WHAT'S NEW

On January 31, 2009, Canada released its newly completed Screening Assessment for vinyl acetate monomer (VAM) which concludes that VAM does not meet the toxicity criteria under the Canadian Environment Protection Act (CEPA). Environment Canada notes in its summary of VAM that "because exposure to vinyl acetate is expected to be low, and these levels are not considered to be harmful to human health, Canadians do not need to take any specific actions to reduce their exposure."

Canada's decision to reverse its original proposal (April 2008) was based largely on the relatively comprehensive review of the health effects data on VAM and the extensive amount of new data generated by the vinyl acetate industry on exposure to consumer products. As part of the assessment, Canada accepted the "existence of a practical threshold for carcinogenicity of vinyl acetate," which is consistent with the views established last year by the European Union (EU). The EU concluded that based on the available evidence there was no need to regulate consumer products produced from VAM based polymers.

Click here for the Vinyl Acetate Council's full statement on Canada's decision.

BACKGROUND

Vinyl acetate monomer (VAM) is one of over 200 substances being reviewed by Canada under its Chemicals Management Plan "Challenge" program. Canada has grouped substances in "batches," with a new batch released approximately every three months. Batch Two, which contains VAM, was first announced in the May 12, 2007 Canada Gazette notice, thereby triggering a mandatory reporting requirement for manufacturers, importers and users of VAM in Canada (above specified quantities). Canada also accepted additional, voluntary information from interested stakeholders.

In May 2008, Canada released its draft screening assessment for VAM based on very conservative and simplistic exposure modeling that identified several possible exposure areas of concern, including adhesives, paints and hair care products. Based on the results of its screening assessment, Canada proposed to classify VAM as "toxic" under the Canadian Environmental protection Act (CEPA). Many of Canada's concerns in the draft assessment appear to be based on incorrect information/assumptions on the amount of residual VAM in vinyl acetate polymers. The Vinyl Acetate Council (VAC) provided extensive comments and new research on the residual levels of VAM in polymers and products, exposure and toxicology. VAC strongly believed that when this information was considered, Canada would conclude that VAM is not toxic under CEPA.

Additional information on Canada's data collection and assessment activities is below.

Batch Two Reporting Requirements — 2007

Parties meeting the following conditions were required to submit the Section 71 notice to the Canadian government by September 12, 2007:

• if you manufactured or imported > 100 kg of the substance in Canada in 2006, whether alone, in a mixture, product or manufactured item; and,
• if you used of > 10,000 kg of the substance in Canada in 2006, whether alone, in a mixture, product or manufactured item, at any concentration.

Information required to be submitted included:

• quantity of VAM manufactured, processed or used; if not the pure substance, then the concentration of VAM in the product;
• use pattern for VAM;
• top five trade names; for uses, the top five trade names per use; and,
• quantity of VAM released to air/water/land and to off-site waste management facilities.

In addition to this product specific information, there was also a requirement to submit exposure information, including:

• procedures/policies in place to prevent or minimize releases to the environment or potential exposure to individuals in Canada;
• studies/data that measure the effect of those procedures/policies; and,
• studies/data that measure the exposure to individuals and the environment.

Affected VAC member companies complied by individually submitting forms to Canada.

Additional Voluntary Information Accepted from Stakeholders — 2007

In addition to the mandatory reporting requirements, VAC then focused its attention on developing a VAM industry response, which was submitted to Canada on November 13, 2007, the deadline Canada established for interested stakeholders to submit additional information. As part of its response, VAC raised issue with specific information that Canada published in its draft Batch 2 VAM substance profile.

Canada Announces Screening Assessment for Vinyl Acetate — May 17, 2008

On May 17, 2008, Canada published a notice in the Canada Gazette announcing the availability of a draft Screening Assessment on VAM along with 16 other compounds. Based on the draft Screening Assessment, Canada was considering designating VAM, and most of the other substances reviewed, as "toxic" under the Canadian Environmental Protection Act (CEPA).

Canada's draft Screening Assessment on VAM concluded that there is very limited exposure and hence no concern to a large majority of the products produced from vinyl acetate based polymers. Canada identified the following end products/uses as not presenting a concern:

• flexible food packaging and other food contact applications;
• pest control products;
• laminated steel;
• fuel additive;
• hydraulic and lubricant oils; and,
• chewing gum.

For a few uses, Canada identified potential concerns based on very simple exposure assessments:

• adhesives (carpet adhesive, universal wood glue, hot melt adhesives and joint sealants);
• paints and plasters; and,
• cosmetics and personal care products, including hair gel, hair spray, nail polish and eye liner.

The Vinyl Acetate Council (VAC) provided an extensive set of comments to Canada on July 16, 2008, critically reviewing the Canadian assessment. VAC worked closely with downstream users and allied organizations (Emulsion Polymers Council, National Paint & Coatings Association, The Adhesive and Sealant Council and Personal Care Products Council) in preparing the assessment and data that went into its submission to Canada. VAC has also met with Canadian authorities several times regarding the draft screening assessment and how the new data on residuals and exposure indicate that a CEPA Toxic conclusion would be inappropriate.