Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
PROPOSED FEDERAL REGULATION - VIA PART I OF THE GAZETTE
December 11, 2016
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The Government of Canada (the Government) has conducted a scientific assessment (see footnote 1) on triclosan (see footnote 2) to determine whether the activities associated with the substance could constitute a danger to human health or the environment in Canada. The assessment determined that triclosan meets ... (Click for more)
Published on December 11, 2016
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues The Government of Canada (the Government) has conducted a scientific assessment (see footnote 1) on triclosan (see footnote 2) to determine whether the activities associated with the substance could constitute a danger to human health or the environment in Canada. The assessment determined that triclosan meets the environmental toxicity criteria as defined in paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA). Therefore, the Government is proposing to add this substance to the List of Toxic Substances in Schedule 1 of CEPA. Background Prior to 1994, chemicals were introduced into Canadian commerce without assessment of potential ecological or human health risks. Starting in 1994, all chemicals new to the Canadian market were subject to regulatory risk assessments to determine if there were concerns for human health or the environment. In 2006, Canada completed the process of categorization of 23 000 substances in commerce and determined that 4 300 of these substances needed to undergo a screening assessment to determine if they pose ecological or human health risks. On December 8, 2006, the Chemicals Management Plan (CMP) was launched by the Government with the aim of processing these substances by 2020. (see footnote 3) Triclosan, which is one of the 4 300 priority substances and is subject to the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999, is a substance on the Domestic Substances List that was identified under CEPA as a priority substance for assessment based on ecological concerns. In 2013, in response to mandatory surveys issued under the authority of CEPA, industry submitted data to the Government on activities related to triclosan. Extensive data relevant to the assessment was identified in the scientific literature and review documents, as well as commercial and government databases. Efforts were made to contact academics, researchers, and government agencies to obtain relevant information on triclosan. In addition, under numerous monitoring and surveillance initiatives funded by the CMP, additional information on triclosan has become available (up to April 2015). These initiatives include the Second Report on Human Biomonitoring of Environmental Chemicals in Canada, the Maternal-Infant Research on Environmental Chemicals Study, and the Plastics and Personal Care Product Use in Pregnancy Study. Additionally, information on triclosan is available as part of the CMP Environmental Monitoring and Surveillance Program. Substance description and sources of release Triclosan is a synthetic organic chemical, used as a material preservative and antibacterial active ingredient in a wide range of products used by consumers to stop the growth of bacteria, fungi, and mildew, and to prevent odours. In Canada, the use of triclosan in products used by consumers is the major contributor to releases of triclosan into the environment, which results in the continuous release of the substance to aquatic ecosystems via wastewater treatment systems. The industrial manufacture of products containing triclosan is also a source of release of this substance to wastewater; however, based on an analysis of the results obtained through the survey conducted under section 71 of CEPA, the overall relative contribution of triclosan releases to wastewater treatment systems from manufacturing facilities, compared to households, is expected to be minor. Existing and international risk management measures (see footnote 4) In Canada, the use of triclosan in cosmetics, drugs and natural health products is regulated under the Food and Drugs Act. Thus, the use of these products by the general public is not a human health concern. The Department of Health has recommended maximum acceptable limits for triclosan in cosmetics and this is reflected in the Cosmetic Ingredient Hotlist. The Hotlist suggests a concentration of triclosan of no more than 0.03% in mouthwashes and 0.3% in other cosmetics, such as soaps. These limits are consistent with other jurisdictions, for example Australia and the European Union. The Department of Health also has regulations for other products containing triclosan. In order to sell a drug product in Canada, including those containing triclosan as an active ingredient, a manufacturer must submit an application for a Drug Identification Number (DIN) to the Department of Health. These applications are reviewed to determine if the product meets safety, efficacy and quality standards before it can be permitted to be sold in Canada. Triclosan can be used as an anti-microbial preservative in natural health products. Limits for triclosan in natural health products are specified in the Natural Health Products Ingredients Database and are identical to the limits in the Cosmetic Ingredient Hotlist. However, as triclosan is found in many products that are continually washed down the drain, and in the absence of specific risk management measures associated with the environment, these releases of triclosan and associated exposure remain a source of concern. Although in Canada the use of triclosan in pest control–related products (see footnote 5) is regulated under the Pest Control Products Act, as of December 31, 2014, triclosan is no longer registered in Canada as a pest control product. In the United States, the State of Minnesota passed a bill that banned the use of triclosan in some consumer products sold in the state and that comes into effect on January 