ASCI 415 Final

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What are the 9 processing categories in 9CFR 417.2?

- Slaughter - All species (Ex: no example) - Raw Product - ground (Ex:ground pork/beef/poultry, fresh sausages, meat & poultry patties, whole hot sausage) - Raw Product - not ground (Ex: primal cuts, tenderized cuts w/ no microbial inhibitors (pork tenderloin with solution), boneless cuts, seasoned cuts & parts) - Thermally processed - commercially sterile (Ex: canned products such as vienna sausage/lard, meal ready to eat, low acid canned foods, hermetically sealed products such as dinners or entrees) - Not heat treated - shelf table (Ex: dry cured pork, prosciutto, pickled pigs' feet & ears, country hams, pepperoni, dry salami, summer sausage - Heat treated-shelf stable (Ex: meat & poultry jerky, popped pork skins, snack sticks, meat base soups) - Fully cooked-not shelf stable (Ex: hams, hot dogs, wieners, cooked roast beef, cooked corned beef, prepared dinners, pastrami, turkey bacon, meat and poultry salads, meat and poultry loaves, poultry sausage) - Heat treated, but not fully cooked-not shelf stable (Ex: bacon, smoked sausages, partially cooked patties, products with batter and breading set but not fully cooked, low temperature rendered products) Nitrate (No3) to cure the product & inhibit growth of clostridium - Product with secondary inhibitors-not shelf stable (Ex: bacon, smoked sausages, partially cooked patties, products with batter and breading set but not fully cooked, low temperature rendered products)

How you will establish a Critical Limit?

- The critical limit is usually a measure such as time, temperature, water activity (Aw), pH, weight, or some other measure that is based on scientific literature and/or regulatory standards. The HACCP team will describe monitoring procedures for the measurement of the critical limit at each critical control point. THE CRITICAL LIMITS SHOULD BE: - Observable: Achievement of and any subsequent changes in the critical limits during processing can be detected. - Measurable: Achievement of the critical limits can be confirmed by measurement and any deviations quantified. - Subject to "real time" monitoring: Any observations and measurements must be capable of being made whilst processing is in progress to allow appropriate corrective actions to be made in good time. - Critical limits may be chemical, physical or even procedural in nature depending on the type of hazard that is subject to control.

Know the major events leading to the formation of the USDA and FDA

- USDA was founded by President Lincoln in 1862, responsible for the safety of meat, poultry, and non-shelled egg products - FDA was founded in 1906, responsible for passing the food and drug act, separate from USDA since its under the Department of Health and Human Services - Oversees all other foods like shelled eggs, wild game meats, fish, seafood, drugs, cosmetics, medical devices - Publishment of the Jungle by Upton Sinclair led to a focus on controlling poor working conditions and regulating food processing factories more closely

Remember the retention timeline for the FDA and the USDA records

1 year: slaughter activities and refrigerated foods 2 years: frozen, preserved, and shelf stable foods

What was 'the Jungle' book about?

1906 - Written by Upton Sinclair, meant to expose the appalling work conditions in Chicago Meat Packing Industry

Remember the temperature danger zone

40ºF-140ºF

What are three alternatives of L. monocytogenes control plan?

Alternative I - Post-lethality treatment and an antimicrobial agent Alternative II - Post-lethality treatment or an antimicrobial agent Alternative III - Sanitation measures only

When is verification of prerequisite programs done?

Annual review of written procedures and quality systems audit reports Prereq programs also need calibration of all detection and measurement instruments

FDA and USDAs regulation for number of CCPs that are needed in the food processing industry.

Any HACCP plan must contain at least 1 CCP But acid/low-acid canned foods do not require any biological CCP's (as low acid will kill most bacteria and canning requires 12 log reduction

Preliminary tasks to develop HACCP

Assemble HACCP Team Product Description Identify Intended Use and Consumers of Food Develop Flow Diagram Verify Flow Diagram

Types of monitoring activities

At CCPs, there can be visual observations and measurements of parameters [time, temperature, pH, etc.] Take into consideration the accuracy of the measurements and tests

Know some sources of biological hazards

Beef - salmonella, e. colio157:h7, c. perfringens poultry - salmonella, campylobacter, c. perfringens veggies - listeria, botulinum, slamonella fruits- vibrio, botulinum, parasites, viruses eggs - salmonella juice - e. coli o157, salmonella, cryptosporidium spices - salmonella and clostridium

