Test 1

Test 1 will be conducted in TP on 02/06/07 (Sat) for 2 hrs...
- Need 2 bring SOFA & other ref for regulations..
- Can bring materials for own references

Additional info on Food Product Recall

1. Recall - Background and Objectives

Recall is an effective method of removing or correcting violative products that may represent a health hazard to the consumer or user. It is an action taken by a manufacturer, distributor, or importer to carry out their responsibility to protect the public health and well-being.
During recalls, the primary role of the Health Protection Branch is to closely monitor the effectiveness of the firm's recall actions and to provide scientific, technical and operational advice. If a recalling firm's performance is deemed to be inadequate, the Branch is prepared to take appropriate action to remove the product from sale or use. A firm's recall does not preclude enforcement actions being taken by the Branch, as deemed appropriate, either during or following the completion of the recall.

2. Definitions

"Product" means any domestic or imported food, drug, cosmetic, device, radiation emitting device, and any advertisement thereof,as defined under the Food and Drugs Act and the Radiation Emitting Devices Act.

1. "Recall" with respect to a product, other than a medical device, means a firm's removal from further sale or use, or correction, of a marketed product that violates legislation administered by the Health Protection Branch.

2. "Recall" with respect to a medical device that has been marketed means any action taken in respect of the device by the manufacturer or importer thereof after becoming aware that the device is or may be hazardous to health, fails or may fail to conform with any claims made by the manufacturer or importer relating to the effectiveness, benefits, performance characteristics or safety of the device, or does not comply with the Food and Drugs Act or Medical Devices Regulations to recall or correct the device or to notify the owner or user of the device of the defectiveness thereof

3. The definition of "Recall" does not include a "product withdrawal" or a "stock recovery".

"Correction" means repair, modification, adjustment, relabelling, or inspection (including patient monitoring) of a product without its physical removal to some other location.

"Recalling firm" means the firm that initiates a recall. It is usually the firm that has primary responsibility for the manufacture/import and marketing of the product to be recalled.
"Consignee" means anyone who received, purchased, or used the product being recalled.
"Product withdrawal" means a firm's removal from further sale or use, or correction of a marketed product that does not violate legislation administered by the Health Protection Branch. It is not considered to be a recall.

"Stock recovery" means a firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm. It is not considered to be a recall.
"Recall strategy" means a planned specific course of action to be taken in conducting a specific recall, which addresses itself to matters such as the depth of recall, need for public warnings, and extent or effectiveness checks for the recall.
"Recall classification" means the numerical designation, i.e. Class I, Class II or Class III, assigned by the Health Protection Branch to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.

Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Class II is a situation in which the use of, or exposure to, a violative product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III is a situation in which the use of, or exposure to, a violative product is not likely to cause any adverse health consequences.

3. Recall Notification

It is imperative that before or upon initiating a recall, the recalling firm notifies the Health Protection Branch. The basic information required includes the following:

The name of the recalled product and, where applicable, the identifying model designation, serial number, code, lot number and any other means of identification.
The total quantity of the recalled product originally in his possession.
The total quantity of the recalled product that had been distributed up to the time of the recall.
Area of the distribution of the recalled product by province and, if exported, by country.
The quantity of the recalled product still in his possession.
The reason for initiating the recall.
This information is usually provided verbally but it should be confirmed in writing. For drugs and medical devices, please refer to the specific recall notification requirements in the Food and Drug Regulations and the Medical Devices Regulations respectively.

4. Health Hazard Evaluation and Recall Classification

Before initiating a recall, the firm will normally gather, correlate and evaluate all known information on the nature and extent of the reputed health risk. An evaluation of the health hazard presented by a product being recalled or considered for recall will also be conducted by Health Protection Branch scientists and will take into account, but need not be limited to, the following factors:

1. Whether any disease or injuries have already occurred from the use of the product.
2. Assessment of hazard to various segments of the population, e.g., children, surgical patients, etc., who are expected to be exposed to the product being considered, with particular attention paid to the hazard to those individuals who may be at greatest risk.
3. Assessment of the degree of seriousness of the health hazard to which the population at risk would be exposed.
4. Assessment of the likelihood of occurrence of the hazard.
5. Assessment of the consequences (immediate or long-range) of occurrence of the hazard.

Any conclusion shall be supported as completely as possible by scientific documentation and/or statements that the conclusion is the opinion of the individual(s) making the health hazard determination. The recalling firm is given every opportunity to contribute to the information on which the health hazard evaluation is made by the Health Protection Branch who, on the basis of this determination, assigns the recall a classification, i.e., Class I, Class II or Class III, to indicate the relative degree of health hazard of the product being recalled or considered for recall.

5. Recall Strategy

a. General

- A recall strategy that takes into account the following factors will be developed by the recalling firm to suit the individual circumstances of the particular recall:
- Results of health hazard evaluation.
- Ease in identifying the product.
- Degree to which the product's deficiency is obvious to the consumer or user.
- Degree to which the product remains unused in the marketplace.
- Continued availability of essential products.

The Health Protection Branch will provide scientific, technical and operational advice to the recalling firm in the development of the recall strategy as well as evaluate its effectiveness and recommend changes, as deemed appropriate. Additional investigation, analysis and compliance actions may also be carried out by the Branch.

b. Elements of a recall strategy

A recall strategy will address the following elements regarding the conduct of the recall:
Depth of recall - Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, as follows:

Consumer or user level, which may vary with product, including any intermediate wholesale or retail level; or Retail level, including any intermediate wholesale level; or Wholesale level.

- Recall Communications - From the recalling firm to its affected accounts.

- Public Warning - The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health. It is reserved for urgent situations (Class I and occasionally Class II Recalls) where other means for preventing use of the recalled product appear inadequate.

The Assistant Deputy Minister decides whether a public recall announcement is mandatory and whether the Health Protection Branch will issue the warning.The recall strategy will specify the type of public warning, for example:

General public warning through the general news media, either national or local as appropriate, or Public warning through specialized news media, e.g., professional, trade or ethnic press, or to specific segments of the population such as physicians, hospitals, etc.