1, 2017. It states that “No person shall offer for retail sale in Minnesota any cleaning product that contains triclosan and is used by consumers for sanitizing or hand and body cleansing. This shall not apply to individual products for which specific Food and Drug Administration (USA FDA) approval for consumer use has been secured.” In the European Union, under Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures, products containing triclosan are classified both as an irritant to eyes and skin and as dangerous for the environment (for both acute and chronic aquatic exposure). Cosmetic products are exempt from the requirements of this regulation. In addition, in December 2015, the European Union Standing Committee on Biocidal Products ruled that the antibacterial pesticide triclosan is toxic and bioaccumulative and will therefore be phased out for hygienic use in favour of more suitable alternatives. Australia has concluded that triclosan released to wastewater systems from various cosmetic and personal care products during washing and bathing, or from the disposal of cleaning products, may pose a risk to algae, aquatic plants and fish. Further information is being collected on the presence of triclosan in wastewater (effluent and biosolids). Australia concluded that human health risk from triclosan is generally considered to be low. Quantities of triclosan in Canada On February 9, 2013, the Minister of the Environment requested, under section 71 of CEPA, information on the manufacture, import, export, and use of triclosan in a quantity greater than 10 kg and at concentrations of 0.001% or more, excluding any use in pest control products, for the 2011 calendar year. (see footnote 6) In this year, the total quantity imported into Canada ranged from 10 000 kg to 100 000 kg, either as a pure substance to manufacture formulated products or as an ingredient in formulated products. Formulated products containing triclosan include non- prescription drugs and natural health, personal care and cleaning products such as antibacterial soaps, skin cleansers, toothpastes, make-up, deodorants, skin creams, fragrances, general purpose cleaners, and general purpose detergents. While triclosan is not produced in Canada, in the same year, 20 companies reported using triclosan as an ingredient to manufacture formulated products, and 5 companies reported exporting a total between 100 kg and 1 000 kg of triclosan in formulated products. Scientific assessment summary An assessment of triclosan has been conducted by the Department of the Environment and the Department of Health, including the Pest Management Regulatory Agency (PMRA), to determine whether the substance meets one or more of the criteria for a toxic substance set out in section 64 of CEPA. Specifically, this involves determining whether triclosan is entering or may enter the environment in a quantity or concentration or under conditions that (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity; (b) constitute or may constitute a danger to the environment on which life depends; or (c) constitute or may constitute a danger in Canada to human life or health. Both the human health and ecological components of the assessment have undergone external written peer review or consultation, by Canadian and international experts selected from government organizations, academia and stakeholders. Human health assessment summary To determine whether triclosan has the potential to pose a risk to human health, estimates of human exposure to triclosan in Canada (in the general population, as well as in infants and children under the age of three) were compared with levels of triclosan demonstrated in animal studies to cause adverse health effects (liver effects observed in mice). The assessment shows that current levels of exposure to triclosan do not pose a risk to human health for Canadians, including children and pregnant women. (see footnote 7). Considering all available lines of evidence presented in the assessment and the current risk management measures controlling the use of triclosan in products used by consumers, it was concluded that, in Canada, current activities associated with triclosan are not a concern to human life or health. Therefore, it is concluded that triclosan does not meet the criterion as defined in paragraph 64(c) of CEPA. Ecological assessment summary Triclosan is toxic to a variety of aquatic organisms, such as algae, macrophytes, invertebrates, amphibians and fish. Adverse effects that have been observed include reduction in growth, reproduction and survival, and there is evidence of endocrine-disrupting effects at environmentally relevant concentrations. Triclosan can also be highly bioconcentrated in fish, and there is evidence of bioaccumulation in algae and aquatic invertebrates. Triclosan is also toxic to certain soil organisms. Based on an extensive review of the available toxicity data, a predicted no-effect concentration (at or below which no critical impacts on organisms’ survival, reproduction, and growth, etc., would occur) of 376 nanograms per litre (ng/L) was derived for the aquatic compartment. The use of triclosan in products used by consumers is the major contributor to releases of triclosan into the environment in Canada, which results in the continuous release of the substance to aquatic ecosystems via publicly owned wastewater treatment systems. Although wastewater treatment systems may partly remove triclosan, the substance has been found in numerous waterbodies (see footnote 8) across Canada, from both heavily and sparsely populated areas, and has been measured to be in the range of 4 ng/L to 874 ng/L. Though triclosan as an organic chemical tends to degrade relatively quickly in the environment, the monitoring of triclosan in waterbodies across Canada, between early 2000 and 2014, indicated that triclosan continues to be present at steady concentration levels, given its continuous release from wastewater treatment systems. Given the widespread presence of