Proposed Risk Management Approach
Chemical Abstracts Service Registry Number (CAS RN)
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Table of Contents
- Why we need action
- Current used and industrial sectors
- Presence in the canadian environment and exposure sources
- Overview of existing actions
- Proposed objectives
- Proposed risk management
- Consultation approach
- Next steps / Proposed timeline
1.1 Categorization and the Challenge to Industry and Other Interested Stakeholders
The Canadian Environmental Protection Act, 1999(CEPA 1999) (Canada 1999) requires the Minister of the Environment and the Minister of Health (the Ministers) to categorize substances on theDomestic Substances List (DSL). Categorization involves identifying those substances on the DSL that a) are considered to be persistent (P) and/or bioaccumulative (B), based on the criteria set out in the Persistence and Bioaccumulation Regulations, and “inherently toxic” (iT) to humans or other organisms; or b) present, to individuals in Canada, the greatest potential for exposure (GPE). In addition, the Act requires the Ministers to conduct screening assessments of substances that meet the categorization criteria. The assessment further determines whether the substance meets the definition of “toxic” set out in section 64 of CEPA 1999.
In December 2006, the Challenge identified 193 chemical substances through categorization which became high priorities for assessment due to their hazardous properties and their potential to pose risks to human health and the environment. In February 2007, the Ministers began publishing, for industry and stakeholder comment, profiles of batches containing 15 to 30 high-priority substances.
In addition, the information-gathering provisions under section 71 of CEPA 1999 are being used under the Challenge to gather specific information where it is required. The information that is collected through the Challenge will be used to make informed decisions and appropriately manage any risks that may be associated with these substances.
The substance 1-Propanol, 2-methoxy, Chemical Abstracts Service Registry Number (CAS RN)1 1589-47-5, referred to throughout this document by “2-methoxypropanol”, was included in Batch 3 of the Challenge under the Chemicals Management Plan.
1.2 Final Screening Assessment Report Conclusion for 2-Methoxypropanol
A notice summarizing the scientific considerations of a final screening assessment report was published by Environment Canada and Health Canada in the Canada Gazette,Part I, for 2-methoxypropanol on March 7, 2009, under paragraphs 68(b) and 68 (c) of CEPA 1999. The final screening assessment report concluded that 2-methoxypropanol is entering or may be entering the environment in a quantity or a concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Based upon the potential inadequacy of the margins of exposure between conservative estimates of exposure to 2-methoxypropanol during use of consumer products via inhalation and critical effect levels for developmental toxicity in experimental animals, it is concluded that 2-methoxypropanol be considered “toxic” as defined in paragraph 64(c) of CEPA 1999; i.e., as a substance that may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Based on the information presented in this draft screening assessment, it is proposed that 2-methoxypropanol is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term effect on the environment or its biological diversity, or that constitute or may constitute a danger to the environment on which life depends.
It is therefore proposed that 2-methoxypropanol does not meet the definition of “toxic” as set out in paragraphs 64(a) or 64(b) of CEPA 1999.
The final screening assessment report also concluded that 2-methoxypropanol does not meet the criteria for persistence and does not meet the criteria for bioaccumulation, as defined by thePersistence and Bioaccumulation Regulations made underCEPA 1999. The presence of 2-methoxypropanol in the environment results primarily from human activity.
For further information on the final screening assessment report conclusion for 2-methoxypropanol, refer to the final screening assessment report, available at www.chemicalsubstanceschimiques.gc.ca
1.3 Proposed Measure
Following a screening assessment of a substance under section 68 of CEPA 1999, a substance may be found to meet the criteria under section 64 of CEPA 1999. The Ministers can propose to take no further action with respect to the substance, add the substance to the Priority Substances List (PSL) for further assessment, or recommend the addition of the substance to the List of Toxic Substances in Schedule 1 of CEPA 1999. Under certain circumstances, the Ministers must make a specific proposal either to recommend addition to the List of Toxic Substances or to recommend the implementation of virtual elimination (or both). In this case, the Ministers proposed to recommend the addition of 2-methoxypropanol to the List of Toxic Substances in Schedule 1 of CEPA 1999. As a result, the Ministers will develop a regulation or instrument respecting preventive or control actions to protect the health of Canadians and the environment from the potential effects of exposure to this substance.
