Managing Food Safety: A Manual for the voluntary use of HACCP principles for Operators of food

service and retail establishments

Purpose and Scope

 Foodborne illness in the United States is a major cause of personal distress, preventable death,
and avoidable economic burden. Mead et al. (1999)

 Around 76 million illnesses, 325,000 hospitalizations and 5000 deaths in the US each year.

THAT’S WHY

 United States Food and Drug Administration (FDA) made this manual, in partnership with
federal, state, and local regulators, industry, academia, and consumers, to assist you, the
operators of retail and food service establishments, in efforts to produce safe food. Also to
prevent or reduce foodborne illness.

Who has the responsibility for ensuring safe food?

Producers Shippers Processors

Distributors Handlers

 By voluntarily developing a food safety management system, you can better ensure that the
foods served or sold in your establishment are safe.

What is my health inspector’s role in helping me to prevent foodborne illness in my establishment?

 Regulatory food inspection programs provide you with feedback on how well you are controlling
certain conditions in your establishment that can lead to foodborne illness.

 How was this manual prepared?

 The procedures and information presented in this manual were prepared with feedback
received from regional FDA food safety seminars and Food Safety Initiative grassroots meetings.
In addition, the Conference for Food Protection (CFP) has reviewed and endorsed this manual
and has provided FDA with comments and suggestions on two separate occasion.

Is it a requirement that I implement a food safety management system based on HACCP principles?

 The Food Code clearly establishes that the implementation of HACCP at retail should be a
voluntary effort by industry. If, however, you plan on conducting certain specialized processes
that carry considerably high risk, you should consult your regulatory authority to see if you are
required to have a HACCP plan.
BACKGROUND

Retail and food service industries

Unlike many food processing operations, the retail and food service industries are not easily defined by
specific commodities or conditions. These establishments share the following characteristics:

 These industries have a wide range of employee resources, from highly trained executive chefs
to entry-level front line employees.

 Many are start-up businesses operating without the benefit of a large corporate support
structure.

 There is an almost endless number of production techniques, products, menu items, and
ingredients used. Suppliers, ingredients, menu items, and specifications may change frequently.

List of the types of businesses that are part of the retail and food service industries:

 Back-country guided trips for groups  produce

 Bakeries  meat and seafood
 Bed and breakfast operations  Health care facilities
 Cafeterias  Interstate conveyances
 Camps - recreational, children’s, etc.  Markets
 Casinos, bares, and taverns  Meal services for home-bound persons
 Child and adult day care  Mobile food carts
 Church kitchens  Penal institutions
 Commissaries  Restaurants
 Community fund raisers Convenience  chains
stores full service  international specialties
 Fairs  fast food
 Food banks  full service
 Grocery stores with specialized  independent operations
departments schools  road-side stands
 deli  schools
 in-store prepared foods

Food Safety Hazards

Hazards include –
 Biological agents • Bone and metal fragments
• Bacteria and their toxins • Packaging materials
• Parasites  Chemical Contamination
• Viruses • Natural plant and animal toxins
 Physical Objects • Unlabeled allergens (allergen-causing protein)
• Bandages • Nonfood-grade lubricants
• Jewelry • Cleaning compounds
• Stones • Food additives
• Glass • Insecticides
Foodborne illness risk factors

The Centers for Disease Control and Prevention (CDC) Surveillance Report for 1993-1997,
“Surveillance for Foodborne-Disease Outbreaks – United States,” identifies the most significant
contributing factors to foodborne illness.

• Food from Unsafe Sources

• Inadequate Cooking

• Improper Holding Temperatures

• Contaminated Equipment

• Poor Personal Hygiene

Active managerial control?

Active managerial control means the purposeful incorporation of specific actions or procedures
by industry management into the operation of your business to attain control over foodborne illness risk
factors. It embodies a preventive rather than reactive approach to food safety.

