New FDA Rules Implementing the Bioterrorism Act of 2002

1

• New FDA Rules Implementing the Bioterrorism Act
  of 2002
• Overview of Registration and Prior Notice Interim
  Final Rules

2
Purpose of Briefing

• Provide status of development of
• Recordkeeping Final Rule
• Administrative Detention Final Rule
• Provide overviews of
• Registration Interim Final Rule
• Prior Notice Interim Final Rule
• FDAs and CBPs enforcement discretion policy and
  joint implementation plan

3
FDA Lead Personnel

• L. Robert Lake Senior Manager
• [phone] or Lloyd.Lake_at_fda.hhs.gov
• Leslye M. Fraser Regulations Development Lead
• [phone] or Leslye.Fraser_at_fda.hhs.gov
• Louis J. Carson Outreach Lead
• [phone] or Louis.Carson_at_fda.hhs.gov
• Deborah Ralston Prior Notice Implementation
• [phone] or Deborah.Ralston_at_fda.hhs.gov

4
Status of Recordkeeping and Administrative
Detention

• FDA published proposed rules on May 9, 2003 with
  a 60 day comment period
• Establishment and Maintenance of Records (68 FR
  25188)
• Administrative Detention (68 FR 25242)
• FDA evaluating public comments it received
• 200 comments on records 100 comments on
  detention
• Publication goal for final rules May 2004

5
Development of Registration and Prior Notice Rules

• 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 470 comments on Prior Notice
• Oct. 10, 2003 FDA and CBP published interim
  final rules (68 FR 58894, 68 FR 58974)
• Registration System operational Oct. 16, 2003
• Prior Notice Systems operational Dec. 12, 2003

6
Background FDAs Regulatory Development Timeline

• Oct. 28, 2003 Public meeting via satellite
  downlink to domestic and international sites
• Transcripts 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/oc/bioterrorism/bioact.h
  tml
• Dec. 12, 2003 Interim final rules took effect
• Dec. 24, 2003 First comment period on IFR
  closed will reopen in April 2004 for 30 days

7
Background What Is An Interim Final Rule (IFR)?

• An IFR is a final rule that has
• the full force and effect of law
• 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
• The agency will consider timely comments before
  deciding whether to issue a revised final rule or
  confirm the interim final rule as final

8
How Do I Get a Copy of theInterim Final Rules?

• http//www.fda.gov/oc/bioterrorism/bioact.html
• Or write to
• Dockets Management Branch (HFA-305)
• Food and Drug Administration
• 5630 Fishers Lane, Room 1061
• Rockville, MD USA 20852

9
How To Comment (1 of 2)

• NOTE FDA will consider only those comments
  submitted during an open comment period
• Submit written comments to
• Dockets Management Branch (HFA-305)
• Food and Drug Administration
• 5630 Fishers Lane, rm. 1061
• Rockville, MD USA 20852

10
How To Comment(2 of 2)

• Submit electronic comments to
  http//www.fda.gov/dockets/ecomments (no
  attachments) orFDADockets_at_oc.fda.gov (with
  attachments)
• YOU MUST INCLUDE THE DOCKET NUMBER
• 2002N-0276 Registration
• 2002N-0278 Prior Notice

11
Compliance Policy Exercise of Enforcement
Discretion

• Dec. 2003- FDA and CBP issued compliance policy
  guides (CPGs) outlining how it intends to
  exercise enforcement of the IFRs
• Describes agencies strategy for maintaining an
  uninterrupted flow of safe food imports while
  ensuring compliance with the rules
• For first 8 months of implementation, agencies
  will focus on educating affected parties, not
  hard enforcement
• We will continue to take all necessary steps
  including rigorous enforcement action when needed
  -- to safeguard the food supply

12
Compliance Policy (cont.)

• March 13 May 12, 2004
• Civil monetary penalties against violators
  importing food with no prior notice (other than
  food carried by or otherwise accompanying an
  individual or food arriving by international
  mail), if repeat conduct of a similar nature, or
  the violation appears to be intentional or
  flagrant.
• Refusals and CBP penalties may be considered
  when available evidence or information indicates
  threat of serious adverse health consequences or
  death to humans or other animals.
• Full compliance is expected by August 12, 2003.

13

• An Overview of the
• Registration of Food Facilities Interim Final
  Rule
• 68 FR 58894 (Oct. 10, 2003)

14
Bioterrorism Act of 2002Section 305

• The Secretary shall by 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.

