Overview of Registration and Prior Notice Interim Final Rules Implementing the Bioterrorism Act

1

• Overview of Registration and Prior Notice Interim
  Final Rules Implementing the Bioterrorism Act
• November 21, 2003
• Louis J Carson
• Deputy Director, Food Safety and Security Staff
• Center for Food Safety and Applied Nutrition

2
Background FDAs Regulatory Development Timeline

• Feb. 3, 2003 FDA and Customs and Border
  Protection (CBP) published proposed rules with a
  60 day comment period
• FDA received over 350 comments on registration
  and over 470 comments on prior notice
• Oct. 10, 2003 FDA and CBP published interim
  final rules (registration system operational on
  Oct. 16, 2003)

3
Background FDAs Regulatory Development Timeline

• Oct. 28, 2003 Public meeting via satellite
  downlink to domestic and international sites
• Satellite downlink transcripts will be available
  in English, French Spanish
• Outreach materials will be available on FDAs
  website in Arabic , Chinese, French, Hindi,
  Japanese, Malay, Portuguese, and Spanish
• http//www.fda.gov Click on Bioterrorism

4
Background FDAs Regulatory Development Timeline

• November 2003 FDA plans to publish a Compliance
  Policy Guide (CPG) outlining how we will exercise
  our enforcement discretion for the initial months
  following the Dec. 12th effective date
• CPG will focus in part on educating affected
  parties
• Dec. 12, 2003 Interim final rules take effect
  and prior notice systems operational

5
Background FDAs Regulatory Development Timeline

• Dec. 24, 2003 Comments due on interim final
  rules
• March 2004
• FDA and CBP will publish a plan and
  implementation schedule to achieve the goal of a
  uniform, integrated system and to coordinate
  timeframes for implementing prior notice
  information
• Comment period for IFR will reopen

6
What Is An Interim Final Rule (IFR)?

• An IFR is a final rule that has the full force
  and effect of law thus, affected parties have an
  obligation to comply with its requirements
• An IFR allows stakeholders to submit comments
  during the public comment period on the areas
  requested in the interim final rule that the
  agency will consider before deciding whether to
  issue a revised final rule or confirm the interim
  final rule as final

7
Registration of Food FacilitiesInterim Final
Rule68 FR 58894 (Oct. 10, 2003)

• Sec. 305 The Secretary shall be regulation
  require that any facility engaged in
  manufacturing, processing, packing or holding
  food for consumption in the United States be
  registered with the Secretary . . . By

8
Registration of Food FacilitiesInterim Final
Rule68 FR 58894 (Oct. 10, 2003)

• Sec. 305 The Secretary shall be regulation
  require that any facility engaged in
  manufacturing, processing, packing or holding
  food for consumption in the United States be
  registered with the Secretary . . . by December
  12, 2003.

9
Who Must Register?

• Owners, operators, or agents in charge of
  domestic or foreign facilities that
  manufacture/process, pack, or hold food (subject
  to FDAs jurisdiction) for human or animal
  consumption in the U.S.
• Domestic facilities are required to register
  whether or not food from the facility enters
  interstate commerce

10
Who Must Register?(cont.)

• Owners, operators, or agents in charge may choose
  to authorize an individual to register on behalf
  of the facility
• The requirement applies to each covered facility,
  not to firms or companies as a whole
• E.g., company with 10 facilities must register
  each one separately

11
U.S. Agent

• Foreign facilities are required to have a U.S.
  agent can be any person that resides or
  maintains a place of business in the U.S. and is
  physically present in the U.S.
• Person" is defined as an individual,
  partnership, corporation, or association
• The U.S. agent acts as a communications link
  between FDA and the facility for both routine and
  emergency communications, unless the facility
  opts to designate a different emergency contact

12
U.S. AgentFrequently Asked Questions

• Liability
• Costs/FDA Recommendation
• Embassy personnel as U.S. Agents
• U.S. Agent vs. sales agents vs. prior notice
  contact

13
What Food is Subject to FDAs Jurisdiction?

• Definition in sec. 201 (f) of the Federal Food,
  Drug, and Cosmetic Act applies
• i.e., (1) articles used for food or drink for
  man or other animals, (2) chewing gum, and (3)
  articles used for components of any such
  article.

