A Free Software For Food Industries To Ensure Food Safety: CARVER + Shock
A Free Software For Food Industries To Ensure Food Safety: CARVER + Shock
A Free Software For Food Industries To Ensure Food Safety: CARVER + Shock
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A Free Software for Food Industries to Ensure Food Safety: CARVER + Shock
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Abstract: Bio-terrorism is not a new term for scientists. Post 9/11 the United States of America, as well as other
countries which have grown well economically and countries undergoing the metamorphosis to developed nations,
are under serious threat of bio-terrorism. This has led to the development of the software CARVER + Shock by
Sandia National Laboratories and Food and Drug Administration (FDA), specifically for risk assessment and protection
mechanism in the entire food supply chain from farm to table. This software requires training on the software front and
interaction with industry people to chalk out a plan to safeguard the premises and the supply chain of the food products in
the industry manufacturing. Such efforts should be well highlighted and advertised among food processing professionals,
educators, students, and those government agencies concerning the food safety issues. Everyone must look at this software
as this is going to be the future of food processing safety. This system works like Hazard Analysis and Critical Control
Points and can be integrated for total quality management of the concerned industry. Our study has highlighted the
application of this software in various food industries showing its strength and weaknesses.
Table 1–Criticality.
Criticality: A target is critical when introduction of threat agents into food at this location would
have significant health or economic impact. Example metrics are:
Loss of over 10,000 lives OR loss of > 90% of the total economic value. 9-10
Loss of life is between 1,000-10,000 OR loss of between 61% and 90% of the total 7-8
economic value.
Loss of life is between 100 and 1000 OR loss of between 31% and 60% of the total 5-6
economic value.
Loss of live is less than 100 OR loss of between 10% and 30% of the total economic 3-4
value.
conditions associated with higher attractiveness as a target (or r What is the endpoint of concern (food borne illness and death
higher vulnerability) are assigned higher values (9 or 10). Eval- or economic impacts and so on.);
uating or scoring the various elements of the food sector infras- r What type of attacker and attack you are trying to protect
tructure of interest for each of the CARVER + Shock attributes against. Attackers could range from disgruntled employees to
can help identify where within that infrastructure an attack is most international terrorist organizations. Those different attackers
likely to occur (USFDA 2007a). have different capabilities and different goals. For example, a
Federal agencies, such as the Food Safety and Inspection Ser- major assumption used by FSIS and FDA in their vulnerability
vice (FSIS) and the FDA, have used this method to evaluate the assessments is that one of the goals of terrorist organizations
potential vulnerabilities of farm-to-table supply chains of various is to cause mass mortality by adding acutely toxic agents to
food commodities. The method can also be used to assess the po- food products. That assumption has a major impact on the
tential vulnerabilities of individual facilities or processes (Acheson scoring of the various parts of the supply chain and the scales
2007a). for the attributes (see below) have been developed with that
in mind;
Steps for conducting a CARVER + Shock analysis r What agent(s) might be used? The agent used in your sce-
Step 1—establishing parameters. Before any scoring can be- nario will impact the outcome of the assessment. Potential
gin, the scenarios and assumptions you wish to use in the analysis agents include biological, chemical, or radiological agents.
must be established in order to guide all further steps. That is, you Different agents have different properties such as potency,
need to answer the question of what you are trying to protect and heat stability, pH stability, half-life that will determine the
what you are trying to protect it from. Those parameters include: impact of an intentional contamination incident (USFDA
r What food supply chain you are going to assess (hot dog 2007a).
production or deli meat production or chicken nugget pro- Step 2—assembling experts. A team of subject matter experts
duction, an overall assessment based on the generic process should be constituted to conduct the assessment. The team should
from farm to table or postslaughter processing in a specific consist, at a minimum, of experts in food production (specifically
facility and so on.); for the food process being evaluated), food science, toxicology,
110 Comprehensive Reviews in Food Science and Food Safety r Vol. 10, 2011 c 2011 Institute of Food Technologists®
A free software for food industries to ensure food safety. . .
