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Implementation of Requirements under the Food Quality Protection Act (FQPA)

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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. While this was a formidable task, EPA and its public and private sector partners have worked hard over this 10-year period to make FQPA provisions a reality. The resulting transformation in national pesticide regulation has led to significant enhancements in public health and environmental protection for the American people. This Web site identifies some of the main provisions in the law and describes how the Agency has implemented and carried them out.

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Improved Health Standards for Food Commodities

FQPA Requirement: FQPA requires a new safety standard – reasonable certainty of no harm – that must be applied to all pesticides used on food commodities

Achievement: Tolerances, which are the maximum amount of pesticide residue allowed to remain on food products, are set by EPA as part of the registration and reregistration processes. Under FQPA, EPA must make a safety finding in setting tolerances that the pesticide can be used with "reasonable certainty of no harm." To achieve the new safety standards required by FQPA, EPA has refined its risk assessment methods and added new risk assessments, e.g. aggregate and cumulative. This task sent EPA into novel scientific inquiry and forced the development of cutting edge scientific methods and policy. As a result of EPA's strenuous efforts and inventive solutions, all pesticide tolerances now meet the stringent health standard set by FQPA.

For more information, see Pesticide Tolerances.

FQPA Requirement: FQPA requires EPA to reassess all existing tolerances within 10 years

Achievement: Pesticide tolerances that were in place as of August 1996, when the Food Quality Protection Act was signed, are subject to reassessment under the new safety standards of FQPA. EPA has completed nearly all of this work, having reassessed 9637 or over 99% of the 9,721 tolerances required by FQPA. This reassessment is scheduled to be completed shortly. This complex scientific effort required the detailed review of tens of thousands of studies and test results on toxicity, chemistry, and environmental data.  Notably, this work resulted in the revocation or modification of almost 4,000 food tolerances.

For more information, see Pesticide Tolerance Reassessment & Reregistration.

FQPA Requirement: FQPA requires EPA to set tolerances for residues resulting from uses allowed under FIFRA section 18 emergency exemptions

Achievement: EPA created a program for setting time-limited tolerances for emergency exemptions on an expedited basis. This program, which became operational for the 1996 use season, has enabled EPA to work rapidly and efficiently with our co-regulator States. As a result, there are minimal disruptions in the emergency exemption approval process and maximum efficiency in responding to such situations. EPA has made approximately 500 annual decisions on emergency exemptions most years since 1996.

> For more information, see FIFRA Section 18: Pesticide Emergency Exemptions.

FQPA Requirement: FQPA requires EPA to consider risks to infants and children when setting tolerances

Achievement: In accordance with FQPA, all tolerance decisions take into account the special susceptibility of children to pesticides. EPA has cancelled use of several OP pesticides on many “kid” foods, such as apples, and utilizes an additional tenfold (10X) safety factor as appropriate in setting and reassessing tolerances.

For more information, see Protecting Children from Pesticides.

FQPA Requirement: FQPA requires EPA to consider all "aggregate risk” from exposure to a pesticide from multiple sources when assessing tolerances

Achievement: Through consultation with the FIFRA Scientific Advisory Panel (SAP), the Tolerance Reassessment Advisory Committee (TRAC), and the Committee to Advise on Reassessment and Transition (CARAT), EPA has developed sound scientific procedures for evaluating aggregate exposures to pesticides. These new and improved procedures have enabled EPA to conduct risk assessments that combine exposures from dietary, residential, and drinking water sources, and to ensure that exposure to pesticides in food are safe in light of the aggregate exposure.

> For more information, see Science Policy Issues & Guidance Documents.

FQPA Requirement: FQPA requires EPA to consider "cumulative exposure" to pesticides that have common mechanisms of toxicity

Achievement: EPA has identified four groups of pesticides that share a common mechanism of toxicity: organophosphates (OPs); n-methyl carbamates; triazines; and chloroacetanilides. In assessing cumulative risks, EPA evaluates the potential for people to be exposed to more than one pesticide at a time from a group with an identified common mechanism of toxicity.

