Federal regulators set a safety threshold Friday for the industrial
chemical melamine that is greater than the amount of contamination
found so far in U.S.-made infant formula.
Food and Drug
Administration officials set a threshold of 1 part per million of
melamine in formula, provided a related chemical isn't present. They
insisted the formulas are safe.
The setting of the standard
comes days after The Associated Press reported that FDA tests had found
traces of melamine in the infant formula of one major U.S. manufacturer
and cyanuric acid, a chemical relative, in the formula of a second
major maker. The contaminated samples, which both measured at levels
below the new standard, had been analyzed several weeks ago.
The FDA had stated in early October that it was unable to set a safety contamination level for melamine in infant formula.
Though
Dr. Stephen Sundlof, FDA's director of food safety, said Friday that
there had been no new scientific studies since October that would give
regulators more safety data, he said the agency was confident in
setting the 1 part per million level for either of the chemicals alone.
He emphasized that neither of the two tainted samples had both
contaminants.
He had no ready explanation for why the level wasn't set earlier.
Sundlof
said the lack of dual contamination was key because studies so far show
dangerous health effects only when both chemicals are present.
The agency still will not set a safety level for melamine if cyanuric acid is also present, he said.
Both
the new safety level and the amount of the chemical found in U.S.-made
infant formula are far below the amounts of melamine added to infant
formula in China that have been blamed for killing at least three
babies and making thousands ill.
"The levels were so low
... that they do not cause a health risk to infants," Sundlof said.
"Parents using infant formula should continue using U.S.-manufactured
infant formula. Switching away from one of these infant formulas to
alternate diets or homemade formulas could result in infants not
receiving the complete nutrition required for proper growth and
development."
Reacting to news of the contaminated
formulas, members of Congress, a national consumer group and the
Illinois attorney general have demanded a national recall, something
the FDA said made no sense because it had no evidence suggesting that
the formula would be dangerous for babies at the levels of
contamination found.
After saying it made an error in its
data, the FDA on Wednesday produced these results: Nestle's Good Start
Supreme Infant Formula with Iron had two positive tests for melamine on
one sample; Mead Johnson's Infant Formula Powder, Enfamil LIPIL with
Iron had three positive tests on one sample for cyanuric acid.
Separately,
a third major formula maker, Abbott Laboratories, told the AP that
in-house tests had detected trace levels of melamine in its infant
formula.
Those three formula makers manufacture more than 90 percent of all infant formula produced in the United States.
The FDA said it had analyzed 74 samples and was continuing to examine 13 more.
The
agency had left the impression of a zero tolerance on Oct. 3 when it
stated: "FDA is currently unable to establish any level of melamine and
melamine-related compounds in infant formula that does not raise public
health concerns."
The FDA and other experts said the
melamine contamination in U.S.-made formula had occurred during the
manufacturing process, rather than intentionally. The U.S. government
quietly began testing domestically produced infant formula in
September, soon after problems with melamine-spiked formula surfaced in
China.
Melamine can legally be used in some food packaging,
and can rub off into food from there. It's also part of a cleaning
solution used on some food processing equipment.
There is a
gap between the concentration that the FDA detected in formula and the
agency's estimate of how much melamine could contaminate food from the
manufacturing process. The expected contamination from processing -- 15
parts per billion -- is about one-tenth the amount that the agency has
detected in infant formula. FDA officials have not responded to
questions from the AP this week about how that gap might be explained.
The agency said it is continuing research on animals to see the effects of ingesting both melamine and cyanuric acid.