triclosan in waterbodies across Canada, including at levels at or near those that can harm aquatic organisms, it is concluded that the ongoing release of triclosan to the aquatic ecosystem is a source of concern to the environment in Canada. The assessment has therefore determined that triclosan meets the criterion as defined under paragraph 64(a) of CEPA. However, the substance did not meet the criterion under paragraph 64(b) of CEPA. Assessment publication and conclusions On August 20, 2016, the assessment for triclosan was published on the Government of Canada’s Chemical Substances website. Based on the results of the assessment, the Minister of the Environment and the Minister of Health (the ministers) have concluded that triclosan meets the environmental criterion for a toxic substance, as set out under paragraph 64(a) of CEPA, and have therefore recommended the addition of triclosan to Schedule 1 of CEPA. (see footnote 9) Objectives The objective of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the Minister of the Environment (the Minister) to propose risk management measures under CEPA, should such measures be deemed necessary to manage environmental risks associated with triclosan. Description The proposed Order would add triclosan to Schedule 1 of CEPA. “One-for-One” Rule The “One-for-One” Rule does not apply, as the proposed Order would not impose any administrative burden on business. Small business lens The small business lens does not apply, as the proposed Order would not impose any compliance or administrative costs on small business. Consultation On March 31, 2012, the ministers published a preliminary assessment and a risk management scope document for triclosan in the Canada Gazette, Part I, for a 60-day public comment period. (see footnote 10) During the public comment period, 66 submissions were received on the preliminary assessment and risk management scope document. These comments were considered during the preparation of the assessment and the proposed risk management approach document. (see footnote 11) Prior to these publications, the Department of the Environment and the Department of Health informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of these documents and of the related public comment period. No comments were received from CEPA NAC. Summary of public comments and responses An industry stakeholder disagreed with the specific conclusion of the preliminary assessment that triclosan is bioaccumulative under the Persistence and Bioaccumulation Regulations. According to this stakeholder, the Government of Canada should consider a re-evaluation of the bioaccumulation assessment, as it appeared to be biased toward a single study (Schettgen et al., 1999) when there is another study (Orvos et al., 2002) that should also be considered. A comparison of these two studies suggests triclosan may not meet the referenced criteria for bioaccumulation or — at a minimum — that there is sufficient uncertainty in available data to warrant further investigation. Response: Following publication of the preliminary assessment, additional information on the bioaccumulation of triclosan was made available to the Department of the Environment relevant to studies conducted by Schettgen et al. (1999) and by Orvos et al. (2002); other studies were also submitted. This new information was analyzed and incorporated in the final assessment in order to update the bioaccumulation assessment and its relevancy to the ecotoxicity of triclosan. Altogether, the available data indicate that this substance can bioaccumulate but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA. A non-governmental organization commented that the preliminary assessment does not demonstrate that triclosan is removed efficiently by wastewater treatment plants (WWTPs). Therefore, wastewater treatment technology should not be considered an adequate means of controlling and preventing the release of triclosan to the environment. Response: Monitoring data from the Department of the Environment indicate that triclosan is removed efficiently by WWTPs that have a secondary treatment process or a lagoon treatment process (the average removal rate for these processes is greater than 90%). However, WWTPs that only have at most a primary treatment process or no treatment at all (see footnote 12) have low removal rates. It is also recognized that even when the removal rate is high, triclosan can still be released to the environment, either through WWTP effluent or the application of biosolids to soil. A risk of harm to aquatic organisms, but not to terrestrial organisms, was identified in the final assessment. The proposed risk management instrument for triclosan, which aims to control the releases of triclosan into the aquatic environment, is outlined in the proposed risk management approach available on the Chemical Substances website. An industry stakeholder commented that the underlying data relied upon to select predicted environmental concentrations (PECs) reflected in the characterization of aquatic risk are incomplete or unavailable. Therefore, the suitability and rigour of these data and the exposure modelling cannot be assessed. Response: The data relied upon to select PECs for aquatic ecosystems consist of measured concentrations of triclosan in the influents and effluents of WWTPs and surface water. In order to keep the assessment concise, only a summary of these data was included in the assessment (the full data set is available upon request from the Department of the Environment at [email protected]). Due to confidentiality requirements for certain data, some information is not available to the general public. A non-governmental organization commented that there is evidence that triclosan affects the endocrine system. The Government of Canada should characterize the risk to human health based on the endocrine effects of triclosan reported in animal studies. Response: The conclusions that current activities associated with triclosan are not a concern to human