Food Rules and Regulations
As a result of The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and supported by the Food Safety Modernization Act, any owner, operator, or agent in charge of a domestic or foreign facility that manufactures/processes, packs, or holds food for human or animal consumption in the U.S., or an individual authorized by one of them, must register that facility with FDA. The purpose of this mandate is to more readily identify foods in the event of an intentional attack on the United States food source. Even if the foods do not enter interstate commerce, all facilities must be registered. There is no cost associated, and registration can be done online, by fax, or through the mail.
There are a number of facilities that do not have to register. These facilities are:
- A foreign facility, if food from such facility undergoes further manufacturing/processing (including packaging) by another facility outside the U.S.
- Farms, which are establishments devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting.
- Retail food establishments, which are establishments that sell food directly to consumers as their primary function.
- If an establishment's annual sales to consumers exceed its sales to non-consumers, the establishment is an exempt retail establishment.
- In respect to the definition of a retail food establishment, the Food Safety Modernization Act amended the definition of a retail establishment to include the sale of food at a roadside stand or farmers market, sale and distribution through a community supported agriculture commodity, or any other direct sales endeavor of this nature.
- Restaurants, which are establishments that prepare and serve food directly to consumers for immediate consumption.
- Nonprofit food establishments, which are charitable entities that prepare or serve food directly to consumers, or otherwise provide food for consumption by humans or animals in the U.S.
- Fishing vessels, including those that not only harvest and transport fish but also engage in practices such as heading, eviscerating, or freezing intended solely to prepare fish for holding on board a harvest vessel. Fishing vessels that otherwise engage in processing fish are required to register.
- Facilities that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.)
Information on how to register can be found on the FDA webpage about the registration of food facilities.
If you wish to register your facility online, you may do so at the FDA's online registration page.
Registration for Acidified and Low-Acid Foods
If you are producing an acidified or low acid canned food, you must register your facility and your scheduled process with the FDA as well. This is in addition to registering your facility as part of the Bioterrorism Act.
Your facility must be registered using FDA form 2541. Instructions for filling out form 2541 are listed on the FDA website.
A PDF of form 2541 can be found here:
In addition to registration of your facility, you must also fill out a scheduled process and submit your information to the FDA using form 2541A. This form can be found here: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076784.pdf.
There are some basic regulations that are required for all food processing facilities to follow. These regulations are current Good Manufacturing Practices (GMP’s) and/or Sanitation Standard Operation Procedures (SSOP's).
GMP's are regulations established to ensure that every aspect of a new product (including formulation, processing, packaging, labeling, and distribution) meets the standards to deliver the safest and best quality product to the consumer. GMP's are defined by the Code of Federal Regulations (21 CFR 110), entitled Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food, and are fundamental to food safety. The topics of focus in 21 CFR 110 include personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, warehousing and distribution, and natural or unavoidable defects. GMP’s are a regulatory requirement for all foods except for poultry and meat products.
Sanitation regulations for meat and poultry require that the food produced is wholesome and produced under sanitary conditions which are included in specific Sanitation Standard Operating Procedures (SSOPs). The USDA developed SSOP's as a regulatory basis for written procedures for sanitation activities. Detailed information regarding SSOP's can be found at http://www.fsis.usda.gov/PDF/SSOP_module.pdf.
There are also specific regulations for canned foods. Those regulations can be found in the Code of Federal Regulations as indicated:
- Low Acid Canned Foods
- 21 CFR Part 113
- Acidified Canned Foods
- 21 CFR Part 114
- Emergency Permit Control
- 21 CFR Part 108.25
- Meat and Poultry
- 9 CFR Parts 300-592
Producers of jams, jellies, and preserves must be sure that their product meets the standards of identity established for their products. The standards of identity and regulations for jams, jellies, preserves, fruit butters, and related products can be found in 21 CFR 150, found here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=150.160
Acidified foods are considered risky, because a product that is not produced correctly may cause serious illness to those who consume it. For this reason, acidified foods have their own specific regulations as outlined by the Code of Federal Regulations (21 CFR 114 and 21 CFR 108.25 for FDA regulated products). In Virginia, producers of acidified foods are required to follow the regulations specified by the FDA for acidified foods, regardless of whether or not the products enter into interstate commerce.
What is an acidified food?
Acidified foods are low-acid foods to which acids or acid foods have been added to reduce the pH to 4.6 or less, and which have a water activity of greater than 0.85. In acidified foods, the addition of low-acid ingredients significantly alters the pH of the acid food ingredients in the product. The acidified food regulations apply to shelf-stable foods that are sold without refrigeration in sealed containers. These shelf stable products require a heat-treatment and proper acidification to be safe for consumption.
