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Proposed Risk Management Approach for

Bromic acid, potassium salt
(Potassium bromate)

Chemical Abstracts Service Registry Number (CAS RN):
7758-01-2

Environment Canada
Health Canada

September 2010


(PDF version - 110 KB)

Table of Contents

  1. Issue
  2. Background
  3. Why We Need Action
  4. Current Uses and Industrial Sectors
  5. Presence in the Canadian Environment and Exposure Sources
  6. Overview of Existing Actions
  7. Considerations
  8. Proposed Objectives
  9. Proposed Risk Management
  10. Consultation Approach
  11. Next Steps / Proposed Timeline
  12. References

This proposed risk management approach document builds on the previously released risk management scope document for potassium bromate, and outlines the proposed control actions for this substance. 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. Following this consultation period, the Government of Canada will initiate the development of the specific risk management instrument(s) and/or regulation(s) where necessary. Comments received on the proposed risk management approach will be taken into consideration in developing the instrument(s) and/or regulation(s). Consultation will also take place as instrument(s) and/or regulation(s) are developed.

Summary of Proposed Risk Management

  1. The Government of Canada plans to implement Significant New Activity provisions under CEPA 1999 to potassium bromate.
  2. The Government of Canada plans to amend the Cosmetic Regulations to change potassium bromate from a substance that triggers labelling and packaging requirements to a substance that is prohibited in cosmetics. The Government of Canada also plans to update the corresponding listing for potassium bromate on Health Canada’s Cosmetic Ingredient Hotlist to reflect the amendment of the Cosmetic Regulations.

Note: This summary is an abridged list of the instruments and tools proposed to risk manage this substance. Please see section 9.1 of this document for a complete explanation of risk management.

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1. Issue

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 the Domestic Substances List (DSL). Categorization involves identifying those substances on the DSL that, in accordance with the criteria at section 73 of the Act, a) are considered to be persistent (P) or bioaccumulative (B), based on the criteria set out in the Persistence and Bioaccumulation Regulations (Canada 2000),and “inherently toxic” (iT) to humans or other organisms, or b) may 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 one or more of the criteria set out in section 64 of the Act[1].
 
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 comments, profiles of batches containing 12 to 19 high-priority substances. New batches are released for comments every three months.
 
Information-gathering authority in section 71 of CEPA 1999 is being used under the Challenge to gather specific information where it is required. The information that is collected through the Challenge is used to make informed decisions and appropriately manage any risks that may be associated with these substances.
 
The substance bromic acid, potassium salt, Chemical Abstracts Service Registry Number (CAS RN)[2]7758-01-2, referred to throughout this document as “potassium bromate”, is included in Batch 9 of the Challenge under the Chemicals Management Plan.

1.2 Final Screening Assessment Report Conclusion for Potassium Bromate

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 potassium bromate on September 18, 2010, under subsection 77(6) of CEPA 1999.

On the basis of the carcinogenic potential of potassium bromate, for which there may be a probability of harm at any exposure level, the final screening assessment report concluded that potassium bromate 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 available, the final screening assessment report also concluded that potassium bromate is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

The final screening assessment report also concluded that potassium bromate meets the criteria for persistence in water but not the criteria for bioaccumulation, as defined in thePersistence and Bioaccumulation Regulations made under CEPA 1999. The presence of potassium bromate in the environment results primarily from human activity.
 
For further information on the final screening assessment report conclusion for potassium bromate, refer to the final screening assessment report.

1.3 Proposed Measure

As a result of a screening assessment of a substance under section 74 of CEPA 1999, the substance may be found to meet one or more of 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 the Act. Under certain circumstances, the Ministers must make a specific proposal to recommend the implementation of virtual elimination. In this case, the Ministers proposed to recommend the addition of potassium bromate to the List of Toxic Substances in Schedule 1. 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.

Potassium bromate is not subject to the virtual elimination provisions under CEPA 1999 and will be managed using a lifecycle approach, to prevent or minimize human exposure to this substance. 

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2. Background

2.1 Substance Information

Potassium bromate is part of the chemical grouping, inorganics, and the chemical sub grouping, bromate-containing salts.

Table 1 presents other names, trade names, chemical groupings, the chemical formula, the chemical structure and the molecular mass for potassium bromate.

