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INFANT FORMULA SHOWS NO SIGN OF PESTICIDE CONTAMINATION IN INDUSTRY STUDY

This article was originally published in The Tan Sheet

Executive Summary

INFANT FORMULA SHOWS NO SIGN OF PESTICIDE CONTAMINATION IN INDUSTRY STUDY published in the April issue of Regulatory Toxicology and Pharmacology. Undertaken by Robert Gelardi and Mardi Mountford of the Infant Formula Council (IFC), the study examined 2,043 samples of milk-based infant formula and 1,141 samples of soy-based infant formula that were "tested over a number of years by the infant formula manufacturers and contract laboratories" for a total of 34 different pesticides. No more than 154 samples of milk-based formula and 84 soy-based formula samples were tested for a particular pesticide. In addition, the IFC also looked at over 1,000 samples of ingredient water and found no instances of contamination from 24 different pesticides. Ingredient water "comprises more than 85% of ready-to-feed formulas," the IFC noted. This testing, "using modern, sensitive analytical equipment and procedures, has revealed no detectable levels of pesticide residues in U.S. manufactured infant formula," Gelardi and Mountford concluded. IFC became involved in testing for pesticide residues following the initiation of a review of the diets of infants and children by the National Academy of Sciences' Committee on Pesticides in the Diets of Infants and Children. The NAS committee is expected to issue a report on its findings later this year. The pesticides chosen for the IFC analysis were among those identified by the NAS committee as being of the greatest concern. To test for pesticide residues, infant formula manufacturers used multiresidue chromatographic procedures that "allow the determination of a large number of residues in one analysis run," as well as single-residue methods that "target specific analytes and can be fine-tuned for a particular pesticide." Both types of methods can employ gas chromatography or high performance liquid chromatography, according to the study. Enzyme-linked immunosorbent assays also were used for pesticide residue analysis. IFC speculated that no pesticide residues were found in infant formulas mostly because of "the use of engineering controls and monitoring programs within the infant formula industry to avert contamination of the final product." Such controls are possible to establish, the authors noted, because manufacturers can reduce infant formula to its individual ingredients and evaluate each independently. Since water is by volume and mass the largest segment of ready-to-feed infant formulas, "it represents potentially the most significant source of pesticide residues." IFC added that "by carefully controlling the water supply, this potential risk can be minimized." In particular, the use of carbon filtration systems can bring the risk of infant formula contamination "to near zero," according to the study researchers. The study also noted that the "physical and chemical processes that convert agricultural commodities into infant formula ingredients have a significant effect on the fate of any potential pesticide residues." A model to "predict the survival or destruction of pesticide residues through processing" has been developed, Gelardi and Mountford said, and has provided information toward designing "appropriate monitoring and control systems where needed." The industry group concluded in the article that "infant formulas, manufactured under the regulations of the Infant Formula Act, are carefully quality controlled and are a reliable source of complete, safe nutrition to infants." The Infant Formula Act of 1986 was implemented via a December 1991 final rule that established infant formula record and record retention requirements. FDA is preparing a proposal to establish current good manufacturing practices and strengthen existing quality control procedures for infant formulas. The proposed rule is slated for release in August, according to the agency's most recent regulatory agenda. IFC met with FDA on April 5 to discuss the issue of potential pesticide contamination of infant formula. Lead levels in infant formulas also were addressed at the meeting. IFC emphasized to FDA that pesticide residues have never been found in infant formulas and showed agency officials a videotape prepared by IFC that documented consumer perceptions about pesticide residues, particularly in infant formulas, according to an FDA memorandum of the meeting. The video has been used to prepare an IFC "information statement" that assures: "Not even trace residues have been detected despite testing thousands of samples for many years. Infant formulas are carefully quality controlled and manufactured to exacting FDA and industry standards." Regarding lead contamination, IFC told the agency that it is continuing its efforts to monitor lead levels in infant formula. The group provided FDA with recent six-month industry monitoring data that showed that the majority of infant formulas tested did not contain detectable levels of lead (less than or equal to .005 parts per million), the memo says. Determining lead levels in infant formula is part of a broader FDA effort to reduce lead levels in food where controllable or avoidable sources of lead can be identified. To assist the agency, IFC said it agreed to generate industry data on lead in infant formula and provide updates on its findings on a quarterly basis. Data presented by IFC at the April 5 meeting covered January to March. As part of its lead initiative, FDA also is planning to issue specifications for lead in calcium supplements that are generally recognized as safe. A proposed rule on lead in calcium supplements is slated for issuance in December, according to the agency's recent regulatory agenda.
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