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FDA Agents Inc.

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U.S. Agent and Registration of Food Facilities Worldwide
for the United States Food and Drug Administration

• Intervention de la FDA dans la Nouvelle Législation sur le Bioterrorisme
• Protection de la Chaîne Alimentaire (FDA Press Release of January, 2003)
• Enregistrement des Etablissements Alimentaires
• Definitions
• Commentaires Officiels concernants l'Agents U.S En Général

PROTECTION DE LA CHAÎNE ALIMENTAIRE:
Proposition de réglementation: Immatriculation des entreprises de produits alimentaires.

La loi relative à la prévention et à la gestion des risques sanitaires et du bioterrorisme(Public Health Security and Bioterrorism Preparedness and Response Act) de 2002 (ci-après, loi sur le bioterrorisme ou Loi) exige que les entreprises nationales et étrangères qui fabriquent, traitent, conditionnent ou conservent des produits alimentaires destinés à la consommation humaine ou animale aux Etats-Unis soient immatriculées auprès de la FDA avant le 12 décembre 2003. Première d'une série de mesures requises par la loi relative au bioterrorisme pour permettre à la FDA de répondre rapidement à une menace ou attaque terroriste réelle contre la chaîne alimentaire américaine, l'enregistrement l'aidera à détecter les localisation et cause de la menace potentielle et permettra à l'agence d'informer rapidement les installations susceptibles d'être concernées.

Selon la proposition, qui doit être enregistré ? Les propriétaires, opérateurs ou agents responsables d'installations nationales ou étrangères qui fabriquent, traitent, conditionnent ou conservent des produits alimentaires destinées à la consommation humaine ou animale aux Etats-Unis devront immatriculer leurs installations auprès de la FDA. Les entreprises nationales devront être immatriculées, que les produits alimentaires provenant de ces installations entrent ou non dans le commerce entre Etats. Les installations étrangères impliquées dans les activités énumérées ci-dessus devront également être immatriculées, excepté si les produits qui en proviennent passent par un traitement ou conditionnement ultérieur dans d'autres installations étrangères avant d'être exportés aux Etats-Unis. Néanmoins, si la seconde installation étrangère effectue des opérations minimales telles que l'apposition d'étiquettes, les deux installations devront être déclarées.

Quelles sont les installations exemptées de l'immatriculation ? Les fermes, établissements de vente d'aliments au détail, restaurants, établissements à but non lucratif préparant des produits alimentaires pour, ou les servant directement aux consommateurs, les bateaux de pêche non impliqués dans le traitement [tel que défini à 21 CFR 123.3 (k)], ainsi que les installations entièrement et exclusivement régulées par le ministère de l'Agriculture américain sont exemptés de cette immatriculation.

Que se passera-t-il si une installation n'est pas immatriculée au 12 décembre 2003 ? Selon la loi relative au bioterrorisme, l'absence d'immatriculation est un acte prohibé. Le gouvernement fédéral pourra se constituer partie civile devant les tribunaux fédéraux pour assigner les personnes ayant commis un acte interdit, ou bien engager une action pénale contre ceux qui ont commis cet acte prohibé. Si des installations étrangères non immatriculées tentent d'importer des produits alimentaires aux Etats-Unis, la loi relative au bioterrorisme exige que ceux-ci soient retenus au port d'entrée, excepté si la FDA déclare qu'ils doivent être transportés à un emplacement sécurisé. La FDA dispose que dans ce cas, les parties privées impliquées (c'est-à-dire le propriétaire, l'acheteur, l'importateur ou le récepteur des denrées) doivent prendre leurs dispositions pour le déplacement des produits et informer au plus ttt la FDA de leur localisation. Tous les frais inhérents au déplacement ou au stockage des produits seront à la charge des parties privées.

Quelles sont les méthodes d'immatriculation proposées ? L'enregistrement peut se faire par courrier électronique, via Internet, ou par écrit en courrier postal. L'agence encourage toutefois fortement la voie électronique, qui sera plus rapide et plus pratique. Le système que l'agence prévoit de mettre en place acceptera les immatriculations électroniques depuis n'importe quel point du globe 24 heures sur 24, 7 jours sur 7. L'installation demandant l'immatriculation recevra confirmation de son enregistrement électronique et son numéro d'immatriculation immédiatement après avoir rempli tous les champs requis sur l'écran d'enregistrement. L'immatriculation par courrier postal pourait prendre de plusieurs semaines à plusieurs mois, selon la rapidité du système postal et le nombre d'immatriculations que la FDA devra saisir manuellement.

