Company Important Information: 2002 Bioterrorism Act
is much legal assistance needed for companies in the food,
beverage and nutrient supplement industries. FDA regulatory
and labeling matters, as well as trademark and other intellectual
property work require much legal guidance. Whether it involves
advertising, marketing or distribution matters, good legal
counsel can protect a company from many dangerous situations.
What follows is a brief presentation of some of the facts
about the 2002 Bioterrorism Act.
FDA has published for comment its second and final set of
proposed rules to implement the mandates of the 2002 Bioterrorism
Act. As reported in the Winter 2003 issue of Food & Marketing
Law Update, the agency previously published rules pertaining
to facility registration and prior notice to the FDA of the
importation of food products into the United States. The
new proposed rules cover record keeping requirements for
the receipt and shipment of food from processor to retailer
and the circumstances and procedures under which the FDA
can administratively detain inventories of food products.
Everyone in the Food Business Will Be Affected
On January 29, 2003 the FDA published Federal Register notices for two sets
of proposed rules to implement two of the four required FDA mandates in the
Public Health Security and Bioterrorism Preparedness and Response Act of 2002
(the “Bioterrorism Act.”). The requirements of these four mandates
will fundamentally affect the business practices of many domestic and foreign
firms that sell food (including dietary supplements) in the United States.
The two published notices are for rules that (a) require, with certain exceptions,
the registration with the FDA of every domestic and foreign facility that processes,
packs or stores food that is sold in the US and (b) require prior notice to
the FDA of every shipment of food imported into the US. The FDA intends to
have these rules finalized and its Internet based 24/7 registration and import
notice systems operational by October 12, 2003. Any person or firm who fails
to register a covered facility by December 12, 2003 or who imports food into
the United States after December 12, 2003 without providing prior notice to
FDA will be in violation of the act and subject to civil and criminal sanctions.
The FDA had delayed the publication of the proposed rules to implement the
two other mandates in the Bioterrorism Act. One mandate requires that all businesses
that manufacture, process, pack, transport, store, or import food into the
United States keeps a paper trail of all suppliers of the food and the persons
to whom the food be sold. We anticipate that these rules will require food
manufacturers and processors to keep batch-by-batch records of the sources
of ingredients used to make their products. This rule must also be effective
no later than December 12, 2003.
The fourth mandate gives the FDA new authority to administratively detain (i.e.
without court order) any food that the agency has evidence or information that
the food presents a threat of a serious adverse health consequence to either
humans or animals. The legislation mandating this rule does not require any
association with terrorist threats or activity. There is no deadline for implementation
of this rule.
The two proposed rules that have been published by the FDA are far too complex
to fully detail in this article. However, some significant items to note are:
Facility Registration Rule
include businesses involved in the production and distribution
of food packaging materials
mean specific physical locations such as individual plants,
warehouses, or retail stores which also engage in wholesale
activities (e.g. Costco).
updates must be reported to the FDA within 30 days.
foreign facilities must have a US based agent. (Currently
this requirement only applies to foreign drug manufacturers.)
from registration are farms (including fish farms) which
only engage in the sale of raw agricultural products, restaurants,
grocery stores, non-profit food establishments (e.g. soup
kitchens and food banks), fishing boats that do not engage
in on-board processing, facilities subject to USDA regulation
and foreign facilities that send food to other foreign
facilities for further processing or packing prior to export
to the US. Note that mixed facilities, which have both
exempt and non-exempt operations, must be registered.
food will not be allowed into the US if it was produced
at an unregistered, non-exempt foreign facility.
Proposed Import Notification Rule
will be responsible for compliance with this rule
will be a stand-alone system. (The FDA has stated that
it will continue to work with US Customs to create a unified
of food, which have not been registered, will be either
refused entry or stored at a secure facility at the importer’s
definitions of country of origin and port of entry are
different from the Customs definitions.
notices may be filed no earlier than 3 days before the
anticipated entry date of the shipment into the US and
no later than noon of the day before entry.
notice will be required for each “article,” which
appears to be equivalent to an SKU.
notices will require up to 13 elements of information including
Customs numbers, identification of foreign manufacturer,
type of food based on FDA 7 digit product codes, lot code
country of origin, identification of importer and carrier.
amendments of the notices as to quantity, port of entry,
time of entry will be permitted up to two hours before
arrival. No amendments will be allowed as to the type of
It is strongly recommended that if you are in a related food company that
this pertains to that you now begin examining your business operations to
determine how you might be affected by these new rules. You may very well
need professional assistance in that examination and in the establishment
to new systems to assure seamless compliance when the rules become effective.
is very grateful that Attorney Allan I. Zackler has provided
this valuable information for our business owners in food
businesses. Attorney Allan I. Zackler offers regular articles
and information at his site http://www.foodlaw.com .
BusinessPlans.com in no way represents themselves as providing
any legal advice or opinion on any of the above matters.