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

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. 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. PHTHALATES
Moderator: Jacqueline Campbell
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4. 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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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?
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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?
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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.
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*http://www.cpsc.gov//PageFiles/126588/componenttestingpolicy.pdf

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?
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9. CPSC Phthalates Symposium, March 1, 2012
Failure 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/

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?
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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?
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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?
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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?
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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
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15. David Owen
BASF Corporation
April 3, 2014
CPSC Workshop
Phthalate Applications

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. 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. CPSIA Law
 Sec. 108 Phthalates
 DBP
 BBP
 DOP (DEHP)
 DnOP
 DINP
 DIDP
18

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. Phthalates
 FDA approved for food contact
 Closures
 Wraps
 Used in medical applications
 Blood bags
 Tubing
20

21. Phthalate Chemistry
21
Phthalic Anhydride
Plus 2 alcohols

22. Phthalate Chemistry
22

23. Chromatograms Overlay
23

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. Uses
 Plasticizer
 Diluent
 Lubricant
25

26. Plasticizer for
 PVC
 Rubber
 Acrylics
 Nitrocellulose
 Urethane
 Polyvinyl Acetate
 Polyvinyl butyral
26

27. Typically Not For
 Olefins
– Compatibility
 Stryrenics
– Stress Cracking
 Nylon
– Can use water
 Rigid PVC
– Antiplasticization
27

28. Theory
 Cohesive Energy Density/Solubility Parameter
 Gibbs Free Energy
 The Technology of Plasticizers Sears & Darby
 Handbook of Plasticizers Wypych
28

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. 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
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
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
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
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
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. Opportunities to Reduce
Third Party Testing Costs
for the Plastics Industry
Consumer Product Safety Commission
April 3, 2014

37. Founded in 1937, SPI is the only U.S. trade association
representing all segments of the plastics industry.

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. 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. 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. 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. 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. 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

62. 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

63. 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

64. 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

65. 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

66. 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

67. 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