U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
2001 Food Code

 

Supplement to the
2001 Food Code
August 29, 2003

IMPORTANT - Save this Supplement. It is intended to keep the 2001 Food Code up to date. Changes, additions, deletions, and format modifications listed herein constitute revisions to the 2001 Food Code effective upon issuance.

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.

For public sale by:

U.S. Department of Commerce
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National Technical Information Service
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(refer to report number PB2003-106843)

Introduction

The Food and Drug Administration (FDA) is pleased to issue this Supplement to the 2001 Food Code (hereafter referred to as Supplement). This Supplement updates the 2001 Food Code to address several recommendations made by the 2002 Conference for Food Protection (CFP) with which the FDA, Centers for Disease Control and Prevention (CDC), and United States Department of Agriculture (USDA) concur. The changes contained in this Supplement reflect the current science and emerging food safety issues, and imminent health hazards related to food safety.

From 1993 through 2001, the complete Food Code has been issued every two years. With the support of the Conference for Food Protection, FDA has decided to move to a four-year interval between complete Food Code revisions. The next complete revision of the Food Code will be published in 2005. Until that time, this Supplement allows several changes upon which there is substantial concurrence among the Federal Agencies and the other stakeholders to be incorporated into the Food Code. The Supplement ensures that the most current food safety provisions are available to agencies planning to initiate rule-making activities prior to 2005. This Supplement provides other users of the Food Code, such as educators, trainers, and the food service, retail food, and vending industries, with up-to-date information of how to best mitigate risk factors that contribute to foodborne illness.

While the recommendations of the 2002 Conference for Food Protection meeting provide the basis for the Food Code changes contained in this Supplement, not all recommendations of the 2002 CFP meeting were incorporated. Some recommendations require further consideration or research by one or more of the Federal agencies. FDA anticipates that most of the 2002 CFP recommendations with which the Federal agencies agree will be addressed in the 2005 Food Code.

The Supplement has been organized to facilitate the adoption of its provisions by Federal, state, local, and tribal authorities. The Supplement is divided into 3 Parts:

Part 1 - Summary of Changes - a "quick view" of the modifications
Part 2 - Amendments, Additions, Deletions to Chapters 1-8 and the Annexes - actual language modifications
Part 3 - New Terms for the Index to the Food Code

For consistency, drafting conventions used in the Federal Register for proposed rules are used in the Supplement to the 2001 Food Code. The standard terms to be used to describe a change are:

Amend. "Amend" means that an existing Food Code provision has changed. Because it is an introductory term, it is always used with one of the following specific amendatory terms to precisely describe the change to the Food Code provision.

Amendatory Terms

Add - means a new provision has been inserted in the Food Code.
Redesignate - means to modify a Food Code provision by reformatting the text of the provision into a new structural nomenclature designation.
Remove - means an existing provision is being taken out of the Food Code.
Revise - means an existing Food Code provision is replaced in part, or in its entirety.

For example:

Amend § 4-204.110 to revise subparagraph (B)(1) and to add subparagraph (B)(3) to read as follows: [text of changed subparagraph and newly added subparagraph]

Modifications are organized by Food Code chapter and are identified by Section number and title, and the paragraph, (e.g., 9-101.11(A)) or subparagraph (e.g., 9-101.00(A)(1)) to which the change is made. The full text of a Section is provided only if necessary to provide the proper context. Using Chapter 3 as an example, a change is introduced as follows:

Chapter 3     Food

Amend § 3-202.11 to revise paragraph (D) to read as follows:

Specifications for Receiving

   3-202.11 Temperature.*

[text of changed paragraph]

Using Chapter 4 as an example, a change to the Annexes is introduced as follows:

Annex 3      Public Health Reasons/Administrative Guidelines

   4-501.112 Mechanical Warewashing Equipment, Hot Water Sanitization Temperatures.

Amend Public Health Reason for § 4-501.112 to revise to read as follows:

[text of changed paragraph]

We encourage all jurisdictions to examine the level of food safety protection their current rules and implementation strategies provide and take the steps necessary to increase that level in light of the 2001 Food Code and its Supplement. Food Code adoption and implementation in all jurisdictions is an important strategy for achieving uniform national food safety standards and for enhancing the efficiency and effectiveness of our nation's food safety system.

The Department of Health and Human Services (DHHS) and USDA, along with state and local, and other federal and tribalgovernment agencies and the food industry, share responsibility for ensuring that our food supply is safe. DHHS and USDA, in partnership with numerous others, will continue to take progressive steps to strengthen our nation's food safety system. We look forward to achieving uniform and effective standards of food safety for food service, retail stores, and other retail-level establishments nationwide.

