[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
THE STATUS OF IMPLEMENTATION OF THE FOOD QUALITY PROTECTION ACT OF 1996
=======================================================================
HEARING
before the
SUBCOMMITTEE ON ENVIRONMENT AND HAZARDOUS MATERIALS
of the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
MARCH 25, 2002
__________
Serial No. 107-97
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
__________
79-462 U.S. GOVERNMENT PRINTING OFFICE
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COMMITTEE ON ENERGY AND COMMERCE
W.J. ``BILLY'' TAUZIN, Louisiana, Chairman
MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan
JOE BARTON, Texas HENRY A. WAXMAN, California
FRED UPTON, Michigan EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia SHERROD BROWN, Ohio
RICHARD BURR, North Carolina BART GORDON, Tennessee
ED WHITFIELD, Kentucky PETER DEUTSCH, Florida
GREG GANSKE, Iowa BOBBY L. RUSH, Illinois
CHARLIE NORWOOD, Georgia ANNA G. ESHOO, California
BARBARA CUBIN, Wyoming BART STUPAK, Michigan
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
HEATHER WILSON, New Mexico TOM SAWYER, Ohio
JOHN B. SHADEGG, Arizona ALBERT R. WYNN, Maryland
CHARLES ``CHIP'' PICKERING, GENE GREEN, Texas
Mississippi KAREN McCARTHY, Missouri
VITO FOSSELLA, New York TED STRICKLAND, Ohio
ROY BLUNT, Missouri DIANA DeGETTE, Colorado
TOM DAVIS, Virginia THOMAS M. BARRETT, Wisconsin
ED BRYANT, Tennessee BILL LUTHER, Minnesota
ROBERT L. EHRLICH, Jr., Maryland LOIS CAPPS, California
STEVE BUYER, Indiana MICHAEL F. DOYLE, Pennsylvania
GEORGE RADANOVICH, California CHRISTOPHER JOHN, Louisiana
CHARLES F. BASS, New Hampshire JANE HARMAN, California
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska
ERNIE FLETCHER, Kentucky
David V. Marventano, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Environment and Hazardous Materials
PAUL E. GILLMOR, Ohio, Chairman
JAMES C. GREENWOOD, Pennsylvania FRANK PALLONE, Jr., New Jersey
GREG GANSKE, Iowa EDOLPHUS TOWNS, New York
JOHN SHIMKUS, Illinois SHERROD BROWN, Ohio
(Vice Chairman) GENE GREEN, Texas
HEATHER WILSON, New Mexico KAREN McCARTHY, Missouri
VITO FOSSELLA, New York THOMAS M. BARRETT, Wisconsin
ROBERT L. EHRLICH, Jr., Maryland BILL LUTHER, Minnesota
STEVE BUYER, Indiana LOIS CAPPS, California
GEORGE RADANOVICH, California MICHAEL F. DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire JANE HARMAN, California
JOSEPH R. PITTS, Pennsylvania HENRY A. WAXMAN, California
MARY BONO, California EDWARD J. MARKEY, Massachusetts
GREG WALDEN, Oregon JOHN D. DINGELL, Michigan,
LEE TERRY, Nebraska (Ex Officio)
ERNIE FLETCHER, Oklahoma
W.J. ``BILLY'' TAUZIN, Louisiana
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Brown, Hon. Rodney J., Deputy Under Secretary, U.S.
Department of Agriculture.................................. 4
Marquette, Robert, President, Ram Exterminating on behalf of
The Ohio Pest Control Association.......................... 32
McClure, Terry, President, Ohio Farm Bureau Federation....... 19
Schmenk, Christiane W., Director, Environmental Stewardship
Team, The Scotts Company................................... 26
Sharp, Hon. Adam, Deputy Associate Administrator, Office of
Prevention Pesticides and Toxic Substances, U.S.
Environmental Protection Agency............................ 7
Zellers, Jeffrey, President, K.W. Zellers & Son.............. 36
Material submitted for the record by:
CropLife America, prepared statement of...................... 47
FQPA Implementation Working Group, prepared statement of..... 52
Redfern, Jane Forrest, Environmental Projects Director, Ohio
Citizen Action, prepared statement of...................... 55
(iii)
THE STATUS OF IMPLEMENTATION OF THE FOOD QUALITY PROTECTION ACT OF 1996
----------
MONDAY, MARCH 25, 2002
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Environment
and Hazardous Materials,
Bowling Green, OH.
The subcommittee met, pursuant to notice, at 10:21 a.m., in
the Commissioners' Hearing Room, Fifth floor, Wood County
Courthouse, 1 Courthouse Square, Bowling Green, Ohio, Hon. Paul
Gillmor (chairman) presiding.
Member present: Representative Gillmor.
Staff present: Amit Sachdev, majority counsel; Jerry Couri,
policy coordinator; Hollyn Kidd, legislative clerk; and John
Ford, minority counsel.
Mr. Gillmor. I will call our first panel which right now
consists of Dr. Brown. Would you come forward?
The subcommittee will now come to order and I want to
express my thanks to everyone who came here today, either to
testify or to lend support for those who are speaking or just
to get yourself better informed about the issues which are
surrounding the implementation of this very important food
safety law.
We do not have our witness from EPA yet because of the
weather. If they arrive, we will put them on the panel, or if
they get here later, we will take their testimony after we have
concluded the second panel. The weather, of course, is
something we cannot control. Congress is out of session this
week, so that gives us an opportunity to get around the
District and we have a full schedule of 4 days and nine
counties and now we have got this weather forecast for 3 days.
So maybe it will be three counties, I am not sure.
This is the first of what may be a series of field hearings
across the country on this and other health safety issues.
Before we get started with today's proceedings, I want to
express my gratitude to Wood County Commissioner Tim Brown and
to all of the County Commissioners for their hospitality. Jimmy
Carter, the President of the County Commissioners, is in the
back. Tim helped us secure the use of the facilities here and
Tim used to be on my staff, so I am glad to see that I still
know such an influential person.
I think it is fitting that we are in Ohio to discuss the
implementation of the Food Quality Protection Act. In our
state, really within the northwest corner of this state, we see
the nexus of the issues facing the application of this new law
and the many interests that are working to see that the final
regulations of this law are reasonable in their scope and
effective in their outcome.
Six years ago, back in 1996, I was a co-sponsor of a bill
that eventually became this law. The passage of the Food
Quality Protection Act was a significant legislative
achievement because it finally updated the Nation's food safety
laws to reflect the decades worth of advances in science,
medicine and agriculture. It was not a perfect bill by any
means, and of course hardly ever any legislation ever is. But
it did reflect a bipartisan compromise to establish a new risk
assessment standard of reasonable certainty of no harm.
Our committee still has work to go in order to ensure that
the statute is properly implemented. The goal today remains the
same as it was when our committee first passed this bill and
that is to ensure that the Act improves the safety of our food
supply, instills confidence in the food quality of the United
States and makes realistic risk-based demands on America's
farmers.
And as we approach the second major statutory deadline of
this Act, which comes on August 3 of this year, I am committed
to overseeing FQPA implementation and I intend to continue to
make it a priority of the Subcommittee of Environment and
Hazardous Material.
Since it has been some time now since the Food Quality
Protection Act was signed into law, I believe it is fair to
look at the progress and the practical effects of the law.
Although simply stated, the Food Quality Protection Act of 1996
amended Federal pesticide and food and drug laws by directing
the EPA to apply improved standards to evaluate the safety of
pesticides that are used on food crops including fruits,
vegetables and grain, the last 6 years have seen both the U.S.
EPA and the U.S. Department of Agriculture working hard to meet
the rigorous statutory deadlines and struggling to develop new
scientific models and methods for assessing pesticide risks.
The Food Quality Protection Act requires that EPA and USDA
re-evaluate the maximum safe level for pesticide residues on
food or tolerances by taking into consideration sensitivities
of infants and children and by using the best available
information to evaluate other important factors. In many
respects, this process is scientifically complex and is often
difficult for those of us who are non-scientists to follow.
Although my twin boys, who are five, are past the infant
stage, as a concerned father, I know that proper implementation
of FQPA is essential to dramatically impacting American farming
and consumer confidence in food safety.
We have a very distinguished panel of government witnesses
and Ohioans who are farmers, scientists, business people and
citizens whose lives, health and livelihoods are impacted by
the implementation of this Federal law. I look forward to
hearing their oral remarks and posing the kind of questions
that bill writers need to have for feedback from the law's
affected stakeholders.
At this point, I want to introduce some of the other people
up at this table so you know who they are. Jerry Couri, who is
policy coordinator to the Environment and Hazardous Materials
Subcommittee; Amit Sachdev, who is counsel to the full Energy
and Commerce Committee; John Ford, who is minority counsel to
the Energy and Commerce Committee; and Hollyn Kidd, who is our
legislative clerk.
[The prepared statement of Hon. Paul Gillmor follows:]
PREPARED STATEMENT OF HON. PAUL GILLMOR, A REPRESENTATIVE IN CONGRESS
FROM THE STATE OF OHIO
The Subcommittee will now come to order. I want to express my
thanks to everyone who has come here today, either to testify before
our committee, lend support to those speaking, or just to get yourself
better informed on the issues surrounding implementation of this
important food safety law.
Before we get going with today's proceedings, I also want to
acknowledge my gratitude to Wood County Commissioner Tim Brown. Tim
helped us secure use of the facilities here in the Courthouse, and
since he used to be on my staff, I am glad to be on good terms with
such an influential figure.
I believe it is fitting that we are in Ohio to discuss the
implementation of the Food Quality Protection Act. In our state, really
within the Northwestern corner of the state, we see the nexus of the
issues facing the application of this new law and the many interests
that are working to see that the final regulations of this law are
reasonable in their scope and effective in their outcome.
Six years ago, back in 1996, I was a cosponsor of the bill that
eventually became this law. The passage of the Food Quality Protection
Act was a significant legislative achievement because it finally
updated the nation's food safety laws to reflect decades-worth of
advances in science, medicine, and agriculture. It was not a perfect
bill, by any means--although what legislation ever is, but it did
reflect a bipartisan compromise to do away with the outdated Delaney
Clause's ``zero risk'' standard with a new risk assessment standard of
``reasonable certainty of no harm.'' Our Committee still has work to do
in order to ensure that the statute is properly implemented. The goal
today remains the same as it was when our Committee first passed this
bill: ensure that the Act improves the safety of our food supply,
instills confidence in the food quality of the United States, and makes
realistic, risk-based demands on America's farmers. As we approach the
second major statutory deadline of this Act on August 3, 2002, I am
committed to overseeing FQPA implementation and I intend to continue to
make it a priority for the Subcommittee on Environment and Hazardous
Materials.
Since it has been some time since FQPA was signed into law, I
believe it is fair to look at the progress and the practical effects of
the law. Although, simply stated, the Food Quality Protection Act of
1996 amended federal pesticide and food and drug laws by directing EPA
to apply improved standards to evaluate the safety of pesticides that
are used on food crops, including as fruits, vegetables and grains; the
last six years have seen both the U.S. Environmental Protection Agency
and the U.S. Department of Agriculture working hard to meet the
rigorous statutory deadlines and struggling to develop new scientific
models and methods for assessing pesticide risks.
FQPA requires EPA and USDA to reevaluate the maximum safe levels
for pesticide residues on foods, or ``tolerances,'' by taking into
consideration sensitivities of infants and children, and by using the
best available information to evaluate other important factors. In many
respects, this process is scientifically complex and is often difficult
for non-scientists to follow. Although my twin boys are well passed the
infant stage, as a concerned father, I know that proper implementation
of FQPA is essential to dramatically impacting American farming and
consumer confidence in food safety.
We have a very distinguished panel of government witnesses and
Ohioans who are farmers, scientists, business people and citizens whose
lives, health, and livelihoods are impacted by the implementation of
this Federal law. I look forward to hearing each of their oral remarks
and posing the kinds of questions that bill writers need to have
feedback on from the law's affected stakeholders.
Again, thank you all for coming.
Mr. Gillmor. Our first witness this morning is the
Honorable Rodney Brown, who is Deputy Under Secretary of the
United States Department of Agriculture from Washington. Dr.
Brown.
STATEMENT OF HON. RODNEY J. BROWN, DEPUTY UNDER SECRETARY, U.S.
DEPARTMENT OF AGRICULTURE
Mr. Brown. Thank you, Chairman Gillmor, for the opportunity
to appear today. My name is Rodney Brown and I am Deputy Under
Secretary for Research, Education and Economics in the
Department of Agriculture. I am pleased to discuss the role of
USDA in implementing the Food Quality Protection Act of 1996.
We are approaching the sixth anniversary of FQPA on August 3,
which is also the statutory deadline requiring reassessment of
two-thirds of all food tolerances that were in effect at the
time the law was enacted. Throughout these first nearly 6 years
of implementation, USDA has worked closely with the
Environmental Protection Agency to ensure a sound scientific
basis for regulatory decisions. Sound science must be based on
high quality data and providing such data to EPA has been one
of USDA's principal roles.
We have also worked in partnership with EPA, to ensure that
our agricultural producers and crop production experts in the
land-grant universities are active participants in supporting
the regulatory process. Through these efforts, we have helped
refine EPA's risk assessments and, when required, helped craft
regulatory strategies that make sense to farmers, reduce the
estimated risk and preserve many important uses of pesticide
chemicals.
Although FQPA placed a number of demands on USDA, the
challenges presented to EPA are even more demanding. EPA has
successfully pushed the frontiers of risk assessment science
and done an impressive job of dealing with the concepts of
aggregate and cumulative risk. Along the way, EPA had to
establish new science policies to guide state-of-the-art risk
assessment methods. We appreciate EPA's efforts as well as the
open and transparent processes they have used in
decisionmaking. We look forward to a continuing partnership
with EPA in implementation of the FQPA.
The Office of Pest Management Policy was created in
September 1997 to help the Department respond to the demands of
FQPA. OPMP has Department-wide responsibility and works across
all USDA agencies. OPMP relies on Agricultural Research Service
and Cooperative State Research, Education and Extension Service
scientists and crop production experts in the land-grant
university system for scientific and technical expertise.
The Department has provided high quality data to EPA in
support of pesticide risk assessments. The goal of both EPA and
USDA is to base regulatory decisions on the most accurate and
robust risk assessments possible. Working with EPA, we have
responded to the increased and changing needs for information
by collecting and summarizing key pieces of real-world data.
My written testimony addresses in further detail a number
of actions the Department has taken in response to the FQPA and
to address the needs of agricultural producers, EPA and other
stakeholders.
Thank you.
[The prepared statement of Hon. Rodney J. Brown follows:]
PREPARED STATEMENT OF RODNEY J. BROWN, DEPUTY UNDERSECRETARY FOR
RESEARCH, EDUCATION AND ECONOMICS, U.S. DEPARTMENT OF AGRICULTURE
THE OFFICE OF PEST MANAGEMENT POLICY
The Office of Pest Management Policy (OPMP) was created in
September of 1997 to help the Department respond to the demands of
FQPA. OPMP has Department-wide responsibility and works across all USDA
Agencies. The primary roles of OPMP are to coordinate and integrate
USDA pest management-related programs and policies and to provide a
central point of contact for EPA, growers, and other stakeholders. OPMP
allows the Department to more quickly and efficiently respond to issues
and needs arising from FQPA implementation. OPMP relies on Agricultural
Research Service (ARS) and Cooperative State Research, Education, and
Extension Service (CSREES) scientists and crop production experts in
the land-grant university system for scientific and technical
expertise.
DATA
The Department has provided high quality data to EPA in support of
pesticide risk assessments. The goal of both EPA and USDA is to base
regulatory decisions on the most accurate and robust risk assessments
possible. Working with EPA, we have responded to the increased and
changing needs for information by collecting and summarizing key pieces
of real-world data.
A critical piece of information in the assessment of human dietary
risk is food consumption patterns and quantities. The Continuing Survey
of Food Intake by Individuals (CSFII) conducted routinely by ARS to
inform the Department's nutrition programs also provides EPA with
statistically valid data for various age groups at the national level.
Because the FQPA places special emphasis on ensuring adequate
protection for children, USDA collected dietary consumption data on an
additional 5,000 children. EPA used these data to substantially improve
the confidence in children's dietary risk assessments. Working with
EPA, USDA scientists also developed ``recipes'' that translate the
food, as consumed and reported in the survey, into the basic
agricultural commodities that make up the food. For example, the survey
may report that a cheese pizza was consumed. The recipe translates the
pizza into quantities of wheat flour, oil, tomatoes, onions, water, and
milk as well as any other appropriate ingredients. The recipes mark the
first time that such a detailed breakdown of foods is available to the
public.
In determining the dietary exposure to pesticides, the other key
piece of information needed is the amount of pesticide residue in or on
food. When the daily consumption data are combined with the residue
data, daily dietary exposures can be calculated. The Agricultural
Marketing Service (AMS) began collecting pesticide residue data on
fresh fruits and vegetables a decade ago and has successfully expanded
the sampling program to include canned and frozen foods, grains, milk,
meat, poultry, and, most recently, drinking water. The program is
called the Pesticide Data Program (PDP) and for most commodities,
samples are taken as close to the consumer as possible while still
preserving the ability to identify the source. Both imported and
domestic foods are tested using extremely sensitive analytical methods.
PDP data are not available for all food-pesticide combinations. Where
PDP data are not yet available, EPA must rely on estimates of exposure
that frequently far exceed those measured at the consumer level. Use of
PDP data provides a realistic estimate of consumer exposure to
pesticide residues and results in a high level of confidence in the
accuracy of EPA's dietary exposure assessment.
The National Agricultural Statistics Service (NASS) collects data
on the pesticides used on a variety of crops. Data are collected
directly from a sample of farmers and include information on the
frequency, rate, and amount of pesticides used. The surveys are
designed to collect statistically valid data at the state level. NASS
data are used in the risk assessment process and also provide valuable
information concerning the relative benefits or importance of a
particular pesticide in crop production.
The Department (USDA) is working with EPA, the Geological Survey
(USGS), and pesticide manufacturers to develop better tools for
estimating the potential for pesticides to contaminate surface waters.
This is being done to assess levels that may be found in drinking
water--a requirement in estimating the aggregate risk a pesticide may
pose to humans under the FQPA. Pesticide use data are essential inputs
into the current efforts to develop a predictive regression model for
surface water contamination by pesticides.
USDA has also made basic agronomic and pest management data
available to EPA and all stakeholders. Working with our land-grant
partners, interested agricultural producers, and independent crop
consultants, the Cooperative State Research, Education, and Extension
Service (CSREES) and OPMP have funded and coordinated the development
and publication of nearly 500 ``crop profiles'' that detail basic
production and pest management information. The crop profiles are
available on the Internet and provide information that supports risk
assessment activities as well as the development of risk mitigation
strategies. Crop Profiles provide realistic patterns of pesticide use
rather than worst-case scenarios.
Building on the baseline information in the Crop Profiles,
commodity groups and land-grant university specialists are developing
Pest Management Strategic Plans to set priorities and guide research
and new product registration activities. Sometimes referred to as
Transition Strategies, these plans look to the future of pest
management needs for the commodity and production region. The plans
identify research, registration, education, and implementation
priorities required to change pest management strategies in response to
regulatory or consumer demands.
NEW RESEARCH PROGRAMS
Working with Congress, we developed and secured funding for three
new pest management research programs in FY-1999. These programs work
in concert with the already established Pest Management Alternatives
Program (PMAP) ($1.6 Million in FY-02) that focuses on short-term
alternative pest management tools.
The Crops at Risk program (CAR) ($1.5 Million in FY 02) provides
competitive research funding for pest management alternatives in crops
made vulnerable by FQPA implementation. The focus is on intermediate-
term solutions to major pest management problems.
The Risk Avoidance and Mitigation Program (RAMP) ($4.9 Million in
FY-02) focuses on long term competitive research funding for overall
crop and pest management systems.
The Organic Transition Program ($1.5 Million in FY-02) provides
funding for development of pest management strategies that help
interested growers move from traditional production practices to
organic agriculture.
INVOLVEMENT OF THE AGRICULTURAL COMMUNITY
Since passage of the FQPA, USDA has sought ways to inform and
involve the agricultural community in implementation. EPA has been
equally concerned about involvement of agricultural producers and has
worked with us to develop transparent processes that encourage
participation by all stakeholders.
One very successful mechanism has been the use of external advisory
committees. EPA originally chartered the Tolerance Reassessment
Advisory Committee (TRAC) in 1998 and subsequently rechartered it as
the Committee to Advise on Reassessment and Transition (CARAT). The
Deputy Secretary of USDA co-chairs the committee with the EPA Deputy
Administrator.
Working with EPA and the agricultural community, USDA ensures that
grower interests are represented in all pesticide regulatory decisions.
OPMP conducts meetings and conference calls on specific chemical re-
registration decisions. Using these mechanisms, agricultural producers
have the opportunity to address risk assessment issues, crop production
practices, and help develop workable risk reduction strategies.
Pest management experts associated with the land-grant universities
work through the four recently created Regional Pest Management Centers
in order to more efficiently and effectively address scientific
research, regulatory, and implementation issues. Pest management
experts have used the Regional Pest Management Center concept and
structure to improve the exchange of information, achieve greater
cooperation and improve stakeholder involvement.
REGISTRATION OF ALTERNATIVE PRODUCTS
USDA's Inter-Regional Project Number 4 (IR-4) program is supported
by both CSREES and ARS and remains the principal means by which
products are registered for minor uses. Generally, minor uses are
specific uses in small markets where registration costs exceed
potential returns to pesticide manufacturers. In these cases, the IR-4
program provides the expertise and much of the funding required to
conduct field trials and prepare registration packages. Without
adequate pest control measures, farmers would find it impossible to
produce economically viable crops of fruits and vegetables that are
absolutely critical to good nutrition and health. Loss of production
could also seriously impact local farm economies and food processing
interests. Pesticide manufacturers still bear the large costs of health
and environmental testing required for initial registration of new
active ingredients, but the IR-4 Program helps to ensure that many
fruit and vegetable crops have access to these new production tools.
