Food Recalls Essentials for Action

Presented By California Department of Public Heath

Food and Drug Branch

Phone (916) 650-6500 Fax (916) 650-6650 FDBtrainingcdphcagov

3

4

1

5

1

3

7

1

4

0

2015

1

2017

Training Agenda

I Food Safety Law and Regulatory Agencies

II Essential Elements of a Recall Action Plan

III Mock Recall Exercise

IV Resources

California Law Sherman Food Drug and Cosmetic Act

The Sherman Food Drug and Cosmetic Act is the state law that prohibits the manufacture or

sale of food that is adulterated misbranded falsely advertised or misleading

Text of the Sherman Law can be found at httpwwwcdphcagovservicesDocumentsfdbSFDCApdf

Adulteration (Health and Safety Code Sections 110545-110610)

Ways that food can become contaminated or ldquoadulteratedrdquo

Physical Glass ndash jars bottles light fixtures thermometers Metal ndash machinery wire staples Plastic - packaging materials Stones- from plant surroundings Wood ndash boxes bins pallets

Chemical Chemical adulteration includes pesticides cleaners and paint toxic elements such as lead or mercury

Biological Viruses or bacteria from food-borne pathogens (ie Salmonella E coli 0157H7 Hepatitis A)

2

2017

Misbranding THE WHEREBY CLAUSE(Health and Safety Code Section 110660)

Requires that all packaged foods list specific information on labels to avoid misbranding due to false misleading or missing information

Food labels must include Food Name Responsible Firm Address (if not listed in local Yellow Pages) Ingredient Listing (in order of predominance by weight) Net Quantity

Allergen Labeling Law FALCPA

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) applies to all foods labeled on or after January 1 2006

Food labels must list the food source names of all ingredients that contain any protein derived from the eight most common food allergens which FALCPA defines as ldquomajor food allergensrdquo

FALCPA Major Allergens

Eight foods are designated as major food allergens by FALCPA

bull Milk bull Eggs bull Fish (eg bass flounder cod) bull Crustacean shellfish (eg crab lobster shrimp) bull Tree nuts (eg almonds walnuts pecans) bull Peanuts bull Wheat bull Soy

3

2017

Bioterrorism Registration

To protect the public from a threat or actual terrorist attack on the nationrsquos food supply the Public Health Security and Bioterrorism Preparedness Response Act requires food facilities to register with the FDA

Register at wwwfdagov

FSMA Main Themes of the Law

Prevention

Inspections Enhanced Compliance

Partnerships and Response

Import Safety

Proposed Rules

Preventative Controls for Human Food 83015

Preventative Controls for Animal Food 83015

Produce Safety Standards 103115

Foreign Supplier Verification Program 103115

Accreditation of Third Party Auditors 103115

Sanitary Transportation 33116

Intentional Adulteration 53116

4

2017

Bioterrorism Registration

To protect the public from a threat or actual terrorist attack on the nationrsquos food supply the Public Health Security and Bioterrorism Preparedness Response Act requires food facilities to register with the FDA

