Bioterrorism Act Rules

1. Bioterrorism Act Rules Registration and Prior Notice Deborah White Food Marketing Institute October 14, 2004

2. Welcome • 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

3. 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

4. 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

5. 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

6. Registration of Food Facilities

7. 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

8. 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

9. 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

10. 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

11. 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

12. Registration: Which Facilities? • “Retail Food Establishment” • Exemption does not include warehouses, central kitchens, and distribution centers so they DO have to register

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. Registration: How to File • File Form 3537 with FDA • No fees • FDA will provide confirmation and registration number

21. Registration: How to File • Electronic: Available 10/16 @ 6:00 pm ET www.fda.gov/furls FDA Registration Assistance: 1.800.216.7331 or 301.575.0156 furls@fda.gov

22. 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

30. 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

31. 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

32. Prior Notice for Imported Foods

33. 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

34. 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

35. 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”)

36. 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

37. Prior Notice: When • Final rule: significant improvement • Timing depends on mode of transportation • Requested in comments filed by FMI and others

38. 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

39. 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

40. Prior Notice: How • Electronic submission required through either of the following: • Customs’ Automated Broker Interface/ Automated Commercial System (ABI/ACS) OR • FDA PN System Interface • unless the systems are not operational, in which case fax or e.mail may be used

41. Prior Notice: How • FDA PN System Interface: http://www.access.fda.gov FDA Help: 1.800.216.7331 or 301.575.0156 furls@fda.gov

42. 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

43. 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

44. 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

45. Prior Notice: What (contd) • Product Identity: • FDA product code (available at http://www.accessdata.fda.gov/scripts/ora/pca/pcb.htm) • 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)

46. 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

47. 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

48. 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

49. 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)

50. 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…]