Over the last several years, IR-4 registrations have accounted for the
majority of EPA's new crop registration decisions. EPA works closely
with the IR-4 program to build increased efficiency into the minor crop
registration program. Since passage of the FQPA, IR-4 has aggressively
pursued the registration of new and safer pest management technology.
While I believe that USDA has made significant progress and
contributed appreciably to the implementation of FQPA, I also recognize
that there are a number of issues that demand further attention.
Regulatory and research programs operate on very different time
lines and we need to find ways to improve our ability to keep pace with
rapidly changing research and data collection needs. The CAR and RAMP
programs mentioned earlier have been successful in responding to these
changing needs. The Pest Management Strategic Plans, also mentioned
earlier, are powerful tools that assist in anticipating research needs
and we are making greater use of these planning tools in establishing
the research agenda.
In some cases, implementation of alternative pest management
technologies and strategies has been slow. New technology frequently
demands education and training and often requires more information and
more management time. Agriculture is subject to an almost endless array
of variability in weather, pest, and economic cycles. Alternative
methods must be proven to work consistently outside of the confines of
closely monitored trials and small-scale demonstrations. Regulation and
consumer demand are driving agricultural producers to change production
technologies but we also need to look for ways to provide growers
greater incentive to adopt newer and safer pest management systems.
Demands for pesticide use and residue data are usually far greater
than our ability to supply them and we must carefully adjust
priorities. In both of these areas, USDA will continue to work closely
with EPA and USGS to better anticipate and plan for future data needs.
Some of the most promising pest management research involves
biotechnology, but the lack of consumer acceptance, especially in
export markets, has slowed the development and adoption of innovative
solutions to many pest problems. Building consumer confidence in our
research and all federal regulatory programs is essential to the
ultimate acceptance of biotechnology and our ability to bring a new
generation of pest management strategies on-line.
The Food Quality Protection Act of 1996 changed the standards for
pesticide safety and laid out a rigorous time line to complete the
review of all existing food tolerances. I am pleased with the working
relationship that we have established with the EPA and look forward to
a continued partnership as we work through the remainder of FQPA
implementation.
Mr. Gillmor. Thank you very much, Dr. Brown, and your full
statement will be a part of the record.
The representatives of the U.S. EPA have arrived and we
would invite them to come forward to the witness table.
Adam Sharp is the Deputy Associate Administrator in the
Office of Prevention Pesticides and Toxic Substances and he is
joined by Lois Rossi, who is the Director of Pesticide
Programs.
So we will turn it over to you for a brief statement.
STATEMENT OF HON. ADAM SHARP, DEPUTY ASSOCIATE ADMINISTRATOR,
OFFICE OF PREVENTION PESTICIDES AND TOXIC SUBSTANCES, U.S.
ENVIRONMENTAL PROTECTION AGENCY
Mr. Sharp. Thank you, Congressman. I appreciate the
invitation to be here today. It has been an interesting
morning, but we made it. We have been on the road for a few
hours, not expecting the snow. But I do appreciate the
invitation to come here to this field hearing on the Food
Quality Protection Act. I know it is the first official hearing
on this law since it was passed in 1996.
A little bit about myself first. I am brand new at the EPA,
just started not even 2 months ago, but it is nice that the
first FQPA hearing is in Ohio, because this is where I am from,
family farm in southeastern Ohio, raised on a dairy and
livestock farm about 3 hours southeast of here; graduate of
Ohio State University College of Agriculture and worked for the
Farm Bureau for the last 7 years in Washington, DC as their
pesticide specialist. So this issue is something that is very
near and dear to my heart and I understand the needs of a lot
of folks who will be testifying today on the topics we are
going to discuss.
I am also pleased to be here with USDA. They have been a
good partner as we have moved forward in FQPA implementation
and then also I wanted to introduce Lois Rossi, Division
Director for Special Review and New Registration at EPA. I am
going to be relying on her for some expertise, being that I am
still coming up to speed on some of the issues that we are
dealing with. I welcome the opportunity to discuss this law and
bring you up to date on the Agency's activities in implementing
this important piece of legislation.
Let me first start of with what is FQPA. FQPA was developed
based on a desire to establish a single food safety standard
for both raw and processed food commodities. The new law
reflected the desire of Congress to increase to protections
regarding potential dietary risks from pesticides and to move
the Federal food safety system ahead scientifically.
The new health based safety standard embodied in FQPA calls
for a reasonable certainty of no harm standard. FQPA mandated
that the Agency, as appropriate, utilize an extra tenfold
margin of safety for special sensitive populations. The
legislation also introduced new rigorous, scientific criteria,
such as aggregate exposure, and new requirements to evaluate
cumulative risk for exposure to multiple pesticides which share
a common mechanism of toxicity, or cumulative risk assessment.
I will talk more about that in a second.
Since enactment of FQPA, EPA has worked to implement the
new requirements in a way that achieves the goals of reducing
pesticide risks. We also need to recognize that it is essential
that farmers continue to have the tools that they need to
provide the American public with the safest, most abundant food
supply. The Agency also followed several important principles
in implementing the Food Quality Protection Act; namely,
ensuring that we use sound science, that our actions are
transparent and I think we have done an admirable job of that.
We have extensively consulted with the public stakeholders and
other Federal agencies, particularly with the U.S. Department
of Agriculture, USDA, here to my right, and that our decisions
also allow a reasonable transition for agriculture to adopt new
pest management tools and techniques.
Some of the key accomplishments under FQPA. EPA has had
many successes implementing the law. We have met deadlines
established for the reassessment of pesticide tolerances, taken
significant action to reduce risks when necessary and done so
in a responsible manner. We have established greater
communication with groups, stakeholders and others impacted by
our decisions and improved our coordination with the U.S.
Department of Agriculture on pesticide issues.
To that end, EPA and USDA have established the Committee to
Advise on Reassessment and Transition, known as the CARAT
Committee--sometimes a tongue twister--to strengthen the
interaction with all stakeholders involved. The CARAT helps to
ensure that our decisions are open, well understood and take
into consideration the input from all stakeholder groups.
Some of the important milestones for FQPA implementation.
Under the Food Quality Protection Act, EPA is required to
reassess some 9700 existing tolerances to ensure that they meet
new safety standards that were created under the FQPA. The
Agency met the first statutory deadline that we had and we plan
to meet the next one as well, this coming August. EPA, under
the previous administration, also settled a lawsuit with the
Natural Resources Defense Council, which also established some
deadlines for reassessment. We have met the deadlines under
that settlement as well and plan to continue to meet the
deadlines established under that settlement. Sound science and
the importance of protecting public health will continue to
drive our decisions.
Cumulative risk. As I mentioned earlier, FQPA requires
several advances in the science supporting the regulation of
pesticides. Perhaps no area is more complex than assessing
cumulative, risk, in which the Agency must consider the effects
of multiple pesticides that act the same way in the human body.
Recently, these methods have been used to conduct a
preliminary cumulative risk assessment for organophosphate
pesticides which have been identified--this first class of OPs,
as they are commonly referred to, will be the first cumulative
risk assessment done and there was a common mode of action
established for that group of pesticides. This preliminary
assessment has recently been reviewed by independent scientists
and released for public comment. We expect to incorporate the
scientific recommendations, as appropriate, and publish an
updated cumulative risk assessment for the organophosphates
this coming spring. This cumulative assessment is expected to
be completed by August of this year.
Identifying potential non-contributors. This is an issue
that got some discussion in the last CARAT advisory committee
just a couple of weeks ago. Currently, EPA is exploring the
concept of whether there are tolerances that could be
reassessed prior to August because they are not know to make
any negligible contribution to cumulative risk. The Agency is
currently developing a Federal Register notice expected to be
published this spring--actually in the next week or 2--that
discusses the general criteria in identifying non-contributors
for chemical/crop combinations.
Some of the principles for FQPA implementation that we have
evolved. Through all these activities, we have worked hard to
open up our processes for making decisions and have allowed for
public comment on preliminary decisions so that they may have--
so that those who may be affected by those decisions have the
opportunity to share relevant information and real experiences.
We have sought input from the public and the agencies, such as
the Department of Health and Human Services and USDA, to bring
differing perspectives and expertise to bear on our decisions.
EPA is also working hard with USDA to address the challenges of
transition. It is important that EPA and USDA focus our efforts
on developing a seamless and coordinated approach to ensuring
growers and others have the necessary pesticide tools in the
future.
Conclusion--a couple of high points--it is our pleasure to
be here again today with USDA. Decisions on pesticides must be
made within a full partnership between the Department and the
Agency. We recognize the very real impacts that our decisions
can have on people who make their living through agriculture
and USDA and others,a nd we understand that USDA plays a vital
role in coordinating our efforts with farmers and pesticide
users. I look forward to strengthening that effort within the
Agency.
EPA recognizes that it is important for us to have a full
and open dialog with all stakeholders. The Agency is listening
carefully to the concerns of everyone as we proceed with FQPA.
We have held numerous stakeholder meetings and numerous
conference calls and advisory group meetings to seek that
input. There has been an overwhelming response I think by
commodity groups and non-agricultural pesticide user groups to
partake in a number of those types of sessions and meetings and
conference calls. The Agency is listening to those comments. It
is with these commitments, with everyone at the table,
listening and learning, that we will successfully address the
current and future challenges in implementing this very
important law.
Thank you for the opportunity to comment here today. I
appreciate and look forward to answering any questions you may
have.
[The prepared statement of Hon. Adam Sharp follows:]
PREPARED STATEMENT OF ADAM SHARP, ASSOCIATE ASSISTANT ADMINISTRATOR,
OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES, U.S.
ENVIRONMENTAL PROTECTION AGENCY
INTRODUCTION
Thank you for the invitation to appear before you today. My name is
Adam Sharp and I am the Associate Assistant Administrator for the
Office of Prevention, Pesticides, and Toxic Substances at the
Environmental Protection Agency (EPA). While I have only been with the
Agency for two months, I have worked on pesticide issues for some time.
Certainly the most profound change in pesticide regulation has been the
1996 passage of the Food Quality Protection Act (FQPA). I welcome the
opportunity to discuss this law and bring you up-to-date on the
Agency's activities in implementing this important piece of
legislation.
WHAT IS FQPA?
FQPA was developed based on a desire to establish a single food
safety standard for both raw and processed food commodities, while also
taking coverage of pesticide residues out of the scope of the so-called
Delaney Clause. The new law reflected the desire of Congress to
increase the protections, particularly for children, regarding
potential dietary risks from pesticides, and to move the federal food
safety system ahead scientifically.
The new health based safety standard embodied in FQPA calls for a
reasonable certainty of no harm to human health. FQPA mandated that the
Agency, as appropriate, utilize an extra ten-fold margin of safety for
children. The legislation also introduced new rigorous, scientific
criteria--such as aggregate exposure--to evaluate all possible routes
of pesticide exposure together and new requirements to evaluate
cumulative risk from exposure to multiple pesticides which share a
common mechanism of toxicity.
When FQPA was passed, EPA had only limited experience with these
new and groundbreaking scientific and regulatory requirements. FQPA
significantly strengthened the safety standard for all pesticides used
on food, and identified a set of complex scientific issues, which have
taken years to address.
Since enactment of FQPA, EPA has worked to implement the new
requirements in a way that achieves the goals of reducing pesticide
risks, particularly for children, while recognizing that it is
essential that farmers continue to have the tools they need to provide
the American public with a safe and abundant food supply. The Agency
has followed several important principles in implementing FQPA, namely
ensuring that we use sound science, that our actions are transparent,
that we extensively consult with the public and other federal agencies,
particularly with the U.S. Department of Agriculture (USDA), and that
our decisions allow a reasonable transition for agriculture and for the
important public health uses of pesticides, to adopt new pest
management tools and techniques.
KEY FQPA ACCOMPLISHMENTS
EPA has had many successes in implementing FQPA. We have met
deadlines established for the reassessment of pesticide tolerances
(legal residue limits), taken significant actions to reduce pesticide
risks in a reasoned and responsible manner, established greater
communication with groups impacted by our decisions, and improved our
coordination with the USDA on pesticide issues. To that end, EPA and
USDA have established the Committee to Advise on Reassessment and
Transition (CARAT) to strengthen the interaction with all our
stakeholders. CARAT helps to ensure that our decisions are open, well
understood, and take into consideration the input from all interested
parties. In addition, EPA Administrator Christine Todd Whitman created
a position on her immediate staff for a Senior Agricultural Advisor and
appointed Jean Marie Peltier, who previously worked closely with
California agriculture and was an experienced state regulator.
Despite the additional requirements imposed by FQPA, EPA has been
able to maintain its pre-FQPA productivity in registering new
pesticides and reduce the response time for emergency exemption
requests. Working with USDA, we have significantly improved the data
used to make decisions on the registration and reregistration of
pesticides. We have also taken steps to make our reviews, and the
science supporting them, more transparent for growers and the public.
While it has been five and a half years since FQPA took effect, we have
seen an increase in the registration of reduced-risk pesticides and
risk mitigation for some existing pesticides.
IMPORTANT MILESTONES IN FQPA IMPLEMENTATION
Under FQPA, EPA is required to reassess some 9,700 existing
tolerances to ensure that they meet the new safety standard. The Agency
was given statutory deadlines for accomplishing these reassessments,
the first of which was to reassess 33 percent of the existing
tolerances by August 3, 1999. We met that goal, and anticipate meeting
the next statutory goal, which is to reassess an additional 3,208
tolerances, or 33 percent, by August 3 of this year. EPA also settled a
lawsuit by the Natural Resources Defense Council (NRDC), concerning the
progress of reassessment and the priority we were giving to evaluating
certain pesticides. We have met all the deadlines required by that
settlement to date, and we fully expect to continue to meet the future
deadlines. Throughout tolerance reassessment and compliance with the
NRDC deadlines, it is important to note that our decisions will
continue to be fully supported by sound science and extensive
stakeholder involvement. Sound science and the importance of protecting
public health will continue to drive our decisions.
CUMULATIVE RISK
As I mentioned earlier, FQPA requires several advances in the
science supporting the regulation of pesticides. Perhaps no area is
more complex than assessing cumulative risk, in which the Agency must
consider concurrently the effects of multiple pesticides that act the
same way in the human body. The concept of cumulative risk has been
discussed by scientists for years, but FQPA required the Agency to
actually apply it on an ongoing basis for specific pesticides which
share a common mechanism of toxicity. After years of scientific work,
the Agency has now developed a preliminary framework for conducting
cumulative risk assessments. These new tools and methods were developed
in consultation with independent scientific groups.
Recently, these methods have been used to conduct a preliminary
cumulative risk assessment for organo-phosphate insecticides, which
have been identified as one of the pesticide classes which share a
common mode of toxicity. This preliminary assessment has recently been
reviewed by independent scientists and released for public comment. We
expect to incorporate the scientific recommendations, as appropriate,
and publish an updated cumulative risk assessment for the
organophosphates this Spring. This cumulative assessment is expected to
be completed by the August 3 deadline.
IDENTIFYING POTENTIAL NON-CONTRIBUTORS
Currently, EPA is exploring the concept of whether there are
tolerances that could be reassessed prior to August because they are
known to make, at most, no more than a negligible contribution to
cumulative risk. The Agency is currently developing a Federal Register
notice that discusses the general criteria used in identifying non-
contributors for chemical/crop combinations. We expect this notice to
be published this Spring for public comment.
FQPA IMPLEMENTATION PRINCIPLES
Through all of these activities, we have kept our implementation
principles firmly in mind. We have applied the most stringent and
exacting scientific standards to ensure that we take only those actions
that are necessary and effective. We have worked hard to open up our
processes for making decisions, and have allowed for public comment on
preliminary decisions, so that those who may be affected have the
opportunity to share relevant information and real experiences. We have
sought input from the public and agencies, such as the Department of
Health and Human Services and USDA, to bring differing perspectives and
expertise to bear on our decisions. EPA is also working hard with USDA
to address the challenges of transition. It is important that EPA and
USDA focus our efforts to develop a seamless and coordinated approach
to ensure growers have the necessary pest control tools. I would also
like to acknowledge the roles that states have played in reaching the
agricultural community and in carrying out the decisions under FQPA.
CONCLUSION
It is a pleasure to be here today with USDA. Decisions on
pesticides must be made within a full partnership between USDA and EPA.
We recognize the very real impacts that our decisions can have on
people who make their living through agriculture and USDA has played a
vital role in coordinating our efforts with farmers and other pesticide
users. Our decisions must fully protect public health and the
environment, while being sensitive to the needs of agriculture.
EPA recognizes that it is important for us to have a full and open
dialogue with all stakeholders. The Agency is listening carefully to
the concerns of everyone as we proceed with FQPA. It is with these
commitments, with everyone at the table, listening and learning, that
we will successfully address the current and future challenges in
implementing this important law.
Thank you for the opportunity to appear before you today. I will be
pleased to answer any questions that you may have.
Mr. Gillmor. Thank you, Mr. Sharp. Did you have an
additional statement, Ms. Rossi?
Ms. Rossi. No, sir.
Mr. Gillmor. Okay.
If I might start by asking you some questions, Dr. Brown.
Could you explain more fully the differing roles that EPA and
USDA play in reassessing pesticides and could you describe how
you think that relationship is working?
Mr. Brown. Certainly. First of all, as I mentioned before,
EPA has the major direct responsibility and I believe the major
challenge in this process.
On the other hand, USDA, first of all feels a great
responsibility to provide correct scientific data to EPA for
their purposes, at their request. Also, as we see areas that we
within USDA feel need more data, better data, different kinds
of data and so on, we are working to provide that information.
Second, as the risk assessments are prepared, USDA works
with the producers to review those risk assessments. There is a
challenge there that we face constantly in that these risk
assessments come after much work and much preparation and
usually with a rather short time line for review.
Finally, in the implementation area, the USDA is involved
with the producers, through the land-grant universities and
others who work with producers directly to implement these new
programs.
Mr. Gillmor. Is USDA, in your view, a full partner with EPA
in reviewing and approving the tolerance reassessments?
Mr. Brown. I believe that USDA is without a doubt a full
partner with EPA in this process.
Mr. Gillmor. What is the size of USDA's staff that is
dedicated to Food Quality Protection Act process and in your
view are more staff and resources needed to allow the
Department to interact more fully with EPA as it plows ahead to
meet the statutory guidelines, and also the deadline set by the
NRDC lawsuit?
Mr. Brown. We have 12 people assigned to the office
directly. But, I should point out here that budget-wise, which
is the easiest way for me right now to report USDA's
contribution, in 2001, USDA devoted $88 million to Food Quality
Protection Act related activities. There was $92.5 million in
2002 and again in the 2003 budget.
We clearly would like to have more resources, especially in
the area of risk assessment. We are doing our best to keep up
with the data requirements as they come through.
Mr. Gillmor. Do you think that the NRDC lawsuit and the
tighter timeframes that have been imposed on EPA have hindered
USDA's ability to be involved in the Food Quality Protection
Act tolerance review process?
Mr. Brown. Shorter time certainly makes it harder to keep
up. The challenge here is that we are dealing with practices
used in agriculture that have developed over 100 years, however
many years you want to go back, and we are trying to find new
ways, replacements and so on in a very, very short time. When
that time is shortened even further, of course, it makes it
much more difficult to keep up.
Mr. Gillmor. Let me go to Mr. Sharp and Ms. Rossi, either
one of you may feel free to answer.
Conducting improved risk assessments of the high priority
pesticides is at the heart of the FQPA process, and although
many of EPA's reassessment decisions have been accomplished by
clearing away the underbrush approach in the form of voluntary
cancellations of outdated tolerances, under FQPA, EPA is
conducting some of the most complex and laborious risk
assessments it has ever undertaken and those assessments
combine theoretical modeling with available data to estimate
the likely health and safety risks presented by those
chemicals. So the question is what is the state of the science
for these aggregate and cumulative exposure modeling
procedures?
Mr. Sharp. There has been extensive science policy
development on behalf of the Agency. Over 20 different science
policy areas have been identified within work groups such as
the CARAT work group, starting 6 years ago--actually starting
pretty much when the law passed.
So initially there was a lot of identifying of where the
science needed to be developed and what needed to be flushed
out, what kind of data was needed. And this began 6 years ago.
In the meantime, there has been over 20 of these different
science policies that have been identified, all of them have
been put out for public comment by the Agency and there has
been 23 different science advisory panel meetings held. And the
science advisory panel of course is an independent body of
scientists that review the work of the Agency and we have taken
various pieces of the FQPA science policies to that panel 23
times--6 times just for the cumulative risk assessment
directly. For aggregate, I believe at least once or twice, as
well as also public comments on those policies as a whole and/
or in part as well.
The cumulative policy, the last portion of it had gone to
the science advisory panel just not long ago actually. It was--
the preliminary cumulative risk assessment was sent to the SAP
to review about a month ago and they actually just gave us back
their science advisory panel report on the cumulative
assessment not even a week ago. So we are right now reviewing
the assessment on it.
So there has been a thorough vetting of the science
policies involved in FQPA, because as you said, they are
incredibly complex and incredibly confusing. But there has been
a tremendous amount of input given by industry, environmental
groups, agriculture and others as well, into that process.
Mr. Gillmor. As I understand it, assessing risk is a
function of assessing toxicity and exposure; and that is, risk
is not just measured by how toxic a substance may be, but it is
also necessary to assess the potential for exposure to that
substance in order to determine whether it presents a risk.
Now with regard to FQPA, you believe that the exposure of
children to organophosphates in the form of residues on fruits
and vegetables is properly being estimated by EPA and is there
any reason to think that exposure of children is being either
substantially under- or over-estimated under the FQPA process?
Mr. Sharp. I think it is being pretty adequately assessed
when you are looking at exposures. There are various portions
of data that are used to look at the exposure of various groups
of populations, age groups primarily, and the Agency actually
looks at data by different age groups, children being one of
those age groups that is considered when looking at risk and
looking at exposure.
