Overview of Registration Interim Final Rule Implementing the Bioterrorism Act (68 FR 58894, Oct. 10,...
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Transcript of Overview of Registration Interim Final Rule Implementing the Bioterrorism Act (68 FR 58894, Oct. 10,...
Overview of Registration Interim Final Rule Implementing the
Bioterrorism Act(68 FR 58894, Oct. 10, 2003)
Leslye M. Fraser, Esq.Associate Director for Regulations
Center for Food Safety and Applied Nutrition
FDA Lead PersonnelFDA Lead Personnel L. Robert Lake – Senior Manager
– (301) 436-2379 or [email protected]
Leslye M. Fraser – Lead– (301) 436-2378 or [email protected]
HELP DESK: 800-216-7331 or 301-575-0156 (phone) or [email protected] or 301-210-0247 (fax) – operational Oct. 16, 2003
Background: FDA’s Regulatory Background: FDA’s Regulatory Development TimelineDevelopment Timeline Feb. 3, 2003: FDA and CBP published
proposed rule with a 60 day comment period– FDA received over 350 comments
Oct. 10, 2003: FDA and CBP published interim final rule – Rule takes effect on December 12, 2003– Registration system operational on Oct. 16, 2003 at
6:00 p.m. EST– Comments due on interim final rule by Dec. 23,
2003 (comment period will reopen in March)
Background: FDA’s Regulatory Background: FDA’s Regulatory Development TimelineDevelopment 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 Outreach materials will be available on FDA’s website in website in French, Spanish, Chinese, Japanese, French, Spanish, Chinese, Japanese, Hindi, Portuguese, Arabic, and Malay:Hindi, Portuguese, Arabic, and Malay: http://www.fda.gov/oc/bioterrorism/bioact.html
Regulatory Development Timeline Regulatory Development Timeline (cont.)(cont.) FDA also is developing two additional rules:– Section 306: Establishment and Maintenance
of Records– Section 303: Administrative Detention
Goal: by December 12, 2003, publish final rules implementing these two provisions and hold satellite downlink meeting shortly after
Who Must Register?Who Must Register?
• Owners, operators, or agents in chargeOwners, operators, or agents in charge of of domestic or foreign domestic or foreign facilitiesfacilities that that manufacture/process, pack,manufacture/process, pack, or holdor hold food food (subject to FDA’s jurisdiction) for human (subject to FDA’s jurisdiction) for human or animal consumption in the U.S. or animal consumption in the U.S.
• Domestic facilities are required to register Domestic facilities are required to register whether or not food from the facility enters whether or not food from the facility enters interstate commerceinterstate commerce
Who Must Register?Who Must Register?(cont.)(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
U.S. AgentU.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.
– The U.S. agent acts as a communications link between FDA and the facility for both routine and emergency communications
U.S. Agent (cont.)U.S. Agent (cont.)
– FDA will contact a foreign facility’s U.S. agent if an emergency occurs, 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)
What Food is Subject to FDA’s What Food is Subject to FDA’s Jurisdiction?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.”
What Food is Subject to FDA’s What Food is Subject to FDA’s Jurisdiction (cont)?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)
Examples of FDA-regulated Food Examples of FDA-regulated Food Within Scope of the RuleWithin Scope of the Rule
– Dietary supplements and dietary ingredients– Infant formula– Beverages (including alcoholic beverages
and bottled water)– Fruits and vegetablesFruits and vegetables– Fish and seafoodFish and seafood– Dairy products and shell eggsDairy products and shell eggs
Examples of FDA-regulated Food Examples of FDA-regulated Food Within Scope of the Rule (cont.)Within Scope of the Rule (cont.)
– Raw agricultural commodities for use as Raw agricultural commodities for use as food or components of foodfood or components of food
– Canned and frozen foodsCanned and frozen foods– Live food animalsLive food animals– Bakery goods, snack food, candy, and Bakery goods, snack food, candy, and
chewing gumchewing gum– Animal feeds and pet foodAnimal feeds and pet food
Registration DefinitionsRegistration DefinitionsFacility – 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
““Facility” DefinitionFacility” Definition(cont.)(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 water drinking water collections
and distribution establishments
Definitions (cont.)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
Definitions (cont.)Definitions (cont.)
