Term
| The risk assessment process can be divided into 4 different activities. |
|
Definition
1. Hazard identification
2. Exposure assessment.
3. Hazard characterization.
4. Risk characterization. |
|
|
Term
| What three population groups were modeled in the L. monocytogenes risk assessment? |
|
Definition
Perinatal:
Elderly:
Intermediate-age group: |
|
|
Term
| Risk characterization was determined using a computer simulation. |
|
Definition
| Two-dimensional Monte Carlo simulation |
|
|
Term
| Twenty-four different food categories were evaluated and given a risk designation. What two products were given the risk designation very high? |
|
Definition
| Deli Meats and Frankfurters (not reheated) |
|
|
Term
| In the conclusion section what temperature does it say home refrigerators should be kept at to reduce the risk of L. monocytogenes in deli meats? |
|
Definition
|
|
Term
| "potentially hazardous food" (PHF) |
|
Definition
| developed by the United States Public Health Service during the last half of the twentieth century to regulate perishable food or drink in eating and drinking establishments |
|
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Term
|
Definition
| CARVER + Shock is a prioritization tool that can be used to assess the vulnerabilities within a system or infrastructure in the food industry. By conducting a CARVER + Shock assessment of a food production facility or process, the user can focus resources on protecting the most susceptible points in their system. |
|
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Term
| What Does C-A-R-V-E-R + Shock Mean? |
|
Definition
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 in production
Recognizability - ease of identifying target
Shock, has been added to the original six to assess the combined health, economic and psychological impacts of an attack within the food industry. |
|
|
Term
| How Do Federal Agencies Apply CARVER + Shock as a Food Defense Tool? |
|
Definition
| Federal agencies, such as the Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA), have used the CARVER + Shock method to evaluate the potential vulnerabilities of farm-to-table supply chains of various food commodities, as well as individual facilities or processes. |
|
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Term
|
Definition
| Conducting face-to-face CARVER + Shock evaluations is resource-intensive and limiting in terms of the number of evaluations that can reasonably be conducted in any given time frame |
|
|
Term
| Physical Methods Control of Biological Hazards |
|
Definition
Dehydration
Cool Storage
Freezing and Frozen storage
Heat treatment
Irradiation
Ionizing radiation
High pressure processing |
|
|
Term
|
Definition
•Removal of Water
Reduces moisture content
Aw – available water
•Reduction in water limits the ability of the cell to grow
•During drying high temperature and low moisture content
•Freeze drying?
•Some die off can occur in product over time, but dehydration is not thought of as a lethality process |
|
|
Term
|
Definition
•Low rate of chemical reactions
•Low rate of growth
•Allows for the growth of psychrophilic and psychrotrophic (can thrive in low temperatures) |
|
|
Term
| Freezing and Frozen storage |
|
Definition
•Both temperature and Aw decrease
•Quick vs. slow freezing
•Concentration of cellular liquids
•Thawing
•Some cells
Injury – die
Injury – repair and survive
•Composition of the food
Sucrose, gelatin, proteins |
|
|
Term
|
Definition
•Wet heat – kills Microorganisms by denaturing nucleic acids, proteins, enzymes
•Dry Heat – kills Microorganisms by dehydration and oxidation
•Death is time temperature dependent
•Product composition can influence heat resistance
pH, salt, sugar, fat |
|
|
Term
|
Definition
• UV Radiation
Wavelength 240-280 most destructive
Inactivation a result of DNA damage (prevents repair and reproduction)
Low penetration and even exposure is the major drawback
Surfaces or liquid foods
• Ionizing radiation
Damages DNA
Sensitivity is roughly inversely proportional to the size and complexity of an organism
•Insects > non-spore forming bacteria, bacteria, spores, viruses
Food Matrix can influence sensitivity
•Complex matrix, reduced Aw, temperature |
|
|
Term
|
Definition
• Pressure is transferred through the food instantly and uniformly
• HPP disturbs noncovalent bonds of proteins and carbohydrates (hydrogen bonds, ionic and hydrophobic bonds)
Protein function, membrane function
•Vegetative vs. spores
•Heat and pressure
•Water activity |
|
|
Term
| Chemical Preservatives and Natural Antimicrobial Compounds |
|
Definition
o Organic Acids and Esters
o Nitrites
o Lysozyme
o Chitosan
o Plant Sources |
|
|
Term
|
Definition
