The events of September 11, 2001 highlighted the need to enhance the security of the U.S. food supply. One Hundred Seventh Congress of the United States of America responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act 2002 (Bioterrorism Act), which President George W. Bush signed into law (Public law 107-188) on June 12, 2002. The complete text of Bioterrorism Act is available here.
The Bioterrorism Act is divided into five titles. Provisions of Title III (Protecting Safety and Security of Food and Drug Supply), Subtitle A, Section 305 requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. The short Fact Sheet of this new regulation in English, Spanish and French is available here.
In compliance with Bioterrorism Act the Department of Health and Human Services of FDA has issued on October 10, 2003 two final Federal Register Notices:
Multilingual review of FDA actions on new Bioterrorism Legislation is available here.
It is important to understand clearly the term "facility" as it is defined by FDA. As per §1.227(c)(2) of Proposed Rule (21 CFR part 1 RIN 0910-AC40, page 5381) the facility defined as any establishment, structure or structures under one management at one general physical location, or, in case of mobile facility, traveling to multiple locations, that manufactures/processes, packs or holds food for consumption in the United States. FDA is clarifying that a facility is not limited to one building, but can consist of several contiguous structures. The definition "facility" also specifies that a facility must be under one management. This means, that for purposes of the proposed rule a single building may house distinct facilities if they are under separate management as well one company can manage several facilities if they are located at different general physical locations. If a facility is under joint management of two or more companies, the joint management arrangement is considered as one management.
As per above regulations the foreign food facilities must hire and retain the U.S. agents. The appointed US agent is acting for and on behalf of the foreign facility with power of attorney and treated by FDA as official facility's representative. The U.S. agent's responsibility include acting as communication link between FDA and foreign facility, such as FDA will treat representations provided by the U.S. agent to FDA as those of the foreign facility and will consider information FDA provides to the U.S. agent as the equivalent of providing the same information or documents directly to the foreign facility.
FDA assigning unique registration number to each facility registered. But please note, that assignment by FDA of a registration number to the facility not in any way means FDA’s approval or endorsement of facility or its products. Therefore any representation of food labeling that creates impression of official approval, endorsement or apparent safety because a facility is registered by FDA would be misleading and would misbrand the food.
Failure of either domestic or foreign facility to register is considered as prohibited act under section 301 of the act (21 U.S.C. 331). Under section 302 of the act (21 U.S.C. 332) the United States can bring a civil action in Federal court to enjoin persons who commit a prohibited act and, under section 303 of the act (21 U.S.C. 333), can bring a criminal action in Federal court to prosecute persons who commit a prohibited act. Under section 305a of the Bioterrorism Act, FDA can seek debarment of any person who has been convicted of a felony relating to importation of food into the United States (§ 1.241 of 21 CFR part 1 RIN 0910-AC40, page 5386).
FDA is not charging any fee for registration under Bioterrorism Act. However, the U.S. agent's services are provided for fees. FDA estimated U.S. agent's annual fee as $1,000-1,500 (Proposed Rule 21 CFR part 1 RIN 0910-AC40, vi, vii page 5396).
FDA is not charging any fee for submit of Prior Notice, which as per final Federal Register Notice 21 CFR part 1 RIN 0910-AC41 can be submitted by U.S. importer or purchaser or any person with knowledge of the required information on their behalf (Section 1278, page 58977). However, broker's fee for submitting of Prior Notice is estimated by FDA as $50-100 per entry (Table 3, page 59027).
FDA issued the following guidance documents for industry in light of the current situation we are facing in our nation:
as well FDA issued Final Two Proposed Food Safety Regulations:
We recommend you to watch the online video of FDA Actions on new Bioterrorism Legislation (available here in English, French and Spanish). Short review of FDA proposed regulations for registering food facilities is available here .
As per our opinion clear short synopsis and interpretation of the new rules in the U.S. food imports are published by the Irish Food Board.
We, as licensed U.S. importers, wholesalers and agents, working with FDA on daily basis, are providing to our foreign vendors as well as to any qualified third party the services of agency representation with FDA under Bioterrorism Act and 21 CFR part 1 RIN 0910-AC40.
