1. The Health Care Without Harm (HCWH) indicates in multiple places in the report that if exposure to a substance exceeds the levels set by regulators, individuals then face a risk.

WRONG. With regard to phthalates, exceeding the exposure levels set by the government is not at all the same as encountering a risk. For example, at the FDA, regulators establish those levels with a very large margin of safety. They do this by starting at a level where no effects are seen in animals after a lifetime of exposure, and then set the safety level far lower - at least 100 or even 1,000 times lower.

2. HCWH concedes that there is no reliable evidence that any harm has ever come to humans from phthalates, but says that's because they haven't been studied in humans.

WRONG. To be sure, we don't know of anyone who has purposely given large amounts of phthalates to humans to see if they could do some harm! But the government and the chemical industry do high quality health and safety testing in a scientifically accepted way - on animal models with relevant protocols. Phthalates are among the best-studied compounds in the world. Rodents are the usual model, because they are relatively inexpensive to study, but then there are some questions about whether results are relevant to humans. Phthalates also have been studied in non-human primates, which are much more similar to humans (who are also primates), and those studies have indicated that primates are far less sensitive to phthalates than are rodents. Yet even rodents do not show effects until they receive high doses.

3. HCWH implies FDA used a safety factor of only 3 in assessing possible risk from phthalates to patients in hospitals.

WRONG. FDA used a total safety factor of 100. HCWH questions whether one portion of that safety factor should have been greater than 3, but never informs the reader that the overall safety factor was 100, leaving the impression FDA used only a factor of 3.

4. HCWH says regulatory agencies concluded that reproductive effects of some phthalates in animals were found to be relevant to humans.

WRONG. There is no such "conclusion." Standard regulatory practice regarding animal data is to assume that it is relevant to humans if there are no actual human data, or insufficient evidence to disprove the relevance of the animal data. It is a default assumption, not a "conclusion" by the agencies.

5. HCWH says that regulators should look at aggregate exposure to all phthalates to determine risk.

WRONG. Why? Aggregating exposures is only valid for substances that act via additive mechanisms. For phthalates, there is no evidence to support the additive theory, and some evidence to refute it. Even HCWH's own Executive Summary says that "health effects that may be caused by exposure to the phthalates differ among the various compounds and depend on the timing and size of the dose." Not all phthalates act the same, and none have acted at all on laboratory animals unless the dose is very large. So, arguing that phthalate exposures are additive is a good scare tactic, but not good science.

6. HCWH implies that CDC data show women of childbearing age have higher than average concentrations of phthalates in them.

WRONG: The median exposure for women in the 20-40 year old age group was the same as for the general population, within the error limits of the study. HWCH is referring to the exposure levels at the 95th percentile - that is, the women at the very top of the exposure scale. The study on which HCWH relies was an initial survey of only 289 persons, of which only 96 were women of childbearing age, and only 4 or 5 were at or above the 95th percentile. This is a very thin reed on which to base any conclusions. In fact, when CDC later published results from a sample of 1029 persons - almost four times larger -- it decided not to break down the data by age group because the sample size was so small. CDC will publish further data in the fall of 2002, with age breakdowns, that will provide more conclusive information. However, even the 95th percentile levels cited by HCWH in the initial data are within government safety levels.

7. HCWH says that the upper 5% of women aged 20-40 in the sample have 75% of the level of DBP "that may begin to impair normal reproductive tract development in their baby boys."

WRONG. At the 95th percentile, women had an exposure that is 64 percent of a value that is one-thousandth of the no effect level for DBP established in animal studies. And once again, even in the worst case scenario as laid out by HCWH, the doses the women received merely cut slightly into a huge margin of safety.

8. HCWH says many nail polishes have "large quantities of DBP."

WRONG. The concentration of DBP in nail polish is typically in the 1-2 percent range. One nail-care product has a 15 percent concentration. But the real question is not how much DBP is in the nail polish - it is how much enters the body and how does that amount compare to government safety levels. The rate of absorption of phthalates through surface contact is very low. This is supported by the CDC data that show that total exposures to DBP (from nail polish and all other sources) are within safety levels.

9. HCWH says that the FDA considered only medical devices and "not the real world of population-wide exposures to multiple phthalates from multiple sources."

WRONG and very unfair. FDA conducted itself responsibly when it assessed the safety of medical devices containing phthalates. Every center at the FDA was involved in the assessment. It was looking for situations where exposure could approach or exceed a "tolerable intake." In its review, FDA recognized the uncertainty associated with extrapolating human effects from animal data, stating that "It is possible that the effects observed in animal studies could occur in humans. However, there are no human studies to date that show such effects. DEHP-containing medical devices have been used on newborn babies for many years without apparent ill effects, although studies have not been conducted that would rule out effects in humans."

10. HCWH says that pregnant women come to the hospital already significantly contaminated with phthalates, and "medical exposures add more."

WRONG. As discussed above, the CDC data show that general exposures to phthalates are within safety levels, levels that in turn incorporate large margins of safety. Additionally, HCWH's statement is likely to be misleading, causing people to think large amounts of phthalates accumulate in our bodies. Actually, they are broken down and excreted within 24 hours and do not pose a bioaccumulation concern. Moreover, to the extent that exposure to patients in hospitals comes from intravenous treatments, any phthalates that might enter the blood stream directly are not as readily metabolized and made available to the body as those that are ingested.

Related Link: ACTIVIST GROUP RECYCLES AN OLD CAMPAIGN -- Statement of the Phthalate Esters Panel On Health Care Without Harm Report -- July 10, 2002

Contact:
Marian K. Stanley
Manager, Phthalate Esters Panel (www.phthalates.org)
(703) 741-5623
E-mail: marian_stanley@americanchemistry.com