FDA Food Safety Modernization Act and Registration of Food Facilities

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1 FDA Food Safety Modernization Act and Registration of Food Facilities Layla Batarseh, Ph.D. Senior Regional Advisor Middle East and North Africa Post U.S. Food and Drug Administration Amman, Jordan April 23,

2 Disclaimer This presentation constitutes an informal communication that represents the best judgment of the speaker at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of U.S. FDA, and does not bind or otherwise obligate or commit the U.S. FDA to the views expressed htm 2

3 Presentation Objectives To provide information regarding food facility registration requirements as amended by the FDA Food Safety Modernization Act including: 1. Registration background 2. Additional registration information requirements 3. Registration renewal for food facilities 4. Suspension of food facility registration 3

4 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 4

5 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 5

6 Food Facility Registration Food facilities subject to Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that manufacture/process, pack, or hold food for consumption in the United States must register before the facility begins such operations (21 CFR 1.230) If a change occurs to a facility s previously submitted required registration information, such facility must update its registration to reflect the change within 60 calendar days of the change, except for a change of the owner (21 CFR 1.234) 6

7 Food Facility Registration If a facility has a new owner, the former owner must cancel the facility s registration within 60 calendar days of the change and the new owner must submit a new registration (21 CFR 1.234) 7

8 The U.S. Agent Foreign firms are required to identify a person as an agent who is physically located within the United States A person" can be an individual, society, corporation, partnership, or association and does not need to be paid The agent acts as a communication link between FDA and the firm if there is a need for the agency to make contact with the firm, for both routinr and emergency communication (unless the firm designates a different emergency contact in Section 5). 8 8

9 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 Chewing gum 9

10 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 10

11 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 11

12 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 12

13 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 13

14 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 14

15 Mixed-Type Facilities 1. If an establishment is a combination of a facility subject to the rule and an exempt facility, the facility is required to register 2. 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 3. A facility is exempt from registering only if all of its activities are included in one or more exemptions 4. 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 15

16 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. 16

17 FDA Food Safety Modernization Act With the passage of the FDA Food Safety Modernization Act (FSMA) (Pub. Law ), domestic and foreign manufacturers, processors, packers or holders of food for human or animal consumption in the United States must comply with new statutory requirements 17

18 Changes to Food Facility Registration Under FSMA FSMA amended Section 415 of the FD&C Act to require in relevant parts that facilities engaged in manufacturing, processing, packing, or holding food for human or animal consumption in the U.S. submit additional registration information to the FDA 18

19 Additional Registration Information Required The address for the contact person of the facility or, in case of a foreign facility, the address of the U.S. Agent for the facility Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act Food product category information as determined necessary and appropriate by FDA 19

20 Biennial Registration Renewal FSMA also amended Section 415 of the FD&C Act to provide that food facilities required to register with FDA must renew their registrations with FDA every two years, between October 1 and December 31 of each even-numbered year At this time, the same types of food facilities that were required to register with FDA under Section 415 of the FD&C Act before FSMA are required to register with FDA and renew such registrations 20

21 Registration Renewal Process 1. Registrants can submit registration renewals at any time during the renewal cycle, using the online food facility registration module or paper Form FDA Online, registrants will have the opportunity to review and edit existing registration information and add additional information 3. Note that all information submitted to FDA must be true and accurate, but only mandatory data fields are required to complete the renewal process 21

22 Registration Renewal Process 4. FDA will accept registration submissions, including initial registrations, updates of registration information, and biennial registration renewals via online entry, mail, fax, or CD-ROM for multiple submissions 5. There is no fee to register, update, renew, or cancel the registration of a food facility 6. Facilities will retain their existing registration number when successfully completing registration renewal process 22

23 Failure to Register The failure to register your facility, update required elements, or cancel a registration in accordance with FDA s registration regulation is considered a prohibited act Additionally, if a foreign food facility fails to register in accordance to FDA s registration regulation, food from that facility that is being imported or offered for import into the U.S. may be subject to refusal Note: Registration for foreign facilities will be enforced through prior notice 23

24 Consequences of Failure to Register If Required (cont.) 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 24

25 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 25

26 Suspension of Registration-1 Section 415(b) of the FD&C Act, as amended by FSMA, also provides FDA with authority to suspend the registration of a food facility in certain circumstances Prior to FSMA, FDA did not have the authority to suspend the registration of a food facility in such circumstances 26

27 Suspension of Registration-2 Under Section 415(b) of the FD&C Act, if FDA determines that food manufactured/processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that: Created, caused or was otherwise responsible for such reasonable probability; OR Knew of or had reason to know of such reasonable probability AND packed, received or held such food. 27

28 Suspension of Registration-3 FDA will provide a registrant subject to an order of suspension of registration with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of a suspension order, unless an alternate time period is agreed upon by FDA and the registrant If the registration of a facility is suspended, no person can import or export food into the United States, offer to import or export food into the United States, or otherwise introduce food into interstate or intrastate commerce in the United States from such facility 28

29 Conclusions Under FSMA: Food facility registrations must be renewed every two years Additional information is now required for initial registration and renewal of food facility registration FDA now has authority to suspend a food facility registration under certain circumstances 29

30 Available Guidance What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide (December 2012) Questions and Answers Regarding Food Facility Registration (Fifth Edition) (December 2012) Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (October 2012) Compliance Policy Guide Sec Food Facility Registration Human and Animal Food (Draft Guidance) (April 2013) 30

31 Whom Do I Call? Questions regarding the electronic or paper registration: Phone: or Fax: furls@fda.gov Hours of operation are Monday-Friday, from 7 a.m. until 11 p.m., Eastern Time. 31

32 For More Information Visit For additional guidance Subscribe to the FSMA Mailing List Call or