September 28, 2005
Media Inquiries:
Michael Herndon , 301-827-6242
Consumer Inquiries: 888-INFO-FDA DHHS and DHS Issue Bioterrorism Act
Food Facilities Registration Final Rule
The U.S. Department of Health and Human Services (DHHS) is joining with
the U.S. Department of Homeland Security (DHS) today to announce the
issuance of a final rule implementing the food facilities registration
provision of the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act). The final rule confirms the
interim final rule on food facility registration that DHHS and DHS issued
in October 2003. The rule requires domestic and foreign facilities that
manufacture, process, pack, or hold food for consumption in the United
States to register with the U.S. Food and Drug Administration (FDA) by
December 12, 2003.
Information provided to FDA under this final rule will help the Agency
identify and locate promptly food processors and other establishments, in
the event of deliberate or accidental contamination of the food supply.
Except for specific exemptions, the registration requirements apply to all
facilities that manufacture, process, pack, or hold food, including animal
feed, dietary supplements, infant formula, beverages (including alcoholic
beverages and bottled water), and food additives.
"This rule is one of our critical tools for safeguarding the American food
supply," said Acting FDA Commissioner Andrew C. von Eschenbach, MD. "By
finalizing this rule, we now have another important safeguard in our
ongoing efforts to make sure that human and animal foods are protected
from a deliberate or accidental act of contamination."
The final rule announced today is one of five regulations issued by the
Agency to implement the Bioterrorism Act. In October 2003, DHHS and DHS
also jointly issued an interim final rule for prior notice of imported
food shipments, which requires that FDA receive advance notice of human
and animal food that is imported or offered for import into the United
States.
In June 2004, FDA published a final rule that specifies procedures that
FDA would use to administratively detain food when the agency has credible
evidence or information that the food presents a threat of serious adverse
health consequences or death to humans or animals. In December 2004, FDA
published a final rule requiring food firms to establish and maintain
records that would allow FDA to conduct an effective and efficient
traceback investigation to protect the U.S. human food and animal feed
supply, in the event the agency has a reasonable belief that an article of
food is adulterated and poses a threat of serious adverse health
consequences or death to humans or animals.
Together, these regulations increase the safety and security of the U.S.
human and animal food supply and better protect Americans from a
deliberate act of contamination of the food supply (such as a terrorist
act) or an incident of unintentional contamination that could lead to a
serious outbreak of food-borne illness. More information about each rule
may be found on FDA's website at www.fda.gov under the "Bioterrorism Act"
link.
FDA had previously indicated its plan to publish the Prior Notice Final
Rule along with the registration final rule. Publication of the
registration final rule is being announced today, and FDA and DHS/Customs
and Border Protection continue to develop as expeditiously as possible a
final rule that responds to the numerous comments the agencies received on
the Prior Notice Interim Final Rule.
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Federal Register Notice [PDF 32KB], September 28, 2005
http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0276-n000001.pdf
The complete text of the FDA/CBP News Release is posted at
http://www.fda.gov/bbs/topics/news/2005/new01236.html - A prepublication
copy of the Final Rule is posted at
http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0276-n000001.pdf - The final
rule is expected to be published on October 3 in the Federal Register at
http://www.access.gpo.gov/su_docs/fedreg/frcont05.html - Questions may be
directed to Catherine Copp who is with the FDA Center for Food Safety and
Applied Nutrition, Office of the Center Director, Office of Regulations
and Policy at 301 436 1589; e-mail: Catherine.Copp1@FDA.HHS.gov
http://www.fda.gov/bbs/topics/news/2005/new01236.html
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