Jennifer McEntire, Ph.D.jmcentire@gmaonline.org

202-639-5970

Recall readiness, execution and

communication

*Represents a sample of GMA members

GMA Member Companies

General Members

Associate Members

Overview

• Recalls and you

• Recall preparation

Legal requirements vs best in class

• Recall execution

Real life vs mock recalls

• Communication

Internal

External

Case studies

Outside of Scope

• Legal aspects of a recall

Go to Shawn Stevens’ session tomorrow at 11:30

Question

How many of you grow, harvest, pack, process,

manufacture, store or distribute food?

Have you ever been involved in a recall?

If not, what is the likelihood that you might be in the next 5

years?

Do you have recall insurance?

2014 USDA recallsRecall Summary for Calendar Year 2014

Total

Number of

Recalls

Number of

Pounds

Recalled

94 18,675,102

Recalls by Class (N=94)

Class I 63 14,261,888

II 23 3,817,387

III 8 595,827

Recall by Species/Product (N=94)

Species Beef 22 13,232,176

Mixed 14 2,151,495

Pork 26 1,032,582

Poultry*** 31 2,230,901

Ovine 1 27,948

http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-summaries

USDA notable recalls Recalls by Reason (N=94)Reason For

RecallSTEC* 5 1,840,533

Listeria

monocytoge

nes

7 270,926

Salmonella 4 372,414

Undeclared

Allergen43 6,147,288

Extraneous

Material6 265,607

Processing

Defect4 59,203

Undeclared

Substance2 80,084

Other** 23 9,639,047

• 8.7 m lb beef- lack

of inspection

• 1.8 m lb gr beef E.

coli contamination

FDA regulated food products

• >400 recalls in 2014

Table 1: Comparison of Years 1, 2, 3 and 4 RFR

Total Submissions and Entries Report Category

Year 1 Year 2 Year 3 Year 4

Total Entries 2240 882 1095 1269

Primary (Industry and Voluntary) Entries

229 225 224 202

Subsequent Entries (Upstream and Downstream)

1872 483 609 849

Even if you didn’t

cause the issue,

it can still impact

you!

Future Recall Trends

• More recalls

Science and epidemiology continues to get better

Whole Genome Sequencing

Media continue to focus on food issues

There will be more “recall-able” events due to more regulations- the “bar” to recall a product may be lower

Supplier control

Allergens/ gluten

Heavy metals

Long term health consequences

This does not mean food will be less safe!!!

What it does mean

Be prepared!

Have a recall plan

Know how to use it

Make sure it works in real life

What MUST a

recall plan address

(USDA)?• How the establishment

will decide whether to recall the product

• How to effect the recall

• Consider

• Recall team

• Scope

• Records

• Communication

• Public notification

• Effectiveness checks

• Disposition

• Recall simulations

Proposed FDA recall

plan requirements

• Directly notify

consignees

• How to dispose of

the food

• Notify the public

• Effectiveness

checks

• Notifying FDA of a

reportable food

• No current proposed

mock recall

requirements

Recall Plan Ingredients

• Recall Team identification

• Decision making process/ roles

and responsibilities

• Templates

Press releases

FAQs

Customer letters

Agency communications

• Checklists

Recall action items

Meeting logs

• Contact lists (up to date!!)

Internal

External

Govt contacts

Insurance company

Laboratory

Attorney

PR firm

Call center

What else?

• WHO

Leadership

Internal & external

resources

Roles & responsibilities

• HOW

Incident evaluation

Customer knowledge

• WHAT

Records

Systems

Communications

Recall Plan Offshoots

• Traceability– your traceability program is not your recall

plan!

• Regulatory inspection policy

Do you allow photographs?

Do you take duplicate samples?

Traceback vs recallTraceback Recall

Regulator –driven Industry-driven

Supply chain wide 1 forward/back

Scope of issue unknown Known issue

Trying to find common source Locating known product

Hard to determine Easy to test

The steps of a recall

1. Notification of a potential issue

2. Health hazard evaluation, scope determination

3. Recall?? Strategy

4. Execution

5. Termination

1. How will you know?

• Government Authorities

Tested product, outbreak investigation

• Media

• Malicious threat

Food defense issues are different

• Consumer/ Customer complaints

What is critical vs not?

How are they tracked and escalated?

• Internal discovery

• Supplier notification

Foreign Objects: “I found

something that should not

have been in my product!”

- Might involve an injury

(usually a dental or mouth injury)

Illness Claims: “Your

product made me sick!”

- Typically last product used

before illness symptoms surfaced

- Often consumer noticed

off-flavor, but ate/drank product

anyways

Defective Containers: “I

hurt myself opening your

product!” or “Your product

leaked and caused

property damage!”

2. Is it dangerous?

• Health hazard evaluation Likelihood and severity

Description of the issue

Number of complaints/ # ill or injured

Short and/or long term health consequences given the level of the hazard

At-risk populations

Public health impact

L. monocytogenes on an apple vs pesticide residue above legal limit on an apple

Do you recall?

