Consultation document on octamethylcyclotetrasiloxane(D4): chapter 5

5. Proposed Regulations

These regulatory proposals aim at preventing or reducing releases to the environment from industrial effluents and from the use of certain consumer products containing D4. 

The proposed regulations would be made under section 93 of CEPA 1999. Section 93 provides the authority to develop regulations with respect to a substance specified on the List of Toxic Substances in Schedule 1, including regulations regarding concentration limits, and requirements for sampling, analyses, record keeping, administration, and information submissions.

5.1 Products Regulations

5.1.1 Determination of Product Categories

Based on data received from industry, approximately 87% of D4 was used both in final products for the cosmetic and toiletry industry and in the manufacture of silicone polymers destined for the cosmetic and toiletry industry. The second most significant use of D4 at 11% was in the manufacture of silicone polymers for the coatings, sealants, and adhesives industry. The remaining 2% of D4 use was in final products from sectors including automotive, pharmaceuticals, paints, coatings, cleaning and rubber.

Analysis of the data indicates that the most significant releases to the aquatic environment were related to the use of cosmetics and toiletries. While there are numerous types of personal care products containing D4, the focus of this risk management activity is on those with the potential to result in releases to the aquatic environment. Therefore, personal care product categories were classified into three groups:

1. those with high potential for direct release to water,
2. those with moderate potential for release to water, and
3. those that are unlikely to result in releases to water.

Factors that were considered when classifying a product into one of the three groups were the volatility rate of D4 as a pure substance, the average concentration of D4 in the product, the purpose of the product, where and when the product is normally applied to the body, and how long the product is likely to be left on before it is washed off. A conservative factor of two was applied to the published volatility rates (Berthiaume 1999) of 100% volatilization in approximately 30 minutes for D4 as a pure substance. The factor was applied because published information regarding the volatility rate of D4 in finished products is not available at this time. Preliminary indications from laboratory testing performed by Environment Canada are consistent  with this assumption.

The proposed products regulations would establish concentration limits on personal care products that are considered to have a high potential for direct releases to water, and those with moderate potential for release to water.

The consultation will discuss the feasibility of the regulatory proposal, described in detail below, which has been developed with requirements that are generally consistent with other existing consumer product regulations under CEPA 1999.

5.1.2 Interpretation and Definitions

5.1.2.1 Definitions

Terms used in the cosmetic industry for various products will not be defined unless otherwise specified in the Table under Section 5.1.3 of this document, where it is necessary to clarify category groupings.

5.1.2.2 Application

The proposed concentration limits would apply to any person who manufactures, imports, sells or offers for sale products for use in Canada as outlined in the Table in Section 5.1.3. Products that are manufactured or imported for export only would be proposed to be exempt from this regulation.

5.1.2.3 Prohibition

No person would be allowed to manufacture, import, sell or offer for sale products outlined in Section 5.1.3 that are for use in Canada if the concentration of D4 exceeds the limit stipulated in the Table in Section 5.1.3.

5.1.3 Proposed Concentration Limits

Concentration limits to be proposed for D4 are included in the table below. An explanation of how these limits were derived is included in Section 5.1.3.1.

A product that may fall into multiple product categories must meet the most restrictive D4 concentration limit, as applicable.

5.1.3.1 Determination of Concentration Limits

This section describes the methodology used to determine the proposed concentrations limits that are listed in Table 1.

Criteria for Reduction:

The concentration limits have been established with the aim of meeting the Predicted No Effect Concentration (PNEC) of 0.0002 mg/L for D4 and having an aquatic Risk Quotient (RQ) of less than one. The RQ is a function of the PNEC.  A risk of adverse effects exists for aquatic organisms when the RQ is greater than one.

Step 1 - Determine Average Concentration in Various Personal Care Products

The first step in determining the concentration limits was the use of Health Canada’s Cosmetic Notification System database to group products that contain pure D4 into categories, such as hair grooming products, traditional hair conditioners, make-up removers, etc. The midpoint of the concentration range and the number of products for each range was then used to determine the average concentration for a category.

