Food manufacturing plants: the physical plant, the water and the sanitary controls

It is Rule 4.3.6 of Chapter 4.3 of Joint Regulation No. 9473, the Health Licence chapter, with its two sections: 4.3.6.1 on buildings and installations — the physical plant and the plant’s design and construction — and 4.3.6.2 on sanitary installations and controls — water supply, plumbing, used-water disposal, sanitary installations, self-closing doors, handwashing installations, and waste and residues. This site already has a guide to Rule 4.3.5, which covers establishments where food is served or prepared for direct consumption; this one covers plants that manufacture it.

The rule applies to establishments where food is manufactured. Several of its provisions have a specific addressee: those on external fermentation vessels apply to whoever uses them; the one on adjoining land applies where that land is not under the operator’s control and is not adequately maintained; and the one on sanitising signs applies to employees who handle food directly with their hands, who handle packaging materials, food-contact surfaces or surfaces to be cleaned.

• Keeping the physical plant in a condition allowing the food to be protected from contamination, including adequate storage, waste removal and maintenance of the grass and the surroundings in the building’s immediate vicinity.Verified against the official source
• Keeping the streets, yards and parking so they do not become sources of contamination for the areas where food is exposed, and having adequate drainage areas that do not contribute to contamination through seepage or through the dirt arriving on shoes.Verified against the official source
• Designing the plant to separate operations in which contamination may occur, by location, time, separation, air flow, closed systems or other effective means.Verified against the official source
• Providing space between equipment and walls, unobstructed and of a width letting the employee carry out cleaning tasks, and preventing seepage or condensation from apparatus, ducts and pipes from contaminating the food or the surfaces in contact with it.Verified against the official source
• Providing adequate lighting in the handwashing areas, changing rooms, lockers, bathrooms and in every area where food is examined, processed or stored, with safety bulbs or lamps, and protection against any suspended glass that could break over exposed food.Verified against the official source
• Providing running water at an adequate temperature, with adequate pressure, in every area where it is required for food processing, cleaning equipment, utensils and packaging materials, or for the employees’ sanitary installations, and coming from an adequate source.Verified against the official source
• Ensuring there is no backflow or cross-connection between the potable water piping and that of used water, and providing adequate floor drainage in all areas subject to cleaning with abundant water.Verified against the official source
• Providing doors that do not open onto areas where food is exposed to contamination by air, except where alternative means such as double doors or positive-air-flow systems are provided.Verified against the official source
• Placing clear and legible signs directed at employees who handle food, packaging materials or surfaces, requiring hand sanitising before starting work, after being away from their workplace and when their hands become dirty or contaminated.Verified against the official source

Information pending verification.

1. 1

   Step 1: The grass, the parking and the neighbour’s land

   The rule opens where nobody expects: outside the building. The physical plant must be kept in a condition allowing the food to be protected from contamination, and the methods include adequate storage equipment, waste removal and maintenance of the grass and the surroundings in the immediate vicinity of the building and its structures, since these can become areas where insects and rodents proliferate. Also maintenance of the streets, yards and parking so they do not become sources of contamination for the areas where food is exposed; adequate drainage areas so they do not contribute to contaminating the food through seepage, through the dirt arriving on shoes, or by becoming a place where pests proliferate; and operational systems for treating waste and disposing of it adequately. And the awkward case: if the installations are surrounded by land not under the operator’s control and not adequately maintained, the necessary measures must be taken — plant inspection, extermination and any other means preventing pests, dust, dirt or other contaminants from affecting the food supply.

2. 2

   Step 2: Separating the operations that can contaminate

   The plant’s installations and structures must be of adequate size, built and designed so as to facilitate maintenance and the sanitary procedures. They must provide sufficient space for siting equipment and storing materials as needed to maintain the sanitary operations and produce a safe product. And the design must allow appropriate precautions to be taken to reduce the potential for contaminating the food and the food-contact surfaces, or contamination with microorganisms, chemicals, foreign or dirty matter from packaging materials. The regulation names the mechanisms: adequate food-safety controls and operational practices, or an effective design including the separation of operations in which contamination may occur, by location, time, separation, air flow, closed systems or other effective means.

3. 3

   Step 3: The external fermentation vessels

   The design must allow appropriate precautions to be taken to protect food in external fermentation vessels by any means, and the regulation lists four: the use of protective covers; control areas on and around the vessels to eliminate pest proliferation; frequent checking to prevent pest infestation; and removing residues from the fermentation vessels as needed. It is the only part of the rule dedicated to a particular piece of equipment, and it applies to whoever has one.

4. 4

   Step 4: Floors, walls, ceilings and the space to clean

   The plant must be built so floors, walls and ceilings can be cleaned and kept in good condition; so seepage or condensation from apparatus, ducts and pipes does not contaminate the food, the food-contact surfaces or the packaging materials; so space is provided between equipment and walls, unobstructed and of a width letting the employee carry out cleaning tasks; and so the food and surfaces are protected against contact with the employee and their clothing. That point about the space between equipment and wall is the one most overlooked when setting up a production line, and it is the one that later makes cleaning impossible.

5. 5

   Step 5: Lighting, safety bulbs and ventilation

   Adequate lighting must be provided in the handwashing areas, changing rooms and lockers, in the bathrooms and in every area where food is examined, processed or stored and where equipment and utensils are sanitised. Safety bulbs or lamps must be provided, and protection against any other suspended glass that could break over exposed food at any step of the preparation. Adequate ventilation or control equipment must be provided to minimise objectionable odours and vapours in areas where they could contaminate food; and fans and analogous equipment must be sited and operated so as to minimise the potential for contaminating the food, the packaging materials and the food-contact surfaces. And, where necessary, screening and other protection against pests must be provided.

6. 6

   Step 6: The plant’s water and plumbing

   The water supply must be sufficient for the operation’s purpose and must come from an adequate source; any water contacting food or food-contact surfaces must be safe and of adequate sanitary quality. Running water at an adequate temperature, with adequate pressure as needed, must be provided in every area where it is required for food processing, for cleaning equipment, utensils and packaging materials, or for the employees’ sanitary installations. The plumbing must be of adequate size and designed, installed and maintained under the current Puerto Rico Plumbing Code; provide sufficient water for all the premises throughout the plant; adequately dispose of used water and solid waste outside the plant; avoid causing sources of contamination for the food, the water supply, the equipment and utensils, or creating unsanitary conditions; provide adequate floor drainage in all areas subject to cleaning with abundant water or where normal operations discharge water or other liquids on the ground; and ensure there is no backflow or cross-connection between the potable water piping and that of used water. Used water must be discharged into a sewer system or an adequate individual disposal system.

7. 7

   Step 7: The doors that may not open onto exposed food

   Each plant must provide employees with adequate and accessible sanitary installations, kept in optimal sanitary conditions and in good repair at all times. And self-closing doors must be provided: doors that do not open onto areas where food is exposed to contamination by air, except where alternative means to protect from such contamination are provided, such as double doors or positive-air-flow systems. It is a design requirement, not an operating one, and that is why it is best resolved on the plans.

8. 8

   Step 8: Handwashing and the signs for employees

   The handwashing installations must be adequate and convenient, and provided with running water at an adequate temperature. The regulation details six things. Washing and, where appropriate, hand-sanitising installations in every premises in the plant where good hygiene practices require the employee to wash or sanitise their hands. Preparations for effective hand cleaning and sanitising. Paper towel service or hand-drying fittings. Fittings or devices such as water control valves, designed and built so as to protect against the recontamination of clean and sanitised hands. Clear and legible signs directed at employees who handle food directly with their hands, handle packaging materials and food-contact surfaces or surfaces to be cleaned, requiring hand sanitising before they start work, after being away from their workplace and when their hands become dirty or contaminated; those signs may be placed in the processing room or rooms and in every area where employees may handle such foods, materials and surfaces. And waste receptacles built and maintained so as to protect against contamination.

9. 9

   Step 9: The process’s waste and residues

   Process waste and residues must be disposed of so as to minimise the development of odours and minimise their potential to attract pests and contaminate the food, the food-contact surfaces, the water supply and the surroundings. It is the rule’s last provision and it closes the circle it opened: what happens outside the building and in its surroundings is part of the plant’s sanitary standard, not a separate matter.

These requirements are checked within the Health Licence process before OGPe and in the Department of Health’s inspections. The rule itself refers to the current Puerto Rico Plumbing Code for the plumbing’s design, installation and maintenance. And Rule 4.3.7 of the same chapter applies to these establishments the provisions of Title 21 Part 110 of the Code of Federal Regulations on good manufacturing, packing and storage practices.

• Neglecting the grass and the building’s immediate surroundings, which the rule treats as areas where insects and rodents proliferate.
• Leaving the parking or yards in conditions that turn them into sources of contamination for the areas where food is exposed.
• Doing nothing when the adjoining land is not under the operator’s control and is not adequately maintained.
• Setting up the production line without leaving clear space between equipment and walls for cleaning.
• Designing without separating the operations where contamination may occur, by location, time, separation, air flow or closed systems.
• Letting seepage or condensation from apparatus, ducts and pipes fall on the food or its contact surfaces.
• Using unprotected bulbs over exposed food, or leaving suspended glass that could break over it.
• Siting fans without considering that they can increase the potential for contaminating the food and the packaging materials.
• Installing doors that open onto areas where food is exposed to contamination by air, with no double doors or positive air flow.
• Providing hot water only at the main sink and not in every area the regulation requires it.
• Leaving the floor without adequate drainage in areas cleaned with abundant water.
• Allowing cross-connections or backflow risk between the potable water piping and that of used water.
• Operating without clear and legible hand-sanitising signs in the areas where employees handle food, packaging or surfaces.
• Using water control valves that recontaminate already washed and sanitised hands.
• Accumulating process waste and residues so they generate odours and attract pests.

These are the government pages this guide is based on.

• Oficina de Gerencia de Permisos (OGPe)

  OGPe

  docs.pr.gov

• Permit Management Office

  ogpe

  ogpe.pr.gov

• Department of Health

  salud

  www.salud.pr.gov