CDC/ATSDR — Formaldehyde Levels: Request for Correction (RFC)

09/03/2009

September 3,2009

Centers for Disease Control and Prevention 
CDC/ATSDR, Attn: MASO, MS-E11 
1600 Clifton Road, NE 
Atlanta, GA 30333

Re:       Request for Correction of Information under the Information Quality Act of Statements Regarding Formaldehyde in the CDC report, Final Report on Formaldehyde Levels in FEMA-Supplied Travel Trailers, Park Models, and Mobile Homes (July 2, 2008)

Dear Sir/Madam:

This Request for Correction (RFC) of information is submitted by the Formaldehyde Council, Inc. (FCI) under the Information Quality Act (lQA)1 and implementing guidelines issued by the Office of Management and Budget (OMB)2, the U.S. Department of Health and Human Services (HHS)3, and the Centers for Disease Control (CDC)4. The FCI is a group of leading formaldehyde producers and users who are dedicated to promoting the responsible use and benefits of formaldehyde and ensuring its accurate scientific evaluations5. For these reasons, FCI respectfully requests that CDC correct three statements about the health effects of formaldehyde found in the CDC Report on Formaldehyde Levels in FEMA-Supplied Travel Trailers, Park Models, and Mobile Homes (July 2, 2008) (Final Report)6. These statements are not supported by the scientific literature and do not meet CDC's information quality assurance of the scientific literature and do not meet CDC's information quality assurance of "objectivity," that is, that the information is "presented in an accurate clear, complete and unbiased manner7."

I. IQA BACKGROUND AND APPLICABILITY TO THE FINAL REPORT

A. Overview

Congress enacted the IQA to "ensur[e] and maximiz[e] the quality, objectivity, utility and integrity of information ... disseminated by Federal agencies" like the CDC. To do so, it required the OMS to issue government-wide implementing guidance8. It also instructed each agency to issue its own guidelines, which have two functions:

  1. to apply the OMS Guidelines to the agency's particular circumstances, and
  2. to "establish administrative mechanisms allowing affected persons to seek and obtain correction of information ... disseminated by the agency that does not comply with the [OMS] guidelines...9

OMS issued its final guidelines in February 2002. HHS issued department-wide guidelines10, and CDC issued its own agency-specific guidelines11.

OMB's Guidelines require that all disseminations meet "a basic standard of quality ... appropriate to the nature and timeliness of the information ....12 They define "quality" in terms of objectivity, utility and integrity13. "Objectivity' is centrally relevant in cases of scientific health assessments. As discussed below, objectivity has significant consequences both for the substance of such information and the way it is presented. "Utility" also is important in this case, as it refers to the usefulness of the information to its intended users including the public14.

B. Objectivity -Substance

From a substantive perspective, "objectivity" means that information must be accurate, reliable and unbiased15. Scientific information must be generated using sound statistical and research methods16. Additionally, "influential" scientific information must be sufficiently transparent to be reproduced, subject to several caveats17. This means, with respect to analytical results, that agencies must provide "sufficient transparency about data and methods that an independent reanalysis could be undertaken by a qualified member of the public"18.

 

Influential information regarding risks to health, safety or the environment must be based on "the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and ... data collected by accepted methods or best available methods…"19

C. Objectivity -Presentation

From the perspective of presentation, "objectivity" means that information must be presented in an accurate, clear, complete and unbiased manner, which includes presentation in the proper context20. The sources of the information must be disclosed, subject to confidentiality and privacy limits, and where appropriate, data should have full, accurate and transparent documentation, with sources of error identified21. Scientific, financial and statistical information must accompanied by supporting data and models22. Influential information regarding risks to health, safety or the environment must be comprehensive, informative and understandable, and must specify, among other things, (i) each significant uncertainty and studies that would assist in resolving the same, and (ii) peer-reviewed studies that support, are directly relevant to or fail to support estimates and methodologies used to reconcile inconsistencies in data23.

