Comment submitted by J. Rueppel

I would to comment on the issue of whether handlers of pharmaceutical waste should be required to maintain the pharmaceutical wastes in their original packaging if received as such. I believe that pharmaceutical waste handlers should be required to do so, for the following reasons: First of all, such wastes would be better protected when maintained in their original packaging. They will be less likely to leak out, with the potential consequences of contamination of the local water supply. Generally, the original packaging consists of some kind of plastic covering or otherwise fairly impenetrable substance. As well, this original packaging is unlikely to be recyclable, either because of pharmaceutical contamination, or because it is simply to small an amount of substance to be worthy of recycling effort. However, it may be quite feasible to recycle some portions of the original packaging, such as cardboard containers around the plastic covering. The cardboard boxes do not serve much of a protective function, and will not protect against water infiltration. Secondly, the removal of the original packaging may itself create risks of contamination for workers involved in such removal. It is important that such contamination/exposure not occur. Removal of the original packaging may not be feasible by machine. Also, I would like to comment upon the proposed rule's allowance for shipment of pharmaceutical wastes to foreign waste handlers. We have already seen that when wastes such as computers and electronics are shipped to 3rd world nations for recycling, the crude methods of recycling employed there often result in terrible health effects for the impoverished workers who choose recycling as their vocation. Pharmaceutical wastes shipped abroad also have many potential harmful effects. There may be attempts to resell/reuse such pharmaceutical wastes, even though they may be expired or otherwise contaminated after collection and shipment. The United States should ensure that all pharmaceutical wastes are handled safely and securely so that potential misuse and mishaps are prevented.