Effectiveness checks - The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action. The method for contacting consignees may be accomplished by personal visits, telephone calls, letters, or a combination thereof. The recalling firm is responsible for conducting effectiveness checks. The firm's recall strategy will specify the method(s) to be used for and the level of effectiveness checks that will be conducted by the recalling firm as follows.

Level A - 100 percent of the total number of consignees to be contacted;
Level B - Some percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater than 10 percent and less than 100 percent of the total number of consignees
Level C - 10 percent or less of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis; or
Level D - No effectiveness checks.

The Health Protection Branch, sometimes assisted by other health agencies, may carry out its own effectiveness checks as part of monitoring the recalling firm's performance. This is a separate exercise which must not be considered as part of, or supplement to, the recalling firm's responsibilities for adequate effectiveness checks.

6. Recall Communications

a. General

A recalling firm is responsible for promptly notifying each of its affected accounts about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall. In general terms, the purpose of a recall communication is to convey:
That the product in question is subject to a recall;
That further distribution or use of any remaining product should cease immediately;
Where applicable and required as part of the recall strategy, that the direct account should in turn notify its accounts that received the product about the recall;
Instructions regarding what to do with the product.

b. Implementation

As determined by the recall strategy, a recall communication can be accomplished by telephone, telex, telegrams, or special delivery letters conspicuously marked, preferably in bold red type, on the letter and envelope: "DRUG (or FOOD, BIOLOGIC, etc.) RECALL". The letter and the envelope should also be marked: "URGENT" for Class I and Class II recalls. Telephone calls or other personal contacts should ordinarily be confirmed by one of the other above methods and/or documented in an appropriate manner.

c. Content

A recall communication should be written in accordance with the following guidelines:
Be brief and to the point;
Identify clearly the product, size, lot number(s), code(s), or serial number(s) and any other pertinent descriptive information to enable accurate and immediate identification of the product;
Explain concisely the reason for the recall and the hazard involved;
Provide specific instructions on what should be done with respect to the recalled products; and
Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product, e.g., by allowing the recipient to place a collect call to the recalling firm.
The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, follow-up communications should be sent to those who fail to respond to the initial recall communication.

d. Responsibility of recipient

Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees in accordance with paragraphs (b) and (c) of this section.

7. Termination of a Product Recall

A recall will be terminated when the Health Protection Branch and the recalling firms are in agreement that the product subject to the recall has been removed and proper disposition or correction has been made.

8. General Industry Guidance

A recall can be disruptive of a firm's operation and business, but there are several steps a firm can take in advance to minimize this disruptive effect. While the following is provided as guidance, it should be noted that some of it is a requirement under current legislation administered by the Health Protection Branch.
Prepare and maintain a detailed written recall system or plan that will permit a rapid and effective product recall. This would include the identification of all internal and external personnel involved in the recall action and their functions and responsibilities; the channels and means of communication; the control of returned stock, etc.
Use sufficient coding of products to permit positive lot identification and to facilitate effective recall of those lots.
Maintain such product distribution records as are necessary to facilitate location of products that are being recalled. Such records should be maintained for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention.

9. Recall Responsibilities - Health Protection Branch

Recalls will be given high priority at all levels of the Branch. Prompt and complete fulfillment by Branch personnel of their specific recall responsibilities is required. This may require adjusted work hours, stand-by, overtime and sacrifice of scheduled work. The major responsibilities of key personnel are as follows:

REGIONAL RECALL COORDINATORS -FIELD OPERATIONS DIRECTORATE

Provides an early alert on the possibility of Class I and Class II recall situations to the National Recall Coordinator.
Upon a recall initiated in that region, promptly advises a National Recall Coordinator by telephone and submits an initial INFORMATION ON RECALL report to the Operations and Compliance Division by telecopier within 24 hours.
Submits adequate data for the purpose of obtaining health hazard evaluations and recall classifications via the Operations and Compliance Division.
Participates in the development of the recall strategy.

Implements the recall strategy in that region. This includes the co-ordination and allocation of resources, regional work units, Branch dealings with the recalling firm and other agencies, including requirements under working agreements with provincial health departments.
Monitors the effectiveness of the firm's recall actions. Provides scientific and operational advice to the recalling firm, usually via district office.
Provides status reports to the Operations and Compliance Division until a recall is considered as being terminated.

NATIONAL RECALL COORDINATOR -FIELD OPERATIONS DIRECTORATE
Seeks and reviews information on all product recalls. This includes contact with foreign agencies, either directly or through the Department of External Affairs.
Provides an early alert on the possibility of Class I recall situations to the appropriate Bureau Recall Coordinator and Directors-General.
Obtains health hazard evaluations from the other Directorates and participates in the classification of each recall by that Directorate.
Co-ordinates the development of the recall strategy. This includes a decision on whether to recommend to the Director-General of the Field Operations Directorate that a public announcement be mandatory.
Co-ordinates the implementation of the recall strategy. This includes co-ordination of resources and the communication of recall information between regions and with the headquarters contacts of other federal departments.
Maintains liaison with the recall coordinators of the other Directorates and obtains scientific advice as necessary.
Exchanges scientific and operational advice with the regional coordinators as necessary.
In conjunction with the regional coordinators, evaluates the effectiveness of the recall actions.
Provides necessary information to Media Officers and assists in the preparation of departmental news releases.

BUREAU RECALL COORDINATOR - FOOD, DRUG, AND ENVIRONMENTAL
Upon request, provides written health hazard evaluations or re-evaluations to National Recall Coordinator (Field Operations Directorate) and classification of each recall.
Participates in the development of the recall strategy. This includes a decision on whether to recommend to the Director-General that a public announcement be mandatory.
Maintains liaison with the National Recall Coordinator and provides scientific advice as necessary.
Provides scientific information to Media Officers and assists in the preparation of news releases.

MEDIA OFFICER
Prepares and issues Branch public recall announcements in the form of news releases.

DIRECTORS-GENERAL: FOOD, DRUG, AND ENVIRONMENTAL HEALTH DIRECTORATES

On the basis of the health hazard evaluation, decides whether to recommend to the Assistant Deputy Minister that a public announcement be mandatory and the technical content of the announcement.
Approves the content of news releases if prepared by the recalling firm.
Maintains knowledge of all Class I Recalls and others as appropriate.