IMPORTANT. This entire Supplement to the 2001 Food Code is intended to keep the 2001 Food Code up-to-date. Changes, additions, deletions, and format modifications listed herein constitute revisions to the 2001 Food Code effective upon issuance.

Part 1     Summary of Changes

The amendments to the 2001 Food Code and its Annexes contained in the Supplement are summarized below. If an amendment relates directly to a recommendation of the Conference for Food Protection (CFP), the CFP issue number is provided in parenthesis immediately after the summary entry.

Preface

Item 9(A)
Revised the Food Code revision cycle from 2 years to 4 years (CFP Issue 2002-II-22)

Item 10
Revised the Acknowledgements paragraph to update the text

Chapter 1 Definitions
Added definitions for the terms "disclosure" and "reminder" (CFP Issue 2002-II-20)

Chapter 2

2-102.11(A)
Added language to define what is meant by "complying with this Code" with respect to demonstration of knowledge by the person in charge (CFP Issue 2002-I-28)

2-301.16(A)(2)
Revised the criteria for hand sanitizers to more accurately and concisely identify current federal food additive regulations that relate to hand sanitizer formulations and redesignated (A)(2) as (A)(2)(a)-(d)

Chapter 3

3-202.11(D)
Revised hot holding temperature requirement for receiving potentially hazardous foods from 60°C (140°F) to 57°C (135°F). (CFP Issue 2002-III-14)

3-301.11(B) and (C)
Revised language of paragraph (B), redesignated paragraph (C) as paragraph (D) and added new paragraph (C) prohibiting bare hand contact with ready-to-eat food by food employees in food establishments serving highly susceptible populations (CFP Issue 2002-III-24)

3-304.12(F)
Revised hot holding temperature requirement for storing in-use utensils from 60°C (140°F) to 57°C (135°F). (CFP Issue 2002-III-14)

3-304.14
Added new paragraph (E) to address storage of wiping cloth containers (CFP Issue 2002-I-31)

3-306.13(A)
Revised and redesignated paragraph (A) as subparagraphs (A)(1) and (A)(2) regarding consumer self-service operations (CFP Issue 2002-I-04)

3-401.11(D)
Added language regarding a consumer's selection of raw or under cooked animal foods (CFP Issue 2002-II-21) and a reference to 3-801.11 (C) (1)-(2)

3-401.13
Revised hot holding temperature requirement for plant food cooking and hot holding, from 60°C (140°F) to 57°C (135°F) (CFP Issue 2002-III-14)

3-403.11(C)
Revised hot holding temperature requirement involving reheating for hot holding from 60°C (140°F) to 57°C (135°F) (CFP Issue 2002-III-14)

3-501.14(A)
Revised the initial timed cooling temperature from 60°C (140°F) to 57°C (135°F) and clarified the intent of the cooling parameters (CFP Issue 2002-III-40)

3-501.16 (A)(1)
Revised hot holding temperature requirement for potentially hazardous foods from 60°C (140°F) to 57°C (135°F) (CFP Issue 2002-III-14)

3-502.12(B)(5)
Revised to include "except the time the product is maintained frozen" (CFP Issue 2002-III-38)

3-603.11
Revised to require a disclosure and reminder for satisfactory compliance with the consumer advisory provision (CFP Issue 2002-II-20)

3-801.11
Revised the section title by removing the words, "Prohibited Reservice"

Removed prohibition of the re-service of food in an unopened, original package to highly susceptible populations (CFP Issue 2002-I-01)

Added prohibition of bare hand contact with ready-to-eat food for food employees in food establishments serving highly susceptible populations (CFP Issue 2002-III-24)

Chapter 4

4-204.111(B)(2)
Revised vending machine automatic shutoff requirement for potentially hazardous foods that are held hot from 60°C (140°F) to 57°C (135°F) (CFP Issue 2002-III-14)

4-204.117
Removed the words, "designed and" from the introductory phrase to clarify that the warewashing machine's features prescribed in this section are not necessarily integrated into the machine design by the manufacturer and instead may be added at the time of installation

4-602.11(D)(7)
Revised hot holding requirement for in-use utensils stored in water from 60°C (140°F) to 57°C (135°F) (CFP Issue 2002-III-14)

Chapter 8

8-402
Revised Subpart title to include "competency" (CFP Issue 2002-II-14)

8-402.10
Added new paragraph to address competency of inspectors (CFP Issue 2002-II-14)

Annex 2

3-501.16
2. BIBLIOGRAPHY
Added new references for the hot holding of potentially hazardous food

Annex 3

2-301.16
Expanded the explanation of the applicable federal regulations pertaining to substances that are "generally recognized as safe (GRAS)" and substances that are the subject of a Food Contact Substance Notification in relation to their use in hand sanitizers

