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

New FDA Rules Implementing the Bioterrorism Act of 2002

Overview of Registration and Prior Notice Interim Final Rules

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Purpose of BriefingPurpose 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

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FDA Lead PersonnelFDA Lead Personnel L. Robert Lake – Senior Manager

– (301) 436-2379 or [email protected]

Leslye M. Fraser – Regulations Development Lead– (301) 436-2378 or [email protected]

Louis J. Carson – Outreach Lead– (301) 436-2130 or [email protected]

Deborah Ralston – Prior Notice Implementation– (301) 443-6230 or [email protected]

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Status of Recordkeeping and Status of Recordkeeping and Administrative DetentionAdministrative 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

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Development of Registration and Development of Registration and Prior Notice RulesPrior 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

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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 rules took effect Interim final rules took effect

Dec. 24, 2003: First comment period on IFR closed; will reopen in April 2004 for 30 days

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

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How Do I Get a Copy of theHow Do I Get a Copy of theInterim Final Rules?Interim Final Rules?


• 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

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How To Comment How To Comment (1 of 2)(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 Administration5630 Fishers Lane, rm. 1061Rockville, MD USA 20852

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How To CommentHow To Comment(2 of 2)(2 of 2)

Submit electronic comments to: http://www.fda.gov/dockets/ecomments (no attachments); [email protected] (with attachments)

YOU MUST INCLUDE THE DOCKET NUMBER:

2002N-0276 Registration

2002N-0278 Prior Notice

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Compliance Policy – Exercise of Compliance Policy – Exercise of Enforcement DiscretionEnforcement 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

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Compliance Policy (cont.)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.

An Overview of the

Registration of Food Facilities Interim Final Rule

68 FR 58894 (Oct. 10, 2003)

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Bioterrorism Act of 2002Bioterrorism Act of 2002Section 305Section 305

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.

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Overview of Registration Overview of Registration RequirementsRequirements

Points to Cover: Who Must Register Scope of Rule/Food Definitions Exemptions What Information is Required How to Register Consequences of Failing to Register

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WhoWho Must Register? Must Register?

Owners, operators, or agents in charge of Owners, operators, or agents in charge of domestic or foreign facilities that domestic or foreign facilities that manufacture/process, pack,manufacture/process, pack, or hold food or hold 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

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WhoWho Must Register? 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

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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

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U.S. Agent (cont.)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)

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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.”

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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)

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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

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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

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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

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““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

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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

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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

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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))

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What Facilities Are Exempt?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)

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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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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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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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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.)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

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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

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Allowable Farm ActivitiesAllowable Farm Activities(If facility otherwise meets the farm definition)(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 fruitPlacing a raw agricultural commodity

directly into consumer-ready packages

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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

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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.

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““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

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““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

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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

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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 of The name, address, and phone number of the owner, operator, or agent in chargethe owner, operator, or agent in charge

All trade names the facility usesAll trade names the facility uses

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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 information if they want someone other than their U.S. agent to serve as the emergency their U.S. agent to serve as the emergency contactcontact

Food product categories (21 CFR 170.3)Food product categories (21 CFR 170.3)

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What Information Is Required?What Information Is Required? (cont) (cont)

statement that the information submitted is 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

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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

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• 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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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 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

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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)

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How to Register (cont.)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

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Costs and Frequency of Costs and Frequency of RegistrationRegistration

No registration fee

Registration is one-time, not annual

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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

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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

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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

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

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

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

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Confidentiality of Registration Confidentiality of Registration InformationInformation

The Bioterrorism Act precludes FDA from publicly disclosing registration numbers and related registration information.

Facilities are not precluded from sharing their registration numbers with third parties, but are urged to treat them as sensitive business information.

– In some instances, a facility will need to provide its registration number to persons who may be submitting prior notice for a product manufactured by the facility.

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Registered FacilitiesRegistered Facilities

FDA estimated 420,000 facilities worldwide need to register

As of March 30, 2004:– Domestic (U.S.) registrations: 95,091– Foreign registrations: 100,838– Total: 195,929

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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

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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 (will be discussed later in more detail)

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Questions on the Registration Interim Questions on the Registration Interim Final Rule ???Final Rule ???

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Intermission!Intermission!

This session will resume shortly, please join us again then!

