1、Institute of Environmental Sciences and Technology IEST-RP-NANO205.1 Contamination Control Division, Nanotechnology Committee Recommended Practice 205.1 Nanotechnology Safety: Application of Prevention through Design Principles to Nanotechnology Facilities Arlington Place One 2340 S. Arlington Heigh
2、ts Road, Suite 620 Arlington Heights, IL 60005-4510 Phone: (847) 981-0100 Fax: (847) 981-4130 E-mail: informationiest.org Web: www.iest.org 2 IEST 2016 All rights reserved Institute of Environmental Sciences and Technology IEST-RP-NANO205.1 This Recommended Practice was prepared by and is under the
3、jurisdiction of Working Group 205 of the IEST Contamination Control Division Standards also see section 5.2.1(d4) of this RP. 5 PLANNING FOR ENVIRONMENTAL HEALTH AND SAFETY CAUTION: It is beyond the scope of this RP to provide planning for all of the potential safety issues associated with the desig
4、n and operation of nanotechnology facilities. Relevant safety standards, national and local regulations, and building codes must be consulted when designing facilities and developing safety plans and training programs. 5.1 Contents of a safety plan As with any technology facility, nanotechnology fac
5、ilities require a systematic design process that considers applicable regulations as well as the best information available on the properties of the materials to be used on the premises and characteristics of the planned processes or operations. A nanotechnology EHS program should address, at a mini
6、mum, the following elements: Design considerations (see 5.2 for details) Identification of potential hazards Assessment of risks Design and hierarchy of appropriate controls Design, layout, and zoning considerations IEST-RP-NANO205.1 Institute of Environmental Sciences and Technology IEST 2016 All r
7、ights reserved 16 Codes and standards considerations Emergency planning Operational considerations (see 5.3 for details) Documentation Institutional review of processes and practices Incident reviews and audits Medical surveillance Training It is critical that any EHS program have support at all lev
8、els of leadership. Support from upper management allows the proper allocation of resources and sets the tone throughout the organization. This implies the involvement and knowledge of all levels of staff and mid-level management in these programs. In the same vein, safety training should be provided
9、 at all levels of the organization. The depth of the training may vary by level and function, but it is important that safety training be conducted at all levels (see section 12). It is also important that the personnel working in the facility play a role in safety protocol development. Protocols th
10、at restrict personnel in their work are counterproductive. Not only will such protocols be violated, but they will send the message that violation of approved protocols is acceptable. Part of the job description of all personnel should include the support of safety policies and programs. This requir
11、ement should be addressed in the performance evaluation of all personnel. 5.2 Design considerations 5.2.1 Identification of potential hazards Although emerging nanomaterials have gained attention because of their novelty, other materials, biologicals, chemicals, and sources of hazards also should be
12、 identified. Facility designers should work with a team that represents safety, process-engineering (chemical, biological, radiological, nanotechnology), maintenance, and security personnel to develop a comprehensive, written hazard analysis that considers the following approaches for classifying ev
13、ery substance expected to be used or generated in the facility. A designated internal or external expert who will review every step of the process for hazards should be included on the design team. OSHA defines hazardous and toxic substances as those chemicals present in the workplace which are capa
14、ble of causing harm. The term chemicals includes dusts, mixtures, and common materials such as paints, fuels, and solvents. As an example, the Indiana Fire Code defines hazardous material as “A solid, liquid, or gas associated with semiconductor manufacturing that has a degree-of-hazard rating in he
15、alth, flammability, or reactivity of Class 3 or 4 as ranked by the UFC Standard 79-3 and which is used directly in research, laboratory or production processes which have as their end product materials which are not hazardous.” This definition is implied when the term hazardous materials is used in
16、this document. In the US, the Environmental Protection Agency (EPA) administers the Toxic Substances Control Act, which pertains to substances that may present unreasonable risk to human health or the environment. These regulations apply to newly created materials and must be followed if a material
17、is to be introduced into the US marketplace. Nanomaterials present new challenges when establishing hazard classifications because hazards are unknown or differ from those associated with the larger particle size configuration of the same material. Hazards associated with the chemical reactivity of
