New CPSC Testing and Certification Requirements · New CPSC Testing and Certification Requirements...

© Intertek 2012, All Rights Reserved

www.intertek.com 1 © Intertek 2012, All Rights Reserved

New CPSC Testing and Certification Requirements

September 2012 Joseph Mohorovic, Regional SVP, Intertek Consumer Goods


Intertek’s CPSC Investments

Hal Stratton Fmr.

Chairman Intertek

since 2006

Joe Mohorovic Fmr. Chief

of Staff Intertek

since 2007

Quin Dodd Fmr. Chief

of Staff Intertek

since 2009

Gene Rider CPSC

Chairman’s Circle

Award 2011

iComply™ R&D since

2008

Andrew Farhat

Sought-after industry insider Intertek

since 2007

Unparalleled CPSC Expertise and Insight


Introduction: Topics for Training

I. Basic US Product Safety Requirements

II. Testing and Certification Rule

III. Component Part Testing Rule

IV. Putting It All Together

V. iComply™

VI. Product Examples (CPSC Mandatory Standards for Children’s Products)

Appendix A: Common Acronyms

Appendix B: Step-by-step Guide

Appendix C: Frequently Asked Questions


I. Basic US Product Safety Requirements: Overview

• The US Consumer Product Safety Commission (CPSC) oversees the safety of “consumer products” in the US (does not include food, drugs, cosmetics, vehicles or workplace products).

• Most “children’s products” (intended for children under 13 years) and some non-children’s products are subject to mandatory safety standards (e.g., lead ban, clothing flammability, etc.).

• General prohibition on selling products that pose a “substantial product hazard” (can cause injury) to consumers.

• CPSC can seek recalls and penalties for either violative (standards) or hazardous (dangerous) products.


I. Basic US Product Safety Requirements: Essential Questions

1. Are my products “children’s products” (under 13 years old)?

- Are they marketed (sold, advertised and co-located) as children’s products (e.g., advertising showing a child under 13 using the product)?

- Are they labeled as being children’s products (e.g., “For Ages 8+”)?

- Are they generally recognized as being for children (e.g., toys and children’s clothing—vs. “general use” products like non-toy sporting equipment and musical instruments)?

- Where do they fall under the CPSC Age Determination Guidelines? (http://www.cpsc.gov/BUSINFO/adg.pdf).

http://www.cpsc.gov/BUSINFO/adg.pdf



2. If I do sell “children’s products,” what standard(s) apply to them? Primary (not only)* standards for children’s products are:

- Lead in Substrate (100 parts per million for accessible—touchable-parts);

- Lead in Paint (90 ppm for paint and similar surface coatings);

- Small parts;

- ASTM F963 Mandatory Toy Standard;

- Phthalates limits (1,000 ppm for 6 specified phthalates in toys and child care articles);

- Children’s sleepwear and general wearing apparel flammability;

- Durable nursery equipment (cribs; toddler beds; etc.). * (Full list is further in this presentation).



3. What testing and certification is required for “children’s products”?

- US importer must have a CPSC-approved third party test report covering all applicable mandatory standards;

- US importer 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, US importers must also undertake certain other activities and keep certain other records OR must have their overseas supplier undertake this (CPSC Testing and Certification Rule, below);

- If the US 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 (below).



4. What testing and certification is required for “non-children’s products” (those for consumers 13+) e.g.: General Wearing Apparel Flammability; Bicycles and Bike Helmets; Lighters; Fireworks; etc?:

- Such products must comply with standards and be tested according to a “Reasonable Testing Plan;”

- For most non-children’s products, the Reasonable Testing Plan is simply what the standard itself requires (e.g., General Wearing Apparel);

- For other non-children’s product standards (e.g., walk-behind lawn mowers; pool slides; garage door openers) there are no specific requirements for what a Reasonable Testing Plan must contain. However, the Component Part Testing Rule applies to BOTH children’s and non-children’s products, so if the US importer requires the foreign manufacturer of ANY wearing apparel to certify flammability standard(s), certain documents are required for BOTH children’s AND non-children’s products! (More information about wearing apparel below).


I. Basic US Product Safety Requirements: What is Third Party Testing?

• In 2008, the Consumer Product Safety Improvement Act (CPSIA) mandated that all children’s products subject to one or more mandatory safety standards be tested by CPSC approved third party testing labs AND certified as meeting those standards.

