Each year, according to the findings of a Center for Disease Control and Prevention study, 48 million people (1 in 6 Americans) get sick, 128,000 people are hospitalized, and 3,000 people die as the result of food-related diseases. Instead of reacting to this news on a yearly basis, the U.S. Food and Drug Administration (FDA) decided to do something about it (although not fast enough, some would say) by enacting the Food Safety Modernization Act (“FSMA”). This law, which went into effect on January 4, 2011, aims to protect public health and ensure food safety by placing a greater emphasis on prevention, compliance, and enforcement.
We’ve summarized the seven foundational rules of FSMA for you below. The compliance elements which food facility owner/operators, growers, suppliers, importers, consignees, carriers, and/or accreditation/certification bodies should, at a minimum, incorporate into their 2017 actions plans are highlighted in red (information regarding compliance deadlines for different size-based categories of business can be viewed here). Diaz Trade Law has extensive advising clients on FDA matters and welcomes the opportunity to help your company get FSMA compliant.
* PC Human supply chain compliance deadline is 3/17/17 (general)/9/18/17 (small) or six months after supplier is required to comply with applicable rule. PC Animal supply chain compliance deadline is 9/18/17 (general)/9/17/18 (small) or six months after supplier is required to apply with applicable rule.
**Farms have additional two years to comply with certain water-related requirements. Separate compliance date for sprouts.
*** Very small importers and importers of food from very small suppliers are subject to modified requirements.
**** 3PAC provisions are effective as of the date of the final rule but cannot be implemented until the publication of the forthcoming Model Accreditation Standards.
These rules change the game, in a way that moves both compliance risk and enforcement potential to a whole new level, for the farms, ranches, facilities, logistics providers, and accreditation bodies that directly or indirectly comprise the US food industry.
The most crucial aspects of adapting to and managing this new reality entail (i) mastering the who, what, when, and where associated with the FSMA and (ii) developing and implementing the appropriate action(s). Based on our prior experience working with clients on FDA issues, the best advice we can provide entities coming within the scope of the FSMA is, as a matter of default operating orientation, to get the PICTURE:
“P” – Be Proactive – The FSMA shifts the compliance and enforcement paradigm from being reactive to being proactive. Don’t get caught flat-footed.
“I” – Stay Informed – The FSMA introduces new standards and practices and has lots of moving parts. There is already a lot of information out there, some of it good, some of it questionable. Identify and rely on trusted and experienced sources to help you navigate your company to a secure position.
“C” – Get Compliant – This is the heart of the FSMA. Write the plan and/or take the measures required for your company. If you find this confusing or overwhelming, retain the assistance of counsel with demonstrated FDA experience.
“T” – Train – The FSMA establishes extensive training opportunities. These are in addition to the wealth of educational resources and guidelines otherwise available on FDA websites. Use these to your advantage, in the spirit of reasonable care.
“U” – Use Good Judgment – The written compliance activities required of entities coming within the ambit of the FSMA can, to the extent they provide insight into company-specific procedures and practices, inadvertently create liability exposure. Be judicious in balancing compliance and confidential operating information. Always, as a hedge against undesired downstream FOIAs, characterize documents filed with the FDA as business proprietary. If you have doubts or questions in this regard, give us a call. We have the experience and knowledge to help.
“R” – Recordkeeping – It’s required. And knowing what’s required to keep could save you a lot of time and money down the road.
“E” – Embrace Technology – Whether video, GPS, water quality test kits, etc., there is an almost never-ending tide of technological applications that can be harnessed for the purpose of better ensuring your company’s compliance. It’s never been easier to work smart – and efficiently. Which goes a long way to avoiding costly issues with FDA.
In its fleshed out form, the FSMA is a far-reaching and complicated body of regulation whose standards and procedures should not be taken lightly. The dictates of prudent practice and reasonable care weigh in favor of retaining expert counsel. Let us know if you have any questions!