HACCP

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•Monitoring Definition (NACMCF):

"*A planned sequence of observations* or measurements to assess *whether a CCP is under control* and *produce an accurate record* for future use in verification"

"test and hold" within the beef industry

"N-60" Sampling Method

1996: National Residue Program's purpose...

"is intended to provide Verification of residue control by HACCP Systems."

Adequate Ventilation

(1) Minimize *odors, vapors*, steam and noxious fumes in food areas (2) Locate and operate *fans to minimize contamination* of food, food-contact surfaces and packaging material (3) *Screening* or other protection against *pests*

proper hygienic practices

(1) Outer garments to protect food from contamination (2) Maintain adequate personal cleanliness (3) Thorough *washing and sanitizing of hands* in an adequate wash facility before starting work, after each absence from the work station and at any other time when soiled (5) *Maintain* impermeable *gloves* in an intact, clean and sanitary condition (6) *Wear hair nets*, caps, snoods, or other hair restraints as appropriate (7) Store *clothing away* from food, equipment and utensils (8) *No eating*, gum chewing, beverage drinking or smoking in areas exposed to food, equipment or utensils (9) Remove (or cover) unsecured jewelry (10) Take *additional precautions* as needed to prevent contamination of food by perspiration, hair, cosmetics, tobacco, chemicals and topical medicines

Facility Construction and Design - *Protect food* in outdoor bulk storage vessels

(1) Protective *coverings* (2) Eliminate *harborages* for pests (3) Regular checks for pests (4) Skimming vessels as necessary

Construction design:

(1) Readily cleanable materials constructed for *easy cleaning* of walls, floors, and ceilings (2) *Prevent drip/condensate* on fixtures, ducts and pipes from contaminating food, food-contact surfaces and food packaging materials (3) *Provide aisles/working spaces* between equipment and walls for proper cleaning/ sanitation

Current Good Manufacturing Practices (cGMP's) - definition of *adulterated food*

(Food, Drug and Cosmetic Act) - Food has been manufactured under such conditions that are *unfit for human consumption*

revalidation is termed...

*"reassessment"* by USDA and FDA

______________ spice imports contaminated with insect parts, whole insects, rodent hairs and other things

*12% of U.S.*

_________________ spices hold bacteria and harmful chemicals

*4 out of 10*

Acidified foods at pH <

*4.6*

verification of prerequisite programs

*Annual review* of written procedures and quality systems audit reports; Prerequisite programs (PRP) for *calibration* of all detection and measurement *instruments* (also under HACCP plan for CCPs)

critical limits are used to...

*Determine if the control measure at the CCP is "in" or "out" of control*

step two of determining CCPs with a decision tree

*Determine* if the step is a CP or CCP

validating the HACCP plan

*Done by the HACCP* team during initial implementation of the HACCP plan

step one of determining CCPs with a decision tree

*Evaluate each step* where food safety hazards can be prevented, eliminated or reduced to acceptable levels

Alternatives to decision tree:

*Experience and knowledge* of the process and existing control measures

building and facilities cGMPs

*Grounds: protect against food contamination* -Proper equipment storage -Removal of litter and waste -Weed / grass cutting -Proper maintenance of roads, yards and parking lots -Adequate *drainage* to prevent seepage, foot-borne filth and *pest breeding* areas -*Adequate waste* treatment and disposal

Focused solely on _____________- not product quality

*HAZARDS*

Jack in the Box outbreak outcome

*Jumpstarted the implementation of HACCP* principles in the ground beef industry

first application of HACCP: ground beef

*McDonald* Corporation's ground beef patty producers worked with *Colorado State University* to develop and teach a HACCP plan to beef packers

Industrial Cooking Challenges

*Must ensure proper cooking and cooling to maintain product quality and safety*! • Food must be *cooked* to proper internal temperature. • Cooked food needs to be *cooled* down to the right temperature within acceptable time frame. • Frozen food must be *defrosted* to the correct temperature within acceptable time frame. • *Create, maintain, and store temperature/time records* for inspectors and management • *Fully automated records* of temperature/time data for cooking, tempering, and defrosting processes. • Cloud-based log of all data for instant monitoring access and report generation. • *Automatic alerts*

Setting Critical Limits

*Non-government food safety criteria* •Processing authorities/experts •Scientific literature •Trade associations •University extension •In-plant studies / research •Equipment manufacturers

Human Food Manufacturing Areas

*Not used to* manufacture non-human food- grade animal feed

discontinuous monitoring

*Periodic measurements* or observations

Meat and Poultry Products (9 CFR 308 and 381) Provide criteria for complying with provisions of the *Federal Meat Inspection Act* and the...

*Poultry Products Inspection Act*

Reassessment (Revalidation) -

*Response to situations* that may affect the effectiveness of the HACCP system.

February 2016, The USDA - FSIS has announced new pathogen reduction performance standards for...

*Salmonella and Campylobacter in ground chicken and turkey products, plus raw chicken breasts, legs and wings*

step three of determining CCPs with a decision tree

*Summarize* results and add to the HACCP plan

record definition

*Written evidence* that documents a task

Instruments for measuring, regulating and maintaining temperature, pH, acidity, aw, or other parameters must be...

*accurate and adequately maintained*

tolerances for physical hazards established by FDA in Compliance Policy Guide, Section 555.425, "Foods - Adulteration Involving Hard or Sharp Foreign Objects"; Classifies a product that is ready-to-eat as being adulterated if it contains a hard or sharp foreign object that measure 7 mm (0.28 in) to 25 mm (0.98 in) in length. (Under 7 mm is a hazard if intended for children or the elderly). note this regulation is not for...

*aesthetically unpleasing* objects: For example: Strands of hair, thread, paper etc

Principles of HACCP can be applied to...

*all phases of food production*, from basic agriculture to food preparation and/or processing

*All records* generated from the equipment should be *reviewed* and the establishment should...

*assess* the potential *impact on the safety of products* produced from the last acceptable check

FDA and USDA regulate that any HACCP plan must contain...

*at least 1 CCP*

revalidation is conducted...

*at least annually* on the entire HACCP plan

Results from decision tree can sometimes defy...

*common sense*

corrective actions are required for...

*every CCP*

HACCP is Applicable from...

*farm-to-fork*

FDA recommends written SSOP's for...

*fish and seafood*

record-keeping and documentation Focus only on...

*food safety*

Under FDA, HACCP came to...

*juice and seafood*

The method of *cooking and the temperature* to which products are cooked significantly affect the...

*lethality of the cooking process*, and the overall safety of the product.

1996: Final Rule announced by FSIS-USDA

*list four essential elements* to reduce the contamination of meat & poultry and the risk of foodborne illness

USDA mandates SSOP's for...

*meat and poultry processors*

Minimize potential for ___________________ in all manufacturing operations including packaging and storage

*microbial growth*

Microbiological sampling and testing are essential but...

*never appropriate* monitoring procedures

record-keeping and documentation provide a mechanism to...

*notice patterns* and identify *potential problems*

Record the information at the time it is...

*observed* or measured

validation/verification is...

*piecing together* the entire HACCP "puzzle"

Identification of CCP's based on _____________________ for controlling hazards

*previous hazard analysis*

we must prove that the product is _________ (critical control point - monitoring and verification)

*safe*

Opinions will differ on ______________________ of occurrence; outside consultants are used

*severity and likelihood*

Production and Process Controls compliance verified by any effective analytical method including a...

*supplier's guarantee or certification*

Records must be...

*timed, dated, and signed/initialed* by plant personnel making the entry

record-keeping and documentation are a means of...

*tracing the history* of ingredients and products

Maintain __________________- of discussion

*written record*

revalidation - end result

- *A report* detailing the findings - *Replaces* out-of-date versions of the HACCP plan - A report maintained *as part of HACCP record*

Implementation of the HACCP Plan requires...

- *Commitment* from top management - List *HACCP coordinator and team* responsible for developing, implementing and maintaining the HACCP system - *Initiate product teams* to develop HACCP plans for specific products (requires training) - *Develop timeline* of activities for HACCP plan development and implementation

record-keeping procedures: USDA requirements

- *Date and time* of activity - Date, time, *sign/initial* each data entry - *Processing information* entered when observed - *Reviewer's signature* and date of review

hazard evaluation

- *Decide what hazards* must be included in the HACCP plan based on: *severity* and *likelihood* of occurrence

Qualifications for monitoring

- *Educated* about the importance of accurately recording and reporting unbiased results - Adequately trained to: perform monitoring, make process adjustments, initiate corrective actions, maintain records

inspectors jobs:

- *Ensure SSOP and HACCP plans* are within regulatory requirements - *Verify plants* follow SSOP, HACCP, and micro testing procedures correctly - *Write up* Non-compliance Records (NRs) to document deviations from regulation - *Take needed action* when a plant is non complying with regulation requirements

verification by regulatory agencies

- *Industry*: Develop and implement HACCP - *Regulatory Agencies*: Determine if the HACCP plan is effective and being followed?

Other Uses For Monitoring

- *Make adjustments before a deviation* in critical limits occurs - *Review records for trends* that could adversely impact future product safety (Recalibrating instruments, Repairing/replacing equipment, Altering processing procedures)

revalidation - questions to ask

- *New hazards* not addressed in HACCP plan - CCPs and control measures *still appropriate* - Critical limits *still adequate* - Monitoring, corrective action and record-keeping *appropriate*

three areas of verification

- *Prerequisite* programs - *CCPs*: calibration, monitoring / corrective action records, independent checks - *HACCP plan*

Drawbacks of HACCP

- *Production companies' responsibility* (Shift from USDA monitoring to the plants needing to maintain records themselves) - *Employee participation* (Requires effort from the entire team, from all shifts and departments) - *Costs* (Remodeling, Replacing old equipment, Sampling materials, Validation, etc.)

Considerations when conducting a hazard analysis

- *Raw materials and ingredients* during storage, processing, product storage, distribution and final preparation - *A thorough hazard analysis* is the KEY to preparing an effective HACCP plan

Maintenance of the HACCP Plan requires...

