What the New Rules of the Food Safety Modernization Act Mean for Sustainable Ag

By Roland McReynolds, CFSA Executive Director

A huge portion—maybe a majority—of the businesses serving local and regional food markets will face a new, higher level of food safety bureaucracy and paperwork beginning in September 2017, thanks to the Food Safety Modernization Act (FSMA).FSMA

On September 10, 2015 the U.S. Food and Drug Administration (FDA) issued final rules establishing new ‘preventive controls’ standards for food processing facilities and animal feed manufacturers under FSMA.  Beginning September 17, the timelines for compliance with the Preventive Controls Rules (PCR) started counting down: businesses with 500 or more employees must come into compliance within one year, those with less than 500 employees but over $1 million in sales will have two years, and those with less than $1 million in sales with have three years.  Five other FSMA regulations are due for publication over the next several months.  Together, these rules create new obstacles for farmers and food businesses to sell fruits, vegetables and value-added foods in local and organic product markets.  The PCR for human food is the most complex and far-reaching of them all.

Sustainable agriculture has fought through two rounds of public input to make the rules practical and appropriate to the scale and nature of local and regional food and farming businesses, and the final rules show that those determined efforts made an impact. But substantial threats remain—most importantly, the requirement for food facilities to prove that their suppliers comply with FSMA; in direct contradiction of the FSMA statute, the PCR in effect requires farms and food makers to pay for third party audits.  This requirement—known as supply chain verification—alone may bring the expansion of local food into mainstream distribution channels to a screeching halt.


New definitions of what counts as a farm and the types of things that farms can to do to prepare their crops for market post-harvest look like improvements from previous drafts of the regulations.  With these changes, the new PCRs allow farmer cooperatives to continue to operate as extensions of farms, instead being treated the same as giant-scale food manufacturing plants.

For other forms of food hubs and value-added processing facilities, the impacts remain to be seen.  There are many gray areas and ambiguities in the rules.

Supporters of sustainable agriculture will need to continue to fight to ensure common sense application of these new rules.

CFSA is a member of the National Sustainable Agriculture Coalition (NSAC), which issued a press statement highlighting areas of the rule where improvements have been made, and where additional clarity is needed to ensure the rules do not unfairly require farms to undergo third party audits.  NSAC also urged FDA to quickly finalize a related rule clarifying how farms and food businesses serving direct-to-consumer markets will be covered under the PCRs.  You can read the press statement here.

Combined, the PCRs for human food and for animal feed total over 1,500 pages.  CFSA staff and our allies are undertaking a thorough review of the rules over the coming weeks, and will publish more analysis on specific provisions on an ongoing basis. In addition to the supply chain verification requirement and farm definition, we will be looking closely at several key issues:

  • Definitions related to farming operations and activities that may trigger the facility definition;
  • Classification of various value-added activities, and the corresponding exemption for those activities classified as low-risk;
  • Requirements for so-called ‘exempt’ facilities – including the process for withdrawing and reinstating an exemption;
  • Requirements for facilities to conduct environmental monitoring and product testing; and
  • Compliance timelines for facilities that must register with FDA and comply with the rule.

NSAC will also be updating its “Am I Affected?” flow chart to help farms and food businesses assess whether the PCRs apply to their operations.

One of several flowcharts developed by NSAC to help farmers determine if FSMA applies to them.

One of several flowcharts developed by NSAC to help farmers determine if FSMA applies to them.

You can access the pre-publication version of the final rule here (PDF), as well as via FDA’s website, which includes additional supporting materials.

The next important FSMA milestone is publication of the final Produce Rule, due by late October 2015, which will establish minimum requirements for the ‘safe’ production of fruits and vegetables on farms.  More about FSMA implementation and background information on the proposed PCRs is on our website.

In every round of the struggle over FSMA, sustainable ag has influenced the process effectively, and won concessions to common sense.  As the final rules are put into practice, we will still need to steer the implementation in favor of practical, reasonable requirements that will allow local, organic food to continue to grow and thrive.  Please stay connected with CFSA to learn more about what still can, and must, be done to protect sustainable agriculture.