15
Overview of Registration Requirements

• Points to Cover
• Who Must Register
• Scope of Rule/Food
• Definitions
• Exemptions
• What Information is Required
• How to Register
• Consequences of Failing to Register

16
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

17
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

18
U.S. Agent

• Foreign facilities are required to have a U.S.
  agent
• 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

19
U.S. Agent (cont.)

• 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
• Having one U.S. agent for registration purposes
  does not preclude a foreign facility from having
  multiple agents for other purposes (E.g., sales)

20
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.

21
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)

22
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

23
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

24
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/processes, 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

25
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

26
Definitions (cont.)

• Manufacturing/processing
• Making a food from one or more ingredients
• Synthesizing, preparing, treating, modifying, or
  manipulating food, including food crops or
  ingredients
• E.g., cutting, peeling, trimming, washing,
  waxing, bottling, labeling, or packaging

27
Definitions (cont.)

• Packaging placing food into a container that
  directly contacts the food that the consumer
  receives, which involves some sort of change to
  or manipulation of the food.
• Packing placing food into a container other
  than packaging the food
• Holding storage of food
• E.g., warehouses, cold storage facilities,
  storage silos, grain elevators, liquid storage
  tanks

28
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))

29
What Facilities Are Exempt?

• 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
• Facilities that only hold food in the usual
  course of business as a carrier (e.g., post
  offices, truck terminals, express courier
  facilities)

30
Definitions (cont.)

• Non-profit establishment
• A charitable entity that prepares or serves food
  directly to the consumer or otherwise provides
  food or meals for consumption by humans or
  animals in the U.S.
• E.g., food banks, soup kitchens, and nonprofit
  food delivery services
• Must meet the terms of section 501 (c)(3) of the
  U.S. Internal Revenue Code

31
Definitions (cont.)

• Retail establishment
• An establishment that sells food products
  directly to consumers as its primary function
• An establishment that manufactures/ processes,
  packs, or holds food if the establishments
  primary function is to sell food, including food
  that it manufactures/ processes, or holds,
  directly to consumers

32
Definitions (cont.)

• Note
• Businesses are not considered consumers
• Primary function is measured by annual sales to
  consumers, which must be greater than annual
  sales to non-consumers

33
Definitions (cont.)

• Restaurant a facility that prepares and sells
  food directly to consumers for immediate
  consumption
• E.g., cafeterias, cafes, fast food establishments
  and hospital, nursing home, or day care kitchens
  and, by analogy, pet shelters, kennels, and
  veterinary facilities that provide food directly
  to animals
• Facilities that provide food to interstate
  conveyances (E.g., trains, planes) are not
  restaurants

34
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

35
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

36
Allowable Farm Activities(If facility otherwise
meets the farm definition)

• Applying pesticides on a farm to pre-harvested
  crops
• Use of chlorinated water to wash crops depends
  on source and level of chlorine
• Placing stickers on fruit
• Placing a raw agricultural commodity directly
  into consumer-ready packages

37
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

38
Foreign FacilitiesRegister or Exempt?

• Register
• Manufacturing/processing a finished food product
• Packing or holding a food product or food
  ingredient
• Exempt
• Manufacturing/processing a food ingredient that
  is subsequently further manufactured/processed
  outside the U.S.

39
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

40
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

41
Two Types of Information Mandatory and Optional

• All mandatory fields in a registration must be
  completed, except
• Facilities that select most/all for food
  product categories do not have to identify
  individual categories on the registration
• FDA encourages submission of optional information
  to assist with communications with the facility

42
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

43
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)

44
What Information Is Required? (cont)

• 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

45
What Information is Optional?

• Fax number and e-mail address of the facility
• Preferred mailing address
• Type of activity (E.g., manufacturer/ processor)
• Title, fax number, and e-mail address of the U.S.
  agent
• Type of storage

46
What Information is Optional?

• Additional food product categories not specified
  in 21 CFR 170.3
• E.g., dietary supplements, infant formula, animal
  feed
• Most/all food product category (instead of
  mandatory food product categories)
• Approximate dates of operation, if seasonal

47
What Information is Optional?

• Fax number and e-mail address of the owner,
  operator, or agent in charge
• Fax number and email address of the owner,
  operator, or agent in charge
• For domestic facilities
• Fax email address of the parent company
• Emergency contact name, title, and e-mail address
• For foreign facilities
• Emergency contact name, title, phone number, and
  e-mail address

48
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

49
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)

50
How to Register (cont.)

• Paper registrations accepted (for example, if
  Internet access not reasonably available)
• Much slower process
• 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

51
Costs and Frequency of Registration

• No registration fee
• Registration is one-time, not annual

52
What if Changes Occur?

• 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

53
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

54
Cancellation of Registration (cont)

• Cancellation may be done electronically or by
  mail and must include
• Facilitys registration number
• Whether facility is domestic or foreign
• Facility name and address
• Name and address of the individual submitting the
  cancellation
• Statement certifying information is true and
  accurate and person is authorized to submit
  cancellation

55
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

56
Confidentiality of Registration Information

• The Bioterrorism Act precludes FDA from publicly
  disclosing registration numbers and related
  registration information.
• Facilities are not precluded from sharing their
  registration numbers with third parties, but are
  urged to treat them as sensitive business
  information.
• In some instances, a facility will need to
  provide its registration number to persons who
  may be submitting prior notice for a product
  manufactured by the facility.