- *Regularly* scheduled verification activities - HACCP plan *updated* and revised as needed - *Proper training* and importance of individual roles in maintaining effectiveness

Maintenance of the HACCP Plan

- *Regularly* scheduled verification activities - HACCP plan *updated and revised* as needed - *Proper training* and importance of individual roles in maintaining effectiveness

CORRECTIVE ACTION RECORDS

- *Required by FDA and USDA* and open to review - *Reason* action was taken - Reasoning *behind disposition* (testing sometimes required) - *Number of units* and product codes affected - *Method of disposal*

Developing SSOP's for Fish and Seafood - required monitoring:

- *Safety of water and ice* in contract with food - Condition and cleanliness of food contact surfaces including utensils, gloves and outer garments - prevent *cross contamination from unsanitary objects* to food (and items coming in contact with food) - prevent cross-contamination *between raw and cooked product* - adequate *hand washing*, hand sanitizing and toilet facilities - *protect food*, packaging materials and food contact surfaces from physical, chemical and biological adulterants - *proper labeling*, storage and use of toxic compounds - control of *employee health*

Early Uses of HACCP

- 1973 - *Training of FDA inspectors* in the element of HACCP and *instituted HACCP inspections* of food plants - Numerous *conferences and sessions* on HACCP including symposium at IFT 1974 - 1970's - *Low acid canning* was first to have the concept of HACCP under FDA. - Late 1970's and 1985 - Decreased interest except for a few large companies (Pillsbury, del Monte). - On its own, *Pillsbury implemented HACCP* at all its facilities by 1974

Codex Alimentarius Committee on Food Hygiene

- A committee of the United Nations WHO/FAO Codex Alimentarius Commission - *Develop HACCP guidelines for international trade* - Work closely with NACMCF to define and refine HACCP principles and guidelines

decision tree

- A useful tool (optional in HACCP) - Not a substitute for expert knowledge

Food and Drug Act

- Administered by FDA: Food and Drug Administration (Not USDA) under Department of Health and Human Services - Responsible for *oversight of all other foods* including shelled eggs, wild game meats, fish, seafood, plus drugs, cosmetics, and medical devices

outcome of hazard analysis

- All production steps - Potential hazards associated with each production step - Justification of hazard - Hazard addressed in HACCP plan? (severity and likelihood of occurrence) - Control measure

Disposal method for product that cannot be reused

- Animal feed - Landfill - Incineration

Preliminary Tasks to Develop HACCP

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

locations of CCPs

- At steps where the *hazard can be prevented*, eliminated or reduced to acceptable levels - *Examples*: Thermal processing, chilling, product formulation control, testing for physical hazards

3 different categories of hazards

- Biological - Physical - Chemical

*components to hazard analysis:*

- Biological (major emphasis) - Chemical - Physical

initial validation:

- CCP verification (and calibration) *records* - Corrective action *records*: comply with any regulatory requirements - Previous audit *reports*: chronic problem areas (deli-style showcase)

Outcome of determining critical control points

- CCP's documented - Differ for the same product based on the facility

Implementation and Maintenance of the HACCP Plan

- Commitment from top management - List *HACCP coordinator* and *team responsible* for developing, implementing and maintaining the HACCP system - *Initiate product teams* to develop HACCP plans for specific products; Appropriate training - *Develop time line* of activities for HACCP plan development and implementation

how to control "growth of"

- Control over temperature, acidity, water activity, and atmosphere through: FSIS Inspection, FSIS Prerequisite Programs, FDA cGMPs and 8 Key Sanitation Conditions, HACCP System - spore germination: Some bacteria can sporulate: Spores survive cooking, germinate; allowing bacteria to produce toxins - both before human consumption or an enterotoxin after consumption - toxin production: Non-sporeforming bacteria multiply and inoculate the food with heat stable enterotoxins that cannot be destroyed through cooking - Temperature control is necessary to prevent spore germination and/or destroy toxin: Autoclave (retort) will kill spores and destroy toxin

NACMCF in november 1989:

- Created *seven principles of HACCP* - Endorsed the use of HACCP by industry and regulators - Provided a HACCP plan development guide for specific foods.

procedures to establish corrective actions

- Determine *what to do* when a deviation occurs - Determine *who is responsible* for implementing the corrective action - Determine the *disposition* of the non-compliant product (consult experts?) - Determine who will *develop and maintain* a record of the event

Prerequisites *vs HACCP*

- Deviation: unlikely to result in injurious products *vs serious consequences* - Generally managed in quality programs *vs food safety only* - Broad programs and multiple lines *vs Specific product and line* - Difficult to associate a failure with a particular lot *vs easy to point out a failure with a particular lot*

determining critical limits

- Each CCP will have *one or more control* measures with one or more *critical limits* - Based on temperature, time, physical dimensions, humidity, moisture (aw), pH, titratable acidity, available chlorine, preservatives or sensory attributes

noncontinuous effective monitoring procedures

- Establish a *reliable frequency* and procedure - Statistically based *data collection* or sampling plans

verification is based on:

- Expert advice / scientific studies - In-plant observations, measurements and evaluations

validating the HACCP plan - Validation tools

- Experts - *Scientific literature/studies* - In-plant observations/*measurements* - *Records*: CCPs, monitoring, corrective action

National Advisory Committee on Microbiological Criteria for Foods (NACMCF)

- First meeting in 1988 - *Scientific advisory committee* to the Secretaries of Agriculture, Commerce, Defense and Health & Human Services - *encourage adaption* of the HACCP approach to food safety

verification is reviewed periodically by an unbiased independent authority- internal, external experts, regulatory agencies:

- Flow diagram - Hazard analysis - Each HACCP step - Appropriate records

Industry concerns of HACCP

- HACCP as a *required regulation* to be widely utilized - Regulatory *access to company records*

revalidation - who

- HACCP team - independent individual - independent HACCP team

purpose of Conducting a Hazard Analysis

- Identify *hazards* and associated *control measures* - Identify any needed modifications to product or process to better *ensure product safety* - Provide *a basis* for determining *CCP's* in Principle 2

FSMA: imported food safety

- Importer accountability (*Importers must verify* foreign suppliers produce food with adequate preventative controls) - Third Party Certification (*Qualified third parties* can certify that foreign food facilities comply with U.S. food safety standards) - Certification for high risk foods (FDA has the authority to require that *high-risk imported foods* be accompanied by a *credible third-party* certification or other assurance of compliance as a condition of entry into the U.S.) - Voluntary qualified importer program (Voluntary program for importers providing *expedited review and entry* of foods from participating importers - eligibility limited to importers offering food *from certified facilities*) - Authority to deny entry (FDA can *refuse entry* into the U.S. of food from a foreign facility if *FDA is denied access* by the facility or the country in which the facility is located)

Food Safety Modernization Act

- January 2011: Final Rule by President Obama - Created to *ensure* the U.S. food supply is safe - Purpose is to proactively *prevent* contamination rather than federal regulators responding after the fact - *Similar* to HACCP program - *Includes* foods for human and animal consumption (animal feed and allergen)

FDA Applications of HACCP

- Juice products - Fish and Seafood - Retail and Food service products - Dairy products

FSMA: inspection and compliance

- Mandated inspection frequency (Based on *risk*; *High-risk domestic facilities* Must be inspected within five years of enactment - Records access (*Full access* to all records, including safety plans) - Testing by accredited laboratories (*Food testing* must occur at FDA accredited laboratories)

FSMA: response

- Mandatory recall (FDA holds authority to issue a mandatory recall when a company *fails to voluntarily recall unsafe food*) - Expanded administrative detention (FDA has a more flexible standard for administratively detaining products that *are potentially in violation of the law*) - Suspension of registration (FDA can suspend registration of a facility if the food poses *a reasonable probability of serious adverse health consequences* or death - If suspended, the facility can no longer produce its product) - Enhanced product tracing abilities (*Establish a system* that will enhance *tracking and traceability* for both domestic and imported foods; *Establish pilot projects* to effectively *identify recipients of food* to prevent or control a foodborne illness outbreak) - Additional Recordkeeping for High Risk Foods (Establish recordkeeping requirements *for facilities* that manufacture, process, pack, or hold foods that the Secretary designates as *high-risk foods*)

FSMA: preventative controls

- Mandatory written preventive controls for food facilities (Hazard analysis, Critical control points, Monitoring procedures, Corrective action, Record keeping) - Mandatory product safety standards (FDA must establish *science-based, minimum standards* for the safe production and harvesting of fruits and vegetables; both naturally occurring, and hazards introduced during processing) - Authority to prevent *intentional contamination* (FDA must issue regulations to protect against *intentional adulteration* of food)

How will the CCP be Monitored?

