01-001 DEPARTMENT OF AGRICULTURE, CO NSERVATION AND FORESTRY

1. DIVISION OF REGULATIONS
   1. Chapter 343: FOOD PROCESSING AND MANUFACTURING

SUMMARY: The purpose of this chapter is to set forth standards for licensing and regulations for food manufacturing and processing establishments, including shellfish processing.

1. 1. Definitions

   For purposes of this chapter and unless the context otherwise indicates, the following words shall have the following meanings.

   1. A. “Adequate" means that which is needed to accomplish the intended purpose in keeping with good public health practice.
   2. B. “Building" means the building or buildings or parts thereof, used for or in connection with, the manufacturing, processing, packaging, labeling or holding of human food.
   3. C. “Corrosion resistant material" means those materials that maintain their original surface characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and bactericidal solutions, and other conditions of the environment.
   4. D. “Department" means the Maine Department of Agriculture, Conservation and Forestry.
   5. E. “Easily cleanable" means readily accessible and of such material and finish and so fabricated, that residues may be completely removed by usual cleaning methods.
   6. F. “Food" means any article used or intended to be used by human beings for food, drink, confection or condiment, whether simple or compound or any part or ingredient thereof or the preparation thereof.
   7. G. “Food contact surfaces" means those surfaces of equipment and utensils with which food normally comes in contact.
   8. H. “Food processing and manufacturing" means an establishment in which food is processed or otherwise prepared and packaged for human consumption.
   9. I. “Perishable food" means any food of such type or in such condition or physical state as it may spoil or otherwise become unfit for human food.
   10. J. “Potentially hazardous food" means any perishable food which consists in whole or in part, of milk or milk products, eggs, meat, poultry, fish, shellfish or other ingredients capable of supporting rapid and progressive growth of infectious or toxigenic microorganisms.
   11. K. “Safe temperatures" as applied to potentially hazardous food means air temperature of 45 F or below and 140 F or above.
   12. L. “Sanitary" means that all buildings, equipment, and utensils shall be suitable for their intended use, so designed and of such material and workmanship as to be adequately cleanable and properly maintained.
   13. M. “Wholesome" means food in sound condition, clean, free from adulteration and otherwise suitable for human consumption.
2. 2. Premises

   The grounds of the outer building or buildings shall be reasonably clean and well drained, free from any materials or conditions that create rodent, bird and/or insect harborages and free from other nuisances and sources of contamination.

3. 3. Plant Construction and Design
   1. A. Floors, walls and ceilings shall be constructed so as to be readily cleanable and shall be kept clean and in good repair.
   2. B. Fixtures, ducts, pipes shall not be suspended over working areas in a manner whereby drip may contaminate foods, raw materials or equipment.
   3. C. Operations which may cause cross-contamination with bacteria, molds, toxic chemicals, filth, or the like shall be separated by partitions or located in different parts of the plant.
   4. D. Adequate lighting shall be provided where food or food ingredients are stored, processed or examined. Where equipment or utensils are washed, and in handwashing areas, dressing and locker rooms and toilets.
   5. E. Light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation, shall be of the safety type or otherwise protected to prevent food contamination in case of breakage.
   6. F. Adequate ventilation shall be provided to eliminate objectionable odors and vapors, including steam, and constructed in such a manner as to avoid possible airborne contamination.
   7. G. Adequate facilities for employees to eat lunches and hang clothing to prevent food contamination or contamination of food contact surfaces.
   8. H. Adequate screening, where necessary, shall be provided to exclude birds, dogs, flies and other vermin and rodents.
4. 4. Equipment and Utensils
   1. A. Equipment and utensils shall be adequate for their intended use.
   2. B. Equipment and utensils shall be designed and constructed to enable easy cleaning and maintenance.
   3. C. Equipment shall not contaminate food with lubricants, fuel, metal fragments, contaminated water and the like.
5. 5. Cleaning and Sanitization of Food Contact Surfaces
   1. A. All equipment and utensils shall be maintained in a sanitary condition through cleaning at frequent intervals to prevent contamination of food and food products.
   2. B. Suitable facilities for cleaning equipment and utensils shall be provided at convenient locations.
   3. C. All food contact surfaces shall be cleaned and sanitized prior to use and following any interruption during which such utensils and contact surfaces may have become contaminated. Where such equipment and utensils are used in a continuous production operation, the contact surfaces of such equipment and utensils shall be cleaned and sanitized on a predetermined schedule using adequate methods for cleaning and sanitizing. Sanitizing agents shall be effective and safe under conditions of use.
   4. D. Sanitization shall be accomplished by one of the following methods; (1) immersion for at least one-half () minute in clean, hot water at a temperature of at least 170 F; or (2) immersion for at least one minute in a clean solution containing at least 50 parts per million of available chlorine as a hypochlorite and at a temperature of at least 75 F; or (3) immersion for at least one minute in a clean solution containing at least 12.5 parts per million of available iodine and having a pH not higher than 5.0 and at a temperature of at least 75 F. Where both cleaning and sanitation are required, sanitation shall follow cleaning. Utensils and product contact surfaces of equipment which cannot be immersed shall be sanitized by rinsing with one of the three solutions described in this paragraph.
   5. E. All cleaned and sanitized portable equipment and utensils shall be stored above the floor in a clean and dry location in such a manner that all food contact surfaces are protected from splash, dust or other contamination.
6. 6. Sanitary Operations and Controls
   1. A. The water supply shall be ample for operations, and shall be of safe and sanitary quality. Water may be drawn from a public or private supply. Private water supplies shall be tested yearly.
   2. B. Hot and cold running water under pressure shall be provided in all areas where foods are processed. Only a two bay sink made of corrosion resistant material shall be used for washing equipment and utensils.
   3. C. Sewage disposal shall be made into a public sewerage system or into an adequate private sewerage system.
   4. D. Adequate floor drains shall be provided in areas where floors are subjected to flooding type of cleaning or where there is release or discharge of water or waste onto the floor.
   5. E. Toilets shall be adequate for the number of employees and have self-closing doors not opening directly into any rooms used for processing or packaging. Handwashing facilities shall be adequate and conveniently located in relation to the toilet and food processing area. Soap or detergent, and paper towels or other one use drying devices, shall be provided at all times. Toilet and handwashing facilities shall be maintained in a clean and sanitary condition. Handwash signs shall be posted. The toilet room shall be ventilated to the outside, kept free of odors, clean and in good repair.
   6. F. Offal and rubbish shall be conveyed, disposed of or stored in such a manner as to minimize the development of odor, prevent waste from becoming an attractant, harborage or breeding place for vermin and flies and prevent contamination of food, food contact surfaces and water supply.
   7. G. Effective measures shall be taken to protect against contamination of food in or on the premises by cats, dogs. birds, rodents or insects.
   8. H. Buildings, fixtures and other physical facilities shall be kept in good repair and maintained in an orderly, sanitary condition at all times.
   9. I. Cleaning operations shall be conducted in such a manner as to minimize food contamination or the contamination of food contact surfaces.
   10. J. Only detergents, disinfectants and other cleaning supplies contained in the current List of Chemical Compounds, Authorized for use under U.S.D.A. Inspection and Grading Programs shall be used in food manufacturing and processing facilities. Such detergents, disinfectants, and cleaning supplies shall be used only for their approved purposes as noted in the List.
7. 7. Processes and Controls
   1. A. Raw materials and ingredients received in bulk or enclosed containers shall be inspected on receipt and segregated as necessary to assure that they are clean, wholesome and fit for processing into human food. They shall be stored under conditions which will protect against contamination and deterioration.
   2. B. Containers and carriers of raw materials shall be inspected on receipt to assure that their condition has not contributed to contamination or deterioration of the product.
   3. C. Any ice used in contact with the product shall be made from potable water and manufactured in accordance with adequate standards. It shall be stored, transported and handled in a sanitary manner.
   4. D. Food processing areas and equipment used for the processing of human food shall not be used in the processing of animal feed or inedible products unless such use cannot result in the contamination of human food.
   5. E. Processing equipment shall be maintained in a sanitary condition through frequent cleaning and shall be sanitized where necessary.
   6. F. Chemical, microbiological or extraneous testing procedures shall be utilized where necessary to identify sanitation failures or food adulterants.
   7. G. Packaging processes or materials shall not transmit contaminants or objectionable substance to the product.
   8. H. Processors and manufacturers shall keep records and code products so as to enable them to identify specific food lots affected by contamination, spoilage or by sanitation failure and shall separate each lot from non-affected.
   9. I. Finished products shall be stored and transported under conditions which will preclude all contamination and protect against deterioration of the product and the container.
8. 8. Personnel
   1. A. Employees shall wear clean outer garments and maintain a high degree of personal cleanliness, and wear hair nets, headbands, caps or effective hair restraints, in processing and manufacturing areas.
   2. B. Remove all jewelry, excepting wedding rings but including wrist watches, during periods in which food components are manipulated by hand.
   3. C. Wash hands thoroughly in an adequate handwashing facility before starting work, after each absence from work station, and after any other time when the hands have become soiled or contaminated.
   4. D. Maintain gloves used in food handling in an intact, clean and sanitary condition. Such gloves shall be of an impermeable material except where their usage would be inappropriate or incompatible with the work involved.
9. 9. Tobacco

   No person shall use tobacco in any form in food processing, food handling and equipment/utensil washing areas.

10. 10. Licensing
    1. A. Application and Fee. Application for approval of Food Processing And Manufacturing establishments shall be filed annually with the Department of Agriculture, Food and Conservation and Forestry. Applications shall be accompanied by the appropriate fee as enumerated in Chapter 330, License Fees to Manufacture and Sell Food & Beverages. In order to allow for the staggering of license expiration dates, initial licenses may be issued for a period exceeding twelve months. In such cases, the initial license fee shall be increased in proportion to the length of the license period.
    2. B. Inspection and Issuance. Before a license is issued or renewed the Department shall inspect the premises of the applicant.

       The commissioner shall, within 30 days following receipt of application, issue a license to operate any food establishment which is found to comply with this chapter and any rules and regulations adopted by the commissioner. When any such applicant, upon inspection by the commissioner, is found not to meet the requirements of this chapter or regulations adopted hereunder, the commissioner is authorized to issue either a temporary license for a specified period not to exceed 90 days, during which time corrections specified by the commissioner shall be made by the applicant for compliance or a conditional license setting forth conditions which shall be met by the applicant to the satisfaction of the commissioner.

    3. C. Display. Licenses issued shall be displayed in a place visible to consumers or other persons using a licensed establishment.
    4. D. Warehouses within the food processing and manufacturing establishments shall comply with 01-001 CMR Chapter (Food Storage Warehouse), but only one fee need be paid.

STATUTORY AUTHORITY: 22 MRSA 2167, 2168 and 2169

EFFECTIVE DATE:

December 9, 1980

EFFECTIVE DATE (ELECTRONIC CONVERSION):

May 4, 1996

CONVERTED TO MS WORD:

April 15, 2008

AMENDED:

September 21, 2008 – Section 10(A), filing 2008-431

CORRECTIONS:

February, 2014 – agency names, formatting

WORD VERSION CONVERSION AND ACCESSIBILITY CHECK: July 10, 2025