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Bioterrorism Act Rules. Registration and Prior Notice Deborah White Food Marketing Institute October 14, 2004. Welcome. A few notes up front… First webcast Recorded for future use Presentation with periodic opportunity for questions and then discussion at end

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bioterrorism act rules
Bioterrorism Act Rules



Prior Notice

Deborah White

Food Marketing Institute

October 14, 2004

  • A few notes up front…
  • First webcast
    • Recorded for future use
    • Presentation with periodic opportunity for questions and then discussion at end
    • Will appreciate your feedback on format as well as substance
bioterrorism act
Bioterrorism Act
  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002
    • Inevitable fall out from 9/11
    • Negotiated best legislative deal possible
    • Substantially less authority then FDA originally requested
bioterrorism act1
Bioterrorism Act
  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002
    • Inevitable fall out from 9/11
    • Negotiated best legislative deal possible
    • Substantially less authority then FDA originally requested
  • Four rulemakings relative to FDA’s food-related authorities
    • Registration
    • Prior notice
    • Records: maintenance & access
    • Administrative detention
registration and prior notice rules general
Registration and Prior Notice Rules: General
  • Issued on October 10, 2003 as “interim final rules”
    • Effective December 12, 2003
      • Enforcement discretion memorialized in Compliance Policy Guide
    • Public will have opportunity to comment until December 24, 2003
    • Comment periods reopened for 30 days in March 2004
  • FDA outreach
    • October 28 public meeting
    • Early November “grass roots” meetings
    • Working with state and foreign agencies to inform all constituencies
    • Tutorials
registration general
Registration: General
  • Owner, operator or agent in charge must register with FDA any facility engaged in manufacturing, processing, packing or holding food for consumption in the United States.
    • Owner, operator AND agent in charge are all liable
    • Any of these or an individual authorized by one of them may register
registration general1
Registration: General
  • Failure to register is a prohibited act subject to FD&C Act penalties
    • Civil injunctive relief
    • Criminal
  • Educational mode for first 4 months, except for public health emergencies
registration which facilities
Registration: Which Facilities?

Any facility engaged in manufacturing, processing, packing or holding food for consumption in the United States

  • Any establishment, structure or structures under one ownership in one general physical location (or multiple locations if a “mobile facility”)
    • Transport vehicles are not facilities if they only hold food to transport it.
  • Domestic and Foreign
registration which facilities1
Registration: Which Facilities?
  • Key Facility Exemptions
    • Farms
    • Restaurants
    • Deals in foods exclusively under USDA/FSIS jurisdiction, e.g., meat, poultry, eggs
    • Nonprofit food establishments
    • “Retail food establishments”
  • An entity that meets one of these definitions does NOT have to register
registration which facilities2
Registration: Which Facilities?
  • “Retail food establishment”
    • An establishment that sells food directly to consumers as its primary function
      • “Primary function” met if “annual monetary value of sales of food products to consumers exceeds the annual monetary value of sales of food products to all other buyers”
    • Applies even if the retailer conducts some processing activities provided that the “primary function” test is met
registration which facilities3
Registration: Which Facilities?
  • “Retail Food Establishment”
    • Exemption does not include warehouses, central kitchens, and distribution centers so they DO have to register
registration which facilities4
Registration: Which Facilities?
  • “Nonprofit Food Establishments”
    • Charitable entity that prepares or serves food or meals for consumption to humans or animals, eg, central food banks, soup kitchens
    • Must meet IRS 501(c)(3) criteria
registration which facilities5
Registration: Which Facilities?
  • “Food”
    • FDA revised definition of “food” in the final rule so that, for purposes of the Bioterrorism Act regulations, “food”

DOES NOT include food packaging

      • Facilities that only hold or store food packaging are NOT required to register
registration which facilities6
Registration: Which Facilities?
  • “Manufacturing, processing or holding”
    • To make food from one or more ingredients
    • Holding = storage [physical] of food; no exemption for temporary storage facilities
registration which facilities summary
Registration: Which Facilities Summary
  • All physical facilities at which food is manufactured, processed or held for consumption in the U.S. must be registered with FDA by December 12, 2003, unless one of the exemptions is met
  • Retail stores that sell more food to consumers than to businesses are exempt
registration what info required voluntary
Facility: name, address, phone