- Measurements: critical limits with *numerical values* (temperature, pH, Aw) - Observations (screen in place and intact; Ingredient is added, etc.)

examples of derived critical limits

- Milk pasteurization 161 degrees F/15 sec - Cooking ground beef patties 155F/15 sec - *Cured meat 155 degrees F/Uncured meat 160 degrees F*

HACCP Team

- Multi-Disciplinary - Represent all areas of plant (Engineering, Production, Sanitation, QA; HACCP Skills not Necessary to be on Team) - Outside Experts - Assure proper development - Assist - NOT write

record-keeping procedures: FDA requirements

- Name and location of processor / importer - Date and time of activity - Signature and initials of the operator - Product code, name and identity - Processing data entered when obtained - Reviewer's signature and date of review

types of independent checks

- Periodically measure an *internal cook temperature* with a properly calibrated thermometer - *A second person perform* or observe the same monitoring activity - *Microbial testing* to verify critical limits are met by suppliers

U.S. Army Natick Laboratories: "Modes of Failure Concept"

- Predict *what might go wrong* (a hazard), how, when, and where - *Select points* in the process (critical control points) - an increased probability of a food safety problem if the process is out of control.

revalidation - specific points as warranted

- Prerequisite programs - Raw materials - Equipment - Employee practices - Product formulation - Shelf-life - Packaging - Suppliers - Storage conditions - Preparation / processing practices - Product storage / distribution - Labeling - Emerging food safety hazards - Recalls / product withdrawals - Consumer complaints

Major elements of Food Safety Modernization Act

- Preventative Controls - Inspection and Compliance - Imported Food Safety - Response - Enhanced Partnerships

people responsible for effective monitoring procedures: production - *line supervisors*, selected *line workers*, maintenance, QC

- Proper training - Fully understand the purpose and importance - Capable of making adjustments to maintain control - Unbiased and accurate reporting - Immediate reporting of all deviations

verification of CCPs: *independent check*

- Provides *secondary assurance* that the hazard is being controlled as intended - Check the *method and frequency specified* in HACCP plan - *Records* become part of HACCP plan

Benefits of HACCP

- Reduces the amount of *foodborne illnesses and product* waste - Builds on *Quality Assurance* and Control programs - Incorporates *all levels* of plant personnel: from maintenance to management - Increases *operational efficiency*, profits, and *consumer confidence*

hazard identification

- Review *ingredients*, activities at each step of processing, equipment used, final product, method of storage and distribution, intended use and *consumers*. - *Brain storming* to *identify* biological, chemical and physical hazards that may be introduced, increased or controlled during processing - Epidemiological evidence, risk assessments

problems with noncontinuous effective monitoring procedures

- Seldom tests due to large numbers of samples - Technical limitations in detecting pathogens and toxins - False sense of security

verification procedures:

- Should require minimal end-product testing - Review HACCP plan for scientific and technical accuracy - Are the hazards control appropriate? - Are the CCP's and control strategies appropriate?

FSMA: enhanced partnerships

- State and local capacity building (Implement strategies to enhance food safety and defense capacities of State and local agencies - *offer multi-year grants* to facilitate investment in State capacity to *more efficiently achieve national food safety goals*) - Foreign capacity building (A plan to expand the capacity of foreign governments and their industries - for example, address *training of foreign governments and food producers* on U.S. food safety requirements) - Reliance on inspections by other agencies (FDA relies on inspections of other *Federal, State and local agencies* to meet its increased inspection mandate for domestic facilities; FDA can enter into *interagency agreements for inspection* of seafood facilities, both domestic and foreign, as well as seafood imports)

Re-validation of HACCP plan by HACCP team and independent experts

- System failures - Product formulation/ packaging changes - New hazards - Following HACCP plan - CCP monitoring - Corrective action records

HACCP records: the HACCP plan

- Team members and responsibilities - Description of food, distribution, intended use and consumer - Verified flow diagram

automatic alerts

- Time and temperature thresholds set by user. - Sent to appropriate employee when proper temperatures are reached for each process. - Sent when food temperature falls outside the user-defined acceptable range.

purposes of establishing monitoring procedures

- To *track trends* in the operation which *allows for corrective action* before a deviation occurs - To *determine deviations* at the CCP (exceeding or not meeting a critical limit) - To *provide written documentation* for verification

verification of HACCP plan: on-site audit

- Verifies that *implementation of the HACCP plan complies with* the written HACCP plan - *two major* activities: Review of HACCP records, On-site audit

Regulatory Requirements for Monitoring Meat/Poultry and Seafood

- Written *HACCP plan* must *describe monitoring procedures* and frequency of monitoring - Monitoring information, *date and time* must be *entered in monitoring records* during monitoring - *Person* conducting the monitoring must *sign* or initial each entry on the record sheet

3) supporting documentation

- critical control points: Diagram or flow chart *showing CCPs*, Deliberations in *determining CCPs*, Discussion of *CPs vs. CCPs* - critical limits: *Citations* from scientific literature, government regulations, *Precision and accuracy* of test method - monitoring procedures: *Copies* of all SOPs - normal fluctuation vs. loss of control, *Copies* of all test methods, *Precision and accuracy* of continuous monitoring methods at CCPs

SSOPs are *Tailor-made* for Establishments:

- livestock slaughter/processing - poultry slaughter/processing - import inspection - warehouses

review of HACCP records

- records: *Current HACCP* plan: basis for verification, *Audit reports* of prerequisite programs - *End result*: determines if *the facility has been operating* according to the HACCP plan

Meat Inspection Act

- requires that there be federal inspection at production plants - Administered by *FSIS*: Food Safety Inspection Services of USDA - Domestic market *meats*, later expanded to include *poultry* and *egg* products (not shelled eggs)

HACCP (Hazard Analysis Critical Control Point)

- the most effective system to ensure *food safety* - A methodical and systematic application of *science and technology* to plan, control and document the *safe production* of foods

Top concerns:

-"Presence of": Bacteria, viruses, prions, and parasites -"Growth of": Bacteria -Spore Germination: Followed by toxin production by bacteria -Toxin Production: By non-sporeforming bacteria

corrective action records

-*Accurate record* of all violated product -*Quantity and codes* of all product held, released, destroyed or reworked

Storage of Raw Materials and Ingredients:

-*Bulk containers* designed and constructed to prevent contamination -Held at room temperature/relative humidity -*Frozen materials* kept frozen and thawed before use so as to prevent adulteration -*Re-work material* properly identified

Food-contact surfaces

-*Corrosion-resistant* when in contact with food -Manufactured from *non-toxic materials* -Designed to *withstand the environment* of their intended use in regard to food, *cleaners* and *sanitizers*

*THREE ELEMENTS* OF CORRECTIVE ACTION (NACMCF)

-*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

reasons for keeping records

-*Documents* procedures and processes in HACCP plan -Adherence to critical limits -Monitoring activities -Regulatory compliance *audits*: compliance with the HACCP plan -Assist in identifying products involved *in recalls*

verification of CCPs: calibration

-*Ensure accuracy* of measurements (Pressure, temperature, time, pH, flow rate, R.H.) -*in the HACCP plan*: Piece of equipment, Calibration frequency, Person responsible -If equipment is *not within tolerance*: *Recalibrated* or replaced, *Review records* back to last acceptable calibration for possible critical limit violations and impact on product safety (impact of calibration frequency)

Production and Process Controls cGMPs

-*Inspection and storage* of raw materials and other ingredients -Inspected for cleanliness -*Segregated* and stored to prevent contamination/deterioration -*Raw materials* washed or cleaned as necessary to remove soil -*Water for washing*, rinsing and conveying must be potable -Inspect raw material containers

Verification (Checking) -

-*Ongoing activities* to demonstrate conformance to the HACCP system -Those activities that determine that *the system is operating according to the plan*

1) summary of the hazard analysis

-*Potential hazards* identified along with the significance and likelihood of occurrence -*Justification* or discussion of *control measures* to prevent, eliminate or reduce the hazard to an acceptable level -*Table format* (hazard analysis form)

corrective action taken will *vary* based on:

-*Processing parameters* -*Type of food* manufactured

Warehousing and Distribution cGMPs

-*Protect final product* from microbial, chemical and physical contamination during storage and distribution -*Protect against deterioration* of the food and container

Monitoring Procedures: Measurements/Observation

-*Real-time* assessment vs. analytical testing -Designed to *detect deviations and alert personnel* to appropriate corrective action -Adequate *training of personnel* for objectivity and accuracy - Best observer

Monitoring Procedures: Measurements

-*Select an appropriate monitoring "device"* (pH paper vs. pH meter) -*Accuracy* (How close a measured value is to the actual true value? -*Precision* (How close the measured values are to each other?) -*Recalibrate the device to ensure accuracy* (verification).

Freezer with cold storage compartments fitted with:

-*Thermometer* or temperature measuring/recording device -*Automatic control* or *alarm system* for maintaining proper temperature

Types of adjustments:

-*Time and temperature* - *pH* - *Reroute ingredients* (moisture/nitrite) not meeting criteria to fully cooked products

Step 5. Resources

-*Updating/adapting* equipment -Monitoring systems -Data storage systems

USDA REGULATORY REQUIREMENTS

-*Written description* of corrective action required in HACCP plan -*Action* taken must ensure that: The *cause of the deviation* is identified and eliminated and The *CCP* is brought *back under control* by the corrective action -Deviation is *prevented from recurring* -*No unsafe product* enters commerce: Segregate and hold, Test for safety -*Determine if* deviation/unforeseen hazard needs to be included *in the HACCP plan* -*Requirements of 9CFR 417.3 must be met*

BSE - Bovine spongiform encephalopathy

-A prion: a modified form of a normal protein -Progressive and fatal neurological disease of cattle, may be related to CJD disease in humans -Source: Infected brain and spinal cord tissue. -Extremely resistant to heat and normal sterilization processes.

in Determining Biological Hazards, consider Characteristics of an organism:

-Ability to grow in food -Ability to survive on food -Infectious dose of organism -Or amount of toxin formed

SSOP's for Meat and Poultry Must include the following:

-All *daily procedures* used before and during operations to prevent direct contamination or adulteration of product -*SSOP's signed and dated* by person with overall authority -Mandatory *minimum pre-operational procedures* that include cleaning of food contact surfaces, equipment and utensils -*Frequency* at which each SSOP is to be conducted and *who is responsible* for completion

Listeria monocytogenes: three alternatives

-Alternative I: includes post lethality treatment AND an antimicrobial agent or process to suppress the growth of LM for duration of product's shelf-life -Alternative II: includes post lethality treatment OR an antimicrobial agent or process to suppress the growth of LM for duration of product's shelf-life -Alternative III: Use of sanitation measures ONLY for control of LM

Purpose of Prerequisite Programs

-Assure the *proper function* of HACCP in producing safe foods -*Simplifies* the development and maintenance of HACCP plan -An essential component of operations

adjusting the process:

-Automatic *in-line monitoring* and control (flow-diversion valves): Pasteurization, In-line fillers, Cookers -*Non-automatic* monitoring and control: *Operator takes action* specified by management

Establishing critical limits:

