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Act Accomplishments under FQPA 

Accomplishments under the Food Quality 

Protection Act (FQPA) 

August 3, 2006 -- 10th Anniversary 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 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. 

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Quick Resources 

FQPA

FQPA Home 

FQPA Background 

Accomplishments under 

FQPA 

Implementation of 

Requirements under FQPA 

Related Pesticides 

Resources

Tolerance Reassessment 

Endocrine Disruptors 

Science Policies 

Pesticides: Regulating Pesticides 

http://www.epa.gov/opp00001/regulating/laws/fqpa/fqpa_accomplishments.htm

Last updated on Wednesday, May 09, 2012

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Overview 

Notable Achievements

Expanded Scope of Protection 

Timely Reassessments 

Advancing Science 

Opening up the Process 

Establishing Partnerships 

Meeting Needs for Safe, Effective 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 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. 

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. 

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 

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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: 

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: 

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 

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 non-occupational 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: 

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 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 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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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. 

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: 

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 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. 

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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. 

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 

information-intensive 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 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. 

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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: 

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 include: 

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) , the World Health Organization 

(WHO) , and Codex . 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 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. 

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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. 

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: 

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. 

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 to 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. 

Addressing Major Public Policy Challenges

Effective FQPA implementation required not only new cutting-edge science 

policies and 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: 

Prohibit new research for pesticides involving intentional exposure of 

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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. 

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. 

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 pesticide program is equipped to meet 

the challenges of protecting public health and the environment for decades to 

come. 

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