U.S. 8th Circuit Court of Appeals Orders EPA to Revisit the Revocation of Chlorpyrifos Food Use Tolerances

            In an action brought by twenty trade agricultural associations and one registrant, the 8th Circuit on November 7, 2023[1]ordered EPA to revisit its August 30, 2021[2] revocation of all chlorpyrifos tolerances, which thereby eliminated all food uses.

            Chlorpyrifos, once the most used insecticide in the U.S., has been the subject regulatory concerns for decades. It is a cholinesterase inhibitor, exposure to which can cause neurological harm. In 1997 EPA reached an agreement with the major chlorpyrifos registrants to reduce residential applications and exposure. Controversy continued about the extent of the risks presented by the product. The next major event was a petition seeking revocation of all food use tolerances filed by the Natural Resources Defense Council (“NRDC”) and Pesticide Action Network North America (“PANNA”) in 2007. Without a tolerance, which determines the residue level of an ingredient that is allowed in a food product, a product may not be applied to food crops.

            After years passed without a decision, NRDC and PANNA brought a mandamus action in the 9th Circuit Court of Appeals seeking to compel EPA to issue a decision. In 2015 the Court issued a mandamus order requiring EPA to issue a decision on the petition and proposed tolerance revocations[3]. In April, 2017, EPA denied the petition and declined to revoke any tolerances[4]. Following an appeal of that order, EPA confirmed its position in 2019.[5]

            In 2020 EPA issued the Chlorpyrifos Proposed Interim Reregistration Review Decision. It found that chlorpyrifos did pose risks from certain uses and proposed to revoke certain tolerances.  After reviewing objections from various parties, EPA confirmed its decision.[6] That decision was challenged, and the 9th Circuit Court ordered EPA to revisit the remaining tolerances.[7] EPA was given sixty days to either determine those uses that could be safely continued with appropriate tolerances or revoke all tolerances. EPA determined that it was not feasible in that timeframe to assess what uses could be safely continued and revoked all tolerances. The Red River Valley Sugarbeet Growers Association action was brought in response.

            The 8th Circuit Court found that EPA’s decision to not retain specific tolerances which data suggested did not present unacceptable risks was arbitrary. The Court was not impressed by EPA’s determination that it did not have time to consider what tolerances to retain. It held that the short deadline imposed by the 9th Circuit in League of Latin American Citizens v. Regan did not justify omitting any consideration of such acceptable uses which the law required EPA to do. The Court essentially said that EPA should have worked harder and faster.

            The Court has returned the issue to EPA to reconsider the entirety of its prior revocation order. EPA documents do suggest that if it had more time previously it would have considered retaining some tolerances, so such an action might well be taken. If so it would remain to be seen how the market accommodates the restoration of such uses. The tolerance revocation did not revoke or suspend the registration of chlorpyrifos products, but it would remain to be seen how the market would respond to the restoration of any uses. It is interesting to observe that the only registrant to join the 8th Circuit action was Gharda, a generic registrant from India.   

            Reacting to the decision on February 2, 2024 EPA issued a Federal Register notice[8] reinstating the tolerances as directed by the Court. On March 15, 2024, EPA issued a product-specific notice regarding existing stocks, specifying the time periods in which products can continue to be used by growers.

            Chlorpyrifos remains under intensive review.  EPA is likely again to revoke numerous tolerances, while the product continues to undergo Registration Review.  Its future remains cloudy at best.

[1]Red River Valley Sugarbeet Growers Association et al v. Regan (8th Cir. 2023 [No. 22-1422]).

[2] 86 Fed. Reg. 48315 (August 30, 2021).

[3] In Re Pesticide Action Network N. Am., 798 F.3d 809 (9th Cir. 2015).

[4] 82 Fed. Reg. 16585 (April 5, 2017).

[5] 84 Fed. Reg. 35555 (July 24, 2019).

[6] 87 Fed. Reg. 112222 (Feb. 28, 2022).

[7] League of Latin American Citizens v. Regan, 996 F. 3d 673 (9th Cir. 2021.)

[8] 89 Fed. Reg. 7625 (February 5, 2024.)

EPA Directed by 9th Circuit Court of Appeals to Prepare New Response to Tetrachlorvinphos Cancellation Petition by August 20, 2022

In Natural Resources Defense Council v. U.S. EPA the U. S. Court of Appeals for the 9th Circuit ruled that EPA had arbitrarily denied NRDC’s petition to cancel the registration of tetrachlorvinphos, an insecticide contained in numerous prominent pet flea collars.

