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Public Health Service Food and Drug Administration 1999 Food Code |
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Annex 3 |
CHAPTER 1 PURPOSE AND DEFINITIONS
CHAPTER 2 MANAGEMENT AND PERSONNEL
CHAPTER 3 FOOD
CHAPTER 4 EQUIPMENT, UTENSILS, AND LINENS
CHAPTER 5 WATER, PLUMBING, AND WASTE
CHAPTER 6 PHYSICAL FACILITIES
CHAPTER 7 POISONOUS OR TOXIC MATERIALS
Chapter 1 Purpose and Definitions |
(B)(1) Accredited Program.
Food protection manager certification occurs when individuals demonstrate through a certification program that they have met specified food safety knowledge standards.
Food protection certification program accreditation occurs when certification organizations demonstrate through an accreditation program that they have met specified program standards.
Accreditation is a conformity assessment process through which organizations that certify individuals may voluntarily seek independent evaluation and listing by an accrediting agency based upon the certifying organization's meeting program accreditation standards. Such accreditation standards typically relate to such factors as the certifying organization's structure, mission, policies, procedures, and the defensibility of its examination processes. These standards are intended to affirm or enhance the quality and credibility of the certification process, minimize the potential for conflicts of interest, ensure fairness to candidates for certification and others, and thereby increase public health protection.
Program accreditation standards known to be relevant to food protection manager certification programs include those contained in the draft Standards for the Training, Testing, and Certification of Food Protection Managers available from the Conference for Food Protection, 110 Tecumseh Trail, Frankfort, KY 40601. Also included are the National Commission for Certifying Agencies' Standards for Accreditation of National Certification Organizations available through the National Organization for Competency Assurance, 1200 19th Street, NW, Suite 300, Washington, DC 20036-2422.
Allowing food protection managers to demonstrate their required food safety knowledge "through passing a test that is part of an accredited program" is predicated on the fact that their credentials have been issued by certifying organizations that have demonstrated conformance with rigorous and nationally recognized program standards.
Chapter 2 Management and Personnel |
Designation of a person in charge during all hours of operations ensures the continuous presence of someone who is responsible for monitoring and managing all food establishment operations and who is authorized to take actions to ensure that the Code's objectives are fulfilled. During the day-to-day operation of a food establishment, a person who is immediately available and knowledgeable in both operational and Code requirements is needed to respond to questions and concerns and to resolve problems.
The designated person in charge who is knowledgeable about foodborne disease prevention, Hazard Analysis and Critical Control Point (HACCP) principles, and Code requirements is prepared to recognize conditions that may contribute to foodborne illness or that otherwise fail to comply with Code requirements, and to take appropriate preventive and corrective actions.
There are many ways in which the person in charge can demonstrate competency. Many aspects of the food operation itself will reflect the competency of that person. A dialogue with the person in charge during the inspection process will also reveal whether or not that person is enabled by a clear understanding of the Code and its public health principles to follow sound food safety practices and to produce foods that are safe, wholesome, unadulterated, and accurately represented.
The effectiveness of the person in charge in protecting the health of the consumer is evidenced by the person's ability to apply the required knowledge to the establishment's operations by designing and implementing procedures that ensure continued compliance with the Code.
Presently there are a wide variety of industry management training and certification programs being offered by regulatory agencies, academic institutions, food companies, industry groups and "third-party" organizations. Most certification programs share a common desire to have the food manager certificate they issue universally recognized and accepted by others - especially by the increasing number of regulatory authorities that require food manager certification.
Certification programs vary significantly in focus and primary mission of sponsors, organizational structures, staff resources, revenue sources, testing mechanisms, policies toward applicants and employers of food managers, and policies pertaining to such things as public information, criteria for maintaining certification, and the need for recertification. Where courses are offered, they vary in scope, content, depth and duration, quality of instructional materials, qualifications of instructors, and instructional approach (classroom, on-the-job, PC-based, home study, etc.). Where testing is a program component, varying degrees of attention are given to test construction and test administration as they relate to nationally accepted standards (reliability, validity, job analysis, subject weighting, cut scores, test security, etc.).
Needed is a mechanism for regulatory authorities to use in determining which certificates should be considered credible based on which certificate-issuing programs meet sound organizational and certification procedures and use defensible processes in their test development and test administration.
Considerable progress has been made by the Conference for Food Protection toward providing the standards and procedures necessary for the independent evaluation and accreditation of food protection manager certification programs. The Conference is simultaneously working on two separate aspects of the program accreditation process.
The first aspect addresses the important matter of ensuring that examinations are reliable, valid, and legally defensible. The Conference has developed a process for the independent evaluation and recognition of food protection manager certification examinations that meet its standards for test development and test administration. It is projected that this aspect of the process will be announced and become available to test providers in early 1999.
The second aspect addresses the equally important organizational and operational policies and procedures of a certification program that help ensure honesty and fairness for all stakeholders and protect against conflict of interests. The Conference is working closely with national organizations that have considerable experience with the accreditation of certification programs, and is endeavoring to develop a comparable process for evaluating these aspects of a certification program.
Once the Conference completes its work on these two program components, program accreditation may become the needed mechanism for promoting the universal acceptance of certificates issued by accredited certifiers.
A primary responsibility of the person in charge is to ensure compliance with Code requirements. Any individual present in areas of a food establishment where food and food-contact items are exposed presents a potential contamination risk. By controlling who is allowed in those areas and when visits are scheduled and by assuring that all authorized persons in the establishment, such as delivery, maintenance and service personnel, and pest control operators, comply with the Code requirements, the person in charge establishes an important barrier to food contamination.
Tours of food preparation areas serve educational and promotional purposes; however, the timing of such visits is critical to food safety. Tours may disrupt standard or routine operational procedures, and the disruption could lead to unsafe food. By scheduling tours during nonpeak hours the opportunities for contamination are reduced.
A wide range of communicable diseases and infections may be transmitted by infected food employees to consumers through food or food utensils. Proper management of a food establishment operation begins with employing healthy people and instituting a system of identifying employees who present a risk of transmitting foodborne pathogens to food or to other employees. In order to protect the health of both consumers and employees, information concerning the health status of applicants and food employees must be disclosed to the person in charge.
Title I of the Americans with Disabilities Act of 1990 (ADA) prohibits medical examinations and inquiries as to the existence, nature, or severity of a disability before extending a conditional offer of employment. In order for the permit holder and the person in charge to be in compliance with this particular aspect of the Code and the ADA, a conditional job offer must be made before making inquiries about the applicant's health status.
Furthermore, an applicant to whom an employment offer is conditionally made or a food employee who meets the Code conditions that require restriction from certain duties or exclusion must be accommodated to the extent provided under the ADA. That is, if there is an accommodation that will not pose an undue hardship and that will prevent the transmission of the disease(s) of concern through food, such accommodation, e.g., reassignment to duties that fulfill the intent of restriction or exclusion, must be made. It should be noted that the information provided here about the ADA is intended to alert employers to the existence of ADA and related CFR requirements. For a comprehensive understanding of the ADA and its implications, consult the references listed in the References Annex that relate to this section of the Code or contact the U. S. Equal Employment Opportunity Commission.
The information required from applicants and food employees is designed to identify employees who may be suffering from a disease which can be transmitted through food. It is the responsibility of the permit holder to convey to applicants and employees the importance of notifying the person in charge of changes in their health status. Once notified, the person in charge can take action to prevent the likelihood of the transmission of foodborne illness.
Applicants, to whom a conditional offer of employment is extended, and food employees are required to report specific high-risk conditions, medical symptoms, and previous illnesses. The symptoms listed may be indicative of a disease that is transmitted through the food supply by infected food employees.