Table 1. Identity of potassium bromate

CAS RN7758-01-2
DSL NameBromic acid, potassium salt
NCI names1Bromic acid, potassium salt (1:1) (TSCA)
Bromic acid, potassium salt (AICS, ASIA-PAC, NZIoC, PICCS, SWISS)
Potassium bromate (ECL, EINECS, ENCS, PICCS)
Other namesUN 1484; UN 1484 (DOT)
Chemical group (DSL stream)Inorganics
Major chemical class or useInorganic salts
Major chemical subclassBromate-containing salts
Chemical formulaKBrO3
Chemical structure Chemical structure 7758-01-2
SMILES2Not applicable
Molecular mass167 g/mol
1 National Chemical Inventories (NCI). 2009: AICS, Australian Inventory of Chemical Substances; ASIA-PAC, Asia-Pacific Substances Lists; CAS RN, Chemical Abstracts Service Registry Number; DOT, US Department of Transport; DSL, Domestic Substances List; ECL, Korean Existing Chemicals List; EINECS, European Inventory of Existing Commercial Chemical Substances; ENCS, Japanese Existing and New Chemical Substances; NCI, National Chemical Inventories; NZIoC, New Zealand Inventory of Chemicals; PICCS, Philippine Inventory of Chemicals and Chemical Substances; SMILES, simplified molecular input line entry specification; SWISS, Swiss Giftliste 1 and Inventory of Notified New Substances; TSCA, Toxic Substances Control Act Chemical Substance Inventory. Source: NCI 2007
2 Simplified Molecular Input Line Entry System

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3. Why We Need Action

3.1 Characterization of Risk

Evaluation of risk to human health involves consideration of data relevant to estimation of exposure (non-occupational) of the general population, as well as information on health hazards.

As potassium bromate was classified on the basis of carcinogenicity by international regulatory agencies, carcinogenicity was a key focus for the screening assessment report. Kidney tumours, mesotheliomas (testes and peritoneal cavity), and thyroid tumours were observed in rats after administration of potassium bromate via drinking water. No evidence was available to suggest a carcinogenic potential for potassium bromate via the inhalation or dermal routes. Data from a wide range of genotoxicity studies suggests that potassium bromate is genotoxic in vitro and in vivo.  Although the mode of induction of tumours has not been fully elucidated, based on the genotoxicity of potassium bromate, it cannot be precluded that potassium bromate induces tumours via a mode of action involving direct interaction with genetic material (Canada 2010a).

Exposure to potassium bromate has also been associated with a variety of non-cancer effects in experimental animals. These non-cancer effects include reproductive and immunological effects, as well as effects in the kidney, thyroid, testes, and pituitary gland. Since exposure to potassium bromate is expected to be negligible and the most sensitive non-cancer effects occurred at a dose level at which pre-neoplastic lesions and tumours were also observed, margins of exposure were not calculated for non-cancer effects. (Canada 2010a).

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4. Current Uses and Industrial Sectors

According to information reported under section 71 of CEPA 1999, less than 1000 kg of potassium bromate was imported into Canada in 2006. No company reported manufacturing potassium bromate in Canada in 2006 (Environment Canada 2009).

Two of three uses of potassium bromate reported under section 71 of CEPA 1999 are confidential; however, these uses have predominantly industrial and commercial applications (Environment Canada 2009).

Potassium bromate used to be a permitted food additive in Canada under the Food and Drugs Regulations, but it was delisted in 1994, and therefore is no longer permitted to be used as a food additive in foods offered for sale in Canada (2009 and 2010 personal communication from Food Directorate, Health Canada; unreferenced). One company reported using potassium bromate as an oxidizer in flour milling; however, it also reported that the entire final product is exported to the United States (Environment Canada 2009). The United States Code of Federal Regulations permits potassium bromate to be used in various flours (US FDA 2009ab) and in the malting of barley (US FDA 2009c). Potassium bromate may be present as an impurity in a processing aid for paper food packaging; however, as the food packaging is coated either with a plastic or wax, no contact with food would be expected (2009 personal communication from Food Directorate, Health Canada; unreferenced). As a result of the aforementioned considerations, the potential of exposure from food is expected to be negligible (Canada 2010a).

Potassium bromate has been used as an oxidizing reagent in laboratories and in the dyeing of textiles (sulphur dyes). Historical data indicates the cosmetics industry has also used it as an oxidizer or neutralizer in permanent wave neutralizing solutions (IARC 1999; WHO 2005; HSDB 2009), although no current uses were identified.

