By Jake Rossen
By Jesse Marx
By Michelle LeBow
By Alleen Brown
By Maggie LaMaack
By CP Staff
By Jesse Marx
When a colleague in the United Kingdom faxed me "Sex-Change Chemicals in Baby Milk," a June 27, 1996 story from the London Independent, I was horrified and outraged that something many parents rely on to be wholesome nourishment for their children could be contaminated with a class of chemicals under scrutiny for possible hormonal effects. The story and subsequent others said phthalates (pronounced "THA' lates"), chemicals commonly used in plastics--especially polyvinyl chloride (PVC)--and printing inks, had been found in samples of British powdered baby formula at levels near those found to cause reproductive effects in rats.
As an activist and food safety project director at the Institute for Agriculture and Trade Policy, I had always been concerned about the pervasiveness and potential adverse effects of phthalates. But the litany of possible health effects from phthalate exposure didn't strike hard until October of last year, when I had to stop nursing my son because of medication I'm taking for a chronic illness. Suddenly, it wasn't just someone else's kids possibly at risk, but my son, too. Whether parents use formula by choice or necessity, concern over chemical exposure should not have to be a factor in selecting a formula.
What Happened in the United Kingdom?
In 1996, the Ministry of Agriculture, Food and Fisheries (MAFF) tested fifty-nine samples of fifteen different brands of powdered infant formula (cows' milk and soy) and found phthalates present in all of them. The two phthalates most commonly found were dibutyl phthalate (DBP) and di-ethylexyl phthalate (DEHP).
The levels of phthalates found in the British formula--1.2 to 10.2 milligrams/kilogram--were above the precautionary limit established by the European Commission Scientific Committee on Food. The findings were published in the media, and many parents became concerned for their children's health and welfare.
The MAFF initially refused to release the names of the formula companies, all of whom insisted their products were safe. Parents got angry. One mother who picketed the MAFF offices said, "This is not like the BSE [bovine spongiform encephalopathy, or "mad cow disease"] scare, where people can decide not to eat beef. Milk is the mainstay of our children's diets. This is the future of our children we're talking about. [The ministry] just doesn't care."
The British press made a tremendous fuss over a statement by Dr. Richard Sharpe, an eminent researcher known for his work on declining sperm counts. Dr. Sharpe said, "I look at my data showing which level of intake of one phthalate in laboratory rats can result in a ten percent decrease in sperm production, and I see that this level is ten to 100 times higher than the levels of this phthalate in baby milk powder reported by the Ministry of Agriculture." Dr. Sharpe appears not to have considered that infant formula is not a baby's sole source of phthalate exposure. He also failed to apply the precautionary principle, which states: "When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically."
How do Phthalates get into Formula?
The Ministry of Agriculture, Food and Fisheries (MAFF) speculated that general environmental contamination was a factor in the tests they conducted. Cows' milk itself may contain phthalates due to environmental contamination (as may human milk, for that matter). As global use of PVC plastic in construction and other sectors of the economy rises, so does the use of phthalates, causing a likely increase in the general levels of environmental phthalate contamination.
Phthalates may also end up in formula via packaging: numerous studies prove phthalates can and do migrate from packaging into food. A fact sheet on DEHP, used primarily to make polyvinyl chloride (PVC) plastic flexible, explains that we may be exposed to DEHP by eating "some foods packaged in plastics, especially fatty foods like milk products [emphasis mine], fish and seafood, oils . . ."
Another possibility is that plasticizers migrate from plastic tubing used during formula manufacture into the formula itself, since DEHP has been found to migrate from the plastic into foods, especially ones containing fat.
Regulatory agencies in the U.S. don't seem to be practicing the precautionary principle, which begs the question, "Why should my child be exposed to a chemical that appears to be hazardous when that exposure is unnecessary and can be eliminated?"
Ninety percent of phthalates are used in plastics; however, they are also used in printing inks, adhesives, coatings, and even pesticides. They are the most abundant chemicals made by humans in the environment, so we're all exposed (remember, even breast milk probably isn't immune from phthalate contamination). Statements such as "most people are exposed to low levels in air, water, and food" appeared on every government fact sheet I found on various phthalates. Individual levels in formula, food, air, and water may be low, but what is the sum total of that daily exposure to phthalates alone? And is there an additive or synergistic ("1+1=5") effect, when one considers the array of other chemicals to which we're exposed on a daily basis?
Looking for Answers
Since the U.K. and the U.S. have very different regulations and products, I set out to learn what's happening here. Answers were hard to come by: despite a flurry of news stories in Europe, this issue has gotten surprisingly little attention from the American media.
U.S. government officials first became aware of phthalates in infant formula in 1985, when a study found that phthalate levels were higher than desired but not at "dangerous levels," according to Elizabeth Yetley, director of the Office of Special Nutritionals (CFSAN) at the Food and Drug Administration (FDA), who was quoted in a June 3, 1996 issue of Food Chemical News. At the time of the testing in Britain, Yetley said, "Based on the best information we have now, the levels in U.S. formulas are much, much lower than the apparent levels were in the British products." The FDA hasn't taken any action on phthalates in formula because, according to Dr. Michael Bolger, head of the Contaminants division at the FDA, "it was felt that the most effective way to get at this particular issue was to identify controllable sources and to minimize or discontinue use of this kind of plasticizer."
