06 May 2003
U.S. Proposes Food Safety Record-Keeping Regulations
(Aims to help track food in case of contamination, other emergencies) (2010)
The U.S. government has proposed new regulations requiring elements of
the food industry to maintain records that would help officials track
food in case of an emergency, including terrorism-related
contamination, the Food and Drug Administration (FDA) of the U.S.
Department of Health and Human Services (HHS) announced.
In a May 6 news release, FDA said the proposed regulations would apply
to almost all foreign and domestic food sources and almost all
recipients of food destined for U.S. consumption.
The record-keeping rules and another set of proposed regulations
dealing with procedures for food detention are part of the FDA's
implementation of the Public Health and Bioterrorism Preparedness and
Response Act. The law, passed by Congress in 2002, gave the FDA new
authority to protect the U.S. food supply.
The proposal on record keeping would require manufacturers,
processors, packers, distributors, receivers, holders and importers of
food to keep records identifying the source of the food as well as the
subsequent recipient. Transporters such as trucking companies,
railroads and airlines would also be required to keep similar
documentation, FDA said.
Most foreign facilities would be excluded if their food products
undergo further manufacturing or processing, including packaging, by
another facility outside the United States. Also exempted would be
farms, restaurants, fishing vessels not engaged in processing, and
firms regulated exclusively by the U.S. Department of Agriculture.
The proposed regulation provides that a new final rule on record
keeping would become effective six months after its publication in the
Federal Register. FDA said it plans to publish such a rule no later
than December 12, 2003. Small businesses would be given additional
time to comply, FDA added.
The agency also issued proposed regulations dealing with the
procedures for detaining food that is believed to pose a credible and
serious health risk. The rules also cover the rights of people or
firms who have claim on the detained food.
Proposed rules concerning the registration of food facilities and
prior notice of imported foods were published in January 2003.
A fact sheet on the proposed record-keeping regulations is available
on the FDA website at:
A fact sheet on the proposed food detention procedures is available
Following is the text of the FDA news release:
U.S. Food and Drug Administration
Department of Health and Human Services
May 6, 2003
FDA Issues Final Two Proposed Food Safety Regulations
FDA today announced publication of the final two food safety proposed
regulations required by the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 ("The Act"), which gave FDA new
authority to protect the nation's food supply.
The proposals are two of four proposed regulations that the Act calls
upon FDA to develop regarding food safety. These two proposals deal
with establishing and maintaining records among food firms, and the
administrative detention of foods that may pose a risk to public
health. The other two proposals, concerning the registration of food
facilities and prior notice of imported foods, were published in
"Improving FDA's food safety inspection, detention and monitoring
capabilities is a top priority of the Department. We have taken strong
steps to enhance FDA's ability to make our food supply safer, said
Secretary of Health and Human Services Tommy G. Thompson. "This FDA
effort is the latest in a series of measures to build stronger
safeguards for the American people."
"These proposed regulations measures will further bolster FDA ability
to protect the more than 400,000 domestic and foreign facilities that
deal with food within our country," said FDA Commissioner Dr. Mark B.
McClellan, M.D., PhD. "Thanks to the efforts of Senators [Judd] Gregg
and [Edward] Kennedy, and Representatives [Billy] Tauzin and [John]
Dingell, the Bioterrorism Act gives FDA this important new authority."
The recordkeeping proposal is designed to help FDA track foods
implicated in future emergencies, such as terrorism-related
contamination. Under the proposed rule, manufacturers, processors,
packers, distributors, receivers, holders and importers of food would
be required to keep records identifying the immediate source from
which they received the food, as well as, the immediate subsequent
recipient, to whom they sent it. This requirement would apply to
almost all foreign and domestic food sources and almost all recipients
of food destined for consumption in the United States. It would assist
FDA in addressing credible threats of serious adverse health
consequences or death to humans or animals.
To minimize the economic burden on food companies affected by the
proposal, FDA's proposals would allow companies to keep the required
information in any form that they prefer. Records may be kept in any
format, paper or electronic, provided they contain all the required
information. The proposed rule also states that existing records can
be used to satisfy the requirements of the regulations if these
records contain all the required information.
For persons other than transporters the proposed rule would require
the records to contain the following information for each article of
-- The firm's name, and the responsible individual representative of
the firm that was the immediate previous source or the immediate
subsequent recipient of the food
-- The address, telephone and fax numbers, and e-mail address of that
person, if available
-- The type of food, including brand name and specific variety
-- The date received or released
-- Lot number or other identifier number, if available
-- The quantity and type of packaging
-- The name, address, telephone number -- and, if available, fax
number and e-mail address -- of the transporter who transported the
With respect to the immediate previous source, the specific source of
each ingredient that was used to make every lot of finished food
product would have to be identified if this information is reasonably
available. What is reasonably available may vary from case to case.