• The law requires a third party test in order to have an objective, unbiased laboratory ensure that the product is properly tested and compliant with the law.

• Third party testing serves as the basis for a company to certify in a Children's Product Certificate (CPC) that its children's products are compliant with each applicable children's product safety rule.

• See: http://www.cpsc.gov/info/toysafety/3ptfaq.html for additional, helpful information.

• Whatever the CPSC requires, many US Retailers/Importers have their OWN, ADDITIONAL testing and certification requirements…

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

http://www.cpsc.gov/info/toysafety/3ptfaq.html


I. U.S. Importers (Especially Retailers) may Ask YOU to Comply with the Testing and Certification Rule!

RELIANCE ON OTHER TYPES OF CERTIFICATIONS

“We suggest that 16 CFR 1109 allow (importers), who exercise due care, be permitted to rely on product certifications provided by other appropriate interested parties. For example:

• For logistical purposes, multiple importers will import identical products. In many cases these are nationally branded items simply imported separately by multiple retailers for convenience. Without the ability to reference another “master” certificate, each importer/retailer would needlessly have to follow the process to independently generate its own certificate.

• Occasionally two certified products are bundled together for retail sale as a single sellable unit. As with the previous example, a retailer/importer would needlessly have to follow the process to certify the bundled product unless the retailer/importer were permitted to rely upon the certificates for each of the two bundled products.”


I. Can importers push certification responsibility upstream to foreign suppliers?

• CPSC requires that certificates of conformity be issued by the domestic manufacturer or the importer of products made outside the United States.

• This means that an importer cannot simply pass along a foreign manufacturer's certificate of conformity.

• However, the Component Part Testing Rule (16 CFR 1109), allows importers to use a foreign manufacturer's test results or their component part or finished product certifications of a children's product to issue their own Children's Product Certificate, as long as the importer exercises due care to ensure the validity of the test results or the certificate and receives the documentation required by the rule.

• See: http://www.cpsc.gov/info/toysafety/3ptfaq.html

http://www.cpsc.gov/info/toysafety/3ptfaq.html


Trim Component Certification

Certification of Final Product by Overseas

Mfr/Supplier

U.S. Importer-Retailer Re-Certifying based

on foreign entity certifications.

I. The Future of U.S. Children’s Product Certification


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.)


II. Testing and Certification Rule: 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.



II. Testing and Certification Rule: 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”


Periodic Testing Options

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 risk 3. 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

Production Testing Results

Methods Same as certification testing: CPSC approved methods only

Alternative methods allowed

Same as certification testing: CPSC approved methods only

Test plan recordkeeping

1. Tests conducted 2. 3rd Party test results 3. Testing intervals 4. # of samples tested

1. Process mgt techniques 2. Tests conducted 3. Intervals 4. # of samples 5. Basis for HDoA 6. Production Testing results 7. 3rd Party test results (if

applicable)

1. In-house ISO-accredited Production Testing results

2. 3rd Party test results (if applicable)

II. Testing And Certification Rule: Periodic vs. Production Testing


II. Testing and Certification Rule: 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


II. Testing and Certification Rule: 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).


II. Testing And Certification Rule: Samples Submitted for Testing, cont.

For Periodic/Production Testing, only “representative samples” may be submitted to ensure continued compliance

• Haphazard methods of sample selection prohibited

• Sampling procedure must be documented in the technical file

• “Rationale” or basis for sampling procedure adequacy must be documented in the technical file

• Specific information indicating production consistency can serve as basis for concluding samples submitted are representative

• Random sampling procedures allowed: (simple random sampling, cluster sampling, systematic sampling, stratified sampling, multistage sampling, etc…)


II. Testing and Certification Rule: Samples Submitted for Testing

Certification Testing: 1. Must submit sufficient number

to provide HDOA

2. Manufacturing process variability/consistency should be considered

3. Samples must be “identical in all material respects” to product sold to consumers

Periodic Testing: 1. Must submit sufficient number

to ensure continuing compliance

2. Quantitative vs. qualitative test methods

3. Must be “representative” of production population


II. Testing and Certification Rule: What Records Must Be Kept?

1. Certificates (CPCs), including product test reports

2. Periodic/Production Testing Plan (PTP)

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 US


II. Testing and Certification Rule: What is a “High Degree of Assurance”? (HDOA)

• 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.


