Secrets behind the mask
"Poor predictors." From its earliest days, the 8710's regulatory history is disturbing. In May 1972, it quickly won government certification. The standards, for one thing, did not require regulators to perform a crucial face-seal test. Regulators checked the 8710's filtering ability, but that test wasn't worth much, many experts say. The reason: Even if a mask passed the test, it didn't necessarily mean it was doing a good job. In testing, a mask became caked with contaminants, blocking flow through it. But until that caking took place, contaminants could enter.
Records and safety standards also suggest that regulators should never have granted approval because the mask could not be tested to ensure proper fit. Government standards in the 1970s were widely seen as obsolete, but they weren't updated until nearly a quarter of a century later.
Government approval was critical because without it, companies would have been reluctant to buy the 8710. In reality, however, the approval didn't represent much assurance. The agency's approvals, NIOSH Director J. Donald Millar wrote in a 1983 memo, "have frequently proved to be poor predictors of performance in the workplace."
3M publicly trumpeted the 8710's government certification in its advertising, but behind the scenes, the company was dismissive of such approvals. As a 3M executive said in an internal report: "It doesn't tell you anything" about effectiveness. Said another: "NIOSH approvals are a marketing device."
The story of the 8710 began long before the product ever won NIOSH approval. Early on, 3M developers traveled to the University of California's Los Alamos Scientific Laboratory in New Mexico, where they sought guidance from the lab's noted respirator expert, Edwin Hyatt. The results gave reason for pause. Lab tests showed that small, lethal particles penetrated the mask. The New Mexico researchers also didn't like that the 8710 came in only one size, because human facial features vary so widely. "Generally, our reports back to 3M were: 'This is really not a sound design, and it does not seem to be working very well,' " recalls Darell A. Bevis, who worked on Hyatt's team and later became a respirator consultant.
Those warnings were a sign of troubles to come. Indeed, the mask experienced serious problems for at least two decades, according to 3M and government documents. They included just about all areas--leakage, breathing resistance, collapsing on the face, manufacturing troubles, difficulties in monitoring quality, deterioration of the product after manufacture, problems with the one-size-fits-all approach, and trouble with the rubber straps that hold the respirator close to the face.
For at least several years beginning in the late 1970s, 3M's own testing showed that up to 100 percent of respirators examined failed one or more government standards, according to company records. Internal 3M documents disclose that the company conceded it couldn't measure up. As a 3M manager said in a 1975 internal report concerning one federal standard: "We . . . thoroughly examined the problem to determine if there was anything we could do technically" to comply. "The conclusion was that we could not." Patricia Gussey, a senior NIOSH official from the late 1970s, says that if she had known of the results, "there would be all kind of questions." One possibility, she says: revoking the 8710's certification. That very well might have torpedoed sales of the respirator.
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