Pesticide Registration Requirements and Guidance ~US EPA
Categories of Requirements that all applicants for all categories of pesticides must complete to help you navigate the process.
Guidance and Reference Materials
Efficacy Requirements for Antimicrobial Pesticides ~EPA
Pesticides designed to control microbial pests such as viruses and bacteria must have data proving their ability to kill these pests (known as efficacy). The guidance documents on this page describe current efficacy-related requirements.
Design for the Environment & Safer Choice certification for Antimicrobial Pesticide Products ~EPA
This Web page will help you understand and get involved in the DfE pesticide pilot program for Antimicrobial Pesticide as well as find products that are approved to use the logo on the label.
Emergency Use product classifications ~FDA
FDA categories for products used in emergencies
Medical Device 510(k) registered products database ~FDA
Search for all products & establishments registered 510(k). (*Note: FDA classes disinfectants used on PPE as "Medical Devices")
Determining when to Submit a 510(k) for a Change to an Existing Device ~FDA
Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for OTC Human Use ~FDA
Issued 2016. [Effective date noted is 9/6/2017] The FDA is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water are not...
Food Code 2017, including Hand Antiseptics ~FDA
Page 50, 2-301.16 Hand Antiseptics
Pesticide Assessment Guidelines: Hazard Evaluation: Human & Domestic Animals ~NEPIS, EPA
Primary Dermal Testing procedures on pg 55
Health Effects Test Guidelines ~EPA
links to series 870 test guidelines in the docket
Health Effects Testing Guidelines ~eCFR re. EPA
eCFR 40-1-R-798 Chronic Exposure, Subchronic Exposure, Specific Organ/Tissue Toxicity, Genetic Toxicity, Neurotoxicity
Occupational Pesticide Handler Exposure Data ~EPA
Data used for evaluating exposure of workers
Waiver for Acute Dermal testing ~EPA
How to obtain waiver
Abbreviated 510(k) Program ~FDA
Framework that FDA uses when considering whether a 510(k) is appropriate for review as an Abbreviated 510(k).
Acidified sodium chlorite solutions ~U.S. Code law
Safety, etc. 21 CFR 173.325
Residual Solvents guidance, Q3C Impurities ~FDA
FDA Guidance regarding Residual Solvents from Manufacturing
ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ~CFR law
Code of Federal Regulations Title 21 Animal Drugs, Feeds & Related Products
Safety Testing of Drug Metabolites ~FDA
Designing and Conducting Toxicity Studies (FDA Redbook 2000: IV.B.1.) ~FDA
Toxicological Principles for the Safety Assessment of Food Ingredients - Chapter IV.B.1 - General Guidelines for Designing and Conducting Toxicity Studies
Nonclinical Safety Studies for Human Clinical Trials & Marketing Authorization for Pharmaceuticals M3(R2) **FAQs** ~FDA
* Specific Questions & Answers
Toxicological principles for the safety assessment of food ingredients ~FDA
revised 2007
Recommended Toxicological Testing for Food Additives ~FDA
The purpose of this document is to provide a brief summary of recommendations for the minimum toxicity tests to be performed for safety evaluation of direct food additives and color additives used in food based on their levels of concern.
Nonclinical Safety Studies for Human Clinical Trials & Marketing Authorization for Pharmaceuticals M3(R2) **Guidance Doc** ~FDA
Main guidance document
Pesticide Registration Manual ~EPA
Pesticide registration process for companies and individuals
Pesticide Registration Manual: Chapter 4 - Additional Considerations for Antimicrobial Products ~EPA
***"A product makes a public health claim if one or more of the following apply: A claim is made for control of specific microorganisms directly or indirectly infectious or pathogenic to man ... sterilant, disinfectant, virucide, sanitizer, or tuberculocide... product does not clearly state that it is intended for use only against non-public health fungi... microbiological water purifier or microbial purification system... ***A non-specific claim is made that the pesticide product will beneficially impact or affect public health at the site of use or in the environment in which applied, and the pesticide ingredients that are an active ingredient with respect to a public health microorganism and there is no other functional purpose for the ingredient in the product; or the pesticide product is similar in composition to a registered pesticide product that makes explicit antimicrobial public health claims."
Types of Registrations under FIFRA ~EPA
Federal pesticide law (the Federal Insecticide, Fungicide, and Rodenticide Act) provides for several types of registrations.
Recommendations for cleaning in Healthcare facilities in resource-limited settings ~CDC
***Recommends not using foggers, spray bottles or fumigators***
Disinfection guidance for COVID ~WHO
FDA ?generic drugs? -Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations ~FDA
Risk Evaluation and Mitigation Strategies (REMS) for high-risk medications ~FDA
REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.