Regardless of the system you use, effective elements of a food safety management system may include:

• Certified food protection managers who have shown a proficiency of required information by
passing a test that is part of an accredited program
• Standard operating procedures (SOPs)
• Recipe cards
• Purchase specifications
• Equipment and facility design and maintenance
• Monitoring procedures
• Record keeping
• Employee health policy for restricting or excluding ill employees
• Manager and employee training
• On-going quality control and assurance
• Specific goal-oriented plans, like Risk Control Plans (RCPs), that outline procedures for
controlling specific foodborne illness risk factors

THE USE OF HACCP AS A FOOD SAFETY MANAGEMENT SYSTEM

 Since the 1960’s, food safety professionals have recognized the importance of HACCP principles
for controlling risk factors that directly contribute to foodborne illness. The principles of HACCP
embody the concept of active managerial control by encouraging participation in a system that
ensures foodborne illness risk factors are controlled.

THE USE OF HACCP AS A FOOD SAFETY MANAGEMENT SYSTEM

 HACCP is not a stand-alone program, but is built upon a foundation of operational practices
called prerequisite programs. The success of a HACCP program is dependent upon both facilities
and people. Furthermore, FDA recommends that managers and employees be properly
 motivated and trained if a HACCP program is to successfully reduce the occurrence of foodborne
illness risk factors.

Seven HACCP principles

 Principle 1: Conduct a Hazard Analysis

The hazard analysis is the foundation of the food safety system. Federally inspected
establishments must conduct hazard analyses for each process. During the development and design of
the hazard analysis, establishments must consider all three types of hazards – biological, chemical, and
physical – at each step they identify in the production process.

 Principle 2: Determine Critical Control Points

A hazard is controlled by one or more critical control points (CCPs). A critical control point is
defined as a point, step, or procedure in a food process at which control can be applied, and, as a result,
a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.

Points may be identified as CCP when hazards can be prevented, for example:

• introduction of chemical residue can be prevented by control at the receiving stage;

• a chemical hazard can be prevented by control at the formulation or ingredient-addition stage;

• pathogenic bacteria growth can be controlled by refrigerated storage or chilling.

CCP may be identified where hazards can be eliminated, for example:

• pathogenic bacteria can be killed during cooking;

• metal fragments can be detected by a metal detector and eliminated by removing the
contaminated product from the processing line;

• parasites can be killed by freezing.

Points may be identified as CCPs when hazards are reduced to acceptable levels, for example:

• the occurrence of foreign objects can be minimised by manual sorting and automatic
collectors;

• some biological and chemical hazards can be minimised by obtaining shellfish from approved
waters

 Principle 3: Establish Critical Limits

Critical limits (CL) are the parameters that indicate whether the control measure at the CCP is in
or out of control. CL is a maximum or minimum value to which a biological, chemical, or physical
parameter must be controlled at a CCP to prevent, eliminate, or reduce to an acceptable level the
occurrence of a food safety hazard.
Types of Critical Limit

 Chemical limits

These may be associated with the occurrence of chemical hazards in the product and its
ingredients or with the control of microbiological hazards through the product formulation and intrinsic
factors.

Examples:
 maximum acceptable levels for mycotoxins
 pH
 Salt
 labeling or absence of allergens.

 Physical limits

These are often associated with the tolerance for physical or foreign material hazards. It
involved in the control of microbiological hazards, where the survival or death of the microorganism is
governed by physical parameters.

Examples:
 absence of metal
 intact sieve (sieve size and retention)
 Temperature
 Time

 Procedural limits

These are more difficult but usually will be associated with procedural control measures.

Example: “debagging (sanitary) operating procedure followed at all times”

May be a critical limit where the control measure to prevent packaging materials entering the
product stream is a specific debag procedure.

 Microbiological limits

Microbiological limits should normally be avoided as part of the HACCP system. This is because
microbiological factors can usually only be monitored by growing the organism of concern in the
laboratory, a process that may take several days.

 Principle 4: Establish Monitoring Procedures

Monitoring is a planned sequence of observations or measurements to assess whether a CCP is

under control and to produce an accurate record for future use in verification. Monitoring procedures
usually involve either a measurement or an observation.
 Monitoring has three objectives:

 To track control of the process.