14
What Food is Subject to FDAs Jurisdiction (cont)?

• Except the following are not food for purposes
  of the rule
• Food contact substances, as defined in
  409(h)(6) of the FDC Act
• Pesticides regulated by EPA, as defined in 7
  U.S.C. 136(u)

15
Examples of FDA-regulated Food Within Scope of
the Rule

• Dietary supplements and dietary ingredients
• Infant formula
• Beverages (including alcoholic beverages and
  bottled water)
• Fruits and vegetables
• Fish and seafood
• Dairy products and shell eggs

16
Examples of FDA-regulated Food Within Scope of
the Rule (cont.)

• Raw agricultural commodities for use as food or
  components of food
• Canned and frozen foods
• Live food animals
• Bakery goods, snack food, candy, and chewing gum
• Animal feeds and pet food

17
Registration Definitions

• Facility an establishment or structure(s) under
  one ownership at one general physical location
  (or in the case of a mobile facility, traveling
  to multiple locations), that manufactures/processe
  s, packs, or holds food for human or animal
  consumption in the U.S.
• A facility may be one food processing plant
  with multiple buildings in one location

18
Facility Definition(cont.)

• A building that has multiple companies at the
  same address would be considered 2 or more
  facilities
• What is not a facility
• Transport vehicles if they hold food only in the
  usual course of business as carriers
• A private residence of an individual
• Non-bottled drinking water collection and
  distribution establishments

19
What Facilities Are Exempt?

• Non-profit establishments
• Retailers
• Farms
• Restaurants
• Fishing vessels, except those that engage in
  processing as defined in FDAs seafood HACCP
  regulations (21 CFR 123.3(k))
• Facilities regulated exclusively, throughout the
  entire facility, by the U.S. Department of
  Agriculture (USDA)
• Note USDA regulates meat products, poultry
  products, and egg products

20
Additional Exemption for Some Foreign Facilities

• Foreign facilities that manufacture/ process,
  pack, or hold food are exempt if a subsequent
  foreign facility further manufactures/processes
  (including packages) the food, except
• if the subsequent facility performs labeling or
  any similar activity of a de minimis nature, both
  foreign facilities must register

21
Definitions (cont.)

• Farm a facility in one general physical
  location devoted to the growing and harvesting of
  crops for food and/or the raising of animals for
  food (including seafood)
• Washing, trimming outer leaves, and cooling
  produce are considered part of harvesting when
  done on a farm
• E.g., apple orchards, dairy farms, feedlots, and
  aquaculture facilities

22
Farm Definition(cont.)

• Farm includes a facility that . . .
• Packs or holds food if all food is grown or
  raised on that farm or consumed on that farm or
  another farm under the same ownership or
• Manufactures/processes food, if all of the food
  used in such activities is consumed on that farm
  or another farm under the same ownership

23
Mixed-Type Facilities

• If an establishment is a combination of a
  facility subject to the rule and an exempt
  facility, the facility is required to register
• E.g., a farm that grows oranges and manufactures/
  processes the oranges into juice for sale to a
  distributor must register because the
  manufacturing/processing activity is subject to
  the rule

24
Mixed-Type Facilities (cont)

• A facility is exempt from registering only if all
  of its activities are included in one or more
  exemptions
• E.g., a farm that sells the orange juice it
  produces to consumers as its primary function
  would be exempt under the farm exemption and the
  retail exemption

25
What Information is Required?

• Name of facility, full address, phone number
• Same information for the parent company, if the
  facility is a subsidiary
• The name, address, and phone number of the owner,
  operator, or agent in charge
• All trade names the facility uses

26
What Information Is Required?(cont)

• Name of U.S. agent and contact information
  (foreign facilities only)
• Emergency contact phone number (domestic
  facilities only)
• Foreign facilities can opt to include this
  information if they want someone other than their
  U.S. agent to serve as the emergency contact
• Food product categories (21 CFR 170.3)

27
What Information Is Required? (cont)

• A statement that the information submitted is
  true and accurate and that the individual
  submitting the form (if not the owner, operator,
  or agent in charge) is authorized to do so.
• The submitter, if not the owner, operator, or
  agent in charge, also must provide the name and
  contact information of the individual who
  authorized submission of the form

28
Optional Information

• FDA encourages submission of optional information
  to facilitate communications between FDA and
  facility
• Most/all food product category can be used
  instead of individual mandatory food product
  categories all other optional fields are in
  addition to mandatory fields

