CERTIFICATE OF ANALYSIS

Chain of Custody: 305281 Job Name: Task 2 ‐ Analysis of Demonstration Samples Date S

Client: US Food & Drug Adminitration Job Location: Talc (x000756) A TK4428 FDA Date 

Address: Office of Cosmetics & Colors Job Number: Not Provided Re

4300 River Road PO Number: HHSF223201810337P Date 

College Park, MD 20740 Person S

Attention: John Gasper 

Summary of Analysis

% Total Tremolite and TEM LOD TEM LOQ % Tremolite by TEM % Chrysotile by TEM Chrysotile by TEM % AMA Client % % Acid 

Asbestos 

Sample ID Sample ID Using ASTM D5756 Mass Using ASTM D5756 Mass Using ASTM D5756 Mass Using ASTM D5756 Mass Using ASTM D5756 Mass Organics Soluable 

by PLM Calculation Calculation Calculation Calculation Calculation

(b) (6)

3

305281‐4 D‐30 0.00001074% 0.00004295% 15.49345% ND 15.49345% ND 9.4% 46.0% 

305281‐4A D‐30 0.00000519% 0.00002076% 1.82317% ND 1.82317% <0.13% 8.4% 41.2% 

305281‐4B D‐30 0.00000712% 0.00002848% 4.32456% ND 4.32456% ND 8.9% 41.7% 

305281‐5 D‐31 0.00000161% 0.00000644% 0.24245% 0.00183% 0.24429% <0.18% 13.4% 14.7% 

305281‐5A D‐31 0.00000229% 0.00000916% 0.26810% 0.00035% 0.26845% <0.18% 13.7% 13.5% 

305281‐5B D‐31 0.00000117% 0.00000468% 0.20999% 0.00012% 0.21011% <0.18% 13.5% 13.7% 

(b) (6)

LOD = Limit of Detection LOQ = Limit of Quantification ND = Not Detected PLM = Polarized Light Microscopy TEM = Tran

Analytical Method(s): PLM by Modified NY ELAP 198.6

TEM by Modified NY ELAP 198.4/ASTM D5756

Analyst(s): PLM

TEM

Technical Director: Andreas S

(b) (6) (b) (6)

All results are to be considered 

signed by the Technical Direct

This report applies only to the sample, or samples, investigated and is not necessarily indicative of the quality or condition of apparently identical or similar products. As a mutual protection to clients, the public, and these Laboratories, this report is submitted and acc

addressed and upon the condition that it is not to be used, in whole or in part, in any advertising or publicity matter nor shall it be reproduced, except in full, without prior written authorization from us. Sample types, locations, and collection protocols are based upon 

and, unless collected by personnel of these Laboratories, we expressly disclaim any knowledge and liability for the accuracy and completeness of this information. Residual sample material will be discarded in accordance with the appropriate regulatory guidelines, un

applies only to polarized light microscopy of bulk samples and transmission electron microscopy of AHERA air samples. This report must not be used to claim, and does not imply product certification, approval, or endorsement by NY ELAP,AIHA, NVLAP, NIST, or any ag

Analytical Services, Inc.

4475 Forbes Boulevard • Lanham, MD 20706 • (301) 459‐2640/(800) 346‐0961 • www.amalab.com 
 

 

 

Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-4, 4A, 4B/D-30 

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COC 305281, Revision 2 

305281-5, 5A, 5B/D-31 

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COC 305281, Revision 2 

(b) (6)

(b) (6)

Sample Preparation for Samples 305281-3 through 305281-6: 

Samples were prepared for PLM and TEM bulk analysis by 

(b) (6)

on December 27, 2018 through January 7, 2019. 

Sample preparation consisted of the following steps: 

1) Label and weigh a single 8mL glass vial for each sample in the set. 

2) Weigh out 0.5 to 0.8 grams of material and place in corresponding 8mL glass vial. Record weight. 

3) Burn samples at 480° C for at least 12 hours. 

4) Record Post-Ash Weight. 

5) Treat ashed sample with concentrated hydrochloric acid. 

6) Filter acid washed material onto a pre-weighed 47mm 0.4um PolyCarbonate filter. 

7) Place filter into drying oven for 30 minutes and then record Post-Acid Wash weight. 

8) Place filter into corresponding 100ml jar. 

