[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

                               __________

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                            WASHINGTON : 2002
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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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Biological monitoring of organophosphorus pesticide exposure among 
children of agricultural workers in central Washington State. Environ 
Health Perspect 105:1344-53.(1997).
    2. Fenske RA. Pesticide exposure assessment of workers and their 
families. Occup Med 12:221-37.(1997).
    3. Fenske RA, Kissel JC, Lu C, Kalman DA, Simcox NJ, Allen EH, 
Keifer MC. Biologically based pesticide dose estimates for children in 
an agricultural community. Environ Health Perspect 108:515-20. (2000).
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