By Rick Andrew
From time to time the question comes up, “Why isn’t there a standard for (fill in the blank)?” This is an interesting question, with a variety of possible answers. It could be that the issue, product type, or concern is so new or recent that there hasn’t been time to develop a standard. Another possibility might be that the product or issue is unique or confined in terms of market. Consensus standards development is not a small undertaking and requires a significant investment on the part of the standards developer. The market for any standard must be sufficient as to provide a reasonable return on investment. There is still a market need, however, to verify product safety and/or efficacy for new and unusual products, products with unique capabilities and innovative technologies. And there are several different approaches to fulfilling this need in addition to the traditional consensus standard development process. A potentially very attractive option is that of protocol development, testing and certification.
A ’lite‘ version of a standard
In many ways, protocols are similar to standards. They ultimately serve the same purpose – to help establish that products are suitable for a specific end use. In this regard, protocols typically include minimum requirements, scopes, test methods, and pass/fail criteria. There are some differences between protocols and standards, however. The key difference is the level of peer review and consensus required for adoption.
A consensus standard developed under the requirements of the American National Standards Institute (ANSI) requires input from all affected stakeholder groups. The mechanism typically used to achieve this objective is the Joint Committee – a group representing different constituencies brought together for the common purpose of developing standards. The size of the committee can exceed 30 people. There are highly specific voting procedures and requirements involved with these groups, involving review and consideration of any negative votes prior to moving forward.
A protocol, on the other hand, requires significantly less peer review. Because it is not a consensus standard, ANSI requirements for development do not need to be followed. A significantly smaller group can develop the protocol, with less formalized procedures for reaching consensus. See Protocols versus NSF/ANSI Consensus Standards for a summary of similarities and differences between protocols and standards.
The result of using a much smaller peer review group with less formalized consensus requirements is a faster and less expensive path toward finalization – a lite version of the very specific and formal process and requirements for developing an ANSI standard. The lower investment allows protocols to be developed for situations in which the market for certification may not justify development of a consensus standard.
Caution must be used to ensure the integrity of protocols. Because there is a smaller group developing the protocol using less rigorous procedures, moving faster, there could be risk that protocols might lack the due diligence or credibility of standards developed under a more formalized consensus process. This is where the expertise and experience of the protocol developer comes in. Those organizations firmly grounded in public health expertise, with extensive standards development history, are best positioned to capture all of the critical aspects of products to be evaluated and qualified through protocols to ensure suitability for a specific end use.
Ultimately, protocols can become standards. If protocol certifications expand to a considerable number of manufacturers, or if there are other relevant considerations, a formal Joint Committee may decide to take on the initiative of bringing a protocol through the consensus process to adopt it as a national standard. If this is accomplished, the protocol is retired and the ongoing certification is conducted under the requirements of the ensuing consensus standard.
Familiar POU/POE protocols
Some of you may be familiar with protocols through work in the POU/POE industry or through familiarity with consumer products. Protocols are typically designated with a ’P‘ followed by the protocol number, as opposed to consensus standards, which when developed by NSF carry the designation of NSF/ANSI followed by the standard number.
Some of the more familiar NSF protocols include:
- NSF P231 – Microbiological Water Purifiers
Probably the best known protocol among the POU/POE sector, this protocol establishes minimum requirements for health and sanitation characteristics of microbiological water purifiers. The requirements are based on the recommendations of the US EPA’s Task Force Report, Guide Standard and Protocol for Testing Microbiological Water Purifiers (1987) (Annex B). Manufacturers certified to this protocol include 3M Purification, Inc.; Everpure, LLC; Kinetico, Incorporated; Pentair Residential Filtration, LLC and Pentek.
- NSF P335 – Hygienic Commercial Hand Dryers
This Protocol establishes requirements for health and sanitation characteristics of hygienic commercial hand dryers which include air temperature and filtration, dry time (to ensure users’ hands are completely dry within 15 seconds), water disinfection and automatic operation. Other requirements of P335 relate to noise levels, burn resistance and product cleanability. Manufacturers certified to this protocol include Dyson, Ltd.
- NSF P172 – Sanitization Performance of Residential and Commercial, Family-Sized Clothes Washers
This Protocol evaluates the ability of washing machines with a sanitizing cycle to reduce microorganism concentrations on a small percentage of significantly contaminated clothing items in an otherwise typical laundry load. The protocol establishes the ability of washers to sanitize laundry under those conditions as well as confirm there is no significant carryover of contamination to subsequent laundry loads. Manufacturers certified to this protocol include Bosch Siemens Home Appliances Corporation; Electrolux; LG Appliances, Inc.; Samsung Electronics Co., Ltd. and Whirlpool Corporation.
Protocol certification similar to standards
Certification to a protocol is quite similar to certification to a consensus standard. The minimum requirements and test requirements must be met prior to certification. Like certification to a standard, certification marking is placed on the product to assure users of conformance. Web site listings serve as further evidence of certification to protocols, just as is done with standards. Additionally, production facility audits are conducted to ensure that products are manufactured using the same suppliers, materials and production methods as the product when it was evaluated for certification. Any potential changes to products potentially affecting certification must be reviewed and potentially tested prior to the changes being put into production.
Protocols serve an important purpose
Few would debate the relevance or importance of consensus standards. Consensus standards represent an approach that incorporates input from all affected stakeholders, thereby ensuring that all those with an interest in the outcome are heard when it comes to setting product requirements for suitability of purpose. It is time consuming and expensive, however, to develop consensus standards. The involvement of such a large and diverse group of technical experts results in a significant investment of time and expense to product the end result. For products with large markets, especially those significant in terms of impact on public health and safety, it is clear that this investment is well justified.
The justification for this level of substantial investment is less clear with respect to more niche products or unique innovations. The alternative of a protocol can be very appealing in these situations, due to the lower level of investment required. Additionally, protocols can be completed quickly, allowing new or novel technologies to be qualified for use in a shorter time frame. Care must be exercised to assure integrity and appropriateness of protocols, because the consensus process is not in place. Protocol developers with a long history of expertise in public health and product standards are key to an outcome of relevant, protective, reasonable protocols.
About the author
Rick Andrew is the General Manager of NSF’s Drinking Water Treatment Units (POU/POE), ERS (Protocols) and Biosafety Cabinetry Programs. He previously served as the Operations Manager, and prior to that, Technical Manager for the program. Andrew has a Bachelor’s Degree in chemistry and an MBA from the University of Michigan. He can be reached at (800) NSF-MARK or email: Andrew@nsf.org