United States: New FDA Rule Places Increased Food Safety Responsibility On Importers, Foreign Suppliers

On Nov. 27, 2015, the FDA published its Final Rule outlining how the food industry, already in the midst of implementing Hazard Analysis and Risk Based Preventive Controls, or HARPC (see our previous three-part series on HARPC here: 1, 2, 3), will be responsible for ensuring that foreign suppliers of food and food ingredients are implementing HARPC food safety plans and FDA current Good Manufacturing Practices (or cGMPs).

This new Rule entitled, "Foreign Supplier Verification Programs for Importers of Food for Humans and Animals" (or FSVP), is the most recent Rule promulgated under the Food Safety and Modernization Act, or FSMA, and places new responsibility on industry members to ensure that foreign suppliers follow the FDA's HARPC requirements, that compliance is documented, and that importers include this new supply chain verification system in their HARPC food safety plans.


The FSVP applies to anyone who is considered an "Importer" under the new Rule. An Importer is defined as "the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative" of the foreign food supplier at the time of entry into the U.S. While this definition means that the FSVP rule applies to the vast majority of companies accepting food or food ingredient products into the U.S., there are some exceptions, wherein the FSVP Rule either does not apply or, in some cases, modified or reduced FSVP rules apply:

FSVP does not apply to:

  • Fish and other seafood produced under a HACCP plan;
  • Juice and juice products produced under a HACCP plan;
  • Food for research and evaluation;
  • Certain alcoholic beverages and their ingredients;
  • Meat, poultry and egg products regulated by the USDA;
  • Food imported for personal consumption;
  • Food that is transshipped;
  • Food that is imported for processing and subsequent export;
  • U.S. food that is exported and re-imported without further processing in a foreign country; and
  • Manufacturers, processors and holders exempt from HARPC regulation.

Modified or reduced FSVP requirements apply to:

  • Dietary supplements subject to cGMPs under 21 C.F.R. § 111;
  • Very small importers;
  • Importers that import from certain very small suppliers; and
  • Importers that import from countries that have food safety regulatory controls that have been recognized by the FDA or found to be equivalent to those required by FSVP and HARPC.

Application of FSVP regulations

The new FSVP Rule consists of the following seven steps for which the Importer is responsible for completing and documenting when importing any food or food ingredient:

  1. Identify the hazards with each food or food ingredient that are reasonably likely to cause illness or injury. This identification process should be uniform and consistent across all food or food ingredient products.
  2. Evaluate the risk of the hazard as identified and posed by each imported food and evaluate the foreign supplier's performance in mitigating these risks.
  3. Conduct supplier verification to determine that the foreign supplier is engaging in processes relevant and appropriate to the importation of safe foods. This includes ensuring that the foreign supplier has implemented and is following HARPC and other related food safety regulations. The actual verification process of the Importer can vary based on the foreign supplier, the foods being imported and the nature of the hazards identified. Verifications activities include sampling and testing of food and review of the foreign supplier's food safety records. In all cases, the Importer should document the verification activities and integrate the verification activities and records into their own HARPC food safety plan. The default verification activity is an annual on-site audit of the supplier's facilities to confirm compliance with the Importer's FSVP and all applicable FDA regulatory standards.
  4. Perform appropriate activities as the nature of the food and identified hazards demand based on the realities of the business. Importers, for example, do not need to conduct supplier verification for hazards that are to be controlled later in the distribution chain in the U.S. In such cases, the Importer must nonetheless document this in its HARPC food safety plan and obtain written assurance that the hazard will be controlled for by that customer or, if by an entity further down the distribution chain, that the customer will itself assume the obligation to obtain assurance that the hazard will be controlled for. Furthermore, the new Rule requires the Importer to disclose to the customer the existence of the hazard and that the food has not yet been processed to control for that hazard.
  5. Conduct corrective actions where: (i) an identified hazard is realized and a food product is adulterated or misbranded; or (ii) an Importer learns that a foreign supplier is not producing the food in compliance with the same public health protection as those required domestically under food cGMPs, HARPC food safety plans and the new Produce Safety Rule.
  6. Identify themselves as the Importer of the food for each line of food product offered for importation into the United States.
  7. Retain records of FSVP activities.

These responsibilities represent significant costs for both Importers and the foreign suppliers they use. Implementation of the FSVP programs requires two parallel sets of activities. The domestic Importer must create its HARPC food safety plan, including the implementation of the HARPC supply chain verification processes. These steps require food manufacturers, holders, processors and packers to be aware of each step in the supply chain that provides raw ingredients for the products they make, and be responsible for ensuring that each ingredient is safe and wholesome for human or animal consumption. With the implementation of FSVP requirements, this also includes foreign suppliers. The second step is the creation of the internal procedures and personnel to ensure foreign suppliers are similarly compliant with HARPC food safety plan requirements, as well as documenting the verification activities.

The final Rule will be enforced 18 months after publication. The FDA, during a Nov. 23, 2015 conference stated that FDA inspections after the effective date will include checks for compliance with FSVP integration with HARPC food safety plans for those companies that import food or food ingredient products. Furthermore, with HARPC food safety plan compliance dates less than a year away and considering the integrated nature of FSVPs within HARPC food safety plans, it is vital that importing food companies begin the process of creating these processes and procedures and contact regulatory counsel early and often, as soon as possible in order to ensure timely compliance.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Thompson Coburn LLP
Holland & Knight
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Thompson Coburn LLP
Holland & Knight
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions