Participation and transparency in standardssetting

Historically, both private and governmental standards-setting bodies have worked with scientific experts and businesses to construct standards. This approach has generated robust national and international standards regimes that have simultaneously advanced and protected proprietary interests while facilitating global commerce and trade. However, this approach is coming under increasing public scrutiny. First, the level and nature of risk that consumers and workers find acceptable may be different from that which businesses and experts consider appropriate. Second, the non-public nature of some standards development can create an impression of collusion and secrecy between industry, experts, and government that can undermine public confidence in standards and standards-setting bodies. Discussion centered on three interrelated themes, including whether and how: (1) public participation should be increased, (2) limits should be placed on such participation, and (3) standards-setting processes can be made more transparent.

Defining and operationalizing the concept of standards

To increase public participation in standards development and implementation, the concept of standards will first have to be defined and operationalized so that the participants are responding to the same basic idea. Key dimensions for clarification include:

• Standards vs. standardization. The terms "standards" and "standardization" refer to distinct concepts. For example, "standards" may be used either to standardize or to differentiate among products, processes, and procedures. Participants in standards-setting processes must be made aware of this distinction so they clearly understand the intended purposes, outcomes, and potential consequences of their participation.

• Formal vs. informal dimension. One dimension that must be clarified immediately is the degree of formality of the standards in question. For example, where along a continuum extending from legally binding restriction and technical proscription at the formal end to social convention at the informal end are such discussions to occur? Traditionally, the more formal standards dimensions provide less room for full public participation; conversely, social conventions are by nature negotiated through open and transparent public interaction.

• Public vs. private dimension. The same may be said of public versus private standards, where private standards are typically negotiated by less public or participatory means.

• Technical vs. strategic dimensions. The very concept of standards needs to be presented publicly as a socially negotiated and strategic phenomenon, rather than solely as the specification of technical attributes or criteria. Standards first need to be recognized as strategic devices that are negotiated among and reflect the interests of participating groups. Standards are thus simultaneously technical and social phenomena that both reflect and are responsive to the broader participation of potentially affected groups.

Defining and identifying potentially affected groups

The bigger questions involve how to identify who the potentially affected groups are, the preferred participatory processes once they have been identified, and clarifying the goals of the process. Some of the key questions that will have to be addressed up front in each of these areas include:

• Identification Are these demographic categories of people? Are they defined geographically, socially, culturally, by spheres of economic activity? Do they "self identify," or are they identified by others? And how do companies, private industries, etc., fit into this mix?

• Process Once potentially affected populations have been defined and identified, is their participation a function of attending formal standards-setting events, or is it incumbent upon standards-setting organizations to engage in outreach to obtain information from these groups? And in any of these cases, how does one know if one has been successful? The process of participation must be set to meet the expectations of those who are to participate in that process.

• Goals What are the standards for participation in standards-setting processes? What principles guide the process? What is the goal? "Better" decisions? Broader representation in decisionmaking, regardless of the quality of those decisions? Equitable distribution of impacts, costs, benefits? Greatest good for the greatest number of people? Economic efficiency? These things will need to be agreed upon, or if not agreed upon, then they will need to form the basis for public discourse. Workshop attendees identified numerous reasons to pursue public participation in standards-setting processes, including: (a) it is the right thing to do, (b) it fosters public trust in standards-setting, (c) it can lead to greater public protection from unforeseen risks given less participatory processes, and (d) it provides for greater public insight into regulation. The public may have questions that the regulators have not considered. Regulation is a long-term affair while public engagement is too often seen as something to be tacked on at the end of the process. At the same time we need to recognize that this can slow the regulatory process. One might want to engage in different forms of participation for different reasons. There is a need to be sensitive to culturally appropriate forms of participation. For example, experience conducting public participation among Amish and Native American communities, where collective decisions are often framed through the counsel of respected elders, suggests that "one person, one vote" models are not universally accepted, nor are random samples or statistical representation necessarily desirable (Stone, 2001).

• Incentives From a company perspective there has to be a competitive aspect. There needs to be a clear benefit for encouraging broad participation. If this cannot be established, then there is little incentive to do it. Then it comes down to being required, or forced to do so, and this is not always desirable in the absence of clear benefit. An economic basis for participation must be established. Is it going to be better than what the market would provide? How is this made clear?

Preferred models of participation

Many models exist for public participation and may be adapted in one way or another to meet the needs of participation in standards-setting processes as well as the expectations of the participants. The

International Association for Public Participation is a good repository of such information (www.iap.org). Models may range from highly centralized events, such as public hearings, to highly decentralized processes, such as community extension services. These may be highly facilitated/mediated or analytical/deliberative events. In mediated processes, participants resolve a dispute on their own without any "decision" being made by a chairperson or a judge. The resolution in mediation may incorporate agreements on legally irrelevant and often emotionally charged issues. Deliberative processes, on the other hand, are more legalistic or legislative in nature, and typically avoid legally irrelevant and emotionally charged issues. Some examples of successful models used in other contexts include the following:

• Nano Jury's "Mutualistic Engagement" model, builds upon the UK experience with its "GM Nation" effort and is presently being applied to public engagement around emerging nanotech-nologies (www.nanojury.org).

