Attachment B: Accomplishments under the Food Quality Protection Act

Accomplishments under the Food Quality Protection Act (FQPA) | Pesticides | US EPA

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Accomplishments under the Food Quality Protection Act
(FQPA)
August 3, 2006 -- 10th Anniversary of the Food Quality Protection Act

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Overview
With the 1996 enactment of the Food Quality Protection Act
(FQPA), Congress presented EPA with the enormous challenge of
implementing the most comprehensive and historic overhaul of the

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FQPA
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Pesticide-Producing
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Nation's pesticide and food safety laws in decades. The
centerpiece of FQPA was the requirement to complete within a

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Laws and Regulations

decade the massive review and reassessment of the tolerances

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International Activities

(maximum permitted residues) for all food use pesticides. On the

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Adverse Effects
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Tolerance Reassessment
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tenth anniversary of FQPA enactment, we have completed over
99% of the required tolerance reassessments, and we celebrate the cumulative public health progress
achieved by the thousands of individual protective actions taken under this law. This degree of success
for such an ambitious, controversial and complex undertaking is unprecedented.
When it passed, House Commerce Committee Chairman Bliley noted the bill was a "landmark bipartisan
agreement that will bring Federal regulation of the Nation's food producers into the 21st century."
Recognizing the formidable charge Congress was placing on the Agency, Agriculture Committee Chairman
Roberts stated that "the ultimate success of this reform will rest with the professionalism and the
common sense of EPA."
Over this 10-year period, EPA and its public and private sector partners have met FQPA's challenge and
achieved significant enhancements in public health and environmental protection for the American
people. This tremendous accomplishment required persistence and commitment to the strategic FQPA
principles of sound, science-based decisions, open government, timely action, and sensible public policy.
By successfully implementing the Food Quality Protection Act, EPA is ensuring that all pesticides used on
food in the United States meet FQPA's more stringent safety standard. To carry out the pesticide
regulatory program under FQPA, EPA has used groundbreaking science and provided extensive
opportunities for public involvement, while maintaining a commitment to timeliness. As a result, the
Agency and its partners have upgraded the protective framework of integrated programs and actions
ensuring that safe and effective pesticides are available to support production of one of the most
abundant, affordable, and healthy food supplies in the world and to safely meet America's other pest
control needs.
On this page:

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Overview
Notable Achievements
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Expanded Scope of Protection
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Timely Reassessments
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Advancing Science
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Opening up the Process
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Establishing Partnerships
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Meeting Needs for Safe, Effective Pest Control Products
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Addressing Major Policy Changes
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Providing Tailored Attention to Unique Classes of Pesticides
Conclusion

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Notable Achievements
Expanded Scope of Protection

FQPA dramatically changed the safety standards EPA uses in evaluating potential pesticide
risks, especially to infants and children. Since FQPA was enacted, effective protection of
children, already a priority, received additional emphasis through the addition of an extra
tenfold Children's Safety Factor. This additional factor is now standard in dietary risk
assessments, unless reliable data support a different factor.
Other new protective measures require EPA to assess the aggregate impact of exposure to
pesticides in the food we eat and water we drink, along with exposures resulting from
residential pesticide uses and other non-occupational sources of exposure. Finally, FQPA
mandated that EPA's safety assessments consider the cumulative effects on health from
exposures to multiple different pesticides that cause the same biological effects in
humans.

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Timely Reassessments Despite Massive Number of Actions

The 1996 FQPA required EPA to reassess the safety of thousands of existing tolerances
and tolerance exemptions by August 3, 2006, while simultaneously making determinations
about the reregistration of existing pesticides and reviewing the registrations of thousands
of pesticide end-use products. EPA has succeeded in meeting these goals beyond all
reasonable expectations.
FQPA required the Agency to complete 33 percent of the required tolerance reassessment
decisions within three years, 66 percent within six years, and 100 percent within 10 years,
giving priority to the review of pesticides that pose the greatest risk to public health. EPA
readily met the first two statutory deadlines, and has completed nearly all the remaining
tolerance reassessment decisions within the 10-year timeframe. This tolerance
reassessment effort has led, among other things, to EPA decisions to revoke or modify
thousands of existing tolerances, and to require the establishment of many new
tolerances, improving food safety and human health protection in the U.S.

