The Respirator Box With the Wrong Approval Number
Why this case is worth reading
A respirator is the one part in a field-service shop whose whole performance is invisible. A counterfeit breaker can be weighed and a counterfeit refrigerant shows up on a gauge, but a filtering facepiece that lets dust through looks, fits and feels exactly like one that does not. The only test available to a shop is paper: the approval number, checked against the agency that issued it. This case is about what happened when that check failed, and it is told in the order the shop acted, because the right move was to stop using the stock before anyone knew why the number was wrong.
The approval check itself is owned by a sibling; How to Verify a Respirator Is NIOSH-Approved.
The lookup that did not match
A nine-person remodeling and repair shop bought 20 boxes of 20 N95 filtering facepiece respirators, 400 in all, from an online marketplace seller at roughly half what its usual safety distributor charged for the same model. The box named the same approval holder and model the crew had been fit-tested on the year before. The facepieces had headbands rather than ear loops, the word NIOSH spelled correctly, a filter class of N95 and an approval number in the form TC-84A- followed by four digits, printed on every facepiece. They passed every visual check anyone thought to do.
Two weeks later the shop's new office manager, setting up a reorder, looked the approval number up in NIOSH's Certified Equipment List, the agency's searchable list of every approved respirator. The number existed, but it belonged to a different approval holder and to a valved respirator, not the unvalved model on the box. Nothing under the approval holder's own name matched the model either.
Contain first, before knowing why
There were four possible explanations, and three of them were innocent. The shop did not wait to find out which, because the cost of being wrong ran in one direction. If the stock was genuine and the lookup was a mix-up, pulling it for a day cost a day of inconvenience. If the stock was not genuine, every hour it stayed on trucks was an hour of crew members breathing through a filter with no known performance. So the owner did three things that afternoon.
Stop use. A text to every tech: do not wear the new boxes, starting now, and bring every one back. The text named the box's lot number so nobody had to guess which boxes.
Pull and count. By the next morning the office had 18 sealed boxes (360 respirators) plus 6 loose unused ones from two trucks. The job records showed 34 worn and discarded. 360 plus 6 plus 34 is 400, so every unit was accounted for. The 366 unused ones went into quarantine under one tag; see related: The Suspect Counterfeit Quarantine SOP.
Replace from the known channel, and the same model. The shop's safety distributor delivered the model the crew had been fit-tested on, from the approval holder's authorized channel, the next morning. The model mattered. Under OSHA's respiratory protection standard, 29 CFR 1910.134(f)(2), which applies to construction work through 29 CFR 1926.103, an employee must be fit-tested again whenever a different respirator facepiece (size, style, model or make) is used. Replacing the stock with a different model, however good, would have meant no required-use respirator work for anyone until each wearer was fit-tested on the new one. Buying the same model kept the existing fit tests valid and the crew working.
Interim exposure control. Two jobs scheduled that week involved cutting concrete block indoors with a handheld saw. The owner moved those cuts outdoors, with the saw's water delivery running and each cutter under 4 hours of cutting per shift, a combination for which the silica standard's Table 1 row requires no respirator, until the replacement stock arrived.
The four explanations, eliminated
A transcription error. The office manager may have typed the number wrong. She re-read it from three separate facepieces and two boxes; all five matched what she had typed, and the list still showed the other company's valved respirator. Eliminated.
A legitimate private label. NIOSH approvals are held by an approval holder, and the same approved respirator can be sold under another company's name as a private label, which the Certified Equipment List shows under the approval holder's entry. The name printed on this box did not appear as a private label under that approval number or anywhere else on the list. Eliminated.
A rescinded approval. NIOSH can revoke or rescind an approval, after which old stock carrying that number is no longer approved. That would have explained a number that did not match a current entry, but this number was current; it simply belonged to a different product. Eliminated.
Misrepresentation. NIOSH maintains a public page of respirators it has found misrepresenting a NIOSH approval, with photos of the product and its markings. The product on the shop's boxes was on it, with the same packaging and the same borrowed approval number. That was the answer.
The order matters for any shop that repeats this check. The first two explanations are the common ones and take five minutes to rule out; the NIOSH counterfeit page settles the last. A shop that jumps straight to "it's fake" will sometimes be wrong about a private label, and a shop that assumes "probably a typo" will sometimes keep handing out unapproved respirators.
