# Presentation: 315533

## New FDA Rules Implementing the Bioterrorism Act of 2002

Overview of Registration and Prior Notice Interim Final Rules

**Overview of Registration and Prior Notice Interim Final Rules**

## Purpose 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**

## FDA Lead Personnel

**L. Robert Lake – Senior Manager**
**(301) 436-2379 or **_**[Lloyd.Lake@fda.hhs.gov](mailto:Lloyd.Lake@fda.hhs.gov)**_
**Leslye M. Fraser – Regulations Development Lead**
**(301) 436-2378 or **_**[Leslye.Fraser@fda.hhs.gov](mailto:Leslye.Fraser@fda.hhs.gov)**_
**Louis J. Carson – Outreach Lead**
**(301) 436-2130 or **_**[Louis.Carson@fda.hhs.gov](mailto:Louis.Carson@fda.hhs.gov)**_** **
**Deborah Ralston – Prior Notice Implementation**
**(301) 443-6230 or **_**[Deborah.Ralston@fda.hhs.gov](mailto:Deborah.Ralston@fda.hhs.gov)**_** **

**Notes:**
Talkpoints: FDA personnel who are responsible for implementing the Bioterrorism act are: Robert Lake, who is the senior manager, Leslye Fraser, who is the lead, and Deborah Ralston, who is the prior notice contact. 

## Status of Recordkeeping and Administrative 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**

**Notes:**
Talkpoints: The FDA is also developing 2 additional rules as a part of the Bioterrorism act. These are Section 306, Establishment and Maintenance of Records, and Section 303, Administrative Detention. 
FDA aims to publish final rules implementing 2 provisions by the end of March 2004.
IFR Reference: p. 58895, column 1  

## Development of Registration and Prior 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**

**Notes:**
Talkpoints: For those of you who may not be familiar with our rulemaking process, let me explain a little bit about how it works. Our “notice and comment” form of rulemaking requires that proposed regulations be published in a document called the Federal Register, which is the official U.S. government publication for regulations, guidance documents and related activities. A proposed rule provides notice of what a government agency is considering in a particular regulation, and it allows interested parties to submit comments or suggestions to make the proposed regulation more effective and less burdensome. Comments on a proposed regulation are accepted for a specified period of time. They are carefully considered by the government agency proposing the regulation, and later they are summarized and discussed in the preamble section of the final rule.   
So what does this all mean with respect to the registration rule?  As background, on February 3rd 2003, the FDA in collaboration with CBP published a proposed registration rule with a 60 day comment period. This comment period ended on April 4th, 2003. In case of registration and prior notice, which I will be discussing shortly, many of you sent comments to the proposed rules, and those comments helped shape them into their present form. The FDA received over 350 comments on the proposed registration rule. These comments were carefully reviewed by FDA personnel and taken into consideration when drafting this interim final rule. 
On October 10th, the FDA and CBP published this interim final rule. This rule took effect on December 12th 2003, as required by the Bioterrorism Act. FDA’s, registration system became operational on October 16th 2003. 
IFR reference: p. 58894, columns 2-3 

## Background:  FDA’s Regulatory Development 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 website in ****Arabic**** , Chinese, ****French, Hindi, Japanese, Malay, Portuguese, and Spanish:**
-       	_[http://www.fda.gov/oc/bioterrorism/bioact.html](http://www.fda.gov/oc/bioterrorism/bioact.html)_
**Dec. 12, 2003:****  Interim final rules took effect**
**Dec. 24, 2003:  ****First comment period on IFR closed; will reopen in April 2004 **_***for 30 days***_

**Notes:**
Talkpoints: On October 28, 2003, the FDA held a public meeting via satellite downlink to domestic and international sites. Transcripts are in English, French, and Spanish. 
In addition, outreach materials are available on the FDA’s website in 8 languages. These materials include fact sheets, press releases, tutorials, and overview materials.  
On December 12, 2003 the interim final rule took effect. 
There is a 75 day comment period on the interim final rule which began on October 10th and ended on December 24th. In addition, to ensure that those commenting on this interim final rule have had the benefit of FDA’s outreach and educational efforts and have had experience with the systems, timeframes, and date elements of this interim final rule, the agency intends to reopen the comment period for an additional 30 days beginning in March 2004. 
FDA has issued two compliance policy guides, which state that during the first 8 months of implementation (until Aug. 12, 2003), FDA will focus primarily on educating stakeholders rather than enforcing all violations of either the Registration or Prior Notice IFR’s.
IFR Reference: p. 58897 column 2 

## Background: What Is An Interim 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**

**Notes:**
Talkpoints: As we all work together to protect the public safety, FDA also intends to be as flexible as possible to accommodate this transition. We will exercise our enforcement discretion during the first eight months following the effective date of December 12, 2003.  We will focus on helping those affected by these new rules in understanding the new requirements and how to comply with them. FDA will be working hard with industry and with our trading partners over the next several months to expand our education and outreach activities to maximize understanding of the new rules. Given the potential impact of these regulations, we are taking the relatively unusual step of issuing these as "interim final rules."  While they will take effect on December 12, 2003, as required by the Bioterrorism Act, FDA will accept comments on certain areas specified in the rules for 75 days or until December 24, 2003.  
FDA will consider only those comments reviewed during an open comment period and determine whether we need to make further modifications to the rules – however, I do want to emphasize that these rules took effect as required on December 12, 2003.
The interim final rule does have the full force of law, even though the comment period is still open with respect to some issues. 
The 75 day comment period began on October 10th and ends December 24rd. In addition, to ensure that those commenting on this interim final rule have had the benefit of FDA’s outreach and educational efforts and have had experience with the systems, timeframes, and date elements of this interim final rule, the agency intends to reopen the comment period for an additional 30 days beginning in March 2004. 
IFR Reference: p. 58894, column 1 

## How Do I Get a Copy of theInterim Final Rules?

_**[http://www.fda.gov/oc/bioterrorism/bioact.html](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**

**Notes:**
Talkpoints: The interim final rule can be accessed at the the web address listed on the screen
Or write to the FDA at the address listed on the screen

## How To Comment (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 Administration**
**5630 Fishers Lane, rm. 1061**
**Rockville, MD USA 20852**

## How To Comment(2 of 2)

**Submit electronic comments to:  **** **_**[http://](http://www.fda.gov/dockets/ecomments)**__**[www.fda.gov/dockets/ecomments](http://www.fda.gov/dockets/ecomments)**_** (no attachments); or**_**[FDADockets@oc.fda.gov](mailto:FDADockets@oc.fda.gov)**_** (with attachments)**** **
**YOU **_**MUST**_** INCLUDE THE DOCKET NUMBER:**
**2002N-0276 Registration**
**2002N-0278 Prior Notice**

## Compliance Policy – Exercise of Enforcement 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**

## 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)

**Registration of Food Facilities Interim Final Rule**
**68 FR 58894 (Oct. 10, 2003)**

**Notes:**
Talkpoints: Registration means that FDA for the first time will have the information we need to quickly locate and notify facilities that may be affected of a threat to food safety. 
IFR REFERENCE: p. 58894, column 1 

## Bioterrorism Act of 2002Section 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. **

## Overview of Registration Requirements

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

**Notes:**
Talkpoints: I will begin my discussion with a review of the new registration requirements.  I will provide a brief background then move on to explore the specifics of the new requirements.   I will end this first part of the presentation with a discussion of the consequences for not registering. 

