Opinion ID: 415382
Heading Depth: 1
Heading Rank: 4

Heading: the risk of cancer from uffi

Text: 23 As we have noted, the Commission incorporated the results of the Chemical Institute high-exposure rat study into its Global 79 computerized risk assessment model in order to predict the cancer risk to humans at the low levels of formaldehyde exposure associated with UFFI. Based on actual formaldehyde levels found in 1,164 homes, the Commission found that [a]ny individual living in a home with U.F. foam insulation for 9 years after installation would, according to the assessment, have an additional risk of 51 in a million of developing cancer from the formaldehyde released by the insulation. 47 Fed.Reg. at 14,372. The Franklin/Oak Ridge Lab studies predicted an additional risk of 37 in a million. 24 According to the industry, these predictions are flawed for a number of reasons. The industry argues that: (1) neither the formaldehyde levels found in the 1,164 test homes nor the Franklin/Oak Ridge Labs test results are accurate indicators of the formaldehyde levels in average UFFI homes; (2) the Commission erred in relying exclusively on the Chemical Institute rat data in its risk assessment model and ignored numerous epidemiologic studies indicating that formaldehyde is not a human carcinogen; (3) the Commission ignored the real explanation for the incidence of tumors at the high levels of formaldehyde exposure involved in the Chemical Institute study; (4) no substantial evidence supports the Commission's assumption that the effective formaldehyde dose for humans is the same as that for rats; (5) Global 79 incorporates several assumptions about formaldehyde carcinogenicity that are not supported by substantial evidence; (6) Global 79 predicts only an upper limit of risk and does not constitute substantial evidence that it is at least more likely than not that [UFFI] presents a significant risk of [cancer], Industrial Union Dept. AFL-CIO v. American Petroleum Inst., 448 U.S. 607, 653, 100 S.Ct. 2844, 2869, 65 L.Ed.2d 1010 (1980); and (7) other federal agencies have determined that formaldehyde does not pose a substantial health risk to man. We need examine only the first two contentions in detail.
25 At the outset, the industry asserts that the average formaldehyde level attributed by the Commission to UFFI homes is inaccurate and grossly exaggerates the true level. In fact, the industry contends that there is no significant difference between formaldehyde levels in UFFI homes and non-UFFI homes. 26 According to the industry, the in-home measurements, which resulted in a predicted additional risk of cancer of 51 in a million, were scientifically invalid and do not constitute substantial evidence. The industry points out that the great majority of the tests were conducted by state agencies, not Commission personnel. Measurement methodologies differed from state to state. Twenty percent of the test homes were located in Massachusetts and Minnesota, where measurement techniques of questionable accuracy were used. More important, the test homes were not randomly chosen. A large percentage of the measurements taken were in residences whose occupants had complained about UFFI-related health problems. 10 According to the industry, this tended to overstate the actual average level. Additionally, the high formaldehyde levels that were recorded in many of the complaint homes were the result of faulty installation. 11 These problems could be eliminated by a product standard. The industry concludes that the Commission should have conducted its own tests of randomly selected UFFI homes before taking the draconian step of a product ban. 27 The industry also asserts that the Franklin/Oak Ridge Labs test data do not accurately predict formaldehyde levels in actual homes. It notes that only nine panels were tested and that the results varied widely around the mean of .13 ppm. 12 The industry also argues that storage of the panels in extreme conditions invalidated the test results. 13 Additionally, the industry contends that the test did not account for the air flow and exchange that occurs in actual homes and that Oak Ridge Lab recognized that this failure could lead to errors of two- to threefold. According to the industry, even the Commission recognized that in-home measurements could not be extrapolated from the Franklin/Oak Ridge Labs data. 28 The industry bases its claim that formaldehyde levels in UFFI homes do not differ significantly from levels in non-UFFI homes on three studies. A University of Iowa study conducted by Dr. Frank found no difference in formaldehyde levels in randomly selected UFFI and non-UFFI homes. 14 Studies conducted by the Canadian government and by Dr. Firstman of the Georgia Institute of Technology detected only negligible differences. 15 The industry also relies on Borden v. Commissioner of Pub. Health, No. 38,478, slip. op. (Mass.Super.Ct. Jan. 19, 1982), which overturned as arbitrary and capricious a state ban of UFFI. The Borden court specifically found that there has been no showing that the ambient level of formaldehyde concentration in houses in which UFFI has been properly installed is significantly more appreciable or different than the level of formaldehyde in houses without UFFI. Slip op. at 20. 29 The Commission contends that the Frank, Firstman, and Canadian studies were invalid. None of the three considered the length of time that had elapsed since installation of the UFFI, a vital factor in the level of formaldehyde emitted. Therefore, they do not support the claim that UFFI adds only trace amounts of formaldehyde to the home environment. 30 The agency also defends its use of Franklin/Oak Ridge Labs data. It argues that the conditions to which the panels were exposed before testing were no worse than would exist in a home without heating or air-conditioning. The Commission does not address other concerns raised by the industry about the Franklin/Oak Ridge Labs studies, but nevertheless concludes that the study was valid because its results were similar to those obtained in the in-home tests. Two significant omissions with respect to the in-home tests cloud this conclusion. The Commission does not explain its reliance on a data base comprised largely of complaint houses. Nor does the agency justify its failure to conduct a study of randomly selected UFFI homes before issuing the product ban. 31 We do not reach the conclusion the Borden court did. The studies relied on by the industry do not demonstrate conclusively that formaldehyde levels in UFFI and non-UFFI homes are essentially the same. As the Commission notes, age is a vital factor in the level of formaldehyde emitted by UFFI. The in-home and Franklin/Oak Ridge Labs studies do suggest that UFFI appreciably raises in-home formaldehyde levels. 32 But the Commission did not use the studies only to support such a generalized finding. They were also incorporated into an exacting, precise, and extremely complicated risk assessment model. The goal of the model was to determine the risk of cancer to a consumer living in an average UFFI home. The difficulty in reaching this goal is that neither the in-home nor the Franklin/Oak Ridge Labs studies were consistent with this aim. The in-home study focused on complaint residences, not average residences, not randomly selected residences. The Franklin/Oak Ridge Labs studies reflected conditions similar to an unheated, unair-conditioned home, not an average home. The similar results achieved by the two studies validate neither. The studies were inadequate to serve as a data base for the Global 79 risk assessment. 33
