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Guidance Document:
Testing and Certification Requirements Under the Consumer Product Safety Improvement
Act of 2008
A reasonable testing program is a set of procedures that are employed to provide
reasonable certainty that products made are in compliance with all applicable rules,
bans, and standards. The minimum essential elements are:
(1) Product specifications that describe the consumer product and list the safety
rules, standards, etc., with which the product must comply;
(2) Certification tests, which are performed on samples of the manufacturer's consumer
product to demonstrate that the product is capable of passing the tests prescribed
by the standards;
(3) A production testing plan, which describes the tests that must be performed
and at what intervals as long as the consumer product is being manufactured to provide
reasonable assurance that the products as produced continue to meet all applicable
safety rules;
(4) Remedial action plans, which must be employed whenever samples of the consumer
product or results from any other tests used to assess compliance yield unacceptable
or failing test results; and
(5) Documentation of the reasonable testing program and how it was implemented.
The CPSC expects that any general conformity certificate will be based upon a testing
program that, at a minimum, includes these five elements.
Merriam - Webster Dictionary
Main Entry: rea•son•able
Pronunciation: \ˈrēz-nə-bəl, ˈrē-zən-ə-bəl\
Function: adjective
Date: 14th century
1 a : being in accordance with reason - a reasonable theory b : not extreme or excessive
- reasonable requests c : MODERATE, FAIR - a reasonable chance - a reasonable price
d : INEXPENSIVE
2 a : having the faculty of reason b : possessing sound judgment - a reasonable
man
Consumer Product Safety Commission
- CPSIA home page
The Consumer Product Safety Improvement Act (CPSIA) is a law that expanded upon
the CPSA. The CPSIA requires specific testing methods for determining lead and other
heavy metals in children’s products, and further requires certification of testing
by a third party approved laboratory.
Currently, there is a stay on the enforcement of certain testing requirements and
certification, until 2/10/11. Certain testing of children’s products are not stayed
and need to be certified by third-party accredited laboratories; lead in paint,
small parts, cribs, pacifiers and children’s metal jewelry. All children’s products
must meet the required limits for lead and other metals, but only those mentioned
above need to be tested by a CPSC-recognized third-party conformity assessment body.
The current approved testing methods required are destructive in nature and expensive.
Regardless, manufacturers, importers and retailers must ensure that their products
comply with the regulations.
Anyone who manufactures or imports products designed and marketed to children 12
years of age or younger, as well as, non-children’s products as regulated by the
Consumer Product Safety Improvement Act (CPSIA). These requirements can include
testing for lead and other elements, phthalates in certain products and the facilitation
of a General Certificate of Conformity (GCC).
A non-destructive, “End to End” Reasonable Testing Program (RTP). A step by step
reasonable approach to testing and providing data needed for the GCC. This includes
an initial consultation, testing, screening, data analysis and report generation
capabilities, including GCC and generalized reports. Our software will permit you
to enter data after testing is complete your GCC.
We need to define a reasonable testing program for your company and products. A
reasonable testing program is a set of procedures that are employed to provide reasonable
certainty that products made are in compliance with all applicable rules, bans,
and standards.
Our RTP provides reasonable assurance that the product meets all requirements of
elemental standards. We specialize in elemental and a specific chemical regulation
from the requirements of the standard.
Our consultation includes:
- A discussion about our products
- The CPSIA regulations (elemental rules and standards) and testing methods
- XRF Technology and how elements are verified and measured
- Our software and how we perform testing and data collection
- Component testing and batch testing v. finished product testing
- XRF v. Traditional Testing methods and standards
- A remedial action plan – what happens when we find a regulated element(s)
- Your requirements of a production testing plan, intervals of testing
Based on this consultation, your company may decide to proceed with testing.
Based on the definition of our reasonable testing program and knowledge from our
discussion in the consultation, testing can begin. This will include X-Ray Fluorescence
(XRF) Analyzers, photography, and computer software and data collection. Depending
on the test results, further testing may be reasonable to perform including Phthalate
Screening and Phthalate Testing
XRF Based elemental analysis is a non-destructive testing platform designed to look
at the elemental makeup and provide spectral analysis of virtually anything. Our
program includes total content testing for lead, cadmium, arsenic, mercury, antimony,
selenium, chromium and barium which are all elements from the ASTM-963 standard
soluble test. We utilize a common sense approach too effectively, efficiently and
inexpensively target components of children’s products.
By using an XRF analyzer, we can quickly determine if the product tested has any
restrictive elements present in it. Combining a systematic approach of testing with
data collection, we can provide data about all components tested. Our program stresses
this component testing, with each new batch of that component tested.
Considering that XRF provides total content analysis, and can prove if elements
are present or not present, we use a logical approach to testing
and elemental standards.
When testing if we do not find lead within the spectrum detail, this test would
provide reasonable certainty that lead is not present. However, when testing, if
we find lead within the spectrum detail, it would be reasonability certainty that
lead is present. Without regarding the amount of lead, the spectrum detail can provide
reasonability certainty that lead is present or not present.
The same can be said about all eight elements that a part of the regulation (antimony,
arsenic, barium, cadmium, chromium, lead, mercury and selenium). Using the spectrum
simply to determine if the elements are present or not present can be a reasonable
method to determining if further testing should be required, the example: if we
are looking for cadmium and we do not find any cadmium within the spectrum detail,
do further destructive testing should be required. However, if we do find cadmium,
further testing may be needed to give reasonability certainty.
If we use a quantitative approach with XRF we can provide a reasonable estimate
of the total content within the product tested, as well as, to soluble content regulations.
An example is the soluble content of lead at 90 PPM under the ASTM-F963 regulation
(but this example can apply to all elements). If we test a product and find lead
present, but only a total content level of 50 PPM, how is it possible that there
is more leeching out (soluble) when no more exists? There are questions as to the
reliability of the quantification with XRF, but once again, combining these two
methods can give reasonable certainty of the elements present within the items.
Quantitative Approach
We use a stricter standard than the CPSIA regulation and base our results on the
following standard limits.
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Element
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Our Limit Standard
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ASTM-F963 (Soluble Limit Standard)
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Arsenic
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20 PPM
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25 PPM
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Antimony
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50 PPM
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60 PPM
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Mercury
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50 PPM
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60 PPM
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Chromium
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50 PPM
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60 PPM
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Cadmium
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50 PPM
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75 PPM
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Lead
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75 PPM
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90 PPM
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Selenium
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400 PPM
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500 PPM
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Barium
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800 PPM
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1000 PPM
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In theory, if the total content amount found is less than the ASTM-F963 limit (the
leachable amount) it would be impossible for more to exist in total content. As
of August 14th, 2009 the CPSIA regulations will permit 300 PPM or less of lead in
a children’s product, XRF analyzers can detect as little as 10 PPM.
If elements are found above our limits, it would be reasonable for additional, more
traditional, destructive testing to be applied. This would require the use of a
third party, independent laboratory that uses various acids to digest the materials
and provide data. However, if you, the manufacturer decide that our results are
conclusive, it would be prudent to change the materials used in the manufacturing
process and re-test that specific failed component by using XRF. Repeat this process
as necessary.
Upon completion of testing, analysis of the data and phthalate screening would begin.
Phthalate Pre-Screening essentially is the discovery of Polyvinyl Chloride
(PVC) and is determined by the amount of Chlorine detected by the analyzer. PVC
can potentially contain phthalates. Phthalates are chemicals that are added to PVC
to make them softer and more pliable. If PVC is not detected it is reasonable to
state that no phthalates are present. If phthalates are potentially present, it
would be reasonable to do further phthalate screening.
Phthalate Screening is the use of a Fourier Transform Infrared Spectroscopy
(FTIR) machine to look for organic compounds, such as chemicals like phthalates.
If phthalates are not found using FTIR, it would be reason to state that no phthalates
are present, however, if phthalates are found, further phthalate testing would be
suggested to identify which phthalates are present and in what quantities.
Phthalate Testing involves the use of a third party laboratory that uses
a Gas Chromatography (GC) machine to identify and quantify chemicals. This is a
destructive form of sampling.
We provide you with a software solution package that gives you the ability to review
each test, see the elements detected, view them in the spectrum, create reports
and produce your General Certificate of Conformity.
Unlike other testing methods, our use of XRF Analyzers (and potentially FTIR machines)
is a non-destructive form of testing. Upon completion of testing, we will return
any products to you (shipping expenses are the clients responsibility) and suggest
that you keep and store these sample products in a safe location. Additionally,
it is recommended that you keep a copy of your test results with these items.
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