Packaging – placing food into a container that directly contacts the food that the consumer receives
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
What Facilities Are Exempt?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)
Definitions (cont.)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
Definitions (cont.)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
Definitions (cont.)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
Definitions (cont.)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
Definitions (cont.)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
Farm DefinitionFarm Definition(cont.)(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
Additional Exemption for Some Additional Exemption for Some Foreign FacilitiesForeign 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
Foreign Facilities—Foreign Facilities—Register or Exempt?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.
““Mixed-Type” FacilitiesMixed-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
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
Two Types of Information: Two Types of Information: Mandatory and OptionalMandatory 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
What Information is Required? What Information is Required?
• Name of facility, full address, phone Name of facility, full address, phone numbernumber
• Same information for the parent Same information for the parent company, if the facility is a subsidiarycompany, if the facility is a subsidiary
• The name, address, and phone number The name, address, and phone number of the owner, operator, or agent in of the owner, operator, or agent in chargecharge
• All trade names the facility usesAll trade names the facility uses
What Information Is Required?What Information Is Required?(cont)(cont)
• Name of U.S. agent and contact Name of U.S. agent and contact information (foreign facilities only)information (foreign facilities only)
• Emergency contact phone number Emergency contact phone number (domestic facilities only)(domestic facilities only)• Foreign facilities can opt to include this Foreign facilities can opt to include this
information if they want someone other than their information if they want someone other than their U.S. agent to serve as emergency contactU.S. agent to serve as emergency contact
• Food product categories (21 CFR 170.3)Food product categories (21 CFR 170.3)
What Information Is Required?What Information Is Required? (cont) (cont)
• A statement that the information submitted is A statement that the information submitted is true and accurate and that the individual true and accurate and that the individual submitting the form, if not the owner, operator, submitting the form, if not the owner, operator, or agent in charge, is authorized to do so. or agent in charge, is authorized to do so.
• The submitter, if not the owner, operator, or agent The submitter, if not the owner, operator, or agent in charge, also must provide the name and contact in charge, also must provide the name and contact information of the individual who authorized information of the individual who authorized submission of the formsubmission of the form
What Information is Optional?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
What Information is Optional?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
What Information is Optional?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
How to RegisterHow to Register
FDA strongly encourages electronic registration– Will be available 24 hours/day, 7 days/week
worldwide beginning Oct. 16, 2003, at 6:00 p.m. EST
– Will not allow registration to be submitted until all mandatory fields completed
How to RegisterHow 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: Authorized individual can register foreign facility (e.g., U.S. agent)
How to Register (cont.)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/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
Costs and Frequency of Costs and Frequency of RegistrationRegistration
No registration fee
Registration is one-time, not annual
What if Changes Occur?What if Changes Occur?Updates required within 60 days of
change of 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
What Are the Consequences of What Are the Consequences of Failing to Register, if Required?Failing to Register, if Required?
Failure to register, update, or cancel a registration as required is a prohibited act
FDA can bring civil or criminal action
Consequences of Failure to Register Consequences of Failure to Register If Required (cont)If Required (cont)
If the failure relates to a foreign manufacturer: the food is subject to refusal for failure to provide adequate prior notice (identity of facility is incomplete)
Consequences of Failure to Register Consequences of Failure to Register If Required (cont)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
Consequences of Failure to Register Consequences of Failure to Register If Required (cont.)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
How Do I Get a Copy of theHow Do I Get a Copy of theFinal Rule(s)?Final Rule(s)?
http://www.fda.gov/oc/bioterrorism/bioact.htmlhttp://www.fda.gov/oc/bioterrorism/bioact.html
• Or write to:Or write to:
Dockets Management Branch Dockets Management Branch (HFA-305)
Food and Drug AdministrationFood and Drug Administration
5630 Fishers Lane, Room 10615630 Fishers Lane, Room 1061
Rockville, MD USA 20852Rockville, MD USA 20852
For Further Information . . .For Further Information . . .
For current information on FDA’s efforts For current information on FDA’s efforts under the Bioterrorism Act or to obtain under the Bioterrorism Act or to obtain an electronic copy of these slides: an electronic copy of these slides:
http://www.fda.gov/oc/bioterrorism/bioact.html
Whom Do I Call?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: [email protected]
Beginning October 16, 2003, hours of operation are Monday-Friday, from 7 a.m. until 11 p.m., Eastern Standard Time.