Phthalates: Workshop on Potential Ways To Reduce Third Party Testing Costs Through Determinations...

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.

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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

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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

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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

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Phthalates

FDA approved for food contactClosuresWraps

Used in medical applicationsBlood bagsTubing

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Phthalate Chemistry

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Phthalic Anhydride

Plus 2 alcohols

Phthalate Chemistry

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Chromatograms Overlay

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Physical Properties

Density – ~1

Viscosity– Less than 100 centipoise

Pour Point– ~ -40

Flash Point– > 200°C

Vapor Pressure– ~ 6 millibar @ 200° C

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Uses

Plasticizer Diluent Lubricant

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Plasticizer for

PVC Rubber Acrylics Nitrocellulose Urethane Polyvinyl Acetate Polyvinyl butyral

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Typically Not For

Olefins– Compatibility

Stryrenics– Stress Cracking

Nylon– Can use water

Rigid PVC– Antiplasticization

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Theory

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

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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.

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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.

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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

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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

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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

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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

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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

kmumbauer@plasticsindustry.org

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+1 202.434.4143millar@khlaw.com

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+1 202.434.4143millar@khlaw.com

April 3, 2014