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The reregistration program, while not a formal part of FQPA, is the critical mechanism
used by EPA to implement its provisions. FQPA presented new challenges that
strengthened our existing reregistration program. Thus, EPA made it our goal to complete
reregistration of all the food use pesticides as we completed their tolerance reassessment.
Reregistering food use pesticides meant not only that EPA reassessed their tolerances but
also that EPA evaluated the safety of those pesticides for workers and the environment.
This effort entailed review of tens of thousands of new studies – a significant amount of
additional work to accomplish in 10 years. EPA has completed nearly all of this work:

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Completed 9,637, or over 99% of the 9,721 tolerance reassessment decisions
required by FQPA, please see figure 1
Recommended the revocation of 3,200 tolerances
Recommended the modification of 1,200 tolerances
Confirmed the safety of 5,237 tolerances

Figure 1

The Food Quality Protection Act of 1996 required EPA to review the safety of all existing tolerances that
were in effect as of August 1996. Of the 9,721 existing tolerances, EPA was requred to reassess 33% by
August 3, 1999, 66% by August 3, 2002, and 100% by August 3, 2006.

In completing these tolerance reassessment decisions, the Agency also has completed:

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Reregistration actions or eligibility decisions for 559, or almost 99 percent of the
566 reregistration eligibility decisions due by August 3, 2006.
These actions include the cancellation of nearly 4,400 individual pesticide enduse product registrations out of a current universe of 17,592.
EPA plans to complete reregistration eligibility decisions for the remaining 47 nonfood use pesticide reregistration cases by October 3, 2008, as required by the

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2004 amendments to FIFRA contained in the Pesticide Registration Improvement
Act (PRIA).

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Advancing Science

Implementation of FQPA required the development of more refined pesticide risk
assessments that better reflect real-world situations and that provide an adequate margin
of safety for children and infants. To meet this challenge, EPA worked diligently to
enhance and develop innovative risk assessment tools and methods for identifying those
chemicals that have the greatest potential to harm human health and the environment.
Aggregate Exposure and Risk Assessment
One critical risk assessment advancement was the development of aggregate exposure
and risk assessment methods that account for exposure to a pesticide by multiple routes
and from multiple sources, including food, drinking water, residential, and other nonoccupational sources. In developing aggregate risk assessment methods, EPA developed
and refined complex models that evaluate multiple exposures from each source via oral,
dermal, and inhalation routes.
Each model is highly specific to the source and considers almost all possible scenarios of
exposure. For instance, EPA has models for up to 30 different residential pesticide
exposure scenarios, covering uses ranging from lawn and garden care and household
insect control, to exposures to humans due to pet treatments and wearing clothes
impregnated with insect repellents. Accurately assessing the complex pesticide risks from
all these varied use patterns required the creation of new "aggregate exposure" models
capable of combining exposures received by an individual from food, water, and
residential uses, through oral, dermal, or inhalation routes. These cutting edge scientific
models now provide more accurate assessments of the risks of using pesticides, ensuring
better informed and protective Agency decisions.
Cumulative Exposure Risk Assessment
In addition to the aggregate risk assessment tools, EPA has also developed tools for
performing cumulative risk assessment, in which groups of pesticides that share a
common mechanism of toxicity are evaluated together. This approach combines the
estimates of aggregate exposure for individual chemicals with the same toxic effect and
generates a cumulative risk assessment. EPA has conducted these extraordinarily intricate
assessments for four pesticide groups:

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Organophosphate insecticides
Carbamate insecticides
Triazine herbicides
Chloracetanilide herbicides

Developing models and algorithms to calculate these assessments required persistence,
motivation, and cooperation from all science disciplines as well as input from outside
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experts.
To evaluate the 870 tolerance exemptions for pesticide inert ingredients that were part of
the FQPA reassessment effort, the Office of Pesticide Programs (OPP) used available inhouse data and existing publicly available assessments conducted by other U.S. Federal
agencies such as the Agency for Toxic Substances and Disease Registry, National
Toxicology Program, and international organizations such as the Organization for
Economic Cooperation and Development and World Health Organization. A wealth of data
and information exists on many of these chemicals because the majority of their uses are
in industrial processes and the manufacture of consumer goods. OPP also consulted with
experts in EPA's Office of Pollution Prevention and Toxics on Structure Activity
Relationships (SAR) to ensure the proper use of available data on similar chemicals. Also,
OPP developed models to assist in the characterization of risk from the use of inert
ingredients on food commodities.
Coordination and Advice
OPP worked closely with other government agencies and other EPA program offices in
developing new scientific approaches. The program's work with the Office of Research and
Development to obtain data, develop policies, and formulate models and with the Office of
Water on water modeling are just two examples.
OPP typically seeks the advice of the FIFRA Scientific Advisory Panel (SAP) whenever it
encounters complex or novel scientific issues. The increase in the number of SAP
consultations since FQPA demonstrates the large number of complex scientific issues
tackled by the Agency. In the last 10 years, EPA has consulted the SAP 58 times.

