FDA Listening Session: Answers to Stakeholder Concerns

May. 15, 2013


On April 30, stakeholders stood before a panel of government officials during a listening session to express their concerns about the Produce Rule in the Food Safety Modernization Act (FSMA). While most grower questions were answered during the session, some involving an establishment's total food sales and soil amendments required further research. Content below, from Cathy McDermott of the FDA, provides feedback to those unanswered questions: 

The question was, does the “average annual value of food sold” include food for animals, such as hay?

From the FDCA’s definition of food, (“The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article”).  This definition of food does include food, such as hay, used for animals. 

Also during the listening session the participants asked several questions about the Biological Soil Amendment (BSA) of Animal Origin proposed requirements.  Specifically, the questions involved specific scenarios in which untreated BSA could be used to such that the minimum time interval between application and harvest is zero days.  The FDA indicated that if the untreated BSA is applied in a manner that does not contact covered produce during or after application, then the minimum application interval would be zero days.  The minimum time interval for untreated manure that is applied in a manner does not contact produce during application (but could contact covered produce after application) and minimizes the potential for contact with covered produce is 9 months.  We welcome comment on these standards

Finally questions were asked about the scientific basis for the 9-month time interval between application of untreated BSAoAO and the harvest of covered produce.  Below are studies that were utilized to support the proposed requirement. 

Studies that may be referenced, suggesting a longer time frame may be appropriate, include:

-         Islam, M., J. Morgan, M.P. Doyle, et al. 2004. Persistence of Salmonella enterica Serovar Typhimurium on Lettuce and Parsely and in Soils on Which They Were Grown in Fields Treated with Contaminated Manure Composts or Irrigation Water. Foodborne Pathogens and Disease 1(1): 27-35.

-         Islam, M., M.P. Doyle, S.C. Phatak, et al. 2005. Survival of Escherichia coli 0157:H7 in soil and on carrots and onions grown in fields treated with contaminated manure composts or irrigation water. Food Microbiology 22(2005): 63-70.

-         Fukushima, H., K. Hoshina, and M. Gomyoda. 1999. Long-Term Survival of Shiga Toxin-Producing Escherichia coli O26, O111, and O157 in Bovine Feces. Applied and Environmental Microbiology 65(11): 5177–5181.

-         Gagliardi, J. V., and J. S. Karns. 2000. Leaching of Escherichia coli O157:H7 in Diverse Soils under Various Agricultural Management Practices. Applied and Environmental Microbiology 66(3): 877–883.

-         Kudva, I. T., Blanch, K., and Hovde, C. J. ‘‘Analysis of Escherichia coli O157:H7 Survival in Ovine or Bovine Manure and Manure Slurry.’’ Applied and Environmental Microbiology 64, no. 9 (1998): 3166–3174.

-         Wang, W., Zhao, and M.P. Doyle. Fate of enterohemorrhagic Escherichia coli O157:H7 in bovine feces. Journal of Applied and Environmental Microbiology 62: No. 7, 1996.