2012 Safety Academy: Testing and Certification

Panel on Testing-2012Safety Academy•

Mr. Randy Butturini CPSC Office of Hazard Identification &

Reduction

Ms. Mary House CPSC Office of General Counsel

Mr. Quin Dodd Quin Dodd LLC

U.S. Consumer Product Safety Commission

This presentation was prepared by CPSC staff, has not been reviewed or approved by, and may not reflect the views of, the Commission.

The Basics of Required Consumer Product Testing and Certification

Randy Butturini Mary House EXHR OGC

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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.

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CPSC Testing & Certification Requirements

No testing or certification is required for

products that are not subject to a consumer product safety rule.

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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.

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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.

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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.

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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.

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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

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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.

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4. Collect test reports and other information in a certificate.

5. “Enter into Commerce.”

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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

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.

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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.

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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.

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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.

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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.

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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)

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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.

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Raincoat

4. Collect test reports and other information in a CPC.

5. “Enter into Commerce.”

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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.)

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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


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.)

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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.

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How Can I Use Component Part Testing?

Component Part Testing

non-children’s products children’s products

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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.

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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).

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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)).

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What Certification Requirements Exist for Regulated Products?

General Conformity Certificates (GCCs) – non-children’s products

Children’s Product Certificates (CPCs) – children’s products

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Certificates must be issued by:•Importer - products made outside the U.S.; or•Domestic manufacturer - products made in the U.S.

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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.

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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


For Examples and Additional Information

on GCCs: http://www.cpsc.gov/BUSINFO/gcc.html

on CPCs: http://www.cpsc.gov/businfo/cpc.html

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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

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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.

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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.

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Further Information

CPSIA:

http://www.cpsc.gov/about/cpsia/cpsia.html

Small Business Ombudsman:

http://www.cpsc.gov/businfo/smbus.html

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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, [email protected]

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.

3. Sample failure response (remedial actions undertaken)4. “Material changes” and responses thereto (probably requires a

product specification—list of components, materials, etc.)5. Undue Influence policies and training docs6. If no Periodic/Production Test Plan, otherwise document HDOA7. 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).

Law Offices ofQuin 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 standards3. Identification of test methods and sampling protocols used4. Date/date range when component/product tested5. 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


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.


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).


Checklist to Reduce Testing Costs:

• 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?


Consumer Product Safety Commission

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Mr. Dean W. Woodard U.S. CPSC Director Office of Education, Global Outreach, and

Small Business Ombudsman

[email protected] [email protected]

mailto:[email protected]

mailto:[email protected]

2012 Safety Academy: Testing and Certification

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