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| 1/ Who must register? | ||||||||||||||||||||||
The owner, operator, or agent in charge of a domestic
or foreign facility that manufactures/processes, packs, or holds food
for human or animal consumption in the U.S., or an individual authorized
by one of them, must register that facility with FDA by December 12, 2003. |
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| 2/ What is the deadline for registration? | ||||||||||||||||||||||
The owner, operator, or agent in charge of a facility
that manufactures/processes, packs or holds food for consumption in the
U.S. must register the facility no later than December 12, 2003. |
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Facilities that begin to manufacture/process, pack,
or hold food for consumption in the U.S. on or after December 12, 2003,
must register before they begin such activities. |
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| 3/ When must prior notice be submitted? | ||||||||||||||||||||||
Prior notice must be received and confirmed electronically
by FDA no more than 5 days before arrival and, as specified by the mode
of transportation below, no fewer than: |
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| 4/ What food is subject to the requirement for submitting prior notice? | ||||||||||||||||||||||
Prior notice applies to food for humans and other
animals that is imported or offered for import into the United States.
For purposes of the interim final rule, "food" is defined by
reference to section 201(f) of the Federal Food, Drug, and Cosmetic Act.
Section 201(f) defines "food" as articles used for food or drink
for man or other animals, chewing gum, and articles used for components
of any such articles. |
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| Examples of "food" include: | ||||||||||||||||||||||
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| 5/ What happens if a facility does not register? | ||||||||||||||||||||||
Failure of a domestic or foreign facility to register,
update required elements, or cancel its registration in accordance with
this regulation is a prohibited act under the Federal Food, Drug, and
Cosmetic Act. The Federal government can bring a civil action to ask a
Federal court to enjoin persons who commit a prohibited act, or it can
bring a criminal action in Federal court to prosecute persons who are
responsible for the commission of a prohibited act. If a foreign facility
is required to register but fails to do so, food from that foreign facility
that is offered for import into the U.S. is subject to being held within
the port of entry for the article unless otherwise directed by FDA or
the Bureau of Customs and Border Protection (CBP). FDA plans to issue
enforcement guidance regarding the agency's policies regarding refusals
of imported food under section 801(m)(1) or holds of imported food under
section 801(l). This guidance document will be available to the public,
and FDA will publish a notice of its availability in the Federal Register. |
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| 6/ If enterprise needs the support of FDA Services, please contact G.O.L CO., LTD | ||||||||||||||||||||||
For further information contact us : G.O.L CO., LTD. |