New CPSC Testing and Certification Requirements: How Far Have We Come?

New CPSC Testing and
Certification Requirements:
How Far Have We Come?
Presented by AAFA and Intertek

October 17, 2012
1 © Intertek 2012, www.intertek.com

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Presenters
Michael McDonald
American Apparel & Footwear Association
Government Relations Representative
Joseph Mohorovic
Intertek, Consumer Goods North America
Senior Vice President

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How Far Have We Come?
• H.R. 2715
• Time Line
• Recommendations
• CPSC Approved Actions
• Next Steps

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What Did H.R. 2715 Do?
Testing
• Changes testing requirements
from random to representative
• Requires CPSC to assess
opportunities for granting relief
from third party testing.
• Allows alternative certification
requirements for small batch
manufacturers
• 10,000 units per year
• 1,000,000 in gross revenue

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H.R. 2715 Timeline
8/12/2011 - Signed by the President

11/8/2011 - Request for comments on testing
reduction
1/23/2012 – Comment period ends
4/10/2012 – XRF test method published
6/26/2012 – Random Vs. Representative vote
8/29/2012 – Testing reduction briefing package
released
10/10/2012 – Vote on testing reductions

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Where are We Now?
Waiting

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Reducing the Cost of Testing
H.R. 2715 tells the CPSC to:

• The Commission shall seek public
comment
• Prescribe new or revised third party testing
regulations
• Report to Congress reviewing opportunities
it “lacks the authority to implement”

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What Did We Recommend
 . No Testing = No GCC χ . More preemption over states is needed

χ . Sleepwear is not a child care χ . Solution to test variability is needed
article
. XRF can be used as a screening tool
χ . CPSIA does not apply to 16 CFR . All small batches deserve an exemption
1610
χ . Inaccessibility exemption for lead in
χ . Lead will not be found in “prints” paint
χ . Decision on phthalates is needed χ . Fabric can be an inaccessible barrier
χ . Periodic testing does not need to . Risk should always be the #1 priority
be third party

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What Was Accepted
• International Standards Equivalency • Determinations Regarding Synthetic

to Children’s Product Safety Rules Food Additives
• Third Party Exemptions for Low • Determinations Regarding Heavy
Volume Batches Metals
• Guidance Regarding Periodic • Accreditation of Certain Certification
Testing and Periodic Testing Plans Bodies
• Fourier Transform Infrared • Determinations Regarding Adhesives
Spectroscopy (FTIS) in Manufactured Woods
• Determinations Regarding
Phthalates

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What Happens Next
• Revote on Random vs. Representative

• Staff research on proposed testing
reductions
• February date for Testing and
Certification Rule

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State Product Safety Requirements
• Washington State – Children’s Safe

Product Act
• Maine – Toxic Chemicals in Children’s
Products
• California
• Prop 65
• Green Chemistry

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CPSC Testing and
Certification Requirements

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Topics for Discussion
I. Basic U.S. Children’s Safety

Requirements
II. Testing and Certification Rule
III. Component Part Testing Rule
IV. Traceability
V. Flammability and the Testing Rule
Appendix A: Common Acronyms
Appendix B: Step-by-step Guide

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I. What testing and certification is
required for “children’s products”?
- U.S. importer/Domestic manufacturer (DM) must have a CPSC-

approved third party test report covering all applicable mandatory
standards;
- US importer/DM must certify (issue a Children’s Product Certificate
“CPC”) for the product to all applicable standards, based on the third
party test report(s);
- Beginning February 8, 2013, U.S. importers/DM must also undertake
certain other activities and keep certain other records OR must have
their overseas supplier undertake this (CPSC Testing and
Certification Rule);
- If the U.S. importer relies on the overseas supplier to comply with the
Testing and Certification Rule, that importer must also maintain
certain other documents under the Component Part Testing Rule
(follows).

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II. Testing and Certification Rule:
Overview of Requirements
Required (Mandatory) for Children’s Products Manufactured After

February 8, 2013.
4 Key Elements:
1. Certification testing
2. Periodic Testing/Production Testing Plan
3. Material Change requires retesting
4. Undue Influence policies and training
• All above must provide certifier with a “High Degree of Assurance” (HDOA)
of compliance with standards.
• Products must be certified on a per factory basis. (The same product
produced at two manufacturing locations will require separate
certifications.)
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Certification
• Certificate information same as today:

http://www.cpsc.gov/businfo/cpc.html.
• Title of certificates not important: GCC, CPC or COC.
• For children’s products (CPC), certification must be based on
CPSC-approved third party lab test report.
• Samples must be of sufficient number to impart HDOA:
Differentiate between quantitative and qualitative testing.
• Samples must be “identical in all material respects” to final
product—essentially same notion as “representative samples” (no
“golden samples”).
• A single sample failure requires investigation and possible remedial
action which could include recertification—must restore HDOA.

