Pollution from nanomaterials

Difficulties in measurement

There is no clear consensus on potential human and ecological impacts stemming from exposure to ENMs. As a result, developing reliable methods for testing ENM toxicity assessment has been a high priority for commercial usage. However, ENMs are found in a variety of conditions making a universal testing method non-viable. Currently, both in-vitro and in-vivo assessments are used, where the effects of NPs on events such as apoptosis, or conditions like cell viability, are observed.

In measuring ENMs, addressing and accounting for uncertainties such as impurities and biological variability is crucial. In the case of ENMs, some concerns include changes that occur during testing such as agglomeration and interaction with substances in the testing media, as well as how ENMS disperse in the environment. For example, one investigation into how the presence of fullerenes impacted largemouth bass in 2004 concluded that fullerenes were responsible for neurological damage done to the fish, whereas subsequent studies revealed this was actually a result of byproducts resulting from the dispersal of fullerenes into tetrahydrofuran (THF) and minimal toxicity was observed when water was used in its place. Fortunately, greater thoroughness in the process of testing could help to resolve these issues. One method that has proven useful in avoiding artifacts is the thorough characterization of ENMS in the laboratory conducting the testing rather than just relying on the information provided by manufacturers.

In addition to problems that can arise due to testing, there is contention on how to ensure testing is done for environmentally relevant conditions, partly due to the difficulty of detecting and quantifying ENMs in complex environmental matrices. Currently, straightforward analytical methods are not available for the detection of NPs in the environment, although computer modeling is thought to be a potential pathway moving forward. A push to focus on the development of internationally agreed upon unbiased toxicological models holds promise to provide greater consensus within the field as well as enable more accurate determinations of ENMs in the environment.

Regulation and organizations

The regulation of nanomaterials is present in the U.S. and many other countries globally. Policy is directed mainly at manufacturing exposure of NPs in the environment.

International / intergovernmental organizations

As of 2013, the OECD Working Party on Nanomaterials (WPN) worked on a multitude of projects with the purpose of mitigating potential threats and hazards associated with nanoparticles. The WPN conducted research on methods for testing, improvements on field assessments, exposure relief, and efforts to educate individuals and organizations on environmental sustainability with respect to NPs.

The International Organization for Standardization TC 229 focuses on standardizing manufacturing, nomenclature/terminology, instrumentation, testing and assessment methodology, and safety, health, and environmental practices.

North America

In the United States, the FDA and OSHA focus on regulations that prevent toxic harm to people from NPs, whereas the EPA takes on environmental policies to inhibit harmful effects nanomaterials may pose on the planet.

As of 2019, there were supporters and opponents of increased regulation. Supporters of regulation want NPs to be seen as a class and/or have the precautionary principle applied. Opponents believe that over-regulation could lead to harmful effects on the economy and customer and economic freedom. As of 2019, there were multiple policies up for consideration for the purpose of changing nanomaterial regulation.

The EPA is tackling regulations through two approaches under the TSCA: information gathering rule on new to old NMs and required premanufacturing notification for novice NMs. The gathering rule requires companies that produce or import NMs to provide the EPA with chemical properties, production/use amounts, manufacturing methods, and any found health, safety, and environmental impact for any nanomaterials being used. The premanufacturing notifications gives the EPA better governance over nanomaterial exposure, health testing, manufacturing/process and worker safety, and release amount which can allow the agency to take control of a NM if it poses concerning risk.

The United States National Nanotechnology Initiative involves 20 departments and independent agencies that focus on nanotechnology innovation and regulation in the United States. Projects and activities of NNI span from R&D to policy on environment and safety regulations of NMs.

NIEHS built itself from the complications that came with conducting research and assessment on nanomaterials. NIEHS realized the rapid adoption of NMs in products from a large variety of industries, and since then the organization has supported research focused on understanding the underlying threats NMs may pose on the environment and people.

The Canada-U.S. Regulatory Cooperation Council (RCC) Nanotechnology Initiative was constructed in order for the U.S. and Canada to protect and improve safety and environmental impacts of NMs without hindering growth and investment in NMs for both countries. The RCC oversees both countries and has maintained regulations, worked to create new regulations with the goal of alignment, secure transparency, and ensure that new and beneficial opportunities in the nanotechnology sector were shared with both countries.

Europe

Nanomaterials are defined consistently in both Registration, Evaluation, Authorisation and Restriction of Chemicals and Classification, Labeling, and Packaging legislations, in order to promote harmony in industry use. In January, 2020 REACH listed explicit requirements for businesses that import or manufacture NMs in Annex I, III, VI, VII-XI, and XII. Reporting of chemical characteristics/properties, safety assessments, and downstream user obligations of NMs are all required for reporting to the ECHA.

The Biocidal Products Regulation (BPR) has different regulation and reporting requirements than what is stated in REACH and CLP. Data and risk assessments are required for substance approval, specific labeling requirements are needed, and reporting on the substance which includes current use and potential risks must be done every 5 years.

Asia

The Asia Nano Forum (ANF) focuses on ensuring responsible manufacturing of nanomaterials that are environmentally, economically, and population safe. ANF supports joint projects with a focus on supporting safe development in emerging economies and technical research. Overall, the organization helps promote homogenous regulation and policy on NMs in Asia.

The Chinese National Nanotechnology Standardization Technical Committee (NSTC) reviews standards and regulation policies. The technical committee SAC/TC279 focuses on normalizing terminology, methodology, assessment methods, and material use in the field. The committee develops specific test protocols and technical standards for companies manufacturing NMs. In addition, the NSTC is constantly adding to their nano-material toxicology database in order to better standards and regulation.