What are the average glyphosate levels in baby formula?

Expert response from Dan Goldstein

Former Senior Science Fellow and Lead, Medical Sciences and Outreach, Monsanto Company

Monday, 03/08/2015 15:05

We question the validity of recently published analysis of glyphosate in infant and child formulas. However, if one assumes that the levels are valid, the high end values of around 0.1 milligrams (mg) of glyphosate per liter (0.1 ppm or 100 ppb) result in intakes far below the existing Allowable Daily Intake (ADI)- a 20 kg child, allowable intake 35 mg, would have an actual intake of 0.15 mg, or about 0.4 % of the ADI.  (Please see this response by  David Saltmiras for more information on ADI.)

Allowable daily intakes for glyphosate are set to protect infants and children, and we are confident that concentration of glyphosate residues in infant formulas -- if they can be detected at all -- result in intakes well below any levels of concern.

How can we say this?  To begin with, infants and children are included by design in our pesticide regulatory system, and the EPA takes all ages into account when determining ADIs and when setting allowable residue levels in food, with special attention to children when indicated.  In fact for soybean, infants are quite precisely front and center- infants on a 100% soy formula diet have the highest intake of soy protein (adjusted for body weight) of any dietary category.  Allowable daily intakes are set on the basis of body weight (intake per kilogram of body weight), account for the relatively higher calorie intake (per unit of body weight) in infants, and are appropriate for all ages.

Additionally, based on our understanding of glyphosate residues in soybeans and milk, we do not believe that the reported detections of glyphosate in infant and child formulas are valid.  We know what happens to glyphosate residues as raw soybeans are made into the various soy ingredients we call “processed fractions”.  Soy infant formulas contain partially hydrolyzed (broken down or “digested”) soy protein and may also contain soybean oil.  A processing study conducted with samples of field-grown soybeans (treated at an exaggerated rate for this study to better define potential residue reductions, and having glyphosate residues in raw soybean slightly above the maximum allowable residue level of 20 mg/kg) shows that soy protein isolate contains 500 fold less glyphosate than raw soybean and that oil has no detectable glyphosate.  We also know that water used for infant formula production is highly purified prior to use.

Infant formula typically contains about 20 grams protein per liter. Given the 500-fold reduction in residue levels (compared to unprocessed soybean), soy formula would contain at most 0.0008 mg of glyphosate per liter, assuming the unprocessed soybeans contained glyphosate at the maximum allowable level of 20 mg/kg.  A 5 kg (11 lb) infant can safely consume an allowable daily intake of 8.75 milligrams of glyphosate and will typically consume less than a liter of formula, with an expected worst-case glyphosate intake that is 10,000 times LESS than the allowable daily intake.  As far as cow’s milk-based formulas, glyphosate residues are not generally detectable even in the milk of cows on feed with maximum allowable glyphosate (WHO-JMPR 2005),.  While these are only approximate examples, we can be highly confident that glyphosate in infant formula presents no significant hazard to infants and children.

We expect levels of glyphosate in prepared infant formula to be below the concentration that can be reliably detected and quantified with validated analytical methods using technologies recommended globally by regulatory agencies.  While glyphosate can be detected and quantified at levels down to 0.01 – 0.1 ug/L in a simple matrix like water, infant formula and milk are more complex and are therefore limited to ranges between 1-10 ug/L at the low end.    Although such assays are not sensitive enough to give us a precise concentration, as glyphosate levels are expected to be below the detection limit, they can clearly establish that any glyphosate in infant formula or milk is well below the acceptable intake.  Investment in more sensitive assay systems and routine monitoring is not justified when dietary intake is clearly well below established safety-based limits.

Parents should discuss infant and child feeding options with their pediatrician, family physician, or other care providers- including breast feeding (generally preferred in infants) and the use of commercially prepared formulas.  Pesticide residues, if they can be detected at all, are well below levels of concern in commercial infant and child formulas and should not be the basis for feeding choices.  Other factors will determine the best choice of formula for a particular infant or child.   

