Phthalates: Workshop on Potential Ways To Reduce Third Party Testing Costs Through Determinations Consistent With Assuring Compliance

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Phthalate determinations as a means for third party testing cost reduction: questions, issues, and comments. CPSC staff presentation followed by panelist presentations.

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Phthalates: Workshop on Potential Ways To Reduce Third Party Testing Costs Through Determinations Consistent With Assuring Compliance

  1. 1. U.S. Consumer Product Safety Commission Workshop on Potential Ways To Reduce Third Party Testing Costs Through Determinations Consistent With Assuring Compliance April 3, 2014 This presentation was prepared by CPSC staff, has not been reviewed or approved by, and may not reflect the views of, the Commission.
  2. 2. US CONSUMER PRODUCT SAFETY COMMISSION Disclaimer  This presentation was prepared by CPSC staff, has not been reviewed or approved by, and may not reflect the views of, the Commission.  The views and opinions expressed by public participants during this workshop are those of the participants and do not represent official government policies or positions of the Commission or its staff.  This workshop is being webcast and recorded. Please identify yourself when speaking. 4/3/2014 2
  3. 3. PHTHALATES Moderator: Jacqueline Campbell 4/3/2014 US CONSUMER PRODUCT SAFETY COMMISSION 3
  4. 4. Phthalates  A possible determination could identify materials that do not, and will not, contain prohibited phthalates in concentrations above 0.1 percent 4/3/2014 4US CONSUMER PRODUCT SAFETY COMMISSION
  5. 5. Phthalates  What specific data should staff consider when deciding whether to recommend that the Commission make a determination?  How can staff be assured that a material, regardless of its origin, manufacturing process, potential for contamination or any other factor, would continue to comply with the phthalates limit indefinitely into the future as the material continues to be produced? 4/3/2014 US CONSUMER PRODUCT SAFETY COMMISSION 5
  6. 6. Phthalates  What kind of follow-up activities should be required to assure continued compliance of a material?  What other technical, practical, or implementation issues should CPSC staff consider before possibly making recommendations to the Commission regarding phthalates determinations?  What materials would provide the greatest cost savings if the Commission made a determination that the material did not contain the prohibited phthalates above 0.1 percent? Why? 4/3/2014 US CONSUMER PRODUCT SAFETY COMMISSION 6
  7. 7. 2009 Statement of Policy:* Materials that may contain phthalates  Polyvinyl chloride (PVC) and related polymers, such as polyvinylidene chloride (PVDC), and polyvinyl acetate (PVA);  Soft or flexible plastics, except polyolefins;  Soft or flexible rubber, except silicone rubber and natural latex;  Foam rubber or foam plastic, such as polyurethane (PU);  Surface coatings, non-slip coatings, finishes, decals, and printed designs;  Elastic materials on apparel, such as sleepwear;  Adhesives and sealants;  Electrical insulation; and  Other materials: other plastics, inks, air fresheners, and scented products. 4/3/2014 US CONSUMER PRODUCT SAFETY COMMISSION 7 *http://www.cpsc.gov//PageFiles/126588/componenttestingpolicy.pdf
  8. 8. Materials that may contain phthalates  What materials should always require third party testing because of potential phthalate content above 0.1 percent? Why?  What specific data or other information should be sufficient to characterize a material as potentially containing one or more of the prohibited phthalates, and thus, always require third party testing for compliance to the phthalates limit? 4/3/2014 US CONSUMER PRODUCT SAFETY COMMISSION 8
  9. 9. CPSC Phthalates Symposium, March 1, 2012 Failure Rate by Self-Declared Material (Intertek) 4/3/2014 US CONSUMER PRODUCT SAFETY COMMISSION 9 *Bob Altkorn, Intertek, presentation, ―Phthalates Screening and Testing Methods,‖ 3/1/2012, http://www.cpsc.gov/Media/Documents/Regulations-Laws--Standards/CPSIA/Same-Symposium-Different-Links-Temp/altkorn03012012/
