By Lisa R. Burchi, James V. Aidala, and Barbara A. Christianson

On November 15, 2022, the California Department of Pesticide Regulation (DPR) made two announcements: an enforcement action relating to 1,3-Dichloropropene (1,3-D) and chloropicrin and an announcement on a proposed rule on additional use restrictions on 1,3-D. These actions may have significant impacts on registrants and growers who use soil fumigants.

Enforcement Action

DPR issued a licensing action against TriCal, a company that performs field fumigations, primarily using chloropicrin and 1,3-D. DPR found that TriCal had numerous violations that resulted in serious illness and injury and dozens of other violations. During a licensing action, DPR can seek civil penalties or seek to revoke or suspend the license of a company that is licensed to do pest control work, sell pesticides, or advise on pest control in California.

DPR states that TriCal has been subject to past enforcement actions dating back to 2014. These past violations include a combined 40 incidents -- four of which were “priority episodes” (i.e., incidents involving serious illness or injury, or an episode involving five or more people). Specifically, TriCal paid over $125,000 in administrative civil penalties to County Agricultural Commissioners and a $44,275 fine to the U.S. Environmental Protection Agency (EPA).

DPR’s press release states that nine episodes were cited in the most recent licensing action, including the following:

• In October 2020, DPR alleged 20 residential bystanders and three members of the Salinas Fire Department experienced symptoms of pesticide exposure from a TriCal misapplication.
• In October 2019, DPR alleged 39 fieldworkers were exposed to 1,3-D and chloropicrin due to TriCal’s misapplication. Thirty-two fieldworkers experienced symptoms of pesticide exposure, and three people sought medical care for their symptoms.
• In October 2018, DPR alleged TriCal misapplied a product containing 1,3-D and chloropicrin and, as a result, 13 residential bystanders experienced symptoms of pesticide exposure.

This licensing action comes as DPR announces proposed regulatory requirements to strengthen use restrictions on 1,3-D to protect public health. In its proposed regulation, DPR 22-005 Health Risk Mitigation and Volatile Organic Compound Emission Reduction for 1,3-Dichloropropene, DPR states its “broad objectives of the proposed regulations are to mitigate the potential 72-hour acute risk and 70-year lifetime cancer risk to non-occupational bystanders from the use of 1,3-D, and to reduce [volatile organic compound] VOC emissions from 1, 3-D field soil fumigations.” This proposal is based in part on a health-protective regulatory target established last year after consultation with state and local agencies. Specifically, the proposed action, if issued in final, would:

1. Allow the use of 1,3-D only for the production of agricultural commodities, effectively prohibiting other uses that are not currently registered;
2. Establish mandatory setbacks (distances from occupied structures where 1,3-D cannot be applied);
3. Set limits on the application rate and acres treated for individual field soil fumigations;
4. Place restrictions on multiple field soil fumigations that do not meet distance or time separation criteria;
5. Limit the allowed methods to apply 1,3-D, including establishing criteria for acceptable types of tarpaulins that can be used;
6. Require an annual report from DPR that includes evaluations of 1,3-D use and air monitoring results; and
7. Require the inclusion of certain information in existing pesticide use records and pesticide use reports.

Comments are due on or before January 18, 2023. DPR will accept written comments that are submitted via U.S. mail and postmarked no later than January 18, 2023. Comments also may be transmitted via e-mail to .(JavaScript must be enabled to view this email address) or by facsimile at 916-324-1491 and must be received no later than 5:00 p.m. (PST) on January 18, 2023.

DPR will conduct a public hearing to accept comments on these amendments. The public hearing is scheduled for January 18, 2023, starting at 9:30 a.m. (PST). The hearing will be in a hybrid format with both a physical location and an option to participate remotely:

Physical Location:

CalEPA Headquarters Building

Byron Sher Auditorium

1001 I Street, 2nd Floor

Sacramento, CA 95814

Remote Location:

Zoom

Webinar ID: 826 1358 3257

Password: 045724

Direct link to join the meeting from a web browser or Zoom client:

https://us02web.zoom.us/j/82613583257?pwd=UGJ0WkxtbFlFYUdrQmJYb3V3QyszUT09

One tap to join from a mobile phone: +16699009128,,82613583257#,,,,*045724#

Or call from a landline: +1-669-900-9128 and enter the Webinar ID and Password (above) when prompted

The hearing also will be accessible via public webcast for persons who would like to watch this hearing without participating. The public webcast can be accessed by visiting the following web address: https://video.calepa.ca.gov/#/

Commentary

These actions add many new restrictions on the use of these pesticides. Growers who rely on these products will have to comply with the new restrictions and hope that they address the state’s concerns or face additional restrictions or even a decision by DPR to not register the pesticides regardless of what EPA’s federal label allows. The state actions may in turn raise new issues for EPA. DPR’s justification for greater controls mentions the possible impact on local communities, which may cause greater focus on environmental justice matters, and the evolution of this issue should be monitored.

