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REVIEW THE EPA PESTICIDE

PROGRAM

HEARING

BEFORE THE

SUBCOMMITTEE ON CONSERVATION, CREDIT,

RURAL DEVELOPMENT, AND RESEARCH

OF THE

COMMITTEE ON AGRICULTURE

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

SECOND SESSION

SEPTEMBER 28, 2006

Serial No. 109–40

(

Printed for the use of the Committee on Agriculture

agriculture.house.gov
COMMITTEE ON AGRICULTURE

BOB GOODLATTE, Virginia, Chairman

RICHARD W. POMBO, California

Vice Chairman

TERRY EVERETT, Alabama

FRANK D. LUCAS, Oklahoma

JERRY MORAN, Kansas

WILLIAM L. JENKINS, Tennessee

GIL GUTKNECHT, Minnesota

ROBIN HAYES, North Carolina

TIMOTHY V. JOHNSON, Illinois

TOM OSBORNE, Nebraska

MIKE PENCE, Indiana

SAM GRAVES, Missouri

JO BONNER, Alabama

MIKE ROGERS, Alabama

STEVE KING, Iowa

MARILYN N. MUSGRAVE, Colorado

RANDY NEUGEBAUER, Texas

CHARLES W. BOUSTANY, JR., Louisiana

JOHN J.H. ‘‘JOE’’ SCHWARZ, Michigan

JOHN R. ‘‘RANDY’’ KUHL, JR., New York

VIRGINIA FOXX, North Carolina

K. MICHAEL CONAWAY, Texas

JEFF FORTENBERRY, Nebraska

JEAN SCHMIDT, Ohio

MICHAEL E. SODREL, Indiana

COLLIN C. PETERSON, Minnesota,

Ranking Minority Member

TIM HOLDEN, Pennsylvania

MIKE MCINTYRE, North Carolina

BOB ETHERIDGE, North Carolina

JOE BACA, California

ED CASE, Hawaii

DENNIS A. CARDOZA, California

DAVID SCOTT, Georgia

JIM MARSHALL, Georgia

STEPHANIE HERSETH, South Dakota

G.K. BUTTERFIELD, North Carolina

HENRY CUELLAR, Texas

CHARLIE MELANCON, Louisiana

JIM COSTA, California

JOHN T. SALAZAR, Colorado

JOHN BARROW, Georgia

EARL POMEROY, North Dakota

LEONARD L. BOSWELL, Iowa

RICK LARSEN, Washington

LINCOLN DAVIS, Tennessee

BEN CHANDLER, Kentucky

PROFESSIONAL STAFF

WILLIAM E. O’CONNER, JR., Staff Director

KEVIN J. KRAMP, Chief Counsel

JOHN HAUGEN, Communications Director

ROBERT L. LAREW, Minority Staff Director

SUBCOMMITTEE ON CONSERVATION, CREDIT, RURAL DEVELOPMENT, AND RESEARCH

FRANK D. LUCAS, Oklahoma, Chairman

JERRY MORAN, Kansas

TOM OSBORNE, Nebraska,

Vice Chairman

SAM GRAVES, Missouri

MIKE ROGERS, Alabama

STEVE KING, Iowa

CHARLES W. BOUSTANY, JR., Louisiana

JOHN J.H. ‘‘JOE’’ SCHWARZ, Michigan

JEFF FORTENBERRY, Nebraska

TIM HOLDEN, Pennsylvania,

Ranking Minority Member

HENRY CUELLAR, Texas

MIKE MCINTYRE, North Carolina

BOB ETHERIDGE, North Carolina

ED CASE, Hawaii

LINCOLN DAVIS, Tennessee

STEPHANIE HERSETH, South Dakota

G.K. BUTTERFIELD, North Carolina

JOSHUA A. MAXWELL, Subcommittee Staff Director

(II)
(III)

C O N T E N T S

Page

Goodlatte, Hon. Bob, a Representative in Congress from the Commonwealth

of Virginia, opening statement ............................................................................ 2

Holden, Hon. Tim, a Representative in Congress from the Commonwealth

of Pennsylvania, opening statement ................................................................... 2

Lucas, Hon. Frank, a Representative in Congress from the State of Oklahoma, opening statement .................................................................................... 1

WITNESSES

Gray, Jim, pesticide registration coordinator, North Dakota Department of

Agriculture, Bismarck, ND, on behalf of Roger Johnson, agriculture commissioner ............................................................................................................... 20

Prepared statement .......................................................................................... 35

Gulliford, James B., Assistant Administrator, Office of Prevention, Pesticides

and Toxic Substances, U.S. Environmental Protection Agency ....................... 4

Prepared statement .......................................................................................... 30

Vroom, Jay, president and chief executive officer, CropLife America, Washington, DC .................................................................................................................. 21

Prepared statement .......................................................................................... 42

[Editor’s note: The EPA did not respond with answers to submitted questions.]
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REVIEW THE EPA PESTICIDE PROGRAM

THURSDAY, SEPTEMBER 28, 2006

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON CONSERVATION, CREDIT, RURAL DEVELOPMENT AND RESEARCH, COMMITTEE ON AGRICULTURE,

Washington, DC.

The subcommittee met, pursuant to call, at 10:00 a.m., in room

1300, Longworth House Office Building, Hon. Frank D. Lucas

(chairman of the subcommittee) presiding.

Present: Representatives Moran, Osborne, Schwarz, Fortenberry,

Goodlatte [ex officio], Holden, Cuellar, Etheridge, Butterfield, and

Peterson [ex officio].

Staff present: Joshua Maxwell, subcommittee staff director; John

Goldberg, Callista Gingrich, clerk; Christy Birdsong, and Nona

Darrell.

OPENING STATEMENT OF HON. FRANK D. LUCAS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OKLAHOMA

Mr. LUCAS. The hearing of the Subcommittee on Conservation,

Credit, Rural Development and Research to review the Environmental Protection Agency pesticide program will come to order.

Today, the subcommittee will again focus its attention on the

topic of pesticide regulation. This committee has a long history of

aggressive oversight of the Office of Pesticide Programs at the

EPA. While at times this oversight has been contentious, in recent

years we have had what I believe is a much more productive and

mutually respectful relationship.

That is not to say that we have agreed with everything that the

EPA has done. In fact, we can point to numerous examples in just

the past few weeks of actions taken by the EPA which are potentially devastating to farmers and ranchers in America. I am referring here to last week’s decision to finalize a regulatory standard

for dust in rural communities. By EPA’s own admission, the data

linking dust to health effects in rural communities is, at best, inconclusive. Despite this fact, the Agency has recklessly moved forward with a step that will cost agriculture billions of dollars to

comply with.

Of course, in the realm of pesticide policy, there have been similar problematic decisions for American farmers, decisions relating

to pesticides such as AZM and carbofuran come to mind.

Despite these negative decisions, we have had some recent successes. With the full cooperation and support of the EPA, this com-
2

mittee was able to unanimously report legislation that, when enacted, will bring the U.S. into full compliance with the global POPs

Treaty, and more importantly, give us a seat at the negotiating

table as this important treaty is implemented.

I would like to take the opportunity to examine the past, present

and future of the EPA pesticide program. In order to do that, I ask

each of our witnesses to include in their testimony a retrospective

review of the Food Quality Protection Act, to comment on the

progress of discussions with Canada regarding harmonization of

pesticide reviews, and to preview for the committee the issues that

we will need to consider for the reauthorization of the Pesticide

Registration Improvement Act. This is not a request to limit testimony to these issues. In fact, I expect several other issues will be

discussed today. My purpose is to stimulate a discussion on where

we have been, where we are, and where we are going.

And before welcoming our first witness, I would like to yield to

the chairman of the full committee for any statement he might

have.

And with that, I will yield to my ranking member, Mr. Holden.

OPENING STATEMENT OF HON. TIM HOLDEN, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

Mr. HOLDEN. Thank you, Mr. Chairman, for holding this hearing

on the proper use of crop protection products, such as pesticides,

that can help our farmers provide consumers with a safe, affordable, and reliable supply of food and fiber. Many laws and regulations oversee the application of pesticides, and we will hear from

our witnesses today about them.

We just passed the 10th anniversary of the Food Quality Protection Act. The act required EPA to reassess the safety of thousands

of existing pesticides’ tolerance by August, 3 2006. The Pesticide

Registration Improvement Act has ensured that EPA can better

meet funding and decision timelines for the pesticide registration

process; and there is also interest in harmonizing pesticide regulation so that safe and effective products can move across international borders. I look forward to hearing from our witnesses

about these issues and ways we can do a better job of protecting

both people and crops.

Mr. LUCAS. And the Chair now turns to the full committee chairman, if he has a statement.

Mr. Goodlatte.

OPENING STATEMENT OF HON. BOB GOODLATTE, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH

OF VIRGINIA

The CHAIRMAN. Thank you, Mr. Chairman. I want to thank you

for holding this hearing.

It is often said—and I don’t believe there is a member of this

committee that would disagree—farmers are the original environmentalists, unlike some who rally to the environmental banner for

political reasons. For farmers and ranchers, stewardship of the

land is critical to their lives and livelihoods. It is distressing to me
3

that this basic fact is not more widely acknowledged by those that

consider themselves environmentalists.

For nearly 7 years prior to taking over as chairman of the Committee on Agriculture, I had the honor of serving as the chairman

of the subcommittee that oversaw EPA’s pesticide program. From

that vantage point, I can attest to Chairman Lucas’ comments

about the current positive working relationship with the EPA.

While some recent decisions are troubling, and I would second the

comments of the chairman, I think it is important to recognize

when the Agency makes an effort to reach out to the agricultural

community.

In some cases, even when these outreach efforts are made, the

final decisions are not good news for agriculture. When decisions

are made based on a fair and impartial analysis of the best available data, we may not like the outcome, but we can surely respect

it. Unfortunately, not all of EPA’s decisions follow this model.

Chairman Lucas referred to three recent decisions I am sure we

will talk about at great length today. I am particularly disappointed in EPA’s decision to remove the proposed agriculture and

mining exemptions from the final air quality standards regulation.

Throughout the process, we were told that the data were, at best,

inconclusive regarding the potential health effects of coarse particulate matter in rural communities.

The EPA briefing material on the final regulation continues to

make this point. This is why EPA originally intended to exempt agriculture and mining sources from the standard. After all, if the

data is inconclusive about a health effect, then surely any measurement of the regulatory benefit will be completely arbitrary. What

is not arbitrary, however, is the compliance cost this standard will

impose.

I am reminded about some of the requirements proposed in 1997

before the last air quality regulation was struck down by the

courts. At the time, the EPA had developed guidance materials

that would have instructed farmers to wash all of their trucks and

tractors before leaving a field in order to reduce fugitive dust. As

ludicrous as these guidelines sound, I am not sure the EPA has

any better ideas, nearly 10 years later, of how farmers will meet

this standard.

In the absence of health data to justify compliance with a nearly

impossible standard, I am loathe to accept or understand the rationale for this action. I hope the EPA representatives here today

will have a good explanation for their actions.

Mr. Chairman, I again thank you for holding this hearing, and

I look forward to the testimony of the witnesses.

Mr. LUCAS. Thank you, Mr. Chairman.

And the Chair would request that other members submit their

opening statements for the record so witnesses may begin their testimony to ensure we have ample time for questions.

We are pleased to invite to our first panel at the table the Honorable James B. Gulliford, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency. Accompanying him today is Mr. William Wehrum,

Acting Assistant Administrator, Office of Air, U.S. Environmental

Protection Agency.
4

Mr. Gulliford, please begin.

STATEMENT OF JAMES B. GULLIFORD, ASSISTANT ADMINISTRATOR, OFFICE OF PREVENTION, PESTICIDES, AND TOXIC

SUBSTANCES, ACCOMPANIED BY WILLIAM WEHRUM, ACTING ASSISTANT ADMINISTRATOR, OFFICE OF AIR AND RADIATION, U.S. ENVIRONMENTAL PROTECTION AGENCY

Mr. GULLIFORD. Good morning. Thank you, Mr. Chairman, members of the subcommittee; thank you for the opportunity to appear

before you today to discuss the Environmental Protection Agency’s

efforts to harmonize pesticide labeling between the U.S. and Canada, as well as our activities to meet our statutory requirements

to protect human health and the environment from the potential

risks of pesticide use. I assure you that the Agency is committed

to working with Congress, our NAFTA, State and Federal regulatory partners and stakeholders on these important issues.

I would like to begin my testimony with the issues of pesticide

label harmonization with our Canadian regulatory partners. Under

the NAFTA Technical Working Group on Pesticides, we have harmonized our regulatory and scientific requirements and jointly registered needed pesticide products.

We now routinely collaborate with our Canadian counterparts to

share data and conduct joint technical reviews of information to

share the workload. With this cooperation, we are able to increase

the efficiencies and jointly evaluate pesticides while maintaining

our rigorous health and safety standards to help improve the availability of pesticides in the border States.

The NAFTA countries have a stakeholder process that is under

way with the States, Canadian officials, the pesticide industry, and

growers to develop and implement NAFTA labels to facilitate crossborder movement of pesticides. The working group has agreed on

a short-term strategy which involves the relabeling of existing Canadian pesticide products for import by U.S. growers. A case study

of this process has already proven successful, and over the next

several weeks, growers are going to test this process and import

the pilot chemical. From all indications, we believe the process will

be successful.

Also, U.S. growers have consolidated and prioritized a list of

chemicals that they would like to have access from across the border. That list will form the basis for selecting chemicals for a relabeling import program for the spring of 2007. To get this process

under way, several registrants have thus far offered to participate

in the import program for five pesticides.

We expect more registrants will volunteer for the program once

they have had an opportunity to analyze the case study. The longterm strategy focuses, though, on developing joint NAFTA labels

for use in both the U.S. and Canada that will be a part of the product packaging that will facilitate free movement across the border.

We are currently working with Canada and the pesticide registrants to finalize one of these NAFTA-type labels. Three pesticides have been identified for this project and another one is possible.

The United States and Canada are also in discussions on new

joint mechanisms for review of label amendments to these NAFTA
5

labels. We believe the efforts highlighted here show great promise

toward achieving a non-legislative solution to the concerns raised

by a number of members of this committee. The Agency will be

glad to keep the committee informed as this work proceeds.

I would now like to discuss the Pesticide Registration Improvement Act, known as PRIA.

PRIA created a performance-based system to improve results by

coupling fees paid by pesticide manufacturers with specific pesticide registration decision time frames, and it reauthorized maintenance fees, which provide $116 million over a 5-year period for

reviewing older pesticides.

Through collaboration with all stakeholders, we have taken several steps to improve the timeliness of our decisions and have encouraged innovative approaches to streamlined reviews without

compromising the rigor of our assessment. And since 2004, the

Agency has received applications for nearly 3,900 PRIA actions,

and for those actions, we have successfully met or beat the deadlines 99.8 percent of the time.

EPA will continue to work with all stakeholders to implement

PRIA, as well as provide technical assistance on any new or improved fee legislation for pesticide activities at EPA. Our goal is to

ensure that we have stable and adequate funding for the pesticide

review program.

And finally, I would like to briefly comment on FQPA. The Agency recently observed the tenth anniversary of the enactment of the

Food Quality Protection Act and its mandate to reregister food use

pesticides and reassess the tolerances for these pesticides within a

decade. I am proud to report we have completed reregistration for

virtually all of the food use pesticides and tolerance reassessments

for more than 99 percent of those existing tolerances.