• Effectiveness of organic acids is related to pH and the undissociated form of the acids
• pH of product and pKa of the acid must be known
• pKa –undissociated form responsible for inhibition |
|
|
Term
|
Definition
(pKa 4.75)
Bacillus spp., Campylobacter jejuni, Clostridium spp., E. coli, L. monocytogenes, Salmonella, S. aureus |
|
|
Term
|
Definition
(pKa 3.79)
Clostridium botulinum, L. monocytogenes, Salmonella, S. aureus, E. coli 0157:H7 |
|
|
Term
|
Definition
(pKa 4.75)
Bacillus, Campylobacter, Clostridium, E. coli 0157:H7, S. aureus, Salmonella, Vibrio |
|
|
Term
|
Definition
• Sodium nitrite, potassium nitrite
• Used to control the growth of C. botulinum
• Variable effect on other microorganisms
• Inhibits the out growth of germinated spores |
|
|
Term
|
Definition
• Enzyme present in avian eggs, mammalian milk, tears, and fish
• Catalyzes breakdown of peptidoglycan
• Most active against gram-positive bacteria
• Received GRAS status in 1998
• Approved for use in casings for frankfurters
• Japan (preserve seafood, vegetables, pasta, and salads |
|
|
Term
|
Definition
• Produced commercially from chitin, a by-product of shellfish processing
• Inhibits growth of E. coli, L. monocytogenes, Salmonella, S. aureus
• Mechanism poorly understood
Alter membrane permeability or prevent transport
Interfere with protein synthesis |
|
|
Term
|
Definition
• Spices – cloves, cinnamon, oregano and thyme
• Applied via dips, incorporated into edible films
• Mechanism of action
Effects cell membrane
Increase permeability
• Phenolic compounds
Wood smoke, tea, apples, grapes
• Salmonella, E. coli, L. monocytogenes, Clostridium
• Cause leakage of cells
• May inhibit cellular proteins |
|
|
Term
|
Definition
use of microorganisms and/or their metabolic products to preserve foods that are not considered fermented
• Controlled acidification
• Bacteriocins
• Bacteriophages |
|
|
Term
| • Controlled acidification |
|
Definition
Lactic acid bacteria (LAB) can produce lactic acid in situ
Used to inhibit C. botulinum growth under conditions of temperature abuse |
|
|
Term
|
Definition
Antimicrobial peptides produced by bacteria (LAB)
Increased interest due to the consumers desire for natural products
Nisin most widely used, commercially available and well studies
Nisin can be directly added to the food, added via a fermentate, use bacteriocin producing starter cultures
Effective against Gram positive bacteria
• L. Monocytogenes
• C. botulinum
Nisin creates pores in the cell membrane |
|
|
Term
|
Definition
1930s and 40s marketed by pharmaceutical companies
viruses whose only hosts are bacteria
•attach to sensitive bacterial cells, take over metabolic machinery, produce more phages and burst the cells
natural components of food microbiota
stable over a wide pH range, but inactivated by heat
Things to consider
• If host is not growing then high number of bacteriophages are needed
• Limited host range
• Potential for resistance
o Destroy
o Slow growth
o Stop toxin production |
|
|
Term
|
Definition
o US law required imported food to meet the same FS requirements
o Pure, wholesome, safe to eat, produced under sanitary condition
o Food labels must be informative and truthful and in English
o Product can be denied if it appears to be adulterated or misbranded |
|
|
Term
| FDA – process Import safety |
|
Definition
• Prior notice of importation
• Import food facility registration
• 5 working days of shipment arrival, importer must file entry documents with customs
low-acid canned foods
acidified foods
permit for milk and cream
baby formula |
|
|
Term
| • FDA notified of entry and review documents |
|
Definition
| Physical examination: Sample taken for analysis (they based if off the product and choose to do further inspection of the product) |
|
|
Term
| FDA sends notice to customs |
|
Definition
“may proceed notice” and “notice of sampling”
“release notice” and “notice of detention and hearing” |
|
|
Term
| What happens if a violation is found? (Import saftey) |
|
Definition
Issue a “notice of FDA Action”
Owner is entitled to an informal hearing
• Burden lies with the owner
If appeal fails FDA issues another “notice of FDA action”
• Exported or destroyed within 90 days
Product could be brought into compliance
• Relabeled
• reconditioned |
|
|
Term
| USDA has jurisdiction over what agency's? |
|
Definition
• APHIS (animal and plant health inspection service)
Charged with protecting US agriculture
Aims to keep exotic animal and poultry disease out of US
• Foot-and-mouth, avian influenze
Meat, poultry and egg imports fall under customs and APHIS first
• If no pest or disease of concern is detected product control goes to FSIS
• FSIS ( food safety Inspection service)