For more information, see Assessing Pesticide Cumulative Risk.

FQPA Requirement: EPA developed science policies regarding risk assessments

Achievement: In order to implement the new risk assessment standards, EPA had to develop new science policies. EPA met this challenge by working with the Tolerance Reassessment Advisory Committee, as well as other committees and panels, to identify science policy issues that were key to the implementation of FQPA and tolerance reassessment. New science policies were developed rapidly and effectively, especially in light of the unexplored nature of the scientific areas involved; they represent a significant aspect of EPA's achievements in regard to FQPA. The new science polices include guidelines regarding: a tenfold safety factor; dietary exposure and risk assessment; threshold of regulation; drinking water exposure; residential exposure; aggregate exposure and risk assessment; cumulative risk assessment for pesticides with a common mechanism of toxicity; cholinesterase inhibition end point; and use and usage information.

For more information, see Science Policy Issues & Guidance Documents.

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Reduced Risk Pesticides

FQPA Requirement: FQPA mandates EPA to expedite approval of "reduced risk" pesticides

Achievement: EPA gives priority in its registration program for conventional chemical pesticides to pesticides that meet reduced risk criteria: low-impact on human health; low toxicity to non-target organisms (birds, fish, and plants); low potential for groundwater contamination; lower use rates; low pest resistance potential; and compatibility with Integrated Pest Management.

Some pesticides are by their nature less risky. For example, many biological pesticides are or come from such natural materials as animals, plants, bacteria, and have a non-toxic mode of action; certain minerals also pose a lower risk. For example, canola oil and baking soda have pesticidal applications and are considered biopesticides. These reduced risk and biological pesticides represent 154 of the 248 active ingredients registered by EPA from 1996 through 2005 (62 percent).

For more information, see Reducing Pesticide Risk.

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Minor Uses

FQPA Requirement: FQPA authorized EPA to give special consideration to minor uses

Achievement: Minor use pesticides are of "major" significance for agricultural production and for protecting public health from disease vectors. Without these comparatively small-scale but vital pesticide uses, many of the fruits, vegetables and ornamentals enjoyed in the U.S. and valued at billions of dollars could not be grown successfully. FQPA defines minor use pesticides as pesticides for which the total United States production for a crop is fewer than 300,000 acres, or whose uses do not provide sufficient economic incentive for a registrant to support initial or continuing registrations.

EPA has attempted to make it more economically feasible and beneficial to register minor use pesticides by focusing on registrations for minor use pesticides, and decreasing and sometimes waiving registrant fees. Since 1996, EPA has registered thousands of minor uses. To make this possible, EPA has appointed a Minor Use Coordinator supported by a Minor Use Team, increased communication with minor use stakeholders, and coordinated with the United States Department of Agriculture (USDA) and the Department of Health and Human Services (DHHS). Of particular note is EPA's partnership with the Interregional Research Project No. 4 (IR-4). Through this partnership, EPA has streamlined the minor use registration process, significantly reduced registration times, and made other improvements.

For more information, see New Approaches to Minor Uses.

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Public Health Pesticides

FQPA Requirement: List pests of significant public health importance

Achievement: In 2002 EPA issued, as a cooperative effort with HHS and USDA, the "Lists of Pests of Significant Public Health Importance" (PR Notice 2002-1 (PDF)). (32 pp, 347 KB, About PDF) These lists incorporated comments received in response to the draft list issued in April 2000.

FQPA Requirement: Special consideration to pesticides with public health uses

Achievement: EPA has developed a process in coordination with HHS to consult on public health pesticides. To ensure the benefits of public health uses are fully considered in our regulatory processes, this process has been incorporated in the broader stakeholder process for reregistration. Since the passage of FQPA, EPA has consulted with HHS on approximately 25 pesticides.