This program has significantly advanced food safety, public

health, and environmental protection while maintaining our Nation’s economic competitiveness by assuring that growers have the

pesticide tools they need to produce a safe, abundant, and affordable food supply. And in the last 10 years, EPA has registered 250

new pesticide active ingredients and 1,600 new uses for existing

pesticides; and this effort has allowed America to shift to a newer,

safer generation of pesticides.

The United States continues to set the bar for pesticide safety

and we have raised that bar through our work under FQPA.

So, in summary, we will continue to work to harmonize the availability of pesticide products between the U.S. and Canada through

the NAFTA Pesticide Working Group, we will continue to meet the

deadlines set by PRIA, and we will continue to set the bar for pesticide safety.

Thank you, Mr. Chairman.

[The prepared statement of Mr. Gulliford appears at the conclusion of the hearing.]

Mr. LUCAS. Thank you.

One of the things that my constituents have brought to my attention pretty consistently recently are the concerns about carbofuran

and AZM. The point they make to me is basically, if pesticides that

have been on the markets for decades are now basically under

threat of cancellation, like these, are the products now a greater
6

danger than they have been in the past or has EPA simply moved

the goalpost?

That is a question that I get from my constituents. How do you

respond to that?

Mr. GULLIFORD. First of all, the products themselves have not

changed. Most formulations are the same as they always have

been.

Clearly, under the registration review process, we have looked at

additional data regarding the health effects, the environmental effects, associated with the use of these pesticides. We have also

looked at alternative products, consistent with the requirements of

the Food Quality Protection Act to register safer pesticides that

meet these same needs. So, yes, the bar has changed, that is, as

consistent with the statute of the Food Quality Protection Act

itself; and also the information that we have, better information

again on the nature of these pesticides, the risks associated with

them, but also the benefits that are provided by other new-use or

new-generation pesticides that are available.

Mr. LUCAS. Well, tell me about these EPA models that we use

to assess the ecological exposure and risk. How are they validated?

How do you determine that they are the legitimate models that

should be used?

Mr. GULLIFORD. Sure. These models have been produced over

time. They have been peer reviewed. They have been sent to

science advisory panels for their examination. They clearly are the

best models that exist for the evaluation of pesticide risks.

What we use is, then, the data that are given to us by the registrants, by the applicants for registrations. They are put into these

models to test them. And, in fact, these models were made available to industry for their consideration and development of new

products. So they are excellent models; they are the best anywhere

in the world. We continually update them every time we have new

data because, again, we take every opportunity to test the models

against real-world situations.

Mr. LUCAS. A question for you, Mr. Wehrum: What role do you

think that the Natural Resource Conservation practices can or

should play in meeting the expectations of the Agency and minimizing the particulate matter emissions?

Mr. WEHRUM. Thank you, Mr. Chairman, and I will start by offering my thanks and appreciation for the opportunity to be here

today.

We made a very, very important decision, as you well know, last

week in our review of the particulate matter standards with regards to coarse PM. I realize that many on this committee have

great concern; and I certainly appreciate the opportunity to explain

better what we have done and to explain how we have tried, and

I believe tried successfully, to address the concerns of the agriculture community.

With regard to best management practices from USDA and the

Soil Conservation Service, we realize there is a great opportunity

to rely on those practices not only for the purposes of USDA, but

also for our purposes which are, in appropriate circumstances, to

reduce or minimize the emissions of dust from an agricultural operations. We specifically address this issue in the preamble to the
7

final action that was taken last Thursday, and what we say is,

those best management practices, we believe, satisfy the obligation—under the Clean Air Act—to have reasonably available control measures or best available control measures in areas where

such measures are necessary.

It is important to point out that the vast majority of the agricultural operations of this country are in areas that meet the coarse

particle standard that we decided to retain last week. So the concern and consideration of possible control measures is limited to

very particular areas, or has been limited under application of the

standard up until now; and our prediction and our strong sense is,

it will continue to be limited to very particular areas where there

are very difficult-to-resolve air quality problems with coarse particles.

Mr. LUCAS. And in those kinds of situations, I guess what you

are saying is, I believe my constituents can turn to the NRCS for

their help in establishing practices that would then potentially

meet your requirements.

Mr. WEHRUM. That is correct, Mr. Chairman.

Mr. LUCAS. With that, I would like to turn to the ranking member, Mr. Holden.

Mr. HOLDEN. Thank you.

Mr. Gulliford, following up on the chairman’s questions on models that are used, I understand that the EPA intends to cancel the

use of AZM for fruits, such as apples and pears, and other crops.

Since there aren’t any other available alternatives, grower groups

are anxious about these pending cancellations and EPA-relied-on

studies that do not take into account rural real-world practices.

Can you elaborate on the process and model EPA uses for cancellation?

Mr. GULLIFORD. Sure, a couple of things. Thank you, Congressman.

AZM is a high-value product. It has high-value uses. It is a highvalue pesticide for nut and fruit production. We have clearly looked

at and determined there are alternatives out there. It is not a clear

case that there are a drop in substitutes for AZM, but there are

new products, both registered for use now on these commodities, on

these fruit and nut products, as well as products under development that we think are very, very appropriate as alternatives and

substitutes in different ways.

We have issued a proposed decision. We haven’t issued a final

decision. We have taken comments for over 60 days; we are reviewing those comments.

I took the opportunity to actually visit growers and registrants

in Michigan and on the west coast to hear their issues, hear their

concerns. We also visited with people concerned for the safety of

workers in these orchards and nut tree areas, but also concerned

for the environment. So it is a very difficult and challenging decision that we will make in the near future.

But our models look at the economics. They look at the importance of the actual products themselves as used in real-world situations, the availability of substitutes and alternatives; and they also

look at the concerns and effects on worker protection, worker safety
8

issues and the environment and bring us to the proposal that was

made and ultimately will bring us to a final decision on AZM.

Mr. HOLDEN. EPA does believe there are alternatives?

Mr. GULLIFORD. We believe there are alternatives.

Mr. LUCAS. Thank you.

The gentleman from Kansas, Mr. Moran.

Mr. MORAN. Thank you very much.

Mr. Gulliford, good to see you again. Thank you for being here.

Because my time is limited, although pesticides is a very important

issue, the one that is in my mind this morning is probably better

directed towards Mr. Wehrum and, again, this particulate matter

regulation.

We in Kansas, we in agriculture, we on this committee, at least

listening to the comments made previously, are baffled by EPA’s

action. I think that it lacks common sense, your own words, that

the EPA suggests that the health risks are inconclusive.

That seems to me to be a—that if you yourself determine that

the health risks are inconclusive, the question is, why are you proceeding down this path? Why did you not follow the plan that you

had intended, at least as I understand, that EPA intended to have

an agricultural exemption?

I have heard your comments, and I very much appreciate you

being here, Mr. Wehrum. Again, this was not the topic of this

morning’s hearing, but I know that you know that we all are very

interested in hearing what the EPA has to say.

The idea that we are adopting regulations that you don’t expect

there to be any enforcement problems, it worries me that we set

the stage for private entities and litigation; and even if we prevail

in that litigation, it is a very expensive process. It allows for uncertainty.

In Kansas, we only have one monitoring station, and you indicate

that generally we expect that we are and will remain in compliance. But that compliance, or that monitoring station, is in Topeka,

a different environment than in places in western Kansas. And the

current standard in which we operate was invalidated by a court

decision; it has not been enforced.

I just think that you are headed down a new path, that despite

your assurances, we have seen consequences of these kinds of EPA

decisions; and almost without exception, these are the kinds of decisions that cause at least Americans in Kansas to shake their

heads, wondering what is our government doing to us.

Mr. Wehrum, any comments or reassurances?

Mr. WEHRUM. Yes, Congressman. There is much that I can say.

You covered a lot of territory in your question.

I think it is important, first, to point out that for coarse particles,

that are called PM 10, under our regulations right now EPA has

had a standard in place for just about 20 years that covers this

type of pollution. That standard was in effect last Wednesday before we took action, and the decision of the Administrator was to

retain that standard. And his judgment was that it was necessary

to have that standard in place to protect the public health with an

adequate margin of safety, which is his obligation under the Clean

Air Act.
9

So the point I am making is, the decision, in essence, was to support the status quo, the status quo that has been out there for 20

years.

There seems to be a sense that EPA has taken a new and different, significant regulatory action that creates the specter and

possibility of a wide range of possible regulations on agriculture operations and other operations where that possibility didn’t exist before; and that is simply not true.

Our judgment and the administrator’s judgment was that the

standard was necessary to protect public health. But his judgment

also was that we have to be very, very mindful of the potential impacts of these kinds of standards on all of the various sources and,

in particular, sources like agriculture.

We full know that agricultural operations are very, very different

than the type of operations we typically regulate in this Agency.

We know a lot about power plants. We know a lot about refineries.

We have very specific regulations that deal with the very specific

issues that emissions from those types of operations create.

Agricultural operations are wholly different. We realize that, and

we are very, very careful in the regulatory decision-making that we

undertake to make sure that our decisions are carefully tailored to

the issues as we understand them.

So not only did we support the status quo that has been there

for 20 years and the status quo that, for the vast majority of agricultural operations, has resulted in no regulation for Clean Air Act

purposes; not only did we support that status quo, in my mind, we

made it better. We said many things in this preamble, beginning

with the point that you made and others have made here today,

that the decision on the science is that the science is inconclusive

with regard to certain types of coarse particles. Conversely, it is

clear under the science that certain types of coarse particles are

harmful to human health when breathed in sufficient quantity.

So the decision that the administrator made is that composition

matters when it comes to this type of pollution, and our effort and

our continuing effort will be to tailor efforts of control only to those

places where they are necessary and only to those types of sources

that seem to create hazards to public health.

That is what we tried to do in the decision last week. That is

what we are going to try to do in the upcoming years as designs

continue to be made as to what steps may need to be taken to reduce this type of pollution in the areas where it seems to be a problem.

Mr. MORAN. Thank you, Mr. Chairman.

Mr. LUCAS. The Chair turns to the gentleman from North Carolina.

Mr. ETHERIDGE. Thank you.

Good morning, Mr. Gulliford. Thank you for being with us today.

I would like to talk about something that hasn’t been a real

heavy topic this morning, but it is something of substantial concern

to our farmers in North Carolina who grow a lot of fruits and vegetables, which contribute a little over $300 million to our State’s

economy.

The United States is allowed to continue production and have

methyl bromide under the Montreal Protocol until an alternative is
10

developed. As you probably know, the Federal Government has

probably spent something over $150 million to develop such an alternative, with only very limited success to date. In fact, for many

crops, really no alternatives, as far as I know, exist right now. The

need for methyl bromide has really not diminished since we started

the process, and I think that is reflected in the fact that growers

have applied for a fairly consistent level of allocation of the product

ever since the inception of the critical-use exemption process.

I would like to ask why EPA has unilaterally cut, as I understand it has, the amount of methyl bromide for U.S. farmers over

the last few years. The Agency, I understand, has made cuts even

greater than what was sought by international partners, even

though the United States is not bound by those agreements as held

by the Court of Appeals for the District of Columbia.

Could you shed some light on this for us? Help me understand

a little better.

Mr. GULLIFORD. Thank you, Congressman. I would like to give

you a little brief overview of the process that we do use.

Each year, the Agency works with the growers and develops a

very critical assessment of the need for nominations to the Montreal Protocol for the continued use of methyl bromide. We do that

based on what we believe to be sound science and economic analyses in terms of what those needs are. It is not an independent action by EPA; it is discussed very carefully with USDA, the Department of State, CEQ, and others. And this final decision is then, as

you suggest, the amount of methyl bromide that we do nominate

to the parties of the Montreal Protocol.

We at EPA continue to look at alternatives, as you have suggested, for methyl bromide. We are looking at iodomethane as one.

We are going to look at that, its efficacy and its suitability.

Yet the next year, as we look at all soil fumigants and other

products, it is a challenging action on our part to look at those

quantities, the one that we believe is consistent again with our obligations to growers, but also our obligations to the Montreal Protocol.

Mr. ETHERIDGE. So if I understand your statement, you are saying that there are adequate amounts of it available for the specialty crop growers?

Mr. GULLIFORD. Our goal is to make sure that the critical——

Mr. ETHERIDGE. My question is, you are saying this is an adequate amount available for them or——

Mr. GULLIFORD. We believe that for critical uses there is an adequate amount available, yes. That is the purpose of the application

that we then bring to the Protocol.

Mr. ETHERIDGE. How do you define ‘‘critical’’?

Mr. GULLIFORD. Based on economic need and the availability of

alternative products.

Mr. ETHERIDGE. Is that a joint decision? When you said you meet

with the growers association, is that a joint decision or a decision

EPA makes?

Mr. GULLIFORD. We get their input. We also meet, as I said, with

the CEQ, Department of State, USDA, so it is a shared decision.

Mr. ETHERIDGE. Let me encourage you, if I may, sir. I realize

this is something we are trying to move to something else, but
11

until we do, it is a critical issue, economic issue with our growers

not only in North Carolina, but really, as you know, across the

country; and until we can find an alternative, it is important that

we help them out so that the economy can——

Mr. GULLIFORD. I do agree with you on that. It is a very important decision we make every year, and I appreciate the concern

that you raise.

Mr. ETHERIDGE. Thank you, Mr. Chairman. I yield back.

Mr. LUCAS. The Chair now turns to the gentleman from Nebraska.

Mr. OSBORNE. Thank you, Mr. Chairman. I would like to return

to the subject of carbofuran, which was broached by the chairman

earlier. And a number of us had a meeting yesterday. We met with

Secretary Johanns, and there was a great deal of concern about

this decision not to reregister this product; and let me restate, I

guess, the arguments that we heard.

Apparently there is a product that has been under review for

some time, and the thought that I heard expressed was that most

of the studies, that this decision not to reregister were based upon,

were 10–20 years old and that the industry had presented new

data to EPA. EPA had rejected the studies, for some reason, would

not consider them. So the industry is now asking for a 6-month extension whereby they might be able to provide new information to

you. And in view of the fact this product has been used for 30

years, and it is used for corn, which is a huge crop in the United

States, also potatoes and also cotton. I mean, this is a big deal.

So my question is, is it reasonable to give these people 6 months

to present new data because their studies were apparently rejected

out of hand.

Second, you mentioned that there are acceptable alternatives to

carbofuran. I would like to know what those are.

And then an extraneous third question is, you mentioned the

NAFTA label and you mentioned the United States and Canada. If

you have a NAFTA label, would not Mexico also be involved, and

other countries, because it seems like a lot of our concerns about

pesticides have to do with being south of the border, not just north.

So it is kind of a broad question, but there is a great deal of heat

being generated by this decision. And a number of people in Congress are very concerned, so I am simply carrying that concern for

you today.

Mr. GULLIFORD. Thank you.

You have a number of questions that we are a part of the question that you asked. Yes, it is true that the Agency has completed

its reregistration decision for the carbofuran and the decision was

made to not reregister the pesticide. However, there is a 60-day

comment period following that decision, and we are open to comments from the registrant, but I have not seen a request for a 6-

month extension for new data.

I would, however, say that again there was nothing surprising

about the FQPA process and we carefully looked at all of the studies and information available on carbofuran and all of the pesticides that went through the reregistration process. We didn’t reject any studies out of hand. There would have been reasons either

from an efficacy standpoint, from a technical standpoint.
12

Old studies can be good studies. There is nothing that says that

an old study is not a valuable study. Again, there is a lot of data

on carbofuran with respect to the environmental impact, the environmental issues associated with it, and all that was carefully

taken into consideration.

