FSMA 2018 Update

With the effective date of the Produce Safety Rule in January 2018 all 3 food and feed rules are now in use and members of our industry are working hard to implement the requirements and understand the impact to their business.  While the programs and requirements may seem daunting it is very likely that your current activities meet the requirements of your associated rule and, with some ongoing documentation and training, your facility can consistently prove compliance and meet FDA visit requirements when they occur.


Preventive Controls for Human Food

Any food manufacturer required to register for the Bioterrorism Act of 2002 must become compliant with this rule.  The initial compliance dates for large companies was September 2016 and passed without significant issue.  Smaller organizations were expected to become compliant in September 2017 and, as this was the bulk of manufacturers, more challenges were identified with regard to availability of training.  Overall compliance and education continues with moderate success.


Preventive Controls for Animal Feed

Published concurrent with the Preventive Controls Rule for Human Food, this rule impacts all pet food manufacturers and animal feed mills.  Large facilities were tasked with compliance in September 2016 and was met with recognition that the industry as a whole was working diligently but required addition assistance and training.  Recognizing this, FDA has deferred enforcement of many of the food safety requirements, focusing on education and outreach in lieu of punitive actions.  It is important to note that while enforcement may be delayed, expectation of compliance remains.


Produce Safety Rule

Published in January of 2016, the very largest of the those impacted by this rule were required to be compliant in January 2018.  Of the 3 industry sectors the fresh produce industry is by far the most diverse in size and scope.  From individual farm stands to wholesalers and distributors sites must understand the requirements of the rule and the documents necessary to prove compliance.  Understanding of farm site risks and environmental, wildlife and input effects is essential to ensuring your farm is meeting the rule requirements.

FDA FSVP Clarification

In mid January 2018 FDA released additional guidance to assist importers of raw grains with the implementation and management of their Foreign Supplier Verification Program.

Details of the guidance can be found here:

FSMA FSVP Raw Grain Imports


Food Safety Modernization Act (FSMA) – Implication for Feed Safety Enforcement

FSMA, which became law in January 2011, is designed to give FDA more authority to protect the safety of food for humans and animals. It gives FDA new authorities for addressing issues concerning the safety of food for animals and will ultimately … [Continue reading]

Upcoming FSMA Trainings in Lancaster, PA

These classes have been closed to further registration … [Continue reading]

All Natural Advertising

What does All Natural mean to you?  The current adage is ask 10 people and get 10 different answers.  Actually whether you know what all natural means also depends largely upon your background and your knowledge. As anyone who reads this site … [Continue reading]

September is Food Safety Month

September is Food Safety Month which leads us to consider the implications of food safety throughout the supply chain.  For the previous few years the emphasis has been shifting, or perhaps expanding is a better word, toward the farm.  We see more … [Continue reading]

cGMP Implementation Deadline – September 2017

An important portion of FSMA to be implemented by animal feed mills is the application of cGMP’s consistent with the type of feed being manufactured. Some things you should know: The word ‘current’ indicates implementation of rules consistent … [Continue reading]

Is FSMA Going to Change under Trump?

With the inauguration of a new administration focused on reducing regulatory burden there has been much discussion about the potential effects on the Food Safety Modernization Act. Currently there has been no indication of any change of course by the … [Continue reading]

Human Food versus Animal Feed

A common question these days from animal feed manufacturers is whether the FSMA regulation, and FDA themselves, understand the difference between human food and animal feed. There is justifiable concern that regulations are intended to move the … [Continue reading]

The Time is Now!

September 19, 2016 marked the date for the first wave of FSMA implementation for the largest of the food and feed companies under FDA jurisdiction. We should finally begin to have clarity into some of the requirements and expectations of the overall … [Continue reading]