The presentation provides an overview of the U.S. Consumer Product Safety Commission's Office of Compliance and Field Operations. It discusses how the office works to identify product hazards through surveillance activities and in-depth investigations. It outlines the process for mandatory reporting of product defects and describes trends in voluntary recalls and corrective actions. Priorities are identified, including implementation of enforcement programs and review of internal procedures to ensure more timely response. Contact information is provided for those seeking additional guidance.

1. U.S. Consumer Product Safety Commission
Office of Compliance and Field Operations
Safety Academy
September 20, 2012
Marc J. Schoem
Acting Director
This presentation was prepared by CPSC staff, has not been reviewed or approved by,
and may not reflect the views of the Commission.

2. Overview
Office of
Compliance and
Field Operations
Defect Regulatory Field
Investigations Enforcement Investigations
Division Division Division
by Hazard by Hazard by City/State
2

3. Compliance Meeting CPSC Strategic Goals
• Rigorous Hazard Identification
• Retail Product Surveillance – Sample Collections
• Internet Website Surveillance
• Resale and Thrift Store Product Surveillance
• In-Depth Investigations
• Supporting Import Surveillance at Ports
• Decisive Response
• Establishment Inspections
• Identification of Defective and Violative Products
• Timely Investigations and Preliminary Determinations
• Timely Referrals to OGC of Potential Section 15(b)
Reporting Violations
3

4. Compliance Activities
Defect Enforcement of Corrective
Investigations Rules and Bans Actions/Recalls
Market Field Import
Surveillance Operations Surveillance
Sanctions/
Penalties
4

5. Surveillance Databases
IPII DTHS INDP NEISS
National
Injury and In-Depth Electronic
Death
Potential Injury Investigations Injury
Certificates
Incident Data (IDIs) Surveillance
System
5

6. In-Depth Investigations
7,000
6,178
6,000 5,513
5,277
5,036 5,057 4,984 4,840
5,000 4,614 4,746
4,295
4,000
3,800
3,000
2,000
1,000
0
FY02 FY03 FY04 FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12
as of
9/18
6

7. Surveillance Activities
• Program plan for regulated
products; surveillance for defects
Retail and other risks
• Check for conformity with
regulations and for recalled
Internet products
• Investigators at key ports of entry
Ports and • Analysts identify most likely at-
risk products
Airports
7

8. Reporting Under Section 15
• 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.
8

9. Reporting Under Section 15
What to Provide When Reporting
Initial Report
• Details about product, stop sale date, potential defect
and hazard, samples, and all available information
Full Report
• All information requested in 16 CFR §1115.13 with
regard to manufacturer, product, defect, and injuries
9

10. Section 15 Reporting Trends
10

11. Overview of the Section 15
Defect/Hazard Process
Contains Defect
Section 15 Action Against
Report/ the Product
Sample Preliminary
PI/CA Case Determination
No Action
Against the
Evaluation by Expert Staff Product
Engineering,
Human Factors,
Health Sciences
11

12. Identifying Defect/Hazard
• Pattern of Defect
• Identification of defect, flaw, error and issues
associated with design, engineering, quality
control, labeling, use, assembly.
• Number of Defective Products
• Distributed into commerce
• Severity of Risk
• Severity of injury
• Likelihood injury will occur
• Vulnerable population affected
12

13. Overview of the Regulatory Process
Banned Or
Misbranded
Product
Testing for the
Regulatory •
standard
13
Corrective
Case Action Plan
Applicable No Action
Regulation Against the
Product 13

14. Implementing a Product Safety Recall
Decision to Recall
Stop Production
Redesign?
Stop Distribution Repair? Disposal?
Stop Retail Sales
Consumer Return for Incentives/
Repair/Replace
Notification Refund Disposal
14

15. Fast Track Case Percentages
of All Section 15 Reports
100%
90%
80%
70%
57% 56% 56%
60% 54% 52%
52% 51%
48% 49% 48%
50% 43%
40%
30%
20%
10%
0%
FY 02 FY 03 FY 04 FY 05 FY 06 FY 07 FY 08 FY09 FY10 FY11 FY12 as of
9/18
15

16. Voluntary Recalls by Fiscal Year
16

17. Recalls and LOAs by Fiscal Year
2,109
2000 1,907
1900
1800
1700 1,627
1600
1500
1400
1300
1200
1100 1,029
1000 915
900
800 681 704
700 618
600 473 478 498 476
500 413 422
400
300
200
100
0
FY06 FY07 FY08 FY09 FY10 FY11 FY12 as of 9/18
Recalls LOAs
17

18. Violations/Prohibited Acts
Manufacturing, distributing, or
importing any product that does not
comply with a mandatory standard
Failing to report information as
required by CPSC statutes
Selling a recalled product
Exporting a recalled product for sale
18

19. Office of Compliance and Field Operations
Priorities
• Implementation of Field Investigative Enforcement Programs
Cribs Mattresses
VGB Pool Safety Act Bed Rails
Fireworks Toddler Beds
Toys Baby Walkers
Children’s Sleepwear Bath Seats
• Testing & Certification Requirements for Children’s and
Non-Children’s Products.
19

20. Office of Compliance and Field Operations
Priorities
• Recall Effectiveness
• Review Use of Product Registration Cards
• Review Use of Social Media
• Review of Internal Procedures
• Review and Update of Defect and Regulatory
• Procedures and Investigative Letters
• Advance Section 6(b) Notice of Investigations
• More Timely Response
• Broader More Consistent Public Notification Through
Voluntary Corrective Actions Plans and Letters of
Advice
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21. Office of Compliance and Field Operations
Priorities
Recall Monitoring
Reverse Logistics
• Reverse distribution or product return
• how you get the product back from distribution
• Reverse logistics plan should outline details such as:
• how to quarantine the product
• how to get the product returned
• how to remove the product from shelves
• how to repair, replace, or dispose of the product
• Provide your reverse logistics plan to Compliance staff with your
Corrective Action Plan (CAP) and Full Report.
21

22. Office of Compliance and Field
Operations Priorities
Use of Social Media in Consumer Notification
22

23. Industry Guidance
• www.cpsc.gov
• “Business” section of website
• www.recalls.gov
• Monitor CPSC Activities through:
• Frequently Visiting CPSC Website
• Recall Announcement Subscriptions
• Public Calendar Subscriptions
• CPSC Electronic Reading Room Inquiries
• CPSC Clearinghouse Letters
• Seminar Attendance (Trade Shows/ICPHSO)
• CPSC Public Database
23

24. Contact Information
Marc J. Schoem
Acting Director
Office of Compliance and Field Operations
U.S. Consumer Product Safety Commission
mschoem@cpsc.gov
301-504-7520 – phone
240-638-6955 – mobile
24

25. Consumer Product Safety
•
Commission
Mr. Dean W. Woodard U.S. CPSC
Director Office of Education, Global Outreach, and Small
Business Ombudsman
dwoodard@cpsc.gov
business@cpsc.gov