SECTION: IN THE NEWS

LENGTH: 5369 words

HEADLINE: PREPARED TESTIMONY OF
GEORGE WICHTERMAN
CHAIRMAN
PUBLIC HEALTH PESTICIDE WORKING GROUP
AMERICAN MOSQUITO CONTROL ASSOCIATION
BEFORE THE HOUSE COMMITTEE ON AGRICULTURE
SUBCOMMITTEE ON DEPARTMENT OPERATIONS,
OVERSIGHT, NUTRITION, AND FORESTRY SUBMITTED
AUGUST 03, 1999

BODY:


I am George Wichterman, Chairman of the Public Health Pesticide Working Group for the American Mosquito Control Association, Past President of the Florida Mosquito Control Association and Senior Entomologist with the Lee County Mosquito Control District in Fort Myers, Florida. I am also a member of the FQPA Tolerance Reassessment Advisory Committee (TRAC) representing public health vector control and a member of the Pesticide Environmental Stewardship Program (PESP) for the AMCA. Accompanying me are Mr. Joseph Kertesz, AMCA Mid Atlantic Regional Director, Hampton, Virginia, and past president of the Virginia Mosquito Control Association, and Mrs. Judy Hansen, Past President of the AMCA and current president of the New Jersey Mosquito Control Association. I want to express our appreciation to Chairman Goodlatte (R, Va) for his leadership in holding these important hearings on the implementation of the Food Quality Protection Act, especially focusing on the importance of public health pesticides in preserving and protecting our nations public health.
The American Mosquito Control Association is a non-profit international association of individuals and organization (over 2000 members) interested in mosquito and other vector control. Our mission is to provide leadership, information, and education leading to enhancement of health, and quality of life through the suppression of mosquito and other vector transmitted diseases and the reduction of annoyance levels caused by mosquitoes and other vectors and pests of public health importance.
I regret that as a member of the public health community I can not fairly report that we have made significant progress in implementing the public health provisions of the 1996 Act. Specifically, HHS has not established a home for this important program. Moreover, HHS has not sought to appropriate the funds necessary to conduct the studies to maintain the arsenal of public health pesticides we believe are necessary to fight vectorborne diseases such as encephalitis which is increasing. Without this arsenal, we are at risk of insect resistance.
Before 1996, the focus of FIFRA and EPA's pesticide program was on agricultural pesticides. Most of the multinational companies develop and expand active ingredients for their agricultural use since that is where the large volume is. Mosquito control programs use comparatively small amounts of pesticides in adulticiding and larviciding programs. The manufacturers of active ingredients historically have been reluctant to develop the aquatic toxicity and aquatic fate data required to maintain the registration of mosquito control products. Under EPA's regulations without these data, the Agency will not "reregister" the mosquito control use. If we don't have a variety of pesticides to use in our programs, we face the prospect of mosquitoes developing resistance.
One of the objectives of FQPA was to require EPA, in consultation with HHS, to consider the unique needs and benefits of public health pesticides and for HHS to conduct testing necessary to support the continued registration of public health pesticides. Congress thus envisioned HHS serving a critical role in the preservation of public health pesticides. HHS unfortunately has not stepped up to the task. With the incidence of mosquito-borne diseases increasing, placing at risk children and the elderly, an ironic development, especially since FQPA was born out of concern of children's health. I urge this Committee and Congress to remind the Secretary of HHS of the Department's role under FQPA.
IMPORTANCE OF PUBLIC HEALTH PESTICIDES
Public health pesticides and their important uses are truly unique products with enormous health benefits for our nation, our children and our senior citizens. Mosquitoborne viruses (e.g. St. Louis encephalitis, eastern equine encephalitis, western equine encephalitis, dengue, and dengue hemorrhagic fever) are increasing threats to our public health. Public health pesticides are designed to protect the public from pests such as mosquitoes, fleas, flies, cockroaches, rats, mice, ticks, bacteria, head lice and viruses. Vector- borne diseases include encephalitis, cockroach asthma, salmonellosis, legionnaire's disease, malaria, hantavirus, plague, and tularemia.
