The Food Quality Protection Act
Proceedings of the Conference
March 3, 1999
Westford, Massachusetts
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EPA
Region 1, New England
Food Quality Protection Act
Proceedings of the Conference
March 3 rd, 1999
Westford, Massachusetts
Table of Contents
Introduction
Summaries of Talks
Appendix I
Briefing on Endocrine Disruptors
Briefing on Access to Pesticide Information
Appendix II
Slides for David Miller's Briefing
Appendix III
Slides for Evelyn Washington's Briefing
Appendix IV
Speaker Bios
Appendix V
Conference Evaluations
Appendix VI
Dr. Goldman's Q&A
Appendix VII
Attendee List
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Proceedings of the Conference
Food Quality Protection Act
Organized by the Pesticides Section, Region I,
United States Environmental Protection Agency
Sponsored by:
EPA Region I
New England State Cooperative Extension Systems
New England State Pesticide Departments
At
Westford, Massachusetts
March 3rd, 1999
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Introduction
The conference was initiated by Region I of the Environmental Protection Agency to get
information to, and feedback from, New England stakeholders on implementation of the Food
Quality Protection Act of 1996. The conference was preceded by an April, 1998 meeting on the
Food Quality Protection Act between Dr. Lynn Goldman, EPA Assistant Administrator for
Prevention, Pesticides, and Toxic Substances and a group of New England stakeholders. (See
Appendix 6) The issues raised at that meeting made it evident that a conference on FQPA would
be useful to a wider New England audience.
Eighty representatives from commodity groups, food producers, government agencies,
academia, state agencies and public interest groups attended the conference which was held
March 3,1999 at the Westford Regency Hotel and Conference Center in Westford, MA.
Mindy Lubber, Deputy Regional Administrator, provided the keynote speech.
Conference talks and panel discussions covered governmental efforts to both implement and
spread the word on the Food Quality Protection Act: the current status of EPA's implementation
of the Act, EPA's data needs and its risk assessment process, EPA headquarters and Regional
activities in spreading the word on FQPA, FDA's program to monitor pesticide residues on food,
and the impact of the Act on drinking water. Discussion sessions were held on EPA's outreach
efforts, the "risk cup", endocrine disruptors, and data requirements.
Rob Koethe and Andy Triolo shared moderator duties during the morning session.
These proceedings include edited transcripts of the talks and panel member discussions. A
summary of the break-out discussion on endocrine disruptors as well as on the outreach
discussion are included. In appendices a summary of the discussion between Dr. Goldman and a
group of 30 stakeholders is provided. Biographies of the speakers and panel members and a list of
attendees is also included.
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EPA Food Quality Protection Act Conference
Summaries of Talks
Introduction
Robert Koethe, Moderator
Hello. I'm Rob Koethe and I'm the EPA-New England pesticide expert. I want to welcome you to
our conference. We at EPA-New England, together with our co-sponsors, the University of
Massachusetts Extension System, Massachusetts Department of Food and Agriculture, as well as the
pesticide regulatory agencies and extension services from all the other New England states, are
holding this conference to improve your understanding of the new food safety law, the Food Quality
Protection Act.
I would like to give special thanks to Natalia Clifton and the University of Massachusetts Pesticide
Education program for handling the conference registrations.
While we've been planning this conference for a long time, it turns out that the conference is
incredibly timely since articles and issues relating to pesticide residues in food have been in the news a
lot over the last few weeks. The main objective of this conference is to inform you about pesticide
and food issues within the framework of the Food Quality Protection Act. We will also provide you
with an opportunity to speak with professionals in the EPA pesticide program who are responsible for
implementing the changes required by the Act.
We have about 80 people here representing a wide range of perspectives, including pesticide
regulatory agencies, university extension specialists, and other university staff; we also have Public
Health Department people, environmental interest groups and members of the general public
attending. I think the exposition of our audience is unusual and I think we'll have some interesting
questions and discussion during the session.
Turning to the agenda which is in your packet, we do have a last-minute change. One of our
speakers, Dr. Chris DiFonzo of Michigan State University, had airline problems and won't be here;
however, LeBelle Hicks of the Maine Board of Pesticide Control, has graciously volunteered to lead
Chris' break-out session on endocrine disruptors.
Today's program is structured to go from the big picture to special topics. We'll start with two
speakers who have key responsibilities relative to the Food Quality Protection Act at EPA
headquarters. Then we'll have a group of panelists who represent federal agencies, who will discuss
their perspectives and responsibilities relative to the Act. In the afternoon we split up into concurrent
sessions in which four topics will be covered. Three of them will be repeated twice; the endocrine
disruptor session will only be run once. Later in the program just before lunch we'll announce the
specific room assignments for the break out sessions.
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Now I'd like to introduce Mindy Lubber, our keynote speaker. Mindy is the Deputy Regional
Administrator for EPA-Region I, New England. Mindy is responsible for the administration and
management of the 800-person, $450 million budget office as well as for overseeing the
programmatic policy and legal work of the region. She personally directs the region's external affairs
programs, which includes media relations and intergovernmental aflairs. She's a member of the
Region I senior management council. In the past she served as president of Green Century Capital
Management, an investment firm dedicated to investing in environmentally responsible companies
which donates all of its net revenues to supporting environmental advocacy. Mindy was a senior
advisor to former Massachusetts Governor Michael Dukakis and was part of the team that ran his
presidential campaign. She's held various positions with the Massachusetts Public Interest Research
Group including Chairwoman of the Board of Directors and Legislative Directors. Mindy holds a
bachelor's and master's in business administration and a law degree. She's a member of the
Massachusetts Bar. Mindy, will you please come up and address us?
Keynote Address
Mindy Lubber, Deputy Regional Administrator
Good morning. Thanks for being here. I'm certainly glad to be here. It is a terrific topic to be talking
about. My comments will be brief. I want to offer some introductory comments on the day, the Act,
and how this ties in with the rest of the mission of the Environmental Protection Agency. But today's
conference, and more importantly perhaps, the Food Quality Protection Act itself, is truly an exciting
piece of business to be talking about, and an exciting place for us to be going with all of you in terms
of how we implement it. And it could not be a more compelling subject.
There's often this issue, and we ran into it in spades during the Congressional attacks when our
budgets were being reduced three or four years ago, people often said, I can't get my hands around
what you do. How does it relate to my daily life? You talk about pollution prevention; I can't figure
out what that means. Enforcement of certain polluters I understand but I don't necessarily see the
connection.
I always use the Eleanor Lubber test, Eleanor being my mother; a middle-of-the-road, educated
person. She certainly doesn't know all the intimate details of the Agency. If she gets it and thinks it's
important, it means we're communicating to the rest of the world; to the average citizens who very
definitely care about the environment, who could not care more about their children's health and
safety. When you talk about protecting the food their children are eating, it is the kind of subject
matter that resonates, that will allow us to involve the public in an even greater way in the work that
we do, and I believe that involvement always makes for richer, smarter and more compelling
decisions.
So for any number of reasons, I am pleased that we are getting more and more and engaged in the
Food Quality Protection Act through this conference and obviously in other ways as we implement it.
It's also a very timely conference. I am a friend of newspapers and try to read two or three a day, as
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well as something in the office we call the Green Wire which gives us capsules of the highlighted
news stories all across the country. It is clear to me that food safety-related issues have been in the
news for the last month or two on an almost daily basis, in headlines from Los Angeles to Mississippi
to Texas to Utah to Ohio to New York. We are seeing news stories, good and bad, about what's
going on with food quality, with the pesticides on food and so on. It is on the public agenda and that
is a good time to be tackling an issue, when it's on the public agenda.
Less than a month ago EPA released its right-to-know brochure on pesticides and food. Obviously,
that was mandated by the Act, but it was also a very wise thing. We mailed it out to more than
30,000 grocery stores across the country, and if ever there was an act that was consistent with what
the philosophy of this administration of the Environmental Protection Agency is, that is the public's
right to know. We have, over the last four or five years, reached out to the public on every major
issue we're tackling.
We realize that none of these laws can be implemented without partnerships with people like each and
every one of you in the room, partnerships with the general public. We have not reached Nirvana, but
we have gotten better at involving the public in one issue after the next, in assuring that stakeholders,
people who have an impact from the industry side to the state government side and local government
to the environmental community side, that they are involved in our decisions, in our regulations, in
our practices and, again, I believe we are a smarter and more thoughtful agency because of those
partnerships and that involvement. The community right-to-know spirit of this administration has
moved us further in taking on our responsibilities and carrying them out well.
I think this Act is a perfect example of an Act that will not be successfully implemented without the
involvement of partners from state government, to local government, food agencies, agricultural
agencies, chemical companies, and environmental groups. Today is a very big part of bringing
thoughtful, key stakeholders into the process and making sure we're looking at some of these issues
together and proceeding in a way that makes sense. So with this Act we continue one of the most
admirable things of this administration, and that is involving the public; community right-to-know
pieces, and 30,000 grocery stores hopefully are now helping move that new information out to the
public.
Pesticide concerns that have been in the news recently are striking at everybody. As we reach the
tenth anniversary of the Alar apple crisis, Consumer's Union and the Environmental Working Group
have both recently published their concerns about pesticide residues on fresh fruits and vegetables.
We may feel things have gotten better; they're not as convinced and we've got to work with them to
make sure that we share their concerns about ensuring the safety of our children's food. We share
every bit of their concern. It is our job to regulate pesticide use so that everyone's food is safe and
we're going to work with them.
A year from now or two years from now, we hope to be seeing fewer scathing attacks on the
pesticides that are out there on our food, and more cooperative relationships on how to regulate
them, and how to do it in a way that works for all parties.
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In almost every speech I've given since I've joined the Environmental Protection agency, and that's
three years or so, there's almost always a reason to refer to my children. They're on my mind all the
time, as is the case with any parent, and I could think of nothing that is more important to me than to
make sure that food I'm putting on the table is safe. I'm fairly tough on my kids to keep up their
quota of five fruits and vegetables a day. We all read about five fruits and vegetables a day; it's
important to start them young. I've got a four year-old daughter and an eight-and-a-half year-old son
and they know the drill is, five fruits and vegetables a day, one way or the other, even if it's three
small oranges at 8:00 at night.
It doesn't help when there are mitigating articles that we're all reading that say, don't have your kids
eating strawberries; or blueberries are toxic. Not everybody should be forced to go to very high-
priced, Bread and Circus-kind of stores, a perfectly lovely store in my neighborhood where I can
scream to my husband, make sure you buy organic vegetables and fruits for the kids. We shouldn't
have to do that. Every parent, every person, should be able to have the confidence and the certainty,
when they are forcing their kids to eat those five fruits and vegetables a day, that those fruits and
vegetables are going to be safe. I could not be more passionate about that. I'm sure each and every
person in this room cannot be more passionate about it and the public cannot be more passionate
about it.
It is our job to get it right, to figure out how to do it, which I'll talk about briefly, and some far-
smarter scientists and experts will talk about it following me. It's not going to be easy. The science
in doing this is complicated. People think that these answers come easily overnight. Tomorrow we're
going to make everything safe for everybody who's putting fruits and vegetables and other food on
the table for their families. It's not that easy. On the other hand, it is important and I am convinced
that we're going to find a way to deal with it and make sure that dangerous levels of pesticides are not
on our tables. We now have to figure out how to make sure we get there efficiently, expeditiously,
with as much involvement of all stakeholders as possible.
But it is clearly why I'm particularly glad to see the Food Quality Protection Act, to see that it was
passed unanimously by the Congress in 1996. It brings with extra clout the support I think it's going
to take, that we're going to need to move it forward. It represents a big step forward in how we are
required to regulate pesticides. It will make a difference in people's everyday lives. They will
understand it, they will get it, they'll not sit and wonder about all this stuff the Environmental
Protection Agency does. But as I said, it's a very big challenge for us scientifically. This stuff is not
easy. I don't need to tell you that. You're living it; you implement and work on complicated scientific
issues every day.
Let me note some of the main points of the Food Quality Protection Act. Pesticide residues are now
regulated by a single standard for both raw and processed foods. EPA is required to weigh all routes
of exposure to a pesticide, both the aggregate risk and multi-media, not just the exposure from one
particular use. In addition, if groups of chemicals are thought to act by a common mechanism of
toxicity, the risk must be weighed across the entire spectrum, the cumulative risk. We are not only
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looking at separate pieces. The Act also demands special protection for children, including an extra
ten-fold safety factor in some cases, and it calls for a new screening program for endocrine-disrupting
effects. We'll talk more about all of those things today.
These changes are clearly a big step forward for the safety of our food supply. At the same time, they
create major challenges for us at the Agency, for other regulatory agencies, for pesticide experts and
users, and public interest groups. Today I hope we start taking on those challenges, to learn about
current issues related to our new pesticide law. Not that EPA's pesticide stewardship programs are
solely centered on the Food Quality Protection Act. Let me at least note for context some of the
other things that we're doing and I think carrying out well in the Agency. For instance, the Agency
expects to finalize its pesticide and groundwater rule to assure that groundwater resources are
protected from pesticide contamination. We are working on this area throughout our program
offices. EPA has also established a pesticide urban initiative to address problems of misuse of
pesticides within urban communities. I want to note that we unquestionably have taken the urban
environmental problems, and moved them up as high priorities, given the vast amounts of pollution,
the amounts of pesticide problems that exist in our urban communities. Another mark of what I
believe is a philosophical change all in the absolutely right direction.
The EPA has established a Biopesticides and Pollution Prevention Division dedicated to reducing the
use and risk of pesticide products. The EPA-New England Office's Pesticide Environmental
Stewardship Regional Grant program, supports research on sensibly reducing pesticide use in New
England. Through the Massachusetts Integrated Pest Management "Partners with Nature" IPM
Certification program, homeowner pesticide education programs in Vermont, and research into
alternative methods of controlling blueberry maggots in Maine are going forward and are prospering
because of money we've been able to bring to those states.
There's a lot of information to throw at you today and as the day goes on you'll be getting more and
more thrown at you. I want to make sure that we all learn today. Let me just take one more minute
and boil down some of the bottom-line themes of EPA's pesticide programs because they are themes
that I think form the basis for all of our work here today as well as all of our work at EPA New
England. One is a real focus on the most vulnerable sections of our populations, whether it is children
exposed to pesticides, asthmatics exposed to air pollution, or elderly and others with compromised
immune systems exposed to poor quality drinking water. EPA is committed to extending to all
people the right to not be exposed to dangerous levels of pollution.
We are making special efforts to reach out to those communities of people who have not gotten
enough of what they need to bring them back into society in a way that's comfortable so that they're
not suffering special ills. We haven't fixed those problems. Asthma's still rising. But we are
dedicated to making a better effort and taking greater steps to deal with vulnerable sections of our
population. Another theme is a growing methodology of not examining pollution problems, pollutant
by pollutant or media by media, but instead looking at the whole of the problem. That is happening
with pesticides through the Food Quality Protection Act and for other pollutants through EPA's
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multi-media approach. The problems aren't only in the water or just in the air or solid waste; they're
cumulative.
We can no longer afford to look at these things on a piecemeal approach and we're not, and I think
we will get to far better and smarter solutions for the problems because of that approach. This
approach, though, requires a renewed emphasis on strong science for good decision making. EPA is
constantly struggling to improve the scientific basis for our decisions to ensure that we really are
doing everything we need to do to protect ourselves. We don't want to study things to death. We
don't want there to be ten-year studies on every chemical. On the other hand, this is complicated
stuff. People will be fighting us every step of the way. Our science need to be strong, needs to be
good, and we're going to make sure we do that. And right along with this holistic approach comes an
emphasis on pollution prevention rather than cleaning up after the fact.
Looking for ways to use less toxic chemicals in manufacturing is really the only way to go, and to use
fewer pesticides in growing our food. We've seen tremendous reductions in toxic use emissions and
we expect to see this trend continue. It doesn't happen accidentally. It takes partnerships, it takes
aggressive programs, it takes resources from the federal government. We are aggressively trying to
bring as many of those resources into the region as possible to share with all of you and we will keep
working at it.
And the final theme that I see happening at EPA is a commitment to increased cooperation between
EPA, the regulated community, environmentalists and the public. And once again, that is why we're
here today, to cooperate with each other, to learn from each other, to work together to make the
regulation and use of pesticides in this country more successful.
Let me say one more thing, and that is these laws, the laws that we have all worked on collectively,
whether they're the Safe Drinking Water Act, the Superfund laws, the air pollution laws that we are
acting under, they have made a difference. It has been a long struggle. It has been 20 years in some
cases, two or three years in other cases, but let me just cite one or two facts that are heartening to
me.
In the days when we are pushing through two years of study on one small issue, to really step back
and think that collectively we have made an enormous difference, not only in the environment, but in
people's lives, and I believe this Act gives us another ideal opportunity to continue that kind of string
of success. Because of the Safe Drinking Water Amendments of 1996,1 believe, 86% of the
American population will receive drinking water that meets all health-based standards in effect since
1994. The quality of the drinking water has been brought up enormously. 585 Superfund toxic waste
sites have been cleaned up as of the end of 1998, and an additional 85 construction completions will
occur in 1999. 227 communities have benefited from grants to revitalize urban brownfields,
leveraging over $ 1 billion in private investments. Thanks to the passage of the Clean Air Act,
approximately 164 million Americans are breathing cleaner air today. I could go on and on. My key
point is, this stuff works. We passed these laws. When we get to the business of implementing them
with partnerships, with lots of thought, with good science, and going at it the way we did with a
number of the other things I've just mentioned, we will meet with success. I look forward to the
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work of today that's getting us to the next step in our work here in the region in implementing this
law and to continuing to work with you on a regular basis for the future. Thanks very much and have
a good day.
