1. No category

HOW TO
HANDLE
PRODUCTS
POST RECALL:
TO KEEP OR
NOT TO KEEP
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Speakers:
Corey L. Gordon, Esq., Blackwell Burke P.A.,
Minneapolis, Minnesota
Tony Jones, Ph.D., Environ International Corp.,
Irvine, California
John Marburger, Modern Foods,
Peru, Indiana
Alyssa L. Rebensdorf, Esq., Blackwell Burke P.A.,
Minneapolis, Minnesota
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Industry, Public Health and
Safety, and Spoliation:
How to Protect Your Good
Name
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FDA, USDA ,
and Other Agencies:
Recall Regulations and
Guidance
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FDA Regulations
Title 21, Part 7, revised April 1, 2008
Regulates all food except meat, poultry,
and some egg products.
 Ensures safety of drugs, biological
products, medical devices, and animal
drugs and feed.
 Regulates cosmetic, medical and
consumer products emitting radiation


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FDA Regulations

FDA Recall Classifications
–
–
–
Class I …reasonable probability that the use,
or exposure to, a violative product will cause
serious health consequences or death;
death;
Class II … use of or exposure to, a violative
product may cause temporary or medical
reversible adverse health consequences…
consequences…;
and
Class III …use of, or exposure to, a violative
product is not likely to cause adverse health
consequences.
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FDA Recall Process
 Voluntary recall
 FDAFDA-requested
 FDAFDA-initiated
recall
court action
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Reportable Food Registry
What is the FDA’s “Reportable Food Registry”?
 Part of the FDAAA of 2007 that amends the FFD&CA
 Title X (Food Safety), Section 1005 mandates the creation
of the Reportable Food Registry (“RFR”)
 Mandate to FDA: Establish a RFR, to which instances of
reportable food may be submitted via an electronic portal
and a unique number issued to the person submitting the
report upon receipt.
A “Responsible Party”
Party” is required to submit a report of
reportable food to the RFR.
 The effective date of the electronic portal was September
8, 2009.
 Industry compliance is mandatory as of that date.
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Reportable Food Registry
What is a “reportable food”
food”?
 An article of food (other than dietary supplements and
infant formula), which has a reasonable probability of
causing serious adverse health consequences or death to
humans or animals
Who is a “responsible party”
party”?
 Facilities, foreign or domestic, that manufacture, process,
pack, or hold food for human or animal consumption in the
U.S.
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Reportable Food Registry
Responsible party’
party’s responsibility






Investigate the cause of the reportable food if it may have originated
originated
with you
Make a report as soon as practical, but no later than 24 hours after a
responsible party determines that an article of food is a reportable
reportable
food.
Work with FDA authorities to follow up as necessary
May need to provide notification to immediate prior sources and
immediate recipients of food
Maintain records of report submitted and notifications made to FDA
FDA
for 2 years
NOTE: Not reporting a reportable food is a “prohibited act”
act” under
FFD&C. It is a felony.
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USDA Regulations:
Food Safety and Inspection
Service (FSIS)
 FSIS regulates
meat, poultry and processed egg
products in federally inspected plantsplantsDirective 8080.1 rev 5
 Recall classification levels similar to FDA
 Multiple recall levels, wholesale, retail, HRI,
consumer
 Recall process comparable to FDA, i.e.,
Voluntary recall, FSISFSIS-requested recall or
FSISFSIS-initiated court action
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Other Agencies:
Consumer Product Safety
Commission
 Consumer
Product Safety Improvement Act of
2008
 Regulates consumer and children’
children’s products
 Recall classification
– Voluntary recalls;
– Involuntary (CPSC(CPSC-initiated request) recalls;
– Prohibition of sale of hazardous substances
– Class II
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Public Health and Safety:
The Impetus to Destroy Product
“We don’
don’t state we want it destroyed.
We just want everyone to ‘do the right thing.’”
thing.’”
- Observation of an FDA official
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Public Health and Safety:
Product Theft
 “FDA reports health problems with stolen insulin”
insulin”
- Associated Press, Aug. 6, 2009
 “Recalled Hershey's candy being sold in Toronto
area”
area”
- CBC/Radio Canada, Oct. 30, 2008
 “American Fresh Foods Asks Consumers Not to
Purchase Its Stolen Ground Beef”
Beef”
- Red Orbit, Dec. 31, 2007
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Public Health and Safety:
Product Spoilage
What is Spoilage
 Impair value or quality, ruin or
become unfit for consumption
– Consumer products;
– Food and drinks; and
– Industrial products.
 Microbial origins; bacteria, fungi
(mold, yeast) and algae
 Public Health and Safety Impacts
– Mild symptoms of illness;
– Industrial failures; and
– Human and animal mortality.
http://www.dieselsolutions.co.nz/testimonials.shtml
http://www.sciencemuseum.org.uk/antenna/spacebacteria/
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Public Health and Safety:
Product Spoilage
How does it happen
Key requirements for optimal microbial
growth
– Moderate temperature (40F to 140F);
– Nutrients (water, carbon source); and
– pH between 6.5 and 7.5 (bacteria)
 Failure in Control Technologies
– UV or ionizing radiation;
– Chemical preservatives (sodium
benzoate, nitrites, salt, vinegar,
arsenic); and
– Pressure, antibiotics, inert gasses,
temperature