Register at wwwfdagov

FSMA Main Themes of the Law

Prevention

Inspections Enhanced Compliance

Partnerships and Response

Import Safety

Proposed Rules

Preventative Controls for Human Food 83015

Preventative Controls for Animal Food 83015

Produce Safety Standards 103115

Foreign Supplier Verification Program 103115

Accreditation of Third Party Auditors 103115

Sanitary Transportation 33116

Intentional Adulteration 53116

4

2017

Food Safety Modernization Act

Check the FDA website at wwwfdagovfsma for information on FSMA

A subscription service for updates is available Contact FSMAfdahhsgov

General Foods

Fresh Produce

Meat amp Poultry

Disease Investigation

Removal of Products fromCommerce

5

2017

Removal of Products from Commerce

Stock Recovery

Market Withdrawal

Recalls

Recalls

Class I Class II Class III

2017

RECALL ACTION PLAN Essential Plan Elements

1 ASSIGN roles and responsibilities

2 EVALUATE the hazard

3 IDENTIFY product and scope

4 NOTIFY affected parties

5 REMOVE affected product

6

2017

RECALL ACTION PLAN Essential Plan Elements

1 ASSIGN roles and responsibilities

2

3

4

5

RECALL ACTION PLAN Recall Team

Management

DistributionSales

ProductionPurchasing

Quality Assurance

Recall Coordinator

RECALL ACTION PLAN Support Personnel

Accounting Information Technology

Customer Service Scientific Support

Public Relations Records Management

Legal Regulatory Affairs

7

RECALL ACTION PLAN Essential Plan Elements

1

3

2 EVALUATE the hazard

4

5

ComplaintCondition Evaluation Flow

Chart

Is there a PROBLEM

8

2017

RECALL ACTION PLAN

2 Evaluate the hazard

Is it MY problem

RECALL ACTION PLAN Preparation 2 Evaluate the hazard

How is my problem bad

Recalls

How much

information is enough

9

2017

RECALL ACTION PLAN Essential Plan Elements

3 IDENTIFY product and scope

1

2

4

5

SOURCE

PRODUCT(S)

LOCATION

REPORTABLE FOOD REGISTRY

httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm

10

2017

2017

RECALL ACTION PLAN Essential Plan Elements

1 ASSIGN roles and responsibilities

2

3

4

5

RECALL ACTION PLAN Recall Team

Management

DistributionSales

ProductionPurchasing

Quality Assurance

Recall Coordinator

RECALL ACTION PLAN Support Personnel

Accounting Information Technology

Customer Service Scientific Support

Public Relations Records Management

Legal Regulatory Affairs

7

RECALL ACTION PLAN Essential Plan Elements

1

3

2 EVALUATE the hazard

4

5

ComplaintCondition Evaluation Flow

Chart

Is there a PROBLEM

8

2017

RECALL ACTION PLAN

2 Evaluate the hazard

Is it MY problem

RECALL ACTION PLAN Preparation 2 Evaluate the hazard

How is my problem bad

Recalls

How much

information is enough

9

2017

RECALL ACTION PLAN Essential Plan Elements

3 IDENTIFY product and scope

1

2

4

5

SOURCE

PRODUCT(S)

LOCATION

REPORTABLE FOOD REGISTRY

httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm

10

2017

RECALL ACTION PLAN Essential Plan Elements

1

3

2 EVALUATE the hazard

4

5

ComplaintCondition Evaluation Flow

Chart

Is there a PROBLEM

8

2017

RECALL ACTION PLAN

2 Evaluate the hazard

Is it MY problem

RECALL ACTION PLAN Preparation 2 Evaluate the hazard

How is my problem bad

Recalls

How much

information is enough

9

2017

RECALL ACTION PLAN Essential Plan Elements

3 IDENTIFY product and scope

1

2

4

5

SOURCE

PRODUCT(S)

LOCATION

REPORTABLE FOOD REGISTRY

httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm

10

2017

RECALL ACTION PLAN

2 Evaluate the hazard

Is it MY problem

RECALL ACTION PLAN Preparation 2 Evaluate the hazard

How is my problem bad

Recalls

How much

information is enough

9

2017

RECALL ACTION PLAN Essential Plan Elements

3 IDENTIFY product and scope

1

2

4

5

SOURCE

PRODUCT(S)

LOCATION

REPORTABLE FOOD REGISTRY

httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm

10

2017

RECALL ACTION PLAN Essential Plan Elements

3 IDENTIFY product and scope

1

2

4

5

SOURCE

PRODUCT(S)

