1. Overview of Records and Administrative Detention Proposed Regulations Implementing the Bioterrorism Act Leslye M. Fraser, Esq. Associate Director for Regulations Center for Food Safety and Applied Nutrition

2. Purpose of Briefing Provide an overview of proposed regulations implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“the Bioterrorism Act”) (PL 107-188): – Section 306: Establishment, Maintenance, and Availability of Records – Section 303: Administrative Detention of Food for Human or Animal Consumption

3. FDA Regulatory Development: Lead Personnel E-mail: Lloyd.Lake@cfsan.fda.gov Leslye.Fraser@cfsan.fda.gov Nega.Beru@cfsan.fda.gov Marquite.Steadman@cfsan.fda.gov Senior ManagerL. Robert Lake(301) 436-2379 Overall LeadLeslye M. Fraser(301) 436-2378 Records LeadNega Beru(301) 436-1400 Administrative Detention Lead Marquita Steadman(301) 827-6733

4. Background: FDA’s Regulatory Development Timeline July – Aug. 2002: FDA held six outreach meetings with 36 Embassies and 52 organizations Until Aug. 30, 2002: FDA received > 150 comments from stakeholders that we considered as we developed the proposed rules

5. Background: FDA’s Regulatory Development Timeline May 9, 2003: FDA published proposed rules with 60 day comment period (ends July 8, 2003) – No extensions will be granted given statutory deadline May 7, 2003: Public meeting via satellite downlink to domestic and international sites – Transcripts available in English, French & Spanish By Dec. 12, 2003: FDA plans to issue final rules

6. Proposed Recordkeeping Requirements 68 FR 25188 (May 9, 2003) Statutory Deadline: December 12, 2003

7. Who Would Be Required To Establish And Maintain Records? Domestic persons that manufacture, process, pack, transport, distribute, receive, hold or import food intended for human or animal consumption in the U. S. Domestic persons that manufacture, process, pack, transport, distribute, receive, hold or import food intended for human or animal consumption in the U. S. Persons includes Persons includes individuals, partnerships, corporations, cooperatives, associations, and government entities. Foreign facilities that manufacture, process, pack or hold food intended for human or animal consumption in the U.S., unless excluded Foreign facilities that manufacture, process, pack or hold food intended for human or animal consumption in the U.S., unless excluded

8. Excluded From All Requirements: Farms Restaurants Firms regulated exclusively by the US Department of Agriculture (USDA) Whom Does The Proposed Rule Exclude?

9. Excluded From All Requirements: Foreign facilities, if food is further manufactured/processed (including packaging) by another facility outside the US Exclusion does not apply if the activities of the subsequent facility are limited to a de minimis activity Whom Does The Proposed Rule Exclude?

10. Partial Exclusions* Fishing vessels not engaged in processing Pet food entities that are exempt from FDA ’ s BSE rule (21 CFR 589.2000) * No exclusion from the records access provisions Whom Does The Proposed Rule Exclude?

11. Partial Exclusions for Retail* All retail facilities are excluded from keeping records of immediate subsequent recipients Retail facilities employing < 10 full time equivalent employees selling unprocessed food from its farm or a neighboring farm (with respect to records for that unprocessed food) *No exclusion from records access provisions Whom Does The Proposed Rule Exclude?

12. Facilities Engaged in Multiple Activities Records must be established and maintained for all covered activities Example: growing oranges and processing them into orange juice for sale to a distributor – Growing—excluded as farm – Processing—records required

13. What Foods Does the Proposed Rule Cover? Applies to all foods under 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. Examples of FDA-Regulated Food – Food and food additives for man or animals – Dietary supplements and dietary ingredients – Infant formula – Pet food – Beverages (including alcoholic beverages and bottled water) – Fruits and vegetables

15. Examples of FDA-Regulated Food – Fish and seafood – Dairy products and shell eggs – Raw agricultural commodities for use as food or components of food – Canned foods – Live food animals – Bakery goods, snack food, and candy

16. What Foods Does FDA Not Regulate? Foods that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the: – Federal Meat Inspection Act (21U.S.C. 601 et seq.) – Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or – Egg Products Inspection Act (21 U.S.C. 1031 et seq.)

