2013 Compliance with Mandatory Reporting Requirements, Regulatory Violations, Compliance Investigations and Recalls

1. Safety Academy
Reporting Requirements, Regulatory
Violations, Investigations and
Recalls
September 18, 2013
Views expressed in this presentation are those of the staff, and do not necessarily
represent the views of the Commission

2. Reporting Requirements
2
 Section 15(b) of the Consumer Product
Safety Act establishes reporting
requirements for manufacturers, importers,
distributors and retailers of consumer
products, over which the Commission has
jurisdiction.
 Each must notify the Commission
immediately if it obtains information which
reasonably supports the conclusion that a
product distributed in commerce:

3. Reporting Requirements
 (1) fails to comply with an applicable
consumer product safety rule or with a
voluntary consumer product safety standard
upon which the Commission has relied
under section 9, or
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4. Reporting Requirements
 (2) fails to comply with any other rule,
regulation, standard or ban under the CPSA or
any other Act enforced by the Commission,
including the:
 Flammable Fabrics Act,
 Federal Hazardous Substances Act,
 Children’s Gasoline Burn Prevention Act,
 Virginia Graeme Baker Pool and Spa Safety Act,
 Poison Prevention Packaging Act, and
 Refrigerator Safety Act; or
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5. Reporting Requirements
 (3) contains a defect which could create a
substantial product hazard, or
 (4) creates an unreasonable risk of serious
injury or death.
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6. CPSC Office of Compliance
 Three divisions: Field Operations,
Regulatory Enforcement and Defect
Investigations
Regulated Products Enforcement Division:
 Enforces CPSC’s regulations and standards
 Conducts investigations
 Initiates and negotiates corrective actions
 Provides advice and guidance to industry
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7. Compliance Overview
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Compliant-
No Action
Violations-
Corrective
Action
Receive LOA
from CPSC
Stop-sale, remove
product from market,
recondition/correct,
order destruction,
correct, RECALL
Possible
Penalties

8. CPSC Jurisdictional Authority
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9. Violations/Prohibited Acts
The Statutes make it unlawful to:
• manufacture for sale, sell, offer for sale, distribute
or import any product that does not comply with a
mandatory standard or ban under any act the
Commission enforces;
• fail to report information as required by section
15(b) (CPSA);
• fail to certify; and
• fail to include tracking labels when appropriate.
9

10. Top Regulated Product Safety
Concerns
 Products that fail to comply with a
mandatory safety standard or ban under the
Acts
 Products that fail to have certification and
applicable GCC or CPC
 Products that fail to have tracking labels,
when appropriate;
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11. Imports
• Under section 17(a), a consumer product must be
refused admission to the United States if it:
– fails to comply with an applicable consumer
product safety rule (CPSA standard or ban)
– is not accompanied by a required certificate or
tracking label or is accompanied by a false
certificate
– is or has been determined to be imminently
hazardous in a section 12 proceeding
– has a defect that constitutes a substantial product
hazard
– was imported by a person not in compliance with
inspection and recordkeeping requirements.
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12. FY 2013 – Enforcement Actions
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13. All Regulated LOA’s, FY08-FY13
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14. Recalls by Product Origin
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15. Flammable Fabrics Act
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1. Wearing Apparel
2. Vinyl Plastic Film
3. Children’s Sleepwear
4. Carpets and Rugs
5. Mattresses, mattress pads
6. Mattresses, mattress pads
16 CFR Part and Title
1. 1610
2. 1611
3. 1615/1615
4. 1630/1631
5. 1632: Cigarette Ignition
6. 1633: Open Flame Ignition