We also met with the registrant on numerous occasions. We are

very much open to seek comments as consistent with the 60-day

comment period that does exist. And, again, there are a number of

alternatives to carbofuran.

The concerns for corn rootworm can be addressed through pesticide pretreatment of seeds, or pesticide application at the time of

planting. And a number of those products I would be happy to get

you information on those alternative products. I think that is the

best action that I could suggest now.

With respect to the NAFTA question, most of our work has been

work with Canada because there are a lot of shared pesticide uses

and concerns from, again, northern State producers as to the availability of pesticides and the interest in accessing pesticides across

the border.

But you are correct, the NAFTA label would also be applicable

to all of the North American countries, Mexico as well.

Mr. OSBORNE. Thank you, Mr. Chairman. I yield back.

Mr. LUCAS. The Chair turns to the gentleman from the Dakotas.

Mr. POMEROY. I do thank you for allowing me to participate in

this hearing. I want to congratulate you for your very timely convening of this hearing. Clearly, we have a lot to talk about.

Referring to EPA’s testimony on page 2, frankly, what I am reading doesn’t square with what I am seeing in reality. Let me just

cite:

EPA has been working closely with Canada to address pesticide issues, including

those under the NAFTA provisions. The Working Group’s primary objective is to facilitate cost effective pesticide regulation and trade through harmonization and

work sharing while at the same time ensuring protection of human health and the

environment.

You go on to say,

EPA’s work on pesticide harmonization with Canada, which began in earnest in

1993, is providing benefits directly to the American farmer. In the long term, the

creation and ongoing support of greater harmonization of North American regulatory and scientific requirements for pesticides will ensure a more level playing

field across borders while maintaining our high standards of protection.

Is there cross-border selling of pesticides under harmonized labeling between the United States and Canada presently?

Mr. GULLIFORD. As indicated, we have worked with the NAFTA

Working Group, on pesticide harmonization. And, yes, we have a

case study now that has been done for the individual purchase of

one pesticide over the last——

Mr. POMEROY. Wait a minute. You say you have been working

at this since 1993 and you have got something that is really paying

a benefit to the American farmer, and now you tell me you have

got a Working Group project that has got a single pesticide.

In your own testimony, you say that you have got—you hope to

maybe—looking at voluntary compliance by registrants for maybe

five chemicals on the list, you are looking at a pilot program for
13

next year. Registrants have thus far volunteered three chemicals

for development of a joint label.

Thirteen years, and you have got one pesticide? That is completely unacceptable. What is more, it makes a lie of your own testimony. How can you possibly say that you have been doing all of

this work? Your goal is to harmonize and we have got one single

product?

Mr. GULLIFORD. Congressman, the initial work that was done,

starting in 1993, dealt with the protocols for pesticide assessments;

that was something that both industry in Canada and the U.S.

were very interested in. We worked on the data requirements, how

the studies would be done. We shared models. We looked at data.

Mr. POMEROY. All this is well and good, but the farmer can’t go

to Canada and buy a pesticide that is sold in Canada for the same

purpose that it is registered in the United States, bring it back

down, if the price is advantageous to him, and use it in the United

States, can he?

Mr. GULLIFORD. We are working with that to allow that to happen.

Mr. POMEROY. Until that happens, it is not clear to me that you

have provided much of a benefit for the American farmer.

We are going to hear testimony later this morning on how Canada, unlike the United States, has allowed an individual use certificate in those cases where there are identical formularies; and

that very substantial savings result, in Saskatchewan alone, in

light of price point.

Now, more often than not, the price point would flow to the advantage of American farmers because I absolutely believe chemical

companies have used the registration issue to price segment. In

fact, a hearing that we held in this committee 6 years ago brought

us testimony to that effect. They are imposing higher prices on

American farmers than they will charge Canadian farmers because

they determined the market will bear more and will contribute to

the bottom line more.

How are we going to get any headway if this depends upon the

registrants, that being the chemical company, wanting this to happen? Is it your view at EPA that this shall happen if, and only if,

the chemical company wants it to happen; or do you believe that

if it is a product that has similar use approved in Canada, approved in the United States, that in the end, harmonization ought

to flow and the farmer ought to have the choice irrespective of the

registrant’s view?

Mr. GULLIFORD. Well, I believe that the way the situation exists

right now, it does require the registrant’s interest in making that

happen.

Mr. POMEROY. Is that a good idea?

Mr. GULLIFORD. That is the authority that we have to work

under right now. We are seeing interest on the part of registrants.

Mr. POMEROY. Look, the registrants, we have got a few good

ones, and I am pleased with the cooperation that we have been

shown. I will say, it is very late and there are notable companies—

and I am just so tempted to name them, but I will forbear for the

time being—that have done nothing in terms of bringing this forward.
14

And why should they? They are price-gouging American farmers,

so the last thing they want is to allow the American farmer to go

up and get the cheaper product in Canada. So I think that relying

on the registrant is the wrong thing to do.

You are suggesting we need to statutorily change that? I believe

that there is regulatory authority to that effect.

Mr. GULLIFORD. I am not suggesting that.

What I am suggesting is that it appears that there is a path forward working with the Canadian Government, the registrants, the

Working Group that exists, to make that happen. We are seeing

registrants agreeing to that, and we think that there is an opportunity to achieve the objectives of harmonization through this voluntary process.

Mr. POMEROY. In 13 years you have got three products under supervision of the many, many products out there.

I am not seeing this work at all in that way; and I would like

to see EPA begin to, in addition to the pilot project—notably and

positively its being last developed—look at whether we really ought

to reflect on whether this should determine, ultimately—whether

the chemical company says ‘‘yes’’ or ‘‘no,’’ harmonization shall

occur.

I believe that is the fault in the whole system and needs very serious examination. I would, in fact, like the EPA to write to me a

letter, because I am out of time now, with your thoughts on whether or not this should depend upon—whether or not it is good public

policy to have this relying solely upon the chemical company and

in terms of a harmonized label should go forward.

Mr. GULLIFORD. We will respond to you and the committee in

that regard.

Mr. LUCAS. The gentleman’s time has expired.

The Chair now turns to the gentleman from Michigan.

Mr. SCHWARZ. Mr. Gulliford, you indicated you had gone to

Michigan to look at some of the—I expect the fruit farming in

southwest Michigan; is that correct?

Mr. GULLIFORD. Yes, sir.

Mr. SCHWARZ. Where were you in Michigan?

Mr. GULLIFORD. Started in Flint and went across the south central portion of the State, but we also then met with—again, to our

benefit, the cherry growers came down to us and met with us. And

yesterday I was on a conference call, and my staff were, with blueberry growers as well.

Mr. SCHWARZ. Thank you. I wondered where you were. That is

not what I want to talk about. Just a couple of things I would like

to ask you about.

One is methyl bromide. I understand the Montreal Protocol and

what it said. This is an awfully simple compound which—there is

not much in the literature, unless you are looking at different literature than I am, that indicates any human or animal toxicity;

and there is some question about the studies that indicate that

methyl bromide does the harm that it was first thought to do, or

any harm to the ozone layer.

I understand we are a signatory to the Protocol. But I also understand that the alternatives as a fumigant that is used against

fungi, nematodes, are a lot more expensive than methyl bromide.
15

So my question would be, in the interest of cost effectiveness,

why we are not doing more to perhaps try to extricate ourselves,

at least partially, from our obligations under the Montreal Protocol

so that agriculture can use methyl bromide in greater volumes

than it is now, in volumes that it was used before.

It was introduced over 70 years ago and there is no real evidence

that there is any kind of a health hazard for humans or animals

or there is any runoff because of the gas. Can you just tell me what

your thinking on methyl bromide is?

Mr. GULLIFORD. Well, you are right. Again, the concern is for air

quality and the implications that the release of the fumigant has

on ozone.

We know it is a very valuable product and that is part of what

goes into the consideration of the approach for exemptions, the application for exemption that we take to the Montreal Protocol each

year. So that is what the science tells us, and that is the basis for

our decisions.

Mr. SCHWARZ. And the reason I ask that is, if you look at some

of the other pesticides that are now being used with all of the different chemical radicals in them, we know that they do pose some

human health threats.

I was just looking at the—I asked for them to bring me the

chemical formula of AZM, and the fact that it is a kinase inhibitor;

and you know, I would agree that is a compound that, if ingested

in an appropriate amount, you have got a big problem on your

hands.

And so just posing that against good old methyl bromide, where

there is literally no danger to humans, one wonders why we are not

doing more to use the simpler and cheaper and time-tested products such as methyl bromide.

I will leave it at that. I know what your responsibilities are

there, but from the standpoint of someone who represents, at least

for a short time, a very heavily agricultural district—as I am sure

as you are, probably—in my district one wonders why methyl bromide is so bad, when you have things that are ten times as bad

that are still being used out there—in smaller volumes, I will

admit.

My second question—very quickly, if I may, Mr. Chairman—

would you define fugitive dust for me?

Mr. WEHRUM. Congressman, I think that one is in my bailiwick.

Mr. SCHWARZ. Whoever.

Mr. WEHRUM. And I would be happy to elaborate on your methyl

bromide question if that is your interest. And if not——

Mr. SCHWARZ. The chairman is going to give you the hook here

in about 2 seconds.

Mr. WEHRUM. ‘‘Fugitive’’ is a term of art that has been coined to

distinguish between stuff that comes out of stacks and stuff that

doesn’t come out of stacks. Stuff that comes out of stacks we call

point sources.

It is very clear to us and, I think, just a matter of common sense

that harmful amounts of air pollution can be generated by stuff

that doesn’t come out of stacks. And so ‘‘fugitive’’ is just the word

that we use to describe that.
16

Mr. SCHWARZ. Are there any good statistics, any good studies out

there indicating that fugitive dust, as you define it, can cause—in

concentrations that you would get in an agricultural field being

kicked up by cattle, or kicked up by the tires on a truck or that

sort of thing, can cause pulmonary disease if inhaled?

Mr. WEHRUM. Congressman, as many have pointed out to me

during the hearing today, and as we believe is true, the scientific

evidence is inconclusive as to potential threat to public health from

certain types of these coarse particles that we have been talking

about today.

And as I said earlier, the way I describe it, it is composition matters. What the stuff is made of seems, under the science and certainly as a matter of common sense, to make a difference in terms

of how hazardous it is to people.

So what the science seems to show is that stuff that is not potentially contaminated by industrial activities and human activities—

and we have coined the term ‘‘urban’’; it is a poor choice of words,

but certainly urban environments are a good example because of

automobiles and trucks and industry and all of the things that happen in the city.

Mr. SCHWARZ. You would admit there is a difference.

Fifteen seconds, Mr. Chairman.

Mr. LUCAS. Fifteen seconds on this question.

Mr. SCHWARZ. Between urban fugitive dust and agricultural fugitive dust, urban fugitive dust if you drive through Gary, Indiana,

I know what you are talking about.

Mr. WEHRUM. Yes, Congressman.

Mr. SCHWARZ. You get my drift here?

Mr. WEHRUM. Yes.

Mr. SCHWARZ. One wonders if we are not dealing in a little bit

of overkill on the agriculture side.

Mr. WEHRUM. Congressman, I fully understand the concern, and

as our administrator says, we don’t want to be in the business of

regulating dirt. And our scientific conclusion—and we go on at

great length using all the right words in the preamble, but our scientific conclusion is, composition matters and the kind of dust that

doesn’t seem to be of as great concern is the kind of dust that typically comes to rural areas, what we call ‘‘crustal,’’ which is dirt,

dust that comes from natural origin that is not likely to have been

contaminated by human activity.

Our scientific conclusion and what we say in this rule is, there

is a lesser concern for those kind of particles than the other stuff

I talked about.

Mr. SCHWARZ. I will take as a point gleaned from this that composition does matter, and if dust has asbestos particles in it or

something of that nature, it could be a danger. But I am not certain that something that is picked up by the farmer at Hullihan’s

field has the same danger.

Thank you both.

Mr. LUCAS. The gentleman’s time has expired.

The gentleman now turns to the chairman of the full committee.

The CHAIRMAN. Thank you.

Mr. Gulliford or Mr. Wehrum, when you are writing these regulations regarding this particulate matter, do you have any obliga-
17

tion to take into account cost-benefit analysis and what the consequences are to not granting an agricultural and mining exemption out in remote rural areas, where the cost of compliance to regulations that might come forward would be far outreaching any

modest benefit that might be achieved for farmers or people living

near farms.

Mr. WEHRUM. Mr. Chairman, the short and simple answer is

‘‘no.’’

The CHAIRMAN. Well, that is a shortcoming of the law and maybe

something that Congress ought to address as well. But it is certainly something that should be weighed in the balance.

It would appear that the Agency has a lot of regulatory discretion in setting air quality standards. One example of that discretion is setting separate standards for ‘‘coarse’’ by a particulate matter. Done that.

If an exemption for agricultural mining was out of the question,

why didn’t the Agency exercise its discretion and establish a separate and attainable daily standard for fugitive dust and other

coarse particulate matter in rural areas?

Mr. WEHRUM. Mr. Chairman, I will answer that in two ways. We

do have discretion under the law as to how we structure our ambient air quality standards. There is no doubt about that. I have said

several times now that composition matters, and we believe there

is no doubt about that as well.

The question is how best to design a standard that reflects the

differences and effects on human health from the different types of

particles that you see across the country. That was the great challenge to us in doing this standard.

We proposed a particular approach in December of last year and

we tried very hard to make it work, but our ultimate conclusion is,

we simply could not make that work. That was not an approach

that was well enough tailored to the differences and the effects that

we see to get the right outcome and to give us confidence that we

could defend that standard in the inevitable challenge that is going

to incur.

The CHAIRMAN. I think that should have been the best signal to

you that you should have granted the exemption for farms.

Mr. WEHRUM. Mr. Chairman, the second part of my answer is

our conclusion to keep the PM 10 standard, the daily standard that

has been in place for almost 20 years, was based in part on the desire to have varying levels of protection across the country. We believe that in rural areas there should be lesser concerns and there

should be greater latitude under the standard; and conversely, in

quote-unquote ‘‘urban areas,’’ we should have greater concern because, as I explained a moment ago, those seem to be the areas

where we would expect particles to be contaminated by stuff.

The CHAIRMAN. Your actions seem to contradict your words. The

EPA has stated—the Agency has stated that it is requiring the

States to expand the number of rural monitoring sites; and I would

like to know what provisions you have made to ensure that State

and local regulators focus on urban and industrial sources of coarse

particulate matter that are of real concern, rather than rural

sources from agriculture and mining.
18

Mr. WEHRUM. Mr. Chairman, that is a great question and a

great issue. And we have done two things in the monitoring part

of this regulation that I think are very important and will help,

and certainly help the next time decisions have to be made. As you

know, under the law, we have to do this every 5 years.

One thing we have said is, as—well, we have done three things.

One is, we think there are too many monitors out there and some

of the monitors are in the wrong places.

The CHAIRMAN. Why don’t you have some more?

Mr. WEHRUM. I will get to that in a moment.

Part of what we said is, we ought to rationalize our monitoring

network and we ought to focus our resources in the places we care

about the most. So we emphasize the need and the desire to put

more PM monitors in the urban areas because that is where we believe the greatest concern is.

