Websites: FDA Flashcards
(81 cards)
1
Q
What is FDPB?
A
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).
2
Q
The Food Defense Plan Builder guides the user through the following sections:
A
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
3
Q
What is the aim of the FDA Food Safety Modernization Act (FSMA)
A
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.]
4
Q
FDA Food Safety Modernization Act (FSMA) strategies (broadly speaking)
A
Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.
5
Q
When was the FDA Food Safety Modernization Act (FSMA) issued?
A
The proposed rule was issued in December 2013.
6
Q
Who is covered by the FDA Food Safety Modernization Act (FSMA)
A
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.
7
Q
Key provisions of the FDA FSMA
A
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.
8
Q
Compliance date for the FDA FSMA
A
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.
9
Q
Exceptions FDA FSMA
A
- 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.
10
Q
What is the NACMCF?
A
National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is an advisory committee chartered under the U.S. Department of Agriculture (USDA)
11
Q
Participants in the NACMCF
A
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.
12
Q
What is a CCP Decision Tree?
A
A sequence of questions to assist in determining whether a control point is a CCP.
13
Q
HACCP: Control
A
(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.
14
Q
Control Measure:
A
Any action or activity that can be used to prevent, eliminate or reduce a significant hazard.
15
Q
Control Point:
A
Any step at which biological, chemical, or physical factors can be controlled.
16
Q
Corrective Action:
A
Procedures followed when a deviation occurs.
17
Q
Criterion:
A
A requirement on which a judgement or decision can be based.
18
Q
Critical Control Point:
A
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.
19
Q
Critical Limit:
A
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.
20
Q
Deviation in HACCP:
A
Failure to meet a critical limit.
21
Q
HACCP Plan:
A
The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.
22
Q
Hazard:
A
A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.
23
Q
Hazard Analysis:
A
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.
24
Q
Monitoring:
A
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.
25
Prerequisite Programs:
Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.
26
HACCP Step:
A point, procedure, operation or stage in the food system from primary production to final consumption.
27
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.
28
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.
29
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.
30
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.
31
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?
32
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
```
33
Where can 3-monochloropropane-1,2-diol esters (3-MCPDE) and glycidyl esters (GE) be found?
3-monochloropropane-1,2-diol esters (3-MCPDE) and glycidyl esters (GE) are contaminants that can occur in edible oils, such as vegetable oils, and foods made from these oils.
The highest concentrations typically occur in refined palm oil and palm olein oil, and other refined vegetable oils (such as safflower, coconut, sunflower, and soybean oils) and refined marine oils (such as fish oils). Refined vegetable oils are a major component of infant formula
34
Health efects of 3-MCPD ?
3-MCPD caused adverse effects on kidneys and male reproductive organs, and both 3-MCPD and glycidol caused cancer
35
Population more at risk of 3-MCPD and glycidyl esters
Infants
36
What is 4-methylimidazole (4-MEI)?
4-methylimidazole (4-MEI) is a chemical compound that forms as a byproduct at low levels in some foods and beverages during the normal cooking process. For example, 4-MEI may form when coffee beans are roasted and when meats are roasted or grilled. 4-MEI also forms during the manufacturing of certain types of caramel coloring (known as Class III and Class IV caramel coloring). Class III and Class IV caramel coloring are the most commonly used food color additives by volume
37
Is there a risk from eating foods that contain 4-MEI?
Based on current science, the FDA has no reason to believe that there are any immediate or short-term health risks presented by 4-MEI at the levels expected in food.
38
What about studies that show 4-MEI to be a carcinogen?
Has 4-MEI been shown to cause other toxic effects?
In 2007, the National Toxicology Program (NTP) issued reports summarizing the results of toxicological testing conducted on 4-MEI in rats and mice. A 2-year study in rats was inconclusive regarding carcinogenicity, but a 2-year mouse study showed an increased incidence of certain lung tumors. These NTP studies were conducted in rodents at levels of 4-MEI that far exceed current estimates of human exposure to 4-MEI from the consumption of food with or without the addition of Class III or Class IV caramel coloring.
Has 4-MEI been shown to cause other toxic effects?
