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FDA 2001 Food Code - Annex 2: References

U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
2001 Food Code (Updated April 2004*)
Supplement to the 2001 Food Code

 

Annex
2
 

    References

 

  1.   UNITED STATES CODE AND CODE OF FEDERAL REGULATIONS
  2.   BIBLIOGRAPHY
  3.   FDA SUPPORTING DOCUMENTS

1.     UNITED STATES CODE AND CODE OF FEDERAL REGULATIONS

The Food Code makes frequent reference to federal statutes contained in the United States Code (USC) and the Code of Federal Regulations (CFR). Copies of the USC and CFR can be viewed and copied at government depository libraries or may be purchased as follows.

  • (A) Viewing and Copying the USC or CFR

    • (1) Government Depository Library

      The USC and CFR are widely available for reference and viewing in some 1400 "depository libraries" located throughout the United States. A Directory of U.S. Government Depository Libraries is published by the Joint Committee on Printing of the United States Congress and is available through the Superintendent of Documents, U.S. Government Printing Office. This publication lists all depository libraries by state, city, and congressional district.

      Persons may also obtain information about the location of the depository library nearest to them by contacting:

      Library Programs Service, SL
      U.S. Government Printing Office
      North Capitol & H Streets, NW
      Washington, DC 20401
      (202) 512-1114, FAX (202) 512-1432

    • (2) Internet World Wide Web Information System

      The CFR are available on-line in downloadable form through the Internet World Wide Web information system. The source is:

      The National Archives and Records Administration
      Copies of Federal Regulations - Retrieve CFR by Citation
      Provided through the Government Printing Office Web Site - GPO Inet Services

      http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

  • (B) Purchasing Portions of the USC or CFR

    Persons wishing to purchase relevant portions of the USC or CFR may do so by writing:

    Superintendent of Documents (New Orders)
    U.S. Government Printing Office
    P.O. Box 371954
    Pittsburgh, PA 15250-7954

    or by calling:

    (202)512-1800 from 7:30 a.m. to 5:00 p.m. eastern time, Monday-Friday (except holidays). Orders may be charged to Discover/Novus, MasterCard or Visa.

  • (C) USC as it Relates to the Code Definition of "Adulterated"

    This language has been retyped as accurately as possible and inserted in the Food Code Annex for informational purposes. For legal purposes, use only language taken directly from the United States Code (USC).

    21 USC Sec.342 disclaimer icon
    Title 21 - Food and Drugs
    Chapter 9 - Federal Food, Drug and Cosmetic Act
    Subchapter IV - Food

ADULTERATED FOOD

Sec. 402 [342]

A food shall be deemed to be adulterated -

(a) Poisonous, insanitary, etc., ingredients

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; or

(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 406; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a); or ( C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 409; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512; or

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title.

(b) Absence, substitution, or addition of constituents

(1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

(c) Color additives

If it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e(a) of this title.

(d) Confectionery containing alcohol or nonnutritive substance

If it is confectionery, and -

(1) has partially or completely imbedded therein any nonnutritive object, except that this subparagraph shall not apply in the case of any nonnutritive object if, in the judgment of the Secretary as provided by regulations, such object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health;

(2) bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum by volume derived solely from the use of flavoring extracts, except that this clause shall not apply to confectionery which is introduced and delivered for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionery is permitted under the laws of the State in which such confectionery is intended to be offered for sale;

(3) bears or contains any nonnutritive substance, except that this subparagraph shall not apply to a safe nonnutritive substance which is in or on a confectionery by reason of its use for some practical functional purpose in the manufacture, packaging, or storage of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of any provision of this chapter, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph, issue regulations allowing or prohibiting the use of particular nonnutritive substances.

(e) Oleomargarine containing filthy, putrid, etc., matter

If it is oleomargarine or margarine or butter and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance, or such oleomargarine or margarine or butter is otherwise unfit for food.

(f) Dietary supplement or ingredient: safety

(1) If it is a dietary supplement or contains a dietary ingredient that -

(A) presents a significant or unreasonable risk of illness or injury under -

(i) conditions of use recommended or suggested in labeling,

or

(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;

(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;

( C) The Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5 to affirm or withdraw the declaration; or

(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a) (1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.

In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.

(2) Before the Secretary may report to a United States attorney a violation of paragraph

(1) (A) for a civil proceeding, the person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present views, orally and in writing, at least 10 days before such notice, with regard to such proceeding.

(g) Dietary supplement: manufacturing practices

(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2).

(2) the Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with chapter 5 of title 5, United States Code.

(As amended by 104th Congress, Fall, 1996.)

2. BIBLIOGRAPHY

The following bibliography is a compilation of documents that were taken into consideration in developing the Food Code.

 

     Preface

 

1. Archer, D.L. and J.E. Kvenberg, 1985. Incidence and cost of foodborne diarrheal disease in the United States. J. Food Prot. 48:887-894.

2. Committee on Salmonella, 1969. An Evaluation of the Salmonella Problem. NRC Pub. 1683, National Academy of Sciences, Washington, DC. 207 pp.

3. Council for Agricultural Science and Technology, 1994. Foodborne Pathogens: Risks and Consequences. Task Force Report No. 122, CAST, Ames, IA., 87 pp.

4. Federal Food, Drug and Cosmetic Act, . Factory Inspection.

5. Food and Drug Administration, January 24, 1994. Preliminary Regulatory Impact Analysis of the Proposed Regulations to Establish Procedures for the Safe Processing and Importing of Fish and Fishery Products.

6. Food and Drug Administration, 1996. Directory of State Officials, Transmittal 96-1, Division of Federal-State Relations, Rockville, MD.

7. Garthright, W.E., D.L. Archer and J.E. Kvenberg, 1988. Estimates of incidence and costs of intestinal infectious disease in the United States. Public Health Rep. 103:107-115.

8. Hirsch, D., 1989. Drafting Federal Law, 2nd Ed., Office of the Legislative Counsel, U. S. House of Representatives, Washington, DC. 122 pp.

9. Kvenberg, J.E. and D.L. Archer, 1987. Economic impact of colonization control on foodborne disease. Food Technol. 41:77-98.

10. Martineau, R.J., 1991. Drafting Legislation and Rules in Plain English, University of Cincinnati, Cincinnati, OH. 155 pp.

11. Maryland Office of the Secretary of State, 1991. Style Manual for Maryland Regulations, Div. of State Documents, Annapolis, MD. 58 pp.

12. McCracken, J.B. and G.P Carver, 1992. Recommended Agency Procedures for Implementing Federal Metric Policy. NISTIR 4855, U.S. Department of Commerce, National Institute of Standards and Technology, Technology Administration, Metric Program, Technology Services, Gaithersburg MD. 17 pp.

13. Mead, P.S., Slutsker, L., Dietz, V., McCraig, L.F., Bresee, J.S., Shapiro, C., Griffin, P.M., Tauxe, R.V., 1999. Food-related Illness and Death in the United States. Emerg. Infect. Dis. Vol. 5, No. 5, in: http://www.cdc.gov/ncidod/EID/vol5no5/mead.htm.

14. Metric Conversion Act of 1975, P.L. 94-168 Amended, 89 Stat. 1007; 15 U.S.C. §205a et seq.

15. Omnibus Trade and Competitiveness Act of 1988, P.L. 100-418.

16. Research Triangle Institute, 1988. Estimating the Value of Consumer's Loss from Foods Violating the FD&C Act, FDA Contract No. 233-86-2098.

17. The Public Health Service Act, 42 U.S.C. Section 243. General Grant of Authority for Cooperation.

18. Metric Systems of Measurement; Interpretation of the International System of Units for the United States. Notice published July 28, 1998, 63 FR 40334-40340. This Federal Register notice supercedes the previous interpretation published on December 20, 1990, 55 FR 52242-52245.

 

     Chapter 1 Purpose and Definitions

 

    1-201.10   Statement of Application and Listing of Terms

1. Code of Federal Regulations, Title 9, Section 362.1 Animals and Animal Products.

2. Code of Federal Regulations, Title 9, Section 354.1 Animal and Animal Products, Definitions.

3. Code of Federal Regulations, Title 50, Part 17 Endangered and Threatened Wildlife and Plants.

4. Code of Federal Regulations, Title 9, Subchapter A Part 301 Definitions.

5. Code of Federal Regulations, Title 9, Subchapter A Part 381 (932 KB) Poultry Products Inspection Regulations.

6. Code of Federal Regulations, Title 40, Part 141 (1,198 KB) National Primary Drinking Water Regulations.

7. Code of Federal Regulations, Title 40, Part 152.175 Pesticides classified for restricted use.

8. Doerry, W.T., 1996. Shelf-Stable Pumpkin Pies. A research report, American Institute of Baking, Manhattan, KS.

9. Federal Food, Drug and Cosmetic Act, and Code of Federal Regulations, and Title 21 Part 170 Food Additive.

10. Federal Food, Drug and Cosmetic Act, and Code of Federal Regulations, and Title 21 Part 70 Color Additive.

11. Federal Food, Drug and Cosmetic Act, Adulterated.

12. Federal Food, Drug and Cosmetic Act,  When Color Additives Deemed Unsafe.

13. Food and Drug Administration, 1997. Grade "A" Pasteurized Milk Ordinance. U.S. Department of Health and Human Services, Public Health Service. Washington, D.C., page 4.

14. Food and Drug Administration, 1997. National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, Public Health Service, Washington, D.C., page 7.

15. National Advisory Committee on Microbiological Criteria for Foods, 1992. Hazard Analysis and Critical Control Point System. Int. J. Food Microbiol. 16:1-23.

 

     Chapter 2 Management and Personnel

 

    2-102.11   Demonstration.*

1. Bean, N.H. and P.M. Griffin, 1990. Foodborne disease outbreaks in the United States, 1973-1987: pathogens, vehicles, and trends. J. Food Prot. 53:804-817.

2. Bryan, F.L., 1979. Prevention of foodborne diseases in food service establishments. J. Environ. Health 41:198-206.

3. Bryan, F.L., 1988a. Risks associated with vehicles of foodborne pathogens and toxins. J. Food Prot. 51(6):498-508.

4. Bryan, F.L., 1988b. Risks of practices, procedures and processes that lead to outbreaks of foodborne diseases. J. Food Prot. 51(8): 663-673.

5. Conference for Food Protection, 1992. National Standard for Unit Manager Food Safety Knowledge, Training, Testing and Certification Committee Report. 13 pp.

6. Doyle, M.P., 1991. Escherichia coli O157:H7 and its significance in foods. Int. J. Food Microbiol. 12:289-302.

7. Liston, J., 1990. Microbial hazards of seafood consumption. Food Technol. 44(12):56, 58-62.

8. World Health Organization, 1989. Health Surveillance and Management Procedures for Food-handling Personnel, Technical Report Series 785, WHO, Geneva, Switzerland. 50 pp.

