Final Produce Rules From Food and Drug Administration (FDA) Are Out

The much-awaited final food safety rules for produce farms—otherwise known as the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption ( officially released on 11/27/15.

The Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. Co-management of food safety, conservation, and environmental protection are addressed within the Produce Safety Rule, most notably in the sections on domesticated and wild animals, agricultural water (water quality and testing), and biological soil amendments (raw manure and stabilized compost). Other key requirements address sprouts, worker training and health and hygiene, and equipment, tools and buildings. Exemptions where the rule does not apply are explained, as well as compliance dates for different types of operations.

If you are interested reading the full version of the Produce Safety Rule(

it is good to know that the the first 700 pages contains the Preamble, which explains FDA’s thinking. The rules themselves begin after that. For those of you who just want an easily digestible fact sheet, you can find one here (


Below are some excerpts from the Preamble and the Rule:

Excerpts Relating to Co-Management in the Preamble to the Rule

In the Preamble to the rule, it states “We encourage the application of practices that can enhance food safety and that are also consistent with sustainable conservation… We continue to encourage the co-management of food safety, conservation, and environmental protection. We consider it important to take into account the environmental practice standards and policies of other relevant agencies in the context of food safety.”

The FDA states in other parts of the Preamble that

“Domesticated animals, due to their close proximity and interaction with humans, are generally more likely to harbor zoonotic pathogens than are wild animals.” Further in the Preamble they say: “We understand that when covered produce [meaning produce eaten raw], is grown in an outdoor environment, wild or feral animals are likely to have access to production fields. We reiterate that the presence of animals in a production field of covered produce, in and of itself, is not a significant food safety risk. However, wild or feral animals are known zoonotic disease reservoirs for human pathogens, and therefore their excreta may contaminate growing covered produce crops.”

Excerpts Relating to Co-management in the Produce Safety Rule

In the subpart on Domestic And Wild Animals in the rule, the Produce Safety Rule states that

“Nothing in this regulation authorizes the ‘taking’ of threatened or endangered species as that term is defined by the Endangered Species Act … in violation of the Endangered Species Act. This regulation does not require covered farms [non-exempt 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.”

The Rule requires that “…if under the circumstances there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate covered produce you must:

"(1) 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); and

(2) If significant evidence of potential contamination is found (such as observation of animals, animal excreta or crop destruction), you must evaluate whether the covered produce can be harvested … and take measures reasonably necessary during growing to assist you later during harvest when you must identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard.”

In the subpart on Growing, Harvesting, Packing And Holding Activities, the Produce Safety Rule requires that:

“You must take all measures reasonably necessary to identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard, including steps to identify and not harvest covered produce that is visibly contaminated with animal excreta. At a minimum, identifying and not harvesting covered produce that is reasonably likely to be contaminated with animal excreta or that is visibly contaminated with animal excreta requires a visual assessment of the growing area and all covered produce to be harvested, regardless of the harvest method used.”

In the subpart on Agricultural Water, the Produce Safety Rule states:

 “At the beginning of a growing season, as appropriate, but at least once annually, you must inspect all of your agricultural water systems, to the extent they are under your control (including water sources, water distribution systems, facilities, and equipment), to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce. ”

In the subpart on Biological Soil Amendments, the Rule  states:

“If the biological soil amendment of animal origin is—Untreated [such as raw manure],” then … it “must be applied-- In a manner that does not contact covered produce during application and minimizes the potential for contact with covered produce after application.”

“At this time, the FDA does not object to farmers complying with the USDA’s National Organic Program standards, which call for a 120-day interval between the application of raw manure for crops in contact with the soil and 90 days for crops not in contact with the soil.”

 by Jo Ann Baumgartner