Federal Insecticide, Fungicide and Rodenticide
| Please note that this page refers
to federal requirements. State and local regulations
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
Requirements for Pesticide
Under Section 3 of FIFRA, all pesticides (with few
exceptions) sold or distributed in the United States must be registered by
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
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.
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.
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:
storage areas, including storage containers
disinfectants and labels
Typical records an EPA Inspector may ask to review
for FIFRA compliance include:
of pesticides purchased (purchase orders, inventory)
of the pest control program
status of pesticide applicators
- Recent ventilation
rating for pesticide fume hood and pesticide mixing/storage areas