Better Process Control

1. What is a food manufacturing/processing facility?
2. Who do I contact if I want to sell my dry mixes to a grocery store or other retail facility?
3. I run a grocery store and a local processor wants me to sell their processed foods; such as: honey, jams, jellies, breads, etc. Can I sell these items?
4. How do I certify my product at organic?
5.What are the requirements for bottling drinks (i.e. lemonade, water and soda) in Missouri?
6. Can I produce sprouts as a home-based business?
7. What is a better process control school?
8. When is a Better Process Control School certification required?
9. Who should attend the Better Process Control School?
10. Where can I find a Better Process Control School certification training schedule and location?
11. What is a scheduled process?
12. When is a scheduled process required?
13. Who qualifies as a "Process Authority"?
14. What does a process authority do?
15. Should each batch of product be tested for pH and water activity?
16. Can I sell my products that I make at home over the internet?

Labeling

1. What information is required on labels?
2. How are the major allergens supposed to be listed on the label?
3. Do I need to include nutritional information on my product?
4. If nutritional information is needed for my product(s) where can I get that analysis done?
5. If the product is marketed outside of Missouri, do the labeling requirements change as opposed to only selling in Missouri?
6. What is the difference between a sell by and use by date?
7. Do I need ingredients on my product label?
8. Do I have to put the "This product is made in a home kitchen not subject to inspection" on my product, or can I use a placard or sign?
9. What is required on the labels of meat products?

Better Process Control

1. What is a food manufacturing/processing facility?
A food processing facility is a commercial operation that manufactures, packages, labels or stores food for human consumption, and provides food for sale or distribution to other business entities such as food processing plants or food establishments.

2. Who do I contact if I want to sell my dry mixes to a grocery store or other retail facility?
Repackaging or mixing dry ingredients for sale to retail operations is under the jurisdiction of the DHSS Manufactured Food Program. This program can be contacted by calling 573-751-6095

3. I run a grocery store and a local processor wants me to sell their processed foods; such as: honey, jams, jellies, breads, etc. Can I sell these items?
Yes, if these items come from an inspected approved facility. The processor must show a recent inspection or if applicable a current permit/license to show that they meet the requirements of the regulations.

4. How do I certify my product as organic?
The Missouri Department of Agriculture has a program that can help people interested in marketing their products as organic. For more information contact: (573)-522-4170.

5. What are the requirements for bottling drinks (i.e. lemonade, water and soda) in Missouri?
Information on bottling beverages can be found on the industry page for manufactured foods on this website. Juices will be required to comply with Food and Drug Administration rules that requires verification of a Hazard Analysis Critical Control Point plan.

6. Can I produce sprouts as a home-based business?
No. Sprouted seeds have been determined to be the source of several foodborne illness outbreaks. For this reason sprouted seeds have been defined as a potentially hazardous /TCS- (time/temperature control for safety) food and would require a special process verification to be sold at retail. Sprouting seeds for sale to retail operations would require inspection by the DHSS Manufactured Food Program. Contact DHSS by calling 573-751-6095 to ask questions about these requirements.

7. What is a better process control school?
The Better Process Control Schools (BPCS) program was instituted to meet the requirements of FDA’s regulations in 21 CFR 108, 113, and 114. These programs are meant to assure low-acid or acidified food producers are taking the necessary steps to prevent public health problems historically connected to these foods. Low-acid canned pet foods are regulated by the same regulations. Thermally processed meat and poultry products must comply with similar regulations and training requirements (9 CFR 318.300 and 381.300) under the authority of the USDA. Contact DHSS at 573-751-6095 for more information.

8. When is a Better Process Control School certification required?

9. Who should attend the Better Process Control School?
The operators of processing systems, retorts, aseptic processing and packaging systems and product formulating systems (including systems wherein water activity is used in conjunction with thermal processing). Container closure inspectors shall be under the operating supervision of a person who has attended an approved school. A person trying to register a scheduled process with the FDA must show they have expert knowledge acquired through appropriate training and experience.

10. Where can I find a Better Process Control School certification training schedule and location?
The Grocery Manufacturers Association (GMA) Need LInk has a brochure that is updated annually that lists many of the programs provided by approved university programs. These programs have been approved by the FDA for acidified and low-acid foods. DHSS does not maintain a list of Better Process Control Schools.