DIRECTOR-GENERAL: FIELD OPERATIONS DIRECTORATE

On the basis of the operational considerations within the total recall strategy makes recommendations to the Assistant Deputy Minister whether a public announcement is required.
Informs the recalling firm that a public announcement is mandatory, as decided by the Assistant Deputy Minister.
Maintains knowledge of all Class I Recalls and others as appropriate.
Provides operational direction within the Field Operations Directorate as he deems necessary for Class I Recalls.

ASSISTANT DEPUTY MINISTER

Decides whether a public recall announcement be mandatory. Approves HPB news releases.
Maintains knowledge of all Class I Recalls.

Example of Food product Recall

Ohio Department of Agriculture

and

Ohio Department of Health

Governor Bob Taft ODA Director Fred L. Dailey
Lieutenant Governor Bruce Johnson ODH Director J. Nick Baird, M.D.

To: Health Commissioners, Environmental Health Directors, Nursing Directors, ODA Food Safety Specialists, and Other Interested Parties

Subject: Recall Announcement (ODA/ODH) 2006-26

Date: May 24, 2006

Made-Rite Sandwich Company Recalls Sandwiches Because of Possible Health Risk

Ooltewah, TN - Made-Rite Sandwich Company of Ooltewah, TN is recalling approximately
27,000 chicken salad and tuna salad sandwiches because it has the potential to be
contaminated with harmful bacteria. We are recalling these products because one of our
suppliers provided us with an ingredient that was not processed in a manner to prevent the
growth of harmful bacteria. Consumers are warned not to use the product even if it does not
look or smell spoiled.

The products have been sold under the following brands: Great American Deli, Granny
Green and Lil' Cindy's.

Affected product was distributed to FL, AL, MS, LA, GA, AR, TN, GA, NC, SC, VA, KY, OH, IN,
MI and reached consumers through a variety of distribution avenues including retail stores,
vending machines and wholesale distribution centers.
Products are packaged in triangle shaped clear plastic containers with a net weight of 5.0
ounces per sandwich.

Affected products are a potential risk for growth of bacteria due to the under-acidification of
the celery used as an ingredient in the salads. Sandwich code dates include the following:

Tuna Salad 122
Tuna Salad 124
Tuna Salad 130
Chicken Salad 118
Chicken Salad 122
Chicken Salad 124
Chicken Salad 129

No illnesses have been reported to date.
Consumers who have purchased these products are urged to return it to the place of purchase for a full refund. Consumers with questions should contact Made-Rite Sandwich Company at 100-343-1327.

Meat and poultry products

Types of products

Raw meat and poultry products consist of raw products; shelf-stable, raw-salted and salted-cured products (salt pork, dry-cured bacon, country ham); perishable raw-salted and salted-cured products (fresh sausage, chorizo, bratwurst, Polish and Italian sausage); marinated products; and raw breaded products. Ready-to eat products include perishable cooked uncured products (cooked roast beef, cooked pork, cooked turkey); perishable cooked cured products (franks, bologna, ham, and a variety of luncheon meats); canned shelf-stable cured products (Vienna sausages, corned beef, meat spreads, small canned hams, canned sausages with oil and water activity [aW] <0.92, dried beef, and prefried bacon); perishable canned cured products (ham and other cured meats); shelf-stable, canned uncured products (roast beef with gravy,
meat stew, chili, chicken and spaghetti sauce with meat); fermented and acidulated sausages (German and Italian style salamis, pepperoni, Lebanon bologna, and summer sausage); and dried meat products (jerky, beef sticks, basturma, and other dried meats). Because of the complexity of the product/processing matrices, product parameters (moisture protein ratio, aW, and pH) and processing schedules are needed to ascertain whether ready-to-eat products require time/temperature control for safety or are shelf stable.

Microbial concerns

Red meats and poultry come from warm-blooded animals and, as such, their microbial flora is
heterogeneous, consisting of mesophilic and psychrotrophic bacteria. These bacteria include pathogenic species from the animal itself and from the environment, and bacterial species introduced during slaughter and processing of raw products. Raw meat and poultry have an aw >0.99 and a pH range of 5 –7, which is an optimal combination for microbial growth. When red meats and poultry are cooked or processed and subsequently refrigerated, the bacterial load from the raw tissue is greatly reduced, leaving only sporeformers, enterococci, micrococci, and some lactobacilli. In addition, environmental post-processing pathogen contamination can occur and the reduction in competitive bacterial flora may allow for pathogen growth. Some products are shelf stable because they received either a botulinum cook or a lesser cook in combination with other controls, such as acidity or other additives

The principal pathogens of concern are Staphylococcus aureus, enterohemmorrhagic Escherichia coli
(ruminants), Salmonella spp. (all meats), Listeria monocytogenes (all meats), Campylobacter jejuni/coli
(poultry), Yersinia entercolitica (pork), and Clostridium perfringens and Clostridium botulinum (mainly
processed products). There is a particular concern when these species are present and/or can grow in
cooked products without competition.

Effects of processing

Meat and poultry products require a wide array of control measures in their processing. Cured meats and some sausage products utilize additives such as salt, nitrate, nitrite, and sugars with processing procedures such as cooking and smoking. Salt, for example, may restrict bacterial flora to salt-tolerant species.
Smoking and/or cooking will destroy many vegetative cells. However, the processing environment and product handling and packaging may introduce microorganisms, including pathogens, into the packaged product that also must be considered.
While some canned products may be processed as “commercially sterile”, others are canned "semipreserved" and must be stored under refrigeration. Some products utilize a secondary control such as acidity and are shelf stable though not necessarily "commercially sterile." Specific labeling for refrigeration is required on the semi-preserved products that require refrigeration as a control. Pickled products depend on a low pH, absence of oxygen, and the lack of a fermentable sugar to inhibit the growth of most bacteria. Acid-tolerant species may develop, such as certain lactobacilli, and if air is available, certain yeast and molds may grow. The activity of lactic acid bacteria in fermented sausages is desirable and is an integral part of the process control for achieving the desired pH for these products.
Because of the complexities of products and processing, the USDA Food Safety and Inspection Service (FSIS) has provided guidelines for product parameters in its "Food Standards and Labeling Policy Book" (USDA 1996, with change 98-01). The FSIS guidelines include product specifications such as “meat sticks and cheese”, along with general topic categories such as for example "Sausage - Shelf Stable"; “Moisture Protein Ratio –MPR;" and "Moisture Protein Ratio - pH.” These policies must always be considered in conjunction with process controls under the HACCP Rule, 9 C.F.R. 417. A product processed in the retail environment is not covered by this rule; however, the variance requirements of the Food Code should require that meat and poultry products have equivalent product specifications for shelf stability and process records documenting control of hazards.
There is substantial history of safety of meat and poultry products that meet these criteria. In addition to the above criteria, certain combinations of pH, aw, and /or other factors can be used to prevent pathogen level increase when meat products are held at ambient temperatures. Products processed in the retail environment and exempt from the HACCP Rule should also follow these guidelines and maintain records documenting control of hazards.

