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

Current through June 14, 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.