Canada has just become the first country in the world to regulate bisphenol A(BPA) as a toxic substance, adopting a precautionary approach and recognizing that the compound may be harmful to human and environmental health.
An overview of BPA regulation
By Order on October 13, the federal government added BPA to the list of toxic substances in Schedule 1 of the Canadian Environmental Protection Act, 1999.[i] The chemical name is Phenol, 4,4? -(1-methylethylidene)bis-, molecular formula C15H16O2. This is the first step in developing regulations or risk management instruments (e.g., guidelines, codes of practice) under CEPA to manage the health and environmental risks of BPA.
The Regulatory Impact Statement that accompanies the Order provides a good background on the federal Chemicals Management Plan, and includes interesting information about BPA, such as:
- · Under anerobic conditions, BPA is relatively stable; this is one factor that could lead to increased BPA levels in the environment;
- · BPA can accumulate in tissues to some extent;
- · BPA is acutely toxic to organisms in the aquatic environment; it may permanently alter hormonal, developmental or reproductive capacity for some;
- · The European Chemicals Bureau classifies BPA as a Category 3 reproductive toxicant: there are concerns for human fertility based on animal data;
- · Given that data indicate that pregnant women, fetuses and infants are potentially sensitive to the effects of BPA, and that animal studies suggest that the chemical may have neurodevelopmental and behavioural effects, BPA is entering the environment in a quantity or concentration or under conditions that do or may constitute a danger to human life or health.
As required by the Order, the Minister of the Environment published its Proposed Notice Requiring the Preparation and Implementation of Pollution Prevention Plans with Respect to Bisphenol A in Industrial Effluents in the October 16 Canada Gazette Part I (the “Gazette”).[ii] The comment period regarding this notice ends in 60 days, after which the Minister will publish a Final Notice in the Gazette requiring preparation and implementation of pollution prevention plans.
Those required to prepare and implement a plan are those who manufacture or use BPA (alone or in a mixture) in amounts of 100 kg or more per year, where as a result of this manufacturing/use, the effluent at the final discharge point of the facility contains BPA. This provision exempts those where the BPA-containing effluent results solely from pulp and paper de-inking activities, scientific research or laboratory testing.[iii] Details on factors to consider in preparing the plan are set out in the draft notice.[iv] For those subject to the Final Notice on the date it is published in the Gazette, these plans must be prepared and implementation begun by December 31, 2012 and fully implemented by December 31, 2016.[v] For those who become subject to the Final Notice after it is published in the Gazette, the plan must be prepared and implementation initiated within 3 months, and fully implemented within 18 months.
A helpful Risk Management Action Milestones timeline is provided by the government.[vi]
Important BPA meetings in Ottawa – November
The Food & Agriculture Organizations of the United Nations and World Health Organizations recently announced a stakeholder meeting to review the toxicological and health aspects of BPA.[vii] The meeting will be in Ottawa on November 1. An expert meeting will be held November 2-5, also in Ottawa.[viii]
Update on concerns about BPA[ix]
Estimates of just how much BPA humans are exposed to each day vary significantly. For example, based on a 2006 survey, the federal government estimates that 100,000 to 1,000,000 kg were used in Canada, and 500,000 kg were imported into the country[x]– a huge range that illustrates that we really have no idea how much BPA is being used. A US reference states that over 8 billion pounds (3.6 billion kg) of BPA are produced throughout the world every year, with over 100 tons (90 tonnes) released into the atmosphere annually.[xi]
Another confounding factor is that we simply don’t know all the ways in which humans are exposed to BPA. Previously, the model used for calculating exposure assumed that virtually all BPA exposure was via the oral route, from food and beverage containers; in fact, carbonless receipts, children’s books and cigarette filters, drinking water, sewage leachate and indoor/outdoor air may account for other sources and routes of exposure. [xii] [xiii]
A couple of very recent studies are of interest. Taylor et al examined pharmacokinetic parameters of BPA in monkeys, extrapolating these results to humans. The study results suggest that the total daily exposure to BPA in humans through multiple routes is much higher than scientists have previously predicted; the authors express concern that regulatory agencies have until now underestimated exposure level in humans.[xiv] In an analysis of more than 80 biomonitoring studies that measured BPA concentrations in human tissues and bodily fluids, Vandenberg et al[xv] noted that the general population is exposed to BPA from many sources.