NRDC had filed a Petition to Cancel the registration of tetrachlorvinphos on April 23, 2009. The petition asserted that EPA had ignored serious risks, particularly to children, having concluded that the risk from such exposures was negligible and need not be assessed. NRDC conducted its own exposure studies and a risk assessment in which the estimated residues to a child exceeded safe levels. 

The petition had languished for years before NRDC brought a mandamus action seeking to compel the issuance of a response to the petition. EPA denied the petition, which NRDC challenged. The Court remanded the matter to EPA for the issuance of a revised risk assessment. EPA then compelled Hartz Mountain, the primary registrant of tetrachlorvinphos pet collars, to develop additional exposure data. When another year passed without a decision, NRDC filed a second mandamus action, based upon which the Court gave EPA ninety days to issue the revised risk assessment. EPA issued the revised risk assessment and promptly denied the Petition, following which NRDC filed a challenge to the denial.

            In reversing EPA’s denial, the Court stated:

We conclude that EPA’s denial of NRDC’s petition is not supported by substantial evidence. EPA failed to provide a reasoned explanation for its denial of NRDC’s petition and made several arbitrary calculations. EPA’s errors primarily impact two calculations central to its denial of NRDC’s petition: (1) the amount of TCVP dust released by the collars, and (2) the assumption that pet owners will trim the collars by at least 20%. Further, we cannot consider EPA’s post-hoc rationalizations, which themselves suffer from numerous flaws.

The Court found that EPA had unreasonably rejected the finding of the Hartz mountain data that significant exposure could occur, thus irrationally concluding that no risk of concern was presented by the exposure. The Court also rejected EPA’s contention that users would trim the size of the collars, thus reducing exposure.  Finally the Court rejected EPA’s additional reasons justifying the denial that were presented in the denial of the Petition.

The Court gave EPA 120 days in which to again respond to the Petition, which would put the approximate due date as August 20, 2022.  Stay tuned.

New York Legalizes Adult Use Cannabis; Legislation Addresses Pesticide and Other Environmental Requirements

            After several years during which the Legislature and the Governor were at odds, agreement was finally reached and on March 31, 2021, Governor Andrew Cuomo signed the Marihuana Regulation and Taxation Act  legalizing adult use cannabis and expanding the existing medical marihuana program. In addition to the retail dispensaries for medical and general adult use, the law authorizes all adults to cultivate limited quantities of cannabis once retail sales commence. New York thus becomes the sixteenth state to fully legalize cannabis.

            The law sets up multiple types of licenses: cultivator, processor, distributor and retailer.  Specific provision is made for small business and cooperative licensees. Current medical registered organizations are authorized to apply for adult use retail licenses, and are the only class of licensee allowed to vertically integrate cultivation, processing, distribution and retail sale under single ownership. The law establishes as the regulatory body the Cannabis Control Board within the New York State Liquor Authority.

            The Board is directed to promulgate regulations addressing  a wide variety of topics, including environmental concerns generally and pesticides specifically. In consultation with the State Department of Agriculture and Markets and Department of Environmental Conservation the Board is directed to promulgate regulations “governing the safe production of cannabis, including environmental and energy standards and restrictions on the use of pesticides and best practices for water and energy conservation.”

            The Act also identifies environmental concerns among the selection criteria for licensing. Regulations are to be promulgated which will require consideration, among other criteria, of whether an applicant has demonstrated “the ability to increase climate resiliency and minimize or eliminate adverse environmental impacts, including but not limited to water usage, energy usage, carbon emissions, waste, pollutants, harmful chemicals and single use plastics.” In addition, if the application is for an adult use cultivator or processer license, the applicant must identify “the environmental and energy impact, including compliance with energy standards, of the facility to be licensed.”

               Cultivator licensees are subject to additional requirements. Again in consultation with the State Department of Agriculture and Markets and Department of Environmental Conservation the Board is directed to promulgate regulations addressing “sustainable farming principles and practices such as organic,  regenerative,  and  integrated  pest  management models to the extent possible, and shall restrict whenever possible, the use  of  pesticides  to  those  that are registered by the department of environmental conservation or that specifically meet the  United  States environmental  protection  agency  registration  exemption  criteria for minimum risk, used in compliance with rules, regulations, standards  and guidelines  issued by  the department of environmental conservation for pesticides.”

