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 Company, The 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 Continues 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 N. These 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 .

  1. 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.”

  1. 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.

2. 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.

3. 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.

4. 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

5. 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 Announces Enforcement Efforts Addressing Fraudulent SARS-CoV-2 Disinfectant Claims

Each blog entry addressing the new coronavirus SARS-CoV-2 reflects the continuing onslaught of the pandemic. According to the Johns Hopkins Virus Tracker as of this writing on April 11, 2020, worldwide cases number more than 1,760,000 cases and deaths number more than 107,000. Spread across the U.S. continues, with more than 519,000 cases and 20,000 deaths reported. New York continues to have by far the greatest concentration of cases and deaths in the U.S., accounting for a significant portion of each.

The U.S. Environmental Protection Agency (EPA”) has recently announced actions to prevent the sales of products making fraudulent disinfectant claims asserting the ability to control the SARS-CoV-2 virus. In the U.S., disinfectants are regulated as pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”). Each individual product must be registered with EPA as well as every state in which it is offered for sale. A violation of FIFRA, such as selling an unregistered disinfectant, carries a penalty of up to $20,288 for each offense.

EPA actions include educational efforts with major retailers and retail trade associations, as well as enforcement actions directed at specific products for which fraudulent claims are being made. EPA is coordinating with major online retailers to assist them in identifying unlawful products. Amazon has stated that it has removed from its listings more than 6 million products making illegal claims and has created algorithms to screen listings for such products.

While urging the public to report illegal products, EPA does not reveal any information regarding pending investigations or enforcement actions. Only when a matter is resolved does information become public. Nonetheless EPA has identified four products and their associated claims as examples of unlawful claims and presumably the subject of enforcement actions. They are:

  • Lanyards that claim to protect wearers from coronavirus
  • Unregistered disinfectant tablets
    • Epidemic prevention Chlorinating Tablets Disinfectant Chlorine Tablets Swimming Pool Instant Disinfection Tablets Chlorine Dioxide Effervescent Tablet Chlorine Disinfectant 100g Cozy apposite Fun Suit
    • The Flu Virus Buster, CLO2 Disinfection Sticker, Removable sterilize air purifier, Anti COVID-19, Stop Coronavirus disease infection /Influenza Buster Disinfectant 1 Box / 10 Tablets
  • Unregistered disinfectant sprays
    • Fullerene silver antibacterial solution/24 Hour Defense Hand Sanitizer Disinfectant Spray Against Corona Virus COVID- 19 Kills 99.99% Of Germs Bacteria 24 Hours of Lasting Protection Alcohol Free 50ml (1.7 fl. oz)
  • Unregistered disinfectant wipes
    • 99.9% Sterilization Wipes/16/32/48/64/96pcs Sterilization Rate of 99% Disinfection Wet Wipes and Paper Napkin Prevention of Coronavirus

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 Broadens Efforts to Increase Availability of Disinfectants Registered for Use Against Novel Coronavirus SARS-CoV-2

Each blog entry addressing the new coronavirus SARS-CoV-2 reflects the continuing onslaught across the globe. According to theJohns Hopkins Virus Tracker as of this writing on April 5, 2020, worldwide cases number more than 1,260,000 cases and deaths number more than 68,000. Rapid spread across the U.S. continues, with more than 331,000 cases and 9,400 deaths reported. New York continues to have by far the greatest concentration of cases and deaths in the U.S., accounting for a significant portion of each.

In response to enormous public demand and supply chain problems being encountered by disinfectant registrants, the U. S. Environmental Protection Agency (EPA) has now taken the following additional steps:

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 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 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.

EPA Denies Chlorpyrifos Cancellation Petition; Six States File Challenge in 9thCircuit  

Despite its registration having been upheld by the U.S. Environmental Protection Agency (“EPA”), the insecticide chlorpyrifos continues to face multiple challenges to its continued use. The continued EPA registration is again being challenged in Court by a collection of states, while California is moving ahead to administratively cancel all registration and New York awaits the Governor’s decision on whether to sign legislation phasing out all use.

