Hazardous Material Transportation

1. Hazardous Material Transportation Gale Prince, SAGE Consulting Tom Carney, Stericycle ExpertSUSTAINABILITY Erica Fransen, SuperValu

2. Session Objectives Understanding The Current Regulatory Environment Review of 2010 Food Safety Modernization Act Overview of Recall Trends Illustrate Costs and Benefits of Compliance Dispel Retail Hazardous Waste Myths Demonstrate Real World Data Define Critical Components of an Effective Retail Hazardous Waste Disposal Program Impact of Hazardous Waste on Reverse logistics

3. Food Safety Modernization Act2010 July 20, 2011 Gale Prince Gale@galeprince.com

4. Food Safety Modernization Act Key Focus Improving Capacity to Prevent Food Safety Issues Improving Capacity to Detect and Respond to Food Safety Problems Improving the Safety of Imported Foods

5. Effective Dates for Key Sections - “Immediate” Sec 101. Inspection of Records Sec 102. Registration of Facilities Sec 107. Fees Sec 201. Inspection frequency & Identification of High Risk Facilities Sec 206. Mandatory Recall Authority Sec 402. Whistleblower Protection

6. Improving Capacity To Prevent Food Safety Problems • Sec 101. Inspection of Records • “Reasonable belief” that use or exposure to an article of food will cause serious adverse health consequences or death • Have access to and to copy all records relating to such article and to any other article of food that FDA “reasonably believes” is likely to be affected in a similar manner.. (paper and/or electronic formats)

7. Improving Capacity To Prevent Food Safety Problems • Sec 102. Registration of Food Facilities • Registration with FDA Biennially • Even-numbered years – Oct to Dec • Domestic and Foreign • Suspension of Registration • If FDA has a reasonable probability of causing serious adverse health consequences or death to humans or animals FDA may suspend registration • cannot introduce food into Interstate or Intrastate Commerce • Hearing Provisions • Amend definition of “Food Establishment”

8. Improving Capacity To Prevent Food Safety Problems • Sec 103. Hazard Analysis and Risk-Based Preventive Controls • Hazard Analysis • Known and reasonably foreseeable hazards • Biological, Chemical, Physical, Radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, unapproved food and color additives, naturally occurring hazards • Unintentionally introduced hazards • Intentionally introduced hazards • Develop a written analysis of hazards

9. Improving Capacity To Prevent Food Safety Problems • Sec 103. Hazard Analysis and Risk-Based Preventive Controls • Preventive Controls may include: • Sanitation • Training • Environmental Monitoring • Food Allergen Control Program • A Recall Plan • Good Manufacturing Practices • Supplier Verification

10. Improving Capacity To Prevent Food Safety Problems • Sec 107. Authority to Collect Fees • Access and collect fees • For facility re-inspection following noncompliance • Those who do not comply with voluntary recall request

11. Improving Capacity To Prevent Food Safety Problems • Sec 111. Sanitary Food Transportation of Food • Shall promulgate regulations on sanitary food transportation (18 months)

12. Improving Capacity To Detect and Respond to Food Safety Problems • Sec 207. Administrative Detention of Food • Shall issue an interim final rule on detention based upon “reason to believe” and “is adulterated or misbranded”

13. Improving Capacity To Detect and Respond to Food Safety Problems • Sec 208. Decontaminated and Disposal Standards and Plans • EPA shall provide support for, and technical assistance in preparing for assessing, decontaminating, and recovering from an agricultural or food emergency

14. Improving Capacity To Detect and Respond to Food Safety Problems • Sec 206. Mandatory Recall Authority • Shall provide opportunity for voluntary recall when there is a reasonable probability that a product is adulterated • Will impose mandatory recall if firm is unwilling to voluntary recall

15. FDA Food Recall Trends From 2007 to 2009, FDA Food Recalls increased almost 400% Source: Comprehensive Recall Data Analysis 2010

16. U.S. Non-Food Recalls

17. Recall Effectiveness Report

18. OIG Report 2011 • Firms did not … • promptly initiate recalls • submit recall strategies • issue accurate recall communications to consignees • submit timely and complete recall status reports.

