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Regulating Antimicrobial Pesticides
Registration | Reregistration
Health and Safety | Related
Resources
Many of the laws,
guidance, and policies that govern EPA are contained in the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA)
as Amended in 1996, 40 Code of Federal Regulations (CFR) Parts 152,
156, & 158 (includes current
regulation & proposed revisions), and the Office of Pesticide Prevention
and Toxic Substances (OPPTS) Harmonized Test Guidelines. The additional
guidance needed for antimicrobials can be found in the links for efficacy
test guidelines, antimicrobial policy questions, and other antimicrobial
guidance. See specific antimicrobial laws and guidance documents below:
A. Registration Policy Documents - list
of policy and guidance documents to assist in registering or understanding
antimicrobial products
B. Disinfectant Technical Science Section
(DIS/TSS) Documents - for determining efficacy data requirements,
label claims, and in some cases testing requirements
Antimicrobial Registration
EPA regulates pesticides under the statutory authority of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The registration
requirements for antimicrobial pesticides differ somewhat from those of
other pesticides. For example, EPA requires special tests to ensure efficacy
of public health pesticides when the pests are invisible disease-causing
microbes, rather than insects or rodents that may be harboring disease
organisms. Similarly, determining human and ecological risks from exposure
to antimicrobial pesticides requires different types of measurements and
models than those needed for pesticides largely applied to crops and other
plants. In view of these and other differences, EPA decided that its regulations
governing pesticide registration requirements should also incorporate
special antimicrobial sections. For more detailed registration information
please see the following:
A. Registration
Kit (Basic Instruction & Forms)
B.
Label Review Manual
C. Antimicrobial
Pesticide Registration (PR) Notices
D. Registration Policy Documents
Antimicrobial Reregistration
The process of reregistration involves determining the "eligibility"
of the active ingredients (a.i.) for all pesticides originally registered
before November 1, 1984. These pesticides must be supported with a complete
scientific analysis and show that they can be used without causing unreasonable
adverse effects to human health or the environment. EPA is responsible
for the development and issuance of Reregistration
Eligibility Decision Documents (REDs) for all chemicals with mainly
antimicrobial uses. The RED document formally present the Agency's evaluation
of the data base supporting the reregistration of a pesticide (conclusions
regarding which uses are eligible for reregistration under specific condition
and requirements etc.).
Antimicrobial Health & Safety
Antimicrobials play an important role in public health and safety. While
providing health benefits of pathogen removal and, in some cases, safety
benefits of materials preservation, they also involve risks of potential
efficacy failure and exposure hazards. Its no wonder, then, that
the effectiveness and proper use of these products are of widespread concern.
See the following documents for further reading:
Consumer
Products Treated With Pesticides
Anthrax (Information
& Chemical Factsheets)
Chromated
Copper Arsenate (CCA) and Its Use as a Wood Preservative
Heating, Ventilation, Air Conditioning, and Refrigeration
Systems (HVAC)
1,4-Bis(bromoacetoxy)-2-butene
Reregistration
Pesticide Health
& Safety
Related Resources
There are several resources outside of the EPA Web site which may give
readers additional antimicrobial information sources and opinions, which
are not currently located as part of the this section of the EPA Web site.
Links outside EPA are not necessarily supported by the agency, but do
represent alternative views on subjects related to Antimicrobial pesticides.
A list of some additional sources of antimicrobial information can be
found under Other Antimicrobial Information Sources.
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