FDA on Dec. 9, 2004 issued final
regulations implementing the section of the Bioterrorism Act that
requires entities to maintain and provide access to records. FDA’s
regulations require that firms maintain records sufficient to
identify the immediate previous source of incoming agricultural
commodities and the immediate subsequent recipient of outbound
products – in effect, one-step-forward and one-step back
recordkeeping.
Covered by the recordkeeping requirements
are U.S. firms and persons that manufacture, process, store, pack,
transport, distribute, receive or import food, feed or feed ingredients.
This includes country, terminal and export grain elevators; commercial
feed mills; corn and soy processing plants; pet food manufacturers;
feed ingredient manufacturers; and transporters (including railroads,
barges and commercial truckers).
Among those that are exempt
from the recordkeeping requirements are:
- Farms, including integrated livestock
and poultry operations provided the activities of such establishments
are limited to “growing or raising” farm animals
for human food, but do not extend into further processing of
food-producing animals into meat, milk or eggs.
- Foreign facilities, except for
foreign transporters hauling agricultural commodities or food
into the United States.
- Retail establishments, including
feed and farm supply stores and pet food retail stores, provided
that such establishments ship products directly to consumers
and final purchasers. This exemption applies unless the feed
is to be used in animals that subsequently will be sold as food;
in this case, the purchasers are not considered to be consumers
since they are purchasing the food or feed for a business (i.e.,
for a food-producing operation).
- Restaurants.
What’s
Required
FDA’s regulation requires persons
or firms to maintain records when they receive a food, agricultural
commodity, feed or feed ingredient, as well as when they release
or ship it to a different U.S. or foreign company or entity. Intra-company
records – that is, records relating to the movement of commodities
between facilities owned by the same corporate entity –
are exempt; but records are required once the commodity is transferred
to a transporter for shipment to another company or entity.
For non-transporters, such as grain
elevators, feed manufacturers and grain/oilseed processing plants,
the records are required to be sufficient to:
1. Identify the immediate non-transporter
sources, whether foreign or domestic, of all commodities, feed,
feed ingredients and food received. Such information is to include:
- Source firm or entity’s
name, as well as its address, telephone number, fax number and
e-mail address (if available);
- type of agricultural commodity,
food or feed/ingredient, etc., received, including the brand
name and specific variety (if applicable);
- transporter from which the products
were received, including its name, address, telephone number
and, if available, its fax number and e-mail address; and
- Lot or code number for the product
if one exists.
2. Identify the immediate non-transporter
subsequent recipient to which the commodities, feed, feed ingredients
or food is shipped. Such information is to include:
- recipient firm’s name, as
well as its address, telephone number, fax number and e-mail
address (if available);
- type of agricultural commodity,
feed or feed ingredient, etc., shipped, including any brand
name and specific variety (if applicable);
- The date released.
- The quantity and type of packaging
(e.g., bulk, bagged, etc.).
- The identity of the transporter
used to ship the product, including the name, address, telephone
number and, if available, the fax number and e-mail address
of the transporter.
- Lot or code number for the product
if one exists.
The records are required to contain
information that is “reasonably available” to identify
the specific source of each product/ingredient used to make every
lot of a finished product. But importantly, FDA acknowledges that
for facilities that handle, store and ship products on a commingled
basis, it will be sufficient to identify all potential sources
from which commodities contained in a bin or conveyance, and not
to link specific portions of the commingled mass to individual
shipments or deliveries.
FDA does not require firms to create
new records or to consolidate records, so long as the required
information exists and can be made available to the agency within
24 hours of its request. Records can be maintained at individual
facilities or at company headquarters – again provided the
information is made accessible upon request within 24 hours.
For non-transporters, records are required to be retained for:
- Six months for entities handling
products and foods having a significant risk of spoilage, loss
of value or loss of palatability within 60 days.
- One year for animal feed, including
pet food.
- One year for products and foods
having a significant risk of spoilage, loss of value or loss
of palatability within 60 to 180 days.
- Two years for agricultural products
and foods that do not have a significant risk of spoilage, loss
of value or loss of palatability for 180 days or longer. This
would apply to most grains, oilseeds and raw agricultural commodities.
Persons and firms are
required to comply with the recordkeeping requirements by:
- By Dec. 9, 2005 for most firms.
- By June 8, 2006 for small firms
that have 11 to 499 full-time equivalent employees.
- By Dec. 9, 2006 for extremely
small firms that have 10 or fewer full-time equivalent employees.
Importantly, FDA under the Bioterrorism
Act has the authority to access such records only if it receives
a “credible threat of serious adverse health consequences
or death” to humans or animals.
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