Koethe
Thank you, Mindy, for helping put this meeting in the context of EPA priorities. Our first speaker to
discuss implementation of the Food Quality Protection Act is Jim Jones. Jim is currently Director of
the Registration Division in the Office of Pesticide Programs (OPP). Prior to that he served briefly as
an Associate Director of the Field and External Affairs Division in the Office of Pesticide Programs,
and as Chief of the Registration Support branch in OPP. Jim's been with EPA for 11 years. He has a
master's degree in economics from the University of California at Santa Barbara and a bachelor's in
economics from the University of Maryland at College Park. Jim will provide an update of the Food
Quality Protection Act.
Implementation of FQPA From A Tolerance Reassessment and Registration Perspective
James Jones
Good morning. It's good to be here in New England. I actually don't get up here professionally too
often as the Director of the Registration Division; however, I hail somewhat from this region. I grew
up in Albany, New York and I have family all throughout Massachusetts ~ New Hampshire as well.
So I get up here personally quite a bit. Not too much on business, although I have been waiting quite
some time for Jerry Downing to invite me to some of his cranberry bogs. Maybe this will be the
opportunity to get such an invitation.
This morning I'm going to give a broad overview about how we at EPA and the Pesticide Program
are implementing the Food Quality Protection Act, both from a tolerance reassessment perspective
and a registration perspective. Mindy gave us a nice overview of what the Act did in terms of
changing our statutory requirements in the pesticides program. That includes going to a risk-only
standard, and a requirement that we add aggregate risks across all sources of pesticides exposure as
well as accumulated risks where the pesticides share a common mechanism of toxicity. That new
standard needs to be applied to both old pesticides that's the program that the statute refers to as
tolerance reassessment; that is, tolerances that were on the books before the law passed in August of
1996. The law also requires that the new standard be applied to all new pesticides, both new active
ingredients for registration as well as new uses of old active ingredients. That latter part, registration,
is the area that I work in. However, I'm going to cover both areas here this morning
The tolerance reassessment program, which requires all existing pesticide residue tolerances, all 9,000
tolerances that were on the books at the date of passage of the Act, be reassessed against the new
safety standard in a 10 year period. The first third of those need to be reassessed by August 3, 1999,
a few short months from now. The EPA is confident that we will meet the goal of reassessing one
third of the tolerances that were on the books when the statute passed. We've reassessed about 2,300
now and we think we'll have another 1,000 done before August 3rd.
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Soon after the law passed, the Agency established a Tolerance Reassessment Advisory Committee. It
was clear from the get-go that there was going to be a lot of controversy involved in implementing
the statute, in particular the tolerance reassessment aspects of the statute. The EPA senior
management, and I'm referring to the Administrator level, as well as the USDA senior management
level, the Secretary's office, decided that we should have an advisory board which is composed of
about 45 stakeholders. It includes a very wide and diverse group of individuals representing growers,
manufacturers, public interest community, states and others, and has been meeting over the last year
and a half. Its purpose is to give the Agency advice about how to go through the reassessment
process, focusing largely on the organophosphates which is one of the biggest classes of pesticides
that well be looking at and one of the more controversial ones.
I think the Agency feels that we have gotten two fundamentally solid pieces of advice that we have
acted on where we felt the Advisory Committee was telling us something that we really needed to do.
Ill spend a little time talking about those two things that we have begun to do. Some of them are
pretty far along. They both have to do with some of the things that Mindy was referring to earlier.
Basically, having a process that's much more transparent. Having more stakeholder involvement in
our process, which in the pesticide program frankly has not been our strength.
We may be one of the later programs to have gotten on board with some of the right-to-know issues
that the Administration has been focusing on over the last several years. But the TRAC, the
Tolerance Reassessment Advisory Committee, suggested there were two areas which we really
needed to cover. One was that there were clearly major science policy issues that we're going to need
to meet before we can go forward with any reassessment. I'll touch a little on some of those this
morning. And secondly, they recommended we have a far more public process for announcing the
risk assessments that we complete.
We have had some experience with making public our risk assessments in the Pesticides Program but
historically we have not had a very public process for the outcome of that, the regulatory management
that comes at the end of that. If it's not acceptable, what uses are we going to mitigate or potentially
drop to get the risk to where it needs to be to meet the standard? So, we have both those
recommendations we have followed through with.
We've identified a total of 19 science policy issues, and the TRAC was very active in identifying these
19. It started out as nine and as people kept thinking about them and talking about them, more got
added and we've gotten to 19 right now and I'm not saying that we're not going to have any more, but
right now there have been 19 identified. On all of these 19 we have issued, or we will soon issue,
Federal Register Notices. We've been posting our interim operating policy on them on our web site.
And we're taking public comment on our policy. After we have considered the public comments, we
will issue a final policy.
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Some of these issues are going to be very familiar to many of you, as we've been talking about them
since the day the law was passed. Verse one is, how will EPA implement the extra ten times safety
factor for infants and children? That's one that's gotten a lot of attention over the last several years.
Another one that we've heard a lot from the users about is, how does EPA interpret the risk when
there are no detectable residues on a crop where there's been monitoring involved? EPA has
historically used half the limit of detection, or half the limit of quantification for that. There's been a
lot of criticism of that policy, so we have issued a notice that identifies how we're actually going to be
doing it, and we're taking public comment on that.
How will EPA calculate drinking water exposures? We've got to aggregate exposures across all
sources. You can be exposed to pesticides through your food, you can be exposed in your home, you
can be exposed at school, and you can be exposed through drinking water. OPP did not assess
aggregate drinking water risks prior to FQPA; it's very new for us. We have been working on it for
the last three years. We have struggled with it, and we have now published a notice that describes
how we're doing it, and we're taking public comment on that.
Another one that's just specific to the organophosphates (OP's) is, what is the appropriate
toxicological end-point for assessing the OP's? There has been a lot of controversy about that it's
an issue that we've taken to our Science Advisory Board three or four times over the last five years.
Some people say you should only be looking at cholinesterase inhibition in the brain; some say it is in
the blood, that's what's biologically important; others say it's in the plasma. We've currently taken a
weight of the evidence approach, and that's what's in our current policy.
Another area we're taking public comment on is, when does a food use not require a tolerance? To
give you an example, you can be applying a pesticide to a fruit tree during dormancy. That would
seem to be a food use, you're applying a pesticide on a tree that bears food. However, it is certainly
possible that there will be no residues on the fruit. We have historically established tolerances for
those situations, and this policy describes a proposal for not even having a tolerance for such a
situation as that.
Another one that's been veiy controversial is, what's the appropriate percentile of acute dietary
exposure at which EPA should be regulating? Since prior to FQPA, we have very refined data that
has been used in a probabilistic risk assessment, also known as Monte Carlo. We have regulated at
the 99.9th percentile of exposure, which to some seems like we're over-regulating, and to others it
seems like we're under-regulating. If you're talking about a population of several hundred million,
which we are, that 99.9th percentile, leaves a rather large theoretical number of people above that
level. It's been very controversial, so we've decided we would take public comment on that. This is
one of the science policy issues we have not yet released for comment. I think that one's going to be
issued in the next 30 days.
The last one that I'll briefly mention, I'm only mentioning about 10 of these as opposed to the whole
list of 19, is how should EPA use Pesticide Data Program data? This is the data the USD A collects;
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it's monitoring data. It's a program that was created several years ago, whereby the USDA goes out
into commercial warehouses, collects samples of food items, and measures actual residues. If you're
talking about a pesticide that's got chronic concerns, we have had no problem using the Pesticide
Data Program data. One of the details of PDP is, they will take a sample of 10 bananas, and they'll
take the 10 bananas and they'll mix them all up. And if we're talking about a chronic risk, on average
an individual is being exposed to something chronically, will get basically the mush in the 10 bananas.
And that's a not inappropriate scientific judgment for us to use. But for an acute exposure, where it's
the consumption of one food item, and not a mix of five or 10 mixed together, it may be completely
invalid to use a blender mix of 10 food items, and assume that an individual is exposed to one. You
could have wide variance in what went into that mix. You could have something that had 100 parts
of per million, and the rest of them had zero parts per million, and the average therefore is going to be
10. But that's not what that person ate who had the banana with 100 parts per million on it. And so,
we've been struggling with it and we think we've come up with a creative solution for how we can use
PDP data for acute dietary exposure and we're articulating that in a notice which is going to be issued
in April of this year. We haven't completely dismissed PDP data for acute dietary exposure, which is
very important for the OP's and the end-point is acute risk. We have come up with somewhat of a
solution for how we can use that data.
Those are 11 or so of the science policy issues that we have or are about to issue notices on asking
for public comment. They're available on the Internet. Many of the people here from EPA could
direct you on how to get access to those if you haven't already.
One of the things we're struggling with is that we've gone to such a degree of transparency and there
is so much for people to participate in, that groups, even organized trade groups or public interest
groups, let alone individuals, are having a hard time handling the volume of information. At the same
time we feel that we need to move forward to meet some of the statutory time frames.
Those science policy issues, with the exception of one or two, are very generic science policy issues,
and the way in which they are resolved over the next several months will likely apply to all tolerance
reassessments, not just the OP's, as well as to registration activities.
I'm going to talk briefly now about where we are with respect to the OP's. The organophosphates
were identified as one of the high priority classes of chemicals that the Agency would review first in
its tolerance reassessment efforts. Although it is unlikely we will have reassessed all of the OP's by
the August 3, 1999 deadline, we will meet that deadline, and there will be many OP's that will be
included in that deadline, including about nine of them which have already been voluntarily cancelled.
Most of the nine that have been voluntarily cancelled had very few food uses though. Again, we're
trying to have a very open, transparent process for our work on the organophosphates.
We've developed a six-phase process that has multiple opportunities for public participation. The six
phases are as follows: In the first phase, the registrant, the manufacturer of that particular
organophosphate and the Department of Agriculture get 30 days to correct any errors that they may
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think are in our preliminary risk assessment. Currently we have 10 OP's that are just about ready for
phase one.
In phase two, EPA considers comments that USDA and the manufacturers have made; there are
currently two OP's in that phase.
In phase three, the preliminary risk assessment is made available to the public through the Federal
Register as well as through our Internet site. 13 OP's are currently in phase three, their preliminary
risk assessments are available for public comment, and the comment periods have not closed yet. We
are generally providing 60 days of public comment on our preliminary risk assessments.
In phase four, EPA refines its risk assessment and David Miller, who will be speaking after me, will
be talking this morning, about what is entailed in defining our risk assessment. In phase four, that's
what we do, we get in there and we refine the risk assessment, incorporating comments that we
received in the public comment process. There are currently 14 OP's in phase four, in which we are
refining our risk assessment.
In phase five, EPA releases the refined risk assessment and begins to accept comments on regulatory
management options. If the risk is acceptable for the pesticide, there may be very few relevant
regulatory options. If the risk is not acceptable for the OP, there is going to be a need for some
mitigation. It is at this stage that we're going to be asking the public to give us options for mitigating
risks. I think this will be a very relevant time for growers and manufacturers, as well as for the public
interest community. This is where changing use patterns could be considered.
We've certainly had a lot of experience in pesticide regulation where changing the use pattern can
take a pesticide that may have been used heavily at the end of the season, if used earlier in the season
can significantly change the risk attributable to that commodity. This will be where that kind of
mitigation will be considered. This is the part of the process where growers try to identify lower
benefits and higher benefits uses. Clearly, if we find ourselves in the position of dropping uses of
pesticides, which is a very likely outcome, our objective is going to be maintaining the uses with the
highest benefits and the lowest risk and dropping those with the lowest benefits and the highest risks.
That will basically be the philosophy that we use. The public's participation is very valuable. You
know, as growers, which of these compounds provide the highest benefits to you, which provide the
lowest benefits, which have alternatives, which have no alternatives, when use patterns are practical
to change; all of this will be considered.
It's very likely at that point that the EPA and USDA will actually meet with specific grower groups
and with manufacturers individually to more intensively discuss risk mitigation. For example, if one
crop seems to be accounting for 80% of the risk, the logical thing could be to work with that one
crop to see what we can do to get that risk down significantly. That may make the overall risk OK
for another 15 or 16 crops that that chemical is used on. Those meetings, however, will be docketed,
minutes will be taken and they'll be put in our public docket so that there will not be any closed-door
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sessions in which the public does not have the ability to know what kind of a deal got cut behind
closed doors.
Finally, in phase six, EPA will develop risk-management strategies and ultimately make risk-
management decisions. So that's the six-phase process that we have identified for the OP's. It's a
pilot process; if we are successful in using this process for the OP's, it will likely be considered for
other chemicals in tolerance reassessment. As I mentioned, 12 OP's are in the first period right now,
two are with USDA and the registrants to correct any errors we may have made, and on 10 we are
about to issue a preliminary risk assessment.
Now I'll talk briefly about registration basically of synthetic, not antimicrobial, pesticides, which is the
area that I work in. Registration has a critical role in the tolerance reassessment process. To the
extent that the Agency is removing pesticide uses or pesticides from the market, the availability of
alternatives becomes even more critical than it was in the past, so we have taken some steps to
acknowledge our importance in that process.
Last year we registered 13 new conventional active ingredients and 73 conventional new pesticide
uses. This year we plan to register 13 new active ingredients and another 75 new uses. Although
we're at about the mid-point in our fiscal year, and for the first time since I've been managing a
production-oriented regulatory program in OPP, at mid-year we're actually revising our estimates
upward. We think we may be able to register 15 new active ingredients and upwards of 100 new uses
this year.
We've made reduced-risk pesticides our top priority. Last spring we made the registration of OP
alternatives another very high priority, right up there with reduced-risk pesticides ~ and methyl
bromide alternatives, of which we have not seen very many. This year we expect to register six
organophosphate alternatives. For the first time, we are going to be publishing our annual plan of
work for new chemicals and new uses, somewhat of a controversial action on our part that wasn't
widely embraced at the beginning. Actually, growers have always thought this was a great idea. The
work plan was just signed, and will be in the Federal Register and on our web page next week. The
work plan identifies all the new chemicals that are proposed for registration, the crops they'll be
registered on, the manufacturer, and the time of year in which we plan to make the registration
decision, as well as any special characteristics, such as, is it an OP alternative or is it a reduced risk
pesticide? We hope that by doing so, we will allow the users to have greater access to what's going
on in the registration program. Researchers are finding this very useful as they can identify
compounds that may not have been proposed for the crop that they are interested in for registration,
but knowing about it, they can do things to affect that. They can work with the registrant, they can
work with IR4. We have had growers who have felt that if they had access to what was coming
down the pipeline, they'd be in a much better position to be aggressive with manufacturers and with
EPA about pursuing new uses. I'm also looking for greater accountability on my part as well by
doing this.
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The Section 18 program is another area that I know growers are very concerned about, and I think
there is a higher degree of confidence that we've been able to turn Section 18s around in the manner
that the user community had become accustomed to prior to FQPA. Last year we averaged a 53-day
turnaround time; this year I think we're going to beat our 50-day goal, so we're very pleased with
that.
In summary, I think that we have embarked on a rather bold, new course. Not only do we have a
statute that is dramatically different that we are working very hard to implement, but we have opened
up the process in the Office of Pesticide Programs at EPA in a way more dramatic than ever before.
We're very hopeful that by having a more open and transparent process, we will not only make better
decisions, but those decisions will be better understood. Thank you.
ROBERT KOETHE: We have time for one question now. Bill?
WILLIAM COLI: Can you explain how the risk assessment process you described is going to be
completed by August, given the statement you made about the policy issues being decided upon
before the risk assessment process can even go forward?
JONES: I think that it's pretty clear that for the organophosphates, it's highly unlikely if not
impossible to complete the final risk assessments and final regulatory management before August 3,
1999. We're not even going to be issuing our final guidance on how to do the cumulative piece until
December of this year. So, although we are quite confident we will meet the statutory goal of having
30% of all tolerances reassessed by August 3, 1999, we will not complete the reassessment of all the
OP's. There are several OP tolerances that we will be able to count as completed. For example, if a
manufacturer voluntarily cancels one, we can count it. One of the other science policy areas we're
thinking about is called Early Winners. These are use patterns that pose so low a risk, that we might
as well just say we're done. They are going to stay. Those can be counted as well. So, some OP's
will be counted by August 3, but the vast majority of them will not be.
Data Needs and Risk Assessment
David Miller
Koethe:
I'd like to introduce David Miller who has been with the Health Effects Division for six years,
working as a residue chemist and risk assessor. The focus of his current work at EPA is probabilistic
risk assessments. Prior to his agency employment he was a sanitary engineer in the Peace Corps,
assigned to the Ecuadorian Ministry of Public Health. He was also an associate engineer at a health
and environmental sciences consulting firm in Arlington, Virginia. He received his bachelor's degree
from the University of Pennsylvania and master's of science and master's of public health degrees from
Virginia Tech and the University of Michigan, respectively. He's a commissioned officer in the U.S.
