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# Accomplishments under the Food Quality Protection Act (FQPA)

August 3, 2006 -- 10th Anniversar y of the Food Quality Protection Act



### 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 Nation's pesticide and food safety laws in decades. The centerpiece of FQPA was the requirement to complete within a decade the massive review and reassessment of the tolerances (maximum permitted residues) for all food use pesticides. On the 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 ambiti ous, controversial and complex undertaking is unprecedented.

When it passed, House Commerce Committee Ch airman Bliley noted the bill was a "landmark bipartisan agreement that will bring Federal regu lation of the Nation's food producers into the 21st century." Recognizing the formidable ch arge 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 enhancem ents in public health and environmental protection for the American people. This trem endous 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 Ag ency and its partners have upgraded the protective framework of integrated programs and actions ensuring th at safe and effective pesticides are available to support production of one of the most ab undant, affordable, and healthy food supplies in the world and to safely meet America's other pest control needs.

On this page: Quick Resources

FQPA
FQPA Home FQPA Background Accomplishments under FQPA Implementation of Requirements under FQPA
Related Pesticides Resources
Tolerance Reassessment Endocrine Disruptors Science Policies 

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_ accom p lishments.htmOverview Notable Achievements Expanded Scope of Protection Timely Reassessments Advancing Science Opening up the Process Establishing Partnerships Meeting Needs for Safe, Effe ctive Pest Control Products Addressing Major Policy Changes Providing Tailored Attention to Unique Classes of Pesticides Conclusion



### Notable Achievements

Expanded Scope of Protection

FQPA dramatically changed the safety stan dards 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 pest icide uses and other non-occupational sources of exposure. Finally, FQPA mand ated 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.

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 beyo nd 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 read ily met the first two statutory deadlines, and has completed nearly all the remaining tolerance reassessment decisions within the 10-year timeframe. This tolera nce reassessment effort has led, among other things, to EPA decisions to revo ke or modify thousands of existing tolerances, and to require the establishm ent of many new tolerances, improving food safety and human health protection in the U.S.

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 existi ng reregistration program. Thus, EPA made it our goal to complete reregistrati on of all the food use pesticides as we completed their tolerance reassessment. Re registering food use pesticides meant not only that EPA reassessed their tole rances but also that EPA evaluated the 

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_ accom p lishments.htmsafety of those pesticides for workers an d the environment. Th is effort entailed review of tens of thousands of new stud ies – a significant amount of additional work to accomplish in 10 years. EPA ha s completed nearly all of this work:

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 August1996. 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 reassessm ent decisions, the Agency also has completed:

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 end-use product registrations out of a current universe of 17,592. EPA plans to complete reregistration eligibility decisions for the remaining 47 non-food use pesticide reregistration cases by October 3, 2008, as required by the 2004 amendments to FIFRA contained in the Pesticide Re g istration Im p rovement Act ( PRIA )

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_ accom p lishments.htmAdvancing Science

Implementation of FQPA required the de velopment of more refined pesticide risk assessments that better reflect real-world situations and that provide an adequate margin of safety for children an d 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 advancem ent was the development of aggregate exposure and risk assessment methods thataccount for exposure to a pesticide by multiple routes and from multiple so urces, including food, drinking water, residential, and other non-occupational sources. In developing aggregate risk assessment methods, EPA developed and refined complex models that evaluate multiple exposures from each source vi a oral, dermal, and inhalation routes.

Each model is highly specific to the source and considers almost all possible scenarios of exposure. For instance, EP A has models for up to 30 different residential pesticide exposure scenarios, covering uses ranging from lawn and garden care and household insect contro l, to exposures to humans due to pet treatments and wearing clothes impregnate d with insect repellents. Accurately assessing the complex pesticide risks from all these varied use patterns required the creation of new "aggregate expo sure" models capable of combining exposures received by an individual fr om food, water, and residential uses, through oral, dermal, or inhalation rout es. 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 assess ment tools, EPA has also developed tools for performing cumulative risk assessment , in which groups of pesticides that share a common mechanism of toxicity ar e evaluated together. This approach combines the estimate s of aggregate exposure for individual chemicals with the same toxic effect and generates a cu mulative risk assessment. EPA has conducted these extraordinarily intricate assessments for four pesticide groups:

Organophosphate insecticides Carbamate insecticides Triazine herbicides Chloracetanilide herbicides

Developing models and al gorithms to calculate th ese assessments required persistence, motivation, and cooperation from all science disciplines as well as input from outside experts.

