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Public Health Reasons / Administrative Guidelines for:

Chapter 3 Food


3-101.11 Safe, Unadulterated, and Honestly Presented.


3-201.11 Compliance with Food Law.

Refer to the public health reason for § 3-401.11.

A primary line of defense in ensuring that food meets the requirements of § 3-101.11 is to obtain food from approved sources, the implications of which are discussed below. However, it is also critical to monitor food products to ensure that, after harvesting and processing, they do not fall victim to conditions that endanger their safety, make them adulterated, or compromise their honest presentation. The regulatory community, industry, and consumers should exercise vigilance in controlling the conditions to which foods are subjected and be alert to signs of abuse. FDA considers food in hermetically sealed containers that are swelled or leaking to be adulterated and actionable under the Federal Food, Drug, and Cosmetic Act. Depending on the circumstances, rusted and pitted or dented cans may also present a serious potential hazard.

Food, at all stages of production, is susceptible to contamination. The source of food is important because pathogenic microorganisms may be present in the breeding stock of farm animals, in feeds, in the farm environment, in waters used for raising and freezing aquatic foods, and in soils and fertilizers in which plant crops are grown. Chemical contaminants that may be present in field soils, fertilizers, irrigation water, and fishing waters can be incorporated into food plants and animals.

Sources of molluscan shellfish are a particular concern because shellfish are frequently consumed raw or in an undercooked state and thus receive neither heat treatment nor any other process that would destroy or inactivate microbial pathogens. For safety, these foods must be accompanied by certification that documents that they have been harvested from waters that meet the water quality standards contained in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish. Certification also provides confidence that processing, packaging, and shipping have been conducted under sanitary conditions.

Food should be purchased from commercial supplies under regulatory control. Home kitchens, with their varieties of food and open entry to humans and pet animals, are frequently implicated in the microbial contamination of food. Because commercial items seldom are eaten right away, the home kitchen's limited capacity for maintaining food at proper temperatures may result in considerable microbial growth and toxin production by microorganisms introduced through the diverse sources of contamination. Controlled processing is required for the safe preparation of food entering commerce.

Labeling - General

Sources of packaged food must be labeled in accordance with law. Proper labeling of foods allows consumers to make informed decisions about what they eat. Many consumers, as a result of an existing medical condition, may be sensitive to specific foods or food ingredients. This sensitivity may result in dangerous medical consequences should certain foods or ingredients be unknowingly consumed. In addition, consumers have a basic right to be protected from misbranding and fraud.

Except for certain species of large tuna and raw molluscan shellfish, if fish are intended for raw consumption, they must be properly frozen before they are served. If this process is done off-premises, purchase specifications ensuring that proper freezing techniques are used to destroy parasites must be provided. Labeling should accompany the product to advise as to whether the product was frozen properly. This is necessary because fish from natural bodies of water may carry parasitic worms that can infect and injure consumers who eat such raw fish dishes as sushi, ceviche, green (lightly marinated) herring, and cold-smoked salmon. The worms are often deeply imbedded inside fish muscle. Thorough freezing kills these worms if the fish are subjected to a low enough temperature for a long enough time.

Labeling for Fish

Except for raw molluscan shellfish, certain species of large tuna, certain aquacultured fish. and fish eggs that have been removed from the skein and rinsed, if fish are intended for raw or undercooked consumption, they must be properly frozen before they are served. If this process is done off-premises, purchase specifications ensuring that proper freezing techniques are used to destroy parasites must be provided. Labeling or other information should accompany the product to advise as to whether the product was frozen properly. This is necessary because fish from natural bodies of water may carry parasitic worms that can infect and injure consumers who eat such raw fish dishes as sushi, ceviche, green (lightly marinated) herring, and cold-smoked salmon. The worms are often deeply imbedded inside fish muscle. Thorough freezing kills these worms if the fish are subjected to a low enough temperature for a long enough time.