18、a nanomaterial should be determined and documented to achieve the proper handling and storage of all nanomaterials (see sections 6 and 7). Chemical reactivity hazards of nanomaterials include the formation of highly reactive energetic powders (e.g., nano-sized aluminum powder). a) Toxicity A key fac
19、tor in the risk assessment of a facility is the determination of the toxicity of materials in question by appropriate methods. US Department of Health and Human Services toxicology tutorials I, II, and II (including definitions of terms) can be found at http:/sis.nlm.nih.gov/enviro/toxtutor.html. IE
20、ST-RP-NANO205.1 Institute of Environmental Sciences and Technology IEST 2016 All rights reserved 17 b) Chemicals Chemical hazards include all physical states of a chemicalsolid, liquid, gas, plasma, colloid, aerosol (fume, vapor, or mist). The hazards also apply independent of particle or droplet si
21、ze (i.e., macro-, micro-, or nanoscale) or morphology (e.g., particle, fiber, platelet). It should also be noted that the hazard related to a material may change based on these properties. Chemical risks in a nanotechnology facility are not substantially different from chemical risks in other high-t
22、echnology facilities. The principal source for risk analysis and chemical hazards is the SDS for each chemical used in the facility. In addition to the hazard information, the SDS will provide information on safe use of the chemical, safeguards to be implemented when using the chemical, and recommen
23、ded PPE. Further information and guidance can be found from the following reference documents: NFPA 318 Toxic Gas Ordinance NIOSH Pocket Guide to Chemical Hazards NIOSH (2014e) Saxs Dangerous Properties of Industrial Materials Guides and handbooks furnished by chemical suppliers c) Biohazardous mate
24、rials Materials (including background materials) from outside sources and internal processes can include live biological material that may constitute a biological hazard. Biological hazards may pose threats to human, animal, or plant health. The facility design and operational protocols should inclu
25、de safety control measures that eliminate or reduce these risks, where present, to acceptable levels. Biological hazards related to nanotechnology facilities fall into two categories: 1. Conventional biologically active materials. The hazards related to conventional materials are well understood, an
26、d dealing with these materials is well documented in Biosafety in Microbiological and Biomedical Laboratories (BMBL) as described later in this section. 2. Bio-activated nanomaterials. These materials present a different set of problems because the transport properties of nanomaterials allow them to
27、 interact with the human body in different ways than larger materials. Additionally, the toxicological properties of some materials change in the nanoscale regime. The potential exists to create systems that challenge natural biological defenses, thereby increasing the biological activity and subseq
28、uent hazards from materials that are less hazardous in larger sizes. It is imperative that a careful risk assessment be performed for these innovative materials early in the research, development, and manufacturing cycle. For information on assessing biological hazard risk and incorporating facility
29、 design measures, refer to the BMBL. The BMBL defines different levels of protection, named biological safety levels (BSL), depending on the level of risk posed by the biological hazard. BSL levels incorporate operator practices, engineering controls, and facility design measures into an integrated
30、system of protection. The biological safety levels are defined in BMBL as follows: Biosafety Level 1 (BSL-1) is suitable for work involving well-characterized agents not known to consistently cause disease in immunocompetent adult humans, and which present minimal potential hazard to laboratory pers
31、onnel and the environment. BSL-1 laboratories are not necessarily separated from the general traffic patterns in the building. Work is typically conducted on open bench tops using standard microbiological practices. Special containment equipment or facility design is not required, but may be used as
32、 determined by appropriate risk assessment. Laboratory personnel should have specific training in the procedures conducted in the laboratory and should be supervised by a scientist with training in microbiology or a related science. Biosafety Level 2 (BSL-2) builds upon BSL-1. BSL-2 is suitable for
33、work involving agents that pose moderate hazards to personnel and the environment. It differs from BSL-1 in that 1) laboratory personnel have specific training in handling pathogenic agents and are supervised by scientists competent in handling infectious agents and associated procedures; 2) access