-Based on aforementioned information -*In-plant research* (ex: Cooling rate to minimize B. cereus growth during processing; Recommended rate vs. other acceptable rates)

"N-60" Sampling Method

-Beef trim combo-bins of 2,000lbs. each are tested individually or in groups of 5 -Forceps and scalpel are used to remove 60 small pieces weighing 6- 7g. each from the carcass surface or from trim combo-bin -Collectively weighs around 375 grams - Tests for E. coli O157:H7 -Product is held until sample test results are completed -If first test is negative: product is safe to ship -If first test is presumptive positive: need a confirmation sample (If second sampling is negative: product is safe to ship, If second sampling is positive again: product is marked for "cooking only" or rendering)

Sources of microbial hazards

-Beef: Salmonella, E. coli O157:H7, C. perfringens -Poultry: Salmonella, Campylobacter; C. perfringens -Vegetables: L. monocytogenes, C. botulinum, Salmonella -Fruits: Salmonella, E. coli O157:H7, -Fish: Vibrio, C. botulinum, parasites, viruses -Eggs: Salmonella -Juice: E. coli O157:H7, Salmonella, Cryptosporidium -Spices: Salmonella, Clostridium -Personnel: Viruses, Staphylococcus -Receiving: Types of raw materials handled -Wet Environment: Listeria Dry -Environment: Salmonella

Shiga Toxin-Producing Escherichia coli (STEC) intervention strategies before and during grinding

-COA from supplier (need to conduct verification). -Treatment of trim. (Hot water, Organic acids (lactic acid, peroxyacetic acid), Combination treatments) -Microbiological testing of lots.

verification records

-Calibration *records to confirm accuracy* of monitoring equipment -Periodic *measurements or observations* for record -HACCP *audit report* from verification

monitoring records: continuous monitoring

-Circular charts (time / temperature) -Electronic (metal detector) -Supplemented by charts, logs, check lists and laboratory data sheets

Step 3. Employee Training

-Continuous education -Must understand importance of assigned duties -*Periodic verification* of employee performance

Validation (Science) -

-Demonstrates that the *HACCP system (as designed)* can adequately control hazards to product a safe, unadulterated products -The collecting and evaluating of *scientific and technical information* to determine if the HACCP plan will effectively control the hazards

chemical hazard control measures: processing

-Direct Food Additives (Prerequisite Programs) -Indirect Food Additives (Prerequisite Programs)

Monitoring Devices

-Direct contact with product can potentially introduce hazards (pH probe: bacteria, Thermometer: mercury, glass, bacteria) -Discard product in direct contact with contaminated device to eliminate any hazard -Frequent cleaning/sanitizing of the device

monitoring records: discontinuous monitoring

-Every sampled lot or test documented -Use standardized forms or log book

Salmonella Performance Standards

-FSIS selected Salmonella as the target organism for which to establish standards in processing facilities -Used as a measure of process effectiveness in controlling contamination by this pathogen in slaughter and raw ground product operations -Establishments and FSIS use a means to check the effectiveness of the HACCP systems

Programs that may be considered as prerequisites:

-Facilities -Production equipment -Raw product control -Sanitation -Chemical control -Production and quality controls -Glass control -Receiving, storage, and distribution -Traceability and recall -Complaint investigations -Labeling -Training

in food chemical hazards: direct processing additives

-Flavor enhancers, color additives, thickeners -Curing ingredients, allergens, stabilizers (Pink Cure (Sodium Nitrite concentration in final product)) -Microbiological processing/packaging aids

chemical hazards - "contains" (included in foods):

-Found in Raw Materials -Direct processing additives (allergens)

Controls - Prevent Growth of Foodborne Disease Agents

-Freezing -Refrigeration -Proper cooling -Hot holding -Decreasing pH -Preservatives -Multiple factors (hurdle technology)

Parasites: examples

-Giardia -Cryptosporidium parvum -Cyclospora

Staphylococcus aureus control

-Good personal hygiene practices: Washing hands, Covering wounds -Proper temperature control of foods: Keep hot foods hot and cold foods cold

HACCP records include...

-HACCP plan -Support documentation (Validation records) -Other records generated by the HACCP plan

Botulism Outbreak in NY, causes & outcomes

-Had *not had an inspector* in the Bon Vivant Plant in 4 years. -Bon Vivant soups *undercooked* and not much in the way of record keeping. -Filed for bankruptcy in a month

Controls - Prevent Contamination of Food:

-Harvesting practice (Shellfish harvest areas) -Growing practices (Fruits and vegetables grown in areas separated from farm animals) -Prevent cross contamination (Separation of raw and cooked foods, Cleaning and sanitizing of shared surfaces)

Critical Limits: HACCP Steps

-Hazard analysis -Identify CCP's -Identify *control measures* -Identify *how/where* control measures *must be applied*

What to assess when validating the HACCP plan

-Hazard analysis (Are all significant hazards identified and properly controlled?) -*CCP's* -*Critical limits* -Monitoring -Corrective action

HACCP Plan summary table (7 steps)

-Hazards of concern - must be prevented, eliminated or reduced to acceptable levels -CCP's - control identified hazards -Critical limits - should be respected to ensure that each CCP is under control -Monitoring - assure that CCP are under control -Corrective Action - when monitoring indicates that a critical control point is not under control -Verification and procedures & schedule - confirm proper functioning of the HACCP system -Record-keeping procedures - organize documents regarding all procedures and records related to these principles and to their application

campylobacter control

-Heat treatment -Intervention strategies to reduce prevalence in raw poultry

control of salmonella species

-Heat treatment (Concern with low Aw products at minimally process temperatures) -Prevention of cross contamination (Air flow/dust control, Residue on equipment) -Reduction on incoming raw materials

Controls - Destroy or Remove Foodborne Disease Agents:

-Heat treatment (time/temperature) -Irradiation -Freezing for parasites -Surface washes (ex. carcass wash) -New technologies (ex. high pressure, pulsed light, etc.)

chemical hazards - "is added" (non-foods):

-Indirect processing additives -Building or equipment maintenance chemicals (Grease, Mineral oil) -Cleaning, sanitizing, or pest control chemicals (Laundry detergent, Highly concentrated sanitizer) -Storage and shipment chemicals

non-food chemical hazards

-Indirect processing additives (Boiler water additives, Peeling aids, Defoaming agents) -Building or equipment maintenance chemicals (Grease, Mineral oil, Paints/Coatings) -Cleaning, sanitizing, or pest control chemicals (Laundry detergent, Highly concentrated sanitizer, Pesticides) -Storage and shipment chemicals (Cross-contamination with various types of chemicals)

Current Good Manufacturing Practices (cGMP's)

-Listed in Code of Federal Regulations (21 CFR 117 Subpart B) -Establish the *conditions and practice* that food industry must follow for safe food production under sanitary conditions

Viruses - Hepatitis A

-Low infective dose ( 10 to 100 virus particles) -Fever, malaise, nausea, abdominal discomfort, jaundice S -pread through personal contact to food or food contact surface -Associated with ready-to-eat foods

Viruses - Norovirus

-Low infective dose ( 10 to 100 virus particles) -Vomiting, diarrhea, and dehydration -Spread through personal contact to food or food contact surface -Associated with ready-to-eat foods, shellfish, and contaminated water

Equipment and Utensils cGMPs

-Manufactured and designed for adequate cleaning -Installed and maintained to *facilitate adequate cleaning* of equipment and surrounding area

Campylobacter

-Mode: Infection -Causes diarrhea (sometimes bloody), cramping, fever, can result in Guillain-Barre syndrome -Infective dose: less than 1,000 organisms -Symptoms last several days to a week -Most common cause of sporadic bacterial enteritis -Cases of illness associated with undercooked poultry and meat, unpasteurized milk, and contaminated water -Microaerophilic (low oxygen) gram negative curved rods; motile -Will not grow below 30ºC; sensitive to drying -No unusual heat resistance -Primary reservoir: Many animals including poultry, cows, pigs, sheep, and wild birds. Also contaminated water and flies. -30% decline observed by FoodNet for Campylobacter (attributed to HACCP, GMPs, and consumer education) -Campylobacter remains a primary agent for sporadic diarrheal foodborne illness in the United States -Campylobacter is reported to be present on 90% of poultry carcasses

Listeria monocytogenes

-Mode: Infection -Causes diarrhea, meningitis, encephalitis, septicemia, miscarriages, stillbirths -Affects high risk groups - Pregnant women, neonates, and immunocompromised adults -Symptoms develop within 3 to 70 days -Transmitted to foods via post process handling, or food is inadequately processed. -Recent issues - Sliced deli meat and other RTE meats, hot dogs, cheese, ice cream, coleslaw and cantaloupes -Gram positive, non-spore forming, facultative, motile rod -Associated with animals, soil, water, food plants (cold and moist areas) -Growth and survival (Low Temperature - growth as low as 0ºC, and can survive freezing; pH - growth down to 5.6*, and may survive below 4.3 ;Aw - growth down to 0.93, can survive to 0.83; High temperature - inactivated at temperatures above 50ºC* (D-values at 160ºF - up to 5 seconds))

Salmonella species

-Mode: Infection -Causes severe diarrhea with fever, vomiting, and dehydration -Infective dose: as few as 20 cells to 10,000 -Onset usually 12 to 14 hours -Symptoms last 2 to 3 days (can get reactive arthritis 2 to 3 months later) -Cases of illness associated with undercooked meat and poultry, eggs, cereal, pet food, peanut butter, produce (tomatoes, peppers) -Facultative anaerobe, gram negative rods -Optimal growth 37ºC and pH 6.5 to 7.8, but can grow as low as 2 to 4ºC and up to 54ºC, and pH from 4.5 to 9.5* -Primary reservoir: Intestinal tract of animals -Incoming animals and animal products including eggs, contaminated produce, nuts, and grains, insects, birds -Can survive in dry foods and refrigerated foods for prolonged periods of time