11. What is a scheduled process?
When a commercial processor begins manufacturing, processing, or packing acidified or low-acid foods in any state the processor must register that process with the FDA. This process must have been reviewed and verified by a process authority before the process can be registered.

12. When is a scheduled process required?
Scheduled processes must be followed during manufacture of the food for which it was designed. A scheduled process requires critical factors be monitored under the operating supervision of a qualified individual. This person must have attended and successfully completed a Better Process Control School and must be certified to supervise those operations.

13. Who qualifies as a "Process Authority"?
A process authority is a qualified person who has expert knowledge acquired through appropriate training and experience in the thermal processing or acidification and processing of acidified foods. Most Better Process Control School locations also have people on staff who can act as process authorities.

14. What does a process authority do?
A process authority evaluates food processes to insure that the risks involved in production are minimized. The person acting as a process authority must have expert knowledge of ther¬mal processes, hermetically sealed containers, and food microbiology. The process authority must have facilities to determine a safe process or process schedule for each product.

15. Should each batch of product be tested for pH and water activity?
The frequency of testing would be dependent on factors such as the process being used, the kind of food being processed and other factors as determined by a process authority. Foods that are categorized as non-potentially hazardous by a pH and/or water activity test might not have to be tested again until the recipe or process is changed. Other foods such as acidified foods would require testing on every batch to insure that the acidification process is being done correctly or corrective action must be taken.

16. Can I sell my products that I make at home over the internet?
No, internet sales of foods require the food be made in an approved kitchen.

Labeling

1. What information is required on labels?
Basic information that is required on food labels includes but is not limited to the common name of the food, a list of ingredients (listed by weight), the amount of food in the package (net. wt. in English and metric), and the name and address of the processor/distributor.

2. How are the major allergens supposed to be listed on the label?
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires food manufacturers to label food products that are made with an ingredient that is a major food allergen in one of the following two ways shown in the diagram below:

allergen label

3. Do I need to include nutritional information on my product?
Yes, unless the business can request an exemption their labels are to carry nutrition facts on the label. Small businesses may request an exemption for nutritional labeling requirements from the FDA otherwise food labels should have that information.

4. If nutritional information is needed for my product(s) where can I get that analysis done?
There are private laboratories and universities that provide this service for a fee. Additional guidance on nutritional labeling requirements can be found at the FDA’s web site. DHSS does not keep a list of laboratories or universities that will do the analysis.

5. If the product is marketed outside of Missouri, do the labeling requirements change as opposed to only selling in Missouri?
No, since DHSS has adopted the FDA’s labeling standards from the Code of Federal Regulations, foods must be labeled the same no matter where they are sold.

6. What is the difference between a sell by and use by date?
Both of these terms are used by companies to indicate the recommended shelf life of the product. Neither is required by law to be on a food package so DHSS does not regulate these dates. These are used for guiding consumers on use during peak quality for the product.

7. Do I need ingredients on my product label?
Yes, food product labels require an ingredients listing.  The Missouri Food Code section 3-602.11, requires that foods sold directly to the end consumer in a packaged form be labeled. The label requirements include “If made from two (2) or more ingredients, a list of ingredients in descending order of predominance by weight, including a declaration of artificial color or flavor and chemical preservatives, if contained in the food.” This allows the consumer to make an informed decision about whether they can safely eat a food if they have allergies.

8. Do I have to put the "This product is made in a home kitchen not subject to inspection" on my product, or can I use a placard or sign?
There is an exemption in the food code, in section 3(h)(iv) of the definition of a food establishment that covers requirements for foods that are produced in facilities that are not considered food establishments. For these exempt products made in home kitchens; when the products are sold packaged they must have the statement on the package label, if the food is being sold by the piece then there must be a placard at the point of sale informing the consumer.

9. What is required on the labels of meat products?
The requirements for labels on meat and poultry products are found in the "A GUIDE TO FEDERAL FOOD LABELING REQUIREMENTS FOR MEAT, POULTRY, AND EGG PRODUCTS". Meat and poultry cut in a custom-exempt facility must be labeled “not for retail sale”. Any meat processing done under a special process agreement in a retail meat market must follow the labeling requirements listed in the Missouri Food Code sections 3-502.11 or 3-502.12 and 3-602.11, in accordance with the plan submitted to the appropriate health department.