Danger! Pitfalls of converting HACCP Plans to FSMA Food ... · The Food Safety Modernization Act (FSMA) is an extensive, complex set of regulations for how food processing businesses

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Danger! Pitfalls of converting HACCP Plans to

FSMA Food Safety Plans?

Food Safety Summit 2018

Deb Kane, Director Food Safety & QA

J&J Snack Foods Corp. 1

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Program PRP – prerequisite PC – preventive control

Supply

Allergen

Sanitation

Examples of PCs outside of CCPs

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Supply • Supplier Approval Program• Review audit reports • Review food safety programs

Allergen

Sanitation


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• Supply-chain applied control (kill-step)• COA (allergen free)• LOG for potential chemical hazards

Allergen

Sanitation


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Allergen • Raw material receiving• Proper storage & cleaning spills• Color-coding for tools/utensils• Personnel practices

Sanitation


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• Ensure labels are correct – receiving • Ensure correct label or package used• Allergen changeover/rework procedures

Sanitation


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Sanitation • Facility hygiene as necessary• Cleaning operations not a source

of contamination• Waste management• SSOPs


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Sanitation • Facility hygiene as necessary• Cleaning operations not a source

of contamination• Waste management• SSOPs

• Verification of allergen removal• Verifications post-thermal (RTE products)• Corrections can be made prior to running*


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Food Safety Plans

Systematic process based on science

Specific to a facility (products may be grouped if hazards/controls are generally the same)

Preventive Controls specific to a product/process based on the HAZARD ANALYSIS conducted by the FS Team at the plant

• Allergens: where is the risk for cross-contact in the facility? Equipment, process, people?

• Supply-chain: if PC is review of the COA, needs to be managed at the plant level

• Sanitation: how easy is equipment to clean (e.g., age, condition, materials – fabric belts)?

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QUESTIONS??

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Deb Kane, J&J Snack Foods Corp.

New Jersey’s Regulatory Approach:

Preventative Controls and Limited Scope PC

Inspections

Danielle Clemons, MPH

MFRPS Coordinator

Public Health & Food Protection Program (PHFPP)

Agenda•Food Firm Inventory

•Tools of Enforcement

•Frequently Cited Violations

New Jersey’s Response to FSMA

• What did these legislative changes mean and who is required to comply?

• How do we prepare staff ?

• Do we have the RESOURCES?!?

• Where do we START!?!?!

New Jersey Food Firm InventoryRisk Typing

High Risk • Activities

- Canning, vacuum packaging, smoking

AND/OR

- Handing of foods frequently implicated in foodborne illness

AND/OR

- POOR COMPLIANCE HISTORY

• Inspection Frequency

- Every Year

OR

- Complaints

Risk Categorizing Continued

MEDIUM RISK• Activities

- cooking, cooling, holding under controlled temperatures, pasteurization

AND/OR

- potentially hazardous foods not typically implicated in foodborne illness


- Every 3 years

OR

- Complaint

Low Risk

• Activities

- Storing and handling of foods where temperature

control is not required AND/OR

- Non-potentially hazardous foods AND/OR

- ROUTINE COMPLIANCE


- Every 4 years OR Complaints

Total Manufactured Food Firms

• ~3000 total firms

• 64% Classified Low Risk Firms

• 75% firms

– small (<500 employees) or

very small (< 1 mil)

Capacity Assessment• Regulatory Authority

- New Jersey has not adopted 21 CFR 117 PC Rule

- FDA Pocket Credentials- Confers upon the recipient the authority to perform activities in designated program areas as a federal official within their own state (or local) jurisdiction.

• Staff

- 21 Full time inspectors

- 11 inspectors issued pocket credentials

- 0 State PC Inspectors/ 2 Federal PC

• Training Plan

- Required and prerequisite coursework

- Timelines

Inspections Scope & ApproachLimited Scope 110/117

• Educate before and while you Regulate!!

• Broad Based Assessment

• Ask Questions

• Document Review

Current Inspectional Data

• Issuance of 483’s

• Nationally

• New Jersey

• Data Trends

• Top Categories of Frequently Cited Violations

- Production and Processes 24%

- Sanitary Operations 24%

- Facility Procedures 18%

- Sanitary Facilities and Controls 14%

QUESTIONS

C. DANIELLE CLEMONSMFRPS COORDINATORPO BOX 369TRENTON, NJ PHONE: (609) 826-4935

Contact Information

Donna F Schaffner, 2018

Utilizing your HACCP Plan

as one component of the

“FSMA Puzzle”

Speaker: Donna F. SchaffnerAssoc Director: Food Safety, QA & Training Programs

Rutgers Food Innovation Center, Bridgeton, NJ 08302

[email protected]

Presentation for the

2018 Food Safety Summit

“Pitfalls” symposium – May 10, 2018.

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mailto:[email protected]


The FSMA Puzzle…

The Food Safety Modernization Act (FSMA) is an

extensive, complex set of regulations for how food

processing businesses must conduct innumerable

activities that might have an influence on “Food

Safety” with requirements for documentation of all

those activities.

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The FSMA Supply Chain…

Implementation of the

“Preventive Controls” rules will

have far-reaching

consequences supply chain

back to the “original grower”…

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of all goods/ ingredients used

in food production; affecting all

entities involved with the

production, transportation,

holding or storage of food.