D. The Final Report Must Have Utility

The OMB IQA guidelines define "utility" in terms of:

the usefulness of the information to its intended users, including the public. In assessing the usefulness of information that the agency disseminates to the public, the agency needs to consider the uses of the information not only from the perspective of the agency but also from the perspective of the public24.

 

This often underestimated requirement is important because it goes to the heart of why an agency is disseminating information in the first place. To the extent that a final report misstates or overstates the carcinogenicity of a substance, for example, the report and documents based on it are not useful to other federal or state agencies whose regulatory or policy resources will now be misdirected. It also is not useful to the public, who will be misled as to the potential impact or prevalence of carcinogens in their environment, and this may lead to unnecessary actions to protect themselves from substances that are not, in fact, hazardous as characterized.

II. DETAILED DISCUSSION OF IQA DEFICIENCIES AND REQUIRED CORRECTIONS

A. Overview

FCI specifically requests that CDC withdraw the following statements on page 4 of the report, none of which are supported by the scientific literature or by the citations provided in the report and that are directly contradicted by CDC's own ATSDR Toxicological Profile for Formaldehyde25:

  1. "... upper respiratory tract irritation can exacerbate symptoms of asthma and other respiratory illnesses .... “
  2. "... however, formaldehyde-sensitive persons have reported symptoms at levels around 100 ppb [parts per billion] ... Additional studies have found health effects at 100 ppb in sensitive persons chronically exposed to formaldehyde  ... “
  3. "Sensitive and sensitized persons can experience symptoms without detecting odor and thus receive little or no warning of exposure ..."

Discussed in greater detail below are the reasons why each of these statements should be withdrawn. We also provide the suggested corrections with supporting documentation. FCI believes these statements should be withdrawn not only because they are scientifically unsupported, but also because the statements are being repeated in other government documents citing the CDC report in support26. The health effects of formaldehyde are very well characterized and FCI believes that the extent to which it poses a risk to public health should be conveyed accurately based on the best available science.

B. Inaccurate statement #1

“... upper respiratory tract irritation can exacerbate symptoms of asthma and other respiratory illnesses (Main et al., 1983; Bracken et aI., 1985; Kilburn et aI., 1985; Imbus et aI., 1985; Anderson et al., 1979)."

This statement is not supported by the citations provided or by reviews from other government bodies, including CDC's ATSDR. Page 236 of ATSDR's Toxicological Profile for Formaldehyde states, "Two populations of humans have received considerable attention in the literature as being particularly sensitive to formaldehyde exposure following inhalation and/or dermal exposure. The first population is asthmatics, and concern focuses on the changes in lung function parameters that formaldehyde may produce ... Most of these studies concluded that there is no evidence of increased airway reactivity as a result of formaldehyde exposure in either normal or asthmatic individuals. Formaldehyde exposures at the concentrations tested (usually >3 ppm [parts per million]) did not exacerbate existing asthmatic conditions, either at rest or after exercise."

A recent National Academy of Sciences report summarizes the available controlled clinical studies evaluating the irritant effects of formaldehyde in asthmatic and non-­asthmatic individuals, finding no differences in sensitivity between the two groups. The report concludes that "asthmatic individuals exposed to airborne formaldehyde at exposure concentrations at or below 3 ppm do not appear to be at greater risk of suffering airway dysfunction than non-asthmatic individuals[27]."

In its review of health risks from formaldehyde, the Australian government concludes that "Lung function tests suggest that asthmatics no more sensitive to formaldehyde than healthy subjects28." The same document also notes. "Furthermore, although asthmatics are thought to be more sensitive to irritants, studies by Green et al. (1987), Sauder et al. (1986, 1987) and Witek et al. have demonstrated that at concentrations of 2-3 ppm (2.4 3.6 mg/m ) for up to 3 hours, asthmatics were no more sensitive to formaldehyde than non-asthmatics."

