Confined Production Processes for Non-Food Corn - Seed Science ...

take place, we suggest that in practice management shouldtake all the appropriate human factors into account.Records for critical tasks should document who has performedactions so that responsibility in the chain of material flowsis known so that management can apply the appropriaterewards and punishments for correctly or incorrectlycompleted actions; but more importantly, managementshould be involved before actions take place to ensurethat the right person is performing the task at a timewhen that person is ready for the task. Readiness includesnot only training and capabilities but also the properemotional state to focus on the action.This report focuses on processes associated with a fieldthat is the source of outflows of pollen, grain, or plantmaterial. This is a necessary first exploration forBIGMAP, in order to further develop the nature ofexposure associated with various categories of fields thatreceive these outflows. In the future, BIGMAP researchershope to develop models that quantify risks associated withoutflows to specific kinds of fields, including seed fields.There are currently no specific laws on contamination offoundation seed. Future studies will discuss different oradditional regulation concerning the unintended presenceof PMPs and PMIs in seed.DEFINITION OF CONTAMINATIONBefore discussing outflows to seed stocks, it is usefulto discuss the definition of “contamination.” Contaminationcan have narrow or broad definitions, but it carries theconnotation of negative consequences for the presenceof a certain substance. If there are no negativeconsequences for this substance, the word “presence”may be more appropriate. Where the presence is notdue to intentional acts and it is uncertain whetherthere are negative consequences, then “unintendedpresence” is a better choice.Because negative consequences are nearly always afunction of dosage or quantity, use of the descriptorcontamination for low levels may not be directly appropriate.However, subjective reaction allows negative consequenceseven in the absence of substantive damage to healthor the environment. If the substance has a bad image,presence at physically inconsequential levels my produceadverse reactions such as revulsion and avoidance,which are a real problem to the owner of the productwith the substance in it. Society’s tolerance variesdepending on the issue. For example, generally ourreaction to rat feces as food is very negative. Despitethis sensitivity, there is a tolerance for rat feces in somefoods, and the public generally accepts them withoutconcern. A broad definition of contamination as thepresence of an unwanted substance does not addressthe issues of “unwanted by whom” and “unwanted inwhat amounts.”Contamination of food is addressed under The FederalFood, Drug, and Cosmetic Act provisions on adulteration.This act provides a narrow definition of contaminationand illustrates the concept that low-level, unintendedpresence is not necessarily contamination. The FederalFood, Drug, and Cosmetic Act (Subchapter IV Food,Sec. 342, Adulterated Food) states the following:“A food shall be deemed to be adulterated … If it bearsor contains any poisonous or deleterious substancewhich may render it injurious to health; but in case thesubstance is not an added substance such food shallnot be considered adulterated under this clause if thequantity of such substance in such food does notordinarily render it injurious to health.”Use of the word contamination for the unintendedpresence of a PMP or PMI would be appropriate on theassumption that 1) a PMP or PMI would be defined as a“poisonous or deleterious substance” by the FDA, 2)the grain or seed would be considered food under thislaw, and 3) the FDA would not define a quantity tolerance.We believe that the FDA currently applies theseassumptions to PMPs and PMIs. Currently, their unintendedpresence would be contamination. FDA statutes or theinterpretation of statutes could change for some specificproducts and make the use of the word contaminationfor unintended presence inappropriate for someplant-manufactured substances. Unintended presencebelow a tolerance would not constitute adulteration orcontamination. Contamination is a value-based classificationthat has its origin in policy decisions. Policy makersmust decide whether a definition of a tolerance has thepotential to solve economic problems associated withPMPs and PMIs.