Chemicals

Sometimes, It’s the Little Things That Get You: New Guidance on Engineered Nanomaterials

When Martians invaded Earth in H.G. Wells’s novel, War of the Worlds, none of Earth’s armies and none of Earth’s weapons could stop their relentless march. What ultimately saved humanity? A microscopic bacterium. As the unfortunate Martian invaders discovered, sometimes it’s the little things that get you. In a nonfiction analogue, researchers who work with engineered nanoparticles are finding that their march of progress could be derailed, if they’re not careful, by their very tiny creations.

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Regulatory agencies and nongovernment organizations (NGOs) are playing catch-up with their guidance: The World Health Organization (WHO), the Food and Drug Administration (FDA), and the European Chemicals Agency (ECHA) have all issued new guidance on the management of nanoparticles within the past 2 months.

World Health Organization: Worker Protection Guidelines

The World Health Organization published its WHO Guidelines on Protecting Workers from the Potential Risks of Manufactured Nanomaterials on December 12, 2017. The WHO guidelines are different from guidelines issued by some other international organizations in that they are tailored for use by small- and medium-sized enterprises, and by businesses in low- and middle-income countries. So, for employers whose supply chain includes manufactured nanomaterials that are created or used by employers in those categories, the WHO guidelines may offer useful advice.

The general worker protection best practices recommended by the WHO guidelines are for employers to:

  • Address the hazards of manufactured nanomaterials by groups. Some nanoparticles share specific toxicity; others have similar fibrous configuration or are granular biopersistent particles.
  • Provide worker education and training in the specific health and safety issues of manufactured nanomaterials.
  • Include workers in all phases of risk assessment and control.

Food and Drug Administration: Draft Guidance on Drug Products

The FDA announced in the December 18, 2017, issue of the Federal Register that its draft guidance document, Drug Products, Including Biological Products, that Contain Nanomaterials; Guidance for Industry, is now available for public comment until March 19, 2018. The guidance is intended to address human drug products in which a nanomaterial is present in the finished form. The guidance is necessary, in part, because formulations that include nanoparticulate forms of compounds are not necessarily biologically equivalent to other drug products. The document notes that it primarily addresses nanoparticulates in the context of drug safety and consistency, and good manufacturing practices—for example, nanoparticulate materials are readily dispersible, so it is vital to prevent cross-contamination in the manufacturing process.

The FDA notes that its new guidance “does not comprehensively address considerations that may be advisable to address compliance with legal obligations under other authorities, including those related to protection of occupational safety and health.” However, many of the practices that make for safety in the ultimate product, like preventing the uncontrolled dispersal of nanoparticular materials, are also critical to worker safety.

European Chemicals Agency: REACH Guidance for Nanomaterials

Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) is a regulation of the European Union (EU), first implemented in 2007, whose purpose is to improve the protection of human health and the environment from the risks that can be posed by chemicals. REACH also encourages minimization of animal testing through the use of alternate hazard assessment methods.

Under REACH, companies are required to identify and manage the risks linked to the chemical substances they manufacture and market in the EU. They have to document how the substance can be safely used and communicate those risk management measures to the users. The ECHA is empowered to restrict the use of substances whose risks cannot be adequately managed.

ECHA held a webinar on November 30, 2017, to explain how companies should complete support documentation for nanomaterials in their REACH registration dossier. Included in the webinar were updates for information requirements for human health and the environment.

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