## Who Must Register? 

**Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack,***** *****or hold food (subject to FDA’s jurisdiction) for human or animal consumption in the U.S. **
**Domestic facilities are required to register whether or not food from the facility enters interstate commerce**

**Notes:**
Talkpoints: Each domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the U.S. must be registered with the FDA by either its owner, operator, agent in charge or an individual they have authorized to register the facility. 
Therefore, the registration requirement is tied to, a facility that manufactures, processes, packs, or holds food; and if such food will be consumed in the US, either by humans or animals. 
If a facility is already registered with FDA or another government agency, they still have to register under this regulation.
Domestic facilities would be required to register whether or not food from the facility enters interstate commerce. 
 In the case of a foreign facility, the individual authorized by an owner, operator or agent in charge of a facility to register the facility could be its U.S. agent. 
IFR Reference: p 58894 column 3

## Who Must Register?(cont.)

**Owners, operators, or agents in charge may choose to authorize an individual to register on behalf of the facility**
**The requirement applies to each covered **_**facility**_**, *****not***** to firms or companies as a whole**
**E.g., company with 10 facilities must register each one separately**

**Notes:**
Talkpoints: Owners, operators, or agents in charge may choose to authorize an individual to register on behalf of the facility. 
The registration requirement applies to each covered facility, not to firms or companies as a whole. 
It is important to note that this a facility by facility registration requirement. For example, suppose one company has 100 facilities, each facility must register separately unless the facility falls under an exemption (which we will discuss shortly), because the requirement applies to each facility, rather than to each company as a whole.   
IFR Reference: p. 58894, column 2 

## U.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**

**Notes:**
Talkpoints: Owners, operators or agents in charge of a foreign facility must designate a US agent. 
A US agent can be any person that resides or maintains a place of business in the US and is physically present in the US. Thus, there are 2 requirements of a US agent, 1) they are a person, and 2) who lives in the US.  Person is defined as an individual, partnership, corporation, or association.
For example, a foreign facility can designate an importer, a broker, corporate trade association, or any person that resides or maintains a place of business in the US and is physically present in the US as their US agent.  The US agent cannot be a mailbox, answering machine or service nor any other place where the designated person is not physically present. 
FDA generally does not intend to hold a foreign facility's U.S. agent responsible for violations of the Bioterrorism Act that are committed by the foreign facility. FDA, however, would consider legal action against a U.S. agent where the agent knowingly submits false information to FDA or the U.S. agent and the foreign facility are effectively the same entity. Liability issues between the facility and its U.S. agent must be resolved between the private parties (i.e., the facility and its U.S. agent), most likely through the terms of their contractual relationship.
 IFR Reference: p. 58915, column 3

## 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)**

**Notes:**
Talkpoints: The US agent will act as a communications link between the FDA and the facility. The US agent will be contacted both for routine and emergency communications, unless the facility opts to designate a different emergency contact. In the proposed rule we required an emergency contact, we now assume that the emergency contact is the foreign facility’s US agent, unless they tell us otherwise. 
It is important to note that having a US agent  for FDA registration purposes does not preclude foreign facilities from having multiple agents for other business purposes. For example a foreign facilities sales business does not have to be done through their US agent. 
IFR Reference: p. 58915, column 3

## What Food is Subject to FDA’s 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.”  ****** ***

**Notes:**
Talkpoints: The food that is subject to FDA’s jurisdiction is defined in sec. 201 (f) of the Federal Food, Drug, and Cosmetic Act, which reads: articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article. 
IFR reference: p. 58908, column 1 

## What Food is Subject to FDA’s 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)**

**Notes:**
Talkpoints: Food contact substances, such as packaging materials and pesticides are not "food" for purposes of the interim final rule. So, a facility that manufactures/processes, packs, or holds a food contact substance or a pesticide is not required to register with FDA.
FDA found that it is reasonable to interpret the Bioterrorism Act as excluding food contact substances from the registration requirement. 
Also, pesticides are not included in the definition of food, because pesticides already are heavily regulated by the Environmental Protection Agency for health and safety purposes. 
IFR Reference: p. 58896, column 1

## Examples of FDA-regulated Food Within Scope of the Rule

**Dietary supplements and dietary ingredients**
**Infant formula**
**Beverages (including alcoholic beverages and bottled water)**
**Fruits and vegetables**
**Fish and seafood**
**Dairy products and shell eggs**

**Notes:**
Talkpoints: Examples of food includes, but is not limited to: dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), fruits and vegetables, fish and seafood, diary products and eggs.
IFR reference: p. 58908, column 1 

## 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**

**Notes:**
Talkpoints: Raw agricultural commodities for use as food or components of food, canned and frozen foods, bakery goods, snack food, and candy (including chewing gum), live animals foods, and animal feed and pet food. 
Please note that this is not an exhaustive list, rather it is used for illustration purposes. 
IFR reference: p. 58908, column 1 

## Registration Definitions

**Facility**** – **
**an establishment or structure(s) **
***under one ownership***** **
**at one general physical location **
**(or in the case of a mobile facility, traveling to multiple locations), **
**that manufactures/processes, packs, or holds**** ****food for *****human or animal***** consumption in the U.S.**
**A “facility” may be one food processing plant with multiple buildings in one location**

**Notes:**
Talkpoints: The term facility for registration purposes means: an establishment, structure, or structures under one management at one general location—or multiple locations in the case of a mobile facility—that manufactures/processes, packs or holds food for consumption by humans or animals in the U.S. 
Thus the requirement is tied to: 1) facilities, and 2) food that is consumed in the U.S. 
A facility may be one food processing plant with multiple buildings in one location.
IFR reference: p. 58900, column 1 

## “Facility” Definition(cont.)

**A building that has multiple companies at the same address would be considered 2 or more facilities**
**What is *****not***** a facility:**
**Transport vehicles ****if they hold food only in the usual course of business as carriers **
**A ****private residence**** of an individual **
**Non-bottled drinking**** water collection and distribution establishments**

**Notes:**
Talkpoints: Thus, a building that has multiple companies at the same address would be considered 2 or more facilities. 
However, not included in the definition of facilities are: food transport vehicles if they hold food only in the usual course of business as carriers, private residences of individuals, even though businesses may be conducted from them, and drinking water collection and distribution organizations and structures such as municipal water systems. However, this exception does not apply to bottled water facilities.
IFR Reference: p. 58904, column 1 

## 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**

**Notes:**
Talkpoints: The definition of manufacturing and processing is to make a food from one or more ingredients, and to synthesize, prepare, treat, modify, or manipulate food, including food crops or ingredients.
Examples are: cutting, peeling, trimming, washing, waxing, bottling, labeling, or packaging of food.
p. 58908, columns 1-3 

## Definitions (cont.)

**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**

**Notes:**
Talkpoints: Packaging means to place food into a container that directly contacts the food that the consumer receives. Packing here is used as a verb.
Packaging, as used here, is a type of manufacturing/processing activity, which must involve some sort of change to or manipulation of the food.
Simply placing produce into containers (such as clamshells, baskets, mesh bags, or plastic bags) without altering or manipulating food is more akin to packing, even if the containers are ultimately received by the consumer. 
Under § 1.227(b)(3)(i) of the interim final rule, a farm may engage in this packing activity so long as all of the involved produce is grown on the farm or a farm under the same ownership. Accordingly, a farm that simply places a raw agricultural commodity into containers such as clamshells is not “manufacturing/processing” and thus, is not “packaging” because the activity does not involve altering the form of the food.
Packing is to place food into a container other than packaging the food.
And holding means storage of food. For example, warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks would be considered a holding facility for registration purposes. 
p. 58912, column 1 
Registration Q and A Guidance Document, Question 2.10

## 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))**

**Notes:**
Talkpoints: Certain facilities are exempt from the registration requirement. These include: non-profit establishments, retailers, farms, restaurants, fishing vessels, except those that engage in processing as defined in FDA’s seafood regulations, and finally facilities that are regulated exclusively and throughout the entire facility, by the US Department of Agriculture. The UDSA regulates meat products, poultry products, and egg products. 
p. 58895, column 2 

## 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)**

**Notes:**
Talkpoints: Certain facilities are exempt from the registration requirement. These include: non-profit establishments, retailers, farms, restaurants, fishing vessels, except those that engage in processing as defined in FDA’s seafood regulations, and finally facilities that are regulated exclusively and throughout the entire facility, by the US Department of Agriculture. The UDSA regulates meat products, poultry products, and egg products. 
p. 58895, column 2 

