Opportunities and Requirements in CFR 16 – Safety Testing of USA Consumer Goods and Laboratory Accreditation Bill Hirt, Ph.D. ACLASS Sr. Accreditation Manager Guatemala SERVICE SUMMIT – September, 2009

ANSI-ASQ National Accreditation Board Laboratories – ISO/IEC 17025 Inspection Bodies – ISO/IEC 17020 RMPs – ISO Guide 34 (Reference Materials) PT Providers – ISO Guide 43/ILAC G13 Product Certifiers – ISO Guide 65 Government Programs: DoD ELAP, EPA Energy Star, CPSC Toy Safety, NRC, NIST IPV6, US Navy TRAINING Programs Certification Bodies - ISO/IEC 17021 Accreditation for Management System Certification Bodies that certify to : ISO 9001 (QMS), ISO 14001 (EMS), TS 16949 (US Automotive) etc.

International Recognition Asia Pacific Laboratory Accreditation Cooperation (APLAC) International Laboratory Accreditation Cooperation (ILAC) European Cooperation for Accreditation (EA) Inter-American Accreditation Cooperation (IAAC) ACLASS (USA) A2LA (USA) IAS (USA) L-A-B (USA) NVLAP (USA) Asia-Pac Countries European Bodies ACLASS (USA) A2LA (USA) South America Central America Mexico

Examples of U.S. Regulators Embracing Accredited 3rd Party Department of Defense Consumer Product Safety Commission Department of Energy Nuclear Regulatory Commission Environmental Protection Agency National Institute of Standards and Technology Department of Justice Federal Communications Commission Food and Drug Administration Department of Homeland Security Federal Aviation Administration

Lab Accreditation Confidence in Test Results Data is Traceable and Reproducible Reduce Uncertainties w/Decisions New Markets Competent Eliminate Redundancy Reduced Costs

Consumer Products Safety Improvement Act 2008 USA Legislation Consumer Products Safety Improvement Act

Key Provisions of CPSIA TITLE I – Children’s Product Safety Section 101. Children’s products containing lead; lead paint rule. Section 102. Mandatory third party testing for certain children’s products. Section 103. Tracking labels for children’s products. Section 104. Standards and consumer registration of durable nursery Section 105. Labeling requirement for advertising toys and games. Section 106. Mandatory toy safety standards. Section 107. Study of preventable injuries and deaths in minority children related to consumer products. Section 108. Prohibition on sale of certain products containing specified phthalates.

Main Chemical Targets LEAD PHTHALATES

LEAD Issues Lead poisoning known for > 100 yrs Laws to reduce Lead in gasoline and paint Lead paint limits  1 mg/cm2 or 0.5% by wt Paint sale ban if lead > 0.06 % WHO says lead in blood above 10 µg/dL is “of concern” 2007 study showed Lead test kits unreliable (from CPSC with false +’s and false –’s)

PHTHALATE Issues Introduced in 1920s as plasticizers Over 800 million pounds per yr used -- in over 50% of all plastics and many foods Over 25 variations have CAS numbers and 6 phthalates are clearly regulated Associated with cancers, birth defects and metabolic disruption May contribute to diabetes and obesity

Mandatory Third-Party Testing for Certain Children’s Products CPSC Public Meeting -- October 2, 2008 This presentation has not been reviewed or approved by the Commission and may not reflect its views.

Definition of Children’s Product The term “children’s product” is defined as a consumer product designed or intended primarily for children 12 years of age or younger.

What is a Children’s Product? In deciding what is a children’s product, CPSC must consider: A statement by the manufacturer about the intended use of such product if such statement is reasonable; Whether the product is represented in its packaging, display, promotion or advertising as appropriate for use by children 12 years of age or younger; Whether the product is commonly recognized by consumers as being intended for use by a child 12 years of age or younger; and The Age Determination Guidelines issued by the Commission staff in September 2002, and any successor to such guidelines.

Who Must Certify? “Every manufacturer of such children’s product (and the private labeler of such children’s product if such children’s product bears a private label)” Key definitions from the CPSA still apply :􀂄“Manufacturer means any person who manufacturers or imports a consumer product” “Private labeler means an owner of a brand or trademark on the label of a consumer product”

Is Third-Party Testing Required for All Children’s Products? The requirement for third-party testing applies to every children’s product that is subject to a “children’s product safety rule” The term “children’s product safety rule” is defined broadly to include any standard or ban under the CPSA or any “similar rule, regulation, standard or ban” under any other Act enforced by CPSC, including a rule declaring a consumer product to be a banned hazardous substance.

Methods for Third-Party Testing of Children’s Products Method for third-party testing depends on the standard, ban or similar rule applicable to the children’s product Ban on Lead-Containing Paint http://www.cpsc.gov/BUSINFO/leadsop.pdf http://www.cpsc.gov/BUSINFO/Recht.pdf Many of the Commission’s rules incorporate specific test methods: Cribs and pacifiers plus Bicycle helmets Where no test method currently exists, the CPSC staff will be providing additional guidance on test methods.

Third-Party Testing of Children’s Products

What Regulations Apply to Children’s Products ?