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Public Health Service. Mr. Miller will speak to us about data needs and risk assessments under the
Food Quality Protection Act. David.
David:
Hi. My name's David Miller. I'm a residue chemist and exposure assessor in EPA's Office of
Pesticide Programs in Washington, and I'm going to talk to you today about risk data needs and
assessment.
The next slide please. I'd like to provide an overview of the talk. I'll start with an introduction to the
Food Quality Protection Act and touch on some of the science impacts of the Act. One of the major
science impacts is aggregate exposure; I'll talk a little bit about that. Considering aggregate exposure
is a new requirement under the Act and it has had a major effect on what we do. I'll then go into the
risk equation. When the Agency says a risk exceeds or doesn't exceed a level of concern, this is the
equation we use to make that determination. It has two parts: the first part listed there is the hazard
identification and dose response part of the equation; that's in essence the toxicology part. And that
determines the size of the risk cup, if you're familiar with that terminology. The other aspect is the
exposure part; it's how much is in the risk cup. There are two parts to that: one is the residue
chemistry part, how much is in the food; and the other is food consumption, how much of that food
you eat. With that as a background, I'll talk a little bit about the DEEM software; DEEM stands for
Dietary Exposure Evaluation Model, and that's what we use to perform our risk assessments. The
output is, in essence, a risk. It's not necessarily our best estimate of the risk; we can always go back
and refine it, and produce better risks if we get better information. That will close out my morning
discussion. Then this afternoon, in the breakout groups I'll talk about these additional two topics: the
tiered approach to risk assessment when we refine our risk assessment we have a tiered approach,
starting with the worst case and going to more and more refined estimates; and then, finally, risk
refinement ~ that will include some options for the kinds of data that we'd like to see, or believe
could help our risk assessment process.
The next slide. This is a brief overview of the Food Quality Protection Act; it amends FIFRA and
FFDCA, the two federal laws that are concerned with pesticide residues in food and pesticide uses. It
was enacted into law August 3rd, 1996. It was in force immediately, which meant we had to hit the
ground running; there was no lead time or preparation time, and everything we did as of that'date had
to comply with all the requirements of the Act. Another thing that was mentioned before is it requires
that 9,000 tolerances be reassessed over the next 10 years.
Next slide. Here is a list of some of the major science impacts of the Act. Some of them have been
mentioned before. I'll just briefly go over them. One is the additional ten-fold safety factor to
account for the special sensitivity of infants and children. The second is the development of testing
and screening methodologies for endocrine disrupters, which is scheduled to be discussed this
afternoon. There's also aggregate exposure; the EPA under FQPA is required to aggregate exposures
across pathways. Before FQPA, we looked at food alone and residential exposure alone; we didn't
combine the two. Now, we have to look at food, we have to look at water and we have to look at
residential; and also look for the potential co-occurrence of these exposures. Before it was separate,
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and now we have to consider them, in addition to separately, but together as well. Finally there's the
requirement under the Act that we do cumulative exposure across chemicals. So, if chemicals have a
similar mechanism of toxicity, before FQPA we were doing one chemical at a time; now if there are
similar mechanisms of toxicity we'll have to combine those risk assessments. In the illustration in the
next slide is a chart summarizing the aggregate exposure and the kinds of pathway exposures we look
at. Pre-FQPA, we looked at dietary or food separately from residential, separately from water. They
weren't combined. Prior to FQPA, we did not generally look at drinking water except under special
circumstances. Post-FQPA, we're required to continue to look at drinking water, residential and
occupational separately. We're required to add in drinking water and we're also required to combine,
in an aggregate exposure, drinking water, food and residential exposures. Taking into account
potential co-occurrences ~ you can be exposed on the same day to food with pesticide residues, to
water, and use pesticides in your home, for example. The talk will concentrate on the food portion of
the assessment, but remember that well have to do the aggregate with drinking water and residential
exposure as well.
This next slide shows the risk equation; in other words, how do we calculate that the risk of pesticide
X is unacceptable, but the risk for pesticide Y is acceptable. We use the risk equation to do that. It's
equal to exposure divided by hazard. The hazard part is the toxicology part of the assessment and
consists of a reference dose. I'll talk more about the reference dose in a minute, but in essence it's the
maximum safe dose that one should be exposed to, expressed in milligrams of pesticide per kilogram
of body weight per day. The exposure part is the second part of the risk equation. It consists of
pesticide residues in food and food consumption.
In the next slide I give a specific example of how the calculation is done. Risk is expressed as a
percent of the RFD, or percent of the safe dose. It's equal to the exposure divided by the reference
dose. The reference dose is determined from toxicological studies which I'll go into in a little bit. The
reference dose is essentially the size of the risk cup. The exposure is how much is in the risk cup and
the risk, as a percent of the RFD, or percent of the safe dose, is how full the risk cup is. For example,
if the exposure was five and the RFD was 10, you'd say the risk cup was half full, or 50% of the RFD
was occupied. If the exposure, on the other hand, was 10, the safe dose and the RFD was 5, you
could say the risk cup was overflowing, or 200% of the RFD had been occupied. Remember that
exposure is calculated from two things; it's calculated from pesticide residues and from food
consumption together. And the RFD is determined from toxicology studies.
Next slide. Now that we have the basic equation, it's applied to two different kinds of risk
assessments. The first is chronic, which is long-term exposure; and acute, which is short-term
exposure. Long-term exposure is generally considered over a year to a lifetime. For those risk
assessments we use average residues and average consumption. The acute is short-term, generally a
day, a spike for example. For acute exposure, we use either high-end residues if the risk assessment
is less refined, or we use probabilistic methods if it ends up being more refined. That's the entire
range of residues used. On the next slide I'll go into some of the specifics of the risk equation. It's
the hazard identification dose response; it's the toxicology part of the risk equation. And again, this
measures the size of the risk cup. We use toxicology studies.
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Next slide. We use a number of toxicology studies done on laboratory animals to determine the size
of the risk cup; that's the acute RFD, the maximum safe dose. The toxicology studies are used to
determine toxicity endpoints and their associated doses. What's done in the laboratory studies is a
series of doses. For the acute, a series of single doses is given to the animals, maybe on 50 animals,
five different doses. And the toxicity endpoint is looked for. In this case, for acute it might be the
inhibition of an important enzyme. The associated dose with that in this case might be .4 milligrams
per kilogram of body weight. That would be called the lowest observed effect level. To determine
chronic toxicity, it's a similar kind of study, except instead of a single dose it's giving repeated doses
over the course of several years or the lifetime of a rat. Toxicity endpoint would generally be
something different. In this case it might be the proliferation of liver cells and the associated dose that
causes that. The lowest dose that that effect is seen at might be for example .2 milligrams per
kilogram of body weight per day. Those endpoints and the doses associated with those endpoints are
then used to calculate the reference dose. That's the maximum safe dose you can be exposed to. We
dont use those, the .2 or the .4; those are the lowest effect level. We go down to the no-observed
effect level, which is one level lower. It may be the range that was given in the dosages was from. 1
to 1 part per million; the lowest dose where an effect was seen was maybe .4; you'd go down to the
next lower one, and that would be the no-observed adverse effect level. And then you'd divide that
by the applied safety factor; generally they range from 100 to 1,000. In this case, if the dose at which
an effect was seen was .4, the next lowest dose at which no effect was seen was .2; that would be the
no-observed effect level. We divide that by a factor, generally 100 to 1,000, and in this case .002
milligrams per kilogram body weight would be the RFD. That is what we determined to be the
maximum safe dose, and that is the size, of the risk cup. Every use, every exposure then, has to be
added to the risk cup and has to fit into that. The exposure is not allowed to exceed that level. On
the next slide I talk about the required toxicity studies. This is a list of the various studies we require.
There is acute and chronic, and sub-chronic in there as well. These are the kinds of information that
are submitted to the Agency by the registrants that we review and use to determine what the safe
doses are; the reference dose or the size of the risk cup.
Next slide. Once you know the size of the risk cup, the next question is, how much is in the risk cup?
There are two factors: one is the pesticide residue or pesticide concentration in the food that's eaten.
And the other is how much food is eaten. Together those determine how much pesticide you're
exposed to. In these next couple of slides I'll cover how the Agency decides how much pesticide
residue is in the food we eat. That's the residue chemistry part, which is shown here. Generally, there
are two key residue chemistiy considerations which we look at, and which the registrants submit data
on. The two key questions are: what chemical is there, and how much is there? The what is there is
determined by the nature of the residue study, also termed a metabolism study; that's done with both
plants and animals. It determines essentially what compounds are there that we have toxicological
concern for. You may, for example, apply pesticide X. It may have breakdown product Y; it's quite
conceivable that the breakdown product is just as toxic or more toxic than the parent chemical.
These methods essentially indicate what chemicals are there that are of concern. The purpose of
these studies is to identify what's there, not necessarily quantify what's there. The how much is there,
the quantification of what's there is done in a separate kind of study; again, these are done by the
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registrants and submitted to the Agency for review. Those are called magnitude of the residue
studies. There are two kinds: one is done with plants, and those are the crop field trials that the
registrants perform; the other is done with animals, for meat and milk, for example, and those are
termed animal feeding studies. I'll just go through the plant example here. This answers the "how
much is there?" question. These are the steps, the criteria that we would use in evaluating a study.
The manufacturer is required to apply the pesticide at the maximum label rate and harvest at the
minimum post-harvest interval. The main purpose of these crop field trials is to determine how much
pesticide residue potentially could be there. We know typical rates are a lot lower; we know typical
post-harvest intervals are a lot higher, but the purpose of this is to determine a tolerance. The number
of trials we require depends on where the crop is grown. They range from three to about 20. Kiwi
fruit, for example, might require three trials all in California, whereas corn would require 20 field
trials throughout much of the Midwest. Trials have to be geographically representative of where the
crop is grown as well. For example, if 60% of the potatoes are grown in the Pacific Northwest, that's
where 60% of the field trials would have to be done. And finally, the crops are analyzed by the
registrant for compounds of toxicological concern. It's not necessarily only the pesticide chemical;
we may have identified breakdown products which are of toxicological concern that would have to be
analyzed as well. So that's where the "what" is. Part of the question is answered by the metabolism
study.
Next slide. The second part of that is determining the exposure; that is, how much is in risk cup? It
is consumption data; so consumption data times the concentration would give you the exposure data.
This is the second half of the risk equation how much food is consumed? The consumption data
is part of the DEEM software which we use; again, it stands for the Dietary Exposure Evaluation
Model. The consumption data from there is derived from USDA's continuing survey, food intake of
individuals. They conducted it in 1989 and 1991 and did it again in '94- '96 and I think they're
planning on doing another round in 2000-2002. They statistically sample people around the country;
a total of 10,000 people for three days, asking them to write down everything they eat. So you end
up with 30,000 people-days of information. Again, those are real dietary data. And that's the
baseline of our assumption for consumption data, the 30,000 person-days. That's what we use to
calculate what their exposures are when we do the risk assessment. It takes into account such
differences as age, sex, ethnicity and race, season, region of the country, etc. So that's where the
consumption part of the data comes from I'll talk a little bit about the DEEM software. What that
does is it combines all the information that we've received from consumption and exposure and the
RFD together and prints out a risk. The inputs to the DEEM software combine all the information
we know together in a proper manner. One input is toxicity information in the RFD; that's derived
from toxicity studies as I indicated before. You look at the toxicity endpoint and apply a certain
number of safety factors. The RFD, you remember, is the maximum safe dose, which tells you how
big the risk cup is. Exposure information is the second part of this input; it could include the crop
field trial residues which I described to you before, but it also could include a number of refinements.
For example, we could insert USDA's pesticide data program data, if were doing a chronic
assessment. We could incorporate processing factors if we know when foods are processed, corn
into corn oil, for example; if we know that that's reduced by a factor of 100-fold in the deodorization
process, we could incorporate that. Percent of crop treated could be incorporated as well. The
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output from the DEEM software is the exposure level, a distribution of exposure levels. It's given in
milligrams of pesticide per kilogram of body weight per day. And that tells you how much is in the
risk cup. It also includes the risk which is expressed as a percent of the reference dose, or percent of
the maximum safe dose, or equivalently how full the risk cup is. So that's the output that we use in
our risk assessments. If the exposure exceeds the safe dose, we use a tiered approach to refine the
crop field trial residue inputs.
The next slide shows the conclusions. These are the first two conclusions; the latter two will be
covered this afternoon when I go through the tiered approach that we use, as well as some of the
residue refinements that we could use to refine our risk assessments. The two basic conclusions are:
FQPA has had major impacts in the way exposures are assessed and risks are calculated at the
Agency, requiring us to aggregate exposures and look for the probabilities of potential co-
occurrences from residential, drinking water and dietary sources. The second main key point is, risk
is calculated from an equation which combines toxicity information and exposure information.
Exposure information is derived from pesticide residue levels in food and the amounts of these foods
consumed.
Are there are any questions? I'll go through the tiered approach as well as risk refinements at the
sessions this afternoon. Yes, go ahead.
JOANNE CUMMINGS: What do you do if pesticide residues are found which are above the
tolerance level, or a residue is found from a pesticide that is not authorized for use on the food being
analyzed?
MILLER: Those would be considered illegal uses. That's an enforcement issue. PDP collects data,
FDA collects data for enforcement purposes, and if there are flags on that if they detect a crop has
higher residues than the allowable tolerance, for example, that would signal them that there is an
application or illegal use problem and the FDA would cover that. So, at this point, no, we don't look
at illegal uses. The gentleman in the beard.
MAN: Do you consider the effect of pesticide residues on birds or animals other than humans?
MILLER: The ecological effects are done in a different division. I'm not very familiar with what they
do; they have their own toxicity criteria. They're more concerned with ecotoxicity and the health of
populations of organisms, rather than human health, which is the concern of the Health Effects
Division the toxicology to individual organisms instead of populations of organisms. So, no, they're
different. Go ahead.
MAN: Why do you use a factor of 100 as opposed to another factor?
MILLER: Why 100 as opposed to another factor?
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MILLER: Originally 100 was the default. 10X was for interspecies; between rats and humans. The
other 10 to make 100 was for sensitivities within the human population the expected potential
sensitivities on an order of magnitude. So, 10 times 10 would be 100. As part of FQPA, there was
concern that there may be infants and children who have special sensitivities that weren't accounted
for by that 100-fold factor. And so what FQPA required was that, unless registrants submitted data
which showed that infants and children were not more susceptible, you'd essentially incorporate it up
to another 10; so the default is 1,000. If they submit information that indicates that infants and
children are not more susceptible, then we can go back to 100. But again, that needs to be something
that the registrants submit; otherwise it's 1,000.
MAN: What do you do when illegal pesticide residues are found on the sampled food?
MILLER: As far as enforcement goes, that's FDA's responsibility. The EPA doesn't enforce the
residue tolerances; it's the FDA that sends out the inspectors and will seize the crop if it's been
illegally treated. In general, it's something like if they find 1% of the crops has illegal residues. Most
of it is not because residues are over tolerance; most of it is it's present but not registered for use on
that crop. It could easily have gotten co-mingled with other crops that ended up being treated.
Oversprays and things like that. So, in general, I'm not sure but it's something like on the order of
1%; so it's a small percentage that they find. And a lot of it probably isn't misapplication, a lot of it
might be overspray, for example, from other farmers or intermingling from other crops. There are
generally very low levels.
MODERATOR: How about one more question before the break, and then again, after the panel
there will be another chance to ask questions.
MILLER: OK, go ahead.
WOMAN: Can you clarify how the DEEM software works?
MILLER: What the software will do, it can do either a point estimate or a probabilistic estimate. Let
me just talk about probabilistically. You have the 30,000 person-days of food consumption there.
What it will do is assign a residue to each; if somebody ate an apple, corn and a banana, for example it
will assign a residue to each of those. So that person's total exposure would be calculated. And it
ends up being ranked; you would pick an exposure at a high-end level, for example, at this point at
99.9. We have real diets and what we do is plug in residue concentrations from field trials as a first
cut, from moderating data if that's available. Incorporating things like percent of crop treated, and
processing factors. And for each individual person, each individual real diet, we look at what the
exposure is. And then compare that to the maximum safe dose. So it's for the 30,000 diets that we
look at.
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Panel Discussion
Moderator - Andrew Triolo: I would like to start the panel presentations by introducing Rob
Koethe, who is responsible for setting up the meeting. Rob is the regional pesticide expert in the
EPA-New England Office. In that role, he provides technical support and guidance to the New
England State pesticide regulatory programs. He also advises the educational, scientific and
industrial communities and the general public on various pesticide issues. Prior to coming to
work for EPA, Rob worked for eight years as the Integrated Pest Management advisor with the
University of Illinois Cooperative Extension Service. Rob has a B.A. in biology from Gettysburg
College, an MS from Penn State University, and his Ph.D. from North Carolina State University.