9) Make four slide preparations for each sample from the filter residue in 1.550 dispersion oil for PLM analysis. 

Make additional preparations in 1.605, 1.625, 1.680 and/or 1.700 dispersion oil if necessary. 

10) Weigh a portion of the residue and place it in a 2nd 100ml jar. 

11) Fill the 100ml jar with deionized water 

12) Sonicate the jar for approximate 5-minutes. 

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COC 305281, Revision 2 

13) Filter 0.2ml to 1ml of the solution onto a 47mm 0.22um MCE filter. 

14) Dry the filter for 10 minutes then collapse, carbon coat, and place on a 3 TEM grids. 

PLM Analysis for Samples 305281-3 through 305281-6: 

Analysis was performed in accordance with NY ELAP 198.6 protocols. The analysis was conducted using an Olympus BH2 polarized light microscope (PLM) equipped with a dispersion staining objective. All four slide preparations for each 

aliquot were examined. 400-point count was performed for those samples on which asbestos was observed. If no 

asbestos was detected on any of the slides, the percentage of fibrous components were determined by visual 

estimation. The results of this analysis are detailed below in the Discussion and Interpretation of Analytical Findings 

section for each individual sample. 

TEM Analysis for Samples 305281-3 through 305281-6: 

Analysis was performed in accordance with modified NY ELAP Method 198.4 protocols. The analysis was performed 

using a JEOL JEM-100CX II transmission electron microscope (TEM), equipped with a Thermo Fisher Quest Energy 

Dispersive X-Ray Analyzer (EDXA), at magnifications of 19,000x. Two grids for each aliquot were examined. 20 grid 

openings were examined per sample. 

Modifications to the NY ELAP 198.4 Method were: 

1) The residue was not placed in alcohol and prepared using the quick drop method. To obtain a more uniform 

preparation, the residue was placed in a jar and filled with 100ml of deionized water. The jar was sonicated and a 

portion of the solution was filtered onto a 47mm 0.22um MCE filter. 

2) The tremolite and chrysotile were not visually estimated. The length and width of the observed particles were 

measured and the mass of each amphibole particle was calculated using the ASTM D5756 and ISO 22262-2 

methods. For chrysotile the ASTM D5756 equation was used to calculate the mass. All particles identified as 

asbestos were included with the counts/concentrations, regardless of size or whether or not they would be 

considered “asbestiform.” 

The results of this analysis are detailed below in the Discussion and Interpretation of Analytical Findings section for each 

individual sample. 

Calculations 

ASTM D5756 Mass 

M = π/4 L * W2 * D * 10-12 

ISO 22262-2 

M(g) = L * W * 1⁄2W * D * 10-12 

M = mass 

L = length 

W = width 

D = density 

Percent Calculation 

EFA(mm2

) * 100ml * MA(g) * RW(g) 

VF(ml) * IW(g) * AA(mm2

) * RJ(g) 

The calculated value is then multiplied by 100 to convert it to percent. 

EFA – Effective filter area 

MA – Mass of asbestos 

RW – Weight of residue 

VF – Volume filtered 

IW – Initial weight of the sample 

AA – Area analyzed 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-4, 4A, 4B, Client Sample D30 

PLM 

All three aliquots of sample D30 were analyzed by on January 31, 2019. Tremolite was observed 

on aliquot 4a but no points were counted. No tremolite was detected on 4 and 4b. No other asbestos was detected. 

(b) (6)

305281-4 NAD 

305281-4A <0.13% Tremolite detected 

305281-4B NAD 

305281-4A Tremolite 100x 

TEM 

Sample 4 was analyzed by on January 11, 2019. Samples 4A and 4B were analyzed by

 on January 25, 2019 and January 31, 2019 respectively. Talc is the main constituent in all three aliquots. The 

(b) (6)(b) (6)

talc is primarily in plate form but there are also some talc fibers and ribbons. Tremolite was detected on all three 

aliquots. At least 100 tremolite particles were documented for each aliquot. The length and width of each particle was 

recorded and the mass was calculated using both the ASTM D5756 and ISO 22262-2 methods. The percentage of 

tremolite was calculated using the mass from both calculations and the range was reported. 

