Websites: FDA Flashcards
What is FDPB?
The Food Defense Plan Builder (FDPB) version 2.0 is a user-friendly tool designed by FDA to help owners and operators of a food facility in the development of a food defense plan that is specific to their facility and may assist them with meeting the requirements of the Mitigation Strategies to Prevent Food Against Intentional Adulteration regulation (21 CFR Part 121) (IA rule).
The Food Defense Plan Builder guides the user through the following sections:
Facility Information Product/Process Descriptions Vulnerability Assessments Mitigation Strategies Food Defense Monitoring Procedures Food Defense Corrective Actions Procedures Food Defense Verification Procedures Supporting Documents Food Defense Plan Signatures
What is the aim of the FDA Food Safety Modernization Act (FSMA)
The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.
[Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.]
FDA Food Safety Modernization Act (FSMA) strategies (broadly speaking)
Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.
When was the FDA Food Safety Modernization Act (FSMA) issued?
The proposed rule was issued in December 2013.
Who is covered by the FDA Food Safety Modernization Act (FSMA)
With some exceptions, this rule applies to both domestic and foreign companies that are required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act.
This rule is designed to primarily cover large companies whose products reach many people, exempting smaller companies. There are 3,400 covered firms that operate 9,800 food facilities.
It does not cover farms.
Key provisions of the FDA FSMA
Companies are required to prepare and implement a food defense plan. This written plan must identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification. A reanalysis is required every three years or when certain criteria are met, including mitigation strategies that are determined to be improperly implemented.
Vulnerability assessment: This is the identification of vulnerabilities and actionable process steps for each type of food manufactured, processed, packed or held at the food facility. For each point, step, or procedure in the facility’s process, these elements must be evaluated:
- -> The severity and scale of the potential impact on public health. This would include such considerations as the volume of product, the number of servings, the number of exposures, how fast the food moves through the distribution system, potential agents of concern and the infectious/lethal dose of each; and the possible number of illnesses and deaths.
- -> The degree of physical access to the product. Things to be considered would include the presence of such physical barriers as gates, railings, doors, lids, seals and shields.
- -> The ability to successfully contaminate the product.
Mitigation strategies: These should be identified and implemented at each actionable process step to provide assurances that vulnerabilities will be minimized or prevented.
Monitoring: Establishing and implementing procedures, including the frequency with which they are to be performed, for monitoring the mitigation strategies.
Corrective actions: The response if mitigation strategies are not properly implemented.
Verification: Verification activities would ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made.
Training and recordkeeping: Facilities must ensure that personnel assigned to the vulnerable areas receive appropriate training; facilities must maintain records for food defense monitoring, corrective actions, and verification activities.
Compliance date for the FDA FSMA
Very Small Businesses— (< $10,000,000, per year): five years after the publication of the final rule.
Small Businesses—(< 500 employees) would have to comply four years after the publication of the final rule.
Other Businesses—would have to comply three years after the publication of the final rule.
Exceptions FDA FSMA
- A very small business.
- The holding of food, except the holding of food in liquid storage tanks.
- The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact
- Activities that fall within the definition of “farm”
- Manufacturing, processing, packing, or holding of food for animals
- Alcoholic beverages under certain conditions
- On-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices. The exemption applies if such activities are the only activities conducted by the business subject to the rule. These foods include certain types of eggs, and certain types of game meats.
What is the NACMCF?
National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is an advisory committee chartered under the U.S. Department of Agriculture (USDA)
Participants in the NACMCF
The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is comprised of participants from the:
- USDA (Food Safety and Inspection Service),
- Department of Health and Human Services (U.S. Food and Drug Administration and the Centers for Disease Control and Prevention)
- the Department of Commerce (National Marine Fisheries Service),
- the Department of Defense (Office of the Army Surgeon General),
- academia, industry and state employees.
What is a CCP Decision Tree?
A sequence of questions to assist in determining whether a control point is a CCP.
HACCP: Control
(a) To manage the conditions of an operation to maintain compliance with established criteria.
