Sufficient similarity

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Short description: Para-legal concept in the United States
Part of the 'sufficient similarity' doctrine, from EPA Guidelines for the Health Risk Assessment of Chemical Mixtures

Sufficient similarity is a 20th-century para-legal concept used in the chemical industry for toxicological studies.[1][2] The term was first employed in a restricted sense to assess surrogacy of chemical mixtures by the EPA, and has descended from there into the scientific argot.[2][3]

The concept is somewhat nebulous, and statistics are involved.[4] A group of America researchers in 2018 posed themselves the question how similar must a product be in order to be well-represented by the tested reference sample?[5] Because the concept was derived from the EPA, chemical similarity and biological similarity are equally important.[5] The concept is employed "so that safety data from the tested reference can be applied to untested materials,"[5] because "when toxicity data are not available for a chemical mixture of concern, US EPA guidelines allow risk assessment to be based on data for a surrogate mixture considered “sufficiently similar” in terms of chemical composition and component proportions."[1]

References

  1. 1.0 1.1 Stork, Leanna G.; Gennings, Chris; Carter, Walter H.; Teuschler, Linda K.; Carney, Edward W. (2008). "Empirical evaluation of sufficient similarity in dose—Response for environmental risk assessment of chemical mixtures". Journal of Agricultural, Biological, and Environmental Statistics 13 (3): 313–333. doi:10.1198/108571108X336304. 
  2. 2.0 2.1 Marshall, Scott; Gennings, Chris; Teuschler, Linda K.; Stork, Leanna G.; Tornero-Velez, Rogelio; Crofton, Kevin M.; Rice, Glenn E. (2013). "An Empirical Approach to Sufficient Similarity: Combining Exposure Data and Mixtures Toxicology Data". Risk Analysis 33 (9): 1582–1595. doi:10.1111/risa.12015. PMID 23398277. 
  3. EPA (1986), “Guidelines for the Health Risk Assessment of Chemical Mixtures”, Federal Register, 51(185), 34014–34025, Washington, DC: U.S. Environmental Protection Agency.
  4. Feder, Paul I.; Ma, Zhenxu J.; Bull, Richard J.; Teuschler, Linda K.; Rice, Glenn (2009). "Evaluating Sufficient Similarity for Drinking-Water Disinfection By-Product (DBP) Mixtures with Bootstrap Hypothesis Test Procedures". Journal of Toxicology and Environmental Health, Part A 72 (7): 494–504. doi:10.1080/15287390802608981. PMID 19267310. 
  5. 5.0 5.1 5.2 Catlin, Natasha R.; Collins, Bradley J.; Auerbach, Scott S.; Ferguson, Stephen S.; Harnly, James M.; Gennings, Chris; Waidyanatha, Suramya; Rice, Glenn E. et al. (2018). "How similar is similar enough? A sufficient similarity case study with Ginkgo biloba extract". Food and Chemical Toxicology 118: 328–339. doi:10.1016/j.fct.2018.05.013. PMID 29752982. 





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