Cpsia

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New CPSC Testing and Certification Requirements

January 2012Quin Dodd, Law Offices of Quin D. DoddJoseph Mohorovic, Regional SVP, Intertek Consumer GoodsMichael McDonald, AAFA Government Relations Representative


Introduction: Topics for Training

1. CPSIA Refresh

2. CPSIA Reform Legislation

3. Certification

4. Component Testing Rule

5. Certification and Testing Rule

6. Putting It All Together

7. Apparel Scenarios

8. Practical Tips

9. How to Certify a Children’s Product

10.Questions & Answers


Commonly Used Acronyms

GCC = General Certificate of Conformity

CPC = Children’s Product Certificate

COC = Certificate of Conformity

IOR = Importer of Record

DM = Domestic Manufacturer

CPSIA = Consumer Product Safety Act of 2008

HR 2715 = House Resolution 2715 (CPSIA reform legislation passed in 2011)

CPSC = U.S. Consumer Product Safety Commission

HDoA = High Degree of Assurance

PTP = Periodic Testing Plan or Production Testing Plan

ASTM F963 = U.S. toy standard

QMS = Quality Manufacturing System – such as ISO9001 or other quality manufacturing certification or audit (retail or lab)

ATV = All Terrain Vehicle

PPM = Parts Per Million

RTP = Reasonable Testing Program


CPSIA Review: Refresher Course

• CPSIA Enacted Aug 2008

• New standards for lead in substrate (now 100 ppm); phthalates; toys; durable nursery products; and ATVs

- Note growing issue of phthalates in paints and other surface coatings!

• Certification (GCC/CPC/COC) for all mandatory CPSC standards

• Third party testing and cert for “children’s products” to mandatory CPSC standards

• Established CPSC Public Database

• Tracking labels for children’s products and warning labels on toy and game advertising

• Various enhanced enforcement authorities

• Testing and Certification rulemaking required


HR 2715: Congress CPSIA Reform

• Enacted Aug 2011

• Makes 100 ppm prospective and allows for possible “functional purpose” lead exemptions

• Exempts inaccessible parts from phthalates limits

• Exempts most used children’s products and youth ATVs (entirely) from lead substrate; and establishes 300 ppm and no third party testing for metal parts of youth bikes and jogger strollers

• Third party testing exemption for “small batch manufacturers” (fewer than 7500 units and $1 million in previous year’s consumer products revenues); and ordinary books for kids 4-12

• Minor modifications to Database procedures

• Allows Commission to grant exclusions from tracking label mandate

• Requires Commission to review of third party testing costs (comment period now open)


Testing and Certification:Expiration of All Previous “Stays”

• Certification required of IORs and DMs for products subject to mandatory CPSC standards

• “Stays of enforcement” have been lifting; “big three” (lead substrate; phthalates and mandatory toy standard) lift for products manufactured after Jan 1, 2012

• CPSIA mandated agency issue specific third party testing and certification requirements for children’s products

• “Reasonable Testing Plan” for non-children’s (“general use”) products remains (and remains undefined, so far)

• October 19, 2011 Commission approved mandatory Testing and Certification; Representative Samples; and “Labeling” Rules; all become effective for products manufactured after Feb 8, 2013

• Component Part Testing became effective December 8, 2011 (voluntary, not mandatory rule)


Component Testing Rule: Allows for VoluntaryPrecertification for Lead and Phthalates

• Effective now, but references to compliance with Testing and Certification Rule (“part 1107”) not yet effective (until Feb 8, 2013).

• Mostly applies to lead (paint and substrate) and phthalates

• IOR/DM may issue a certificate based on component/final product test reports or certificates

• So 4 options IF you choose to utilize this rule:1. IOR/DM certifies based (in whole or in part) on test report for

component part(s) or material(s);

2. IOR/DM certifies based on test report for finished product;

3. IOR/DM certifies based on certificate for component(s);

4. IOR/DM certifies based on certificate for finished product

• Importer/DM still technically “on the hook” with CPSC---must exercise “DUE CARE”—more than just checking boxes--“the degree of care that a prudent and competent person engaged in the same line of business or endeavor would exercise under similar circumstances…does not permit willful ignorance”

• Major retailers may choose to continue allowing only finished product testing to support certification


Documentation Required for CPC Based on Component Test Report or CPC

• Extensive documentation required in order for IOR/DM to certify based on other’s (component) testing; 10 elements required: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 (usu. 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. 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


Certification and Testing Rule:High Degree of Recordkeeping

(Applies Only to Children’s Products and MAY Change After CPSC Review)4 Key Elements:

1. Certification testing

2. Periodic Testing/Production Testing Plan

3. Material Change requires retesting

4. Undue Influence policies and training

• Required for Children’s Products manufactured after February, 2013.

