### Question
How is the term established business relationship with a foreign customer defined?


### Answer
The term **established business relationship with a foreign customer** is defined in *21 CFR § 1300.02* as the following:

> the regulated person has exported a listed chemical at least once within the past six months, or twice within the past twelve months to a foreign manufacturer, distributor, or end user of the chemical that has an established business in the foreign country with a fixed street address. 

#### Citation:
  - *21 CFR § 1300.02*
  - Heading: **Title 21-Food and Drugs > PART 1300—DEFINITIONS**

