Kelly Sewell
SAN JOSE, CA — In an effort to ensure the US isn't at an economic disadvantage by having too many cleanroom standards in place, the US TAG to ISO/TC 209 sent a letter to the IEST last month requesting the IEST initiate replacement of the Fed-Std-209 as well as elevate the international standard (ISO 14644-1) to a standard in the US. The clincher is that IEST only gives recommendations to the General Services Administration (GSA), and doesn't have influence over the timing of when action can be taken on the TAG's requests.
The US Technical Advisory Group (TAG) approached the Institute of Environmental Sciences and Technology (IEST) because IEST is the organization designated by
the GSA to update/write the document for the US government. The US, through the Reagan Paperwork Reduction Act, no longer creates or updates standards.
The US TAG, which comprises representatives from non-profit and government organizations with an interest in contamination control, “is trying to ensure that the US doesn't have an economic disadvantage because it has so many standards,” says Anne Marie Dixon, head of delegation, US TAG to ISO/TC 209, who wrote the letter to Robert Mielke, vice president of the contamination control division at IEST, on the US TAG's behalf.
According to Dixon, the letter asks that Fed-Std-209 be replaced by ISO 14644-1 and -2 within six months of the publication of ISO 14644-2 because as a completed document set, 14644-1 and -2 offers sufficient cause to replace Fed-Std-209. Most other countries replaced theirs November 1, a date that is significant because it marks six months since 14644-1, “Classification of air cleanliness,” was issued as an ISO standard. The letter also asks that Fed-Std-209 not be used in any documentation written in the US from the date of replacement forward, Dixon says.
The request will be reviewed by IEST Working Group 100, which makes its recommendation to the IEST Executive Board, which then makes its recommendation to GSA.
The TAG hoped this review would take place at the WG-100 meeting scheduled for mid-November as part of the IEST Recommended Practices meeting. However, according to Mielke, this may or may not happen at the meeting. “It depends how many members will be at the meeting. We're trying to reconstitute the committee, which has been dormant for a number of years, and it's been a task to find people.” Mielke says when WG-100 votes on it, the working group will draft a letter to the GSA, whatever that vote is. “Whenever it takes place, once we give our recommendation to GSA, it's in their hands.”
For the US TAG to make a formal request of the IEST, “it's better that they do it this way than to continue the path they're on. Before, all they were doing was coming places like this show [CleanRooms West '99] and stating that Fed-Std-209E was dead, but there wasn't any momentum behind it. So now they've made the request formally,” says Bob Spector, president-elect of the IEST Executive Board.
While waiting for the GSA to act on the request to sunset 209E, the letter also requests that the IEST Executive Board immediately submit ISO 14644-1 to ANSI as an American National Standard. “This action can take place at the discretion of the IEST Executive Board, and should not be dependent on the outcome of GSA,” Dixon explains. Since the ANSI action is unrelated to GSA, theoretically, there could be a period of overlap if ANSI elevates 14644-1 to standard level before GSA sunsets Fed-Std-209, should that be what IEST recommends.
Richard Matthews, chairman of the International Organization for Standardization Technical Committee ISO/TC 209, “Cleanrooms and associated clean environments,” and Dixon, who presented an update of the ISO standards at CleanRooms West '99, outlined a “best case” scenario in which the ISO documents 14644-2 and -4 documents become Final Draft International Standards in November [the meeting had not yet taken place as of press time]. “Sixty days later, they'll be published by ISO and subject to the six-month mandatory expectation by ISO,” Matthews explains.
It is by this time that Dixon hopes IEST will have taken action to replace the US Fed-Std-209E. However, members of industry remain skeptical.
“The GSA has to sunset the document, and GSA cannot move that fast,” observes Ken Goldstein of Cleanroom Consultants Inc. (Scottsdale, AZ). “As soon as they get it, they'll send the document out and request consensus of all the federal agencies that are affected by it. If one of the agencies has a problem with it, that would cause further delay. I can't possibly see it taking any less than one year.”
 Dixon: Attempting to prevent US from being at economic disadvantage. |
But Charles W. Berndt of C.W. Berndt Associates Ltd. (Highland Park, IL), and a member of the CleanRooms Editorial Advisory Board, says that although the time frame is questionable, the transition to the ISO documents will happen. “The 209E standard will be sunsetted, there's no question about it. ISO is a better document; it's more flexible. But it won't happen in six months.”
ISO/TC 209’s first standard, 14644, comprises eight parts. The part-1 document is called “classification of air cleanliness,” while the part-2 is called, “Specifications for testing and monitoring to prove continued compliance with ISO 14644-1.”
TAG makeup
The US Technical Advisory Group for ISO/TC 209 comprises representatives from many US organizations. The TAG is responsible for making sure the US position is protected in regards to the ISO cleanroom document. It includes representation from such organizations as US Pharmacopeia, US Food and Drug Administration, Association for the Advancement of Medical Instrumentation, International Society for Pharmaceutical Engineering, American Society of Heating, Refrigerating and Air-Conditioning Engineers, SEMI, American Society for Quality, and Institute of Environmental Sciences and Technology, among others—all of whom have cleanroom activity, involvement or concern. — KS