• NCIE (National center for import and export) |
|
|
Term
| CBP (bureau of customs and border protection, customs) |
|
Definition
• Major responsibility of customs
Collect duties, taxes and fees
Review import entry forms
• Products not in compliance with FDA/USDA will be seized by customs and only released after written approval |
|
|
Term
|
Definition
Environmental Protection Agency
• Not directly involved in regulation of imported food
• Set pesticide residue standards which both import and domestic products must meet
• Pesticide limits are estimated by the EPA |
|
|
Term
| TTB (alcohol and tobacco tax and trade bureau) |
|
Definition
•Alcohol and Tobacco Tax and Trade Bureau
Must obtain a permit to import alcoholic products
Maintain and staff a business office in the US
Must have a certificate of label approval
Since alcohol is a food must meet FDA requirements too. |
|
|
Term
| NMFS (national marine fisheries service) |
|
Definition
•National Oceanic and Atmospheric Administration
NOAA provides support to both domestic and foreign suppliers
•Sanitation inspection, product grading, process and product inspection
NMFS responsible for protection of living marine resources
• May put restriction on the import of certain marine species |
|
|
Term
| USDA process (Import Safety) |
|
Definition
• Before a firm can export FSIS must determine exporting country has equivalent food safety system (3-5 years)
• If documentation looks acceptable then FSIS conducts on-site audit of the entire meat/poultry regulatory system
• If country passes then added to the eligible import countries
• To maintain approval FSIS
Review documents
On-site food regulatory system audits at least annually
Port-of-entry reinspection
• FSIS inspectors visually check every imported shipment of food
Mainly documentation and labeling
More complete inspection and testing of smaller portion (20% in 1997, 11% in 2007) |
|
|
Term
|
Definition
a. Voluntary action by a manufacture or distributor
b. Done to protect the public from products that could cause health problems or death
c. Purpose is to remove adulterated or misbranded products from commerce |
|
|
Term
|
Definition
o A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
• Presence of pathogens in ready-to-eat meat or poultry products, or the presence of E. coli 0157:H7 in raw ground beef |
|
|
Term
|
Definition
o A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
• Very small amounts of undeclared allergens typically associated with milder human reactions, e.g., wheat or soy or small sized, non-sharp edged foreign material in a meat or poultry product |
|
|
Term
|
Definition
o A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
• Presences of undeclared, generally-recognized as safe, non-allergenic substances, such as excess water in meat or poultry products |
|
|
Term
| How are unsafe products discovered? |
|
Definition
• Company reports potential hazard
• FDA/FSIS testing indicates products are adulterated or misbranded
• Facility inspections reveal the potential for a product recall
• Illnesses reported by State or local public health departments, CDC |
|
|
Term
| Preliminary Steps/Investigation |
|
Definition
• Government contacts
o USDA/FSIS – recall committee
o FDA – district recall coordinator
• Contacting the manufacturer
• Interview consumers
• Collect/analyze food samples
• Collect/verify information about the food
• Document chronology of events
• Recall Submission
o Submit as soon as possible
o Do not wait until all information is collected
• Product information, codes, recalling firm contact, manufacturer, firm responsible for the violation, reason for recall, health hazard assessment, volume of recalled product, distribution pattern, recall strategy |
|
|
Term
| Public Notification FDA/Company |
|
Definition
• Press-release – highest priority, issued promptly
o Should consult FDA/USDA
o Joint press release may be appropriate
• Written notification (customers)
o Flagged/large bold print
• Urgent : food recall
o Product description, copy of label, description of the problem, depth of recall
o Recall instructions should be clear
• Remove product, cease distribution, return product
o Include a customer response card/form
• Provide examples of all communications to FDA/USDA |
|
|
Term
| Effectiveness Checks – FDA |
|
Definition
• Evaluates whether all reasonable efforts have been made to remove or correct a product
• A recall is considered complete after all of the company’s corrective actions are reviewed by FDA/FSIS and deemed appropriate
• Makes sure that the product is destroyed or suitably reconditioned
• Investigates why the product was defective in the first place
• What % of product is usually recovered?
