NORA Manufacturing Sector Strategic Goals
927ZJMW - Applying PtD to the Safe Handling of Engineered NanomaterialsStart Date: 10/1/2009
End Date: 9/30/2013
Principal Investigator (PI)Name: Donna Heidel
Funded By: NIOSH
Primary Goal Addressed9.0
Secondary Goal Addressed
Attributed to Manufacturing
This project will develop a PtD strategy, similar to the one implemented by the pharmaceutical industry, and related guidance for the safe development, synthesis, product manufacturing, and ultimate disposal and/or recycling of engineered nanomaterials or nanomaterial-containing products. In addition, it will lay the groundwork for the safe design of nanomaterials including moderating toxicity by changing physicochemical parameters and focusing on some of basic science from National Institute of Environmental Health Sciences (NIEHS) "safe by design" and Environmental Protection Agency (EPA) “design for the environment” efforts.
Prevention through Design Cross-Sector Program
Nanotechnology Research Center
The major output of this workshop is the development of a strategy for including PtD into the development, synthesis, and production of engineered nanomaterials. Intermediate outcomes include: the structure for creating and adopting health hazard bands for various types of engineered nanomaterials; the exposure control technologies/equipment and expected performance for nanomaterials with adequate toxicity data to establish target exposure control ranges (health hazard bands); the techniques for reducing health hazard and minimizing exposure risks, including molecular designs of the nanomaterial itself as well as physical form of the nanomaterial (slurries/suspensions rather than dry solids); the design of support equipment, such as HVAC systems, including filtration, area pressurization and directional airflows; and the recycling, waste minimization, and disposal methods.
1. Outline a plan for the workshop that will assure achieving the identified workshop outcomes. These are:
o A PtD-oriented strategy to pro-actively assess and manage exposures to engineered nanomaterials during molecule synthesisand product development activities published as summary proceedings from the workshop;
o A plan for applying and validating control-focused guidance, based upon health hazard banding/control banding concepts, and including the environmental aspects to develop appropriate recycling, waste minimization and disposal guidance;
o Identification and enlisting of relevant operations and facilities for implementing the strategy in various pilot-scale demonstrations involving synthesis of engineered nanomaterials or the manufacturing of products with nanomaterials, to be evaluated and considered for adaptations for other operations or on a larger scale.
o Approaches for training the workforce involved in nanotechnology research, synthesis and product formulation on the safe handling of engineered nanomaterials and associated waste streams.
Include essential stakeholders, issues, and contextual factors that must be addressed. Include a needs assessment plan based on input from NIOSH, workshop sponsors and essential stakeholders. (Q1 2011)
2. Organize a planning committee including NIOSH-recommended stakeholders and sponsoring organizations. Include representatives from the following organizations: National Institute of Environmental Health Sciences (NIEHS), the Environmental Protection Agency (EPA), the Occupational Health and Safety Administration (OSHA), the Consumer Product Safety Commission (CPSC), the Nano Business Alliance, and the American Industrial Hygiene Association (AIHA). Others can be considered. (Q2 2011)
3. Working with the planning committee, develop the workshop purpose, refine the expected outcomes, and organize the breakout discussion groups. Preliminary plans for the workshop include ½ day plenary session, followed by a full day for break-out discussions and concluding with a ½ day of break-out reports, discussions and closing remarks. Two break-out groups are planned; one to focus on the minimization of hazards of the nanomaterial at the molecular level as well as the appropriate exposure controls to adopt during discovery/early development, and the second to discuss the process containment and exposure controls for synthesis of nanomaterials and the formulation of nanomaterial-containing products. (Q3 2011)
4. Develop the agenda. Coordinate the identification of plenary session speakers. Specific topics will focus on challenges and resources for developing effective controls for nanomaterials with inadequate data sets to establish appropriate occupational exposure limits and validated sampling and analytical methods. These topics include the structure for creating and adopting health hazard bands for various types of engineered nanomaterials; the exposure control technologies/equipment and expected performance for nanomaterials with adequate toxicity data to establish target exposure control ranges (health hazard bands); the techniques for reducing health hazard and minimizing exposure risks, including molecular designs of the nanomaterial itself as well as physical form of the nanomaterial (slurries/suspensions rather than dry solids); the design of support equipment, such as HVAC systems, including filtration, area pressurization and directional airflows; and the recycling, waste minimization, and disposal methods. (Q4 2011)
5. Host the workshop. (FY 2012)
6. Develop the outputs (compendium of controls, summary of workshop outcomes, educational programs. (FY 2013)