Clostridium botulinum

-Mode: Intoxication -Causes paralysis, blurred vision, death -Symptoms start to develop within hours -Organism grows to large numbers in food where it produces toxin. The toxin is ingested and affects neurological system. -Associated foods: improperly processed canned foods, honey, garlic-in-oil mixtures, temperature abused foods (cooked potatoes, stews, etc) -Gram positive, spore forming, anaerobic rod -Proteolytic strains: spores can survive temperatures over 110ºC, but do not grow below 12.5ºC -Non-proteolytic strains: spores can survive temperatures up to 82ºC, but can grow down to 3.3ºC -pH: growth minimum pH 4.7 -Found in soil and water

Staphylococcus aureus

-Mode: Intoxication -Causes vomiting, nausea, and abdominal cramps -Symptoms develop within 4 hours of ingestion and last 24 to 48 hours -Transmitted to foods via post process handling: organism grows on a temperature abused food item and produces a heat-stable toxin. The ingested toxin causes the illness. -Recent issues: batter, cooked chicken, canned mushrooms, cream filled pastries -Gram positive cocci that grow under aerobic and anaerobic conditions -While organism can grow as low as 6.7ºC, optimal growth and toxin production occurs between 40 and 45ºC -Toxin is heat stable Salt tolerant (up to 20%) and can grow at Aw as low as 0.84 -Primary reservoir - Animals including humans (skin, hair, nose, open sores, boils, saliva)

Clostridium perfringens

-Mode: Toxin mediated infection -Causes diarrhea, severe dehydration, cramps -Symptoms develop within 8 to 22 hours -Organism grows to large numbers in food (108), organisms are ingested, and then produce toxin in intestine -Associated foods: temperature abused foods, roast beef, stews, meat gravy, poultry -Gram positive, spore forming, anaerobic rod -Heat resistance: spores can survive boiling -Found in soil, intestinal tracts of animals

Shiga Toxin-Producing Escherichia coli (STEC)

-Mode: Toxin mediated infection -Causes severe bloody diarrhea, cramping, fever, and can lead to HUS Infective dose - as few as 10 cells -Onset usually 4 to 10 days -Symptoms last 4 to 14days (6% lead to HUS with half of that requiring dialysis, fatality ~1%) -Cases of illness associated with undercooked beef, spinach, sprouts, cookie dough -Shiga toxin-producing Escherichia coli, a type of enterohemorrhagic E. coli (EHEC) bacteria -Includes serotype E. coli O157:H7, and 6 other non-O157 strains O26, O45, O103, O111, O121, and O145. -Facultative anaerobe, gram negative rods -Acid tolerant - growth down to pH 4.0 to 4.5 -No unusual heat resistance (D value of 9.6s at 64.3ºC) -Primary reservoir - Intestinal tract of cattle, as well as sheep and goats. -Seasonal pattern of outbreaks during warmer months.

*Dried and intermediate moisture foods* maintained at a safe moisture level by:

-Monitoring aw -Controlling soluble solids-water ratio in final product -Barriers against moisture pickup

Mold

-Multicellular fungi - form mycelium -Grow over a wide pH range (below 1 to 11) -Grow at low Aw (as low as 0.6) -Some species produce mycotoxins

FDA REGULATORY REQUIREMENTS

-Must either follow a *corrective action plan* or *segregate and hold the product* for evaluation - *Written* corrective action plans *NOT required* in HACCP plan -Corrective action plan: Ensures that *no unsafe product* enters commerce and Ensures that the *cause of the deviation* is corrected - Assess *potential modification* of HACCP plan - *Corrective action records* must fully *document* the actions taken

in Determining Biological Hazards, consider Characteristics of the Food:

-Need to determine whether certain microorganisms can grow in a food (or survive even if conditions don't favor growth). -Antimicrobials inherent in the food may inhibit growth and/or survival. -Hurdle Effect: the combination of factors (such as temperature and moisture) may work together to inhibit growth

with documentation (written prerequisite plan), Include standard operating procedures (SOP's):

-Objectives -Procedures -Practices -Job description/requirements

areas that Current Good Manufacturing Practices (cGMP's) are needed in:

-Personnel -Ground, building and Facilities -Equipment and Utensils -Production and Process Controls -Manufacturing Operations -Warehousing and Distribution

chemical hazard control measures: raw materials

-Plant/Animal Foods (Good Agricultural Practices, Purchase Specifications, National Residue Program, Total Diet Study) -Packaging Materials (Purchase Specifications)

HOW TO PREVENT PHYSICAL HAZARDS

-Prerequisite programs -Good Manufacturing Practices -Paperwork -Observation (Visual inspection) -Detection equipment (Metal detector, X-ray equipment, UV-Light equipment) -Sorting equipment (Screen or sifter) -Removal procedures and/or equipment (Bone separator)

BSE - Bovine spongiform encephalopathy control

-Prevent importation of high risk animals and products. -Prohibit feeding of mammalian protein to ruminants. -Surveillance and quarantine suspected infected animals -Control of Specified Risk Material (SRM) -Control of cattle greater than 30 months of age -Control of non-ambulatory cattle.

Meeting Alternatives for Listeria Control

-Processing: Post packaging heat treatment -Formulation changes: Product characteristics (fermented, nitrites, high salt, low water activity), Chemical agents (organic acids, allyl isothiocyanate, etc), Biological agents (live cultures, bacteriocins) -Packaging: Incorporation of antimicrobials -Sanitizers in the post-process environment -Plant sanitation to prevent harborage sites and points for cross contamination with specific attention to biofilms -Prevent entry through people, materials, and equipment -Monitoring of environment -Proper temperature control of foods -Temperature and moisture control in environment

The Jungle

-Published in *1906* -Written to expose the appalling working conditions in the *Chicago Meat Packing Industry* -*Mr. Sinclair's* descriptions of diseased, rotten, contaminated meat and gross insanitary conditions shocked the public

Production and Process Controls cover

-Raw Materials and Ingredients Containing *Natural Toxins* (i.e. Aflatoxin) -Raw Materials and Ingredients Containing Natural or *Unavoidable Defects* (i.e. Pests, Extraneous Material)

Hold perishable foods to *prevent adulteration*:

-Refrigerated foods: < 41°F -Frozen foods: keep frozen -Hot foods: > 140°F -Heat treating acid/ acidified foods to destroy mesophilic organisms when the product is to be stored anaerobically at ambient temperatures

lawsuits due to physical hazards

-Restaurant sued after woman bites into olive pit: settled for $100,000 -Supermarket sued for serving a rock in a salad: plaintiff awarded $65,000

record review:

-Reviewed by a *designated* HACCP-trained *individual* -Frequency of review (*USDA/FSIS*: reviewed prior to shipping product, *FDA*: seafood HACCP records reviewed within 1 week) -Review of records is the *final control measure* for assuring product safety

organisms of concern in pork

-Salmonella -C. perfringens -T. spiralis -Y. enterocolitica

organisms of concern in fruits

-Salmonella -E. coli O157:H7 -Cyclospora -L. monocytogenes -Norovirus

organisms of concern in vegetables

-Salmonella -E. coli O157:H7 -L. monocytogenes -C. botulinum -Norovirus

organisms of concern in poultry

-Salmonella -Campylobacter -C. perfringens -T. gondii

organisms of concern in milk/dairy

-Salmonella -Campylobacter -L. monocytogenes -Y. enterocolitica

organisms of concern in beef

-Salmonella (Raw) -E. coli O157:H7 (Raw) -C. perfringens (Cooling) -L. monocytogenes (RTE products)

personnel - education and training

-Sanitation/personal hygiene -Food handling techniques -Food protection principles

Top CCPs addressed by McDonalds & CSU

-Skinning -Eviscerating -Final Washing -Chilling and Fabricating -Storing and Distribution

HACCP plan includes...

-Team members and responsibilities -Description of food, distribution, intended use and consumer -Verified flow diagram

2) the HACCP plan

-The written document that *outlines the formal procedures* to be followed in accordance with the *7 principles* of HACCP -Supporting documents: Appropriate HACCP *test methods*, *SOPs / GMPs*, Sample HACCP *records*

in food chemical hazards: found in raw materials

-Toxins, heavy metals, allergens (Common in marine fish) -Antibiotics, hormones, pesticides (Common in market animals, reason for weaning period before harvest) -Packaging materials

retention of records:

-USDA/FDA requirements similar: *1 year*: slaughter activities and refrigerated foods, *2 years*: frozen, preserved and shelf-stable foods

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 and record-keeping

organisms of concern in fish & seafood

-Vibrio spp. -C. botulinum -Viruses -Helminths -Norovirus

Monitoring Activities at CCP's

-Visual observations -Measurements of parameters (Time, Temperature, pH, Etc.)

Step 2. Documentation for compliance

-What procedures are performed? -How often? -By whom? -Action if procedures are not performed as written? -Action if procedures do not produce the expected outcome?