Rob will be our lead-off speaker, and we'd like to have each of the speakers take about 15
minutes for their presentation, and save the bulk of the time for questions and answers. And at
the question and answer period, I would ask that the morning speakers join the panelists on the
dais. Rob?
KOETHE:
The panel is composed of representatives from several different parts of EPA and other agencies
that have different perspectives on food quality protection, and we all have different roles in the
implementation of FQPA. EPA Region 1 works with the six New England states, and EPA has
10 regional offices around the country. While each of the regional offices have their own
priorities, whether it be helping implement the Food Quality Protection Act, or other areas, the
regional offices share certain core responsibilities to work with state programs and implement
federal environmental laws.
This presentation starts with a brief description of how the Region 1 Pesticide Program operates.
I'll give an overview of some of the important pesticide issues and highlight some of the Food
Quality Protection Act activities that we are involved in, and then finish up with some comments
on activities that we plan to conduct in the future.
For each of the EPA programs we have responsibilities to ensure that federal environmental
statutes are implemented. In the case of the Pesticide Program, we work closely with our state
partners. For pesticides, we have cooperative agreements with the states, and the states have
primaiy responsibility for enforcing pesticide use laws, and certification and training of pesticide
applicators. In Region I we need to identify our priorities very carefully; our two main priorities
are to support the state programs and to support regional and headquarters' initiatives.
We're fortunate that in New England the state programs are strong, and all New England State
programs have laws that are stricter in some areas than the federal laws are. For example, all
New England states have some type of lawn care posting and/or notification law. New England
states also required special permits for certain pesticide applications.
Our second priority is to help implement headquarters' and regional initiatives. While these
initiatives change over time, it seems to me that once an issue surfaces, such as worker protection,
it never really goes away, it just becomes part of the on-going activities, and a number of issues
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have been raised over the eight years that I've been with EPA. Some of the regional priorities we
support are Indoor Air, the Urban Environmental Initiative, and the Children's Initiative, and we
also work on tribal issues.
Our next slide shows an expanded list of some of the national priorities that are also very
important to the region. Especially important, in addition to the Food Quality Protection Act, are
groundwater protection, which Mindy noted this morning, integrated pest management, the
Pesticide Environmental Stewardship Program, and certification and training of pesticide
applicators. I'd like to make few comments about groundwater protection.
Several years ago EPA proposed a rule to protect groundwater resources from contamination by
those pesticides which have been shown to be the greatest threats. The final rule is expected any
time now. This law is a little different than the Food Quality Protection Act in that it is aimed to
protect groundwater as a resource so, it's aimed at public health but it's also aimed toward
environmental protection.
Other priorities of the regional office are integrated pest management and the Pesticide
Environmental Stewardship Program. These are non-regulatory programs but they're important
to us because they contribute to reduced pesticide use and risks to people and the environment.
USDA Extension Service has developed strong Integrated Pest Management (IPM) programs for
many crops. EPA support has been especially strong for IPM in non-agricultural areas, especially
urban areas.
I'd like to make a few comments about the Pesticide Environmental Stewardship Program, which
emphasizes reduced risk and reduced use of pesticides. In Region 1 we've been able to support a
number of research projects through grants from the PESP program, and some of them were
mentioned by Mindy earlier today. The Vermont Dealer Education Program; an investigation of
alternative methods and reduced-risk management methods for controlling the blueberry maggot
in Maine on low-bush blueberries; a review of parts of the Massachusetts Partners with Nature
Program, kind of an assessment; and support for biological control in greenhouses.
Now I'll discuss what we're doing about the Food Quality Protection Act, which is the next slide.
The Food Quality Protection Act is a good example of a high priority national program, and also
is very important here in Region 1. Some of the efforts that we have done to get the word out on
food quality protection are: distribution of materials; ever since the law was passed in 1996, we've
been sharing fact sheets and the information that's developed to our partners and the public. We
respond to special requests for additional information on the Food Quality Protection Act. In
1998 we had a meeting between Lynn Goldman, former Assistant Administrator for Pesticides
and Toxic Substances, and a group of New England stakeholders.
Looking at each of these areas in a little more detail, distribution of materials. Here are some of
the materials that are available: A lot of this information is also available on the Office of
Pesticide Program's Internet site. Just so you have an idea what some of these things look like, in
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your packet you have a copy of a "For-Your-Information" fact sheet on FQPA, which gives a
very good overview of the Act.
There is information available from the Tolerance Reassessment Advisory Committee, and the
schedule that you have has been shared with that group. The TRAC material is also available on
the Internet.
The most recent piece of outreach information that we've distributed is the Consumers Pesticides
and Food Right-to-Know brochure, which is also in your packet. Generally, we first share the
materials we have with the pesticide state lead agencies, and then the cooperative extension, and,
finally we respond to requests for information. Because we work most closely with the state
pesticide regulatory agencies and Cooperative Extension, we get a large number of requests from
them, but we also get requests from other parties including the regulated community, public
interest groups and the public. An especially interesting request was from the New Hampshire
legislative committee on agriculture and the environment. When the FQPA law first came out, the
committee was trying to get a better handle on what its impact would be on the states. The New
Hampshire Division of Pesticide Control and then the regional office staff briefed the committee;
that was followed by a briefing by Dan Barollo, the former director of the Office of Pesticide
Programs.
We held a meeting with Lynn Goldman last spring, and my estimate was there were about 30
people present at that meeting. They represented many of New England's major commodities
including cranberries, blueberries, small fruits and vegetables, and potatoes. There were also
people present from EPA Region 1, state programs, state departments of agriculture, universities,
public interest groups, and the pesticide industry. Some of the issues that were raised at that
meeting were some of the ones that are part of the program today. Most of the time was spent
talking about data needs and assessment, and the sense that I got when the meeting began was
that some of the people present were skeptical about how serious EPA really was about getting
additional information, so there were a lot of logistical questions. Lynn Goldman agreed that this
is an area that will need additional follow-up. Risk issues were another area of discussion at that
meeting, and there was some discussion about the assumptions for field sampling data. And of
course, a lot of this was in the context of the organophosphate insecticides, because it was known
that they are among the first pesticides to be reviewed, and there have been rumors that they
would be canceled. Dr. Goldman assured the group that there was no intention to completely
eliminate OP's. She also emphasized the importance of the Tolerance Reassessment Advisory
Committee, and that committee has really grown in importance. At that meeting it was decided
we ought to have some type of follow-up, and this conference today is part of our follow-up.
We assembled a planning committee, which included representatives from all the state lead
agencies and the cooperative extension services, and we looked at the issues that were raised at
our roundtable meeting. We also scanned the newspapers to get some insight on what FQPA
issues are most important to people. We also decided that some type of interchange with the
stakeholders would be important.
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The way this conference is laid out is that after our panel discussion there will be a good amount
of time for questions and answers. In the afternoon we expect there to be a lot of focused
discussion on the session topics. If you have questions or points that you'd like to raise with some
of the speakers this morning, please do so. All of the speakers will be around until the end of the
meeting with the exception of Jim Jones, who has to leave after lunch. So, try to catch up with
the people that you need to talk to.
Finally, as follow-up to this meeting, we plan to write up the proceedings and we'll get that
information out to you with as many of the support documents as we can. We're going to include
a summary of the meeting that we had with Lynn Goldman last year in the proceedings. The
proceedings will provide a snapshot of where we are with regard to Food Quality Protection Act
at this point.
In the regional office, we plan to expand our outreach. We're hoping to reach more audiences
and partners on pesticide and food safety issues, and also on the Food Quality Protection Act.
Some of the other panelists will discuss something called the Agricultural Initiative, which was
started along with the Food Quality Protection Act a couple of years ago. At present this
program is a pilot but there are rumors that the program will be expanded to include all 10
regions. Last year there were four regions that were selected for pilot programs, including
Region 4, Atlanta; Region 5, Chicago; Region 9, San Francisco; and Region 10, Seattle. Those
regions received some support from headquarters, including a full time position and grant money,
and they have been able to do a lot of great things relative to the Food Quality Protection Act.
Again we're hoping the program will be expanded to include all 10 regions.
We try to stay active in IPM and the Pesticide and Environmental Stewardship Program, and we
do our best to make sure that these things complement each other. I already mentioned that we
expect to expand our outreach as much as we can. We're going to make greater use of the
pesticide page on the Region 1 web site, and when we get the proceedings completed from this
conference, we'll have that available there; we're also going to improve our links with some of the
resources that are available at headquarters.
MODERATOR: Thank you, Rob. Our next panelist to speak is Lora Lee Schroeder. Lora is the
Food Quality Protection Act specialist in the Region 4 office. Ms. Schroeder has held this
position since 1998. Prior to accepting her position with EPA, she was the Pesticide Division
Director of the Georgia Department of Agriculture. She was in that position for six years, and
before that she was the Pesticide Branch Director. Ms. Schroeder has also served as Agricultural
Manager of the Georgia Department of Agriculture. She holds a B. A. in English from Berry
College, a B.S.A. in Horticulture from the University of Georgia, and an M.P.P.M. in Plant
Production and Plants Management from the University of Georgia. Ms. Schroeder...
SCHROEDER: One thing you didn't mention, which I'd like to share with you, is I represented
the state pesticide control officials on the Tolerance Reassessment Advisory Committee, had the
opportunity to hear many of their discussions and provided input into some of the science policy
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issues. I served on Work Group Number One, which dealt with a number of the science policy
issues. I'm new to EPA. I bring to it some perspective from the pesticide control officials and the
agricultural community. I worked very closely over the years on processing Section 18's and
approving pesticide registrations, and also have had the opportunity to direct the structural
pesticide control program in the state of Georgia. While we haven't heard a whole lot about
indoor residential exposure, that is one of the elements of the Food Quality Protection Act, so
hopefully that experience will help me as we move closer to implementation. I asked, when I
came on board, what do you want me to do, and they said, well, what do you think we should do?
So, I came up with my own agenda.
One of the first activities I was involved in has to do with communication; you're dealing with
some very complex issues, and you have to communicate this to a public who doesn't have time to
sit at a computer all day and search the Internet for this information. So, one of my first tasks was
to come up with a means of communicating information about the Food Quality Protection Act to
the general public. And my idea of doing that was to develop an information update newsletter,
which I've done and have published a couple of editions. I have copies of that which I brought
with me that will be available to all of you. Some people have asked me how I came up with the
name; it's called Alphabet Soup. Now the reason for Alphabet Soup is, we're dealing with 24(c)'s
and Section 18's and FIFRA, and FQPA, and all kinds of acronyms, and that's the genesis for
Alphabet Soup. The newsletter discusses some of the good activities that are going on in the
region, the grant programs that we have and how we're working with those individuals in our
state. Well have at least one article that will discuss some of the more progressive activities that
are going on. We have a program in the Mississippi Delta with the cotton farmers where they're
promoting best management practices.
In addition to developing Alphabet Soup, we've been giving a lot of presentations. I've met with
the commercial applicators of Georgia, and had an opportunity last week to talk to a very large
group of commercial pesticide applicators. We had 15 remote stations for that presentation, so a
large number of commercial applicators were able to take advantage of the presentations that
were given. Though I think a lot of us here have heard a lot about FQPA, there are many people
out in the field who really don't have a clue as to what it is all about. So, one of my goals is to try
to get information out and as far down as possible. We've talked to professional crop
management associations; we've talked to the national Pesticide Information Retrieval System.
Since I've been on board I've met with NASDA, the National Association of State Departments of
Agriculture; I had an opportunity to work with those folks over the past couple .of years in
developing pesticide regulation policy for that group. A lot of the work dealt with the Food
Quality Protection Act and associated issues. Agriculture Commissioners are a very important
group of people to inform about FQPA.
We have an Agriculture Initiative grant that is specifically related to FQPA. EPA has a lot of
other grant activities that may be targeted at pollution prevention and other areas, and I'm trying
to coordinate our activities with other programs like the Water Program I'm looking for sources
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of funding that will meet our goals as well as their goals. One of the first things I worked on was
the Sustainable Development Challenge Grants, where we were looking at a lot of community
activities. We had some proposals from that group which dealt with pollution prevention and
agricultural activities, such as organic production and preservation of greenspace, and we put
forward two which had strong agricultural pesticide components. We have several on-going
projects under the Agriculture Initiative, and of course I'm working very closely with those
individuals. I think sometimes we fund a project and then we kind of forget about it, and don't get
the information out as rapidly as we could. There are some really good things that are coming out
of these various projects, which I want to share with other regions and groups that are interested
in these products. At the meeting with Imperis in Hilton Head last week, I was able to show an
excellent video that was developed by our Mississippi project on the cotton stewardship activities
that they're doing. It was very well received.
Of course, a lot of what we do in the regional office is traditional enforcement type activities, and
I think you've already heard about what's happening with traditional activities in Region 1. We
haven't gotten into the enforcement aspect of FQPA yet, but as decisions start being made
concerning labeling changes and risk mitigation measures, the regions will have to make sure that
the label provisions are abided by. There will be responsibilities for us to educate those who are
used to using pesticides in a certain way that they need to start using them in another fashion.
Another thing we're doing is providing feedback to headquarters. Regions have a much closer
relationship with the state pesticide control officials, with the farmers, with the various ag
organizations than does EPA headquarters, and we're able to bring information from those groups
and pass it back up to headquarters. We do get questions about what's happening with the peanut
farmers in North Carolina. What pesticides are of concern to them. What alternatives might they
have. And we're able to respond to those questions and put the people in touch with the right
group.
I work on various committees, I think one might be interesting to you. In Region 4 we have the
Pesticide Environmental Stewardship Committee, which has individuals on it representing
organizations outside of EPA, for example in the chemical industry, the extension service, and
medical persons, and we're looking at developing an award that will recognize outstanding
stewardship activities in Region 4. We feel there are a lot of good things going on out there that
farmers and others are doing, and I think it's important to recognize and encourage those efforts
that are taking place in our regions, and to help promote even more of that type of activity.
I'm also spending a fair amount of time training our own staff. We have 15 project officers and
program specialists who haven't had an opportunity to spend a lot of time understanding what
FQPA is all about. Part of my task is educating our folks and making sure that they understand
the importance of this piece of legislation, and what their roles ultimately will be.
We traditionally have had a very close working relationship with the State Pesticide Control
Officials in Region 4. Also we've had a very close relationship with the Extension Service and
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meet periodically with those individuals. I have passed a lot of information to state agencies that
we have received from headquarters and some information that I have developed myself on a
fairly regular basis.
I think one of the things that's happening with FQPA is we have so much information that's
coming at us, people don't know when important deadlines are being reached and don't know
what the opportunities are for input. So, I'm trying to make sure that people are informed early
enough so they'll have an opportunity to provide input. Thank you.
MODERATOR: Thank you Lora Lee. Our next panelist is Paula Fairfield. Paula is with the
New England district of the Food and Drug Administration. As a supervisor of the Public Affairs
office, she's responsible for managing the educational and outreach programs. Paula also oversees
the activities of several staff including the Consumer Complaint Coordinator. Ms. Fairfield has
held her current position for 15 years. Prior to that she was an investigator for six years. Ms.
Fairfield is a member of the Association of Food and Drug Officials of Rhode Island, and she is
currently treasurer of the Northeast Food and Drug Officials Association. She has received
numerous awards including the National Performance Review Hammer Award and the FDA's
Outstanding Achievement Award. Ms. Fairfield holds a BS in Education from Framingham State
University. Ms. Fairfield.
FAIRFIELD: Good morning. Listening to Alphabet Soup and the need for education on the
Food Quality Protection Act reminds me that when Allan Christensen called me and asked me to
be on this panel, I said, Food Quality Protection Act? Now, that should have something to do
with what the FDA does. Well, in looking it up I found that yes it does have something to do
with what we do in FDA, however, it's main impact has been on the EPA.
FDA is responsible for enforcing the Federal Food Drug and Cosmetic Act and FIFRA, the
Federal Insecticide, Fungicide, and Rodenticide Act. The Food Quality Protection Act amends
those two laws. The greatest impact on the consumer is that there is supposed to be a more
plentiful and a safer food supply by allowing newer and more effective pesticides on the market.
As was the case before the passage of this law, EPA is responsible for registering pesticides and
for setting residue tolerance levels in food. And FDA enforces the tolerance levels established by
EPA. The law did give enhanced enforcement power to FDA in that it allows the imposition of
civil penalties; fines of up to $500,000. The act removes pesticide residues in processed foods
from the definition of food additives which is how FDA regulated them. And therefore from the
restriction of the Delaney Clause which said that if an additive caused cancer in man or animals, it
could not be used in the food supply. The revised measure of safety of pesticide residues in
processed food and raw food is one in a million over a lifetime.
The FDA is charged with enforcing tolerances in imported foods as well as in domestically
produced foods shipped in interstate commerce. USDA's Food Safety and Inspection Service
monitors the pesticides residues in meat and poultry and in certain egg products. FDA acquires
incident data on particular commodity pesticide combinations and we carry out a market basket
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survey each year to look at these levels. This is called the total diet survey. And since 1991
USDA's Agricultural Marketing Service has carried out a residue testing program on raw
agricultural products and various processed foods.