Labeling for Juice

On July 8, 1998, FDA announced in the Federal Register a final rule that revised its food labeling regulations to require a warning statement on fruit and vegetable juice products that have not been processed to prevent, reduce, or eliminate pathogenic microorganisms that may be present. FDA took this action to inform consumers, particularly those at greatest risk, of the hazard posed by such juice products. FDA expects that providing this information to consumers will allow them to make informed decisions on whether to purchase and consume such juice products, thereby reducing the incidence of foodborne illnesses and deaths caused by the consumption of these juices.

On July 18, 2001 FDA announced a final rule designed to improve the safety of fruit and vegetable juice and juice products. Under the rule, juice processors must use Hazard Analysis and Critical Control Point (HACCP) principles for juice processing. Processors making shelf-stable juices or concentrates that use a single thermal processing step are exempt from the microbial hazard requirements of the HACCP regulation. Retail establishments where packaged juice is made and only sold directly to consumers (such as juice bars) are not required to comply with this regulation.

Rather, the Food Code requires fresh fruit or vegetable juices that are packaged at retail (untreated juices or beverages containing untreated juices that are offered to consumers as prepackaged foods) to be processed under HACCP with a 5 log reduction in pathogens of concern OR bear the warning statement as specified in 21 CFR Section 101.17(g). That statement is: "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems." Refer to Chapter 1 for the definition of juice. It is important to note that the definition of "juice" includes puréed fruits and vegetables, which are commonly prepared for service to highly susceptible populations.

Food establishments that serve a highly susceptible population (HSP) cannot serve prepackaged juice that bears the warning label and they must serve only pasteurized juice. For juice only, this population includes children who are age 9 or less and receive food in a school, day care setting, or similar facility that provides custodial care.

Unpackaged juice (glasses of juice prepared at a juice bar, for example) does not require the 5 log reduction nor a warning statement or other consumer advisory (juice is not an animal food and therefore not covered by section 3-603.11) when prepared and served at retail. Usually the juice is served by the glass or in small batches compared to a commercial juice processor. The risk of using "drops" and damaged fruits or vegetables is much less at retail because of buyer specs that provide higher quality produce, meaning that fruits for juicing are less likely to be of a lower quality or damaged.

Labeling for Meat and Poultry

Retail food establishments that process and package meat or poultry in a form that is not ready-to-eat, are obligated by Federal regulation to label the product with safe food handling instructions. The intent of this requirement is to ensure that all consumers are alerted to the fact that such products may contain bacteria and that food safety hinges upon their thoroughly cooking the product, regardless of where they obtain the products. That is, the labeling would exist if they obtain their meat and poultry at an establishment that handles only prepackaged and prelabeled products or if they obtain their meat or poultry at an operation such as a supermarket with a meat processing operation or from a small neighborhood butcher.

Labeling Guidance for Irradiated Raw Meat and Meat Products

In December 1999, the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) issued a final regulation to permit the use of ionizing radiation to reduce foodborne pathogens, including Escherichia coli O 157:H7, and extend the shelf life of raw refrigerated and frozen meat and meat products (Irradiation of Meat Food Products 64 Federal Register 72150, December 23, 1999).

The final regulations are published in Title 9 of the Code of Federal Regulations (9 CFR 424.21 Use of food ingredients and sources of radiation and provide that raw refrigerated products may receive a maximum absorbed dose of no more than 4.5 kGy, and that frozen product receive no more than 7.0 kGy, in accordance with the FDA restrictions provided for in Title 21 of the Code of Federal Regulations (21 CFR 179.26(a) Ionizing radiation for the treatment of food, (a) Energy sources). The regulations further require that all irradiated meat and meat products bear labeling that reflects that the product was irradiated, or that the product contains an irradiated meat or poultry product. This labeling requirement is applicable even at retail facilities where irradiated coarse ground beef might be finely ground for retail sale, or in cases where irradiated product is combined with other non-irradiated meat or poultry product for retail sale.

