1. Update on Revision of DOE Order 456.1, The Safe Handling of Unbound Engineered Nanoparticles DOE and DOE Contractors Industrial Hygiene Meeting in Conjunction with the 2016 American Industrial Hygiene Conference and Exposition Robin Pickens Keeler Industrial Hygienist Department of Energy Office of Worker Safety and Health Policy, AU-11 May 23, 2016

2. Topics Covered IG Audit Report Nano Order 456.1 Revision 2

3. Background: DOE & the NNI The National Nanotechnology Initiative (NNI) is a U.S. Government research and development initiative involving the nanotechnology- related activities of 20 departments and independent agencies 3

4. IG Audit Report Report issued February 2008 Review found twelve laboratories had not fully adopted nanoscale precautionary measures per CDC/NIOSH suggestions. 4

5. Recommendations The Department should establish clear expectations for precautionary measures The Department should adopt and disseminate the best available guidance on nanoscale safety The Department should establish procedures in: medical surveillance exposure monitoring worker training engineering controls 5

6. Implementation of IG Recommendations In response, DOE Order 456.1, The Safe Handling of Unbound Engineered Nanoparticles was issued in May 2011. 6

7. IG Audit – Follow-up Report A follow-up review from the 2008 audit IG visited 4 labs: Brookhaven National Lab Oak Ridge National Lab Los Alamos National Lab Sandia National Lab 7

8. Findings Progress made in ensuring safe handling of nanomaterials 8

9. Findings Nanomaterials labeling Not always followed – 2 of 4 sites visited Transfer and storage containers Equipment (e.g. HEPA vacuum cleaners, local exhaust ventilation systems) 9

10. Findings Inventory Management The Department had not established specific requirements for laboratories to manage and track the inventory of nanomaterials Nanomaterials not accurately managed in chemical inventory systems in three of four sites visited Each site had a procedure that required nanomaterials be maintained in an chemical inventory system…but In inventory, but could not locate In lab, but not in inventory Nanoscale materials not identifiable as a separate category in the chemical inventory system 10

11. Recommendations The Office of Science and NNSA should direct the labs to: Label nanomaterial storage containers and potentially contaminated equipment Update the inventory status of nanoscale chemicals in a timely manner 11

12. Recommendations That the Associate Under Secretary for EHSS “evaluate the feasibility of incorporating a nanoscale chemical management requirement into Department Order 456.1 to ensure laboratories manage their inventories of nanomaterials effectively.” 12

13. Revision Process for O 456.1 2015: Due for 4-year review JM approved in November 2015 AU-11 reached out to labs for discussion Response to IG audit report Other potential changes to the Order 13

14. O 456.1 Revision Process February 2016 – a draft Order submitted to the Directives Review Board Comments received April 2016 Comments reviewed and resolved in RevCom April 2016 (major and suggested) 14

15. O 456.1 Revision Process Final draft prepared based on comments, submitted to the DRB Review of final draft at DRB meeting June 1 15

16. Highlight of Changes PURPOSE. To establish requirements and assign responsibilities for the Department of Energy (DOE), including the National Nuclear Security Administration (NNSA), for activities involving unbound engineered nanoparticles (UNP). This directive ensures that a precautionary approach is utilized to manage UNP whose hazards and exposure data have not been well-defined, and that work involving UNP occurs in a safe and secure manner that protects workers, the public, and the environment. 16

17. Updated & Additional References ISO/TR 13121 (2011), Nanotechnologies - Nanomaterial Risk Evaluation. ISO/TS 12901-1 (2012), Nanotechnologies – Occupational Risk Management Applied to Engineered Nanomaterials – Part 1: Principles and Approaches. ISO/PDTS 12901-2 (2012), Nanotechnologies – Guidelines for Occupational Risk Management Applied to Engineered Nanomaterials – Part 2: The Use of the Control Banding Approach in Occupational Risk Management. 17

18. Updated & Additional References NIOSH Publications Added: Current Intelligence Bulletin 63, Occupational Exposure to Titanium Dioxide (2011). NIOSH, General Safe Practices for Working with Engineered Nanomaterials in Research Laboratories (NIOSH Publication 2012-147). Current Intelligence Bulletin 65, Occupational Exposure to Carbon Nanotubes and Nanofibers (2013). Current Strategies for Engineering Controls in Nanomaterial Production and Downstream Handling Processes (2014). Removed: NSRC Approach to Nanomaterial ES&H (May 2008) 18

19. “UNP” Continued use of “UNP” acronym Further clarification of an UNP ASTM and ISO definitions Added relevant nanoscale particle types include intentionally produced fullerenes, nanotubes, nanowires, nanoropes, nanoribbons, quantum dots, nanoscale metal oxides, nanoplates, nanolayers, and other engineered nanoscale particles 19

20. Functional Area Requirements “Registry” terminology remains ⁻“Maintain a registry of all personnel who meet this Order’s definition of UNP worker in an accessible electronic format” ⁻Registry to include name, job title at time of being designated an UNP worker, brief description of UNP, brief description of the UNP activity, area in which the activity is located Provide the DOE occupational medicine services provider with a copy of or access to the registry Update the registry annually, at a minimum 20

21. Contractor Requirements Document Nanotechnology Policies and Procedures Establish safety and health policies and procedures for activities involving UNP that identify how the contractor will comply with the requirements of this Order. Removed: These policies and procedures should be an integral part of the DOE-approved Worker Safety and Health Program document, required by 10 C.F.R. §851.11 “Development and approval of the worker safety and health program.” 21

22. Posting and Labeling Label storage and transfer containers to plainly indicate the contents include UNP, e.g., “nanoscale zinc oxide particles” or other identifier instead of just “zinc oxide.” If affixing a label is impractical, alternative labeling schemes may be used in lieu of affixing labels, as long as the alternative method clearly identifies the containers to which it is applicable, is readily accessible, and provides information to workers regarding potential hazards. 22

23. Chemical Inventory? Concluded it was not feasible to add this requirement Hazard assessment process identifies potentially hazardous materials, thus requiring implementation of controls to mitigate the hazards. 23

24. Contact: Robin Keeler robin.keeler@hq.doe.gov 301-903-9981 robin.keeler@hq.doe.gov