that EPA “took a siloed approach” to the cumulative impacts of chemical exposures and the disproportionate nature of those exposures. This approach keeps different parts of the EPA from coordinating their efforts and hinders understanding of the breadth and depth of chemical exposures.

Pesticides are almost always mixtures of “active” and “inert” ingredients. As Beyond Pesticides reported previously, a 2021 study by Robert Sprinkle, MD, PhD, and Devon Payne-Sturges, DrPH, in Environmental Health, took a comprehensive look at EPA’s practices regarding mixtures. The authors write that in the original 1976 Toxic Substances Control Act, mixtures were excluded from the agency’s definition of a “chemical substance.” What this means in practice is that “[a]n environmental mixture could not be, in TSCA terms, a ‘mixture’ if its components include chemical substances altered in the environment. Nor could the still toxic breakdown products of two different industrial substances constitute a mixture.” There is an exception: if EPA finds that if a mixture’s effects could not be predicted by each constituent’s effects, laboratory testing would be required. This means that the agency could view each component of a mixture as “acting in isolation both from nature and from each other.”

What Will EPA Do to restrict acephate?

As Beyond Pesticides and Public Employees for Environmental Responsibility (PEER) wrote in a 2021 critique, EPA is an agency so captured by industry that it has lost sight of its health and environmental mission. EPA’s Office of Pesticide Programs (OPP) has registered more than 18,000 separate pesticide products—far more than any other country—and approximately 2 billion pounds (including wood preservatives) of pesticides are sold annually in the U.S. They are used annually over roughly 250 million acres of farmland, across millions of acres of urban and suburban lands, and inside millions of homes, schools, and other buildings. Yet, the letter recounts a litany of improper pesticide approval decisions. The cumulative effects of decades of this regulatory abuse are untold human deaths, disabilities, and illnesses. Mr. Feldman said, “We call on the Biden Administration to be a hero for health—the fastest thing it can do is immediately revoke the worst pesticides,” pointing to the 25 specific steps the coalition identifies that OPP can take to avoid or mitigate its mistakes in moving forward, all within its current authority. “Horror stories have piled up for too long and Americans no longer are safe from the very agency charged with protecting them.”

Beyond Pesticides urges a systemic move toward the adoption of proven agricultural methods and systems that do not use acephate, malathion, and other toxic synthetic pesticides: organic and certified organic regenerative agriculture.  Beyond Pesticides and other advocates call for a strategy that eliminates agricultural chemicals and supports organic agriculture. These measures also address other crises, including microbial support for ecosystem health and biodiversity. Industrial farming systems dependent on synthetic fertilizers and other chemical inputs can be replaced with organic systems that do not use toxic chemicals, in which animals and feed sources are fully integrated, and farmworkers’ health is protected.

To stay informed and raise your voice on this and other pesticide regulatory decisions, click here for updates from Beyond Pesticides.

All unattributed positions and opinions in this piece are those of Beyond Pesticides.

Sources:

EPA Proposes to Cancel All but One Use of Pesticide Acephate to Protect Human Health, EPA announcement, April 30, 2024
EPA Proposes Ban on Controversial Pesticide Acephate, ProPublica, May 1, 2024
EPA Proposes Relaxed Limits on Acephate, a Toxic Pesticide, ProPublica, April 24, 2024
EPA Publishes Updated Risk Assessments for Chemical Acephate, EPA announcement, August 30, 2023
Acephate: Second Revised Draft Human Health Risk Assessment (DRA) in Support of Registration Review, EPA website, August 29, 2023
Approach for Evaluating Developmental Neurotoxicity Potential for the Organophosphate Pesticides, EPA website, August 29, 2023
Evaluation of the Developmental Neurotoxicity Potential of Acephate/Methamidophos to Inform the FQPA Safety Factor, EPA website, August 29, 2023

Initial Recommendations on Evaluation of Data from the Developmental Neurotoxicity (DNT) In-Vitro Testing Battery, OECD Environment, Health and Safety Publications Series on Testing & Assessment No. 377, Organisation for Economic Co-operation and Development, November 3, 2023

 

Share

2 Responses to “EPA Proposes to Stop Most Uses of Highly Toxic Insecticide in Food and Water, But Open to Negotiating”

  1. 1
    Cathie Wanner Ernst Says:

    Protect consumers Not Big Business!?