Quand les installations peuvent-elles se faire immatriculer ? La mise en route des systèmes électronique et papier de la FDA est prévue au moins deux mois avant le 12 décembre 2003, date limite légale des immatriculations. La FDA publiera au Registre fédéral avant le 12 octobre 2003 la réglementation définitive sur l'enregistrement ou un avis avec l'adresse à laquelle les formulaires d'immatriculation écrits doivent être envoyés, si la réglementation définitive ou le système électronique ne sont pas été terminés à cette date. Les adresses auxquelles adresser les demandes de formulaires écrits d'immatriculation seront incluses.
[portions adapted for publication]

Les demandes d'immatriculation ne doivent pas être envoyées à la FDA avant le 12 octobre 2003. Les courriers reçus avant cette date ne seront pas acceptés.

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Intervention de la FDA dans la nouvelle législation sur le bioterrorisme

Le 12 juin, le Président George W. Bush a ratifié la loi sur la prévention et gestion des risques sanitaire et bioterroriste (Public Health Security and Bioterrorism Preparedness and Response Act) de 2002, composée de nombreuses dispositions destinées à garantir la sécurité des Etats-Unis face au bioterrorisme, dont de nouveaux pouvoirs pour le secrétariat d'Etat à la Santé et aux Services sociaux (HHS) afin qu'ils protègent la chaîne alimentaire nationale contre la menace de contamination intentionnelle. La Fédération américaine des aliments et produits medicamenteux (FDA), organisme réglementaire du HHS pour les produits alimentaires, est responsable de l'élaboration et de la mise en œuvre de ces mesures relatives à la sécurité alimentaire qui comprennent quatre réglementations majeures. Cette brochure est destinée à fournir une vue d'ensemble des dispositions de la loi relative la sécurité alimentaire.

Nouvelles réglementations: La FDA va proposer des réglementations sur les principales dispositions suivantes de la loi relative au bioterrorisme. A l'exception de certains cas particuliers, ces nouvelles réglementations s'appliqueront à toutes les installations de produits alimentaires et d'alimentation animale régulées par la FDA, y compris les compléments diététiques, l'alimentation infantile, les boissons (y compris boissons alcoolisées) et les additifs.

Immatriculation des installations de produits alimentaires - Les installations nationales ou étrangères qui fabriquent, traitent, conditionnent, distribuent, reçoivent ou conservent des produits alimentaires destinés à la consommation humaine ou animale aux Etats-Unis devront être déclarées auprès de la FDA au plus tard le 12 décembre 2003. Cette déclaration comprend la fourniture de renseignements à la FDA, tels le nom de la société, son adresse, etc. Les fermes, restaurants, établissements de vente de produits alimentaires au détail, établissements à but non lucratif de préparation ou de service de produits alimentaires et les bateaux de pêche non impliqués dans le traitement tel qu'il a été défini dans le 21 CFR 123.3 (k), ainsi que les installations exclusivement régulées par le ministère américain de l'Agriculture sont exemptées de cette obligation. En sont également exemptées les installations étrangères si les denrées qu'elles produisent doivent passer ensuite par un traitement ou un conditionnement dans une autre installation située en dehors des Etats-Unis. Néanmoins, si la seconde installation étrangère effectue des opérations minimales telles que l'apposition d'étiquettes, les deux installations devront être déclarées. Les réglementations de la FDA seront applicables au plus tard le 12 décembre 2003, mais conformément à la loi relative au bioterrorisme, les installations devront être immatriculées avant cette date même si les réglementations ne sont pas encore en vigueur.

Under the proposal all domestic food facilities would be required to register whether or not food from the facility enters interstate commerce. Except for specific exemptions, the new regulation would apply to all facilities for all foods and animal feed products regulated by FDA, including dietary supplements, infant formula, beverages (including alcoholic beverages), and food additives.

The proposed regulation would require the owner, operator, or agent in charge of a domestic or foreign facility to submit a registration to FDA, including the name and address of each facility at which, and trade names under which, the registrant conducts business, and the categories of food the facility handles. For a foreign facility, the registration must include the name of the U.S. agent for the facility. The U.S. agent may register a foreign facility if it is authorized to do so by the facility. The proposal also would require facilities to update any changes to the information previously submitted within 30 days of the change.

The proposal specifically excludes farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer, certain fishing vessels, and facilities (such as meat and poultry slaughterhouses) that are regulated exclusively by the U.S. Department of Agriculture. Also exempt are foreign facilities if the food from the facility undergoes further processing or packaging by another foreign facility before it is exported to the U.S. A foreign facility is not exempted from registration, however, if the processing or packaging activities of the subsequent facility are limited to the affixing of a label to a package or other de minimis activity. In that instance, both the facility manufacturing/processing the food and the facility performing the de minimis activity would have to register.