The final screening assessment report did not conclude that 2-methoxypropanol meets the conditions set out in subsection 77(4) of CEPA 1999. As a result, 2-methoxypropanol will not be subject to the virtual elimination provisions under CEPA 1999 and will be managed using a life-cycle approach, to prevent or minimize its release into the environment.
2.1 Substance Information
2-Methoxypropanol is part of the chemical grouping organics and the chemical sub grouping alcohols.
Table 1 presents other names, trade names, chemical groupings, the chemical formula, the chemical structure and the molecular mass for 2-methoxypropanol.
|Chemical Abstracts Service Registry Number (CAS RN)||1589-47-5|
|National Chemical Inventories(NCI) names2||1-Propanol, 2-methoxy- (TSCA);|
|Other names||2-Methoxy-1-propanol; 2-Methoxy-1-hydroxypropane; Beta-propylene glycol monomethyl ether (beta-PGME)|
|Molecular mass||90.12 g/mol|
3. Why we need action
3.1 Characterization of Risk
Based principally on the weight-of-evidence classification of 2-methoxypropanol by the European Commission as Category 2 for developmental toxicity (ESIS 2007), and on consideration of available relevant data for the substance as well as for related chemicals, the critical effect for characterization of risk to human health for 2-methoxypropanol is developmental toxicity. In addition, hematopoietic and male reproductive system effects were also observed in experimental animals. Therefore, margins of exposure are derived between lowest exposure levels associated with induction of these effects and conservative estimates of population exposure to 2-methoxypropanol.
The principal source of exposure to 2-methoxypropanol for the general population is expected to be through inhalation and dermal contact during use of consumer products containing the substance. The maximum potential indoor air concentration of 2-methoxypropanol, based on monitoring data for 1-methoxy-2-propanol collected in Germany (Schleibinger et al. 2001), and assuming that 2-methoxypropanol is co-present with 1-methoxy-2-propanol in indoor air at a maximum ratio of 5:95, was 135 mg/m3. Modelling-based estimates of inhalation exposure during use of cosmetic or paint products resulted in much higher indoor air concentrations. The conservative upper-bounding estimate of airborne concentration is 52 mg/m3 from use of paint remover. Comparison between the critical lowest-observed-effect concentration (LOEC) of 843 mg/m3 for developmental effects observed in experimental animals (Hellwig et al. 1994) and the estimated maximum indoor air concentration of 135 μg/m3 results in a large margin of exposure of approximately 6200. However, the margins of exposure to 2-methoxypropanol in air during use of consumer products containing the substance are smaller (e.g., as low as 16 for one type of paint remover). The margins of exposure would be further reduced when multiple products were used within a short period of time (e.g., nail polish remover and nail enamel applied in one day). Thus, the margins for inhalation exposure during use of consumer products (such as paint remover, some personal care products, concrete floor primer, polyurethane varnish) may not be adequately protective to human health in light of the uncertainties in the databases and the serious nature of the health effects associated with exposure to this substance (i.e., developmental toxicity).
Dermal contact also contributes significantly to exposure to 2-methoxypropanol during use of products containing the substance, with the highest predicted acute dermal dose of 2820 μg/kg-bw/day from hair dye. However, no adequate dermal toxicity study has been identified for 2-methoxypropanol to provide a basis for dose-response analysis for comparison with this estimated exposure. (Although one study involving dermal exposure to 2-methoxypropanol acetate was available, due to differences in skin permeability of the two substances (Larese Filon et al. 1999), it is not considered appropriate to extrapolate the results of this study to quantify hazard for 2-methoxypropanol.) Therefore, insufficient information is available to characterize risk to health associated with dermal exposure to 2-methoxypropanol from consumer products (Canada 2009).
4. Current used and industrial sectors
2-Methoxypropanol is not produced intentionally; it is a by-product in the manufacture of commercial propylene glycol monomethyl ether (PGME), and can be found as an impurity in PGME at concentrations of up to 5% (Verschueren 2001). The main component of PGME is the alpha isomer, 1-methoxy-2-propanol, CAS number 107-98-2. According to data submitted under section 71 ofCEPA 1999, 2-methoxypropanol was not manufactured in Canada in 2006 above the reporting threshold of 100 kg. The total quantity imported into Canada in the same calendar year was reported to be in the range of 10 000–100 000 kg (Environment Canada 2008).