Petition to Cancel EPA Registrations

A Petition to Cancel the registration of chlorpyrifos 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 March 29, 22017 EPA denied the Petition (See 82 Fed. Reg. 16581) although it expressly reserved decision on several issues. EPA stated that those issues would be addressed in registration review, due to be completed by 2022. Petitioners sought to overturn the denial by filing a Petition for Review in the 9thCircuit U.S. Court of Appeals. On April 19, 2019, the Court had ordered EPA to respond to the merits of the Petition within 90 days.

On July 24 EPA published its final order denying all aspects of the Petition.  EPA contends that the science addressing the risks of chlorpyrifos remains uncertain, and thus there is no legal basis for canceling the registrations and revoking the tolerances. One particular point of contention is epidemiological data developed by the Columbia University’s Center for Children’s Environmental Health and Mt. Sinai Hospital.  EPA asserts that the data is not valid, complete and reliable data unless EPA is granted access to the underlying raw data.  The study sponsors have refused to supply such information, claiming that to do so would violated subject confidentiality.

In response to the Petition denial, six states – California, Maryland, Massachusetts, New York, Vermont and Washington – have again filed a Petition for Review in the 9th Circuit U.S. Court of Appeals.

California and New York Direct Actions

Following up on its earlier announcement, the California Department of Pesticide Regulation (“CDPR”) on August 14, 2019 issued cancellation notices to all California chlorpyrifos registrants. CDPR expressly states that its decision is based upon data from five animal studies. It remains to be seen whether registrants or agricultural interests challenge the proposed cancellations.  On the same day CDPR also appointed an Alternatives to Chlorpyrifos Workgroup to address the ramifications of the withdrawal of chlorpyrifos from the market.

In New York, the legislature has 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.

The Legislature has yet to send the passed bill to the Governor. Once the bill is transmitted to the Governor, the bill must be signed within thirty days, or it will automatically lapse in a so-called “pocket veto.” 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 to a legislative action.

 

U.S. Environmental Protection Agency Determines that California Proposition 65 Cancer Warnings on Glyphosate (“Roundup®)” Labels Are Misleading; Orders Their Removal

On August 7, 2019, the U.S. Environmental Protection Agency (“EPA”) announced that it had determined that cancer warnings placed on glyphosate (“Roundup®)” labels in compliance with California’s Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65, are misleading, since EPA does not recognize the data used to determine that glyphosate is a potential carcinogen. In a letter to glyphosate registrants, EPA stated that the presence of such a misleading statement on a pesticide label renders the product misbranded, and has ordered registrants to file proposed amended labels removing the Proposition 65 statement.

The determination that glyphosate is a potential carcinogen was made by the International Agency for Research on Cancer (“IARC”), a unit of the World Health Organization. That determination in turn triggered an automatic classification as a carcinogen under Proposition 65, thereby triggering the obligation to place a cancer warning on glyphosate labels. EPA has disagreed with the IARC classification since it issuance. It issued its revised Evaluation of Carcinogenic Potential on December 17, 2017, and in April 2018, issued its final determination that glyphosate does not pose a threat of cancer.

Industry brought a successful challenge to the automatic listing, and secured a preliminary injunction preventing California from enforcing the label notice requirement.  See National Association of Wheat Growers v. Zeise,309 F. Supp. 3d 842 (EDCA February 26, 2018).  Notwithstanding the lack of enforcement, a number of labels already bore the Proposition 65 notice, which, given the nature of pesticide label regulation, cannot simply be removed.

It remains undetermined how the label amendment process will play out. The EPA letter simply requested that a proposed amended label be submitted, without specifying whether a notification pursuant to EPA Pesticide Registration Notice 98-10 will suffice, or whether a formal amendment is required. Either way this process is bound to prove cumbersome for affected glyphosate registrants.

 

 

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 LULAC matter, 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, 2019

 

EPA Obtains Stay of Execution for Chlorpyrifos from 9th Circuit Court of Appeals

 

In a rare move, on February 6, 2019, the U.S. Court of Appeals for the 9thCircuit agreed to an en bancrehearing of its decision in League of United Latin American Citizens (“LULAC”) v. Wheeler, 899 F. 3d 814 (9th Cir. 2018). That decision had ordered EPA to cancel all registrations of chlorpyrifos and revoke all chlorpyrifos domestic tolerances.

