Food Quality Protection Act
Encyclopedia
The Food Quality Protection Act (FQPA), or H.R.1627, was passed unanimously by Congress in 1996 and was signed into law by former U.S. President Bill Clinton
on August 3, 1996. The FQPA standardized the way the Environmental Protection Agency (EPA) would manage the use of pesticides and amended the Federal Insecticide, Fungicide, and Rodenticide Act
and the Federal Food Drug and Cosmetic Act. It mandated a health-based standard for pesticides used in foods, provided special protections for babies and infants, streamlined the approval of safe pesticides, established incentives for the creation of safer pesticides, and required that pesticide registrations remain current.
One of the most prominent sections of the act, the specified protections for babies and infants, was the topic of the National Academy of Science's 1993 report, Pesticides in the Diets of Infants & Children. The EPA has cited this report as a catalyst for the creation of the FQPA.
. The Delaney clause, an amendment of the Federal Food Drug and Cosmetic Act, banned all food that contained any trace amount of any pesticide that may cause cancer. Although the EPA argued that the legislation was outdated and should not apply to the current situation, the coalition won in 1995 and the EPA was slated to ban 80 pesticides in late 1996. Under these new, more urgent circumstances, Congress was able to pass a bill that was celebrated by both sides of the debate; farmers, food processors and pesticide manufactures were glad to see the Delaney Clause go, while environmental groups and consumer advocates were pleased to have a formalized safety standard with an added emphasis on children. John Cady, president of the National Food Processors Association, praised the legislation for being "...based on modern, real-world science".
. To do this the EPA is required to establish new science polices to asses the risks. The FQPA requires the EPA to set tolerances for pesticide uses that fall under section 18 of the Federal Insecticide, Fungicide and Rodenticide Act (emergency exemptions).
.
and to give special consideration to pesticides with public health uses. The EPA is also required provide maintenance fee waivers to and encourage the safe and necessary use of methods/pesticides that either combat or control pests that have been deemed of public health importance. The EPA also provides waiver fees for the pesticides used on pests that are deemed of public health importance.
products. The FQPA also exempts certain antimicrobial products from the container provisions in the Federal Insecticide, Fungicide and Rodenticide Act.
solutions.
. The FQPA requires the EPA to establish an integrated pest management education program and implement integrated pest management research and demonstration. The FQPA encourages the syncing of U.S. pesticide tolerances with those of international standards. Under the FQPA individual states are not allowed to set different pesticide tolerances than the EPA and the EPA is requiored to coordinate data requirements between the state and federal levels. The EPA is required to develop and distribute a food safety brochure and create an annual report on the progress of its registration program.
While the EPA did limit, and in some cases ban, the use of pesticides following the passing of the FQPA, not every stakeholder was pleased with their level of action. Referring to the discrepancies between what constitutes reliable data when determining whether or not to increase the margin of safety tenfold, Richard Weiss (a pesticide expert with the Environmental Working Group
) said, "The EPA has failed to comply with the clear intent and requirements of the law". While environmentalists complained so did farmers; as their ability to harvest quality crops was threatened farmers said the EPA was unfairly enforcing a "zero risk" instead of a "reasonable certainty of no harm" policy. The EPA responded saying that while they were more stringent after the passing of the FQPA, they were not operating under a no risk/no harm rule.
In 1999, the EPA banned most uses of methyl parathion and azinphos methyl, citing the risks they pose to children. Both methyl parathion and azinphos methyl are organophosphates. Organophosphates are pesticides that kill insects by disrupting nerve impulses. Unfortunately, these pesticides have the same effect on humans. In 2000, the EPA banned another organophosphate, (chlorpyrifos
), that was common in the agriculture industry, household cleaners and commercial pest control products due to a study showing that chlorpyrifos caused weakness, vomiting and diarrhoea in baby rats.