• The South Carolina Citizens' School of Nanotechnology is a model of engagement that is particularly well-adapted to public education on nanotechnology (nsts.nano.sc.edu).

• The USDA Cooperative State Research, Education, and Extension Service (CSREES) provides information concerning decentralized extension-based approaches to community outreach and education that are broadly applicable to public dialogues concerning nanotechnology standards (crees.usda.gov).

• The Risk Perception Mapping (RPM) model, developed primarily for social assessment in nuclear waste facility siting, is a decentralized and ethnographic approach that may work well in assessing the potential social impacts associated with siting nano-technology manufacturing facilities (Stoffle et al., 1991, 1993).

Less clear is how such models would work within standards-setting processes. One thing CODEX has done for international NGOs is to develop standards through electronic workshops rather than physical working groups. Perhaps a hybrid model mixing and matching various elements of these could be developed for specific standards-setting processes.

Public meetings are insufficient

Public meetings provide a venue where people can publicly express themselves, make impassioned pleas on behalf of their communities, demonstrate their commitment and dedication to and concern for their community's well-being, but they do not necessarily provide information regarding the distribution of concerns among a population. One cannot assume a speaker speaks for a community of interest, and the claims made at such meetings should not necessarily be considered public participation.

Drivers of information/insight gained through public participation

What are the drivers of the information being sought through public participation, and what insights are to be gained through such processes?

• Risk perception The social impacts literature suggests that such impacts occur to the extent that people perceive themselves to be at risk from something. Risk perception is an important driver in standards participation. For example, one might ask what risks and impacts do potentially affected groups associate with the phenomenon around which standards are being developed, and perhaps more importantly, what are the modes of risk impact.

• Risk perception analogs The public perceives risks of new technologies through experience with applications of earlier technologies. Illustrative examples are failures such as Chernobyl, Exxon Valdez, and Bhopal, where the concern was not with the technology per se, but rather with management of the technology. This introduces a new dimension to "risk identification" and management, extending it beyond purely technical considerations and into the realm of social experience with analogous technologies and projects. It also introduces issues surrounding public trust in the institutions charged with managing the risks associated with the technology, or with a specific project or application of it.

• Trust Bernard Barbers (1983) work on trust is instructive here. Barber links concepts of trust with public expectations about the future, specifically, (a) "the persistence and fulfillment of the natural and moral social orders," of (b) "technically competent role performance," and that (c) "partners in interaction will carry out their duties in certain situations to place others' interests before their own," what he calls "fiduciary responsibility." Public participation is often marked by a disjuncture among these expectations, particularly (b) and (c), where scientists and technical "experts" typically frame their risk discussions around assumptions and demonstrations of technical competency (e.g. "trust us because we are technically competent"), while potentially affected publics typically frame the issue in terms that include but extend beyond technical competency to encompass the "fiduciary responsibility" they see as inherent to risk management (e.g. "can this institution be trusted to place broader public interests above its own immediate concerns?"). As such, Barber's work is instructive concerning potential disjunctures in public participation in standards-making. How might these be integrated to build public trust in not only the standard itself, but the process through which it was developed, and indeed perhaps the technology itself?

In this sense, social experience with nuclear power, biotechnology, wireless communications, etc., will be helpful for understanding the kinds of risk perception analogs that will likely drive public participation around nanotechnology, including the development and implementation of standards in this area. This may not generate "better" standards per se as much as a range of "different" standards, niche standards that respond to the values and expectations of distinct communities of interest.

Risk communication

Although education is important to an informed public dialogue on nanotechnology, the participatory issue should not exclusively be about technical understanding but equally about social understanding of how a person and her or his social network stands to be affected. Decision-makers (standards-setters) must remain open to being educated by participants about the social contexts of their concerns—contexts that ultimately will have to be addressed in the standards that are promulgated. Risk communication is a two-way street and must occur early in the process to help frame social contexts of risk perception. This will help clarify the preferred subjects of risk assessments and socially appropriate risk management options for decision-makers. Standards-setting processes have to be collaborative, and participation is a vehicle for that. Otherwise, one has the old linear model of experts deciding what counts and the public reacting to their decisions. The key will be translating the processes used into socially responsive policies and standards—if that is the goal. The International Risk Governance Council is a good example of an organization that deals with such issues, and it has recently released a white paper on nanotechnology risk governance that is informative for public participation in nanotechnology standards development (IRGC, 2007).

Limits of/to participation

There should be procedural but not substantive limits to participation. Some of the key issues to be considered include:

• Proprietary interests of participants These must somehow be protected. Multiple layers of proprietary interests are likely to influence the process. Moreover, transparency itself may actually be seen as a disincentive to participate, particularly if transparency means that trade secrets or other proprietary information could be publicly revealed. This is a timing issue: done too early in the process could have the opposite of the desired effect. Then the process is likely to be seen as dishonest rather than transparent.