Step 2 - Determine Expected Mass (M_E) of D4 Released to Water through the use of Personal Care Products

The Mass Flow Tool, a modelling tool that tracks the mass of a substance throughout its lifecycle, was then used with data received during the Challenge to determine the potential mass of D4 being released to Canadian waters. The Mass Flow Tool accounts for the various stages of the substance, such as production losses through transfers, to air, to water in cleaning operations, or product use, exports, etc.

It is estimated that approximately 60% of personal care products containing D4 that are manufactured in Canada are exported. Products to be exported are not proposed to be subject to the regulations. This factor was therefore considered in the determination of the expected mass to be released to water.

A release of 10% to water through the use of all personal care products was also used and is based on an assumption made by the United Kingdom (Brooke 2006).

Step 3 - Determine Maximum Mass (M_M)of D4 that may be released to Water while still achieving a Risk Quotient of Less than One

The mass of D4 entering wastewater treatment plants is an input variable in the wastewater treatment plant model called Megaflush. The model contains a database of over 900 wastewater treatment sites in Canada and calculates the Predicted Effluent Concentrations and aquatic Risk Quotient of a chemical in a body of water for each site, given the mass entering Canadian waters. The model takes into account the population served, influent and effluent flow rates, type of receiving water and removal rates for various wastewater treatment processes.

The input mass was adjusted using an iterative process until the effluent concentrations resulted in no aquatic risk, meaning the Risk Quotient is less than one, for 97% of sites across Canada.

A reduction factor was calculated using the following formula:

% Reduction = (ME - M_M) / ME x 100 %

Step 4 - Reduce Average Concentration of Personal Care Products by Factor Determined in Step 3

Based on the calculations above, the average concentrations of certain personal care products that have a high or moderate potential for release of D4 to water are proposed to be reduced by 90%.

The D4 concentration limits established for the defined product categories are anticipated to manage the risks associated with the use of D4 in personal care products to a level that is acceptable for discharge at 97% of wastewater treatment sites. Of the remaining sites that did not meet a Risk Quotient of less than one, over 80% are considered to have no treatment.

5.1.4 Permitting

The proposed regulations may allow for application for a permit in situations where there is no technically or economically feasible alternative or substitute for the substance in the product.

The permit would expire two years after the day on which it is issued, unless the applicant submits an application for renewal that meets the specified requirements at least 90 days before the day on which the permit expires. The permit may be extended only once for an additional two years for a given product and the same use.

The permit would require the applicant to provide a description of a plan that identifies the measures to be taken by the applicant to minimize or eliminate any harmful effect of the toxic substance on the environment.

Any information that is submitted to the Minister under the proposed regulation is to be dated and signed by the person to whom the regulation applies or the person authorized to act on their behalf, to certify that the information is accurate and complete.

5.1.5 Labelling

Any person that manufactures, imports, sells or offers for sale products that are subject to the proposed regulations would have to indicate on the container in which the product is to be sold the date on which the product was manufactured or a code representing that date. If a code is used, the person shall provide an explanation of it to the Minister, on request.

5.1.6 Reporting Requirements

No reporting requirements are proposed.

5.1.7 Record Keeping

Any person that manufactures, imports, sells or offers for sale products that are subject to the proposed regulations would have to maintain records at their place of business in Canada, or at any other place in Canada where they can be inspected, for a period of five years. If the records are kept at any place other than the person’s principal place of business, the person must provide the Minister with the civic address of the place where they are kept. Records may be kept in electronic format. The records would contain the following information:

For manufacturers:

• trademark or trade name of the products, quantity of the products manufactured containing D4, the respective concentrations, and date of manufacture;

For importers:

• trademark or trade name of the products, quantity of the products imported containing D4, and date of import;
• port of entry, harmonized commodity description, coding system number, importer number, bill of lading, invoice, all documents submitted to Canada Border Services Agency;
• contact information and address of principal place of business of the sender of the product;

For sales to suppliers, wholesalers, or retailers:

• trademark or trade name of the products sold, quantity of the products sold containing D4, and date of sale;
• delivery date, contact information and address of supplier, wholesaler, and retailer to whom the product was sold.

5.1.8 Coming into Force

The proposed regulation would come into force one year after the day that they are registered for manufacturing and importing and two years for sale and offer for sale, to allow a sell through period.

5.2 Industrial Release Regulations

5.2.1 Application and exclusion

These proposed regulations would apply to facilities that manufacture D4 in a quantity equal to or greater than 100 kg per year or to facilities that use, process or transform D4 into a mixture or product, in a quantity of 100 kg or more.