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5. Presence in the Canadian Environment and Exposure Sources

5.1 Releases to the Environment

No environmental releases of potassium bromate in 2006 were reported under section 71 of CEPA 1999 (Environment Canada 2009). Environmental releases reported under the National Pollutant Release Inventory (NPRI) indicated that 21 kg of potassium bromate was released into air in 2007; however, no environmental releases were reported during the years 1994–2006 (NPRI 2009). In addition to environmental releases, information submitted under section 71 of CEPA 1999 revealed that less than 10 kg of potassium bromate was transferred to off-site waste management facilities (Environment Canada 2009).

5.2 Exposure Sources

Potassium bromate is a strong oxidizing agent, thus historically it has had many applications. It has been used as an oxidizing reagent in laboratories and in the dyeing of textiles (sulphur dyes). The cosmetics industry has also used it as an oxidizer or neutralizer in permanent wave neutralizing solutions (HSDB 2009, WHO 2005, IARC 1999). The use of potassium bromate in cosmetics triggers labelling and packaging requirements as per theCosmetic Regulations and the Consumer Chemicals and Containers Regulations. These requirements are summarized in the listing of potassium bromate on Health Canada’s Cosmetic Ingredient Hotlist (Health Canada 2009). However, no companies reporting under section 71 of CEPA 1999 reported manufacturing or importing potassium bromate in personal care products in Canada (Environment Canada 2009). In addition, there were no reports of potassium bromate use in personal care products in Health Canada’s Cosmetic Notification System (CNS) (2009 personal communication, Health Canada, unreferenced). Furthermore potassium bromate was not present in products listed in the Household Products Database (HPD), which is a United States database maintained by the United States Department of Health and Human Services (US HHS 2010).

In certain instances the bromate ion (which is also referred to as bromate, and which is a component ion of many salts including potassium bromate and sodium bromate) may be formed in drinking water treated with ozone as a disinfectant via the oxidation of naturally-occurring bromide present in water (Bonacquisti 2006, Krasner et al 1993ab, IARC 1999, US EPA 2001ab, Health Canada 1998, WHO 2005, Weinberg 2003) or may be present in drinking water treated with sodium hypochlorite for disinfection purposes as a result of manufacturing and/or the conditions under which the sodium hypochlorite is transported and stored (Asami et al 2009, Water Research Foundation, 2009). Health Canada’s Guidelines for Canadian Drinking Water Quality set a maximum acceptable concentration of 0.01 mg/L for bromate in drinking water (Health Canada 1998). The drinking water guideline for bromate applies to any source of bromate, including all bromate salts. However, no environmental releases of potassium bromate were reported in 2006 under section 71 of CEPA 1999 (Environment Canada 2009) or in 2008 under the National Pollutant Release Inventory (NPRI 2010). In addition, potassium bromate is not added directly to or used to treat drinking water. Thus, potassium bromate is not expected to be a significant source of bromate ions in drinking water and exposure to the general population to potassium bromate from drinking water is expected to be negligible.

In summary, based on available information from various sources and results from a survey under section 71 of CEPA 1999, exposure to the general population to potassium bromate in environmental media (e.g., drinking water) and in consumer products is considered to be negligible (Canada 2010a).

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6. Overview of Existing Actions

6.1 Existing Canadian Risk Management

6.2 Existing International Risk Management

United States

Europe

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7. Considerations

7.1 Alternative Chemicals or Substitutes

No information on potential substitutes for potassium bromate has been identified.

7.2 Alternative Technologies and/or Techniques

No alternative technologies and/or techniques were identified that would minimize or eliminate the use and/or release of the substance.

7.3 Socio-economic Considerations

Socio-economic factors have been considered in the selection process for a regulation and/or instrument respecting preventive or control actions, and in the development of the risk management objective(s). Socio-economic factors will also be considered in the development of regulations, instrument(s) and/or tool(s) as identified in the Cabinet 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 potassium bromate include:

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.

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8. Proposed Objectives

8.1 Human Health Objective

A human health objective is a quantitative or qualitative statement of what should be achieved to address human health concerns identified during a risk assessment.

The proposed human health objective for potassium bromate is to minimize human exposure to the greatest extent practicable.

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).

As exposures to potassium bromate are considered to be negligible under current use conditions, the proposed risk management objective for potassium bromate is to prevent increases in exposure.

