Priority Substances List Assessment Report for N,N-Dimethylformamide

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

DMF is used as a solvent in the production of resins and polar polymers. Applications include protective coatings, adhesives, films, printing inks, capacitors and electroplating. DMF is likely to be released from industrial and consumer uses. It does not break down easily in air. It is toxic to the liver in both humans and animals, and is possibly carcinogenic to humans. An assessment is required to evaluate whether it poses a risk to human health and the environment in Canada.

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 atwww.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, which 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 September 1999) and on human health (prior to February 2000) are presented in Appendix A. Review articles were consulted where appropriate. However, all original studies that form the basis for determining whether DMF 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).

Preparation of the environmental components of the assessment was led byA. Chevrier and M. Lewis with support from H. Atkinson, K. Doe and B. Scott under the direction of P. Thompson and P. Doyle. Sections of the Assessment Report and the supporting documentation related to the environmental assessment of DMF (Environment Canada, 2000) were reviewed by the Environmental Resource Group, established by Environment Canada to support the environmental assessment:

• D. Andrews, Golder Associates Ltd.
• N. Bunce, University of Guelph
• B. Elliott, Environment Canada
• R. Gensemer, Boston University
• M. Mumtaz, Chinook Group Ltd.
• C. Nalewajko, University of Toronto
• P. Paine, Environment Canada
• J. Prinsen, Environment Canada
• N. Tremblay, Environment Canada
  
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Environmental sections of the Assessment Report and the supporting documentation were also reviewed by:

• K. Bolton, University of Toronto
• D. Hastie, York University
• S. Mabury, University of Toronto
• M. Sheppard, EcoMatters Inc.

Sections of this Assessment Report related to health and the relevant supporting documentation (Health Canada, 2000) were prepared, based, in part, on background information prepared in 1999 by BIBRA International (1999), by the following staff of Health Canada:

• R. Gomes
• G. Long
• M.E. Meek
• M. Walker

Sections of the Assessment Report and supporting documentation on genotoxicity were reviewed by D. Blakey of the Environmental and Occupational Toxicology Division of Health Canada.

In the first stage of external review, sections of the supporting documentation pertaining to human health were considered, primarily to address adequacy of coverage, by G.L. Kennedy, DuPont Haskell Laboratory for Toxicology and Industrial Medicine.

Accuracy of reporting, adequacy of coverage and defensibility of conclusions with respect to hazard characterization and dose-response analyses were considered at a panel meeting of the following members, convened by Toxicology Excellence in Risk Assessment (TERA), on February 14, 2000, in Ottawa, Ontario:

• M.S. Abdel-Rahman, University of Medicine and Dentistry of New Jersey
• Abernathy, U.S. Environmental Protection Agency
• J.P. Christopher, California Environmental Protection Agency
• J.C. Collins, Solutia, Inc.
• J.T. Colman, Syracuse Research Corporation
• Mumtaz, Agency for Toxic Substances and Disease Registry
• K.A. Poirier, TERA
• J.E. Whalen, U.S. Environmental Protection Agency

The health-related sections of the Assessment Report were reviewed and approved by the Health Protection 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 (June 3 to August 2, 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/eng/final/index_e.html

Unpublished supporting documentation, 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