PtD has been successfully implemented as the strategy for ensuring the health and safety of scientists engaged in the discovery and development of novel new molecular entities in the pharmaceutical and biopharmaceutical industries, and that strategy should be useful to industries developing nanomaterials. Using a systems-based strategy designed to protect the scientist while facilitating the discovery of highly specific, and therefore, potentially highly toxic drug candidates, scientists adopt “default” controls, based on the therapeutic class and structure-activity relationship of the drug candidate under investigation. The prescribed controls provide appropriate level of protection while allowing for the manual manipulation of the drug candidates that is required at the discovery stage. As toxicity and physical information about the drug candidate is developed, the compound is placed into a health hazard band. This health hazard band allows the scientist to determine the appropriate control strategy, also called “control band” after factoring the physical form, quantity handled, duration of exposure, and potential of the activity to result in occupational exposures (e.g., dermal or respiratory). The effectiveness of the controls, both engineering and work practice, are verified using engineering test protocols or semi-quantitative methods using surrogates. This knowledge is provided to the process and facility design engineers so they can include the appropriate level of containment and control into the design of the manufacturing facility, mechanical systems, process equipment and waste water treatment. Supplementing this health hazard banding/control banding strategy is the adoption of “green chemistry” techniques to reduce or eliminate the hazards associated with chemical starting materials and, subsequently, to the residuals in the process intermediates, as well as to organic solvents.
As a result of this PtD strategy, the pharmaceutical industry has successfully developed and formulated hundreds of drug products containing high- or extremely-high potency active pharmaceutical ingredients with minimal health effects in their worker population. We believe that this systems-based, PtD strategy will serve as a model for the discovery, development, and production of novel nanomaterials. Although there are process and equipment differences between pharmaceutical product and engineered nanomaterials development activities, the concept of identifying and eliminating hazards, and anticipating and minimizing risks during design adopted by the pharmaceutical industry represents a valid strategy for the nanotechnology industry.
Research on the potential applications of nanotechnology continues to expand rapidly worldwide. New nanotechnology consumer products emerge at a rate of three to four per week. Over the course of the next decade, nanotechnology could have a $1 trillion impact on the global economy and em¬ploy two million workers—half of them residing in the U.S. While nanomaterials present seemingly limitless possibilities, they bring with them new challeng¬es to understanding, predicting, and managing potential safety and health risks to workers. Some of the processes used in their pro¬duction (e.g., formulating and applying nanoscale coatings) may lead to expo¬sure to nanomaterials, and the cutting or grinding of such products could re¬lease respirable-sized nanoparticles. Maintenance on production systems (including cleaning and disposal of materi¬als from dust collection systems) is likely to result in exposure to nanoparticles if deposited nanomaterials are disturbed. Similar challenges were encountered by the pharmaceutical industry with the advent of high-potency drug products, including the lack of experience in establishing OELs in the low microgram to nanogram/m3 range, no analytical methods to detect exposures to these highly potent molecules, and no marketed containment technology. By developing and implementing a systems-based, PtD strategy, the industry was able to bring these new, life-saving drugs to market.
Working from knowledge that has been developed about the process used to engineer and synthesize new nanomaterials, the preferred laboratory/production facility and process equipment design, the potential health effects from occupational exposure, the environmental fate and effects, and the effective methods for communicating risks and controls to workers in this industry, this project will develop a PtD strategy, similar to the one implemented by the pharmaceutical industry, and related guidance for the safe development, synthesis, product manufacturing, and ultimate disposal and/or recycling of engineered nanomaterials or nanomaterial-containing products. In addition, it will lay the groundwork for the safe design of nanomaterials including moderating toxicity by changing physicochemical parameters and focusing on some of basic science from National Institute of Environmental Health Sciences (NIEHS) "safe by design" and Environmental Protection Agency (EPA) “design for the environment” efforts. Developing the PtD strategy and related guidance requires convening a working group of scientists and practitioners, in a workshop setting, with expertise that includes: PtD; nanomaterials; environmental protection; facility, laboratory, and equipment engineering and performance; occupational health and safety hazard and risk assessment, and employee training and education.
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