As required by the ADA, on August 5, 1996, the Centers for Disease Control and Prevention (CDC) published a list of infectious and communicable diseases that are transmitted through food. CDC updates the list annually. The list is divided into two parts: pathogens often transmitted (List I) and pathogens occasionally transmitted (List II) through food by infected food employees.
The Lists below summarize the CDC list by comparing the common symptoms of each pathogen. Symptoms may include diarrhea, fever, vomiting, jaundice, and sore throat with fever. CDC has no evidence that the HIV virus is transmissible via food. Therefore, a food employee positive for the HIV virus is not of concern unless suffering secondary illness listed below.
| LIST I. | Pathogens Often Transmitted by Food Contaminated by Infected Employees. | |||||
| D | F | V | J | S | ||
| 1. Hepatitis A virus | - | F | - | J | - | |
| 2. Salmonella Typhi | - | F | - | - | - | |
| 3. Shigella species | D | F | V | - | - | |
| 4. Norwalk and Norwalk-like viruses | D | F | V | - | - | |
| 5. Staphylococcus aureus | D | - | V | - | - | |
| 6. Streptococcus pyogenes | - | F | - | - | S | |
| LIST II. | Pathogens Occasionally Transmitted by Food Contaminated by Infected Employees. | |||||
| D | F | V | J | S | ||
| 1. Campylobacter jejuni | D | F | V | - | - | |
| 2. Entamoeba histolytica | D | F | - | - | - | |
| 3. Enterohemorrhagic Escherichia coli | D | - | - | - | - | |
| 4. Enterotoxigenic Escherichia coli | D | - | V | - | - | |
| 5. Giardia lamblia | D | - | - | - | - | |
| 6. Non-typhoidal Salmonella | D | F | V | - | - | |
| 7. Rotavirus | D | F | V | - | - | |
| 8. Taenia solium | - | - | - | - | - | |
| 9. Vibrio cholerae 01 | D | - | V | - | - | |
| 10. Yersinia enterocolitica | D | F | V | - | - | |
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The symptoms listed in the Code cover the common symptoms experienced by persons suffering from the pathogens identified by CDC as transmissible through food by infected food employees. An employee suffering from any of the symptoms listed presents an increased risk of transmitting foodborne illness.
The high-risk conditions that require reporting are designed to be used with the symptoms listed to identify employees who may be suffering from an illness due to the following pathogens: Salmonella Typhi, Shigella spp., Escherichia coli O157:H7, and hepatitis A virus. The specific conditions requiring reporting were identified by CDC as significant contributing factors to the incidence of foodborne illness.
The 4 organisms listed have been designated by CDC as having high infectivity. This designation is based on the number of confirmed cases reported that involved food employees infected with one of these organisms and the severity of the medical consequences to those who become ill.
Lesions containing pus that may occur on a food employee's hands, as opposed to such wounds on other parts of the body, represent a direct threat for introducing Staphylococcus aureus into food. Consequently, a double barrier is required to cover hand and wrist lesions. Pustular lesions on the arms are less of a concern when usual food preparation practices are employed and, therefore, a single barrier is allowed. However, if the food preparation practices entail contact of the exposed portion of the arm with food, a barrier equivalent to that required for the hands and wrists would be necessitated. Lesions on other parts of the body need to be covered; but, an impermeable bandage is not considered necessary for food safety purposes. Food employees should be aware that hands and fingers that contact pustular lesions on other parts of the body or with the mucous membrane of the nose also pose a direct threat for introducing Staphylococcus aureus into food.
Restriction or exclusion of food employees suffering from a disease or medical symptom listed in the Code is necessary due to the increased risk that the food being prepared will be contaminated with a pathogenic organism transmissible through food. A person suffering from any of the symptoms or medical conditions listed may be suffering from a disease transmissible through food.
Because of the high infectivity (ability to invade and multiply) and virulence (ability to produce severe disease) of Salmonella Typhi, Shigella spp., Escherichia coli O157:H7, and hepatitis A virus, a food employee diagnosed with an active case of illness caused by any of these four pathogens must be excluded from food establishments. The exclusion is based on the severe medical consequences to individuals infected with these organisms, i.e., hospitalization and even death.
Restrictions and exclusions vary according to the population served because highly susceptible populations have increased vulnerability to foodborne illness. For example, foodborne illness in a healthy individual may be manifested by mild flu-like symptoms. The same foodborne illness may have serious medical consequences in immunocompromised individuals. This point is reinforced by statistics pertaining to deaths associated with foodborne illness caused by Salmonella Enteritidis. Over 70% of the deaths attributed to this organism occurred among individuals who for one reason or another were immunocompromised. This is why the restrictions and exclusions listed in the Code are especially stringent for food employees serving highly susceptible populations.
The symptoms experienced by individuals infected with Salmonella Typhi, Shigella spp., Escherichia coli O157:H7, or hepatitis A virus are often severe and of sufficient duration that most employees will seek medical assistance. The Code provisions related to individuals who encounter any of the high-risk conditions listed and also suffer from any of the symptoms listed in the Code are designed to identify individuals who are likely to be suffering from an illness caused by 1 of the 4 organisms that requires exclusion.
Periodic testing of food employees for the presence of diseases transmissible through food is not cost effective or reliable. Therefore, restriction and exclusion provisions are triggered by the active symptoms and high-risk conditions listed. A high-risk condition alone does not trigger restriction or exclusion. The employee must also suffer from one of the symptoms listed.
The use of high-risk conditions alone as the sole basis for restricting or excluding food employees is difficult to justify. The high-risk conditions that must be reported apply only to the 4 organisms listed. Of the 4 organisms listed, hepatitis A presents a different twist to this rationale. Food employees who meet a high-risk condition involving hepatitis A may shed the virus before becoming symptomatic. In fact, the infected employee could be shedding hepatitis A virus for up to a week before experiencing symptoms of the infection. However, even in light of this fact, blanket exclusion or restriction of a food employee solely because of a high-risk condition involving hepatitis A is not justified.
The following summarize the rationale for not restricting or excluding an asymptomatic food employee simply because the employee meets a high-risk condition involving hepatitis A:
Based on the information presented, exclusion or restriction solely on a high-risk condition would be potentially controversial and of questionable merit.
Because of the high infectivity of hepatitis A, the person in charge or regulatory authority should handle employees and applicants who meet a high-risk condition involving hepatitis A on a case-by-case basis. With this approach in mind, the following criteria are offered as a guide. First, the following information should be collected and analyzed:
In addition, upon being notified of the high-risk condition, the person in charge should immediately:
If after consideration of all the information gathered, the person in charge feels that the employee in question is likely to develop hepatitis A, restriction or exclusion of the individual's activities should be considered.
Chapter 2 provisions related to employee health are structured to recognize certain characteristics of each of the four infectious agents, the risk of illness presented by asymptomatic shedders, the increased risk to highly susceptible populations, and the need to provide extra protection to those high-risk populations.
Asymptomatic shedders are food employees who do not exhibit the symptoms of foodborne illness but who are identified through laboratory analysis of their stools to have any one of the three bacterial pathogens identified in Chapter 2 in their gastrointestinal system.
The duties that an asymptomatic shedder performs in a food establishment are restricted if the establishment serves a general population or, if a highly susceptible population is involved, the shedder is excluded. Several considerations factor into the need to preclude asymptomatic shedders from food establishment functions that may result in the transmission of foodborne disease.
The risk that a communicable disease will be transmitted by food employees who are asymptomatic shedders varies depending upon the hygienic habits of the worker, the food itself and how it is prepared, the susceptibility of the population served, and the infectivity of the organism.
