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 the Johns 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:

> Added more products to EPA List N: Disinfectants for Control of SARS-CoV-2. The list now contains over 360 products. 

> Refined List N by adding a description of the surface(s) upon which each product may be used, identification of the target sites for which each product is labeled and identifying those products which authorize application via fogging.

> Incorporated by reference into List N lists previously identified as efficacious against other viral pathogens. These include List G: Products Effective Against Norovirus and List L: Products Effective Against Ebola Virus. 

> Expanded by forty-eight chemicals the list of commodity chemicals used as inert ingredients in approved disinfectants that may be used as alternative sources without notice to EPA.  See EPA List of Commodity Inert Ingredients

> Expanded the Frequently Asked Questions About Disinfectants Related to Coronavirus  

> Is expediting the process of securing Pesticide Company numbers and Pesticide Producing Establishment numbers.

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 Tracker as 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 and Glycolic 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 coronavirus 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.

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 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, 2020, there have been over 196,000 cases and over 7,800 deaths worldwide.  Spread across the U.S. is rapidly evolving, with more than 5,700 reported cases and 100 deaths.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

EPA 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 required only for new active ingredients. 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. In the meantime, however, EPA continues to assert that no pesticides are legal for use on cannabis being grown under state medical and adult use programs.

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.

New York to Adminstratively Eliminate All Uses of Chlorpyrifos [Updated]

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 continues to be challenged in Court by a collection of states, while California has secured the agreement of major registrants to administratively cancel all registration. Now the New York Governor has directed the Department of Environmental Conservation (“NYSDEC”) to administratively phase out most uses of the ingredient.

In New York, the legislature 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. In a somewhat contradictory move, rather than signing the legislation, the Governor vetoed it but has directed the NYSDEC to promulgate rules largely mirroring the vetoed legislation. The Governor’s Veto Message stated that pesticides should not be regulated by legislative mandate, but instead by NYSDEC on the basis of science. The Veto Message stated that NYSDEC will act to immediately ban aerial application; most remaining uses are to be eliminated by July 1, 2021.

New York has a procedurally complex rulemaking process. To propose a rule, the moving agency must first secure approval of the State Division of the Budget. A proposed rule is then published, which must be accompanied by a series of documents assessing the impacts of the proposed rule, including a Regulatory Flexibility Analysis, a Rural Area Flexibility Analysis and a Job Impact Statement. If not finalized within a year of publication, a proposed rule expires. In fact, it often consumes most of that year to arrive and publish a final rule.  To achieve the objective of immediately eliminating aerial application, NYSDEC will need to promulgate an emergency regulation, followed by a proposed permanent rule.  The emergency rule will need to be supported by a statement justifying the need for an emergency rule.

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 said, a state must still follow its own procedures and meet its own legal standards to support a rulemaking. Although EPA has concluded that chlorpyrifos does not present an unacceptable risk, that decision was arrived at in part by excluding 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. New York will be free to include that study as a basis for its action without demanding the underlying data and is likely to do so.  Bottom line: even if challenged, done correctly New York’s anticipated rule is likely to be upheld.

With chlorpyrifos on its way out in two major states, it remains to be seen whether chlorpyrifos remains on the market, regardless of the outcome of the litigation.