Pesticide Program Dialogue Committee Meeting
Georgetown University Conference Center
The Leavey Center (Salons G & D)
3800 Reservoir Road, NW
May 9 - 10, 2002
Marcia Mulkey Director, Office of Pesticide Programs,
Jim Jones, Deputy Director, Office of Pesticide Programs, EPA
Anne Lindsay Director, Field and External Affairs Division, EPA
Peter Caulkins, Associate Director, Registration Division, EPA
Arnold Layne, Acting Associate Division Director, Services and
Resources Division, EPA
Margie Fehrenbach, Designated Federal Official, EPA
Lori Berger, California Minor Crops Council
Pat Quinn, Accord Group
Jennifer Popowitz, Proctor & Gamble Company
Bob Rosenberg, National Pest Management Association
Shelley Davis, Farm Worker Justice Fund
Bob Holm, IR-4 Program
Bill Tracy, National Cotton Council
Carolyn Brickey, Institute for Environment and Agriculture
Phil Benedict, Vermont Department of Agriculture, Food Markets
Larry Elworth, Center for Agricultural Partnerships Lori Harder
York Tribal Pesticide Program Council
Win Hock, American Association of Pesticide Safety Educators
Adam Goldberg, Consumers Union
Julie Spagnoli Bayer Corporation
Steve Balling, Del Monte Foods
Edward Zuroweste, Migrant Clinicians Network
Dan Botts, Florida Fruit & Vegetable Association
Alan Lockwood, Physicians for Social Responsibility
Has Shah, American Chemistry Council
Kristina Thayer, World Wildlife Fund
Jay Vroom, Crop Life America
Gary Libman, Emerald Bio Agriculture
Troy Seidel, People for the Ethical Treatment of Animals
Beth Carroll, Syngenta Crop Protection
Allen James, Responsible Industry for a Sound Environment
Warren Stickle, Chemical Producers & Distributors Association
Bill McCormick, Clorox
Nancy Lewis, University of Nebraska
Melody Kawamoto, Centers for Disease Control and Prevention, National
Institute for Occupation, Safety and Health
Terry Troxell, Food and Drug Administration, Center for Food Safety
and Applied Nutrition
Al Jennings, USDA
Debbie Edwards, Acting Director, Registration Division, EPA
May 9, 2002
MS. MULKEY: Thanks for being here to do this
work together today. We are delighted to see you all. We're
very pleased at the attendance, and it is, believe me, better
than it looks like this moment. We have an expectation of
a very full attendance of this hard working group.Our real
opening ceremony, if you will, is going to happen in just
a few minutes, because Adam Sharp and Burleson Smith have
agreed to kick us off with some remarks. And we'll do that.
I wanted to spend just a few minutes reviewing the day and
talking through a little bit about the committee and the philosophy.
We'll come back to some of those topics. We are working very
hard to make this committee more user friendly, more effective
and more interactive, and we've implemented some small and
some not so small efforts towards that end. One effort is
that we have worked on -- and we started this at the last
meeting -- sort of spreading the duties of the Chair within
EPA. And as you will see, we have -- each segment has a chair,
and for the most part that person is not I. In fact, the segment
this morning that shows me as the segment Chair, the Updates
in a Minute, was intended to be Jim Jones, Deputy Office Director
-- but we discovered that one of us had to be somewhere else
this morning and he drew the straw. So Jim will be at an undisclosed
location for the morning, and I will try to chair that session
along with the updates that he had planned to be responsible
for. But as you see throughout the rest of the program, we
have asked folks who are closer to the subject to work with
you, and we hope that builds relationships between you and
our key leadership team. So that's part of the reason for
that. Second and perhaps more importantly in terms of things
we're trying to do with the way we do business, is we are
attempting to work through a relatively finite number of topics
that we believe are important to us, and which we have some
indication are important to at least some of you, and to do
so in a way that really taps into what you have to contribute
to the topic.
So we've asked folks among you to actually participate in
presentations relating to those topics. We've asked you to
prepare for and in a more structured way participate in panels
around the dialogue for those topics. And we're hoping that
all of that leads to everybody's capacity to participate meaningfully
on each of those topics. So that's another thing that we work
for.The third thing we've attempted to do is build our agenda
in significant part around issues in which you show an interest
and to avoid agenda building in areas where you don't think
it's a productive way to spend your time, although obviously
we're mindful of our needs and interests as well.There are
many topics in which some of you are interested in some measure
of dialogue. For those topics where we cannot or should not
for some reason -- and we would try to explain that where
appropriate -- develop a more comprehensive dialogue around
the topic, we have tried to be sure that we at least provide
basic information on the topics. And that's the idea behind
a series of Updates in a Minute.
Many of those are topics where there is either some other
forum for stakeholder involvement or they're not exactly ripe
right now. In a couple of cases, they're in litigation. But
for whatever reason they're not well suited to a full dialogue,
but we want to meet your needs and ours for an information
flow. And so that's the idea behind that, and leaving then
some topics for needier and fuller development.We have also
implemented now our electronic -- PPDC forum, and we have
found that very useful. And many of you are actively participating
in that, and that, I think, develops a way for you to understand
each other's perspectives as well as for us to have a continuing
dialogue with you. And we are working -- we're looking forward
to your feedback as to how well that is working as a means
of continuing our dialogue. And finally, we are receptive
to other developments involving this committee to make the
dialogue more meaningful. So we look forward to your feedback
I wanted to just spend a little time on that overview. And
now I think we've got pretty much as full a seating as we're
going to get, and so it's my pleasure to turn the microphone
over actually to two key people. Adam Sharp has joined EPA
since we last met in the Office of Prevention, Pesticides
and Toxic Substances as a Senior Political Advisor. He is,
other than the presidentially-appointed Assistant Administrator,
the senior person and political person in our AA-ship and
provides in that role the kind of leadership that we all need
in a participatory democracy in which the Executive Branch
moves through the political cycle and has political leadership.
In addition, and at least as importantly, Adam brings to us
significant expertise and experience especially in agriculture,
and he brings that to the whole agency, not just to our AA-ship.
And as a result, he adds to our ability -- the political leadership's
ability -- to work through agricultural issues.
So it's really a pleasure to have him. I think he is -- he
insists that his head is not spinning, so he's obviously a
very quick study, because the depth, scope, breadth and challenges
of the issues with which we're working remains, as you all
are well aware, substantial. And then Adam has told me that
he will give Burleson a proper introduction, but I want to
say that we're also very pleased at this committee to have
Burleson Smith, who has newly joined the Department of Agriculture,
again, as part of their senior political leadership team.
And he also has agreed to make some opening remarks.Adam?
MR. SHARP: Thanks, Marcia. My head definitely
is spinning. That's for sure. But, you know, I don't know
how anybody could actually come into one of these political
positions and start cold without knowing something about the
issues that they're going to be dealing with.
And I guess from that standpoint, at least, I do feel fortunate,
because having a background in agriculture and dealing with
many of the issues that you're going to be discussing over
the next couple of days, and also many of the issues that
are going to be kind of at the forefront of the program's
challenges over the next couple of years, it's nice to be
able to say that coming in I have a little bit of groundwork
in these areas. And that helps a lot.Also what helps a lot,
is that I look around the room and I think I know most of
the people at the table. There are very few of you that I
don't know. So I look forward to continue to work with most
of you -- and all of you. We haven't filled all of the seats
yet. But all of you who are sitting here at the table that
I do know, and then for those of you who I don't, I look forward
to getting to know you over the next couple of days. It is
a very full couple of days' agenda, but I'm sure there is
going to be some very good discussions. Let me talk a little
bit about a couple of the issues that you're going to be discussing
over the next two days and just make some real brief comments
on those. Biopesticides, of course, is one of those, and I
think that's on the agenda for later this afternoon -- or
actually through the morning session and into the early afternoon
Biopesticides. There have been some challenges there, as many
of you know, as we move into kind of a post-FQPA era, which
is interesting to say, because we're still kind of in the
midst of FQPA, of course. But as we move into that era, we're
going to be looking for more reliance probably on reduced
risk products. Biopesticides can fill that nitch. Of course,
they've had a number of challenges, and we're going to be
discussing those and looking for your advice on those topics.
Section 18 process. As many of you know, I think the Section
18 process has worked wonderfully. And, of course, I'm actually
happy to talk about this past year's performance, in that
the granting of Section 18's was actually back to a pace that
was better than even prior to FQPA passage. So that's good
news for the program. It speaks well to the Section 18 process.
Of course, you can always improve good programs, and that's
what we're looking for today. And actually I think tomorrow
morning we're going to discuss Section 18's and get ideas
from you all and what we can do to further bolster the Section
The last issue I want to talk about is pesticide misuse. Pesticide
misuse is another issue we're going to be talking about tomorrow.
And this is a very important one. This is one that does have
a lot of challenges. I think we can also come up with a lot
of good solutions for dealing with some of these issues. There
is going to be, I believe, two panels that are going to discuss
not only the topic and some of the situations that have unrolled
over the last year or so. But also then we're going to talk
about some of the ideas that you have for what the agency
can do to address these issues. So with that, I look forward
to hearing what you have to say over the next couple of days.
And I'm going to turn it over to Burleson Smith here, but
I have to say something real quick about Burleson. Burleson
and I -- and this is the second time that we've sat at a table
together since we both started our new jobs.
I have to say it's a pleasure to be at this table versus the
one we were at about two months ago. Burleson and I and a
few of you in the room had the pleasure of travelling to northwest
Ohio to Bolling Green to testify at an FQPA field hearing
in a blizzard. And after that terrific experience, we of course
-- well, during that terrific experience we had the pleasure
of sitting at that table and testifying before the Commerce
committee folks, and I, of course, had been on the job a full
three weeks. Burleson had been on the job a full week. So
we dazzled them with our knowledge and expertise of the program
and returned back to Washington, D.C., hopeful that the next
field hearing on FQPA will take place in a nicer state in
the winter, like California or Florida. But nevertheless,
it was a good hearing and a good process. But I look forward
to your comments over the next couple of days. I'm going to
apologize actually for myself this afternoon. I'm going to
have to step out for the second half of today. I'll be back
again tomorrow, though. I have to sit in on a few meetings
for Steve Johnson. Steve does send his regrets as well. He
has to testify this afternoon on the Senate side at a POPS
hearing, so he's preparing for the hearing, as I know at least
one other individual, and maybe a few others in the room,
are also going to be testifying. So there are a couple of
events going on here, of course, today that we're trying to
spread our time amongst.
But I look forward to hearing what you have to say. And with
that, I'm going to turn it over to Burleson Smith with USDA.
MR. SMITH: Adam, thank you. As he said, I'm
Burleson Smith, and I am Special Assistant USDA. I had almost
forgotten about the hearing -- thanks for bringing it back
up -- in Ohio. In fact, before that meeting I thought white
out was actually an office product. But after driving through
the blizzards up there, I found out it's something else. As
Adam mentioned, I came aboard about two months ago shortly
after the last CARAT meeting, so in this respect it's the
first official meeting that I've had a chance to sit in. And
I certainly welcome all of you and appreciate your participation
As a newcomer to the process here, I certainly am looking
forward to the presentations today and tomorrow, especially
from a personal standpoint looking at the progress on the
cumulative risk assessments. Because for the most part, at
the department we hear a lot from growers these days, and
there is a fairly continuous line of questions wanting to
understand and anticipate what is going to happen. Certainly
I know that as this process is developing, some of those answers
are not yet available. But we have a very strong interest
in looking at what the alternatives may be as this process
works its way through, and what the impacts are going to be
on such programs such as management. So these are all areas
that within the department we are working closely, trying
to work with our colleagues at EPA and understand in advance
where some of these will end up. We also expect to work with
EPA to tailor the outcome on many of these decisions that
they're coming up with, so that we meet the objectives of
the Food Quality Protection Act, while also considering the
needs of many of the crop entities.
On another matter, one of the other presentations I'm certainly
looking forward to is the area of biopesticides. My background
of having worked with Ag Chem and fertilizer dealers, also
fertilizer and agri-chemical manufacturers, I have had some
experience working specifically with biopesticides. And so
I'm interested in hearing the panel's discussions and their
views today on the adoption of these products. I found it
very personally challenging to see how these products work,
particularly looking at the challenge between delivering a
balance between their performance under typical use conditions,
as well as looking for economical treatments. So it is an
area that certainly offers promise, but is an area that has
many challenges as well. So I look forward to those views.
I really would like to thank again the Office of Pesticide
Programs for the invitation to join you today. As Adam mentioned,
I will also be here this morning and then I'm afraid I will
have to step out for the afternoon. But I look forward to
joining you again for tomorrow morning. So, again, thank you,
Marcia, for the opportunity to be here today, and I look forward
to a very productive meeting.
MS. MULKEY: Well, thank you both. I think that
probably everybody on this committee was eager to get to know
both of you and are glad to have heard some of your perspective.
And we'll welcome any participation you want to share with
us as we go through the morning.
It seems like a good time now to have everybody introduce
himself or herself to you, if to no one else. Although I know
many -- you know many of these folks as well and to each other.
We have a very strong public attendance today, too, so it's
very -- it's neat to see that. I wanted to add that Steve
is going to make an attempt, notwithstanding his daunting
schedule, to find some social window time. And when he hears
about how good the food is over here, that may help. But,
you know, either at the end of the day, or maybe at lunch,
or as we break tomorrow, or even first thing in the morning.
So I don't know whether he will succeed, but I know he's really
trying to do that. Well, let's spend a few minutes saying
who we are. I'm Marcia Mulkey, Director, Office of Pesticide
MR. JONES: I'm Jim Jones, the Deputy Director of the Office
of Pesticide Programs.
MS. LINDSAY: Anne Lindsay, Director of Field and External
MR. CAULKINS: Peter Caulkins, Associate Director for
the Registration Division.
MR. LAYNE: Good morning. Arnold Layne, acting Associate
Division Director for Services and Resources Division. It's
been week number three for me, so forgive me. I'm also the
Public Health Coordinator for the program.
MS. FEHRENBACH: Margie Fehrenbach. I am the Designated
Federal Official for the PPDC, and I'm also a special assistant
MS.BERGER: Lori Berger, California Minor Crops
MR. QUINN: I'm Pat Quinn with the Accord Group, a government
relations firm here in Washington.
MS. POPOWITZ: Jennifer Popowitz with the Proctor
& Gamble Company.
MR. ROSENBERG: Bob Rosenberg with the National
Pest Management Association.
MS. DAVIS: Shelley Davis, Farm Worker Justice
MR. HOLM: Bob Holm, IR-4 Program.
MR. TRACY: Bill Tracy, California rancher, representing
the National Cotton Council.
MS. BRICKEY: Carolyn Brickey, Institute for Environment
MR. BENEDICT: Phil Benedict from the Department
of Agriculture, Food Markets.
MR. ELWORTH: Larry Elworth, Center for Ag Partnerships.
And I would like Arnold to repeat his job title.
MS. HARDER: Lori Harder, York Tribal Pesticide
MR. HOCK: Win Hock, American Association of Pesticide
MR. GOLDBERG: Adam Goldberg, Consumers Union.
MS. SPAGNOLI: Julie Spagnoli, Bayer Corporation.
MR. BALLING: Steve Balling, Del Monte Foods.
DR. ZUROWESTE: Edward Zuroweste, the Migrant Clinicians
MR. BOTTS: Dan Botts, the Florida Fruit &
DR. LOCKWOOD: Alan Lockwood. I'm a neurologist
and a representative of Physicians for Social Responsibility.
MR. SHAH: Has Shah, American Chemistry Council.
MS. THAYER: Kristina Thayer, World Wildlife Fund.
MR. VROOM: I'm Jay Vroom with Crop Life America.
And I can't believe that we've gotten all this way around
the table and nobody has said this, so I'm compelled to. Make
the observation that I'm now getting to be relieved to realize
that you were speaking figuratively about Adam's head spinning
being here on the Georgetown campus.
MS. MULKEY: Oh, dear.
MR. LIBMAN: I am Gary Libman, Emerald Bio Agriculture.
MR. SEIDEL: Hi. Troy Seidel, People for the Ethical
Treatment of Animals.
MS. CARROLL: Beth Carroll with Syngenta Crop
MR. JAMES: Allen James with Responsible Industry for
a Sound Environment.
MR. STICKLE: Warren Stickle with the Chemical
Producers & Distributors Association.
MR. MCCORMICK: Bill McCormick, Clorox.
MS. LEWIS: Nancy Lewis from the University of Nebraska
in the nutrition area.
MS. KAWAMOTO: Melody Kawamoto. I'm from the
Centers for Disease Control and Prevention, National Institute
for Occupation, Safety and Health.
MR. TROXELL: Terry Troxell, Food and Drug Administration,
Center for Food Safety and Applied Nutrition.
MR. JENNINGS: And Al Jennings, USDA.
MS. MULKEY: Oh, and we have several key EPA
folks behind us. Is there a mic back there? Well, we'll introduce
them as they appear. But I did want to take a minute to introduce
Debbie Edwards, who is the newly acting Director of our Registration
Division. Debbie, if you would stand up. I think a lot of
folks know you, but from other roles.
Well, it's time to go to work. The first set of topics we
have here are basically that we recognize that you -- oh,
I need to back up. I should have mentioned that there are
a handful of you -- and actually quite a small number -- who
are here substituting for the regular member. And so if you
saw some faces you didn't recognize, in all likelihood that's
what was happening. We'll try to identify that if it's necessary
a little later. But we have most of the actual principals
here with us today. This set of topics we spent some significant
time on at our last PPDC meeting. And one of the things you've
told us is that you would like a little bit more continuity
around topics. A little bit more sense of what we've done
or what's happened, or how we reacted to what we learned last
time. And so this is an effort to provide some continuity
around the topics that we've invested in previously. And these
are intended to be short updates, where the issue has evolved
since we last met.
My experience in government is in some ways, if you go away
for a month, say, in some ways you come back and feel as if
nothing has changed, and in other ways it's just like, oh,
you know, what happened here. So I think you'll feel a little
bit of both of those feelings. One is that, oh, that's exactly
where we last talked. And then you'll begin to realize that
things -- especially as you begin to look over a little bit
longer time frame, that there has been some real maturation
of issues. So with that in mind, you'll remember we discussed
two aspects of inerts: the disclosure work group and the whole
issue involving our risk assessment methodology. And Anne
Lindsay, Director of Field and External Affairs Division,
is going to give us an update on both aspects of that.
MS. LINDSAY: Okay. I had this moment of horror when
I looked at the actual words of the agenda this morning, because
when I did, it looked as if we had decided to combine the
issue of inerts disclosure with risk assessment methodology.
And to me, that seems like a very volatile mix. So the first
thing I want to assure you is I'm really talking about two
things. And then the other thing, I looked at it and I thought,
oh, it sounds like this is very passive, lifeless. In other
words, an inert set of activities. And that's not true, either.
This whole area -- actually I think there has been quite a
bit that has been accomplished since December.
In the December meeting, you were actually, I think, briefed
extensively, both on the work of the inerts disclosure stakeholder
work group, and you had a copy of what we were calling their
interim report, and you also had, I think, a very extensive
briefing from the agency on where we were with the methodology
development for inert ingredients. Both of those activities
have now reached sort of a major milestone. In April -- April
23rd, to be exact -- the inerts disclosure stakeholder work
group issued its final report. In many respects, it's quite
similar to what you saw in December. It has a first section
that just sort of describes its basic charter, mandate process
and identifies the principal audiences for better improved
information about inert ingredients. A second section that
deals with the proposals that the individual members of the
group developed for improving disclosure. A third section
which was a whole series of discussion and information papers
that the group developed in the course of educating itself.
And then the newest piece is actually what is listed as Appendix
And so I think you all -- Margie actually sent you copies
of the report in advance of the meeting. And Appendix A, I
think, is actually a very good summary of what I'll call two
principal perspectives on the topics and sub-topics related
to inerts disclosure. I'm not going to go through them. But
there were two groups of people from the full work group who
spent significant time putting the two pieces that are in
Appendix A together, and I think they represent a very good
summary of both the issues and the different perspectives
on those issues that the group had to contend with.
At this point, since you basically accepted the work group's
report in December, and simply urged the group to finalize
the report and complete their work, the group is officially
sort of de-commissioned. It has done its job. You've got the
report. And I think that the ball is now actually in our court
at EPA to take a look at all of this material -- and actually
we have been taking a look at it. It's not that we've been
silent partners in the process. And develop some proposals,
which I would expect at some future PPDC meeting might be
a topic for discussion with you and your advice and input
as to where we think we might go on the topic of disclosure.
On methodology, just a short reminder. We started working
on this methodology in order to really be able to accommodate
the requirements of FQPA as they applied to inert ingredients
in pesticide products. And also, frankly, to really improve
the effectiveness and the efficiency of our internal review
process so that we could make ourselves more productive. It's
a policy. Or not a policy, actually. A guidance document that
is evolved from the documents that we put out in '87 and '89
trying to articulate where we were with inert ingredients.
It is based on a belief, a scientific judgment that for many
of these inert ingredients they are of low or moderate toxicity.
The safety finding that FQPA requires can credibly be made
with significantly fewer data than we might have for a chemical
that was of higher potential toxicity.
So the paper which is actually in your packet explains the
evaluation process that we're actually now using for chemicals
that are of this low or moderate toxicity. We're making chemical
by chemical decisions with it. It's got a screening approach,
which you heard described to you at the December meeting.
And using basically the process outlined in this document,
we have made, as I understand it, two tolerance exemption
decisions for new exemptions, and also 200 plus tolerance
reassessments. So it's guidance. How we actually apply it
in any given case may be modified from what you see in the
paper itself to fit the particular circumstances associated
with an inert ingredient. And we also are open for comment
on it, and I think if I understood Pete correctly, the document
-- there may be a Federal Register notice issued shortly that
will specifically invite comment on the methodology. So you've
got sort of a pre-Federal Register notice copy of the methodology,
but it's -- it's it and it's in use. So that's it for inerts.
MS. MULKEY: Okay. Pete, I'm going to make a
little minor timing change here. Jeff Kempter, as it happens,
was unable to make it and Jim Jones is going to deal with
the anthrax issues. But for timing reasons, he needs to go
next and then we'll come to you, Pete.
MR. JONES: Thanks, Marcia. As many of
you, I am sure, recall, Jeff gave a -- Jeff and Michelle Wingfield,
actually, from the Antimicrobials Division talked at out last
meeting about the kinds of activities we're involved in as
it relates to anthrax decontamination and registration.
Since that time, a fair amount has happened on both the decontamination
front as well as the issues surrounding registration. We have
at this point, working with our colleagues in the Office of
Solid Waste and Emergency Response, as well as other federal
colleagues from the Postal Service to the FBI to the State
Department, issued a total of 13 emergency exemptions for
antimicrobial pesticides to decontaminate a significant number
of facilities around the country. We are continuing to work
with officials in the state of Florida in our Region 4 on
the AMI building down in Florida.
And interestingly enough as a side note to one of the compounds
that is being looked at for that decontamination, it not only
includes the compounds that have been used in and around up
here, like Chlorine Dioxide Gas, but Methyl Bromide as well,
which has brought in a whole different group of people from
our office to help look through that. Sort through those issues
as well. So we continue to -- even though you're not reading
as much about it in the newspapers as you were at our last
meeting, we're working with a number of federal and state
officials around the country on facilities that still remain
contaminated. In particular, the Brentwood facility here in
Washington, D.C. remains closed and has not yet been treated,
and that's taking a fair amount of our time and energy in
the Antimicrobials Division.
As it relates to registration issues, just to remind you of
what I'm referring to in terms of registration issues, a number
of companies have sought to register products for making a
claim that it controls anthrax, and that has raised a number
of very challenging issues with the appropriate microorganisms
task. The surrogate. Should you be using a surrogate or should
you actually be asking that anthrax be tested, two issues
that I refer to as sort of the scope of the registration.
If you've tested in a petri dish, is that enough to say that
it can be used to decontaminate a 300,000 square foot building
and everything in between. And we have been working with the
industry, and we're beginning to reach out to some experts
in the area of microbiology who are not necessarily in the
industry to try to get our arms around these issues, which
are -- they're quite complex. The surrogate issue, in particular,
we've made a fair amount of progress on. We've gotten a fair
amount of help from our other federal partners, in particular
the Department of Defense, who have, no big surprise, been
working with anthrax and potential surrogates for some time.
Unfortunately, as of right now I cannot report that we have
figured out or decided as an agency, or I think as a government,
what is the appropriate surrogate for anthrax, nor have we
completely sorted through the appropriate -- the issues I
referred to earlier as scope. What exactly do you need to
test to be able to have a claim of controlling anthrax on
a pesticide label.
So we will continue to work these issues. We've got an industry,
government -- sort of an industry and government. It's largely
a nonprofit group looking at these issues, both the surrogate
issue as well as the registration labeling issues, and we'll
continue to keep this committee posted as we sort through
these complicated issues. Thanks.
MS. MULKEY: Okay. And now Pete will update us
on the experimental use permit initiative that we also talked
about at our last meeting.
MR. CAULKINS: Thanks. At the last meeting,
I did propose -- I walked you through our proposal for expedited
EUPs. The process. We put it out for comment. The comment
period closed the end of March. I received nine comments:
four from industry, three from grower groups and two from
other stakeholders. I think to summarize the comments, the
majority of them expressed a concern that the criteria were
too restrictive. We will be reviewing the comments, deliberating,
making those modifications that we deem appropriate, seeking
out upper management's concurrence and going final hopefully
by the end of the summer. So that's the status of that.
MS. MULKEY: Hold on. I'm listening to -- I made
the mistake of listening to the whispering behind me. Don't
And now you will remember we had quite an extensive presentation
from NIH and some information from some other sources about
what's going on with public health pesticide research and
related matters. And so Arnold Layne is going to update us
on development on that topic.
MR. LAYNE: Thank you, Marcia. As Marcia indicated,
at the last PPDC meeting we shared with you some of the information
that we gained from a meeting that was held less than a year
ago with a number of governmental agencies -- Centers for
Disease Control, the National Institutes of Health, Department
of Defense and the USDA's IR-4 Program. Today I hope to briefly
update you on some of the activities that have happened since
Here at EPA we still stand ready to expedite any pesticidal
new chemistry or technology for use in vector management.
We have taken every opportunity to encourage industry and
others to pursue these new chemistries for vector management.
We have a number of new chemistries in house for our consideration.
I'm aware of at least two companies that are exploring the
use of these new chemistries for vector management, including
mosquito control. We recently issued a public health emergency
exemption under Section 18 of FIFRA to a couple of states,
which enables them to use a novel product to combat and control
ticks which may carry the causative agent of Lime disease.
Although this product contains a previously registered pesticidal
chemistry, it's the technology and the approach that they
use that was quite creative and quite different. And what's
nice about it is there is very little, if any, environmental
exposure to this chemistry. We granted that Section 18 in
less than two weeks after receipt. We also have a full Section
3 registration pending and we hope to have that registered
At the last PPDC meeting, Dr. Kate Autman from NIH briefed
you on a number of activities NIH was pursuing in the fields
of vector biology, resistance, pesticide development and orphan
pesticides. In December of last year, NIH published a request
for proposals seeking partnerships for the development of
novel vector control strategies and infectious diseases. That
was also linked to a number of proposals for -- a request
for proposals for bio-terrorism. Hopefully this did not get
muddled in the bio-terrorism proposal. It's my understanding
that there were two rounds for submittal of applications or
proposals. The first round closed March 20th. The second round
closes June 20th. During -- late this fiscal year NIH expects
to fund three to 10 of these projects totalling six million
dollars in the form of grant money. According to NIH, these
proposals sort of run the gamut. And unfortunately, NIH couldn't
provide me any specific information regarding the proposals.
I think it's illegal for them to do so. So I don't have any
specifics regarding what types of proposals they have received.
The Department of Defense has been primarily focused on developing
personal protection products and equipment for our troops.
DoD is currently developing a new insect repellant in collaboration
with USDA's ARS. EPA registered a camouflage paint -- face
paint -- repellant containing a pesticide which DoD is gearing
up to begin using. DoD has also created and formed a number
of development planning committees for repellents, for dengue
control and also for West Nile Virus. EPA participates on
those committees, and we also participate on their Armed Forces
Management Board. And lastly, you heard a little about our
activities with the World Health Organization by our own Keith
Chanon, who actually spent some time with the World Health
Organization. In about a few weeks, EPA and CDC and FDA will
begin working with the European Center for Environmental Health
of the World Health Organization's European Region on a project
in the field of urban pest management which encompasses many
public health pests of concern, including cockroaches, which
as you all may know, is one of the causative agents of asthma.
So that's what we've done. Thank you.
MS. MULKEY: All right. Now, we have an opportunity
for both questions on these topics and any feedback you might
offer about whether this kind of update and continuity from
our previous topics is along the lines that you have been
recommending in terms of having this committee's work feel
more meaningful and continued. Bob?
BOB: I just wanted to ask Pete. Did you mention a deadline
by which the EUP guidelines would be coming out? I'm sorry.
MR. CAULKINS: End of the summer.
BOB: End of the summer. Thank you.
MS. MULKEY: Pete, I take it if we were to receive
EUP applications now, we could -- I mean, it's not like we're
MR. CAULKINS: Right.
MS. MULKEY: So if things are in align with what
we proposed and there is an interest, we can go ahead and
MR. ELWORTH: I was going to ask Pete. You mean
that you would use the guidelines on applications that would
be received now or not? The guidelines that -- because this
isn't an FR notice thing necessarily. These are guidelines.
So you could use the proposed guidelines now on EUP applications
that come in like tomorrow? Is that what you're saying? Okay.
MR. CAULKINS: Correct.
MR. ELWORTH: Okay. Okay. The other question
I had was for Anne on the risk assessment methodology. I was
interested in the presentation at the last PPDC meeting. What
I wonder is whether the agency is planning to look back at
the impacts in terms of registration, either for biopesticides,
reduced risk pesticides or all the other registrations, and
look at what impacts the inert risk assessment is having on
registration, either the speed at which registrations are
coming out or any difficulties you have in getting registrations
out the door. For new registrations, I would actually be interested
in where the industry is on that as well. Are you all going
to look at that at some point?
MS. LINDSAY: I'm actually going to let Pete
MR. ELWORTH: Okay.
MS. LINDSAY: I'm the deliverer of the status,
but Pete is the --
MR. ELWORTH: Okay.
MR. CAULKINS: At this time -- your question
is whether we're going to look back at --
MR. ELWORTH: Well, I'm interested in the --
it's interesting enough to look at the risk assessment methodology
and everything. I'm interested in what effects it is having
in terms of registrations.
MS. MULKEY: Resource diversion, right?
MR. ELWORTH: Not -- no. Not just resource diversion.
Whether in fact inert concerns are holding up registrations
in some cases and the speed at which things are coming out
in terms of the output from RD and BPPD.
MR. CAULKINS: Right. I think right now we have
a very substantial backlog.
MR. ELWORTH: Okay.
MR. CAULKINS: I would say it's a three to five
year backlog, so obviously we're having an impact, I believe.
So that's why we've been piloting this methodology. We'll
be taking comment and we'll be revising as we go. But, yeah,
we need to address that backlog.
MR. ELWORTH: Yeah. That's the issue I wanted to raise,
if that in fact is an issue and whether, you know, you all
can report back to us on kind of how things are going and
so forth as part of this update.
MS. MULKEY: Okay. Dan?
MR. BOTTS: I apologize if I missed this in the introduction
to this methodology issue. But is this -- can we interpret
this as being part of the noncontributors discussion that
we had on the other stuff? This is not modeled or not -- a
totally different program process? I'll save my follow up
question for later, then.
MS. MULKEY: Al?
MR. JENKINS: Arnold, I wanted to follow your comment
about the work on cockroaches with the European Group. Could
you repeat that just briefly for me?
MR. CAULKINS: I'm sorry?
MR. JENKINS: Your comment about working with the European
MR. CAULKINS: Huh-huh.
MR. JENKINS: -- on cockroach control. Could you repeat
MR. CAULKINS: It's actually a great number of
urban pests included: rats, roaches, mice. WHO approached
us early last year about us engaging with them and some other
governmental entities on a pest management -- urban pest management
project that they're hoping to begin early this year. And
the objective of this project is to sort of look at pest management
control mechanisms with respect to controlling these public
health pests, and hopefully come out of there with some measures
that governments or industry or the pest control technology
industry can use when combatting these pests that are in urban
MR. JENKINS: Who is involved in that? Is --
MR. CAULKINS: The Centers for Disease Control.
MR. JENKINS: Is it just governmental agencies?
MR. CAULKINS: The Centers for Disease Control,
the Food and Drug Administration, EPA. There is the Center
for Environmental Health that I think WHO works with quite
regularly, and they're involved as well. I think possibly
the Brits are working as well on this project, and I think
they have pursued some other countries as well.
MS. MULKEY: Okay. Warren?
MR. STICKLE: First of all, I want to thank the agency
for moving the methodology for risk assessment for inerts
through the process. It has taken, I realize, a great deal
of work to get that done, and a long time ago you set a goal
of trying to have that done by the PPDC meeting today. So
thank you very much for doing that and getting that done.
Is this paper available on your web site at this point in
MS. LINDSAY: Warren, I don't think it's on the web
site yet. It will be very shortly.
MR. STICKLE: It will be. Will there be a 90 day comment
period for anyone who wants to comment on it?
MR. CAULKINS: Yes.
MR. STICKLE: Are you going to put in a Federal Register
MS. LINDSAY: Yes. There will be a notice available
MR. STICKLE: Okay. And then a 90 day comment period?
MS. MULKEY: You're actually getting an early copy.
MR. STICKLE: I see. Okay.
MS. MULKEY: And it's conceivable -- I don't think it's
likely -- that the actual draft that is put out for comment
will have a little additional editorial work on it.
MR. STICKLE: Okay.
MS. MULKEY: So this is basically because you're the
committee that you're getting this copy. But we're ready.
I mean, we're days away.
MR. STICKLE: That's very good. With that in mind, I
wanted to just take a moment to make an announcement that
Crop Life America and the Chemical Producers and Distributors
Association are going to be putting together a joint workshop
on this issue on June 12th and June 13th. And we would really
appreciate the support in working with EPA on this project.
Thank you very much.
MS. MULKEY: Thank you. All right. Do we have any more
questions or feedback about this? I'm assuming that in the
absence of griping that you are finding this level of continuity
about previous topics useful, and we will commit to continuing
so that once you have invested in a topic, that you have a
sense of some continued engagement with us on it.
We now go to a set of what we are calling Updates in a Minute.
They're not literally 60 seconds, but we are -- our aim is
to keep them pretty close to that. In some cases, these are
topics where some of you wanted a much more substantial involvement
in the topic, and for a variety of reasons that didn't seem
to us to be appropriate at this point in time. Nevertheless,
we wanted to meet the need -- at least the basic informational
need that you may have had regarding these topics. In addition,
we are mindful that this is a wonderful opportunity for us
to clarify the status of matters, and we have picked some
topics where we wanted to take this opportunity to be sure
that everything was understood. Is Randy here and ready? Okay.
The first topic, the OP revised cumulative risk assessment,
of course is one in which there is extremely keen interest.
There is, as you know, another advisory committee co-chaired
by the Deputy Secretary of Agriculture and the Deputy Administrator
of EPA related to tolerance reassessment and transition, and
this subject has been very actively worked with stakeholders
in that forum and will continue to be. So the reason for raising
it here is solely because we didn't think we could get away
without giving an update on a topic of that interest. But
it's not to bring that topic into this forum, although actually
we do anticipate that a work group of that committee will
be meeting around issues related to this topic in June. So
we're not far away from an actual active committee related
meeting on this topic. But Randy is going to give us a status
update for this group.
MR. PERFETTI: Thank you, Marcia. Good morning, everyone.
As you all know, the OP cumulative risk assessment public
comment period closed in March. Since that time and even as
we speak, we're looking at the public comments and the SAP
comments and revising the assessment. In June we plan to issue
a revised assessment and put it out for public comment and
yet another SAP review.
Also in June, there will be a technical briefing for anybody
who is interested on this revised OP CRA. Also in June --
June is going to be a busy month for us -- there will be another
SAP review. Sometime in July, the public comment period will
end for this, and we plan to take those comments, as well
as, again, the SAP comments, and incorporate them into the
revised assessment and issue it in August. That was much less
than a minute, I think, Marcia.
MS. MULKEY: Very impressive. And then the agency's
determination regarding the Triazine class of pesticides and
how and whether they operate by a common mechanism has also
happened since we last met. And so Randy is going to give
us a little information about that.
MR. PERFETTI: Yeah. The Triazines actually had sort
of been linked to a common mechanism a long time ago, but
we have relooked at the whole thing. Based very much on the
industry information received -- but also I have to put a
plug in here for ORD. They have done a tremendous job in helping
us understand the mechanism by which the Triazines work.
The preliminary document was released for public comment April
2nd, and that comment period closes June 2nd. The document
concludes that Atrazine, Simozine and Promazine and several
of the metabolites share a common mechanism of toxicity based
on a hormonal mode of action. And that's about where we stand.
I certainly hope everybody read it and comments on it.
MS. MULKEY: Okay. Thank you. I'm going to -- we're
going to work through the remainder of these, and I think
if we keep them at or near a minute, we'll have some opportunity
at the end of this session for anything of interest. The human
studies topic here is, of course, focused on actually quite
a narrow set of studies that some companies have conducted
on some compounds and submitted to the agency involving the
use of human volunteers in experimental tests to evaluate
the toxic endpoints or the toxicity of pesticidal compounds.
None of EPA's data requirements require that particular kind
of studies in human test subjects. There have been for some
years now some extensive and controversial issues relating
to both the science and the ethics of this particular type
of experimental study. And the most recent development in
that regard occurred in December when the agency announced
that it will seek the advice of the National Academy of Sciences.
And not only the advice of the National Academy, but ask the
National Academy to engage in an open public and participatory
process in the development of its advice about the appropriate
use of these studies. Now, this is sort of an arcane area,
and one has to speak with a lot of precision. There are studies
conducted in human volunteers under funding by or directly
by the federal government for certain purposes. Those studies
are covered by what is called the common rule, which is a
federal government regulation governing the ethical elements
of the conduct of these studies. The third party studies submitted
to EPA, whether on pesticides or on other substances of this
type, are not by law governed by the common rule.
And so the set of questions we have asked has been narrowed
to the subset of studies which are third party studies submitted
to EPA and sort of by definition not governed by the common
rule. In addition, we've tried to make it clear that it is
this group of human studies that involve experimental direct
dosing for the purposes of establishing toxicity. There are
a number of studies that are conducted in human test subjects
that we have long and quite routinely considered, and some
of them are even contemplated by our guidelines. Things relating
to such things as the efficacy of insect repellents, relating
to pharmacokinetics analyses and so forth. All of those, because
they involve human test subjects, can raise ethical issues.
And in fact, FIFRA has an express provision that no pesticide
may be tested on any human subject for any purpose in the
United States unless there is full informed consent. I don't
have the exact words in front of me. But there are some specific
statutory requirements with regards to pesticides. We continue
to work with those studies, and we continue to evaluate those
studies. And should we obtain any information that raises
questions about the ethical conduct of those studies, we will
of course pursue it.
But with respect to this subset of studies where the ethical
evaluation issues, as well as some key science issues, remain
so unresolved, we have also stated that we will not be actively
considering them in connection with our regulatory work unless
they give rise to some information that would require us to
take steps to be protective of the public health. Now, this
is now the subject of litigation. There was litigation brought
by Crop Life America and two of their member companies alleging
that the announcement relating to the agency's approach to
this and referral to the National Academy of Sciences represented
an action -- a rule-like action -- subject to review. And
one of the things that happens when you have a lawsuit, is
you can go read the briefs and see what people think in that
context. So you're welcome to -- there's been one round of
briefs as to whether the matter warranted expedited consideration.
And so you get to see the kind of things that the industry
was saying about it. You also get to see the kind of things
that EPA was saying about it in that context. In fact, the
court ruled and determined that the matter did not merit expedited
But that matter will continue in the NAS forum, which is supposed
to be open in public. It will continue in the courts. And
the third forum that there is some interest is a federal government
advisory committee on human test subjects, which has held
one recent public meeting in which there was some discussion
of this issue as well.
So that's the human studies issue. Atrazine is just -- happens
to be one of many pesticides in which there is a broad interest.
It is very widely used, and so that is certainly one of the
reasons why there is a lot of interest in Atrazine. Atrazine
has been going through our six step process. It's in reregistration.
It's in tolerance reassessment. We have just published the
revised risk assessment, so it is pretty advanced in its consideration
in that context. And I just wanted to call your attention
to the fact that it is in that posture. In other words, we're
sort of pretty much to the end of the open public dialogue
about risk assessment, and we are beginning to move into the
dialogue and the agency deliberations about risk management.
So it's in that posture.
We are mindful, as I'm sure some of you are, about recent
public indications of study and information that we had some
knowledge of and continue to work with relating to some testing
of the substance in amphibians. And actually, Atrazine is
an extremely frequently tested substance, both by the company
and by our own Office of Research and Development and by other
researchers. And we are, of course, as we always do, paying
attention to all available, reliable information on that compound.
The next topic is what we have listed as the false and misleading
names PR notice. For some time, EPA had regulations that define
what constitutes false and misleading claims. And in addition,
we have always paid a lot of attention and have regulations
relating to certain particular kind of claims that we're concerned
about, like public health claims for pesticides where there
has not been the necessary documentation of public health
effects and so forth. It has become clear to us over the years
that there is some moderate but meaningful expansiveness of
the use of either company names or product names to convey
messages very much like claims or in some cases actually containing
And this PR notice is designed to address the issue of those
problematic claims, or claims not permitted under the regulations,
or claims that are not committed under the FIFRA prohibition
on false and misleading claims, that may be contained in company
names on products. Obviously if the company name is not on
a product and not associated with the product, it doesn't
raise issues about claims. But company names and product names.
And that is out for public comment, and we've just extended
the public comment period, if you're interested. And my final
piece of this is Metolachlor and S-Metolachlor. This is also
the subject of litigation, so I will say relatively little
about this topic. But for those of you who have not been following
it -- and I know some have been following it very closely
-- for a number of years there was a product marketed -- Metolachlor.
It's a herbicide.
And at some point, the company, which is Syngenta, developed
a way of refining the molecule so that it lost one of its
arms in extremely simplistic forms, and that what remained
was a molecule which retained all of -- or virtually all of
-- the herbicidal activity of the fuller molecule. But because
it was a smaller molecule -- and I'm probably mixing up the
science a little bit here. But essentially was capable of
serving its herbicidal purpose in lower absolute volumes of
the material. And they brought that to the agency seeking
registration of this refined molecule as a new active ingredient,
and indeed as a reduced risk ingredient, arguing that it was
reduced risk because it involved less volume. But also stating
that all of the data on the toxicity -- environmental FATE
-- and other properties of the original molecule were relevant
and appropriate to support the registration of this new ingredient.
EPA essentially agreed with some subtle involvement involving
analyses as to whether that was correct and also engaged with
the company in discussions about the phase out and eventual
voluntary cancellation of the original product.
During the ensuing period, and after the company had asked
for voluntary cancellation but before it had been effectuated,
the agency received me two applications on the original molecule.
The agency considered those for some considerable period,
and earlier this calendar year granted me two registrations
to now I think it's three different entities for the original
-- based on the original -- the registration of the original
And all of that actually has been the subject of litigation.
It was the subject of litigation last summer and there is
now additional litigation. And again, one can read the briefs
and learn all you might ever want to know about what the company
and EPA thinks about the legal proprietary and also some of
the technical, and increasingly, I think, more of the technical
and policy considerations. But I don't plan to talk about
them freely today, primarily because they are in litigation.
And that leaves us with three updates in a minute, Anne. All
MS. LINDSAY: In one minute?
MS. MULKEY: No, each, and actually a little more.
MS. LINDSAY: The first one is spray drift. Most of
you probably know we actually put out a draft PR notice on
improving labeling of products with regard to spray drift
and spray drift mitigation last August. The comment period
closed at the end of March this year, so you can see we had
quite an extensive comment period. And we got quite an extensive
set of comments, actually 5,249. We've counted them all. I
would say a vast majority of them, about 3,500, are standard
comments, but there are still about 1,700 individual comments,
principally from growers and ag retailers. And in general,
I would say growers and ag retailers had a very unfavorable
response to the proposal. But we also got what I thought was
a significant number from private citizens, mostly because
in my experience ordinary people don't usually comment on
agency documents. They're not deeply engaged in the process.
So about 6 percent of the comments that came in actually were
from private citizens and most if not all of those were actually
in favor of changes that would actually mitigate risk. And
I think this is because many of them were involved at some
point in their life in drift issues, and so it was an issue
that resonated with them.
In terms of the types of issues that the commenters are raising:
concern about the wind speed recommendation being unrealistic,
height of application, some issues around orchard application
methodology -- don't ask me questions about that, because
I'm not an expert on that -- and economic hardship concerns
that farmers and growers would need to get new equipment to
comply. And then finally, I think primarily from AAPCO and
individual states concerns about whether the new proposed
language was really going to improve enforcement where it
was necessary to actually take enforcement action. So what
we're doing currently is analyzing what we got in a little
bit more detail. And although we got a lot of, like I said,
standard comments, there were about 50 submissions that really
had additional data, real information or analysis of their
own that require us to really go through and see what is there.
So there is a substantial amount of just internal work to
deal with those 50 submissions that have got lots of meat
So we're going through a period of analysis this summer and
fall. We're also going to be looking at what I would call
other opportunities to dialogue around the issues that the
draft PR notice raised. And we may be doing some workshops
in different parts of the country. We're already trying to
take advantage of as many just existing meetings and opportunities
to talk with people. So that's my update on spray drift.
MS. MULKEY: We've committed to repropose?
MS. LINDSAY: Yeah, sorry. We committed to repropose.
My second topic is on worker risk and in particular a worker
risk seminar. At the most recent CARAT meeting -- actually
at the end of the CARAT meeting, the agency made a commitment
to find some mechanism or venue way of coming back to worker
risk issues. And we've done some what I would call just very
early preliminary thinking about how we might start that process,
and that's what I would like to share with you right now.
First of all, in our minds you'll see we're calling this at
this point a seminar, and that's because we think the place
to start is with education. We have identified what we think
are four what I'll call principal topics around which a seminar
might be organized, the first of which would simply be how
does EPA currently do worker risk assessment. I think some
(End of Tape 1, Side A.)
MS. LINDSAY: -- worker protection standard. The different
ways in which we're trying to upgrade the field programs.
Hazard communication issues, for instance. The third part
would be -- I don't have as good a title for it. But it's
kind of what I would call broader science developments. There
will actually be an international meeting this summer in July,
the Society for Occupational and Environmental Health. It's
a very scientific meeting. There will be lots of people presenting
different scientific papers on bio-monitoring, epidemiological
work and that kind of issue. So this third part of our seminar,
I'm currently envisioning as perhaps being the highlights
of the type of work that will be presented far more extensively
at the July -- we call it SOEH. That's how you pronounce the
acronym. The Society of Occupational and Environmental Health,
And then the final part for the worker risk seminar would
deal with application technology. What's there? How extensively
is it really being employed? What does the future show in
this area? So those would be the four broad pieces. Obviously,
EPA would have a large role in being presenter in various
of these sessions. But we're also going to be looking for
outside presenters, because we know that we don't contain
all of the expertise within ourselves. And we're envisioning
that this would be set up in such a way that there is both
ample time for the presentation education part, but also ample
time for questions, discussion and dialogue. And so the end
result, if this plays out well, is I think everyone who has
a concern and a stake in worker risk issues would leave the
seminar with kind of a common base understanding of principal
areas that relate to worker risk and worker risk mitigation.
We had originally thought we even had found a time for the
seminar, which would have been in mid-July following the SOEH
conference, but that proves not to be such a good time. There
are a number of different stakeholders who we really want
to have attend the seminar who had prior commitments that
can't be rearranged at all. So we're now in search of a different
date, and I don't know that Margie has yet found a suitable
date. No, she hasn't. So we will be getting back with more
specifics about time frames. But in putting the actual --
in moving from these sort of broad concepts that we've got
right now, we'll be working with USDA, and I think actually
with a lot of others of you around the table and outside this
meeting, to actually put the details of the seminar together
in terms of individual topics within the sessions and who
might actually be good presenters for different perspectives
on the topics. And, of course, if you think there is a major
area that doesn't fit neatly into these four parts that we've
identified for ourselves, we need to know that. Because I
think we're at the place where we have quite a bit of flexibility
as to what the seminar would be like.
