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

2. 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 – FDA’s and CBP’s enforcement discretion policy and joint implementation plan

3. 3 FDA Lead Personnel L. Robert Lake – Senior Manager – (301) 436-2379 or Lloyd.Lake@fda.hhs.govLloyd.Lake@fda.hhs.gov Leslye M. Fraser – Regulations Development Lead – (301) 436-2378 or Leslye.Fraser@fda.hhs.govLeslye.Fraser@fda.hhs.gov Louis J. Carson – Outreach Lead – (301) 436-2130 or Louis.Carson@fda.hhs.govLouis.Carson@fda.hhs.gov Deborah Ralston – Prior Notice Implementation – (301) 443-6230 or Deborah.Ralston@fda.hhs.govDeborah.Ralston@fda.hhs.gov

4. 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. 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. 6 Background: FDA’s 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 FDA’s website in Arabic, Chinese, French, Hindi, Japanese, Malay, Portuguese, and Spanish: http://www.fda.gov/oc/bioterrorism/bioact.html http://www.fda.gov/oc/bioterrorism/bioact.html http://www.fda.gov/oc/bioterrorism/bioact.html Dec. 12, 2003: Interim final rules took effect 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. 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. 8 How Do I Get a Copy of the Interim Final Rules? http://www.fda.gov/oc/bioterrorism/bioact.html Or write to:Or write to: Dockets Management Branch Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD USA 20852

9. 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. 10 How To Comment (2 of 2) Submit electronic comments to: http://www.fda.gov/dockets/ecomments (no attachments); or FDADockets@oc.fda.gov (with attachments) http://www.fda.gov/dockets/ecomments FDADockets@oc.fda.gov YOU MUST INCLUDE THE DOCKET NUMBER: 2002N-0276 Registration 2002N-0278 Prior Notice

11. 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. 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. 14 Bioterrorism Act of 2002 Section 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. 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. 16 Who Must Register? Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food (subject to FDA’s jurisdiction) for human or animal consumption in the U.S. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food (subject to FDA’s 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. 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. 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. 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. 20 What Food is Subject to FDA’s 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. 21 What Food is Subject to FDA’s Jurisdiction (cont)? Except the following are not “food” for purposes of the rule: – Food contact substances, as defined in § 409(h)(6) of the FD&C Act – Pesticides regulated by EPA, as defined in 7 U.S.C. § 136(u)

22. 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. 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. 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. 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. 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. 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. 28 What Facilities Are Exempt? Non-profit establishments Retailers Farms Restaurants Fishing vessels, except those that engage in processing as defined in FDA’s seafood HACCP regulations (21 CFR 123.3(k))

29. 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. 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. 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 establishment’s primary function is to sell food, including food that it manufactures/ processes, or holds, directly to consumers

32. 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. 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. 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. 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. 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. 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. 38 Foreign Facilities— Register 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. 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. 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. 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. 42 What Information is Required? What Information is Required? Name of facility, full address, phone number Name of facility, full address, phone number Same information for the parent company, if the facility is a subsidiary 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 The name, address, and phone number of the owner, operator, or agent in charge All trade names the facility uses All trade names the facility uses

43. 43 What Information Is Required? (cont) Name of U.S. agent and contact information (foreign facilities only) Name of U.S. agent and contact information (foreign facilities only) Emergency contact phone number (domestic 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) Food product categories (21 CFR 170.3)

44. 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. 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. 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. 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. 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. 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. 49 How to Register – Will provide automatic receipt of registration and facility’s 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. 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. 51 Costs and Frequency of Registration No registration fee Registration is one-time, not annual

52. 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. 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. 54 Cancellation of Registration (cont) Cancellation may be done electronically or by mail and must include : – Facility’s 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. 55 Where to Register, Update or Cancel a Registration Electronically: http://www.access.fda.gov Electronically: http://www.access.fda.govhttp://www.access.fda.gov Request a paper copy by mail or phone: U.S. Food and Drug Administration (HFS-681) 5600 Fishers Lane Rockville, MD, USA 20857 877 332-3882 Request a paper copy by mail or phone: U.S. Food and Drug Administration (HFS-681) 5600 Fishers Lane Rockville, MD, USA 20857 877 332-3882 – Ask for Form 3537 to register or update – Ask for Form 3537a to cancel a registration

56. 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. 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. 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. 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. 60 Questions on the Registration Interim Final Rule ???