17. Proposed Definitions Farm: a facility in one general physical location devoted to the growing of crops for food and/or the raising of animals for food (including seafood) – e.g., apple orchards, dairy farms, feedlots, and aquaculture facilities

18. Proposed 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; and Manufactures/processes food, if all of the food used in such activities is consumed on that farm or another farm under the same ownership

19. Proposed 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

20. Proposed Definitions (cont.) Pet food – food for non-food producing animals Perishable food - food that is not heat-treated, not frozen, and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 days under normal shipping and storage conditions

21. Proposed Definitions (cont.) Restaurant – a facility that prepares and sells food directly to consumers for immediate consumption – e.g., cafeterias, 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

22. Proposed Definitions (cont.) Retail facility: A facility that sells food products directly to consumers only Transporter - person who has possession, custody, or control of an article of food for the sole purpose of transporting the food Non-transporter - a person who owns food or who holds, processes, packs, imports, receives, or distributes food for purposes other than transportation

23. Records Non-transporters Have To Establish And Maintain to Identify the Immediate Previous Source (IPS) Non-transporters have to establish and maintain records to identify the non-transporter and transporter IPS of all food you receive that include: Firm name, including responsible individual and contact information (domestic or foreign) Description of type of food received, including brand name and specific variety

24. Records Non-transporters Have To Establish And Maintain to Identify the IPS (cont) Date food was received Lot number or other identifier, if available Quantity and how the food is packaged (e.g., 25 lb cartons) Name, responsible individual, and contact information of the transporters who brought the food to you

25. Non-transporters ’ Records Regarding the IPS Records must include all information reasonably available to you to identify the specific source of each ingredient that was used to make every lot of finished product – What is reasonably available may vary from case to case

26. Example 1: Common Storage Silo for An Ingredient (e.g., Flour) Information reasonably available is the identity of all potential sources of the flour for each finished product Source A Source B Source C Common Storage Silo Manufacturing Plant Cookies

27. Example 2: Dedicated Storage Silos for Each Ingredient Source Information reasonably available is the identity of the specific source of the flour for each finished product Source A Source B Source C Manufacturing Plant Cookies

28. Records Non-transporters Have To Establish And Maintain to Identify the Immediate Subsequent Recipient (ISR) Non-transporters have to establish and maintain records to identify the non-transporter and transporter ISR of all food you release that include: Firm name, including responsible individual and contact information of ISR (domestic or foreign) Description of type of food released, including brand name and specific variety

29. What Information Must Non-Transporters Keep in Records to Identify the ISR (cont)? Date food was released Lot number or other identifier, if available Quantity and how the food is packaged (e.g., 25 lb cartons) Name, responsible individual, and contact information of the transporters who transferred the food from you

30. Establishment and Maintenance of Records by Non-Transporters Non-transporters (e.g. manufacturers) must establish and maintain records that identify both the transporter and non-transporter IPS and ISR (indicated with solid red arrows above) Company A Company B Company C Manufacturer Retail Store

31. Records Transporters Have To Establish And Maintain to Identify the IPR and ISR For each food you transport... Firm name, including responsible individual and contact information (domestic or foreign) of: – Person who had the food immediately before you; and – Person who had the food immediately after you Description of type of food, including brand name and specific variety

32. What Records Would Transporters Have To Establish And Maintain? Dates food was received and delivered Lot number or other identifier, if available Quantity and how the food is packaged (e.g., 25 lb cartons) Identification of each and every mode of transportation and responsible individual(s) throughout transport

33. Example 3: Various Transportation Companies Trucks and planes are owned by different companies. The proposed rule would require each company to keep records only of transactions to which it is a party (i.e., from whom it received the food and to whom it released the food). Company A Company B Company C Manufacturer Retail Store

34. Example 4: Purple Transportation Company All trucks and planes are owned by Company A (Purple Transportation Co.) The proposed rule would require the company to keep records of when the food was put on each vehicle and who was responsible for the food during each leg of the trip. Manufacturer Retail Store

35. Frequently Asked Questions...

36. Do other recordkeeping requirements in statutes and regulations still apply? Yes - you still must comply with all other statutes and regulations that apply to you E.g., recordkeeping requirements for infant formula, low acid canned food, animal feed, bottled water, color additives

37. When do I have to create the records? Records must be created at the time the activity occurs

38. Can I Use Existing Records? Yes – if they contain all the information required by the proposed rule You are responsible for supplementing existing records, if necessary, to ensure all required information is established and maintained

39. In what format must I establish and maintain these records? In any format, paper or electronic Must contain all the required information Proposed rule exempts records from 21 CFR Part 11, which specifies criteria for acceptance by FDA of certain electronic records NOTE: No exemption if the records are kept for some other statutory or regulatory purpose