 To determine when there is a loss of control and a deviation occurs.
 To provide a written document to be used in verification.

 Principle 5: Establish Corrective Actions

When there is a deviation from the critical limit, corrective actions are required to prevent
potentially hazardous foods from reaching consumers. The corrective actions consist of:

 Identifying and eliminating the cause of the deviation,

 Ensuring that the CCP is under control after the corrective action is taken,
 Ensuring that measures are established to prevent recurrence, and
 Ensuring that no product affected by the deviation is shipped.

 Principle 6: Establish Recordkeeping and Documentation Procedures

Records are written evidence documenting the operation of the HACCP system. All
measurements taken at a CCP, and any corrective actions taken, should be documented and kept on file.
These records can be used to trace the production history of a finished product.

 Principle 7: Establish Verification Procedures

Verification ensures that the HACCP plan is being implemented as written. Verification confirms
the accurate monitoring of the critical control points. The verification procedures demonstrate that the
HACCP system is adequately controlling food safety hazards.

Common Prerequisites Program for Food Safety: PRPs and Operational PRPs

Common prerequisite Program:

 Facilities
 Supplier Quality Assurance
 Specification
 Product Equipment
 Cleaning and Sanitation
 Personal Hygiene
 Chemical Control
 Receiving, Storage and Shipping
 Traceability and Recall
 Pest Control
Facilities

• Water supply shall be potable at point of use.

• Drainage and waste disposal shall be considered.

• Cleaning shall be effective to avoid cross-contamination.

• Temperature control of storage facilities or production environment as needed.

• Air quality and ventilation—to minimize airborne contaminants and humidity.

• Lighting—to be able to see properly for hygiene and designed to avoid physical cross-
contamination.

• Storage—to avoid pest access, cleanable, separated from non-food items such as cleaning
chemicals and lubricants.

Plant “GMP” area map

Example hygiene juncture for entry/exit of high control zones

Supplier Quality Assurance

One of the key areas for initial focus alongside HACCP development is raw material safety. It is
particularly important to know that the supplier is controlling hazards if these cannot be controlled in
our process or by consumer action.

 SQA program includes:

 Specifications

 Auditing suppliers

 Certificates of Analysis

o Specifications

A typical raw material specification would include the following:

• Details of supplier and manufacturing/supply location, i.e., not simply the head

office or broker that the order is placed with. This detail may not be included if

you are buying against your own specification on the open commodity market.
 • A description of the raw material and its functionality.

• An ingredients list (to enable allergen assessment).

• Details of all intrinsic factors with tolerance limits, e.g., aw, pH, salt,

preservatives.

• Microbiological, chemical, or physical acceptance criteria, e.g., absence of

identified hazard organisms in a specified sample size.

• Analytical and microbiological sampling plans.

• Labeling requirements.

• Storage and distribution conditions.

• Safe handling and use instructions.

• Description of pack type, size, and quantity.

o Supplier auditing

SQA audit is critical to the safety and quality of your products and ultimately your brand reputation,
so it is vital that it is carried out by competent personnel who can evaluate food safety controls and
build a trusting relationship with the suppliers.

o Certificates of analysis

Certificates of analysis can be obtained for individual lots of raw materials to verify that these have
been sampled and tested for specified criteria.

Equipment

A basic principle of hygienically designed equipment means that:

– Surfaces should be smooth, accessible, and self-draining if wet cleaned.

– Made of materials compatible with what it’s going to be in contact with—both the
product and the cleaning chemicals.
– Easy to access for cleaning, inspection, and maintenance.
– Fit for purpose, i.e., being used for what it was designed to do.
– It shall be adequately maintained
– Waste and control of chemicals—clearly identified and controlled to prevent cross-
contamination.
Cleaning and Disinfection (Sanitation)

Sanitation program is one which is based on a risk assessment, is documented, and is validated
as being effective and routinely verified.

