CPSC experts and representatives of a law firm used this presentation to discuss testing and certification issues, component parts testing, and certificates of conformity.
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2012 Safety Academy: Testing and Certification
1. Panel on Testing-2012
• Safety Academy
Mr. Randy Butturini CPSC Office of Hazard Identification &
Reduction
Ms. Mary House CPSC Office of General Counsel
Mr. Quin Dodd Quin Dodd LLC
2. U.S. Consumer Product Safety
Commission
The Basics of Required Consumer Product
Testing and Certification
Randy Butturini Mary House
EXHR OGC
This presentation was prepared by CPSC staff, has not been reviewed or
approved by, and may not reflect the views of, the Commission. 2
3. CPSC Testing & Certification
Requirements
• All regulated consumer products must be tested
and certified as compliant with applicable rules.
• Testing regime broken into two categories:
– Non-Children’s Products
– Children’s Products
• Only children’s products require third party
testing.
3
4. CPSC Testing & Certification Requirements
No testing or certification is required
for
products that are not subject to a
consumer product safety rule.
4
5. What Law Governs Testing & Certification
of Non-Children’s Products?
Statutory Requirements:
•Section 14(a)(1) of the CPSA – Requires regulated products to be
certified based on a test of each product or a reasonable testing
program.
•Section 14(g) of the CPSA – Provides certificate content and
availability requirements.
5
6. What Law Governs Testing & Certification
of Non-Children’s Products?
Regulatory Requirements:
•16 CFR part 1109 – Provides for component part testing and
reliance on another party’s testing or certification.
•16 CFR part 1110 – Sets forth Commission’s rules on certificate
content and availability.
6
7. What Testing Requirements Exist for
Non-Children’s Products?
Regulated non-children’s products must be tested and
certified to meet applicable standards.
Certification must be based on a test of:
– each product; or
– a reasonable testing program.
Third Party Testing is NOT Required.
Testing parties may conduct testing themselves or use an
outside testing laboratory.
7
8. What Testing Requirements Exist for
Non-Children’s Products?
Reasonable Testing Program (RTP)
• Some standards contain an RTP for their products.
• General RTP for all regulated non-children’s products has not
been defined by the Commission.
Model of an RTP for non-children’s products:
• Notice of proposed rulemaking for testing and labeling
pertaining to certification at 75 FR 28336, 28362 (May 10, 2010):
http://www.gpo.gov/fdsys/pkg/FR-2010-05-20/pdf/2010-11365.pdf.
8
9. Example: Testing & Certification
Requirements for an Adult Bicycle
1. Determine whether this product is regulated by the CPSC.
– http://www.cpsc.gov/businfo/regsbyproduct.html
2. List all applicable rules.
– 16 CFR part 1512
9
10. Example: Testing & Certification
Requirements for an Adult Bicycle
3. Arrange for testing (test each unit or test using a reasonable
testing program).
– First party test (you);
– Third party test (someone else);
– Third party test (testing laboratory); or
– Third party test (CPSC-accepted testing laboratory).
– Component part testing can be used by anyone.
10
11. Example: Testing & Certification
Requirements for an Adult Bicycle
4. Collect test reports and other information in a certificate.
5. “Enter into Commerce.”
11
12. What Is a Children’s Product?
Only children’s products subject to a children’s product safety rule
are required to be tested by a third party laboratory and certified.
Children’s Product – designed or intended primarily for children 12
years of age or younger. Consider four factors for age determination:
• Statement by a manufacturer regarding intended use of a
product, including labeling;
• Whether product packaging, display, promotion, or advertising
represents appropriate for use by children 12 and under;
• Whether product recognized by consumers as intended for
children 12 years and younger; and
• Age Determination Guidelines for toys and play,
http://www.cpsc.gov/BUSINFO/adg.pdf.
Commission’s Interpretation – 16 CFR part 1200
12
13. What Law Governs Testing & Certification
of Children’s Products?
Statutory Requirements:
•Section 14(a)(2) of the CPSA – Requires children’s products
subject to a children’s product safety rule to be certified based on
testing conducted by a CPSC-accepted third party laboratory.
