Guidance and Reference Materials

Emergency Exemptions: In some situations, a particular pathogen may not be listed on the product label of an EPA-registered disinfectant. In these cases, Section 18 of FIFRA authorizes EPA to grant exemptions to Federal agencies or States to use unregistered pesticides for a limited time, if EPA determines that emergency conditions exist. If granted, such exemptions would allow the use of non-registered pesticides or the “off-label” uses of a registered pesticide for a specified time period.

Electrostatic Spray Application Directions for Use to Antimicrobial Product Registrations. Products intended for use against the SARS-CoV-2, the novel human coronavirus that causes COVID-19

Unapproved prescription drugs pose significant risks to patients because they have not been reviewed by FDA for safety, effectiveness or quality.

"Once a product is registered by the EPA it can only make claims for what it has been tested for... also true... can only be used per label directions for the applications on the label of the product. A disinfectant can also be considered a ‘broad spectrum’ disinfectant meaning it has been tested against all three categories of bacteria, fungi and viruses. Specific bacteria, fungi and viruses must be tested to make this claim." "Cleaners on the other hand are not regulated or tested by the EPA for product registration... The EPA does have a list of ingredients it approves for use as cleaners, so they do regulate some aspects of cleaners to ensure their safety" "At no time can a ‘cleaner’ ever use the word ‘removes biofilm’." "it comes down to wordsmithing and how well you can label your products to not use any phrases that EPA does not allow on non-registered products."It does not depend on the surface being cleaned (porous, non-porous, water lines etc.) but it depends on the label and if the product is making claims.""The end user would be in jeopardy if it is using a registered product off label or not as intended based on usage label directions that brought harm to its animals. " "When mislabeling of a product like that occurs the EPA always goes after the manufacturer or distributor selling the product and NOT the end user. " "It has been stated in presentations and articles over the last couple of years from some companies that ALL products used to clean water lines without animals present must be EPA registered. It has also been stated that if you use a product that is not EPA registered to clean lines without animals present that you are violating federal law and could be fined and even incur jail time if found guilty for these "crimes"...

Grants for research and development, etc

****Grants for small businesses for COVID-19 development of technologies & products.

{Relaxes procedural sequences}

*****FDA recognizes the professional judgment of veterinarians, and permits the extralabel use of drugs by veterinarians under certain conditions.

View information related to products included on EPA's List N: Disinfectants for Use Against SARS-CoV-2.

The Office of Pesticide Programs has established a self-certification program for certain product chemistry data of manufacturing-use products and end-use products produced by a non-integrated formulation system.

Chlorine & chlorine dioxide - BL, FS, GMP, Part 137, Cereal Flours Chlorine dioxide - MISC, REG, Used as an antimicrobial agent in poultry process water at a concentration not to exceed 3 ppm residual chlorine dioxide. Used as an antimicrobial agent in water used to wash fruits and vegetables that are not raw agricultural commodities at a level not to exceed 3 ppm residual chlorine dioxide - 173.300 Chlorine dioxide, stabilized - SANI, REG, For use as rinse for food processing equipment - 178.1010

There are no FDA-approved coronavirus preventions or treatments. Researchers are studying new drugs, and drugs approved for other conditions, as possible preventions or treatments for COVID-19. The language describing possible preventions or treatments can be confusing. Here’s what those terms mean.

{Also explains EPA vs FDA jurisdiction for various types of disinfectants} Expedited review for products intended for use against the SARS-CoV-2

Electronic Code of Federal Regulations (eCFR) published by the Government Publishing Office

Documents that specify methods EPA recommends to generate data submitted to EPA to support the registration of a pesticide, setting of a tolerance or tolerance exemption for pesticide residues, or the decision making process for an industrial chemical.

Explanation by US Consumer Product Safety Commission

Old doc from 2017

The Safe Drinking Water Act (SDWA) requires the U.S. Environmental Protection Agency (EPA) to conduct a review every six years of existing national primary drinking water regulations (NPDWRs) and determine which, if any, need to be revised. The purpose of the review, called the Six-Year Review,...

2020. EPA is announcing the availability of and seeking public comment on a draft guidance document

EPA authorized the use of peroxyacetic acid and hydrogen peroxide to treat regulated medical waste potentially contaminated with the causal agent of COVID-19... Public health exemptions: EPA authorized the uses of hydrogen peroxide, didecyl dimethyl ammonium chloride, isopropanol, ethanol, n-alkyl-dimethyl ethylbenzyl ammonium chloride, and n-alkyl dimethyl benzyl ammonium chloride, on hard, nonporous surfaces in health care settings

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances which are the subject of premanufacture notices (PMNs). This action would require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to...

EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA Section 5, including notice...Any person who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose, or to manufacture or process a chemical substance in a non-exempt manner for a use that EPA has determined is a significant new use, is required by TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate, before initiating the activity. EPA will review the notice, make a risk determination on the chemical substance or significant new use, and take appropriate action as described in TSCA section 5(a)(3).