Applicability and Terms Defined

   1-201.10   Statement of Application and Listing of Terms.

(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 Standards for Accreditation of Food Protection Manager Certification Programs available from the Conference for Food Protection, 1085 Denio Avenue, Gilroy, CA 95020-9206. 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 19^th 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.

Responsibility

   2-101.11   Assignment.*

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.

Knowledge

   2-102.11   Demonstration.*

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 Food Code does not require reporting of uninfected cuts or reporting of covered, protected infected cuts/lesions/boils since it requires no bare hand contact with ready-to-eat food.

Status of "Universal Acceptance" of Food Protection Manager Certificates

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 the standards for test development and test administration. Information regarding this CFP Food Protection Manager Certification Examination recognition process can be obtained by accessing the Conference for Food Protection web site at http://www.foodprotect.org.

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. It is anticipated that this comparable accreditation process will be submitted for deliberation at the 2002 Conference meeting.

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.

Duties

   2-103.11   Person in Charge.

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.

Subparagraph (L) "Employees are properly trained in food safety as it relates to their assigned duties" allows industry to develop and implement operational-specific training programs for food employees. It is not intended to require that all food employees pass a test that is part of an accredited program.

Disease or Medical Condition

   2-201.11   Responsibility of the Person in Charge to Require Reporting by Food Employees and Applicants.*

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, the Centers for Disease Control and Prevention (CDC) published in the Federal Register on September 27, 2000, (Volume 65, Number 188) 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 and pathogens occasionally transmitted by infected persons who handle food.

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. The Lists below include all Shiga toxin-producing E. coli likely to occur in foods in the United States.

KEY: D = Diarrhea V = Vomiting S = Sore throat with fever F = Fever J = Jaundice

The Food Code definition of Shiga toxin-producing Escherichia coli (STEC) covers all STEC identified in clinical laboratories by O157 and H7 serological tests, or by Shiga toxin tests.

The definition includes all STEC, including those that are not specifically implicated in hemorrhagic colitis (i.e., bloody diarrhea). Only a subset of STEC (>100 STEC strains cause the vast majority of human STEC diarrhea) are traditionally classified as "enterohemorrhagic", and those serotypes that are considered "enterohemorrhagic", including E. coli O157:H7, do not actually cause a hemorrhagic form of colitis in a substantial percentage of cases. Virtually all O157:H7 strains produce Shiga toxin, so are pathogens. Many O157:NM or O157:H- also produce Shiga toxin, but some don't, so testing for shiga toxin is needed to be sure that they are STEC.

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., Shiga toxin-producing Escherichia coli, 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.

The following information, taken from Control of Communicable Diseases Manual, is provided regarding the period of communicability for the four pathogens of concern and the application of that information to employees likely to be shedding certain pathogens:

Salmonella Typhi -- As long as the bacilli appear in the excreta, usually from the first week throughout the convalescence; variable thereafter (commonly 1-2 weeks for paratyphoid). About 10% of untreated typhoid fever patients will discharge bacilli for 3 months after onset of symptoms, and 2%-5% become permanent carriers; considerable fewer persons affected with paratyphoid organisms may become permanent gallbladder carriers.

Shigella spp. -- During acute infection and until the infectious agent is no longer present in feces, usually within 4 weeks after illness. Asymptomatic carriers may transmit infection; rarely, the carrier state may persist for months or longer. Appropriate antimicrobial treatment usually reduces duration of carriage to a few days.

Shiga toxin-producing serotypes of Escherichia coli, including E. coli O157:H7 -- The duration of excretion of the pathogen, which is typically for a week or less in adults but 3 weeks in one third of children. Prolonged carriage is uncommon.

Hepatitis A -- Evidence indicates maximum infectivity during the latter half of the incubation period, continuing for a few days after onset of jaundice, although prolonged viral excretion (up to 6 months) has been documented in infants born prematurely.   The infectious agent is found in feces, reaching peak levels the week or two before onset of symptoms, and diminishing rapidly after liver dysfunction or symptoms appear, which is concurrent with the appearance of circulating antibodies to HAV.

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.

If an employee has an infected cut and bandages it, plus puts on a glove, the employee does not have to report the infected cut to the person in charge. However, if the employee does not bandage it, reporting is required.