The second thing we have done is, we have asked for more monitors to be placed, and some of those monitors in rural areas, but

these are monitors that are designed to look specifically at the

coarse—the sizes of coarse particles we care about the most. And

they will be designed to allow us to speciate—that means, do chemical analysis—so we know what the composition is.

Those are monitors that are going to be enormously helpful in

doing further research, doing further science; and our goal and our

strong desire is to have much better information the next time this

decision has to be made. If we think what is true right now turns

out to be true, based on that information, then the Agency will be

able to act in a definitive manner, as we did in other aspects of this

rule.

For instance, we rescinded the annual coarse particle standard

that also had been in place for almost 20 years, and we rescinded

that standard in this action based on determination that the scientific evidence does not support any concern with exposure to

these coarse particles, with any significant threat to human health.

The CHAIRMAN. If you don’t have a plan for what you are going

to do no matter what you discover while it is out there, I will just

conclude that dust happens, and it is going to happen a lot on

farms just because of the nature of providing a food source for the

American people, and to continue this stepped-up, what I would

call, ‘‘harassment’’ of farmers by essentially gathering more and

more information about something for which you have no solution.

I mean, the last time this came up, some of the solutions were

washing trucks and tractors as they left farmers’ fields and other

things that are just absolutely impossible to comply with. Unless

you have some idea what you are going to do with this, I don’t see

the point of gathering the information when you already know that

farms kick up a lot of dust.

Mr. Chairman, if I might, I would like to ask one question of Mr.

Gulliford.

Mr. LUCAS. Of course.

The CHAIRMAN. To change the subject here, regarding the newly

constituted Human Studies Review Board, there appears to be duplication between the HSRB and the Scientific Advisory Panel, and

I wonder if you could explain the respective roles of those two
19

boards and how you ensure that there is no overlap in their mission and activity.

Mr. GULLIFORD. Yes. Thank you, Mr. Chairman.

They are two distinct boards, and they do perform different functions on behalf of the agency. The Science Advisory Panel looks at

the technical scientific issues associated with pesticide review, pesticide decisions that are made, how we do our risk analyses, these

types of activities, so they deal with those technical issues.

The Human Studies Board looks at the ethical issues associated

with whether or not the agency should consider human studies in

its decision-making with respect to pesticide registrations. So they

are very distinct, and our goal is to continue to work to better define the roles and functions in such a way that assures there is no

overlap on the part of those two boards.

The CHAIRMAN. Thank you.

Thank you, Mr. Chairman.

Mr. LUCAS. Thank you, and the Chair wishes to thank the panel

for your insights, and you are now dismissed, gentlemen, and we

invite our next panel to the table, and for the introduction of the

first witness on the second panel, when it is appropriate, the Chair

would like to turn to the gentleman from North Dakota, Mr. Pomeroy, to introduce the first of our two witnesses on the second

panel.

Mr. POMEROY. I want to thank you very much for allowing me

to introduce a constituent of whom I am very proud. Jim Gray has,

for many years, worked for the North Dakota Department of Agriculture, headed up the portion of control looking at the registration

activities and the regulatory responsibilities of the Department. He

has been someone that has been a real leader in terms of evaluating the implementation of the NAFTA principles, both by the EPA

and the adoption of it by the industry. He played a principal role

6 years ago in expanding what appeared to be a legal opportunity

relative to an import of a pesticide named Achieve.

The State Agriculture Department’s role at that time resulted in

a savings to farmers of tens of thousands of dollars and, in fact,

in some instances, thousands of dollars per farmer in allowing the

accessing of the cheaper product for identical use south of the border as opposed to north of the border. So I do not suppose there

is a person in the country who knows more about this business of

pesticide harmonization so particularly important on the northern

border but even beyond that because I believe, if the market truly

is harmonized, we are going to see a price competition in the pricing of farm chemicals far beyond what we have ever seen, and it

is to the benefit of all of our constituents. So it is my pleasure to

introduce Jim Gray.

Mr. LUCAS. Thank you, Mr. Pomeroy, and joining him today is

Jay Vroom, president and CEO of CropLife America here in Washington, DC, and with that, Mr. Gray, please begin when you are

ready.
20

STATEMENT OF JIM GRAY, PESTICIDE REGISTRATION COORDINATOR, NORTH DAKOTA DEPARTMENT OF AGRICULTURE,

ON BEHALF OF ROGER JOHNSON, AGRICULTURE COMMISSIONER

Mr. GRAY. I thank you, Mr. Chairman.

My name is Jim Gray. I am the pesticide registration coordinator

with the North Dakota Department of Agriculture, and I am here

today on behalf of North Dakota Agriculture Commissioner Roger

Johnson. I work with the EPA’s Office of Pesticide Programs frequently on pesticide registration as well as pesticide regulatory

issues, especially staff from the EPA’s Registration Division.

I have the highest regard for the work that EPA does in regulating pesticides, and the EPA’s pesticide regulatory programs are

widely considered to be the most rigorous in the world, usually setting the standard of how pesticides are truly evaluated for their effects on health and safety.

I would like to especially call the subcommittee’s focus on the

work that EPA does on the issue of North American pesticide harmonization as part of the Agency’s participation in the NAFTA

Technical Working Group. The Technical Working Group contains

pesticide regulatory staff from the EPA as well as their counterpart

agencies in Canada and as well as in Mexico.

Now, the actual term ‘‘harmonization’’ means different things to

different people, but I think that we can’t truly claim that we are

harmonized until we can meet four different criteria. The first is

to create a system that allows for the free trade in pesticide trade

commodities across North America, and the second is to create a

system that allows for the free trade in the actual pesticides, themselves. The third criteria is to create a system that allows for the

equal access to pesticide uses so that growers in one country have

access to the same pest management tools as their counterparts,

and the fourth is regulatory harmonization so the registrants can

obtain pesticide registrations with similar data along similar

timelines. The EPA works with these other agencies and the Technical Working Group on all four of these areas.

Now ‘‘harmonization’’ is a high-priority area. It is a major issue

in northern border States like North Dakota especially as it pertains to creating a North American pesticide market. Barriers currently exist in Federal law and regulations that prevent U.S. farmers from importing and using lower-priced Canadian pesticides

without the consent of the registrar even if the Canadian product

is identical to one registered for use in the United States.

The system of artificially segmented markets has resulted in significant pesticide price disparities and significant economic impacts

to U.S. farmers. A recent study from North Dakota State University indicated that U.S. farmers could save $178 million per year

if they could access their pest management tools at prices available

north of the border, and these price disparities go both ways. A lot

of Canadian growers are also upset by those products that are

more expensive in Canada than in the United States.

Now, at the NAFTA Technical Working Group stakeholders’

meeting less than a year ago, growers from the U.S. and Canada

strongly requested that the Technical Working Group form a sub

team to specifically look at creating a North American market for
21

pesticides. The Working Group agreed to that request, and has

formed a sub team that contains staff from the U.S. EPA and Canada’s PMRA, registrants and growers from both the U.S. and Canada. I am also a member of that sub team.

I am happy to say this sub team has made pretty good progress

in the last year. We are looking at both long-term and short-term

solutions to allow for the transport or movement of the pesticides.

On the long-term front, we are looking at the use of NAFTA labeling as a means to desegment those markets, and although we are

using the term ’’NAFTA labeling,’’ we are at the present time focused solely on joint U.S.-Canadian labeling. We are at the present

time looking at various formats, but I am more confident than ever

that NAFTA labeling is doable from a regulatory point of view. We

are also looking at a short-term home strategy that would mimic

the Own Use Import process that is currently available to growers

in Canada to import lower priced U.S. products, and we have a

pilot for that project, for that short-term strategy, and we should

see products moving across the border using that short-term strategy in the near future.

As soon as we have eliminated all of the regulatory barriers to

NAFTA labeling, the next step is to look at strategies that will

allow for the widespread use of that NAFTA labeling, and at least

to date, registrant participation in the subgroup has been positive,

and we are looking at creating solutions that will benefit all stakeholders.

However, we may very well be back in front of the U.S. Congress

to discuss statutory changes needed for the widespread adoption

and use of NAFTA labeling. This may be the actual creation of real

world incentives to registrants for use of NAFTA labeling or we

may have to look at a requirement for the use of NAFTA labeling

if the identical formulation is available in both countries. I am

hopeful that we can find a win-win solution that will result in the

widespread adoption and use of NAFTA labeling in the near future,

and to their credit, some registrants have joined the process, realizing that the time has come to desegment the U.S. and the Canadian markets and allow for the cross-border movement of products.

On behalf of the North Dakota Agriculture Commission, I would

like to thank those registrants who have been working with us to

create both short-term and long-term strategies, and finally, I

would once again like to thank the EPA for its leadership on this

issue and in helping keep stakeholders focused on resolving barriers to the use of NAFTA labeling.

Thank you.

[The prepared statement of Mr. Gray appears at the conclusion

of the hearing.]

Mr. LUCAS. Thank you, Mr. Gray.

Mr. Vroom, whenever you are ready.

STATEMENT OF JAY VROOM, PRESIDENT AND CEO, CROPLIFE

AMERICA

Mr. VROOM. Thank you, Mr. Chairman, and good morning.

My name is Jay Vroom, and I am CEO of CropLife America, the

trade association for the agricultural chemicals, manufacturers and

distributors in the U.S.A. I want to thank you, Mr. Chairman, and
22

members of the subcommittee for convening this oversight hearing

on topics of pesticide regulation.

There, indeed, are a myriad of key issues that merit the ongoing

attention of the committee, and we appreciate not only this hearing

but the nearly daily focus on all of these issues that is evident on

the work of the committee staff and many of you, the Members,

who care about keeping safe and effective pesticide products available as vital tools used by American farmers and a wide variety of

other essential pesticide applications, including public health protections, structural pest control, vegetation management for road

and utility rights-of-way, just to name a few.

In our written testimony, we mentioned 11 top pesticide issues,

including five key benefit areas. The six regulatory issues that we

highlighted included international regulatory harmonization, the

FQPA-tenured anniversary, PRIA, the Endangered Species Act,

Clean Water, nonpoint source concerns, and any clinical trial data.

Also worth a mention but not in our written testimony is we

need to get EPA regulatory requirement for empty pesticide plastic

containers for recycling. This stewardship matter has been led by

CLA members for over 15 years with a voluntary program called

the Agriculture Container Recycling Corporation that collects and

recycles these containers effectively, but in order to get full industry support of this ongoing effort, we will need EPA requirements.

The House appropriations bill for EPA funding for fiscal year

2007 has language instructing the EPA to quickly address this regulatory need. We support that language and look forward to working with the Agency to complete this new initiative to broaden the

collection of recycling of this important plastic and make this stewardship a fair proposition for all of our companies.

Also worth mentioning is the need to get the PIC and POPs enabling legislation and ratification done in this Congress, and we

hope that the work that you have done in this committee will see

through to fruition.

I would like to spend a little more time this morning talking

about international regulatory harmonization if I may. Indeed,

there are big differences still out here, and many of you have already touched on this, and I certainly respect the positions that

Congressman Pomeroy has already articulated and Mr. Gray has

discussed and addressed about the need to continue to make better

real progress.

Over 18 years’ worth of U.S.-Canada regulatory harmonization

and having the small handful of results that have been evidenced

by EPA’s testimony this morning is clearly not enough progress.

There are big differences between the U.S. and Canada farming

practices. Weather, crops, soil all vary widely. Two and now three

of our member companies have decided to step forward, as Mr.

Gray has indicated, for pilot initiatives around some Own Use

product reimportation. We support this, but we also support the

broader need for a NAFTA label option that will deliver real results.

There are substantial differences still in the way the two countries regulate our products. For instance, Canada requires submission and review of efficacy data while the U.S. EPA does not. The

U.S. obviously has a mountain of Endangered Species Act coordina-
23

tion and compliance requirements to achieve here in the United

States. Canada has nothing identical or even close to the same

kind of thresholds to registration compliance.

It is clear that our marketplace is in transition, and I would offer

that I had the experience of being invited by Senator Burns to

come to a field meeting in Montana a year ago to talk with farmers

about their concerns with regard to the agricultural economy and

the cost and availability of inputs. I appeared there with representatives of the crop insurance industry, the fertilizer industry and energy suppliers. Not one farmer in that audience that I was before

in Montana a year ago was concerned about or expressed concern

about pesticide prices and availability at that time, and indeed, we

know that our marketplace peaked in 1997 when U.S. pesticide

sales for agricultural uses hit $9 billion in 2006. We expect the

U.S. market to be below $6.5 billion. That is a $2.5 billion decline

on a $9 billion base. Our industry is a shadow of what it was less

than 10 years ago, and I would suggest that the farmer has seen

a real benefit in terms of that competition already.

Lastly, Mr. Chairman, I would like the opportunity to come back,

if during the question period there is time, to talk a little bit more

about the Human Studies Review Board question that Chairman

Goodlatte raised with Mr. Gulliford because I think there is a little

more information that should be corrected for the record on that

matter.

Thank you very much.

[The prepared statement of Mr. Vroom appears at the conclusion

of the hearing.]

Mr. LUCAS. Thank you, Mr. Vroom.

Mr. Vroom, you indicated your support for reauthorization of the

Pesticide Registration Improvement Act. Are you seeking a clean

reauthorization or are there amendments under discussion and

consideration that would be advocated?

Mr. VROOM. Thank you, Mr. Chairman.

We do believe that most of what is existing authority for pesticide fees and registration improvement in the PRIA context is exactly what is needed for reauthorization, but we have learned that

there are a few minor changes that are appropriate. Our coalition

of industry representatives are now meeting with the same representatives of the environmental community that all came together to support PRIA 21⁄2, 3 years ago. We believe that we will

have agreement between industry and the environmental community on a package that we will be ready to present for your consideration perhaps in a matter of days, but again, I do not think that

what we are likely to propose will be substantive changes, and we

look forward to working with you and the full committee on seeking an expeditious and an effective reauthorization to PRIA.

Mr. LUCAS. And you have my curiosity up. Expand on the human

studies issue.

Mr. VROOM. Well, I think that Mr. Gulliford actually misstated

the charge that the Agency has given to the Human Studies Review Board, and in his defense, all of this was crafted long before

he came to Washington and accepted the current job that he currently serves in, and we adamantly disagreed with this proposal

when it was a proposed rule establishing the Human Studies Re-
24

view Board by the Agency that its scope is, in rule, explicitly to not

only look at and review the ethical considerations of human clinical

trials for pesticide risk assessment but also the scientific validity.

We said then and we still believe today that is duplication of effort

that has already been accomplished and invested in by EPA staff

and numerous other outside, independent stakeholder review

boards, including the Science Advisory Panel and a number of Federal advisory committees that advise the Agency on scientific validity, and unfortunately, we have the first problem, in our view,

around that duplication with the Human Studies Review Board

having been charged at their last meeting at the end of June with

reviewing agricultural handler exposure data from a task force that

is made up of CropLife members, and because they were given

11,000 pages of information to review by this volunteer board of

independent science and ethicists, they were not able, with the 2

weeks that they were given time to review this information, to

make an adequate analysis of the ethics let alone the scientific aspects. The scientific aspects of the agricultural handlers’ exposure

data development were many, many years ago agreed to in terms

of scientific validity by EPA and other advisory groups that provide

outside, independent counsel to the Agency, and so we now have

a potential crisis with regard to the consideration of millions of dollars’ worth of data that the industry has generated and EPA has

already used in other regulatory decisions to make judgments on

the safety and efficacy of pesticide products.