•Section 14(i)(2)(B) of the CPSA – Requires periodic and material
change testing.
•Section 14(g) of the CPSA – Provides certificate content and
availability requirements.
13
14. What Law Governs Testing & Certification
of Children’s Products?
Regulatory Requirements:
•16 CFR part 1107 – Sets forth requirements for certification,
material change, and periodic testing of regulated children’s
products.
•16 CFR part 1109 – Provides for component part testing and
reliance on another party’s testing or certification.
•16 CFR part 1110 – Sets forth Commission’s rules on certificate
content and availability.
14
15. What Testing Requirements Exist for
Children’s Products?
Children’s products are subject to three types of third party
testing under the rule:
• Certification Testing;
• Material Change Testing; and
• Periodic Testing.
15
16. What Testing Requirements Exist for
Children’s Products?
Certification Testing – 16 CFR § 1107.20
Who needs to test?
• Manufacturers, including importers, must submit samples to
be tested to applicable standards by a CPSC-accepted third
party laboratory listed on our website at:
http://www.cpsc.gov/cgi-bin/labsearch/
What gets tested?
• Sufficient number of samples, or samples that are identical
in all material respects to the finished product, or to
component parts used in the finished product. 16
17. What Testing Requirements Exist for
Children’s Products?
Certification Testing – 16 CFR § 1107.20
When does testing need to be done?
• Before importing product for consumption or warehousing or
distributing in commerce.
Why conduct the tests?
• To provide a high degree of assurance that the samples
selected and the tests conducted for certification purposes
accurately demonstrate the ability of the children’s product to
meet all applicable children’s product safety rules.
17
18. Example: Testing & Certification
Requirements for Children’s Raincoat
1. Determine whether this product is regulated by the CPSC.
– http://www.cpsc.gov/businfo/regsbyproduct.html
2. List all applicable rules:
– 16 CFR part 1611
(vinyl plastic film)
– Section 101 of the CPSIA
(lead content)
18
19. Example: Testing & Certification
Requirements for Children’s Raincoat
3. Arrange for testing by a CPSC-accepted testing laboratory.
Different CPSC-accepted laboratories may be used for different
tests.
– http://www.cpsc.gov/cgi-bin/labsearch/
– Component part testing can be used for certification testing.
19
20. Example: Testing & Certification
Requirements for Children’s Raincoat
4. Collect test reports and other information in a CPC.
5. “Enter into Commerce.”
20
21. What Testing Requirements Exist for
Children’s Products?
Material Change Testing – 16 CFR § 1107.23
What needs to be tested?
•May test only the changed component part unless the changed
part could effect the entire product’s ability to comply with
applicable rules (e.g., small parts testing).
•The number of samples submitted must be sufficient to provide
a high degree of assurance that the materially changed
component part or finished product complies with the
applicable children’s product safety rules.
(Remember, component part testing is available for all testing.)
21
22. What Testing Requirements Exist for
Children’s Products?
Material Change Testing – 16 CFR § 1107.23
Material change testing requires third party testing of the
materially changed part or product, and reissuing the Children’s
Product Certificate.
What is a material change?
A material change in a product is a change:
• in the product design or manufacturing process, including the
sourcing of component parts,
• which a manufacturer exercising due care knows, or should know,
could affect the product’s ability to comply with the applicable
children’s product safety rules.
22
23. What Testing Requirements Exist for
Children’s Products?
Periodic Testing – 16 CFR § 1107.21
Periodic testing must provide a high degree of assurance that
products manufactured since certification or the last periodic
tests are compliant.
(Remember, component part testing is available for all testing.)
23
24. What Testing Requirements Exist for
Children’s Products?
Periodic Testing – 16 CFR § 1107.21
Maximum testing intervals:
•One year;
•Two years with a production testing plan; or
•Three years using a testing laboratory accredited to
ISO/IEC 17025:2005(E).
Recertification and material change testing can “reset” the
periodic testing interval.