The original decision in LULACwas issued on August 9, 2018. It came some eleven years after Pesticide Action North America (“PANNA”) and the Natural Resources Defense Council filed a Petition with EPA seeking the revocation of chlorpyrifos tolerances. Since tolerances are required for the food use of pesticides, tolerance revocation would eliminate all domestic agricultural uses.  Tolerance revocation was the approach used by EPA when it sought to eliminate all food uses of carbofuran. See National Corn Growers Ass’n v. EPA, 613 F.3d 1131 (D.C. Cir. 2010).

By 2014, having received only partial responses, the Petitioners filed suit in the 9thCircuit seeking to compel a response to the Petition. That action was dismissed based upon EPA’s commitment to issue a decision by February 2014.  When a decision was not issued Petitioners again filed suit in the 9thCircuit, and were successful in having EPA ordered to issue a decision by October 2015. See In re PANNA, 798 F.3d 809 (9thCir. 2015). Because of this order, EPA proposed to revoke the chlorpyrifos tolerances. See 80 Fed. Reg. 69,080 (Nov. 6, 2015).

However, EPA did not proceed to a final action, as a result of which the 9thCircuit issued another Order requiring EPA to take final action by December 30, 2016. See In re PANNA, 808 F.3d 402 (9thCir. 2015).  Prior to taking final action on the Petition, EPA issued a revised risk assessment. See 81 Fed. Reg. 81,049 (Nov. 17, 2016). It found that the chlorpyrifos tolerances allowed aggregate exposures to chlorpyrifos which exceeded the safety standards of the Food Quality Protection Act, and thus should be revoked.

However, days before the Court-imposed deadline, EPA announced that it was denying the Petition in full. EPA stated that it found that more data was necessary to make a final decision on chlorpyrifos, and that it would complete its review of chlorpyrifos by the registration review deadline of October 1, 2022.  See 82 Fed. Reg. 16,581 (April 5, 2017).  That announcement prompted Petitioners to renew their litigation, resulting in the August 9, 2018 decision ordering the revocation of tolerances and the cancellation of registrations.

Much of the attention in the litigation has been focused on procedural issues unrelated to the actual science surrounding chlorpyrifos. EPA expended significant effort seeking to have the Court find that it did not have jurisdiction to hear the case, and there was a dissent to the August 9, 2018 decision agreeing with EPA’s position. Since EPA acts under the authority of the Food Drug and Cosmetic Act (“FFDCA”) with respect to tolerances, reviewability is determined under that statute. EPA argues that under the FFDCA the matter is not ripe for judicial review until EPA responds to comments to the April 5, 2017 publication. Plaintiffs argue that the response to comments is not jurisdictional and the case should be allowed to proceed, especially since EPA has stated that they do not intend to respond further until the final registration review position is issued, likely in 2022.

EPA was so focused on the jurisdictional issue that it offered no substantive defense on the risks of chlorpyrifos.  Of course any such defense would be hamstrung by the prior public positions supporting the tolerance revocation.  It remains to be seen whether EPA offers any substantive defense in the rehearing.

It is worth stressing again how rare a grant of rehearing en bancis. The Federal Rules of Appellate Procedure set a high standard for granting rehearings, requiring that the original panel decision either directly conflict with another decision of the 9thCircuit or another Circuit Court, or that the issues presented are of “exceptional significance.” Since there does not appear to be another Circuit decision directly at odds, by implication a majority of the active judges in the Circuit must have agreed that the FFDCA and FIFRA issues presented by this case are of such significance.

Another interesting aspect of this litigation is that the author of the LULAC was U.S. District Court Judge New Rakoff from the Southern District of New York, sitting by designation.  Judge Rakoff will not part of the en banc panel, which could shift the balance in the case. Given the time required for briefing, scheduling of argument and deliberation, it is likely that a decision will not be forthcoming until the latter half of 2019.