In cases where the entire package of product is irradiated, the labeling must include both a statement and the international symbol, called the radura. Additionally, the product name must include the word "irradiated," or the labeling must bear a disclosure statement such as, "treated with radiation" or "treated by irradiation." If either statement is used, the logo must be placed in conjunction with the statement. If an irradiated meat or meat product is used to formulate a multi-ingredient product with other non-irradiated components, the irradiated meat ingredient must be identified as such in the ingredients statement, but the logo is not required. For example, the ingredients statement for a Chicken and Beef Sausage product that contains irradiated beef would be, Ingredients: chicken, irradiated beef, seasonings (salt, pepper, spice), and the logo would not be required to be present.

All labels for products produced at federally inspected establishments bearing statements about irradiation must be submitted to USDA/FSIS for evaluation and approval prior to use.

Optional labeling statements about the purpose of the irradiation process may be included on the labeling of irradiated products provided they are not false or misleading and have been evaluated first by USDA/FSIS. If such statements indicate a specific benefit from irradiation, such as a reduction of microbial pathogens, such statements must be substantiated by processing documentation and validated through the processing and Hazard Analysis and Critical Control Point (HACCP) system. Such validation and documentation of the HACCP system would only be applicable in federally inspected establishments.

Because irradiation can substantially reduce and, in some situations, eliminate any detectable level of pathogenic bacteria, it is important that the meat products be held at the proper refrigerated temperatures to prevent growth of any pathogens present, and that the packaging is not compromised. Although co-mingling irradiated beef with non-irradiated meat or poultry is not prohibited under the current regulations, USDA/FSIS believes that such a process would decrease the benefit of irradiation by potentially exposing the irradiated product to pathogenic bacteria. While FSIS considers such comingling to be highly unlikely, if it did occur, a statement advising the consumer that the product contains both irradiated and non-irradiated components would be required.

The Radura, International Symbol:

Further information about labeling irradiated raw meat is available through Directive 7700.1, Irradiation of Meat and Poultry Products. on the USDA/FSIS website. Irradiation Questions & Answers (available in PDF (122 KB) ).

Labeling for Raw Shell Eggs

The Code of Federal Regulations 21 CFR 101.17 Food Labeling warning, notice, and safe handling statements. paragraph (h) Shell eggs state in subparagraph (1), "The label of all shell eggs, whether in intrastate or interstate commerce, shall bear the following statement: 'SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria; keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly.'" Further, in subparagraph (4) it states, "Shell eggs that have been, before distribution to consumers, specifically processed to destroy all viable Salmonella shall be exempt from the requirements of paragraph (h) of this section."

Labeling for Whole-muscle, Intact Beef Steaks

In order for a food establishment operator to know that a steak is a whole-muscle, intact cut of beef that can therefore be undercooked and served without a consumer advisory, the incoming product must be labeled. Processors can accommodate this need at the retail level by developing proposed labels, obtaining the necessary USDA Food Safety Inspection Service review and approval, and appropriately affixing the labels to their products.

Refer also to public health reason for § 3-602.11.

3-201.12 Food in a Hermetically Sealed Container.

Processing food at the proper high temperature for the appropriate time is essential to kill bacterial spores that, under certain conditions in an airtight container, begin to grow and produce toxin. Of special concern is the lethal toxin of Clostridium botulinum . an organism whose spores (i.e. survival stages for non-growth conditions) are found throughout the environment. Even slight underprocessing of low acid food which is canned can be dangerous, because spoilage microbes are killed and there are no signs to warn consumers that botulinum spores have germinated into vegetative cells and produced their toxin. If these foods are not processed to be commercially sterile, they must be received frozen or under proper refrigeration.

Refer also to the public health reason for §§ 3-101.11 and 3-201.11.

3-201.13 Fluid Milk and Milk Products.

Milk, which is a staple for infants and very young children with incomplete immunity to infectious diseases, is susceptible to contamination with a variety of microbial pathogens such as Shiga toxin-producing Escherichia coli . Salmonella spp. and Listeria monocytogenes . and provides a rich medium for their growth. This is also true of milk products. Pasteurization is required to eliminate pathogen contamination in milk and products derived from milk. Dairy products are normally perishable and must be received under proper refrigeration conditions.

3-201.14 Fish.

