Summary of public comments received on the draft screening assessment for Sodium ortho-phenylphenate (SOPP)
Comments on the draft Screening Assessment for Sodium ortho-phenylphenate (SOPP), assessed under the Chemicals Management Plan (CMP), were submitted by an individual and by the Canadian Consumer Specialty Products Association (CCSPA).
Summarized public comments and responses from the Government of Canada are provided below, organized by topic:
Overarching comments
Comment summary 1: The draft screening assessment lacks some information on exposure potential, environmental impacts, workplace hazard potential and environmental fate and health effects on chronic exposure of the product.
Response 1: Screening assessments conducted under the Canadian Environmental Protection Act, 1999 (CEPA) are based on the best available data and focus on information critical to determining whether substances meet the criteria as set out in section 64 of CEPA, by examining scientific information and incorporating a weight of evidence approach and precaution. Information gathering encompasses a wide variety of published and unpublished sources. The screening assessments focus on risks of exposure to the general population. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS).
The Government of Canada is currently working with the provinces and territories to explore ways to enhance the protection of workers from exposure to chemicals by integrating and leveraging the information, tools, and/or technical expertise of the Chemicals Management Plan and Health Canada’s Workplace Hazardous Products Program.
Additionally, all substances that have undergone assessment remain subject to future evaluation if new information is identified that indicates further consideration is warranted. The application of the Significant New Activity (SNAc) provisions under CEPA 1999 requires that any proposed new manufacture, import or use of the substance be subject to further assessment. SNAc provisions also determine if the proposed new activity requires further risk management consideration. New information can be submitted through several mechanisms defined under specific sections of CEPA and other legislation.
Comment summary 2: Contact us if further input is needed during finalization of the assessment.
Response 2: Noted.
Comment summary 3: The Government of Canada should make some changes in regulations to mitigate consumer exposure to SOPP through proper labelling and limiting its use in food packaging, non-prescription health products, and cosmetics.
Response 3: The screening assessment concluded that current levels of exposure do not pose a risk to human health for the general population.
Although SOPP is not a concern at current exposure levels, there may be a concern if human exposure to SOPP was to increase. For this reason, follow-up activities to track any future changes in exposure are being considered. The application of the Significant New Activity (SNAc) provisions under CEPA 1999 requires that any proposed new manufacture, import or use of the substance be subject to further assessment. SNAc provisions also determine if the proposed new activity requires further risk management consideration.
Information submitted by stakeholders during the 60-day public comment period on the assessment were considered in determining potential follow-up activities.
Uses, exposure, and hazard information
Comment summary 4: SOPP is being used in material preservation in a range of products, such as slurries, paints, stains, cleaning solutions, and wood products, to protect them from biodegradation. It is also being used in agriculture for post-harvest preservation of citrus and pears and to preserve formulations applied to food crops. Also, SOPP and OPP are the active ingredient in disinfectants used in agriculture, residential, and industrial use.
Consumer exposure to SOPP may occur with the application of disinfectant products to hard surfaces, as well as dietary exposure as the result of food contact to the treated surface.
Response 4: Known and relevant uses and sources of exposure of SOPP are considered in CMP screening assessments using available information.
SOPP was not identified in paints, stains, cleaning solutions, and household disinfectants for use by the general population in Canada.
Uses of SOPP in agricultural food crops and as a material preservative agent (e.g., in wood products) is regulated by Health Canada’s Pest Management Regulatory Agency. In 2008, Health Canada’s Pest Management Regulatory Agency re-evaluated 2-phenylphenol (OPP) and its salts (including SOPP). They concluded that there was not a human health risk from their uses as material preservative agents, and considered chronic dietary exposure to pesticide food residues (Health Canada 2008a).
Uses of SOPP as an active ingredient in disinfectants is regulated under Health Canada’s Health Products and Food Branch.
SOPP may also be used as a component in incidental additives (e.g., cleaners, lubricants) used in food processing establishments. Exposure from its use in incidental additives is not expected, since there is no direct food contact with the incidental additive.