The restrictions on these pesticides, although mandated on the premise of child safety, were not received unanimously well by groups outside the EPA. Both agriculture representatives and environmentalists sounded off after the EPA made its decisions. “Chemical Business News” published an article suggesting that the idea that pesticides pose special dangers for children was actually an alarmist issue not based in science. Agriculture lobbies claimed that the banning of organophosphates would cause the agriculture industry an annual loss of $1.8 billion. Environmentalists argued that the EPA was buckling under the pressure of these lobbies and needed to uphold the legal safety standard mandated in the FQPA. In response the EPA published a report saying that they stood by their decisions and the 10 fold safety increase was both conservative and prudent and was only applicable under special circumstances.
argued that clinical studies were both inaccurate and ethically wrong; pesticide manufacturers argued that not only were clinical studies crucial but that they must be allowed to conduct the tests to determine "No observable adverse effects level", meaning they administer the drug until an effect is observed.
The National Academy of Sciences released a report in 2004 supporting the use of clinical studies under strict regulations; the regulations mandated that the study's benefit to society outweigh the risk to the individual, that the study be conducted under a strict ethical code, that there be reasonable certainty that no harm will come to participants and that it has been shown to other study will work. In 2005, adhering to a congressional directive, the EPA adopted the Human Studies Regulation; the regulations permit human studies, do not allow the use of pregnant women or children in human studies, mandate that a strict ethical code be followed and establish a Human Studies Review Board to oversee the use of human studies. The EPA considers the regulations as a major accomplishment in public policy.
Bill Clinton
William Jefferson "Bill" Clinton is an American politician who served as the 42nd President of the United States from 1993 to 2001. Inaugurated at age 46, he was the third-youngest president. He took office at the end of the Cold War, and was the first president of the baby boomer generation...
on August 3, 1996. The FQPA standardized the way the Environmental Protection Agency (EPA) would manage the use of pesticides and amended the Federal Insecticide, Fungicide, and Rodenticide Act
Federal Insecticide, Fungicide, and Rodenticide Act
The Federal Insecticide, Fungicide, and Rodenticide Act , et seq. is a United States federal law that set up the basic U.S. system of pesticide regulation to protect applicators, consumers, and the environment. It is administered by the Environmental Protection Agency and the appropriate...
and the Federal Food Drug and Cosmetic Act. It mandated a health-based standard for pesticides used in foods, provided special protections for babies and infants, streamlined the approval of safe pesticides, established incentives for the creation of safer pesticides, and required that pesticide registrations remain current.
One of the most prominent sections of the act, the specified protections for babies and infants, was the topic of the National Academy of Science's 1993 report, Pesticides in the Diets of Infants & Children. The EPA has cited this report as a catalyst for the creation of the FQPA.
Background
Legislation similar to the FQPA was drafted and presented to Congress in 1995 but was never acted on. In 1996, the political landscape had changed and new pressures to act on pesticide control reform surfaced. In 1991, a coalition of environmental groups sued the EPA for failing to enforce the Delaney clauseDelaney clause
The Delaney Clause is a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938, named after Congressman James Delaney of New York.It said:...
. The Delaney clause, an amendment of the Federal Food Drug and Cosmetic Act, banned all food that contained any trace amount of any pesticide that may cause cancer. Although the EPA argued that the legislation was outdated and should not apply to the current situation, the coalition won in 1995 and the EPA was slated to ban 80 pesticides in late 1996. Under these new, more urgent circumstances, Congress was able to pass a bill that was celebrated by both sides of the debate; farmers, food processors and pesticide manufactures were glad to see the Delaney Clause go, while environmental groups and consumer advocates were pleased to have a formalized safety standard with an added emphasis on children. John Cady, president of the National Food Processors Association, praised the legislation for being "...based on modern, real-world science".
Improved health standards for food commodities
The FQPA established a new safety standard (reasonable certainty of no harm) that must be applied to all food commodities. In addition to the new standard the EPA now has to consider the specific risks pesticides might have for infants and children. The FQPA required the re-testing of all existing pesticide tolerance levels within 10 years. When assessing this risk the EPA is required to take into account the “aggregate risk” (the exposure to a pesticide from multiple sources) and the “cumulative exposure” to pesticides with similar mechanisms of toxicityToxicity
Toxicity is the degree to which a substance can damage a living or non-living organisms. Toxicity can refer to the effect on a whole organism, such as an animal, bacterium, or plant, as well as the effect on a substructure of the organism, such as a cell or an organ , such as the liver...
. To do this the EPA is required to establish new science polices to asses the risks. The FQPA requires the EPA to set tolerances for pesticide uses that fall under section 18 of the Federal Insecticide, Fungicide and Rodenticide Act (emergency exemptions).
