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.

Applicability

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.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.