An Overview of the

Prior Notice of Imported Food

Interim Final Rule68 FR 58974 (Oct. 10, 2003)

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Bioterrorism Act of 2002Bioterrorism Act of 2002Section 307Section 307

For an article food imported or offered for import into the U.S, the Secretary shall require the submission of prior notice providing the identity of the following:– The article– Manufacturer and shipper of the article– The grower, if known – Country of origin– Country from which the article is shipped– Anticipated port of entry

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Overview of Prior Notice Overview of Prior Notice RequirementsRequirements

Points to CoverThe Current Import ProcessThe New Process (Prior Notice)DefinitionsExemptionsHow to Submit Prior NoticeWhat Information is RequiredConsequences of Inadequate Prior Notice

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The Current Import ProcessThe Current Import Process

Information:Filer ImporterConsignee ManufacturerProduct HTS codeQuantity Country of OriginValue Carrier informationEntry type Entry NumberArrival date Port of Entry

. . . and more

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The Current Import ProcessThe Current Import ProcessInformation provided to CBP about entry

– electronically through ABI (>98%)– by customs broker (filer)

Same information forwarded to FDA– electronically to OASIS– by CBP

Additional Information for FDAFDA Product Code, Affirmations of Compliance, FDA Country of Origin, Manufacturer, and Shipper

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The Current Import ProcessThe Current Import ProcessEvaluated by FDA

– electronic screening– human assessment

Admissibility decision by FDA– electronically from FDA to CBP to broker– Notices (paper) to importer

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The Current Import ProcessThe Current Import Process

WHEN– Maximum prior time set by CBP according

to mode of transportation – CBP (and FDA) screening response

no more than 5 days before arrival if by sea

no sooner than wheels-up if by airat arrival if by land

PRIOR NOTICE OF PRIOR NOTICE OF IMPORTED FOODIMPORTED FOOD

THE NEW IMPORT PROCESS

beginning Dec. 12, 2003

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The New Import Process The New Import Process (Prior Notice)(Prior Notice)

New Information– Country from which the article is shipped– Crossing location within the port of arrival

Revised Information– Actual manufacturer– Registration number

Manufacturer Shipper

– Grower, if known

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The New Import Process The New Import Process (Prior Notice)(Prior Notice)

New ProceduresInformation screened by FDA

– Regardless of source (CBP or PNSI)– Electronically

Additional FDA staff assessment– 24/7– Centrally located

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Prior Notice vs. 801(a) AdmissibilityPrior Notice vs. 801(a) Admissibility

A determination that an article of food is no longer subject to hold for a prior notice or registration violation:– Is different than, and may come before,

determinations of admissibility under other provisions of the FD&C Act or other U.S. laws

– Does not mean that the food will be granted admission under other provisions of the FD&C Act or other U.S. laws.

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Prior Notice vs. 801(a) Admissibility Prior Notice vs. 801(a) Admissibility (cont.)(cont.)

If not examined at border under prior notice:– Food still may be examined or sampled at an inland

location or importer’s premises or public storage– Routine notices follow decision to examine or

sample

NOTE: Most holds on food to date are not for prior notice – they are routine sampling or inspection holds

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FDA’S Prior Notice:FDA’S Prior Notice:DefinitionsDefinitions

International Mail – foreign national mail services– Does not include express carriers,

express consignment operators, or other private delivery services

Port of Arrival – water, air, or land port at which the article of food is imported or offered for import into the U.S. (i.e., the port where the article of food first arrives in the U.S.)– Note: May be different from the port

where food is entered for CBP purposes

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FDA Country of ProductionFDA Country of Production(Originating Country)(Originating Country)

For food in its natural state -- the country where the article of food was grown or collected, including harvested and readied for shipment to the U.S.– For wild fish or seafood caught or harvested

outside the waters of the U.S. by a vessel that is not registered in the U.S.: the country in which the vessel is registered

– For an article of food that was grown in a U.S. Territory: the U.S.

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FDA Country of Production FDA Country of Production vs. CBP Country of Originvs. CBP Country of Origin

The “Bean Example”: beans are grown and dried in the U.S., then rehydrated and canned in Country D– CBP identifies the country of origin as the

U.S.– For purposes of prior notice, FDA identifies

the “article of food” as canned beans, not dried beans

– Thus, “FDA Country of Production” is Country D

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FDA’S Prior Notice: FDA’S Prior Notice: DefinitionsDefinitions

Shipper – the owner or exporter of the article of food who consigns and ships the article from a foreign country or the person who sends an article of food by international mail to the U.S.

