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Article ; Online: Lack of data drives uncertainty in PCB health risk assessments.

Cogliano, Vincent James

Environmental science and pollution research international

2016 Volume 23, Issue 3, Page(s) 2212–2219

Abstract: Health risk assessments generally involve many extrapolations: for example, from animals to humans or from high doses to lower doses. Health risk assessments for PCBs involve all the usual uncertainties, plus additional uncertainties due to the nature of ...

Abstract	Health risk assessments generally involve many extrapolations: for example, from animals to humans or from high doses to lower doses. Health risk assessments for PCBs involve all the usual uncertainties, plus additional uncertainties due to the nature of PCBs as a dynamic, complex mixture. Environmental processes alter PCB mixtures after release into the environment, so that people are exposed to mixtures that might not resemble the mixtures where there are toxicity data. This paper discusses the evolution of understanding in assessments of the cancer and noncancer effects of PCBs. It identifies where a lack of data in the past contributed to significant uncertainty and where new data subsequently altered the prevailing understanding of the toxicity of PCB mixtures, either qualitatively or quantitatively. Finally, the paper identifies some uncertainties remaining for current PCB health assessments, particularly those that result from a lack of data on exposure through nursing or on effects from inhalation of PCBs.
MeSH term(s)	Data Collection/methods ; Data Collection/standards ; Humans ; Neoplasms/etiology ; Polychlorinated Biphenyls/toxicity ; Risk Assessment/methods ; Risk Assessment/standards ; Uncertainty
Chemical Substances	Polychlorinated Biphenyls (DFC2HB4I0K)
Language	English
Publishing date	2016-02
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1178791-0
ISSN	1614-7499 ; 0944-1344
ISSN (online)	1614-7499
ISSN	0944-1344
DOI	10.1007/s11356-015-5157-4
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Article ; Online: The IARC Monographs: a resource for precaution and prevention.

Cogliano, Vincent James

Occupational and environmental medicine

2007 Volume 64, Issue 9, Page(s) 572

MeSH term(s)	Carcinogenicity Tests/methods ; Conflict of Interest ; Environmental Health/standards ; Female ; Humans ; Male ; Peer Review, Research ; Public Health/standards ; Publication Bias
Language	English
Publishing date	2007-09
Publishing country	England
Document type	Comment ; Journal Article
ZDB-ID	1180733-7
ISSN	1470-7926 ; 1351-0711
ISSN (online)	1470-7926
ISSN	1351-0711
DOI	10.1136/oem.2006.031872
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Article: Use of carcinogenicity bioassays in the IARC monographs.

Cogliano, Vincent James

Annals of the New York Academy of Sciences

2006 Volume 1076, Page(s) 592–600

Abstract: Carcinogenicity bioassays generally provide the best means of assessing the potential for a chemical to be a human carcinogenic hazard. The results of carcinogenicity bioassays are usually the key determinants of IARC Monograph evaluations. Along with ... ...

Abstract	Carcinogenicity bioassays generally provide the best means of assessing the potential for a chemical to be a human carcinogenic hazard. The results of carcinogenicity bioassays are usually the key determinants of IARC Monograph evaluations. Along with carcinogenicity bioassays and epidemiological studies, the International Agency for Research on Cancer (IARC) also encourages the consideration of mechanistic data and other relevant data. During 2005 IARC is updating the Preamble to the IARC Monographs, which describes the principles and procedures used in developing the Monographs, including the criteria that guide the evaluations. Proposed revisions to the Preamble make some changes in the criteria for evaluating carcinogenicity in experimental animals to reflect the greater confidence that can be placed in Good Laboratory Practice (GLP) studies. Other changes will give more specific guidance for the evaluation of mechanistic data. Sections on mechanistic data will be given more prominence in future Monographs and will be more closely linked with toxicokinetics. Future Monographs will also include a new section on susceptible individuals, populations, and life stages that will often be based on the understanding of mechanisms. In addition, the draft Preamble discusses IARC's procedures for promoting impartial evaluations by avoiding conflicts of interests and ensuring that working groups are free from interference.
MeSH term(s)	Animals ; Biological Assay ; Carcinogenicity Tests
Language	English
Publishing date	2006-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	211003-9
ISSN	1749-6632 ; 0077-8923
ISSN (online)	1749-6632
ISSN	0077-8923
DOI	10.1196/annals.1371.014
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Article: Current criteria to establish human carcinogens.

Cogliano, Vincent James

Seminars in cancer biology

2004 Volume 14, Issue 6, Page(s) 407–412

Abstract: Several national and international health agencies worldwide have established carcinogen identification programs with the aim of identifying the agents and exposures that contribute to the global burden of cancer. These programs have many features in ... ...

