Jump to comment:

• The IARC Monographs and the new Preamble
  Vincent James Cogliano
  Published on: 27 April 2016
• The IARC Monographs: a resource for precaution and prevention? The new Preamble does not fit.
  paolo crosignani
  Published on: 27 April 2016

• Published on: 27 April 2016

  The IARC Monographs and the new Preamble

  • Vincent James Cogliano, Head, IARC Monographs programme

  I would like to clarify two points from the response by Drs Crosignani and Gennaro[1] on the IARC Monographs as a resource for precaution and prevention.[2] First, the new formaldehyde Monograph[3] strengthened the evaluation of formaldehyde, and it would be a mistake to ignore formaldehyde as a workplace or environmental health hazard. The Monograph raised the classification from "probably carcinogenic" (Group 2A) to...

  Show More

  I would like to clarify two points from the response by Drs Crosignani and Gennaro[1] on the IARC Monographs as a resource for precaution and prevention.[2] First, the new formaldehyde Monograph[3] strengthened the evaluation of formaldehyde, and it would be a mistake to ignore formaldehyde as a workplace or environmental health hazard. The Monograph raised the classification from "probably carcinogenic" (Group 2A) to "carcinogenic to humans" (Group 1), the first time formaldehyde was so classified by any health agency. It also used the word “strong” in characterising the evidence on leukaemia, the first time concern was extended beyond the respiratory tract.

  Second, readers should understand that the new Preamble had nothing to do with identification of tumour sites for formaldehyde. Work on amending the Preamble[4] began the year after the June 2004 Monograph meeting on formaldehyde. Many earlier Monographs had identified tumour sites with sufficient evidence in humans, and three Advisory Groups recommended that this practice be continued and standardised by including it in the Preamble.[5,6,7] Tumour-site information is the subject of frequent requests and provides insight into the evaluation process, as evidence in humans is generally considered separately for each site.

  IARC actively sought the views of the scientific and public health communities when amending the Preamble and will continue to listen in order that the Monographs remain a valued resource for cancer prevention.

  Vincent Cogliano

  Head, IARC Monographs programme, International Agency for Research on Cancer, Lyon, France

  The author declares no conflicts of interests.

  References

  1 Crosignani P, Gennaro V. The IARC Monographs: a resource for precaution and prevention? The new Preamble does not fit. Occup Environ Med 5 Sept 2007; electronic letter

  2 Cogliano VJ. The IARC Monographs: a resource for precaution and prevention. Occup Environ Med 2007; 64: 572

  3 IARC. Formaldehyde, 2-butoxyethanol and 1-tert-butoxypropan-2-ol. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans 2006; 88: 39-325

  4 IARC. Process for amending the Preamble to the IARC Monographs. http://monographs.iarc.fr/ENG/Preamble/amendments.php

  5 Report of an ad-hoc IARC Monographs Advisory Group on priorities for future evaluations. IARC Internal Report 03/001, http://monographs.iarc.fr/ENG/Publications/internrep/03-001.pdf

  6 Report of the Advisory Group to recommend updates to the Preamble to the IARC Monographs, IARC Internal Report 05/001, http://monographs.iarc.fr/ENG/Preamble/Rep-AG-Preamble-05.pdf

  7 Report of the Advisory Group to review the amended Preamble to the IARC Monographs, IARC Internal Report 06/001, http://monographs.iarc.fr/ENG/Preamble/Preamble-IntReport.pdf

  Show Less

  Conflict of Interest:
  None declared.

  • Back to top
• Published on: 27 April 2016

  The IARC Monographs: a resource for precaution and prevention? The new Preamble does not fit.

  • paolo crosignani, MD
  • Other Contributors:
    • valerio gennaro, MD

  In the last issue of OEM, Cogliano (1) presented the IARC Monographs as a tool both for precaution and prevention. If true in the past, the new Preamble severely impairs this potential.

  In fact, a new task for the working group has been introduced: “the target organ(s) or tissue(s) in which an increase in cancer was observed is identified” and “A statement that there is sufficient evidence is followed by a separ...

  Show More

  In the last issue of OEM, Cogliano (1) presented the IARC Monographs as a tool both for precaution and prevention. If true in the past, the new Preamble severely impairs this potential.

  In fact, a new task for the working group has been introduced: “the target organ(s) or tissue(s) in which an increase in cancer was observed is identified” and “A statement that there is sufficient evidence is followed by a separate sentence that identifies the target organ(s) or tissue(s) in which an increase in cancer was observed in humans. Identification of a specific target organ or tissue does not preclude the possibility that the agent may cause cancer at other sites.”.

  This new preamble has been downloaded from IARC web site, but was not included in the most recent published volume (no 88). Nevertheless, the same Volume 88 reported: Page 276: “In summary, there is strong but not sufficient evidence for a causal association between leukaemia and occupational exposure to formaldehyde”. Page 277: “A number of studies have found associations between exposure to formaldehyde and cancer at other sites, including the oral cavity, oro- and hypo pharynx, pancreas, larynx, lung and brain. However, the Working Group considered that the overall balance of epidemiological evidence did not support a causal role for formaldehyde in relation to these other cancers” Moreover, about sinonasal cancer “there is only limited epidemiological evidence…”.

  Eventually, the only target organ recognised as causally linked to the exposure to formaldehyde was the nasopharyngeal cancer. This lead to the classification of formaldehyde as human carcinogen (Group 1).

  Nasopharyngeal cancer is a rare neoplasm in developed countries; its world-age-standardized rate is 0.7 among males and 0.2 among females, whereas lung cancer world- standardized rates are 54.9 and 17.0 respectively. (Data from IARC database GLOBOCAN 2002, accessed 20th August 2007).

  As a consequence, even though classified as a human carcinogen, exposure to formaldehyde ceases to be a work environment and a public health concern, as the only target organ is a rare neoplasm and more frequent cancer sites are explicitly excluded as possible targets.

  The issue of identification and exclusion of target organs in the Monograph series is of huge public health concern and should be publicly evaluated. In the new Preamble, no formal justification for this decision is given, nor the aim of identifying target organs is declared.

  The absence of evidence is not evidence of absence; even more, treating incomplete evidence as evidence of absence is at odds with the precautionary attitude that should surround these evaluations. In fact, the “balance of the epidemiological evidence”, as used in the Volume 88 to exclude all target organs other than nasopharynx, represent only the subjectivity of the majority of the working group (what means “strong but not sufficient” ?) and discards all epidemiological evidence . Moreover, this “balance” is unethical per se, as, as Cogliano (1) admits, “the scientific method tends to avoid false positives and tolerate false negatives”. Therefore this balance is indeed between two entities: people health, impaired by false negatives and the profits and advantages deriving from the usage of a chemical, protected by the extreme care paid to avoiding false positives.

  IARC Monographs have been and are an essential tool for the protection of the public health. The issue of identifying the target organ(s) impairs without any explainable reason this important role. Therefore I earnestly recommend that this issue should reconsidered by the scientific community, in its pros and cons. In the meantime that the summary of Vol. 88 should be properly amended.

  (1) Cogliano VJ. The IARC Monographs: a resource for precaution and prevention. Occup Environ Med 2007; 64: 572

  Paolo Crosignani, MD, Head, Environmental Epidemiology and Cancer Registry Unit National Cancer Institute Milan, Italy

  Valerio Gennaro, MD Epidemiology and Prevention Dpt. National Cancer Research Institute, Genova, Italy

  Show Less

  Conflict of Interest:
  None declared.

  • Back to top