• Human subjects There is a need for full disclosure of purpose and use of information obtained through participation. In addition, there must be assurances that data will be used in only certain ways. Some key questions that must be addressed are: How can this be ensured? Who is responsible for situations where such disclosures are violated? How are disputes arising from this to be adjudicated?

• Saturation, co-optation, and accountability There is a need for streamlining among all the many stakeholder organizations and potentially affected groups. Participation can be costly and time-consuming. In the US it tends to be industry representatives who have the financial support to attend these events. If there are 30 meetings a year, which are the ones most worth attending, in terms of both affordability and ability to influence outcomes? Answering this question presumes that one can anticipate outcomes. Yet, one cannot know whether a specific meeting is the one in which it is most worth participating. The participation "market" can quickly become saturated, with no clear direction about to whom to turn or toward what ends the process will lead. For example, the interests being served will likely be reflective of the interests of those who coordinate and implement the event. The perception that one group's interests can be co-opted by another's is a potential disincentive to participation. It creates a cynical perception of the process and ultimately of the decisions reached. Yet, someone has to make these decisions, and not every interest will be equally served. This raises related issues regarding those interests consistently underserved in standards-setting processes.

• Scale—local to international Scale presents another potential limit to participation—not everyone can or perhaps even should participate. Can local input be scaled up to national and international dialogues, and vice versa? This could become quite daunting and the complexity itself could serve as a disincentive to scaling up participation.

• Equity and social justice At some point decisions must be made. One has to have milestones for progress in decision-making, and yet at the same time there are many publics that are difficult to reach. Equity issues may be sacrificed for the sake of expediency. Simple "majority rules" solutions may not adequately address equity, particularly in instances where the "minority" views are consistently discounted. There is a need to protect minority perspectives from a "tyranny of the masses," a social justice dimension that should not be overlooked, but often is. In this sense, current limits on participation may actually have to be expanded in order to allow for greater discussion of equity and social justice. But determining who will make that call, and on what grounds, is the subject of broad public dialogue. Key questions in this area include: (a) how equity issues can be addressed procedurally, and (b) whether participants are willing to accept outcomes or decisions that they might consider inappropriate. This condition will have to be understood by all parties going into the process. Otherwise the process will unravel and simply become the domain of a self-selected subset of interests. This cannot legitimately be called "participation."

Toward greater transparency in standards-setting processes

In standards-setting, no open-source mechanisms exist in which the public can clearly see the process and is welcome to be part of it. This would assume an educated public, at least to some degree, so a truly open-source mechanism could only be implemented upon the shoulders of a broader public education mechanism. However, as noted previously, public education is a two-way communications issue in which the point is not just to educate the public on the technical aspects of standards issues, but to be educated by them concerning the social contexts of their concerns.

• Formative evaluation Formative evaluation can help to increase transparency in standards-setting processes. Key evaluation questions concern: (a) establishing a clear definition or understanding of "transparency," specifically its goals and procedural objectives, and (b) how one knows when these have been met. The answers to these questions will likely vary by stakeholder interest, so this dialogue needs to occur independently of the standards-setting process. Answers to these questions will help to establish appropriate models of participation that can then be pursued to maximize transparency as so defined. This should be an iterative or formative process in which outcomes inform the implementation of future processes, that is, in terms of the definitions, goals, and procedural objectives of both transparency and the participatory procedures used to obtain it.

• Educating the public on nanotechnology The South Carolina Citizens' School of Nanotechnology provides a good example of educating the public about nanotechnology generally, but turnout has been quite low to date. Also, it is unclear how representative of broader publics such techniques actually are, or whether they have even been conceived to address representational issues. Clear representation in educational programs is important— determining who speaks for whom, and how (or whether) each voice in the process can be weighted. The South Carolina program team is presently revising the Citizens' School process to explicitly address these issues.

• Educating decision-makers on social context National representatives to Codex and other groups have a responsibility to collect information from their respective publics. But there are no consistent procedures whereby national organizations are expected to interact with them. The information is inconsistent, and there is little guidance regarding how that information will actually be used to help shape standards decisions. A recent report of a joint workshop of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) indicated that in such cases there must be room for minority opinions and decision-makers must be accountable for why such opinions may not be factored into the decisions reached (FAO/WHO, 2004). In the UK, Defra (Department of Environment, Food, and Rural Affairs) has utilized focus group models to increase public accessibility to nanotechnology discussions, and this could be adapted to increase transparency of nanotechnology standards deliberations, or at least public understanding of how these processes work (www.defra.gov.uk). A public advisory board could work as intermediary between the formal standards-setting process and the multitude of voices that could potentially demand a formal role in the process. The interaction between the advisory board and the public would be very transparent. The board would then take that information to the standards committee. Someone still has to make decisions, though, and the public is left largely to react rather than collaborate on the decisions reached.

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