[House Hearing, 108 Congress] [From the U.S. Government Publishing Office] CURRENT CHALLENGES IN COMBATING THE WEST NILE VIRUS ======================================================================= HEARING before the SUBCOMMITTEE ON ENERGY POLICY, NATURAL RESOURCES AND REGULATORY AFFAIRS of the COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED EIGHTH CONGRESS SECOND SESSION __________ OCTOBER 6, 2004 __________ Serial No. 108-274 __________ Printed for the use of the Committee on Government Reform Available via the World Wide Web: http://www.gpo.gov/congress/house http://www.house.gov/reform ______ U.S. GOVERNMENT PRINTING OFFICE 98-485 WASHINGTON : 2005 _____________________________________________________________________________ For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512�091800 Fax: (202) 512�092250 Mail: Stop SSOP, Washington, DC 20402�090001 COMMITTEE ON GOVERNMENT REFORM TOM DAVIS, Virginia, Chairman DAN BURTON, Indiana HENRY A. WAXMAN, California CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland DOUG OSE, California DENNIS J. KUCINICH, Ohio RON LEWIS, Kentucky DANNY K. DAVIS, Illinois TODD RUSSELL PLATTS, Pennsylvania JOHN F. TIERNEY, Massachusetts CHRIS CANNON, Utah WM. LACY CLAY, Missouri ADAM H. PUTNAM, Florida DIANE E. WATSON, California EDWARD L. SCHROCK, Virginia STEPHEN F. LYNCH, Massachusetts JOHN J. DUNCAN, Jr., Tennessee CHRIS VAN HOLLEN, Maryland NATHAN DEAL, Georgia LINDA T. SANCHEZ, California CANDICE S. MILLER, Michigan C.A. ``DUTCH'' RUPPERSBERGER, TIM MURPHY, Pennsylvania Maryland MICHAEL R. TURNER, Ohio ELEANOR HOLMES NORTON, District of JOHN R. CARTER, Texas Columbia MARSHA BLACKBURN, Tennessee JIM COOPER, Tennessee PATRICK J. TIBERI, Ohio BETTY McCOLLUM, Minnesota KATHERINE HARRIS, Florida ------ MICHAEL C. BURGESS, Texas BERNARD SANDERS, Vermont (Independent) Melissa Wojciak, Staff Director David Marin, Deputy Staff Director/Communications Director Rob Borden, Parliamentarian Teresa Austin, Chief Clerk Phil Barnett, Minority Chief of Staff/Chief Counsel Subcommittee on Energy Policy, Natural Resources and Regulatory Affairs DOUG OSE, California, Chairman EDWARD L. SCHROCK, Virginia JOHN F. TIERNEY, Massachusetts CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California JOHN M. McHUGH, New York PAUL E. KANJORSKI, Pennsylvania CHRIS CANNON, Utah DENNIS J. KUCINICH, Ohio NATHAN DEAL, Georgia CHRIS VAN HOLLEN, Maryland CANDICE S. MILLER, Michigan JIM COOPER, Tennessee PATRICK J. TIBERI, Ohio Ex Officio TOM DAVIS, Virginia HENRY A. WAXMAN, California Barbara F. Kahlow, Staff Director Lauren Jacobs, Clerk Krista Boyd, Minority Counsel C O N T E N T S ---------- Page Hearing held on October 6, 2004.................................. 1 Statement of: Fauci, Dr. Anthony S., Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services; Dr. Stephen M. Ostroff, Deputy Director, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Department of Health and Human Services; and Benjamin J. Grumbles, Acting Assistant Administrator, Office of Water, Environmental Protection Agency, accompanied by Adam Sharp, Associate Assistant Administrator, Office of Prevention, Pesticides, and Toxics 12 Kilpatrick, Dr. Marm, senior research scientist, the Consortium for Conservation Medicine at Wildlife Trust; Wendy Station, founder, Encephalitis Global; David Brown, Chair, integrated pest management, Mosquito and Vector Control Association of California; Joe Conlon, technical advisor, American Mosquito Control Association; Dr. Jonathan Weisbuch, director of public health, Maricopa County, AZ; and John Pape, chief epidemiologist, Colorado Department of Public Health and Environment................ 75 Letters, statements, etc., submitted for the record by: Brown, David, Chair, integrated pest management, Mosquito and Vector Control Association of California, prepared statement of............................................... 94 Conlon, Joe, technical advisor, American Mosquito Control Association, prepared statement of......................... 100 Fauci, Dr. Anthony S., Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, prepared statement of............................................... 14 Grumbles, Benjamin J., Acting Assistant Administrator, Office of Water, Environmental Protection Agency, prepared statement of............................................... 46 Kilpatrick, Dr. Marm, senior research scientist, the Consortium for Conservation Medicine at Wildlife Trust, prepared statement of...................................... 78 Ose, Hon. Doug, a Representative in Congress from the State of California, prepared statement of....................... 4 Ostroff, Dr. Stephen M., Deputy Director, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Department of Health and Human Services, prepared statement of...................................... 25 Pape, John, chief epidemiologist, Colorado Department of Public Health and Environment, prepared statement of....... 130 Sharp, Adam, Associate Assistant Administrator, Office of Prevention, Pesticides, and Toxics, information concerning new active ingredients for mosquito control................ 73 Station, Wendy, founder, Encephalitis Global, prepared statement of............................................... 84 Weisbuch, Dr. Jonathan, director of public health, Maricopa County, AZ, prepared statement of.......................... 115 CURRENT CHALLENGES IN COMBATING THE WEST NILE VIRUS ---------- WEDNESDAY, OCTOBER 6, 2004 House of Representatives, Subcommittee on Energy Policy, Natural Resources and Regulatory Affairs, Committee on Government Reform, Washington, DC. The subcommittee met, pursuant to notice, at 10 a.m., in room 2154, Rayburn House Office Building, Hon. Doug Ose (chairman of the subcommittee) presiding. Present: Representatives Ose, Miller, Tierney, and Kucinich. Staff present: Barbara F. Kahlow, staff director; Danielle Hallcom Quist, counsel; Lauren Jacobs, clerk; Megan Taormino, press secretary; Krista Boyd, minority counsel; and Cecelia Morton, minority office manager. Mr. Ose. Good morning. Welcome to today's hearing of the Government Reform Subcommittee on Energy Policy, Natural Resources and Regulatory Affairs. Today's hearing is titled ``Current Challenges in Combating the West Nile Virus.'' I want to recognize a quorum as being present. We are joined today by two very distinguished panels to discuss the West Nile virus issue. Our first panel will be composed of Dr. Anthony Fauci--is that right? Dr. Fauci. ``Fauchi.'' Mr. Ose. ``Fauchi.'' OK--Dr. Stephen Ostroff and Mr. Benjamin Grumbles, respectively, from the NIH, the CDC and the EPA. Our second panel is composed of Mr. John Pape, Dr. Jonathan Weisbuch, Mr. Joe Conlon, Mr. David Brown, Ms. Wendy Station, and Dr. Marm Kilpatrick, respectively, from the Colorado Department of Public Health and Environment, from Maricopa County, AZ, Department of Public Health, from the American Mosquito Control Association, from the Mosquito and Vector Control Association of California, from Encephalitis Global, and from the Consortium for Conservation Medicine and Wildlife Trust. It has been 5 years since public health officials diagnosed the first case of West Nile virus in the United States. Since then the virus has crisscrossed this Nation, leaving thousands sick from a debilitating form of meningitis, encephalitis and about 620 people dead. This year, while many parts of the country have a respite, people in the Southwest are fiercely combating the West Nile virus as the epidemic rages in California and Arizona. Over the last several years, the Centers for Disease Control and Prevention and the EPA have coordinated with local vector control districts and public health officials to control and eliminate mosquitoes from spreading the virus. Meanwhile the National Institutes of Health, the States and private companies have been conducting research to develop better treatments for those who suffer from encephalitis and to develop a vaccine for West Nile virus. Together with State and local officials, Federal agencies have also organized a national public education effort to encourage individual bite prevention and source reduction. Today our vector control districts are working around the clock to locate and diagnose infected dead birds and kill virus infected mosquitos before they infect people. While local health and abatement officials work tirelessly to reduce the threat posed by mosquitos, a minority of our population is using our Federal court system to insert regulatory obstacles that tend to obstruct efforts to end this epidemic. Since the Ninth Circuit decided in March 2001 that pesticide applicators required Clean Water Act National Pollutant Discharge Elimination System permits to apply aquatic pesticides to waters of the United States, California and Washington have required mosquito control professionals to obtain NPDES permits. With similar challenges pending in the Second Circuit Court, local officials await court decisions that would determine whether such permits are needed in those jurisdictions as well. In July 2003, EPA issued an interim statement and guidance memorandum to its regional offices in an effort to clarify whether pesticide applications required NPDES permits. The guidance stated EPA's position that under certain circumstances, Federal, Insecticide, Fungicide, Rodenticide Act compliant pesticide applications do not require NPDES permits for purposes of mosquito abatement. Agency guidance, however, is not binding on non-Federal entities; therefore, a few States continue to require NPDES permits because of the 9th Circuit legal precedent. Unfortunately, EPA's guidance has not protected vector control districts from citizen lawsuits under the Clean Water Act. The vector control district in Gem County, Idaho was sued under the Clean Water Act for application of pesticides to waters of the United States even after EPA decided in August 2003 that Gem County did not need an NPDES permit to conduct its mosquito abatement activities. The result of the Gem County case and other lawsuits still pending is to add legal permit application and water quality monitoring costs and uncertainties to vector control districts already strapped for funds to control mosquitoes. Moreover, in controlling mosquito born illnesses, time is of the essence, as the testimony will clarify today, and the addition of regulatory obstacles hampers the efforts of our public health officials. We must support the efforts of local officials in combating the West Nile virus, not add additional uncertainty. I strongly urge EPA to promulgate a regulation to replace its nonbinding guidance and to provide unchallengeable clarity for this issue. We need a safe harbor. We can protect people from the West Nile virus while still maintaining the health of our aquatic ecosystems. Today we will discuss these challenges and other challenges facing us in the eradication of the West Nile virus. We will hear testimony from Federal, State and local experts in an effort to gain a better understanding of why the virus continues to be a public health threat and how close we are to eliminating it and other mosquito born illnesses. I have previously introduced our two panels today. I would be pleased to recognize my friend from Massachusetts for the purpose of an opening statement. [The prepared statement of Hon. Doug Ose follows:] [GRAPHIC] [TIFF OMITTED] T8485.001 [GRAPHIC] [TIFF OMITTED] T8485.002 [GRAPHIC] [TIFF OMITTED] T8485.003 [GRAPHIC] [TIFF OMITTED] T8485.004 [GRAPHIC] [TIFF OMITTED] T8485.005 [GRAPHIC] [TIFF OMITTED] T8485.006 Mr. Tierney. Thank you, Mr. Chairman, and I want to thank you for holding this hearing on the West Nile virus. Obviously, we are all concerned because there is no available vaccine. There are no specific treatments yet known and there is not yet enough information to effectively predict what areas might be hit the hardest. Public health workers are on the front line when it comes to defending and responding, and so it is essential that those communities have the tools and the support and the resources that they need in order to be effective. Public education we are told is probably the best and most effective means of dealing with this. So I would like obviously today to hear more from our witnesses on how those educational efforts can be improved as well as other responses that might be available. And as the chairman mentioned, I know that one of the issues we are dealing with here today is how local mosquito abatement efforts, as varied as they are, will include spraying pesticides against larva and against adult populations and whether or not there can't be some reconciliation between protecting the clean waters of this country and making sure that we respond effectively to this concern of West Nile virus. I have read a lot of the materials here, and I know that there are positions on both sides. I am curious to know whether or not the initial EPA tests do in fact take into consideration the NPDES consideration with regard to clean waters and, if not, why they can't and why both of these issues aren't reconcilable. I should think that they would be. I should think that we would be able to both keep our waters clean and have the Clean Water Act lived up to and adhered to while at the same time making sure our local communities have the ability to respond in the way that they should effectively. So, Mr. Chairman, again I thank you for this hearing. I look forward to our witnesses and want to proceed as quickly as we can. Thank you. Mr. Ose. I thank the gentleman. Gentlelady from Michigan. Mrs. Miller. Thank you, Mr. Chairman. I want to thank you for holding this hearing today. You know, with so many threats that are facing our Nation today certainly the threat of disease is one that we cannot overlook. The spread of the West Nile virus is a problem that's troubled our Nation for the past 5 years. But the purveyor of this threat is a thing that's been annoying us for our entire lives, the lowly mosquito. It is hard to believe that the mosquito is the cause of all these things. Since the first case was reported in 1999 there have been 622 reported human deaths related to this virus. It is a virus that has a dire potential because it affects livestock, other animals. In my home State of Michigan we know very well, unfortunately, firsthand the dire consequences of this damaging disease. But this is an issue that's not only affected humans. As I say, livestock, other animals as well. The first case that was detected in Michigan was found in birds actually in 2001. I know I will never look at a crow the same way, either live or dead. By 2002 the virus activity had expanded to horses and then to humans, and in that year Michigan actually had 644 recorded cases of the West Nile infection, which was the second highest number of any of the States. 51 of these cases unfortunately resulted in death. In the last 2 years, the disease seems to have sort of moved to the West and to the South as well. Thus far in 2004 there have been a total of six human cases of the West Nile virus in my home State of Michigan. And even though the number of West Nile infections in the East and the Midwest has declined, fortunately, the threat certainly has not. In Michigan our officials have actually developed a comprehensive campaign to inform the public and to expand efforts to stop the spread of this virus. The State actually introduced a Web site in 2003, which is a fantastic Web site, with a focus on educating our State's citizens. This Web site also contains a diseased wildlife observation report that can be filled out by the citizen to notify the appropriate authorities of any sick or diseased birds, where they are located and what citizens actually are observing in these cases. In 2003 alone--I thought this was interesting--we had actually over 5,000, I think 5,500 cases that were reported through the Web site, which was significant. And with this new system certainly the State of Michigan is trying to take a very proactive response to this problem. We have also put together a West Nile virus working group as well to monitor the disease within our State, and after 51 deaths in only 1 year I think every resident, certainly of Michigan and now our entire Nation, are very perceptive as to the West Nile impact. So I want to thank each of the witnesses for appearing today. I am certainly looking forward to your testimony. As you see, it is something that has a very high degree of perception in my State of Michigan, and I am looking forward to what we can do to work together to avail ourselves of getting rid of this threat. Thank you, Mr. Chairman. Mr. Ose. I thank the gentlelady. Now I'd just advise the witnesses as a matter of course in our subcommittee we swear everybody in. It is not judgmental. It is just standard practice here. So if you would all rise, please, and if you have folks that are going to provide oral testimony they need to rise and be sworn in too. I just need to make sure I have who's standing where. [Witnesses sworn.] Mr. Ose. Let the record show that the witnesses all answered in the affirmative. Now we have received your written testimony, and we have reviewed it. What we do here is we are going to recognize each of you in turn for 5 minutes to summarize your testimony. I would urge you in the course of your remarks to focus on a couple of things in particular. First, the precursor conditions that lead to an outbreak of West Nile virus, heat, water, etc., the cross-species communicability of the disease, and the treatment and prevention protocols that we need to consider. Dr. Fauci, you're recognized for 5 minutes. STATEMENTS OF DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES; DR. STEPHEN M. OSTROFF, DEPUTY DIRECTOR, NATIONAL CENTER FOR INFECTIOUS DISEASES, CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND BENJAMIN J. GRUMBLES, ACTING ASSISTANT ADMINISTRATOR, OFFICE OF WATER, ENVIRONMENTAL PROTECTION AGENCY, ACCOMPANIED BY ADAM SHARP, ASSOCIATE ASSISTANT ADMINISTRATOR, OFFICE OF PREVENTION, PESTICIDES, AND TOXICS Dr. Fauci. Thank you, Mr. Chairman. I appreciate the opportunity to testify before you and the other members of the committee. I am going to focus my remarks on the NIH research efforts involved in one of the components that you mentioned; namely, the development of treatments and prevention in the form of vaccine. This first poster that I have here up on the board puts into the general context of what West Nile virus is. It is one of a rapidly growing group of diseases that we refer to as emerging and reemerging infections. An emerging is a new infection that we've never experienced before, like HIV/AIDS, SARS or nipa virus, whereas a reemerging infection is one that has been around perhaps for a very long time, but reappears in a different location and in a different form. That is the case with West Nile virus. Now the NIH has had a headstart on research endeavors with West Nile virus even before we knew it was a problem in this country, because West Nile virus falls under the category of a Flavivirus group, which includes yellow fever, dengue, Japanese encephalitis and others, for which we have had research programs for decades. So when West Nile came along, as you could see on the next slide, we markedly escalated our research resources to approach this problem with an almost tenfold increase from 1998 through 2005, and that allowed us to hit the ground running in looking for ways to intervene, particularly in the form of treatment and vaccines. With regard to our research agenda, it is multi-faceted. As I mentioned, we now have over $40 million in funding specifically for this particular endeavor of West Nile. We are