Have you ever looked at the tag on your power supply and wondered what all those symbols meant? Many of them represent a voluntary consensus standard designed to protect the safety and health of the user.
Since we believe these types of standards can serve a valuable purpose, we wanted to explain why and how we make the decision to participate – and why we and other NGOs recently withdrew from one such effort by NSF International, funded by the Grocery Manufacturers Association (GMA).
Put simply, a voluntary consensus standard means a relevant and balanced group of stakeholders got together and reached agreement on how to do something voluntarily and consistently that serves national needs.
For example, NSF/ANSI Standard 61: Drinking Water System Components sets health effects criteria for many water system components such as pipes and faucets. Such standards, overseen by the American National Standards Institute (ANSI), can create assurance that might otherwise require regulation.
As you’ll read below, the ANSI due process guidance for consensus standards require balance in the range of viewpoints considered. EDF increasingly finds itself invited to represent the public interest point of view.
Criteria for Participation
EDF will generally participate if (1) the standard is designed to solve a meaningful health, safety or sustainability problem, and (2) the process is likely to result in a standard that is truly a consensus.
Voluntary consensus standards are typically designed to advance important business objectives, which may not always be aligned with EDF’s goals. When asked to participate in standard development, we consider the following:
- Are the anticipated scope of the standard and problem(s) to be addressed clearly defined?
- Does the standard tackle a problem that EDF has identified as important? A process designed to institutionalize the status quo or that blocks needed regulations with an unenforceable alternative are not acceptable.
- Participation means investing in solving the problem. Do we have the expertise and capacity to take on the issue?
[Tweet “Consensus product standards can protect – or hurt – consumers. Learn how here:”]NSF sought to develop a new standard to guide how safety determinations on food additives should be made so they qualify for an exemption in the Food and Drug Administration (FDA) regulations, and asked EDF to participate. The exemption deals with substances that are “Generally Recognized as Safe” (GRAS).
Currently, FDA has interpreted the law to mean FDA’s approval or review of chemicals used as food ingredients, food contact substances, or to process food is not required. This lack of oversight is a controversial issue, and one EDF has prioritized for action.
Process is Paramount
Even if the substance of the proposed standard is important, EDF may find that the process to develop that standard is unlikely to result in a true consensus of all stakeholders.
The ANSI guidance on essential due process requirements is a useful tool for assessing the fairness of a standard development process. If both the spirit and substance of the guidance are followed, we are much more likely to see the process as fair. Key elements include:
- Openness: All persons directly and materially affected by the standard must be able to participate. EDF’s is only one perspective. Just as the business community is diverse, so is the community that promotes health, safety, environmental protection, and sustainability. EDF can’t represent all of those perspectives. If the process starts with a draft standard already developed and vetted by one interest group, we question the openness to changes.
- Lack of dominance: No single interest category, individual or organization dominates. ANSI generally limits organizations to one member. We pay special attention to the source of funding and potential conflicts of interest of the participants.
- Balance: The members have a balance of interests. For health and safety standards, this means members of the public interest or regulatory communities represent about one-third of voting members. If the federal regulatory agency that manages the issue under discussion does not participate as a member or active observer, we interpret this as a lack of confidence in the process.
- Coordination and harmonization: The organization that is managing the process and the chair must have a positive track record on managing a true consensus process.
- Notification: The draft documents need to be publicly available for comment. For EDF, this means the publication drafts are broadly disseminated in public fora accessible to all stakeholders at no charge. A charge for the final document is not uncommon.
- Consideration of views and objections: Concerns raised by voting members, observers and public commenters deserve full consideration and a written response.
There are no bright lines. Good faith efforts can be poorly initiated. Sometimes corrections can be made and the process salvaged, sometimes not.
In the case of NSF and GRAS, we did not see how the process could align with the ANSI guidance, and as a result, we withdrew.
To be clear, voluntary consensus standards can help institutionalize positive change. However, when EDF sees a standard that purports to be a ‘consensus’ yet held only to the form and not the substance of ANSI’s due process requirements, we may actively discourage that standard’s use by business. That’s what public interest groups do – look out for the public, including the business community.
We hope clarifying EDF’s approach can be useful to those considering the development of such standards.
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