24
25. How Can I Use Component Part Testing?
Component Part Testing
non-children’s products
children’s products
25
26. How Can I Use Component Part Testing?
Component Part Testing Rule – 16 CFR part 1109
•Allows testing on component parts by any party.
•Testing component parts of a product is voluntary.
•Only finished products are required to be certified.
26
27. How Can I Use Component Part Testing?
Required certifiers (importers or domestic manufacturers) can
rely on any combination of the following to certify a non-
children’s or children’s finished product:
• Component part test report(s);
• Finished product test report(s);
• Component part certificate(s); or
• Finished product certificate(s).
27
28. How Can I Use Component Part Testing?
A finished product certifier relying on another party’s testing or
certification must exercise due care, which includes access to
required records (ref. section 1109(g)).
28
29. What Certification Requirements Exist for
Regulated Products?
General Conformity Certificates (GCCs) –
non-children’s products
Children’s Product Certificates (CPCs) –
children’s products
29
30. What Certification Requirements Exist for
Regulated Products?
Certificates must be issued by:
•Importer - products made outside the U.S.; or
•Domestic manufacturer - products made in the U.S.
30
31. What Certification Requirements Exist for
Regulated Products?
Certificates are not filed with CPSC. However, they must be
furnished to CPSC or CBP upon request.
Regulated products or shipments of regulated products must be
accompanied by a certificate.
A copy of the certificate must also be furnished to distributors
and retailers. No requirement exists to provide certificates to
consumers.
Certificates can be hard copy or electronic.
31
32. What Certification Requirements Exist for
Regulated Products?
Certificate Content Requirements:
•Identification of the product(s);
•List each applicable consumer product safety regulation;
•Identification of the certifying importer or domestic
manufacturer;
•Contact information for the individual maintaining records of
test results;
•Date(s) and place(s) where this product was manufactured;
•Date(s) and place(s) when the product was tested for
compliance with each safety rule;
•Identification of any third party laboratory on whose testing the
certificate depends.
32
33. What Certification Requirements Exist for
Regulated Products?
For Examples and Additional Information
on GCCs: http://www.cpsc.gov/BUSINFO/gcc.html
on CPCs: http://www.cpsc.gov/businfo/cpc.html
33
34. Are There Any
Testing or Certification Exclusions?
Small Batch Manufacturers – 14(i)(4) of the CPSA
• Must Register on CPSC’s Website – www.saferproducts.gov
• Exclusion From Some Third Party Testing Requirements
• Must Certify Compliance
Ordinary Books and Paper-Based Materials
• Do Not Require Third Party Testing
• Must Certify with General Certificate of Compliance
34
35. Are There Any
Testing or Certification Exclusions?
Metal Bicycle Components
•Exempt from third party lead content testing, but must be compliant to 300
ppm by weight.
•Not exempt from third party testing to the bicycle standard or any other
applicable rule.
•Must Certify Compliance.
ATVs
• ONLY excluded from testing & certifying to the 100 ppm lead
requirement.
35
36. Are There Any
Testing or Certification Exclusions?
Exempt from Certification and Testing
• Inaccessible Lead Component Parts (§ 1500.87).
•Electronic Component Parts (§ 1500.88).
•Materials determined not to exceed the lead content limits of
section 101(a) of the CPSIA (§ 1500.91).
•Inaccessible plastic component parts on children’s toys and
childcare articles are not required to be third party tested or
certified to meet phthalate content limits in section 108 of the
CPSIA.
36
37. Further Information
CPSIA:
http://www.cpsc.gov/about/cpsia/cpsia.html
Small Business Ombudsman:
http://www.cpsc.gov/businfo/smbus.html
37
38. Practical Implications and Recommendations
For Complying With
The CPSC Testing and Certification and
Component Part Testing Rules
CPSC “Safety Academy”
September 20, 2012
Quin Dodd, Esq.
