What Businesses Need to Know About Product Safety in North America: Regulations, Recalls, and Best Practices for Children’s Products

What Businesses Need to Know About Product Safety in North America:

Regulations, Recalls, and Best Practices for Children’s Products

Note: Presentation Available for Download: www.slideshare.net/USCPSC

VIEWS EXPRESSED IN THIS PRESENTATION ARE THOSE OF THE STAFF AND DO NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION, HEALTH CANADA, OR PROFECO.

Today’s Presentation

• Provide an overview of consumer product safety legislation and authorities in the three jurisdictions

• Highlight similarities and differences in requirements for industry, using strollers as a case study

• Outline the benefits of joint recalls to encourage industry to engage with the North American Regulators simultaneously

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Health Canada

United States Consumer Product Safety Commission

Mexico

MISSION STATEMENTSPRODUCT SAFETY: NORTH AMERICA

The mission of Health Canada (HC)’s Consumer Product Safety Program is to identify, assess, manage and communicate health or safety risks to Canadians, associated with consumer products and cosmetics.

Protecting the public against unreasonable risks of injury from consumer products through education, safety standards activities, regulation, and enforcement.

Protect and promote the rights of consumers, ensuring fair trade relationships that strengthen the culture of responsible consumption and access to better market products and services, ensuring certainty, legality and legal security within the normative framework of human rights recognized for the consumer.

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IMPORTANCE OF NORTH AMERICAN MARKETSPRODUCT SAFETY: NORTH AMERICA

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The North American Free Trade Agreement has led to integrated markets and enhanced trade among Canada, United States, and Mexico.

In 2012, Canada imported over $68 billion (USD) worth of consumer products from the United States and $6 billion (USD) from Mexico. • $960 million (USD) in Toys from the United States. • $146 million (USD) in Toys from Mexico.

The United States imported more than $81 billion (USD) worth of consumer products from the Mexico in 2012 and over $38 billion (USD) from Canada:

• The United States imported $605 million (USD) worth of Toys, Games, & Children’s Vehicles from Mexico in 2012.

• The United States imported $200 million (USD) worth of Toys, Games, & Children’s Vehicles from Canada in 2012.

• Mexico imports $199 million (USD) in Toys from United States of America.• Mexico imports $18 million (USD) in Toys from Canada.

(Sources: OECD, CPSC, INEGI. Due to different sources & product coding, figures may not correlate exactly.)

WHAT ARE WE TRYING TO ACCOMPLISH? PRODUCT SAFETY: NORTH AMERICA

Increasing integration of the North American market is driving greater cooperation among consumer product safety regulators.

All three countries are working to:

• Enhance and maintain ongoing communication, cooperation, and information exchange between North American regulators, including consultations on proposed regulations and voluntary standards.

• Increase cooperation on product recalls.• Enhance cooperation on industry training and outreach within North

America.

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Consumer Product Safety Legislation in North America

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KEY LEGISLATION

Canada Consumer Product Safety Act (CCPSA)• Addresses or prevents dangers to human health or safety that are

posed by consumer products in Canada, including those that circulate within Canada and those that are imported. • “General Prohibition” against the supply of consumer products that pose a

danger to human health or safety

• Onus is on suppliers to ensure products they bring to market comply with the Act and regulations:

• Establishes responsibilities for manufacturers, importers, advertisers, and retailers of consumer products, including:

• Mandatory Incident Reporting; • Record-keeping to allow traceability of products within the distribution

chain7

KEY POWERS AVAILABLE TO HC

• Seize product, documents or materials• Require tests and studies necessary to verify

compliance or prevent non-compliance • Order suppliers to carry out recalls and to take other

corrective actions • Fines and Administrative monetary penalties scheme

(AMPS)• Disclose personal or business information necessary to

identify or address a serious danger to human health or safety

• Issue public communications8

KEY LEGISLATION

Consumer Product Safety Act (CPSA)• Manufacturers and importers must third party test and certify

children’s products to ensure products they bring to market comply with the Act and regulations.

• Industry self-reporting through Section 15.

