# Presentation: 889051

## Overview of Registration and 
Prior Notice Proposed Regulations Implementing the Bioterrorism Act

Leslye M. Fraser, Esq.
Associate Director for Regulations
Center for Food Safety and Applied Nutrition

**Prior Notice Proposed Regulations Implementing the Bioterrorism Act**
**Leslye M. Fraser, Esq.**
**Associate Director for Regulations**
**Center for Food Safety and Applied Nutrition**

## Purpose of Briefing

**Provide an overview of proposed regulations implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“the Bioterrorism Act”) (PL 107-188):**
**Section 305:  Registration of Food Facilities**
**Section 307:  Prior Notice of Imported Food Shipments**

## FDA Regulatory Development:Lead Personnel

| Senior Manager | L. Robert Lake | (301) 436-2379 |
| --- | --- | --- |
| Overall Lead | Leslye M. Fraser | (301) 436-2378 |
| Registration Lead | Leslye M. Fraser | (301) 436-2378 |
| Prior Notice Lead | Mary Ayling | (301) 436-2428 |

- E-mail:
- _[Lake.Lloyd@cfsan.fda.gov](mailto:Lake.Lloyd@cfsan.fda.gov)_
- _[Fraser.Leslye@cfsan.fda.gov](mailto:Fraser.Leslye@cfsan.fda.gov)_
- _[Ayling.Mary@cfsan.fda.gov](mailto:Ayling.Mary@cfsan.fda.gov)__ _

## Background:  FDA’s Regulatory Development Timeline

**July – Aug. 2002:  ****FDA held six outreach meetings to 36 Embassies and 52 organizations**
**Until Aug. 30, 2002****:  FDA received > 150 comments from stakeholders that we considered as we developed the proposed rules**

## Background:  FDA’s Regulatory Development Timeline

**Feb. 3, 2003:  ****FDA published proposed rules with 60 day comment period (ends April 4, 2003)**
***No extensions will be granted given statutory deadline***
**Jan. 29, 2003:  ****Public meeting via satellite downlink to domestic and international sites**
***Transcripts available in English, French & Spanish***
**By Oct. 12, 2003****:  FDA plans to issue final rules and have IT systems operational at this time (rules would be effective Dec. 12, 2003)**

## Regulatory Development Timeline (cont.)

**FDA also is developing two additional rules:**
**Section 306****:  Establishment and Maintenance of Records**
**Section 303****:  Administrative Detention**
**Goal:  by Mar. 31, 2003****, publish proposed rules and hold satellite downlink meeting shortly after**

## Proposed Registration Requirements68 FR 5378 (Feb. 3, 2003)

***Statutory Deadline:  December 12, 2003***
***(Self-executing if FDA misses deadline)***

## 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 would be required to register whether or not food from the facility enters interstate commerce**

**Notes:**
Question 2.

## Who Must Register?(cont.)

**Foreign facilities may choose to designate their ****U.S. agent as their agent-in-charge**** for purposes of registration**
**U.S. agent must *****reside or maintain a place of business *****in the United States**
**Proposed requirements consistent with FDA’s drug, biologics, and device registration regulations found in 21 CFR parts 207, 607, and 807, respectively**

## 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.”  ***
**Examples of FDA-regulated food:**
**Food and food additives for man or animals**
**Dietary supplements and dietary ingredients**
**Infant formula**

## Examples of FDA-Regulated Food(cont.)

**Beverages (including alcoholic beverages and bottled water)**
**Fruits and vegetables**
**Fish and seafood**
**Dairy products and shell eggs**
**Raw agricultural commodities for use as food or components of food**
**Canned foods**
**Live food animals**
**Bakery goods, snack food, and candy**

## Proposed Definitions

**Facility**** – an establishment or structure(s) *****under one management***** 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**
**A building that has multiple companies at the same address would be considered **_**>**_** 2 facilities**

## Proposed 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**

## Proposed Definitions (cont.)

**Packing**** – placing, putting, or repacking food into different containers without making any change to the form of the food**
**Holding ****– storage of food **
**e.g., warehouses, cold storage facilities, storage silos, grain elevators, liquid storage tanks**