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By Lisa R. Burchi and Barbara A. Christianson

On November 3, 2022, the California Department of Pesticide Regulation (DPR) announced it reached a settlement agreement with Amazon.com Services, LLC (Amazon) regarding the illegal sale of pesticides in California. According to DPR, its review of Amazon uncovered multiple violations. Among them, it sold unregistered pesticides in California, failed to report and pay required mill assessment fees associated with the sale of registered pesticides in California, and failed to hold a valid pesticide broker’s license.

Under the terms of the agreement, Amazon will pay DPR a total of $4.97 million -- $3.69 million in unpaid pesticide sales assessment fees and related late penalties, and $1.28 million in civil penalties associated with retail sales of unregistered pesticides into California. DPR states that Amazon also agreed to register as a pesticide broker and report and pay the mill assessment fees associated with all future retail sales of registered pesticides into California.

Under California law, pesticides that are registered by EPA also must be registered by the state before they are used, possessed, or offered for sale in California. Based on DPR’s evaluation of a product’s potential human health and environmental risks and efficacy, DPR may impose state-specific requirements, including additional data requirements or label use restrictions.

California also has its own state requirements for mill assessments, which is a fee to be paid for sales of pesticides that are registered with DPR and sold into California. Specifically, a mill assessment is charged at the first point of sale of a pesticide in California. Generally, the registrant is responsible for reporting sales and paying the mill assessment when it has knowledge, at the time of sales, that the pesticide is being sold in California. If the registrant does not have knowledge at the time of sale, the party that is the first to sell the pesticide in California is responsible for reporting and paying the mill assessment. If a party other than the registrant is the first to sell a pesticide into or within California, this first seller party must obtain either a pesticide broker or a pest control dealer license (whichever is appropriate) from DPR.

Additional information on DPR’s programs is available here.

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By Lisa M. Campbell and Lisa R. Burchi
 
On April 13, 2022, the Office of Environmental Health Hazard Assessment (OEHHA) issued a Notice of Modification to Proposed Regulation on Safe Harbor Warnings for Glyphosate and Addition of Documents to Rulemaking File (Notice). OEHHA first proposed this regulation by publishing a Notice of Proposed Rulemaking on July 23, 2021. OEHHA provided a 75-day comment period on the original proposal and its Initial Statement of Reasons (ISOR), including an extension to file comments until October 7, 2021. It held a public hearing on September 9, 2021.
 
Following its review of comments, OEHHA has determined modifications of the original regulatory text are needed. In addition, OEHHA stated it is relying upon additional documents in this rulemaking and is adding these documents to the rulemaking file. OEHHA originally opened a 15-day public comment period, running from April 13, 2022, through April 28, 2022, however, at the request of several stakeholders, OEHHA extended the comment period to May 5, 2022. Instructions for filing comments are set forth in the Notice. Consistent with the Administrative Procedure Act, OEHHA states it will only address comments received during this comment period that address the modifications to the text of the proposed regulation or documents added to the record. In the Final Statement of Reasons, OEHHA will respond to all comments received during the comment periods on the original July 2021 proposal and on the modified proposal.

Background

OEHHA’s proposal to adopt a new safe harbor warning regulation to address the content of warnings for exposure to glyphosate in consumer products is not without controversy. OEHHA’s initial listing of glyphosate as a substance known to the state to cause cancer was challenged in court. In the 2020 decision for National Association of Wheat Growers et al. v. Becerra et al., the District Court found that the Proposition 65 (Prop 65) safe harbor warning was false and misleading commercial speech under the First Amendment and enjoined enforcement of the warning requirement. More information regarding that decision is discussed in our blog. In addition, in 2019, the U.S. Environmental Protection Agency (EPA) issued a letter stating that it would not approve labeling that includes the Prop 65 warning statement for glyphosate-containing products and that any such warnings would be considered false and misleading and thus misbranding violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Additional information regarding EPA’s determination is discussed in our blog.
 
In proposing Prop 65 warning language for glyphosate, OEHHA states in the ISOR (page 12) that the proposal is intended to take into account the ruling and concerns expressed by the District Court: 
 

OEHHA’s safe harbor regulations are nonmandatory guidance. OEHHA does not have enforcement authority under Proposition 65 and thus cannot require warnings to be given for an exposure to any listed chemical, including glyphosate. The injunction in the National Wheat Growers case is still in effect. Therefore, no enforcement actions can be taken against businesses who do not provide warnings for significant exposures to this chemical. OEHHA does not intend to suggest otherwise by proposing this regulatory action.

