Federal Insecticide, Fungicide and Rodenticide Act
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note that this page refers to federal requirements. State
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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
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