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| Background: |
The events of September 11, 2001 reinforced the need to enhance the security of the US food supply. The US congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 which was signed into law on June 12, 2002 by the President. |
| Objective |
To improve the ability of the United States to prevent, prepare for and respond to bioterrorism and other public health emergencies; and
National preparedness for bioterrorism and other public health emergencies. |
Highlights of the Interim Final Rule : More important for spice industry: (The interim final rule is available at http://www.cfsan.fda.gov/` |
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As per USFDA’s Interim Final Regulation issued to implement the provisions of the Bioterrorism Act, all domestic and foreign facilities that manufacture/process, pack or hold food for human or animal consumption in the USA has to register with FDA; Such a Regulation will help FDA to determine the location and source of any potential or actual bioterrorist incident or an outbreak of food-borne illness, and take corrective action. |
Spices, Spice Products and Spice Ingredients in any form imported into USA are covered by this Regulation. The purpose of this Registration is to assist FDA in responding to threatened or actual bioterrorist incident or other food Regulation emergencies in time. |
The owner, operator, or agent in charge of a domestic or foreign facility that manufactures/processes, packs, or holds food for human or animal consumption in the US or an individual authorized by one of them, must register that facility with FDA by December, 12, 2003. A domestic facility must register whether or not food from the facility enters interstate commerce. A foreign facility must designate a US agent [for example a facility’s importer or broker], who must live or maintain a place of business in the US and be physically present in the US for purposes of registration. |
If a foreign facility that manufactures/processes, packs, or holds food sends it to another foreign facility for further manufacturing/processing or packaging before the food is exported to the US, only the second foreign facility is required to register. However, if the second foreign facility performs only a de minimus activity, such as putting on a label, both facilities would be required to register. Also, any foreign facility that packs or holds food after the last foreign manufacturer/processor of the food must register. |
The following facilities are exempted from Registration: |
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| 1. |
Private residences of individuals, even though food may be manufactured/processed, packed, or held there. |
| 2. |
Non-bottled water drinking water collection and distribution establishments and structures, such as municipal water systems. |
| 3. |
Transport vehicles that hold food only in the usual course of their business as carriers. |
| 4. |
Farms i.e. facilities 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. The term “farm” also includes facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership, and facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership. A farm-operated roadside stand that sells food directly to consumers as its primary function would be exempt from registration as a retail food establishment. |
| 5. |
Restaurants, i.e. facilities that prepare and sell food directly to consumers for immediate consumption, including pet shelters, kennels, and veterinary facilities that provide food directly to animals. Facilities that provide food to interstate conveyances, such as commercial aircraft, or central kitchens that do not prepare and serve food directly to consumers are not restaurants for purposes of the rule. |
| 6. |
Retail food establishments, such as grocers, delis, and roadside stands, that sell food directly to consumers as their primary function, meaning that annual sales directly to consumers are of greater dollar value than annual sales to other buyers. An establishment that manufactures/processes, packs, or holds food and whose primary function is to sell food directly to consumers, including food that the establishment manufactures/processes, from that establishment is a retail food establishment and is not required to register. |
| 7. |
Nonprofit food establishments, which are charitable entities that meet the terms of 501[c][3] of the Internal Revenue Code and that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the US Central food banks, soup kitchens, and nonprofit food delivery services are examples of nonprofit food establishments. |
| 8. |
Fishing vessels that harvest and transport fish. Such vessels may engage in practices such as heading, eviscerating, or freezing fish solely to prepare the fish for holding on board the vessel and remain exempt. |
| 9. |
Facilities regulated exclusively and throughout the entire facility by the US Department of Agriculture, that is, facilities handling only meat, poultry or egg products. |
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| When to Register? |
Facilities covered under this rule must be registered by December 12, 2003. |
Registration is required only once for each hold food facility. However required registration information must be updated if it changes. |
Registration fee : There is no fee for registration or for updates of any registration. |
| How to Register: |
The Registrants must use Form 3537 to register or update a registration. Facilities can register online via the Internet. To register electronically, a registrant has to visit http://www.fda.gov/furls, which is available for registration 24 hours a day, 7 days a week There is also an Online Registration Help Desk: |
» In the US call 1-800-216-7331 or 301-575-0156
» From elsewhere call 301-575-0156
» Fax questions to 301-210-0247
» Email questions to furls@fda.gov |
A facility can also have the registration by mailing a request to:
Paper copy of the form may be obtained from :US Food & Drug Administration, HFS 681, 5600 Fishers Lane, Rockville MD 20857, USA. Filled in forms can be mailed to the above address or faxed to (301)210-0247. |
| Details to be Furnished: |
Each Registrant must include the name, address and phone number of the facility and its parent company [if applicable] the name, address, and phone number of the owner, operator, or agent in charge, all trade names the facility uses, applicable food categories as identified in FDA’s Regulation [21CFR 170-3], a statement certifying the information submitted is true and accurate and that the person submitting the registration, if not the owner, operator or agent in charge, is authorised to submit the registration. |