               Finally processors of hemp, a separate license category, are required to “take  such  steps  necessary to ensure that the cannabinoid hemp or hemp extract used in their processing operation has only been grown with pesticides that are registered by the department of environmental  conservation  or that specifically meet the United States environmental protection  agency  registration  exemption  criteria  for minimum  risk, used in compliance with rules, regulations, standards and guidelines issued by the department of  environmental  conservation  for pesticides.”               

             These new requirements are actually likely to bring more transparency about the operations of all aspects of cannabis businesses than has been the case with the existing medical registered organizations. The Department of Environmental Conservation has resisted disclosing the identity of pesticides approved for use in the existing medical program. That information will now presumably become public. None of the other environmental concerns required to be addressed were ever regulated or considered in granting the ten existing medical registered organization licenses. The scope of the regulations of such factors will be determined by the rulemaking, which is bound to attract significant attention from both the industry and advocacy organizations. For example, energy requirements in Massachusetts are sufficiently rigorous such that only LED lighting is able to meet the requirements.

Court Rules that California Proposition 65 Cancer Warning on Glyphosate Products Would Unlawfully Compel Registrants to Engage in controversial Speech

A ruling this week from the U.S. District Court for the Eastern District of California held that requiring registrants of glyphosate products to be the subject of a Proposition 65 cancer warning would violate the 1st Amendment rights of such registrants.  National Association of Wheat Growers et al v. Becerra, Attorney General of California [No. 2:17-cv-2401 WBS; opinion available only through Federal PACER System.]  The Court ruled that by compelling them to engage in speech that is controversial and in the opinion of the U.S. Environmental Protection Agency (“EPA”) false would make the products misbranded would violate the registrants’ rights under the 1st amendment.

Proposition 65 requires sellers of products in California that the state has determined contain substances which are carcinogenic or teratogenic to provide warnings of exposure to such substances. Warnings can be in the form a statement on the product label or a notice placed at the point of sale.  California can make such a determination on its own but is also required under the law to accept the determinations of outside expert bodies, including EPA, the U.S. National Institute for Occupational Safety and Health (or NIOSH, a component of the Centers for Disease Control), the U.S. National Toxicology Program (or NTP which is part of the National Institutes of Health), and the International Agency for Research on Cancer (or IARC, which is the research arm of the U.N. World Health Organization (“WHO”).

The dispute in this case involves the assertion by California that glyphosate causes cancer. That determination was based upon a 2015 determination by IARC that glyphosate is a probable carcinogen. As an outside expert body whose determination is binding under Prop 65, California proceeded on July 7, 2017, to add glyphosate to the Prop 65 list and advise registrants of their obligation to comply within one year.  

The IARC determination of carcinogenicity of glyphosate is the only review that reached such an outcome. EPA has adamantly contended that glyphosate is not a carcinogen.  See EPA Review of the Carcinogenic Potential of Glyphosate.  Reviews by other international bodies, such as the European Commission for Health and Consumer Protection Directorate-General, the WHO International Programme on Chemical Safety, as well as other individual nations, such as Canada and Australia, concurred with EPA and not IARC.

A group of twelve national and state trade associations and grower groups, as well as the registrant Monsanto brought suit, and on February 26, 2018, the Court preliminarily enjoined California from enforcing the warning requirement. The issue now before the Court was whether to permanently enjoin the warning requirement for glyphosate, which it did.

The Court presented a history of the litigation over commercial speech, beginning with the U.S. Supreme Court decisions in Central Hudson Gas & Electric Corporation v. Public Service Commission  (1980) and Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio  (1988), which addressed respectively a speech limitation imposed by New York State and speech compelled by the State of Ohio. The standard established by Zauderer requires a determination by the reviewing Court that the compelled speech is factual and non-controversial. If not, then the stricter standard of review established by Central Hudson applies.

The Court found that the required notice was not purely factual and was in fact controversial, this triggering the stricter standard of review. The Court found that in the context of the professional disagreements on the carcinogenicity of glyphosate, the required warnings would be false and misleadingly imply that no dispute exists as to the issue of carcinogenicity. The Court also pointed out the irony that while EPA is an expert outside body under Proposition 65 whose position is binding, EPA has determined that placing the required warning on a pesticide would make the product misbranded, since EPA contends the statement is false.

In an effort to salvage a warning requirement, California offered a variety of alternative wordings for the warning. The Court rejected all alternatives, saying they would not adequately advise the public of the underlying scientific conflict and would still subject registrants to potential enforcement litigation brought by private parties.

