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| The Evolution of FDA’s Proposed
‘Prior Notice’ Rules |
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| December, 2001 |
| In the wake of the September 11,
2001 terrorist attacks, Congress approves H.R. 3448, The Public
Health Security and Bioterrorism Preparedness and Response Act
of 2002 (The Bioterrorism Act of 2002), to “improve the
ability of the United States to prevent, prepare for, and respond
to bioterrorism and other public health emergencies. |
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| June 12, 2002 |
| President Bush signs The Bioterrorism Act
of 2002 into law.
Read
the complete Bioterrorism Act
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| July 17, 2002 |
| The FDA issues a “Stakeholder
letter” outlining the regulatory changes they intend
to make under the Bioterrorism Act mandate. |
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| February 3, 2003 |
| The FDA publishes its first proposals for Facility
Registration and Prior
Notice in the Federal Register and opens an initial comment
period. |
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| May 6, 2003 |
| The FDA announces two additional proposed
rules for imported food products.
The proposed Recordkeeping
Regulation mandates that all “domestic persons that
manufacture, process, pack, transport, distribute, receive,
hold or import food intended for human or animal consumption
in the U. S. and foreign facilities that manufacture, process,
pack or hold food intended for human or animal consumption
in the U.S” must keep detailed records on the foods
they produce or import into the U.S.
The proposed Administrative
Detention Regulation extends FDA’s authority to
detain imported foods that are determined to present “a
threat of serious adverse health consequences or death to
humans or animals.”
Final Rules have not been issued on Recordkeeping or Administrative
Detention as of December 19, 2003. |
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| October 10, 2003 |
| The FDA releases its Interim
Final Rules on Facility Registration and Prior Notice, with
significant changes to the timing requirements for Prior Notice.
The information required for Prior Notice is cut in half, though
the registration number requirement remains. |
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| October 16, 2003 |
| The FDA Food
Facility Registration Module goes “live” on
the Internet, allowing foreign manufacturers to register online.
Facilities may authorize outside individuals and companies to
register for them. A U.S. representative is required for registration
to facilitate communication between the FDA and the facilities
in the event of an emergency. |
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| December 12, 2003 |
Prior Notice Rules go into effect with published
guidance from Customs and FDA on how prior notice violations
will be penalized.
FDA
Compliance Policy Guide
Customs &
Border Protection (CBP) “Procedures for Bioterrorism Act
processing” |
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| December 15, 2003 |
| The Prior
Notice System Interface goes “live” allowing
importers to file their own prior notices. |
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