Biological Soil Amendments of Animal Origin Conference

Partnership with FDA brings national food safety discussion to Iowa

group touring the composting facilityRelevance

(Why is this issue important? Include research, statistics, and trends to support importance of issue.)

Fresh produce production and consumption has seen dramatic increases worldwide over the last 20 years. Fruits and vegetables are essential components of a healthy diet. The World Health Organization (WHO) recommends an intake of five to eight portions (400–600 g) daily of fruits and vegetables to reduce the risk of cardiovascular disease, cancer, poor cognitive performance, and other diet-related diseases, as well as for the prevention of micronutrient deficiencies (Rodriguez-Casado, 2014). The Centers for Disease Control and Prevention (CDC) estimates that each year roughly 1 in 6 Americans (or 48 million people) get sick from something they ate (foodborne disease) (CDC, 2017). Fruits, vegetables, and nuts are among the most common sources of outbreaks and illnesses in the U.S. In 2015, there were 902 foodborne disease outbreaks, resulting in 15,202 illnesses, 950 hospitalizations, 15 deaths, and 20 food product recalls (CDC, 2015). Seeded vegetables (e.g., cucumbers or tomatoes, 1,121 illnesses) caused the most outbreak-associated illnesses, followed by pork (924), and vegetable row crops (e.g., leafy vegetables, 383). There were 40 total outbreaks associated with produce and nuts in 2015, representing 21% of total outbreaks associated with food, and 1939 total illnesses associated with produce and nuts (44% of the total foodborne illnesses), see Fig. 1.  The Economic Research Service of USDA estimated in 2015 that every year foodborne illnesses associated with the top 15 harmful bacteria cost $15.5 billion in economic burden. Escherichia coli illness costs $299 million and Salmonella costs $3.7 million in 2015 as a result of physician visits, hospitalizations, post-hospital recovery, and death (USDA ERS, 2015)

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, by President Obama. It is the most sweeping reform of the United States’ food safety laws in over 70 years.  The overall objective of FSMA is to focus on preventing foodborne illnesses.  There are seven primary rules included within FSMA:

  • Produce Safety Rule which includes Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
  • Preventive Controls for Human Food
  • Preventive Controls for Animal Food
  • Foreign Supplier Verification Programs
  • Accreditation of Third-Party Auditors/Certification Bodies
  • Sanitary Transportation of Human and Animal Food
  • Prevention of Intentional Contamination/Adulteration

The FSMA Produce Safety Rule aims to reduce the risk of foodborne illnesses by asking produce farmers to document the steps they are taking to keep their produce free of harmful human pathogens. The new rule moves to a risk assessment prevention based model that is new to many farmers. 

The proposed Produce Safety Rule (78 FR 3504, January 2013) included, among other provisions, a 9-month minimum application interval for untreated Biological Soil Amendments of Animal Origin (BSAAO), such as manure.  In response to public comments, FDA withdrew this proposed interval in a supplemental proposed rule.  In the preamble to the final rule, FDA restated the decision with respect to the appropriate minimum BSAAO application interval (80 FR 74354, November 2015). The FDA acknowledged the limited body of currently available scientific evidence relating to the proposed 9-month interval and the need for additional research in this area, and described a planned risk assessment and research agenda.  The agency has currently reserved a decision on the minimum time interval or intervals to be required in the Produce Safety Rule between the application of untreated BSAAO (including raw manure) and harvest.  This applies only to covered produce (where covered means produce governed under the law and not relating to produce grown under plastic or glass) and certain application methods (21 CFR §112.56).  The BSAAO risk assessment is intended to inform policy decisions regarding the FDA’s Produce Safety Rule (Subpart F), (80 FR 74353, November 2016).

FDA published a FRN (data call) in 2016 requesting scientific data and information that would assist the agency in its plan to develop a risk assessment for produce grown in fields or other growing areas amended with untreated BSAAO.  The risk assessment will evaluate the risk of human illness associated with consumption of produce grown in fields or other growing areas amended with untreated BSAAO that are potentially contaminated with enteric pathogens such as E. coli O157:H7 or Salmonella. It will also evaluate the impact of key interventions, including use of a time interval (or intervals) between application of the soil amendment and crop harvest, on the predicted risk. 

FDA has published various fact sheets and guides, as well as a comprehensive compliance and implementation guidance that is designed to foster constituent compliance to the provisions in the Produce Safety Rule.  However, much remains unknown, unanswered, and uncertain as farmers work to comply with the FSMA Produce Safety Rule, Subpart F.


(Outputs - Identify activities, # of clients reached, publications, services, workshops, etc. used to address the issue.)

The FDA Produce Safety Network collaborated with the NCR FSMA Center and Iowa State University Extension and Outreach to develop a 1.5 day conference and tour in Iowa to discuss biological soil amendments of animal origin.  The conference, primarily targeted towards educators, regulators, and industry, was intended to help those who work with regulated growers understand how to comply with the current requirements.  The FDA staff also provided updates on the status of the BSAAO Risk Assessment and associated research, and they discussed what the results mean for the possible future of Subpart F provisions for the use of untreated BSAAO on covered farms.  Fifty people from around the country attended the event in September 2019.

Dr. David IngramDr. David Ingram, FDA Division of Produce Safety, spent much of the first morning discussing the draft guidance and current status of BSAAO risk assessment activities through the FDA, and he provided insight to the FDA’s current thinking on BSAAOs.  Dr. Ingram particularly focused on BSAAO treatment processes (such as composting but including other processes), how the rule applies to the various degrees of composting, and expected degree of control to meet standards of 112.55(a) and 112.55(b).  Furthermore, he went on to provide example statements of processing to meet record keeping requirements under 112.60 when purchasing treated BSAAOs which provided further clarification from previously released draft guidance.

Dr. Amanda Deering and Scott Monroe from the Purdue University provided further insight into pathogen survivability on produce.  Kristin Esch from the Michigan Department of Agriculture and Rural Development discussed the interaction of state level rules with the FSMA Produce Safety Rule and how Michigan navigates intertwined rules.

The afternoon of day 1 focused on practical implementation of the FSMA Produce Safety Rule, Subpart F (BSAAO).  Three invited speakers provided insight on BSAAO treatment processes and use from an industry point of view.  Jacob Fox of Closed Loop Systems discussed vermicomposting.  John Rosenow, Cowsmo Compost, discussed manufacturing compost from dairy manure.  Lloyd Schrock, Food Safety Educator working with Amish and Mennonite farmers across the country, discussed the challenges of manufacturing compost and using it on Plain farmer produce farms providing clarification on why they (Plain farmer Food Safety Educators) promote direct use of manure on fields rather than compost.

Day 1 concluded with small group discussions of practical scenarios.  These scenarios challenged participants to apply the rule in complicated situations commonly found on farms.

On day two, participants traveled to the Iowa State University composting facility in Ames.  The university composting facility is a working composting facility that uses food scraps from ISU Dining services, waste materials from the Horticulture Research Station, and dairy manure and bedding from the ISU Dairy.  Steve Jonas, manager of the compost facility, discussed his process and the equipment he uses.  He highlighted how his facility and equipment resembles other typical compost facilities and how it differs.  He further highlighted the difficulty of maintaining paperwork to meet FSMA requirement and the challenges all composters deal with of cleaning equipment when going from fresh manure to finished compost.



Identify specific changes, how outcomes were measured.)

A post-conference evaluation was distributed to participants using the online software Qualtrics.  Participants were asked to rate their knowledge for each session on a 3pt scale (Low, Med, and High) for both before the conference and after the conference.  Over all sessions, participants showed a significant (1 sided t-test, unequal variance, P<0.05) increase in knowledge gain.  However, one session stood out above the rest, vermicomposting.  Participants showed a larger gain in knowledge Pre/Post in this session than any other session. 

Following the conference, Cal Jamerson from Kansas State University Research and Extension, updated his BSAAO factsheet based on information he learned at the event.  This factsheet is commonly shared by educators across the North Central Region with farmers.


On the bus ride returning from the compost facility, a large group discussion determined that composting standards may not be equally applied to compost made on the produce farm and compost made by a third party which is then purchased by the produce farm.  A farm making their own compost could reasonably be required by an inspector to follow best practices and clean and sanitize equipment before handling finished compost.  However, a compost manufacturer, who cannot be inspected, could manufacture compost that meets FSMA requirements (time, temperature, and turnings with documentation) while never sanitizing equipment.