   2-201.12   Exclusions and Restrictions.*

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., Shiga toxin-producing Escherichia coli, 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 Food Code does not require restriction of a food employee with an unprotected, uninfected cut, or a food employee with a covered, protected infected cut/lesion/boil since it requires no bare hand contact with ready-to-eat food.

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:

1. Because hepatitis A virus infection can occur without clinical illness (i.e., without symptoms), or because a person may shed hepatitis A virus in the stool for up to a week before becoming symptomatic, it is possible that a person unknowingly may have been exposed to an asymptomatic hepatitis A virus shedder or to an infected person who is in the incubation stage. No restriction/exclusion routinely occurs under these -- presumably much more common -- circumstances.

2. Even though the asymptomatic food employee may be infected with hepatitis A virus and may in fact be shedding virus in the stool, foodborne transmission of hepatitis A virus is unlikely if the employee practices good personal hygiene, such as washing hands after going to the bathroom.

3. Exclusions from work for prolonged periods of time may involve economic hardship for the food employee excluded.

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:

1. Clarify the type of contact the individual had with another person diagnosed with hepatitis A virus infection. Keep in mind that the closer the contact (i.e., living in the same household as the infected person), the more likely it is that a susceptible person may become infected.
    
2. What job does the food employee perform at the food establishment, e.g., is the employee involved in food preparation?
    
3. When did the employee begin work at the establishment?
    
4. What level of personal hygiene does the individual exhibit? For example, does the individual adhere to the handwashing requirements specified in the Code?
    
5. Has the individual suffered from hepatitis A in the past? If the answer to this question is yes, was blood testing done? If the individual did have hepatitis A in the past, the individual is immune from re-infection.
    
6. In terms of the current high-risk condition, has the individual received immune globin (IG)? When?

In addition, upon being notified of the high-risk condition, the person in charge should immediately:

1. Discuss the traditional modes of transmission of hepatitis A virus infection with the food employee involved.
    
2. Advise the food employee to observe good hygienic practices both at home and at work. This includes a discussion of proper handwashing, as described in the Code, after going to the bathroom, changing diapers, or handling stool-soiled material.
    
3. Review the symptoms listed in the Code that are caused by hepatitis A infection.
    
4. Remind the employee of the employee's responsibility as specified in the Code to inform the person in charge immediately upon the onset of any of the symptoms listed in the Code.
    
5. In light of the high infectivity of hepatitis A, ensure that the employee stops work immediately if any of the symptoms described in the Code develop and reports to the person in charge.

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.

A restricted food employee may work in an area of the food establishment where there is wrapped food, wrapped single-service or single-use articles, or soiled food equipment or utensils. Examples of activities that a restricted person might do include working at the cash register, seating patrons, bussing tables, stocking canned or other packaged foods, or working in a non-food cleaning or maintenance capacity consistent with the criteria in the definition of the term "restricted." A food employee who is restricted from working in one food establishment may not work in an unrestricted capacity in another food establishment, but could work unrestricted in another retail store that is not a food establishment. A restricted food employee may enter a food establishment as a consumer or the same as any other member of the general public.

An excluded individual may not work as a food employee on the premises of any food establishment. In a facility that has different departments, such as a department store, school, or health care facility, the regulatory authority, in concert with other infection control authorities, may consider allowing an excluded food employee to work in an area or department that is separate and segregated from the food preparation, service, and storage areas, and the food equipment and utensil areas, such as the soiled linen/laundry area or exterior maintenance. An excluded person may enter the food establishment as a customer or the same as any member of the general public.

   2-201.13   Removal of Exclusions and Restrictions.

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.

• Outbreaks of foodborne illness involving Salmonella Typhi have been traced to asymptomatic food employees who have transmitted the pathogen to food, causing illness.
   
• There is some epidemiological evidence of transmission of food via food employees infected with Shigella spp.
   
• Healthy consumers are at risk due to a low infectious dose of Shigella spp.
   
• Despite lacking epidemiological evidence of transmission of food via food employees infected with Shiga toxin-producing Escherichia coli, the documented ease of transmitting it from person-to-person in a day care setting, suggests a low infectious dose and the potential for the organism to be transmitted through food.
   
• The severity and consequences of one of the illnesses, Hemolytic Uremic Syndrome (HUS), associated with Shiga toxin-producing Escherichia coli warrant the institution of disease interventions.
   