There is still much controversy over the impact of BPA. For example, the European Food Safety Authority (EFSA) recently updated its advice on BPA, stating that available data do not support revisions to the current Tolerable Daily Intake of 0.05 mg/kg body weight for BPA that it set in 2006; nor did the authority find data relating to neurobehavioural toxicity of the chemical convincing (compare this against the Canadian government’s position).[xvi] A few months ago, Vandenberg et al published a study that compared the rationale of EFSA against conclusions reached by other panels.[xvii] The authors concluded that it was inappropriate for the EFSA panel to disregard more than 80 biomonitoring studies that documented significant human exposure to BPA in reaching its conclusion.
[i] Canada Gazette Part II – Order Adding a Toxic Substance to Schedule 1 to
the Canadian Environmental Protection Act, 1999 – SOR/2010-194. Vol. 144 No. 21. October 13 2010 (at 1806-1818). Available: http://www.gazette.gc.ca/rp-pr/p2/2010/2010-10-13/pdf/g2-14421.pdf
[ii] Canada Gazette Part I. October 16 2010. Proposed notice requiring the preparation and implementation of pollution prevention plans with respect to bisphenol A in
industrial effluents. Vol. 144, No. 42. October 16 2010. Supplement (59 pages) Available: http://www.gazette.gc.ca/rp-pr/p1/2010/2010-10-16/pdf/g1-14442.pdf
[iii] See s. 2 of the proposed notice.
[iv] At s. 4
[v] At ss. 5,6
[vi] Government of Canada. Chemical Substances. Risk management action milestones (bisphenol A). Available: http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-2/bisphenol-a/bpa-risk_hazard-eng.php
[vii] Health Canada. Announcement of stakeholder meeting: Project to review toxicological and health aspects of Bisphenol A. Available: http://www.hc-sc.gc.ca/fn-an/alt_formats/pdf/securit/packag-emball/bpa/bpa_sma-eng.pdf
[viii] Health Canada. FAO/WHO Expert Meeting To Review Toxicological and Health Aspects of Bisphenol A (BPA). Available: http://www.hc-sc.gc.ca/fn-an/securit/packag-emball/bpa/bpa_ann-eng.php
[ix] See our earlier blogs for more details about the health and environmental concerns regarding BPA
[x] Canada Gazette Part II – Order Adding a Toxic Substance to Schedule 1 to
the Canadian Environmental Protection Act, 1999 – SOR/2010-194. (at 1810). Available: http://www.gazette.gc.ca/rp-pr/p2/2010/2010-10-13/pdf/g2-14421.pdf
[xi] Vandenberg LN et al. Urinary, Circulating, and Tissue Biomonitoring Studies Indicate Widespread Exposure to Bisphenol A. Environ Health Perspect 2010;118:1055–1070. Available: http://ehp03.niehs.nih.gov/article/info%3Adoi%2F10.1289%2Fehp.0901716
[xii] Taylor JA et al. Similarity of Bisphenol A Pharmacokinetics in Rhesus Monkeys and Mice: Relevance for Human Exposure. Environ Health Perspect 2010 (published online 20 Sept 2010) Available: http://ehp03.niehs.nih.gov/article/fetchArticle.action?articleURI=info%3Adoi%2F10.1289%2Fehp.1002514
[xiii] Vandenberg LN et al, above
[xiv] Taylor JA et al, above
[xv] Vandenberg LN et al, above
[xvi] European Food Safety Authority. EFSA updates advice on bisphenol A. September 30, 2010. Available: http://www.efsa.europa.eu/en/press/news/cef100930.htm
[xvii] Vandenberg LN et al. Biomonitoring Studies Should Be Used by Regulatory Agencies to Assess Human Exposure Levels and Safety of Bisphenol A. Environ. Health Perspectives 2010 August;118(8):1051-1054. Available: http://ehp03.niehs.nih.gov/article/fetchArticle.action?articleURI=info%3Adoi%2F10.1289%2Fehp.0901717
by Jackie Campbell