Farms that are buying compost only need to have a certificate of compliance from the compost manufacturer indicating that appropriate time, temperature, and turnings were met.  While produce farms that are making their own compost must maintain these same records (time, temperature, and turnings), the processes and procedure that they use can be reviewed during an inspection such that a farm making their own compost may be expected to clean and sanitize the equipment being used to make the compost more frequently than a 3rd party manufacturer.  Compost manufactured by third parties will not necessarily be held to the same standards as compost made directly on the farm.  This discussion was perfectly demonstrated on the tour and is why the Plain Farmer Food Safety Educators do not advocate for composting.  The equipment at the compost facility is never cleaned and sanitized.  Best practice with the row turner is to work from nearly finished compost to fresh compost followed by cleaning and sanitizing before starting the process over.  This is an arduous task that would add significant labor to the process.  Furthermore, the equipment used to make the compost piles is the same equipment used to remove the finished product and place into trucks.  Again, best practice is to wash and sanitize the equipment before handling finished compost but this is not feasible.  Cleaning and sanitizing processes at the tour facility would require hiring additional staff. 

Dr. David Ingram indicated that the FDA needs to provide further guidance on BSAAOs and that clarifying questions still remain.

Several participants indicated that the sample scenarios were overly complex with no clear answer.  This issue gets at one of the core challenges yet major benefits of how the FSMA Produce Safety Rule is written.  Farming is carried out differently on each farm, and the vagueness of the rule allows for farmers to use a wide array of practices.  The NCR FSMA Center must continue to work with educators and regulators in the region to understand that the rule is not prescriptive and that there will often be unclear answers to situations they encounter in the field.  One goal of the national program is to apply the rule consistently across the country (and world).  In situations that are gray (not clearly black and white), the Center can help facilitate those discussions but is not the authority to establish precedent. 

The conference was targeted to the North Central Region states.  However, the conference included participants and FDA representatives from other regions.  Theresa Klaman, FDA Produce Safety Network, shared an interesting comment from one of her colleagues.  The colleague noted the North Central Region has a lot of camaraderie across the region.  Collaborators work well together across state lines and set an example of how many organizations (State and Federal) across a region can work together to achieve a unified goal. 


Impact Statement

(Why is this important to the public? Be specific and use everyday language that makes sense to the public. The impact of your works answers the question "What is the payoff?")

The NCR FSMA Center supports the infrastructure of the national food safety program by communicating and coordinating information within the North Central Region (NCR) related to the Food Safety Modernization Act’s (FSMA) Produce Safety Rule and Preventive Control Rules so there is consistency in how the rule is applied on farms across the region.  The BSAAO Conference targeted educators and regulators within the region and focused on a challenging component of the Produce Safety Rule.  By diving into one component of the rule with the educators who teach and help farmers comply with the rule, the inspectors who regulate the industry, and the FDA which writes and interprets the rule, the NCR FSMA Center can achieve the goal of consistency across the region.  Consistency is important because some farms are operating in multiple states and could be inspected by multiple entities or, farmers trained in one state can move and start a farm elsewhere.  By having consistency across state lines, farmers can be assured that an inspection from one entity will be equivalent in a neighboring state. 

The FDA staff heard from educators and regulators and saw practices in place that clearly indicate there is need for more guidance.  They also heard examples of places where the rule may not be applied uniformly.  Events where FDA experts have the opportunity to see practical applications of FSMA and hear from those who directly interact with farmers provide insight to help develop new guidance from the agency.  Events like these are vital as stakeholders work to implement a national food safety program. 

Iowa State University had a unique opportunity to host a national event at their facilities in partnership with the FDA. This event, in conjunction with another tour with FDA guests this past summer, has helped garner recognition from partners in Washington, DC.  The staffing support, quality facilities, and location in the Central US has made Des Moines a desirable location for the FDA to do more national trainings here.  These opportunities bring outside money, prestige, and highlight “Iowa nice” for the nation to see.