The key elements that you should have in your program are as follows:

1. Sanitation risk evaluation

2. Determination of cleaning methods
3. Sanitation schedules/cleaning procedures

Personal Hygiene

Health status (of employees)

 This is important to understand whether individuals might be carriers of disease that

can be transmitted through food.

Illness and injuries

 Reporting of infectious diseases.

 Exclusion from food handling duties.

Personal cleanliness

 Including hand washing, appropriately controlled protective clothing, and footwear.

Personal behavior

 Spitting, coughing, or sneezing over food is considered inappropriate behavior.

 Personal effects such as jewelry, cell phones, etc. should be prohibited in food handling
areas.

Visitors

 Should be adequately supervised and required to follow the same standards as

employees.

Chemical Control

 All chemicals used must be suitable for food use and approved by the appropriate
authorities.

 A Material Safety Data Sheet (MSDS), sometimes called a hazard data sheet, must be
retained on file along with a supplier continuing guarantee.

 Chemicals must be stored securely and in accordance with the manufacturer’s

recommendations.
Receiving, Storage and Shipping

 Commodities or product that need to be transported in certain environments

should be appropriately controlled.

 Dedicated for food use where appropriate.

 Use of temperature control devices.

 Containers and conveyors are maintained in good condition and be easy to clean.

Traceability and Recall

Lot identification

 To enable efficient and effective product recall.

 For stock rotation purposes.

Product information and labeling

 For allergens, preparation, or cooking instructions and storage requirements.

 Straightforward language to ensure that the next person in the food chain
understands.

Consumer education

 Must be able to understand, for example, about the importance of avoiding

cross-contamination and the importance of time/temperature control in
controlling foodborne illness

Pest Control

 Pest Control Chemicals

 Pest control chemicals like all chemicals at the plant must be stored securely
and clearly labeled. A MSDS should be kept on file confirming suitability for food
premises.

 Bird Control

 Regular removal of food sources and elimination of roosting and nesting sites,
doors must be fitted with air or strip curtains and kept closed, and use of
predator bird calls is often effective.

 Rodent Control

 Bait stations must be tamper resistant, secured to the location, and locked.

 Mechanical traps can be used in areas around entryways and regularly

inspected and maintained.

 Use poison bait in areas external to the plant

  Insect Control

 Electric insect killers (EIKs) should be located outside of the exposed food
production areas

 Any pesticides used on site should be recorded by name, % active ingredient,

target organism, method and rate of application, area treated, license number
and name of applicator, date, and signature.

Developing a HACCP plan

 Task 1 -Establish a HACCP team

To fully understand the commodity system and be able to identify all likely hazards and CCPs, it
is important that the HACCP team is made up of people from a wide range of disciplines. The team
should include:

 A team leader to convene the group and to direct the work of the team ensuring that
the concept is properly applied. This person must be familiar with the technique, be a
good listener and allow all participants to contribute.

 A specialist with a detailed knowledge of the commodity system is required. This

specialist will have a major role in the production of the commodity flow diagrams.

 Several specialists, each with an understanding of particular hazards and associated

risks, e.g. a microbiologist, a chemist, a mycotoxicologist, a toxicologist, a QC manager, a
process engineer.

 People, such as packaging specialists, raw material buyers, distribution staff or

production staff, farmers, brokers, who are involved with the process, and have working
knowledge of it, may be brought into the team temporarily in order to provide relevant
expertise.

 The team's progress and results of the analysis should be recorded by a technical
secretary.

If any changes are made to composition or operational procedures, it will be necessary to re-
assess the HACCP plan in the light of the changes.

The first activity of the HACCP team is to identify the scope of the study. For example, will the
whole commodity system be covered, or only selected components? This will make the task more
manageable and specialists can be added to the team as and when they are required.

 Task 2 - Describe the product

To start a hazard analysis, a full description of the product, including customer specification, should be
prepared using a form such as that given in Appendix III. This should include information relevant to
safety, e.g. mycotoxin regulation/target level, composition, physical/chemical properties of the raw
materials and the final product, the amount of water available for microbial growth (aw), the amount of
acid or alkali in the product (pH). Also information regarding how the product is to be packaged, stored
and transported should also be considered together with facts regarding its' shelf life and recommended
storage temperatures. Where appropriate, labelling information and an example of the label should be
included. This information will help the HACCP team to identify 'real' hazards associated with the
process.