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Spoliation Legal Nuts and Bolts:
The Impetus to NOT Destroy Product
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Spoliation: Legal Nuts and Bolts
What is product spoliation?
The destruction, loss, or significant or meaningful
alteration of the product.
In the legal context, spoliation of product can be considered
an obstruction of justice, putting the spoliator at risk of
sanctions.
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Spoliation: Legal Nuts and Bolts
Factors generally considered by courts when a
party seeks spoliation sanctions
1. The existence of a pending or current civil action;
2. The alleged spoliator knew or should have known of
such action;
3. A duty to preserve evidence existed;
4. Actual spoliation occurred;
5. The culpability of the offender (i.e., the alleged mental
state);
6. The spoliated evidence was material to the case;
7. The degree of prejudice or harm which resulted from the
spoliation.
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Spoliation: Legal Nuts and Bolts
Intentional destruction vs. willful interference:
A question of bad faith?
There is a general rule that if a party intentionally destroys
evidence that is relevant to a case, a presumption arises that the
the
evidence would have been adverse to that party's case. However,
this adverse presumption arises only when the complaining party
can establish "'intentional conduct indicating fraud and a desire
desire to
destroy [evidence] and thereby suppress the truth.'"
Ward v Consolidated Rail Corp,
Corp, 472 Mich. 77, 84; 693 N.W.2d 36 (2005),
(2005),
quoting Trupiano v Cully,
Cully, 349 Mich. 568, 570; 84 N.W.2d 747 (1957).
(1957).
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Spoliation: Legal Nuts and Bolts
In some jurisdictions, a finding that a litigant acted
in bad faith is NOT required.
Spoliation encompasses both intentional and negligent
destruction of evidence. Patton v. Newmar Corp.,
Corp., 538 N.W.2d
116, 118 (Minn. 1995);
1995); Himes v. WoodingsWoodings-Verona Tool Works,
Inc.,
Inc., 565 N.W.2d 469, 471 (Minn. App. 1997),
1997), review
denied (Minn. Aug. 26, 1997) (noting that spoliation sanction does
not imply any wrongdoing on spoliator's behalf). Regardless of
intent, disposal of evidence is spoliation when a party knows or
should know that the evidence should be preserved for pending or
future litigation. Patton,
Patton, 538 N.W.2d at 118.
118.
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Spoliation: Legal Nuts and Bolts
Sanctions available

Adverse inference – jury may presume that the evidence
was unfavorable to the spoliator

Outright dismissal of claims or defenses

Separate tort action in some jurisdictions

Criminal sanctions
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How Much is Enough:
Designing a Sound Sampling and
Preservation Plan
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How Much is Enough:
Designing a Sound Sampling and
Preservation Plan
Sampling Plans
 Environmental and Lot Acceptance Sampling Plans
 Environmental Sampling Plans include Good Hygienic
Practices (GHP), Good Commercial Practice (GCP) and Hazard
Analysis and Critical Control Point Principles (HACCP)
 GHP, GCP and HACCP are prevention tools.
 Effectiveness of sampling plan dependent on:
- Detecting a problem; and
- Responding to a problem once detected.
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How Much is Enough:
Designing a Sound Sampling and
Preservation Plan
Lot Acceptance Plans
• No standard protocols, statistical procedures based on type of food, size, extent of
acceptable levels of microorganisms, and degree of confidenceconfidence-ICMFS 2002;
•Based on Food Safety Objectives (FSO), Performance Objective PO) and Microbiological
Criteria (MC)
From ICMSF. 2006. A simplified Guide to Understanding and Using Food
Safety Objectives and Performance Objectives
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How Much is Enough:
Designing a Sound Sampling and
Preservation Plan
Good Resources
 AOAC International. http://www.aoac.org/testkits/testedmethods.html
Hazard Analysis and Critical Control Point Principles and Application
Guidelines. 1997. FDA (www.fda.gov/food/foodsafety/);
ICMSF. 2006. A simplified guide to understanding and using food safety
objectives and performance objectives
 Kuneja and Sofos. 2009. Pathogens and Toxins in Foods: Challenges and
Interventions.;
 ICMFS. 2002. Microorganisms in Foods 7 Microbiological testing in food safety
management;
 Tompkin, R. B. 2004. Environmental sampling – A tool to verify the
effectiveness of preventative hygiene measures. Mitt. Lebensesm., Hyg. 95, 45-51.
USDA and FDA;
 World Health Organization, 2003. Hazard Characterization for pathogens in
Food and Water-Guidelines.
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Tips When Destroying Product or
Moving Product to Storage
 Contact agency officials prior to destruction to
confirm if agency wants to witness destruction
- Guidance for Industry: Product Recalls, Including Removals and
Corrections. 2003. FDA (www.fda.gov/safety/recalls/industryguidance)
 Implement strict anti-theft protocols
Keep adequate documentation of product
destruction
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Summary and Questions:
A Protocol for
Effective Product Destruction
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