Federal Hazardous Substances Act (FHSA)• Requires precautionary labeling on the immediate container of

hazardous household products to help consumers safely store and use those products and to give them information about immediate first aid steps to take if an accident happens.

• Bans certain products that are so dangerous or the nature of the hazard is such that the labeling the act requires is not adequate to protect consumers. 9

KEY POWERS AVAILABLE TO CPSC

• Order a manufacturer to cease distribution, repair, replace, or refund the purchase price of a product

• Seize and destroy product at the port of entry• Issue public communications and warnings re: a

product and a recall/corrective action plan• Investigate for civil and criminal penalties for failure to

report in a timely and adequate manner; other violations

• Injunctive relief• Above can be via court or administrative proceedings or

voluntary, in cooperation with the manufacturer.10

KEY LEGISLATIONFEDERAL CONSUMER PROTECTION LAW

Federal Law on Metrology and StandardizationFederal Law for Public ServiceCustoms Law

• Onus on suppliers to ensure products they bring to market comply with the Act and regulations.

• Modern tools to strengthen protection of human health and safety: • regulates the manufacture, import, sale and advertisement of all consumer

products. • expands the definition of “consumer product”:

• including its components, parts or accessories, • reasonably be expected to be obtained by an individual to be used for

non-commercial purposes, • domestic, recreational and sports products • includes its packaging.

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KEY POWERS AVAILABLE TO PROFECO

• Seize product, documents or materials• Order corrective measures (e.g. stop importation)

• Order recall• Carry out recalls and/or corrective measures (on behalf

of company)• Issue Notices of Violation (AMPs)• Issue public communications• Investigation for prosecution• Apply for Injunction – by authority of Magistrate

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Regulations, Best Practices, and Recalls for Children’s Products

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Most frequently notified products (Summarized)

35.3

10.5

16.0

7.8

34.9

10.3 9.510.7

34.6

9.0

12.1

9.6

0.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

40.0

Children Products Electrical appliances Motor vehicles Adult clothing, textiles

Per

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2011

2012

2013

www.oas.org/rcss

FOCUS ON CHILDREN’S PRODUCTS

PREMARKET REQUIREMENTS (CHILDREN’S PRODUCTS)PRODUCT SAFETY: NORTH AMERICA

Canada

United States

Mexico

Identify requirements (physical, mechanical, chemical) and conduct testing to demonstrate compliance.

Identify requirements (physical, mechanical, chemical), conduct third party laboratory testing, issue children’s product certificate (CPC), affix permanent tracking marks on product and packaging. Durable infant and nursery products require product registration cards.

Identify requirements (physical, mechanical, chemical) Third party laboratory testing and certification in several products such as:• Electric and electronics products (including toys)• Electric and electronic artifacts• Children products (strollers, baby walkers and playing yards)

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SAMPLE: STROLLERSPRODUCT SAFETY: NORTH AMERICA

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Full-size Stroller Umbrella Stroller Travel System Carriage

Tandem Stroller Side-by-Side Stroller

Multi-Occupant stroller Jogging stroller

PREMARKET REQUIREMENTS – CHEMICALPRODUCT SAFETY: NORTH AMERICA

Canada

United States

Mexico

Carriages and Strollers Regulations (Physical & Mechanical, Surface Coatings, Flammability)Phthalates Regulations (Vinyl)

15 USC Section 1278a (Lead Content)16 CFR Part 1303 (Lead in Paint and Surface Coatings)

NOM-252-SSA-1.- Limits on heavy metals and small parts in toys

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PREMARKET REQUIREMENTS – PHYSICAL & MECHANICALPRODUCT SAFETY: NORTH AMERICA

Canada

United States

Mexico

Carriages and Strollers Regulations (Physical & Mechanical, Surface Coatings, Flammability)

16 CFR Part 1227 (Strollers) (Effective 9/10/2015) Based on ASTM 833-13b with modifications

16 CFR Part 1303 (Small Parts) (Part of 16 CFR 1227 upon effective date.)

NOM-133/1-2-3 from SCFI.- Infant Products – Baby Walkers, Strollers, and Portable Playground

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PREMARKET REQUIREMENTS – TESTING REQUIREMENTSPRODUCT SAFETY: NORTH AMERICA

Canada

United States

Mexico

Suppliers are responsible to ensure their products do not pose a danger to human health or safety. There are no specific certification requirements, but there are recommended practices:• Testing should be completed on a representative sample• Preferably use an accredited ISO 17025 laboratory

Initial Certification Testing: Children’s products must be tested for compliance at CPSC-accepted laboratories.

