Overview of Registration Interim Final Rule Implementing the Bioterrorism Act
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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 Personnel. L. Robert Lake – Senior Manager

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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


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FDA Lead Personnel Bioterrorism Act

  • L. Robert Lake – Senior Manager

    • (301) 436-2379 or Lloyd.Lake@cfsan.fda.gov

  • Leslye M. Fraser – Lead

    • (301) 436-2378 or Leslye.Fraser@cfsan.fda.gov

  • HELP DESK

    • Phone: 800-216-7331 or 301-575-0156

    • E-mail: furls@fda.gov

    • Fax: 301-210-0247


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Background: FDA’s Regulatory Development Timeline Bioterrorism Act

  • Feb. 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)


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Background: FDA’s Regulatory Development Timeline Bioterrorism Act

  • 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 rule takes effect

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


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Regulatory Development Timeline (cont.) Bioterrorism Act

  • 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


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

  • 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


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Who Must Register? Bioterrorism Act

  • 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


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Who Must Register? Bioterrorism Act(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


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U.S. Agent Bioterrorism Act

  • 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


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U.S. Agent (cont.) Bioterrorism Act

  • 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)


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What Food is Subject to FDA’s Jurisdiction? Bioterrorism Act

  • 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.”


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What Food is Subject to FDA’s Jurisdiction (cont)? Bioterrorism Act

  • 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)


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Examples of FDA-regulated Food Within Scope of the Rule Bioterrorism Act

  • 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


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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


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Registration Definitions (cont.)

  • 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


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“Facility” 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


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    Definitions (cont.) (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


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    Definitions (cont.) (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


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    What Facilities Are Exempt? (cont.)

    • 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


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    Definitions (cont.) (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


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    Definitions (cont.) (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


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    Definitions (cont.) (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


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    Definitions (cont.) (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


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    Definitions (cont.) (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


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    Farm 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 farmor another farm under the same ownership


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    Additional Exemption for Some Foreign Facilities (cont.)

    • 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


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    Foreign Facilities— (cont.)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.


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    “Mixed-Type” Facilities (cont.)

    • 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


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    “Mixed-Type” Facilities (cont) (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


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    Two Types of Information: (cont.)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


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    What Information is Required? (cont.)

    • 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


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    What Information Is Required? (cont.)(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)


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    What Information Is Required? (cont.) (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


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    What Information is Optional? (cont.)

    • 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


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    What Information is Optional? (cont.)

    • 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


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    What Information is Optional? (cont.)

    • 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


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    How to Register (cont.)

    • 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


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    How to Register (cont.)

    • 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)


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    How to Register (cont.) (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


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    Costs and Frequency of Registration (cont.)

    • No registration fee

    • Registration is one-time, not annual


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    What if Changes Occur? (cont.)

    • Updates required within 60 days of a change in any mandatory information previously submitted to FDA

    • FDA encouragestimely updates of optional information previously submitted to assist FDA in keeping its database current in order to respond to emergencies


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    Cancellation of Registration (cont.)

    • 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


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    Cancellation of Registration (cont) (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


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    Where to Register, Update or Cancel a Registration (cont.)

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

    • Request a paper copy by mail or phone:U.S. Food and Drug Administration (HFS-681)5600 Fishers LaneRockville, MD, USA 20857877 332-3882

      • Ask for Form 3537 to register or update

      • Ask for Form 3537a to cancel a registration


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    What Are the Consequences of 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


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    Consequences of Failure to Register Required?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


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    Consequences of Failure to Register Required?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


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    Consequences of Failure to Register Required?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


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    How Do I Get a Copy of the Required?Interim Final Rule?

    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


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    How To Comment Required?(Deadline December 24, 2003)

    • Submit written comments to:

      Dockets Management Branch (HFA-305)

      Food and Drug Administration

      5630 Fishers Lane, rm. 1061

      Rockville, MD USA 20852

    • Submit electronic comments to: http://www.fda.gov/dockets/ecomments

    • YOU MUST INCLUDE THE DOCKET NUMBER:

      2002N-0276


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    For Further Information . . . Required?

    • For current information on FDA’s efforts under the Bioterrorism Act or to obtain an electronic copy of these slides:

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


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    Whom Do I Call? Required?

    • Questions regarding the electronic or paper registration:

      • Phone: 800-216-7331 or 301-575-0156

      • Fax: 301-210-0247

      • E-mail: furls@fda.gov

    • Hours of operation are Monday-Friday, from 7 a.m. until 11 p.m., Eastern Time.