"This is not to suggest that these components are unnecessary, but simply that they are not inert, should be scrutinized. "

I am not going to say that the process to put things on the EPA GRAS list is perfect.  I am not going to say any regulatory process is perfect.  But, the statement that things are put on GRAS without being scrutinized is not accurate.  The term inert does not mean the substance is harmless under all circumstances.  Nothing is always harmless.  The term inert simply means the additive is not biologically active by itself at the rates applied in terms of killing what ever the pesticide formulation is aimed at killing.  Depending on the substance EPA has the right to ask for any studies it deems appropriate before inclusion on the GRAS list.  I have never heard of a case where they required all the studies that are applied to an active ingredient.  I have never heard of any requirement for a three generation rat study with establishment of a no effect level for instance.  They also do not in general require residue studies on consumed food products.  For things like my disodium phosphate example they did not even ask for a LD50 determination.  But, there is a process that must take place by law.  The process involves publication of a notice in the Federal Register that the substance is being considered and asking for public comments after the EPA has done a tech review and decided the substance is safe.  All public comments are read and considered.  If some comment suggests a risk EPA must somehow address that risk.  They may address it by simply saying disodium phosphate is on the FDA GRAS list for food additives and the FDA data shows it to be safe.  In the case of some poly oxy ethylene surfactant they might point to widely used similar products found in shampoos as providing adequate evidence of safety.  They might ask the applicant to provide some experimental data to show safety.  Perhaps run some mutagenicity tests for example.  Or eye or skin irritation studies to insure applicators are safe.  But, they do not require the hundreds of millions of dollars in studies required to register an active ingredient.  If they did there would be nothing on the GRAS list as none of these small uses generates the dollars to justify such studies not is there the risk to the applicators, to the environment nor to consumers that an active ingredient poses.  Could something get included that was later found to cause problems or health issues to applicators, the environment or consumers the EPS has the right to pull the GRAS listing.  Sooner or later this is going to happen.  Perhaps it will happen with the silicone surfactants.  But, I doubt if it will happen to the silicon surfactants simply because in combination with some specific virus it may harm honey bees under field conditions even if we find that is the case.  More likely they would apply a label restriction concerning honey bee risks.  Now, show that it harms all pollinators and that is a different story and could get it in trouble.  But also realize that they are going to look at how bad a farmer needs the product and how widely it is used.  That need and usage also have a weight in the decision equation.  Risk must be balanced with benefit.  That is why we allow cars to be manufactured even thou 30,000 people get killed in cars in the US per year.  By contrast the US human death rate per year from Ag pesticides or additives is probably zero except for suicides or very rare off label applications like happened in watermelons 30 years ago by one grower.  I do not remember if anyone actually died from that watermelon case.  I think not.

There is an under lying implication that the scientists at the regulatory agencies are little besides rubber stamps.  Having worked with these folks I can tell you they have some really bright and dedicated scientists who do not take their jobs lightly.  One of our brightest scientists left us to join the EPA back in the mid 1970s.  He, by the way, was never allowed to work on any of our registration studies to avoid any conflict of interest.  Actually, the only really safe answer they can ever give is to say no to some proposal.  If they say no it is not marketed and they have no risk of it coming back and biting their behinds years down the road.  They really like to say no.  Or stall on a decision by asking for more data.  Were I in their shoes I would do the same.

Dick

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