If an article of food is reasonably believed to be adulterated and
presenting a threat of serious adverse health consequence or death to
humans or animals firms would be required to provide these and other
records to FDA within four hours during certain business hours, or
eight hours at other times.
Transporters (e.g., trucking companies, private delivery carriers,
railroads and airlines) would also be required to keep similar
documentation -- including information about all the means of
The proposed rule would require records to be established at the time
the covered activity occurs. FDA is proposing that required records
for perishable foods not intended for processing into non-perishable
foods, and required records for animal food including pet food, be
retained for one year from the date they were created. Records for all
other foods would have to be retained for two years after the date
they were created.
Farms, restaurants, (including all operations that prepare food for,
or serve food directly to consumers), fishing vessels not engaged in
processing, and firms regulated exclusively by the U.S. Department of
Agriculture, would be exempted from the new recordkeeping
requirements. With some exceptions, foreign facilities would be
excluded if their food products undergo further
manufacturing/processing, including packaging, by another facility
outside the United States.
Retail food operations would be exempted from maintaining records on
immediate subsequent recipients of foods sold directly to consumers.
This proposed regulation provides that a final rule would become
effective six months from the date of publication of the final rule in
the Federal Register. For small businesses (fewer than 500 but more
than ten full-time equivalent employees) a final regulation would
become effective 12 months from that date, and for very small
businesses (ten or fewer full-time equivalent employees), the
effective date would be 18 months from publication of the final
FDA intends to publish a final rule no later than December 12, 2003,
in accordance with the deadline set forth in the Act. Given this
statutory deadline, FDA will not be able to extend the comment period
on this proposed rule.
The other proposed regulation on administrative detention implements
FDA's new authority to detain any article of food for which there is
credible evidence that the article poses a threat of serious adverse
health consequences or death.
The administrative detention authority granted to FDA under the Act is
self-executing and currently in effect, and provides an added measure
to ensure the safety of the nation's food supply. As required by the
Act, FDA is issuing this proposed rule that includes expedited
procedures for instituting certain enforcement actions against
perishable foods. The proposed rule also includes procedures
describing how FDA will detain an article of food and the process for
appealing a detention order.
Specifically, the proposed rule would require a detention order to be
approved by the FDA District Director of the district where the
detained article of food is located or a more senior official. A copy
of the detention order would be given to the owner, operator, and/or
agent in charge of the place where the article of food is located, and
to the owner of the food if different than those listed above. If FDA
issues a detention order for an article of food located in a vehicle
or other carrier used to transport the detained article of food, FDA
also would have to provide a copy of the detention order to the
shipper of record.
The detention order would provide the following information:
-- The detention order number
-- The hour and date of the order
-- The identification of the detained article of food
-- The detention period
-- A statement that the food identified in the order is detained for
the period shown
-- A brief, general statement of the reasons for the detention
-- And the address and location where the article of food is to be
detained and the appropriate storage and transportation conditions.
The proposed rule would require a detained article of food to be held
in a secure location, as determined by FDA. Detained food may not be
delivered to another entity, such as its importer, owner, or
consignee. Detained food also may not be transferred from the place
where it has been ordered detained, or from the place to which it has
been removed, until FDA releases the article or the detention period
expires. The detention may not exceed 30 days. Violation of a
detention order is a prohibited act.
Any person who is entitled to claim the detained article of food may
appeal the detention order. For perishable food, the proposed rule
would require an appeal to be filed within two calendar days of
receipt of the detention order. For non-perishable food, a notice of
intent to appeal would have to be filed within four calendar days, and
the appeal would have to be filed within ten calendar days of receipt
of a detention order. FDA is required to issue a decision within five
calendar days after an appeal is filed, after providing an opportunity
for an informal hearing. The decision rendered on appeal is considered
final agency action that may be challenged in court.
The definition of food used in the proposed rule references the
definition of food in section 201(f) of the Federal Food, Drug, and
Cosmetic Act and would include food intended for consumption both in
the U.S. and elsewhere. Food under the exclusive jurisdiction of USDA
(i.e., meat products, poultry products and egg products) is not be
covered by the administrative detention proposed regulation.
A comment period of 60 days will be provided on these proposals.
Written comments can be submitted to FDA at: Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061,
Rockville, MD 20852. Comments can also be submitted electronically
through www.fda.gov/dockets/ecomments. It is important to include
docket number 02N-0277 for the recordkeeping proposal and docket
number 02N-0275 for the administrative detention proposal when
providing comments. These proposals can also be accessed
electronically at the FDA web page on the Bioterrorism Act.
(Distributed by the Office of International Information Programs, U.S.
Department of State. Web site: http://usinfo.state.gov)