There are a lot of people looking at the pesticides in the food supply. FDA samples individual lots
of domestically produced and imported foods and analyses them for pesticide residues to enforce
the tolerances. Domestic samples are collected as closely as possible to the point of production in
the distribution system. Import samples are collected at the point of entry into U.S. commerce.
Emphasis is on raw agricultural product which is analyzed as the unwashed, unpeeled raw
commodity. Processed foods are also included. If residues are present which are above EPA
tolerances, or if there is no tolerance for a particular pesticide on that food combination and these
are found in domestic samples, FDA can invoke various sanctions such as seizure and injunction,
and we now have the ability to assess civil penalties. For imports, shipments may be stopped at
the point of entry when illegal residues are found. Detention without physical examination is what
we now call it. It was previously called automatic detention. That may be invoked for imports
based on the finding of one violative shipment if there is reason to believe that the same situation
will exist in future lots during the same shipping season for a specific shipper, grower, geographic
area or country.
Domestic and import food samples collected are classified as either surveillance or compliance
samples. Most of the samples collected by FDA are the surveillance type; that is, there is no prior
knowledge or evidence that a specific food shipment contains illegal pesticide residues.
Compliance samples are taken in follow up to the finding of an illegal residue or when other
evidence indicates that a pesticide residue problem may exist.
Factors considered by FDA in planning the types and numbers of samples to collect include: a
review of recently generated FDA residue data; regional intelligence on pesticide use; the dietary
importance of the food; information on the amount of the domestic food that enters into state
commerce and the amount of imported food that arrives at the ports of entry; chemical
characteristics and toxicity of the pesticide; and pesticide usage programs. To analyze the large
number of samples on which pesticide treatment history is usually unknown, FDA uses analytical
methods capable of simultaneously measuring a number of pesticide residues. These multi-residue
methods can determine the amount of residue of about half of the approximately 400 pesticides
with EPA tolerances and many others with no tolerances. The most commonly used multi-residue
methods can also detect many metabolites, impurities and alterations of products of pesticides.
Single residue methods or selective multi-residue methods are used to determine pesticide
residues in foods. A single residue method usually determines one pesticide whereas a multi-
residue method measures a relatively small number of chemically related pesticides. The single
residue method is usually more resource intensive.
Personnel in FDA's field offices interact with their counterparts in the states to increase FDA's
effectiveness in residue monitoring. In many cases we have memoranda of understanding or more
formal partnership agreements that have been established between FDA and various state
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agencies. These agreements provide for more effective monitoring of the pesticide residues by
broadening coverage and eliminating duplication of effort, thereby maximizing federal and state
resources allocated to pesticide activities. These arrangements vary from data sharing, joint
planning and state collection of samples for FDA examination, to FDA and state division of
collection, analytical and enforcement follow up responsibilities, for the individual commodities or
products of particular origin. That is, imported versus domestic products.
We also participate in several international agreements in an effort to minimize incidents involving
violative residues and trade barriers. A standing request exists for information from foreign
governments on pesticide use on their food exported to the U.S. This is a provision of the
Pesticide Monitoring Improvement Act. Under the auspices of the North American Free Trade
Agreement, the United States, Mexico and Canada have established a technical working group on
pesticides which serves as the focal point for all pesticide issues that arise among the three
NAFTA countries. One of the working group's major goals is to ensure that pesticide registration
and maximum residue tolerances in the three countries are harmonized to the extent practical
while strengthening protection of public health and the environment.
FDA's Total Diet Study is the other element of our pesticide residue monitoring program. In
conducting the study, FDA personnel purchase foods from supermarkets or grocery stores four
times a year, once from each of four geographic regions of the country. The 261 foods that
comprise each market basket sample represent over 3,500 different foods reported in USDA's
consumption surveys. These foods represent what an average family of four would normally eat
within a week's period of time. The foods are prepared table ready and then analyzed for
pesticide residues as well as radionucleides, industrial chemicals, toxic elements, trace and macro
elements, vitamins B and folic acid. The levels of pesticides are used in conjunction with the
USDA food consumption data to estimate dietary intakes of the pesticide residues.
In 1997, 9,843 samples of which 9,652 were surveillance and 191 were compliance were analyzed
for regulatory monitoring purposes. Of these, 4,501 were domestic and 5,342 were imports.
You can find the results of those on FDA's home page on the web. If anyone is interested I can
give you the address a little later. I'm just going to give you a brief summary of the results. As in
earlier years, fruits and vegetables accounted for the largest proportion of the commodities
analyzed. Those two commodity groups comprised 65% of the total number of domestic
surveillance samples. And in 1997, no violative residues were found in 98.8% of all domestic
surveillance samples. Overall, no violative residues were found in 98.4% of the import
surveillance samples. This figure in 1996 was 97.4 and in 1995 it was 96.8%. You can see the
figures are following a downward trend.
An adjunct survey of baby food that has been done from 1991 through to the present has only
found evidence of small amounts of pesticide residues in those foods and those levels also have
been going down. In summary, a total of 9,843 samples of domestically produced food and
imported foods from 97 countries were analyzed for pesticide residues in 1997. Of these 9,652
were surveillance. Again, these are collected when we have found no evidence of a problem. No
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residues were found in 66% of both the domestic and the imported surveillance samples. The
higher violation rates in the 191 compliance samples reflect the fact that they are collected and
analyzed when a pesticide problem is suspected.
FDA also collected and analyzed animal feed samples of which 460 were domestic and 42 were
imports. 62% of the domestic samples and over 52% of the import surveillance samples
contained no residues. Most of the Total Diet Study findings for '97 were generally similar to
those found from earlier periods and, again, they were going down.
I would like to mention the good agricultural practices that FDA has published in the Federal
Register in conjunction with the USDA. These are guidelines for farmers to assure that their
produce is as safe as possible. In addition to dealing with pesticide usage they deal with sanitation
practices on the farm.
We have been finding that as the problems with pesticides have been decreasing, the problems
with the microbes in the food supply are increasing dramatically. A few years ago we never heard
of cyclospora in raspberries. We thought they were perfectly safe to eat. Now there are
questions about them. The microbe issue is really the bigger issue that FDA is involved with at
this point in time. Our pesticide activities are going down because we've been finding less and
less residue in the food supply and our activities as far as the microbes are concerned are
increasing.
We have finalized HASSOP regulations for the seafood industry. We've published proposed
HASSOP regulations for the fresh fruit juice industry. And the trend seems to be going towards
HASSOP for the food industry, and probably for the farmer at some point in time in the future.
Thank you.
MODERATOR: Thank you Miss Fairfield. Our next panelist is Evelyn Washington. Evelyn is
the Associate Chief of the Targeting and Analysis branch in the EPA's Office of Groundwater and
Drinking Water. Her branch is responsible for the development of regulatory tools such as cost-
benefit analyses, contaminant candidate lists, national contaminant occurrence databases and lists
of treatment technologies, as well as development of individual contaminant regulations such as
those for arsenic and radon. Prior to becoming the Associate Chief, Evelyn served as team leader
for the Contaminant Identification and Selection Team that developed the drinking water
contaminant candidate list. Miss Washington is a chemical engineer by training and began her
career at EPA in 1988. She received her bachelor's degree in chemical engineering from the
University of Maryland at College Park. Prior to working for EPA, Ms. Washington worked for
the United States Department of the Navy. Ms. Washington.
WASHINGTON: I'm going to start out by confessing that I'm not an expert on FQPA. The term
risk manager applies to the type of work that I do. I'm in the drinking water program. We have
had some involvement with FQPA related to drinking water, and in terms of risk management we
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rely on the risk assessors or the toxicologists who develop the reference doses. We take that
information and develop the regulations which public water systems have to comply with.
The topics I'm going to go over today are: highlight some of the main points of FQPA, talk about
the Safe Drinking Water Act, and then get into some of the common elements in both. The
common elements and the need for both programs, the pesticides and the drinking water program,
to get data from one another requires us to improve our coordination between the two offices, so
I'll spend some time on that as well.
I came to the drinking water program in 1991. When I arrived there I was surprised to find that
the drinking water program did not have what we call an occurrence database. There is no one
place that we can go to in our program to look at concentrations of any contaminant in drinking
water. We do have a database that is related to compliance. It's related to whether a public water
system violates a monitoring requirement or violates a maximum contamination level (MCL). In
the case when an MCL or standard is violated the public water system through the state reports
concentrations to the agency.
There's no one database where just routine monitoring and parametric data is reported to us. But
that's going to change. We are in the process of building what's called a National Contaminant
Occurrence database. That's going to be on-line by August of'99. At that time, public water
systems will have to monitor for contaminants that are regulated, contaminants that have
standards, as well as other contaminants that the agency specifies and has to report to a central
database whether the concentrations are below or above the MCL. We're moving in the direction
of building such a database to support the program. And so the reasoning behind the fact that a
database never existed, back in the late >80s, we were spending a lot of time regulating
contaminants that Congress said you shall regulate. There were about 150 contaminants, so it
didn't matter whether they occurred or not in public water systems, we had to set standards.
The emphasis of the program now is going towards more of a risk assessment and risk-based
standard approach, and again, we need the data to do that and are building the database. A lot of
people call us and ask us what contaminants we are finding in drinking water, and we've never
been able to answer that at this point.
Concerning FQPA, I'm not going to go into a lot of the details. I think Mindy and David who
presented earlier went through a lot of that, but I want to point out I think there are three key
components that you'll see as a reoccurring theme, not in the Safe Drinking Water Act, but in our
improved coordination effort. One deals with this whole concept of risk assessment where we
look at aggregate risk; where we try to use the best science available to assess those risks. The
second element is special consideration for infants and children. And we'll talk about that a little
bit later. And the other component that I want to point out is this right to know aspect of FQPA.
The Safe Drinking Water Act amendments of'96 were passed about three days after FQPA was
passed, and those amendments require us to put greater emphasis on our assessments, that is, our
assessments in terms of risk as well as our cost-benefit analyses that we have to do. So, stronger
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approaches in preventing contamination deal with source water protection issues. Wellhead
protection as well as watershed protection issues are made stronger by these amendments. The
Safe Drinking Water Act requires public water systems to report to consumers the status of how
well the water systems met the MCLs or the standards, and some description of what that means
so consumers can understand what the risks are that are associated with drinking water. That is
comparable to the FQPA brochure that was put out regarding pesticides in food.
Regulatory improvements in terms of better science, prioritization and improved risk assessment
were part of the Safe Drinking Water Act. I mentioned additional cost-benefit analysis that we
have to do, provisions where we do a lot more peer review than we did. We use the best
available science in our assessments. We go through a process of prioritization, so that we
identify contaminants that we feel are the highest priorities in terms of requiring future regulations
or revisions to current regulations.
The last two elements are a state drinking water revolving fund ~ this is a pot of money that can
be made available to states and public water systems through grant mechanisms to help the
smaller public water systems comply with the regulations. There are additional Agency provisions
which meet the needs of smaller public water systems requiring greater flexibility in terms of
compliance and so forth, but I think the drinking water state revolving fund is the biggest element
related to small systems.
Next slide. In terms of common elements, pesticides and degradation, in the drinking water
program we deal with not only pesticides and degradation products, we deal with the
microorganisms, we deal with disinfection byproducts, other synthetic organic contaminants and
inorganic contaminants as well as radionucleides and those compounds. So, the pesticide
component of what we do is just a piece of the pie for us. The use of the best available science is
a common theme through both Acts. In the Safe Drinking Water Act, we are mandated to
consider sensitive sub-populations when we do a risk assessment and it specifically identifies
infants and children as a sensitive group, but it also mentions elderly immuno-compromise. So,
again, there's a common theme there.
I mentioned the consumer confidence reports and these reports that public water systems have to
include in the water bill. And then there is the endocrine disruptors issue. Both statutes mention
testing and screening for endocrine disruptors, and there's a program in the agency called the
Endocrine Disruption Testing and Screening Advisory Committee, EDTSAC. That committee is
working from the language in the Safe Drinking Water Act as well as FQPA to develop a testing
and screening program that the Agency can use to analyze endocrine disrupting compounds, or
contaminants considered to cause endocrine disruption.
Another element that I didn't include up there is public participation. Within the Safe Drinking
Water Act there are a number of elements which encourage a greater level of public participation
than previously required. We have to provide an opportunity for public comment on assessments
that feed into regulatory development before we get to the proposal stage. When we do a
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proposal, we'll publish it in the Federal Register, take public comment on it and then do a final
rule. We have an added step where we have to do a Health Risk Reduction and Cost Analysis.
We publish in the Federal Register for comment at least six months in advance of a proposal, and
then put out the proposed rule again, seek comment on it, and then develop the final rule.
In an effort to meet our public participation elements, we've held a number of stakeholder
meetings on various topics that relate to developing drinking water standards. We've discussed
everything from how we're starting to do our cost-benefit analysis and the changes we're making
there to how we're identifying priority contaminants. The drinking water program needs some
assistance in terms of data to support the drinking water portion of this aggregate analysis,
because we should be the people that have that data. We have the authority in the Safe Drinking
Water Act to require public water systems to submit that data to us. So, we can use that
provision to get what we need and also to get the Office of Pesticides what it needs in order to
complete its assessments.
The other aspect of that is, in developing drinking water standards we rely on a lot of the same
health effects information that the Office of Pesticides has a really good handle on. So, again,
another swap of data would be appropriate to help us do what we need to do. A group of us got
together and started to look at how we could improve the coordination between the two
programs, and we identified a number of goals that we would like to achieve from this improved
coordination. I've listed most of them there. Some of them I've already dealt with. For instance,
we use common methodologies when we do our risk assessments. When we look at data
concerning the hazards of particular pesticides or degradation products, or when we look at
occurrence data we should come to the same conclusions. So, if you called up the folks in the
drinking water program and asked what's your estimate of the risk of pesticide X and then you
called up the pesticide folks and asked the same question that you'd get the same answer. We also
thought it would be good to have common priorities in terms of which contaminants we regulate,
and also contaminants that require monitoring by public water systems.
In the area of science policy, some of those issues are fundamental to the way you would do risk
assessment. This last one relates directly to the risk cup scenario. In the case when you're
dealing with an overflowing risk cup, we need a joint coordinated policy about how we're going
to deal with it. We've come up with some basic agreements that have been fed through the
management process. The first one goes a long way in creating a common human health risk
assessment methodology. When the Office of Pesticides does its hazard assessments that we use
the assessments that the Office of Pesticide has come up with. That we play in those work
groups, that we play in the science policy issues, and then when it comes down to having the final
assessment, we take that into our program to help us develop our drinking water standards.
In the discussion about common approaches to risk assessment, the particular issue that I'm
getting to here is the Ten X factor that's added on for addressing children's and infant's risk when
there's uncertainty. We're not sure in the drinking water program whether that's appropriate. So,
by talking about common approaches to risk assessment, if we find that there are situations where
34
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we won't be doing the same thing, we need to articulate why we won't be doing the same thing.
Sharing data on pesticide occurrence is important. This has been a major effort with the
development of the National Occurrence Database. We have made sure that the Office of
Pesticide Program folks that deal with the data systems are considered one of the major users of
our occurrence database. We're going to be requiring public water systems to monitor for certain
contaminants on the drinking water contaminant list. In developing that list we involved folks
from the Office of Pesticides to give us an assessment of the likelihood of some of these
contaminants appearing in drinking water, based on physical chemical properties and modeling
estimates. I think I mentioned the cross program involvement in science policy earlier. The
biggest element in this whole area of coordination is how we deal with the concept of the
overflowing risk cup.
In this work group we feel that the risk cup is the main issue that we need to get to. The other
underlying components get us to this main issue. If we agree that the risk assessments are done
and then come to the point where we look at the risk cup when you've included exposure from
food, exposure from water, exposure from residential use, and you have a cup overflowing what
do we do? Do we change the drinking water standard, or do we clamp down on some of the
uses? I'm not sure we'll come up with a canned answer. I think it might be pesticide specific, but
we'll see how it goes. And this is going to be one of the breakout session topics that we'll talk
about this afternoon.
The last element is the ecological risk assessment. In the Office of Water there is a component of
our office called the Office of Science and Technology that deals with developing water quality
standards. These are ecologically based standards and in some of our discussions with the Office
of Pesticides, we determined there may be a need to also look at common methods for assessing
ecological risk. We also put out in the Office of Water fish advisories where, if certain
contaminants are found in fish above certain levels, we issue advisories warning consumers about
consuming those fish. This whole area of fish consumption and fish advisories and fish action
levels is something that's come up in the discussion between the two programs. One concern is
that when we look at aggregate exposure, there are populations who consume fish at higher rates
than the general population. How do we account for that in these risk assessments that we do?
In terms of priorities among all of these things, getting to this issue about the risk cup is the
highest priority of all. We've taken these through our management all the way through the
Administrative Deputy level. We have a steering committee, which has been in existence since
October of last year. We are in the process of developing options that'll identify the nuts and bolts
of how we're going to make these agreements work and presenting those options to management
for decisions. This is something that is of great interest to both the Office of Water and the Office
of Pesticide programs. Our Deputy Administrator, Dana Minerva and Susan Wayland, the
administrator for the Office of Pesticide programs are both interested in what we're doing. We
dont have a definite time frame laid out for all of this, but these are the steps that we plan on
taking.
