1. 1 OSHA’s Approach to Nanotechnology: Developing a Searchable "Health Effects Matrix" Database for Nanomaterials Utilizing Existing Published Data Janet Carter Sr. Health Scientist Department of Labor Occupational Safety & Health Administration Directorate of Standards and Guidance

2. 2 Presentation Outline Brief overview of OSHA perspective on nanotechnology Highlights of OSHA activity Specifics on “Health Effects” matrix 1

3. OSHA’s Mission … “assure safe and healthful working conditions for working men and women”… 3 2

4. Nanomaterials – highly diverse in form, structure, chemistry 4 Source: Maynard et al., 2005 3

5. 5 Many Applications for Nanotechnology Every day uses such as sunscreens Electronic and Information Technologies Sustainable Energy Applications Environmental Remediation Nanobiosystems, Medical, and Health Applications 4

6. OSHA’s Interest in Nanomaterials Various studies suggest some nanomaterials may be toxic to workers –Effects may be dependent on size, crystalline structure, solubility, shape, chemical form, other characteristics –Not necessarily relatable to macro-scale material of same chemical composition –Many unknowns remain 6 5

7. 7 What is known about nanomaterials Small, insoluble particles may be more toxic than large particles on a mass basis Small particles may distribute beyond portal of entry Distributed particles may have different organ distribution and clearance than soluble materials 6

8. 8 What is Not Known How to predict potential for novel mechanisms of toxicity How to predict extra-pulmonary particle distribution, clearance based on physico/chemical properties High to low dose extrapolation methods Sensitive subpopulations-range of sensitivity Consequences of distribution and long term residence in brain, liver, spleen, bone marrow, including data on bench-mark compounds or screening methods for hazard ranking 7

9. 9 Not all nanomaterials are alike Source: Maynard et al., 2005 8

10. 10 OSHA’s conundrum Small agency Small budget in comparison to other Federal agencies with nano programs Scarce and/or inconsistent information –Cannot treat all nanomaterials as same Proactive on safety and health issues without hindering or stifling innovation or job-growth 9

11. 11 OSHA’s Objective for Nanotechnology Protect workers Promote safe sustainable stewardship of nanotechnology Promote collaboration between Federal Partners, Industry and Labor 10

12. 12 OSHA’s Approach to Nanotechnology Utilize existing framework Work through National Nanotechnology Initiative (NNI) Form collaborations with Federal agencies, NGOs, Industry, Labor organizations Develop Agency specific programs 11

13. 13 OSHA Program Activities Develop guidance materials and information for workers and businesses to promote sustainable occupational practices Develop bibliographic database of peer- reviewed EHS publications - “Health Effects Matrix” –Possible hazard determination guidance –Possible SAR development 12

14. 14 Nanomaterials Health Effects Matrix Focus on existing published data Searchable and sortable format –Highlight similar effects Develop SAR for nano? Develop hazard determination criteria –Safety data to be included Information to be publically available –Venue not determined yet Publish in peer-review journal Public access on website 13

15. 15 Literature Search Findings To date: –Over 700,000 Nanotechnology publications (according to Web of Science) –Close to 32,000 studies have been published and available through NLM/PubMed More than 3300 are review articles –More than 4000 studies of those on nanomaterial/nanoparticle toxicity More than 2100 studies focused on human toxicity –Approximately half studies conducted using in vitro systems –More than 20 different broad categories of materials tested –More than 500 of these publications are review Approximately 1100 studies have been identified as having usable information for our database 14

16. 16 Distribution by Study Compounds 15

17. 17 Information Collection for Database Full reference information Biological effect –System/organism –Delivery system –Vehicle –Full test info –Species –Study duration –Dose – with corresponding biological response for each endpoint –Quantitative –Qualitative –Sample size –How was material dispersed agents or actions Materials –Chemical composition –Size Principle (mean) Distribution Agglomeration state –Surface area –Structure –Solubility –Manufacturer, producer, laboratory of nanomaterial –Contaminants –Other information Scans Certificate of analysis MSDS 16

18. 18 Example of Database Entry: 17

19. 19 Preliminary Findings Labor intensive process Iterative process Most EHS data generated from 1 st generation nanoparticles and CNTs –Are a few exceptions R&D work on 3 rd generation nanomaterials –Very early stage research for 3 rd generation –2 nd generation near market stage 18

20. 20 Preliminary Conclusions Data is more usable than many critics say Trends are emerging –Able to make some preliminary determinations on apparent “inconsistencies” in the literature Highlights to need for more consistency in how research is conducted –Not unique to nanoresearch Can be used as tool to develop future research needs by systematically highlighting current gaps in research/knowledge 19

21. 21 Future Direction of Project Anticipate completely preliminary results by end of August 2012 Possible publication by fall/winter (if accepted in journal) Update database utilizing new search criteria early 2013 Share database to other communities after formal clearance 20