And then finally, NAFTA. A little bit on NAFTA. You probably
-- or most of you know that we do have what's called the NAFTA
Technical Working Group on Pesticides. This is a government
group that was established shortly after the NAFTA treaty
itself went into effect, and it was to look broadly at issues
affecting pesticides in the three countries -- Mexico, U.S.
and Canada -- that may inhibit trade, but also at the same
time to look at how do we actually maintain or even improve
the levels of human health and environmental protection in
the three countries. So it had the sort of balance of trade,
but also public health protection. To start the work of the
NAFTA Technical Working Group, the group actually developed
a five year plan. You don't have it in your packet, but out
on the table there is a milestone report from the NAFTA Technical
Working Group that describes the original five year plan.
We're coming to the close at the end of this fiscal -- or
calendar year, rather, of the first five years.
And so the NAFTA Technical Working Group is in process right
now of developing a second five year vision for itself, and
I would expect sometime this summer there will actually be
an opportunity to have some kind of consultative process around
that second five year proposal. It will be built first and
foremost on the first five years worth of experience, and
so a lot of what you would actually see in the milestone report
will be a basis for the second five year plan. But we also
had a meeting in Mexico City last November in which we had
extensive stakeholder involvement. It was actually done in
kind of a work group style, so there were breakout sessions.
Some of you were actually there and contributed to that. So
we'll be taking input from that meeting in Mexico to build
the next five year plan. And then most recently, we have gotten
submissions from two industry groups. The official NAFTA Industry
Working Group, which represents largely agricultural chemicals
and uses, and the newer nonagricultural working group, that
represents nonagricultural issues from an industry perspective.
So we've got two very, very meaty submissions from those industry
groups that we'll be using to develop our next five year plan.
And we're open to other input. So if others of you who have
not had a chance to think about this and feel that you have
something that you want us to consider, there is very much
an opportunity to do that. And then the draft will be available
sometime this summer. All three countries will take comment
on it, and we would hope to have it finalized by the next
full meeting of the NAFTA Technical Working Group, which will
be in December in New Orleans. So that's it.
MS. MULKEY: And I should wrap up this segment by saying
that on these topics, I think on virtually all of them, we
are involved in working with USDA to some extent and where
appropriate. But two of them, the one on the cumulative risk
assessment -- at least the part of it that has to do with
engagement in the stakeholder process and related matters
-- and the worker risk seminar, both are under the rubric
of the CARAT, and therefore there will be a particular effort
to plan our stakeholder involvement jointly with USDA on those
All right. Well, we can take a few questions and still stay
on time, and if there is a lot of interest in a dialogue,
we'll accommodate that. Let's start over here. It works, especially
since the first card is over here. Jay?
MR. VROOM: Oh, thanks. One question about one of the
one minute updates that I wasn't clear on from Randy. When
is it that CARAT or the CARAT subgroup will meet following
the cumulative technical briefing? Do you have those dates
MR. PERFETTI: Normally it's the day after. I'm sure
it will be the day after.
MS. LINDSAY: It's July 19th.
MS. MULKEY: No, no. It's not July 19th.
MR. VROOM: June 19th.
MS. LINDSAY: The day after.
MR. VROOM: Okay.
MS. LINDSAY: And it will be at EPA's offices in the
Fishbowl. It'll be in the Fishbowl at our offices in Crystal
MR. VROOM: Okay.
MS. LINDSAY: And the technical briefing is at the Holiday
Inn in Old Towne. Oh, I'll send that out to you all.
MR. VROOM: Great. Two things that I think have emerged
since we dialogued and provided input on the agenda for this
meeting that I would hope that we might find some time to
address in this forum briefly. One is resources for the Office
of Pesticide Programs, given the failure of a fairly comprehensive
group of stakeholders who tried to convince the Congress to
include something with regard to that in the farm bill. I
think that's important and timely for us to find some time
to add to the dialogue here if we can squeeze it in. he second
is a trend that we have noticed emerging with regard to public
objections. And all the ones that we're familiar with have
come from NRDC with regard to new tolerance approvals on new
chemicals. It seems to be a significant trend, given the volume
of those objections that have surfaced. And I'm not sure where
that topic could be added to or incorporated into the existing
topics that are on the agenda for today and tomorrow.
But I'm curious to get some idea from the agency as to what
sort of transparency and due process steps may be added or
provided to allow for other participation in that -- in the
follow through on those comments and objections.
MS. MULKEY: And maybe I can answer at least a little
piece of that. I don't know that we've yet done it. But we
are preparing to publish the objections that were filed at
least with respect to -- and what I'm a little unclear about
is whether it's every tolerance or whether it's like the first
one. But we're mindful that this issue, like all others, needs
openness, transparency and process, and we are publishing
those objections. And I don't know if there is anybody here
who can be more specific than I've just been about that publication
of those objections?
MS. LINDSAY: I think the answer is no.
MS. MULKEY: Okay.
MS. LINDSAY: Our state of knowledge is about yours.
I know that the actual publication has been drafted, so I
would expect it to occur shortly.
MS. MULKEY: Okay. Gary, since we're over here.
MR. LIBMAN: Do you have resources, do you think?
MS. MULKEY: Well, I'm going to think about that. We
have, at your request, a discussion of the sort of sub-issue
of our current operating plan as it relates to registration
resources. And Joe Merenda is going to be here, and he sort
of works budget issues for us. So that may be an opportunity.
I want to think about that, if I may.
MR. LIBMAN: Just a real fast one on the math, then,
from your perspective. As a stakeholder, I can say that there
has been some substantial progress in the last five years.
When is the next meeting?
MS. LINDSAY: The next meeting will be the first week
in December in New Orleans. And I can't actually now remember
the specific dates of the first full week in December. Warren,
you may actually.
MR. STICKLE: It's the 2nd, 3rd and 4th, in the middle
of the week, Tuesday, Wednesday and Thursday.
MS. LINDSAY: Yeah.
MR. LIBMAN: And that will include stakeholders as well?
MS. LINDSAY: Yeah. Yeah. It's a public meeting. It's
a public meeting.
MR. LIBMAN: Okay. Do you find that in the past Mexico
had kind of lagged a little behind Canada and the U.S., certainly?
Is that changing a little bit?
MS. LINDSAY: I think we're seeing actually very active
and significant participation and real leadership from Mexico.
They're actually, I think, very straightforward that they
do not have the kind of capacity that the U.S. does, for instance.
But frankly, I don't know another country that has the sort
of capacity that we do.
But they are very bright. They are very sharp. They're very
committed and dedicated, and I'm real pleased with the sort
of participation and leadership that we're experiencing.
MS. MULKEY: All right. Well, there are several cards
up. That's good. We're past time for the break. So I suggest
we work through a couple and that we regroup at that. So,
MR. BOTTS: Thank you. Mine deals with topic number
eight on the worker risk seminar. Having been engaged on this
issue, specifically on trying to figure out how the worker
risk assessments are done in that process, the original discussion
that we had with the agency about the need for this was to
develop an understanding across all stakeholders exactly how
the process works. I applaud the additional issue items there.
But having attempted to dig through this to really get to
the bottom of it at the detail that we need to on exactly
how those risks are done, I think this agenda is way too big
to do what I think we were asking for in the original discussions
that we had. I still think we need to get that base understanding
of how the worker risk assessment process works. What the
inputs are. How they're utilized by the agency. How that discussion
takes place. And that's a full two day meeting to get through
those kind of details if we want to open it up to the level
of transparency that we need to get to to be able to effectively
deal with the worker risk mitigation issues at the end of
the day as the IREDs and the cumulative exposure assessments
and everything are coming to the end.
MS. MULKEY: Well, why don't we look into it.
MR. BOTTS: And I would be happy to serve on the steering
committee, just because I thought that there had been a steering
committee put together at one time to work on developing the
agenda for this meeting.
MS. MULKEY: I think we have time to work through that
issue. I think our goal is to try to be sure that we do have
something that gets to the level that it meets people's needs.
So I think we're very open to working through that issue.
MS. SPAGNOLI: A couple of questions regarding the spray
drift and the PR notice. Are there plans to issue a draft
-- a new draft or a revised draft for comment, or is the plan
to try to go to a final PR notice?
MS. LINDSAY: No, no. I think I said that too quickly
at the end. We are going to actually put out a reproposal
at some point.
MS. SPAGNOLI: Okay. So it will --
MS. LINDSAY: After we slough our way through the analysis
and other dialogue.
MS. SPAGNOLI: So there will be an additional comment
MS. LINDSAY: Yeah.
MS. SPAGNOLI: And then my second question with regard
to the spray drift, I think in some cases that there has been
requirements for label language on products based on that
draft. Are they going to kind of, I guess -- do registrants
who maybe have been asked to put label language on, do they
have some recourse at this point, knowing that it's going
to be reproposed or revised?
MS. LINDSAY: Well, I actually believe that what we've
tried to say is that we're not requiring anybody -- we had
not required, and we currently are not requiring anybody to
actually take the label statements in the draft PR notice
and put it on their label. We were, I think at least early
on, approached by some registrants who had an interest in
using some of those label statements, and in those cases we
thought it was appropriate to basically give the flexibility
to do that.
I would assume, since this seems -- I think it's always our
posture that if there is a registrant who has some current
statements on there that you would like to reconsider, the
Registration Division is always open to that.
MS. LINDSAY: I don't know. Pete is not looking open.
I was expecting an open look on his face. Now he's looking
MS. MULKEY: Larry?
MR. ELWORTH: I just want to reinforce what Dan said.
I think it's a good idea to have a seminar. I think it really
is two days on risk assessment at least. And I think it's
good to engage a lot of people in working on the agenda. I
would recommend that given the intensity of interest on this
issue that it might be useful to pull together a set of people
who actually work rather intensively with you on the agenda,
especially since I think you're going to be looking for a
lot of interaction and a lot of opportunity for people to
ask maybe some fairly detailed questions. So getting at least
some either formal or work group to work on that would be
MS. MULKEY: Shelly?
MS. DAVIS: Well, I first want to talk about that, too.
In our view, the issues of risk assessment and risk mitigation
are intimately entwined and really cannot be separated. And
so I would really like at least those two pieces of this puzzle
to be put together. I also think that there has been a lot
of interesting studies in recent years in the area of epidemiology.
There has been a recent cancer study and exposure, and I know
there is more data in terms of sensor data. So we really should
have the best picture we can of what we know about what is
actually happening, as well as the theory of how you figure
out risk assessment, so we some sense of, you know, the validity
of these risk assessments. I would actually agree with Dan
and Larry on the idea of the validity of a steering committee.
Because since this is supposed to meet the needs of the CARAT,
it would probably be helpful to have some of the CARAT members
be part of the folks putting it together, so that our questions
really get answered.
MS. MULKEY: Okay, thanks. Thanks to all of you. And
it really is helpful. That's why we raise these issues in
this forum.Well, we did, I think, pretty well about getting
this many updates in very few minutes. But we have lost 10
minutes, and we don't really want to limit the full comprehensive
discussions that we plan. So the answer to that is for all
of us to be back in our seats and back in business in exactly
15 minutes. (Whereupon, a brief recess was taken.)
MS. KNOX: We'll use the usual process. Put your name
tag up and we'll go around the room to try and record additional
barrier constraints or issues. After the lunch break, we'll
come back and have an hour, during which time we really want
to do a brainstorming on possible solutions to the issues
to the problems. Are there ways we can overcome some of these
For just an hour. It will be pretty much only a brainstorming
session, and then Janet and I will take back the results from
this and basically go through not only the barriers, but the
possible solutions, and put together a report that we will
send back out to the committee. We may use the on-line chat
room to publish it and to get comments back and forth, and
hopefully in the near future use those results to come up
with some kind of an action plan that we can bring back and
present to the PPDC. That's the format. The panel is Janet
Andersen, who is the Director of the Biopesticides & Pollution
Prevention Division, Bob Holm, IR-4, to talk about their biopesticide
program, Gary Libman, who represents the biopesticides industry,
Al Jennings from USDA, Win Hock, who will represent the land
grant university perspective, Lori Berger to represent grower
groups -- grower agricultural user groups -- Steve Balling,
who will represent food processors, and Carolyn Brickey, who
represents the environmental and public interest groups. So
Janet will start. I think overheads will be projected in both
MS. ANDERSEN: And this microphone -- okay, it's working.
Overcoming barriers of not having (inaudible), we brought
our backup slides. I want to thank everybody at PPDC who has
been so interested in this topic, and especially the panel
members who are making presentations today.
Pineapple, the first one. We're going to start off and look
at what are biopesticides. To us they are microorganisms,
both the naturally occurring and the genetically engineered
one. They are biochemicals, which are natural compounds, or
they are synthetic directives of that same compound which
have a nontoxic mode of action to the target pest. They are
biochemical like. That means that they are natural substances
or something like that, where we know already a lot about
it and we ask for a reduced data set. We bring those into
BPPD on a case by case basis. And they are the planned and
incorporated protectants, or those compounds produced by plants
that are pesticidal. And we aren't going to be covering those
today, as Marcia said. The history about pesticides, and probably
lots of people don't realize, but their registrations go back
clear to the '40's. There were both biochemicals and microorganisms
registered as pesticides in the '40's. That's biopesticides
that were in the '40's. But BPPD, a division just to look
at biopesticides, was not established until 1994 as a pilot,
and it had the mission to expedite the registration and reregistration
of biopesticides and to encourage the adoption of safer pest
management practices, including the use of biopesticides.
Next. But today the biopesticide active ingredients -- as
we started out, we had about 125 active ingredients that we
classified as biopesticides in 1994. We have registered 90
new active ingredients to date. So the idea of expediting
the registration, in seven and a half years we've done 90
compared to many other first years of 125. We have expedited
the process. Currently there is 197. You can quickly do the
math and realize that we've lost some of those biopesticides
over the last few years, unfortunately. I'm going to cover
several examples of what our biopesticides are. I thought
I would start out by saying that -- I often say we do everything
from baking soda and vinegar as biopesticides all the way
to cutting edge biotechnology products in a small division.
We're the smallest division in OPP.
So reduced data set products like vinegar and baking soda,
we know an awful lot about these compounds already. We don't
need the full data set that you do for conventional and synthetic
chemical pesticides. But baking soda works by changing the
PH on the leaf surface. And fungi like acidic and this makes
it very basic and the fungi don't grow. And vinegar, it doesn't
take much to imagine that it can work as an over side, and
it does and is registered for that use. It obviously won't
replace Atrazine, but it has its uses. Carbon proteins are
a genetically engineered product. This is a case where a genetically
engineered bacterium produces a natural plant protein that
is grown in a fermentation system. The bacteria is killed.
They harvest the protein and they use it on the plants as
a fungicide. It's a very interesting new system where it is
stimulating the plant's own immune system in order to work
as a fungicide. And compared to a B2 carcinogen, we're pretty
excited about this kind of technology.
Probably the classic biopesticides are the pheromones, which
are nontoxic and used at very low application rates, and many
of them are long chain fatty acids which we have very little
risk concern. They work often by mating disruption or as an
attractive, and many of these products are actually used in
combination. In your packet, you have a list of all the active
ingredients that are biopesticides. Lots of long names. When
you put those in combination and you do one at a 20/80 combination
and another at a 40/60, you will affect a different insect.
So it's quite a specific and interesting technology in chemistry.
We have gone through a process of pesticides to really streamline
the registration process, especially for these long chain
fatty acid pheromones. And this process we have worked through
Canada, and now we have worked through OECD. And for OECD
countries, our approach to how we regulate these products
is what they're all using. Next one. For microorganisms the
oldest one we have registered was Bacillus Papillae back in
the '40's. It is for milky spore disease and controls Japanese
beetles. The most common one people know about is Bt. It's
probably the most commonly used biopesticide. But there are
lots of other ones that are very interesting and quite widely
used. The Forest Service especially uses Jibcheck, which is
an insect virus, a Bacilli virus, as they're called.
We recently just registered a new Bacilli virus, Indian Meal
Moth virus. Have you ever seen those little moths flying around
in storage product food sets? That's Indian Meal Moth, probably,
and it is a Methyl Bromide alternative where they are using
it for stored fruits and nuts. But those microorganisms actually
that we use are also competitors of other organisms out there
-- other pests -- whether they be fungi bacteria or insects.
But we don't do just agricultural ones, and we thought we
would highlight a bit of it. For mosquito control, we have
a Bt version called Israeliansus that controls insect black
flies and mosquitos. We have Methaprem. We have a fungus called
Lagenidium Giganteum. We have another bacterium called Bacillus
Thuringiensis, and then Optinal, which is actually an attractant.
It brings in the insect and they have some mechanism to kill
it, whether they're using a toxic mechanism or another one.
But there is quite a bit in that area, and there comes to
be even more on the area of repellents. I've started off my
list with the classic Citronella as an insect repellant. But
we've also recently registered both Diallyl and IR35-35, which
are insect repellents -- very effective -- and they are based
out of Eucalyptus products.
The next one I have on the list is Methyl Salicylate, a very
interesting insect repellant, but it's also been long registered
as a repellant for dogs and cats. But Methyl Salicylate at
very low doses in packaging can repel storage product insects
and certainly beats -- to be, beats the idea of using DDDT.
Methyl Anthranilate is a bird repellant. So just to show you
we go all cans of ways, we also have several repellents for
mammals, too, like Blood Meal and other kinds of things. I
just want to end up by telling you that we in BPPD are very
interested in ways we can encourage the adoption of biopesticides
and some things we are actually doing. We are doing a number
of things to improve our processes. Little small improvements
always make up for having not -- at least it overall makes
up for a bigger chunk of seeing results in improving your
We want to have a program where we assist registrants. We
do a lot of work this way. But we had a workshop last fall,
and we'll be putting out proceedings and going to a real workbook
for biopesticide registrants. We have lots of material on
our web site, and we're often praised for the web site and
the material we have on there.
We do joint reviews not only with Canada, but also we're working
on one right now with California and hope to do more. They're
recognizing how important California is to the biopesticide
industry. Our PESP activities are often aimed at having grower
groups learn how to use biopesticides or other safer pest
technologies and really having growers encouraged to use those
products in the future. And not to steal what Carolyn may
be talking about, but just to say that we have a program where
we're looking at the national organic standards program, so
that we can have a designation on those pesticides that actually
meet the requirements for the national organic standards to
have a designation for use in certified organic production.
And with that, I'm going to turn it over to Bob Holm. And
he wanted a stand, I think.
MR. HOLM: Thank you, Janet. That was an excellent introduction,
and I think Pineapple's got my slides. So to start out, I
thought I would give you a little background about the industry,
because a lot of people aren't really familiar with the industry
and what's going on. As Janet mentioned, the products have
been around since the '30's and registered by the EPA in the
'40's. You've got to look at the global market for biopesticides.
It's about 300 million dollars. Microbials is a little over
half of that. Pheromones and biochemicals. I guess for a strict
purest, the insects or the predators wouldn't be classified
as part of this in the U.S., but they are globally classified
in this market. But strictly for the biopesticides, it would
be about a 260 million dollar market. And put that in context
with the global crop protection market, you have about 28
billion dollars, which is down about 10 percent or about three
billion dollars in the last three or four years. That's about
1 percent of the market, so it's still a pretty small part
of the overall crop protection market. About 90 percent of
the total microbial sales are Bt's. So although there are
a lot of other products registered, they are still mostly
in the Bt area.
Just to note that none of the major crop protection chemical
companies, or the top six which have about 81 percent of the
global crop protection market, are in the biopesticide discovery
area. So although number seven, Sumotomo Arvalent, is in that
market, most of the Japanese companies now have gotten involved
in the biopesticide market. Sumotomo, Mitzui, Nissan and Arvesta
are the current global sales leaders. And, Pineapple, next
slide, please. To give you an idea of the estimated sales,
Sumotomo Arvalent bioscience is about 100 million dollars
and Mitzui Sirtus about 30 million dollars. So right away,
you've got two companies that have about half of the global
biopesticide market. And there has been a lot of consolidation
in that industry, as there has been with other industries.
If you look at the current number two company, Mitzui Sirtus,
it has a long history of products that have come from Thermo
Trilogy, WR Grace, Biosis, Crops Genetic International and
AgraQuest, and products from Norvatis, which came from Zilicon
and Santos, mainly the Bt products.
Emerald Bio Agriculture is a recent company formed by Oxine
and Mycotic. Valent Biosciences is a result of Valent purchasing
the Abbott biopesticide business. So there has been a number
of consolidations. But what I note in the next bullet point,
even in spite of the consolidation there is still probably
about 50 companies that are still involved in biopesticides
worldwide. Thirty some -- 32 or 33 -- and Harry will mention
in the Biopesticide Industry Alliance. So it's really to point
out that most companies are very small with sales of less
than a million dollars, and I think that has a lot of impact
on how these companies can survive and be part of the overall
process. And again, about 90 percent of the sales of Bt's.
Of the global market, the U.S. has probably about 100 million
dollars of that total. Europe with several countries there
-- France, Italy, Portugal and Spain -- also heavily use biopesticides.
And then Asian countries -- Japan and China -- are also very
I would like to just mention a little bit about how these
products are used mainly on high value fruit and vegetable
crops, both in field and greenhouse situations. We won't talk
about the plant incorporated proteins, as Janet mentioned,
but the fuller use of a lot of Bt's were really truncated
by Bt cotton and Bt corn and other crops. So there are some
markets that were taken away because the plants were expressing
the proteins rather than having them put on their plant surface.
Many of the products are not discovered by industry, but are
discovered in public institutions like USDA, ARS and so on
and are patented and licensed then to companies for development.
So I really put -- in that previous case, really products
are in search of a market or use, because a lot of these products
are discovered, but then the market potential hasn't been
defined. There are a few companies -- and I just mentioned
AgraQuest. It's not the only company. But some companies are
doing targeted screening for market targets. So there is a
little discovery work out there.
Just to mention a little bit about the IR-4 Program. We've
had one now for 20 years supporting biopesticide companies
to help them in the registration process. But even before
that, back in the '70's, IR-4 was involved in helping companies
to get the Foliar Bt's registered in the '70's and '80's.
Over the last six or seven years, we've supported over 2.1
million dollars over 140 projects through our biopesticide
research program to help -- through a competitive grant program
to help get these products out in the field and get the exposure.
As Janet mentioned, there have been several workshops that
we've been involved in. The most recent one was the NAFTA
Biopesticide Registration Workshop. Thanks very much to BPPD
and PMRA and California DPR for helping us co-sponsor that.
About 192 people attended, really a lot of interest in registering
of biopesticides, and we had people from NAFTA counties and
across the world. We have involved biopesticides in our food
use workshop discussions to try to get them considered mainstream.
And I personally have been involved as an ad hoc member of
BPI since its formation, and I'm now a member of their steering
committee. So I'm very supportive of that industry, and Gary
will talk about that a little bit later.
Next slide. Just to -- I'm not going to get into a lot of
the challenges when time is really pressing, but I know the
other speakers will. But I think an opportunity is to look
for USDA researchers and land grant university extension specialists
support for use of biopesticides. And I talked about IPM and
IRM. IRM is integrated resistance management programs. And
I think there are some great opportunities to use biopesticides
with the newer chemistries to help avoid resistance development.
I think there are a lot of opportunities, and hopefully this
group can start to address them to look at policy changes
and incentives to change behavior, attitudes and perceptions
of biopesticides and their use. I think there are some opportunities
to educate key influencers, researchers, extension agents,
pest control advisors and so on on the value of these products,
and really to demonstrate that biopesticides can offer cost
effective and reliable alternatives to chemicals, and again
especially in IPM programs.
One of the things that we're trying to do -- and you may or
may not be aware of it, because the initial publicity is just
coming out. But there is going to be a national IPM conference
coming up in April of next year in Indianapolis. Jerry Barren
on my staff is on the organizing committee, and we're certainly
trying to get biopesticides included as a major component
of that discussion. We have looked at increasing our funding
in our research program. And I challenge the industry this
year, because we actually were going to put another $100,000
in our research program, and we didn't have enough proposals
to fund. So I put out a challenge to university systems and
so on to make more requests for our grant funds. The biopesticide
companies, I challenge them to leverage their funding at the
university system with ours so that we can really get more
done with our combined funds. I think it's probably too late,
and I'm not sure whether there is any opportunities -- or
were any opportunities in the farm bill for biopesticide funding.
But I think that's an opportunity that should have been looked
at but wasn't.
And then finally, really look at possibly BPPD focusing some
more of their resources on biopesticide registrations. I know
there is always a conflict in all the EPA agencies to look
at how resources are focused, and of course there is the competitive
issue -- BPPD with plant incorporated protectants. We're looking
at sponsoring tours that focus on biopesticides. Lori Berger,
our panel member, is not here right now. But they organized
a California minor crops tour. We're looking at participating
in that tour this year with several sites that would focus
on biopesticide opportunities, and looking at sponsoring seminars
associated with these tours. And I think Gary may talk about
this more. The is an opportunity for BPI to complete their
standards and certification program so they can really promote
the effective use of biopesticides in integrated programs.
So thank you, and I'm going to turn it over to the next speaker.
MR. LIBMAN: Hi. I would like to thank first of all
the PPDC for allowing this excellent presentation to this
whole subject to be put to the forefront. It's very important
for us. And also to thank Kathleen and Janet for inviting
me for this.
What I'm going to be talking about is just an overview of
the Biopesticide Industry Alliance, BPIA, and then talk just
very briefly during my short allotted time about missions,
focus and goals, and then talk really what is the main subject
here today, which is the barriers to the market and breaking
down the barriers. If you notice the picture, that's just
a template from Power Point. But those mountains are not arbitrary.
That's my view from my home, and if we don't get biopesticides
on the market more, I'll have to give it up and go back to
(Laughter.) So it's very important for me. Next. Okay. So
who are we, the Biopesticides Industry Alliance. We are a
coalition of members of the biopesticide industry. There are
also ad hoc members, such as IR-4 which Bob Holm was just
talking about. We have representatives from USDA, the Forest
Service and a couple of regulatory consultants who do some
key work for us, too.
We have 32 voting members right now and seven ad hoc memberships
in the BPIA. And the criteria for the company is that greater
than 50 percent of the business has to be in biopesticides,
which is not to say sales, because in some cases there are
no sales for some of these small companies. But at least 50
percent of the R&D or some type of expenditure has to
be in biopesticides. Our mission is very clear. It is to improve
the global market perception -- global market perception,
not just the United States -- that biopesticides are effective
products, which they are. There is a commonality of thought
certainly from the past because of some products that were
not so -- or not very efficacious that some of these biopesticides
are snake oils. Well, we're putting together things to make
sure that that will not happen in the future. We also want
to help facilitate the successful registration process of
biopesticides. And really a third mission, which I didn't
put in there which is part of this thing now, is what we're
doing here today, which is trying to reduce some of the barriers
for the use of the biopesticides in the United States.
I just indicated the focus being two classes of biopesticides.
Janet Andersen was talking about her division, but we're just
part of that. We're just microbials and the biochemicals.
We do not get involved with the plant incorporated pesticides,
the PIPs. We are strictly involved -- we are not genetically
modified. We're strictly biopesticides -- microbials and biochemicals.
One of our key goals is to develop an industrial seal of approval,
which Bob Holm had eluded to, and we want to demonstrate that
biopesticides are effective and very high quality alternatives
to traditional crop protection products. And not necessarily
stand alone. In some cases stand alone, obviously, but also
to be used as part of the integrated pest management programs
-- I think that's very important -- and to weed out some of
these snake oils, if they still exist. We want to make sure
that they get out. So we want to have some type of a seal
We also want to develop -- and I believe we've been quite
successful in this -- a good working relationship with the
U.S. EPA, PMRA, Canada, the IR-4, certainly, the California
BPR and other agencies globally. We want to work also to disseminate
guidelines, policies and procedures to the industry and other
stakeholders. We had our first meeting a little over two years
ago and with about nine people. And we now have three meetings
a year, generally one in Washington. We've had one in Canada,
and also -- we also tried to have one in California as well.
We have five different committees, two key committees and
a regulatory committee, which I'm a member of, and we've had
regular meetings with BPPD, as well as PMRA and Canada, and
the California DPR as well.
Then we have the Standards Committee, which is working towards
a set of criteria for the seal of approval. And I feel strongly,
and I think everyone will agree to this, that we've had some
very open dialogues and discussions, and they have benefitted
all of us as well as the regulators. So what are the barriers?
Well, the skepticism due to snake oils and products which
don't work as promised. We have to make sure that we get rid
of those things, and that's what we're working towards.
Also -- and I'm glad there is USDA representation here, too,
because you're going to hear this several times. We need help
from the USDA. Right now there is a lack of grant -- land
grant extension specialist support due to the long successful
history of the chemicals. And also there is dwindling resources
obviously at the extensions, too, and the testing regimes
at the land grant universities tend to be over weighted on
stand alone silver bullet types of products rather than some
types of IMP approaches which is what our -- our products
fall into that nitch. The university testing protocols at
these land grant universities tend to be designed for chemicals,
and we need to work towards that, again with help from the
USDA. We have a very short time frame for development, and
because of that a lot of these products are launched without
the usual grower experience of years and years of people using
these products. So that's -- we're hoisting our own (inaudible)
in that. And we also -- there have been increasingly longer
time frames for approvals within the U.S. EPA and California.
It's certainly better than it has been, but there are problems.
And Janet can go into that, too. I'm not sure what the average
time is right now of getting through. Some of the fault is
our own fault, because the registrants may not do things correctly,
just like on the chemical side. But certainly there has been
an increase in the long time frames, and that is a concern
for us. And that's regarding Section 3's and Section 5's.
And the other thing is that we tend not to be considered as
alternatives to the Section 18's, the emergency exemptions.
So how do we break down these barriers? Awareness in forums
such as the PPDC. And our standards will be very important
to get rid of the snake oils. Faster EUPs in Section 3's with
help from Janet Andersen and her people to get products to
the growers quicker and without crop destruct, because these
are mostly products that have exemptions from tolerances.
We need help from the education incentives from the land grant
universities to support these biologicals. We need more USDA
dollars targeted to the adoption of biopesticides into these
ecologically based IPM programs. Thank you.
MS. KNOX: Al, you're next. Do you want the --
MR. JENNINGS: No, that's all right. Being this far
deep in the batting order, everyone has said everything already.
So I'll just break tradition and sit here. Besides, I only
get five minutes. I think when I hear barriers to adoption,
or barriers in an open marketplace, the question really is,
is there something wrong in that marketplace. Is it functioning
correctly. Is it functioning as we expect or is there, as
I said, something fundamentally wrong that government needs
to address. And certainly Bob and Gary have identified what
they see as a number of those issues that could be worked
on. And I think it is important to go back and point out,
as Janet did, that EPA has already intervened in that marketplace
by making entry into the pesticide market easier, quicker
and cheaper for the biopesticides, and certainly that provides
them with a great advantage. So I guess we're faced with the
question of, why aren't farmers using them in greater volume.
Back to basics. It seems to me for the most part, with the
exception of a few specialty growers, farmers really don't
care what their pesticide product is made out of. They don't
care whether it's biological, biochemical, organic, inorganic
or imported from Mars. What they care about is does it work
and is it cheap, or at least affordable or cost effective.
And that is ultimately the criteria that farmers will use
in deciding what products to use in this marketplace that
is fairly competitive. Of course, as was pointed out, they
also have to know that there are other products out there,
and that really involves marketing and sales. I come from
the midwest, Missouri, and this time of year on you're constantly
bombarded on radio and TV with ads for pesticides. I don't
recall ever seeing a biopesticide product advertised. We see
lots of conventional advertised. Marketing is critical if
you're going to get people to use your product. I think the
old adage of build a better mousetrap and the world will beat
a path to your door is true only if you spend 25 million bucks
in advertising these days. It's just not going to happen if
people don't know about your product.
It's also not going to happen if people don't have confidence
in your product and know you're there. Brand name recognition
and company recognition are important factors for farmers.
If this stuff doesn't work, where do I go. Who do I call.
Will there be somebody there who will come back and reapply
or someone who will reimburse me. Again, if we've never heard
of you before, it's going to be hard to make that connection.
Land grant scientists and extension agents have been mentioned,
that we need to do more with getting them familiar with the
products. And there are probably some things that we can do
there, because again, if they don't know about the product,
they can't really talk about it. Our specialists out there
don't really do pesticide recommendations any more, but they
will answer questions. So if you ask them, have you ever heard
of product X, they will be happy to tell you their experience
with it in their field trials or their small plot studies
and that sort of thing. If they've never heard of the product,
chances are they're going to say I've never heard of it and
I can't tell you anything about it. And that automatically
is a big strike against the product.
Who makes the decision? Again, we were talking -- or I was
talking earlier about marketing. Certainly farmers make the
decision in lots of cases, particularly in the midwest in
the row crops, but when you switch into fruits and vegetables,
70 to 80 percent of the fruit and vegetable production in
this country is under contract with processors or packers
and shippers. And in many cases, the farmers -- the growers
-- are not making their pest management decisions. And your
marketing target really has to shift to the processors, the
packers and that sort of thing, because they will be dictating
to the farmer what they can and can't use or what the preferred
products are. So, again, it's important to think about who
you're trying to reach. I guess finally, just in the area
of trying to start a fight, it seems to me that many of the
biologicals and biochemicals sort of start off as here's a
really good idea. It's kind of good science. It's good biology
or whatever. And products are put onto the market and then
they go searching for somebody to buy them.
I think you need to look at this the other way around. You
need to do your market research up front. Does the farmer/grower
have a need for something, and then can you create a product
that fits into that need that satisfies the need. Gives the
farmer/grower what he/she needs, and is it cost effective,
and does it fit in with the agricultural production process
as it currently exists. The pheromones and the little strips
that you go out and tie on apple trees and pear trees? A great
idea and it worked well, but it would have been accepted much
quicker if you could just spray it, because everybody has
a sprayer. And tying those little twistees on trees is a real
So again, I think looking at the market and looking at the
production system and trying to figure out where the product
fits are really fundamental in having market success. Am I
finished with my five minutes?
MS. KNOX: You are. Okay, fine.
MR. HOCK: Okay. I'm supposed to discuss the issue of
extension perspectives in relationship to microbial pesticides.
Now, Gary and Al already eluded to some of the issues, and
I just -- I think all of you know who extension is and our
clientele. Our clientele are the growers. Really the citizens
of the states that we represent. So in essence, my clientele
when I was at Penn State for 27 years, they were the growers.
They were the citizens of the Commonwealth. So these are the
people we have to interact with. And I can tell you, the cooperative
extension strongly supports the use of safer pesticides such
as microbial pesticides, insect/roach regulators, pheromones,
floral attractants and naturally occurring repellents. To
us, these are essential elements in a finely tuned integrated
pest management program. They're essential. But the problem
is, as I see it, it is often difficult to sell growers that
these biopesticides are as reliable as the synthetic chemical
pesticides that are most often used in their pest management
program. I think it's what Al said. They are familiar with
the chemicals. They're familiar with those synthetics. They're
familiar with those old reliables and that's what they will
go for. It is a matter of selling biopesticides to the grower.
As I mentioned, my 27 years at Penn State, I can't count the
number of times that I've heard grower say to me, you know,
I need something that is a good insurance policy against a
broad scale pest outbreak. A broad scale pest outbreak. In
essence, growers want a reliable insurance that their crops
are protected against a wide spectrum of pests. Many growers
have used the term or said to me, I just want to be able to
sleep well at nights. I want to get a good night's sleep.
I can't tell you how many times I've been told that.
Now, I see several problems to broad scale acceptance of biopesticides,
especially the microbial pesticides. Microbial pesticides
are usually highly specific to a single pest or a related
group of pests. Crops like apples, peaches, tomatoes, citrus
-- and I can go on and on and on -- are attacked by many different
insects and diseases, not just one or two. So even if a grower
were to use a microbial pesticide, the grower will almost
certainly use a synthetic chemical to control all those other
pests that aren't being controlled by that specific microbial
product. So they're still going to go to the broad scale product
that will give them that good night's sleep. Now, I mean,
there are certain exceptions. You all are familiar with Bt
or Bacillus Thuringiensis. It's a notable exception. It controls
a large group of lepidopteran insects. But there again, timing
is extremely critical. For example, we have a serious problem
with gypsy moths in Pennsylvania. If the grower -- or I should
say if the state. It's usually not the grower. But if the
state puts on the product when the insect is in the third
or fourth instar, it doesn't work. It's got to be put on early
for it to work. Timing is critical and that doesn't always
work. If you miss that particular critical stage of development
of the insect, you lose your ability to control that pest.
I personally think the insect sex attractants and mating disruptors
have probably had a more widely accepted -- or have been more
widely accepted by growers than the microbials. Pheromone
traps are rarely used to control a pest, but rather to monitor
the pest and alert the grower when it is time to spray. In
other words, here we go back to the issue. The pheromones
will tell the grower when to put on that reliable synthetic
chemical to give that grower the control that he or she is
looking for. This might work well with insects, but let's
take it one step further. What about fungal diseases? There
are very few micropesticides that really will give the kind
of control that a grower is looking for when you're looking
at plant diseases, whether they be fungi, bacteria -- well,
we don't have viruses anyway. But we really don't have products
that are reliable in controlling most fungi, so what does
a grower have to do. He's got to put on -- he or she has to
put on a fairly wide spectrum product.
As I said, Cooperative Extension supports the idea of using
microbial products or biopesticides in general. I mean, we
endorse this. We have it in our recommendations. Al, we still
publish in Pennsylvania ecommendations for tree fruits, for
small fruits, for grain crops and for vegetables, and most
of what we recommend quite frankly are the standard synthetic
chemicals. Very few biopesticides. Sure, we'll include Bt
where appropriate. But by and large, most of the products
are still the synthetic chemicals that the grower relies on.
The bottom line, Cooperative Extension has to give the grower
a wide array of options to choose from. We can't be biased
for one product or another. We include everything. But again,
most of the products that we include are the ones that are
out there, and they're the synthetic products. So again, growers
will adopt new pest control measures if they can be shown
to be effective, cost efficient and, again, if the grower
can get that good night's sleep.
MS. KNOX: Thank you.
MS.BERGER: Good morning. My name is Lori Berger, and
I'm going to be giving the grower perspective on the use of
biopesticides. You might want to -- would you make that a
little bit smaller so the rest of my boards fit in there?
Because I think my other slides are going to be as broad --
or as wide.
Anyway, I'm with the California Minor Crops Council, and this
mainly includes trees, vines, vegetables and so forth. But
I've been -- I'm an entomologist by training, and I am going
to be speaking a little bit on behalf of some field crops
-- cotton, alfalfa and rice -- that I have had some experience
in. But I've had the opportunity for this five minute talk
to be able to sum it on one slide. And if you could pull off
the little tab there, Pineapple, it all relates to efficacy,
efficacy, efficacy. Next slide, please. But I will expand
on efficacy. The current situation that we have with biopesticides
in our crops mainly boils down to one organism: Bacillus Thuringiensis.
Bt. There are a lot of pheromones used as mating disruptants
and bait and trap type of material. There are very few used
as frost protection material. We have them listed in our packet,
some growth regulators. But basically we've got one product
-- one main product -- and that's the Bacillus Thuringiensis
-- which in a lot of the row crops has now been built in or
stacked into the gene sequence of these plants. So we're mainly
looking at insecticides. So as consumers, the grower really
doesn't have a wide spectrum of these products from which
Next slide. Okay. What do growers want? They want efficacy.
They went a technical fit. And they would like something that
is broad, but these products tend to be very narrow in spectrum.
Consistent performance. They would like to have longevity
of control. They would like to work with products that don't
make their job harder in terms of labor. And some of these
materials and techniques are much more labor intensive and
they do cause people to be out in the field more. The example
was brought up about tying the pheromone ties up in the trees
or putting these new puffer devices out in the field. So at
lot of these do add a lot of labor cost. The materials --
growers want materials that are compatible with other IPM
tools and aren't going to have to make them apply more materials
because they're only getting efficacy on one test. They would
like environmental stability. And I believe that this is an
impediment to the use of these materials in places other than
California, because there are issues with rain. We don't have
that issue in California, unfortunately. But also UV protection.
These kind of things cut down on the life in the field of
these types of materials. And finally, growers do want a reasonable
Next slide, please. Okay. In general, what has the growers'
experience been? With Bt's, generally good efficacy. One thing
that I think is very interesting, and for you nonentomologists
out in the field, the way these Bts work, the Bt is consumed
and in the mid-gut of the larva a crystalline protein is formed.
And this basically gives the larva a stomach ache. Their mouth
parts are paralyzed. And so what happens is you have a larvae
out there, and if you're a scout, you actually see live larvae
out there. You don't get the satisfaction of seeing them dead
right away. So growers have had to adapt to the fact that
these things are not killed immediately. And that's been kind
of a shift in thinking with materials and how they work. So
they take a longer time to work in a field, and you need to
train people of what, you know, just a sick larvae looks like
versus a dead one.
More scouting is needed with these materials. We need backup
products in case the Bt does not work or the biopesticide
does not work. These can be labor intensive. And one thing
we have seen that was mentioned, some of the formulations
are improving. We've gone from tying up pheromones into trees
to sprayable formulations. This really helps out growers a
lot if they can use the equipment they have, or if they can
cover a wide area as well. Next slide. Where are the new products?
And I'm looking forward to hearing more about this. Through
FQPA we've been asked to transition two reduced risk materials.
The California Minor Crop Council has been in the process
of developing several pest management strategic plans. And
these are long range plans to help us move out of high input,
highly toxic materials to lower risk, and these are the crops
that we've been working in thus far. We've had IR-4 and EPA
participation at these meetings, and through all these meetings
we've only had one new biopesticide mentioned as part of a
possible solution to our growers' problems.
Okay. So the new product introductions, there is not a lot
of data. There is a perception that there are snake oils.
Technology transfer and support? Both the companies -- there
is not a lot of technical support in the field by the companies.
And in California specifically, we have fewer and fewer Cooperative
Extension people that can help us work with the more difficult
to work with product and show the growers how to work with
them. And this is an area where the expanded EUP could really
help us at the field level. Growers are being asked to take
greater risks, but they're not being rewarded for taking those
risks. When it comes down to a highly valuable crop, it's
kind of a no brainer. The growers need incentives. They need
to see these things in the field. Okay. So I want to say in
conclusion that growers are open to bio -- to new technology.
Efficacy is a reasonable expectation of these folks. They
will pay a fair cost, because they recognize the value of
these materials. They want choices. They want more than one
product. There is not a lot of things coming through the pipeline.
We need technical support from both the companies and from
Cooperative Extension. And we need on-farm incentives to help
us to reduce -- to transition to reduced risk.
MS. KNOX: Thank you, Lori. Steve?
MR. BALLING: First of all, I want to thank Pineapple
for turning up the lights. I thought I was going to have to
start my second half century of life with cataract surgery
or something. I was struggling seeing anything, so thank you,
Pineapple. Five years ago Del Monte tested a revolutionary
new product on some snap beans in the midwest. This product
was meant to not only control European corn borer on snap
beans, but also to control white mold. It sounded pretty exciting.
So we ran it through tests that were provided to us -- the
protocol that was provided to us by the company -- and the
results were really interesting. They were statistically worse
than the untreated check, which suggests that in fact they
were attracting insects and disease instead of controlling
them. Obviously that's not hopefully a common occurrence with
most of the biopesticides, but you can imagine that it does
tend to shake confidence occasionally. This is not new. There
is a history of these kinds of experiences which we battle
all the time.
Nonetheless, as a processor who wants to minimize pesticide
residues in our foods, we are constantly searching for opportunities
-- options -- for biopesticides to work in our programs. And
in fact, I would argue that so are our growers. And I might
disagree with Al to some extent. I certainly understand the
economic issue, and certainly for growers who are teetering
on the edge, economics are pretty critical and efficacy obviously
But they do want to move to softer chemicals. It's a better
program. You would rather have that on your land and be able
to send your workers in it any time you feel reasonably safe,
including you and your own family. So not unusual. One of
the things I would like to state, though, if you look at this
list that BPPD provided, I have 197 biopesticides.
(End of Tape 1, Side B.)
MR. BALLING: -- coming out all the time are very exciting.
But it's still a much smaller population of real usable products
than we think. It's not 197, and for that reason then, let's
not think that there is a lot of failures out there. We're
looking at a fairly small world yet, and a growing world that
Del Monte -- in vegetable crops we do our own applications,
so we have to work with about 90,000 acres of peas, beans,
corn, cabbage and spinach around the U.S. And we're constantly
trying to test new programs. But in that testing process,
we require a couple of things before we'll get a new compound.
It has to -- it has to not be a numbered compound in the context
of conventional chemicals, but at least be a registered compound
in the context of biopesticides. It has to have some replicated
data that we can look at and say it's worth our effort to
go in and look at that product. And it costs us about $1500
a replicated test to look at a compound, so it has to be worth
the effort. One of the areas in which biopesticide companies
have fallen down is that they don't have that replicated data.
They rely on grower anecdote and that doesn't work for us.
I mean, it's just too expensive for us to go in and try to
spend three years working on a new product if we're going
to base it on anecdotal material with pictures of, you know,
fields next to each other. We've done it. I don't deny that.
But we tend not to.
When it is commercialized, there are some serious barriers
to commercialization. Some of these have been discussed. We're
working at 90,000 acres. We have to be able to apply this
typically by air, because we're on an IPM type program and
we make snap decisions. We only make applications where we
have to. A lot of these products are not helpful in a large
scale situation. Tank mixes are cost effective. It's expensive
to make any kind of application. You can't tank mix. A lot
of these products are difficult to tank mix. Dealers drive
adoption in the fruit crops, and many of the dealers have
not yet adopted this, so that's the exposure issue for a lot
of folks. There are often novel problems. Kaolin clay in pears
and apples are being used somewhat extensively up in the Wenatchee
Valley area in Washington state, but they end up with little
white dust in the cracks and crevices of the apple and it
doesn't look good. And so you've got a fundamental problem
with how they're going to keep those things clean.
When growers are teetering on the edge, they tend to look
for things that are as effective as possible. And one of the
real interesting ironies of this whole situation with biopesticides
is that as new compounds -- or new biopesticides come out,
the only growers who tend to look at it are the biggest growers.
The ones that have the available land and available capital
and the willingness to try something new. Our smaller growers
typically can't do that. And then so the irony is here we're
trying to support family farms and smaller farms and worry
about consolidation. But they're the ones that relied most
on conventional and had the most difficulty adopting. At least
in a more conventional kind of situation the most difficulty.
All that being said, I would just like to say we will continue
testing. We think there are still wonderful opportunities
out there. Hopefully what I've given you is the historical
context for the barriers and not a future context. Sell it
on REIs at preharvest intervals, because that's where the
sell will be. Thanks.
MS. KNOX: Carolyn?
MS. BRICKEY: Yeah. I guess I don't want to repeat anything
that has been said so far, and I probably don't need to, because
I'm going to talk mostly about the outlook for organic farmers
in using biopesticides.
First of all, if you think about everything you know in the
conventional world about resources, about networks, about
knowledge bases on these materials, you take that and divide
it by a thousand. So we're talking about a small resource
base. We're talking about small farmers. And you're talking
about a much smaller knowledge base about these materials.
So that you've got to accept and understand. You're also in
terms of scale dealing with a lot more small farmers than
you are in the conventional setting, obviously, and you're
dealing with a group of growers who don't fit into traditional
pesticide networks. Groups like this. They don't work with
the dealers primarily. They don't -- you know, they're not
involved in EPA activities. Many of them don't -- are not
active in commodity groups, although that is starting to change,
I think, which will be helpful. And you're obviously dealing
with people that are working on fragile margins economically.
These are people who primarily are not knowledgeable about
the pesticide registration process. So the fact that EPA issues
a press release and says hey, group, we're, you know, registering
this new biopesticide, that wouldn't penetrate the groups
that I'm talking about. And, you know, that's all pretty much
bad news. Let's face it. But we have some good news. Here
it is. We have a new rule that is going to become final in
October. October 21st to be exact. That is going to focus
a lot of attention on the organic marketplace. Not all of
it favorable, but most of it I think will be.
And as part of that process, I've just completed a five year
term on the National Organic Standards Board, the last two
years as Chair, in which we were tasked very specially with
the role of reviewing materials that can be used in organic
production and recommending to the Secretary of Agriculture
which of those materials should be placed on what we call
the national list. And we certainly involved Janet Andersen
in that process and also Jim Jones to work with us on educating
the folks in our community about how the registration process
works. How we can analogize to the registration process in
terms of the work that our Board had to do and is doing to
look at these materials. Just one interesting piece of information
I can report. I've just come from a meeting of the Board in
which Spinosad was recommended to the Secretary to be used
on organic crops. So it's a different world. But in some ways,
the world is getting -- that world is getting closer to this
world. Much of the history of dealing with these materials
as in the conventional world is trial and error, and that
does not lend itself to a dynamic marketing situation, as
you know. More good news is that there are some very well
known networks that are dedicated to organic production that
both this group and the new trade association can work with.
And I would be happy to talk more about that process off line.
When Janet called me -- I guess -- I don't know when this
was, Janet, maybe a year ago -- and said this new group had
formed, I have to admit at the time I thought, well, okay.
