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Spray June 2016

June 2016 Spray 27 ical properties of chemicals, seven of which come with links. Using data from these sources is particularly advised, because if your data is ever challenged in an audit, you can point to the Hazard Classification Guidance document as having endorsed the source. Health Effects Data (Page 17-18): Similarly, the document lists 18 different sources for health effects data, 11 of which contain online links. The preamble, however, is the most important part, as it would suggest a hierarchy of data sources: If your company is manufacturing a new chemical you may be required to submit pre-manufacturing health effects data to the U.S. Environmental Protection Agency (EPA) to comply with the Toxic Substances Control Act (TSCA). Data submitted to EPA by other companies may be available to you by contacting EPA. This data may be used to assist with hazard classification and the preparation of SDSs and labels. The company also should seek toxicity data from the literature, government or private sources. The very first source of data on the list of 18 is “Company-sponsored research, if available” implying (but not outright stating) the primacy of this data source. On the other hand…OSHA also recently released a draft copy of a document, Guidance on Data Evaluation for Weight of Evidence Determination (available at: https://www.osha.gov/weightofevidence/woe_guidance.pdf) that directly addresses the issue of how the available evidence should be used in the process of classification: Weight of evidence, as used in the Hazard Communication Standard (HCS), means that “all available information bearing on the determination of toxicity is considered together,” including in vitro tests, relevant data from experimental animals, and data from humans. The identification of study evidence should employ standardized search strategies and reporting formats with clearly stated inclusion/exclusion criteria. Both positive and negative results are assembled together and the quality and consistency of the data are evaluated in order to make a judgment on classification. However, as discussed in Section 2.4, a single positive test that is performed according to good scientific principles, and with statistically and biologically significant positive results, may justify classification.” (Emphasis added by the author) Does this mean that a classifier can always just rely on a single positive data point, so long as it is “performed according to good scientific principles”? Section 2.4 makes it clear that the answer is No: The HCS states that, in some cases, a single positive study, performed according to established scientific principles and with statistically or biologically significant positive results may justify classification. However, the decision-making process must also take into account any other available data. Positive human evidence is not required for a positive hazard determination; positive animal studies should not be discounted without a strong scientific rationale for doing so. Expect these “Weight of Evidence” issues concerning classification to be the subject of much debate in 2016. This summary only scratches the surface when it comes to these two OSHA documents. Reviewing them must be priority one for anyone involved in chemical product compliance in the U.S. SPRAY


Spray June 2016
To see the actual publication please follow the link above