It remains to be seen whether California will appeal this decision to the 9th Circuit.  If it does so the chances for success seem limited. While this decision may conclude this aspect of the controversies over glyphosate, the various tort suits alleging that glyphosate causes Parkinson’s Disease continue to wend their way through various trials and appeals.   

Meanwhile as of this writing EPA continues to refuse to allow any pesticide registrant whose product is subject to a Proposition 65 notice requirement to place such a notice on a pesticide label. This limitation was originally imposed during the litigation, but EPA gives no indication as to when or how it will address notice requirements for other ingredients  Registrants with such products are left with the unsavory choice of forging the California market or risk State or private enforcement action.

 

9th Circuit Court of Appeals Vacates Three Dicamba Over the Top Registrations; Market and Growers Thrown into Chaos

On June 3, 2020, the U.S. Court of Appeals for the 9th Circuit ruled that the U.S. Environmental Protection Agency (“EPA”) failed to adequately address the risks presented by three over the top (“OTT”) registrations of the herbicide dicamba as required by Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) and immediately vacated the registrations. See National Family Farm Coalition v. EPA [9th Cir. June 3, 2020].

The three registered dicamba products for which the registrations were cancelled are Bayer’s XtendiMax with VaporGrip Technology (EPA Reg. No. 524-617) [originally a Monsanto product], BASF’s Engenia Herbicide (EPA Reg. No. 7969-345) and DuPont’s FeXapan (EPA Reg. No. 352-913).  Because Syngenta’s Tavium Plus VaporGrip Technology (EPA Reg. No. 100-1623), also an OTT dicamba pro0duct, was not part of the 2018, two-year registration for the three affected products, it can still be used.

This decision is the latest development in a process stretching over five years. As glyphosate use had increased significantly over the prior ten years, so had weed resistance to glyphosate. As an alternative, industry began developing cotton and soybean varieties tolerant to dicamba. In 2015, the U.S. Department of Agriculture (“USDA”) deregulated dicamba-tolerant soybean and cotton seeds, while applications were still pending for the registration of dicamba for OTT use on such crops.

Dicamba-tolerant seed was quickly adopted by growers for the 2016 season, although no dicamba product was registered for use on such crops. Farmers apparently resorted to the unlawful use of existing dicamba products not labeled for such uses, and problems quickly developed. Dicamba is extremely toxic to broadleaf plants, including bushes and trees. It has an elevated tendency to drift and can volatize and move off-site after application. State Departments of Agriculture quickly began to receive numerous complaints of off-target damage.

In late 2016 EPA issued two-year time-limited registrations for the OTT versions of dicamba authorized for use on the dicamba-tolerant cotton and soybeans.  The new registrations were ostensibly of such reduced volatility that EPA found that the new formulations were “expected to eliminate any off-site exposures.”  Rapid adoption by growers of the tolerant seed and new formulation lead to a forty-fold increase in the use of dicamba on cotton and a four-fold increase in the use on soybeans in 2017, and use increased further in 2018.

EPA’s conclusions regarding off-target effects proved to be off-target themselves. Almost 1,300 complaints of off-target dicamba were received by state regulators in 2017, followed by some 1,400 complaints in 2018. It was estimated that by mid-July 2018, more than 1.1 million acres of non-tolerant soybeans had been damaged.

EPA and the registrants responded by further amending the dicamba label imposing stricter use conditions designed to limit off-target movement and issuing new two-year registrations in 2018. Despite the conditions added to the registration, EPA acknowledged that there would still be damage to sensitive crops and plants, including tree lines between fields but stated it could not quantify the expected damage. Plaintiffs in this case had challenged the 2016 registrations, but before the Court could rule EPA had replaced them with the 2018 registrations. The challenge then shifted to those registrations.

FIFRA is a cost-benefit statute which requires a balancing of interests. To issue a registration or grant an amendment, EPA must find that the registration “would not significantly increase the risk of any unreasonable adverse effect on the environment…taking into account the economic, social and environmental costs and benefits of the use of any pesticide.” The Court found that EPA failed to properly balance interests, having substantially understated three risks presented by the 2018 registrations and failed to even acknowledge three other risks. 

As to understated risks, the Court listed the following: that EPA under estimated the acreage that would be planted with tolerant seed and thus the quantity of dicamba that would be applied; that EPA discounted the volume of dicamba complaints to state agencies with no evidence supporting that conclusion; and that EPA failed to even try to quantify the amount of off-target damage that could be expected.