• Restriction in a food establishment that does not serve a highly susceptible population affords protection for the general population and the immune-suppressed subset of the general population.
   

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 Shiga toxin-producing Escherichia coli; or
   
• (C) Had a recent illness caused by S. Typhi, Shigella spp., or Shiga toxin-producing Escherichia coli. 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.

   2-201.14   Responsibility of a Food Employee or an Applicant to Report to the Person in Charge.*

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.

   2-201.15   Reporting by the Person in Charge.*

Notification of the regulatory authority by the person in charge that an employee is suffering illness caused by Salmonella Typhi, Shigella spp., Shiga toxin-producing Escherichia coli, 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.

Hands and Arms

   2-301.11   Clean Condition.*

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.

   2-301.12   Cleaning Procedure.*

Handwashing is a critical factor in reducing fecal-oral pathogens that can be transmitted from hands to ready-to-eat food as well as other pathogens that can be transmitted via cross contamination from raw foods to ready-to-eat foods. Many employees fail to wash their hands as often as necessary and even those who do may use flawed technique.

In the case of a food worker with one hand or a hand-like prosthesis, the EEOC has agreed that this requirement for thorough handwashing can be met through reasonable accommodation in accordance with the Americans with Disabilities Act. Devices are available which can be attached to a lavatory to enable the food worker with one hand to adequately generate the necessary friction to achieve the intent of this requirement without sacrificing public health concerns.

The greatest concentration of microbes exists around and under the fingernails of the hands. The area under the fingernails, known as the "subungal space", has by far the largest concentration of microbes on the hand and this is also the most difficult area of the hand to decontaminate.

There are two different types of microbes on the hands, transient and resident microbes. Transient microbes consist of contaminating pathogens which are loosely attached to the skin surface, do not survive nor multiply, and a moderate number of organisms can be removed with adequate handwashing. Resident microbes consist of a relatively stable population that survive and multiply on the skin, and are not easily washed off the hands. Resident microbes on the hands are usually not a concern for potential contamination in food service.

All aspects of proper handwashing are important in reducing microbial transients on the hands. However, friction and water have been found to play the most important role. This is why the amount of time spent scrubbing the hands is critical in proper handwashing. 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 transient microorganisms on the hands.

Research has shown a minimum 10-15 second scrub is necessary to remove transient pathogens from the hands, and when an antimicrobial soap is used, a minimum of 15 seconds is required.

Every stage in handwashing is equally important and has an additive effect in transient microbial reduction. Therefore, effective handwashing must include scrubbing, rinsing, and drying the hands. When done properly, each stage of handwashing further decreases the transient microbial load on the hands.

Handwashing done properly can result in a 2-3 logarithmic reduction in transient bacteria and a 2-log reduction in transient viruses and protozoa. With heavy contamination of transient microbial pathogens, (i.e. > 10⁴ microbes, as found on hands contaminated with bodily wastes and infected bodily fluids) handwashing may be ineffective in completely decontaminating the hands. Therefore, a further intervention such as a barrier between hands and ready-to-eat food is necessary.

   2-301.13   Special Handwash Procedures.*

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.

   2-301.14   When to Wash.*

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.

   2-301.15   Where to Wash.

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.

   2-301.16   Hand Sanitizers.

(See Supplement)

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:

1. A hand sanitizer may be approved by FDA under a new drug application based on data showing safety and effectiveness and may be listed in the publication Approved Drug Products with Therapeutic Equivalence Evaluations. Also known as the "Orange Book," this document provides "product-specifiic" listings rather than listings by compound. It is published annually with monthly supplements. These publications are available on the Internet via the FDA Web Site and Center for Drug Evaluation and Research Home Page, from the Superintendent of Documents/Government Printing Office, and from the National Technical Information Service. However, as of the end of 1998, no hand sanitizers are listed in this publication since no new drug applications have been submitted and approved for these products.
    
2. A hand sanitizer active ingredient may be identified by FDA in the monograph for OTC (over-the-counter) Health-Care Antiseptic Drug Products under the antiseptic handwash category. Since hand sanitizing products are intended and labeled for topical antimicrobial use by food employees in the prevention of disease in humans, these products are "drugs" under the Federal Food, Drug, and Cosmetic Act ¶ 201(g). As drugs, hand sanitizers and dips must be manufactured by an establishment that is duly registered with the FDA as a drug manufacturer; their manufacturing, processing, packaging, and labeling must be performed in conformance with drug Good Manufacturing Practices (GMP's); and the product must be listed with FDA as a drug product.
    