• Regulatory violation

• Public health risk

• Brand risk

• Even if you don’t recall, it doesn’t mean the issue is over

Do you recall?

Make the decision before hand!

Anticipate the types of contaminants/ levels/

situations

Sketch out how various situations would be

handled

Have them pre-approved

Takes the pressure off, reduces uncertainty

and confusion, and saves time in a real event

Scope

• How do you know when the issue occurred?

• How do you know you’ve fixed the problem?

Records:

• Production logs

• Sanitation logs

• Maintenance records

• Pre-op inspection forms

• Test results

Real Life #1

Company A ships a RTE product to a co-man for Company B. The co-man chops/crumbles and repackages.

Finished product testing found the product was positive for non-pathogenic Listeria species.

Is this a problem?

Questions:

Did they test incoming product?

Did they have a strong environmental monitoring program?

How do you determine scope?

Does the product support growth?

Later found LM in zone 3

$200K product

Go to

Warren

Stone’s

session

3. Recall strategy

• It depends!

• What happened?

• What is the health risk?

• How much product was impacted, and where is it now?

• Messaging to communicate these issues

• Who makes the decision on the recall strategy?

• (and to reiterate, better to think through “likely” situations in

advance)

Real Life #2

Company J sends ingredients to co-man that are labeled with a “may contain” allergen statement

Company J is an approved supplier of “The Brand”. “The Brand” has audited Company J and found their allergen control to be exceptional. So they don’t have a “may contain” statement on their product,

being produced by the co-man

One day the co-man tested the ingredient. It was positive for an allergen. The Brand also tested the ingredient. It was negative for the allergen. Finished product was already in distribution

Is a recall needed? Who decides?

End result: recall announced 3.5 weeks later

Handling Recalled Product

Based on the hazard, amount of product, practical considerations including cost

• Destroy/ denature in the field (need proof)

• Ship to central location for reconciliation

• Re-label, rework, etc

• Who will be responsible?

• How will you verify these actions were taken?

• What if it’s a food defense issue?

4. Execution: pulling the

trigger

• Clear roles and responsibilities

• Clear decision making process

• Accurate and timely communications

• Great documentation

5. Termination

• Documentation is complete

• Effectiveness is verified

• Root cause is identified

Corrective actions in place

• Consumers are safe- product is out of the market

• Internal after action assessment is complete

Communication

"The two words information and communication are often used interchangeably, but they signify quite different things.

Information is giving out; communication is getting through."

- Sydney Harris

Communicating during a

crisis Your

employees

Regulators

Media

The publicCustomers

Shareholders

Questions

Is anyone the spokesperson for their company?

Has anyone had media training?

Does anyone have a neighbor?

Communication 101

• Communicate BEFORE

Establish relationships

Promote an understanding of the process

• Communicate DURING

What you know

What you don’t know

What you’re doing to find out

When you’ll be back in touch

• Communicate AFTER

What you’ve done to ensure it won’t happen again

Food Safety Landmarks

• 1982 Tylenol

• 1996 Apple juice

• 2006 Spinach

• 2009 PCA peanut products

• 2011 Cantaloupe

• 2014 Foster Farms

1982 Tylenol

• 7 deaths- cyanide

• J&J was a victim

Offered a reward

• Tamper evident packaging

1996 Apple Juice

• One child died; 60 people sickened with E. coli O157:H7

• > 20 personal injury lawsuits

• Stock price dropped 34%

• 90% reduction in sales

• Recall- direct costs $6.5 M

• Criminal fine $1.5 M

• Flash pasteurization

• “Best Brand Name in the Bay Area” one year later by San Francisco Magazine

2006 Spinach

• 3 deaths, 205 ill w E. coli O157:H7

• “Natural Selections” brand sales fell 30%

• 1 year later industry sales were at 85% of pre-outbreak

levels

• Earthbound Farm

Led industry best practice leafy greens marketing

agreement and more

Very visible food safety person

2009 PCA

9 deaths, 714 ill; Salmonella

Knowingly released contaminated product

4 company officials charged

Feb 2009 filed for bankruptcy

2011 Jensen Farms

Cantaloupe

30 deaths, 146 cases Listeria monocytogenes

Very poor food safety practices

2012 filed for bankruptcy

Owners pled guilty to criminal charges

But sued the auditor for giving a good rating

2014 Foster Farms

2 Salmonella outbreaks

March 2013-July 2014

Almost 650 people confirmed ill

Recall issued July 3, 2014

Salmonella is not an adulterant; no regulatory violation

Keys to Survival

• Do the right thing

• Even when people aren’t looking

• Easier to forgive the “good guys”

• Put a face to your food safety efforts

• Communicate, communicate, communicate

Show compassion and concern

Most people aren’t scientists

Logic, facts, and regulations don’t matter

• Acknowledge shortcomings and demonstrate leadership and improvement

Conclusion

• Recalls will continue to happen

• Outbreaks will continue to happen

• Do all you can to avoid this!

• Be prepared for it to happen

• You determine the fate of your company

Thank you!

Questions?

44