Table 2–Accessibility.
Accessibility: A target is accessible when an attacker can reach the target to conduct the attack
and egress the target undetected. Accessibility is the openness of the target to the threat. This
measure is independent of the probability of successful introduction of threat agents. Example
metrics are:
Easily Accessible (e.g., target is outside building and no perimeter defense). Limited 9-10
physical or human barriers or observation. Attacker has relatively unlimited access to
the target. Attack can be carried out using medium or large volumes of contaminant
without undue concern of detection. Multiple sources of information concerning the
facility and the target are easily available.
Accessible (e.g., target is inside building, but in unsecured part of facility). Human 7-8
observation and physical barriers limited. Attacker has access to the target for an hour
or less. Attack can be carried out with moderate to large volumes of contaminant, but
requires the use of stealth. Only limited specific information is available on the facility
and the target.
Partially Accessible (e.g., inside building, but in a relatively unsecured, but busy part 5-6
of facility). Under constant possible human observation. Some physical barriers may be
present. Contaminant must be disguised, and time limitations are significant. Only
general, non-specific information is available on the facility and the target.
Hardly Accessible (e.g., inside building in a secured part of facility). Human 3-4
observation and physical barriers with an established means of detection. Acces
generally restricted to operators or authorized persons. Contaminant must be disguised
and time limitations are extreme. Limited general information available on the facility
and the target.
Not Accessible. Physical barriers, alarms, and human observation. Defined means of 1-2
intervention in place. Attacker can access target for less than 5 minutes with all
equipment carried in pockets. No useful publicly available information concerning the
target.
epidemiology, microbiology, medicine (human and veterinarian), include the raw materials receiving area, processing area, storage
radiology, and risk assessment. The team will apply the CARVER area, shipping area, and so on), and to the smallest possible nodes
+ Shock method to each element of food system infrastructure and (for example, individual pieces of equipment) (FDA 2007; News
come to a consensus on the value from 1 to 10 for each attribute, 2007; Pohl 2007 ).
using the scenario and assumptions established in Step 1 (Rigby Step 4—assigning scores. Once the infrastructure has been
2006; USFDA 2007b ). broken down into its smallest parts (components and nodes), these
Step 3—detailing food supply chain. The analysis begins by can be ranked or scored for each of the 7 CARVER + Shock
developing a description of the system under evaluation. attributes to calculate an overall score for that node. The nodes
A graphical representation (flow chart) of the system and its sub- with the higher overall scores are those that are potentially the
systems, complexes, components, and nodes (its smaller structural most vulnerable nodes (and, therefore, most attractive targets for
parts) should be developed to facilitate this process. For example, if an attacker). The rationale for a particular consensus score should
you are evaluating hot dog production, the food system is hot dog be captured (Donald Kautter 2006; Danneels 2007).
production that can be broken down into subsystems (production Step 5—applying what has been learned. Once the critical
of live animals subsystem, slaughter/processing subsystem, distri- nodes of the system have been identified, a plan should be
bution subsystem). Those subsystems can be further broken down developed to put countermeasures in place that minimize the
into complexes (such as slaughterhouse facility and processing fa- attractiveness of the nodes as targets. Countermeasures might in-
cility) Those can be broken down into components and would clude enhancements to physical security, personnel security, and
Table 3–Recuperability.
Recuperability: A target’s recuperability is measured in the time it will take for the specific facility
to recover productivity. Example metrics are:
Table 4–Vulnerability.
Vulnerability: A measure of the ease with which threat agents can be introduced in quantities
sufficient to achieve the attacker’s purpose once the target has been reached. Vulnerability is
determined both by the characteristics of the target (e.g., ease of introducing agents, ability to
uniformly mix agents into target) and the characteristics of the surrounding environment (ability to
work unobserved, time available for introduction of agents). It is also important to consider what
interventions are already in place that might thwart an attack. Example metrics are:
Target characteristics allow for easy introduction of sufficient agents to achieve aim. 9-10
Target characteristics almost always allow for introduction of sufficient agents to 7-8
achieve aim.
