The Environmental Protection Agency (EPA) published its final ruling on the definition of ‘solid waste’ in the Federal Register Tuesday, in order to ensure the reclamation of manufacturing waste products are managed in a way that does not result in increased risk to human health and the environment from discarded hazardous secondary material.
The ruling includes an exclusion for manufacturers of 18 high-value solvents used across four industries – pharmaceuticals, basic organic chemical, plastics and resins, and paints and coatings – which will ensure byproducts are reused and not discarded, a ruling which was welcomed by the Society of Chemical Manufacturers and Affiliates (SOCMA).
“SOCMA is particularly pleased that EPA continues to recognize the very nature of our companies’ tolling relationships ensures their manufacturing byproducts are not ‘discarded—thus encouraging recycling,” the association said.
“While we would have liked to have seen EPA add a few solvents to the proposed rule, we still very much welcome this exclusion as it will remove the current regulatory disincentive to companies recycling the relevant chemicals.”
The EPA document admitted the management of solid waste in pharmaceutical solvent manufacturing was a “challenging area to address,” and involved “complex chemical processes already registered with the US Food and Drug Administration” (FDA).
“Some of these solvents are building block and primary intermediate chemicals, making them difficult to replace,” the EPA says. “Until lower-risk substitutes for these solvents are found, it is appropriate from a health risk standpoint to minimize the volume of solvents manufactured and to limit exposure to those already manufactured.”
Solvents are used for a number of functions in the pharma industry, whether providing molecules to build some drugs, used as a reagent, or used for extraction and purification.