So, no, I think actually as far as the law being
implemented, as far as the actions being taken, the assessments
that are being conducted are fair, they are not under- or
necessarily overly assumed.
Mr. Gillmor. Thank you. Dr. Brown, do you agree basically
with Mr. Sharp's assessment?
Mr. Brown. Yes, in principle I do. We have a couple of
concerns. One is again with the need to deliver data quickly
and the quantity and quality of data that needs to be provided.
One instance in particular is in the data on consumption
provided by the Agricultural Research Service. When that data
was collected, it included a warning against use of this data
for statistical purposes. We would feel more comfortable if we
had more complete and better data, and I am sure EPA would
agree.
Mr. Gillmor. And Mr. Sharp is indicating he agrees with
that.
Dr. Brown, a risk assessment is only as good as its data
and FQPA requires EPA to consider more data for tolerance
reassessment than it ever has in the past. And as a result,
EPA's risk assessment employs data sets of varying scope,
varying quality, and while some of the data are provided by
manufacturers, other data are provide by Federal agencies,
including USDA. Can you describe the types of dietary exposure
data USDA is contributing to the Food Quality Protection Act
implementation, and in your view--well, let us just leave it at
that.
Mr. Brown. Yes, the primary data with regard to consumption
is a continuing survey of food intake by individuals. This is
conducted routinely by the Agricultural Research Service
nutrition programs, which provides data to EPA linked to
various age groups. This is especially important as we look at
the needs of infants and children.
Because the FQPA has special emphasis in these areas, we
added 5,000 children to the data survey last time it was done,
to improve the quality of the data there. Determining dietary
exposure to pesticides is very difficult without increasingly
large surveys to improve the data. We have improved--we are
closer, we do not think we are as close as we would like to be.
Mr. Gillmor. Thank you very much.
Mr. Sharp, as I understand it, EPA's computer model for
cumulative exposure does not allow for identification of risk
drivers, meaning uses that are significantly contributing to
exposure resulting in unacceptable levels of cumulative risk.
Has EPA identified any risk drivers so far in its draft
cumulative risk assessment of organophosphates? And if not,
when will the Agency be able to do so?
Mr. Sharp. Actually the model, you can find drivers, but it
is a highly process and maybe more time consuming than need be.
But there are a couple of other models being developed, one by
industry and then another one that is being developed by a
private group. The idea right now is that the model I believe
that is being developed by industry is going to be sent to a
science advisory panel to review as well here in about a month.
And they are going to look at the accuracy and the model
development there.
And then what we are going to do is we are going to look at
comparing the model that the Agency has compared to these other
couple of models and basically do some truth testing and see
what each one of these models are saying and what they are
predicting, and at that time, we will be able to determine if
there are certain areas that are showing more of a driver for
risk than others. Right now we have not done that yet. So
directly to that part of your question, we do not--have not yet
and have not run a run to find out what those risk drivers may
be to date. But we will certainly be doing that and we will be
doing that this spring actually.
The idea is that we have until--we have until the end of
May, is what we have set ourselves as our own deadline on
recommendations from the public to release a preliminary or a
refined risk assessment of the cumulative group of OPs. So that
is our goal right now, is to put out a revised version of that
by the end of May or the first week in June and we committed
that publicly a couple of weeks ago. And at that time, this
question will be further down the road and we will be able to
answer it better and talk more about the drivers as well as the
other models in some of the comparing that we are going to do
before we release a final product.
Mr. Gillmor. Thank you very much.
Mr. Sharp. Thank you.
Mr. Gillmor. Dr. Brown, Food Quality Protection Act
implementation has a substantial economic impact on the
agricultural sector, and ultimately, based on the risk
assessment and other statutory factors, EPA must decide whether
to revise or revoke existing tolerances and exemptions, require
changes in how pesticides are labeled and otherwise restrict or
reduce the use of certain pesticides on food.
Those pesticide manufacturers and users must anticipate
those changes and begin to evaluate their options including the
development of substitute products. Can you describe the range
of mitigation steps that you expect farmers to be faced with
once the cumulative exposure assessment of OPs is completed?
Mr. Brown. I would like to comment on that. First of all,
there are a range of challenges to producers, depending on what
they are producing. One of the biggest challenges is in the
crops that are sometimes referred to as minor crops. If you
look at the cash value of the crops produced in the United
States, the minor crops are right around half, so I think minor
may not be the right word. But there are pesticides and
treatments used on these crops which are used in small enough
quantities that it is not economically feasible for the
producers to go through the recertification process. In that
case, a program called IR-4 has been used. This is a joint
program with USDA and EPA and the producers and so on, which is
being used to help with some of these low volume products. The
IR-4 program has been able to in fact, on a numbers basis,
account for the majority thus far of the reregistrations.
If we have time to prepare, we can have strategic plans for
various crop uses and ways to help through the county agents
and the commercial crop specialists and all the other people
involved to help producers switch over. We cannot always switch
over and meet the new requirements at the same cost, which is a
great concern, as we are more and more involved in world trade
and we are more and more concerned about regulations that
affect American producers differently than they affect
international producers.
Mr. Gillmor. Let me direct a question both to you, Dr.
Brown, and also to you, Mr. Sharp. In your view, are the issues
relating to FQPA, which are raised by land-grant universities
and grower groups that your Department interacts with routinely
being adequately heard in Washington and being properly
addressed in the Food Quality Protection Act process, and is
the assessment process, review process, CARAT process, working
effectively in your view? And what additional improvements
would you identify and recommend?
Mr. Brown. I believe beyond the day-to-day work of
collecting data and going through all the work that EPA has to
do in each case, the input from the growers, from the land-
grant universities and so on, is essential to make sure we do
the right things; and I should add that we do the most
important things first.
We have established four regional pest management centers
which are serving a great need in this area to help us go ahead
with this work.
Mr. Sharp. Starting off with the CARAT, the CARAT is, of
course, a transition advisory group from the TRAC and the TRAC
that was established right after FQPA was passed and it has
about 40-50 members on it from all different stakeholder
groups, including USDA/EPA representation as well as CDC and
some other folks who have sat on it at various times. And also
at those meetings--and I think I have been to every single one
of them and there have been a number of them that have been
very productive--really a lot of the concerns that I think
initially were being heard on FQPA were addressed within CARAT
to a degree of process, and there was a lot of questions about
what is the process that EPA does to assess risks of
pesticides.
As those questions became clear, this advisory group helped
advise the Agency and the Department on how to come up with a
process that everybody understood and everybody had an ability
to have input into. And through that process, we developed the
six-step FQPA risk assessment process. It is very clear,
products move from step one to step six and there is input at
various times to the public. So that has been, I think, one of
the major achievements of CARAT. So that is one part of this.
The identification of science policy, as I mentioned
earlier, has been another very key part of the CARAT that has
helped the Agency and the Department focus on how to do this
risk assessment under the Food Quality Protection Act.
So there has been several things that the CARAT has been
instrumental on, incredibly key things. And that has come from
the input of all the stakeholder groups. So the CARAT has been
successful. We plan on continuing the CARAT and we are actually
going to have another work group meeting of the CARAT here in a
couple of months when we have released this draft of the
cumulative risk assessment. So that in partial has brought in
some of the grower groups' and stakeholders' concerns.
I also mentioned that as we move through the six step
process, EPA has more than several staff who help us identify,
in working with USDA, identify users and those who are the
folks who are on the ground using these products, and those who
understand how they are used and are bringing them into the
process. So we have a formal comment period on individual risk
assessments, which was also something that I think came out of
input from the CARAT and the TRAC, that allows people to
formally file comments into the process on individual risk
assessment and also give or provide information to the Agency.
In addition to that, we then hold follow up conference calls
for individual products and then we hold a final closure call
on individual products before a risk assessment decision is
made, so we have a lot of opportunities to have the
stakeholders involved, particularly farmers and growers and
folks who know how to use the products. So those have been
incredibly helpful. I think since the FQPA has been passed in
1996 until now, you have seen an incredible increase in the
quality of the risk assessments that are being produced because
of that input.
Mr. Gillmor. Well, thank you very much. We will wrap up
this first panel, but your full statements are part of the
record and anything else that you want to submit.
Also before we break with this panel, I would ask if there
is any brief comment that you care to make in summary. If you
do, feel free.
Mr. Brown. From USDA's point of view, again, we appreciate
the working relationship which has developed and continues to
develop with EPA. We have some concern that, first of all, as
this process started, many of the fears that we and others had
have been resolved by continually working together, but we do
have a concern that science to do the job is being developed
along with the policies. There is some concern now, I know EPA
has the same concerns, and there are crops out there, many of
them we continue to hear about, that we are worried about the
impact on things such as apples, peaches, grapes, tomatoes,
especially in the area of cumulative risk. We are going to have
to figure out how to deal with that.
Another one that has come up that is a great concern is a
chemical used in the storage of small grains, especially in
smaller storage areas where we seem to have no alternative and
we have a long way yet to work through that.
We appreciate the time to be here.
Mr. Sharp. Thank you. I have worked with USDA on FQPA
issues for years and it is a tough law to deal with as far as
scientific standards and developing this process. The Agency
and the Department have come a long way and I think we still
have a long way to go though. There are a number of challenges
that we do face in developing science policies, we are getting
there and with the help of the science advisory panel,
stakeholders and others, the information is ever increasingly
good.
I am looking forward to strengthening our ties with USDA in
this process because I really do think that the information
that they provide, especially PDP data, is terrific stuff that
is used. It gives a good accurate portrayal of what really is
happening out there as far as exposure to the public.
Cumulative risk assessment--and Dr. Brown touched on
cumulative risk assessment--a little bit about kind of where we
are, to wrap up on things. We had 9700 tolerances that EPA is
to reassess over a 10-year timeframe. We have finished about
4,000 of those. The goal or the next statutory deadline that is
required by Congress is 6,400 products to be finished by this
coming August. We hope to actually get beyond that and have
more like about 7,000 completed by August. So we think we are
well on our way to meeting the statutory goals.
Also, as fare as the NRDC settlement, they are releasing a
revised cumulative risk assessment. We do plan to meet that
goal as well and to have that revised policy released before
August, possibly as early, as I mentioned, by early May. So we
may meet that deadline actually early.
Strengthening our ties in some of the other areas with HHS
and other groups, CDC, who are also involved is something else
that we need to work on more. USDA has been a great partner at
the table in CARAT and others, and we look forward to
strengthening the ties with some of these other branches of
government, who have had key input on certain areas and on
certain products, but we would like to do more.
So there are certainly some challenges left and we look
forward to working on those with the Department and others.
So thank you for having us out today, I appreciate it.
Mr. Gillmor. Well, thank you both for your input.
We will take about a 1-minute break so that the second
panel can come forward.
[Brief recess.]
Mr. Gillmor. In addition to the witnesses we will be
hearing from this morning, we have had a number of groups who
have asked to submit testimony--Improving Kids' Environment
from Indianapolis, the Implementation Working Group, CropLife
America and The American Nursery and Landscaping Association.
And without objection, these will be included in the committee
record and the subcommittee will also keep the record open for
a 10-day period to receive additional statements.
Our panel this morning is Mr. Terry McClure, who is
President of the Ohio Farm Bureau Federation; Christiane
Schmenk, who is the Director of the Environmental Stewardship
Team of The Scotts Company representing CropLife America;
Robert Marquette, who is President of Ram Exterminating on
behalf of the Ohio Pest Control Association; and Mr. Jeffrey
Zellers, a farmer, who is President of K.W. Zellers & Son of
Hartville, Ohio. And one witness who was scheduled to be here,
Jane Forrest Redfern, representing Ohio Citizen Action, called
this morning, she is from Dayton, and said she would not be
here because of the weather.
Always deferring to presidents, we will go to Mr. McClure
first.
STATEMENTS OF TERRY McCLURE, PRESIDENT, OHIO FARM BUREAU
FEDERATION; CHRISTIANE W. SCHMENK, DIRECTOR, ENVIRONMENTAL
STEWARDSHIP TEAM, THE SCOTTS COMPANY; ROBERT MARQUETTE,
PRESIDENT, RAM EXTERMINATING ON BEHALF OF THE OHIO PEST CONTROL
ASSOCIATION; AND JEFFREY ZELLERS, PRESIDENT, K.W. ZELLERS & SON
Mr. McClure. Thank you, Mr. Chairman, and thank you for
bringing this hearing here to our District, we appreciate that.
My name is Terry McClure, I am a partner with my family in
McClure Farms in Grover Hill, Ohio, located in Paulding County.
I also currently serve as the President of the Ohio Farm Bureau
Federation, the state's largest farm organization. Our family
raises corn, soybeans and wheat on 2700 acres. As a responsible
user of crop production products, I depend upon those tools to
control week and pest problems and provide the world and U.S.
consumer with a safe, nutritious, affordable food supply.
I thank Chairman Gillmor and the subcommittee for the
opportunity to share my concerns regarding the implementation
of the Food Quality Protection Act of 1996. I also have the
privilege of sharing with you a letter containing perspective
of 13 county Farm Bureau presidents in Representative Gillmor's
district and ask to have it included in the record.
Mr. Gillmor. I had the opportunity to meet with the Farm
Bureau presidents about a week ago, so we are happy to hear
from them.
Mr. McClure. Thank you.
A $73 billion component of the state's economy, agriculture
is important to Ohio's continued viability. Here in
Representative Gillmor's district, agriculture accounts for
$6.6 billion in economic output and employs nearly 81,000
Ohioans. Although we have a unique agriculture in Ohio with
livestock, grains and oilseeds product alongside a wide variety
of fruits and vegetables, virtually all of Ohio agriculture is,
in some form or another, dependent on crop protection products
for its success, and will be affected by the decisions EPA
makes in determining the process by which these important tools
will be reviewed.
As FQPA implementation moves forward, our concern lies in
the fact that OPs are just the first pesticide class to be
subject to review and reassessment. As other pesticide classes
are reviewed, the reassessment will be approached in much the
same manner and adhere to the same policies currently under
development. This is not a concern about a few minor uses of
pesticides, but rather the use of one of U.S. agriculture's
main production tools is at issue.
How FQPA affects farming operations--the agricultural
industry in Ohio and the United States is experiencing intense
economic pressure and competition from agricultural producers
throughout the globe. Our competitors are found in the next
county or State and Federal regulations impacted us all
equally. However, Argentina and Brazilian farmers vying for our
domestic and international customers, we cannot afford to hand
them the competitive advantage of restricting our production
tools while importing their corn and soybeans produced with
these very same tools.
On our farm, we primarily raise corn and soybeans. Without
herbicide application, we would experience at least a 50
percent decline in our corn yields, costing well over $7,000 on
a 100-acre corn field. Further detracting from the value of the
corn is the high weed seed content and the declining quality,
both of which would result in a reduction of price.
To control weeds and produce a high quality crop, we use
Atrazine, an effective, affordable, broadleaf herbicide. Very
few other products are available that do not contain this
effective product and those that do, often recommend their use
in tandem with this affordable product. One product, Balance
Pro, is much more expensive to use, compared with the $3 per
acre cost of Atrazine. Balance Pro cost me well over $10 per
acre, an increase of $7 per acre in input cost.
A loss of insecticides would also impact my ability to
control the development of pest resistance. Warrior, one of our
more important broad spectrum, post-emergency products, is used
to control a variety of pests, including armyworm, earworm,
aphids, cutworms and others. To achieve the same control, I
would need to apply a combination of pesticides, increasing my
cost by $.00 to $7 per acre in product alone. Added to that
cost, the additional expense of multiple applications. One
product that would be a part of the combination is Capture, an
insecticide that must be applied to the soil at planting time.
This product must be applied before I can determine whether
there is an insect problem. Warrior is applied only after
evidence of insect damage appears.
As you can see, when these broad spectrum, ineffective,
inexpensive tools are taken away from Ohio and U.S. farmers, it
costs significantly more to produce crops. Use of these same
tools by growers in other countries place domestic farmers at a
disadvantage and make it more difficult to compete in the
global market.
If we are importing food produced using the very tools
eliminated for U.S. use due to safety concerns, are we really
protecting our consumers?
Process challenges. I am not a scientist and leave others
to explain the very real concerns we have with the faulty
methodologies currently promoted by EPA. I, however, have
trouble understanding why EPA is advocating regulating
pesticides at the 99.9 percentile when it means going to
extreme effort to protect individuals who consume eight pounds
of grapes per day or two quarts of apple juice and two quarts
of pear juice a day. Further, these are very unlucky people who
just happen to select grapes and juice that have the maximum
residue allowed on those products. To compound the problem,
this data cannot even be corroborated.
The lack of transparency on how decisions are being made at
EPA, as it conducts product reviews is a grave concern to
agricultural producers. Too often decisions are made before the
process is approved on how the decisions are determined and
there is very little opportunity for interested stakeholders
such as myself to participate. As much as we would like to be,
farmers and the public are not typically comfortable just
trusting that everything will be resolved satisfactorily.
We believe that if common sense and sound data and methods
are employed, there will be very few, if any, losses. However,
in the event that uses are lost, there is currently no strategy
in place for how EPA will decide which products and uses will
be eliminated. The policy dictating how this risk mitigation
will be conducted should have been determined before the first
use was canceled. It was not and this process still has not
been identified.
My final concern with the FQPA implementation process
involves how EPA anticipates transition will occur when and if
cancellation and restriction decisions are made. In addition to
a lack of strategy on how to address the transition, there are
few, if any, products to which agricultural producers can
switch. With its focus on FQPA implementation, EPA has flowed
registration of new products, thereby limiting farmer access to
new alternatives. Further, these alternatives must be
economically feasible. Trading off an effective, affordable
crop protection product for a more expensive pesticide that
does not offer the same level of protection is not realistic
for continued competitiveness of U.S. and Ohio agriculture.
For a proposed solution, we ask the EPA to employ common
sense in its approach to FQPA. A reasonable approach to the
implementation of FQPA should result in a workable outcome with
few adverse impacts. We must have a balanced, transparent
implementation of the FQPA, based on real data and not
theoretical risk, including workable strategies on risk
mitigation and transition implementation. The availability of
affordable, effective alternatives should be considered when
uses are canceled, including cancellations arrived at through
registrant negotiation.
We ask Congress to increase funding for USDA's Office of
Pesticide Management Programs and other FQPA activities. As a
full partner in the implementation of this law, USDA has been
unusually quiet on the issue, due to the lack of focus and of
funds. We depend upon USDA to communicate how crop protection
products are used, how food products are handled and to track
residue levels on domestic and imported food. This
communication is not happening.
I ask for some analysis of how it is affecting the
marketplace and our ability to compete in both the domestic and
international markets. It must be determined if FQPA is
resulting in unintended consequences such as an increase in
imports, a competitive disadvantage with our international
customers, and ultimately economic failures of U.S. farmers
without intended benefit of enhanced food safety.
I appreciate the attention of the Subcommittee on
Environment and Hazardous Materials and ask for your continued
consideration. Congressional involvement and oversight is
needed to ensure that EPA's decisions are reasonable, well
supported by reliable information and balanced as intended by
Congress when FQPA was passed. We cannot afford to further
disadvantage U.S. and Ohio farmers and turn over food
production to the rest of the world as a result of the lack of
sound science in our regulatory actions.
Thank you for the opportunity to address you and I look
forward to answering any questions. Thank you.
[The prepared statement of Terry McClure follows:]
PREPARED STATEMENT OF TERRY MCCLURE, AGRICULTURAL PRODUCER
Mr. Chairman and members of the Committee, my name is Terry
McClure, a partner with my family in McClure Farms in Grover Hill, Ohio
located in Paulding County. I also currently serve as President of the
Ohio Farm Bureau Federation, the state's largest farm organization. Our
family farm raises corn, soybeans and wheat on 2,700 acres. As a
responsible user of these products, I depend upon these tools to
control weed and pest problems and provide the world and U.S. consumer
with a safe, nutritious, affordable food supply.
I thank Chairman Gillmor and the subcommittee for the opportunity
to share my concerns regarding the implementation of the Food Quality
Protection Act of 1996. I also have the privilege of sharing with you a
letter containing the perspective of thirteen county Farm Bureau
presidents in Representative Gillmor's district and I ask to have it
included in the record.
OVERVIEW
The Farm Bureau and its members dedicated time and effort to
communicating the benefit of the passage of the Food Quality Protection
Act (FQPA). For years we struggled with the unworkable Delaney Clause
which specified zero tolerance for pesticide residue on food products.
As technology improved and our ability to detect residues increased,
zero tolerance became infeasible and unrealistic. Implementation of
FQPA by the Environmental Protection Agency (EPA) however may result in
unnecessary restrictions or cancellation of many of the critical crop
protection products used in agriculture. As EPA proceeds with the
reevaluation of tolerances as required by FQPA, it is vital that it not
base these adverse actions against an existing tolerance on
unreasonable or unreliable assumptions, sketchy information or
unrealistic models, in place of sound scientific data and policies.
Ohio agriculture is a $73 billion component of the state's economy
and is important to its continued viability. Here in Representative
Gillmor's district, agriculture accounts for $6.6 billion in economic
output and employees nearly 81,000 Ohioans. We have a unique
agriculture in Ohio with typical Midwestern production of grains and
oilseeds produced along side a wide variety of vegetables, fruit,
mushrooms and even wine production. Livestock is an integral part of
our agricultural economy, depending upon the production of feedstuffs
and the proximity to the eastern market. Yet, virtually all of Ohio
agriculture is, in some form or another, dependent upon crop protection
products for its success and will be affected by the decisions EPA
makes in determining the process by which these important tools will be
reviewed.
Assuring that this process is done correctly is a top priority for
the Ohio Farm Bureau Federation. To date, our fruit and vegetables
growers have been most affected with the current review of the
organophosphates (OPs), the most highly used insecticides in the United
States. An Ohio Farm Bureau Federation-conducted survey of Guthion
(azinphos methyl) use indicated that Ohio's fruit and vegetable
producers depended upon its use to control pests on 22 Ohio crops; U.S.