After December 18, 1997, all processors of fish are required by 21 CFR 123 to have conducted a hazard analysis of their operation, identify each hazard that is reasonably likely to occur, and implement a HACCP plan to control each identified hazard. Retailers should assure that their seafood suppliers have complied with this requirement. Hazards known to be associated with specific fish species are discussed in the FDA Fish and Fishery Products Hazards and Controls Guide, available from the FDA Office of Seafood. Species-related hazards include pathogens, parasites, natural toxins, histamine, chemicals, and drugs.

The seafood implicated in histamine poisoning are the scombroid toxin-forming species, defined in 21 CFR 123.3(m) as meaning bluefish, mahi-mahi, tuna, and other species, whether or not in the family Scombridae. in which significant levels of histamine may be produced in the fish flesh by decarboxylation of free histidine as a result of exposure of the fish after capture to temperatures that allow the growth of mesophilic bacteria.

Ciguatera toxin is carried to humans by contaminated fin fish from the extreme southeastern U.S. Hawaii, and subtropical and tropical areas worldwide. In the south Florida, Bahamian, and Caribbean regions, barracuda, amberjack, horse-eye jack, black jack, other large species of jack, king mackerel, large groupers, and snappers are particularly likely to contain ciguatoxin. Many other species of large predatory fishes may be suspect. In Hawaii and throughout the central Pacific, barracuda, amberjack, and snapper are frequently ciguatoxic, and many other species both large and small are suspect. Mackerel and barracuda are frequently ciguatoxic from mid to northeastern Australian waters.


Recreationally caught fish received for sale or service may be approved by the regulatory authority. T he EPA recognizes that fish are a healthy part of our diet and recognizes fishing as an all-American recreational pastime, however, they add the cautionary note that some individuals, such as pregnant women and small children, may need to limit their intake of certain noncommercial fish. Recreationally caught fish may contain possible contaminants that may pose health risks. Fish advisories can be found in EPA Listing of Fish Advisories the EPA website.

States issue fish consumption advisories if elevated concentrations of chemicals such as mercury or dioxin are found in local fish. For most people, the risk from mercury by eating fish is not a health concern. Yet, some fish and shellfish contain higher levels of mercury that may harm an unborn baby or young child's developing nervous system. Therefore, the FDA and the EPA recently advised women who may become pregnant, pregnant women, nursing mothers, and young children to avoid some types of fish and eat fish and shellfish that are lower in mercury. (What You Need to Know about Mercury in Fish and Shellfish ).

State-issued advisories apply primarily to non-commercial fish obtained through sport, recreation, and subsistence activities. Each advisory is different; it may recommend unrestricted, limited, or totally restricted consumption; may be targeted to everyone or limited to women, children, or other people at risk; and may apply to certain species or sizes of fish or a specific waterbody.

States may issue safe-eating guidelines in addition to issuing fish advisories. A fish advisory is issued to warn the public of the potential human health risks from chemical contamination of certain species from particular types of waterbodies such as lakes, rivers, and/ or coastal waters within the State. In contrast, a safe-eating guideline is issued to inform the public that fish from specific waterbodies have been tested for chemical contaminants and the fish from these waters are safe to eat without consumption restrictions.

Regulatory authorities are encouraged to monitor and review the National Listing of Fish Advisories (See August 2004 EPA Fact Sheet as well as the local listings, as part of the decision-making process regarding the approval of recreationally caught fish being used in food establishments.

3-201.15 Molluscan Shellfish.

Pathogens found in waters from which molluscan shellfish are harvested can cause disease in consumers. Molluscan shellfish include: 1) oysters; 2) clams; 3) mussels; and, 4) scallops, except where the final product is the shucked adductor muscle only. The pathogens of

concern include both bacteria and viruses.

Pathogens from the harvest area are of particular concern in molluscan shellfish because: 1) environments in which molluscan shellfish grow are commonly subject to contamination from sewage, which may contain pathogens, and to naturally occurring bacteria, which may also be pathogens; 2) molluscan shellfish filter and concentrate pathogens that may be present in surrounding waters; and, 3) molluscan shellfish are often consumed whole, either raw or partially cooked.