Now, I see some real value in working with that group, and
I see why you were excited about the formation of it. Working
obviously with the Organic Trade Association is one opportunity.
There are trade shows -- there is one going on in Austin right
now -- where these products can be talked about. However,
I think it would be really important to follow up on what
Steve said about the universe and materials we're talking
about. If we're really talking about 30 materials or 40 materials,
if we can match those up very specifically to the uses that
they are available for and would be recommended for, I think
that's the way to approach the organic community. Seeing this
list that you've given us, which is of course just for informational
purposes, would be a daunting list for a grower to look at
it and say well, I don't know what this means. What are these
things. So I think really connecting those viable products
to their uses and educating the organic community about it
would be valuable. And, you know, I can offer a lot more suggestions
about that when it is appropriate to do that. Thank you.
MS. KNOX: Thank you, Carolyn. Now, we started a little
bit late, but we, I think, made up part of the time. Maybe
if we just take the next 15 minutes, and if anyone else has
any additional barriers, constraints or issues that they want
to raise, and then after lunch we'll try and talk about potential
solutions to the issues and barriers.
FEMALE SPEAKER: This is just a quick question,
I guess. A lot of the reservations that I'm hearing about
introducing biopesticides into a wider market -- a more feasible
market -- I think apply to introducing any new pesticide or
chemical. There are market issues. There is cost. There is
how widespread it is. There is nobody has ever heard of it.
There's maybe not enough testing. Your neighbors never used
it, blah, blah, blah. And I wonder if we couldn't have this
same conversation, but also in the context of an integrated
pest management, so that it was the kind of more feasible
conversation in line with the long term goals of the EPA in
terms of introducing more integrated pest management strategies,
so that the bio sides fit in with conventional chemicals in
their role, bio sides in their role, no chemicals or organics
in their role.
And that might not be for whole farmers, but it might be for
periods or for seasons or for weeks so that we don't need
a constant barrage of chemicals on the crops. And then also
with tilling and with rotation of crops and things that we
know about, so that in a more integrated conversation, these
bio sides might be more feasible and have a role.
MALE SPEAKER: In fact, one of the things that I think
is that some of the successful microbial biopesticides have
been used in IPM programs in part, because I think cotton
probably would be one case where they look for the use in
an earlier season. I think some of the vegetable crops as
well. So I do believe that they are being integrated into
IPM programs, and I would say -- earlier I think I heard the
statement that really no insecticide is a stand alone. They're
all part of programs, and if you are managing it properly,
I think they do qualify as IPM programs in that respect.
But one of the things that -- I guess that I take some exception
to some of the things that I heard is that -- the perception
that there is not an active interest on industry's part to
try to bring some of these to market, even at the larger companies.
And I say this from experience, because for four and a half
years I worked in product development on five different biopesticides
trying to bring them from basically a laboratory setting to
market. And any of these are still subject to the biology
that underlies them. As with any successful product, you're
looking for something that is going to work reliably time
and again. So what you have to look at in that respect is
efficacy is not only a one time situation. But it goes back
to the risk whether or not it's going to give you the intended
control or management often enough that a grower can rely
on it, and if not, what is their backup to come back in for
a rescue treatment if the biological or the bio control method
doesn't work. So I would say that I'm aware of a number of
programs that were ongoing several years ago. I've been out
of this for a number of years now. But in looking at it, where
the research can take place and where it is taking place,
is often at a very basic level. (Tape malfunction.)
MALE SPEAKER: -- come up with something. Once they
come with a product that looks promising, it often is then
looked at by larger companies that might be able to have the
background to bring it to place. So again, I think they are
part of IPM and that's a wonderful place to consider it. And
secondly, there is, in my perception, very much an ongoing
effort to look for them and to try to commercialize them.
The lack is just a matter of giving it enough opportunity,
with exception of, say, the Bt's. And I would make one other
comment on the Bt's. They're actually not one product, but
at least three, and I would say some would say there are four
different subspecies of Bt's that act very differently from
MS. KNOX: Thank you. John, Shelley, Julie and then
Dan, Ray and Larry. And then I'll see how many others are
MR. RICOR: Yes. Good morning, all. John Ricor here.
I just want to follow up on some of the opportunities that
were mentioned earlier. I think Lori referred to the need
for incentives at the farm level, and I believe Robert talked
about the farm bill and looking at what the opportunities
might be there. And since Al is here from USDA, I would just
ask you to maybe characterize the opportunities there. I believe
there is a lot more funding for EQIP in the new farm bill
and that's probably where the opportunity lies. Even if there
is no specification for biopesticides, obviously it would
just fall under innovative pest management and integrated
weed management. And, of course, that means there are opportunities
for us to make sure that the way the rules are written, both
at the national and then each individual state, that there
is a little bit more emphasis on biopesticides.
If you could address that.
MALE SPEAKER: You're correct. I guess the Senate passed
the farm bill, the conference version, yesterday. I think
EQIP went from a billion to nine billion -- are those numbers
about right -- with it being a 60/40 split between animal
and other ag. And there are a lot of challenges trying to
figure out exactly what that means and what the money can
and should be spent for. That will be addressed. But certainly
the whole idea of how you get whole farm management systems
in place that have less impact on the environment is really
fundamental to that program.
MS. KNOX: Shelley?
MS. DAVIS: I had a question, because somebody mentioned
that cost was a big factor and that's obviously understandably
so. I was wondering if you could give us some examples of
how the more widely accepted biopesticides, like pheromone
disruption or Kaolin Clay or something like that, would compare
in cost to conventional approaches, and whether you see these
costs coming down in the near term.
MR. BALLING: Actually, it has been disappointing that
the costs haven't come down more. In pears, we've been looking
at mating disruption for about 10 years now. And the figures
in the early 1990's were three applications of goothion typically
cost about $60 per acre. Two applications of pheromones being
tied, including labor costs, were around $260.
Now, if you make four or five hundred dollars an acre off
of pears, and you sink $200 more in a pheromone program, and
then may have to spray early on with one application of goothion,
it gets pretty expensive and you lose a significant portion
of your profit. What most of our growers have gone to is a
single application of pheromones and a single goothion application
that seems to work. We're very anxious to see how sprayable
pheromones may turn out, because we think that might put us
in a much more cost effective situation, particularly because
of the labor issues and depending on how long those sprayables
work. So those numbers could work out quite well, and I hope
bode well for the future of sprayables -- or of pheromones.
MS. KNOX: Julie?
MS. SPAGNOLI: I think when you're looking at -- you
know, we talk about biopesticides and conventional synthetic
pesticides. I think one of the things that needs to be recognized
is how biopesticides actually have a role in the development
of new synthetic pesticides. And in many cases, there may
be a biopesticide or chemical that has some shortcomings,
and a lot of new chemical development is developing synthetic
-- basically synthetic versions of a biopesticide that maybe
overcomes some of the shortcomings.
And I can think of one example, you know, that we were involved
with, which was the new insect repellant, where they actually
analyzed the molecular structure of a number of natural repellant
chemicals, such as Citronella or the Eucalyptus, and determined
the mode of action. And then they actually designed, you know,
through molecular modeling to develop a molecule that had
the benefits there. And, in fact, enhanced some of the benefits
of that chemistry and overcame some of the shortcomings, so
that you actually ended up with a molecule that had a better
-- was better toxicologically and better efficacy than the
natural version. And so I think one of the -- you know, do
we need to look at the role that biopesticides play also in
the development of new synthetic chemicals. And I think you're
seeing that a lot of new development is based on trying to
improve on, you know, the natural versions.
MS. KNOX: Dan?
MR. BOTTS: I would just like to jump in on one issue
on the restraints or constraints on adoption of biopesticides.
And it's a historical perspective, but it seems to be repeating
Going back to my initial exposure to biopesticides was with
the introduction of Bt's in the vegetable crops back in the
late '60's and early '70's, where there was a tremendous education
curve to get growers to understand the mode of action of a
product. How the test worked. What it took to make the appropriate
decisions to be able to use that product effectively. Those
compounds went through the various iterations. There are at
least five different races of the Bt toxin that were developed
and targeted in the specific markets that we find into efficacy
levels which made them at least as effective as most of the
grower standard, hard synthetic compounds at that time. And
that educational process took a while to get done. It's not
something you snap your fingers and do. Just because EPA deems
it as a biological pesticide and registers it doesn't automatically
mean everybody in the marketplace knows it is out there. It's
a better mousetrap and it works.
I think we're facing truncation of the educational process
to allow the growers to adopt these products. And I go back
to the classic example of one of the items that Janet put
up on the screen as one of the new areas that they were looking
at that they were very enthusiastic about. And I don't want
to call it by name, but it is a situation where we were actively
engaged before that product ever came out of the laboratory
to go to the field to look at it because of its abnormal mode
of action. We were promoting that development into our conventional
commercial systems. There were indications that the efficacy
was there, similar to what Steve was talking about on some
of the compounds he has looked at. We encouraged the company
to go through the traditional university system route to do
the testing and to get the replicated trials to give us a
basis of comparison into the standards that were there. They
did some of that.
They got registration because of an expedited review and all
of a sudden it became the greatest thing since grits. It was
going to be used in every crop site known to man, and was
oversold and over marketed by the company. And all of a sudden
-- when it actually reached commercial fields and it didn't
live up to the hype and the perceived standard that was out
there, all of a sudden the whole group of compounds that were
being developed around that particular system all of a sudden
has a black eye. That doesn't work to anybody's advantage.
And part of that is because of the licensing process, and
the fact that you've got start up companies that are sitting
there. They have venture capital behind them trying to drive
a marketplace, the initial leverage offerings and public offerings,
and all of a sudden have a bunch of people they have to answer
to. And sometimes reality, because they don't have the basis
of information because it's been pushed so fast, to make the
transition to the marketplace it needs to be. So there are
issues on both sides of the process.
But I would like to emphasize something that Lori said. If
a product works, our growers will adopt it, even if it's not
100 percent efficacious, if it fits into a program that minimizes
our need for other pesticides. If it's efficacious and it
fits into our program, we'll use it. We're not going to go
out there and redesign a total production system that has
got a three to $4,000 cost per acre before you ever harvest
the crop, and another 3500 to $4,000 in harvesting and packaging
costs at the end of the day, just to fit a new product because
EPA says it's a new safer product. If it fits into our system,
we'll be glad to put it into our program. So you need to talk
-- in addition to the regulatory community -- USDA -- you
need to talk to the growers as you go into product development.
MS. KNOX: Thank you, Dan. Ray, then Larry and then
Gary, and then I think we'll have lunch.
RAY: Much has been said about the marketplace, and
I think the marketplace works very well. If your product works,
they'll buy it. The point was made earlier that none of the
major crop protection companies are involved in biopesticide
development, and I don't think that's strictly true. At least
a few of them have in the past had very active programs looking
for biopesticide products. And Burleson Smith mentioned this
from his previous experience in such programs.
Some of the issues that they come up with, or difficulties
they come up with involve, you know, a number of factors.
Manufacturing costs are typically -- can be much higher if
you have to deal with fermentation technology. There are a
number of efficacy issues. Some of the fungal products generally
are affected by weather conditions affecting their efficacy
such that they're not consistent. There are quite a number
of formulation issues. Some of these products are environmentally
unstable. They need UV protectants in the formulation. And
getting inert ingredients approved can be very expensive.
They may require multiple applications p-- that has been mentioned
-- whereas the alternative -- the competitive conventional
products get by with fewer applications. Rain fastness, because
the product must stick on the leaf to be active. That can
also be a concern. The major companies individually test tens
of thousands of chemicals, perhaps more each year, in looking
for viable commercial products for pest control. They're not
going to leave any stone unturned in finding those products
that have --
RAY: -- intellectual property protection. It takes
a great deal of investment to --
RAY: -- when you're dealing with natural products,
you may have --
RAY: -- intellectual property --
RAY: And as Julie mentioned --
RAY: -- natural products can become very effective
pesticides. And so there is going to be a lot of research
into the natural products in order to find those that can
be adapted. The synthetic pyrethroids are an obvious large
example of what started out as a natural product and had been
derivitized to make them more effective to overcome those
shortcomings. The incorporation of the Bt proteins in genetically
engineered crops. While we're staying away from genetically
engineered crops in this discussion, they all start out as
Spinosad was mentioned, and that was certainly developed by
one of the major companies. I remember in graduate school
looking through some very old literature and coming across
the chemical structure for a fungal pathogen which looked
quite familiar. And so I looked back through some other --
RAY: -- put in a single --
RAY: -- herbicides. And I've always wanted to follow
up and see if that was where it was found. So the natural
products do become sources of the chemistry that are developed
into a conventional pesticide.
So there are barriers. I think the products that are found
simply need to be competitive. And the major companies are
going to be involved in that and aren't going to leave any
stone unturned in finding good products.
MS. KNOX: Larry?
MR. ELWORTH: Thanks. I just want to say a little bit
about this issue of Extension. I think the role of Extension
is involved from direct involvement with growers to providing
education and information to a wide set of people. So I think
-- well, there is only one way to say it. Extension is not
going to get any more money. I mean, with all due respect
to Extension. And I was a client of Win's for a long time.
So if the balance --
MR. ELWORTH: -- biopesticides or any pesticides on
huge infusions of resources --
MR. ELWORTH: I mean, I'm sorry. I know this is a shock
to you, Win.
MR. ELWORTH: So in that case, if the role of Extension
is in information education, then implementation is going
to have to happen at the private sector level. And I didn't
hear a whole lot about interaction with either PCAs or private
consultants. And I think in terms of implementation as the
primary market or knowledge about the availability and efficacy
of any materials, particularly biopesticides, that's an important
linkage to make, which I didn't hear much about. I think not
having those people either aware of or well versed in using
those materials is a huge barrier. And the other thing I would
point out is that to the extent that there are regulatory
barriers for --
MR. ELWORTH: -- and conventional materials, they are
the same, except slightly more intense, or maybe a great deal
more intense, for the companies that register biopesticides.
And I know, Janet, you and Kathleen are very aware of this.
Examples that I'm most familiar with recently is with pheromones,
where people have -- and Steve mentioned it -- the advantage
of a sprayable pheromone over hand applied pheromone. It could
But all of a sudden, small companies who had never dealt with
tolerance issues, because now there are residues on the trees,
or at least concerned about residues on the trees, are dealing
both with tolerance issues and inert issues that they've not
dealt with before. Everybody has to deal with that. Julie's
company has to deal with that. For these companies in particular,
they are not over capitalized, so delays in registration can
actually do in the material before it actually gets registered.
In addition, they have relatively limited regulatory steps.
So I would just make the same argument that I'm sure the other
companies -- that companies would make as well, that understanding
what the regulatory requirements are and having them clearly
set out as soon as possible. When things are changing, to
provide information so that companies can anticipate the changes
and develop the data in time for the agency to use them. All
of those are important for any company getting a new registration
or tolerance, but especially true for these companies. And
for a lot of these companies, if you can't -- if you can't
work through the regulatory system pretty quickly, either
your venture capital or your support within the company, I
would assume, would dry up fairly quickly.
Finally, I would just make an observation, that where these
materials work well and are adopted well, it's basically where
they get a key pest, whether it's codling moth or any of the
pests of the major crops. Where you get a key pest, you have
a market incentive to use a new material, and that's where
these things tend to be most successful.
MS. KNOX: Gary and then Bob Rosenberg wants one little
minute after that, and then we'll have lunch.
MR. LIBMAN: Just two things. Number one, we talked
about the financial thing. We talked about the fact that there
is not a lot of money to advertise, because most of these
companies are small companies. We're really right on the brink,
to say the least. Bt's are successful. Bt's were -- and I
worked for Abbott Laboratories for 23 years. Abbott Laboratories,
Sandos and the big pharmaceutical companies put money aside
for the Bt development, and that's why it became so successful.
These companies and as part of this BPIA, we don't have that
kind of funding. And it is a problem. It continues to be a
The other thing -- and we heard an example. There are always
examples that my microbial don't work. And I'm sure there
are chemicals that don't work, too, and people don't say well,
therefore, chemicals don't work. But I think there is a tendency
that this microbial didn't work. Maybe all microbials don't
work. And we have to make sure we don't get into that negative
thinking. And I know you don't feel that way. The other thing
is, we're talking about insecticides. We need to also talk
about the biochemicals -- the plant growth regulators. Those
are quite successful. They're quite efficacious. Anything
that has gotten registered certainly within the last five
years in California you know that there is a tremendous amount
of efficacy data establishing that it really works quite well.
So we're not just talking about insecticides here. We're talking
about fungicides and the plant growth regulators.
MR. ROSENBERG: Understanding that everyone knows that
as long as I go they're being deprived of their lunch, I'll
just say one thing. In the area of nonagricultural use of
biologicals, which there are quite a few, the single biggest
deterrent or barrier to wider use is the inability of PCOs
to advertise the fact that they're providing a less toxic,
safer, healthier service or something that is different than
a conventional service.
And while that's not an EPA issue, if a pest control operator
uses reduced risk products, or lower toxicity products, or
biologicals, they are typically prevented by State Attorneys
Generals from making any health, safety or environmental claims
about the type of service they provide. If you can't say that
you're providing a different type of service, there is virtually
no incentive for trying to provide it. So to the extent that
the agency might want to once again take another look at that
issue, which it last did back in -- I believe it was 1992
when it adopted draft lawn care advertising guidelines, which
though they were never finalized have been taken as gospel
by State Attorneys Generals, that might be a worthwhile endeavor.
MS. MULKEY: Well, let me take a moment to thank
this panel for incredible time management, a rich dialogue
and giving us something to think and talk about over lunch.
Because they plan to come back and use their remaining hour
to work through some practical meaningful next steps. And
I've formulated in my own mind a few sort of thoughts from
an EPA perspective. Questions to pose, which I'll either talk
with Kathleen about or take the opportunity to do so that
we can get the most useful advice from you.
But I really invite everybody to spend time with each other,
and inside your own head working toward the hour that we anticipate.
We -- you guys were amazing. So we're able to come back from
lunch at the planned 1:30, which is a nice ample lunch hour.
But what you need to give us is to actually make it back exactly
at that time.
Thank you. (Whereupon, a lunch recess was taken.)
MS. KNOX: -- really talk about any thoughts or any
ideas about what either EPA can do, what the industry should
do, what USDA might be doing, what land grants or whatever.
Again, brainstorming is fine, but certainly practical solutions
would be nice, too. And then we'll go back, take all that
input and report back to you on it and try and identify some
things that we think might work. It may be short run or long
run. So that's the plan. Hopefully, we'll have a real good
discussion. As part of that, what really should EPA's role
be. What should USDA's role be. Not just what can any group
do, but what should the role be. Is it our role once we've
registered them to have further support in some way, or is
it sort of, you know, they're registered now. It's up to other
parts of the community.
MS. MULKEY: If I may just in order to frame
that question while Kathleen goes to -- a little bit more
with regard to asking your advice to us. In particular, anything
that you may want to suggest about the aspects of our registration
activities, anything particular to EUPs, anything particular
to analysis, or anything particular to priority setting in
this arena that you want to put forward, we're receptive to
hearing in this area of biopesticides.
And also partnering. What kind of partnerships can EPA engage
in and how in a meaningful way. So those are some things.
Al, is there anything you want to frame in terms of advice
you would like to hear on behalf of USDA?
MR. JENKINS: No, I don't think so. I think it's pretty
wide open. There have been lots of good ideas, so reinforce
some of those, if you please, or expand upon them.
MS. MULKEY: Okay. Janet, are you --
MS. ANDERSEN: I'm ready.
MS. MULKEY: I think you've got Steve and Gary and Ray
MS. ANDERSEN: All right. Well, let's start with Steve.
MR. BALLING: Good. Actually, one of the reasons --
I think maybe to help set the stage here -- and, Marcia, you
actually spoke to the issue. It's really kind of a process
issue. Julie had mentioned and got me thinking about this,
about all the synthetic analogues there are to biological
compounds. Spinosad is a good example. There are a lot of
MS. MULKEY: Pyrethroids.
MR. BALLING: Pyrethroids in general. So is the same
level of -- I've always made the assumption that the biological
pesticides are in fact safer, because they're biological,
right? But the scientist in me says, well, gosh, you know,
there are a lot of unsafe biology out there fairly self evident.
Are the biopesticides subjected to the same level of tox requirements
and those things so that in fact we can safely say that, yes,
they are safer products? That's sort of a basic question,
MS. ANDERSEN: Well, let me divide it into two groups:
the biochemicals and the microbials. There are -- in case
you don't know, there are a set of data requirements in part
158 of the regulations that we work under. There is a set
for conventional chemical pesticides, a set for biochemical
pesticides and a set for microbials.
With microorganisms you're asking rather different questions
than you are for chemicals, because these are things capable
of reproducing in the environment, first of all, so that makes
them inherently different. And second of all, the question
we more often ask is not toxicity, but insectivity and pathogenicity.
So considering that, it's a slightly different question that
you ask with a microorganism. But, yes, they are subjected
to a set of tests. We don't have a carcinogenicity test for
a microorganism. But for a chemical -- biochemical pesticides
it's a tiered approach. If you can go through the first tiers
and you reach no toxic endpoint, then you don't have to go
on to the other tiers. But the tier is set up such that you
can go all the way to requiring a full two year feeding trial
for carcinogenicity or whatever else it is you might need
if you have a biochemical pesticide.So they can be, but with
a tiered approach you don't have to ask for all of the same
data for baking soda that you do for some of the others. And
with resort to -- you know, if I talk about Spinosad and the
history of it a little bit, it did come from a microorganism.
If the company had come in as they started out with a microorganism
with BPPD, it would have stayed with us there. But when they
refined it and made it a chemical pesticide, it is toxic to
the target pest. It therefore fell outside the definition
of a biochemical and it went to the Registration Division.
And indeed, there were toxic endpoints to that product as
they went forward in the registration process.
MR. BALLING: And presumably there would been in the
natural compound as well?
MS. ANDERSEN: There might have been. We never got that
MR. BALLING: And you would have discovered that, presumably?
MS. ANDERSEN: We would hope that our tests would pick
that up, yes.
MR. BALLING: Okay.
MS. ANDERSEN: My next one on the thing is Ray.
RAY: Well, my question was very similar, so there's
just a little bit to add to it. You know, we have to be careful
about those potential tox concerns. We don't want to discover
the next nicotine the wrong way or the next cocaine.
I'm a little confused by your describing a nontoxic mode of
action. Except for return, I don't see how that is a proper
description, because if you're going to kill the pest, it
has to be toxic.
MS. ANDERSEN: Many of these things don't do it by toxic
mode of action. They might suffocate the pest. Now, to the
insect that may feel just as bad as if it was done by a toxin.
But it is a different mode of action.
Gary, you're next.
MR. LIBMAN: Also, by the way, the biochemicals usually
are not insecticidal or the plant growth regulators.
MS. ANDERSEN: Right.
MR. LIBMAN: So there is nontoxicity there as well,
at least to the target organism, we shall say.
Two things that came up over lunch, and some people kind of
cornered me and asked me a little bit about the certification
program of the Biopesticide Industry Alliance. What we're
trying to do is set up some standards so that when it meets
these rigorous standards over a two year time period out in
the field, that when -- you know, if there is some kind of
seal of approval or whatever we decide to do, that people
will be pretty well guaranteed that that is a very efficacious
type of product and we can eliminate the problems that people
have seen in the past. And in fact, the newer biopesticides
coming on the market, you're seeing really good efficacious
products. And obviously as you know, in the case of public
health type of products, they have to go through efficacy
trials within -- I mean, they all have to have efficacy data.
But it's required to be submitted to the U.S. EPA for public
health products. One question that we were talking about a
little bit is -- and maybe you can all help me on this one.
We would like to know in the biopesticide industry what we
can do to help independent crop consultants. Would a web site
help? Would a listing help? What can we do so that we can
help get the word out?
I didn't go into -- there is a survey that we're doing right
now. Some of the people in the Biopesticide Industry Alliance
have commissioned a survey. And I can't go into the details
of it, other than to say that in the PMCAs of places like
California or Florida, we're finding that just about half
of the people have no awareness of biopesticides at all. They
just don't have an awareness, and that's the single biggest
barrier to our products. They do not have that awareness.
And that was brought up very well from Al and so on. And another
issue. We're not as high a percentage, but there's also the
cost. We talked about the cost. The costs tend to be a little
higher until you can get things like the Bt's when you get
the fermentation process down pat, and you get these things
to be almost commodity types of products rather than specialized
ones, if you will. But we would like to know really what we
can do. What we can do to help these independent crop consultants
or PCAs and so on.
MS. ANDERSEN: Marcia, should -- just a word of -- Marcia,
would you like me to ask Lori, or do I wait until it's her
turn? What is the typical protocol you use in these meetings?
MS. MULKEY: Well, I think that's the kind of an open
ended question that as you get around to it, we'll get it
answered. Or if not, we'll come back to it.
MS. ANDERSEN: All right, great. Win -- I have Lori
on the list. So Win? Win is next.
MR. HOCK: Well, I would like you to address the education
issue. In fact, this kind of goes along with what Gary was
raising the question. What can you do to promote or at least
make people aware of your products? I don't think it's EPA's
position obviously to promote a biopesticide any more than
they should promote, let's say, a synthetic chemical. But,
you know, there are a lot of educational institutions out
there that can do that. You know, in my own position, I can
go back many, many years. I would get information on pheromones
and possibly on some PGRs and IGRs. But, you know, most of
the products -- most of the microbials that came out, I never
saw anything about that. I mean, we just didn't get the information
even at the university level.
Your comment about -- or your question about a web site. Yes,
that would be helpful. But if we're going to promote -- if
we're going to encourage growers to use these products, to
use microbials or at least think microbial -- I don't say
they're going to use them, but at least think about it. What
they need to do is have information. And how do they get information?
They can get it through Extension. They can get it through
their state lead agencies -- the regulatory agencies. You're
right. They can get it through private consultants as well.
Pest management consultants. Obviously, you've got to reach
out to those people. But I think part of the problem, at least
that I've experienced, I don't think the industry -- and I'm
talking here, you know, biopesticides, if you will. I don't
think there has been an outreach program to really get to
the key players to promote or at least encourage growers to
think about these products. So again, to me it's education,
and I just feel very strongly about that. If you're going
to have people become aware of the product, you have to have
a mechanism to get the word out. And it's an educational process.
MS. ANDERSEN: Okay. Thank you. Christine? Christina?
Is that the right -- I'm sorry.
MS. BEAR: Chris is fine.
MS. ANDERSEN: Chris, okay. I can do Chris.
MS. BEAR: I had a question more on the tier one --
or the tiered approach for toxicity testing.
MS. ANDERSEN: Uh-huh.
MS. BEAR: I guess the first question is, how does that
work? I mean, my interpretation of what you said is that if
you would do something like acute high dose studies and you
didn't see problems there, then you wouldn't go on to more
chronic studies. And so the specific question I ask is, what
is the criteria for an effect? I mean, if you don't see anything,
or if you see something but you determine that it's not relevant
or it's not appropriate to justify further testing? I guess
I'm sort of wondering how that interpretation is made that
this is where we stop. And the second part of that is, do
you have any idea when the endocrine disruptors screening
program is in place if they would be subjected to tier one
screens for endocrine activity?
MS. ANDERSEN: Okay. I think it would be useful if you
actually looked at the tiered process in the -- what is in
the first tier, and maybe we can provide that to you to understand
that. But there are a number of tests that are there. So you
are looking through several different essentially modes of
looking for toxicity, and if you end up with no toxic endpoints
at those levels -- typically these products are actually tested
at a higher level than are conventional chemical pesticides
to determine that. But you can, indeed, come and look at --
you know -- like Methyl Salicylate is the one I had up there.
You know that at high levels that's a very toxic compound.
Yet we also know that it's in chewing gum and all kinds of
things. So if we also have a concept that the level of it
is going to be extremely low -- for example, it's much lower
in these boxes than it is in gum, or your corn flakes would
taste like gum.
But it's at extremely low levels, so you consider that and
you can do a -- you know, again, we use a safety factor. Often
200 or greater. That if you know you're way below that before
you see any toxic effect, then you don't have to do all of
the higher tier testing, which again is, you know, just using
animals that don't need to be tested, etc. But the scientists
do look and do a risk assessment for every one of these products
and determine whether or not they have to go on to higher
levels of testing. But I'll be glad to provide you with that
list of studies. It's not actually -- all of them are not
on the tip of my tongue. But all of these products require
the standard six pack you do for every end use product and
a number of other testing -- immune testing and some -- typically
a repo study. Actually, probably Gary can tell you better
than I can. He's probably had to do more of them. But there
are often even a 90 day feeding study. I think that that's
required for a lot of these products.
FEMALE SPEAKER: Janet, are you going to speak
about endocrine disruptors?
MS. ANDERSEN: Oh, endocrine disruptors. Yes, some of
these products will be subject to endocrine disruptors, especially
if you're thinking about things like insect growth regulators,
etc. They will go through part of that. It is envisioned they
will. But many of them will not because of the large understanding
we have of those products already.
So some of them will and some of them won't. I do not believe
it's envisioned that any microorganism is going to go through
that testing. Partly I think they wouldn't know how to approach
it. But that's the concept. I have Alan Lockwood as the next
DR. LOCKWOOD: I have a question about the safety testing
of the microbial pesticides. How does one assure oneself that
agents are not going to be pathogenic in certain populations?
For example, an immune compromised host?
MS. ANDERSEN: It is considered -- I think the literature
is fairly well described of what that is. But it doesn't mean
you don't have issues that come up, and we handle them in
the same kinds of ways we do when issues come up with conventional
chemical pesticides. An issue has come up with the microorganisms
we have regulated called Burkelariasapacous, which when we
registered those products back in the early '90's, the agency
thought -- and so did the medical community -- that we knew
well the taxonomy of those products.
Even though this is an extremely common soil microorganism,
it's now known that there are -- there are strains -- well,
it was already known. There are strains that can infect people
who are immune compromised, especially with cystic fibrosis.
And the state of knowledge has changed enough that there are
now questions about all of that genomics assigned to it. Where
they belong and which gene of ours, etc. We have required
of that company tremendous data call in to try and resolve
some of those issues. And the company is just about to decide
what to do, whether or not to support that use or not, and
we should have that answer this week or next about it. Because
we have those questions and have to have them resolved. So
when questions arise, we look at it. But we certainly are
asking those questions and considering that when we look at
those products as we register them.
Alan James is next.
MR. JAMES: My comments --
MS. MULKEY: You need a mic -- I'm sorry -- because
MS. ANDERSEN: Oh, I'm sorry.
MR. JAMES: I thought I had it there for a second. My
comments have to do with the handout material. I wanted to
point out a couple of issues based on conversations we had
this morning. The one that is called, Your Explanation Sheet
on Biopesticides, and I call your attention to it, if you
have it convenient, on the second page. We were speaking this
morning of the agency's concern about overstatement or misleading
statements. On the second page, based on the conversations
we had this morning, there are a couple of areas I would like
to point out that maybe we could think further about and possibly
reword or at least consider it. The first bullet point under
what are the advantages of using biopesticides. Biopesticides
are usually inherently less harmful than conventional pesticides.
I think that statement is an indictment of the EPA's registration
process in general, and it just doesn't seem to fit very well
with what we're trying to accomplish.
The second one is the fourth bullet point. When used as a
component of integrated pest management, biopesticides can
greatly decrease the use of conventional pesticides while
crop yields remain high. I don't think there was too much
support for that statement from the experts around the table
this morning. They play a valuable role in integrated pest
management, but I think that statement might -- we ought to
look at that statement and see. If it's going to be on the
Internet site, maybe it needs some minor wording. The third
one, however, I would like to commend the agency for writing,
and I appreciate it, Janet, if you wrote it. It's on the right-hand
column, the second paragraph, where we point out that the
EPA always conducts rigorous reviews to ensure that pesticides
will have -- not have adverse effect on human health or the
environment. For EPA to be sure that a pesticide is safe,
the agency requires a lot of data. We do appreciate, finally,
the acknowledgement that the agency assures that pesticides
are safe. Thank you, Janet, for that.
MS. ANDERSEN: Okay. Lori?
MS.BERGER: I hope I can remember the question I'm trying
to address. But it had to do with Gary's comments about PCA
awareness in the field of biopesticides. And I'm really surprised,
at least for California, that number is 50 percent. I would
like to look at that information. And it might be a nomenclature
type situation, because we have so many people using Bt's
in California very effectively. I think that they might be
thinking of them more in terms of microbials versus biopesticides.
That's just kind of a newer term. The Bt's have been very
effectively used in California, especially the stone fruit.
This has been a super tool especially at bloom time, and we've
been able to significantly reduce the uses of organophosphates
in some cases up to 60 to 75 percent with the use of these
tools. And so that's been just extremely valuable and we wish
we had more of these types of materials. So I was just surprised
that over half of the people are reported as not knowing what
And I would like to underline what Win had to say, that education
is the key and where is that education going to come from.
Larry eluded to the fact that Cooperative Extension -- and
we've got some great Extension folks out in California. But
that system is just not being funded. They're not replacing
people. The folks are overloaded. And at the same time, we're
getting technologies that are requiring more time on the part
of these people.
So it's either going to come from the private sector, the
companies themselves, and that's looked upon not very credibly
in a lot of cases, but that's what a lot of folks are doing.
And then also there are some collaborative projects in California
-- the Pest Management Alliance programs. Whatever we do,
we need it in the field for people to see. For growers to
see. For pest control advisors to see. I think the web site
and those types of materials are very helpful when you're
talking to people at levels where they're interested in web
site based information. But, you know, seeing is believing,
and the most success we've had is seeing these things in the
field. And so we need to expand the demonstration type projects.
Again, this is where an expanded EUP -- for using things like
pheromones and Bt's, or even with plots that are four trees
big. It's just not going to work, and we really need to see
it in the field. So those are my comments.
MS. ANDERSEN: Can I just ask what the Pest Management
Alliance program is? I don't think you covered that for.
MS.BERGER: Okay. That is a program in California that
is sponsored by the Department of Pesticide Regulation. It's
a grant program. These grants are up to, I think, $100,000
per year and they can go up to four years. And these are collaborative
projects with people from the university level, farm advisors
-- that's what we call Extension agents in California -- pest
control advisors and growers. And it's kind of a start to
finish, let's look at the pest management systems and see
where we can adjust. Use more biologically based materials.
We might specifically want to cut down on, let's say, OPs.
It's just looking at IPM systems and trying to make them more
reduced risk. So those have been very helpful. Again, seeing
is believing. There have been a lot of grower meetings, and
there have been a number of commodities -- strawberries, prunes,
pears, peaches, grapes. Just a number of these. Those have
been very successful.
We're running into some budgetary programs in California,
and we might be seeing a slow down of that program. But it
has been a model and it's been very effective. And Larry Elworth
is doing a project for DPR this year, where he is basically
reviewing these programs and reporting back to how effective
they've been to adoption of IPM and reduced risk. You might
want to comment on that later, Larry.
MS. ANDERSEN: Well, Larry will like this, because he's
next. Thank you.
MR. ELWORTH: How much time do I have?
MS. ANDERSEN: You're not constrained so far.
MR. ELWORTH: Right. Right.
MALE SPEAKER: I'm sure you'll fill it.
MR. ELWORTH: I'm sure I can fill it, right. A couple
of things. One is, if performance is a key issue in the acceptance
and obviously the use of these materials, has BPPD required
efficacy data as one way to at least help move the issue of
performance along? And recognizing this would be an additional
burden, is there a linkage that could be made to IR-4 or other
funds? That's one question.
The second question is, if in fact there is a backlog -- and
kind of a recent backlog, maybe one you haven't deal with
before -- and if you also know there are certain situations
in which biopesticides are more likely to be used -- let's
say there is a new pest, a pest that people are having trouble
controlling and there is a lost of existing materials -- has
BPPD looked at a priority setting process which would look
at where the most important opportunities were from EPA's
point of view, with the hope that the opportunities that EPA
targeted would also be the opportunities where growers or
grower groups would be most likely to adopt these? You know,
I know priority setting is done in other parts of the agency.
That would both deal with the backlog and also might make
it more likely that the more widely used materials got registered
relatively quickly. So those are -- that's two questions.
MS. ANDERSEN: Okay. So we'll do the questions and then
maybe then you'll answer Lori's point, if you wanted to, or
talk to more about what you're finding in that system. If
you want to.
MR. ELWORTH: Okay.
MS. ANDERSEN: Let me say we do not require efficacy
data for biopesticides outright. We have -- like all groups
in all the different registering divisions within OPP -- the
ability that if we do not believe a product is going to work
that we will ask for that data. And we have at times asked
for it up front where we really -- you know, we thought we
were looking at snake oil and we wanted them to show us that
And I know that there are a couple of products which never
did come to market because we asked those questions before
we really went forward. So there have been -- there has been
some of that. But on a routine basis, we do not ask for it.
And let me just say that the argument is often why should
they be put to a burden that we don't require for the other
MR. ELWORTH: Sure.
MS. ANDERSEN: And I think there is some merit to that
MR. ELWORTH: Uh-huh.
MS. ANDERSEN: I think though we will find that as we
partner with Canada, Canada requires efficacy data, so we
see some of it in that case. But also California always requires
it, and I think there may be some move in California to change
that. But given that this is such an important market for
biopesticides -- the California market -- that we often can
look and make adjustments that way. And California is -- they
have no compunction of calling us up and telling us that we
ought to be able to do something here or there or whatever.
So that's quite an open relationship between the two organizations.
But we have not required efficacy data, and for that reason
I think more than anything else. We don't think it's fair
to put an extra burden on them.
MR. ELWORTH: Is it something that then you and your
trade organization certification issue might consider in submitting
efficacy data to the agency as part of a certification program?
MS. ANDERSEN: Well --
MR. ELWORTH: Not by whereby you would certify it. But
where you would have reviewed the efficacy data.
MS. ANDERSEN: Well, let me say first something about
the certification. Maybe that hasn't been required. In order
to be certified under the program they've been discussing,
it has to have been registered with EPA for two years before
it can even be considered for certification. So in that sense,
it wouldn't work.
But I think it's again like all of the other kinds of ideas
that you've brought up as potential solutions. Here is one
to look at and one for us to think about with our partners
with IR-4. Is there something more that we could do there.
And certainly hearing repeatedly the importance of demonstrations
for really having growers see how well these products work,
you know, the demonstrations maybe speak louder than a number
of piles of studies that show whether or not things work.
I can't imagine why a grower is going to very often use a
product that doesn't work, so that makes sense. BPPD does
indeed have a backlog and it has come -- we had a very difficult
year last year within this small division, and it had to do
more with those plant incorporated protectants than it did
with most of the things that we're talking about. But we had
-- we convinced our office director that we really needed
some more contract money, and she was terrific. She gave us
a lot more money than -- frankly I can tell her now -- that
I ever expected we got.
And it takes a while to do it. We've had it a little over
a year and it's starting to make a difference, I think, in
what we're seeing how much time it takes. So we're having
contractors now essentially do all of our primary reviews
and where we did virtually all of it in-house up to now. And
this will make a difference in our backlog. You actually ran
into a problem that we had this year, where we ended up with
a problem. We really wanted to meet a deadline that you had,
and you were working with a group of growers to be able to
put a product in the market. And I think -- I can't actually
speak to the Registration Division, since it's one of the
organizations where they -- that I actually never worked in.
But in our organization we are small, and we are -- I know.
Kathleen and I both personally worked very hard to try and
resolve that issue and trying to get people in parts of other
organizations to help do the reviews, etc., to make that product
So where we know we've got a critical demand like that and
we're really trying to put a demonstration in place, and where
it really does, we think, make a difference, especially if
we're replacing organophosphates and other kinds of products
like that, we really do try to go that extra mile to push
it along. As far as a priority setting, what we are trying
to do is much more on a risk basis. Because we recognize that
all of these companies -- almost all of these companies we
deal with are very small, we try to not put -- (End of Tape
2, Side A.)
MS. ANDERSEN: -- realize that there is a potential
-- a product there in the market -- or in our queue that we
could really use to try and replace, or to meet an immediate
demand, we will work to bring that up in the queue and try
to make that happen. We do have a lot of active ingredients
before us, and we have some issues in trying to balance it.
But we really do try to look at those issues as we go through
MR. ELWORTH: Well, just to answer briefly Lori's question.
The thing that distinguishes the Pest Management Alliance
projects from lots of other projects is they're very much
driven by the commodity groups. And I don't know how many
times I've talked to people who have either had conventional
materials or reduced risk materials or biopesticides. I'll
talk to them, and they'll say, well, what should we do, and
I'll say have you talked to the commodity group and the growers.
And the answer is usually no. And where the projects have
been successful for the Pest Management Alliance is where
they have relied very heavily on the grower groups to be involved
from the beginning. So I would -- that's one lesson from PMA
that I think is applicable to this situation.
MS. ANDERSEN: Thank you. Let's go on to Phil.
MR. BENEDICT: I would like to go back to the education
issue for a minute. USDA NRCS -- our Natural Resources Conservation
Service -- is charged with helping farmers put conservation
on the farm. EQIP came up earlier. And with a big influx of
money into EQIP, there is going to be a lot more opportunity
to do that. And this is really I think a message to the industry.
I really believe that that's another field force with 3,000
offices out there. There is basically pretty near an office
in every county, where there is somebody charged to help a
farmer write a conservation plan to solve that farm's resource
problems. And pesticides are considered a resource problem.
There is a huge field force in Natural Resources Conservation
Service that is untapped today from an educational point of
view. So I honestly believe there is another field force,
but I think your organization would have to begin to work
with the leadership there. They work on waste management systems
a lot. They do a lot of work with integrated crop management.
A lot of that has been our management issues. But pesticides
are certainly part of that. So there is this other huge field
force that nobody is using today. And they would need a lot
of education and a lot of information, but there is a delivery
system to help farmers write management plans to deal with
resource issues and that's what you're going to need to do
if you're going to get EQIP funds. With that said, I guess
I can begin to work with them.
MS. ANDERSEN: I thought EQIP was an interesting idea,
and we might -- if we seem to have a little more time, Al,
if you could -- might describe -- I had several people ask
me what EQIP was and how it works. Can you provide us a little
bit more background on it?
MR. JENNINGS: Very little bit. You want that now?
MS. ANDERSEN: Yeah.
MR. JENNINGS: Okay. Environmental Quality Improvement
Program. As I said earlier, it's been in the farm bill and
funded to, I think, half a billion. I probably said a billion,
which is too much. But the money has largely gone to animal
agriculture. It is a direct funding of farmer built or farmer
deployed pollution prevention. In the case of the animal agriculture,
a lot has been with manure management. Essentially keeping
the manure out of the water. There are various ways to express
that. But anyhow, under the new farm bill with the vast increase
in money, we are looking at it as, yes, it is going to remain
important for animal agriculture, and those people do have
a major claim on the money. But we're hopeful we can move
it into other resource management.
Comments are very well taken. There is a large work force
out there, and I have just begun discussions with NRCS about
how to help them spend all this money they're going to get.
They, of course, are always appreciate of help on how to spend
money. But anyhow, we will be working on trying to set up
a system. Right now one of my priorities is trying to integrate
our land grant system into that process. As Phil pointed out,
there are a lot of people out there in NRCS. One of the problems
is, they're kind of the old soil conservation types and now
they're the, you know, how to build a manure pit type. And
we need some additional training and expertise, and I look
at the land grant system as being well positioned to provide
that. Exactly how those details will shake out, I don't know
at this point. The only thing I can is we're working on it.
It's a good thing to report back on next time.
Was that enough, Janet?
MS. ANDERSEN: Yeah. Well, that helps me. I think we'll
be talking to you about that.
MR. JENNINGS: You would like to help spend their money,
MS. ANDERSEN: Yeah, sure. Why not. Steve?
MR. BALLING: I wanted to make one other comment about
education. Another hat I wear is the Chair of the National
Foundation for IPM Education, and we have been talking with
Janet at EPA and the Biopesticide Industry Alliance and IR-4
about doing some regional workshops. So I think that has an
opportunity to begin to find ways to break through some of
these barriers, particularly with consultants and Extension
to begin to talk through how do we break those barriers down.
I would mention, though, that of all that we've discussed
thus far as a potential user of biopesticides, there are three
things that I would say that I need more of. One is -- and
I mentioned this one already -- replicated data. Lori said
efficacy, efficacy, efficacy. When it comes to selling your
product, it's data, data, data. We have to be able to see
that this stuff actually really works in a replicated situation.
That's real valuable.
The second thing is, don't over hype the product. Dan mentioned
that in one of his -- in his comment earlier. That is so often
-- in the desperate attempt to sell some product to try to
fund your next set of data or your next product, these products
are oversold and they fail. And guess what. They get a bad
rep. And to be honest, if you look at Bt's, we talk about
Bt's as a success story. It was the failure story for 20 years.
So it's only recently that Bt's have overcome the failure
of their original disaster back in the '70's. And then the
third thing is, sell the product on flexibility and safety.
And I mentioned this. Reentry intervals and preharvest intervals
typically on these products are very short or nonexistent
and that provides to us as users a real benefit. And that's,
I think, one of the great ways to sell the product. So those
are the three things I think are important.
MS. MULKEY: I would like to pose a couple questions
to see if anybody can help with them. One is that in talking
with industry -- Julie and Beth will be interested to hear
that they put a lot of energy into talking about how they
need us to move faster and regulate -- register their products
But one of the reasons we hear from them that we don't often
hear from you guys is that their source of venture capital
is dramatically intertwined with the receipt of the registration.
And one of the things that struck me, is if I were a venture
capitalist and understood this industry, I'm not sure that
I would tie it to receipt of the registration. I think I might
tie it to some measure of sales. A successful EUP might thrill
me even more than a registration, etc. So if anybody around
the table has any insight into the money market around this
kind of thing and any intersection between those. Now, I know
we don't have any venture capitalists on our PPDC committee.
We'll work on that next time. So I wanted to pose that question.
And the other thing I wanted to do was ask Bill Tracy if he
has any insight from cotton culture land on this question,
if he feels like putting up his card, he should feel free
to. I don't want to put him on the spot. But I think it's
been especially useful to hear from people who are engaged
in production of agriculture.
MR. TRACY: As Lori had pointed out, in the cotton industry
we've used Bt's for years and it has worked out exceptionally
well, especially in the deep south. It's just starting to
come into California. But what crossed my mind when the discussion
was about how should we advertise or how should we get the
word out to the ultimate consumer, which is the in-field agriculture,
if this stuff works, it sells itself. There is nothing that
spreads faster than coffee shop talk about a product that
works. You don't have to advertise it. You have to show in
the field that it works through replicated trials and all.
As indicated in our state out west, we have an excellent Extension
Service. I use it. I got very interested when Dr. Benedict
mentioned the RCDs. I forgot the resource conservation districts.
That's one of the real untold success stories of USDA -- the
RCDs -- and they have not been used, unfortunately, since
1986. They've been converted into writing farm plans -- conservation
plans. They used to be the old Soils Conservation Service
that really taught us how to stewart our soils and all, and
a lot of those people were discouraged from the Service when
they turned them into secretaries to write farm plans for
folks. But this might give them new energy, too.
But to get back to your original question, nothing sells like
success in a capitalistic society.
MS. ANDERSEN: Marcia, you all right to go on?
MS. MULKEY: I'm finished with my questions.
MS. ANDERSEN: Thank you. Lori?
MS.BERGER: Yes. I wanted to comment on the -- what
had been said about the resource conservation districts. I
think that they are more widely understood and used in the
midwest. But it is a network out there, and kind of amongst
the minor crops people, we've been having some questions and
discussion about the possibility of using EQIP funds to assist
And, of course, people are saying, well, it's an old system
and it's water and soil and they just aren't going to want
to do it. But all of us are going to have to make changes,
and I think it might be a shot in the arm, like Bill said.
It is resource oriented. I can think of a lot of issues in
California -- and I'm sure elsewhere -- air, water. These
are resources, and the components that are important to a
successful IPM program are resources. And this is a network
that is already in place. One thing I do have a concern about,
and with all due respect to the land grant systems, which
I'm a three time product, it really concerns me that there
might be this huge pot of money out there and the land grant
might take up to 50 percent of that in overhead when we need
it in the field. And I think that there would be a benefit
to having a land grant to be -- we need them, and we've got
some excellent out in the field. But if we can keep that money
within the USDA framework, I think it will get to the people
that we are really trying to encourage to make changes. So
those are some comments on the RCD and use of NRCS.
MS. ANDERSEN: Thank you. Carolyn is next.