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

    2-201.12   Exclusions and Restrictions.*

1. Americans with Disabilities Act of 1990, as Amended. 42 U.S.C. 12111 et seq.

2. Benenson, A.S. (Ed.), 1995. Control of Communicable Diseases Manual, 16th Ed., American Public Health Association, Washington, DC. 500 + pp.

3. Black, R.E., G.F. Graun and P.A. Blake, 1978. Epidemiology of common-source

outbreaks of shigellosis in the United States, 1961-1975. Am. J. Epidemiol. 108:47-52.

4. Centers for Disease Control and Prevention, Diseases Transmitted Through the Food Supply, 57(174) FR 40917 (August 15, 1996).

5. Centers for Disease Control Prevention, 1996-97. Health Information for International Travel, December, 1996. U.S. Department of Health and Human Services, National Center for Infectious Diseases, Division of Quarantine, Atlanta, Georgia. 165-176.

6. Code of Federal Regulations, Title 29, Part 1630 Regulations to Implement the Equal Employment Provisions of the Americans with Disabilities Act.

7. Doyle, M.P. (Ed.), 1989. Foodborne Bacterial Pathogens, Marcel Dekker, Inc., New York. 796 pp.

8. Doyle, M.P., T. Zhao, J. Meng, S. Zhao. 1997. Escherichia coli O157:H7. In Food Microbiology Fundamentals and Frontiers, M.P. Doyle, L.R. Beuchat, and T.J. Montville, eds. pp. 183-186. ASM Press, Wash., D.C.

9. Griffin, P.M. and R.V. Tauxe, 1991. The epidemiology of infections caused by Escherichia coli O157:H7, other enterohemorrhagic E. coli, and the associated hemolytic uremic syndrome. Epidemiol. Rev. 13:60-98.

10. Meade, P.S., Griffin, P.M., 1998. Escherichia coli O157:H7. Lancet 1998; 352: 1207-12.

11. Ryder, R.W. and P.A. Blake, 1979. Typhoid fever in the United States, 1975 and 1976. J. Infect. Dis. 139(1):124-126.

12. Shapiro, C.N., F.E. Shaw, E.J. Mandel, et al., 1991. Epidemiology of hepatitis A in the United States. In: Viral Hepatitis and Liver Disease, Hollinger, F.B., S.M. Lemon and H. Margolis (Eds.), Williams & Wilkins, Baltimore MD, pp. 71-76.

13. Soper, G.A., 1939. The curious career of Typhoid Mary. Bull. N.Y. Acad Med. 15:698-712.

14. Tauxe, R.V., K.E. Johnson, J.C. Boase, S.D. Helgerson and P.A. Blake, 1986. Control of day care shigellosis: A trial of convalescent day care in isolation. Am. J. Public Health 76(6):627-630.

15. Tauxe, R.V., N.D. Puhr, J.G. Wells, N. Hargrett-Bean and P.A. Blake, 1990. Antimicrobial resistance of Shigella isolates in the USA: The importance of international travelers. J. Infect. Dis. 162:1107-1111.

16. U.S. Department of Health and Human Services, Public Health Service, 1990. Healthy People 2000: National Health Promotion and Disease Prevention Objectives -

full report with commentary, DHHS Pub. No. (PHS) 91-50212, Washington DC. 143 pp.

17. Colorado Department of Health, 1993. Public Health Handbook For Management Of Acute Hepatitis A. Division of Disease Control and Environmental Epidemiology, 4300 Cherry Creek Drive South, Denver, CO 80222-1530, 27 pp.

18. Maryland Department of Health and Mental Hygiene, 1990. Guidelines for Investigation and Control of Hepatitis A. Epidemiology and Disease Control Program, 201 West Preston Street, Baltimore, MD 21201, 4 pp.

    2-201.13   Removal of Exclusions and Restrictions.

1. Benenson, A.S. (Ed.), 1995. Control of Communicable Diseases Manual, 16th Ed., American Public Health Association, Washington, DC. 500+ pp.

2. Code of Federal Regulations, Title 21, Part 110.10 Personnel. (a) Disease Control. " Any person who, by medical examination or supervisory observation is shown to have, or appears to have, an illness, ... shall be excluded from any operations which may be expected to result in contamination,... Personnel shall be instructed to report such health conditions to their supervisors."

3. Lee, L.A., C.N. Shapiro, N. Hargrett-Bean and R.V. Tauxe, 1991. Hyperendemic Shigellosis in the United States: A review of surveillance data for 1967-1988. J. Infect. Dis. 164:894-900.

4. Ryder, R.W. and P.A. Blake, 1979. Typhoid fever in the United States, 1975 and 1976. J. Infect. Dis. 139:124-126.

    2-301.12   Cleaning Procedure. (Handwashing)*

1. Ansari, S. A., Springthorpe, V. S., Sattar, S. A., Tostowaryk, W., and Wells, G. A.,1991. Comparison of cloth, paper, and warm air drying in eliminating viruses and bacteria from washed hands. Am. J. Infect. Cont., Vol.19. No. 5. pp. 243-249.

2. Ansari, S. A, Sattar, S. A., S., V. S., Wells, G. A. and Tostowaryk, W., 1989. In Vivo Protocol for Testing Efficacy of Hand-Washing Agents against Viruses and Bacteria: Experiments with Rotavirus and Escherichia coli. Appl. Environ. Microbiol., Vol. 55, No. 12. pp. 3113-3118.

3. Ansari, S. A., Sattar, S. A., Springthorpe, V. S., Wells, G. A., and Tostowaryk, W., 1988. Rotavirus Survival on Human Hands and Transfer of Infectious Virus to Animate and Nonpourous Inanimate Surfaces, J. Clin. Microbiol., Vol. 26, No. 8. pp.1513-1518.

4. Ayliffe, G.A.J., Babb, J.R., Davies, J.G., and Lilly, H.A., 1988. Hand disinfection: a comparison of various agents in laboratory and ward studies. J. Hosp. Infect., Vol. 11,

pp. 226-243.

5. Ayliffe, G.A.J., Babb, J.R., and Quoraishi, A.H., 1978. A test for 'hygienic' hand disinfection. J. Clin. Path., Vol. 31, pp. 923-928.

6. Bellamy, K., Alcock, R., Babb, J.R., Davies, J.G., and Ayliffe, G.A.J. 1993. A test for the assessment of 'hygienic' hand disinfection using rotavirus. J. Hosp. Infect., Vol. 24,

pp. 201-210.

7. Casewell, M., Phillips, I., 1977. Hands as route of transmission for Klebsiella species. Brit. Med. J. Vol. 2, No.19. pp.1315-1317.

8. Cliver, D. O., and Kostenbader, K. D., 1984. Disinfection of virus on hands for prevention of food-borne disease. Intern. J. Food Microbiol., Vol. 1, pp. 75-87.

9. De Witt, J.C. 1985. The importance of hand hygiene in contamination of foods. Netherlands Society for Microbiology, section for food microbiology meeting at Ede on 24 May, 1984. Antonie von Leeuwenhoek, Vol. 51, pp. 523-527.

10. Eckert, D.G., Ehrenkranz, N.J., Alfonso, B.C. 1989. Indications for alcohol or bland soap in removal of aerobic gram-negative skin bacteria: assessment by a novel method. Infect. Control Hosp. Epidemiol., Vol. 10, pp. 306-311.

11. Educational Foundation of the National Restaurant Association, 1992. The Safe Foodhandler, in Applied Foodservice Sanitation, 4th Ed. John Wiley & Sons, New York. pp 60-76.

12. Eggers, H. J. 1990. Experiments on Antiviral Activity of Hand Disinfectants. Some Theoretical and Practical Considerations. Zbl. Bakt. Vol.273, pp.36-51.

13. Ehrenkranz, N.J., 1992. Bland soap handwash or hand antisepsis? The pressing need for clarity. Infect. Control Hosp. Epidemiol., Vol. 13, No. 5, pp. 299-301.

14. Ehrenkranz, N.J., Alfonso, B., 1991. Failure of bland soap handwash to prevent hand transfer of patient bacteria to urethral catheters. Infect. Control Hosp. Epidemiol. Vol. 12, No. 11, pp. 654-662.

15. Garner, J.S. and M.S. Favero, 1985. Guidelines for Handwashing and Hospital Environmental Control. Hospital Infections Program, Center for Infectious Diseases, CDC, Atlanta, GA. pp. 7-9.

16. Kjolen H., and Andersen, B. M., 1992. Handwashing and disinfection of heavily contaminated hands -- effective or ineffective? J. Hosp. Infect., Vol. 21, pp. 61-71.

17. Lane, C.G., and Blank, I.H., 1942. Cutaneous Detergents. J.A.M.A. 118 (10): 804-816.

18. Larson, E.L., 1995. APIC Guideline for handwashing and hand antisepsis in health care settings, American J. Infect. Control, Vol. 23, No. 4, pp. 251-269.

19. Lilly, H.A, Lowbury, E.J.L. 1978. Transient skin flora. Their removal by cleansing or disinfection in relation to their mode of deposition. J. Clin. Path. Vol. 31, pp. 919-922.

20. Mbithi, J.N., Springthorpe, S., and Sattar, S., 1993. Comparative in vivo efficiencies of hand-washing agents against Hepatitis A virus (HM-175) and Poliovirus Type 1 (Sabin). Applied Environ Microbiol. Vol.59, No.10, pp. 3463-3469.

21. McGinley, K.J., Larson, E.L., and Leyden, J.J. 1988. Composition and Density of Microflora in the Subungual Space of the Hand. J. of Clin. Micro. 26(5): 950-953.

22. Minnesota Department of Health, 1990. Guidelines for the Prevention of the Transmission of Viral Hepatitis, Type A in the Food Service Area. Minnesota Department of Health, Div. Environ. Health, Minneapolis, MN. 2 pp.

23. Paulson, D.S., 1992. Evaluation of three handwashing modalities commonly

employed in the food processing industry. Dairy Food Environ. Sanit. 12(10):615-618.

24. Pether, J.V.S., and Gilbert, R.J., 1971. The survival of salmonellas on finger-tips and transfer of the organism to foods. J. Hyg. Vol. 69, pp. 673-681.

25. Price, P.B., 1938. The Bacteriology of Normal Skin; A New Quantitative Test Applied to a Study of the Bacterial Flora and the Disinfectant Action of Mechanical Cleansing, J. Infect. Dis. 63: 301-318.

26. Restaino, L. and Wind, C.E., 1990. Antimicrobial effectiveness of hand washing for food establishments. Dairy, Food and Environ. San. Vol.10, No. 3, pp.136-141.