 Task 3 - Identify the product's intended use

How the product is intended to be used is an important consideration. Information on whether

the product will be consumed directly, or be cooked, or be further processed, will all have a bearing on
the hazard analysis, see task 6). The nature of the target group for the product may also be relevant,
particularly if it includes susceptible groups such as infants, the elderly, and the malnourished. The
likelihood of misuse of a product should also be considered, such as the use of pet food as a human
food, either by accident or design. This information can be recorded on the same form as the product
description.

 Task 4 - Draw up the commodity flow diagram

The first function of the team is to draw up a detailed commodity flow diagram (CFD) of the
commodity system, or that part of it which is relevant. The expertise of the commodity specialist is
important at this stage. Commodity systems will differ in detail in different parts of the world, and even
within one country there may be a number of variants. Secondary processing will need to be detailed for
each factory, using generic flows only as a guide.

 Task 5 - On site confirmation of flow diagram

Upon completion of the CFD, members of the team should visit the commodity system (e.g.
farm, store or manufacturing area) to compare the information present on the CFD with what actually
happens in practice. This is known as "walking the line", a step by step practice to check that all
information regarding materials, practices, controls etc. have been taken into consideration by the team
during the preparation of the CFD. Information such as time of harvest, drying procedures, storage
conditions, the marketing chain, socio-economic factors, grading systems and any incentive for
improved quality or safety, and processing systems, should be collected and included in the CFD as
appropriate. The site for which the HACCP plan is being designed should be visited as many times as
possible to ensure that all relevant information has been collected.

 Task 6 - Identify and analyses hazard(s) - (Principle 1)

Effective hazard identification and hazard analysis are the keys to a successful HACCP Plan. All real or
potential hazards that may occur in each ingredient and at each stage of the commodity system should
be considered. Food safety hazards for HACCP programs have been classified into three types of
hazards.

 Biological: typically foodborne bacterial pathogens such as Salmonella, Listeria and E.

coli, also viruses, algae, parasites and fungi.

 Chemical: There are three principle types of chemical toxins found in foods: naturally
occurring chemicals, e.g. cyanides in some root crops, and allergenic compounds in
peanuts; toxins produced by micro-organisms, e.g. mycotoxin, and algal toxins; and
 chemicals added to the commodity by man to control an identified problem, e.g.
fungicides or insecticides.

 Physical: contaminants such as broken glass, metal fragments, insects or stones.

The probability that a hazard will occur is called a risk. The risk may take a value from zero to one
depending on the degree of certainty that the hazard will be absent or that it will be present. After
hazard identification, a hazard analysis must be conducted to understand the relative health risk to man
or animal posed by the hazard. It is a way of organizing and analyzing the available scientific information
on the nature and size of the health risk associated with the hazard. The risk may have to be assessed
subjectively and simply classified as low, medium, or high.

 Task 7 - Determine the critical control points (CCPs) - (Principle 2).

Each step in the commodity flow diagram, within the scope of the HACCP study, should be taken
in turn and the relevance of each identified hazard should be considered. It is also important to
remember the stated scope of the HACCP analysis at this stage. The team must determine whether the
hazard can occur at this step, and if so whether control measures exist. If the hazard can be controlled
adequately, and is not best controlled at another step, and is essential for food safety, then this step is a
CCP for the specified hazard.

 Task 8 - Establish critical limits for each CCP - (Principle 3)

Critical limits must be specified and validated for each CCP. Criteria often used include
measurements of temperature, time, moisture level, pH, water activity, and sensory parameters such as
visual appearance. In the case of mycotoxins for example, they may include the moisture content or the
temperature of the commodity. All critical limits, and the associated permissible tolerances, must be
documented in the HACCP Plan Worksheet, and included as specifications in operating procedures and
work instructions.