MS. BRICKEY: I had just a couple of quick comments
about the organic sector just to kind of close the loop on
that, and then I wanted to comment on what Lori just said
I have lots of ideas for Gary Libman and his group that I
won't go into in this group about things they could do. But
one of the obvious things that I want to make sure you're
aware of also, Janet, is that after October 21st when the
rule goes into effect, there will be a list of people who
are certified agents of the federal government who will be
certifying organic production. That will be a finite group
of people with names and addresses that can be contacted about
these issues. The other thing about Lori's earlier comment
about how farmers want to see how something works in the field,
I think is also true in organic. And I would encourage contacts
with some of the large growers in the sector that the company
may be trying to contact, and get them to grow a plot of whatever
it is with that material and get some feedback from the field
about how it works. Also, I want to encourage you to continue
your work, Janet, with the Board in terms of matching up the
national list with the biopesticides that you have registered.
I think that's really important to do.
With regard to your comment about EQIP, I think it's important
if you want to be effective and get something done with regard
to the use of that money, that you be very strategic and very
quick, because that's going to start happening, I think, pretty
soon. And Al is certainly geared up to work on that process,
but I would encourage you to move sooner rather than later,
if that's what you want to do.
MS. ANDERSEN: Thanks, Carolyn. Beth, I think you're
MS. CARROLL: I just wanted to make a suggestion. I
heard a couple of times this morning that the growers want
to be able to sleep at night. And one thing that we tried
at Norvatis -- and we're still back at the drawing board,
because we had some problems with it -- was a solutions package
that was an integrated pest management package for citrus.
We introduced it in Florida. And you basically would pay for
one of a couple of different levels of protection from diseases
and insects, and there was weed control in one of the levels.
So if it was a bad pest pressure year, you know, we bought
the farm and had to put out the extra application. If it was
a light year, pesticide did not go out, because the farmer
had already paid that amount and it didn't need to. We trained
scouts. We put them on real time scouting systems that the
growers could look at and see what the pest pressures were.
And I would just suggest this was labor intensive. But if
you have a biopesticide that you can integrate into a program,
and you would be willing to take on the coming in and doing
the clean up if it was necessary, then that might go a long
way toward getting the growers to take a look at it ahead
MS. ANDERSEN: Thank you. Wow. Marcia?
MS. MULKEY: How about that for timing. Well, I learned
a lot from this dialogue. I wanted to just take a minute to
talk about the resource issue. We have actually deployed quite
modest resources toward biopesticides, and we actually combined
that work with biotechnology.
And so the infusion of some -- in spite of Janet's gracious
remark -- actually quite modest resources in contract dollars
was -- although we are spending it on biopesticides, it was
primarily to accommodate the increased demands on our total
resources from biotechnology. And that's really the area where
we've experienced a draw down from our original programming
of resources. That is also an area where I would -- I think
people need to begin to think about all of these products
in an integrated way. And the last thing I wanted to say is
for reduced risk pesticides -- conventional pesticides --
for certain kinds of biotechnology and for many biopesticides,
the complexity of the pest management system is increasing.
And many of the points you all are making are not limited
to biopesticides. Some of the special limitations involving
the sort of industry resources and some of that may be specific
to this. And so I think we are learning that collectively
if we want to have an impact through our registration program,
we have to pay attention to adoption questions and not stop
our horizon at the issuance of a registration.
But it's not an obvious role for us. It's not easy for us
to figure out how to be constructive players, and it can undermine
our credibility if we're not careful in terms of our attempting
to play a particularly comprehensive role. So we will continue
to seek input about the adoption question and about things
like resistance management, which as you know, we've treated
as extremely important for the bio-engineered Bt producing
because of the very things that we've heard around this table.
The importance of the Bt products. Not the plants, but the
actual products. So we will continue to try to solicit input
from you that help us understand our role. But we are interested
in making our -- we are making choices about resources. Making
it in a way that is results oriented and not just symbolic.
And toward that end, I think this has been extremely helpful
to us and we value it.
But Ray has his card up, and we still have a little time.
So I'll turn it back to you, Janet.
MS. ANDERSEN: I'm sorry I missed that one, or maybe
it popped up at the end.
RAY: I just put it up.
MS. ANDERSEN: Okay.
RAY: I just have one quick statement. I think it would
be interesting for the agency to compare -- or to gauge its
success by the commercial adoption of the products it registers
across the board.
MS. MULKEY: Right. And Joe Merenda will talk about
this a little bit in the update in a minute. But we are beginning
to track a measure of adoption for reduced risk pesticides,
which includes most of the biopesticides, but also the reduced
risk conventional, as percent acre treatment as an effort
to try to get a handle on that.
So we're in agreement. We need to measure real world results
and not in addition to our activity levels. Obviously, activity
levels are important to making sure we're, you know, doing
something with our money.
MS. ANDERSEN: So -- oops. A couple more up here.
MR. BENEDICT: I would be concerned about that. There
are lots of ways -- you know, we've talked pretty much about
agriculture today. There are success stories with microbiologicals.
There is Bt-I, which is used in mosquito control districts
across the country. It's all we use. And there is lots of
nitch markets. I think there is a lot of specialty markets
out there where these products, I think, can play a much bigger
role than they can in the commodity areas. The commodity areas
pay the bills, unfortunately.
So I think you need to be careful how you define what Ray
is talking about. I think Bt-I is a huge success story. I
think it's -- it has changed mosquito control dramatically.
And I think it's been very successful, and we really never
mentioned that today.
MS. ANDERSEN: It was on my list of one of those things,
and it is important. And we have several strains, and we have
some interesting new varieties coming along.
MR. BENEDICT: Well, it's a new strain to deal with
Killex mosquitoes basically.
MS. ANDERSEN: Right. Yeah.
MR. BENEDICT: Which is the West Nile Virus issue, which
is going to be -- you know, from a turbid water point of view,
it's going to be extremely important. It may not have a lot
of use, but where it's going to get used, it's going to be
extremely important from a public health point of view.
MS. MULKEY: I didn't mean to leave the impression that's
the only measure we're interested in.
MR. BENEDICT: Well, I want to make sure it's not, because
I think a nitch market is going to be very important.
MS. ANDERSEN: Thanks. Lori, you haven't spoken yet,
so we're glad to hear from you.
MS. HARDER: I just kind of had a question. The federal
government has a lot of different agencies and a lot of different
land holdings, and they do use pesticides and other controls
on their land and in their buildings for various reasons and
activities. And I'm curious to find out how the biopesticides
play out in your agencies with, say, the National Forest on
using herbicides, and if that is considered a reduced risk
pesticide. And is there some kind of policy that can come
out of that, so that the federal government maybe has a little
bit more leeway in doing research projects and testing these
products on land where they're not necessarily getting any
kind of revenue from it.
MS. ANDERSEN: Well, let me talk about two agencies.
You mentioned the U.S. Forest Service. I'll start there. And
then the Department of Defense that we have worked with quite
a bit. The Forest Service has a pest health management group.
And one of that is a group in West Virginia, and they are
responsible for trying to find pest management controls. And
they really have a philosophy that they want to use biological
pesticides wherever possible. We work closely with them. They
have -- they worked with IR-4 to help us. They actually have
a regulatory person on staff. And, you know, I know these
people extremely well. We're back and forth with them. So
we have done some products specifically for them. But they're
really the holders of Jibcheck, which is the insect virus
control that is used quite a bit, and also for Bt. And it's
interesting. They and others -- state and local agencies --
who use Bt have often a very difficult time explaining to
the public why they are spraying anything out of a helicopter,
whether it's Bt or, you know -- which I frankly consider a
lot safer than Demilune -- or some of the other kinds of products
that they use. But they're very committed to that in all kinds
of areas. And a number of these agencies are looking especially
at invasive species especially. So they're looking also to
find ways to help use safer products to control their pests
on landscape like that.
Now, I've not worked with BLM at all, but I know the National
Park Service has a strong IPM program. The Department of Defense
has done a terrific job of trying to reduce their reliance
on chemical pesticides. And when we started what is now PESP
for us, but what was originally called the Reduced Risk/Use
-- or whatever way it was -- Initiative. The Department of
Defense stood up and said we'll commit that we'll have 50
percent reduction of our chemical pesticides by the year 2000,
and they made that 18 months earlier. They have just done
a fabulous job. And we have some really interesting work we
haven't talked about here. But really important pests are
fire ants, if you live in the south, and they've got a fascinating
program that we have helped work with. And we often work in
cooperation with some USDA scientists and FDA -- I'm sorry.
USDA, DoD and EPA trying to find some innovative ones, which
if it can work on those kinds of sites, then you can, you
know, take them out. So that's a real good point and an important
point for us to work with our other federal partners.
MS. MULKEY: Janet, Alan is offering to --
MS. ANDERSEN: Okay.
ALAN: Yeah, just kind of a broader perspective is that
all federal agencies and departments have this thing called
the National Environmental Policy Act that we must comply
with, which requires on any program that you look at the environmental
consequences and the options. And there is great pressure
in any pest management program that we do or any other federal
agency does to select the least damaging control options.
So that really is driving, as Janet described the Forest Service,
which is one of the USDA agencies, towards adopting safer
products and biologicals when they exist and work. So the
pressures are there to make it happen.
MS. HARDER: I experienced, though, that the need for
process doesn't necessarily apply to pesticides because of
the registration process that pesticides go through. So therefore,
they don't have to do an assessment of the pesticide on the
environment through NEPA, which is in court right now in litigation.
ALAN: Yeah, it's probably -- it probably does vary
from agency or department. But certainly in USDA, all of our
programs -- you know, there is a heavy emphasis on selection
of the chemical or chemicals of choice and evaluation of those.
MS. MULKEY: Okay, Janet, we need to wrap up.
MS. ANDERSEN: Yeah.
MS. MULKEY: So we can move on to the remaining topics.
MS. ANDERSEN: I was going to say Bill and then Bob
and we'll go from there.
MR. TRACY: I have an additional comment from the cotton
industry, and I really don't know where this program fits,
except for the fact you don't use pesticides. In California
we've had a successful program for 35 years keeping the pink
bollworm, which is an extremely devastating pest if it ever
invaded the industry. In fact, it took cotton out of the southern
valleys of the state for a long time. But in the 35 years
that this program has been in place -- and it's been totally
grower funded by a per bale assessment -- my calculations
are we've kept about 150 million pounds of pesticides from
being used by this program. And what we do is a triad of issues.
First of all, we -- you can imagine selling this to farmers
back in the late '60's. We propose to drop five million sterilized
pink bollworm over the valley on a daily basis. Every day
of five working days. So cast your mind back to 1968 and saying,
hey, we're going to take this pest and we're going to drop
it over. But what happens if you sterilize the male bollworm,
the female only mates once, so you're saturating the area
there of any potential female of mating with a sterile. Secondly,
we have an extremely aggressive pheromone trap system to check
and see if indeed there are critters in there. If there are
critters and we have a hot spot, we use a pheromone based
insecticide to go in and trap just the pinky and not any of
the other critters -- the good critters that are out there.
And the third leg of this triad is that we have a mandatory
plow down day. You can't plant your crop before a certain
date. You have to have the crop plowed down by a later date.
And that disrupts the life cycle of this critter. If some
of them happen to come up during that host free period, it's
a suicide emergence.
This has worked extremely well for 35 years. It doesn't work
on every critter. It works on this one and it has been very
successful and totally grower funded. So I'm not sure if it
fits into this debate --
MS. ANDERSEN: Sure it does.
MR. TRACY: -- where the mix is. But it is an intriguing
MS. MULKEY: What you've added is this idea of working
together and having a funding mechanism and so forth, so you
can go beyond the individual farm for some projects.
MS. ANDERSEN: And last but not least, Bob, do you want
to finish it up quick and we'll move on.
MR. HOLM: Yeah. I just wanted to mention that IR-4
puts together what we call a new products transition solutions
list, and I'm going to circulate this around. And if you're
interested I have a copy of the roster, so if you check it,
I'll be glad to mail it to you.
But I thought I would comment on our list. These are all new
chemistries. We're tracking 300 total new chemistries and
72 of them are biopesticides. So that's a fairly high percentage,
about 25 percent. But it's interesting that the percentage
by classification ranges from only about 7.6 percent for herbicides
up to 39 percent for nematacides and then insecticides and
fungicides are about 30 percent. So I heard people mention
about bio-herbicides. There is not a lot of talk about them,
because basically there aren't very many products on the market,
and those that are on the market are very narrow spectrum.
But there are certainly a lot of bio-fungicides and biological
insecticides out there, but the herbicide area seems to be
so far to really escape very broad use or broad interest from
the companies as far as developing new products. But I'll
circulate this around and certainly if you're interested,
I'll be glad to mail you a copy.
MS. ANDERSEN: Thank you all very much. I really have
appreciated. I started off by thanking for the interest in
the group, and I really do appreciate all the comments and
diversity of opinions and ideas that we got. We will put this
together as a report and be back to you all for you to see
it, and hopefully we'll have ability to even do it through
the chat room a bit and get some dialogue back before we actually
come back to this dialogue committee. Thank you.
MS. MULKEY: All right. Now, we're going to shift gears.
When we floated the idea of spending some time on e-issues,
some of you said, ho hum. We're hoping that before we're finished
with at least these two, you won't think they're ho hum. But
actually, I think all of us of a certain age have a little
more trouble getting this, at least than my kids seem to,
about just how much this next set of topics really is critical
to our future. Lin Moos, who is now acting Director of our
Information Resources and Services Division, is going to chair
this segment. Some of you may remember Lin as one of our people
in BEAD in the '80's that was involved with some key -- people,
you know, who get started in pesticides always come home.
It's just too interesting not to.
But Lin is going to chair this segment. I want to mention
that the two topics we've keyed -- I want to just mention
two facts about each of these topics. With respect to e-commerce,
I think that there is increasingly an e-market in pesticides
whether we like it or not. We're seeing the beginnings of
some problems in that market. And probably nothing yet of
the potential of a really broad scale version of that market,
but it's time to start thinking about it.
With respect to electronic data submission, I will tell you
that those who have some -- more experience of it than we
do, like Canada, are really convinced that this has the potential
to save EPA processing time in the registration arena by 25
percent or more. So those of you who are worried about our
registration resources, and about our productivity and our
production, this is a topic you ought to sit up and listen
to, because there is some evidence that this can make a huge
difference. So without more introduction, I'll turn it over
MS. MOOS: Okay. As Marcia said, our topic for discussion
for the next hour and 15 minutes is the electronic media issues.
Margie had sent out a package to you folks last week, and
that package included 401 pages on electronic issues. It included
the e-commerce paper, the electronic submission paper, and
it also included an e-FOIA paper and an e-dockets paper.
We're going to talk about the electronic submissions and the
e-commerce today. But if anyone has any questions about the
e-FOIA or the e-docket, I'll be around the rest of the day.
And Sherri Street, who runs those programs, is also here,
so feel free to ask any questions on those topics as well.
So let's move forward for today's discussion. We've got about
35 minutes. I still believe we have about 35 minutes for each
topic. And what I would like to do is limit our presenters
to a maximum of 15 to 20 minutes, so we've got at least 15
minutes for questions and dialogue with you folks from the
advisory committee. Our first panel will discuss e-commerce.
The panel participants include Karen Angulo from OPP. Karen
chairs the OPP e-commerce committee and she is a Special Assistant
in SRRD. Tim Creger is going to be joining us by telephone.
That's the noise you heard over there a moment ago. Tim is
the head of the AAPCO Information Technology Committee, and
he's in the Nebraska Department of Agriculture as the Program
Manager for Pesticides, including both field programs and
We also have both Jack Neylan and Paul Meehan here. They're
from our Office of Enforcement and Compliance Assistance.
Jack works from the compliance end and Paul is in the enforcement
And so I'm asking that each of our presenters here limit their
presentation to about four minutes, so that we've got plenty
of time for dialogue. And Karen -- Karen is going to start
MS. ANGULO: First I would like to make sure that Tim
can hear us. Tim, this is Karen. Can you hear us?
MR. CREGER: Yes, I can.
MS. ANGULO: Great, okay. I'm going to start. What we
would like to do is give you an update on the agency's effort
to date in the area of pesticides in e-commerce. As you probably
know, pesticides are being sold over the Internet both legally
and illegally by a variety of companies and private individuals.
In EPA and our state partners, we've been investigating whether
this is a cause for concern and the extent and the nature
of this type of commerce.
What I would like to do is give you a quick snapshot of how
EPA views pesticides in e-commerce, our efforts to date in
assessing the state of e-commerce, and very quickly the current
activities and a picture of the future.
I've actually heard someone say that the old rules don't apply,
that this is a totally new way of selling pesticides, and
so FIFRA just doesn't even apply to any of this any more.
And that actually is not true. This really is just a different
way -- a different vehicle -- for selling pesticides and buying
pesticides, very similar to, you know, catalog sales, phone
sales and magazine sales and FIFRA really does continue to
apply. So as I was saying, all of what we were doing before,
all of the programs and all of the information, all of our
outreach efforts, need to be tailored to this new way of selling
pesticides. But we really believe that we have a current,
good set of tools and that the laws are appropriate.
We have the Office of Pesticide Programs involved, as well
as the Office of Enforcement and Compliance Assurance, and
the Association of American Pesticide Control Officials --
AAPCO. They have an IT committee that is getting very active
in this. And I'm going to be passing this off very shortly
to Tim, who is with the AAPCO IT committee, and Jack and Paul
in OWECA, and they will be giving you an update on their activities.
Very briefly, though, we have started off by trying to establish
a base line. I mean, what really is the problem. And the very
innovative solution of establishing that base line was surf
day, where we went out and looked for web sites and tried
to get an idea of what the problem was. And Jack is going
to be given you an overview of that. But my favorite, the
one that I found, was a product that claimed to kill computer
viruses. It was a little pump bottle, and it instructed you
to open the disk drive drawer and spray this liquid in the
disk drive. And it would kill computer viruses and harmonize
the electronic forces in your computer, and I bet you it would
work. I bet you it would. It was a very interesting exercise,
and Jack is going to give you an update on it.
EPA and the states are developing compliance and enforcement
strategies. And Paul is going to give you an overview of that.
And AAPCO has been very innovative in their exploring ways
to identify web sites that may be selling pesticides illegally
and thinking about ways to contact them and monitor their
compliance. And lastly, we're thinking once we understand
the nature of the problem, of developing a web site that would
provide very helpful information, very similar to our ombudsman
service now, and tapping the information that is currently
up on our web site. This would help people who are in the
business of selling pesticides, and those people who don't
know that they are actually in the business of selling pesticides.
There are a lot of folks, we believe, who have no clue that
they're actually selling a pesticide product. So this web
site would be a very good way for us to share lots of good
information about how to register and sell and purchase a
pesticide. So with that, what I would like to do is hand it
over to Tim, and he's going to give a brief overview of the
AAPCO IT committee's activities. Tim?
MR. CREGER: Thank you, Karen. The AAPCO IT committee
was conceived and started in August of 2000. I've been the
Chair since it got started. The initial focus of our committee
work was on e-commerce issues. One of the largest projects
that we worked on in cooperation with EPA was development
of what we call the notification document, which is available
for review by anyone that wants to access the AAPCO home page.
They would select the e-commerce hyper link button and it
would immediately take them to the document, showing them
the full document as it was finished off and published on
that page. The next step that we had identified is how we
get that information -- that notification document -- out
to the public. Out to the web sites and purveyors on the Internet.
There are a lot of different ways we can do that. I believe
that EPA as an agency is moving forward with ways to do that.
What AAPCO chose to do is to post this particular document
on an electronic bulletin board called the Pesticide Regulators
Forum. That's actually part of the AAPCO web site hosted by
Perdue University. But it's a secured site for pesticide enforcement
and regulatory officials only. That document will be archived
And we're in the final stages of programming the site so that
any state lead agency or federal enforcement official can
enter the site using our password protected access. They would
then be able to enter the Internet address -- the URL address
-- for the web site in question. And the site will be programmed
so that it will pull up that address. It will tell the regulator
whether that particular Internet access address has been a
recipient of the notification document yet, and if not, it
will automatically send that document to that site with a
cover letter that explains why they're receiving it and what
to do in response to receiving it. And then it will archive
any responses that that web site has back to that AAPCO Perdue
site, the Pesticide Regulators Forum. And it will archive
those responses. It will also archive every time a state sends
that notification document out, so that it will reduce the
amount of redundancy that the states have sending those notification
documents out to the same site constantly. It will also track
the responses and allow the states to decide if there has
been an adequate change in compliance by that company. And
if not, then additional action can be considered.
That actually is supposed to be done by mid-summer or so.
Vicki Kaysons with the Perdue site there is going to finish
that up, and I've been in contact with her. If there are questions
of me, I can answer them at the end. If not, Jack Neylan also
is aware of that operation and can help answer those. Karen,
that's about it in a nutshell.
MS. ANGULO: Okay, Jim. Thank you. Hang on the line,
because we're going to have some discussion and there may
be some questions for you.
MR. CREGER: Will do.
MS. ANGULO: Okay. Jack is up.
MR. NEYLAN: Okay. As others have said, you know, my
office tends to be the place where a lot of the complaints
end up for us to deal with, and we started seeing more and
more complaints about Internet web sites showing up. And because
of the nature of the Internet, I think -- we think of it as
a little bit different. The breath of where you get information
out is wholly different. I think we're used to dealing with
pesticides in a way on a more local basis. You might have
something being sold in a state and it doesn't get beyond
the state. Advertising doesn't get beyond the state. But the
Internet is a wholly different thing. We decided to pick up
a theme that we saw some of the other federal agencies doing,
and as Tim and others mentioned, we conveyed a surf day last
June. We had about 60 participants. They were EPA headquarters,
regional and state people. And we gave those participants
some direction. We gave them specific surf engines and surf
terms to look through. So we tried to direct it in a little
bit in that way. And we gave them some forms and so forth
to fill out to collect information if they identified a site
that they thought was problematic, and we set them loose for
a day to just basically go ahead and surf and collect information.
I guess we got back about 600 plus forms that were filled
out where the participants identified problematic web sites
in some form or another.
And Karen mentioned her favorite one. I had one that was 911
relief, and I find that a little sleazy coming from when it
did. But it basically was advertising supposedly an antimicrobial
product that would kill anthrax topically and on hard surfaces.
That's really the kind of things we ran into. In any event,
we found -- through this surf day we found lots of different
types of sites. I mean, we have your registrant, producer
web sites. You have pesticide distributor web sites that are
in the pesticide trade. You have general retail sites selling
pesticides. Commercial users and applicators have sites. There
are auction sites advertising pesticides, like E-bay and Yahoo,
the general commercial sites. Plus there are agriculturally
oriented ag auction sites now and there are foreign sites.
Recently, for example, I've noticed a number of people sending
me e-mails where they're getting direct solicitations from
China on pesticide products. I've got this product. Come buy
it. They are very short and sweet, but they -- you know, they're
somehow or other broadly doing this.
We found virtually every kind of compliance issue you could
imagine on there. We're finding unregistered pesticides. We're
finding restricted use pesticides being sold there. They're
unfettered. There is no information about the fact you need
to be a certified applicator to get this. You need to be licensed
and so forth. They're just out there selling them. There are
unbelievably different claims from your registrations found
on these web sites and minimum risk pesticides. So we found
lots of different things. Even this little bit of a surf day,
we also asked people to figure out how many hits we got. We
got like 82 million possible surfings if you went down those
things. So, I mean, it's a huge thing. And we excluded government
and education sites. We're developing a compliance strategy.
We're pretty close to doing that. We're going to work it up
the management chain so people get an idea of how we intend
to do this. Tim gave you one of the examples of things. I
might close with saying that we've been working pretty closely
with the Federal Trade Commission and FDA, because they have
similar issues and have been addressing it in similar ways.
MS. MOOS: Okay. Thank you, Jack. Paul?
MR. MEEHAN: Sure. As other people have discussed, the
Internet presents some new challenges from an enforcement
perspective, but really the basics of enforcement remain the
same. Within the enforcement office, e-commerce is becoming
an increasing priority. We expect -- EPA expects to play a
major role in e-commerce enforcement, in part because we believe
EPA is especially well positioned due to the interstate nature
of much of e-commerce. We also think states will play a large
role, as they always have in pesticide enforcement, and we've
basically been trying to make connections with them whenever
possible. And Tim Creger obviously plays a large role in that,
and we think ultimately that any successful program will have
to have close coordination between the states and EPA. As
other regulatory agencies who looked into e-commerce found,
the Internet does open up a new arena for people who are unscrupulous.
The most important issue this presents from a pesticide enforcement
perspective is the potential threats to public health that
marketing of pesticides that are ineffective or in fact toxic
present. But it also presents issues of a level playing field,
because people who don't follow the rules and sell their products
over the Internet are basically getting a leg up on the majority
of the vendors who are following the rules. As Jack described,
there are many types of sites just as there are many types
of products and vendors. In a lot of instances, I think that
what is needed is education, but in other instances what is
needed is enforcement. So far most of our efforts have focused
on building an enforcement program infrastructure. As Jack's
office is doing, we're working up a guidance to provide guidelines
for our regional offices for the National Enforcement Program.
We've also been working to digest the information from an
enforcement perspective that was collected during surf day.
To date we have issued three stop sell orders, two of those
being against companies that were selling anthrax -- unregistered
anthrax products over the Internet. And that was in part an
action with our relationship with the FTC. These sites were
referred to us by FTC. Their authority -- they thought that
our authority to issue a stop sell was a quicker remedy to
the problem than the authority that they have under their
We also have issued a stop sell against a marketer of a product
that was advertising itself as effective against hoof and
mouth disease when it was not registered for use against hoof
and mouth. So at this point, we're, as I said, trying to build
our enforcement program and working with the other offices
at EPA to get a handle on what our priorities should be and
where we should move from here.
MS. MOOS: Thank you. I would like to open it up for
questions or comments or other experiences that folks may
have had. I'm having trouble reading names that far away.
That's Win, right?
MR. HOCK: Okay, a number of questions. You mentioned
about the sales from overseas such as China. How do you regulate
something like that? I can understand where you can issue
a stop sell for an agency or a company in the United States.
But when you start getting them from all around the world,
you know, I'm curious how you handle that.
And the other question, or I just want to make a comment,
I guess, is you mentioned about some of the problems. We in
Extension and the state lead agencies are very concerned about
RUP sales via the Internet. Obviously, if RUPs are getting
out there, how do you regulate them? How do you get those
people certified? I mean, there are all kinds of room for
hanky panky, if you will. The other issue is -- and I don't
think anybody brought it up. I'm real concerned, and I know
a lot of my colleagues are concerned, about the security issue.
If you can bring all kinds of wonder cut products in, what
-- I mean, you talked about some toxic materials. Toxic, yes,
to the individual who receives and who uses them. What happens
in terms of the security issue. The terrorism issue. We're
concerned about that very much at the state level.
MR. MEEHAN: Well, I can say -- I guess I'll take them
in order. The international issue is something I was hoping
no one would ask about. That is a problem for us. Our first
line and maybe our line of defense is really Customs. We do
have a working relationship with Customs, but it's very difficult
to police that, as I'm sure anyone would understand. If we
don't know it's coming, you know, it might as well be drugs.
If you don't have luck or advance knowledge, it's very difficult
to know. Now, if this is a company that has an existing presence
in the U.S., then we have a way to get a handle on them. But
if it's just a random maker, or even a large maker that is
located in a foreign country and is sending large quantities
to, say, individuals, that is very thorny problem for us.
FIFRA just -- I'm not sure. And on the RUP front, that is
one of our -- that is one of our priorities. In fact, when
we went through the surf day materials, that was one of the
first things we looked for, if not the first thing. We didn't
find as many as we thought we might. And we've had at least
one inspection. We sent out inspectors to the address of the
site that was offering all sorts of pesticides over the Internet,
and it turned out to be sort of a haphazard operation.
But that is sort of immaterial, because if you're selling
dangerous products, it doesn't matter whether you're sophisticated
or not. If you get them into the wrong hands, it's going to
be trouble. This site is no longer operational. They shut
down. Enforcement action is pending. The state asked to be
able to move forward first. So the RUP issue is a big one,
and we feel that that is one of the first things we go after
when we have the chance. And as far as the homeland defense
issue, I can't speak to that. That's not something I'm knowledgeable
about. Maybe Jack is.
MR. NEYLAN: Well, we are -- we actually are taking
-- and related to what Paul said early on. I mean, we're trying
to harmonize our data systems with Customs so that they --
you know, one of the problems before was just the way they
look at chemicals as more macro and ours are finer level of
things. And we're trying to match that up better. So that's
-- and they're clearly on the alert for that sort of thing,
and not just pesticides, but other chemicals as well. So there
is a lot of work going on in that area.
MS. MOOS: Okay. How about Julie Spagnoli, Beth Carroll
and then Bill Tracy.
MS. SPAGNOLI: I think another area of concern, at least
from a registrant standpoint, is general use products. They're
not restricted use, but they're definitely not intended for
nonprofessional use. In particular, it would be commercial
termiticides. And I think we -- you know, we know we've seen
it where there is this, you know, do-it-yourself pest control,
where they can buy commercial termiticides because they're
general use, even though the products clearly state on the
labels that they're to be used by professional applicators.
And I think the concern there, you know, is knowing that generally
there is very -- I think probably very few homeowners who
are going to have the equipment necessary to use that product
according to its label directions properly to actually get
efficacy. And I think that opens up some concerns for registrants,
obviously, that your product is almost going to, you know,
be misused or is not going to be efficacious and you have
potential liability from there.
And I don't know if that's another area that is being investigated,
because, again, it's not restricted use, but obviously not
going to the intended, you know, users when it is specifically
being directed to, you know, do-it-yourself.
MR. NEYLAN: I think that that's a problematic area,
because we don't have restrictions on the sale of those products
to those kind of people. I mean, FIFRA is absent that authority.
So you're really dealing with people then that -- you know,
trying to deal with stopping that. One of the things I think
we're going to try and do is send advisory letters to web
sites like that to sort of suggest they might want to change
their language if they're supposed to be directed to people
that are licensed to use termiticides, for example. And probably,
you know, put them on that kind of a thing. But, you know,
that's -- there is a problem with FIFRA in really dealing
with a sale.
MS. MOOS: Beth?
MS. CARROLL: I wanted to ask a question and then make
a comment. Do you have someone dedicated to monitoring the
Internet as far as looking for these illegal sites, or is
that a potential position that would be filled?
MR. NEYLAN: I don't think we're going to have anybody
necessarily dedicated. But I think we're going to have --
there are a lot of people who periodically do this, and I
think we'll continue to do surf days as a way of pulling these
up. But we really aren't quite staffed up to be able to just
do that overall. But as we've said, you know, we have 50 states
and some tribes that are interested in this, as well as our
regional offices. So there are a lot of eyes kind of looking
at it, plus, frankly, you all supply a lot of eyes, too. We
get a lot of tips from people.
MS. CARROLL: And that was going to be my next comment,
just to say that. The industry is very interested in making
sure that these illegal sales don't go on, and we're working
through Crop Life to assure that. And one of the reasons it's
really critically important to us is we can't steward these
products if they're being sold illegally. And that's especially
true when we look at it from the standpoint of resistance
management. And so I just wanted to bring that up as well.
It's definitely a stewardship issue, not only an illegal sale
MR. NEYLAN: Well, we're more than happy to take your
MS. MOOS: Thank you. Bill?
MR. TRACY: Did you give any consideration to phone
solicitations? As a grower, I receive a lot of phone solicitations
for pesticide sales. It seems to me that it would be a lot
more difficult to monitor that as opposed to the Internet.
MR. MEEHAN: We've -- the Internet we consider to be
sort of like catalog solicitation as well, and phone would
be another example. All require attention. We don't have,
you know, a solution to that now. But like Jack said, we're
more than happy to take tips and complaints. That's how we
found out about several of the sites that we have pursued.
And again, that's something that if we don't know about it,
we don't know about it.
MR. TRACY: That's a concern, especially as a Californian
who cannot apply without a PCA recommendation. And that's
what I always ask these solicitors and, of course, they're
solicitors and they don't know what's going on.
MR. MEEGAN: Okay.
MR. TRACY: They're just getting paid their minimum
MR. MEEGAN: Yeah, that's a problematic area.
MS. MOOS: Melody?
MS. DECALAMARLO: Thanks. I have two questions. One
is when you had mentioned the haphazard situation at the address
that you had investigated, it just reminded me that in my
work when we deal with people who make a lot of claims about
different things -- and I know that this happens to the FDA,
too. That when people do this, if they tend to get caught,
they close down and move kind of like hit and run. And I was
wondering if there was a way that you're going to be trying
to, you know, track certain people, especially repeat offenders.
That's question number one.
MR. MEEHAN: We would certainly like to be able to track
it. One of the things that we've spent a lot of time on as
we started to try and build our Internet program is looking
at ways that we can track the sites. Looking up, you know,
ISPs and web site addresses who actually owns the site and
who runs the site.
We haven't run into yet any situations where people have ceased
to sell and then set up shop under another name. But certainly
you could easily envision it happening, because it certainly
happens in other instances. In the particular instance that
we did look into, I don't think that has happened, simply
because it was such a small scale operation. It was somebody
who was essentially selling leftover pesticides from the place
where he worked, which was an actual pesticide dealership.
So I don't think he's done that. But it's easily enough to
envision it happening in other instances, and that is something
that hopefully the methods that we have developed will help
us deal with.
MS. DECALAMARLO: Okay. And then my other one was --
is more of a comment. I noticed that -- actually my mother
was a victim of mail fraud. I noticed that the Postal Service
has a web page where you can report these things, and I guess
the FDA must have something.
MR. MEEHAN: FTC has done a lot of work in that broad
MS. DECALAMARLO: So it would be really good if you
had a page on the -- on your web site where it would make
it easier for people to report such instances.
MR. MEEHAN: Yeah, that's an excellent idea. I agree.
MS. MOOS: Let me ask Tim if he has things he would
like to add, and then I think Dan will be next. Tim, have
you been able to hear us?
MR. CREGER: I'm still here, but I couldn't hear the
MS. MOOS: I didn't have one. I asked if you had anything
you wanted to add to any of these other discussions that have
MR. CREGER: Oh, I'm sorry. No, I really don't.
MS. MOOS: Okay.
MR. CREGER: No, I'll take that back. I have one thing
I would like to add. There was a question about whether there
was any full time staff that was doing constant monitoring
of web sites. Jack answered there really wasn't on the federal
I am aware of a couple of states that have actually added
staff in order to do this. An issue is with the California
Department of Pesticide Regulation. They collect a mill levy
for registered pesticides. And they have actually taken two
FTEs and added them to their internal staff, and they monitor
web sites that might sell products in the State of California.
And then contact them in order to collect mill levy for sales.
And so in a way that's monitoring of web sites in their activities.
I don't know how much success they've had with that. They
just started that last fall. And I'm also aware that there
has been some shifting of some state FTE resources from traditional
monitoring of sales, say in the dealer field level, to, say,
a quarter time or half time FTE, so that they can spend part
of their time looking at Internet sales, mostly on auction
sites like excessag.com and things like that. So there is
some going on on the state level.
MS. MOOS: Okay, thank you. Dan?
MR. BOTTS: Yeah. I was actually going to ask Tim a
couple of questions from the state level, because we've got
a pretty good overview from the federal side. I know just
from working in Florida, we've got -- our state pesticide
rules and regulations and law that govern distribution sales
and those things are different than other states as far as
exactly how -- what protections you have from where you buy
your product. If you buy it in state, there are certain requirements.
But if you actually buy it out of state, there are certain
things that you can get that may or may not be regulated at
the state level because of what's on the federal label. And
a lot of the stewardship issues that Beth was raising, and
some of the other things that have been tailored to 24C's,
are specific use instructions for specific geographical regions
that may or may not show up on things that are sold in a more
international level basis. How do you even attempt to try
to track that? Is there a licensing process contemplated for
being able to identify all these sites, and then for the states
where essentially it's an open ball game to go into, because
it's an Internet access type state where there are those types
of requirements to have any kind of tracking system to follow
MS. MOOS: Is this directed to Tim or to?
MR. BOTTS: Anybody who wants to answer it. If Tim wants
to try it first.
MS. MOOS: Okay.
MR. CREGER: Jack?
MR. NEYLAN: We have 24 --
MR. CREGER: Well, I'll go ahead and jump in the fire.
The simple answer is, it's a nightmare.
(End of Tape 2, Side B.)
MR. NEYLAN: -- that deals with this kind of an issue,
where this is the sort of thing we think if you're in the
business of selling pesticides or commercially using pesticides,
you know, that you ought to think about. You know, you ought
to -- if you have sales restrictions or other things, you
ought to make that perfectly clear on your web site and so
forth. Maybe we ought to -- we'll be probably talking with
the Pesticide Office about how to do something like that.
MR. BOTTS: Just to follow up on that a little bit,
because one of my primary roles is ensuring that my membership
doesn't get into trouble from the pesticides they use, from
an educational standpoint we have tried to push them -- or
our members -- into looking at the labels and supporting those
people that are actually doing the things in the State of
Florida that prevents those products from becoming a problem.
And if that same level of action is not taken at the national
level, there is a tremendous educational outreach effort that
Win and the rest of the people that are involved in those
kind of processes -- Crop Life and everywhere else -- and
the problem is not with registrant web sites that they're
talking about. They are individual products, because I can
tell you most of them have their 24C backups for state specific
labeling and those kind of things. But the few things that
I have seen just in passing and some of the e-mail solicitations
that we get as a trade association in attempts to go to our
membership, the classic was the one I got two weeks ago, the
guy from China who claimed to be the plant manager of the
new Methyl Bromide factory over there. He sent an e-mail and
said we understand that there is a phase out of production
in the U.S. scheduled for a certain time. We would like to
establish a business relationship for post-2005. (Laughter.)
MR. BOTTS: Which I don't think is quite legal. And
there is a whole universe of other groups that are going to
have to be engaged in that and Customs and other divisions.
But there needs to be some education back from you guys on
how we can deal with those kind of solicitations and requests,
so if we get something that is patently obvious on the surface
of it that it needs to be dealt with by somebody other than
us just hanging up on them, we need a name and a place to
MS. MOOS: Yeah.
MS. HARDER: I think Dan brought up a good point. But
I'm also concerned that this is a problem in the nonagricultural
pesticide use where I think there is a lot less control. So
it's something to be concerned about. And I don't know how
you go about educating them, because a lot of the structural
pesticide misuses that I've seen have occurred with people
who weren't really licensed.
MS. MOOS: Okay. With that, I would like to close this
session. I particularly thank Tim for being on the phone and
being available, but also Karen and Jack and Paul. I want
to move on to the electronic submission topic.
MR. CREGER: Thank you. Bye.
MS. MOOS: Bye, Tim. Our two presenters are Clive Halder
from Bayer and Kate Bouve from OPP's Information, Resources
and Services Division. We're pleased to have Clive join us.
He has pioneered the first full electronic submission with
EPA and PMRA, as well as the first electronic SES transport
file pilot with EPA. To date, Bayer has made two full joint
review electronic submissions and two comprehensive SES transport
file submissions. Clive has been with Bayer for 15 years.
Kate has been with OPP since 1989, and she is Chief of the
Information Services Branch of IRSD. That branch is the receipt
point for all of the studies that come in to support the registrations.
Kate has been working with both OPP staff and the registrants
on electronic submission activities. Again, I'm going to ask
that Clive and Kate keep their presentations to about 10 minutes
each so that we've got 15 minutes for discussion. And, Kate,
MS. BOUVE: Good afternoon. It's good to be with you
this afternoon and to have the opportunity to talk with you
about our efforts on electronic data submission and review.
What I would like to talk about briefly is give you some idea
about what got us going in this area in taking on some of
this new work. Give you some idea of some of the communication
efforts that this entails. Describe briefly the pilot efforts
that we've had underway in the program. Tell you want standards
we have accomplished in the program. And let you know what
the status is of our program, and then we'll turn it over
to Clive. First, a little bit of clarification. There have
been essentially two areas in which we've been doing piloting
in OPP. One has to do with the electronic submission and review
of study reports themselves. And then we've had -- and the
work on piloting that is essentially finished.
The second area we were looking at was looking at detailed
animal data in support of the chronic toxicology studies that
we receive in the program. That piloting effort is still underway,
and Clive is going to be going into some detail on that. Okay.
With that out of the way, why did we take this work on? I'm
looking back to the summer of 1999, and by that point in time,
I think both industry, data submitters and EPA reviewers realized
that we had to find more efficient ways and more effective
ways of handling the arduous tasks of assembling and submitting
data and then reviewing all that data. Also at that point
in time, certain technologies had emerged and were evolving
and were providing better tools for us to use as we tried
to attempt this work. We also were able to benefit greatly
from work that had been done especially by the U.S. Department
of -- the Food and Drug Administration, which has been doing
very good work in electronic data submission and review for
a number of years. And also our counterpart in Canada, the
Pest Management Regulatory Agency, had been working in this
area as well. We were able to learn a great deal from one
another, and it became a priority for OPP managers who urged
As we tried to decide what principles we should apply in setting
our standards, we knew that we had to strike a good balance
between the needs of the data submitters and the needs of
our reviewers. For the data submitters, they needed a standard
that would be inexpensive and easy for them to apply to their
work. Our reviewers needed a set of tools that would be easy
to learn, but powerful enough to help them do their job of
reviewing studies more effectively and more efficiently. We
also focused our attention on the studies, because this is
probably the most resource intensive aspect of the work in
the program. I think it's something like 40 percent of our
resources are tied up in the work of reviewing studies in
one way or another. So we felt that we would get the most
bank for our buck in this area.
Obviously, communication is essential in being able to introduce
a new way of doing work. First of all, we have benefitted,
as I said, from the Food and Drug Administration. They have
shared freely all the documents that they have developed for
guidance. They've trained our users. Our scientists have visited
there. My staff has visited there to see how they handle some
of the technical aspects of the work. They've been extremely
generous and helpful to us. In March of 2000 we had a very
successful workshop with ACPA, now Crop Life America. We had
great participation from industry folks, labs, FDA and Canada.
It was very successful, and it was a great leap forward for
us. We're planning another workshop in November of this year.
Individual registrants were fantastic. There were some specific
individuals who were -- within these companies who were real
champions of this effort and really helped us move forward.
And we also take advantage of opportunities to do presentations
like this to your group and to trade associations and others.
In the international areas I noted, we're working closely
with Canada, and we have a project under way with PMRA as
one of our NAFTA efforts on electronic data submission and
review, and harmonizing the standards that we're setting,
and sharing our experiences back and forth. Also, we're working
now in OECD, and we have a workshop that is planned in Ottawa
in October of 2002 to compare notes with North America and
the European community primarily. And, of course, there is
a lot of communication that has to go on within OPP itself.
We have an office wide work group that has been working diligently
to keep everybody together and be moving in the same direction.
We have to continually do these briefings for managers and
for staff. This is new work. It's a big organization. People
are busy. You have to keep communicating these messages over
and over. Change in large institutions is not easy. We also
have to make sure that when a reviewer finds themselves ready
to do an electronic -- review of an electronic study, they
get training and user support just in the nick of time. But
we also have to be collecting feedback from the reviewers
and from the industry folks, so that we can refine our guidance
and the tools that we're using.
In the fall of '99 we started our pilot. Of course, we built
a web site so that we had a way of communicating to data submitters
for the purposes of our pilot. What our technical specifications
were. What our guidance was on how to format their studies.
We had ready, willing and able registrants who stepped up
and took on this new work. We worked with both our reviewers,
who are federal staff, but also contractors who help us in
this area. We made a point of trying to do work with different
scientific disciplines so we had a good cross section of studies
in electronic format. And we developed an evaluation form
so we could collect the impressions and experiences of our
pilot reviewers, and they were uniformly positive. So what
are our standards? For study reports and for the submission
of those studies, we're using Adobe Acrobat PDF. This is not
brilliant. It's a pretty practical way to go. The submissions
are required to be coming into us on compact disc, and they're
coming in through the Information Services Branch. That is
my branch and that's the branch that does all the in processing
of all the studies and all the applications. So that way,
we're able to account for these officially.
And then from the reviewers' perspective, again they're using
Adobe Acrobat, but it's the full software package. Not just
the reader -- the free reader -- but the full software package.
And then in combination with our word processing software
and some other tools, they're able to evaluate the studies
and be able to meet all their criteria in terms of functional
requirements, and then it also helps them to prepare their
review documents. At this point in time -- in fact, in the
fall of 2002, we felt that we had been successful enough with
our pilots -- we were satisfied with the standard that we
had used for the pilots -- to then announce to industry that
submissions in PDF are encouraged. They're not mandatory.
We can't make them mandatory, but we very much encourage this
new way of submitting the information. So far to date, we've
gotten almost 800 studies. We have another hundred expected
soon. There are six more big submissions that are planned
for receipt later this summer. And in fact, we've been working
with some registrants that are looking in the out year. They're
starting to build applications and data submissions for like
2003 and 2004, and starting this work with this electronic
submission technique in mind. So I think that does it for
me. Now, we'll hear from Clive and hear about it from the
MR. HALDER: While we're waiting for the slides to be
set up, I just want to recognize Kate and her staff in the
Information, Resources and Services group. Projects like this
need more than one partner. There are two elements of that
and involve the customers of each other. And it's close to
four years now, I guess, Kate. Time goes, but it's been a
good three years where we've been working with EPA. And because
of the perseverance and innovativeness of Kate and her group,
in large part that has propelled the stuff forward. And I
appreciate that, Kate.
To keep within the time frame, I will be fairly superficial
and just give you the highlights of what I want to cover.
But basically I have three main objectives to cover. One,
to give you an industry perspective on electronic submissions.
You heard from Kate from the agency side. And basically the
problems I would say are almost identical, as I'll get into.
I mean, the resolution is a little different, but the problems
and concepts are the same.
I'll highlight some of the internal challenges and that's
what I eluded to. There are some, and the pharmaceutical industry
has certainly faced that ahead of us, and we are finding that
we are no different in that regard. And then I'll give you
an overview of the latest step in the development of electronic
submissions. And that deals with the supplemental files. Basically,
in order to make electronic submissions a reality, there has
to be a business benefit from both the agency's and the registrant's
side. And in analyzing those, going to the agency's side,
some of the key things that they are interested in is certainly
an increase in the speed of review. That doesn't mean less
intense. It just means increase in efficiency in the review.
Increase in access to information. And I think what we've
seen for the experience we've got so far, these two elements
are certainly -- we've seen the benefit from these two elements.
Increase in quality of submissions. The jury is still out
on that. That would be hard to know that just because it's
electronic the quality improves. But I guess it depends on
how we see it, and it will take a little more experience before
we know that that's a benefit. And certainly the efficiencies
in the review time. The backlog that the agency has and all
that. Any tool that will help with the review process will
certainly help with the resources.
Similarly, the registrants have some business need, and for
us it's to have an easy tool or set of tools to be able to
create these electronic submissions. Because if you don't,
all you've done is added to the workload. To be able to create
electronic and paper from the same source. Again, if you don't,
you're just doubling up your work.
And as we go through what we're discovering at the moment
-- or going through at the moment because we're in this interim
phase, we actually are doing double work, because we have
to take paper reports, a lot of times scan them, convert them
into electronic PDF and submit them that way. But ultimately
the goal is to have all studies generated from scratch electronically,
and then you're dealing with an electronic source and then
you don't have to worry other than print.
And this is important -- as important with any media, and
it will continue to be something that we have to watch, and
that's harmonizing and keeping stuff harmonized. If FDA had
a different standard or Canada had a different standard, we
don't care if it's paper or electronic. You end up going every
which way and that just creates extra work. So one thing that
we would be very sensitive to is making sure that we stay
harmonized to the extent you can be harmonized. And, of course,
it has to have economic value. Any time we can get a speedier
review through the agency efficiencies, obviously the registrants
gain from that. My goal within Bayer was -- in order to set
this process into place, I put this goal as my basic tenet
goal. And that is, I wanted to get the work flow and the change
made, so regardless of whether I submitted electronically
or not, I would get the efficiencies from electronic handling
of documents and preparation of reports internally. Because
without that, all you've got is additional work. I mean, the
submission part alone is insufficient to carry the value of
that, because there was a lot of hard work and rearrangement
of work flow.
And basically that is the number one issue, and it's no different
from the pharmaceutical industry. Overcoming resistance to
change is phenomenal, because an electronic tool is really
latent. I mean, just because you have PDF loaded onto your
desk top doesn't make you more efficient. It's how you use
it, and generally how you use it efficiently means you have
to change your work flow, and that's when you get into the
resistance area. It has taken about three years, but at this
stage we've got the process down to where people generate
the reports from start as an electronic -- what we call --deliverable.
Also of a lesser but still important issue is the changing
of the paper mind set paradigm. Before with paper, you know,
you may have your word processing and you write your text
and then you get a printout from some data collection system.
You put the thing together and you hand stamp the page numbers.