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Opening up the Process

To help implement FQPA, EPA created a transparent, collaborative process through which
the public could participate directly and regularly, and EPA could obtain valuable input and
information. Before FQPA, opportunities for the public to be actively involved in the
development of regulatory decisions on pesticides were limited. EPA recognized that public
participation and open discussion, at all stages of the process, enhances everyone's
understanding of both science and policy issues and provides a sound basis for risk
management decisions.
Advisory Committees One way EPA has ensured stakeholder consultation and public
involvement was by creating a number of federal advisory committees. These committees
include:

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The Food Safety Advisory Committee
The Tolerance Reassessment Advisory Committee (TRAC)
The Committee to Advise on Reassessment and Transition (CARAT)

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The Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC)

Public Participation Process EPA, following the recommendations of TRAC, one of its
advisory committees, established a formal public participation process. This process was
first piloted for the organophosphate pesticides starting in 1998, and it was soon extended
to all pesticides undergoing reregistration and tolerance reassessment. Since then, public
input has helped shape the outcome of reregistration and tolerance reassessment
decisions. Input from the public has also helped illuminate and refine pesticide risks,
leading to more effective regulatory decisions and better health protection.
Pesticide Web site Further enhancing transparency of public process is the role the
Internet has played in FQPA implementation. EPA's pesticides topic area Web site with its
substantive pesticide topic area offers the public ready access to information on regulatory
decisions, risk assessments, advisory committees, and a host of other subjects and issue
areas. The American public now expects this kind of service from the government, and
uses the Internet more than ever before. According to a Pew Foundation poll, for example,
more than 40 million people went on-line to look at federal, state and local government
policies, and over 20 million used the Internet to send their views to governments about
those policies. During the FQPA implementation period, the public has grown to rely on the
internet as a major channel of communication and an information resource. EPA has used
this technology to its fullest to provide services and information that is centered on its
stakeholders.

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Establishing Partnerships with All Stakeholders

FQPA created momentum for fuller participation by all stakeholders. EPA's accomplishment
in meeting the goals and mandates of FQPA is based on strong partnerships with other
federal agencies, international organizations, states, tribes, and many other stakeholders.
As with any major change in the law and the regulatory process, numerous constituencies
became concerned about how the new law would be implemented. There had been broad
consensus supporting the strengthened protection of the public that Congress mandated in
FQPA, but there were also corresponding concerns about potential impacts on those whose
livelihood and practices would potentially be affected as EPA implemented the law.
Registrants and User Groups Addressing FQPA's mandates has been an informationintensive exercise for all parties. Pesticide registrants have conducted tens of thousands of
new scientific studies on pesticides, and user groups have provided an enormous amount
of information needed to better characterize the real-world use of pesticide products.
Regulation of antimicrobial pesticides engages a diverse and often unique group of
stakeholders, including consumer product companies, infection control specialists, public
health agencies at the federal, state, and local levels, and professional and other interest
groups. EPA has a staff dedicated to antimicrobial issues and has taken several steps to

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develop strong relationships with this distinct group of stakeholders. The Agency currently
enjoys several constructive partnerships in the antimicrobial arena.
Federal Agencies From the outset, the U.S. Department of Agriculture (USDA) has also
provided critical data through food consumption surveys and the Pesticide Data Program,
which help refine risk estimates. The Agency has worked with USDA to characterize the
benefits of pesticide use on specific crop-pesticide combinations where limited crop
protection alternatives exist.
FQPA has caused many changes in the way pesticides are used. In some cases, rather
than develop new data to address questions about safety, registrants voluntarily withdrew
tolerances and registrations for crop uses. This, in turn, spurred companies to develop and
growers to pursue reduced-risk alternatives. EPA and several partner agencies that
coordinate regulatory actions at the national level have assisted in these transitions.
USDA, in particular, has been an important partner in developing and evaluating
alternative pest control tools and reaching out to the agricultural community and ensuring
that their concerns are addressed. USDA's Office of Pest Management Policy:

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Serves as a liaison to EPA and the agricultural community
Supports minor use registrations through the Inter-Regional Research Project
No. 4
Conducts training for pesticide applicators through its cooperative extension
service