The intent is for the regulations to apply to users and manufacturers of the pure substance, formulated products or mixtures containing the substance. The regulations would not apply to users of products containing the substance.  The intent of the proposed regulations is to exclude facilities that do not generate an effluent.

5.2.2 Prohibition of release

The proposed regulations would prohibit the release into the environment of a final effluent with a concentration exceeding the release limits. 

The proposed release limits would need to be met within one year of the coming into force of the regulations.

5.2.3 Determination of the proposed release limits from final industrial effluents

The proposed regulations would limit the release of D4 from final industrial effluents to a maximum concentration. In order to determine the proposed release limits for D4, Environment Canada has considered the factors identified in Table 2 :

One of the proposed release limits is calculated as follows:

Equation 1:

RL = (PNEC x DF) / (PF x (100% - % Removal_WWTP))

Where: 

• RL:  Release limit
• PNEC:  Predicted No-Effect Concentration
• DF:  Dilution Factor                   
• PF: Partitioning Factor
• % Removal_WWTP:  % Removal from Off-Site Wastewater Treatment Plant

Modeling applied in the screening assessment accounted for dilution of wastewater treatment plant effluents discharged into surface receiving waters.  Dilution factors were limited to a maximum value of 10 to be protective of aquatic organisms living in proximity to discharge points.  The limiting dilution factor of 10 applies to about 75% of surface waters that receive effluent from industrial facilities, with lower dilution factors applying in the balance of cases. 

Based on the Screening Assessment Report (EC & HC 2008), D4 may partition in significant quantities to air, water and sediment when released into water.  Therefore, Equation 1 takes into account that a portion of D4 released to water partitions to air.

As indicated in section 3.3.2, wastewater treatment plants can remove a certain portion of D4.  Equation 1 takes into account these removal efficiencies.  However, as secondary treatment removal rates may vary greatly (depending on the capacity and the type of treatment system) and to provide an environmental protection factor, only the removal rates of primary wastewater treatment plants were used in the calculations.

If the industrial effluent is discharged to an off-site wastewater treatment plant, the proposed D4 release limit is 5.2 ug/L and if the industrial effluent is discharged to surface water bodies, the proposed release limit is 2.3 ug/L.

5.2.4 Substance Management Plan

The proposed regulations would require facilities that are subject to these regulations to develop, implement and maintain a Substance Management Plan (SMP). The purpose of the SMP is to ensure that best management practices are adopted at facilities where D4 is used, to minimize releases to the environment.  

It is proposed that a facility will be required to develop an SMP when one result of an analysis of the final effluent determines that the concentration in the effluent is above the Method Detection Limit (MDL).  The facility will then have one year to develop an SMP, and two years to implement it. 

The SMP would include the following elements:

1. A list of factors that could increase releases of D4 in the industrial effluent. Examples of factors include type of technology, human error, accidental release, manufacturing process, type of equipment, etc.
2. Procedures to reduce the risk of release by addressing factors identified in (a).  Procedures would include method to minimize human error (such as training and standard operating procedures), inspection of critical equipment identified in (a), etc.
3. An inspection protocol to verify that the procedures in (b) control the risks efficiently.

The inspection protocol would include:

1. A list of the items to be inspected (equipment, procedure, operation, etc.);
2. Frequency of the inspection. At least one inspection per calendar year would be required;
3. Qualifications required from the person performing the inspection.

Facilities that would be required to develop an SMP would also be required to prepare an inspection report. The inspection report would include the date of the inspection, the name and qualifications of the inspector and the observations (result of the inspection).

When the inspection report reveals that a procedure in (b) does not prevent or minimize the risk associated to the factor identified in (a), a corrective action plan would need to be developed.  The corrective action plan would include a description of measures taken to remedy, reduce or mitigate the risk and a timeline to implement these measures. 

The regulations would require that the SMP be reviewed and, if necessary, updated at least once per calendar year.

5.2.5 Sampling Requirements

It is proposed that samples be taken at least four times per year, and at least 70 days apart.  The samples should be undiluted and representative of the facility industrial effluent and representative of normal operating conditions.