So I think we do have a problem. It is one that I believe the

Agency can correct, but there is duplication, and it is a problem

that does need to be attended to and fixed.

Mr. LUCAS. Eleven thousand? 2 weeks to review?

Mr. VROOM. Correct.

Mr. LUCAS. The Chair now turns to the ranking member, Mr.

Holden.

Mr. HOLDEN. Thank you, Mr. Chairman.

Mr. Vroom, what are some of the factors that contribute to pesticide prices in general and, more specifically, the difference in

prices across borders?

Mr. VROOM. Well, first of all, I should remind the committee

that, as a trade association, we are, first and foremost, very careful

to comply with the antitrust statutes of the United States, and we

collect no direct data with regard to sales and prices. However,

there is much publicly available information that is out in the literature about markets and prices and product availability and demand.

So I would say that the biggest factors are the supply of available products and the demand that farmers create for those products, and one of the factors on the supply side has to do with the

evolution of the marketplace as products have their patent protections expire, and that is the biggest driver in the decline of the

total industry sales, as I indicated in my remarks, for our industry

having gone from a $9 billion peak in 1997 down to about $6.5 billion this year. It is the fact that we have a lot of products that

farmers rely on that have gone off of patent, and now there are

many more generic alternative products competing for that same

acre of treatment that the American farmer creates in the way of
25

demand by choosing his crop selections and making assessment on

what kind of weed, insect and disease control that he or she may

need.

With respect to what causes the differences along international

borders, the fundamental fact is that our products are regulated by

sovereign nations, and in the case that we are really most focused

on here today, the United States and the Government of Canada

are two separate sovereign nations, and they reserve the right to

make their final regulatory decisions on what products are approved for use. There are a lot of similarities across the demand

landscape for farmers on either side of the U.S.-Canada border, and

there are a lot of similarities of product availability, but there are

a lot of differences, some of which have been driven by some of the

regulatory differences.

I believe, as Mr. Gray has indicated, that the NAFTA Technical

Working Group has shown some early indications at their last

meeting of making some real progress on helping further harmonize and get to more NAFTA-label kind of places where less of

this kind of trade irritant kind of concern will be commonplace in

the future, but I would agree with Mr. Pomeroy’s comments earlier

that the progress that we can show to date after 13, 15, 17 years

is not adequate. We have had much, as an industry, the same kind

of experience or frustration with the OECD harmonization process

and had to get to the point of threatening to pull out our industry

support of an OECD harmonization process for pesticide regulatory

harmonization because we were seeing similar kinds of lack of real

progress, just lots of meetings with lots of Government authorities

going to many, many more meetings but no progress. So we do

identify with the frustration, and we are in full support of the kind

of progress that now seems to be evident in the NAFTA TWG.

Mr. HOLDEN. Thank you, Mr. Chairman.

Mr. LUCAS. The Chair now turns to the gentleman from Michigan, Dr. Schwarz.

Mr. SCHWARZ. I do not have a specific question, but I was

amazed at the 91⁄2 to 61⁄2 figure, and if I can use an analogy, would

you say this is like a pharmaceutical going off patent and a generic

becoming available? It is essentially the same thing, is it not?

Mr. VROOM. Yes, that is exactly right. Yes. Right.

Mr. SCHWARZ. So the follow-up question to that is:

Pesticides are, in many instances in this day and age, pretty

complex chemical compounds, in fact, very complex chemical compounds. Is your association confident that a secondary or a tertiary

or quaternary manufacturer of this compound that could have been

developed by Dow, as an example in my State of Michigan, or another nationally known or internationally known company—is the

quality the same?

Mr. VROOM. There have been instances where generic products

have been sold in the marketplace and contaminants and other

manufacturing defects have been found to result in a lack of full

efficacy, but I would say that the safeguards that are in FIFRA,

which is the law that is in the jurisdiction of this subcommittee,

provide a very good safety net for catching those kinds of problems

early on, and those could be manufacturing defects from a generic

as well as the original discoverer of the molecule, and the law does
26

not discriminate between the two, but we do have good quality control, chemistry standards, plenty of authority for EPA to regulate

in this area, and lastly, we have got plenty of marketplace competition so that, when competitors watch each other, there is plenty of

opportunity for that kind of discovery.

We have had some instances where a ‘‘me, too’’ registrant

claimed that they had identicality of product and then sold product

in the marketplace, and farmers suffered crop damage, and it

turned out that this one secondary ‘‘me, too’’ manufacturer had

committed fraud by claiming that they were actually sourcing their

material from the originator of the product when in fact they

bought one small unit and then sourced the rest from a generic

supplier from Asia, so——

Mr. SCHWARZ. Mr. Vroom, who does the chemical analysis and

assay routinely or when there is some question about efficacy? Is

it somebody in the agriculture or chemistry departments in some

of the universities like with North Dakota? Would you send something out to Grand Forks from Fargo to be analyzed or, in Michigan, we would send it off to East Lansing, to MSU.

Who does this or does the industry do it?

Mr. VROOM. Most of the expert chemistry, analytical capacity is

in the independent contract laboratory community in the United

States and around the world, in fact. Although there certainly is

plenty of that kind of scientific capacity in most of the major universities, this kind of the mass spectrometer, gas chromatograph

capacity is unbelievably widespread today, and so the capacity to

do that at many universities is certainly there, but most of the

time, because EPA also has authority to create and implement

what is called ‘‘good laboratory practices standards’’ for pesticide

chemistry, analytical laboratories, only a small handful of those

laboratories are so certified and inspected regularly by EPA. So my

guess is that there are not too many EPA pesticide, GLP-certified

laboratories in universities around the country. They would be

doing other kinds of research, more on the applied field research

side.

Mr. SCHWARZ. Your level of confidence then is high?

Mr. VROOM. Yes.

Mr. SCHWARZ. Thank you.

I would just say, Mr. Gray, even though I am from Michigan, I

am very familiar with your State because I have to drive across it

a couple of times every year on that high line. I have a home in

Montana. I love to see the great big fields of sunflowers and all the

Durum wheat growing in North Dakota, and I am familiar with the

pasta co-op. You still have North Dakota to make that good pasta

from the good Durum wheat that you grow.

I yield back to the chairman.

Mr. LUCAS. And, on that note, we will turn to the gentleman

from North Carolina.

Mr. ETHERIDGE. Thank you, Mr. Chairman.

Mr. Gray, you mentioned four criteria that we need to meet in

order to have pesticide harmonization.

How far do you think we have gone in meeting those goals, and

have there been issues since the passage of NAFTA that has created a problem?
27

Mr. GRAY. Congressman, yes. Let’s talk about each of those four.

The first one, creating free trade in the pesticide-traded commodities, the major barriers there are differences in what we call ‘‘maximum residue limits’’ or ‘‘food and feed tolerances’’ in the U.S., and

when there are differences in those levels, that can create a trade

irritant. The Technical Working Group has been working with

growers that ask them to come forward with lists of differences in

those MRLs that have caused trade irritants, and slowly but surely, we are getting through that list, and we are getting those differences and MRLs resolved.

The Technical Working Group has also agreed to a protocol for

setting those maximum residue limits, so at least for new residue

data, the three agencies should arrive at the same MRL for doing

the exercise independently, but they should arrive at the same

MRL, eliminating future trade irritants.

In terms of equal access to pesticide uses, again, the Technical

Working Group has really looked to growers to come forward with

lists of product uses that are not available in their country but in

one of the other two NAFTA countries, and again, slowly but surely, those differences have been actually resolved.

On the regulatory realm, this has been the focus of the Technical

Working Group for much of its lifespan. In that realm, it really depends upon who you ask. If one asks the EPA and PMRA and

CICOPLAFEST, they will tell you that they have made huge

strides, and in my opinion, I think that they have. Others may very

well disagree with that, but it is my understanding that registrants

can, in essence, prepare a similar data package and submit it for

registration to all three of those countries, and they have done

many, many joint reviews and work shares that have resulted in

registrations being granted faster than if each country acted on

their own.

As to one of those components that we have made the least

progress is the pesticide realm, creating a North American market

for pesticides. This is has been a thorn in my side, and until recently, we have made very, very little progress. In fact, since

1993—the Congressman is right—we have very few things that we

can point to as a success for allowing for the transport or movement of products.

Mr. ETHERIDGE. Good, and in that light, having raised that issue,

Mr. Vroom, let me ask you to hear from, really, the consumers—

farmers—that it is a considerable fluctuation in the pesticide process from year to year, and, gentlemen, I hope you will talk about

that.

The second part of that question, maybe more specifically, is why

is there a difference between the borders and, thirdly, why the

same chemical is cheaper when they are imported from Canada,

even though they have got to have transportation and all of the inspections at the border, than they are when they are produced

right here in the United States, the same products.

Maybe you can help me explain that to the people who buy those

chemicals.

Mr. VROOM. Certainly.

While I think there has been fluctuation and, again, a steady de- cline from $9 billion to $6.5 billion, there is a fluctuation that has
28

resulted in my association having fewer member companies, fewer

employees in those member companies and, frankly, less capacity

to continue at the same level as we had underway in the 1990’s in

research and development, looking for newer or better products. So,

indeed, $2.5 billion less is being spent by the American farmer

today than in 1997 on pesticide products for the production of crops

in the United States.

Are there individual products that may be priced differently on

either side of any international border? Certainly. Are there as

many that have significant price differentials on either side of the

U.S.-Canada border as there were in 1997? Absolutely not.

We have been asking, pleading, with the USDA to redo the study

that they did in the late 1990’s that gave us the best national look

at the data, and for some reason, we have been unsuccessful with

the Bush administration in convincing them that this is a worthwhile undertaking, and so, if I might, I would very much appreciate the support of this committee’s joining us in continuing to ask

USDA to update that study along with their counterparts in Canada so that we would have a better handle on what the real issues

are.

Mr. Gray has indicated that farmers on both sides of the border

have submitted lists of products that are of concern, and that is

certainly a starting point, but that is a snapshot—it is anecdotal—

and again, I think it would be very helpful for us if the Bush administration would step up and have USDA renew that work.

Mr. Gray referred to MRLs and harmonizing MRLs, which is so

that treated agricultural products can move freely back and forth,

and that is a very important issue, and on page 4, at the bottom

of page 4 of my written testimony, we talk about the fact that, just

recently, the Canadian Government has proposed a sweeping

change to take off the books default tolerances for many, many pesticide product residues that are not registered in the United States.

For many years, they had a default level where, below a certain detection limit, it was a ‘‘so what’’ level, and our treated agricultural

products could move then freely into Canada. All of a sudden, they

proposed taking away all of those exemptions, if you will, and the

consequence one would have to wonder is are they just protecting

Canadian farmers. I do not know the exact drivers for this, but you

would have to have that suspicion, which leads to another point

that I think is important to bring up for the record here today,

which is that we all have good intentions, but you all can only control the Government on this side of the border, and this is a partnership that is going to require transparency and forthrightness on

the part of both countries, and I think this stunt by theCanadian

Government is a good reminder that, on any given day, they may

have political pressures that drive them to make decisions that are

more protectionistic than not, and so it takes two to tango here,

and we need to hold their feet to the fire.

Mr. ETHERIDGE. Thank you.

Thank you, Mr. Chairman. Mr. Chairman, I would encourage the

Chair to take that under consideration in asking the Department

to do that study.

Mr. LUCAS. The Chair now, after much anticipation, turns to the

gentleman from North Dakota, Mr. Pomeroy.
29

Mr. POMEROY. I thank the chairman.

I have always enjoyed working with Jay Vroom, and know he has

a difficult case to present today of some companies that are now

beginning to work cooperatively on a voluntary registration, others

maintaining the hard line, but gee, I have got to tell you. From

your testimony, I draw that there are 16,115 registered products in

the United States, 5,274 registered products in Canada. We have

heard from the EPA that there is something like one product that

has been approved for a harmonized label, and they are working,

maybe, on two others out of those thousands and thousands of

products, and then, in your testimony on page 2, you have this long

list of imposing problems in terms of moving toward pesticide harmonization, although it has been the law of the land since 1993,

and then you say you are for it. Well, this is the case where actions

speak louder than words.

The thrust of your organization, in my opinion, has been to resist

at all costs this move toward harmonization. I am surprised you

didn’t get a message, when you were in Montana, about costs continuing to be a concern north versus south of the border.

Mr. Gray, I would just ask you: Are pricing disparities north versus south of the border continuing to be a concern to the farmers

that you are dealing with?

Mr. GRAY. Congressman, in my State, yes. I hear frequently from

North Dakota farmers and crop consultants who do all sorts of

business in Canada to buy washing machines and clothing and

even a lot of agricultural inputs—fertilizer and seed and their farm

machinery. They are frustrated that, although they can buy all of

those other inputs, they cannot buy chemicals, and they always

question why, and so it is a major issue in North Dakota. It does

have a big effect on the bottom line of North Dakota producers, and

it is a real issue. It is not just a North Dakota/Montana issue. This

is a national issue.

Mr. POMEROY. You have taken a very positive tact with your testimony, so let me try and reflect a little more of a positive framing

of this issue with the rest of my time.

Work is underway in the Working Group. You have another

meeting in December of this Working Group, and you have a couple

of pesticide companies that are participating in the cooperative

basis, a couple of Mr. Vroom’s members.

What can we expect? As we look at this situation with enormous

frustration, setting that aside, what can we realistically expect we

will achieve out of this December meeting that might have relevance on the nextcrop year?

Mr. GRAY. Well, Congressman, I think, at the next meeting of the

sub team, we should have a definitive word from the regulators

that NAFTA labeling is doable from a regulatory point of view. The

only thing left is for registrants or a registrant to step up to the

plate and to start putting NAFTA labels on their containers, and

so, for this upcoming growing season, we are going to have a small

number of products crossing the border as part of this short-term

pilot that is being called the ‘‘American Own Use Import System,’’

and I would hope that we would also start seeing some products

with NAFTA labels crossing that border.
30

Mr. POMEROY. I think monitoring the progress on that will be

very important for this committee. Quite frankly, there is just no

way 6 years should have passed since you had last focused interest

on this until now, and I think that it would be helpful for us if you

would keep us informed.

So, following the December meeting, would you write to the

chairman and to all of us, the subcommittee members—I would

like to be copied on that letter also—about what occurred at the

meeting and what you see in terms of voluntary progress for the

crop year ahead.

Mr. GRAY. I would be more than happy to do that.

Again, we are committed to a scenario that is a win-win, and

hopefully, we will have some registrants that will voluntarily step

up to the plate and do this.

The expectation of me and growers is we expect to see NAFTAlabeled products being imported this growing season. If we don’t,

we will most likely be back in front of this body, talking about legislative solutions to this issue.

Mr. POMEROY. I look forward to working with you on legislative

solutions because I am absolutely out of patience. I think it is hard

to move to a win-win when you have got a win-lose business plan,

and I believe pricing disparities for the same product for the same

application, north versus south, because the market will bear a

higher price south is nothing less than price gouging farmers for

the bottom line, and that is a losing strategy for the American

farmer. I think, over the long run, it is a losing strategy, and it is

not sustainable for the membership of Mr. Vroom’s organization. So

it is hard to move from a, basically, win-lose business plan to a

win-win outcome, but it is high time we move here. This business

of public policy tolerance of price discrimination is done, and so I

am very hopeful that your more diplomatic efforts at trying to

move this over the goal on a voluntary participatory effort with the

registrants, with EPA will produce something that maybe will show

that things are moving even without further legislative attention

by this committee, but I am certainly ready to act if that is what

it requires.

