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FDA 1997 Food Code - Summary of Changes

U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
1997 Food Code


 

Summary of Changes
in the FDA Food Code


 

This Summary provides a synopsis of the textual changes from the 1995 FDA Food Code Chapters and Annexes to the 1997 edition. The primary intent of this record is to capture the nature of the changes rather than to identify every word or editing change. This record should not be relied upon as an absolute comparison that identifies each and every change.

 

General:

  • Numerous editing changes were made throughout the document for internal consistency, to correct some errors in the '95 Code, to use defined terms consistently and eliminate redundancies, and to standardize the Code's structural premise and its application with respect to the use of certain conventions. Those conventions include italicized language; the use of the numbering system and the words "under" and "in" for purposes of designating debitable violations; and converting to "if"-based requirements, several provisions previously written as exceptions but numbered as debitable items.
     
  • Defined words and terms are in small capital letters throughout the Chapters and Annex 1 to highlight that they have a specific meaning within the context of the Code. Refer to the Preface, Information to Assist the Reader for a discussion of this feature.
     
  • Section numbers and definition numbers listed refer to the 1995 Code unless otherwise noted. Renumbering occurred in the 1997 edition, based on the changes made.

 


Chapter 1:

(11)(b) deleted "formed roast beef"

(12) deleted; §6-501.115 is the only place in the Food Code where the term is used and the terminology is generally understood and does not have a meaning unique to the Code

(19) 40 CFR Part 141 more appropriately stated as 40 CFR 141

(25)(a) corrected "water activity" to "warewashing"

(26) revised "Fish" in context of Seafood Final Rule; establishes consistency with the Seafood HACCP Regulation, 21 CFR 123.3(d); the term "mollusks" includes abalone, sea snails, and land snails (e.g., escargot and other terrestrial gastropods, such as the giant African land snail Achatina fulica); the addition of examples of aquatic life and the mention of mollusks are intended to make clear which species are covered by the term "fish"; water-dwelling reptiles and amphibians other than alligators, turtles, and frogs have not been specifically listed because they are not significant food sources in the United States; aquatic plants are excluded, consistent with the traditional treatment of these products by FDA; aquatic snakes are also excluded, consistent with their being considered game animals by FDA

(31)(b)(I) "permitted" is a defined term and is now in small caps

(33) Game animal definition revised to coincide with USDA definitions and to be consistent with ¶¶3-201.17(A) and 3-401.11(A)

(41) corrected "require" to "requires"

(60) (a)(iii) "Potentially hazardous food" definition revised ("raw shell eggs") to recognize in-shell pasteurization process;

(b) last phrase now describes garlic and oil mixtures that are not acidified or modified to render the mixture not potentially hazardous

(c) (v) The term "variance" was deleted since a variance from Code requirements is unnecessary where there is evidence that a food is not potentially hazardous as defined. Reworded to discuss multiple barriers that in combination inhibit growth; change recognizes that although a food has an elevated pH or aw, it may not be potentially hazardous as determined by lab evidence and classifying it as a food that is not potentially hazardous does not entail a variance

(c) (vi) added to capture the fact that food that is not potentially hazardous does not mean the food is free of pathogens

(61) "Poultry" definition revised for consistency internally and with USDA definition.

(62) "Premises" (b) The word "organization" was replaced with the word "operation" because the former seemed inappropriate for referring to the broad types of facilities that are listed as examples

"USDA" Definition added


Chapter 2:

2-102.11(C) amended (CFP 96-02-01)

2-102.11(M) amended to read "contribute to the transmission of ..."

2-103.11(H) (CFP 96-01-07) added term "ready-to-eat" for clarification of intent

2-201.11(D) (CFP 96-01-21) addressed "U.S." and its territories, separately and included reference to the CDC document used as the basis for Annex 7 guidance regarding travel out of the country. Deleted "illness" and "infection" after "hepatitis A virus" because the organism, not the illness is being discussed; subparagraph (D)(1)(c) changed "carrier" to "shedder"; language in D(4) and Form 1 made consistent

2-201.12(B) references (D) and in (B)(2) added Shigella spp. or E. coli O157:H7 to the end of the sentence so that no known asymptomatic shedders may work unrestricted in a food establishment (CFP 96-03-19)

2-201.13 (A)(2)(b) deleted (CFP 96-03-19) (A)(1) and (2) merged into (A) so that reinstatement of a person excluded due to a diagnosis involves the same medical clearance regardless of whether or not the person works in a facility serving a highly susceptible population

2-201.13 (B) and (C) added Crohn's disease as possible reason for symptom of foodborne illness that actually results from a noninfectious condition

2-201.13 (B)(2) added Shigella spp., or E. coli O157:H7 to the end of the sentence to be consistent with change to 2-201.12(B)(2) - i.e., for reinstatement from restriction of an asymptomatic shedder, the stools must be free of whichever is the infectious agent of concern

2-201.13 (C) and (D) revised to set the same standard for reinstatement for exclusion due to diagnosis, jaundice, and symptom plus a high-risk condition

2-201.15 "hepatitis A virus infection" "hepatitis A virus"

2-301.13 deleted but reserved (FDA response regarding CFP 96-03-08)

2-301.14 (F) moved to the opening statement; (C) cross references 2-403.11(B) and specifically mentions handling of aquatic animals (CFP 96-01-27)

2-301.16 (A) revised in accordance with OTC Drug and Food Additive requirements to provide specific information regarding hand sanitizers

2-304.11 changed (CFP 96-01-41/42)

2-403.11 (B) changed (CFP 96-01-27)


Chapter 3:

Note: Adjustments were made throughout Chapter 3 to accommodate the allowance for storage of potentially hazardous food at 45°F under certain conditions.

3-201.14 changed (CFP 96-03-37) (see also 8-201.13)

3-201.17 (A) recognizes USDA's Inspection Programs for Exotic Animals and for Rabbits; (B) prohibits use of a game animal that is on the list of endangered species for human food

3-202.11 used "such as" to list examples of foods that are not required to be 41°F upon receipt; changed to reflect existing temperatures in PMO for milk (45°F), NSSP Manual for molluscan shellfish (45°F ambient for shellstock and 45°F internal food temperature for shucked shellfish), and shell eggs; (C) changed to reflect addition of 3-401.16; added a ¶(D) to address maintaining frozen food frozen during shipment and upon receipt

3-202.12 added a reference to USDA 9 CFR as it applies to citric acid in cured pork

3-202.14/.15 combined these two provisions since they require pasteurization of certain foods; changed tagline

3-202.18 & .19 restructured and added language to be consistent with recently published 21 CFR 1240.60, Molluscan Shellfish

3-203.12 added new language requiring that tags be kept on the original shellstock container, unless the shellstock are removed and identified as provided in 2-203.12(B). Makes the shellstock tagging requirements consistent with the intent of the NSSP Manual, Part II, which requires that shellstock tags bear a statement that the tag will be attached to the container until empty

3-301.11 changed (FDA response to CFP 96-03-16)

3-302.11 (A)(4) "covered containers, or wrappings"; subparagraph (B)(5) added to recognize that shellstock are not required to be covered

3-302.13 "raw shell eggs" added to acknowledge the use of in-shell pasteurization process; "noncommercial mayonnaise" "mayonnaise" to eliminate ambiguity; ¶ (B) moved to new 3-801.11

3-304 Subpart name changed to reflect insertion of a new 3-304.13

3-304.11(B) cross reference changed to the appropriately debited provision

3-304.13 added a new .13 to insert linens and napkins use limitation portion of 4-101.16

3-304.14 combined two sections on use limitations on gloves into this one section;

§3-304.14 addressed the use limitations for single-use gloves, but §4-502.15 addressed the use limitations for slash-resistant gloves; §4-502.15 deleted and the wording moved to ¶¶3-304.14(B) and (C); ¶(D) limitations regarding the use of cloth gloves moved here from ¶4-101.16 (C)

3-304.16(B) cross reference made specific to ¶4-603.17(B)

3-306.15 relocated to §3-801.11

Part 3-3 created a new Subpart 3-307 to provide an "other" category to capture sources of contamination not specifically delineated in 3-301 through 306

3-401.11 restructured and reworded; merged cooking and oven parameter charts into text; made changes to specifically address time/temperature for ratites; clarified the cooking temperature requirement for game animals commercially raised for food and identified these animals as needing the same microbial inactivation as other similar meats and fish; since an in-shell pasteurization process exists, specific reference to raw shell eggs emphasizes the applicability of the requirement to raw eggs only

3-401.11(A)(2) changed to "or the temperature ... that corresponds to the holding time"

3-401.11(A)(3) vs ¶3-401.11(C) Combined the two sections; relocated the beef cooking temperatures from ¶(C) to Subparagraph (A)(3) to provide better continuity for the raw animal food cooking temperature requirements and located all cooking parameters within Subparagraph (A)(1)

3-401.11(B)(2)(b) "that shows" "showing"

3-401.11(C)(1) changed (CFP 96-01-11)

3-401.12 changed and corrected "cooking" to "holding" time (CFP 96-03-24)

3-401.13 chart (now merged into 3-401.11) modified for clarity to properly convey the research report upon which it is based (ABC Research May 2, 1979 "Fate of Salmonella inoculated into beef for cooking").

  • "Less than or equal to 4.5 kg (10 lbs)" changed to "Less than 4.5 kg (10 lbs)"
  • "Greater than 4.5 kg (10 lbs)" reads "4.5 kg (10 lbs) or more"
  • The temperature specified for convection oven cooking of roasts weighing 4.5 kg or more changed from 163° to 121°
  • Conveys that the temperatures specified for Still Dry and Convection ovens mean that a roast may be cooked safely at a temperature as low as those specified (i.e., a minimum)
  • The temperatures specified for High Humidity cooking mean the temperature specified or a lesser temperature that will deliver the cook/hold time and temperature
  • Corrected the oven temperature requirement for >10 lbs in a convection oven

3-401.15 (3-401.12 in the '97 Code) addressed microwave industry's information/concerns by specifying 165F throughout the food

3-401.13 a new section ("Plant Foods") added to address the proper cooking of vegetables & fruits for hot holding; Part 3-4 previously addressed cooking only as it applied to raw animal-derived foods

3-402.11 & .12 changed (CFP 96-01-11)

3-402.11 updated to reflect Seafood HACCP rule which recognizes certain species of tuna do not need to be frozen to prevent parasitic infection if ingested in raw state

3-403.11 (B) changed to read: "... food reheated in a microwave oven for hot holding ..."

3-403.11 changed ¶(D) to only require the rapid (2 Hour) reheat between the required refrigeration temperature and 165°F

3-403.12 §3-403.10

3-501.12 - .14 updated to recognize existing equipment per revised ¶3-501.16 (C)

(CFP 96-03-21)

3-501.14(D) added to specify that shell eggs placed upon receipt in a refrigerated unit that is capable of maintaining food at the required temperature constitutes satisfactory compliance

3-501.16 (C)& .18 (A) revised cold holding provisions relating to existing equipment but did not include a consume-by date for the food which was part of the proposed language (CFP 96-03-21 and AFDO); ¶(A) cross references the allowance in ¶3-403.11(E) for reheating roasts using the roast cooking chart

3-501.17 and .18 revised and restructured to: clarify when date marking is to be done; address the use of foods that require date marking and that are frozen at some point in between preparation and the number of days at which they must be consumed; indicate the number of days allowed at 41°F and 45°F; and specify the situations under which marked or unmarked food is to be discarded

3-501.19 (A) revised for clarity; (B) revised to read "... cooked and served, served if ready-to-eat, or discarded." Changed to add clarification to the methods of marking and disposition of the food at the end of 4 hours

3-502.11 modified to include adding components (in addition to "food additives") for either food preservation or as a means of making a food not potentially hazardous; clarified that variance applies to ROP foods where a C. bot. barrier in addition to refrigeration exists

3-502.12 (A)(2)(c) revised to recognize alternatives for curing meat and poultry in USDA CFR

3-601.11 updated to encompass all standards of identity

3-602.11 expanded for clarity and to provide more detailed information regarding labeling requirements

3-602.11 and 3-602.12 rewritten so that certain findings will not rationally be judged as violating either or both of these sections

3-603.11 Inserted page explaining current status of consumer advisory

3-801.11 created new part, subpart, section to combine food restrictions for highly susceptible populations in one provision; added requirement for the use of pasteurized (or commercially sterile, shelf-stable) apple cider, apple juice, and other beverages containing apple juice; requires substituting pasteurized eggs for "raw shell eggs" to recognize in-shell pasteurization process; ¶(D) refers to "raw-marinated" fish (CFP 96-01-11)


Chapter 4:

Note: Adjustments were made in Chapter 4 to accommodate the allowance for storage of potentially hazardous food at 45°F under certain conditions.

4-101.13 "lead" included in the tagline; 1.1 was not addressed in the 1995 Code (chart revised)

4-101.14 added a ¶(B) regarding brewing alcoholic beverages to address the level of copper that is toxic to yeast versus the level of copper that is toxic to humans

4-101.15 redrafted the provision in conformance with Agency policy

4-101.16 (A) and (B) moved to new 3-304.13; (C) moved to ¶3-304.14(D)

4-101.17 changed tagline and provision to address pewter alloys (CFP 96-01-46) Lead is excluded from modern pewter. ASTM B 560-79 standard is the basis for the cited lead level

4.101.18 added the word "lead" in the tagline

Subpart 4-101 added 4-101.110 to address the use of perfluorocarbon resin which is used to provide a "nonstick finish" or "nonstick coating"; it is a noncorrosive plastic material that has been approved for food-contact surfaces since 1960; it has been determined that even the flakes cause no health hazard if ingested; the maintenance of the surfaces is covered under ¶4-502.11(A)

4-202.11(E)(3) changed to keep the Code consistent with recent NSF Joint Committee deliberations and decisions about what constitutes easy disassembly, i.e., NSF definition of "simple tools" = handheld tools commonly available to maintenance and cleaning personnel such as screwdrivers, pliers, open-end wrenches, and Allen wrenches.

4-203.11 & .12 changed accuracy for the use range (CFP 96-01-47)

4-203.13 addressed the accuracy of the warewashing machine flow pressure measuring device, i.e., plus or minus 14 kilopascals (2 psi). Flow pressure is a very important factor in sanitization efficacy as recognized in NSF Standard #3, Section 5.1.12.2.

4-204.112 expanded ¶(E) to address temperature measuring devices (TMDs) for warewashers, the use range, and to be consistent with NSF Standard #3, 5.1.7.2.

4-204.117 added requirement for low sanitizer alarm (portion of CFP 96-03-33)

4-204.118

 

  • added a requirement for a pressure measuring device such as a gauge or electronic transducer
     
  • eliminated the requirement for a 1/4 inch IPS valve except where the pressure measuring device is installed on the line pressure side of the solenoid valve (see NSF #3, 5.1.12.2)

4-205.10 added new subpart and section to address equipment that is certified or classified by ANSI-accredited certifying organizations (CFP 92-01-02/94-01-03)

4-301.12 (D)(2)(d) added to address hot water sanitization in a 2-compartment sink

4-401.11 deleted one inappropriate cross reference

4-501.110 (A)(1) use of "single tank" redundant and deleted; see NSF #3; order rearranged to keep similar types of machines together

4-501.112 restructured and clarified to alleviate misinterpretation regarding the intent of the maximum temperature component (90°C/194°F) of this provision; it does not apply to wand-type hand-held high pressure (high temperature) now widely used for cleaning/sanitizing equipment such as meat saws, etc. In (A), "single tank" was redundant and was deleted; see NSF Standard #3, Table one

4-501.113 changed to "immediately downstream or" to be consistent with §4-204.117

4-501.114 (C)(3) changed to a maximum of 500 ppm hardness or not to exceed the hardness level specified by the manufacturer

4-502.11 (A) changed to address repair of water and ambient TMDs (Food TMDs are included under the definition of "utensil") and Pressure Measuring Devices

4-502.13 included interpretation in the Code regarding dispensing tube on bulk milk machines; cut on diagonal leaving no longer than one inch protruding from chilled dispensing head

4-502.15 deleted entire section; combined with §3-304.14

4-602.11 expanded to address cleaning of equipment such as reach-in refrigerators, surfaces contacting food that is not potentially hazardous, and food storage equipment used for food that is not potentially hazardous, e.g., iced tea and soft drink dispensers and coffee bean grinders

4-701.11 changed 4-701.10 and added an asterisk to §4-702.11

4-703.11 (C) recognized 7 seconds contact time for chlorine solution of 50 mg/L based on NSF study (CFP Executive Board discussion re FDA response to CFP 96-03-33)


Chapter 5:

5-102.12(A) reworded for clarity

5-202.14 corrected "Engineers" to "Engineering"

5-203.12 revised for clarity and to accommodate local plumbing provisions regarding the substitution of urinals for toilets

5-203.15 deleted but reserved (CFP 96-03-01)

5-302.16 changed (CFP 96-03-41)

5-303.12 "equipment" "cover"

5-402.11 5-402.10 and "sized" changed to "designed"

5-501.13 and .15 "equipment" "waste handling unit"

5-501.18 "equipment" "implement" and "waste handling unit"

5-501.19 "equipment" "waste handling unit" and "public health hazard or nuisance"

5-501.110 "equipment" "waste handling unit"

5-501.113/ .114/ .116 "equipment" "waste handling unit"


Chapter 6:

6-201.11 added cross reference to §6-201.14

6-201.14(A) added to the end of the sentence: "... or other areas where the floor is subject to moisture, flushing, or spray cleaning methods"; ¶(B), specified what "other areas" means in context of ¶(A)

6-201.18 cross reference replaced with "(areas) subject to moisture"

6-202.12 "food preparation surfaces" "food-contact surfaces"

6-202.13 (A)&(B) Electrocution Devices rewritten to clarify that the electronic device in ¶(A) is the same type as the electronic device in ¶(B)

6-202.15 rewritten because it could be interpreted in different ways; rewritten and restructured for clarity and to address in the context of food courts in malls, cafeterias in office buildings, and airport food establishments

6-301.11(B) deleted (CFP 96-03-08)

6-301.11 & .12 changed for consistency "have available" versus "be provided with"

6-303.11 ¶(B) addressed lighting in a reach-in refrigerator, under-counter refrigerators and consumer self-service areas, and clarified the point at which the measurement of intensity is appropriate for determining compliance

6-405.10 "equipment" "waste handling units" and tagline changed

6-5 subpart name changed

6-501.14 "public health hazard or nuisance"

6-501.111(B)(3) changed "extermination" to "other means of pest control" and revised to eliminate repetition of definition of "premises" in 1995 edition in Subparagraphs (A)(1) and (2)

6-501.113 "equipment" "tools"/ "items" and ¶(B) reworded


Chapter 7:

7-201.11 and 7-301.11 "may not" "can not"

7-207.12 day care centers want them on top shelf so children cannot reach them. ¶(B) amended to reflect APHA Guidelines that state "inaccessible to children" and the word "employees'" deleted since medicines may also belong to children in a day care setting

7-206.11 revised to accurately reference the CFR

7-209.11 added related cross references


Chapter 8:

8-101.10 (B)(4) added cross reference to new ¶ 8-304.11(H) the effect of which is to require a documented agreement of the permit holder to upgrade or replace existing refrigeration equipment as specified under ¶ 3-501.16(C) within 5 years of Code adoption unless one of the reasons for upgrading or replacing the unit specified under ¶8-304.11(G) occurs first

8-102.10, 8-103.10, and 8-103.11 "public health hazard (or/and) nuisance"

8-201.13 (A)(2) deleted reference to Subparagraph 3-201.14(A)(2)(b) since variance provision regarding recreationally caught fish is replaced with approval by the Regulatory Authority (CFP 96-03-37)

8-304.11 (G) "public health Hazard""public health Hazard or nuisance"; Added a new (H) which makes the permit holder responsible for upgrading or replacing existing refrigeration equipment as specified under ¶3-501.16(C) within 5 years of Code adoption unless one of the reasons for upgrading or replacing the unit specified under ¶8-304.11(G) occurs first; ¶¶(H), (I), & (J) relettered to (I), (J), and (K)

8-401.10 changed the tag line from "Establishing" to "Establishing Inspection Interval"

Annex 1:

8-803.10 (A) broken into (1) - (4), updated in accordance with Seafood HACCP rules, 21 CFR 1240.60(d), and annotated to show this addition as the basis for Code provisions related to potential seizure of untagged, unlabeled, mistagged, or mislabeled molluscan shellfish

Annex 2:

Definition of Adulteration as amended in 1996 included (CFP 96-01-12)

References - updated and corrected as appropriate

Annex 3:

Changed title of Annex to include Administrative Guidance

Reasons updated to correlate to the changes in Code provisions

Annexes 4 & 5:

Minor changes; term "risk assessment" modified in several places

Annex 6:

Minor changes for clarification and to coincide with changes in Chapter 3 with respect to when reduced oxygen packaging requires a variance and alternatives in the CFR administered by USDA for curing meat and poultry products

Annex 7:

Forms and Guides updated to reflect changes in Chapter 2

Inspectional Guide updated to show changes in Code provision structure and titles

Summary Charts for cooking and reheating times and temperatures added

Matrix for mobile units added (CFP 94-01-01(A))

Final version of this Summary provided

Acronyms:

AFDO = Association of Food and Drug Officials
APHA = American Public Health Association
ASTM = American Society of Testing Materials
CDC = Centers for Disease Control and Prevention
CFP = Conference for Food Protection
CFR = Code of Federal Regulations
HACCP = Hazard Analysis Critical Control Point
NSF = NSF International
NSSP = National Shellfish Sanitation Program
OTC = Over the Counter
PMO = Pasteurized Milk Ordinance
ROP = Reduced Oxygen Packaging