305281-4 9.86% to 15.5% 

305281-4a 1.35% to 1.82% 

305281-4b 2.75% to 4.32% 

The range of tremolite in aliquot 4 is substantially higher than 4a and 4b. One large particle, #24, accounts for 85% of the 

total mass of tremolite counted in aliquot 4. When the mass of that particle is removed from the total the range of 

tremolite is 1.54% - 2.41%. The dramatic effect of this one particle on the total percent is a result of the dilution factors 

from preparation. The tremolite particles varied in morphology from small blocks to very long, high length to width 

aspect ratio fibers. The length to width aspect ratio of particles counted ranged from 1.27 to 113.9. The mean aspect 

ratio is 11.5. The chemistry of the tremolite observed consisted of O, Mg, Si, and Ca. A few particles had small amounts 

of Al and Fe. One chrysotile fiber was counted on sample 305281-4a. 

The following chart is a plot aspect ratio vs length for all the particles counted over all three aliquots. 

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Re: FDA Office of Cosmetics & Colors

 COC 305281, Revision 2

Tremolite 

Aspect Ratio vs Length 

120.00 

100.00 

80.00 Aspect Ratio 60.00 

40.00 

20.00 

0.00 

120.00 

0 5 10 15 

Length microns 

Tremolite 

Aspect Ratio vs Width 

20 25 

100.00 

80.00 Aspect Ratio 60.00 

40.00 

20.00 

0.00 

0 1 2 3 4 5 6 7 8 

Width microns 

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COC 305281, Revision 2 

0 

1 

2 

3 

4 

5 

6 

7 

8 

0 5 10 15 20 25 

Width microns 

Length microns 

Tremolite 

Width vs Length 

Below are pictures, diffraction patterns, and chemistry from some of the counted particles. The unidentified peaks in 

chemistry spectra are copper, zinc, and carbon. Those peaks are from the TEM specimen holder and specimen grid. 

305281-4 Particle 2 8.9 x 0.35 microns Tremolite 

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COC 305281, Revision 2 

Element 

Line 

Weight % Weight % 

Error 

O K 51.41 ± 2.37 

Mg K 18.09 ± 0.54 

Al K 1.98 ± 0.29 

Si K 25.57 ± 0.35 

Si L --- ---

Ca K 2.96 ± 0.19 

Ca L --- ---

Total 100.00 

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COC 305281, Revision 2 

305281-4 Particle 3 1.6 x 0.2 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 53.11 ± 1.38 

Mg K 16.92 ± 0.30 

Si K 27.08 ± 0.30 

Si L --- ---

Ca K 2.89 ± 0.09 

Ca L --- ---

Total 100.00 

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COC 305281, Revision 2 

305281-4 Particle 4 3.0 x 1.2 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 48.04 ± 1.69 

Mg K 17.67 ± 0.35 

Si K 30.30 ± 0.38 

Si L --- ---

Ca K 3.99 ± 0.13 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-4 Particle 5 2.7 x 1.3 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 50.90 ± 1.56 

Mg K 16.75 ± 0.34 

Si K 28.70 ± 0.35 

Si L --- ---

Ca K 3.65 ± 0.12 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-4 Particle 6 1.2 x 0.8 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 49.72 ± 1.38 

Mg K 17.25 ± 0.29 

Si K 29.30 ± 0.30 

Si L --- ---

Ca K 3.74 ± 0.10 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-4 Particle 7 2.3 x .8 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 49.62 ± 1.60 

Mg K 17.26 ± 0.35 

Si K 29.41 ± 0.37 

Si L --- ---

Ca K 3.71 ± 0.12 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-4 Particle 8 5.6 x 0.18 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 55.70 ± 2.05 

Mg K 16.34 ± 0.44 

Si K 25.17 ± 0.42 

Si L --- ---

Ca K 2.79 ± 0.13 

Ca L --- ---

Total 100.00 

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COC 305281, Revision 2 

305281-4 Particle 9 5.8 x 1.3 microns Tremolite (#9 is the large particle. Particle 10 is also pictured to the left of 9) 

Element 

Line 

Weight % Weight % 

Error 

O K 50.52 ± 1.60 

Mg K 18.00 ± 0.35 

Si K 27.86 ± 0.35 

Si L --- ---

Ca K 3.63 ± 0.12 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-4 Particle 11 20.5 x 0.18 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 54.02 ± 3.07 

Mg K 14.93 ± 0.54 

Si K 27.96 ± 0.56 

Si L --- ---

Ca K 3.09 ± 0.18 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-4 Particle 12 4.5 x 1.7 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 48.73 ± 1.26 