  10. 10. Conforming Plastics  What raw materials are used, could be used, or may be used to create plastics that meet these requirements, as well as information about the possibility of those materials containing or being exposed to any prohibited phthalate?  Information about the potential use of recycled content in these plastics, and the possibility that phthalates may be included at noncompliant levels? 4/3/2014 US CONSUMER PRODUCT SAFETY COMMISSION 10
  11. 11. Conforming Plastics  Information about the possibility or likelihood of contamination of the component part or finished product with a prohibited phthalate?  How or why continued manufacture, regardless of origin, would continue to be compliant with the phthalates limit? 4/3/2014 US CONSUMER PRODUCT SAFETY COMMISSION 11
  12. 12. Conforming Plastics  How the Commission might effectively address new applications or methods of production of plastics that may include the addition of phthalates or otherwise result in unacceptable levels of phthalates?  What other technical, practical, or implementation issues should CPSC staff consider before possibly making recommendations to the Commission regarding a phthalates determination for a plastic? 4/3/2014 US CONSUMER PRODUCT SAFETY COMMISSION 12
  13. 13. Conforming Plastics  What would be the potential cost savings if such a determination were recommended and adopted, especially considering that compliance with the underlying standard(s) would still be required? 4/3/2014 US CONSUMER PRODUCT SAFETY COMMISSION 13
  14. 14. Panel Participants  Dave Owens, BASF  Sanjeev Gandhi, SGS Consumer Testing Services  Alan Kaufman, Toy Industry Association  Sheila Millar, Keller and Heckman, LLP  Kyra Mumbauer, Society of the Plastics Industry 4/3/2014 US CONSUMER PRODUCT SAFETY COMMISSION 14
  15. 15. David Owen BASF Corporation April 3, 2014 CPSC Workshop Phthalate Applications
  16. 16. CPSIA Law  CONSUMER PRODUCT SAFETY IMPROVEMENT ACT OF 2008  PUBLIC LAW 110–314—AUG. 14, 2008  Sec. 101 Lead  Sec. 102 Mandatory third party testing  Sec. 108 Prohibition on sale of certain products containing specified phthalates 16
  17. 17. CPSIA Law  Children’s toy that can be placed in a child’s mouth  Child care article  sucked and chewed  smaller than 5 centimeters in one dimension 17
  18. 18. CPSIA Law  Sec. 108 Phthalates  DBP  BBP  DOP (DEHP)  DnOP  DINP  DIDP 18
  19. 19. CPSIA Law  concentrations of more than 0.1 percent  Each phthalate can be present at 0.1%  PERMANENT PROHIBITION  DBP  BBP  DOP  INTERIM PROHIBITION  DnOP  DINP  DIDP 19
  20. 20. Phthalates  FDA approved for food contact  Closures  Wraps  Used in medical applications  Blood bags  Tubing 20
  21. 21. Phthalate Chemistry 21 Phthalic Anhydride Plus 2 alcohols
  22. 22. Phthalate Chemistry 22
  23. 23. Chromatograms Overlay 23
  24. 24. Physical Properties  Density – ~1  Viscosity – Less than 100 centipoise  Pour Point – ~ -40  Flash Point – > 200 C  Vapor Pressure – ~ 6 millibar @ 200 C 24
  25. 25. Uses  Plasticizer  Diluent  Lubricant 25
  26. 26. Plasticizer for  PVC  Rubber  Acrylics  Nitrocellulose  Urethane  Polyvinyl Acetate  Polyvinyl butyral 26
  27. 27. Typically Not For  Olefins – Compatibility  Stryrenics – Stress Cracking  Nylon – Can use water  Rigid PVC – Antiplasticization 27
  28. 28. Theory  Cohesive Energy Density/Solubility Parameter  Gibbs Free Energy  The Technology of Plasticizers Sears & Darby  Handbook of Plasticizers Wypych 28
  29. 29. Thanks  BASF Corporation  Uwe Storzum  Kathy Stahl  Kristi Utecht  ANA  ASTM Task Group Members THIS PRESENTATION IS INTENDED AS GENERAL INFORMATION OF CURRENT INTEREST AND IS NOT INTENDED AS LEGAL ADVICE. BASF CORPORATION (BASF) MAKES NO WARRANTY OR REPRESENTATION, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE ACCURACY OR COMPLETENESS OF THE INFORMATION CONTAINED HEREIN, AND ASSUMES NO LIABILITY OF ANY KIND WHATSOEVER RESULTING FROM THE USE OF OR RELIANCE UPON ANY INFORMATION, PROCEDURES, CONCLUSION, OPINION OR RESULTS OBTAINED. 29
  30. 30. CPSC Workshop Potential Ways to Reduce Third Party Testing CPSC National Product Testing and Evaluation Center Rockville, Maryland April 03, 2014 Sanjeev Gandhi DVP and Technical Director SGS North America, Inc.