Time/temperature control

Unless the specific product parameters referenced in the previous section are met, meat and poultry products must be considered as requiring time/temperature control. Raw meat and poultry products currently require safe-handling instruction labeling that includes a time/temperature control provision. For ready-to-eat foods, product parameters and processing schedules are needed to ascertain whether temperature control for safety is required. Post-processing contamination is also an important consideration and should not be overlooked. Because meat offers a rich nutrient media for microbial growth, products that incorporate meat and poultry as ingredients, such as meat salads and meat pastries, also must be considered as requiring time/temperature control.

Fruits and vegetables

Types of products

Fruits are the portions of plants that bear seeds, while vegetables are the edible components of a plant, including the leaves, stalks, roots, tubers, bulbs, flowers, and seeds (ICMSF 1998, p 253). A wide variety of products, including citrus fruits, apples, pears, bananas, tropical fruits, compound fruits (for example, berries), tomatoes, olives, cucumbers, and melons, as well as vegetables ranging from asparagus to zucchini, are available in the market place (ICMSF 1998, p 215-273).
Fruits and vegetables and related products include foods that are sold fresh, minimally processed (for example, cut, sliced, chopped, shredded, or peeled), canned, frozen, juiced, or dried. Some commodities are retained in storage under controlled or modified atmospheres before packaging, while others are packaged by using modified atmospheres in films that control the permeability of gases. In addition to being sold fresh, fruits are also sold dried and packaged with preservatives. Dried fruits are also used in a variety of products such as confectionary bars, cookies, chocolates, breads, and many cereal based products. Minimally processed fruit can be sold as fruit salads or incorporated into dairy products such as yogurt, cottage cheese, or ice cream.
Fresh-cut vegetables include ready-to-eat washed, sliced, chopped, or shredded vegetables, dry coleslaw mixes (without dressing), and complex mixed salads, as well as stir-fry products. Raw or cooked vegetables (with or without fruit and meat or poultry) are used as ingredients in prepared (deli) salads with mayonnaise or other types of dressings. Due to their highly perishable nature, most fresh fruits and vegetables need temperature control to extend their shelf life. Preservation of fruits and vegetables is achieved by drying, salting, freezing, refrigeration, canning, fermentation, irradiation, and packaging under vacuum or modified atmospheres.
Over the past several years, seeds, either fresh or cooked, have become a commonly consumed produce item. Seed sprouts may harbour very low levels of pathogens (Salmonella serotypes, B. cereus, E. coli O157:H7, and Y. enterocolitica) that can multiply to very high levels during the 3 to 10 d sprouting process and survive through the typical refrigerated shelf life of the products (IFT 2001). Whereas mung bean sprouts are often stir-fried or otherwise heated prior to consumption, which would reduce the risk of disease, other seed sprouts are often consumed raw and have been associated with foodborne illness (IFT 2001). For these products, time/temperature control would not prevent microbial hazards and, therefore, sanitation procedures that would reduce the contamination and growth of pathogens growth should be in
place.

Microbial concerns

The initial bacteria of fresh produce derive from contamination from air, soil, water, insects, animals, workers, and harvesting and transportation equipment. In fruits, bacteria are usually present in low numbers, but contamination by yeasts and molds is more prevalent due to the lower pH of fruits and the lack of competition from other microorganisms (ICMSF 1998, p 253). Microorganisms also found in vegetables include Pseudomonas and Erwinia as well as coryneforms, lactic acid bacteria, spore formers, coliforms, and micrococci. Yeasts and molds are often present but in lower numbers than bacteria. Sufficient moisture, abusive temperature, and adequate time will ensure a continuing increase in the bacterial population on fruits and vegetables, particularly in fresh-cut products.

Pathogens of concern

Since 1973, the number of reported outbreaks of foodborne illness associated with produce has more than doubled. As a result, pathogens on fresh fruits and vegetables have become a major concern. Pathogenic bacteria are not usually associated with fruit, but pathogens can be present due to fecal contamination.
There have been a number of outbreaks of salmonellosis and E. coli O157:H7 infection associated with the consumption of a variety of fruits, including raw tomatoes, sliced watermelons, cantaloupes, and unpasteurized apple and orange juice. Human pathogens have been isolated from more than thirty kinds of vegetables and include Salmonella spp., Shigella spp, Y. enterocolitica, E. coli O157:H7, L. monocytogenes, C. botulinum, and B. cereus. Fresh-cut produce presents a special concern because of the disruption of natural protective barriers that may result in increased pathogen multiplication.

Effects of processing

Fruits and vegetables are frequently consumed raw without being exposed to a process that reliably eliminates pathogens. Washing fruits and vegetables in chlorinated water can reduce bacterial levels but cannot be relied upon to eliminate pathogens. Traditional processing methods such as freezing, canning, dehydration, fermentation, and acidification are used to improve the stability of fruits and vegetables.