Remember cooking temperatures for beef, chicken, pork, eggs, and vegetables

Beef and pork - 145ºF for 15s Poultry - 165ºF for 15s Eggs - 155ºF for holding and 145ºF for order, 15s Vegetables - 135ºF

Remember some cleaners used in the industry

Chlorine containing compounds [corrosive for bacteria] - Na or Ca-hypochlorite - gaseous Cl- Aldehydes [corrosive for bacteria] - formaldehyde - phenols - alcohols - acids QUATS [not good for spores, affects cell walls, odorless] oxygen releasing substrates [good for spores and viruses. can be corrosive if more than 1%] - peroxide compounds -per-acetic acid,

Remember top 5 food-germ pairs causing outbreaks (ex. of 2015 analysis is in your lecture slide)

Ciguatoxin + fish Scombroid toxin/Histamine + fish Salmonella + chicken Salmonella + pork Campylobacter + dairy

Know 7 Principles of HACCP

Conduct hazard analysis determine critical control points establish critical limits establish monitoring procedures establish corrective actions establish verification procedures establish documentation and record keeping

Continuous vs. Discontinuous monitoring

Continuous - Used when there is a variation, spikes or drift in critical limit may go unnoticed or when the critical limit is close to operating limit Example: In-line measurement of pH Discontinuous - Used when continuous monitoring is impractical, variability is low, and operating parameter is far away from the critical limit. Example: minimum internal cook temperature of a product

Types of monitoring procedure - Continuous vs. noncontinuous

Continuous = a type of monitoring procedure that is always occurring or monitoring the step/process/CCP (ie. thermometers) - preferred method Noncontinuous = type of monitoring procedure that occurs and measures periodically

Control point vs. Critical control point

Control points are any steps where biological, physical, or chemical factors can be controlled Critical control points are steps where control can be applied and IT IS ESSENTIAL to prevent or eliminate a food safety hazard or reduce it to an acceptable level Ask the question : are we doing something to kill/eliminate/reduce something

Definition of Critical Limit and some examples of parameters that may be critical limits.

Critical Limit → A criteria that separates acceptability from unacceptability. ALSO.. they are the max and/or min value to which bio, chem, or phys hazard must be controlled at a CCP to prevent/eliminate hazard establishes what safe and unsafe operating conditions are at a CCP

Critical limit vs. Operating limit

Critical Limit: the max and/or min value to which biological, chemical, or physical hazards must be controlled at a CCP to prevent/eliminate hazards. It establishes what are the safe and unsafe operating conditions at a CCP. (Exs. of critical limits: pH, Temp., time, moisture level, etc.) THIS IS REQUIRED Operating limits : parameters more stringent than those necessary for safety and are established for reasons other than food safety (to avoid violations of critical limits). They are set by the processing plant based upon operating data; and exceed regulatory requirements and recommendations. THIS IS OPTIONAL

Two NASA concerns?

Crumbs and water droplets Microbiological safety

Definition and purpose of taking corrective actions

DEFINITION- a corrective action consists of: acting immediately to prevent adulterated food from entering commerce - identifying and eliminating the cause of deviation bringing CCP under control establish measures to prevent recurrence PURPOSE- The goals of a Corrective Action Plan are to: - Establish a system that allows and promotes rapid response to deviations from a critical limit; - Correct and eliminate the cause of the deviation and restore process control; - Maintain accurate documentation and records; and - Identify affected product and determine appropriate disposition

What is the record keeping requirement for meat and poultry SSOPs document?

Daily SSOP records for implementation, monitoring, and corrective action are needed They are initialed and dated by the supervisor Records are kept on-site for at least 48 hours and are then retained offsite for at least 6 months

What is a CCP? And purpose of doing a CCP assessment?

Definition: A step at which control is essential to either prevent/eliminate the hazard to reduce the hazard to an acceptable level CCP assessment is necessary to prevent hazards that are reasonably likely to occur from harming consumers via sickness/illnesses.

Definition and purpose of the monitoring procedure

Definition; a planned sequence of observations or measurements that are recorded to determine if a CCP is under control Purpose is to track the trends in the operation to have corrective actions before a deviation occurs, to determine deviations at the CCP, and provide written documentation for verification

Remember three elements of corrective action.