• All above must provide certifier with High Degree of Assurance of compliance with standards

• HDOA defined as “evidence-based demonstration of consistent performance of a product regarding compliance based on actual knowledge of product and manufacturing process”


Testing and Certification Rule:Certification

• Required of IORs and DMs

• Certificate information same as today: http://www.cpsc.gov/about/cpsia/faq/elecertfaq.pdf

• Title of certificates not important: GCC, CPC or COC

• For children’s products, certification must be based on CPSC-approved third party 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”

• A single sample failure requires investigation and possible remedial action which could include recertification—must restore HDOA


Testing and Certification Rule: Periodic/Production Testing

Periodic Testing is required to ensure continued product compliance after certification testing. Three options allowed to satisfy Periodic Testing1. Default is annual third party retesting during production

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)

3. Third Party Testing every three years if also doing in-house ISO-certified lab testing

• Requires a document entitled “Periodic (or Production) Testing Plan,” which must contain explanation and justification (at each factory) for:- Testing interval

- Tests to be conducted

- Number of samples and selection method

- If using Production Testing Plan, the “productionmanagement techniques” used plus “some testing”

• Remember all elements go to HDOA, note especially manufacturing process variability (types of manufacturing processes can greatly affect likelihood of standards violations)


Periodic TestingOptions

1. Periodic Testing

2. Production Testing

3. In-House Production Testing by ISO-Accredited Lab

Frequency of in-house testing based on:

None 1. Quality Management System Use

2. Product risk3. Manufacturing process

variability

High Degree of Assurance (HDoA) of

continued product compliance

Frequency of 3rd Party Periodic Testing:

At least annual None or every 2 years None or every 3 years

Frequency of 3rd

Party Testing based on:

Nine factors: §1107.21(b)(2)(i-ix)• Test result variability• Results close to limit• Mfr process factors• Consumer complaints• Injury potential• High volume• Visually undetectable

noncompliance

Production Testing Results

ProductionTesting Results

Methods Same as certification testing: CPSC approved methods only

Alternative methodsallowed

Same as certification testing: CPSC approved methods only

Test planrecordkeeping

1. Tests conducted2. 3rd Party test results3. Testing intervals4. # of samples tested

1. Process mgt techniques2. Tests conducted3. Intervals4. # of samples5. Basis for HDoA6. Production Testing results7. 3rd Party test results (if

applicable)

1. In-house ISO-accredited Production Testing results

2. 3rd Party test results (if applicable)

Choosing a Periodic Testing Approachfor Certifying Children’s Products


Testing and Certification Rule: Material Change

• Triggered by change in:

1) design;

2) manufacturing process; or

3) suppliers

• Material Change is something that might impact compliance

• Requires new third party testing and recertification (but only for rules potentially impacted by change)

• Effectively requires a Product Specification/Bill of Materials


Testing and Certification Rule: Undue Influence

• Must maintain written policy against (and have other “safeguards”)

• “Appropriate staff” must be trained and attest to 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.


Testing and Certification: Record Keeping

• Certificates

• PTP (Periodic or Production) including test results and basis for concluding that the PTP achieves a “HDOA” of continued product compliance.

• Sample failure response (including Product Specification)

• Material Changes and responses thereto

• Undue Influence policies and training

• Requires records be kept for 5 years and provided (and translated if necessary) to CPSC within 48 hours of request

• Don’t need to be initially in English. (May want your factory’s PTP to be in local language to ensure it’s employed).


Very Interesting, But What Do I Have to Do?!?

• If you’re not the IOR or DM, nothing (unless your retail customer/vendor/agent wants you to certify)

• If you’re the IOR/DM you must issue certificates for products covered by mandatory standards (including “Big Three” on Jan 1, 2012)

• If you’re the IOR/DM, you can begin relying on component part supplier test reports/certificates to issue your certificate, but you need required documentation

• Beginning February 2013 IOR/DM will have to follow Testing and Certification Rules OR your certifying supplier (factory/agent/vendor) will have to follow


Trim Component Certification

Certification of Final Product by Overseas

Mfr/Supplier

U.S. Importer-Retailer Re-Certifying based

on foreign entity certifications.