2-Methoxypropanol may be present as an impurity in nail enamel, nail polish remover, hair conditioner, hair dye, hair spray and false eyelash adhesive as well as in a solvent to remove false eyelashes, as these products were identified as containing PGME (report received from Health Canada, Product Safety Programme, Cosmetics Division, sent to Health Canada, Existing Substances Bureau, unreferenced; CNS 2008). 2-Methoxypropanol is not intentionally added to pest control products in Canada but may be present as an impurity in the formulant PGME (e-mail 2008 from Health Canada, Pest Management and Regulatory Agency sent to Health Canada, Existing Substances Bureau, unreferenced). 2-ethoxypropanol may be present as an impurity in solvents used in the manufacture of inks, lined varnishes and coatings (interior and exterior) in paperboard and plastic food packaging applications; however, the solvents are not expected to be present in the finished food packaging materials. PGME is used in the compositions of cleaners, which require rinsing of treated surfaces with potable water in food plants. PGME is also an intermediate substance in the production of propylene glycol monomethyl ether acetate (PMA), and may contain 2-methoxypropanol as an impurity. PMA is used as a solvent in the manufacture of epoxy resins that are used as coatings on the interior of railway hopper cars, farm storage bins and truck trailers to store or transport dry food products. PGME and PMA are also used as solvents in the formulations of products applied on non-food contact surfaces, which must be used under well-ventilated conditions where there will be no accumulation of solvent vapours in food processing areas. Human exposures to 2-methoxypropanol from these food-packaging-related uses are considered to be negligible (2008 and 2009 e-mails from Food Packaging Materials and Incidental Additives Section, Food Directorate, Health Canada, to Existing Substances Bureau, Health Canada; unreferenced).
Other uses of PGME, the substance in which 2-methoxypropanol is present as an impurity, in Canada or in other countries, include as a chemical intermediate in the manufacture of propylene glycol methyl ether acetate; as a solvent in surface coatings, varnishes, paints and agricultural pesticides (OECD 2001; Imperial 2004); and as a solvent and/or coupling agent in various types of inks and cleaners (including automotive cleaners, window and oven cleaners, carpet and upholstery cleaners, rust removers and hard surface cleaners) (OECD 2001; 3M 2002; Noveon 2006a,b,c; Dow 2004). 2-Methoxypropanol may also be found at a low concentration (< 5%) in other PGME-containing products including adhesives, electronics, non-structural caulking compounds and sealants, synthetic resins and rubber adhesives (OECD 2001; Imperial 2004), plaster (HPD 2007), paint stripper, concrete floor primer, polyurethane varnish, wallpaper remover, spot remover, and kitchen and bath wipes (HPD 2008). It may also be found in products used for surface treatments, wood protection, waterproofing, shoes and leather, metals, and the galvano technique, as well as in photographic chemicals, hydraulic brake fluids and lubricants, disinfectants, pickling solutions, and perfumes (Dentan et al. 2000; Canada 2009).
5. Presence in the canadian environment and exposure sources
5.1 Releases to the Environment
According to information reported under section 71 ofCEPA 1999, less than 100 kg of 2-methoxypropanol were released to the environment in 2006, mainly to air (Environment Canada 2008). Releases of 2-methoxypropanol were not reported to the National Pollutant Release Inventory (NPRI 2006) or to the U.S. Toxics Release Inventory (TRI 2006).
5.2 Exposure Sources
No data were identified on concentrations of 2-methoxypropanol in environmental media in Canada or elsewhere. Modelled predictions of concentrations of 2-methoxypropanol in environmental media, based on the industrial releases reported under section 71 of CEPA 1999 (Environment Canada 2008), were very low and population exposure is, therefore, expected to be negligible. Concentrations of 2-methoxypropanol in food and beverages are not expected to be significant, based on available information on uses as well as physical and chemical properties, and since the potential for 2-methoxypropanol to bioaccumulate is low. Based on European studies (De Bortoli et al. 1986; Plieninger and Marchl 1999; Schleibinger et al. 2001) and taking into account that there may be up to 5% 2-methoxypropanol in PGME (Verschueren 2001), the maximum potential concentration of 2-methoxypropanol in indoor air may be up to 135 mg/m3.