(For information on food product category, FDA lists the more common categories in the Product Code Builder at: www.fda.gov/search/databases.html.) |
A foreign facility must also provide the name, address, and phone numbers of its US agent. The foreign facility must also provide the emergency contact phone number of its US agent. A domestic facility must also provide an emergency contact phone number. |
When there is any change in the information given, an update should be submitted within 60 days of the change through the internet or paper. |
| Closure/Stopping of Business: |
When a facility goes out of business, its registration must be cancelled using Form 3537a. The former owner must cancel the registration [3537a] and the new owner must re-register the facility using Form 3537. |
| Penalty for Non-Compliance: |
Failure of a domestic or foreign facility to register, update required elements or cancel its registration in a prohibited act under the Federal Food Drug and Cosmetic Act attracting both civil and criminal action. |
When a food component is put on hold for want of registration, the carrier will be informed by FDA or CBP [Customs and Border Protection]. |
The food imported or offered for import from unregistered facilities must be held at the port until the facility is registered. |
| Role of the Agent: |
The Agent is required to reside or maintain a place of business in the USA and to be physically present in the US. The US Agent will not be responsible for violation of the Bio-Terrorism Act that are committed by the foreign facility. |
FDA however would consider legal action against a US Agent where the agent knowingly submitted false information to FDA or the Agent and the foreign facility were affecting the same agency. Liability issued between the facility and it’s Agent share to a pre contractual terms agreed upon. |
Role of the Agent in US is to act as a communication link between the facility and the FDA. The Agent has to be accessible to FDA throughout the 24 hours of the day [round the clock]. |
A foreign facility may have several importers, but only one agent to deal with FDA in the above matters [The word Agent used is Singular]. |
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The Bioterrorism Act requires that FDA receives prior notice of food imported into the US, beginning on December, 12, 2003. FDA will use this information in advance of the arrival, to review, evaluate and assess the information and determines whether to inspect the imported food. |
Prior notice must be received and confirmed electronically by FDA within the following time frame: |
| 1. |
Not less than 2 hours before arrival by land by road |
| 2. |
Not less than 4 hours before arrival by air or buy land by rail |
| 3. |
Not less that 8 hours before arrival by water |
| 4. |
The notice should not reach before 5 days before the arrival. |
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Prior notice must be received and confirmed electronically by FDA before food is mailed by international mail. |
For technical assistance in submitting prior notice, contact furls@fda.gov. |
| Who can send Prior Notice: |
| Any individual with knowledge of the required information may submit the prior notice including brokers, importers and US Agents. |
| Prior notice are necessary for import of all food items including raw agricultural products, compensating food and spices/spice products. |
| Confirmation: |
| When USFDA receives correct prior notice information a confirmation will be issued to the submitter. |
| Examples of food include: |
- 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
- 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 food animals
- Animal feeds and pet food |
| What foods are excluded from prior notice requirement? |
Food carried by or otherwise accompanying an individual arriving in the United States for that individual’s personal use) i.e., for consumption by themselves, family, or friends and not for sale or other distribution, food that is exported without leaving the pot of arrival until export, meat food products, poultry products and egg products that are subject to the exclusive jurisdiction of the US Department of Agriculture under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act and food that was made by an individual in his/her personal residence and sent by that individual as a personal gift(ie., for non business reasons) to an individual in the US. |
| Food Consignments that are Refused Entry: |
In such cases, the prior notice must also include the port of arrival, the location when the refused food is being held, the date of arrival at the location and the identification of the contact person at the location. |
| No Prior Notice: |
Food that is imported of offered for import with inadequate prior notice is subject to refusal and holding at the port or is secure stage. |
| Prior Notice Information: |
Prior notice can be submitted either through Automated Broker Interface of the Automated Commercial System(ABI/ACS) with effect from 12.12.2003. |
The notice should contain: |
1. |
Identification of the submitter, including name, telephone and fax numbers, email address, and firm name and address |
2. |
Identification of the transmitter [if different from the submitter], including name, telephone and fax numbers, email address, and firm name and address |
3. |
Entry type and CBP identifier |
4. |
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 applicable] |
5. |
The identification of the manufacturer |
6. |
The identification of the grower, if known |
7. |
The FDA Country of Production |
8. |
The identification of the shipper, except for food imported by international mail |
9. |
The country from which the article of food is shipped or, if the food is imported by international mail, the anticipated date of mailing and country from which the food is mailed |
10. |
The anticipated arrival information [location, date and time] or, if the food is imported by international mail, the US recipient [name and address] |
11. |
The identification of the importer, owner and ultimate consignee, except for food imported by international mail or transshipped through the United States |
12. |
The identification of the carrier and mode of transportation, except for food imported by international mail |
13. |
Planned shipment information, except for food imported by international mail. |
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In case of any changes in the above, a new prior notice must be submitted. |
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