Monday, June 1, 2009

Pharmaceuticals and IST

Many people have complained in recent years about the decline in the civility of political discourse. One of the reasons that this has gotten so bad is that too many political discussions resort to hyperbole and exaggeration to make their point.

A perfect case in point is a recent article that I found n the SOCMA (new name - Society of Chemical Manufacturers and Affiliates) that claims that new chemical security legislation will have negative consequences for “consumers of pharmaceuticals”. The article states that “SOCMA speculates [emphasis added] that the substitution provisions” will result in American chemical companies becoming “barred from manufacturing chemicals” that are necessary to make drugs.

One presumes that that the ‘substitution provisions’ are the inherently safer technology (IST) provisions that organizations like Greenpeace and the Center for American Progress have been calling for. Now I have not seen the draft version of the legislation still being ironed out between the staffs of the Homeland Security Committee and the Energy and Commerce Committee. Neither apparently has anyone from SOCMA or else they wouldn’t be ‘speculating’ about the provisions of the bill and their consequences. To jump to the outrageous conclusion that the bill might include provisions that would prohibit the manufacture of pharmaceuticals or their intermediates is the worst sort of political polemic.

HR 5577 IST Limitations 

If the provisions of last year’s HR 5577 are any guide (and that is what Greenpeace and CAP have been actively and publicly promoting) the IST portions of the legislation will be directed at only the most hazardous chemical facilities. Even then, there are two very specific provisions that would stop such legislation from prohibiting the manufacture of pharmaceuticals or their intermediates. The Secretary {in Section 2110(b)(1) of HR 5577} could only order IST implementation if the facility conducted assessment of the alternative manufacturing procedures showed that the change:
(B) “can feasibly be incorporated into the operation of the covered chemical facility;” and
(C) “would not significantly and demonstrably impair the ability of the owner or operator of the covered chemical facility to continue the business of the facility at a location within the United States.”
Given that changes to the manufacturing of pharmaceuticals and their immediate intermediates is closely controlled by the FDA and any changes in the manufacturing process have to undergo extensive trials and testing, it is unlikely that any manufacturing of these chemicals would be changed by security regulations.

I fully understand why any chemical company would be reluctant to have DHS make any decisions about their manufacturing processes. While there are many fine people working at DHS, they are not (with the possible rare exception) chemical engineers or chemists. Even those personnel with the requisite training are unlikely to be familiar enough with the processes at any given facility to adequately judge what changes can safely be made to a particular chemical process.

Politics Favoring IST

More importantly though, SOCMA and the chemical industry as a whole must realize that a few facilities, Bayer CropScience outside of Institute, WV is the most recent example, have so damaged the reputation of the chemical industry that there are large portions of the population that do not believe that the chemical industry can be trusted to do what is right or safe.

There may be entirely reasonable explanations why large quantities of extremely hazardous chemicals (like methyl isocyanate- MIC, or chlorine, or anhydrous ammonia) must be stored near populated areas, but fewer and fewer people are willing to trust a large chemical company’s explanations, especially when those explanations consist of: “It is safe. We know. Trust us”.

If SOCMA, or anyone else in the chemical industry wants to prevent ‘bureaucrats’ at DHS from having unreasonable control over their manufacturing processes they need to start working with Congress and Greenpeace/CAP to come up with a reasonable outside review procedure for chemical manufacturing processes that contain significant quantities TIH chemicals. Otherwise it is likely that the ‘uneducated and unwashed’ will dictate procedures to the chemical industry. Not 'procedures that will drive the manufacture of pharmaceuticals off shore', but procedures that will be a paperwork problem for legitimate chemical manufacturers.

HR 2477 Dead

One last point; HR 2477 is a political dead end. Nobody needs to waste anytime in supporting this bill. However well intentioned the bill may be (and I have high respect for Congressman Dent’s intention in submitting this bill), anyone with any experience at watching congressional politics will recognize that the Democratic leadership has no intention of this bill ever coming to a floor vote. If it had any possible chance, it would have been referred to the House Homeland Security Committee, a committee to which the author and both co-sponsors belong. Without a positive report from the Homeland Security Committee, this bill will never get to the floor.

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