Vulnerability Assessments

Background, Elliott, PAS 96 and TACCP

“The British Standards Institute has worked with Defra and

industry, to develop a Publicly Available Specification ‘Defending

Food and Drink’ (PAS 96).............elements such as the use of the

threats analysis and critical control points, or ‘TACCP’ approach,

are relevant in the prevention of food crime.

BSI and Defra should continue to focus on the TACCP

approach, and to consider the overlap and avoid duplication

between malicious contamination and food crime.

This approach will provide the building blocks of any future

standards that could be developed on preventing food crime.”

Elliott Review into the Integrity and Assurance

of Food Supply Networks – Final Report

Food Fraud

Food Defence

Food Safety

Food Quality

Food Quality, Safety, Fraud and Defence Overlaps

Accidental Acts

Deliberate Actions

Elliott’s Eight Pillars

1. Consumers First

2. Zero Tolerance

3. Intelligence Gathering

4. Laboratory Services

5. Audit

6. Government Support

7. Leadership

8. Crisis Management

GUIDELINE 72 - APPLICATION ROUTE

TACCP TEAM SELECTION

DEFINING THE SCOPE OF THE STUDY / PROCESS FLOW

REVIEW CURRENT TACCP MEASURES IN PLACE

THREAT CHARACTERISATION •Personnel

•Premises

•Process

•Services

•Logistics

•Cybercrime

MITIGATION STRATEGY DEVELOPMENT

HORIZON SCANNING

IMPLIMENTATION

RECORDING / DOCUMENTATION

AUDIT / REVIEW

• TACCP, or Threat Assessment and Critical Control

Point, is a system that was developed in accordance

with the PAS96:2010.

• Title for the revised PAS96:2014 is,

“Guide to protecting and defending food and drink from

deliberate attack”,

Updated from PAS96:2010,

“Defending food and drink. Guidance for the deterrence,

detection and defeat of ideologically motivated and

other forms of malicious attack on food and drink and

their supply arrangements”

Seven Sources of Food Fraud

•UNAPPROVED ENHANCEMENTS Melamine added to enhance protein value

Use of unauthorized additives (Sudan dyes in spices)

•COUNTERFEITING Copies of popular foods – not produced with acceptable safety assurances.

•DILUTION Watered down products (Also, potentially using non-potable / unsafe water)

Olive oil diluted with cheaper substitutes

•SUBSTITUTION Sunflower oil partially substituted with mineral oil

Hydrolyzed leather protein in milk

•CONCEALMENT Poultry injected with hormones to conceal disease

Harmful food colouring applied to fresh fruit to cover defects

•MISLABELLING Expiry of dates, provenance (unsafe origin)

Toxic Japanese star anise labelled as Chinese star anise

Mislabelled recycled cooking oil

•GREY MARKET PRODUCTION / THEFT / DIVERSION Sale of excess unreported product

“A documented Vulnerability Assessment shall be carried

out of all raw materials to assess the potential risk of

adulteration or substitution.

This shall take into account:

•Historical evidence of substitution or adulteration

•Economic factors

•Ease of access to raw materials through the supply chain

•Sophistication of routine testing to identify adulterants

•Nature of the raw material”

BRC V7 New Clause 5.4.2

“A number risk assessment tools have been published

including some specialist vulnerability assessment tools,

for example CARVER+Shock and TACCP (Threat

Assessment Critical Control Points), which may be used

to achieve a structured approach to the assessment

process.”

BRC V7 Interpretation Guide

“A vulnerability assessment is a search for potential

weaknesses in the supply chain in order to prevent food

fraud i.e. to prevent the adulteration or substitution of raw

materials before they arrive at the site.

The aim of the assessment is not to assess the potential for

fraud at the site, but to examine the supply chain for

potential concerns or weaknesses to identify those raw

materials which are of particular risk of adulteration or

substitution, such that appropriate controls need to be put in

place.”

BRC V7 Interpretation Guide

“Typical information to incorporate into the assessment includes:

• Any emerging issues and information identified

• Historical evidence of substitution or adulteration of the ingredient

• Cost/value of material

• Availability - for example, a poor harvest may restrict availability and

may increase the potential for adulteration

• Sophistication of routine testing to identify adulterants – if testing

within the supply chain is comprehensive and specifically focused on

potential fraud issues, then the likelihood of adulteration is reduced.