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Periodic/Production Testing (PTP)
• “Periodic” (third party lab) and/or “Production” (in house) testing required to
ensure continued product compliance after certification testing. Three options:
1. Default is annual third party retesting during production (manufacture) of the
product.
2. Third party testing every two years if also doing Production Testing (“Production
Management Techniques,” plus some type of in-house testing or third party testing,
e.g., XRF testing for lead).
3. Third party testing every three years if also doing in-house ISO-certified lab testing.
• Periodic (or Production) Testing Plan, document required for each factory/site
where product is made, and must specify:
1. Testing interval
2. Tests conducted (to which CPSC mandatory standards)
3. Sampling Procedure used to select test samples
4. “Production management techniques”

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II. Testing And Certification Rule:
Periodic vs. Production Testing
Periodic Testing 1. Periodic 2. Production 3. In-House Production

Testing by ISO-
Options Testing Testing Accredited Lab
1. Quality Management High Degree of

Frequency of in- None System Use
Assurance (HDOA) of
house testing 2.
3.
Product risk
Manufacturing process continued product
based on: variability
compliance
Frequency of 3rd Party At least annual None or every 2 years None or every 3 years
Periodic Testing:
Frequency of 3rd Nine factors: §1107.21(b)(2)(i-ix) Production Production

• Test result variability
• Results close to limit
Party Testing • Mfr process factors Testing Results Testing Results
• Consumer complaints
based on: • Injury potential
• High volume
• Visually undetectable
noncompliance
Same as certification testing: Alternative methods Same as certification testing:

Methods CPSC approved methods only allowed CPSC approved methods only
1. Tests conducted 1. Process mgmt techniques 1. In-house ISO-accredited

Test plan 2. 3rd Party test results 2. Tests conducted Production Testing results
3. Intervals 3rd Party test results (if
recordkeeping 3. Testing intervals 4. # of samples
2.
applicable)
4. # of samples tested 5. Basis for HDOA
6. Production Testing results
7. 3rd Party test results (if
applicable)

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Material Change
• Triggered by change in:

1) Design;
2) Manufacturing process; or
3) Suppliers (of raw materials or finished parts/products)
• Material Change is something that might impact compliance with a CPSC
mandatory standard
• Requires new third party testing and recertification (but only for CPSC
standards potentially impacted by change)
• Effectively requires a Product Specification/Bill of Materials

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Undue Influence
• “Undue influence” means attempting to force a lab to obtain a

desirable (passing) test report.
• Must maintain written policy against undue influence.
• “Appropriate staff” must be trained and attest to having received
training.
• Must have written policy to “immediately” notify CPSC of attempts to
“hide or exert undue influence over test results.”
• No CPSC training program or other specific guidance (you can
develop your own training).

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What Records Must Be Kept?
1. Certificates (CPCs), including product test reports

2. Periodic/Production Testing Plan (PTP) and results
3. Sampling Procedure used to select “representative”
samples for certification and periodic/production testing
4. Actions taken in response to a test sample failure
5. Material Changes and responses thereto
6. Undue Influence policies and training
7. All records must be kept for 5 years and provided (and
translated into English, if necessary) IF the CPSC asks for
the records
Beginning February 2013, a technical file will need to be
produced and maintained for most children’s products sold in
the U.S.

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What is a “High Degree of Assurance”?
• HDOA defined as “evidence-based demonstration of consistent

performance of a product regarding compliance based on actual
knowledge of product and manufacturing process.”
• Specifically required for:
- Number of samples submitted for certification and periodic testing
- Frequency of periodic testing
- Elements of production testing plan
• HDOA may be based on some combination of statistical assurance,
process controls, design validation, Good Manufacturing Practices, ISO
Guides 65 and 67, or “other knowledge of product and its manufacture,”
and must include some testing/measurement.