EXPERT TIP: Enhancing the Safety of Produce through Water Use

By Patricia Tripp, CFSA’s Local Produce Safety Coordinator


Water is a basic necessity of life and is essential in the production of fresh fruits and vegetables. Not only is water used for irrigation purposes in agriculture, it is often used for cleaning purposes before marketing the produce. Water may also be used to protect crops from frost or to apply fertilizers or pesticides. Ensuring that you have clean water on the farm for these practices is an important part of minimizing contamination by disease causing micro-organisms called pathogens. Water can carry pathogens such as Giardia, Cryptosporidium, Norovirus, Salmonella, and E. coli 0157:H7 Learn More

CFSA’s Fight for Food Safety

Background Information 

At the Carolina Farm Stewardship Association, we believe that local and regional food networks do the best job of protecting your family’s health and safety because they deliver fresher, more nutritious foods. That’s why it’s so important that we protect our small and organic food producers from being crushed by regulations meant for industrial farms and factories.


Making ‘Food Safety’ Safe for Small Farms and Local Food

In 2010, CFSA helped lead the successful effort to protect small farms and businesses serving local food markets from new federal authority under the Food Safety Modernization Act (FSMA). FSMA gives the US Food and Drug Administration new powers to dictate farming practices for fresh produce, and to put a wide range of food-making businesses out of business. But the legislation was just the first step.


In 2013, the FDA published proposed rules for implementing FSMA.  These rules were badly flawed and threatened to put many small, sustainable farmers out of business.  CFSA and our allies rallied farmers, entrepreneurs and consumers nation-wide to protest these bad proposals—over 20,000 comments poured in demanding major changes.  In another huge victory for our movement, FDA went back to the drawing board.


In fall 2014, FDA issued revised proposed regulations relating to several key issues, including the use of compost and manure, food hubs and cooperatives, the definition of a farm, water standards, animal feed, conservation practices and record-keeping.  Again, CFSA and other sustainable ag organization’s rallied local organic farming supporters to demand further changes.  The comment period on those rules ended in December, with another 4,000 comments from the public.


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It’s Time to Change the Food Safety Debate

It’s Time to Change the Food Safety Debate
by Roland McReynolds, CFSA Executive Director


On Jan. 4, the US Food and Drug Administration (FDA) published proposed rules to govern the production of raw produce and the processing of most value-added foods.  FDA issued these rules under authority of the Food Safety Modernization Act, or FSMA in government-speak.  This act was billed at the time as the biggest update of our food safety laws since Upton Sinclair’s novel “The Jungle” exposed the horrors of the turn-of-the-Twentieth-Century meatpacking industry.  FSMA explicitly gives FDA wide new authority to set rules for how farmers work many crops, and how food businesses run their operations day-to-day.  With its proposed rules, FDA revealed what it intends to do with that newfound authority.  Anyone who believes in the power of strong local food systems to improve our environment, communities and health should be extremely concerned.

The local, organic food community fought hard, and successfully, to ensure that Congress put protections in FSMA to prevent local foods from being strangled by industrial-scale food safety regulation.  For the first time the federal government acknowledged that the scale and length of supply chains matters when it comes to food and farming, and that one-size-does-not-fit-all when it comes to regulating agriculture.  By limiting FDA’s power to govern farms and food makers predominantly serving local markets, Congress intended that the local food sector should continue to thrive, create jobs, and offer consumers a healthy alternative to faceless, processed food.


Despite that astonishing legislative achievement, we are not out of the woods yet.  FDA’s proposed FSMA rules expose just how fragile the so-called ‘exemptions’ for local food can be in the face of government arrogance.  FDA is proposing loopholes that threaten to swallow completely the law’s local and organic food protections.

Notably, FSMA’s protections generally only apply to businesses with less than $500,000 in annual food sales.  If we want local, healthy food systems to grow, and if we want market opportunities that encourage a new generation of sustainable farmers, we will need businesses – especially food hubs and other collaborative processing and distribution models – that grow beyond that benchmark.  USDA research indicates that to be financially viable, a local food hub needs at least $1 million in annual revenue.


Regardless of whether FDA regulations apply to a particular local farm or food producer, the market will respond by adopting the federal rules as private standards.  Insurance companies and retail outlets will require farms and food makers to comply with FSMA as a condition of market access—unless we take the initiative to create a safety protocol for local, organic food that is tailored to address the actual risks it presents.

On one hand, the bare minimum protections we won in Congress put a target on our backs.  Many so-called consumer advocates are on the attack, charging that local food and small farms are risky and dangerous because they won’t be subject to FSMA.  This PR blitz is a significant threat.  On the other hand, FDA’s rules don’t go far enough to implement Congress’ intent to support local alternatives.  To meet these twin challenges, the local, organic farming movement needs to change how our nation talks about food safety.

