IMPORTANT: This text has been updated to reflect changes in the proposed FSMA rules as of October 2014.
Animals are a part of many agricultural systems. Domesticated animals such as livestock play a critical role in diversified farming systems, both because they or their products become food and because they cycle nutrients through the farm. Wild animals can help to manage pest populations and contribute to biodiversity. While there is still only limited scientific understanding of the role that animals play in contaminating produce and limited evidence of animals causing food safety outbreaks, a few recent outbreaks have identified animals one of the possible sources of contamination.
The Food Safety Modernization Act (FSMA) requires the Food and Drug Administration (FDA) to develop regulations aimed at improving the safety of produce. Because animals have been considered a possible source of contamination in food safety outbreaks involving produce, Congress required FDA to include standards for “animals in the growing area” when developing new regulations. In the proposed Produce Rule, FDA has developed standards directed to domesticated and wild animals.
The main goal of the proposed standards for domesticated and wild animals is to prevent the contamination of covered produce by “animal excreta” – solid or liquid animal waste. “Covered” produce refers to the produce subject to the requirements of the Produce Rule (list is available here). The three main animal populations that FDA identifies are:
Broadly, the proposed standards require a farmer to take certain preventative measures if there is a reasonable probability that animals will contaminate produce covered by the new standards. FDA does not define what it considers to be a reasonable probability, but it has indicated that it will provide further details when it publishes guidance documents accompanying the final regulations.
If there is a reasonable probability that animals will contaminate covered produce, then the proposed animal standards apply to any outside area or partially-enclosed building where growing, harvesting, holding, or packing of covered produce occurs. These proposed animal standards do not apply to those activities when they take place in a fully enclosed building (see below for other standards that apply).
If there is a reasonable probability that domesticated animals that graze in fields will contaminate covered produce, then the proposed standards require an “adequate waiting period” between grazing and harvest. The regulations do not specify a length of time that FDA considers an adequate waiting period, but the preamble to the regulations states that FDA would not expect the waiting period to exceed nine months. This is the same interval that FDA had originally proposed between the application of raw manure and harvest, but FDA has deferred its decision on the 9-month application interval until it has more science and a robust risk assessment to justify it. The nine months mentioned in the preamble should not apply until a proposed interval is finalized.
If there is a reasonable probability that working animals will contaminate covered produce, then FDA requires a farmer to take “measures” to prevent the introduction of foreseeable hazards such as animal feces. FDA does not specify what those measures are, but in the preamble to the regulations, FDA provides the example of using horse paths that are separated from produce plantings as a “measure” if a farmer works with a draft horse.
If there is a reasonable probability that covered produce will become contaminated due to animal intrusion, FDA requires farmers to monitor areas where produce is grown, harvested, held, or packed as needed during the growing season and immediately prior to harvest. If animal intrusion occurs, then the farmer must not harvest produce that is visibly contaminated by animal feces or urine. Evidence of animal intrusion includes observation of significant quantities of animals, animal feces, or crop destruction due to grazing.
These standards cover the unintentional presence of animal feces or urine; they are separate from the proposed standards on the use of manure and other soil amendments derived from animals in crop production.
Additionally, FDA proposed separate standards to control animal waste from domesticated animals to prevent that waste from contaminating produce, food-contact surfaces, or agricultural water. FDA is requiring farmers to adequately control the excreta (feces and urine) and litter of domesticated animals, and maintain a system of control of animal excreta and litter. As an example, FDA says that not locating manure piles adjacent to packing sheds in which covered produce is exposed would serve as compliance with these standards.
FDA is proposing to apply separate standards to domesticated animals in and around a fully enclosed building. To avoid contamination by domesticated animals in fully enclosed buildings, FDA is proposing that farmers:
FDA is allowing farmers to use guard or guide dogs in some areas of a fully enclosed building if contamination of produce, food-contact surfaces, or food-packing materials is unlikely to occur.
Just as important as what the proposed standards require is what they do not require.
For example, the proposed standards do not require farmers to take extreme actions, such as prohibiting the use of domesticated animals on produce farms or requiring that farmers build a fence around produce fields. FDA is also not requiring farmers to clear farm borders or destroy wildlife habitat. While FDA does not intend for the standards to result in these extreme actions, the proposed standards originally did not outright prohibit these actions.
To address this issue, FDA has included a new provision in the re-proposed regulations that specifically state that nothing in the Produce Rule requires covered farms to take measures to exclude animals from outdoor growing areas, or to destroy animal habitat, or otherwise clear farm borders around outdoor growing areas or drainages. This is a significant improvement from the original proposal and should help FDA avoid inadvertently promoting or encouraging practices that adversely affect wildlife and animal habitat, including impacts on threatened or endangered species.
FDA discussed its decision to require and not require specific actions in the preamble to the proposed regulations. Many of FDA’s decisions to require certain actions instead of others are tentative and not yet finalized, including the following issues, which were not re-addressed in the re-proposed Produce Rule:
If you have domestic animals on your farm (including livestock or working animals like dogs), FDA needs to hear from you about how these proposed rules might impact your farm operation. FDA is requesting comment on the proposed standards, on what is not required, on additional specific issues, and on information to include in additional guidance documents.
Here are some questions to guide your comments on this part of proposed Produce Rule:
Thanks to NSAC member organization Wild Farm Alliance for their assistance in developing this analysis!
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