Personnel cGMPs

-disease control -cleanliness -education and training -supervision

how to kill/injure biological hazards

-heat (Hot water, steam vacuuming, steam pasteurization) -pH (Low pH (Acidic): Use of an organic acid application like Acetic acid, lactic acid, mixtures; High pH (Basic): Use of a basic application like Trisodium phosphate) -oxidation (Chlorox, Purex, chlorine based products) -others (irradiation, ultraviolet light, high pressure)

Step 1. Commitment from management

-time -resources

moisture: yeast

.88-.8

moisture: bacteria

.95-.88

NASA's two concerns about space food:

1) *Crumbs and water droplets* in zero gravity with electrical equipment (Bite-sized foods and edible coatings to hold foods, Special packaging to minimize exposure of foods) 2) *Microbiological safety*: foods are free from pathogens, parasites and biological toxins

four types of HACCP records

1) Summary of the hazard analysis 2) The HACCP plan 3) Supporting documentation 4) Daily operational records

_________ deaths due to foodborne illness

1,351

Beef Jerky Thermal Processing reduction of lethality is likely due to 2 reasons:

1. *Evaporative cooling* on the surface of the beef strip keeps it from getting hot enough 2. *Early stages in heating* may make the pathogens *more heat-resistant* so that they survive the *later stages* of the process

3 principles of the original HACCP system

1. *Identify and assess hazards* potential hazards throughout growing, harvesting, and processing 2. *Determine critical control points* (CCPs) to control any identified hazard 3. *Establish systems to monitor* all identified CCPs

*seven principles of HACCP*

1. Conduct a Hazard Analysis 2. Determine the Critical Control Points (CCPs) 3. Establish Critical Limits 4. Establish Monitoring procedures 5. Establish Corrective Actions 6. Establish Verification procedures 7. Establish Record-Keeping and Documentation procedures

four essential elements listed:

1. Plant's use of Sanitation Standard Operating Procedures (*SSOPs*) 2. *Adopt HACCP* as a system of process controls to limit food safety hazards 3. *Meet Pathogen Reduction Performance* Standards set by FSIS-USDA 4. Conduct *tests for Generic E. coli* to verify the plant's control system prevents fecal contamination

Four Steps in Establishing Monitoring Procedures

1. What attribute will be monitored at the CCP to control the identified hazard 2. How will the attribute be monitored (Procedures) 3. When will it be monitored? (frequency) 4. Who will perform the monitoring procedures?

two stages of hazard analysis

1. hazard identification 2. hazard evaluation

FSIS specially required that establishments develop HACCP plans that fall into the *nine processing categories*:

1. slaughter - all species 2. Raw product - ground 3. Raw product - not ground 4. Thermally processed - commercially sterile 5. Not heat treated - shelf stable 6. Heat treated - shelf stable 7. Fully cooked - not shelf stable 8. Heat treated but not fully cooked - not shelf stable 9. Product with secondary inhibitors - not shelf stable

operating limit example: In hot dog production, an operating limit of 170*F was established for the internal product temperature - This is...

10 degree above control limit of 160*F Throughout the day, an occasional 168*F is measured, however product does not need to be placed on hold because it is well above the critical limit

The *critical limit* for cooking chicken is 165F. It was found that the product had better sensory scores when heated to 172F. Therefore the *operating limit* was set at...

172F

Botulism Outbreak

1971 - A deadly outbreak of botulism linked to Bon Vivant's cold potato soup (Westchester, New York). *New York man had died* and his wife has become seriously ill from botulism

The original HACCP system

1971 National Conference on *Food Protection* in Denver: *HACCP was first presented* to an audience beyond NASA

Jack in the Box outbreak

1993: *Hamburgers contaminated with E. coli* O157:H7 infected over 700 people, killing 4 children and leaving over 100 with permanent kidney and brain damage

Performance standards for whole chickens have been in place since...

1996

Incidents/illnesses caused by physical hazards:

2%

how long does it take for bacteria populations to double

20 minutes

claims due to physical hazards

2007: McDonald's processed over 4,500 claims because of physical hazards -90% ended up being fraudulent -800 cases settled out of court

______ known agents of foodborne disease

31

Incidents/illnesses caused by chemical hazards:

4%

Temp danger zone

40-140

danger zone

40-140 degrees Fahrenheit-- optimal temperature for microbial growth

__________ hospitalizations due to foodborne illness

55,961

_____ million illnesses

9.4

Incidents/illnesses caused by biological hazards:

94%

moisture: mold

<.8

Critical Limits Codex definition

A criterion that *separates acceptability from unacceptability*

Critical Limits FDA definition

A maximum and/or minimum value (not an average) to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce the occurrence of the food safety hazard to an acceptable level

HACCP Principle 4: Establish Monitoring Procedures

A planned *sequence of observations* or measurements that are recorded to determine if a *CCP is under control*

HACCP Principle 2: Determine Critical Control Points (CCP's)

A step at which *control is essential* to either prevent / eliminate the hazard to reduce the hazard to an acceptable level

Critical Control Points (CCP)

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

Decision Trees (NACMCF and Codex) are...

A useful tool in determining CCP's

Some Cleaners Used in the Industry:

A. Chlorine containing compounds (Na or Ca-hypochlorite, Gaseous Cl) B. Aldehydes (Formaldehyde, Phenols, Alcohols, Acids) C. Quaternary ammonium compounds (QUATS; Not corrosive but low efficient on spores) D. Oxygen-releasing substances (Peroxide compounds, Per-acetic acid)

physical hazards

Added foreign material introduced into the food product

Personnel - Disease control -

Any person who by medical exam or supervisory observation is *deemed ill or infected* shall be excluded from handling food

Control Point (CP)

Any step at which a biological, physical, or chemical factors can be controlled

prevent-reduce-eliminate

Attempts to assure food safety depends on the effort to *prevent, reduce, or eliminate* all biological hazards to an acceptable level

Other Common Bacterial Pathogens

Bacillus cereus Vibrio spp. Yersinia enterocolitica Shigella ssp. Aeromonas hydrophila

Jack in the Box outbreak cause

Believed to be caused by *meat being contaminated by fecal material* on the harvest floor

reduce

Biological hazards to an acceptable level (By killing; minimizing growth, outgrowth, and toxin production)

National Residue Program (FSIS - USDA)

Collects and analyzes domestic and imported meat, poultry, and egg products for chemical residues of veterinary drugs, pesticides, and environmental contaminants (ex: KIS test)

When will the CCP be monitored?

Conducted *sufficiently often* to: -Detect when a deviation has occurred -Prevent such foods from reaching consumers

effective monitoring procedures are...

Continuous and rapid (preferred) - *chemical and physical* methods [biological methods often too slow: exceptions - ATP assay]

Clostridium perfringens control

Cool foods rapidly after heating

Critical Limits FSIS definition

Critical Limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirements set forth, are met

records

Dated and signed by the person doing the monitoring

Meat (HACCP definition)

Defined in 9 CFR 301.2 as the part of the muscle of any cattle, sheep, swine, or goats which is skeletal

Poultry (HACCP definition)

Defined in 9 CFR 381.1 as any domesticated bird (chickens, turkeys, ducks, geese, guineas, ratites, or squabs, also termed young pigeons from one to about thirty days of age), whether live or dead.

Egg Product (HACCP definition)

Defined in 9 CFR 590.5 as any dried, frozen, or liquid eggs, with or without added ingredients...

purpose of validation

Determine if the HACCP system is actually controlling the identified hazards

purpose of verification

Determine if the HACCP system is functioning according to the plan

HACCP Principle 1: Conduct a Hazard Analysis

Develop a list of *biological, chemical and physical hazards* that are: Reasonably likely to occur, Reasonably likely to cause injury or illness if not effectively controlled

National Residue Program consists of...

Domestic (scheduled & inspector generated) and Import Re-inspection Sampling Plans

prevent

Effort to prevent any biological hazard contamination or growth throughout processing: farm to fork

likelihood of occurrence examples

Epidemiological data, literature, impact of food preparation method, transportation, storage, *target population*

Manufacturing operations cGMPs

Equipment, utensils and food containers properly maintained by cleaning / sanitizing

chemical adulteration/hazards

FDA Definition: A food is "chemically adulterated" if: (a) the raw material contains a poisonous, deleterious, or injurious substance (b) if such substance is added during production, processing, or preparation of the food product

FATTOM (the six favorable conditions required for the growth of foodborne pathogens)

Food, Acidity, Temperature, Time, Oxygen, Moisture

most common physical hazards

Glass, Wood, Stones, Metal, Jewelry, Bone, Plastic, Insulation, Bullets/BB shot, Needles

control of viruses

Good Personal Hygiene Proper Handwashing Wearing gloves Policy for employees to report health issues

Listeria monocytogenes: RTE products which are post-lethality exposed must control Listeria monocytogenes through...

HACCP or other prerequisite programs

how many CCPs are needed?

HACCP plan can be modified; Number and location of CCP's *frequently changed* during HACCP plan development and implementation

HACCP Principle 7: Establish Record - Keeping and Documentation Procedures

HACCP records: Hazard analysis summary - rationale for hazards and control measures

*Too many CCPs* will over burden the...

HACCP with non- safety issues

Purpose of determining critical control points

Hazards *reasonably likely to cause* injury or illness in absence of control must be addressed

Escherichia coli O157:H7 Intervention strategies on farm and pre-slaughter:

Housing, feed, and water Antibiotics Vaccine Probiotics/ competitive exclusion Chemical Transportation Holding pens Cattle cleanliness

reviewers of record-keeping and documentation

In-house, outside consultants, customers, regulators

NACMCF also altered...

Inspector's roles in the plant too

*Inline pH measurement* improves consistent grade of end products:

Measuring pH inline has tremendous benefits such as a more reliable *live measurement*, ability to *control the process instantly*, and the *labor savings* alone can yield an immediate return on investment.

in 1906, Congress passed...

Meat Inspection Act and Food & Drug Act

biological hazards:

Microorganisms such as bacteria, viruses, yeasts, molds and parasites; Some of the hazards are pathogenic and/or produce toxins

Who will monitor the CCP?