29
How to Register

• FDA strongly encourages electronic registration
• Available 24 hours/day, 7 days/week worldwide
  where ever Internet is accessible
• Will not allow registration to be submitted until
  all mandatory fields are completed

30
How to Register

• Will provide automatic receipt of registration
  and facilitys registration number
• Internet access publicly available (E.g.,
  libraries, Internet cafes, copy centers)
• Reminder An authorized individual can register
  a foreign facility (E.g., U.S. agent)

31
How to Register (cont.)

• Paper registrations accepted (for example, if
  Internet access not reasonably available)
• Much slower process (FDA estimates we can
  process 1,800 registrations per day)
• Need to ensure form is legible and complete,
  otherwise delays will occur
• FDA will enter the information on the form and
  assign each facility a registration number in the
  order the forms are received

32
Costs and Frequency of Registration

• No registration fee
• Registration is one-time, not annual
• Updates required within 60 days of a change in
  any mandatory information previously submitted to
  FDA
• FDA encourages timely updates of optional
  information previously submitted to assist FDA in
  keeping its database current in order to respond
  to emergencies

33
Cancellation of Registration

• A facility canceling its registration must do so
  within 60 days of the reason for cancellation
• E.g., facility ceases operations, ceases
  providing food for consumption in the U.S., or
  facility is sold to a new owner
• New owner must register facility before beginning
  to manufacture, process, pack or hold food for
  consumption in the U.S.

34
Where to Register, Update or Cancel a Registration

• Electronically http//www.access.fda.gov
• Request a paper copy by mail or phoneU.S. Food
  and Drug Administration (HFS-681)5600 Fishers
  LaneRockville, MD, USA 20857877 332-3882
• Ask for Form 3537 to register or update
• Ask for Form 3537a to cancel a registration

35
(No Transcript)
36
(No Transcript)
37
Prior Notice of Imported FoodInterim Final
Rule68 FR 58974 (Oct. 10, 2003)

• Sec. 307 In the case of an article of food that
  is being imported or offered for import into the
  United States, the Secretary . . . shall by
  regulation require, for the purpose of enabling
  such article to be inspected at ports of entry
  into the U.S. a notice providing the identity of
  the article the manufacturer and shipper of the
  article the grower, if known the country from
  which the article originates the country from
  which the article is shipped and the anticipated
  port of entry.

38
The Current Import Process

• Information
• Filer Importer
• Consignee Manufacturer
• Product HTS code
• Quantity Country of Origin
• Value Carrier information
• Entry type Entry Number
• Arrival date Port of Entry
• . . . and more

39
The Current Import Process

• Information provided to CBP about entry
• electronically through ABI (98)
• by customs broker (filer)
• Same information forwarded to FDA
• electronically to OASIS
• by CBP
• Additional Information for FDA
• FDA Product Code, Affirmations of Compliance,
  FDA Country of Origin, Manufacturer, and Shipper

40
The Current Import Process

• Evaluated by FDA
• electronic screening
• human assessment
• Admissibility decision by FDA
• electronically from FDA to CBP to broker
• Notices (paper) to importer

41
The New Import Process (Prior Notice)

• New Information
• Country from which the article is shipped
• Crossing location within the port of arrival
• Revised Information
• Actual manufacturer
• Registration number
• Manufacturer
• Shipper
• Grower, if known

42
The New Import Process (Prior Notice)

• New Procedures
• Information screened by FDA
• Regardless of source (CBP or PNSI)
• Electronically
• Additional FDA staff assessment
• 24/7
• Centrally located

43
Prior Notice vs. 801(a) Admissibility

• A determination that an article of food is no
  longer subject to hold for a prior notice or
  registration violation
• Is different than, and may come before,
  determinations of admissibility under other
  provisions of the FDC Act or other U.S. laws
• Does not mean that it will be granted admission
  under other provisions of the FDC Act or other
  U.S. laws.

44
Port of Arrival vs. Port of Entry
Crossing Location Port of Arrival for Prior
Notice may or may not be the port where entry is
made for CBP purposes
45
Article of Food vs. Shipment of Food
1 Shipment 4 different products 4 prior notices
46
What Food Imports are Subject to Prior Notice?