The Department of Health and Human Services (HHS) and EPA together have advanced
efforts to achieve mutual environmental public health goals and strengthened the bridge
between the environmental and public health communities, with a special emphasis on
public health use pesticides. The outcome has been a better understanding of the linkages
between environmental hazards, ensuing human exposure, and potential health outcomes
that better inform environmental and public health decisions and improve our ability to
assess the efficacy of such policies and decisions. Examples of consultative activities
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Sharing the science of mosquito and other vector control with the Centers for
Disease Control and Prevention
Assisting the Food and Drug Administration to improve detection of pesticide
residues in food at far lower levels than previously possible

International Partners FQPA also set the stage for major changes in our collaboration
with other countries in pesticide evaluation and control. Some countries, such as Canada,
have adopted similar standards through domestic regulation. EPA has also worked on a
range of pesticide issues with regulators in Europe, Japan, and other countries in the
Organization for Economic Cooperation and Development, as well as with international
organizations such as the Food and Agriculture Organization (FAO)
World Health Organization (WHO)

, and Codex

, the
. This

cooperation has helped to improve food safety and environmental protection and is an
integral factor in resolving trade problems and streamlining regulatory processes.
Public interest advocacy groups are also important stakeholders with a strong interest

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in our implementation of FQPA. They have provided valuable input to strengthen the risk
assessment and risk management process.
The states and tribes are very much our regulatory partners and have an essential role
in FQPA implementation through their delegated authority to enforce pesticide regulations
within their jurisdiction. As the people "on the ground," state and tribal regulators interact
directly with pesticide dealers and commercial applicators, as well with farmers and others
who use pesticide products. Their unique position helps us collect information on pest
control needs, current pesticide use practices, and the potential impacts of changes in
pesticide availability that may result from FQPA-based decisions. State and tribal agencies
also have the role of communicating regulatory decisions to the user community and in
providing information and training in the use of alternative pest control methods to
replace products that may not meet FQPA safety standards.
Advisory Committees and Workgroups Throughout implementation, EPA sought to
bring key FQPA policy and implementation issues to a broad coalition of stakeholders. As
noted previously, EPA established or used several federal advisory committees since
passage of FQPA to ensure an open and transparent decision-making process. Membership
to these advisory committees and work groups included a broad representation of
stakeholders, including pesticide companies, environmental/public interest groups,
pesticide users and growers, farmworker representatives, public health officials, academia,
Federal representatives, state officials, and tribal government representatives.

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The Food Safety Advisory Committee (FSAC) was established immediately after
FQPA passage (through December 1996); it developed interim decision policies,
which are still being employed.
The Tolerance Reassessment Advisory Committee (TRAC) followed FSAC and
gave useful advice on the development and communication of critical science
policies that EPA used in its FQPA risk assessments, and has piloted the public
participation process used in reregistration.
The Agency created the Committee to Advise on Reassessment and Transition
(CARAT) as follow-on to TRAC's efforts, with a particular focus on strategic
approaches for pest management planning and tolerance reassessment.

In addition to these specific FQPA advisory committees, the following committees and
organizations also addressed FQPA issues:

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The Pesticide Program Dialogue Committee, a permanent, broadly representative advisory
committee, meets with EPA on a regular basis to discuss issues associated with FQPA
implementation.
EPA involved its FIFRA Scientific Advisory Panel of independent scientists in developing
approaches for implementing many of the more technically challenging FQPA scientific
assessment policies.
The Endocrine Screening and Testing Advisory Committee (EDSTAC) and the Endocrine
Disruptor Methods Validation Advisory Committee (EDMVAC) are two advisory committees of
scientists and stakeholders that have offered guidance on the development and implementation
of the Endocrine Disruptor Program mandated by FQPA.
The State FIFRA Issues Research and Evaluation Group (SFIREG), which consists primarily of
state pesticide regulatory officials, continues to work with EPA to improve the development,
guidance, and approval of state pesticide programs and policies.
The Tribal Pesticide Program Council (TPPC) brings together regulatory officials responsible for
tribal pesticide programs, and offer useful perspectives on how EPA and tribes can work more
effectively. Advice from TPPC has led to the creation of new risk assessment models that
capture differences in pesticide risk for tribal members.