Occupational exposures
Comment summary 5: SOPP might have serious health effects from chronic occupational exposure, though it is considered non-toxic under a certain concentration. Statements provided by DOW researchers and the European Commission contradict the International Agency for Research on Cancer (IARC), which suggests SOPP is possibly carcinogenic to humans.
European Commission of Health and Food Safety studies showed some skin irritation from OPP and SOPP. Chronic exposure to these substances in the workplace might be harmful for workers.
Occupational exposure can occur in manufacturing, formulating, or industrial facilities that use OPP and/or SOPP. Facilities with SOPP onsite should have a thorough training program for employees, appropriate work processes and safety equipment in place to limit unnecessary exposure.
An exposure threshold limit should be determined and must be available to manufacturers and workers in order to mitigate health effects in the workplace.
Response 5: Screening assessments conducted under CEPA are based on the best available data. Under the CMP, they focus on risks of exposure to the general population. Exposure threshold limits in the workplace are beyond the scope of screening assessment reviews under CMP. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System.
The Government of Canada is currently working with the provinces and territories to explore ways to enhance the protection of workers from exposure to chemicals by integrating and leveraging the information, tools, and/or technical expertise of the Chemicals Management Plan and Health Canada's Workplace Hazardous Products Program.
Environmental assessment
Comment summary 6: OPP and SOPP are practically non-toxic to birds on a dietary basis. However, on an acute basis, SOPP and OPP are highly toxic to aquatic organisms and should be prevented from entering soil, ditches, sewers, waterways, and/or groundwater.
SOPP is stable in water unless exposed to sunlight. SOPP degrades into OPP in water. OPP meets the criteria to be classified as readily biodegradable, where it readily degrades in surface water and waste mixtures.
SOPP does not have bioaccumulation potential, but OPP might be prone to bioaccumulation during chronic exposure.
Response 6: Based on the information considered under the Ecological Risk Classification of organic substances (ERC) Approach, SOPP was classified as having a low ecological hazard and low exposure potential. ERC employs multiple metrics for both hazard and exposure based on weighted consideration of multiple lines of evidence determining risk classification. On the basis of current use patterns, this substance is unlikely to be resulting in concerns for the environment in Canada. Bioaccumulation data submitted is consistent with the modelled bioconcentration factor/bioaccumulation factor (BCF/BAF) data used in the ERC approach.
The ecological risk of OPP was not characterized using ERC as it was used mainly as an analogue (i.e., structurally and functionally similar to SOPP) to inform the human health assessment. In addition, OPP is not expected to persist in the environment and is reported to be photolytically unstable in a neutral aqueous medium and to degrade completely in 14 days when exposed to sunlight (Health Canada 2008b)
Comment summary 7: Environmental exposure can occur through effluent streams from waste water and accidental spills, which could be harmful to wildlife and the environment.
Response 7: Based on the information considered under the ERC Approach, SOPP was classified as having a low ecological exposure potential. Exposure profiles under ERC are based on multiple metrics, including potential emission rate, overall persistence, and long-range transport potential. In ERC, wastewater treatment system (WWTS) removal is used to determine the emission rate to water after treatment as well as the fraction of chemical quantity that could be applied to agricultural lands in association with biosolids. The ERC approach conservatively assumes that 100% of the chemical quantity reported to be in commerce can be released to a WWTS.
SOPP is expected to degrade rapidly in the environment. Due to the immobility of SOPP in soils, it is not likely to leach to groundwater or contaminate surface water through runoff.
References
Health Canada. 2008a. Re-evaluation Decision: 2-Phenylphenol and salts. No. RVD2008-13; 7 April 2008. Pest Management Regulatory Agency. 5 pp
Health Canada. 2008b. Proposed Re-evaluation Decision: 2-Phenylphenol and salts. No. PRVD2008-04; 25 Jan. 2008. Pest Management Regulatory Agency. 23 pp.
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