To evaluate the 870 tolerance exemptions for pesticide inert ingredients that were part of the FQPA reassessment ef fort, the Office of Pesticide Programs (OPP) used available in-house data and existing publicly available assessments conducted by other U.S. Federal agencies such as the Agency for Toxic 

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_ accom p lishments.htmSubstances and Disease Registry, National Toxicology Program, and international organizations such as the Organization for Economic Cooperation and Development and World Health Organizati on. A wealth of data and information exists on many of these chemicals beca use the majority of their uses are in industrial processes and th e manufacture of consumer goods. OPP also consulted with experts in EPA's Office of Polluti on 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 a pproaches. 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 mode ling are just two examples.

OPP typically seeks the advice of th e 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.

Opening up the Process

To help implement FQPA, EPA created a transparent, collaborative process through which the public could participat e directly and regularly, and EPA could obtain valuable input and information. Be fore FQPA, opportunities for the public to be actively involved in the developmen t of regulatory decisions on pesticides were limited. EPA recognized that public participation and open discussion, at all stages of the process, enhances everyo ne's understanding of both science and policy issues and provides a sound ba sis for risk management decisions.

Advisory Committees One way EPA has ensured st akeholder consultation and public involvement was by creating a nu mber of federal advisory committees. These committees include:

The Food Safety Advisory Committee The Tolerance Reassessment Advisory Committee (TRAC) The Committee to Advise on Reassessment and Transition (CARAT) The Endocrine Disruptors Screening and Testing Advisory Committee (EDSTAC)

Public Participation Process EPA, following the reco mmendations of TRAC, one of its advisory committees, established a formal public participation process . This process was first piloted for the organoph osphate pesticides starting in 1998, and it was soon extended to all pesticides undergoing reregistration and tolerance reassessment. Since then, public inpu t has helped shape the outcome of reregistration and tolerance reassessment decisions. Input from the public has also helped illuminate and refine pestic ide risks, leading to more effective regulatory decisions and be tter health protection. 

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_ accom p lishments.htmPesticide 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 ar ea offers the public ready access to information on regulatory decisions, ri sk assessments, advisory committees, and a host of other subjects and issue area s. The American public now expects this kind of service from the government, an d uses the Internet more than ever before. According to a Pew Foundation po ll, 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 commu nication and an information resource. EPA has used this technology to its full est to provide services and information that is centered on its stakeholders.

Establishing Partnerships with All Stakeholders

FQPA created momentum for fuller part icipation 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 information-intensive exercise for all parties. Pesticide registrants have conducted tens of thousands of new scie ntific 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 othe r interest groups. EPA has a staff dedicated to antimicrobial issues and has taken several steps to de velop 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. Depa rtment 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 pr otection alternatives exist.

FQPA has caused many changes in the way pesticides are used. In some cases, rather than develop new data to addr ess questions about safety, registrants voluntarily withdrew tolerances and regi strations for crop uses. This, in turn, spurred companies to develop and growers to pursue reduced-risk alternatives. 

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_ accom p lishments.htmEPA 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 evalua ting alternative pest control tools and reaching out to the agricultural communit y and ensuring that their concerns are addressed. USDA's Office of Pest Management Policy :
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 Se rvices (HHS) and EPA together have advanced efforts to achieve mutual en vironmental public health goals and strengthened the bridge between th e 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 po tential health outcomes that better inform environmental and public health decisions and improve our ability to assess the efficacy of such policies an d decisions. Examples of consultative activities include:

Sharing the science of mosquito and ot her 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 lowe r 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) , the World Health Organization (WHO) , and Codex . This cooperation has helped to improve food safety and envi ronmental protection and is an integral factor in resolving trade problems and stre amlining regulatory processes.