Reduced risk pesticides
The FQPA mandates that the EPA expedite the approval of reduced risk pesticides. To be considered reduced risk pesticides must have a proven low-impact on human health, have low toxicity to non-target organisms and have a low potential to contaminate groundwaterGroundwater
Groundwater is water located beneath the ground surface in soil pore spaces and in the fractures of rock formations. A unit of rock or an unconsolidated deposit is called an aquifer when it can yield a usable quantity of water. The depth at which soil pore spaces or fractures and voids in rock...
.
Minor uses
The FQPA requires the EPA to give special consideration to pesticides used on products that have less than 300,000 acres of total U.S. production or products that do not have enough economic incentive to either support an initial registration or a continuing registration.Public health pesticides
The FQPA requires the EPA to establish a list of pests that are considered significant to public healthPublic health
Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals" . It is concerned with threats to health based on population health...
and to give special consideration to pesticides with public health uses. The EPA is also required provide maintenance fee waivers to and encourage the safe and necessary use of methods/pesticides that either combat or control pests that have been deemed of public health importance. The EPA also provides waiver fees for the pesticides used on pests that are deemed of public health importance.
Antimicrobial reform
The FQPA mandates the EPA to expedite the review of applications that are requesting the registration of antimicrobialAntimicrobial
An anti-microbial is a substance that kills or inhibits the growth of microorganisms such as bacteria, fungi, or protozoans. Antimicrobial drugs either kill microbes or prevent the growth of microbes...
products. The FQPA also exempts certain antimicrobial products from the container provisions in the Federal Insecticide, Fungicide and Rodenticide Act.
USDA initiatives
The FQPA requires the conduction of food consumption surveys that track food consumption and related behaviors in the U.S. population. The FQPA mandates the collection of pesticide residue and use data. The FQPA mandated the promotion of integrated pest managementIntegrated Pest Management
Integrated pest management is an ecological approach to agricultural pest control that integrates pesticides/herbicides into a management system incorporating a range of practices for economic control of a pest...
solutions.
Other
The FQPA requires that pesticide registration be reviewed periodically, with a goal of once every 15 years. The FQPA mandated changes in the collection of tolerance fee’s, increasing the amount of fee money from $14 million to $16 million to help with the reassessment of tolerances. The FQPA requires the EPA to specifically screen pesticides for disruption to the endocrine systemEndocrine system
In physiology, the endocrine system is a system of glands, each of which secretes a type of hormone directly into the bloodstream to regulate the body. The endocrine system is in contrast to the exocrine system, which secretes its chemicals using ducts. It derives from the Greek words "endo"...
. The FQPA requires the EPA to establish an integrated pest management education program and implement integrated pest management research and demonstration. The FQPA encourages the syncing of U.S. pesticide tolerances with those of international standards. Under the FQPA individual states are not allowed to set different pesticide tolerances than the EPA and the EPA is requiored to coordinate data requirements between the state and federal levels. The EPA is required to develop and distribute a food safety brochure and create an annual report on the progress of its registration program.
Impact
The FQPA was the most comprehensive reform of food safety and pesticide laws in decades and posed an implementation challenge for the EPA. Immediately following the passing of the FQPA, the EPA moved to create the Food Safety Advisory Committee. The committee was founded with the intention of fostering an open and public implementation process. Within 10 years, the EPA had successfully reassessed 99% of the nations pesticide tolerances (recommending the revocation of 3,200, recommending the modification of 1,200 and approving 5,237). In addition to the reassessing of pesticide tolerances, the EPA accommodated the use of special classes of pesticides, addressed the public policy issue of clinical studies to verify pesticide effects, and expedited the availability of safe pesticides.While the EPA did limit, and in some cases ban, the use of pesticides following the passing of the FQPA, not every stakeholder was pleased with their level of action. Referring to the discrepancies between what constitutes reliable data when determining whether or not to increase the margin of safety tenfold, Richard Weiss (a pesticide expert with the Environmental Working Group
Environmental Working Group
The Environmental Working Group is an American environmental organization that specializes in research and advocacy in the areas of toxic chemicals, agricultural subsidies, public lands, and corporate accountability...