III. Component Part Testing Rule: NOW In Effect!

• Rule is VOLUNTARY and mostly applies to precertification for US importer of record (IOR) for children’s products

• US importer may issue a certificate (CPC) based on component/final product test reports or certificates

• There are 4 options if US 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

• US importer still technically responsible to CPSC – must exercise “DUE CARE” when relying on test reports or certificates from overseas suppliers


III. Component Part Testing Rule: Documents Required by US 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 (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. 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


III. Component Part Testing Rule: 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


III. Component Part Testing Rule: 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.”


August 29, 2012: CPSC Staff PROPOSALS to Reduce Testing Costs (NOT YET IN EFFECT)

Congress directed CPSC to review ways to reduce testing costs. Recent staff proposals include: • Could consider “equivalent” international standards as meeting CPSC requirements

(e.g., EN 71 toy standard)

• Could develop/expand on lists of materials known not to contain heavy metals, including lead for toys/children’s products and for phthalates, thereby eliminating testing requirement but not compliance for those materials (e.g., certain plastic resins and “manufactured” wood materials)

• Could eliminate periodic testing requirement for fewer than 10,000 products per year and for short production runs where the certification testing provides a High Degree of Assurance

• Could create a “de minimus” exemption from lead testing for very small areas of paint on children’s products

HOWEVER, any of these changes will take time and may not occur before the Feb 8, 2013 effective date of the Testing and Certification Rule!

http://www.cpsc.gov/library/foia/foia12/brief/reduce3pt.pdf


Trim Component Certification

Certification of Final Product by Overseas

Mfr/Supplier

U.S. Importer-Retailer Re-Certifying based

on foreign entity certifications.

IV. Putting it All Together


IV. Putting It All Together: Traceability Example 1

B A A

Button A is manufactured in Asia.

Button B is manufactured in different factory also in Asia.

Buttons are identical and indistinguishable substitute components.

Both button manufacturers independently certify the button for lead.

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!

B

Garment Units # 0-50,000 using buttons from Factory A.

Garment Units # 50,001-100,000 using buttons from Factory B.



B A 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.



B A Lead is found in buttons offered for sale.

Traceability is tested!

What the CPSC does next is anyone’s guess!

Traceability Record

Units Button Source

0-50,000

55,001-100,000

Factory A

Factory B

A



B A A

Button A is manufactured in Asia.

Button B is manufactured in different factory also in Asia.

Buttons are not identical. They are distinguishable by color.

Both button manufacturers independently certify the button for lead.

Garment factory sources buttons from both manufacturer A and B and applies them to the same children’s tee SKU. Garment factory does not include traceability records for the buttons because the source is obvious by color. Garment factory uses the Component Rule to rely on the button certifications & certifies the final garment without having to retest the buttons for lead.

B



B A U.S. retailer imports the garment.

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



B A Lead is found in buttons offered for sale.

Traceability is tested! But since the button source is obvious, the Garment manufacture and the U.S. retailer can both identify that the violative button was sourced from Factory A.

A

What the CPSC does next is anyone’s guess!


Patent Pending. iComplyTM is a trademark of Intertek Testing Services NA Inc. Information in this presentation is subject to change without notice

V. iComply™ Simple Solution. Sophisticated Technology.

January 2012 36


Western Market Technical File Requirements for Children’s Products

CPSC Component Parts Rule


The iComply™ Solution Enabling Collaborative Technical File Assembly

A web-based, artificial intelligence application facilitating collaborative supply chain assembly of technical files required in multiple jurisdictions (EU, US & Canada):

• CAPTURE compliance documentation across multiple products and manufacturers

• CREATE a Production Testing Plan (PTP) referencing test requirements, frequency and number of results required per intervention satisfying both periodic and production testing

• GENERATE a Certificate of Conformity

• MANAGE compliance without increasing quality assurance staff or overhead costs

• TRACK material change, remedial actions and policies to prohibit “Undue Influence” across the supply chain

Through iComply™, you can demonstrate a “High Degree of Assurance” that your products comply with mandatory regulations.


The iComply™ Solution Enabling Collaborative Technical File Assembly – The Process

Material Change

*Undue Influence Training &

Record Keeping

Product Technical File

* For compliance to US CPSC Testing and Certification Rule

Presenter

Presentation Notes

There are only a few simple steps to compile a technical for a product in iComply: [click] The process starts with Product Setup where you enter product information. [click] Then enter production information [click] Based on the information provide, the system will automatically generate a Production Testing Plan (PTP) and a Product Specification. [click] After the product has been tested, related test reports may be uploaded. At your discretion, service provider may also upload test reports for you. [click] Once the certification test is completed, you can generate a Certificate of Compliance such as General Certificate of Compliance (GCC) or Children’s Product Certificate (CPC). [click] All the documents generated or uploaded will be captured in the technical file. Now I will take you through the process in details by adding a new product.