Periodic Testing: Children’s products with continuing production must be retested and recertified at a minimum of once every year, except for those manufacturers conducting additional production testing. 16 CFR Part 1107.

Material Change Testing: Material changes require a retest of the product or of the component part that was changed.

Batch Certification

Initial Certification Testing and Follow Up Testing (1 year). An importer to Mexico can summit laboratory testing results completed outside from Mexican territory to the authorities (Secretary of Economy) for possible recognition.

Certification for production line (3 years); Certification by fabric (3 years)

Add

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PREMARKET REQUIREMENTS – STROLLER LABELING REQUIREMENTS*

PRODUCT SAFETY: NORTH AMERICACanada

United States

Mexico

The following information must be permanently affixed to the stroller, in English and French:1. Name and place of business in Canada of manufacturer or importer;2. Model name or number;3. Date of manufacture (year and month);4. Warning statements about the assembly instructions, proper use of products and other statements specified in the Carriages and Strollers Regulations.

Every product shall bear or be accompanied by legible written assembly instructions, in English and French, with line drawings or photographs to illustrate the sequence of steps where needed.

The following information must be permanently marked on the stroller and its packaging (ASTM 833-13B):

WARNING Never leave child unattendedWARNING Avoid serious injury from falling or sliding out. Always use seat beltWARNING Child may slip into leg openings and strangle.Never use in reclined carriage position(s) unless (manufacturer to insert product specific instructions). ( This warning is not required on units that do not have openings or that automatically reduce the size of all openings.)

Products with a removable-wheel fork assembly shall contain additional warning statements and symbols.

NOM-050-SCFI - Información Comercial – Etiquetado General de Productos – General Labeling for Consumer ProductsWarning statements for use and special precautions *This list is only a sample and it is not comprehensive.

Add

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PREMARKET REQUIREMENTS – GENERAL LABELING REQUIREMENTSPRODUCT SAFETY: NORTH AMERICA

Canada

United States

Mexico

Under the CCPSA, there are prohibitions related to the packaging labeling or advertisement of a consumer product in a manner that is false, misleading or deceptive in respect of its safety or its compliance with a safety standard or the regulations.

Permanent Tracking Label: The manufacturer must permanently affix distinguishing information (generally referred to as “tracking labels”) to the children’s product and its packaging.Product Registration On-Product Marking: (Durable infant and toddler products only.) The manufacturer must permanently place the manufacturer name and contact information, model name and number, and the date of manufacture on each product.Information may be combined on a single label.

NOM-050-SCFI - Información Comercial – Etiquetado General de Productos – General Labeling for Consumer ProductsWarning statements for use and special precautions

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SALES REQUIREMENTSPRODUCT SAFETY: NORTH AMERICA

Canada

United States

Mexico

The person responsible (manufacturer or importer) must keep documents that show that a stroller meets the requirements of the Regulations, for a period of at least three years after the date of its manufacture in Canada or the date of its importation. The person responsible must provide an inspector with any documents that the inspector requests in writing, within 15 days after receipt of the request.

Manufacturers and importers must furnish a “Children’s Product Certificate” (CPC) to retailers & distributors. CPCs must also accompany the applicable product or product shipment. (This can be a website URL on a document.)Durable infant & toddler products, like strollers, must have postage pre-paid product registration cards affixed to the product for the consumer & maintain in a separate database in case of recalls.

Manufacturers and importers must furnish a “Product Certificate for Strollers” to retailers & distributors. The certificate must also accompany the applicable product or product shipment. (This can be a website URL on a document.)

