Antimicrobial Policy & Guidance Documents

The Registration Policy Documents section is organized to include relevant sections of the Code of Federal Regulations (as references), internal Guidance/Guidelines, Letters (containing guidance or relevant information), Protocols, Science Policy, and Templates for registrants' use.

Code Of Federal Regulations (CFR)

40 CFR part 152 & 40 CFR part 156 -- Antimicrobial Registration Requirements

40 CFR part 158 -- Data Requirements

Guidance / Guidelines

This is a response to questions concerning existing C. diff claims on antimicrobial product labels.
Barrier Products Clarification Document - Guidance on what is needed for an Agency barrier determination.

Use of the Term "Shock" on Non-pesticide Labeling (118 KB, PDF) - This document further clarifies what claims can be made for non-pesticide shock products.

Avian Influenza A - Label Guidance for Antimicrobial Pesticides Used Against Avian Influenza A

Disinfection Hierarchy & Emerging Pathogens Guidance - Guidance for the Implementation of the Emerging (or Re-emerging) Pathogens and Disinfection Hierarchy for Antimicrobial Products.

Floor Wipe Guidance - Guidance related to the registration requirements, as well as the use directions, for presaturated/impregnated floor wipe towelette products.

Guidance for AD Review of Applications for New Chemicals, New Uses, and Major Amendments - Guidance for examining applications on new chemicals, new EPA uses, and major amendments and determining how to most efficiently and productively process such applications.

Guidance on the Processing of Applications for Registration of Antimicrobial Products Intended to Mitigate Food Borne Pathogens - Guidance to establish firm time frames under which the Agency will review applications for registration of antimicrobial products intended to decrease the incidence of food borne pathogens.

Guidance for Pre-Application Meetings on New Active Ingredients, Major New Uses and Other Registration Actions - Guidance for companies wishing to meet with the EPA before submitting an application to register an antimicrobial pesticide product.

Internal Guidance for the Efficacy Protocol Review Process - This internal guidance has been developed for use by all AD staff involved in reviewing new protocols for efficacy testing. The guidance in this document is intended to decrease the overall time needed to review new efficacy protocols as well as spend fewer resources by using an outside panel of experts.

Guidance for Use of Food-Grade Shell-Egg Sanitizers - Directions for use of food-grade shell-egg sanitizers for use in federally-inspected meat and poultry facilities

Guidelines for Dental Issues - Examples of some inquiries on dental issues to which EPA has responded.

Guidance on the Registration of MUP/TGAI Products - Effective May 1, 1998, EPA changed its policies regarding the registration of manufacturing use products.

Draft Interim Guidance for Non-Residual Sanitization of Hard Inanimate Food Contact Surfaces Using Pre-Saturated Towelettes - Protocol that can be used to conduct efficacy testing to support a pre-saturated towelette registration for use on food contact surfaces. This protocol does not address use on utensils, glasses, food, containers, dishes and food processing equipment.

Letters

Timber Treatment Technologies TimberSil Products (362 KB, PDF) - This letter is in response to a request for a barrier determination for Timbersil wood products.

BISM JWOD & Skilkraft Letter - Letter providing guidance on on the use of logos associated with blind Industries and Services of Maryland (BISM), Javis-Wagner-O'Day (JWOD), and Skilkraft.

Consumer Specialty Products Association (CPSA) Fruit Graphic Letter - This letter (addressed to CSPA) provides guidance regarding the use of graphics depicting fruit on antimicrobial labels.

CSPA Germs Letter - This letter (addressed to the Consumer Speciality Products Association - CSPA) provides guidance on the use of the term "germs" on antimicrobial labeling.

HVAC - Letter concerning the use of antimicrobial products in Heating, Ventilation, Air Conditioning and Refrigeration Systems - This letter describes EPA's concerns with the use of sanitizer, disinfectant or other antimicrobial products to treat HVAC&R systems in the absence of specific HVAC&R use directions on the product label. This letter was sent to HVAC groups/associations and various users of antimicrobial pesticides (3/14/2002).

NSF Logo - Letter describing the NSF logo that can be used on pesticide labels

SC Johnson - Letter providing guidance on biofilms claims for products intended for use in the residential setting.

Shock Letter - Letter providing clarification of the use of the term “shock” in swimming pool, hot tubs, and spa products.

Treated Burlap (50KB, PDF) - Letter providing clarification of the treated articles exemption as it relates to burlap.

Wood Preservative Organic Memorandum - Memo explaining the use of the term organic with respect to pesticide products (7/10/2007).

Protocols

Initial Virucidal Effectiveness Test (102 KB, PDF) - Efficacy of pre-saturated or impregnated towelettes for hard, non-porous surface disinfection against Feline Calicivirus (FCV), a surrogate virus for Norovirus - Initial (8/19/05).

Confirmatory Virucidal Effectiveness Test (96 KB, PDF) - Efficacy of pre-saturated or impregnated towelettes for hard, non-porous surface disinfection against Feline Calicivirus (FCV), a surrogate virus for Norovirus - Confirmatory (8/19/05).

Pre-Saturated or Impregnated Towelettes Initial Virucidal Effectiveness Test (104 KB, PDF) - Virucidal effectiveness for a product used to disinfect hard, non-porous surface contaminated with Norovirus - Initial (8/19/05).

Pre-Saturated or Impregnated Towelettes Confirmatory Virucidal Effectiveness Test (101 KB, PDF) - Virucidal effectiveness for a product used to disinfect hard, non-porous surface contaminated with Norovirus - Confirmatory (8/19/05).

Virucidal Effectiveness Test Using Bovine Viral Diarrhea Virus (BVDV) As Surrogate For Human Hepatitis C Virus (76 KB, PDF) - This protocol can be used to validate effectiveness claims for a product to be used to disinfect hard surfaces contaminated with human Hepatitis C virus (HCV)

Protocol for Residual Self-Sanitizing Activity of Dried Chemical Residues on Hard Nonporous Surfaces (153 KB, PDF) - This protocol can be used to determine the residual sanitizing efficacy of antimicrobial products after application to inanimate, nonporous, non-food-contact hard surfaces after hours.

Protocols for Testing the Efficacy of Disinfectants Against Hepatitis B Virus (HBV) - As part of EPA's commitment to protect the public and also reduce animal testing, EPA has endorsed the in vitro (test tube) duck assay as the appropriate and preferred alternative to animal testing for HBV (8/25/2000).

Science Policy

Disinfectant Technical Science Section (DIS/TSS) - These documents provide a summary of current efficacy-related requirements and/or policy for a category of antimicrobial pesticide products, claims, or patterns of use.

Templates

Acute Toxicity Templates for Antimicrobial Products (70 KB, PDF) - These templates are designed to guide registrants in submitting toxicity studies for antimicrobial products. The templates included are Acute Oral, Acute Dermal, Acute Eye Irritation, Acute Inhalation, Acute Dermal Irritation, and Skin Sensitization.

Efficacy Templates for Antimicrobial Products - These templates may be used as guides by testing laboratories in formatting and summarizing efficacy study reports (3/23/2005).

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