As to risks EPA ignored, the Court identified the following: that the OTT dicamba label directions had become so complex that it was likely they would not be complied with, which had already occurred with the less-complex 2016 label; that EPA had failed as FIFRA requires to assess potential economic impact of the damage that was likely to occur, and that EPA had ignored the social impacts of the decisions, including the damage to the farm community social structures caused by the neighbor-to-neighbor damage.

Having found the registration decisions in violation of FIFRA, the Court vacated the registrations. An immediate uproar spread through the registrant and grower communities as the decision comes right in the thick of the use season. Various state Department of Agriculture began issuing conflicting opinions as to whether sale or use of the product could continue. EPA responded by issuing the EPA Dicamba Cancellation Order. The Order allows the continued distribution and sale by commercial applicators, and the use of existing stocks in the possession of growers until July 31, 2020, which would be the end of the use season.

Plaintiffs immediately responded by filing a motion to hold EPA in contempt, asserting that under the Court’s vacatur of the registration EPA lacked legal authority to allow any continued sale or use as of the date of the Court’s opinion. On June 19 the Court denied the contempt motion. As EPA and industry interests pointed out, review of FIFRA cancellation orders is authorized in the Federal district courts, not the Courts of Appeal.  

As this issue was unfolding, both BASF and DuPont filed emergency intervention motions with the Court, claiming that they had been unaware that the decision was going to impact their registrations. Although that issue had been briefed by the plaintiffs, EPA and intervenor Monsanto, apparently neither BASF nor DuPont had followed this litigation closely enough to realize its potential implications. BASF has also filed a motion to have the Court withdraw its mandate, thus arguably creating an opening for BASF to seek to challenge the underlying decision by seeking en banc review by the full 9th Circuit. As of the writing of this article on June 22, this motion remains pending and briefing continues.

This saga is far from over.  The challenged registrations expire at the end of 2020, so EPA must again address the issues associated with these products.

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 Eases Administrative Procedures in Order to Facilitate Production of Registered Disinfectants Labeled for Use Against Novel Coronavirus SARS-CoV-2

The new coronavirus SARS-CoV-2 continues to wreak havoc across the globe. According to the Johns Hopkins Virus Trackeras of this writing on April 1, 2020, there have been over 911,000 cases and over 45,000 deaths worldwide.  Rapid spread across the U.S. continues, with more than 203,000 cases and 4,400 deaths reported. New York has by far the greatest concentration of cases and deaths, accounting for approximately fifty percent of each.

In response to supply chain problems being encountered by disinfectant registrants, the U. S. Environmental Protection Agency (EPA) has now simplified procedures for substituting ingredients in disinfectants. Registrants are already permitted to switch sources of registered active ingredients by a process known as Notification. Such actions are governed by Pesticide Registration Notice 98-10: Notifications, Non-Notifications and Minor Formulation Amendments. Normally a registrant of antimicrobial products must wait sixty days after filing a notification before distributing an EPA-registered product subject to it, unless EPA approves the notification sooner. Even before the pandemic, EPA was overburdened and often was not responding to notifications for many months.

On March 30, 2020, EPA issued Temporary Amendment to Pesticide Registration Notice 98-10.  The Amendment makes two changes to the notification process. For a select group of active ingredients that EPA considers to be commodity chemicals, registrants may now utilize non-registered sources. Previously a change to an unregistered source required a formal amendment. In addition, registrants now may distribute product subject to the notification immediately upon filing it with EPA.

The ingredients subject to this new process are: Ethanol; Hypochloric acid; Sodium hypochlorite; Hydrogen peroxide; Hypochlorous acid; Citric acid; L-lactic acid andGlycolic acid.

The substituted ingredient must the specific version of the chemical as identified by EPA by Chemical Abstract Service (CAS) number and must meet the original certified limits specified on the product’s Confidential Statement of Formula (CSF). Registrants using non-registered sources may continue to do so as long as the Temporary Amendment is in force, which at this point is undetermined. If the registrant desires to utilize an unregistered source beyond the duration of the Temporary Amendment, a formal amendment to the CSF is required.

EPA continues to update list of registered disinfectants available for use on hard surfaces for the control of the novel caronavirus SARS-CoV-2, which causes COVID-19. See EPA List of Disinfectants for Control of SARS-CoV-2. EPA also continues to expedite reviews of amendments seeking to add claims for control of SARS-CoV-2, but 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 must go through the standard amendment process.