Monitoring personnel • *Operations staff (line supervisor or selected line worker)*: Best qualified to detect deviations and take corrective actions

Microbial Contamination of Raw Materials and Ingredients

Must be either (a) *free of microorganisms* that can cause foodborne diseases in humans of or (b) *treated* to reduce any risk to an acceptable level

______________________ equipment in food manufacturing area must be kept clean

Non-food contact

top eight pathogens (Caused 89% of Single-Etiology outbreaks):

Norovirus 39% Salmonella 26% STEC 6% Scrombrotoxin 5% Clostridium perfringens 5% Staphylococcus enterotoxin 3% Ciguatoxin 3% Campylobacter jejuni 2%

Critical Limits NACMCF definition

One or more prescribed tolerances that must be met to ensure that the CCP effectively controls the biological, chemical or physical hazard (NACMCF)

eliminate

Only possible through a "Kill Step"; Biological hazards present in foods are removed

Production and Process Controls

Overview: Required for all operations in *receiving*, transporting, segregating, preparing, manufacturing, packaging and *storing* of food

Based on _______________ rather than inspection

PREVENTION

FDA's 8 Common Allergens (US)

Peanuts, Tree nuts, Eggs, Milk/Dairy, Soy, Wheat, Fish, Shellfish

Government-established food safety criteria

Performance standards (regulatory standards or guidelines) • *Milk pasteurization*: (161°F/15 sec) • *Low-acid canned food*: 12-D reduction (Bot Cook) • Scientifically validated • Data is verifiable ("Science-based")

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)

foodborne infection

Person consumes a food that contains a *bacteria, virus, prion, or parasite* then multiplies in the body and causes illness

indirect measurement example

Practical dwell time and cooking of temperature

Ice Contacting Food

Prepared from *potable water* according to cGMP's

purpose of establishing corrective actions

Prevent potentially hazardous foods from reaching consumers

*seven principles of HACCP (more elaborate)*

Principle 1 - Identify any hazards that must be *prevented, eliminated or reduced* to acceptable levels Principle 2 - Identify the critical control points (CCP) to *control identified hazards* Principle 3 - Establish critical limits that should be respected to ensure that *each CCP is under control* Principle 4 - Establish a monitoring system to assure that *CCP are under control* Principle 5 - Establish corrective actions when monitoring indicates that a *critical control point is not under control* Principle 6 - Establish verification procedures that *confirm proper functioning* of the HACCP system Principle 7 - Organize documents regarding *all procedures and records* related to these principles and to their application

prions

Prions are thought to be the cause of a group of diseases called transmissible spongiform encephalopathies/BSE

Corrective action: Definition (NACMCF)

Procedures followed when a *deviation occurs*

HACCP Principle 5: Establish Corrective Actions

Procedures followed when deviation occur

Prerequisite Programs to HACCP - Foundational Programs

Procedures, including *Good Manufacturing Practices*, that provide *environmental and operational conditions* (foundation for the HACCP system).

Common Bacterial Pathogens in Food (emphasis on food processing)

Salmonella Shiga Toxin producing E. coli (O157:H7 and other STECs) Listeria monocytogenes Campylobacter Staphylococcus Clostridium perfringens Clostridium botulinum

How will the CCP be monitored?

Sampling and Testing Procedures (*Rarely appropriate* for microbial hazards)

verification examples

Sampling, Calibration Direct observation of monitoring Records review

____________ on food-contact surfaces must be smooth bonded

Seams

*Protection against metal* and other extraneous material in food with...

Sieves, magnets, metal detectors

Listeria monocytogenes: Post-lethality exposed product is RTE product that has the potential to be contaminated in that it comes into direct contact with a food contact surface and/or is exposed to environment after the lethality treatment and prior to packaging; ex:

Slicing, peeling, re-packaging, cooling in brine

hazard:

Something that would contaminate and/or adulterate the final product causing the food product to be unsafe for human consumption

HACCP DEVIATION RECORDS

Standard production form: - Hold number - Deviation - Reason for hold - Number of containers held - Date of hold - Date and code of product held

Five Steps to Establishing Prerequisite Programs

Step 1. Commitment from management Step 2. Documentation for compliance Step 3. Employee Training Step 4. Verification Step 5. Resources

Definition of HACCP

Systematic approach to the identification, evaluation and control of *food safety hazards*

Corrective Actions

Taken when *SSOP fails* to prevent product contamination or adulteration

HACCP System or Program:

The *result* of implementing the HACCP Plan

HACCP Plan:

The *written document* that delineates the procedures to be followed

KIS test

The Charm KIS™ test for kidney is an antibiotic detection test for kidney. tissue. Its principle of detection is microbial inhibition

Low-Temperature Cooking of Summer Sausage and Pepperoni summary

The increased acid in *fermented products increases the effective kill*

HACCP Principle 3: Establishing Critical Limits

The maximum and/or minimum value to which a biological, chemical or physical hazard must be controlled at a CCP to prevent, eliminate or reduce the hazard to an acceptable level of occurrence

log phase of bacterial growth curve

The period of exponential growth of bacterial population; bacteria starts to grow exponentially because its in right temp or found food

4) daily operational records

Three basic types of records: -Monitoring Records( Continuous and Discontinuous) -Corrective Action -Verification

specified risk materials (SRMs)

Tissues in cattle that are considered to be of high *risk* for prion contamination

purpose of establishing critical limits

To distinguish between *safe operating* conditions and *unsafe deviations* at a CCP

Verification (checking) - purpose

To ensure that the *HACCP* plan is being implemented properly - *ongoing activities*

Development, implementation and maintenance of *written SSOP's* mandated by...

USDA

In 1862, Abraham Lincoln founded...

United States Department of Agriculture (USDA)

validation vs verification vs calibration

Validation - science Verification - checking Calibration - accuracy

HACCP Principle 6: Establish Verification Procedures - *validation*:

Validation: "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*"

chemical hazard control measures: storage/shipping

Various cross-contaminants (Prerequisite Programs)

chemical hazard control measures: building/equipment maintenance

Various kinds of Prerequisite Programs

chemical hazard control measures: cleaning/sanitizing/pest control

Various kinds of Prerequisite Programs

HACCP Principle 6: Establish Verification Procedures - *verification*:

Verification: Those activities other than monitoring that *determine the validity of and compliance with the HACCP plan*. These include verification of prerequisite programs, verification of the critical control points, and verification of the overall HACCP plan.

*potable water*

Water that meets the standards for drinking purpose (40 CFR 141)

Beef Jerky Thermal Processing

Whole muscle jerky is intended to be a dry product with desirable texture and shelf-stability. Yet, the drying of the *product may reduce the lethality* of the process and not adequately kill pathogens on the surface.

personnel - cleanliness

Workers who are in direct contact with food, food-contact surfaces and food- packaging materials will maintain *proper hygienic practices*

A single HACCP plan can be established for ...

a *single product* that passes through multiple processing categories

inspectors went from being a command & control regulator to...

a Performance Standard Monitor

Production and Process Controls *must comply with current FDA regulations*, guidelines and...

action levels for poisonous and deleterious substances

*Proper disposal or reprocessing* of...

adulterated foods / ingredients

SSOPs have an Emphasis on *preventing*...

adulteration, contamination and cross-contamination

Sanitation and Standard Operating Procedures

also known as SSOPs; documented steps which must be followed in the food industry to ensure proper cleaning of product contact and non-contact surfaces

Critical Limits are a *specific value*, not..

an average

Approximately 120 chemical compounds across roughly 20 compound classes are quantified by the National Residue Program, examples:

antibiotics, sulfonamides, growth promoters, medication, heavy metals, etc.

death phase of bacterial growth

as resources become insufficient, bacteria die off; they die from the toxins they produce during stationary phase and the lack of food left for them to consume

Operating Limits that are in excess of control limits will help to...

avoid routine violations of critical limits

Provide evidence that the HACCP plan is...

being followed

Problem with numbering CCPs: numbering can cause *confusion* if HACCP plan requires...

changing

top 5 food-germ pairs causing outbreaks in 2015

ciguatoxin, scombroid toxin/histamine, salmonella in chicken, salmonella in pork, campylobacter

HACCP as a combined system:

combined system of *science and technology* to produce safe food products

personnel - supervision

competent supervisory personnel responsible for *enforcing personnel* cGMP's

biological hazards are the largest...

concern for the food industry

Parasites: sources

contaminated water or foods that have come in contact with contaminated water, employees with organism

Equipment, containers, and utensils used to convey food properly constructed, maintained and handled to prevent...

contamination

Two Types of Monitoring

continuous and discontinuous

*Too few CCPs* will not permit adequate...

control of the hazards

Records are the *proof* that a CCP was *controlled* or that...

corrective actions were taken

Monitoring Critical Control Points is *a key element* in...

determining if critical limits are being met

*Potentially different hazards* for the same product based on facilities or processes, such as...

different person, location, equipment

*Manufacturing steps* (e.g., washing, peeling, extruding, cutting, drying, whipping) accomplished so as *to prevent contamination* by...

dripping or draining

*Decrease CCP's*:

eliminate non-safety issues and hazards that are NOT reasonably likely to occur

Biological CCP's are not needed for *acid and low-acid canned foods* which are regulated under...

existing canning regulations

Clostridium botulinum symptoms

food poisoning; weakness, trouble seeing, feeling tired, trouble speaking, weakness of the arms, chest muscles, and legs

benefits of record-keeping and documentation

food safety, equipment performance (*prevent deviations*)

*Compressed air or other gases* introduced into foods or used to clean...

food-contact surfaces or equipment treated to prevent contamination

One of the *most common CCP's* is the use of a *heat treatment* for products in the:

heat-treated, shelf-stable; heat-treated, not shelf-stable; and not fully cooked, not shelf-stable categories.

*heat penetration*

heating/cooling rate

Identify where and how (hazard analysis) a food safety problem may occur in...

ingredients, product, processing, storage, and shipment

*Never erase* data - use...

ink

lag phase of bacterial growth curve

intense activity preparing for population growth, but no increase in population WE TRY TO KEEP BACTERIA HERE!