19. OIG Report 2011 • FDA did not… • Conduct firm inspections or obtain complete information on contaminated products • Conduct any audit checks of consignees • Review recall strategies and promptly issue notification letters • Witness the disposal of the products or obtain the required documentation showing the products had been properly disposed of

20. Alignment between Retailer and Manufacturer Removing Recalled Product from retail store shelves Process for products that are considered “hazardous waste”

21. Removal of Recalled Product Execution at Retail Source: “Industry Wide Challenges with Recall Effectiveness,” Solutions Designs, January 2011

22. Improving Effectiveness of Recalls Source: “Industry Wide Challenges with Recall Effectiveness,” Solutions Designs, January 2011

23. Recall Effectiveness - Unsaleables • How effective are we in controlling recalled products in the flow of Unsaleable products?

24. Recalls Involving Hazardous Waste

25. Be Prepared to Meet NEW Challenges in Managing Unsaleables Gale@galeprince.com 513-236-6264

26. Retail Hazardous Waste Current Regulatory Climate

27. Fines are Increasing • Since 2005, state and federal agencies have fined the retail industry over $110 million for not properly storing, transporting, or disposing their hazardous waste • The results of on-going investigations could lead to fines exceeding $250 million in fines over the next two years

28. Retail is an Enforcement Target • Retailers do fall under RCRA regulations • All retailers do generate hazardous waste • All retailers need to have a compliance program in place

29. Fines Have Increased Significantly Projected

30. The Cost of Non-Compliance

31. Retail Hazardous Waste Myths

32. “We don’t generate hazardous waste.” • Retailers fall under RCRA enforcement • If you market or use chemically-based products, you will generate some hazardous waste

33. “We send our unsaleable product back to our DC where waste determinations are made.” • Broken or leaking products are waste • Hazardous waste transporter must be used to transport directly to an approved TSDF for disposition • ORM-D packaging is most likely no longer intact • DOT training is required to properly repackage

34. “We are a CESQG, therefore the regulations do not apply to us.” Waste characterization must be performed where the waste is generated State and local restrictions may come into play Putting hazardous items in dumpster is not safe

35. Retail Hazardous Waste Real World Data

36. Important Factors Affecting Hazardous Waste Generation • The state(s) you do business in • The product lines you carry • Your industry segment

37. National Grocery Chain

38. Regional Grocery Chain in CA

39. Hazardous Waste Program Critical Components

40. Important Factors to Consider Hazardous waste minimization In store training Space constraints Frequency of service visits Availability of on-line information

41. Hazardous Waste Minimization • Can items be donated • Can items be salvaged • Are all items hazardous

42. In-Store Training • Training required to reduce the gap between intent & execution • Three choices • Train employees how to characterize waste • Use technology to minimize employee decision making • Use a third party to characterize waste

43. Space Constraints • Retailers have limited space • What is the optimum size container • Safe segregation must be maintained

44. Frequency of Service Visits • A function of: • Quantity of waste generated (generator status) • Space allocation • Accumulation tolerance • Minimum annual service recommended (regulations permitting)

45. Availability of On-line Information • Critical for hazardous waste generators that have locations • Accurate, timely data that is readily retrievable is the number one safeguard for preventing or minimizing fines

46. Availability of on-Line Data • Other Benefits • Ability to quickly respond to training needs • Streamlines State and Federal reporting • Helps indentify problems with certain product lines

47. Impact on Reverse Logistics Including Product Recalls

48. Impact on Reverse Logistics Hazardous waste may be inadvertently being transported on fleet trucks, jeopardizing DOT compliance DC or RC generator status may be impacted DC’s and RC’s are targeted by regulators Inadvertent “waste laundering” to salvagers

49. Recalls Involving Hazardous Waste

50. Conclusions Active regulatory environment Many benefits to compliance Retailers do generate hazardous waste Not managing hazardous waste properly can impact reverse logistics Retailers need a compliance program in place