LOCATION

REPORTABLE FOOD REGISTRY

httpwwwfdagovFoodComplianceEnforcementRFRdefaulthtm

10

2017

2017

RECALL ACTION PLAN Essential Plan Elements

1

3

2

4 NOTIFY affected parties

5

Recall Notice

Press Release

11

URGENHeader T FOOD RECALL

Firm Contact Information and Date

National RecalSt

l of Naturersquoatement

s Nest of

Brand Recall

YUMMY YUCKIES

ABC Company nc Date TodayCalifornia CA1-800-123-4567

APBC

r Co

Od ofu

Cc

atlifio

ornnia CIn

Af ois rr

emcalling

atio6 ouncn ndash

e cPontr

aoineb

rs le

of Naturersquom ndash S

s Nest top

Brand Sal

Yeum S

myt Yautckie

esrdquom

cerealent

cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the

affected product

illnesses have been Detailed P

reported iroduct

n connect Inf

ion ormat

with thisi product on ndash

and no other NaStatement

turersquo sof Nest products are

by affect

the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co

YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013

request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB

rC Direct

Co will arrange ives

for shipping to our plant in CaliforniaCA

C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have

records regardior

ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely

Request be requested

r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567

STh

tank y

anou

dafo

rr

dyour

S Ccooperat

losi

ron

incerely u e

be s

No ed

Yuc de

We or an o re

AB be c

You ve

Company President

Donrsquot Be THAT Guy

RECALL ACTION PLAN Essential Plan Elements

1

3

2

4

5 REMOVE affected product

12

2017

2017

REMOVAL

RECONCILIATION

EFFECTIVENESS

DISPOSITION

TERMINATION

RECALL ACTION PLAN Essential Plan Elements

1 ASSIGN roles and responsibilities

3 IDENTIFY product and scope

2 EVALUATE the hazard

4 NOTIFY affected parties

5 REMOVE affected product

4 Hours

13

Recall Coordinator Resources

Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you

bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx

bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm

Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution

Requested Documents

Affected Product

Product Information

Labels

Draft Recall Notices

Draft Press Releases

Requested Documents

Amount of Product Made or Received

Amount Distributed

Distribution List

14

2017

URGENHeader T FOOD RECALL

Firm Contact Information and Date

National RecalSt

l of Naturersquoatement

s Nest of

Brand Recall

YUMMY YUCKIES

ABC Company nc Date TodayCalifornia CA1-800-123-4567

APBC

r Co

Od ofu

Cc

atlifio

ornnia CIn

Af ois rr

emcalling

atio6 ouncn ndash

e cPontr

aoineb

rs le

of Naturersquom ndash S

s Nest top

Brand Sal

Yeum S

myt Yautckie

esrdquom

cerealent

cause they may have been contaminated with Salmonella Salmonella can cause serious illness in individualif consumed ABC Co requests that you to immediately cease all sales and distribution and segregate the

affected product

illnesses have been Detailed P

reported iroduct

n connect Inf

ion ormat

with thisi product on ndash

and no other NaStatement

turersquo sof Nest products are

by affect

the recall Illnesses kies are sold 12 ndash 6 oz boxes per case labeled under the Yummy Yuckiesrdquo brand and identified with the co

YUCK123rdquo that is printed in black letters on the top of the case The affected product was manufactured anddistributed from May through August 2013

request that you notify your customers and provide them with this notice if they have received this product y product processed by your firm Consumethat contains the affected Yuckies as an ingredient Direct your accounts ttrieve the product and return to your facility The AB

rC Direct

Co will arrange ives

for shipping to our plant in CaliforniaCA

C Co has notified the appropriate federal and state health authorities about the recall These agencies may ontacting yRegulatou to confirm that yy Notou have

records regardior

ng the receiifireceicatved thiion sand I notice and are comnformatplyiing on with our requests Your firm pt and distribution of the products will likely

Request be requested

r prompt attention to this recalFirm Col will assist ABnC tCoa cint In remofoving the rmaproduct tion from the marketplace If you haany questions or concerns please contact or recall coordinator John Smith at 1-800-123-4567

