{"id":6959,"date":"2012-04-01T00:00:00","date_gmt":"2012-04-01T00:00:00","guid":{"rendered":"https:\/\/insulation.org\/io\/articles\/cancer-warning-labels-removed-from-fiberglass-building-insulation-products\/"},"modified":"2012-04-01T00:00:00","modified_gmt":"2012-04-01T00:00:00","slug":"cancer-warning-labels-removed-from-fiberglass-building-insulation-products","status":"publish","type":"articles","link":"https:\/\/insulation.org\/io\/articles\/cancer-warning-labels-removed-from-fiberglass-building-insulation-products\/","title":{"rendered":"Cancer Warning Labels Removed from Fiberglass Building Insulation Products"},"content":{"rendered":"

The
\nNorth American Insulation Manufacturers Association (“NAIMA”) and its
\nfiberglass member companies have promoted the usefulness and safety of
\nfiberglass insulation products since the 1930s. Throughout the years, NAIMA has
\nasserted that “biosoluble” fiber, fiber that readily dissolves in the lungs, is
\nsafe to manufacture, install and use when the proper work processes are
\nfollowed. <\/span><\/p>\n

Man-made vitreous fibers were identified as a possible
\ncarcinogen in 1987 by the International Agency for Research on Cancer (“IARC”).
\nThese claims were later adopted by domestic governmental bodies. However, since
\nthen, scientists, both internationally and domestically, have questioned the
\nevidence backing the classification of fiberglass as a carcinogen. Medical and
\nscientific evidence has been collected and analyzed from groups in the United
\nStates, United Kingdom, Canada, The Netherlands, Australia, New Zealand, and
\nothers since the 1930s. <\/span><\/p>\n

In October 2001, IARC changed the classification of
\n“insulation glass wool,” moving it from Group 2B (possibly carcinogenic) to
\nGroup 3 (not classifiable as to its carcinogenicity to humans).”1<\/sup><\/span><\/p>\n

Recent
\nDevelopments in the United States<\/span><\/b><\/p>\n

On
\nJune 10, 2011, the National Toxicology Program (NTP) removed from its list of
\n“Reasonably Anticipated To Be Carcinogens” biosoluble glass wool fibers used
\nfor home and building insulation, drawing a distinction between biosoluble
\nglass wool fibers and “certain glass wool fibers (inhalable) [that are]
\nreasonably anticipated to be human carcinogens” in an explanatory fact sheet.
\nThe fact sheet notes “Not all glass wool fibers cause cancer. Certain refers to
\nthose fibers that can enter the respiratory tract, are more durable, and remain
\nin the lungs for long periods of time.”2<\/sup> The NTP action means that a
\ncancer warning label for biosoluble fiberglass home and building insulation is
\nno longer required under federal law. Home and building insulation that will no
\nlonger carry a cancer warning label include fiberglass residential, commercial,
\nand industrial insulation products; specifically, fiberglass pipe and board
\nproducts will not carry a cancer warning label. In fact, the United States was
\nthe only remaining jurisdiction in the world where biosoluble fiberglass
\ninsulation was required to carry a cancer warning label.<\/span><\/p>\n

Also in 2011, the California Office of Environmental Health
\nHazard Assessment (OEHHA) published a modification of its Proposition 65
\nlisting to include only “glass wool fibers (inhalable and biopersistent).”3<\/sup>
\nThe OEHHA action means that a cancer warning label for biosoluble fiberglass
\nhome and building insulation is no longer required under California law.<\/span><\/p>\n

Delisting fiberglass insulation from the NTP’s Report on
\nCarcinogens (RoC) and California’s Prop. 65 list of carcinogens is consistent
\nwith the findings or conclusions reported by the IARC4<\/sup> in 2002; the
\nNational Academy of Sciences (NAS)5<\/sup> in 2000; the Agency for Toxic
\nSubstances and Disease Registry (ATSDR) in 20046<\/sup>; and Health Canada7<\/sup>
\nin 1993.<\/span><\/p>\n

What is a
\nBiosoluble Fiber?<\/span><\/b><\/p>\n

Before any further discussion on these two significant
\ndevelopments, it is imperative that the reader understand the meaning of
\n“biosoluble.” A “biosoluble” fiber is one that readily dissolves in the lung.
\n“Biopersistent” fibers are fibers that remain in the lungs for a longer time.
\nThese more durable fibers are not used for insulation and represent a small
\npercentage of glass wool fibers produced in the United States; biopersistent fibers
\nactually constitute less than one percent of the glass wool fibers produced in
\nthe United States. Biopersistent fibers are “used for high-efficiency air
\nfiltration media, acid battery separators and certain fine-diameter glass
\nfibres.”8<\/sup><\/span> <\/span><\/p>\n

To identify those fibers described by NTP and California as
\nbiosoluble, NAIMA and its members have adopted as a policy the European Union
\n(EU) criteria to identify which fibers require cancer warning labels under U.S.
\nand California requirements. The EU provides a scientific classification system
\nfor differentiating and distinguishing between those glass fibers that require
\na cancer warning label from those that do not. The EU system relies on
\nstandardized in vivo protocols. For additional details, the reader may consult
\nthe EU Guidelines ECB\/TM27 rev. 7.9<\/sup><\/span><\/p>\n

The Historical
\nBackdrop<\/span><\/b><\/p>\n

The
\nlabeling of fiberglass insulation as a possible carcinogen had its genesis in
\nanimal implantation studies. Implantation is a non-physiological route of
\nexposure. These studies literally injected or surgically implanted large
\nquantities of fibers directly into the abdomen, pleura (lining of the chest and
\nlungs), or trachea of the animals, bypassing the animals’ normal respiratory
\nsystems’ protective mechanisms. Some of these studies resulted in tumors.10<\/sup><\/span><\/p>\n

Relying upon the studies where tumors occurred in animals
\nafter implantation, IARC, in 1988, classified fiberglass as a possible
\ncarcinogen. California’s OEHHA (Prop. 65) and NTP followed shortly thereafter
\nwith similar listings. These listings were based on the animal implantation
\nstudies, however.11<\/sup> Over time, most in the scientific community
\nagreed that these implantation studies were not appropriate for characterizing
\nhuman health risk.12<\/sup> It was the consensus of a World Health
\nOrganization (WHO) panel of fiber toxicologists that these non-physiological
\nmethods of administering fibers to animals were not appropriate substitutes for
\ninhalation studies for assessing risk of fibers to human health.13<\/sup><\/span><\/p>\n

As the legitimacy of implantation studies was called into
\nquestion, a series of inhalation studies was conducted at RCC Laboratories in
\nGeneva, Switzerland. The results of these studies demonstrated that animals
\nexposed through inhalation to large doses of glass wool fibers did not develop
\ntumors.14<\/sup> With this animal data and expanded human epidemiological
\ndata, IARC revisited its earlier decision. In October 2001, a panel of
\ninternational experts reviewed the data and concluded that fiberglass and rock
\nand slag wool fibers used for thermal and acoustical insulation were considered
\n“not classifiable as to carcinogenicity to humans (Group 3).” IARC noted
\nspecifically:<\/span><\/p>\n

“Epidemiologic studies published during
\nthe 15 years since the previous IARC Monographs review of these fibres in 1988
\nprovide no evidence of increased risks of lung cancer or of mesothelioma
\n(cancer of the lining of the body cavities) from occupational exposures during
\nmanufacture of these materials, and inadequate evidence overall of any cancer
\nrisk.”<\/span> 15<\/sup><\/span><\/p>\n

IARC also included a Group 3 classification for continuous
\nglass filaments and the Group 2B “possible carcinogen” classification for
\ncertain special-purpose glass wools also known as biopersistent fibers.16<\/sup><\/span><\/p>\n

Catching Up With
\nthe Rest of the World<\/span><\/b><\/p>\n

After
\nthe IARC decision, the United States was the only jurisdiction in the world
\nthat required a cancer warning label on biosoluble fiberglass insulation. NAIMA
\nimmediately petitioned the NTP seeking a similar delisting from the RoC. In
\nsubmitting comments to NTP, NAIMA emphasized that glass wool fibers delisted by
\nIARC are not classified and labeled as carcinogens outside the United States.
\nUnder this scenario, a company could produce a glass wool fiber product at a
\nplant in the United States and ship it to Europe, Canada, or anywhere else in
\nthe world without a cancer warning label. If that identical product was
\ndistributed in the United States, it would be required to carry a cancer
\nwarning label.<\/span><\/p>\n

It is useful to understand that to be listed on the RoC,
\ncertain criteria must be satisfied (published in the Report on Carcinogens,
\nTwelfth Edition [12th RoC]):<\/span><\/p>\n

– <\/span>Known To Be Human Carcinogen:<\/span><\/b><\/p>\n

There is sufficient evidence of
\ncarcinogenicity from studies in humans, which indicates a causal relationship
\nbetween exposure to the agent, substance, or mixture, and human cancer.<\/span><\/p>\n

– <\/span>Reasonably Anticipated To Be Human
\nCarcinogen:<\/span><\/b><\/p>\n

There is limited evidence of
\ncarcinogenicity from studies in humans, which indicates that causal
\ninterpretation is credible, but that alternative explanations, such as chance,
\nbias, or confounding factors, could not adequately be excluded,<\/span><\/p>\n

<\/span>or<\/span><\/b><\/p>\n

there is sufficient evidence of
\ncarcinogenicity from studies in experimental animals, which indicates there is
\nan increased incidence of malignant and\/or a combination of malignant and
\nbenign tumors (1) in multiple species or at multiple tissue sites, or (2) by
\nmultiple routes of exposure, or (3) to an unusual degree with regard to
\nincidence, site, or type of tumor, or age at onset,<\/span><\/p>\n

<\/span>or<\/span><\/b><\/p>\n

there is less than sufficient
\nevidence of carcinogenicity in humans or laboratory animals; however, the
\nagent, substance, or mixture belongs to a well-defined, structurally related
\nclass of substances whose members are listed in a previous Report on
\nCarcinogens as either known to be a human carcinogen or reasonably anticipated
\nto be a human carcinogen, or there is convincing relevant information that the
\nagent acts through mechanisms indicating it would likely cause cancer in
\nhumans.<\/span><\/p>\n

Conclusions regarding carcinogenicity in humans or
\nexperimental animals are based on scientific judgment, with consideration given
\nto all relevant information. Relevant information includes, but is not limited
\nto, dose response, route of exposure, chemical structure, metabolism,
\npharmacokinetics, sensitive sub-populations, genetic effects, or other data
\nrelating to mechanism of action or factors that may be unique to a given
\nsubstance. For example, there may be substances for which there is evidence of
\ncarcinogenicity in laboratory animals, but there are compelling data indicating
\nthat the agent acts through mechanisms that do not operate in humans and would
\ntherefore not reasonably be anticipated to cause cancer in humans.<\/span><\/p>\n

This evidence can include traditional cancer epidemiology
\nstudies, data from clinical studies, and\/or data derived from the study of
\ntissues or cells from humans exposed to the substance in question, which can be
\nuseful for evaluating whether a relevant cancer mechanism is operating in
\nhumans.<\/span><\/p>\n

\u00a0The 12th RoC profile for certain glass wool fibers
\n(inhalable) indicated that biosoluble glass wool fibers do not meet the
\ncriteria for listing. Shortly after the NTP action, California’s OEHHA
\npublished a modification to its Prop. 65 listing to include only “Glass wool
\nfibers (inhalable and biopersistent).”17<\/sup><\/span><\/p>\n

Conclusion<\/span><\/b><\/p>\n

IARC,
\nNTP, and California’s Prop. 65 do not often remove substances from their lists
\nof carcinogens. NAIMA and its members are not surprised by the recent
\ndevelopment, however, because they are supported by medical and scientific evidence.
\nNAIMA restates that “Fiberglass insulation products are safe to manufacture,
\ninstall and use when recommended work practices are followed.”18<\/sup><\/span><\/p>\n

 <\/span><\/p>\n<\/div>\n

References:<\/span><\/b><\/p>\n

    <\/p>\n

  1. The various classifications include Group 1 (carcinogenic
    \nto humans), Group 2A (probably carcinogenic to humans), Group 2B (possibly
    \ncarcinogenic to humans), Group 3 (not classifiable as to its carcinogenicity to
    \nhumans), and Group 4 (probably not carcinogenic to humans). See http:\/\/monographs.iarc.fr\/ENG\/Monographs\/vol81\/mono81.pdf.<\/i><\/span><\/p>\n

  2. National Institute of Environmental Health Sciences,
    \nNational Toxicology Program, Fact Sheet, “The Report on Carcinogens,” June
    \n2011. See http:\/\/www.niehs.nih.gov\/health\/materials\/the_report_on_carcinogens_12th_edition.pdf
    \n<\/i>\u00a0<\/span><\/p>\n