Every farmer and food maker is either a parent or a child, if not both, and can relate to the tragedy of a losing a loved one.  As a parent, I dread the chance that food I prepare for my children with my own hands might cause them harm.  No farmer or food maker wants to cause pain with the foods they create.  Local food producers agree that they should take effective steps to prevent doing harm to their customers, and they realize that the impact of foodborne illness can be terrible.  It’s not a subject of dispute.  However, it is intellectually dishonest and manipulative when FDA officials and purported ‘consumer advocates’ attempt to cut-off debate about appropriate food safety regulation by evoking the sheer tragedy of a small number of foodborne illness incidents.

Once we move past that sanctimonious grandstanding, there are three premises that our society must accept in the discussion about food safety.  The first is that we cannot achieve zero risk.  Even if we irradiated, baked and boiled  100 percent of the food we eat, pathogens will get through somewhere on the journey from field to processing facility to retailer to kitchen to plate, and people will get sick.  Microbes are everywhere and hoping to get ahead of Mother Nature through technology is to take the same dead-end approach to food safety that chemical agriculture has lead us in food production.  Indeed, many of the interventions we can pursue to limit pathogens will have other negative health consequences because they reduce the nutritional value of food.

Second, we live in a world of finite resources.  Governments, large corporations, small business and consumers all must make choices about how to allocate limited time and dollars to address problems.  There is only so much money the government can raise to fund food safety enforcement, and small enterprises that want to stay in business cannot spend more to limit pathogens than what the market will pay them for food products.  What’s more, given the fact that we cannot reach zero risk, we must recognize there are diminishing returns to additional public and private food safety investments.  Beyond a certain point they are ineffective and counterproductive.

The third principle is that fresh, local, organic food has disproportionate positive impacts on our society.  Better diets lead to less heart disease, less obesity, less chronic illness, and happier, healthier lives.  Reducing diet-related illness reduces public health care costs.  Money recirculated within our own communities makes our economies more resilient, and healthy economies support healthy people.  We know that our diet in this country is killing us.  Fifty-thousand Americans die every year from colon cancer, almost 250,000 from complications of diabetes, and 800,000 from heart disease.  Our diet may be the gravest threat to human health in the US today, the effects of which we will be coping with for another generation or more.  Local food systems will be huge in overcoming that threat, and from this perspective, we must evaluate the cost of further regulatory impositions on local food producers.

I say ‘further’ impositions, because one fact that is lost in the discussion of so-called food safety ‘exemptions’ for local food is that these folks are already heavily regulated.  From county health departments’ oversight of farmers markets, to licensing and inspections for low-risk processed foods, to good manufacturing practices, and more, local food producers are already laboring under a patchwork of rules and regulations.  FSMA’s protections for local food are really about recognizing that this existing legal framework is already working quite well, albeit at a significant cost of compliance to producers and relatively low cost of enforcement for government.

It makes no sense to apply rules designed for complex, national and international food supply chains to the inherently short supply chains that characterize local food distribution.  By their nature, local, diffused supply chains impose limits on the potential for contamination and the extent of foodborne illness outbreaks.   Safety rules must take that into account if they are to be efficient and effective.

When we proceed from these principles, we can actually start to have the conversation about how we allocate limited resources to reduce the risk of foodborne illnesses.  There must be a cost-benefit analysis if we want food safety law to improve public health.  And I say ‘improve public health’ deliberately.  The local, organic movement is not about building a food system that merely avoids killing us unexpectedly.  It is about building a food system that helps us live better.

This article was originally posted on http://rodaleinstitute.org/2013/time-to-change-the-food-safety-debate/


Food Safety Modernization Act


Passed by Congress in 2010 and signed into law in 2011, the Food Safety Modernization Act (FSMA) is the first major overhaul of our nation’s food safety practices since 1938. The law includes new regulations for farms that grow fresh produce (fruits and vegetables) and for facilities that process food for people to eat. This means it represents some big changes to our food system –FSMA gives the FDA broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods.

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Good Agricultural Practices (GAPs) Consulting


CFSA offers one-on-one training to help North and South Carolina growers become USDA-GAPs certified

Take advantage of our one-on-one training opportunity to have a mock audit conducted on your farm.  This training will help you identify potential risks and get an assessment of your current practices in relation to the GAPs certification matrix.

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