• Country of origin

• Length and complexity of the supply chain

• The nature of raw material may change the potential for food fraud”

BRC V7 Interpretation Guide

“Output from the vulnerability assessment

Where raw materials are identified as being of particular risk then

appropriate assurance controls need to be in place to ensure that

only genuine materials are purchased.

Depending on the perceived risk assurance controls may include:

• Certificates of analysis from raw material suppliers

• Raw material testing

• Supply chain audits

• Use of tamper evidence or seals on incoming raw materials

• Enhanced supplier approval checks

• Mass balance exercises at the raw material supplier

• Changes to the supply chain eg a change of supplier or a move to a

shorter supply chain”

BRC V7 Interpretation Guide

CARVER + shock

A method from the FDA that puts a scoring system on attributes of:

• Criticality - measure of public health and economic impacts of an

attack

• Accessibility - ability to physically access and egress from target

• Recuperability - ability of system to recover from an attack

• Vulnerability - ease of accomplishing attack

• Effect - amount of direct loss from an attack as measured by loss

of production

• Recognizability - ease of identifying target

• shock - the combined health, economic, and psychological

impacts of an attack

Vulnerability Assessment

Section 106 of the Food Safety Modernization Act (FSMA)

• requires the FDA, among other things, to conduct a

Vulnerability Assessment (VA) of the food system

• A VA is the process of identifying, quantifying, and

prioritizing (or ranking) the vulnerabilities in a system

FSMA - What is a

Vulnerability Assessment?

• In food safety there are "hazards" to accidental contamination

• In food defense there are "vulnerabilities" to intentional contamination.

• In calculating risk of intentional threat, the common measure of

vulnerability is the likelihood that an attack succeeds, if it is attempted

• By conducting a vulnerability assessment of a food production facility or

process, you can determine the most vulnerable points in the

infrastructure and focus resources on the most susceptible points

TACCP & HACCP

Differences and Integrating the Systems

A Quote…..

“There are known known's.

These are things we know that we know.

There are known unknowns.

That is to say, there are things that we know we don't know.

But there are also unknown unknowns.

There are things we don't know we don't know.”

Donald Rumsfeld, US Secretary of Defense - February 2002

It could be said that HACCP is perhaps a study of the

“known known's” and the “known unknowns”.

TACCP is an analysis of some “known unknowns” and

“unknown unknowns”.

Key Differences

• The team may cover the need for slightly different or additional disciplines

• The Process Flow Diagram (PFD) will be written to capture the entire process,

not just that which takes place at the manufacturer’s site

• As a result of the requirements, the potential hazards may detail not only

Chemical, Physical and Biological hazards, but also cover the elements of

radiological hazards and of adulteration.

• Potential contaminants within the TACCP study may not be confined to those

which are pertinent to the process involved (e.g. Metal swarf from stirrer blade)

• At times with TACCP, the specific hazard at each process step might not be

listed.

• TACCP suggests implementing response levels of ‘Normal’, ‘Heightened’ and

‘Exceptional’, in parallel with Prerequisite programmes and Critical Control

Points.

Weigh batch seasonings and other ingredients

Primal Intake of Beef Primal Intake of Pork

Store in Freezer

Thaw Store in Chill

Weigh Primals

Mince through 5mm plate

Weigh batch Quantity Minced Beef

Store in Freezer

Thaw Store in Chill

Weigh Primals

Mince through 5mm plate

Weigh batch Quantity Minced Pork

Blend minced Beef, minced Pork and other ingredients

Discharge into tote bins

Store in Chill

Form meatballs on forming machine

Place in containers / trays / packaging

Chill or Freeze

Dispatch Load Vehicle

Central delivery Depot

Deliver to meatball in sauce manufacturer

Flow diagram - Meatball manufacture

Intake of other ingredients

Storage

FSMA Vulnerability Assessment

The key activity types identified in the most vulnerable

production environments are:

• Coating / Mixing / Grinding / Rework

• Ingredient Staging / Prep/Addition

• Liquid Receiving / Loading

• Liquid Storage / Hold / Surge Tanks

Primal Intake of Beef Primal Intake of Pork

Store in Freezer

Thaw Store in Chill

Weigh Primals

Mince Through 5mm Plate

Weigh Batch Quantity Minced Beef

Store in Freezer

Thaw Store in Chill

Weigh Primals

Mince Through 5mm Plate

Weigh Batch Quantity Minced Pork

Blend Minced UK Beef, Minced Pork / Ingredients

Discharge Into Tote Bins Store in Chill

Form Meatballs on Forming Machine

Place in Containers / Trays / Packaging

Chill or Freeze

Dispatch Load Vehicle

Central delivery Depot

Deliver to Meatball in Sauce Manufacturer

TACCP

Human Elements

• Significantly more males engaged in insider activity (82%) than

females (18%)

• The majority of insider acts were carried out by permanent staff

(88%); only 7% of cases involved contractors and only 5% involved

agency or temporary staff

• 60% of cases were individuals who had worked for their organisation

for less than five years

• 49% of insider cases occurred within the 31-45 years age category.

