Overview of Registration and Prior Notice Interim Final Rules Implementing the Bioterrorism Act November 21, 2003 Loui

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: FDA�s 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: FDA�s 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 FDA�s website in Arabic , Chinese, French, Hindi, Japanese, Malay, Portuguese, and Spanish: http://www.fda.gov Click on �Bioterrorism�

4. Background: FDA�s 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: FDA�s 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? Question 2.Question 2.

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 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.� 

14. 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)

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/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

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 FDA�s 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?  Question 12 (first slide).Question 12 (first slide).

26. What Information Is Required?(cont) Question 12 (second slide). Question 12 (second slide).

27. What Information Is Required? (cont) Question 12 (third slide). Question 12 (third slide).

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 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)

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 phone:U.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

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

44. Port of Arrival vs. Port of Entry Question 20.Question 20.

45. �Article of Food� vs. Shipment of Food*

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 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

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 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

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) Question 8.Question 8.

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 FD&C Act or FDA regulations E.g., low acid canned foods, infant formula, acidified foods Question 8.Question 8.

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 Question 8.Question 8.

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 Question 8.Question 8.

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: 800-216-7331 or 301-575-0156 Fax: 301-210-0247 E-mail: http://www.cfsan.fda.gov/~furls/helpf2.html Hours of operation are Monday-Friday, from 7 a.m. until 11 p.m., Eastern Time.

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76. For Further Information . . . For current information on FDA�s efforts under the Bioterrorism Act or to obtain copies of the rules or electronic copies of FDA�s overview slides: http://www.fda.gov Click on �Bioterrorism