Please note that this page refers to federal requirements. State and local regulations may differ.

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)

Introduction

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) was first passed in 1947 and amended numerous times, most recently by the Food Quality Protection Act (FQPA) of 1996.   

FIFRA provides EPA with the authority to oversee the registration, distribution, sale and use of pesticides.  The Act applies to all types of pesticides, including insecticides, herbicides, fungicides, rodenticides and antimicrobials.

Note that "antimicrobials" includes disinfectants and other products (Per 40 CFR 152.10(c) bleach products, cleaning products, and deodorizers are not required to be registered under FIFRA unless they make pesticide claims.) that are intended to control microorganisms on surfaces.  FIFRA rules may apply to a wide variety of departments in healthcare facilities beyond grounds maintenance.

For completeness, the discussion below begins with a brief description of requirements the FIFRA places on pesticide manufacturers.  The following sections cover aspects of FIFRA with particular relevance for healthcare facilities.

Requirements for Pesticide Manufacturers

Product Registration

Under Section 3 of FIFRA, all pesticides (with few exceptions) sold or distributed in the United States must be registered by EPA.  Pesticide registration is very specific and generally allows use of the product only as specified on the label. Each registration specifies the use site (i.e., where the product may be used) and the amount that may be applied. The person who seeks to register the pesticide must file an application for registration. The application process often requires either the citation or submission of extensive environmental, health, and safety data.

Good Laboratory Practices

EPA prescribes good laboratory practices under 40 CFR Part 160 for conducting studies that support research or marketing permits for pesticide products regulated by EPA. These practices are intended to assure the quality and integrity of the submitted research data.

Requirements for Pesticide Users

Use Restrictions

As a part of the pesticide registration, EPA classifies the product as unclassified, general use, or restricted use (40 CFR Section 152.160(a)). The Administrator may prescribe restrictions relating to the product’s composition, labeling, or packaging.

For pesticides that may cause unreasonable adverse effects on the environment, including injury to the applicator, EPA may require that the pesticide be applied either by, or under the direct supervision of, a certified applicator.

Antimicrobials

FIFRA applies to a wide variety of sterilants, disinfectants and sanitizers used in healthcare facilities.  The definition is fairly broad, covering any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest, including microorganisms. It generally excludes products that are intended to act on organisms that are found in or on living man or animals (antibiotics, for example, are not covered under FIFRA, even though they are intended to kill certain types of microorganisms).

Products that FIFRA does cover are found throughout healthcare facilities.  Examples include disinfectants that are used on environmental surfaces (housekeeping and clinical contact surfaces).   "Clinical contact surfaces" may refer to such items as light handles, radiographic-ray heads, or drawer knobs.  "Housekeeping surfaces" may apply to floors, walls, sinks, and similar surfaces that require routine cleaning.

FIFRA requires users of products to follow the labeling directions on each product explicitly. The following statement appears on all EPA-registered product labels under the Directions for Use heading: “It is a violation of federal law to use this product in a manner inconsistent with its labeling.”  In other words, over and above the requirements of common sense, healthcare facility staff are required by law to follow the safety precautions and use directions on the labeling of each registered product.  Note in particular

  • specified dilution
  • contact time
  • method of application

Not following these or any other condition of use covered by the label would be considered misuse of the product.

There are some important pathogens for which no registered or approved products are currently available. Examples include:

  • potential terrorism agents, such as Variola major (smallpox) or Yersinia pestis (bubonic plague)
  • prions (infectious proteins), such as "mad cow disease", or Creutzfeldt-Jakob disease agents

If no registered or approved products are available for a specific pathogen or use situation, medical facilities are advised to follow the specific guidance issued by the Centers for Disease Control (CDC). Often, CDC has conferred with the EPA on appropriate products that may prove effective against these emerging pathogens.

FIFRA common areas for inspections

While an EPA inspector is authorized to examine a wide range of documents and operations, he or she will probably be particularly interested in the following features:

  • Personnel protection equipment
  • Pesticide application equipment
  • Pesticide storage areas, including storage containers
  • Cleaning disinfectants and labels

Typical records an EPA Inspector may ask to review for FIFRA compliance include:

  • Records of pesticides purchased (purchase orders, inventory)
  • Pesticide application records
  • Description of the pest control program
  • Certification status of pesticide applicators
  • Pesticide disposal manifests
  • Contract files
  • Recent ventilation rating for pesticide fume hood and pesticide mixing/storage areas

More information