## 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**

**Notes:**
Talkpoints: Nonprofit food establishments are charitable entities recognized under the US Internal Revenue Code as non-profit facilities, that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the U.S. This includes central food banks, soup kitchens, and nonprofit food delivery services. 
Again, a nonprofit food facility must meet the terms of section 501 (c) (3) of the US Internal Revenue Code to be excluded from registration requirements.
p. 58909, column 1 

## 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**

**Notes:**
Talkpoints: The definition of retail establishment was modified from the proposed rule, which stated that a retail establishment is an establishment that sells food products directly to consumers only. Under the interim final rule, a retail food establishment is an establishment that sells food products directly to consumers as their primary function, meaning that sales directly to consumers are of greater dollar value than sales to other buyers. 
Thus, a retail establishment may manufacture/process, pack, or hold food without registering, if the establishment's primary function is to sell the food directly to consumers from that establishment, including any food that it manufacturers/processes, packs, or holds, directly to consumers. 
Examples of retail food establishment are groceries, delis, roadside stands, etc.,
p. 58913, column 3 

## 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**

**Notes:**
Talkpoints: It is important to note that businesses are not considered consumers for purposed of defining a retail food establishment
Also, primary function is measured by annual sales to consumers, which must be greater than annual sales to non-consumers.
A business can choose when to begin/end its “annual” determination (e.g., fiscal year, calendar year are both acceptable).
P. 58913, column 3 

## 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**

**Notes:**
Talkpoints: A restaurant is a facility that prepares and sells food directly to consumers for immediate consumption.  This includes cafeterias, cafes,  fast food establishments, hospitals, nursing homes, or day care kitchens; and by analogy pet shelters, kennels and veterinary facilities that provide food directly to animals. 
This does not include facilities that provide food to interstate transport services, such as commercial aircraft, or central kitchens that do not prepare and serve food directly to consumers. 
p. 58913, column 2 

## 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**

**Notes:**
Talkpoints: A farm is a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals including seafood, or both. Washing, trimming of outer leaves, and cooling of produce are considered part of harvesting. 
This includes, apple orchards, dairy farms, feedlots, and aquaculture facilities.
Using chlorinated water to wash crops:
If water directly from a public or other water supply, considered washing and farm remains exempt
If chlorine is added>200 ppm, then the farm is engaged in manufacturing/processing and must register
If chlorine is added consistent with our Good Agricultural Practices Guidance at 50-200 ppm at a pH of 6.0-7.5, for contact time of 1-2 minutes, considered washing and farm remains exempt
Placing stickers on produce in and of itself does not cause a farm to lose exemption if the farm otherwise meets the definition.
Does applying pesticide to a crop require one to register?
If applied pre-harvest, part of farm; no registration is required
If applied post-harvest, is considered a manufacturing/processing activity – farm is exempt only if all food used in such activities is consumed on the farm or another farm under the same ownership
p. 58905, column 2 

## Farm Definition(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**

**Notes:**
Talkpoints: The term farm includes facilities that pack or hold food if all the food is grown or raised on that farm or consumed on that farm or another farm under the same ownership; or
A facility that manufactures/processes, packs or holds food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership.
Thus, a farm that performs  packing or holding activities will not necessarily cease to be a farm because the definition of farm includes facilities that pack or hold food, provided all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership. Thus, you can pack or hold food on your farm so long as the food that is packed or held is consumed on your farm or on another farm under the same ownership. 
For example, a farm can mix animal feed, which is a manufacturing and processing of food, as long as the feed is eaten on that farm or on another farm owned by the same farmer.
p. 58095, column 2 

## Allowable Farm Activities(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 fruit**
**Placing a raw agricultural commodity directly into consumer-ready packages **

## Additional Exemption for Some Foreign Facilities

**Foreign facilities**** that manufacture/ process, pack, or hold food are exempt if a subsequent **_**foreign**_** facility further ****manufactures/processes ****(including packages) the food, *****except***
**if the subsequent facility performs labeling or any similar activity of a *****de minimis***** nature, *****both***** foreign facilities must register**

**Notes:**
Talkpoints: All foreign facilities that manufacture/process, pack or hold food for human or animal consumption in the US must register. 
However, there is an exception. If food from a foreign facility undergoes subsequent manufacturing/processing by a second foreign facility, only the second facility is required to register. 
The question to ask is, are they making a finished food product? If so, the foreign facility must register. 
However, if the second facility’s manufacturing/procession is only de minimums, such as adding labeling to a package or putting plastic rings on beverage bottles to hold them together, then both foreign facilities are required to register. 
A foreign facility must also register if, prior to export to the United States, it packs or holds food after the last foreign manufacturer/processor of the food. 
For example, under these provisions, the last facility that manufactures/processes the cocoa beans, and every facility that subsequently engages in packing or holding the beans, as well as any facility that subsequently engages in de minimis manufacturing/processing, such as labeling, or the cocoa beans, is required to register. 
p. 58900, column 3 

## Foreign Facilities—Register or Exempt?

**Register:**
**Manufacturing/processing a **_**finished food**_** product**** **
_**Packing or holding**_** a food product or food ingredient**** **
**Exempt:**
**Manufacturing/processing a **_**food ingredient **_**that is subsequently further manufactured/processed outside the U.S. **

**Notes:**
Talkpoints: Again, a foreign facility is required to register if they manufacture or process a finished food product, or if they package or hold a food product or food ingredient. 
A foreign facility is not required to register if they manufacture or process a food ingredient that is subsequently manufactured/processed further outside the US
p. 58901, columns 2-3 

## “Mixed-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**

**Notes:**
Talkpoints: Some facilities may be mixed-type facilities, that is, some of their activities do not require registration and some do. Mixed-type facilities would have to register, unless all of the operations at the facility satisfy one or more exemptions in the IFR. 
An example would be a farm that grows oranges and processes them on-site into juice for sale to a distributor. This farm is required to register even though a farm is exempt, because the processing activity is subject to the rule. 

## “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**

**Notes:**
Talkpoints: A facility is exempt from registering only if ALL of its activities are included in one or more exemptions.
For example, suppose a farm sells the orange juice it produces to consumers at their own farm side stand, they would  be exempt under the farm exemption and under the retail exemption because they are selling orange juice directly to consumers as its primary function. 

## Two Types of Information:  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**

**Notes:**
Talkpoints: There are 2 types of information that are on the registration form, 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 food product categories on the registration. 
However, FDA encourages the submission of optional information to assist with communications with the facility.
p. 58925, columns 2-3 

##   What Information is Required? 

**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**

**Notes:**
Talkpoints: Each registration must include: the name and contact information for the facility and its parent company, the name address, and phone number of the owner, operator, or agent in charge, all trade names the facility uses.  
Trade name applies to the name or names under which the facility conducts business, or additional names by which the facility is known.
 A trade name is not the brand name a company uses, because a trade name is associated with a facility, and a brand name is associated with a product. 
p. 58922, column 1 

## What Information Is Required?(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)**

**Notes:**
Talkpoints: If a foreign facility, the name of and contact information for the facility’s US agent is required. As previously stated, foreign facilities can opt to include emergency contact information if they want someone other than their US agent to serve as the emergency contact. 
If a domestic facility, emergency contact information is required.  
FDA retained food product categories as specified in the Code of Federal Regulations (21 CFR 170.3) as an element of registration. This is because FDA believes that information about food product categories is necessary for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food related emergency. 
p. 58922, column 1 

## What Information Is Required? (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**

**Notes:**
Talkpoints: Also required is a statement certifying that the information submitted is true and accurate and that the person submitting the registration is authorized by the facility to register on its behalf 
Again, you cannot register unless you are the owner, operator, or agent in charge of a facility or someone authorized by the owner, operator or agent in charge  to submit registration information to FDA. If the submitter is not the owner, operator, or agent in charge, they must also provide the name and contact information of the individual who authorized submission of the form. 
p. 58925, column 1 

