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How this Proposed FDA rule threatens small farms and food businesses

by Stephanie Phelan
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Food Safety Modernization Act (FSMA)

hands washing greensAbout 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases (according to recent data from the Centers for Disease Control and Prevention). This is a significant public health burden that is largely preventable. The FDA Food Safety Modernization Act (FSMA), was originally signed into law by President Obama on Jan. 4, 2011 – and it “enables the FDA to better protect public health by strengthening the food safety system”.

Tester-Hagan amendment

Eight years after the Food Safety Modernization Act (FSMA) was passed by Congress, the Tester-Hagan amendment started coming into focus. Its purpose is to “exempt small producers serving only local markets from all the preventive food safety standards that the Food and Drug Administration would be imposing.” 

While the Food Safety Modernization Act (FSMA) included the “Tester amendment” to exempt small-scale farms and food businesses from many of its provisions, the exemption doesn’t specifically apply to the provision for additional traceability requirements on high-risk foods. For foods that FDA lists as “high risk,” the proposed rule imposes extensive:

  • Record-keeping requirements, including electronic spreadsheets
  • GPS coordinates of where the foods are grown, the location, date and time that the food is harvested, cooled, packed, shipped, or used as an ingredient in another food.

The list of foods that FDA considers to be “high risk” includes soft and semi-soft cheeses, eggs, seafood, leafy greens, herbs, tomatoes, and more. See the entire list in the proposed rule here. 

Pros and Cons to the Amendment

variety of vegetables for saleThe FDA has now expanded the scope of this “high risk foods” provision to cover everyone who manufactures, processes, packs, or holds food.  And the agency interprets those terms to include people who grow the food, i.e. farmers.

These changes aren’t necessarily bad for the industries involved, we need health regulations in order to protect society from foodborne illnesses. Plus, there are still exemptions for small scale farms that are unable to adapt as quickly as larger, more industrialized farms. While there isn’t enough data yet to consider local farms (serving produce to consumers within 275 miles) to be “safer”, many of these farmers voluntarily work to meet new requirements, even though they may be exempt in some ways. In fact, according to this survey:

  • 86% of the list surveyed has a personal commitment to produce a safer product
  • 82% are working towards reducing exposure to lawsuits
  • 79% are trying to maintain market access and meet buyer requirements

So, are we experiencing pushback because it will force businesses to change and they don’t want to?

Or is it due to costs associated with meeting this new requirement and negative effects to the current farming operations?

Rather than make an assumptive decision for you, TexasRealFood would rather give you the necessary information from both sides. Most health advocates recognize that FSMA is a genuinely progressive piece of legislation with many new benefits and powers. Since its passage, here are the PROS:

  • The FDA has shifted its regulatory approach from reacting to food safety problems to preventing them. 
  • FSMA articulates food safety objectives that were once vague, and clarifies compliance expectations through guidance and training. 
  • The FDA’s ability to identify, track, and trace particular strains of pathogens back to their sources has improved due to new testing methods (we are able to identify specific foods AND farms that are causing the issue).
  • The FDA can now suspend a facility’s registration and shut down its operations if it does not respond swiftly and effectively to a food safety concern that puts the public at risk.

 On the negative side, FSMA has weaknesses or CONS:

  • The FDA is incapable of full enforcement for lack of funding, staffing, inspections, and education (something that is out of our control as farmers or consumers)
  • The FDA must, therefore, rely on other agencies for enforcement assistance, increasing complexity, redundancy, and gaps in communication.
  • The costs for small farms to comply with some new changes to FSMA.

New changes to the FSMA

statue of the goddess themisThe FDA is now proposing a new rule that would apply to almost everyone involved in the food system, including farms, cottage food operators, co-ops, and restaurants.

The agency has proposed some exemptions:

  • Food grown or made solely for personal use.
  • Farms that sell $25,000 of less of produce annually.
  • Businesses that sell $25,000 or less of food annually.
  • Egg producers with less than 3,000 hens.
  • Nonprofit food establishments, such as food banks or soup kitchens.

Even if your farm or food business falls within one of these narrow exemptions, you might still find yourself required to keep extensive records. That’s because the agency is requiring “first receivers” –  businesses that receive the food items from the original person who grew or made them – to keep extensive records on where it was grown/made, when it was harvested/manufactured, etc.

Farmers Taking Action

The FDA was accepting comments online with a deadline to submit being Monday, February 22, 2021, at 11:59 pm Eastern Time.

A sample comment was given here to help advocates craft their own comments. You can read about some struggles and backlash being faced by farmers. You can also find more related material here through Science Direct  – it’s very important to do research and form your own opinion! By laying out the pros and cons, TexasRealFood hopes to be able to guide local farmers and producers in Texas (and beyond!) – to help navigate this upcoming journey that will ultimately be beneficial to everyone involved.

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