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May 2003
The Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act
or the Act) requires the Secretary of Health and Human Services to issue final
regulations by December 12, 2003, that would establish requirements regarding
the establishment and maintenance, for not longer than two years, of records
by persons (excluding farms and restaurants) who manufacture, process, pack,
transport, distribute, receive, hold, or import food. The records that must
be kept by these regulations are those that are needed by the Secretary for
inspection to allow the Secretary to identify the immediate previous sources
and immediate subsequent recipients of food, including its packaging, in order
to address credible threats of serious adverse health consequences or death
to humans or animals. This proposed regulation would implement this recordkeeping
authority in the Bioterrorism Act.
Who must establish and
maintain records under the proposal? Domestic persons that manufacture,
process, pack, transport, distribute, receive, hold or import food intended
for human or animal consumption in the U. S. and foreign facilities that manufacture,
process, pack or hold food intended for human or animal consumption in the U.S.
Who is excluded from
these regulations? Farms; restaurants; non-profit operations that prepare
food for, or serve food directly to, consumers; fishing vessels not engaged
in processing; and persons regulated exclusively by the U.S. Department of Agriculture
under various statutes. A foreign facility is excluded if food from it undergoes
further manufacturing/processing (including packaging) by another facility outside
the U.S. The facility is not exempted from recordkeeping if the processing or
packaging activities of the subsequent facility are limited to the affixing
of a label to a package or other de minimis activity. The facility that conducts
the de minimis activity also must establish and maintain records. Retail food
operations also are exempted from maintaining records on immediate subsequent
recipients when foods are sold directly to consumers. However, retail facilities
with fewer than 10 employees that are located in the same general location as
a farm, and sell unprocessed food grown on that farm or another farm located
in the same general physical location are excluded from the requirement to establish
and maintain records on both immediate previous sources and immediate subsequent
recipients. This exemption also applies to processed foods such as baked goods,
jams, jellies, and maple syrup so long as all the ingredients were grown or
raised on that farm. In addition, persons who manufacture, process, pack, transport,
distribute, receive, hold or import pet food who are not subject to the recordkeeping
provisions of the animal proteins prohibited in ruminant feed regulation (21
CFR 589.2000) are, with respect to pet food records, excluded from the requirement
to establish and maintain records on both immediate previous sources and subsequent
recipients.
What records must be
established and maintained? For manufacturers, processors, packers, distributors,
receivers, holders and importers of food (that is, persons other than transporters),
the records would have to:
- Identify the immediate
non-transporter previous sources, whether foreign or domestic, of all foods
received, including the name of the firm and the responsible individual; address;
telephone number; fax number and e-mail address, if available; type of food,
including brand name and specific variety (e.g., Brand X Cheddar Cheese, not
just cheese; romaine lettuce, not just lettuce); date received; lot number
or other identifier if available; quantity and type of packaging (e.g., 12
oz. bottles); and the name, address, telephone number--and, if available,
fax number and e-mail address--of the transporter who brought it. The records
must include information that is reasonably available to identify the specific
source of each ingredient that was used to make every lot of finished product.
- Identify the immediate
non-transporter subsequent recipients of all foods released, including the
name of the firm and the responsible individual; address; telephone number;
fax number and e-mail address, if available; type of food, including brand
name and specific variety; date released; lot number or other identifier if
available; quantity and type of packaging; and the name, address, telephone
number--and, if available, fax number and e-mail address--of the transporter
who transported the food from you.For transporters, the records for each food
transported would have to include:
1.The name of the firm
and the responsible individual who had the food before you and their address,
telephone number, and, if available fax number and e-mail address, and the
date you received it.
2. The name of the firm
and the responsible individual who had the food immediately after you and
their address; telephone number, and, if available, fax number and e-mail
address, and the date you delivered it.
3. The type of food, including
brand name and specific variety; lot number or other identifier if available,
quantity, and type of packaging.
4. Identification of each
and every mode of transportation used (e.g., company truck, private carrier,
rail, air, etc.) and the individual responsible from when the food was first
received until it was delivered.
How must the records
be maintained? FDA is specifying the information a covered entity must keep
but not specifying the form in which the records must be maintained. The records
may be kept in any format, paper or electronic, provided they contain all the
required information.
Can existing records
be used to satisfy the requirements of these regulations? The proposed regulations
do not require duplication of existing records, if these records contain all
the required information.
How long must the records
be retained? The proposed rule would require records to be created when
food is received, released or transported. Records for perishable foods not
intended for processing into non-perishable foods, as well as records for animal
food including pet food, would have to 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.
Where must the records
be retained? At the establishment where the activities covered in the records
occurred (onsite) or at a reasonably accessible location.
What are the record availability
requirements? When FDA has a reasonable belief that an article of food is
adulterated and presents a threat of serious adverse health consequences or
death to humans or animals, any records or other information to which FDA has
access must be available for inspection and photocopying or other means of reproduction
within 4 hours if the request is made between 8:00 am and 6:00 pm, Monday through
Friday, or within 8 hours if the request is made at any other time.
What records are excluded
from these proposed regulations? Recipes, financial data, pricing data,
personnel data, research data and sales data are excluded from these requirements.
FDA is proposing to define recipe as the quantitative formula used in the manufacturing
of the food product, but not the identity of the individual ingredients of the
food. If finalized as proposed, FDA would have access to the records containing
the ingredients used in a food product, but would not have access to the quantities
of the ingredients used to make a product.
What will happen if the
required records are not established and maintained? The Bioterrorism Act
makes failure to establish and maintain the required records or failure to make
them available to FDA a prohibited act. The Federal government can bring a civil
action in Federal court to enjoin persons who commit a prohibited act; or the
Federal government can bring a criminal action in Federal court to prosecute
persons who commit a prohibited act.
When would the recordkeeping
requirements take effect? You do not have to comply with the proposed rule.
However, there are certain statutory provisions regarding access to records
and other information by FDA that are already in effect. You do have to comply
with these statutory provisions. After considering comments FDA receives on
the proposed rule, FDA will publish a final rule. The proposed rule would require
all businesses, except small and very small businesses, to comply with the final
rule 6 months from its publication rule in the Federal Register. Small
businesses (fewer than 500 but more than 10 full-time equivalent employees)
would have to comply within 12 months from publication of the final rule, and
very small businesses (10 or fewer full-time equivalent employees) would have
to comply within 18 months from publication of the final rule.
How to Comment on Proposed
Regulations: Under U.S. law, proposed regulations are published in the Federal
Register to provide interested parties with an opportunity to submit comments,
e.g., suggestions to make the proposal more effective or less burdensome, questions
regarding the agency's data or assumptions, submission of information the agency
may not have, etc. FDA will consider all timely comments that it receives as
it develops the final recordkeeping rule, which will be published in the Federal
Register. Regularly updated information on this regulatory proposal and
how to comment on it can be accessed electronically at http://www.fda.gov/oc/bioterrorism/bioact.html.
Comments on this proposed
regulation, Establishment and Maintenance of Records (Docket Number 02N-0277),
will be accepted until July 8, 2003. Written comments on the proposal can be
sent to the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments can be sent electronically
to www.fda.gov/dockets/ecomments or as an e-mail to fdadockets@oc.fda.gov.
Please ensure that you include in your submission the docket number that applies
to your comment: Recordkeeping - Docket No. 02N-0277.
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