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