EPA plans to cancel 18 of these uses. This past week EPA and
registrants negotiated cancellation of 23 uses of Guthion including
many in Ohio. Growers indicated significant losses would result from
the cancellation of this product given the zero to limited alternatives
available.
In December 1999, EPA conducted their preliminary risk assessment
for Lorsban (chlorpyrifos). Ohio agricultural producers count on
Lorsban insecticide to defend more than 30 different crops from insect
attack. In Ohio, where corn rootworm is the primary insect problem for
corn growers, Lorsban is the most effective and safe product to control
this damaging pest and is vital to soybean growers' control of
spidermite outbreaks. While we are appreciative that EPA chose to
eliminate household and residential uses rather than agricultural uses,
it highlights our concern for corn and soybean growers.
As FQPA implementation moves forward, our concern rests with the
understanding that OPs are just the first pesticide class to be subject
to review and reassessment. As other pesticide classes are reviewed,
the reassessment will be approached in much the same manner and adhere
to the same policies currently under development. How these policies
are developed is crucial and must be health protective without being
unnecessarily conservative.
If these policies are not correctly developed and fail to follow
sound methodologies and utilize good data during this first round,
inadequacies in the approach will only be magnified in subsequent
reviews. According to the EPA website there are 13,000 tolerances to be
reassessed. To date only a little over 3,800 have undergone review. Yet
to be reassessed are the bulk of pesticide uses, many of which are
crucial to agricultural production.
The Ohio Farm Bureau Federation takes food safety seriously. We
understand that the consequence of not being suitably conservative in
estimating the effects of pesticides are serious and we believe they
are understood. However, the risk of being too conservative is very
real. The production of a safe, nutritious, abundant and affordable
food supply depends upon the use of pesticides. Restrictions that
negatively affect the availability and affordability of food means less
access to the healthful foods necessary to a good diet. This kind of
negative impact also disproportionately affects lower income families
who already struggle to provide an adequate supply of fresh fruits and
vegetables for their children.
Any approach to pesticide risk assessment must be based on sound,
not speculative theoretical principles, must incorporate the highest
quality data, and have an appropriate--but not excessive--degree of
conservatism.
PROCESS CHALLENGES
The primary policy approaches that are a concern to agricultural
producers are: assuring the use of good data and methodologies, a fair
and transparent decision-making process that is open for public
involvement, and an unacceptable practice of using unduly conservative
endpoints, safety factors and default assumptions. EPA must give higher
priority to making sound scientific decisions than to completing final
tolerance reassessments by statutory deadlines and must develop a clear
strategy for transition and risk mitigation. EPA must redress the
current resource imbalance between tolerance reassessment and new
chemical/new use registration and accelerate the pace of making
decisions on new products and uses.
I am not a scientist and leave others to explain the very real
concerns we have with assuring the use of sound methodologies. I,
however, can understand the problems of indiscriminately applying extra
safety factors to products that are already subject to considerable
safety adjustments. I also have trouble understanding why EPA is
advocating regulating pesticides at the 99.9 percentile when it means
going to extreme efforts to protect such individuals as infants who
consume eight pounds of grapes per day or two quarts of apple juice AND
two quarts of pear juice a day. Further, these are very unlucky people
who just happen to select grapes and juice that have the maximum
residue allowed on products. To compound the problem, this data can not
even be corroborated.
The lack of transparency (or the lack of clarity) on how decisions
are being made by EPA on conducting reviews of products is a grave
concern to the agricultural producers. Too often decisions are being
made before the process is approved on how the decisions will be made.
Compounding this difficulty is EPA's apparent rush to complete the next
phase of FQPA implementation, the cumulative risk assessment, by August
3, 2002. The pressure to complete this phase is brought by the need to
meet the next statutory deadline in FQPA and to meet a deadline in a
settlement decree with the Natural Resources Defense Council that was
signed in the 11th hour of the Clinton Administration. As much as we
would like to be, farmers, and the public, are not typically
comfortable just trusting that everything will be resolved
satisfactorily.
We believe that if common sense and sound data and methods are
employed, there will be very few, if any, losses. However, in the event
that uses are lost, there is currently no strategy in place for how EPA
will decide which products and uses will be eliminated. The policy
dictating how this risk mitigation will be conducted should have been
determined before the first use was cancelled. It was not and this
process still has not been identified. Today agricultural producers
have faced, and are facing, cancellations with no idea how EPA arrived
at which uses to cancel.
My final concern with the FQPA implementation process involves how
EPA anticipates transition will occur when and if cancellation and
restriction decisions are made. To date, EPA lacks a strategy for how
to address transition, or the move to other pest control tools and
methods. As discussed earlier, it is our belief that with the
incorporation of sound science in the implementation process,
transition will not be necessary, but if it is, it is imperative that
users of these products know and understand what process EPA plans to
use to facilitate transition to other products.
Transition, however, will require products to which agricultural
producers can switch. With its focus on FQPA implementation, EPA has
had a very real slow-down in the registration of new products. With
fewer new products being registered, new alternatives are not available
to farmers. Further, these alternatives must be economically feasible.
Trading off an effective, affordable crop protection product for a more
expensive pesticide that does not offer the same level of protection is
not realistic for the continued competitiveness of U.S. and Ohio
agriculture.
I have already referenced that EPA is now moving into the next
phase of FQPA implementation with its cumulative risk assessment. It is
an excellent example of the concerns I have outlined. Rather than
follow the current course, a common-sense approach would dictate that
EPA avoid the use of extreme toxicity endpoints, population percentiles
and added safety factors and combining these policies to unnecessarily
restrict uses. It makes sense that EPA use an appropriate 100-fold
safety factor that protects our sensitive population not apply an
unneeded additional safety factor that would add no real protection but
would wipe out registered uses. EPA should join with every other
regulating agency and world organization and reject the 99.9th
percentile as the basis for regulation. Numerous scientific
institutions show that regulating at the 99.9th percentile is no more
protective of the health of sensitive members of our population, than
regulating at a slightly lower percentile. Finally, EPA should explain
what process it will use to address ``risk'', if any, resulting from a
refined cumulative risk assessment.
While I am not an expert in these particular areas, I am an
agricultural producer who is concerned that EPA's arbitrary policy
calls, and not scientifically reviewed approaches explained with data,
will determine if I have the tools I need to produce a safe,
affordable, nutritious supply of food.
In all of these areas of concern--use of sound science,
transparency, risk mitigation, transition, and new product
registration--there is no process by which stakeholders--particularly
interested and impacted growers such as myself--can participate. If
mitigating risk by eliminating products and uses is necessary, there is
no process by which I can provide input on the uses and products that
may have to be changed or lost and the consequences of such actions on
the farmer.
HOW FQPA AFFECTS FARMING OPERATIONS
I have reviewed concerns with the process by which EPA is
implementing FQPA. Please allow me to share how these actions impact
the agricultural industry in Ohio.
The agricultural industry in Ohio and the United States is
experiencing intense economic pressure and competition from
agricultural producers throughout the globe. Once our competitors were
found in the next county or state and federal regulations impacted us
all equally. However, with farmers in Argentina and Brazil vying for
our domestic, as well as international, customers we can not afford to
continue handing them the competitive advantage of restricting our
production tools while importing their corn and soybeans produced with
those very same tools.
On our farm we primarily raise corn and soybeans. In corn
production we utilize herbicides to control broadleaf weeds. Without
herbicide application our yields would be considerably cut--we would
anticipate losing at least 50 percent of our corn crop, which on a 100-
acre cornfield would cost approximately $7,000. Further detracting from
the value of the corn produced is the high level of weed seed in the
grain and a decline in quality, both of which would result in a
reduction in price.
To control weeds and produce a high quality crop, use Atrazine, an
effective, affordable broadleaf herbicide. Losing Atrazine would
devastate our weed control program. Very few other products are
available that do not contain this effective product and those that are
often recommend their use in tandem with this affordable product. One
product, Balance Pro (isoxaflutole), is recommended to be used in
conjunction with Atrazine, is much more expensive to use. Compared to
the $3.00 per acre cost of Atrazine, Balance Pro costs me over $10.00
per acre--an increase of $7.00 per acre in input cost.
A loss of insecticides would also impact my ability to control the
development of pest resistance. One of more important broad spectrum,
post-emergence products is Warrior. It is used to control a variety of
pests, including armyworm, earworm, aphids, cutworms and others. To get
the same control, I would need to apply a combination of pesticides,
increasing my costs by $4.00 to $7.00 per acre in product alone. Added
to that cost is the additional expense of multiple applications.
Further one product that would be a part of the combination would be
the use of Capture, an insecticide that must be applied to the soil at
planting time. This product must be applied at a time that precedes my
ability to determine if I will have insect problems for the year.
Warrior is applied only after evidence of insect damage appears.
As you can see, when these broad-spectrum, ineffective, inexpensive
tools are taken away from Ohio and U.S. farmers, it costs significantly
more to produce our crops. Use of these same tools by growers in other
countries keep their input costs stable, placing domestic farmers at a
disadvantage and making it more difficult to compete in the global
market.
If we are importing food products, whether they are grains,
oilseeds, or fruits and vegetables, that are produced using the very
tools that were eliminated because of a concern over safety, are we
really protecting our consumers? The fruit and vegetable industry has
seen huge increases in imports. Overall imports of fruits and
vegetables, fresh and processed, have increased from 9.5 percent of
U.S. consumption in 1977-79 to 20.1 percent in 1999. (All data on
market shares are from ERS-USDA.) Imports play a much larger role in
the overall fruit market, 33.6 percent in 1999, than in the vegetable
market, 10.1 percent in 1999. Does handing this kind of competitive
advantage to our competitors truly result in an increase of food safety
or does it simply reassign our food production offshore?
PROPOSED SOLUTION
We ask EPA to employ common sense in its approach to FQPA. A
reasonable approach to the implementation of the Food Quality
Protection Act, based on real data and not theoretical risk should
result in a workable outcome with few adverse impacts. We must have a
balanced, workable and transparent implementation of the Food Quality
Protection Act based on sound science. Regulatory decisions must be
made using reliable information and actual data; they must not disrupt
agricultural production and not undermine our competitiveness in
international markets.
Transparency in the process of how EPA is reviewing these products
and opportunities for stakeholder participation is vital. There needs
to be a transparent process established with affected stakeholders'
input before any risk mitigation is contemplated.
We must have workable strategies on how EPA will mitigate risk and
select what uses will be lost as well as how transition will occur. The
availability of affordable effective alternatives should be considered
when uses are cancelled; including the cancellations arrived at by
negotiating with registrants.
We ask Congress to increased funding for USDA's Office of Pesticide
Management Programs and other FQPA activities. USDA was intended to be
a full partner in the implementation of this law, but a lack of funds
and focus have made USDA unusually quiet on this issue. We depend upon
the experts at USDA to communicate information regarding how crop
protection products are used, how food products are handled, and
tracking residue levels on domestic and imported food. This
communication does not appear to be happening.
I ask for some analysis of how it is affecting the marketplace and
our ability to compete in both the domestic and international markets.
This analysis should determine whether FQPA is resulting in unintended
consequences such as an increase in imports, a competitive disadvantage
with our international customers and ultimately, economic failures of
U.S. farmers without the intended benefit of enhanced food safety.
I appreciate the attention of the Subcommittee for the Environment
and Hazardous Materials and ask for your continued consideration.
Congressional involvement and oversight is needed to ensure that EPA's
decisions are reasonable, well supported by reliable information and
balanced as intended by Congress when FQPA was passes. We cannot afford
to further disadvantage U.S. and Ohio farmers and turn over food
production to the rest of the world as a result of the lack of sound
science in our regulatory actions.
Thank you for the opportunity to address you here today.
Mr. Gillmor. Thank you, Mr. McClure. Ms. Schmenk.
STATEMENT OF CHRISTIANE W. SCHMENK
Ms. Schmenk. Thank you very much, Chairman Gillmor, for
inviting me to testify today. My name is Chris Schmenk and I am
Director of Environmental Stewardship for The Scotts Company.
Scotts is headquartered in Marysville, Ohio, which is just a
couple of hours south of here, and was founded there in 1868.
We employ approximately 1,000 employees here in Ohio and about
3500 worldwide. Scotts is the world's leading producer and
marketer of products for the do-it-yourself home and garden
care market, and we also have an emerging lawn care business.
Our brands include Turf Builder, Miracle-Gro, Ortho, Roundup,
Osmocote and Hyponex. I will therefore speak to you today, both
as a formulator of products registered with the EPA and as an
end-user as well. Regarding the format of my testimony, I will
first express concerns that Scotts, as a member of the
industry, has with the implementation of the FQPA. I will then
speak to you as a representative of an Ohio-based residential
use company that depends on sound regulation to stay in
business. Finally, I will conclude my comments with specific
recommendations for the committee to consider in light of the
approaching FQPA deadlines.
Regarding the implementation process, Scotts has been
involved since the Act was enacted in 1996. The EPA has been
willing to include Scotts and industry from the beginning and
we are very appreciative of that. We have found a genuine
willingness at the Agency to listen to our positions and to
involve us in decisionmaking. We support the law's goals to
provide additional protection for children, as well as new
assessments regarding aggregate and cumulative exposure.
However, from the beginning of the implementation process,
it became clear that many of the FQPA's new requirements could
not be met for many years because the science needed to
implement many of the law's provisions had not yet been
developed. As of today, a great deal of the science still has
not been developed, despite the hard work of both the EPA and
pesticide registrants. Scotts is very concerned that as we near
those impending deadlines, most notably the August 3, 2002
deadline for the cumulative risk assessments of OPs, we will
needlessly lose the use of important pest management tools.
Scotts works hard to ensure that our products meet the highest
possible safety standard. As you know, all products registered
before 1984 have to go through a reregistration and tolerance
reassessment process that is as rigorous as the process for
registering new products. This is part of a superb regulatory
system that ensures the highest possible standards of safety
for all citizens, particularly our children. The pesticide
review process was excellent before 1996 and it is even
stronger today. However, we are concerned that in recent years
decisions about registered uses of pest control products may
not have been entirely based on science. Anti-chemical emotions
seem to have caused science to be disregarded in certain
instances. Today, we ask for your help in ensuring that
approved uses of safe and reliable pest management tools are
not lost, and that all decisions made are based on scientific
evidence.
I would like to next speak briefly on the use of data that
has been developed by registrants. Scotts has been a leader in
acquiring and delivering data to the EPA to support the
continued registration of residential use pesticides. Scotts
joined and is an active participant in the Outdoor Residential
Exposure Task Force and we have also participated in a
Residential Exposure Joint Venture Task Force in order to
generate accurate data about adult and child exposures. The EPA
has incorporated some registrant-generated data into its risk
assessments; however, there are still instances in which the
EPA is using default assumptions rather than the available,
reliable data that has been generated by these task forces and
individual pesticide registrants.
We hope that the EPA will incorporate this and other actual
data in making their decisions, rather than using these default
risk assumptions in order to more accurately assess exposures.
Next, I would like to talk briefly about overly
conservative assumptions. Another concern that Scotts and
members of industry have is that the residential portion of the
process established by the FQPA for risk assessment includes
several overly conservative assumptions that when fully
incorporated into a risk assessment will eliminate many
important pest control tools. For example, the EPA currently
uses an oral hand-to-mouth exposure scenario to estimate the
amount of exposure that a child may receive from touching a
treated surface, such as a lawn or carpet and then placing his
or her hand in their mouth. Our concern as a formulator and
user of outdoor pest control products is that the EPA's
exposure estimates were based on the results of an indoor
videography study. The reality is that studies show that
outdoor play results in children putting their hands in their
mouths far less frequently than passive indoor activities.
This is just one example of where the EPA has over-
estimated residential exposure, resulting in the risk cup
becoming fuller unnecessarily. The Outdoor Residential Exposure
Task Force will be submitting actual data to the EPA on outdoor
hand-to-mouth activity in April. It is essential that this
actual data be incorporated into the final OP cumulative risk
assessment.
I will next comment briefly on two additional undecided
science issues that could greatly impact the EPA's cumulative
risk assessment. And these are the percentile of regulation and
the application of the FQPA uncertainty factor.
The decisions made in the cumulative risk assessments
depend, in large part, on how the EPA chooses to address these
and other science policy issues. My colleague, Mr. McClure,
spoke previously on the level of regulation, so I will not
spend much time on that, but I will just comment that no other
regulatory agency in the United States or the World Trade
Organization regulates at the 99.9 percentile. Statisticians
find no statistical difference between the 99.9 and 99.5
percentile and, according to the CDC and the USDA, current food
consumption data used by the EPA in pesticide risk assessment
cannot be used to reliably predict consumption percentiles over
the 95th percentile. If the EPA uses a 99.9 standard for the
cumulative assessments, uses and products could be
unnecessarily lost without providing any additional protection
of public health.
Regarding the FQPA uncertainty factor, the FQPA provided
that if the EPA lacks complete and reliable data to assess the
risk of pesticides on infants and children, it could add a
safety or uncertainty margin of ten-fold. The EPA has not yet
decided whether it will add an additional tenfold uncertainty
factor to the overall cumulative assessments for the OPs. The
Agency could choose to add anything from an additional 2 to a
10 times factor.
As I previously stated, the uncertainty factor was intended
for use when there was a lack of reliable or incomplete data.
However, that is not the case for OPs. The EPA has more than
adequate amounts of data on how OPs work and there is no
uncertainty about the common mechanisms for which they are
being grouped together. Therefore, there is no need for an
additional uncertainty factor to be applied.
Finally, Scotts is concerned about the timing of these
science decisions. The EPA committed through CARAT to release a
revised risk assessment methodology for public comment in June.
While Scotts greatly appreciates the EPA's commitment to
release this for public comment, it would have been much more
timely for all stakeholders if it had been released earlier
this spring. A June release will not provide adequate time for
the EPA to meaningfully assess all public comment submitted and
to make any appropriate or necessary changes before the August
3 deadline.
Finally, I will speak about Scotts in particular. Scotts
has felt firsthand the impact of the FQPA. In 2000, residential
uses of two key pest control active ingredients, chlorpyrifos
and diazinon were voluntarily canceled during the tolerance
reassessment process due to fears of the registrants that they
could not meet the incredibly high theoretical risk hurdles set
by the EPA when faced with impending deadlines. These were
broad-spectrum ingredients that effectively controlled a wide
range of pests. The number of remaining active ingredients that
can effectively manage the pests controlled by these two
product is extremely limited.
Scotts not only was required to reformulate various
products in our do-it-yourself business to replace these
effective ingredients, but we also lost the use of them in our
lawn care service business. Since there are no replacements
that last as long or are as effective, we have to make more
applications of a wider variety of pesticides in order to
properly control pests. We estimate that our costs will rise at
a minimum of 25 percent and perhaps as much as 50 percent in
our lawn care service business.
It is essential that other key active ingredients are not
lost unnecessarily by the use of exaggerated default
assumptions rather than reliable data.
Scotts understands the pressures faced by the EPA and we
have been able to work cooperative with the Agency regarding
the discontinuance of two other OPs for use on lawns, malathion
and acephate. Fortunately, there were acceptable substitute
pest controls for use on lawns available to replace these, so
the public was not unduly harmed. However, we are also
concerned on a broad scope, as I think said by the previous
witness, by the harmful precedence that might be set if the EPA
does not use sound science in its assessment of OPs. Other
classes of pest control products are currently or soon will be
assessed under the FQPA. And if actual data is not used and
overly conservative default assumptions are used instead, we
will lose the ability to provide effective pest control
products to our customers.
In conclusion, I would like to thank the committee for
holding this hearing and I would like to ask for your
assistance in several areas. It is essential that as the EPA
moves forward with FQPA implementation, that you offer them
your support so that they continue to do the following:
To use accurate, real-world data and sound science, rather
than hypothetical models and exaggerated exposure assessments.
And second, that you ask them to consider and incorporate
all available actual data into the tolerance reassessment
process even though there is an August 3 deadline approaching.
If this approaching deadline causes this data not to be used,
it could result in the further loss of effective, safe and
thoroughly tested products. It is important to remember that
these products are used for a reason, to control pests, and
that true pest management is not possible without these tools.
Removing these tools from the market will hurt our economy,
will hurt businesses like Scotts, will needlessly expose
children to pests and will deny consumers access to safe pest
control choices.
Thank you.
[The prepared statement of Christiane W. Schmenk follows:
PREPARED STATEMENT OF CHRISTIANE W. SCHMENK, THE SCOTTS COMPANY
Thank you very much, Chairman Gillmor, Congressman Pallone and
other members of the subcommittee for inviting me to testify today. My
name is Chris Schmenk, and I am Director of Environmental Stewardship
for The Scotts Company. Scotts is headquartered in Marysville, Ohio and
was founded there in 1868. We employ approximately 1000 employees in
Ohio and about 3500 worldwide. Scotts is the world's leading producer
and marketer of products for do-it-yourself lawn and garden care. Our
products and brands include Turf Builder, Miracle-Gro, Ortho, Roundup,
Osmocote and Hyponex. We also have an emerging lawn care business for
those who would rather hire us to apply their lawn, tree and shrub care
products. I will therefore speak to you today as both a formulator of
products registered with the EPA and as an end-user of products.
Regarding the format of my testimony, I will first express concerns
that Scotts, as a member of industry, has with the implementation of
the Food Quality Protection Act (FQPA). I will then speak to you as a
representative of an Ohio-based company that depends on sound
regulation to stay in business. Finally, I will conclude my comments
with specific recommendations for the Committee to consider in light of
approaching FQPA deadlines.
IMPLEMENTATION PROCESS
As a formulator of numerous specialty pest control products, Scotts
has been involved in the FQPA implementation process since President
Clinton signed the bill into law in 1996. The EPA has been willing to
include Scotts and industry in the implementation process from the
beginning, and we are very appreciative of that. We have found a
genuine willingness at the Agency to listen to our positions and to
involve us in decision-making. When the FQPA was originally passed,
Scotts and other registrants and users of pesticides were aware that
the law's new requirements would require registrants to perform
additional tests and gather new data concerning pesticide use and
exposure. While we support the law's goals to provide additional
protection for children, as well as new assessments regarding aggregate
and cumulative exposure, we also recognize that the law gave the EPA a
vast amount of discretion on how to implement these goals.