We offer three Service Plans:
NOTE: Our service is not including submit of Prior Notice as per 21 CFR part 1 RIN 0910-AC41. Sending of Prior Notice is a job of every U.S. Purchaser or U.S. Importer or its agent/customs broker. We are not charging any fee from our vendors for submit of Prior Notice. The FINAL form of Prior Notice FDA Form 3540 in edition of October 9, 2003 is available for your information here .
If you would like to use our agency services:
STEP 1. Download our standard editable FDA Agency Agreement Form SECC A-11 and study it carefully. In case you accept it go to FDA web site and register your Facility by filling online DHHS/FDA Form 3537*. The registration page of FDA Industry Systems is located at https://www.access.fda.gov/oaa/ (copy and paste this URL into your browser). Please note that first you shall open account with FDA. Upon its opening you will receive e-mail from FDA with your Account ID and temporary Password. You shall change your Password at the first login to your FDA account**. After that you can register any number of your Facilities***. At the registration please do not forget to fill your emergency contact data into the Section 5. Best it should be owner or authorized officer of your company, maintaining 24/7 mobile phone. You shall include our data as U.S. Agent into the Section 7 as per sample 1 if you order Basic or Advanced Plan or as per sample 2 if you order Unlimited Plan . Upon completing of your Facility registration FDA will instantly send us e-mail with Initial Agent Assignment Notification with request to confirm or deny our agency commitment to your Facility.
STEP 2. Complete, duly sign FDA Agency Agreement and send it by fax +1-305-723-7792 to us. In case we receive in order we will countersign and fax/e-mail it to you back together with our Service Invoice.
STEP 3. Go to Trade Departments -> Enrolling -> Food Facilities of this web site and pay our Agency Fee. We accept American Express, MasterCard, EuroCard, Visa, Diners Club, Discover, PayPal, Electronic Checks, paper checks and bank/wire transfers.
STEP 4. Upon payment clearance we confirm FDA our agency commitment to your Facility.
*Under U.S. federal law (18 U.S.C. 1001), anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties. At the Section 13 of registration DHHS/FDA Form 3537 the submitter certifies under penalty that the submitted information is true and correct. As per our opinion any agent, for making responsible registration of Facility with FDA, shall study full package of registrant's documents (such as incorporation documents, business license, manufacturer's permit etc), confirming that the information which an agent is going to provide to FDA at registration is true and correct. We do not believe that any reasonable U.S. agent is making registration of Facilities with FDA without careful study of the above documents in original or notarized copy. At least we are not doing that. As well we do not believe that it is reasonable for any registrant to prepare and mail the notarized copies of Facility's documents to the U.S. agent instead of self using of FDA system of Facility registration by filling online DHHS/FDA Form 3537, which is accessible worldwide, FREE, simple and instant for any registrant from any country. If you have questions or need some clarifications - detailed instruction for filling of DHHS/FDA Form 3537 is available here.
**Your Password is confidential and you should not disclose it to any third party.
***You should not enter non-US-ASCII characters such as é, ß, ö. Non-US characters are not currently supported by FDA online registration system. Please use alternatives like e, ss, oe.
WARNING NOTICE FOR OUR VENDORS AND POTENTIAL VENDORS: On June 30, 2003 FDA issued Notice Regarding Firms Offering Registration Services, which we recommend you to read.
We would like to point your attention that several offers for FDA registration and agency services at the market are originating from either foreign companies, or companies maintaining only U.S. P.O. Box address, or companies declaring themselves as U.S. corporations or LLC, but per fact not incorporated, i.e. not existing in the U.S.A.
We ask our vendors who are not using our agency services to be extremely careful and to check if the a.m. services are provided by the agents, which are:
Offers/registrations, matching with one or more of the above criteria by our opinion could be fraudulent. In case of any doubt we recommend you to ask the agents for copy of Certificate of Good Standing or copy of Articles of Incorporation.
Hiring not existing U.S. agent makes registration not legitimate and can cause not only financial loss but also serious problems with U.S. law. As importers we carefully checking our vendors' and potential vendors' FDA registrations and just found several potentially fraudulent registrations/agents, which are now under investigation of corresponding U.S. federal authorities. To protect our business interest we will not accept any food shipment from foreign vendors, which registration with FDA is matching with any of the above warning criteria.
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