Time/temperature control

Outbreaks of salmonellosis and E. coli O157:H7 infection linked with a variety of fruits and vegetables have increased the concerns as to the safety of these foods. Strategies to reduce microbial hazards in produce include the implementation of Good Agricultural Practices on farms, and Good Manufacturing Practices in packing, handling, and storage. Due to their highly perishable nature, most fresh fruits and vegetables need time/temperature control to extend their shelf life. In any case, attention should be paid to storage times and temperatures since pathogens, if present, are able to grow— particularly in the case of fresh-cut produce or where internalization is possible. Storage temperature and time management are important in reducing the risks of foodborne illness, and become critical parameters for any fresh-cut produce. However, as mentioned above, the time/temperature for seed sprouts will not
reduce the risk of presence of high levels of pathogens. While, traditional processing methods such as freezing, canning, dehydration, fermentation, and acidification are used to improve the stability of fruits and vegetables, and time/temperature control may not be a requirement for these processed products.

Cereal grains and related products

Types of products

Cereal grains and related products include baked goods (breads, muffins, cakes, pastries, cookies, biscuits, bagels, and so on), frozen and refrigerated dough, breakfast cereals (cold cereal, oatmeal, grits, and so on), refrigerated or dry pasta and noodles, and cooked grains (for example, rice). Some products, such as baked goods, have a long history of safe storage at room temperature; others, such as rice, require time/temperature control after preparation.

Pathogens of concern

Grains and milled products are raw agricultural commodities; therefore, a variety of microorganisms, including mold, yeast, coliforms and other bacteria, occur naturally. Grains and milled products are dried to inhibit mold growth during storage, a process that easily controls growth of bacterial pathogens.
Therefore, while organisms such as Salmonella spp. may be present, the prevalence and levels are low (usually <1%). Raw ingredients used to prepare dough products (for example, eggs, dairy products, meats) may introduce Salmonella spp., and need to be considered when analyzing potential hazards.
Staphylococcus aureus may present a potential hazard for certain raw dough, such as pasta dough processed at warm temperatures for extended periods of time (days); however, yeast leavened dough and cookie dough control the organism through competitive inhibition and low aW , respectively. Bacillus cereus presents a concern in cooked rice.

Effects of processing

Baking, boiling, steaming, or frying are the methods used to cook the cereal-grain products. The
temperatures required to achieve product quality easily destroy vegetative pathogens that may be present.
These temperatures are needed to properly set the starch structure and/or to rehydrate dry products. Baking and frying not only destroy vegetative pathogens such as S. aureus and Salmonella spp., but they also remove moisture from the product—especially at the exterior surface. This dehydrated surface inhibits the growth of most bacteria; thus, mold is the primary microbial mode of failure for baked goods. When stored at room temperature, baked and fried products typically continue to lose moisture to the atmosphere, further reducing the potential for pathogen growth. Thus, baked and fried cereal-grain products such as cakes, breads, muffins, and biscuits have a long history of safe storage at room temperature despite having an internal aW of approximately 0.94-0.95 (but may be as high as 0.98). While boiled or steamed cereal products achieve temperatures lethal to vegetative pathogens during the cooking process, these products increase in aW to levels that support the growth of many microbial pathogens. Thus, time/temperature control is required to assure the safety of these products. For
example, numerous B.cereus outbreaks have been associated with fried rice prepared using boiled rice that was held for hours at room temperature.

Time/temperature control

Although baked and fried cereal-grain products (for example, cakes, breads, muffins, and biscuits) have a high aW, a number of reasons may justify their shelf-stability: they have a long history of safe storage at ambient temperature; processing temperatures and moisture reduction, especially on the surface, preclude the growth of pathogens; and they are often formulated to include ingredients that enhance product safety and stability so as to permit distribution without temperature control for limited periods of time. Ingredients that are used to enhance safety and stability include humectants to reduce aw (sugars and glycerine), preservatives (calcium propionate, potassium sorbate, sorbic acid), acids to reduce pH (vinegar, citric acid, phosphoric acid, malic acid, fumaric acid), spices with antimicrobial properties (cinnamon, nutmeg, garlic), and water-binding agents to control free water (gums, starches). The primary mode of spoilage of baked goods is mold growth, which is visible and alerts the consumer to avoid consumption, further reducing the risk of illness due to spoiled product. These characteristics plus their long history of safe storage at room temperature would allow these products to be stored at ambient temperature. Boiled or steamed cereal products, such as rice, require time/temperature control after preparation due to the increase in aw. Dough is frequently used to enrobe other food ingredients. Careful consideration must be given to these
combination products to accurately assess the need for time/temperature control. For example, egg and dairy ingredients baked inside a pastry, such as cream-cheese croissant, will receive sufficient heat treatments to destroy vegetative pathogens and may therefore be stable at room temperature with water activities above 0.86. However, if the filling is injected after the baking process, as in the case of a cream-filled éclair, the potential for contamination must be assessed. Meat and vegetable-filled cereal products with high water activities (>0.94) and neutral pH generally require time/temperature control because the baking process can activate spore formers such as C. botulinum that are present in these ingredients.

Fats, oils, and salad dressings

Types of products

Fats and oils are primary components of many foods that are emulsions comprised of oil as the
continuous phase and water as the discontinuous phase. Mayonnaise, salad dressings, and related products are examples where water is the continuous phase and oil (fat) the discontinuous phase. Product types have grown to also include pourable dressings and starch-based dressings that resemble mayonnaise. In addition, in recent years products such as garlic-in-oil, various herb/spices-in-oil, and flavored oils have proliferated.

Microbial/pathogen concerns

The form of the water-in-oil emulsion in mayonnaise and salad dressings, particularly the chemical composition of the water phase, plays a key role in their microbiological stability. The pH range is 3.2 to 4.0 due to acetic acid; the oil content, 65 to 80%; the aqueous phase salt content, 9 to 11%; and the sugar content is 7 to 10%. This composition provides an aw of ~ 0.925. Pourable dressings have a pH in the range of 3.5 to 3.9. Microbial stability is largely related to the maximum preservative effect of acetic acid, mostly undissociated at those low pH levels. Although the aW of mayonnaise and salad dressings is not sufficiently low to preclude growth of S. aureus, at pH 4.1 and below, S. aureus does not survive. Additionally, mayonnaise and salad dressings do not support the growth of C. botulinum because of the low pH and aW. The low aW also precludes the growth of B. cereus. The few documented cases of Salmonella-related foodborne illnesses have been related to deviations in pH and in the proportion of egg
yolk and vinegar. These deviations typically occurred with non-commercially prepared products that lack the proper control of pH and the hold time to allow pathogen die-off.
Oil products that can create anaerobic sites of sufficient aW favorable for C. botulinum growth and toxin production are problematic; for example, the addition of fresh garlic to oil. The moisture surrounding the garlic fragments coupled with no acidulant creates the conditions necessary for C. botulinum growth and toxin production. To maintain a pH that precludes growth and toxin production, an acidulant is required in these products.