Parent: name, address, phone

Owner, operator, or agent in charge: name, address, phone number

Facility: fax, e.mail and preferred mailing address

Parent: fax, e.mail

Fax and e.mail addresses for same

Registration: What InfoRequired Voluntary
registration what info required voluntary1
Emergency contact phone number

Foreign facilities: name, address, phone number and emergency contact phone number for US agent

Emergency contact name, title and e.mail for domestic facilities

Foreign facility’s non-US emergency contact information

Registration: What InfoRequired Voluntary
registration what info required voluntary2
Trade name(s) of facility

Not brand names of products within facility

Food product categories (21 CFR 170.3)

“Most/All” is now an option

Certification that the information is true and accurate

Type of activity conducted at facility, including type of storage if primarily “holding” facility

Registration: What InfoRequired Voluntary
registration how to file
Registration: How to File
  • File Form 3537 with FDA
    • No fees
    • FDA will provide confirmation and registration number
registration how to file1
Registration: How to File
  • Electronic:

Available 10/16 @ 6:00 pm ET

FDA Registration Assistance:

1.800.216.7331 or 301.575.0156

registration how to file2
Registration: How to File
  • Paper (via mail or fax) or CD-ROM (pdf) also accepted
    • Multiple food facilities may be registered by CD-ROM (Format ISO 9660)
      • Info must be submitted on pdf version of Form 3537
      • CD-ROM must be accompanied by signed certification
      • Unlimited number of registrations, provided preferred mailing address is same for each
      • Each registration must have unique file name up to 32 characters long
        • First part may be used to identify parent company
registration when
Registration: When
  • Existing facilities must be registered by December 12, 2003
  • New facilities must register before they can begin operations
  • If you sell a facility, you must cancel your registration within 60 days
    • Window for new owner’s registration not clear
  • Any changes to required information must be submitted within 60 days on Form 3537a
registration other
Registration: Other
  • Registration information not releasable under Freedom of Information Act, unless one of exceptions applies
    • FDA will not release to states with “sunshine laws” that would require states to release the info
prior notice for imported foods general
Prior Notice for Imported Foods: General
  • Bioterrorism Act requires notice to be submitted to FDA before food may be imported into the United States as of December 12, 2003
prior notice general
Prior Notice: General
  • Notice must be given for all human or animal food imported into the US for use, storage, or distribution in the US, except the following:
    • Food packaging materials
    • Pesticides
    • Personal use or non-business gifts
    • Food that is imported and exported without leaving port of arrival
    • Foods under exclusive jurisdiction of USDA at time of import, e.g., meat, poultry, eggs
prior notice who
Prior Notice: Who
  • Prior notice may be submitted by any person with knowledge of the required information (aka “submitter”)
    • Significant change from proposal
    • Submitter may use another person to transmit the information to FDA (aka “transmitter”)
prior notice when
Prior Notice: When
  • Statute allows FDA to determine when information must be submitted
    • Between “minimum amount of time necessary to receive, review and respond to notice” and 5 days
    • Proposal: noon calendar day before arrival
prior notice when1
Prior Notice: When
  • Final rule: significant improvement
    • Timing depends on mode of transportation
    • Requested in comments filed by FMI and others
prior notice when2
Arrival by road 

Air and rail 

Water 

Internat’l mail 

2 hours prior

4 hours prior

8 hours prior

Before sending to US

Prior Notice: When
prior notice when3
Prior Notice: When
  • How early may prior notice be submitted?
    • No more than 5 calendar days prior to arrival, except for foods arriving by international mail
prior notice how
Prior Notice: How
  • Electronic submission required through either of the following:
    • Customs’ Automated Broker Interface/ Automated Commercial System (ABI/ACS)


