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Annex |
1. UNITED STATES CODE AND CODE OF FEDERAL REGULATIONS
2. BIBLIOGRAPHY
3. FDA SUPPORTING DOCUMENTS
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
(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
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.
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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, 21 U.S.C. General Authority, Section 704. 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.
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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 (3,231 KB) 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, 21 U.S.C. 201(s) and Code of Federal Regulations, and Title 21 Part 170 Food Additive.
10. Federal Food, Drug and Cosmetic Act, 21 U.S.C. 201(t) and Code of Federal Regulations, and Title 21 Part 70 Color Additive.
11. Federal Food, Drug and Cosmetic Act, 21 U.S.C. 402 Adulterated.
12. Federal Food, Drug and Cosmetic Act, 21 U.S.C. 721 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.
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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.
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.
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.
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,
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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.
Reserved.
1. Ojajarvi, J., 1980. Effectiveness of handwashing and disinfection methods in removing transient bacteria after patient nursing. J. Hyg. Camb. 85:193-203.
1. Code of Federal Regulations, Title 21, Part 178.1010 (579 KB) 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.
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.
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...."
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.
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Centers for Disease Control, 1987. International outbreak associated with ungutted, salted whitefish. Morb. Mortal. Wkly. Rep. 36:812-813.
Code of Federal Regulations, Title 21, Part 16, Regulatory Hearing Before the Food and Drug Administration
Code of Federal Regulations, Title 21, Part 101, Food Labeling
Code of Federal Regulations, Title 21, Part 115, Shell Eggs
Federal Register: (Volume 65, Number 234), Pages 76091-76114
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.
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.
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.
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.
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FDA has developed and issued the following documents. A brief summary for each document is provided.
(Draft) Recommended National Retail Food Regulatory Program Standards
FDA Procedures for Standardization and Certification of Retail Food Inspection/Training Officers
(Draft) Managing Food Safety: A HACCP Principles Guide for Operators of Food Service, Retail Food Stores, and Other Food Establishments at the Retail Level
Food Establishment Plan Review Guidelines
Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors
This document can be found at the web site http://www.cfsan.fda.gov/~dms/ret-toc.html 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:
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.
This document can be found at the web site http://www.cfsan.fda.gov/~ear/rfi-toc.html. 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.
This document can be found at the web site http://www.cfsan.fda.gov/~dms/hret-toc.html. 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.
This document can be found at the web site http://www.cfsan.fda.gov/~dms/previntr.html. 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.
This document can be found at the web site http://www.cfsan.fda.gov/~dms/retrsk.html. 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.