The studies cited in the CDC report allegedly supporting the referenced statement are poorly controlled (if at all), confounded by other exposures (in virtually every study), conducted on a biased sample of people (e.g., individuals, who due to adverse publicity, agreed to have their homes tested), lacking in adequate measurements of actual formaldehyde exposure and, upon review, simply do not support the statement. In one case (Anderson et al. 1979) exposed mice were studied, not humans. Oddly, none of the many controlled clinical studies (summarized in Table 5-2 of the NAS/NRC 2007 report) -the most reliable scientifically- are even mentioned in the CDC report, suggesting that the authors "cherry-picked" the studies they believed supported their views and did not objectively evaluate the weight of the scientific evidence.

FCI respectfully requests that the referenced CDC report statement be withdrawn and replaced with text along the lines of the following: "Sensory irritation is the most sensitive effect of inhalation exposure to formaldehyde (ATSDR 1999). While some occupational and residential studies suggest that formaldehyde may exacerbate the symptoms of asthma, most do not (ATSDR 1999). Controlled clinical studies have found no differences in sensitivity to sensory irritation between asthmatics and non-­asthmatics and that even high exposures to formaldehyde (> 3 ppm) do not exacerbate asthma (ATSDR 1999, NAS/NRC 2007, NICNAS 2006)."

C. Inaccurate statement #2

"At 800 ppb, nearly everyone develops some acute irritative symptoms; however, formaldehyde-sensitive persons have reported symptoms at levels around 100 ppb (Main et aI., 1983; Bender et aI., 1983). Additional studies have found health effects at 100 ppb in sensitive persons chronically exposed to formaldehyde (Ritchie et al.. 1987)."

While some people might experience symptoms at 800 ppb, it is incorrect to state that this is what everyone will experience. Clinical studies with human volunteers have documented quite clearly that exposure to 1 ppm is the lowest level producing effects not confounded by false positives (see below). In contrast, the statements about reported effects at 100 ppb are demonstrably incorrect and not supported by any credible scientific data. Critical evaluation of the extensive data base available on formaldehyde's dose-response relationship involving sensory irritation indicates that effects do not occur below 300 ppb. In fact, a concentration of 100 ppb would be considered a health-protective exposure level at which adverse effects are not expected to occur in anyone including children, potentially sensitive individuals, and asthmatics.

Controlled clinical studies of formaldehyde provide the most scientifically supportable and reliable basis for drawing conclusions about the exposure concentrations of formaldehyde expected to produce irritant effects. There are at least 20 published studies or critical reviews of studies available evaluating respiratory function and irritation of the eyes, nose, and throat in human volunteers in controlled clinical settings. This large body of data, now reviewed or relied upon by numerous regulatory and authoritative bodies world-wide (e.g. US. Environmental Protection Agency (EPA), National Academies of Science (NAS), Canada, Australia, Germany, Organization for Economic Co-operation and Development (OECD), and the World Health Organization (WHO), permits a far more accurate assessment of formaldehyde levels associated with sensory irritation than the inappropriate studies cited in the CDC statement #2 that we are seeking to correct.

Clinical studies are conducted in exposure chambers where individuals are exposed to known concentrations of formaldehyde and to clean air in order to unequivocally demonstrate the airborne concentrations of formaldehyde that can reliably elicit symptoms of sensory irritation in the absence of any potential confounders. Such studies are far superior to studies conducted in occupational or residential settings in terms of being able to measure accurately the formaldehyde concentrations associated with sensory irritation in the absence of confounders such as active smoking, other chemicals, wood dust, environmental tobacco smoke, smoke from wood fires, cooking fumes, house dust, pet dander, molds, fungi, etc. Clinical studies in which some people are intentionally exposed to formaldehyde concentrations below 1 ppm while some are exposed to clean air (i.e., formaldehyde-free) have found that 20-30% of those exposed to clean air will report responses of sensory irritation (i.e., false positives)29. In the most recent controlled study of this type (Lang et al. 2008),21 subjects (11 males and 10 females) were exposed to concentrations of formaldehyde of 0, 0.3, and 0.5 ppm with peaks up to 1.0 ppm and with the odor masked in some situations. The no-observed effect level (NOEL) was 0.5 ppm for subjective and objective eye irritation (i.e., blinking frequency, redness, reaction times, etc.) due to formaldehyde exposure, with a constant exposure level and 0.3 ppm with peaks of 0.6 ppm for short-term exposures30.