To minimize the risk of molluscan shellfish containing pathogens of sewage origin, State and foreign government agencies, called Shellfish Control Authorities, classify waters in which molluscan shellfish are found, based, in part, on an assessment of water quality. As a result of these classifications, molluscan shellfish harvesting is allowed from some waters, not from others, and only at certain times or under certain restrictions from others. Shellfish Control Authorities then exercise control over the molluscan shellfish harvesters to ensure that harvesting takes place only when and where it has been allowed.

Significant elements of Shellfish Control Authorities' efforts to control the harvesting of molluscan shellfish include: 1) a requirement that containers of in-shell molluscan shellfish (shellstock) bear a tag that identifies the type and quantity of shellfish, harvester, harvest location, and date of harvest; and, 2) a requirement that molluscan shellfish harvesters be licensed; 3) a requirement that processors that shuck molluscan shellfish or ship, reship, or repack the shucked product be certified; and, 4) a requirement that containers of shucked molluscan shellfish bear a label with the name, address, and certification number of the shucker-packer or repacker.

Pathogens, such as Vibrio vulnificus . Vibrio parahaemolyticus . Vibrio cholerae . and Listeria monocytogenes that may be present in low numbers at the time that molluscan shellfish are harvested, may increase to more hazardous levels if they are exposed to time/temperature abuse. To minimize the risk of pathogen growth, Shellfish Control Authorities place limits on the time between harvest and refrigeration. The length of time is dependant upon either the month of the year or the average monthly maximum air temperature (AMMAT) at the time of harvest, which is determined by the Shellfish Control Authority.

Paralytic shellfish poisoning (PSP) results from shellfish feeding upon toxic microorganisms such as dinoflagellates. In the U.S. PSP is generally associated with the consumption of molluscan shellfish from the northeast and northwest coastal regions of the U.S. PSP in other parts of the world has been associated with molluscan shellfish from environments ranging from tropical to temperate waters. In addition, in the U.S. PSP toxin has recently been reported from the viscera of mackerel, lobster, dungeness crabs, tanner crabs, and red rock crabs.

Neurotoxic shellfish poisoning (NSP) in the U.S. is generally associated with the consumption of molluscan shellfish harvested along the coast of the Gulf of Mexico, and, sporadically, along the southern Atlantic coast. There has been a significant occurrence of toxins similar to NSP in New Zealand, and some suggestions of occurrence elsewhere.

For diarrhetic shellfish poisoning there has been no documented occurrence to date in the U.S. However, instances have been documented in Japan, southeast Asia, Scandinavia, western Europe, Chile, New Zealand, and eastern Canada.

Amnesic shellfish poisoning (ASP) is generally associated with the consumption of molluscan shellfish from the northeast and northwest coasts of North America. It has not yet been a problem in the Gulf of Mexico, although the algae that produce the toxin have been found there. ASP toxin has recently been identified as a problem in the viscera of dungeness crab, tanner crab, red rock crab, and anchovies along the west coast of the United States.

Marine toxins are not ordinarily a problem in scallops if only the adductor muscle is consumed. However, products such as roe-on scallops and whole scallops do present a potential hazard for natural toxins.

To reduce the risk of illness associated with raw shellfish consumption, the Food and Drug Administration (FDA) administers the National Shellfish Sanitation Program (NSSP). The NSSP is a tripartite, cooperative action plan involving Federal and State public health officials and the shellfish industry. Those groups work together to improve shellfish safety. States regularly monitor waters to ensure that they are safe before harvesting is permitted. FDA routinely audits the States' classification of shellfish harvesting areas to verify that none pose a threat to public health. Patrolling of closed shellfishing waters minimizes the threat of illegal harvesting or "bootlegging" from closed waters. Bootlegging is a criminal activity and a major factor in shellfish-borne illnesses. Purchases from certified dealers that adhere to NSSP controls is essential to keep risks to a minimum.

3-201.16 Wild Mushrooms.

