EPA recently released a compliance advisory addressing pesticidal products that make claims to mitigate the novel coronavirus. While the advisory largely reiterates past guidance relating to pesticides, EPA has increased its emphasis on pesticidal devices, such as UV lights and ozone generators, which are subject to their own distinct set of regulations.
Continue Reading EPA Provides Limited Guidance Relating to Pesticidal Devices and the Coronavirus
Thomas Brugato
Thomas Brugato is a partner in the firm’s Washington, DC office. His practice focuses on environmental matters, as well as civil and administrative litigation. He has experience advising clients on a wide variety of environmental issues, including under the Clean Air Act, Clean Water Act, RCRA, CERCLA, EPCRA, TSCA, FIFRA, the Endangered Species Act, the Occupational Safety and Health Act, and EPA’s Renewable Fuel Standard program.
Thomas has extensive experience in representing companies on FIFRA matters relating to a wide range of products—such as antimicrobials, devices, treated articles, and traditional pesticides—including in EPA enforcement actions. He also has particular expertise in advising companies on a wide range of Administrative Procedure Act (APA) issues, including in litigation involving agencies in federal court. Finally, Thomas has significant experience advising clients on Indian law related issues, particularly relating to the Indian Gaming Regulatory Act and tribal sovereign immunity.
Six Highlights of EPA’s Proposal to Expand Reform of Guidance Documents
EPA on May 19 released a proposed rule that would put in place a set of regulations governing EPA’s issuance, modification, and withdrawal of guidance documents. This proposal implements portions of Executive Order 13891, and builds on EPA’s previous efforts to create a comprehensive portal of guidance documents earlier this year. Generally speaking, the stated purpose of the rule is to allow for increased transparency and public involvement in EPA’s guidance-formulation process, but the proposal also contains several key limitations.
Continue Reading Six Highlights of EPA’s Proposal to Expand Reform of Guidance Documents
Top 5 Takeaways From EPA’s New Policy on Expediting COVID-19 Disinfectant Approvals
EPA on May 12 announced a new framework for reviewing and approving products for use against the novel coronavirus. EPA’s framework explains which new product and existing product amendment requests will be expedited, and provides approximate timelines for EPA review and approval. Because of continued high demand for disinfectant products, companies seeking to launch new products or amend existing registrations should take care to ensure that their requests will receive expedited treatment. Seeking expedited treatment is particularly important given the concerns some companies have about making significant investments into EPA product registration, in light of the sometimes lengthy EPA-approval process.
Continue Reading Top 5 Takeaways From EPA’s New Policy on Expediting COVID-19 Disinfectant Approvals
EPA and CDC Urge Employers to Establish Disinfection Plans as Part of COVID-19 Reopening
EPA and the CDC on April 29 provided updated guidance on steps employers and businesses should take to disinfect their premises, as part of the “Guidelines for Opening Up America Again.” This provides important guidance for businesses to protect employees and members of the public, and to minimize potential liability arising out of coronavirus exposure in the workplace.
Continue Reading EPA and CDC Urge Employers to Establish Disinfection Plans as Part of COVID-19 Reopening
EPA Expands Flexibilities for Manufacturers of “List N” Disinfectants for Use Against Coronavirus
EPA on April 14 expanded its formal relaxation of certain FIFRA requirements for pesticides listed on EPA’s “List N” of products expected to be effective against the coronavirus. This expansion builds on EPA’s March 30 iteration of this temporary policy, which this blog previously discussed.
Continue Reading EPA Expands Flexibilities for Manufacturers of “List N” Disinfectants for Use Against Coronavirus
OSHA Issues Interim Enforcement Guidance for COVID-19
In guidance to its enforcement staff released on April 13, OSHA has re-emphasized the obligations of employers, particularly in the healthcare industry, to ensure workplace health and safety and to report illnesses and deaths relating to COVID-19 notwithstanding the pandemic. The guidance also recognizes shortages of N-95 masks and other PPE and other practical considerations that OSHA will take into account in determining whether to bring enforcement actions.
Continue Reading OSHA Issues Interim Enforcement Guidance for COVID-19
EPA Provides Flexibilities to Manufacturers of “List N” Disinfectants for Use Against Coronavirus
EPA on March 31 provided a formal relaxation of certain FIFRA requirements for pesticides listed on EPA’s “List N” of products expected to be effective against the coronavirus. This temporary policy relaxes requirements to receive EPA approval of changes in sources of certain common active ingredients—such as ethanol, hydrogen peroxide, and citric acid—in response to “reports of supply chain disruptions by pesticide registrants who manufacture disinfectant products on EPA’s List N.”
Continue Reading EPA Provides Flexibilities to Manufacturers of “List N” Disinfectants for Use Against Coronavirus
EPA Is “Especially Concerned” About FIFRA Noncompliance in Light of COVID-19 Pandemic
EPA on March 26 released a guidance document explaining its approach to enforcement actions in light of the COVID-19 pandemic. While most aspects of that document explain areas in which EPA exercising enforcement discretion to provide flexibility to regulated parties in response to the pandemic, EPA is not taking that approach with respect to antimicrobial pesticide products, including disinfectants. To the contrary, EPA made clear that it is “especially concerned about pesticide products entering the United States, or produced, manufactured, distributed in the United States, that claim to address COVID-19 impacts. The agency expects to focus on ensuring compliance with requirements applicable to these products to ensure protection of public health.”
Continue Reading EPA Is “Especially Concerned” About FIFRA Noncompliance in Light of COVID-19 Pandemic
New EPA and OSHA COVID-19 Guidance Underscore the Importance of Securing Pesticide Approval under EPA’s Emerging Viral Pathogens Policy
Under EPA’s 2016 Emerging Viral Pathogens policy, pesticide registrants can obtain EPA “pre-approval” for their product to make claims to kill emerging viral pathogens when the policy is “activated,” so long as the pesticides have been approved for use on similar viruses. These include common household and workplace disinfectant products, which are generally regulated as pesticides by EPA. The policy was activated for the first time in response to the COVID-19 outbreak, allowing certain claims to mitigate the coronavirus to be made for certain registered pesticides approved under the policy. Several recent OSHA and EPA developments underscore the importance of pesticide registrants securing approval under the policy, as well as its limitations.
Continue Reading New EPA and OSHA COVID-19 Guidance Underscore the Importance of Securing Pesticide Approval under EPA’s Emerging Viral Pathogens Policy
EPA Releases Comprehensive Guidance Database, With Significant Ramifications for Auer Deference
EPA on February 28 released a web portal containing links to “all of EPA’s active guidance documents,” as required by last year’s Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.” In total, EPA’s portal contains over 9,100 guidance documents, from EPA’s various Headquarters offices and each of its 10 Regions. EPA also notes that it withdrew a number of guidance documents “that were determined to be no longer relevant,” but has not provided a listing of such documents.
Continue Reading EPA Releases Comprehensive Guidance Database, With Significant Ramifications for Auer Deference