From the beginning of the implementation process, it became clear
that many of FQPA's new requirements could not be met for many years
simply because the science needed to implement many of the law's
provisions had not yet been developed. Almost six years later, a great
deal of the science has still not been developed, despite the hard work
of the EPA and pesticide registrants. Scotts is very concerned that as
we near impending deadlines imposed by the FQPA, most notably the
August 3, 2002 deadline for the cumulative risk assessment of
organophosphates (OP's), we will needlessly lose the use of important
pest management tools. Scotts spends an enormous amount of time and
energy to make sure our products meet the highest possible safety
standards. It is clear that the pesticides on the market today are
rigorously tested before approval and do not pose health threats to the
public. The average pesticide takes over 10 years to register and must
pass over 110 vigorous tests conducted under stringent laboratory
practices mandated by the EPA. On average, the development of new
pesticide products can cost up to $150 million to get from the lab to
the market.
All products registered before 1984, have to go through a
reregistration and tolerance reassessment process that is as rigorous
as the process for registering new products. This system of
registration and reregistration is part of a superb regulatory system
that insures the highest possible standards of safety for all citizens,
particularly our children. The pesticide review process was excellent
before 1996 and is even stronger today. Scotts supports the continued
strengthening of this process, and we have no interest in selling or
using any products that pose hazards to our customers. We are also very
much in favor of a safe food supply for our nation. However, we are
concerned that in recent years, decisions about registered uses of pest
control products may not have been based entirely on science. Anti-
chemical emotions seem to have caused science to be disregarded in
certain instances. Today, we ask for your help in ensuring that
approved uses of safe and reliable pest management tools are not lost,
and that all decisions made are based on scientific evidence.
DATA DEVELOPMENT
The Scotts Company has been a leader in acquiring and delivering
data to EPA to support the continued registration of residential-use
pesticides. Scotts joined and is an active participant in the Outdoor
Residential Exposure Task Force (ORETF) and participated in the
development of the Residential Exposure Joint Venture Task Force (REJV)
in order to generate accurate data about adult and child exposures to
pesticides used in and around the home and on lawns, gardens, golf
courses, and playgrounds. The EPA has incorporated some registrant-
generated data into its risk assessments; however, there are still
instances in which the EPA is using default assumptions, rather than
the available, reliable data generated by ORETF, REJV and individual
pesticide registrants.
Additional ORETF data on hand-to-mouth activities of small children
is scheduled to be submitted to the EPA in mid-April, but we are
fearful that this data will not be able to be incorporated in Agency
decisions about OP's, in the rush to meet statutory and court-ordered
deadlines. We hope that the EPA will incorporate this and other actual
data generated in the near future into its final risk assessments of
OP's, rather than using default risk assumptions, in order to more
accurately assess exposures. Statutory and court-ordered deadlines for
implementation of the FQPA requirements must not be an excuse to
disregard reliable data generated by registrants. We are all learning
in this implementation process, and the task of putting together
mathematical models to assess risk has been enlightening to both
industry and the Agency. In order to avoid the needless loss of
pesticide uses, the implementation process should allow the EPA to be
flexible so that it can use these real data, rather than exaggerated
default assumptions.
OVERLY CONSERVATIVE ASSUMPTIONS
Another concern that we would like to bring to your attention is
that the residential portion of the process established by the FQPA for
cumulative risk assessment includes several overly conservative
assumptions that when fully incorporated into a risk assessment would
eliminate many important pest control tools. For example, the EPA
currently uses an oral hand-to-mouth exposure scenario to estimate the
amount of exposure a child may receive from touching a treated surface
such as a lawn or carpet and then placing his hand in his mouth. Our
concern as a formulator and user of outdoor control products is that
the EPA's exposure estimates were based on the results of an indoor
videography study. The study only considered the frequency of hand-to-
mouth occurrences of children playing indoors, yet it has been used to
estimate hand-to-mouth occurrences for children playing both indoors
and outdoors. The reality is that studies show that outdoor play
results in children putting their hands in their mouths far less
frequently than passive indoor activities. ORETF will be submitting
actual data to the EPA on outdoor hand-to-mouth activity in April. It
is essential that this type of data be incorporated into the final OP
cumulative risk assessments.
The EPA's assessments have assumed that when children play on turf,
they pick up 5% of any pesticide residue present each time their hands
come into contact with the turf, and that this 5% is subsequently
ingested, resulting in an ingestion of 5% of all of the pesticide that
had been applied. Scientific analysis shows that this 5% figure is
greatly over-stated.
These examples are just a few ways in which the EPA's OP cumulative
assessment overestimates residential exposure, resulting in the ``risk
cup'' becoming fuller unnecessarily. Reliable data, not default
assumptions, must be used to ensure that the risk cup is not filled
with unsubstantiated ``theoretical risk.'' Scotts is very concerned
that if this reliable data is not used, our uses of these control tools
will be lost.
I would also like to take this opportunity to comment on two
additional undecided science issues that could greatly impact EPA's
cumulative risk assessments--the percentile of regulation and the
application of the FQPA uncertainty factor. The impact of the
cumulative risk assessment on the availability of vital pest control
uses depends in large part on how EPA chooses to address these and
other science policy issues. Both of these decisions are policy calls
that the EPA will make in the next few months, and they will determine
whether key products remain available to Ohio companies such as Scotts.
PERCENTILE OF REGULATION
When we speak of the level of regulation, we are referring to the
percentage of the population used in exposure estimates. If the EPA
bases exposure estimates on 99.9 percent of the population, as it did
in the individual chemical assessments under the FQPA, risk mitigation
will appear to be necessary, even though no additional protection is
needed. No other regulatory agency in the United States or the World
Trade Organization regulates at the 99.9th percentile. Statisticians
find no statistical difference between the 99.9 and 99.5 percentiles,
and according to the CDC and the USDA, current food consumption data
used by the EPA in pesticide risk assessment cannot be used to reliably
predict consumption percentiles over the 95th percentile. If the EPA
uses a 99.9 standard for the cumulative assessments, uses and products
could be unnecessarily lost without providing any additional protection
of public health.
Further, EPA's current practice of combining the maximum exposures
from each exposure route to represent the combined exposure for the
population is another area of concern. A child with dermal exposure
from treated turf at the 99.9th percentile is probably not the same
child whose hand-to mouth oral exposure is at the 99.9th percentile and
is also not the same child whose dietary exposure is at the 99.9th
percentile. Combining these exposure values to represent a single child
at the 99.9th percentile is needlessly overprotective since such an
individual is unlikely to exist. This overly-conservative practice,
combined with the safety factors and the percentile of regulation used
in cumulative assessments will result in additional, unnecessary loss
of safe and effective products for the residential environment.
FQPA UNCERTAINTY FACTOR
EPA's application of the FQPA Uncertainty Factor is another science
policy issue that could result in the needless cancellation of
pesticide uses. According to a February 28, 2002 EPA draft guidance
document, ``Consideration of the FQPA Safety Factor and Other
Uncertainty Factors in Cumulative Risk Assessment of Chemicals Sharing
a Common Mechanism of Toxicity,'' the EPA will continue to make
decisions about whether or not to apply additional safety factors on a
case-by-case basis. The draft goes on to state that this
``individualized determination'' may include the application of the
FQPA uncertainty factor to individual chemicals, as well as the entire
common mechanism pesticide group.
EPA has not yet decided whether it will add an additional 10x
uncertainty factor to the overall cumulative assessment for the OPs.
The agency could choose to add anything from an additional 2-10x
factor. The uncertainty factor was intended for use when there was
uncertainty about the database for a particular type of chemistry. In
the case of organophosphates, there is no uncertainty about the common
mechanism of toxicity -- cholinesterase inhibition. The EPA has more
than adequate amounts of data on how organophosphates work, and there
is no uncertainty about the common mechanism for which they are being
grouped together. For the cumulative OP risk assessment, there is no
need for an additional uncertainty factor to be applied.
The EPA committed to the Committee to Advise on Reassessment and
Transition (CARAT) to release a revised risk assessment methodology for
public comment in June. This assessment will include determinations
about the level of regulation and the application of the FQPA
uncertainty factor. While Scotts greatly appreciates the EPA's
commitment to release the revised methodology for public comment, it
would have been much timelier for all stakeholders if the EPA had
released the refined assessment process earlier this spring. A June
release will not provide adequate time for the EPA to meaningfully
assess all public comments submitted and to make appropriate changes to
the risk assessment process by the August 3rd deadline.
PRODUCT LOSS BY SCOTTS
Scotts has felt first-hand the impact of the FQPA. In 2000,
residential uses of two key pesticide active ingredients--chlorpyrifos
and diazinon- were voluntarily cancelled during the tolerance
reassessment process due to fears of the registrants that they could
not meet the incredibly high theoretical risk hurdles set by the EPA
when faced with impending deadlines. These were broad-spectrum
ingredients that effectively controlled a wide range of pests. The
number of remaining active ingredients that can effectively manage the
pests controlled by these two products is extremely limited.
Scotts not only was required to reformulate various products in our
do-it-yourself business to replace these effective ingredients, but we
also lost the use of them in our lawn care service business. Since
there are no replacements that last as long or are as effective, we
have to make more applications of more pesticides in order to properly
control pests. We estimate that our costs will rise at a minimum of
twenty-five percent, and perhaps as much as fifty percent. It is
essential that other key active ingredients are not lost unnecessarily
by the use of exaggerated default assumptions, rather than reliable
data.
Scotts understands the pressures faced by the EPA, and we have been
able to work cooperatively with the Agency regarding the discontinuance
of two other organophosphates for use on lawns, malathion and acephate.
Fortunately, there were acceptable substitute pest controls available
to replace these, so the public was not unduly harmed by these lost
uses. However, in many cases, there are no substitutes available, and
we are concerned about the ability to properly control harmful pests if
we lose important products.
CONCLUSION AND RECOMMENDATIONS
In conclusion, I would like to thank the Committee for holding this
hearing and to ask for your assistance in several areas. It is
essential that as the EPA moves forward with FQPA implementation, that
you offer them your support so that they can continue to do the
following:
Use accurate real-world data and sound science, rather than
hypothetical models and exaggerated exposure assessments;
Consider and incorporate all available data into the tolerance
reassessment process, even though there is an August 3
deadline. If this approaching deadline causes such data to not
be used, it could result in the loss of effective, safe and
thoroughly tested products. It is important to remember that
these products are used for a reason--to control pests--and
that true pest management is not possible without these tools.
Removing these tools from the market will hurt our economy,
will hurt businesses like Scotts, will needlessly expose
children to pests and will deny consumers access to safe pest
control choices.
Thank you.
Mr. Gillmor. Thank you. Mr. Marquette.
STATEMENT OF ROBERT MARQUETTE
Mr. Marquette. Thank you. Good morning, Chairman Gillmor.
Chairman Gillmor and members of the subcommittee, my is Robert
Marquette and I am the owner of Ram Exterminators in Oregon,
Ohio. I am testifying this morning as President of the Ohio
Pest Control Association and a member of the National Pest
Management Association. The National Pest Management
Association represents 5,000 pest management companies across
the United States, 122 of those companies are located right
here in Ohio.
Like pest management companies across Ohio and the rest of
the country, Ram Exterminators is a small family owned business
that manages pests such as ants, cockroaches, rodents, spiders,
stinging insects and termites in countless different settings.
Those settings include single and multi-family dwellings,
office buildings, hospitals, nursing homes, restaurants and
many other types of locales.
I appreciate the opportunity to testify this morning. I
will outline the impact that FQPA has had on our pest
management industry and express the industry's concerns about
the manner in which the U.S. EPA has implemented FQPA,
particularly during the previous administration. I will also
discuss the industry's perspective on cumulative risk
assessments.
First off, I think it is important to note that the pest
management industry strongly supported FQPA when it was enacted
in the summer of 1996. We supported the stringent health-based
standards established by FQPA and were hopeful that the law's
emphasis on using sound science and reliable data to formulate
policy would dictate the Agency's decisionmaking process. While
EPA's FQPA-related decisions have not been as rooted in sound
science as pest management industry would like, we are hopeful
that the current administration will be more committed to
implementing FQPA as Congress originally intended, and look
forward to working closely with Mr. Sharp and other Agency
officials.
As you all well know, FQPA dramatically changed the way EPA
evaluates registered pesticides. A pesticide use is no longer
looked at on an individual basis. Specifically, FQPA requires
EPA to make determination ``that there is a reasonable
certainty that no harm will result from aggregate exposure . .
. including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' One of the
other types if exposures that must be included in an aggregate
assessment is residential exposure, which covers pesticides
used in and around residences.
Residential exposure was not required prior to 1996. As a
result, such data was not widely available. Even EPA
acknowledges that the lack of residential exposure data noting
in a January 4, 1999 Federal Register notice that ``Highly
specific residential exposure data [is] generally lacking, and
there is not wide understanding and acceptance of existing
models and assumptions.''
As recently as early this month, the Agency again
acknowledged the scarcity of residential exposure data.
Fortunately, Congress recognized that certain data might
not be immediately available. That is why Congress has expanded
EPA's data call-in authority, allowing the Agency to compel
manufacturers to collect and submit this data. Since FQPA
passed, however, EPA has only exercised this data call-in
authority once for residential use products. Despite the
absence of reliable data, the Agency made significant decisions
in 1999 and 2000 about the future availability of products that
my company and other pest control operators in the United
States use to safeguard our customers from dangerous,
destructive and annoying pests.
Fewer FQPA decisions better illustrate the lack of reliable
data that leads to the unwarranted loss of products than EPA's
handling of the compound bendiocarb. Sold under the trade name
Ficam, bendiocarb was first registered with EPA back in 1980.
It had a strong safety record and was used to manage a
multitude of pests, including yellow jackets, ants and spiders.
In fact, Ficam was marketed as an excellent product to use in
sensitive accounts such as hospitals and day care centers
because it posed virtually no risk of exposure.
In the fall of 1999, however, EPA suddenly announced that
it reached a voluntary agreement the manufacturer of bendiocarb
to cancel all uses of the product December 31, 2001. This
action resulted from the FQPA-driven assessment that relied
heavily upon unrealistic worst-case scenarios. The industry
felt that this process unfairly and unjustly painted Ficam in
an unfavorable light. Relying on worst-case scenarios that
suggested that the residential exposure risks were greater than
they actually were led the Agency to request the manufacturer
to conduct a series of additional and expensive toxicity tests.
Based on the relatively limited sales of Ficam, the
manufacturer determined that the additional tests were not a
worthwhile investment. Because of the Agency's reliance on
worst-case assumptions, one of the industry's most effective
tools has been lost. Ficam was especially effective in managing
yellow jackets and other wasps. Now many operators are
uncertain as to which product they are going to use to replace
Ficam to manage these stinging insects, fearing poor results
and increased liability. In August and September, the months
that comprise the traditional yellow jacket season, will be the
first since the loss of Ficam. I can only hope that my
customers are not at a greater risk from the yellow jacket
stings because a useful tools has been unnecessarily lost.
Regarding cumulative risk, pest management industry has a
slightly different perspective than some of the others on this
panel. The fact is that practically all the PCO uses of
organophosphates were lost in the FQPA aggregate assessment,
including diazinon, malathion, chlorpyrifos, acephate, DDVP and
others. We are, however, extremely concerned about the
precedent EPA will set with its cumulative risk policy for
organophosphates. While our industry is fortunate enough to
have some viable replacements for the organophosphates that
have been lost, synthetic pyrethroids, one of the next classes
of chemicals scheduled to be reviewed under FQPA, are a staple
of our industry. Their loss would be truly devastating. But
unless EPA collects data and refines its method for estimating
risks from residential exposure, their losses are assured.
While I expressed numerous concerns during my testimony
today, I am extremely hopeful that EPA Administrator Christine
Todd Whitman will lead the Agency in a different direction that
her predecessor. In fact, I would like to commend Administrator
Whitman for being the first EPA Administrator to ever address a
structural pest management group in Washington when she spoke
to us at the National Pest Management Association last
February. Her appearance before the FPMA gives me hope that
Administrator Whitman is truly committed to opening dialog with
all the stakeholders and not just those that fit a particular
political agenda.
Again, I appreciate the opportunity to testify and look
forward to answering any of your questions.
[The prepared statement of Robert Marquette follows:]
PREPARED STATEMENT OF ROBERT MARQUETTE ON BEHALF OF THE NATIONAL PEST
MANAGEMENT ASSOCIATION AND OHIO PEST CONTROL ASSOCIATION
Chairman Gillmor and members of the Subcommittee, my name is Bob
Marquette and I am the owner of Ram Exterminators in Oregon, Ohio. I am
testifying this morning as President of the Ohio Pest Control
Association and a member of the National Pest Management Association.
NPMA represents 5,000 pest management committees across the United
States, 122 of which are located in Ohio.
Like pest management companies across Ohio and the rest of the
country, Ram Exterminators is a family-owned small business that
manages pests such as ants, cockroaches, rodents, spiders, stinging
insects and termites in countless settings, including single and multi-
family dwellings, schools, office buildings, hospitals, nursing homes,
restaurants and many other locales.
I appreciate the opportunity to testify this morning. I will
outline the impact that the Food Quality Protection Act (FQPA) has had
on the pest management industry and express the industry's concerns
about the manner in which the U.S. Environmental Protection Agency
(EPA) has implemented FQPA, particularly during the previous
administration. I will also discuss the industry's perspective on
cumulative risk assessments.
First off, I think it is important to note that the pest management
industry strongly supported FQPA when it was enacted in the summer of
1996. We supported the stringent health-based standard established by
FQPA and were hopeful that the law's emphasis on using sound science
and reliable data to formulate policy would dictate the Agency's
decision-making process. While EPA's FQPA related decisions have not
been as rooted in sound science as the pest management industry would
have liked, we are hopeful that the current administration will be more
committed to implementing FQPA as Congress originally intended and look
forward to working closely with Mr. Sharp and other Agency officials.
As you well know, FQPA dramatically changed the way that EPA
evaluates and registers pesticides. A pesticide use is no longer looked
at on an individual basis. Specifically, FQPA requires EPA to make a
determination ``that there is a reasonable certainty that no harm will
result from aggregate exposure . . . including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' One of the other types of exposures that must be
included in the aggregate assessment is residential exposure, which
covers pesticide use inside residences and on lawns.
Residential exposure data was not required prior to 1996. As a
result, such data was not widely available. Even EPA has acknowledged
that it lacks reliable residential exposure data, noting in a January
4, 1999 Federal Register notice that ``Highly specific residential
exposure data are generally lacking, and there is not wide
understanding and acceptance of existing models and assumptions.'' As
recently as an EPA advisory committee meeting earlier this month, the
Agency again acknowledged the scarcity of residential exposure data.
Fortunately, Congress recognized that certain data might not be
immediately available. That is why Congress expanded EPA's data call-in
authority, allowing the Agency to compel manufacturers to collect and
submit data. Since FQPA passed, however, EPA has only exercised its
data call-in authority once for residential use products. Despite the
absence of reliable data, the Agency made significant decisions in 1999
and 2000 about the future availability of products that my company and
other pest control operators used to safeguard our customers from
dangerous, destructive and annoying pests.
Fewer FQPA decisions better illustrate how the lack of reliable
data leads to the unwarranted loss of products than EPA's handling of
the compound bendiocarb. Sold under the trade name Ficam, bendiocarb
was first registered by EPA in 1980. It had a strong safety record and
was used to manage a multitude of pests, including yellow jackets, ants
and spiders. In fact, Ficam was marketed as an excellent product to use
in sensitive accounts such as hospitals because it posed virtually no
risk of exposure.
In the fall of 1999, however, EPA suddenly announced that it had
reached a voluntary agreement with the manufacturer of bendiocarb to
cancel all uses of the product by December 31, 2001. This action
resulted from an FQPA-driven assessment that relied heavily upon
unrealistic worst-case scenarios. The industry felt that this process
unfairly and unjustly painted Ficam in an unfavorable light. Relying on
worst-case scenarios that suggested that residential exposure risks
were greater than they actually were led the Agency to request that the
manufacturer conduct a series of additional, expensive toxicity tests.
Based on the relatively limited sales of Ficam, the manufacturer
determined that the additional tests were not a worthwhile investment.
Because of the Agency's reliance on worst-case assumptions, one of the
industry's most effective tools has been lost. Ficam was especially
effective in managing yellow jackets and other wasps. Now many
operators are uncertain as to which product they will use to replace
Ficam to manage yellow jackets, fearing poor results and increased
liability. This August and September--the months that comprise the
traditional yellow jacket control season--will be the first since the
loss of Ficam. I can only hope my customers are not at greater risk
from yellow jacket stings because a useful tool has been unnecessarily
lost.
Regarding cumulative risk, the pest management industry has a
slightly different perspective than some of the others on this panel.
The fact is that practically all the PCO uses of organophosphates were
lost in the FQPA aggregate assessment, including, diazinon, malathion,
chlorpyrifos, acephate, DDVP and propetamphos. We are, however,
extremely concerned about the precedent EPA will set with its
cumulative risk policy for the organophosphates. While our industry is
fortunate enough to have some viable replacements for the
organophosphates that have been lost, synthetic pyrethroids, one of the
next classes of chemicals scheduled to be reviewed under FQPA, are a
staple of our industry. Their loss would be truly devastating. But,
unless EPA collects the data and refines its methods for estimating
risks from residential exposure, their loss is assured.
While I have expressed numerous concerns during my testimony, I am
extremely hopeful that EPA Administrator Christine Todd Whitman will
lead the Agency in a different direction than her predecessor. In fact,
I commend Administrator Whitman for being the first EPA Administrator
to ever address a structural pest management group when she spoke at a
National Pest Management Association meeting in late February. Her
appearance before NPMA gives me hope that Administrator Whitman is
truly committed to opening a dialogue with all stakeholders and not
just ones that fit a political agenda.