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9. Proposed Risk Management

9.1 Proposed Risk Management Tool and Regulation

As required by the Government of Canada’s Cabinet Directive on Streamlining Regulation[3], and criteria identified in the Treasury Boarddocument entitledAssessing, Selecting, and Implementing Instruments for Government Action, the proposed risk management tools 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 human health objective, the risk management being considered for potassium bromate is:

  1. The Government of Canada plans to implement Significant New Activity provisions under CEPA 1999.
    This would require that any proposed new manufacture, import or use be subject to further assessment, and would determine if the new activity requires further risk management consideration; and

  2. The Government of Canada plans to amend theCosmetic Regulations to change potassium bromate from a substance that triggers labelling and packaging requirements to a substance that is prohibited in cosmetics. The Government of Canada also plans to update the corresponding listing for potassium bromate on Health Canada’s Cosmetic Ingredient Hotlistto reflect the amendment of the Cosmetic Regulations.
    These actions will prevent the re-introduction of potassium bromate into cosmetic products such as home permanent wave kits.

9.2 Implementation Plan

The proposed regulation or instrument respecting preventative or control actions in relation to potassium bromate will be published in the Canada Gazette, Part 1, no later than September 2012, as per the timelines legislated in CEPA 1999.

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10. Consultation Approach

The risk management scope document for potassium bromate, which summarized the proposed risk management under consideration at that time, was published on March 20, 2010. Industry and other interested stakeholders were invited to submit comments on the risk management scope document 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 proposed risk management approach documents will involve publication on September 18, 2010, and a 60-day public comment period. 

The primary stakeholders include:

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11. Next Steps / Proposed Timeline

ActionsDate
Electronic consultation on proposed risk management approach documentSeptember 18, 2010 to November 17, 2010
Response to comments on the proposed risk management approach documentNo later than the time of publication of the proposed instrument
Consultation on the draft instrument2011 - 2012
Publication of the proposed instrumentNo later than September 2012
Formal public comment period on the proposed instrumentNo later than fall 2013
Publication of the final instrumentNo later than March 2014

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 November 17, 2010, since the risk management of potassium bromate will be moving forward after this date. During the development of regulations, instrument(s) and 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, Quebec  K1A 0H3
Tel: 1-888-228-0530 / 819-956-9313
Fax: 819-953-7155
Email: Existing.Substances.Existantes@ec.gc.ca

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12. References

Asami, M., Kosaka, K. and Kunikane, S. 2009. Bromate, chlorate, chlorite and perchlorate in sodium hypochlorite solution used in water supply, Journal of Water Supply: Research and Technology--AQUA Vol 58 No 2 pp 107–115 © IWA Publishing 2009 doi:10.2166/aqua.2009.014

Bonacquisti TP. 2006. A drinking water utility's perspective on bromide, bromate, and ozonation. Toxicology 221: 145-148.

Canada. 1999. Canadian Environmental Protection Act, 1999. S.C. 1999, Ch. 33. Canada Gazette, Part III 22(3). Ottawa: Queen’s Printer. Available from: http://www.gazette.gc.ca/archives/p3/1999/g3-02203.pdf.

Canada. 2000. Canadian Environmental Protection Act, 1999: Persistence and Bioaccumulation Regulations, P.C. 2000-348, 23 March 2000, SOR/2000-107. Available from: http://www.gazette.gc.ca/archives/p2/2000/2000-03-29/pdf/g2-13407.pdf

Canada. 2009. Food and Drugs Act: Cosmetic Regulations[C.R.C., c. 869]. Current to December 28, 2009. Available from: http://laws.justice.gc.ca/eng/C.R.C.-c.869/index.html

Canada. 2010a. Dept. of the Environment, Dept. of Health. 2010. Screening Assessment for Bromic acid, potassium salt (CAS RN 7758-01-2). Available from: http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-9/index-eng.php

Canada. 2010b. Food and Drugs Act: Food and Drug Regulations[C.R.C., c. 870] as amended June 9, 2010. Available from: http://laws.justice.gc.ca/eng/C.R.C.-c.870/index.html

Environment Canada. 2009. Data for Batch 9 substances collected under the Canadian Environmental Protection Act, 1999, section 71:Notice with respect to certain Batch 9 Challenge substances. Data prepared by: Environment Canada, Health Canada, Existing Substances Program.

Environment Canada. 2006. Data for selected substances collected under the Canadian Environmental Protection Act, 1999, Section 71: Notice with respect to selected substances identified as priority for action. Prepared by: Environment Canada, Health Canada, Existing Substances Program.

[ESIS] European Chemical Substances Information System [database on the Internet]. 2010. European Chemicals Bureau (ECB). [cited June 28, 2010]. Available from http://ecb.jrc.ec.europa.eu/esis/.