57
Registered Facilities

• FDA estimated 420,000 facilities worldwide need
  to register
• As of March 30, 2004
• Domestic (U.S.) registrations 95,091
• Foreign registrations 100,838
• Total 195,929

58
What Are the Consequences of Failing to Register,
if Required?

• Failure to register, update, or cancel a
  registration as required is a prohibited act
• FDA can bring a civil or criminal action

59
Consequences of Failure to Register If Required
(cont)

• If the failure relates to a foreign manufacturer,
  the food is subject to refusal for failure to
  provide adequate prior notice (identity of
  facility is incomplete)
• Note Registration for foreign facilities will
  be enforced through prior notice (will be
  discussed later in more detail)

60
Questions on the Registration Interim Final Rule
???
61
Intermission!

• This session will resume shortly, please join us
  again then!

62

• An Overview of the
• Prior Notice of Imported Food
• Interim Final Rule
• 68 FR 58974 (Oct. 10, 2003)

63
Bioterrorism Act of 2002Section 307

• For an article food imported or offered for
  import into the U.S, the Secretary shall require
  the submission of prior notice providing the
  identity of the following
• The article
• Manufacturer and shipper of the article
• The grower, if known
• Country of origin
• Country from which the article is shipped
• Anticipated port of entry

64
Overview of Prior Notice Requirements

• Points to Cover
• The Current Import Process
• The New Process (Prior Notice)
• Definitions
• Exemptions
• How to Submit Prior Notice
• What Information is Required
• Consequences of Inadequate Prior Notice

65
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

66
The Current Import Process

• Information provided to CBP about entry
• electronically through ABI (gt98)
• 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

67
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

68
The Current Import Process

• WHEN
• Maximum prior time set by CBP according to mode
  of transportation
• CBP (and FDA) screening response
• no more than 5 days before arrival if by sea
• no sooner than wheels-up if by air
• at arrival if by land

69
PRIOR NOTICE OF IMPORTED FOOD

• THE NEW IMPORT PROCESS
• beginning Dec. 12, 2003

70
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

71
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

72
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 the food will be granted
  admission under other provisions of the FDC Act
  or other U.S. laws.

73
Prior Notice vs. 801(a) Admissibility (cont.)

• If not examined at border under prior notice
• Food still may be examined or sampled at an
  inland location or importers premises or public
  storage
• Routine notices follow decision to examine or
  sample
• NOTE Most holds on food to date are not for
  prior notice they are routine sampling or
  inspection holds

74
FDAS Prior NoticeDefinitions

• International Mail foreign national mail
  services
• Does not include express carriers, express
  consignment operators, or other private delivery
  services
• Port of Arrival water, air, or land port at
  which the article of food is imported or offered
  for import into the U.S. (i.e., the port where
  the article of food first arrives in the U.S.)
• Note May be different from the port where food
  is entered for CBP purposes

75
FDA Country of Production(Originating Country)

• For food in its natural state -- the country
  where the article of food was grown or collected,
  including harvested and readied for shipment to
  the U.S.
• For wild fish or seafood caught or harvested
  outside the waters of the U.S. by a vessel that
  is not registered in the U.S. the country in
  which the vessel is registered
• For an article of food that was grown in a U.S.
  Territory the U.S.

76
FDA Country of Production vs. CBP Country of
Origin

• The Bean Example beans are grown and dried in
  the U.S., then rehydrated and canned in Country D
• CBP identifies the country of origin as the U.S.
• For purposes of prior notice, FDA identifies the
  article of food as canned beans, not dried
  beans
• Thus, FDA Country of Production is Country D

77
FDAS Prior Notice Definitions

• Shipper the owner or exporter of the article of
  food who consigns and ships the article from a
  foreign country or the person who sends an
  article of food by international mail to the U.S.
• United States the Customs territory of the
  United States (i.e., the 50 States, the District
  of Columbia, and the Commonwealth of Puerto Rico,
  but not the Territories)

78
Article of Food vs. Shipment of Food
Tuna 24/12 oz cans 2000 cases Company 1
Tuna 48/6 oz cans 1000 cases Company 1
Tuna 24/12 oz cans 300 cases Company 2
Tuna 6/66oz cans 2400 cases Company 3
1 Shipment 4 different products 4 prior notices
79
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

80
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

81
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.

