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Keywords:

  • environmental health and safety (EHS);
  • environmental policy;
  • industrial ecology;
  • nanomaterials;
  • risks;
  • survey

Summary

  1. Top of page
  2. Summary
  3. Introduction
  4. Methodology
  5. Results
  6. Discussion
  7. References
  8. About the Authors

Voluntary initiatives by industry have been frequently proposed as one of the most promising ways to reduce potential negative impacts on human health and the environment from nanomaterials. In this study, we examined the industrial perceptions, internal procedures, and performance of the nanomaterial industry. We conducted a written survey of 40 companies in Switzerland and Germany. Most companies replied that nanoparticulate materials (NPMs) should be subject to some kind of regulation, but industry did not convey a clear opinion as to who should be responsible for managing the potential environmental health impacts or how to regulate NPMs throughout their life cycle. If NPM risks were to be identified, most of the companies surveyed do not have standardized procedures for changing production technology, substituting inputs, redesigning processes, or reformulating final products to reduce or eliminate risks of NPMs. However, a majority of the survey respondents found their existing routines regarding these procedures to be sufficient.


Introduction

  1. Top of page
  2. Summary
  3. Introduction
  4. Methodology
  5. Results
  6. Discussion
  7. References
  8. About the Authors

There are many products containing nanoparticulate materials (NPMs) on the market today, and there are expectations for more applications, ranging from lightweight materials, drug-delivery systems, and catalytic converters to food, cosmetics, and leisure products. However, NPMs possess unique properties that may have toxic potential and implications for their environmental fate (Oberdörster et al. 2005; Hardmann 2006; Helland et al. 2007; Koehler et al. 2007).1 Therefore, various stakeholders have called for action to ensure the safety of NPM production and products with regard to the workplace, the consumer, and the environment.

Industry is the key player in the design and manufacture of products and is increasingly exploring cleaner production and pollution prevention approaches, such as process designs, final product reformation, and raw material substitutions (van Berkel et al. 1997; Gasafi et al. 2004). Skeptics question whether such voluntary practices by industry should be replaced by legislation (Heaton and Banks 1997; Harrison 1998; Lifset and Lindhqvist 2001). One might argue that success depends on the extent to which such practices are implemented systematically within industry, industry's capacity for improving these practices, and industry's own perspectives on issues such as regulation and responsibility. These factors may implicitly reflect a company's willingness, opportunity, and capability to change, which contribute to the environmental health and safety (EHS) performance in firms (Ashford and Zwetsloot 2000).

In an earlier study, we discovered that European industry finds regulatory interventions regarding NPMs useful as long as they are evidence-based and voluntary in nature, and European regulatory bodies do not believe nanomaterials should be regulated until more scientific evidence indicates that they may be harmful (Helland et al. 2006). Regulatory bodies in both the United States and the United Kingdom have initiated public consultations on voluntary initiatives (DEFRA 2006; U.S. EPA 2007). Industry is also partnering with research organizations in EHS research projects, such as the EU-funded project NanoSafe2 (Nanosafe 2007), or with federal ministries, such as the German NanoCare project (BMBF 2006). In a complementary study with the same respondents as in this study, we explored the properties of NPMs produced by German and Swiss companies and industry's procedures for assessing the risks associated with these properties (Helland et al. 2008). Sixty-five percent of the companies surveyed had no structured approach for assessing the risks of NPMs. Further analyses failed to identify any factors that could explain when a company would conduct a risk assessment and when it would not. In a survey conducted by the International Council on Nanotechnology, the most frequently mentioned impediment to effective health and safety programs was lack of useful information and consistent guidelines (ICON 2006). In particular, larger companies mentioned this impediment, whereas smaller companies frequently identified cost concerns as important barriers to health and safety management.

Against this backdrop, the objectives of this study are to investigate how the German and Swiss NPM industry perceives precaution, responsibility, and regulation; manages the risk of NPMs; and assesses its own risk management performance. We explore whether the perceptions expressed by industry can be confirmed in companies' daily operational management, thus creating a basis for discussion on the need for regulation in this field. We present the survey method, the results of the survey, and the implications of the results.