doing a number of research projects, including the development of animal models. Of course, all that we do is based on fundamental basic research with application where we can do as rapidly as possible. We do some research on vector biology and control, and all are aimed at the application for the development of countermeasure in the form of vaccines, therapies and diagnostics. Let me just take a moment to point out one of the vaccine programs that's particularly exciting to us. We call it a Chimeric vaccine, named after the Greek mythological figure Chimera, which is an animal that had the body of a goat, the head of a lion and the tail of a serpent; in other words, multiple animals mythologically put together. In a vaccine approach to West Nile we did just that. Since we already had vaccines for yellow fever, which is the same general class as West Nile, we were able to take that vaccine and use molecular approaches to insert the genes of West Nile into the yellow fever or the dengue virus, which will ultimately cutoff at least several years in the vaccine development process because of this running start that we had. Next, with regard to therapies we had basic research and targeting our therapeutic approach to vulnerable components of the virus, but also a major screening program where we screened over 1,000 known drugs and compounds in our libraries to see if there's activity. Particularly interesting is a program that's ongoing now where we are passively transfusing into West Nile virus patients in the United States sera, anti-sera antibodies that we have collected from people in Israel because the baseline level of antibodies, because Israel has had a problem with West Nile before we did, that we perhaps would be able to get some degree of protection from those passively transferred antibodies. And finally, we have a vector control program that's modest in size but it is taking novel approaches to being able to figure out ways to control the principal vector, as Congressman Miller mentioned, the mosquito, which is really a very important issue with regard to West Nile as well as other diseases. We are trying to understand the role of vectors in introducing and maintaining this virus in nature as well as its transmission not only to humans but to other hosts such as horses. So finally, on this last poster, which shows the headline from last August from the Baltimore Sun, in which it talks about West Nile, both flaring and fizzling, and there's a lesson to that because, as you'll hear from Dr. Ostroff in a moment, that the epidemiology and the pattern of this disease is such that you can have a bad year 1 year and then the next year might be a modest or easy year followed by a bad year. So whatever the flares and the fizzles are, the message that we leave from the research standpoint is that we need to continue and to escalate our research endeavors to ultimately get the appropriate countermeasures, particularly in the form of safe and effective vaccines and therapies that can be safely administered to patients who suffer from West Nile. Thank you for this opportunity. I'd be happy to answer any questions later. [The prepared statement of Dr. Fauci follows:] [GRAPHIC] [TIFF OMITTED] T8485.007 [GRAPHIC] [TIFF OMITTED] T8485.008 [GRAPHIC] [TIFF OMITTED] T8485.009 [GRAPHIC] [TIFF OMITTED] T8485.010 [GRAPHIC] [TIFF OMITTED] T8485.011 [GRAPHIC] [TIFF OMITTED] T8485.012 [GRAPHIC] [TIFF OMITTED] T8485.013 [GRAPHIC] [TIFF OMITTED] T8485.014 [GRAPHIC] [TIFF OMITTED] T8485.015 Mr. Ose. Thank you, Dr. Fauci. Our next witness comes to us from the CDC, where he is the Deputy Director for the National Center for Infectious Diseases. Dr. Ostroff, welcome to our subcommittee. You're recognized for 5 minutes. Dr. Ostroff. Thank you, Mr. Chairman, and let me thank you as well for holding this hearing to discuss our current efforts to monitor and control West Nile virus. We've submitted a longer written statement for the record. As mentioned, West Nile was first detected in the United States in 1999 and therefore holds the dubious distinction of being the last of the major emerging infections detected in this country in the 20th century. Through last year there have been more than 14,000 cases reported to the CDC and so far another 1,800 have been reported this year. These are really pretty amazing statistics. For those of us who have followed the saga from the beginning, these numbers are to us much more than statistics. Each represents a name and a face, including people who have experienced very severe illness, some lying in coma for weeks, some paralyzed for months to years. And as was mentioned, for more than 600 of these persons this infection was tragically fatal. Our hearts and prayers go out to all of these individuals who developed this disease and to the families of those who didn't survive. This commits us to working each and every day to try to prevent additional cases from occurring. West Nile's natural host is birds. Migratory birds carry it from place to place and mosquitos transmit it from bird to bird. Sometimes instead of biting another bird the mosquitos bite a horse or a human, transmitting the virus to them instead. It is unlikely that we will ever know how the virus was actually introduced into the United States in 1999. In the first poster you'll see since its introduction West Nile's march across the country has been very steady and relentless. It has swept across the entire continent, leaving wave after wave of illness in its wake during the summer mosquito season. Next poster. In its first 3 years its impact was fairly modest, but in 2002 as it moved into the Midwest case counts exploded. In the following year the case numbers doubled as the virus moved into the high plains and the Rocky Mountain States. Next poster. 2004 brings both bad and good news. The bad news is that the virus has continued its western movement principally impacting the Southwest and far West, with Arizona and California being most affected. The good news in the next poster is that the overall disease burden is down significantly from last year, with the number of cases and deaths about half of what we saw at the same time last year. In addition, in the next poster, illness seems to have peaked quite early in Arizona and has been on the decline ever since. Trends in California are less clear, but appear to be following a similar trend. CDC has been at the forefront of the efforts to respond to the challenge of West Nile virus in concert with our partners at the State and local level. Our efforts have been multi- faceted. First, using funds allocated by Congress, we have supported all States to conduct West Nile monitoring, not only for human illness but also for the presence of the virus in birds, mosquitos and other animals. Only by knowing when and where the virus is present can steps be taken to control it. This effort also revealed unknown routes of transmission, including blood transfusion, leading to rapid steps to protect the blood supply. Starting only last year, we now screen more than 12 million units annually and we estimate that this effort has prevented more than 1,000 West Nile infected units from being transfused. Second, we have developed diagnostic tests for West Nile and provided them to public health labs throughout the country to speed accurate diagnosis. Third, we have supported academically based research to address how West Nile survives and spreads, to evaluate the impact of control measures and to optimize these measures. We have also supported academic programs to train experts in mosquito control. Fourth, we have provided extramural funds to develop model guidelines for sustainable State and local mosquito control programs. In this poster you'll see we've also developed guidelines on all aspects of West Nile prevention and control and update them annually with public health and academic partners. These guidelines emphasize the fundamentals of mosquito transmitted disease prevention and control in this country: Namely, one, integrated pest management to reduce habitat where mosquitos breed, treat habitats to keep mosquitos from hatching into adults, and control adult mosquitos if they do hatch through EPA approved products; second, educate providers to appropriately diagnose and treat West Nile; and, third, as seen in the next poster, educate the public about what they can do to avoid exposure to West Nile. Shown here are some examples of posters produced by our partners at the State and local level. They emphasize several important messages: One, reduce breeding sites around the home; two, properly screen windows and doors; three, use DEET containing insect repellent when outdoors; four, reduce skin exposure by wearing long sleeves and pants; and, five, for those at the highest risk of severe disease, such as the elderly, avoid outdoor activities during peak dawn and dusk biting periods. West Nile has taught us many lessons. It has shown us that we won't be complacent about mosquito control in this country. We don't know what the future holds for this infection, but we do know that everywhere that West Nile has shown up it continues to produce disease season after season. As new vaccines and therapeutics become available for West Nile, we will still need to control and avoid mosquitos. Everyone needs to do their part not only today but also in the future. Thank you, and I'll be happy to take any questions. [The prepared statement of Dr. Ostroff follows:] [GRAPHIC] [TIFF OMITTED] T8485.016 [GRAPHIC] [TIFF OMITTED] T8485.017 [GRAPHIC] [TIFF OMITTED] T8485.018 [GRAPHIC] [TIFF OMITTED] T8485.019 [GRAPHIC] [TIFF OMITTED] T8485.020 [GRAPHIC] [TIFF OMITTED] T8485.021 [GRAPHIC] [TIFF OMITTED] T8485.022 [GRAPHIC] [TIFF OMITTED] T8485.023 [GRAPHIC] [TIFF OMITTED] T8485.024 [GRAPHIC] [TIFF OMITTED] T8485.025 [GRAPHIC] [TIFF OMITTED] T8485.026 [GRAPHIC] [TIFF OMITTED] T8485.027 [GRAPHIC] [TIFF OMITTED] T8485.028 [GRAPHIC] [TIFF OMITTED] T8485.029 [GRAPHIC] [TIFF OMITTED] T8485.030 [GRAPHIC] [TIFF OMITTED] T8485.031 [GRAPHIC] [TIFF OMITTED] T8485.032 [GRAPHIC] [TIFF OMITTED] T8485.033 [GRAPHIC] [TIFF OMITTED] T8485.034 [GRAPHIC] [TIFF OMITTED] T8485.035 Mr. Ose. Thank you, Dr. Ostroff. Our third witness on the first panel is Mr. Benjamin Grumbles. He's the Acting Assistant Administrator for Water at the U.S. Environmental Protection Agency. Sir, welcome. Mr. Grumbles. Thank you. Mr. Ose. Welcome back. Nice too see you. You're recognized for 5 minutes. Mr. Grumbles. Thank you, Mr. Chairman and Congresswoman Miller. It is an honor and a pleasure to be here to represent EPA. I am the Acting Assistant Administrator for the Office of Water, and I am joined by Adam Sharp, who is the Associate Administrator for the Office of Prevention, Pesticides and Toxics. Mr. Ose. If I recall, he was one of those who rose to be sworn in. Mr. Grumbles. Yes, that's correct. Mr. Ose. Thank you. Mr. Grumbles. And Adam also has formerly served as the Acting Counselor on Agricultural Issues for the Administrator, so he brings a wealth of knowledge to the table. Mr. Chairman, I would like to talk briefly about the role of the EPA in ensuring the protection of public health and the environment, particularly in the context of mosquito control and pesticide and clean water programs. I'd like to ask that the prepared testimony be entered as part of the record. Mr. Ose. Without objection. [The prepared statement of Mr. Grumbles follows:] [GRAPHIC] [TIFF OMITTED] T8485.036 [GRAPHIC] [TIFF OMITTED] T8485.037 [GRAPHIC] [TIFF OMITTED] T8485.038 [GRAPHIC] [TIFF OMITTED] T8485.039 [GRAPHIC] [TIFF OMITTED] T8485.040 [GRAPHIC] [TIFF OMITTED] T8485.041 [GRAPHIC] [TIFF OMITTED] T8485.042 [GRAPHIC] [TIFF OMITTED] T8485.043 [GRAPHIC] [TIFF OMITTED] T8485.044 Mr. Grumbles. I would like to note that when my staff prepared the talking points for that they had a parenthetical after that said ``pause,'' and I looked at that and I thought it said ``applause.'' And as a former committee staffer, I know that what really was an applause line was when the witness asked for their whole eloquent statement to be submitted for the record. So I appreciate that. I would just like to focus on a couple of points. One is the role of the agency in the registration of pesticides and carrying out the responsibilities under FIFRA. But I want to focus on integrated pest management. Then I also want to mention the integration of the statutes, FIFRA and the Clean Water Act. Congressman Tierney talked about the need to reconcile the two statutes and we feel that it is a positive effort to integrate the statutes to get both protection of public health and the environment and to do so in a responsible way. Also, integrated pest management, certainly EPA feels very strongly that is an appropriate path, that is the right approach. This means effective and environmentally sensitive management of pesticides using common sense measures. It involves going through a process where we really focus in on the source for the potential spread of the disease, and that often means habitat alteration and looking at those issues of standing water and things of that type. It is also very important to focus in on the early stages, whether it is the egg or the pupa or the larva, as the prime opportunity to eradicate and prevent the spread of adult mosquitos and the disease. We take very seriously our responsibilities under FIFRA and the importance and the safeguards that the registration and reregistration and labeling process provide for both effective use of pesticides to protect public health and the environment and also ensuring enforceable and appropriate environmental safeguards. On the integration issue that you raised in your statement regarding the Clean Water Act, the agency did in fact issue a guidance. It was effective immediately, July 11 of last year, and it is important to emphasize that the guidance says: and we believe it is clear--that in certain situations Clean Water Act permits--NPDES permits--are not required and that the basis for that and the whole intent there is to make sure that the statutes are integrated and not always dueling or requiring two Federal approvals. We don't want to stand in the way of appropriate use of pesticides. So the guidance specifically says that for the direct application of pesticides, direct application to waters of the United States, in accordance with all the relevant requirements under FIFRA. In that situation you do not need a Clean Water Act permit. Also, in application directly over waters such as to control for aerial spraying like over the canopy of a forest, or also aerial spraying for, you know, adulticide, to nip that problem in the bud. Again, if that's carried out in accordance with FIFRA--all relevant FIFRA requirements--our view, our interpretation of the Clean Water Act is that a NPDES permit is not required. We also issued guidance in September last year, the general counsel of the agency, addressing other cases and situations about point sources and when is and isn't a pesticide a point source. The last point I want to make, Mr. Chairman, is that we continue to focus on reviewing the various facts and circumstances, making sure that guidance and the comments we have received on that guidance are reviewed. We are committed to ensuring through partnerships with other Federal agencies and through our Clean Water Act and FIFRA program responsibilities that we have a system where we have both protection and public health in the environment and not dueling programs or statutes. Thank you, Mr. Chairman. Adam and I'd be happy to respond to any questions you or your colleague may have. Mr. Ose. Thank you. I appreciate your attendance and participation. I am going to go ahead and claim time. I want to go back to your July 11 guidance. Now, it is my understanding that guidance document was issued in the context of Altman v. Town of Amherst. In that case, the court opined that EPA needed to articulate a clear interpretation of the law. Since the guidance was issued, we still have a little bit of a divergence between how some States are treating EPA's guidance, and how others, in particular the States of Washington and California, have maintained that under the Talent case the Ninth Circuit's decision still requires them to get an NPDES permit for application of the chemical. The first question I have is do you agree with California and Washington's decision to mandate NPDES permits for use of pesticides to combat the West Nile virus? Mr. Grumbles. Mr. Chairman, I respect their decision to mandate permits. I don't believe that they are legally required and our interpretation of the statute in the Talent case and the other cases, coupled with our guidance, we believe that it is their discretion to choose to issue permits for pesticide applications. But it is not our interpretation that they are legally required or mandated to do that. Mr. Ose. And again, this is for the very narrow purpose of mosquito abatement? Mr. Grumbles. Right. And specifically, for the--what I am referring to is the two situations that we squarely address in our interim guidance. That is the direct application to waters of the United States of pesticides, and also application directly over waters such as when you have adulticides that you're spraying or---- Mr. Ose. So there's two different tests there at least. There's the mosquito abatement purpose and then there's the waters of the United States or the aerosol treatment over waters of the United States or in a canopy. Mr. Grumbles. I think rather than focusing just on the purpose, it is the actual use. I mean, we want to make sure that we look not just to what the purpose of the applicator is, but how the applicator ends up following through on that purpose. If they use their pesticide, apply it in accordance with all relevant FIFRA requirements and it is in the context of a direct application to waters, or an application of pesticides directly over waters of the United States, then we believe a NPDES clean water permit is not required. Mr. Ose. All right. I guess one of the questions I have is, at least in California, native of California who lives in California. I noticed on one of the maps up there the dot matrix or the tracking system from 1999 to 2003. Frankly, the map didn't show a large population in California as yet. I am trying to get to some degree of certainty that my State can have a reasonable chance of forestalling an outbreak of this disease. Now, how do we reconcile EPA's determination, which arguably is very narrow in scope, with California's basis for requiring an NPDES permit? There's some sort of disconnect and I don't quite understand what it is. Is it based on the Ninth Circuit's determination? Or is it something beyond that, that's not legally driven but driven perhaps from the State level? Mr. Grumbles. I think it may be a combination of things, Mr. Chairman. Our view is that the interim guidance does specifically address not just the Altman case in New York, but also the Talent case, that situation. Now, one of the most important components here to keep in mind is that the Clean Water Act, a bedrock principle of the statute, is that the States always have the flexibility to have additional requirements that are more protective than, are broader in scope than the Federal requirements. I think there is a conscious effort by the State to choose to interpret the guidance and also to use the permits, the general permits or a permitting program as a tool in their toolbox. So I think that there are a variety of factors that are in play there. Our basic position, Mr. Chairman, is that when you look at those situations, direct application into waters of the United States of pesticide or application directly above to deal with like adulticide, adult mosquitos, if the applicator is following their requirements under FIFRA, we do not see the need for--we don't think that legally the Clean Water Act would require a permit because the pesticide is not a waste. It is a product that's being used in accordance with Federal requirements. Mr. Ose. My time's expired. The gentlelady from Michigan. Mrs. Miller. Thank you, Mr. Chairman. You were talking about States in regards to permits and that. But I am wondering how each of your agencies interacts with the various States on West Nile. It is great for us to sit here in Washington and talk about the West Nile virus. But it is really for the individuals right out into the neighborhoods to identify what is happening out there, and I have to show off a little bit for my State, I think, in Michigan. I mentioned to you that, you know, a couple of years ago, several years ago no one had ever heard of West Nile before. And I'll tell you, in our State it is a household word now. Everybody is well aware of the dangers of it. In fact, there's sort of a subtle paranoia, I think, that has set in in the psyche of many mothers watching their children and making sure that they are--and Dr. Fauci was mentioning some of the various therapies and that. But I think sort of the old therapies of just wearing long sleeves and long pants and trying to protect yourself, putting on your pesticides, insecticides I should say, and all these kinds of things probably work well. I guess my question is how you're working with the different States. I mentioned to you that we have this Web site, and if you've not had an opportunity to look at it you might want to do that. I don't know what the other States are doing. I can only speak for our own State. But of course we are all a society now that is so much more using the electronic format to access information. And this is a fantastic Web site. You can go on here and it tells you how to report a dead bird, a sick bird or a mammal, and then it actually gives you a bird identification page and the kinds of birds that might have the West Nile virus, the different kinds that you might--you're looking at a starling and you think it is a crow and all of these kinds of things, and then goes right into a site where the individual citizen would fill out their date of observation, when they observed this, what kind of thing they think they saw there and whether it was dead or they think it is sick and etc. If they want to have a lab come out and take a look at these sites. I just think it is a fantastic way to get information out into the public, and again, I am just wondering from the Federal Government's standard, from the agencies here, how are we doing? Are we doing similar kinds of things? Are your agencies doing similar kinds of things on the Web? Are you working with the States? Dr. Fauci. The direct involvement with the State and local public health officials is fundamentally the basis of how the Centers for Disease Control and Prevention interacts with the community. The National Institutes of Health, being fundamentally a basic and clinical research organization, is much more national and nonsegregated into States. So what we do is generically applicable to each of the States, and we fund grants and contracts. Clearly that are individuals that might be in State funded institutions, but it isn't directly related to a State function; whereas the CDC, as I am sure Dr. Ostroff will delineate for you, is much more connected to the State and local public health officials. Dr. Ostroff. Thanks, Dr. Fauci, and thank you, Congresswoman, for that question. Indeed, as was pointed out, one of our primary partners, if not our primary partner, are the State and local health departments. West Nile was first recognized in 1999; the following year we received an appropriation from Congress specifically to address the problem of West Nile virus in the United States. That allocation has gone up each year since, but has now plateaued. More than 50 percent of those resources have gone directly to the various State health departments to support specifically the activities that you mentioned, particularly monitoring, not only in humans, but also for dead birds, etc., to produce educational materials, to develop the Web site and to support the State public health laboratory in being able to do the diagnostic tests that are necessary to test those birds, to test humans who may conceivably have the disease. Our resources specifically to the State of Michigan, as the virus moved to the West from its original focus in New York, went up in concert. They reached a peak in 2002 and 2003 of about $800,000 per year, specifically to Michigan, to support the various activities that I just described. In addition, we keep in very close contact with the States. All of the States report in to our surveillance system, not only findings in humans, but finding in birds, finding in mosquitos, finding in humans and findings in horses. We produce updates that are published every week in terms of what's going on in the country, and we also hold weekly conference calls with all of our State partners where they share information with all of the other States to tell them what's going on within their jurisdictions. So we do have a fairly extensive program to support their activities. And last, if there are any unusual things going on in the State of Michigan or if they need specific technical support we actually send teams to work with them. Mrs. Miller. If I could followup on that just a bit, Doctor, as well, you mentioned in your remarks that you had a number of academic partners. And again, just from my own personal experience in Michigan we've actually put together a West Nile working group. Michigan State University is a critical element in that and I know the University of Michigan and some of the other universities as well. Could you expand a little bit on--some of our best research obviously is being done out in the universities, the campuses across our Nation. Are we bringing all of them into--utilizing them and advantaging ourselves of all of them as much as we need to? Dr. Ostroff. Well, actually in late 2002, which you pointed out was the worst year for Michigan, at the end of that year I actually went to the University of Michigan and gave medical grand rounds specifically on West Nile virus. We have a very close working relationship with the faculty of the Infectious Disease Division in the Department of Medicine, University of Michigan. We also have a very close working relationship with Michigan State University on veterinary issues, and you are indeed correct. There is superb capability to address West Nile. I do not know if any of the specific academic grants that we have related to West Nile go to the State of Michigan, but we can certainly find out. Dr. Fauci. You made the point that a substantial proportion of the research is done at the universities. As a matter of fact, the vast, vast majority of the research. If you look at the NIH funding, we only have about 10 percent of our research resources goes to our intramural program, which is fundamentally here in Bethesda, Maryland, and 85-plus percent of the money goes out to the universities. And we do have networks in coordination among them, particularly when we have interconnecting centers. Particularly with West Nile, for example, we have the World Reference Center for Research Resources to allow investigators from throughout the country and even the world to have access to resources to do the research. That's located at the University of Texas Medical Branch at Galveston. We also have collaborating emerging disease research centers, one in New York, one in Texas. So the local universities is really where we do our business with regard to research in this country. Mrs. Miller. Thank you. I think my time is up, Mr. Chairman. Mr. Ose. We'll have another round. The gentleman from Massachusetts. Mr. Tierney. Thank you, Mr. Chairman. Mr. Grumbles, I want to just focus in with you for a couple of seconds on the issue of the Clean Water Act if I could. I know back some time ago that the EPA filed an amicus brief in a case called Headwaters Inc. v. Talent Irrigation District in the Ninth Circuit. In that brief, the position of the EPA was that nothing in FIFRA or the Clean Water Act remotely suggests that compliance with FIFRA also means compliance with the CWA. The agency's brief highlights the distinct purposes of the two statutes and recognizes FIFRA's inability to adequately address the environmental effects. Here's specifically what the language in that brief said. ``In approving the registration of the pesticide, EPA concluded that the overall economic benefits of allowing the use of the product outweigh adverse environmental effects. EPA did not analyze, was not required to analyze, and could not feasibly have analyzed, whether, or under what conditions, the product could be discharged from a point source into particular public water bodies in compliance with the CWA. In approving the registration of Magnicide H, EPA did not warrant that a users compliance with the pesticide label instructions would satisfy all other Federal environmental laws. Indeed, EPA approves pesticides under FIFRA with the knowledge that pesticides containing pollutants may be discharged from point sources into navigable waters only pursuant to a properly issued CWA permit.'' What is the basis for EPA's change of position from that point? Mr. Grumbles. Mr. Chairman--Congressman, you made a strong reference in your opening statement to the need to reconcile the statutes and EPA fully agrees with that. It is about integrating the two statutes. On the specific points and the question you're asking, I would say a couple of things. One of them is, the footnote 1 in the July 11 memorandum, the interim guidance, that specifically addresses the brief that was filed in the case, the Talent case, and the basic point that's embodied in the EPA position and in the footnote in the July 11 guidance is that amicus brief was not saying--it wasn't, as you describe that, that it is that clear that the Clean Water Act needs to be added on top of FIFRA and will add value. Mr. Tierney. Excuse me. You don't think that language was clear? Mr. Grumbles. No. What I am saying is that the language that is clear is that there are not--just because the position of the agency is that there may be additional value added to a Clean Water Act program doesn't mean that a Clean Water Act permit should always be required in these cases. Specifically, our footnote says that EPA stated in the brief that compliance with FIFRA does not necessarily mean compliance with the Clean Water Act. However, the government's Talent brief did not address the question of how pesticide application is regulated under the Clean Water Act or the circumstances in which pesticides are pollutants under the Clean Water Act. And I think the key point, the key point, Congressman, is that in defining that phrase, that term ``pollutant,'' which is the trigger for Clean Water Act regulation, you need to look at the particular item involved. And with pesticides if they are fully meeting FIFRA, labeling and other relevant requirements under FIFRA, our view is that they're not a chemical waste or a biological material, the terms in the definition of pollutant in the Clean Water Act. Instead they're more of a useful product. So that's our current position. Mr. Tierney. And I have to tell you that is an ingenious stretch of language, and I mean I just think that you've gone way beyond the pale. Congress I would think would be the one to decide whether or not their statutes ought to be integrated or not. And I think that the department taking upon itself to change the position that was pretty clear, and I think concisely stated in your own brief, and then just decide at some point later that you're now going to say, well, we don't think you have to apply both of the Federal statutes that Congress put in place; we are going to say you pick and choose and then integrate, or however you want to phrase it, to say that one doesn't apply and the other does is troublesome to me. And on that it is troublesome. It is a change from your previous position without any apparent rationale for it and it is troublesome that you would take Congress's role upon yourself as an agency to start interpreting and choosing which to apply or not. The definition is there that this is a pollutant and I don't see how you're ever going to get around that. I think the courts have been pretty definitive on that also. But if you as an agency want to recommend to Congress some action so that they could reconcile those, I think that's an appropriate role for an agency. If you think that there's something there. But I think that having admitted in your brief that when you're doing a NPDES permit that you're not necessarily considering those facts that are important for a Clean Water Act compliance, you know, it gives a good example of why there are two statutes out there and not one. And what I'd be interested in hearing, if we are going to have another round, is if you claim that FIFRA is all you need, then how do we protect those things that the Clean Water Act is supposed to protect? Mr. Grumbles. Can I respond? Mr. Chairman, first of all, EPA's position is that both FIFRA and Clean Water Act have important roles to play. We embrace the notion that even in those situations where our legal analysis is that the pesticide that's being lawfully applied is not a waste and therefore is not a pollutant and a NPDES permit is not required, that doesn't mean that other Clean Water Act provisions and authorities aren't relevant. And we fully recognize that the States have the authority to use additional Clean Water Act provisions or State law to add to the situation if they choose to do so. Because I think the point is worth making that while the FIFRA label does have environmental safeguards, a State may choose to add additional provisions that are more site specific or tailored to that particular water body. But our legal analysis, Congressman, I don't view that it has changed. We have fleshed out with greater specificity the types of analyses and factors you use in parsing out the language. And the courts across the country certainly recognize--I mean, there is a role for the agency and there is most definitely a role for the Congress on adding further specificity or clarifying what these sometimes vague terms mean in the statute. Mr. Ose. I just want to followup on something here. Dr. Fauci and Dr. Ostroff, I am going to get to you. Don't worry. I am not ignoring you. You'll get your turn. Mr. Grumbles, if I understood you correctly, you answered ``no'' to the following question, and that was do public health mosquito larvacide and adulticide applications made in strict accordance with EPA registered labels constitute point source application of pollutants? And I believe you said no, is that correct? Mr. Grumbles. More specifically, I was saying that they do not constitute a pollutant. You know better than anyone. There are actually more than two, three tests as to whether or not a Clean Water Act permit is going to be required. One is, is it a discharge of a pollutant; the second one, from a point source; third, into navigable waters or waters of the United States is how it is further defined. What we are saying through our guidance and in our interpretation is that in that situation, if it is being lawfully applied in accordance with FIFRA and it is a direct application of a pesticide into waters of the United States, it is not a pollutant and it doesn't require a permit. That doesn't address the issue of the mechanism in which it is being applied, whether it is sprayed or aerially applied. The general counsel for the agency did issue in September of last year, an interpretive guidance that does address the question of point source that you're getting at in your question, and that guidance was also a direct response to the Forsgren case, which involved aerial application of the pesticide to control moth infestation in forests. And in the guidance of our general counsel, what we stated was, is that we interpret our regulations on silvacultural operations to be very narrow in terms of the types of point sources that are called point sources for silvacultural activities, and that other types of activities such as fire control are nonpoint sources. And so we have spoken pretty clearly on that point that the application is covered by our current regulations that say that type of silvacultural operation is not a point source. Mr. Ose. I think my question is whether it was a pollutant, and I think I hear you saying it is not. Mr. Grumbles. It is not a pollutant if it is being directly applied or directly over, that's the case. Mr. Ose. OK. One of the reasons this issue is of such interest to me, it is right at the intersection of public health, our environmental concerns, and science. You could see by the preponderance of witnesses on this panel exactly what our interest is. The questions that Mr. Tierney asked drove home the point from my perspective of the need for a rule as opposed to guidance because a rule will provide that safe harbor that the vector control districts and the like across the country can then utilize to define whether application of this particular pesticide or herbicide or whatever is a pollutant in this case. We have to figure out a way where when we are talking about public health issues of this nature that we understand the nature of the application of the chemical we are using, and I think it is reasonable to ask that at least within that very narrow scope, that we obtain a rule, properly crafted through the Administrative Procedures Act and what have you, that we obtain a rule that provides a safe harbor for folks out in the rest of the country. So the question I have is, will you issue a rule to that effect? Mr. Grumbles. The answer is perhaps. We are going through 480 comments on the interim guidance. We are taking those very serious. I mean, there are a lot of substantive important components to the guidance. They can shed light on our decision on whether to finalize the guidance and also when we finalize it, and most importantly from your perspective, whether or not to issue a rule. I would like to say that those who believe that a rule, a rulemaking process resulting in a rule, will create a safe harbor, may have false expectations. I think one of the reasons the Clean Water Act has been both a success and also been controversial at times is that citizens suit provisions-- whether we finalize our interim guidance, Mr. Chairman, or go through a lengthier process of an actual rule, our view is that citizen suits will still be brought. If Congress changed the statute then that becomes a more difficult question whether or not citizen suits will be brought. What we are focused in on is making sure that the agency's guidance, the policy we have is finalized, and we are taking very seriously your recommendations that we go forward with a rulemaking, but we frankly haven't reached that point yet, Mr. Chairman. Mr. Ose. If I understand the written testimony from the other witnesses in the aggregate, it is that you can generally project 6 to 8 months in advance whether or not you are going to have an outbreak of West Nile virus based on infestation, or whatever the word is, within a bird population or something, and the evidence indicates that next spring we are going to have a problem in California. The comments you have received on the guidance you have been working on for a year, and it is my further understanding that the courts give far greater deference to a rule issued by a Federal agency or department, however narrowly constructed, than they do to guidance. So I just want to come back to this, and that is that the vector control districts across the country in areas that are likely or projected to have outbreaks of this disease in the spring of 2005 could stand the assistance in a timely fashion from EPA with a narrowly constructed rule that provides a safe harbor for the application of these pesticides for public health purposes. And, I want to communicate that in no uncertain terms to you. I like clarity, and I am trying to be clear. Mr. Grumbles. And we appreciate that and receive it-- understand it very clearly. I think it is also important to keep in mind that States can--even if we do go through with a rule, States can still use their discretion to require a permit. Mr. Ose. All right. The gentlelady from Michigan. Mrs. Miller. Thank you, Mr. Chairman. I think I just have one other question, but I want to go to why there has been such a dramatic decline in the incidence that we are experiencing with the West Nile virus. I think it was Dr. Fauci who provided us--I thought this was sort of interesting--this article in the Sun: West Nile Both Flares and Fizzles. Just 5 years after its arrival, the West Nile virus has completed its east to west invasion of the United States and Canada; and, at the same time, the mosquito virus may be having a diminished impact on Maryland and other States where it has resided. I am also aware of an article, just in September here, from the Healthy Day News; and they describe the lower occurrences of the West Nile virus infections in the East and the Midwest. They said that this was due to higher levels of animal immunity, actually, to the disease. So perhaps you could talk a little bit about the adaptability of the disease, and, as like all viruses, I suppose, it begins to change its shape. Are we sort of in danger of seeing a different strain that is going to reappear here? Dr. Fauci. Well, I can begin to answer the question. I am sure that Dr. Ostroff also has some comments on that. In general, we don't know precisely why we have this waxing and waning. But if you look at it mechanistically it certainly is related, at least in part, to the building up of immunity not only in the intermediate hosts but also in humans themselves. When it first came to the United States in 1999, we would be considered what is called a naive population in the sense that there is virtually no immunity in the population. You get a country like Israel that has had this before us, that their level of ability to protect is considerably better because they have had experience. So one could project that over years, as we get more and more seasonal involvement, that the naivete will go down and there will be, in the population, people who have some degree of immunity. Obviously, as new children are born, they will come in and will also be naive, in a sense; and there may be the transient people that come back and forth. So you will always have a group of naive patients, naive individuals, but as you go further and further into what we call an endemic area, where it is there and it has been there, then you would unlikely see major blasts like we saw on the slide that Dr. Ostroff showed where we went from 62 cases to 32 to 100 and then 4,000 and then 9,000. It is unlikely that once you reach a stable baseline that is going to happen. We have similar experiences with other Flaviviruses. For example, St. Louis Encephalitis Virus, you don't hear much about that now, but it has the potential to do the same thing that West Nile did. So it really is related, at least in part, to the baseline immunity in the population of people as well as in the animal hosts. Dr. Ostroff. I would echo Dr. Fauci's comments. There are a couple of points that I think are salient. One of them was that, after West Nile first appeared in New York, particularly in the areas most affected, such as Queens, we actually did surveys the following year where we went out and caught live birds and tested them to see whether they had immunity against West Nile. In New York alone that immunity ranged from more than one in two birds that we caught, so 50 to 60 percent of the birds were immune. In some other areas that were not heavily impacted, it was only 1 or 2 percent. You need susceptible birds out there to amplify the virus in nature. If you don't have that susceptibility, the virus has a difficult time amplifying the following year. We believe that, as this wave has moved across the country, similar patterns have followed. So if you go into the Rocky Mountains this year in places like Colorado, you would find high levels of immunity in the bird population. Their immunity traps the virus from being able to amplify to levels that increase chances for exposure to an infected mosquito. However, the important thing is that birds don't live very long. So after a couple of years all of those immune birds, if the virus hasn't been widely circulated, go away, and you once again have a susceptible population of birds. As far as humans are concerned, we have done a number of surveys in various locations after West Nile has swept through. There has been no population that we have seen with relatively high levels of immunity, despite the fact that for every severe case of illness that occurs with West Nile there is somewhere between 100 to 150 other people that were infected but never got sick. So that if there were, let's say, 600 or so cases in Michigan in 2002, you can multiply that by a factor of 100 to 150 and see that there were probably 60,000, 80,0000, 100,000 individuals that were infected. That doesn't do enough to actually block subsequent transmission to humans. Other reasons that we may be seeing this waxing and waning include West Nile's very complicated ecology in this country. We know that have there have been more than 50 different species of mosquitos that have been identified as carrying this virus. Not all of them are as competent in being vectors to humans. In addition, there have been more than 250 different bird species that have been identified as being infected. So as you go from place to place around the country the predominant mosquitos that are responsible for transmission tend to be different, which causes the impact and the amount of disease from place to place would also be expected to also vary. The third thing that I think might be playing some role is what we are doing to reduce the impact of the disease; and whether it is public education or whether it is what the local mosquito control districts are doing, I would like to think that some of our best programs such as the programs in California, are also having some impact. Mrs. Miller. Thank you. Mr. Ose. The gentleman from Massachusetts. Mr. Tierney. Thank you. Mr. Grumbles, I just want to try to wrap up some things. I have really three things that are bothering me here, is your definition of pollutant, your attempt to reconcile two statutes that seem to me to be distinct in their purposes, and that--the so-called guidance itself, which I think you purport is not a rule and somehow didn't need notice and comment. So take it maybe the first order first. Can you explain to me your legal rationale for determining that what you have done in putting out this so-called guidance somehow doesn't meet the definition of a rule as it is put out in the Administrative Procedure Act as has been interpreted by the courts? Because I think I look at it quite differently. Mr. Grumbles. Our approach is that it is interpretative guidance, in essence, an interpretive rule. It is not a rulemaking. We didn't have to, Congressman, but we did seek notice and comment; and we have had---- Mr. Tierney. But after the fact. You put it into effect, and then you sought notice and comment, right? Mr. Grumbles. We put it into effect immediately and---- Mr. Tierney. Well, let me just read to you what the Administrative Procedure Act says. Basically defines a rule as the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret or prescribe law or policy. The courts in fact have held that definition is broad enough to include nearly every statement an agency can make. I am having a hard time figuring out how you somehow manage to think just because you don't call it a rule that you avoid that interpretation of the law. Mr. Grumbles. Well, our attorneys made it very clear that this was an appropriate, accepted practice through the Administrative Procedure Act to issue this interim guidance; and our plan, Congressman, is to take full analysis of the comments and then---- Mr. Tierney. Sorry to interrupt you. Because that is late. The whole purpose of the Administrative Procedure Act is that you have notice and comment before it goes into effect. And I don't care what kind of back-flips your attorneys are telling you are OK to take. I don't think there is any room for wiggle where it says, the whole or part of an agency's statement of general or particular applicability and future effect designed to implement, interpret or prescribe law or policy. The Court is clear. Just about any statement the Department makes comes under that. I would like you to take back to your lawyers and maybe go back to their first year of law school and go back to reading that. Because I think they are dead wrong on that. I think it is offensive to the whole act. I think that, you know, we all want to get the right answer on this, but we want to do it the right way. If there are Federal laws that are trying to protect our health and safety, you know, it is Congress that should be listening, as we are here today having hearings. I thank the chairman for having these. If something needs to be reconciled, we should do it. But that brings me to the second point. The Federal Insecticide, Fungicide, Rodenticide Act [FIFRA], deals with establishing, through a labeling, the general acceptability of that product, am I correct? Mr. Grumbles. Yes. Mr. Tierney. Now, that is fine. But how is EPA then going to determine with regard to the specific application or injection of that product into a particular local body of water if it doesn't take the Clean Water Act and do a NPDES permit? Aren't you abrogating your responsibility under the CWA, the Clean Water Act, and the NPDES requirements to just give out that first level of FIFRA and then say, hey, we are going to try to make them reconcile by having it apply to those particular circumstances without taking a look? Mr. Grumbles. Congressman, I don't think we are abrogating our responsibility. I think the intent is to integrate the statutes and to have them work together. Mr. Tierney. Well, let me ask you that. If you are integrating them and you think you are going to serve that purpose, then at the time you are going giving out the FIFRA thing are you then purporting to look at every local body of water to see whether or not it is going to be a pollutant in that body of water, whether or not it meets the clean water standard? Because I think that's the only way you can do just one of the two and serve the purposes of both. So how do you do that? If you rely just on FIFRA, how do you do that, what is required by the CWA? Mr. Grumbles. I think there are two aspects. One is, we don't just rely on FIFRA. There are Clean Water Act relevant factors and programs that play into this, just not the NPDES permitting program. Mr. Tierney. Why not? Mr. Grumbles. Because our best legal reading of the statute is that in two situations when an applicator is following all of the relevant requirements of FIFRA, which are extensive---- Mr. Tierney. They are not. You have already said yourself they may be extensive, but they are general. And they do not handle the specifics of a particular body of water. Right? Mr. Grumbles. Well, there is nothing in the Clean Water Act or in EPA policy that would prohibit or discourage other laws being used or States using clean water provisions or laws to address those site-specific factors. It doesn't always---- Mr. Tierney. But EPA has the responsibility, does it not, under the CWA to make these kinds of determinations to issue or not issue a NPDES, unless Congress tells you otherwise? Mr. Grumbles. We have a responsibility under the CWA which we take very seriously, and that is to implement it as it is written and to make good judgment as to where there are grey areas as to which licensing or permitting program applies. Mr. Tierney. You have two different statutes. Congress has told you two different things. On FIFRA, they are giving you directions on what to do, and on the NPDES, within the CWA, they have told you what to do. Tell me where it is that your agency then decides when it will apply one and not the other, because we are just going to make some theory up that they somehow can be reconciled, when you have already admitted to me that one does a very general overview on that and the other deals with specific bodies of waters and injections into them. Mr. Grumbles. The Clean Water Act is going to be 34 years old in a few weeks; and at this point in time, there are areas where courts, State, local, Federal agencies, citizens have questions about the jurisdictional scope. Mr. Tierney. When they have a question, then Congress will answer it, I suspect, not the agency and a reinterpretation, even from its own previous statements and legal briefs, where they made clear that FIFRA deals with one thing and that the NPDES deals with the other and that when they approve a pesticide under FIFRA they do it with the knowledge that pesticides containing pollutants may be discharged from point sources into navigable waters only pursuant to a properly issued CWA permit. That is your department's language. When you think that something has become unclear to you, even though it was clear as a bell apparently at one point here that you put in a legal brief, I would think that you would come back to Congress with a recommendation that all of a sudden things have gotten fuzzy for you. Maybe it is the new lawyers on your staff. Maybe we ought to have them in, Mr. Chairman, for a little conversation. Because I think it is somewhat unfair to put Mr.--you are not a lawyer, Mr. Grumbles? Mr. Grumbles. I am. Mr. Tierney. You are. Well, maybe it is fair to have you here then, and maybe we can go over your legal background. Mr. Ose. Let the record show that the witness answered in the negative, that it is fair. Mr. Tierney. Let me just say how is it that you are so crystal clear in one brief and then all of a sudden you decide that for Congress--you are going to take the role of Congress and decide now that we are just going to do one of those and that is going to cover everything. Mr. Grumbles. Congressman, in all fairness, I don't think things are crystal clear in this area. What I think is clear is the legal basis we have for articulating our view, the view that when a pesticide is being lawfully applied under FIFRA, which does include environmental and water quality related safeguards---- Mr. Tierney. In general. Mr. Grumbles [continuing]. In general, that it is not a waste. The best reading of the statute--and there is lawsuit after lawsuit, as you know, over how to interpret those words in the definition of pollutant. Mr. Tierney. But so far they have been interpreted to apply to both FIFRA and NPDES. Mr. Grumbles. Well, my understanding is no. The history of the agency is not to require a NPDES permit under the Clean Water Act for those situations. Mr. Tierney. But the interpretation of the courts is what you are talking about, and they have so far instructed that both are applicable? Mr. Grumbles. I would say just as many courts have not and have taken a very different view, the view that if it is being lawfully applied it is not a waste, it is a product. And if it is a product, then it is not a pollutant. We embraced the notion that Clean Water Act programs and factors should be taken into account precisely for that reason. When the agency issued the July 11 interim guidance, we also established a work group between the FIFRA folks and the clean water permitting folks specifically with the task of doing several case studies on pesticides, one of which would be a mosquitocide, to analyze the risk minimization and risk management structures under the two statutes and to see how they differ. But from a legal analysis, Congressman, our view, until Congress gives us clearer direction, is that the best reading of the statute, the one that we have had over the years, is that the pesticide is not a waste or a biological material, it is not a pollutant under the act when it is being applied fully in accordance with all relevant FIFRA requirements in those two situations of direct application above waters of the United States and also direct application to waters in the United States. Mr. Tierney. Thank you. Mr. Ose. Dr. Ostroff, you had that map--1999, 2000, 2001, 2002, and 2003. Can we get that back up on the easel, please? I have asked for this map to be put back up because it very graphically depicts the concerns that all three of us up here have expressed. If you look in the upper left-hand corner, you see 1999; upper right-hand corner 2000, 2001, 2002, and 2003. If you look closely, you will notice that every State represented up here on the map is affected by this issue; and what I hear us saying in no uncertain terms is that the development and issuance of a rule, however crafted or scoped, will provide a great deal of certainty to this process. Mr. Tierney I think makes a very good point, that the lack of enforceability, if you will, under guidance leaves a lot of doors open. I have made that point not nearly as eloquently. I think Ms. Miller did, too, more eloquently than I did. But my point is that, absent the certainty of a rule that has gone through due process and what have you, we are going to be stuck in this circle. Now every one of us up here recognizes that the guidance came out for a very real purpose. That was there was a threat to public health, and we needed to provide some guidance, and that served its purpose. But we are now to the next step, and we need that rulemaking, at least as it relates to the public health issue that we are all confronted with as represented by that map. Now, Dr. Fauci, Dr. Ostroff, educate us a little bit. When we talk about these mosquitos, the period of time during which the larvae can be laid and mature to traveling mosquitos, that is a highly technical term, mosquitos that can fly, what period of time are we dealing with? Is it 48 hours, 72 hours? Do either of you know? Dr. Ostroff. It probably varies by the mosquito, but it is a relatively brief period of time. And, obviously, it also depends on the weather conditions. So it is not a straightforward answer, but you are not talking months, you are certainly talking about days for the mosquitos to go through their lifecycles. Mr. Ose. So, under optimal conditions, it might be as little as how many days? Dr. Ostroff. I believe as little as 1 or 2 days. Mr. Ose. From the time the larvae are laid to the time where they are in the air? I have people shaking their heads. Dr. Ostroff. They are the experts from the Mosquito Control Association. Dr. Weisbuch. Our experience in Arizona is that---- Mr. Ose. Would you identify yourself? Dr. Weisbuch. I am Dr. Jonathan Weisbuch from the State of Arizona, Maricopa County. Our experience is that there are multiple--I will be presenting a little more of this at the next panel. Our experience has been that there are multiple different mosquito types that are potential vectors for this disease. The most