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You have a sheet in your packet called getting information. It talks about the Office of Pesticide's
program's web address. I want you to add the web address for the drinking water program. If you
look at that sheet, there's a word there. The last word on the end of that line is pesticides. If you
type in everything else and then in place of word pesticides type the word safe water as one word,
S-A-F-E-WATER, it will take you to our Office of Groundwater and Drinking Water web site.
We're also developing the occurrence database which we're going to make accessible through the
internet. So, if people are looking for occurrence data on particular contaminants, eventually that
will be the place to go once it's on-line.
MODERATOR: Thank you Evelyn. We've got about 10 or 15 minutes for questions. At this
point I'd like to ask Dave Miller and Jim Jones if they would join the other panelists so that they
can respond if any questions come up. OK. Yes, Bob.
MAN: I think there is a departmental misunderstanding of this whole thing. If the risk cup is a
function of total points, water, food and residential, how can you assess a standard for any one of
those if the total is going to be a function of what the other two are? We just heard a talk about
water, and I'm thinking they can set a standard on our intake of it, but that allows the residue in
water to be a function of what those other components are. And how do you say what's the
limiting component? I guess I just don't understand that.
MODERATOR: Get Dave Miller to do this one.
MILLER: I think what you're getting at is, how do we do it when there's a source coming from
food, a source coming from water and a source coming from residential, how do we combine
those three? One thing we can't do is assume worst case food on top of worst case water on top
of worst case residential, so what we're proposing is to do this assessment probabilistically.
There's a paper on the web that was presented a week ago to the SAP. It's an issue paper on how
we propose to do aggregation. If you go to the epa.gov/pesticides/TRAC web site, it shows up
as whatever last Wednesday's date is, and that indicates what we intend to be doing in terms of
the aggregate risk. What we propose to do is take into account the probabilities of the co-
occurrence of somebody treating the lawn at the same time he gets a high dose from food at the
same time he gets a high dose from water.
WOMAN: A separate side question is how do I find the paper on your web site?
MILLER: Actually you're right. It is the Scientific Advisory Panel, SAP. I was wrong. It's
capital S, capital A, capital P. It has to be capitalized, and there will be a date. They list all the
different dates, and it's last Wednesday's date when it was presented and the paper's there in Word
Perfect and Adobe Acrobat and HTML format.
WASHINGTON: I want to add something I think might help, because it was hard for me to
understand this when I first got into it. What we're comparing is a reference dose, which is the
calculated health level. You're looking at the exposures that you get from the different sources.
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MAN: You mean exposure from the different pathways.
WASHINGTON: Yes, exposure from the different pathways compared to that reference dose.
You're looking at something you calculated versus what you're actually measuring. I think that's
the intent of this risk cup scenario. The size of the cup is determined by the reference dose, and
you're apportioning based on exposure; apportioning your reference dose based on what you
measure in drinking water and what you measure from food consumption and what you're
measuring from residential exposure. Whether you actually have measurements for all of those is
another story. Does that help? When we set our drinking water standards, we assume that 20%
of the reference dose is the bottom line amount, the amount that one would consume through
drinking water, unless we have other data.. Most of the time it's the standard 20% because we've
not had a lot of data and we haven't looked at the data that the Office of Pesticide Programs has.
So, when we talk about risk cup at this afternoon session we'll get into some of these scenarios.
MODERATOR: OK. You're up.
MAN: Yes, I have a couple of questions that relate to risk assessment and how the FDA's role
plays in all of this. Specifically, how does the information the FDA and USDA have developed in
the real world historically over the years correlate with the field study data that's being used now?
That's the first part of my question. The second part of my question is, what analysis is being
given to the potential of the removal of pesticides increasing other risks to society? For example,
if I lose an organophosphate that prevents insects from piercing the skins of my apples before
harvest, and it's known that pierced skins at harvest will allow the E. coli in the insect inside of my
apple, and the removal of organophosphates allows an increase in notable pierces in apples, and
therefore a potential increase microbial contamination, is that risk measured?
JONES: Concerning the comparison between the crop field trials that are submitted by the
registrants and the marketing data that we receive from FDA as well as from PDP, when we have
the real world data that's what we prefer to use. We don't always have that. The crop field data
studies were done to support tolerances which represent the maximum legal residue. So, in order
to support that, those tolerances have to be done at the maximum rate and harvested at the
minimum pre-hlarvest interval. Otherwise if they use typical rates or typical PHI's you'd end up
with essentially illegal produce when the pesticide was used perfectly legally. We do use that
information from PDP or FDA when it's appropriate, when it's available.
MILLER: To answer the second part of your question, the statute requires that the pesticides
that they were looking at are safe, and it then defines safe as having a variety of characteristics.
The use of that OP in this example has to be safe, has to meet the standard. The way we get to
the point of determining which uses need to be modified or dropped if you do have a risk greater
than acceptable and an overflowing risk cup would be incredibly important to ultimately making a
determination. I think knowing that you may create a bigger problem on apples when such a
problem would not exist if you were to remove the use on another crop would be very important
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in determining which one to keep. So, it would be used more in the risk management as opposed
to any kind of risk assessment purpose.
MODERATOR: OK. Back there.
MAN: My concern is that FQPA may have a negative impact on pesticides in a whole bunch of
situations. When a particular pesticide has a broad spectrum of uses: in agriculture; smaller in
structural pest control. Are you going to decide that the risk cup is full and it's use is in a high
agricultural market, it sounds like it would force the manufacturers to eliminate this pesticide in
the small special markets. Are there any considerations to review the pesticides on the whole
spectrum of the market?
MILLER: Yes, again those kinds of considerations will be very important when you're trying to
decide which uses should be maintained and which ones shouldn't. The benefits provided by
structural pest control are clearly very significant and will be considered in the context of the risks
that are posed through those uses as well as the risks and the benefits of other uses ~ agricultural
and lawn care uses. Although we're going to have a very open process in coming to a consensus
about how to mitigate unacceptable risks, at the end of the day if the manufacturer's not going to
support the use, the manufacturer's not going to support the use. But it's never been perfectly
clear to me that their profit margins are highest on agricultural versus nonagricultural uses. I
think that may vary depending on the company and the chemical. So, I'm not sure that they will
all universally say we're going to get rid of this kind of use first.
MODERATOR: Joanne.
WOMAN: I have a question for Jim Jones. I don't mean to put you on the spot, but when you
were saying in the registration process your highest priority is to try to find products that are less
risky. Why should isoxyflutole be registered? Because in Vermont we probably never will allow
that pesticide to be used, so why would that be registered?
JONES: Isoxyflutole or "Balance". I'm perfectly happy to answer that question ~ it's not an
FQPA issue. That's a chemical that's very persistent and mobile and although it's a low use rate
herbicide, it's likely to leach at very low levels ~ we're talking about in the parts per billion or
parts for trillion even, get into ground and surface water, and it does have phytotoxicity issues
associated with it. It was registered in parts of the United States that have certain characteristics.
We basically determined that the benefits to the users exceeded the risks in certain parts of the
country. It was not allowed in those states where there was very diverse agriculture and thus a
possibility of the phytotoxicity issue becoming a problem. So, it was not allowed in the New
England states. It was not allowed in any coastal state, East Coast or West or the Gulf Coast. It
was basically allowed for use in the central part of the United States. Diverse agriculture and
more diverse ecosystems were the criteria we used, and we felt that the risks exceeded the
benefits in these more diverse agro-economic systems, and for the more monocultural areas we
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determined that the benefits of the use exceeded the risks, and thus it was registered there. It's
not clear to me that we would ever register it in Vermont. One of the interesting aspects of this
process is that for the states in which we proposed registration we asked all of them if they would
see it differently. If they thought that in their state risks really did exceed the benefits. A couple
of states took a very hard look at that and ultimately decided to allow for the use in their state,
but we made it pretty clear that if they felt that the risks of use in their state exceeded the benefits
we'd very seriously consider that in prohibiting it in that state.
MODERATOR: Yes, right there.
MAN: Yes, mine is kind of a general comment to Ms. Lubber. She had mentioned in her talk
that there were a lot of environmental statutes and that she is responsible for directing a staff of
800 people. I guess the thing that came to my mind is that here I am, part of a small farm
community and being in this setting in Massachusetts, the adage came up where Oonce the
embattled farmer stood". Itงs a big entourage of people, the small group of farmers is up against.
Farmers consist of 2% of the population in this country; probably less than one tenth of 1 % in
New England. I wanted to make a comment that you canงt close your minds to the intricate
system that we have provided for safe food supplies for our country and for the rest of the world.
In the things that are mentioned here today we have to work together and start the delicate
process. I believe the EPA will do everything to protect itself. Paula Fairfield mentioned some of
the programs FDA had in place today, including food monitoring for pesticides and other
substances on food. And I guess the question that everybody here needs to understand with the
Food Quality Protection Act is, when they open up this can of worms and Iงm looking at the
system we have in place, we growers will face more red tape and higher costs.
Marv Rosenstein: Iงd like to respond to the gentleman who made the comments about food
safety. The EPA and the government in general recognize that the U.S. food supply is the safest in
the world. I think the Food Quality Protection Act is going to make our food safer without
disrupting the very good infrastructure currently giving us our food supply. I think this is due to
safeguards built into the legislation. So I think the EPA is going out of its way to open the dialog,
to listen to farmers and the agricultural community. And I think the Act will make a good process
even better without hurting anyone. The goal is not to get the small farmer, the big farmer, or
anyone else.
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Appendix I
Briefing on Endocrine Disruptors
LeBelle Hicks, Pesticide Toxicologist, Maine Board of Pesticide Control
Note: LeBelle volunteered to conduct this briefing when Dr. Chris DiFonzo was unable to come.
1. The function of the Endocrine Svstem(s) is to allow the organism to deal with wide ranges
of environmental conditions including exposure to chemicals (natural and man made).
2. Endocrine glands include:
sex organs, thyroid, adrenals, insulin secreting cells in the pancreas, parathyroid, etc.
Note: From here on, these are Dr. Chris DiFonzo's slides
3. Endocrine Disruption definition:
A substance that causes adverse effects in individual organisms or offspring by changing the
endocrine function; e.g.,
mimic/block hormones;
affect hormonal tissue; and/or
interact with hormone receptors.
40
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The Endocrine Disrupter Hypothesis is:
Endocrine disrupters in the environment are causing adverse reproductive, developmental, and
other effects in wildlife and humans.
4. Problems in humans recently attributed to EDs:
decreased sperm counts
early puberty in females - 48% B/l 5% W by age 8
increase in hormone-related disease NOT related to better detection:
- Prostate cancer
- Testicular cancer
- Endometriosis
increase in birth defects
- Hypospadia
- Cryptorchidism
change in male/female birth rate
- very slight + male
5. What is known about EDs?
EDs are found in the environment
OCIs, PCBs, dioxins, etc. in sediments
also found in human and animal tissues
41
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EDs have affected animals
mink in Michigan, 1960s
hermaphroditic fish in England
Lake Apopka alligators
4 nony 1 phenol affecting salmon populations during spruce bud worm spraying in >70s
EDs have affected humans
DES in the U.S., 1945 - 1970
PCBs in Taiwan, 1979
6. List of proven & suspected EDs
Pesticides Drugs
Organochlorines DES
Pyrethroids The Pill
Diflubenzuron
Trainees
EBDC fungicides
Vinclozolin
Unintentional contaminants
dioxins
polycyclic aromatic hydrocarbons (PAHs)
42
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Natural compounds
genistin
zearlemone
soy-based phytoestrogens
Industrial Chemicals
alkyl phenol polyethoxylates (APES)
alkylphenols
- detergents, toiletries
bisphenyl A (BPA)
- dental, beverage containers coating in cans
butylated hydroxy anisole (BHA)
- preservatives in food
phthalates
- vinyl floors, adhesives, packaging
PCBs - electrical transformers
7. What is not known about EDs?
what is/is not an ED
concentration needed to affect humans
43
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- difference in sensitivity
- timing of exposure
- multi generational effects
cumulative versus synergistic
- 1996 Tulane study
level of human exposure
8. EDs and legislation
FQPA and SDWA (safe drinking water act) both require a system of evaluating the chemicals
we're manufacturing
both require testing
August 1999 deadline
Endocrine Disrupter Screening & Testing Advisory Committee (EDSTAC)
recommendations finalized in August 1998
estimate of 70,000 chemicals to evaluate
European Environmental Agency Weybridge Conference, 1996
"insufficient evidence to definitely establish a causal link" between health effects seen in humans
and chemical exposure.
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But...although our present knowledge about environmental endocrine disrupting agents
and reproduction is extremely limited, we know enough about adverse trends in reproductive
health to be concerned
9. EDSTAC
Industry, Government, Environmental, Public Health, Worker Safety, Academia
Charge: Develop consensus-based recommendations for evaluating human health effects
Broadened to include wildlife
Estrogens/Androgen/Thyroid
10 EDSTAC Recommendations
87,000 cpds
Look at the riskiest first using prescreening assays
Four Categories:
- tier one screening: insufficient data to classify prescreen
- tier two: data indicate endocrine effects; proceed to whole animal studies (includes
most pesticide active ingredients)
- risk assessment group: whole animal data already there; do risk assessment
- polymers: on hold - a lot of the EDs are linked to plastics
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11. Mv Questions/Concerns
In vitro screening assays: how does the data relate to whole animal exposure?
Effects in amphibians: while this is important in environmental risk, is this important in
human dietary exposure?
Even laboratory animals: is metabolism and hypothalamic/pituitary/sex organ or other
endocrine organ similar enough to be relevant?
Do we have scientifically acceptable methods to predict endocrine disruption from dietary
sources?
Reminder: you can disrupt the endocrine system by inducing liver enzymes without
actually interacting
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Briefing on Access To Pesticide Information
Claire Gesalman, EPA OPP Communications Branch
Following are some sources of information on pesticides at the Environmental Protection Agency
and U.S. Department of Agriculture.
EPA INFORMATION SOURCES
Office of Pesticide Programs (OPP) Public Docket
Maintains the official record of a wide variety of pesticide-related actions, including the publicly
released risk assessments and related documents for the organophosphates (OPs).
Located in Room 119, Crystal Mall 2, at 1921 Jefferson Davis Highway, Arlington, Virginia.
Open from 8:30 a.m to 4:00 p.m., Monday through Friday, except Federal holidays
Telephone number is 703-305-5805
OPP Web Site
On various links to many pages, obtain information on the OPs, the Tolerance Reassessment
Advisory Committee (TRAC), the Food Quality Protection Act (FQPA), the review of science
policies, the registration and reregistration of pesticides, and other topics.
www.epa.gov/pesticides/ -the OPP home page, includes links many pesticide topics.
www.epa.gov/pesticides/op/ -the OP tolerance reassessment and reregistration home page,
includes links to the OPP public docket for each OP for which documents have been released
for public review, a table summarizing review status for all the OPs, information on the review
process and how to become involved, background information on the OPs, and announcements
of technical briefings.
www.epa.gov/pesticides/trac/ -provides access to information on and agendas for the
Tolerance Reassessment Advisory Committee (TRAC), including the papers prepared for each
meeting.
www.epa.gov/pesticides/trac/science/ -provides access to the draft science policy documents
being released for public comment and the associated. Federal Register notice.
www.epa.gov/oppbeadl/matrices -Tables compiled by OPP to display crop-specific
information about the amount of each OP pesticide used, the critical pests it is used to combat,
and available information about regional differences in use patterns.
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USDA WEB SITES
The Office of Pest Management Policy serves to integrate the programs across six USDA
agencies related to pest management. The following sites provide a path to the pest management
programs of these agencies, or their search links, as well as the land-grant universities.
Office of Pest Management Polity (OPMP) - ipmwww.ncsu.edu/opmppiap -includes USDA's
crop profiles and other FQPA databases. The profiles are a resource for EPA in preparation of
risk assessments, reregistration eligibility documents and Section 18 exemptions. The profiles
also will aid USDA and others in targeting research and in developing risk mitigation plans and
transition strategies.