If we as a nation are going to promote public health in America, protect current and future generations, and enhance the quality of life, it is important that we protect public health pesticides products and their uses. Currently, there are not any new public health pesticides being developed by the chemical companies. As a result we can not afford to have these remaining products discontinued or eliminated, and we must make every effort to adopt a mitigation strategy so that we can retain these important uses. As public health officials from across the nation, we must have effective, yet affordable, pest control products to protect our people and our society, especially the most vulnerable segments of our population - our children and our senior citizens.
EXPEDITE THE PUBLIC HEALTH PROVISIONS OF THE FOOD QUALITY PROTECTION ACT OF 1996
The Food Quality Protection Act specified several new regulatory obligations for the Environmental Protection Agency (EPA), and the Department of Health and Human Services Department (HHS), requiring a new regulatory liaison and memorandum of understanding between the two agencies. Despite considerable effort, however, the two agencies have still not finalized a Memorandum of Understanding (MOU) or determined how this cooperative arrangement will be undertaken. We would urge both agencies to finalize these agreements so that the regulatory responsibilities are clear. EPA has taken the initiative in this regard and appointed a public health coordinator including a team of officials to address these issues with respect to FQPA; however, as noted, HHS has not implemented FQPA as we approach the third anniversary of the Act. Rather, HHS views its responsibilities under the Act as an unfunded mandate.
For more than two years, EPA, in consultation with HHS and the U.S. Department of Agriculture, has worked on the publication of a Public Health Pest List, according to the new requirements of FQPA. We would urge the EPA to expedite the publication of this comprehensive list, with a ninety day comment period, so that all public health officials could comment on the list.
In addition, section 25 (a) (1) of FIFRA calls for EPA to identify the various classes of pesticides, including agricultural, nonagricultural, and public health pesticides. If EPA is to consider the difference in concept and usage when making pesticide regulatory decisions, then the Agency must complete classifying pesticides, including public health pesticides. It would seem logical that products that include public health pests on their label could be defined as public health pesticides. Public health pesticides provide many benefits to our nation, such as preventing the spread of infectious diseases, improving the quality of our lives, and protecting our most vulnerable subpopulations such as our children and our senior citizens.

The provisions of FQPA provide that HHS should provide available benefits and use information or an analysis thereof to the EPA. It is important that EPA have the benefit of HHS's assessment during the Agency's regulatory review of public health pesticides. We would urge both agencies to work out this important exchange of benefit information.
As noted, one of the most important provisions of the FQPA called for the establishment of the Public Health Pesticide Data Collection Program. The development of these data are essential to maintain a viable mix of mosquito control products. Under FIFRA Section 4 (n), entitled Authorization of Funds to Develop Public Health Data, the new FQPA requirements authorized the appropriations of $12 million for fiscal year 1997 and future years. HHS has not requested these funds or developed a program for the development of these data, nor it is clear that such a funding request will be made in fiscal year 2001. It is important that this public health pesticide data collection program be started as quickly as possible since there are three public health pesticide products being reviewed by EPA in their pilot process and the Agency has identified data gaps for each. It has been determined by individuals within EPA and HHS that $7,000,000 would be necessary to satisfy these data requirements in order that reregistration may be completed for these compounds.
Unfortunately HHS has been unable not only to establish a home for this pesticide data collection program, but also has not provided the necessary funds to support these orphan use public health pesticide products. USDA's IR-4 program under which that Department supports residue testing to assure the continued registration and tolerances for minor crop pesticides is proof that a Department can effectively generate pesticide data important to achieve a public goal.
Many public health products will disappear if funding for the Public Health Pesticide Data Collection Program is not approved. These products, of which many are low volume, low profit, products, will be lost in the registration and reregistration process because of economic reasons. Simply, the cost of generating the necessary data to continue these registrations far exceeds the return on sales of these products. These funds could be used at land grant universities and consulting laboratories to promote research on disease carrying vectors that are important to maintaining the nation's public health.
We respectfully urge the EPA, HHS, and the Clinton Administration to collectively work together to implement the Public Health Pesticide Data Collection Program, so that the program can begin at least by the beginning of Fiscal Year 2001.