## 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 **

**Notes:**
Talkpoints: The optional information will help us communicate more effectively with facilities that may be the target of an actual or potential terrorist threat or other food-related emergency, which will benefit both FDA and the registered facility. 
For example, some food products are not covered in the Code of Federal Regulations list of food product categories, such as certain dietary supplements, infant formula, and animal feed, but foods in these categories may be the focus of a food-related emergency. Therefore, FDA encourages, but does not require, submission of the information identified as optional.
Optional information includes: fax number and e-mail address of the facility, preferred mailing address, type of activity, such as manufacturer/processor, title, fax number, and e-mail address of the US agent, and type of storage.
p. 58925, columns 2-3

## 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**

**Notes:**
Talkpoints: Additional food product categories not specified in 21 CFR 170.3, such as dietary supplements, infant formula, and animal feed are also optional. 
Most/all food product categories (As opposed to mandatory food product categories) is also optional
Approximate dates of operation, if seasonal, is also optional information 
p. 58925, columns 2-3 

## 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**

**Notes:**
Talkpoints: Other optional information includes: 
 the fax number and e-mail address of the owner, operator, or agent in charge; 
 for domestic facilities the fax number and email address of the parent company, and the emergency contact name, title and e-mail address;
 and for foreign facilities the emergency contact name, title, phone number, and e-mail address. 
p. 58925, columns 2-3 

## How 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**

**Notes:**
Talkpoints: Registrants must use Form 3537 to register. The registration may be done online via the Internet at www.fda.gov/furls, which operates continuously 24 hours a day and seven days a week worldwide where ever Internet access is available. 
FDA strongly encourages online registration. This is because online registration is the least costly and most efficient means of registering both for all these facilities as well as FDA. 
Electronic registration will not allow registration to be submitted until all mandatory fields are completed. Therefore if a mandatory field is left incomplete on the online registration form, a facility will become aware of this instantly, and can make necessary changes.
On-line registration should take no more than 15 minutes to complete.
Help menus, tutorials, and personnel at FDA’s Help Desk will be available to assist in registration. 
p. 58919, column 1 

## How 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)**

**Notes:**
Talkpoints: Electronic registration will also provide automatic receipt of registration and facility’s registration number. 
Again, the web site is available from wherever the Internet is accessible, including libraries, copy centers, schools, and Internet cafes. The FDA strongly encourages electronic registration. 
It is important to note that an authorized individual can register a foreign facility on behalf of the owner, operator, or agent in change. For example, a US agent can register a foreign facility if authorized to do so.
P. 58920, column 2 

## 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**

**Notes:**
Talkpoints: Registration can also be done on a paper form available from the FDA. But, again, the FDA strongly encourages electronic submission. Paper registration will require a more costly and less efficient process to supply both FDA with the necessary facility information and facilities with their registration numbers. 
Paper registrations will also lead to a much slower process. Those who submit a paper registration form need to ensure the 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. 
p. 58918, columns 2-3 

## Costs and Frequency of Registration

**No registration fee**
**Registration is one-time, not annual**

**Notes:**
Talkpoints: FDA does not charge a fee for registration or for updates of any registration 
Also, registration is required once and only once for each food facility
FDA is aware that various firms may be offering their services to assist domestic and/or foreign facilities to register with FDA and/or to serve as their U.S. Agent. 
None of these firms are affiliated with FDA, nor has the agency contracted with any firms to register facilities. 
FDA does not endorse or recommend anyone to serve as U.S. Agent or to register facilities – this is a private matter between parties, and as with all other areas of business, we encourage facilities to shop wisely (e.g., talk to fellow businesses, trade associations, etc. for recommendations)
p. 58918, column 1 

## 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**

**Notes:**
Talkpoints: When a facility’s mandatory information changes, for example, closure of the facility, new ownership, or a change in contact information, FDA must be notified within 60 days of the change through www.fda.gov/furls or the paper registration process. 
FDA encourages timely updates of optional information previously submitted to assist FDA in keeping its database current in order to respond to emergencies.
 p. 58927, column 2 

## 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**

**Notes:**
Talkpoints: If a facility is required to cancel its registration, the owner, operator, or agent in-charge of the facility, or an individual authorized by them must do so within 60 days of the reason for cancellation. 
For example, if a facility ceases operations, ceases food for consumption in the U.S., or the facility is sold to a new owner, the facility must cancel its registration within 60 days of the reason for cancellation.
p. 58929, column 2 

## 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**

**Notes:**
Cancellation may be done electronically or by mail. 
Cancellation must include the following information: facility’s registration number, whether the facility is domestic or foreign, facility name and address, the names and address of the individual submitting the cancellation, and a statement certifying that the information is true and accurate and that the person is authorized to submit the cancellation. 
p. 58928, column 1 

## Where to Register, Update or Cancel a Registration

**Electronically:  **_**[http://www.access.fda.gov](http://www.access.fda.gov/)**__** **_
**Request a paper copy by mail or phone:****U.S. Food and Drug Administration (HFS-681)****5600 Fishers Lane****Rockville, MD, USA   20857****877 332-3882**
**Ask for Form 3537 to register or update**
**Ask for Form 3537a to cancel a registration**

## Slide 56

**Notes:**
Talkpoints: Shown on the screen is the FDA website. In order to make submission into the database, each facility is required to create an account. Once a facility opens an account, they simply enter in their account ID and password to access it. 
Keypoint: Passwords are case-sensitive. Please remember your password once you create it (one of the biggest problems users have).

## Slide 57

**Notes:**
Talkpoints: Shown on the screen is the food facility registration module. Here, a facility can register their facility, update their registration, and cancel or change registration status. 

## Confidentiality of Registration Information

**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.  **

## Registered 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**

## Slide 60

## 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**

**Notes:**
Talkpoints: The Bioterrorism Act makes failure of a domestic or foreign facility to register, update, or cancel its registration in accordance with this regulation a prohibited act.
This means the Federal government can bring a civil action to ask a Federal court to direct persons who commit a prohibited act to cease, or it can bring a criminal action in Federal court to prosecute persons who commit a prohibited act. 
p. 58928, column 2 

## Consequences of Failure to Register  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)**

**Notes:**
Talkpoints: If a foreign manufacturer fails to register, the food is subject to refusal for failure to provide adequate prior notice.
It is important to note that registration for foreign facilities will be enforced through prior notice. 
p. 58929, column 1 

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

## Intermission!

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

## An Overview of the 
Prior Notice of Imported Food
Interim Final Rule
68 FR 58974 (Oct. 10, 2003)

**Prior Notice of Imported Food**
**Interim Final Rule**
**68 FR 58974 (Oct. 10, 2003)**

**Notes:**
Talkpoints: 
This interim final rule requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. 
The interim final rule implements section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires prior notification of imported food to begin on December 12, 2003, even in the absence of a final regulation 
IFR REFERENCE: p. 58894, column 1 

## Bioterrorism Act of 2002Section 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**

## Overview of Prior Notice Requirements

- <date/time>

**Overview of Prior Notice Requirements**

**Points to Cover**
**The Current Import Process**
**The New Process (Prior Notice)**
**Definitions**
**Exemptions**
**How to Submit Prior Notice**
**What Information is Required**
**Consequences of Inadequate Prior Notice**

**Notes:**
Talkpoints:

## The Current Import Process

- <date/time>

**The Current Import Process**

**Information:**
**	****Filer****	****	****	****Importer****	****	**
**	****Consignee****	**** ****	****Manufacturer****	**
**	****Product****	****	****	****HTS code**
**	****Quantity****	****	****Country of Origin**
**	****Value****	****	****	****Carrier information**
**	****Entry type****	****	****Entry Number**
**	****Arrival date****	****	****Port of Entry**
**	****	****	****	****. . .  and more**

**Notes:**
Talkpoints: Currently, much of the same information that is required under prior notice is already being submitted through Customs. Currently, the filer, consignee, product, quantity, value, entry type, arrival date, importer, manufacturer, HTS code, country of origin, carrier information, entry number, port of entry, and more is required upon entry into the US

## The Current Import Process

- <date/time>

**The Current Import Process**

**Information 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 FDA**
**	****FDA Product Code, Affirmations of Compliance, FDA Country of Origin, Manufacturer, and Shipper**

**Notes:**
Talkpoints: Under the current import process, information is provided to CBP regarding entry. Ninety eight per cent of this information is submitted electronically through customs’ Automated Broker Interface (ABI) of the Automated Commercial System (ACS) by the customs broker.
The same information is then forwarded to FDA electronically to OASIS by CBP
Additional information is provided to the FDA. This includes the FDA product code, affirmations of compliance, FDA country of origin, manufacturer, and shipper information. 