34、to the laboratory is restricted when work is being conducted; and 3) all procedures in which infectious aerosols or splashes may be created are conducted in biological safety cabinets (BSCs) or other physical containment equipment. Biosafety Level 3 (BSL-3) is applicable to clinical, diagnostic, tea
35、ching, research, or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through IEST-RP-NANO205.1 Institute of Environmental Sciences and Technology IEST 2016 All rights reserved 18 inhalation route exposure. Laboratory
36、personnel must receive specific training in handling pathogenic and potentially lethal agents, and must be supervised by scientists competent in handling infectious agents and associated procedures. Biosafety Level 4 (BSL-4) is required for work with dangerous and exotic agents that pose a high indi
37、vidual risk of life-threatening disease, aerosol transmission, or related agent with unknown risk of transmission. Agents with a close or identical antigenic relationship to agents requiring BSL-4 containment must be handled at this level until sufficient data are obtained either to confirm continue
38、d work at this level, or re-designate the level. Laboratory personnel must have specific and thorough training in handling extremely hazardous infectious agents. Laboratory personnel must understand the primary and secondary containment functions of standard and special practices, containment equipm
39、ent, and laboratory design characteristics. All laboratory personnel and supervisors must be competent in handling agents and procedures requiring BSL-4 containment. Access to the laboratory is controlled by the laboratory supervisor in accordance with institutional policies. d) Nanomaterials This R
40、P does NOT address toxicity and other hazards of specific nanomaterials. Issues of safety (toxicity) of nanomaterials have not reached a consensus. This lack of consensus represents a significant knowledge void that should be considered. Such issues include, but are not limited to, exposure, dose, a
41、bsorbency, absorbency rate, and developments at the molecular/cellular level in terms of toxicity, mutagenicity, carcinogenicity, teratogenicity, and metabolic anomalies. In addition to the estimated toxicity of the nanomaterial, other properties might include the quantities of materials used and th
42、e dustiness of the material. Dustiness is the amount of material aerosolized in a laboratory test when subjected to mechanical energy typical of industrial dust handling processes (EN 15051:2006). Several studies have been undertaken to develop approaches to classification of nanomaterials in an eff
43、ort to define risk. 1. Estimation approach See Schlte et al. (2010). 2. Controlled banding See NIOSH (2009c), (2014c), (2014d); Schulte et al. (2008). A controlled banding standard has been published for nanomaterials (ISO/TS 12901-2:2014) and a number of software packages were available to assist i
44、n the estimations (Paik et al., 2008). 3. Published guidance The literature should be closely monitored for the latest information on materials planned for use in the facility. For example, NIOSH (2011b) recommends concentration limits for inhalation exposure of nanomaterials. NIOSH recommends airbo
45、rne exposure limits of 2.4 mg/m3 for fine TiO2 and 0.3 mg/m3 for ultrafine (including engineered nanoscale) TiO2, as time weighted average concentrations for up to 10 hr/day during a 40-hr work week. Recently, a detailed compilation of the current information on carbon nanotubes and nanofibers becam
46、e available in NIOSH (2013d). Carbon nanotubes and nanofibers have been a concern of the toxicological research community due to shape and insolubility, and because metal catalysts from synthesis may be incorporated in the material. NIOSH has set a recommended exposure limit (REL) of 1 g/m3 for inha
47、lation, which corresponds to the detection limit of measurement. 4. Novel pathogens For materials whose toxicological or bio-contaminating properties are well documented in the BMBL, the recommended guidelines for safety should be employed. In many cases, however, the specific hazards and toxicities
48、 are unknown due to the differences in configurations of the material. Nanomaterials can be created in various forms and particle sizes. Per the NIOSH references in (2) and (3), a nanomaterial may not have the same hazardous characteristics as larger particle size configurations of the same material
49、; therefore, toxicological studies of larger (non-nano) materials should not be relied on. In cases where the hazardous characteristics are unknown but are likely to be significant, the material should be considered as a novel pathogen and dealt with appropriately. When assessing the hazard level of a novel IEST-RP-NANO205.1 Institute of Environmental Sciences and Technology IEST 2016 All rights reserved 19 material, the worst case for all applicable parameters should be applied. For example, in the case of a biological hazard, a novel patho
