Rhode Island Code of Regulations
Title 216 - Department of health
Chapter 50 - Environmental health
Subchapter 10 - Food Protection
Part 4 - Good Manufacturing Practices for Food (216-RICR-50-10-4)
Section 216-RICR-50-10-4.2 - DEFINITIONS

Universal Citation: 216 RI Code of Rules 50 10 4.2

Current through September 18, 2024

A. The following definitions shall apply in the interpretation and application of these Regulations:

1. "Administrative penalty" means a civil monetary fine that RIDOH may assess pursuant to statutory authority.

2. "Adulterated food" means the definition in R.I. Gen. Laws § 21-31-10 and as described below.

3. "Air temperature" means that steady temperature determined by allowing the probe of an accurate thermometer or other appropriate means of temperature measurement to equilibrate to the temperature of a representative area of the air environment in question.

4. "Approved laboratory" means a laboratory approved by the Director or certified by the EPA or certified by the primary enforcement authority in any state which has been granted primacy by EPA or certified (accredited) by a third-party organization acceptable to a primacy state.

5. "Approved source," when used in reference to a bottled water plant's product water or water used in the plant's operation, means the source of the water whether it be from a spring, artesian well, drilled well, public or community water system or any other source that has been inspected and the water sampled, analyzed and found to be of a safe and sanitary quality, per standards approved by the Director.

6. "Bottled water" means bottled water as defined in 21 C.F.R. § 129.3(b).

7. "Bottled water plant" means any place or establishment in which bottled water is prepared for sale.

8. "Bulk water" means water intended for potable uses, which is transported via tanker truck or an equivalent means from one area to another for the purposes of treatment, processing, packaging and/or human consumption, including bottling purposes.

9. "Carbonated non-alcoholic beverage" means a carbonated beverage of any flavor containing no alcohol and includes but is not limited to soda water, sparkling water made with added carbon dioxide, seltzer water, carbonated water and tonic water.

10. "Carbonated water" or "Sparkling water" means bottled water containing carbon dioxide.

11. "Center" means the Center for Food Protection of the Rhode Island Department of Health.

12. "C.F.R." means the Code of Federal Regulations.

13. "Critical violation" means any violation by a facility or any other occurrence or condition in a facility that has the potential to pose a threat to public health.

14. "Dedicated" means equipment used exclusively for the bottling, manufacturing for water and food.

15. "Denature" means to use a material to render an article unfit for human consumption.

16. "DEM" means the Rhode Island Department of Environmental Management.

17. "Director" means the Director of RIDOH.

18. "Embargo" means action taken pursuant to R.I. Gen. Laws § 21-31-6.

19. "EPA" means the U.S. Environmental Protection Agency.

20. "Equipment" means items used in the storage, preparation, display, or transportation of food such as stoves, ovens, hoods, slicers, grinders, mixers, scales, cutting blocks, tables, food shelving, reach-in refrigerators and freezers, sinks, ice makers, dishwashers, steam tables, utensils and similar items used in the operation of a food processing operation.

21. "Facility" means the premises or parts thereof, and delivery or other vehicles used for or in connection with the slaughtering, preparing, processing, manufacturing, packaging, repackaging, canning, bottling, keeping, exposing, storing, handling, distributing, transporting or holding of food. It does not include a food establishment as defined in the Rhode Island Food Code.

22. "Farm warehouse (meat products)" means a frozen storage area on a farm used to hold meat that has been slaughtered and packaged in a USDA facility.

23. "Fluoridated water" means bottled water containing fluoride. The label shall specify whether the fluoride is naturally occurring or added. Any water which meetings the definition of this subsection shall contain not less than 0.8 milligrams per liter fluoride ion and otherwise comply with the FDA quality standards in 21 C.F.R. Part 165.110(b)(4)(ii).

24. "FDA" means the U.S. Food and Drug Administration.

25. "Food" means articles used for food or drink for man or other animals; chewing gum; articles used for components of any such article; includes raw materials and ingredients; as defined in the federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321(f). Food includes dietary supplements as defined in the federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321(ff).

26. "Food-contact surfaces" means those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. Food-contact surfaces includes utensils and food-contact surfaces of equipment.

27. "Freezing" means the removal of latent heat from the product, so that it enters a solid state.

28. "Frozen" means the temperature of the product (except frozen desserts) has reached 0°F (-18°C) or lower at the thermal center, after thermal stabilization.

29. "Frozen dessert mix" means any unfrozen mixture to be used in the manufacture of frozen desserts or milk shakes.

30. "Frozen food" means articles in package form used for food or drink for man or other animals, which have been preserved by freezing.

31. "FSIS" means the Food Safety and Inspection Service of the U.S. Department of Agriculture.

32. "Grade A" means the standard of quality which may be attached to all those products which meet the requirements of and have been processed in accordance with the requirements of the RIDOH's administrative regulations based on the Grade "A" Pasteurized Milk Ordinance (PMO).

33. "Hermetically sealed container" means a container designed and intended to be secure against the entry of microorganisms and to maintain the commercial sterility of its contents after processing.

34. "Imminent danger to the public health" means any occurrence or condition which has the potential to pose a serious threat to public health and shall include, but not be limited to:
a. A loss of water supply that may result in adulteration of food;

b. The use of an unapproved source of water within the facility;

c. A failed sewer system or a sewage backup into the facility;

d. A power outage that may result in adulteration of food;

e. Information that indicates that food may have been intentionally adulterated;

f. The facility has been subject to one or more of the following: flood, fire, chemical exposure, natural disaster and/or catastrophic event;

g. An employee is found to be infected with a communicable disease;

h. A food-borne illness outbreak that appears to be associated with the facility;

i. Severe unsanitary conditions that threaten to contaminate the facility, a part of the facility, or a particular product;

j. Failure to comply with an order to correct a critical deficiency immediately;

k. Failure to submit an approved correction plan for a critical deficiency in timely manner;

l. Failure to comply with an approved correction plan for a critical deficiency in a timely manner; or

m. Failure to carry out a product recall.

n. The failure to include other violations, occurrence or conditions in Imminent Danger to the Public Health shall not be construed as a determination that such other violations, occurrences or conditions are not or may not be considered an imminent danger to the public health.

35. "Inedible" means adulterated or not intended for use as human food.

36. "Inspector" means an agent of the Rhode Island Department of Health, as defined in R.I. Gen. Laws § 21-31-21.

37. "Juice" means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one of more fruits or vegetables, or any concentrates of such liquid or puree.

38. "Label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of these Regulations that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper, as defined in the federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321(k).

39. "Labeling" means all labels and other written, printed, or graphic matter:
a. upon any article or any of its containers or wrappers, or

b. accompanying such article, as defined in the federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321(m).

40. "Landing" means that point in time when seafood has been brought on-shore after harvesting.

41. "Law" means any applicable federal, state or local statute, ordinances and regulations.

42. "License" means any license or permit issued by RIDOH pursuant to these regulations and applicable statutes.

43. "Licensee" means any person who holds a license or permit issued by RIDOH pursuant to these regulations and applicable statutes.

44. "Livestock" means any animal raised commercially or privately, excluding poultry, which can or may be used in and for the preparation of meat or meat food products. In these regulations, livestock includes so-called non-amenable animals raised for sale as food, including but not limited to buffalo, rabbits, frogs and turtles.

45. "Major food allergen" means a major food allergen as defined by 21 U.S.C. § 321(qq).

46. "Meat" except as used in § 4.6 of this Part, means the edible portion of livestock or wild-caught animals after slaughter.

47. "Meat food product" means any article used as human food which is made wholly or in part from any meat or other portion of the carcass of any livestock, except those exempted from definition as a meat food product pursuant to 9 C.F.R. Part 317.

48. "Misbranded food" means the definition of R.I. Gen. Laws § 21-31-11.

49. "Noncompliance," "Failure to comply," and "Violation" each mean any act or failure to act that constitutes or results in one or more of the following:
a. Engaging in any operation subject to these regulations or applicable statute, without a license, permit, or approval whenever engaging in such an operation requires a license, permit or approval;

b. Engaging in any activity prohibited by, or not in compliance with these regulations or other applicable statute or regulation, or prohibited by or not in compliance with any order, license, permit, approval, certification, guideline, policy or protocol issued by RIDOH pursuant to these regulations or applicable statute.

c. Failing to do, or failing to do in a timely manner, anything required by these regulations or other applicable statute or regulation, or required by any order, license, permit, approval, certification, guideline, policy or protocol issued by RIDOH pursuant to these regulations or applicable stature.

50. "Pasteurization plant" means a facility for the pasteurization of milk.

51. "Person" means any individual, partnership, corporation, association or other legal entity.

52. "Person in charge" means the individual present in the facility who has actual or apparent authority to supervise the activities of the facility and the employees at the time of the inspection.

53. "Pest" refers to any objectionable animals or insects including, but not limited to, birds, rodents, flies and larvae.

54. "Potentially hazardous food" or "PHF", has the same meaning as "Time Temperature Control for Safety Food" or "TCS".

55. "Poultry" means any bird, whether live or dead, intended for use as food.

56. ''Poultry food product" means any product capable of use as human food which is made wholly or in part from any poultry carcass or part thereof, except those exempted from definition as a poultry product pursuant to 9 C.F.R. § 381.15.

57. "Public water system" means a system for the provision to the public of water for human consumption, as defined by 42 U.S.C. § 300(f), the Safe Drinking Water Act, in compliance with R.I. Gen. Laws or comparable standards of the state or foreign country where the public water system is located.

58. "Reduced oxygen packaging" or "ROP" means the removal or partial removal of oxygen from a package with or without replacing it with a gas mixture, to control food spoilage. ROP includes controlled atmospheric packaging (CAP), modified atmospheric packaging (MAP), straight vacuum packaging (VP), sous vide and cook-chill.

59. "Refrigeration" means mechanical lowering of the temperature of food to, at a maximum, 41°F (5°C), or to a temperature required by other applicable law, regulation or ordinance.

60. "Regulatory agency" means the Rhode Island Department of Health, Center for Food Protection.

61. "Remodel" means to make a material change to the facility.

62. "Retail" means sale to the ultimate consumer.

63. "Retail seafood dealer" means a person who sells raw, fresh or frozen seafood directly to the consumer.

64. "RIDOH" means the Rhode Island Department of Health.

65. "R.I. Gen. Laws" means the General Laws of Rhode Island, as amended.

66. "Safe and suitable" means that the ingredient performs an appropriate function in the food in which it is used and is used at a level no higher than necessary to achieve its intended purpose in that food.

67. "Seafood" means all fish and/or fishery products.

68. "Sell" means to sell, offer or expose for sale, barter, trade, deliver, give away, possess with intent to sell, or dispose of in any other commercial manner.

69. "Shelf life" means a period after the date of packaging during which a food product has no significant risk of spoilage, loss of nutritional value, or loss of palpability, given compliance with recommended conditions of storage and handling as disclosed on the label of such product.

70. "These regulations" shall mean all parts of the rules and regulations for the Rhode Island Department of Health Good Manufacturing Practices for Food (216-RICR- 50-10-04).

71. "Time temperature control for safety food" "TCS" means any food or food ingredient, natural or synthetic, in a form capable of supporting a) the rapid and progressive growth of infectious or toxigenic microorganisms or b) the slower growth of Clostridium botulinum.

72. "USDA" means the United States Department of Agriculture.

73. "Water Source" means any ground or surface water body and the site from which water is withdrawn.

74. "Wholesale" means sale to other than the ultimate consumer.

75. "Wholesale seafood dealer" means a person who in a facility does any or all of the following: handling, storing, preparing, heading, eviscerating, shucking, freezing, manufacturing, preserving, packing, labeling or shipping raw fish and/or shellfish, whether frozen or unfrozen, for sale at wholesale.

76. "Wild game" means an animal that is used for food, that is not domesticated and that is harvested in the wild, including but not limited to wild deer, elk, moose, rabbits, squirrels and raccoons, and wild birds such as ducks, pheasants, quail and turkeys.