## The Current Import Process

- <date/time>

**The Current Import Process**

**Evaluated by FDA**
**electronic screening**
**human assessment**
**Admissibility decision by FDA**
**electronically from FDA to CBP to broker**
**Notices (paper) to importer**

**Notes:**
Talkpoints: This information is evaluated by the FDA by electronic screening and human assessment 
An admissibility decision is then made by the FDA. This is done electronically from FDA to CBP to the broker. A paper notice is then sent to the importer. 

## The Current Import Process

- <date/time>

**The 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 air**
**at arrival if by land**

**Notes:**
Talkpoints: Under the current import process, maximum prior time for arrival is set by CBP according to the mode of transportation. 
CBP and FDA screening response is sent no more than 5 days before arrival if by sea; no sooner than wheels up if by air; and at arrival if by land. 

## PRIOR NOTICE OF IMPORTED FOOD

**THE NEW IMPORT PROCESS**
**beginning Dec. 12, 2003**

**Notes:**
Talkpoints: The new prior notice import process will begin on December 12, 2003.
This means that before food is imported to the US, beginning on December 12, 2003 certain information must be provided to the FDA. 

## The New Import Process (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**

## The New Import Process (Prior Notice)

_**New Procedures**_
**Information screened by FDA**
**Regardless of source (CBP or PNSI)**
**Electronically**
**Additional FDA staff assessment**
**24/7**
**Centrally located**

## Prior 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. **

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

- <date/time>

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

**Notes:**
Talkpoints: If an entry is not examined at the border, it may be examined or sampled at an inland location or or the importer’s premises or public storage
Routine notices will follow the decision to examine or sample. 

## FDA’S Prior Notice:Definitions

- <date/time>

**FDA’S Prior Notice:****Definitions**

**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**

**Notes:**
Talkpoints: Some definitions that pertain to the prior notice rule are: international mail, which is defined as foreign national mail services. This definition expressly excludes express carriers, express consignment operators, or other private delivery services, such as UPS and Federal Express.
 Port of arrival is the water, air, or land port at which the article of food is imported or for import into the US, such as the port where the article of food first arrives in the US. It is important to note that this may be different from the port where food is entered for CBP purposes. 
p. 58987, column 3 & p. 58988, column 1 

## Port of Arrival vs. Port of Entry

- <date/time>

**Port of Arrival vs. Port of Entry**

**Crossing Location = Port of Arrival for Prior Notice; may or may not be the port where entry is made for CBP purposes**

**Notes:**
Talkpoints: Prior notice must contain the anticipated port of arrival, or the port where food first arrives in the US. This may or may not be the port where the article is entered. 
For example, in this illustration the article arrives and crosses the border in California, which would be the port of arrival,  but it is not entered for CBP purposes until it reaches Oklahoma, which would be the port of entry. It is important for FDA to be able to inspect the food where it crosses the border if FDA deems necessary, rather than after it has been transported throughout the country. 
It is worth noting that whenever an article of food crosses the border, some type of CBP entry must be filed, even if it is an in-bond entry, a warehouse entry, or other type of non-consumption entry. But under the current system, FDA may not examine the in-bond food until it arrives at the CBP port of entry or the importer’s premises, which may be a considerable distance away.
The port of arrival definition gives FDA the greatest ability to identify and protect the United States from potential intentional adulteration by enabling FDA to hold and examine shipments as FDA deems appropriate.
p. 58988, column 1

## FDA Country of Production(Originating Country)

- <date/time>

**FDA Country of Production****(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.**

**Notes:**
Talkpoints: The country of production for food in its natural state is the place where the article of food was grown or collected, including harvested and readied for shipment to the US. Please note that the term country of production replaces the term originating country in the proposed rule. 
The country of production for wild fish or seafood caught or harvested outside the waters of the US by a vessel that is not registered in the US is the county in which the vessel is registered. 
The country of production for an article of food that was grown in a US territory is the US.
p. 58983, column 1 

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

- <date/time>

**FDA Country of Production ****vs. 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**

**Notes:**
Talkpoints: For example, for beans that are grown and dried in the US, then rehydrated and canned in Country D, CBP identifies the country of origin as the US, because the US is the country where the article of food was grown. 
For purposes of prior notice, FDA identifies the article of food as canned beans rather than dried beans. Thus, the FDA Country of Production is Country D, because this is where the last significant activity is done. 
From a food safety standpoint, FDA is most interested in knowing where the article of food was processed and canned. FDA believes it best serves the language and the purposes of section 801 (m)(1) of the FD &C Act to define the term to focus on the country of production of the specific article of food that is being shipped to the United States.  
p. 58983, columns 1-3 

## FDA’S Prior Notice: Definitions

- <date/time>

**FDA’S Prior Notice: ****Definitions**

**Shipper**** ****–**** ****t****he 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) **

**Notes:**
Talkpoints: The shipper is the owner or exporter of the article of food who sends and ships the article from a foreign country or the person who sends an article of food by international mail to the US 
The United States includes the Customs territory of the United States, which includes the 50 states, the District of Columbia, and the Commonwealth of Puerto Rico, but not the Territories. 
Note that the definition of “domestic” (i.e., “United States”) in the Registration IFR is different than the definition of “United States” in the Prior Notice IFR.
For Registration – domestic means any part of the United States, including the territories.  
For Prior Notice – United States means the Customs Territories, which excludes territories.
p. 58988, column 3 

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

- <date/time>

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

| Tuna | 24/12 oz cans | 2000 cases | Company 1 |
| --- | --- | --- | --- |
| Tuna | 48/6 oz cans | 1000 cases | Company 1 |
| Tuna | 24/12 oz cans | 300 cases | Company 2 |
| Tuna | 6/66oz cans | 2400 cases | Company 3
 |

***1 Shipment; 4 different products; 4 prior notices**

**Notes:**
Talkpoints: Suppose a facility has one import shipment containing canned tuna from four different manufacturers.
The regulation applies to each article of food that is imported or offered for import into the United States, even if several food articles are contained in a single shipment, or container, or entry. 
Each lot of canned tuna, or each article of food, in the displayed shipment will require a separate prior notice submission, because it is associated with a different manufacturer and/or different packaging size.
Therefore, this one shipment, containing four different products will require four prior notice submissions, just as four different entries are made with CBP.

## What Food Imports are Subject to Prior Notice?

- <date/time>

**What Food Imports are Subject to 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**

**Notes:**
Talkpoints: The prior notice regulation applies to all food for humans and other animals that is imported into the United States. Prior notice is required for food for use, storage, or distribution in the United States, and includes food for gifts, trade samples and quality assurance/quality control samples, food imported for future export. Prior notice is tied to food coming into the United States for any reason. Unlike registration requirements, prior notice is not tied to consumption in the U.S.
It is important to note that unlike registration requirements, food from farms is subject to prior notice requirements. While registration relates to facilities that perform certain operations on or related to foods, prior notice relates to the food itself. Prior notice is required for all food and feed articles that are under FDA’s jurisdiction and are imported into the United States, regardless of an article’s source or intended recipient. Prior notice is required, therefore, even if the food is a farm product. 
   There are no exceptions for prior notice for:
   food items of small value or quantity, food samples for R & D or testing purposes only, but not for consumption; nor food samples for test marketing.
p. 58984, column 1 ; Prior Notice Question and Answers