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III. Component Part Testing Rule:
NOW In Effect!
• Rule is VOLUNTARY and mostly applies to precertification for U.S.

importer of record (IOR) for children’s products
• U.S. importer may issue a certificate (CPC) based on component/final
product test reports or certificates
• There are 4 options if U.S. importer chooses to utilize this rule:
1. IOR certifies based (in whole or in part) on test report for component part(s) or
material(s) from overseas supplier;
2. IOR certifies based on test report for finished product from overseas supplier;
3. IOR certifies based on certificate for component(s) from overseas supplier; OR
4. IOR certifies based on certificate for finished product from overseas supplier
• U.S. importer still technically responsible to CPSC – must exercise “DUE
CARE” when relying on test reports or certificates from overseas suppliers

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Documents Required by U.S. Importer
1. Identification of the component/product tested

2. Lot/batch number or other “information sufficient to identify the component parts or
finished products”
3. Identification of applicable CPSC standards
4. Identification of test methods and sampling protocols used
5. Date/date range when component/product tested
6. Test reports, with test values (e.g., lead ppm reading)
7. Party who conducted test (usually 3rd party lab) and attestation by that party that
adequate test methods and sampling protocols were used
8. Component/finished product certificate (if supplier is certifying)
9. Traceability: Identification of parties ordering tests; parties conducting tests and
direct link of those tests to specific components/finished products
10. Attestation by each supplier (“certifier and testing party”) that “due care” was
exercised to ensure continued compliance while component/product was in that
company’s custody

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What is “Due Care”?
• The degree of care that a prudent and competent person engaged in the
same line of business or endeavor would exercise under similar
circumstances.
• Specifically applies to:
- Testing and certification of products generally
- Ensuring that tested components are “identical in all material respects”
to final product
- Monitoring material changes in products
- Preventing contamination/altering of tested components/materials,
including an attestation by supplier that due care was exercised while
component was in their possession
- Testing is both comprehensive and follows accepted methods

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Due Care: Paperwork, Plus What?
• “Due care does not permit willful ignorance.”
• “Generally, due care requires taking some affirmative step to ensure the
validity of the test report or certification being relied upon.”
• “Additional actions in furtherance of the due care obligation may include
asking questions about testing and sampling procedures and the third party
conformity assessment body the supplier uses, spot checking a supplier’s test
results, requesting written test procedures, or visiting a supplier’s factory or
third party laboratory.”
• “Simply reviewing the foreign manufacturer’s periodic testing plan does not
satisfy the requirement, as this approach lacks evidence that the periodic
testing plan has been implemented.”
• “Actions taken by a certifier to ensure the reliability of test reports from a
supplier may differ depending on the nature of the component part supplied,
the risk of noncompliance, the industry involved, and the nature of the
relationship with the supplier.”
Source: October 8, 2011 CPSC Staff “Response to Commissioner Anne M. Northup’s Questions Relating to Pending Proposals for
Testing and Certification and Component Parts.”

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IV. Putting it All Together: The Component
Rule &Testing and Certification Rule
Trim Component
Certification
Certification of Final
Product by Overseas
Mfr/Supplier
U.S. Importer-Retailer
Re-Certifying based
on foreign entity
certifications.

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IV. Relying on Precertified Components and Final
Product Certificates with Proper Traceability
Button A is manufactured in Asia. Garment

Garment Units
Units ## 50,001-100,000
0-50,000 using
using buttons
buttons from
from Factory
Factory A. B.
Button B is manufactured in different factory also in Asia.
Buttons are identical and indistinguishable substitute

components.
Both button manufacturers independently A A
certify the button for lead. B

B
Garment factory sources buttons from both manufacturer A and B and
applies them to the same children’s tee SKU, but documents what buttons
went on what units of shirts.
Button Factory A and B both provide Garment Factory with “Component Test Rule”
required documentation. Garment factory uses the Component Rule to rely on the
button certifications & certifies the final garment without having to retest the buttons!

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A
B
U.S. retailer imports the garment. Garment factory provides U.S. retailer
with all of the technical files for the buttons and the garment.
The retailer recertifies the tee according to the Component Testing Rule.

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A A
Lead is found in buttons offered for sale. B

Traceability Record
Traceability is tested!
Units Button Source
0-50,000 Factory A
What the CPSC does next is anyone’s guess!

55,001-100,000 Factory B

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V. Product Examples
(And Applicable CPSC Mandatory Safety Standards)

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CPSC Mandatory Standards
Applicable to Children’s Products
TABLE 1—PRODUCT SAFETY RULES APPLICABLE TO CHILDREN’S PRODUCTS

16 CFR part # (or test method or standard) Description
1420 .......................................................................................................... All-Terrain Vehicles.
1203 .......................................................................................................... Bicycle Helmets.
1512 .......................................................................................................... Bicycles.
1513 .......................................................................................................... Bunk Beds.
1500.86(a)(5) ............................................................................................ Clacker Balls.
1500.86(a)(7) and (8) ............................................................................... Dive Sticks and Other Similar Articles.
1505 .......................................................................................................... Electrically Operated Toys or Articles.
1615 .......................................................................................................... Flammability of Children’s Sleepwear, Sizes 0 through 6X.
1616 .......................................................................................................... Flammability of Children’s Sleepwear, Sizes 7 through 14.
1610 .......................................................................................................... Flammability of Clothing Textiles.