 Task 9 - Establish a monitoring procedure - (Principle 4)

Monitoring is the mechanism for confirming that critical limits at each CCP are being met. The
method chosen for monitoring must be sensitive and produce a rapid result so that trained operatives
are able to detect any loss of control of the step. This is imperative so that corrective action can be
taken as quickly as possible so that loss of product will be avoided or minimized. Monitoring can be
carried out by observation or by measurement, on samples taken in accordance with a statistically
based sampling plan. Monitoring by visual observation is basic but gives rapid results, and can therefore
be acted upon quickly. The most common measurements taken are time, temperature and moisture
content.

 Task 10 - Establish corrective action - (Principle 5)

If monitoring indicates that critical limits are not being met, thus demonstrating that the process
is out of control, corrective action must be taken immediately. The corrective action should take into
account the worst case scenario, but must also be based on the assessment of hazards, risk and severity,
and on the final use of the product. Operatives responsible for monitoring CCPs should be familiar with
and have received comprehensive training in how to effect a corrective action. Corrective actions must
ensure that the CCP has been brought back under control. They must also include appropriate
disposition of any affected commodity or product. Whenever possible an alarm system should be
introduced which will activate when monitoring indicates that the critical limit is being approached.
Corrective action can then be applied to pre-empt a deviation and prevent the need for any product
disposition.

 Task 11 - Verify the HACCP plan - (Principle 6)

Once the HACCP plan has been drawn up, and all of the CCPs have been validated, then the
complete plan must be verified. Once the HACCP plan is in routine operation, it must be verified and
reviewed at regular intervals. This should be a task of the person charged with the responsibility for that
particular component of the commodity system The appropriateness of CCPs and control measures can
thus be determined, and the extent and effectiveness of monitoring can be verified. Microbiological
and/or alternative chemical tests can be used to confirm that the plan is in control and the product is
meeting customer specifications. A formal internal auditing plan of the system will also demonstrate an
ongoing commitment to keep the HACCP plan up to date, as well as representing an essential
verification activity.

Ways in which the system can be verified include:

 collecting samples for analysis by a method different from the monitoring procedure

 asking questions of staff, especially CCP monitors

 observing operations at CCPs

 formal audit by independent person

It is important to remember that the HACCP system is set up for a particular formulation of
product handled and processed in a given way.

 Task 12 - Keep record - (Principle 7)

Record keeping is an essential part of the HACCP process. It demonstrates that the correct
procedures have been followed from the start to the end of the process, offering product traceability. It
provides a record of compliance with the critical limits set, and can be used to identify problem areas.
Furthermore, the documentation can be used by a company as evidence of 'Due Diligence Defence' as
required, for instance, by the Food Safety Act 1990 (HMSO), in the UK.

Records that should be kept include: all processes and procedures linked to GMP, GHP, CCP
monitoring, deviations, and corrective actions.

Documents should also include those that recorded the original HACCP study, e.g. hazard
identification and selection of critical limits, but the bulk of the documentation will be records
concerned with the monitoring of CCPs and corrective actions taken. Record keeping can be carried out
in a number of ways, ranging from simple check-lists, to records and control charts. Manual and
computer records are equally acceptable, but a documentation method should be designed that is
appropriate for the size and nature of the enterprise.
Food Safety and Inspection Service

Background

 Although the HACCP regulations were implemented over 15 years ago, FSIS has found through
Food Safety Assessments (FSAs) that establishments have not complied with the initial
validation requirement.

 In particular, establishments have not collected the necessary initial in-plant validation data
demonstrating that the HACCP system is functioning as intended.

 Therefore, FSIS determined that additional initial validation guidance is needed.

In March 2010, FSIS posted on its Web site an initial draft of the HACCP Systems Validation
Compliance Guideline. Since then, FSIS has revised the guidance document several times in response to
public comment. The final version has now been published.

Implemenation

 FSIS will provide further instructions and training regarding enforcement activities related to
validation data in subsequent issuances.

There are two elements to initial validation:

1. Scientific Support Documentation (Design)

2. Initial in-plant Demonstration Data (Execution)

• Requirements related to scientific support and initial in-plant validation data are being
verified during the Hazard Analysis Verification (HAV) task
 • In most cases, initial in-plant validation data will consist of data related to critical
operational parameters

What is FSIS’ Statutory Authority (FMIA/PPIA) to Require Initial Validation?

 Under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA),
meat and poultry establishments inspected by FSIS are required to maintain sanitary conditions
sufficient to prevent contamination of products.

 HACCP and sanitation regulations are sanitary measures. To ensure products are handled and
held in a sanitary manner, establishments must follow the HACCP and sanitation regulations.

What is Required?

9 CFR 417.4(a)

“Every establishment shall validate the HACCP plan’s adequacy in controlling the food
safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively
implemented.”

9 CFR 417.4(a)(1)

• “Initial Validation. Upon completion of the hazard analysis and development of the
HACCP plan, the establishment shall conduct activities designed to determine that the
HACCP plan is functioning as intended. During this HACCP plan validation period, the
establishment shall repeatedly test the adequacy of the CCP’s, critical limits, monitoring
and recordkeeping procedures, and corrective actions set forth in the HACCP plan.
Validation also encompasses reviews of the records themselves, routinely generated by
the HACCP system, in the context of other validation activities.”

Time Frame for an Establishing to complete initial validation

• New establishments are issued a conditional grant of inspection for a period up to 90 days in
accordance with 9 CFR 304.3(a) and 381.22(a) during which they must complete initial validation
as required in 9 CFR 417.4.

9 CFR 304.3(a) and 381.22(a)

“Condition for Receiving Inspection”

(a) State “ Before being granted Federal inspection, an establishment shall have developed written
sanitation standard operating procedures.

 Additionally, 9 CFR 304.3(a) and 381.22(a) require establishments producing a new product to
complete the initial validation of the new HACCP plan as required in 9 CFR 417.4(a)(1) during a
period not to exceed 90 days after the date the new product is produced for distribution in
commerce

 Consistent with these requirements, in-plant validation data should encompass the first 90
calendar days of an establishment’s processing experience with a modified HACCP plan based
on a reassessment as per 9 CFR 417.4(a)(3).
Initial Validation vs. Ongoing Verification

• Initial validation should be a distinct function from ongoing verification.

• During the 90 calendar day initial validation period after completing the hazard analysis and
developing the HACCP system, establishments validate the adequacy of their HACCP system.

• Following the 90 calendar day initial validation period, an establishment uses its findings from
the initial validation period to fully implement its system and solidify its monitoring and on-
going verification procedures and frequencies.

Initial Validation vs. Ongoing Verification

What are the Next Step for Implementation?

 - Establishments will be given time (until January 4, 2016 or April 4, 2016 depending on
their size) to collect the necessary initial in-plant validation data.

 FSIS will issue further instructions to IPP on how and when to document noncompliance
if an establishment lacks initial in-plant validation data.

 In the meantime, IPP are to continue to verify initial validation requirements following
the instructions in FSIS Directive 5000.6 Performance of the Hazard Analysis Verification
(HAV) Task and are not to cite the lack of in-plant validation data as the only reason for
the documentation of noncompliance.
What are the Key Points to Take Away?

• Initial validation encompasses activities designed to determine whether the entire HACCP
system is functioning as intended.

• There are two elements to initial validation:

– Element 1: Scientific Support Documentation (Design)

– Element 2: Initial in-plant Demonstration Data (Execution)

– By ensuring that the HACCP system is designed and executed properly, establishments
can reduce the likelihood for product contamination and food borne illnesses in the
future.

What are the Key Points to Take Away?

• Establishments are being given time to assemble the required initial in-plant validation data.

• In most cases, initial in-plant validation data will consist of data related to critical operational
parameters (not microbiological data).

• IPP are not to cite the lack of in-plant validation data as the only reason for the documentation
of noncompliance until instructions are provided in a future issuance.