3-301.11
Added explanation for prohibiting bare hand contact in establishments serving highly susceptible populations

3-401.11
Added new paragraph to the introductory text regarding a consumer's right to select raw or undercooked animal foods

3-501.14
Revised to include additional information on cooling

3-501.16
Amended the temperature "Danger Zone," by replacing 60°C (140°F) with 57°C (135°F) and added discussion of the temperature criteria for hot holding of potentially hazardous foods

3-502.12
Added new paragraph discussing the use of proper cooling and freezing in reduced oxygen packaged products

3-603.11
Added new paragraphs under, "Satisfactory Compliance" that provides additional information on how to achieve compliance with the disclosure and reminder requirements for consumer advisories

4-501.112
Revised the section to specify the temperature parameters of a warewasher using hot water for sanitizing

4-703.11
Revised the section to discuss the utensil surface temperature that must be reached to ensure sanitization

8-402.10
Added new section to address the competency of inspectors

Annex 4

3. STAFF TRAINING
Revised the introductory text

Part 2     Amendments, Additions, Deletions to Chapters 1-8 and the Annexes

Preface

9. THE CODE REVISION PROCESS

Amend § 9 to revise paragraph (A) to read as follows:

FDA is issuing a new edition of the Food Code every 4 years. During the 4-year span of time between editions, FDA may issue supplements to an existing edition. Each new edition will incorporate the changes made in the supplement as well as any new revisions.

10. ACKNOWLEDGMENTS

Amend § 10 to revise the paragraph to read as follows:

Many individuals devoted considerable time and effort in addressing concerns and developing recommendations that are now reflected in the Food Code. These individuals represent a wide diversity of regulators, educators, industry leaders, and consumer representatives acting through their agencies, companies, professional groups, or trade organizations. It is only through the dedicated efforts and contributions of experienced professionals that a scientifically sound, well focused, and up-to-date model code is possible. FDA acknowledges with gratitude the substantial assistance of those who contributed to public health and food safety in the development of the Food Code.

Chapter 1     Purpose and Definitions
Ammendments, Additions, and Deletions

Amend § 1-201.10 to add to paragraph (B) the following defined terms:

Applicability and Terms Defined

   1-201.10 Statement of Application and Listing of Terms.

Applicability and Terms Defined 1-201.10 Statement of Application and Listing of Terms.

(B) Terms Defined.

Disclosure.

"Disclosure" means a written statement that clearly identifies the animal-derived foods which are, or can be ordered, raw, undercooked, or without otherwise being processed to eliminate pathogens in their entirety, or items that contain an ingredient that is raw, undercooked, or without otherwise being processed to eliminate pathogens.

Reminder.

"Reminder" means a written statement concerning the health risk of consuming animal foods raw, undercooked, or without otherwise being processed to eliminate pathogens.

(Return to Food Code 2001)

Chapter 2     Management and Personnel
Ammendments, Additions, and Deletions

Amend § 2-102.11 to revise paragraph (A) to read as follows::

   2-102.11 Demonstration.*

Based on the risks of foodborne illness inherent to the food operation, during inspections and upon request the person in charge shall demonstrate to the regulatory authority knowledge of foodborne disease prevention, application of the Hazard Analysis Critical Control Point principles, and the requirements of this Code. The person in charge shall demonstrate this knowledge by:

(Return to Food Code 2001)

Amend § 2-301.16 to revise subparagraph (A)(2) and redesignate as (A)(2)(a)-(d) to read as follows:

   2-301.16 Hand Sanitizers.

(Return to Food Code 2001)

Chapter 3     Food
Ammendments, Additions, and Deletions

Amend § 3-202.11 to revise paragraph (D) to read as follows:

Specifications for Receiving

   3-202.11 Temperature.*

(Return to Food Code 2001)

Amend § 3-301.11 to revise paragraph (B), redesignate paragraph (C) as paragraph (D), and add a new paragraph (C) to read as follows:

Preventing Contamination by Employees

   3-301.11 Preventing Contamination from Hands*

(Return to Food Code 2001)

Amend § 3-304.12 to revise paragraph (F) to read as follows:

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

During pauses in food preparation or dispensing, food preparation and dispensing utensils shall be stored:

(Return to Food Code 2001)

Amend § 3-304.14 to add new paragraph (E) to read as follows:

   3-304.14 Wiping Cloths, Use Limitation.