• Unless excepted, all food for humans and animals
  that is imported or offered for import into the
  United States for use, storage, or distribution
  in the U.S., including
• Food for gifts and trade
• Quality assurance/quality control samples
• Food for future export

47
What Food Imports are Subject to Prior Notice
(cont)?

• Food for transshipment through the U.S. to
  another country
• Food for use in a U.S. Foreign Trade Zone (FTZ)
• Food sent by mail
• Food sent by express couriers

48
What Definition of Food Applies?

• With some exceptions, the definition in section
  201 (f) of the Federal Food, Drug, and Cosmetic
  Act applies
• i.e., (1) articles used for food or drink for
  man or other animals, (2) chewing gum, and (3)
  articles used for components of any such
  article.

49
What is Excluded from the Prior Notice Food
Definition

• Food contact substances, as defined in
  409(h)(6) of the FDC Act
• Pesticides regulated by EPA, as defined in 7
  U.S.C. 136(u)
• Meat, poultry and egg products that at the time
  of importation are subject to USDAs exclusive
  jurisdiction

50
What Kinds of Food Imports are Not Subject to
Prior Notice?

• Food carried by or otherwise accompanying an
  individual for personal use (i.e., consumption by
  self, family, or friends, not for sale or other
  distribution)
• Food made by an individual at home sent as a
  personal gift (i.e., not for business reasons) to
  an individual in the U.S.
• Food that is imported then exported without
  leaving the port of arrival until export.

51
Who is Authorized to Provide Prior Notice?

• Submitter can be any person with knowledge of
  the required information
• Transmitter is a person who transmits the
  required information to FDA for the submitter

52
How Do I Submit Prior Notice?

• All prior notice information must be in the
  English language using the Latin (Roman)
  alphabet, except
• individual's name, the name of a company, and the
  name of a street may be submitted in a foreign
  language
• Must be submitted electronically through CBPs
  Automated Broker Interface of the Automated
  Commercial System (ABI/ACS), or FDAs PN System
  Interface (PNSI) at http//www.access.fda.gov

53
Submitting Prior Notice (cont.)

• NOTE PNSI submission is required for
• Articles of food imported or offered for import
  by international mail
• Transaction types that cannot be made through
  ABI/ACS
• Articles of food that have been refused for
  inadequate prior notice

54
When Is My Prior Notice Due?

• Except for food arriving by international mail,
  prior notice cannot be submitted more than 5 days
  before arrival
• Arrival by land via road PN must be given no
  less than 2 hours before the food arrives at the
  port of arrival
• Arrival by air and land via rail PN must be
  given no less than 4 hours before the food
  arrives at the port of arrival

55
When Is My Prior Notice Due? (cont.)

• Arrival by water PN must be given no less than
  8 hours before the food arrives at the port of
  arrival
• Food carried by or accompanying an individual
  time is based on manner of transportation
• Food arriving by international mail the prior
  notice must be submitted before the food is mailed

56
What Information is Required in a Prior Notice?

• indicates that if registration number is
  provided, then only city and country are required
  instead of full address
• Submitter (name, address, phone, fax, e-mail)
• Transmitter (name, address, phone, fax, e-mail)
• CBP Entry type (e.g., Consumption entry,
  Warehouse entry, Transportation and Exportation
  entry)
• CBP Entry Identifier (e.g., entry number or
  in-bond number)

57
What Information is Required in a Prior Notice?

• Identity of the article of food
• Complete FDA product code
• Common or usual name or market name
• Estimated Quantity
• Lot or code numbers, if required by FDC Act or
  FDA regulations
• E.g., low acid canned foods, infant formula,
  acidified foods

58
What Information is Required in a Prior Notice?

• indicates not required for an article of food
  imported or offered for import for transshipment,
  storage, and export, or further manipulation and
  export
• For food no longer in its natural state --
  manufacturer and registration number
• Not required for food sent by individual as
  personal gift (provide name and address of firm
  on label)
• For food in its natural state -- grower, if known
• FDA Country of Production

59
What Information is Required in a Prior Notice?

• Shipper and registration number
• Country from which the article is shipped
• Anticipated arrival information
• Port of arrival (and border crossing)
• Date of arrival
• Time of arrival

60
What Information is Required in a Prior Notice?
(cont.)

• Name and address of importer
• Name and address of owner (if different than
  importer or ultimate consignee)
• Name and address of ultimate consignee

61
What Information is Required in a Prior Notice?
(cont.)

• Mode of transportation
• Carrier - Standard Carrier Abbreviation Code
  (SCAC) or International Air Transportation
  Association (IATA) code carrying the food from
  the country from which it is shipped
• HTS (Harmonized Tariff Schedule) code