Effects of processing

Following Good Manufacturing Practices can protect these products from contamination. Formulating with appropriate levels of acetic acid is essential to protect fats and oils against pathogenic bacteria; salad dressings with a pH less than 4.0 are very safe. Refrigeration after opening is recommended to prevent oxidation of the oils and product separation, but not for safety. A recent review of the microbiological safety of mayonnaise, salad dressings, and other sauces revealed that Salmonella, E. coli O157:H7, L. monocytogenes, S. aureus, and Y. enterocolitica die when inoculated into mayonnaise and dressings (Smittle 2000).

Time/temperature control

Products with formulations that do not meet aW, pH, and acidity requirements as outlined above may require time/temperature control. Addition of flavoring components to traditional oils must be done in conjunction with added acidifying agents. Addition of other ingredients, such as garlic or herbs, would require an assessment or challenge testing before the product is designated shelf-stable.

Eggs and egg products

Types of products

“Eggs,” as a product category, refers to eggs in the shell. “Egg products” refers to eggs that have been separated from their shells to produce liquid, concentrated, dried, crystallized, frozen, coagulated, and reduced cholesterol products (ICMSF 1998, p 495). In the United States, approximately 83 % of the eggs are sold as shell eggs (ICMSF 1998, p 480). Liquid eggs are usually homogenized as whole eggs or separated into white and yolk. Sugar, salt, or acidulants may be added to yolks that will be further processed. All liquid eggs are usually pasteurized and require temperature control at refrigeration or frozen temperatures. Liquid egg products are used as ingredients in a wide variety of processed products including bakery products (meringues, custards, cream, angel food cakes, and egg washes), confectionary products, drinks, special dietary foods, infant products, sauces and dressings, mayonnaise, and noodles (ICMSF 1998, p 480).

Microbial concerns

Eggs can become contaminated through trans-ovarian or trans-shell infection. Freshly laid eggs may be contaminated through the oviduct of an infected hen. The shell of a newly formed egg can become contaminated with a variety of microorganisms from the environment where the egg is laid. Although there are a number of antimicrobial barriers present in eggs (lysozyme, conalbumen, avidin, and alkaline pH), spoilage and pathogenicity are related to the ability of microorganisms to penetrate the shell and overcome these barriers. The bacterial ecology of eggs is varied and consists of psychrotrophic (primarily Pseudomonads) and mesophilic bacteria and can also include some pathogens. Federal regulations stating that shell eggs must be kept refrigerated prior to use have been recently implemented (“Food Labeling, Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution,” 65 FR 76092 [Dec. 5, 2000]). When properly cooked or processed (pasteurized) and stored at appropriate temperatures, the
bacterial loads in these products are greatly reduced. Heat treatments used for liquid eggs do not produce shelf-stable products, so proper temperature control and safe handling after opening or thawing are necessary to prevent post-process or cross contamination and growth of pathogens.

Pathogens of concern

The principal human pathogens of concern in eggs and egg products are of the genus Salmonella
(primarily Salmonella Enteritidis). These pathogens can enter the egg either by trans-ovarian
transmission or by penetrating the surface of the egg in a way similar to that of spoilage organisms. Listeria monocytogenes is also a concern in processed eggs, particularly in products with extended shelf life.

Effects of processing

Shell eggs are usually fried, boiled, or baked. In these cooking methods, it is important that eggs reach appropriate temperature to destroy any salmonellae that may be present. Eggs boiled or cooked long enough to solidify the yolk (~ 10 min of boiling) are heated sufficiently to inactivate salmonellae, but other cooking procedures that leave the yolk in a liquid state (for example, soft boiled and fried eggs “over easy”) are not always sufficient to inactivate Salmonella spp. Liquid eggs, white, and yolk that do not contain chemical additives are usually pasteurized at temperatures that vary from 55.6 °C (132 °F) to 69 °C (156 °F) at processing times that vary from 10 to 1.5 min. Lower temperatures and shorter processing times increase the risk of survival of Salmonella spp., whereas higher temperature and longer processing times increase damage to the functional properties of the egg. It should be noted that reduced aw and longer heating times are required to achieve the same level of pathogen reduction. In the United States, pasteurization requirements are 60 °C (140 °F) for 3.5 min, which achieve more than a 3 log reduction of salmonellae. Proper pasteurization reduces the initial level of other microorganisms; however, if the product is temperature abused, some bacteria, such as micrococci, staphylococci, Bacillus spp., enterococci, and catalase negative bacterial rods, survive the process and can grow.

Time/temperature control

Eggs and egg products will easily support the growth of spoilage and pathogenic microorganisms and clearly require time/temperature control to assure safety. Control methods require an integrated approach that begins at the egg production facility, and carries through to processing and further processing operations as well as to retail and food service facilities. Temperature control of shell eggs, followed by thorough cooking and proper handling, are essential in assuring safety. As mentioned above, heat treatments used for liquid eggs do not produce shelf-stable products, so they should be kept refrigerated or frozen. These products should be safely handled to reduce the likelihood of post-process and/or cross contamination.

Milk and milk products (except cheeses)

Types of products

Milk, the lacteal secretion from warm-blooded animals, is commercially available most commonly from cows, goats, and sheep. Milk may be available to consumers as a single- or multiple-ingredient fluid pasteurized product. It can also be obtained in a concentrated form, such as evaporated or condensed milk, or in a dry form. Bacterial cultures can be used in making other products such as cultured milk, yogurts, and cheeses. Milk and milk products are also included as major ingredients in other food forms ranging from ice cream to prepared foods.