1632 .......................................................................................................... Flammability of Mattresses and Mattress Pads.
1633 .......................................................................................................... Flammability (Open Flame) of Mattress Sets.
1611 .......................................................................................................... Flammability of Vinyl Plastic Film.
1219 .......................................................................................................... Full-Size Cribs.
1215 .......................................................................................................... Infant Bath Seats.
1216 .......................................................................................................... Infant Walkers.
Sec. 101 of CPSIA (Test Method CPSC–CH–E1001–08, CPSC–CH– Lead Content in Children’s Metal Jewelry.
E1001–08.1 or 2005 CPSC Laboratory SOP).
Sec. 101 of CPSIA (Test Method CPSC–CH–E1001–08 or CPSC–CH– Lead Content in Children’s Metal Products.
E1001–08.1).
Sec. 101 of CPSIA (Test Method CPSC–CH–E1002–08 and/or CPSC– Lead Content in Children’s Non-Metal Products.
CH–E1002–08.1).
1303 .......................................................................................................... Lead Paint.
1220 .......................................................................................................... Non-Full-Size Cribs.
1511 .......................................................................................................... Pacifiers.
Sec. 108 of CPSIA (Test Method CPSC–CH–C1001–09.3 ) .................. Phthalate Content of Children’s Toys and Child Care
Articles.
1510 .......................................................................................................... Rattles.
1501 .......................................................................................................... Small Parts Rule.
1630 .......................................................................................................... Surface Flammability of Carpets and Rugs.
1631 .......................................................................................................... Surface Flammability of Small Carpets and Rugs.
1217 .......................................................................................................... Toddler Beds.
(ASTM F963) ............................................................................................ Toys.

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General Wearing Apparel Flammability
Standard: 16 CFR 1610
• Applies to most clothing and textiles (BOTH for children and adults).
• Standard does NOT apply to: most hats; gloves; footwear; or interlining
fabrics (when not an integral part of a garment). NO TESTING OR
CERTIFICATION REQUIRED for these items.
• Plain surface fabrics weighing 2.6 ounces per square yard or more are NOT
required to be TESTED for flammability (they may need to be weighed) but
DO have to be CERTIFIED.
• Any fabric, regardless of weight, made entirely from: acrylic, modacrylic,
nylon, olefin, polyester or wool likewise are NOT required to be TESTED, but
DO have to be CERTIFIED.
• Approximately 70% of apparel items are exempt from testing.

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Appendix A: Commonly Used Acronyms
GCC = General Certificate of Conformity HDOA = High Degree of Assurance

CPC = Children’s Product Certificate PTP = Periodic Testing Plan or Production Testing
Plan
COC = Certificate of Conformity
ASTM F963 = U.S. toy standard
IOR = Importer of Record
QMS = Quality Manufacturing System – such as
DM = Domestic Manufacturer
ISO9001 or other quality manufacturing certification
CPSIA = Consumer Product Safety or audit (retail or lab)
Improvement Act of 2008
ATV = All Terrain Vehicle
HR 2715 = House Resolution 2715 (CPSIA
PPM = Parts Per Million
reform legislation passed in 2011)
RTP = Reasonable Testing Program
CPSC = U.S. Consumer Product Safety
Commission

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Appendix B: Step-by-Step Approach to
Certification and Testing
Children’s Footwear
1. Identify the regulations applicable to the product
2. Comply with Undue Influence Training and Policy
3. Conduct Third Party Certification Testing
a. Only Representative samples
4. Certify the product with a Certificate of Conformity

a. Include all required information in a certificate
5. Consider Approach to Periodic Testing Plan
(Option 1, 2 or 3)
a. ISO-Accredited in-house lab? – likely not Lead Content
Metal snaps (if not an exempt material
b. Production Duration – less than one year identified by the CPSC)
total? Lead in Surface Coating (16 CFR 1303)
c. Level of supply chain engagement? Paints
[Small Parts (16 CFR 1501)]
d. Use of QMS – factory have successful [Sharp points/edges (16 CFR 1500.48/.49)]
[Tracking Labels (CPSIA Sec 103}]
quality audit?