OPMP Core Group:
Agricultural Marketing Service- www.ams.usda.gov
ฆ Pesticide Data Program - www. ams. usda.gov/science/pdp/index. htm
ฆ Federal Pesticide Recordkeeping Program - www. ams. usda. gov/science/sdpr. htm
Agricultural Research Service- www.ars.usda.gov/
National Programs -www.nps.ars.usda.gov/
ฆ Animal Production, Product Value and Safety
Natural Resources and Sustainable Agricultural Systems
Crop Production, Product Value and Safety
Cooperative State Research, Education and Extension Service (CSREES) -
www. reeusda. gov/
Plant and Animal Systems- www.reeusda.gov/pas/programs/programs.htm
(IPM, Interregional Projects-IR-4, Pesticide Impact Project, Pesticide Safety Education)
Eanswers: Your Extension Information Source - www.e-answers.org/
Economic Research Service (ERS) www.econ.ag.gov/
Forest Service- www.fs.fed.us/
National Agricultural Statistics Service (NASS) - www.usda.gov/nass/
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Appendix II
Slides for David Miller's Briefing
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Risk, Data Needs, and
Assessment
Conference on the
Food Quality Protection Act
EPA Region I
Westford, MA
March 3, 1999
erview of Talk
ฆ iFQPA and Science Impacts
a
-'.Aggregate Exposure
( Risk Equation
hazard identification/dose response
exposure
- residue chemistry
- food consumption
DEEM Software
Tiered Approach to Risk Assessment
Risk Refinement
od Quality Protection Act
Amends FIFRA and FFDCA
Enacted into law August 3,1996
In force immediately
Requires that 9000 tolerances be
reassessed
1
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ijor Science Impacts of FQPA
Additional 10-fold Safety Factor to Account
;3 for Special Sensitivity of Infants and Children
~ ~ Development of Testing and Screening for
Endocnne Disruptors
"Aggregate" Exposure across pathways
"Cumulative" Exposure across chemicals
e- and Post-FQPA Pathway
essment
Dietary
Drinking
-jWater
Residential
Occupational
Pre-
F
-------
The Risk Equation
Specifically,
RISK (as %RfD) = Exposure (mq/kq bwt/day)
RfD (mg/kg bwt/day)
where
|g Exposure calculated from pesticide residues
and food consumption
and
RfD determined from toxicology studies
etary Risk Assessments
Two types of dietary risk assessments
ฆ Chronic
- assesses risk associated with long-term (years)
exposures
- uses average residues and average
consumption
ฆ Acute.
- assesses risk associated with short-term (1
day) exposure
- uses either
high-end residue concentrations (deterministic)
entire range of residues (probabilistic)
Hazard Identification/
Dose Response
The toxicology part of the
risk equation
3
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Ixicity Studies
ฆ Studies are used to determine toxicity
endpoints and their associated doses
Example:
for acute toxicity
- toxicity endpant - chohnesterase inhibition
- associated dose -0 40 mg/kg bwtfday
ฆ for chronic toxicity
- toxicity endpomt ~ liver hypertrophy
- associated dose = 0 20 mg/kg bwt/day
Studies used to calculate RfD
RfD based on No Observed Adverse Effect Level (NOAEL)
safety factors applied to NOAEL to obtain RfD
quired Toxicity Studies
acute
subchronic
subchronic dermal
chronic
chronic/oncogenicity
metabolism
ฆ developmental
m 2-generation.
reproductive
m acute neurotoxicity
ฆ subchronic
neurotoxicity
Residue Chemistry
the first half of the exposure part
of the risk equation
4
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HHVo Key Residue Chemistry
mB&nsiderations
What is there?
Nature of the Residue (Metabolism
Studies)
ฆ . plants
lฎ, - animals
ฆ How much is there?
'& Magnitude of the residue
if - plants (crop field trials)
ฆJ: - animals (feeding studies)
13
xv much is there? (plants)
Apply pesticide at maximum label rate and
harvest at minimum post-harvest interval
Number of trials dependent on where crop is
grown
Trials must be geographically representative
of where crop is grown
Crops analyzed for compounds of
toxicological concern
Consumption Data
the second half of the exposure
part of the risk equation
H
5
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nsumption Data
part of Dietary Exposure Evaluation Model
(DEEM) software
derived from USDA's Continuing Survey of
Food Intake for Individuals (CSFII)
1989-91
fei 1994-96
^ ฆ statistically representative of consumption
-1 practices of U S. population
ฃ'
age, sex, ethnicity/race, season, region of country,
t; etc
ft:
%:ฆ
B The Dietary Exposure
[1Evaluation Model (DEEM)
software
putting it all together
17
ZEM Software
v -
1::
inputs include
toxicity information (RfD)
exposure information
- crop field trial residues
-food consumption (from USDA's CSFII)
Output includes
exposure levels (mg/kg bwt/day)
risk (%RfD occupied)
If exposure exceeds "safe" dose, use tiered
approach to refine crop field tnal residue
inputs
-------
'"Tiered Approach for Dietary
Exposure Assessment
progressing from worst-case to
real-world assumptions
red Approach to Dietary
ฆosure Assessment (Food)
HED uses a tiered approach to incorporate
residue data to conserve resources
There are currently four tiers
Tienng begins with simple worst-case
assumptions using real residue data and
progresses to more refined assumptons and
exposure estimates
FQPA will require further refinement of
residue data on foods
erview of Tiering Process for
od
Chronic :ฃ
Consumption Residue
Tier
Acute
Consumption Residue
PDP MHS
CT
FUnJiii|
R<-
-------
es of Studies for Risk
inement
bridging studies
residue decline studies
-~-'m residue degradation studies
m cooking and processing studies
ฆ market basket studies
idging Studies
recognize that not all
j?s crops are treated at
maximum rate
'bridge' pesticide
residue data between
maximum application
rate and range of more
typical rates
permits refinement of
exposure estimate by
incorporating residues
resulting from full range
of application rates
sidue Decline Studies
n recognize that not all
v crops are harvested at
minimum PHI
ฆ used to establish
relationship between
PHI and resulting
residue level
ฆ permits refinement of
exposure estimate by
incorporating residues
from full range of PHI'S
8
-------
sidue Degradation Studies
recognize that crops
ai can be stored for
relatively long periods
over which residues can
decline
permits refinement of
exposure estimate by
incorporating residues
from full range of
storage times
oking and Processing Studies
ฆ Home Processing and Cooking
ฆ recognize that some foods are cooked or
otherwise processed prior to consumption
-eg. potatoes are cooked, oranges are peeled
Commercial Processing
recognize that commercial processing can reduce
residues in commercial foods substantially
-eg canned and frozen fruits and vegetables
rket Basket Surveys
intended to reflect most closely actual
pesticide exposures
m samples collected on single serving basis
(e.g., single apple)
m collection points are commercial retail
establishments
m rigorous statistical design
17
9
-------
Risk Refinement:
Coming documents
m Scheduled FR Publication (March, 1999)
5 "Data for Refining Anticipated Residue Estimates
% Used in Dietary Risk Assessment tor Organo-
Phosphate Pesticides'
m Guidance documents under development
'Guidance for the Conduct of Bridging Studies for
Use in Probabilistic Risk Assessment'
'Guidance for the Conduct of Residue Decline
Studies for Use in Probabilistic Risk Assessment"
nclusions
FQPA has had major impacts on the way
exposures are assessed and risks are
calculated at the Agency
Risk is calculated from an equation which
combines toxicity information and exposure
information Exposure information is derived
from pesticide residue levels in food and
amounts of these foods consumed
nclusions
nt'd)
ป The Agency uses a tiering system for food
]' exposure which begin with worst-case
, \ assumptions and progress through to more
refined assumptions
m EPA anticipates that refinements beyond
those routinely provided to the Agency will be
key to developing more realistic estimates for
exposures for food
30
10
-------
Appendix III
Slides for Evelyn Washington's Briefing
-------
Impacts of FQPA on EPAs
Drinking Water Program
Conference on the Food Quality
Protection Act
Evelyn Washington
Associate Chief, Targeting and Analysis Branch
Office of Ground Water and Drinking Water
Topics to Be Covered
~ Highlights of FQPA
~Highlights of 5DWA
~Common elements
~Improved coordination
-------
FQPA (Food Quality Protection Act)
~ August 3, 1996.
~ Health-based safety standard, aggregate
risk
~ Special provisions for infants & children
~ Better information for consumers, including
the "right to know"
~ Tolerance reevaluation, reregistration
~ Limitations on benefits considerations
~ Provisions for endocrine testing
SDWA (Safe Drinking Water Act)
~ August 6, 1996.
~ New, stronger approaches to prevent
contamination
~ Better information for consumers, "right to
know"
~ Regulatory improvements, better science,
prioritization, improved risk assessment
~ Drinking water state revolving fund
~ Provisions for endocrine testing
2
-------
Common Elements
~Pesticides and degradation products
~Improved risk assessment, better
science
~ Special consideration of infants &
children
~"Right to know"
Improved Coordination
~ 5 goals identified
~ Common human health risk assessment
methods
~ Common conclusions about the hazard,
occurrence
~ Common priorities for monitoring, regulation
~ Common science policy
~ Coordinated public policy on modifying
drinking water standards vs. Use restrictions
3
-------
Agreements
~Pesticide program's hazard
assessments will be used by drinking
water program
~ Develop common approaches to risk
assessment where appropriate
~ Share data on pesticide occurrence
~Identify common priorities
~ Cross-program involvement on science
policy
Agreements, Continued
~ Overf lowing "risk cup"
~ Overarching policy issue
~ Determine what the agency should do from a
regulatory perspective
~ Ecological risk assessment
~ Common assessment methods
~ Fish action levels, fish consumption
-------
Making the Agreements Work
~ Steering committee
~ Develop options for consideration
~ Management decisions
~Interest from upper management
~ Stakeholder involvement
-------
Recap of the Food Quality Protection Act Conference that was helded on March 3, 1999
at the Westford Regency, Westford, MA
Registration - we had about 85 registration which(which includes 9 speakers and walk-ins), with
14 no shows
For the total of 71 attending, out the the 71 attending 49 turned in a
Evaluation sheets -
State - 20, Federal Gvt - 9, Col /Unv - 8, other - 12(l-city Gvt, 1- High
School, 6 - farm bureau, growers, 1 - Structual Pest. Control, 1- Commidity
Assoc., 1 -private consultant, 1 - trade assoc )
How did they hear about the conference - 20 came as the results of direct mail, 9 - saw it on
the internet, 9 - received calls from EPA, 9 other -4 from coworkers, 3 - meetings, 1 - Student
newsletter, 1 - fax
Rating of conference Very useful Useful Not useful
Statusof FQPA Implementation
22
18
1
Risk,Data Needs & Assement
25
12
1
Panel Discussion
11
23
4
Outeach of FQPA issues
7
10
->
Data Requirements
14
15
1
The Risk Cup
16
15
6
Endocrine Disruptors
10
7
6
General Comments
States - Very informative, learned a lot of things I did not kown
Any future meetings should include or involve panel discussion particupation
from the reulated community (growers, applicators, chemical registrants)
Would have been nice to have included a copy of the Act in the package
Appreciated the information, very helpful after reading and trying to understand
FQPA on my own, have m e in depth discussion, also the panel discussion was
Very good but perhaps include a grower or someone directly effected on panel.
Information was very good . The rule is unworkable and I can't see how it can
ever work. Note by RISK CUP which was marked 1 - useful if only because it
showed how the rule can not work in practical application
Overall conference was very good, still don't know how the rule works, We need
more information from EPA
-------
This meeting was very well organized and informative Beside PANEL
DISCUSSION which was marked 3 was - it was interesting to get a synopsis of
what different agencies purpose are
Colleges/University
Well done
Some decent summaries but remarkbly dull presentations
Need More tine for discussions in the morning
Shoud have a meeting of this sort every other year for an update on how
Things are progressing at EPA and the problems occurring for those affected
FQPA, so EPA hears these concerns Good meeting
Others
With proceeding, send out a glossary of terms etc
Good Sessions -
Speakers were good & well organized
Good sources of rmore information
Some of speakers seem to push through visuals
Concerned The FQPA will elimate the minor suses of pesticides due to economies
More comm. is needed by all parties invloved, more philocophical discussion is
needed in theis area
I would first like to find ot what is the problem
Federal
Place conference notifications in training data base
Would have been better to have someone fromm OPP who does risk assessment
Conduct "the risk cup" breakout session There were lots of questions.
Talk by Region 4 staff didn't seem relevant to our region, although she was GREAT
in the Risk Cup Session
-------
Conference was very helpful in understanding all the issues surrounding the FQPA
And implementation
Thanks
-------
Appendix IV
Speaker Bios
-------
SPEAKER AND PANEL MEMBER BIOGRAPHIES
SPEAKERS
Mindy Lubber
EPA Region I
Mindy is the Deputy Regional Administrator for EPA-Region I, New England and is responsible
for the administration and management of the 800-person, $450 million budget office as well as
for overseeing the programmatic policy and legal work of the region. She personally directs the
region's external affairs programs, which includes media relations and intergovernmental affairs.
She's a member of the Region I senior management council. In the past she served as president of
Green Century Capital Management, and investment firm dedicated to investing in
environmentally responsible companies which donates all of its net revenues to supporting
environmental advocacy. Mindy was a senior advisor to former Massachusetts Governor Michael
Dukakis and was part of the team that ran his presidential campaign. She's held various positions
with the Massachusetts Public Interest Research Group including Chairwoman of the Board of
Directors and Legislative Directors. Mindy holds a bachelor's and master's in business
administration and a law degree. She's a member of the Massachusetts Bar.
Jim Jones
EPA Office of Pesticide Programs
Jim is the Director of the Registration Division at EPA headquarters. Prior to that he served as the
Associate Director of the Field and External Afiairs Division and as the chief of the Registration
Support Branch in OPP. Jim has been with EPA for 11 years. He has a Masters in Economics
from the University of California at Santa Barbara and a Bachelors in Economics from the
University of Maryland at College Park.
David Miller
EPA Office of Pesticide Programs
David has been with the Health Effects Division for six years, working as a residue chemist and
risk assessor. The focus of his current work at EPA is probabilistic risk assessments. Prior to his
agency employment he was a sanitary engineer in the Peace Corps, assigned to the Ecuadorian
Ministry of Public Health. He was also an associate engineer at a health and environmental
sciences consulting firm in Arlington, Virginia. HE received his bachelor's degree from the
University of Pennsylvania and master's of science and master's of public health degrees from
Virginia Tech and the University of Michigan, respectively. He's a commissioned officer in the
U.S. Public Health Service.
-------
PANEL MEMBERS
Robert Koethe
EPA Region I
Rob is the regional pesticide expert in the EPA-New England Office. IN that role, he provides
technical support and guidance to the New England State pesticide regulatory programs. Prior to
coining to work for EPA, Rob worked for eight years as the Integrated Pest Management advisor
with the University of Illinois Cooperative Extension Service. Rob has a B.A. in biology from
Gettysburg College, an M.S. from Penn State University, and his Ph.D. from North Carolina State
University.
Lora Lee Schroeder
Life Scientist, Pesticide Section, EPA Region 4
Lora Lee is in charge of the Region 4 Agricultural Initiative, which involves emphasizing
Integrated Pest Management, and the Region 4 Stewardship program. She served as a state
representative for AAPCO on the TRAC committee while she was in her previous position as
Pesticide Division Director of the Georgia Department of Agriculture. Ms. Schroeder has a
Masters in Plant Protection & Pest Management and a Bachelors in Horticulture, both from the
University of Georgia.
Evelyn Washington
EPA Office of Groundwater and Drinking Water
Evelyn is the Associate Chief of the Targeting and Analysis Branch (TAB) within the Office of
Groundwater and Drinking Water. TAB is responsible for the development of regulatory tools
such as cost-benefit analyses and lists of treatment technologies as well as the development of
contaminant regulations such as arsenic and radon. She previously served as team leader for the
Contaminant Identification and Selection Team. Ms. Washington is a chemical engineer by
training and began her career at EPA in 1988. She received her bachelor's degree in Chemical
Engineering from the University of Maryland, College Park. Prior to EPA, she worked for the
U.S. Department of Navy.
Lebelle Hicks
Pesticide Toxicologist for Maine Department of Agriculture
Lebelle volunteered to lead the breakout session on endocrine disruptors when Christine DiFonzo
was unable to come. Lebelle is the Pesticide Toxicologist for the Maine Department of
Agriculture, Board of Pesticides ControL She was previously the Acting State Toxicologist for
the Maine Department of Human Health and the Massachusetts Pesticide Bureau. Lebelle has a
Ph.D. in Food and Nutrition Sciences from the University of Maine, an M.S. in
-------
Biology/Toxicology from Northeastern University, and a B.S. in Biology from Fitchburg State
College. She is a Diplomat of the American Board of Toxicology.
-------
Appendix V
Conference Evaluations
-------
Conference Evaluation
Location
Westford Regency, Westford, MA
Registration
85 registered including speakers, walk-ins, and no-shows (14)
Evaluation Summary
Of the 71 attendees 49 turned in evaluation sheets. A summary of the evaluation follows:
Affiliation
Government - State (20), Federal (9), City (1)
Academia - Col./Univ. (8), high school (1)
Agricultural interests including growers and farm bureau (6)
Structural Pest. Control (1),
Other - Commodity group (1), private consultant (1), trade association (1)
How did attendees hear about the conference
Direct mail (20),
Internet (9),
Direct contact - telephone calls (9),
Coworkers (4),
Meetings (3),
Student newsletter (1),
Fax (1)
Rating of Conference
Very useful
Useful
Not Useful
Status of FQPA Implementation
22
18
1
Risk, Data Needs & Assessment
25
12
1
Panel Discussion
11
23
4
Outreach on FQPA issues
7
10
3
Data Requirements
14
15
1
The Risk Cup
16
15
6
Endocrine Disruptors
10
7
6
-------
Summary of Specific Comments bv Affiliation:
States
Very informative, learned a lot of things I did not know
Any future meetings should include or involve panel discussion participation from the
regulated community (growers, applicators, chemical registrants)
Would have been nice to have included a copy of the Act in the package
Appreciated the information, very helpful after reading and trying to understand FQPA on
my own, have more in depth discussion; also the panel discussion was very god, but
perhaps include a grower or someone directly effected on panel.
