Practical Considerations During Multi-Jurisdictional Recalls In U.S. – Canada Reporting and Regulatory Requirements Key Elements Practical Considerations Challenges Encountered

International Cooperation: Memorandum of Understanding CPSC – Health Canada (June 22, 2005) II. Collaborative Process and Information Sharing C. …Participants may share information that is within the scope of the mandate and authority of each Participant, and which includes… (c) Information on product recalls of consumer products known by the CPSC to have been manufactured, advertised, or distributed in Canada, and on such products known by HECS to have been manufactured, advertised, or distributed in the United States; R EPORTING AND R EGULATORY R EQUIREMENTS

International Cooperation: Memorandum of Understanding CPSC – Health Canada VII. Duration and Process A. This MOU comes into effect upon signature and is to continue in effect for a period of ten (10) years. At the end of first year, the Participants intend to jointly review this MOU and make adjustments as necessary. (Emphasis added.) R EPORTING AND R EGULATORY R EQUIREMENTS

Products Outside the U.S.: Final Policy Statement Guidance Document – Section 15 Reporting Potentially Hazardous Products Manufactured or Distributed Outside the U.S. (June 7, 2001). CPSC Interpretation of 15 U.S.C. § 2064(b) and 16 C.F.R. 1115, Substantial Product Hazard Reports. “…information concerning products manufactured or sold outside the United States that may be relevant to evaluating defects and hazards associated with products distributed within the United States should be evaluated and may be reportable under Section 15(b).” 66 F.R (June 7, 2001) R EPORTING AND R EGULATORY R EQUIREMENTS

CPSC Policy Statement – Products Outside U.S.  (1) “Nothing in the reporting requirements of the CPSA or the Commission’s interpretative regulation at 16 C.R.F. Part 1115 limits reporting to information derived solely from experience with products sold in the United States.” 66 F.R , (June 7, 2001)  (2) “The Commission interprets the statutory reporting requirements to mean that, if a firm obtains information that meets the criteria for reporting listed above and that is relevant to a product it sells or distributes in the U.S., it must report that information to the CPSC, no matter where the information came from.” Id. R EPORTING AND R EGULATORY R EQUIREMENTS

Coming Changes in Canadian Recall Authority Bill C-6: Canada Consumer Product Safety Act (CCPSA)  “…if an inspector believes…that a consumer product is a danger to human health or safety, they may order a person who manufactures, imports, or sells the product for commercial purposes to recall it.” Clause 30.(1)  “An inspector may order a person who manufactures, imports, advertises, or sells a consumer product to take any measure…in subsection (2) if… (c) the inspector believes…the product is the subject of a measure or recall undertaken voluntarily by the manufacturer or importer;” Clause 31.(1) R EPORTING AND R EGULATORY R EQUIREMENTS

Coming Changes in Canadian Recall Authority  “The measures include… (a) Stopping the manufacturing, importation, packaging, storing, advertising, selling, labeling, testing, or transportation of the consumer product or causing any of those activities to be stopped; and Id.  “any measure that the inspector considers necessary to remedy a non-compliance with this Act or the regulations…” Clause 31.(2) R EPORTING AND R EGULATORY R EQUIREMENTS

K EY E LEMENTS : H OW D OES THE S AUSAGE G ET M ADE ?  Product Match  Were same products sold in both jurisdictions?  Does CPSC and Health Canada have jurisdiction over both products? (Ex. ATVs)  Reciprocal Voluntary Recall Requirements  Incidents/Injury Reporting  Advantage to Precision – where did Incident-Injury occur?  Does absence of Incident/Injury in a Jurisdiction remove obligation?  Matching Launch Dates  Can all three entities move to recall launch at the same pace?  Do different launch dates remove effective media exposure?

K EY E LEMENTS : H OW D OES THE S AUSAGE G ET M ADE ?  Required Language of Press Release/Recall Posting  Hazard Language – what is defective about the product?  “Look and Feel” – CPSC Press Release vs. Health Canada Posting  Units, Number Sold, Number Distributed in each Jurisdiction  Effective Measurements  What is the appropriate yardstick?

