Nanotechnology risks: A 10-step risk management model in nanotechnology projects

The use and handling of particulate material between 1 and 100 nm, also known as nanotechnology, has been shown to have potential to revolutionize many aspects of industries, medical practices and the human environment. However, very little is known about the risks and hazards of nanomaterials to humans and the environment, so a conservative approach is encouraged. This article proposes a 10- step qualitative risk management model for nanotechnology project managers, which enables them to detect significant risks in a systematic approach and provide decisions and suitable actions regarding the health of their employees.

The properties of materials at atomic and molecular size range (between 1 and 100 nm) are significantly different from those at a larger scale. This emerging technology is based on the size and surface condition of solid particles (1,2). The recent development of nanotechnology introduces different types of risks such as economical and health risks, and according to recent literature the risks involved in engineered nanoparticles are still not addressed (2). Project managers have been forced to make decisions regarding new products based on nanotechnology with insufficient information about the risks and as a result over-encouraged the use of nanotechnology (3,4).
Recent studies have shown that some nanomaterials or nanoparticles may have the potential to cause damage to exposed humans or ecosystems (5,6,7). For instance, carbon nanotubes have been described to induce asbestos-like inflammation in mice (8). In general, studies show that awareness of nanotechnology is low and knowledge of this revolutionary technology is limited (9,10). However, nanotechnology has the potential to revolutionize a wide range of economic and health-related activities such as electronics, packaging, labeling, paint and coatings, low energy-consuming batteries, targeted therapies and diagnostic smart tools, etc. (11).
Risk assessment is the determination of risks related to human or environmental exposure to a hazardous substance and the amount of risks involved depends on specific properties of the substance (12). The environment and humans are exposed to nanoparticles on a normal basis, particularly from combustion processes, vehicle engines or even volcanic explosions. It seems that nanoparticles can penetrate into the body through respiration, dermal exposure and ophthalmic contact but also by consumption of food and drink. However, the health impacts will most likely depend on their surface area, surface composition and reactivity, along with the other specificities that define them as nanomaterials. After entering the body, it is possible that nanoparticles can cause toxicity even with sparse amounts at the neural and cellular level within the brain (13).

Health Risk Management of Nanotechnology
The lack of knowledge about the risks involving nanomaterials to humans and the environment is a major issue. There are several reasons to think that nanomaterials could have harmful health impacts, especially for people working closely with nanomaterials. But the extent of the hazards and risks involved are essentially unknown (14). As for conventional chemicals, the objectives of project risk management are to eliminate risks to humans and the environment or at least to reduce them to acceptable levels (15). Due to a lack of published systematic evidence and possibly a lack of suitable testing protocols, uncertainty is a general problem of nanotechnology (16).
The objective of risk management is the identification and management of significant risks. It consists of several key steps, with feedback through a control and monitoring process. Risk management overlaps with other management processes in most projects, which is usually undertaken as part of normal project management (17).