Microbial concerns

Milk is an excellent growth medium for many kinds of microorganisms, as it provides rich nutrients for microbes, is high in moisture, and has neutral pH. Due to these factors, it is subject to microbial spoilage from the moment it is secreted from a healthy animal. Milk is exposed to the potential for microbial contamination during collection, storage, transportation, and processing. Without basic sanitary practices in place and temperature control during handling, the product will quickly spoil and become unacceptable for human consumption. Uncontrolled microbial growth affects the flavor and appearance of the product and can affect its safety. On the other hand, controlled use of microbial cultures can produce many flavorful products and can also preserve milk and milk products. Milk and milk products are normally consumed after the application of a processing step to reduce pathogenic microorganisms.

Pathogens of concern

The principal pathogens of concern associated with milk and processed milk products are Salmonella spp., L. monocytogenes, S. aureus, enterohemorrhagic E. coli, Campylobacter jejuni, C. botulinum, and B. cereus.

Effects of processing

Non-spore forming pathogens are reduced in fluid milk through pasteurization. Milk used as an
ingredient in other products is normally pasteurized or thermally processed in some form to reduce possible pathogens. The exceptions would be some cheese-making processes that rely on microbial cultures and the effects of their growth in the milk medium over time to render the finished food safe. While most milk and milk products are sold refrigerated to prevent spoilage, some dairy products are shelf stable due to a combination of moisture content, salts, and pH that control the growth of microbes. Canned milks are shelf stable due to thermal processing of the product within the individual containers. Some milk and milk products may be aseptically processed and packaged to enable the product to be shelf stable. Other dairy products may be thermally processed and packaged hot in conjunction with product formulations designed to inhibit the growth and survival of pathogenic organisms in products stored at room temperature. Microbial growth in dried milk is prevented by removing most of the moisture in fluid milk. Other dairy products, such as ice cream, are sold in a frozen state to limit the growth of microbes.
Protection from post-pasteurization contamination before the milk product is packaged is a critical factor in achieving a safe food. Multiple-ingredient dairy products may raise the concern of contamination depending on the characteristics of the product and the location where the ingredient may be added in the process. Ingredients added after pasteurization of the milk portion of the food can be a source of pathogens. The control of potential sources of contamination can be addressed by following production practices based upon Good Manufacturing Practices.

Time/temperature control

During handling, basic sanitary practices and temperature control are required to maintain acceptable sensory qualities of milk and milk products. Similarly, most milk and milk products are sold refrigerated to prevent spoilage. Exceptions include canned milks, dried milk, ice cream, asceptically processed and packaged products, and thermally processed products that are packaged hot in conjuntion with specific product formulations. These milk products do not require refrigeration because of the combination of moisture content, salts, and pH that control the growth of microbes.

Defrosting Chicken meat

Thawing, Storing and Freezing Chicken

Frozen chicken is best thawed gradually in the refrigerator, but to speed up the process if you are in a hurry, use the cold water method.

REFRIGERATOR METHOD

Place the chicken , in its plastic wrap, on a tray in the refrigerator. The exact thawing time will depend on the size of the bird and the temperature of the refrigerator, but it can be estimated as follows:

- 1 to 2 pounds =12 hours thawing time
- 2 to 4 pounds = 12 to 24 hours thawing time
- 4 to 6 pounds = 24 to 36 hours thawing time
- 6 to 12 pounds = 1&1/2 to 2 days thawing time
- 12 to 20 pounds = 2 to 3 days thawing time
- 20 to 24 pounds = 3 to 3&1/2 days thawing time

COLD WATER METHOD

Place chicken in its original plastic wrap in a large pan or in the sink and cover with cold water. Change the water regularly as its temperature drops until bird thaws. Small chickens will thaw within 1 hour, 4 - 12 pound birds in 3 to 6 hours.

STORING AND FREEZING COOKED CHICKEN

Cooked chicken should stand at room temperature no more than about 1&1/2 hours after cooking. Store loosely wrapped in the refrigerator and use within 2 or 3 days. Store stuffings and gravy seperately in covered containers. Gravy should be reheated to boiling and poured into a warmed gravy boat just before serving.

Before freezing cooked chicken, cool and separate the meat, stuffing and gravy. Freezer-wrapped cooked chicken will retain its quality for about 2 months. stuffing and gravy should always be used within 1 month of freezing.

http://www.angelfire.com/ak4/chicken/intro2.html

Temperature in doubt

Food Safety Checklist For"Planned-over" Foods

Food can be handled SAFELY. In order to assure the BEST TASTE, the follow tips is useful to keep the leftovers into promising planned-overs.

Cooling

Separate and refrigerate the portion to be served for your next meal BEFORE you put the food on the table. This keeps food quality higher by preventing "planned-overs" from becoming "picked-overs." It also helps keep food safe.

Refrigerate planned-overs in shallow containers so they cool faster in the refrigerator. It's not necessary for a food to be completely cool before it's refrigerated. To help food cool slightly before refrigeration, place a shallow container of food on a cooling rack to allow air to circulate all around the pan for about 20 to 30 minutes.

For thicker foods, such as stews, hot puddings and layers of meat slices, limit depth of food to 2 inches. LOOSELY cover food upon refrigeration. This allows heat to escape and protects from accidental contamination from other foods during cooling. Stir food occasionally to help it cool; use a clean utensil each time. Cover tightly when cooled.

Avoid letting perishable cooked foods, such as meat, poultry, fish, eggs, dairy products, cooked rice and pasta sit at room temperature longer than 2 hours TOTAL -- the TOTAL is the total of the first and second use.

A refrigerator temperature of 40 F (Appx 4 degree cel) or lower will slow bacterial growth. Keep your freezer at 0 F or lower. Freezing will stop most bacterial growth so frozen foods keep longer than those at refrigerator temperature. Freezing DOES NOT kill bacteria -- it is still important to handle food safely.

Keep an appliance thermometer in your refrigerator and in your freezer to assure they stay at these recommended temperatures. Buy a thermometer at a discount, hardware, grocery store or other store that sells kitchen cooking tools.

Periodically, place an instant-read thermometer in your refrigerator and in your freezer to check the accuracy of your appliance thermometer. Replace an inaccurate appliance thermometer if it cannot be calibrated.

As a general rule, use the refrigerated planned-overs within one to two days for best safety and quality. Freeze for longer storage. Cool foods in the refrigerator before putting them in your freezer.

