oh2016 25 - 28 april 2016 glasgow, scotland · oh2016 25 - 28 april 2016 glasgow, scotland. session...
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AIHA Fall Conference Template
The Chartered Society for Worker Health Protection
OH2016 25 - 28 April 2016 Glasgow, Scotland Session 3c
Nanotechnology Tuesday, April 26, 2016
Nanoscale Titanium Dioxide in Cosmetics: Is Everything Beautiful?
Jacob Persky, MPH, CIH Fred W Boelter, CIH, PE, BCEE, FAIHA
RHP Risk Management Inc.
Exposure Science
Law Policy
Regulations
Business
Technology
Product Safety Cosmetics & Personal Care Products
Manufacturing
Titanium Dioxide in Cosmetics
REACH DNELs EU cosmetics directive
FDA USP NIOSH REL
Prop65 NSRL
Listing published January 2011 WHO/IARC – Group 2B (possibly carcinogenic to humans)
Prop Listing applies to: “Airborne, unbound particles of respirable size”
Listed in 2011
Violation Notice Issued in 2013
No Significant Risk
CALIFORNIA PROPOSITION 65 WARNING
WARNING: This product contains chemicals known to the State of
California to cause cancer.
Regulatory Requirement Options:
• Reformulate • Remove from Commerce
• Hazard Warning Label • Risk Determination
California Office of Environmental Health Hazard Assessment
Warning label exemption if exposure from typical product use poses no significant risk of cancer. Meaning: • < 1 excess cancer in 100,000 individuals exposed over a
70-year lifetime. (<1E-5) • Regulations identify specific “No Significant Risk Levels”
(NSRLs) for many listed carcinogens… but not TiO2
Cancer slope factor Epidemiology
Toxicology
Exposure Science
Derive NSRL Conduct Quantitative Exposure Assessment
Definition of “No Significant Risk”
Detection. The first hurdle.
• Exposure Assessment: Detectable?
“Knowingly and intentionally exposed persons to a listed chemical without providing clear and reasonable warning.”
• Must demonstrate prima facie exposure potential.
When bringing action against a manufacturer, it is the plaintiff’s burden to demonstrate exposure is detectable. This is not a risk-based approach, it is a function of analytical methodology and LODs.
Yes. Use risk-based approach.
No. No action required.
Exposure Assessment Challenge
Develop an exposure assessment strategy which will withstand scientific scrutiny, absent a NSRL criterion value.
No “knowing and intentional exposure” occurs if: • A method of detection and analysis is applied
concerning an alleged exposure. • Methods of detection and analysis that may be
relied on include: FDA, USEPA, OSHA, NIOSH, CPSC, etc.
• Select “most sensitive” method of detection / analysis • All reported results must show that the chemical
in question was not detected.
Criteria
Most Sensitive Validated Method
NIOSH REL 2.4 mg/m3
for fine TiO2
0.3 mg/m3 for ultrafine TiO2
RISK at REL
1 in 1,000 excess cancer risk criteria • 8-hr TWA
• ≤10 hours/day • 40 hours/week
• 45 year working lifetime
NIOSH Method 7300. ICP-AES RL = < 0.000834 mg/filter
April 2011
Cancer Risk Time Adjustment NIOSH REL Parameters • Occupational • 40 hrs/week
• 45 yr working lifetime exposure duration
• Acceptable risk level at 1:1,000
NSRL Derivation Parameters • Consumer Product Use • ~4 minutes per application;
0.3-1.3 applications per day (face-powder) (0.1 – 0.6 hrs/week)
• 70 yr life expectancy
• Acceptable risk level at 1:100,000
Collect two side-by-side respirable dust samples. One on a PVC filter and the other on a MCEF filter.
START
Analyze the PVC filter by both gravimetric (NIOSH
0600) and ICP-AES (NIOSH 7300) methods.
No further action.
Analyze duplicate MCEF sample by electron microscopy (TEM) for
TiO2 particle size distribution.
Determine mass TiO2 concentration of fine and ultrafine.
Respirable TiO2 detected.
Respirable TiO
2 not detected.
Product Categories
Assessed application-related exposures to 5 products representing 4 consumer product categories.
Eye Shadow
Face Powder
Sunscreen powder Nail Powder
Blush
Exposure Assessment Chamber
• Study conducted in 10’x17’x8’ isolation room.
• Protect testing environment from outside interferences.
• Dressing table with mirror and chair for product application.
• HEPA-filtered air to purge room air between test scenarios. (off during testing)
Strategy: Respirable Particulate
• Task duration, personal breathing zone air sampling.
• 2 side-by-side samples with particle-size selective samplers (BGI GK 2.69 cyclone) attached to filter-cassette. – Sample #1
Respirable fraction of airborne dust. NIOSH 0600 – Respirable dust. NIOSH 7300 – Total titanium as TiO2.
– Sample #2 Respirable fraction of airborne dust. Electron microscopy for particle size distribution analysis.
Study Participants Participant A
– Industrial hygienist
– Uses consumer products
– Subject for eye shadow, face powder, blush, and sunscreen tests.
Participant B
– 25-yr salon professional
– Uses products personally
– Applies product professionally
– Nail powder test subject
Product Mass Balance Pre- and post-application mass measurement of
product container and applicator.
Gravimetric Results for Respirable Dust (NIOSH 0600)
All results “Non-Detect”. Results shown as < Reporting Limit.
Test Replicate
Eye Shadow (mg/m3)
Face Powder (mg/m3)
Blush
(mg/m3)
Sun Screen (mg/m3)
Nail Powder (mg/m3)
A < 1.70 < 1.70 < 2.38 < 1.08 < 0.178
B < 1.70 < 1.19 < 2.38 < 1.32 < 0.265
C < 1.70 < 1.70 < 1.70 < 1.32 < 0.313
D -- -- < 1.70 -- --
Differences in reporting limits within and across products reflect variability in duration of product application and difference in the total sampling time.
ICP-AES Results for Respirable TiO2 (NIOSH 7300) §
All results “Non-Detect”. Results shown as < Reporting Limit.
Test Replicate
Eye Shadow (mg/m3)
Face Powder (mg/m3)
Blush
(mg/m3)
Sun Screen (mg/m3)
Nail Powder (mg/m3)
A < 0.0284 < 0.0284 < 0.0397 < 0.0181 < 0.00296
B < 0.0284 < 0.0199 < 0.0397 < 0.0221 < 0.00441
C < 0.0284 < 0.0284 < 0.0284 < 0.0221 < 0.00523
D -- -- < 0.0284 -- --
Difference in reporting limits within and across products reflect variability in the duration of product application and difference in the total sampling time. § Values shown are mass-balance adjusted to represent TiO2 concentrations based upon elemental Ti analysis.
Conclusions
• Exposure assessment study design absent a criterion for data interpretation presents a significant challenge.
• A defensible exposure assessment strategy may be developed based upon relevant toxicological data coupled with realistic exposure factors.
• Risk-assessment is translatable. i.e. Prop65 exposure assessment that meets data quality objectives may find application to REACh.
Thank You.
Jacob Persky, MPH, CIH RHP Risk Management Inc. Chicago, Illinois, USA [email protected] +1 773 867 6001
Fred W Boelter, CIH, PE, BCEE, FAIHA RHP Risk Management Inc. Boise, Idaho, USA [email protected] +1 208 258 7478
Presenters note: Mr. Persky was the Project Manager for this TiO2 study while both he and Mr. Boelter were employed by ENVIRON International Corporation.