Astonishingly, the CDC report does not cite a single one of the controlled clinical studies as the basis for its conclusions about indoor air levels associated with symptoms of sensory irritation. Instead, to support its conclusions about reported effects at 100 ppb, CDC cites one residential and one occupational exposure study. The residential study involved self-reported complaints of sensory irritation by people who already believed their symptoms were attributable to formaldehyde [Ritchie & Lehnen (1987), mis-cited by CDC as 'Ritchie et al (1987)]. Measurements of formaldehyde concentrations in the homes of those reporting symptoms were classified as <100 ppb, 100 to 300 ppb, and ppb. Measurements of other potential irritants were not made but smoking status was reported. Virtually no effects were reported in the homes with <100 ppb. Effects were reported in 10-27% of the homes with 100 to 300 ppb. However, as indicated above, in controlled studies 20-30% of people exposed to clean air (but who believed they were being exposed to formaldehyde) reported irritant effects, so the likelihood that the effects reported in those homes are attributable to formaldehyde must be questioned. While more than 60% of subjects reported symptoms at air concentrations ppm, there is no way to know what the actual exposure levels were because the authors failed to provide any analytical data on this key issue. Effects reported at <100 ppb were almost certainly false positives (because no controlled human study has demonstrated that anyone can detect this concentration) and, even if some of the effects reported between 100 to 300 ppb were real (and not themselves false positives), the study design does not permit any conclusions whatsoever to be drawn about effects at 100 ppb.

In the Main & Hogan (1983) study [mis-cited by CDC as Main et al. (1983)], information about irritant effects was obtained via a questionnaire from 21 workers whose offices were in trailers and 19 workers who did not work in trailers Eighty percent of the workers were smokers. Measurements of the trailers' formaldehyde concentrations on three occasions produced results between 0.12 and 1.6 ppm after the trailers had been closed over the weekend. Symptoms of irritation were significantly greater among those working in trailers than those not working in trailers. There was no attempt to correlate specific measurements with the presence or absence of symptoms, nor were measurements taken in workers' homes or in the workplaces of those not working in trailers. The results of this study clearly do not support the conclusion that the irritant effects of formaldehyde occur at 100 ppb.

The third study oddly cited by CDC in support if its conclusion that effects occur at 100 ppb (Bender et al. 1983) was, in fact, a controlled clinical study that never even tested a concentration of 100 ppb. In fact, the authors of this study actually reported effects above "slight" occurring only at 1,000 ppb. Responses at 350, 560, 700, and 900 ppb, the other concentrations tested, were reported on average as "less than slight" irritation and did not differ from responses reported by subjects exposed to clean air. Clearly this study does not support CDC's conclusion.

Finally, it should be noted that EPA has conducted a critical analysis of controlled human exposure data to derive human health effects criteria for formaldehyde31. Response data from six human volunteer studies comprising 250 observations and subjects' reported symptoms were categorized into numerical descriptors of symptoms:

(0) no effect noted or reported; (1) mild signs and symptoms; (2) moderate signs and symptoms; (3) severe signs and symptoms. From these data, a number of mathematical models were used to assess responses. The report noted that "An important advantage of this approach is that all relevant data can be used in the derivation as opposed to a NOAEL for the critical effect. The benefit of doing so allows health risks to be estimated across various exposure levels." This approach was also endorsed by EPA's Science Advisory Board, which observed that the process used "... makes use of every bit of data available ...' This detailed modeling process showed a clear threshold at 0.5 ppm for any symptoms of sensory irritation and an effective concentration of 1.5 ppm for moderate effects.