2-Methoxypropanol may be present as an impurity in the following consumer products that contain PGME: nail enamel, nail polish remover, hair conditioner, hair spray, hair dye, and false eyelash adhesive and remover (CNS 2008), as well as in aerosol paint and exterior stains (Environment Canada 2008), paint remover, spray stain remover, concrete floor primer and polyurethane varnish (HPD 2008). Modelling was conducted to estimate inhalation and dermal exposures to 2-methoxypropanol during use of these products. Predicted airborne concentrations during use of various consumer products ranged from 0.01 to 51 700 µg/m3. The highest predicted airborne concentration was from use of paint remover (solvent-based), assuming a concentration of 0.26% 2-methoxypropanol (based on a maximum concentration of 13% PGME in paint remover containing 2% 2-methoxypropanol as an impurity) (J.T. Baker 2006; Grainger 2006). Airborne concentrations from use of paint remover (water-based), concrete floor primer, polyurethane varnish (applied to floors), nail polish remover and nail enamel were greater than 1000 µg/m3. The predicted airborne concentrations resulting from use of these products indoors range from less than 0.1 to 12 900 µg/m3 and less than 0.1 to 129 000 µg/m3 if PGME contained 0.5% and 5% 2-methoxypropanol respectively. The predicted concentration in air was not estimated for external stains, as weather conditions--which can be highly variable and affect ventilation rate as well as temperature--and an undefined room volume (infinitely large) prevent the estimation of reasonable outdoor inhalation exposure scenarios (RIVM 2007).
Dermal contact with 2-methoxypropanol, found as an impurity in PGME-containing products, could significantly contribute to overall exposures to this substance, as data indicate that PGME can be readily absorbed through human skin in vitro (Larese Filon et al. 1999). Estimated dermal exposures for products used infrequently (paint remover, concrete floor primer, polyurethane varnish, aerosol paint, exterior stain) ranged from 0.03 to 59 µg/kg body weight (kg-bw) per event, whereas estimated dermal exposures from personal care products and spray spot remover ranged from 3.1 to 2820 µg/kg-bw per day as an acute dose per event and from 1 to 77 µg/kg-bw per day if amortized to chronic exposures for products used more frequently. The highest predicted dermal exposure was from use of hair dye, which assumed a concentration of 0.2% 2-methoxypropanol (based on a maximum concentration of 10% PGME in hair dye containing 2% 2-methoxypropanol as an impurity) (J.T. Baker 2006; CNS 2008). The estimated dermal exposures would range between 0.008 and 705 µg/kg-bw per event and between 0.08 and 7050 µg/kg-bw per event if PGME contained 0.5% and 5% 2-methoxypropanol respectively.
1-Methoxy-2-propanol has been identified in emissions from new computer monitors at 13 µg/unit per hour after 7 h of operation. No emissions were measured after 9 days of operation (Danish Technological Institute 2003). 2-Methoxypropanol was not measured in this study.
The margins for inhalation exposure during use of consumer products including paint remover, concrete floor primer, polyurethane varnish and certain personal care products (particularly nail enamel and nail polish remover) may not be adequately protective of human health. In addition, insufficient information is available to quantify the risk to health associated with dermal exposure to 2-methoxypropanol from consumer products.
6. Overview of existing actions
6.1 Existing Canadian Risk Management
2-Methoxypropanol is subject to
- the Pest Control Products Act (Canada 2002)
2-Methoxypropanol is also impacted by the proposed Volatile Organic Compound (VOC) Concentration Limits for Certain Products Regulations (Canada 2008).
6.2 Existing International Risk Management
- EC Directive 2004/93/EC amending Directive 76/768/EEC specifically prohibits the use of 2-methoxypropanol in cosmetics (EC 1976a).
- 2-Methoxypropanol may not be used in substances and preparations placed on the market for sale to the general public at concentrations of equal to or greater than 0.5%, according to Directive 76/769/EEC and Directive 88/379/EEC (EC 1976b; EC 1988; de Kettenis 2005).