   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.
    
   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.

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:

1. A substance may be exempted from the requirement of being listed in the federal food additive regulations as specified in 21 CFR 170.39 Threshold of regulation for substances used in food-contact articles. A review by FDA's Center for Food Safety and Applied Nutrition is required for such an exemption to be issued. The Center's Indirect Additives Group has exempted ethyl alcohol and isopropyl alcohol from the requirement of being listed in the federal food additive regulations. Therefore, there is no food additive prohibition against using these substances as components of an instant hand sanitizer.
    
2. A substance may be regulated for the intended use as a food additive as specified in 21 CFR 178 (579 KB) - Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers, and listed thereunder with conditions of safe use. However, as of 1998, no petitions have been received for the review and approval of substances for use as hand sanitizers, and therefore none are listed.
    
3. A substance may be "generally recognized as safe (GRAS)" for the intended use in contact with food within the meaning of the Federal Food, Drug, and Cosmetic Act § 201(s). Substances affirmed by FDA to be GRAS are listed in one of the following: 21 CFR 182 - Substances Generally Recognized as Safe, 21 CFR 184 (545 KB) - Direct Food Substances Affirmed as Generally Recognized as Safe, or 21 CFR 186 - Indirect Food Substances Affirmed as Generally Recognized as Safe. The law also provides for independent GRAS determinations.
    
   The Indirect Additive Group 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 Group, HFS-215, Office of Food Additive Safety, 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.

Fingernails

   2-302.11   Maintenance.

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.

Jewelry

   2-303.11   Prohibition.

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.

The term "jewelry" generally refers to the ornaments worn for personal adornment and medical alert bracelets do not fit this definition. However, the wearing of such bracelets carries the same potential for transmitting disease-causing organisms to food. In the case of a food worker who wears a medical information or medical alert bracelet, the EEOC has agreed that this requirement can be met through reasonable accommodation in accordance with the Americans with Disabilities Act by the person in charge and the employee working out acceptable alternatives to the bracelet worn at the wrist. An example would be wearing the bracelet high on the arm or secured in a manner that does not pose a risk to the food but provides emergency medical information if it is needed.

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.

Outer Clothing

   2-304.11   Clean Condition.

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 Contamination Prevention

   2-401.11   Eating, Drinking, or Using Tobacco.*

Proper hygienic practices must be followed by food employees in performing assigned duties to ensure the safety of the food, prevent the introduction of foreign objects into the food, and minimize the possibility of transmitting disease through food. Smoking or eating by employees in food preparation areas is prohibited because of the potential that the hands, food, and food-contact surfaces may become contaminated. Insanitary personal practices such as scratching the head, placing the fingers in or about the mouth or nose, and indiscriminate and uncovered sneezing or coughing may result in food contamination. Poor hygienic practices by employees may also adversely affect consumer confidence 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.

   2-401.12   Discharges from the Eyes, Nose, and Mouth.*

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.

Hair Restraints

   2-402.11   Effectiveness.

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.

  Animals

   2-403.11   Handling Prohibition.*

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.

Condition

   3-101.11   Safe, Unadulterated, and Honestly Presented.*

Sources

   3-201.11   Compliance with Food Law.*

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 consumers should exercise vigilance in controlling the conditions to which foods are subjected and be alert to signs of abuse. FDA considers food in hermetically sealed containers that are swelled or leaking to be adulterated and actionable under the Federal Food, Drug, and Cosmetic Act. Depending on the circumstances, rusted and pitted or dented cans may also present a serious potential hazard.

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

Sources of molluscan shellfish are a particular concern because shellfish are frequently consumed raw or in an undercooked state and thus receive neither heat 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) (689 KB). 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 Raw Shell Eggs

The Food and Drug Administration is revising its food labeling regulations to require a safe handling statement on cartons of shell eggs that have not been treated to destroy Salmonellae organisms. The labeling regulation becomes effective September 4, 2001.

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.

   3-201.12   Food in a Hermetically Sealed Container.*

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

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

   3-201.13   Fluid Milk and Milk Products.*

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

   3-201.14   Fish.*

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

The seafood implicated in histamine poisoning are the scombroid toxin-forming species, defined in 21 CFR 123.3(m) as meaning bluefish, mahi-mahi, tuna, and other species, whether or not in the family 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.