You have to change that process, because now you have to build
interfaces to make sure that you get all the other supplemental
additions in electronic form so you can pull all of this stuff
Some of these resolutions are expensive and hard to get. I'm
going to skip this due to time concerns. Kate had mentioned
that PDF is the EPA and Canadian and FDA standard. The Europeans
use a slightly different format called Tiff. Tiff is a little
less robust and has little -- has fewer functionalities than
what we see in PDF, and the basic deliverable would be a bookmarked
and hyper linked PDF file. Some of the functionalities that
you can get out of PDF are cut and paste, particularly if
you optical character recognize the document. That means they
can -- instead of having to retype portions of the report
when they're creating it, they can literally cut and paste
and then rework it as they see fit. You can link, so the navigation
is speeded up. You can go logically and say see attachment
A. You can go immediately to attachment A and then go back.
And the other thing that the agency likes is the annotation
feature of PDF. So they can write little notes to each other,
and then you can get a coordinated review of the report or
the document and be able to keep those annotations and keep
track of what you want to see.
Going to supplemental files, the reason where we saw a benefit
for making electronic supplemental files electronic -- and
I'll give you an example of a chronic study, which is probably
around 3,000 pages long. Of that, about 500 pages or less
is the text part and the summary. The rest are tables. A summary
and tables and individual animal data. It is this part of
the data -- we know that the agency rekeys certain files --
certain data sets of those so they can rerun and analyze it
statistically in the way they want. So using SES transport
files, it is just in a format that allows you to easily integrate
the SES transport files into SES routines so you can run statistics.
So instead of spending time rekeying data, they can take this
data immediately, because it's live, reorganize it the way
they want, select the sub-data set that they want, and run
their analysis. So it would significantly speed up the agency's
review. FDA has used that -- that file format -- and EPA has
adopted it. Canada has not. Canada at this stage does not
use SES in their organization at all, and so they're looking
I'll give you an example of what a SES transport file looks
like. It's not important that you see the detail there. But
it is an organized structure of all the data points that you
would have in your data collection systems. And there is a
tool out there called DBMS Copy that we were told about by
FDA that allows you to take different formats from your different
data output -- databases -- and convert them to a SES. So
you can get something in Excel and convert it to SES. You
can get something in ASCII and convert it to SES. And then
we provide these. This is what we've been working with Kate
and her group for a long time. It's to get the organization
in the format of these such that the agency just needs to
put them directly into their SES routine. The types of studies
that we have been able to do is basically all of the toxicology
studies of four weeks or longer. We don't think there is an
efficiency value on doing acute studies, because you can look
at the data in one page without having to go through all the
rigmarole of creating SES transport files. But we have created
SES transport files for all those study types.
And I'll give you an example of the types of data sets that
we have. At the moment since we're in a pilot, we kind of
are doing a grand sweep. We are anything that is -- anything
that is gathered, we are putting into a SES transport file.
Once the agency has some experience behind them, they will
be able to come back and say, look, we're not interested in
food consumption any further. You know, we'll do body weight
and mortality and micro pathology. The number of data sets
vary according to the study. Reproduction studies normally
have the largest amount. But they can range from seven to
54. These sets -- some of them are quite large. As you can
see, 31,000 lines or about six data sets per line. So that's
a lot of data. And generally our pilots to the EPA range around
250 studies, and we only do the toxicology studies at this
time. And that's it.
MS. MOOS: Thank you very much. Asking for questions
or comments? I can't -- yes.
MR. HOLM: I just wanted to comment that IR-4 has been
involved in this process for a couple of years on the pilot
part of the program, and we've been very, very pleased with
the agency's response and working with us. We have one of
our study directors that is really -- Jonas Carley -- who
has gotten quite excited about this. And I think we've submitted
-- or planning to submit 15 this year, and we continue to
see this as an opportunity to work with the agency on approving
our efficiencies and yours in our data reviews. So we commend
you for the hard work and effort and look forward to working
with you on the payoff.
MS. MULKEY: Bob, what -- do you all have any sense
of what kind of efficiency gain you are seeing? You hope to
MR. HOLM: Well, I don't think there are any efficiencies
internally that we perceive so far as far as us putting the
information together. But we're really trying to come up with
a -- you know, we still have to do the paper copy to the CD
and so on. And maybe we can gain more efficiencies and, you
know, as the previous speaker mentioned, then getting that
-- you know, working with it completely electronically.
But as far as review on your end, I think, you know, we've
been working with Jim and obviously people in the Registration
Division for the last couple of years and trying to have more
IR-4 petitions reviewed with the same amount of EPA workload.
And I think, you know, we've been able to go from about, you
know, 25 to 50 percent of your workload without any increase
in resources, which tells me that this component has had something
to do with increased deficiency within the agency in being
able to do that without any additional resources. So it certainly
appears to me that it's having a positive impact already.
MS. BOUVE: I want to just acknowledge IR-4's work and
participation in our efforts, and I apologize for not mentioning
you all specifically, because you really have been very enthusiastic
supporters of what we've been doing.
And I would also like to point out that Clive has been sort
of one of those individuals in a company who has been sort
of a champion for this idea and the whole idea of SES transport.
And he's had to deal with labs in the United States and in
Germany in order to get that information -- that data -- pulled
together, which is no small thing. So it's been a tremendous
MS. MOOS: Jennifer?
JENNIFER: Is the data coming in a form that you can
break it down and regroup and do your own statistics and make
your own -- you know, break the data into different groups
and start to look at it?
MS. BOUVE: The studies that come in, of course there
is a very large text component, and then along with it maybe
tables of information embedded in the studies themselves.
And with electronic submission, if it's developed in a fully
electronic way, our reviewers can expert data and tables and
slice it and dice it in other ways and sort of challenge the
assumptions that are in the presentation or results.
And then, of course, for the supplemental files, the massive
amounts of data behind those large feeding studies, we can
organize and reorganize that data in a wide variety of ways.
And that's part of what we're piloting, is what is the most
effective kinds of analyses that our staff are using, and
so that we can then make sure that others are using some of
the same tools or techniques so that there is a consistent
approach at analyzing this data.
We're still in the early stages of learning to work with this,
but that is one of the things we hope to be able to do.
JENNIFER: Well, it's not really so much working with
the electronic data, because that's -- I mean, I haven't done
anything but Nialock electronic data since, I think, '92.
So I would imagine any data that is ever generated has to
be converted to paper. Printed, so to speak. And it's all
done -- like everything is done electronically, because how
else could you do large scale statistics on it. So I don't
see working with the electronic form is the new part here.
I see working with the data. So I guess my question to you
is, are you getting it in a more raw form? Or maybe in a finished
form, but are you able to break it down to the raw form and
manipulate it more?
MS. BOUVE: Well, if data is presented to us in a study
report in a series of tables -- for example, say, the results
or the final conclusions or something like that -- in the
past if the EPA reviewer wanted to analyze that information
in different ways, they would have to rekey all that information
MS. BOUVE: -- into their own spreadsheet --
MS. BOUVE: -- software which is very time consuming.
And yet if you really want to do a good job of analyzing the
study, and as part of your review and your assessment of that
study, you needed to do that and it was a very time consuming
tedious kind of a task. That step we are able to bypass now
by virtue of getting it in an electronic format.
JENNIFER: That's true.
MS. BOUVE: So even that is a very big savings for us.
JENNIFER: That is. That's great.
MS. MOOS: Terry?
MR. TROXELL: Yeah. I don't know that my comments are
going to add too much to this. But it's good to hear that
FDA has been so helpful in EPA establishing this process.
You know, I guess it's not going to be too many years until
we won't have really any paper around at all. But it's a matter
of people getting used to electronic format. I mean, we had
the days of filling in libraries full of paper and having
to check these petition parts in and out one at a time. One
reviewer, you know, at a time. To now with the electronic
version, the efficiency is that multiple users can be looking
at the same item at the same time. You can have teams of reviewers
looking at the items together on different computers. And,
you know, in the Washington area -- those of you who don't
live here -- we have, you know, kind of a traffic problem.
And there is a lot of desire for people to telecommute, whether
it be from centers or from home, and this really facilitates
working on projects from the home, saving all that time --
travel time. And actually, you know, making people's lives
better, but also more productivity for employees because they
can get -- you know, a few of us bureaucrats, by the way,
actually -- only work 40 hours, so we can actually get more
time on projects.
But then there is the other side of the coin, and that is
the security of the documents. Because once they're electronically
accessible, one has to have very secure systems so that they
don't get lose on you because they're flying around the Internet
and on people's computers, you know, working at home and so
MS. BOUVE: I think the security issue is certainly
one that is a big challenge for anybody who is dealing in
this arena. We -- that's why we have the studies coming in
on compact discs, because we don't -- the agency is not prepared
to handle electronic submission via Internet or some sort
of telecommunications mechanism. Plus, I don't know how many
registrants would feel really warm and fuzzy about trying
to send over the wires an enormous submission of, say, 230
studies or something like that. That would be sort of nerve
wracking and a scary way to submit data, I think. But teaching
people about how to do the secure -- to handle these documents
securely just as they would with paper is a challenge. It
may seem different because it's a different media. It's certainly
a heck of a lot easier to walk around with a CD than it is
with a 4,000 page study. So it is a real challenge for all
MS. MOOS: Are there any other questions or comments?
Oh, I'm sorry. Alan?
MR. JAMES: On a related area, there is progress being
made at the state level as well. It is enormous what we have
to submit to EPA. But there are 50 states out there, and all
50 seem to have different requirements for registration of
our annual registrations, and also the many, many thousands
of label changes of that nature that go on at the state level
each year. There is some progress being made there. Most of
it is real good, but the issue of security has come up. How
the data is going to be electronically transferred to the
states. There are efforts now in some cases to have a central
organization provide the software and handle the processing.
Some legitimate questions have come up about whether moving
your data through third party networks is an appropriate and
secure way of doing that.
So there are some issues that will need to be addressed at
the state level. I think the concept of doing it all by diskette
probably is -- for the short term, at least, gives me more
comfort than the kind of descriptions I've received so far
of what is being proposed at the state level.
MS. MOOS: Julie?
MS. SPAGNOLI: Another area that I know was talked about
as far as electronic -- I guess it's not data submission so
much, but the electronic labeling -- electronic label submissions
-- and being able to do comparisons for, you know, label amendment
review. There was an effort underway in that. Is that still
underway in looking at -- trying to find some standardized
format, or some standardized way of submitting labeling as
well to ease review?
MS. BOUVE: Yeah. Yes. Tom Harris in the Registration
Division has been the leader of the effort there. The idea
is to get the text of an existing label in PDF and then a
PDF version of the proposed amended label language. Adobe
Acrobat gives you the capability to do a compare function,
which will spike up any differences in the language between
the existing label and the new proposed so there is no confusion
about exactly what change is being requested.
Our Registration Division has done a lot of good work in trying
to promote that, but unfortunately a lot of companies haven't
taken them up on it. We wish they would, you know, do that,
so chat that up.
MS. MOOS: Alan, did you have something to -- oh, okay.
Steve. Thank you for the prompt.
MR. BALLING: Well, actually I just wanted to comment.
That was an interesting issue from the user perspective. One
of the things that we do -- and I know a lot of other companies
do. It's something that anyone who uses pesticide compounds
needs to be aware of. And that is trying to manage label changes.
Every year we put together an approved pesticide list for
each of our crops. We run through -- we have to look through
every label and try to see if there are any differences in
that label. And you've got to compare for each crop, each
use, all the timings and all of that. It's a tremendous effort.
We've been trying to move to something more real time, where
we have on our own intranet site all our pesticide lists.
If every time there is a change in the label, that information
is readily available so that we can go onto a site and look
for label changes that were easy and you could do a compare
function or whatever, then we could have a real time approved
pesticide list available at all times for our field men and
growers. That kind of information is really valuable as opposed
to trying to get hold of labels from, you know, Internet sites
that the companies have and they're always out of date and
who knows what is timely. That would be a wonderful opportunity.
MS. BOUVE: As we look ahead -- I mean, obviously we
still have a lot of work to do in the study arena. But as
we look ahead to what would be the next really smart opportunity
for electronic submission. But also exchange. Sharing information.
And it probably -- we haven't, you know, consulted with all
our internal or external customers yet.
But our thinking from preliminary discussions is that label
-- detailed information about what's on the label -- the sites
and the pests -- in a structured way that feeds from our database
to our database -- hopefully to the databases of the registrants
-- we feel that there is probably tremendous potential there
in being able to share that information. Being able to process
it quickly. Keep our databases up to date and the like. So
that's probably --
MR. BALLING: That would be better.
MS. BOUVE: -- the next opportunity to explore.
MR. BALLING: If it's in a database format as opposed
to trying to compare labels, so much the better.
MS. BOUVE: Absolutely. Absolutely.
MR. BALLING: That would be fabulous.
MS. MULKEY: It's nice to see some energy forming around
this issue. In our view, it warrants it. But we're past our
break time. I think we're okay on time. If you opt not to
come back, you won't get to have a part in the discussion
about where we're going to put our attention in the future
for this committee. So we hope that's enough of an incentive
together with the good goodies that are still out there.
If we come back at five after, then we're back on time. We
can end in plenty of time. We can have our -- admittedly out
of our own pocket -- happy hour on time. And so we'll come
back at five after. We'll use that time, if you folks can
stay, for a little wrap up of this topic when we get back,
because it warrants a little bit.
(Whereupon, a brief recess was taken.)
MS. MULKEY: My take away message from all of you is
you share our unease about the implications of the Internet
for safety, lawfulness and security involving pesticide products
in the United States. And we would be interested in your feedback
as we go forward about whether there are any networks, partnerships,
follow along projects or other activities that this group
could or should facilitate. You see -- you've got some sense
of our level of effort, the level of effort in the states,
our attempts to partner with the Federal Trade Commission
and other federal agencies, and our effort to facilitate your
tips and other engagements with us. But I suspect you also
got the sense that we are extremely limited in our capacity
to manage this, and that frankly it will not be successfully
managed if left to law enforcement as the only tool that we
And so there is some possibility that something beyond the
information exchange we engaged in might be a possibility,
and we'll look forward to some further engagement on that,
and our chat and the possible follow up.
With respect to the second topic, I know even my eyes cross
a little bit when we get to this SES format stuff. But I will
tell you why I stay awake in this. Of all the issues that
have come to my attention in the time I've served as Office
Director, this is the single most dramatic and it has the
potential to impact our efficiency and our quality, and to
impact it at a level that will be noticeable in terms of real
results. Now, I would be startled if the 25 to 30 percent
efficiencies that we have gained in the IR-4 submissions are
primarily attributable to this factor, because this factor
came fairly late in the game. But I would not be startled
if at the end of the day we learn that this when fully implemented
is gaining us those kinds of efficiencies. That, folks, is
dramatic, and it has positive implications regardless of where
you're coming from as you sit around the table.
If your interest is in newer, safer chemistries, it has positive
implications. If your interest is in -- is a business interest
in the registration production flow, it has positive implications.
If your interest is in more tools in the toolbox, it has positive
implications. So I think it is -- if your interest is in more
rigor in our science and more care and a greater soundness
in our science, it has positive implications. So I'm hard
put to see how it is other than good for everybody, and I
believe that as companies go fully electronic, rather than
dual track, they also will gain some of the kinds of efficiencies
that may lower the price of these tools to all of us, or raise
their stockholders gains, or something good for somebody.
Make for better bonuses at the end of the year or whatever.
It just seems to me it's one of those things that nobody loses
and everybody can win. And so again, there may be some opportunities,
maybe for parts of the industry that are not the big R&D.
Maybe some of Warren's members, or some of Alan's members
who are nevertheless in the registration application business
to get engaged. Certainly some of Gary's colleagues and so
forth. So there may be some opportunities around the table
to learn from this, but we wanted all of you to get a sense
of it. And so I want to thank Lin and to express my delight
that she is back in the pesticide fold, and to offer you one
last chance to speak to this topic before we move on. Okay.
Thanks a lot. We now are scheduled to spend about half an
hour on four topics that have been identified, either by you
or by us or both, for potential future consideration. And
by that, I mean more comprehensive consideration. Consideration
beyond updates in a minute and with a special focus on this
forum as opposed to other forums as an appropriate place for
some extended dialogue. These topics, as I said, are identified
in part because some of you identified them, and in part because
we had some interest in them. I want to spend a minute or
two on our vision of what these topics -- what their scope
might be, which is not to limit that, but at least give you
some sense of where we would be coming from.
Alternative testing issues can be very broad spectrum in terms
of what people mean. They can go all the way to -- this was
a new word I learned and now I've already forgotten it. Something
toxicology. Think. Basically figuring out a way to do toxicology
without animals. You just do it on a machine. What is it?
FEMALE SPEAKER: Computational toxicology.
MS. MULKEY: Computational toxicology.
MS. MULKEY: Which I think is way beyond the scope of
this group of mostly nonscientists to discuss. All the way
to the more nuts and bolts kinds of things about alternatives
to animal models that are either had been validated or in
the process of being validated to questions about how to be
sure that the testing that is done is necessary and that we
have things like tiering and workable waiver processes and
so forth. But the reason we put the topic here was to focus
on alternatives to the animal models in sort of a practical,
available in the near term, operationally possible within
our program. So that was the scope we had in mind, but I'm
just acknowledging that this is a topic that has an extremely
There is a lot of interest in biotechnology, genetically modified
organisms, and there are a lot of other forums for that, including
USDA has an advisory committee that puts -- well, I thought
you already had one.
MR. JENNINGS: Soon we'll have it recharted.
MS. MULKEY: Oh, it's recharted. Okay. I didn't think
I dreamed that. But there is a federal advisory committee
that works on these issues. We have SAPs on the science of
these issues. There seem to be some special interest in the
allergenicity issues. There are some really difficult, hairy,
medical, science issues around allergenicity and biotechnology.
We have had very dense, rich SAP meetings. This is, again,
not a forum for a discussion of the science. But within our
agency, there has been more lay interest in sort of just generally,
how do you think about allergenicity. So there is a possibility
of having a dialogue aimed more at a lay understanding of
this issue. So that's what we had in mind for that, rather
than a forum in which we try to understand what kind of models,
animal or otherwise, there are to fully and comprehensively
analyze allergenicity and genetically modified organisms,
or anything else for that matter.
Ecological risk assessments is something we've always done.
There was a subcommittee of the PPDC which put a great deal
of work into probablistic risk assessments. We continue to
do these risk assessments. They continue to create results
that we struggle to understand how to implement and risk management.
We continue to have relatively infrequently pesticide analyses
where the ecological risks are sufficiently compelling that
they are an important component in our risk management decision
making. And so the idea of an update on where we are on ecological
risk assessments and where we're going -- again, not the detailed
science of it, but the thrust and approach -- is there. And
then registration review is that part of FQPA which basically
says when you finish
reregistration, or independent of reregistration, for all
of those products not subject to reregistration -- in other
words, for everything post-84 and for the next cycle after
you finish reregistration, we anticipate an approximately
15 year cycle of updated testing and review of the continued
appropriateness -- safety standard -- of registered pesticides.
And that we are beginning -- it's time for us to begin to
have in place that program. We've done an advance notice proposal.
And we could have a discussion about our thinking and next
steps and get input on that.
So that's what those four topics are. But we can talk now
about those four or any others, and also use this time for
a little bit of feedback from you about format, approaches,
or how to make this committee the real working, useful committee
that we all want it to be. So I'll stop now and let you guys
talk a while. Steve?
MR. BALLING: One quick question on the genetically
modified area. Does EPA get involved in the issue of advantageous
MS. MULKEY: Yes.
MR. BALLING: Because obviously that's a very hot issue
right now, or becoming a hotter issue, not just related to
allergenicity, but the fact that it's presumably unregulated.
I think that seems to me like it would be an area of great
interest to this group.
MS. MULKEY: But one of the difficulties in talking
about anything about genetically modified organisms, the EPA's
role is with the ones that have pesticidal properties, and
all of the rest of the responsibility for looking at the impacts
of genetically modified organisms lies in other federal agencies.
MR. BALLING: Well, the two I'm aware of that have hurt
the food industry are pesticide related.
MS. MULKEY: All right, fair enough. Two?
MR. BALLING: There is this current canola issue out
MS. MULKEY: With respect to the ones where we are doing
-- we do look at it. And in fact, our registration for Bt
cotton limits growing in areas where wild cotton plants are
known to grow. So that's an actual regulatory choice based
on advantageous presence. The difficulty is that the science
questions -- and a lot of the public policy questions -- around
advantageous presence go beyond the plant pesticide issue,
and even the ones that have to do with advantageous presence
in the food supply. There is some -- and I'm not close enough
to it to know the details. There is some interagency work
on this issue.
So I think the real question is, how expansive ought the Pesticide
Program Dialogue Committee try to get around biotechnology
issues that are not pesticide specific. And frankly, my --
MR. BALLING: Well, we have Terry here, of course.
MS. MULKEY: What now? Yeah, we have Terry. We have
MR. BALLING: He would actually wake up.
MS. MULKEY: We have both the other federal agencies
with responsibility for this. But I think this might be an
MR. BALLING: Okay.
MS. MULKEY: Okay. But there is this other forum.
MR. BALLING: I'll abide by that. A couple of other
things I would add. One that has come up recently in some
discussions with commodity groups in California and with the
western region pest management center is the issue of these
pest management strategic plans and how EPA actually uses
them. Whether they're used, because they are a tremendous
amount of work and fairly costly.
And we don't have a real sense -- I mean, some people say,
oh, yeah, we use them all the time, and other people say,
oh, they never use them. And so it would be nice to have a
report from your HED and R&D and whoever else.
MS. MULKEY: BEAD.
MR. BALLING: BEAD and everyone else on how those are
used. And then another one that came up yesterday, and maybe
it's -- I don't fully understand how it is being dealt with.
But I would be curious if it's being dealt with by some work
group that I don't fully understand, maybe a report from that.
And that's reentry intervals and the concept of activity based
reentry intervals versus just the single REI per crop. That's
very important as these REIs get extended when, you know,
you've got a 45 day REI based on something that is going to
be machine harvested. Those are big issues for us.
MS. MULKEY: Well, that issue is a risk management --
it's like a refined risk management issue and that's something
we probably could have a discussion on.
MR. BALLING: Okay.
MS. MULKEY: Okay. I know -- I don't know in what order,
so I'll just go down the line. Gary?
MR. LIBMAN: Thank you. I think we had some great discussions
earlier today about pesticides and maybe we beat it to death.
I don't know. But I think we didn't, and I love to see in
a follow up meeting some further discussions. Maybe a follow
up discussion. There were some great ideas that were given
to me by the panel members, as well as the agency people,
and I think that I would like to see this pursued. I would
not like to see it dropped at this point in time, because
I think it's a very important subject. And because of the
key issues that came up with USDA and the EQIP and so on,
I would very much like to see some type of a follow up on
MS. MULKEY: Ray?
RAY: Thank you. I also appreciated the discussion today
on the biopesticides and the fact that a substantial chunk
of the meeting was dedicated to that with the presentations.
And I would suggest a similar format for alternative testing
issues at a future meeting, perhaps the September meeting,
particularly to focus on some areas where short term replacements
might be a possibility. There is an extraordinary amount of
work being done in other countries and other jurisdictions,
which have in fact accepted replacement alternatives to animals
for some of the endpoints which OPP requires. So that sort
of discussion taking place at a future meeting, I would strongly
encourage. I would also strongly support a review of the data
requirements for various classes of pesticides to ask the
question whether we could possibly get by with less data or
different types of data, as well as an ongoing review of some
of the longer term replacement options. Some of the R&D
that is going on in other jurisdictions for nonanimal methods,
be they in vitro, computational or other sorts of technologies
that could reduce or replace animal use further down the road.
This would need to be an ongoing discussion and it's not really
amenable to an update in a minute kind of format. So it had
been discussed at the last meeting, and I would like to revisit
the possibility of establishing a work group that could review
these issues on an ongoing basis, that could be more technical
in its focus to explore the technical aspects of it, looking
at in-house activities through the EPA's Office of Research
and Development, as well as efforts in other jurisdictions
to develop and validate some of these methods and serve as
an ongoing coordinating capacity for the agency.
MS. MULKEY: Beth?
MS. CARROLL: Just to follow on a little bit with data,
presumably by the next time we meet -- and I don't -- if it
is September, that would be perfect timing. The agency will
have received feedback on the draft document on how it plans
to comply with the Data Quality Act. And I would like to see
that added to the discussion for the next meeting. MS.
MR. STICKLE: I would like to raise two or three questions.
First of all, the inert risk assessment model for inerts that
we've just gotten today, perhaps you'll have a 90 day comment
period which will bring it sometime into perhaps early August.
At some point, the agency is going to need to look at the
800 food use inerts that are up for tolerance reassessment.
So perhaps after we've gotten through the comment period and
we begin moving into the next phase, perhaps we could put
that on the agenda to discuss how that might be implemented
and where it might head. I would also agree that the Data
Quality Act -- the comments are due on May 31st for EPA and
has to be implemented by October 1st -- is a real ripe timely
topic for discussion. In other words, what are the implications
for data. What are the implications for OPP, for R&D,
for AD, for endocrine and a whole variety of other issues
and how that might all fit together. And not for the next
PPDC meeting, but perhaps for the one that follows that. You
mentioned earlier that the NAFTA TWG group is getting together
in December in New Orleans to talk about the next five years
and plans for both agricultural and nonagricultural issues.
So at some point in early 2003, I would recommend that as
a discussion point on what the issues might be. But only after
you have gone through that annual report in New Orleans.
MS. MULKEY: Okay. I'm going to go to Lori.
MS.BERGER: Okay. I just had a few things. First of
all, I really appreciated the advance notice of this meeting,
and maybe that's one reason why we had really good attendance.
And I also liked the update in a minute format. I thought
that was very interesting and kept moving. I really liked
that format. I would, like Steve said, like to hear from EPA
folks and USDA about these pest management strategic plans.
How they are helpful to you. How we can improve them, because
we are putting a considerable amount of effort into developing
these, mainly for you guys. We feel a lot of benefits for
our commodities, but we want to optimize that process and
And two other things. The activity based REIs, this is a critical
issue that we need to visit. And then finally on biopesticides,
I did enjoy that discussion. And this might be way off, but
it sounds like there is a lot of commercial limitations to
these smaller companies that are using these products.
Are there any government programs that could help some of
these companies or projects of this nature if this is really
a way that we want to encourage pest management to go. I mean,
are there any opportunities within the system to encourage
entrepreneurs in this area.
MS. MULKEY: You mean like the Small Business Administration
MS.BERGER: Yeah, something like that. I mean, I know
that there are other -- I know with manure treatment and water
treatment there have been similar programs, and I wondered
if maybe there might be something along those lines for biopesticides.
MS. MULKEY: (Inaudible).
MS. POPOWITZ: Yes. I'm really encouraged by your interest
-- by the agency's interest in pursuing short term replacements
for the animal testing required under FIFRA. And to that end,
would like to propose that Proctor & Gamble, that has
a lot of experience in doing nonanimal risk assessments, would
be willing at your next meeting to give a presentation on
our methodology for doing that in the acute tox endpoint area.
Basically, you know, what we do for our nonFIFRA products,
which essentially, you know, is what you do when you look
at a six pack.
In 1996 we made a commitment on our nonfood and nondrug products
not to conduct animal testing any longer unless required by
the government. And as a result, in the U.S. our FIFRA regulated
products are the only products that we still conduct animal
testing on. And in many cases, it doesn't make a lot of sense
to us, because often these are household cleaner formulations
previously regulated under CPCS for which we didn't need to
do animal testing to commercialize. But moving them to add
an antimicrobial claim, puts them under FIFRA and causes us
to generate animal testing. So we're very interested in the
issue and have a lot of experience, as I said, in not only
conducting the nonanimal risk assessment method, but have
spent almost to the figure of a hundred million dollars on
research in this area. So we have a group of research toxicologists
who have focused on in vitro methodologies. And the state
of the science has moved considerably since your data requirements
were established, and I think there are some methodologies
that could be readily accepted if there was a good process
for reviewing them.
I would also be interested in the agencies articulating what
OPP's animal welfare policy is. There are statements of policy
in the OPPTS acute toxicity guidelines, for example. OPPT,
as part of their high production volume challenge program,
has animal testing principles. It's not clear whether OPP's
are consistent with that, and the implementation clearly of
those principles is made more difficult by the fact that they're
not codified. And in discussions we've had with the agency
in the past, it has always come up that codification of those
principles would enable more ready acceptance of alternative
MS. MULKEY: Thank you. I'll answer one little part
of your question. We hope in this year to propose
-- well, propose an update for our data requirements, part
158, and in connection with that proposal, we expect to highlight
this issue of animal conservation, and welfare considerations,
and minimization and appropriate reduction of animal models
There will be some -- a few, quite frankly. Very few specific
provisions in which we may be able to point to a proposed
change. But we're going to invite comment and also articulate
our general principles. So that is a forum we hope that we'll
have this year in which we will have a more systematic opportunity
to speak to this issue.
We do -- on occasion you will see a PR notice we did on duck
Hepatitis B virus testing and some other places where we stated
-- we have made public statements.
(End of Tape 3, Side A.)
FEMALE SPEAKER: -- than on nonanimal risk assessments.
MS. MULKEY: Well, I was just going to wait until we
FEMALE SPEAKER: Okay.
MS. MULKEY: Because several people have raised that.
I just wanted to answer just that narrow point.
MR. HOLM: I would like to support Steve and Lori's
comments about the pest management strategic plans. I know
the commodity groups have spent a lot of time and effort.
I know Al's group has gone out and helped organize these meetings.
Usually 20 to 30 people attend for one to two days. IR-4 has
been sending members for about a year.
And one way we've hooked into the program is that we've told
the commodity groups that if they prioritize and come up with
a list of priorities, then we will take the top priority at
our next food use workshop for an IR-4 project. So that's
provided a good hook to the system. But I think there may
be a lot of information that comes out of those programs that
could be used more broadly, and I would like to maybe have
this group explore it, and certainly have the agency look
at it. I agree with Gary. I think there are some opportunities
for following up with the biopesticide presentation. I think
Janet and Kathleen and Pat have done a good job of capturing
a lot of information. But if it just sits there without any
recommendations for implementation, it won't go anywhere.
And I think if we've got some momentum going, it would be
good to follow up.
And then the final comment I would have was -- and I know
it's sort of in the purview of TRAC and now CARAT to look
at FQPA transition. But I'm just wondering if this group might
play a role in the transition process, whether we could have
some participation in the transition working group or whether
somehow this group could support that effort.
MS. MULKEY: Larry?
MR. ELWORTH: I may be the only person in the room that
is really interested in registration review. I think -- I'm
actually interested in how you all have been thinking about
it. Maybe we can talk separately.
MS. MULKEY: I'm not sure about that. A lot of people
in the room have taken our side.
MR. ELWORTH: Okay, right. I think they do. I'm just
kind of -- it seems like it's an esoteric issue that, you
know, nobody paid a whole lot of attention to in the statute.
But one of the ideas behind putting registration review in
there was to give the agency a backstop on granting registrations.
So where registrations were -- I know there had been concern
within the agency about granting a registration, and then
if problems appeared in the future, it would be very hard
to get it back off the market.
DISPRA provided a way for the agency -- a regular place for
the agency to review decisions, so that if problems did come
up, there was a way to deal with them, both on the back end,
but also to provide some comfort level on the front end in
MS. MULKEY: There is also the issue of systematically
updating the data.
MR. ELWORTH: Sure. Right, right.
MS. MULKEY: So that there is sort of a level playing
MR. ELWORTH: Well, sort of to avoid the FIFRA 88 kind
of crash. So I'm interested in that.
I would like to put this issue of the pest management strategic
plans in a slightly larger context while they're important
in and of themselves. There are things that the agency does
besides the risk assessment in BEAD for looking at what the
impacts are, both in terms of the pest management strategic
plans, where the alternatives are, and also maybe to some
sense the way in which the agency assesses risk mitigation
options, both on the risk side, but also on the BEAD side.
So I would like to actually put the pest management strategic
plans in that context so that we can understand that in terms
of BEAD's activity.
The other thing I would be interested in, while I'm interested
in the biopesticide piece to this, I am interested in the
discovery side with the -- I don't know what we call them
now -- conventional chemicals to the extent they're reduced
risk. But I'm actually interested, and I wonder how many people
have actually had a chance to look at the way the larger companies
do their discovery process and how that actually takes place.
Maybe all the people from the registrant side know it really
well. But I think it's pretty interesting the way in which
that takes place and how registrants actually decide to bring
compounds to the agency and how they make those cuts. It would
be really interesting to me. And also I think that computational
toxicology is -- when you said that I thought, god, that's
the way I feel at the end of every day in front of my computer.
MS. MULKEY: (Inaudible).
MR. ELWORTH: Right. Anti-virus.
MS. MULKEY: And computation. Win?
MR. HOCK: Yes. If you will indulge me just for a moment,
I want to just read something. In Merced County, California,
thieves intent on stealing from agricultural operations deliberately
trigger an alarm on the premises and then flee. They wait
until after the Sheriff's deputies have investigated and left.
Then they quickly return and take the agricultural chemicals,
equipment and hay they had originally targeted. This is just
one of many examples of a growing problem in agriculture in
California and elsewhere. Crime aimed at agricultural perations.
And this comes from the Gimbler's Alert Newsletter that I
get electronically and it's kind of enlightening. After I
read that, I just was wondering. I would like to see someone,
maybe from the Office of Homeland Security, discuss this whole
issue of security of pesticides. I have no clue. Are they
doing anything? Are they addressing the issue, the movement,
the sales, the transportation, the storage of pesticides?
Are they concerned at all about e-commerce?
Another example would be that we do not -- or at least many
states don't ask for a positive I.D. if someone works into
a dealership and buys pesticides. Anybody can go in as long
as they have -- if it's an RUP. If they have a certification,
they can get it, but they don't ask for any kind of identification.
And I'm just curious. Is the Office of Homeland Security doing
anything in terms of -- and I'll put it in quotes -- "pesticide
security management." And I know from a previous meeting
I attended, Steve Johnson, I believe, has visited with Governor
Ridge and his staff about this very issue. And I'm just curious
what is going on. You know, how does EPA or how can we interact
at the state level with the Office of Homeland Security. So
that's an area that I am particularly interested in. I just
throw that out as food for thought.
MALE SPEAKER: Excuse me, Marcia. Marcia? Could I add
a comment to that.
MS. MULKEY: Of course.
MALE SPEAKER: In fact, the Homeland Security office
on Tuesday and Wednesday of this week here in Washington at
the Rand Building held a two day conference on security issues
and safety issues, and we spent two days talking about chemical
issues and pesticide issues. In fact, there were a number
of people from EPA, as well as a number of people from a variety
of different parts of the industry. All the trade associations
in the pesticide industry were essentially represented there.
So, yes, they are doing a great deal. And I would be happy
to provide the information to you, and perhaps someone in
your group could get plugged into that.
MR. HOCK: Okay.
MS. MULKEY: And when we come back around, I was going
to mention a few things.
MR. HOCK: Thank you.
MS. MULKEY: Julie?
MS. SPAGNOLI: Larry, there are other people interested
MS. SPAGNOLI: And in fact, kind of a combined maybe
even -- you know, Beth brought up about the Data Quality Act.
And I think maybe even to see how the Data Quality Act may
relate to registration review.
I think the other issue with registration review would be
-- you know, we know we are still going through tolerance
reassessments. There are still a lot of tolerance reassessments
left to be done. And, you know, how could they tie in some
of the tolerance reassessment activities with, you know, registration
review on products that will be undergoing tolerance reassessment.
You know, is that part -- you know, would that be considered
part of their registration review and how does that -- you
know, how does that process interrelate. Just like reregistration
and tolerance reassessments where they kind of intertwine.
And then I think in the area of alternative testing issues,
I think another area to be investigated is alternatives to
testing. You know, we worked with the agency on a policy for
basically a blanket waiver on acute toxicity testing for products
on granular fertilizers, that, you know, there was no reason
to keep testing fertilizer over and over again with this products
that had low levels of active ingredients on fertilizer.
And, you know, are there other opportunities to look at. Classes
of products where there is enough data available on -- you
know, almost on an entire class of product to kind of make
a judgment that would allow us not to, you know, have to continue
to, you know, reevent the wheel of continuing to test to see
the same effects.
MS. MULKEY: Okay. I think I'll just run again and pick
MR. QUINN: No. What Julie just said, I think that's
something that companies that I'm working with would be very
interested in as well. And just so, you know, Proctor doesn't
appear to be alone here on the industry side as advocating
a focus of this group on alternative testing, I know two,
maybe three, companies that I'm working with that will be
very interested in participating if there were a work group
of some kind, Marcia.
And then just a follow up on your comment about 158. I think
that's a great opportunity to go ahead and sort of reinforce
what I guess we could call the Whalen letter principles within
that document, and also perhaps institutionalize some way
for the agency to look at validated alterative tests and then
put them into place, which simply doesn't exist right now.
And that may be -- that may sound ambitious for a rule that
is as far along as it is. But I think quite a bit of thinking
has been done about that, and I would be happy, you know,
to chat about that if there is still an opportunity.
MS. MULKEY: It is a proposal.
MR. QUINN: Right.
MS. MULKEY: So if we tee up the issue adequately, it
will be possible to go final around some things that may not
be fully fleshed out in the proposal. Bill?
MR. FREEZE: Yeah. I would like to encourage the group to look
at the pesticide producing plants and allergenicity, one of
the topics here. As everyone probably knows, allergenicity
has been one of the main concerns of genetically engineered
foods for a long time with the main health concerns. And there
have been lots of workshops and papers on the subject dating
back to -- I believe the FDA had a big workshop in '94. Scientific
Advisory Panels have looked at it, as well as, of course,
it was the issue with Starling corn.
There have been several protocols that have been put forward,
most recently at the UN level. The Food and Agricultural Organization
and the World Health Organization came out with the most detailed
protocol to date which has international support. And I think
it would be a good idea if -- you know, I think we really
need to begin to apply such protocols for, you know, these
new pesticide producing crops that will be, you know, coming
down the line. There were four Bt crops reregistered last
year, and unfortunately none of these protocols were used.
They basically were not assessed for allergenicity. There
was a lot of new evidence that came up that wasn't really
considered. So I think it's -- you know, it would be a really
useful topic to address and to come up with some firm standards
hopefully that the EPA can apply in future assessments of
Bt crops. And my name is Bill Freeze. I'm with Friends of
the Earth. And I have some comments that I submitted to the
EPA that I would be glad to share if anyone is more interested
in this subject.
MS. MULKEY: Bill Tracy, I think yours will be the last
word for this session. There will be time tomorrow to talk
about this, and I'll be able to give a little bit of reaction
MR. TRACY: This is a footnote on the pesticide security
issue. As mentioned, it was addressed at the federal level.
But there is a program -- a pilot program -- in California.
It's into its fifth year. A real crime task force, where the
state has been funding the local sheriff's department, and
they in turn work with agriculture through Fax Net and E-mail
Net. It's been extremely successful in disseminating information
on suspects and pinpointing where thefts are going on. That's
the good news. The bad news is that the State of California
had an energy crisis last year and we spent way over budget.
And so this program is in real jeopardy, and so we will be
looking for other funding sources to get a very good and viable
program, not only for pesticide securities. But just in general,
being out in a rural area when you have an $80,000 to $300,000
tractor part there, and you're just waiting on the good graces
and honesty of the people around there. It doesn't take long
to snap one up and then head it south across the border pretty
So we are looking for additional funding sources and if anybody
can help us in that direction. Maybe the Homeland Security
might be one direction to look.
MS. MULKEY: All right. Well, let me give you just a
little bit of general feedback about what we're struggling
with to try to make this committee work for you and for us.
The work group model, where you have multiple ongoing, pretty
high level of effort meetings and produce a work product,
is available to us, and I think we can select over time a
pretty small number of projects. And quite frankly, there
is a fairly high level of transaction costs in that model.
Now, there are some payoff that comes from that transaction
cost in terms of people working out their differences, or
at least reaching a higher level of understanding about their
differences and some of those kinds of things, and the potential
for some more sustained alliances and collaborations and so
forth that go beyond the mere dialogue, if you will. And then
there is the just come around and everybody says their piece
with their card up and go away model.
What we're trying to do is struggle to find something between
those two that works for you and works for us for most topics.
And we can opt for the work group model on some topics, and
we can opt for the once around and done model on some topics.
And we are -- last time, as you will remember, we had used
the work group model for inert disclosure, and what has resulted
is a very thoroughly worked through set of issues, which then
comes to us much more prechewed than it otherwise would have,
but not, I might note, preresolved. There is the risk assessment,
which is essentially informational and we're trying to keep
you updated, but there doesn't seem to be a lot of energy
around them. You need to have the group keep working it. You
just want information over time, for now anyway. There is
the EUPs. That was largely informational. There was anthrax.
That was public health pesticides. Maybe a little more than
that, which is why you had a little more robust update about
information, and if we get to a critical stage, we might go
further than that.
Today's topics so far, my take on e-commerce is that maybe
some of you will begin to want to put together some kind of
network among yourselves on this. But that's not gelling yet
and there is not a lot of energy behind wanting to do that.
Electronic data submission. We hope we've motivated and informed.
That doesn't seem to lend itself. Biopesticides, on the other
hand, I sense some interest in some kind of continuity of
work together. Sharing ideas. Building ideas. Maybe even developing
some alliances to work some issues. Helping each other and
helping us and advising us. But I don't sense that you want
a multiple meeting work group on that. And so the challenge
there is to find a way for us to keep that going, whether
it's the chat room or whether it's you guys taking the initiative,
to form, you know, sort of off line some connections and so
forth. That is all by way of reacting to the ideas you've
now presented us with. Let's start with the pest management
strategic plans. The only reason I would see why we wouldn't
give that at least the level of attention that we did for
biopesticides, which is to put together some of you who have
knowledge of it. Have you do some work ahead of time. Have
you provide something meaty and meaningful to the rest of
us, including our part of it, and then see where we go from
The only reason I can think of not to do at least that much
is the question of whether that overlaps too much with what
we hope will soon be an active transition work group of CARAT.
So subject to checking that out and making sure that we're
comfortable with consistency across the table, that seems
to lend itself to this model that we're using, which is put
people together to work on it. Have them do some homework.
Have them do some work here and see where it goes from there.
It's interesting, pesticides and security. We floated it as
a topic for this meeting, and the only feedback we got was
please, no. And we got that from a small subset, admittedly,
and everybody else was silent. So I think there is some question
about whether there is a broad enough sense that this is the
forum, but certainly it's open to update in a minute kind
of thinking. And if we had gotten anything other than please,
no, to it, we probably would have included it in updates in
a minute. We do have some information we could share.
The Data Quality Act. Probably update in more than a minute,
but unclear yet in my mind whether that is something that
a lot of people have a stake in and an opportunity to discuss.
But we'll definitely keep it on our list. Overall how companies
do R&D and what the implications are for the future pipeline.
I think we've only heard now one or two people mention. Let's
see if that gains some momentum. That seems to have some potential.
Inerts methodology, we have continuity. So that leaves out
of all the ones registration review. Carolyn before she left
sent word she was into ecological risk assessments, but nobody
else has spoken to that, both of which gathered some interest.
Allergenicity. But all with sort of one or two -- so we need
to look into it. Is this more an update in a minute or a short
informational presentation kind of question. Leaving us with
the one that there seems to be a lot of energy around for
now, which is some scope tackling of the alternative testing.
I think the question for us to think about is, how to launch
into that, and at a minimum, I think, we would like to put
the most interested folks from the committee together to do
some homework in anticipation of the next meeting on that.
Now, whether that means convening an actual work group, it
feels to me a little premature to think about that, because
the question is just what is the scope. What is appropriate
for this committee as opposed to -- some of this is just science
questions. You know, how to validate these tests, or what
kind of information is necessary. So I think we are receptive
to working that one in a more interactive way. Those are just
immediate feedback. We'll listen more. We'll hear you more.
I just wanted to give you a little bit of what I'm hearing.
What initial thinking. The whole point in this electronic
forum is to allow these ideas to bounce between you, so that
we don't -- aren't limited to just this dialogue.
That's how I process what I heard on behalf of the agency.
My views are not the only ones of the agency that mattered.
In particular, the ones where there is a heavy USDA role,
such as pesticide strategic plans, we very much, you know,
look around to see how they think this kind of forum fits.
But those are some short term reactions, which apparently
prompted some thoughts on your part. So, Lori?
MS.BERGER: Forgive me if I'm wrong. But were activity
based REIs part of your list?
MS. MULKEY: I'm sorry. I missed that. And I heard it,
and I heard it twice.
MR. BALLING: Three times, actually.
MS.BERGER: And I honestly think if Shelley was here,
she probably would have chimed in on that.
MS. MULKEY: Right. No, you're right. Yeah. I think
that lends itself quite well to at a minimum sort of a full
informational dialogue. We could at least explain what we
think we're doing and why we think we're doing it, and maybe
we could have a panel to talk about what are the implications
in the field. I know we've had some discussion. We've actually
had some pretty robust discussions with California about this,
because it raised some real issues in their minds about enforceability
and other issues. So, yes. No, I'm sorry.
MS.BERGER: That's okay.
MS. MULKEY: I'm working too fast.
MR. BALLING: Let's get California here on that.
MS. MULKEY: Yes, right. That's the point.
MR. BALLING: If Toby is the one that wants to fight
that, let her come in with all of us, too.
MS. MULKEY: Well, that's sort of what we're trying
to do here. And as you noticed, there were some folks here
who you wouldn't otherwise have seen. Because what we tried
to do was plan these topics in a way that we had really valuable
resources here on a topic.
MR. BALLING: Great.
MS. MULKEY: And not just our own people or the members.
MR. BALLING: Great.
MS. MULKEY: So, yes, I think we would want to include
California if we were to discuss that topic. Larry?
MR. ELWORTH: One of the reasons that I feel participating
in this committee is valuable is also to be of use to the
agency. So one of the things that I would hope you folks would
feel free to do is to give us feedback on the kind of information
that we were able to provide back to you whether it's any
use in the program at all, and maybe things that this committee
can do, either in terms of issues or in terms of participation,
that would make our time here more valuable to use. I would
just encourage you to look at things like --
MR. ELWORTH: -- and get back to us.
MS. MULKEY: You said that before, and actually we --
we're trying to accomplish that while we accomplish making
you feel productive. I mean, it really is about our needs.
And that's why this issue about biopesticides adoption --
actually, I think the idea of doing that originated with us,
and it's because we're struggling with the question of what
role should we play. How does it fit. And the work that was
done to prepare, as well as the work that went on today, I
can tell you right now was and is of considerable value to
us. And so I think we are finding -- and in some ways that's
vastly more an efficient way for us to gain the value than
a full blown work group that would -- you know, really eats
up a lot of our effort as well as yours. Julie?
MS. SPAGNOLI: This is in reply to, I think, Larry,
you know, wanting to know more about the process maybe for
development of products. I think, you know, that could be
something that could just be a short presentation. I don't
think we would get into, you know, the full details. But maybe
it would be useful --
MS. MULKEY: And tell us all your trade secrets?
MS. SPAGNOLI: No, we wouldn't tell. But I -- you know,
I think -- and I'm not even here to speak to -- you know,
I don't know that our process specifically -- I think it's
very -- probably very typical. I would say probably all the
companies have, you know, a similar type. And it might --
I think it might be useful just to get an understanding of,
you know, I think, some of the issues of why is it important
to know when you're going to get a registration and those
kind of issues, and how a decision is made to, you know, choose
to develop a product and what goes into that.
And I think it could probably be, you know, done in a fairly
short presentation. Just kind of an overview of the decision
process and the development time lines. And I think it could
probably help everyone have a better understanding of it from
that -- from the product development point.
MS. MULKEY: Well, one of the things we're learning
as we work in this committee is that putting you to work in
doing presentations -- and this offer from Proctor & Gamble
and other industry participants on their experience with alternative
testing, for example, is an excellent example that we can
gain -- all of us can gain by having the talking heads come
from a variety of places. And we worked very hard for today
and tomorrow to maximize that. And we've had some in the past.
Do you remember the time we brought in ORD and had this talk
about all their research?
MR. ELWORTH: uh-huh.
MS. MULKEY: I think we're looking for more opportunities
to make this less about -- just about what we in OPP have
MR. ELWORTH: Yeah. And actually what Julie said I would
support. I was really surprised -- and I'm not easily surprised
-- about pesticide issues. But I was really surprised at what
the companies do in that kind of discovery. It was pretty
MS. MULKEY: I think that the R&D part of the pesticide
industry is fascinating, and I'm sure drug would be, too,
if I had had the opportunity to learn that. I remember when
I first learned about it in the early '80's. I thought it
was fascinating, and I still think so.
All right. Well -- so this is not -- it wasn't meant to be
a conclusion. You know, we're going to look into these issues
beyond this. We're going to use our electronic forum. But
I wanted to give you some sense of our reaction so you didn't
feel like you just spoke into empty air.
Well, Margie, could you help us understand what the story
is on the cash bar? Is it just for us, or is it just -- we
can all use it, if we want to?
