Data Quality Act

Sass, J. B. and Devine, J. P., The centre for regulatory effectiveness invokes the data quality act to reject published studies on atrazine toxicity, Environ. Health Perspect., 112, A18,2004. 

Clean Air Act of 1970 The Clean Air Act of 1970 was founded on the concept of attaining National Ambient Air Quahty Standards (NAAQS). Data were accumulated and analyzed to establish the quality of the air, identify sources of pollution, determine how pollutants disperse and interac t in the ambient air, and define reduc tions and controls necessary to achieve air-quahty objectives. 

In addition to the processed commodities listed in the Series 860 Table 1, some registrants choose also to provide data on other processed fractions. With the advent of the Food Quality Protection Act of 1996 and the emphasis on protecting the food supply for children, collecting residue data on additional processed commodities may be prudent. Fruit purees are popular as baby food in the USA and are an example of a processed commodity that could come under additional scrutiny since they make up a large portion of an infant diet. 

One common objective of an LSMBS is to refine the estimates of actual exposure of consumers to ingredients or impurities in one or more products. For example, study results might be intended to determine a realistic human dietary exposure to pesticide residues in fresh fruits and vegetables. The advent of the Food Quality Protection Act of 1996 (FQPA) has produced an enhanced focus on the exposure of children to pesticides. A well-designed and implemented LSMBS would afford the opportunity to delineate better the exposure and risk to children and other population subgroups. The LSMBS would provide consumer-level data at or near the point of consumption, allowing the refined, relevant, and realistic assessments of dietary exposure. 

The quantity and quality of experimental information determined by the new techniques call for the use of comprehensive data treatment and evaluation methods. In earlier literature, quite often kinetic studies were simplified by using pseudo-first-order conditions, the steady-state approach or initial rate methods. In some cases, these simplifications were fully justified but sometimes the approximations led to distorted results. Autoxidation reactions are particularly vulnerable to this problem because of strong kinetic coupling between the individual steps and feed-back reactions. It was demonstrated in many cases, that these reactions are very sensitive to the conditions applied and their kinetic profiles and stoichiometries may be significantly altered by changing the pH, the absolute concentrations and concentration ratios of the reactants, and also by the presence of trace amounts of impurities which may act either as catalysts and/or inhibitors. 

Under the Potable Water Regulation of the New Brunswick Clean Water Act, the Province of New Brunswick maintains a database of groundwater quality data collected from domestic water wells drilled since 1994. 

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. 

IP-2.2.7(d). The strength reduction factor represents the reduction in yield strength with long-term exposure of the material to elevated temperatures and, in the absence of more applicable data, shall be taken as 1.0 for austenitic stainless steel and 0.8 for other materials. For castings, the basic allowable stress shall be multiplied by the casting quality factor, Ec. Where the allowable stress value exceeds two-thirds of yield strength at temperature, the allowable stress value must be reduced as specified in para. IP-2.2.7(c). Wind and earthquake forces need not be considered as acting concurrently. At temperatures warmer than 427°C (800°F), use 1.33... 

The guidelines also stress that the perfunctory execution of any quality system will not guarantee the production of data of adequate quality. The correct procedures for feedback, remedial action and staff motivation must also be documented and acted upon. In other words, there must be a genuine commitment to quality within a laboratory for an internal quality control programme to succeed, i.e. the IQC must be part of a complete quality management system. 

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. 

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