Canada: Report Of The Board Of Review For Siloxane D5 October 25, 2011

Last Updated: November 10 2011
Article by Harry Dahme

The Report to the Minister from the Siloxane D5 Board of Review was released on October 20, 2011. The Report is significant because it flows from the first substantive hearing by a Board of Review established pursuant to the Canadian Environmental Protection Act to review the nature and extent of danger to the environment posed by a chemical.  Siloxane D5 had been proposed to be added to Schedule 1 of the Canadian Environmental Protection Act following the completion of a Screening Assessment conducted by Environment Canada and Health Canada as part of Canada's Chemical Management Plan.  Gowling Lafleur Henderson LLP represented the Silicones Environmental, Health and Safety Council of North America before the Board of Review.

Background

Siloxane D5 is a odourless, colourless liquid that has many consumer and industrial applications. It is used as an ingredient in a number of personal care products, including deodorants, antiperspirants, cosmetics, shampoos and body lotions. It is also used as a dry cleaning solvent and in industrial cleaning.

Pursuant to Section 74 of the Canadian Environmental Protection Act, 1999 ("CEPA 1999"), the Ministers of the Environment and of Health conducted a Screening Assessment of D5. During the categorization process, D5 had been identified as a high priority for a Screening Assessment on the basis that it met the ecological categorization criteria for persistence, bio-accumulation potential and inherent toxicity to non-human organisms, and that it was known to be in commerce in Canada. The Screening Assessment concluded that, based upon the available information on its potential to cause ecological harm, D5 was considered to be entering the environment in a quantity or concentration or under conditions that has or may have an immediate or long-term harmful effect on the environment or its biological diversity. On that basis it was concluded that D5 met one or more of the criteria of Section 64 of CEPA 1999.

A Notice of Objection was filed with supporting information objecting to the conclusion reached in the Screening Assessment and a request was made to establish a Board of Review pursuant to Section 77(8) of CEPA 1999. Based upon the new scientific data provided, the Minister of the Environment agreed that a further inquiry into the nature and extent of the danger posed by D5 was warranted and accordingly established the Board of Review.

Report of the Board of Review

The Board considered all available information about the intrinsic physical and chemical properties of D5, along with its toxicity, uses, exposures and effects.  Based upon the evidence, the Board  concluded that:

  • D5 does not pose a danger to the environment;
  • while D5 may exceed the regulatory threshold for persistence it does not exceed the thresholds established in the Persistence and Bioaccumulation Regulation;
  • D5 does not bio-magnify, although it may bio-accumulate, and
  • there is no evidence to identify that D5 is toxic to any organism tested up to the limit of solubility in any environmental matrix.

Procedural Matters

The Report of the Board of Review summarizes a number of relevant procedural matters to be considered in the event of the establishment of any future Board of Review. These are:

  • the mandate of the Board may be constrained to only consider the extent of danger to the environment, and not human health as a consequence of the decision of the Minister establishing such a Board of Review;
  • the hearing before the Board is a de novo assessment of the available science;
  • the Board's review is not an appeal per se of the Screening Assessment; and
  • there is to be a full exchange of available information prior to commencement of the hearing. In addition to filing of all pertinent scientific data and reports, there was an opportunity to submit interrogatories and file supplementary data and reports in response to interrogatories. In addition, witness statements providing a summary of the evidence to be given by the witness were required to be provided.  As stated in the Report, "as a result before the hearing began, parties and the Board had a comprehensive and extensive record relating to Siloxane D5".

Legislation and Regulations

The mandate of the Board was to determine the scope and extent of the danger to the environment posed by D5. The Board concluded that its mandate was not to conduct an appeal of the Screening Assessment, recognizing that the Board should not ignore the analysis and conclusions expressed in the Screening Assessment. The Board concluded that its mandate did not include a determination on whether D5 was "CEPA-Toxic" according to Section 64 nor whether it should or should not be added to Schedule 1 to CEPA as a toxic substance.

In considering however the nature and extent of the danger posed by D5, the Board interpreted its mandate to mean that it was required to determine whether detrimental effects were caused or might be caused to the environment by D5 taking into account all of the available, relevant, scientific information about D5. Importantly the Board concluded that it was required to take into account "information about the "intrinsic" physical and chemical properties of the substance along with its uses, releases, dissipation, transformation, and degradation, pathways of exposures, toxicity and effects."  Further, the Board concluded that its review should be rooted in real-world terms and should not be a hypothetical assessment based on worst-case scenarios, insofar as the available data did not warrant that manner of proceeding.

The Persistent and Bioaccumulation Regulations were considered by the Board. A critical question addressed by the Board was the extent to which the intrinsic properties of the substance should be considered in assessment of persistence and bioaccumulation. Should the Regulations be interpreted to mean that the intrinsic properties of a substance should only be taken into account in cases where it is not possible to rely on the generally recognized methods of the OECD or other similar organizations when assessing persistence and bioaccumulation? The Board determined that:

"when assessing persistence and bioaccumulations evaluators should take into account the other factors referred to in section 5: the intrinsic properties of a chemical, the ecosystem under consideration, and conditions in the environment. Furthermore, the Board interpreted the term "intrinsic properties" to mean intensive properties such as vapour pressures and solubility as well as extensive properties such as toxicity."