Why every visual check passed
It is worth being exact about what the shop did check, because it was more than most shops do. NIOSH's published warning signs for a counterfeit filtering facepiece include no markings on the facepiece itself, no approval number on the facepiece or headband, NIOSH misspelled, decorative fabric or add-ons, claims of approval for children, and ear loops instead of headbands. These facepieces had none of those. They carried the markings an approved N95 is expected to carry: the approval holder's name, the approval number, the filter class, the model and a lot number, all printed on the facepiece.
That is the lesson the shop banked. Every one of those markings is ink, and ink costs a counterfeiter nothing. The warning signs catch careless fakes; a careful one copies a real product's markings and borrows a real approval number, as this one did. The only check a copied marking cannot pass is the lookup that asks the issuing agency whether that number belongs to this product, which is why the lookup has to name the approval holder, the model and the style together and not just confirm that the number exists. A number that exists is what a borrowed number looks like.
The price and the channel were the two signals present from the start. Half the distributor's price on a product whose cost is mostly the filter media and the approval holder's quality system is not a bargain the market usually offers. See related: The Price That Is Too Good.
The question the containment did not answer
Stopping use protected everyone going forward. It did not answer what happened in the two weeks before. The 34 worn respirators had been used on two kinds of work, and they differ under the rules.
Voluntary use. About 20 had been worn sweeping up dust in attics and on cleanup where no respirator was required. Under 1910.134(c)(2), voluntary use of a filtering facepiece needs only that the employer provide the information in Appendix D and make sure the respirator itself creates no hazard. The shop logged these, gave the wearers the facts, and closed them.
Required use. About 14 had been worn cutting concrete block indoors with a handheld saw on three basement jobs, by two technicians. The construction silica standard, 29 CFR 1926.1153, lets an employer skip exposure assessment for a task by fully and properly implementing the controls in its Table 1, and the Table 1 row for handheld power saws used indoors or in an enclosed area calls for water delivery plus a respirator with an assigned protection factor of at least 10, whatever the duration. A properly fit-tested, NIOSH-approved N95 filtering facepiece has an assigned protection factor of 10 under 1910.134(d)(3)(i)(A). A respirator without a valid approval has no assigned protection factor at all. So on those three jobs the shop had not fully implemented Table 1, and the standard's fallback is to assess the exposure the task produces.
The shop ran that assessment for the indoor cutting task under its existing procedure (see related: The Exposure Assessment SOP), with the hygienist sampling a technician doing the same cut on the replacement respirators. The two technicians were told in writing what had happened, which jobs, and what the assessment found. Assessing a past exposure that cannot be re-measured is an industrial hygienist's call, and the shop handed it to one rather than guessing.
The supplier, the report and the change
The shop wrote to the marketplace seller with the lot number, photos of the box and facepiece, and screenshots of the Certified Equipment List entry and the NIOSH counterfeit listing, and asked for a refund and the seller's source. The refund came; the source did not. The owner reported the listing to the marketplace and sent NIOSH the details through the contact on its counterfeit page, and logged both.
Two changes followed. Respirators moved onto the shop's safety-critical purchasing list, bought only through the approval holder's authorized distributors (see related: The Safety-Critical Parts Purchasing SOP). And every new respirator lot now gets its approval number looked up against the Certified Equipment List when it is received, before the boxes reach a truck, with the lookup result written on the receiving log. The office manager's check, the one that found this, was done by accident during a reorder. It is now a step.
References
- OSHA 29 CFR 1910.134, Respiratory Protection, including (c)(2) and Appendix D (voluntary use), (d)(3)(i)(A) (assigned protection factors) and (f)(2) (fit testing on a different facepiece); applied to construction by 29 CFR 1926.103
- OSHA 29 CFR 1926.1153, Respirable Crystalline Silica (construction), Table 1
- NIOSH Certified Equipment List and NIOSH guidance on counterfeit respirators and misrepresentation of NIOSH approval
- See related: How to Verify a Respirator Is NIOSH-Approved
- See related: The Exposure Assessment SOP