27. Reybrouck, G., 1986. Handwashing and hand disinfection. J. Hosp. Infect. 8: 5-23.

28. Rotter, M.L., G.A.J. Ayliffe, 1991. Practical Guide on Rationale and Testing Procedures for Disinfection of Hands. World Health Organization. 57 pp.

29. Rotter, M.L., Koller, W., 1991. An European test for the evaluation of the efficacy of procedures for the antiseptic handwash? Hyg. Med., Vol. 16, pp.4-12.

 

30. Rose, J.B., and Slifko, T.R., 1999. Giardia, Cryptosporidium, and Cyclospora and their impact on foods: a review. J. Food Protect. Vol. 62., No. 9, pp. 1059-1070.

31. Sattar, S.A., and Springthorpe, V.S. 1996. Environmental spread and germicide control of viruses in hospitals. Infect Control & Steril.Tech, Vol. 2, no.7, pp. 30-36.

32. Schurmann, W., and Eggers, H.J. 1985. An experimental study on the epidemiology of enteroviruses: water and soap washing of poliovirus 1 -- contaminated hands, its effectiveness and kinetics. Med. Microbiol. Immunol. Vol. 174, pp. 221-236.

33. Smith, G.A., Jr, 1991. Handwashing et cetera, Lexington Board of Health, Personal Hygiene Sanitation Programs, Lexington, KY. 2 pp.

34. Stiles, M.E., and Sheena, A.Z. 1987. Efficacy of Germicidal Hand Wash Agents in Use in a Meat Processing Plant. J. Food Protect. 50 (4):289-295.

35. Sprunt, Katherine, Redman, Winifred, and Leidy, Grace, 1973. Antibacterial Effectiveness of Routine Hand Washing. Pediatrics, Vol. 52, No. 2, pp. 264-271.

36. Williams, R.E.O., 1963. Healthy carriage of Staphylococcus aureus: Its prevalence and importance. Bacteriol. Rev. 27:56-71.

    2-301.13   Special Handwashing Procedures.*

Reserved.

    2-301.14   When to Wash.*

1. Ojajarvi, J., 1980. Effectiveness of handwashing and disinfection methods in removing transient bacteria after patient nursing. J. Hyg. Camb. 85:193-203.

    2-301.16   Hand Sanitizers.

1. Code of Federal Regulations, Title 21, Part 178.1010 Sanitizing Solutions.

2. Food and Drug Administration, January, 1999. Investigations Operations Manual, Chapter 5, Establishment Inspection, Subchapter 530, Food Section 534, Equipment and Utensils.

3. Stiles, M.E. and A.Z. Sheena, 1987. Efficacy of germicidal hand wash agents in use in a meat processing plant. J. Food Prot. 50(4): 289-294.

    2-302.11   Maintenance. (Fingernails)

1. Pether, J.V.S. and R.J. Gilbert, 1971. The survival of salmonellas on finger-tips and transfer of the organisms to foods. J. Hyg. Camb. 69:673-681.

2. Pottinger, J., S. Burns, and C. Manake, 1989. Bacterial carriage by artificial versus natural nails. Am. J. Infect. Control, 17(6):340-344.

    2-303.11   Prohibition. (Jewelry)

    2-304.11   Clean Condition. (Outer Clothing)

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

    2-402.11   Effectiveness. (Hair Restraints)

1. Code of Federal Regulations, Title 21, Parts 110.10 Personnel. (b) (1) "Wearing outer garments suitable to the operation...." (4) "Removing all unsecured jewelry...." (6) "Wearing, where appropriate, in an effective manner, hair nets, head bands, caps, beard covers, or other effective hair restraints." (8) "Confining...eating food, chewing gum, drinking beverages or using tobbaco...." and (9) "Taking other necessary precautions...."

    2-403.11    Handling Prohibition. (Animals)*

1. Bond, R., L.E.M. Saijonmaa-Koulumies, and D.H. Lloyd, 1995. Population sizes and frequency of Malassezia pachydermatis at skin and mucosal sites on healthy dogs. J. Small Animal Pract. 36: 147-150.

2. Code of Federal Regulations,Title 21, Part 110.35(c).

3. Food and Drug Administration, 1985. Premises - Acceptability of pets in common dining areas of group residences (5/17/85). Retail Food Protection Program Information Manual.

4. Hirooka, Elisa Y., Ernest E. Muller, Julio C. Freitas, Eduardo Vicente, Yuko Yoshimoto, and Merlin S. Bergdoll. 1988. Enterotoxigenicity of Staphylococcus intermedius of canine origin. Int. J. Food Micro. 7: 185-191.

5. Khambaty, F.M., R.W. Bennett, and D.B. Shah. 1994. Application of pulsed-field gel electrophoresis to the epidemiological characterization of Staphylococcus intermedius implicated in a food-related outbreak. Epidemiol. Infect. 133: 75-81.

 

     Chapter 3 Food

 

    3-201.11   Compliance with Food Law.*

  1. Centers for Disease Control, 1987. International outbreak associated with ungutted, salted whitefish. Morb. Mortal. Wkly. Rep. 36:812-813.
  2. Code of Federal Regulations, Title 21, Part 16, Regulatory Hearing Before the Food and Drug Administration
  3. Code of Federal Regulations, Title 21, Part 101, Food Labeling
  4. Code of Federal Regulations, Title 21, Part 115, Shell Eggs
  5. Federal Register: (Volume 65, Number 234), Pages 76091-76114
  6. Goverd, K.A., F.W. Beech, R.P. Hobbs and R. Shannon, 1979. The occurrence and survival of coliforms and salmonellas in apple juice and cider. J. Appl. Bacteriol. 46:521-530.
  7. Zhao, T., M.P. Doyle and R.E. Besser, 1993. Fate of enterohemorrhagic Escherichia coli O157:H7 in apple cider with and without preservatives. Appl. Environ. Microbiol. 59(8): 2526-2530.

    3-201.12   Food in a Hermetically Sealed Container.*

1. Code of Federal Regulations, Title 21, Parts 108 - Emergency Permit Control, 113 - Thermally Processed Low-acid Foods Packaged in Hermetically Sealed Containers, and 114 - Acidified Foods.

    3-201.13   Fluid Milk and Milk Products.*

1. Black, R.E., R.J. Jackson, T. Tsai, M. Medvesky, M. Shaygani, J.C. Feely, K.I.E. MacLeod and A.M. Wakelee, 1978. Epidemic Yersinia enterocolitica infection due to contaminated chocolate milk. N. Engl. J. Med. 298:76-79.

2. Food and Drug Administration, 1997. Grade "A" Pasteurized Milk Ordinance. U.S. Department of Health and Human Services, Public Health Service, Washington, DC.

3. Potter, M.E., A.F. Kauffmann, P.A. Blake and R.A. Feldman, 1984. Unpasteurized milk: The hazards of a health fetish. J. Am. Med. Assoc. 252:2048-2052.

    3-201.14    Fish.*

1. Code of Federal Regulations, Title 21, Part 123 Fish and Fishery Products.

2. Engleberg, N.C., J.G. Morris, Jr., J. Lewis, J.P. McMillan, R.A. Pollard and P.A. Blake. 1983. Ciguatera fish poisioning: a major common source outbreak in the U.S. Virgin Islands. Ann. Intern. Med. 98:336-337.

3. Liston, J. 1990. Microbial hazards of seafood consumption. Food Technol. 44(12):56, 58-62.

4. Morris, J.G., Jr. 1988. Vibrio vulnificus: A new monster of the deep? Ann. Intern. Med. 109:261-263.

5. Taylor, S.L. 1986. Histamine food poisioning: Toxicology and clinical aspects. C.R.C. Crit. Rev. Toxicol. 17:91-128.

    3-201.15   Molluscan Shellfish.*

1. Food and Drug Administration, 1997. National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish. Public Health Service, Washington, DC.

2. Guzewich, J.J. and D.L. Morse, 1986. Sources of shellfish in outbreaks of probable viral gastroenteritis: Implications for control. J. Food Prot. 49:389-394.

3. Sobsey, M.D., C.R. Hackney, R.J. Carrick, B. Ray and M.C. Speck, 1980. Occurrence of enteric bacteria and viruses in oysters. J. Food Prot. 43:111-128.

    3-201.16   Wild Mushrooms.*

1. Ammirati, J.F. et al., 1985. Poisonous Mushrooms of the Northern United States and Canada, University of Minnesota Press, Minneapolis, MN.

2. Associated Press, 1997 Cable News Network, Inc. CNN report: poisonous mushrooms kill Sebastiani wine family member, January 16, 1997.

3. Baltimore Sun Newspaper via Associated Press, February 9, 1996 report on girl who picked deadly mushrooms with family gets liver transplant.

4. Chang, S.T. and W.A. Hayes, 1978. The Biology and Cultivation of Edible Mushrooms, Academic Press, New York. 819 pp.

5. Food and Drug Administration, 1987. Food Supplies - Wild mushrooms (6/11/87). Retail Food Protection Program Information Manual.

6. Gecan, J.S., and S.M. Cichowicz. 1993. Toxic mushroom contamination of wild mushrooms in commercial distribution. J. Food Prot. 56(8):730-734.

7. Hoard, R. and K. Hoard, 1980. Poisonous Hallucinogenic Mushrooms, 2nd Ed., Homestead Books, Brookfield, NY. 164 pp.

8. Lincoff, G. and D. Mitchel, 1977. Toxic and Hallucinogenic Mushroom Poisoning, Van Nostrand Reinhold Company, New York, 267 pp.

    3-201.17   Game Animals.*

1. Code of Federal Regulations, Title 50, Part 17 Endangered and Threatened Wildlife and Plants.

2. Codex Alimentarius Commission, 1993. Draft Revised Code of Hygienic Practice for Game (April 1993). Alinorm 93/16A, Appendix IV, pp. 119-149.

3. Federal Food, Drug, and Cosmetic Act, as Amended. 21 U.S.C. 201 et seq.

4. Federal Meat Inspection Act. 21 U.S.C. 601 et seq.

5. Hogue, A.T., D.W. Dreesen, S.S. Greene, A.D. Ragland, W.O. James, E.A. Bereron, L.V. Cook, M.D. Pratt, and D.R. Martin, 1993. Bacteria on beef briskets and ground beef: correlation with slaughter volume and antemortem condemnation. J. Food Prot. 56(2): 110-113, 119.

6. Poultry Products Inspection Act. 21 U.S.C. 451 et seq.

    3-202.11   Temperature.*

1. Code of Federal Regulations, Title 9, Part 590.50, Temperature and Labeling Requirements.

2. Humphrey, T.J., 1994. Contamination of egg shell and contents with Salmonella enteriditis: a review. International Journal of Food Microbiology, 21(1994) 31-40.

3.Mishu, B., J. Koehler, L. Lee, D. Rodrigue, F. Hickman Brenner, P. Blake, and R. Tauxe, 1994. Outbreaks of Salmonella enteritidis infections in the United States, 1985-1991. J. Infect. Dis. 169:547-552.

4. Rosenow, E.M. and E.H. Marth, 1987. Growth of Listeria monocytogenes in skim, whole and chocolate milk, and in whipping cream during incubation at 4,8,13,21 and 35° C. J. Food Prot. 50:452-259.

5. St. Louis, M.E., D.L. Morse, M.E. Potter, et al., 1988. The emergence of Grade A eggs as a major source of Salmonella enteritidis infections: New implications for the control of salmonellosis. J. Am. Med. Assoc. 259:2103-2107.

    3-202.12   Additives.*

1. Barlett, P.A., J.G. Morrie, Jr., and J. Spengler, 1982. Foodborne illness associated with niacin: Report of an outbreak linked to excessive niacin in enriched cornmeal. Public Health Rep. 97:258-260.

2. Food and Drug Administration, 1987. Food Supplies - Sulfiting agents on food in retail food establishments (9/10/87). Retail Food Protection Program Information Manual.

    3-202.13   Shell Eggs.*

1. Code of Federal Regulations, Title 7, Part 56, Voluntary Grading of Shell Eggs and AMS 56.200 et seq. United States Standards, Grades, and Weight Classes for Shell Eggs.

2. Code of Federal Regulations, Title 9, Part 590, Inspection of Eggs and Egg Products.

3. Bradshaw, J.G., D.B. Shah, E. Forney, and J.M. Madden, 1990. Growth of Salmonella enteritidis in yolk of shell eggs from normal and seropositive hens. J. Food Prot. 53 (12):1033-1036.

4. Centers for Disease Control, 1988. Update: Salmonella enteritidis infections and Grade A shell eggs - United States. Morb. Mortal. Wkly. Rep. 37:490-496.

5. Gast, R.K. and C.W. Beard, 1990. Production of Salmonella enteritidis - contaminated eggs by experimentally infected hens. Avian Dis. 34:438-446.

6. Kim, C.J., D.A. Emery, H. Rinkle, K.V. Nagaraja, and D.A. Halvorson. 1989. Effect of time and temperature on growth of Salmonella enteritidis in experimentally inoculated eggs. Avian Dis. 33:735-742.

7. St. Louis, M.E., D.L. Morse, E. Potter, T.M. DeMelfi, J.J. Guzewich, R.V. Tauxe, and P.A. Blake. 1988. The emergence of Grade A eggs as a major source of Salmonella enteritidis infections. J. Am. Med. Assoc. 259:2103-2107.

    3-202.14   Eggs and Milk Products, Pasteurized.*

1. Baker, R.C., S. Hogarty, W. Poon et al., 1983. Survival of Salmonella typhimurium and Staphylococcus aureus in eggs cooked by different methods. Poultry Sci. 62:1211-1216.

2. Cunningham, F.E., 1977. Egg pasteurization, in Egg Science and Technology, 2nd Ed., J. Stadelman, and O.J. Cotterill (Eds.), AVI Publishing Company, Inc., Westport, CT. pp. 161-186.

3. Code of Federal Regulations, Title 9, Part 590, Inspection of Eggs and Egg Products.

4. Doyle, M.P., L.M. Meske and E.H. Marth, 1985. Survival of Listeria monocytogenes during the manufacture and storage of nonfat dry milk. J. Food Prot. 48(9):740.

5. Food and Drug Administration, 1997. Grade "A" Pasteurized Milk Ordinance. Public Health Service, Washington, DC.

6. Tacket, C.O., L.B. Dominguez, H.J. Fisher and M.L. Cohen, 1985. An outbreak of multiple-drug-resistant Salmonella Enteritis from raw milk. J. Am. Med. Assoc. 253:2058-2060.

    3-202.16   Ice.*

1. Cliver, D.O., 1988. Virus transmission via foods; A scientific status summary by the Institute of Food Technologists' Expert Panel on Food Safety and Nutrition. Food Technol. 42(10):241-248.

2. Jackson, G.L., 1990. Parasitic protozoa and worms relevant to the U.S. Food Technol. 44(5):106-112.

    3-202.17   Shucked Shellfish, Packaging and Identification.

1. Food and Drug Administration, 1997. National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish. Public Health Service, Washington DC.

    3-202.18    Shellstock Identification.*

    3-202.19   Shellstock, Condition.

1. Code of Federal Regulations, Title 21, Part 1240, Control of Communicable Disease.

2. Food and Drug Administration, 1997. National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish. Public Health Service, Washington, D.C.

3. Freudenthal, A.R. and J.L. Jijina. 1988. Potential hazards of Dinophysis to consumers and shellfisheries. J. Shellfish Res. 7:695-701.

4. Klontz, K.C., S. Lieb, M. Schreider, H.T. Janowski, L.M. Baldy and R.A. Gunn. 1988. Syndromes of Vibrio vulnificus infections: clinical and epidemiological features in Florida cases 1981-1987. Ann. Intern. Med. 109:318-323.

5. Morse, D.L., J.J. Guzewich, J.P. Hanrahan, R. Stricot, M. Shayegani, R. Deible, J.C. Grabau, N.A. Nowak, J.E. Herrman, G. Cukor and N.R. Blacklow. 1986. Widespread outbreaks of clam and oyster associated gastroenteritis: Role of Norwalk virus. N. Engl. J. Med. 314:678-681.

6. Nishitani, L. and K. Chew. 1988. PSP toxins in Pacific Coast states: monitoring programs and effects on bivalve industries. J. Shellfish Res. 1:653-669.

7. Rippey, S.R., 1994. Seafood Borne Disease Outbreaks. U.S.Department of Health & Human Services, Public Health Service, Food and Drug Administration, Office of Seafood,

82 pp.

    3-203.11    Molluscan Shellfish, Original Container.

1. Food and Drug Administration, 1983. Food Supplies - Special requirements for retaining shell-stock "tags". (3/29/83), Retail Food Protection Program Information Manual.

    3-203.12    Shellstock, Maintaining Identification.*

1. Colburn, K.G., C.A. Kaysner, M.M. Wekell, J.R. Matches, C. Abeyta, Jr. and R.F. Stott, 1989. Microbiological quality of oysters (Crassostrea gigas) and water of live holding tanks in Seattle, WA markets. J. Food Prot. 52(2):100-104.

2. Food and Drug Administration, 1997. National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, Washington, D.C.

    3-301.11   Preventing Contamination from Hands.*

1. Bidawid, S., Farber, J.M., and Sattar, S.A. 2000. Contamination of Foods by Food Handlers: Experiments on Hepatitis A Virus Transfer to Food and Its Interruption. Applied Env. Micro. 66(7): 2759-2763.

2. Black, R.E., A.C. Dykes, K.E. Anderson et al., 1981. Hand washing to prevent diarrhea in day care centers. Am. J. Epidemiol. 113:445-451.

3. Cliver, D. O., and Kostenbader, K. D., 1984. Disinfection of virus on hands for prevention of food-borne disease. Intern. J. Food Microbiol., Vol. 1, pp.75-87.

4. Crisley, F.D. and M.J. Foter. 1965. The use of antimicrobial soaps and detergents for hand washing in food service establishments. J. Milk Food Technol. 28:278-284.

5. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 2000. Hepatitis A virus, in Bad Bug Book, Foodborne Pathogenic Microorganisms and Natural Toxins Handbook.

6. Goldmann, D.A., 1991. The role of barrier precautions in infection control. J. Hosp. Infect., Vol. 18, (Supplement A), pp. 515-523.

7. Goldmann, D.A., and Larson, E. 1992. Handwashing and nosocomial infections. New Eng. J. Med., Vol. 327, No.2. pp. 120-122.

8. Horwood, M.P. and V.A. Minch, 1951. The numbers and types of bacteria found on the hands of food handlers. Food Res. 16:133-136.

9. Humphrey, T.J., K.W. Martin, and A. Whitehead. 1994. Contamination of hands and work surfaces with Salmonella enteritidis PT4 during the preparation of egg dishes. Epidemiol. Infect. 113: 403-409.

10. Kaferstein, F.K., Motarjemi, Y., and Bettcher, D.W. 1997. Foodborne disease control: A transnational challenge, Emerg. Infect. Dis., Vol. 3, No. 4, pp. 503-511.

11. Lowbury, E.J.L., H.A. Lilly and J.P. Bull, 1964. Disinfection of hands: Removal of transient organisms. Brit. Med. J. 2:230-233.

12. Mead, P.S., Slutsker, L., Dietz, V., McCraig, L.F., Bresee, J.S., Shapiro, C., Griffin, P.M., Tauxe, R.V., 1999. Food-related illness and death in the United States. Emerg. Infect. Dis. Vol. 5, No.5, pp.38, in: http://www.cdc.gov/ncidod/EID/vol5no5/mead.htm.

13. Paulson, D.S., 1992. Evaluation of three handwashing modalities commonly employed in the food processing industry. Dairy Food Environ. Sanit. 12(10):615-618.

14. Pether, J.V.S. and R.J. Gilbert, 1971. The survival of salmonellas on finger-tips and transfer of the organisms to foods. J. Hyg. Camb. 69:673-681.

15. Rose, J.B., and Slifko, T.R., 1999. Giardia, Cryptosporidium, and Cyclospora and their impact on foods: a review. J. Food Protect. Vol. 62., No. 9, pp. 1059-1070.

16. Ross, M., and Guzewich, J., 1999. Evaluation of risks related to microbiological contamination of ready-to-eat food by food preparation workers and the effectiveness of interventions to minimize those risks. FDA White Paper, FDA, CFSAN.

17. Smith, J.L., 1993. Cryptosporidium and Giardia as agents of foodborne disease. J. Food Protection. Vol. 56: 451-461.

18. Williams, R.E.O., 1963. Healthy carriage of Staphylococcus aureus: Its prevalence and importance. Bacteriol. Rev. 27:56-71.

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

1. Code of Federal Regulations, Title 21, Part 109, Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material.

2. Dickson, J.S., 1990. Survival and growth of Listeria monocytogenes on beef tissue surfaces as affected by simulated processing conditions. J. Food Safety 10:165-174.

3. Doyle, M.P. and J.L. Schoeni, 1987. Isolation of Escherichia coli O157:H7 from retail fresh meats and poultry. Appl. Environ. Microbiol. 53:2394-2396.

4. Stern, N.J., M.P. Hernandez, L. Blankenship, K.E. Deibel, S. Doors, M.P. Doyle, H. Ng, M.D. Pierson, J.N. Sofos, H. Sveum and D.C. Westhoff, 1985. Prevalence and distribution of Campylobacter jejuni and Campylobacter coli in retail meats. J. Food Prot. 48(7):595-599.

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

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

1. Cunningham, F.E., 1977. Egg pasteurization, in Egg Science and Technology, 2nd Ed., J. Stadelman, and O.J. Cotterill (Eds.), AVI Publishing Company, Inc., Westport, CT. pp 161-186.

2. USDA/ARS. 1969. Egg Pasteurization Manual (ARS 74-48), USDA/ARS Albany, CA 94710. 47 pp.

    3-302.14   Protection from Unapproved Additives.*

    3-302.15   Washing Fruits and Vegetables.

1. Beuchat, L. 1998. Food Safety Issues. Surface Decontamination of Fruits and Vegetables Eaten Raw: A Review. World Health Organization. 42 pp.

2. Chia-Min, Lin, Cheng-I Wei*, 1997. Transfer of Salmonella montevideo onto the Interior Surfaces of Tomatoes by Cutting. J. Food Prot. 60(7): 858-863.

3. Geldreich, E.E. and R.H. Bordner, 1971. Fecal contamination of fruits and vegetables during cultivation and processing for market. J. Milk Food Technol. 34:184-195.

4. Heisick, J.E., D.E. Wagner, M.L. Nierman and J.T. Peeler, 1989. Listeria spp. found in fresh market produce. Appl. Environ. Microbiol. 55(8):1925-1927.

5. Madden, J.M., 1992. Microbial pathogens in fresh produce - the regulatory perspective. J. Food Prot. 55(10):821-823.

6. Satchell, F.B., P. Stevenson, W.H. Andrews, L. Estela and G. Allen, 1990. The survival of Shigella sonnei in shredded cabbage. J. Food Prot. 53:558-562.

7. Steinbrugge, E.S., R.B. Maxcy and M.B. Liewen, 1988. Fate of Listeria monocytogenes on ready-to-serve lettuce. J. Food Prot. 51:596-599.

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

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

1. Andrews, W.H., C.R. Wilson, P.L. Poelma and A. Romero, 1977. Bacteriological survey of channel catfish Ictalurus punctatus at the retail level. J. Food Sci. 42:359-364.

    3-304.11   Food Contact with Equipment and Utensils.*

1. Chia-Min, Lin, Cheng-I Wei*, 1997. Transfer of Salmonella montevideo onto the Interior Surfaces of Tomatoes by Cutting, J. Food Prot. 60(7): 858-863.

2. Escartin, E.F., A.C. Ayala and J.S. Lozano, 1989. Survival and growth of Salmonella and Shigella on sliced fresh fruit. J. Food Prot. 52(7):471-472.

3. Golden, G.A., E.J. Rhodehamel and D.A. Kautter, 1993. Growth of Salmonella spp.

in cantaloupe, watermelon, and honeydew melons. J. Food Prot. 56(3):194-196.

4. Humphrey, T.J., K.W. Martin, and A. Whitehead. 1994. Contamination of hands and work surfaces with Salmonella enteritidis PT4 during the preparation of egg dishes. Epidemiol. Infect. 113: 403-409.

5. Kim, H.U. and J.M. Goepfert, 1971. Occurrence of Bacillus cereus in selected dry food products. J. Milk Food Technol. 34:12-15.

6. Lopes, J.A., 1986. Evaluation of dairy and food plant sanitizers against Salmonella typhimurium and Listeria monocytogenes. J. Dairy Sci. 69:2791-2796.

7. Reida, P., M. Wolff, H.W. Pohls, W. Kuhlmann, A. Legnacher, S. Aleksic, H. Karch, J. Bockemuh. 1994. An Outbreak Due to Enterohemorrhagic Escherichia coli O157/H7 in a Children Day-Care-Center Characterized by Person-to-Person Transmission and Environmental Contamination. Zentralblatt Fur Bakteriologie-International, Int. J. Med. Micro. Vir. Para. Infect. Dis. 28(4): 534-543.

8. Scott, Elizabeth, and Sally F. Bloomfield. 1990. The Survival and Transfer of Microbial Contamination via Cloths, Hands, and Utensils. J. Appl. Bacteriol. 68: 271-278.

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

1. Food and Drug Administration, 1984. Food Preparation - Between-use storage of food preparation utensils (5/14/84). Retail Food Protection Program Information Manual.

    3-304.14   Wiping Cloths, Limitation.

1. Scott, Elizabeth and Sally F. Bloomfield. 1990. Investigations of the effectiveness of detergent washing, drying and chemical disinfection on contamination of cleaning cloths. J. Appl. Bacteriol. 68: 279-283.

2. Scott, Elizabeth and Sally F. Bloomfield. 1990. The Survival and Transfer of Microbial Contamination via Cloths, Hands and Utensils. J. Appl. Bacteriol. 68: 271-278.

    3-304.15   Gloves, Use Limitation.

1. Beezhold, Donald H., David A. Kostyal, and Jeffrey Wiseman. March 1994. The Transfer of Protein Allergens From Latex Gloves. AORN J. 59(3): 605-613.

2. Reddy, Sumana, M.D. January 1, 1998. Latex Allergy. Am. Fam. Phys. 57(1): 93-100.

3. Schwartz, Howard J., 1995, Latex: A potential hidden "food" allergen in fast food restaurants, J. Allergy Clin. Immunol. 95: 139-140.

4. Tomazic, Vesna J., Eric L. Shampaine, Anthony Lamanna, Thomas J. Withrow, Franklin N. Adkinson, Jr., and Robert G. Hamilton. April, 1994. Cornstarch Powder on Latex Products is an Allergen Carrier, J. Allergy Clin. Immunol. 93(4): 751-758.

    3-304.17   Refilling Returnables.

1. Food and Drug Administration, 1985. Food Protection - Refilling of take-home beverage containers (8/29/85). Retail Food Protection Program Information Manual.

    3-306.13   Consumer Self-Service Operations.*

1. Food and Drug Administration, 1984. Food Protection - Customer self-service of bulk food (4/16/84). Retail Food Protection Program Information Manual.

    3-401.11   Raw Animal Foods.*

1. Baker, R.C., 1990. Survival of Salmonella enteritidis on and in shelled eggs, liquid eggs, and cooked egg products. Dairy Food Environ. Sanit. 10(5):273-275.

2. Blankenship, L.E. and S.E. Craven, 1982. Campylobacter jejuni survival in chicken meat as a function of temperature. Appl. Environ. Microbiol. 44(1):88-92.

3. Bryan, F.L. and T.W. McKinley, 1979. Hazard analysis and control of roast beef preparation in foodservice establishments. J. Fod Prot. 42(1):4-18.

4. Castellani, A.G., R.R. Clark, M.I. Gibson and D. F. Meisner, 1952. Roasting time and temperature required to kill food poisoning microorganisms introduced experimentally into stuffing in turkeys, Food Res. 18:131-138.

5. Centers for Disease Control, 1993. Update: Multistate outbreak of Escherichia coli O157:H7 infections from hamburgers - western United States, 1992, 1993. Morb. Mortal. Wkly. Rep. 42 (14):258-263.

6. Code of Federal Regulations, Title 9, Part 318.10 (311 KB), Prescribed Treatment of Pork and Products Containing Pork to Destroy Trichinae.

7. Doyle, M.P. and J.L. Schoeni, 1984. Survival and growth characteristics of Escherichia coli associated with hemorrhagic colitis. Appl. Environ. Microbiol. 48 (4):855-856.

8. Dubey, J.P., A.W. Kotula, A. Sharar, C.D. Andrews, and D.S. Lindsay, 1990. Effect of high temperature on infectivity of Toxoplasma gondii tissue cysts in pork. J. Parasitol., 76 (2):201-204.

9. Dubey, J.P., 1998. Toxoplasma gondii Oocysts Survival under Defined Temperatures. J. Parasitol. 84(4):862-865.

10. Goodfellow, S.J. and W.L. Brown, 1978. Fate of Salmonella inoculated into beef for cooking. J. Food Prot. 41(8):598-605.

11. Hague, M.A., K.E. Warren, M.C. Hunt, D.H. Kropf, C.L. Kastner, S.L. Stroda, and D.E. Johnson, 1994. Endpoint Temperature, Internal Cooked Color, and Expressible Juice Color Relationships in Ground Beef Patties, J. Food Sci. 59(3):465-470.

12. Kotula, A.W., K.D. Murell, L. Acosta-Stein and L. Lamb, 1983. Trichinella spiralis: Effect of high temperature on infectivity in pork. Exp. Parasitol. 56:15-19.

13. Line, J.E., A.R. Fain, Jr., A.B. Moran, L.M. Martin, R.V. Lechowich, J.M. Carosella and W.L. Brown, 1991. Lethality of heat to Escherichia coli O157:H7: D-value and Z-value determinations in ground beef. J. Food Prot. 54 (10):62-766.

14. Shah, D.B., J.G. Bradshaw and J.T. Peeler. 1991. Thermal resistance of egg-associated epidemic strains of Salmonella enteritidis. J. Food Sci. 56:391-393.

15. Smith, J.L., 1994. Taenia solium neurocysticercosis. J. Food Prot. 57(9): 831-844.

16. Smith, J.L., 1992. Toxoplasma gondii in meats - a matter of concern? Dairy Food Environ. Sanit. 12(6):341-345.

17. Ward, D.R. and C.R. Hackney, 1991. Microbiology of Marine Food Products. Van Nostrand Reinhold, New York. 212 pp.

18. Webster, R.C. and W.B. Esselen, 1956. Thermal resistance of food poisoning microorganisms in poultry stuffing. J. Milk Food Technol. 19:209-212.

    3-401.12   Microwave Cooking.*

1. Aleixa, J.A.G., B. Swaminathan, K.S. Jamesen and D.E. Pratt, 1985. Destruction of pathogenic bacteria in turkeys roasted in microwave ovens. J. Food Sci. 50:873-875, 880.

2. Czechowicz, S.M. 1996. Destruction of Escherichia coli O157:H7 in food and Non-Food Systems by Microwaves. Ph.D. Thesis. University of Minnesota. 241 pages.

3. Craven, S.E. and H.S. Lillard, 1974. Effect of microwave heating of precooked chicken on Clostridium perfringens. J. Food Sci. 39:211-212.

4. Dahl, C.A., M.E. Matthews and E.H. Marth, 1980. Fate of Staphylococcus aureus in beef loaf, potatoes and frozen and canned green beans after microwave heating in a simulated cook/chill hospital food service system. J. Food Prot. 43:916-923.

5. Heddleson, R.A. and S. Doores, 1993. Factors Affecting Microwave Heating of Foods and Microwave Induced Destruction of Food Pathogens - A Review. J. Food Prot. 57(11)1025-1037.