It seems highly unlikely that CDC was not aware of the many controlled human exposure studies available for formaldehyde, particularly because many of those studies are cited in the ATSDR Toxicological Profile for Formaldehyde. Indeed, FCI wrote to CDC, and. in a letter32dated May 6, 2008, raised some of the same issues raised here, even to the extent of citing the EPA (2005) study cited in footnote 30 of this Available controlled exposure studies convincingly document that no adverse health effects occur at 100 ppb and, in fact, virtually all of the individual studies as well as comprehensive reviews of the entire body of data have determined that exposures of less than 300 ppb will not produce adverse effects. In this regard, it must be noted that when ATSDR (2007) performed the first Health Consultation to determine formaldehyde levels in unoccupied FEMA temporary housing units, a target indoor air concentration of 300 ppb formaldehyde was chosen specifically because this level was "below the level of concern for sensitive individuals." That concentration was not picked out of thin air, but rather was taken from ATSDR documents and is the same level selected by the National Academy of Sciences (and numerous other entities) as a continuous exposure guidance level for formaldehyde33. As noted by NAS, 'Reported symptoms of eye and mucous membrane irritation at that concentration [300 ppb] were not increased above control conditions in controlled chamber studies." The CDC report does not objectively evaluate the weight of the scientific evidence regarding formaldehyde exposure levels and effects and instead cites studies that, when evaluated critically, do not support CDC's statement that effects occur at 100 ppb.

FCI respectfully requests that CDC withdraw the referenced statements asserting that adverse effects occur at formaldehyde exposure concentrations of 100 ppb and suggests replacing them with text along the lines of the following: "A number of controlled human studies have evaluated the formaldehyde concentrations associated with sensory irritation. These are reviewed in ATSDR (1999), NAS/NRC (2007), and Australia/NICNAS (2006). Taken together, the available studies indicate that sensory irritation may at exposure concentrations exceeding 300 ppb."

D. Inaccurate statement #3

"Sensitive and sensitized persons can experience symptoms without detecting odor and thus receive little or no warning of exposure (Kulle et al. 1987; Weisel et al. 2005)."

There is no evidence that inhaled formaldehyde is capable of sensitizing the respiratory tract. According to pages 254 and 215 of ATSDR's Toxicological Profile for Formaldehyde: "Although formaldehyde is widely recognized as a dermal irritant that can sensitize the skin in humans, the evidence for immunologically-mediated sensitization of the respiratory tract from exposure to airborne formaldehyde is weak," and "Animal studies examining the sensitizing properties of formaldehyde present evidence consistent with the hypothesis that, although formaldehyde can sensitize skin, it apparently lacks a potential to sensitize the respiratory tract (Hilton et al. 1996)." According to Australia's National Industrial Chemicals Notification and Assessment Scheme (NICNAS) report on formaldehyde. "The available human and animal data indicate gaseous formaldehyde is unlikely to induce respiratory sensitisation34." Many of the controlled human studies of formaldehyde have included potentially sensitive individuals such as asthmatics and people who claim to have a heightened sensitivity to formaldehyde, with no evidence that either of those groups is particularly susceptible to formaldehyde-induced sensory irritation.

The study by Kulle et al. (1987) is another odd one to cite in support of the referenced inaccurate statement because neither sensitive nor sensitized persons were tested in this controlled human volunteer study. Instead, this study involved exposure to formaldehyde at 0.0, 0.5, 1, 2, and 3 ppm for up to 3 hours, with the authors noting that "At 0.5 ppm HCHO for 3 h none of our nine subjects had eye irritation, while at 1.0 ppm for 3 h three of 19 experienced mild eye irritation and one experienced moderate irritation." The study by Weisel et al. (2005) is also an odd one to cite, as it has nothing to do with formaldehyde per se, but rather is a methods development study involving concentrations of a suite of volatile organic compounds, carbonyl compounds, and airborne particulate matter. This study does not address the issue of sensitive or sensitized persons.