Determine and correct the cause of non-compliance Determine the disposition of the non-compliant product that poses a food safety risk Record the corrective action

Steps in setting the critical limit.

Determine food safety parameter (time, temperature, pH, flow rate, etc.) that must be met at each CCP Determine proper standard that will prevent eliminate or reduce the occurrence of the food safety hazard to an acceptable level Critical limits must satisfy the capabilities of the manufacturer Continually monitor the process vs. periodic checks of product temperature Critical limits established by tests and experiments Heat penetration: heating/cooling rate Temperature distribution Thermal death time for specific pathogens (D-values) Inoculated pack/microbial challenge studies

What does Codex Alimentarius committee do?

Develop HACCP guidelines for international trade

What are some of the procedures for assessing SSOP effectiveness?

Develop procedures for assessing SSOP effectiveness Organoleptic / sensory: sight, feel smell Chemical: sanitizer level Microbial: swabbing, culturing for pathogens or indicator organisms Method, frequency and record-keeping processes associated with monitoring Pre-operational monitoring Describe, evaluate and document cleaning effectiveness for product contact surfaces, equipment and utensils before start-up Operational monitoring Describe, evaluate and document adherence to SSOP's for direct product contamination and employee practices during production, including appropriate corrective action. Record retention including corrective actions Retained for 48 h on-site and at least 6 months off-site

What should constitute a HACCP team?

Engineering/Operation Specialist Production Supervisor Sanitation Specialist Team Leader Quality Assurance Supervisor

How FDA and USDA regulate sanitation requirement?

FDA recommends written SSOP's for FISH & SEAFOOD (not under USDA), while USDA mandates SSOP's for MEAT & POULTRY processors. Failure = legal or criminal action.

Who has the regulatory authority over meat and poultry products?

FSIS which is a part of USDA

Is there any FDA applications of HACCP? Some examples

Fish/seafood and juice

What are the characteristics of food supporting microbial growth - Hint. FATTOM

Food Acidity - between 4.6-7.5 pH Time Temperature [40-140ºF] Oxygen level Moisture [bacteria is 0.95-0.88, yeast is 0.88-0.80, mold is < 0.80]

What were two important laws passed on 1906?

Food and Drug Act = FDA responsible for all other foods Meat Inspection Act = required FSIS inspection of production plants

Foodborne infection vs. intoxication

Foodborne Infection Person consumes a food that contains a bacteria, virus, prion, or parasite then multiplies in the body and causes illness Foodborne Intoxication Person consumes a food that contains a toxin produced by bacteria (botulinum toxin or staphylococcal enterotoxin) or naturally found in some plants (poisonous mushrooms) or molds (mycotoxin)

What is HACCP and explain three different types of hazards?

HACCP stands for Hazard Analysis and Critical Control Points. The most effective system to ensure food safety is a common-sense approach based on prevention rather than inspection. The three different hazards are biological, physical, and chemical. Examples are: Biological - Listeria and Salmonella Physical - Metal shards and broken glass Chemical - Bacterial toxins and Peroxide cleaners.

Ways to prevent physical, chemical and biological hazards from entering the commerce.

Harvesting, growing practices; prevention of cross contamination separating raw from cooked; separate veggies from meats, clean multi-shared surfaces, keep seafood harvest somewhere else, etc

What are some of the methods that can kill or control the growth of biological hazards?

Heat Hot water, steam vacuuming, steam pasteurization pH Low pH (Acidic) High pH (Basic) Oxidation Clorox, Purex, chlorine based products Others Irradiation, UV light, high pressure

How you define a 'hurdle' technology?

Hurdle technology = combination of factors/steps to prevent/eliminate bacterial growth (ie. heating, chilling, preservatives, drying, etc.)

Three principles of the original HACCP system

Identify and Assess Hazards Determine Critical Control Points Establish Systems to Monitor

What are the general Sanitation practices?