Consequently, we at AMCA believe it is important to fully implement the public health provisions of the Food Quality Protection Act,, including but not limited to the following: 1) appropriation of funds, 2) establishing a program home within HHS, 3) execution of the Memorandum of Understanding (MOU), 2) Completion of the Pest List, 3) Classification of Public Health Pesticide Products, 4) Establishment of the benefits of public health pesticides, and 5) the establishment of the Public Health Pesticide Data Collection Program with the necessary funding.
TOLERANCE REASSESSMENT AND THE IMPLEMENTATION OF FQPA
In devising a method of instituting the new health-based safety standard of FQPA, EPA has established a theoretical "risk cup" which can be thought of as a cup filled with all pesticides with a common mode of toxicity. The theoretical risk cup, however, may not have adequate space to preserve many beneficial products - particularly minor use pesticides used in the control of public health pests such as mosquitoes, ticks, flies, roaches, rats, mice, bacteria, viruses, and other disease-carrying insects. In essence, many of these currently registered uses may be lost.
FQPA decisions need to be based on a reliable data base rather than default assumptions of maximum exposure and use. AMCA believes that many a number of valuable and beneficial public health pesticides stand in jeopardy of being canceled by EPA because the Agency may be basing its determinations on overstated assumptions of pesticide usage and inflated estimates of the potential risk associated with exposure. Within the public health community, there is a growing concern that EPA is not basing its product decisions on a complete and comprehensive database. Rather there is speculation that the Agency is relying on inadequate data and overly conservative risk assumptions in determining whether certain categories of pesticides pose an unacceptable risk to human health.The widespread cancellation of a number of important public health pesticide products currently available would have a devastating impact on public health officials nationwide. By reducing or eliminating the important public health pesticide tools, public health officials will face insurmountable obstacles to protect the nation's public health, especially if there is no viable alternative. This potentially disastrous situation may be averted if the EPA bases its regulatory decisions on a complete set of information for each pesticide product. If data gaps exist for public health pesticide uses, such as exposure data, the Agency has full authority under FIFRA's Data Call-in provisions to request the generation of this much needed data.
To further facilitate the development of use data and exposure data on mosquito control products, the American Mosquito Control Association, in conjunction with EPA, put together a survey of public health pesticide uses in the mosquito control districts across the nation during the Spring of 1998. Working with EPA officials and the Biological and Economics Analysis Division (BEAD), AMCA officials designed a survey to obtain a comprehensive pattern of use for all mosquito control products. We were interested in obtaining use rates, acres treated, and how often applications were made on urban, rural, or wildlife refuge areas. We were attempting to establish use patterns, levels of exposure, and the amount of resistance that might have occurred. This study has been completed in 1998, collated by the EPA's outside contractor, and is presently being reviewed by BEAD. We are hopeful that this new use information will be helpful to the EPA when it makes it decisions about risk assessment, risk management, and risk mitigation for public health pesticide products, especially the organophosphate (OP) insecticides.
BENEFITS OF ORGANOPHOSPHATE INSECTICIDES FOR PUBLIC HEALTH
Organophosphate (OP) insecticides are one of the most widely used pesticides in the United States. For almost thirty years, these effective, yet affordable, pesticides have been utilized to control public health pests, especially mosquitoes. These pesticide products are usually applied at low dosage rates against public health pests, have low levels of exposure, and are not persistent in the environment. They are an effective part of an IPM program.
Many of the OP compounds are important pesticide tools for professional public health officials. Five OP compounds are used for mosquito control purposes. Prevention is a key element in controlling mosquitoes and the effective use of larvicides is especially cost and time efficient because immature mosquitoes are usually highly concentrated and immobile. Mosquito control districts use temephos as a larvicide to control young and immature mosquitoes. This product is especially effective against salt marsh mosquitoes and as a vector control device for St. Louis encephalitis.
It is equally important that four OP compounds are utilized as adulticides, including Chlorpyfifos, Fenthion, Malathion and Naled. Chlorpyrifos is used against adult mosquitoes throughout the United States..Fenthion is registered as a mosquito adulticide only within the State of Florida, but is used elsewhere against other public health pests. Malathion is one of the most widely used pesticides in the United States, with multiple uses for crop protection, non-agricultural uses, and public health uses. It is used for medfly eradication in Florida and California, in urban and rural areas, because of its low dosage and low exposure elements. In this decade, it has been used after numerous natural disasters, including hurricanes in the Carolinas, and after devastating Midwestern floods. And Naled has been used extensively as a public health pesticide to reduce adult mosquito populations.
