Food Quality Protection Act FQPA

In 1996, the US Senate and House of Representatives passed the Food Quality Protection Act (FQPA). In order to make their exposure and risk assessments as accurate as possible, the US ERA Office of Pesticide Programs (OPP) has established guidelines to determine a value to assign for NDs. These guidelines can be summarized... 

In the USA, the passage of the Food Quality Protection Act (FQPA) of 1996 has had a significant impact on the determination of residues in drinking water. FQPA requires that all sources of a pesticide be included in its risk assessment, so the potential exposure from drinking water containing a particular pesticide could be a significant... 

The second milestone event in the USA in the 1990s was passage of the Food Quality Protection Act (FQPA) in 1996. The goal of the FQPA was to assure a reasonable certainty of no harm as a result of exposure to pesticides for all US population groups. The FQPA incorporated into federal law the major recommendations of the 1993 National Academy of Sciences (NAS)/NRC report, as well as the recommendations of a 1987 NAS/NRC report entitled Regulating Pesticides in Food The Delaney Paradox (National Research Council, 1987). 

The Food Quality Protection Act (FQPA) of 1996 mandated that the US EPA carry out risk assessments that consider the cumulative effects of exposure to pesticides having a common mechanism of toxicity, as well as consider exposure to each pesticide by various routes of exposure (e.g., dermal, dietary, inhalation) and sources (e.g., residues in food and water) in an aggregate manner [19]. To accomplish this, there needs to be sufficient evidence supporting a common adverse effect that is associated with a common mechanism of action in specific target tissues. To date, the required criteria necessary to establish a common mechanism of toxicity with a specific toxic effect for the pyrethroids are not available [1,8,98]. 

Under the Food Quality Protection Act (FQPA), the U.S. EPA evaluates the potential for people to be exposed to more than one pesticide at a time from a group of chemicals with an identified common mechanism of toxicity. As part of the examinations, to clarify whether some or all of the pyrethroids share a common mechanism of toxicity, a comparative FOB (functional observational battery) studies with 12 pyrethroids were carried out under standardized conditions [15]. The FOB was evaluated at peak effect time following oral administration of non-lethal doses of pyrethroids to rats using com oil as vehicle. Four principal components were observed in the FOB data [22], Two of these components described behaviors associated with CS syndrome (lower body temperature, excessive salivation, impaired mobility) and the others described behaviors associated with the T syndrome (elevated body temperature, tremor myoclonus). From the analysis, pyrethroids can be divided into two main groups (Type I T syndrome and Type II CS syndrome) and a third group (Mixed Type) that did not induce a clear typical response. Five other pyrethroids were also classified by an FOB study conducted in the same manner [16]. The results of these classifications are shown in Table 1. The FOB results for all non-cyano pyrethroids were classified as T syndrome, and the results of four ot-cyano pyrethroids were classified as CS syndrome however, three of the ot-cyano pyrethroids, esfenvalerate, cyphenothrin, and fenpropathrin, were classified as Mixed Type. 

On August 3, 1996, President Clinton signed into law the Food Quality Protection Act (FQPA). The new law required major changes in pesticide regulation and afforded the Environmental Protection Agency (EPA) unprecedented opportunities to provide greater health and environmental protection, particularly for infants and children. The FQPA required the EPA to review the more than 9,700 tolerances established before August 3, 1996 (the... 

The question of an extra assessment factor in the hazard and risk assessment for chemicals of concern for children is specifically addressed in Section 5.2.1.13. The U.S. Food Quality Protection Act (FQPA) (US-EPA 1996) directed the US-EPA to apply an extra safety factor of 10 in assessing the risks of pesticides to infants and children. The US-EPA (2002) noted the overlap of areas covered by the FQPA factor and those addressed by the traditional UFs, and it was concluded that an additional UF (children-specific) is not needed in the setting of reference values because the currently available UFs (interspecies, intraspecies, LQAEL-to-NOAEL, subchronic-to-chronic, and database-deficiency) were considered sufficient to account for uncertainties in the database from which the reference values are derived. Renwick et al. (2000) concluded that the available data did not provide a scientific rationale for an additional 10-fold UF for infants and children and pointed out that when adequate reproduction, multigeneration, or developmental studies are conducted, there will be no need for an additional 10-fold factor. 

