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.

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 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.

 

 

California Identifies Cannabis Smoke and THC as Developmental Toxicants; Will Require Proposition 65 Warning for All California Sales of Products Containing Either THC or Cannabis in a Smokeable Form

As of January 2, 2021, any product sold in California which contains a measurable amount of Δ9-tetrahydrocannabinol (Δ9-THC), familiarly known as THC, will be subject to the warning requirement of California’s Safe Drinking Water and Toxic Enforcement Act of 1986, popularly known as Proposition 65. See Proposition 65.  This requirement is based upon a determination that marijuana smoke and THC in any form are teratogens, or developmental toxicants.

THC is a psychoactive cannabinoid, one of many cannabinoids contained in cannabis. Another cannabinoid, cannabidiol, known CBD and which is not psychoactive, has become wildly popular and is contained in a multitude of products making an assortment of wellness claims. Since industrial hemp, the primary source of CBD, contains trace amounts of THC (legally at a concentration of 0.3% or less), all CBD products derived from hemp are likely to contain a trace amount of THC.

At a December 11, 2019, meeting the Developmental and Reproductive Toxicant Identification Committee (“DARTIC”) of California’s Office of Environmental Health Hazard Assessment (“OEHHA”) adopted an amendment to the list of chemicals subject to notice under the act adding marijuana smoke and THC.  California Notice of Proposition 65 Listing of Marijuana Smoke and THC.  The listing was premised on a review prepared by OEHHA’s Reproductive and Cancer Hazard Assessment Branch. See Evidence on the Developmental Toxicity of Cannabis (Marijuana) Smoke and THC.

Proposition 65 warnings for products may take the form either of a warning on the label of the product, or a posted notice at the point of sale, alerting the customer (or person exposed to the product) that the product contains a teratogen. Next year CBD products sold in California will be subject to the  warning requirement. Such a warning on a CBD product with wellness claims, whether on the product label or a point-of-sale notice, stating that the product contains a teratogen, will certainly create a paradox for marketers of wellness products. Presumably the marijuana smoke warning will apply to the sale of marijuana flower, but such a warning would likely pose less of an obstacle to its sale. Social lounges where marijuana is smoked will likely follow the practice of establishments serving alcohol and post a warning sign at their entrances, 

 

New York Releases List of Disinfectants Registered in New York and Available for Use Against Novel Coronavirus SARS-CoV-2

 The SARS-CoV-2 pandemic continues to rapidly spread cases across the United States. According to the Johns Hopkins Virus Tracker, as of this writing on March 18, there have been over 205,000 cases and over 8,200 deaths worldwide.  Cases have now spread across all fifty states and the District of Columbia,  with over 6,100 reported cases and more than 100 deaths.

In response the New York State Department of Environmental Conservation has released a list of disinfectants registered in New York and available for Use against novel coronavirus SARS-CoV-2. See NYSDEC List of Disinfectants Approved for Control of SARS-CoV-2. The New York list joins the list that the U.S. Environmental Protection Agency (“EPA”) previously issued. See EPA List of Disinfectants for Control of SARS-CoV-2.  Pesticides must be registered in each state in which they are sold or distributed. Thus, while the EPA list identified Federally-registered products, those products are in fact only available in any given state if they are registered in that state.  This list identifies for New Yorkers the products on the EPA list that are actually registered in New York and thus theoretically available, subject to supply limitations.

One critical aspect of disinfectant use is often overlooked by users. All disinfectant products list minimum contact times, meaning the length of time that the surface being 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 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 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, 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 caronavirus SARS-CoV-2, the novel caronavirus 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 caronavirus.  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 which already identify a specific emerging pathogen as a target organism.  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.

One critical aspect of disinfect 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 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, 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.

EPA Announces Registration of Ten Pesticides for Use on Hemp; Still No Products Registered for Use on Cannabis

            On December 19, 2019, the U.S. Environmental Protection Agency announced the addition of hemp as a registered use for ten registered pesticides held by three registrants: Agro Logistic Systems, Marrone Bio Innovations and Hawthorne Hydroponics. These ten products, which include nine biopesticides and one conventional product, join several others already registered for use on hemp.

            The ten include the Registered biopesticides are:

Agro Logistic Systems:

 EPA registration number: 70310-5; active ingredients: azadirachtin and neem oil. Product type: Insecticide, miticide, fungicide and nematicide.

EPA registration number: 70310-7; active ingredients: Azadirachtin and neem oil. Product type: Insecticide, miticide, fungicide and nematicide.

EPA registration number: 70310-8; active ingredients: Azadirachtin and neem oil. Product type: Insecticide, miticide, fungicide and nematicide.

EPA registration number: 70310-11; active ingredient: Neem oil. Product type: Insecticide, miticide and fungicide.

Marrone Bio Innovations:

EPA registration number: 84059-3; active ingredient: Extract of Reynoutria           sachalinensis. Product type: Fungicide and fungistat.

EPA registration number: 84059-28; active ingredient: Bacillus amyloliquefaciens strain F727. Product type: Fungicide.

Hawthorne Hydroponics, dba General Hydroponics.

EPA registration number: 91865-1; active ingredients: Soybean oil, garlic oil, and Capsicum Oleoresin extract. Product type: Insecticide and repellent.

EPA registration number: 91865-3; active ingredient: Bacillus amyloliquefaciens strain D747. Product type: Fungicide and bactericide.

EPA registration number: 91865-4; active ingredient: Azadirachtin. Product type: Insect growth regulator and repellent.

The registered conventional pesticide product is:

Hawthorne Hydroponics, dba General Hydroponics:

            EPA registration number: 91865-2; active ingredient: Potassium salts of fatty acids. Product type: Insecticide, fungicide and miticide.

            When the hemp amendments were being considered, EPA had undertaken the unusual step of inviting public comment, which is not normally required for amendments such as these. The Notice prompted a number of supportive comments from a range of interests, including the U.S. Department of Agriculture, the National Association of State Departments of Agriculture, the American Farm Bureau Federation, the Bio Pesticides Industry Association and the California Department of Pesticide Regulation. With the rapidly growing number of acres planted in hemp as a result of the 2018 Farm Bill, additional registrants can be expected to seek to add hemp as a target crop, although such future amendments are not likely to be the subject of public notice.

         Despite the increased attention too hemp. EPA continues to assert that no pesticides are allowed to be used on cannabis grown for medical or adult uses.  In this regard it is interesting to note that Hawthorne Gardening  is a subsidiary of the Scotts Miracle-Gro Company, which has been quite public about its interest in expanding in the cannabis space.