82
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

83
Examples of FDA-regulated Food Within Scope of
the Rule

• 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

84
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

85
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.

86
What Kinds of Food Imports are Not Subject to
Prior Notice?

• Food that is imported then exported without
  leaving the port of arrival until export
• Food brought into the U.S. in a diplomatic pouch

87
Comparison of Food for Registration and Prior
Notice

• Registration requirements only apply if food
  will be consumed in the U.S. by humans or animals
• Prior Notice requirements applies to all food
  that is imported or offered for imported into the
  U.S. regardless of whether it will be consumed in
  the U.S.
• Both rules quantity is not a factor (e.g., both
  rules apply to samples if above criteria are met)

88
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

89
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

90
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

91
Submitting Prior Notice (cont.)
If this isnt working . . . Then file here In this form
Customs brokers or self-filers system, or ABI/ACS FDA PNSI Electronically
PNSI (FDA will post notice at http//www.access.fda.gov) FDA (see http//www.fda.gov see Prior Notice for locations) Via e-mail or fax (unless using ABI/ACS)
92
Submitting Prior Notice (cont.)
If this isnt working . . . Then file here In this form
OASIS (FDA will post notice at http//www.access.fda.gov and messages in ABI/ACS) FDA (see http//www.fda.gov see Prior Notice for locations) Via e-mail or fax
Note PN will only be accepted by e-mail or
faxif FDA determines PNSI or OASIS is not working
93
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

94
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

95
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)

96
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

97
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

98
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

99
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

100
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

101
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

102
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

103
Requirements for Food Refused for Inadequate
Prior Notice

• All information previously listed, except
• Anticipated port, date, and time of arrival
• Additional information required
• U.S. recipient
• Hold location

104
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

105
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

106
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

107
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

108
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

109
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

110
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 304
  of the Bioterrorism Act

111
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

112
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

113
FDA-CBP JointImplementation Plan

• Published in April 2004 plan includes a
  schedule for coordinating timeframes for
  implementing FDAs prior notice information and
  CBPs advanced electronic information (69 FR
  68140, Dec. 5, 2003)
• CBP advance notice timeframes
• 1 hour before arrival by land by road, or 30
  minutes for participants in FAST/C-TPAT
• 2 hours before arrival by land by rail and
• By wheels up for flights originating in North
  and Central America, South America (north of the
  Equator only), the Caribbean, and Bermuda
  otherwise 4 hours before arrival by air

114
Compliance Status

• FDA and CBP have posted on their websites
  summaries of compliance statistics
• Complete prior notice does not mean prior
  notice data elements are accurate
• Enforcement discretion period not monitoring

115
ACS Submission By Source
Blue Products with complete data Yellow
Products with incomplete data Green Products
with no prior notice data
116
Percent of Information Complete
117
Percent Complete by Mode of Transportation (ACS)
118
Percent Complete by Mode of Transportation (PNSI)
119
For Further Information . . .

• For current information on FDAs efforts under
  the Bioterrorism Act
• http//www.fda.gov/oc/bioterrorism/bioact.html

120
Questions Regarding Does The Rule Apply to My
Activity?

• To date, FDA has received over 100,000 inquiries,
  more than 2/3 of which are questions of
  applicability
• Please read the rules first many questions are
  answered there
• Next, please see our website for Question and
  Answer (QA) documents in which we respond to
  new questions http//www.cfsan.fda.gov/dms/gui
  dance.html

121
Questions Regarding Does A Rule Apply to What I
Do?

• If your question is not answered in any of the
  above, please send it to us
• Phone [phone] or 301-575-0156
• Fax [phone]
• E-mail furls_at_fda.gov
• Please note, given the volume of questions we
  receive
• You generally will not receive an individual
  response
• We will answer new questions in a future QA
  Document

122
Technical Assistance Questions

• Questions regarding how to access the electronic
  or paper registration
• Phone [phone] or 301-575-0156
• Fax [phone]
• E-mail furls_at_fda.gov
• Hours of operation are Monday-Friday, from 7
  a.m. until 11 p.m., Eastern Time.
• Questions regarding prior notice system issues
  Deborah Ralston [phone] or
  Deborah.Ralston_at_fda.hhs.gov

123
(No Transcript)