In order to reduce administrative burden, it is also proposed that if a facility obtain four consecutive analytical results under the method detection limit, the facility would be allowed to reduce the sampling and testing frequency to two times per year at least 120 days apart.

5.2.6 Laboratory Analysis

The proposed regulations would require that analysis of the samples be performed by a laboratory that is accredited by a Canadian accrediting body under the International Organization for Standardization standard ISO/IEC 17025: 2005 entitled General requirements for the competence of testing and calibration laboratories, as amended from time to time. 

The regulations would not specify the method to be used for analyzing samples.  However, the method used would need to meet specified analytical requirements of detection limit, precision and accuracy. This would provide flexibility in conducting analysis for laboratories, expedite the use of new analytical techniques and result in less costly approaches to conducting required testing.

The analytical methods would be required to meet a detection limit of 0.25 ug/L with an accuracy of 30% and a precision of 30%.

5.2.7 Record Keeping

It is proposed that the owner or operator of a facility would need to keep all the documents listed below at the facility to which these regulations apply or, on notification of the Minister, at any other place in Canada where they can be inspected for a period of at least five years beginning the date of their creation.

• Plan with the location of the final effluents
• Analytical results (dates, method, laboratory)
• Justification for the date of the sampling and analysis
• Substance Management Plan and information used to develop, implement and maintain the SMP
• Inspection report
• Corrective action plan
• Annual report and information used to prepare the report
• Other information required by these regulations

5.2.8  Annual Reporting

Facilities would be required to submit an annual report to the Minister that would contain the following:

• The name of the facility, the street and physical address of the facility (if different), and the telephone number and e-mail address (if applicable) of the person submitting the report;
• The quantity of the substance manufactured and/or used in the calendar year and the method used to determine this quantity;
• The estimated quantity of the substance released in the effluent during the calendar year and the method used to determine this quantity;
• The effluent flow rate and the method used to determine it.
• The dates, method and results of sampling and analysis.

The quantity of the substance released could be calculated using the measured concentration of the substance in the effluent and the effluent flow rate.  The concentration of the substance in the effluent would be determined by the sampling and analysis requirements described in sections 5.2.5 and 5.2.6.  To determine the effluent flow rate, three options can be considered: installation of a flow meter, instantaneous measurement of the effluent flow rate or estimation of the effluent flow rate based on the available information.

5.2.9 Reporting Accidental Release into the Environment

Where there occurs or is a likelihood of a release into the environment of a substance in contravention of a regulation, paragraph 95(1)(a) of CEPA 1999 requires that a written report be submitted to an enforcement officer.

The proposed regulations would require that the following information be contained in the written report:

1. the name, civic address and telephone number of the person submitting the report;
2. the civic address of the facility where the release occurred or is likely to occur;
3. in the case of a release, the date, time, duration and exact location of the release;
4. in the case of the likelihood of a release, the date, time and location where the release is likely to occur;
5. the estimated quantity of D4 that was released or may have been released;
6. a description of the circumstances leading to the release or likely release, including identification of its cause, if known, and any corrective action taken;
7. a description of measures taken to remedy, reduce or mitigate any danger from the release; and
8. the identification of all persons and agencies notified as a result of the release.

This proposed content of this report is consistent with other regulations made under CEPA 1999.

Also, in case of non-compliance with the release limits and when a written report must be submitted under section 95 of CEPA 1999, it is proposed that samples be collected and analyzed each week until the concentration of D4 in the effluent is below or equal to the proposed release limits.  When the results of three consecutive analyses determine that the concentration in the effluent is below or equal to the proposed release limits, the frequency of the sampling and analyzing would be required at the frequency indicated in section 5.2.5, i.e. at least four times per year, and at least 70 days apart.

5.2.10 Certification of information to be submitted

Any information submitted to the Minister under the proposed regulation is to be dated and signed by a person authorized to do so, to certify that the information is accurate and complete.

5.2.11 Coming into Force

The proposed regulations would come into force on the day they are registered.

The proposed release limits would need to be met within one year of the coming into force of the regulations.

It is proposed that a facilities would be required to develop an SMP, when one result of an analysis of the final effluent determines that the concentration in the effluent is above the Method Detection Limit (MDL).  The facility will then have one year to develop an SMP, and one additional year to implement it.