    • FDA PN System Interface
  • unless the systems are not operational, in which case fax or e.mail may be used
prior notice how1
Prior Notice: How
  • FDA PN System Interface:

FDA Help:

1.800.216.7331 or 301.575.0156

prior notice when4
Prior Notice: When
  • Both ABI/ACS and FDA PN Interface System will be available electronically 24 hours per day, every day
    • FDA’s system will be operational on December 12, 2003
    • Tutorial available prior to that date
prior notice how2
Prior Notice: How
  • Upon receipt, FDA will issue:
    • Confirmation
    • PN Confirmation Number
  • Prior notice time commences at confirmation
  • PN Confirmation Number should accompany any article of food for which prior notice made through FDA system
    • Provide to FDA or Customs upon arrival
prior notice what
Prior Notice: What

Prior Notice must include the following:

  • Name, address, phone, fax and e.mail of person (and firm) submitting PN
  • Same information for “transmitter,” if applicable
  • Customs entry type identifier
    • Standard for CBP system; on-line help available with FDA system
prior notice what contd
Prior Notice: What (contd)
  • Product Identity:
    • FDA product code

(available at

    • Common, usual or market name
    • Estimated quantity – largest container to smallest package size (may be changed)
    • Lot or code numbers, if required by FD&C Act or regs (e.g., low acid canned food or infant formula)
prior notice what contd1
Prior Notice: What(contd)
  • Food in natural state: name and address of grower, if known
  • Food not in natural state: name, address and registration number of manufacturer and registration number assigned to facility
prior notice what contd2
Prior Notice: What(contd)
  • FDA “country of production”
    • Distinguished from USDA country of origin
    • Food in natural state:
      • Country where food was grown
      • For wild fish, flag on vessel
    • Food not in natural state:
      • Country where article was made
prior notice what contd3
Prior Notice: What(contd)
  • Name, address and registration number (if one) of shipper
  • Country of shipment
  • Anticipated arrival information (may be changed):
    • Port
    • Date and time
prior notice what contd4
Prior Notice: What(contd)
  • Name and address of importer, owner, and ultimate consignee
  • Mode of transportation
  • Standard Carrier Abbreviation Code or International Air Transportation Code of carrier (or name and country of carrier)
prior notice what contd5
Prior Notice: What(contd)
  • Planned shipment information, as applicable (may be changed):
    • Airway bill or bill of lading number
    • Vessel name and voyage number
    • Flight or trip number
    • Container or car number
  • Harmonized Tariff Schedule code
  • [whew…]
prior notice how3
Prior Notice: How
  • Changes
    • If information in prior notice changes, PN must be cancelled and refiled, except for the following:
      • Quantity
      • Anticipated arrival information
      • Planned shipment information
prior notice why
Prior Notice: Why
  • Food that arrives without proper prior notice may be refused admission and held at the attempted port of entry
    • With CBP concurrence, food may be immediately exported under CBP supervision
    • If notice untimely, food may still be admitted if FDA has already reviewed the PN and responded accordingly to Customs
  • Refused food may only be moved under custodial bond
    • FDA must be informed of location within 24 hrs of refusal
  • Neither FDA nor Customs is responsible for transportation, storage or other costs resulting from refusal of admission
prior notice why1
Prior Notice: Why
  • Importing or offering for import food without a prior notice is a prohibited act
  • FDA may bring civil actions for injunctive relief, criminal actions or seek debarment of any person who has committed a felony related to importation of food
  • Registration: paperwork
  • Prior Notice: paperwork plus logistical challenges
  • Possible implications for recordkeeping regulation
    • May be issued as an “interim” final rule, with an opportunity to comment
    • Likely to exclude food packaging materials and pesticides
    • May have longer effective date
    • Possibility of significant revisions to other broadly unacceptable aspects of regulation, such as lot code numbers
      • FDA might include lot code numbers only if required by FD&C Act or regulation, as set forth in prior notice rule
questions feedback

Comments to take to FDA...

Deborah White

Associate General Counsel,

Regulatory Affairs