Guidance and Reference Materials

EPA Pesticide Registration Notice 2018-1

Includes exemptions & rules under Environmental Protection Agency *Minor Use Program*

*******{inc Registration Review Antimicrobials & Pesticide Re-evaluation (RED) Divisions.} Find contacts for PRIA, conventional pesticides, product registration, Registration review, FIFRA 6(a)(2), containers, storage and disposal, data submittters list, child resistant packaging

"EUPs are required for testing of pesticides indoors... This includes testing ...disinfectants under actual use conditions."

The U.S. government is providing a portal for the 2019 novel coronavirus (COVID-19) medical countermeasures task force as a single point of entry for the submission of market research packages and meeting requests from interested stakeholders.

FDA is helping to accelerate the development of COVID-19 prevention and treatment options through new guidance for innovators and researchers.

Guidance for Industry and Investigators

Emergency authorization conditions, & lists of company's products authorized so far

Explore EPA's guidance documents as defined in Executive Order 13891.

EPA News Release: EPA Meets President Trump’s Deadline, Makes Agency Guidance Available to the Public

Issued March 26, 2020 {I think expired in Aug 2020}

Coronavirus disease 2019 (COVID-19) is a virus (more specifically, a coronavirus) identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China.

(2020). “We are Alone in This Battle”: A Framework for a Coordinated Response to COVID-19 in Nursing Homes. Journal of Aging & Social Policy: Vol. 32, Older Adults and COVID-19: Implications for Aging Policy and Practice, pp. 316-322.

****!!!!****!!!!**** {510(k) exemptions for COVID.} "FDA considers chemical/physical disinfectant devices to encompass chemical disinfectant solutions used to disinfect medical devices." "Medical devices disinfectors... exempt from premarket review." "during the declared public health emergency, FDA does not intend to object to the distribution and use of sterilizers, disinfectant devices, and air purifiers that are intended to be effective at killing the SARS-CoV-2 virus but do not already have FDA marketing authorization, without compliance with the following regulatory requirements where such devices do not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) [and some other requirements]. FDA believes such devices will not create such an undue risk where the performance and labeling elements... are met." "If the device generates ozone, FDA recommends that the manufacturer evaluate whether the product is within the maximum acceptable level of ozone given in 21 CFR 801.415." [****It sounds like chlorine dioxide could be used if stays below regulated air levels. FDA has endorsed ClO2 standards for air related to food processing [ but need to check FDA's approved air concentrations for around people]. EPA has approved safety of air concentrations at specific levels around people.****]

****!!!!****!!!!**** "interpretation of the statutory and regulatory language applicable to products marketed as cleaning products that claim, state or imply that they mitigate a pest." "where a claim or implication is made in connection with the sale or distribution of a cleaning product that its use will mitigate a pest, either by itself or in combination with any other substance, the product would be considered to be intended for a pesticidal purpose and would therefore be required to be registered." "This fact sheet applies to claims made on a cleaning product’s label or labeling or through other means such as web sites, advertising, promotional or sales activities and testimonial claims in connection with sale or distribution of the product. A link on a producer’s website to academic or extension research that demonstrates the pesticidal efficacy of an unregistered product would be considered a pesticidal claim."

inc Avian Influenza 2015-2018

EPA News Release: EPA Announces Enforcement Discretion Policy for COVID-19 Pandemic

2019 Act

2013 Act

2006 Act, Public Health Emergency

...pesticide for a use authorized under a FIFRA section 18 **emergency exemption...** (40 CFR § 168.22b2). Distributor can't sponsor a

Employers are responsible for complying with PPE standards, including Respiratory Protection. However, OSHA is providing temporary enforcement flexibility. Webpage also includes Guidance, including for specific types of worker groups.

**Draft** Guidance for Industry: Flexible guidelines from FDA, Center for Biologics Evaluation and Research Center for Drug Evaluation and Research

Registered disinfectant may also be used according to label directions **against pathogens not listed on the label**

Section 18 online training