Sustainability and Life-Cycle Issues - ACS Symposium Series (ACS

Chapter 9

Sustainability and Life-Cycle Issues

Downloaded by CORNELL UNIV on September 13, 2016 | http://pubs.acs.org Publication Date (Web): August 29, 2016 | doi: 10.1021/bk-2016-1220.ch009

Jeffrey Morris* Office of Pollution Prevention and Toxics, Environmental Protection Agency, Washington, DC 20460, United States *E-mail: [email protected].

U.S. EPA’s Office of Pollution Prevention and Toxics has over 10 years of experience engaging with the regulated community, scientists, the international community, and others on the regulation of manufactured nanomaterials. As of November 2014, EPA had made regulatory decisions on over 160 nanomaterials for which EPA had received premanufacture notification. This article will discuss the lessons EPA has learned in evaluating nanomaterials with respect to environmental sustainability across the life cycle, and what challenges remain in developing and applying scientific information to determine the safety of manufactured nanomaterials.

Regulatory Decision Making Numerous decisions go into developing nanomaterials. Clearly, most of those decisions center on material performance and the business case for incorporating a nanomaterial into a product. In addition to those considerations, to advance the development of environmentally sustainable nanomaterials, a life cycle perspective is needed. For regulators, the decisions that go into the design of products and molecules have implications for chemical safety. When the regulatory science community looks at metrics of environmental sustainability for nanomaterials, it is useful to understand the decisions made by designers, fabricators, and manufacturers when they consider what properties to incorporate into their materials. Not subject to U.S. Copyright. Published 2016 by American Chemical Society Cheng et al.; Nanotechnology: Delivering on the Promise Volume 1 ACS Symposium Series; American Chemical Society: Washington, DC, 2016.


In general, applying life-cycle assessment to nanomaterials will require considerably more information than we currently have because, to date, the scientific community has incomplete information on what attributes of nanomaterials drive their behavior in air, water, land and biological systems. When the regulatory science community looks at a particular material type, it typically faces uncertainty about how the nanomaterial’s design features will affect its movement and behavior in the environment. If nanomaterial designers do not, or are not able to, apply life-cycle thinking to how their nanomaterials will be produced, used, and ultimately disposed of or recycled, then opportunities will be missed to incorporate green chemistry and environmental sustainability principles into the development and application of nanotechnology. Likewise with applying life cycle thinking in regulatory decision making, regulators are concerned not only about toxicity or exposure potential at the point of use or introduction into the environment. They also consider how the nanomaterial is going to be produced and handled by humans when it is used, disposed of, and recycled, as well as how it will change as it moves through air, water, or soil. All of these parts of the life cycle are important when considering whether or not something is environmentally sustainable. Life-cycle assessment approaches have to be useful and usable for both the regulated community and regulators. People who design and make nanomaterials need life-cycle tools that are not costly to develop and use, only require data inputs that a user could reasonably expect to have available, and are “fit for purpose” in the sense that they meet the needs of the user and the particular nanomaterial being evaluated. If nanomaterial designers and producers do not have the tools to apply life cycling thinking into their nanomaterial development decisions, then regulators will have greater difficulty in applying life-cycle thinking to regulatory evaluation. To support building life-cycle assessment models, we need to consider what information is needed to make sustainability related decisions about nanomaterials and introducing them into and the environment. This would necessitate building a database with information on many types of nanomaterials. The EPA has reviewed over 160 nanomaterials as new chemicals under the Toxic Substance Control Act (TSCA); these are materials not derived from chemicals already in the TSCA chemical inventory. The agency currently does not require nanomaterials derived from substances on the TSCA inventory to be submitted to the agency for review. Because of this, EPA likely is missing information on nanomaterials in commerce. Among other uses, such information would help EPA build out chemical categories and structural analogs for nanomaterials, which would facilitate review of reviewing new nanomaterials from life-cycle and sustainability perspectives.

86 Cheng et al.; Nanotechnology: Delivering on the Promise Volume 1 ACS Symposium Series; American Chemical Society: Washington, DC, 2016.


Reporting Rule The agency has issued a draft nanomaterial reporting rule under TSCA section 8(a). The proposal is for one-time reporting of nanomaterial substances derived from chemicals already on the TSCA inventory. If a substance used to derive a nanomaterial is already on the chemical inventory, and it has been produced within the last three years, and has not been submitted to the agency before, the proposed reporting rule would require that existing information on that material be submitted to EPA for one-time reporting. Submitted information would include physical-chemical properties, material characterization, and environmental health and safety information. The information would be reviewed to see if further analysis needs to be done. If the agency has questions about the nanomaterial, there may be the need for further discussion with the submitter. This is not meant to create a public registry of nanomaterial substances. In addition, submitters have the right to claim their information as confidential. This information is needed because there are gaps in knowledge about nanomaterials and what is being commercialized, since the EPA is seeing at this time only those nanoscale materials derived from substances that are not on the TSCA inventory. The EPA has regulated new nanomaterial substances for about a decade, and we have no indication that there has been stigmatization of those materials. The agency believes that its pre-market review of new nanomaterials enhances public confidence in nanomaterials by using the best available science to evaluate nanomaterials’ hazard and exposure potential throughout their life cycles prior ot approving them for commercialization. The agency has proposed to demarcate reporting by focusing on substances in the range of 1-100 nanometers in at least one dimension. The proposed rule describes different environmental behavior-driving properties to determine whether a nanomaterial should be reportable, such as zeta potential, surface reactivity, and solubility. Generally, if there are two size ranges (in nanometers) derived from the same substance, and they are very different in those properties, experience suggests that they may behave differently in the environment and therefore may warrant separate reporting. For new materials derived from chemicals on the TSCA inventory, the agency has asked that reporting be made within 135 days before a manufacturer’s intent to commercialize. 135 days was chosen because the agency is required to review materials within 90 days, and experience has shown that 80% of the reviewed substances go into commercialization more than 45 days after that 90-day review. The proposed rule was out for a 3-month comment period. The agency held a public meeting with web access to facilitate comment on various aspects of the rule. The EPA hopes to issue a final rule that is useful in enhancing public confidence, ensuring nanomaterials’ safety, and provides information on nanomaterials to support their safe and environmentally sustainabile commercialization. More information is available in the references (1, 2).


References 1.


2.

Morris, J.; Willis, J.; De Martinis, D.; Hansen, B.; Laursen, H.; Sintes, J. R.; Kearns, P.; Gonzalez, M. Science policy considerations for responsible nanotechnology decisions. Nat. Nanotechnol. 2011, 6, 73–77. Nel, A.; Grainger, D.; Alvarez, P.; Badesha, S.; Castranova, V.; Ferrari, M.; Godwin, H.; Grodzinski, P.; Morris, J.; Savage, N.; Scott, N.; Wiesner, M. Nanotechnology Environmental, Health, and Safety Issues. In Nanotechnology Research Directions for Societal Needs in 2020; Roco, M. C., Mirkin, C. A., Hersam, M. C., Eds.; Springer: New York, 2011; pp 159-220, DOI: 10.1007/978-94-007-1168-6_5.


Sustainability and Life-Cycle Issues - ACS Symposium Series (ACS

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