(b) The state where correct procedures are being followed and criteria are being met.
Control Measure:
Any action or activity that can be used to prevent, eliminate or reduce a significant hazard.
Control Point:
Any step at which biological, chemical, or physical factors can be controlled.
Corrective Action:
Procedures followed when a deviation occurs.
Criterion:
A requirement on which a judgement or decision can be based.
Critical Control Point:
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.
Critical Limit:
A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard.
Deviation in HACCP:
Failure to meet a critical limit.
HACCP Plan:
The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.
Hazard:
A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.
Hazard Analysis:
The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.
Monitoring:
To conduct 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.
Prerequisite Programs:
Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.
HACCP Step:
A point, procedure, operation or stage in the food system from primary production to final consumption.
HACCP Validation:
That 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.Verification: Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.
HACCP principles:
HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles:
Principle 1: Conduct a hazard analysis.
Principle 2: Determine the critical control points (CCPs).
Principle 3: Establish critical limits.
Principle 4: Establish monitoring procedures.
Principle 5: Establish corrective actions.
Principle 6: Establish verification procedures.
Principle 7: Establish record-keeping and documentation procedures.
Examples of HACCP Records
Ingredients for which critical limits have been established.
Supplier certification records documenting compliance of an ingredient with a critical limit.
Processor audit records verifying supplier compliance.
Storage records (e.g., time, temperature) for when ingredient storage is a CCP.
Processing, storage and distribution records
Information that establishes the efficacy of a CCP to maintain product safety.
Data establishing the safe shelf life of the product; if age of product can affect safety.
Records indicating compliance with critical limits when packaging materials, labeling or sealing specifications are necessary for food safety.
Monitoring records.
Verification records.
Deviation and corrective action records.
Employee training records that are pertinent to CCPs and the HACCP plan.
Documentation of the adequacy of the HACCP plan from a knowledgeable HACCP expert.
Examples of Common Prerequisite Programs
Facilities: The establishment should be located, constructed and maintained according to sanitary design principles. There should be linear product flow and traffic control to minimize cross-contamination from raw to cooked materials.
Supplier Control: Each facility should assure that its suppliers have in place effective GMP and food safety programs. These may be the subject of continuing supplier guarantee and supplier HACCP system verification.
Specifications: There should be written specifications for all ingredients, products, and packaging materials.
Production Equipment: All equipment should be constructed and installed according to sanitary design principles. Preventive maintenance and calibration schedules should be established and documented.
Cleaning and Sanitation: All procedures for cleaning and sanitation of the equipment and the facility should be written and followed. A master sanitation schedule should be in place.
Personal Hygiene: All employees and other persons who enter the manufacturing plant should follow the requirements for personal hygiene.
Training: All employees should receive documented training in personal hygiene, GMP, cleaning and sanitation procedures, personal safety, and their role in the HACCP program.
Chemical Control: Documented procedures must be in place to assure the segregation and proper use of non-food chemicals in the plant. These include cleaning chemicals, fumigants, and pesticides or baits used in or around the plant.
Receiving, Storage and Shipping: All raw materials and products should be stored under sanitary conditions and the proper environmental conditions such as temperature and humidity to assure their safety and wholesomeness
Traceability and Recall: All raw materials and products should be lot-coded and a recall system in place so that rapid and complete traces and recalls can be done when a product retrieval is necessary.
Pest Control: Effective pest control programs should be in place.
Other examples of prerequisite programs might include quality assurance procedures; standard operating procedures for sanitation, processes, product formulations and recipes; glass control; procedures for receiving, storage and shipping; labeling; and employee food and ingredient handling practices.
Examples of Questions to be Considered When Conducting a Hazard Analysis
Ingredients
Does the food contain any sensitive ingredients that may present microbiological hazards (e.g., Salmonella, Staphylococcus aureus); chemical hazards (e.g., aflatoxin, antibiotic or pesticide residues); or physical hazards (stones, glass, metal)?