Mg K 17.21 ± 0.28 

Si K 29.82 ± 0.30 

Si L --- ---

Ca K 4.24 ± 0.10 

Ca L --- ---

Total 100.00 

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COC 305281, Revision 2 

305281-4 Particle 13 & 14 4.4 x 1.3 microns & 15.6 x 0.8 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 52.28 ± 1.64 

Mg K 17.40 ± 0.35 

Si K 27.41 ± 0.36 

Si L --- ---

Ca K 2.92 ± 0.11 

Ca L --- ---

Total 100.00 

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COC 305281, Revision 2 

305281-4 Particle 15 2.7 x 0.26 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 59.21 ± 2.63 

Mg K 17.88 ± 0.68 

Si K 19.08 ± 0.52 

Si L --- ---

Ca K 3.84 ± 0.14 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-4 Particle 51 4.8 x 0.2 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 52.86 ± 2.32 

Mg K 17.64 ± 0.46 

Si K 26.86 ± 0.48 

Si L --- ---

Ca K 2.64 ± 0.13 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-5, 5A, 5B, Client Sample D31 

PLM 

All three aliquots of sample D31 were analyzed by on January 31, 2019. Tremolite was observed 

on all three aliquots but no points were counted. No other asbestos was detected. The results were calculated using the 

(b) (6)

equations detailed in the calculations section. 

305281-5 <0.18% Tremolite detected 

305281-5A <0.18% Tremolite detected 

305281-5B <0.18% Tremolite detected 

305281-5 Tremolite 100x 

305281-5A Tremolite 100x 

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COC 305281, Revision 2 

305281-5B Tremolite 100x 

TEM 

Samples 5, 5A and 5B were analyzed by on January 15-17, 2019. Talc is the main constituent in all 

three aliquots. The talc is primarily in plate form but there are also some talc fibers and ribbons. Tremolite and chrysotile 

(b) (6)

was detected on all three aliquots. 20 grid openings were analyzed on all three aliquots. Sample 5 had 43 tremolite and 

7 chrysotile particles counted. Sample 5A had 43 tremolite and 5 chrysotile particles. Sample 5B had 55 Tremolite and 9 

chrysotile particles. The length and width of each particle was recorded. The mass of the tremolite was calculated using 

both the ASTM D5756 and ISO 22262-2 methods. The mass of the chrysotile was calculated using the ASTM D5756 

method. 

305281-5 0.156% to 0.244% 

305281-5A 0.171% to 0.268% 

305281-5B 0.134% to 0.210% 

The tremolite particles varied in morphology from small blocks to very long, high length to width aspect ratio fibers. The 

length to width aspect ratio of particles counted ranged from 1.40 to 58.33. The mean aspect ratio is 11.0. The chemistry 

of the tremolite observed consisted of O, Mg, Si, and Ca. The chrysotile particles were high length to width aspect ratio 

fibers. The aspect ratio ranged from 6.5 to 280. The mean aspect ratio was 41.8. The chemistry of the chrysotile was O, 

Mg, Si, Fe. 

The following charts are a plot of the aspect ratio vs length for all the particles counted over all three aliquots, for the 

tremolite only, and for the chrysotile only. 

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COC 305281, Revision 2 

0.00 

50.00 

100.00 

150.00 

200.00 

250.00 

300.00 

0 2 4 6 8 10 12 14 16 18 

Aspect Ratio 

Length microns 

Tremolite and Chrysotile 

Tremolite 

Chrysotile 

Aspect Ratio vs 

0.00 

10.00 

20.00 

30.00 

40.00 

50.00 

60.00 

70.00 

0 2 4 6 8 10 12 14 16 18 

Aspect Ratio 

Length microns 

Tremolite 

Tremolite 

Aspect Ratio vs 

Length 

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COC 305281, Revision 2 

0.00 

50.00 

100.00 

150.00 

200.00 

250.00 

300.00 

0 2 4 6 8 10 12 14 16 

Aspect Ratio 

Length microns 

Chrysotile 

Chrysotile 

Aspect Ratio vs Length 

0.00 

10.00 

20.00 

30.00 

40.00 

50.00 

60.00 

70.00 

0 0.5 1 1.5 2 2.5 3 

Aspect Ratio 

Width microns 

Tremolite 

Tremolite 

Aspect Ratio vs Width 

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COC 305281, Revision 2 

0 

0.5 

1 

1.5 

2 

2.5 

3 

0 2 4 6 8 10 12 14 16 18 

Width microns 

Length microns 

Tremolite 

Tremolite 

Width vs Length 

Below are pictures, diffraction patterns, and chemistry from some of the counted particles. The unidentified peaks in 

chemistry spectra are copper, zinc, and carbon. Those peaks are from the TEM specimen holder and specimen grid. 