Figure 1: A 10-step risk management model in nanotechnology projects

We suggest a 10-step model for nanotechnology risk management in related projects and believe that these considerations could considerably control the hazardous effects of the materials in workplaces and the environment.
Step 1:
A basic knowledge of the work is essential for doing an adequate assessment. Therefore, workplace personnel who have extensive knowledge of the field should always be involved.
Consultation between managers and employees benefits the assessment and will help in providing information about the substances used, how the work is performed, exposure to nanomaterials and commitment to quality control.
Project managers might do the assessments themselves when working in a small workplace, or it might be necessary to establish a team in a larger workplace. The assessment team should have abilities to understand the information in the protocols and labels, inspect the conditions of work and forecast potential problems. They also should communicate efficiently with employees and possible stakeholders for making valid conclusions about exposures and risks and finally report the findings accurately.
Step 2:
To be able to make a thorough risk assessment, divide the work into sections, subsections and tasks or process-units according to Work Breakdown Structure (WBS).
Step 3:
Identify all nanoparticles that are, or will be, used or produced in every work unit and process. A nanoparticle might be produced in the form of a powder, liquid, gel, vapor, dust, mist or fume in the workplace.
Step 4:
Identify the type of nanoparticle. Nanoparticles can be found in several forms, from relatively safe such as engineered insoluble nanoparticles in a matrix to more hazardous forms such as free nanoparticles.
Step 5:
The supplier should provide information about the nanomaterials. However, for most nanomaterials, Material Safety Data Sheets (MSDS) are not available, so it will be necessary to obtain adequate information from other sources such as textbooks, provided standards, technical reference sources, scientific papers, reports, trade journals, electronic online databases or experience from a previous use of similar substances or processes.
Step 6:
How are hazardous nanoparticles released into the work area? Are persons exposed to hazardous nanoparticles through respiration, skin, ingestion or eye contact, or is there a possibility of accidental injection into the body? A ‘walk through’ inspection will provide information about each of the work units. It is important to talk to the employees at each location and ensure that all persons that could be exposed to nanomaterials are covered. If a new assignment, process or work unit is being planned but not yet in operation, evaluation of the relevant work process, plan or design is needed.
● Is there nanoparticle exposure?
● How much and how long are the personnel exposed?
● Is there an intermittent or continuous exposure?
● Is there a frequent exposure?
● What kind of control measures could be used or proposed?
● Are the existing controls sufficient?
● Are there any risks related to the storage and transport of nanomaterials?
Step 7:
A significant risk involves serious health effects to people in the workplace (18), for instance by inhalation of nanoparticles or working with highly toxic nanoparticles (e.g. nanobased anticancer drugs). Consider the nature and severity of the hazard and the degree of exposure of people involved in the process. For summarizing the evaluation process, four decisions could be made:
Decision 1:
There are not significant risks at the moment and they are not likely to increase in the future.
Executions: Go to step 9 and end current assessment but review the assessment if the situation changes.
Decision 2:
There are significant risks but they have already been effectively controlled. There might be a possible increase in the future.
Executions: Maintain control procedures and minimize chances of higher exposure occurring. Establish additional control procedures (see Step 8) if a high-risk event occurs despite previous precautions. Review assessment steps if the situation changes.
Decision 3:
There are significant risks present and they are not adequately controlled.
Executions: Determine and implement actions for preventing or controlling exposure immediately.
Investigate and implement a possible stop in the production.
Begin reviewing if more controls are required.
Evaluate the exposures again if the upgraded control procedures are used.
Establish employee-training programs.
Decision 4:
There are uncertainties about the risks involved – not enough information or uncertainty about the degree of exposure.
Executions: Find more information or conduct a more detailed assessment.
Request specialist advice if necessary and decide using suitable actions presented in conclusion 1, 2 or 3.
Apply a good practice to minimize exposure meanwhile.
Step 8:
If the assessment shows that there are significant risks to health, besides the executions mentioned in step 7, further actions should be acquired if needed:
● Complementary employee training
● More precise monitoring procedures
● Health surveillance system
● First aid and emergency facilities
Step 9:
The record should be concise and should include a description of the work unit, name of assessor or assessment team personnel, date, time and a list of hazardous nanomaterials used or produced in the project unit. It should also include a summary of the process containing a description of normal operations in the project unit, with a note of any changes observed or anticipated which might affect accuracy of assessment; risk identification, including possible routes of exposure; procedure for assessment of exposure; the degree of exposure and existing control procedures. The above mentioned record should be saved either on paper or electronically in a permanent format.
Step 10:
Review and regulation of the assessment is required if:
● There should be significant changes in project products, work, material, process or control procedures
● Nanoparticle-related intoxication is reported
● Inadequate control procedures are reported
● New evidence about risks of nanoparticles emerges from recent publications
In these circumstances using a new or improved control method becomes reasonable.
Evaluation of the Hypothesis
Nanomaterial quantitative risk assessment approaches should be established to be able to perform more precise toxicological dose response long-term studies.

This article suggests a 10-step qualitative risk management model for nanotechnology project managers. The authors believe that the impacts of hazardous nanoparticles on human health and the environment could be prevented by limiting exposure. These steps enable project managers to detect significant risks in a systematic approach and provide decisions and suitable actions regarding the health of their employees and also help them to record and document the information.

About the authors
Saeid Goudarzi is a medical doctor, MPH and PhD candidate in Nanobiotechnology and currently works on Nanobiosensors. Abdolreza Babamahmoodi is an Assistant Professor at the Research & Technology Deputy of Tehran University of Medical Sciences and has a PhD degree in Research Management. Both have worked on the framework of this hypothesis.

Authors’ Contributions
Professor Mohammad Farhadi, Professor Seyed Kamran Kamrava and Dr Fariborz Mobarrez help us to write the initial draft. All authors read and approved the final draft of the manuscript.


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