Food Safety Modernization Act

Preventive Controls for Human Food: compliance dates: Sept. of 2016, 2017, 2018

Preventive Controls for Animal Feed:

compliance dates: Sept. of 2017, 2018, 2019

Produce Regulations:

compliance dates: Jan. of 2018, 2019, 2020

Foreign Supplier Verification Program:

compliance dates: Jan. of 2017, 2018, 2019

Sanitary Transportation of Food:

compliance dates: June of 2017 & 2018

Intentional Adulteration of Food:

compliance dates: July of 2019, 2020, 2021

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Traditional HACCP Plans…

Only concentrated on the

PROCESS while things

were inside the

processing facility.

Everything else is just a

“pre-requisite” and often

NOT subjected to nearly

the same amount of

scrutiny as the CCPs.

receiving

storage

packaging

storage

shipping

cooking

cooling

CCP

CCP

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Preventive Control

Food Safety Plans…

Place importance on a

much wider area… going

far beyond just the

PROCESS.

Preventive Controls Food

Safety Plans must include

the traditional CCPs as

Process PCs, Allergen

and Sanitation PCs as

well as Supply Chain PCs

and ‘others’ if needed.

receiving

storage

packaging

storage

shipping

cooking

cooling

CCP

CCP

Supply

Chain

PCs

Allergen &

Sanitation

PCs

Allergen &

Sanitation

PCs

Allergen &

Sanitation

PCs

labeling

Foreign material

control devices Process PCs

Allergen PCs

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Allergen &

Sanitation

PCs

Allergen &

Sanitation

PCs


Supply chain Preventive Controls

– Aflatoxins, Unapproved pesticides, etc.

Allergen Preventive Controls

– Prevention of cross-contact

– Proper allergen declaration on labels

Sanitation Preventive Controls

– Environmental exposure of RTE foods

– Areas of likely cross-contamination

– Areas of likely allergen cross-contact/

shared equipment

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Required in Preventive Control Food Safety

Plans but NOT required in HACCP Plans…


Training Requirements…

The PCHF rule contains strict training

requirements: every food manufacturer

must have at least one PCQI (Preventive

Controls Qualified Individual) to write,

maintain and implement a risk-based Food

Safety Plan for each type of food made.


This has caused a huge increase in demand for people

having a HACCP background and additional

knowledge of increasingly complex government

regulations required for holding the PCQI qualification.

After the PCHF rule, other Rules have been released

making an ever-increasing number of pieces required

for completion of the FSMA puzzle.

EXAMPLE Hot Sauce Production Flow

(21.) Pre-shipment Review

(20.) Storage

(22.) Shipping to Customers

(19.) Case Pack, Label & Palletize Finished Product

Employee

name

Department/

PositionGMPs

Food

SecurityHACCP

Elo Filler

Operation

Sanitation -

basic

Sanitation -

Chemicals

Robert A. Prod. Machine Op. 1-15-08 1-22-08 2/10/2008 2-15-08

David B. Prod. Manager 1-15-08 1-22-08 1-30-08 2/10/2008 2-22-08

Carlos M. Receiving clerk 1-15-08 1-22-08 1-30-08

Larry M. Sanitation Manager 1-15-08 1-22-08 2-01-08 2-15-08 2-22-08

Elva N. Sanitation worker 1-15-08 1-22-08 1-30-08 2-15-08 2-22-08

Nelly O. QA technician 1-15-08 1-22-08 1-30-08 2/10/2008 2-15-08 2-22-08

Donna S. QA - HACCP Coord. 1-15-08 1-22-08 1-30-08 2/10/2008 2-15-08 2-22-08

Employee Training Log

Training & Date


Additional FSMA Rules…

The Foreign Supplier Verification Program

(FSVP) and Intentional Adulteration Rules (AI),

released subsequent to the PC rule, have added

addition required pieces to the FSMA puzzle

beyond traditional HACCP.

*The IA rule is primarily addressing the “bioterrorism”

component of the Food Defense program

requirements, while the “Economically Motivated

Adulteration” (EMA) and “disgruntled employee”

components are required to be covered in your

Preventive Controls Food Safety Plan.

(*not previously required in HACCP Plans)


Food Fraud?


Ensure that all individuals who perform

activities related to food safety are

qualified to perform their duties.

Personnel AND Supervisors of personnel

assigned to Food Safety activities must

receive appropriate training for their

respective responsibilities in implementation.

Must keep written training records /

documentation of the appropriate trainingfor all employees (beyond HACCP!)


Training Requirement for FSMA Rules…

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Auditors Training required…

“Internal Auditors” as required by GFSI-level 3rd party

audits for verifying compliance with all of the new FDA

requirements, now have new requirements for

credentials showing that they are Qualified Individuals

in regards to auditing.

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PCHF “Supply Chain” requirements include

conducting annual audits of suppliers who

must control significant Supply Chain

Preventive Controls. Persons conducting

audits must have credentials showing they

are Qualified Individuals for auditing.


And in conclusion…

• Food manufacturing companies will need to have their Food

Safety – Preventive Controls Plan, compliant with Foreign

Supplier Verification Programs, and possibly also needing to

comply with the Produce Safety Rule, the Sanitary

Transportation Act, and others, depending on the business.

• The FSMA-puzzle consists of many pieces…

HACCP was just a start to the puzzle. Our job

now is to get ALL the pieces to fit together!

Donna F Schaffner, 2018Slide 12 of 13

Donna F. Schaffner: Assoc. Director Food Safety & Training

Rutgers Food Innovation Center

450 East Broad Street , Bridgeton, NJ 08302

[email protected] (856) 459-1900 x4528

Any Questions?

Utilizing your HACCP Plan as one

component of the FSMA Puzzle


mailto:[email protected]

Documents

Danger! Pitfalls of converting HACCP Plans to FSMA Food ... · The Food Safety Modernization Act (FSMA) is an extensive, complex set of regulations for how food processing businesses