To minimize the risk in all food establishments of the transmission of foodborne disease by an asymptomatic shedder and based on the factors listed above, all known asymptomatic shedders of the three bacterial pathogens are either restricted or excluded, depending on the population served. Requiring restriction for asymptomatic shedders of all three of the bacterial pathogens results in a uniform criterion and is consistent with APHA-published recommendations in the "Control of Communicable Diseases in Man."
The Code requires medical clearance, based on criteria designed to detect the shedder state, before a person who had a recent illness from, or is identified as a shedder of any of the three bacterial infectious agents is allowed to resume the duties from which that person was restricted or, in the case of an establishment that serves a highly susceptible population, before the person may return to work.
With respect to a food employee in an establishment that serves an immunocompromised population, the Code provisions are more stringent in that exclusion is required in 3 situations in which it is not required for food employees in other food establishments. Those 3 situations involve an employee who:
(A) Meets a high-risk condition specified in ¶ 2-201.11(D) and has a symptom of acute gastrointestinal illness;
(B) Is diagnosed as an asymptomatic shedder of S. Typhi, Shigella spp. or Escherichia coli O157:H7; or
(C) Had a recent illness caused by S. Typhi, Shigella spp., or E. coli O157:H7. The exclusion is in effect until a physician licensed to practice medicine or, if allowed by law, a nurse practitioner or physician assistant, provides the medical clearance specifically outlined in § 8-501.40 of the Code, indicating that the infectious agent is not detected.
This reporting requirement is an important component of any food safety program. A food employee who suffers from any of the illnesses or medical symptoms or meets any of the high-risk conditions in this Code may transmit disease through the food being prepared. The person in charge must first be aware that an employee or prospective employee is suffering from a disease or symptom listed in the Code before steps can be taken to reduce the chance of foodborne illness.
Some of the symptoms that must be reported may be observed by the person in charge. However, food employees and applicants share a responsibility for preventing foodborne illness and are obligated to inform the person in charge if they are suffering from any of the symptoms, high-risk conditions, or medical diagnoses listed in the Code and food employees must comply with restrictions or exclusions imposed upon them.
Notification of the regulatory authority by the person in charge that an employee is suffering illness caused by Salmonella Typhi, Shigella spp., Escherichia coli O157:H7, or hepatitis A virus allows the regulatory authority to monitor for any associated cases of foodborne illness. The person in charge should be aware of the confidentiality provisions of the Americans with Disabilities Act (ADA). For information about the ADA, call 800-669-EEOC or for telecommunications device for the deaf (TDD) 800-800-3302.
The hands are particularly important in transmitting foodborne pathogens. Food employees with dirty hands and/or fingernails may contaminate the food being prepared. Therefore, any activity which may contaminate the hands must be followed by thorough handwashing in accordance with the procedures outlined in the Code.
Even seemingly healthy employees may serve as reservoirs for pathogenic microorganisms that are transmissible through food. Staphylococci, for example, can be found on the skin and in the mouth, throat, and nose of many employees. The hands of employees can be contaminated by touching their nose or other body parts.
Many employees fail to wash their hands as often as necessary and even those who do may use a flawed technique. It takes more than just the use of soap and running water to remove the transient pathogens that may be present. It is the abrasive action obtained by vigorously rubbing the surfaces being cleaned that loosens the dirt or soil present.
Many of the diseases that are transmissible through food may be harbored in the employee's intestinal tract and shed in the feces. Proper handwashing by employees after defecation establishes a protective barrier against the transmission of pathogens that may be present in the feces.
Pathogens transmissible through food may also be present in other body fluids. Therefore, precautions would be appropriate whenever an employee handles body fluids or body wastes directly or indirectly, because of the increased risk of the presence of disease. Fecal material and other contaminants routinely accumulate under the fingernails; therefore, particular attention must be given to the fingernails, fingertips, and areas between the fingers. Once the material and soil are loosened, they can be washed away in the rinsing step of proper handwashing.
This section is reserved.
In earlier editions of the Code, FDA's model contained a provision for a Special Procedure in certain situations. Pursuant to a 1996 Conference for Food Protection (CFP) Recommendation, the text of this Code provision is removed and the section is reserved. It is FDA's intent to further research the matter and to submit the findings to the CFP for reconsideration of the matter.
The hands may become contaminated when the food employee engages in specific activities. The increased risk of contamination requires handwashing immediately after the activities listed. The specific examples listed in this Code section are not intended to be all inclusive. Employees must wash their hands after any activity which may result in contamination of the hands.
Effective handwashing is essential for minimizing the likelihood of the hands becoming a vehicle of cross contamination. It is important that handwashing be done only at a properly equipped handwashing facility in order to help ensure that food employees effectively clean their hands. Handwashing facilities are to be conveniently located, always accessible for handwashing, maintained so they provide proper water temperatures and pressure, and equipped with suitable hand cleansers, nail brushes, and disposable towels and waste containers, or hand dryers. It is inappropriate to wash hands in a food preparation sink since this may result in avoidable contamination of the sink and the food prepared therein. Service sinks may not be used for food employee handwashing since this practice may introduce additional hand contaminants because these sinks may be used for the disposal of mop water, toxic chemicals, and a variety of other liquid wastes. Such wastes may contain pathogens from cleaning the floors of food preparation areas and toilet rooms and discharges from ill persons.
This provision is intended to ensure that an antimicrobial product applied to the hands is both, 1) safe and effective when applied to human skin, and 2) a safe food additive when applied to bare hands that will come into direct contact with food. The prohibition against bare hand contact contained in ¶ 3-301.11(B) applies only to an exposed ready-to-eat food.
As a Drug Product
There are three means by which a hand sanitizer is considered to be safe and effective when applied to human skin:
Products having the same formulation, labeling, and dosage form as those that existed in the marketplace on or before December 4, 1975 or that are authorized by USDA are being evaluated under the OTC (over-the-counter) Drug Review by FDA's Center for Drug Evaluation and Research. Otherwise, the far more extensive FDA review process for a new drug application (NDA) is required before marketing.
However, as of the end of 1998, no hand sanitizers have been shown to be acceptable through this process since the monograph has not been finalized. FDA's Center for Drug Evaluation and Research is not presently objecting to the use of "instant hand sanitizers" based on ethyl alcohol or isopropyl alcohol, or certain chlorine "hand sanitizing dips" since these compounds are included in the OTC Drug Review. The ultimate status of these products will not be known until the final monograph publishes.
Acceptable antimicrobial ingredients for hand sanitizers will be identified in a future final monograph issued under the OTC Drug Review for OTC Antiseptic Handwashes. Information about whether a specific product has been accepted and included in the proposed monograph may be obtained from the manufacturer. You may also refer to Federal Register (59) No. 116, June 17, 1994, Tentative Final Monograph (TFM) for Health Care Antiseptic Drug Products; Proposed Rule. This TFM describes the inclusion of hand sanitizers in this Review, on page 31440 under Comment 28 of Part II.
This USDA publication lists acceptable employee hand-care products in all four categories. The USDA review is based only on the intended uses specified for the product by the manufacturer in a written application. However, during the second half of 1998, USDA discontinued this review program and listing. It is unknown at this time whether another organization will assume some or all of these review and listing responsibilities.
Products in all four of these USDA listed hand-care product categories are regulated by FDA's Center for Drug Evaluation and Research. Questions regarding acceptability of a hand sanitizer with respect to OTC compliance may be directed to the OTC Compliance Team, HFD-312, Division of Labeling and Nonprescription Drug Compliance, Office of Compliance, Center for Drug Evaluation and Research, 7520 Standish Place, Rockville, MD 20855-2737. Specific product label/promotional information and the formulation are required for determining a product's regulatory status.