Many acidified foods are referred to as “pickled”. These are low acid foods that have been canned with an acid (like vinegar or lemon juice) to reduce the pH to 4.6 or lower. Examples include pickled eggs, meats, and vegetables. Other acidified foods might include black bean and corn salsa or some sauces.
If a food product contains only naturally acidic foods, it will not be considered an acidified food. However, if your food product contains both low acid food ingredients and acid food ingredients, your food will need to be tested to determine if it is classified as an acidified food. Any food that contains an acidified food as an ingredient is classified as an acidified food.
If your product is classified as an acidified food, you will need to be aware of a number of requirements before you can legally sell your product:
- You must be certified or supervised by someone who is certified in processing of acidified foods. You may do this by taking the Better Process Controls School or a similar course approved by the FDA.
- You must adhere to current Good Manufacturing Practices as outlined in 21 CFR 110.
- The equilibrium pH of your food is required to be 4.6 or lower.
- Your food product will require a heat treatment during processing sufficient to destroy any microorganisms of public health concern, and to destroy those microorganisms that are not of public health concern but are capable of reproducing in food.
- You must contact an acidified foods processing authority to develop a scheduled process for your specific product.
- You will be required to adhere to your scheduled process, confirmed by documentation.
- You will need to measure and record the pH of the finished product for each batch of product you make. Depending on the expected final pH of your product, you will have to measure pH using a pH meter (rather than pH test strips).
- You will be required to test and record the integrity of the final container in which your product is packaged with sufficient frequency to ensure that the container suitably protects the food from leakage or contamination.
- All primary product containers must be labeled with a unique identifying code visible to the naked eye.
- You must file your business and your scheduled process with the FDA using form 2541 and 2541a, respectively.
- You must keep records. These include records of examinations of raw materials, packaging materials, and finished product; records verifying that you have met all critical control points outlined in your scheduled process; and records identifying initial distribution of the product. These records must be kept for three years.
- If you deviate from your scheduled process, you must keep records addressing the deviation and how it was rectified. These records must be kept in separate files from your other processing records, and must be kept for three years.
- You must have an established recall plan.
- You must contact VDACS to inspect your kitchen and process. You may not sell your product until you have VDACS approval.
Note: This document should be regarded strictly as a supplement to the Acidified Foods Regulations, and should never be regarded as a substitute to reading and understanding the regulations. For a complete list of requirements, please consult 21 CFR Part 114 and 21 CFR Part 108.25
All foods are not created equal. Some are naturally high in acid, some are only slightly acidic. Some foods contain an abundance of free moisture, while others are very dry. These characteristics contribute not only to the way a food looks, feels and tastes, but also to the ability of microorganisms to survive and grow. As a food entrepreneur, you should be aware of how ingredients in your product make the food look, feel, and taste; as well as how the ingredients create environments for microorganisms like bacteria, yeast, and molds to survive and grow.
In canned foods, the most important safety concern is the ability of a bacterium known as Clostridium botulinum to grow within the food product. Under certain conditions, Clostridium botulinum can survive and grow inside of a sealed container of food and produce a deadly toxin. If the toxin is ingested, the consumer may suffer from botulism which can be fatal. The food processor can avoid this devastating scenario by understanding the properties of the food products they are canning and following a process developed specifically for their food product by an expert in the field. The first step in insuring safe food is to understand how it should be classified.
f you plan on making and selling canned foods, it is important to know the amount of acid that is present in the food (pH) and the amount of moisture available to microorganisms (aw). These parameters will determine how the food product should be classified, and the classification of the food is what determines how it will be regulated. The food will be classified depending on the pH value of the food relative to the pH value 4.6, and the aw being equal to or less than 0.85. The three classifications are acid foods, acidified foods, and low-acid foods.
Acid foods are those that have a natural pH of 4.6 or below. Most (but not all) fruits are considered acid foods. Acid foods are exempt from the Acidified Foods (21 CFR 114) and Thermally Processed Low-acid Foods Packaged in Hermetically Sealed Containers (21 CFR 113) regulations, but processors must still comply with Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR 110) regulations.
Acidified foods are low-acid foods that have had acid(s) or acid foods added to them. The finished equilibrium pH of these food products must be 4.6 or below, and the aw greater than 0.85. Commonly acidified foods include beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, and tropical fruits, and these products are often called “pickles” or “pickled”. Acidified foods must follow regulations outlined in 21 CFR 110 “Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food”, 21 CFR 114 “Acidified Foods”, and 21 CFR 108.25 “Emergency Permit Control”.
