Priority Substances List Assessment Report for Formaldehyde

1.0 Introduction

The Canadian Environmental Protection Act, 1999 (CEPA 1999) requires the federal Ministers of the Environment and of Health to prepare and publish a Priority Substances List (PSL) that identifies substances, including chemicals, groups of chemicals, effluents and wastes, that may be harmful to the environment or constitute a danger to human health. The Act also requires both Ministers to assess these substances and determine whether they are "toxic" or capable of becoming "toxic" as defined in Section 64 of the Act, which states:

... a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that

1. have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
2. constitute or may constitute a danger to the environment on which life depends; or
3. constitute or may constitute a danger in Canada to human life or health.
   

Substances that are assessed as "toxic" as defined in Section 64 may be placed on Schedule I of the Act and considered for possible risk management measures, such as regulations, guidelines, pollution prevention plans or codes of practice to control any aspect of their life cycle, from the research and development stage through manufacture, use, storage, transport and ultimate disposal.

Based on an initial screening of readily accessible information, the rationale for assessing formaldehyde provided by the Ministers' Expert Advisory Panel on the Second Priority Substances List (Ministers' Expert Advisory Panel, 1995) was as follows:

Canadians are exposed to formaldehyde through its production; its use in the production of resins; in automobile exhaust and cigarette smoke; and through the "off-gassing" of building materials and consumer products including cosmetics and household cleaning agents. Toxicological effects in animals and humans have been observed at levels similar to the concentrations to which the general population may be exposed. Formaldehyde is genotoxic and carcinogenic in rodents and may be carcinogenic in humans. An assessment is needed to determine the potential risk to human health.

Descriptions of the approaches to assessment of the effects of Priority Substances on the environment and human health are available in published companion documents. The document entitled "Environmental Assessments of Priority Substances under the Canadian Environmental Protection Act. Guidance Manual Version 1.0 - March 1997" (Environment Canada, 1997a) provides guidance for conducting environmental assessments of Priority Substances in Canada. This document may be purchased from:

• Environmental Protection Publications
  Environmental Technology Advancement Directorate
  Environment Canada
  Ottawa, Ontario
  K1A 0H3

It is also available on the Commercial Chemicals Evaluation Branch web site at www.ec.gc.ca/cceb1/ese/eng/esehome.htm under the heading "Guidance Manual." It should be noted that the approach outlined therein has evolved to incorporate recent developments in risk assessment methodology that will be addressed in future releases of the guidance manual for environmental assessments of Priority Substances.

The approach to assessment of effects on human health is outlined in the following publication of the Environmental Health Directorate of Health Canada: "Canadian Environmental Protection Act - Human Health Risk Assessment for Priority Substances" (Health Canada, 1994), copies of which are available from:

• Environmental Health Centre
  Room 104
  Health Canada
  Tunney's Pasture
  Ottawa, Ontario
  K1A 0L2

or on the Environmental Health Directorate publications web site (www.hc-sc.gc.ca/ehp/ehd/catalogue/bch.htm). The approach is also described in an article published in the Journal of Environmental Science and Health -Environmental Carcinogenesis & Ecotoxicology Reviews (Meek et al., 1994). It should be noted that the approach outlined therein has evolved to incorporate recent developments in risk assessment methodology, which are described on the Environmental Substances Division web site (www. hc-sc.gc.ca/ehp/ehd/bch/env_contaminants/psap/psap.htm) and which will be addressed in future releases of the approach paper for the assessment of effects on human health.

The search strategies employed in the identification of data relevant to assessment of potential effects on the environment (prior to December 1999) and human health (prior to January 1999) are presented in Appendix A. Available Canadian data on sources, use patterns and fate of formaldehyde in the environment have been emphasized. In supporting documentation for this assessment, a report on the health effects of formaldehyde prepared previously by the Bureau of Chemical Hazards, Health Canada (BCH, 1988), was updated. This was based, in part, on a background report compiled by BIBRA Toxicology International (BIBRA, 1994). Review articles were consulted where appropriate. However, all original studies that form the basis for determining whether formaldehyde is "toxic" under CEPA 1999 have been critically evaluated by staff of Environment Canada (entry and environmental exposure and effects) and Health Canada (human exposure and effects on human health).

An Environmental Resource Group was established by Environment Canada to assist in the preparation of the environmental assessment. Members participated in the preparation and review of the environmental sections of the Assessment Report and the environmental supporting document (Environment Canada, 1999a). Members included:

• G. Bird, Natural Resources Canada
• B. Brownlee, Environment Canada
• N. Bunce, University of Guelph
• R. Chénier, Environment Canada
• T. Currah, OxyChem Durez
• T. Dann, Environment Canada
• E. Dowdall, Environment Canada
• F. Edgecomb, Canadian Plastics Industry Association
• M. Eggleton, Environment Canada
• G. Granville, Shell Canada Limited
• L. Kamboj, Monsanto
• R. Keefe, Imperial Oil Limited
• G. Rideout, Environment Canada
• A. Stelzig, Environment Canada
• M. Tushingham, Environment Canada
• J. Wittwer, Environment Canada
  
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The environmental assessment was led by R. Chénier and coordinated by A. Bobra (AMBEC Environmental Consultants) on behalf of Environment Canada.

The sections of the Assessment Report relevant to the environmental assessment and the environmental supporting document were reviewed by members of the Environmental Resource Group, as well as by A. Day (Celanese Canada Inc.), D. Mackay (University of Toronto) and P. Makar (Environment Canada).