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COC 305281, Revision 2 

305281-5 Particle 3 8.0 x 0.40 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 59.45 ± 1.68 

Mg K 16.67 ± 0.51 

Si K 22.15 ± 0.47 

Si L --- ---

Ca K 1.73 ± 0.09 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-5 Particle 4 12.0 x 0.60 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 59.77 ± 1.60 

Mg K 17.11 ± 0.51 

Si K 21.58 ± 0.45 

Si L --- ---

Ca K 1.54 ± 0.09 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-5 Particle 5 12.0 x 0.60 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 59.22 ± 1.53 

Mg K 17.13 ± 0.47 

Si K 22.06 ± 0.43 

Si L --- ---

Ca K 1.60 ± 0.09 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-5 Particle 6 1.70 x 0.25 microns Tremolite 

Element 

Line 

Weight % Weight % 

Error 

O K 58.34 ± 2.26 

Mg K 17.65 ± 0.67 

Si K 22.56 ± 0.63 

Si L --- ---

Ca K 1.45 ± 0.12 

Ca L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-5B Particle 49 1.40 x 0.15 microns Chrysotile 

Element 

Line 

Weight % Weight % 

Error 

O K 55.89 ± 1.44 

Mg K 24.04 ± 0.49 

Si K 20.07 ± 0.42 

Si L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

305281-5B Particle 56 2.50 x 0.06 microns Chrysotile 

Element 

Line 

Weight % Weight % 

Error 

O K 60.28 ± 3.44 

Mg K 22.85 ± 1.17 

Si K 16.86 ± 0.96 

Si L --- ---

Total 100.00 

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

etected the 

(b) (6) (b) (6)

(b) (6)

(b) (6)

(b) (6)

QC Discussion: 

During preparation, one blank control sample and one reference control sample were prepared. These samples were 

prepared alongside the customer samples. The blank sample was prepared using Sigma-Aldrich Talc Powder, <10 

micron and was analyzed by on January 31, 2019. No asbestos was detected on the blank sample. 

The reference sample was made from the same Sigma-Aldrich talc powder spiked with 0.4% Chrysotile. The reference 

sample was analyzed by on February 21, 2019 and found to be within acceptable limits. 

Our laboratory information management systems (LIMS) randomly selected sample 305281-6/D96 for additional 

replicate QC analysis.

(b) (6)

 Separate preparations were made for PLM and TEM analysis.

(b) (6)

 The replicate QC analysis was 

performed by on January 31, 2019 for PLM analysis and by on February 18, 2019 for 

TEM analysis. The QC results matched the original analysis. 

Attachments: 

The following items are attached to this case narrative for your reference: 

1) Sample Log-In Sheet 

2) Daily PLM Scope Calibration Log 

3) Refractive Index Oil Calibration Log 

4) Daily TEM Scope Calibration Log 

5) QC Results Summary 

6) Replicate & Duplicate QC Chart for for samples analyzed between 9/1/2018 and 

2/18/2019 

7) Replicate & Duplicate QC Chart for for samples analyzed between 1/1/2018 and 2/18/2019 

8) Replicate & Duplicate QC Chart for for samples analyzed between 1/1/2018 and 2/18/2019 

9) Replicate & Duplicate QC Chart for for samples analyzed between 1/1/2018 and 2/18/2019 

10) Raw Data Sheets 

a. Gravimetric Data 

b. Filtration Worksheets 

c. PLM Analysis 

d. TEM Analysis 

e. QC Samples 

(b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6)

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Re: FDA Office of Cosmetics & Colors 

COC 305281, Revision 2 

I certify that all information contained in this report pertaining to laboratory events, procedures, and protocols is true 

and accurately describes the handling of this project by AMA Analytical Services, Inc. and its personnel. 

2/21/2019 

Date 

Laboratory Director 

Andreas Saldivar 

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