Brand, Retailer or Importer

Finished Product Factory

Raw Material, Component or Subassembly

Supplier

Retailers

Retailers can have

visibility at different Supply Chain levels

Raw material and component suppliers can certify material

and have compliance documentation (technical file)

in iComply™

U.S. importers must have technical files for children’s

products. In iComply™, Retailers can demonstrate

compliance with Testing and Certification Rule.

Supply Chain Collaboration, Transparency and Compliance

Finished Product manufacturers can construct technical files and

upload verifications/reports


iComply™ Scope Product categories currently covered in iComply™

* = Includes most state regulations and California Proposition 65



VI. Product Examples

(And Applicable CPSC Mandatory Safety Standards)


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.


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.


Adult Apparel • If not exempt from testing (due to weight or fabric type),

must be tested and certified to general wearing apparel flammability standard. (But need NOT use a CPSC-approved third party testing lab, unless US importer requires).

• Following the prescribed test procedures in 16 CFR 1610 is a per se Reasonable Testing Plan. However, you may want to undertake a more rigorous testing program, as will be required in February 2013 for children’s products.

• Likely no other CPSC standards apply to such products.



Children’s Apparel

Federal Flammability of apparel: 16 CFR 1610/1611 Lead content: CPSIA Section 101(a)(2) Lead in paint & similar surface coatings: 16

CFR 1303 Small parts

1: 16 CFR 1501

Sharp edge and sharp points: 16 CFR 1500.48/1500.49 Drawstring requirements: 16 CFR 1120 Tracking labels: CPSIA Section 103 Children’s Product Certificate: 16 CFR 1110

1. Apparel exempt by 16 CFR1501 but compliance generally required




Federal Fiber labeling: 16 CFR 300/303 Care labeling: 16 CFR 423 Country of Origin: 19 CFR 134

State Drawstrings: State of New York and Wisconsin Illinois Lead Poison Prevention Act Proposition 65 settlements for lead and phthalates WA – CSPA Reporting Rule

1

Toxins in packaging (for any disposable packaging) Suffocation warning label for plastic bag (if applicable)

1. Reporting deadline based on size of the company.



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

* Non-exempt general wearing 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!



Children’s Shoes

Federal Lead content: CPSIA Section

101(a)(2) Lead in paint & similar surface

coatings: 16 CFR 1303 Tracking labels: CPSIA Section 103 Small parts

1: 16 CFR 1501

Sharp edge and sharp points: 16 CFR 1500.48/1500.49 Children’s Product Certificate: 16

CFR 1110 Country of Origin: 19 CFR 134

1. Footwear exempt by 16 CFR 1501 but compliance required



State Illinois Lead Poison Prevention Act Proposition 65 settlements for lead and

phthalates WA – CSPA Reporting Rule

Toxins in packaging (for any disposable packaging) Suffocation warning label for plastic bag

(if applicable)


Children’s Shoes



Children’s Toy

Federal Toy safety standard – ASTM F963-11 Soluble Heavy metals for surface coatings

and substrates – ASTM F963-11 Sec 4.3.5 Lead content: CPSIA Section 101(a)(2) Lead in paint & similar surface coatings: 16

CFR 1303 Phthalate content: CPSIA Section 108 Small parts: 16 CFR 1501 Sharp edge and sharp points: 16 CFR

1500.48/1500.49 Tracking labels: CPSIA Section 103



Children’s Toy

Federal Children’s Product Certificate: 16 CFR

1110 Country of Origin: 19 CFR 134

State Illinois Lead Poison Prevention Act WA – CSPA Reporting Rule

1

Toxins in packaging (for any disposable packaging) Suffocation warning label for plastic

bag (if applicable)




Children’s Electronic Products

Federal1

Toy safety standard – ASTM F963-11 Soluble Heavy metals for surface coatings and substrates – ASTM F963-11

Sec 4.3.5 Lead content: CPSIA Section 101(a)(2)

2

Lead in paint & similar surface coatings: 16 CFR 1303 Phthalate content: CPSIA Section 108 Sharp edge and sharp points: 16 CFR 1500.48/1500.49 Tracking labels: CPSIA Section 103

1. Additional FCC and other Federal requirements may apply. 2. Under 16 CFR 1500.88, CPSC has provided exemptions and higher limit for certain electronic devices.