## What Facilities Does The Proposed Rule Exempt?

**Non-profit facilities **
**Retailers**
**Farms**
**Restaurants**
**Fishing vessels, except those that engage in processing as defined in FDA’s seafood HACCP regulations (21 CFR 123.3(k))**
**Facilities subject to the *****exclusive ***** jurisdiction of the U.S. Department of Agriculture**

## What Facilities Does FDA Not Regulate?

**Facilities that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA)**
**NOTE:  USDA regulates meat products, poultry products, and egg products**

## Proposed Definitions (cont.)

**Non-profit facility**
**A charitable entity that prepares, serves, or otherwise provides food to the public **
**e.g.,  food banks, soup kitchens, and nonprofit food delivery services**
**Must be exempt from paying income tax under the U.S. Internal Revenue Code**

## Proposed Definitions (cont.)

**Retail facility****:**
**A facility that sells food products ****directly to consumers *****only*****; and**** **
**A facility that manufactures/processes food in that facility for direct sale to consumers from that same facility**

## Proposed Definitions (cont.)

**Restaurant**** – a facility that prepares and sells food *****directly to consumers *****for immediate consumption**
**e.g., cafeterias, 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**

## Proposed Definitions (cont.)

**Farm****:  a facility in one general physical location devoted to the growing of crops for food and/or the raising of animals for food (including seafood)**
**e.g., apple orchards, dairy farms, feedlots, and aquaculture facilities**

## Proposed 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****; and**
**Manufactures/processes**** food, if all of the food used in such activities is ****consumed on that farm**** or another farm under the same ownership**

## Additional Exemption for Some Foreign Facilities

**Foreign facilities**** that manufacture/process, pack or hold food also exempt IF . . .**
**	****. . . a subsequent **_**foreign**_** facility further manufactures/processes (including packaging) the food outside the U.S.**

## 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:**
Question 9

## “Mixed-Type” Facilities

**Some facilities may be “mixed-type” - ****i.e., some activities exempt; others subject to proposed registration requirements**
**E.g., grocery warehouse that sells food directly to both consumers and retailers**
**Facility would have to register because sales to retailers are not exempt**

## “Mixed-Type” Facilities(cont.)

**Some farms also may be mixed-type” facilities; ****e.g.,  farm has a juice processing facility on-site and/or a road-side stand that sells food grown on farm directly to consumers**
**Traditional farming activity****, such as growing oranges:  ****Exempt as farm**

**Notes:**
Question 11

## “Mixed-Type” Farm(cont.)

**Manufacturing/processing**** (e.g., oranges into juice):**
**If juice is consumed on farm: ****Exempt as a farm**
**If juice is distributed into commerce (e.g., sold to a distributor or retailer): ****Register juice processing facility**
**If juice is sold directly to consumers ****at farm’s road-side stand****:  Exempt ****as retailer**

## Proposal:  What InformationIs Required? 

**Name, full address, phone number, fax number, and e-mail address of the facility**
**Same information for the parent company, if the facility is a subsidiary**
**All trade names the facility uses**

**Notes:**
Question 12 (first slide).

## What Information Is Required? (cont.)

**Emergency contact person’s information (name, title, office and home phones, cell phone if available, and e-mail address, if available)**
**Food product categories (21 CFR 170.3)**
**FDA will issue guidance soon containing Secretary’s determination that food product categories are necessary for registration**

**Notes:**
Question 12 (second slide).

## What Information Is Required?(cont.)

**A statement that the information submitted is true and accurate and person is authorized to register the facility**
**The name and contact information of the person submitting the statement**
**Name of foreign facility’s U.S. agent and the agent’s contact information**

**Notes:**
Question 12 (third slide).

## Optional Information*(* Mandatory registration fields still required)

**Preferred mailing address**
**Type of activity (e.g., manufacturer/processor)**
**Additional food product categories**
**E.g., dietary supplements, infant formula, animal feed**
**Type of storage **
**“****Most/all” food product category (instead of mandatory food product categories)**
**Approximate dates of operation, if seasonal**

## Proposed Rule:  How to Register

**FDA **_**strongly encourages**_** electronic registration**
**Will be available 24/7 worldwide**
**Will not allow registration to be submitted until all mandatory fields completed**
**Will provide automatic receipt of registration and facility’s registration number**
**Internet access publicly available (e.g., libraries, copy centers)**
**Reminder:  U.S. agent can register foreign facility if authorized by facility**

