Can Coatings Primer and Safety Assessment: Communicating Evidence of Absence

Transcription

1 Can Coatings Primer and Safety Assessment: Communicating Evidence of Absence

2 Conflict of Interest Statement Mark Maier is currently a paid consultant and former employee of the Valspar Corporation. This educational presentation is made solely by and on behalf of Sheperian Toxicology, LLC who is responsible for its content. Mark Maier received no compensation from Valspar Corporation for this work. Fair Use Notice Graphics in this presentation are/were publicly available and are used solely for educational purposes and may not be used otherwise. Source credit is given for graphics in this presentation when available.

3 Different Cans, Different Coatings

4 Food & Beverage Ends Coil Coating National Coil Coating Assn Valspar Corp.

5 Food Can Manufacturing Two Piece Three Piece Side Seam

6 Beverage Can Multi-Step Engineering Marvel Engineer Guy Bill Hammack, Univ. Illinois The Ingenious Design of the Aluminum Beverage Can YouTube:

7 Demands Placed on Coatings Engineer Guy Bill Hammack, Univ. Illinois The Ingenious Design of the Aluminum Beverage Can

8 Beverage Can Manufacturing Crown Beverage Packaging, Inc. Visy Industries Holdings Pty Ltd

9 Beverage Can Ends Han, J. et al. Appl. Erg : 150 End Punched from Coated Coil Pressco Technology Inc. Tooling and Riveting Pressco Technology, Inc. Coating must maintain seal after tooling and riveting

10 Migration from Film INCDTIM Romania

11 Migration Chromatogram Innovations in Food Safety, Shelf Life and Food Safety

12 If BPA is Replaced, What Choices are Available? BPA BASED EPOXY Beverage End Beverage Body 3PC Food Food D&I Food DRD Food End Food EZO Closure Acrylic Vinyl Oleo PE 1 PE II

13 Wish List for BPA Replacement Coating 1. Epoxy Performance must be epoxy chemistry 2. No estrogenic monomers 3. Total Migration < 50 ppm (0.5 mg/in 2 ); < 1,000 Da. 4. Specific Migrations < 0.5 ppb (TTC-based) 5. Industrial Scale Raw Materials 6. Acceptable cost

14 Step 1 Find New Materials Valspar Corp Valspar Corp

15 Most New Coatings were Made Using Pre- Authorized Materials Listed in the Box

16 Epoxy Monomers in the Box were Estrogenic New Molecules Were Needed

17 Performance vs. Hazard Chemical Reactivity No Biological Hazard

18 Molecules were Needed that React with Each Other but physiologically, do

19 And

20 What Can be Learned from BPA Epoxy? 1 A. Bisphenol A is estrogenic in vitro B. There are two sources of BPA in the polymer synthesis 2 C. 4,4'- methylenediphenol functionality found in BPA is essential

21 A. Is There a Non-Estrogenic Bisphenol? Bisphenols are the only commercially viable source for 4,4'-methylenediphenol functionality.

22 B. Could the Bisphenol be Taken Out of the Last Step? BP A

23 C. V70 Route of Synthesis 4,4'-methylenediphenol functionality

24 Why Should People Believe these Molecules are Safe? Just because I said so?

25 Prescriptive Approaches were Tried contradict misunderstand Green Screen Force Fit default TIPED Excessive

26 Keeping in Mind Reactants Products

27 GreenScreen Sodium Chlorine

28 Tiered Protocol for Endocrine Disruption (TiPED) Designing endocrine disruption out of the next generation of chemicals. Schug et al. Green Chem., 2013,15, ? While in silico and in vitro assays offer less costly starting points, in vivo assays are necessary to conclude that a chemical is unlikely to have EDC activity.

29 contradict misunderstand Green Screen Force Fit default TIPED Excessive

30

31 Do Your Own Science First Table III. Summary of analysis and assay results for ER (read-across target) and read-across sources TMBPFDGE, BADGE, NOGE and oligo-bfdge. Green = Negative experimental result, Red = Positive experimental result RA = Read-across (only applies to target substance, ER) ND = no data available Numbers indicate relative potency in the standard Ames assay (Table IV) In vitro ER TMBPFDGE BADGE NOGE oligo- BFDGE MLA -S9 culture ND MLA +S9 culture ND TA-98 -S9 plate TA-100 -S9 plate TA S9 plate TA S9 plate TA-98 +S9 plate TA-100 +S9 plate TA S9 plate TA S9 plate Mutagenicity CAESAR Model Model Model Model Model Model TA-98 -S9 mpf RA ND ND ND TA-100 -S9 mpf RA ND ND ND TA S9 mpf RA ND ND ND TA S9 mpf RA ND ND ND TA-98 +S9 mpf RA ND ND ND TA-100 +S9 mpf RA ND ND ND TA S9 mpf RA ND ND ND TA S9 mpf RA ND ND ND GS GADD45 -S9 culture RA ND ND ND GS GADD45 +S9 culture RA ND ND ND In vivo Micronucleus Oral Oral Oral ND Oral Comet Assay or other DNA damage Oral Oral Oral Oral Oral Chromosomal aberration RA ND Oral Oral Oral Transgenic Mouse RA ND ND Oral Carcinogenicity RA ND ND Dermal Carcinogenicity Model Model Model Model Model Carcinogenicity QSAR QSAR QSAR QSAR QSAR Repeated Oral Dose (mg/kg-bw/d) 28-56Day NOAEL = 100 LOAEL = 300 Repro/Dev NOAEL = 300 ND Chronic NOAEL = 15 Subchronic NOAEL = 50; LOAEL = 250 ND 90-Day NOAEL = 250 (limit dose) 14-day NOAEL = 300; LOAEL = 1000

32 Ask for Help Regulatory Dutch G4 32 (Listing does not necessarily imply endorsement, approval, or further discussion)

33 Then Let Your Best Critics Review Your Work, do Their Own, and Try to Prove You are Wrong.

34 Go Beyond Female mammary glands (right side) were whole-mounted for threedimensional inspection Terminal end buds, branching, budding and ductal extension were examined; lymph node was used as point of reference Qualitative analysis Absence Minimal Slight Moderate Marked Abundant

35 Go Beyond Extract Concentration

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37 References Engineer Guy Bill Hammack, Univ. Illinois. The Ingenious Design of the Aluminum Beverage Can. Soto AM, Schaeberle C, Maier MS, Sonnenschein C, Maffini MV. Evidence of Absence: Estrogenicity Assessment of a New Food-Contact Coating and the Bisphenol Used in Its Synthesis. Environ Sci Technol Feb 7; 51(3):

38 Acknowledgements Tom Mallen, Ronnie Weaver, and everyone at Valspar Maricel Maffini Independent Consultant Ana Soto Lab Tufts University Food and Beverage Brand Owners Can Makers and

39 Talented Scientists & Engineers from these Organizations (Listing does not necessarily imply endorsement or approval) Dutch G4 3 9