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Second Time's the Charm: The FDA’s Amendment of Safety Regulations for Fruits, Vegetables and other Fresh Produce

posted on Wed, Jul 8 2015 11:40 am by Mathew Swinburne

Produce safety has been a hot topic since President Obama signed the Food Safety Modernization Act (FSMA) into law in 2011. FSMA required the FDA to issue proposed produce safety regulations by January 4, 2012. However, the agency failed to make the deadline and was taken to court by the Center for Food Safety. As a result, the FDA entered into a consent decree which required the agency to finalize regulations by October 31, 2015. 

When the FDA finally released its proposed produce safety regulations, in January 2013, the agency received over 36,000 public comments. The public had a wide range of positive feedback and practical concerns regarding the agency's first attempt to establish science-based minimum standards for the production and harvesting of produce. These concerns included questions regarding (1) how the regulations would affect tribal lands, (2) feasibility of agriculture water safety standards, (3) conflicting safety standards for the application of raw manure, (4) small farm exclusions, and (5) due process protections. The FDA listened to the public and as result issued a proposed supplemental rule, in September 2014, which amended their original proposal.

While the revisions did not address all of the public’s concerns, they did tackle some critical issues. A few important revisions include:

Definition of Covered Farms
The first set of proposed regulations excluded small farms, defined as selling on average less than $25,000 in food annually, from the requirements of the produce rules. Several interested parties, including the Vermont Vegetable and Berry Growers Association, felt this was over inclusive and would unduly burden small farms. To mitigate the economic burden on smaller farms, some argued that the sales limit should be higher or only include the sale of produce, rather than all food items. In response to these concerns, the FDA changed exclusion cut-off to $25,000 in produce sales, rather than all food sales. This increased the pool of small farms that would be exempt from compliance with the regulations.

Water Quality Standards
Several interested parties, including the Pacific Northwest Vegetable Association, were concerned that the FDA’s original proposed agricultural water quality standards were not scientifically based and would create undue burden on farmers. In the supplemental regulations, the FDA updated the water quality standard to a less stringent benchmark. Also, in the revisions, farms with agricultural water that does not initially meet the new standard can still use the water if it is applied with a sufficient time to allow adequate natural microbial die-off before harvesting and/or storage. In addition, the FDA reduced how often agricultural water must be tested. The revisions propose a tiered testing system that looks at the source of agricultural water and its previous testing results to determine testing frequency.

Raw Manure Application
Originally, the FDA proposed a nine-month application interval for raw manure. An application interval is the time between the application of the raw manure and the harvesting of produce. This is intended to allow microbial die-off before the produce is harvested. However, this proposed standard was met with two major concerns. First, this proposed application interval conflicted with the USDA’s organic food production regulations that only require a three- to four-month application interval. Second, some critics were concerned that the nine-month interval would prevent farmers from effectively utilizing their fields in climates with short growing seasons. In response to these concerns, the FDA removed the nine-month proposed interval and is deferring on an appropriate time interval until further research is performed.

These are just a few of the revisions proposed by the supplemental produce safety regulations. The Network for Public Health Law has revised our comprehensive FSMA Section 105 Primer to help public health practitioners stay abreast of the critical changes made to proposed produce regulations.

The Section 105 Primer is one in a series of FSMA Primers the Network has developed to highlight the new responsibilities, opportunities and resources required and provided by the FSMA — such as guidance documents, training, grant funding, contract opportunities, and improved situational awareness — that have implications for state and local governments.

If you have any questions regarding the FSMA or food safety in general, please contact the Network’s Eastern Region by email at Ask a Question or by phone at 410-706-5575. 

This post was developed by Mathew Swinburne, Senior Staff Attorney, the Network for Public Health Law–Eastern Region at the University of Maryland Francis King Carey School of Law.

The Network for Public Health Law provides information and technical assistance on issues related to public health. The legal information and assistance provided in this post does not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state.

Support for the Network is provided by the Robert Wood Johnson Foundation (RWJF). The views expressed in this post do not necessarily represent the views of, and should not be attributed to, RWJF.

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