OEHHA states further (ISOR page 15):
 

OEHHA has determined that a tailored safe harbor warning for significant glyphosate exposures from consumer products can provide clear and factual and information for the benefit of those who could be exposed. As discussed above, where no consumer product warning is being given under FIFRA for significant exposures to glyphosate, the safe harbor language provides content and methods that businesses can use to provide a warning if they choose to do so. Also, under OEHHA’s implementing regulations, a business that determines it must provide a warning for a worker exposure that is not required under FIFRA may use the proposed consumer product safe harbor content and methods to provide the warning, if appropriate. (Section 25606(a)).

Summary of Proposed Modifications

OEHHA is modifying proposed Section 25607.49, subsection (a)(3) as shown below. Additions and deletions to the proposed text are shown in double-underline (example) and strike-out (example), respectively.
 

(3) The words, “Using this product can expose you to glyphosate. The International Agency for Research on Cancer classified glyphosate as probably carcinogenic to humans. US EPA has determined that glyphosate is not likely to be carcinogenic to humans; other authorities have made similar determinations. Other authorities, including USEPA, have determined that glyphosate is unlikely to cause cancer, or that the evidence is inconclusive. A wide variety of factors affect your potential personal cancer risk, including the level and duration of exposure to the chemical. For more information, including ways to reduce your exposure, go to www.P65Warnings.ca.gov/glyphosate.”

A copy of the full proposed regulatory text (new sections 25607.48 and 25607.49), reflecting the modification, is available here.
 
OEHHA states the proposed modifications are intended to address issues raised in the comments to the initial proposal by: (1) separating the description of the conclusion reached by EPA from the description of the conclusions reached by other authorities; (2) more closely aligning the description of the conclusion reached by EPA with the language EPA used in its conclusion; and (3) changing the modifier of the term “risk” in a manner that accounts for the diverging conclusions EPA and other authorities reached.
 
OEHHA states it also sought input from EPA on whether it could approve the warning language as set forth in this modified proposal, if a pesticide registrant requested approval to include such language on labels of products containing glyphosate sold in California. EPA responded that it could approve the proposed language. Specifically, with regard to its prior 2019 letter and the current warning language, EPA stated:
 
While EPA’s scientific conclusions regarding the glyphosate cancer classification have not changed since the August 7, 2019, letter to glyphosate registrants, it has determined that the new glyphosate-specific safe harbor language proposed in OEHHA’s recent letter is sufficiently clear regarding EPA’s position and thus would not be considered false and misleading. Therefore, this revised language could be approved by EPA if pesticide registrants requested it for inclusion on glyphosate product labels, and the products would not be considered misbranded.
 
OEHHA has added the correspondence with EPA referenced above to the rulemaking file as documents relied on for this rulemaking.

Documents Added to the Record

In the interest of completeness and in accordance with Government Code Section 11347.1, subdivision (a), OEHHA also has added to the rulemaking record the following documents to those it relies in this rulemaking:

• U.S. EPA Office of Pesticide Programs, Label Review Manual, Chapter 7 Precautionary Statements (Revised Mar. 2018), Section IV Determining the precautionary labeling, Part A, Signal word, Section 4 Related information on Proposition 65 warnings, page 7-4.
   
• OEHHA, letter from Lauren Zeise, Director, to Michal Freedhoff, U.S. EPA Assistant Administrator, Office of Chemical Safety and Pollution Prevention (Mar. 21, 2022).
   
• U.S. EPA Office of Chemical Safety and Pollution Prevention, letter from Michal Freedhoff, Assistant Administrator, to Lauren Zeise, OEHHA Director (Apr. 8, 2022).
   
• U.S. EPA Office of Chemical Safety and Pollution Prevention, letter from Michael L. Goodis, Director Registration Division, Office of Pesticide Programs, to registrants of products that contain glyphosate (Aug. 7, 2019).

Copies of these materials are available through the links provided above or here on OEHHA’s website.

Commentary

While the District Court decision enjoins enforcement of any Prop 65 warning requirement for glyphosate, OEHHA stated when it initially proposed the warning language for glyphosate that businesses are not enjoined from providing a warning if they choose to do so. Although OEHHA is proposing slight modifications to the warning language, these modifications do not squarely address the significant concerns raised regarding the initial proposal to the extent that the proposed warning, even as modified, could be considered false and misleading statements under the First Amendment and/or FIFRA. EPA’s April 8, 2022, letter indicates that OEHHA’s modifications to the warning language would be approvable as language that EPA does not consider to be false and misleading should a registrant propose it. If this regulation is approved, it appears that EPA would not reject any label amendments from registrants seeking to add the warning.

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Bergeson & Campbell, P.C.’s (B&C^®) April 20, 2022, webinar “FIFRA Hot Topics” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/7426709986449689102. During this one-hour webinar, Lisa M. Campbell, Partner, B&C, moderated a lively and informative discussion between Edward Messina, Director, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), and James V. Aidala, Senior Government Affairs Consultant, B&C, as they discussed key OPP developments and priorities.
 