40. How long must the records be retained? 1 Year from date of creation: – Perishable foods not intended for processing into non-perishable foods – All required records for animal food, including pet food 2 years from date of creation: – All other foods, except animal foods

41. What are the record availability requirements? When FDA has reasonable belief that a food is adulterated and presents a threat of serious adverse health consequences of death to humans or animals, records accessible to FDA must be available for inspection and copying by FDA: – Within 4 hours if requested between 8:00 am and 6:00 pm, Monday-Friday – Within 8 hours if requested any other time

42. What are the record availability requirements (cont.)? If records stored offsite, you must be able to retrieve and provide them onsite within specified timeframes Electronic records are considered onsite if they can be retrieved from an onsite location

43. What records are excluded? Recipes (quantitative formula excluded, but not individual ingredients) Financial data Pricing data Personnel data Research data Sales data (other than shipment data regarding sales)

44. What if records aren’t established, maintained, or provided to FDA upon request? Failure to establish and maintain the required records is a prohibited act Failure to make them available to FDA upon proper request is a prohibited act

45. When would compliance with the recordkeeping rules be required? After the final rule is published: – Larger businesses (> 500 full time equivalent (FTE) employees) - within 6 months – Small businesses (11-499 FTE employees) - within 12 months – Very small businesses (< 10 FTE employees) - within 18 months

46. Some Significant Areas For Which FDA Specifically Is Seeking Comment Statutory ambiguity/FDA interpretation that we are required by the Statute to promulgate regulations Intrastate coverage authority Limiting foreign coverage to those subject to Registration rule Outer food packaging exclusion Fishing vessels not engaged in processing exclusion Retail facility/Roadside stand exclusion

47. Some Significant Areas For Which FDA Specifically Is Seeking Comment (cont.) Perishable food definition and record retention criteria Pet food partial exclusion Criteria for determining scope of pet food coverage Non-transporter requirement to keep records on both transporters and non-transporters Inclusion of a Model Form in the final rule

48. Proposed Administrative Detention Requirements 68 FR 25242 (May 9, 2003) Statutory Deadline: None FDA Publication Goal: December 12, 2003

49. What are the criteria for detaining food? An officer or qualified employee of FDA may order detention of food if credible evidence or information that the food presents a threat of serious adverse health consequence or death to humans or animals (SAHCODHA) Applies to both domestic and imported foods

50. Administrative Detention Detention must be approved at district director level or higher, as designated by the Secretary Detention period < 20 days, unless Secretary needs more time (< 30 days total) to pursue seizure or injunction FDA can direct the movement of the food to a secure facility, as appropriate Prohibited act to transfer an article in violation of a detention order or remove/alter any required mark or label

51. 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.” Examples of FDA-regulated food: – Food and food additives for man or animals – Dietary supplements and dietary ingredients – Infant formula – Pet food

52. Examples of FDA-Regulated Food – Beverages (including alcoholic beverages and bottled water) – Fruits and vegetables – Fish and seafood – Dairy products and shell eggs – Raw agricultural commodities for use as food or components of food – Canned foods – Live food animals – Bakery goods, snack food, and candy

53. What Food is Not Subject to Administrative Detention? Foods that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the: – Federal Meat Inspection Act (21U.S.C. 601 et seq.) – Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or – Egg Products Inspection Act (21 U.S.C. 1031 et seq.)

54. Labeling or Marking of Detained Food Detention may require marking or labeling of detained food, which would include: – Statement food is detained by FDA – Statement food must not be consumed, moved, altered, or tampered with in any manner without written permission from FDA – Violation of detention order or removal of tag or label is a prohibited act – Detention order number, detention period, and name of FDA official who issued the order

55. Proposed Expedited Procedures for Detained Perishable Foods If FDA initiates a seizure action against a detained perishable food, FDA will: – send the seizure recommendation to the U.S. Department of Justice (DOJ) < 4 calendar days after detention order issued, unless extenuating circumstances* exist *Includes, but not limited to instances when the results of confirmatory testing or other evidential development requires > 4 working days to complete

56. Proposed Expedited Procedures for Detained Perishable Foods (cont.) – If 4 th calendar day is not a working day, FDA will advise DOJ on last working day before the 4 th day of our plans to recommend seizure action and send recommendation as soon as possible on first working day that follows