Abstract	Several national and international health agencies worldwide have established carcinogen identification programs with the aim of identifying the agents and exposures that contribute to the global burden of cancer. These programs have many features in common. IARC's program is described in some detail, with an emphasis on how evaluations can be changed by mechanistic data. Recently, several programs have expanded on the guidance they provide in assessing mechanistic data. The most comprehensive example is EPA's recent draft final Guidelines for Carcinogen Risk Assessment. In all programs, however, the principal role of mechanistic information has been to support the positive results observed in epidemiological studies or to discount the relevance of positive results observed in experimental animal bioassays. An alternative paradigm for carcinogen identification is proposed, one where mechanistic studies have a central role, rather than a supporting one. Under this paradigm, potentially carcinogenic agents would be identified by (1) identifying the key precursor events and processes involved in human cancer and (2) testing to see whether an agent can affect these events and processes. Under this paradigm, which is consistent with a multi-factorial view of carcinogenesis, it might be possible to identify carcinogens through mechanistic understanding alone, without waiting for epidemiological studies or 2-year carcinogenesis bioassays in rats and mice. This paradigm asks the question, "What is a human carcinogen? Is it an agent that we observe to induce tumors, or more generally, an agent with a clear role in tumor development?"
MeSH term(s)	Animals ; Carcinogenicity Tests ; Carcinogens/isolation & purification ; Carcinogens/pharmacology ; Humans ; Neoplasms/chemically induced ; Neoplasms/pathology
Chemical Substances	Carcinogens
Language	English
Publishing date	2004-12
Publishing country	England
Document type	Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	1033980-2
ISSN	1096-3650 ; 1044-579X
ISSN (online)	1096-3650
ISSN	1044-579X
DOI	10.1016/j.semcancer.2004.06.003
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Article ; Online: Conducting evaluations of evidence that are transparent, timely and can lead to health-protective actions.

Chartres, Nicholas / Sass, Jennifer B / Gee, David / Bălan, Simona A / Birnbaum, Linda / Cogliano, Vincent James / Cooper, Courtney / Fedinick, Kristi Pullen / Harrison, Roy M / Kolossa-Gehring, Marike / Mandrioli, Daniele / Mitchell, Mark A / Norris, Susan L / Portier, Christopher J / Straif, Kurt / Vermeire, Theo

Environmental health : a global access science source

2022 Volume 21, Issue 1, Page(s) 123

Abstract: Background: In February 2021, over one hundred scientists and policy experts participated in a web-based Workshop to discuss the ways that divergent evaluations of evidence and scientific uncertainties are used to delay timely protection of human health ...

Abstract	Background: In February 2021, over one hundred scientists and policy experts participated in a web-based Workshop to discuss the ways that divergent evaluations of evidence and scientific uncertainties are used to delay timely protection of human health and the environment from exposures to hazardous agents. The Workshop arose from a previous workshop organized by the European Environment Agency (EEA) in 2008 and which also drew on case studies from the EEA reports on 'Late Lessons from Early Warnings' (2001, 2013). These reports documented dozens of hazardous agents including many chemicals, for which risk reduction measures were delayed for decades after scientists and others had issued early and later warnings about the harm likely to be caused by those agents. Results: Workshop participants used recent case studies including Perfluorooctanoic acid (PFOA), Extremely Low Frequency - Electrical Magnetic Fields (ELF-EMF fields), glyphosate, and Bisphenol A (BPA) to explore myriad reasons for divergent outcomes of evaluations, which has led to delayed and inadequate protection of the public's health. Strategies to overcome these barriers must, therefore, at a minimum include approaches that 1) Make better use of existing data and information, 2) Ensure timeliness, 3) Increase transparency, consistency and minimize bias in evidence evaluations, and 4) Minimize the influence of financial conflicts of interest. Conclusion: The recommendations should enhance the production of "actionable evidence," that is, reliable evaluations of the scientific evidence to support timely actions to protect health and environments from exposures to hazardous agents. The recommendations are applicable to policy and regulatory settings at the local, state, federal and international levels.
Language	English
Publishing date	2022-12-05
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2092232-2
ISSN	1476-069X ; 1476-069X
ISSN (online)	1476-069X
ISSN	1476-069X
DOI	10.1186/s12940-022-00926-z
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Article ; Online: Updating IARC's carcinogenicity assessment of benzene.

