1. Sampling and Analytical Impacts from Proposed DOE and OSHA Beryllium Regulatory Changes Michael J. Brisson, Savannah River National Laboratory, Aiken, SC, USA Chairperson, Beryllium Health and Safety Committee Sampling and Analysis Subcommittee DOE and DOE Contractors Industrial Hygiene Meeting, Baltimore, MD 23 May 2016 SRNL-MS-2016-00103-S OSHA Items of Interest and First Impressions from DOE NOPR

2. Disclaimers Discussion herein is limited to sampling, analysis, and related issues in the OSHA and DOE proposals. Other issues, such as medical surveillance, labeling, PPE, housekeeping, etc., are not expressly discussed. Views expressed in this presentation are those of the speaker and do not necessarily reflect the views of DOE, SRNL, other DOE sites, or other federal agencies. The presenter does not speak for any federal agency or entity. Mention of commercial products or companies does not imply endorsement or criticism. Nothing in this presentation is intended, nor should it be construed, to represent restraint of trade. 2

3. As You All Know … We expected the Notice of Proposed Rulemaking (NOPR) for revisions to 10 CFR 850 to have been promulgated in Federal Register by now. NEWS FLASH – Secretary of Energy approved NOPR May 16; advance copy is available on DOE CBDPP page (http://energy.gov/ehss/chronic- beryllium-disease-prevention- program-10-cfr-850 )http://energy.gov/ehss/chronic- beryllium-disease-prevention- program-10-cfr-850 Most of this presentation was prepared before NOPR was available, and so is focused on items of interest from the OSHA proposal. Slides have been added at the end with initial thoughts on sampling and analysis impacts from NOPR – based on a very fast scan!! 3

4. Just to Be Clear … A minor revision was promulgated to 10 CFR 851 on 15 November 2015 (80 FR 69564) Intent was to ensure that the PEL would be the only element in present or future OSHA regulations that would apply to DOE or its contractors Technical amendments to Sections 851.2 and 851.23, and Appendix A The logic flows something like this: – §850.22 points to 29 CFR 1910.1000 and the current PEL of 2  g/m 3 – The OSHA proposal (29 CFR 1910.1024) would only apply to general industry, so if adopted as proposed, OSHA will have two PELs, one for general industry (proposed at 0.2  g/m 3 ) and the current one for, e.g., construction and shipyards – §850.22’s provision “or a more stringent TWA PEL that may be promulgated” by OSHA will invoke the lower (29 CFR 1910.1024) PEL – Nothing else in 10 CFR 851 will apply due to the exclusion added to §851.2 4

5. More Disclaimers This next part of this presentation is a summary of comments developed by a group of volunteers within the BHSC Sampling and Analysis Subcommittee. The task group focused on portions of the OSHA proposal related to sampling and analysis or other industrial hygiene considerations, and did not consider portions related to medical surveillance and removal. 5 (reikihealingassociation.com)

6. Subsection (c) and Alternatives 3, 4, and 5 PEL and STEL – PEL of 0.2  g/m 3 (versus current 2.0) – Action level of half the PEL (would be below the current 10 CFR 850 action level) – STEL of 2.0  g/m 3 (15 minute exposure) Task group did not comment on subsection (c) itself Regulatory alternatives 3, 4, and 5 – Alt. 3 would set STEL at five times the PEL – Alt. 4 would set the PEL at 0.1  g/m 3, which would be less than the current 10 CFR 850 action level)  M ORE ON THIS LATER – Alt. 5 would set the PEL at 0.5  g/m 3 – Task group did not support any of these alternatives – felt that the current proposal provided best balance considering available studies, economic factors, and analytical chemistry capabilities 6

7. Subsection (d) and Alternatives 9, 10, 11 Exposure Assessment – Breathing zone samples sufficient to characterize per shift/job class/work area – STEL monitoring when likely to exceed STEL – Analytical accuracy of + 25% at action level NOTE that this gets harder to achieve when the action level gets lower. 10 CFR 850 presently has this requirement, but proposes to eliminate it in lieu of AIHA- LAP, LLC (or equivalent) QA requirements – OSHA does not require accreditation – Initial monitoring required unless representative historical or objective data available – Annual monitoring if initial exposures above AL but below PEL Comments on this subsection – Analytical accuracy requirement poses some challenges (next slides) Regulatory alternatives 9, 10, and 11 – Would call for sampling every 180 days under various scenarios – Task group noted that 180 days would be better than annually, but made no other comment 7