Professional mosquito control officials usually utilize an Integrated Pest Management (IPM) approach, which has been endorsed by EPA, USDA, and CDC. IPM practices frequently focus on habitat modification, especially larval habitats and utilize pesticides to supplement other approaches. When pesticides are used, they are influenced by several factors such as: I) local mosquito species, 2) application requirements (air, boat, truck, and backpack), 3) time of day (pre- dawn or after sunset), 4) to minimize impact on non-target species, 5) an analysis of scientifically conducted field surveillance, 6) cost effectiveness, and 7) the threat of mosquito-borne viruses.


In view of the important role that OP compounds have for the professional mosquito control programs in the United States and the efficient and effective manner in which they are applied, it is important to retain the public health uses of OPs. But retaining only the public health uses of the OPs will not be sufficient to economically support the retention of a particular pesticide product. The low volume, low profits generated by most public health uses, compared to most crop protection uses, are an insufficient economic incentive to support the reregistration of an OP. A registrant is unlikely to spend $10 or $20 million for the reregistration of an OP, just to save the public health uses.
RESISTANCE TO PYRETHROIDS, AND THE IMPACT ON OPs
Under normal circumstances, public health pesticides fall into four classes: 1) organophosphates, 2) pyrethroids, 3) carbamates (only one labeled adulticide remains-because the registrants are not supporting the reregistrations) and 4) natural biocides. For all practical purposes, however, the pyrethroids and the organophosphates are the only ones in general use.
These pesticide products affect insects in different ways. In general, the classes of insecticides have different modes of action. Thus, each class of insecticides affects a different physiological activity in insects. This phenomenon, along with other major characteristics, is an important factor in deciding which pesticide to select for operational use. Decisions of this type are routinely made by managers of agencies responsible for protecting the public from nuisance and disease-bearing arthropods.
These same public health officials have to be alert for changes in effectiveness of the pesticide products they are using. It is not uncommon for pesticide applications to exert selection pressures on the target insect populations, in which those few with the appropriate physiological or behavioral mechanism are capable of detoxifying or otherwise escaping the effect of the pesticide and therefore, survive exposure. When this escape occurs and the selection pressure continues because of repeated applications of the same material or one with a similar mode of action, there is a gradual buildup of individuals in the insect populations that can escape the effect of the pesticide. As a result of this selection process, eventually most of the individuals in the populations can escape the effect of the pesticide. Sometimes the insecticide resistance triggered by the escape mechanism extends to the entire class of insecticide. If the entire class of insecticides can escape, then neither the specific pesticide that caused the selection, nor other members of the same class of pesticides will be effective against this species of insect.
In the United States and on a global basis, selection of this type has occurred in over 500 insects of economic importance! Often substituted pesticide products from the same classes of insecticides are initially effective, but become ineffective very rapidly because of the escape mechanism that has been selected in the target species. Under these circumstances, the entire class of insecticides rapidly becomes useless against that species because of insecticide resistance.
Occasionally the exposure of a public health pest, an insect, occurs not as a result of control measures against that specific insect, but in response to incidental exposure to insecticide applications intended for crop protection purposes. Nevertheless, the usefulness of the pesticide and/or the class of pesticide may be lost for public health use. Since there are only a few insecticides registered for public health uses, it is a very serious setback when an insecticide or class of insecticides is lost due to resistance. It takes years of research, trying thousands of compounds, before an effective insecticide is discovered, costing upwards of $50 million. Because of the enormous cost involved in finding a new insecticide, virtually none are developed specifically for public health pests. These insecticides are usually developed for crop protection purposes - frequently corn, cotton, soybeans, etc., or for household purposes. Thus only a few become labeled for public health pests.
Because of the development of resistance to one pesticide product or a class of pesticide products, it is essential that multiple classes of public health insecticides be available for attacking public health pests.
There are several practices that the user or public health official can adopt to try to delay the onset of resistance to a specific insecticide or class of insecticides. When the control measures such as biological control or source reduction are not available or are only partially effective, the single most effective approach to prevent resistance is the regular alternation of classes of insecticides. By alternating the mode of action before selection for resistance has progressed too far, it is considered possible to eliminate the few individuals already selected..