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

- <date/time>

**What Food Imports are Subject to 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 **

**Notes:**
Talkpoints: Food for transshipment through the United States to another country requires prior notice submission. For example, if apples are transported from Canada, through the US, to Mexico and there is no US importer or purchaser, prior notice is required. Transport through the United States is an importation into the United States. Therefore, notice would be required in advance of importation. Prior notice is required whether or not the food is intended for consumption on the US. 
Food for use in a US foreign trade zone, food sent by mail, and food sent by express couriers are also subject to prior notice requirements.  
p. 58984, column 1 

## What Definition of “Food” Applies?

- <date/time>

**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.”******  ****** ***

**Notes:**
Talkpoints: Food is defined in section 201 (f) of the Federal Food, Drug, and Cosmetic Act as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles, however, there are exceptions to this definition. 
p. 58984, column 1 

## Examples of FDA-regulated Food Within Scope of the Rule

- <date/time>

**Examples of FDA-regulated Food Within Scope of the Rule**

**Dietary supplements and dietary ingredients**
**Infant formula**
**Beverages (including alcoholic beverages and bottled water)**
**Fruits and vegetables**
**Fish and seafood**
**Dairy products and shell eggs**

**Notes:**
Talkpoints: Examples of FDA regulated food within the scope of the rule are: dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), fruits and vegetables, fish and seafood, diary products and shell eggs, 
p. 58984, column 1

## Examples of FDA-regulated Food Within Scope of the Rule

- <date/time>

**Examples of FDA-regulated Food Within Scope of the Rule**

**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**

**Notes:**
Talkpoints: Raw agricultural commodities for use as food or components of food, canned or frozen foods, live food animals, bakery goods, snack food, candy, and chewing gum, and animal feeds and pet food. 
Please note that this is not an exhaustive list, rather it is used for illustration purposes. 
p. 58984, column 1

## What is Excluded from the Prior Notice Food Definition

- <date/time>

**What is Excluded from the Prior Notice 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**

**Notes:**
Talkpoints: Food contact substances, such as packaging materials and pesticides are not "food" for purposes of the interim final rule. So, prior notice to FDA is not required for food contact substance or a pesticide.
Meat, poultry, and egg products that at the time of importation are subject to USDA’s exclusive jurisdiction are also excluded from the prior notice food definition. 
p. 58987, column 2 

## What Kinds of Food Imports are Not Subject to Prior Notice? 

- <date/time>

**What Kinds of Food Imports are **_**Not**_** 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.**

**Notes:**
Talkpoints: The interim final rule would not require PN for food that travelers bring to the U.S. in their personal baggage, provided the food is for their personal use, that is consumption by themselves, family, or friends.
If, however, a traveler is bringing food into the U.S. in their personal baggage and it is not for their personal use, for example, it is for sale to another or for use as a sample, then the interim final rule would require the traveler to provide PN.
Also, if an individual buys food at the store and sends it to the US, she is subject to prior notice, because foods that arrive by international mail are subject to prior notice requirements. 
p. 58990, column 1 

## What Kinds of Food Imports are Not 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**

**Notes:**
When it comes to articles that are imported then exported directly from their port of arrival, FDA concludes that it is reasonable to interpret the term “imported or offered for import” to exclude them from the prior notice requirements.
Food that is brought to a U.S. port but is then directly exported from that port of arrival is entered under a CBP Importation for Exportation (IE) entry and subject to the limitations of an IE bond. In essence, this food may not leave the port of arrival until export.
These imports are thus subject to almost identical restrictions as food that is refused under section 801 (m)(1) of the FD&C Act—foods that are imported under an IE entry may not leave the port of arrival unless exported.
Given that controls already exist to ensure that these aricles are not released from the port of arrival, FDA believes that it is reasonable to interpret 801 (m) as excluding these imports from section 801 (m) of the FD&D Act’s prior notice requirements.
 PN is not required for food brought into the US in a diplomatic pouch, because under the Vienna Convention on Diplomatic Relations, a diplomatic pouch shall not be opened or detained.
There are no exceptions for prior notice for:
		food items of small value or quantity, Food samples for R&D or testing purposes only, but not for consumption; nor Food samples for test marketing.

## Comparison of “Food” for Registration 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)**

## Who is Authorized to Provide Prior Notice?

- <date/time>

**Who is Authorized to Provide 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 **

**Notes:**
Talkpoints: The provision that pertains to who can submit prior notice has been revised. The interim final rule has been revised to remove the restriction that the submitter be the US importer or purchaser. 
Under the interim final rule, prior notice may be provided by any person with knowledge of the required information. Thus, any person may now take responsibility for submitting prior notice for a particular article of food, as long as that person can provide the required information. This person is referred to as the submitter in the interim final rule. 
The submitter may use another person to transmit the required information to FDA. The person who transmits the prior notice is referred to as the transmitter. 
If the submitter submits and transmits the prior notice, he or she is both the submitter and the transmitter. 
p. 58994, column 2 

## How Do I Submit Prior Notice?

- <date/time>

**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](http://www.access.fda.gov/)**__** **_

**Notes:**
Talkpoints: The interim final rule provides that prior notice must be submitted in English using the Latin alphabet except for the individual’s name, the name of the company, and the name of a street may be submitted in a foreign language. 
In addition, prior notice must be submitted electronically through either through CPB’s Automated Broker Interface (ABI) of the Automated Commercial System (ACS) for ABI filers, or using FDA’s Prior Notice System Interface (PNSI) at the address listed on the screen. For prior notices that cannot be submitted through CBP’s ACS, the FDA’s Prior Notice System Interface (PNSI) can be used by anyone with the required prior notice information. 
Both systems will be available 24 hours a day, and 7 days a week beginning December 12th, 2003. 
The difference between CBP’s ACS system and FDA’s PNSI is that ACS is a system that only authorized licensed users may access. 
The FDA PNSI, on the other hand, is an Internet-based system that permits anyone to submit the required prior notice information
FDA expects approximately 90 percent of prior notice submissions for all importations of foods to be transmitted by a customs broker or self-filer through the ABI/ACS interface to FDA. FDA estimates that only 10 percent of the total importations cannot be accommodated by the ABI/ACS interface, and, therefore will be submitted via the FDA PN System Interface. 
p. 58996, column 1 

## Submitting Prior Notice (cont.)

- <date/time>

**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**

**Notes:**
Talkpoints: FDA’s Prior Notice System Interface submission is required for: articles of food imported or offered for import by international mail, transaction types that cannot be made through ABI/ACS, and articles of food that have been refused for inadequate prior notice.
p. 59000, column 2 

## <date/time>

**Notes:**
Talkpoints: Shown on the screen is the FDA website. Here, a facility can both register their facility and submit the appropriate prior notice. There is also a help button for assistance when you are in the process of completing these forms. 
You can access this web site at www.access.fda.gov/ 

## Submitting Prior Notice (cont.)

- <date/time>

**Submitting Prior Notice (cont.)**

| 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) |

**Notes:**
Talkpoints: If customs broker’s or self-filer’s system, or CBP’s ABI/ACS is not working, then prior notice must be submitted electronically to the FDA Prior Notice System Interface. 
If the FDA  Prior Notice System Interface is not working, then the required information must be submitted by fax or email to the prior notice contact number and address posted on FDA’s website listed on the screen. 
p. 59000, column 2 

## Submitting Prior Notice (cont.)

- <date/time>

**Submitting Prior Notice (cont.)**

| 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 fax****if FDA determines PNSI or OASIS is not working**

**Notes:**
Talkpoints: If the OASIS system is not working, then prior notice must be submitted by fax or email to the prior notice contact number and address posted on the FDA’s website. 
It is important to note that prior notice will only be accepted by e-mail or fax if FDA determines that PNSI or OASIS is not working. All other submissions must be made electronically.
Note: PNSI is not on the same platform as FDA’s web system. Thus, FDA can post notices that are accessible to the public PNSI is not operational.
p. 59000, column 2 

