Pesticide Registration (PR) Notice 00-

NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, REGISTRANTS AND APPLICATORS OF PESTICIDE PRODUCTS

This notice identifies pests of significant public health importance for the purpose of regulation under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Section 28(d) of FIFRA requires EPA, in coordination with the Department of Health and Human Services (HHS) and Department of Agriculture (USDA), to identify pests of significant public health importance and, in coordination with the Public Health Service, to develop and implement programs to improve and facilitate the safe and necessary use of chemical, biological and other methods to combat and control such pests of public health importance. Issuance of this list fulfills the requirement of FIFRA sec. 28(d) to identify pests of significant public health importance as the first step in this process.

Compilation of this list was a cooperative effort by the Department of Health and Human Services, Department of Agriculture and the EPA. The Office of Pesticide Programs, EPA, coordinated the review of experts in public health and/or pesticide use patterns to compile this list. Issuance of this list (Appendix A (17 KB, PDF) to this notice) has no effect on the regulatory status of any pesticide product. No person is required to take any action in response to this notice.

I. BACKGROUND

FIFRA section 28(d) charges EPA with identifying "pests of significant public health importance." This process is aided considerably by FIFRA definitions of two key terms. First, FIFRA expressly defines the term "pest" as meaning:

(1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organism on or in living man or other living animals) which the Administrator declares to be a pest under section 25(c)(1).

Pursuant to the authorization in the second part of this definition, EPA has broadly defined the term pest to cover each of the organisms mentioned except with respect to the organisms specifically excluded by the definition 40 CFR ¤ 152.5.

Second, although FIFRA does not define a "public health pest," it does define a "public health pesticide" and this definition supplies important information for interpreting the term "public health pest." Among other things, a "public health pesticide" must be used for "vector control or for other recognized health protection uses, including the mitigation of viruses, bacteria, or other microorganisms (other than viruses, bacteria, or other microorganisms on or in living man or other living animal) that pose a threat to public health." FIFRA sec. 2(oo) defines the term "vector" used in the above definition as "any organism capable of transmitting the causative agent of human disease or capable of producing human discomfort or injury, including mosquitoes, flies, fleas, cockroaches, or other insects and ticks, mites, or rats."

Moreover identifying pests of "significant" public health importance requires EPA to identify those FIFRA pests that are significant vectors or other significant pests affecting public health. The statute does not define what aspects of a vector render it of significant public health importance. Nonetheless, the definition of a "public health pesticide" identifies an important criterion for establishing the significance of a vector. Not only must a public health pesticide be a pesticide used for vector control, it must be a pesticide "used predominantly in public health programs." EPA believes that significant vectors can be identified by determining which vectors have been deemed sufficiently important that federal, state, or local public health programs have devoted substantial resources to their eradication.

II. THE LIST

Using the criteria in the statute, EPA has identified the pests in Appendix A of this notice. A brief description of the identified pests or category of pests and an explanation for its identification is provided below:

Cockroaches. The listed cockroaches are controlled by public housing authorities to halt the spread of asthma, allergy, and food contamination.

Body, head, and crab lice. These lice are surveyed for and controlled by public agencies to prevent the spread of skin irritation and rashes, and to prevent the occurrence of louse-borne diseases such as epidemic typhus, trench fever, and epidemic relapsing fever in the United States.

Mosquitoes. Mosquitoes are controlled by state and local public health agencies to prevent the spread of mosquitoes bearing such diseases as malaria; St. Louis, Eastern, Western, and LaCrosse encephalitis; and dengue fever.

Various rats and mice. The listed rats and mice are the subject of control programs by state and local public health agencies for the purpose of preventing the spread of rodent-borne diseases and contamination of food for human consumption.

Various microorganisms, including bacteria, viruses, and protozoans. The listed microorganisms are the subject of control programs by public health agencies and hospitals for the purpose of preventing the spread of numerous diseases.