STh

tank y

anou

dafo

rr

dyour

S Ccooperat

losi

ron

incerely u e

be s

No ed

Yuc de

We or an o re

AB be c

You ve

Company President

Donrsquot Be THAT Guy

RECALL ACTION PLAN Essential Plan Elements

1

3

2

4

5 REMOVE affected product

12

2017

2017

REMOVAL

RECONCILIATION

EFFECTIVENESS

DISPOSITION

TERMINATION

RECALL ACTION PLAN Essential Plan Elements

1 ASSIGN roles and responsibilities

3 IDENTIFY product and scope

2 EVALUATE the hazard

4 NOTIFY affected parties

5 REMOVE affected product

4 Hours

13

Recall Coordinator Resources

Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you

bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx

bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm

Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution

Requested Documents

Affected Product

Product Information

Labels

Draft Recall Notices

Draft Press Releases

Requested Documents

Amount of Product Made or Received

Amount Distributed

Distribution List

14

2017

2017

REMOVAL

RECONCILIATION

EFFECTIVENESS

DISPOSITION

TERMINATION

RECALL ACTION PLAN Essential Plan Elements

1 ASSIGN roles and responsibilities

3 IDENTIFY product and scope

2 EVALUATE the hazard

4 NOTIFY affected parties

5 REMOVE affected product

4 Hours

13

Recall Coordinator Resources

Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you

bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx

bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm

Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution

Requested Documents

Affected Product

Product Information

Labels

Draft Recall Notices

Draft Press Releases

Requested Documents

Amount of Product Made or Received

Amount Distributed

Distribution List

14

2017

Recall Coordinator Resources

Recall Coordinators are a useful resource in the event of a food recall To contact the recall coordinator nearest you

bull State CDPH-FDB ndash send email to fdberucdphcagov view food recalls at httpwwwcdphcagovHealthInfoPagesfdbFraspx

bull Federal US FDA - list of regional recall coordinators can be found at httpwwwfdagovSafetyRecallsIndustryGuidanceucm1293 34htm

Be prepared to advise the recall coordinator on the reason for the recall list of consignees and areas of distribution

Requested Documents

Affected Product

Product Information

Labels

Draft Recall Notices

Draft Press Releases

Requested Documents

Amount of Product Made or Received

Amount Distributed

Distribution List

14

2017

Distribution List

Distribution List

Business Type Customer May Use Product as an

Ingredient (YesNo) Customer NameAddressTelephone Contact PersonEmail Address Product Ship Date Amount of Product Shipped Lot No UPC Brand Name of Manufactured Products

Mock Recall Exercise

15

2017

2017

Resources

Follow CDPH‐FDB on Twitter CDPH_FoodAlert

16

Recovery

Recall Closure

Review of Process

Revision in Process

Reinvention

Remarketing

If You Have Questions Contact

State Government

CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500

California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)

Federal Government

US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)

US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)

Questions

2017

17

2017

Resources

Follow CDPH‐FDB on Twitter CDPH_FoodAlert

16

Recovery

Recall Closure

Review of Process

Revision in Process

Reinvention

Remarketing

If You Have Questions Contact

State Government

CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500

California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)

Federal Government

US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)

US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)

Questions

2017

17

Recovery

Recall Closure

Review of Process

Revision in Process

Reinvention

Remarketing

If You Have Questions Contact

State Government

CDPH-Food and Drug Branch PO Box 997435 MS 7602 Sacramento CA 95899-7435 E-mail FDBtrainingcdphcagov Phone (916) 650-6500

California Department of Food and Agriculture1220 N Street Sacramento California USA 95814 wwwcdfacagov Phone (916) 654-0466 (Sacramento)

Federal Government

US Food and Drug Administration10903 New Hampshire Avenue Silver Spring MD 20993 wwwfdagov Phone 1-888-INFO-FDA (1-888-463-6332)

US Department of Food and Agriculture 620 Central Avenue Building 2C Alameda CA 94501 wwwfsisusdagov Phone (510) 337-5000 (Alameda District)

Questions

2017

17