Low-acid foods are those that have a pH of greater than 4.6, meaning that they contain low amounts of acid. In order to be classified as a low-acid food, the aw must be greater than 0.85. Examples of low-acid foods include meats, most vegetables, most starch based foods, and most protein-heavy foods. Canning low-acid food creates the dangerous environment necessary for the growth of Clostridium botulinum. Therefore the regulations for processing and selling low-acid canned foods are more extensive than for the other food categories. Low-acid canned foods are regulated by 21 CFR 110 “Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food”, and 21 CFR 113 “Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers”. Processors of low-acid canned foods must have a great deal of knowledge of thermal processing, microbiology, and how to deal with process deviations. Because A) the risk for processing and selling low-acid canned foods is high, B) cost associations for equipment needed for safely processing low-acid canned foods are high, and C) knowledge of complex processing protocols is great, it is not recommended that small food businesses and start-up food entrepreneurs engage in the processing and selling of low-acid canned foods. Home-based processing of low-acid canned foods for retail sale is prohibited.
Water activity may be a critical factor in determining the classification of the food product. The amount of moisture in the product is not the same as water activity. Water activity is the amount of free moisture in a product, meaning the water in the product that is not bound to salt, sugar, protein, or other elements in the food. For example, water has an aw of 1.0 (the highest on the scale), but soy sauce has an aw of 0.80. Although soy sauce is a liquid and contains a high amount of moisture, the water activity is much lower than water. This is because soy sauce is very salty, and the salt acts to bind a large amount of the water in the product, reducing the amount of free moisture available for microorganisms to use for growth and survival. When the aw of a product is 0.85 or lower, the water activity is considered low enough to control the growth of potentially harmful microorganisms. Therefore, food products with an aw of 0.85 or less are exempt from 21 CFR parts 108, 113, and 114 regardless of their pH.
There are a number of foods that are specifically named excluded from acidified food regulations. These categories include:
Acid foods - Foods with a natural pH of 4.6 or less, even if acid is added during processing.
Foods that are formulated with predominately acid ingredients, but contain small amounts of low-acid foods - The addition of the low-acid ingredients cannot significantly change the pH of the overall product from that of the predominant acid food. Many sauces and condiments fall under this category.
Fermented foods - Foods (including some cucumber pickles, most green olives, and sauerkraut) whose pH is reduced not by the addition of acids or acid foods, but by by-products of a bacterial fermentation process.
Jams, Jellies, Preserves - Products excluded from these regulations are only those covered by the standard of identity (21 CFR 150). Products are only exempt if they are made from acid-ingredients. Jellies made from low-acid ingredients such as pepper jelly need to be tested, and may be considered an acidified food.
Refrigerated foods - Products which are stored, distributed and retailed under refrigeration are exempt from acidified food regulations.
Water Activity 0.85 or less - Any food, which always has a water activity of 0.85, or less is excluded from coverage under these regulations.
Keeping records is a required aspect of producing acidified foods, and a good practice for producers of all foods. Keeping records allows for food processors to document their processes and easily use the information to confirm processing consistency as well as compliance. Keeping records is the only way to prove that specific actions were performed adequately during food processing. There is a common saying that if you didn’t keep records, it didn’t happen. To clarify, to prove to an inspector that you have been following regulations (like following a scheduled process), you must show them the records you have kept. If you do not have records to prove your action(s), there is no proof that the actions were performed.
Records required by FDA for acidified foods:
Specifics for records required by FDA can be found in the Code of Federal Regulation, Title 21 Part 114 (Acidified Foods) or in chapter 6 of Canned Foods – Principles of Thermal Process Control, Acidification and Container Closure Evaluation (the Better Process Control School textbook).
For your establishment, you need the following records:
- Food Canning Establishment Registration (FDA Form 2541)
For each product processed:
- Food Process Filing for All Methods Except Low Acid Aseptic (FDA 2541a)
- Formulation of each food product in standard units of measurement
- Flow chart for thermal processing
- A copy of a letter from your process authority
The following records specific for each product must be kept on file for three (3) years:
- Records of thermal processing
- Processing Temperature
- Processing Time
- Fill Temperature
- Records of container closure
- pH Measurements
- Specific to batches
- Deviations in processing
- Any deviation from your scheduled process must be written down in a separate log or file.
- Other critical factors as denoted by your process authority.
In addition, FDA regulations stipulate the following:
- Information concerning processes and procedures that determine whether commercial sterility has been achieved.
- Any instance of spoilage or process deviation that indicates a potential health significance of any lot of food that in whole or in part has entered distribution shall be promptly reported to FDA.
- All process deviations involving failure to satisfy the minimum requirements of the scheduled process shall be documented. These records shall be kept in a SEPARATE FILE or log identifying the appropriate processing records, corrective actions taken, evaluation procedures and disposition of the lot in question.
- Records of raw materials, packaging materials, finished and acidified products and of supplier’s guarantees or certifications that verify compliance with FDA regulations and guidelines.
- A code shall be embossed or printed on every container. The code must identify:
- The establishment where packed
- The product contained within
- Year, Day and Period packed.
- FDA requires the processor to maintain records that identify the initial distribution of the finished product.