MS. FERENBACH: That is correct. It's Hoyas. It's right
-- if you got out to the main hallway and make a left, you
see it. It says Hoyas. It is a pretty big bar, but we have
to share it with the students. And tonight -- Thursday night
I think is student bartender night, so we had better get there
MS. MULKEY: But anyway, it is an opportunity for some
social time. And then we will meet in the morning at 9:00,
and we'll be able to break by one, maybe even a little earlier
if we don't have any public comments again tomorrow. And think
about, you know, how to make this more workable. I'm feeling
very good about the process we're making, but if you're not,
we need to hear that.
(Whereupon, the meeting was adjourned.)
May 10, 2002
MS. MULKEY: -- really comprehensive discussion about
our budget, because the President's budget is presented to
the Congress. The Congress often has a different point of
view than the President's budget. It's part of the Executive
Branch. Our role is always to advocate the President's budget.
And so the kind of dialogue that I think Jay had in mind about
the range of issues relating to our funding is awkward for
us. But I think if Jay wanted to give a report of the industry's
perspective on the budget issues relating to this, there would
be no reason why he couldn't do that in this forum. So --
and I did see him this morning.
MALE SPEAKER: He's here.
FEMALE SPEAKER: He's here.
MS. MULKEY: So what we can do, is at that point if
he would like to do a little five minute update on industry's
take on what's going on with regard to the budget, that is
I will also ask Joe Merenda -- good morning, Joe, just to
say hi to you -- when he goes over the registration resources
issue to just give the barest outline of the status of the
maintenance fee issue, the registration fee issue and the
tolerance free rule issue. Just the barest outline. And so
that's the way we can deal with that issue.
I wanted to take a minute this morning to say a special thanks
to Margie Ferenbach, who is not only our Designated Federal
Official and who makes sure we play by the Federal Advisory
Committee Act rules, but who leads the team. Who does all
the work to plan and execute a meeting like this, everything
from the meeting arrangements to the paper distribution to
Is Margie in the room?
MALE SPEAKER: Yes, she is.
MS. MULKEY: All right.
MALE SPEAKER: Speech. Speech.
MS. MULKEY: I also wanted to take a minute to mention
the electronic forum that our Information Resources and Services
Division -- whose Director, Lin, you met yesterday -- has
worked so hard to make viable, and invite you to also feedback
on that towards the end of the session when we do the rap
up to see what your feeling is about that as a tool. I see
it as making advisory -- bringing advisory committees a little
more into the electronic age. And we actually worked quite
a lot with our Office of General Counsel to be sure that that
system also plays by the FACA rules so that we could make
it meaningful. So that -- that's also part and parcel of what
I wanted to acknowledge.
I will tell you what's being distributed. Then I have one
more remark and then we'll go into the program. What's being
distributed is a new FR notice that we expect to publish shortly.
It was signed either yesterday or today. Those of you who
have been involved in the CARAT will recognize it as the first
of what we said would be tolerance reassessments under a theory
of early noncontributors to the cumulative risk. So it's the
first group of the OP tolerances that are not revoked, but
are deemed by us to be reassessed. It covers 275 of the approximately
1,050, give or take -- at one time I thought it was 1066,
but it turns out that's not the exact number. So it covers
275 of over a thousand OP tolerances. So you can read that
at your leisure. And it demonstrates our belief that it is
possible to reassess certain of the OP tolerances prior to
completion of risk -- a final cumulative risk assessment and
risk management. But it is based on consideration of cumulative
risk as well as the individual chemical risk. So you can have
that. And finally, but definitely not least, I wanted to on
behalf of all of us and the committee thank Adam Sharp and
Burleson Smith for the time they spent with us yesterday and
for coming back and hanging out with us again today. I think
it means a lot to the committee and its members, as well as
to us, the career leadership in the program, to have their
advice and availability, and to offer both of them a chance
to say a quick hello to you before we plunge into the agenda.
MR. SHARP: All I heard was there were good discussions
yesterday afternoon. I'm looking forward to hearing a little
more about some of the things that got discussed yesterday,
and especially this morning on the Section 18's. I guess this
is the -- this is something I mentioned yesterday, and it
is a very important program, of course. And I'm looking forward
to hearing the discussion on the Section 18's, because I guess
in my former life I know how important the Section 18 process
is for all those involved. And all those involved being all
those around the table and many, many folks across the country
who depend on it. So I look forward to definitely hearing
your remarks and taking a lot of notes. You'll see me scribbling
a lot of notes. I'm a notetaker. I love to listen to what
people have to say, more so than -- more so than always giving
my opinion. So in that note, you'll see me taking a lot of
those notes and bouncing ideas back off of you during breaks
and everything else. So I look forward to working with you
on this process. Thanks. Burleson?
MR. SMITH: I was going to say I really don't have any
comments to make, other than I certainly found a lot of very
spirited discussion yesterday. I appreciated that. I'm sorry
that I missed the follow on to the biopesticide area, but
I look forward to hearing more about it. The one thing I would
like to say is I would be happy to make myself available,
since I was not around yesterday during the follow up, to
listen to any perspective you may have. I'm certainly interested
in hearing more individually, and I hope to get the chance
to talk with more of you during some of the break sessions
MS. MULKEY: Thank you. And, Jay, you can catch up on
what I said about the funding.
MR. VROOM: I heard.
MS. MULKEY: Okay, good.
MR. VROOM: Three times.
MS. MULKEY: All right, great. Very good. Well, let's
move then into the Section 18 reform. And Pete Caulkins is
going to be our segment Chair and work us through this session.
MR. CAULKINS: Thanks, Marcia. For the next hour
and 15 minutes we're going to talk about the Section 18 proposed
reform. There are three of them. My panel members are Rob
Forrest, who is Chief of the Minor Use, Inerts & Emergency
Response Branch in the Registration Division. To my right,
I have Dave Widawsky. He's Chief of the Economic Analysis
Branch in the Biological & Economic Effects Analysis Division.
To his right is Robin Rosenbaum. She is from the Michigan
Department of Agriculture. She's the Program Manager for their
Pesticide Registration Program, and she also chairs the AAPCO
work group on Section 18 reforms. She will be representing
sort of state perspectives on this. Bill Tracy is here as
a cotton and carrot farmer in Butingwell, California. He will
be representing the growers perspective. And Adam Goldberg
here is going to be -- from the Consumers Union will be representing
the public interest perspective on this. The format is going
to be, we're going to walk through some of the most recent
trends in the Section 18 program -- Rob will be doing that
-- and walk through the three proposed reforms. Then I'll
go to my panel members for comments, and then we'll open it
for comments and questions from all of you. Rob?
MR. FORREST: Thanks. There are three proposed reforms
that we're going to be discussing today. The first is renewable
exemptions. Second is exemptions for resistance management.
And the third is defining economic loss. And before I get
into the specifics, I first want to, as Pete said, go over
some of the trends that have occurred in the Section 18 program
over the last six years, as well as I would like to give you
some background information explaining why we're talking about
these three particular reforms. When we're dealing with the
Section 18 program, I think a good place to start is to discuss
volume. This graph depicts the receipts that we have had on
a yearly basis for the last six years. Nineteen ninety seven
was the first year of impact, I should say, coming from FQPA.
Before FQPA our average receipts were about 400 to 450. After
'97 they went up substantially. In '98 and '99 they hit about
600, and in 2000 they did start to decrease. Last year we
ended up with about 540.
Another way to indicate volume is to talk about chemical/crop
combinations. To give you an example of a chemical/crop combination,
you might think about Spinosad on peas, for instance, and
the multiple requests that we get for Spinosad on peas turn
out to be the number of 18's for that particular year. Before
FQPA our chemical/ crop combinations averaged about 160, and
you can see the receipts were much higher, obviously. In '98
and '99, they hit about 220. Since '99 they have again started
to decrease. We're up to about 190.
Section 18's that are granted. Although the trend does appear
that we're increasing as the years go by, the percent of 18's
that we grant each year remains pretty constant at about 80
to 85 percent. Denials. The percentage also has been pretty
constant. About 2 to 5 percent of our receipts are actually
denied. The majority of the denials are due to lack of emergencies.
There is maybe 1 percent that we deny because we can't make
the safety findings, and that was true also before FQPA.
This is a comparison of receipts and turnaround time. The
time that we get the application and issue a decision. Historically
our turnaround time, we've always shot for 50 days, and we've
always felt that that was an effective time frame for us to
do the assessment that we need to do and get a response back
to the grower, whether that's a positive or a negative response.
In 1996, the year before FQPA, we had a 53 day turnaround
time. It was one of our best. That started to increase by
2000-2001. We got down to 34 days. The number of crises. I
wanted to put this chart in because before FQPA, we averaged
about 60. There is a good definition of crisis in the background
material that you have. After FQPA -- '97, '98 and '99 --
our crises went up to about 125 a year, and there was a lot
of criticism from external groups that they did go so high.
And we took that very seriously. We worked very closely with
the states. And in 2001 our crises was down to 59.
Just some findings that we have observed in 2001. The minor
use program, 52 percent of Section 18's went to minor use
crops. That's about 300 Section 18's that went to minor use
crops. Twenty-two percent of the 18's were for conventional
reduced risk chemicals, and 56 exemptions were eliminated
for FY-02 growing season, primarily due to new uses and most
of those new uses were minor use crops. This is a chart that
depicts new uses versus the Section 18's that we received.
There is a logic in the assumption that if new use registrations
increase, then there must be a decrease in Section 18 receipts.
And in 1995 and '96, where our new uses were about the same,
the receipts were in the range that we would have expected,
400 to 450. However, in 2001 our new uses went up to 204,
and our receipts were still relatively high, higher than we
would like them to be. So from this chart, I think at least
right now it's hard to make a correlation between new uses
and how many Section 18's we might eliminate that particular
year. So it appears that there is some progress. There has
been a decrease in our turnaround time, there has been a decrease
in crisis exemptions, and there has been a decrease in the
number of FY-02 Section 18's due to new use registrations.
And again, these were mostly minor use registrations.
So with such progress, why reform? Well, a couple of reasons.
Back in 1995 there was a government wide effort to streamline
regulations and EPA began to evaluate the Section 18 process.
Also around the same time, we received a resolution from NASDA
and AAPCO, NASDA being the National Association of State Departments
of Agriculture and AAPCO is the Association of American Pesticide
Control Officials. We received a letter from them. Their resolution
is outlined in the background material. They supplied eight
reforms that they would have liked -- that they wanted us
to consider. Aside from these two being the obvious in terms
of moving us forward, in terms of reforms I would say that
because of the nature of Section 18's, we need to respond
quickly and, again, either positively or negatively. And we're
always looking for ways to improve the process and to expedite
decisions, and that was one of the ways that we got a response
time down to 44 and 34 days.
With the letter from NASDA and AAPCO, we decided that in November
of '96 we were going to hold a two day workshop to discuss
the reforms and to solicit comments. The workshop was widely
attended. It was very much of a diverse group. State lead
agencies were represented, environmental public interest groups,
pesticide companies and academia. The reforms back in '96
were put on the back burner for a while. Three months before
the workshop, in August, FQPA was enacted, and this certainly
changed the dynamic of the workshop in that we spent at least
50 percent of our time discussing the impacts of FQPA on the
Section 18 program. And it was clear at the end of that workshop
that the attendees thought at least at that time that it would
be best for us to focus on addressing the FQPA issues, which
we did. Having said that, we tried to keep the reforms somewhat
in the public eye. In 1999 we put out a proposed rule setting
tolerances for Section 18's, and in that rule we also solicited
comments. We asked for comments on the NASDA/AAPCO recommendations.
In 2001 we began to refocus on the reforms. The states did
as well. AAPCO formed a task force. We met with the task force
back in August to discuss the feasibility of all eight of
the reforms, and at the conclusion of the meeting, these were
the reforms that there was a consensus on in terms of going
So the first reform is renewable exemptions. EPA authorizes
a Section 18 by no longer than one year, and quarantine exemptions
are for three years. This proposal is that if certain criteria
are met, the agency would allow states to recertify an emergency
situation up to two years following an initial authorization.
Why are we doing this? Well, approximately 70 percent of our
Section 18's are repeats, and given the high level of repeats,
we feel that this approach would help conserve some resources.
Certainly the state resources.
And how would it work? The first year the request would come
in and we would do an assessment. Assuming that it's a renewable
exemption, the assessment would be based on risk, which it
always is -- dietary -- because we need to set a tolerance,
ecological, environmental and occupational. We also have to
determine progress towards registration. We also have to validate
the emergency. And since this would be a renewable exemption,
we would have to determine whether the emergency met certain
criteria for a renewable exemption.
Possible criteria. The pest has developed resistance to alternatives
and that's been documented. Alternative products aren't available
due to cancellation. It might be a new pest. Documented loss
of efficacy of registered alternatives. The key to these particular
alternatives is, I think, predictability in that there is
probably a good chance that these requests would last. The
emergency would persist for two to three years. When would
a renewable exemption be unlikely? A new crop. Weather related
pest outbreak. That's not to say that someone wouldn't get
a Section 18 because they had a lot of rain, but there is
not a lot of predictability that they're going to have rain
the next year. Poorly documented emergency situation. Sporadic
pest outbreak. Again, there is not a lot of predictability
there. Or where the alternative product is unavailable due
to a supply shortage.
How would this process unfold? EPA would do their assessment,
and at the end of their assessment if we conclude that this
would be acceptable and we grant the exemption, this would
be, again, a renewable exemption and it would be a one year
exemption that could be renewed for two subsequent years pending
EPA's review and approval of the state's confirmation that
the emergency still persists. Again, the states would be required
to recertify the emergency to EPA each subsequent year after
the initial authorization. In terms of quality controls, recertification
of the emergency would prompt the agency to reevaluate the
situation each year. If any changes in the status of the exemption
occur, if we receive new information, the agency would have
to determine how that new information would impact the continued
use of the exemption. We would notify the state. Let them
know what the changes are and how those changes might impact
Another quality control measure would be that if EPA receives
new information at any point during the renewable exemption.
We would inform the states that recertification is no longer
an option. If, for instance, in year two the state recertifies
the emergency, we approve it and six months later we have
new information that impacts the exemption, and the state
still wants to consider that use prior to the next growing
season, they would have to then submit an application and
inform the agency how our particular argument is -- makes
sense to them or not and how they would rebut our arguments.
So that's renewable exemptions. Next is exemptions for resistance
management. Currently, the agency's position is that Section
18's may only be authorized for resistance management in cases
where documented pest resistance to the registered alternative
has already developed and is expected to result in significant
economic losses. The proposed reform is that if certain criteria
are met, we would allow the issuance of an emergency exemption
for an alternative to be used in conjunction with the registered
pesticide, again where there is documented scientific evidence
that resistance has developed to the currently registered
pesticide, even though the degree of resistance may not have
resulted in significant economic loss.
And how would these reforms work? As I mentioned, we would
grant the exemption for the alternative in cases where there
is documented evidence that shows that resistance is happening
to the currently registered pesticide. Now, having said that,
criteria would need to be established to provide guidance
as to when a requested alternative could be granted under
a Section 18 for reasons of resistance management. One example
might be that the requested pesticide must be of a different
chemical class, or a different mode of action from the currently
registered pesticide. Specific criteria would need to be developed.
We're in the process of doing that. Certainly, any ideas that
you might have regarding criteria to resistance management
would be most welcome.
MR. CAULKINS: Thanks, Rob. Now, Dave Widawsky
is going to briefly explain the proposed reform on defining
MR. WIDAWSKY: Thanks. Thanks, Pete. Well, the first
question that we ask ourselves, and reasonably you ought to
ask us, too, is why do the criteria need revision for determining
significant economic loss. And I'm going to introduce three
ideas about our reasons why we want to consider revising the
criteria for determining significant economic loss.
The first one is the point that Rob made earlier, that the
states have asked us to please think about are there ways
to reduce the data burden that we currently have that is required
in order to make our determination. Some of the states believe
that the data that we're requiring can be onerous and can
take a fair amount of time to collect, and we've been asked
to reflect on whether we can responsibly make our determination
of significant economic loss with less data. The second reason
to consider revising the current criteria is a systematic
difference in agricultural production systems that may lead
to what we might call an unlevel playing field in some cases.
And I'll talk about that when we talk about the limitations
of the current criteria. And a third reason is that if we
can actually make our reasonable determination and be responsible
with less resources from the states, it's also going to require
the agency to spend less resources on analyzing this data,
so it would be a win/win situation for everybody involved.
So what I'm going to do, is I'm going to quickly recapitulate
what are the current criteria for determining significant
economic losses and what are some of the limitations of those
criteria in relation to what I've just mentioned, and then
talk about what we would like to propose for new data requirements,
new methods for determining significant economic loss, and
what some of the implications of this tiered system of data
The current system for determining significant economic loss
is based on normal or observed historical patterns of crop
variations. What we've been asking for is for historical data.
Five years of data on the production of that crop, the prices
associated with that and the cost of production. And what
we do with that is try to determine -- we make a determination
of what the profit would -- the normal profit -- the historical
pattern of profits would be.
When we look at the base line, we compare that base line to
what the emergency situation would be in terms of potential
losses and yield, and in addition to losses and yield, potential
changes in quality from a particular pest or insect disease
or weed. And then how the -- in addition to the potential
revenue impacts, what cost impacts would arise from changes
in pesticide costs, pesticide application costs, potential
changes in operating costs from making different -- using
different equipment, or making additional applications, or
changes in harvesting costs. And then we estimate the level
of profits and what the difference in profits would be. If
the impact of the emergency situation leads to profits that
are outside that five year pattern that we have observed from
the historical data, then we make a determination of significant
economic loss. This has worked for us reasonably well, but
there are some limitations to this method for determining
significant economic loss.
The first is that, as most agricultural producers can attest,
the profits don't fluctuate the same for all crops. My background
is in agricultural production economics. And there is a lot
of data to suggest that rain fed crops have -- because of
the dependence on -- it depends on the rainfall in a given
year, have profits that fluctuate much more widely -- or I
shouldn't say widely. But much more substantially than crops
that have a more controlled water control system like irrigated
crops. And so the result of that is that the pattern of historical
variation is going to be wider for rain fed crops and require
the emergency situation to lead to a profit loss that is greater
in order to fall outside that pattern of historical variation.
And we've been asked to consider whether that is something
that we want to reform or consider revising our criteria in
order to take that into account. The second limitation is
that the historical data may be affected by the emergency
condition if we're relying on historical data and we have
a Section 18 situation that has been occurring year to year.
Over time we start to see impacts on profits and costs and
pesticide use that is incorporating the Section 18 exemption,
and it becomes more difficult to separate out the emergency
condition from the base line condition when we're relying
on historical data.
And third, the historical data may not be available for minor
crops for five years in a lot of states. Those data can be
hard to come by, and when we can get them, they're not always
as well documented as we would like them to be. So what are
we proposing? We're proposing to go to a tiered system of
data requirements for determining significant economic loss.
And the idea is that we would start off at a lower tier with
a smaller data burden, and then depending on the findings
at any given tier, increase the data requirements as we go
-- if we can't make the determination at a lower tier. The
first tier that we call tier one is yield based, and it's
based on the presumption that if yield losses are high enough,
then you can reasonably make a determination that significant
economic losses are going to occur. If somebody is anticipating
that they're going to lose 50 percent of their revenues, you
don't have to get detailed -- we believe that you don't have
to get detailed information on every pesticide application
to realize that, hey, that's going to be a problem and we're
going to realize significant economic losses.
And so that one of the challenges becomes how do you determine
what the threshold would be, and that's something that we're
working on, and I'll get into that in the case study I'm going
to present next. But I just wanted to introduce that to you
at this point. And what it does, it allows to even a threshold
among crops and so you're not trying to downsize the historical
variation, but we're setting the same threshold for different
kinds of problem systems. In some cases, the economic loss
isn't going to come from yield changes, but it may come from
changes in the quality of the produce -- the fruits and vegetables.
That's often the case for emergency situations. And so in
that case -- in those kind of cases, we would like to be able
to go to a second tier, and that considers economic loss as
a percentage of gross profits.
In that case, we're taking into account the yield loss, but
we're also accounting for price and quality effects on the
changes in pest control costs. And we would compare an economic
loss defined as total revenue plus changes in pest control
costs as a percentage of gross profits, and that allows us
to take those price quality effects into account, and make
a determination with more data than we would need under the
yield based tier, but still a lot less than we would require
under the historical variation method. And then increase in
the data requirements. If we're not finding significant economic
loss in tier one and tier two and the application reports
that there is an economic loss, we can consider a third tier
which would look at economic loss as a percentage of operating
profits. And that's getting us closer to the analysis that
we're doing now in terms of data requirements for the current
year, but it's basing the determination on the base line versus
the current year without necessarily going to a historical
variation method and setting some kind of a threshold or standard
for what that percentage would be to come to a determination
of significant economic loss. So those are our tiers. And
what we did is a case study, taking 89 Section 18's analyses
that we did in the 1998-1999 season, and considering the analysis
that we did under the current criteria, we are reanalyzing
those data under our tiered system to see what would happen
if we -- would we get different answers. Would we -- are we
completely out of kilter here in proposing these.
What we did, is we estimated based on these 89 applications
what would be -- what was the yield loss that was associated
with it and under the current system did it lead to significant
economic loss or not. We did the same calculation for tier
two, economic loss as a percentage of gross profits. And then
also for tier three, economic loss as a percentage of -- gross
profits and then the tier three operating profits. And what
we found was that there was no noticeable difference in the
likelihood of determining significant economic loss. And what
that told us basically is that we could use a lot less data
-- and require the states to provide a lot less data -- and
relieve some of our burden in making the determination and
basically come up with the same likelihood of determining
significant economic loss.
In a substantial number of the cases, about half the cases,
where there was a finding of significant economic loss under
the historical or the current method, yield data alone would
have sufficed to come to that determination, and that suggests
to us that there is a real potential for reducing the burden
to states and the agencies for collecting and analyzing these
data. Now, this was a real quick jog through our proposed
changes for making significant economic loss determinations.
If you want more information, we do have a -- there was a
handout at the front on the proposed methodology, and we'll
get a chance to talk about it more in the discussion section.
MR. CAULKINS: Thanks, Dave. Rob, do you want
to do the next steps?
MR. FORREST: We're going to close with going over some
next steps. What we're going to be doing is issuing a proposed
Federal Register notice for public comment. We hope that that
would happen in the summer of 2002. On an interim basis, we
will be implementing the reforms in the 2003 growing season.
This would provide us an opportunity to gain some experience,
to test what works and what doesn't work. At the same time,
we would be considering public comments, and we're going to
pay very close attention to how these proposed reforms impact
on the Section 18 process. After that, we'll gather up our
experience and we'll report back to this committee and we
will revise accordingly. Okay. Now, I would like to have Robin's
-- one of our panel members -- presentation.
MS. ROSENBAUM: Thank you. As Peter said, I am here
to talk to you about the perspective of the AAPCO Section
18 Task Force, and also the perspective of the sole Section
18 submitter for the State of Michigan, which has particular
impact on this first Section 18 revised procedure recommendation.
I've got a Power Point up there somewhere. Well, I'll get
started. On the renewable Section 18 exemptions, we believe
that EPA should allow states to recertify the emergency situation
for the second or third year based upon the state's confirmation
that the basis for an emergency situation continues to exist.
Most of the Section 18's that we request are due to the fact
that the registered alternatives are no longer efficacious
or not efficacious enough, or perhaps there has been a cancellation
of a key pesticide, and the pesticide that we've requested
under Section 18 is the best in the pipeline, if not the only
product in the pipeline. So it's our feeling that if the product
doesn't get registered during the year in which we've asked
for the Section 18, then the urgent situation still exists
in the subsequent year and would therefore warrant another
Section 18 exemption. Another reason why we are supportive
of this revised procedure is that data from the current season
are difficult to obtain early. In Michigan where we have a
single growing season, we harvest into October and oftentimes
it takes, you know, a month or two or three perhaps for the
growers and the Extension specialists to compile the data
necessary to update the Section 18 for the subsequent growing
season. That's not mine. I'm trying not to look at it. Okay.
It just says PPDC, Robin on there. That's okay. There are
only six of them.
So, anyway, what that does is it delays my ability to get
the Section 18 into EPA until perhaps January or February
or March, when I barely speak to anybody else in the office.
All I do is have my head down working on these, and this year,
18 Section 18 exemptions.
So you can see that the timing issue is a problem, that by
the time EPA gets the application -- and I had to put a plug
in for EPA. I mean, they've done great in terms of streamlining
their end of the process and the turnaround has been great.
It's just that we can only get the applications in to them
so early. And this pushes us right up against the growing
season, and oftentimes the situation is that the growers don't
know until the height of the pest occurrence whether or not
they're going to have a Section 18 material. So that creates
some obvious difficulties for the grower. If we could get
the -- if we could certify the Section -- recertify that the
emergency situation continues to exist and give the growers
an extension of heads up earlier, we would have a lot more
time for the growers to strategize their spray schedules for
the summer, and there would be a lot more time for product
stewardship. Our Extension specialists are out all -- you
know, in their winter meetings all year, and they've sort
of got their hands tied when they can't talk about whether
or not the Section 18 products will be available in the subsequent
So if we could recertify in Michigan, for example, in December
-- or even January -- that they're going to have the product
in the upcoming growing season, then clearly that creates
a much better situation, and particularly when you're talking
about resistance management and development of a resistance
And the obvious one, better utilization of resources for the
growers, the Extension specialists, the state lead agency
and EPA. I think it would give us more time to focus on the
initial applications and do perhaps a better job of putting
those applications together. But we're continually being asked
to do more with less and less and obviously need to prioritize
our tasks. Michigan -- or the Governor just announced an early
out package and told us that those of us who are left standing
for the next 20 years can only rehire one in four positions.
So we just lost 16 people. We get four back. That just tells
you what our work environment is like.
And last but not least, on this one, of course EPA retains
its authority to rescind or deny the emergency exemption for
cause should additions to its risk database warrant such a
decision. So there is always that fail safe. So we really
feel that this is a win/win revised procedure recommendation.
Resistance management. We feel EPA should support Section
18 exemptions for resistance management where there is documented
scientific evidence of resistance to currently registered
pesticides or valid research demonstrates the dynamic process
of resistance is developing. As you know, resistance management
is the process of prolonging the useful life of a pest control
tool by delaying the selection of pest populations that are
resistant to it. Resistance management programs are seen philosophically
in the context of integrated pest management, where in IPM
programs pests are held below economic injury levels by utilizing
optimum combination of strategies which offer the most minimal
adverse effects. To require growers to use up all of their
effective pest management tools before the situation is considered
an emergency as defined by Section 18 regulations seems to
not be in accordance with IPM.
The future success of resistance management depends upon the
continued availability of a diverse arsenal of efficacious
pest management tools. The benefits of this would extend to
the consuming public and to the environment as a whole through
the increased availability of wholesome produce at affordable
prices and reduced pesticide load to the land, water and air.
And I have to throw in the Colorado potato beetle example
in talking about reduced chemical load in the environment.
Several years ago I put together Section 18's for use of a
few products for the Colorado potato beetle. And in going
through that process, we surveyed the Michigan potato growers
and asked them to submit a list of the chemicals they were
using to try and control this pest.
I mean, it was pretty incredible what they were doing. Basically,
we saw the word cocktail on their spray list many, many times,
that they were taking several insecticides and throwing them
in the spray tank and hopefully some combination of those
sprays were going to kill this persistent pest. So we eventually
obtained the Section 18 exemption for Metaclopred and, you
know, hugely reduced the pesticide load on the environment.
So while it's unrealistic to expect the emergency exemption
process alone to provide the solution to the pest resistance
problem, we feel that its judicious use in a proactive manner
could offer a significant contribution to the resistance management
effort. And lastly, significant economic loss. We feel that
EPA should support the use of yield loss and/or other economic
indicators instead of or in addition to the five year production
cost averages for crops with a high variability. And I won't
spend a lot of time on this one, since David did us such a
nice job of laying it out.
But most of our Section 18 exemptions are for use on minor
crops. Seventeen of the 18 I processed this year for Michigan
alone were minor crops. Current agency guidance says that
loss is significant only if it exceeds the normal variation
of profits over a five year time frame. States and growers
feel that this practice discriminations against minor use
crops with high variability, because a much higher loss is
required to fall outside of the normal range and it doesn't
take into account a number of factors outside the control
of the grower, which cause fluctuation in profits and losses
and mask the emergency nature of the situation. An example
of a situation that wouldn't fit the classic economic scenario
is powdery mildew on watermelons. It is a serious late season
disease, where the disease defoliates the vines exposing the
melons to sunburn. Sun exposure turns the melons pale, almost
white, resulting in a poor quality product. The yield numbers
don't reflect the loss, because the grower can still harvest
the sunburned melon crap. The powdery mildew stunts the plants
and the melons, so the grower will feel the losses in the
grade. Grower pack outs are the best way to analyze crap loss.
The pack outs reveal the fluctuation crap grade as a result
of the disease pressure. So basically that's it. Thank you.
MR. CAULKINS: Thank you, Robin. I'm going to
ask Adam Goldberg from Consumers Union now to provide us with
a public interest group perspective.
MR. GOLDBERG: Thank you. On the renewable exemptions,
we certainly don't want EPA or the states to be wasting any
resources. However, to us this proposal seems to be more about
making it easier to get Section 18's that may or may not be
warranted. It is one thing to streamline the process, but
not if it takes the emphasis away from the real reason behind
the Section 18 program. Our problem is that the whole idea
of Section 18's is that they are for unpredictable, unusual
and nonrecurring pest management emergencies. If the agency
is asked to grant a two or three year Section 18 because of
solid evidence showing that an emergency will exist for the
next two or three years, the pest problem justifying the Section
18 seems well outside the definition of an unpredictable emergency.
If the goal of this current Section 18 reform process is to
develop a new category of temporary limited registrations,
let's be honest and up front about it and retain the Section
18 program as is, since it clearly does serve a vital, although
too pliable, purpose. If there is a continuing need for a
particular pesticide to be used on a particular crop year
after year, then there is no longer an emergency use and the
resources should be put into getting a permanent tolerance
or registration in place. In fact, if the goal is efficient
use of resources, why not speed up permanent registration
for reduced risk, low exposure products and uses. If you look
at the numbers that were presented, there are far too many
Section 18's granted and the numbers seem to be going up every
year. And there are very, very few denials, and while the
denial numbers are higher in 2001 than in 1996, it's not an
appreciable difference really. It's a very small number of
the overall numbers of submissions. Basically from our perspective,
the Section 18 process has gotten too routine and that's really
a problem. EPA should tighten up the Section 18 process. Figure
out a way to speed up reduced risk registrations and get on
with some other pressing business.
On the resistance management exemptions, we think that this
proposal makes more sense than the renewable exemptions. The
agency has registered a few dozen very promising effective
reduced risk and biopesticide products in the last five or
so years, yet many are highly vulnerable to resistance problems
because of their specific mode of action. It is a good idea,
indeed essential for EPA to pull out the stops in an effort
to head off resistance problems to key active ingredients.
The Section 18 program can play an important, albeit a limited
role in achieving this goal. Section 18's in the name of resistance
management should only be approved by the agency, however,
when there is solid evidence showing that both registrants
and growers are doing everything they can through other means
to responsibly manage resistance. Accordingly, if EPA accepts
resistance management as a criterion for approval of Section
18's, the applicant should be required to document that all
other recommended proven resistance management strategies
are being used to the full extent possible, and that still
resistant populations are growing more common and/or levels
of resistance are growing. In addition, explicit and strict
resistance management language should be incorporated onto
the labels approved covering resistance management driven
Section 18's. Plus, the label should specify acceptable rotations
of active ingredients as well as unacceptable rotations.
Finally, the significant economic loss proposal. This one
is really problematic and always has been, I guess, and I
think it always will be. History shows over and over that
farmers seem to find a way to innovate around the sky is falling
syndrome. I think part of the reason that they do, is in reality
there are far more pest management alternatives than advocates
of Section 18's might want to admit to. Plus, really serious
major losses are typically associated with rather unique and
limited combinations of soil types, agronomic systems, plant
genetics and pest management systems.
In talking to a couple of my colleagues about this particular
proposal, one of them pointed out that there are a lot of
people who are knowledgeable observers of what's going on,
including Bob Holm, who call this the golden era of pest management.
And I think that that's true. We think that too many Section
18's in the past have been justified by a need to bail out
farmers who have made mistakes in their pest management systems,
and we would strongly oppose granting Section 18's for any
pesticides other than reduced risk and biopesticides if the
major justification is the breakdown of an irresponsible,
full throttle pesticide treadmill based pest management system.
That's a lot to get out there. We would like to see EPA reward
a commitment to IPM and penalize sloppy and disruptive levels
of reliance on conventional pesticides. That would obviously
address some of the problems that we're seeing, not only with
economic loss, but in general. And we appreciate the fact
that we're here before the PPDC discussing this, but I think
we also have to discuss what kind of -- how we define acceptable
alternatives when we're judging the economic impacts. And
I think that's a general comment as well about how we should
be proceeding on Section 18's. So I guess my overall comment
is that we feel that there are far too many Section 18's granted
in general. This is an emergency use situation and it should
really be treated that way.
MR. CAULKINS: Adam, thank you very much. I will
now turn it over to Bill Tracy to give us the growers perspective
on those reforms.
MR. TRACY: Thank you, Pete. When Pete called and asked
me to be on this panel, he said you have five minutes. And
out west, a farmer can hardly say howdy in five minutes.
MR. TRACY: So I'm going to have some prepared comments
here, because my mind tends to wander like a leppy calf in
a herd of cattle if I don't keep everything focused. Incidentally,
in California we have 281 commercial commodities in California
and only half a dozen of those are major crops, so Section
18's are extremely important. A good farmer is known to have
down field vision. We're constantly working with the vagaries
of nature and we're planning ahead toward a multitude of variables,
and that helps us decrease the changes of getting caught with
a surprise and an unhappy banker at the end of the season.
In many instances when our fields are invaded and the conditions
are perfect for the pest, a crop can be lost within an extremely
short period of time. Renewable exemptions would allow for
a down field vision of a planned emergency approach for a
Section 18 application submitted. All the paperwork is reviewed
much in advance of the possible need. It would allow for an
orderly review without the rush of emergency and for proper
planning by industry if a problem develops. It would avoid
untimely and damaging delays of going through the application,
review and approval process for an emergency before an emergency
has been established. This seems best for all sides and it
has worked well in California. It has been suggested and makes
a lot of sense to issue multi-year approvals upon completion
of the original complete review, and approval of second and
third years would be left up to the respective state's review
for renewal. They are the closest to the previous use patterns
and problems, and if there is a need to renew, why duplicate
the same process and same review each year at the state and
On resistance management criteria, establishing significant
economic loss is time consuming to prove, especially in an
emergency situation. Sometimes five year data is impossible
to obtain, especially on new minor crops. Resistance management
criterion points the issue in the right direction. It has
to be a written plan. It stresses the introduction of reduced
risk products. It limits the use of old products by seasonality
and in some cases the number of applications in a year. It
stresses introduction of new chemistries and new modes of
The overall goal is to maintain efficacy of whatever product
is used with the hopes of not developing resistance by alternating
use of different chemistries and modes of action. This would
put more tools in the farmer's resistance management toolbox.
Allowing this approach for qualifying for Section 18 would
encourage the implementation of resistance management programs
that in many cases are just being looked at in some areas
today. Our California program has been effective and very
beneficial to our industry and has served us well in working
with government agencies. On a sidebar to that, I think allowance
of reduced risk products to be introduced as a Section 18
certainly has merit, since they receive favorable treatment
in today's review and release processes.
Establishing a new calculation for significant economic loss.
Money should not always be the determining factor in economic
analysis because of marketing schemes and/or market and price
fluctuations. Also, yield losses must be weighed with an analysis,
and is probably just as an important factor as the bottom
line dollars. But don't forget. You can have a good price
and a good yield, but if quality suffers -- as in my industry's
case, sticky cotton -- or production costs soar -- such as
pest control -- you will lose on the bottom line. And five
years of data sometimes is impossible to provide. In conclusion,
with a loss of use associated with FQPA, Section 18's become
increasingly important. The Section 18 process has served
the industry well by allowing the introduction of new chemistries
and modes of action to address emergency situations prior
to certain products receiving final registration. This process
does not dilute the necessity and important review process,
but gives opportunity for further review in real life but
controlled settings. Unknown and unaddressed problems are
sometimes realized in the process and are able to be corrected
and/or addressed before final labels are issued and widespread
use is initiated.
Now, just as a little aside and as a member of the regulated
community, I'm going to ask the committee's indulgence to
share with our regulators a little insight from the field.
Farmers by nature have an aversion to paperwork. We view it
as taking time away from our fields, and that is where a whole
lot of conflict and misunderstanding comes from the regulated
community and the regulators. Filling out paperwork either
takes time away from our fields or something that must be
done after dark and after work. Simply stated, we have a dirt
oriented community regulated by paper oriented agencies. In
my view, mandatory regulation would be much more palpable
without mandatory paperwork. I'm going to share with you a
form letter our family farm sends out. We receive about eight
to 10 solicitations for surveys a week in the mail. This is
one paragraph that comes from there.
It says we are drown in required county, state and federal
forms, surveys, reports, records, notifications, postings,
filings, permits, certificates, fees, descriptions, licenses,
registrations, inventories, audits, meetings, classes, returns,
validations, amendments, inspections, responses, handbooks,
pamphlets, warnings, appeals and a slew of others that don't
come to mind right now. It is getting difficult to find time
to break away from the office to do real work. Thank you very
MR. CAULKINS: Thanks, Bill. By my watch, we
have about 25 minutes for questions or comments.
DR. LOCKWOOD: I'm concerned by what I think I'm hearing
as an excessive focus on the bottom line being dollars. I
was at a speech last week where one of the speakers said money
is only money. As a physician, I think that health based criteria
ought to be essential in the determination of whether a Section
18 exemption ought to be granted. And I heard only the most
oblique reference to anything that had to do with health in
MALE SPEAKER: I thought it was an excellent panel presentation.
Thank you. It was really very illuminating, and I liked a
lot of the ideas. One of the points that Adam made, that I
thought was very good, of course, was looking at reduced risk
and biopesticides. Naturally, I think that's a great idea.
The other thing from my perspective, Robin, and your counterparts
in the other states, one of the problems we are finding in
the biopesticide industry is that we're not being looked at
as the alternatives that are already registered products.
And that has been typical. We see these coming through occasionally,
and we're starting to see them after the fact. And we try
to maybe do something for next year, too, but we find that
the states don't always look at viable alternatives that are
already registered. And I think it's incumbent on the states
and the U.S. EPA to look at products that are already registered,
and particularly the biopesticides.
MS. POPOWITZ: Sorry. It usually takes so much longer
to get to me. I want to comment on -- sort of pull together
a few of what I thought were really pertinent comments that
went around the table and make a point from my perspective,
which is the public health perspective.
We're very much supportive of the Section 18's. I understand
emergencies. I understand farmers. I understand bugs and funguses.
And clearly that's not an argument, I think, around this table
that the importance of having those are required. Furthermore,
as Robin pointed out, it is part of the appropriate integrated
pest management system to respond to emergencies. Taking that
point, though, and really integrating it into the conversation,
it also goes against what -- I can't even quote Adam's sentence.
But it had like a lot of chemicals used on the field chronically.
And chronic low level constant chemical assault of the soil
is not a long term solution, but it is the way farming is
done for the most part.
We are having a huge problem right now that everybody is completely
aware of, which is antibiotic use on farms, and this is chronic
low level, constant in the feed and in the animal antibiotic
usage. The antibiotics that have been preserved in the medical
environment as our hard hitting, silver bullet, never used
unless the guy is half dead type things, are being used in
agriculture chronically and constantly. And they're surveying
workers that work with these animals, and they're finding
that they have some of these low level resistance organisms
to what we consider the silver bullet biomedical solutions
with antibiotics. Chemicals are no different. And so when
you're using chemicals at chronic low levels constantly, that's
not -- you're -- that's not in tune with what you're referring
to as an integrated pest management need for a Section 18.
So we're not asking for both. It's not fair to say we need
Section 18's because this is part of integrated pest management,
but we also need to constantly assault the soil with chemicals.It
is not going to work in the long term. That's why we have
so much pest resistance, and that's why we have soil plums,
and that's why we have soil blowing around and burnt out soil
and all sorts of other problems and health problems. So really
understanding the importance of Section 18 needs to be disjointed
from this repeat registration year after year after year which
no longer constitutes an emergency, but actually constitutes
a way of life and we need to deal with that separately.
Also, I want to stress the importance of considering as alternatives,
as Robin and some other people did, but to, again, integrate
that into practice to consider --
(End of Tape 4, Side A.)
MS. POPOWITZ: -- so that emergencies can be responded
to and that people can sleep well at night. Not just the farmers,
but all the rest of us that live around them and eat the food.
MR. CAULKINS: Likewise. Dan?
MR. BOTTS: One quick question, first. On your survey
or your case study of the threshold studies, will more than
just a summary of that document be available? Because I would
like to look at it just from the context of the Section 18's
that we're involved in on the cost analysis that is there
relative to crop site pest combinations don't always fit into,
as Robin pointed out in the watermelon example, the model.
The economic models that you're talking about. I would like
to see the universe of actual Section 18 petitions that went
into that survey, if I could, just to look -- get a crop site
MALE SPEAKER: You would like to get a list of all the
crop site combinations?
MR. BOTTS: Yeah, that went into the survey and if any
of them were petitions that we had submitted. And I would
like to ask a question of the people sitting around this table
right now. I know Robin deals with Section 18's. How many
other people in this room have actually written and submitted
Section 18 petitions to the agency for approval? A point I
would like to make. We do about the same number that Robin
does through our association. We are the petitioning organization
for the specialty crop industry to the state lead agency in
Florida. The issue that Jennifer brought up on discussion
of alternatives, we've not submitted a petition since 1982
or '83 that didn't address every registered alternative or
potential production practice associated with control of that
pest. We produce our petition. It goes through a state review
process. It usually takes a tremendous amount of time before
it ever gets to the federal level where all of those issues
are scrutinized and looked at.
I'm fully supportive of the reforms that are proposed in this
thing, but I think there is a misconception about what is
currently in Section 18 petitions and an understanding of
what you have to look at from a public health standpoint.
Those factors are reviewed not only by EPA, but at least in
the case of Florida, and I know in the case of California,
at the state level extremely extensively before those petitions
ever go forward. I think that's one of the reasons why the
denial rate is a little bit lower. And the ones that we've
had kicked back for one reason or another have not been because
of the review process that was done prior to getting to the
agency. It was things that came to life after the petition
had been submitted that led to issues around a particular
crop pest combination.
So I would suggest that the direction you're headed is a great
first step. I would also go back to the '96 workshop and pull
out a lot of the other recommendations that came out of that
stakeholder group involvement, that included more than AAPCO
and the state lead agencies and putting forward a proposal,
including public interest groups and other people, and look
at some of those other options to pilot as well.
MR. CAULKINS: Thank you.
MS. SPAGNOLI: I'm speaking from the manufacturer's
perspective. On one thing, I guess, I will agree with Adam.
We, of course, support, you know, faster review and registration.
However, in the situation with emergencies, oftentimes the
data necessary to support the registration needs to be generated
in response to that emergency. The glassy wing sharpshooter
being one of the examples where a new pest, you know, erupted.
There was an emergency situation and data needed to be generated
to support a Section 3 registration. So you know you're going
to have that emergency situation continue, so while that data
can be generated and reviewed, that emergency will continue
Also from a manufacturer's perspective, we only produce a
chemical that we're going to sell. You generally plan to only
-- you know, nobody keeps excess inventories of chemicals.
We only are going to buy raw materials and produce as much
chemical as we plan to, you know, use that next season. So
from that perspective, to have a more predictable process
for being able to supply the growers would obviously be an
advantage to manufacturers in their production planning. If
there was a renewal process that they could then know that
-- predict what quantities were going to be needed for a particular
crop or pest for that next year, it would definitely make
sure that we could provide the growers with the amount of
chemical they were going to need.
MR. CAULKINS: Lori?
MS. HARDER: From a tribal perspective, we deal with
Section 18 issue on the Tribal Pesticide Program Council,
and some tribes are -- would like to use Section 18 because
they do have production agriculture and other tribes do not.
But there is a consensus amongst TPPC members that would support
some kind of Section 18 reform that would be more restrictive,
and a reform that would be for an emergency exemption and
not for an emerging trend.
And as somebody who does monitoring, a lot of our tribal lands
are at or adjacent to agricultural lands or wherever pesticides
are being used, and I monitor water quality and soil and air
quality and those type of media. And it gets really hard,
because for a lot of new chemicals that are being used that
are registered -- they've gone through the registration process
-- there aren't laboratories that can analyze the media to
see if it is in the environment. And so for Section 18's that
aren't registered, I'm going to assume that there won't be
any analytical methods for those in laboratories. So how does
this really ensure environmental quality? You know, that there
is no harm to the environment or that there is no persistence,
and how can I take that back to the people and let them know
MR. CAULKINS: Larry?
MR. ELWORTH: Are you all going to answer that question?
MR. CAULKINS: It's answered.
MR. ELWORTH: Well, actually one of the things I did
want to mention that didn't come up when Alan raised his concern
that the agency does a review of the environmental and health
impacts of these Section 18's before you grant them. It's
not just -- there are criteria that you follow besides economic
in determining whether you're going to grant an 18 or not.
Secondly, I do think one of the things Robin said made a great
deal of sense. It doesn't make a whole lot of -- it makes
a lot of sense to not wait until nothing works to decide to
take some action. I think that's a smart way, both from an
integrated pest management and from a regulatory point of
view, to look at this alternative -- using the alternatives
for resistance management. I wasn't quite clear, and maybe
this isn't the right time to mention it. How are you going
to explain the data requirements for the economic loss provisions?
Would someone know beforehand which of the tiers they were
applying for and would there be criteria guiding people for
using tier or another? And you can decide if this isn't the
place to describe that, but I would be interested in knowing
that. It might be helpful.
MALE SPEAKER: We will make the criteria available and
transparent, and if you want to talk about the details, during
the break I'll be happy to.
MR. ELWORTH: Sure. Sure. Also, this FR notice? What
is the nature of this FR notice? Is this
-- does the agency believe that this -- this requires rulemaking?
Are you making a proposed change to guidelines? What is the
FEMALE SPEAKER: As we're currently envisioning
them right now, it would really just be a Federal Register
notice describing the -- actually a lot of what you heard
the EPA panel talk about this morning. Probably filtering
in, I think, a lot of the different comments that you're making.
But it wouldn't actually be a rulemaking.
MS. MULKEY: We believe it can be done under the existing
MS. BRICKEY: Well, I have some comments, but I first
wanted to ask a couple of questions. What is the agency's
policy now about allowing a Section 18 for a pesticide that
is not registered? No Section 3.
MS. MULKEY: You mean no Section 3 for the active ingredient?
MS. BRICKEY: Right.
MS. MULKEY: Or no Section 3 for that use?
MS. BRICKEY: No Section 3.
MS. MULKEY: Rob?
MR. FORREST: Are you talking about a new chemical?
MS. BRICKEY: Uh-huh. I hope so.
MR. FORREST: Okay. As far as a new chemical is concerned,
we have had Section 18's on new chemicals. But we have only
had Section 18's on new chemicals when we've had enough data
to make the assessment that we need to make.
MS. BRICKEY: Meaning you've been able to grant a tolerance?
MR. FORREST: We have granted temporary limited tolerances,
MS. BRICKEY: And how many of those have there been,
MR. FORREST: Very few. Certainly, maybe a handful,
if that. If that.
MS. BRICKEY: And what about if you canceled a use on
a particular crop. Have you granted subsequent Section 18's
for that use?
MR. FORREST: For a different chemical?
MS. BRICKEY: No.
MR. FORREST: No.
MS. BRICKEY: For the same chemical. Let's say you have
a pesticide. You cancel certain uses for a variety of reasons.
MR. FORREST: Right.
MS. BRICKEY: But not all uses.
MR. FORREST: Right. Probably -- I don't know off the
top of my head, but certainly we would be suspect to go forward
with an 18 where we canceled uses.
MS. BRICKEY: Do you have a policy on that?
MS. ROSENBAUM: Carolyn, the current regs that provide
the framework for the Section 18 program actually create what
I would call sort of a higher hurdle. If you're talking about
a pesticide for which we've had significant risk concerns,
there is a public notification piece that we go through so
that we actually have to issue a FR notice telling the world
that we have received the request.
And if it were literally for a use that -- if it was the same
use that had been canceled for risk concerns, the actual process
is in fact quite a bit more elaborate. And at least in my
memory, I don't remember receiving a request in such a circumstance
or much less actually granting it. So there is a pretty high
hurdle when you're talking about a chemical where we have
identified significant risk concerns.
MS. BRICKEY: But you don't have a policy that says
you wouldn't grant it?
