Implications, exemption

Haber was slow to grasp the implications of the Nazis rise to power. As Germans boycotted Jewish businesses and Hitler s brownshirts removed Jewish students from university libraries and laboratories, the Nazis passed a law on April 7, 1933, to cleanse the civil service and universities of Jews. By this time, Haber s Kaiser Wilhelm Institute was financed by the government and its employees were treated as civil functionaries subject to the new law. Haber himself was exempt because of war work and seniority. Eager for a chemical warfare center, Nazi authorities singled out Haber s institute and ordered him to fire its Jews. At the same time, the Kaiser Wilhelm Society told Haber to somehow keep his important senior scientists. He had until May 2 to act. 

I have included in today s presentation three of these issues first, the distinction between a "new" and a "naturally occurring" chemical substances for the purpose of the applicability of the premanufacture notification (PMN) requirement of TSCA second, the scope of the research and development exemption from the PMN requirements, and its implication for open field testing of microorganisms and third the type and amount of information that EPA might need for risk/benefit analyses of new microorganisms. I will also briefly mention some technical areas in which further research would greatly facilitate the processes of risk/benefit assessment. 

In Canada, polymers are defined under the CEPA in the same manner as they are in the EU and under the polymer exemption in the US, but the regulatory implications are different. In Canada, all types of new polymers (those not present on the DSL) must be notified (unless manufactured or imported in certain small quantities), unlike the general exemption in the EU or the specific polymer exemption in the US. As mentioned previously, meeting the polymer definition in Canada allows the substance to be notified as a polymer and not a chemical, which reduces the amount of test data and other information that must be submitted. Therefore, it is critical that a substance be carefully analysed, particularly for molecular weight distribution, so that its notification in Canada as a polymer is validated. 

The Carra Letter went on to address the implications of making a yarn treatment product before it is added to the yarn to which it will provide antistatic properties. If a salt form of antistatic agent is made by pH neutralization of an acid precursor during the formulation process of making the yarn treatment product, then the salt does provide a primary purpose of the yarn treatment product, and it is not exempt from the Inventory and PMN regulations. This is the case even if other yarn treatment ingredients are present in the formulation when the acid precursor is neutralized. The distinction between this example and the polymer salt example is that the polymer salts were made as part of the ink formulation and do not contribute a primary performance characteristic of ink, but in this example the acid is made as part of a product that is intended only as a yarn treatment and it does contribute one of the primary performance characteristics of the yarn treatment product. 

---