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Appendix B: Step-by-Step Approach to
Certification and Testing
6. Create a Periodic or Production Testing Plan

a. Determine the number of samples (results) to test
for each testing intervention per regulation.
i. Evaluate what regulations use quantitative
testing (1 sample) per intervention
ii. Evaluate what regulations use qualitative
testing (multiple samples) per intervention
b. Determine the number of testing interventions per
regulation (frequency of testing)
c. Document the Plan – justify the PTP frequency, #
of samples tested, QMS and sampling plan
7. Execute the PTP and document results
Must have separate PTP for
8. Consider Material Changes each manufacturing site
9. Perform Remedial Action if necessary
10. Maintain recordkeeping requirements

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The Year of Enforcement

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CPSC Enforcement (Q1)
http://www.slideshare.net/uscpsc

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CPSC Enforcement (Q2)

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CPSC Enforcement

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CPSC Enforcement

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How is the CPSC Enforcing
• Port inspections
• In-store inspections
• Repeat offenders
• Voluntary reporting
• Mandatory reporting

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Thank You
Thank you for attending!
You will receive a PDF of the webinar presentation shortly, as

well as a link to the full audio and slides.
If you have additional questions, please contact:
Corinne Murphy
American Apparel & Footwear Association
cmurphy@wewear.org

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New CPSC Testing and

Presented by AAFA and Intertek

1 © Intertek 2012, www.intertek.com

2 © Intertek 2012, www.intertek.com

3 © Intertek 2012, www.intertek.com

4 © Intertek 2012, www.intertek.com

8/12/2011 - Signed by the President

5 © Intertek 2012, www.intertek.com

6 © Intertek 2012, www.intertek.com

H.R. 2715 tells the CPSC to:

7 © Intertek 2012, www.intertek.com

 . No Testing = No GCC χ . More preemption over states is needed

8 © Intertek 2012, www.intertek.com

• International Standards Equivalency • Determinations Regarding Synthetic

9 © Intertek 2012, www.intertek.com

• Revote on Random vs. Representative

10 © Intertek 2012, www.intertek.com

• Washington State – Children’s Safe

11 © Intertek 2012, www.intertek.com

12 © Intertek 2012, www.intertek.com

I. Basic U.S. Children’s Safety

13 © Intertek 2012, www.intertek.com

- U.S. importer/Domestic manufacturer (DM) must have a CPSC-

14 © Intertek 2012, www.intertek.com

Required (Mandatory) for Children’s Products Manufactured After

• Certificate information same as today:

16 © Intertek 2012, www.intertek.com

17 © Intertek 2012, www.intertek.com

Periodic Testing 1. Periodic 2. Production 3. In-House Production

1. Quality Management High Degree of

Frequency of 3rd Nine factors: §1107.21(b)(2)(i-ix) Production Production

Same as certification testing: Alternative methods Same as certification testing:

1. Tests conducted 1. Process mgmt techniques 1. In-house ISO-accredited

18 © Intertek 2012, www.intertek.com

• Triggered by change in:

19 © Intertek 2012, www.intertek.com

• “Undue influence” means attempting to force a lab to obtain a

20 © Intertek 2012, www.intertek.com

1. Certificates (CPCs), including product test reports

21 © Intertek 2012, www.intertek.com

• HDOA defined as “evidence-based demonstration of consistent

22 © Intertek 2012, www.intertek.com

• Rule is VOLUNTARY and mostly applies to precertification for U.S.

23 © Intertek 2012, www.intertek.com

1. Identification of the component/product tested

24 © Intertek 2012, www.intertek.com

25 © Intertek 2012, www.intertek.com

26 © Intertek 2012, www.intertek.com

27 © Intertek 2012, www.intertek.com

Button A is manufactured in Asia. Garment

Button B is manufactured in different factory also in Asia.

Buttons are identical and indistinguishable substitute

Both button manufacturers independently A A

certify the button for lead. B

28 © Intertek 2012, www.intertek.com

29 © Intertek 2012, www.intertek.com

Lead is found in buttons offered for sale. B

What the CPSC does next is anyone’s guess!

30 © Intertek 2012, www.intertek.com

31 © Intertek 2012, www.intertek.com

TABLE 1—PRODUCT SAFETY RULES APPLICABLE TO CHILDREN’S PRODUCTS

1610 .......................................................................................................... Flammability of Clothing Textiles.

32 © Intertek 2012, www.intertek.com