FDA Reader
A Food Industry Guide to the FDA

Blog

A Food Producer's Guide to FSMA and FDA Regulation
Posts in Definition
Interstate Commerce and FDA Jurisdiction
Interstate commerce refers to products that cross state lines prior to consumption, or products composed of ingredients that have crossed state lines.

Interstate commerce refers to products that cross state lines prior to consumption, or products composed of ingredients that have crossed state lines.

What is Interstate Commerce?

If a product crosses state lines between the start of the manufacturing process and when it is received by the individual who purchases it, then it has entered "interstate commerce".

Additionally, if the product is composed of ingredients from out-of-state, then it is considered to be a part of "interstate commerce" -- even if the product was created and consumed in state.

The technical definition of interstate commerce is:

"(1) commerce between any State or Territory and any place outside thereof,

and

(2) commerce within the District of Columbia or within any other Territory not organized with a legislative body."

FD&C Act [21 U.S.C. 321(b)] 

Examples of food that enters interstate commerce:

  • A frozen pizza business that has a website and ships to buyers nationwide.

  • A food processing facility that operates in New York and supplies cookies to bakeries in New Jersey.

  • A distributor that holds food products created by local food producers in a warehouse and distributes them to a local retailer who, in turn, sells them in several states

 

How Does Interstate Commerce  Relate to the FDA?

Whether a product enters interstate commerce is a major factor in determining whether a food business falls under FDA Jurisdiction. The other major factor is what type of food business it is. 

However, it is worth noting that all domestic facilities that engage in food processing, production, packing, or holding, must register as a Food Facility.

Additionally, the FDA may regulate any product that is adulterated or misbranded, even if that product doesn't enter interstate commerce.


Understanding E. Coli in a Food Processing Context

What is E. Coli?

The Escherichia Coli bacteria shown under a microscope

The Escherichia Coli bacteria shown under a microscope

We all know that E. coli is a threat to human health that is transmitted by food. But what foods specifically? How is it controlled and how can we protect ourselves from it as eaters and food producers?

The Basics:

Escherichia coli is a bacteria that produces a toxin called “Shiga”, that can cause food borne illness and even death.

Associated Foods:

  • Raw ground beef

  • Raw seed sprouts

  • Raw milk

  • Unpasteurized juice

  • Foods contaminated by fecal matter

Transmission: 

Human-to-Human or via contaminated food.

Incubation Period: 

Usually 3-4 days after exposure, but it can range from 1-9 days.

Symptoms:

  • None (it can be asymptomatic)

  • Diarrhea

  • Bloody Diarrhea

  • Kidney failure

Control Measures (i.e. how we stop it)

  • Cooking food to 155º for 15 seconds will kill E. coli.

  • No bare hand contact with ready-to-eat (RTE) foods

  • Strong employee health policies (i.e. no sick employees handling food)

  • Hand washing

  • Prevention of cross-contamination

  • Pasteurization or treatment of juice

The Bottom Line:

E Coli is a dangerous bacteria that can be transmitted via food and cause tremendous harm. At the same time, it’s something we can control quite easily and, if you are taking appropriate precautions, should not be something to worry about.

If you have more questions about how to control E. coli, ask in the comments section below.