Public interest advocacy groups are also important stakeholders with a strong interest 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 thei r jurisdiction. As the people "on the ground," state and tribal regulators inte ract 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 po tential impacts of changes in pesticide availability that may result from FQPA-bas ed decisions. State and tribal agencies also have the role of communicating regu latory 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. 

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_ accom p lishments.htmAdvisory Committees and Workgroups Throughout implementation, EPA sought to bring key FQPA policy and implem entation issues to a broad coalition of stakeholders. As noted previously, EPA established or used several federal advisory committees since passage of FQ PA 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.
The Food Safety Advisory Committee (FSAC) was established immediately after FQPA passage (through Dece mber 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 develo pment 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 advi sory committees, the following committees and organizations also addressed FQPA issues:

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 ma ny of the more technically challenging FQPA scientific assessment policies.

The Endocrine Screening and Testing Ad visory Committee (EDSTAC) and the Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC) are two advisory committees of scientists and stakehol ders that have offered guidance on the development and implementation of the Endocrine Disruptor Program mandated by FQPA.

The State FIFRA Issues Rese arch and Evaluation Group (SFIREG), which consists primarily of state pesticide regulatory offici als, 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 differen ces in pesticide risk for tribal members.

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 pesticid es reach the market sooner and replace older and potentially riskier chemicals. Th e 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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_ accom p lishments.htmReduce pesticide risks to human health Reduce pesticide risks to non-target organisms Reduce the potential for contamin ation 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 reduce d risk pesticide. The Agency expanded the pesticide program to include consider ation of new active ingredients, new uses of active ingredients already deem ed 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 regulate d 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 registrati ons. Collectively, such "minor" crops are important to a healthy diet, and incl ude many fruits and vegetables. Minor uses also include use on commercially gr own flowers, trees and shrubs, certain applications to major crops such as whea t 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 proces s, 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 alleviat e minor use problems. EPA has a staff dedicated to minor use registrations and the Agency works closely with USDA's IR

- 4 program to generate residue data for tolerances on minor crops. Data requirements to support minor uses are carefully considered to minimize the burden of data generati on. EPA and USDA operate early alert systems to notify growers when a pesticid e 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 co nsider maintaining the pesticide use.

Addressing Major Pub lic Policy Challenges

Effective FQPA implementa tion required not only new cutting-edge science policies and operational procedures, but al so 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 sign ificantly the protections for subjects of human research. These regulations:

Prohibit new research for p esticides involvin g intentional ex p osure of 

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_ accom p lishments.htmchildren and pre g nant and nursin g women Extend ethical protections in the Co mmon Rule to other human research involving intentional exposure of non-pregnant, non-nursing adults Require submission to EPA of protocol s 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 St udies Review Board (HSRB), which is made up of world class scientists, and w ill take into serious consideration the scientific and ethical advice and recommendations of HSRB concerning use of human research data in our pesticide risk assessments.

Providing Tailored Attention to Unique Classes of Pesticides

Antimicrobials and biopesticides present different and spec ial challenges from the typical agricultural pesticide. In recogn ition 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 regulati on of antimicrobials and biopesticides. The creation of the Antimicrobials Divi sion and the Biopesticides and Pollution Prevention Division ensure d that these unique materials would be evaluated by highly educated specialists who would ma ke sure that these products receive timely and appropriate scientif ic and regulatory reviews.



### Conclusion

A Bright Future – After a decade of groundbreaking accomplishments, FQPA provisions, principles, and innovative sc ientific 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, wholes ome, and reliable food supplies in the world. With the tools of FQPA, the national pesticide program is equipped to meet the challenges of protecting public he alth and the environment for decades to

come. 

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