MS. ROSENBAUM: Well, the basic policy is laid out in
the existing Section 18 regulations, and it's not a flat out
we will never consider it again. But it creates a process
that is designed to provide opportunity for significant external
participation and oversight precisely because there was some
underlying reason for concern about that use.
MS. MULKEY: We couldn't grant it unless it met the
statutory standard. Whatever the relevant standard was.
MS. BRICKEY: My experience in working with this program
is that the feeling about how it is operated has waxed and
waned at least three different times I can think of. The tightening
of the program has been a result of huge numbers of Section
18's, oversight from the Hill, and whatever pressures the
agency has felt to reform the program and make it better.
In this case, which would be a major loosening of the program,
I don't know exactly what the pressure is, except that people
feel that it is hard to provide data, which I'm sure sometime
it is, and they don't like to do paperwork, which I totally
understand because I don't like to do paperwork, either, and
I can hardly figure most of the paperwork I do out. However,
the number of days it takes to get a Section 18 are dramatically
down. The number of crises exemptions are way down. And the
number of denials are way down. So it's sort of hard for me
to understand why we need to undertake a major reform of this
program, given the fact that it seems to be working very well.
And the other concern I have is that this is already a pretty
fluid program, shall we say, and we're adding more and more
-- we're taking some of the rigor we have in it -- assuming
we have rigor -- and we're eliminating it and making it easier
to get Section 18's. So another concern, I guess, that brings
to bear for me is what would be the cost of making these changes?
Would the program be cheaper if you did it this way because
you have -- you're certifying repeat applications? You know,
where is the good government angle on this.
MR FORREST: I don't think that the cost would be so
much EPA's cost. I think it would be more for the states.
MS. BRICKEY: So the program would cost EPA the same,
MR. FORREST: Well, certainly there would be resources
in terms of processing the Section 18's. That would save some
resources for the Registration Division.
MS. BRICKEY: Have you projected those costs?
MR. FORREST: Not exactly, no.
MS. BRICKEY: I was just wondering if maybe we would
save some money that we could apply to new registrations since
we have a backlog there.
MS. MULKEY: It's relatively modest.
MR. FORREST: I don't think that the money -- the cost
that we would be saving in terms of the processing of the
Section 18's would necessarily transfer into review of new
MS. BRICKEY: So I guess my feeling about this is if
we had a fairly rigorous program, I would certainly support
the notion of doing -- certifying renewals. I don't have a
big problem with that, because I think mostly that is a matter
of paperwork. But because we have what is a pretty lax program
now and we're proposing to make it much more lax, I'm just
wondering about the value of this program. You know, I guess
I raised this when you had your workshop in 1996, Jim. I'm
just wondering if we shouldn't just give the states these
18 exemptions when they ask for them and then evaluate what
happened afterward, because I'm not sure that we're going
to be doing a whole lot here to protect the public health,
given the fact that the standards are going to be much lax
-- more lax than they are now.
MR. CAULKINS: Bob?
MR. HOLM: Thank you, Pete. First of all, I want to
compliment the panel for an excellent presentation. I've been
in industry and around for 30 years, and I think that was
the best clearest explanation that I've heard. And also, I
guess, with the being around for a long time, it gives you
a little bit of context.
I would like to remind people that back in the '80's there
was a lot of complaints about Section 18's because they just
seemed to be perpetual. There were Section 18's for eight
or 10 years or so. I think maybe the longest one had run up
to 12 or 15 years, and people were saying well, this is just
a way for market entry early and to avoid the process of getting
the data. I will say that I think this is dramatically changed
right now. It's been noted in kind of a reference in Rob's
presentation, but IR-4 this last year was involved in about
160 of those 400 some Section 18's. So we have a significant
part of the program. We don't initiate the request. Obviously
they come at the request of the state. But when we've got
ongoing programs on those minor crops that we can provide
residue data, you know, we've got a committed program. We're
going to finish the work.
We have a 30 month completion schedule that we've committed
to the grower community and EPA that we're going to get the
work done and complete it. There is a commitment there. So
there are data there. When the state requests them, we immediately
submit the residue data that we have available so that EPA
can make the risk assessments and the dietary risk assessments
in order to judge whether that product is safe or not. I think
what's missing here in some of the discussions -- and Bill,
as a grower, pointed it out. Most of these uses are for minor
crops. And FQPA is very hard -- boring down on taking products
away -- older products -- for minor crop growers. So what
does that leave growers to use? IR-4 has focused exclusively
our program on reduced risk, safer chemistries and biopesticides
to provide FQPA transition. So this is what we're working
for. And to not allow these chemistries into the market, I
think, is not participating in the FQPA transition process.
I think another thing to really consider here is the fact
that a lot of these newer chemistries have very specific modes
of action, and the registrants are restricting their use to
not more than one, or two sometimes, applications a year,
which sets up resistant -- you know, it calls for resistance
management strategies. And many of these minor crops only
have one or two crop protection tools for any particular insect
So if you restrict it to one product and don't allow multiple
products to have different modes of action in order to use
resistance management, you are jeopardizing that new chemistry
within two to three years of developing resistance before
the product, you know, can really be used. So I think the
Section 18 process is working. IR-4 is committed to supporting
it, and we're committed to getting new reduced risk chemistries
on the market that are safer for the environment and for human
MR. CAULKINS: Thank you. Our hour and 15 minutes
is up. I'm going to ask Shelley and Lori and Jay who had their
cards up and that's it.
MS. MULKEY: And John.
MR. CAULKINS: And John.
MS. DAVIS: Thank you. I'm here on this committee today
representing Eric Nicholson, and Eric in particular wanted
to comment on this issue. And so I am presenting his comments.
Eric Nicholson works for the Farmworker Union Pecoon in Oregon,
and so his experience really focuses on Oregon.
From 1993 to 1999 the State of Oregon received 178 Section
18's, at least 10 of which involved approvals of the same
chemical for three or more consecutive years. So we're really
concerned about too much approvals of things that are not
emergencies where the Section 18 begins to look like a round
end of the Section 3 process.
In particular, we would like to raise the example of Encloselin,
which in the late '90's received its 15th consecutive Section
18. So this is not the past history. This is a very current
thing. And Encloselin in particular raises a lot of concerns
for workers, because the evidence suggests that it has an
anti-androgen effect, and so it does pose a significant health
concern. And so in our view, it raised the problem that this
was approved year after year and there was no adequate protections
given on the worker side. And in that perspective, aside from
our general opposition to this renewal process, we would like
to see that when a product is given a Section 18 and there
are risk concerns, that there be added enforcement requirements
to ensure that worker safety really is being protected.
Another thing we are really concerned about is the loosening
of the criteria on economic loss. Because, again, that just
seems to feed the idea that these things should be renewed
year after year. So in a nutshell -- let me just raise one
other thing. I am -- I'm not an eyewitness to this, so I just
want to raise this in response to what Carolyn raised. And
that is that it's my understanding that Vincloselen has now
been subject to an agreement with the registrant to phase
out uses for snap beans in a couple of years from now, and
that when this agreement was reached, the issue got raised,
well, what happens if we still need this as a Section 18 after
the phase out. And this is a phase out, not a cancellation.
But the problem that precipitated the phase out is a health
problem. And it's my understanding that the EPA basically
said that they would entertain a Section 18 at that time.
So it is our view that the Section 18's become an around an
un-registration even when there are health risks.
MR. CAULKINS: John?
JOHN: Thank you. I decided to raise mine back up after
what I heard Bob say. I just wanted to touch on one little
item quickly with respect to resistance management. The current
approach has to do with problems that already exist, and the
way it's proposed to be reformed or the rewrite is what is
developing or happening. And I would just say that perhaps
what you should do is write it so that it's a little more
forward looking, because you know the factors that are likely
to lead to resistance to develop. So that means that you could
predict if it would happen. So, therefore, why not look forward,
because the costs of allowing it to happen are too great.
And, of course, the steps towards resistance management developing
occur before you recognize them -- or before you can recognize
them. Does that make sense? So take a little bit more forward
approach and maybe rewrite that a little bit differently,
so it's looking to the future and looking at our predicted
capabilities with respect to resistance management. Does that
MS.BERGER: Okay. I had a comment and a couple of questions.
First of all, it was brought up by Adam that one of the reasons
Section 18's are needed is because farmers need to be bailed
out because they've made bad pest management decisions. And
I really take exception with that, Adam, because I think that
farmers are some of the best multi taskers that I've ever
seen. And we really do appreciate diversity in germ plasma.
We've made mistakes in the past with disease susceptibility
and that kind of thing. Diversity in germ plasma and diversity
in products -- I can tell you in working at the field level
that when a Section 18 goes through, it is not -- growers
don't really like to have to rely on that system. It is a
pain for a commodity group to have to go through the paperwork
and generate that. And then when a Section 18 is granted --
and I know in California, DPR -- they generally do not submit
a Section 18 package to U.S. EPA unless they are very sure
it's going to go through. So the number -- because we have
so few refusals at the national level, that means that anything
that might have been rejected was most likely done so at the
And when a Section 18 is passed, there is automatically a
reduced -- I mean, excuse me -- a restricted use pesticide.
So that means that there are -- there is extra reporting.
They are subject to monitoring at the time of application
by the local ag commissioners and so forth, and there are
in fact enforcement requirements, whether it's health or whether
it's environment. There might be X number of feet from waterways.
There might be special protective equipment and this type
of thing. So I just would -- for people that are not familiar
at the field level with how a Section 18 comes about, believe
me. Growers would much rather have a product that does not
have these restrictions on it and has a full label. So that
is really what growers want. So I just wanted to make that
comment. And I just had a couple of questions. One, on these
three tiers, is the data all submitted at once in these three
tiers, or do you submit a tier and then come back with another
tier? Is it one time or two times or three times?
MR. WIDAWSKY: The idea is that you would submit the
data once, and whatever is sufficient to make the case is
what you would submit if there's yield data. If you want to
make a case and yield data is not sufficient to make a case,
you think about the second tier. And if you make the determination
before you send it to us, as you say you're screening it before
then, then you may look at the data and analyze and consider
them, and you may want to submit more data that would cover
a tier three analysis. So it would be one submission.
MR. WIDAWSKY: And then whatever data would be appropriate
to make a determination is what we look at.
MS.BERGER: Okay. And then finally one last question.
One of the -- on the slide that talked about when would renewable
exemptions be unlikely, one of the bullet points was that
an alternative product was unavailable due to supply shortages.
And I can see how that's maybe bad planning on the side of
the registrant or the manufacturer. But I can see certain
cases where this would be an emergency for a grower. Why is
the grower being the one kind of punished here for bad projections
on the part of a registrant?
MR. FORREST: What I was saying was that if there is
an alternative that has been registered but that alternative
might not be available, then we can use a Section 18 for another
MS.BERGER: But if it's not available due to a supply
shortage, I mean, it's not available. I mean, so --
MS. MULKEY: He was saying you would use the Section
18 in that year.
MR. FORREST: Right. Right.
MS. MULKEY: But it wouldn't be a good candidate for
a multi year.
MS.BERGER: Oh, okay. Okay.
MS. MULKEY: That was what that slide was about.
MR. CAULKINS: Last comment.
MR. VROOM: It feels to me like there has been a lot
of progress made, and like many who have already spoken, you
know, I feel like a veteran who has had moments when my head
was spinning, maybe even literally as well as figuratively,
when we talked about Section 18's in the past. But I would,
you know, vote on the side of those comments that have already
been made that express appreciation for the progress that
the agency is making. I may have missed it, but I didn't hear
any references to USDA's involvement in this process. I assume
that that's happening and I would encourage that. And I think
in the next section of our discussions here on resources,
it's appropriate for us to talk a little bit more about, you
know, what does Section 18 cost in terms of agency resources
and what can be saved. And Carolyn's point in that area, I
think, is an excellent one that we ought to continue to put
some focus on. The last question is, I recall -- I don't have
a copy of FQPA here with me. But I believe there was a specific
requirement of the agency on Section 18 process related to
FQPA, and I'm not sure that we talked about, you know, specifically,
you know, what those statutory requirements were and the agency's
performance on that. Maybe it has already long ago been done,
but I just can't remember that.
MS. MULKEY: A quick answer to that is, we were required
to set up a process for setting tolerances. We did. We did
it by rule. i think we finalized the rule. And we feel like
we've fully implemented that.
MR. VROOM: And that's all working fine now, right?
MS. MULKEY: Uh-huh.
MR. VROOM: Okay. Sorry.
MALE SPEAKER: Can I clear up a point of information?
MS. MULKEY: Sure.
MALE SPEAKER: Was this proposal -- these three reforms
were a proposal brought by AAPCO, is that right? And so to
the extent there was any pressure, it was brought by the states
for a variety of reasons, is that right?
FEMALE SPEAKER: (Inaudible).
MALE SPEAKER: Okay. Okay.
MS. MULKEY: Well, this -- your interest in this has
presented us with a time management challenge, but in every
other way has been very helpful. The lessen I learned from
this is that there is still an interest in this topic, that
it has not become ho hum despite the maturation of all our
experience in this area. We anticipate that we will go through
a proposal process, as we described. We can factor your input
today into that proposal process, and we'll do so as we heard
it and as it seems appropriate, including in solicitation
of comments as well as in the proposal. One of the lessons
I heard is that we probably have a challenge around transparency
regarding the Section 18 process that we've not fully met,
because I heard some perceptions from multiple sources that
seemed to me not to jive completely with what we understand
to be reality. And so maybe this is also an opportunity for
us to do more to reveal some of the basics and content about
how the process works, and what the criteria are, and what
the circumstances are, and also what our experience is as
it relates, for example, to old chemistry versus new chemistry
or other kinds of issues like that.
So I think we can factor all that in from your input. I want
to also thank the panelists, who I thought were terrific and
gave us this kind of multiple perspective which allowed us
to kick off this very useful dialogue. Now, with respect to
our time management problems, we're going to take our break
now. We really, really must be back at five till. The next
panel has a challenge because of their continued availability,
at least some of the members. So during the break, we're going
to sort through how we manage the next one. We have ample
total time left to us. The challenge is just in what order
we do things. But if we don't sit back down by five minutes
till and not a minute later -- (Whereupon, a brief recess
MS. MULKEY: -- our information may be, or at least
our statement of opinions and positions may be.
The timetable works and Joe has been very gracious to agree
to do his conclusion of the updates in a minute after this
next panel. So, Anne, if you could kick off the next panel.
MS. LINDSAY: Okay. This session we've actually got
two panels. We'll start off with a panel composed of various
different government officials, each of whom had some role
to play in a set of, I think, unfortunate misuse occurrences
from last year. That will include George LaRocca, who is a
product manager in our Registration Division, and actually
as product manager has responsibility for some of the chemicals
that were actually involved. Van Kozak, a little bit to my
farther right, who is one of our regional pesticide managers
located in Dallas. He has actually also been a headquarters
person and a state official, so he's got a fully rounded perspective.
And Phil Benedict, who is in charge of pesticides for the
State of Vermont, and again with one of the episodes that
you'll hear had some direct hands on and involvement. And
then Terry Troxell will complete -- from FDA will complete
the government panel perspective.
After that we would move to sort of a short reaction panel
that will include some reactions from Dan Botts on the grower
perspective, Shelley Davis -- well, Shelley I actually expect
will bring in some other aspects of misuse that we won't have
heard up until that point. And you'll find at your place another
background paper that I think has helped to inform some of
the thoughts that Shelley is going to share with us. So you
may want to take a look at that. And then Jay Vroom, when
he's back, will be the wrap up for the reaction panel. And
then just as we did with the last session, there will be some
opportunity to go around the table and get some insights from
the rest of you. Both for the future, how can we do better
with these misuse incidents, and probably more importantly,
how can we actually work together to prevent the occurrence
of these kinds of events. So with that, I would like to hand
it over --
MS. MULKEY: Just hold on a minute. I was hoping that
before you started -- it's going to be hard for Jay, Dan and
Shelley to react --
MS. LINDSAY: When they're not here?
MS. MULKEY: Yes. So I was hoping that getting this
started would have the salutary effect of at least the three
FEMALE SPEAKER: Here's Shelley. Here comes Jay.
MS. MULKEY: Okay.
FEMALE SPEAKER: Who else do we need?
MALE SPEAKER: Dan.
MS. MULKEY: Dan and Shelley. Oh, there's Shelley. All
right. Well, two out of three is probably okay.
MALE SPEAKER: He has already made up his mind what
he wants to say, anyway. You know Dan.
MS. MULKEY: Yeah, okay. Okay, Anne.
MS. LINDSAY: Okay. So with that, George is going to
start and actually try to give you a fairly succinct overview
of the pattern of misuse cases that we saw last year.
MR. LAROCCA: Thank you. Between May and September of
last year, a number of EPA people, including myself, spent
quite a bit of time on misuse incidents that occurred in several
states throughout the country.
What I would like to do in the next several minutes is just
briefly identify the types of misuse cases so that you have
some idea of the nature and magnitude of the incidents. Then
identify some issues that EPA had to work with with respect
to these misuse cases, list some brief observations on why
this occurred -- at least at this point why we think some
of this occurred -- and just mention briefly some ways perhaps
to prevent misuse in the future. The ones I'm going to identify
now are not all the misuse concerns we had last year, but
they -- the ones that I'm going to mention are ones that did
involve the potential for illegal residues in food and feed
and also involved FDA. Last year state and federal officials
discovered off label and misuse cases in nine states that
involved four pesticides, implicated nearly 300 people, affected
more than 50,000 acres of crops and resulted in a multi million
dollar payback program for wheat. In Mississippi specifically,
there were 47 growers that illegally applied Zadasaccharinmetrum,
which is fury or mustang, to 18,271 acres of wheat to control
Army worms. At that time, fury was not registered for use
on wheat, nor did it have any tolerances in place.
It was alleged that the company representatives and/or crop
consultants may have suggested the use of fury at half the
legal cotton rate, which was a registered rate, for control
of the Army worm and indicated that there would be no detectable
residues found in the wheat. Unfortunately, there were residues
found. In Arkansas there were 17 wheat producers and 16 commercial
aerial applicators who illegally applied fury to 7,387 acres
of wheat to control Army worms. The same situation here again.
Growers alleged that company reps and/or crop consultants
suggested use of this pesticide at half the legal cotton rate.
In Kansas we're dealing with another pesticide -- a herbicide.
There were two wheat fields owned by three persons that were
illegally treated with the herbicide Paraquat prior to harvest.
As a result, the Kansas Department of Health and Environment
embargoed 17 million bushels of wheat. It was alleged that
growers may have illegally used Paraquat as a preharvest use
to avoid heavy dockage fees for weeds and grasses. Paraquat
is a desiccate registered for preemergent use on wheat only.
In Tennessee we go back to another synthetic pyrethroid. Tennessee
had identified at least 74 growers who illegally applied fury
to 14,000 acres of corn, 3,000 acres of soybeans, 60 acres
of violet and 150 acres of Bermuda grass to control Army worms.
Similar to the wheat incident, fury was not registered for
use or had tolerances for any of these crops. Tennessee had
documented that farmers illegally used fury simply because
the product was cheaper than other pesticides with similar
uses. Most used it as a preemergent or prophylactic treatment.
In Louisiana two farmers illegally applied fury to 700 acres
of corn to control Army worms. These farmers applied the product
on corn -- the farmers who applied the product on corn also
were cotton farmers, and apparently they had used fury legally
on cotton and believed that transitioning to use of fury on
corn would not be a violation.
In Vermont we had use of another synthetic pyrethroid, Landisahowatrun,
a warrior. One hundred and twenty two growers illegally applied
warrior and also Chlorpryaphoss Larsban to 5,500 acres of
pastures and 205 acres of small grains. In Vermont it's typical
for a pasture to be comprised of a mixed stand of alfalfa
and grasses, and although in this case both insecticides had
tolerances in alfalfa, neither had tolerances in the grasses
or small grains, thus making an application to a mixed alfalfa
and grass pasture a misuse because of the grass component.
In Connecticut warrior was illegally applied to 800 acres
of hay and pasture land. In this case, growers used this chemical
due to severe Army worm outbreak not seen before in the northeast.
Likewise in New Hampshire, three growers illegally applied
warrior to 68 acres of pasture land and Larsban to 24 acres
of pasture land. The reason being the same, because of the
severe Army worm outbreak. And lastly in Massachusetts, there
were nine growers that illegally applied warrior to 308 acres
of pasture land and Larsban to 80 acres of pasture land. About
10 illegal applications were made by two commercial applicator
companies. Growers again used these chemicals due to a severe
Army worm outbreak. Misuse cases that occurred led to significant
resource demands of EPA staff last year. Because of the incidents,
we needed to quickly coordinate with the states, EPA regions,
EPA enforcement, FDA and USDA to find out the answers to why
Some of the questions that we asked for and the information
we asked for was how the states found out about the misuse.
Why did growers misuse these pesticides. How many growers
and farmers were involved. How many acres of crops were treated.
Status of the harvesting. Time frame for harvesting. What
growers were doing with adulterated crops. Have they planted
under or burned it. Are growers replanting. If so, what were
their rotational crops. Has the adulterated crop been removed
or moved off the farms or grower premises. Any information
on commingling issues with untreated food or feed. Status
of state investigations. What actions are states pursuing,
i.e., civil or criminal, and what are the current needs of
the states and/or regions from EPA. Also, results of residue
analyses of adulterated crops. These misuse incidents did
cause serious economic and financial disruption for hundreds
of growers last year whose crops became suspect and involved
in some cases in quarantine. In addition, states had issued
notices of warning, suspended applicator certifications and
assessed fines and penalties.
In looking back at this cases for possible reasons for misuse,
we did come up with certain observations. Number one, there
appeared to be known misuse occurring too frequently. Two,
most misuse occurred due to high pest pressure. Prophylactic
misuse in anticipation of a severe pest infestation. The misuse
product of choice was cheaper. Grower at harvest desperation.
Misinformation. Lack of knowledge of tolerances. In other
words, use on cotton equals use on corn. Lack of clarity in
some cases on pesticide labeling. Types of crops that can
be treated. An example would be pasture and the mixed stand
of alfalfa and grasses. And last, company reps and consultants
encouraging misuse. These are just some general observations
we made, and we plan to utilize these observations in the
future for developing plans and recommendations to prevent
misuse. But we did learn from our experiences with these misuse
incidents that an ounce of prevention is worth a pound of
It is real important for us to get out to the growers. What
we call grower outreach and education. Make them more aware
of what's out there, what's available and alternative pesticides
early on if pest pressure is going to occur that season. Make
them more aware of the Section 18 process. Also make them
aware of the reduced risk chemicals. Emphasis requirement
and importance of using pesticides on approved label sites.
Also, identify consequences of misusing pesticides. We need
better coordination among federal and state agencies, and
at this time, we plan to develop a procedure to ensure that
when a misuse does occur, we can react quickly in gathering
appropriate data and convening the appropriate staff to deal
with the misuse. Thank you.
MS. LINDSAY: Okay. Thanks, George. I think that was
actually a very good and rapid overview. Van, would you like
to pick it from the field perspective?
MR. KOZAK: Yeah. Thanks, Anne. I'm going to spend just
a couple minutes sharing an EPA regional perspective on this
pesticide misuse issue. We'll be focusing on the major misuse
kinds of incidents involving the food supplies, since we were
lucky enough to be involved in the fury episode last year
in Arkansas. That was quite an episode, indeed, with as much
wheat as was tied up and looking at possible destruction and
so on because of tolerance problems. The regional offices
-- my section in particular is responsible for all the pesticide
activities in Region 6, which is Texas and all the adjoining
states. And I won't go into much in the way of what we do,
except we're very involved in cases like this. Enforcement
cases that the states take. You are probably aware that virtually
all the activities in the real world are carried out by the
state agencies -- the state lead agencies -- actually operating
under state pesticide law, and we work very cooperatively
and extensively with them.
So what we have come up with is at least some thoughts that
reflect what has happened. And this isn't the only misuse
incident that we've been involved in. For starts, some of
the contributing factors that we have encountered, of course,
the first one is economics. Obviously, everybody knows that
are extremely tight profit margins in agriculture. In the
last 20 years, I haven't heard anyone say to me that things
are good in agriculture economically. That's one thing I haven't
heard. I was reminded yesterday of a joke or an old story.
The country doctor who came to a woman after she gave birth
to her son and said, ma'am, your son is going to be a farmer.
And she asked, well, how can you possibly know that, and he
said, well, he was born crying. And so it seems to fit at
least the mood in agriculture that we encounter some of the
time. In any case, another issue which is obviously on everyone's
mind is the loss of pesticide products to cancellation. FQPA
and other reasons have tightened up the arsenal of chemicals
that are readily available to growers, so this puts some pressure
on them as well. panic situations. I mean, I think this applies
in a lot of the situations we encounter, and certainly applies
to some extent, at least so we're told, last year with fury
when the Army worm populations grew rapidly and early. And
so to some extent, it doesn't have to be logical. It just
has to happen in order to be a factor in farmers reaching
for whatever tools they feel are available.
I might add that in addition to economics, there is a certain
amount of attitude in the real world that occasionally crops
up. The business of we probably won't get caught, or there
won't be any residues, or perhaps it won't do any harm because
the registration is pending. These kinds of attitudes, I think,
can contribute to some extent to some of these very bad decisions
that growers make. Another issue that has already been mentioned.
It's a continuing issue. It's confusing and misleading labels
and labeling. There has been a lot of progress made, but there
are still labels out there that could be misinterpreted or
misread in terms of when the use is legal. So that's a common
thread. Another issue that doesn't offer surface, but that's
inappropriate product promotion by university extension and
researchers. We have seen that very clearly in one case several
years ago when it came to our attention that catfish aquaculturists
in Arkansas were using Malathion in their ponds to control
some type of fish disease. I forget which kind of a fluke
it was. And there was no registered use for that product.
We discovered that the source of this particular problem was
a brochure that had been published by federal aquaculture
researchers that showed among many compounds tested, Malathion
was quite effective for this purpose. This was never intended
as a recommendation for its use, which they might quite clear
to us when we visited the facility, but it did cause a great
deal of consternation in the aquaculture industry and could
have caused a serious problem. Additional contributing factors.
The rush to market phenomenon, which may be the reason for
some of what we see as inappropriate product promotion by
company sales representatives. And George mentioned earlier
that fury -- the allegations in Arkansas and elsewhere where
there was a sales representative that was recommending the
product for use. Obviously, it's a tight market. Obviously,
there is a certain amount of pressure for early market entry
and early opportunity for market share among the pesticide
companies. This may be some -- there may be some pressure
for this kind of behavior to occur.
We've seen situations -- our states have seen situations where
brochures have advertised the merits of a compound for use
in a product before the compound receives its registration.
And it may be wonderful information, but it can easily be
used or misinterpreted in terms of encouraging people to use
it prior to its registration. We have stopped imports of unregistered
products as they enter ports in our region because they weren't
registered, and the word that we've received is that the product
was under Section 18. Upon further investigation, the application
hadn't been submitted. So we had a little bit of a premature
motion of material in that regard. We also -- there was a
report earlier that Jack Neylan made in terms of the Internet.
We've also seen incidents of premature advertising, or inappropriate
advertising, with these anthrax products that were originally
registered for use in government buildings under Section 18,
and the advertisements that were out there were attempting
to provide them to the general public. So those are a problem.
Now, enforcement issues also play a role. We have perhaps
an adequate surveillance. Certainly it could be better. Mostly
-- in most of the states, enforcement tends to be driven by
complaints. Far and away the largest number of enforcement
investigations are complaint driven. These kinds of incidents
typically won't come to light unless there is a snitch or
we stumble upon it in one state or another and continue our
So there is not a great deal of intensive oversight over private
applicators and producers as a matter of constraints on resources
in the states. Most of our complaints are driven by commercial
applicators and so on. So this may contribute to some of these
incidents that we've seen. We also have federal and state
authority which is an issue. In many states, FIFRA -- both
the FIFRA authority and state authority really call for warning
letters only for first offenses for producers. Whether that
is a good thing or a bad thing, it's certainly the kinds of
enforcement issues we're faced with when we see these kinds
of incidents as a potential first response. There may be shared
responsibility in these incidents. Farmers may pressure applicators
to apply the product on advice of a consultant, who is ultimately
responsible, and that becomes an issue.
Our willingness to act against producers. What can I say?
States differ. Some have a greater willingness to act. Some
have more authority to act and so on. So this is also an issue
that we felt is worthy of observation.
Now, in terms of prevention, we have come up with a few ideas.
Obviously, some of the simple ones are to improve the labels
and labeling, which the agency is working on all the time.
We can increase or enhance our training of university support
staff to make it clear that research findings that are communicated
to the public can sometimes be misread as an endorsement of
an illegal act, and that they should be very careful when
they are releasing information on the efficacy of a product,
that they also go along and make clear that the user must
check to determine it is legal.
Enhance training of users. We can always enhance training
of our users beyond what we do today. And that certainly is
an area that we could enhance. We could increase the number
of inspections, particularly at the farm and producer level.
We could enhance our EPA/FDA cooperation in pursuit of potential
violators. We have an excellent working relationship with
the Food and Drug Administration in Dallas, but we don't have
a formal process for collaboration on incidents of this type,
or even a highly formalized process for reporting information
back and forth when we see violators. It's ad hoc. So we could
perhaps improve that relationship overall.
We could establish a vigorous and consistent federal and state
enforcement posture. I think that the fury incident probably
led us part way in that direction. AAPCO issued a very vigorous
statement regarding their views on the severity of these incidents
after they had happened. And I think it's incumbent on us
to make sure that our enforcement position is as consistent
as it can be, given different state enforcement programs.
We could change or enhance regulations that relate to advertising
unregistered products. And finally, we could take whatever
action is deemed necessary to discourage or penalize registrant
misconduct in the way that perhaps occurred in the fury incident,
although there have been no cases at this point brought against
anyone with regard to encouraging the misuse.
One point I might mention with regard to regulations. The
State of Arkansas right now is at least considering changes
in regulations to better oversee crop consultants in the state
based on what they have discovered in terms of their role
perhaps in the use of fury in Arkansas.
MS. LINDSAY: Thanks. Dan, I need to do a time check.
DAN: You have time.
MS. LINDSAY: Are you okay? Okay. Let me move on then
to Phil Benedict, who will give you kind of a bird's eye view
from the state level.
MR. BENEDICT: I'm going to walk you through about 20
days in Vermont. On July 3rd I was out doing field visits
-- farm visits -- and my deputy commissioner said we've got
an Army worm outbreak on our farm. I said oh, good, that happens
in Vermont. There is a field or two every year. It's sporadic.
At the end of the day, we stopped and looked at her field,
and she had about two acres of corn that wasn't there anymore.
The rest of the corn was about 12 inches tall and it had been
And I went on vacation at that point for a few days. I came
back on July 9th and found that we were in the middle of a
disaster. On June 6th the staff got a call from the Extension
Service kind of inquiring about what would be legally used
on Army worm in Vermont. So we have Kelly Registration Systems
on all of our registered products, and we searched the databases
and began to deal with those issues. And to be perfectly honest,
the labeling is pretty funky. When you begin to look, it (inaudible).
It's not very clear. And actually the staff had made a decision
that they wanted -- there were two things -- three things
it looked like. One of the products that is still registered
isn't manufactured. I don't think you could probably buy it,
anyway, and that was last year. Kairoll -- it looked like
it came pretty close to being registered or legal on forages.
And Malathion did.
Malathion is pretty clear, but in the old -- I'm too old,
I think, to be in this business. In the old days when you
used to use Malathion, you used to use formulations that were
called M&M. It was Malathion and Methoxychlor. It was
that combination of things that seemed to work. And I don't
think anybody today wants to be in the Malathion and Methoxychlor
business, and I'm not sure a lot of people want to be in just
the Malathion business for a lot of reasons. But anyway, on
the 9th we posted the Army worm fact sheet on the web page.
We included Kairoll. The same day the Extension Service called
and said there is no Kairoll around. Well, Vermont is up north,
and we're at the end of a pipeline on everything. And we spray
late in the season, don't forget. Everybody else had had Army
worm before we had it. So we began to talk about what we ought
to be doing. So we called the agency about doing a crisis
exemption. Chatted with the agency for a day or so on what
we wanted to use and what they wanted about what was appropriate,
and actually on the 10th decided that we would go for a crisis
confirm. Did the paperwork on the 10th. The agency was great.
Through this whole episode, the agency was great. It only
gets worse. That's the problem.
Did the crisis on confirm. Actually had that out on the 11th.
Got it back on the 11th. I think that's a fairly decent turnaround
time, personally. We had that on Channel 3 news on the 12th,
so that covers 80 percent of the state. By the way, also on
the 9th Jim Leland sent an e-mail to all of the inspectors
to begin to take a look, because we're hearing these kind
of rumors about things going on out there. On the 13th in
the morning, I got a call from a Mail Cooperative. They had
a farmer who had a herd of cows that got into the neighbor's
field. A herd of cows. And that was not -- at this time, we
didn't know this. They were in there for less than an hour.
But we got that a little bit later. That field had been sprayed
with the warrior. It was a mixed stand, so sent somebody out
to collect -- actually Jim Leland went out and we collected
milk samples. The milk had been picked up in the evening,
so we had two days storage on that farm for milk, so we had
two days before we had to dump any milk.
Collected the milk sample on the 13th, which was the morning
one. Collected one on the 14th. Ran both of those samples.
Didn't find anything in the milk. Began to talk with Syngenta
about what we ought to find. How long it would take if it
was in the milk to show. All of those kinds of issues. Looked
at the tolerance. Took 10 percent of the tolerance and tested
on that. And felt pretty comfortable after talking with everybody
that we were probably all right, especially when we found
out the cows got in and they were there less than an hour
and then they were taken back out. On the 16th, called --
started calling the applicator community -- we're small --
and reminding them that warrior probably wasn't a legal use.
It was legal on corn, and it's legal on pure alfalfa. But
I was particularly concerned, because we were seeing quite
a lot of spraying going on on grasses that were surrounding
corn fields to protect the corn. On the 17th, told the agents
we wanted everybody's records. About 2:00 that afternoon,
I figured this wasn't going to go fast enough, so we called
the applicator community and invited them in on the 19th of
July and told them to bring their records. And they all showed.
They were all there at 8:30 in the morning with their records.
We had seven out of 10 companies that had used either warrior
or Larsban and there were 123 farmers or so involved.
What we really wanted was names and addresses at that point,
because we -- with forage crops, if you're harvesting it as
hailage, we're in second cut, which means we've already got
one cut in the silo or in the bunker silo, and we've got material
going in. As we looked at the records, the first spraying
occurred on 6/30. The last spraying occurred on 7/20. So this
incident all occurred over just a few days. We were talking
with the agency at this point quite a lot trying to figure
out what we were going to do. So on the 20th, we sent 123
farmers a letter saying, hey, you have been treated by a commercial
applicator. The application was not legal. You should separate
your crop if you're harvesting it. If you've harvested it
and you've got it in the bunker silo, you need to identify
the area it's in. We're not sure you're ever going to be able
to feed it. Those letters went out. That created quite a few
At that same point, we were collecting forage samples and
running those in the lab to figure out what levels we had
in the forages. We wanted to know what we had. You know, we
had corn tolerances. We had alfalfa tolerances. What did these
-- what did this stuff look like. And by the way, in Vermont
we're 80 to 90 percent Gary, and all of this stuff is grown
on the farm for feed. It's not sold. And the commodity that
is sold is milk or meat and there were tolerances for these
products in those commodities, but there isn't anything in
EPA had a conference call on the 23rd with the states to figure
out what was going on in neighboring states. I had been talking
with some of the neighbors. We supplied forage results on
the 26th. On the 27th, we got approval to send a letter out
to the growers, telling them how they could feed it and what
they had to do with the forages.
Just some summary information about Vermont. A little bit.
We had seven applicators involved. We had one applicator that
made one illegal application, and we had one that made 56.
So the span was all over the place. Again, we had between
five and 6,000 acres involved in this incident. Some of it
was alfalfa. Some of it was corn. Some of it was corn and
grass. We had two applicators working on some farms sometimes,
so it got real fascinating trying to separate out who did
We decided to send out administrative penalties. By the way,
we looked at farmer records, too. We had a farmer buy some
in May, but he had had it the year before in his corn and
actually that got returned. And that was purchased on the
25th of May. So we didn't have -- we don't have many dairy
farmers do their own treating. In some ways, I think we're
lucky. We can work with the commercial applicator community
to solve some of these problems in other ways, when you get
in trouble real fast because you don't have much backup. We
sent out penalties that ranged from $1,000 to $56,000. Did
that about the first of January. It was the first week of
January, and I think we had hearings in the House Ag Committee
in the second week in January. There was a lot of concern
about these poor farmers and these applicators that we're
going to put them all out of business, and the Commissioner
assured them that we weren't, but we wanted to get some people's
We're still in the process of resolving these cases. We'll
settle some of them outright and some will be settled with
assurances of discontinuance.
I guess the message I've got, is I don't think from a state
perspective we've done a very good job explaining to people
how tolerances work. And because the argument that came back
to us was you could spray it on strawberries and eat it tomorrow.
You know, you can spray it on this and eat it tomorrow. You
can put it 15 times on that. You know, what was wrong. And
people don't understand that there are data needs before you
do those things. You've got to show that you're not going
to create problems. I really think that's a weakness in our
program, in Vermont at least right now, but I think we'll
get through it. We've uncovered some other things. I believe
that alfalfa in forages --
(End of Tape 4, Side B.)
MR. BENEDICT: -- an awful lot of labels out there that
I don't think are understood. When I started this, I actually
called three chemical companies and asked them what their
label meant. They all had alfalfa on it. Basically, they all
had the same statement. I got three different responses. And
I -- and by the way, we've got recommendations in the northeast
today that talk about planting mixed stands and have these
products in them to treat them. So if we have this kind of
thing in the educational community, and we've got the agency
saying these applications are clearly illegal on these mixed
stands, we've got some real problems and they are structural
problems that we've got to solve. So I guess the solution
is to figure out what -- how do we get products that can be
legally used, and we need to go through the processes to get
them registered if the chemical companies are willing to do
that and move on. And I guess that's it.
MS. LINDSAY: Okay. Dan, I think maybe you need to go
next. So, Terry, if you'll just wait a second. We'll get a
reaction and then we'll come back to you.
MR. BOTTS: I would like to first of all thank Anne
for allowing me to go ahead and go, because I've got a 12:00
that I've got to be downtown for, and I really appreciate
I think what you've heard is a microcosm of all the issues
that are out there relative to potential misuse issues and
the trends. I can only thank God that there was not a Florida
example in any that they worked at or presented here today.
That's not to say that there aren't examples that could have
been done from a Florida perspective.
I would like to put just a little bit from the user's side
on the table. How we've attempted to deal with the concept
of misuse as an organization for our membership. And I would
suggest that for fresh fruits and vegetables, which is who
I represent, the penalties tend to be a little harsher in
some respects than they do for wheat, corn and some of the
things that you can store and hold until the tolerances reach
a nondetectable level or below the level of quantification
which would allow them to go into the channels of commerce.
Essentially what happens with a misuse of the tolerance violation
for our industry is that crop is destroyed and you lose every
bit of the value that you have in it. There is no recourse.
So the administrative fines and the penalties above that are
almost immaterial if you have just walked away from your whole
crop. So there is a real incentive in our membership's industry
not to make a misuse.
Having said that, the same economic factors, the same panic
factors, the same other issues that come in there with a pest
outbreak, or issues where they are seeing their crops go down
the tubes because of a pest that they can't control, leads
people to take drastic action. And I won't kid you and tell
you I haven't had a phone call from a grower saying what am
I supposed to do. I'm going to lose my crop if I don't use
this product. And my response is, that product is not registered.
It's not labeled on this crop. You are subject to misuse citations
and fines if you use that product. Thank you very much and
hang up the phone.
Now, I don't turn around and pick up the phone and call DAX
and tell DAX that I just had a call from XYZ grower, because
I don't feel that that is my role as a trade association.
We do have a policy in our association that was passed on
a unanimous vote by both my functional committee, by the Board
of Directors and by the general membership on misuse.
And it not only deals with misuse. It also deals with education
to prevent the possibility of misuse, so that the membership
has an understanding of what the requirements really are,
which I think is a major failure in all of our roles in this
process. The certification and training and public outreach
associated with understanding exactly what is involved in
misuse and labels and the whole process there. We also in
that policy took a very strong statement for very rigorous,
equitable, evenhanded enforcement where actions are taken
when a misuse has been done, and acknowledged in this that
we would not support any of our members if they knowingly
misused a product and were cited for it. If there are technical
violations or issues where things come up similar to what
Phil was talking about, where you pick up the phone and call
a registrant and say I've got XYZ crop, I want to use this
crop product on it, and they get a statement either from a
university researcher or somebody else saying in their opinion
it's legal to use, like the mixed stand alfalfa and grass
issue, which I agree there is label clarification that needs
to take place as well, we'll defend those uses.
We'll defend and go in and work with those growers to at least
bring the issue to the attention and hopefully resolve it
down the road. We're in the middle of dealing with some issues
similar to that right now on some products in Florida. So
we will work on those. But if it's an intentional misuse,
we stand right behind the enforcement folks in the State of
Florida and say do whatever it takes and do it even handedly.
But we can't afford as an industry to have misuse occur because
of the product mix and the integrity of our product stream,
and what any individual does affects every other grower of
the fresh market products that we grow. Inappropriate promotion
by university extension research. I wouldn't necessarily call
it inappropriate promotion. There is a fine line between educational
opportunities and actually going out there and promoting a
product. If we don't have the ability to go out there and
have university and research people provide us information
on efficacy and how to use products, even before they are
registered -- hopefully before they're registered -- so that
we can when it is registered be able to appropriately use
that product, you've cut one big leg out of the implementation
of pest management programs.
So there is a fine line there, and I would encourage as you
try to deal with that, that you look at it very carefully
before you take a sledge hammer approach to something that
maybe needs a carpet tack hammer. Labeling issues I brought
up. I made this statement publicly a thousand times, so I'll
make it again. If I wanted to go to work for Jack Neylan or
the state in DAX, I could probably cite every one of my members
for a misuse based on the labels that are out there for any
pesticide use that is made in the State of Florida. There
is something on that label that I could cite them for. And
there is a real problem in labeling language and inconsistencies
in labels and interpretations. I will stand right here and
volunteer at any point to work with whoever wants to put a
task force together to put these things in English, where
everybody can understand what the directions mean and know
exactly what is doable and not doable. And with that, I'll
turn it over -- back to the panel.
MS. LINDSAY: Thank you, Dan. Now, to finish up the
government panel, Terry, I think you were going to give us
a bit of -- quickly the FDA perspective?
MR. TROXELL: Yes, thank you. Well, during these situations
we had people from centers -- that is, the Center for Food
Safety and Applied Nutrition, the Center for Vet Medicine
-- at the agency level, the headquarters agency as well as
the districts involved. So we had a lot of resources involved
in these various situations. I'm not going to go into detail
in any of these situations. But I think I want to kind of
basically give you our responsibilities, and I guess our viewpoint
or perspective approach. The context where we come from is
the Food, Drug and Cosmetic Act. It places responsibility
for production of safe, wholesome and properly labeled foods
on the producers at all points in the farm to table continuum.
Violations of the Act fall generally to categories of adulteration
and misbranding. Then as we move over into well, what about
these situations, well, the FDA, acting under the FD&C
Act, enforces pesticide tolerances that are established by
If we look at the wheat situation, for example, in the absence
of a tolerance or exemption from tolerance for residues of
fury on wheat, any wheat that bears or contains such residues
is adulterated. That is 4028(2)(B). That is one component
of the situation. Once you have a residue -- a detectable
residue -- in the product, then introduction or delivery for
introduction into interstate commerce of an adulterated food,
including wheat containing fury residues, is illegal. This
is among the prohibited acts. You know, introduction. So this
is the second pillar. You know, adulteration and interstate
commerce is the second component.
So such acts then, you know, may result in legal action, including
seizure, of the adulterated wheat. However, it can get worse.
And that is, if the wheat containing fury residues is commingled
with clean wheat, then the FDA considers the entire wheat
mixture to be adulterated. That is, blending can enormously
telescope the problem. We say dilution is not the solution.
It can actually be your worse nightmare, as I think everybody
involved in the Starling situation can attest to as probably
the grand example of that. So that's where we come from. Now,
we'll continue to work with EPA to address those pesticide
misuse problems, and we'll take enforcement action when we
find residues in food or feed shipped in interstate commerce.
I think it was already mentioned that we need a better process
coordination with them to deal with these situations. Now,
if we go back philosophically in the entire picture, what
might be our perspective? Well, you know, while we don't do
the risk assessments and we don't establish the tolerances,
we believe that the overall safety of the food supply with
respect to pesticide residues requires adherence to the use
of pesticides in accordance with the registered uses. It is
a fundamental construct upon which the pesticide safety system
is built and ensures exposure to residues are within evaluated
bounds. And the same kind of philosophy applies to, you know,
our regulation of food additives. You know, food additives
are safely used because of premarket clearance and they're
used in accordance with the program.
Also, the FDA, you know, is a strong proponent and strongly
believes that prevention is the best approach to ensure food
safety. Therefore, we would say that systems, programs, communications,
outreach, etc. need to be in place to ensure that pesticides
are used in accordance with registered uses so that we do
not need to get in the situation of refereeing consequences
of misuse and the commingling and so on that may go on. We
would really recommend that states take a strong position
against misuse to provide that incentive of assuring that
pesticides are used properly. We would also suggest that crop
protection companies need to ensure they train their sales
forces on the importance of adhering to registered uses, and
that they also do not jump the gun on anticipated registrations.
They need to maintain up to date, readily accessible information
on acceptable use of the products.
Then ultimately the farmers need ready access to information
to ensure that they're using the products, or their applicators
are using the products, appropriately, because ultimately
it is the responsibility of the farmer to assure the safety
of the crops, and the FD&C Act places squarely on the
farmer and not really on the applicator the responsibility.
I mean, they're their contractor. The farmer owns the crop.
The crop needs to be safe.
So those are my points. Thanks.
MS. LINDSAY: Okay. Thank you, Terry. Shelley, you're
up next. And I think Shelley is going to give us a little
bit different perspective on some other issues that are important
with regard to misuse.
MS. DAVIS: Thank you. I'm going to shift our focus
to misuse that involves worker safety issues. My colleagues
at the Pesticide Action Network, California Rural Legal Systems
Foundation, and the United Farmworkers of America did an analysis
of the California Department of Pesticide Regulations' Pesticide
Illness Surveillance Program data for the years 1999 to 2000.
And they saw some striking patterns of misuse that I want
to relate to you.
First of all, the California Department evaluated -- where
they get these illness reports are basically two sources --
workers compensation claims and physician reports -- and then
these instances are investigated by County Agricultural Commissioners.
And the investigation makes a determination as to whether
a pesticide exposure definitely, probably, possibly or did
not cause this illness. So we eliminated all instances where
they found there was no relationship with pesticide exposure
and focused on instances where there was definitely, probably
or possibly a pesticide exposure related illness. Then we
tried to hone in on migrant and seasonal agricultural worker
tasks so we could really look at, you know, the kind of issues
that we were most concerned about. We eliminated, for example,
livestock exposures or janitors who were exposed. We just
looked at agricultural workers in crop agriculture and turf
to come up with our analysis. And with that perspective in
mind, there were approximately 1,360 incidents in this three
year period. Now, this is only the tip of the iceberg, for
many reasons which, you know, we don't have to go into. But
even so, it was -- provided some very provocative data.
Two kinds of incidents accounted for 75 percent of these reported
cases. Drift alone accounted for 50 percent of these cases
over the three year period. Contamination by pesticide residue
accounted for another 25 percent. The Department further analyzed
this data to say whether or not a violation of a regulation
had been found. And this was very interesting also. With respect
to the drift cases, in 55 percent of the cases a violation
was found. With respect to the pesticide residue contamination
cases, a violation was found in 43 percent. Well, from our
perspective, these data really raise a lot of questions, maybe
more than they answer, and will require further analysis.
But let me give you some of our thinking on this, because
we think it bears on how good a job is done to regulate worker
First with respect to drift, just to keep in mind that frequently
in these cases more than 10 workers are injured in a single
incident because of the nature of usually affecting a whole
crew. The EPA has already begun to look at what is required
to regulate drift, but we would suggest that a lot of these
incidents where no violation was found really raises a question
about how adequately we're regulating drift. Because in a
lot of these cases, there was evidence that workers had symptoms,
the symptoms were consistent with the pesticide that was applied
in the adjacent field, and no drift violation was found. And
that in our minds really raises the question of whether or
not the regulations are adequate or the enforcement is adequate.