4.2.1 ADULTERATED FOOD

A. The criteria and definitions in these Regulations shall apply in determining whether a food is adulterated:
1. Within the meaning of R.I. Gen. Laws § 21-31-10(1)(iii) in that the food has been manufactured under such conditions that it is unfit for food; or

2. Within the meaning of R.I. Gen. Laws § 21-31-10(1)(iv) in that the food 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.

B. The criteria and definitions in these Regulations also apply in determining whether a food is in violation of §361 of the Public Health Service Act (42 U.S.C. § 264).

C. Food covered by specific current good manufacturing practice regulations is also subject to the requirements of these regulations.

D. For the purposes of these Regulations, a food shall be deemed to be adulterated:
1. Poisonous, Insanitary or Deleterious Ingredients
a. If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but if the substance is not an added substance such food shall not be considered adulterated under §4.2.1(D)(1)(a) of this Part if the quantity of such substance in such food does not ordinarily render it injurious to health; or

b. 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 or a color additive) that is unsafe within the meaning of §408(a) of the Federal Food, Drug and Cosmetic Act; or

c. If it bears or contains a pesticide chemical residue that is unsafe within the meaning of §408(a) of the Federal Food, Drug and Cosmetic Act; or

d. If it is or if it bears or contains:
(1) any food additive that is unsafe within the meaning of §409 of the Federal Food, Drug and Cosmetic Act; or

(2) a new animal drug (or conversion product thereof) that is unsafe within the meaning of §512 of the Federal Food, Drug and Cosmetic Act; or

e. If it consists in whole or in part of any filthy, putrid or decomposed substance, or it is otherwise unfit for food; or

f. If it has been prepared, packaged or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health; or

g. 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

h. 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

i. If it has been intentionally subjected to radiation, unless the use of radiation was in conformity with a regulation or exemption in effect pursuant to §409 of the Federal Food, Drug and Cosmetic Act.

2. Absence, Substitution or Addition of Constituents
a. If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or

b. If any substance has been substituted wholly or in part therefore; or

c. If damage or inferiority has been concealed in any manner; or

d. If any substance has been added thereto or mixed or packed therewith to increase its bulk or weight, or reduce its quality or strength or make it appear better or of greater value than it is.

3. Color Additives
a. If it is, or it bears or contains, a color additive which is unsafe within the meaning of §721(a) of the Federal Food, Drug and Cosmetic Act.

4. Confectionary Containing Alcohol or Nonnutritive Substance. If it is confectionary, and:
a. Has partially or completely imbedded therein any nonnutritive object except that this requirement shall not apply in the case of any nonnutritive object where the FDA has determined that such object is of practical functional value to the confectionary product and would not render the product injurious or hazardous to health;

b. Bears or contains any alcohol other than alcohol not more than one-half of one per centum (0.5%) by volume derived solely from the use of flavoring extracts, except that this is requirement shall not apply to confectionary which is introduced or delivered for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionary is permitted under the laws of the state in which such confectionary is intended to be offered for sale; or

c. Bears or contains any nonnutritive substance, except that this requirement shall not apply to a safe nonnutritive substance which is in or on confectionery due to 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 these Regulations.

5. Oleomargarine Containing Filthy, Putrid, etc., Matter.
a. 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.

6. Dietary Supplement or Ingredient: Safety. If it is a dietary supplement or contains a dietary ingredient that:
a. Presents a significant or unreasonable risk of illness or injury under:
(1) conditions or use recommended or suggested in labeling, or

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

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; or

c. The FDA declares that it poses an imminent hazard to public health or safety; or

d. Is or contains a dietary ingredient that renders it adulterated under §4.2.1(D) of this Part under the conditions of use recommended or suggested in the labeling of such dietary supplement.

7. Dietary Supplement: Manufacturing Practices.
a. If it is a dietary supplement and it has been prepared, packed or held under conditions that do not meet current good manufacturing practices standards established by these Regulations or regulations promulgated by the FDA, including, when necessary, expiration date labeling.

8. Unsanitary Transport
a. If it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver or any other person engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under §416 of the Federal, Food, Drug and Cosmetic Act.

Disclaimer: These regulations may not be the most recent version. Rhode Island may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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