Target characteristics allow 30 to 60% probability that sufficient agents can be added to 5-6
achieve aim.
Target characteristics allow moderate probability (10 to 30%) that sufficient agents can 3-4
be added to achieve aim.
Target characteristics allow low probability (less than 10%) sufficient agents can be 1-2
added to achieve aim.
Table 5–Effect.
112 Comprehensive Reviews in Food Science and Food Safety r Vol. 10, 2011 c 2011 Institute of Food Technologists®
A free software for food industries to ensure food safety. . .
Table 6–Recognizability.
Recognizability Scale
The target is clearly recognizable and requires little or no training for recognition 9-10
The target is easily recognizable and requires only a small amount of training for 7-8
recognition
The target is difficult to recognize or might be confused with other targets or target 5-6
components and requires some training for recognition
The target is difficult to recognize. It is easily confused with other targets or 3-4
components and requires extensive training for recognition
The target cannot be recognized under any conditions, except by experts. 1-2
Table 7–Shock.
Shock: Shock is the final attribute considered in the methodology. Shock is the combined
measure of the health, psychological, and collateral national economic impacts of a successful
attack on the target system. Shock is considered on a national level. The psychological impact
will be increased if there are a large number of deaths or the target has historical, cultural,
religious or other symbolic significance. Mass casualties are not required to achieve widespread
economic loss or psychological damage. Collateral economic damage includes such items as
decreased national economic activity, increased unemployment in collateral industries, etc.
Psychological impact will be increased if victims are members of sensitive subpopulations such
as children or the elderly.
Shock Scale
Target has major historical, cultural, religious, or other symbolic importance. Loss of 9-10
over 10,000 lives. Major impact on sensitive subpopulations, e.g., children or elderly.
National economic impact more than $100 billion.
Target has high historical, cultural, religious, or other symbolic importance. Loss of 7-8
between 1,000 and 10,000 lives. Significant impact on sensitive subpopulations, e.g.,
children or elderly. National economic impact between $10 and $100 billion.
Target has moderate historical, cultural, religious, or other symbolic importance. Loss of 5-6
life between 100 and 1,000. Moderate impact on sensitive subpopulations, e.g.,
children or elderly. National economic impact between $1 and $10 billion.
Target has little historical, cultural, religious, or other symbolic importance. Loss of life 3-4
less than 100. Small impact on sensitive subpopulations, e.g., children or elderly.
National economic impact between $100 million and $1 billion.
Target has no historical, cultural, religious, or other symbolic importance. Loss of life 1-2
less than 10. No impact on sensitive subpopulations, e.g., children or elderly. National
economic impact less than $100 million.
operational security that help to minimize aggressor access to the (1) Windows NT Service Pack 4
product or process (Catlin and Kautter 2007). (2) Windows 98
(3) Windows 2000
Description of attributes and scales (4) Windows XP (Brackett 2003, 2005;Acheson 2007a, 2007b;
The following section defines the attributes used by FDA and Barringer 2007; Busta 2007; Catlin and Kautter 2007)
USDA to conduct their vulnerability assessments and provides the CARVER is available on FDA’s Web site at http://www.fda.
