Re: Regulation

["Sandy Perle" <sandyfl@ix.netcom.com>]

>2)Inspectors in the UK now have powers, after a visit, to 
     (i)   advise on recommended improvements (ALARP)
     (ii) if ignored, issue Improvement warnings, and
    (iii) if all else fails, issue Prohibition notices, stopping
    particular practices.<

This is quite different from regulatory inspections in the U.S. I 
also see where this type of an inspection can be quite serious, for 
many reasons. These are just a few of my observations:

1. What background does the average inspector have?
2. Does a facility generally get inspected by an individual who is 
    cognizant of the facility business that is being inspected?
3. To allow an inspector to make recommendations that potentially 
    have a "prohibition notice, stopping particular practices" is 
    quite drastic. What recourse does a facility have to argue 
    against a recommendation they feel quite strongly against?
4. A recommendation seems to be very similar to our Regulatory 
    Guides, Information Notices, etc. The primary difference is that 
    they are just that, recommendations, unless they are commited to 
    by the facility.
5. By giving equal weight to recommendations as are given to 
    regulations is a dangerous thing. While we may not agree with the 
    current regulations, at least we know they are regulations. Seems 
    that an inspector can promote their own agendas with their 
    recommendations.

So, what safeguards are there in the event of a "runaway" inspector?

Sandy Perle
Director, Technical Operations
ICN Dosimetry Division
Office: (800) 548-5100 Ext. 2306 
Fax: (714) 668-3149

E-Mail: sandyfl@ix.netcom.com    

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