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Meeting Agriculture's Need for Safe, Effective Pest Control Products

FQPA acknowledges the importance of "reduced-risk pesticides" and supports expedited
review to help these pesticides reach the market sooner and replace older and potentially
riskier chemicals. The law defines a reduced risk pesticide as one which may reasonably
be expected to accomplish one or more of the following:

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Reduce pesticide risks to human health
Reduce pesticide risks to non-target organisms
Reduce the potential for contamination of valued, environmental resources
Broaden adoption of IPM or make it more effective

EPA developed procedures and guidelines on expedited review of applications for
registration or amendments for a reduced risk pesticide. The Agency expanded the
pesticide program to include consideration of new active ingredients, new uses of active
ingredients already deemed to be reduced risk, and amendments to all uses deemed to be
reduced risk. EPA gives priority of review to reduced risk pesticides and worked with the
regulated community and user groups to refine review and registration procedures.
Minor uses of pesticides are defined as uses for which pesticide product sales are low
enough to make it difficult for a manufacturer to justify the costs of developing and
maintaining EPA registrations. Collectively, such "minor" crops are important to a healthy
diet, and include many fruits and vegetables. Minor uses also include use on commercially
grown flowers, trees and shrubs, certain applications to major crops such as wheat or corn
where the pest problem is not widespread, and many public health applications. Since
many of these uses produce smaller revenues for pesticide registrants than do major
uses, the registrants are sometimes reluctant to support and maintain registrations and
associated tolerances. Some minor uses have been lost through lack of registrant support
during the reregistration process, resulting in grower concerns that adequate pest control
tools will no longer be available for many minor crops.
Registration of minor uses of pesticides is a priority for the Agency, and both USDA and
EPA have worked to alleviate minor use problems. EPA has a staff dedicated to minor use
registrations and the Agency works closely with USDA's IR-4 program

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generate residue data for tolerances on minor crops. Data requirements to support minor
uses are carefully considered to minimize the burden of data generation. EPA and USDA
operate early alert systems to notify growers when a pesticide use for a minor crop is
about to be canceled. EPA also provides advance public notice of a proposed cancellation
to allow time for another registrant to consider maintaining the pesticide use.

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Addressing Major Public Policy Challenges

Effective FQPA implementation required not only new cutting-edge science policies and

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operational procedures, but also the resolution of significant public policy issues. Notably,
concern about the potential use of data obtained from human studies was a barrier to
taking final protective action for a number of pesticides. Over a period of years, the
Agency evaluated the competing considerations and sought public input and expert advice
on the ethical and scientific issues associated with human testing from its own advisory
committees and the National Academy of Sciences. This put EPA in the position to act
swiftly to meet a 2005 Congressional directive to establish a final Human Studies
regulation before it could review or rely on data from human research in tolerance
reassessment. In a matter of months, the Agency developed regulations to strengthen and
expand significantly the protections for subjects of human research. These regulations:

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Prohibit new research for pesticides involving intentional exposure of children
and pregnant and nursing women
Extend ethical protections in the Common Rule to other human research
involving intentional exposure of non-pregnant, non-nursing adults
Require submission to EPA of protocols and related information to ensure any
future studies meet the highest ethical safeguards
Require the establishment of an independent Human Studies Review Board
(HSRB) to obtain expert peer review of both proposals for new research and
completed third-party intentional dosing

EPA established the independent Human Studies Review Board (HSRB), which is made up
of world class scientists, and will take into serious consideration the scientific and ethical
advice and recommendations of HSRB concerning use of human research data in our
pesticide risk assessments.

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Providing Tailored Attention to Unique Classes of Pesticides

Antimicrobials and biopesticides present different and special challenges from the typical
agricultural pesticide. In recognition of these differences FQPA directed EPA to regulate
these products in a manner consistent with their unique characteristics. Although not
formally required by FQPA, EPA undertook a major organizational overhaul to deal with
these challenges. The new structure dedicated separate divisions to the regulation of
antimicrobials and biopesticides. The creation of the Antimicrobials Division and the
Biopesticides and Pollution Prevention Division ensured that these unique materials would
be evaluated by highly educated specialists who would make sure that these products
receive timely and appropriate scientific and regulatory reviews.

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Conclusion
A Bright Future – After a decade of groundbreaking accomplishments, FQPA provisions,
principles, and innovative scientific approaches have become an integral part of the
Agency's work. This bedrock foundation will sustain effective pesticide regulation and
helps ensure that the American people will continue to enjoy one of the most plentiful,
wholesome, and reliable food supplies in the world. With the tools of FQPA, the national

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pesticide program is equipped to meet the challenges of protecting public health and the
environment for decades to come.

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