On the issue of bioaccumulation the Board decided that the determination of whether a substance is bio-accumulative is not based solely on the bioaccumulation factor ("BAF"), the bio-concentration factor ("BCF") or the logarithm of its octanol-water partition coefficient ("Kow"), but may take into account other measures of bioaccumulation such as the bio-magnification factor ("BMF"), tropic magnification factor ("TMF") and fugacity. In other words, the values of BAF, BCF or Kow may be used to screen chemicals out from further consideration or to prioritize chemicals for further study but should not be used to determine whether the chemical itself will pose a danger. Rather the Regulations require consideration of the intrinsic properties of the substance as well as other aspects of bioaccumulation.

Last, with respect to the application of the "precautionary principle", the Board determined that the degree to which this principle should be applied depends upon the credibility and trustworthiness of scientific information about the substance.  If there is sufficient credible and trustworthy scientific information to conduct a scientifically robust and meaningful risk assessment then the Board concluded that it did not need to rely solely on the precautionary approach.

Nature, Use, Distribution, Concentrations and Toxicity of D5

Some observations taken from the Report of the Board which may be relevant for the purpose of assessing other substances are set out below.

  • Environment Canada regularly uses models to estimate releases to the environment, as well as the fate and distribution of a substance after release. The Board concluded that these models and tools have limitations and inaccuracies and consequently the interpretations based on the models were of limited use. Where empirical monitoring data is available, greater weight was given to measured values and the estimates provided by the models.
  • Long range transport by itself is an insufficient basis upon which to conclude a substance may pose a danger to the environment. In the case of D5 notwithstanding that D5 can be transported relatively long distances, depositions to soil or water are limited.
  • It is inappropriate to determine that a substances poses danger to the environment based on data from an extreme worst-case scenario, not representative of the concentrations released into the environment in other locations in Canada.
  • Persistence is not necessarily an indicator of danger in and of itself.
  • The Board followed a heirarchical evaluation of bioaccumulation. The Board considered the evidence of BAF and concluded that the values for BAF were equivocal and did not support a conclusion that the regulatory threshold for BAF had been met. The Board considered alternative methods of expressing bio-accumulation including multi-media BAF ("mmBAF") but concluded that it would not be appropriate to rely on either mmBAF or relative BAF. BCF is the second factor to be considered and the Board concluded that the values for BCF were equivocal . The Board went on to consider the biota-sediment accumulation factor ("BSAF"), the BMF and TMF and based upon a review of all of the data, including depuration rates concluded that D5 does not bio-magnify, notwithstanding that it can be accumulated from environmental matrices or food into organisms. Accordingly, the Board rejected the conclusion in the Screening Assessment that D5 should be classed a bio-accumulative simply by comparing the values of BAF and/or BCF to the threshold values in the Regulations. The Board concluded that such an approach may be appropriate in a lower – tiered screening assessment and in the absence of additional information of that intrinsic properties of a substance, but that where there is robust information then a more refined assessment of the potential danger should be conducted.
  • The Board concluded that adverse effects from D5 are only observed in very large concentrations, in excess of solubility limits for the various environmental matrices, which cannot be obtained in the environment as a result of normal release.
  • The Screening Assessment calculated Hazard Quotations for D5. In the Board's opinion, the Hazard Quotations were based on incorrect assumptions and parameters used to predict concentrations in the event resulting in a overly conservative estimate of the risk of D5. The Board rejected that over estimate.
  • The Board prepared probability plots for the purpose of determining danger to plants or animals and concluded that the risks were minimal.

Observations and Recommendations

The Board also made a number of observations and recommendations. These include the following:

  • The Persistence and Bioaccumulation Regulations should be reviewed periodically to ensure that they reflect current scientific standards and risk assessment methodologies.
  • A guidance document should be issued to describe how parameters such as persistence, bioaccumulation and intrinsic properties are to be examined in the risk assessment.
  • The Board encouraged Environment Canada to update its models or tools regularly, to seek outside input to ensure the integrity of those models and to ensure that users are aware of the strengths and weaknesses of the models or tools. The Board recommended that the models become transparent.

Conclusion and Summary

The Board concluded that D5 did not present a risk to the environment. While the Report of the Board may be considered as being restricted to D5, it is useful for the purposes of determining how other substances should be evaluated, how the applicable Regulations should be interpreted, and the kind of information that will be required in the event that there is any dispute with the conclusions reached in a Screening Assessment.

In order to review the Report please see:
http://www.ec.gc.ca/lcpe-cepa/6E52AE02-5E01-48B0-86DE-0C366ACC863F/CdR-BoR-D5_eng.pdf

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions