Specialized Processes

Additional regulations apply when facilities are:

• Acid foods, acidified foods, or low-acid canned foods
• Bottling water
• Bottling juice
• Vacuum sealing foods

When a manufacturer uses these specialized processes, specific training needs to be completed, and/or specific documents need to be created. The section for each process provides information and steps for gaining approval before implementing it.

Acid Foods, Acidified Foods, and Low Acid Canning

Acidified foods require pH controls for Clostridium botulinum (botulism). It grows in hermetically sealed packages and produces a deadly neurotoxin. It causes paralysis and death.

• Acid foods have a pH of 4.6 or below before being processed
• Acidified foods are naturally low acid until processed with an acid or acidic food ingredient, they have a water activity greater than 0.85, and have a final equilibrium pH of 4.6 or below
• Low-acid canned foods have a final equilibrium pH greater than 4.6 and water activity greater than 0.85 in hermetically sealed containers.

Acidified and low acid foods must be validated by a Food Processing Authority to identify Critical Control Points (CCPs) that need to be monitored. The Food Processing Authority will provide a letter that gives instructions for controlling the CCPs. The letter will have to be included when filing your scheduled processes with the Food and Drug Administration (FDA). For more details on acid, acidified, and low acid foods, see our Guidelines for Food Processing Safety.

Steps to complete when making acidified or low-acid canned foods:

1. Complete Better Processing School. See the Resource page for several options. 
2. Complete Plan Review or abbreviated plan review processes through the Bureau of Environmental Services.
3. Process validation through a Food Processing Authority.
4. Register as a food facility.
5. Register as a food canning establishment.
6. File scheduled processes.
7. Low acid food manufacturers must include a processing authority's validation of their retort machine's heat transfer for each product, container type, and container size when filing scheduled processes.
8. Apply for a food processing permit.

Bottled Water

Manufacturers that bottle water have additional requirements explained in Title 21 of the Code of Federal Regulations (CFR). Title 21 CFR Part 129 covers processing bottled water, and Part 165.110 covers quality standards for bottled water.

Steps to complete when bottling water:

1. Obtain approval of the water source. Municipal water sources are verified by the local water authority. Water sourced from a spring, artesian well, or drilled well must be tested to verify these sources. Contact the Alabama Department of Environmental Management (ADEM) to certify the well water or spring water as a safe drinking water source. (334) 271-7700. ADEM will provide a letter to certify the source.
2. Finished product test results must be submitted to the Bureau of Environmental Services during the Plan Review process or before a food processing permit is issued.
3. Complete Plan Review or abbreviated plan review processes through the Bureau of Environmental Services.
4. Register as a food facility.
5. Apply for a food processing permit.

Fruit/Vegetable Juice Processing HACCP

Juice is 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. Fruit and vegetable juices contamination with E. coli, various Salmonella species, and Cryptosporidium parvum parasites has caused foodborne illness outbreaks. The risk of producing contaminated juices requires additional control measures to achieve a 5-log pathogen reduction.

Juice processors must adhere to the state regulations, 21 CFR 120, and 21 CFR 117 subparts A, B, and F. 21 CFR 117 subparts C and G are not applicable since 21 CFR 120 covers those areas for juice processors. As a part of these regulations, juice manufacturers are required to develop a Hazard Analysis Critical Control Point (HACCP) Plan.

A Hazard Analysis Critical Control Point (HACCP) plan identifying chemical, physical, and biological hazards must be developed by the manufacturing firm. This HACCP will set process controls or Critical Control Points (CCPs) that are key to eliminating and reducing risks to acceptable levels. The Association of Food & Drug Officials created Guidance for Developing HACCP Plans for Specialized Processes at Retail. This could help with developing a HACCP.

Steps to Complete when processing fruit or vegetable juice:

1. Attend and complete a juice HACCP training.
2. Develop a HACCP plan for each juice produced.
3. Process validation through a Food Processing Authority.
4. Complete Plan Review or abbreviated plan review processes through the Bureau of Environmental Services.
5. Register as a food facility.
6. Apply for a food processing permit.

Reduced Oxygen Packaging HACCP

Reduced oxygen packaging (ROP) or vacuum sealing is a process used to maintain food quality. The quality is maintained if it stays sealed inside the packaging. But this comes at a risk.

There are several microorganisms that could potentially contaminate ROP foods.

One of those microorganisms is Clostridium botulinum (botulism) since the oxygen is removed during packaging, creating an ideal environment for botulism to grow.

Due to the increased risk, there are additional requirements for manufacturers using ROP.

A Hazard Analysis Critical Control Points (HACCP) plan identifying chemical, physical, and biological hazards must be developed by the manufacturing firm. This HACCP will set process controls or Critical Control Points (CCPs) that are key to eliminating and reducing risks to acceptable levels. The Association of Food & Drug Officials created Guidance for Developing HACCP Plans for Specialized Processes at Retail. This could help with developing a HACCP.

Steps to complete when reducing oxygen packaging processed foods:

1. Create Standard Operating Procedures (SOPs) detailing the entire process in a step-by-step format.
2. Develop a HACCP plan for each product using ROP.
3. Complete Plan Review or abbreviated plan review processes through the Bureau of Environmental Services.
4. Register as a food facility.
5. Apply for a food processing permit.

Next: Certificate of Free Sale Application