Includes the following: - Cleaning of equipment - Cleaning the facility - Personnel practices - Equipment design and operation - Pest control - Warehousing practices - Addressed in FDA and USDA regulations - FDA recommends written SSOP's for fish and seafood - USDA mandates SSOP's for meat and poultry processors - Failure to comply with SSOP's can lead to legal or criminal action - Successful sanitation programs - Pro-active approach - Employee participation in developing SSOP's - Ongoing employee education - Delegation of responsibilities - Management commitment - Monitoring procedures - Record-keeping for verification through inspections and audits - Sanitation steps - Locking(Lock out tag out) - Washing - Pre-rinse(hot water) - Soap and scrub - Thorough rinse hot water - Looking, touching, and smelling - Sanitizer and cool water - Using quaternary ammonium compound

What is a prerequisite program? List 2-3 programs and detail how the programs relate to HACCP

It is a Foundational Program. Good Manufacturing Practices (GMPs) Sanitation Standard Operating Procedures (SSOPs) Training (1 out of 12 on the list)

When is revalidation done and specific points to be looked at?

Known as reassessment by USDA and FDA Conducted at least annually on the entire HACCP plan Look at the prereq programs, raw materials, equipment, employee practices, product formulation, shelf-life, and packaging

What is a bacterial 'log reduction'?

Log reduction stands for a 10-fold, one decimal, or 90% reduction in numbers of recoverable bacteria The 5-log reduction is the value used for some food safety standards and refers to the reduction in the number of microorganisms by 100,000-fold

Know some basic information about the major foodborne pathogens such as where they are found, how they grow, their characteristics, and how this affects their survival in our foods.

Major foodborne pathogens (biological hazards): Salmonella Found: poultry ground chicken/turkey products, raw chicken breasts/legs/wings, beef, pork, leafy greens/vegetables, fruits, dairy Grow: optimal growth = 37C pH = 6.7-7.8 Characteristics: Survival effect in foods: in dry foods and refrigerated foods for prolonged periods of time Major foodborne pathogens: Campylobacter Found: only in chicken (hard to find in other meats) dairy/milk Grow: Characteristics: Survival effect in foods: Major foodborne pathogens: E. Coli 0157:H7 (026, 045, 0103, 0111, 0121, & 0145) Shiga-Toxin Found: beef, vegetables, fruits Grow: Characteristics: Survival effect in foods: Major foodborne pathogens: Listeria monocytogenes Found: beef, vegetables, fruits, dairy/milk Grow: Characteristics: Survival effect in foods:

Where was the first meat application of HACCP?

McDonalds

What are prions?

Modified form of a normal protein, associated with BSE or bovine spongiform encephalopathy [mad cow disease]

Important facts of record keeping and documentation procedure.

Must Include: Form title, • Firm name and location, • Time and date, • Product identification (including product type, package size, processing line and product code, where applicable), • Actual observation or measurement, • Critical limits, • Operator's signature or initials, • Reviewer's signature or initials, and • Date of review. Benefits food safety, equipment performance (prevent deviations) Reviewers In house, outside consultants, customers, regulators

Critical limits

NACMCF - one or more prescribed tolerances that must be met to ensure that CCP is controlled FDA - max or min value where a hazard must be controlled at CCP to prevent food safety hazard FSIS - CLs at a minimum are designed to ensure that targets an performance standards are met which are established by FSIS codex - criterion that separates acceptability from unacceptability

Seven principles of HACCP were created on

November 1989 with NACMCF

Remember FDAs 8 common Allergen

Peanuts Tree nuts Eggs Milk/Dairy Soy Wheat Fish Shellfish

Know some examples of each types of hazards

Physical Needles, wood, soil, glass, stones Chemical Non-Food Indirect processing additives (boiler water additives, peeling aids, defoaming agents) Building or equipment maintenance chemicals (grease, mineral oil) Cleaning, sanitizing, or pest control chemicals (laundry detergent, highly conc. sanitizer) Storage and shipment chemicals In-Food Toxins, heavy metals, allergens Antibiotics, hormones, pesticides Packaging materials Direct processing additives Flavor enhancers, color additives, thickeners Curing ingredients (Pink Cure), allergens, stabilizers Microbiological processing/packaging aids Biological Microorganisms such as bacteria, viruses, yeasts, molds, and parasites

Percentage of incidents/illnesses caused by physical, chemical and biological hazards.