) said, "The EPA has failed to comply with the clear intent and requirements of the law". While environmentalists complained so did farmers; as their ability to harvest quality crops was threatened farmers said the EPA was unfairly enforcing a "zero risk" instead of a "reasonable certainty of no harm" policy. The EPA responded saying that while they were more stringent after the passing of the FQPA, they were not operating under a no risk/no harm rule.
Emphasis on children
The passing of the FQPA marked the first time the EPA was asked to directly address the risks pesticides pose for infants and children. Because children are smaller, the pesticides they ingest have a proportionately greater impact. The FQPA required the EPA to enforce a safety margin 10 times greater than before if reliable data proving that the pesticide posed no risk for children could not be provided. After the bills passing, former President Bill Clinton said, "If a pesticide poses a danger to our children, then it won’t be in our food".In 1999, the EPA banned most uses of methyl parathion and azinphos methyl, citing the risks they pose to children. Both methyl parathion and azinphos methyl are organophosphates. Organophosphates are pesticides that kill insects by disrupting nerve impulses. Unfortunately, these pesticides have the same effect on humans. In 2000, the EPA banned another organophosphate, (chlorpyrifos
Chlorpyrifos
Chlorpyrifos is a crystalline organophosphate insecticide that inhibits acetylcholinesterase and is used to control insect pests. It is known by many trade names...
), that was common in the agriculture industry, household cleaners and commercial pest control products due to a study showing that chlorpyrifos caused weakness, vomiting and diarrhoea in baby rats.
The restrictions on these pesticides, although mandated on the premise of child safety, were not received unanimously well by groups outside the EPA. Both agriculture representatives and environmentalists sounded off after the EPA made its decisions. “Chemical Business News” published an article suggesting that the idea that pesticides pose special dangers for children was actually an alarmist issue not based in science. Agriculture lobbies claimed that the banning of organophosphates would cause the agriculture industry an annual loss of $1.8 billion. Environmentalists argued that the EPA was buckling under the pressure of these lobbies and needed to uphold the legal safety standard mandated in the FQPA. In response the EPA published a report saying that they stood by their decisions and the 10 fold safety increase was both conservative and prudent and was only applicable under special circumstances.
Clinical studies debate
In 1998, the EPA placed a moratorium on clinical studies, or human studies, citing both ethical and scientific concerns. While the use of clinical studies for pesticide tolerances had been in decline since the 1980s, the passing of the FQPA re-generated interest in the practice. By testing on humans, pesticide manufacturers could eliminate the additional safety margins required when using data collected from animal testing. Following their moratorium the EPA had the National Academy of Sciences convene a panel of experts to determine the ethical solution to the human studies debate. While the National Academy of sciences established the panel, both pesticide manufactures and environmentalists established their own opinions. The Environmental Working Group and the Natural Resources Defense CouncilNatural Resources Defense Council
The Natural Resources Defense Council is a New York City-based, non-profit, non-partisan international environmental advocacy group, with offices in Washington DC, San Francisco, Los Angeles, Chicago, and Beijing...
argued that clinical studies were both inaccurate and ethically wrong; pesticide manufacturers argued that not only were clinical studies crucial but that they must be allowed to conduct the tests to determine "No observable adverse effects level", meaning they administer the drug until an effect is observed.
The National Academy of Sciences released a report in 2004 supporting the use of clinical studies under strict regulations; the regulations mandated that the study's benefit to society outweigh the risk to the individual, that the study be conducted under a strict ethical code, that there be reasonable certainty that no harm will come to participants and that it has been shown to other study will work. In 2005, adhering to a congressional directive, the EPA adopted the Human Studies Regulation; the regulations permit human studies, do not allow the use of pregnant women or children in human studies, mandate that a strict ethical code be followed and establish a Human Studies Review Board to oversee the use of human studies. The EPA considers the regulations as a major accomplishment in public policy.
See also
- Federal Food, Drug, and Cosmetic ActFederal Food, Drug, and Cosmetic ActThe United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
- Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
- Food qualityFood qualityFood quality is the quality characteristics of food that is acceptable to consumers. This includes external factors as appearance , texture, and flavour; factors such as federal grade standards and internal .Food quality in the United States is enforced by the Food Safety Act 1990...