Putting it All Together:


Button is manufactured in Asia.

Button manufacturer certifies the button for lead.

Garment factory uses the button on a children’s tee.

Garment factory uses the Component Rule to rely on the button certification & certify the final garment.

Phase 1


U.S. retailer imports the garment.

The retailer recertifies the tee according to the Component Testing Rule.

Phase 2


Lead is found in buttons offered for sale.

Traceability is tested!

What the CPSC does next is anyone’s guess!

Phase 3


Practical Tips: Hitting the Compliance Sweet Spot

• Differentiate between “children’s” and “general use” products and treat them differently

• Use the right formula for risk-based periodic/production testing frequency.

• Don’t over test

• Before relying on others’ certifications, determine if you really trust them.

• Production Testing likely the most cost-effective alternative.


Practical Tips: Avoid the Port-of-Entry “Gotchas”

• While not required, good idea to include certificates with other import forms

• Incorrectly classified imports/obvious IP violations two big sources of inspections

• Lead paint and small parts still two biggest sources of holds/seizures at US Ports

• Consider participation in CPSC/CBP Importer Self-Assessment Program

• If relying on foreign supplier’s certificate, ensure you have the required documentation [§1109.5(g)], and

• Remember that CPSC defines “Due Care” obligation as “receive, review and ensure” appropriateness of documentation for component certification reliance


Apparel Summary

Must issue certificate for flammability for non-children’s, non-exempt wearing apparel

For children’s wearing apparel, must issue certificate (based on third party testing) for:

* Non-exempt generalwearing apparel

flammability* Lead paint

* Lead substrate * Phthalates

* Children’s sleepwear flammability

• Feb 2013, Testing and Certification requirements/documentation required• Final product certificate based on components are OK: Warning: traceability required!


How to Certify a Children’s Product for Compliance According to the New Testing and Certification Rules

1. Identify the regulations applicable to the product

2. Comply with Undue Influence Training and Policy

3. Conduct Third Party Certification Testinga. 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

b. Production Duration – less than one year total?

c. Level of supply chain engagement?

d. Use of QMS – factory have successful quality audit?

Children’s Sleepwear

Lead ContentMetal snaps (if not an exempt material identified by the CPSC)

Lead in Surface Coating (16 CFR 1303)Paints

PhthalatesPaints

Flammability (16 CFR 1615/1616)[Small Parts (16 CFR 1501)][Sharp points/edges (16 CFR 1500.48/.49)]


How to Certify a Children’s Product for Compliance According to the New Testing and Certification Rules

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

8. Consider Material Changes

9. Perform Remedial Action if necessary

10. Maintain recordkeeping requirements

Must have separate PTP for each

manufacturing site


What Comes Next?

January 23rd comments

• Reducing Third Party Testing Burdens

• Random vs. Representative Testing

February 1st

• AAFA Product Safety Seminar (NY,NY)

February 8th 2013

• Periodic Testing Rule goes into full effect


Comments for the CPSC

• Make clear in that no certification is required when testing is not required

• Provide small batch exemptions for large manufactures producing a small batch.

• Fix the determination on inaccessibility and fabric barriers• Fix the boundaries of lead in fabric determination (prints,

screen prints, etc.) • Define child care articles to NOT include kids pajamas • Revisit whether general product safety rules (FFA) are

considered children product safety rules. • More aggressive use of CPSC preemption to ensure better

alignment among different regulatory regimes • Build into the 100ppm limit a de minimis or other factor to

accommodate interlab variability. • We need more ideas from industry so send me your ideas.

- [email protected]


How to Stay Informed

• Sign up for emails from the CPSC

• Get the AAFA RSL

• Register for the AAFA Product Safety Seminar– On February 1st at FIT in New York

• Join AAFA– Sign up for AAFA News Breaker– Join the Product Safety Council (PSC)

• Work with your testing lab

• Call Me (703)797-9052


Thank You for Attending Our Webinar

For further questions regarding the content of this webinar, please direct them to our respective experts designated

below. Thank you and have a great day!

Quin DoddLaw Offices of Quin D. Dodd, [email protected]

Joseph MohorovicIntertek Consumer Goods North [email protected]

Michael McDonaldAmerican Apparel & Footwear [email protected]

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