6. Heddleson, R.A., S. Doores, R.C. Anantheswaran, and G.D. Kuhn, 1993. Viability Loss of Salmonella Species, Staphylococcus aureus, and Listeria monocytogenes in Complex Foods Heated by Microwave Energy. J. Food Prot. 59(8)813-818.

7. Sawyer, C.A., S.A. Biglari, and S.S. Thompson, 1984. Internal end temperature and survival of bacteria on meats with and without a polyvinylidene chloride wrap during microwave cooking. J. Food Sci. 49(3):972-973.

8. Sawyer, C.A., 1985. Post-processing temperature rise in foods: Hot air and microwave ovens. J. Food Prot. 48(5):429-434.

    3-402.11   Parasite Destruction.*

1. Bier, J.W. 1976. Experimental Anisakiasis: Cultivation and Temperature Tolerance Determinations. J. Milk Food Technol. 39:132-137.

2. Deardorff, T.L., R.B. Raybourne, R.S. Desowitz, 1986. Behavior and viability of third stage larvae of Terranova (HA) and Anasakis simplex (Type 1) under coolant conditions. J.Food Prot. 47:49-52.

3. Deardorff, T.L. and R. Throm, 1988. Commercial blast-freezing kills third stage larvae of Anisakis simplex encapsulated in salmon and rockfish. J. Parasitol. 74:233-250.

4. Food and Drug Administration, 1987. Food Preparation - Raw, marinated or partially cooked fishery products. Retail Food Protection Program Information Manual (8/21/87).

5. Food and Drug Administration, 1998. Fish and Fishery Products Hazards and Controls Guide, Office of Seafood. 276 pp.

6. Gustafson, P.V. 1953. The effect of freezing on encysted Anisakis larvae. J. Parasitol. 39:585-588.

7. Haigashi, G.I., 1985. Foodborne parasites transmitted to man from fish and other aquatic foods. Food Technol. 39(3):69-74.

8. Jackson, G.L., 1990. Parasitic protozoa and worms relevant to the U.S. Food Technol. 44(5):106-112.

9. Kaneko, J., and P. Bartram, 1994. A position paper dated May 25, 1994 submitted to Dockets Management Branch, U.S. Food and Drug Administration in response to the proposed FDA HACCP program for seafood. See Part 4: Critical Review of FDA Position on Parasite Hazards in Tuna.

10. Ronald, K., 1960. The effects of physical stimuli on larval stages of Terranova decipiens. Can. J. Zool. 38:623-642.

11. Ruitenberg, E.J., 1970. Anisakiasis: Pathogenesis, Serodiagnosis and Control. University of Utrecht, Netherlands. 138 pp.

    3-402.12   Records, Creation, and Retention.

    3-403.11   Reheating for Hot Holding.*

1. Bennett, R.W. and M.R. Berry, 1987. Serological activity and in vitro toxicity of Staphylococcus aureus enterotoxins A and D in selected canned foods. J. Food Sci. 52:416-418.

2. Bradshaw, J.G., J.T. Peeler and R.M. Twedt, 1979. Thermal inactivation of Clostridium botulinum toxins types A and B in buffer, and beef and mushroom patties. J. Food Sci. 44(6):1653-1657.

3. Craven, S.E., 1980. Growth and sporulation of Clostridium perfringens in foods. Food Technol. 34(4):80-87.

4. Food Refrigeration & Process Engineering Research Centre, reporting period 1 March 95 to 1 August 96. Determination of unsatisfactory temperature distributions within foods heated in microwave ovens. Measurement and Testing Programme (MTP), Framework 3, Part 2, contract number MATI-CT 940014, University of Bristol, UK.

5. Heddleson, R.A., S. Doores, R.C. Anantheswaran, and G.D. Kuhn, 1993. Viability Loss of Salmonella Species, Staphylococcus aureus, and Listeria monocytogenes in Complex Foods Heated by Microwave Energy. J. Food Prot. 59(8)813-818.

6. Johnson, K.M., C.L. Nelson and F.F. Busta, 1983. Influence of temperature on germination and growth of spores of emetic and diarrheal strains of Bacillus cereus in growth medium and in rice. J. Food Sci. 48:286-287.

7. Licciardello, J.J., C.A. Ribich, J.T.R. Nickerson and S.A. Goldblith, 1967. Kinetics of the thermal inactivation of type E Clostridium botulinum toxin. Appl. Microbiol. 15(2):344-349.

8. Roy, R.J., F.F. Busta and D.R. Thompson, 1981. Thermal inactivation of Clostridium perfringens after growth at several constant and linearly rising temperatures. J. Food Sci. 46:1586-1591.

9. Woodburn, M.J., E. Somers, J. Rodriguez and E.J. Schantz, 1979. Heat inactivation rates of botulism toxin A, B, E, and F in some foods and buffers. J. Food Sci. 44:1658-1661.

    3-501.11   Frozen Food.

    3-501.12   Potentially Hazardous Food, Slacking.

    3-501.13   Thawing.

1. Bryan, F.L. and T.W. McKinley, 1974. Prevention of foodborne illness by time-temperature control of thawing, cooking, chilling and reheating of turkeys in school lunch kitchens. J. Milk Food Technol. 37:420-429.

    3-501.14   Cooling.*

1. Blankenship, L.C., S.E. Craven, R.G. Leffler and C. Custer, 1988. Growth of Clostridium perfringens in cooked chili during cooling. Appl. Environ. Microbiol. 54(5):1104-1108.

2. Bryan, F.L., 1974. Identifying Foodborne Disease Hazards in Food Service Establishments. J. Environ. Health 36(6):537-540.

3. Bryan, F.L., 1979. Prevention of Foodborne Diseases in Food Service Establishments. J. Environ. Health 41(4):198-206.

4. Dickerson, R.W., Jr. and R.B. Read, Jr., 1973. Cooling rates of foods. J. Milk Food Technol. 36(3):167-171.

5. Juneja, V.K., O.P. Snyder, Jr., and M. Cygnarowicz-Provost. 1994. Influence of cooling rate on outgrowth of Clostridium perfringens spores in cooked ground beef. J. Food Prot. 57:(12):1063-1067.

6. Lewis, M.N., H.H. Weisner and A.R. Winter, 1953. Bacterial growth in chicken salad. J. Am. Diet. Assoc. 29:1094-1099.

7. Longrée, K. and J.C. White, 1955. Cooling rates and bacterial growth in food prepared and stored in quantity. I. Broth and white sauce. J. Am. Diet. Assoc. 31:124-132.

8. USDA. 1999. Performance Standards for the Production of Certain Meat and Poultry Products. Federal Register, 64:(3):732-749.

    3-501.15    Cooling Methods.

1. Bryan, F.L., 1990. Application of HACCP to ready-to-eat chilled foods. Food Technol. 45(7):7077.

2. Rollin, J.L. and M.E. Matthews, 1977. Cook-chill foodservice systems: Temperature histories of a cooked beef product during the chilling process. J. Food Prot. 40:782-784.

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

(See Supplement) 

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. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

    3-501.17   Ready-to-Eat, Potentially Hazardous Food, Date Marking.*

    3-501.18   Ready-to-Eat, Potentially Hazardous Food, Disposition.*

1. Palumbo, S.A., 1986. Is refrigeration enough to restrain foodborne pathogens? J. Food Prot. 49(12):1003-1009.

2. Rosso, L., Bajard, S. Flandrois, J.P. Lahellec, C., Fournaud, J. and Veit, P., 1996. Differential Growth of Listeria monocytogenes at 4 and 8°C: Consequences for the Shelf Life of Chilled Products, J. Food Prot. 59:944-949.

3. Steinbruegge, E.D., R.B. Maxcy and M.B. Liewen, 1988. Fate of Listeria monocytogenes on ready to serve lettuce. J. Food Prot. 51:596-599.

4. USDA ARS Eastern Regional Research Center, Pathogen Modeling Program, Version 4.0, 1994. Microbial Food Safety Research Unit, Philadelphia, PA.

    3-501.19   Time as a Public Health Control.*

1. Bryan, F. L. and E. G. Kilpatrick. 1971. Clostridium perfringens related to roast beef cooking, storage and contamination in a fast food service restaurant. Am. J. of Public Health. 61 (9): 1869-1885.

2. Doan, C. H. and P. M. Davidson, 1999. Growth of Bacillus cereus on Oil-Blanched Potato Strips for "Home-Style" French Fries. J. Food Sci. 64:909-912.

3. Doan, C. H. and P. M. Davidson, 1999. Growth and Production of Enterotoxin A by Staphylococcus aureus on "Home-Style" French Fries. J. Food Sci. 64:913-917.

4. Ferguson, R. D. and Shelef L.A. 1990. Growth of Listeria monocytogenes in soy milk. Food Micro. 7: 49-52.

5. ICMSF. 1996. Microorganisms in Foods 5. Characteristics of Microbial Pathogens. Chapter 2 Bacillus Cereus. P20-35. Blackie Academic & Professional, London.

6. ICMSF. 1996. Microorganisms in Foods 5. Characteristics of Microbial Pathogens. Chapter 6 Clostridium perfringens. P112-125. Blackie Academic & Professional, London.

7. Johnson, K.M., C.L. Nelson and F.F. Busta, 1983. Influence of temperature on germination and growth of spores of emetic and diarrheal strains of Bacillus cereus in growth medium and in rice. J. Food Sci. 48:286-287.

8. Mead, P.S., Slutsker, L., Dietz, V., McCaig, L.F., Bresee, J.S. Shapiro, C., Griffen,P. and R.V. Tauxe. 1999. Food related illness and death in the United States. Emerging Infectious Disease. 5 (5): 607-625.

9. Melling,J.and Capel, B.J., 1978. Characteristics of Bacillus cereus toxin. FEMS Micro Letters. 4:133-135.

10. Sionkowski, P.J. and Shelef, L.A. 1990. Viability of Listeria monocytogenes strain Brie-1 in the avian egg. J. Food Prot. 53 (1): 15-17.

11. Solomon, H.M. and D.A. Kautter, 1986. Growth and toxin production by Clostridium botulinum in sauteed onions. J. Food Prot. 49(10):618-620.

12. Solomon, H.M. and D.A. Kautter, 1988. Outgrowth and toxin production by Clostridium botulinum in bottled chopped garlic. J. Food Prot. 51(11):862-865.

13. Tatini, S.R., 1973. Influence of food environments on growth of Staphylococcus aureus and production of various enterotoxins. J. Milk Food Technol. 36(11):559-563.

14. United States Department of Agriculture Agricultural Research Service. Pathogen Modeling Program Version 5.1. www.arserrc.gov/mfs/.

    3-502.11   Variance Requirement.*

1. Barber, F.E. and R.H. Deibel, 1972. Effect of pH and oxygen tension on Staphylococcal growth and enterotoxin formation in fermented sausage. Appl. Microbiol. 24:891-898.

