### Question
How is the term established record as an importer defined?


### Answer
The term **established record as an importer** is defined in *21 CFR § 1300.02* as the following:

> that the regulated person has imported a listed chemical at least once within the past six months, or twice within the past twelve months from a foreign supplier. 

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