   3-201.15   Molluscan Shellfish.*

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

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

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

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

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

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

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

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

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

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

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

   3-201.16   Wild Mushrooms.*

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

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

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

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

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

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

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

Additional information can be found on the California Poison Control web site: http://www.calpoison.org/public/mushrooms.html.

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

   3-201.17   Game Animals.*

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

Specifications for Receiving

   3-202.11   Temperature.*

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

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

   3-202.12   Additives.*

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

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

   3-202.13   Shell Eggs.*

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

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

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

Amended federal regulations 21 CFR Part 16, Administrative practice and procedure; 21 CFR Part 101 (689 KB) Labeling, Nutrition, Reporting and Recordkeeping requirements; and 21 CFR Part 115 Eggs, Refrigeration issued on December 5, 2000. These regulations require that shell egg cartons bear safe handling instructions and further requires that eggs be placed under refrigeration at 45°F or lower upon delivery at retail establishments. See Federal Register: (Volume 65, Number 234), Pages 76091-76114. The labeling rule is effective September 4, 2001, and the refrigeration rule is effective June 4, 2001. This rule is one part of the larger Egg Safety Action Plan, a farm-to-table approach for ensuring the safety of our nation's egg supply, which was announced by the President on December 11, 1999. The Plan, a joint effort by the FDA and the USDA, seeks to reduce by 50 percent the number of Salmonella Enteritidis, illnesses attributed to contaminated eggs by 2005 and eliminate egg-associated Salmonella Enteritidis illnesses by 2010.

   3-202.14   Eggs and Milk Products, Pasteurized.*

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

   3-202.15   Package Integrity.*

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

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

   3-202.16   Ice.*

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

   3-202.17   Shucked Shellfish, Packaging and Identification.

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

   3-202.18   Shellstock Identification.*

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

   3-202.19   Shellstock, Condition.

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

   3-202.110   Juice Treated.

Refer to public health reason for § 3-801.11.

Original Containers and Records

   3-203.11   Molluscan Shellfish, Original Container.

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

   3-203.12   Shellstock, Maintaining Identification.*

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:

Preventing Contamination by Employees

   3-301.11   Preventing Contamination from Hands.*

(See Supplement)

In November, 1999, the National Advisory Committee for Microbiological Criteria for Foods (NACMCF), concluded that bare hand contact with ready-to-eat foods can contribute to the transmission of foodborne illness and agreed that the transmission could be interrupted. The NACMCF recommended exclusion/restriction of ill food workers, as the first preventative strategy and recognized that this intervention has limitations, such as trying to identify and manage asymptomatic food workers. When the FDA reviewed and analyzed epidemiological data on foodborne illness outbreaks caused by fecal-oral pathogens, 93% of the foodborne illnesses reported were caused by ill food workers preparing food. This finding illustrates the problem caused by ill food workers who continue to prepare food. This is a problem which is exacerbated by an increasing global market place, a tight labor market and lack of knowledge and understanding of food safety among food workers, and the economic need for food workers to work even when ill.

Depending on the microbial contamination level on the hands, handwashing with plain soap and water, as specified in the Food Code, may not be an adequate intervention to prevent the transmission of pathogenic microbes to ready-to-eat foods via hand contact with ready-to-eat foods. Handwashing as specified in the Food Code will reduce microbial contamination of the hands by 2-3-logs.

Food workers infected with fecal-oral pathogens can shed viral and protozoan pathogens in the feces at levels up to 10⁸ viral particles or oocysts per gram of feces. Having a high potential contamination level on the hands combined with a very low infectious dose necessary to cause infection are the reasons that FDA believes that handwashing alone is not an effective single barrier in the transmission of these fecal-oral pathogens. The infective dose for Giardia and Cryptosporidium is believed to be as low as 1-10 oocysts, and as few as 10 virus particles can infect an individual with hepatitis A. The infective dose for Norwalk virus is also believed to be very small.

The CDC now estimates that Norwalk-like viruses are the leading cause of foodborne illness in the United States. The CDC has also reported that hands are the most important means by which enteric viruses are transmitted. Further, contamination of food by an infected food worker is the most common mode of transmission of hepatitis A in foodborne disease outbreaks. Research has shown the viral transfer rate from contaminated hands to ready-to-eat food to be about 10% and that proper handwashing will significantly reduce the chance of transmitting pathogenic viruses. However, with heavy initial contamination of the hands, especially in the subungal space of the fingers, a basic 2-3 log reduction handwash procedure may not be adequate to prevent the transmission of viral foodborne illness.