In March 2020, NTP published the results of a multi-generation reproductive and developmental study on 4-MEI in rats. These types of toxicity studies are conducted to determine if exposure to a substance is associated with changes in reproduction, fertility, and development in the rats’ offspring. This study showed reproductive and developmental effects in male and female rats at the levels tested, however, the doses used in the study were similar to those used in the earlier carcinogenicity studies and similarly far exceed current estimates of human exposure to 4-MEI from foods.
39
Does the FDA require manufacturers to disclose whether food products contain Class III and Class IV caramel coloring?
No.
The FDA’s regulations require that the labels of food containing non-certified color additives, such as caramel coloring, declare the color additives in the ingredients statement either by name or with a general term such as “artificial color” or “color added” unless otherwise indicated.
There is no requirement in FDA’s regulations that the ingredient statement on the label of foods that contain Class III or Class IV caramel coloring list the color additive by name or type.
40
Can 4-MEI be eliminated from food products?
Eliminating 4-MEI in food is not feasible because it is formed during normal cooking processes. However, there are examples of manufacturers of Class III and IV caramel coloring who have taken steps to reduce the levels of 4-MEI in their products
41
What is acrylamide
Acrylamide is a substance that forms through a natural chemical reaction between sugars and asparagine, an amino acid, in plant-based foods – including potato and cereal-grain-based foods. Acrylamide forms during high-temperature cooking, such as frying, roasting, and baking.
Acrylamide forms in foods from a chemical reaction between asparagine, an amino acid, and
reducing sugars such as glucose and fructose. This reaction is part of the Maillard reaction, which leads to color, flavor, and aroma changes in cooked foods (Refs. 2-3, 7). Acrylamide formation usually occurs at elevated temperatures used when frying or baking (above 120
°C (248 °F)) and in low moisture conditions, although acrylamide has also been identified in some fruit and vegetable products heated at lower temperatures or higher moisture conditions (Refs. 8-11). Also, acrylamide formation occurs primarily in plant-based foods,
notably potato products such as french fries and potato chips; cereal- grain-based foods such
as cookies, crackers, breakfast cereals, and toasted bread; and coffee. Acrylamide is also found in cigarette smoke and is produced industrially for use in products such as plastics, grouts, water treatment products, and cosmetics.
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Health Risks from Acrylamide Exposure
Acrylamide in food is a concern because it can cause cancer in laboratory animals at high doses, and is “reasonably anticipated to be a human carcinogen.
Acrylamide exposure can be detected by testing for the presence of acrylamide markers in the blood. According to scientists at the Centers for Disease Control and Prevention, markers of acrylamide exposure can be found in the blood of 99.9% of the U.S. population; however, finding these markers does not imply that their presence will result in adverse health effects.
43
Persons Covered by the Requirements of the Egg Rule (21 CFR 118.1)
You are subject to the egg rule if you are a shell egg producer with 3,000 or more laying hens at a particular farm that does not sell all of your eggs directly to consumers and that produces shell eggs for the table market. You are also subject to the refrigeration requirements of the egg rule if you transport or hold shell eggs for shell egg processing or egg products facilities in instances where those eggs come from farms with 3,000 or more laying hens.
(21 CFR 118.1)
44
Persons Exempted by the Requirements of the Egg Rule (21 CFR 118.1)
You are exempt from the egg rule if you fall into any of the following categories:
Persons who do not produce eggs for the table egg market and who do not hold or transport shell eggs for shell egg processing or egg products facilities;
Egg producers with fewer than 3,000 laying hens at a particular farm;
Egg producers who sell all of their eggs directly to consumers; and
Persons who hold or transport shell eggs for shell egg processing or egg products facilities in instances where the eggs originate from a farm with fewer than 3,000 laying hens.
(21 CFR 118.1)
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B. Persons Covered by the Requirements of the Egg Rule (21 CFR 118.1)
3. Must I comply with all the requirements of the egg rule if all eggs from my farm are treated in a manner that achieves at least a 5-log destruction of SE for shell eggs or, for egg products, processed in accordance with the Egg Products Inspection Act?
