FDA Presses Pause on FSMA

By Roland McReynolds, CFSA Executive Director

The US Food and Drug Administration (FDA) made several big announcements recently that will slow the enforcement of rules for safely growing produce under the Food Safety Modernization Act (FSMA). These delays are welcome by the entire produce industry, and farmers hope that these are first steps in reforming FDA’s approach to regulating the production and marketing of fruits and vegetables.

On Sept. 13, FDA published a proposed rule that would extend the deadlines for farms to comply with rules about water used in crop production. Although most of the FSMA Produce Rule comes into effect beginning in January 2018, the water standards currently take effect in Jan. 2020 for farms with over $500,000 in produce sales; Jan. 2021 for farms with sales over $250,000; and Jan. 2022 for those with sales less than $250,000 but greater than $25,000. The new proposed rule shifts each of those deadlines another two years down the road, to 2022/2023/2024. FDA is taking comments on the proposed rule until Nov. 15. If the agency’s review of comments goes quickly, the extended timeframe could become official early in 2018.

The day before, in a speech at a meeting of the National Association of State Departments of Agriculture (NASDA), FDA Commissioner Dr. Scott Gottlieb promised that Produce Rule compliance inspections for the largest farms, which had been due to start in Jan. 2018, would now be deferred until 2019. FDA published the final Produce Rule in 2015, but has not yet published promised guidance documents that would help farms and state governments understand how to interpret the language of the rule.  State departments of agriculture have become increasingly concerned that they won’t be able to fairly apply the rule without this kind of guidance and training for their inspection staff.

And finally, FDA issued a fact sheet addressing a major scientific flaw in the water rule that had water quality experts in an uproar. Essentially the agency provided a list of laboratory test methods it will accept, in addition to the one very expensive and rare one it named in the text of the Produce Rule.

These adjustments are important, but by themselves are not enough to avoid the debilitating punch coming for U.S. farms and food makers from FDA’s current FSMA scheme. For example, the water rules are incredibly complex and open to interpretation, with testing targets that are not supported by water quality science. CFSA and dozens of other farm groups, along with researchers and state officials, have been saying since the draft water rules were published in 2013 that the FDA approach needs to be scrapped (an article published in Food Safety Magazine last month ably summarizes the scientific concerns). Simply delaying rules that will be impossible for many farms to comply with forces the inevitable reckoning down the road, but won’t stop it from ultimately happening.

In announcing the proposed water rule extension, FDA stated it “plans to engage with stakeholders to learn more from farmers, state regulatory partners and other stakeholders about the diverse ways water is used and ensure that the standards will be as practical and effective as possible for all farming operations.” Whether that intention includes a genuine willingness to give up the unjustified burdens in the current water rules remains to be seen.

FDA must shift its approach and create a system that supports farms of all sizes to implement realistic food safety risk management, instead of its apparent focus on building legal tools for prosecuting farmers.

Even without interpretation standards, inspector training programs, or approved regulatory training materials written in Spanish, FDA has been moving forward with its plan to start enforcing FSMA. It has doled out millions of dollars to state governments to fund creation of state-based FSMA compliance programs, and has kept representatives from agriculture at arms-length on those plans. As a result there has been poor transparency about what farms can expect, and confusion among states, as the main Produce Rule compliance deadlines loom. And in exchange for its money, FDA has forced states to start compiling ‘inventories’ of all the farms that could possibly grow produce, including so-called exempt farms, raising huge questions about the privacy of farm information and adherence to Congressional protections for farms that were written into FSMA. No one really knows what FDA will do with its new Produce Rule authority when it kicks in, but the examples from the agency’s history in food safety regulation are discouraging.

Certainly putting off the first official enforcement of the Produce Rule makes good sense, and farmers will be glad to take this much progress. But more is needed: FDA must shift its approach and create a system that supports farms of all sizes to implement realistic food safety risk management, instead of its apparent focus on building legal tools for prosecuting farmers.

Any farm that grows crops covered by the Produce Rule needs to start preparing for how to handle the day when a government inspector shows up to do a FSMA inspection. A great place to start is the two-hour workshop on a farmer’s rights and responsibilities in such a visit that we are presenting at this year’s Sustainable Agriculture Conference. And CFSA’s Local Produce Safety Initiative provides a variety of resources to help farms improve food safety practices.

The incredible efforts of farmers and sustainable agriculture advocates have made a difference in shaping FSMA every step of the way, winning important protections for local food and ensuring key parts of the rules are grounded in science. But fixing FSMA is not a marathon, it’s an ultra-marathon. We have to continue to press the states, the FDA and Congress to make the rules sensible, and protect farmers and food entrepreneurs’ ability to bring healthy, sustainable, local foods to more people.

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.

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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

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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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Food Safety Modernization Act

farm-bill-slideBackground

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

gaps-2015

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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