61. 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. 63 Bioterrorism Act of 2002 Section 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. 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. 65 The Current Import Process Information: FilerImporter Consignee Manufacturer ProductHTS code QuantityCountry of Origin ValueCarrier information Entry typeEntry Number Arrival datePort of Entry... and more

66. 66 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

67. 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. 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. 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. 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. 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 FD&C Act or other U.S. laws – Does not mean that the food will be granted admission under other provisions of the FD&C Act or other U.S. laws.

73. 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 importer’s 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. 74 FDA’S Prior Notice: Definitions 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. 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. 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. 77 FDA’S Prior Notice: Definitions Shipper – t he 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. 78 “Article of Food” vs. Shipment of Food* Tuna24/12 oz cans2000 cases Company 1 Tuna48/6 oz cans1000 cases Company 1 Tuna24/12 oz cans300 cases Company 2 Tuna6/66oz cans2400 cases Company 3 *1 Shipment; 4 different products; 4 prior notices

79. 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. 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. 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. 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. 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. 84 What is Excluded from the Prior Notice Food Definition Food contact substances, as defined in § 409(h)(6) of the FD&C 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 USDA’s exclusive jurisdiction

85. 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. 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. 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. 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. 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 CBP’s Automated Broker Interface of the Automated Commercial System (ABI/ACS), or FDA’s PN System Interface (PNSI) at http://www.access.fda.gov http://www.access.fda.gov

90. 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. 91 Submitting Prior Notice (cont.) If this isn’t working... Then file hereIn this form: Customs broker’s or self-filer’s system, or ABI/ACS FDA PNSIElectronically PNSI (FDA will post notice at http://www.access.fd a.gov) http://www.access.fd a.gov FDA (see http://www.fda.gov – see Prior Notice for locations) http://www.fda.gov Via e-mail or fax (unless using ABI/ACS)

92. 92 Submitting Prior Notice (cont.) If this isn’t working... Then file hereIn this form: OASIS (FDA will post notice at http://www.access.fd a.gov and messages in ABI/ACS) http://www.access.fd a.gov FDA (see http://www.fda.gov – see Prior Notice for locations) http://www.fda.gov Via e-mail or fax Note: PN will only be accepted by e-mail or fax if FDA determines PNSI or OASIS is not working

93. 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. 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. 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. 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 FD&C Act or FDA regulations E.g., low acid canned foods, infant formula, acidified foods

97. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 113 FDA-CBP Joint Implementation Plan Published in April 2004: plan includes a schedule for coordinating timeframes for implementing FDA’s prior notice information and CBP’s 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. 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. 115 ACS Submission By Source Blue: Products with “complete” data Yellow: Products with incomplete data Green: Products with no prior notice data

116. 116 Percent of Information Complete

117. 117 Percent Complete by Mode of Transportation (ACS)

118. 118 Percent Complete by Mode of Transportation (PNSI)

119. 119 For Further Information... For current information on FDA’s efforts under the Bioterrorism Act For current information on FDA’s efforts under the Bioterrorism Act http://www.fda.gov/oc/bioterrorism/bioact.html http://www.fda.gov/oc/bioterrorism/bioact.html

120. 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 (Q&A) documents in which we respond to new questions: http://www.cfsan.fda.gov/~dms/guidance.html http://www.cfsan.fda.gov/~dms/guidance.html

121. 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: 800-216-7331 or 301-575-0156 – Fax: 301-210-0247 – E-mail: furls@fda.govfurls@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 Q&A Document

122. 122 Technical Assistance Questions Questions regarding how to access the electronic or paper registration: – Phone: 800-216-7331 or 301-575-0156 – Fax: 301-210-0247 – E-mail: furls@fda.govfurls@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 – (301) 443-6230 or Deborah.Ralston@fda.hhs.gov Deborah.Ralston@fda.hhs.gov

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