EPA coordinates with other federal agencies, user communities, and state and local health departments to obtain as much information as possible on the specific public health benefits.

FQPA Requirement: Encourage the safe and necessary use of methods to combat and control pests of public health importance

Achievement: EPA has appointed a Public Health Official (PHO) charged with implementing and coordinating public health provisions of FQPA. The PHO provides a single public health point of contact to other agencies, state and local governments, user communities, and state and local public health departments with concerns about public health and the use of pesticides. The PHO also assists EPA with public health issues on a variety of topics, ranging from West Nile Virus to proper use techniques to efficacy of pesticides with public health uses.

EPA initiated, and now participates as a member, in a workgroup to identify roadblocks to the development of new public health pesticides or new public health uses for existing pesticides. Other members of this workgroup include CDC, NIH, DoD, USAID, USDA, American Mosquito Control Association, and representatives of industry.

EPA is also working to improve and update its web site to provide more thorough and accurate information on vector control techniques and disease prevention to the general public.

FQPA Requirement: Waivers of maintenance fees for public health pesticides

Achievement: EPA has received several requests for the waiver of maintenance fees for public health pesticides. After careful review, EPA has granted waivers of payment of fees for those pesticides that qualify.

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Antimicrobial Reform

FQPA Requirement: FQPA mandates EPA to expedite review of applications to register antimicrobial products

Achievement: In anticipation of FQPA, EPA implemented a new approach for processing antimicrobials applications for all new chemicals, new uses, and major amendments. This approach was made possible by a reorganization and the allocation of additional resources, and involves examining all applications when they are first received to determine: 1) whether they contain all the necessary and correct forms, data, and labels; and 2) whether the proposed application involves a new use and if so what level of science review, if any, is needed. If there is a problem with the application, EPA staff contacts the registrant to correct the matter as quickly as possible. By carefully reviewing applications and determining "up-front" how best to use the information provided, it is possible to evaluate applications with less extensive data and a simpler process. In addition, improved efficiency has allowed limited resources to be conserved for other applications and activities where their use is more warranted and needed. From FY 1998 through 2003, AD registered 1,127 products and amended 8,206 product registrations, all of which were completed on time. EPA continues to register antimicrobial products with the additional funds allocated under the Pesticide Registration Improvement Act (PRIA) of 2003.  PRIA further improved the Agency’s efficiency in registering certain types of pesticides, including antimicrobials, and has resulted in an even greater decision-making capacity.

> For more information, see Guidance for AD Review of Applications for New Chemicals, New Uses, and Major Amendments.

FQPA Requirement: FQPA exempted certain antimicrobial pesticides from the pesticide container provisions of FIFRA

Achievement: EPA discussed this exemption for certain household, industrial and institutional antimicrobial pesticides in a 1999 Federal Register notice on the Pesticide Container-Containment rule and carefully considered the public comments on this topic. The Agency will address this exemption of certain antimicrobial pesticides in the final Container-Containment rule, which is scheduled to be published in August 2006.

> For more information, see Container and Containment Rule.

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Endocrine Disruption

FQPA Requirement: FQPA requires EPA to screen pesticides for endocrine disruption

Achievement: Through the establishment of subcommittees and advisory committees, EPA has developed the Endocrine Disruptor Screening Program (EDSP) with the advice and opinions of experts and stakeholders. EPA will screen pesticide ingredients for their potential to disrupt the endocrine system.

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Registration Review

FQPA Requirement: FQPA requires periodic review of pesticide registrations (with a goal of every 15 years)

Achievement: Procedural regulations for the registration review of pesticides were signed on August 1, 2006, published in the Federal Register on August 9, 2006, and become effective on October 10, 2006.  Under these rules, EPA will aim to review each pesticide's registration every 15 years to assure that the pesticide still meets the FIFRA standards for registration.