United States – the Customs territory of the United States (i.e., the 50 States, the District of Columbia, and the Commonwealth of Puerto Rico, but not the Territories)

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““Article of Food” vs. Article of Food” vs. Shipment of Food*Shipment of Food*

Tuna 24/12 oz cans 2000 cases Company 1



Tuna 6/66oz cans 2400 cases Company 3

*1 Shipment; 4 different products; 4 prior notices

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What Food Imports are Subject to What Food Imports are Subject to Prior Notice?Prior Notice?

Unless excepted, all food for humans and animals that is imported or offered for import into the United States for use, storage, or distribution in the U.S., including:

– Food for gifts and trade

– Quality assurance/quality control samples

– Food for future export

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What Food Imports are Subject to What Food Imports are Subject to Prior Notice (cont)?Prior Notice (cont)?

– Food for transshipment through the U.S. to another country

– Food for use in a U.S. Foreign Trade Zone (FTZ)

– Food sent by mail

– Food sent by express couriers

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What Definition of “Food” Applies?What Definition of “Food” Applies?

With some exceptions, the definition in section 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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– 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

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– Raw agricultural commodities for use as food Raw agricultural commodities for use as food or components of foodor components of food

– Canned and frozen foodsCanned and frozen foods– Live food animalsLive food animals– Bakery goods, snack food, candy, and chewing Bakery goods, snack food, candy, and chewing

gumgum– Animal feeds and pet foodAnimal feeds and pet food

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What is Excluded from the Prior What is Excluded from the Prior Notice Food DefinitionNotice Food Definition

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)

Meat, poultry and egg products that at the time of importation are subject to USDA’s exclusive jurisdiction

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What Kinds of Food Imports are What Kinds of Food Imports are NotNot Subject to Prior Notice?Subject to Prior Notice?

Food carried by or otherwise accompanying an individual for personal use (i.e., consumption by self, family, or friends, not for sale or other distribution)

Food made by an individual at home sent as a personal gift (i.e., not for business reasons) to an individual in the U.S.

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What Kinds of Food Imports are What Kinds of Food Imports are NotNot Subject to Prior Notice?Subject to Prior Notice?

Food that is imported then exported without leaving the port of arrival until export

Food brought into the U.S. in a diplomatic pouch

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Comparison of “Food” for Comparison of “Food” for Registration and Prior NoticeRegistration and Prior Notice

Registration requirements – only apply if food will be consumed in the U.S. by humans or animals

Prior Notice requirements – applies to all food that is imported or offered for imported into the U.S. regardless of whether it will be consumed in the U.S.

Both rules – quantity is not a factor (e.g., both rules apply to samples if above criteria are met)

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Who is Authorized to Provide Who is Authorized to Provide Prior Notice?Prior Notice?

“Submitter” can be any person with knowledge of the required information

“Transmitter” is a person who transmits the required information to FDA for the submitter

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How Do I Submit Prior Notice?How Do I Submit Prior Notice? All prior notice information must be in the

English language using the Latin (Roman) alphabet, except:– individual's name, the name of a company, and the

name of a street may be submitted in a foreign language

Must be submitted electronically through CBP’s Automated Broker Interface of the Automated Commercial System (ABI/ACS), or FDA’s PN System Interface (PNSI) at http://www.access.fda.gov

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Submitting Prior Notice (cont.)Submitting Prior Notice (cont.)

NOTE: PNSI submission is required for:– Articles of food imported or offered

for import by international mail– Transaction types that cannot be

made through ABI/ACS– Articles of food that have been

refused for inadequate prior notice

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If this isn’t working . . .

Then file here In this form:

Customs broker’s or self-filer’s system, or ABI/ACS

FDA PNSI Electronically

PNSI (FDA will post notice at http://www.access.fda.gov)

FDA (see http://www.fda.gov – see Prior Notice for locations)

Via e-mail or fax

(unless using ABI/ACS)

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If this isn’t working . . .

Then file here In this form:

OASIS (FDA will post notice at http://www.access.fda.gov and messages in ABI/ACS)

FDA (see http://www.fda.gov – see Prior Notice for locations)

Via e-mail or fax

Note: PN will only be accepted by e-mail or faxif FDA determines PNSI or OASIS is not working

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When Is My Prior Notice Due?When Is My Prior Notice Due? Except for food arriving by

international mail, prior notice cannot be submitted more than 5 days before arrival

Arrival by land via road: PN must be given no less than 2 hours before the food arrives at the port of arrival

Arrival by air and land via rail: PN must be given no less than 4 hours before the food arrives at the port of arrival

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When Is My Prior Notice Due? When Is My Prior Notice Due? (cont.)(cont.)