Methodology

  1. Top of page
  2. Summary
  3. Introduction
  4. Methodology
  5. Results
  6. Discussion
  7. References
  8. About the Authors

To investigate how firms deal with the risks of NPMs, we conducted a written survey. Other aspects of this survey related to NPM properties and risk assessment procedures have been previously reported (Siegrist, Wiek, et al. 2007; Helland et al. 2008). The data were collected in Germany and Switzerland between December 2005 and February 2006. The sample consisted of a total of 135 companies, 48 from Switzerland and 87 from Germany. The companies were identified through Web sites, literature reviews, and personal contacts. Prerequisites for selection were that a company produces NPMs or an NPM-based product and that the NPM have at least one dimension of 100 nanometers (nm) or smaller, according to the general size definition of NPMs (U.S. EPA 2007). Before sending out the questionnaire, we contacted each company by phone and requested the person in charge of risk assessment procedures. If there was no such person, we contacted the person in charge of nanomaterials instead. A total of 40 companies, 20 Swiss and 20 German, filled out the questionnaire, which represents a response rate of 29.6%.

Thirty-eight percent of the companies were in the chemicals and materials sector, and 33% were in the consumer goods sector. The most common application fields for NPMs within these industrial sectors were coating and thin films for different materials (e.g., glass, wood, and textiles), medical applications, and electronic products. Twenty-five companies had fewer than 100 employees, 8 companies had between 100 and 1,000 employees, 6 companies had more than 1,000 employees, and 1 company did not answer this question. Fourteen companies reported that they were primary producers of NPMs, 21 companies were downstream users who purchased NPMs and used them in their applications, 2 companies produced and purchased NPMs for their applications, and 3 companies did not answer this question.

We developed a number of questions (Qs) to help address the objectives defined above (see table 1). Q1–3 addressed the industrial perceptions regarding precaution, responsibility, and regulation. Q1 explored the industrial interpretations of the precautionary principle operationalized through statements. Q2 and Q3 addressed life cycle responsibility and regulation. Q4–7 addressed selected industrial procedures, and Q8 discussed the industry's own assessment of these respective procedures and areas.

Table 1.  Overview of survey questions
  1. Note: Q = question; P = part.

Industrial perceptions
 Q1. Please rate your agreement with the following statements:
  P1: Measures should be taken even if the evidence of the extent of the risk is not yet conclusive.
  P2: Emissions should be kept as low as reasonably achievable regardless of the known or unknown effect on the environment or human health.
  P3: Measures should be taken if specific criteria of potential irreversibility (e.g., persistence) are fulfilled. Specific characteristics serve as warning signs.
  P4: The proposing actor should have to demonstrate that the planned activity or release of a substance will not harm the environment or human health.
 Q2. In the various stages of the life cycle, who should take responsibility for the potential impacts on human health and environment?
 Q3. How should the handling of nanoparticulate materials be regulated during the life cycle?
Industrial procedures
 Q4. If risk assessment reveals a lack of knowledge and there is a possibility of harmful effects, does your company have standardized criteria or procedures for
  a. raw material substitution?
  b. final product reformation?
  c. process change?
 Q5. Does the company promote research to reduce uncertainty regarding the potential risks of nano products?
 Q6. Does the company have procedures that involve different stakeholder concerns in product development?
 Q7. With which of these organizations does your company share risk related knowledge?
  a. What kind of knowledge is shared?
Industrial performance
 Q8. How would you assess the achievements of your company in the following areas?
  a. Raw material substitution
  b. Final product reformation
  c. Process change
  d. Best available information acquisition
  e. Promotion of risk research
  f. Inclusion of stakeholder concerns in product development
  g. Risk knowledge-sharing
  h. Risk assessment methodology

Results

  1. Top of page
  2. Summary
  3. Introduction
  4. Methodology
  5. Results
  6. Discussion
  7. References
  8. About the Authors

Industrial Perceptions

This section deals with industry's perceptions regarding precaution, responsibility, and regulation. Q1 had four parts (Ps), in which respondents ranked their level of agreement with statements related to the precautionary principle. Figure 1 summarizes these responses. There were originally five response categories (−2, −1, 0, 1, 2), ranging from strongly disagree to strongly agree, given in the questionnaire. Here, the results are summarized in three categories (disagree, neutral, agree) for better readability. Respondents were divided as to whether measures should be taken without conclusive evidence regarding NPM risks (P1). A majority of the respondents agreed that emissions should be kept as low as reasonably achievable (ALARA; P2) and that measures should be taken if specific criteria of potential irreversibility—for example, substance persistency—are fulfilled (P3). Finally, no majority opinion was found regarding whether the burden of proof should be on the company producing or using the NPM (P4). A principle-components analysis found that one factor explained 88% of the total variance, indicating that the respondents answered all questions in a consistent manner. The four interpretations were, in other words, highly correlated.

image

Figure 1. Respondents' interpretations of the precautionary principle (Question 1).