With year one of the Biden Administration’s term in the history books, EPA OPP is focusing on long-standing challenges, especially EPA-wide efforts to implement Environmental Justice (EJ) work and determining how best to meet core pesticide registration review obligations in 2022. During this webinar, Messina spoke about the recently released Endangered Species Act (ESA) Workplan, chlorpyrifos and dicamba developments, pesticide product performance data requirements, and per- and polyfluoroalkyl substances (PFAS) issues, as Aidala followed up with questions informed by his many years of experience in senior positions at EPA.
 
We encourage you to view the webinar, subscribe to B&C’s informative FIFRAblog™ and pesticide newsletter, and access more pesticide development news directly from OPP on its website.

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By Lisa R. Burchi and James V. Aidala

On October 6, 2020, the California Developmental and Reproductive Toxicant Identification Committee (DARTIC) announced it will be meeting on December 11, 2020, to discuss the possible developmental and reproductive toxicity (DART) of 22 chemical substances and chemical groups, including glyphosate and its salts, and three neonicotinoid pesticides (acetamiprid, clothianidin, and imidacloprid).  DARTIC is composed of scientists who advise California’s Office of Environmental Health Hazard Assessment (OEHHA) on the prioritization of chemicals for potential Proposition 65 (Prop 65) listing and identification of chemicals that have been shown through scientifically valid testing according to generally accepted principles to cause reproductive toxicity.

Public comments on the 22 substances will be accepted until November 16, 2020, and OEHHA will forward those comments to DARTIC members prior to its meeting. 

The full list of chemicals and chemical groups that DARTIC will discuss are:

• Benzophenone-3;
• Bisphenol S;
• Diazinon;
• Diethylphthalate;
• Domoic acid;
• Glyphosate and its salts;
• Manganese;
• Neonicotinoid pesticides;
  • Acetamiprid;
  • Clothianidin;
  • Imidacloprid;
  • Thiamethoxam;
• Parabens;
  • Butyl paraben;
  • Isobutyl paraben;
  • Methyl paraben;
  • Propyl paraben;
• Per- and polyfluorinated substances (PFAS);
  • Perfluorodecanoic acid (PFDA);
  • Perfluorohexanesulfonic acid (PFHxS);
  • Perfluorononanoic acid (PFNA);
  • Perfluoroundecanoic acid (PFUnDA);
• Titanium dioxide nanoparticles;
• Vinpocetine; and
• Zearalenone.

OEHHA’s document, Prioritization: Chemicals Identified for Consultation with the Developmental and Reproductive Toxicant Identification Committee, presents information on these chemicals or chemical groups for DARTIC’s consideration.  Specifically, OEHHA states:  “For each, an initial, abbreviated appraisal of the scientific information identified through the screening-level literature search and the preliminary toxicological evaluation is presented.”  With regard to glyphosate and its salts, OEHHA provides “a brief overview of the relevant studies published within the last five years and those included in the Toxicological Profile for Glyphosate by ATSDR (ATSDR 2020) that were identified during the preliminary toxicological evaluation.”

No listing decisions will be made by DARTIC at the December meeting.  If OEHHA moves forward to propose to list any substances, it will separately issue a notice and seek public comments.

Discussion

The fact that OEHHA is seeking DARTIC’s review of glyphosate is particularly interesting, as glyphosate is already listed under Prop 65 based on a finding that glyphosate is a chemical known to cause cancer.  That listing is in jeopardy, however, based on a June 2020 court decision that prohibits OEHHA from requiring Prop 65 warnings because the basis for the listing, a determination by the International Agency for Research on Cancer (IARC) that the glyphosate is “probably” carcinogenic to humans, is not consistent with the findings of the U.S. Environmental Protection Agency (EPA) and other agencies.  Additional information regarding glyphosate’s Prop 65 listing is available here.  If OEHHA is not successful in its appeal of the court’s ruling and is successful in listing glyphosate based on its potential to cause developmental and reproductive toxicity effects, the result would be a new basis upon which to impose Prop 65 warning requirements.  At the same time, EPA’s registration review of glyphosate encompasses, in EPA’s view, a health risk assessment, which includes a pesticide’s potential risks of developmental and reproductive effects.  As a result, it is not clear if EPA’s arguments that its FIFRA labeling authority prohibits Prop 65 warnings also would apply to its registration review of health risks, which includes possible developmental and reproductive effects.

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By Lisa M. Campbell, Timothy D. Backstrom, and Lisa R. Burchi

On June 22, 2020, the U.S. District Court for the Eastern District of California granted summary judgment for the Plaintiffs in National Association of Wheat Growers et. al. v. Becerra, and entered a permanent injunction against enforcement of a Proposition 65 (Prop 65) warning label for pesticide products containing glyphosate.  The court found that requiring the registrants of glyphosate products to include such a warning could not be justified as a valid restriction on commercial speech and therefore is contrary to the First Amendment of the Constitution.  The same District Court had previously entered a preliminary injunction against the Prop 65 warning in 2018, and the required warning has consequently never been in effect. (See our February 28, 2018, blog entitled “Eastern District of California Rules on Motion to Enjoin Prop 65 Listing and Warning on Glyphosate Products.”)  The U.S. Environmental Protection Agency (EPA) also has stated that it would not allow a Prop 65 warning to be added to the labeling for any registered glyphosate product because such a warning is misleading and would cause the product to be “misbranded” under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(q)(1)(A). (See our August 15, 2019, blog entitled “EPA Issues Guidance Regarding Prop 65 Labeling Requirements for Glyphosate Products and OEHHA Responds.”)

A Prop 65 warning is required when the California Office of Environmental Health Hazard Assessment (OEHHA) determines that a product contains a substance that has been classified as a human carcinogen by certain authoritative bodies, including the International Agency for Research on Cancer (IARC).  Based on an IARC determination that glyphosate is “probably carcinogenic” in humans, OEHHA listed glyphosate in July 2017 as a chemical known to the State of California to cause cancer, thereby triggering Prop 65 warning requirements.  Despite the IARC determination, every other authoritative body that has considered the matter (including EPA, the European Commission, and the World Health Organization) has reached a contrary determination that glyphosate is not likely to be carcinogenic in humans.  California’s imposition of a Prop 65 warning for glyphosate was challenged in 2018 by the registrant Bayer and a coalition of farming groups and industry stakeholders, who obtained a preliminary injunction against enforcement of the warning.

Before entering the new permanent injunction, the District Court considered whether California’s regulation of commercial speech should be scrutinized under the lower standard set by the Supreme Court in Zauderer v. Office of Disciplinary Counsel or the intermediate standard set by Central Hudson Gas & Electric v. Public Service Commission.  The Zauderer standard only applies to mandatory disclosure of “purely factual and uncontroversial information,” and the Court found that the Prop 65 warning for glyphosate is “misleading” and therefore neither factual nor uncontroversial.  Under the Central Hudson level of scrutiny, a governmental agency may only restrict commercial speech when the restriction directly advances an important governmental interest and where the restriction is not more extensive than necessary to serve that interest.  The Court found that the Prop 65 warning for glyphosate is misleading, and therefore does not directly advance the interest of the state in informing consumers regarding potential cancer hazards, and that the asserted state interest could be effectively advanced by other measures that do not burden freedom of speech in the same manner.

California argued that no Prop 65 warning would actually be required for glyphosate in practice because OEHHA has set a quantitative “safe harbor” level for glyphosate exposure, but the court found that this would not prevent parties other than California from bringing separate enforcement actions to enforce the listing.  Since a Prop 65 warning only needs to be “clear and reasonable,” California also proposed several alternative forms for a warning that would meet state requirements, but the court found these alternate warnings to all be misleading as well.  Based on all of these factors, the court decided to enjoin permanently the enforcement of Prop 65 warning requirements for glyphosate as an unconstitutional burden on commercial speech.

Commentary

Under FIFRA Section 24(b), no state may impose any labeling for a registered pesticide that differs from the labeling approved by EPA.  Although EPA has sometimes been willing to accommodate state labeling requirements or preferences within the labeling approved under FIFRA, there are necessary limits to this practice.  When label language sought by a state becomes misleading, approving it would also be expressly contrary to FIFRA.  How much precedential effect this decision may have with respect to other state requirements for labeling in the future is an issue that registrants should monitor closely. 

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By Lisa M. Campbell, Lisa R. Burchi and Barbara A. Christianson

On April 3, 2020, the California Department of Pesticide Regulation (DPR) announced it would allow enforcement discretion by County Agricultural Commissioners (CAC) for licensing and certification requirements for pesticide applicators who perform sanitization services to control the spread of COVID-19.

DPR states in its announcement that, under normal circumstances, a “Pest Control Business (PCB) must always have a Qualified Applicator License (QAL) holder to supervise pest control services.  Generally, where a PCB performs sanitization services, the QAL must also be certified in Category A, P, or K” described as follows:

• Category A allows PCBs to perform sanitization or disinfection in residential, industrial, or institutional (RII) use settings such as hospitals, schools, or prisons;
• Category P allows PCBs to perform microbial pest control in RII use settings; and
• Category K allows PCBs to perform health related pest control services under a government-sponsored program.

DPR acknowledges that due to Governor Newsom’s March 4, 2020, “Stay at Home” Executive Order, DPR cannot proctor in-person licensing examinations to certify licensees.  DPR thus announced that it will use enforcement discretion by allowing “licensed and registered PCBs to perform sanitization services for the control of COVID-19 if they have a designated individual at each business location with a valid QAL in any category” (emphasis added by DPR).  DPR specifies that enforcement discretion applies when all of the following conditions are met:

1. The professional sanitization service is performed for COVID-19 control and only during the next 90 days.
2. The PCB without the specific QAL license category notifies the CAC in writing with an explanation for why the sanitization work is necessary.
3. Examples of necessary work may include situations in which the PCB is the only licensee registered to do business in the county or where other properly licensed PCBs are unavailable to perform COVID-19-related work.
4. The QAL holder ensures that all applicators applying antimicrobials are properly trained and are in strict compliance with label directions and all other applicable laws and regulations.

The announcement states that those who wish to obtain more information should contact Joe Marade, DPR’s County/State Liaison, at .(JavaScript must be enabled to view this email address).

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By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On February 6, 2020, Corteva Agriscience (Corteva), announced it will discontinue all production of the organophosphate (OP) insecticide chlorpyrifos by the end of the year.  Corteva and its corporate predecessor, Dow AgroSciences, have been the principal global manufacturers of chlorpyrifos.  Corteva announced that its decision to stop selling chlorpyrifos was based entirely on financial considerations.  This announcement came on the same day that Corteva had previously agreed it would end further sales of chlorpyrifos in California, and less than a week after the date the European Union (EU) ended all sales of chlorpyrifos in member states.  These actions followed a number of prior actions taken by other national and state governments to ban or severely restrict chlorpyrifos.  Corteva emphasized in its public statements that the science demonstrates that chlorpyrifos can be safely used, but that the company made a business decision based on the declining markets for the product.  In an interview reported by the Washington Post, Susanne Wasson, Corteva's President for Crop Protection said, “It’s a tough decision for us to make, but we don’t feel like it’s viable going forward.” In other statements, Corteva noted that in the last ten years their share of the global chlorpyrifos market had declined from 75% to less than 20%.

Chlorpyrifos has been registered for use in the U.S. for over 50 years, but has become increasingly controversial in the dozen years since the Pesticide Action Network of North America and the Natural Resources Defense Council filed a petition in 2007 to cancel all registrations and revoke all tolerances for chlorpyrifos.  Following a protracted court battle and a decision by the Ninth Circuit Court of Appeals to force the U.S. Environmental Protection Agency (EPA) to take final administrative action concerning the 2007 petition, EPA proposed near the end of the Obama Administration to revoke all existing tolerances for chlorpyrifos.  A significant basis for this proposal was a controversial decision by a panel of EPA scientists that the default tenfold safety factor established by the Food Quality Protection Act (FQPA) for infants and children, which EPA had previously waived based on studies establishing a threshold for acetylcholinesterase (AChE) inhibition, should be reinstated.

The new EPA safety factor determination was based in large measure on epidemiology studies that reported an association between exposure to chlorpyrifos at levels below the presumed threshold for AChE inhibition and adverse neurodevelopmental effects in children.  Many industry scientists disputed the scientific basis for this EPA determination because confounding exposures and methodological biases in the epidemiology studies may have influenced the reported association with neurodevelopmental effects and because the EPA determination made unprecedented use of epidemiology data.  Beyond the effect on chlorpyrifos, the EPA decision will likely continue to be controversial because EPA included a similar safety factor determination for all OP pesticides, even though the mechanism responsible for the reported neurodevelopmental effects attributed to chlorpyrifos has not been identified and the other OP products were not studied in the epidemiology studies.

In the first year of the Trump Administration, EPA Administrator Scott Pruitt decided not to adopt EPA’s previously proposed tolerance revocation and instead to deny formally the 2007 petition, citing unresolved scientific issues.  This reversal of course, however, was not accompanied by any new scientific assessment or by any explicit revision of the prior FQPA safety factor determination.  Later, the California Department of Pesticide Regulation (DPR) decided to designate chlorpyrifos as a Toxic Air Contaminant, a decision that was noteworthy because it was based primarily on new toxicology studies that DPR stated reported neurodevelopmental effects well below the threshold for AChE inhibition.  DPR deemphasized the epidemiology data relied on in the EPA safety factor determination in its decision.  Although EPA later stated that it would address these new toxicology studies as part of an accelerated registration review process, there were intervening decisions by the EU and by California to ban new sales, which may have contributed to Corteva’s February 6, 2020, decision to cease chlorpyrifos production.

Commentary

The decision by Corteva to cease manufacturing chlorpyrifos reminds us that the decision to continue marketing any chemical substance cannot be based solely on the scientific data, but must also consider the regulatory climate and the economic viability of the product.  For those of us with a long memory, the decision by Corteva is reminiscent of the decision nearly 40 years ago by the Dow Chemical Company to pull the plug on 2,4,5-T and silvex, after Dow had expended millions of dollars and many years of effort to contest an emergency suspension and subsequent cancellation of these herbicides.  Dow made this decision even though it believed that the available data demonstrated the safety of those products.

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By Lisa M. Campbell and Timothy D. Backstrom

On August 14, 2019, the California Department of Pesticide Regulation (DPR) issued cancellation notices to thirteen California registrants of pesticide products containing chlorpyrifos, including Dow Agrosciences LLC (now Corteva).  Each of these notices is referred to as an "Accusation," and each affected registrant has 15 days to request a hearing concerning the proposed cancellation.  DPR's issuance of these notices followed a final decision by the U.S. Environmental Protection Agency (EPA) to deny an administrative petition to revoke the tolerances and cancel the U.S. registrations for chlorpyrifos.  DPR states: "Despite the Trump administration's reversal of a decision to ban the pesticide at the federal level, California continues to move forward to protect public health, workers, and the environment."  Although it is unusual for a State to act unilaterally to cancel a State registration for a pesticide that is still registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), FIFRA Section 24(a) provides that States may separately regulate Federally registered pesticides so long as they do not purport to authorize any sale or use that is otherwise prohibited under FIFRA.

The risk assessment that supports DPR's proposal to cancel chlorpyrifos products is based on five animal studies published in 2016, 2017, and 2018, that report neurotoxicity from chlorpyrifos at exposure levels that are considerably lower than the levels that cause acetylcholinesterase inhibition.  Based on its evaluation these studies, DPR has concluded that developmental neurotoxicity is the critical endpoint for chlorpyrifos and has derived a point of departure for chlorpyrifos risk assessment.  Based on this assessment, DPR previously concluded that chlorpyrifos should be designated as a Toxic Air Contaminant (TAC).  DPR presented its TAC findings to California's Scientific Review Panel at a meeting on July 30, 2018, and the Panel subsequently concluded that the DPR assessment of the developmental neurotoxicity of chlorpyrifos was "based on sound scientific knowledge, and represents a balanced assessment of our current scientific understanding."

On the same day DPR issued its cancellation notices for chlorpyrifos, DPR also announced it has established an Alternatives to Chlorpyrifos Work Group with experts from "agriculture, California universities, environmental justice groups, farmworker health and safety organizations, and pesticide manufacturers…"  DPR has asked this Work Group to develop short-term practical alternatives to chlorpyrifos, along with a five-year action plan.  The Work Group is supposed to conclude its work by the spring of 2020.  The budget for 2019-2020 approved by the California Legislature also includes $5 million in grant funding to develop sustainable alternatives to chlorpyrifos.

Commentary

The DPR decision to cancel chlorpyrifos relies primarily on new animal studies that report that chlorpyrifos causes neurodevelopmental effects at levels that are well below those that inhibit cholinesterase.  DPR refers in passing to the epidemiology studies for chlorpyrifos that EPA used to make its Food Quality Protection Act (FQPA) determination for all organophosphate (OP) pesticides, but these data were not used by DPR to derive its point of departure for chlorpyrifos risk assessment.

EPA scientists have not yet prepared a formal evaluation of the new animal studies for chlorpyrifos, but EPA's decision to deny the petition to revoke tolerances and cancel registrations for chlorpyrifos states that EPA intends to evaluate the new animal studies as part of its registration review deliberations for chlorpyrifos.  The FIFRA registrations for chlorpyrifos may also be affected by pending judicial actions challenging EPA's decision to deny the petition to revoke the tolerances and cancel the registrations for chlorpyrifos.  In this complicated environment, it will be important to monitor the registrants’ and industry’s response to DPR's cancellation actions, as well as their efforts on the pending Federal court litigation and EPA's registration review process for chlorpyrifos.

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By Lisa M. Campbell, Timothy D. Backstrom, Lisa R. Burchi, and James V. Aidala

On August 7, 2019, EPA took long awaited action concerning the inclusion of Prop 65 warning statements for glyphosate on EPA registered pesticide labels, which will likely impact the broader ongoing debate over EPA approval of Prop 65 warnings on pesticide labels.  EPA’s August 7, 2019, letter to glyphosate registrants states that EPA “will no longer approve labeling that includes the Proposition 65 warning statement for glyphosate-containing products.”  EPA stated further that “[t]he warning statement must also be removed from all product labels where the only basis for the warning is glyphosate and from any materials considered labeling under FIFRA for those products.”   Moreover, EPA unequivocally states that “pesticide products bearing the Proposition 65 warning statement due to the presence of glyphosate are misbranded” under FIFRA Section 2(q)(1)(A).  Registrants with glyphosate products currently bearing Prop 65 warning language, where the exclusive basis for such warning is based on the presence of glyphosate, must submit draft amended labeling that removes this language by November 5, 2019.