The three interdependent critical factors in reducing foodborne illness transmitted through the fecal-oral route, identified by the NACMCF, include exclusion/restriction of ill food workers; proper handwashing; and no bare hand contact with ready-to-eat foods. Each of these factors is inadequate when utilized independently and may not be effective. However, when all three factors are combined and utilized properly, the transmission of fecal-oral pathogens can be controlled.

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.

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.

¹ Based on CDC Summary Surveillance for Foodborne-Disease Outbreaks - United States, 1988-1992 and New York State Department of Health data 1980-1991 published: Weingold, Guzewich, Fudala, 1994, Use of Foodborne Disease Data for HACCP Risk Assessment. J. Food Prot. 53: 820-830.

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:

• (A) Demonstration of Knowledge - specifically ¶¶ 2-102.11(A), (B), (C), and (H);
   
• (B) Duties of the Person in Charge - specifically ¶ 2-103.11(D);
   
• (C) Employee Health regarding:
   
  • (1) Reporting of diseases and medical conditions, and
     
  • (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:

• (A) Why the operator of the food establishment is unable to comply with the Code requirement in ¶ 3-301.11(B);
   
• (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:
   
  • (1) The public health hazard associated with bare-hand contact specific to the food establishment operation is identified and understood. The regulatory authority needs assurance that the permit holder recognizes that the hazard being addressed is the possible contamination of ready-to-eat food by viral and parasitic as well as bacterial pathogens that are transferred from employees' hands.
     
  • (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.
     
    • For example, identifying the specific type of food to be prepared, such as tacos, and the specific location, such as a situation where a food employee is assigned solely to the designated taco work station. The work station is located immediately adjacent to the taco assembly unit and the employee will be preparing only the specified ready-to-eat food using bare hands.
       
    • 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:

• (A) Vaccination against hepatitis A for food employees including initial and booster shots or medical evidence that a food employee has had a previous illness from hepatitis A virus;
   
• (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.

Preventing Food and Ingredient Contamination

   3-302.11   Packaged and Unpackaged Food - Protection Separation, Packaging, and Segregation.*

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.

   3-302.12   Food Storage Containers, Identified with Common Name of Food.

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.

   3-302.13   Pasteurized Eggs, Substitute for Raw Shell Eggs for Certain Recipes.*

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.

   3-302.14   Protection from Unapproved Additives.*

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.

   3-302.15   Washing Fruits and Vegetables

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.

Preventing Contamination from Ice Used as a Coolant

   3-303.11   Ice Used as Exterior Coolant, Prohibited as Ingredient.

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.

   3-303.12   Storage or Display of Food in Contact with Ice and Water.

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.

Preventing Contamination From Equipment, Utensils, and Linens

   3-304.11   Food Contact with Equipment and Utensils.*

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.

The Food Code defines gloves as a "utensil" and therefore gloves must meet the applicable requirements related to utensil construction, cleaning, and storage.

   3-304.12   In-Use Utensils, Between-Use Storage.

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.

A food utensil should be designed and used to prevent bare hand contact with ready-to-eat food or to minimize contact with food that is not in a ready-to-eat form. On-site evaluations can be made to determine if a utensil is improperly designed for the task or whether a food employee is misusing an appropriately designed utensil.

A food utensil should be designed and used to prevent bare hand contact with ready-to-eat food or to minimize contact with food that is not in a ready-to-eat form. On-site evaluations can be made to determine if a utensil is improperly designed for the task or whether a food employee is misusing an appropriately designed utensil.

   3-304.13   Linens and Napkins, Use Limitation.

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.

   3-304.14   Wiping Cloths, Use Limitation.

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.

   3-304.15   Gloves, Use Limitation.

Refer to the public health reason for § 3-304.11.

Gloves used in touching ready-to-eat food are defined as a "utensil" and must meet the applicable requirements related to utensil construction, good repair, cleaning, and storage.

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. Multiuse gloves must be washed, rinsed, and sanitized between activities that contaminate the gloves. Hands must be washed before donning gloves. Gloves must be discarded when soil or other contaminants enter the inside of the glove.

