Implications of the Bioterrorism Act on the Hospitality Industry

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Implications of the Bioterrorism Act on the
Hospitality Industry

• AHIAOctober 9, 2003
• James M. Goldberg

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• Public Health Security and
• Bioterrorism Preparedness and
• Response Act of 2002
• (Bioterrorism Act)
• Public Law 107-188

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Bioterrorism Act

• Signed into law on June 12, 2002
• Purpose to improve the ability of the United
  States to prevent, prepare for, and respond to
  bioterrorism and other public health emergencies

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Security of the U.S. Food Supply

• In Title III of the Act, Congress provided the
  Food Drug Administration with new authority to
  issue regulations to enhance the security of the
  U.S. food supply
• Registration of Food Facilities
• Establishment and Maintenance of Records
• Prior Notice of Imported Food Shipments
• Administrative Detention

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Statutory Deadlines

• December 12, 2003
• Registration of Food Facilities (Compliance)
• Establishment and Maintenance of Records (Final
  Rules)
• Prior Notice of Imports (Compliance)
• Administrative Detention does not have a
  statutory deadline, but FDA is developing a rule
  on the same timetable

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Registration of Food Facilities

• 68 Federal Register 58894
• October 10, 2003

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Who Must Register?

• Owners, operators or agents in charge of domestic
  or foreign facilities engaged in
  manufacturing/processing, packing or holding food
  for human or animal consumption in the U.S.
• Domestic facilities required to register whether
  or not food from the facility enters interstate
  commerce

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What Foods Are Included?

• Articles used for food or drink for man or other
  animals, chewing gum, and components of these
  articles
• Fruits and vegetables, fish and seafood, dairy
  products, eggs, raw agricultural commodities for
  use as food or food components
• Beverages, including alcohol beverages and
  bottled water

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What Foods Are Included?

• Canned foods
• Food additives
• Dietary supplements
• Bakery goods, snack foods and candy
• Final regulation exempts food contact substances
  (e.g., corks, packaging)

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The Rule Exempts

• Facilities regulated exclusively by USDA
• Farms, but not if processes food and ships to
  unrelated facility
• Fishing vessels not engaged in processing
• Retail food operations, restaurants
• If primary function (51 of sales ) is selling
  to consumers

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What Information Is Required?

• Name, address, phone number of the facility
• Name, address, phone number of the parent
  company, if the facility is a subsidiary
• Emergency contact phone number
• Names, address, phone numbers of owner, operator
  and agent in charge

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What Information Is Required?

• All trade names the facility uses
• Applicable food product categories
• A statement that the information submitted is
  true and accurate, and the name and contact
  information of the person submitting the
  statement
• Foreign facilities must also submit the name of
  the U.S. agent

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Requested Additional Information

• Optional additional information
• Preferred mailing address
• FAX number and e-mail address
• Type of activity conducted at facility
• Additional food product categories
• Type of storage
• Most/all food product category
• Approximate dates of operation, if seasonal

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Registration

• FDA strongly encourages electronic filing
• www.access.fda.gov
• Will not allow registration to be submitted until
  all mandatory fields completed
• Will provide automatic receipt of registration
  and facilitys registration number
• Paper registration accepted if internet not
  reasonably available, but much slower
• Form 3537

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Registration

• Registration is one-time, not annual
• No registration fee
• Updates requires within 30 days of change of any
  information previously submitted (mandatory or
  optional fields)
• Failure to register is a prohibited act

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Registration

• Imported food from an unregistered foreign
  facility shall be held at the port of entry until
  the facility is registered, unless FDA directs
  its removal to a secure facility
• Owner, importer or consignee must arrange for
  storage of the article of food in an
  FDA-designated secure facility

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Registration

• Must be done by December 12, 2003
• Facility must be registered, so is up to
  owner/landlord, lessee, operator, etc. to figure
  out who will register

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• Prior Notice of Imported
• Food Shipments
• 68 Federal Register 58974
• October 10, 2003

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Prior Notice

• Per the Act, prior notice must include identity
  of
• The article
• Manufacturer and shipper
• Grower (if known)
• Originating country
• Country from which it was shipped
• Anticipated port of arrival
• All statutory information, except grower, is
  currently provided to Customs at time of entry

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What Foods Are Included?

• Definition same as for registration

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Prior Notice Information Required

• Submitter identification
• Entry type and CBP identification
• Product identity
• FDA 7-digit product code
• Common/usual/market name
• Trade/brand name
• Quantity
• Identifiers lot/production code

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Prior Notice Information Required

• Manufacturer and shipper
• Name, address, including country
• Registration number
• Grower, if known (produce only)
• Country of production
• Country from which article was shipped
• Importer, owner or consignee
• Name, U.S. address, registration number

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Prior Notice Information Required

• Anticipated arrival information
• Location (port)
• Time
• Carrier
• SCAC (Standard Carrier Abbreviation Code)

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Who Provides Prior Notice

• Purchaser or importer of food article (or agent)
  who resides or maintains a place of business in
  the U.S.
• The arriving carrier or in-bond carrier, if the
  article of food is imported for in-bond movement
  through U.S. for export

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When Prior Notice May Be Given

• 2, 4 or 8 hours prior to arrival depending on
  mode of transportation
• Notice cannot be given more than five days prior
  to arrival
• Up to two hours before arrival
• Amendments to provide more specifics about
  product identity
• Updates to anticipated arrival information

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How Prior Notice May Be Given

• Must be submitted electronically via
  internet-based system
• www.access.fda.gov
• Will receive automatic confirmation of receipt
  with date and time
• Can be transmitted to FDA or through Customs
  Automated Broker Interface of the Automated
  Commercial System

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What If Information Changes?

• Amendments relates to product identity
• To allow submitter to provide specifics that did
  not exist at time of initial submission
• May be amended once
• Initial prior notice submission must indicate
  submitter will amend
• Cannot amend nature of the food (e.g., cant
  change fish to shrimp)
• Due not less than two hours before arrival

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What If Information Changes?

• Updates
• Required if anticipated arrival is one hour or
  more earlier than submitted, or three hours or
  more later than submitted
• Due not less than two hours before arrival
• All other changes must cancel initial prior
  notice and submit a new one

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What Happens If?

• Prohibited act to fail to provide notice
• If no notice/inadequate notice provided, article
  will be refused admission
• Article held at port of entry or in secure
  storage until proper notice is provided
• Transportation/storage costs borne by owner,
  purchase, importer or consigner

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• Establishment and Maintenance
• of Records
• Proposed May 9, 2003
• Final Expected December 10, 2003

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Who Must Keep Records

• Domestic persons (companies) that manufacture,
  process, pack, transport, distribute, receive,
  hold or import food intended for human or animal
  consumption in the U.S.
• Foreign facilities that manufacture, process,
  pack or hold food intended for consumption in the
  U.S.

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Who is Excluded?

• Restaurants
• Retail food operations are exempted from
  maintaining records on immediate subsequent
  recipients when foods are sold directly to
  consumers

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What Records Must Be Kept?

• Identify immediate non-transporter previous
  source (foreign or domestic) and immediate
  non-transporter subsequent recipient
• Name of firm, contact info (including individual)
• Type of food, including brand and variety
• Date received or released
• Lot number or other identifier

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What Records Must Be Kept?

• Contact information for transporter
• Inbound and outbound
• Can keep records in any format
• Can use existing records, if they contain
  required information
• Must maintain at establishment where activities
  occurred (onsite) or at a reasonably convenient
  location

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When Does Compliance Begin?

• Six months from publication of final rule
• 12 months for businesses with 11-499 employees
• 18 months for 10 or fewer employees