Transcript for the OSHA Training Video Entitled
Counterfeit & Altered Respirators:
The Importance of Checking for NIOSH Certification
This video provides a brief overview and general information about counterfeit and altered respirators and the importance of making sure that a respirator is certified by the National Institute for Occupational Safety and Health, also known as NIOSH. Employers are responsible for selecting appropriate respirators for their workers, and this video will assist them in making such a selection. This information is also good for both workers and their employers to understand the potential consequences of counterfeit and altered respirators.
The Occupational Safety and Health Administration, also known as OSHA, permits only NIOSH-certified respirators to be used to protect workers. The issue of counterfeit and altered respirators is of increasing concern to NIOSH and OSHA. Counterfeit respirators are products that are falsely marketed and sold as being NIOSH-certified and may not be capable of providing appropriate respiratory protection to workers. Altered respirators are non-approved modifications to a NIOSH-certified respirator. These modifications include using replacement parts that are not original manufacturer parts or modifying a certified respirator in a non-approved manner.
The use of either counterfeit or altered respirators can jeopardize worker health and safety because there is no way of knowing whether these products or parts meet the stringent testing and quality assurance requirements of NIOSH and will provide workers with the expected level of protection. These products are usually priced lower than certified respirators in order to appeal to cost-conscious employers.
If respirators are required to be worn, OSHA's respiratory protection standard requires employers to develop a comprehensive respiratory protection program. This program must include many topics, such as but not limited to: respirator selection, cleaning, storage, fit testing, medical evaluations, and worksite-specific training.
Knowing when and how to wear the appropriate respiratory protection is an important line of defense against exposure to respiratory hazards. Employers are responsible for selecting appropriate respirators for their workers.
Employers and workers need to know that the respirators used in their workplace are tested and certified. Workers' lives may depend on it.
The best way to check that a respirator is NIOSH-certified is to look for the NIOSH name or logo. They may be found on the respirator's packaging, user instruction insert, and/or on the respirator itself. A respirator cannot legally display such markings unless it has met NIOSH's stringent testing and quality assurance requirements.
The following information pertains to all types of respirators including filtering facepiece, elastomeric, powered air-purifying, and atmosphere-supplying respirators. However, for demonstration purposes, let's look at N95 particulate filtering facepiece respirators - the most commonly used respirators. These respirators are often referred to simply as "N95s." In this type of respirator, the facepiece is actually made of filter material. When properly fitted and used, N95s filter out at least 95% of the most-penetrating particle size, but are not resistant to oil.
If a respirator has been NIOSH-certified, it will have the following markings on the respirator's packaging, user instruction insert, and/or on the respirator itself:
- The NIOSH name or logo;
- The NIOSH filter classification - in this case "N95";
- The NIOSH test and certification - or TC - approval number;
- The Approval Holder's business name (usually the manufacturer), registered trademark, or an easily understood abbreviation;
- The model or part number; and
- The manufacturing lot number.
Checking for these markings is the first step in verifying that a respirator meets NIOSH requirements. If your respirator doesn't have the appropriate markings, do not use it in a hazardous atmosphere and notify your supervisor or respirator program administrator immediately.
Employers should be aware of three serious respirator issues when selecting and purchasing respirators for their workplace - counterfeit respirators, misleading advertising, and approved respirators that have been altered or modified.
There are respirators being advertised and sold in the marketplace as NIOSH-certified or as N95s that are neither NIOSH-certified nor meet the NIOSH N95s performance criteria.
There are a number of reasons these respirators enter the workplace. The most common is price. These respirators are often lower priced than certified respirators in order to appeal to cost-conscious employers. Another reason is lack of availability. Counterfeit respirators may enter the workplace when the regular supplier is unable to ship or supply NIOSH-certified products regularly used at a facility. For example, this happened during the 2009 pandemic flu outbreak, when N95s were in short supply.
There are products that are labeled "NIOSH" or "N95," but which have never been submitted for NIOSH testing by the manufacturer.
For example, when this product was brought to the attention of NIOSH, it was tested as part of the investigation and did not pass NIOSH's stringent requirements.
It's just one of many counterfeit N95 products on the market.
This product was sold by a major retailer as a NIOSH-certified N95 respirator. NIOSH investigators determined that this product had originally failed NIOSH testing and had been repackaged and then sold under a different name while still claiming to be NIOSH-certified.
