Harmonic tests

OPPT has developed a series of test guidelines called the Harmonized Test Guidehnes. Eor health effects, the relevant guidelines are Series 870, Health Effects Test Guidelines. These guidelines are addressed in more detail in Chapter 4. The adopted test guidelines are listed in Table 2.7 and the draft test guidelines are listed in Table 2.8. 

US-EPA (OPPT) Harmonized Test Guidelines, Series 870, Health Effects Test Guidelines, Final Guidelines... 

The harmonized test guidelines have been developed for use in the testing of pesticides and toxic substances, and the development of test data that must be submitted to the US-EPA for review under Federal regulations. The OPPT guidelines are based on the OECD test guidelines (Section 2.2.6) however, minor deviations may occur. The guidelines are available for download at the OPPT Web site (US-EPA 2006d). 

The principles of GLP ensure the generation of high quality and reliable test data related to the safety of industrial chemicals, pesticides, pharmaceuticals, food and feed additives, cosmetics, veterinary drags as well as food additives, in the framework of harmonizing testing procedures for the mutual acceptance of data. 

As with drugs and purified biomarkers, thermal- and photostability of botanical products are the factors that must be considered. Commercial dried extract and capsules of SJW were evaluated under harmonized test conditions (25). Photostability testing showed all the constituents to be photosensitive in the tested conditions. However, different opacity agents and pigments influenced the stability of the constituents. Amber containers had little effect on the photostability of the investigated constituents. Long-term thermal stability testing showed a shelf life of less than four months for hyperforins and hypericins, even when ascorbic and citric acids were added to the formulation. 

Accordingly, public resistance and concerns among researchers increased the desire to harmonize test procedures and recommendation worldwide. With the creation of the International Conferences of Harmonization (ICH) these initiatives were channeled into a global process, which is ongoing. 

While data from internationally harmonized test methods are preferred, in practice, data from national methods may also be used where they are considered as equivalent. In general, it has been agreed that freshwater and marine species toxicity data can be considered as equivalent data and are preferably to be derived using OECD Test Guidelines or equivalent according to the principles of Good Laboratory Practices (GLP). Where such data are not available classification should be based on the best available data. 

The ICFI has recently (1994) promulgated harmonized testing guidelines for reproductive toxicity in five study designs adopted by the European Union, Japan, and the United States in 1996 (Figure 4). 

Each pharmacopeia has at least one identification test, with Japan having the most at five. The goal of the ICH is to eliminate these differences and harmonize testing so that there would be one set of agreed-upon tests, with the optimal and most efficient tests included. 

EPA (2008). OPPTS Harmonized Test Guidelines. Series 870 Health Effects Test Guidelines— Pinal Guidelines. http //www.epa.gov/opptsfrs/publications/OPPTS Harmonized/870 Health Effects ... 

Recently, Diard et al. studied the effects of electrochemical non-linearities on impedance measurements using an FRA. They derived theoretical expressions for the error in impedance measurements using the odd harmonic test criterion.Measurements of the fundamental and third... 

Different national and international institutions have established methods to assess the environmental risk of plant protection products. The EPPO (European and Mediterranean Plant Protection Organization) and the Council of Europe have worked to harmonize test methods for the environmental side-effects evaluation especially on bees. This work has led to the publication of a decision-making scheme for the environmental risk assessment of plant protection products [17] (Figure 3.1). This scheme is common to all the member countries in Europe, but the methods used are in fact determined by each country. 

An odd harmonic test [125, 580] was also proposed in the literature to check system linearity. 

EDANA, INDA, WSP (worldwide strategic partners) harmonized test methods, 2012. 

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