With just the organophosphate and pyrethroid classes of insecticides generally available for control of adult public health insects, the loss of either class would eliminate the possibility of managing the prevention of resistance by alternation of adulticides. Thus, if the public health uses of organophosphate compounds were lost due to EPA regulatory action, public health officials would be severely hampered because any hope of delaying and/or preventing the onset of resistance by alternating modes of action against many public health pests would be eliminated. One class (one mode of action) is simply not enough to use good pesticide stewardship by alternating modes of action.
The prolonged continuous use of the one remaining class of insecticide could be expected to produce resistance in target pest populations if some individuals exist that have the capacity to detoxify/escape the pesticide. If that event were to occur, the last effective class of insecticides would then be lost as well.
Thus, should an entire class of insecticides, such as the organophosphates, be removed from the marketplace by EPA regulatory action, the public health official's primary mechanism for preserving insecticide susceptibility among target arthropods would be severely compromised. With but limited commercial interest in the development of public health pesticide products, especially of new alternative class of insecticides with different modes of action, the ability to control the resistant adult pest will be lost.
Since there appears to be some resistance to pyrethroids in Florida, Louisiana, and Ohio, government regulatory action to remove the other alternative product may leave public health officials with a lack of pesticide tools to protect public health. It is imperative to preserve as many classes of insecticides for public health use as is possible in order to:
1. provide the level of control necessary for protection from vector- borne disease and nuisance pests; and
2. ensure that good public health pesticide stewardship can be practiced to reduce the likelihood of selection for insecticide resistance by alternating classes of pesticides to take advantage of their different modes of action within the insects' physiological detoxification and escape mechanisms.
EXEMPT PUBLIC HEALTH USES FROM RISK CUP ANALYSIS
We at the American Mosquito Control Association urge the Environmental Protection Agency to grant an exemption for public health pesticides and their uses when implementing the risk cup analysis.
The Food Quality Protection Act (FQPA) designated special consideration for public health pesticides when the Congress included the provisions of H. R. 53 (The Public Health Pesticide Protection Act), introduced by Congressmen Cal Dooley (D,Ca) and Wally Herger (R, Ca)), in H. R. 1627. Consequently, FQPA recognized the truly unique importance of public health pesticides.
First, Section 25 (a) (1) of FIFRA directs the EPA Administrator to "take into account the differences in concept and usage between various classes of pesticides, including public health pesticides, and differences in environmental risk and the appropriate data for evaluating such risk between agricultural, nonagricultural, and public health pesticides."Second, the public health pesticide provisions of FQPA also directs the EPA Administrator to consult with the Secretary of Health and Human Services "before publishing regulations under this Act (FIFRA) for any public health pesticide... In fact, the new public health pesticide provisions include several other areas of consultation between EPA and HHS.
Third, the cancellation provisions of Section 6 *b( (2( of FIFRA also requires that the Secretary of Health and Human Services "should provide available benefits and use information, or an analysis thereof," to the EPA Administrator as it considers the cancellation or change in pesticide classification for a public health pesticide product.


Fourth, under the authorization of funds to develop public health pesticide data collection (Section 4(n) of FIFRA and subsection 4(n)(3) ("Benefits to Support Family"), the EPA Administrator and the Secretary of HHS "shall make a determination whether the potential benefits of continued use of the pesticide for public health or public health purposes..." warrants the development of public health pesticide data to "support continued registration under Section 3 or reregistration under Section 4."
Because of the enormous public health benefits that result from the appropriate use of public health pesticide products, and the important role that OP compounds have for professional mosquito control programs, we at the AMCA respectfully recommend that public health pesticides be exempt from the risk cup analysis and the tolerance reassessment process.
PESTICIDE FEES
Many public health pesticides require an exemption from tolerance and will also be part of the Agency's reassessment. Importantly, many public health pesticide products contain many low volume inert ingredients, many of which may be discontinued under this proposed pricing structure. If basic manufacturers reformulate their products, they may discontinue public health uses, especially mosquito control uses.