Expert response from Dan Goldstein

Former Senior Science Fellow and Lead, Medical Sciences and Outreach, Monsanto Company

Monday, 03/08/2015 15:05

We question the validity of recently published analysis of glyphosate in infant and child formulas. However, if one assumes that the levels are valid, the high end values of around 0.1 milligrams (mg) of glyphosate per liter (0.1 ppm or 100 ppb) result in intakes far below the existing Allowable Daily Intake (ADI)- a 20 kg child, allowable intake 35 mg, would have an actual intake of 0.15 mg, or about 0.4 % of the ADI.  (Please see this response by  David Saltmiras for more information on ADI.)

Allowable daily intakes for glyphosate are set to protect infants and children, and we are confident that concentration of glyphosate residues in infant formulas -- if they can be detected at all -- result in intakes well below any levels of concern.

How can we say this?  To begin with, infants and children are included by design in our pesticide regulatory system, and the EPA takes all ages into account when determining ADIs and when setting allowable residue levels in food, with special attention to children when indicated.  In fact for soybean, infants are quite precisely front and center- infants on a 100% soy formula diet have the highest intake of soy protein (adjusted for body weight) of any dietary category.  Allowable daily intakes are set on the basis of body weight (intake per kilogram of body weight), account for the relatively higher calorie intake (per unit of body weight) in infants, and are appropriate for all ages.

Additionally, based on our understanding of glyphosate residues in soybeans and milk, we do not believe that the reported detections of glyphosate in infant and child formulas are valid.  We know what happens to glyphosate residues as raw soybeans are made into the various soy ingredients we call “processed fractions”.  Soy infant formulas contain partially hydrolyzed (broken down or “digested”) soy protein and may also contain soybean oil.  A processing study conducted with samples of field-grown soybeans (treated at an exaggerated rate for this study to better define potential residue reductions, and having glyphosate residues in raw soybean slightly above the maximum allowable residue level of 20 mg/kg) shows that soy protein isolate contains 500 fold less glyphosate than raw soybean and that oil has no detectable glyphosate.  We also know that water used for infant formula production is highly purified prior to use.

Infant formula typically contains about 20 grams protein per liter. Given the 500-fold reduction in residue levels (compared to unprocessed soybean), soy formula would contain at most 0.0008 mg of glyphosate per liter, assuming the unprocessed soybeans contained glyphosate at the maximum allowable level of 20 mg/kg.  A 5 kg (11 lb) infant can safely consume an allowable daily intake of 8.75 milligrams of glyphosate and will typically consume less than a liter of formula, with an expected worst-case glyphosate intake that is 10,000 times LESS than the allowable daily intake.  As far as cow’s milk-based formulas, glyphosate residues are not generally detectable even in the milk of cows on feed with maximum allowable glyphosate (WHO-JMPR 2005),.  While these are only approximate examples, we can be highly confident that glyphosate in infant formula presents no significant hazard to infants and children.

We expect levels of glyphosate in prepared infant formula to be below the concentration that can be reliably detected and quantified with validated analytical methods using technologies recommended globally by regulatory agencies.  While glyphosate can be detected and quantified at levels down to 0.01 – 0.1 ug/L in a simple matrix like water, infant formula and milk are more complex and are therefore limited to ranges between 1-10 ug/L at the low end.    Although such assays are not sensitive enough to give us a precise concentration, as glyphosate levels are expected to be below the detection limit, they can clearly establish that any glyphosate in infant formula or milk is well below the acceptable intake.  Investment in more sensitive assay systems and routine monitoring is not justified when dietary intake is clearly well below established safety-based limits.

Parents should discuss infant and child feeding options with their pediatrician, family physician, or other care providers- including breast feeding (generally preferred in infants) and the use of commercially prepared formulas.  Pesticide residues, if they can be detected at all, are well below levels of concern in commercial infant and child formulas and should not be the basis for feeding choices.  Other factors will determine the best choice of formula for a particular infant or child.