(Return to Food Code 2001)

Amend § 3-306.13 to revise and redesignate paragraph (A) as paragraph (A) and subparagraphs (A)(1) and (A)(2) to read as follows:

   3-306.13 Consumer Self-Service Operations.*

(Return to Food Code 2001)

Amend § 3-401.11 to revise paragraph (D) to read as follows:

Cooking

   3-401.11 Raw Animal Foods.*

(Return to Food Code 2001)

Amend § 3-401.13 to revise to read as follows:

   3-401.13 Plant Food Cooking for Hot Holding.

Fruits and vegetables that are cooked for hot holding shall be cooked to a temperature of 57°C (135°F).

(Return to Food Code 2001)

Amend § 3-403.11 to revise paragraph (C) to read as follows:

   3-403.11 Reheating for Hold Holding.*

(Return to Food Code 2001)

Amend § 3-501.14 to revise paragraph (A) to read as follows:

   3-501.14 Cooling.*

(Return to Food Code 2001)

Amend § 3-501.16 to revise subparagraph (A)(1) to read as follows:

   3-501.16 Potentially Hazardous Food, Hot and Cold Holding.*

(Return to Food Code 2001)

Amend § 3-502.12(B) to revise subparagraph (B)(5) to read as follows:

Clostridium botulinum Controls

   3-502.12 Reduced Oxygen Packaging, Criteria.*

(Return to Food Code 2001)

Amend § 3-603.11 to revise to read as follows:

Consumer Advisory

   3-603.11 Consumption of Animal Foods that are Raw, Undercooked, or Not Otherwise Processed to Eliminate Pathogens.*

(Return to Food Code 2001)

Amend § 3-801.11 to remove the words, "Prohibited Reservice" from the tag line to revise the title to read as follows:

Additional Safeguards

   3-801.11 Pasteurized Foods and Prohibited Food.*

(Return to Food Code 2001)

Amend § 3-801.11 to remove paragraph (C), redesignate paragraph (D) as paragraph (C), and add new paragraph (D) to read as follows:

Additional Safeguards

   3-801.11 Pasteurized Foods and Prohibited Food.*

In a food establishment that serves a highly susceptible population:

(Return to Food Code 2001)

Chapter 4     Equipment, Utensils and Linens
Ammendments, Additions, and Deletions

Amend § 4-204.111 to revise subparagraph (B)(2) to read as follows:

   4-204.111 Vending Machines, Automated Shutoff.*

(Return to Food Code 2001)

Amend § 4-204.117 to revise the introductory text to read as follows:

   4-204.117 Warewashing Machines, Automatic Dispensing of Detergents and Sanitizers.

A warewashing machine that is installed after adoption of this Code by the regulatory authority, shall be equipped to:

(Return to Food Code 2001)

Amend § 4-602.11(D) to revise subparagraph (D)(7) to read as follows:

   4-602.11 Equipment Food-Contact Surfaces and Utensils.*

(Return to Food Code 2001)

Chapter 8     Compliance and Enforcement
Ammendments, Additions, and Deletions

Amend to revise Subpart title for 8-4 to read as follows:

Applicability and Terms Defined

   8-402 Competency and Access

(Return to Food Code 2001)

Amend to add § 8-402.10 to read as follows:

Applicability and Terms Defined

   8-402.10 Competency of Inspectors.

An authorized representative of the regulatory authority who inspects a food establishment or conducts plan review for compliance with this Code shall have the knowledge, skills, and ability to adequately perform the required duties.

(Return to Food Code 2001)

Annex 2     References, 2. BIBLIOGRAPHY, Chapter 3
Ammendments, Additions, and Deletions

   3-501.16 Potentially Hazardous Food, Hot and Cold Holding.*

Amend References for § 3-501.16 to add new references and redesignate numbering to read as follows:

  1. Abdul-Raouf, U.M., L.R. Beauchat and M.S. Ammar, 1993. Survival and growth of Escherichia coli:O157:H7 in ground roasted beef as affected by pH, acidulants, and temperature. Appl. Environ. Microbiol. 59(8):2364-2368.
  2. Ahmed, A. A., M.K. Moustafa and E.H. Marth. 1983. Incidence of Bacillus cereus in milk and some milk products. J. Food Prot. 46:126-128.
  3. Angelotti, R., M.J. Foter and K.L. Lewis, 1961. Time-temperature effects on Salmonellae and Staphylococci in foods. II. Behavior in warm holding temperatures. Am. J. Public Health 51:76-88.
  4. Baxter R. and W.H. Holzapfel. 1982. A microbial investigation of selected spices, herbs, and additives in South Africa. J. Food Sci. 47: 570-578.
  5. Blankenship, L.C. Craven, S.C., Leffler, R. G. and C. Custer. 1988. Growth of Clostridium perfringensin cooked chilli during cooling. Appl. Environ. Microbiol. 54: 1104-1108.
  6. Brown, D.F. and R.M. Twedt, 1972. Assessment of the sanitary effectiveness of holding temperatures on beef cooked at low temperature.Appl. Microbiol. 24: 599-603.
  7. Bryan, F.L., C.A. Bartleson, and N. Christopherson. 1981. Hazard analyses, in reference to Bacillus cereus, of boiled and fried rice in Cantonese-style restaurants. J. Food Prot. 44:500-512.
  8. Collee, J.G., Knolden, J.A. and B.C. Hobbs. 1961. Studies on the growth, sporulation and carriage of Clostridium welchii with special reference to food poisoning strains. J. Appl. Bacteriol. 24:326-329.
  9. Craven, S.E. Blankenship, L.C. and J.L. McDonel. 1981. Relationship of sporulation, enterotoxin formation and spoilage during growth of Clostridium perfringens type A in cooked chicken. Appl. Environ. Microbiol. 41: 1184-1191.
  10. Doyle, M.P., N.J. Bains, J.L. Schoeni and E.M. Foster, 1982. Fate of Salmonella typhimurium and Staphylococcus aureus in meat salads prepared with mayonnaise. J. Food Prot. 45:152-156.
  11. El-Sherbeeny, M.R., M.F. Saddik, H.E-L. Aly, and F.L. Bryan. 1985. Microbiological profile and storage temperatures of Egyptian rice dishes. J. Food Prot. 48: 39-43.
  12. Fermanian, C., Fremy, M. and M. Claisse. 1994. Effect of temperature on the vegetative growth of type and field strains of Bacillus cereus. Let. Appl. Microbiol. 19: 414-418
  13. Hall, H.E. and R. Angelotti. 1965. Clostridium perfringens in meat and meat product. Applied Microbiology. 13: 352-354
  14. Johnson, K. M., Nelson, C. L. and F. F. Busta. 1983. Influence of temperature on germination and growth of spores of emetic and diarrheal strains of Bacillus cereus in a broth model and in rice. J. Food Sci. 48: 286-287.
  15. Kim, H.U. and J.M. Goepfert. 1971. Occurrence of Bacillus cereus in selected dry food products. J. Milk Food Technol. 34:12-15.
  16. Ladiges, W.C., J.F. Foster and W.M. Ganz. 1974. Incidence and viability of Clostridium perfringens in ground beef. J.Milk Food Technol. 37(12) 622-623.
  17. Lillard, H.S. 1971. Occurance of Clostridium perfringens in boiler processing and further processing operations. J. Food Science. 36: 1008-1010.
  18. Makukutu, C.A. and R.K. Guthrie, 1986. Survival of Escherichia coli in food at hot-holding temperatures. J. Food Prot. 49(7):496-499.
  19. Mead, G.C. 1969. Growth and sporulation of Clostridium welchii in breast and leg muscle of poultry. J. Appl Bacteriol. 32:86-95.
  20. Mead, P., L. Slutsker, V. Dietz, L. F. McCaig, J. S. Bresee, C. Shapiro, P. M. Griffin, and R. V. Tauxe. 1999. Food related illness and death in the United States. Emerging Infect Dis 5:607-625.
  21. Mikolajcik, E. M., Kearney, J.W. and T. Kristofferson. 1973. Fate of Bacillus cereus in cultured and direct acidified skim milk and cheddar cheese. J Milk Food Technol. 36: 317-320.
  22. Morita, T.N. and M.J. Woodburn. 1977. Stimulation of Bacillus cereus growth by protein in cooked rice combinations. J. Food Sci. 42 (5) 1232-1235.
  23. Nakamura, M. and K.D. Kelly. 1968. Clostridium perfringens in dehydrated soups and sauces. J. Food Science 33:424-426.
  24. Park, Y. and E.M. Mikolaicik. 1979. Effect of temperature on growth and alpha toxin production by Clostridium perfringens. J Food Protect. 42:848-851.
  25. Rusul, G. and N. H. Yaacob. 1995. Prevalence of Bacillus cereus in selected foods and detection of enterotoxin using TECRA-VIA and BCET-RPLA. Int. J. Food Microbiol. 25: 131-139.
  26. Seals, J.E., J.D. Snyder, T.A. Edell et al., 1981. Restaurant associated botulism: transmission by potato salad. Am. J. Epidemiol. 113:436-444.
  27. Shoemaker, S. P., and M. D. Pierson. 1976. "Phoenix phenomenon" in the growth of Clostridium perfringens. Appl. Environ. Micro. 32(6): 803-807.
  28. Smart, J.L., T.A. Roberts, M.F. Stringer, and N. Shah. 1979. The incidence and serotypres of Clostridium perfringens on beef, pork and lamb carcasses. J. Applied Bacteriology. 46:377-383.
  29. Solomon, H.M. and D.A. Kautter, 1988. Outgrowth and toxin production by Clostridium botulinum in bottles of chopped garlic. J. Food Prot. 51(11):862-865.
  30. Strong, D., J.C. Canada and B. Griffiths. 1962. Incidence of Clostridium perfringens in American foods. Appl. Microbiol. 11:42-44.
  31. Strong, D.H. and N.M. Ripp, 1967. Effect of cooking and holding on hams and turkey rolls contaminated with Clostridium perfringens. Appl. Microbiol. 15:1172-1177.
  32. Willardsen, R.R., F.F. Busta, C.E. Allen and L.B. Smith, 1978. Growth and survival of Clostridium perfringens during constantly rising temperatures. J. Food Sci. 43:470-475.
  33. Willardsen, R.R., Busta, F.F., Allen, C.E. 1979. Growth of Clostridium perfringens in three different beef media and fluid thioglycollate medium at static and constantly rising temperatures. J. Food Protect. 42: 144-148.

