Feedback from ACC

American Chemistry Council, Nanotechnology Panel

Posted on: March 30, 2007

Dear Scott and Terry:

The Nanotechnology Panel (Panel) of the American Chemistry Council is pleased to respond your request to submit comments on the draft Environmental Defense/DuPont document entitled “A Framework for Responsible Nanotechnology” (Framework). The Panel, which is composed of companies engaged in the production, distribution and/or use of chemicals with business interests in the products and applications of nanotechnology, supports and promotes the safe use and manufacture of the products of nanotechnology.1 (DuPont is a Panel member but did not participate in the preparation of these comments.)

General Comments

The Panel commends the Environmental Defense (ED) and DuPont Nano partnership for the preparation of the Framework document and believes that the Framework is a significant contribution towards ensuring the responsible development and safe use of nanoscale materials. Importantly, the Framework builds upon existing and well-established risk assessment processes and principles that are currently extensively relied upon and practiced within the business community. The Framework incorporates the disciplined, flexible approach that is common in many product stewardship programs, including the American Chemistry Council’s Responsible Care® program.

The Panel wishes to emphasize that while the Framework is comprehensive by design, application of the Framework by any given organization for one of more nanoscale materials will likely involve a series of specific risk assessment and management decisions on datasets, testing, hazard profiles, life cycle considerations, risk communication, risk mitigation and other factors. The Panel acknowledges that this important point is noted in Framework’s Executive Summary, but encourages ED and DuPont to emphasize this point in the Framework document itself. The Panel also urges ED and DuPont to revise the Framework so that it specifically addresses considerations and business circumstances unique to Small and Medium Sized Enterprises (SMEs). The Panel urges ED and DuPont to solicit comments specifically from SMEs before the Framework is written. While the Panel recognizes that ED and DuPont have gone to great lengths to obtain comment from all interested parties by facilitating a webbased comment submission mechanism, the Panel nonetheless believes that focused, separate efforts may be needed to obtain comments from the SME community and urges ED and DuPont to expend this effort. The forthcoming 2007 NanoBusiness Alliance meeting in New York City on April 15-17 may provide an excellent opportunity for ED and DuPont to emphasize the need for comment from SMEs on the Framework document.

Additionally, the Panel offers as a general comment that the Framework be revised to emphasize that where professional judgment is used in the absence of data, that the decision to do so be clearly documented and justified. This will ensure that when data are available, the decision to use actual data instead of assumptions will be facilitated.

Scope of the Framework

In considering the potential impact on SMEs, the Framework states in the second paragraph on page 2 that knowledge of the potential impacts on human health of nanoscale materials lags significantly behind the technical ability to manipulate and incorporate nanoscale materials into products. The Panel notes that in research and development (R&D) applications, scientists will focus on the possible benefits of a new material before focusing on potential EHS impacts. Some more evident EHS impacts will be assessed early in the R&D stage, but for less obvious impacts, such as those that may be associated with certain engineered nanoscale materials, the evaluation is likely to be conducted at a later stage of product development. The Panel is concerned that the Framework may appear overly burdensome, such that innovators and related decision makers in the engineered nanoscale material community may be discouraged by the potential burden of conducting all the steps in the Framework and the subsequent costs of doing so. The Panel urges ED and DuPont to revise the Framework to emphasize that the goal of the Framework is to facilitate the responsible development of nanotechnology.

The Framework supports the use of “reasonable worst case” values and/or assumptions for the evaluation of risk in the absence of sufficient hazard or exposure data. It should be noted that in cases where this approach is applied and the results show no potential for an adverse effect, collecting more data or conducting additional assessment should not be necessary. Furthermore, the Panel appreciates the importance of using conservative assumptions for risk characterization purposes; the Panel also believes that it is important that the framework explicitly state that use of these assumptions may well overestimate risk. The Panel believes that when there is uncertainty in estimates of risk, the presentation of a single estimate of risk could be misleading and offer a false sense of precision in characterizing risk. By presenting a range of plausible risk estimates, along with a central estimate, risk assessors often convey a more objective characterization of the magnitude of potential risks. Influential risk assessments often characterize uncertainty by highlighting central estimates as well as high-end and low-end estimates of risk.

