GRAZING ANIMALS, WORKING ANIMALS AND ANIMAL INTRUSTION

PSR.23 If livestock are allowed to graze amongst nut or fruit trees, is it required to remove livestock from the orchard prior to harvest? If so, how many days in advance?

FDA continues to believe that an adequate waiting period between grazing and harvest is an important consideration when, under the circumstances, there is a reasonable probability that grazing animals will contaminate covered produce. As discussed in the 2013 proposed rule and our Qualitative Assessment of Risk, domesticated animals can be a source of human pathogens. Some human pathogens of public health concern (e.g., E. coli O157:H7) that have been associated with produce-related foodborne outbreaks can be transmitted from animals to people. Moreover, domesticated animals, due to their proximity and interaction with humans, are generally more likely to harbor zoonotic pathogens than are wild animals. The likelihood of contaminating produce with human pathogens from excreta from grazing animals is determined by numerous factors, including, but not limited to, the species of the animal and its association with human or domesticated animal activity or waste, the number of animals per unit area of land, agro-ecological conditions, the type of commodity and the time between animal grazing in fields and the harvest of produce.

However, currently available science does not allow us to identify a specific minimum time period between grazing and harvesting that is generally applicable across various commodities and farming practices. Rather, the appropriate minimum time period between grazing and harvesting would need to be determined based on the specific factors applicable to the conditions and practices associated with growing and harvesting the commodity. However, we encourage covered farms to voluntarily consider applying such waiting periods, as appropriate for the farm’s commodities and operations.

Under 21 CFR 112.83, we are requiring that you take the same steps if, under the circumstances there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate covered produce (21 CFR 112.83(a)). In such cases, you must assess the relevant areas used for a covered activity for evidence of potential contamination of covered produce as needed during the growing season (based on your covered produce; your practices and conditions; and your observations and experience) (21 CFR 112.83(b)(1)). If you find evidence of potential contamination during that assessment (such as observation of significant quantities of animals, significant amounts of animal excreta, or significant crop destruction), you must evaluate whether the covered produce can be harvested in accordance with the requirements of 21 CFR 112.112, and you must take measures reasonably necessary during growing to assist you later during harvest when under 21 CFR 112.112 you must identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard (21 CFR 112.83(b)(2)).

Assessing the growing areas as needed during the growing season will enable you to identify instances when covered produce cannot be harvested for safe consumption, such as produce that was directly exposed to animal excreta or that may be cross-contaminated during harvest (e.g., contamination of covered produce by contact with a food-contact surface that contacted animal excreta). Depending on the quantity of animals, extent of animal excreta, or extent of crop destruction, the affected growing areas may be localized (for example, a specific area of the field where you allowed grazing) or more widespread. We expect that, in cases of grazing and working animals, in particular, it is more likely that affected areas will be localized because grazing or working animals are expected to be present intermittently and in known areas of the field. Once you identify produce, or an area of produce, that cannot be harvested in accordance with 21 CFR 112.112, 21 CFR 112.83(b)(2) requires you to take measures reasonably necessary during growing to assist you later during harvest in complying with the requirements of 21 CFR 112.112. For example, if you have identified an area with significant animal excreta that is likely to cross-contaminate any covered produce harvested from that area such that the area may not be harvested, you could mark that area in a manner that will ensure it is not harvested, even if weather events or other occurrences remove the animal excreta so it is not visible later during harvest. For example, you might mark such an area by placing flags outlining the affected area. This provides additional protection in the event that the evidence of animal intrusion or other animal activity is no longer visible by the time of harvest, such as if a significant rain event washes away fecal deposits.

FDA recognizes the longstanding co-location of animals and plant food production in agriculture. This rule does not prohibit the use of grazing or working animals on covered farms.

SUBPART K – Growing, Harvesting, Packing, and Holding Activities

Growing, Harvesting, Packing, or Holding both Covered and Excluded Produce

PSR.24 What are the requirements for packing potatoes and parsnips using the same packinghouse equipment?

Parsnip is a covered commodity under the Produce Safety Rule (see 21 CFR 112.1(b)(1), listing parsnips as an example of covered produce). On the other hand, potatoes are not a covered commodity under the Produce Safety Rule (see 21 CFR 112.2(a)(1), listing potatoes as rarely consumed raw). However, we do want to emphasize that potato farms, and potatoes, are still subject to all applicable requirements of the FD&C Act even though they are exempt from the Produce Safety Rule.

There are provisions in the Produce Safety Rule that would be relevant to a covered farm that produces both parsnips and potatoes. For example, when using shared equipment to grow, harvest, pack or hold both covered (e.g. parsnips) and excluded produce (e.g. potatoes) it is important for covered farms to consider 21 CFR 112.111, which requires that if the excluded produce is not grown, harvested, packed or held in accordance with the Produce Safety Rule, you must take measures as applicable, to: (a) Keep covered produce separate from excluded produce (except when covered produce and excluded produce are placed in the same container for distribution); and (b) Adequately clean and sanitize, as necessary, any food contact surfaces that contact excluded produce before using such food contact surfaces for covered activities on covered produce.

As another example, Subpart L of Part 112 contains requirements for covered farms with respect to equipment, tools, buildings, and sanitation. This includes requirements regarding adequacy of equipment, cleaning and sanitizing of equipment, and storage and maintenance of equipment (see especially 21 CFR 112.123).