## Proposed Rule:  How to Register(cont.)

**Paper registrations accepted if Internet access not reasonably available**
**Much slower process (weeks to months)**
**Need to ensure form is legible and complete, else 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**

## What if Changes Occur?

**Registration is one-time, not annual**
**No registration fee**
**But  updates required within 30 days of change of any information previously submitted to FDA (mandatory or optional fields)**

## What If A Facility Is Not Registered?

**Failure to register is a prohibited act**** **
**Imported food from an unregistered foreign facility shall be held at the port of entry until facility is registered, unless FDA directs its removal to a secure facility**
**Owner, purchaser, importer, or consignee must arrange for storage of the article of food in an FDA- designated secure facility**

## Next Steps

**These are *****proposed***** ****rules**
**No duty to comply now**
**Comments due *****no later than April 4, 2003***
**FDA plans to publish by Oct. 12, 2003****:**
**Final rule and have registration system operational; or**
**Notice stating where to mail registration**
**Registrations mailed before Oct. 12****th**** **_**will not be accepted**_

## Proposed Requirements for Prior Notice Regulation 68 FR 5428 (Feb. 3, 2003)

***Statutory Deadline:  December 12, 2003***
***Self-executing if FDA misses deadline****
**(***********Notice required of not less than 8 hours or more    than 5 days until final regulations in effect)**

## Sec. 307:  Prior Notice of Imported Food Shipments

**Per the Act, the prior notice must include the identity of:**
**the article**
**manufacturer and shipper**
**grower (if known)**
**originating country**
**country from which it was shipped**
**anticipated port of arrival**
**All statutory information, except grower, currently provided to Customs at time of entry**

## Prior Notice Implementation

**Customs cannot modify their systems by our deadline given other commitments **
**Phase 1:  Develop FDA IT system ****to receive prior notifications and inform Customs of status (e.g., prior notice received) **
**Phase 2****:  Prior notifications received into ****Customs Automated Commercial Environment**** (ACE)  (Est. FY 2005)**

## FDA’S Prior Notice:Proposed Definitions

**Country of shipment ****- the country in which the food was loaded onto the conveyance that brings it to the U.S.**
**Port of Entry**** – 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 food first arrives in the U.S.)**
**Note:  May be different than port where food is entered for U.S. Customs’ purposes**

## Port of Entry andCrossing Location

**Crossing Location = Port of Entry for Prior Notice**

**Port of Entry for U.S. Customs**

**Notes:**
Question 20.

## FDA’S Prior Notice: Proposed Definitions (cont.)

**Originating Country**** - the country from which the article of food originates:**
**Fresh produce or fresh aquacultured fish/seafood**** - country in which it is grown and harvested**
**Wild-caught fish or seafood**** harvested in U.S. waters or by a U.S. flagged vessel or processed aboard a U.S. flagged vessel - the U.S.  **
**All other food**** - country in which the article of food is manufactured/processed**

## Originating Country vs.Country of Origin

**RAW CARROTS**
**U.S.A. (****U.S. Customs Country of Origin****)**
**WASHED, PEELED, PACKAGED CARROTS**
**	****Foreign Country **** **
**	****(ORIGINATING COUNTRY)**

**CARROTS**
**WASHED**
**PEELED**

**Notes:**
Question 20.

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

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

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

## Proposal - Who is Authorized to Provide Prior Notice?

**The ****purchaser or importer**** of an article of food (or their agent) who resides or maintains a place of business in the U.S.**
**The ****arriving carrier or in-bond carrier****, if the article of food is imported for in-bond movement through the U.S. for export**
**E.g., Transportation for Exportation or Immediate Export entries**

## What Food is Subject to the Proposed Requirements?

**The definition in sec. 201 (f) of the Federal Food,  Drug and Cosmetic Act applies **
**See previous examples given on slides 10-11**
**Proposed definition the same as for Registration**

## What Food is Not Subject to  Proposed Prior Notice Requirements?

**Food in individual’s personal baggage for personal consumption (themselves, family, friends)**
**Meat, poultry and egg products that at the time of importation are subject to USDA’s *****exclusive***** jurisdiction**

