Opportunities and Requirements in CFR 16 Safety Testing of USA Consumer Goods and Laboratory Accredi

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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

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ANSI-ASQ National Accreditation Board
Certification Bodies - ISO/IEC 17021 Accreditatio
n for Management System Certification Bodies
that certify to ISO 9001 (QMS), ISO 14001
(EMS), TS 16949 (US Automotive) etc.
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
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International Recognition
ACLASS (USA) A2LA (USA) IAS (USA) L-A-B
(USA)NVLAP (USA) Asia-Pac Countries
European Bodies
ACLASS (USA) A2LA (USA) South AmericaCentral
AmericaMexico
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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

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2008 USA Legislation

• Consumer Products Safety Improvement Act

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Key Provisions of CPSIA

• TITLE I CHILDRENS PRODUCT SAFETY
• Section 101. Childrens products containing
  lead lead paint rule.
• Section 102. Mandatory third party testing for
  certain childrens products.
• Section 103. Tracking labels for childrens
  products.
• Section 104. Standards and consumer
  registration of durable nursery products.
• 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.
  

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Main Chemical Targets

• LEAD
• PHTHALATES

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LEAD Issues

• Lead poisoning known for gt 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 gt 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)

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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

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Mandatory Third-Party Testing for Certain
Childrens Products
CPSC Public Meeting -- October 2, 2008 This
presentation has not been reviewed or approved by
the Commission and may not reflect its views.
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• Definition of Childrens Product
• The term childrens product is defined as a
  consumer product designed or intended primarily
  for children 12 years of age or younger.

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• What is a Childrens Product?
• In deciding what is a childrens 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.

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• Who Must Certify?
• Every manufacturer of such childrens product
  (and the private labeler of such childrens
  product if such childrens 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

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• Is Third-Party Testing Required for All
  Childrens Products?
• The requirement for third-party testing
  applies to every childrens product that is
  subject to a
• childrens product safety rule
• The term childrens 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.

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• Methods for Third-Party Testing of Childrens
  Products
• Method for third-party testing depends on the
  standard, ban or similar rule applicable to the
  childrens product
• Ban on Lead-Containing Paint
• http//www.cpsc.gov/BUSINFO/leadsop.pdf
• http//www.cpsc.gov/BUSINFO/Recht.pdf
• Many of the Commissions 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.

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Third-Party Testing of Childrens Products
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What Regulations Apply to Childrens Products ?
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• 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

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• 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 childrens product safety rules
  includes all of the above plus phthalates, F963,
  the rattle test method . . .

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• 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

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• 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.

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Phthalates Definitions and Testing ( Permanently
Banned Phthalates ) Childrens 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
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Phthalates Definitions and Testing . . . any
childrens toy that can be placed in a childs
mouth or child care article . . . For
purposes of this section a toy can be placed in a
childs 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
childrens 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
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Childrens Product vs. Childrens Toy for
Phthalates Certification
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• 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

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Lead Test Method Sources

• AOAC
• EPA
• USGS
• ASTM
• Standard Methods
• CPSC

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Lead Testing Technologies

• ICP AES
• ICP MS
• FLAA
• Spectrophotometric
• XRF (X-ray)

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CPSC Phthalate Information

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

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Testing for Phthalates inConsumer Products
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• 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

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Evaluating Consumer Products for Phthalates CPSC
Staff Method http//www.cpsc.gov/about/cpsia/phth
alatesop.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_at_cpsc.gov
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Alternate Methods - Phthalates
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Sample Preparation for Phthalate Testing
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• Testing Issues for Phthalates
• See FAQ at http//www.cpsc.gov/about/cpsia/faq/
  faq.htmlsect108
• 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
  childrens 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

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Identifying Phthalates Some of the regulated
phthalates are complex mixturesand share
similarities with non-regulated phthalates care
must be used to identify
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• 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

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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

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QUESTIONS ???