34 The industry next contends that the numerous studies of humans exposed to formaldehyde in the workplace discredit the Commission's finding that formaldehyde is carcinogenic at low levels. Eleven epidemiologic studies involving a total of 10,000 workers were introduced into the record. None of the studies' authors found a statistically significant increase in the number of cancers among workers exposed to formaldehyde compared to the general population. The largest studies were conducted by Dr. Marsh, who found no nasal cancer and no dose-response relationship between formaldehyde exposure and other respiratory cancers among 2,490 formaldehyde workers; Drs. Walrath and Fraumeni of the National Cancer Institute, who found no nasal cancer mortality and no unusual respiratory cancer mortality in their study of 1,106 morticians; and Dr. Wong of Tabershaw Occupational Medical Associates, who found no nasal cancer mortality or excess respiratory cancer mortality among 2,026 formaldehyde workers. Dr. Wong concluded that at this point there is no epidemiologic evidence that formaldehyde is a human carcinogen. 35 The industry also relies on studies that were not completed until after the close of the record. The Federal Panel on Formaldehyde, which was convened by the Commission to assess the carcinogenicity of formaldehyde, stated in its recommendations to the agency that three pending studies of embalmers would provide a good estimate of potential risk from formaldehyde exposure. 16 Results in two of the three have now been released. 17 In neither were nasal cancers or excess respiratory cancers found. 36 Finally, the industry points to statements made by Dr. Higginson, former director of the International Agency for Research on Cancer, in a letter submitted to the Commission shortly before issuance of the ban. Dr. Higginson stated that the epidemiologic data are insufficient to exclude a minimal risk, but certainly they weigh heavily against the view that formaldehyde constitutes any considerable risk for nasal cancer to man. He also wrote that [e]xact estimates as to the number of cases of a cancer that might be expected to occur in man based on a single experiment [the Chemical Institute rat study] are silly and simply ignore biological realities. 37 The Commission defends its reliance on the Chemical Institute rat data by reminding us that the Federal Panel found the study valid and concluded that formaldehyde should be presumed to pose a carcinogenic risk to humans. The agency rejects the industry's contention that the available epidemiologic evidence demonstrates that formaldehyde is safe. The Commission points to the small number of workers involved in the epidemiologic studies and their failure to account for the duration and concentration of formaldehyde exposure. 38 Again, the truth appears to lie somewhere between the positions taken by the Commission and the industry. We agree with the agency that the epidemiologic studies cited by the industry do not demonstrate conclusively that formaldehyde poses no cancer risk to man. The Commission concluded that the increased risk of cancer from formaldehyde exposure (at the levels it attributed to UFFI) was up to approximately 1 in 20,000 (51 in a million). It is highly unlikely that studies involving a total of 10,000 workers would detect such a small risk. Additionally, the failure to consider either the length of time the workers were exposed to formaldehyde or the levels to which they were exposed diminishes the studies' usefulness. 39 While the Commission correctly notes that the epidemiologic evidence is not conclusive, its exclusive reliance on the Chemical Institute study in its Global 79 risk assessment is equally unsupportable. In the study 240 rats were exposed to an average of 14.3 ppm formaldehyde for six hours a day, five days a week. 18 After 24 months 103 of the rats developed nasal carcinomas. This was the only empirical datum with respect to formaldehyde carcinogenicity that was incorporated into the Global 79 model. But in a study as small as this one the margin of error is inherently large. For example, had 20 fewer rats, or 20 more, developed carcinomas, the risk predicted by Global 79 would be altered drastically. 40 The element of doubt present here is similar to that with respect to formaldehyde levels. The Federal Panel's findings that the Chemical Institute study was valid and that formaldehyde should be presumed to pose a cancer risk to man do not authenticate the use of the study's results, and only those results, to predict exactly the cancer risk UFFI poses to man. As Dr. Higginson aptly stated, it is not good science to rely on a single experiment, particularly one involving only 240 subjects, to make precise estimates of cancer risk. 41 This problem is exacerbated by concerns about the Chemical Institute study raised by the industry. Although the average level of formaldehyde exposure in the experiment was 14.3 ppm, the rats in fact were exposed regularly to much higher doses. Measurements of between 17 and 20 ppm were not uncommon. The highest recorded level was a near-lethal 32.4 ppm. We do not have to agree with the industry that this disparity renders the study invalid for all purposes to conclude that the Commission could not properly use the study as it did. To make precise estimates, precise data are required.
42 The industry attacks the Commission's cancer findings on several other grounds. Most of these relate to assumptions made by the Commission in its risk assessment. Although several of these contentions present substantial questions, 19 we do not address them. The predictions made by the risk assessment model are no better than the data base. We have concluded that this base was inadequate. The Commission improperly relied on in-home data gathered largely from complaint homes. It failed to conduct a controlled study of randomly selected residences. The result is that the Commission's finding that UFFI poses an unreasonable risk of cancer is not supported by substantial evidence on the record as a whole. 20