Increased Use of Disinfectants Prompts Spike in Related Calls to Poison Control Centers; President Suggests Injecting or Ingesting Bleach or Using UV Light as COVID-19 Therapeutics; EPA Advice and Major International Disinfectant Producer Roundly Condemn Suggestion

Each blog entry addressing the new coronavirus SARS-CoV-2 brings news of the ever-widening scope of the COVID-19 pandemic. According to the Johns Hopkins Virus Tracker as of this writing on April 24, 2020, worldwide cases number more than 2,766,000 cases and deaths number more than 194,000. Spread across the U.S. continues, with more than 884,000 cases and 50,000 deaths reported. New York continues to have by far the greatest concentration of cases and deaths in the U.S., with 271,000 cases and 21,000 deaths. The New York cases accounts for approximately 30% of U.S. cases and 42% of U.S. deaths. 

As the awareness of the need for disinfects and their use has grown, the misuse of such products and potential poisonings from their use has spiked. The U.S. Centers for Disease Control and Prevention (“CDC”) published an article in the Morbidity and Mortality Weekly Report (MMWR) of April 20, 2020 entitled Cleaning and Disinfectant Chemical Exposures and Temporal Associations with COVID-19.

The article draws on data from Poison Control Center calls. There are fifty-five poison control centers spread across the U.S., each of which provides 24 hour a day professional advice to callers regarding exposures to poisons. The data collected from the call are uploaded to the CDC’s National Poison Data System (NPDS) on a nearly real-time basis.

The article covers the first quarter of 2020. During that period, calls concerning disinfectants increased from 12,801in the same period for 2019 to 17,392 this year, an increase of over 35%. Calls concerning cleaning products increased from 25,021 to 28,158, an increase of slightly more than 7%. The categorization of products actually falls across regulatory jurisdictional lines, as the data groups bleaches with cleaning products and hand sanitizers with disinfectants. The former products, when used as disinfectants, are actually regulated by the U.S. Environmental Protection Agency (EPA) as pesticides, while hand sanitizers are actually over-the-counter drugs regulated by the U.S. Food and Drug Administration (FDA).  

The detailed data provide some interesting insights into the nature of the exposures. In 2020 for disinfectants, over 80% of the exposure routes were ingestion. Even if most of the ingestions were by individuals under 19, that would still leave thousands of adults reporting exposure by ingestion.  This group increased by over 30% and represents the largest portion of the increase in exposures. Ingestion was also the leading route of exposure for cleaning products. The pattern is similar to disinfectants in that even if the majority of exposures of individuals under the age of twenty were by ingestion, it would still leave thousands of adults exposed through ingestion.  

The potential for misuse of these products was potentially aggravated on April 23 when President Trump, referencing the contact times for hard surface disinfectants, suggested that bleach might be either ingested or injected as a therapeutic for COVID-19. In fact, bleach is corrosive; skin or eye contact can cause severe burns. Any ingestion would cause severe mouth, throat and stomach burns. While there may not medical data, any injection would cause burns and potentially fatal systemic poisoning.

Reckitt Benckiser, a major international producer of disinfectants including Lysol®, immediately issued a statement warning against any such use of bleach. See Reckitt Benckiser Statement on Disinfectant Misuse.   To understand the severity of exposure to bleach, here is the warning statement from a typical Lysol® product containing bleach:

WARNING: Causes eye and skin irritation. Do not get in eyes, on skin or on clothing. Vapors may irritate. Use only in well-ventilated areas. Avoid prolonged breathing of vapors. Not recommended for use by persons with heart conditions or chronic respiratory problems such as asthma, emphysema or obstructive lung disease. Harmful if swallowed. For sensitive skin or prolonged use, wear rubber gloves. Wash after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. 

On the same day as the President’s pronouncement, EPA issued guidance on the safe use of disinfectants, including the specific advice to not apply a disinfectant to the human body nor ingest one. See EPA Guidance on Safe Disinfectant Use. In addition, numerous medical experts, including the current and immediate past Commissioners of the FDA, have immediately spoken out against such suggestions. Similar warnings have been issued by  The Clorox CompanyThe American Cleaning Institute, The American Chemistry Counciland the Center for Biocide Chemistries . In fact, under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), such use of a registered pesticide would not be authorized by the product label, and thus would be a violation of Federal law.  Violations of FIFRA are punishable by a penalty of up to $20,288 per offense.

The President also suggested using ultraviolet (UV) light as a therapeutic. UV light is grouped into three categories, denominated as UV-A, UV-B or UV-C, the latter presenting the greatest risk to humans. UV devices designed for sterilization of medical devices and instruments are regulated by the FDFA. UV light exposure, particularly UV-C, poses significant risks.  Overexposure to UV-C light can cause adverse health effects, including acute effects such as erythema (sunburn), photo conjunctivitis and photokeratitis (arc eye). The World Health Organization issued a warning against using UV-C light to disinfect the human body.

In the face of contradictory suggestions EPA continues to combat the sales of products making fraudulent disinfectant claims asserting the ability to control the SARS-CoV-2 virus. On April 23 EPA advised eight internet retail platforms that illegal products were being sold on their platforms. The platforms notified are Facebook, eBay, Alibaba, Shopify, Qoo10, JoyBuy.com, Wish.com and banggood.com.  See EPA Notifies 8 Retail Platforms of Illegal Disinfectant Sales. EPA urges the public to report illegal products at the EPA Violation Reporting Portal  For more information about EPA’s action addressed to SARS-CoV-2 and disinfectants used to control the virus, see EPA Information for Registrants Regarding Disinfectants for the Control of SARS-CoV-2

EPA Takes Further Efforts to Facilitate Greater Availability of Disinfectants Registered for Use Against Novel Coronavirus SARS-CoV-2

The new coronavirus SARS-CoV-2 continues its onslaught across the globe. According to the Johns Hopkins Virus Tracker as of this writing on April 20, 2020, worldwide cases number more than 2,424,000 cases and deaths number more than 167,000. Growth in cases and deaths continues across the U.S., with more than 762,000 cases and 40,700 deaths reported. New York continues to have by far the greatest concentration of cases and deaths in the U.S., accounting for approximately 32% of U.S. cases and 45% of deaths. 

Last week the U.S. Environmental Protection Agency (EPA) announced further temporary regulatory actions to increase the availability of disinfectants labeled for the control of SARS-CoV-2 virus. These products are identified on EPA’s List NThese changes apply only to products on List N.

The new changes revise the notification process, and are reflected in EPA’s Revised Temporary Amendment to Pesticide  Registration Notice 98-10 [April 14, 2020].  Most of the changes are to the scope of changes allowed by the original PR Notice 98-10.  In addition to broadening the scope of changes allowed by notification, EPA has now waived the waiting period normally required before changes by notification can be implemented by the registrant. If the substitution meets the eligibility criteria, the product may be released for sale and distribution once EPA receives the notification. 

To facilitate registrants’ ability to implement these changes, EPA has established a process for submission of such notifications through the Agency’s Central Data Exchange (CDX) portal.  See EPA CDX Portal .

I. Substitute Sources for Commodity Active Ingredients with Similar Purity 

EPA is temporarily allowing registrants of eligible pesticide disinfectant products containing the following active ingredients to substitute any source of the active ingredient, whether registered or not, to produce their registered disinfectant products: 

Ethanol                        64-17-5

Hydrochloric acid       7647-01-0

Sodium Hypochlorite 7681-52-9

Hydrogen Peroxide     7722-84-1

Hypochlorous Acid     7790-92-3

Citric Acid                  77-92-9

L-lactic Acid               79-33-4

Glycolic Acid             79-14-1

The purity of substitute product from the alternate source must fall within the certified limits of the currently registered formulation. Note that this authorization overrides the statement in Chapter 2 of the Registration Manual that an unregistered source will not be considered an “identical/substantially similar” product.” 

II. Substitute Sources of Commodity Active Ingredients with Purities That Are Not Similar 

EPA is also authorizing substituting commodity sources of the identified commodity active ingredients with products with a purity that differs from the original source. The nominal concentration of the active ingredient in the product may not change; in order to achieve the same certified limits, adjustments in inert ingredient concentrations are limited to water only. Self-certification is allowed, and confirmatory efficacy data are not required. 

III. Substitute Sources of Similar Registered Non-Commodity Active Ingredients

As has been the standard process, a registrant may substitute similar registered sources of active ingredients. 

IV. Substitute Sources of Registered Non-Commodity Active Ingredients That Are Not Similar

EPA is also authorizing substituting registered sources of non-commodity active ingredients with alternate sources with a purity that differs from the original source. The nominal concentration of the active ingredient in the product must not change; in order to achieve the same certified limits, adjustment in inert ingredient concentrations are limited to water only. Self-certification is allowed, and confirmatory efficacy data are not required. 

V. Substituting Similar Inert Ingredients

Under existing arrangements, the Confidential Statement of Formula must identify the source of non-commodity inert ingredients, and registrants can substitute a similar inert ingredient source via notification. Composition information from the individual inert supplier must be provided to EPA. For commodity inert ingredients no notification is required, and a substitution may be made at any time. For the identification of commodity inert ingredients see EPA List of Commodity Inert Ingredients 

VI. Adding New Registered Pesticide Producing Establishments

Registrants with formulations that have a registered source of active ingredient may add already-registered producing establishments. This change is in addition to EPA’s already announced policy of expediting the registration of new producing establishments for disinfectants that fall within the designated list.

Other Measures 

EPA also continues to expedite reviews of amendments seeking to add claims for control of SARS-CoV-2, but despite the measures described above, the expedited service is available only for products that already have approved claims for other emerging pathogens. See Guidance on Outbreak of Novel Coronavirus SARS-CoV-2. Registrants who wish to add claims for emerging pathogens for the first time still must go through the standard amendment process.

EPA Releases Significantly Expanded List of Registered Disinfectants Available for Use Against Novel Coronavirus SARS-CoV-2

The spread of the coronavirus SARS-CoV-2 has reached pandemic proportions. According to the Johns Hopkins Virus Tracker, as of this writing on March 17, 2020, there have been over 196,000 cases and over 7,800 deaths worldwide.  Spread across the U.S. is rapidly evolving, with more than 5,700 reported cases and 100 deaths.

In further response to these developments, on March 13, 2020, the U.S. Environmental Protection Agency (“EPA”) issued an updated list of registered disinfectants available for use on hard surfaces for the control of the novel coronavirus SARS-CoV-2, the novel coronavirus that causes COVID-19. See EPA List of Disinfectants for Control of SARS-CoV-2.

The products identified by EPA all established through the Emerging Viral Pathogen Program their efficacy against the COVID-19 coronavirus.  Under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) pesticide products may be used only for the control of pests identified on the product label.  EPA recently announced that the process is available to permit claims for the control of  COVID-19. See Guidance on Outbreak of Novel Coronavirus SARS-CoV-2.

Listed disinfectant registrants must have labels that already identify a specific emerging pathogen as a target organism.  To qualify for being promoted for a newly emerging pathogen, the organism must either be appearing in a human or animal population for the first time or be rapidly increasing in scale or geographic range. EPA requires that the U.S. Centers for Disease Control (“CDC”) must have so identified the organism in question and that the virus presents a survival risk on hard surfaces. CDC has done so for COVID-19. According to EPA, each of these products has demonstrated efficacy against an enveloped virus as least as difficult to control as Coronavirus SARS-CoV-2.

Registrants of the identified products are allowed to communicate to target users the ability to employ their disinfectants for the control of COVID-19. These off-label mechanisms can include technical literature distributed exclusively to health care facilities, physicians, nurses and public health officials, as well as consumer information sources, social media and websites under the control of the registrant. The Guidance prescribes statements that may be used to convey the availability of the product for emerging pathogen control. The availability of the product for control of the emerging virus may not be added to the product label without a formal amendment.

One critical aspect of disinfectant use is often overlooked by users. All products list minimum contact times, meaning the length of time that surface be treated must remain wet. The majority of products require a ten minute contact time, and a significant number require five minutes. There are a limited number of products that have one or two minute periods, and a few as short as thirty seconds. Failure to maintain wetness for the required period means the product will not achieve control, in this case of the virus.  Recent news images of hard surfaces being treated do not instill confidence, as in many cases it is obvious the minimum contact time is not being maintained.  

EPA Releases Updated List of Registered Disinfectants Available for Use Against Novel Coronavirus SARS-CoV-2

The coronavirus SARS-CoV-2 epidemic continues to spread across the globe.  According to the Johns Hopkins Virus Tracker, as of this writing on March 9, 2020, there have been over 111,000 cases and almost 3900 deaths worldwide.  Spread across the U.S. is rapidly evolving, with 566 reported cases and 22 deaths.

In further response to these developments, on March 5, 2020, the U.S. Environmental Protection Agency (“EPA”) issued an updated list of registered disinfectants available for use on hard surfaces for the control of the novel coronavirus SARS-CoV-2, the novel coronavirus that causes COVID-19.  EPA List of Registered Disinfectants Authorized to Claim Control of Novel Coronavirus

The eighty-five products identified by EPA all established through the Emerging Viral Pathogen Program their efficacy against the COVID-19 coronavirus.  Under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) pesticide products may be used only for the control of pests identified on the product label. On August 19, 2016 EPA issued a guidance document entitled Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels.  (“Guidance”). The Guidance outlines a two-stage process for disinfectant registrants to position themselves so that emerging viral pathogens can be identified as target pests without having to pursue a formal label amendment or supply efficacy data on the specific emerging pathogen.  EPA recently announced that the process is available to permit claims for the control of  COVID-19. See  Update and Interim Guidance on Outbreak of 2019 Novel Coronavirus (2019-nCoV).

In order to take advantage of this option, disinfectant registrants must have first pursued a formal amendment adding a specific emerging pathogen to its label. To qualify for being promoted for a new emerging pathogen, the organism must either be appearing in a human or animal population for the first time or be rapidly increasing in scale or geographic range. EPA requires that the U.S. Centers for Disease Control (“CDC”) must have so identified the organism in question, and that the virus presents a survival risk on hard surfaces. CDC has done so for COVID-19. According to EPA, each of these products has demonstrated efficacy against an enveloped virus as least as difficult to control as Coronavirus SARS-CoV-2.

Registrants of the identified products are allowed to communicate to target users the ability to employ their disinfectants for the control of COVID-19. These off-label mechanisms can include technical literature distributed exclusively to health care facilities, physicians, nurses and public health officials, as well as consumer information sources, social media and websites under the control of the registrant. The Guidance prescribes statements that may be used to convey the availability of the product for emerging pathogen control. The availability of the product for control of the emerging virus may not be added to the product label without a formal amendment. 

COVID-19 Poses Potential Threat to 2020 United States Agricultural Chemical Supply

The COVID-19 epidemic which originated in the Chinese city of Wuhan and surrounding Hubei Province poses a threat to the 2020 agricultural chemical supply for the United States. Having been spreading for over a month as of this writing, there are now over 73,000 cases and at least 1,875 deaths reported.

The epidemic poses at least a short term if not longer term threat to agricultural chemical production, which could have a world-wide impact on agriculture. Exports account for two-thirds of Chinese agricultural chemical production, and such exports constitute a significant portion of the supply for the US. In addition to indigenous companies, many major international agricultural chemical companies produce in China. Of some 15,000 pesticide producing establishments registered with the U.S. Environmental Protection Agency, over 1,100, or some 7%, are located in China. That compares with 15% of FDA-registered pharmaceutical production facilities located in China. While only approximately thirty to forty pesticide establishments are in Hubei, the epidemic is presenting a nationwide threat to the industry supply chain. 

The China Crop Protection Industry Association (“CCPIA”) recently released results of a member survey assessing the impact of the epidemic. The short term was uniformly pessimistic, and while holding to the hope that the interruption will not be long term, respondents were united in their belief that annual exports will decrease for 2020. Several major industry international trade shows, including the CAC Exhibition in Shanghai in late February, have already been canceled. 

Production has largely ceased nationwide, with only halting efforts at restarting production. While the Lunar New Year holiday is over, many Chinese citizens who did travel for the holiday are being impeded in their efforts to return home, many cities are confining residents to their homes. Some companies did anticipate this problem and ramped up production prior to the onset of the virus.  However, respondents stated that logistical obstacles are rampant and at present even if there is product on hand, none is able to be exported. Both inbound and outbound trans-ocean shipping has been significantly disrupted. While not directly relevant to agricultural chemicals, a major backlog of refrigerated containers requiring electricity has caused shippers to unload containers at other than the intended ports in order to find available power supplies. Further delays are anticipated as facilities seeking to restart operations must first secure local government approval. As of this writing, the rate of expansion of cases has slowed, but the course of the epidemic remains uncertain.  It is likely that the next weeks will reveal whether a pandemic erupts, which will likely further impair production and exports. 

EPA Responds to Coronavirus; Reminds Registrants of Ability to Add Coronavirus to Disinfectant Product Target Pests on Expedited Basis

In response to the spreading coronavirus epidemic, the U.S. Environmental Protection Agency (“EPA”) issued a reminder to the registrant community that an expedited process is available to add the 2019-nCoV coronavirus as a target pest on appropriate hard surface disinfectant products. 

Under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) pesticide products may be used only for the control of pests identified on the product label. On August 19, 2016 EPA issued a guidance document entitled Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels.  (“Guidance”). The Guidance outlines a two-stage process for disinfectant registrants to position themselves so that emerging viral pathogens can be identified as target pests without having to pursue a formal label amendment or supply efficacy data on the specific emerging pathogen.  EPA has now announced that the process is available to add the 2019-nCoV virus as a target pest.

In order to take advantage of this option, a disinfectant registrant must have first pursued a formal amendment adding a specific emerging pathogen to its label. Once so positioned, the registrant may communicate through off-label channels that the product may be used for a similar, previously unidentified emerging pathogen. Coronaviruses are enveloped viruses, which are among the more easily viruses controlled on hard surfaces. To utilize this mechanism in this instance registrants must have previously added a different enveloped virus to the label. 

To qualify for being promoted for a new emerging pathogen, the organism must either be appearing in a human or animal population for the first time or be rapidly increasing in scale or geographic range. EPA requires that the U.S. Centers for Disease Control (“CDC”) must have so identified the organism in question, and that the virus presents a survival risk on hard surfaces. CDC has done so for 2019-nCoV. See Update and Interim Guidance on Outbreak of 2019 Novel Coronavirus (2019-nCoV)

Once qualified, registrants are allowed to communicate to target users the ability to employ their disinfectants for the control of 2019-nCoV. These off-label mechanisms can include technical literature distributed exclusively to health care facilities, physicians, nurses and public health officials, as well as consumer information sources, social media and websites under the control of the registrant. The Guidance prescribes statements that may be used to convey the availability of the product for emerging pathogen control. The availability of the product for control of the emerging virus may not be added to the product label without a formal amendment. 

EPA Announces Enforcement Settlement for Sale of Unregistered Biocides; Imposes Penalty of $1.498 Million.

The U.S. Environmental Protection Agency (“EPA”) has released a Consent Agreement and Final Order (“Order”) against AFCO C & S LLC of Chambersburg, PA which was signed on September 26, 2019. The Order alleges AFCO engaged in the sale of unregistered biocides, sales of registered biocides in conjunction with unregistered brand names and sales of registered pesticides with claims exceeding those registered. The Order imposes a penalty of $1,489,000, one of higher penalties ever imposed under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”).

The sale of unregistered pesticides occurred 1,031 times from January 1, 2015 through August 9, 2018. During the same period, sales of a registered product misbranded with an unapproved brand name happened forty-one times while sales of registered products for which unregistered claims were made happened five times. To flesh out the scope of claims being made, EPA examined websites, Safety Data Sheets, sales promotional materials and sales contracts and technical data sheets.

EPA commenced this matter by conducting an inspection of AFCO on June 20, 2016.  However, while the sales of the unregistered products must have been obvious early in the investigation, a
Stop Sale Order was not issued until July 13, 2018, over two years after the initial inspection. Since the Order states that unlawful sales continued until August 9, 2018, it would appear that unlawful sales in violation of the Stop Sale Order occurred, although no such violation is identified in the Order.

Given the size of the penalty and an assertion by AFCO that due to the size of the penalty it would be unable to pay the full amount in the standard thirty days without financial hardship, the Order allows payment over twelve monthly payments plus 1% interest. An interesting background note is that on July 25, 2017, midway in the investigation, major pesticide registrant ZEP announced its intent to acquire AFCO. If adequate due diligence was not conducted, ZEP may have received a big surprise as a result of this acquisition.

One important lesson for registrants from this action is the scope of materials that EPA may examine in determining whether pesticidal claims are being made for unregistered products or whether claims beyond the scope of the registered claims are being made for registered products. Particular care needs to be taken that website statements regarding registered products conform to a product’s label.

SCIENTIFIC DEBATE OVER GLYPHOSATE SAFETY CONTINUES AS 3RD JURY FINDS AGAINST MONSANTO

On April 23, 2019, EPA took another step toward upholding the registration of glyphosate by issuing a Proposed Interim Registration Review Document (“PID”) which concludes that the herbicide is not likely to be a human carcinogen. This decision comes as three juries have awarded hundreds of millions of dollars to four individuals suffering from Non-Hodgkin’s lymphoma alleged to have been caused by repeated exposure to glyphosate.

EPA Actions Support Continued Registration

A PID is a step in the Pesticide Registration Review process under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) by which EPA regularly revisits registered ingredients to determine whether they continue to present an acceptable risk to humans and the environment.  It is the latest in a series of actions beginning in 2009 focused on the risks presented by glyphosate. The glyphosate proposed PID represents a major marker in the international debate over whether glyphosate is a potential carcinogen. It was posted in the glyphosate docket on May 6, 2019, and comments are due by July 5, 2019. See https://www.regulations.gov/document?D=EPA-HQ-OPP-2009-0361-2340.

EPA had in December 2016 convened a FIFRA Scientific Advisory Panel meeting to consult on a draft risk assessment of the carcinogenic potential of glyphosate. Based on comments received from the SAP EPA revised its cancer assessment and issued theResponse to the Final Report of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) on the Evaluation of the Human Carcinogenic Potential of Glyphosate. EPA’s final cancer conclusion and its rationale for reaching this conclusion are described in the Revised Glyphosate Issue Paper: Evaluation of Carcinogenic Potential.The EPA’s final cancer assessment includes the newly published analysis of glyphosate use and cancer incidence in the Agricultural Health Study (AHS). The AHS study is a long-term epidemiological study of over 54 thousand pesticide applicators to investigate the association between pesticide exposures and incidence of various types of cancer and non-cancer outcomes. The EPA’s review of the AHS study is described in the Summary Review of Recent Analysis of Glyphosate Use and Cancer Incidence in the Agricultural Health Study. The agency has determined that glyphosate is not likely to be carcinogenic to humans and therefore a quantitative cancer assessment was not conducted.

NGO and Organic Food Producers File Petition to Lower Glyphosate Tolerance for Oats

On September 27, 2018, the Environmental Working Group and a series of organic food producers filed a petition to lower the tolerance for glyphosate in or on oats from 30 ppm to 0.1 ppm and to prohibit preharvest use on oats. The petition was posted on Docket EPA-HQ-OPP-2019-0066 on May 6, and comments are due by June 5, 2019. EPA has stated that it anticipates responding to the petition as part of finalizing the PID.

IARC Classification & Proposition 65

The opponents to glyphosate use were bolstered by a March 2015 determination of the World Health Organization’s International Agency for the Review of Cancer (“IARC”), which found glyphosate to be a probable human carcinogen. See https://www.iarc.fr/featured-news/media-centre-iarc-news-glyphosate/. That decision has been hotly disputed by industry and regulators, including EPA, but continues to be supported by IARC.  Neither the European Union’s Food Safety Authority (2015) nor the U.S. National Toxicology Program (2016) have classified glyphosate as a human carcinogen.

The IARC classification resulted in glyphosate being added as a probable carcinogen under California’s Proposition 65. While the listing continues in place, as a result of industry litigation registrants of glyphosate have been relieved of the obligation to advise persons exposed to it of the cancer risk. See National Association of Wheat Growers v. Zeise(Civ. No. 2:17-2401 WBS EFB) (February 26, 2018)

Private Tort Litigation

As the regulatory actions play out a series of thousands of private actions have been filed in Federal and state courts. Plaintiffs have prevailed in the first three trials to proceed to a verdict.

In Johnson v. Monsanto,the jury in a San Francisco County Superior Court action awarded approximately $289 million in damages, which was reduced by the judge to approximately $78 million.  Bayer, which now owns Monsanto, is appealing the verdict and the plaintiff is appealing the reduction of damages.

In Hardeman v. Monsanto,the first of thousands of cases consolidated in a Multi-District Litigation (“MDL”) in the Northern District of California, the jury awarded $5.2 million in compensatory damages and $75 million in punitive damages. On April 11, 2019, the judge hearing the MDL cancelled the next scheduled bellwether trial, scheduled a hearing May 22 to address how to proceed in the MDL and ordered the parties to engage in mediation.

Most recently on May 13, 2019 the jury inPilliod v. Monsantoin California’s Alameda County Superior Court awarded a married couple $1 million each in compensatory damages and $1 billion in punitive damages. This scale of punitive damages exceeds the permissible ratio of punitive damages to compensatory damages allowed in California, so even if the verdict survives appeal the punitive damage amount will be reduced.

The litigation has proved to be a challenge for Bayer, whose stock has dropped approximately 50% from its 52-week high. In addition, at the April 26 Bayer annual meeting, in a non-binding resolution, a majority of shareholders voted to disapprove Bayer’s actions related to glyphosate.

Conclusion

It remains to be seen whether the two verdicts to date will withstand appeal. Expert testimony is critical to any toxic tort plaintiff’s case, because without expert testimony the necessary causation link can never be established. In Federal court the admissibility of any proposed expert witness testimony must be evaluated according to the five-part standard established by the U.S. Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The Federal judge in the Hardemanbellwether case held that “So long as an opinion is premised on reliable scientific principles, it should not be excluded by the trial judge; instead the weaknesses in an unpersuasive expert opinion can be exposed at trial, through cross-examination or testimony by opposing experts.”

More sense of the directions in which the Federal MDL litigation may go should be learned from the May 22, 2019 conference. Other than directing the parties to select a mediator, nothing further is scheduled at the moment. Several trials are scheduled for the fall of 2019 in St. Louis, Missouri County Court.