No. You must comply only with the refrigeration requirements in § 118.4(e) for production of eggs on that farm and with the registration requirements in § 118.11. (21 CFR 118.1(a) (2))
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B. Persons Covered by the Requirements of the Egg Rule (21 CFR 118.1)
4. Am I covered by the egg rule if my eggs are sold only within my state or I transport eggs only within the same state or I hold eggs for sale only within the same state?
Yes. The egg rule applies regardless of whether the eggs are produced and sold within the same state or sold in interstate commerce.
(74 FR 33030 at 33050; July 9, 2009)
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B. Persons Covered by the Requirements of the Egg Rule (21 CFR 118.1)
5. Are eggs produced in foreign countries and imported into the United States covered under the egg rule?
Yes. Eggs imported into the United States must comply with the same requirements as those produced domestically.
48
D. Salmonella Enteritidis (SE) Prevention Measures (21 CFR 118.4)
Pullets
1. What requirements must I follow when procuring or raising pullets that will become layers on my farm?
You must procure pullets that are SE monitored or raise pullets under SE monitored conditions.
(21 CFR 118.4 (a))
49
D. Salmonella Enteritidis (SE) Prevention Measures (21 CFR 118.4)
Pullets
2. What does “SE monitored” mean?
“SE monitored” means the pullets are raised under SE control conditions that prevent SE, including the following:
Chicks are procured from SE-monitored breeder flocks that meet the National Poultry Improvement Plan's standards for “U.S. S. Enteritidis Clean” status (9 CFR 145.23(d)) or equivalent standard;
The pullet environment is tested for SE when pullets are 14 to 16 weeks of age;
If the environmental test is negative, you do not need to perform any additional testing of those birds or their environment until the environmental test at 40 to 45 weeks of age specified in § 118.5(a); and
If the environmental test is positive, you must begin egg testing, as specified in § 118.6, within 2 weeks of the start of egg laying and you must clean and disinfect the pullet environment to include (1) removing all visible manure; (2) dry cleaning the house to remove dust, feathers, and old feed; and (3) following cleaning, disinfecting the house with spray, aerosol, fumigation, or another appropriate disinfection method.
(21 CFR 118.4(a)(1), (a)(2), and (a)(3))
50
D. Salmonella Enteritidis (SE) Prevention Measures (21 CFR 118.4)
1. What is biosecurity?
Biosecurity is a program, including the limiting of visitors on the farm and in poultry houses, maintaining personnel and equipment practices that will protect against cross contamination from one poultry house to another, preventing stray poultry, wild birds, cats, and other animals from entering poultry houses, and not allowing employees to keep birds at home, to ensure that there is no introduction or transfer of SE onto a farm or among poultry houses.
(21 CFR 118.3)
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D. Salmonella Enteritidis (SE) Prevention Measures (21 CFR 118.4)
2. What must I do to ensure I am in compliance with the biosecurity requirements of the egg rule?
The minimum biosecurity measures you must follow are:
You must limit visitors on your farm and in your poultry houses;
You must maintain practices that will protect against cross contamination when equipment is moved among your poultry houses;
You must maintain practices that will protect against cross contamination when persons move between your poultry houses;
You must prevent stray poultry, wild birds, cats, and other animals from entering your poultry houses; and
You must not allow your employees to keep birds at home.
(21 CFR 118.4 (b)(1), (b)(2), (b)(3), (b)(4), and (b)(5))
52
D. Salmonella Enteritidis (SE) Prevention Measures (21 CFR 118.4)
2. What must I do to ensure I am in compliance with the pest control requirements of the egg rule?
The minimum pest control measures you must follow are:
You must monitor for rodents by visual inspection and mechanical traps or glueboards or another appropriate monitoring method;
When monitoring indicates unacceptable rodent activity within your poultry houses, you must use appropriate methods to achieve satisfactory rodent control;
You must monitor for flies by spot cards, Scudder grills, or sticky traps or another appropriate monitoring method;
When monitoring indicates unacceptable fly activity within your poultry houses, you must use appropriate methods to achieve satisfactory fly control; and
You must remove debris within your poultry houses and vegetation and debris outside your poultry houses that may provide harborage for pests.