To verify that this list was not over- or- under-inclusive, EPA undertook two separate evaluations. First, EPA considered whether in the absence of public health programs to control these pests, the pests might present a significant risk of disease or injury. EPA concluded that this was the case as to each of the pests. Second, EPA identified the universe of pests that could be categorized as public health pests and compared the risks of disease or injury posed by these pests to the pests addressed through public health programs. After reviewing the full universe of public health pests, EPA concluded that the public health program pests, in the absence of public health program control, posed a significantly higher chance of resulting in public harm than the other public health pests. Appendix A constitutes the list of significant public health pests required by FIFRA. If one particular species of mammal, insect, etc. is not listed here it does not mean it does not have public health implications.

EPA, HHS and USDA do not envision that either the list of pests of significant public health importance will necessarily remain static. It is possible in the future, as there are new discoveries concerning the roles of species in spreading disease, that this list may need to be changed. Should any additional species be found to present significant public health problems, EPA may determine that it should consider them to be pests of significant public health importance under FIFRA. As deemed necessary, the Agency will announce updates to the list of pests of significant public health importance by issuance of an updated PR Notice.

III. USE OF THE LIST OF PESTS OF SIGNIFICANT PUBLIC HEALTH IMPORTANCE BY THE AGENCY

The Agency will use the list of pests of significant public health importance to:

1. Identify pesticide products with public health uses that are used predominantly in recognized public health programs. These may include pesticides to control, attract or repel these pests.
   
   
2. Identify critical public health minor uses.
   
   
3. Together with the Public Health Service, develop and implement programs to improve and facilitate the safe and necessary use of chemical, biological and other methods to control pests of significant public health importance.

IV. PUBLIC HEALTH PESTS AND PUBLIC HEALTH PESTICIDES

As noted above, EPA will use the list of pests of significant public health importance (Appendix A) in helping to identify "public health pesticides." However, although the terms "public health pest" and "public health pesticide" are quite similar, not every pesticide used to address a public health pest qualifies as a public health pesticide. Section 2(nn) of FIFRA defines a "public health pesticide" as:

[A]ny minor use pesticide product registered for use and used predominantly in public health programs for vector control or for other recognized health protection uses, including the mitigation of viruses, bacteria, or other microorganisms (other than viruses, bacteria, or other microorganisms on or in living man or other living animal) that pose a threat to public health.

FIFRA sec. 2(oo) defines the term "vector" used in the above definition as "any organism capable of transmitting the causative agent of human disease or capable of producing human discomfort or injury, including mosquitoes, flies, fleas, cockroaches, or other insects and ticks, mites, or rats."

The above definitions spell out the three mandatory conditions for a pesticide product to qualify as a "public health pesticide."

1. The public health use of the pesticide product must be a minor use. FIFRA defines the term "minor use" in section 2(ll). In that subsection, minor uses of pesticides are defined based on both acreage and economic incentive criteria, with the latter criterion most applicable to public health pesticide products.
   
   
2. The pesticide must be registered for use and used predominantly in public health programs. EPA considers public health programs to be public programs that are funded for the express purpose of controlling public health pests. Examples include mosquito and rodent control programs, infection control programs in public hospitals, and pest control programs in public housing. For a pesticide to qualify as predominantly used in a public health program, more than half of the use of the pesticide product, taking into account all registered uses for the pesticide product, must be in a public health program.
   
   
3. The use of the pesticide in the public health program must be for vector control or for other recognized health protection purposes.

In other words, a public health pesticide is not simply a pesticide used against pests that have public health consequences; rather, a pesticide can qualify as a public health pesticide only if it is used predominantly in recognized public health programs for vector control or other public health purposes.

A public health pesticide product as defined above may be exempt from the payment of a maintenance fee under FIFRA sec. 4(i). In addition, public health pesticide product applications may be expedited. If warranted, based on the potential benefits of continued use of a pesticide for public health protection, HHS may conduct or arrange for the conduct of studies required to collect data to support continued registration or reregistration of these products.

V. WHAT REGISTRANTS SHOULD DO

Registrants do not need to do anything now in response to this notice.

VI. FOR ADDITIONAL INFORMATION

If you have questions regarding this PR Notice, contact:

Kevin Sweeney
U.S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, NW (7505C)
Washington, DC 20460
phone: (703) 305-5063
fax: (703) 305-6596
e-mail: sweeney.kevin@epa.gov

Signed:

Marcia E. Mulkey, Director
Office of Pesticide Programs, (7501C)

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