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Respondents' opinions on who should take responsibility for the potential impacts on human health and the environment during the product life cycle are provided in figure 2. During production, 36 respondents thought industry should be responsible, and 2 thought this responsibility should be shared between industry and government. During use, 24 respondents thought industry should be responsible, 4 thought government should be responsible, 4 thought the consumer should be responsible, and 4 thought this responsibility should be shared between government and the consumer. At end of life, the respondents' opinions were more divided: Seventeen respondents thought industry should be responsible, 3 thought the consumer should be responsible, 7 thought government should be responsible, and 9 thought this responsibility should be shared between government and the consumer. In summary, the respondents tended to externalize responsibility as the product moved further from production.

image

Figure 2. Respondents' opinions on who should take responsibility for the potential impacts on human health and environment throughout the life cycle (Question 2).

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Respondents' opinions on how NPMs should be regulated throughout the product life cycle are provided in figure 3. Nineteen respondents did not think regulations are needed during research and development, 17 thought industrial standards should be established, and 2 respondents thought governmental standards are needed. A majority of the respondents thought NPMs should be regulated by industrial standards during production, whereas the respondents were divided as to how to best regulate usage and end of life. Eighteen respondents thought NPMs should be regulated via industrial standards during usage, and 12 thought they should be regulated via governmental regulations. Fourteen respondents thought NPMs should be regulated via industrial standards at end of life, and 15 thought they should be regulated via governmental regulations. In general, industry is divided as to whether industrial standards or governmental regulations are the most appropriate form of NPM regulation.

image

Figure 3. Respondents' opinions on how nanoparticulate material (NPM) handling should be regulated throughout the life cycle (Question 3).

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Industrial Procedures

This section focuses on the internal procedures companies have for managing the risks of NPMs (table 2). When risk assessment reveals a lack of knowledge and a possibility of harmful effects, 3 companies had standardized procedures for addressing the risk through raw material substitution, 2 had procedures for final product reformation, and 5 had procedures for process change. Four companies had two or all three procedures in place. Two companies identified other procedures for addressing risk; 1 identified ISO 14000 procedures, and the other did not provide details. The majority, 21 companies, did not identify any standardized procedures for responding to a risk assessment that reveals a lack of knowledge and a possibility of harmful effects. It is interesting that 13 of those with no standardized procedures also disagreed with the first interpretation of the precautionary principle (P1).

Table 2.  Responses to questions about internal procedures (Questions 4–7)
  1. Note: Q = question.

Q4: If risk assessment reveals a lack of knowledge and there is a possibility of harmful effects, does your company have standardized criteria or procedures?Yes, for raw material substitution (3)
Yes, for final product reformation (2)
Yes, for process change (5)
Yes, for end product and process change (2)
Yes, for all three procedures (2)
Yes, other (2)
No (21)
Missing (3)
Q5: Does the company promote research to reduce uncertainty regarding the potential risks of nano products?Yes, internal research (3)
Yes, university collaborations (5)
Yes, internal and external research (6)
No (21)
Missing (2)
Q6: Does the company have procedures that involve different stakeholder concerns in product development?Participatory procedures (e.g., public consultations or hearings) (8)
Scenario analysis (6)
Other instruments: Network (1)
No (22)
Missing (3)
Q7: With which of these organizations does your company share risk-related knowledge?Other companies (24)
Universities (28)
Nongovernmental organizations (2)
Governmental institutions (18)
No knowledge sharing with other organizations (3)
Q7a: What kind of knowledge is shared?Toxicological/exposure data (15)
Safety knowledge (29)
Knowledge about risk assessment (7)
Other (e.g., technical knowledge (5)

Eleven of the companies promoted risk research. Fifteen of the companies had procedures for considering stakeholder concerns during product development: Eight employed participatory procedures, such as public consultations or hearings; six employed scenario analysis; and one respondent specified “network” under “other procedures.” A majority of the responding companies did not promote risk research or involve stakeholder concerns in their product development activities. Most companies, however, were involved in a network that shared risk-related knowledge, mainly knowledge about safety, toxicology, or exposure (see table 2).

