The following is a list of answers to Frequently Asked Questions about our project that we hope will be helpful for individuals or organizations interested in learning more about the project.
FREQUENTLY ASKED QUESTIONS
1. Materials Information
a. What is the nature of the material(s) being sought/selected for the project?
Ideally the material will be used commercially in consumer products. If not in consumer products, the material could be used in industrial products. The goal is to use materials that are in the market, are representative of what is in the market, or will be in the market soon, and to develop an understanding of how the test material qualities compare with the range of similar materials in commerce and key variables that may affect the ability of the method(s) to detect releases. In addition, a control material will be used, as described below.
b. How should the material be selected?
The selection should be based on a good understanding of the characteristics of commercial materials to ensure that the analytical methods we develop adequately take into account critical characteristics that may affect method sensitivity and specificity. Therefore, openness from suppliers about the range of materials in commerce and their various differential features will help build confidence in the appropriateness of the methods developed for testing commercial goods. In the case of multiple materials being available for selection, it would help to have additional information for each material (such as characterization and complexity relevant to downstream assessment approaches for release). The most important point is for materials to be representative of the commercial market. Further, the study design should demonstrate that our methods are capable of detecting release if there is such. Demonstration of release detection capability of our methods is a distinct prerequisite from actual determination of release of real world products.
We recognize that full openness may not be possible due to confidential business information. It is important that we are transparent in our process for selection of materials, however we recognize that there may be manufacturer CBI issues that need to be addressed in order to get an appropriate level of detailed information to guide our product selection. Where CBI is concerned, we plan to work in partnership with the manufacturers through a dialogue so as to obtain useful information on material characteristics for optimum methods development. The blinding of aspects of testing will require further negotiation when more details have been decided regarding study design. Ultimately there will need to be a high level (generic) description of the selection approach and material.
c. Should the MWCNT/polymer composites be on the market?
Ideally, yes, but it is more important that the materials are sufficiently representative of a range of materials that are in commerce, to ensure that the project outputs are relevant to materials in actual use. In addition, see the next question for information on the selection of a positive control. The aim of the project is to develop test methods that can detect any releases that may occur from real-world materials. Therefore, it is important to develop the analytical methods based on the best understanding possible of the products on the market.
d. Should the MWCNT/polymer composites be created especially for the NanoRelease project?
Although uniquely created material is not preferable for overall methods testing, it may be necessary in order to create a reliable positive control sample that can be used for methods validation. In creation of new materials for positive controls, the intention is to develop and validate methods, not to develop data about release. There would be a clear distinction between this created sample and “real-world” or “on-the-market” samples. Should it be necessary, we would expect the created sample to be made with relevant components (i.e. those that are used in “real world” samples).
e. If necessary, will it be possible to use one type of polymer for different types of MWCNTs?
Yes, it is possible. While the ultimate design has yet to be finalized, we envision running tests with a number of different polymer matrices, and possibly different types of MWCNTs to understand if/how the matrix and MWCNT characteristics affect test method validity. Depending on the ultimate scope of the project, it is possible we may have a number of types of MWCNTs in one type of polymer and/or vice versa.
2. Agreements with Manufacturers to Obtain Materials for Testing
a. Does the SC want a final materials supply agreement before a finalized & manufacturer-accepted testing protocol?
At this point in the project, we cannot yet choose materials as we do not have our methods and scenarios finalized. Hence, the protocol will evolve in an iterative fashion; reflecting both the materials and scenarios of interest, as determined by our consensus-based stakeholder process and not by a protocol or material supply agreement. We welcome supplier input to the design of the analytical method, but protocol development is a separate, independent process from the process of securing materials.
3. “Extreme” Samples
a. Will “extreme”/positive control samples be tested? (i.e., high release, low release).
The aim is to develop methods that are reliable in detecting releases from a broad range of scenarios that may occur through the life cycle of materials containing MWCNTs. We do expect that for validation purposes, we will need to develop positive controls that most likely will reflect very high and very low release scenarios. This is further discussed in question (1d) above and in (3b) below.
b. If so, will these samples be created? (i.e., sample designed for high release)
Yes, we expect to have to create some positive control samples and would greatly appreciate any information that might be helpful in their design. These samples would be purposely designed to produce a known release of MWCNT-related elements that are detectable and measureable in a range relevant to realistic exposure assessment, not representative of conditions of the products on the market. This distinction is an important one and will be appropriately and clearly communicated throughout the project, including communication of results. Positive controls play a critical function in providing validation for any scientific test methodology.
4. End User Articles
a. What about the articles/products employing the MWCNT/polymer composites (by manufacturers’ end users)? Will NanoRelease test these in the future?
This has not been decided but it is clear that when methods are identified by the NanoRelease Project they will be published and it is hoped they will be useful to evaluate commercial products in a consistent and transparent manner.
b. If so, what is the purpose of testing MWCNT/polymer composites?
The test systems (MWCNTs in polymers) will be designed to gain an understanding of how or whether certain material characteristics affect the accuracy of measurement methods for any releases that may occur. We foresee the method development as an iterative process that first demonstrates proof-of-concept with composite materials, and then is tested subsequently with finished articles/products made with those materials, and later, in various scenarios relevant to the life cycle of specific products. Furthermore, the project may have the potential to build a story of release potential from raw materials to finished products that more fully consider additional coatings and other factors that may prevent release of materials from end-use products. Such understanding is not simply practical knowledge of relevant release potential, but it provides the critical underpinnings for the design of safe products.
c. Will end users feel that they have been involved in something irrelevant or unfavorable?
The project is designed to meet the shared goal of all participants in advancing the development of effective tools to ensure that nanomaterials are safe – an outcome that we hope all would agree is both relevant and favorable. We seek broad participation from a wide variety of stakeholders in order to learn from each other. A key to success is robust information upfront that builds the clearest possible understanding of commercially relevant materials and characteristics. Hence, end user participation to share their knowledge will only increase the likelihood of a favorable outcome.
5. Use of Final Data
a. What do the regulatory agencies intend to do with the data developed by the project?
The NanoRelease project is not designed primarily for regulatory purposes, but aims to develop scientific tools necessary to generate critical information for decision-making among NGO, business, and government stakeholders alike. We are pleased to have a broad set of regulators from Canada and the U.S. collaborating with us, who, like their business and public interest counterparts, share the common goal of ensuring safety and sustainability of nanomaterials. Data generated from this project alone is not sufficient to characterize exposures and thus, would not be sufficient to assess risk or determine regulatory outcomes. With that said, insights from this project could prove valuable for developing quality exposure and risk assessments. Current knowledge on release potential is severely limited by the lack of reliable test methods, resulting in risk assessments founded on unscientific assumptions about product safety. This project will enable significant refinements in both methodology and practical thinking on how release potential should be considered. While no participant in the project can ignore any legal obligations that may arise as a part of the project, the primary goal of this project is to develop effective measurement tools, not to use those tools to make a judgment about a particular manufacturer or material, nor to create regulations. This research should not and will not inappropriately stigmatize the materials or technology. By ‘stigmatize’, we refer to false accusation of untrue information. The research should provide approaches that will allow for appropriate, consistent, and transparent measurement of nanomaterial release.