(Return to Food Code 2001)

Annex 3     Public Health Reasons/Administrative Guidelines, Chapter 2 Management and Personnel
Ammendments, Additions, and Deletions

   2-301.16 Hand Sanitizers.

Amend Public Health Reasons for § 2-301.16 to revise to read as follows:

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. Because of the need both to protect workers and to ensure safe food, hand sanitizers must comply with both the human drug and the food safety provisions of the law. -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 two means by which a hand sanitizer is considered to be safe and effective when applied to human skin:

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-specific" 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.

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. However, as of May 2003, no hand sanitizers have been shown to be acceptable through this process since the monograph has not been finalized.

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 subject to regulation under the food additive provisions of the Federal Food, Drug, and Cosmetic Act, the substances in a hand sanitizer must reasonably be expected to become a component of food based upon the product's intended use.

Where the substances in a hand sanitizer are reasonably expected to become a component of food based upon the product's intended use, circumstances under which those substances may be legally used include the following:

  1. The intended use of a substance may be exempted from regulation as a food additive under 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 in order to determine whether such an exemption can be granted.

  2. A substance may be regulated for the intended use as a food additive under 21 CFR 174 - Indirect Food Additives - General, and be listed along with conditions of safe use in 21 CFR 178 - Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers. 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. The intended use of a substance, including substances that contact food such as those in hand sanitizers, may be "generally recognized as safe (GRAS)" within the meaning of the FFDCA. A partial listing of substances with food uses that are generally recognized as safe may be found in CFR Parts 182, 184, and 186. These lists are not exhaustive because the FFDCA allows for independent GRAS determinations.

    For the use of a substance to be GRAS within the meaning of the FFDCA, there must be publicly available data that demonstrates that the substance is safe for its intended use. There also must be a basis to conclude that there is a consensus among qualified experts that these publicly available data establish safety. If the use of a substance in food is GRAS, it is not subject to premarket review by FDA. While there is no legal requirement to notify FDA of an independent GRAS determination, a number of firms have chosen to do so with the expectation of receiving a response letter from FDA (see FDA's Inventory of GRAS Notices at http://www.cfsan.fda.gov/~rdb/opa-gras.html). Although such a letter does not affirm the independent GRAS determination, it is an opportunity for the firm to receive comment from FDA regarding the materials supporting its determination.

  4. A substance may be the subject of a Food Contact Substance Notification that became effective in accordance with the FFDCA section 409 (h). Substances that are the subject of an effective food contact substance notification are listed, along with conditions of safe use, in the FDA Inventory of Effective Premarket Notifications for Food Contact Substances. This list is available on-line at http://www.cfsan.fda.gov/~dms/opa-fcn.html. A food-contact substance that is the subject of an effective notification submitted under FFDCA 409(h) does not include similar or identical substances manufactured or prepared by any person other than the manufacturer identified in that notification.

The Division of Food Contact Substance Notifications does not certify or provide approvals for specific products. However, if the intended use of a substance in contact with food meets the requirements 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 intended use of this product is exempt from regulation as a food additive. 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 substances in hand sanitizers as food additives may be directed to the Division of Food Contact Substance Notifications, HFS-275, 5100 Paint Branch Parkway, College Park, MD 20740. It may be helpful or necessary to provide label/promotional information when inquiring about a specific substance.