Rattle Third-Party Certification What tests need to be done by the accredited third-party lab? 16 C.F.R. 1510 Rattles (choking –specific test fixture identified) Lead-in Paint Small Parts Sharp Points or Edges and . . . Once Effective: ASTM F963 Lead Content Phthalates Clutching Toy or Rattle

Manufactured December 22, 2008  Certify to lead paint ban Rattle Third-Party Certification Timeline Manufactured December 22, 2008  Certify to lead paint ban Manufactured April 4, 2009  Certify to lead paint ban and small parts regulations Manufactured August 29, 2009  Certify to lead paint ban, small parts regulations and lead content limits Manufactured October 2, 2009  Certify to all applicable children’s product safety rules –includes all of the above plus phthalates, F963, the rattle test method . . .

“Rubber” Duck Third-Party Certification “Tested to all applicable standards”: Lead-in-paint  YES Small Parts  YES Lead Content in Substrate  YES Phthalates (once effective)  YES Electrical Hazard?  NO Strong Sensitizers?  Probably

Third-Party Certification Timeline Manufactured on December 22, 2008  Certify to 600 ppm lead paint ban Manufactured on August 29, 2009  Certify to 90 ppm lead paint ban and 300 ppm lead content limit Manufactured on October 2, 2009  Certify to lead paint ban, lead content limit, phthalates standard, ASTM F963-07 et al.

Phthalates Definitions and Testing ( Permanently Banned Phthalates ) Children’s Toy –consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays Child Care Article –consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething

Phthalates Definitions and Testing “ . . . any children’s toy that can be placed in a child’s mouth or child care article . . .” “For purposes of this section a toy can be placed in a child’s mouth if any part of the toy can be brought to the mouth and kept in the mouth by a child so that it can be sucked or chewed. If the children’s product can only be licked, it is not regarded as able to be placed in the mouth. If a toy or a part of a toy in one dimension is smaller than 5 centimeters, it can be placed in the mouth.” Interim Ban

Children’s Product vs. Children’s Toy for Phthalates Certification

Going Forward Know your product and its constituent components Pay careful attention to the third-party testing requirements as they phase in over the next year Watch our website for the posting of additional accredited labs and test methods Comment on our Federal register notices and web postings

LEAD Testing Methods from Literature Search Method Subcategory Method Source Source Method Identifier Analyte Name Media Name Instrumentation Inorganic AOAC 990.08 Lead and lead cmpds WATER ICP-AES EPA-OSW 6010 C VARIOUS EPA-NERL 200.1 ICP-MS USGS-NWQL I-7399 FLAA ASTM D5673 I-1401 GF-AAS I-1472-87 200.9 239.2 EPA-EAD 1638 Standard Methods 3500-Pb B Spectrophotometer Sampling/Preparation B-9001-95 (ICP-MS) ANIMAL TISSUE 1640 1637 D6502 XRF 3111B B-9001-95 (ICP-AES) also Soil / Air methods all charge $40 to $400 US per sample

Lead Test Method Sources AOAC EPA USGS ASTM Standard Methods CPSC

Lead Testing Technologies ICP – AES ICP – MS FLAA Spectrophotometric XRF (X-ray)

CPSC Phthalate Information Federal presentation (to follow here) Available on the CPSC website

Testing for Phthalates in Consumer Products

Evaluating Consumer Products for Phthalates Total Phthalate Content in Toy or Child Care Articles Prohibited Phthalates DEHP di (2-ethylhexyl) phthalate • DBP – dibutyl phthalate BBP – benzyl butyl phthalate Interim - Prohibited Phthalates DINP – di “isononyl” phthalate DIDP – di “isodecyl” phthalate DnOP – di-n-octyl phthalate

Evaluating Consumer Products for Phthalates CPSC Staff Method: http://www.cpsc.gov/about/cpsia/phthalatesop.pdf 1. Grind or mill toy into a powder 2. Dissolve/Extract in tetrahydrofuran (THF) 3. Precipitate with hexane 4. Analyze by GC/MS with Select Ion Monitoring (SIM) Seeking Comments: section108definitions@cpsc.gov

Alternate Methods - Phthalates

Sample Preparation for Phthalate Testing

Testing Issues for Phthalates See FAQ at http://www.cpsc.gov/about/cpsia/faq/faq.html#sect108 0.1 % of any of the 6 phthalates, not total of the 6. Must differentiate alternate plasticizers (not banned by CPSIA, but subject to FHSA) “CPSIA language differs from EU: any children’s toy or child care article that contains concentrations of more than 0.1 percent” of the regulated phthalates No inaccessibility exemption May consider alternate methods such as LC/MS if proposed and accompanied by evidence of effectiveness Composite testing

Identifying Phthalates Some of the regulated phthalates are complex mixtures and share similarities with non-regulated phthalates – care must be used to identify:

Screening For Phthalates FT/IR and Raman Spectroscopy – limited sensitivity, selectivity Pyrolysis GC/MS – possible breakdown of long chain phthalates such as DINP and DIDP, difficult quantification, not portable DART-MS – Direct Analysis Real Time Mass Spectrometry – difficult quantification, not portable ASTM D2124 extraction then FT/IR – time consuming, not portable

Bottom Line for CPSC Testing Laboratories Keep aware of timelines and US regulation updates Maintain or secure proficient technologies and laboratory management systems Secure ISO 17025 accreditation at least for key testing technologies

QUESTIONS ???