16. CPSIA Requirements
• Consumer Product Safety Improvement Act of 2008
(CPSIA)—imposes new requirements for consumer
products, non-children’s and children’s.
• Non-children’s: A General Certification of
Conformity (GCC) is required for all products subject
to a rule, ban, standard, or regulation under and
enforced by the CPSC
– GCC shows conformance to applicable requirements
(e.g., flammability)
– manufacturer or importer must issue a certificate to indicate
that the product complies and why a test has not been
conducted.
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17. CPSIA Requirements-Children’s
 Children’s products: Many of the new
requirements are specifically for children’s
products.
 Children’s products are products designed
and intended primarily for children 12 years
or younger.
 Additional requirements for child care
articles, items that are used for
feeding/sleeping for children 3 years or
younger.
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18. CPSIA Requirements-Children’s
• Third party testing: Certification based on testing
performed by an accredited third party laboratory
recognized by the CPSC
• Children’s Product Certificate (CPC) required
– CPC shows conformance to applicable requirements (e.g.,
flammability, lead, phthalates), based on third party testing
• Lead content and surface coating limits must be met
for certain components of textile products.
– For example, buttons, snaps, grommets, zippers,
heat transfers, and screen prints
• Tracking labels required
• Child care articles (sleepwear, mattress for children 3
and under) subject to phthalates requirements 18

19. CPSIA Home Page
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20. Searchable List of Laboratories
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21. Reporting Under Section 15
We encourage reporting under Section 15:
 On our website at: www.cpsc.gov
 On right-hand side under “Businesses”
 Or via e-mail to: Section15@cpsc.gov
 Faster, easier to track and route
 Add photos and other documents
We discourage reporting via phone, mailed letter, or fax.
 Much slower, harder to track, and much easier to
get lost or duplicated during routing

23. 23

24. What to Provide When Reporting
Under Section 15
Initial Report
 Details about product, stop sale date, potential
defect and hazard, samples, and all available
information
Full Report
 All information (1-15), customer list, CAP,
notice documents, draft press release, test
reports, list of foreign countries sold to, reverse
logistics/disposal plan

25. FY12 Recall Case Breakdown
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51%
30%
19%

26. Compliance-Initiated Investigations:
Examples of Data Sources
 Consumer incident reports,
 news reports,
 fire officials,
 trade complaints,
 Congressional complaints,
 medical examiner reports,
 death certificates
 injury reports through NEISS – National
Electronic Injury Surveillance System – a
stratified probability sample of 101 hospitals26

27. Preliminary Investigations
 In-Depth Investigations (IDI) – Field
Investigator is assigned for on-site
investigation of a consumer incident
 Product Samples – an incident unit or
exemplar unit may be obtained.
Compliance works with CPSC technical
staff to evaluate defect and likelihood of
injury.
 Firms may be requested to submit a Full
Report
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28. Staff Preliminary Determinations
 After investigation is complete, staff from
Compliance, Engineering, and Compliance
Legal meet with Compliance management
to discuss the product defect and risk of
injury.
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29.  Recalls involving Compliance-initiated
investigations are 4 times more likely to
have reporting violations than firm-
reported recalls. Such cases are referred
to the Office of General Counsel for civil
penalty review.
 Civil penalties: up to $100,000 per
violation, maximum $15.15 million for
related series of violations.
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30. What is the Fast Track Program?
 Initiated in 1997, it eliminates “preliminary
determination” of hazard for cases reported
by a firm that can quickly implement a recall.
 WIN-WIN-WIN
• Firm no PD and can implement a recall
quickly
• Staff expends fewer resources
• Public gets quicker notice

31. What is the Fast Track Program?
 Firm must
• do public notice and initiate a stop sale quickly.
• Must implement an acceptable Corrective
Action Plan within 20 business days.
 Firm can do repair, replacement, or refund as
corrective action.
• Staff should get opportunity to review repair or
replacement before implementing.
 Firm must still provide a full report and all
requested information for a Fast Track recall.
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32. Conducting a Recall: Ways to Reach Public
 Hotline (toll-free)
 Posters at traditional retail locations (several
locations)
 Forums, trade associations, magazines for
industry, brochures, and catalogs
 Direct Notice is BEST (e-mail, letter, phone
calls)
• Review all internal customer lists (loyalty
cards, warranty, catalogues)

33.  Website (initiate online registration,
instructions)
 Social media (Twitter, Facebook,
Google+, Blogs)
• Firms expected to announce recalls on their
social media platforms
• CPSC is routinely using Twitter
 YouTube (recall message, how-to repair,
step-by-step instructions, how to
assemble) 33
Conducting a Recall: Ways to Reach Public

34. Choosing a Remedy
Refund/Replacement/Repair
 Refund is the fastest and easiest method for
consumers.
• Must consider if product will be returned
and how.
• Removal of piece can disable product and
be returned at lower costs.
• Pre-paid postage return for consumers.