common mosquito that we see, and I think it is true across the country, are the Aedes vexans and other flood water mosquitos. They are usually not carriers of the disease, and they are very short-lived. Their larvae cycle may be 2 to 3 days, depending on the temperature that is extant in the community. Of course, in Arizona it is very high, and so the days of larvae period is very short. When the mosquito becomes an adult, the flood water mosquitos last maybe a week or even less; one feeding cycle maybe the whole time. However, the most serious vector, which is the one that we see and which I think is more common in the West of this country than it is in the East, that is the Culex tarsalis mosquito and the Culex quinquefasciatus mosquito. These are longer-lived mosquitos. I think the former can live up to 3 weeks or more depending on the ambient conditions, and that means that they can lay eggs several times in their cycle, since once they can bite an appropriate mammal or possibly reptile then they lay eggs; and then another 4 or 5 days later they will do the same thing. So depending on what the ecology is in the area in which we are talking--and this is the one of the questions that I am going to raise in my discussion--you have a different manifestation of the frequency of infected mosquitos, the probability that an infected mosquito will in fact bite another acceptable host and the probability that mosquito will live to bite again. Infection with West Nile virus is dependent on many different variables. And the question that I think we need to ask is, how do these variables interrelate? How does temperature, how does rainfall, how does the lifecycle of the mosquito, depending on its ambient conditions, affect the infection rate of other host animals and especially human beings? Because it is highly variable. Again, we will talk more about that later. But I think it is a critical question in knowing--and for us in public health to know--what is the epidemic going to look like, given a rainy spring, a dry spring, a hot spring, a cold spring? These kinds of questions, if we knew the probabilistic relationship between the multiple factors, would give us an opportunity to make some predictions about how bad the epidemic might be, where we have to focus our efforts, is it larvaciding, is it adultaciding, and so on. Mr. Ose. I thank you, Doctor, for that clarification. We actually do have a number of questions along that path that we will ask you in the second panel, so I appreciate the clarification. The reason I asked about the minimum-maximum life spans has to do with, from a public health perspective, how quickly must you act? And Dr. Ostroff and Dr. Fauci, any guidance? I mean, if it breaks out--I mean, you guys have to start--you have to be rolling almost before the first mosquito takes air. Dr. Ostroff. Well, Congressman, what I would say is, and I think the folks behind me that do mosquito control for a living would say, doing integrated pest management is most important. You should be taking steps to control mosquito populations during the winter months when you have an opportunity to do so. It is habitat management. It is larval control. It is many different things. And the earlier you start in the cycle the more likelihood you have of success. Once the mosquito transmission season gets up and rolling, all of us I think would be in agreement that where we get into trouble is when many of those things haven't been done earlier, and then people get into an epidemic situation, and have to resort to tools which we know probably aren't the most effective ways to protect public health, such as using adulticides. What we would like to see is more mosquito control districts using comprehensive integrated pest management so that many of these steps are potentially averted in the midst of a crisis. Mr. Ose. Dr. Fauci, anything to add? Dr. Fauci. I have nothing to add. Dr. Ostroff said that very well. It is comprehensive, and it is year-round. Mr. Ose. Dr. Ostroff, this is my last question in this round. Do I recall in your testimony, you said 2.6 percent of the population in certain portions of New York City are infected with West Nile virus? Dr. Ostroff. Not infected--had at one point become infected. We have done several surveys after outbreaks have swept through communities to see what proportion of the population actually became infected when West Nile was circulating. We did this in New York. We also did this in Louisiana after a relatively intense outbreak in Louisiana in 2002. And in each of those situations, by doing random surveys of the population and taking blood samples, we were able to determine that between 2 and 3 percent of the population had actually become infected and were now immune. Mr. Ose. And some percentage of that 2 to 3 percent actually gets the worst result? Dr. Ostroff. Correct. We know from surveys that have been done that if you take all comers with West Nile infection, the vast majority of them won't develop any disease at all. Mr. Ose. The statistic was 80 percent? Dr. Ostroff. More than that. More than 90 percent. So only 1 out of every 150 individuals that become infected will develop the most severe forms of the disease. There are another 5 to 10 percent or so who will develop what we refer to as West Nile fever, which is not a nice disease, but it is not a very severe disease that would put you in the hospital. Also, by looking at blood donors who were infected at the time that they donated the blood, we have been able to determine that 20 percent of those individuals will subsequently become sick, most of them with West Nile fever, and another 1 to 2 percent will develop the more severe forms. Mr. Ose. So what is the level at which smallpox or the flu or something like that becomes a pandemic? Is it at the level that you are talking about of 1 in 150, or 2 or 3 percent? Dr. Ostroff. It is different for every disease. But I would say that the West Nile virus in this country for the last several years has clearly been epidemic as it has moved from place to place to place. When it will convert itself to endemicity so that we won't be in its epidemic waves in the way that we have been seeing is hard to say. We think that it is clearly still in its epidemic phase. If I was to look at that map and say what is likely to happen in 2005, one would think that it would continue to, in your State of California, move to the north, in areas that haven't yet been very heavily impacted. What will happen in subsequent years is still difficult to say. Because, as was pointed out, it depends on a lot of factors. What we do know is that it hasn't gone away anywhere. So in every State where this virus has shown up we have seen it at some level year after year after year. So this is a problem we are going to have to continue to deal with into the future. Mr. Ose. Dr. Fauci, do you have anything to add? Dr. Fauci. No. I agree. And if you do comparisons, for example, of diseases like influenza at each given year, 10 to 20 percent of the population will get infected with influenza, and a fraction of them will have very serious disease. The numbers that we were speaking about yesterday with the issues that arose yesterday, the 36,000 people a year who die in this country from influenza and about 200,000 get hospitalized, but if you are taking about 10 to 20 percent of 288 million people, that is a lot of people that get infected, and a relatively small number will get seriously ill. Mr. Ose. Thank you. The gentlelady from Michigan. The gentleman from Massachusetts. Mr. Tierney. I have a question that may be best reserved for the next panel, but it seems to me that probably two objections to looking to get both permits would be cost and time. So setting cost aside for a second, if time for permitting is a problem, isn't there some way of anticipating where this is going to occur and having some sort of anticipatory process where people get their plans approved and go through the NPDES process? So in the event that there is a need for these pesticides that they are all set and ready to go, as opposed to waiting until they are inflicted with a situation and then going through? So I guess the relevant question would be, how much time does the permitting process actually take? And maybe Mr. Grumbles can help us with that. And then for the other witnesses included, maybe whether or not it is possible to anticipate a need and get the permitting done ahead of time. Mr. Grumbles. Congressman, on the question of the timing, NPDES permitting can--you know, there are basic variations. There are individual permits which can take years to issue. It is a process. Mr. Tierney. Clearly that won't help then. Mr. Grumbles. No. There are general permits. I think the general permit, it can be a much more expedited, administratively convenient approach. But I think it is a question well put to the regulated community, the applicators in terms of their time constraints or the necessity to go through that additional permitting process and experiences in California or Oregon or Washington where there are clean water permitting authorities being used. So I think timing--it just varies. It ranges. But certainly it can be viewed as a cumbersome process, particularly from the applicators' perspective if they feel that they have done everything under the FIFRA program. Just so that you don't think that EPA spends all of its time looking at Clean Water Act jurisdiction, we would like to just highlight some of the things we are doing in terms of developing new products and also revising pesticide labeling. Could I just defer to Adam Sharp? Mr. Ose. Given the constraints of time, Mr. Tierney is likely to have more questions. Mr. Sharp, could you submit those for the record? Mr. Sharp. Sure. Thank you. Mr. Tierney. That would be fine with me. Thank you for your offer on that, and we will certainly take a look at them. [The information referred to follows:] [GRAPHIC] [TIFF OMITTED] T8485.045 Mr. Tierney. I only say this because I am thinking that, you know, if we should decide and if it is determined that the NPDES process is important--that will have to be something that is ironed out or whatever--the next step is how do you make that process expedited so that it gets the purpose done and doesn't drag people through all of this cost and time and then serves that purpose. Clearly, the inference from the people, I think we are going to hear on the next panel, is that it is not that way now. That has created some of the problems. But, Dr. Fauci and Dr. Ostroff, I don't know if you have anything that you want to weigh in on this issue or just leave it for the next panel? Dr. Fauci. Leave it. Dr. Ostroff. My only comment would be that we don't have as many tools as we would necessarily like to be able to deal with this problem. I mean, this is a battle against this disease and against this virus and against the mosquitos that transmit it; and anything that we can do to facilitate being able to do what is necessary to deal with this battle would certainly be welcome. I don't want any of our public health partners at the State and local level to be going into this battle with one hand tied behind their back. Mr. Tierney. At some point, we ought to weigh what is the danger of pollutants in the water versus the danger of not getting this resolved fast enough. But that is a larger issue. Mr. Ose. I actually think that is Mr. Grumbles' and Mr. Sharp's central dilemma, is how to work through that. Mr. Tierney. Exactly. Thank you all very much. Mr. Ose. I have one other question here, if I may; and this is unique. In my neighborhood, one of the local municipal entities is proposing to create a settling basin. This is in Sacramento. We get very hot summers, and we have rain. They want to create a wetlands. If you were living in that immediate area, would you be concerned or not concerned about the creation of this wetlands? Dr. Fauci. Dr. Fauci. Environmentally, a lot of people love wetlands. But if you have standing water in a State that has the risk that California has now with West Nile, I would be concerned about providing the macro and micro environment for some rather efficient proliferation of mosquitos. So I would be concerned. Mr. Ose. Dr. Ostroff. Dr. Ostroff. Well, without knowing any of the specifics, it is really difficult to answer that question. Mr. Ose. I will be happy to give them to you. Dr. Ostroff. As somebody that if there is one mosquito in the neighborhood it manages to find me, I would definitely have concerns about the standing water. Mr. Ose. Thank you. I want to thank this panel for their testimony and their patience. We will probably have additional questions for submittal to you, which we will do in writing. We would appreciate a timely response so that we can make them part of the record. Again, your testimony has been very illuminating, and we appreciate your participation. We are going to take a 5-minute recess here while the next panel comes up and joins us. [Recess.] Mr. Ose. OK, we are back. Just for safety's sake we are going to go ahead and swear everybody in again. So if you would all please rise. [Witnesses sworn.] Mr. Ose. Let the record show the witnesses all answered in the affirmative. Our second panel, previously introduced, is composed of the following individuals: Mr. John Pape, chief epidemiologist for the Colorado Department of Public Health and Environment; Dr. Jonathan Weisbuch, director of public health from Maricopa County, AZ; Mr. Joe Conlon, technical advisor to the American Mosquito Control Association; Mr. David Brown, who is the Chair of the integrated pest management portion of the Mosquito and Vector Control Association of California; Ms. Wendy Station, who is the founder of Encephalitis Global; and Dr. Marm Kilpatrick, who is a senior research scientist for the Consortium for Conservation Medicine at the Wildlife Trust. Collectively, welcome. Thank you all for coming. You have seen how we handled the first panel. We have received your testimony or your statements in writing, and they have been entered into the record. Each of you in turn will be recognized for 5 minutes for the purpose of summarizing your written statement. We usually go from left to right. Today, we are going to go from right to left on second panel. So, Dr. Kilpatrick, you are first. Welcome. You are recognized for 5 minutes. STATEMENTS OF DR. MARM KILPATRICK, SENIOR RESEARCH SCIENTIST, THE CONSORTIUM FOR CONSERVATION MEDICINE AT WILDLIFE TRUST; WENDY STATION, FOUNDER, ENCEPHALITIS GLOBAL; DAVID BROWN, CHAIR, INTEGRATED PEST MANAGEMENT, MOSQUITO AND VECTOR CONTROL ASSOCIATION OF CALIFORNIA; JOE CONLON, TECHNICAL ADVISOR, AMERICAN MOSQUITO CONTROL ASSOCIATION; DR. JONATHAN WEISBUCH, DIRECTOR OF PUBLIC HEALTH, MARICOPA COUNTY, AZ; AND JOHN PAPE, CHIEF EPIDEMIOLOGIST, COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT Dr. Kilpatrick. Mr. Chairman and members of the subcommittee, thank you for giving me this opportunity to discuss these important issues. My name is Marm Kilpatrick, and I am a senior research scientist with the Consortium for Conservation Medicine. The Consortium is a collaboration between Wildlife Trust, a conservation NGO, the USGS's National Wildlife Health Center, and three universities--Harvard, Tufts and Johns Hopkins. The Consortium is a leader in the field of conservation medicine, which explores the links between human health, wildlife health and ecological health. I am a disease ecologist working on West Nile virus through a project funded with Federal and private foundation grants. My testimony focuses on four major points: First, the efficient allocation of resources to control West Nile virus during mosquito season; second, the prediction of disease hot spots at least a year ahead of time; third, the sharing of data between scientists and government; and, finally, the spread of mosquito-borne pathogens over oceans. First, concerning resource allocation, our research group has developed a risk assessment or framework that allows for the comparison of a West Nile virus epidemic between locations at different spatial scales. This risk measure is easy to describe and understand, which should facilitate its use by resource managers in a range of settings. Our risk measure is based or incorporates information on human density, mosquito abundance, and prevalence data collected by surveillance efforts and published information on mosquito feeding behavior and vector competence. In short, it is a prediction or an estimation of the impending number of human West Nile virus infections based on the current state of mosquito populations. It offers important advantages over resource allocation strategies that do not include unbiased information on the intensity of disease between areas. Its use could improve the efficiency of control efforts during mosquito season by allocating limited financial resources to the areas that need it most. Second, if we can predict West Nile virus hot spots at least a year ahead of time, we can implement effective but slower-acting strategies such as education outreach and the development of integrated mosquito control plans. However, hot spot prediction requires an understanding of what determines spatial variation and disease intensity. Unfortunately, our understanding of the basic ecology of West Nile virus is limited. As a result, additional funding for research is urgently needed to determine, among other things, the relative importance of mosquito abundances, the composition and previous exposure of the bird community, and climatic effects on disease transmission. Third, our understanding of West Nile virus would be greatly facilitated by the increased sharing of data between health departments and scientists working on this disease. The mosquito abundance and infection prevalence data collected by county and State health departments is extremely valuable for understanding spatial and tempo of variation in disease intensity, but, unfortunately, is rarely available to planners and scientists. Although there are some privacy and property value concerns that impede data sharing, it should be possible to work with local health departments to address these issues. One strategy that may be effective is to aggregate the data to a level that maintains its usefulness for research and planning while also addressing the privacy and property value concerns. If surveillance data can be made available, the creation of an open access data base to archive the data would greatly facilitate research and understanding. Fourth, and finally, recent work by our group suggests that the introduction of mosquito-borne diseases from other continents to North America and the spread of West Nile virus to Hawaii is likely to occur through the accidental transport of mosquitos on airplanes. Research suggests that the most promising and politically feasible strategy to reduce the number of live mosquitos on airplanes is the use of a residual insecticide coating on the inside surface of airplane cargo holds, where over 80 percent of mosquitos are usually found. This strategy achieves significant reductions in mosquitos and avoids the politically difficult issue of using insecticides in airplane passenger cabins. However, implementing this strategy requires compliance by airlines, the air transport industry, and the military, which is unlikely to occur without government intervention. Nonetheless, urgent action is necessary to prevent the introduction of new pathogens. In particular, the introduction of West Nile virus to Hawaii could have strong negative consequences for Hawaii's public health, tourism, and a long list of critically endangered birds. In summary, I