Growth stages of bacteria

lag phase, log phase, stationary phase, death phase

Failure to comply with SSOP's can lead to...

legal or criminal action

Control addition of acid and amount of acidified ingredients added to...

low-acid food

biological hazards are the hardest to...

maintain control over

*Operational sanitation* procedures are *written procedures* for...

maintaining sanitation during product preparation, storage and handling

SSOPs are An *essential prerequisite* program for HACCP because they Helps assure production of wholesome, unadulterated food, Enhances product quality, shelf-life and operational efficiency, and reduces...

maintenance costs

HACCP as a management system:

management system (*prevention of hazards*) to ensure the production of safe food products

Meat and Poultry Products (9 CFR 308 and 381) Mandates *continuous inspection* of all...

meat and poultry slaughter operations by USDA

direct measurement example

meat thermometer for internal temperature

acidity

microbial growth can happen 4.6-7.5 pH

Beef patties: monitor internal cook temperature vs....

monitoring the cooking process (time in oven/patty thickness)

the idea of HACCP is to cover all types of food safety hazards (biological, physical, and/or chemical) - whether they are...

naturally occurring in the food or present in the surrounding environment

stationary phase of bacterial growth

new cells are produced at the same rate as the old cells die, leaving the number of live cells constant the bacteria have reached their maximum population that can be supported; also they produce some toxins in high numbers

*Determination* of CCP based on the *hazards and control measures* identified during hazards analysis; Each hazard must be controlled at...

one or more CCP's

operating limits are set by the processing plant based upon...

operating data

Unnumbered CCPs: use names such as...

oven, pasteurizer, packaging, etc.

operating limits

parameters more stringent than those necessary for safety and are established for reasons other than food safety

14 common allergens (Europe)

peanuts, tree nuts, eggs, milk/dairy, soybeans, fish, crustaceans (lobster, crab, shrimp), mollusks (oyster, snail, dam, squid), mustard, celery, lupin, sulfites, sesame, cereals containing gluten

*Continually monitor* the process vs...

periodic checks of product temperature

*Adequate data* is needed to support the...

prediction under adequate control and process steps Process validation

HACCP is a common sense approach based on...

prevention rather than inspection

Allergenic substance control in food establishments is important in...

product formulations and to prevent cross- contamination.

CCP Number depends on:

product, ingredients, processing methods and prerequisite programs

Records must include...

production lot, product code, product name, and identity

Clostridium botulinum control

proper processing, proper cold

Operating Limits that exceed Control Limits may be important for...

quality reasons

Monitor pH of...

raw materials, food in process and final product

Protect finished product from contamination by...

raw materials, other ingredients and refuse

• HACCP monitoring must provide...

real-time data

Must *complete hazard analysis* first to endure that the hazards being assessed are...

reasonably *likely to cause illness* or injury

operating limits exceed...

regulatory requirements and recommendations

establishing critical limits is Scientifically based and derived from...

regulatory standards / guidelines, literature, experimental results or experts

top 5 food-germ pairs causing outbreak-associated illnesses in 2015

salmonella in seeded vegetables, salmonella in pork, salmonella in vegetable row crops, norovirus, clostridium perfringens

Alternative level affects...

sampling requirements and USDA involvement

Holding, conveying and manufacturing systems designed and constructed for...

sanitary maintenance

Example of critical limits: An established time/temperature cook of 165F for 15 seconds to eliminate enteropathogens. If the plant wants to establish a critical limit of 158F for 2 minutes, then...

scientific studies will be needed

*Pre-operational sanitation* Ensures that facilities, *equipment and utensils are free from...*

soil, tissue debris, chemicals and other hazards before starting

In 1959 *Pillsbury* worked with US Army to create...

space foods for NASA (the manned space program)

*Increase CCP's*:

specific hazards overlooked

Facility Construction and Design:

suitable in size, construction and design to facilitate maintenance and *sanitary operation*

HACCP is Based on *common-sense* application of _____________ and ____________ principles to the production process from "farm-to-fork"

technical and scientific

Critical limits established by...

tests and experiments (heat penetration, temperature distribution, thermal death, Inoculated pack/microbial challenge studies)

FDA and USDA Require the *development of CCP's* for each hazard identified in...

the hazard analysis

Critical limits must *satisfy the capabilities* of...

the manufacturer

Purpose of HACCP is to potentially limit all contact of any hazard throughout...

the production process

USDA is responsible for...

the safety of meat, poultry, and egg products (*Inspection services, Survey of commodities, Research*)

Thermal death

time for specific pathogens (D-values)

examples of effective monitoring procedures

time, temperature, pH, sanitizer concentration, biosensors

severity examples

type of illness, duration, exposure (short and long term), complications

Parasites: control

use of potable water, good personal hygiene

Post-lethality and antimicrobial treatments must be...

validated

A corrective action consists of:

• *Acting immediately* to prevent adulterated product from entering commerce • *Identifying and eliminating* the cause of the deviation • *Bringing the CCP* under control • Establishing measures to *prevent recurrence* of the deviation

*Regulatory consideration* for critical limits:

• *Addressed by* both FDA and USDA • Critical limits *must be listed* for each CCP • USDA critical limits designed *to meet USDA-established targets*, performance standards and other requirements • *Less stringent critical limits* must be supported with sound scientific data

Person responsible for monitoring:

• *Designated* in the HACCP plan by job title • *Signs or initials* the monitoring records • *Not by name* since the person will not always be present - illness, vacation, etc.

Basic Steps

• *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

Corrective action For deviations for SSOP's:

• *Develop procedures* for employees and management to fix it. • *Document* corrective action.

Implementation and Monitoring - Develop procedures for assessing SSOP effectiveness:

• *Organoleptic / sensory*: sight, feel smell • Chemical: sanitizer level • *Microbial*: swabbing, culturing for pathogens or indicator organisms

Operational Sanitation:

• *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 gloves, hair restraints, hand washing and health • Develop plans for handling product in *raw and cooked areas*

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

DISPOSITION OF PRODUCT "*UNDER HOLD*"

• *Review data* to identify safety concerns • *Appropriate tests* to verify safety of "held" product • Divert product *to another product* where safety can be assured • *Re-work or re-process* the product (metal detector malfunction) • *Donation*

Maintenance of SSOP's

• *Routinely evaluated* for effectiveness • *Revised* as necessary to reflect changes in facilities, equipment, operations and personnel

Discontinuous Monitoring problems

• *Sensitivity* of test procedure • *Statistical confidence* needed

Continuous Monitoring used when:

• *Variation, spikes or drift* in critical limit may go unnoticed • *Critical limit is very* close to operating limit

Some highlights of prerequisite programs:

• *Water testing* records must be maintained • *The building* should be away from areas of potential contaminants such as feedlots, waste disposal areas. • *Written specifications* of all ingredients should be in place. *Suppliers* should be approved with GMPs and HACCP, etc. Obtain letters of guarantee. • *Proper plant design:* e.g., material receipt and storage area should be separate from process area, doors and windows adequately screened to prevent pests. • *Air* intake should be *filtered.* • *Monitoring* of microbiological contamination in areas of cooking, refrigeration, etc. • *Metal control* may be managed as a CCP (at the end of processing line) • *Proper labeling* of all ingredients and chemicals. • *Complaint Investigations* - Feedback from consumers should be considered carefully. Problems should be corrected. • *Product retrieval* - complete distribution records with lot coding should be maintained.

control points are Numerous for most products

• *supply-chain* • storage temperature • *processing factors* • sanitation practices • deliver system

critical limits of Clostridium botulinum

• 12 log reduction ("12D") - Commercially sterilized • 3 min at 121.1* C

*Salvaging* the product *depends on the process and product*:

• Batch process: *raise temperature* of the cooker • Continuous process: place "*on-hold*" or immediately *re-process* the product (product quality concerns)

General Sanitation Includes the following:

• Cleaning of equipment • Cleaning the facility • Personnel practices • Equipment design and operation • Pest control • Warehousing practices

examples of continuous monitoring

• Cycling of oven temperature • In-line measurement of pH

Record-keeping Requirements:

• Daily SSOP records for implementation, monitoring and *corrective action* • *Initialed and dated* by supervisor • Records kept on-site for at least 48 hours and retained off site for at least 6 months

Pre-Operational Sanitation:

• Develop detailed written procedures for *daily cleaning* of product contact surfaces, equipment and facilities • Describe equipment *disassembly and re-assembly* after cleaning/sanitizing • *Sanitizer approved* for the intended use and prepared according to manufacturer • Use acceptable cleaning techniques

Failure to meet critical limits can mean:

• Evidence of direct *health hazard* • Development of health hazard (canning) • Product not produced under conditions assuring safety and subject to *recall*

All HACCP monitoring records should contain the *following information*:

• 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 • Date of review

controlling microbial hazards: Bacterial Destruction

• 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

What will be monitored?

• Measure *carcass temperature* after chilling • Measure *product temperature* after cooking • Measure *product pH* after fermentation, • Conveyor *belt speed*, product thickness, etc.

Development of SSOP's for Meat and Poultry:

• Pre-Operational Sanitation • Operational Sanitation

Implementation and Monitoring - 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

continuous monitoring

• Preferred • Data logger or recording chart • e.g., HTST pasteurization at 161F/15 sec or UHT pasteurization at 275F/2 sec

corrective actions include the following:

• Procedure for *re-work* or disposal • Means to *re-establish* sanitary conditions • *Prevent* reoccurrence

record-keeping procedures: general concerns

• Record data in a *timely and accurate fashion* (not pre-recorded or late) • Errors in record are *"lined out"* (not erased), initialed, dated and explained • Use a *standard form* • Reviewed regularly for *completeness* and accuracy

Examples of Parameters that May Be Critical Limits

• Temperature • pH • Moisture level • Line speed • Product visual defects • Time • Flow Rate • Water Activity • Salt concentration • Physical dimensions • Weight • Viscosity • Sanitizer concentration • Operation of a metal detector

in Determining Biological Hazards, evaluate:

• Types of contaminates associated with the food or the process • Characteristics of food • Type of microorganism • What types of controls are in place

Discontinuous Monitoring used when

• continuous monitoring is *impractical* • variability is *low* • operating parameter is *far away* from the critical limit

Discontinuous Monitoring examples

•*Minimum internal cook temperature* of a product (Worse case basis - largest pieces from coldest area of an oven, Random sampling - statistically determined frequency) • Cooking oil temperature: 350°F with a lower critical limit of 300°F

Designating CCP's

•Numbered sequentially (CCP1, CCP2...) •Numbering based on type of hazard (biological, chemical, physical); (CCP B1, CCP B2, CCP C1, CCP C2)

Agency Verification

•Review SSOP's •Review daily records •*Direct observation of implementation*, specific procedures and corrective action •*Direct observation/testing* to assess sanitation


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