35.  Replacement must be a comparable product.
• Requires review of test reports/data by
staff.
 Repair programs always need staff review.
• Can be done by consumer, technician, or
return to firm.
• If done by consumer, must be easy with
clear instructions.
• If tools required, should provide them.
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Choosing a Remedy
Refund/Replacement/Repair

36. Conducting a Recall
 Press Releases
• Recalls announced in press releases
due to lack of direct notice and need
for outreach.
• Can be pitched to media, can be
highlighted on CPSC’s main page,
tweet

37. Conducting a Recall
 Recall Alerts
• Very small percentage of recalls
• Requires direct contact for virtually
all consumers, retailers, and
distributors
• Still posted on CPSC website
• Must provide a customer list to
qualify for a Recall Alert
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38. Conducting a Recall
How to Speed Up the Recall Process
 Report electronically online or via Section 15
mailbox.
 Provide all required and requested information;
don’t make us ask for each missing item.
 Provide Full Report electronically in numbered
format (1-15), not in a narrative.
 Provide samples, test reports, and engineering
documents for repair or replacement programs
early in process for staff review.

39. Conducting a Recall
How to Speed Up the Recall Process
 Make sure we get press release in Word
format.
 Provide high-quality jpg photos of product.
 Respond promptly to technical questions.
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40. Recall Monitoring: Reverse Logistics
 Reverse of distribution or product return
• How you get product back from distribution
 Reverse logistics plan should outline details
such as how to:
• quarantine the product
• get the product returned
• remove product from shelves
• repair, replace, or dispose of product
 Provide your reverse logistics plan to
Compliance staff with your corrective action
plan (CAP) and full report.

41.  Important process to plan and avoid
having recalled products put back into
distribution
 Illegal to sell recalled products
 Track, Track, Track
• We need to know where your
products are going at all times.
41
Recall Monitoring: Reverse Logistics

42. Recall Monitoring
 CPSC staff monitors all recalls.
 You must provide monthly progress
reports via fax or e-mail until the case is
closed by staff.
 Use the progress report form provided
with CAP letter.
• Report incidents pre- and post-recall.

43. Recall Monitoring
 We will check on implementation of the
CAP through on-site recall checks with
the recalling company, retailers, and
consumers.
 Notify Compliance of any changes at
the firm or to the CAP.
• New POC, new address or phone,
hotline hours, bankruptcy or purchase
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44. Recall Monitoring: Ineffective Recalls
 Notify Compliance if CAP appears not to
have been effective.
 Compliance staff may seek additional
notification for post recall incidents,
ineffective notification, low correction rates.
• Re-announcement of recall
• Additional forms of notification
• Out-of-season recall group notification
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45. Recall Monitoring: Disposal
 Know if you will need special disposal for items like
batteries or electronics (federal, state, or local laws).
 If retailers will be disposing or destroying the product
or if you are using a third party, we need to know.
 Before you destroy, dispose, or recycle recalled
products, notify CPSC staff via e-mail to
recallproductdisposal@cpsc.gov .
 Field staff may witness destruction/ disposal/
recycling or require an affidavit to verify process.
 Notify us of plan as early as possible to coordinate
field staff.

46. Recall Monitoring
 Request to Compliance staff to close the
formal monitoring of recall case
 Provide monthly progress forms until you
receive a close letter from Compliance.
 Continue to honor recall requests for
remedy.
 Continue to post recall notification on firm’s
website after formal monitoring ends.
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47. For Further Information:
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www.cpsc.gov
Ray Aragon
Director,
Office of Compliance
and Field
Operations
301-504-7578
raragon@cpsc.gov
Blake Rose
Lead Compliance
Officer,
Defect Investigations
Division
301-504-7613
brose@cpsc.gov
Mary Toro
Director,
Regulatory
Enforcement
Division
301-504-7586
mtoro@cpsc.gov
U.S. Consumer Product Safety
Commission
4330 East-West Highway
Bethesda, MD USA 20814-4408