Manufactured Foods
What is a Food Processor?
A food processor regulated by the Missouri Department of Health and Senior Services (DHSS) Manufactured Food Program is any entity that manufactures, processes, packs, or holds food for human consumption, and does not provide the food directly to the consumer.
Examples include but are not limited to:
Food warehouses, bakeries, breweries, seafood processors*, water bottlers*, canneries*, food ingredient manufacturers, flour mills, juice processors*, sprout growers*, frozen dessert processors*, beverage bottlers, distilleries, coffee roasters, spice blenders, snack food manufacturers, sauce and salad dressing manufacturers*, candy manufacturers, ice manufacturers, food grade gas manufacturers, and many others.
*See also the section labeled, “Specialized Products”, below.
Foods and food facilities that are not routinely regulated by DHSS include:
- Meat and egg products that are regulated by the United States Department of Agriculture or by the Missouri Department of Agriculture.
- Grade-A Milk and milk products that are regulated by the Missouri Milk Board.
- Food that is sold directly to the consumer in retail food establishments that are subject to the requirements of the Missouri Food Code and/or a local retail food code.
- Farms and the handling of raw agricultural commodities on farms.
- Manufacturers of dietary supplements, drugs, and medical devices.
Is my business a food processing business?
- Does the business produce any product (except those listed above that are not regulated by DHSS) that is likely to be consumed by humans, or to be used as an ingredient in an item that is likely to be consumed by humans?
and
- Does the business distribute any of those items to a business that will sell the product again, serve it to customers, or use it in a product that will be sold or served to customers (wholesale sales)?
If the answer to both of these is yes, your business is a food processor that may be regulated by the DHSS Manufactured Food Program.
Safe Food Processing Regulations
Food processors in Missouri must adhere to Federal and State of Missouri requirements for processing safe food.
Federal law requires that all food processors be in compliance with the Food, Drug and Cosmetic Act (FD&C Act), which outlines good manufacturing practices standards, as well as labeling and registration requirements.
Food processors must also be aware of any food safety risks associated with their product(s) and have appropriate controls in place to manage those risks.
All food processors must comply with the Food Safety Modernization Act (FSMA,) which addresses risk-based food safety programs. Information about FSMA can be found online.
This FDA brochure includes information about the following topics:
- Preventive Controls for Human Food.
- Sanitary Transportation of Human and Animal Food.
- Mitigation Strategies to Protect Food Against Intentional Adulteration.
- Foreign Supplier Verification Programs
- FDA Food Facility Registration and Qualified Facility Attestation
- Reportable Food Registry
Good Manufacturing Practices and Food Safety Plans
All foods must be processed in accordance with the Code of Federal Regulations, 21 CFR 117. This code outlines the requirements for current Good Manufacturing Practices (GMPs), training of supervisors and food handlers, development of a food safety plan, control of food allergens, development of a recall plan, and required records of food processing.
Missouri has adopted 21 CFR 117 by reference, so that there is no difference between Federal and State requirements for operating a food processing facility.
Inspections
Inspections of food processors are conducted by the Missouri Department of Health and Senior Services (DHSS) and/or by the United States Food and Drug Administration (FDA).
Routine inspections of processing facilities are conducted by DHSS approximately once per year. Routine inspections of warehouses are conducted an average of once every three years.
The State of Missouri does not license/permit food processors and there is no fee for routine inspections.
Processing Facility Construction
While DHSS does not conduct formal plan reviews, processors may contact our central office to request a review of plan designs prior to construction.
Plans that undergo this informal review are not considered to be “approved,” but our agency is happy to assist in identifying ways in which the facility described in the plan would not be in compliance with GMPs.
This is not intended to be a complete list of requirements, but the following are some general expectations for a food processing facility:
- Appropriate wastewater disposal system (e.g. lagoon, functional subsurface system that does not discharge wastewater, public sewer).
- Safe water supply (e.g. public water or a well that meets requirements with water that tests negative for coliform and e. coli)
- Dedicated handwashing sink(s) in the production room; hot/cold running water, proper wastewater disposal, soap, disposable towels and a trash can nearby.
- Adequate method to clean and sanitize equipment and utensils. Usually this is a three-compartment sink.
- Floors, walls, and ceilings are clean and in good repair, non-absorbent surfaces.
- Proper food contact equipment utensils that are clean and in good repair.
Specialized Products
Some foods carry inherent risk of foodborne illness, and have additional applicable regulations designed to mitigate that risk.
These products include acidified foods (like pickles, salsa, bottled tea, and other shelf-stable foods preserved with acids), bottled water, juice, seafood, raw sprouts, frozen desserts, and low-acid canned foods (like canned corn, sweet potatoes, beans, etc.)
Contact the Manufactured Food Program for more information about the additional regulations and requirements for processing these products prior to beginning operation.
FDA Food Facility Registration
Most food processors must register with FDA under the requirements of the 2002 Bioterrorism Act prior to beginning processing food. The Food Safety Modernization Act (FSMA) requires that this registration be updated every two years. Registration is free and is done online.
There are some types of food businesses that are exempt from registration which are outlined in this guidance document. Be aware that in most situations a food business that is exempt from registration will still need to be inspected by DHSS.
Contacts
Contact DHSS with any questions about opening or operating a food processing business in Missouri:
Bureau of Environmental Health Services
Section for Environmental Public Health
Missouri Department of Health and Senior Services
PO Box 570
Jefferson City, MO 65102-0570
Phone: 573-751-6095 or (toll-free) 866-628-9891
Fax: 573-526-7377
Email: DHSSFOODSAFETY@HEALTH.MO.GOV