Again, I appreciate the opportunity to testify and look forward to
answering any questions you may have.
Mr. Gillmor. Thank you, Mr. Marquette. Mr. Zellers.
STATEMENT OF JEFFREY ZELLERS
Mr. Zellers. Mr. Chairman, my name is Jeffrey Zellers, vice
president of K.W. Zellers & Son, Inc., located in Hartville,
Ohio. Our family grows, packs and ships fresh salad vegetables
seasonally from the middle of May through the middle of
October. These vegetables, produced on 1100 acres, are
distributed throughout the eastern United States. And the
gentleman from USDA referred to minor crops, I would be a
producer of minor crops.
I appreciate the opportunity to testify and share with you
concerns I have developed from following the implementation of
the Food Quality Protection Act since its passage in 1996. I am
a concerned agricultural producer who has responsibly used
these products for years.
The process by which FQPA is implemented is critically
important. Currently under review are the organophosphates, or
OPs as a group, are the most highly used insecticides in the
United States, and their use on my farm is extremely important
in our ability to competitively produce a safe, affordable,
nutritious product. OPs such as dimethoate, diazinon,
chlorpyrifos or Lorsban and azinphos methyl, common name
Guthion, are products crucial to our ability to effectively
provide the quality of products our customers demand. It is
crucial that the final version be health protective without
being unnecessarily conservative.
While the consequences of not being sufficiently
conservative in predicting the effects of pesticides are
understood, it should be noted excessively conservative risk
analysis could unnecessarily limit the availability of products
essential to growing vegetables on our farm. This over-
estimation could unintentionally increase the cost and reduce
the availability of healthy vegetables as well as grains and
fruits, poorly serving public health.
I am concerned about the unnecessary elimination of OPs and
other crop protection products for several reasons: First,
there is a current lack of alternatives for many of the
products for which EPA is proposing cancellation. Guthion is
one of the most important products used on our farm. We
currently use it to control carrot weevils on curly and Italian
parsley. The carrot weevil will burrow into the root of the
parsley, destroying the root system and making the product's
quality unacceptable to my buyers. These varieties of parsley
gross $15,000 to $30,000 per acre and are subsequently amongst
our most important crops. Pest control alternatives are
available until our normal summer temperatures of 80 degrees
Fahrenheit and above arrive. At those temperatures, Guthion is
the only product that controls carrot weevils. EPA is proposing
the immediate cancellation of Guthion use on parsley. And it is
my understanding that that may have happened last week, I'm not
clear on that, Mr. Chairman.
Second, I, along with other--with many producers throughout
Ohio and the United States implemented integrated pest
management program. This is a program designed to eliminate
insect, disease and weed pest problems, not eradicate all
pests. It means applying pesticides, fertilizers or irrigation
only when the benefits outweigh the costs so we utilize less
pesticide product and reduce a pest's likelihood of developing
resistance to a particular product. In implementing an IPM
program, we rotate the use of pesticides as well as consider
other pest management options, including natural, biological
and cultural methods.
When our pesticide options are reduced to simply one
product to control a particular pest on a specific crop, our
IPM program suffers and its benefit declines. Dimethoate is a
critical tool used on our operation to control aster
leafhoppers on leafy lettuces. When we have been unable to
spray due to weather difficulties, aster leafhoppers which
carry the infectious aster yellows virus have destroyed two-
thirds of our lettuce corp resulting in a $4,000 loss per acre.
Dimethoate is the most effective, affordable product and the
only chemical that effectively controls this pest. We have
access to Sevin, the only other product available for
leafhoppers, but its repeated use results in resistance
development among pests and kills all the friendly predator
insects upon which we depend. Killing our friendly predator
insects defeats the objective of an effective IPM program.
Third, competition from other nations in agricultural
production continues to increase. And now I am facing
restricted access to the same tools Canadian and other overseas
growers have. As the broad-spectrum, inexpensive, effective
tools I currently use are taken away from me, it costs me
significantly more to grow my crops. Yet foreign growers are
still able to use these materials, further widening the
competitive gap and my ability to compete in this global
market, all without raising the level of food safety.
The competitive advantage we are handing to our
international competitors through the current FQPA
implementation path, we will continue to import more food where
we have no control over how it is produced nor how the workers
that help grow and harvest the crops are treated. To date, .7
percent of fresh fruits and vegetables are directly inspected.
If no residue is found on imported fruits and vegetables, they
are considered to have no residue. For U.S. products, if no
residue is found, EPA still assumes that there is half the
applied level of residue on the food product. Under current
FQPA implementation, zero does not equal zero unless it is
imported.
The intention of FQPA has been stated as enhancing the
safety of our food supply. As a vegetable grower and a father
of two young children, I would be the first person to support
implementation if I believed it resulted in increased
protection of our food supply. If sound science shows that the
environment or public health is at risk, I will be the first
one to campaign for cancellation of a pesticide.
Proposed solutions--a reasonable approach to the
implementation of FQPA, based on real data and not theoretical
risk should result in a workable outcome that does not disrupt
agricultural production or undermine our competitiveness in
international markets.
I ask for a common sense approach in reviewing these
products and ask EPA to understand how products are actually
used. EPA assumes that I use the maximum dosage of crop
protection product the maximum number of times on each of my
crops. This is simply not true. My goal is to control the pest,
not eradicate them from my field. Oftentimes the very part of
our crop that receives an application is never sold to the
consumer.
We apply dimethoate to lettuce plants when they are young
and most vulnerable to the aster leafhopper. As the plant
grows, the outer leaves that received the application at least
21 days prior to harvest fall to the side and the lettuce is
harvested without the outer leaves which remain in the field.
In this case, zero residue really means zero residue.
Transparency in the process of how EPA is reviewing these
products and the opportunities for stakeholder participation is
vital. There needs to be a transparent process established with
affected stakeholders' input before any risk mitigation is
contemplated.
I ask for consideration of how FQPA is affecting the
marketplace and agricultural production. An analysis should be
done to ensure that we are not experiencing such unintended
consequences as an increase in imported food or business
failures of U.S. farmers with no additional improvement in the
food supply. The safety of our population is not advanced if we
simply reassign production to growers in other countries who do
not fall under U.S. regulatory control.
I ask for your continued attention. Congressional
involvement and oversight is needed to ensure that EPA's
decisions are reasonable, well supported by reliable
information and balanced. Unless FQPA is implemented carefully
and in a practical manner, it will cause great harm to
agriculture and compound the economic difficulties that many
farmers are currently facing.
Thank you for the opportunity to address you here today.
And I have a little blurb here if I might add, it was a
quote that I thought was very interesting, it was in a
vegetable grower magazine and the title or the article was
``Phasing Out the OPs.'' The last line here, ``The bottom line
is that pest management without OPs is quite a bit more
expensive. It is difficult to predict what sporadic or minor
pests move to the role of key pests when OPs are removed.'' And
I think that goes beyond just crop protection, it also goes to
serving public health.
Thank you.
[The prepared statement of Jeffrey Zellers follows:]
PREPARED STATEMENT OF JEFFREY ZELLERS, AGRICULTURAL PRODUCER
Mr. Chairman and members of the Committee, my name is Jeffrey
Zellers, vice-president of K.W. Zellers & Son, Inc. located in
Hartville. Our family grows, packs, and ships fresh salad vegetables
seasonally from the middle of May through the middle of October. These
vegetables, produced on 1,100 acres are distributed throughout the
eastern United States. We also operate four acres of greenhouse
primarily growing bedding plants for the wholesale market. I am here
today to share my concerns with the implementation of the Food Quality
Protection Act of 1996.
I appreciate the opportunity to testify and share with you the
concerns I have developed from following the implementation of the Food
Quality Protection Act since its passage in 1996. I am not a scientist
or a statistician, but am an agricultural producer who has responsibly
used these products for years.
OVERVIEW
The agricultural community greeted the Food Quality Protection Act
with enthusiasm because it replaced the unworkable Delaney Clause.
However, implementation of the Food Quality Protection Act (FQPA) by
the Environmental Protection Agency (EPA) may result in unnecessary
restrictions or cancellation of some vital crop protection products. It
is critical that as EPA proceeds with the reevaluation of tolerances as
required by FQPA, that it not base restrictions or cancellations of an
existing tolerance on unreasonable or unreliable assumptions, anecdotal
information or exaggerated models, in lieu of sound scientific data and
policies.
Getting this process right is critically important. Currently under
review, the organophosphates (OPs) are, as a group, the most highly
used insecticides in the United States, and their use on our farm is
extremely important to our ability to competitively produce a safe,
affordable, nutritious product. Dimethoate, diazinon, Lorsban
(chlorpyrifos) and Guthion (azinphos methyl) are four OP products
crucial to our ability to effectively provide the quality of products
our customers demand.
But OPs are just the first class to undergo this process. Several
other groups of pesticides will also soon undergo agency review, and
the approach taken with this first group of crop protection products
will, no doubt, have a large influence on the conduct of those later
reviews. It is crucial that the final version be health protective
without being unnecessarily conservative.
While the consequence of not being sufficiently conservative in
predicting the effects of pesticides are understood, it should also be
noted that there are potentially negative public health impacts of
being too conservative in their review. The manufacture, storage, and
transportation of the food we produce depend upon pesticide use to
provide an abundant, nutritious, safe, and affordable food supply.
Excessively conservative risk analyses could limit unnecessarily the
availability of products essential to growing vegetables on our farm.
Therefore, grossly overestimating the risk of these tools could
unintentionally increase the cost and reduce the availability of
healthful vegetables as well as grains and fruits, poorly serving
public health. These pesticides are also often used in non-agricultural
products that similarly benefit the public health and safety in a
variety of ways.
It is therefore important to pursue an approach to pesticide risk
assessment that is grounded on sound theoretical principles,
incorporates the highest quality exposure information and toxicological
data, and has an appropriate--but not excessive--degree of
conservatism.
IMPACT ON FARMS
I am concerned about the unnecessary elimination of OPs and other
crop protection products for several reasons. These reasons include: a
critical lack of affordable alternatives available to control pests,
the need for multiple products for successful integrated pest
management (IPM) programs and resistance control, and the severe impact
it will have on my cost of production and consequently, my ability to
compete with non-U.S. competitors.
There is currently a lack of alternatives for many of the products
for which EPA is proposing cancellation. Guthion (azinphos methyl) is
one of the more important products used on our farm. We currently use
it to control carrot weevils on curly and Italian parsley. The carrot
weevil will burrow into the roots of the parsley, destroying the root
system and making the product quality unacceptable to my buyers. These
varieties of parsley gross $15,000 to $30,000 per acre and are
subsequently, among our more important crops. Pest control alternatives
are available until our normal summer temperatures of 80 degrees
Fahrenheit and above arrive. At those temperatures, Guthion is the only
product that controls carrot weevil. EPA is proposing to immediately
cancel Guthion use on parsley.
I, along with many producers throughout Ohio and the United States
implement an integrated pest management program. This is a program
designed to eliminate insect, disease and weed pest problems--not
eradicate all pests. It means applying pesticides, fertilizers or
irrigation only when the benefits outweigh the costs so we utilize less
pesticide product and reduce a pest's likelihood of developing
resistance to a particular product. In implementing an IPM program, we
rotate the use of pesticides as well as consider other pest management
options, including natural, biological, and cultural methods.
When our pesticide options are reduced to simply one product to
control a particular pest on a specific crop, our IPM program suffers
and its benefits decline. Dimethoate is a critical tool used on our
operation to control aster leafhoppers on leafy lettuces. When we have
been unable to spray due to weather difficulties, aster leafhoppers,
which carry the infectious aster yellows virus, have destroyed two-
thirds of our lettuce crop resulting in a $4,000 loss per acre.
Dimethoate is the most effective, affordable product and the only
chemical that effectively controls this pest. We have access to Sevin
(carbaryl), the only other product available, but its repeated use
results in resistance development among pests and kills all of the
friendly predator insects upon which we depend. Killing our friendly,
predator insects defeats the objective of an effective IPM program.
Dimethoate, which costs us $2.50 per acre, is also our first line
of defense against aphid problems. An alternative for aphid control is
Provado, a new, expensive product (at $15.00 per acre) we only use as a
last resort. Because it leads to resistance development among aphids,
we only use Pravado when the pest thresholds reach a critical point.
This product is a good example of how a reduction in the selection of
chemicals would easily result in resistance build up and a need to
increase the pounds of active ingredient used.
Along with the rest of the agricultural industry, the vegetable
sector--and my farm, are facing increasing economic pressure from
competitors throughout the rest of the world. Once, my competitors were
my neighbors in Ohio and other states. Now, it's Canada, Mexico, Chile,
Central America, and for my neighbors growing apples--its China. Once
upon a time, my costs and the prices I received for my products were
both local. Now, my costs are local, but the prices I receive are
global.
Today I must worry about not only how the exchange rate makes my
products more expensive while my Canadian competitors relative price
falls, I must also be concerned about having access to the same tools
Canadian and other overseas growers have. As the broad spectrum,
inexpensive, effective tools I currently use are taken away from me, it
costs me significantly more to grow my crops. Yet foreign growers are
still able to use these materials, further widening the competitive gap
and my ability to compete in this global market.
The competitive advantage we are handing our international
competitors through the current FQPA implementation path means we will
continue to import more food where we have no control over how it is
produced, nor how the workers that helped grow and harvest that crop
are treated. Today, 0.7 percent of fresh fruits and vegetables are
directly inspected. If no residue is found on imported fruits and
vegetables, they are considered to have no residue. For U.S. products,
if no residue is found, EPA still assumes that there is half the
detectable level of residue on the food product. Under current FQPA
implementation, zero does not equal zero, unless it's imported.
As a vegetable grower and a father of two children, I would be the
first person to support this implementation if I believed it resulted
in increased protection of our food supply. If sound science shows that
the environment or public health is at risk, I will be the first one to
campaign for cancellation of a pesticide. However, if growers in other
countries can still use the same products EPA bans me from using and
the only hurdle our competitors have to cross is the residue testing at
the border, how is food safety improved? Today we in the United States
are in the midst of an obesity epidemic, especially among kids. What
children's health needs is more fruits and vegetables, not a limitation
of access to these nutritious foods or a reliance on imported fruit and
vegetables over which we have no production control.
LIMITED ABILITY TO PARTICIPATE
As an agricultural producer I have been concerned with the lack of
transparency on how EPA is conducting reviews and the process, or lack
of, by which they are conducting these reviews. EPA appears to be
rushing to complete the next phase of FQPA implementation, the
cumulative risk assessment, by August 3, 2002. The pressure to complete
this phase is brought by the need to meet the next statutory deadline
in FQPA and to meet a deadline in a settlement decree with the Natural
Resources Defense Council that was signed in the 11th hour of the
Clinton Administration. Even at this late date, there is no indication
what the bottom line of this risk assessment will be since none of the
critical policy decisions--have been made. When I make decisions on my
farm, I figure out how I am going to do something before I do it--not
after.
There is no process by which stakeholders--particularly interested
and impacted growers such as myself--can participate. If mitigating
risk by eliminating products and uses is necessary, there is no process
by which I can provide input on the uses and products that may have to
be changed or lost and the consequences of such actions on the farmer.
At the beginning of EPA's implementation of FQPA (January 20, 1997),
then Administrator for the Office of Prevention, Pesticides, and Toxic
Substances, Lynn Goldman said there would be no further data call-ins.
Why a decision to restrict information was made was not clear but was
indicative of a lack of transparency in the process and today a
restriction on data call-ins is still a policy problem.
CURRENT CHALLENGES--CUMULATIVE RISK ASSESSMENT
I have already referenced that EPA is now moving into the next
phase of FQPA implementation with its cumulative risk assessment.
Through the risk mitigation already taken, and still being taken on
individual products, we have already given up all the non-essential
uses. What is left is left because those uses are absolutely critical.
Now EPA is reviewing all of those uses again under its cumulative risk
assessment. My concern with the policy approach EPA is taking fall into
four primary areas: use of extreme measurements, indiscriminate use of
extra safety factors, unreasonable confidence levels, and lack of a
mitigation procedure.
A common-sense approach would dictate that:
1) EPA should avoid the constant use of extreme toxicity endpoints,
population percentiles and added safety factors and combining
these policies to unnecessarily restrict uses.
2) EPA should use an appropriate 100-fold safety factor that is
protective for all population subgroups. EPA should avoid
applying an unneeded additional safety factor that would add no
real protection but would wipe out registered uses. EPA's
assessment already is based on sufficient data and uses
conservative assumptions; no extra factor is needed. The FQPA
legislation gave EPA the right to judiciously apply extra
safety factors, not apply it indiscriminately.
3) EPA should not use the 99.9th percentile as the basis for
regulation. Regulating at the 99.9th percentile is no more
protective of the health of sensitive members of our
population, than regulating at a slightly lower percentile.
Even the World Health Organization and the U.S. Food and Drug
Administration does not regulate at this high a percentage. As
my college statistics professors explained it, testing at 99.9
means you are including strange data that can't be corroborated
such as a person that eats 10 pounds of grapes a day for
several days.
4) EPA should explain what process it will use to address ``risk'', if
any, resulting from a refined cumulative risk assessment.
I am not an expert in these particular areas. I am speaking about
the above concerns from the perspective of a farmer who is observing
that whole products are being retained or lost as a result of policy
calls that EPA will make--not on scientifically reviewed approaches
that are explained with data.
PROPOSED SOLUTION
I would not come before you today to share my concerns with the
current implementation if I did not have suggested solutions. As I
indicated previously, a reasonable approach to the implementation of
the Food Quality Protection Act, based on real data and not theoretical
risk should result in a workable outcome with few adverse impacts.
The American Farm Bureau Federation has extensive policy supporting
a balanced, workable and transparent implementation of the Food Quality
Protection Act based on sound science. Regulatory decisions must be
made using reliable information and actual data; they must not disrupt
agricultural production and not undermine our competitiveness in
international markets.
I ask for a common sense approach to reviewing these products and
ask EPA to understand how products are actually used. EPA assumes that
I use the maximum dosage of crop protection product the maximum number
of times on each of my crops. This is simply not true. My goal is to
control the pest, not eradicate them from my field. Often times the
very part of our crop that receives an application is never sold to the
consumer.
As I discussed earlier, one of our major crops is lettuce. We apply
Dimethoate, to lettuce plants when they are young and most vulnerable
to aster leafhoppers. As the plant grows, the outer leaves that
received the application at least twenty-one days prior to harvest,
fall to the side and the lettuce is harvested without the outer leaves,
which remain in the field. In this case, zero residue really means zero
residue.
Transparency in the process of how EPA is reviewing these products
and opportunities for stakeholder participation is vital. There needs
to be a transparent process established with affected stakeholders'
input before any risk mitigation is contemplated.
I ask for some consideration of how it is affecting the marketplace
and agricultural production. FQPA has been in place and has undergone
implementation for six years. I would ask that an analysis be done to
ensure that we are not experiencing such unintended consequences as an
increase in imported food or business failure of U.S. farmers with no
additional improvement in the food supply. The safety of our population
is not advanced if we simply reassign production to growers in other
countries who do not fall under U.S. regulatory control.
I ask for your continued attention. Congressional involvement and
oversight is needed to ensure that EPA's decisions are reasonable, well
supported by reliable information and balanced in order to avoid
disruptions in agriculture and our ability to compete effectively in
international trade. Unless FQPA is implemented carefully and in a
practical manner, it will cause great harm to agriculture and compound
the economic difficulties that many farmers and ranchers are currently
facing.
Thank you for the opportunity to address you here today.
Mr. Gillmor. Thank you very much. Let me start with a
question directed to both Mr. McClure and Mr. Zellers. EPA has
already taken substantial steps to reassess many OP tolerances,
including working with companies to voluntarily cancel the uses
of many of these products or to impose new risk mitigation
measures that impact how the products can be used.
In your view, for products which the Agency has already
substantially restricted, such as methyl parathion, Guthion,
Lorsban, are there adequate and safer substitutes currently
available that are as effective in controlling pests?
Mr. Zellers. I will go ahead and answer that, Mr. Chairman,
in regard to Guthion, if we lose that product for the
particular use that we have it for, we do not have an adequate
replacement. I talked to one of our growing personnel in our
farming operation, he told me the other product will work about
60 percent effective when the temperature is under 75. When it
goes to 80, it goes to about 20 percent. During the summer in
northern Ohio, 80 degrees is an average temperature. So in fact
for that particular compound, we do not--if we lose the
tolerance for curly parsley, we do not have a replacement in
place right now.
Mr. Gillmor. Terry.
Mr. McClure. I guess from a grain perspective--and Dr.
Brown alluded to this--ethyl bromide, which is the main
chemical that we use for stored grain, there is no replacement
for that. Sometimes the weevil and insects actually come from
the field and are not a result of bad storage practices, they
actually come in with the crop. Especially in wheat, it really
renders that wheat useless, because the heart is eaten out of
that wheat and it renders it useless for milling and there is
no known replacement for that right now. That's a huge concern
in the grain industry, certainly in this part of the country.
Mr. Gillmor. If I could once again direct to either or both
of you. In your statements, you both not only highlight the
problems and the concerns with FQPA, but you also propose
solutions to help guide implementation. I very much appreciate
both the time and the thought that you have put into this. I
know that being a farmer is a full time job, or more than that,
and that you are willing to take the time to testify today is I
think a great service that you are both doing for your
communities.
One of the recommendations in your statement is for more
transparency in the FQPA process, and it is an issue that I
have raised with EPA. In particular, how would more
transparency be of help to you and what is it about the FQPA
process that is not adequately out in the open?
Mr. McClure. Well, many times, Mr. Chairman, by the time we
hear about the process, especially down to our individual
farmers and how it is going to affect us, it is already in the
process of being changed and implemented. Some of these things
are moving at a speed that we are not getting the input that we
would like to have on it.