The law requires FDA to notify the registrant of receipt of registration and to assign each facility a unique registration number. The registration may be electronic, via the Internet, or by paper through surface mail. FDA strongly encourages electronic registration, however, as the Internet system FDA plans will be able to accept electronic registration from anywhere in the world 24 hours a day, 7 days a week. A registering facility also would receive confirmation of electronic registration and its registration number instantaneously once all the required fields on the registration screen are completed.

Under the Bioterrorism Act, facilities must register by December 12, 2003, even if FDA has not issued final regulations. In the proposed rule, FDA is offering the public 60 days to comment on the proposed rule. FDA plans to issue a final rule by October 12, 2003, after considering the comments it receives. FDA also plans to have its registration system operational by October 12, 2003, to accept early registrations.

Under the Bioterrorism Act, it is a prohibited act for a facility to not be registered by December 12, 2003. If a firm does not register by the deadline, the United States can bring a civil action in federal court to enjoin persons who commit a prohibited act; or it can bring a criminal action in federal court to prosecute persons who commit a prohibited act. The Bioterrorism Act also requires food from unregistered foreign facilities to be held at the port of entry unless the FDA directs that the food be moved to a secure location.
[portions adapted for publication]

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1. In General
   Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at the end the following:

Section 415. «NOTE: 21 USC 350d.» Registration of Food Facilities

1. Registration
1. «NOTE: Regulations»  In general
   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. To be registered
1. for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary; and
2. for a foreign facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility.
2. Registration.  An entity (referred to in this section as the `registrant') shall submit a registration under paragraph (1) to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business and, when determined necessary by the Secretary through guidance, the general food category (as identified under section 170.3 of title 21, Code of Federal Regulations) of any food manufactured, processed, packed, or held at such facility. «NOTE: Notification.»  The registrant shall notify the Secretary in a timely manner of changes to such information.
3. «NOTE: Notification»  Procedure
   Upon receipt of a completed registration described in paragraph (1), the Secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered facility.
4. «NOTE: Records»  List
   The Secretary shall compile and maintain an up-to-date list of facilities that are registered under this section. Such list and any registration documents submitted pursuant to this subsection shall not be subject to disclosure under section 552 of title 5, United States Code. Information derived from such list or registration documents shall not be subject to disclosure under section 552 of title 5, United States Code, to the extent that it discloses the identity or location of a specific registered person.
2. Facility. For purposes of this section:
1. The term "facility" includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations).
2. The term "domestic facility" means a facility located in any of the States or Territories.
3.  
1. The term "foreign facility" means a facility that manufacturers, processes, packs, or holds food, but only if food from such facility is exported to the United States without further processing or packaging outside the United States.
2. A food may not be considered to have undergone further processing or packaging for purposes of subparagraph (A) solely on the basis that labeling was added or that any similar activity of a de minimis nature was carried out with respect to the food."
3. Rule of Construction. Nothing in this section shall be construed to authorize the Secretary to require an application, review, or licensing process.

Section 415. «NOTE: 21 USC 350d.» Registration of Food Facilities

2. Prohibited Acts. Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 304(d) of this Act, is amended by adding at the end the following:
• (dd) The failure to register in accordance with section 415.

Section 801 of the Federal Food, Drug, and Cosmetic Act

3. Importation; Failure to Register
   Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 304(e) of this Act, «NOTE: 21 USC 381.»  is amended by adding at the end the following subsection:
1. (1) If an article of food is being imported or offered for import into the United States, and such article is from a foreign facility for which a registration has not been submitted to the Secretary under section 415, such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until the foreign facility is so registered. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.
4. «NOTE: 21 USC 350d note.»  Electronic Filing. For the purpose of reducing paperwork and reporting burdens, the Secretary of Health and Human Services may provide for, and encourage the use of, electronic methods of submitting to the Secretary registrations required pursuant to this section. In providing for the electronic submission of such registrations, the Secretary shall ensure adequate authentication protocols are used to enable identification of the registrant and validation of the data as appropriate.

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Section 1.227  What definitions apply to this subpart?