## When Is My Prior Notice Due?

- <date/time>

**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**

**Notes:**
Talkpoints: The provision for when prior notice must be submitted to FDA has been significantly revised. FDA had proposed that all information required in the prior notice be submitted to FDA no later than 12 noon of the calendar day before the day the article of food arrived at the border crossing in the port of entry. 
Under the interim final rule,when prior notice is due is tied to the mode of entry.  Except of food arriving by international mail, prior notice cannot be submitted more than 5 days before arrival, which is a limitation in the Bioterrorism Act. 
Prior notice must be submitted to FDA and confirmed for FDA review no less than 2 hours before arrival by land via road, and no less than 4 hours before arrival by air and land via rail. 
p. 58995, column 1 

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

- <date/time>

**When Is My Prior Notice Due? (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**_

**Notes:**
Talkpoints: And prior notice must be given no less than 8 hours before arrival by water. It is important to note that these times are not the same as the carrier times used by CBP. 
When an article of food that is carried by or otherwise accompanies and individual is subject to prior notice, the prior notice must be submitted within the timeframe established for the mode of transportation. 
If the article of food is arriving by international mail, the prior notice must be submitted before the food is mailed to the United States and a copy of the prior notice confirmation must accompany the package.
p. 58995, column 1 

## What Information is Required in a Prior Notice?

- <date/time>

**What Information is Required in a 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)**

**Notes:**
Talkpoints: The interim final rule requires the following information to be submitted in the prior notice: Identification of the submitter, including name, telephone and fax numbers, email address, and firm name and address; Identification of the transmitter, if different from the submitter, including name, telephone and fax numbers, email address, and firm name and address; Entry type and CBP entry number or other CBP identification number.
p. 59000, column 1 

## What Information is Required in a Prior Notice?

- <date/time>

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

**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**

**Notes:**
Talkpoints: The identification of the article of food, including complete FDA product code, the common or usual name or market name, the estimated quantity described from the smallest package size to the largest container, and the lot or code numbers or other identifier if required by FD &C Act or FDA regulations. Examples of foods requiring lot numbers include low acid canned foods, infant formula, and acidified foods.
p. 59003, column 2 

## What Information is Required in a Prior Notice?

- <date/time>

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

** † ****indicates n****ot 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**

**Notes:**
Talkpoints: For food no longer in its natural state, manufacturer and registration number. 
However, this is not required for food sent by individual as personal gift. The prior notice an contain the manufacturer’s name and address as stated on the label.
For food in its natural state, the grower is to be provided, if known
The FDA country of production
p. 59007, column 2 

## What Information is Required in a Prior Notice?

- <date/time>

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

**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**

**Notes:**
Talkpoints: The identification of the shipper. This includes the name of the shipper and the registration number. 
The country from which the article of food is shipped 
The anticipated arrival information, including the location, date and time of arrival. Or, if the food is imported by international mail, the US recipient, including their name and address. 
p. 59008, column 1 

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

- <date/time>

**What Information is Required in a 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*****†**

**Notes:**
Talkpoints: The name and address of the importer 
The name and address of the owner, if different than the importer or ultimate consignee
The name and address of the ultimate consignee
p. 59010, column 1 

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

- <date/time>

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

**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**

**Notes:**
Talkpoints: The mode of transportation
The identification of the carrier, using the Standard Carrier Abbreviation Code (SCAC) or the International Air Transportation Association (IATA) code carrying  the food from the country from which it is shipped. 
The Harmonized Tariff Schedule code  is also required in a prior notice submission 
p. 59011, columns 2-3 

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

- <date/time>

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

**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**

**Notes:**
Talkpoints: And finally, the planned shipment information is required. All modes of transportation are to include the airway bill number or bill of lading number, and container number if containerized cargo. 
For vessels, the vessel name and voyage number is required 
For air arrival, the flight number is required 
For arrival by road, the trip number is required 
For arrival by rail, the car number is required
And for arrival by private vehicle, the license plate number and state/province is required. 
p. 59012, column 1 

## Requirements for Food Arriving by International Mail

- <date/time>

**Requirements for Food Arriving by International 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**

**Notes:**
Talkpoints: For food arriving by international mail, all information previously listed is required except for: anticipated port, date, and time of arrival, importer, owner, or ultimate consignee, mode of transport, carrier and planned shipment information, and HTS code. 
For food arriving by international mail additional information is required. The interim final rule requires the identification of the recipient by name and address and the date of shipment.  
p. 59012, column 2 

## Requirements for Food Refused for Inadequate Prior Notice

- <date/time>

**Requirements for Food Refused for Inadequate Prior Notice**

**All information previously listed, *****except*****:**
**Anticipated port, date, and time of arrival**
**Additional information required:**
**U.S. recipient**
**Hold location**

**Notes:**
Talkpoints: If food is refused for having inadequate prior notice, all information previously listed is required except for the anticipated port, date, and time of arrival.
 For food refused for having inadequate prior notice, additional information is required. This includes the US recipient, and where the food is being held.
p. 59012, column 2 

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

- <date/time>

**What Happens When FDA 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**

**Notes:**
Talkpoints: When FDA accepts your prior notice for review, FDA will notify the transmitter that prior notice has been confirmed for review with a reply message containing a prior notice confirmation number. This takes about 15 minutes. 
The prior notice clock, in terms of timeliness of notice, starts to when FDA confirms prior notice. Therefore, when FDA confirms prior notice, the 2,4, or 8 hour clock starts ticking.  
It is important to note that receipt of confirmation does not necessarily mean that FDA has determined that prior notice is timely and accurate or that the food will be admitted.
p. 58999 column 2

## Prior Notice Confirmation Number Must Accompany . . .

- <date/time>

**Prior Notice Confirmation Number 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**

**Notes:**
Talkpoints: The prior notice confirmation number must accompany the following. 
Any article of food arriving by international mail, and the number must be on the Customs Declaration; food brought in by individuals for non-personal use.
Any article of food for which prior notice was submitted through PNSI when the article arrives in the US; and the confirmation number must be provided to CBP or FDA upon arrival. 
P. 59000, column 1 

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

- <date/time>

**What if the Information Changes 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**

**Notes:**
Talkpoints: If a change is made to estimated quantity, anticipated information, planned shipment information, or estimated date of mailing, no action is required. 
For all other changes, prior notice must be resubmitted. Transmitters should also cancel the prior notice previously submitted through either PNSI or ABI/ACS depending on how the original prior notice was filed. Also, the timeframe will restart. 
For example, suppose at the last minute, a supplier decides to substitute the same food product (e.g. crackers) but from a different manufacturer. The supplier must submit a new prior notice to cover the crackers consistent with the timeframe required by the mode of transportation. 
p. 59012, column 3 

## What Happens to Food Without Adequate Prior Notice?

- <date/time>

**What Happens to Food Without 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**

**Notes:**
Talkpoints: If prior notice is inadequate or missing, then the food is subject to refusal of admission into the United States. 
Any inadequate PN submission will not receive an electronic confirmation number.  If further manual review determines that the PN is inadequate, then the shipment will be refused entry until proper PN has been supplied, consistent with the time period corresponding to the arrival mode of transportation. 
If a shipment arrives without prior notice or inadequate prior notice, and it is being held, prior notice can still be submitted as long as it is consistent with the time period corresponding to the arrival mode of transportation. 
If prior notice is untimely, food is subject to refusal, unless FDA has already reviewed the notice and notified CBP of its response.
P. 59016, columns 1-2 

## What Happens to Food Without Adequate Prior Notice?

- <date/time>

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

**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**

**Notes:**
Talkpoints: Food lacking PN must be held at the port of entry unless FDA directs its removal to a secure facility. The Bioterrorism Act is quite clear that if no notice is received regarding a food importation, it shall be refused and may not be delivered to the importer, owner, or consignee under a delivery bond. 
This is an important point because prior to this rule’s implementation, every shipment is conditionally released by CBP to the importer or the importer’s agent once it arrives at a port of entry and prior to FDA making an admissibility assessment. 
This demonstrates the importance of importers, owners, consignees, and brokers understanding the significance of failing to provide PN on a food importation. 
If food is refused, the FDA must be notified of the hold location. 
All transportation and storage expenses will be borne by the purchaser, owner, importer, and/or consignee. The FDA and CBP are not liable for these expenses.
p. 59021, column 2 

