On May 8, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNUR) for 25 chemical substances that were the subject of premanufacture notices (PMN). The SNURs require persons who intend to manufacture (including import) or process any of these 25 chemical substances for an activity that is designated in the SNUR as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The rule will be effective July 7, 2015.
The draft final rule includes SNURs for several biobased chemicals. The SNURs for fatty acids, satd. and unsatd alkyl-, esters with polyol (generic) (PMN Number P-13-139) and fatty acids reaction products with polyethylenepolyamine and naphthenic acids (generic) (PMN Numbers P-14-616 and P-14-617) limit uses of those substances to those in the PMNs, but that aquatic toxicity testing could demonstrate lower hazard and obviate the need for the SNUR. A SNUR for 1,2,3-propanetriol, homopolymer, dodecanoate (PMN Number P-14-395), which could be a biobased chemical, limits “use of the substance that results in releases to surface waters exceeding 18 ppb.” Again, aquatic toxicity testing could demonstrate lower hazard and lead to a higher concentration limit or obviate the need for the SNUR. These SNURs demonstrate what we have stated many times, namely that biobased chemicals are “renewable,” but not necessarily non-toxic. Esters are a category that triggers concerns according to EPA’s New Chemicals Program Chemical Categories report, so regulations to limit releases of these substances to water should not be a surprise. When submitting PMNs to EPA for new biobased chemicals, companies should keep in mind that robust pollution prevention statements can offset possible concerns by putting the new biobased substance in a risk context with incumbent technologies that it may replace. EPA can make a reduced risk determination and forgo regulation if it has sufficient information to substantiate the relative risk of the new substance and the incumbent it will displace.