Arrival by water: PN must be given no less than 8 hours before the food arrives at the port of arrival

Food carried by or accompanying an individual – time is based on manner of transportation

Food arriving by international mail – the prior notice must be submitted before the food is mailed

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What Information is Required in a What Information is Required in a Prior Notice?Prior Notice?

* indicates that if registration number is provided, then only city and country are required instead of full address

Submitter* (name, address, phone, fax, e-mail) Transmitter* (name, address, phone, fax, e-

mail) CBP Entry type (e.g., Consumption entry,

Warehouse entry, Transportation and Exportation entry)

CBP Entry Identifier (e.g., entry number or in-bond number)

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Identity of the article of food– Complete FDA product code– Common or usual name or market name– Estimated Quantity– Lot or code numbers, if required by FD&C

Act or FDA regulations E.g., low acid canned foods, infant formula,

acidified foods

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† indicates not required for an article of food imported or offered for import for transshipment, storage, and export, or further manipulation and export

For food no longer in its natural state -- manufacturer and registration number* †– Not required for food sent by individual as personal

gift (provide name and address of firm on label)

For food in its natural state -- grower, if known

FDA Country of Production

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Shipper and registration number*†

Country from which the article is shipped

Anticipated arrival information– Port of arrival (and border crossing)– Date of arrival– Time of arrival

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What Information is Required in a What Information is Required in a Prior Notice? (cont.)Prior Notice? (cont.)

Name and address of importer*†

Name and address of owner (if different than importer or ultimate consignee) *†

Name and address of ultimate consignee*†

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Mode of transportation

Carrier - Standard Carrier Abbreviation Code (SCAC) or International Air Transportation Association (IATA) code carrying the food from the country from which it is shipped

HTS (Harmonized Tariff Schedule) code

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Planned shipment information:– All: airway bill number or bill of lading number, and

container number if containerized cargo– Vessel: vessel name and voyage number– Air: flight number– Road: trip number– Rail: car number– Private vehicle: license plate number and

State/province

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Requirements for Food Arriving by Requirements for Food Arriving by International MailInternational Mail

All information previously listed, except:– Anticipated port, date, and time of arrival– Importer, owner, or ultimate consignee– Mode of transport– Carrier and planned shipment information– HTS Code

Additional information required:– Date of shipment– U.S. recipient

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Requirements for Food Refused for Requirements for Food Refused for Inadequate Prior NoticeInadequate Prior Notice

All information previously listed, except:– Anticipated port, date, and time of

arrival

Additional information required:– U.S. recipient– Hold location

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What Happens When FDA What Happens When FDA Accepts Your PN For Review?Accepts Your PN For Review?

FDA will notify you that your PN has been confirmed for review with a reply message containing a PN Confirmation Number– Prior Notice “clock” (for timeliness of

notice) starts when FDA confirms PN

– Note: receipt of confirmation does not mean that FDA has determined the PN is timely or accurate

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Prior Notice Confirmation Number Prior Notice Confirmation Number Must Accompany . . .Must Accompany . . .

… any article of food arriving by international mail; number must be on Customs Declaration;

… food brought in by individual for non-personal use; and

… any article of food for which PN was submitted through PNSI when the article arrives in the U.S.; number must be provided to CBP or FDA upon arrival

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What if the Information Changes What if the Information Changes After I Submit a Prior Notice?After I Submit a Prior Notice?

If change is to estimated quantity, anticipated arrival information, planned shipment information or estimated date of mailing – no action required

All other changes – must submit new prior notice, unless food will not be offered for import into the U.S.– Should also cancel PN previously submitted (PNSI

or ABI/ACS depending on how PN was filed)– Timeframe will restart

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What Happens to Food Without What Happens to Food Without Adequate Prior Notice?Adequate Prior Notice?