2. Dickerson, R.W. and R.B. Read. 1968. Calculations and measurement of heat transfer in foods. Food Technol. 22:1533.

3. Dickerson, R.W. and R.B. Read, 1973. Cooling rates in foods. J. Milk Food Technol. 36(3):167-171.

4. National Advisory Committee on Microbiological Criteria for Foods, 1992. Hazard analysis and critical control point system. Int. J. Food Microbiol. 16:1-23.

5. Pierson, M.D. and D. A. Corlett Jr. (Eds.) 1992. HACCP Principles and Applications. Van Nostrand Reinhold, New York. 212 pp.

6. Shigehisa, T., T. Nakagami and S. Taji, 1985. Influence of heating and cooling rates on spore germination and growth of Clostridium perfringens in media and in roast beef. Jpn. J. Vet. Sci. 47(2):259.

7. Snyder, O.P., Jr., 1986. Applying the Hazard Analysis and Critical Control Points system in foodservice and foodborne illness prevention. J. Foodservice Systems 4:125-131.

8. Sperber, W.H., 1982. Requirements of Clostridium botulinum for growth and toxin production. Food Technol. 36(12):89-94.

9. Tanaka, N., 1982. Challenge of pasteurized process cheese spreads with Clostridium botulinum using in-process and post-process inoculation, J. Food Prot. 45:1044-1050.

10. Troller, J.A., 1972. Effect of water activity on enterotoxin A production and growth of Staphylococcus aureus. Appl. Microbiol. 24(3):440-443.

    3-502.12   Reduced Oxygen Packaging, Criteria.*

  1. Association of Food and Drug Officials, 1990. Retail guidelines - Refrigerated foods in reduced oxygen packages. J. Assoc. Food Drug Offic. 54(5):80-84.
  2. Bennett, R.W. and W.T. Amos, 1982. Staphylococcus aureus growth and toxin production in nitrogen packed sandwiches. J. Food Prot. 45(2):157-161.
  3. Berrang, M.E., R.E. Brackett and L.R. Beuchat, 1989. Growth of Listeria monocytogenes on fresh vegetables under controlled atmosphere. J. Food Prot. 52:702-705.
  4. Code of Federal Regulations, Title 9, Part 424.21, Use of food ingredients and sources of radiation.
  5. Conner, D.E., V.N. Scott, D.T. Bernard and D.A. Kautter, 1989. Potential Clostridium botulinum hazards associated with extended shelf-life refrigerated foods: A review. J. Food Safety 10:131-153.
  6. Davis, H., J.P. Taylor, J.N. Perdue, G.N. Stelma, Jr., J.M. Humphreys, Jr., R. Roundtree III, and K.D. Greene, 1988. A shigellosis outbreak traced to commercially distributed shredded lettuce. Am. J. Epidemiol. 128(6):1312-1321.
  7. Gill, C.O. and K.M. Delacy, 1991. Growth of Escherichia coli and Salmonella typhimurium on high-pH beef packaged under vacuum or carbon dioxide. Int. J. Food Microbiol. 13:21-30.
  8. Grau, F.H. and P.B. Vanderline, 1990. Growth of Listeria monocytogenes on vacuum packaged beef. J. Food Prot. 53:739-741, 746.
  9. Juneja, Vijay, Stefan T. Martin and Gerald M. Sapers, 1998. Control of Listeria monocytogenes in Vacuum-Packaged Pre-Peeled Potatoes. J. Food Science 63(5):911-914.
  10. Kautter, D.A., 1964. Clostridium botulinum type E in smoked fish. J. Food Sci. 29:843-849.
  11. Marth, Elmer H., 1998. Extended Shelf Life Refrigerated Foods: Microbiological Quality and Safety. Food Technology 5(2):57-62.
  12. New York Department of Agriculture and Markets, 1993. Guidelines for Reduced Oxygen Packaging at Retail. Division of Food Safety and Inspection, 1 Winners Circle, Albany, NY 12235, 2 pp.
  13. Nolan, D.A., D.C. Chamblin, and J.A. Troller, 1992. Minimal water activity for growth and survival of Listeria monocytogenes and Listeria innocua. Int. J. Food Microbiol. 16:323-335.
  14. Refrigerated Foods and Microbiological Criteria Committee of the National Food Processors Association, 1988. Factors to be Considered in Establishing Good Manufacturing Practices for the Production of Refrigerated Foods. Dairy and Food Sanitation, 8(6):288-291.
  15. Refrigerated Foods and Microbiological Criteria Committee of the National Food Processors Association, 1988. Safety Considerations for New Generation Refrigerated Foods. Dairy and Food Sanitation, 8(1):5-7.

    3-601.11   Standards of Identity.

    3-601.12   Honestly Presented.

    3-602.11   Food Labels.

    3-602.12   Other Forms of Information.

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

1. Centers for Disease Control, 1993. Update: Multistate outbreak of Escherichia coli O157:H7 infections from hamburgers - western United States, 1992,1993. Morb. Mortal. Wkly. Rep. 42(14):258-263.

2. Morris, J.G., Jr. 1988. Vibrio vulnificus: A new monster of the deep? Ann. Intern. Med. 109:261-263.

3. Potter, M.E., A.F. Kauffmann, P.A. Blake and R.A. Feldman, 1984. Unpasteurized milk: The hazards of a health fetish. J. Am. Med. Assoc. 252:2048-2052.

4. St. Louis, M., et al. 1988. The emergence of Grade A eggs as a major source of Salmonella enteritidis infections. J. Am. Med. Assoc. 259:2103-2107.

5. Tacket, C.O., L.B. Dominguez, H.J. Fisher, and M.L. Cohen, 1985. An outbreak of multiple-drug-resistant Salmonella enteritidis from raw milk. J. Am. Med. Assoc. 253:2058-2060.

    3-801.11   Pasteurized Foods, Prohibited Reservice, and Prohibited Food.*

1. Besser, R.E., S.M. Lett, J.T. Webber, M.P. Doyle, T.J. Barrett, J.G. Wells, and P.M. Griffin, 1993. An Outbreak of Diarrhea and Hemolytic Uremic Syndrome From Escherichia coli O157H:7 in Fresh-Pressed Apple Cider. J. Am. Med. Assoc., 269(17):2217-2220.

2. Conner, D.E., and J.S. Kotrola. Growth and Survival of Escherichia coli O157H:7 under Acidic Conditions. Applied and Environmental Microbiology, January, 1995, pp. 382-385.

3. Goverd, K.A., F.W. Beech, R.P. Hobbs and R. Shannon, 1979. The occurrence and survival of coliforms and salmonellas in apple juice and cider. J. Appl. Bacteriol. 46:521-530.

4. Humphrey, T.J., K.W. Martin, and A. Whitehead. 1994. Contamination of hands and work surfaces with Salmonella enteritidis PT4 during the preparation of egg dishes. Epidemiol. Infect. 113: 403-409.

5. Miller, L.G., and C.W. Kaspar, 1994. Escherichia coli O157:H7 Acid Tolerance and Survival in Apple Cider. J. Food Pro. 57(6):460-464.

6. Zhao, T., M.P. Doyle and R.E. Besser, 1993. Fate of enterohemorrhagic Escherichia coli O157:H7 in apple cider with and without preservatives. Appl. Environ. Microbiol. 59(8): 2526-2530.

 

     Chapter 4 Equipment, Utensils, and Linens

 

    4-101.14   Copper, Use Limitation.*

1. Low, B.A., J.M. Donahue, and C.B. Bartley, 1996. FINAL REPORT - A STUDY ON BACKFLOW PREVENTION ASSOCIATED WITH CARBONATORS. NSF, International, Ann Arbor, MI. pp. 18-20.

2. Peterson, C.S., 1979. Microbiology of Food Fermentation, 2nd Ed. AVI Publishing Co., Inc., Westport, Connecticut, pp. 288-293.

    4-101.16   Sponges, Use Limitation.

1. Enriquez, C.E., R. Enriquez-Gordillo, D.I. Kennedy, and C.P. Gerba, January, 1997. Bacteriological Survey of Used Cellulose Sponges and Cotton Dishcloths from Domestic Kitchens. Dairy, Food and Environmental Sanitation, Vol. 17, No. 1, Pages 20-24.

    4-101.17   Lead in Pewter Alloys, Use Limitation.

1. American Society for Testing and Materials, 1992. Annual Book of ASTM Standards Volume 02.04. ASTM, Philadelphia, PA. 414-416.

    4-101.19   Wood, Use Limitation.

1. Abrishami, S.H., B.D. Tall, T.J. Bruursema, P.S. Epstein and D.B. Shah. Bacterial Adherence and Viability on Cutting Board Surfaces. Department of Microbiology, NSF International, Ann Arbor, MI and Division of Microbiological Studies, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, Washington, D.C. Journal of Food Safety 14 (1994) 153-172.

2. Agricultural Research Service, U.S. Department of Agriculture. ARS Affirms Plastic Cutting Board Policies. Food Chemical News, December 6, 1993, pp. 56-57.

    4-501.114   Manual and Mechanical Warewashing Equipment, Chemical Sanitization - Temperature, pH, Concentration, and Hardness.*

1. Miller, M.P., Principal Investigator, 1984. Relationship of Factors Affecting Bactericidal Effectiveness of Chlorine Sanitizing Solutions. Final Report. National Sanitation Foundation, Ann Arbor, MI., subcontract No. 9013-092-108-H0620-101; Booz, Allen & Hamilton, Inc. contract No. 223-80-2295.

2. Miller, M.P., Principal Investigator, 1985. Relationship of Factors Affecting Bactericidal Effectiveness of Chlorine Sanitizing Solutions. Addendum to Final Report. National Sanitation Foundation, Ann Arbor, MI., subcontract No. 9013-092-108-H0620-101; Booz, Allen & Hamilton, Inc. contract No. 223-80-2295.

3. National Sanitation Foundation, Ann Arbor, MI. November, 1990. Report on the Bacterial Effectiveness of a Chlorine Sanitizing Solution at Contact Times of Less than Ten Seconds. Purchase Order #FDA 665531-00-90-RB.

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

1. Tauxe, R.V., M.D., Chief, Foodborne and Diarrheal Diseases Branch, Division of Bacterial and Mycotic Diseases, National Center for Infectious Disease and M.L. Cohen, M.D., Director, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, memo dated January 10, 1996 re: "Bacterial Contamination of Iced Tea," to State and Territorial Epidemiologists and State and Territorial Public Health Laboratory Directors. Memo includes two fact sheets by the Tea Association of the U.S.A., Inc.

    4-603.17   Returnables, Cleaning for Refilling.*

1. Food and Drug Administration, 1985. Food Protection - Refilling of take-home beverage containers (8/29/85). Retail Food Protection Program Information Manual.

    4-703.11   Hot Water and Chemical.*

1. Miller, M.P., Principal Investigator, 1984. Relationship of Factors Affecting Bactericidal Effectiveness of Chlorine Sanitizing Solutions. Final Report. National Sanitation Foundation, Ann Arbor, MI., subcontract No. 9013-092-108-H0620-101; Booz, Allen & Hamilton, Inc. contract No. 223-80-2295.

2. Miller, M.P., Principal Investigator, 1985. Relationship of Factors Affecting Bactericidal Effectiveness of Chlorine Sanitizing Solutions. Addendum to Final Report. National Sanitation Foundation, Ann Arbor, MI., subcontract No. 9013-092-108-H0620-101; Booz, Allen & Hamilton, Inc. contract no. 223-80-2295.

3. National Sanitation Foundation, Ann Arbor, MI. November, 1990. Report on the Bacterial Effectiveness of a Chlorine Sanitizing Solution at Contact Times of Less than Ten Seconds. Purchase Order #FDA 665531-00-90-RB.

 

     Chapter 5 Water, Plumbing, and Waste

 

1. Building Officials and Code Administrators International, Inc. The BOCA National Plumbing Code/1993, Country Club Hills, IL. 110pp.

2. International Association of Plumbing and Mechanical Officials. Uniform Plumbing Code, 1994 Edition, Walnut, CA. 441pp.

3. National Association of Plumbing-Heating-Cooling Contractors. 1993 National Standard Plumbing Code - Illustrated, Falls Church, VA. 439pp.

4. Southern Building Code Congress International, Inc. 1994 Standard Plumbing Code and 1995 Revisions, Birmingham, AL. 296pp.

    5-202.12   Handwashing Facility, Installation.

1. American Society for Testing and Materials, Designation: E 1838-99, Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash Agents Using the Fingerpads of Adult Volunteers. ASTM, Philadelphia, PA.

2. American Society for Testing and Materials, Designation: E 2011-99, Standard Test Method for Evaluation of Handwashing Formulations for virus-Eliminating Activity Using the Entire Hand. ASTM, Philadelphia, PA.

3. American Society for Testing and Materials, Designation: E 1327-90 (reapproved 1995), Standard Test Method for Evaluation of Health Care Personnel Handwash Formulations by Utilizing Fingernail Regions. ASTM, Philadelphia, PA.

4. American Society for Testing and Materials, Designation: E 1174-87, Standard Test Method for Evaluation of Health Care Personnel Handwash Formulation. ASTM, Philadelphia, PA.

 

     Chapter 6 Physical Facilities

 

    6-202.15   Outer Openings, Protected.

1. National Fire Protection Association, "NFPA 101® Code for Safety to Life from Fire in Buildings and Structures, 1994 Edition."

2. National Fire Protection Association, "Handbook to the NFPA 101® Code for Safety to Life from Fire in Buildings and Structures, 1994 Edition."

    6-303.11   Intensity.

1. Illuminating Engineering Society of North America, 1993. Lighting Handbook, 8th Ed., IESNA Publications Dept., New York, NY. 900+pp.

 

3.     FDA SUPPORTING DOCUMENTS

FDA has developed and issued the following documents. A brief summary for each document is provided.

  1. (Draft) Recommended National Retail Food Regulatory Program Standards
  2. FDA Procedures for Standardization and Certification of Retail Food Inspection/Training Officers
  3. (Draft) Managing Food Safety: A HACCP Principles Guide for Operators of Food Service, Retail Food Stores, and Other Food Establishments at the Retail Level
  4. Food Establishment Plan Review Guidelines
  5. Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors

 A.   (Draft) Recommended National Retail Food Regulatory Program Standards

This document can be found at Draft Voluntary National Retail Food Regulatory Program Standards and was formulated from ideas and input by federal, state, and local regulatory officials, industry, trade and professional associations, academia, and consumers. The purposes of these standards are:

  • To serve as a bench mark to retail food regulatory program managers in the design and management of a retail food program;
  • To provide a means of recognition of programs meeting these standards;
  • To promote uniformity in retail food programs to reduce the risk factors known to cause foodborne illness;
  • To provide a foundation for the food regulatory program that is focused on the risk factors and other factors that may contribute to foodborne illness; and
  • To promote, through the management of a retail food regulatory program, the active managerial control in the retail establishment of all the factors that may cause foodborne illness.

Further purposes of these standards are to serve as a guide to regulatory retail food program managers in the design and management of a retail food program and to provide a means of recognition for those programs that meet these standards.

The intent in the development of these standards is to establish a basic foundation in design and management of a retail food program. Program management may add additional requirements to meet individual program needs.

The standards apply to the operation and management of a regulatory retail food program focused on the reduction of risk factors known to cause foodborne illness as well as other factors that may contribute to foodborne illness and on the promotion of active managerial control of all factors that may cause foodborne illness.

 B.   Procedures for Standardization and Certification of Retail Food Inspection/Training Officers

This document can be found at FDA Procedures for Standardization and Certification of Retail Food Inspection/Training Officers. This is a procedure that integrates the assessment of an individual's knowledge, skills, and abilities in a manageable number of inspections while preserving the quality and integrity of the process. At the same time, we continue to learn from our experiences in applying it and remain open to improving these Procedures based on your experiences and feedback.

As they are written, the Procedures address the situation wherein an FDA Standard is assessing a CANDIDATE who is not employed by FDA. For example, Paragraph 3-301(C) mentions but does not require recording citations (i.e., identifying the codified provision that relates to each observed violation). Since jurisdiction's codification systems (numeric or alphanumeric) are usually different from the system in the FDA Food Code, the utility of that practice would be minimal in an FDA-to-jurisdiction field exercise. However, within a jurisdiction where the same Code is in use, the practice could be useful in reinforcing diligence in ensuring that violations listed during inspections are, in fact, soundly based in regulation.

FDA invites and encourages jurisdictions to use these Procedures in their internal Standardization and Certifications and to add dimensions that promote uniformity such as citing codified provisions, as discussed above. With a few language changes, the document can be custom-tailored to fit individual jurisdictions and serve as their procedures. As with other documents provided as guidance for applying regulatory requirements in the retail sector, these Procedures are in the "public domain" and we encourage their duplication and use.

 C.   (Draft) Managing Food Safety: A HACCP Principles Guide for Operators of Food Service, Retail Food Stores, and Other Food Establishments at the Retail Level

This document can be found at FDA Managing Food Safety. FDA has issued guidance to industry in voluntarily applying HACCP principles in food establishments. It recognizes that there are differences between using HACCP at retail and in food manufacturing. By incorporating the seven principles of HACCP, a good set of Standard Operating Procedures, and using a process approach, this Guide sets up a framework for the retail food industry to develop and implement a sound food safety management system.

This document is intended to serve as a guide in the writing of a simple plan based on HACCP principles that can be used to manage food safety. It is very important to understand that this Guide is intended to assist industry's voluntary implementation of HACCP principles. It is not meant to stand alone, but instead should be used together with advice from and in consultation with your federal, state, local, or tribal food safety regulatory authority. The regulatory authority is an important resource for reviewing your food safety management system. Regulatory food safety professionals can provide important information for the public health rationale for controlling a particular hazard. Users of this document also need to consult and use the latest edition of the FDA Food Code since many of its requirements are not reproduced here but constitute a fundamental program that is prerequisite to implementing a HACCP program.

Hazard Analysis Critical Control Point (HACCP) is a common sense technique to control food safety hazards. It is a preventive system of hazard control rather than a reactive one. Food establishments can use it to ensure safer food products for consumers. It is not a zero risk system, but is designed to minimize the risk of food safety hazards. HACCP is not a stand alone program but is one part of a larger system of control procedures that must be in place in order for HACCP to function effectively. These control procedures are prerequisite programs and are discussed more in Chapter 4.

The success of a HACCP program is dependent upon both people and facilities.

Management and employees must be properly motivated and trained if a HACCP program is to successfully reduce the risk of foodborne illness. Education and training in the principles of food safety and management commitment to the implementation of a HACCP system are critical and must be continuously reinforced. Instilling food worker commitment and dealing with problems such as high employee turnover and communication barriers must be considered when designing a HACCP plan.

Successful implementation of a HACCP plan is also dependent upon the design and performance of facilities and equipment. The likelihood of the occurrence of a hazard in a finished product is definitely influenced by facility and equipment design, construction, and installation that play a key role in any preventive strategy.

The Agency recognizes that this document has areas that need to be further clarified and developed with broader input and based on industry's experiences with the practicalities of integrating the HACCP approach in their operations. This Guide will continue to evolve and improve.

 D.   Food Establishment Plan Review Guidelines

This document can be found at FOOD ESTABLISHMENT PLAN REVIEW GUIDE. This food establishment Plan Review document has been developed for the purpose of assisting both regulatory and industry personnel in achieving greater uniformity in the plan review process. It is the result of a joint effort by FDA and the Conference for Food Protection.

Plan review of food service establishments, retail food stores, and all other food operations, must be maintained as a high priority by all regulatory food agencies for both new and existing facilities.

This document has been developed to serve as a guide in facilitating greater uniformity and ease in conducting plan review whether your position is a regulator or an industry person wishing to build or to expand. You need not be an expert to effectively complete this process.

A good review of plans helps to avoid future problems. By listing and locating equipment on floor plans and diagramming specifications for electrical, mechanical and plumbing systems, potential problems can be spotted while still on paper and modifications made BEFORE costly purchases, installation and construction.

Food establishment plan review is recognized as an important food program component that allows:

--   Regulatory agencies to ensure that food establishments are built or renovated according to current regulations or rules.

--   Industry to establish an organized and efficient flow of food.

--   Regulatory agencies to eliminate code violations prior to construction.

 E.   Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors

This document can be found at Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors. The 1996 report "Reinventing Food Regulations" [National Performance Review] concluded that foodborne illness caused by harmful bacteria and other pathogenic microorganisms in meat, poultry, seafood, dairy products, and a host of other foods is a significant public health problem in the United States. For years regulatory and industry food safety programs have been designed to minimize the occurrence of foodborne illness. There is, however, a lack of a national baseline on the occurrence of foodborne disease risk factors.

This project is designed to establish a national baseline on the occurrence of foodborne disease risk factors within the retail segment of the food industry. This report presents the methodology used to establish a baseline and reports the results of the data collected. The report is provided to regulators and industry with the expectation that it will be used to focus greater attention and increased resources on the control of foodborne illness risk factors.

 


 *April 2004 Update: Editorial edits were made to the 2001 Food Code to incorporate the Errata Sheet, corrections since original posting date, and for content accuracy. Links were also added where references exist to other parts/sections of the Food Code, the Code of Federal Regulations, the United States Code, and the Supplement to the 2001 Food Code.