EPA Reconsidering Paraquat’s Re-Approval

The EPA released an interim decision in 2021 which re-approved the sale and use of paraquat, including aerial application, despite multiple studies linking paraquat exposure with an increased risk of developing Parkinson’s disease.

However, the California Rural Legal Assistance Foundation, Toxic Free North Carolina, the Center for Biological Diversity, Alianza Nacional de Campesinas, Farmworker Justice, the Michael J. Fox Foundation for Parkinson’s Research, and the Farmworker Association of Florida petitioned the United States Court of Appeals for the Ninth Circuit in September 2021, requesting that the court review and set aside the EPA’s interim decision to re-approve paraquat.

The EPA, in response to this petition, filed a motion for voluntary remand with the court, stating that the agency wants to re-examine the risks associated with paraquat before renewing its long-term approval regarding sale and usage.

The EPA asked the court to allow the use of paraquat while its approval is reconsidered by the agency, claiming that opponents of its re-approval didn’t object to it being used while the agency reconsiders its decision.

EPA Wishes To Investigate Petitioners’ Concerns

The petitioners who filed the September 2021 petition filed a brief in May 2022, focusing on concerns relating to human health as well as questions regarding the EPA’s discussion of risk-benefit balancing.

The petitioners specifically challenged the EPA’s assessment of the risk of Parkinson’s disease development associated with paraquat, the agency’s analysis regarding paraquat exposure caused by volatilization of the herbicide, and the agency’s analysis of benefits and costs relating to the usage of paraquat.

In response to the petitioners’ concerns, the EPA has stated that it would like to reconsider its analysis regarding the potential for paraquat to volatilize, causing it to move through the air, as well as its balancing of risks and benefits and its cost assessments. The EPA also stated that they will consider any “remaining substantive issues” that the petitioners raised.

The EPA stated that “there is evidence” that “paraquat may be likely to volatilize,” and that the agency would like to consider the issue of volatilization further.

The EPA’s motion for voluntary remand states that the EPA developed a tool for volatilization screening in order to assess potential risks of bystanders inhaling volatilized pesticides. The motion states that the EPA assessed paraquat with this tool, “concluding that paraquat may be likely to volatilize.”

The motion states that the EPA later found a study concluding that bystanders would not be expected to be suffer inhalation exposure to paraquat after the herbicide was applied to cotton in California. However, the motion states the agency wants to further analyze paraquat’s potential for volatilization.

The motion does not specifically state that the agency wants to reconsider its assessment of the risk of Parkinson’s disease development associated with paraquat, despite numerous scientific studies linking paraquat with Parkinson’s disease, but this issue may be one of the “remaining substantive issues” that the agency reconsiders.

Petitioners Petitioned Court Based On FIFRA Grounds

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) made it so pesticides must generally be registered with the EPA before being distributed or sold in the United States.

7 USC 136a states that pesticides shall be registered by the EPA when the agency decides that:

• Its composition warrants its proposed claims
• Its labeling and any other material required for submission comply with requirements
• It performs the function it is intended to perform without having “unreasonable adverse effects on the environment”
• It generally won’t lead to “unreasonable adverse effects on the environment” when it is used as common and widespread use dictates

7 USC 136 defines “unreasonable adverse effects on the environment,” with its definition including “any unreasonable risk to man or the environment.”

Thus, by challenging the EPA’s interim decision to renew paraquat based on concerns regarding Parkinson’s disease and volatilization, the petitioners challenged the decision based on FIFRA grounds.

EPA’s Interim Decision Stated ‘Insufficient’ Evidence Links Paraquat With Parkinson’s

The EPA’s 2021 interim decision to renew paraquat stated that “there is limited, but insufficient” epidemiologic evidence to come to the conclusion that there exists “a clear associative or causal relationship” between Parkinson’s disease and exposure to paraquat.