I thank the gentlemen.

I yield back, Mr. Chairman.

Mr. LUCAS. Thank you. The gentleman’s time has expired, and

all time has expired for the questions.

Without objection, the record of today’s hearing will remain open

for 10 days to receive additional material and supplemental written

questions from witnesses to have answered composed by the members of the panel.

This hearing on the Subcommittee on Conservation, Credit,

Rural Development, and Research is adjourned.

[Whereupon, at 11:41 a.m., the subcommittee was adjourned.]

[Material submitted for inclusion in the record follows:]

STATEMENT OF JAMES B. GULLIFORD

Good morning, Mr. Chairman and members of the committee. Thank you for the

opportunity to appear before you today to discuss the Environmental Protection

Agency’s efforts to harmonize pesticide labeling between the U.S. and Canada as

well as our activities to meet our statutory requirements to protect human health
31

and the environment from the potential risks of pesticide use. I assure you that the

Agency is committed to working with Congress, our state and Federal regulatory

partners, and our stakeholders on these important issues.

PESTICIDE LABEL HARMONIZATION

I would like to begin my testimony with the issue of pesticide label harmonization

with our Canadian regulatory partners. Under the North American Free Trade

Agreement (NAFTA) Technical Working Group on Pesticides (TWG) and other international fora, EPA has been working closely with Canada to address pesticide

issues, including those under the NAFTA provisions on Sanitary and Phytosanitary

Standards (SPS).

The Working Group’s primary objective is to facilitate cost effective pesticide regulation and trade through harmonization and work sharing while at the same time

ensuring protection of human health and the environment. Together, we have developed harmonized regulatory and scientific requirements and jointly registered needed products in support of the principles of sustainable pest management. EPA’s

work on pesticide harmonization with Canada, which began in earnest in 1993, is

providing benefits directly to the American farmer. In the long term, the creation

and ongoing support of greater harmonization of North American regulatory and scientific requirements for pesticides will ensure a more level playing field across borders while maintaining our high standards of protection.

Under the NAFTA Working Group, the United States and Canada have initiated

a stakeholder process including Canadian and U.S. industry, growers, grower representatives, and pesticide distributors to develop and implement strategies to facilitate cross-border movement of pesticide products. The focus of our work has been

to develop both a short- and long-term strategy to facilitate trade in pesticide products across the U.S. and Canadian border. It is important to note that while this

work aims at facilitating trade, it will in no way compromise U.S. health and safety

standards.

The work group has agreed on the short-term strategy, which involves the re-labeling of existing Canadian product to facilitate import by U.S. growers purchasing

it for their own use. While the focus is on developing a viable program for the spring

of 2007, a pilot chemical was selected to use as a case study this fall of 2006. The

case study of the proposed process has now been completed and we expect actual

importation, on a test basis, of the pilot chemical within the next few weeks.

U.S. growers have consolidated and prioritized a list of chemicals that they would

like to be able to access through the short-term program. That list will form the

basis for selecting chemicals for the import program in the spring of 2007. Registrants have thus far volunteered to participate in the import program for 5 chemicals on the list. We expect that more registrants will volunteer for the program once

they have had a chance to analyze the case study.

The long-term strategy focuses on developing joint labels for use in both the U.S.

and Canada that will be part of product packaging, facilitating free movement

across the border. Two options are currently being considered and registrants have

developed draft labels to illustrate these options. EPA, Canada’s Pest Management

Regulatory Agency (PMRA), and the registrants are working to finalize one of these

labels, which will serve as a template for others. Registrants have thus far volunteered three chemicals for development of the joint US/Canada labels and another

one is possible, pending resolution of trademark issues. Finally, EPA and PMRA

have proposed a process for new joint mechanisms for the label amendments and

review. We are very excited about this approach and its potential to address this

longstanding issue.

PESTICIDE REGISTRATION IMPROVEMENT ACT (PRIA)

I would now like to discuss EPA’s implementation of its statutory requirements,

beginning with the 2004 Pesticide Registration Improvement Act (PRIA). PRIA provides for the coupling of registrant fees with specific decision completion timeframes

for certain pesticide registration activities. Under PRIA, fees are collected from the

pesticide manufacturers for 90 different types of actions, ranging from a request to

register a new food use pesticide to various types of amendments to existing registrations. PRIA also reauthorized maintenance fees, which are providing $116 million over a five year period for reregistration and tolerance reassessment work at

EPA. These fees are critical to ensure stable funding for the review of older pesticides.

In response to the PRIA requirements, we have taken several steps to improve

the timeliness of our decisions. For example, we created a stakeholder advisory

group to provide advice on program efficiencies. Many actions, such as improving
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processing and screening of applications, are internal to the Agency. After we receive an application, we bring together appropriate staff to determine what specific

work is required and how to most efficiently complete that work. We encourage innovative approaches to streamline reviews and are investigating ways to reduce the

time needed for regulatory support work. Work is underway to determine how to

enhance work sharing with other regulatory authorities, such as Canada.

Looking forward, the Agency is exploring ways to enhance the use of information

technology to facilitate the registration application process and reduce review and

decision times. Our goal is to develop an interactive, web-based application system

that would guide an applicant through the application submission process and

would help identify mistakes and omissions as they are made. Initially, our focus

is on electronic review of labels and review of label changes. It is important to note

that, while we are actively seeking ways to improve review times, we will in no way

compromise the scientific quality of our assessments.

Since 2004, the Agency has received nearly 3,900 PRIA actions. For those actions

we have successfully met or exceeded the deadline 99.8 percent of the time. In some

cases, PRIA calls for decreases in decision timeframes during the life of the legislation. Where this has occurred, we have continued to meet the shorter timeframes.

PRIA implementation has provided new fee revenues, created a performancebased system to improve results, and has increased collaboration between the Agency and stakeholders. EPA will continue to work with the stakeholders to implement

PRIA, as well as provide technical assistance on any new or improved fees legislation for pesticide activities at EPA.

THE FOOD QUALITY PROTECTION ACT OF 1996

The Agency recently observed the tenth anniversary of the enactment of the Food

Quality Protection Act (FQPA). When Congress unanimously passed FQPA in 1996,

you presented EPA with the challenge of implementing the most comprehensive

overhaul of the nation’s pesticide and food safety laws in decades. This was a formidable task that led to a complete transformation in national pesticide regulation.

I believe the Agency and its public and private sector partners have been highly successful in carrying out the public health and environmental protections embodied in

FQPA.

TOLERANCE REASSESSMENT

The centerpiece of Congress’ challenge was the requirement to review and reassess the tolerances (maximum permitted residues) for all food-use pesticides within

a decade. I am proud to report that we have completed reassessments for more than

99 percent of the 9,721 subject tolerances. This complex scientific effort required the

detailed review of tens of thousands of studies and test results on toxicity, chemistry, and environmental data. Notably, this work resulted in the revocation or

modification of nearly 4,000 food tolerances.

The United States continues to set the bar for pesticide safety and we have raised

that bar. EPA’s pesticide standards significantly advance food safety, public health,

and environmental protection. This 10-year effort, based on sound science and broad

public participation, has resulted in more protective measures for all Americans, especially infants and children. We routinely consider the special susceptibility of infants and children to pesticide residues, and we conduct residential, drinking water,

and other non-occupational exposure assessments.

REREGISTRATION

These enhancements in our risk assessment process were carried out simultaneously and in concert with the effort to make determinations on the reregistration

of existing pesticides. That program resulted in the cancellation of nearly 4,400 individual pesticide end-use product registrations while still ensuring that safe pesticides are available to protect Americans, their homes, and their food supply.

The Agency has taken thousands of individual, protective actions, resulting in

enormous public health progress. For instance, the cumulative assessment of

organophosphates has resulted in numerous real world benefits. Nearly 1,700

organophosphate tolerances have been reassessed to meet the FQPA safety standards.

Of the 49 organophosphate pesticides (OPs) that were registered at the beginning

of the reregistration process, 17 have been voluntarily cancelled or are being phased

out. Virtually all residential uses of the remaining 32 OP’s have been eliminated.

By virtually eliminating use of OPs in residential settings, we have seen reported

incidences of unintentional OP poisonings decline by 70 percent. In addition to re-
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stricting general organophosphate pesticide use, the amount of these pesticides used

on children’s foods decreased from approximately 28 million pounds of active ingredient to approximately 12 million pounds between 1994 and 2004—a 57 percent reduction.

Equally crucial in achieving FQPA goals are the many new products and uses we

have registered. Over the past 10 years, EPA has registered 248 new active ingredients and more than 1,600 new uses of existing pesticides. Not only did all of these

decisions meet the strict safety standards of FQPA, but these new products provided

critical alternatives to many of the uses restricted or eliminated as part of the tolerance reassessment and reregistration programs. Without these newly registered

lower-risk alternatives, America’s shift to safer pesticides would not have been possible.

ENSURING SAFE AND EFFECTIVE TOOLS REMAIN AVAILABLE FOR AN ABUNDANT, AFFORDABLE AND HEALTHY FOOD SUPPLY

Equally important as FQPA’s statutory requirements was the innovative approach

reflected in EPA’s implementation. The Agency’s guiding principles have been to ensure that decisions are sound and science-based, that our implementation is open

and transparent, that actions are timely, and that public policies are sensible. Our

work to upgrade the national pesticide program has been guided by these principles

and they are embodied in our everyday work. As a result, we have ensured that safe

and effective pest management tools are always available to support production of

an abundant, affordable, and healthy food supply.

There were many critics who believed that implementation of FQPA would result

in the loss of long relied-upon pest control tools without viable alternatives. Instead,

the Agency has made a reasonable transition for pesticide users a cornerstone of its

implementation activities. Throughout the regulatory process, we communicate with

the user community to gather information on the benefits of pesticides and which

pesticides or pesticide uses are most critical—information that we consider when

making our regulatory decisions.

We have made tremendous progress in the registration of newer, safer chemistries

which have enabled growers to move away from older chemicals. We work closely

with our colleagues at the U.S. Department of Agriculture, university researchers,

and pesticide users to facilitate transition. Finally, activities such as the Pesticide

Environmental Stewardship Program and the Strategic Agricultural Initiative help

pesticide users interact with Agency personnel and work together to promote sustainable pesticide practices. We look forward to building on this sound foundation

to meet the remaining challenges in protecting human health and the natural environment and carrying out additional FQPA mandates.

REGISTRATION REVIEW

Notable among the remaining challenges in implementing FQPA is establishing

the Registration Review program, which Congress envisioned as the means to guarantee the ongoing stewardship of existing pesticides. Registration review is intended

to ensure that all pesticide registrations are systematically reviewed to determine

whether they continue to meet the statutory standard for registration. Our goal is

to have a seamless transition between reregistration and registration review.

To implement the program, EPA will announce a schedule for pesticides to be reviewed during the current year and at least the two subsequent years. We will assemble information we intend to consider in our review and provide that information for public review and comment. We will review the information and comments

to determine what has changed since the last regulatory action and how significant

those changes are.

Following that review, the Agency may decide there is no cause to amend the

original registration or reregistration decision or that a new risk assessment is

needed. If necessary, we will ask for additional data to conduct the new assessment.

At the end of the process, a decision document will be published indicating whether

a pesticide meets the requirements for registration and, if not, what steps must be

taken to ensure that it does.

As with reregistration and tolerance reassessment, the registration review program will be conducted in a manner that is based on sound science and provides

for public participation, transparency, and efficiency to protect public health and the

environment.

EPA continues to seek and create effective mechanisms for safeguarding our

health and environment while ensuring the continued availability of pest management tools. We continue to work to harmonize the availability of pesticide products

between the U.S. and Canada through the NAFTA pesticide working group. We are
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striving to improve our regulatory decision-making so that we continue to meet the

stringent PRIA deadlines. Finally, while EPA is proud of our accomplishments in

implementing FQPA, we realize that we must continue that momentum through

registration review.

While the Agency pursues these activities, we are ever mindful of our responsibility to protect human health and the environment. Our challenge is to continue

meeting this responsibility in a manner that uses the best available science, that

is open and transparent, and that recognizes the need to make sensible, timely decisions.

Thank you for the opportunity to discuss these matters. I look forward to working

with you, other Members of Congress, and other affected stakeholders on these important issues.
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STATEMENT OF JAY VROOM

Mr. Chairman and Members of the subcommittee: I am Jay Vroom, President of

CropLife America (CLA). CLA is a national trade association representing the manufacturers, distributors and formulators of virtually all crop protection chemicals

used in the United States. I appreciate the opportunity to testify before you today.

I want to begin by thanking Chairman Lucas and the entire subcommittee for

holding this important hearing and for your ongoing leadership and oversight on all

pesticide and crop technology issues. I was pleased to testify before the full House

Agriculture Committee just two weeks ago regarding how the Farm Bill impacts the

agricultural chemical industry. I specifically highlighted the tremendous contributions our industry makes toward conservation efforts, including soil, water, wildlife,

energy and labor conservation.

However, pesticide benefits represent only part of the story. There are a number

of policy challenges facing our industry that also merit our attention, including U.S./

Canada regulatory harmonization, Endangered Species Act (ESA) compliance, user

fees under the Pesticide Registration Improvement Act (PRIA), and National Pollutant Discharge Elimination System (NPDES) permitting under the Clean Water Act.

REGULATORY HARMONIZATION

Over the past decade, there has been a significant increase in the amount and

complexity of data needed to support registration of pesticides which has placed additional burdens on regulators as well as pesticide manufacturers. As a result, there

is a strong interest among regulators and industry alike to achieve international

harmonization of the registration processes for pesticide approval, with particular

attention being given to harmonizing the regulatory systems between the United

States and Canada.

Before granting registration for pesticides, both U.S. and Canadian regulatory authorities perform thorough assessments to ensure that unreasonable adverse effects

to human health and the environment will not result from approved uses. However,

these authorities regularly differ in the type of data required, the regulatory review

process itself and the time required for regulatory review and approval.

For example, the U.S. Environmental Protection Agency (EPA) may require submission of data on endangered species to support a particular use, while the Pest

Management Regulatory Agency (PMRA) in Canada would not. Conversely, Canada

reviews studies of the efficacy of agricultural pesticide products, while the U.S. does

not. These differences can contribute to the disparate costs of doing business in the

United States and Canada and affect the availability of certain crop protection products for use by farmers in both nations.

Equally challenging is the sheer number of pesticide products registered for use

in both countries. In 2004, there were 16,115 registered pesticide products containing 1,015 active ingredients in the U.S. and 5,274 registered pesticide products containing 525 registered active ingredients in Canada. Since 1997, more than 149 new

active pesticide ingredients and 2,489 new uses have been registered by the U.S.

EPA alone.

Several broad principles have been espoused by CLA as the United States and

Canada work toward regulatory harmonization. First, significant differences between the U.S. and Canadian copyright, patent and trademark laws must be considered before meaningful harmonization can be totally achieved. User safety, customs

regulations, and label harmonization differences will also need to be addressed as

part of harmonizing U.S. and Canadian pesticide regulation. In addition, CLA believes the proper forum to achieve harmonization of regulatory processes is under

NAFTA and that attempts to achieve reform on a state-by-state basis would be unworkable and counterproductive. Furthermore, harmonization between the U.S. and

Canada must reduce the time from submission of an application to a final registration decision and minimize any unnecessary duplication of testing. Harmonization

must also facilitate increased cooperation among regulatory officials in both countries in order to achieve the goals outlined by the crop protection industry. Lastly,

CLA supports harmonization of the pesticide registration process between the U.S.

and Canada because it would provide growers with equal access to products on both

sides of the border while contributing to the free trade of crop protection products

and treated commodities between the countries.