Instances of insider cases increased with age until they peaked within

this category and then decreased beyond 45 years of age

The Centre for the Protection of National Infrastructure (CPNI's)

Insider Data Collection Study indicated:

Human factors

Human Factors

Errors

Violations

Mistakes

Skill based errors

Slips of action

Lapses of memory

Knowledge based

mistakes

Exceptional

Rule based mistakes

Routine

Situational

Intended to set dial to

3 accidentally set to 6

Thought the setting

should be 4 when in

fact it should be 6

Used baking powder

instead of baking soda

Used a thermometer

that wasn’t calibrated

Knows to follow steps 1

to 10 in order but always

performs steps 1-5, 7-10

then step 8

When under time or

other constraints, the

action not carried out

as per the procedure

Disgruntled employee

received a warning that

day and chose to act in a

way they shouldn’t

Complacency, Incompetence,

Criminality: 3 Business Threats

Subject Matter:

• Complacency – “Smug self satisfaction”

• Incompetence – “Lacking the necessary skill”

• Criminality – “Tendency to illegal acts”

• Sudan dyes

• Melamine

Case study I: Sudan dyes (genotoxic carcinogens, prohibited for use in food)

May’03 France reports Sudan dyes

as an issue in Indian chilli

products

Jul’03 Pan-EU controls introduced

Feb’04 FSA reminds UK industry of

issue

Jan’05 56 Alerts issued in UK since

2003

Feb’05 Worcestershire sauce found

with sudan (made with 2002

chilli)

Mar’05 580 products withdrawn

from the UK market

Case Study II: Melamine

2005/6 Local reports of melamine as an

in issue in Chinese milk

Mar’07 First US pet deaths directly

attributable to melamine

Aug’07 >5300 products recalled

Jun’08 Linkage between baby kidney

damage and Sanlu milk in Gansu

province

Aug’08 Melamine found by Fonterra (NZ)

Sep’08 Fonterra advise NZ government

who advise the Chinese govt.

Significance of problem

recognised

Dec’08 Estimated number of cases:

>250,000 babies & infants

Points to consider

• Understand the historical perspective

• Inevitable lag time between commencement and

detection

• Value of certification

• Adulteration often relates to value (money) determining

product attributes

– Attribute quality is often measured to an indirect or subjective

end-point (e.g. Colour)

• Fraud is becoming more sophisticated

– “chemically identical” substitutes (e.g. vanilla)

– Commodity items (e.g. olive oil / basmati rice / tomato paste)

How To Conduct a TACCP Study

APPLICATION ROUTE / LOGIC TABLE

TEAM SELECTION

DEFINING THE SCOPE OF THE STUDY / PROCESS FLOW

REVIEW CURRENT TACCP MEASURES IN PLACE

THREAT CHARACTERISATION •Personnel

•Premises

•Process

•Services

•Logistics

•Cybercrime

MITIGATION STRATEGY DEVELOPMENT

HORIZON SCANNING

IMPLIMENTATION

RECORDING / DOCUMENTATION

AUDIT / REVIEW

Impact

Likelihood

5

4

3

2

1

1 2 3 4 5

Threats categorised by likelihood / impact and plotted

EXCEPTIONAL

HEIGHTENED

NORMAL

No. Process step

description

Step

No.

Threat description and job role

involved

Response:

Normal

Heightened

Exceptional

Preventative Actions / Control

Measures

Severity Likelihood Total

1

2

3

DOC REF: TACCP1 DATE: XX/XX/XX

EDITION: 1 VERSION: 1

TACCP ANALYSIS: FOOD SECURITY

Product / Process:

Thank you

Lorraine Green

Quality Management Systems Specialist – Campden BRI

Tel: 01386 842458

Email: Lorraine.green@campdenbri.co.uk