## Proposal:  When Is My Prior Notice Due?

**By noon of the calendar day before**** the article of food arrives at the port of entry **
***Time is based on time zone at port of entry***
**Notice *****cannot***** be given more than 5 days before arrival**
**Up to 2 hours before arrival****:**
**Amendments to provide more specifics about product identity**
**Updates to anticipated arrival information**

## How do I Submit Prior Notice, Amendments & Updates?

**Must be submitted electronically through FDA’s Prior Notice System (Internet-based)**
**Will receive automatic confirmation of receipt with date and time**
**Available 24 hours/day, 7 days/week**

## Submitting Prior Notice, Amendments & Updates (cont.)

**If FDA’s system is down, can submit notice in person, e-mail or by fax to FDA District Office with responsibility for the geographical area in which the port of entry is located**
**Addresses/fax numbers of District Offices will be published at time of final rule**

## Proposal:  What Information is Required in a Prior Notice?

**Submitter **
**Firm **
**Individual**
**Entry type**
**Consumption, export**
**Customs code**
**Location if food is being held ****due to failure to submit prior notice (or adequate prior notice)**

**Notes:**
Question 8.

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

**Entry number and line numbers**
**Identity of the article of food**
**FDA product code - 7 digits**
**Common/usual/market name**
**Trade/brand name**
**Quantity**
**Identifiers, if applicable – (e.g., lot or code number)**

**Notes:**
Question 8.

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

**Manufacturer and shipper*******
**All ****importer(s), owner(s), consignees*******
*** Must include registration number of facility associated with the food if applicable**
**Grower****, if known**
**Originating country**
**Country**** from which the article was ****shipped**

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

**Anticipated arrival information**
**Port of entry**
**Date**
**Time**
**Customs port of entry**
**Carrier**** (including Standard Abbreviation Carrier Code)**

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

**Submission Type**
**Initial**
**Amendment to product identity**
**Update to anticipated arrival **
**Cancellation**

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

**Amendments – relates to *****identity***** of the product**
**To allow submitter to provide specifics that did not exist by deadline for initial submission**
**May be amended *****once *****if information did not exist at time of initial submission**
**Initial prior notice submission must indicate will amend**
**Cannot amend the *****nature***** of the food (e.g., can’t change fish to shrimp)**
**Due **_**>**_** ****2 hours before arrival ****at port of entry**

## What if the Information Changes After I Submit a Prior Notice (cont.)?

**Updates ****– required if anticipated arrival is:**
**1 hour or more *****earlier *****than submitted; or**
**3 hours or more *****later *****than originally submitted**
**Due **_**>**_** ****2 hours before arrival ****at port of entry**
**All other changes – cancel initial prior notice and submit a new prior notice**

## Sec. 307: Prior Notice of Imported Food Shipments

**Prohibited act to fail to provide notice**
**If no notice/adequate notice not provided, article refused admission**
**Article held at the port of entry or in secure storage until proper notice is provided**
**Transportation and storage costs borne by the owner, purchaser, importer or consignee**

## Next Steps

**These are *****proposed***** ****rules**
**No duty to comply now**
**Comments due *****no later than April 4, 2003***
**FDA plans to publish the final rule by ****Oct. 12, 2003 ****and have the prior notice system operational at this time for “test” prior notices**

## How Do I Get a Copy of the Proposed Rule(s)?

**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**

## How To Comment(Deadline April 4, 2003)

**Submit written comments to:**
**	**** ****Dockets Management Branch (HFA-305) **
**	**** ****Food and Drug Administration**
**5630 Fishers Lane, rm. 1061**
**Rockville, MD USA 20852**
**Submit electronic comments to:  **** **_**[http://www.fda.gov/dockets/ecomments](http://www.fda.gov/dockets/ecomments)**_
**YOU MUST INCLUDE THE DOCKET NUMBER:**
**02N-0276:  Registration; 02N-0278:  Prior Notice **

## For Further Information . . .

**For current information on FDA’s efforts under the Bioterrorism Act or to obtain an electronic copy of these slides: **
- 	_[http://](http://www.fda.gov/oc/)__[www.fda.gov/oc/](http://www.fda.gov/oc/)__[bioterrorism/bioact.html](http://www.fda.gov/oc/bioterrorism/bioact.html)_