- Processors shall register their processing facility with FDA.
- Processors shall register a scheduled process for each food in each container size with the FDA.
Container coding creates a way to track food and isolate affected products in the event of an incident needing a product recall. The container code contains information about the product that makes it easily identifiable to the manufacturer. Each code serves to link the container with a specific time frame in which the product was processed and packaged. If you package your product in a hermetically sealed container, you MUST include container coding on each of your containers. Processors of acidified foods must follow regulations for container coding as listed in CFR 114.
For each container that needs coding, the code must be marked on the containers so that it is permanently visible to the naked eye. Codes can be imprinted or embossed directly on the container. If that is not a possibility, codes may be legibly perforated or otherwise marked on the label, so long as the label is securely affixed to the product container.
The code should be developed so the following can be identified:
- The establishment where the product was packaged
- The product contained therein
- The year, day, and period during which it was packed
The code for the packing period should be changed with enough frequency to enable easy identification of lots during sale or distribution. Codes may be changed periodically on one of the following bases: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers constituting the batch do not represent those processed during more than one personnel shift.
For USDA regulated products, codes must be able to identify:
- The product (unless the product name is lithographed or printed directly on the container)
- The day and year packed
There are a variety of ways to code your product in order to identify the information required. One popular method is called the Julian Date Coding system. For example, the Julian Date Coding system was used to generate the product code 198G1115, where:
- 198 stands for the day of the year (1-365)
- G stands for the month of the year (A-L)
- 11 stands for the year packed (2011)
- 1 stands for the production facility (if more than one facility)
- 5 stands for the hour it was made or the batch number
A scheduled process is an important component of your food production, especially if you are producing acidified food items. Each acidified food item that you make must have a scheduled process that has been compiled with the assistance of a process authority, and the scheduled process shall be followed each and every time you have a production run. It is illegal to sell a canned acidified food product without obtaining a scheduled process and filing with the FDA before sell.
What exactly is a scheduled process?
A scheduled process is a detailed procedure developed for a specific product which includes information about product ingredients and formulation, processing specifics (times, temperatures, process flow), critical control points (pH, water activity, etc.), primary packaging, storage, and/or distribution. All specifics of the scheduled process must be met each time a batch of product is made, and the processor is responsible for documenting their actions to prove they adhered to their scheduled process. A scheduled process must be developed by a process authority that has expert knowledge in the processing of the particular food item in question.
According to the FDA, a scheduled process means: the process selected by a processor as adequate for use under the conditions of manufacture for a food in achieving and maintaining a food that will not permit the growth of microorganisms having public health significance. It includes control of pH and other critical factors equivalent to the process established by a competent processing authority.
What is the purpose of a scheduled process?
Scheduled processes are necessary in order to establish a method of food production that has been scientifically verified to produce safe food. If you are making a canned, acidified food product, there is potential that you could create an environment that is favorable for the growth of the pathogenic organism Clostridium botulinum. Clostridium botulinum is the microorganism that causes the disease botulism. Botulism can be deadly, but it is preventable through proper acidification and heat processing of food. In order to be sure that all canned foods that have the potential to support the growth of Clostridium botulinum are produced safely, a scheduled process is necessary and must be followed each and every time the food is produced.
What is a process authority and where can I find one?
A food processing authority for acidified foods is a person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods. This person understands the details of food safety as it applies to an acidified food product, and can give you specific requirements for processing your food in a safe manner. Many land-grant universities offer services to food processors in the states they serve to do food testing and provide scheduled process letters. A fee is generally charged for these services. There are also a number of private labs across the country who are qualified acidified food process authorities.
What do I do once a scheduled process has been developed for my product?
Once you have a scheduled process for your food products, there are a number of things you need to do in order to begin selling your item. First of all, if you are making an acidified canned food, you will need to register your facility with the FDA (form 2541) in addition to filing your scheduled process for each food you are planning on selling using FDA form 2541a. Acidified food processors are required by the FDA to take a Better Process Controls School course. You will also need to contact the Virginia Department of Agriculture and Consumer Services to get your process inspected. With VDACS approval, you will be permitted to sell your food products.
What do I have to do now that I have filed my scheduled process?
A scheduled process is not a free ride to make food for sale with no reservation. There are things you must keep in mind when making your food. Your scheduled process dictates the important critical control points that must be met each and every time you make a batch of food. If you do not meet the critical control points as listed in your scheduled process, then your food is considered adulterated and not legal for sale. In order to prove that you have met the critical control points necessary for your food products to be safe, you have to keep records. Keeping records of your critical controls points each time you process food is a requirement. Any time you deviated from your scheduled process, you must note the deviation that occurred and what you did to correct that action. You must maintain these records in a separate file and you must keep these records for three years before you may discard them.