NOTE: FDA did not re-propose this section of the proposed FSMA rules; this text is up to date as of October 2014.
Background
Certain private-sector food safety regimes have focused on setting food safety standards for a specific commodity. For producers who grow only one commodity or a small handful of commodities, this approach may be feasible. For farmers who grow many different types of crops, however, a commodity-specific approach to food safety would impose high costs and would be untenable. Implementing, monitoring, and maintaining records for dozens of different fruits and vegetables on one farm would effectively discourage diversification and limit the options available to growers.
When writing the Food Safety Modernization Act (FSMA), Congress recognized that many farmers grow a variety of different fruits and vegetables. In FSMA, Congress required the Food and Drug Administration (FDA) to minimize the number of separate standards that apply to separate foods, and Congress required FDA to provide flexibility in the new regulations so that they were workable for all sizes and types of farm businesses.
Integrated Approach
In its proposed Produce Rule, FDA has tentatively taken an “integrated approach” to the standards and, apart from sprouts, is not setting specific standards for different fruits and vegetables. That means that for produce covered by the proposed regulations, farmers must follow the standards (unless they are eligible for modified requirements) but there are not separate standards for different crops. The one exception is for sprouts, and there are specific regulations that apply to the growing, harvesting, packing, and holding of sprouts.
This type of approach allows FDA to focus on possible routes of contamination and devise standards to address certain on-farm risks. While there is a long way to go before understanding how to effectively and appropriately mitigate on-farm risks, and while there are significant issues with the proposed standards (see NSAC’s Produce Rule Issue Pages), the integrated approach is the first step in making an appropriate food safety regulatory framework.
The integrated approach is critical to making the produce safety regulations work for diversified farmers. Diversified production systems deliver pest control, fertility, and environmental benefits, as well as allow farmers to diversify their income streams. A commodity-specific approach with a proliferation of separate standards for separate crops would be significant headache for farmers and for regulators, and would discourage diversification.
FDA Needs to Hear from YOU in Support of the “Integrated Approach”:
FDA is very tentative in its decision to take an “integrated approach” to the standards, and the agency is actively seeking comment on the issue. If you are a farmer that grows a variety of fruits and vegetables, or if you care about diversified farming systems, then FDA needs to hear your support for the integrated approach. Single-commodity producers and their associations will be pressing FDA to set commodity-specific standards instead of taking an integrated approach.
Here are some questions to guide your comments on this part of the proposed Produce Rule:
- If you are a farmer, how many different types of fruits and vegetables do you grow? Which produce would be covered by the proposed Produce Rule?
- If FDA chooses a commodity-specific approach, how will that impact the type of farming that you do and your costs of complying with food safety regulations?
- If you support an integrated approach, be sure to say that!
How do I submit a comment to FDA?
Our step-by-step instructions show you how.
Additional Resources
- Preamble discussion of the integrated vs. commodity-specific approach: https://www.federalregister.gov/articles/2013/01/16/2013-00123/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption#h-70
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