Bioterrorism Act Updates

1
Bio-terrorism Act Updates

• FDA Responsibilities under the provisions of the
  Act
• Registration of Food Facilities
• Prior Notice Published
  January2003
• Record-keeping
• Administration Detention
  Published May 2003

2
Record- Keeping Proposal

• Designed to help FDA track foods implicated in
  future emergencies
• Under the proposed rule all stakeholders of the
  food chain would be required to keep records
  identifying from which they received as well as
  to whom they sent the food.
• The requirement is applicable to both domestic
  and foreign food sources destined for US
  consumption.
• To avoid economic burden on food stakeholders,
  they are allowed to keep the required information
  in any form they prefer

3
Record-keeping (contd.)

• Information required for record-keeping for all
  stakeholders except transporters include
• firms name and the responsible individual
  representative of the firm that was the
  immediate source and the immediate recipient of
  the food
• address, telephone, fax and e-mail address of the
  person
• type of food including brand name and specific
  variety
• date received or released
• Lot number or other identifier number
• quantity and type of packaging
• name, address, telephone number and if available,
  fax number and e-mail address of the transporter
  of food (identification of each and mode of
  transportation

4
Who must establish and maintain records?

• Persons that manufacture, process, pack,
  transport, distribute, receive, hold or import
  food intended for consumption in US
• Foreign facilities that manufacture, process,
  pack or hold food for human or animal consumption
  in US
• Trucking companies, private delivery carriers,
  railroads and airlines

5
Who are exempted from record-keeping?

• Farms - that sell unprocessed food grown in own
  or nearby farms including baked goods, jams,
  jellies, and maple syrups
• Restaurants and retail foods operations (that
  sell food directly to consumers)
• fishing vessels not engaged in processing
• firms regulated directly by the USDA
• foreign facilities whose products are to undergo
  further manufacturing/processing including
  packaging by another facility

6
Record Recall

• When food is reasonably believed to present
  health threat, the responsible firm is to provide
  its record to FDA within 4 hours for inspection
  and photocopying if request is made between 8am
  to 6pm.Monday to Friday or within eight hours if
  request is made at any other times.
• Required records for perishable foods not
  intended for processing and animal foods are to
  be retained for one year while for all other
  foods, two years from the date the record was
  created.

7
Effective dates

• 6 months from the date of the final rule
  publication in the Federal Register
• 12 months from that date - for small businesses
  (fewer than 500 workers or more than 10 full-time
  equivalent employees)
• 18 months from that date - for 10 or fewer
  full-time equivalent employee businesses
• STATUTORY DEADLINE OF THE FINAL RULE IS
• DECEMBER 12, 2003

8
Failure to establish and maintain record

• Failure to establish and maintain record or
• failure to make them available to FDA
• is a prohibited act
• that is subject
• to civil action in federal court

9
FDAs Administrative Detention Authority

• As required by the Act, FDA issues an expedited
  procedures to institute certain enforcement
  actions against perishable foods.
• The proposed rule also includes procedures
  describing how FDA will detain food and the
  process for appealing a detention order

10
Administrative Detention Procedure

• FDA District Director where food is detained
  approves detention order
• Copy of detention order is issued to
• owner, operator or agent in-charge of the place
  where food is detained
• owner of the food if different from above
• shipper of record if food issued a detention
  order is located in a transport vehicle

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Information in a detention order

• detention order number
• time and date of the order
• identification of the detained article of food
• statement of the detention period for the
  identified article of food
• a brief statement of the reasons for detention
• address and location where the article of food is
  to be detained and the appropriate storage and
  transportation conditions

12
Conditions for detained articles

• Detained food could only be moved when FDA
  releases the article or the detention period
  expires
• Detention should not exceed 30 days
• Persons entitled to claim detained article should
  appeal the detention order
• For perishable foods, appeal should be filed
  within two days of receipt of the detention
  order, for non- perishable it is 10 days but
  intent to appeal should be filed within 4 days
• FDA issue a decision within 5 days after an
  appeal is filed and after providing an
  opportunity for an informal hearing

13
Which foods are not covered by the FDA detention
authority

• All foods under the jurisdiction of the USDA
  which include
• Meat and poultry products
• egg products

14
Comments

• Establishment and Maintenance of Records (Docket
  No. 02N-0277)
• Administrative Detention (Docket Number 02N-0275)
• Send to www.fda.gov/dockets/ecomments or e-mail
  to fdadockets_at_oc.fda.gov.
• Deadline for both proposals - July 8, 2003

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• Thank you
• for your attention!