Thus, while it is true that there is evidence indicating that dermal exposure to liquid formaldehyde can sensitize the skin, the exposures in question involving FEMA trailers occurred via inhalation, so the dermal route of exposure is not relevant. Furthermore, the citations provided in the CDC report do not even discuss the issues of sensitization or odor detection as a warning of exposure and thus clearly do not support CDC's statement in that regard. In fact, formaldehyde, like the majority of other odiferous compounds, has an odor threshold that is less than its irritant threshold 35.

We respectfully suggest that the statement be deleted. The sentence that precedes it in the CDC report makes the relevant point that formaldehyde's odor threshold is above residential exposure levels.

III. IMPACT OF THE DOCUMENT ON FCI AND ITS MEMBERS

A. CDC is a Recognized and Influential Authority on Health Effects

Consistent with its mission, CDC is a recognized authority on information that people and communities use to protect their health through health promotion, health education, prevention of disease, and preparedness. The CDC Final Report has been a basis for action and comment by other agencies, such as the Federal Emergency Management Agency and other segments of the Department of Homeland Security. In addition, the CDC report was widely reported by the media.

Toxicology descriptions by CDC are highly influential and assumed to be based on the best scientific evidence available. The dissemination of incorrect or misleading information on formaldehyde is currently having an adverse impact on FCI and its member companies. Health effects information from CDC is used as a basis for action by federal, state, and local governments as well private interests ranging from builders to home owners. If information from CDC does not meet IQA requirements, direct and substantial economic and reputational damage to the industry that FCI represents will result. It is thus important that the Final Report and other pronouncements by CDC be accurate, reliable, unbiased, clear, complete and transparent in substance and presentation. The report in its present form does not meet these criteria.

B. Adverse Effects of the Final Report

FCI is a nonprofit trade association that represents the leading producers and users of formaldehyde in the United States who are dedicated to promoting the responsible use of formaldehyde. FCI is committed to advancing the state of scientific understanding on potential toxicological, epidemiological, and environmental effects related to formaldehyde, as well as providing accurate technical and scientific information relating to potential exposures, uses and effects of formaldehyde or formaldehyde-based products36.

While there is little formaldehyde present in most final products, the chemical is an essential component in making common consumer items including medicines, vaccines, paper towels, furniture, cabinets, insulation and other building products, photographic film, computers, bulletproof vests, and windshields. In the automobile industry, formaldehyde-based products can be found in molded under-the-hood components, exterior primer and clear coat paints, tire cord adhesive, brake pads, and critical fuel system components, while in the aircraft industry its applications include essential landing gear components, lubricants, brake pads, and door and window insulation. In health care applications, it is used for vaccine manufacturing, as a denaturant for RNA analysis, as an active ingredient in anti-infective drugs, for hard gel capsule manufacturing, and in pharmaceutical research, especially proteomics and genomics research.

Deselection of products derived from formaldehyde would harm not only those FCI members who produce and use formaldehyde-based packaging, but also the environment and consumers if substitute products have inferior performance, environmental, or public health attributes.

The home building and home improvement industries are highly competitive. Because some products that use formaldehyde-based chemistry are well known or visibly present in the home, they also are highly vulnerable to consumer perceptions of toxicity. If formaldehyde is inappropriately characterized, purchasers would deselect formaldehyde-based products. Competitors quickly and widely publicize such information, raising unfounded concerns about product toxicity and creating a false impression that well produced products pose a health risk when they do not.

The overall U.S. formaldehyde industry is a diversified industry and studies have shown that in the United States, production of formaldehyde and formaldehyde-containing goods accounts for more than 5% of the Gross National Product, which exceeds $10 trillion annually. Formaldehyde is essential to operations at nearly 50,000 U.S. facilities in 17 major industries, and it serves as a basic raw material in another 70 industries. Annual U.S. formaldehyde production exceeds 5 million metric tons. According to a 2005 Global Insight report, examples of formaldehyde's economic contributions include37:

