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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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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.
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
PHTHALATESModerator: Jacqueline Campbell
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Phthalates
A possible determination could identify materials that do not, and will not, contain prohibited phthalates in concentrations above 0.1 percent
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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?
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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?
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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.
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*http://www.cpsc.gov//PageFiles/126588/componenttestingpolicy.pdf
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?
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CPSC Phthalates Symposium, March 1, 2012Failure Rate by Self-Declared Material (Intertek)
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*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/
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?
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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?
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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?
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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?
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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
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David OwenBASF Corporation April 3, 2014
CPSC WorkshopPhthalate Applications
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
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
CPSIA Law
Sec. 108 Phthalates
DBPBBPDOP (DEHP)DnOPDINPDIDP
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CPSIA Law
concentrations of more than 0.1 percent Each phthalate can be present at 0.1% PERMANENT PROHIBITION
DBPBBPDOP
INTERIM PROHIBITIONDnOPDINPDIDP
19
Phthalates
FDA approved for food contactClosuresWraps
Used in medical applicationsBlood bagsTubing
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Phthalate Chemistry
21
Phthalic Anhydride
Plus 2 alcohols
Phthalate Chemistry
22
Chromatograms Overlay
23
Physical Properties
Density – ~1
Viscosity– Less than 100 centipoise
Pour Point– ~ -40
Flash Point– > 200°C
Vapor Pressure– ~ 6 millibar @ 200° C
24
Uses
Plasticizer Diluent Lubricant
25
Plasticizer for
PVC Rubber Acrylics Nitrocellulose Urethane Polyvinyl Acetate Polyvinyl butyral
26
Typically Not For
Olefins– Compatibility
Stryrenics– Stress Cracking
Nylon– Can use water
Rigid PVC– Antiplasticization
27
Theory
Cohesive Energy Density/Solubility Parameter Gibbs Free Energy The Technology of Plasticizers Sears & Darby Handbook of Plasticizers Wypych
28
Thanks
BASF CorporationUwe StorzumKathy StahlKristi UtechtANA
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
CPSC Workshop Potential Ways to Reduce Third Party
Testing
CPSC National Product Testing and Evaluation Center Rockville, Maryland
April 03, 2014
Sanjeev GandhiDVP and Technical DirectorSGS North America, Inc.
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
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 % PVC17 % ABS< 10%
* Plastics Europe: MRG Report
Other Plastics: Not common for consumer productsPOM automotive and consumer electronicsPBT electrical housings, automotive plugs, showerheadsPC electronics, construction, aerospacePLA medical implants, biodegradable PPS electrical insulation, specialty membranes
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
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
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
Opportunities to Reduce Third Party Testing Costs for the Plastics Industry
Consumer Product Safety CommissionApril 3, 2014
Founded in 1937, SPI is the only U.S. trade association representing all segments of the plastics industry.
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
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
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
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
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.
Thank you!
Kyra MumbauerSenior Director, Global Regulatory
AffairsSPI: The Plastics Industry Trade
AssociationO: 202-974-5214C: 202-427-4472
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, PartnerKELLER AND HECKMAN LLP
1001 G Street, N.W.Suite 500 WestWashington, D.C. 20001+1 [email protected]
April 3, 2014
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
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
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
CPSC Rule Needed toEliminate 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
Thank you!
Sheila A. Millar, PartnerKELLER AND HECKMAN LLP
1001 G Street, N.W.Suite 500 WestWashington, D.C. 20001+1 [email protected]
April 3, 2014