62
What Information is Required in a Prior Notice?
(cont.)

• Planned shipment information
• All airway bill number or bill of lading
  number, and container number if containerized
  cargo
• Vessel vessel name and voyage number
• Air flight number
• Road trip number
• Rail car number
• Private vehicle license plate number and
  State/province

63
Requirements for Food Arriving by International
Mail

• All information previously listed, except
• Anticipated port, date, and time of arrival
• Importer, owner, or ultimate consignee
• Mode of transport
• Carrier and planned shipment information
• HTS Code
• Additional information required
• Date of shipment
• U.S. recipient

64
What Happens When FDA Accepts Your PN For Review?

• FDA will notify you that your PN has been
  confirmed for review with a reply message
  containing a PN Confirmation Number
• Prior Notice clock (for timeliness of notice)
  starts when FDA confirms PN
• Note receipt of confirmation does not mean that
  FDA has determined the PN is timely or accurate

65
Prior Notice Confirmation Number Must Accompany .
. .

• any article of food arriving by international
  mail number must be on Customs Declaration
• food brought in by individual for non-personal
  use and
• any article of food for which PN was submitted
  through PNSI when the article arrives in the
  U.S. number must be provided to CBP or FDA upon
  arrival

66
What if the Information Changes After I Submit a
Prior Notice?

• If change is to estimated quantity, anticipated
  arrival information, planned shipment information
  or estimated date of mailing no action required
• All other changes must submit new prior notice,
  unless food will not be offered for import into
  the U.S.
• Should also cancel PN previously submitted (PNSI
  or ABI/ACS depending on how PN was filed)
• Timeframe will restart

67
What Happens to Food Without Adequate Prior
Notice?

• No or inaccurate prior notice food is subject
  to refusal
• Untimely prior notice - food is subject to
  refusal, unless FDA has already reviewed the
  notice and notified CBP of its response

68
What Happens to Food Without Adequate Prior
Notice?

• If refused, food must be held at the port of
  entry, unless
• CBP concurrence is obtained for export and food
  immediately exported from the port of arrival
  under CBP supervision or
• Directed to another location by CBP or FDA
• Must notify FDA of hold location
• FDA and CBP are not liable for transportation,
  storage or other expenses resulting from any hold

69
What Happens to Food Without Adequate Prior
Notice?

• Refused food is general order merchandise (19
  U.S.C. 1490) and must be moved under appropriate
  custodial bond
• Refused food must not be entered with CBP it
  must not be delivered to importer, owner, or
  ultimate consignee until prior notice
  requirements met

70
Consequences of Failure to Submit Adequate Prior
Notice

• Prohibited act to import or offer for import food
  without providing prior notice
• FDA can bring a civil or criminal action in
  federal court
• FDA can seek to debar persons under section 306
  of the Bioterrorism Act

71
Consequences of Failure to Register If Required

• If the failure relates to the manufacturer the
  food is subject to refusal for failure to provide
  adequate prior notice
• (Identity of facility is incomplete)
• Same consequences for inadequate prior notice
  apply

72
Consequences of Failure to Register If Required
(cont.)

• If the failure relates to another facility
  associated with the food that is not registered,
  food is subject to hold at the port of entry or
  other location if directed by FDA or CBP
• Food remains under hold until facility is
  registered and number provided to FDA

73
How To Comment(Deadline December 24, 2003)

• Submit written comments on the areas requested in
  the interim final rules to
• Dockets Management Branch (HFA-305)
• Food and Drug Administration
• 5630 Fishers Lane, rm. 1061
• Rockville, MD USA 20852
• Submit electronic comments to
  http//www.fda.gov/dockets/ecomments
• YOU MUST INCLUDE THE DOCKET NUMBER
• 2002N-0276 Registration 2002N-0278 Prior Notice

74
Whom Do I Call?

• Questions regarding the electronic or paper
  registration
• Phone [phone] or 301-575-0156
• Fax [phone]
• E-mail http//www.cfsan.fda.gov/furls/helpf2.ht
  ml
• Hours of operation are Monday-Friday, from 7
  a.m. until 11 p.m., Eastern Time.

75
COMING SOON
76
For Further Information . . .

• For current information on FDAs efforts under
  the Bioterrorism Act or to obtain copies of the
  rules or electronic copies of FDAs overview
  slides
• http//www.fda.gov Click on Bioterrorism