believe tools are available to improve the efficiency of our control efforts, but additional data sharing, research funding, and proactive regulatory action are necessary to meet the challenges of combating West Nile virus. Once again, thank you for your time and the opportunity to discuss these issues. Mr. Ose. Thank you, Dr. Kilpatrick. I do want to compliment you. You were very specific on four approaches, and that is exactly the kind of feedback we look for up here: specific, pointed, boom. So thank you. [The prepared statement of Dr. Kilpatrick follows:] [GRAPHIC] [TIFF OMITTED] T8485.046 [GRAPHIC] [TIFF OMITTED] T8485.047 [GRAPHIC] [TIFF OMITTED] T8485.048 [GRAPHIC] [TIFF OMITTED] T8485.049 [GRAPHIC] [TIFF OMITTED] T8485.050 Mr. Ose. Ms. Station, thank you for joining us today. Ms. Station is the founder of Encephalitis Global and is here to talk not only about those who might have died from West Nile virus or its associated diseases but in part also about those who survive it and the consequences thereof. You are recognized for 5 minutes. Ms. Station. Thank you, Mr. Chairman. Good morning to yourself and the subcommittee members and guests here today. As you know from my testimony, I am an encephalitis survivor. I am here today to proudly speak on behalf of encephalitis survivors, caregivers and their loved ones. Encephalitis impacts the whole family. Today, I speak in one voice for all of these families, asking you to please recognize encephalitis. Hear more, learn more, understand what it means. Encephalitis is inflammation inside your brain. Encephalitis has changed my life. I cannot clearly verbalize. I cannot clearly and verbally express the ideas in my head. I cannot think of the right words to make conversation. I am neurologically disabled, and I struggle to express my thoughts and my ideas. Yesterday, on arrival here in Washington, DC, my good spouse and I--that is, my husband and I--we went for a walk, then stopped into an informal restaurant for dinner. We got chatting with a young couple who had a new baby. They sat at the table beside us. They asked why we were here. When I told them why I was invited to this hearing, the young mother said to me, ``tell them, explain it clearly. I am so worried for my husband, for myself, and now for our young son. You tell them that something must be done so that we don't have to be so scared.'' I am here today to speak for my friends and for families like the one I met just yesterday. I thank you very much for the honor of your recognizing my Web site, Encephalitis Global. I work daily to help society be aware and to help families and friends cope with this disabling disease and thank you, sincerely, for this opportunity to do so. Mr. Ose. Thank you, Ms. Station. We are pleased you are able to join us. [The prepared statement of Ms. Station follows:] [GRAPHIC] [TIFF OMITTED] T8485.051 [GRAPHIC] [TIFF OMITTED] T8485.052 [GRAPHIC] [TIFF OMITTED] T8485.053 [GRAPHIC] [TIFF OMITTED] T8485.054 [GRAPHIC] [TIFF OMITTED] T8485.055 [GRAPHIC] [TIFF OMITTED] T8485.056 [GRAPHIC] [TIFF OMITTED] T8485.057 [GRAPHIC] [TIFF OMITTED] T8485.058 [GRAPHIC] [TIFF OMITTED] T8485.059 Mr. Ose. Our next witness is Mr. David Brown, who is the Chair of the integrated pest management efforts at the California Mosquito and Vector Control Association. Sir, welcome to our subcommittee. Appreciate your written statement. It has been read and entered into the record. You are welcome to summarize in 5 minutes. Mr. Brown. Thank you, sir. Good morning, Mr. Chairman and Congressman Tierney. My name is David Brown. I am a member of the Mosquito and Vector Control Association of California, an association comprised of 57 public health agencies responsible for the control of mosquitoes and other vectors in California. I also co-chair the Association's Integrated Pest Management Committee; and, Congressman, I am also the manager of the Sacramento Yolo Mosquito and Vector Control District, the area where you earlier referred to, the detention basin being developed. Mr. Ose. That is a coincidence, I am sure. Mr. Brown. Since 1999, as West Nile virus has steadily moved west, we have seen its arrival here in California to where, as of October 1, 2004, West Nile virus has been detected in 57 of the 58 counties of California, with over 654 humans infected and 18 deaths. There have also been 419 equine cases, with 177 of the horses dying from the infection or requiring euthanization. Most of the human infections have been located in the southern part of the State, but as the virus becomes more established we can anticipate Northern California facing serious issues next year as well, and I believe that was discussed and confirmed from the earlier panel as well. California has what could be characterized as the most comprehensive mosquito control programs in the United States, fully utilizing integrated pest management in our control efforts. California's unique blend, however, of wetlands, agriculture and dense urban populations create a public health challenge when addressing mosquito populations. However, since we have seen West Nile virus move into California, we have significantly increased surveillance for mosquitoes, cooperating with the California Department of Health Services in a dead bird surveillance program. We dramatically increased control responses in areas where the disease has been detected, and we have increased education to citizens on how they can prevent the disease themselves. We do have concerns about sustaining and maintaining these efforts, as has already been outlined from the previous panel and in my written testimony. Specifically, issues of funding regarding maintaining our mosquito control efforts as well as the need for clarity of regulations between the Clean Water Act and FIFRA. We are hopeful that we can address some of these issues today. I want to thank you for the opportunity to provide this testimony, and I will be happy to address questions later. Mr. Ose. Thank you, Mr. Brown. I appreciate your participation. [The prepared statement of Mr. Brown follows:] [GRAPHIC] [TIFF OMITTED] T8485.060 [GRAPHIC] [TIFF OMITTED] T8485.061 [GRAPHIC] [TIFF OMITTED] T8485.062 Mr. Ose. Our next witness is Mr. Joe Conlon, who is the technical advisor to the American Mosquito Control Association. Mr. Conlon, I have actually waded through your testimony, and I have lots of questions. I am hoping you can summarize and clarify. You are recognized for 5 minutes. Mr. Conlon. Very well, sir. Good morning. My name is Joseph Conlon. I am an entomologist serving as technical advisor for the American Mosquito Control Association, a nonprofit organization dedicated to enhancing public health through the suppression of mosquito vectors; and I welcome this opportunity to provide a mosquito control perspective to the deliberations of this committee. The introduction and spread of West Nile virus in the United States has reawakened an appreciation of mosquitos as vectors of disease. I use the term reawakened advisedly, for mosquito-borne diseases were once quite prevalent in the United States and indeed played a major part in shaping our Nation's destiny. These diseases no longer claim victims in the United States as a matter of course, largely due to the exemplary effort of organized mosquito control agencies in conjunction with an enlightened and effective public health infrastructure. Best mosquito management practices, when exercised within an integrated framework of surveillance, prevention and control, have demonstrated their effectiveness in combating West Nile virus when employed as a phased response challenge. The integrated mosquito management methods currently employed by organized control districts in the control of West Nile virus and endorsed by both the CDC and EPA are comprehensive and specifically tailored to safely counter each stage of the mosquito lifecycle. Larval control through water management source reduction, where compatible with other land management uses, is the lynch pin of this strategy, as is use of the environmentally friendly EPA registered larvacides currently available. When source elimination or larval control measures are clearly inadequate or in the case of imminent disease, both the EPA and CDC have emphasized in a published joint statement the need for considered application of adulticides by certified applicators trained in the special handling characteristics of these products. The extremely small droplet aerosols utilized in adult mosquito control are designed to impact primarily on adult mosquitos that are in flight at the time of application. Degradation of these small droplets is extremely rapid, leaving little or no residue in the target area at ground level. These special considerations are major factors that favor the use of very low application rates for these products, generally less than 4 grams active ingredient per acre, and are instrumental in minimizing adverse impacts. Since its inception, the Environmental Protection Agency has regulated mosquito control through the enforcement of standards instituted by FIFRA. This legislation mandated documentation of extensive testing of public health insecticides according to EPA guidelines prior to their registration and use. These data requirements are among the most stringent in the Federal Government and are met through research by established scientists in Federal, State and private institutions. This process costs a registrant several million dollars per product but ensures that the public health insecticides available for mosquito control do not represent health or environmental risks when used as directed. Indeed, the five or six adulticides currently available are the selected survivors of literally hundreds of products developed for these uses over the years. The dosages at which these products are legally dispensed are at least 100fold and often several thousandfold less than the point at which public health and environmental safety merit consideration. In point of fact, literature posted on the Web sites of the EPA Office of Pesticide Programs, CDC, American Association of Pesticide Safety Educators and National Pesticide Telecommunications Network emphasizes that proper use of mosquitocides by established mosquito control agencies does not put the general public or the environment at unreasonable risk from runoff, leaching or drift when used according to label specifications. Even with these safeguards, organized mosquito control agencies often go to extraordinary lengths to accommodate individuals who, for varying reasons, prefer their property not be sprayed with approved public health insecticides. When surveys indicate the need for adult sprays, they are approved, planned and conducted with special regard to the concerns of chemically sensitive persons. Personal notification of chemically sensitive individuals, the spray times, in addition to using global positioning systems and global information systems technology to reduce the likelihood of drift over unauthorized areas are but a few of the means utilized to ensure mosquito control serves the entire public health spectrum. The AMCA fully endorses the Clean Water Act's intent of reducing pollutant load in the Nation's clean water while allowing productive use of that resource. However, the AMCA considers NPDES permits attendant to this legislation to be both redundant and unnecessary for the application of public health insecticides specifically registered by EPA under FIFRA. Furthermore, the excessive fiscal burdens that NPDES permits entail through compliance measures and threat of civil lawsuits will ultimately divert scarce mosquito control resources away from the primary mission of protecting human health while not contributing tangibly to the critical goal of environmental protection. In January 2003, the American Mosquito Control Association proposed a rulemaking by EPA to exempt mosquito larvacides duly registered under FIFRA for water application from NPDES permit requirement. A clear articulation by EPA of the exemption of FIFRA registered mosquito larvacides and adulticides from these permitting requirements through a rulemaking would both tangibly validate the registration process while obviating further civil litigation. The EPA currently has this issue under active review, but at some point definitive action by the agency is needed or the citizen suits attendant to CWA will continue to proliferate. West Nile virus has now accounted for almost 16,000 cases, 622 fatalities, and 48,000 cases of meningoencaphalitis. Those statistics are but a pale shadow of the human experience of this devastating disease. The increase in worldwide tourism and trade virtually guarantees further challenges from other exotic mosquito-borne diseases such as Japanese encephalitis and Rift Valley Fever in the future. Should these emerging diseases settle into the American public health landscape, particularly an as unintended consequence of otherwise laudatory environmental policy initiatives, we will have only ourselves to blame, for we have the means to control these diseases within our grasp. A robust interagency cooperation and design, resourcing and implementation of sustainable mosquito-borne disease programs are cornerstones of this national effort. In conjunction with judicious application of federally registered and NPDES-exempt public health mosquito insecticides when warranted our shared goals of both the health populous and environment can thus be attained--our citizens and our Nation's wildlife deserve no less. Again, thank you for the opportunity to testify, and I would be most happy to answer any questions. [The prepared statement of Mr. Conlon follows:] [GRAPHIC] [TIFF OMITTED] T8485.063 [GRAPHIC] [TIFF OMITTED] T8485.064 [GRAPHIC] [TIFF OMITTED] T8485.065 [GRAPHIC] [TIFF OMITTED] T8485.066 [GRAPHIC] [TIFF OMITTED] T8485.067 [GRAPHIC] [TIFF OMITTED] T8485.068 [GRAPHIC] [TIFF OMITTED] T8485.069 [GRAPHIC] [TIFF OMITTED] T8485.070 [GRAPHIC] [TIFF OMITTED] T8485.071 [GRAPHIC] [TIFF OMITTED] T8485.072 [GRAPHIC] [TIFF OMITTED] T8485.073 [GRAPHIC] [TIFF OMITTED] T8485.074 Mr. Ose. Our next witness is the chief health officer for Maricopa County, AZ, somebody right there in the heart of the struggle on this, Dr. Jonathan Weisbuch. Welcome to our subcommittee, and you are recognized for 5 minutes. Thank you. You need to push it so the green light is on. There you go. Dr. Weisbuch. Thank you very much for inviting me to testify before your committee, Mr. Chairman. I am Dr. Jonathan Weisbuch from the Maricopa County Department of Public Health and the chief health officer in that county. Our struggle in 2004 with the West Nile virus I think all of you are familiar with. I am going to discuss four points. First of all, what we knew prior to the epidemic, what we did, and then what we have learned and the questions that we have. Controlling mosquitos in the greater metropolitan Phoenix area possess unique challenges. Maricopa County is over 9,000 square miles, larger than several States. Its population, 3.5 million, exceeds that of 20 States. While much of Arizona is desert, Maricopa County has built an artificial oasis, the perfect harbor for mosquitos. We have green lawns, golf fairways, lakes, wetlands, irrigation canals, storm sewers, an urban heat island, and the largest number of private home swimming pools in the Nation. We estimate it at the level of 500,000. During our long hot summer, many of those backyard swimming pools go unused, go unmanaged, and are available for mosquito larva. And we can show this, if we have a copy of the first slide. It's just a map of the area. This is the central part. I guess this doesn't show on there, the central part of Maricopa County, only part of it, about 2,000 square miles, all of which are filled with dense area of human beings; and then we have horses, we have chickens, we have birds, we have a variety of other things, including harborage for mosquitoes. In late 2002 we estimated that 2003 would be the time in which West Nile would arrive in Maricopa County, but it did not. We then knew that 2004 would be our time. Mosquito disease usually impacts Arizona during our rainy season in late July, and then peaking in August and waning in September as diurnal temperatures decline and mosquitoes become inactive. We began larvaciding using the management technique that has been described earlier. We began larvaciding our breeding sites in late March 2004 and surveillance of both mosquitoes and animal cases, including human cases, in April. We had a communication package ready to go after our first case in order to inform the public of the situation. But unfortunately, nature in our case did not cooperate. A blood donor was identified on April 24, long before our normal season. The first human case was reported in mid-May. The epidemic was in full swing and by the end of May we had over 60 cases. Our media message was very simple. We stressed prevention: Clean up your back yard, clean up your neighborhood, report mosquitoes to environmental services, report stagnant swimming pools, use repellent, long sleeves, and stay indoors after dark. As a result the media ran several stories. Complaints increased to the hundreds a day to our environmental control program. We were fortunate that the message did get out; Ninety-eight percent of our residents were aware of the West Nile virus and how to prevent disease; 71 percent had done something; but only 30 percent had ever used repellant. By the end of June we had 150 cases. July was our hot month. Temperatures were over 100 every day. Mosquito trap counts were increased, as did the viral infection rate of mosquitoes. Chickens, horses, and dead birds showed West Nile infection, and 100 new cases of human disease were added to the total, giving us 250 cases by July 31. Half of those cases were encephalitis and meningitis. We had two deaths. We can show the second slide which is a picture of what the epidemic looked like in the different colors; you have it in front of you. The different colors indicate encephalitis, meningitis fever, and what have you. And the cases reported from blood sampling. We began expanding our larvaciding to the hundreds of green pools that have been reported. Over the course of this last summer we did over 1,000, 1,500 green pools, to larvacide them. We doubled our fogging with anvil 2.2 and then doubled it again before the end of July as we added fogging devices to our fleet. In late July, with the epidemic raging in Maricopa County, our conference call with CDC discussed the possibility of aerial spraying for the entire 2,000 square miles that I showed earlier. That was a big step we chose not to take. In August we increased our mosquito traps. We expanded our fogging where the traps showed vector mosquitoes and viruses to be prevalent. We expanded ground fogging tenfold so that by the end of the season we had fogged well over a million acres. That's about 10 times the size of the city of Philadelphia. West Nile-positive mosquito pools and vector mosquitoes began to decline. Mosquito complaints dropped. Human cases also began to go down. Was this a cause and effect with our spraying and the decline? I cannot say. There are several other slides that we could show. We can show the case, and the next case would be the--have you got it up there? This is, again, the reported cases slightly different from the cases by the time of onset. But you can see this line over here at the end of the slide which indicates the number of acres that we larvacided. And you can see here in the middle of June we've increased or doubled the number of acres, then we doubled it again toward the middle of July, and then we exploded it