Information was very good. The rule is unworkable and I can't see how it can ever work.
Note by RISK CUP which was marked 1 - useful if only because it showed how the rule
cannot work in practical application
Overall conference was very good, still don't know how the rule works, We need more
information from EPA.
This meeting was very well organized and informative. Beside PANEL DISCUSSION
[which marked 3 - not useful] was a notation stating that "it was interesting to get a
synopsis of what different agencies purposes are"
Federal
Place conference notations in training data base.
Would have been better to have someone from OPP [Office of Pesticide Programs] who
does risk assessment conduct "the risk cup" breakout session. There were lots of
questions.
Talk by Region 4 staff didn't seem relevant to our region, although she was GREAT in the
Risk Cup Session.
Conference was very helpful in understanding all the issues surrounding the FQPA and
its implementation.
Thanks!
Colleges and Universities
Well done!
Some decent summaries but remarkably dull presentations.
Need More time for discussions in the morning.
Should have a meeting of this sort every other year for an update on how
Things are progressing at EPA and the problems occurring for those affected by FQPA,
so EPA hears these concerns. Good meeting.
Others
With proceeding, send out a glossary of terms, etc.
Good sessions
Speakers were good & well organized
-------
Good sources of more information
Some of speakers seem to push through visuals
Concerned The FQPA will eliminate the minor uses of pesticides due to economies
More communication is needed by all parties involved, more philosophical discussion
needed in this area.
I would first like to find out what is the problem.
-------
Appendix VT
Dr. Goldman's Q & A
-------
Meeting on FQPA with Dr. Goldman, April 27,1998
The meeting was attended by several Region I staff, SLA's, representatives of several commodity
groups, two state IPM coordinators, and two Tuft's University people (see list).
Dr. Goldman made a few comments on the current status of FQPA, including the fact that much
of the current work is being done by advisory committees; she specifically mentioned the
Tolerance Assessment Advisory Committee (TRAC) which was just formed. She said no
decisions have been made yet, and added that the Wall St. Journal article on the cancellation of
organophosphates was totally incorrect.
Stakeholder Questions and Dr. Goldman's Answers:
Q: Rich Bonnano of NE Vegetables - how serious are you about actual use data? He said he
asked this because growers were having a difficult time finding out what data was needed, and in
what format.
A: Very serious. She acknowledged the confusion about the data and format and said they were
working hard to get that straightened out.
Q: Follow up by Rich - How can we take a pro-active role to protect minor use crops?
A: This is tough to do; we need to involve the growers. Currently we are groping in the dark.
Another aspect of this is, what are the alternatives?
Q: Jere Downing of the Cranberry Institute - are we behind the 8 ball already? We don't know
what data to gather.
A: We need to be clear about the data desired, and the format in which it is presented.
Comment: Dave Bell of the Blueberry Commission - we don't know what data to collect, or how
to present it to make it solid.
A: We're thinking in terms of transition: We need to achieve the goal of FQPA, but in a way that
involves the stakeholders and allows a transition.
Q: Michael Corey of the Maine Potato Board - Has EPA determined the size of the risk cap for
various pesticides?
A: No, the Institute of Life Sciences is working on that.
Q: Michael Corey - If a chemical is registered for several crops, how will the allowable use be
determined for each?
A: The risk may be different in different regions for the same crop, as well as for different crops.
Comment: Dick Berman of Waltham Chemical - Our concern is that most of the pesticides we use
are also used in agriculture.
A: I understand that.
-------
Q: Jere Downing - There are two key issues: time and a clear process. Another issue is
confidentiality (this is a major issue with food companies).
A: There is a conflict between the desired transparency and confidentiality. I hope the companies
can back off from their confidentiality requirement after the first year or so a product is on the
market.
Q: Follow up, Jere Downing - adverse publicity is a concern; e.g., when the Environmental
Working Group took PDP data, calculated it in their own way, and published an article which
included distorted information.
A: Fear should not be a motivation. EWG did a crude assessment, not the way EPA would have
done it.
Comment: Bill Coli, U. Massachusetts IPM Specialist - A concern regarding residue data is that
even if a report showing zero residue is sent in, EPA will use half of the detect limit.
A: We discussed "non-detects" and got some good ideas; there is a support for using zero detects.
Q: Molly Anderson of Tufts University - How will the tolerance assessment advisory committee
be constituted?
A: AT a very high level with people who are strongly networked with stakeholders. It will include
about 40 people and include pest control company reps, farmer groups, structural pest control
industry reps, academics, public health folks, public interest groups, and reps from state and local
government.
Q: Follow up, Molly Anderson - What will be the process for public involvement?
A: All meetings will be held in public; a web site will be set up; and there will be a public comment
period on each key decision.
Q: Debra VanderBeck of ACPA - Will the group have decision-making authority?
A: No, it is strictly advisory; decisions will be made by EPA.
Q: ? - What is your best guess on when the total program will be finished?
A: The TRAC will be done in August, 1998. We will then put the results in an FRN to obtain
public comment; that's when you'll see our blueprint.
Q: ? - Will there be a blanket cancellation of organophosphates?
A: No.
Q: ? - I've been hearing the organophosphate risk cup is overflowing ~ is there any evidence of
illness caused by exposure to organophosphates?
A: We don't know. There is a program tracking lead in blood, and they've looked for traces of
organophosphates. We need to find out what is actually in people as well as in the food.
-------
Dr. Goldman Meeting Attendees
EPA Region I
Marv Rosenstein - Associate Director, Pesticides, Toxics and Radiation
Rob Koethe - Pesticide Specialist
Andy Triolo - Pesticide Specialist
Allan Christensen - Senior Environmental Enrollee
State Lead Agencies
Connecticut - Brad Robinson
Massachusetts - Brad Mitchell, Lee Corte-Real, David Sheldon
Also Commissioner of Agriculture - Jay Healey
Rhode Island DEP - Elizabeth Lopes-Duguay
Vermont - Phil Benedict, Jim Leland
IPM Coordinators
Massachusetts - Bill Coli, Natalia Clifton, Dave Ferro
New Hampshire - Alan Eaton
Commodity groups and others
Dick Berman - Waltham Chemical
Rich Bonnano - NE Vegetables and Berries
Jere Downing - Cranberry Institute
Molly Andersen - Tufts University
David Bell - Wild Blueberry Commission of Maine
Robby Hubley - MA Audubon
Michael - Maine Potato Board
David McCarthy - Cranberry Grower
Debra Vanderbeek - NE Council for Plant Protection, & ACPA
Kelly M organ - Tufts University/Graduate Student
-------
Appendix 7
Attendee List
-------
EPA - Conference on Food Quality Protection Act
Westford, MA
March 3, 1999
Participant List
Rob Adler Glenn Ahrens
US EPA Region I Pinkerton Academy
1 Congress Street, Suite 1100, CRI 5 Pinkerton Street
Boston, MA 02114 Derry, NH 03038
Phone: (617) 918-1396 Phone: (603) 437 5200
Fax: (617)918-2064 Fax:
Ted St. Amand Steven E. Antunes-Kenyon
Atlantic Exterminating Company, Inc. Pesticide Bureau
1903 Portland Road DFA
Arundel, ME 04046 100 Cambridge Street
Phone: (207) 985-7716 Boston, MA 02202
Fax: (207) 985-8565 Phone: (617) 727-3020
Fax: (617) 727-7235
Kenneth D. Ayar
Division of Agriculture
Rl DEM
235 Promenade Street
Providence, Rl 02908
Phone:(401)222-2781
Fax: (401)222-6047
Candace Bartholomew
University of Connecticut
CES
1800 Asylum Ave.
West Hartford, CT 06117
Phone: (860) 570-9067
Fax: (860) 570-9008
Lorraine P. Berkett Richard C. Berman
University of Vermont Waltham Chemical Company
Plant & Soil Science Dept. Hills Build 817 Moody Street
Burlington, VT 05405 Waltham, MA 02453
Phone: (802) 656-0972 Phone: (781) 893-1810
Fax: (802)656-4656 Fax: (781)893-4860
David G. Bishop Bridgette Braley
Mass. Fruit Growers Association Nashoba Board of Health
Wellsmount Orchards 30 Central Ave
106 Bardswell Ferry Road Ayer, MA 01452
Shelburne, MA 01370 Phone: (978) 772-3335
Phone:(413)625-9568 Fax: (978) 772^947
Fax: (413)625-9568
-------
William E. Broderick Frank Caruso
Sunny Crest Orchards University of Massachusetts
84 Hawkins Lane Cranberry Experimental Station
Sterling, MA 01564 P. O. Box 569
Phone: (978) 422-6687 E. Wareham, MA 02538
Fax: (978) 422-0542 Phone: (508) 295-2272 x 18
Fax: (508)295-6387
Wendy Chapley
New Dept. of Agriculture
Markets & Food
25 Capitol Street
Concord, NH 03301
Phone: (603) 271-3550
Fax: (603)271-1109
William M. Coli
U Mass IPM Program
Engineering Building
Amherst, MA 01003
Phone: (413) 545-1051
Fax: (413)545-5858
Lee Corte-Reai
Massachusetts DFA
100 Cambridge Street
Boston, MA 02726
Phone: (617) 727-3020 x 126
Fax: (617) 727-7238
Joanne Cummings
Vermont Department of Agriculture
116 State Street
Montpelier, VT 05620
Phone: (802) 828-2431
Fax: (802)828-2361
Larry Davis
Environmental Health and Safety
N 414 Merrill Science
Amherst, MA 01003
Phone: (413) 545-2680
Fax: (413)545-2600
Jere Downing
Cranberry Institute
266 Main Street
Wareham, MA 02571
Phone: (508) 295-4132
Fax: (508)291-1511
John Dreisig Richard T. Dyer
Dept. of Health & Human Services Colonial Pest Control
NH 32 Lake Street
6 Hazen Drive Worcester, MA 01604
Concord, NH 03301 Phone: (508) 792-1900
Phone:(603)271-4664 Fax: (508) 792-1906
Fax: (603)271-3991
Heather Faubert
University of Rhode Island
120 Greenhouses, URI
Kingston, Rl 02881
Phone:(401)874-2750
Fax: (401)872-5296
Mary Jo Feuerbach
US EPA Region I
One Congress Street
Boston, MA 02114-2023
Phone: (617)918-1578
Fax: (617)918-1505
-------
Bruce H. Gresczyk
CT Department of Agriculture
765 Asylum Avenue
Hartford, CT 06105
Phone: (860) 713-2500
Fax: (860) 713-2514
Gilbert Griggs
Griggs Farm
599 Boston Road
Billerica, MA 01821-3714
Phone: (978) 667-9111
Fax:
William Griggs
Griggs Farm
599 Boston Road
Billerica, MA 01821-3714
Phone: (978) 667-9111
Fax:
Ann Hazelrigg
University of Vermont
Plant & Soil Science Dept.,
Hills Building
Burlington, VT 05405
Phone: (807) 656-0493
Fax: (807)656-4656
Greg Heller
US EPA
60 Westview Street
Lexington, MA 02421
Phone: (781) 860-4677
Fax: (781) 860-4397
Lebelle Hicks
Maine Board of Pesticides Control
28 State House Station
Augusta, ME 04333
Phone: (207) 287-2731
Fax: (207) 287-7548
Martha Kessler
BNA, Inc.
275 Island Road
Millis, MA 02054
Phone: (508)376-1147
Fax: (508)-376-4709
Elaine Krueger
MA Department of Public Health
250 Washington Street, 7th Floor
Boston, MA 02108
Phone: (617) 624-5757
Fax: (617)624-5757
Kathleen Leahy
Policies - Cardboard Management
364 Wilson Hill Road
Colrain, MA 01540
Phone: (413) 624-5104
Fax: (413)624-5104
Mark S. Leahy
Colonial Pest Control
32 Lake Avenue
Worcester, MA 01604
Phone: (508) 792-1900
Fax: (508) 792-1906
Ronald Lee
Rl Dept. of Health
Office of Food Protection
3 Capitol Hill, Room 203
Providence, Rl 02904
Phone:(401)222-2749
Fax: (401)222-4775
Elizabeth M. Lopez-Duguay
DEM - Division of Agriculture
235 Promenade Street
Providence, Rl 02908
Phone:(401)222-2781
Fax: (401)222-6047
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Lorraine Los
University of Connecticut
Department of Plant Science U-67,
1376 Storrs Road
Storrs, CT 06269
Phone: (860) 486-6449
Fax: (860)486-0682
Annete MacMilan
Vermont Department of Agriculture
116 State Street
Montpelier, VT 05620
Phone: (802) 828-2431
Fax: (802)828-2361
Andrew S. Martin
Honey Pot Hill Orchards
144 Sudbury Road
Stow, MA 01775
Phone: (978)562-5225
Fax:
Frank Mattheson
MASS Farm Bureau
591 Great Road
Littleton, MA 01460
Phone: (978) 486-3824
Fax: (978)486-1028
Helen T. McCarthy
Dept. of Health Laboratory
Rl
50 Orms Street
Providence, Rl 02904
Phone:(401)222-5599
Fax: (401)222-6985
Laura McCarthy
Gloucester Health Department
22 Poplar Street
Gloucester, MA 01966
Phone: (978) 281-9771
Fax: (978)281-9729
Murray L. McKay
NH Dept. of Agriculture
Markets & Food
P. O. Box 2042
Concord, NH 03302
Phone: (603) 271-3550
Fax: (603)271-1109
Brad Mitchell
Department of Food & Agriculture
100 Cambridge Street
Boston, MA 02202
Phone: (617) 727-3020 x 149
Fax:
Kelly Morgan Glenn Morin
Tufts University New England Fruit Consultants
Schl. of Nutrition Science & Policy 66 Taylor Hill Road
27 Easton Street Montague, MA 01351
Winchester, MA 01890 Phone: (413) 367-9578
Phone: (781) 729-2756 Fax: (413) 367-0373
Fax:
Barbara Naess Eugene Pepper
EPA Region V Pesticide Program DEM - Division of Agriculture
77 West Jackson Street, 8th Floor 235 Promenade Street
Chicago, IL 60604 Providence, Rl 02908
Phone: (312) 353-2192 Phone: (401) 222-2781
Fax: (312) 353-4788 Fax: (401) 222-6047
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David Rice
Grande Hill Farm LLC
81 Perkins Road
Madbury, NH 03820
Phone: (603) 743-0193
Fax:
Don Rivard
NE Pest Control Association
177 Second Avenue
Waltham, MA 02451-0859
Phone: (781)899-5843
Fax: (781)642-0693
Bradford Robinson
DEP
79 Elm Street
Hartford, CT 06106
Phone: (860) 424-3329
Fax: (860)424-4060
Marvin Rosenstein
US EPA Region I
1 Congress Street
Boston, MA 02114
Phone: (617)918-1622
Fax:
Hilary Sandler Kimberly A. Seita
UMASS Cranberry Experiment Station DEM - Agriculture
PO Box 569 235 Promenade Street
East Wareham, MA 02538 Providence, Rl 02908
Phone: (508) 295-2212 Phone: (401) 222-2781
Fax:(508)295-6387 Fax:(401)222-6047
Donald Shields Judith A. Singer
Department of Agriculture - CT Connecticut DEP
765 Asylum Ave 79 Elm Street
Hartford, CT 06105 Hartford, CT 06106
Phone: (860) 713-2508 Phone: (860) 424-5326
Fax: Fax: (860)424-4060
Karen G. Soper
Rl Dept Of Health, Pesticide Lab
50 Orms Street
Providence, Rl 02904
Phone: (401)222-5540
Fax: (401)222-6985
Alfred j. Sorensen
Environmental Health & Safety
UMASS - Amherst
15 Frost Lane
Amherst, MA 01003
Phone: (413) 545-2682
Fax: (413)545-2600
William Stamp III
Rl Farm Bureau
201 Comstock Parkway
Cranston, Rl 02921
Phone:(401)946-8589
Fax: (401) 946-9757
William Stamp Jr.
Rl Farm Bureau
201 Comstock Parkway
Cranston, Rl 02921
Phone:(401)946-8539
Fax: (401)946-9752
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Paul Tierney
Food Protection Program
MA - Dept. of Food & Drug
305 South Street
Jamaica Plain, MA 02130
Phone: (617) 983-6760
Fax: (617) 983-6770
Maurice Tougas
Massachusetts Pesticide Board
246 Ball Street
Northboro, MA 01532
Phone: (508) 393-9734
Fax: (508)393-6400
Andrew Triolo
US EPA - Region I
One Congress Street
Boston, MA 02114-2023
Phone: (617) 918-1634
Fax: (617)918-1505
Herman R. Weingart Jr.
Pesticide Program
Connecticut - DEP
76 Elm Street
Hartford, CT 06106
Phone: (860) 424-3325
Fax: (860)424-4060
Frank Whitemore
Brookdale Fruit Farm Inc.
38 Broad Street, P. O. Box 3891
Hollis, NH 03049
Phone: (603) 465-2240
Fax: (603)465-3754
Robert A. Wolfe
NH Division of Pesticide Control
25 Capitol Street
Concord, NH 03302-2092
Phone: (603) 271-3695
Fax: (603)271-1109
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