Guidance and Reference Materials

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

Hierarchy of viruses: enveloped, large non-enveloped, small non-enveloped

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 EPA is announcing the availability of and seeking public comment on a draft guidance document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

Details surrounding EPA's use of Regulations.gov and what docket materials are accessible on Reguations.gov.

Final Guidelines website

CFR - Code of Federal Regulations Title 21, Subpart G--General Hospital and ******Personal Use****** Miscellaneous Devices, Sec. 880.6890 General purpose disinfectants.

Guidance about the appropriate use of voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices. {Probably applies to 510(k)s}

Processes to accellerate FDA approvals, including of 510(k)s

Sept 2020. Lab and test standards and requirements.

"What factors should sponsors consider when deciding whether to change their clinical trial protocol during the COVID-19 public health emergency to include remote clinical outcome assessments?"