Changes in science, public policy, and pesticide use practices will occur over time. Through the new registration review program, the Agency will periodically reevaluate pesticides to make sure that as change occurs, products in the marketplace can continue to be used safely. The registration review program challenges EPA to continuously improve its processes, science, and information management while maintaining a collaborative and open process for decision-making. This new program requires EPA to periodically review all registered pesticides. The public will always be assured that pesticide registrations are updated to meet current scientific and regulatory standards.

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Fee Collection

FQPA Requirement: FQPA mandated changes in tolerance fee collection

Achievement: FQPA increased the amount of user fees available to complete the review of older pesticides from $14 million to $16 million per year. These reviews include the reassessment of tolerances, and ensure that all pesticides meet current standards. Since the passage of FQPA, the Pesticide Registration Improvement Act (PRIA) of 2003 renewed collection fees and further bolstered fees collected for certain types of pesticides for an additional five years. PRIA has helped make the timing of the decision-making process more predictable for affected pesticide decisions.

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USDA Initiatives

FQPA Requirement: FQPA requires food consumption surveys

Achievement: USDA's Food Surveys Research Group monitors and assesses food consumption and related behavior of the U.S. population by conducting surveys.  USDA provides results from these surveys to food and nutrition-related programs, which then take the data into account when making public policy decisions.  EPA uses these data when setting tolerances for pesticide residues on food commodities.

FQPA Requirement: FQPA requires the collection of pesticide residue data

Achievement: USDA's Pesticide Data Program (PDP) monitors the levels of pesticide residues in raw and processed agricultural commodities and maintains a national pesticide residue database. PDP manages the collection, analysis, data entry, and reporting of pesticide residues on a nationally representative sample of agricultural commodities in the U.S. food supply with an emphasis on those commodities highly consumed by infants and children. PDP data are published annually and play an essential role in EPA's tolerance reassessment process.

FQPA Requirement: FQPA requires the collection of pesticide use data

Achievement: USDA's National Agricultural Statistics Service (NASS) conducts annual surveys and prepares reports covering virtually all aspects of U.S. agriculture.  NASS data on pesticide use describes at the state level commodity acreages and active ingredient (ai) chemical use (percent crop treated, average ai applied/acre/treatment, average number of treatments, average ai applied/acre/crop year, total ai applied).  These data play a key role in both EPA's risk and benefits assessments.

FQPA Requirement: FQPA requires the promotion of Integrated Pest Management (IPM)

Achievement: USDA's IPM program supports projects that develop and implement IPM practices, tactics and systems for specific pest problems while reducing human and environmental risks. In cooperation with Regional IPM Centers and Land-grant University Partners, the IPM program has provided grants to various organizations and has been a strong advocate of IPM. The existence of IPM systems helps farmers adjust more smoothly to changes in pesticide use required through EPA's reregistration and tolerance reassessment programs.

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Integrated Pest Management (IPM)

FQPA Requirement: FQPA requires EPA to implement IPM education programs

Achievement: As stated above, EPA works closely with regional offices and USDA's Cooperative State Research, Education, and Extension Services to conduct IPM training for at-risk populations. In addition, the Agency has collaborated with the Centers for Disease Control (CDC) to include IPM practices in the “Keep it Pest Free” training series, which educates public health and housing officials on how to reduce environmental health hazards in low income housing. This program is carried out by five university-based training centers and manages to reach approximately 1500 officials per year. EPA has also helped CDC incorporate IPM into their place-based goal strategies for improving public health.

Through the Hispanic outreach program, EPA has extended itself to a significant portion of this at-risk population. Over the past two years, EPA has provided practical and invaluable information on IPM to approximately 10 million Hispanics through national and local TV, radio, and print ads.

