| On
the Part B form, applicants are asked to identify their supplier
or suppliers. If a licensee changes suppliers, how does the licensee
report the change to API?
The licensee should consider this a revision of the licensed product
and submit a new Part B (no other form is necessary unless other
changes to the license need to be reported).
When are licensees required to pay the volume-of-sale
royalty?
Licensees pay the volume-of-sale royalty after the first year of
licensing. Reporting the amount of licensed diesel exhaust fluid
sold is a requirement for license renewal.
How long does API expect licensees to store
retain samples from diesel exhaust fluid batches?
API defers to paragraph 5.2 of ISO 22241 Part 3, which states that
“samples should be kept safe for at least the shelf life of
the volume of AUS 32.” Part 3 explains shelf life in paragraph
4.2.2.
Will API’s audit system take into account
repeatability and reproducibility of the tests prescribed by ISO
22241?
Yes, API’s analysis of diesel exhaust fluids sampled in the
marketplace will take into consideration the repeatability and reproducibility
limits included in ISO 22241 Part 2.
What is a DEF license?
When an applicant has completed all of the steps necessary to become
licensed, API will issue a document signifying that the applicant
is licensed to display or use the API Diesel Exhaust Fluid Certification
Mark in conjunction with its licensed diesel exhaust fluid. This
document would be valid for one year and would be considered part
of the Part C Diesel Exhaust Fluid licensing agreement.
When a licensee is asked to report volume
of sale, is API asking for volume of licensed diesel exhaust fluid
sold or volume manufactured?
API is asking for volume of licensed diesel exhaust fluid sold.
Will the licensing fee structure be reviewed
periodically and if yes, how often?
Yes, API will review the licensing fee structure annually. If changes
are necessary, they will be implemented only once per year.
What is an acceptable “Certificate of
Analysis” that is supposed to accompany Part B of the application
and how often should one be submitted?
A quality certificate as described in paragraph 5.5.1 of ISO 22241
Part 3 that shows test results for all tests required by ISO 22241
Part 1 would be sufficient. A new quality certificate would be required
if the licensee switches suppliers or modifies its licensed product.
Separate certificates would not be required if licensed fluid is
manufactured at more than one site.
If a licensee has three sites that produce
licensed product and a product from one of the sites fails API’s
audit, how does this affect the company’s license?
A failing product discovered during an API audit does not automatically
result in license suspension or revocation. The severity of the
failure and the licensee’s response to the issue play a role
in the status of the license.
Can a licensee add new trace codes for licensed
products?
Yes, a licensee can always add trace codes to the ones on file with
API. |