- All products containing equal to or greater than 0.5% 2-methoxypropanol require labelling as reproductive toxicants, according to EC Statutory Instrument 2008 No. 2337, the Chemicals (Hazard Information and Packaging for Supply) (Amendment) Regulations 2008 (EC 2008).
- 2-Methoxypropanol is a Phase-Out Substance in Sweden (KEMI 2007)
- 2-Methoxypropanol is on the “List of Undesirable Substances 2004” published by the Danish Environmental Protection Agency (Danish EPA 2004)
- 2-Methoxypropanol is on the “Restricted Substances List” of Levi Strauss & Co., with a limit value in the final product of 1000 mg/kg (Levi Strauss & Co. 2006)
- As a volatile organic compound (VOC), 2-methoxypropanol may be subject to the US EPA National Volatile Organic Compound Emission Standards for Consumer Products under theClean Air Act (CAA) (US EPA 1998); the Ozone Transport Commission Model Rule (OTC 2006a,b); and the California Air Resources Board regulations prescribing VOC content limits for antiperspirants, deodorants and consumer products (ARB 2008).
7.1 Alternative Chemicals or Substitutes
2-Methoxypropanol is produced unintentionally and is an unwanted contaminant in PGME (propylene glycol monomethyl ether). Therefore reducing exposure to 2-methoxypropanol may be more a question of reducing its presence as a residual in PGME than of finding a substitute (see section 7.2, Alternative Technologies and/or Techniques). With regard to substitutes for PGME, the Canadian Paint and Coatings Association provided information to the effect that other dispersants are available but at a higher cost. PGME can be substituted with other alcohols in industrial coatings but their solubility characteristics are not as good. Furthermore, there are no substitutes for PGME in drier coatings.
7.2 Alternative Technologies and/or Techniques
Industrial technologies to reduce the quantities of 2-methoxypropanol in PGME exist. 2-Methoxypropanol is only permitted at concentrations of 0.5% or less in substances and preparations placed on the market for sale to the general public in the European Union, according to Directive 76/769/EEC and Directive 88/379/EEC (EC 1976b; EC 1988; de Kettenis 2005). Therefore these levels are technologically feasible.
7.3 Socio-economic Considerations
Socio-economic factors will be considered in the development of regulations, instrument(s) and/or tool(s) as identified in theCabinet Directive on Streamlining Regulation (Treasury Board of Canada Secretariat 2007) and the guidance provided in the Treasury Board document Assessing, Selecting, and Implementing Instruments for Government Action.
Socio-economic considerations for 2-methoxypropanol include:
- 2-Methoxypropanol was not manufactured above the threshold of 100kg/yr in 2006 in Canada, and the total quantity imported into Canada in 2006 was in the range of 10 000–100 000 kg.
- 2-Methoxypropanol may be present as an impurity, and the industry sectors to which importers, formulators and users of the substance belong may include but are not limited to Toilet Preparation Manufacturing (NAICS325620) and Paint and Coating Manufacturing (NAICS325510).
- 2-Methoxypropanol may be present as an impurity in nail enamel, nail polish remover, hair conditioner, hair dye, hair spray and false eyelash adhesive as well as in a solvent to remove false eyelashes. These products are included in the Toilet Preparation Manufacturing industry (NAICS325620). The revenue of this industry was $1.8 billion in 2006, with 285 establishments employing approximately 5700 employees (Statistics Canada 2008).
- Canadian annual exports for Toilet Preparation Manufacturing products increased from $504 million in 1997 to $1.3 billion in 2007. During the same period, Canadian annual imports rose from $948 million to $1.8 billion (Industry Canada 2008).
- 2-Methoxypropanol may be present as an impurity in varnish, paint stripper and concrete primer. These products are included in the Paints and Coating Manufacturing Industry (NAICS325510). The revenue of this industry was approximately $2 billion in 2006, with 273 establishments employing approximately 6100 employees (Statistics Canada 2008).
- Canadian annual exports for Paint and Coating Manufacturing products increased from $302 million in 1997 to $454 million in 2007. During the same period, Canadian annual imports rose from $705 million to $956 million (Industry Canada 2008).
- 2-Methoxypropanol is an impurity in propylene glycol methyl ether beta isomer (PGME) and technologically feasible industrial technologies exist to reduce quantities of 2-methoxypropanol in PGME.
7.4 Children's Exposure
The Government of Canada considered, where available, risk assessment information relevant to children’s exposure to this substance. As part of the Challenge, the Government asked industry and interested stakeholders to submit any information on the substance that may be used to inform risk assessment, risk management and product stewardship. In particular, stakeholders were asked through a questionnaire if any of the products containing the substance were intended for use by children. Given the information received, it is proposed that no risk management actions to specifically protect children are required for this substance at this time.
8. Proposed objectives
8.1 Human Health Objective
An environmental or human health objective is a quantitative or qualitative statement of what should be achieved to address environmental or human health concerns identified during a risk assessment.
The proposed human health objective for 2-methoxypropanol is to reduce exposure of the general population to 2-methoxypropanol to levels that are adequately protective of human health.
8.2 Risk Management Objective
A risk management objective is a target expected to be achieved for a given substance by the implementation of risk management regulations, instrument(s) and/or tool(s). The proposed risk management objective for 2-methoxypropanol is to ensure that the concentrations of 2-methoxypropanol in cosmetics and consumer products do not exceed levels that are adequately protective of human health.
9. Proposed risk management
9.1 Proposed Risk Management Instrument
As required by the Government of Canada’s Cabinet Directive on Streamlining Regulation,3 and criteria identified in the Treasury Boarddocument entitled Assessing, Selecting, and Implementing Instruments for Government Action, the proposed risk management regulations, instrument(s) and/or tool(s) were selected using a consistent approach, and took into consideration the information that has been received through the Challenge and other information available at the time.
In order to achieve the risk management objective and to work towards achieving the environmental or human health objective(s), the risk management being considered for 2-methoxypropanol is adding 2-methoxypropanol to the Cosmetic Ingredient Hotlist and investigating whether action under the Hazardous Products Act is required with regard to consumer products.
2-Methoxypropanol may be present as an impurity in nail enamel, nail polish remover, hair conditioner, hair dye, hair spray and false eyelash adhesive as well as in a solvent to remove false eyelashes, as these products were identified as containing PGME (report received from Health Canada, Product Safety Programme, Cosmetics Division, sent to Health Canada, Existing Substances Bureau, unreferenced; CNS 2008). According to the screening assessment (Canada 2008), the margins between conservative upper-bounding estimates of airborne concentrations in the immediate vicinity of the user during use of cosmetics containing 2-methoxypropanol, and critical effect levels for developmental effects in experimental animals may not be adequately protective of human health. Therefore , the government will take action to manage 2-methoxypropanol in cosmetic products, in accordance with section 16 of the Food and Drugs Act, which states that no person shall sell a cosmetic product that has in it any substance that may injure the health of the user when the cosmetic is used according to its customary method. The government proposes to achieve this goal through addition of 2-methoxypropanol to the Health Canada Cosmetic Ingredient Hotlist, which is an administrative tool to help cosmetic manufacturers satisfy the provisions of section 16. Compliance with the provisions of section 16 are monitored, in part, through the mandatory notification provisions of section 30 of the Cosmetic Regulations of the Food and Drugs Act, which requires that all manufacturers and importers provide a list of the cosmetic’s ingredients to Health Canada. Furthermore, PGME will be prohibited from cosmetics if it contains 2-methoxypropanol concentrations of greater than 0.5%.
9.1.2 Consumer Products Including Paints and Coatings
The screening assessment indicates that the margins for inhalation exposure to certain consumer products may not be adequately protective of human health. These products include paint remover, polyurethane varnish and concrete floor primer. Health Canada will investigate whether action under the Hazardous Products Act is required with regard to these products. The initial step will involve further characterization of the exposure potential to reduce the uncertainty in the exposure estimates.
9.1.3 Food packaging
2-Methoxypropanol may be present as an impurity in solvents used in the manufacture of inks, lined varnishes and coatings (interior and exterior) in paperboard and plastic food packaging applications; however, the solvents are not expected to be present in the finished food packaging materials. PGME is used in the compositions of cleaners, which require rinsing of treated surfaces with potable water in food plants. PGME is also an intermediate substance in the production of propylene glycol monomethyl ether acetate (PMA), and may contain 2-methoxypropanol as an impurity. PMA is used as a solvent in the manufacture of epoxy resins that are used as coatings on the interior of railway hopper cars, farm storage bins and truck trailers to store or transport dry food products. PGME and PMA are also used as solvents in the formulations of products applied on non-food contact surfaces, which must be used under well-ventilated conditions where there will be no accumulation of solvent vapours in food processing areas. Human exposures to 2-methoxypropanol from these food-packaging-related uses are considered to be negligible (2008 and 2009 e-mails from Food Packaging Materials and Incidental Additives Section, Food Directorate, Health Canada, to Existing Substances Bureau, Health Canada; unreferenced). To ensure that residual levels in food packaging applications remain low, data will be requested on residual levels of 2-methoxypropanol for new food packaging submissions with direct food contact.
9.1.4 Pest control Products
2-Methoxypropanol is not intentionally added to pest control products in Canada but may be present as an impurity in the formulant PGME (e-mail 2008 from Health Canada, Pest Management and Regulatory Agency sent to Health Canada, Existing Substances Bureau, unreferenced). Concentrations of 2-methoxypropanol in pest control products are a maximum of 0.4%; this is expected to be a negligible source of human exposure, and risk management is not required.
9.2 Implementation Plan
The proposed regulation or instrument respecting preventative or control actions in relation to this substance will be published in the Canada Gazette, Part I, no later than March 2011.
10. Consultation approach
The risk management scope for 2-methoxypropanol, which summarized the proposed risk management under consideration at that time, was published on August 23, 2008, and is available atwww.chemicalsubstanceschimiques.gc.ca. Industry and other interested stakeholders were invited to submit comments on the risk management scope during a 60-day comment period. Comments received on the risk management scope document were taken into consideration in the development of this proposed risk management approach document.
Consultation for the risk management approach will involve publication on March 7, 2009, and a 60-day public comment period.
The primary stakeholders include
- the cosmetics industry and the paints and coatings industry
- non-governmental organizations
- Health Canada and Environment Canada
11. Next steps / Proposed timeline
|Electronic consultation on proposed risk management approach||March 7, 2009, to May 6, 2009|
|Response to comments on the risk management approach||At time of publication of proposed instrument|
|Consultation on the draft instrument||Summer-Fall 2009|
|Publication of the proposed instrument||No later than March 2011|
|Formal public comment period on the proposed instrument||No later than spring 2011|
|Publication of the final instrument||No later than September 2012|
Industry and other interested stakeholders are invited to submit comments on the content of this proposed risk management approach or provide other information that would help to inform decision making. Please submit comments prior to May 6, 2009, since the Government of Canada will be moving forward with the risk management of 2-methoxypropanol after this date. Pursuant to section 313 of CEPA 1999, any person who provides information to the Minister of the Environment under CEPA 1999 may submit with the information a request that it be treated as confidential. During the development of regulations, instrument(s) and/or tool(s), there will be opportunity for consultation. Comments and information submissions on the proposed risk management approach should be submitted to the address provided below:
Chemicals Management Division
Gatineau QC K1A 0H3
Tel: 1-888-228-0530 / 819-956-9313
Fax: 1-800-410-4314 / 819-953-4936
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2 National Chemical Inventories (NCI) 2007:AICS(Australian Inventory of Chemical Substances), ECL (Korean Existing Chemicals List), EINECS(European Inventory of Existing Chemical Substances);ENCS(Japanese Existing and New Chemical Substances); PICCS(Philippine Inventory of Chemicals and Chemical Substances);TSCA (Toxic Substances Control Act Chemical Substances Inventory);ASIA-PAC(Combined Inventories of Asia-Pacific Region); NZIoC (The New Zealand Inventory of Chemicals).
3 Section 4.4 of the Cabinet Directive on Streamlining Regulationstates that “Departments and agencies are to: identify the appropriate instrument or mix of instruments, including regulatory and non-regulatory measures, and justify their application before submitting a regulatory proposal”.
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