Cogliano, Vincent James / Baan, Robert / Straif, Kurt

American journal of industrial medicine

2011 Volume 54, Issue 2, Page(s) 165–167

MeSH term(s)	Benzene/toxicity ; Carcinogens, Environmental/toxicity ; Congresses as Topic ; Humans ; International Agencies ; Internationality ; Leukemia, Lymphocytic, Chronic, B-Cell/epidemiology ; Multiple Myeloma/epidemiology ; Neoplasms/chemically induced ; Neoplasms/epidemiology ; Occupational Diseases/chemically induced ; Occupational Diseases/epidemiology ; Occupational Exposure/adverse effects ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/epidemiology ; Risk Assessment ; United States/epidemiology
Chemical Substances	Carcinogens, Environmental ; Benzene (J64922108F)
Language	English
Publishing date	2011-02
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	604538-8
ISSN	1097-0274 ; 0271-3586
ISSN (online)	1097-0274
ISSN	0271-3586
DOI	10.1002/ajim.20916
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Article ; Online: The Emergence of Systematic Review in Toxicology.

Stephens, Martin L / Betts, Kellyn / Beck, Nancy B / Cogliano, Vincent / Dickersin, Kay / Fitzpatrick, Suzanne / Freeman, James / Gray, George / Hartung, Thomas / McPartland, Jennifer / Rooney, Andrew A / Scherer, Roberta W / Verloo, Didier / Hoffmann, Sebastian

Toxicological sciences : an official journal of the Society of Toxicology

2016 Volume 152, Issue 1, Page(s) 10–16

Abstract: The Evidence-based Toxicology Collaboration hosted a workshop on "The Emergence of Systematic Review and Related Evidence-based Approaches in Toxicology," on November 21, 2014 in Baltimore, Maryland. The workshop featured speakers from agencies and ... ...

Abstract	The Evidence-based Toxicology Collaboration hosted a workshop on "The Emergence of Systematic Review and Related Evidence-based Approaches in Toxicology," on November 21, 2014 in Baltimore, Maryland. The workshop featured speakers from agencies and organizations applying systematic review approaches to questions in toxicology, speakers with experience in conducting systematic reviews in medicine and healthcare, and stakeholders in industry, government, academia, and non-governmental organizations. Based on the workshop presentations and discussion, here we address the state of systematic review methods in toxicology, historical antecedents in both medicine and toxicology, challenges to the translation of systematic review from medicine to toxicology, and thoughts on the way forward. We conclude with a recommendation that as various agencies and organizations adapt systematic review methods, they continue to work together to ensure that there is a harmonized process for how the basic elements of systematic review methods are applied in toxicology.
MeSH term(s)	Animals ; Humans ; Biomedical Research/methods ; Biomedical Research/standards ; Consensus ; Guidelines as Topic ; Toxicology/methods ; Toxicology/standards ; Systematic Reviews as Topic
Language	English
Publishing date	2016-05-05
Publishing country	United States
Document type	Congress
ZDB-ID	1420885-4
ISSN	1096-0929 ; 1096-6080
ISSN (online)	1096-0929
ISSN	1096-6080
DOI	10.1093/toxsci/kfw059
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Article: Use of mechanistic data in IARC evaluations.

Cogliano, Vincent James / Baan, Robert A / Straif, Kurt / Grosse, Yann / Secretan, Béatrice / El Ghissassi, Fatiha

Environmental and molecular mutagenesis

2008 Volume 49, Issue 2, Page(s) 100–109

Abstract: Consideration of mechanistic data has the potential to improve the analysis of both epidemiologic studies and cancer bioassays. IARC has a classification system in which mechanistic data can play a pivotal role. Since 1991, IARC has allowed an agent to ... ...

Abstract	Consideration of mechanistic data has the potential to improve the analysis of both epidemiologic studies and cancer bioassays. IARC has a classification system in which mechanistic data can play a pivotal role. Since 1991, IARC has allowed an agent to be classified as carcinogenic to humans (Group 1) when there is less than sufficient evidence in humans but there is sufficient evidence in experimental animals and "strong evidence in exposed humans that the agent acts through a relevant mechanism of carcinogenicity." Mechanistic evidence can also substitute for conventional cancer bioassays when there is less than sufficient evidence in experimental animals, just as mechanistic evidence can substitute for conventional epidemiologic studies when there is less than sufficient evidence in humans. The IARC Monographs have used mechanistic data to raise or lower a classification that would be otherwise based on epidemiologic studies and cancer bioassays only. Recently, the IARC Monographs have evaluated several agents where mechanistic data were pivotal to the overall evaluation: benzo[a]pyrene, carbon black and other poorly soluble particles, ingested nitrates and nitrites, and microcystin-LR. In evaluating mechanistic data, it is important to consider alternative mechanistic hypotheses, because an agent may induce tumors through multiple mechanisms.
MeSH term(s)	Animals ; Benzo(a)pyrene/classification ; Benzo(a)pyrene/toxicity ; Carcinogens/classification ; Carcinogens/toxicity ; Humans ; International Agencies ; Microcystins/classification ; Microcystins/toxicity ; Neoplasms/chemically induced ; Nitrates/classification ; Nitrates/toxicity ; Nitrites/classification ; Nitrites/toxicity ; Soot/classification ; Soot/toxicity
Chemical Substances	Carcinogens ; Microcystins ; Nitrates ; Nitrites ; Soot ; Benzo(a)pyrene (3417WMA06D) ; cyanoginosin LR (EQ8332842Y)
Language	English
Publishing date	2008-03
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	639145-x
ISSN	1098-2280 ; 0893-6692
ISSN (online)	1098-2280
ISSN	0893-6692
DOI	10.1002/em.20370
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Article: Use of mechanistic data in IARC evaluations