Over 5000 species of fleshy mushrooms grow naturally in North America. The vast majority have never been tested for toxicity. It is known that about 15 species are deadly and another 60 are toxic to humans whether they are consumed raw or cooked. An additional 36 species are suspected of being poisonous, whether raw or cooked. At least 40 other species are poisonous if eaten raw, but are safe after proper cooking.

Some wild mushrooms that are extremely poisonous may be difficult to distinguish from edible species. In most parts of the country there is at least one organization that include individuals who can provide assistance with both identification and program design. Governmental agencies, universities, and mycological societies are examples of such groups. If a food establishment chooses to sell wild mushrooms, management must recognize and address the need for a sound identification program for providing safe wild mushrooms.

Regulatory authorities have expressed their difficulty in determining what constitutes a "wild mushroom identification expert" and enforcing the Food Code provisions associated with it. In 1998, the Conference for Food Protection (CFP) attempted to alleviate this problem through the formation of a committee that was charged with determining what constitutes a wild mushroom expert. However, the committee was unable to provide this information in a practical, useful manner for State and local regulators within the constraints of the Food Code. The 2000 CFP recommended and FDA accepted the committee's alternative solution that a brochure be developed that will provide information on what constitutes a wild mushroom expert, and to replace "identification by a wild mushroom expert" with "written buyer specifications."

The CFP's recommendation attempts to provide the necessary information in a practical, useful manner for all stakeholders, and yet still convey the highest level of public health protection. The CFP committee suggested that written buyer specifications place more responsibility on the food establishment to ensure that wild mushrooms are obtained from a safe source, and also provides State and local regulators a template to use in ensuring wild mushrooms sold at retail are obtained from a safe source.

However, the recommendation for written buyer specifications will not replace Food Code paragraph 3-201.16(A) until the brochure is developed and accepted by the CFP and FDA. In the interim, the following guidance is provided regarding the identification of wild mushrooms:

A food establishment that sells or serves mushroom species picked in the wild shall have a written buyer specification that requires identification of:

  1. (1) The Latin binomial name, the author of the name, and the common name of the mushroom species,
  2. (2) That the mushroom was identified while in the fresh state,
  3. (3) The name of the person who identified the mushroom,
  4. (4) A statement as to the qualifications and training of the identifier, specifically related to mushroom identification.

Additional information can be found on the California Poison Control web site.

Refer also to the public health reason for §§ 3-101.11 and 3-201.11.

3-201.17 Game Animals.

The primary concern regarding game animals relates to animals obtained in the wild. Wild game animals may be available as a source of food only if a regulatory inspection program is in place to ensure that wild animal products are safe. This is important because wild animals may be carriers of viruses, rickettsiae, bacteria, or parasites that cause illness (zoonoses) in humans. Some of these diseases can be severe in the human host. In addition to the risk posed to consumers of game that is not subject to an inspection program, there is risk to those who harvest and prepare wild game because they may contract infectious diseases such as rabies or tularemia.

Specifications for Receiving

3-202.11 Temperature.

Temperature is one of the prime factors that controls the growth of bacteria in food. Many, though not all, types of pathogens and spoilage bacteria are prevented from multiplying to microbiologically significant levels in properly refrigerated foods that are not out of date. USDA published a final rule (63 FR 45663, August 27, 1998 Shell Eggs; Refrigeration and Labeling Requirements) to require that shell eggs packed for consumer use be stored and transported at an ambient temperature not to exceed 7.2°C (45°F).

High temperatures for a long enough time, such as those associated with thorough cooking, kill or inactivate many types of microorganisms. However, cooking does not always destroy the toxins produced in foods by certain bacteria (such as the enterotoxins of Staphylococcus aureus ). Cooking or hot holding that follows temperature abuse may not make the food safe. Keeping cooked foods hot as required in the Code prevents significant regrowth of heat-injured microorganisms and prevents recontamination with bacteria that are newly introduced.

3-202.12 Additives.

It is imperative for safety that food supplies come from sources that are in compliance with laws regarding chemical additives and contaminants.