European Council. 2004. Commission Directive 2004/93/EC of 21 September 2004 amending Council Directive 76/768/EEC for the purpose of adapting its Annexes II and III to technical progress. Official Journal of the European Union L 300/13. Available from:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:300:0013:0041:en:PDF

European Council. 2008. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance). OJ L 353, 31.12.2008, p. 1–1355. Available from:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT

Health Canada. Bromate. Guidelines for Canadian Drinking Water Quality [Internet]. 1998. Available from: http://www.hc-sc.gc.ca/ewh-semt/pubs/water-eau/bromate/index-eng.php

Health Canada. 2008. Guidelines for Canadian Drinking Water Quality Summary Table. Prepared by the Federal-Provincial-Territorial Committee on Drinking Water of the Federal-Provincial-Territorial Committee on Health and the Environment, May 2008. Available from: http://www.hc-sc.gc.ca/ewh-semt/pubs/water-eau/sum_guide-res_recom/index-eng.php

Health Canada. Cosmetic Ingredient Hotlist. September 2009. Available from: http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-critique/hotlist-liste-eng.php

[HSDB] Hazardous Substances Data Bank [database on the Internet]. 1983– . Bethesda (MD): National Library of Medicine (US). [revised 1998; cited 2009 Oct]. Available from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB

[IARC] IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. 1999. Potassium bromate. IARC Monogr Eval Carcinog Risks Hum 73:481–496.

Industry Canada. 2010a. Canadian Industry Statistics – Definition – Flour Milling (NAICS 311211). [Internet]. [cited June 30, 2010]. Available from: http://www.ic.gc.ca/cis-sic/cis-sic.nsf/IDE/cis-sic311211defe.html

Industry Canada. 2010b. Trade by Industry – Flour Milling (NAICS 311211). [Internet]. Ottawa (Canada). Trade Data Online. [cited June 30, 2010]. Available from: http://www.ic.gc.ca/cis-sic/cis-sic.nsf/IDE/cis-sic311211inte.html

Krasner SW, Glaze WH, Weinberg HS, Daniel PA, Najm IN. 1993a. Formation and control of bromate during ozonation of waters containing bromide. Jour. AWWA,85:1:73.

Krasner, SW, Glaze WH, Weinberg HS, Daniel PA. 1993b. Bromate occurrence and control: Pilot and full scale studies. Proceedings of AWWA Annual Conference. San Antonio.

[NPRI] National Pollutant Release Inventory [database on the Internet]. 2009. Gatineau (QC): Environment Canada. [cited 2009 Sept]. Available from: http://www.ec.gc.ca/inrp-npri/

[NPRI] National Pollutant Release Inventory [database on the Internet]. 2010. Gatineau (QC): Environment Canada. [updated January 24, 2010]

[OECD] Organisation for Economic Co-operation and Development. 2004. The 2004 OECD List of High Production Chemicals. [Internet]. Paris (FR): OECD, Environment Directorate. [cited June 28, 2010]. Available from: http://www.oecd.org/dataoecd/55/38/33883530.pdf.

[OECD] Organisation for Economic Co-operation and Development. 2009. The 2007 OECD List of High Production Chemicals. [Internet]. Paris (FR): OECD, Environment Directorate. [cited June 28, 2010]. Available from: http://www.oecd.org/dataoecd/32/9/43947965.pdf

Statistics Canada. Table 301-0006 - Principal statistics for manufacturing industries, by North American Industry Classification System (NAICS), annual (dollars unless otherwise noted), CANSIM (database), Using E-STAT (distributor). [cited June 28, 2010]
http://estat.statcan.gc.ca/cgi-win/cnsmcgi.exe?Lang=E&EST-Fi=EStat/English/CII_1-eng.htm

Treasury Board of Canada Secretariat. 2007. Cabinet Directive on Streamlining Regulation, section 4.4. http://www.regulation.gc.ca/directive/directive01-eng.asp

[TRI] Toxics Release Inventory [database on the Internet]. 2009. TRI Explorer 4.9. Washington (DC): US Environmental Protection Agency. [cited 2009 Sept]. Available from: http://www.epa.gov/triexplorer/

[UK] United Kingdom. 2008. The Cosmetic Products (Safety) Regulations 2008. Statutory Instruments, Consumer Protection, 2008. No. 1284. Available from: http://www.opsi.gov.uk/si/si2008/pdf/uksi_20081284_en.pdf