scales used by the agencies for scoring each attribute. These scales gov/Food/FoodDefense/CARVER/default.htm. The source file,
were developed with the mindset that mass mortality is a goal of carver.exe, is approximately 53.53 MB (USFDA 2005;Donald
terrorist organizations. It is important to remember, however, that Kautter 2006;Danneels 2007; FDA 2007; News 2007; Pohl 2007;
any intentional food contamination could also have major psy- USFDA 2007c, 2008). Installation prerequisite of this program
chological and economic impacts on the affected industry. Tables requires.NET availability on the system you are running. The
to assist in calculating the public health impacts and the overall auto-executable file dotnetfx.exe (22.4 MB) can be downloaded
CARVER + Shock scores can be found in Table 8 and 9, respec- from the Microsoft Corp.’s global site and should be run prior to
tively (USFDA 2005; News 2007). carver.exe
CARVER + Shock scoring table (individual facilities). See Table
When properly installed and having chosen default settings in
1 to Table 7. the Windows XP operating system, go to Start—All Program—
fda—CARVER (see figure 1).
Criticality of the attack Front end window of CARVER + Shock software opens up.
This table can be used to calculate the potential number of
In the quick-start pop-up window 3 categories represent the
deaths and illnesses resulting from addition of a particular adulter-
fields namely User Assistance, Process Diagram, and Information
ant at a particular point in a given food production process. Details
(Figure 1).
of the batch size to which the adulterant is added, the number of
User Assistance section has 3 tab buttons: Help, User Manual,
servings that will be sold and eaten from that batch, and the char-
and Tutorial. First-time users must undertake a journey to the
acteristics of the adulterant (including its lethality) must be known
User Manual first, which is a document file explaining in detail the
to use this worksheet. The numbers generated in this worksheet
theory behind CARVER + Shock software and also its technical
will help determine where on the criticality scale a given attack
details.
will fall (see table 8).
For a novice, Tutorial is of utmost help as in this section a video
Summary sheet for total scores. This table can be used to total
tutorial file teaches how to use this software in less than 5 min.
the scores across the CARVER + Shock attributes for each node.
The Process Diagram section has 2 tabs: New for creating a new
The totals can then be compared across the various nodes to deter-
session and Open for opening an existing session.
mine which nodes are critical. The nodes with the highest scores
The Information section has 2 tabs: Websites, clicking
are the “critical nodes” and should be the focus for beginning to
on it opens the link http://www.fda.gov/Food/FoodDefense/
implement countermeasures (see table 9).
CARVER/default.htm in the default web browser and the other
tab Contacts opens the same link (USFDA 2005; Donald Kautter
Software Installation and Startup 2006Danneels 2007; ; FDA 2007; News 2007; Pohl 2007; USFDA
The software CARVER + Shock is copyrighted by Sandia Na- 2007c, 2008).
tional Laboratories and FDA. Its version 1.0.0.0 is available for The main window has 3 menus on the menu bar: File, Window,
usage for free. and Help. This gives the software a clean look but at the same time
CARVER + Shock runs on hardware systems with the follow- also gives the notion to the user that this software is in the initial
ing minimum performance characteristics: stages of its development as evident from the version number from
(1) Pentium I processor the help menu.
(2) 256 MB RAM The Window menu has 2 options, Cascade and Tile, to arrange
(3) 120 MB available hard disk space the multiple windows opened in the program.
(4) CD ROM drive The File menu has options, New to create a new session, Open
(5) Video card displaying 1280 × 1024 desktop area. for opening an existing session, and Quick Start to open quick-
The software is compatible with the following operating sys- start pop-up window. Other buttons are Edit, Delete, Export,
tems: Import, and Exit options.
Entry Point Agent Batch Serving Serving Dose Total Distribution Units % of Units Sold Units for Consumers Number of % of Units No. of Morbidity/ No. of
Size Size per Batch Required Amount Unit Produced Before Warning Potential per Potential Consumed Exposures Mortality Illness/
per Required Consumption Distribution Exposures Before Rate Deaths
Serving per Batch Unit Warning
1. 1.
2. 2.
114 Comprehensive Reviews in Food Science and Food Safety r Vol. 10, 2011 c 2011 Institute of Food Technologists®
A free software for food industries to ensure food safety. . .
Table 9–Summary sheet for total scores for nodes across CARVER + Shock attributes.