With regard to pesticide residues on the crop, when they cause
injury there really are a couple of different issues that
get raised. Sometimes workers are injured when they're put
back in a treated field because the reentry interval is not
long enough. And that's certainly a regulatory issue of concern,
and I think that issue bears closer scrutiny. In other instances,
the problem is really that there was not an adequate system
of notifying the workers. And this is California. This is
big agriculture. There is the grower. There's the crew. There's
the applicator. There are a lot of folks involved in these
processes and communication has to be good. And if the mechanisms
to communicate aren't good, then workers are going to get
In our view, one of the fundamental regulatory weaknesses
here is that farm workers don't have a right to know what
pesticides are used in the work areas in which they work.
That's comparable to that required for all other workers by
OSHA. And just to give you an idea of how we think this should
happen and how this would contribute to eliminating these
instances, workers should be told, for example, what are the
different pesticides applied on the plot they're working on.
What are the symptoms of exposure. What are the reentry intervals.
And when a particular spraying is being done and where that
data is available. And the field should be posted where reentry
intervals exceed 24 hours. If there were a good system of
information, then the workers themselves would be in a position
to know when reentering a particular field was inappropriate.
And right now, essentially workers are at the mercy of their
supervisors. And as these number of instances -- there were
336 incidents of workers being injured in a three year period
due to pesticide residues on the crops. So that shows that
the system is not working.
And so we would ask that a real close analysis be made of
this data to really highlight what are the failures in the
regulatory process and close them. And now is the time to
really make work place safety more than just a slogan.
MS. LINDSAY: Thank you, Shelley. And, Jay, I think
you get the honor of wrapping up the reaction panel.
MR. VROOM: Thank you, Anne. I would like to commend
the presentation that you and George and Van have made, because
I think that is a really elegant kind of summary and set of
observations about what has collectively been observed as
a trend that is of concern to all of us who regard ourselves
as stakeholders in this pesticide use community in the United
States. I think it is important -- and I believe there are
still some representatives of the press here -- for us to
make certain that while I think we would all regard that there
are troubling trends that have been measured and indicated
here, and are called in this section of the agenda nonisolated
misuse experiences, that it is not an epidemic. It is a trend
that is going in the wrong direction that we all want to correct.
But it is still less than a fraction of 1 percent of all the
pesticide applications in agriculture and nonagricultural
situations in the United States, and that the vast, vast majority
of pesticide uses are being applied in a manner that is in
some kind of connection with what the label directions are.
But there are troubling trends here in terms of these measured
and identified instances, some of which have resulted in enforcement
actions by the agency and state authorities. And certainly
are behalf of the registrant community, I think that I can
say that we are -- we share the concerns that have been expressed
and want to do something about the trend and reverse it.
I think it has already been stated clearly that there are
some sort of over arching issues that are behind what's happened.
Money or economic pressures on everyone that is involved in
the value chain here, whether it's growers, or whether it's
registrants. The number of registrants and the amount of resources
that our companies have available to and can place against
education and awareness and information.
Whether it's the government, either at the federal, regional
or state levels, including USDA's Extension Service, which
if you haven't noticed, thanks to agricultural reform that
the Congress has decided to enact over the last 10 or 15 years,
we don't have as many Extension agents in the field any more.
Or, you know, anywhere else you want to look, the economic
pressures are extraordinary, because farmers just don't make
as much money as they ought to be able to or that they used
to. Label confusion. I think Dan and others made an excellent
point about the fact that, you know, we've gone the wrong
direction in terms of the label being a part of the problem
as opposed to part of the solution in this area and the trend
that we're seeing is troubling.
And then lastly, it's all about the fact that, well, all the
things I just mentioned and others have mentioned are realities.
You know, economic pressures and label confusion. Too many
lawyers or whatever it is. Mother nature isn't waiting on
us. Mother nature is a journey that is continuous and provides
challenges to farmers and other pesticide users that is part
of a continuum. We have resistance, new outbreaks, weather
trends, new cropping ideas and opportunities that all sort
of make this a moving target.
And so I think we need to rededicate ourselves to trying to
do a better job of educating, whether it's better, more understandable
and functionable labels. But just having better labels doesn't
do any good if no one is taking time to read them or follow
We used to have a campaign that our organization conducted
when it was the National Ag Chemicals Association called the
farm chemical safety is in your hands. It was started in the
late '80's. You know, there were decals that were made available
to farmers through the Extension Service that were to be placed
on mixing and loading equipment that had the headline, rubber
glove zone, to remind mixer/loader applicators that they had
to wear rubber gloves and other protective equipment. You
know, it's been over 15 years since we had, you know, resources
from our association for that kind of an education effort.
So I think we've got to all agree that we need to get back
to the basics. Steve Johnson and I have talked at length about
this problem since he brought it up in remarks to our annual
meeting last fall. We finally both have written articles for
potential use in the trade press and the agricultural press
about this as one step to try to elevate the attention of
growers and other applicators and users with regard the troubling
trend line in terms of misuse.
And we've gotten one dealer trade association magazine to
agree to publish these two articles. But so far we've gone
sort of door to door around to the farm trade press and been
told repeatedly in the last few weeks, well, you know, we
just don't have as many pages of editorial content available
to reach farmers any more. Part of it is because pesticide
companies aren't buying advertising any more and so we can't
afford to have as many magazines or as many pages. And, you
know, it's all -- you know, where do you start. It's sort
of you find yourself in this vicious circle.
So we are concerned, I think, in the registrant community
as are everyone about the trend. It is still a very small
fraction of the pesticide uses, but a trend that we need to
stop and turn around.
MS. LINDSAY: Okay. Thank you, Jay. I think we've got
about 10 minutes left for some further reactions from the
rest of the panel. So if you would put your cards up, we'll
just go around. And I think, John, you were up first, so we'll
go counterclockwise this time.
JOHN: Thank you. Could you just say a little bit about
what you spoke about yesterday with respect to the spray drift
rules in the minute -- you know, the pesticides issue in a
minute and address Shelley's concerns in terms of the intersection
MS. LINDSAY: You mean repeat what I said yesterday?
JOHN: Well, just kind of address directly what she
mentioned in terms of 50 percent of the cases had to deal
with spray drift.
MS. LINDSAY: Well, she -- if you look in the paper
that we distributed at the break, you can actually see that
the analysis of the California incident data suggests that
spray drift is an actual factor in reported pesticide illnesses.
And I think that that is the kind of information and material
that EPA has thought about when we came out with our draft
PR notice, and it's the kind of material, along with all of
the comments that we received, that we'll have to be thinking
about as we develop our reproposal.
I don't think it's going to be, frankly, easy. We've heard
a whole lot about all of the challenges that a farmer faces.
The impact of whether drift is not the kind of thing, I'm
confident if we -- if I squirted a spray bottle of water here,
there would be drift in this room. So it's -- your goal is,
I think, for people not to experience those kinds of effects
that are reported in this. How you actually get there and
acknowledge all of the differences in agriculture is going
to be a real challenge. Win, I think you're next.
MR. HOCK: Yes. First of all, I would like to complement
Jay and the rubber glove zone. We used it for years in Pennsylvania.
In fact, I still have a few decals left that I'm hoarding.
But it was a great program and we did promote that. That was
Just a few comments about Extension. Jay commented about the
Extension Service. To give you an example of how things have
changed, when I first started we had county agents. Literally
county agents. Today, we don't hire county agents any more.
We hire regional agents. Because the counties can't afford
them. The states can't afford them. Federal funding has been
level for the last 20 years. In fact, the projection in Pennsylvania
is -- and I think I can speak for other states as well --
that if we look at Extension funding from the national level,
we predict in terms of real dollars by the year roughly 2020,
we'll be down to zero because of inflation. We'll still get
dollars, but it's going to be in essence worthless.
So we are concerned about that issue about funding. But again,
specialists. We're cutting specialists. Where we used to have
two or three weed specialists, we're lucky to have one. And
it goes on. For every position we -- for every two positions
we lose, we may be able to fill one. And like I said, at the
county level it's even worse. County agents are no longer
county agents. They're regional agents.
I would also like to comment about label confusion. Dan commented
about that and Jay. And I can tell you, in our business we
read a lot of labels at any land grant university, and there
are a lot of labels out there that literally we pull hair.
We don't know how to interpret them. You look at two products
that are the same active ingredient and you get two different
stories. And I would like to compliment the agency on the
label improvement program, because I think the future holds
that we will see better quality labels. More informative,
clear labels. I think this is a great way to go.
The other thing I just would like to ask Van in his report.
In those states where there were significant misuse problems,
such as you mentioned Arkansas, do you know the role, if any,
that the land grant university placed in this? Did they --
I mean, were they involved either in the problem or in the
solution? I'm just curious what role, if any, they played
in the knowledge that this occurred. Was it after the fact?
Were they involved in any of this?
MR. KOZAK: As near as we can tell, after the fact.
They assisted in spreading, you know, the appropriate education
in terms of what you shouldn't do. I mean, everybody in Arkansas
was busy trying to convince everyone if they were involved
in this to stop and take a breath, because it only impacted
about 1/2 percent of the wheat in Arkansas. But this involved
shutting down the storage facilities, making sure there wasn't
commingling and so on.
To the best of my knowledge, there were never any allegations
that the Extension Service had any involvement in spreading
this information. The consultants that were under investigation,
I think, were private consultants, and they continue to be
looked at by the state. But I hadn't heard anything with regard
to their involvement beforehand.
MS. LINDSAY: Win, before I move on to Julie, can I
just ask you. It's obvious that in whatever direction you
look there are resource constraints. Everyone has talked about
those. Do you nevertheless, though, see a role that the Extension
Service could really be playing, especially on the prevention
MR. HOCK: Yeah, absolutely. Our specialists, be they
entomology, plant pathology, horticulture, agronomy or even
wildlife areas where we use pesticide products. Absolutely.
It is one of our major responsibilities to work with grower
groups of all shades and forms. That is not just growers,
but that is PCOs, lawn care and what have you.
We have people in almost all the land grant schools that work
across the board. And Extension -- put it this way. Extension
in its strengthened state can be very effective, because they
still have quite an audience. Just to give an example, in
Pennsylvania through our certification and recertification
program for pesticide applicators, we have roughly 27 to 30,000
applicators every year come in for one kind of training or
another. That's about 80 percent or more of our certified
applicators every year come to some training course. That
may only be an hour, but it also could be two days.
So there is a lot of exposure to these kind of programs, and
certainly misuse could be one of the key topics in the upcoming
MS. LINDSAY: Okay. Thanks. Julie?
MS. SPAGNOLI: A number of years ago I think this whole
issue of labeling came to light with consumer products when
it became apparent that there was a lot of confusion out there
among consumers with the product labeling. And to that end
then, you know, the agency along with registrants and other
stakeholders got together and said let's try to fix the problem.
And I think one of the things we found there is that you had
to go to the users to find out where the problems were, because
what might seem absolutely clear to the person, you know,
developing the product or writing the label, it might not
necessarily be as clear to the user. And what I'm hearing
is it sounds like that's probably some of what's going on
I think especially with agricultural product labels, I think
these labels tend to evolve. They're not -- you know, as uses
are added and changes are made over the years, you know, label
changes might not all jive, and so there may be parts of the
label that seem to contradict each other.
So it seems that -- and after hearing what I'm hearing --
this may be another place for a -- you know, whether it be
kind of a task force or an initiative to get together with
the registrants and, you know, with the states, I think, because
the states are saying, you know, they're having problems interpreting
labels, and with, you know, the users and let's identify where
this confusion -- you know, where the confusion is coming.
Where are the places where we can, you know, make these changes
and hopefully clarify this.
Because I think, you know, from the manufacturer's standpoint,
of course, we -- and probably from a product stewardship standpoint
-- we of course want our products to be used properly, and
we want the labeling understood. And I think we would be,
you know, glad to try to work with other stakeholders to try
to make changes that we need to make.
MS. LINDSAY: Okay, thanks. Go ahead.
DR. WESTEE: I just want to make a general comment.
I'm new to the PPDC. This is my second meeting and I'm still
trying to find where I fit in this organization. I'm a family
physician, and for the last 22 years I've provided family
health care for migrant seasonal farmworkers and now am the
Medical Director of the Migrant Clinicians Network. I represent
1800 primary care providers for farmworkers.
And Van, when he was giving his comments, mentioned that the
enforcement issues on this misuse were driven by complaints.
And he stated that oftentimes it's a snitch, and I'll use
your term, a snitch that comes forward. And I said to myself,
and I was just kidding with Steve, that now I'm a snitch.
And when I was a kid, that wasn't -- that wasn't a term I
really liked. I kind of would like maybe outstanding snitch,
would be nice, or super snitch.
DR. ZUROWESTE: But I think what this says is we, as
primary care providers, and as Shelley was saying, are oftentimes
the person that the farmworker comes in with a misuse episode.
And so I think that I'll be happy to take that as a super
snitch position here. But I think it's very important that
you can have great policies, and you can have great guidelines,
but without enforcement, it really is very inadequate. So
I just want to reassure the rest of the panel that I will
continue to provide that snitchiness while I'm here.
MS. LINDSAY: You'll have the honorary snitch title.
DR. LOCKWOOD: Yeah, thank you. Wrong Alan, I think.
MALE SPEAKER: That Alan.
DR. LOCKWOOD: We heard information from George and
Shelley about documented instances of misuse or worker illness.
I think from a public health perspective, it would be important
to know whether this is the tip of the iceberg that we're
looking at or how much of the iceberg is sticking out of the
Of course, this has other implications as well. I mean, I
made some derisive comments earlier about cost. But you're
talking about the cost of preventive measures in terms of
better education and better training of applicators. In public
health, that's almost always the case, that prevention is
less expensive than dealing with the problem afterwards. So
you're talking about a farmer who loses a crop, or a farmworker
who is ill and has economic losses, as well as a cost to the
health care system.
In terms of the magnitude of this problem, it would be important
to know how pervasive these problems really are rather than
just hearing about the isolated instances that we heard about
this morning, as important as they are.
MS. LINDSAY: Okay. The next Alan.
MR. JAMES: One of the challenges on resources is that
also not only are Extension agents not funded as they were.
Many Extension agents today are serving urban areas. They
were trained as farm Extension agents and agricultural Extension
agents at their land grant universities for the most part,
but many Extension agents are sometimes now called horticultural
agents and have been taken into cities because of suburban
growth. They are not as well trained in that area for urban
pest management as they had been for farm pest or horticultural
Our association has developed a training program. We take
a number of agents each year that have urban responsibility
and work with them on integrated pest management and label
understanding for consumers, as well as for professional applicators.
What we have found, to answer your question earlier, through
our consumer surveys is that Extension agents remain the most
credible third party source of information for urban pesticide
users where there is an Extension agent available to them.
Too many urban areas don't have Extension Services any more.
They've not just been absorbed. They've been done away with
from lack of funding.
So we're trying to help those agents that are now in urban
areas to be better prepared to answer questions about understanding
pesticide labels, integrated pest management and our responsible
use of the products.
MS. LINDSAY: Thank you. I think as just one follow
up. I think, Alan, your comments are a reminder to the group,
that although our examples were agricultural, you have the
same opportunities. And we actually have some history with
some fairly significant urban misuse cases that were at least
as costly, if not more so. So that urban context is just as
significant here as the ag world context.
MS. POPOWITZ: Yeah. My comments, which I sketched down
quite a while ago, actually, hit on a lot of the things that
were brought up. But, again, to put it into my perspective,
which is a public health perspective, there is a lot of robust
data out there. I would go it robust from a scientific perspective
as best as we can put this together in terms of field studies
of exposures or exposure hazard scenarios. For instance, field
workers who aren't provided with hand washing materials and
yet eat in the field, or may or may not be provided with drinking
water, or may or may not be provided with cups for the drinking
water so they might use their hands, which they've been working
in the fields.
So there are a lot of scenarios in support of what Shelley
was saying that lead to exposure risk or even poisoning events.
And a lot of these, as Alan was commenting on, and maybe add
a bit to, is that a lot of these are not reported to their
physicians. They're not reported to anybody that is going
to collect that information and put it into some kind of statistical
database collecting system. It doesn't get to the part where
it gets into a study like this. That's my point.
So not only is it a value to put together some of these kinds
of studies, I think that these should be considered as red
flags or tips of the iceberg where we need to put some energy
and some concern into what probably is closer to what might
be characterized as an epidemic, at least in certain areas
regionally or in certain work scenarios in the field where
we have large scale exposures. They might not be exposures
that are causing the kinds of illnesses that might be leading
to work loss. They might be just leading to what we would
classify as malays or a sickness.
But nobody should have to go to work and come home sick, I
don't think. We should expect that of workers, that they don't
need to be made sick in their work place. So I think in support
of Shelley, the state is important. The public health implications,
both costs in terms of downtime, or loss of work time, or
loss of productivity, but also costs in terms of comfort and
health needs to be conserved very seriously and incorporated
MS. LINDSAY: Okay, thank you. And -- yeah, I do so
Melody. And I think you are the -- you get the last word on
MS. KAWAMOTO: Thanks. I want to make three points,
and I'll start with the easiest one, which is what Jay had
said something about rubber glove use. As the National Institute
for Occupational Safety and Health, we do not encourage the
use of rubber gloves when it is not necessary to use rubber
because of the allergy issue. So it would be better to call
them protective gloves.
MS. KAWAMOTO: I think that's the easiest one. The second
issue has to do -- I do want to emphasize or highlight what
Alan James had said about nonagricultural settings in which
there are cases of misuse. And we get those kinds of incidents
reported to us in buildings when it is misused or -- and I
don't know if that's -- it's probably a violation where they
use the wrong thing, or they use too much of it. Because I've
seen uses of insecticides when a rodenticide should have been
used and the people who work in the building get exposed and
I've seen some cases where quite a few people get sick.
The other thing about that is that those are entirely preventable,
which leads to the bigger question of information and who
needs this information. Who should get trained. We talked
about, well, maybe the producers should be trained as well
as the applicators. But when you think of it, it's really
a bigger issue than that. Maybe it's families. Maybe it's
children. Maybe it's everybody who should be trained, especially
with the pervasive use of pesticides. And when does this happen.
Do we do it for people who are just going to be exposed, or
maybe it should be done at a much earlier age.
And I know that the EPA on their web site has a lot of information
for kids. I think there is a page for kids, which I think
is really great. But it would be really good if that could
be started in the school system rather than, you know, something
just on the Internet.
And what is the message for the public. We get a lot of advertisements
from the producers and not as much from the public interest,
although the public interest information is out there but
less accessible. And how is the information transmitted. Is
it in an interesting way that engages people.
And then one of the things that we're concerned about in occupational
health is OSHA requires training, as EPA does, but how well
is it understood. Is it understood well enough to be put into
practice. So these are the kinds of issues that I think really
should be looked into and discussed, because without answers
for those, I don't think there's going to be much of a change
in the culture. And this is really tough, because there are
a lot of other factors that go into each of these questions.
But it should be addressed.
MS. LINDSAY: Okay.
MR. KOZAK: Anne, may I make one quick clarification?
MS. LINDSAY: Sure.
MR. KOZAK: There was a comment made about the business
of complaint driven programs. I wanted to make sure the folks
didn't interpret that in a broad sense. The point that I was
trying to make was that basically many of these state programs
have robust surveillance activities. But when it comes to
these misuse issues, like the ones we were discussing earlier
where a product is being misused by an individual farmer or
several farmers, there is not a lot of opportunity for surveillance
activities. Typically those are brought to our attention by
somebody who picks up that the activity is going on and we
get a complaint.
So I didn't want -- when I said that many of the pesticide
programs are complaint driven, I was referring more specifically
to that kind of case, because we have a lot of ongoing surveillance
in all the states depending on the program area.
MS. LINDSAY: Okay. I want to thank everybody.
MS. MULKEY: Wait a minute.
MS. LINDSAY: Oh, Win. All right.
MR. HOCK: I promise I won't be long. Just a couple
quick comments, one about what Alan James had said. In Pennsylvania
-- and again, I'm using Pennsylvania because that's my state,
but it basically covers Pennsylvania, New Jersey and others.
The largest agricultural, quote, horticultural show in Pennsylvania
is Pennsylvania Flower Show. It attracts 300 to 400,000 --
300,000 people a year.
And you know what most of the questions are when they come
to the Extension booth? Something with pest management. Something
dealing -- how do I control XYZ pest. In fact, when I worked
down there, I got more questions on deer damage than anything
else. And I said call EPA.
FEMALE SPEAKER: Thank you, Win.
MS. LINDSAY: We're going to refer them to you.
MR. HOCK: The other issue I just want to address is
something that Melody eluded to. One of the big issues we're
dealing with is West Nile Virus in Pennsylvania and the use
of repellents. And we have a major program that deals with
the use of repellents. It's addressed to homeowners. Because
the first year when West Nile came around, people were literally
saturating themselves and there were all kinds of concerns
about rashes, and I don't feel good, and all this kind of
So, again, I really echo this thing. We have an urban environment
that we've got to deal with as well as the traditional agricultural
MS. LINDSAY: Okay. Thank you. I'm going to try one
more time to thank everybody for their participation and observations.
I will say that the discussion here has actually -- I thought
I had thought a lot about the topic in preparation for the
meeting. But all of your observations and contributions have
actually broadened my perspective on the issues.
There is obviously -- I think it's really obvious that an
ounce of prevention is worth a pound of cure, and as much
as possible, I think we need to all dedicate our efforts in
that direction. There is a world of opportunity in terms of
training, education and outreach. It sounds to me like what
we really need to be shooting for is something that is continuous.
Not the sort of one shot, we've done it, stop.
But there are also, I think, opportunities. We've heard a
lot about labeling and other kinds of regulation. I think
better use of data that we're getting from the field, to go
back and look at how we're incorporating that into our decision
making processes. And it's a problem that no one of us is
going to solve on our own. So this is a case, I think, where
we're going to need to be working collectively and together
over the future.
MS. MULKEY: Well, thanks to the panel. We are still
okay on time. I know it's -- those of us who are still here
feel a sense of loss about the folks who were not able to
still be here in terms of the remainder of our work. But assuming
that there are still among us a critical mass, I think we
will have time at the very end of the day's schedule -- because
we do not apparently have public commenters. We will still
have ample opportunity for a forward looking discussion.
And in anticipation of that, I would like you to be thinking
among yourselves and prepare to have some thoughts about how
can we have an effective follow through for those topics we've
worked through which clearly warrant that. I mean, this topic
was just done as an excellent example of one where some alliances
could be formed. Some projects could be taken on. Some effort
could be expended. And I think the agency is prepared to be
a -- to play a facilitating role, but we look to you folks
for some leadership around some of those kinds of ideas.
So with that in the back of your minds, let's move back to
updates. And if Joe will do his updates so that he finishes
with the one we asked him to do about sort of the basics of
the current state of play with regard to maintenance fees,
tolerance fees and our budget, then that will -- we can have
Jay plan then to provide a perspective based on his recent
experience trying to focus on these issues. And that allows
the last discussion before the wrap up to have that as part
of the subject matter.
MR. MERENDA: Good. Thank you, Marcia. I've been asked
to cover two topics, the first of which has to do with environmental
performance measures. And given that these are supposed to
be updates in a minute, I will try to be concise. The main
purpose in having this topic on the agenda is to alert members
of the PPDC to two opportunities for input into agency wide
activities that will be coming up in the next few months,
quite possibly before the next meeting of the PPDC, so that
you are aware and can be fully participating in those activities.
But to try to put this topic into a very brief context in
terms of the Government Performance and Results Act, which
in part is driving both of these activities, I guess the simplest
way I can put the concept of the Government Performance and
Results Act is that it says government shouldn't run on autopilot.
We shouldn't just keep doing what we do because that's what
we do and that's what we know how to do best.
Rather, the direction of that legislation and the philosophy
behind it is that government needs to focus on what are its
objectives. What are the priority things it's trying to accomplish.
It should identify direct measures of accomplishment in those
areas and then set and adjust strategies to achieve those
It is, I think, a very sound management concept. One that
I'm sure all of you in your operations try to follow the same
principals. There are some complications as in any sound management
approach to really define what the goals are and to convert
them into effective measures, and that is primarily what we're
talking about here.
The first of the two opportunities that I want to talk about
briefly is a core part of EPA's implementation. All agencies,
for that matter, implementation of the Government Performance
and Results Act. And that is, each agency is required to have
and to update every three years a strategic plan. The strategic
plan update process is once again starting within EPA. The
updated EPA strategic plan is due to the Office of Management
and Budget in the fall of 2003. So there is about a year and
a quarter of process which is just beginning now that you
will be having opportunities to participate in.
The process, however, may move, at least in certain parts
of it, fairly quickly. And so that's why I think it's important
-- even though the full details of how the strategic plan
update will be carried out are still being formulated within
EPA, it's important for you to know that this is going on
and a little bit about the time line.
You may recall that roughly three years ago there was an update
of EPA's strategic plan. That was actually the first update
in 2000. At that point, the agency early on set some fairly
narrow goals for the update. Basically the agency decided
that the current 10 strategic goals of EPA would be maintained,
that there would be a good deal of public and stakeholder
participation in discussing how to achieve those goals, and
what the objectives should be under those goals. But the basic
goals structure was held constant from the start.
That is not the case for this round, the 2003 update, to the
EPA strategic plan. At least at this stage, the field is pretty
wide open, as I understand it, in the agency consideration
of this process to look at the basic goal structure. The agency
may end up with different goals. My guess is the agency is
more likely to end up with fewer goals rather than more goals
if there is a change in the number. But there may be substantial
changes in the direction.
The initial rounds of public input and stakeholder input are
likely to be sought over the course of this summer and fall.
So this one is basically the early warning portion of this
topic. The strategic plan update is happening starting now.
There will be opportunities -- this is being done on an agency
wide basis, so I'm not sure exactly how groups like PPDC will
participate in that process. There will undoubtedly be some
agency wide activities carried out to seek input on what the
goals should be, what the objectives should be, and feedback
on how the strategic planning process in EPA is proceeding
and what can be done to make it more effective. But just be
alert that that is something that is coming up.
The other half of this topic that I wanted to speak briefly
on is something which is further along. There is a brief two
page fact sheet that was in your folders about something that
Governor Widman is calling the EPA Environmental Indicators
Initiative, and also the EPA State of the Environment Report
is directly related to that. This fits into the strategic
plan and into the Government Performance and Results Act in
the sense of trying to address what are the measures of environmental
outcome that EPA has available to it to assess how we're doing.
And, of course, without data it's hard to measure performance.
As I mentioned, this is an agency wide effort, the Environmental
Indicators Initiative. It is co-led by EPA's Office of Research
& Development and EPA's Office of Environmental Information.
It is agency wide. There are various work groups that are
across all of the offices, including the Office of Prevention,
Pesticides and Toxic Substances, that are participating in
that process. The structure is outlined in the fact sheet
that was enclosed in your folders.
To summarize it, it has been decided there will be five major
parts to EPA's State of the Environment Report. Those will
be human health, ecological health, clean air, pure water
and better protected land. There will be measures related
to pesticide activities in several of those. Exactly what
measures will be included in the State of the Environment
Report is still being worked out through the various work
groups. But at this point, we anticipate that there will be
pesticide related measures showing up definitely in the human
health and ecological health portions and in the better protected
land section, and there will be topics that are at least closely
related to pesticide activities undoubtedly in the pure water
section where water contamination will be addressed.
In addition to the State of the Environment Report, which
is being designed to be a general public document, something
that is hopefully accessible to and understandable by the
American public at large, there is intended to be a technical
support document that will provide considerably greater detail
on the individual measures that will be discussed in the State
of the Environment Report, the basis behind them and some
of the data sources that are used to evaluate them.
Turning to public participation in this process, that has
already begun. At the end of April, Governor Widman met with
the ecological -- excuse me -- the Environmental Council of
States, the group of state environment agency representatives,
to give them an overview of the process and to ask for their
input. There will probably be some additional opportunities
for comment focused on state groups, and my understanding
is that there is an interest in reaching out not just to the
environmental components of the states, but also to the agricultural
and health departments of state government in this process.
All of this will be leading to a public discussion draft of
the State of the Environment Report, which is currently targeted
for release in the late fall. I believe November is the current
target date, but I don't know if that is absolutely firm.
It is viewed as a public discussion draft, because the intent
is not to say this is a final report on the state of the environment,
but rather to be an opportunity to seek much broader input
from many of the groups who are participating in the PPDC.
So this is an ongoing activity. The goal of the agency is
to have this be a periodically updated report, one which will
look at trends, and I'm sure we will be looking for a good
bit of input on how we're doing.
To focus in even a little bit more specifically in the pesticide
area, I won't take the time to try to go through a number
of the specific performance measures that have currently been
proposed and are being considered for the State of the Environment
Report. And some of those that are in there may be modified
or may not end up in the final report, because the report
right now has far more topics and issues and potential measures
in it than will fit. There are ongoing discussions of a steering
committee and various work groups looking for ways to consolidate
information and focus more sharply.
But just to give a few examples from the pesticide perspective,
there are -- at least what we're looking at performance measures
within the Office of Pesticide Programs and elsewhere within
the agency, I think you can look at it as potentially five
tiers in a hierarchy of outcome measures that we're looking
at. The lowest tier, the one which depending on one's philosophical
purity to outcome orientation under the Government Performance
and Results Act, is either just below or barely within the
scope of what I would call targeted outputs.
These are output measures, but looking toward specific strategic
or problematic objectives. An example of that that the pesticide
program has already included in our GPRA measures is looking
at our performance in reassessing --
(End of Tape 5, Side A.)
MR. MERENDA: -- quickly tracking as an output measure,
but a targeted output measure, how we're doing on those.
Moving up the hierarchy, the next area, which is certainly
within the GPRA outcome measure philosophy and the State of
the Environment Report approach, is what some people call
environmental pressures. These are inputs to the environmental
state. An example in the pesticide area that we're looking
at is the percent of acre treatments that use reduced risk
pesticides. How well are we doing in moving to reduced risk
Another example which is under consideration for the State
of the Environment Report of a similar type is percent of
acre treatments that involve use of pesticides classified
as highly toxic to birds or fish. How are we changing over
time with respect to the types of pesticides that are being
used. Are pesticides with lower toxicity to nontarget organisms
taking a bigger share of the market or not.
The third level in the hierarchy is actual environmental levels
of exposures. The two primary examples that I cite in the
pesticide program that we are pursuing in that area, one with
respect to human health is using the Department of Agriculture's
Pesticide Data Program residue data on foods. We're specifically
looking at residues of neurotoxic and carcinogenic pesticides
on children's foods as one measure. And another environmental
measure that we're trying to pursue is use of the Department
of Interior's National Water Quality Assessment Program data
for water quality to look at the level of pesticide residues
in surface and ground water.
The ultimate tier, if you will, is human body burden -- or
environmental body burden data. Not human body burden data.
An example of that that we are looking at is the use of Inhain's
data on pesticide metabolites. And then the final tier of
the hierarchy is actual health status, whether it be human
health or ecological health. I think a good example of that
is the type of information that Shelley Davis described from
the farmworker poisonings. What is actually happening in the
health status of the community. And likewise in the ecological
area, we are looking at ways of using environmental incident
data which are available to EPA as an indicator to look at
how we're performing.
Well, that is in a nutshell -- certainly not in a minute,
but hopefully within the allowed time -- a bit of an overview
on some of the current things we're doing on performance measures,
and also the particular context of these two agency wide activities
that hopefully many of you and the organizations that you
are part of will join with EPA in the discussions of.
So I turn at this point to the resources issue. The original
topic that was on the agenda was a fairly narrow one, at least
as I understood it, registration resources. But Marcia asked
for a brief overview of the broader resource picture, so let
me try to do that and then do a very quick presentation on
the registration resource information. I'm not precisely sure
that the information I brought is what everyone wanted to
talk about on registration resources, but we can have some
dialogue. And if it's not the right information, perhaps through
either a follow up dialogue or a subsequent meeting we can
provide additional information.
With respect to the overall pesticide resources, I think the
key issues that Marcia mentioned have to do with fees. To
put it in context, approximately 25 percent of the EPA headquarters
pesticide program personnel are paid for -- their salaries
are paid for -- through pesticide fees, principally through
the -- at this point through the maintenance fees, and a much
smaller portion, roughly 10 percent, of our fee income comes
from the current tolerance fees.
The maintenance fees have been in effect for some time. They
were extended through fiscal year 2001 by the Food Quality
Protection Act. They were extended for one additional year
-- that's the current fiscal year 2002 -- by the Congress
in the 2002 appropriation language. There was language in
the farm bill -- in various drafts of the farm bill at least
-- that would have had a further extension of the maintenance
But my understanding is that the farm bill which had now been
passed, in the final bill that language did not remain. Fees
are not part of the farm bill, so fees are very much back
to the situation we were in about this time a year ago with
the maintenance fees expiring in the end of September of this
year and the question of how resources for the ongoing pesticide
program activities will be funded.
The President's 2003 budget request is based upon the assumption
that the maintenance fees would expire and that fee income
now received through the maintenance fees and through the
current tolerance fees would be replaced by the revised tolerance
fees. The tolerance fee issue, as many of you are familiar
with -- but some of you may not be so familiar with -- has
to do with the expansion of tolerance coverage by the Food
Quality Protection Act in 1996 and also the
reencouragement through FQPA of EPA to establish tolerance
fees at a level that would fully support tolerance activities.
Not just tolerance petitions as had been previously funded
through tolerance fees, but also tolerance reassessments and,
of course, the broadened application of tolerances to inerts
and Section 18's and so forth.
There was a pesticide tolerance fee revision rule that was
proposed by EPA in 1999. I think I can briefly say that there
was considerable controversy in the public comment about who
should pay how much for tolerance fees. EPA considered those
comments and prepared language for a final rule to go into
effective, but for the last three years, this issue has been
an issue of considerable congressional attention. The last
three appropriation bills have included language that has
prohibited EPA from finalizing the tolerance fee rule as proposed.
And as I mentioned, the 2002 appropriation bill actually extended
the maintenance fees, which also eliminated the third of the
triumvirate of fees that we sometimes talk about. The registration
fee, which long predates my involvement with the pesticide
program, but I believe went briefly into effect around 1988,
was challenged in the courts. It was prohibited by Congress
from its further application so long as maintenance fees were
in effect, which is, I guess, waiting in at least the legal
wings for reinstatement at the time the maintenance fees go
out of operation unless a consolidated fee process comes into
So that's kind of the short picture on fees. Apart from fees,
I'm sure many of you have long since heard reports on the
fiscal 2003 President's budget request which is now before
the Congress. Generally with respect to the pesticide program,
the funding is level with respect to 2002 with, I guess, two
exceptions that I should point out.
First off is a general exception in the way that the Executive
Branch over the last several years has interacted with the
congressional branch of government on the budgetary process.
The Congress provides add ons in the appropriation bill. When
the Executive Branch proposes its budget, it strips out those
add ons. It goes back to the base budget. And so there are
add ons, one of which was a one and a half million dollar
increase for reduced risk registration in the fiscal 2002
appropriation. That's not in the fiscal 2003 President's budget
request, not because of any decision on the part of the agency
that we want to cut back on the registration program, but
because that is the way it's done in the budget process.
The other side of the ledger with respect to the pesticide
program is that there is a proposal for a two million dollar
increase in funding for pesticide programs for inerts registration
activities and for antimicrobial pesticide reregistration
So overall the pesticide program budget is basically a flat
budget as requested by the President relative to where the
appropriated level is for 2002, but there are these differences
of the reduced risk registration add on going away and the
increase for antimicrobial reregistration and for inerts registration
If we can put on the two slides, turning to the topic of registration
resources. It looks like we've got it on one -- or we've got
it on both. And I guess my choice of colors were -- or Lotus
Freelance's choice of colors -- because I didn't play with
it. I would have done better to choose yellow against that
But hopefully you can see the wavy line. This one is the nonsalary
dollars over the last five years. It actually shows a fair
amount of fluctuation, but a somewhat increasing trend for
registration across the board. Now, this is -- this is our
resources for registration activities for conventional chemicals,
reduced risk, biopesticides and antimicrobials all lumped
together, and this is the combined resources. As I understand
from the budget people who provided me with the numbers, the
combined resources across the pesticide program, so this would
include the science divisions, the actual risk management
registering divisions and the support activities for information
management and so forth within the Office of Pesticide Programs.
MALE SPEAKER: This isn't just RD, right?
MR. MERENDA: This is not just RD. This is total.
MS. MULKEY: This is nonsalary.
MR. MERENDA: Nonsalary. This is contracts, grants,
training, travel. Everything except salary. And, Pineapple,
if you can flip to the other slide, which should be the --
if you hit page up, I think it will go to the other one, which
should be the FDE history over the same five years. There
I was actually rather surprised when I looked at these numbers,
because it's not on there, but the overall trend for FTE over
those five years for the pesticide program as a whole has
been downward, and the FTE for pesticide registration, again
the same measure looking across the entire program, not just
the Registration Division, has actually been a slight upward
trend. I would have expected it to be at least a somewhat
downward trend as part of the overall -- a significant downward
trend in OPP staffing levels. But these are the numbers.
So with that, maybe we can either -- I don't know. Marcia,
do you want to have Jay go next and then do questions?
MS. MULKEY: Yes. And let's get the lights back up.
MR. VROOM: Joe, what is the total for that Office of
Pesticide Programs budget? You said flat, but just so we all
have a relative idea of how many dollars it is. It's 150 or
160 million? What is it?
MR. MERENDA: Yeah. I --
MR. VROOM: Marcia, I thought maybe it was in your annual
MR. MERENDA: It's the kind of number I should have
on the top of my head and don't. It's I think just under 200
MR. VROOM: Okay.
MR. MERENDA: Counting the fees and salaries -- appropriated
salaries -- and these other resources.
MR. VROOM: Yeah. Okay. The other nuance that you didn't
mention is that there is a difference between where fee revenue
can go between the three categories of fees. Tolerance fees
and reregistration and maintenance fees, according to statute,
do have a home to come directly to the program. Registration
fees go to the general Treasury fund.
And so by way of now being in a position once again like we
were a year ago, as you pointed out, of being on the brink
of having the maintenance fee authority expire and the prohibition
against registration fees kick back in, it's not necessarily
a wash for the net resources available from fees for support
of the program. In other words, unless Congress in some additional
grand wisdom decides to do something, that in my opinion would
have been easier in the farm bill, but they didn't, you know,
we're going to run up against the same sort of edge of the
cliff and, you know, one of these years we're going to fall
off the cliff.
And I think, you know, aside from all of the politics that
are associated with all of our individual positions sitting
around this table and for those who are maybe now represented
by empty chairs, as members of the Pesticide Program Dialogue
Committee, who I think we all bear some responsibility for
giving advice and counsel to the agency's management, both
career and political about how to run the program appropriately,
you know, we're facing a potential crisis in terms of operations,
Marcia. I think you would agree with that.
But, I mean, here we are. What are you going to do if we get
-- we're four months away from the end of the government's
fiscal year. You've got some 200 or so employees in reregistration
that are at risk again and, you know, that creates certainly
-- even if it doesn't happen -- a distraction for management
for those employees who are sitting there saying, you know,
am I going to get a pink slip on the 30th of September.
I really thought that Senator Harkins' solution, which was
in the Senate version of the farm bill, provided tremendous
opportunity for a compromise that would have allowed us to
get more certainty and continuity in this resource area from
the fee side resolved, so that we could also address the other
larger, you know, resource issues, including potential other
fees, in a context where certainty of what we have had to
deal with in the last three years, as Joe pointed out, of
coming up to the end of the fiscal year and having appropriations
writers address these issues.
And so I think we're in an unfortunate situation where even
at the worst -- absolute worst case estimate of what it would
have cost in the arcane world of budget scoring between CBO
and OMB and whoever else in the alphabet soup gets to play
in this funny business of counting money when Congress starts
to make these kinds of decisions.
Two hundred and twenty million dollars in a farm bill that
is going to now -- I guess CBO says -- run in excess of 82
billion dollars more than what anybody thought the Congress
intended to spend in the farm bill, is a tragedy. But it's,
you know, the ultimate in stupidity, and I've been telling
that to members of Congress who have been willing to listen
to me in the last few days.
So I don't know what we're going to do to solve this, but
I just think it's important that this group understands that,
you know, we are back in the same situation we've been in
for the last two or three years of having uncertainty from
management to figure out, you know, what are you going to
do. Every day we get closer to September 30 without, you know,
this problem being solved. You know, it just increases the
magnitude of the problem that you have to deal with.
Thank you for the time to editorialize.
MS. MULKEY: You're welcome.
MR. VROOM: I'm sure none of you care about what I really
think about this.
MS. MULKEY: I want to take some -- we are about to
run out of time, and I do want a little wrap up time. But
questions, either for Joe or for Jay on these topics?
MR. MERENDA: We are planning to hold a carwash --
MR. MERENDA: -- the fourth Saturday of July and through
MS. MULKEY: The uncertainty about -- I will say that
after a fairly long career now in the federal government,
uncertainty about federal budgets can be a source of stress
under the best of circumstances. And I suppose I could also
get away with saying these are not the best of circumstances.
But one trusts that the democratic processes, which of course
include all of you, some more actively than others, will at
the end of the day sort this out somehow. But it takes a lot
of work to be on trust to help assure that.
I really want to thank all of you, and including those who
really worked hard but don't happen to be here at this moment,
for a day and a half of what appeared to us to be extremely
productive work. You will remember that at the end of the
last meeting there was a dialogue about how long these meetings
ought to be, and there was a fair amount of sentiment for
three days. At least two full days. And I think it was a sense
that the time we had spent together last time maybe was --
did not give a sense of -- as much sense of accomplishment
as was optimal.
So one of the things I'm interested to see in the few minutes
we have left is whether you have any thoughts about how much
time makes sense in light of this experience. We're trying
to learn lessons as we go along. We're trying to listen to
you. We're trying to also think, as Larry always advises us
to, about our needs with regard to the advisory committee.
I think that -- here are a few thoughts about that. One is
that this electronic forum provides some real help to us.
And although we're just beginning to make it work for us,
it does appear to open up an opportunity for further dialogue
and for forward looking dialogue in anticipation of these
meetings. And so I'm hoping that we will all invest in seeing
whether we can make that more meaningful.
And toward that end, I'm going to commit us to look back over
this meeting and consider posing some specific questions to
you in that forum about next steps, and specific invitations
to you to consider what I'm inclined to call sort of ad hoc
alliances on some of these topics. Something well short of
a work group, but more than just talking to each other in
this forum or in the electronic forum.
And so I want to sort of poke at that and see if we can come
up with some thoughts that would provide enough leadership
from us to facilitate or catalyze some of that kind of thing
without requiring us to host, manage, do the homework for
and otherwise invest heavily, and the opportunity to take
advantage of some synergies. It's obviously not every topic
that warrants that kind of thing.
And I also invite you to use that forum for feedback about
this meeting and other things, so that if you don't feel you
have enough opportunity in the three minutes or so remaining,
that we still hear all the voices. And so without more on
that topic, I would like to make -- give one last opportunity
for folks to give us feedback about this meeting, the future
and the particular timing and length. That's always important
to hear, although, again, we don't have to hear that only
With respect to timing, I think it's dependent somewhat on
how many and what activities relate to the CARAT Advisory
Committee. It is dependent somewhat on how we survive the
window of time between now and August 3rd as far as our strength
and other measures. And it depends somewhat on things like
availability and timing. But we are currently aiming no early
than September for the next PPDC meeting, but probably more
likely October or even November. But part of what we would
like to know is your feedback about that kind of urgency.
All right. Well, let's take a few minutes for the flags that
can still fly, and apparently Bob still does, so I'll call
MR. HOLM: Well, I just want to comment. I think it
was an extremely productive meeting. I learned a lot. I'm
quite excited about some opportunities for follow up. I think
one thing that made it so productive is that there was a lot
of groundwork by different groups beforehand. And I think
I participated in the biopesticide one. We had conference
calls. We had dialogue between the participants, so that we
were prepared to come in with a presentation. And I think
those prepreparations really help and make things go much
And just to give you some feedback on some follow up, I just
talked to Kathleen this morning. We have a BPPD/IR-4 technical
working group meeting coming up June 10th, and one of the
issues we're putting on the agenda is just a follow up from
yesterday's discussion and try to put some framework around
So I do compliment your suggestion on building alliances,
and I think we can start to do a lot of that. And since I'm
a steering committee member of BPIA, I can roll that into
that part. So I think that's very helpful.
From this morning's discussion, I think it would be very helpful
for the next meeting to have the Section 18 process on the
agenda again, capturing the feedback that you get from the
public comment and I think, you know, maybe answering some
questions. I think there is some misunderstanding of some
of the members about the process, and maybe that thought process
could help a bit.
I really think that we ought to be thinking about the Section
18 process in a bigger picture as a strategic issue as being
part of FQPA transition, because I really do believe that
with the focus on reduced risk chemistries and the need to
get these chemistries in the market, and the role that the
Section 18 process plays can be a very important part of that
MS. MULKEY: Well, thanks. I will say that the work
that was done by folks who are not within OPP, but are within
EPA or other government, as well as members of the committee
-- and folks who are not in government, too, like the Bayer
executive -- helped us to prepare for this without an undue
drain on our resources, but with an opportunity to bring to
the table collectively a lot.
MS. SPAGNOLI: Just to, I think, reinforce some of that.
I think the idea of a follow up -- as we did with some of
the issues from the last meeting. To have a follow up and
kind of know, you know, what happened as a result of some
of the feedback that was obtained. I think that that's very
helpful and kind of gives it a sense of -- that you feel like
what you contributed or what was done actually had some outcome.
So I think that that would be something I would recommend
for the topics that were discussed this meeting to have a
Also, I like the idea of having that format of having some
prepared presentations and then having a discussion afterwards.
I think that that made it much more of a flow, yet you got
a good perspective of responses to those topics from, you
know, the committee. So I think that format was very, very
MS. MULKEY: Thank you. Troy?
MR. SIEDEL: Yeah. I would just like to echo Julie's
comments with regard to the formats. Meeting length, again,
was I think quite appropriate. And I would like to support
your suggestion with respect to whether it's casual alliance
format or something more formal for issues that do require
an ongoing review.
And, of course, the issue that I would be most interested
in for the moment is the animal testing and alternatives,
given the short term, medium term and long term considerations
in that area, and since every time we talk about registration
of a pesticide and data requirements, by and large we're talking
about animal tests. And the more we can move away from that,
I think that has been clearly articulated as an EPA priority
by Steve Johnson, and the more interaction we can see happening
between the program offices and ORD to push the peanut forward,
I think, would be strongly supported by many stakeholders
around the table.
MS. MULKEY: Okay. Warren?
MR. STICKLE: Well, I think Julie's idea of a follow
up to the issues that we've talked about at this meeting I
think would be very useful, just as we've had a discussion
at this meeting what happened at the last meeting. I think
that's a very good follow through.
Secondly, the update in a minute I thought was a very effective
way of covering a lot of topics and getting right to the essence
of those topics, and I would really recommend that you continue
to consider doing something like that at future meetings.
And thirdly, if you're looking for potential dates, I think
September is a perfect time to do that, as long as you avoid
the first full week in September, because there are two associations
that have meetings that week, and I don't know if any other
meetings or workshops that go on the rest of the month. But
starting in October and going through the second week of December,
there seems to be a meeting, convention or workshop for some
group around the table in October, November and early December.
So it's a busy full.
MS. MULKEY: That's helpful input. September is the
last month of our fiscal year, however, so it has some special
challenges from us.
MR. STICKLE: In that case, probably the second week
is better than the fourth week.
MS. MULKEY: All right, thank you. Anybody else? Well,
thank you all. I take it we still don't have any public commenters
signed up, right?
MS. SPAGNOLI: Can I make one more --
MS. MULKEY: Sure.
MS. SPAGNOLI: I just -- I guess we didn't officially
say it as a possible topic for the next meeting. But I think
this idea of, you know, improvements in agricultural product
is a topic that could be considered for the next
MS. MULKEY: And again, there will be opportunities
through the e-forum -- one of the things I'm going to commit
to is to log on myself and pose some -- chair a day or two
a little bit in an effort to try to add a little bit to that
process, which Margie, of course, keeps me posted and focuses
me. It's not like I'm not paying attention. But I'll try to
log on. Get with the new century.
Okay. Thank you guys again. Thanks to all of you, especially
you stalwarts who are still here to be thanked in person.
MALE SPEAKER: That's right.
MS. MULKEY: And by the way, I think that dining room
probably is a little lighter now, so if anybody has got time.
(Whereupon, the meeting was concluded.)
- - - - -
CERTIFICATE OF TRANSCRIPTIONIST
I, J. K. Tennyson, do hereby certify that the foregoing transcription
was reduced to typewriting via audiotapes provided to me;
that I am neither counsel for, related to, nor employed by
any of the parties to the action in which these proceedings
were transcribed; that I am not a relative or employee of
any attorney or counsel employed by the parties hereto, nor
financially or otherwise interested in the outcome of the
J. K. TENNYSON, Transcriptionist