Federal Children’s Product Certificate: 16 CFR 1110 Country of Origin: 19 CFR 134


1

Toxins in packaging (for any disposable packaging) Suffocation warning label for plastic bag (if applicable)


Children’s Electronic Products



Sippy Cup

Federal Lead content: CPSIA Section 101(a)(2) Lead in paint & similar surface coatings:

16 CFR 1303 Phthalate content: CPSIA Section 108 Small parts: 16 CFR 1501 Sharp edge and sharp points: 16 CFR

1500.48/1500.49 Tracking labels: CPSIA Section 103 Children’s Product Certificate: 16 CFR




Sippy Cup

Federal FDA Food contact article requirements

(21 CFR 175-177 based on materials)


1

Bisphenol-A ban Toxins in packaging (for any disposable

packaging) Suffocation warning label for plastic

bag (if applicable)




Children’s Bicycle

Federal Requirements for bicycles: 16 CFR 1512 Lead content: CPSIA Section 101(a)(2) Lead in paint & similar surface coatings:

16 CFR 1303 Tracking labels: CPSIA Section 103 Sharp edge and sharp points: 16 CFR

1500.48/1500.49 Children’s Product Certificate: 16 CFR


1. Certain metal components have 300 ppm limit and do not require 3rd

party testing due to HR2715 CPSIA amendment



State Law labels for stuffed seats “Wear a helmet” hang tag– New

Jersey Code 13:45A – 24.4 Proposition 65 settlements for

lead and cadmium Toxins in packaging requirement

(for any disposable packaging) Suffocation warning label for

plastic bag (if applicable)

Children’s Bicycle



Durable Nursery Products

Section 104 of the Consumer Product Safety Improvement Act (CPSIA) requires the CPSC to develop new safety standards for infant and toddler products: Includes: full-size and non-full-size

cribs, toddler beds, high chairs, booster chairs, hook on chairs, bath seats, gates, play yards, stationary activity centers, infant carriers, strollers, walkers, swings, and bassinets/cradles

CPSC is scheduled to promulgate two new safety standards every six months

Presenter

Presentation Notes

In actuality, is closer to two new safety rules every nine to twelve months



Existing DNP Specific Regulations

Name Effective Date

Name Effective Date

16 CFR 1215 Infant Bath Seats

12/6/2010 16 CFR 1216 Infant Walkers

12/21/2010

16 CFR 1219 Full Size Cribs

6/28/2011* 16 CFR 1220 Non Full Size Cribs

6/28/2011*

16 CFR 1217 Toddler Beds

10/20/2011

16 CFR 1224 Portable Bed Rails

8/29/2012

16 CFR 1221 Play Yards

2/28/2013

Presenter

Presentation Notes

The final rule for 16 CFR 1221 was just recently published to the federal register – put out August 30th, 2012



Tentative Schedule for DNP Rulemaking

Name Rulemaking Status Name Rulemaking Status

16 CFR 1223 Infant Swings

Final Rule: September 2012

16 CFR 1218 Bassinets and Cradles

Notice of Proposed Rulemaking: Q4 2012

Soft Infant Carriers Notice of Proposed Rulemaking: Q4 2012

Hand Held Infant Carriers

Notice of Proposed Rulemaking: Q4 2012

Strollers and Carriages Notice of Proposed Rulemaking: Q4 2012

Infant Inclined Sleep Products

Notice of Proposed Rulemaking: 2013

Bedside Sleepers Notice of Proposed Rulemaking: 2013

Infant Bouncers Notice of Proposed Rulemaking: 2013

High Chairs Notice of Proposed Rulemaking: 2013

Framed Infant Carriers Notice of Proposed Rulemaking: 2013

Infant Slings Notice of Proposed Rulemaking: 2013



Federal Product specific regulation: e.g. 16

CFR 1219 Lead content: CPSIA Section 101(a)(2) Lead content in paints and surface

coatings: 16 CFR 1303 Small parts: 16 CFR 1501 Sharp points and sharp edges: 16 CFR

1500.48/49 Phthalate content (if for sleep): CPSIA

Section 108




Federal Tracking labels: CPSIA Section 103 Product registration card : CPSIA

Section 104 Children’s Product Certificate: 16 CFR


State Illinois Lead Poison Prevention Act WA – CSPA Reporting Rule Toxins in packaging requirement (for any

disposable packaging) Suffocation warning label for plastic bag

(if applicable)