(21 CFR 118.4(c)(1), (c)(2) and (c) (3))
53
D. Salmonella Enteritidis (SE) Prevention Measures (21 CFR 118.4)
Biosecurity
1. When am I required to clean and disinfect my poultry houses?
You must clean and disinfect your poultry houses before new laying hens are added to the houses if you have had an environmental test or an egg test that was positive for SE at any point during the life of a flock that was housed in the poultry houses prior to depopulation.
(21 CFR 118.4(d))
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D. Salmonella Enteritidis (SE) Prevention Measures (21 CFR 118.4)
Biosecurity
2. What procedures must I follow when cleaning and disinfecting my poultry houses?
hen cleaning and disinfecting your poultry houses, you must follow these procedures:
You must remove all visible manure;
You must dry clean your positive poultry houses to remove dust, feathers, and old feed; and
Following cleaning, you must disinfect your positive poultry houses with spray, aerosol, fumigation, or another appropriate disinfection method.
(21 CFR 118.4(d)(1), (d)(2), and (d)(3))
55
D. Salmonella Enteritidis (SE) Prevention Measures (21 CFR 118.4)
Refrigeration
1. When must I refrigerate my eggs?
You are required to refrigerate eggs from farms with 3,000 or more laying hens beginning 36 hours after they are laid.
(21 CFR 118.4(e))
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D. Salmonella Enteritidis (SE) Prevention Measures (21 CFR 118.4)
Refrigeration
2. What is the maximum temperature required for holding and transporting eggs that are at least 36 hours old?
The maximum temperature requirement for holding and transporting eggs that are at least 36 hours old is 45 degrees F ambient (air) temperature.
(21 CFR 118.4(e))
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E. Environmental Testing for SE (21 CFR 118.5)
1. Why must I test my poultry house environment for SE?
Environmental testing for SE is one indicator of the effectiveness of your SE prevention plan.
(21 CFR 118.5(a))
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E. Environmental Testing for SE (21 CFR 118.5)
2. When must I test my poultry house environment for SE?
In addition to the required environmental test of the pullet environment when pullets are 14 to 16 weeks of age (§118.4(a)(2)(i)), you must perform environmental testing for SE (as described in §§118.7 and 118.8) in each poultry house when any group of laying hens constituting the flock within the poultry house is 40 to 45 weeks of age (§118.5(a)). If you induce a molt in a flock or a group in a flock, you must perform additional environmental testing for SE in the poultry house at 4 to 6 weeks after the end of each molting process. Each time a flock or group within the flock is molted, you must perform environmental testing in the poultry house at 4 to 6 weeks after the end of the molting process.
(21 CFR 118.5(b))
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E. Environmental Testing for SE (21 CFR 118.5)
3. What am I required to do if my environmental test is negative?
If your environmental test at 40 to 45 weeks is negative and your laying hens do not undergo induced molting, you do not need to perform any additional environmental testing within that poultry house, unless the poultry house contains more than one group of laying hens. If the poultry house contains more than one group of laying hens, you must perform environmental testing on the poultry house when each group of laying hens is 40 to 45 weeks of age. (21 CFR 118.5(a)(1)) If your environmental test at 4 to 6 weeks after the end of the molting process is negative and none of your laying hens in that poultry house is molted again, then you do not need to perform any additional environmental testing in that poultry house.
(21 CFR 118.5(b)(1))
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E. Environmental Testing for SE (21 CFR 118.5)
4. What am I required to do if my environmental test is positive?
If your environmental test at 40 to 45 weeks is positive, then you must:
Review and make any necessary adjustments to your SE prevention plan to ensure that all measures are being properly implemented; AND either
Begin egg testing, as described in § 118.6; OR
Divert eggs to treatment for the life of the flock in that poultry house.
(21 CFR 118.5(a)(2))
If your environmental test at 4 to 6 weeks after the end of a molting process is positive, then you must:
Review and make any necessary adjustments to your SE prevention plan to ensure that all measures are being properly implemented; AND either
Begin egg testing, as described in § 118.6; OR
Divert eggs to treatment for the life of the flock in that poultry house.
(21 CFR 118.5(b)(2))
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E. Environmental Testing for SE (21 CFR 118.5)
5. When must I have the results from egg testing?
You must have results of egg testing within 10-calendar days of receiving notification of the positive environmental test.