  • More than $145 billion in annual sales come from formaldehyde-based industry activities.
  • Nearly 700,000 workers are employed in the formaldehyde industry and downstream manufacturing facilities in the United States and Canada; of these, more than 600,000 jobs are in the United States. Total annual wages for these employees amount to nearly $20 billion.
  • An additional 1.8 million workers in the United States and Canada are employed in the network of supplier industries that provide goods and services to the industry. Total annual wages for these workers are approximately $58 million.
  • Formaldehyde and derivatives production is carried out in facilities with an aggregate investment value of nearly $90 billion in the United States and Canada.
  • Approximately 11,900 formaldehyde and derivative plants operate in the United States and Canada in nearly all states and provinces.
  • Almost 60% of formaldehyde's estimated economic benefits are attributed to three major applications urea-formaldehyde resins, phenol formaldehyde resins, and MOl (methylenebis (4-phenyl isocyanate)). In most cases, consumers would be severely negatively impacted by having to use alternative materials, and large new capital investments would be required to produce or use the substitutes.

IV.    CONCLUSION

For the above-stated reasons, the IQA requires corrections to the CDC Final Report of July 2, 2008, by deleting the three above-identified statements. Similarly, any subsequent CDC documents based on the flawed Final Report should be withdrawn and, if reissued, be revised consistent with the corrected Final Report.

Thank you for considering FCI's RFC. We trust the information provided is helpful. We are available to discuss the issues raised or to provide further supporting information upon request.

Sincerely,

Betsy M. Natz

Executive Director

CC:      The Honorable Barbara Boxer, United States Senate 
The Honorable James Inhofe, United States Senate 
The Honorable David Vilter, United States Senate 
The Honorable Mary Landrieu, United States Senate 
The Honorable John D. Rockefeller, United States Senate 
The Honorable Kay Bailey Hutchison, United States Senate 
The Honorable Mark Pryor, United States Senate 
The Honorable Roger Wicker, United States Senate 
The Honorable Mike Enzi, United States Senate 
The Honorable Joseph Lieberman, United States Senate 
The Honorable Susan Collins, United States Senate 
The Honorable Robert Casey, United States Senate 
The Honorable Henry Waxman, U.S. House of Representatives 
The Honorable Joe Barton, U.S. House of Representatives 
The Honorable Bart Stupak, U.S. House of Representatives 
The Honorable John Shimkus, U.S. House of Representatives 
The Honorable Bennie Thompson, U.S. House of Representatives
The Honorable Peter King, U.S. House of Representatives 
The Honorable Bart Gordon, U.S. House of Representatives 
The Honorable Ralph Hall, U.S. House of Representatives 
The Honorable Brad Miller, U.S. House of Representatives 
The Honorable James Sensenbrenner, U.S. House of Representatives 
The Honorable Mark Souder, U.S. House of Representatives 
The Honorable Joe Donnelly. U.S. House of Representatives 
W. Craig Fugate, Administrator of the Federal Emergency Management Agency 