  2. 2
    Pam Wilbourn Says:

    PLEASE DO NOT ALLOW ANY POISONS IN OUR FOOD,YOU DO REALIZE YOU EAT THIS FOOD ALSO,,,RIGHT?

Leave a Reply

  • Archives

  • Categories

    • air pollution (8)
    • Announcements (601)
    • Antibiotic Resistance (40)
    • Antimicrobial (17)
    • Aquaculture (30)
    • Aquatic Organisms (35)
    • Bats (7)
    • Beneficials (51)
    • Biofuels (6)
    • Biological Control (34)
    • Biomonitoring (40)
    • Birds (26)
    • btomsfiolone (1)
    • Bug Bombs (2)
    • Canada (10)
    • Cannabis (29)
    • Centers for Disease Control and Prevention (CDC) (9)
    • Chemical Mixtures (5)
    • Children (112)
    • Children/Schools (240)
    • cicadas (1)
    • Climate (30)
    • Climate Change (85)
    • Clover (1)
    • compost (5)
    • Congress (17)
    • contamination (154)
    • deethylatrazine (1)
    • Disinfectants & Sanitizers (18)
    • Drift (14)
    • Drinking Water (15)
    • Ecosystem Services (12)
    • Emergency Exemption (3)
    • Environmental Justice (166)
    • Environmental Protection Agency (EPA) (515)
    • Events (88)
    • Farm Bill (20)
    • Farmworkers (195)
    • Forestry (5)
    • Fracking (4)
    • Fungal Resistance (6)
    • Fungicides (25)
    • Goats (2)
    • Golf (15)
    • Greenhouse (1)
    • Groundwater (14)
    • Health care (32)
    • Herbicides (38)
    • Holidays (37)
    • Household Use (9)
    • Indigenous People (6)
    • Indoor Air Quality (6)
    • Infectious Disease (4)
    • Integrated and Organic Pest Management (71)
    • Invasive Species (35)
    • Label Claims (49)
    • Lawns/Landscapes (248)
    • Litigation (341)
    • Livestock (9)
    • men’s health (1)
    • metabolic syndrome (3)
    • Metabolites (4)
    • Microbiata (22)
    • Microbiome (28)
    • molluscicide (1)
    • Nanosilver (2)
    • Nanotechnology (54)
    • National Politics (388)
    • Native Americans (3)
    • Occupational Health (15)
    • Oceans (10)
    • Office of Inspector General (3)
    • perennial crops (1)
    • Pesticide Drift (162)
    • Pesticide Efficacy (10)
    • Pesticide Mixtures (9)
    • Pesticide Regulation (775)
    • Pesticide Residues (183)
    • Pets (36)
    • Plant Incorporated Protectants (1)
    • Plastic (7)
    • Poisoning (20)
    • Preemption (43)
    • President-elect Transition (2)
    • Repellent (4)
    • Resistance (117)
    • Rights-of-Way (1)
    • Rodenticide (33)
    • Seasonal (3)
    • Seeds (6)
    • soil health (16)
    • Superfund (4)
    • synergistic effects (19)
    • Synthetic Pyrethroids (16)
    • Synthetic Turf (3)
    • Take Action (587)
    • Textile/Apparel/Fashion Industry (1)
    • Toxic Waste (11)
    • Volatile Organic Compounds (1)
    • Women’s Health (25)
    • Wood Preservatives (36)
    • World Health Organization (10)
    • Year in Review (2)
  • Most Viewed Posts