o FDA 36%
USDA 38% |
|
|
Term
|
Definition
• Hazard Analysis Critical Control Points
• Food Safety program designed to prevent, eliminate or reduce biological, chemical and physical hazards from our food supply
• HA – where and how
• CCP – Proof of the control of the process and conditions |
|
|
Term
|
Definition
| • Goal – to enhance the safety of our products by systemically controlling the hazards |
|
|
Term
| A proactive approach to food safety: |
|
Definition
o Identify hazards, determine CCP’s
o Making a plan to control them
o Putting that plan in action and
o Documenting that you did it (it is before the safety issue comes) |
|
|
Term
|
Definition
o Astronauts created something that would not create foodborne illness
o The crumbs in outerspace
o Potential needs to be eliminated completely
o Developed by NASA |
|
|
Term
|
Definition
• Gather knowledge of the food product/process
• Predict what might go wrong (how and where it would occur)
• Selected points in the process to take measurements/observations (control/demonstrated)
• When points are out of control probability of a problem increase |
|
|
Term
|
Definition
|
|
Term
|
Definition
(1970’s)
•Low-acid canned foods and acidified foods (21 CFR 113,114) |
|
|
Term
|
Definition
| 1989) – National Advisory Committee on Microbiological Criteria for Foods “HACCP principles for food production” |
|
|
Term
|
Definition
| (1991) – Codex Alimentarius Committee on Food Hygiene (UN committee) |
|
|
Term
|
Definition
(1996) – “Pathogen Reduction and HACCP” final rule
• SOP’s for sanitation
• Implement HACCP
• Microbiological testing |
|
|
Term
|
Definition
|
|
Term
|
Definition
|
|
Term
| International use of HACCP |
|
Definition
• European Union
• Canada
• Australia
• New Zealand
• Japan |
|
|
Term
|
Definition
• Preventive, not reactive
• HACCP is not a zero-risk system
• It is designed to minimize the risk of food-safety hazards |
|
|
Term
|
Definition
• It is our responsibility as a food manufacturer to ensure that all our foods produced are safe and wholesome
• It is the law. The Federal Food, Drug and Cosmetic Act make it illegal to sell any food that has been adulterated. The USDA –FSIS and FDA have mandated HACCP programs for all meat/poultry, fish and juice products
• It is good business. Can prevent disastrous consequences in terms of lost customers, lawsuits, economic losses and unwanted publicity
• It is a requirement. Some Customers requires all suppliers to have a HACCP Plan in place for every product produced |
|
|
Term
|
Definition
• Systematic approach
• Application of technical and scientific principles
• Involves all levels of personnel
• Results in reduction of foodborne disease and product waste
• Results in increased operational efficiency, profits and consumer confidence |
|
|
Term
|
Definition
• Leadership commitment
• Employee buy-in
• Costs
• Requires proactive thinking
• Burden of proof |
|
|
Term
| Seven Principles of HACCP |
|
Definition
• 1. Conduct Hazard Analysis
• 2. Determine the critical control points (CCPs)
• 3. Establish critical limits
• 4. Monitor each CCP
• 5. Establish corrective actions
• 6. Establish verification procedures
• 7. Establish record-keeping and documentation procedures |
|
|
Term
|
Definition
• Programs that make you more prepared in the HACCP programs
• The concept of HACCP must be supported by a solid foundation
• Prerequisite programs set the stage and provide on-going support for HACCP
• Without Prerequisite programs HACCP would be in-effective
• Intended to keep low-risk potential hazards from having an impact on food safety
• Provide the basic environment and operating conditions necessary to product safe and wholesome food
• Many are based on GMP’s
• Must be written, monitored, reviewed and verified
• Some are required by regulations |
|
|
Term
|
Definition
o Indirect food safety issues
o More general across the facility
o Failures seldom result in food safety concen |
|
|
Term
|
Definition
o Deal solely with food safety issues
o Specific to a product, line, plant, etc,
o Deviations will result in unacceptable conditions |
|
|
Term
| • How to establish prerequisite programs |
|
Definition
o Requires commitment from management
o Documented – systematic and objective
o Employee training – understanding verified and reviewed
o Verification – reviewed on a regular basis
o Resources – equipment, tools, systems, personnel |
|
|
Term
|
Definition
o HACCP coordinator
o Multidisciplinary unit
• Engineering
• Maintenance
• QA
• Microbiology
• Production
• Regulatory
• Product development |
|
|
Term
| Principle #1 Hazard Analysis |
|
Definition
o Hazard analysis of food from growing, harvesting, production, distribution and consumption
o Knowledge of hazards associated with a food product, its ingredients and the production process is needed in order to properly assess the hazards |
|
|
Term
|
Definition
| A biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control |
|
|
Term
| In HACCP “hazards” refer to |
|
Definition
conditions or contaminants in food that can cause illness or injury. It does not refer to undesirable conditions or contaminants such as:
•Insects, hair, filth, spoilage, economic fraud, and violations of regulatory food standards not directly related to safety
•Biological: E. coli, Salmonella, Listeria, Staph, C. botlinum
