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, 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 Webinar seeking input on developing product testing strategies on Hospital Disinfectants

The EPA plans to host a webinar June 21st between 1-3 p.m. ET to focus on the effectiveness of disinfecting agents in hospitals. The EPA is seeking input from registrants of antimicrobial products and laboratory personnel with efficacy testing responsibilities. Additional details on the webinar can be found here. To register for the webinar, you can follow this link.

After the webinar, the docket EPA-HQ-OPP-2018-0265 at www.regulations.gov will be open for comments.

 

© 2018

EPA Updates Chapters 3, 7, and 17 in the Pesticide Label Review Manual

Yesterday, the EPA updated its Pesticide Label Review Manual to streamline its contents so that stakeholders can better comprehend the current policy regarding pesticide labeling process. Specifically, chapters 3: General Labeling Requirements, 7: Precautionary Statements, and 17: Net Contents/Net Weight were adjusted. Chapter 3: General Labeling Requirements was updated to reflect changes in EPA policy regarding the location of the First Aid Statement. Details of the changes to the mentioned chapters can be found here.

 

© 2018

EPA Releases Draft Policy of Alternative Approaches for Skin Sensitization Testing

In an effort to reduce animal testing, the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) has released a draft Science Policy recommending the use of non-animal alternatives to skin sensitization testing. A Skin Sensitization test is used to evaluate whether a product causes an allergic reaction, inflammation or sensitization of the skin. The EPA currently requires submission or citation of skin sensitization data before a pesticide can be registered in the United States. This draft science policy was developed with the cooperation of several international organizations seeking valid alternative test methods and collaboration between EPA’s Office of Pesticide Programs and Health Canada’s Pest Management Regulatory.  Substantive scientific evidence supporting the efficacy of the alternative methodologies compared to animal testing exists. Internationally, the alternative approaches highlighted in the draft policy have seen success in adoption and implementation. By adopting these alternative approaches, the EPA hopes to reduce animal testing. Public comment on the draft policy is open until June 9th, 2018. More information on the draft policy can be found here.

 

© 2018

Updated: EPA Requesting Public Comment on Respirator Descriptions

EPA has proposed revisions to the respirator descriptions when required on pesticide labeling and is requesting comments from regulators, registrants, pesticide users, safety educators and other stakeholders on the changes. 

It is EPA’s goal to bring the respirator descriptions on pesticide labels into conformance with the current National Institute for Occupational Safety and Health (NIOSH) respirator language, delete outdated statements, and remove descriptions of respirators that no longer exist. Updated label language would ensure that pesticide handlers and their employers can easily obtain the information needed to identify and buy the proper respirator required for needed protection.

After considering comments, EPA will update Chapter 10, “Worker Protection Labeling,” of the Label Review Manual (LRM). After the chapter of the LRM is finalized, EPA will ask registrants submitting labels for other reasons to revise their personal protective equipment (PPE) statements to include the updated descriptions at the same time. Registrants who wish to revise only the PPE statements to incorporate the new respirator descriptions can do so by submitting a fast-track amendment with the changes. For existing products not otherwise updated, EPA will require the submission of labels with the revised descriptions of respirators during the registration review process.

The proposed label revisions can be found at Revised Respirator Section of Label Review Manual Chapter 10. Submit comments on the revised respirator section by email at opprespiratortable@epa.gov by June 11th, 2018.

—UPDATED—

The EPA extended the public commenting period for the proposed label revisions to June 11th, 2018 from May 22, 2018.

 

4/13/2018

© 2018

EPA Announces Guidance on Placement of First Aid Statements on Pesticide Labels

There has been much discussion among EPA, the states, and registrants on the placement of the First Aid Statement on pesticide product labels. In response, EPA announced the availability of a final guidance document that clarifies where this statement should appear on products labels. The guidance document is available at Docket#  EPA-HQ-OPP-2016-0545.

In summary, EPA will continue to require that Toxicity Category I products have first aid statements visible on the front panel. EPA may allow certain exceptions when reviewed and approved by the Agency. Products that are considered Toxicity Categories II and III must have these statements on a front, back, side or inside panel (any panel). First Aid statements continue to be optional for Toxicity Category IV products.

03/09/2018

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Syngenta Agrees to $550,000 EPA Pesticide Worker Protection Enforcement Settlement

Syngenta Seeds LLC (“Syngenta”), a subsidiary of Swiss agrochemical company Syngenta, reached a settlement with the EPA for violations of The Federal Insecticide, Fungicide, Rodenticide Act (“FIFRA”) Worker Protection Standard. In a Consent Agreement and Final Order (CAFO) document, Syngenta agreed to a civil penalty of $150,000 and to implement a Supplemental Environmental Project (SEP) costing no less than $400,000.

The administrative complaint filed against Syngenta alleged that seasonal workers were exposed to chlorpyrifos and permethrin before the restricted entry interval (REI) of 24 hours had passed, were not warned by Syngenta employees before entering, and were not properly decontaminated after the incident. Exposure events occurred on two occasions in 2016 and 2017. The matter came to EPA attention through a worker reporting adverse reactions after working in the Syngenta field. The complaint goes further stating that the warning sign that notifies workers of pesticide applications was folded up, obscuring its full view from the workers and Syngenta employees failed to verbally inform the workers to not enter the restricted areas.

The resulting SEP will develop and help promote use of Worker Protection Standard (WPS) Compliance Kits, and train employees on how to comply with FIFRA Worker Protection Standards. Due to most of the violations occurring in-house, the SEP will focus on training Syngenta’s full-time employees. While the CAFO does not explain how the EPA came to the $400,000 figure, it explicitly notes the $400,000 “shall not include the following categories of Respondent’s costs: Respondent’s overhead, Respondent’s additional employee time and salary, Respondent’s administrative expenses, Respondent’s legal fees, and Respondent’s costs of oversight of the contractor who will develop and implement the SEP.” More details of the CAFO can be found here.

03/05/2018

© 2018

EPA Issues Final OCSPP Test Guidelines for Antimicrobial Pesticides for Product Performance

EPA announced on February 28, 2018, the availability of three final test guidelines for antimicrobial pesticides:

1. OCSPP 810.2000 – General Considerations for Testing Public Health Antimicrobial Pesticides
2. OCSPP 810.2100 – Sterilants, Sporicides, and Decontaminants
3. OCSPP 810.2200 – Disinfectants for Use on Environmental Surfaces.

This guideline series, Series 810 – Product Performance Test Guidelines: Group B – Antimicrobial Efficacy Test Guidelines provides recommendations on the implementation of laboratory studies used to evaluate the effectiveness of antimicrobial pesticides used to help protect public health. More information and documents about the revision of the product performance guidelines can be found at www.regulations.gov, in docket EPA-HQ-OPP-2015-0276.

03/02/2018

© 2018