as our number of foggers became available to us. The next slide shows something similar to that which is really the same case reports, but if you can see the small line, that's the proportion of mosquitoes that we trapped which were infected with the virus. And it is the virus in the mosquitoes that causes the disease and you can see that in the outset of our epidemic it was high. It began to decline as we began to do the other efforts of adulticiding. Map No. 5 indicates, again the total number of--it's hard to see on the slide here, but you have it in front of you. There are 347 cases shown on this slide, the total number that we've had through September, and it cuts across the entire county of Maricopa where every area was infected. The last slide, of course, is just a summary of the cases that we've discussed. Deaths, however, continue to increase. We've had six in Maricopa county, one extra one in the State of Arizona. That final case actually was a blood recipient from blood that had been tested and where they had missed the virus so that we would--we were unaware of the fact that the individual had been given tainted blood until we went back and checked. The 2004 epidemic has taught us a great deal, the interrelationships between the multiple factors that were discussed in the previous panel--the bird migration, over- winter cycles, mosquito infection rates, vertical transmission to larva, seasonal variations in temperature and rainfall, and the particular nature of our own built environment all have an impact and interrelate in the explosion of our epidemic this year. We think that mosquito traps are probably our best surveillance tool because they give us rapid information about what the vectors are and whether they're infected. And we also recognize that physicians do not always recognize West Nile viruses, either in their cases or in those who have succumbed to the disease. Close surveillance of disease and infectious disease encephalitis and deaths is very important by our epidemiological staff. Stagnant swimming pools are probably our most significant breeding sites. They are extremely difficult to manage. We know little about the impact of pesticides on people, and that ignorance has undermined our ability to assure citizens that the risks of pesticides is worth the benefit of killing adult mosquitoes. Mr. Ose. Doctor, could you summarize here? Dr. Weisbuch. I'm going to summarize. We have a number of questions you have before you. But let me just say in conclusion, our experience with West Nile virus exposed underlying deficiencies in the public health infrastructure that can only be rectified with adequate funding for State and local public health systems and a national investment in the applied research that was described earlier in the earlier panel. Congress and States should determine how to provide health departments with sufficient fundings to support public health infrastructure so that this and other kinds of health problems can be managed. A small percentage of the $1.5 trillion spent in the national medical system could be allocated to strengthen the public health infrastructure and assure that the health of the public and communities would be preserved in the event of unexpected biological events. Absent the necessary resources, the health of this Nation will continue to be at risk. And I thank you very much, Mr. Chairman, for the few extra minutes, and I appreciate the opportunity to speak before you today. Mr. Ose. Thank you, Doctor. [The prepared statement of Dr. Weisbuch follows:] [GRAPHIC] [TIFF OMITTED] T8485.075 [GRAPHIC] [TIFF OMITTED] T8485.076 [GRAPHIC] [TIFF OMITTED] T8485.077 [GRAPHIC] [TIFF OMITTED] T8485.078 [GRAPHIC] [TIFF OMITTED] T8485.079 [GRAPHIC] [TIFF OMITTED] T8485.080 [GRAPHIC] [TIFF OMITTED] T8485.081 [GRAPHIC] [TIFF OMITTED] T8485.082 [GRAPHIC] [TIFF OMITTED] T8485.083 [GRAPHIC] [TIFF OMITTED] T8485.084 [GRAPHIC] [TIFF OMITTED] T8485.085 [GRAPHIC] [TIFF OMITTED] T8485.086 Mr. Ose. Our final witness on the second panel is John Pape who is an epidemiologist for the Colorado Department of Public Health and Environment. He too has been at the center of significant efforts dealing with West Nile virus. Sir, welcome to our panel. We have received your statement. It has been entered into the record. I have read it and I'd be happy to recognize you for 5 minutes for the purpose of a summary. Mr. Pape. Thank you, Chairman. On behalf of the Colorado Department of Public Health and Environment, our local health partners, and the citizens of Colorado, I'd like to thank the committee for this opportunity to share THE Colorado experience with West Nile virus. As is well known, since its introduction into New York City in 1999, this virus has marched rapidly across the country resulting in large outbreaks in each of the last 3 years. Thus our experience in Colorado is not unique. Many States have felt the bite of West Nile virus. I would also like to take this opportunity to thank our partners at the Centers for Disease Control and Prevention whose technical and financial support were absolutely crucial to our response to West Nile virus. Without the CDC investment in laboratory and public health infrastructure, Colorado would not have been prepared to respond when West Nile entered the State in 2002. Additionally, as has been discussed earlier, the collaborative research between CDC, State and local health agencies, academia, and private industry have been critical to our understanding and response to this emerging infection. By the time West Nile virus reached Colorado in August 2002, relatively few human cases had been reported in Eastern States and there was considerable uncertainty as to what West Nile virus would do in the Western United States. In preparation, Colorado enhanced its comprehensive surveillance system, upgraded laboratory capacity and launched Fight the Bite- Colorado, a multifaceted public education campaign focused on personal protection to avoid mosquito bites. In consideration of time, I will not reiterate the details of the 2003 epidemic in Colorado that resulted in 2,947 cases and 63 deaths; actually 64, as one of our patients died just this week. This information IS provided in written testimony. However, it is important to note that neighboring States in Nebraska, South Dakota, Wyoming, were hit just as hard as Colorado in 2003 and that has been discussed in these hearings. Other States have experienced West Nile epidemics, including Arizona and California this year. So this is a national issue. Colorado was the first State to make a conscientious effort to investigate all patients who were diagnosed with any illness from West Nile virus, not just the more severe illnesses of meningitis or encephalitis. This effort has advanced our knowledge on the clinical spectrum of West Nile infection which is still not completely defined. Personally I know several people who were infected last year. For most, fortunately, the illness lasted a couple of weeks, followed by a full recovery. However, the middle-aged daughter of a longtime friend and public health colleague was not so fortunate. She was infected, developed encephalitis and paralysis in one leg. A year later she is still severely affected, and subsequent testing has demonstrated permanent brain damage that has left her unable to work or care for her daughter. For some people, infection with this virus is a life-altering event, and that is why prevention is so critical in our response to West Nile virus. Colorado's prevention efforts revolved around three areas: surveillance to identify high areas of risk of virus activity; public education on personal prevention measures; and encouraging local community-based mosquito control. All three components are necessary. We do need to improve our public prevention messages to encourage citizens to take personal precautions. Many people heard these recommendations but did not take actions to protect themselves. In the semi-arid climate of Colorado, nuisance mosquitoes are not a widespread problem like other more mosquito-prone areas of the country, and thus mosquito infrastructure is not as well developed or extensive, if it exists at all, in many areas of the State. Based on health department recommendations, many jurisdictions expanded or implemented mosquito controls. Others did not. Reasons for not implementing control varied, but generally held to four themes: tight budgets with competing community needs; uncertainty as to the impact of West Nile virus and the benefit of mosquito control; the stance that if people took personal precautions such as repellent use, mosquito control was unnecessary; and vocal opposition to mosquito control from some members of the community with a potential of lawsuits. In particular, adult mosquito control--that is, spraying-- is controversial. And although a survey found the majority of Coloradans would support spraying in the face of an epidemic, there are many constituencies out there that will oppose such action under any circumstance. Congress could take several steps to assist State and local agencies in addressing mosquito-borne disease problems and removing barriers to local control efforts. Foremost, as has been discussed at these hearings, would be resolving the contradictory Federal laws that could potentially result in a district complying with pesticide regulations under FIFRA, but then being sued under provisions of the Clean Water Act. And we've gone through that--this committee's gone through that. Pesticide regulation should be incorporated under one law, a law that encourages development of new, effective, environmentally friendly mosquito control products and methods. Second, the Mosquito Abatement for Safety and Health Act, which was passed and signed into law 2 years ago, has never been appropriated. Funding the MASH Act would provide communities with startup funds from a matching grant to initiate mosquito control that would then be maintained by local resources. And, finally, the funding provided from CDC for West Nile surveillance prevention and research was critical to our preparedness and response to the epidemic. Continued funding support of research and basic public health infrastructure at national, State, and local levels is imperative. As we've seen with the outbreaks of West Nile virus, with monkey pox, with the continuing threat of bioterrorism attack, a strong public health system remains vital to the health and security of U.S. citizens. Thank you. Mr. Ose. Thank you, Mr. Pape. I appreciate your testimony. [The prepared statement of Mr. Pape follows:] [GRAPHIC] [TIFF OMITTED] T8485.087 [GRAPHIC] [TIFF OMITTED] T8485.088 [GRAPHIC] [TIFF OMITTED] T8485.089 [GRAPHIC] [TIFF OMITTED] T8485.090 [GRAPHIC] [TIFF OMITTED] T8485.091 [GRAPHIC] [TIFF OMITTED] T8485.092 [GRAPHIC] [TIFF OMITTED] T8485.093 Mr. Ose. OK. We went from right to left with our public statements. We're going to go from east to west on our questions. Mr. Tierney, you're recognized. Mr. Tierney. Thank you, Mr. Chairman. And I'm going to be brief because I have to leave. And I mean no ill intent toward the panel here. I thank you for your testimony, which has been read with some interest. Dr. Kilpatrick, let me just ask a couple of quick questions. You talked about the need for better evaluating where resources for preventing and combating West Nile viruses are most needed. Can you explain why it's important to look at information that goes beyond just the number of positive human West Nile virus cases in a given area? Dr. Kilpatrick. Yes. Thank you for the opportunity to address that. I think as several of the speakers have suggested, putting resources in place before human infections take place is the only way to kind of prevent them. And so if there can be a framework that can predict the risk of a human epidemic, then you can put the resources in those places to try to stop things from happening ahead of time. Mr. Tierney. You made some comments about the data base needed to be improved. Can you add some specifics on that and tell us how more comprehensive data would be helpful to your efforts and other researchers' efforts? Dr. Kilpatrick. Yes, definitely. So in my view, the two most important pieces of information in terms of assessing the risk of a West Nile virus epidemic are the mosquito abundances and the infection rates of those mosquitoes. And currently, unfortunately, those two pieces of information are not part of Arbonet, which is the CDC's data base. And my experience has been those are not part of that because of issues I discussed having to do with county health departments not wanting to provide those data for either privacy or property value issues. But if those two pieces of information could be brought together in a data base that would be available for planning either on a statewide or a countrywide level, that would immensely help us in understanding and predicting where epidemics would occur. Mr. Tierney. Is it the general consensus from our individuals? Mr. Pape. Mr. Pape. Well, we actually use that data in Colorado, what Dr. Kilpatrick was talking about, both the mosquito populations, the make-up of mosquitoes--because some species are better at transmitting this than others--and mosquito infection rates. And we calculate those. I'm not sure of the value at a national level because this is such a focal disease. If you look at the information in my written statement, 46 percent of our cases last year occurred in a very small area of the State. It was a very focused area. And you would find some cities that were hit very hard, and 20 miles down the road another town had much lower activity due to environmental factors and other things in play. So we really look at that data at the State level but focus more on the local picture, because it does provide you with evidence of how bad the activity is this year, or how much human risk may be present. Mr. Tierney. So would you argue against putting that information on CDC's data base? Mr. Pape. I don't think there's any problem with it from our end. We have that data available and could easily transmit it to CDC with the rest of the data we provide through Arbonet. For us it would not be an issue. Mr. Tierney. You don't think you'd get any resistance with respect to the property value issue or things of that nature? Mr. Pape. No, not at this point. Mr. Tierney. Dr. Weisbuch, you wanted to say something? Dr. Weisbuch. Yes. We have accumulated the same information. We've augmented it with meteorologic data in terms of the temperatures and the amount of the rainfall in different sections of the communities so that we can combine all of the several factors, hopefully, in some kind of a mathematical model, which I think is what's being done. And I would look forward to using that and sharing our data with either CDC or with the Harvard-Tufts-BU group that's doing this work. I asked in the beginning who can project for me from what we already know in April when we had our first couple of cases who can tell me how big this is going to be? We didn't have that capability. And I think that others in the future would like to have it so that we would know where to focus our efforts, where to do our larviciding, where to place our traps. I think putting the large number of mosquito traps out early in the scene is critical so that you know which mosquitoes are out there, because some of them are very good transmitters, as I mentioned earlier in the hearing, and others--and then knowing in each of those mosquitoes what the prevalence of infection by virus is critical. Then you can focus your larviciding. You can focus your ground fogging, and you don't have to go to the more general fogging that is so difficult for the population, or at least members of the population, to accept. I mean, we've had as many arguments with the citizenry on our ground fogging as we've had about the disease itself. And I think that's something that needs to be addressed in this epidemic as well. Mr. Tierney. Thank you. I yield to the chairman. Mr. Ose. Will the gentleman yield? Doctor Kilpatrick has in his testimony a formula for calculating the risk of a human epidemic, and I'm curious whether the other witnesses have seen that formula. Have any of you seen the formula he laid out? Dr. Kilpatrick. It's just in the progress of being published right now, so I would guess that most people probably have not. Mr. Ose. All right. I'm trying to get to the model that Dr. Weisbuch was talking about, so---- Mr. Tierney. I yield back and thank the witnesses for the testimony. Mr. Ose. I thank the gentleman. Mr. Pape, on page 3 of your testimony, you make some interesting observations. I want to step through them. You state that opposition to mosquito control, with the potential of lawsuits from segments of the community, was one of the reasons certain Colorado localities did not implement mosquito control in 2003. And it's your contention that many local officials felt that this particular dynamic put them in a no- win situation. How did Colorado resolve this matter? Mr. Pape. Well, again, mosquito control in Colorado, as I think most of the country, is really a local decision item. It's locally funded and the citizens who pay through tax for the benefit of mosquito control receive that benefit. At several of our meetings, both with meetings we had with Colorado County Commissioners Inc., with our vector mosquito control associations, this issue of adulticide spraying comes up, and it's a very controversial issue. There's a lot of things that play into it. But clearly, in many communities, the feeling was that if they went ahead with it, went ahead with spraying in the face of opposition from some of these constituencies, that they would be opening up their community to a potential lawsuit. And so they would be putting out money to do the control, and then they would have to put out additional money to fight the lawsuit, from taking action that they felt was going to benefit the health of the people. It basically has been resolved by communities deciding was that risk worth it and voting whether they would enact or not enact mosquito control. One of the things I think is interesting is that in many communities the decision was made in the winter months, during January February when we were doing all our planning, doing all our discussions, that we were not going to do mosquito control. And yet, come mid-August when the community was faced with a couple hundred cases and the fifth person had died, suddenly there was a big public outcry to do something. And of course, by this time it's too late to gear up any type of effective measures. And I think that lesson was learned by many of the communities because a lot of those that opted out of doing any control last year, this year opted to do some. Mr. Ose. I mean, we had a long conversation with Mr. Grumbles about--from the EPA about the certainty provided under a regulation as opposed to a lack of enforceability under guidance. Would EPA issuance of a rule properly vetted under the Administrative Procedures Act and Congressional Review Act and all that, would the issuance of that rule be helpful or hurtful from your perspective in the field in treating this problem? Mr. Pape. It clearly would be helpful because any barrier that we can remove from a local community to take a preventative measure or to take some action would be helpful and move things along. This was discussed, this problem with the Clean Water Act and the requirement for an NDPES permit, at some length with a variety of our mosquito control agencies and communities. And certainly it was a concern. Mr. Ose. Dr. Weisbuch, down in Maricopa County, same