1. The act means the Federal Food, Drug, and Cosmetic Act.
2. The definitions of terms in section 201 of the act (21 U.S.C. 321) apply to such terms when used in this subpart.
3. In addition, for the purposes of this subpart:
1. Calendar day means every day shown on the calendar.
2. Facility means any establishment, structure or structures 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 consumption in the United States. Individual homes are not facilities if the food that is manufactured / processed, packed, or held in the home does not enter commerce. A facility may consist of one or more contiguous structures. A single building may house distinct facilities if they are under separate management.
1. Domestic facility means any facility located in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
2. Foreign facility means a facility other than a domestic facility that manufactures/processes, packs, or holds food for consumption in the United States.
3. Farm means a facility in one general physical location devoted to the growing of crops for food, the raising of animals for food (including seafood), or both. The term "farm'' includes:
1. Facilities that pack or hold food, provided that all food used in such activities is grown or raised on that farm or is consumed on that farm; and
2. 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.
4. Food has the meaning given in section 201(f) of the act. Examples of food include, but are not limited to, fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or components of food, animal feed, including pet food, food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food, dietary supplements and dietary ingredients; infant formula, beverages, including alcoholic beverages and bottled water, live food animals, bakery goods, snack foods, candy, and canned foods.
5. Holding means storage of food. Holding facilities include, but are not limited to, warehouses, cold storage facilities, storage silos, grain elevators, or liquid storage tanks.
6. Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples include, but are not limited to: Cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging.
7. Nonprofit food facility means a charitable entity that prepares, serves, or otherwise provides food to the public. The term includes, but is not limited to, food banks, soup kitchens, and nonprofit food delivery services. To qualify as a nonprofit food facility, the entity must be exempt from paying federal income tax under the U.S. Internal Revenue Code.
8. Packing means placing, putting, or repacking food into different containers without making any change to the form of the food.
9. Port of entry means the water, air, or land port at which the article of food is imported or offered for import into the United States, i.e., the port where food first arrives in the United States. This port may be different than the port where the article of food is entered for U.S. Customs Service purposes.
10. Restaurant means a facility that prepares and sells food directly to consumers for immediate consumption. Restaurants include, but are not limited to, cafeterias, lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens. Facilities that provide food to interstate conveyances, rather than directly to consumers, are not restaurants.
11. Retail facility means a facility that sells food products directly to consumers only. The term includes, but is not limited to, grocery and convenience stores, vending machine locations, and commissaries. The term includes facilities that not only sell food directly to consumers, but that also manufacture/process food in that facility solely for direct sale to consumers from that same facility.
12. U.S. agent means a person residing or maintaining a place of business in the United States whom a foreign facility designates as its agent. A U.S. agent cannot be in the form of a mailbox, answering machine, or service, or other place where an individual acting as the foreign facility's agent is not physically present. The U.S. agent acts as a communications link between FDA and the facility. FDA will treat representations provided by the U.S. agent as those of the foreign facility, and consider information provided to the U.S. agent as the equivalent of providing the same information or documents to the foreign food facility.
13. You or registrant means the owner, operator, or agent in charge of a facility that manufactures/processes, packs, or holds food for consumption in the United States.

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[portions adapted for publication from a similar agent program]
As stated earlier, section 510(i) of the act requires foreign establishments to identify a United States agent. The preamble to the proposed rule explained that FDA interpreted this provision as requiring the agent to be an individual, firm, or company physically located in the United States (see 64 FR 26330 at 26331). The preamble to the proposed rule added that the United States agent could not be a mailbox, answering machine or answering service, or any other place where an individual acting as the foreign establishment's agent is not physically present.

As for advising foreign establishments to select their United States agents carefully, FDA was emphasizing that its interactions with a United States agent could involve proprietary information, particularly in emergency situations (see 64 FR 26330 at 26334). FDA must be able to communicate freely with a United States agent in these situations; otherwise, if the United States agent is unable or unauthorized to speak to FDA, the United States agent has little or no value in serving as a contact between FDA and the foreign establishment. FDA takes no position whether a foreign establishment should select a U. S. distributor to be its United States agent.

The United States agent would be responsible for assisting FDA in communications with the foreign establishment, responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assisting FDA in scheduling inspections of the foreign establishment. The proposal also authorized FDA to provide information or documents to the United States agent if FDA is unable to contact the foreign establishment directly or expeditiously

Several comments asked about the United States agent's liability...expressed concern about the United States agent's exposure to litigation from parties in the United States who sue the foreign establishment....they had surveyed various U. S. firms or contacted U. S. attorneys and found that none were willing to act as a United States agent; U. S. firms were concerned about their potential legal liability.

If a foreign establishment violates the act, FDA would pursue action against that foreign establishment. Examples of instances where FDA might take action against the United States agent would be where the agent submitted false information to FDA or the agent and the foreign establishment were effectively the same entity.

As for the United States agent's liability in third party litigation (i.e., situations where a private party sues the foreign establishment and attempts to attach or enforce a judgment by attaching the United States agent's assets), such issues are beyond the scope of this rule. FDA does not have authority to insulate United States agents from such litigation, and such litigation would be a matter of State, rather than Federal, law.

One comment would permit a United States agent to notify FDA about changes to its name or address or even whether a person no longer serves as a foreign establishment's United States agent.

FDA agrees and has revised Secs. 207.40(c)(3), 607.40(d)(3), and 807.40(b)(3) so that United States agents may report changes themselves

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