Cogliano, Vincent James / Baan, Robert A / Straif, Kurt / Grosse, Yann / Secretan, Béatrice / El Ghissassi, Fatiha

Environmental and molecular mutagenesis. 2008 Mar., v. 49, no. 2

2008

Abstract	Consideration of mechanistic data has the potential to improve the analysis of both epidemiologic studies and cancer bioassays. IARC has a classification system in which mechanistic data can play a pivotal role. Since 1991, IARC has allowed an agent to be classified as carcinogenic to humans (Group 1) when there is less than sufficient evidence in humans but there is sufficient evidence in experimental animals and "strong evidence in exposed humans that the agent acts through a relevant mechanism of carcinogenicity." Mechanistic evidence can also substitute for conventional cancer bioassays when there is less than sufficient evidence in experimental animals, just as mechanistic evidence can substitute for conventional epidemiologic studies when there is less than sufficient evidence in humans. The IARC Monographs have used mechanistic data to raise or lower a classification that would be otherwise based on epidemiologic studies and cancer bioassays only. Recently, the IARC Monographs have evaluated several agents where mechanistic data were pivotal to the overall evaluation: benzo[a]pyrene, carbon black and other poorly soluble particles, ingested nitrates and nitrites, and microcystin-LR. In evaluating mechanistic data, it is important to consider alternative mechanistic hypotheses, because an agent may induce tumors through multiple mechanisms. Environ. Mol. Mutagen., 2008.
Language	English
Dates of publication	2008-03
Size	p. 100-109.
Publishing place	Wiley Subscription Services, Inc., A Wiley Company
Document type	Article
ZDB-ID	639145-x
ISSN	0893-6692
ISSN	0893-6692
DOI	10.1002/em.20370
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Article ; Online: Preventable exposures associated with human cancers.

Cogliano, Vincent James / Baan, Robert / Straif, Kurt / Grosse, Yann / Lauby-Secretan, Béatrice / El Ghissassi, Fatiha / Bouvard, Véronique / Benbrahim-Tallaa, Lamia / Guha, Neela / Freeman, Crystal / Galichet, Laurent / Wild, Christopher P

Journal of the National Cancer Institute

2011 Volume 103, Issue 24, Page(s) 1827–1839

Abstract: Information on the causes of cancer at specific sites is important to cancer control planners, cancer researchers, cancer patients, and the general public. The International Agency for Research on Cancer (IARC) Monograph series, which has classified ... ...

Abstract	Information on the causes of cancer at specific sites is important to cancer control planners, cancer researchers, cancer patients, and the general public. The International Agency for Research on Cancer (IARC) Monograph series, which has classified human carcinogens for more than 40 years, recently completed a review to provide up-to-date information on the cancer sites associated with more than 100 carcinogenic agents. Based on IARC's review, we listed the cancer sites associated with each agent and then rearranged this information to list the known and suspected causes of cancer at each site. We also summarized the rationale for classifications that were based on mechanistic data. This information, based on the forthcoming IARC Monographs Volume 100, offers insights into the current state-of-the-science of carcinogen identification. Use of mechanistic data to identify carcinogens is increasing, and epidemiological research is identifying additional carcinogens and cancer sites or confirming carcinogenic potential under conditions of lower exposure. Nevertheless, some common human cancers still have few (or no) identified causal agents.
MeSH term(s)	Alcohol Drinking/adverse effects ; Carcinogens, Environmental/toxicity ; Environmental Exposure/adverse effects ; Global Health ; Humans ; International Agencies ; Meat Products/adverse effects ; Neoplasms/chemically induced ; Neoplasms/epidemiology ; Neoplasms/etiology ; Neoplasms/prevention & control ; Neoplasms/virology ; Risk Factors ; Smoking/adverse effects ; Virus Diseases/complications
Chemical Substances	Carcinogens, Environmental
Language	English
Publishing date	2011-12-12
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2992-0
ISSN	1460-2105 ; 0027-8874 ; 0198-0157
ISSN (online)	1460-2105
ISSN	0027-8874 ; 0198-0157
DOI	10.1093/jnci/djr483
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