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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

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

KATHERINE HARRIS, Florida

MICHAEL C. BURGESS, Texas

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

BETTY MCCOLLUM, Minnesota

———

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

CHRISTOPHER SHAYS, Connecticut

JOHN M. MCHUGH, New York

CHRIS CANNON, Utah

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

PATRICK J. TIBERI, Ohio

JOHN F. TIERNEY, Massachusetts

TOM LANTOS, California

PAUL E. KANJORSKI, Pennsylvania

DENNIS J. KUCINICH, Ohio

CHRIS VAN HOLLEN, Maryland

JIM COOPER, Tennessee

EX OFFICIO

TOM DAVIS, Virginia HENRY A. WAXMAN, California

BARBARA F. KAHLOW, Staff Director

LAUREN JACOBS, Clerk

KRISTA BOYD, Minority Counsel

(III)

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

(1)

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

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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

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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:]

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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

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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.

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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

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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:]

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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

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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:]

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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:]

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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.

56

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

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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

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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

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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 compliVerDate 11-MAY-2000 15:03 Mar 03, 2005 Jkt 000000 PO 00000 Frm 00063 Fmt 6633 Sfmt 6633 D:\DOCS\98485.TXT HGOVREF1 PsN: HGOVREF1
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ance 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 whethVerDate 11-MAY-2000 15:03 Mar 03, 2005 Jkt 000000 PO 00000 Frm 00064 Fmt 6633 Sfmt 6633 D:\DOCS\98485.TXT HGOVREF1 PsN: HGOVREF1
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er 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?

62

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.

63

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

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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.

65

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——

66

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

67

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

68

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

69

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

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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?

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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

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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:]

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74

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.

75

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; secVerDate 11-MAY-2000 15:03 Mar 03, 2005 Jkt 000000 PO 00000 Frm 00079 Fmt 6633 Sfmt 6633 D:\DOCS\98485.TXT HGOVREF1 PsN: HGOVREF1
76

ond, 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

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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:]

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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:]

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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:]

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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.

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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

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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:]

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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 fortuVerDate 11-MAY-2000 15:03 Mar 03, 2005 Jkt 000000 PO 00000 Frm 00116 Fmt 6633 Sfmt 6633 D:\DOCS\98485.TXT HGOVREF1 PsN: HGOVREF1
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nate 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.

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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:]

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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

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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

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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:]

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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

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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 segVerDate 11-MAY-2000 15:03 Mar 03, 2005 Jkt 000000 PO 00000 Frm 00142 Fmt 6633 Sfmt 6633 D:\DOCS\98485.TXT HGOVREF1 PsN: HGOVREF1
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ments 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.

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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.

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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.

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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

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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.

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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 vectorborne 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 twothirds 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

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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.

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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.

[Whereupon, at 12:51 p.m., the subcommittee was adjourned.]

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