As a Food Additive
To be regulated under the food additive provisions of the Federal Food, Drug, and Cosmetic Act, the components of a hand-care product must reasonably be expected to become a component of food based upon the product's intended use. E-3 formulations in USDA's E-Classification system meet this criterion.
Where the components of a product are reasonably expected to become a component of food based upon the product's intended use, there are three means by which they are considered by FDA to be safe:
Only USDA's E-3 category products are regulated by FDA's Center for Food Safety and Applied Nutrition. The Indirect Additives Team does not certify or provide approvals for specific products. However, if the use of a product meets the regulations of 21 CFR 170.39 Threshold of regulation for substances used in food-contact articles, FDA may provide a letter to a firm stating that the use of this product is exempt from the requirement of a food additive listing regulation. However, the product must be the subject of a new drug application or under FDA's OTC Drug Review to be legally marketed.
Questions regarding the regulatory status of hand sanitizer components as food additives may be directed to the Indirect Additives Team, HFS-215, Office of Premarket Approval, Center for Food Safety and Applied Nutrition, 200 C Street, SW, Washington, DC 20204. It may be helpful or necessary to provide label/promotional information when inquiring about a specific component.
The requirement for fingernails to be trimmed, filed, and maintained is designed to address both the cleanability of areas beneath the fingernails and the possibility that fingernails or pieces of the fingernails may end up in the food due to breakage. Failure to remove fecal material from beneath the fingernails after defecation can be a major source of pathogenic organisms. Ragged fingernails present cleanability concerns and may harbor pathogenic organisms.
Items of jewelry such as rings, bracelets, and watches may collect soil and the construction of the jewelry may hinder routine cleaning. As a result, the jewelry may act as a reservoir of pathogenic organisms transmissible through food.
An additional hazard associated with jewelry is the possibility that pieces of the item or the whole item itself may fall into the food being prepared. Hard foreign objects in food may cause medical problems for consumers, such as chipped and/or broken teeth and internal cuts and lesions.
Dirty clothing may harbor diseases that are transmissible through food. Food employees who inadvertently touch their dirty clothing may contaminate their hands. This could result in contamination of the food being prepared. Food may also be contaminated through direct contact with dirty clothing. In addition, employees wearing dirty clothes send a negative message to consumers about the level of sanitation in the establishment.
Food preparation areas such as hot grills may have elevated temperatures and the excessive heat in these areas may present a medical risk to the workers as a result of dehydration. Consequently, in these areas food employees are allowed to drink from closed containers that are carefully handled.
Discharges from the eyes, nose, or mouth through persistent sneezing or coughing by food employees can directly contaminate exposed food, equipment, utensils, linens, and single-service and single-use articles. When these poor hygienic practices cannot be controlled, the employee must be assigned to duties that minimize the potential for contaminating food and surrounding surfaces and objects.
Consumers are particularly sensitive to food contaminated by hair. Hair can be both a direct and indirect vehicle of contamination. Food employees may contaminate their hands when they touch their hair. A hair restraint keeps dislodged hair from ending up in the food and may deter employees from touching their hair.
Dogs and other animals, like humans, may harbor pathogens that are transmissible through food. Handling or caring for animals that may be legally present is prohibited because of the risk of contamination of food employee hands and clothing.
Chapter 3 Food |
Refer to the public health reason for § 3-401.11.
Source
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 consmers 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 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.
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. At the time of publication of the 1999 Food Code, rulemaking had not been finalized regarding a mandatory Hazard Analysis Critical Control Point (HACCP) program for juice products.
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. Untreated juices or beverages containing untreated juices that are offered to consumers as prepackaged foods must bear a 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." Additional information is available in the document, "Guidance for Industry. Warning and Notice Statement: Labeling of Juice Products, Small Entity Compliance Guide" which can be found on the FDA Web Page http://www.cfsan.fda.gov/~dms/juicguid.html or obtained from the FDA Office of Food Labeling.
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. 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 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 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.
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.
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 Escherichia coli O157:H7, 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.
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 Scrombridae, 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.
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 mollluscan 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 mulluscan 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.
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.
Refer also to the public health reason for §§ 3-101.11 and 3-201.11.
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.
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. Effective August 27, 1999, federal regulations 7 CFR Part 59, Refrigeration and Labeling Requirements for Shell Eggs, (currently printed in the Federal Register, 63(166): 45663-45675) require shell eggs to be stored and transported in an ambient air temperature of no greater than 7°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.
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.
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.
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. 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.
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.
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.
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.
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.
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.
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.
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 | 14 days |
| Incubation period | 56 days |
| Medical diagnosis and confirmation | 5 days |
| Reporting | 5 days |
| Epidemiological investigation | 10 days |
| --------------- | ----- |
| Total | 90 days |
Refer to the public health reasons for §§ 2-301.11, 2-301.12, and 2-301.13.
Even though bare hands should never contact exposed, ready-to-eat food, thorough handwashing is important in keeping gloves or other utensils from becoming vehicles for transferring microbes to the food.
Clarification of ¶ 3-301.11(B) of the FDA Food Code with Respect to the Phrase
"Except...when otherwise APPROVED"...
Background:
Infected food employees are the source of contamination in approximately one in five foodborne disease outbreaks reported in the United States with a bacterial or viral cause.1 Most of these outbreaks involve enteric, i.e., fecal-oral agents. These are organisms that employees were shedding in their stools at the time the food was prepared. Because of poor or nonexistent handwashing procedures, workers spread these organisms to the food. In addition, infected cuts, burns, or boils on hands can also result in contamination of food. Viral, bacterial, and parasitic agents can be involved.
Traditionally, food regulations have required two methods of preventing the spread of foodborne disease by this mode of transfer, i.e., they have prohibited food workers from preparing food when they are infectious and have required thorough and frequent handwashing. In order to strengthen fecal-oral transmission interventions, the Food Code provides focused and specific guidance about ill workers and when handwashing must occur. As a final barrier, bare-hand contact with ready-to-eat food (i.e., food that is edible without washing or is not subsequently subjected to a pathogen kill step) is prohibited and suitable utensils such as spatulas, tongs, single-use gloves, or dispensing equipment are required to be used. Any alternative to this requirement must convincingly address how food employees will be managed to preclude food contamination and how management will ensure that thorough handwashing occurs after employees use the toilet.
Objective:
The objective of this guidance is to provide clarification to ¶ 3-301.11(B) of the Food Code regarding the statement "except when otherwise approved." This guidance is provided to assist the regulatory authority in evaluating conformity with the principle of no bare-hand contact through alternative practices and procedures. In this guidance, "hazard" means infected food workers spreading pathogens to food via the hands.
Guidance:
I. Requirements prerequisite to consideration of alternatives include compliance with all Food Code provisions, particularly those related to:
(B) Duties of the Person in Charge - specifically ¶ 2-103.11(D);
(C) Employee Health regarding:
(2) Exclusions and restrictions, i.e., that food employees (including applicants to whom a conditional offer of employment has been made) report their health status as specified in Section 2-201.11; ill food employees are restricted or excluded as specified in Section 2-201.12; and the exclusions and restrictions are removed as specified in Section 2-201.13;
(D) Personal Cleanliness, i.e., handwashing procedures, including frequency and methodology of handwashing that ensure food employees keep their hands and fingertips clean and handwashing occurs at the times specified in Section 2-301.14 - including after using the toilet and between tasks that may recontaminate the hands; and
(E) Hygienic Practices as specified in Part 2-4.