While the litigation continues, EPA appears determined to continue the registration of glyphosate. Evidence introduced in one of the trials contained assertions that the administration supports Bayer and the continued registration. Assuming EPA denies the petition related to oats, that mater will no doubt be litigated.

May 14, 2019

Challenges to Chlorpyrifos Grow

In the ongoing saga of the organophosphate insecticide chlorpyrifos, its registration is facing multiple new challenges on a variety of fronts. On the Federal level, attention is focused on the years-long pending Petition to Cancel filed with the U. S. Environmental Protection Agency (“EPA”) by the Natural Resource Defense Council (“NRDC”) and the Pesticide Action Network of North America (“PANNA”). On the state level, the California Department of Pesticide Regulation (“CDPR”) has announced its intention to cancel all registrations of chlorpyrifos, and the state of New York appears headed to enacting a legislative ban on its registration in New York.

Petition to Cancel EPA Registrations

The Petition to Cancel was filed in 2007.  Its history and related litigation is recounted in the prior blog entry EPA Obtains Stay of Execution for Chlorpyrifos from 9thCircuit Court of Appeals. On 2017 EPA had announced that, contrary to staff recommendation to cancel the registrations of chlorpyrifos, it was denying the Petition. See 82 Fed. Reg. 16581 (April 5, 2017).  EPA announced that more data was required to make a decision and therefore a final determination on the safety of chlorpyrifos the review would not be completed until 2022.

Petitioners, joined by five states and the District of Columbia, sought to have the 9thCircuit Court of Appeals compel EPA to grant the Petition and cancel the registration. Initially a three-judge panel of the 9thCircuit ordered EPA to cancel the registrations and tolerances for chlorpyrifos. See League of United Latin American Citizens et al v. Wheeler, 899 F. 3d 814 (9thCir.). EPA then sought rehearing by the full 9thCircuit. Following argument before the full panel, the Court on April 19, 2019 revoked the prior opinion and issued a Writ of Mandamus ordering EPA to respond to the Petition within 90 days, making the deadline approximately July 19.

Given that EPA determined in its Revised Human Health Hazard Assessment and Drinking Water Exposure Assessment for Chlorpyrifos [November 2016] to revoke all food residue tolerances for chlorpyrifos, EPA will face an uphill challenge if it wishes to maintain the chlorpyrifos registrations. It is certain that anything short of a full cancellation will bring this matter back before the 9thCircuit.

California and New York Actions

California and New York have determined that they will not await the outcome of EPA determination on the Petition and through different channels are both moving to terminate chlorpyrifos in their respective states.

In California, CDPR announced on May 8, 2019 that it intends to initiate cancellation proceedings for all chlorpyrifos registrations. It remains to be seen whether registrants or agricultural interests challenge the proposed cancellations.

In New York, which is one of the intervenor states in the LULACmatter, as of April 30, 2019, both houses of the legislature have passed a bill which would in three stages eliminate all uses of chlorpyrifos by December 1, 2021. See S. 5343; A-2477B. Aerial application would be prohibited as of January 1, 2020, following which all uses except applications to apple tree trunks would end as of January 1, 2021. The apple tree use would then end December 1, 2021. While the New York Farm Bureau is on record opposing the legislation, the governor has given no indication of whether he will sign the bill. If he does so, opponents would likely have no recourse. Section 24(a) of the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), 7 USC §136v(a), expressly authorizes states to regulate pesticides more strictly than EPA. That authority leaves opponents with little ground upon which to mount any challenge.

May 10, 2018

Renewed Pesticide Registration Improvement Extension Act Signed Into Law  

On March 8, 2019 the President signed into law S. 438, the Pesticide Registration Improvement Extension Act of 2018. Thus the PRIA fee for service program, which had lapsed as of February 19, 2019, is back in force. Presumably anyone who submitted an application since the lapse can if they wish withdraw and refile the application. If one does so, by paying the PRIA fee they would have a guaranteed decision date for their action. More details are expected as EPA implements the new law.