By Georgia D. Koutouzos, J.D.
Burgeoning technology has potential problems with both the processes themselves as well as the products ultimately produced.
Acknowledging the rapid development of 3D printing and additive manufacturing (3D/AM) processes, a U.S. Consumer Product Safety Commission Staff report outlined a myriad of potential hazards associated with those processes and end products that may be addressed through standards development and educating 3D/AM users on good manufacturing, environmental, health, and safety practices (Safety Concerns Associated with 3D Printing and 3D Printed Consumer Products, May 6, 2020).
What is 3D/AM? The rapid development of 3D printing and additive manufacturing (3D/AM)—a process of building products and parts for products by adding material generally in a vertical layering process—is expected to change product design, manufacturing, and distribution significantly. What began as a technology that provided a quick method to produce prototypes, 3D/AM is rapidly growing in industrial and consumer product uses, due, in part, to widespread adoption of computer-aided design software, availability of open-source software, and a wider selection of materials.
Manufacturers currently are using additive manufacturing to produce parts for consumer products, because it may simplify the manufacturing process and allow new, innovative designs that previously were impossible to produce using traditional manufacturing methods. Limitations such as materials, speed, and equipment cost limit the size and practical applications of printed parts at the present time, but those hurdles are expected to be overcome as the technology advances.
Types of processes. There are several types of 3D/AM processes, with the method selected typically a function of the equipment available to the hobbyist or firm, the materials used, and the cost, speed, and design requirements of the printed product. Printer cost usually is a function of part quality and production speed. The main processes used today include: (1) fused filament fabrication (a. k. a. fused deposition model) ; (2) stereo lithography; (3) digital light processing; (4) liquid crystal display; (5) selective laser sintering ; (6) direct metal laser sintering; (7) selective laser melting; and (8) electron beam melting.
Advantages. 3D/AM offers many advantages to product designers and manufacturers over traditional manufacturing techniques. It opens up opportunities for significant improvements in the ability to customize products to customer preferences, as product manufacturing can be adapted without major retooling. 3D/AM can reduce costs and lead times because highly complex parts can be produced on demand. Product designers no longer are limited by considerations of traditional machining or materials. Suppliers can produce component parts, as needed, and in a non-traditional manufacturing setting, or via "distributed manufacturing" sites ("distributed manufacturers" describes the use of more advanced printers in non-traditional "manufacturing" sites, such as consumers’ homes, for commercial production).
Potential hazards. According to the CPSC Staff, there are two broad hazard areas for 3D/AM: (1) hazards posed by use of a 3D/AM process; and (2) hazards posed by the printed products. Each of those hazard areas includes potential fire and combustion hazards, electrical hazards, chemical hazards, and mechanical hazards. In addition, 3D/AM consumer products—particularly children’s products—may not meet applicable regulations or voluntary standards, due to the 3D/AM manufacturer’s potential unfamiliarity with federal regulations and voluntary standards applicable to those products, especially for small and micro-producers that are new entrants to the market.
Among the potential hazards associated with 3D/AM across the product lifecycle are the safe storage and use of raw materials, the fabrication of a consumer product from the material during the printing process, and the end use of the product by the consumer. These hazards are of particular concern for 3D printing in consumers’ homes, where the environment and expertise are more likely to be inadequate in comparison to AM used in industrial settings, the Staff said, adding that thermal, fire and combustion, electrical, and mechanical hazards associated with 3D/AM printers can be mitigated with adherence to the appropriate voluntary standard, which may be demonstrated by printer manufacturers through product certification.
Complicating the analysis is the fact that there are no data on injuries from 3D/AM printed products, the Staff said, noting its belief that the lack of data is due to limitations in the reporting requirements. For example, reports may not identify products as manufactured via 3D/AM, and chemical hazards, especially chronic hazards, are often difficult, if not impossible, to identify in incident reports.
Potential health effects. The CPSC Staff also expressed its concern about the potential health effects of materials used for 3D/AM and the potential for consumer exposures. To that end, the Staff said that it is working along multiple fronts, including voluntary standards development and research. The Staff has developed interagency agreements with CPSC’s federal partners to investigate the potential health effects of materials used in, and chemical and particulate (including nanoparticle) emissions from, 3D/AM and potential consumer exposure.
Data security issues. Finally, because 3D/AM printers may be connected to the Internet for remote access, downloading open-source software and monitoring software performance, the Staff said that it is important for these printers to have adequate data security protection to safeguard the software and safety of the printer. "Data Security," as used in an Internet of Things (IoT) product, concerns all the data stored in, or moving in or out of, a connected product, which could impact the safety of the product. These include:
- Operational instructions (software) ;
- Consumer-originated data (biometrics, settings and preferences, multiple-user identification) ;
- Environmental metrics (e.g., location, temperature, atmosphere, energy) ; and
- Manufacturing/product data (e.g., serial numbers across products).
The advent of 3D/AM processes has accelerated new product designs, and the demand for production in small-scale, educational or consumer settings has also expanded. 3D/AM products have few limitations in design and distribution. Free, open-source software allows novice product designers and home-based manufacturers to design and produce consumer products.
Standards need to be developed. Direct 3D/AM can be inexpensive enough to reduce barriers to entry into manufacturing sectors without the expertise common in the traditional manufacturing process, which may lead to increased safety hazards and diminished compliance with applicable safety regulations and voluntary standards. CPSC Staff has identified a myriad of potential hazards associated with 3D/AM processes and end products, which may be addressed through standards development and educating 3D/AM users on good manufacturing, environmental, health, and safety practices.
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