No or inaccurate prior notice – food is subject to refusal

Untimely prior notice - food is subject to refusal, unless FDA has already reviewed the notice and notified CBP of its response

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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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Refused food is general order merchandise (19 U.S.C. 1490) and must be moved under appropriate custodial bond

Refused food must not be entered with CBP; it must not be delivered to importer, owner, or ultimate consignee until prior notice requirements met

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Consequences of Failure to Submit Consequences of Failure to Submit Adequate Prior NoticeAdequate Prior Notice

Prohibited act to import or offer for import food without providing prior notice– FDA can bring a civil or criminal action in

federal court

– FDA can seek to debar persons under section 304 of the Bioterrorism Act

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Consequences of Failure to Register Consequences of Failure to Register If RequiredIf Required

If the failure relates to the manufacturer: the food is subject to refusal for failure to provide adequate prior notice – (Identity of facility is incomplete)

Same consequences for inadequate prior notice apply

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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

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FDA-CBP JointFDA-CBP JointImplementation PlanImplementation Plan

Published in April 2004: plan includes a schedule for coordinating timeframes for implementing FDA’s prior notice information and CBP’s advanced electronic information (69 FR 68140, Dec. 5, 2003)

CBP advance notice timeframes:– 1 hour before arrival by land by road, or 30 minutes

for participants in FAST/C-TPAT;– 2 hours before arrival by land by rail; and– By “wheels up” for flights originating in North and

Central America, South America (north of the Equator only), the Caribbean, and Bermuda; otherwise 4 hours before arrival by air

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Compliance StatusCompliance Status

FDA and CBP have posted on their websites summaries of compliance statistics– “Complete” prior notice does not mean prior

notice data elements are accurate– Enforcement discretion period – not

monitoring

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ACS Submission By SourceACS Submission By Source

0

10000

20000

30000

40000

50000

60000

70000

80000

Dec. 27 Jan. 3 Jan. 10 Jan. 17 24-Jan 31-Jan 7-Feb 14-Feb 21-Feb

Blue: Products with “complete” dataYellow: Products with incomplete dataGreen: Products with no prior notice data

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Percent of Information CompletePercent of Information Complete

0.00

20.00

40.00

60.00

80.00

100.00

120.00

Subm

itter

Arriva

l

Carrie

r

Owne

r

Impo

rter

Consig

nee

Produ

ct D

esc

Qua

ntity

Produ

ct C

ode

Bill of

Lad

ing

Man

ufac

ture

r Reg

istra

tion

Count

ry o

f Shi

ppin

g

ACS

PNSI

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Percent Complete by Mode of Percent Complete by Mode of Transportation (ACS)Transportation (ACS)

0.00

20.00

40.00

60.00

80.00

100.00

120.00

Subm

itter

Arriva

l

Carrie

r

Owne

r

Impo

rter

Consig

nee

Produ

ct Des

c

Qua

ntity

Produ

ct Cod

e

Bill of

Lad

ing

Mnf

g. R

egist

ratio

n

Count

ry o

f Shi

ppin

g

Sea

Rail

Road

Air

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Percent Complete by Mode of Percent Complete by Mode of Transportation (PNSI)Transportation (PNSI)

0

20

40

60

80

100

120

Subm

itter

Arriva

l

Carrie

r

Owne

r

Impo

rter

Consig

nee

Produ

ct Des

c

Qua

ntity

Produ

ct Cod

e

Bill of

Lad

ing

Man

uf R

eg

Count

ry o

f Shi

ppin

g

Sea

Rail

Road

Air

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For Further Information . . .For Further Information . . .

For current information on FDA’s efforts under For current information on FDA’s efforts under the Bioterrorism Actthe Bioterrorism Act


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Questions Regarding “Does The Rule Questions Regarding “Does The Rule Apply to My Activity?”Apply to My Activity?”

To date, FDA has received over 100,000 inquiries, more than 2/3 of which are questions of applicability

Please read the rules first – many questions are answered there

Next, please see our website for Question and Answer (Q&A) documents in which we respond to new questions: http://www.cfsan.fda.gov/~dms/guidance.html

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Questions Regarding Does A Rule Questions Regarding Does A Rule Apply to What I Do?Apply to What I Do?

If your question is not answered in any of the above, please send it to us:

– Phone: 800-216-7331 or 301-575-0156– Fax: 301-210-0247 – E-mail: [email protected]

Please note, given the volume of questions we receive:

– You generally will not receive an individual response

– We will answer new questions in a future Q&A Document

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Technical Assistance QuestionsTechnical Assistance Questions

Questions regarding how to access the electronic or paper registration:– Phone: 800-216-7331 or 301-575-0156– Fax: 301-210-0247 – E-mail: [email protected] – Hours of operation are Monday-Friday, from 7

a.m. until 11 p.m., Eastern Time.

Questions regarding prior notice system issues: Deborah Ralston – (301) 443-6230 or [email protected]

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

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Transcript of New FDA Rules Implementing the Bioterrorism Act of 2002 Overview of Registration and Prior Notice...