Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 500.000 - Good Manufacturing Practices For Food › Section 500.003 - Definitions

Current through Register 1525, July 5, 2024
For the purposes of
				105 CMR 500.000, the
				following terms shall have the following meanings.
Administrative Penalty
means a civil
				monetary fine that the Department may assess pursuant to statutory
				authority.
Adulterated Food
means the definition
				in M.G.L. c. 94, § 186.
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.
Allergen
:
see
Major Food Allergen
.
Approved Laboratory
means a laboratory
				approved by the Department as a milk laboratory as provided in
				105
				CMR 500.062(C).
Approved Water-testing Laboratory
means a laboratory certified by the Massachusetts Department of Environmental
				Protection (DEP) or certified by the U.S. Environmental Protection Agency (EPA)
				or approved by another state or jurisdiction to perform drinking water analyses
				in accordance with standard water quality testing methods.
Bait
means any food, used for the
				attraction and harvest of seafood, which may or may not be of sufficient
				sanitary quality for human consumption.
Board of Health
means the appropriate
				and legally designated health authority of the city, town, or other legally
				constituted governmental unit within Massachusetts having the usual powers and
				duties of the board of health or health department of a city or town.
Bottled Water
means
Bottled Drinking Water
as defined in
				21 CFR §
									129.3(b).
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 purpose of treatment, processing, packaging, and/or
				human consumption.
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.
CFR
means the Code of Federal
				Regulations.
Commissioner
means, except where
				otherwise specified, the Commissioner of the Department of Public
				Health.
Critical Violation
or
Critical Deficiency
means any violation of
				105 CMR 500.000 by a
				facility or any other occurrence or condition in a facility that has the
				potential to pose a threat to public health and shall include but not be
				limited to the following:
(1) Use or presence of food or a food ingredient from an
				unapproved or unknown source;
(2) Use or presence of food or a food ingredient that is or may
				be adulterated, misbranded, contaminated, or otherwise unfit for human
				consumption;
(3) Any activity that misrepresents the origin, source, date,
				and/or disposition of any food product intended for human consumption;
(4) Potentially hazardous food that is held at a temperature
				which is
(a) Greater than 45° F (7.2° C) in the case of milk or
				milk products or raw molluscan shellfish;
(b) Greater than 41° F (5° C) in the case of cold food
				other than milk or milk products; or
(c) Less than 140° F (60° C) in the case of hot
				food;
(5) Inability to maintain appropriate product
				temperature;
(6) A person infected with a communicable disease that can be
				transmitted by food is working as a food handler;
(7) A worker in the facility is not practicing strict standards
				of cleanliness and personal hygiene (as an example only, bare-hand contact with
				ready-to-eat food), which may result in the potential transmission of illness
				through food;
(8) Equipment, utensils, or food contact surfaces are not
				cleaned and sanitized effectively and may contaminate food during preparation,
				processing, storage, transportation, or service;
(9) Sewage or liquid waste is not disposed of in an approved
				and sanitary manner, or the sewage or liquid waste contaminates or may
				contaminate any food, areas used to store or prepare food, or any areas
				frequented by customers or employees;
(10) Toilets and facilities for washing hands are not provided,
				or are not properly installed, designed, equipped, accessible, or
				convenient;
(11) The supply of water is not from an approved source or is
				not under pressure and the facility does not have approval from the Department
				to use single service articles and/or bottled water from an approved source on
				a temporary basis;
(12) A defect exists in the system supplying potable water that
				may result in the contamination of the water;
(13) There is evidence of the presence of insects, rodents,
				vermin, or other animals (except service animals) on the premises;
(14) Toxic items are improperly labeled, stored, or
				used;
(15) There is a power outage that poses an imminent danger to
				the public health;
(16) Drug residues have been found in a second sample of raw
				milk or a raw milk product and the manufacturer has failed to destroy the
				violative products as required by
				105 CMR
				500.082(A)(1)(c); or
(17) The facility does not have a Hazard Analysis Critical
				Control Point (HACCP) plan when such a plan is required by section
				105
				CMR 500.016(A)(2),
				500.020(F) or
				(G), or
				500.021(A).
The failure to include other violations, occurrences, or
				conditions in 105 CMR 500.003:
Critical Violation
or
Critical Deficiency
shall not be construed as a
				determination that such other violations, occurrences, or conditions are not,
				or may not be, considered a critical violation.
Custom Processing
means the preparing
				or processing of meat or poultry, the product of which is not to be sold or
				given away and is only for the personal use of the owner of the animal, members
				of his or her household, and his or her nonpaying guests or employees.
Custom Slaughter
means the slaughter
				of livestock or poultry which is not to be sold or given away and is only for
				the personal use of the owner of the animal, members of his or her household,
				and his or her nonpaying guests or employees.
Denature
means to use a material to
				render an article unfit for human consumption.
DEP
means the Massachusetts Department
				of Environmental Protection.
Department
means the Massachusetts
				Department of Public Health.
Dietary Supplement
means a product
				defined in
				21 U.S.C. §
									321(ff).
Division of Marine Fisheries
means the
				Division of Marine Fisheries of the Massachusetts Department of Fish and
				Game.
Edible
means intended for use as human
				food.
Embargo
means action taken pursuant to
				M.G.L. c. 94, § 189A and
				105 CMR 500.209.
Employee
means the licensee or permit
				holder, individual having supervisory or management duties, person on the
				payroll, family member, volunteer, person performing work under contractual
				agreement, or any other person working in the facility, excluding persons whose
				tasks do not involve the operation of the facility, such as an outside plumbing
				contractor.
EPA
means the U.S. Environmental
				Protection Agency.
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.
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
				105 CMR 590.000:
State Sanitary Code Chapter X - Minimum Sanitation Standards for Food
				Establishments
.
FDA
means the U.S. Food and Drug
				Administration.
Fish
means fresh or saltwater finfish,
				crustaceans, other forms of aquatic animal life (including, but not limited to,
				alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin, and
				the roe of such animals) other than birds or mammals, and all molluscan and
				non-molluscan shellfish, when such animal is intended for human
				consumption.
Fishery Product
means any human food
				product in which fish is a characterizing ingredient.
Food
means all articles whether
				simple, mixed, or compound, used for food or drink, confectionery or condiment,
				by man or animal.
Food
includes dietary supplements as
				defined in the federal Food, Drug and Cosmetic Act,
				21 U.S.C. §
									321(ff).
Freezing
means the removal of latent
				heat from the product, so that it enters a solid state.
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.
Frozen Dessert
includes but is not
				limited to ice cream, French ice cream, low fat ice cream, nonfat ice cream,
				frozen custard, gelato, ice milk, sherbet, sorbet, frozen yogurt, water ice,
				quiescently frozen confection, quiescently frozen dairy confection, frozen
				dietary dairy dessert, any soy-based frozen dessert, any rice-based frozen
				dessert, and any other similarly constituted product marketed as a frozen
				dessert.
Frozen Dessert
includes products made from
				the milk of cows, sheep, goats, and other dairy animals.
Frozen Dessert Mix
means any unfrozen
				mixture to be used in the manufacture of frozen desserts or milk shakes.
Frozen Food
means articles in package
				form used for food or drink for man or other animals, which have been preserved
				by freezing.
FSIS
means the Food Safety and
				Inspection Service of the U.S. Department of Agriculture.
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 Department's
				administrative guidelines based on the Grade "A" Pasteurized Milk Ordinance
				(PMO).
Harvest
means to catch, dig, take or
				attempt to catch, dig or take any fish, shellfish or bait.
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.
Imminent Danger to the Public Health
means any violation of
				105 CMR 500.000, or any
				other occurrence or condition, that has the potential to pose a serious threat
				to public health and shall include, but not be limited to:
(1) A loss of water supply that may result in adulteration of
				food;
(2) The use of an unapproved source of water within the
				facility;
(3) A failed sewer system or a sewage backup into the
				facility;
(4) A power outage that may result in adulteration of
				food;
(5) Information that indicates that food may have been
				intentionally adulterated;
(6) The facility has been subject to one or more of the
				following: flood, fire, chemical exposure, natural disaster, and/or other
				catastrophic event;
(7) An employee is found to be infected with a communicable
				disease as described in
				105 CMR
				500.008;
(8) A food-borne illness outbreak that appears to be associated
				with the facility;
(9) Severe unsanitary conditions that threaten to contaminate
				the facility, a part of the facility, or a particular product;
(10) Failure to comply with an order to correct a critical
				deficiency immediately;
(11) Failure to submit an approved correction plan for a
				critical deficiency in a timely manner;
(12) Failure to comply with an approved correction plan for a
				critical deficiency in a timely manner; or
(13) Failure to carry out a product recall as specified in
				105
				CMR 500.005(K).
The failure to include other violations, occurrences, 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.
Inedible
means adulterated or not
				intended for use as human food.
Inspector
means an agent of the
				Commissioner of the Massachusetts Department of Public Health, as defined in
				M.G.L. c. 111, § 9.
Juice
means the aqueous liquid
				expressed or extracted from one or more fruits or vegetables, purees of the
				edible portions of one or more fruits or vegetables, or any concentrates of
				such liquid or puree.
Landing
means that point in time when
				seafood has been brought on-shore after harvesting.
Law
means any applicable federal,
				state, or local statutes, ordinances, and regulations.
License
means any license or permit
				issued by the Department or by a board of health pursuant to
				105 CMR 500.000 and
				applicable statutes. License does not include a permit issued jointly by the
				Department and the Division of Marine Fisheries.
Licensee
means any person who holds a
				license or permit issued by the Department or by a board of health pursuant to
				105 CMR 500.000 and
				applicable statutes. Licensee does not include the holder of a permit issued
				jointly by the Department and the Division of Marine Fisheries.
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
				105 CMR 500.000, livestock
				includes so-called non-amenable animals raised for sale as food, including but
				not limited to buffalo, rabbits, frogs, and turtles.
Long Shelf-life Food
means a food
				product having an estimated shelf life of 90 days or more, including foods
				preserved by dehydration or packaged in a hermetically sealed container, but
				excluding frozen foods.
Major Food Allergen
means a major food
				allergen as defined by
				21 U.S.C. §
									321(qq).
Master Digger
means an individual
				holding a permit for the digging or taking of shellfish from an area determined
				under M.G.L. c. 130, § 74 to be contaminated.
Meat
, except as used in
				105 CMR
				500.020 through
				500.021,
				means the edible portion of livestock or wild-caught animals after
				slaughter.
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 CFR Part 317 .
Milk
means the lacteal secretion,
				practically free from colostrum, obtained by the complete milking of one or
				more healthy cows, goats, sheep, or other dairy animals.
Milk-based
means a product or
				ingredient derived from milk or a component of milk.
Minimal Treatment
means treatment of
				water for disinfection limited to the use of filters (paper, activated carbon,
				and/or particulate), ozonation, and/or the use of ultraviolet light. Any other
				treatment activity, including but not limited to ion exchange and reverse
				osmosis, is considered more than minimal treatment.
Misbranded Food
means the definition
				in M.G.L. c. 94, § 187.
Molluscan Shellfish
means all species
				of:
(1) Oysters, clams amd mussels, whether:
(a) Shucked or in the shell;
(b) Raw, including post harvest processed;
(c) Frozen or unfrozen; or
(d) Whole or in part; and
(2) Scallops in any form, except when the final product form is
				the adductor muscle only.
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:
(1) Engaging in any operation subject to regulation by
				105 CMR 500.000 or
				applicable statute, without a license, permit, or approval, whenever engaging
				in such an operation requires a license, permit, or approval.
(2) Engaging in any activity prohibited by, or not in
				compliance with,
				105 CMR 500.000 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 the Department pursuant to
				105 CMR 500.000 or
				applicable statute.
(3) Failing to do, or failing to do in a timely manner,
				anything required by
				105 CMR 500.000 or other
				applicable statute or regulation, or required by any order, license, permit,
				approval, certification, guideline, policy, or protocol issued by the
				Department pursuant to
				105 CMR 500.000 or
				applicable statute.
Non-molluscan Shellfish
means any type
				of shellfish not included in the National Shellfish Sanitation Program.
				Examples include but are not limited to crustaceans, conch, whelk, snails,
				periwinkles and shrimp.
Open Date
means a recommended last
				date of retail sale of a food product which provides for a reasonable
				subsequent period of home shelf life. An open date on a food package is
				preceded by terminology such as "sell by," "best by," "use by," or similar
				words.
Operations Water
means water that is
				delivered under pressure to a facility for container washing, hand washing,
				plant and equipment cleanup, and for other sanitary purposes.
Pasteurization Plant
means a facility
				for the pasteurization of milk.
Perishable Food
means a food product
				having an estimated shelf life of 60 days or less.
Permit
means a permit issued jointly
				by the Department and the Division of Marine Fisheries to a wholesale or retail
				seafood dealer or to a wholesale truck, pursuant to
				105 CMR
				500.020 and M.G.L. c. 130, § 80.
Permit Holder
means a person who holds
				a permit issued jointly by the Department and the Division of Marine Fisheries
				as a wholesale or retail seafood dealer or as a wholesale truck, pursuant to
				105 CMR
				500.020 and M.G.L. c. 130, § 80.
Permit Number
means the number
				assigned to a permit holder by the Division of Marine Fisheries.
Person
means any individual,
				partnership, corporation, association, or other legal entity.
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.
Potentially Hazardous Food (PHF)
means
				a food that requires time/temperature control for safety to limit pathogenic
				microorganism growth or toxin formation.
(1) Included are any foods of animal origin, either raw or
				heat-treated, and any foods of plant origin, which have been heat-treated, and
				raw seed sprouts.
(2) Excluded are the following:
(a) Air dried hard-boiled eggs with shells intact;
(b) Foods with a water activity (aw) value of 0.85 or
				less;
(c) Foods with a hydrogen ion concentration (pH) level of 4.6
				or below;
(d) Foods in unopened hermetically sealed containers, which
				have been commercially processed to achieve and maintain commercial sterility
				under conditions of nonrefrigerated storage and distribution; and
(e) Foods for which laboratory evidence acceptable to the
				Department demonstrates that rapid and progressive growth of infectious and
				toxigenic microorganisms or the slower growth of C. botulinum cannot occur.
Poultry
means any bird, whether live
				or dead, intended for use as food.
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
				CFR §
									381.15.
Prepackaged
means packaged prior to
				being displayed or offered for sale at retail or retail self-service.
Production Day
means a period of 24
				consecutive hours.
Program
means the Food Protection
				Program of the Massachusetts Department of Public Health.
Public Water System
means a system for
				the provision to the public of water for human consumption, as defined by
				42
				U.S.C. §
									300f, the Safe Drinking Water
				Act, in compliance with standards of the Massachusetts DEP or comparable
				standards of the state or foreign country where the public water system is
				located.
Reduced Oxygen Packaging
means the
				removal or partial removal of oxygen from a package, with or without replacing
				it with a gas mixture, to control food spoilage. Reduced Oxygen Packaging (ROP)
				includes controlled atmospheric packaging (CAP), modified atmospheric packaging
				(MAP), straight vacuum packaging (VP), sous vide and cook-chill.
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.
Regulatory Agency
means the Department
				of Public Health (Food Protection Program) and/or the board of health, as
				applicable.
Remodel
means to make a material
				change to the facility.
Residential Kitchen
means a kitchen in
				a private home that processes food for sale at wholesale.
Retail
means sale to the ultimate
				consumer.
Retail Seafood Dealer
means a person
				who sells raw, fresh, or frozen seafood directly to the consumer.
Ritual Slaughter
means slaughter in
				accordance with the ritual requirements of the Jewish faith or any other
				religious faith that prescribes a method of slaughter whereby the animal
				suffers loss of consciousness by anemia of the brain caused by the simultaneous
				and instantaneous severance of the carotid arteries with a sharp
				instrument.
Seafood
means all fish and/or fishery
				products.
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.
Semi-perishable Food
means a food
				product having an estimated shelf life greater than 60 days but less than 90
				days.
Shelf Life
means a period of time
				after the date of packaging during which a food product has no significant risk
				of spoilage, loss of nutritional value, or loss of palatability, given
				compliance with recommended conditions of storage and handling as disclosed on
				the label of such product.
Shellfish
means molluscan shellfish,
				whether alive or shucked.
Shellfish Transaction Card
means a
				card issued by the Division of Marine Fisheries to a permitted shellfish
				harvester to be used in connection with each sale of shellfish by the harvester
				to a wholesale dealer.
Shellstock
means live shellfish in the
				shell.
Shucked Shellfish
means shellfish that
				have one or both shells removed.
Slaughter
means the act of killing
				livestock or poultry for human food.
Soft-serve Machine
means any equipment
				used in the conversion of milk-based frozen dessert mix into frozen desserts
				for sale at retail.
Source Approval
means approval by the
				Department, with or without conditions, of a water source, of substantial
				modification of a water source, of treatment of source water, and/or of
				substantial modification of treatment of source water, for use in a facility
				producing bottled water or carbonated non-alcoholic beverages, or for use in
				water vending, or for sale as bulk water for bottling.
See
105
				CMR 500.091.
Substantial Modification
of a water
				source or treatment of source water means any deviation from approved plans or
				specifications affecting capacity, hydraulic conditions, operating units, the
				functioning of water treatment processes or systems, the source, or the quality
				of water delivered to a facility that manufactures, collects, and bottles water
				or carbonated non-alcoholic beverages.
Transaction Slip
means a serialized
				multi-copy form approved by the Department used by wholesale dealers to record
				original shellfish purchase transactions by mechanical imprinting (or by
				another means approved by the Department and the Division of Marine Fisheries)
				from the Shellfish Transaction Card.
USDA
means the United States
				Department of Agriculture.
Water Source
means any ground or
				surface water body and the site from which water is withdrawn.
Wholesale
means sale to other than the
				ultimate consumer.
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.
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.