  31. 31. 31 Workshop Goals  Identify what material specific exemptions can be determined to reduce testing based validation Phthalates, Lead, and 8 Soluble HMs  Consider Intrinsic material characteristics Manufacturing, processing, downstream use  Compliance should not be compromised  Provide tangible saving in testing cost
  32. 32. 32 Phthalates  Phthalates: Suspect list exists  vinyl and vinyl like soft plastics Create a Positive List for exempt plastics/materials Plastics commonly used in consumer applications*  PE  33 %  PP  21 %  PS  8 %  PVC17 %  ABS< 10% * Plastics Europe: MRG Report Other Plastics: Not common for consumer products POM  automotive and consumer electronics PBT  electrical housings, automotive plugs, showerheads PC  electronics, construction, aerospace PLA  medical implants, biodegradable PPS  electrical insulation, specialty membranes
  33. 33. 33 A look at the empirical data....  Test data for phthalates 10, 400 data points Plastics data represents 60 -70 of the total data points The bill of materials is not provided
  34. 34. 34 Testing Lab perspective ....  Lab data for phthalates Data is not granular to provide specific polymers that can be considered categorically for exemption Across all the plastic and rubber like materials, high compliance rate with the limits, approx 95% The difference in fail and positive detection (above DL) ≈ 1000 data points (for plastics and rubber) This alludes to possible contamination issue Mixing of polymers intended or otherwise
  35. 35. 35 Phthalates  Technical/Practical considerations determination of a positive list Bill of materials from upstream supplier: guarantee letter Exemption based on material properties that change pure polymers with addition of plasticizer – Shore hardness  known potential issues – Glass transition temperature  not fully examined in scientific literature
  36. 36. Opportunities to Reduce Third Party Testing Costs for the Plastics Industry Consumer Product Safety Commission April 3, 2014
  37. 37. Founded in 1937, SPI is the only U.S. trade association representing all segments of the plastics industry.
  38. 38. MISCONCEPTION: All plastic materials used in children’s products must be tested to ensure compliance with phthalate limits. REALITY: • The restricted ortho-phthalate plasticizers may be intentionally added to flexible polyvinyl chloride, polyvinylidene chloride, chlorinated polyvinyl chloride and thermoset polyurethanes to make these materials flexible. • The restricted ortho-phthalate plasticizers will NOT be added to rigid plastic materials (Shore “A” Hardness ≥ 90), nor will they be present in these materials as contaminants at levels higher than 1000ppm. • The restricted ortho-phthalates are incompatible with many plastic materials (e.g., styrenics, polyolefins), and these materials are made flexible by other means. May contain phthalates > 1000ppm Will not contain phthalates > 1000ppm
  39. 39. Plastic Materials that May be Excluded from Testing • Rigid plastics with Shore “A” Hardness ≥90 • Acetal/polyoxymethylene (POM) homopolymer • 1,3,5-trioxane, copolymer with 1,3-dioxolane (acetal/polyoxymethylene (POM) copolymer) • Acrylic (polymethylmethacrylate and polyacrylonitrile) • Acrylonitrile butadiene styrene terpolymers (ABS) • Butadiene-ethylene resins • Butene-ethylene copolymers • Ethylene copolymers • Ethylene acrylic acid copolymers • Ethylene-propylene copolymers • Ethylene vinyl acetate copolymers • Ethylene vinyl acetate vinyl alcohol copolymers • Ethylene vinyl alcohol copolymers • Ionomers • Liquid crystal polymers (hydroxybenzoic acid copolymers) • Nylon/polyamide • Olefin thermoplastic elastomers (such as EPDM) • Polybutene