However, by stating that they may reconsider “remaining substantive issues,” the EPA may be signaling they wish to reconsider this determination, as numerous scientific studies have linked the herbicide with Parkinson’s disease or causes of Parkinson’s disease:

• A 1999 study determined that dopaminergic neurons are lost due to paraquat exposure. The loss of dopaminergic neurons can lead to the symptoms of Parkinson’s disease.
• A 2004 study determined that two causes of Parkinson’s disease, neuronal cell death and oxidative stress, are induced by paraquat.
• A 2009 study determined that the risk of developing Parkinson’s disease is more than doubled by exposure to paraquat.
• Another study from 2009 determined that the risk of developing Parkinson’s disease is more than doubled by exposure to paraquat.
• A study from 2011 determined that paraquat exposure led to 2.5 times the risk of developing Parkinson’s disease.
• A meta-analysis from 2013 determined that paraquat exposure doubled the risk of Parkinson’s disease development.
• A 2017 study associated paraquat exposure with neurodegenerative effects that can lead to Parkinson’s disease.
• A study from 2017 determined that paraquat exposure raises one’s risk of developing Parkinson’s disease by 1.54 times.
• A study from 2018 determined that paraquat has neurotoxic effects on neurons in the brain which can lead to Parkinson’s disease when they are killed.
• A meta-analysis from 2019 determined that those exposed to paraquat saw 25 percent higher occurrence of Parkinson’s disease.
• A meta-analysis from 2019 determined that paraquat exposure raises one’s risk of developing Parkinson’s disease by 1.64 times.

Thousands Of Lawsuits Allege That Paraquat Caused Plaintiffs’ Parkinson’s Disease

Thousands of lawsuits have been filed against the manufacturers of products containing paraquat, alleging that the herbicide caused the plaintiffs to develop Parkinson’s disease.

These lawsuits seek to recover damages based on numerous causes of action, including:

Strict Liability – Defective Design

When a company is strictly liable for a defective product, it means they are liable for any damages caused by the product, and negligence need not be proven to establish this liability.

Strict liability was established in California by Greenman v. Yuba Power Products, Inc., in which the court stated that a “manufacturer is strictly liable in tort when an article he places on the market, knowing that it is to be used without inspection for defects, proves to have a defect that causes injury to a human being.”

The court stated in Lucas v. City of Visalia that “California recognizes strict liability for three types of product defects — manufacturing defects, design defects, and warning defects (inadequate warnings or failure to warn).”

Products are deemed to have a design defect in California if:

• They don’t perform as safely as an ordinary consumer would expect when used as intended or in a reasonably foreseeable way, or;
• The risk of danger relating to the product’s design outweighs the design’s benefits

Lawsuits argue that products containing paraquat are defective by design, alleging that the herbicide can cause Parkinson’s disease even when the product is manufactured correctly and used correctly or in a reasonably foreseeable manner.

Strict Liability – Failure To Warn

A product is considered defective in California if a company knows or should know that the product is unreasonably dangerous, yet fails to warn about the danger.

Lawsuits argue that products containing paraquat contain a warning defect. The lawsuits allege that paraquat manufacturers knew or should have known that paraquat could cause Parkinson’s disease, as numerous scientific studies have linked the herbicide with the disease. The lawsuits claim that it is paraquat’s redox properties which lead to Parkinson’s disease, and that the scientific community has known about these properties since the 1930s.

Negligence

Negligence is the failure to be reasonably careful in order to stop harm from occurring. It is negligent to do what a reasonably careful person wouldn’t do, and it is negligent to fail to do what a reasonably careful person would do.

California Civil Code §1714 holds negligent parties liable for any harm done by their negligence.

Lawsuits argue that paraquat manufacturers have been negligent by failing to warn that their products could cause Parkinson’s disease, as well as by not testing products containing paraquat adequately.

Breach Of Implied Warranty Of Merchantability

California Civil Code §1792 states that consumer goods sold in the state “shall be accompanied by the manufacturer’s and the retail seller’s implied warranty that the goods are merchantable.”

Lawsuits allege that products containing paraquat breach this implied warranty, as they are not merchantable since they can cause Parkinson’s disease even when manufactured correctly and used correctly or in a reasonably foreseeable way.