(Return to Food Code 2001)

Annex 3     Public Health Reasons/Administrative Guidelines, Chapter 3:  Food
Ammendments, Additions, and Deletions

   3-301.11 Preventing Contamination from Hands.*

Amend Public Health Reasons for § 3-301.11 to add the following sentence to the end of the second paragraph under," Clarification of ¶ 3-301.11(B) of the FDA Food Code with Respect to the Phrase "Except... when otherwise approved" :

Due to the immunocompromised condition of highly susceptible populations, alternatives to the no bare hand contact with ready-to-eat food requirement are prohibited in establishments serving these populations.

(Return to Food Code 2001)

   3-401.11 Raw Animal Foods.*

Amend Public Health Reasons for § 3-401.11 to add the following two paragraphs to the end of the introductory text:

The requirements specified under 3-401.11(D) acknowledge the rights of an informed consumer to order and consume foods as preferred by that consumer based on the consumer's health status and understanding of the risks associated with eating raw or partially-cooked animal foods.

In consumer self-service operations, such as buffets, salad bars, sushi bars, or display cases, the consumer advisory as specified under 3-603.11 must be posted or available at the self-service unit where the raw or partially cooked food is held for service and readily accessible to the consumer prior to making their food selections. In a catered situation, such as a wedding reception, each guest is responsible for making his or her own requests or selections.

(Return to Food Code 2001)

   3-501.14 Cooling.*

Amend Public Health Reasons for § 3-501.14 to add the following paragraph after the first paragraph of the introductory text:

The Food Code provision for cooling provides for cooling from 135°F to 41°F or 45°F in 6 hours, with cooling from 135°F to 70°F in 2 hours. The 6-hour cooling parameter, with an initial 2-hour rapid cool, allows for greater flexibility in meeting the Code. The initial 2-hour cool is a critical element of this cooling process. An example of proper cooling might involve cooling from 135°F to 70°F in 1 hour, in which case 5 hours remain for cooling from 70°F to 41°F or 45°F. Conversely, if cooling from 135°F to 41°F or 45°F is achieved in 6 hours, but the initial cooling to 70°F took 3 hours, the food safety hazards may not be adequately controlled.

(Return to Food Code 2001)

   3-501.16 Potentially Hazardous Food, Hot and Cold Holding.*

Amend Public Health Reasons for § 3-501.16 to add the following four paragraphs to the end of the section:

Hot Holding

In a January 2001 report, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) recommended that the minimum hot holding temperature specified in the Food Code:

C. perfringens has been reported to grow at temperatures up to 52°C (126°F). Growth at this upper limit requires anaerobic conditions and follows a lag phase of at least several hours. The literature shows that lag phase duration and generation times are shorter at incubation temperatures below 49°C (120°F) than at 52°C (125°F). Studies also suggest that temperatures that preclude the growth of C. perfringens also preclude the growth of B. cereus.

CDC estimates that approximately 250,000 foodborne illness cases can be attributed to C. perfringens and B. cereus each year in the United States. These spore-forming pathogens have been implicated in foodborne illness outbreaks associated with foods held at improper temperatures. This suggests that preventing the growth of these organisms in food by maintaining adequate hot holding temperatures is an important public health intervention.

Taking into consideration the recommendations of NACMCF and the 2002 Conference for Food Protection, FDA believes that maintaining food at a temperature of 57°C (135°F) or greater during hot holding is sufficient to prevent the growth of pathogens and is therefore an effective measure in the prevention of foodborne illness.

(Return to Food Code 2001)

   3-502.12 Reduced Oxygen Packaging, Criteria.*

Amend Public Health Reasons for § 3-502.12 to add the following paragraph to the end of the section:

Formation of Clostridium botulinum toxin may not be a significant hazard in reduced oxygen packaged products which are properly cooled and frozen immediately after processing, maintained frozen, and labeled to be held frozen and to be thawed under refrigeration immediately before use (e.g. "Important: Keep frozen until used. Thaw under refrigeration immediately before use.")

(Return to Food Code 2001)

   3-603.11 Consumption of Raw or Undercooked Animal Foods.*

Amend Public Health Reasons for § 3-603.11 to add the following three paragraphs to the end of the existing text under, "Satisfactory Compliance":

The information contained in both the disclosure and reminder should be publicly available and readable so that consumers have benefit of the total message (disclosure and reminder) before making their order selections.

It is not possible to anticipate all conceivable situations. Therefore, there will always be need for discussion between the food establishment and the Regulatory Authority as to the most effective way to meet the objectives of satisfactory compliance.

The Implementation Guidance for the Consumer Advisory Provision of the FDA Food Code (Section 3-603.11 in the 1999 FDA Model Food Code), March 22, 2000 is a resource intended to assist regulators and industry in the implementation of the Consumer Advisory provision. It is recommended that it be used in conjunction with the FDA Food Code. It is available on the FDA/CFSAN web page at http://www.cfsan.fda.gov/~dms/fc99guid.html

(Return to Food Code 2001)

Annex 3     Public Health Reasons/Administrative Guidelines, Chapter 4:  Equipment, Utensils, and Linens
Ammendments, Additions, and Deletions

   4-501.112 Mechanical Warewashing Equipment, Hot Water Sanitization Temperatures.