Some respirators claim to provide protection against specific infectious agents, such as advertising that they provide Avian and Swine Flu protection. However, NIOSH doesn't test or certify respirators for protection against specific diseases.
While some respirator models may have an added antimicrobial treatment on the filter, the effectiveness of these treatments is not evaluated by NIOSH. Products that make claims about protection against specific infectious agents having these treatments must be cleared by the U.S. Food and Drug Administration, also known as FDA.
In addition, there are products that were once certified by NIOSH but have since had their certification revoked. NIOSH continually monitors the products it certifies, as well as the quality control programs of the manufacturers, and revokes the respirator certification when necessary.
In this case, the manufacturer failed to maintain an acceptable quality control plan. NIOSH revoked 14 of the manufacturer's respirator certifications, and these products can no longer be manufactured or distributed as NIOSH-certified. Continuing to sell these respirators as if they were still NIOSH-certified is another example of misleading advertising.
Employers also need to be aware of and avoid purchasing certified respirators that have been altered or modified. Such products are often legitimate certified models with unauthorized after-market decorations or other changes to make them "fashionable."
NIOSH certification only applies to a respirator as it was originally tested. Even the slightest modification to a certified respirator may affect its fit, form or function, thereby voiding its NIOSH certification.
This N95 respirator was tested in its original form and received NIOSH certification.
Another company modified the certified respirator by covering it with a decorative fabric. The attachment of this additional material can adversely affect the filter's performance, making it less effective. Additional material can also make breathing more difficult, and could possibly cause carbon dioxide from the wearer's exhaled breath to build up in the respirator.
Since the respirator was modified its NIOSH certification is no longer valid.
In another instance, this modified respirator was featured in an in-flight magazine ad and falsely advertised as "FDA cleared and NIOSH approved."
Another problem is when users themselves alter respirators to enhance their comfort or appearance, not realizing that they have voided the NIOSH certification and may have compromised their own safety. This may affect the integrity of the respirator and the protection it provides.
In this case, decorative pins created holes in the mask, increasing the possibility of hazardous particles penetrating the filter.
Never alter a respirator. Doing so can reduce its protective quality and expose the user to the airborne hazard. Never glue or staple things to a respirator; or write on a respirator's filter material; and never put holes in a respirator.
Another problem involving altered respirators is the use of counterfeit replacement parts. It is important to only use approved replacement parts because NIOSH tests all the individual components as part of the system to assure that they function properly and meet stringent quality control requirements. Many approved replacement parts have the manufacturer's logo or part numbers stamped or etched into the part. Another way to tell is whether or not the replacement part comes packaged in the original equipment manufacturer's packaging or if you have gotten the parts from a reputable supplier or distributer.
If employers purchase counterfeit parts, there's no way to know if they will function properly. The use of counterfeit replacement parts such as non-original hoses, facepiece lenses, and cylinders voids the respirator's NIOSH certification, violates the OSHA regulation, and may jeopardize worker health and safety. The counterfeit replacement parts may not provide the necessary air flow requirements or may not fit properly and allow leakage.
How can you and your employer know that the respirator you depend on to protect you has undergone the rigorous NIOSH certification process and is genuinely NIOSH-certified?
The answer may be as close as your computer. Visit this website and with a few clicks of a mouse, you can:
- Verify which respirators are NIOSH-certified;
- Review the User Instructions;
- Access Respirator User Notices;
- Get answers to frequently asked questions about respirators; and
- Download publications on virtually every aspect of respirators, including their use and care.
If a respirator has certification markings but is not in the NIOSH Certified Equipment List, it's likely to be either a counterfeit or a respirator that has had its certification revoked. If there is no TC number on the respirator's packaging, or on the user instruction insert, or on the respirator itself, it's not NIOSH-certified. Additionally, if the information in NIOSH's Certified Equipment List database does not match the information associated with your respirator, it's not NIOSH-certified and may be a counterfeit respirator.
To be certain that a respirator not on the list is either
a counterfeit or revoked by NIOSH, call this number.
For more information about respirator use in your workplace, refer to these NIOSH and OSHA websites.
States with OSHA-approved State Plans may have additional
requirements for respiratory protection. To get more information on state-specific
standards within State Plan states, please visit these websites or call
your state's On-Site Consultation Office.