  3. 46-Z California Regulatory Notice Register, p. 1878
    \n(November 18, 2011). http:\/\/www.oal.ca.gov\/res\/docs\/pdf\/notice\/46z-2011.pdf <\/i><\/span><\/p>\n

  4. International Agency for Research on Cancer, IARC
    \nMonographs on the Evaluation of Carcinogenic Risks to Humans: Man-Made Vitreous
    \nFibres,<\/i> Vol. 81 (Lyon, France: WHO\/IARC, 2002).<\/span><\/p>\n

  5. NRC Subcommittee on Manufactured Vitreous Fibers. 2000.
    \nReview of the U.S. Navy’s Exposure Standard for Manufactured Vitreous Fibers.
    \nNational Academy of Sciences, National Research Council, Washington, D.C.:
    \nNational Academy Press.<\/span><\/p>\n

  6. Toxicological Profile for Synthetic Vitreous Fibers<\/i>
    \n(U.S. Department of Health and Human Services, Public Health Services, Agency
    \nfor Toxic Substances and Disease Registry), September 2004.<\/span><\/p>\n

  7. Environment Canada. 1993. Mineral Fibres (Man-Made
    \nVitreous Fibres), Priority Substance Assessment Report,<\/i> p. 5.<\/span><\/p>\n

  8. IARC Monograph 81, p. 52.<\/span><\/p>\n

  9. http:\/\/tsar.jrc.ec.europa.eu\/documents\/Testing-Methods\/mmmfweb.pdf.<\/i><\/span><\/p>\n

  10. Hesterberg, W., et al.,<\/i> “Chronic Inhalation Toxicity
    \nof Size-Separated Glass Fibers in Fischer 344 Rats,” 20 Fund. & Appl.
    \nToxicol. 464-76 (1993); Bunn, W.B., et al., Recent Studies of Man-Made Vitreous
    \nFibres ? Chronic Animal Inhalation Studies,” 35 J. Occup. Med. 101 (1993).<\/span><\/p>\n

  11. International Agency for Research on Cancer, IARC
    \nMonographs on the Evaluation of Carcinogenic Risks to Human: Man-made Mineral
    \nFibres and Radon, <\/i>Vol. 43 (Lyon, France: WHO\/IARC, 1988), pp. 148-49, 152.<\/span><\/p>\n

  12. Environmental Protection Agency, “Health Hazard Assessment
    \nof Nonasbestos Fibers,” Final Draft (Dec. 30, 1988).<\/span><\/p>\n

  13. WHO, European Programme For Occupational Health, “Validity
    \nof Methods for Assessing the Carcinogenicity of Man-Made Fibers,” Executive
    \nSummary of a WHO Consultation (May 19-20, 1992).<\/span><\/p>\n

  14. Hesterberg, W., et al.,<\/i> “Chronic Inhalation Toxicity
    \nof Size-Separated Glass Fibers in Fischer 344 Rats,” 20 Fund. & Appl.
    \nToxicol. 464-76 (1993); Bunn, W.B., et al.,<\/i> Recent Studies of Man-Made
    \nVitreous Fibres ? Chronic Animal Inhalation Studies,” 35 J. Occup. Med. 101
    \n(1993).<\/span><\/p>\n

  15. IARC Press Release, 24 October 2001 (http:\/\/www.iarc.fr\/en\/media-centre\/pr\/2001\/pr137.html).<\/i><\/span><\/p>\n

  16. World Health Organization International Agency for Research
    \non Cancer, IARC Monographs on the Evaluation of Carcinogenic Risks to
    \nHumans: Man-Made Vitreous Fibres,<\/i> Vol. 81 (Lyon, France: WHO\/IARC, 2002). http:\/\/monographs.iarc.fr\/ENG\/Monographs\/vol81\/volume81.pdf<\/i><\/span><\/p>\n

  17. 46-Z California Regulatory Notice
    \nRegister, p. 1878 (November 18, 2011). http:\/\/www.oal.ca.gov\/res\/docs\/pdf\/notice\/46z-2011.pdf<\/i><\/span><\/p>\n

  18. Recommended work practices are designed to reduce temporary
    \nmechanical irritation. Note that this mechanical irritation does not meet the
    \nU.S. OSHA HAZCOM definition of irritation as set forth in Appendix A to 29
    \nC.F.R. \u00a7 1910.1200.<\/span><\/p>\n

