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DE RUEHC #8138 2921950
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O 191930Z OCT 09
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TO ALL DIPLOMATIC AND CONSULAR POSTS COLLECTIVE IMMEDIATE
RUEHTRO/AMEMBASSY TRIPOLI IMMEDIATE 0353
RUEHRY/AMEMBASSY CONAKRY IMMEDIATE 2014

UNCLAS STATE 108138 
 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: EAGR ETRD ECON
SUBJECT: FDA REPORTABLE FOOD REGISTRY 
 
SUBJECT: 
 
¶1.      This is an action request.  Please see para 8. 
 
¶2.      On September 8, 2009, the U.S. Food and Drug 
Administration launched the Reportable Food Registry 
(RFR or the Registry), an electronic portal for industry 
to report when there is reasonable probability that an 
article of food will cause serious adverse health 
consequences to humans or animals.  The Registry helps 
the FDA better protect public health by tracking 
patterns of adulteration and targeting inspections. The 
Food and Drug Administration Amendments Act of 2007 
(Pub. L.110-085), section 1005 directs the FDA to 
establish a Reportable Food Registry for Industry.  The 
RFR applies to all FDA-regulated categories of food and 
feed, except dietary supplements and infant formula. 
 
¶3.      Food Facilities that manufacture, process, pack, or 
hold food for human or animal consumption in the United 
States (Responsible Parties) should be registered under 
section 415(a) of the FD&C Act (21 U.S.C. 350d), Such 
facilities are required to report via the RFR portal 
(http://rfr.fda.gov) within 24 hours if they find a 
reasonable probability that the use of, or exposure to, 
an article of food will cause serious adverse health 
consequences or death to humans or animals.  Federal, 
state, and local government officials may voluntarily 
use the RFR portal to report information that may come 
to them about reportable foods. 
 
¶4.      The reporting requirement applies to all foods and 
animal feed regulated by the FDA, except infant formula 
and dietary supplements, which are covered by other 
regulatory requirements. Some examples of reasons a food 
may be reportable include bacterial contamination, 
allergen mislabeling or elevated levels of certain 
chemical components. More information is available at 
www.fda.gov/ReportableFoodRegistry . 
 
¶5.      The opening of the RFR electronic portal reflects a 
fundamental principle of the President's Food Safety 
Working Group that "preventing harm to consumers is our 
first priority."  "President Obama has pledged to 
strengthen food safety," said Commissioner of Food and 
Drugs Margaret A. Hamburg, M.D. "The opening of the 
Reportable Food Registry electronic portal represents a 
significant step toward that pledge."  "By fostering 
real-time submission to the FDA of information on food 
safety hazards, the registry enhances FDA's ability to 
act quickly to prevent foodborne illness," said Michael 
¶R. Taylor, senior advisor to the Commissioner. "Working 
with the food industry, we can swiftly remove 
contaminated products from commerce and keep them out of 
consumers' hands." 
 
 
¶6.      A Responsible Party must 1) Investigate the cause 
if the adulteration of food may have originated with the 
responsible party, 2) submit initial information, 
followed by supplemental reports, and 3) work with FDA 
to follow up as needed. A Responsible Party is not 
required to report if the adulteration originated with 
the responsible party and it found the problem before 
the food was shipped and corrected the problem or 
destroyed the food. 
 
¶7.      In emergencies, consumers, food retailers and food 
service operators should continue to call FDA at 301- 
443-1240. For less urgent problems, contact the FDA 
consumer complaint coordinator in your geographic area 
or see Your Guide to Reporting Problems to FDA.  For 
more information see The RFR Guidance at 
www.fda.gov/ReportableFoodRegistry 
Consumer Inquiries: 888-INFO-FDA. 
 
¶8.      ACTION REQUEST: Posts draw from the information in 
points 2 through 7 to discuss this issue with the 
appropriate Ministries.  Where FAS or HHS officials are 
present, Econ officers should coordinate delivery of the 
talking points.  Please report substantive comments only 
via cable, at or below the SBU level.  If you have 
questions regarding this program, please contact 
Vashti.Klein (vashti.klein@fda.hhs.gov) or Ann Ryan 
(ryanam@state.gov). 
CLINTON