Food additives are substances which, by their intended use, become components of food, either directly or indirectly. They must be strictly regulated. In excessive amounts or as a result of unapproved application, additives may be harmful to the consumer. Unintentional contaminants or residues also find their way into the food supply. The tolerances or safe limits designated for these chemicals are determined by risk assessment evaluations based on toxicity studies and consumption estimates.

Food and Color additives must be used in compliance with a federal food, or color additive regulation, an effective food-contact notification, or a threshold of regulation exemption. Such regulations, notifications, and exemptions are generally composed of three parts: the identity of the substance, specifications including purity or physical properties, and limitations on the conditions of use. In order for a food, or color additive use to be in compliance, the use must comply with all three criteria.

Federal Food Additive regulations are found in Title 21 CFR, Parts 172-180. Color additive regulations are found in Title 21 CFR Parts 73-Subpart A, 74-Subpart A, 81 and 82. Effective food-contact notifications are listed at Inventory of Effective Food Contact Substance (FCS) Notifications. and threshold of regulation exemptions are listed at Threshold of Regulation Exemptions .

Other substances that are added to food include those prior sanctioned for use in food by either the FDA or USDA, or those generally recognized as safe for their intended use in food. Some of these are listed in Title 21 CFR Parts 181-186, Title 9 CFR Section 424.21(b) and at GRAS Notice Inventory. Tolerances and exemptions from tolerance for pesticide chemical residues in or on food are found in Title 40 CFR Part 180. Substances that are prohibited form use in human food are listed in Title 21 CFR Part 189.

3-202.13 Eggs.

Damaged shells permit the entry of surface bacteria to the inside of eggs. Eggs are an especially good growth medium for many types of bacteria. Damaged eggs must not be used as food.

The Definition of "Restricted Egg" contains several terms that are explained in this paragraph. An egg may be restricted because it is a/an:

  1. (i) "Check" meaning an egg that has a broken shell or crack in the shell but has its shell membranes intact and contents not leaking.
  2. (ii) "Dirty egg or Dirties" meaning an egg that has a shell that is unbroken and has adhering dirt, foreign material, or prominent stains.
  3. (iii) "Incubator reject" meaning an egg that has been subjected to incubation and has been removed from incubation during the hatching operations as infertile or otherwise unhatchable.
  4. (iv) "Inedible" meaning eggs of the following descriptions: Black rots, yellow rots, white rots, mixed rots, sour eggs, eggs with green whites, eggs with stuck yolks, moldy eggs, musty eggs, eggs showing blood rings, and eggs containing embryo chicks (at or beyond the blood ring stage).
  5. (v) "Leaker" meaning an egg that has a crack or break in the shell and shell membranes to the extent that the egg contents are exposed or are exuding or free to exude through the shell.
  6. vi) "Loss" meaning an egg that is unfit for human food because it is smashed or broken so that its contents are leaking; or overheated, frozen, or contaminated; or an incubator reject; or because it contains a bloody white, large meat spots, a large quantity of blood, or other foreign material.

On December 5, 2000 Federal regulations were amended to require that shell egg cartons bear safe handling instructions and be placed under refrigeration at 45°F or lower upon delivery at retail establishments (65 FR 76091, December 5, 2000, Food Labeling, Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution). The amended provisions include:

  • 21 CFR Part 16 Regulatory Hearing before the Food and Drug Administration, § 16.5 Inappplicability and limited applicability, (4) A hearing on an order for re-labeling, diversion or destruction of shell eggs…
  • 21 CFR Part 101 Food Labeling § 101.17 Food labeling warning, notice, and safe handling statements, (h) Shell eggs .
  • 21 CFR Part 115 Shell Eggs, § 115.50 Refrigeration of shell eggs held for retail distribution.

The labeling rule became effective September 4, 2001, and the refrigeration rule became effective June 4, 2001. These rules are one part of a larger farm-to-table approach for ensuring the safety of our nation's egg supply. The public health goal is a 50 percent reduction in all salmonellosis and a 50 percent reduction in Salmonellae Enteritidis illnesses by 2010.