FQPA Requirement: FQPA requires EPA to implement IPM Research and Demonstration

Achievement: EPA promotes the implementation of IPM through several programs, partnership, and initiatives. In the urban setting, EPA funds pilot programs that seek to launch and maintain viable IPM methods in both schools and low-income housing. The IPM in Schools Initiative has already positively affected millions of children across the Nation, and has significantly reduced exposure of affected school children to toxic pesticides. EPA has also worked closely with the National Center for Healthy Housing and the Department of Housing and Urban Development (HUD) to develop regulations, policies and guidance for public housing authorities in regards to IPM implementation. In addition, the Agency has developed evaluation tools, such as IPM Star—an objective and transparent auditing process—to determine if facilities are using effective IPM techniques.

The Pesticide Environmental Stewardship Program (PESP) encourages IPM research and implementation through voluntary partnerships with over 170 members who are committed to reducing the potential risks associated with pesticide use. EPA's partnership with the Department of Defense (DoD) has been particularly fruitful, resulting in the establishment of IPM plans in all military facilities. Closely related to implementation of IPM programs is the Strategic Agricultural Initiative (SAI). SAI is EPA's incentive-based program to help farmers transition to lower-risk pest control practices, while adopting new biologically based pesticide products—a crucial aspect of IPM. SAI has helped implement reduced risk pest management strategies on over 780,000 acres of farmland and has led to at least a 30 percent reduction of higher-risk pesticide use on affected acres.

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Harmonization of Standards and Requirements

FQPA Requirement: FQPA encourages the harmonization of tolerances with international standards, as established by Codex

Achievement: Working with other NAFTA countries through the Technical Working Group (TWG), the Agency has been able to standardize many of the scientific tools used among NAFTA countries in pesticide review, registration, and standards-setting. Much of this common set of tools, including the Maximum Residue Limit (MRL) Calculator, has also been adopted by the Codex Alimentarius Commission, a joint FAO/WHO Food Standards Program, and are now used on a much larger international scale. As a result of this international harmonization of regulatory programs, pesticide tolerances are now more consistent across borders, and standards for the protection of human health and the environment have been raised. In addition, international harmonization has increased the benefits from shared scientific and technical expertise, lessened the resource burden on governments and the regulatory community, and minimized trade problems.

FQPA Requirement: FQPA requires national uniformity of tolerances

Achievement: Under FQPA, States may not set tolerance levels that differ from national levels unless the state petitions EPA for an exception, based on state-specific situations. While this was becoming a contentious issue in the 1990s, EPA has since been able to significantly reduce the controversy by virtue of completing the tolerance reassessments required by FQPA. These tolerances are now uniformly accepted and used across the Nation.

FQPA Requirement: FQPA mandated EPA to coordinate Federal and State data requirements

Achievement: In early 1997, the Agency formed an EPA-state-industry workgroup to evaluate the extent to which states and EPA were imposing different data requirements for pesticides. After careful consideration, the workgroup concluded in August of 1997 that there was not a meaningful discrepancy between Federal and state data requirements. The workgroup also noted and encouraged greater cooperation between EPA and California in performing joint reviews of residue chemistry data. EPA and California continue to cooperate, completing 25 joint reviews for IR-4 actions in 2005. This allows both the Agency and California to save resources and complete more regulatory actions in less time by avoiding duplicative efforts.

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Consumer-Right-to-Know

FQPA Requirement: FQPA mandates development and distribution of a food safety brochure on health effects of pesticides

Achievement: EPA has developed a Web page and brochure with the advice of stakeholders to answer questions about pesticides and food. Well over six million copies of this brochure, entitled, "Pesticides and Food: What You and Your Family Need to Know," have been distributed to more than 30,000 grocery stores, public health officials, libraries, and the medical community. In addition, EPA makes pesticide information widely available to the public through its web site, listserves, and public meetings. EPA also responds on a regular basis to inquiries from concerned citizens.

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Performance Reports

FQPA Requirement: FQPA mandated EPA to report annually on the progress of its reregistration program

Achievement: Beginning in 1997, EPA has published in the Federal Register annual reports summarizing its progress in meeting performance measures and goals for pesticide registration and tolerance reassessment.

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