The content of the health-related sections of this Assessment Report and the supporting documentation (Health Canada, 1999, 2000) was prepared by the following staff of Health Canada:

• R. Beauchamp
• R.G. Liteplo
• M.E. Meek

M. Walker and J. Zielenski, Division of Biostatistics and Research Coordination, Health Canada, and D. Blakey and G. Douglas, Environmental and Occupational Toxicology Division, Health Canada, contributed to the preparation of sections on dose-response analyses for cancer and genotoxicity, respectively.

In the first stage of external review, background sections of the supporting documentation pertaining to human health were reviewed primarily to address adequacy of coverage. Written comments were provided by J. Acquavella (Monsanto Company), S. Felter (Toxicology Excellence for Risk Assessment), O. Hernandez (U.S. Environmental Protection Agency [EPA]), R. Keefe (Imperial Oil Limited), N. Krivanek (Dupont Haskell Laboratory), J. Martin (consultant) and F. Miller (Chemical Industry Institute of Toxicology [CIIT]) (June 1997).

In 1996, a government-private Steering Committee was formed in the United States to develop a model for dose-response analyses for formaldehyde that takes into account as much of the biological database on formaldehyde as possible. This partnership involved primarily the CIIT and the U.S. EPA. Toxicology Excellence for Risk Assessment, commissioned by the Formaldehyde Epidemiology, Toxicology, and Environmental Group, Inc., also participated, preparing sections of draft documentation related to hazard assessment. Health Canada joined this partnership later, contributing by organizing, in collaboration with the U.S. EPA, an external peer review workshop and revising some sections of the draft documentation related to hazard assessment (in particular, those addressing epidemiological data).

The product of this joint effort was a draft document entitled "Formaldehyde: Hazard Characterization and Dose-Response Assessment for Carcinogenicity by the Route of Inhalation" (CIIT, 1999). This report, which was developed primarily by CIIT (with input from J. Overton, U.S. EPA), was reviewed at an external peer review workshop of the following invitees, convened by Health Canada and the U.S. EPA on March 18-20, 1998, in Ottawa, Ontario (Health Canada, 1998):

• B. Allen, RAS Associates
• M. Andersen, ICF Kaiser Engineering (Chair)
• D. Blakey, Health Canada
• A. Dahl, Lovelace Respiratory Research Institute
• D. Gaylor, U.S. Food and Drug Administration
• J. Harkema, Michigan State University
• D. Jacobson-Kram, MA BioServices
• D. Krewski, Health Canada
• R. Maronpot, National Institute of Environmental Health Sciences
• G. Marsh, University of Pittsburgh
• J. Siemiatycki, Institut Armand-Frappier
• J. Ultman, Pennsylvania State University

Written comments were also provided by S. Moolgavkar (Fred Hutchinson Cancer Research Center).

Following the workshop, the report was revised to reflect comments of the external reviewers and recirculated; written comments on the subsequently revised draft were submitted by all members of the external review panel (November 1998). The final draft (dated September 28, 1999) (CIIT, 1999) was reviewed by the Chair of the workshop (M. Andersen) to ensure that comments had been adequately addressed (Andersen, 1999).

In this assessment, the outcome of this collaborative exercise and additional data on non-cancer effects and routes of exposure other than ingestion have been considered in the context of the approach to assessment of "toxic" under Paragraph 64(c) of CEPA 1999.

R. Vincent, Environmental Toxicology Division, Health Canada, provided comments on the Assessment Report. Accuracy of reporting, adequacy of coverage and defensibility of conclusions with respect to hazard characterization and dose-response analyses were considered in written review by M. Andersen (Colorado State University), V. Feron, (TNO-Nutrition and Food Research Institute) and J. Swenberg (University of North Carolina).

The health-related sections of the Assessment Report were reviewed and approved by the Healthy Environments and Consumer Safety Branch Risk Management meeting of Health Canada.

The entire Assessment Report was reviewed and approved by the Environment Canada/Health Canada CEPA Management Committee.

A draft of the Assessment Report was made available for a 60-day public comment period (July 22 to September 20, 2000) (Environment Canada and Health Canada, 2000). Following consideration of comments received, the Assessment Report was revised as appropriate. A summary of the comments and responses is available on the Internet at:

www.ec.gc.ca/cceb1/eng/final/index_e.html

The text of the Assessment Report has been structured to address environmental effects initially (relevant to determination of "toxic" under Paragraphs 64(a) and (b)), followed by effects on human health (relevant to determination of "toxic" under Paragraph 64(c)).

Copies of this Assessment Report are available upon request from:

• Inquiry Centre
  Environment Canada
  Main Floor, Place Vincent Massey
  351 St. Joseph Blvd.
  Hull, Quebec
  K1A 0H3

or on the Internet at: www.ec.gc.ca/cceb1/en g/final/index_e.html

Unpublished supporting documentation on the environmental assessment (Environment Canada, 1999a) or health assessment (BCH, 1988; Health Canada, 1998, 1999, 2000; Andersen, 1999; CIIT, 1999), which presents additional information, is available upon request from:

• Commercial Chemicals Evaluation Branch
  Environment Canada
  14th Floor, Place Vincent Massey
  351 St. Joseph Blvd.
  Hull, Quebec
  K1A 0H3

or

• Environmental Health Centre
  Room 104
  Health Canada
  Tunney's Pasture
  Ottawa, Ontario
  K1A 0L2