3-202.14 Eggs and Milk Products, Pasteurized.

Liquid egg, fluid milk, and milk products are especially good growth media for many types of bacteria and must be pasteurized. Pasteurization is a heat process that will kill or inactivate bacteria and other harmful microorganisms likely to be in these potentially hazardous foods (time/temperature control for safety foods). Freezing and drying of unpasteurized products will stop microbial growth and may reduce their bacterial populations; however, some organisms will survive because neither process invariably kills bacteria. Under certain conditions, freezing and drying may preserve microbes. An alternative to pasteurization may be applicable to certain cheese varieties cured or aged for a specified amount of time prior to marketing for consumption.

3-202.15 Package Integrity.

Damaged or incorrectly applied packaging may allow the entry of bacteria or other contaminants into the contained food. If the integrity of the packaging has been compromised, contaminants such as Clostridium botulinum may find their way into the food. In anaerobic conditions (lack of oxygen), botulism toxin may be formed.

Packaging defects may not be readily apparent. This is particularly the case with low acid canned foods. Close inspection of cans for imperfections or damage may reveal punctures or seam defects. In many cases, suspect packaging may have to be inspected by trained persons using magnifying equipment. Irreversible and even reversible swelling of cans (hard swells and flippers) may indicate can damage or imperfections (lack of an airtight, i.e. hermetic seal). Swollen cans may also indicate that not enough heat was applied during processing (underprocessing). Suspect cans must be returned and not offered for sale.

3-202.16 Ice.

Freezing does not invariably kill microorganisms; on the contrary, it may preserve them. Therefore, ice that comes into contact with food to cool it or that is used directly for consumption must be as safe as drinking water that is periodically tested and approved for consumption.

3-202.17 Shucked Shellfish, Packaging and Identification.

Plastic containers commonly used throughout the shellfish industry for shucked product bear specific information regarding the source of the shellfish as required by the NSSP Guide for the Control of Molluscan Shellfish. These containers must be nonreturnable so that there is no potential for their subsequent reuse by shellfish packers which could result in shucked product that is inaccurately identified by the label. The reuse of these containers within the food establishment must be assessed on the basis of the Food Code's criteria for multi-use containers and the likelihood that they will be properly relabeled to reflect their new contents.

3-202.18 Shellstock Identification.

Accurate source identification of the harvesting area, harvester, and dealers must be contained on molluscan shellstock identification tags so that if a shellfish-borne disease outbreak occurs, the information is available to expedite the epidemiological investigation and regulatory action.

3-202.19 Shellstock, Condition.

Dirty, damaged, or dead shellstock can contaminate and degrade live and healthy shellstock and lead to foodborne illness. Harvesters have the primary responsibility for culling shellstock, but this responsibility continues throughout the distribution chain.

3-202.110 Juice Treated.

Refer to public health reason for § 3-801.11.

Original Containers and Records

3-203.11 Molluscan Shellfish, Original Container.

Lot separation is critical to isolating shellfish implicated in illness outbreaks and tracking them to their source. Proper identification is needed for tracing the origin and determining conditions of shellfish processing and shipment. If the lots are commingled at retail, traceability is undermined and the root of the problem may remain undetected. If no causative factors are identified in the food establishment, tracing the incriminated lot helps in identifying products that need to be recalled or growing waters that may need to be closed to harvesting.

When shucked shellfish are prepackaged in consumer self service containers, the labeling information as specified under section 3-202.17 must be recorded on a log sheet to correlate with the date of sale of the consumer sized containers.

Accurate records that are maintained in a manner that allows them to be readily matched to each lot of shellstock provide the principal mechanism for tracing shellstock to its original source. If an outbreak occurs, regulatory authorities must move quickly to close affected growing areas or take other appropriate actions to prevent further illnesses. Records must be kept for 90 days to allow time for hepatitis A virus infections, which have an incubation period that is significantly longer than other shellfish-borne diseases, to come to light. The 90 day requirement is based on the following considerations:

Shelf-life of the product

Category: Forex

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