(21 CFR 118.5(a)(2)(ii))
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F. Egg Testing for SE (21 CFR 118.6)
1. When must I test eggs for SE?
You must test eggs for SE whenever you have an environmental test positive for SE and you choose not to divert eggs from the flock in the positive house to a treatment for the life of that flock. If the environmental test for pullets at 14 to 16 weeks of age is positive, you must either divert eggs to treatment for the life of that flock or conduct egg testing within 2 weeks of the start of egg laying.
(21 CFR 118.6 (a)(1))
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F. Egg Testing for SE (21 CFR 118.6)
2. How do I test eggs for SE?
You must conduct four egg tests on the flock in the positive poultry house at 2-week intervals.
(21 CFR 118.6 (c))
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F. Egg Testing for SE (21 CFR 118.6)
3. If all four egg tests are negative for SE, am I required to do any further egg testing?
No. If all four egg tests are negative for SE, you do not need to test any more eggs from that flock.
(21 CFR 118.6 (c))
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F. Egg Testing for SE (21 CFR 118.6)
4. What do I do if any of the four egg tests is positive?
If any of the four egg tests is positive for SE, you must divert, upon receiving notification of an SE-positive egg test, all eggs from that flock to treatment for the life of the flock or until four egg tests at 2-week intervals are negative for SE.
(21 CFR 118.6 (c) and (d))
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F. Egg Testing for SE (21 CFR 118.6)
5. What if one of my four egg tests is positive, and I divert to treatment and then later achieve negative results for four egg tests at 2-week intervals?
n this situation, you may return to table egg production, upon receiving notification of a negative result for the fourth egg test. However, you must conduct one egg test per month on that flock for the life of the flock.
(21 CFR 118.6 (e))
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F. Egg Testing for SE (21 CFR 118.6)
6. If all my monthly egg tests are negative for SE, may I continue to supply eggs to the table egg market?
Yes. As long as all of your monthly egg tests are negative for SE, you may continue to supply eggs to the table egg market.
(21 CFR 118.6 (e) (1))
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F. Egg Testing for SE (21 CFR 118.6)
7. What am I required to do if any of my monthly egg tests is positive for SE?
If any of the monthly egg tests is positive for SE, you must divert eggs from the positive flock to treatment for the life of the flock or until four egg tests at 2-week intervals are negative for SE.
(21 CFR 118.6 (e) (2))
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F. Egg Testing for SE (21 CFR 118.6)
8. Am I required to label or otherwise identify eggs I am diverting to treatment?
Yes. If you are diverting eggs, the pallet, case, or other shipping container must be labeled and all documents accompanying the shipment must contain the following statement:
“Federal law requires that these eggs must be treated to achieve at least a 5-log destruction of Salmonella Enteritidis or processed as egg products in accordance with the Egg Products Inspection Act, 21 CFR 118.6(f).”
This statement must be legible and conspicuous.
(21 CFR 118.6 (f))
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G. Sampling Methodology for SE (21 CFR 118.7)
1. How must I sample the poultry house environment for SE?
You must sample the environment within each poultry house using a sampling plan appropriate to the poultry house layout.
(21 CFR 118.7(a))
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G. Sampling Methodology for SE (21 CFR 118.7)
2. How must I sample eggs for SE?
To meet the egg testing requirements of § 118.6 (c), you must collect and deliver for testing a minimum of 1,000 intact eggs representative of a day's production from each positive poultry house. You must collect and test four 1,000-egg samples at 2-week intervals for a total of 4,000 eggs.
To meet the monthly egg testing requirement in § 118.6 (e), you must collect and deliver for testing a minimum of 1,000 intact eggs representative of a day's production from each poultry house (that has had an egg test positive for SE) per month for the life of the flock.
(21 CFR 118.7(b) (1) and (b) (2))
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H. Testing Methodology for SE (21 CFR 118.8)
1. What method must be used to test environmental samples for SE?
Testing to detect SE in environmental samples must be conducted by the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” April 2008, or an equivalent method in accuracy, precision, and sensitivity in detecting SE.
