On November 2, 2015 the U.S. Food and Drug Administration (FDA) announced that the food safety rule governing the safe growing, harvesting, packing, and holding of produce — as well as rules governing foreign suppliers and third party accreditation – was submitted to the Federal Register for final publication. FDA recently issued final rules governing food processing facilities, and the publication of the Produce Rule will bring farmers another step closer to new food safety standards that will soon go into effect.

It will likely take several more days for the final rules to be available for public viewing, but FDA’s announcement this week tacitly acknowledges that FDA is, in effect, meeting its court-ordered deadline to finalize these rules by October 31, 2015. Once the final Produce Rule is published, it will be at least two years before many farms are expected to be in compliance with the new requirements.

As the final food safety rules are published, NSAC will undertake a thorough analysis of the final rules and provide information and materials to help explain them. NSAC recently issued a three-part analysis of the Preventive Controls Rule, which may apply to some farms as well, and which you can access here.

Once the Produce Rule is published, we will be taking a close look at the outcome of several key issues.

Agricultural Water

This has been one of the most contentious issues during the FSMA rulemaking process, as the Produce Rule sets both a microbial water quality standard and required testing frequencies for water used during growing, harvesting, packing, or holding produce if the water is likely to come into contact with the edible portions of the crop or food-contact surfaces.

In both the proposed and supplemental rules, FDA based the standard for agricultural water on EPA’s recreational water quality standard, which many in agriculture, including NSAC, saw as an ill-fitting standard, as it is based not on the hazards posed by consumption of produce, but on the hazards posed by an individual ingesting water while swimming or boating. It remains to be seen whether FDA made any further changes to the standard itself in the final rule.

In the supplemental proposal, FDA provided some flexibility in working with this ill-fitting standard by allowing farmers to still use surface water that exceeds the microbial water quality standard as long as sufficient time passes between irrigation and harvest to account for microbial die-off that occurs naturally from exposure to the elements (e.g. sun, wind). FDA also reduced the overall frequency of testing, but introduced a complicated new framework for water testing that many – including NSAC – argued was overly prescriptive and lacking in risk-based justification. We will be analyzing the rule closely to see what final adjustments FDA made to the agricultural water standard based on public feedback.

Biological Soil Amendments of Animal Origin

Another hot issue during the rulemaking process was how much time must pass between the application of a soil amendment of animal origin (that is, raw or composted manure) and harvest.

Farmers use soil amendments such as manure and compost to improve soil fertility and soil quality, and to enhance populations of beneficial micrororganisms in the soil. They have also been identified as potential vectors for pathogens that may contaminate produce. As a result, the FSMA rules required farmers wait a specific interval between the application of raw or composted manure.

However, the application intervals proposed in the initial draft rules would have severely disrupted the organic industry – by requiring a longer wait period than required under the National Organic Program – and were not sufficiently supported by the available science. This resulted in major changes in the supplemental rules, which saw the application interval for composted manure aligned with the National Organic Program, and in which FDA outlined a strategy to conduct research and a risk assessment to fully understand the risks posed by raw manure, and then use that research and risk assessment to propose a standard at a later date.

In so doing, FDA proposed to defer the application interval for raw manure until such a time as one could be proposed based on risk and science. We will be reviewing the final rule to see what changes were made to this approach, and whether FDA will establish an interim interval governing the application of raw manure until the new standard is developed, proposed for public comment, and finalized.

Additional Issues

We will also be reviewing the rule to ensure that the necessary modifications were made to the processes related to the withdrawal and reinstatement of a qualified exemption; standards directed toward wild and domesticated animals and their consequences for on-farm conservation; as well as other issues related to definitions and recordkeeping requirements — paying close attention to the overlap between the rules and how that might impact farms that are covered under both the Produce and Preventive Controls Rule.

For a refresher on other key issues to look out for in the Produce Rule, visit our website.

You can also read our recent blog posts for more on FSMA implementation and appropriations issues.