Amend Public Health Reasons for § 4-501.112 to revise to read as follows:

The temperature of hot water delivered from a warewasher sanitizing rinse manifold must be maintained according to the equipment manufacturer's specifications and temperature limits specified in this section to ensure surfaces of multiuse utensils such as kitchenware and tableware accumulate enough heat to destroy pathogens that may remain on such surfaces after cleaning.

The surface temperature must reach at least 71°C (160°F) as measured by an irreversible registering temperature measuring device to affect sanitization. When the sanitizing rinse temperature exceeds 90°C (194°F) at the manifold, the water becomes volatile and begins to vaporize reducing its ability to convey sufficient heat to utensil surfaces. The lower temperature limits of 74°C (165°F) for a stationary rack, single temperature machine, and 82°C (180°F) for other machines are based on the sanitizing rinse contact time required to achieve the 71°C (160°F) utensil surface temperature.

(Return to Food Code 2001)

   4-703.11 Hot Water and Chemical.*

Amend Public Health Reasons for § 4-703.11 to revise to read as follows:

Efficacious sanitization depends on warewashing being conducted within certain parameters. Time is a parameter applicable to both chemical and hot water sanitization. The time hot water or chemicals contact utensils or food-contact surfaces must be sufficient to destroy pathogens that may remain on surfaces after cleaning. Other parameters, such as rinse pressure, temperature, and chemical concentration are used in combination with time to achieve sanitization.

When surface temperatures of utensils passing through warewashing machines using hot water for sanitizing do not reach the required 71°C (160°F), it is important to understand the factors affecting the decreased surface temperature. A comparison should be made between the machine manufacturer's operating instructions and the machine's actual wash and rinse temperatures and final rinse pressure. The actual temperatures and rinse pressure should be consistent with the machine manufacturer's operating instructions and within limits specified in §§ 4-501.112 and 4-501.113.

If either the temperature or pressure of the final rinse spray is higher than the specified upper limit, spray droplets may disperse and begin to vaporize resulting in less heat delivery to utensil surfaces. Temperatures below the specified limit will not convey the needed heat to surfaces. Pressures below the specified limit will result in incomplete coverage of the heat-conveying sanitizing rinse across utensil surfaces.

(Return to Food Code 2001)

Annex 3     Public Health Reasons/Administrative Guidelines, Chapter 8:  Poisonous or Toxic Materials
Ammendments, Additions, and Deletions

Amend Public Health Reasons to add new § 8-402.10 to read as follows:

   8-402.10 Competency of Inspectors.

Regulatory agencies are encouraged to use Standard #2 of the draft National Voluntary Retail Food Regulatory Program Standards to ensure employees who inspect food establishments are properly trained. Regulatory inspectors are also encouraged to seek food safety certification through a nationally recognized and accredited program.

(Return to Food Code 2001)

Annex 4     Food Establishment Inspection, 3. STAFF TRAINING
Ammendments, Additions, and Deletions

Amend Public Health Reasons to revise the introductory text to read as follows:

Basic staff training is very important to staff development and should be a well-defined process. Initial training is usually provided within the local regulatory agency and more advanced training is available through a state agency's program. National training is available from the FDA's Division of Human Resource Development (ORA-U) and the State Training Team, and from the Centers for Disease Control and Prevention's Distance Learning Program. These programs range from basic to advanced subject-specific seminars offered regionally, to home study courses including video, slide, or textbook-based programs, and finally to direct satellite broadcast seminars and courses as a part of the Public Health Training Network.

FDA supports the concept of a competency standard for regulatory professionals and encourages development of education, training and certification criteria consistent with Standard 2 - Trained Regulatory Staff in the draft National Voluntary Retail Food Regulatory Program Standards.

There are many components of a valid and credible certification process. Different pre-requisite training and/or testing processes exist for regulators who will be responsible for inspection of foodservice and other retail food establishments. This range of perspectives speaks to the need for criteria that includes consensus support. FDA's draft National Voluntary Retail Food Program Standards were developed based on input from regulatory officials, industry professionals, and academia and consumer groups. Standard 2 - Trained Regulatory Staffincorporates an educational curriculum, field training, Food Code standardization, and continuing education as minimum criteria for assessing the competency of regulators.

(Return to Food Code 2001)

Part 3     New Terms for the Index to the Food Code
Ammendments, Additions, and Deletions

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