Physical - 2% Chemical - 4% Biological - 94%

Pre-operational vs. Operational sanitation

Pre-operational = ensures that facilities, equipment and utensils are free from soil, tissue debris, chemicals, and other hazards before starting Develop detailed written procedures for daily cleaning of product contact surfaces, equipment, and facilities Describe equipment disassembly and reassembly after cleaning/sanitizing Sanitizer approved for intended use and prepared according to manufacturer Use acceptable cleaning techniques Operational = written procedures for maintaining sanitation during product preparation, storage, and handling Prevent direct product contamination and adulteration during operations Develop procedures for cleaning, sanitizing, and disinfecting equipment and utensils during production, breaks, between shifts and at mid-shift cleaning Enforce proper employee hygiene including personal hygiene, cleanliness of outer garments and globes, hair restraints, handwashing, and health Develop plans for handling product in raw and cooked areas

Prerequisite vs. HACCP

Prerequisite Programs - Not required - Deviation is unlikely to harm anyone - Generally managed in quality programs - Difficult to associate failure with particular lot - Broad programs and multiple lines HACCP - Required by USDA/FSIS - Deviation can result in serious consequences - Only in food safety programs - Easy to associate failure with certain lot - Specific product and line

What are some of the benefits and drawbacks on implementing HACCP?

Production companies face heavier responsibilities; shifts from USDA to the plants needing to maintain the records Employee participation is needed; requires effort from entire team and departments Costs; remodelling and replacing old equipment, having sampling materials and validation processes

What are the 5 steps in establishing prerequisite programs?

Step 1. Commitment from management Time Resources (money$ how many employees can work & maintain) Step 2. Documentation for compliance What procedures are performed? (SSOP -> chemical concentration Quad) How often? (once every 4 days) By whom? Action if procedures aren't performed as written? Action if procedures don't produce the expected outcome? Documentation (written prerequisite plan) Include Standard Operating Procedures (SOP's): Objectives, Procedures, Practices, Job Description/requirements Step 3. Employee Training Continuous education (by inspector) Must understand importance of assigned duties Periodic verification of employee performance (observed by supervisor/lead) Step 4. Verification Verify all SOP's related to every prerequisite program Conducted by someone other than the person assigned to complete the task Appropriate monitoring & record-keeping Step 5. Resources Updating/adapting equipment Monitoring systems

What are 4 different types of HACCP records?

Summary of the hazard analysis The HACCP plan Supporting documentation Daily operational records

What is a food safety modernization act? When it was signed into law?

The Food Safety Modernization (FSMA) protects public safety by requiring mandatory food safety training and risk prevention controls for all food processors. Full adoption of HACCP approach for assuring the safety of food came in 2011.

Why is it important to have a sound foundation of prerequisite programs prior to implementing the HACCP?

The purpose of prerequisite programs is to assure proper function of HACCP in producing safe foods, it simplifies the development and maintenance of HACCP plan, an essential component of operations We need the support of these programs so HACCP can function; helps create a less headache for FSMA, these pretty much make things easier for HACCP to do its jobs

What is the Purpose of conducting a hazard analysis?

To identify hazards and associated control measures Identify any needed modifications to product or process to better ensure product safety Provide a basis for termining CCPs in principle 2

What are the differences between verification, validation, and calibration procedures?

Verification- based on Expert advice / scientific studies and In-plant observations, measurements and evaluations. Determine if the HACCP system is functioning according to the plan Validation- Validation is "the element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards". Calibration- Ensure accuracy of measurements. Equipment is calibrated or replaced if it is not within tolerance.

Why we are keeping records in the food industry?

We keep records and documents of procedures and processes in HACCP Helps ensure there is adherence to critical limits Monitoring is happening for activities Regulatory compliance audits and compliance with HACCP plan Assists in identifying products involved in recalls

What are the four steps in establishing monitoring procedures?

What attribute will be monitored at the CCP to control the identified hazard? How will the attribute be monitored? (Procedures) When will it be monitored? (Frequency) Who will perform the monitoring procedures?

Accuracy vs. Precision

accuracy is a measure of how close you are to your target value. precision is a measure of how close your data are when you repeat the measurement.

What are some of the types of independent checks?

internal cook temperatures second person performing same task microbial testing

Remember to draw a bacterial growth curve and explain each component

lag, log, stationary, death

Organisms of concern with poultry, beef, pork, milk, vegetables

microorganisms of concern in beef/fruits/veggies: salmonella and e coli o157:h7 microorganisms of concern in pork: salmonella and Clostridium perfringens microorganisms of concern in poultry/dairy: salmonella and campylobacter


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