Industrial Performance

Table 3 summarizes how respondents assessed their company's performance related to the industrial procedures discussed in Q4–Q7. In general, respondents were quite satisfied with their company's current performance. All respondents thought that acquisition of the best available information was important, although the routines used for it could be improved. The highest number of respondents saw room for improvement in promoting risk research; sharing knowledge with other organizations, such as safety knowledge; and determining risk assessment methodology. Most respondents were satisfied with their company's performance in raw material substitution, final product reformation, process change, and best available information acquisition. Respondents were divided on the importance of including stakeholders during product development. Those who thought stakeholder involvement is important were further divided on whether their company's process for including stakeholders was sufficient or needed improvement.

Table 3.  Responses to questions about industrial performance (Question 8)
ProcedureNot importantSufficientRoom for improvementMissing
  1. Note: Q = question.

Q8a: Raw material substitution 823 54
Q8b: Final product reformation 522 85
Q8c: Process change 327 64
Q8d: Best available information acquisition 022153
Q8e: Promotion of risk research1112143
Q8f: Inclusion of stakeholder concerns in product development14 9143
Q8g: Risk knowledge-sharing 413203
Q8h: Risk assessment methodology 9 9193

Discussion

  1. Top of page
  2. Summary
  3. Introduction
  4. Methodology
  5. Results
  6. Discussion
  7. References
  8. About the Authors

Companies perceive themselves as clearly responsible for potential impacts to human health and environment in the research, development, and production stages, but this responsibility is gradually externalized to other stakeholders throughout the product life cycle. This clear acknowledgement of industrial responsibility is in sharp contrast to a less uniform perception of regulation: Respondents' opinions varied as to whether industrial standards or governmental regulations should be established to regulate NPM handling during the each life cycle stage. Respondents' opinions were divided between industrial standards and no regulations during research and development, most thought that production should be regulated via industrial standards, and their opinions were divided between industrial standards and governmental regulations during use and at end of life.

The combination of industry's externalization of responsibility and regulations throughout the life cycle may be problematic, as current regulations generally do not cover NPMs. Thus, we may have a vacuum in corporate and public policy for ensuring that NPMs are developed and used in a safe manner. In an agent network analysis conducted in Switzerland, approximately 85% of the participants perceived government agencies as being completely responsible for environmental safety throughout the NPM life cycle, but only one of four regulatory bodies regarded itself as completely responsible (Wiek et al. 2007). Furthermore, approximately 60% of the participants perceived industry as being completely responsible for risk assessment, but only four of ten industrial participants perceived themselves as completely responsible for risk assessment. This leads to an important question: What should regulators do when industry does not convey a clear opinion on responsibility and regulatory action, although most industry members think some type of regulation is needed? In our opinion, this depends on whether industry takes sufficient voluntary initiatives for preventive strategies.

Precaution in Practice

We postulated in the introduction that the success of voluntary industry initiatives may depend on the extent to which preventive procedures are systematically implemented within industry, the industry's capacity to improve these practices, and industry's own perspectives on issues such as regulation and responsibility. In an earlier study, we found that 65% of Swiss and German companies producing or using NPMs did not conduct risk assessment and could not identify a systematic approach for assessing NPM risks, and we thus questioned whether the level of risk assessment initiatives within a company depends on the company's safety culture (Helland et al. 2008). The safety performance of a company is influenced by the willingness, opportunity, and capability to change, which are influenced by management and organizational, technological, and behavioral factors (Ashford and Zwetsloot 2000).

Preventing harm arising from production or products by eliminating problems at the source may involve changes in production technology, input substitution, process redesign and reengineering, and final product design and reformulation. About two thirds of the companies surveyed did not have such procedures in place, but most respondents assessed their existing routines for performing these procedures to be sufficient. This may imply that there are few or no incentives for considering alternative technology options, and thus a business-as-usual approach is chosen. One exception was the procedure of risk assessment. Although most of the companies surveyed did not have risk assessment procedures in place, many respondents expressed a desire to improve their performance, which indicates that companies need assistance in this area. The lack of established risk assessment and management frameworks for NPMs is problematic for the companies producing and using NPMs (Reijnders 2006; Davis 2007).

