United States: FDA Final FSMA Preventive Control Rules

Last Updated: October 13 2015
Article by Aaron D. Grant

On September 17, 2015, the Food and Drug Administration published the long-awaited final rules to establish requirements for current good manufacturing practices, hazard analysis and risk-based preventive controls for human and animal food as required by the Food Safety and Modernization Act ("FSMA"). These final rules apply to domestic and foreign facilities that manufacture, process, pack, or hold human food, animal feed, or the ingredients used therein and are required to register with the FDA under the agency's existing regulations implements by the Bioterrorism Act.

FSMA Preventive Controls for Human Food

The main thrust of the final rule for Preventive Controls for Human Food is unchanged from prior versions; that is, a shift to Hazard Analysis and Risk-Based Preventive Controls. Food manufacturers and processors required to register with the FDA are tasked with identifying their significant hazards with the potential to cause illness in humans and animals and developing a Food Safety Plan to control those hazards. Ongoing monitoring and record keeping related to the Food Safety Plan is also mandated. While the main thrust of the rule has not changed, the final rule does have some important clarifications and additions discussed below.

Flexibility for Oversight & Management of Preventive Controls – Rather than take a "one size fits all" approach to monitoring hazards, the final rule will permit monitoring to be tailored to fit each particular preventive control. An example provided by the FDA is that the monitoring of the actual temperature values used in a heat process designed to kill pathogens would be more frequent and extensive than the simple record keeping of preventive maintenance activities used to minimize metal hazards.

Clarification of the Definition of a "Farm" – The FSMA definition of a "farm" was clarified and expanded to include a "secondary activities farm," which is defined as an operation not located on a "primary production farm" that "is devoted to harvesting packing and/or holding raw agricultural commodities." The "secondary activities farm" must be majority owned by the "primary production farm" that supplies the majority of the raw agricultural commodities harvested, packed, or held by the "secondary activities farm."

Supply Chain Program Flexibility – The rule requires that a covered manufacturing/processing facility ("Facility") have a risk-based supply chain program for those raw materials or ingredients for which the Facility has identified a hazard requiring a supply-chain applied control. However, those Facilities that control the hazard using preventive controls or who appropriately rely on a customer to control the hazard do not need to have a supply chain program for that hazard. Furthermore, a Facility will not be required to implement a preventive control when an identified hazard will be controlled by a subsequent entity in the supply chain, such as a customer or processor, so long as the food is identified as one "not processed to control (identified hazard)." Additionally, the Facility must have obtained written assurance from the subsequent entity regarding the actions to be taken to control the hazard down the line. A Facility may also shift the responsibility for conducting supplier verification activities to another entity in the supply chain, such as a broker or distributor, so long as the Facility reviews and assesses that entity's documentation of the supplier verification.

Additional Binding Provisions Added to Current Good Manufacturing Processes ("CGMP") – Formerly non-binding provisions, such as those related to employee education and training, are now binding. Management is now required to ensure that all employees involved in manufacturing, processing, packing or holding food are qualified to perform their assigned duties. These employees must also receive training in the principles of good hygiene and food safety, including employee health and hygiene.

FSMA Preventive Controls for Animal Food

Establish CGMPs for Animal Food Production – The final rule establishes baseline CGMPs for animal food production that arguably provide greater flexibility than those related to human food. With that said, animal food processors already implementing human food safety requirements do not need to implement additional preventive controls or CGMP regulations when supplying a by-product for animal food, except to the extent needed to prevent physical or chemical contamination of the by-product. Further processing of a by-product for use as animal food, however, does require Facilities to process the by-product in compliance with CGMPs. In such a scenario, the Facility can elect to follow either the animal food or human food CGMP.

Covered Facilities Must Adopt a Written Food Safety Plan – The written Food Safety Plan must include the identification of all known or reasonably foreseeable biological, chemical, and physical hazards; the adopting of preventive controls designed to minimize or prevent the identified hazards; a plan for ensuring the efficacy of the preventive controls through monitoring and verification; and, finally, a recall plan in the event the Facility fails to prevent a hazard to its animal food.

Supply Chain Flexibility – The animal food rule adopts substantially the same flexible supply chain program described above in the Human Food section.

Exempts Vertically Integrated Feed Mills – Feed mills associated with farming operations in which the feed mill, animals, land and establishment are all owned by the same entity satisfy the definition of a "farm" and are generally not subject to the preventive controls for animal food final rule. The FDA, however, has expressed an intent to publish a future proposed rule that would require some vertically integrated feed mills to adopt the CGMPs established by the preventive controls for animal food final rule.

Exempts Bulk Grain Storing Facilities – Bulk grain storage facilities that do not process raw commodities into animal food, e.g. grain elevators, are not subject to the Final Rule. Grain elevators with integrated feed mill operations, however, remain subject to CGMP requirements.

Compliance Dates

The final rules for preventive controls for both human food and animal food become effective sixty (60) days after publication – on November 17, 2015. Businesses are required to be in compliance with the final rule one year after publication – September 17, 2016. However, "small businesses" (those with fewer than 500 full-time employees) are given two years to comply with the preventive controls for human food final rule – until September 17, 2017. "Very small businesses," defined as those businesses averaging less than $1 million per year in both annual sales of human food plus the market value of human food manufactured, processed, packed or held without sale are given three years – until September 17, 2018 – to comply, although they must have records to support their status as very small businesses by January 1, 2016.

Compliance dates for animal food are similar, although slightly more complex. The general date of CGMP compliance is one year for "businesses," two years for "small businesses," and three years for "very small businesses." For the purposes of the preventive controls for animal food final rule, a "very small business" is defined as one averaging less than $2,500,000 per year during the three year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed or held without sale. For each of those three business categories, however, the compliance date for preventive controls is pushed out one year beyond the date of CGMP compliance (e.g. a "small business" has three years to comply with establishing preventive controls).

Finally, the supply chain requirements will phase in over a period starting as early as 18 months after the effective date (for a receiving business other than a small or very small business whose supplier will not be subject to human food preventive controls rule) to as late as three years after the rule's publication date or six months after the supplier is required to comply with the rule, whichever is later, for a small business with a supplier that is subject to the preventive controls for animal food final rule.

Conclusion

While the final rules are not substantially different than the earlier published proposed and supplemental rules, the final rules do start the clock running on Facilities to shift from a more reactive food safety regime to a more preventive, and arguably more onerous, outlook. Facilities are encouraged to familiarize themselves with the rules and begin preparing to implement the rules' requirements as soon as practicable

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.