Are potable water, ice and steam used in formulating or in handling the food?
What are the sources (e.g., geographical region, specific supplier)
Intrinsic Factors - Physical characteristics and composition (e.g., pH, type of acidulants, fermentable carbohydrate, water activity, preservatives) of the food during and after processing.
What hazards may result if the food composition is not controlled?
Does the food permit survival or multiplication of pathogens and/or toxin formation in the food during processing?
Will the food permit survival or multiplication of pathogens and/or toxin formation during subsequent steps in the food chain?
Are there other similar products in the market place? What has been the safety record for these products? What hazards have been associated with the products?
Procedures used for processing
Does the process include a controllable processing step that destroys pathogens? If so, which pathogens? Consider both vegetative cells and spores.
If the product is subject to recontamination between processing (e.g., cooking, pasteurizing) and packaging which biological, chemical or physical hazards are likely to occur?
Microbial content of the food
What is the normal microbial content of the food?
Does the microbial population change during the normal time the food is stored prior to consumption?
Does the subsequent change in microbial population alter the safety of the food?
Do the answers to the above questions indicate a high likelihood of certain biological hazards?
Facility design
Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat (RTE) foods if this is important to food safety? If not, what hazards should be considered as possible contaminants of the RTE products?
Is positive air pressure maintained in product packaging areas? Is this essential for product safety?
Is the traffic pattern for people and moving equipment a significant source of contamination?
Equipment design and use
Will the equipment provide the time-temperature control that is necessary for safe food?
Is the equipment properly sized for the volume of food that will be processed?
Can the equipment be sufficiently controlled so that the variation in performance will be within the tolerances required to produce a safe food?
Is the equipment reliable or is it prone to frequent breakdowns?
Is the equipment designed so that it can be easily cleaned and sanitized?
Is there a chance for product contamination with hazardous substances; e.g., glass?
What product safety devices are used to enhance consumer safety?
metal detectors
magnets
sifters
filters
screens
thermometers
bone removal devices
dud detectors
To what degree will normal equipment wear affect the likely occurrence of a physical hazard (e.g., metal) in the product?
Are allergen protocols needed in using equipment for different products?
Packaging
Does the method of packaging affect the multiplication of microbial pathogens and/or the formation of toxins?
Is the package clearly labeled “Keep Refrigerated” if this is required for safety?
Does the package include instructions for the safe handling and preparation of the food by the end user?
Is the packaging material resistant to damage thereby preventing the entrance of microbial contamination?
Are tamper-evident packaging features used?
Is each package and case legibly and accurately coded?
Does each package contain the proper label?
Are potential allergens in the ingredients included in the list of ingredients on the label?
Sanitation
Can sanitation have an impact upon the safety of the food that is being processed?
Can the facility and equipment be easily cleaned and sanitized to permit the safe handling of food?
Is it possible to provide sanitary conditions consistently and adequately to assure safe foods?
Employee health, hygiene and education
Can employee health or personal hygiene practices impact upon the safety of the food being processed?
Do the employees understand the process and the factors they must control to assure the preparation of safe foods?
Will the employees inform management of a problem which could impact upon safety of food?
Conditions of storage between packaging and the end user
What is the likelihood that the food will be improperly stored at the wrong temperature?
Would an error in improper storage lead to a microbiologically unsafe food?
Intended use
Will the food be heated by the consumer?
Will there likely be leftovers?
Intended consumer
Is the food intended for the general public?
Is the food intended for consumption by a population with increased susceptibility to illness (e.g., infants, the aged, the infirmed, immunocompromised individuals)?
Is the food to be used for institutional feeding or the home?
List of chemicals of concern to FDA
3-Monochloropropane-1,2-diol (MCPD) Esters and Glycidyl Esters 4-methylimidazole (4-MEI) Acrylamide Benzene Dioxins and PCBs Ethyl Carbamate Furan Melamine Per- and Polyfluoroalkyl Substances (PFAS) Perchlorate Radionuclides Toxic elements in Foods & foodware
