consumer product safety – is your compliance program adequate?
TRANSCRIPT
Consumer Product Safety –Is your Compliance Program Adequate?
Blasius Consulting LLC
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Quality Certification AllianceNovember 13, 2017 Webinar
Ph. #262-650-1216
[email protected] Views expressed in this presentation are those of Dennis Blasius and do not necessarily represent the views of the CPSC
Agenda
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Who Is the CPSC?
Who is the U.S. Consumer Product Safety Commission?
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CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard.
Deaths, injuries, and property damage from
consumer product incidents cost the
nation more than $1 trillion annually.
$1 Trillion
CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters, and household chemicals -contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 40 years.
CPSC is a federal government agency charged with protecting the public from unreasonable risks of injury or death associated withthe use of the thousands of types of consumer products under the agency's jurisdiction.
CPSC
What Is CPSC’s Focus?
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Products that fail to comply with a mandatory safety standard or ban under the Acts
Products that fail to comply with voluntary/ consensus standards relied upon by the Commission
Products containing a defect which could create a “substantial product hazard”
Products that create an “unreasonable risk” of serious injury or death
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Source Data
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Hot Line reports
Public Database
Civic Groups
Attorneys
Retailers
State Death Certificates
Newspapers, radio, television, Internet, trade blogs, etc.
Fire & police reports, Non-MECAP coroners, hospitals
MECAP Reports
Consumers
Internet Surveillance
Medical Professionals
Trade Complaints
U.S. Consumer Product Safety Commission
Intake & Identification
› Data Intake› Triage/ Epidemiology› Import Surveillance
Investigation & Analysis
Enforcement
Standards
Planning, Management, and Evaluation› Commission › Executive Director / AEDs
Integrated Teams› Compliance› Field› Engineering› Lab› Health Sciences› Economic Factors
Industry Relations› Ombudsman › Clearinghouse
Education and Awareness› Public Affairs › Office of Education
International / GovernmentIntergovernmental Affairs
Integrated Team Approach
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Consumers
Industry
Safety Professionals
Healthcare Providers
Medical Examiners
Fed/State/Local Agencies
International
Customs & Border Patrol
Administration
Congress
Customs & Border Patrol
Industry
Consumers
Media
International
Fed/State/Local Agencies
CPSA 16 C.F.R. Section 1009.8 Criteria
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Eight general criteria to be applied for establishing priorities:
Frequency and severity of injuries
Causality of injuries
Chronic illness & future injuries
Cost & benefit of CPSC action
Unforeseen nature of the risk (“hidden” hazard)
Vulnerability of the population at risk
Probability of exposure to the hazard
Additional Criteria
Agenda
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What Does the CPSC Do to Ensure Unsafe Products Do Not Reach U.S. Consumers?
Global Challenges
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Complex & Dynamic Supply Chains
Multiple Trade Agreements
Uneven Safety Requirements
Rising Number of Regulations
Marketplace Surveillance
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RetailProgram plan for regulated products, surveillance for defects and other risks
InternetCheck for conformity with regulations and for recalled products
Ports & Airports› Investigators at key ports of entry› Analysts identify most likely at-risk
productsMarketplace Surveillance
Commercial Targeting and Analysis Center (CTAC)
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FSISAPHISPHMSA
NHTSA HSINOAACPSC
FDA
FWS
EPA
CBP hosts 10 Federal Agencies at the CTAC
› Partner agencies have signed a collective Memorandum of Understanding to share information and systems access.
› Other appropriate federal agencies may be added to CTAC in the future.
ITDS / RAM Benefits
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Port inspectors receive risk-scored entry data through CPSC systems for products of concern.› Policy› Inherent Product Risk
› Supply Chain› Violation History
› Recall History
Allows for decisive action
Improve coordination with CBP on holds and exams
Improves coordination
Facilitates movement
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CPSC National Product Testing & Evaluation Center Testing Areas
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Combustion Products Test Lab
Toy Test Lab Children’s Products Lab
Modern Conference Space Flammability/Fire Test LabMachine Shop
General Product Test Lab Outdoor Power Sports Lab Electrical Products Test lab Chemistry Lab
Pool & Spa Products Lab Impact Lab (Bike Helmets)
Exportation/Destruction/Seizure
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Exportation/Destruction› Importer may ask to export or destroy
at any time› Exportation or destruction will occur
under government supervision
Seizure› CPSC can request CBP to seize the product› Once seized, CBP takes over the process
» Fines, Penalties and Forfeitures Office issues notice; CBP has authority to remit forfeiture upon terms and conditions deemed appropriate
CPSC Letters of Advice
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› Sent to firms with a regulatory violation
› Remedies vary:• Seizure most common, if it’s a
repeat offender and product cannot be reconditioned
• Correct future production• Stop sale and correct future
production• Distribution-level recall• Retail level-recall• Consumer-level recall
› Compliance inspections
Common Import Violations/Defects
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Children’s Products
Tracking labels
Certifications
Lead(content)
Phthalates
Small parts
Lead(paint)
Toy standard
Art materials labeling
Non-Children’s Products
Fireworks
Hair dryers
Holiday lightsCigarette & multi-purpose lighters
Bicycle helmets
Certifications
Luminaries
Mattress flammabilityExtension cords
Agenda
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Product Safety Requirements: Testing & Certification
CPSIA Requirements
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1Consumer Product Safety Improvement Act of 2008 (CPSIA) -imposes requirements for consumer products; non-children’s, & children’s.
Manufacturer or importer must issue a certificate to indicate that
the product complies based on third party test results.