Because the lack of consistent and harmonized regulatory standards between the

two countries has slowed access to new products and new product uses, CLA believes that until these differences are resolved, crop protection companies will continue to struggle with meeting different demands for each system. Although the obstacles are formidable, CropLife America believes that focusing on key regulatory
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harmonization activities that are essential to both growers and registrants is a high

priority and should be addressed in the context of ongoing efforts to achieve full harmonization by various stakeholders.

EPA participates in a variety of international regulatory harmonization activities

related to pesticides, including the Organization for Economic Cooperation and Development (OECD). OECD carries on a continual process of review and revision of

international chemical testing guidelines, including residue chemistry and

ecotoxicology standards.

OECD has recently completed a major development of more than 80 electronic reporting formats for chemical regulatory studies. CLA has contributed substantially

to this effort through comments on the individual formats; however, significant additional effort will be required to practically implement the electronic formats by both

governments and industry. The ultimate benefits of the project include the ability

of registrants to format a study once for submission to any national regulatory authority; collaboration of national regulatory authorities on product approvals

through electronic exchange of study reports and reviews; and progress in international standardization of study reviews.

The Food and Agriculture Organization of the United Nations (FAO), in cooperation with the plant science industry, and other international organizations, including NGOs, developed a voluntary code of conduct, The International Code of Conduct on the Distribution and Use of Pesticides, to provide a standard for pesticide

regulation, especially useful for those countries that are works-in-progress developing their own adequate national regulatory infrastructures for pesticides. The original FAO Code was published in 1985 and updated in 1989 and again in 2002.

The Code addresses the need for a cooperative effort between governments of exporting and importing countries, as well as other stakeholders, to provide training

and promote practices which ensure safe and effective use of pesticides, including

the promotion of IPM. The Code also encourages stakeholders to participate in international agreements affecting pesticide distribution and use, including the Rotterdam Convention on Prior Informed Consent (PIC).

Lack of harmonized processes can have real impacts on growers, as differences

can affect availability and cost of products. In an August 2004 letter to the U.S.

EPA and Canada’s PMRA, the National Association of Wheat Growers and the

Grain Growers of Canada wrote to express ‘‘support for harmonized regulatory systems across the borders of our two countries. On behalf of farmers and crop protection registrants on both sides of the Canadian-U.S. border, we now write to further

encourage the development of a seamless joint registration process for crop protection products in the U.S. and Canada. We believe this approach will alleviate the

concerns of producers on both sides of the border who want more equitable availability of crop protection products, and will simplify the registration process for manufacturers, allowing them to complete reviews and product approvals more quickly

and economically.’’

The group that is perhaps doing the most intensive work on harmonization at the

present time is the NAFTA Technical Working Group on Pesticides (NAFTA TWG).

Formed in 1996, the NAFTA TWG consists of representatives from the pesticide regulatory agencies of the three NAFTA countries. The mission of NAFTA TWG is to

resolve pesticide registration issues affecting free trade of agricultural commodities

across North American borders.

Over the past several years, the NAFTA TWG has made progress in harmonizing

science-based test protocols and test guidelines requirements, such as identifying

what studies need to be conducted and submitted in the U.S. and Canada. However,

significant differences in the regulatory approval processes between the two regulatory authorities still exist. The most significant differences include the registration

review time for a new active ingredient; the ability of a registrant to amend a petition after submission; dietary risk assessment procedures; the required content of

the pesticide labels; procedures for establishing tolerances or maximum residue limits (MRLs); as well as processes for amending pesticide labels.

A subgroup of the NAFTA-TWG met in Indianapolis, Indiana earlier this month

to discuss two pilot projects that would potentially provide interim measures to address concerns of the grower groups. During the meeting, grower representatives

from both Canada and the U.S. had the opportunity to present a list of priority

products they want to see included in the existing Canadian own-use program and

a similar U.S. own-use pilot project being developed by EPA. In addition to the ownuse pilot, the NAFTA TWG is also considering a joint U.S./Canada label, where both

the U.S. and Canadian use directions would be included on the pesticide container.

A few CLA member companies have volunteered products for these trial programs.

There are many unanswered questions about both of the pilot projects; however, our

industry is committed to finding solutions that provide long-term benefit to the
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grower community while expediting real regulatory harmonization between the two

countries.

It should be mentioned that there are significant stewardship concerns that exist

with own-use importation (OUI) programs, and the existing Canadian law that establishes that country’s own-use import initiative has provided a number of negative, unintended consequences. The simple discrepancy of metric application rates

used in Canada and English units used in the U.S. could easily lead to serious application errors causing crop damage or loss of efficacy. Furthermore, Canada has

industry funded stewardship programs to recycle plastic containers and collect unused and unwanted product. The OUI in Canada allows products to bypass normal

distribution channels, so Canadian registrants and distributors often pay the stewardship costs for products they did not sell. For an OUI program to function fairly,

the Canadian pesticide industry is asking for the groups that import products to pay

the same stewardship fees that the traditional distributors would pay. We believe

that an operational U.S own-use pilot program would have to address similar stewardship concerns.

Regarding MRLs, Canada’s Pest Management Regulatory Agency sought comments this summer on its proposal to revoke the long-standing general limit for residues of pesticides that are not registered in Canada. Because of climatic and cropping differences, more pesticides are registered in the U.S. to treat a wider variety

of pest problems than exists in Canada. Thus, produce grown here may have residues that are not specifically approved in Canada. The default MRL of 0.1 ppm has

long taken care of many such circumstances, facilitating a vigorous trade in agricultural commodities between our two countries.

The Canadian proposal points out the need for progress towards mutual acceptance of MRLs established by either country. There should be no need for one country’s regulatory agency to spend time and resources to duplicate the valuable risk

assessment work already accomplished by competent scientists in the neighboring

country. EPA and PMRA are making significant strides toward these goals, and

should be encouraged and aided by Congress in their efforts.

Despite all of the challenges facing both registrants and the grower community,

there are success stories that demonstrate that solutions are possible. During the

1990’s, the crop protection industry worked through the NAFTA TWG and USDA’s

IR–4 Program to address product availability concerns from U.S. canola growers.

Since canola was comparatively new in the U.S. and the U.S.-planted acreage is considerably smaller than in Canada, U.S. growers were eager to gain access to crop

protection products which have already been registered across the border. Industry

responded within the course of a few short years by registering nearly a dozen new

pesticide uses for canola. The pressure for importing Canadian products diminished

once EPA and USDA worked together to expedite similar products registrations in

the U.S.

FQPA 10-YEAR DEADLINE

While EPA continues to make progress on harmonization efforts, the Agency certainly deserves recognition for its achievements under the Food Quality Protection

Act (FQPA) in reassessing pesticide residue tolerances by August 3, 2006.

EPA’s work over the past 10 years has resulted in the reassessment of some 9,700

residue tolerances. CLA and our members have worked with the Agency in the administration of FQPA, but we have on-going concerns with its implementation. Continuing political pressure has been directed at EPA to push FQPA beyond its original, science-based intent while growers, food companies and the crop protection industry have worked for a more reasoned regulatory policy.

During this 10-year process, many decisions that negatively affected pesticide

products were shaped by political pressures. Some of these matters are still open

today, such as the battle over the use of ethically produced human clinical and

worker exposure data in regulatory decisions. It is important that EPA applies

transparency and good science policy to allow statutory standards to be clearly applied to pesticide regulations.

Congress passed FQPA in 1996 and the act went into effect immediately. As a

result of the new law, better scientific methodology was developed and implemented,

such as reviews of the Environmental Fate model updates. Throughout the reassessment procedure, a wealth of valuable data was generated, including Market Basket

residue surveys, exposure data, crop profiles, biomonitoring information, and water

monitoring data. At the same time, risk assessment methodology was carried out

in a much more transparent fashion.

Industry developments during this period focused on bringing newer, more effective pesticides to the market. Through the Pesticide Registration Improvement Act
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(PRIA), industry fees allowed EPA to maintain and accelerate its pace on tolerance

reassessment and provide improved time lines and predictability for registration of

new pesticide products. PRIA will need to be reauthorized rather soon and we and

the rest of the registrant community stand ready to work with the House Agriculture Committee to accomplish this on a timely and informed basis.

As a result of FQPA and the efforts of EPA, the food chain, and the crop protection industry, Americans continue to reap benefits from a rigorous and thorough

regulatory program and to enjoy the safest food supply in the world.

PESTICIDE REGISTRATION IMPROVEMENT ACT

PRIA was enacted on January 23, 2004. It requires pesticide registrants and applicants to pay specific service fees to EPA for the registration applications that it

handles. This law also establishes specific timelines for EPA to accomplish the various registration actions and prohibits certain other user fees for pesticides.

The intent of the law is to provide additional resources for EPA’s registration efforts and a more predictable evaluation process. As enacted, PRIA will be effective

for five years and it continues the prohibition on the collection of pesticide registration fees (40 CFR Part 152.400), which has been in effect since FIFRA was amended

in 1988. PRIA also suspends collection of tolerance fees authorized by the Federal

Food Drug and Cosmetic Act (FFDCA) (40 CFR Part 180.33).

CLA has successfully helped lead an Industry Fees Coalition that includes eight

trade associations representing pesticide registrants and worked closely with environmental and labor groups in lobbying Congress for passage of PRIA, in defending

PRIA since its enactment, and in implementing PRIA with EPA.

In addition to the new registration service fees, PRIA retained and increased the

product maintenance fees that support reregistration and tolerance reassessment

under FQPA. Industry is projected to pay a total of more than $200 million over

a five year period. The registration service fees and increased maintenance fees

went into effect in the spring of 2004.

The amount of the pesticide registration service fees and the timetables for the

review periods vary somewhat from year to year to provide for phasing in the new

timelines. Since 1989, Federal budget proposals by various administrations have repeatedly sought to reinstate the original pesticide registration fees for new products

(40 CFR Part 152.400) through modification of FIFRA. For FY 2007, OMB has proposed in the President’s Budget increasing pesticide user fees from anticipated revenues of $31 million in PRIA and maintenance fees to a total of $87 million by increasing both PRIA and maintenance fees, reinstating tolerance fees and creating

a new ‘‘registration review fee.’’

Fortunately, Congress has repeatedly barred collection of these other fees and ignored Administration proposals to modify FIFRA and FFDCA accordingly. Proposals

for additional registration and tolerance fees would violate the spirit of the compromise that resulted in the passage of PRIA.

PRIA has been successful in improving the predictability and speed of the pesticide registration process, and CLA calls on Congress and specifically this committee to reauthorize this important law.

ENDANGERED SPECIES ACT

One of our industry’s most significant policy objectives is the modernization of the

Endangered Species Act (ESA). CLA supports practical, balanced and scientificallysound amendments to the ESA to make it effective in recovering and saving species

at risk. We believe Congress needs to amend the ESA to improve the availability

of new technology and crop protection products for species habitat recovery. A huge

step was taken last fall when the House passed H.R. 3824, the ‘‘Threatened and Endangered Species Recovery Act.’’ We call on the Senate to pass similar legislation.

When the ESA was enacted in 1973, there were 109 species listed for protection.

Today there are roughly 1,000 U.S. species listed as threatened or endangered,

nearly 300 species considered as ‘‘candidates’’ for listing, and nearly 4,000 ‘‘species

of concern.’’ The authorization for Federal funding of ESA activities expired on October 1, 1992, though the U.S. Congress has appropriated funds in each succeeding

year to keep the program active.

On August 5, 2004, following coordination with EPA and the United State Department of Agriculture (USDA), the Fish and Wildlife Service and the National Marine

Fisheries Service published a joint counterpart regulation, which streamlined the

interagency consultation process for endangered species risk assessments for pesticides. This new regulation intended to marry the effects analyses requirement of

ESA with the scientific-based, data-intensive environmental analyses required by

the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The need for such
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regulations had been highlighted by a string of ESA citizen suits alleging that EPA

failed to consult with FWS and NMFS when registering pesticides. The concerns

about current court decisions and threats of additional litigation have created piecemeal regulatory process, as well as unnecessary restrictions for pesticide products.

These lawsuits have cost taxpayers millions of dollars as EPA defends itself against

a process that does nothing to improve protections for endangered species. Just in

the Pacific Northwest states, USDA estimates that the impact of one of the major

ESA/pesticides court decisions on agriculture is approximately $583 million annually. There are approximately 10 similar lawsuit filings across the country. Furthermore, just last month, a Federal judge in Washington State found portions of the

ESA counterpart regulation to be invalid, thus increasing the uncertainty surrounding the pesticide registration process and threatening farmer’s access to important

crop protection products. Congressional action is needed so these products, which

are so critical for food and fiber production, will not be terminated or compromised

in the interim by further court orders or settlement agreements.

NPDES CLEAN WATER ACT PERMITS

In 1972, Congress enacted the Clean Water Act and amended FIFRA. The Clean

Water Act authorized EPA to protect the nation’s waterways by regulating discharges of large industrial operations and wastewater facilities through the National Pollutant Discharge Elimination System (NPDES). FIFRA provided EPA with

the authority to regulate the sale and use of pesticides through a comprehensive

registration and labeling protocol.

Although CWA and its NPDES permit requirements have been in effect for over

thirty years, no government agency has ever concluded that the application of pesticides in accordance with label directions requires an NPDES ‘‘point source’’ permit,

including aquatic mosquito and weed control, as well as terrestrial uses that may

result in incidental spray drift entering water. FIFRA already requires strict testing

of pesticides to ensure water quality and aquatic species preservation; therefore, an

NPDES permit for pesticide applications has always been considered unnecessary

and duplicative.

However, in March of 2001, the U.S. Ninth Circuit Court of Appeals ruled in

Headwaters, Inc. v. Talent Irrigation District that NPDES permits were required

for the use of aquatic herbicides to control weeds in waterways. In November 2002,

the Ninth Circuit ruled in League of Wilderness Defenders v. Forsgren that an airplane used for the application of moth control products in the forest canopy was a

‘‘point source’’ pollutant and therefore aerial spraying of pesticides required an

NPDES permit under the Clean Water Act. Other similar cases are pending, and

activist groups are now using this unfortunate precedent to threaten lawsuits

against American farmers who must make millions of pesticide applications every

year in order to maintain viable crops.

Furthermore, since NPDES permits were never intended to be used for pesticide

applications, Federal and state agencies are not prepared to handle the massive rise

in permit requests that would result from farmers who must spray regularly

throughout the growing season. In many states, obtaining an NPDES permit is very

costly, time consuming and bureaucratic. It is not practical to expect American

farmers to bear such a major expense and delay urgent applications in the event

of a fast developing pest infestation.

EPA has issued several interpretive statements over the past two years reiterating its position that NPDES permits are not required for pesticide applications directly to or near waters of the United States. A proposed rule is currently pending

at EPA, which would codify the agency’s position.

While EPA’s proposed rule is certainly a positive development, the agriculture industry believes that legislation is the surest way to remove the threat of lawsuits

against farmers. EPA has also acknowledged that a rule will not alleviate the threat

of litigation. Farmers, irrigators, mosquito abatement districts, fire fighters, Federal

and state agencies, pest control operators and foresters will all benefit if Congress

chooses to clarify current law. We commend Congressmen Butch Otter and Dennis

Cardoza and a total of 76 other bipartisan cosponsors for introducing H.R. 1749,

‘‘The Pest Management and Fire Suppression Flexibility Act.’’ We encourage Congress swiftly adopt this legislation to resolve this important issue.