(21 CFR 118.8(a))
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H. Testing Methodology for SE (21 CFR 118.8)
3. What method must be used to test egg samples for SE?
Testing to detect SE in egg samples must be conducted according to Chapter 5 of FDA's Bacteriological Analytical Manual (BAM), December 2007 Edition, or an equivalent method in accuracy, precision, and sensitivity in detecting SE.
(21 CFR 118.8(b))
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I. Administration of the SE Prevention Plan (21 CFR 118.9)
1. How must I administer my SE prevention plan on my farm?
You must have one or more supervisory personnel, who do not have to be on-site employees, to be responsible for ensuring compliance with your farm's SE prevention plan.
(21 CFR 118.9 introduction paragraph)
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I. Administration of the SE Prevention Plan (21 CFR 118.9)
2. What are the qualifications for these supervisory personnel?
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This person (or persons) must have successfully completed training on SE prevention measures for egg production that is equivalent to that received under a standardized curriculum recognized by the Food and Drug Administration or must be otherwise qualified through job experience to administer the SE prevention measures. Job experience will qualify this person to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum.
(21 CFR 118.9 introduction paragraph)
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I. Administration of the SE Prevention Plan (21 CFR 118.9)
3. What are these supervisory personnel responsibilities?
This person is responsible for:
Developing and implementing an SE prevention plan that is appropriate for your specific farm and meets the requirements of §118.4;
Reassessing and modifying the SE prevention plan as necessary to ensure that the requirements in § 118.4 are met; and
Reviewing records created under §118.10. (This person does not need to have performed the monitoring or created the records.)
(21 CFR 118.9 (a), (b), and (c))
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J. Recordkeeping Requirements for the SE Prevention Plan (21 CFR 118.10)
1. What records am I required to make and keep?
equired Records Documenting Compliance With…
Written SE prevention plan 21 CFR 118.4
Documentation that pullets were “SE monitored” or were raised under “SE monitored” conditions, including environmental testing records for pullets 21 CFR 118.4(a)
Records documenting compliance with biosecurity measures 21 CFR 118.4 (b)
Records documenting compliance with rodent and other pest control measures 21 CFR 118.4 (c)
Records documenting compliance with cleaning and disinfection procedures performed at depopulation, when applicable 21 CFR 118.4(d)
Records documenting compliance with refrigeration requirements 21 CFR 118.4(e)
Records documenting compliance with environmental and egg sampling procedures, when applicable 21 CFR 118.7
Results of SE testing, when applicable, performed under § 118.8 21 CFR 118.4(a)(2)
21 CFR 118.5
21 CFR 118.6
Diversion of eggs, if applicable 21 CFR 118.6
All eggs at a particular farm being given a treatment 21 CFR 118.1(a)(2)
Records of review and of modifications of the SE prevention plan and corrective actions taken 21 CFR 118.9
(21 CFR 118.10(a))
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J. Recordkeeping Requirements for the SE Prevention Plan (21 CFR 118.10)
2. What information must I include on my records?
You must include the following information on all records required under § 118.10:
Your name and the location of your farm,
The date and time of the activity that the record reflects,
The signature or initials of the person performing the operation or creating the record, and
The actual values observed, if applicable.
The written SE prevention plan must be dated and carry the signature(s) (not initials) of the person(s) who administers the plan as described in § 118.9.
(21 CFR 118.10 (b)(1), (b)(2) and (b)(3))
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J. Recordkeeping Requirements for the SE Prevention Plan (21 CFR 118.10)
3. Can I enter information on required records at the end of the day or the end of the week?
No. Data and information reflecting compliance activities must be entered on records at the time the activity is performed or observed.
(21 CFR 118.10 (b)(4))
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J. Recordkeeping Requirements for the SE Prevention Plan (21 CFR 118.10)
4. How long must I retain required records?
You must retain all records required by § 118.10 at your place of business, unless stored offsite (see below), for 1 year after the flock to which they pertain has been taken permanently out of production.
(21 CFR 118.10 (c))
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K. Registration Requirements
1. Who must register?
Shell egg producers with 3000 or more laying hens at a particular farm that does not sell all their eggs directly to consumers and that produces shell eggs for the table market are required to register their farms with FDA.
(21 CFR 118.11 (a))