We at AMCA believe that public health pesticide products should be exempt from any tolerance fee so that it may become economically feasible to continue the use of these important public health pesticide products. If the EPA moves ahead to implement the Tolerance Fee Proposal as it is presently drafted, we would urge this subcommittee to hold public hearings on this important issue.
There has been considerable discussion this Spring about a potential Fee for Service Program. We at AMCA are not opposed to a Fee for Service Program, but we believe that public health pesticide products should be exempt from any such program. In essence, there should be no registration fee for any new active ingredient for public health, or any fee for public health new uses. Such fees would discourage research into new uses and establish economic barriers to low volume, low profit public health pesticide products. If the Congress considers a Fee for Service Program, we would respectfully urge this subcommittee to exempt all public health pesticide products from this program.
LEGISLATIVE ACTIVITIES
On April 28, 1999, Representative Richard Pombo introduced H. R/1592, the Regulatory Fairness and Openness Act of 1999. This legislation would require EPA to prepare a written transition analysis and report identifying various assumptions or defaults used by the Agency in making tolerance decisions and non-food pesticide decisions issued during the ten year tolerance reassessment period mandated by FQPA. In addition, the bill contains provisions which would:
- Require EPA to use actual data and scientifically sound information when modifying or revoking a tolerance
- Streamline the Section 18 process
- Provide for the monitoring of the international impacts of FQPA on U.S. agricultural commodity sectors
- Direct EPA to issue, via public notice and comment, data guidelines under FIFRA and FFDCA specifying the kinds of information required to support a new or existing tolerance; and
- Establish a new permanent Pesticide Advisory Committee to advise EPA and USDA on FQPA implementation
H. R. 1592 includes additional language which interjects the concepts of benefits and economic considerations in the FQPA decision-making process. First, the bill would direct the EPA Administrator to expedite the review of a product that is likely to provide an effective, economic alternative to the use of a pesticide that has been or is likely to be removed from the market as a result of the new FQPA requirement and for which there is no currently registered effective and economical alternative for which the number of such alternatives is insufficient to avoid problems such as pest resistance.
Second, the measure would require the transition analysis report to include a determination regarding the extent to which an effective and economically alternative to the pesticidal tolerance under review has been approved and whether revocation or modification of the tolerance will result in 1) a significant shift of production within the United States, 2) an increase in imports of corresponding commodities; 3) an increase in pest control costs; 4) pest crop damage and yield loss, including quality degradation, due to the lack of an effective alternative, or 5) a disruption of domestic production of an adequate, wholesome and economical food supply.
H. R. 1592 will ensure that sound science can draw upon the best available data or allow the Agency to call-in the necessary data under their existing authority. We at AMCA believe that this legislation will assist the Agency in making decisions based on sound science not guess science. We at AMCA endorse this legislation and urge the Congress to enact this legislation.
TRAC SHOULD BE RETAINED
In April of 1999, Vice President Al Gore, at the urging of Congressmen Charles Stenholm (D, TX) and Marion Berry (D, AR), recommended a four point plan for the implementation of the FQPA. The result of these collective efforts led the EPA and USDA to establish the Tolerance Reassessment Advisory Committee. The TRAC process has worked very well, creating a balanced dialogue between stakeholders. Importantly, it included many agricultural grower groups, as well as public health officials, thus broadening the viewpoints available to EPA and USDA.
Since this TRAC format has worked so well in representing the diversified opinions concerning the implementation of the FQPA, we at AMCA urge the continuation of the TRAC or a replacement of TRAC with a different entity. There is a real need to continue a dialogue advisory committee of some kind, and we believe that TRAC or a TRAC like entity should be retained.
CONCLUSION
As an organization of over 2000 public health professionals across the nation, we at the American Mosquito Control Association are dedicated to preserving and protecting the nation's public health. It is important that public health officials have the necessary public health pesticide tools that are effective, yet affordable, pest control products, to protect our people and our nation, especially the most vulnerable segments of our population - our children and our senior citizens.
We again thank the subcommittee for holding these important public health pesticide hearings and greatly appreciate the opportunity to be included in this process. We pledge our willingness to work with this subcommittee to promote, protect, and preserve the nation's public health.
END


LOAD-DATE: August 5, 1999