After reading the article in Food Chemical News, I decided to contact Bolger directly. In email correspondence, he told me, "Unlike the manufacturers in the U.K. in the latter part of the 1980s, U.S. manufacturers eliminated the use of phthalates in their packaging materials because of concerns of possible carcinogenic effects observed in lab animal bioassays [tests]." However, in a subsequent phone conversation, he said he assumed manufacturers had voluntarily made process changes; it was never mandated by the agency and he hadn't followed up to see whether formula manufacturers ever actually eliminated phthalates from their packaging. He also said that any testing for phthalates now would be done voluntarily by the companies.
Following up with the Infant Formula Council, the trade association for manufacturers of baby formula, proved fruitless. Despite repeated contact attempts--two phone calls, one fax, and a letter from me to them--I never got any answers. The staff person with whom I actually spoke had no idea what phthalates were. She promised to get back to me after contacting their member companies, but so far, no information has been forthcoming.
The customer service representative at Ross Products (the division of Abbott Laboratories that makes Similac) had no idea what I was talking about; she took my name and number. No one has gotten back to me. Sandy Willett of Mead Johnson (the division of Bristol-Myers Squibb that makes Enfamil) told me that to her knowledge, there is no DEHP in their packaging materials, and that stainless steel equipment is used during the production process. She also said that, to her knowledge, Mead Johnson has not tested its infant formula products for phthalates.
I played "voice-mail tag" with Pam Aldrian of Nestle, a company with a record of customer concern over formula. She reported that Nestle's Carnation products are all tested for phthalates "on a regular basis," and the levels have been found to be below the detection limits (five to ten parts per billion). Nestle does not believe phthalates pose a "health risk" to infants, but claims to have certification from suppliers that their products, both soy and dairy, are "phthalate-free" or below detection using EPA methods.
What Could Infant Formula Makers Do Differently?
U.S. formula makers should begin by testing their products for phthalates and publicizing the results (as well as reporting them to the FDA). Currently, consumers have no simple way of accessing this information.
If phthalates are found at levels above the limits of detection, manufacturers should undergo a thorough analysis of their production processes to identify sources of phthalate contamination and take immediate action to eliminate phthalates from those sources. This process should be supervised by the FDA.
And any and all chemicals used in the packaging or processing of infant formula should be screened for their potential to cause cancer, birth defects, or disrupt the hormone system.
What Can Our Government Do?
Other nations that have already acted on phthalates provide leads for our government to follow: Denmark's environment minister, Svend Auken, has called on the Danish Environmental Protection Agency to ban the use of toxic substances, including phthalates, in toys because of concerns over health risks.
The Toronto, Ontario Public Health Department issued a report in September, 1997 to the Board of Health, calling on the Canadian Food Inspection Agency to make sure: 1) that phthalate levels in formula and fluid milk "are kept as low as technologically attainable and within relevant guidelines"; 2) that Health Canada (their federal agency on health matters) continue testing for phthalates in formula, milk, and other foods and keep levels as low as technologically possible; and 3) that Health Canada review and revise, if necessary, the "Tolerable Daily Intake" (TDI) for DEHP to make certain that it protects all age groups [emphasis mine] in the general population as well as vulnerable groups. Independent testing for phthalates to corroborate the manufacturers' findings is also critical.
What Can Consumers Do?
Breastfeed if you can. Even though phthalates are probably present in breast milk, too, the health benefits of breastfeeding are numerous and powerful.
Contact infant-formula manufacturers, and ask them to test their products, release test results to consumers, and change their production processes, if necessary. (Ask Nestle to get verification that Carnation products are indeed phthalate-free, and then put that information on their formula cans.)
The Infant Formula Council:
5775-G Peachtree-Dunwoody Road
Atlanta, GA 30342
Mead Johnson Nutritionals (Enfamil):
Customer Resource Center B-125
Evansville, IN 47721
Ross Products (Similac):
100 Abbott Park Rd.
Abbott Park, IL 60064-3500
Phone: 847-937-6100; Fax: 847-937-1511
Nestle USA, Inc. (Carnation products): 800 North Brand Blvd.
Glendale, CA 91203
Phone: 818-549-6000; fax: 818-549-6952
Write to the Food and Drug Administration and ask the agency to test particular products for phthalates, and if the chemicals are found above the limits of detection, mandate that manufacturers eliminate the production source of phthalates. Any additional exposure above "background levels" is too much, particularly when it can be prevented. Send correspondence to:
Dr. Michael Bolger
Food and Drug Administration
Center for Food Safety and Applied Nutrition Office of Special Nutritionals (HFS-450)
200 C Street, S.W.
Washington, D.C. 20204.
Reduce or eliminate your use of PVC plastic. PVC alone accounts for ninety-five percent of the DEHP used. Avoid items labeled "vinyl" or that are stamped with the plastics code #3. If in doubt, ask the merchant if it's PVC. Not buying or using PVC is one way we can all help reduce the overall environmental levels of DEHP.
Jackie Hunt Christensen is the Food Safety Project Director at the Institute for Agriculture and Trade Policy in Minneapolis. Her November 1997Minnesota Parent story, "Toxic Toys," exposed the dangers of PVC in children's toys and teethers. Jackie and her husband live in Minneapolis and have two sons.