  40. 40. Plastic Materials that May be Excluded from Testing • Polybutylene terephthalate • Polycarbonate • Polyesters • Polyethylene (LLDPE, LDPE, MDPE, HDPE and UHMWPE) • Polyethylene terephthalate • Polylactic acid • Polyphenylene sulfide • Polypropylene • Polystyrene • Polytetramethylene glycol-dimethyl terephthalate-1,4- butanediol copolymer (polyester elastomer) • Propylene-ethylene copolymers • Silicone rubber (pure) • Styrene-butadiene copolymers • Styrene-butadiene-styrene rubbers (SBS/SBR) • Styrene-acrylonitrile copolymers (SAN) • Vinylidene chloride/methyl acrylate copolymers • CMYK Process Inks
  41. 41. MISCONCEPTION: Cross-contamination may lead to the unintentional presence of phthalates in excess of 1000ppm in a variety of plastic products. REALITY: Manufacturers have strong incentives to avoid cross-contamination of rigid plastics with phthalates or with flexible PVC that may contain phthalates. Destruction of resin Off-gassing from chemical reaction Corrosion of equipment Facility evacuation Poor technical performance
  42. 42. SPI’s Recommendation to Reduce Testing Costs SPI respectfully requests that the Commission: • Specify that rigid plastic materials with Shore “A” Hardness of 90 or greater will not contain the restricted phthalates in excess of specified limits. • Publicly identify the many types of plastic materials that are known not to contain the restricted phthalates in excess of specified limits.
  43. 43. Thank you! Kyra Mumbauer Senior Director, Global Regulatory Affairs SPI: The Plastics Industry Trade Association O: 202-974-5214 C: 202-427-4472 kmumbauer@plasticsindustry.org
  44. 44. U.S. Consumer Product Safety Commission Workshop on Potential Ways to Reduce Third-Party Testing Costs Through Determinations Consistent With Assuring Compliance Sheila A. Millar, Partner KELLER AND HECKMAN LLP 1001 G Street, N.W. Suite 500 West Washington, D.C. 20001 +1 202.434.4143 millar@khlaw.com April 3, 2014
  45. 45. Who Is FJATA? We make and sell jewelry. • About 225 companies • Mostly small businesses • Led drafting of Children’s Jewelry Standard (ASTM F2923-11) and Adult Jewelry Standard (ASTM F2999-13) • Leading process to update both standards
  46. 46. Phthalates Testing Requirements & the Marketplace • Jewelry items are not toys • The distribution chain has begun imposing testing requirements that match CPSC’s, even for products that do not require such testing • Testing is a significant added burden for jewelry items • Component testing multiplies test costs
  47. 47. Rigid Plastics Will Not Contain Phthalates • When phthalates are present, they are added intentionally in amounts far about the trace levels that CPSIA bans • The limited available data from FJATA member tests shows phthalates either not present or present in levels under 25% of the maximum in tested rigid plastics
  48. 48. CPSC Rule Needed to Eliminate Unnecessary Test Costs • Rigid plastics – materials with a Shore ―A‖ Hardness rating 90 or above - will not contain phthalates. • In fact, most plastics will not contain phthalates • Technical data supports, with a high degree of assurance, that these materials will not contain phthalates and CPSC should issue a rule recognizing exclusions from phthalates testing
  49. 49. Thank you! Sheila A. Millar, Partner KELLER AND HECKMAN LLP 1001 G Street, N.W. Suite 500 West Washington, D.C. 20001 +1 202.434.4143 millar@khlaw.com April 3, 2014

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