life or health, and that triclosan does not meet the human health criterion as defined in paragraph 64(c) of CEPA, were informed by all relevant scientific studies. This included studies that described the potential effects of triclosan on the endocrine system, in particular to thyroid function, including data available from studies in laboratory animals and humans. This ranged from short-term to more chronic scenarios of exposure to triclosan. However, the effects related to thyroid function found in animal studies were not considered relevant in the evaluation of the risk of triclosan to human health. A non-governmental organization commented that the preliminary assessment does not address the cumulative effects of exposure to triclosan and substances that share a similar mechanism of toxicity, such as endocrine disruption. The assessment also does not consider the cumulative effects of exposure (particularly resulting from exposure to different products used by consumers) to triclosan and substances that produce the same toxic metabolites. Response: The risk to human health resulting from the cumulative effects of exposure from all potential sources of triclosan (such as multiple cosmetics, drugs and natural health products) and routes of exposure was considered through the use of human biomonitoring data and a toxicity endpoint considered protective of potential effects in humans. These data (measurements of triclosan in human urine and breast milk, which account for cumulative levels of all sources of exposure to triclosan) were used to characterize both mean and upper-bound exposure estimates for the Canadian general population. These data take into account all potential sources and routes of exposure and are considered the most accurate predictors of aggregate exposure because not only do they include specific measurements of the substance, but they also reflect actual use patterns of various consumer products as they occur in practice. The Department of Health has not identified evidence indicating that triclosan shares a common mechanism of toxicity with other pesticides or shares a toxic metabolite produced by other pesticides. A non-governmental organization commented that the Government of Canada should continue to monitor scientific literature regarding antibacterial resistance and the use of biocides. Response: The assessment included a review of evidence for the potential development of antimicrobial-resistant bacteria and concluded that antimicrobial resistance has not been identified as a concern for human health from current levels of triclosan exposure. Triclosan and all other substances that have undergone assessment remain subject to future evaluation if substantive new information is identified that indicates a need for further consideration. A non-governmental organization commented that the Government of Canada has not provided a scientific or policy rationale to support the methods used in determining the risk of triclosan to human health. This includes a rationale on why certain critical endpoints were selected and how certain safety factors were to account for database deficiencies and to protect infants and children. Response: The Government of Canada considers available evidence for laboratory animals and for humans. The following endpoints were established by the Department of Health for the characterization of human health risks: Oral (e.g. nursing) and all other exposure scenarios with an oral effect, where the oral endpoint no observed adverse effect level (NOAEL) is 25 mg/kg body weight per day from a 90-day toxicity study in mice; Dermal exposure scenarios, where the dermal endpoint NOAEL is 40 mg/kg body weight per day from a 90-day dermal study in rats; and Inhalation exposure scenarios, where the inhalation endpoint NOAEL is 3.21 mg/kg body weight per day from a 21-day inhalation study in rats. Studies on the effects of chemical exposure on animals are often used to inform an understanding of potential effects on human health. To account for potential differences in exposure-related health effects between animals and humans, and to ensure a protective margin of safety, the Department of Health applies various uncertainty factors to the toxicity levels that were measured in the animal studies when determining potential risk to human health. The total uncertainty factor used for the assessment of health effects from triclosan was 300, and included a 10-fold factor to account for variations between species, a 10-fold factor to account for variations within a species, and a 3-fold uncertainty factor to account for database deficiency (i.e. lack of neurodevelopmental studies on triclosan). This uncertainty factor of 300 was applied to all routes and durations of exposure in the triclosan assessment, and is considered to provide a sufficient margin of safety to protect human health from potential risks. Rationale Triclosan is a chemical currently used as an antibacterial agent in a variety of products used by consumers. The wide range of uses of triclosan in cosmetics, drugs and natural health products results in its continual release to aquatic ecosystems via publicly owned wastewater treatment systems. Triclosan is hazardous to a number of non-human organisms and can cause adverse effects in organisms even at low exposure levels in the environment. These effects, which include reduction in growth, reproduction and survival, have been observed in studies with aquatic invertebrates and vertebrates, as well as terrestrial organisms including plants. Therefore, the assessment concluded that the continuous release of triclosan into publicly owned wastewater treatment systems in Canada has the potential to cause ecological harm, and that triclosan meets one or more of the criteria as defined in section 64 of CEPA. One of the following measures must be proposed after an assessment is conducted under CEPA: taking no further action with respect to the substance; adding the substance to the Priority Substances List for