Methyl parathion is used primarily on cotton. It was one of the first insecticides restricted under the 1996 Food Quality Protection Act (FQPA), which developed new safety standards for human health, especially that of children. It can no longer be used on many fruits and vegetables. Malathion and parathion are the broadest spectrum organophosphate insecticides. There are many other organophosphate insecticides in use in the U.S. today. Many are produced at the 1-5 million Ib/yr level for specific applications. Three other leading organophosphates besides those mentioned already are chlorpyrifos, terbufos, and phorate. 

The Food Quality Protection Act (FQPA) requires the EPA to conduct a review of pesticides that pose the most danger to human health. The EPA must make sure the pesticides meet new safety standards specifically designed to protect children. 

USEPA (1996) Food Quality Protection Act (FQPA) of 1996 http //www.epa.gov/ pesticides/regulating/laws/fqpa/ (last accessed 30 April 2010). 

The 1996 Food Quality Protection Act (FQPA) now requires that an additional safety factor of 10 be used in the risk assessment of pesticides to ensure the safety of infants and children, unless the EPA can show that an adequate margin of safety is assured with out it (Scheuplein, 2000). The rational behind this additional safety factor is that infants and children have different dietary consumption patterns than adults and infants, and children are more susceptible to toxicants than adults. We do know from pharmacokinetics studies with various human pharmaceuticals that drug elimination is slower in infants up to 6 months of age than in adults, and therefore the potential exists for greater tissue concentrations and vulnerability for neonatal and postnatal effects. Based on these observations, the US EPA supports a default safety factor greater or less than 10, which may be used on the basis of reliable data. However, there are few scientific data from humans or animals that permit comparisons of sensitivities of children and adults, but there are some examples, such as lead, where children are the more sensitive population. It some cases qualitative differences in age-related susceptibility are small beyond 6 months of age, and quantitative differences in toxicity between children and adults can sometimes be less than a factor of 2 or 3. 

The aggregate and cumulative assessments required by the 1996 Food Quality Protection Act (FQPA) when sufficient data are available combine the water, diet, and nondietary pathways (e.g., residential users), but exclude occupational pathways. The aggregate and cumulative assessments in this chapter include not only residential users, but also occupational herbicide handling by growers and commercial operators. Thus, the corresponding aggregate and cumulative assessments for atrazine and simazine in this chapter estimate more exaggerated doses than required by FQPA. 

The Food Quality Protection Act (FQPA) represents amendments to FIFRA as well as FFDCA. These amendments fundamentally change the way EPA regulates pesticides. The requirements included a new safety standard for ensuring a reasonable certainty of no harm that must be applied to all pesticides used on foods. Readers interested in the FQPA should check the Web site at http //www.epa.gov/pesticides/regulating/laws/fqpa. This Web site provides background information on the provisions of FQPA and discusses some of the specific issues raised by FQPA as well as status of implementation of this important new law. The following are some important changes (FQPA, 1996). 

Anonymous (1997). The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Federal Food, Drug, and Cosmetic Act (FFDCA) As Amended by the Food Quality Protection Act (FQPA) of August 3,1996, U.S. Environmental Protection Agency, Publication No. 730L97001,1997. 

The Food Quality Protection Act (FQPA) in the USA and the Pest Control Products Act (PCPA) in Canada mandate that potential risks to infants and small children be specifically addressed. When assessing the food use of a pesticide, in order to assure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide s chemical residues , the FQPA and PCPA in the case of threshold effects call for an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure to be applied to estimating risks to infants and children. A different margin of safety may be used only if, on the basis of reliable data, such a margin will be safe for infants and children. In Canada, these same requirements also apply to non-food-use pesticides. 

The USEPA has spearheaded a similar tiered approach for application and post-application in residential exposure scenarios. With the US Food Quality Protection Act (FQPA) as impetus, the USEPA has developed a series of algorithms which yield Tier 1 estimates for a broad range of residential application and post-application exposure scenarios. Approximately 40 unique scenarios are addressed in the USEPA s draft Standard Operating Procedure for Residential Exposure Assessment (USEPA, 1997c). Although some jurisdictions, including Canada, have adopted some of these algorithms. Tier 1 approaches for residential scenarios have not been the subject of substantial international discussion to date. 

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