57. FDA’S Administrative Detention: Proposed Definitions Perishable foods –Food that is not heat-treated, not frozen, and not otherwise preserved in a manner as to prevent the quality of the food from being adversely affected if held longer than 7 days under normal shipping and storage conditions Calendar Day – every day shown on the calendar

58. What Information Must Be Included in An Administrative Detention Order? Detention order number The date and hour of the order Identification of the detained food The detention period A statement that the article of food identified in the order is detained for the period shown

59. What Information Must Be Included in An Administrative Detention Order (cont.)? A brief, general statement of the reasons for the detention The address and location where the article of food is to be detained and appropriate storage conditions Any applicable conditions of transportation Statement that the food is not to be consumed, moved, altered, or tampered with in any manner during the detention period (unless subject to a conditional release)

60. What Information Must Be Included in An Administrative Detention Order (cont.)? Information regarding the appeal process Name and contact information of the District Director in whose district the food is located Statement indicating how the approval of the detention order was obtained (orally or in writing)

61. Who would receive a copy of the detention order? Owner, operator or agent in charge of the place where the detained food is located Owner* of the food if different from those listed above Shipper of record* and owner and operator of the vehicle/carrier*, if detained food is located in a vehicle or other carrier * If identities can be readily determined

62. When does a detention order terminate? FDA authorized representative will issue a detention termination notice if FDA terminates a detention order or the detention period expires Detention order deemed terminated if FDA fails to issue a detention termination notice or detention period expires

63. Administrative Detention Right to Appeal BT Act requires Secretary, after an opportunity for informal hearing, to decide appeals in 5 days – Appeal decision is subject to judicial review – process terminates if Secretary files for seizure or injunction – detention order terminates if Secretary does not comply with appeal requirements

64. Appeals Any person who would be a claimant for the food, if seized under section 304(a) of the Act, can appeal a detention order Request of an appeal with or without an informal hearing must be addressed to the FDA District Director in whose district the food is located FDA Regional Food and Drug directors or officials senior to them preside at hearings, who may require hearing to be completed within 1 day Presiding officer will issue final agency decision

65. Detention Appeal Timelines Non-perishable Articles of Food Perishable Articles of Food File intent to appeal with a request for an informal hearing within 4 days of receipt of detention order not applicable File appeal with request for an informal hearing within 10 days of receipt of detention order within 2 days of receipt of detention order File appeal without a request for an informal hearing within 10 days of receipt of detention order within 2 days of receipt of detention order

66. Detention Appeal Timelines (cont.) Non-perishable Articles of Food Perishable Articles of Food Hold hearing (FDA)within 3 days after an appeal is filed within 2 days after an appeal is filed Make decision on appeal (FDA) within 5 calendar days after an appeal is filed

67. Use of Classified Information in Hearings Some credible evidence or information supporting a detention order may consist of classified national security information While we are obliged to provide a fair, expeditious, and impartial hearing, release of classified information is restricted

68. Use of Classified Information (cont.) If FDA may do so (while safeguarding the information/source), FDA will provide the general nature of the information and an opportunity to offer opposing evidence or information If classified information was used to support the detention, then any confirmation of such detention will state whether it is based in whole or in part on that classified information FDA is considering developing general regulations on handling classified information for all FDA-regulated products

69. Next Steps These are proposed rules; there is no duty to comply with the rules now, but note: – The BT Act’s access to records authority is in effect now; however, the Act does not provide a specific time period within which applicable records must be made available to FDA upon an appropriate request (Act says records must be made available at “reasonable times”) – Administrative detention authority is in effect now. Until final regulations are published and in effect, 21 CFR Part 16 would apply to any detention proceedings.

70. Next Steps (cont.) Comments on the records and detention proposed rules are due no later than July 8, 2003 FDA plans to publish the final rules by Dec. 12, 2003

71. How Do I Get a Copy of the Proposed 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

72. How To Comment (Deadline July 8, 2003) Submit written comments 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 http://www.fda.gov/dockets/ecomments YOU MUST INCLUDE THE DOCKET NUMBER: – 02N-0277: Records; 02N-0275: Detention

73. For Further Information... For current information on FDA’s efforts under the Bioterrorism Act or to obtain an electronic copy of these slides: For current information on FDA’s efforts under the Bioterrorism Act or to obtain an electronic copy of these slides: http://www.fda.gov/oc/bioterrorism/bioact.html