Overview of Registration Interim Final Rule Implementing the Bioterrorism Act (68 FR 58894, Oct. 10, 2003)

Overview of Registration Interim Final Rule Implementing the

Bioterrorism Act(68 FR 58894, Oct. 10, 2003)

Background: FDA’s Regulatory Background: FDA’s Regulatory Development TimelineDevelopment TimelineFeb. 3, 2003: FDA and Customs and

Border Protection (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 (registration system operational on Oct. 16, 2003)

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 ArabicArabic , Chinese, , Chinese, French, Hindi, French, Hindi, Japanese, Malay, Portuguese, and Spanish:Japanese, Malay, Portuguese, and Spanish:

http://www.fda.gov/oc/bioterrorism/bioact.html

Dec. 12, 2003:Dec. 12, 2003: Interim final rule takes effect Interim final rule takes effect

Dec. 24, 2003: Comments due on interim final rule (comment period will reopen in March 2004)

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

What Is An Interim Final Rule (IFR)?What Is An Interim Final Rule (IFR)?

An IFR is a final rule that has the full force and effect of law; thus, 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 that the agency will consider before deciding whether to issue a revised final rule or confirm the interim final rule as final

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

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.

“Person" is defined as an individual, partnership, corporation, or association

U.S. Agent (cont.)U.S. Agent (cont.)

– The U.S. agent 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)

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 drinking water collection 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.)

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.) 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., hot peppers, pumpkins 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 must register because the manufacturing/processing activity is subject to the rule

““Mixed-Type” Facilities (cont)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

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 the emergency contactU.S. agent to serve as the 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– 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

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: An authorized individual can register a 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 registrations per 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 a

change in 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

Cancellation of Registration Cancellation of Registration

A facility canceling its registration must do so within 60 days of the reason for cancellation

– E.g., facility ceases operations, ceases providing food for consumption in the U.S., or facility is sold to a new owner

Cancellation of Registration (cont)Cancellation of Registration (cont)

Cancellation may be done electronically or by mail and must include:– Facility’s registration number– Whether facility is domestic or foreign– Facility name and address– Name and address of the individual

submitting the cancellation– Statement certifying information is true and

accurate and person is authorized to submit cancellation

Where to Register, Update or Cancel a Where to Register, Update or Cancel a RegistrationRegistration

Electronically: Electronically: http://www.fda.gov/furls

Request a paper copy by mail or phone:Request a paper copy by mail or phone:U.S. Food and Drug Administration (HFS-681)U.S. Food and Drug Administration (HFS-681)5600 Fishers Lane5600 Fishers LaneRockville, MD, USA 20857Rockville, MD, USA 20857877 332-3882877 332-3882– Ask for Form 3537 to register or updateAsk for Form 3537 to register or update– Ask for Form 3537a to cancel a registrationAsk for Form 3537a to cancel a registration

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 a 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)

– Note: Registration for foreign facilities will be enforced through prior notice

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 theInterim Final Rule?Interim Final Rule?

http://www.fda.gov/oc/bioterrorism/bioact.html

http://www.namdevco.comhttp://www.namdevco.com• 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