K EY E LEMENTS Product Jurisdiction children’s products consumer products used in home, sports, recreation, and schools ATVs No Jurisdiction automobiles, trucks, motorcycles, tires, car seats boats cosmetics radioactive materials electric product radiation pesticides, rodenticides, fungicides other : (foods, medical devices, drugs, etc.) children’s products household products (including household chemicals) cosmetics (including personal care products) new chemical substances products of biotechnology workplace chemicals radiation-emitting devices ultraviolet radiation noise

K EY E LEMENTS Reciprocal Impetus for Voluntary Recall? Declare “a product, material, or substance” to be “prohibited,” “restricted,” or “controlled” Hazardous Products Act, (R.S., 1985, c. H-3). “prohibited” products illegal to sell, advertise, or import “restricted” products may be sold, advertised, or imported by regulation “controlled” products require specific information disclosure on a safety data sheet Impetus may change with new recall authority extended in proposed CCPSA Bill C-6, proposed CCPSA Section 15(b) voluntary recall was originally the CPSC “No Preliminary Determination” Program 62 F.R “The [CPSC] refrains from making preliminary hazard determination when final report and with 20 working days implement an acceptable corrective action.” Id. Mandatory recall where “Commission determines” product presents a substantial product hazard 15 U.S.C. § 2064(c), Section 15(c).

K EY E LEMENTS Template Requirements Press Release [Headline] [Introductory Paragraph] Name of Product Units Distributor (if U.S. entity) Manufacturer Hazard Incident/Injuries Description Sold at/Sold by Manufactured in (Country) Remedy [Images] Recall Notice Date Product Name Full Product Description Hazard Identified Corrective Action Number Sold Time Period Sold Companies Images

K EY E LEMENTS Template Requirements Press Release [Headline] [Introductory Paragraph] Name of Product Units Distributor (if U.S. entity) Manufacturer Hazard Incident/Injuries Description Sold at/Sold by Manufactured in (Country) Remedy [Images] Recall Notice Date Product Name Full Product Description Hazard Identified Corrective Action Number Sold Time Period Sold Companies Images

P RACTICAL C ONSIDERATIONS : W HAT W ORKS B EST ?  Guide Recall through Most Stringent Regulatory Requirement  Create Single Report that meets Most Stringent Regulatory Requirement  Determine Confidential Data is protected in both jurisdictions  Translate Report to French Canadian  Cross-Notice same Report to both CPSC, Health Canada  Prepare Consistent Language for CPSC Joint Press Release and Health Canada Posting  Tailor to individual agency formats

P RACTICAL C ONSIDERATIONS : W HAT W ORKS B EST ?  Press for Matching Launch Dates  Release of Joint Press Release, Postings, Other Media  Website Pages Live/Links Live  Stronger Media Exposure at Launch  Cross-Notice Website Links  Firm Agencies  Agencies Firm  Agency Agency  Single Counsel Reporting to CPSC, Health Canada  Facilitate Coordination with Firm, Between Agencies  Guide product remedy, repair, destruction  Guide Joint Progress Reporting

C HALLENGES E NCOUNTERED  Different Degrees of Protecting Confidential Business Information  Presence of Consumer Reports in Affected Jurisdiction  Why Voluntary Recall where Compliance is Correct and Mandatory Recall is not available to agency?  Why Recall where Incident /Injury did not occur in that jurisdiction?  Exact Compliance Requirements  Different Threshold Levels for lead, phthalates, BPA, etc.  Exact Product Matches  Different Lines, Different States  Different Manufacturing or Distribution Dates  Coordinating Launch Date where Recall is not “Joint”  Preparing Consistent Public Documents  Arriving at a Consistent Evaluation of the Product Hazard  Effectiveness Measurement

Thank You. M ARK A. K INZIE AVERTURE T WO C ITY P LACE D RIVE, S UITE 200 S T. L OUIS, MO