II. FDA recommends that the acceptability of an alternative to no bare-hand contact should be based on evidence that at least the following are addressed:
(B) How the alternative practices and procedures will control the hazard through an active managerial control program. Such a program includes monitoring and verifying the institution of the prerequisite requirements described in Part I above and satisfies the following:
(2) The ready-to-eat foods that will be contacted with bare hands are identified and both procedures and practices are in place so that food employees wash their hands before returning to their work station and cross-contamination from touching raw and ready-to-eat food is precluded.
Another example could be a food employee who is responsible solely for assembling a variety of ready-to-eat foods.
(3) Institution of an effective training program for food employees which emphasizes not working when ill with any of the symptoms of foodborne illness, and explains good hygienic practices, proper handwashing procedures, and safe food preparation procedures. This should include a documented training plan that specifies how management responsibility for training has been designated, training program content, and the frequency of administration including periodic refresher sessions.
(C) The alternative should clearly include monitoring, documentation, and verification to ensure that the practices and procedures are followed. Corrective actions need to be predetermined for situations where the practices and procedures are not followed, e.g., an ill employee is found preparing foods.
III. Documentation of the practices, procedures, and corrective actions related to an alternative to no bare-hand contact with ready-to-eat food needs to be maintained and readily available at the food establishment at all times for use by the person-in-charge and for review by the regulatory authority.
IV. The regulatory authority should also consider industry's elective use, managerial control, and monitoring and verification of additional preventive measures used in tandem with the aforementioned interventions which could include one or more of the following:
(B) Double handwashing;
(C) Use of nail brushes;
(D) Use of an FDA-accepted hand sanitizer after handwashing, i.e., approved as safe for application to human skin and safe as an indirect food additive, or exempted as a food additive under 21 CFR 170.39 Threshold of Regulation for Substances Used in Food Contact Articles; and
(E) Motivation for food employees not to work when they are ill.
Cross contamination can be avoided by separating raw animal foods from ready-to-eat foods. Cross contamination may also occur when raw unprepared vegetables contact ready-to-eat potentially hazardous foods. Raw animal foods must also be separated from each other because required cooking temperatures are based on thermal destruction data and anticipated microbial load. These parameters vary with different types of raw animal foods.
Food that is inadequately packaged or contained in damaged packaging could become contaminated by microbes, dust, or chemicals introduced by products or equipment stored in close proximity or by persons delivering, stocking, or opening packages or overwraps.
Packaging must be appropriate for preventing the entry of microbes and other contaminants such as chemicals. These contaminants may be present on the outside of containers and may contaminate food if the packaging is inadequate or damaged, or when the packaging is opened. The removal of food product overwraps may also damage the package integrity of foods under the overwraps if proper care is not taken.
Certain foods may be difficult to identify after they are removed from their original packaging. Consumers may be allergic to certain foods or ingredients. The mistaken use of an ingredient, when the consumer has specifically requested that it not be used, may result in severe medical consequences.
The mistaken use of food from unlabeled containers could result in chemical poisoning. For example, foodborne illness and death have resulted from the use of unlabeled salt, instead of sugar, in infant formula and special dietary foods. Liquid foods, such as oils, and granular foods that may resemble cleaning compounds are also of particular concern.
Raw or undercooked eggs that are used in certain dressings or sauces are particularly hazardous because the virulent organism Salmonella Enteritidis may be present in raw shell eggs. Pasteurized eggs provide an egg product that is free of pathogens and is a ready-to-eat food. The pasteurized product should be substituted in a recipe that requires raw or undercooked eggs.
Refer to the public health reason for § 3-202.12.
Use of unapproved additives, or the use of approved additives in amounts exceeding those allowed by food additive regulations could result in foodborne illness, including allergic reactions. For example, many adverse reactions have occurred because of the indiscriminate use of sulfites to retard "browning" of fruits and vegetables or to cause ground meat to look "redder" or fresher.
The concern for misuse of additives also applies to food establishments operating under a variance and to Annex 6 Food Processing Criteria which addresses the use of sodium nitrite or other curing agents in smoking and curing operations. However, if this process is done incorrectly, it could cause illness or death because of excessive nitrite or because the food is insufficiently preserved.
Pathogenic organisms and chemicals may be present on the exterior surfaces of raw fruits and vegetables. Washing removes the majority of organisms and/or chemicals present. If nondrinking water is used, the fruits and vegetables could become contaminated.
Toxic or undesirable residues could be present in or on the food if chemicals used for washing purposes are unapproved or applied in excessive concentrations.
On October 26, 1998 a voluntary guidance document which addresses practices commonly used by fresh fruit and vegetable producers was issued jointly by FDA, USDA, and CDC. This voluntary guidance contains useful information related to washing fruits and vegetables as well as the application of antimicrobial agents. The "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" is available from FDA's Food Safety Initiative staff and also on the Internet at http://www.fda.gov.
Ice that has been in contact with unsanitized surfaces or raw animal foods may contain pathogens and other contaminants. For example, ice used to store or display fish or packaged foods could become contaminated with microbes present on the fish or packaging. If this ice is then used as a food ingredient, it could contaminate the final product.
Packages that are not watertight may allow entry of water that has been exposed to unsanitary exterior surfaces of packaging, causing the food to be contaminated. This may also result in the addition of water to the food that is unclaimed in the food's formulation and label.
Unpackaged foods such as fresh fish are often stored and/or displayed on ice. A potential for increasing the microbial load of a food exists because, as the ice melts, pathogens from one food may be carried by water to other foods. The potential for contamination is reduced by continuous draining of melting ice.
Pathogens can be transferred to food from utensils that have been stored on surfaces which have not been cleaned and sanitized. They may also be passed on by consumers or employees directly, or indirectly from used tableware or food containers.
Some pathogenic microorganisms survive outside the body for considerable periods of time. Food that comes into contact directly or indirectly with surfaces that are not clean and sanitized is liable to such contamination. The handles of utensils, even if manipulated with gloved hands, are particularly susceptible to contamination.
Probe-type price or identification tags are defined as a utensil. This means that if such tags are for multiuse, they must meet the criteria listed in Parts 4-1 Materials for Construction and Repair, and 4-2 Design and Construction. Probe-type price or product identification tags can cause microbial, chemical, or physical contamination if not properly designed, constructed, and maintained.
Refer to the public health reason for § 3-304.11.
Once a food employee begins to use a utensil such as a ladle, spatula, or knife, that has been previously cleaned and sanitized, it is then considered an in-use utensil. In-use utensils, used on a continuous or intermittent basis during preparation or dispensing, must be cleaned and sanitized on a schedule that precludes the growth of pathogens that may have been introduced onto utensil surfaces. In-use utensils may be safely stored in hot water maintained at 140°F or above during intermittent use because microbial growth is controlled at such temperatures.
Refer to the public health reason for § 3-304.11.
Because of their absorbency, linens and napkins used as liners that contact food must be replaced whenever the container is refilled. Failure to replace such liners could cause the linens or napkins to become fomites.
Refer to the public health reason for § 3-304.11.
Soiled wiping cloths, especially when moist, can become breeding grounds for pathogens that could be transferred to food. Any wiping cloths that are not dry (except those used once and then laundered) must be stored in a sanitizer solution at all times, with the proper sanitizer concentration in the solution. Wiping cloths soiled with organic material can overcome the effectiveness of, and neutralize, the sanitizer. The sanitizing solution must be changed as needed to minimize the accumulation of organic material and sustain proper concentration. Proper sanitizer concentration should be ensured by checking the solution periodically with an appropriate chemical test kit.
Refer to the public health reason for § 3-304.11.
Gloves used in handling ready-to-eat food are defined as a "utensil." This means that gloves used for food contact must meet the criteria listed in Parts 4-1 Materials for Construction and Repair, and 4-2 Design and Construction.