Mr. Zellers. An example was given, and I don't recall, one
of the other people that provided testimony here made the
comment about the initial on cumulative coming out maybe the
end of May or in June. When you are talking about an August 3
deadline, if they have a 90-day comment period or even a 30-day
comment period to assess that information before stakeholders
such as ourselves, the timeliness of that is not possible. So I
would argue myself that the process has not been transparent
enough.
And I might say, obviously the science of cumulative is
complicated but the deadlines--EPA is forced to operate within
the deadlines and one thing that we have often talked about, to
achieve a good science base and to allow the science policies
to be reviewed and not to come--you know, the cart in front of
the horse, it is difficult with the time restrictions that EPA
has and we understand that. But consequently that does not
result in a transparent process.
Mr. Gillmor. Okay, thank you. Let me go to Ms. Schmenk. As
an important business operating here in Ohio, I think the
viewpoint of Scotts is very important to all of us, and in
particular I am interested to get your candid assessment of how
USDA and EPA are doing in implementing the Food Quality
Protection Act. In your statement, you indicated some serious
concerns about FQPA and my question is are those concerns
related to the law that was passed in 1996 or are they more
relevant to EPA and USDA's implementation of the law. So put
another way, is the problem with the statute itself or is it
with the way the statute is being applied and interpreted?
Ms. Schmenk. I guess I would answer by saying a little of
both. I think the law as passed left a lot open as far as the
science had not been developed by the time the law was passed,
so a lot was left up to would that science be developed in time
to meet the deadlines that were included, and a lot was left up
to the discretion of EPA.
As far as performance, if you would phrase it that way, of
both EPA and USDA, I think one of the prior witnesses said we
have seen I think less implementation problems with the new
administration. I think we would applaud them for the openness
and the willingness to include us in the process. I would
though, however, say that I think Mr. Sharp, on behalf of EPA,
talked about the six step implementation process and it is
something that we saw when there was the deadline for August
1999, for certain things to happen, that process got compressed
and I think really the last couple steps, which provided for
stakeholder input, were rushed into a very short time period in
order to meet that deadline. And we do have that same concern
for this next impending deadline.
Relating to the USDA, I think Mr. Brown said that they feel
that there is a need for more consumption data to better assess
the risk and so I would just applaud him for acknowledging
that, I am glad to hear him make that commitment and I would
ask that you support him on that commitment and make sure that
data is obtained before decisions are made.
Mr. Gillmor. You mention in your statement a concern about
overly conservative risk assessments. Some people hear that and
they say well why should EPA not be overly conservative, we
would rather have them make an error on the side of prevention
rather than under-estimate risk. But is that too simplistic and
could you describe some of the consequences of using overly
conservative assumptions?
Ms. Schmenk. I think it is too simplistic and I think Mr.
Zellers talked about his two children, I have two children
myself, a 4 year old and a 10 year old, and you know, they are
very near and dear to my heart and I would like them to be
protected and I want the laws of our country to protect them.
But I think what we have seen is when you use--or when the EPA
uses the default assumptions instead of actual data, it does
result in more risk being assessed than is in reality there. I
think Mr. McClure talked about assumptions where, for example,
my industry, an assumption if a child is exposed in several
different ways, if all of that is added together then, that
child would be seen to be very much at risk. When that is not
the reality of how things happen.
I think another default assumption that is being used to
assess risk for children on turf, there is an assumption, a
hand-to-mouth scenario that they will ingest 5 percent of
pesticide residue and actual statistics show that it would be
far less than that. So again, if we can encourage the EPA to
wait for that actual data and to use it rather than these
default assumptions, I think we will have a much better chance
of retaining uses of these important pest control products.
Mr. Gillmor. Thank you. Mr. Marquette, you are here today
to provide yet another perspective on FQPA and that is of the
exterminator who relies on products like chlorpyrifos to treat
termites, for instance. But in fact, chlorpyrifos was a product
that became more widely used because of EPA's decision years
back to remove chlordane from the market. Now it seems that the
writing is on the wall for this product as well and you
mentioned synthetic pyrethoids as a substitute. Can you tell me
how these products work differently from chlorpyrifos and
whether they can perform as an adequate substitute should EPA
further restrict uses of the OPs after it completes its
cumulative exposure assessment?
Mr. Marquette. Thank you very much, Mr. Chairman. The loss
of the OPs to the structural pest control industry has been
overwhelming. Two things factor in with the loss of chlordane
and the more use of the chlorpyrifos at that time is that the
OPs, when we are protecting homes against termites and other
wood destroying insects, wood boring--reinfesting, wood boring
insects--those termites will take and--they cause more damage
to homes and business and structural pest control than all the
fires and natural disasters with tornadoes and hurricanes and
everything in the United States and it is a constant year-in,
year-out more damage.
With the OPs, we did have at that time, products that were
able to take and use for long lasting protection. With the
synthetic pyrethroids, it does not seem as we are going to take
and have that long term protection for our customers' homes and
residences.
We have--in essence, the writing has been on the wall for
the OPs for our industry and it has really affected us
tremendously. Fortunately, there is research and we are finding
other products that we may turn to. We are not sure quite how
effective and the efficacy as well as the length of those
products are going to last for our customers to protect their
homes and protect their health. But the synthetic pyrethroids,
the pyrethroids and other products that are available to us
now, we must maintain to continue the health and protection for
the community as a whole. Not only do we protect against the
termites, but we are looking at health risks from mosquitoes,
rodents, everything.
Mr. Gillmor. What do you think you will use in place of
Ficam this year and will it be effective?
Mr. Marquette. It is a toss up right now and I will tell
you what, Ficam for the last 22 years has been an absolute
perfect staple in our arsenal of tools if you want to say. When
we get--I do not feel right now that there is a product out
there that is effective, with assurance that we are going to
get control on stinging insects. We had a child development
center on one of the hospital grounds last year that had 37
different wasp nests on this ground. They had several--I think
it was four different children under the age of 5 that were
stung. We went in, effectively removed those nests without any
jeopardy to the children. To see a child be stung in the way
that they do and the allergic reactions that they have to them,
far outweighs the loss of that product. And honestly, we will
turn to the pyrethroids for control, they do not last as long,
it is a fast acting chemical with a very short residual life.
Mr. Gillmor. Let me, for our last question, go back to Mr.
Zellers and Mr. McClure. One recommendation you make is for
Congress to increase USDA funding to allow it to better
participate in the FQPA process and reassessment. That is an
issue I raised with Dr. Brown as well. In what ways do you
believe U.S. EPA and USDA cooperation may be breaking down or
might be improved?
Mr. Zellers. Mr. Chairman, it is not maybe a matter of
breaking down, but he alluded to some data that is difficult to
arrive or they maybe do not have good data, talking about 12
staff people and I believe $80 million and while that seems on
the periphery a lot of money and 12 staff people, it would be
interesting to know how many people at EPA are working on the
issue. As we feel like USDA--as farmers, they should be our
partner in this, they should be our representative in seeing
that when there is potential loss, that even regionally within
this country, that there is not shifts of production because
one product is lost for use just in that area that might not be
used because of different pests. So I would say, No. 1, it
seemed like USDA from the start was behind the curve on this
and that was more so in the previous administration, and I
think it is just a difficult process to play catch up in and it
seems as if they do have a limited staff and budget to do so
and a limited timeframe. If they are provided data on behalf of
us, it is not adequately occurring.
Mr. McClure. Well, I would just like to reiterate, if you
are low on budget, we want to make sure there is plenty of
testing done. If one of our farms has to quit raising some of
the fruits and vegetables we have here, we cannot store grain
any more because adequate testing was not done before these
chemicals are just done away with, that is not only a big hurt
to us as producers, but actually I think it is damaging to the
consumer, because as we have alluded to many times in our
testimony, then we have to go back to imported goods that do
not always have the same production requirements that we do
here and are allowing the chemicals to be used that we may be
banning. And is that actually helping the consumer? I do not
think so.
If I might, Chairman Gillmor, you know, common sense is
pretty important in life and as we go to this 99.9 percentile
and ten times ten and some of the things I have read about is
maybe eight pounds of grapes a day to a toddler, maybe to my 5
year old, and along at the same time, two quarts of apple juice
and two quarts of grape juice. I might add, that child has got
a lot bigger problems than any chemical residue if they are
eating these volumes to hit the limits that we are talking
about. Common sense has to be used in all things.
Mr. Gillmor. Just as an aside, I do not want to pick on EPA
because they do a great job in a number of ways, but there was
an instance that I recall about 10 years ago where there was an
atrazine limit proposed and I had my staff calculate how much
water you would have to drink to hit that threshold and we
ascertained that if you drank 38 bathtubs full a day for an
extended period of time, you were in serious trouble.
I do want to thank all of the witnesses and I want to thank
USDA and EPA who made a special effort this morning to be here.
We appreciate your input.
And as I mentioned earlier, all of your full statements are
in the record and the record will be held open for 10 days for
anything further that you want to submit.
We thank you very much. Meeting adjourned.
[Whereupon, at 12:13 p.m., the subcommittee was adjourned.]
[Additional material submitted for the record follows:]
PREPARED STATEMENT OF CROPLIFE AMERICA
CropLife America commends this Subcommittee and Chairman Gillmor
for holding this oversight hearing on EPA's implementation of the 1996
Food Quality Protection Act. It is the first such hearing under the
jurisdiction of the Commerce Committee, and much has occurred since the
Act became law almost 6 years ago.
CropLife America is the U.S. industry trade association
representing basic manufacturers, distributors, and formulators of crop
protection and biotechnology products. These companies serve American
agriculture from basic research and development of new products that
protect crops from pests, diseases, and weeds to the manufacture and
marketing of these tools to our farmer customers. Our members include
corporations and cooperatives, both large and small, which operate in a
competitive and changing agricultural world.
We offer these comments jointly with our affiliate association,
RISE (Responsible Industry for a Sound Environment), which represents
our industry's specialty pesticides, largely for urban use. A direct
linkage exists between markets and the regulatory environment for both
agricultural and specialty pesticides. The market synergies of both
sectors support common investment in product discovery, testing, and
development. One company may discover, manufacture, and sell a a
pesticide active ingredient in both markets, thereby spreading
development costs to more products and benefiting customers on both
sides of the equation. Together with RISE, we seek uniform and fair
science-based regulation of all pesticide products.
As this Subcommittee knows, the crop protection industry provides
essential inputs for American farmers that enable them to produce
sufficient food to feed a growing and hungry world. Farmers need a
variety of crop protection tools in order to select the best match for
their individual farming operations and to fit integrated pest
management programs. Their needs can vary widely from year to year,
depending on crops grown, crop rotation schedules, weather, pest
populations, and alternation of products to limit development of pest
resistance.
Preventive use of specialty pesticides prevents human disease
caused by insects and other pests. These EPA-approved products are
necessary to avoid diseases, such as West Nile virus and other types of
encephalitis carried by mosquitos, and serious property damage, such as
caused by termites. Pesticides control a wide variety of pests,
including biting insects, algae, bacteria, infectious microbes, weeds
(such as poison ivy), and termites. Their use is essential to prevent
children and others from risky and potentially life-threatening
exposure to disease-carrying pests and unsanitary conditions. Specialty
pesticides also enhance greenspaces, golf courses, and lawns; keep
rights-of-way clear of burdensome weeds; and help control invasive
species.
Our industry has a long history of government regulation according
to up-to-date, peer-reviewed scientific principles and reliable data
and information. The basic toxicity studies that we conduct on
pesticides are closely parallel those initially conducted on human
drugs. In addition, we evaluate the fate and impact of our products in
the environment, a proven process that is continuously being refined to
better ensure their safe use. When we actively supported repealing the
Delaney provisions in FFDCA in conjunction with passage of FQPA, it was
because we, along with the scientific community, recognized that the
zero risk Delaney standard for carcinogenicity was not based on
accepted scientific principles.
FQPA requires EPA to impose new safety standards for pesticides and
to reevaluate the maximum pesticide residue levels permissible on food.
We support the law's fundamental goals, including enhanced protection
of infants and children. EPA's implementation of FQPA determines the
ultimate fate of many crop protection tools. To avoid unnecessary
disruptions in pest control programs and for reasons of precedent, the
implementation of FQPA must be balanced, reliable, and based on sound
scientific principles.
With passage of FQPA in1996, EPA was required to implement a new
law that was ahead of the science. FQPA did not provide any transition
period for EPA to develop the new science needed to implement the Act.
To meet FQPA's new safety standards, new scientific questions had to be
answered and new data was called for, which created policy and data
gaps. EPA needed a transition period to issue implementing regulations,
develop and issue science policy guidance, gather needed data, and
develop appropriate risk assessment models before making decisions.
As a result, the Agency has been forced to carry out the new law
while developing its plans, policies and new scientific approaches, AND
meeting statutory decision deadlines. EPA is still developing its
scientific approach to cumulative risk assessment, with decisions
expected in early August 2002. Since 1996, despite EPA efforts to the
contrary, implementation has been confusing, inconsistent, and often
arbitrary. The result has been an unpredictable evolving process, with
registrants and users attempting to meet unclear requirements, and
pesticide uses lost unnecessarily.
During the past 6 years, EPA has grown to recognize the importance
of implementing the 4 principles outlined in Vice President Gore's 1998
directive: sound science, transparency, reasonable transition, and
stakeholder involvement. CLA strongly supports these principles as the
foundation for implementing FQPA. In some areas, the Agency has made
steps in the right direction. In other areas, much progress is still
needed.
EPA Actions on August 3, 1999
EPA's actions on August 3, 1999 (the first statutory deadline for
tolerance reassessments) were unacceptable, since the Agency ignored
the Vice-President's commitment to sound science, transparency, orderly
transition, and stakeholder involvement. Although the Administration
proposed and published a clear implementation process, EPA failed to
follow its own plan, abandoning transparency and transition/mitigation
discussions for farmers and other users. The Administration jumped to
decisions without the benefit of public comment on still-evolving
science policies that very likely would have changed the results upon
which EPA based decisions. EPA also refused to review and consider
important data submitted to the Agency in making those decisions.
Shortly before August 3, 1999, EPA top management decided to create
significant ``examples'' of risk mitigation for two organophosphate
(OP) insecticides. This decision was set and the course charted to meet
that goal, notwithstanding the fact that:
a. Not all scientific studies on the two subject chemicals had been
fully evaluated by EPA and incorporated into the risk
assessment.
b. More science studies are in progress.
c. ``Science policies'' that could significantly impact the risk
assessment of the two subject chemicals have yet to be
finalized by EPA.
Under the outright threat of cancellation of these two OPs and the
concern for other products, the registrants were forced to
``negotiate'' and found themselves part of a rush to judgment in order
to contribute to a perception of further achievement by the August 3
deadline. This occurred despite the fact that the Risk Assessment and
Mitigation Phase VI step that was developed by the Tolerance
Reassessment Advisory Committee (TRAC), with full endorsement of USDA
and EPA, would be totally subverted in the process.
Mr. Chairman, while we commend the earnest and hard work of the
companies that ``cooperated'' in negotiating last minute agreements
with EPA to save many uses for these two chemicals, in large part to
help avert a ``food scare'' based on perceptions and threats, the Vice
President's principles suffered a serious blow--and sound science took
a back seat to political science.
We strongly urge this Subcommittee to ensure that EPA not to repeat
the past, and insist that the Agency follow an orderly, open and
predictable process, based on completed defensible science policies and
adequate public participation, in preparation for making its tolerance
reassessment decisions expected this August 3.
SCIENCE POLICIES
EPA has taken steps in the right direction by using a probabilistic
model in aggregate and cumulative risk assessment, and by continuing to
use more refined exposure data in some cases. EPA is increasingly using
more realistic data about actual percentage of crop treated with an
individual pesticide compared to the Agency's earlier FQPA practice of
assuming that 100% of a crop is treated, when that is not the case. EPA
has also made incremental progress on models to estimate pesticide
residues in drinking water. Industry is working jointly with the
federal government to develop modeling procedures that promise
considerable improvement for estimating exposure to pesticides through
drinking water.
However, the impact of the cumulative risk assessment on the
availability of vital pest control uses depends in large part on how
EPA chooses to address key science policy issues which are currently
unresolved.
FQPA Uncertainty Factor
EPA has not yet indicated if they intend to apply the additional
10x uncertainty factor, specified by FQPA, to the overall OP cumulative
risk assessment. The additional FQPA uncertainty factor was intended to
account for potential pre- and post-natal toxicity, and completeness of
data on exposure and toxicity to infants and children. In the case of
the organophosphates, the available data are sufficient to show that
toxicity and exposure to infants and children are adequately understood
in the current risk assessment. Therefore, there is no need for the
additional FQPA uncertainty factor to be applied in the OP cumulative
risk assessment.
If EPA estimates pesticide dietary exposure at the 99.9th
percentile of the population, as it has done in aggregate risk
assessments for individual pesticides, risk mitigation may appear
necessary where it is actually unneeded to provide protection. No other
regulatory agency in the U.S. or elsewhere in the world regulates at
the 99.9th percentile. In many individual chemical assessments, the
choice of even a slightly lower percentiles (e.g. 99.5th) would have
meant no risk mitigation measures would be necessary. The same will
likely be true for the cumulative assessment. While statisticians find
no practical difference between even the 99.9th and 97.5th percentiles,
If EPA regulates at the 99.9th percentile, uses and products could be
lost without additional protection of public health.
According to joint policy of CDC's National Center for Health
Statistics and USDA's Food Surveys Research Group (attached), the
available dietary data used in pesticide risk assessment should not be
used to estimate extreme percentiles of food consumption, as EPA has
done. Based on recommendations of this policy, a minimum sample size of
400 would be needed to reliably estimate the 95th percentile, but at
least 20,000 samples are needed to reliably estimate the 99.9th
percentile. The sample size of USDA's Continuing Survey of Food Intakes
by Individuals (used by EPA to estimate dietary consumption) falls far
short of 20,000.
Use of Clinical Data
EPA has instituted an arbitrary and capricious policy against use
of data from human subjects in its risk assessments under FQPA, under
the guise of a review of the ethics and science of such studies. CLA
vigorously disagrees with this policy and urges that it be rescinded.
It is unethical and immoral for EPA not to consider scientifically
valid human testing that is already completed. To evaluate volunteers
under appropriate scientific guidelines and then disregard valid
scientific data insults the men and women whose valuable time and
effort in these tests were intended to contribute to improving
certainty in estimating pesticide risk and safety. Human testing is
only necessary under limited circumstances, but when it is important,
useful and necessary, it is not reasonable nor lawful for the EPA to
find irrelevant excuses not to use such data.
By ignoring the human testing data, EPA potentially increases the
public's risk. Recent independent scientific analysis of EPA's
reference doses--the dose EPA has determined poses no appreciable risk
to human health--for 38 chemicals, including pesticides, found that in
36 percent of the cases, human data would result in a lower, more
cautious reference dose.
Further, human testing protocol inequities between EPA's pesticide
registrations and FDA's pharmaceutical registrations are unjust and
must be rectified. At least a dozen pesticide molecules are registered
as components of pharmaceuticals--that have gone through extensive
human testing, which is required for FDA drug registration. For
example:
Streptomycin and oxytetracycline, both antibiotics used in
humans, are also pesticides used to treat bacterial diseases of
fruit trees;
Lindane, malathion, and pyrethrin, used in lice shampoos to
treat lice infestations, are also in crop insecticides;
Thiabendazole, used to treat parasitic worms (such as
trichinosis) that afflict humans, is a component of certain
fruit and vegetable fungicides;
Sulfur, used to treat skin diseases, is a widely used
fungicide; and
Warfarin, a blood thinner for treating cardiovascular disease,
is used in rat poisons, which are regulated pesticides.
Pesticides are as beneficial to humans as are pharmaceuticals.
Pesticides help safeguard public health by controlling or eliminating
pests such as cockroaches, associated with asthma; mosquitoes, which
carry West Nile virus, encephalitis, and malaria; ticks, which transmit
Lyme disease; and termites, which destroy houses, barns, and
businesses. Pesticide crop protection prevents losses from damaging
pests, competing weeds, destructive fungi, and devastating plant
diseases. The resulting increases in crop yields and lower production
costs provide us with the benefits of safe, nutritious food that is
abundant and affordable.
Exposure Assessment
Inappropriate Comparisons: In EPA's OP cumulative risk assessment
the Agency is improperly mixing exposure and hazard information.
Standard risk assessment procedures compare acute hazard (toxicology)
data to acute exposure data, and chronic hazard data with chronic
exposure data. In this assessment, EPA is comparing chronic hazard data
with acute exposure data. In order to obtain accurate scientific
results, EPA must compare the chronic hazard data with chronic exposure
data, and acute hazard data with acute exposure data.
Failure to Use Reliable Data
Default Assumptions--Under FQPA, many pesticide uses have been
cancelled unnecessarily due to use of default assumptions in lieu of
real-world data, and in some cases even available data was not used in
decision-making. FQPA expressly requires EPA to use ``reliable''
information, which makes EPA's use of ``default'' assumptions
inappropriate. Although EPA has incorporated registrant-generated data
into its risk assessments, the Agency still uses some default
assumptions rather than available, reliable data. There are also
incidents where EPA is picking and choosing or completely ignoring
reliable data.
For example, EPA's OP cumulative risk assessment over-estimates
residential exposure, relying on several default assumptions. The
result is that the ``risk cup'' is filled unnecessarily, which
threatens unnecessary loss of pesticide uses. In anticipation of the
need for additional real-world data, two industry task forces have been
generating data on residential non-dietary exposure and have kept EPA
informed of their progress. Even so, in some cases EPA has proceeded
with risk assessments without using or waiting for data generated by
the Residential Exposure Joint Venture and the Outdoor Residential
Exposure Task Force. These data should be incorporated into EPA's final
OP cumulative risk assessment to ensure the most accurate estimates of
actual exposure.
Reliable data, not default assumptions, must be used to ensure that
the risk cup is not filled with unsubstantiated ``theoretical risk.''
Where adequate data do not exist, EPA must seek the data.