•Chemcial: acids, sanitizers, pesticides, toxins, allergens
Physical: metal, wood, glass, plastic, stone |
|
|
Term
|
Definition
1. Hazard identification
assemble list of all ingredients, processes and packaging materials
2. Hazard Evaluation
likelihood and severity |
|
|
Term
| Examples of biological hazard controls |
|
Definition
Time/temperature control
Heat/cooking processes
Cooling and freezing
Fermentation and/or pH control
Addition of salt or other preservatives
Drying
Raw material source control |
|
|
Term
| Examples of chemical hazard controls |
|
Definition
Raw material source control
• Vendor certification
• Raw material testing
Production control
• Use only approved chemicals
• Proper use of food additives
• Train employees who handle chemicals
Labeling control – ingredients, allergens |
|
|
Term
| Examples of physical hazard controls: |
|
Definition
Raw material source control
• Vendor certification
• Raw material testing
• Visual examination of incoming raw materials and supplies
Production control
• Use magnets and metal detectors |
|
|
Term
| Principle #2 Critical Control Points |
|
Definition
o The HACCP team determines Critical Control Points based on Hazard Analysis
• The hazard is identified
• Control measures are considered |
|
|
Term
|
Definition
| a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level hazards can be controlled |
|
|
Term
|
Definition
| : any step at which a biological, physical, or chemical factors can be controlled |
|
|
Term
|
Definition
• The HACCP team should utilize the decision tree to evaluate each point where significant hazards can be prevented, eliminated or reduced to acceptable levels
• Subsequent steps in the process may be more effective at controlling a hazard |
|
|
Term
|
Definition
| Establish Critical Limits |
|
|
Term
|
Definition
• A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce the hazard to an acceptable level
• For each CCP a critical limit is established to signify whether a CCP is “in” or “out” of control |
|
|
Term
| Exceeding critical limit indicates |
|
Definition
• Direct health hazard could occur
• Product not produced under condition which would assure safety |
|
|
Term
| Examples of critical limits |
|
Definition
| • Time, temperature, pH, moisture, salt concentration, line speed, water activity, titratable acid, physical dimensions, and preservative concentration |
|
|
Term
| Steps in establishing critical limits |
|
Definition
• For each critical control point
Determine if there is a regulatory critical limit
If there is no regulatory limit, determine critical limit based on scientific/technical data
Document basis/justification for establishing critical limits for validation |
|
|
Term
|
Definition
• Monitoring for pathogens
Hazard – presence of pathogens
CCP – fryer
Critical limits – no pathogens detected |
|
|
Term
|
Definition
• Controlling Internal Temperature
Hazard – presence of pathogens
CCP-fryer
Critical limits – minimum internal temperature of 150 F for one minute |
|
|
Term
|
Definition
• Controlling Factors that affect internal temperature
Hazard – presence of pathogens
CCP – fryer
Critical limit – minimum fryer temperature of 350F
Critical Limit – maximum patty thickness of ¼ inch
Critical limit – minimum cook time in the oil of one minute |
|
|
Term
|
Definition
| Establish Monitoring Procedures |
|
|
Term
|
Definition
| Planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification |
|
|
Term
|
Definition
|
|
Term
|
Definition
: procedure to be followed when a CCP-CL deviation occurs
A corrective action required whenever a CCP – CL deviation occurs |
|
|
Term
|
Definition
| Establish Verification Procedures |
|
|
Term
|
Definition
| Establish procedures to show that the overall system and specific evaluation tools are working |
|
|
Term
|
Definition
| Activities other than monitoring that determine the validity of the HACCP plan and that verify the system is operating according to the plan |
|
|
Term
|
Definition
Validation: determine if the HACCP plan s working
On-going Verification: Determine if operations are in compliance with HACCP plan (Has HACCP been implemented properly) |
|
|
Term
|
Definition
| the element of verification focused on collecting and evaluation of scientific and technical information to determine if the HACCP plan when properly implemented will effectively control the hazards |
|
|
Term
|
Definition
| Prerequisite programs, CCP's, HACCP plan |
|
|
Term
| CCP Verification Activities |
|
Definition
Calibration of monitoring devices
Calibration of record review
Targeted sampling and testing
CCP record Review |
|
|
Term
|
Definition
Check product description and flow diagrams
Check that CCP's are monitored correctly
Check that CL are being met
Check that corrective action records are complete |
|
|
Term
|
Definition
|
|
Term
|
Definition
| written evidence through which a act is documented |
|
|
Term
|
Definition
| Assures that this written evidence is available for review and is maintained for the required length of time |
|
|
Term
|
Definition
Summary of Hazard Analysis
HACCP Plan
Support Documents
Daily operational Records |
|
|
Term
|
Definition
Refrigerated product: at least one year
Frozen, preserved or shelf stable products: At least 2 years
6 moths on site |
|
|
Term
|
Definition
| Keep it current Keep it simple Make it easy |
|
|