[UK] United Kingdom. 1990a. The Potassium Bromate (Prohibition as a Flour Improver) Regulations 1990. Statutory Instrument 1990 No. 399. Available from: http://www.opsi.gov.uk/si/si1990/Uksi_19900399_en_1.htm

[UK] United Kingdom. 1990b. The Potassium Bromate (Prohibition as a Flour Improver) Regulations (Scotland) 1990. Statutory Instrument 1990 No. 395 (S.44). Available from: http://www.opsi.gov.uk/si/si1990/Uksi_19900395_en_1.htm

[US CPSC] United States Consumer Product Safety Commission. 2009. Code of Federal Regulations, Title 16, Vol 2, Part 1700.14. [cited 2010 Jan]. Available from: http://www.access.gpo.gov/nara/cfr/waisidx_09/16cfr1700_09.html

[US EPA] United States Environmental Protection Agency. 2001a. Toxicological review of bromate, in support of summary information on the Integrated Risk Information System (IRIS) March 2001. EPA/635/R-01/002. Washington, DC. Available from: http://www.epa.gov/ncea/iris/toxreviews/1002tr.pdf

[US EPA] United States Environmental Protection Agency. 2001b. Bromate (CASRN 15541-45-4) Washington (DC): US EPA, Integrated Risk Information System (IRIS). [cited 2009 Oct]. Available from:http://www.epa.gov/iris/subst/1002.htm

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[US FDA] US Food and Drug Administration. 2009a. Cereal Flours and Related Products [Internet]. Rockland (MD): US FDA, Center for Food Safety and Applied Nutrition. [cited 2010 Jan]. Code of Federal Regulations Title 21, Vol. 2, sections 137 155 and 137 160. Available from: http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr137.165.pdf

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[US FDA] US Food and Drug Administration. 2009c. Food additives permitted for direct addition to food for human consumption [Internet]. Rockland (MD): US FDA, Center for Food Safety and Applied Nutrition. [cited 2010 Jan]. Code of Federal Regulations Title 21, Vol. 3, sections 172 730 137 205. Available from:http://edocket.access.gpo.gov/cfr_2009/aprqtr/pdf/21cfr172.730.pdf

[US FDA] US Food and Drug Administration. 2009d. Code of Federal Regulations. Title 21, Vol 2, Part 136.110 Available from: http://www.access.gpo.gov/nara/cfr/waisidx_09/21cfr136_09.html

[US FDA] US Food and Drug Administration. 2009e. Code of Federal Regulations. Title 21, Vol 2, Part 165.110 Available from: http://www.access.gpo.gov/nara/cfr/waisidx_09/21cfr165_09.html

[US HHS] US Department of Health and Human Services. 2010.Household Products Database – Health and Safety Information on Household Products. Accessed Jan 2010. Available from:http://householdproducts.nlm.nih.gov/index.htm

Water Research Foundation. 2009. Hypochlorite - An Assessment of Factors That Influence the Formation of Perchlorate and Other Contaminants; Water Research Foundation, Denver, CO (Report 4147).

Weinberg HS, Delcomyn CA, Unnam V. 2003. Bromate in chlorinated drinking waters: Occurrence and implications for future regulation. Environmental science & technology 37:3104 -3110.

[WHO] World Health Organization. 2005. Bromate in drinking-water. Background document for the development of WHO Guidelines for Drinking-water Quality. Geneva (CH): World Health Organization. WHO/SDE/WSH/05.08/78. Available from: http://www.who.int/water_sanitation_health/dwq/chemicals/bromate030406.pdf

[WHO] World Health Organization. 2008. Guidelines for Drinking-water Quality, Third Edition, Incorporating The First And Second,Addenda Volume 1. Available from: http://www.who.int/water_sanitation_health/dwq/fulltext.pdf


Footnotes

[1] A determination of whether one or more of the criteria of section 64 are met is based upon an assessment of potential risks to the environment and/or to human health associated with exposures in the general environment. For humans, this includes, but is not limited to, exposures from ambient and indoor air, drinking water, foodstuffs, and the use of consumer products. A conclusion under CEPA 1999 is not relevant to, nor does it preclude, an assessment against the hazard criteria specified in the Controlled Products Regulations, which is part of the regulatory framework for the Workplace Hazardous Materials Information System [WHMIS] for products intended for workplace use.
[2] CAS RN: Chemical Abstracts Service Registry Number. The Chemical Abstracts Service information is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior written permission of the American Chemical Society.
[3] Section 4.4 of the Cabinet Directive on Streamlining Regulation states 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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