One challenge relates to the difficulties of agreeing on common nomenclature and standards. Initiatives to overcome these difficulties are in progress, however. The American National Standards Institute (ANSI) established the ANSI Nanotechnology Standards Panel (ANSI-NSP) in 2004 to coordinate the development of voluntary, consensus standards for nanotechnology applications, and in June 2005, the International Standards Organization launched ISO/TC 229, a technical committee on nanotechnology that oversees the development of standards for nanotechnologies, including classification, terminology and nomenclature, metrology, characterization, calibration, and EHS issues (ANSI 2007).

Awareness among key actors in a company (managers, engineers, researchers, safety experts, product designers, etc.) is heavily influenced by social factors such as communication and cooperation with other stakeholders, in addition to the existing corporate culture and core values (Ashford and Zwetsloot 2000). Increasing awareness among companies' key actors through training and outreach activities can improve a company's safety culture. The surrounding network of agents may therefore provide important contributions to industry for governing risks, but, nonetheless, greater industry contributions to the public knowledge on NPMs have been called for (Helland and Kastenholz 2007; Wiek et al. 2007). We may conclude from our results that most companies have an established network through which risk information is exchanged. This information exchange usually takes place among companies and between companies and universities. Nonetheless, the extent to which risk information is also transferred from companies to universities (e.g., through the funding of external research) is not clear. Most respondents think that improvements in information exchange are needed.

Another result of insufficient communication with external stakeholders may be related to consumer response. Nanotechnology experts may not be inclined to initiate the risk assessment expected by the public, as they perceive fewer risks associated with nanotechnology than laypeople do (Siegrist, Keller, et al. 2007; Siegrist, Wiek, et al. 2007).2 Although a high share of respondents claimed to include stakeholder concerns during product development, most did not have procedures in place for engaging stakeholders, and many did not find stakeholder involvement important. This may impede the entrance of some products into the market. Conversely, 14 respondents indicated a desire to improve their stakeholder engagement procedures.

Push, Hold, or Pull?

Do the companies have to be pushed or pulled to improve their precautionary measures, or is the current situation satisfactory? In the case of NPMs, industry believes that regulation should be evidence-based (Helland et al. 2006), but the fate of NPMs throughout the life cycle receives little industry attention (Helland et al. 2008). Thus, we must ask whether current scientific evidence warrants regulatory action. Industry's opinion on this is not clear. Two unifying opinions expressed in this study stand out: Emissions should be kept as low as possible, and specific characteristics of irreversibility are reason enough for taking precautionary measures. Industry does not necessarily see monitoring and demonstrating such characteristics as its responsibility, however. Building on the consensus opinion of the respondents, one may draw two specific questions of high priority for government–industry collaboration:

  • • 
    What are the possible sources of NPM emissions throughout the product life cycle, how high are such emissions, and what is the environmental fate of such emissions?
  • • 
    What NPM characteristics indicate potential irreversibility for ecosystemic interactions (e.g., persistency, bioaccumulation), and which NPMs specifically inhibit such characteristics?

On the basis of this study, we are not convinced that the current level of voluntary initiatives will be sufficient. Although most applications may be quite safe, there is still the concern that consumers may be exposed to unassessed risks. Developing proactive risk management strategies appears to be an urgent task for regulators and industry to minimize the risk of harm to the environment and the public health.

Notes

References

  1. Top of page
  2. Summary
  3. Introduction
  4. Methodology
  5. Results
  6. Discussion
  7. References
  8. About the Authors

About the Authors

  1. Top of page
  2. Summary
  3. Introduction
  4. Methodology
  5. Results
  6. Discussion
  7. References
  8. About the Authors

Aasgeir Helland was a researcher at the Technology and Society Lab, Empa, Switzerland. He is now working as an environmental officer at Think Global AS, an electric car producer in Oslo, Norway. Hans Kastenholz is a senior scientist at the Technology and Society Lab and lecturer at the Swiss Federal Institute of Technology (ETH) in Zurich, Switzerland. Michael Siegrist is a professor at ETH Zurich, Institute for Environmental Decisions (IED), Consumer Behavior, Zurich, Switzerland.