FOOD LICENSING AND INSPECTION

1. DEFINITIONS2. CURRENT FOOD MANUFACTURING PRACTICE3. PLANT AND GROUNDS4. EQUIPMENT AND UTENSILS5. SANITARY FACILITIES AND CONTROLS6. SANITARY OPERATIONS7. PROCESSES AND CONTROLS8. PERSONNEL

1. DEFINITIONS- the definitions and interpretations contained in section 10 of the Food, Drug and Cosmetic Act (R.A 3720) are applicable to such terms when used in this part. The following shall also apply.

(a) "Board" means the Board of Food and Drug Inspection.

(b) "Secretary" means the Secretary of Health.

(c) "Department" means the Department of Health.

(d) "Person" includes individual, partnership, corporation and association.

(e) "Food" means (1) articles used for food or drink for man, (2) chewing gum, and (3) articles used for components of any such article.

(f) "Drug" means (1) articles recognized in the

official United States Pharmacopoeia, official

Homeopathic Pharmacopoeia of the United

States, or official National Formulary, or any

supplement to any of them; and (2) articles

intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of disease in

man or other animals; and (3) articles (other

than food) intended to affect the structure or any

function of the body of man or animals; and (4)

articles intended for use as a component of any

articles specified in clauses (1), (2), or (3), but

not include devices or their components, parts,

or accessories.

(g) "Device" means instruments, apparatus, or contrivances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or (2) to affect the structure or any function of the body of man or animals.

(h) "Cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles.

(i) "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 this Act that any word, statement, or other information appearing 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.

(j) "Immediate container" does not include package liners.

(k) "Labelling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

(l) "New drugs" mean:

(1) any drug the composition of which is such that said drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof.

(2) any drug the composition of which is such that said drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

(m) If an article is alleged to be misbranded because the labeling is misleading, then in determining whether the labeling is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual.

(n) "Food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use.

(o) “Adequate” means that which is needed to accomplish the intended purpose in keeping with good public health practice.

(p) “Plant” means that building or buildings or parts thereof, used for in connection with the manufacturing, processing, packaging, labelling or holding of human food.

(q) “ Sanitize” means adequate treatment of surfaces by a process that is effective in destroying vegetative cells of pathogenic bacteria in substantially reducing other microorganisms. Such treatment shall not adversely affect the product and shall be safe for the consumer.

2. CURRENT FOOD MANUFACTURING PRACTICE (SANITATION).

The criteria in paragraph 3 through 8 shall apply in determining whether the facilities, methods, practices, and controls used in the manufacture, processing, packing, or holding of food are in conformance with or are operated or administered in conformity with good manufacturing practices to assure that food for human consumption is safe and has been prepared, packed, and held under sanitary conditions.

3. PLANT AND GROUNDS

A. Grounds.

The grounds about a food plant under the control of the operator shall be free from conditions which may result in the contamination of food including, but not limited to, the following:

1. Improperly stored equipment, litter, waste, refuse and uncut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harbourage for rodents, insects and other pests.

2. Excessively dusty roads, yards, or parking lots that may constitute a source of contamination in areas where food is exposed. 3. Inadequately drained areas that may contribute contamination to food products through seepage or foot-borne filth and by providing a breeding place for insects or micro-organisms.

B. Plant construction and design.

Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food processing purposes. The plant and facilities shall:

1.) Provide sufficient space for such placement of equipment and storage of materials as is necessary for sanitary operations and productions of safe food. Floors, walls, and ceilings in the plant shall be of such construction as to be adequately cleanable and shall be kept clean and in good repair. Fixtures, ducts, and pipes shall not be so suspended over working areas that drip or condensate may contaminate foods, raw materials, or food-contact surfaces. Aisles or working spaces between equipment and between equipment and walls shall be unobstructed and of sufficient width to permit employees to perform their duties without contamination of food or food-contact surfaces with clothing or personal contact.

2.) Provide separation by partition, location, or other effective means for those operations which may cause contamination of food products with undesirable micro-organisms, chemicals, filth, or other extraneous material.

3. Provide adequate lighting to hand-washing areas, dressing and locker rooms, and toilet rooms and to all areas where food or food ingredients and utensils are cleaned. 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.

4. Provide adequate ventilation or control equipment to minimize odors and noxious fumes or vapors (including steam) in areas where they may contaminate food. Such ventilation or control equipment shall not create conditions that may contribute to food contamination by airborne contaminants.  5. Provide, where necessary, effective screening or other protection against bird, animals, and vermin (including, but not limited to, insects and rodents).

4. EQUIPMENT AND UTENSILS

 All plants must be (a) suitable for their intended use, (b) so designed and of such material and workmanship as to be adequately cleanable, and (c) properly maintained. The design, construction, and use of such equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water of any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces.

5. SANITARY FACILITIES AND CONTROLSa. Water supply - The water supply shall be sufficient for the operations intended and shall be derived from an adequate source. Any water that contacts food or food contact surfaces shall be safe and of adequate sanitary quality. Running water at a suitable

temperature, and under pressure as needed, shall be provided in all areas where

required for the processing of food, for the cleaning of equipment, utensils, and food packaging materials, or for employee sanitary facilities.

b. Sewage disposal - Sewage disposal shall be made into an adequate sewerage system or disposed of through adequate means.A food processing or storage facility will produce both human waste and liquid processing waste that must be separated and disposed properly. Failure to use an adequate sewage disposal system can lead to contamination in or outside of the plant that could lead to contamination of the facility and the food you produce.

c. Plumbing - plumbing shall be of adequate size and design and adequately installed and maintained to:

1. Carry sufficient quantities of water to required locations throughout the plant.

2. Properly convey sewage and liquid disposable waste from the plant.

3. Avoid being a source of contamination to food, water supplies, equipment or utensils or creating an unsanitary condition.

4. Provide adequate floor drainage in all areas where floors are subject to flooding type cleaning or where normal operations release or discharge water or other liquid waste on the floor.

5. Provide that there is no backflow from, or cross connection between, piping systems that discharge waste-water or sewage and piping systems that carry water for food or food manufacturing.

d. Toilet Facilities - Each plant shall provide its employees with adequate, readily accessible toilet facilities. Compliance with this requirement may be accomplished by:

1. Maintaining the facilities in sanitary condition.

2. Keeping the facilities in good repair at all times.

3. Providing self-closing doors that do not open into areas where food is exposed.

4. Providing doors that do not open into areas where food is exposed to airborne contamination, except where alternate means have been taken to protect against airborne contamination such as double doors or positive air flow systems.

UNACCEPTABLE

ACCEPTABLE

e. Hand-washing facilities – Adequate and convenient facilities for hand washing and where appropriate, hand sanitizing shall be provided at each location in the plant where good sanitary practices require employees to wash or sanitize and dry their hands.

f. Rubbish and offal disposal

6. SANITARY OPERATIONS

a. General Maintenance – Building fixtures and other physical facilities of the plant shall be kept in good repair and shall be maintained in a sanitary condition.

b. Animal and vermin control – No animals or birds, other than those essentials as raw materials shall be allowed in any area of a food plant.

c. Sanitation of Equipment and Utensils – All utensils and product-contact surfaces or equipment shall be cleaned as frequently as necessary to prevent contamination of food and food products

d. Storage and handling of cleaned portable equipments and utensils.

7. PROCESSES AND CONTROLS

All operations in the receiving, inspecting, transporting, packaging, segregating, preparing, processing, and storing of food shall be conducted in accord with adequate sanitation principles.

In order to assure that production procedure do not contribute to contamination, the following must be done:

a. Raw materials and ingredients shall be inspected and segregated as necessary to assure that they are clean, wholesome, and fit for processing into human food.

b. Containers and carriers of raw ingredients should be inspected on receipt to assure that their condition has not contributed to the contamination or deterioration of the products.

c. .When ice is used in contact with food product, it shall be made from potable water.

d. Food processing areas and equipment used for processing human food should not be used to process non-human food-grade animal feed or inedible products unless there is no reasonable possibility for the contamination of the human food.

e. Processing equipment shall be maintained in a sanitary condition through frequent cleaning including sanitation where indicated.

f. All food processing, including packaging and storage, should be conducted under such conditions and controls as are necessary to minimize the potential for undesirable contamination of the processed product or ingredients.

g. Chemical microbiological, or extraneous-material testing procedures shall be utilized where necessary to identify sanitation failures or food contamination, and all foods and ingredients that have become contaminated shall be rejected or treated or processed to eliminate the contamination where this may be properly accomplished.

h. Packaging processes and materials shall not transmit contaminats or objectionable substances to the products, shall conform to any applicable food additive regulation and should provide adequate protection from contamination.

i. Meaningful coding of products sold should be utilized to enable positive lot identification to facilitate, where necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use.

Storage and transportation of finished products should be under such conditions.

8. PERSONNEL

» The Plant management shall

take all reasonable measures

and precautions to assure the

following :

A. DISEASE CONTROL

No person affected by disease in a communicable form or while a carrier of such diseases, or while affected with boils, sores, infected wounds, or other abnormal sources of microbiological contamination , shall work in a food plant in any capacity in which there is a reasonable possibility of food or food ingredients becoming contaminated by such person, or of disease being transmitted by such person to other individuals.

B. CLEANLINESSAll persons, while

working in direct contact with food preparation, food ingredients, or surfaces coming into contact therewith shall:

1. Wear clean outer garments, maintain high degree of personal cleanliness and conform to hygienic practice while on duty.

2. Wash hands thoroughly in an adequate hand-washing facility before starting to work.

3. Remove all insecure jewelry and during periods where food is manipulated by hand.

4. If gloves are used in food handling, maintain then in an intact, clean and sanitary condition.

5. Wear hairnets, headbands, caps or other effective hair restraints.

6. Not store clothing or other personal belongings, eat food or drink beverages or use tobacco in any form in areas where food or food ingredients are exposed or in area used for washing equipment or utensils.

7. Take any other necessary precautions to prevent contamination of the food.

C. Education and training Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experiences of a combination thereof, to provide a level of competency necessary for production of clean and safe food.

D. Supervision

Responsibility for assuring compliance by all personnel with all the requirements.