Appendix A: 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 Improvement 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


Appendix B: Step-by-Step Approach to Certification and Testing

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

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 Content Metal snaps (if not an exempt material identified by the CPSC)

Lead in Surface Coating (16 CFR 1303) Paints

Phthalates Paints

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



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



1. Identify the regulations applicable to the product

2. Comply with Undue Influence Training and Policy

3. Conduct Third Party Certification Testing a. Only samples materially identical

4. Certify the product with a COC

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?

Must have separate PTP for each

manufacturing site

Simple Toy Train


Appendix B: Step-by-Step Approach, cont.

Lead Content Metal (if not an exempt material identified by the CPSC)

Lead in Surface Coating (16 CFR 1303) Paints

Phthalates Paints

ASTM F963 Magnets: flux, abuse for release Soluble HM paint Small Parts (16 CFR 1501) Flammability (16 CFR 1500.44) Sharp points/edges (16 CFR 1500.48/.49)

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


Appendix C: Frequently Asked Questions

Q: If my US customer (importer) asks for a certificate (CPC) for the children’s products I sell them, what must I do?

A: First, you must have the children’s product tested by a CPSC-listed (approved) lab (http://www.cpsc.gov/cgi-bin/labsearch/). Next, you must issue a certificate (CPC) for that product (http://www.cpsc.gov/businfo/cpc.html). In addition, YOU must adhere to the requirements of the CPSC Testing and Certification Rule. Finally, the US Importer must adhere to the requirements of the Component Part Testing Rule.

Q: Does the certification requirement apply to only children’s products:

A: No. A certificate must be issued for all products, including non-children’s products, that are covered by one or more US product safety standards. However, only children’s products are required to be tested by CPSC-approved third party labs and beginning on February 8, 2013, will be subject to the requirements of the CPSC Testing and Certification Rule.

Q: If the US importer receives from me a valid CPC with the children’s product I send to it, what else must that importer do?

A: The US importer must itself issue a CPC for that children’s product, based on the certificate it receives from you, in accordance with the requirements of the CPSC Component Part Testing Rule.

http://www.cpsc.gov/cgi-bin/labsearch/



Appendix C: Frequently Asked Questions, cont.

Q: Who is potentially in trouble with the CPSC if there is found to be a violation of CPSC standard with a product I sell to a US importer?

A: If a product is found to be in violation of a CPSC standard OR is found to be dangerous to consumers, the CPSC may request that EITHER YOU as the foreign manufacturer OR the US importer conduct a recall of the product or otherwise fix the problem with the product. It MAY also seek to fine (a monetary penalty) from either YOU as the foreign manufacturer OR from the US importer, distributor or retailer of the product.

Q: If I issue a CPC for my US customer/importer, what must that importer do to exercise “due care” that I complied with the requirements of the Testing and Certification Rule?

A: That depends on a number of factors, notably including the level of trust and confidence the US importer has in you as the foreign manufacturer. If there is a long-established relationship and no history of problems with CPSC safety standards and other requirements, the CPSC will expect the US importer to exercise less diligence than if there is not such an established relationship. Essentially, the CPSC will expect the US importer to exercise the degree of prudence (“care”) that a similarly situated importer would exercise under similar circumstances.


Appendix C: Frequently Asked Questions, cont.

Q: Where can I find model undue influence training/policies?

A: The CPSC has not provided any. iComply™ and possibly other sources suggest model policies and brief employee training.

Q: If I issue a CPC for my us customer/importer, does that importer need to supply the CPC with its other Customs (CBP) documents required for import?

A: No. The importer must only provide a previously created CPC to the CPSC or CBP upon request by either agency.

Q: What are the penalties for failure to comply with any of these new rules?

A: Violating these rules is a “prohibited act,” and can subject either the foreign manufacturer or the US importer, distributor or retailer to civil penalties and other enforcement actions by the CPSC. But keep in mind that issues regarding failure to comply with the new Testing and Certification or Component Part Testing rules will most likely arise in the event of a non- compliant product (a product that fails to meet one or more CPSC mandatory safety standards).


Thank You for Attending Our Training!

QUESTIONS?

Joseph Mohorovic Intertek Consumer Goods North America [email protected]

mailto:[email protected]


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