    <\/OL><\/p>\n

    Disclaimer:<\/span><\/b> Unless specifically noted at the
    \nbeginning of the article, the content, calculations, and opinions expressed by
    \nthe author of any article in Insulation Outlook are those of the author and do not
    \nnecessarily reflect the views of NIA.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

    The North American Insulation Manufacturers Association (“NAIMA”) and its fiberglass member companies have promoted the usefulness and safety of fiberglass insulation products since the 1930s. Throughout the years, NAIMA has asserted that “biosoluble” fiber, fiber that readily dissolves in the lungs, is safe to manufacture, install and use when the proper work processes are followed.<\/p>\n","protected":false},"author":[55],"featured_media":0,"template":"","categories":[37,38,24,21,291,32],"class_list":["post-6959","articles","type-articles","status-publish","hentry","category-market-research","category-material-selection","category-contracting","category-business-managment","category-association-news","category-health-and-safety","author-angus-e-crane"],"acf":[],"yoast_head":"\nCancer Warning Labels Removed from Fiberglass Building Insulation Products - Insulation Outlook Magazine<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/insulation.org\/io\/articles\/cancer-warning-labels-removed-from-fiberglass-building-insulation-products\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cancer Warning Labels Removed from Fiberglass Building Insulation Products\" \/>\n<meta property=\"og:description\" content=\"The North American Insulation Manufacturers Association (“NAIMA”) and its fiberglass member companies have promoted the usefulness and safety of fiberglass insulation products since the 1930s. Throughout the years, NAIMA has asserted that “biosoluble” fiber, fiber that readily dissolves in the lungs, is safe to manufacture, install and use when the proper work processes are followed.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/insulation.org\/io\/articles\/cancer-warning-labels-removed-from-fiberglass-building-insulation-products\/\" \/>\n<meta property=\"og:site_name\" content=\"Insulation Outlook Magazine\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"10 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/insulation.org\/io\/articles\/cancer-warning-labels-removed-from-fiberglass-building-insulation-products\/\",\"url\":\"https:\/\/insulation.org\/io\/articles\/cancer-warning-labels-removed-from-fiberglass-building-insulation-products\/\",\"name\":\"Cancer Warning Labels Removed from Fiberglass Building Insulation Products - Insulation Outlook Magazine\",\"isPartOf\":{\"@id\":\"https:\/\/insulation.org\/io\/#website\"},\"datePublished\":\"2012-04-01T00:00:00+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/insulation.org\/io\/articles\/cancer-warning-labels-removed-from-fiberglass-building-insulation-products\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/insulation.org\/io\/articles\/cancer-warning-labels-removed-from-fiberglass-building-insulation-products\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/insulation.org\/io\/articles\/cancer-warning-labels-removed-from-fiberglass-building-insulation-products\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/insulation.org\/io\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Cancer Warning Labels Removed from Fiberglass Building Insulation Products\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/insulation.org\/io\/#website\",\"url\":\"https:\/\/insulation.org\/io\/\",\"name\":\"Insulation Outlook Magazine\",\"description\":\"The only global magazine dedicated to insulation.\",\"publisher\":{\"@id\":\"https:\/\/insulation.org\/io\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/insulation.org\/io\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/insulation.org\/io\/#organization\",\"name\":\"National Insulation Association\",\"url\":\"https:\/\/insulation.org\/io\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/insulation.org\/io\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/insulation.org\/io\/wp-content\/uploads\/sites\/3\/2016\/10\/insulation-outlook-logo.png\",\"contentUrl\":\"https:\/\/insulation.org\/io\/wp-content\/uploads\/sites\/3\/2016\/10\/insulation-outlook-logo.png\",\"width\":229,\"height\":90,\"caption\":\"National Insulation Association\"},\"image\":{\"@id\":\"https:\/\/insulation.org\/io\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Cancer Warning Labels Removed from Fiberglass Building Insulation Products - Insulation Outlook Magazine","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/insulation.org\/io\/articles\/cancer-warning-labels-removed-from-fiberglass-building-insulation-products\/","og_locale":"en_US","og_type":"article","og_title":"Cancer Warning Labels Removed from Fiberglass Building Insulation Products","og_description":"The North American Insulation Manufacturers Association (“NAIMA”) and its fiberglass member companies have promoted the usefulness and safety of fiberglass insulation products since the 1930s. 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