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POST-SALES REQUIREMENTS REPORTING OBLIGATIONS

Canada

United States

Mexico

Companies must report to Health Canada within two days after becoming aware of an incident related to their consumer product. An incident is:

1. an actual or potential death or serious adverse health effect2. a defect that resulted in an actual or potential death or serious adverse health effect3. incorrect or insufficient information on a label or instructions that resulted in an actual or

potential death or serious adverse health effect4. a recall of the product in another jurisdiction.

Manufacturers and importers must submit an additional report within ten days. www.healthcanada.gc.ca/reportaproduct

Companies must fully and immediately report information re: (i) a defective product that could create a substantial risk of injury to consumers; (ii) a product that creates an unreasonable risk of serious injury or death; (iii) a product that fails to comply with an applicable consumer product safety rule; (iv) certain choking incidents and (v) certain lawsuits. Full details at: www.cpsc.gov/reporting

There is no specific obligation to report an incident to Profeco, but legal authorities advise doing so as a proactive measure to reduce risks in case of any legal process brought against a company for any injury or death caused by the product. To contact authorities and/or to report any potential risk: http://www.alertas.gob.mx/ .

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RECALLSPRODUCT SAFETY: NORTH AMERICA

Canada

United States

Mexico

Recall is a corrective measure that is used to communicate the danger to human health or safety posed by a consumer product. It accomplishes two tasks:• communicates the danger related to a product to consumers who may possess it; and• informs consumer about what, if any, corrective measures are available that either bring

the product into compliance or reduce/remove the danger to human health or safety, posed by the product to consumers.

May lead to recall-related activities such as recall monitoring.www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/index-eng.php

A typical corrective action plan (CAP) agreement outlines:• a comprehensive communication plan (consumer notification), • the remedy to be implemented (repair/replace/refund/ warn), and• specifies a recall monitoring plan and specific steps to take to dispose of or repair

the products. www.cpsc.gov/recallguidance

Mutual agreement between Profeco and the responsible party to communicate the danger of a product and the process to recall it from the market or consumers who posses it, in order to repair, replace or refund.

Specifies a recall monitoring plan and specific steps to take to dispose of or to repair the products. http://www.profeco.gob.mx/verificacion/alertas_nvo.asp

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Joint Recalls

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JOINT RECALLS: CRITERIA• Product sold in at least 2 or all 3 countries• Product must also be under the jurisdiction

of both agencies• Corrective measures and customer support

extended to customers in affected countries• Timing works for regulator & company• Have agreement from company to share all

information with both jurisdictions early in the process

• Recall is conducted voluntarily26

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Joint RecallsJOINT RECALLS

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Joint RecallsJOINT RECALLS

CONCLUSION

• Although consumer product safety requirements may vary, we share the goal of safe products in the North American market.

• Greater cooperation between regulators and industry can help to ensure the efficient flow of goods between jurisdictions while respecting product safety requirements.

• Joint recalls present an opportunity for industry to efficiently address one of the requirements in each jurisdiction with minimal additional efforts.

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KEY RESOURCESHealth Canada

www.healthcanada.gc.ca/cpswww.healthcanada.gc.ca/reportaproductwww.hc-sc.gc.ca/cps-spc/pubs/indust/index-eng.php

www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/index-eng.php

Consumer Product Safety Commissionwww.cpsc.gov/BusinessEducationwww.cpsc.gov/DesktopGuidewww.cpsc.gov/Testing www.cpsc.gov/DurableInfantProducts

Profecowww.profeco.gob.mxwww.profeco.gob.mx/Servicios/tel_cons.as

www.profeco.gob.mx/verificacion/est_comer.asp www.profeco.gob.mx/verificacion/laboratorio.asp

Mexico

Thank You / Merci / Gracias Panelists:

Sonia DouglasConsumer Product Safety ProgramHealth Canada [email protected]

Neal S. Cohen Small Business OmbudsmanU.S Consumer Product Safety [email protected] @CPSCSmallBiz

Agustín AdameSubprocuraduría de Verificació[email protected]

Health Canada

United States Consumer Product Safety Commission

Mexico