By way of background, California’s Office of Environmental Health Hazard Assessment (OEHHA) listed glyphosate as a chemical known to the state of California to cause cancer on July 7, 2017.  OEHHA’s listing of glyphosate as a substance under Prop 65 is based on the International Agency on the Research for Cancer (IARC) classifying it as “probably carcinogenic to humans.”  EPA scientists subsequently completed an independent review of the available scientific data on the potential carcinogenicity of glyphosate and do not agree with the IARC classification. Additional information regarding glyphosate is available at B&C’s blog.

Also of note is a February 26, 2018, preliminary injunction issued by the U.S. District Court for the Eastern District Court of California, in response to a motion filed by a coalition including Monsanto, CropLife America, and several growers associations alleging that the IARC classification decision for glyphosate is contrary to the international scientific consensus, that the required Prop 65 warning would be misleading to the ordinary consumer, that compelling the manufacturers of glyphosate to provide such a warning would violate the First Amendment because the warning is not factual and uncontroversial, and that the applicable criteria for injunctive relief were met.  The February 26, injunction precluded OEHHA from enforcing its Prop 65 warning requirements against glyphosate registrants that otherwise would have taken effect on July 7, 2018.  The Court did not rule that glyphosate should be removed from the Prop 65 list as a chemical known to the State of California to cause cancer, but did state that products containing glyphosate would not be required to comply with the warning requirements.  In issuing the preliminary injunction, the Court stated that the required warnings are “false and misleading” and that plaintiffs “have shown that they are likely to succeed on the merits of their First Amendment claim, are likely to suffer irreparable harm absent an injunction, and that the balance of equities and public interest favor an injunction, the court will grant plaintiffs’ request to enjoin [Prop 65]’s warning requirement for glyphosate.”  More information on that case is available at B&C’s blog.  That injunction has not been appealed and remains in place.

Although the glyphosate warning that EPA has refused to allow is based on OEHHA’s recent listing under Prop 65, Prop 65 warnings on pesticide labels generally have been a significant issue since 2016 when OEHHA issued revised regulations regarding the content and transmission of Prop 65 warnings.  As a result of these revisions, many registrants sought to add Prop 65 warning requirements to pesticide labels to meet Prop 65 requirements, but many registrants have not been able to obtain EPA approval for such warnings, resulting in much controversy and discussion.  More information regarding the changes to Prop 65 warning requirements also are available at B&C’s blog.

In its press release announcing its guidance to glyphosate registrants, EPA Administrator Andrew Wheeler states: “It is irresponsible to require labels on products that are inaccurate when EPA knows the product does not pose a cancer risk. We will not allow California’s flawed program to dictate federal policy.”  EPA states that its “independent evaluation of available scientific data included a more extensive and relevant dataset than IARC considered during its evaluation of glyphosate, from which the agency concluded that glyphosate is ‘not likely to be carcinogenic to humans.’”  Wheeler is further quoted as stating: “It is critical that federal regulatory agencies like EPA relay to consumers accurate, scientific based information about risks that pesticides may pose to them. EPA’s notification to glyphosate registrants is an important step to ensuring the information shared with the public on a federal pesticide label is correct and not misleading.”

OEHHA immediately released its own press release on August 13, 2019, in which it “objects to US EPA’s characterization of any warning concerning glyphosate’s carcinogenicity as a false claim.’”  After reiterating OEHHA’s listing glyphosate based on the IARC determination, OEHHA states that EPA’s position “conflicts with the determination made by IARC” and that “it is disrespectful of the scientific process for US EPA to categorically dismiss any warnings based on IARC’s determinations as false.”

Commentary

The Court’s February 26, 2018, preliminary injunction was considered a significant development both for glyphosate specifically and perhaps for Prop 65 warning requirements generally, especially considering the recent influx to EPA of label amendments seeking EPA approval of revised Prop 65 warning language to address OEHHA’s revised regulatory changes.  EPA’s guidance is equally significant, as EPA has now rejected the inclusion of a Prop 65 warning that EPA believes is misleading on a federal pesticide product label.

FIFRA Section 24(b) expressly prohibits any State from requiring any label language for a registered pesticide product beyond the labeling approved by EPA, and EPA has now declined to approve pesticide labeling that includes the Prop 65 warning for glyphosate. In some instances, EPA has been willing as a courtesy to approve labeling changes requested by a State, but the glyphosate determination demonstrates that EPA will not accept any label revisions that conflict materially with its own determinations.  Although glyphosate is a fairly complex and controversial case, it will be important for registrants to monitor the evolution of EPA’s standard for when it will or will not approve a Prop 65 warning on a federal label, since this issue has been the subject of considerable controversy over the past several years.

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