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

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

2. Purpose of Briefing • Provide status of development of: • Recordkeeping Final Rule • Administrative Detention Final Rule • Provide overviews of: • Registration Interim Final Rule • Prior Notice Interim Final Rule • FDA’s and CBP’s enforcement discretion policy and joint implementation plan

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

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

5. Development of Registration and Prior Notice Rules • Feb. 3, 2003: FDA and Customs and Border Protection (CBP) published proposed rules with a 60 day comment period • FDA received over 350 comments on Registration and 470 comments on Prior Notice • Oct. 10, 2003: FDA and CBP published interim final rules (68 FR 58894, 68 FR 58974) • Registration System operational Oct. 16, 2003 • Prior Notice Systems operational Dec. 12, 2003

6. Background: 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 • Dec. 12, 2003: Interim final rules took effect • Dec. 24, 2003: First comment period on IFR closed; will reopen in April 2004 for 30 days

7. Background: What Is An Interim Final Rule (IFR)? • An IFR is a final rule that has • the full force and effect of law • affected parties have an obligation to comply with its requirements • An IFR allows stakeholders to • submit comments during the public comment period on the areas requested in the interim final rule • The agency will consider timely comments before deciding whether to issue a revised final rule or confirm the interim final rule as final

8. How Do I Get a Copy of theInterim Final Rules? http://www.fda.gov/oc/bioterrorism/bioact.html • Or write to: Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD USA 20852

9. How To Comment (1 of 2) NOTE: FDA will consider only those comments submitted during an open comment period • Submit written comments to: Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD USA 20852

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

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

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

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

14. 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. Bioterrorism Act of 2002Section 305

15. Overview of Registration Requirements • Points to Cover: • Who Must Register • Scope of Rule/Food • Definitions • Exemptions • What Information is Required • How to Register • Consequences of Failing to Register

16. Who Must Register? • Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack,or hold food (subject to 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. Who Must Register?(cont.) • Owners, operators, or agents in charge may choose to authorize an individual to register on behalf of the facility • The requirement applies to each covered facility, not to firms or companies as a whole • E.g., company with 10 facilities must register each one separately

18. U.S. Agent • Foreign facilities are required to have a U.S. agent • U.S. Agent can be any “person” thatresides or maintains a place of business in the U.S. and is physically present in the U.S. • “Person" is defined as an individual, partnership, corporation, or association

19. U.S. Agent (cont.) • Acts as a communications link between FDA and the facility • for both routine and emergency communications, • unless the facility opts to designate a different emergency contact • Having one U.S. agent for registration purposes does not preclude a foreign facility from having multiple agents for other purposes (E.g., sales)

20. What Food is Subject to 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. 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. Examples of FDA-regulated Food Within Scope of the Rule • Dietary supplements and dietary ingredients • Infant formula • Beverages (including alcoholic beverages and bottled water) • Fruits and vegetables • Fish and seafood • Dairy products and shell eggs

23. Examples of FDA-regulated Food Within Scope of the Rule (cont.) • Raw agricultural commodities for use as food or components of food • Canned and frozen foods • Live food animals • Bakery goods, snack food, candy, and chewing gum • Animal feeds and pet food

24. Registration Definitions • Facility – • an establishment or structure(s) • under one ownership • at one general physical location • (or in the case of a mobile facility, traveling to multiple locations), • that manufactures/processes, packs, or holdsfood for human or animal consumption in the U.S. • A “facility” may be one food processing plant with multiple buildings in one location

25. “Facility” Definition(cont.) • A building that has multiple companies at the same address would be considered 2 or more facilities • What is not a facility: • Transport vehicles if they hold food only in the usual course of business as carriers • A private residence of an individual • Non-bottled drinking water collection and distribution establishments

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

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

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

29. What Facilities Are Exempt? • Facilities regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture (USDA) • Note: USDA regulates meat products, poultry products, and egg products • Facilities that only hold food in the usual course of business as a carrier (e.g., post offices, truck terminals, express courier facilities)

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

31. Definitions (cont.) • Retail establishment: • An establishment that sells food products directly to consumers as its primary function • An establishment that manufactures/ processes, packs, or holds food if the establishment’s primary function is to sell food, including food that it manufactures/ processes, or holds, directly to consumers

32. Definitions (cont.) • Note: • Businesses are not considered consumers • Primary function is measured by annual sales to consumers, which must be greater than annual sales to non-consumers

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

34. Definitions (cont.) • Farm: a facility in one general physical location devoted to the growing and harvesting of crops for food and/or the raising of animals for food (including seafood) • Washing, trimming outer leaves, and cooling produce are considered part of harvesting when done on a farm • E.g., apple orchards, dairy farms, feedlots, and aquaculture facilities

35. Farm Definition(cont.) Farm includes a facility that . . . • Packs or holds food if all food is grown or raised on that farm or consumed on that farm or another farm under the same ownership; or • Manufactures/processes food, if all of the food used in such activities is consumed on that farmor another farm under the same ownership

36. Allowable Farm Activities(If facility otherwise meets the farm definition) • Applying pesticides on a farm to pre-harvested crops • Use of chlorinated water to wash crops – depends on source and level of chlorine • Placing stickers on fruit • Placing a raw agricultural commodity directly into consumer-ready packages

37. Additional Exemption for Some Foreign Facilities • Foreign facilities that manufacture/ process, pack, or hold food are exempt if a subsequent foreign facility further manufactures/processes (including packages) the food, except • if the subsequent facility performs labeling or any similar activity of a de minimis nature, both foreign facilities must register

38. Foreign 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. “Mixed-Type” Facilities • If an establishment is a combination of a facility subject to the rule and an exempt facility, the facility is required to register • E.g., a farm that grows oranges and manufactures/ processes the oranges into juice for sale to a distributor must register because the manufacturing/processing activity is subject to the rule

40. “Mixed-Type” Facilities (cont) • A facility is exempt from registering only if all of its activities are included in one or more exemptions • E.g., a farm that sells the orange juice it produces to consumers as its primary function would be exempt under the farm exemption and the retail exemption

41. Two Types of Information: Mandatory and Optional • All mandatory fields in a registration must be completed, except: • Facilities that select “most/all” for food product categories do not have to identify individual categories on the registration • FDA encourages submission of optional information to assist with communications with the facility

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

43. What Information Is Required?(cont) • Name of U.S. agent and contact information (foreign facilities only) • Emergency contact phone number (domestic facilities only) • Foreign facilities can opt to include this information if they want someone other than their U.S. agent to serve as the emergency contact • Food product categories (21 CFR 170.3)

44. What Information Is Required? (cont) • A statement that the information submitted is true and accurate and that the individual submitting the form (if not the owner, operator, or agent in charge) is authorized to do so. • The submitter, if not the owner, operator, or agent in charge, also must provide the name and contact information of the individual who authorized submission of the form

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

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

47. What Information is Optional? • Fax number and e-mail address of the owner, operator, or agent in charge • Fax number and email address of the owner, operator, or agent in charge • For domestic facilities • Fax & email address of the parent company • Emergency contact name, title, and e-mail address • For foreign facilities • Emergency contact name, title, phone number, and e-mail address

48. How to Register • FDA strongly encourages electronic registration • Available 24 hours/day, 7 days/week worldwide where ever Internet is accessible • Will not allow registration to be submitted until all mandatory fields are completed

49. How to Register • Will provide automatic receipt of registration and 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. 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