Hazardous Material Transportation
Gale Prince, SAGE ConsultingTom Carney, Stericycle ExpertSUSTAINABILITY
Erica Fransen, SuperValu
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
Food Safety Modernization Act2010
July 20, 2011Gale Prince
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
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
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)
• 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”
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
Improving Capacity To Prevent Food Safety Problems
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
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
Improving Capacity To Prevent Food Safety Problems
• Sec 111. Sanitary Food Transportation of Food• Shall promulgate regulations on sanitary food transportation (18
months)
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”
• 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
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
Improving Capacity To Detect and Respond to Food Safety Problems
FDA Food Recall Trends
From 2007 to 2009, FDA Food Recalls increased almost 400%
2004 2005 2006 2007 2008 2009 20100
500
1000
1500
2000
2500
3000
Source: Comprehensive Recall Data Analysis 2010
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.
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
Alignment between Retailer and Manufacturer
• Removing Recalled Product from retail store shelves• Process for products that are considered “hazardous waste”
Removal of Recalled Product Execution at Retail
Source: “Industry Wide Challenges with Recall Effectiveness,” Solutions Designs, January 2011
Improving Effectiveness of Recalls
Source: “Industry Wide Challenges with Recall Effectiveness,” Solutions Designs, January 2011
Recall Effectiveness - Unsaleables
• How effective are we in controlling recalled products in the flow of Unsaleable products?
Be Prepared to Meet NEW Challenges in Managing
[email protected] 513-236-6264
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
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
The Cost of Non-Compliance
Type of Retailer EPA or State Fine# of stores involved
Average Fine – Cost per Store
Big Box Retailer A $22 125 $176k/store
Big Box Retailer B $28.5 205 $139k/store
Big Box Retailer C $8.6 98 $87k/store
Home Improvement
$10 250 $40k/store
Regional Grocery $.4 230 $1700/store
“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
“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
“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
Important Factors Affecting Hazardous Waste Generation
• The state(s) you do business in• The product lines you carry• Your industry segment
National Grocery Chain
Number of Stores 3200
Avg lbs per pick up 38
Different waste stream 16
SOP discrepancy rate 29.7 %
Number of stops per year 2
Regional Grocery Chain in CA
Number of Stores 230
Avg lbs per pick up 77
Different waste stream 14
SOP discrepancy rate 9.7 %
Number of stops per year 2
Important Factors to Consider
• Hazardous waste minimization
• In store training
• Space constraints
• Frequency of service visits
• Availability of on-line information
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
Space Constraints
• Retailers have limited space• What is the optimum size container• Safe segregation must be maintained
Frequency of Service Visits
• A function of:• Quantity of waste generated (generator status)• Space allocation
• Accumulation tolerance• Minimum annual service recommended (regulations permitting)
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
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
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
Recalls Involving Hazardous WasteRecall Product Containing Hazardous Waste
Selected States (e.g., CA)
Product may have a Waste Code such that the waste is treated as Hazardous Waste in the stateSolution: Option 1 (Disposal)1. Retrieval Rep:
a. On-site EC’s / Verify removal from shelvesb. Document Inventory
c. Complete necessary paperwork2. Hazardous Waste disposal / pick-up / destruction
Solution: Option 2 (Sustainable)1. Retrieval Rep:
a. On-site EC’s / Verify removal from shelvesb. Document Inventory
c. Complete necessary paperworkd. Ship for recycling
2. Recycling for Ethanol Recovery
Selected StatesProduct is NOT considered Hazardous Waste Solution:
1. Retrieval Rep:a. On-site EC’s / Verify removal from shelves
b. Document Inventory c. Complete necessary paperwork
2. Destruction Options:a. Destroy in the field
b. Send to Company for destruction, recycle, or alternate use