All gloves used in direct contact with food must meet FDA criteria for indirect food additives. The FDA, Office of Premarket Approval, Indirect Additives, reviews gloves submitted for food-contact use in the food industry on the basis of the glove's formulation or components.
Multiuse gloves, especially when used repeatedly and soiled, can become breeding grounds for pathogens that could be transferred to food. Soiled gloves can directly contaminate food if stored with ready-to-eat food or may indirectly contaminate food if stored with articles that will be used in contact with food.
Natural rubber latex gloves have been reported to cause allergic reactions in some individuals who wear latex gloves during food preparation, and even in individuals eating food prepared by food employees wearing latex gloves (refer to Annex 2 for this section). This information should be taken into consideration when deciding whether single-use gloves made of latex will be used during food preparation.
Slash-resistant gloves are not easily cleaned and sanitized. Their use with ready-to-eat foods could contaminate the food.
Refer to the public health reason for § 3-304.11.
Refer to the public health reason for § 3-304.11.
Pathogens can contaminate and/or grow in food that is not stored properly. Drips of condensate and drafts of unfiltered air can be sources of microbial contamination for stored food. Shoes carry contamination onto the floors of food preparation and storage areas. Even trace amounts of refuse or wastes in rooms used as toilets or for dressing, storing garbage or implements, or housing machinery can become sources of food contamination. Moist conditions in storage areas promote microbial growth.
The possibility of product contamination increases whenever food is exposed. Changing the container(s) for machine vended potentially hazardous food allows microbes that may be present an opportunity to contaminate the food. Pathogens could be present on the hands of the individual packaging the food, the equipment used, or the exterior of the original packaging. In addition, many potentially hazardous foods are vended in a hermetically sealed state to ensure product safety. Once the original seal is broken, the food is vulnerable to contamination.
Food preparation activities may expose food to an environment that may lead to the food's contamination. Just as food must be protected during storage, it must also be protected during preparation. Sources of environmental contamination may include splash from cleaning operations, drips form overhead air conditioning vents, or air from an uncontrolled atmosphere such as may be encountered when preparing food in a building that is not constructed according to Food Code requirements.
During display, food can be contaminated even when there is no direct hand contact. Many microbes can be conveyed considerable distances on air currents through fine sprays or aerosols. These may originate from people breathing or sneezing, water sprays directed at drains, or condensate from air conditioners. Even wind gusts across sewage deposits and fertilized fields have been known to contaminate food in adjacent establishments where food was unprotected.
Unpackaged condiments are exposed to contamination by consumers who could be suffering from a disease transmissible through food. Once the condiments are contaminated, subsequent consumers using the condiments may be exposed to pathogens. Condiments in individual packages are protected from consumer contamination.
On- or off-site facilities for refilling condiment dispensers must be adequately equipped to ensure that the filling operation does not introduce contaminants.
Raw foods of animal origin usually contain pathogens. In addition, these foods, if offered for consumer self-service, could cross contaminate other foods stored in the same display. Because raw foods of animal origin are assumed to be contaminated and do provide an ideal medium for the growth of pathogenic organisms, they should not be available for consumer self-service. Self-service operations of ready-to-eat foods also provide an opportunity for contamination by consumers. The risk of contamination can be reduced by supplying clean utensils and dispensers and by employee monitoring of these operations to ensure that the utensils and dispensers are properly used.
Bean sprouts that are displayed in produce areas for consumer self-service are potentially hazardous foods and appropriate refrigeration must be maintained. However, they are not considered ready-to-eat since they are intended to be washed by the consumer before consumption.
Food can serve as a means of person-to-person transmission of disease agents such as hepatitis A virus. Any unpackaged foods, even bakery goods in a bread basket that are not potentially hazardous and that have been served to a consumer, but not eaten, can become vehicles for transmitting pathogenic microorganisms from the initial consumer to the next if the food is served again.
This Code section provides a category in which to capture sources of contamination not specifically delineated in Subparts 3-301 through 306. Codes prior to 1993 had such a provision for addressing food contamination for reasons other than those elsewhere specified. Regardless of its specificity, a Code can not anticipate all the diverse means by which food can become contaminated after receipt.
Cooking, to be effective in eliminating pathogens, must be adjusted to a number of factors. These include the anticipated level of pathogenic bacteria in the raw product, the initial temperature of the food, and the food's bulk which affects the time to achieve the needed internal product temperature. Other factors to be considered include post-cooking heat rise and the time the food must be held at a specified internal temperature.
Greater numbers and varieties of pathogens generally are found on poultry than on other raw animal foods. Therefore, a higher temperature, in combination with the appropriate time is needed to cook these products.
To kill microorganisms, food must be held at a sufficient temperature for the specified time. Cooking is a scheduled process in which each of a series of continuous time/temperature combinations can be equally effective. For example, in cooking a beef roast, the microbial lethality achieved at 121 minutes after it has reached 54°C (130°F) is the same lethality attained as if it were cooked for 3 minutes after it has reached 63°C (145°F).
Cooking requirements are based in part on the biology of pathogens. The thermal destruction of a microorganism is determined by its ability to survive heat. Different species of microorganisms have different susceptibilities to heat. Also, the growing stage of a species (such as the vegetative cell of bacteria, the trophozoite of protozoa, or the larval form of worms) is less resistant than the same organism's survival form (the bacterial spore, protozoan cyst, or worm egg).
Food characteristics also affect the lethality of cooking temperatures. Heat penetrates into different foods at different rates. High fat content in food reduces the effective lethality of heat. High humidity within the cooking vessel and the moisture content of food aid thermal destruction.
Heating a large roast too quickly with a high oven temperature may char or dry the outside, creating a layer of insulation that shields the inside from efficient heat penetration. To kill all pathogens in food, cooking must bring all parts of the food up to the required temperatures for the correct length of time.
The temperature and time combination criteria specified in Part 3-4 of this Code are based on the destruction of Salmonellae. This Part includes temperature and time parameters that provide "D" values (decimal log reduction values) that may surpass 7D. For example, at 63°C(145°F), a time span of 15 seconds will provide a 3D reduction of Salmonella Enteritidis in eggs. This organism, if present in raw shell eggs, is generally found in relatively low numbers. Other foods, uncomminuted fish and meats including commercially raised game animal meat, specified as acceptable for cooking at this temperature and time parameter are expected to have a low level of internal contamination. The parameters are expected to provide destruction of the surface contaminants on these foods.
Seared Steak
The provision for allowing seared steaks was reviewed by the National Advisory Committee for Microbiological Criteria for Foods (NACMCF) and USDA. Paragraph 3-401.11(C) includes their recommendations.
USDA comments included, "For the purposes of this discussion, steak is a whole beef muscle. It does not include whole beef muscle that has been pinned, injected, or chopped and formed. It may be cut cross grain, such as sirloin, chuck, or porterhouse; or it may be cut with the grain, such as flank, skirt, or Chateaubriand. Other species, such as poultry, pork and lamb, are not included."
NACMCF comments included, "Due to the low probability of pathogenic organisms being present in or migrating from the external surface to the interior of beef muscle, cuts of intact muscle (steaks) should be safe if the external surfaces are exposed to temperatures sufficient to effect a cooked color change. In addition, the cut (exposed) surfaces must receive additional heat to effect a complete sear across the cut surfaces. Grill or char marks may be applied to the complete surface searing. The meat should be seared on both top and bottom surfaces utilizing a heating environment (e.g., grill or broiling oven) that imparts a temperature at the surface of the intact steak of at least 145°F to achieve a cooked color change on all external surfaces. The searing of all surfaces should be continuous until the desired degree of doneness and appearance are attained. This is considered a ready to eat food."