8. Subsection (d) – Analytical Accuracy at Action Level PEL and STEL are based on mass per volume of air, but lab detection is based on mass only (whatever is on the filter) MQL for ICP-AES is 0.03  g/sample; ICP-MS 0.004, fluorescence 0.005 (all based on ASTM standards) – ICP- AES can achieve 0.01 when used with a column separation method Values in red are below all analytical limits; values in yellow are below ICP-AES; values in green are above all limits This does NOT consider reporting limits that may be higher, or samples requiring extra dilution (e.g., due to dust loading), and does NOT consider goal of being able to “see” 10% of an action level (EN 482) Also, samples for PEL compliance will typically be longer than 15 minutes in duration - there is no problem in comparing 15-minute sample against proposed STEL 8 Sampling duration (hr) and resulting volume of air drawn (cubic meters) Sampling Rate (L/min) 0.25 hr (15-minute STEL) 0.5 hr (30-minute STEL) 1.0 hr2.0 hr4.0 hr8.0 hr (conventional TWA interval) 2.00.03 m 3 0.06 m 3 0.12 m 3 0.24 m 3 0.48 m 3 0.96 m 3 3.50.05 m 3 0.10 m 3 0.21 m 3 0.42 m 3 0.84 m 3 1.68 m 3 4.00.06 m 3 0.12 m 3 0.24 m 3 0.48 m 3 0.96 m 3 1.92 m 3 Action Level (AL) AL (µg/m 3 ) Volume of air collected (m 3 ) and resulting mass collected on filter (µg) 0.03 m 3 0.06 m 3 0.25 m 3 0.5 m 3 1.0 m 3 2.0 m 3 Regulatory Alternative 40.050.0015 µg0.003 µg0.013 µg0.025 µg0.05 µg0.1 µg OSHA proposed0.10.003 µg0.006 µg0.025 µg0.050 µg0.10 µg0.2 µg Current DOE0.20.006 µg0.012 µg0.050 µg0.10 µg0.20 µg0.4 µg Regulatory Alternative 50.250.0075 µg0.015 µg0.063 µg0.13 µg0.25 µg0.5 µg

9. Subsection (o) Effective Dates – N + 0 = date final rule is published – N + 60 days = rule takes effect – N + 150 days = rule is enforceable – N + one year = change rooms must be provided – N + two years = required engineering controls must be implemented Comments on this subsection related to analytical considerations – Group was originally concerned that the lead time for labs not having ICP-MS or fluorescence to implement it could exceed 150 days – Accreditation would add to the timeline Accreditation not required under OSHA proposal but is required by 10 CFR 850/851 – However, some commercial labs have ICP-MS in place for beryllium now, and others are going there, so this is less likely to be an issue 9

10. How This Summary Is Organized (Part 2) OSHA Questions – OSHA solicited feedback on 37 questions (beginning at 80 FR 47572) – Task group responded to 13 of these questions – SOME of the responses follow (streamlined for time) 10

11. Question 12 Is it reasonable to allow discontinuation of monitoring based on one sample below the action level? Should more than one result below the action level be required to discontinue monitoring? The task group would not consider a single sample to be a reasonable determination of exposures through monitoring. The task group would propose that a performance-based strategy would replace the specification-based strategy outlined in this proposed regulation. If a performance-based strategy is deemed too difficult to enforce, then the task group would propose that a minimum of six (6) samples (AIHA guidance) to reduce uncertainty in the exposure profile. 11

12. Question 19 (excerpted) Is ‘‘visibly contaminated’’ an appropriate trigger for PPE? Is there reason to require PPE where employees’ skin can be exposed to insoluble beryllium compounds? Please provide the basis for your response and any applicable supporting information. No – analytical data from some DOE sites has shown contamination even when not visible, sometimes exceeding DOE release criteria An increase in surface contamination will increase probability of airborne exposure; however, studies have not established a direct relationship between surface contamination and airborne inhalation exposure 12

13. Question 21 The proposed rule prohibits dry sweeping or brushing for cleaning surfaces in beryllium work areas unless HEPA-filtered vacuuming or other methods that minimize the likelihood and level of exposure have been tried and were not effective. Please comment on this provision. What methods do you use to clean work surfaces at your facility? Are HEPA-filtered vacuuming or other methods to minimize beryllium exposure used to clean surfaces at your facility? Have they been effective? Are there any circumstances under which dry sweeping or brushing are necessary? Please explain your response. Dry sweeping should never be used for beryllium; it will disturb settled dust and can exacerbate airborne contamination. If dry wiping is absolutely necessary, use a dry wiping cloth (example: SymWipe™) HEPA vacuuming, while considered to be the most effective method for cleaning surfaces, is not necessarily effective in minimizing the spread of contamination. If OSHA were to prescribe HEPA filtered equipment use, it would be wise to include a demonstrated monitoring plan of particle counting during use. Sites use wet wiping methods, dry wiping using specialized cloths, and HEPA vacuuming. Wet methods are effective on settled Be dust; HEPA vacuuming is effective on settled dust and capturing fugitive Be dusts at the point of generation. 13

14. Question 22 The proposed rule requires that materials designated for recycling that are visibly contaminated with beryllium particulate shall be cleaned to remove visible particulate, or placed in sealed, impermeable enclosures. However, small particles (<10  g) may not be visible to the naked eye, and there are studies suggesting that small particles may penetrate the skin, beyond which beryllium sensitization can occur (Tinkle et al., 2003). OSHA requests feedback on this provision. Should OSHA require that all material to be recycled be decontaminated regardless of perceived surface cleanliness? Should OSHA require that all material disposed or discarded be in enclosures regardless of perceived surface cleanliness? Please provide explanation or data to support your comments. Task group believes that only items that are intended to remain onsite or scheduled to be used at another facility that has established beryllium regulated areas (and will be used in these regulated areas) can be considered for recycling. Items that cannot be cleaned to DOE housekeeping limit (3  g/100 cm 2 ) should be discarded and disposed appropriately. 14

15. DOE NOPR – Airborne Action Level (§850.23) Proposes airborne action level of 0.05  g/m 3 – Matches ACGIH® TLV® but does not invoke inhalable fraction – Requirement for accuracy of +25% at action level would be eliminated – DOE has specifically requested comment on this proposal – Two-thirds of pre-NOPR commenters did not agree with this proposal – DOE believes that the lower action level will require the use of new or different types of equipment, but that may not be entirely the case for analytical labs that do not already have ICP-MS or fluorescence – At 2 L/min, at least 1 hr of sample at 0.05  g/m 3 (or 0.12 m 3 ) is needed to obtain a reportable quantity – Amount of beryllium regulated areas across DOE could increase considerably 15 Action Level (AL) AL (µg/m 3 ) Volume of air collected (m 3 ) and resulting mass collected on filter (µg) 0.03 m 3 0.06 m 3 0.12 m 3 0.25 m 3 0.5 m 3 1.0 m 3 DOE proposed/OSHA R.A. 4 0.050.0015 µg0.003 µg0.006 µg0.013 µg0.025 µg0.05 µg OSHA proposed0.10.003 µg0.006 µg0.012 µg0.025 µg0.05 µg0.10 µg Current DOE0.20.006 µg0.012 µg0.024 µg0.050 µg0.10 µg0.20 µg OSHA R.A. 50.250.0075 µg0.015 µg0.030 µg0.063 µg0.13 µg0.25 µg

16. DOE NOPR – Portable Laboratories Modified §850.24 would: – permit use of field or portable laboratories that are accredited in an AIHA-LAP, LLC or equivalent QA program that addresses field/portable lab analysis DOE expects cost savings from use of field or portable laboratories – allow employers to use results that are below laboratory reporting limits DOE believes this would enhance the usefulness of these results for determining if specified levels are exceeded Issues: – AIHA Registry Programs LLC (not AIHA-LAP, LLC) has drafted a suitable program for field/portable laboratories but funding is needed to launch the first-year pilot – In absence of the registry program, AIHA-LAP, LLC accreditation is costly – Accreditation programs do not allow laboratories to provide results below laboratory reporting limits without a data qualifier that removes them from accredited scope 16

17. DOE NOPR – Changes in Definitions (§850.3) Definitions for “beryllium”, “beryllium worker”, and “beryllium affected worker” would be changed – Soluble forms and mineral forms of beryllium would no longer be regulated Lack of evidence of health effects associated with these forms DOE expects some cost savings as a result – OSHA does not define these terms – DOE specifically requests comments on these changes, and information on different forms of beryllium and their health effects Issues – Typical laboratory analysis does not distinguish the form of beryllium (requires XRD) – Lab results therefore could include soluble and insoluble forms of beryllium Minerals less likely to be an issue since more aggressive dissolution is required – A way to distinguish has long been desired, but needed R&D has not been funded 17

18. DOE NOPR – Surface Sampling (§850.24a) Wet wiping will now be required except: – When surface would be damaged by wetting; dry wipes allowed in this case – When surface is textured (i.e., rough); vacuum sampling allowed in this case – When there is too much material; bulk sampling allowed in this case Surface sampling no longer required on interior surfaces of closed systems (e.g., gloveboxes, chambers, normally inaccessible surfaces) 18

19. DOE NOPR – Release and Transfer Criteria (§850.31) For unconditional release: – Proposal distinguishes between surface level of beryllium (must now be <0.2  g/100 cm 2 ) and bulk material on surface (must be lower than soil concentration at point of release) – This could be tricky to distinguish in some cases Release of “areas” (e.g., real property, buildings, work areas) added – Criterion is 0.2  g/100 cm 2 19

20. Questions or Comments? 20 Thanks for your attention!