further assessment; or recommending that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA and, where applicable, recommending the implementation of virtual elimination. Based on the available evidence, which includes data received from industry about the use of triclosan in Canada and the conclusions of the scientific human health and ecological assessment, the Government has determined that choosing option 1 or 2 is not appropriate to manage the potential ecological risk associated with the continuous releases of triclosan into the environment in Canada. Therefore, option 3, which recommends that triclosan be added to the List of Toxic Substances in Schedule 1 of CEPA, is the option proposed by the ministers. The proposed addition of triclosan to Schedule 1 of CEPA would not result in any incremental impacts (benefits or costs) on the public or industry, since the proposed Order would not impose any compliance requirements on stakeholders. Accordingly, there would be no compliance or administrative burden imposed on small businesses or businesses in general. Rather, the proposed Order enables the Minister to propose risk management measures under CEPA, should such measures be deemed necessary to manage potential ecological risks associated with triclosan. If further risk management measures are deemed necessary for triclosan, the Minister will assess the costs and benefits, if required, and consult with the public and other stakeholders during the development of any risk management measure to address potential environmental concerns associated with the uses of triclosan in Canada. Strategic environmental assessment In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed. (see footnote 13) Implementation, enforcement and service standards The proposed Order would add triclosan to Schedule 1 of CEPA, thereby enabling the Minister to propose risk management measures respecting preventive or control actions under CEPA. Developing an implementation plan and an enforcement strategy and establishing service standards are only considered necessary when a specific risk management approach is proposed. As the proposed Order does not include a specific risk management proposal, there is no requirement for implementation, enforcement or service standards. Contacts Greg Carreau Program Development and Engagement Division Department of the Environment Gatineau, Quebec K1A 0H3 Substances Management Information Line: 1-800-567-1999 (toll-free in Canada) 819-938-3232 (outside of Canada) Fax: 819-938-5212 Email: [email protected] Michael Donohue Risk Management Bureau Department of Health Ottawa, Ontario K1A 0K9 Telephone: 613-957-8166 Fax: 613-952-8857 Email: [email protected] PROPOSED REGULATORY TEXT Notice is given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999. Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3 (fax: 819-938-5212; email: [email protected]). A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act. Ottawa, December 1, 2016 Jurica Čapkun Assistant Clerk of the Privy Council Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 Amendment 1 Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 14) is amended by adding the following: Phenol, 5-chloro-2-(2,4-dichlorophenoxy)-, which has the molecular formula C12H7Cl3O2 Coming into Force 2 This Order comes into force on the day on which it is registered. [50-1-o] Footnote 1 For more information on the scientific assessment for triclosan, please see http://www.ec.gc.ca/ese-ees/6EF68BEC-5620-44358729-9B91C57A9FD2/Triclosan_EN.pdf. Footnote 2 Triclosan’s Chemical Abstracts Service Registry Number is 3380-34-5 and its chemical name is phenol, 5-chloro2-(2,4-dichlorophenoxy). Footnote 3 For more information on the CMP, please visit the Chemical Substances website at http://www.chemicalsubstanceschimiques.gc.ca/index-eng.php/. Footnote 4 For more information on existing risk management measures associated with triclosan, please see http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/triclosan-eng.php. Footnote 5 Under section 2 of the Pest Control Products Act, “pest control product” means (a) a product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants, and that is manufactured, represented, distributed or used as a means for directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects; (b) an active ingredient that is used to manufacture anything described in paragraph (a); or (c) any other thing that is prescribed to be a pest control product. Footnote 6 For more information on the mandatory survey, including to whom it applied, please see http://gazette.gc.ca/rp-pr/p1/2013/2013-02-09/pdf/g1-14706.pdf (page 175). Footnote 7 For more information on the human health assessment for triclosan, please see the assessment on the Chemical Substance website at http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/triclosan-eng.php#a2. Footnote 8 Examples of these waterbodies are the Grand River, Ottawa River, Saint-Maurice River, St. Lawrence River, Red River, Columbia River, Fraser River, Mill Creek River, Wascana Creek River, Waterford River, and Saint John River. Footnote 9 The final assessment report and other related publications can be obtained from the Chemical Substances website or from the Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3; fax: 819-938-5212; email: [email protected] Footnote 10 The preliminary assessment is available at http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/triclosan-eng.php. Footnote 11 The comments and responses to the comments regarding the preliminary assessment and the risk management scope document can be found on the Chemical Substances website. Footnote 12 Based on data from 2004, 26% of the 22 million Canadians serviced by sewer systems were provided with primary wastewater treatment or less. Footnote 13 See http://www.chemicalsubstanceschimiques.gc.ca/plan/sea-ees-eng.php. Footnote a S.C. 2004, c. 15, s. 31 Footnote b S.C. 1999, c. 33 Footnote 14 S.C. 1999, c. 33
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