The Framework Dataset Should Reflect Product-Specific Attributes, Cost Information, Alternatives to Animal Testing, and Alignment with OECD Testing Guidelines

The Framework advocates the use of base datasets for the characterization and assessment of nanoscale materials. The Panel supports the collection of appropriate hazard identification information for all nanoscale materials, regardless of whether substances are considered new or existing materials for Toxic Substances Control Act (TSCA) Inventory purposes. Data collection for hazard identification, however, should follow a tiered approach that expressly considers the volume, end use, and potential exposure scenarios associated with a particular material. Professional judgments should form the basis of decisions regarding what qualifies as an adequate amount of hazard and exposure data that is considered adequate for evaluation purposes. The Panel emphasizes that not all nanoscale materials will require the same amount of hazard and exposure information to conduct a scientifically appropriate evaluation.

Each material will need to be evaluated on a case-by-case basis, taking into consideration the material’s specific physical properties, end uses, and potential for human and environmental exposures. The generation of complete base datasets may not, therefore, in all cases be required for certain nanoscale materials.

The estimated cost of the Base Set is over $500,000. On page 15 of the Framework it states that it is “…strongly recommended that these base sets of information be addressed by the time of product launch. …” Decisions to develop new products and their associated costs are complex since there are no guarantees of product acceptance, and the decisions are likely to include the assessment of probable costs as well as estimated revenue generated by a new product. The addition of an additional $500,000 to product development may be a significant amount for a new nanoscale material, especially since initial market volumes may be modest for many applications. This investment is likely to influence significantly a final decision on whether to proceed with product development.

The assessment of Health Hazard as outlined in Box 3 on page 35 includes the completion of an in vivo short term toxicity test. Within this section, however, and throughout the document, there is no mention of alternatives to animal testing. The Panel urges that ED and DuPont consider alternatives to animal testing. The Panel specifically urges ED and DuPont to consider using a tiered approach to establishing a base-set of data and that the tiered approach involve alternatives to animal testing where appropriate alternatives methods are available.

The Panel also urges ED and DuPont to consider that where possible, the conduct of the proposed base set experiments be aligned to the greatest extent possible with chemical testing guidelines available from the Organization for Economic Co-operation and Development (OECD). Furthermore, in cases where there is a need to deviate from OECD guidelines, the reasoning for the change should be explicit and well documented. For example, the Panel would expect a more comprehensive rationale be provided for a 90 day observation period in the 28 day in vivo study. Additionally, the Panel questions the value of a single-dose instillation study when compared with the proposed alternatives to a repeat oral or inhalation exposure study.

Life Cycle Considerations Should be Clarified

The Panel strongly supports appreciation of the implications on nanoscale materials through the entire lifecycle of a nanoscale material. The Panel believes, however, that there may be fundamental confusion regarding the use of the term “lifecyle” in step 2 of the process which is currently termed “Profile Lifecycle(s)”. The term “lifecycle” is used in this context to highlight the need comprehensively to assess a nanomaterial’s properties, hazards, and exposure throughout its lifecycle. The use of this term, however, does not align with what is commonly referred to as a “life cycle analysis.” The Panel urges ED and DuPont to consider replacing the term “lifecycle(s)” in step 2 with a different phrase, such as “Evaluation of EH&S properties throughout the lifecycle.” This change would avoid confusion and perhaps more faithfully express the concept ED and DuPont intended to convey is using the term “lifecycle.”

Other Comments

• Paragraph 1, page 2- References are made to reports from Lux Research and the Woodrow Wilson International Center for Scholars. The Panel has reviewed these reports and believes the market value of nanomaterials in use and the numbers of products in which nanoscale materials are actually used may be exaggerated and inaccurate. While these reports provide useful information, the failure to define clearly the actual number of products enabled by nanotechnology may inaccurately convey an unfounded perception of risk to the public from nanoscale materials. The Panel urges ED and DuPont to correct this misperception.
• Page 10 – Applications. The Panel is unclear what is meant by a “high-volume use” and urges ED and DuPont to define and/or clarify this term.

The Panel appreciates this opportunity to comment on the draft ED and DuPont draft document, “A Framework for Responsible Nanotechnology”. The Panel remains firmly committed to the responsible development of nanotechnology, and will continue to explore and develop ways to promote the safe and responsible development of nanotechnology.

Sincerely,

William P. Gulledge
Manager, Nanotechnology Panel
American Chemistry Council