FOOD:_______________________________________________
RECOGNIZABIL
ACCESSIBILITY
RECUPERABILI
VULNERABILIT
CRITICALITY
SCHOCK
EFFECT
OVERALL
ITY
TY
TARGET
Y
SCORE
(Nodes)
To start with the real procedure, one must use the default tem- (2) Answer a series of questions for each of the seven
plates supplied with the software available when you click on CARVER + Shock attributes for each process flow diagram
File—Open (Figure 2). node.
The process can be edited and used for any food industry. Each question has an associated score. Based on the answers
CARVER + Shock Scoring Table (Individual Facilities) is given given, the software calculates a score for each CARVER + Shock
in this article and must be referred to for standard scores. This attribute and adds them up to produce a total score for each node.
table must be taken as reference scale when designing the process Analogous to a face-to-face session, total scores range from 1 to
diagram of any industry (see Figure 2). 10 for each CARVER + Shock attribute and therefore 7 to 70
CARVER + Shock software mimics the thought processes in for each node. The user may view the attribute scores and total
play during a face-to-face CARVER + Shock session by having for each node, the total scores for all nodes, and the attribute
the user: scores for all nodes (for example, all the node Criticality scores,
(1) Build a process flow diagram for the system to be evaluated. Accessibility scores, and so on) (USFDA 2005; Donald Kautter
2006; Acheson 2007a; Danneels 2007; FDA 2007; News 2007; Busta 2007; Catlin and Kautter 2007; Green 2007; Harlander
Pohl 2007; USFDA 2007a, 2007c, 2008). 2007).
The software was used and tested for ruggedness on all the
platforms mentioned in the manual and was found to be quite
Results and Discussion stable as the application did not crash even a single time. So hats
Sandia is a National Nuclear Security Administration labora- off to the Sandia people.
tory. A team from Sandia National Laboratories led the effort to While testing, some points emerged and are mentioned here as
computerize the FDA program so that it will be distributed as a suggestion for improvement. These points were sent to the FDA
widely as possible (USFDA 2005; Keller and Killorin 2006; Rigby and Sandia National Laboratories for their consideration.
2006; SPPA 2006; IFT 2007a, 2007b; SPAA 2007; Wordpress (1) File menu has options, New to create a new session, Open
2007a, 2007b). for opening an existing session, Quick Start to open a quick-
This indeed is a marvelous effort by Sandia National Labora- start pop-up window. Other buttons are Edit, Delete, Export,
tories and FDA to start a new age of solutions for the problem, Import, and Exit options. The compact look of this software
which is now in its infancy but will soon be a giant to fight provides a very easy impression and thus a psychological effect
against BIO-TERRORISM. The food-defense project began in to the user, which is very much required when you are trying
longhand; in effect, in response to the federal Bioterrorism Act of to incorporate such software in an established firm or industry
2002, which said the industry should be prepared to defend against that may be set in its way.
any contingency that might arise (Brackett 2003, 2005; Donald (2) Information section has 2 tabs: Websites clicking
Kautter 2006; Barringer 2007; Busta 2007; Catlin and Kautter opens the link http://www.fda.gov/Food/FoodDefense/
2007; Green 2007; Harlander 2007). CARVER/default.htm in the default web browser and the
Food defense is a national and of international priority for the other tab Contacts opens the same link. This repetitive link
food industry and the government. Product developers, research could have been avoided or the Contacts tab could have been
and management professionals, regulators, academics, and anyone designated to some other webpage for feedback and questions
involved in food safety and quality will find this software useful to pertaining to CARVER.
enhance their awareness of and professional development in the (3) In the Help menu there must be an auto update link to update
field ( Brackett 2003, 2005; Donald Kautter 2006; Barringer 2007; the patches, if any.
116 Comprehensive Reviews in Food Science and Food Safety r Vol. 10, 2011 c 2011 Institute of Food Technologists®
A free software for food industries to ensure food safety. . .