Slash-resistant gloves are not easily cleaned and sanitized. Their use with ready-to-eat foods could contaminate the food.

Natural Latex Rubber (NRL) Gloves

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, 3-304.15). This information should be taken into consideration when deciding whether single-use gloves made of latex will be used during food preparation.

Although many allergic reactions occur as a result of occupational exposure, CFSAN is actively reviewing its current policy on the use of disposable NLR gloves in food operations in light of the possible transmission of the latex protein via food. To gain additional information regarding allergic reactions allegedly due to the ingestion of food contaminated by NRL in retail settings, CFSAN has been collecting reports of such reactions from consumers who have contacted the Agency. Several offices within CFSAN will continue to collaborate in reviewing incoming data. The results of these activities and other related efforts will be used to determine if policy changes regarding the use of latex in food operations, based on food safety considerations, are warranted.

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.

FDA regulates NRL gloves used for medical purposes only.

FDA is aware of the following information related to occupational hazards (not food safety hazards) associated with the use of NRL gloves:

• The National Institute for Occupational Safety and Health (NIOSH) published a 1997 Alert titled "Preventing Allergic Reactions to Natural Rubber Latex in the Workplace" (NIOSH publication number 97-135) which is found at http://www.cdc.gov/niosh/latexalt.html.
   
• The American College of Allergy, Asthma and Immunology (ACAAI) and the American Academy of Allergy Asthma and Immunology (AAAAI) issued a joint statement discouraging the routine use of NRL gloves by food handlers. (1997) http://allergy.mcg.edu/physicians/joint.html
   
  • The AAAAI provides information on latex allergies on the web at http://www.aaaai.org/patients/resources/fastfacts/latex.stm
     
  • The ACAAI provides information on latex allergies on the web at http://allergy.mcg.edu/physicians/ltxhome.html
     
• An OSHA Technical Information Bulletin recommends reducing allergy potential by reducing unnecessary exposure to NRL. Stating "Food service workers ... do not need to use NRL gloves for food handling..." (1999) http://www.osha-slc.gov/dts/tib/tib_data/tib19990412.html
  

OSHA addresses gloves in the following federal regulation, which can be found at
http://www.osha-slc.gov/OshStd_data/1910_0138.html:

• OSHA Regulations (Standards - 29 CFR)
  Standard Number: 1910.138
  Standard Title: Hand Protection.
  SubPart Number: I
  SubPart Title: Personal Protective Equipment
   
• (a) General requirements. Employers shall select and require employees to use appropriate hand protection when employees' hands are exposed to hazards such as those from skin absorption of harmful substances; severe cuts or lacerations; severe abrasions; punctures; chemical burns; thermal burns; and harmful temperature extremes.
   
• (b) Selection. Employers shall base the selection of the appropriate hand protection on an evaluation of the performance characteristics of the hand protection relative to the task(s) to be performed, conditions present, duration of use, and the hazards and potential hazards identified.

For further information on the OSHA requirements, see [59 FR 16362, April 6, 1994].

   3-304.16   Using Clean Tableware for Second Portions and Refills.

Refer to the public health reason for § 3-304.11.

   3-304.17   Refilling Returnables.

Refer to the public health reason for § 3-304.11.

Preventing Contamination from the Premises

   3-305.11   Food Storage.

   3-305.12   Food Storage, Prohibited Areas.

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.

   3-305.13   Vended Potentially Hazardous Food, Original Container.

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.

   3-305.14   Food Preparation.

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 from 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.

Preventing Contamination by Consumers

   3-306.11   Food Display.

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.

   3-306.12   Condiments, Protection.

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.

   3-306.13   Consumer Self-Service Operations.*

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.

   3-306.14   Returned Food and Reservice or Sale.*

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.

Preventing Contamination from Other Sources

   3-307.11   Miscellaneous Sources of Contamination.

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

   3-401.11  Raw Animal Foods.*

(See Supplement)

   3-401.12   Microwave Cooking.*

   3-401.13   Plant Food Cooking for Hot Holding.

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 112 minutes after it has reached 54.4°C (130°F) is the same lethality attained as if it were cooked for 4 minutes after it has reached 62.8°C (145°F). The microbial lethality using these criteria will provide a 6.5-log₁₀ reduction of Salmonella.

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 do