Overview of Records and Administrative Detention Proposed Regulations Implementing the Bioterrorism Act Leslye M. Frase

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

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 Requirements68 FR 25188 (May 9, 2003) Statutory Deadline: December 12, 2003

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

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

9. Whom Does The Proposed Rule Exclude? Excluded From All Requirements: • Foreign facilities, iffood 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

10. Whom Does The Proposed Rule Exclude? 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

11. Whom Does The Proposed Rule Exclude? 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 unprocessedfood from its farm or a neighboring farm (with respect to records for that unprocessed food) *No exclusion from records access provisions

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 theU.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.) Farmincludes a facility that . . . • Packs or holdsfood if all food is grown or raised on that farm orconsumed on that farm; and • Manufactures/processesfood, if all of the food used in such activities isconsumed on that farmor 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 fooddirectly 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 productsdirectly 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 individualand contact information (domestic or foreign) • Description of type of foodreceived, including brand name and specific variety

24. Records Non-transporters Have To Establish And Maintain to Identify the IPS (cont) • Datefood 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 thetransporters who brought the food to you

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

26. Source C Source A Source B Common Storage Silo Cookies Manufacturing Plant 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

27. Source B Source A Source C Manufacturing Plant Cookies 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

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 Recordsto Identify the ISR (cont)? • Datefood 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 thetransporters who transferred the food from you

30. Company C Manufacturer Company A Company B Retail Store 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)

31. Records Transporters Have To Establish And Maintain to Identify the IPR and ISR For each food you transport . . . • Firm name, including responsible individualand 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 RecordsWould Transporters Have To Establish And Maintain? • Datesfood 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. Company C Manufacturer Company A Company B Retail Store 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).

34. Manufacturer Retail Store 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.

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: • Within4 hoursif requested between 8:00 am and 6:00 pm, Monday-Friday • Within8 hoursif 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 notindividual 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? • Failureto establish and maintain the required records is a prohibited act • Failureto 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 Requirements68 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