question. Dr. Weisbuch. Yes. We didn't have that same kind of concern. For some reason the--I think Arizona has a unique situation, and that is that the counties have the full responsibility, granted from the State Department of Environmental Protection, to carry out the vector control services that county feels is necessary. During this last summer, some counties actually chose not to do any spraying of any kind. Maricopa, of course, has chosen to do limited spraying for several years. And this year we chose to do broad spraying. We did, however, have to gain support from our supervisors from the Maricopa County Board of Supervisors, who are our policymaking board, and without that support we would never have been able to spray. Four out of the five were in strong support of using an adulticide in order to cut back on this epidemic when we had over 300 cases in the middle of August. One of the supervisors, however, was strongly opposed to using adulticiding, and I think next year we may have more political pressure and certainly more pressure from the community itself against spraying. And I think we'll probably have to make a much more complex argument of the value for spraying. And that argument will have to include the cost of a death, the cost of illness, the cost of injury, as described earlier, all of which must play into the model for making a risk assessment: Is it valuable to spray or not? But I would emphasize Mr. Pape's point, that early intervention with larvacides, identifying the pools, identifying the breeding sites, identifying places where the mosquito lives over the winter, are all extremely important; and that's something which we've been doing, but we realize that the swimming pools themselves are clear areas that we have to address and we haven't in the past. Mr. Ose. Dr. Kilpatrick, in terms of the discussion we had with Mr. Grumbles as it relates to the issuance of a narrowly crafted rule focusing on public health, do you think the certainty that would come from that would be helpful or not helpful in these issues? Dr. Kilpatrick. I guess I would suggest that due to the time scale in which these problems present themselves, additional regulatory hurdles certainly are going to slow down efforts to try to reduce the problem when it happens. So I would think that certainty would in fact, as suggested by the other panel witnesses, help our efforts in combating this problem. Mr. Ose. Mr. Brown, Mr. Conlon, you guys have in the field--I mean, your membership and what have you deals with this. What's your feedback on this same question? Mr. Conlon. From a nationwide perspective there aren't any mosquito abatement districts that I'm aware of nationwide that are awash in money. They're all operating pretty much at the margins. Anything we can do to free up resources for them to do the preventive nature of their work is something we should pursue. Mosquito abatement districts outside the 9th Circuit are looking at this quite closely, because they can see this becoming writ large, and then they're going to be fighting rear-guard actions against that ad infinitum. And I think it's the statement that's being made of federally registered insecticides being de facto pollutants that's really got them scared, because this drives an emotive response from antipesticide activists that's going to keep mosquito abatement districts in a defensive role, and it's going to divert resources from where they really should be used. Mr. Ose. Well, I think the diversion of resources is an important point because the vector control district has X amount of money. They can either spend it to address the problem or they can spend it to defend themselves legally. You can't spend it for both. Now Mr. Brown, in Sacramento or central valley California, if I read my history correctly--and I guarantee you I've studied it well--that particular portion of the country at one time, 150 years ago, was a wetland. So you're kind of like at ground zero on this stuff. Mr. Brown. Yes, sir. And in fact as you well know, California has undertaken great lengths to try to restore much of the wetlands in our central valley which creates a potentially serious issue as West Nile virus moves its way up through the State into northern California. To underscore a little bit what Mr. Conlon mentioned, we're very concerned about the vague rulings right now coming out of EPA relative to the NPDES permitting process. I can tell you that the State of California has clearly stated that it is nothing more than a memo and therefore does not require any deference. We believe that the next step, minus any congressional action taken, would be for U.S. EPA to perform a rulemaking, as has been previously suggested. Mr. Ose. If I understand correctly, you have from the Attorney General a statement that guidance is nonbinding and--I mean, it's gone to that level. Mr. Brown. That's correct. Mr. Ose. It's gone to that degree of activity. So the issuance of a rule may very well solve the 9th Circuit problem. Mr. Brown. Correct. Mr. Ose. All right. Before I leave that point, you're from Sacramento. Mr. Brown. Yes, sir. Mr. Ose. If you lived across from a site where someone was going to build a settlement basin, would you be happy or unhappy, given the consequence that might arise? I'm going to keep asking until you answer yes or no, so you might as well just give up now. Mr. Brown. Well I've never been one to give up. So, in my capacity as the director of the district in Sacramento, I would go to great lengths to ensure that proper integrated pest management programs were in place to alleviate my concerns of mosquitoes being developed at that site. If I did not have that opportunity to do that, or if I had regulations put in place that prevented me from doing that, I can tell you I would be very unhappy. Mr. Ose. Now, you did talk about best management practices in your statement at length. And you also talked about the severe fiscal constraints that you operate under in the State of California for funding. Does the Sacramento Yolo vector district have adequate resources today to deal with the challenges it faces? Mr. Brown. Currently we believe that our district does. Understanding that, as what was mentioned in the previous panel, this is a disease that is within a naive population, so we aren't completely confident that we'll be able to reduce the mosquito population below levels that will result in transmission to humans. However, with the data that we've accumulated so far, we feel confident that we can reduce the numbers of mosquitoes so that it won't be as serious as in other parts of the country. Mr. Ose. One of the things California does is, it very comprehensively addresses environmental questions far beyond what perhaps happens in other States. One of those issues that we deal with is the preservation of wetlands for sound policy reasons. Do you see any correlation between a focus on preservation of wetlands, a successful preservation thereof, and the potential for a rise in the level of West Nile virus incidents? Mr. Brown. The short answer is, yes, I do. However, I don't think it has to be. I think that given the science that we know today, that we can restore many of our wetland values and yet reduce the numbers of mosquitoes that may come from those sites. Unfortunately, as is often the case and as you mentioned previously, 150 years ago California was a--certainly the central valley was a broad wetland, if you will. And for many reasons, mosquito control being one of them, a lot of them were drained. We have since recognized that the values of wetlands suggest that we should restore many of those wetland habitats. However, knowing why we conducted some of the draining that we did in the past, I think we can introduce the principles that would reduce mosquito populations, yet still enhance and restore many of the wetlands that we've lost. Mr. Ose. Your point being that it's one thing to build them. It's another thing to keep them in proper functioning order. Mr. Brown. Correct. Correct. The Chairman. Now, Ms. Station, in your experience how do-- I just want to be able to share this with my neighbors and constituents, of course--how do survivors of West Nile virus feel about some of the regulatory challenges and protests against the use of ground foggers or aerosol sprays? Ms. Station. They're very dismayed. Once you've been touched or had encephalitis touch you, touch someone in your family--they're frustrated with this no more spraying that's going on everywhere and all the fuss that's going on. So much of society and so much of the media is talking, as we're talking today, about what will we do in the future? Well, what can we do to fix this? So little attention has been paid to the people who've already been touched. I'm hoping that everyone here will include my Web site in references on their own Web sites so that the hundreds of people that are now coping with this debilitating disease can turn to someone for help. Mr. Ose. Well, now, Dr. Fauci and Dr. Ostroff, earlier in their written statements, clearly indicated that there's no curative medical treatment. I mean once you have it, you have it. That's the way it is. Even though they're working on some vaccines that would prevent a person from catching it. I guess my question would be perhaps directed to Dr. Weisbuch, the incidence of which people contract the disease and don't develop the really serious symptoms, what is that incidence? And then conversely, what is the incidence within the naive population that people do contract the disease and develop the very serious symptoms? Dr. Weisbuch. That's a complicated question because I think it varies or has varied across the country as I've looked at some the data. In the Maricopa County experience this year, we had 347 identified cases, laboratory confirmed, of illness. Approximately half of those only had fever with no residual whatsoever. We're following up on all of them to determine over the next 6 to 9 months to a year whether or not any other sequelae occur. But the other hundred and whatever, 50 or 60 individuals who suffered either a meningitis attack or an encephalitis attack, or both, that group obviously has the highest potential for long-term sequelae. We don't know at the present time what proportion of that group will, in fact, have residual 6 months, 9 months, a year from now. We're going to be following those. We do know that six of those individuals or actually seven have died as a result of the disease. And we also know that there are about a half a dozen or maybe a dozen who are still in intensive care units with all of the various ramifications of paralysis, coma, loss of sensitivity, inability to breathe normally, and so on. And we're expecting that some of that group will also succumb to the illness. One of the most interesting things that we've found in reviewing our six death certificates is that at least two of these individuals succumbed from what the physician called a respiratory paralysis. But when x-rayed, and in one case autopsied, there was no real evidence of a pneumonia. And so it appears that the virus is infecting the central aspect of respiration in the pons of the brain, where the individual is just dying from a respiratory disease as a result of their not moving their diaphragm, sort of like what polio used to do 50 years ago. These kinds of things need further evaluation and I think further research. We don't know the overall impact, long-term impact of this illness. It's only been a what, a 5-year problem. And I think that's--I think maybe Dr. Pape has other-- -- Mr. Pape. I would agree with that. We took an effort in 2003 to look at the full clinical spectrum of illness. If you look at data from earlier years from other States, they primarily were reporting meningitis and encephalitis, which was what the national guidelines recommended at that point. We tried to look at the full spectrum which is one of the reasons we had a large number of cases. Eighty percent of our cases were the West Nile fever. And what we found is there's not a, you know, nice even break where you have fever and then you break, now you have meningitis. It's a full spectrum from people who are ill a couple of days with fever, to some people who had prolonged fever--our average duration of people who had West Nile fever, the milder illness, was 23 days. That's they were sick, they had fever, they had aches, they had all these other symptoms, and it took them 2 or 3 weeks to get their strength back to be able to go back to work or function. As you get into, as Dr. Weisbuch talked about, the more severe manifestations, we actually had our 64th patient die this week, who has been in the ICU with respiratory paralysis since last August. And essentially this is identical pathologically to what we used to see with the polio epidemics in the fifties. It's a poliomyelitis that affects various nerves. And depending on which nerves the virus destroys, depends on whether your respiratory system get paralyzed; is it your arm, is it a leg, is it some cognitive function because of damage to those areas of the brain? And so there is really a wide spectrum of illness. We've actually got a couple of papers that we're working on that will be out shortly, scientific papers looking at exactly that question: What are the long-term ramifications, what are some of the clinical manifestations with this infection? Mr. Ose. You're not making a very good case for this settling basin across the street from my house. Mr. Pape. Well, if you were to ask me that question about the settlement basin, I would say I wouldn't have opposition to it, provided part of their plan is, as Dave Brown pointed out, was that they're going to do some kind of mosquito control. And, in fact, we have seen those problems, I think other States have experienced it, where for instance we have a wetlands. One city I know in particular has a federally protected wetlands on the border of their city that they will not allow--are not allowed to do any control on. And so they have a buffer zone of control between the city and that wetlands area, because they get a lot of mosquitoes coming off of the wetland since it's protected as natural, and we don't want to get rid of the fish food or the bat food or things like that. I won't argue the validity of that point because I tend to be fairly environmentally sensitive myself. But I think there are situations where, in the case of that catch basin, it would be beneficial to be able to go and put some larvacide into it. Mr. Ose. All right. I want to come back to this particular question. I want to ask Ms. Station something, and that is that you indicated in your statement that a lot of people don't take vector-borne diseases very seriously because historically there's been a very low number of deaths and the large portion of those people who get infected, they have a relatively minor sickness. Now, how do we get the message out that there's a certain group of people where the impact of that sickness is severe? How do we get that out? I mean, you're talking to some folks who are on the front lines here. Help me help you, so to speak. How do I do that? Ms. Station. How do we do it? Any way possible, sir. I spend 12 hours a day on the computer. I started my Web site in the year 2000. I write to newspapers. I've got a newspaper article that was published here in, oh, just within the past week that was--I just got in the mail yesterday. I go on talk shows. I was on a talk show radio, I believe it was in Minnesota last year. I pound the pavement. And that seems to be the only way to get the message out. I see here, Ohio State University says in a recent study it was found people who were hospitalized last year with encephalitis, with West Nile encephalitis, they have reported problems 1 year after their illness including headaches, concentration problems, fatigue, movement disorders. Let's see, New York State, they did a study saying nearly two-thirds of severely infected patients still suffer physical and mental impairments 12 months after falling ill. So I would do anything I could. Mr. Ose. Excuse me. All right. Like Pavlov's dog, we all learn what the bell means. What we've got is a 15-minute vote that's just been called on the floor, followed by a 5-minute vote. So we're going to have to move quickly here. Mr. Brown, I want to come back to this issue on this catch basin. It is admittedly across the street from my house, but my neighbors and constituents have a concern about it. Now, this area is within the 9th Circuit, and if I understand correctly, under best management practices, a treatment with either a larvacide or an adulticide would be part of an integrated pest management system. But in California that would require an NPDES permit for application thereof. Am I correct on that? Mr. Brown. At least for the larvacide. It's one of the concerns about the vagueness of the ruling that we have currently in California. There is an NPDES permit for the application of larvicides in California. It is silent to date on an application of an adulticide. It has raised concerns, as has already been mentioned, about the potential of litigation for the use of an adulticide in and around that area you refer to. And could you give me the address of that area, by the way? Mr. Ose. Yes. Del Paso Regional Park at the very east end of the city. But it is also 9th Circuit case law that an NPDES permit will be required for the application of a larvacide. Mr. Brown. For a larvacide. Yes, sir. Mr. Ose. Right. OK. Dr. Weisbuch. Does that include biological larva sites? I mean, we use fish and we use a particular bacterium, Bacillus thuringiensis, I think. Mr. Ose. I believe it's restricted to the---- Dr. Weisbuch. To the oils. Mr. Ose. To the organophosphate classification. Mr. Brown. It is for the application of any registered pesticide. So the larvacide you're referring to, Bacillus thuringiensis, is a registered larvacide and would therefore require an NPDES permit as defined under the 9th Circuit. Dr. Weisbuch. I'm glad we don't have that in Arizona. Mr. Ose. And absent an NPDES permit, you can't apply the larvacide. Mr. Brown. Without fear of litigation. Mr. Ose. OK. Now, I have a significant number of additional questions here for each of you in turn. But we're not going to be able to get to them verbally here. As I indicated to the first panel, we will send those questions to you in writing. We would appreciate a timely response. I believe the record stays open for 10 days for Members and what have you who have been in attendance, in part or not, to submit additional questions. Those will be forwarded to you. I do want to thank you all for taking the time to come and testify. This is one of those interesting, as I said earlier, interesting intersections between public health, the environment, and science that gets very little play because it's highly technical and it requires some thought. I would urge you to stay on your message. I mean, stay at this. The MASH Act by Senator Gregg of New Hampshire-- eventually it will get funded. Unfortunately, it may be after 600-odd people have died and untold thousands have been infected. But stay on this. And California in particular, this is an issue I think of significant concern because of what the likely consequence of next spring will bring. Mr. Conlon, Mr. Brown, what you do across the country makes a difference. Dr. Weisbuch, Mr. Pape, what you do in Arizona and in Colorado is appreciated. Ms. Station, Dr. Kilpatrick, we thank you for your suggestions and your input. We'll send you the questions. This panel is excused and this hearing is adjourned. 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