As reflected in the definition of "whole-muscle, intact beef steak," marination is a food safety concern when the fascia (exterior surface) of the steak is broken by scoring or other means which allows the marinade to penetrate, and potentially contaminate, the interior of the steak. In such cases, the Code allowance for undercooking without a consumer advisory is negated.
Pork
In pork, Trichinella spiralis, Toxoplasma gondii, and Taenia solium, parasites causing foodborne illness, are inactivated at temperatures below 145°F. Therefore, pork roasts can be cooked like beef roasts (e.g., 145°F for 3 minutes) and pork chops cooked like steaks to achieve an internal temperature of 145°F for 15 seconds.
Based on the Goodfellow and Brown study, a 5D reduction of organisms is achieved at 68°C (155°F) for 15 seconds for the following foods: ratites and injected meats and comminuted: fish, meat, game animals commercially raised for food, and game animals that come under a USDA voluntary inspection program. Ratites such as ostrich, emu, and rhea are included in this list of raw animals foods because when cooked to a temperature greater than 68°C (155°F), ratites exhibit a (metallic) "off" taste.
When USDA established the time and temperature parameters for 9 CFR 318.23 (known as the "patty rule"), the Agency based the 5D for Salmonella on extrapolations applied to the research done by Goodfellow and Brown to account for the lack of a "come up, come down" time in the thin, small mass beef patties. Consequently, there is no linear relationship between the patty rule and roast beef time and temperature parameters. The patty rule also provided for an 8D reduction in the number of E. coli. The time and temperature requirements in the Food Code for comminuted meats are comparable to the USDA requirements.
Temperature for Comminuted Meat at Less Than 1 Second
In the "Report of the Task Force on Technical Issues Arising from the National Advisory Committee for Microbiological Criteria for Foods' (NACMCF) Review of the Meat Patty Proposal" (undated), it is stated on page 7, in Option (A), that:
In November, 1997, the NACMCF Meat and Poultry Subcommittee revisited the time and temperatures for cooking hamburger and advised FDA that cooking hamburger to 158°F for less than one second is an adequate cook based on the following:
The parameters for cooking poultry, wild game animal meats, stuffed food products, etc., of 74°C(165°F) or above for 15 seconds yield greater than a 7D reduction.
The rapid increase in food temperature resulting from microwave heating does not provide the same cumulative time and temperature relationship necessary for the destruction of microorganisms as do conventional cooking methods. In order to achieve comparable lethality, the food must attain a temperature of 74°C (165°F) in all parts of the food. Since cold spots may exist in food cooking in a microwave oven, it is critical to measure the food temperature at multiple sites when the food is removed from the oven and then allow the food to stand covered for two minutes post microwave heating to allow thermal equalization and exposure. Although some microwave ovens are designed and engineered to deliver energy more evenly to the food than others, the important factor is to measure and ensure that the final temperature reaches 74°C (165°F) throughout the food.
"The factors that influence microwave thermal processes include many of the same factors that are important in conventional processes (mass of objects, shape of objects, specific heat and thermal conductivity, etc.). However, other factors are unique in affecting microwave heating, due to the nature of the electric field involved in causing molecular friction. These factors are exemplified by moisture and salt contents of foods, which play a far more important role in microwave than conventional heating." (Reference: Heddelson and Doores, see Annex 2)
Fruits and vegetables that are fresh, frozen, or canned and that are heated for hot holding need only to be cooked to the temperature required for hot holding. These foods do not require the same level of microorganism destruction as do raw animal foods since these fruits and vegetables are ready-to-eat at any temperature. Cooking to the hot holding temperature of 60°C (140°F) prevents the growth of pathogenic bacteria that may be present in or on these foods. In fact, the level of bacteria will be reduced over time at the specified hot holding temperature.
Refer to the public health reason for § 3-201.11.
Lightly cooked, raw, raw-marinated, and cold-smoked fish may be desired by consumers for taste or perceived nutritional reasons. In order to ensure destruction of parasites, fish may be frozen before service as an alternative public health control to that which is provided by adequate cooking. Candling or other visual inspection techniques are not adequate to avoid the risk of parasites from fish which have not been frozen.
In response to information provided to the FDA Office of Seafood, the Fish and Fishery Hazards and Controls Guide lists certain species of tuna as not being susceptible to parasites of concern and therefore are exempted from the freezing requirements for other fish species that are consumed raw.
Records must be maintained to verify that the critical limits required for food safety are being met. Records provide a check for both the operator and the regulator in determining that monitoring and corrective actions have taken place.
When food is held, cooled, and reheated in a food establishment, there is an increased risk from contamination caused by personnel, equipment, procedures, or other factors. If food is held at improper temperatures for enough time, pathogens have the opportunity to multiply to dangerous numbers. Proper reheating provides a major degree of assurance that pathogens will be eliminated. It is especially effective in reducing the numbers of Clostridium perfringens that may grow in meat, poultry, or gravy if these products were improperly held. Vegetative cells of C. perfringens can cause foodborne illness when they grow to high numbers. Although it takes as many as 1 million cells to cause foodborne illness, the generation time for C. perfringens is very short at temperatures just below adequate hot holding. Highly resistant C. perfringens spores will survive cooking and hot holding. If food is abused by being held below adequate hot holding temperatures, spores can germinate to become rapidly multiplying vegetative cells.
Although proper reheating will kill most organisms of concern, some toxins such as that produced by Staphylococcus aureus, cannot be inactivated through reheating of the food. It is imperative that food contamination be minimized to avoid this risk.
The potential for growth of pathogenic bacteria is greater in reheated cooked foods than in raw foods. This is because spoilage bacteria, which inhibit the growth of pathogens by competition on raw product, are killed during cooking. Subsequent recontamination will allow pathogens to grow without competition if temperature abuse occurs.
Refer also to the public health reason for § 3-401.12.
Freezing prevents microbial growth in foods, but usually does not destroy all microorganisms. Improper thawing provides an opportunity for surviving bacteria to grow to harmful numbers and/or produce toxins. If the food is then refrozen, significant numbers of bacteria and/or all preformed toxins are preserved.
Proper cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods has been consistently identified as one of the leading contributing factors to foodborne illness. During extended cooling, potentially hazardous foods are subject to the growth of a variety of pathogenic microorganisms. A longer time near ideal bacterial incubation temperatures, 21°C - 49°C (70°F - 120°F), is to be avoided. If the food is not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness.
If the cooking step prior to cooling is adequate and no recontamination occurs, all but the spore-forming organisms such as Clostridium perfringens or Bacillus cereus should be killed or inactivated. However, under poorly monitored conditions, other pathogens such as Salmonella may be reintroduced. Thus, cooling requirements have been based on growth characteristics of organisms that grow rapidly under temperature abuse conditions.
A separate method for cooling shell eggs is allowed in food establishments because of the cumulative information that has been gathered about the specific dynamics of the particular pathogen of concern in intact shell eggs.
Aside from the recognized need for an integrated approach to the cooling of eggs from farm to table, there are several germane facts that support unique provisions for cooling eggs at retail.
Federal regulations effective August 27, 1999, require shell eggs to be transported and distributed under refrigeration at an ambient temperature not to exceed 45°F. Packed shell eggs must be labeled indicating that refrigeration is required. Imported shell eggs packed for consumer use are required to include a certification that the eggs, at all times after packing, have been stored and transported at an ambient temperature of no greater than 45°F.
Shell eggs are allowed longer than 4 hours to cool to the temperature required under the Code provided they are placed immediately after receipt in refrigerated equipment that is capable of maintaining food temperatures as required by the Code. With the newly established federal requirement for eggs to be in an ambient storage and transportation temperature of 45°F, and with refrigeration of eggs at retail as described above, the overall time that eggs are stored at temperatures that allow the growth of Salmonella spp. should be shortened. Upon receiving shell eggs, food establishment operators should maximize the circulation of cooled air in refrigeration units by separating flats, cases, and multiple cartons of eggs.
