Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water

Dear Commissioner Califf: The Northwest Horticultural Council (NHC) writes today to provide comment regarding the proposed rule published in the U.S. Federal Register on July 19, 2022, by the U.S. Food and Drug Administration (FDA) in Docket No. FDA-2021-N-0471, entitled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water." The NHC is a trade association that represents growers, packers, and shippers of apples, pears, and cherries in Washington, Oregon, and Idaho. Our growers produce approximately 69 percent of the apples (supplying 78 percent of the U.S. fresh market), 88 percent of the fresh pears, and 69 percent of the fresh sweet cherries grown in the United States. Food safety has long been a priority of the Pacific Northwest tree fruit industry. Our growers and packers care about providing a safe and nutritious product to their consumers. In addition to the Food Safety Modernization Act, our growers have complied with a myriad of food safety programs for over a decade, ranging from the USDA Good Agricultural Practices program to private schemes like GlobalGAP and the Safe Quality Foods program. The NHC provided comments regarding the content of FDA's proposed rule published on December 6, 2021. We appreciate FDA's current proposal to formally establish new compliance dates that allow this rulemaking process to be completed, as well as for growers to understand how to apply the new requirements within their own operations. It is important for growers to have certainty regarding when they will be required to comply with a new agricultural water regulation. This is especially true if the final rule takes a similar approach to what was proposed, which is drastically different than the existing requirement and will create a steep learning curve for the vast majority of produce growers. In terms of the new compliance dates proposed, the NHC concurs with FDA's conclusion that it is appropriate for most growers to be required to comply with the harvest and postharvest provisions of the current rule by January 26, 2023 (with additional time for small and very small businesses). As the agency notes, FDA's proposed rule does not suggest any changes to these provisions. In addition, the requirements for harvest and postharvest water in the existing rule are very similar to what is already required in existing food safety programs, so the vast majority of the growers we represent have already applied them on-the-farm. The NHC also has no concerns with FDA's proposal related to the pre-harvest agricultural water provisions. Since the date on which FDA will publish the final rule is unknown, the NHC considers it appropriate for the agency to set a compliance date based on the effective date of the final rule. Furthermore, assuming that the final rule is similar to what was originally proposed, the NHC concurs that nine months is an appropriate time period for most growers to prepare for preliminary compliance with the new regulation. However, regardless of what compliance date the agency decides to impose, it is important for FDA to recognize that an agricultural water assessment as described in this proposed rule will be difficult for growers to undertake – especially for those who irrigate out of an open canal irrigation system. It will take time, training, and direct assistance in some cases for growers to learn how to conduct such an assessment. It will also take time for inspectors to fully grasp the multitude of different factors that affect the agricultural water assessment of each individual produce operation. Therefore, we strongly encourage FDA to commit in the preamble of the final rule to take an "educate before and while you regulate" approach to implementation of such a requirement, due to the complexities of conducting an agricultural water assessment that includes aspects of a grower's water system outside of his or her control and…

The Northwest Horticultural Council (NHC) writes today to provide comment regarding the proposed rule published in the U.S. Federal Register on December 6, 2021, by the U.S. Food and Drug Administration (FDA) in Docket No. FDA-2021-N-4071, entitled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water." The NHC is a trade association that represents growers, packers, and shippers of apples, pears, and cherries in Washington, Oregon, and Idaho. Our growers produce approximately 69 percent of the apples (supplying 78 percent of the U.S. fresh market), 88 percent of the fresh pears, and 69 percent of the fresh sweet cherries grown in the United States. Food safety has long been a priority of the Pacific Northwest tree-fruit industry. Our growers and packers care about providing a safe and nutritious product to their consumers. In addition to the Food Safety Modernization Act, our growers have complied with a myriad of food safety programs for over a decade, ranging from the USDA Good Agricultural Practices program to private schemes like GlobalGAP and the Safe Quality Foods program. We appreciate the extensive outreach that FDA staff conducted as the agency developed this proposed rule, including visits to tree fruit farms in Washington and Oregon and hosting a public meeting in Portland, Oregon. We commend FDA for shifting to a more risk-based regulatory approach that better takes into account the multitude of different factors that impact whether potential hazards in agricultural water pose a risk to consumers through particular commodities and growing conditions. We also support the flexibility this rule provides to allow for new science-based information to be incorporated into a grower's food safety plan. We believe this will result in a regulation that is more protective of consumer health, while allowing growers to focus their resources on the hazards that pose the most significant risk within their own operations. That being said, we have recommended changes and suggestions for implementation to make sure that this rule is both workable for growers and protective of consumer health. Our detailed comments, along with supporting documentation, are enclosed.