Law Offices of Quin D. Dodd, LLC
quin@quindoddlaw.com
39. Law Offices of
Quin D. Dodd, LLC
Testing and Certification Rule--Required Documents
(Mandatory For Children’s Products Made After 2/08/13):
1. Certificates (CPCs) (practically including test reports)
2. Production/Periodic Test Plan at each manufacturing site:
- Tests to be conducted and testing interval during production;
- Procedure used to select “representative” samples for periodic testing and
justification for number of samples selected;
- How these and other factors (esp. manufacturing processes and
conditions) impart a “HDOA” of continued compliance.
1. Sample failure response (remedial actions undertaken)
2. “Material changes” and responses thereto (probably requires a
product specification—list of components, materials, etc.)
3. Undue Influence policies and training docs
4. If no Periodic/Production Test Plan, otherwise document HDOA
5. Records must be kept for 5 years and provided (translated if
necessary) to CPSC within 48 hours of request. (May want to be in
local factory language to ensure understood and employed).
40. Law Offices of
Quin D. Dodd, LLC
Component Part Testing Rule--Required Documents
(For All Products Subject to a Mandatory CPSC Standard Today;
But Note the Rule is Voluntary):
1. Identification of the component/product tested, including lot/batch number
or other “information sufficient to identify the component parts or finished
products”
2. Identification of applicable CPSC standards
3. Identification of test methods and sampling protocols used
4. Date/date range when component/product tested
5. Test reports, with test values (e.g., lead or phthalates ppm)
6. Component/finished product certificate, (if supplier is certifying)
7. Traceability: Identification of parties ordering tests; parties conducting tests
and direct link of those tests to specific components/finished products
8. Attestations (typically 3) by each supplier and IOR/DM supplier that “due
care” as exercised to ensure continued compliance while component/product
was in that company’s custody; and by lab that it followed correct
testing/sampling procedures
9. Memo or other document explaining Due Care is advisable
41. Law Offices of
Quin D. Dodd, LLC
What’s Likely to Happen?
• US Importers (esp. retailers) likely to require compliance with
Testing and Certification Rule (CPCs for received components
and/or products) by their (US and/or overseas) suppliers.
• US Suppliers and overseas factories will likely then have burden of
compliance (actions plus documents) with Testing and Certification
and, practically speaking, Component Part Testing Rules…(“Dear
Supplier: Effective February 8, 2013…”).
• Default choice likely to be (should be) annual periodic testing
w/”Production Testing Plan” (HDOA factors plus “some testing).
• “Batch certification” “exception” to Periodic/Production Testing will
likely be utilized, BUT HDOA still required.
42. Law Offices of
Quin D. Dodd, LLC
What Is An IOR/DM To Do?
• Categorize your products and determine which
standards/testing apply.
• Develop conscious, written testing protocols and
supplier requirements—they can form the basis for docs
required under CPSC Testing & Cert/Component Part
Rules, and they are smart in any case.
• Rely, wherever possible, on component testing and
supplier certification of components/finished products.
• Maximize all available flexibilities to reduce testing
costs (e.g., materials exempt from lead/phthalates
testing; alternative test methods where available, etc).
43. Law Offices of
Checklist to Reduce Testing Costs: Quin D. Dodd, LLC
• Are you a “small batch manufacturer”?
• Are your products in fact “children’s products”?
• If they are children’s products, are they exempt from toy;
lead; phthalates; and small parts standards (and sharp
points/edges and flammability tests)?
• Are your products/components/materials exempt from
lead/phthalates testing?
• Are you maximizing “component” testing/certification?
• Are you ordering most cost-effective testing/methods?
• Do you have your own checklist to make sure all
standards and testing and certification requirements are
being met?
44. Consumer Product Safety
•
Commission
Mr. Dean W. Woodard U.S. CPSC
Director Office of Education, Global Outreach, and Small
Business Ombudsman
dwoodard@cpsc.gov
business@cpsc.gov
Editor's Notes
09/25/12 This presentation was prepared by CPSC staff, has not been reviewed or approved by, and may not reflect the views of, the Commission.
09/25/12 This presentation was prepared by CPSC staff, has not been reviewed or approved by, and may not reflect the views of, the Commission.
09/25/12 This presentation was prepared by CPSC staff, has not been reviewed or approved by, and may not reflect the views of, the Commission.