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Good Manufacturing Practices for Food Rule

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Good Manufacturing Practices for Food Rule Chapter 5 – Food Safety Rules Subchapter 1 GOOD MANUFACTURING PRACTICES FOR FOOD RULE 1.0 Authority This rule is adopted pursuant to 18 V.S.A. Chapter 85. 2.0 Purpose This rule provides the requirements for the safe and sanitary manufacturing, packing or holding of human food products. 3.0 Scope This rule applies to food establishments that process food for human consumption, and provide processed food for sale and distribution to other business entities such as other food establishments. Requirements do not pertain to food establishments that process food solely under the regulatory oversight of the Vermont Agency of Agriculture, Food, & Markets. 4.0 Definitions Whenever used in these Regulations, the following terms shall be construed as follows: 4.1 “Acid foods or acidified food” means foods that have an equilibrium pH of 4.6 or below. 4.2 “Adequate” means that which is needed to accomplish the intended purpose in keeping with good public health practices. 4.3 “Batter” means a semi-fluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods. 4.4 “Blanching, except for tree nuts and peanuts” means a prepackaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food. 4.5 “Critical control point” means a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or to filth in the final food or decomposition of the final food. 4.6 “Department” means the Vermont Department of Health. 4.7 “Commissioner” means the Commissioner for the Vermont Department of Health or a subordinate to whom the commissioner has assigned his or her Good Manufacturing Practices for Food Rule Page 1 of 19 Effective 3/14/2015 functions. 4.8 “FDA” means the U.S. Food and Drug Administration. 4.9 “Food” means any article used or intended to be used by human beings for food, drink, confection, or condiment, whether simple, mixed, or compound and all substances and ingredients used in the preparation thereof. 4.10 “Food-contact surfaces” are those surfaces that contact human food and those surfaces from which drainage onto surfaces that contact the food ordinarily occurs during the normal course of operations. Food-contact surfaces include utensils and food-contact surfaces of equipment. 4.11 “Lot” means the food produced during a period of time indicated by a specific code. 4.12 “Low-acid food” means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85. Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods. 4.13 “Microorganisms” means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance. The term “undesirable microorganisms” includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of these Regulations. 4.14 “Pasteurize” means to expose food to an elevated temperature for a period of time sufficient to destroy certain microorganisms that can produce disease or cause spoilage or undesirable fermentation of food. 4.15 “Pest” means any objectionable animals or insects including, but not limited to, birds, rodents, flies, and larvae. 4.16 “Plan review” means the submission of blueprints, drawings, or plans for proposed new construction, renovation, or remodeling of a food processing facility. 4.17 “Plant” means the building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food. 4.18 “Process Authority Review” means a product review conducted by a person(s) or organization(s) having expert knowledge of thermal processing requirements for foods in hermetically sealed containers, having access to facilities for making such determinations, and designated by the establishment to perform certain functions. 4.19 “Processed food” means any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, grinding, churning, separating, extracting, packaging, or milling, but does not mean the sorting, trimming, cleaning, or water-rinsing of food. Good Manufacturing Practices for Food Rule Page 2 of 19 Effective 3/14/2015 4.20 “Quality control operation” means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated within the meaning of these Regulations. 4.21 “Rework” means clean, unadulterated food that has been removed from processing for reasons other than unsanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food. 4.22 “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. 4.23 “Safe-moisture level” is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, storage, and distribution. The maximum safe moisture level for a food is based on its water activity (aw). An aw will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given aw will not support the growth of undesirable microorganisms. 4.24 “Sanitize” means to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. 4.25 “Significant renovation” means a physical change to a facility or portion of a facility, including the following: 4.25.1 Replacing or upgrading any major system, such as the electrical, plumbing, heating, ventilation, or air-conditioning systems; 4.25.2 Demolition of the interior or exterior of a building or portion of the building; and 4.25.3 Replacement, demolition, or installation of interior walls and partitions, whether fixed or movable. 4.26 “Water activity (aw)” means a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature. 5.0 License Requirements 5.1 A person shall not maintain or operate a food processing or manufacturing facility or food warehouse unless such establishment is licensed pursuant to the provisions of 18 V.S.A. §4351. 5.1.1 Each individual establishment shall require a separate license, regardless of ownership. A food license expires annually, unless sooner revoked by the Department. Good Manufacturing Practices for Food Rule Page 3 of 19 Effective 3/14/2015 5.2 A completed Application for License to Operate a Food And Lodging Establishment, a check or money order for the applicable fees determined in 18 V.S.A. §4353, and copies of all other required documentation and permits must be submitted to the Department for review no less than 30 days before the expected start of operation. 5.3 Additional documentation, when applicable and requested by the Department, including but not limited to: 5.3.1 Wastewater system documentation and permits from the Vermont Agency of Natural Resources; 5.3.2 Water system documentation for water systems requiring a permit; 5.3.3 Local permit or zoning approval for proposed operation; 5.3.4 Documentation of Process Authority Review for low-acid canned foods, acidified foods, and products where the Department has requested documentation that there are no biological concerns with the food production process. 5.4 Establishments shall submit a plan review prior to any new construction or significant renovation of an existing facility. 5.5 Transference of Licenses 5.5.1 A license shall not be transferred from one person or corporation to another. 5.5.2 When a licensed establishment is sold, the corporation changes, or the establishment relocates or enlarges its operation, the license held by the former entity or person shall be returned to the Department. 5.5.3 The new proprietor or management must apply for and receive a license before operating the business. 5.6 A variance may be granted by the Commissioner to modify or waive one or more requirements of this rule if the Commissioner determines that a health hazard, safety hazard, or nuisance will not result from the variance. 5.6.1 Each person requesting a variance shall submit the following to the department: 5.6.1.1 A written statement of the proposed variance of the regulatory requirement; 5.6.1.2 Documentation of how the proposed variance addresses public health hazards at the same level of protection as that of the original requirement; and 5.6.1.3 Any other relevant information if required by the Commissioner. 5.6.2 For each variance granted, the licensee shall meet the following requirements: 5.6.2.1 Follow the plans and procedures approved by the Commissioner; Good Manufacturing Practices for Food Rule Page 4 of 19 Effective 3/14/2015 5.6.2.2 Maintain a permanent record of the variance at the establishment; and 5.6.2.3 Maintain and provide to the Commissioner, upon request, records that demonstrate that the variance is being followed.
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