## What Happens to Food Without Adequate Prior Notice?

- <date/time>

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

**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**

**Notes:**
Talkpoints: A refused food is considered general order merchandise under 19 USC 1490 of the Tariff Act . The refused food must be moved under an appropriate custodial bond. 
If the food is held, it must be taken directly to the designated location within 48 hours. Refused food must not be entered with CBP, and it must not be delivered to importer, owner, or ultimate consignee until prior notice requirements are met. 
p. 59019, column 2

## Consequences of Failure to Submit Adequate Prior Notice

- <date/time>

**Consequences of Failure to Submit Adequate 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**

**Notes:**
Talkpoints: Importation to the United States of food without prior notice is a prohibited act. This means the Federal government can bring a civil action to ask a Federal court to direct persons who commit a prohibited act to cease, or it can bring a criminal action in Federal court to prosecute persons who commit a prohibited act. 
FDA can seek to debar persons under section 304 of the Bioterrorism Act. 
p. 59022, column 1 

## Consequences of Failure to Register  If Required

- <date/time>

**Consequences of Failure to Register  ****If 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**

**Notes:**
Talkpoints: If failure to register relates to the manufacturer, the food is subject to refusal for failure to provide adequate prior notice. For example, if the identity of the facility is incomplete, the food is subject to refusal for failure to provide adequate prior notice. 
Also, if failure to register relates to the manufacturer, the same consequences for inadequate prior notice apply. 
Note: Prior Notice does not capture the registration numbers of all facilities associated with the imprinted food that are required to register. Only the manufacturer’s and shipper’s registration numbers are required in a prior notice.
p. 59021, column 1 

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

- <date/time>

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

**If the failure relates to ****another facility**** associated with the food that is not registered:  ****food is subject to hold**** at the port of entry or other location if directed by FDA or CBP**
**Food remains under hold until facility is registered and number provided to FDA**

**Notes:**
Talkpoints: If the failure to register relates to another facility associated with the food that is not registered, the food is subject to hold at the port of entry or other location if directed by FDA or CBP
The food will then remain under hold until the facility is registered and a registration number is provided to FDA
p. 59016, columns 1-3

## FDA-CBP JointImplementation Plan

- <date/time>

**FDA-CBP Joint****Implementation 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**

**Notes:**
Talkpoints: In March of 2004, the FDA and CBP will publish a plan and implementation schedule to achieve the goal of a uniform, integrated system and coordinate timeframes for implementing prior notice information with other information transmitted to CBP.
Also, to ensure that those commenting on this interim final rule have had the benefit of FDA's outreach and educational efforts and have had experience with the systems, timeframes, and data elements of this interim final rule, the agency intends to reopen the comment period in March 2004 for an additional 30 days once we publish the plan.
58995. column 2

## Compliance 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**

**Notes:**
FDA will be providing industry and the public with summary information about the level of compliance with the prior notice requirements, including data on the types of errors in submitted prior notices.  
This information will also be analyzed to help FDA take appropriate enforcement action when necessary.
Information of interest to industry and other members of the public falls into two categories:
Information of general interest about the number and  types of prior notices that are being filed, and which systems are being used to submit them 
Information about the degree of compliance with the prior notice requirements 
The first posting of summary information describes prior notice submissions received during the first two months after the interim final rule became effective December 12, 2003.  It provides a high level summary of the current pattern of submissions, and identifies the biggest areas of concern.  
As the transition period progresses, FDA expects to provide more detailed information that will specifically target key areas that require attention.

## Prior Notice Submission By Source

**Prior Notice Submission By Source**

**Blue:  PNSI**
**Green:  ACS**

**Notes:**
As shown in the accompanying graph, FDA received more than 140,000 prior notice submissions each week during February.  
About  88% (130 of 145 thousand) were submitted as additional information on transactions through CBP’s Automated Commercial System (ACS).
About 12% came through FDA’s new Web-based Prior Notice System Interface (PNSI). 
A prior notice typically is the equivalent of an FDA line on an ACS entry.  
The number of submissions in this chart indicates the number of FDA lines received through ACS that have an FDA flag of FD 3  or FD 4, indicating their Harmonized Tariff Code (HTS) requires a prior notice.  
FD3 – may be subject to pn, depending on intended use
FD4 – subject to pn
A few of these may get disclaimed because they are not actually food products, such as a generic HTS code for “American Goods Returned”.  
On average, about 1% of the lines received from ACS have the FD3 or FD4 flag set on HTS codes that cover products that are not subject to prior notice.
Except for a small dip in late January, the number of submissions is slowly increasing.

## ACS Submission By Source

- Blue:  Products with “complete” data
- Yellow:  Products with incomplete data
- Green:  Products with no prior notice data

**Notes:**
The chart below summarizes FDA’s information on compliance for submissions through ACS.  
It indicates that slightly less than half of the total number of lines submitted for the weeks shown had complete prior notices.  
Slightly over half had some, but not all, of the prior notice information required.  
Only a very few lacked any of the specific prior notice information. 

## Percent of Information Complete

**Notes:**
The last three charts provide a detailed look at the percent of submissions that had information in specific data elements required for prior notice.  
Because PNSI validation will not allow submission without some required information, the percent complete is somewhat higher in several areas.  
FDA and CBP will be focusing educational efforts on these areas of concern.  
Although in some areas compliance appears to be high, completeness does not necessarily imply the information submitted is fully valid.  
Additional reports are being developed which will focus on the validity of the data being submitted 

## Percent Complete by Mode of Transportation (ACS)

**Notes:**
This comparison of submissions from PNSI and ACS helps to define where efforts to increase compliance need to be concentrated. 
In both cases compliance for imports via land (largely trucks) generally lags behind that for other modes of transportation.  
Some of the differences between the systems is attributable to the current differences in edit checks between PNSI and ACS.  
Most of these, like Registration Number, were left open during the period of enforcement discretion to allow time for submitters to change their procedures to begin capturing and entering the required data.  
Others, like the low compliance rate for land carriers in ACS may indicate an area where compliance is particularly challenging, and may require further outreach and cooperation between FDA and industry to obtain full compliance. 
Again, completeness does not mean the entry is valid.

## Percent Complete by Mode of Transportation (PNSI)

## For Further Information . . .

- <date/time>

**For Further Information . . .**

**For current information on FDA’s efforts under the Bioterrorism Act**
- 	_[http://www.fda.gov/oc/](http://www.fda.gov/oc/)__[bioterrorism/bioact.html](http://www.fda.gov/oc/bioterrorism/bioact.html)_

**Notes:**
Talkpoints: For current information on FDA’s efforts under the Bioterrorism Act or to obtain an electronic copy of these slides visit the web address listed on the screen.
p. 58981, column 2 

## Outreach

**Materials**
**Are **
**Available**
**On FDA’s **
**Website**

## Questions Regarding “Does The Rule 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://](http://www.cfsan.fda.gov/~dms/guidance.html)**__**[www.cfsan.fda.gov/~dms/guidance.html](http://www.cfsan.fda.gov/~dms/guidance.html)**_

## Questions Regarding Does A Rule 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:  **_**[furls@fda.gov](mailto:furls@fda.gov)**_
**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**

## Technical 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:  **_**[furls@fda.gov](mailto:furls@fda.gov)**_**  **
**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 **_**[Deborah.Ralston@fda.hhs.gov](mailto:Deborah.Ralston@fda.hhs.gov)**_** **

**Notes:**
If you need assistance in registering your facility, there is a registration tutorial you can access at www.fda.gov/furls, as well as a help button for assistance when you are in the process of completing the form online. 
There is also an Online Registration Help Desk you can call toll-free from within the U.S. at 1-800-216-7331. From outside the U.S., call 301-575-0156, which is not a toll-free call. 
Questions can also be faxed to 301-210-0247. This number is also not toll-free. 
These phone numbers are staffed on business days from 7 AM until 11 PM U.S. Eastern Time. Questions can also be emailed to furls@fda.gov 

## Slide 130