Implements the Recordkeeping Authority in the Bioterrorism Act
December 9, 2004, the FDA issued the last of the four regulations
that it promulgated pursuant to the Bioterrorism Act of 2001. (In
the Winter 2003 and Summer
2004 issues of FMLU, we discussed the
first three regulations pertaining to facilities registration,
import notification, and product detention.)
all businesses involved in the processing, manufacturing, transporting,
or storage of food will be required to maintain records that
can be produced, essentially upon demand, to FDA employees in
the event that FDA has a reasonable belief that food handled
by the business might present “serious adverse health consequences
or death to humans or animals” (a.k.a. “SAHCODHA” to
avid FMLU readers). Note that “food” includes
ingredients, dietary supplements, alcoholic beverages, animal feed,
as well as finished raw or processed food products.
This rule requires that domestic businesses establish and maintain
the records to be discussed below if they engage in any one or
more of the following activities involving food:
final rule also applies to foreign businesses that transport
food within the U.S. It does not apply to foreign owned
businesses that operate outside the U.S.
general, businesses covered by this rule must have available
records that show the immediate previous sources (e.g. ingredient
suppliers) and immediate subsequent recipients of food (e.g. purchasers
of finished product). The types of records that businesses
must maintain depends upon whether they are “transporters” or “nontransporters.” Transporters
include truckers, railroads and public warehouses. Nontransporters
include manufacturers, processors, packers and importers.
Transporters must maintain records of:
the immediate previous source and immediate subsequent recipient
the origin and destination of the food
the dates the food was received and released
a description of the food, and
quantity of food.
When nontransporters receive food, they must maintain records
contact information for the transporter
the immediate previous nontransporter source (e.g. supplier)
of the food
a description of the type of food
the date the food was received
the quantity, and
how the food was packaged.
When nontransporters ship food, they must maintain records of:
contact information for the transporter who receives the food
contact information for the immediate subsequent nontransporter
recipient of the food
a description of the type of food
date the food was released
the quantity, and
information that identifies the specific source of each ingredient
in the finished product.
on the type of food, the rule has different standards as to how
long records must be kept. The retention period
depends upon the spoilage (i.e. shelf life) of the food. Food
subject to spoilage:
60 days shelf life after shipment–the record
retention period for both transporters and nontransporters
is six months.
60 – 90 days shelf life after shipment–the
record retention period for both transporters and nontransporters
is one year.
less than 6 months shelf life after shipment–the
record retention period for nontransporters is two years
while for transporters is one year.
new rule contains numerous qualifiers and exceptions. For
example, it does not cover farms or retail sales, it does not include
products regulated exclusively by the USDA, and in the case of
packaging materials, it distinguishes between direct food contact
and indirect food contact packaging.
may be maintained in either paper or electronic form and they
must be retained either onsite or at a reasonably accessible
location offsite. Depending on the size of the business,
the final compliance date with this new recordkeeping regulation
ranges from December 9, 2005 to December 9, 2006. Violators
of the rule are subject to both criminal and civil actions.
try to figure out compliance at home! The rule is complicated
and convoluted. The
online version of the new rule and its accompanying comments is 344
double-spaced pages. Zackler & Associates
strongly recommends that you examine your business operations to
determine how you will be affected by these recordkeeping requirements.
If you are uncertain how this rule or any other aspects of the
Bioterrorism Act will impact your business, we are available to
assist you in auditing and modifying your current business practices
to assure compliance with all of the new Bioterrorism Rules.
FDA Withdraws Proposed Actions Over 5 Years Old -
On November 26, 2004 the FDA quietly withdrew about fifty proposals that were published in the Federal Register more than five years ago because they were no longer considered practical for final action. The FDA withdrew the proposals so that the agency could reduce its backlog and concentrate on higher priority activities.
A sample of the withdrawn proposals that may be of interest to FMLU readers include the following subjects:
- GRAS affirmation for brown and yellow mustard and their derivatives
- Deletion of GRAS status of caffeine
- Caffeine in nonalcoholic carbonated beverages
- Quality standards for bottled water
- Proposals to amend Standards of Identity of pineapple juice and canned pineapple
- Petitions to establish Standards of Identity of yogurt products
- Food labeling– compliance with net quantity of contents, nutrient content claims and health claims, available fat content, and serving sizes.
The FDA noted that the withdrawn proposals could be reinstated at a later date and that their withdrawal does not change FDA’s position on the subject matter of the withdrawn proposals.