  1. Pub. L. No. 106-554, § 515, 114 Stat 2763A-153 to 2763A-154, 44 U.S.C. § 3516 note.
  2. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8,452 (Feb. 22, 2002).
  3. HHS, Guidelines for Ensuring the Quality of Information Disseminated to the Public, available at http://www.hhs.govlinfoquality/part1.html.
  4. US Department of Health and Human Services Guidelines for Ensuring the Quality of Information Disseminated to the Public. D. Centers for Disease Control and Prevention and Agency for Toxic Substances and Disease Registry. Section VA htto:llasoe.hhs.qov/infoguality/Guidelineslcdcinf02.shlrnl.
  5. FCI members include Agrolinz Melamin GmbH; American Forest and Paper Association: Arclin: Atlantic Methanol: Celanese Corporation; CertainTeed Corporation; DB Western, Inc.: DSM Melamine; E. I. du Pont de Nemours and Company; Formica Corporation; Georgia-Pacific LLC; Hexion Specialty Chemicals. Inc.; Cabinet Manufacturers Association; Methanex; Methanol Holdings (Trinidad) Limited; National Funeral Directors Association: Owens Coming; Panolam Industries International; Troy Corporation; and West Fraser Timber Co. Ltd.
  6. The report is available at http://www.cdc.govmceh/ehhe/trailerstudy/pdfsIFEMAFinaIReport.pdf.
  7. US Department of Health and Human Services, Guidelines for Ensuring the Quality of Infomnation Disseminated to the PUblic, D. Cenlers for Disease Control and Prevention and Agency for Toxic Substances and Disease Registry. Section VA http://aspe.hhs.gov/infoquality{Guidelines/Cdcinfo2.shtml.
  8. See note 2, supra.
  9. PUb. L. No. 106-554, note I'l supra. § 5' 5(b)(2)(B) (emphasis added)
  10. See note 3, supra.
  11. See note 4, supra.
  12. 67 Fed. Reg. at 8,458.
  13. Id. at 8459; cf 44 US.C. § 3504(e)(1)(8).
  14. Id.
  15. 67 Fed. Reg. at 8,549 (emphasis added).
  16. Id.
  17. Id. at 8,460.
  18. Id. at 8,460.
  19. Id.; see also 42 U.S.C. § 300g-1(b)(3)(A).
  20. Id. at 8,459 (emphasis added).
  21. Id.
  22. Id. at 8,460
  23. Id.; see also 42 U.S.C. § 300g-1(b)(3)(B).
  24. Id.
  25. Agency for Toxic SUbstances and Disease Registry (ATSDR) (1999). Tox'ICOlogical Profile for Formaldehyde. US Department of Health and Human Services, Centers for Disease Control and Prevention. Atlanta. GA.
  26. See, e.g., US Department of Homeland Security (2009). FEMA Response to Formaldehyde in Trailers. Qffice of the Inspector General. QIG-Q9-83. Washington, DC.
  27. National Academy of Sciences/National Research Council (2007). Emergency and Continuous Exposure Guidance Levels for Selected Submarine Contaminants. National Academies Press. Washington, DC. Page lOa and Table 5-2, pages 111-116.
  28. Australian Govemment Department of Health and Aging. National Industrial Chemicals Notification and Assessment Scheme (NICNAS) (2006). Formaldehyde. Priority Existing Chemical Assessment Report NO.28 www.nicnas.gov.au.
  29. See, e.g., Organization for Economic Cooperation and Development (OECD) (2002). Formaldehyde; SIDS Initial Assessment Profile. UNEP Publications; Bender, J. (2002). The use of noncancer endpoints as a basis for establishing a reference concentration for formaldehyde. RegUlatory Toxicology and Pharmacology 3523-31.
  30. Lang. I., Bruckner, 1. and Triebig. G. (2008). Formaldehyde and chemosensory irritation in humans: a controlled human exposure study. Regul. Toxicol. Pharmacol. 50(1 ):23-36.
  31. US Environmental Protection Agency (EPA) (2005). Controlled Exposure Formaldehyde Via Inhalation: A Categorical Regression Analysis of Human Exposure and Response. National Center for Environmental Assessment. Research Triangle Park, NC.
  32. Letter of May 6,2008, from Betsy Natz, Executive Director of FCI to Howard Frumkin, MD, DrPH, Director, National Center for Environmental Health. CDC. The May 2008 FCI letter was prompted by a February 29,2008 CDC report 'Interim Findings on Formaldehyde Levels in FEMA-Supplied Travel Trailers, Park Models, and Mobile Homes:
  33. EPA (2005) at 27.
  34. Op cit. 28.
  35. See, e.g., Arts JH, MUijser H, Kuper CF, and Woutersen RA (2006). Setting an indoor air exposure limit for formaldehyde: factors of concern. Regulatory Toxicology and Pharmacology 52: 189-194.
  36. For more information about the FCI Visit www.formaldehyde.org
  37. Global Insight, The Economic Benefits of Formaldehyde to the United States and Canadian Economies. LeXington, MA, August 2005.