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From: Terry S. Singeltary Sr. (216-119-129-46.ipset9.wt.net)
Subject: Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Date: December 9, 2004 at 7:44 am PST

-------- Original Message --------
Subject: Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Date: Thu, 9 Dec 2004 09:36:24 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE


##################### Bovine Spongiform Encephalopathy #####################

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 11

[Docket No. 2002N-0277]
RIN 0910-AC39


Establishment and Maintenance of Records Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing a final
regulation that requires the establishment and maintenance of records
by persons who manufacture, process, pack, transport, distribute,
receive, hold, or import food in the United States. Such records are to
allow for the identification of the immediate previous sources and
immediate subsequent recipients of food. The final rule implements the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (the Bioterrorism Act), and is necessary to help address
credible threats of serious adverse health consequences or death to
humans or animals. The requirement to establish and maintain records is
one of several tools that will help improve FDA's ability to respond
to, and further contain, threats of serious adverse health consequences
or death to humans or animals from accidental or deliberate
contamination of food. In the event of an outbreak of foodborne
illness, such information will help FDA and other authorities determine
the source and cause of the event. In addition, the information will
improve FDA's ability to quickly notify the consumers and/or facilities
that might be affected by the outbreak.

DATES: Effective Date: This final rule is effective February 7, 2005.
Compliance Dates: The compliance date is December 9, 2005; except
that for small businesses employing fewer than 500, but more than 10
full-time equivalent employees, the compliance date is June 9, 2005;
and except that for very small businesses that employ 10 or fewer full-
time equivalent employees, the compliance date is December 11, 2006.

FOR FURTHER INFORMATION CONTACT: Nega Beru, Center for Food Safety and
Applied Nutrition (HFS-305), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 301-436-1400.

SUPPLEMENTARY INFORMATION:

snip...

Table of Contents

(Comment 56) Two comments requested clarification on whether the
exemption from the recordkeeping requirements for non-BSE regulated pet
food manufacturers applies to foreign manufacturing facilities.
(Response) All foreign persons, except foreign persons who
transport food in the United States, are excluded from all of these
regulations under Sec. 1.327(h) of this final rule. In addition, the
final rule deletes the proposed exclusion for non-BSE regulated pet
food. Accordingly, all persons who manufacture, process, pack,
transport, distribute, receive, hold, or import animal feed in the
United States, including pet food, are subject to the requirements of
this final rule, unless otherwise exempted.
(Comment 57) FDA received three comments from four national animal
feed trade associations. One disagrees with the proposal to exempt pet
food entities that are not subject to the BSE rule. It comments that it
was an error to attempt to combine provisions of the BSE rule with a
Bioterrorism rule. Because the BSE rule was solely designed to prevent
the introduction and amplification of BSE, the comment is concerned
that the recordkeeping requirements of the BSE rule do not fully
address the recordkeeping provisions of the Bioterrorism Act. In
addition, it comments that the health and safety of pets should not be
compromised and, therefore, all animal food should be treated equally
under the final rule and pet food companies should be required to
maintain the same level of records as other animal feed companies. The
comment also notes that creating an exempt category of food products
(i.e., certain pet foods) could result in a gap in the recordkeeping

[[Page 71583]]

system established by the Bioterrorism Act.
Two additional animal feed associations submitted a combined
comment that for simplicity FDA should adopt the same recordkeeping
requirements for all animal food, pet food, and food intended for food-
producing animals. One comments that entities already complying with
the BSE rule should comply but all other animal feed and pet foods
should be exempt from the recordkeeping requirement because of the low
risk of serious adverse health consequence. Two comments state that
they agree with FDA's risk assessments that animal feed and pet food
have a lower risk and therefore needs fewer requirements than human
food.
One other comment supports the proposed provision stipulating that
BSE-regulated pet food entities should comply with the recordkeeping
regulations. A foreign comment questions the need for the inclusion of
any animal feed or pet food in the rule. Several comments, foreign and
domestic, request clarification on which foreign establishments are
subject to the recordkeeping requirements under the proposed non-BSE
rule exclusion.
(Response) In the final rule, FDA has deleted the non-BSE pet food
exclusions, and the final rule now requires all animal feed and pet
food entities to establish and maintain records for 1 year. Therefore,
the definition of pet food in the proposed rule is no longer needed and
has been deleted. FDA was persuaded by the comments from three national
trade organizations that: (1) Using the scope of the BSE rule as the
criterion for exempting certain pet foods is inappropriate and would
result in insufficient recordkeeping coverage to protect the public
from bioterrorism; (2) creating an exclusion for certain pet foods
could create a gap in the recordkeeping system; and (3) for simplicity,
FDA should adopt the same recordkeeping requirements for all animal
food, including pet food. FDA believes that contaminated animal food
can be a link to human foodborne illness. People could be at risk
through direct contact with animal food or through unintentional cross-
contamination of cooking surfaces or utensils. Animals may also become
infected and serve as a reservoir for exposing other animals and humans
to disease. In 2002, dog chew treats were contaminated with Salmonella
enteritidis (Salmonella) and became a vehicle to transmit Salmonella
into homes. As a consequence, many pet owners became ill, and one
person died (Ref. 15). Although FDA continues to believe that the
consequences of a potential terrorist attack or food-related emergency
are greater for food for food-producing animals than for pet food,
compelling arguments have been raised against the proposal to create
exclusions for certain pet food entities. Therefore, FDA believes that
applying the recordkeeping requirements uniformly to all animal foods
is most consistent with the intent of the Bioterrorism Act.
The final rule requires records for all animal food, including pet
food, to be retained for 1 year after the dates you receive and release
the food. FDA believes that a 1-year period of records retention is
appropriate because food for food producing animals tends to have a
faster turnover rate than many kinds of human food. In addition, since
pet foods are typically the sole source of food for pets, such foods
tend not to be stored as long as many human foods.
(Comment 58) One comment states that the recordkeeping requirements
for animal food foreign establishments should be limited to the final
establishment handling the product prior to export to the United
States.
(Response) Section 1.327(h) of this final rule excludes all foreign
persons, except foreign person who transport food in the United States,
from all requirements in this final rule.
(Comment 59) One comment asks FDA to officially recognize its
country's BSE regulations as equivalent to the U.S. BSE regulations.
(Response) FDA declines to respond to this request because it is
outside the scope of this rulemaking.
(Comment 60) One comment asks that suppliers and transporters of
animal food not be required to retain any additional information other
than what is contained in their current records.
(Response) FDA agrees in part with this comment. This rule only
requires additional records to be established and maintained to the
extent the information does not already exist.

snip...

12. Pet Food
There were no comments on the definition of pet food, however, FDA
has decided to include all animal feeds, including pet food, under
these regulations. Therefore, there is no longer a need to define the
term ``pet food'' and FDA has deleted this definition from the final
rule.

snip...

full text;

http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-26929.htm

http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-26930.htm


Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC-254


http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm


TSS

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