Large food items, such as roasts, turkeys, and large containers of rice or refried beans, take longer to cool because of the mass and volume from which heat must be removed. By reducing the volume of the food in an individual container, the rate of cooling is dramatically increased and opportunity for pathogen growth is minimized. If the hot food container is tightly covered, the rate of heat transfer is reduced, i.e., the time required for cooling and the time the food is exposed to optimal temperatures for bacterial multiplication or toxin production are increased.
Alternatives to conventional methods include avoiding the need to cool larger masses by preparing smaller batches closer to periods of service or chilling while stirring hot food in containers within an ice water bath. Commercial refrigeration equipment is designed to hold cold food temperatures, not cool large masses of food. Rapid chilling equipment is designed to cool the food to acceptable temperatures quickly by using very low temperatures and high rates of air circulation.
Bacterial growth and/or toxin production can occur if potentially hazardous food remains in the temperature "Danger Zone" of 5°C to 60°C (41°F to 140°F) too long. Up to a point, the rate of growth increases with an increase in temperature within this zone. Beyond the upper limit of the optimal temperature range for a particular organism, the rate of growth decreases. Operations requiring heating or cooling of food should be performed as rapidly as possible to avoid the possibility of bacterial growth.
Refer to Annex 7, Chart 3.
Refrigeration prevents food from becoming a hazard by significantly slowing the growth of most microbes. The growth of some bacteria, such as Listeria monocytogenes, is significantly slowed but not stopped by refrigeration. Over a period of time, this and like organisms may increase to hazardous levels in ready-to-eat foods.
The date by which the food must be consumed takes into consideration the differences in growth of Listeria monocytogenes at 5°C (41°F) and 7°C (45°F). Based on a predictive growth curve modeling program for Listeria monocytogenes, ready-to-eat, potentially hazardous food may be kept at 5°C (41°F) a total of 7 days or at 7°C (45°F) a total of 4 days. Therefore, the period of time allowed before consumption is shortened for food in refrigerators incapable of maintaining food at 5°C (41°F) but capable of maintaining it at 7°C (45°F) or below. Food which is prepared and held, or prepared, frozen, and thawed must be controlled by date marking to ensure its safety based on the total amount of time it was held at refrigeration temperature, and the opportunity for Listeria monocytogenes to multiply, before freezing and after thawing. Potentially hazardous refrigerated foods must be consumed or discarded by the expiration date.
Potentially hazardous food may be held without temperature control for short time periods not exceeding four hours because there will be no significant growth or toxin production possible in that limited time.
Recipes in which more than one egg is combined carry an increased risk of illness and possible serious consequences for certain people. It is due to this increased risk, and documented occurrences of foodborne illness and death among highly susceptible populations from temperature-abused raw shell eggs contaminated with Salmonella Enteritidis, that the use of time as a public health control in institutional settings is not allowed.
Specific food processes that require a variance have historically resulted in more foodborne illness than standard processes. They present a significant health risk if not conducted under strict operational procedures. These types of operations may require the person in charge and food employees to use specialized equipment and demonstrate specific competencies. The variance requirement is designed to ensure that the proposed method of operation is carried out safely.
A Hazard Analysis Critical Control Point (HACCP) plan is necessary when using reduced oxygen packaging (ROP) processing procedures. A reduced oxygen packaged food that has at least two barriers to the growth and toxin production of C. botulinum may be packaged in accordance with the provisions of a HACCP plan. The FDA recommends two barriers be used to ensure the safety of foods when C. botulinum is a known hazard in the final packaged form.
An ROP food that has only one barrier to the growth and toxin production of C. botulinum may be produced only if the food establishment obtains a variance and produces the food in accordance with the provisions of a HACCP plan. An example of a single barrier would be a food with a natural pH of 4.6 or less. Regardless of whether a variance is required, the primary safety barrier that must be monitored for control is adequate refrigeration. Variance requests related to packaging food using reduced levels of oxygen and having only one barrier to control the growth of C. botulinum must be considered with particular caution and scrutiny.
This section does not apply to low acid canned foods produced under 21 CFR Part 108 (Emergency Permit Control) and 21 CFR Part 113 (Thermally Processed Low-Acid Foods) or 21 CFR Part 114 (Acidified Foods) because C. botulinum is not a hazard in the final packaged form.
FDA strongly recommends that garlic garlic-in-oil mixtures that are produced in a food establishment have two barriers in place. It is not possible to acidify the oil although the crushed cloves can be acidified. An example of two effective barriers is acidification of crushed garlic cloves and refrigeration of the garlic-in-oil mixture. Acidification means a finished equilibrium pH of 4.6 or less. Garlic-in-water mixtures can be acidified and refrigerated, using a HACCP plan without the necessity of a variance.
Unfrozen raw fish is specifically excluded from ROP because of this product's natural association with Clostridium botulinum, Type E, which grows at or above 3°C (38°F). To be adequate, a HACCP plan must identify critical control points that are to be monitored to minimize microbial growth during product packaging and storage.
Earlier FDA guidance regarding the reduced oxygen packaging of cured meat products specified a combination of nitrites, nitrates, and salt that at the time of processing consisted of a concentration of at least 120 mg/L of sodium nitrite and a minimum brine concentration of 3.50%. The Code reflects the fact that various substances, combinations of substances, and resultant concentrations are allowed in CFR administered by USDA. The Code provision also includes the requirement for cured poultry products to meet the CFR.
Shelf-life must be determined considering holding temperatures because some pathogens, including Listeria monocytogenes, may be a hazard at refrigeration temperatures. Safe food that remains frozen from the time it is packaged until prepared for service is considered adequately protected.
The identity of a food in terms of origin and composition is important for instances when a food may be implicated in a foodborne illness and for nutritional information requirements. Ingredient information is needed by consumers who have allergies to certain food or ingredients. The appearance of a food should not be altered or disguised because it is a cue to the consumer of the food's identity and condition.
Recent illnesses and deaths from Escherichia coli O157:H7 have occurred across the United States as a result of people eating hamburgers that were contaminated and then undercooked. USDA issued final rules on August 8, 1994 requiring all raw meat or poultry products have a safe-handling label or sticker or be accompanied by a leaflet that contains information on proper handling and cooking procedures.
Certain requirements in the CFR relating to aspects of nutrition labeling became effective in May, 1997. The following attempts to provide guidance regarding those requirements and exemptions as they relate to the retail environment and to alert regulators to authority that has been given to them by the Nutrition Labeling and Education Act (NLEA) of 1990. The statute and the CFR should be reviewed to ensure a comprehensive understanding of the labeling requirements.
(A) Foods packaged in a food establishment if:
(1) The food establishment has total annual sales to consumers of no more than $500,000 (or no more than $50,000 in food sales alone), and
(2) The label of the food does not bear a reference to the manufacturer or processor other than the food establishment;
(B) Low-volume food products if:
(1) The annual sales are less than 100,000 units for which a notification claiming exemption has been filed with FDA's Office of Food Labeling by a small business with less than 100 full-time equivalent employees, or
(2) The annual sales are less than 10,000 units by a small business with less than 10 full-time equivalent employees;
(C) Foods served in food establishments with facilities for immediate consumption such as restaurants, cafeterias, and mobile food establishments, and foods sold only in those establishments;
(D) Foods similar to those specified in the perceding bullet but that are sold by food establishments without facilities for immediate consumption such as bakeries and grocery stores if the food is:
(1) Ready-to-eat but not necessarily for immediate consumption,
(2) Prepared primar