2. 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

3. 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 (EMS),
TS (US Automotive) etc.

4. 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

6. 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

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

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

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

11. Main Chemical Targets
LEAD
PHTHALATES

12. 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)

13. 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

14. 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.

15. 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.

16. 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.

17. 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”

18. 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.

19. 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
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.

20. Third-Party Testing of Children’s Products

21. What Regulations Apply to Children’s Products ?

24. Rattle Third-Party Certification
What tests need to be done by the accredited third-party lab?
16 C.F.R 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

25. Manufactured December 22, 2008  Certify to lead paint ban
Rattle Third-Party Certification Timeline
Manufactured December 22,  Certify to lead paint ban
Manufactured April 4,  Certify to lead paint ban and small parts regulations
Manufactured August 29,  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 . . .

26. “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

27. Third-Party Certification
Timeline
Manufactured on December 22, 2008  Certify to 600 ppm lead paint ban
Manufactured on August 29,  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 F et al.

28. 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

29. 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

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

31. 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

32. 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
200.9
239.2
EPA-EAD
1638
Standard Methods
3500-Pb B
Spectrophotometer
Sampling/Preparation
B (ICP-MS)
ANIMAL TISSUE
1640
1637
D6502
XRF
3111B
B (ICP-AES)
also Soil / Air methods
all charge $40 to $400 US per sample

33. Lead Test Method Sources
AOAC
EPA
USGS
ASTM
Standard Methods
CPSC

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

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

36. Testing for Phthalates in Consumer Products

37. 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

38. Evaluating Consumer Products for Phthalates
CPSC Staff Method:
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:

39. Alternate Methods - Phthalates

40. Sample Preparation for Phthalate Testing

41. Testing Issues for Phthalates
See FAQ at
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

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

43. 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

44. 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 accreditation at least for key testing technologies

45. QUESTIONS ???