Food Safety Modernization Act

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Background

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 – and it is extremely important for the Food and Drug Administration (FDA) to get these regulations right so that they improve food safety without placing an unfair burden on family farms and our developing local 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.  To do so, FSMA authorizes new regulations for farmers who grow certain kinds of fresh produce (fruits and vegetables) and for certain facilities that process food for people to eat.  The regulations focus on addressing food safety risks from microbial pathogen contamination (e.g., Salmonella, E. coli O157:H7, and Shigella).

Specifically, FSMA requires FDA to establish new regulations for:

·   Standards for produce production (Produce Rule), and
·   Food safety measures for facilities that process food for human consumption (Preventive Controls Rule).

As of March 2015, FDA is currently in the rulemaking stage – turning the FSMA bill passed by Congress in 2010 into actual rules and regulations that will affect farmers, food businesses, and everyone who eats food. The opportunity for the public to comment on FDA’s proposed rules ended in late 2014, but the rules are not yet final, and are not yet being implemented on the ground on farms and businesses.

 

Current Situation

FDA Is Reading Your Comments

Before FDA can finalize the proposed rules, the agency needs to read the input it received in 2014 from the public. Comments from consumers, farmers, on-farm processors and food businesses will directly shape the final rules and were critical to ensuring that the final rules work for small and mid-sized farmers, sustainable and organic growers, value-added businesses and conservation systems.

Thank you to everyone who submitted a comment!

 

Take Action

If you have a chance to speak to a member of your US Congressional delegation, please let them know that you are concerned about the FDA’s FSMA rules. 

Let your Congressional delegation know about the problems with the FDA’s proposed rules and ask for their help in making sure that the FDA publishes rules that preserve safety AND preserve local, organic farms.

1. Issue: Definition of a “Farm”

The final rules don’t provide a clear definition the term ‘farm.’ FDA must clarify the difference between a farm and a facility using common sense and risk-based distinctions that have clear connections to promoting food safety. Specifically:

• FDA should clarify the “farm” definition to ensure that farmer-operated businesses that engage in “farm” activities — growing, harvesting, packing, or holding raw agricultural commodities — are considered farms.

• FDA should remove the phrase “in one general physical location” from the farm definition, to reflect the modern-day reality that farms are not always contiguous, and that farms may include structures in different locations or on different parcels of land.

2. Issue: All Food vs. Regulated Food

In the final regulations, FDA should provide clarity and consistency across the rules for farms and food businesses covered by the rules. To do so, FDA should base all calculations used to determine whether and to what extent a farm or food business is covered under the rules on sales of what the rules regulate. Specifically:

• For all coverage determinations, FDA should base thresholds on sales of either “covered produce” under the Produce Rule, or “covered human food” under the Preventive Controls rule.

3. Issue: Protections for Local Farms and Food Businesses (Qualified Exemptions and Modified Requirements)

The process to get an exemption from or modification of FSMA requirements should be the same under both the Produce and Preventive Controls Rules, and the content of a withdrawal notice or order should clearly state the individualized nature of the determination. Specifically:

• FDA should ensure that both rules follow a clear and consistent process.

• FDA should never withdraw a farm or business’ qualified exemption without specific proof that that specific entity has caused or presents a verifiable threat of causing serious adverse consequences to human health.

• FDA should include – in both the initial notice of intent to withdraw and the withdrawal order itself – facts specific to the business that holds the qualified exemption, to ensure that each withdrawal is made on an individualized basis and that the farmer or facility has a meaningful opportunity to rectify the situation.

• FDA should retain the reinstatement process, and should clarify that FDA will reinstate an exemption within a reasonable period of time.

 4. Issue: Agricultural Water

FDA must not overly burden farmers to test and address water quality issues outside of their control. FDA must take a science- and risk-based approach to agricultural water that provides clarity and flexibility to allow farmers to respond to specific risks in their water systems, and should defer finalizing a numeric water quality standard until a full risk assessment is completed. Any numeric standard should be in guidance, not regulations, to provide an ongoing mechanism to adjust the standard to reflect new science and to provide meaningful opportunity for farms to offer input. Additionally:

• FDA should reduce the frequency of testing. As currently proposed, the testing frequencies are overly burdensome, lack scientific justification, and will impose great costs on farmers to repeatedly test the quality of water that will remain impaired for reasons beyond their control.

• For water sources that are outside the farmer’s control and consistently exceed the standard, or water sources that are controlled and consistently satisfy the standard, FDA should provide the farmer with the flexibility to determine the number of tests needed to establish a baseline and characterize the water quality profile of the source.

• FDA should align with the USDA GAPs standard, and limit testing frequencies to three samples per growing season.

5. Issue: Manure and Compost

As FDA undertakes this research and risk assessment approach to regulating raw manure and supporting compost use, the sustainable and organic farming community must be engaged as stakeholders and advisors in this process. Specifically:

• FDA should form two advisory boards – one that advises the process and one that reviews the science. Both boards should have members representative of the diversity of American agriculture, including sustainable and organic farmers and the researchers that work with them.

• To align with current best management practices and support the increased use of compost, insulation of compost should not be required as part of acceptable compost treatment processes.

• We support FDA’s decision to not take exception to farmers adhering to the National Organic Program application interval for raw manure until such time as the risk assessment is completed, a new standard is proposed for public comment, and an interval finalized after considering public input.

6. Issue: Conservation Practices

FDA should incorporate stronger incentives into the rule for on-farm conservation that supports food safety and protects our soil, water, and wildlife habitat. Specifically:

• FDA should state in the final regulations that farmers are encouraged to use sustainable conservation practices that enhance food safety. FDA should also specifically identify co-management of conservation and food safety as a type of activity that is not prohibited by the rules.

• FDA should define co-management in the regulations.

• FDA should not treat grazing like manure application and should not restrict grazing through unrealistic intervals, such as nine months, between grazing a field and harvest of a crop.

7. Records and Recordkeeping Requirements

Records should be limited those kept in the ordinary course of business, particularly records required of farmers that pack or hold produce from other farms. Specifically:

• FDA should require farms that pack or hold produce from other farms to retain, for no more than one year, a one-up-one-down record, not to exceed that kept in the ordinary course of business, such as an invoice.

• FDA must allow records to be written or on paper; FDA cannot require electronic records.

8. Issue: Supplier Verification Program

FDA must follow the law and remove the onsite audit requirement from the supplier verification program. FDA should also remove the supplier verification program from the Preventive Controls rules. FDA must ensure flexibility for farms and food businesses, and that produce farms subject to the Produce Rule are not subject to multiple and duplicative compliance requirements.

9. Issue: Excessive Compliance Costs (Environmental and Product Testing) 

FDA should find ways to decrease the costs of compliance with the new rules, especially for small and very small farms. Specifically, FDA should provide flexibility for farms and food businesses by including environmental and product testing in guidance for public comment, not the regulations.

10. Issue: Direct-to-Consumer Marketing

In the final regulations, FDA must clarify that CSAs, roadside stands, farmers markets, and other direct-to-consumer vendors fall under the definition of a “retail food establishment” and are not facilities that must register with FDA and, therefore, are not subject to the Preventive Controls Rule. Specifically:

• FDA must issue the separate rulemaking on the retail food establishment clarification immediately, to allow sufficient time for the public to review and comment while still finalizing the clarification no later than when the rules themselves are finalized.

 

 Stay Informed  

CFSA will issue regular updates and information on this website as we analyze the rules’ impact on sustainable farm and food systems.

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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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