HUMAN CLINICAL STUDIES

Understanding potential risks to people is usually based on tests performed with

laboratory animals. Decades of experience reviewing both animal and human studies, has demonstrated that animal data alone may provide an incomplete picture of

safety and risks. Since animals are not able to speak, they can not provide informa-
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tion to assess important subtle effects such as respiratory irritation that could occur

at very low exposure levels. Despite the scientific basis for human testing, for nearly

a decade there has been intense debate over whether EPA should rely on human

data for pesticide registrations.

In early December 2001, EPA sought council from the National Academy of

Science on the science and ethics of human testing and simultaneously announced

that the Agency would not consider or rely on human data while the Academy was

deliberating. CropLife America petitioned the U.S. Court of Appeals stating EPA’s

announcement to not rely on human data constituted a ‘‘rule’’ that was promulgated

in violation of the Administrative Procedures Act. The court agreed and directed the

EPA to reinstate its practice of accepting human studies unless and until the Agency lawfully promulgated a rule to change its practices.

In 2004 the National Academy of Science completed its work and published its

findings. The Academy acknowledged the potential benefits of human data and recommended that EPA establish a Human Studies Review Board (HSRB) to review

and to oversee the scientific and ethics issues surrounding Agency’s use of human

data.

In late 2005, EPA issued a proposed human studies rule that established the

Human Studies Review Board as a Federal Advisory Committee and described the

conditions under which the Agency would accept human data. In its proposed rule,

EPA had excluded occupational exposure studies. This made sense because occupational studies are different from clinical studies because they are conducted during

normal work activities guided by lawful pesticide labels. In its final rule however,

and without public comment, EPA decided to include occupational exposure studies.

This was a complete surprise to the pesticide industry because EPA had not sought

guidance on occupational exposure studies from the National Academy and the

Human Studies Review Board was not comprised of experts in these studies.

Furthermore, we question EPA’s decision requiring the HSRB to determine the

scientific validity of testing-—such a requirement is duplicative because that determination has already been made by EPA using a wide range of other stakeholder

and public input.

In the wake of the Review Board’s rejection of several exposure studies designed

according to existing Agency guidance, EPA is now awaiting review from yet another science advisory panel in 2007. This delay has halted the ability of the pesticide industry to collect occupational exposure data necessary to protect workers

and will likely result in further confusion and inconsistencies between the Human

Studies Review Board and the new Science Advisory Panel.

SOIL CONSERVATION

Herbicides have been used on more than 90 percent of US acreage of most crops

for the past forty years. The use of herbicides has greatly reduced soil erosion, decreased the need for millions of hours of difficult labor by workers in the field, and

has helped keep American agriculture competitive due to their low cost and high

degree of effectiveness. The performance bar is very high for herbicides. Farmers expect more than 95 percent season long control of all key weed species in their fields

with one or two applications and without injury to their crops. No other weed control technology is remotely close to delivering these benefits.

The USDA has reported that cropland soil erosion declined by 700 million tons

per year between 1982 and 2003. This reduction has coincided with adoption of

practices that conserve soil. No-till crop production, in which the soil is left undisturbed by tillage, is the most effective soil-conserving system. Elimination of tillage

means that the grower must rely on herbicides to control weeds. No-till acreage increased to 62 million acres in 2004.

The external costs of soil erosion include higher susceptibility to flood damage,

lost reservoir capacity, increased water treatment costs, and adverse impacts to waterway navigation and recreational activities. Research from the CropLife Foundation indicates that by reducing erosion from cropland, no-till reduces these external

losses by $1.5 billion per year. Of course, the farmer benefits too. With more soil

staying on his land, the farm remains more productive and profitable.

LABOR AND ENERGY CONSERVATION

The use of herbicides greatly reduces the need for both fuel and labor on U.S.

farms. Without herbicides, the need for fuel would increase by 337 million gallons,

since twice as many cultivation trips would be needed to replace herbicide spray

trips. Furthermore, cultivators use four times more fuel per trip than herbicide

sprayers.
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Herbicides also play a key role in U.S. ethanol production, a sector which is projected to expand to seven billion gallons in 2010. Corn is the primary raw material

for US ethanol production. On average, herbicides increase U.S. corn production by

20 percent. If corn growers were unable to use herbicides, the decline in corn production would be equivalent to the total projected ethanol capacity of seven billion

gallons.

If farmers did not use herbicides, the alternatives for weed control would be increased mechanical cultivation and increased hand labor to pull weeds. Research

from the CropLife Foundation indicates that a minimum of 1.1 billion hours of hand

labor would be required at peak season for hand weeding, necessitating the employment of seven million more agricultural workers. Even with the increased cultivation and hand weeding, crop yields would be 20 percent lower. Approximately 70

million workers would be needed to prevent any yield loss without herbicides.

Organic growers do not use herbicides to control weed populations, but rely on

mechanical cultivation and laborers with hoes instead. Growers of organic vegetable

crops spend close to $1,000 per acre for weed control in comparison to the $50 per

acre spent by growers who use herbicides. Each acre of organic vegetables requires

between 50 and 100 hours of hand labor for weed control. Each hour of labor is

budgeted at $10 which covers a minimum wage, plus administrative, supervisory,

transportation and benefit costs. It should come as no surprise that the production

of organic crops is being outsourced to countries such as Mexico and China where

the cost of farm labor is $1 per hour or less.

WATER CONSERVATION AND QUALITY

CropLife America’s member companies know that protecting water quality and

conserving scarce water resources in agriculture must often start in the laboratory,

where products are developed, tested, and evaluated. Their efforts start with using

the best science available to develop good products that can provide the needed results. This attitude and approach have led to major water conservation and water

quality benefits in the U.S. and worldwide.

One excellent strategy to successfully conserve scarce supplies of water for agricultural and other critical uses is to develop crop varieties that are uniquely adapted to drought and other forms of weather stress. Our member companies have created plant varieties that are drought resistant or tolerant, allowing a crop to be produced with less irrigation and thereby conserving scarce water resources. We have

also created plant varieties that have resulted in innovative crop production practices, like the use of pre-germinated rice seeds that require 15 to 20 percent less

total water to produce a crop relative to more traditional rice production practices.

Our science has also led to a crop protection product that can control weeds in rice

production that previously could only be controlled through flooding rice land, thereby avoiding the use of water that could be better dedicated to other critical purposes. Of course, all herbicides for all crops are designed to control weeds that would

otherwise compete with the crop for water.

Crop protection science and water quality protection go hand-in-hand. Over the

10-year process of developing and bringing a crop protection product to the market,

our companies ask three primary questions related to water quality considerations:

(1) Does the compound reach water and how?

(2) How does the compound behave if it reaches water?

(3) How does the compound affect water quality and impact living organisms?

Numerous rigorous scientific tests are conducted on a candidate compound and its

metabolites to answer these questions. We also use the same science to determine

if sound, reasonable and practical management strategies are available to ensure

that the products can be used without unreasonable adverse water quality risks.

The studies conducted involve identifying the compound’s decomposition pathways

within different crops, soils and water circumstances. Once the degradation patterns

have been established, analysis methods are developed for measuring residues.

Other studies analyze the effects of the compound and its major metabolites on

living organisms such as non-target insects, birds, soil and aquatic animals, and soil

micro-organisms. Such trials are run not only during product development but also

after their market launch. In fact, products are subject to continued monitoring and

re-evaluation, taking into account the latest state of the art developments. As far

as aquatic organisms are concerned, compounds are tested not only on fish, but also

on algae and water-fleas. Overall great efforts are made to constantly improve the

testing methods for the protection of even the smallest organism in natural water

bodies.

Our companies are also continuously engaged in research and development to find

ways to minimize the amount of water needed to spray crop protection products
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while maintaining their efficiency and efficacy. New spray nozzles, for example, can

reduce water consumption by approximately 80 percent, from 530 gallons per acre

to 105 gallons. The use of low volume water-based sprays combined with application

nozzles that target each crop row can decrease water use by 95 percent or more,

from 210 gallons of water per acre to only 7 or 8.

Even after our products reach the market and are being used in the field, our

member companies continue to pursue innovative and practical crop protection product management strategies. We have been leaders in the marketing and use of

streamside buffer zones and filter strips as a way to improve water quality, reduce

soil erosion, and increase wildlife habitat.

Likewise, our products also help conserve water in non-agricultural settings. One

critical example is their use as part of an integrated program to control noxious and

invasive plant species. For example, the salt cedar tree was originally introduced

into the U.S. from Central Asia to combat soil erosion near rivers and lakes. But

salt cedar is often able to thoroughly out-compete native plant species and in the

process transpire enormous quantities of ground water into the atmosphere in arid

environments. One mature salt cedar plant may withdraw up to 198 gallons of

water per day. Where these trees have become established, they lower water levels

in rivers, streams, and groundwater tables, reducing water supplies for urban, agricultural, wildlife and recreational uses. Crop protection products have been used in

public initiatives as part of an overall management strategy in key areas of the U.S.

to control salt cedar. In one prominent project in Texas and New Mexico, control

of salt cedar with herbicides has resulted in an estimated increase of over 15 billion

gallons of river flow during a year long season.

Our aquatic products also preserve and protect water quality through the elimination or control of noxious or exotic aquatic plant species in rivers, streams, lakes

and estuaries. Like salt cedar, these alien invasive plants out-compete the native

aquatic plants, and in the process diminish or eliminate plant biodiversity and degrade or destroy fish habitat. These invasive aquatic plants include species like Eurasian water milfoil, water hyacinth, hydrilla, purple loosestrife and Melaleucca.

Used as part of an overall aquatic invasive plant management strategy, aquatic herbicides can selectively control populations of invasive plants and support the restoration of native plant communities and quality aquatic wildlife habitat. Control

of these invasive plants can have substantial water conservation benefits because

their sheer mass can impede or stop the flow of water and increase rates of evaporation and other pathways of water loss that would otherwise be used for irrigation.

WILDLIFE CONSERVATION

One often over-looked contribution that pesticides make is in the area of wildlife

habitat restoration and conservation. Conservation scientists rank habitat destruction and nuisance plants as the two most serious threats to endangered species,

both plant and animal. Many of our pesticides provide significant benefits for endangered species by reducing the amount of land needed to produce crops, thereby preserving critical wildlife habitat.

Equally important, pesticides increase the diversity and quality of natural habitat

through the effective control of non-native or nuisance plants that seriously threaten

endangered species as well as damage lakes and streams, farms and natural areas.

Two years ago, CropLife joined forces with one of the country’s leading conservation organizations, Ducks Unlimited (DU), and established a Conservation/Technology Initiative. This unique partnership harnessed the power of crop science technology in conjunction with wildlife biologists’ expertise to reduce the abundance of

unwanted exotic grasses and other weeds at wildlife refuges and other sites where

DU seeks to restore native grasslands. The key here is to use herbicides and fungicides to suppress the weed growth long enough for native grasses to reestablish

themselves. Because many native plants are perennials, once reestablished, they

can flourish for decades under proper management.

This initiative also conducted a demonstration pilot project to show how the use

of certain pesticides could enable farmers to economically switch to winter wheat

from spring wheat in the northern plains-again to the benefit of duck populations.

CropLife member companies are in the second year of this five-year partnership

with DU and the results are already very encouraging. Habitat restoration is well

underway at 20 sites nationwide, and the benefits to waterfowl and other wildlife

are being recorded. Beyond the contributions being realized for wildlife conservation

efforts, these projects are also having a beneficial ripple effect for outdoor enthusiasts. At a number of the areas, control of nuisance plants and weeds is helping

aquaculture, water-related recreational activities, hunting and fishing, bird watching and natural scenic restoration.
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ECONOMIC BENEFITS OF PESTICIDES

Fungal pathogens are implacable enemies of crop production in the United States.

Every spring and summer, fungi release countless numbers of reproductive spores

into the environment. If a spore lands on a susceptible host plant under the right

conditions, it will grow a germ tube and penetrate the host plant’s tissues. The resulting fungal infection will cause the plant to fall ill, rot, and eventually die. The

use of fungicides to protect crops can prevent or cure such infections, preserve crop

yields, and protect farmers’ income.

Uncontrolled plant disease epidemics have altered human history, determining

the outcome of wars, starving millions of people, and contributing to the decline of

civilizations. The unavailability of fungicides left farmers and their dependent civilizations defenseless against plant diseases.

Prior to the 20th century, much of the nation’s fruit and vegetable crop typically

rotted following infection by plant diseases. In the early 1900’s, elemental fungicides

provided defense against many fungal diseases as copper and sulfur sprays became

common. Most fruit and vegetable crops have been treated with fungicides for the

100 years since initial adoption.

The introduction of synthetic fungicides in the 1940’s revolutionized chemical control of plant disease. Newly discovered fungicidal molecules were rapidly adopted by

U.S. farmers for their expanded range of disease control and reduced toxicity to crop

plants. The replacement of many sulfur and copper sprays with synthetic fungicides,

which are used at significantly lower rates, reduced the aggregate total amount of

fungicides applied to U.S. crops by 50 percent.

The Crop Protection Research Institute (CPRI), an arm of the CropLife Foundation, recently concluded a major study on fungicide benefits in the U.S. For 231 diseases of 50 crops, fungicides are the primary means of defense from fungi. Each

year, American growers spray 108 million pounds of fungicides at a total cost of

$880 million. If left untreated, yields of most fruit and vegetable crops would decline

by 50 percent to 95 percent. Growers gain $12.8 billion in increased production

value from the control of plant diseases with fungicides.

CPRI has done similar research on herbicide benefits. U.S. farmers have sprayed

herbicides on close to 90 percent of the nation’s cropland acreage for the past thirty

years. The value of the use of herbicides in 2005 is estimated to have been $16 billion in increased crop yields and $10 billion in reduced weed control costs. Without

herbicides, the largest production loss would be in corn, with a reduction of 2.7 billion bushels.

Increased fuel and labor costs have made the costs of alternatives to herbicides

higher. The aggregate cost of cultivation and hand weeding as replacements for herbicides increased from $14.3 billion in 2001 to $16.8 billion in 2005, resulting in a

net increase in weed control costs without herbicides from $7.7 billion in 2001 to

$10 billion in 2005. The value of the crops also increased significantly between 2001

and 2005, which means the 20 percent loss in production without herbicides is

worth more in 2005 ($16 billion) than in 2001 ($13 billion). Overall, the value of

herbicides to U.S. agricultural production increased from $21 billion in 2001 to $26

billion in 2005.

Three trends that occurred in crop production and weed control between 2001 and

2005 are noteworthy, relating to no-till, biotech, and organic crop production. Two

of these practices are dependent on herbicides and one is not. The number of notill acres on which herbicides substitute for tillage increased from 52 million acres

to 62 million acres. The U.S. acreage planted with genetically modified herbicidetolerant crops increased from 66 million acres to 94 million acres. Meanwhile, organic agricultural production increased by 100,000 acres to 1.4 million acres. Organic farmers substitute labor and tillage for herbicides, which is very costly. There

is not likely to be a vast expansion in domestic organic acreage due to the high cost

of labor in the U.S. in comparison to many developing countries.

Mr. Chairman, thank you again for the opportunity to share our views with the

committee.

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