General Freezing Tips

Freeze foods in portion sizes you'll need for future meals. For example, if there are two in your family and you each eat a cup of rice for a meal, freeze in two-cup portions.
Some common foods generally cited as NOT freezing well include:
Cooked eggs.
Cooked "chunks" of potatoes (mashed and twice-baked may freeze satisfactorily).
Custards and cream puddings, by themselves or in pies.
Potato salad.
Pasta.
Raw, watery vegetables such as lettuce, cucumbers and radishes; tomatoes, celery and cabbage might be satisfactory frozen as an ingredient in an already cooked dish such as a soup or casserole.
Yogurt and sour cream.
Mayonnaise may separate during freezing and thawing.
Sauces and gravies thickened with flour or cornstarch may separate and break down when frozen.
Fried foods may lose their crispness.
Crumb toppings, such as on casseroles, may become soggy after freezing.
Sometimes you will see these foods in commercially frozen versions of some of these items because food companies have equipment that freezes food faster and helps retain quality better.

Also, various ingredients, generally unavailable to home cooks, are used commercially to help prevent frozen foods from breaking down.
Before you double a recipe for frozen "planned-overs," experiment by freezing a small amount the next time you make the recipe. If you're satisfied with the results, prepare extra food for freezing when you make the recipe again.

As a general rule, foods with a high water content, such as the vegetables in our list, do not freeze well. The water in food expands during freezing and breaks down the food's structure, making the food mushy when thawed. This is why frozen fruit packages often advise eating the fruit while still slightly frozen.

To hasten thawing when freezing foods: freeze in a thinner, flattened shape in freezer bags or freezer foil. A rounded shape takes longer to thaw through to the middle. Flatter packages also will stack better in your freezer. Remember to cool foods to refrigerator temperature before putting them in your freezer.

Pack foods fairly tightly into containers or press out excess air when packing food in bags. For most foods, it's helpful to leave a little space (about 1/2 inch) between the food and the freezer package closure to allow for expansion of the food as it freezes.
While frozen food remains safe indefinitely at 0 F, the quality deteriorates the longer it's stored.

Check storage times of specific foods using the Food Marketing Institute's (FMI) "Food Keeper" at www.fmi.org/consumer/foodkeeper/search.htm OR read FMI's entire brochure at www.fmi.org/consumer/foodkeeper/brochure.cfm

"Freezer burn," when the surface of the food appears light-colored and dried out, occurs when moisture on the surface evaporates. Proper cooling, air removal, moisture-vapor-resistant packaging, a tight seal and an appropriate length of storage help prevent freezer burn. While a food with freezer burn is safe to eat, the quality is lower.

Label each package with the type and amount of contents and the date it was frozen. Use the dates to assure products are eaten while the quality is still good.
If you're freezing several packages at once, leave a little space between them so air can circulate freely and they freeze faster. Move them closer together when they're frozen.

Packaging Food for the Freezer
Freezing Wrapping Materials

Suitable freezer wrapping materials include freezer paper, plastic freezer bags and freezer aluminum foil.
Check wrapping labels for specific information about whether the wrappings work for freezing. For example, not all plastic bags are designed for freezer use. It's important to use materials intended for freezing as they're more likely to keep moisture out and less likely to tear in the freezer.

For freezer paper, check directions for which side of the paper is placed next to the food. Unless directed otherwise, the plastic-coated side goes next to food. Secure freezer paper with freezer tape.

Freezer Containers

Rigid freezer containers include metal, foil, plastic, glass and ceramic containers identified by the manufacturer as suitable for freezing. CAUTION: Carefully read manufacturer's directions about safe handling when using glass or ceramic dishes labeled freezer/microwave/oven safe.
Foil and metal pans work well for freezing foods you'll re-heat in the oven. Cover pan tightly with freezer-quality foil or place in a plastic freezer bag. Metal/foil pans cool quicker and heat faster than ceramic or glass containers.

Freezer/microwave safe-containers are a good choice for foods you'll reheat in the microwave.
Choose a container that fits the amount of food you're freezing.
Some containers aren't suitable for freezing. For example, milk and cottage cheese cartons aren't moisture-vapor-resistant enough for freezing.

Safe Thawing

DO NOT thaw perishable foods at room temperature. Just ONE bacterium, doubling every 20 minutes, could grow to 64 bacteria in two hours and 2,097,152 bacteria in seven hours!
If perishable foods, such as meat, are left at room temperature too long, bacteria may grow and produce heat-resistant toxins that can cause food-borne illness. Cooking may not be able to destroy these toxins.

It's best to plan ahead for slow, safe thawing in the refrigerator. Small items may thaw overnight in the refrigerator. Larger foods may take longer -- allow approximately one day for each 5 pounds of weight. Thaw packages of raw meat, poultry or fish on plates on lower shelves of refrigerators to prevent their juices from dripping on other foods.

For faster thawing, place food in a leakproof plastic bag and immerse bag in COLD water. Change the water every 30 minutes to assure it stays cold. DO NOT use hot water. After thawing, refrigerate the food until ready to use. Food thaws in cold water at the rate of approximately a pound per half hour.
If food is thawed in the microwave, cook it right away. Unlike food thawed in a refrigerator, microwave-thawed foods reach temperatures that encourage bacterial growth. Cook immediately to kill any bacteria that may have developed and to prevent further bacterial growth.

If thawing in a plastic freezer bag in the microwave, follow manufacturer's directions for such things as venting, recommended heat settings, types of foods suitable for microwave-thawing, etc. for that specific bag.

Follow microwave manufacturer's directions for your specific microwave.

Serving Planned-overs

When reheating planned-overs, heat until steamy hot throughout (165 F).

http://lancaster.unl.edu/food/ciqplannedovers.htm

HACCP & Recall procedures....

Some readings

HACCP:

1. http://rbkc.gov.uk/EnvironmentalServices/foodhygieneandstandards/business10.asp#whatdoes
2. http://www1.agric.gov.ab.ca/$department/deptdocs.nsf/all/afs4338

Product Recall:

1. http://www.iccc.gov.pg/publications/PRODUCT%20RECALL%20GUIDE%20UC2.pdf (Simplified)
2. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/recall_proc-marche_retrait_e.pdf (Impt)