CPSIA
CPSIA Requirements - General Use Products
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Any laboratory can perform the testing for non-children’s products. Third party testing is not required. Testing
A General Certificate of Conformity (GCC) is required for all products subject to a rule, ban, standard, or regulation enforced by the CPSC.
Certification
CPSIA Requirements - Tracking Labels
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Require manufacturers of children’s products, to the extent practicable, to place distinguishing marks on a product and its packaging that would enable the purchaser to ascertain the source, date, and cohort (including the batch, run number, or other identifying characteristic) of production of the product by reference to those marks.
Regulatory Robot Welcome
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Agenda
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E-Commerce Sales to U.S. Consumers & Distributors
E-Commerce as a Percent of Retail Sales
23Source: U.S. Census Bureau, Quarterly Retail E-Commerce Sales, Released February 17, 2017
3.5 3.6
4.24.6
5.15.5
6.1
6.6
7.5
8.3
0
1
2
3
4
5
6
7
8
9
1 2 3 4 5 6 7 8 9 10
E-Commerce as a Percent of Retail Sales
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3.5
3.6
4.2
4.6
5.1
5.5
6.1
6.6
7.5
8.3
0 1 2 3 4 5 6 7 8 9
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Source: U.S. Census Bureau, Quarterly Retail E-Commerce Sales, Released February 17, 2017
Common Internet-Related Activities
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Analyze consumer reviews to identify additional injury and death incidents.
Respond to trade complaints or consumer reports of potentially unsafe products being offered for sale.
Search for previously recalled or banned consumer products that are being offered for sale/re-sale
Identify new products as they are being introduced into the marketplace.
Purchase exemplar samples for testing.
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0405
Identification & Removal of Hazardous Products
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IdentifyIdentify Offers to Sell Consumer Products that have been Recalled or are Banned–Complaint Follow-Up or Keyword Searches
CautionRequest Voluntary Removal Of Sales Offer
Legal ReferralConsider Possible Legal Action to
Compel Compliance
EscalateRequest Website Management
Removal of Sales Offer
ResearchResearch Website Ownership &/ or Individual Seller
InspectionInspection of Website
Company/ Inventory
Agenda
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Designing Safety into Your Products
Design for the Supply Chain
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Supply Chain Management
(SCM)
CONCEPT
DESIGN
DEVELOPMENT
PRODUCTION
DISTRIBUTION
Supply Chain Management is a process of obtaining information about the product throughout the entire product life cycle.
Establish a Compliance Program
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Institute internal controls and procedures to capture appropriate data• Returns from distribution chain• Parts orders• Consumer complaints, claims, lawsuits, online
product reviews• Retailer reports/feedback• Incidents reported to/posted on SaferProducts.gov
Disclose required information to
regulators
Update and review controls & procedures
Provide employees with compliance training, and the mechanism to report
issues
Supply Chain Management
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Monitor the entire chain
Catch problems early in the process to minimize costly delays at the ports
Retailers asking for greater visibility into manufacturer’s supply chains
Traceability is key! Know your suppliers
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Identify Product HazardsKnow the Hazards Associated with your Product
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Life Threatening/ Serious Injury
› Strangulation› Entrapment› Positional Asphyxia› Fall/Head Injury› Choking/Ingestion/Aspiration› Drowning› Shock/Electrocution› Fire/Burn› Amputation› Laceration› Fracture
› Eye Injury› Impalement› Fall
Recalls by Category (FY12-FY16)
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329
272
212
180140
113
111
89
82
63
55
49
40
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296
Sports, Fitness, & Recreation
Children's Products
Clothing and Accessories
Home Electronics Kitchen Appliances and Supplies
Furniture
Lamps, Lights & Lighting Equipment
Home Goods
Lawn and Garden
Motorized Vehicles
Heaters or Heating Systems
Tools
Hair Grooming Equipment or Accessories
Holiday/Seasonal
Other
Safety Culture
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Establish a formal safety design review
team Design safety into the product
Develop a rigorous in-house test program that goes beyond the
minimum standards Conduct safety
reviews at critical stages
of product design
Design for intended and unintended
foreseeable use
Reporting Under Section 15
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When to Report
The manufacturer, importer, distributor, or retailer is required to report immediately upon obtaining information which reasonably supports the conclusion that a product:
› Fails to meet a rule, regulation, standard, or ban under the CPSA or any other statute enforced by the CPSC;
› Contains a defect which could create a substantial product hazard to consumers; or› Creates an unreasonable risk of serious injury or death
Corrective Action
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The CPSA provides for three remedies in the case of the recall of a product that creates a substantial
product hazard3
Repair
Replacement
Refund
3 15 U.S.C. § 2064(d).
Penalties
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Any person who knowingly commits a violation is subject to a civil penalty. The CPSIA increased the civil penalty caps from $8,000 to $100,000 per individual violation, and from $1,825,000 to $15,000,000 for aggregate violations.
Criminal penalties (including felony conviction and imprisonment for up to 5 years) are also possible for known and willful violations
Consumer Product Safety Consulting Services
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If you have questions, Dennis Blasius can help with your Consumer Product Safety Compliance Consulting needs.
Is your internal compliance program adequate?
Do you know what is reportable to the CPSC under Section 15(b)?
Are you wondering if the information you have rises to the level of a substantial product hazard, triggering immediate reporting requirements?
Have you ever wished that you could anticipate CPSC’s response?
Defect Investigations
Substantial product hazard questions
Regulated Product Compliance
Recall Effectiveness
Reporting requirements-when/how to report effectively
CPSC inspections- are you prepared & what you can expect
Marketplace surveillance considerations
E-commerce retail compliance
Internal staff training