Cumulative Risk Assessment: Additional Analytical Software Tool
CropLife America has developed the Cumulative and Aggregate Risk
Evaluation System (CARES), an alternative computer software model for
conducting risk assessments under FQPA. CLA urges EPA to use this model
in performing its cumulative risk assessments. Further, EPA should
compare results from CARES to those from Calendex TM,
proprietary software currently used the Agency to conduct the OP
cumulative risk assessment.
The developers of CARES have conducted a cumulative risk assessment
of the OP pesticides, comparable to EPA's preliminary OP cumulative
risk assessment. The CARES software package was submitted to EPA last
week and to members of EPA's Science Advisory Panel (SAP) for review in
April, along with its OP cumulative risk assessment. Recommendations to
EPA regarding EPA's use of CARES are expected from the SAP shortly
thereafter.
CARES provides a number of advantages over the Calendex
TM model currently used by EPA:
It is open and publicly available. (EPA had been criticized
for using a proprietary model in its cumulative risk
assessments, and has acknowledged the need for an open model);
It provides improved and more realistic means of constructing
model populations that take into account seasonal patterns of
exposure.It has the capability of readily identifying the most
likely sources of risk in a cumulative risk assessment. (EPA's
current software used for CRA cannot easily identify ``risk
drivers,'' though EPA says that it is developing a process to
identify them.)
It can run multiple ``what-if'' scenarios, to test the effects
of various risk mitigation scenarios.
EPA has separately funded, in fits and starts, development of the
LifeLine software package, and just recently announced award of a
contract for cumulative risk assessment of the OPs using LifeLine.
However, the enhancements required for LifeLine to accomplish the
cumulative risk assessment are far from complete and will not have been
subjected to peer review by the SAP or elsewhere prior to the August 3
FQPA deadline.
PROCESS ISSUES
Cumulative Risk Assessment (CRA) of the Organophosphates (OPs)
In anticipation of its August 3, 2002 decisions, EPA has indicated
that it plans to follow a broader and more extensive public
participation process than it did before the last FQPA decision
deadline of August 3, 1999. Congress should hold EPA to its word.
EPA plans to issue a revised draft OP cumulative risk assessment
with additional opportunity for public comment, although the June 1
issue date will unduly limit the time for public review and Agency
decision-making.
For this revised CRA to be meaningful given the upcoming August 3
deadline, it must include determinations on: (1) use of the percentile
of exposure as a threshold for regulation (99.9 percentile issue); (2)
use of the FQPA uncertainty factor; 3) use of appropriate toxicity data
for acute and chronic exposure evaluation; (4) identification of any
``risk drivers;'' and (5) if mitigation and transition will be needed.
EPA should convene the CARAT Cumulative Workgroup to discuss the
revised draft CRA and provide input. EPA should establish and inform
stakeholders of its public process to manage the risk cup if it
overflows.
The Agency must be held accountable for announcing its percentile
of regulation, toxicity/exposure comparison, and safety factor policy
decisions as well as identifying risk drivers in its upcoming revised
draft CRA.
Science Policies Should Be Completed Before Decisions Are Made
Final versions of all EPA's science policies that drive FQPA
decisions have been slow in coming, and the last ones are not yet
complete and available to the public. EPA has made FQPA decisions
before finalizing and publishing these critical science policies on
many compounds. Stakeholders, including farmers and other customers,
often have been left guessing what policy approach the Agency will
take, and policies have been inconsistently applied in various Agency
decisions.
Mitigation
EPA's plans and process are unknown regarding any mitigation
measures that may be needed due to the upcoming August 3 decisions. EPA
has informally indicated that the most convenient way may be to drop
uses for specific products rather than spreading use reductions or
eliminations more broadly across products. Lack of a clear process
encourages speculation and deep concern among farmers, other users and
registrants. How will EPA determine benefits? How will the Agency weigh
benefits against risks, and prioritize some benefits over other
benefits? The CARAT Cumulative Workgroup should have the opportunity to
meet to discuss and develop and recommend an orderly plan for
transition and mitigation to the Agency.
Grower Involvement
EPA should involve growers earlier in the FQPA decision-making
process. Currently, growers are contacted during mitigation talks,
after risk assessment has been completed. Growers could have more
meaningful involvement and provide additional reliable information
about actual use and application, for example, if earlier consultation
occurred.
Data Requirements
Congress incorporated into FFDCA provisions from FIFRA that
prescribe how EPA should update and publish the new data requirements
for registering pesticides and how registrants should be given adequate
time to collect the new data on old products and make it available to
the Agency. This process worked very well in updating product databases
for reregistration, as mandated by the FIFRA 1988 amendments. After
FQPA passed, we petitioned and repeatedly urged the Agency to fully
utilize these data updating provisions of the new law. To date, EPA has
shown little indication that the use of these product-specific data-
development provisions is a meaningful part of their implementation
process.
EPA should acknowledge that sound science requires good data and
validated methodologies, which require time to develop. The Agency has
not identified, via formal guidance and rulemaking, which tests
registrants must conduct to generate data for EPA risk assessment
required by FQPA. Testing guidelines, protocols and methodologies
continue to be a moving target. By leaving scientific questions
unanswered, incomplete data can lead to imposition of the FQPA
uncertainty factor and consequent loss of pesticide uses. Registrants
need clear Agency directives to provide specific data in support of
product registrations and tolerances. For example, since registrants
have not had clear guidelines from EPA on how to conduct developmental
neurotoxicity (DNT) tests, some companies have completed the tests,
while others are working with EPA to determine the best methodology to
use. EPA is using DNT data in the OP cumulative risk assessment, but
lack of data from studies still in progress under data call-ins
according to FIFRA procedures should not be used as a basis for loss of
pesticide uses.
EPA should issue updated testing guidelines (40 CFR part 158), as
required under Section 3 (c)(2)(a) of FIFRA to clarify and specify the
kinds of data required to support the registration of a pesticide.
Testing guidelines and data requirements for FQPA's tolerance
reassessment must be clear for fair implementation of FQPA, so the
regulated community and customers understand how to comply with the
Act.
Advisory Committees
Since the enactment of FQPA, stakeholders have advised EPA on
implementation through three successive advisory committees: the Food
Safety Advisory Committee (FSAC), the Tolerance Reassessment Advisory
Committee (TRAC), and the Committee to Advise on Reassessment and
Transition (CARAT). They continue to provide important opportunities
for public understanding and input. This should be continued through
establishment of a permanent Pesticide Advisory Committee, jointly
chaired by USDA and EPA, to advise the agencies on FQPA implementation.
Conclusions
In conclusion, there are improvements needed as EPA implements
FQPA. CLA's summarized concerns on FQPA implementation by EPA are:
EPA has often created policy ``on the fly'' to implement FQPA.
This has involved several major, sudden capricious reversals
and decisions on individual products and on broader policies,
without informing or consulting stakeholders. Instead of giving
ample time to generate new data called for by FQPA, EPA
penalizes pesticides for not having data . . . data EPA hasn't
even required!
EPA's estimates about pesticide exposure have often been
inflated by unsupportable assumptions, judgments, and models
that do not resemble reality. This causes EPA to significantly
overestimate actual risk to farmers and consumers, forcing
unnecessary cancellation of uses and products.
EPA has ignored credible, reliable data about individual
pesticides, and has selectively used questionable data from
studies to help make what is often a political case against
products.
EPA has not yet published current comprehensive data
requirements needed to determine whether a pesticide meets
FQPA's new safety standards. As a result, pesticide companies
must frequently guess which tests to conduct, and these may or
may not satisfy EPA reviewers.
EPA has made pesticide decisions before finalizing and
publishing the science policies upon which the Agency said that
it would base decisions.
Our industry remains committed to Vice President Gore's four
principles, and strongly urges this Subcommittee to ensure that EPA
fully follows them in its implementation of FQPA. It is the only means
by which we can have a fair, consistent, and predictable regulatory
process. And that is essential if we are to maintain today's safe
technologies and have the incentive to discover tomorrow's innovative
new technologies. They will be essential if America is to lead the way
in serving three square meals a day in the coming century to a troubled
and hungry world, enhancing our greenspace, and protecting public
health from disease-causing pests.
______
PREPARED STATEMENT OF THE FQPA IMPLEMENTATION WORKING GROUP
The FQPA Implementation Working Group (IWG) appreciates the
opportunity to present its views to the Subcommittee on Environment and
Hazardous Materials in this oversight hearing on the manner in which
the 1996 Food Quality Protection Act (FQPA) is being implemented by the
U.S. Environmental Protection Agency (EPA) and its Office of Pesticide
Programs (OPP). The IWG is a coalition of farm, food, pest management,
manufacturing, and consumer protection and health benefit industry
organizations that have joined together to address and respond to the
requirements of the FQPA, which amended the Federal Food, Drug, and
Cosmetic Act (FFDCA) and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA).
The FQPA introduced a number of new concepts into the regulation of
pesticides that have required interpretation. The law was enacted in a
rather unusual manner. The House committee bill was approved in a very
short markup session, quickly approved by the House, and approved by
the Senate in a quick floor vote without any committee hearings. The
result of this process was that there is much less legislative history
than is usual for a law of such sweeping importance. It made extremely
important changes in the way EPA was required to make decisions about
the acceptability of pesticide residues on food, but left to EPA the
job of filling in not just the details, but much of the basic concepts.
Moreover, the law became effective upon enactment, and established a
demanding set of deadlines for completion of reassessments of all the
then-existing pesticide residue tolerances. Accordingly, EPA has had to
make policy decisions about how the law should be implemented while it
was also making actual decisions under the law, instead of being able
to first make the policies and then carry them out.
For example, the FQPA requires that in deciding whether the
tolerances for food residues of a particular pesticide were acceptably
safe, EPA must now consider exposure not only to those food residues,
but also to the ``aggregate'' exposure that might result from drinking
water residues or from use of the pesticide in or around residential
areas, to the extent that EPA had ``reliable information'' about such
exposure routes. But Congress did not spell out what the ``reliable
information'' provision actually meant. Data to assess quantitatively
the amount of exposure from residential uses and from drinking water
had never been required before for the overwhelming majority of
pesticides. EPA had to choose whether to (1) include estimated exposure
by these routes in its tolerance reassessments immediately, before the
data could be gathered, knowing that this would require massive
reliance on assumptions, or (2) conduct its initial tolerance
reassessments of exposure by the food route, issue orders to
registrants to gather and submit the needed exposure data, and conduct
a second assessment when the data were received. EPA early took the
position that it would use assumptions and not wait to obtain new data.
And in its early announcements, the Agency indicated that this use of
assumptions about non-food exposure could result in decisions that food
uses of pesticides would have to be eliminated even though the food
uses themselves did not pose unacceptable risk.
A second new consideration introduced by the FQPA is the concept of
cumulative risk from compounds having a common mechanism of toxicity.
While the FQPA merely says that EPA is to consider this potential when
making decisions about the aggregate risk of a particular compound, the
Agency has taken the approach that it must seek to quantify the
cumulative risk in much the same manner as it calculates aggregate risk
for individual compounds.
The third major change in the law was the requirement that when EPA
decides what exposure level is acceptable, EPA should employ an
additional safety factor for the purpose of ensuring the safety of
infants and children unless it can conclude the extra factor is
unneeded. Most of the 10,000 or so tolerances to be reassessed were
initially granted by comparing the food residue levels to an acceptable
value calculated by finding a no-adverse-effect level in animal testing
and dividing it by a safety factor of 100 that is designed to account
for possible inter-species and intra-human sensitivity differences. The
FQPA gives EPA broad discretion and essentially no guidance on how to
decide whether to apply or remove the additional 10X factor.
By late 1997 and into early 1998 it became clear that EPA was
taking positions on these policy/interpretation issues that would lead
the Agency to conclude that exposure was much too high and that many
tolerances would have to be revoked. Moreover, the Agency had not
developed a systematic approach for making its policy decisions openly
after stakeholder discussion. The concerns of growers and other
stakeholders led to demands by Congress and ultimately a directive from
the White House for the creation of a more open FQPA policy-generation
process. This led to the formation of a Tolerance Reassessment Advisory
Committee (TRAC)) co-chaired by high officials of EPA and the
Department of Agriculture, and the discussions by the stakeholder
members of that Committee convinced EPA to publish a series of proposed
``science policy'' documents on various FQPA topics and to take comment
on them.
The FQPA Implementation Working Group was formed in early 1998 to
provide analysis on these policy matters and to make known the
importance of developing policies that are sensible. We submitted to
OPP in June 1998 a set of policy papers collectively titled ``A
Science-Based, Workable Framework for Implementing the Food Quality
Protection Act'' (commonly referred to as the Road Map). It included an
overview section (a copy of which is attached) and a series of detailed
issue papers on the following topics:
``Dietary Exposure;''
``Drinking Water Exposure;''
``Residential Exposure;''
``Aggregate Exposure;''
``Common Mechanism and Cumulative Effects;''
``Choice and Use of Endpoints in Risk Assessments of
Cholinesterase Inhibitors;'' and
``Legal Issues.''
In a number of areas the implementation of the FQPA by EPA has
improved since 1998. The TRAC met from mid-1998 through the end of
1999, even though its environmental and consumer activist members
resigned in protest in April 1999, claiming that it was wrong for EPA
to develop policies before taking action. A second advisory committee,
the Committee on Reassessment and Transition (CARAT) was formed and has
been meeting since mid 2000. We think that these discussions led EPA to
conclude that it is in the Agency's interest to make its process much
more open than it had been, to seek outside opinion on policy choices,
and to seek to make more use of realistic estimates and less use of
worst-case estimates.
Certainly there has been an increased willingness to discuss issues
instead of simply announcing decisions. EPA has made an effort to
explain its approaches and to discuss issues with stakeholders, and has
now issued revised versions of almost all of the 20 or so proposed
science policy papers that were generated by the TRAC process. The IWG
has submitted extensive comments on the proposed documents.
EPA has moved away from several of its most conservative worst-case
assumptions. It also has more data to work with on residential and
drinking water exposure than it did a few years ago. Although it still
lacks the information it needs to make good quantitative estimates of
exposure by those routes, it now is able to make better ``screening''
estimates. For instance, in the cumulative risk assessment now underway
for the organophosphorus (OP) compounds, EPA was able to use modeling
and monitoring information to conclude that there is no potential for
significant OP exposure via drinking water.
However, there still are several areas where OPP is still taking
positions that we think are fundamentally flawed. OPP has finally
provided a response to the IWG argument that before a quantitative
aggregate risk assessment can include exposure via residential or
drinking water routes, the statute expressly requires the Agency to
have ``reliable information'' on the likely levels of exposure via
those routes. OPP now agrees that there must be reliable information,
but says that that does not mean there has to be any information about
exposure levels. OPP says that all it needs to know reliably is that
there probably is some exposure at some level. We think this makes a
mockery of the language and raises the very real possibility that OPP
will use this doctrine to take action against crop uses in order to
protect against completely speculative water residue levels or
residential exposure.
Another area of continuing disagreement is whether the Congress
contemplated that the additional safety factor discussed in the FQPA
can be greater than 10x. We think that a reading of the legislative
history show that the intent was that the factor could be ``up to
10x,'' and EPA's pronouncements at and shortly after enactment
certainly show that was the Agency's understanding then. More recently,
however, EPA has changed its mind and now says the additional factor
may be as large as the Agency desires.
OPP also is in the process of determining how to conduct the
cumulative risk assessment of the important organophosphorus
insecticide category. IWG has very recently filed extensive comments on
OPP's draft assessment (copy attached). While we think several
significant changes in approach are needed, we agree with much of the
assessment and respect OPP's willingness to take comments and issue a
second version, also for comment, before finalizing the assessment. We
emphasized the need to resolve several major policy issues that have
not yet been addressed. For one thing, OPP has not matched exposure
periods with toxicity testing results properly when assessing risk. OPP
is rightly concerned about single-day exposure peaks, but it was
wrongly deriving its toxicity criterion from studies where doses were
given every day over periods ranging from three weeks to two years.
This makes it appear that the overall exposure is too high for some
persons, whereas if the proper comparisons are used the allowable
exposure is increased by a factor of 5 and all the expected exposures
are within the acceptable range. For example, for children age 1-3, in
the highest (99.9th) exposure percentile, the margin of safety goes
from 51 (EPA would say 100 is needed) to about 250, well within the
acceptable zone. What OPP should do is compare single-day human
exposure with the results of single-day toxicity studies, and
separately compare multi-day average human exposure with the results of
multi-day toxicity studies, which is exactly what it has always done in
all other safety assessments it has ever performed.
In addition, we argued that there is no basis for applying an
additional ``FQPA'' safety factor with regard to the cumulative risk of
cholinesterase inhibition posed by the OP compounds. Use of the
standard safety factors (i.e., requiring an MOE of 100) will fully
protect fetuses, infants, and children from any risks of cholinesterase
inhibition from dietary exposure. Any effects that are associated with
high doses used in animal experiments should be given no weight in this
assessment, which should concern itself with the risks, if any, of the
very low doses that would be associated with dietary exposure to OPs.
EPA also should recognize the limitations of using information from
toxicity studies on neonatal and preweanling rats in attempts to
analyze effects in humans because of the differences in developmental
stages between neonatal rats and neonatal humans. There also is no
justification for an additional safety factor with respect to the
completeness of the toxicity database or our understanding of exposure
potential.
Looking beyond the cumulative risk assessment for the OPs, EPA will
face a series of challenging problems as it seeks to meet its second
statutory deadline (it needs to complete its reassessment of the second
third of tolerances by August 2002). After that, the remaining
tolerance reassessments will pose further challenges. The IWG looks
forward to contributing to the discussions that will allow EPA to
develop logical, understandable policies based on sound science.
______
PREPARED STATEMENT OF JANE FORREST REDFERN, ENVIRONMENTAL PROJECTS
DIRECTOR, OHIO CITIZEN ACTION
Congressman Gillmor and members of the committee, I want to thank
you for your invitation to speak today on the Food Quality Protection
Act (FQPA). I am Jane Forrest Redfern, Environmental Projects Director
for Ohio Citizen Action, Ohio's largest environmental citizens
organization.
I worked back in 1995 for the passage of FQPA and I have to say
that with any legislation, there are good things and bad. One thing for
sure is that the sky did not fall when this was being implemented.
Farmers are still farming. Consumers are still buying.
The Act has successfully set up a process to assess pesticides with
the special vulnerabilities of infants and children in mind. I believe
that was the goal--to assess the use and risk of pesticides to the
public, environment, but especially exposure to children.
I want to comment on four areas of FQPA today which are of
particular public health concern:
1. FQPA's implementation has resulted in an orderly process that
removed or severely restricted the most toxic (ten) organophosphate
(OP) insecticides. It has also reigned in the use of a number of cancer
causing fungicides(iporidian ) and several compounds that cause birth
defects, and in general reduced the amount of highly toxic pesticides
released into the environment (from agriculture and residential uses)
with virtually no adverse impact on farmers and zero economic impact on
consumers. FQPA did all this even as it prohibited any consideration of
the economic benefits to farmers in regulatory decision making.
2. We have Pest Management Centers throughout the country looking
at the use and alternatives of pesticides on all of our major crops and
most minor crops. Through funding by USDA, we have studies being
conducted on how farmers use pesticides, when and how much. They are
also looking for pest management alternatives on how to reduce pest
damage and reliance on pesticides. These are good things. If we have an
understanding of pesticide use and alternatives, we can help and assist
farmers on how to become more efficient, save money and reduce risk to
themselves, their children, the public and the environment.
3. I see other actions and studies done by other entities right
here in Ohio, due to FQPA: The Ohio EPA did a comprehensive study of
water utilities and the levels of pesticides in drinking water.
This study then led to Ohio EPA requiring some of those drinking
water suppliers with high levels of pesticides in their water to do
additional testing of known pesticides more regularly. That led many
water suppliers to look at their water systems and ways to reduce
pesticides. For example: The City of Columbus worked with the Farm
Bureau, Novartis and farmers to reduce or eliminate atrazine use in the
Big Walnut Watershed, this has led to an overall reduction of use of
powdered carbon to treat the drinking water.
The City of Bowling Green added a $2.3 million dollar water
treatment plant due to high levels of pesticides in their drinking
water supplies. The State of Ohio has had to look at pesticide use in
Ohio and do planning and assessment of the pesticide use in Ohio.
Lastly, I support the implementation of the FQPA, but in some
cases, the implementation is not as comprehensive, moving fast enough
or meeting the legal requirements set out in the Act. The USEPA needs
to do the following things to continue the implementation and to comply
with FQPA fully: USEPA needs to add in a safety factor of at least ten
in their calculations of risks for children and take into account the
differences of diet, size, eating patterns and health status of the
variable US population.
Children from rural communities and of farm workers are at higher
exposure risk to agriculture use of pesticides, and need special
consideration and deserve protection under the FQPA (1-9). There is
evidence in the published literature that farmworkers, and people
living in farm communities, are at greater risk for certain kinds of
cancer because of their exposure to pesticides (10-18) The Act requires
protection of all children, even our own rural children.
USEPA needs to look at ranges for risk calculations instead of
averages. The EPA must consider the fetuses, infants, and children
exposed to maximum pesticide use rates, maximum pesticide food
residues, and maximum water contaminant levels, because real children
are exposed to these elevated levels in the real world. All children
must be protected under FQPA.
In implementing FQPA, the USEPA needs to review all data submitted
for the review, including published data, and not just data submitted
by the chemical manufacturers, to make decisions that are protective
and proved to be sufficient. If there is no data, USEPA needs to use
the safety factor to be most protective as required by the Act.
The concerns raised in these short comments are only a small list
of the considerations which are mandated by FQPA, and which are
necessary to adequately protect the environmental and public health of
American communities and therefore, I respectively submit comments for
the record from: Children's Environmental Health Network; Consumers
Union; Institute for Environment and Agriculture; World Wildlife Fund
and Natural Resources Defense Council
Thank you for your time and consideration of my comments this
morning, on a matter of protection of our health, the health of our
families, and our environment.
References
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families. Occup Med 12:221-37.(1997).
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