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


ANSI-ASQ National Accreditation Board. Laboratories ISO/IEC 17025 ... Spectrophotometer. Sampling/Preparation. USGS-NWQL. B-9001-95 (ICP-MS) Lead and lead cmpds ... – PowerPoint PPT presentation

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Title: 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
  • Bill Hirt, Ph.D.
  • ACLASS Sr. Accreditation Manager
  • Guatemala SERVICE SUMMIT September, 2009

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
International Recognition
(USA)NVLAP (USA) Asia-Pac Countries
European Bodies
ACLASS (USA) A2LA (USA) South AmericaCentral
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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
  • 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
  • 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
  • Section 108. Prohibition on sale of certain
    products containing
  • specified phthalates.

Main Chemical Targets
  • LEAD

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
  • 2007 study showed Lead test kits unreliable (from
    CPSC with false s and false s)

  • 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
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.
  • 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.

  • 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
  • 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 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

  • 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.

  • Methods for Third-Party Testing of Childrens
  • 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.

Third-Party Testing of Childrens Products
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

  • 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 . . .

  • 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
  • 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 ) 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
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
Childrens Product vs. Childrens Toy for
Phthalates Certification
  • Going Forward
  • Know your product and its constituent
  • 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

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Lead Test Method Sources
  • AOAC
  • EPA
  • USGS
  • ASTM
  • Standard Methods
  • CPSC

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

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

Testing for Phthalates inConsumer Products
  • Evaluating Consumer Products for Phthalates
  • Total Phthalate Content in Toy or Child Care
  • 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/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
Alternate Methods - Phthalates
Sample Preparation for Phthalate Testing
  • Testing Issues for Phthalates
  • See FAQ at http//www.cpsc.gov/about/cpsia/faq/
  • 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
  • Composite testing

Identifying Phthalates Some of the regulated
phthalates are complex mixturesand 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
  • 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

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