NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division Case number: 2017-024723 Product: Wire Bristle Barbecue/Grill Cleaning Brush Date approved: 2017-08-16 1.0 PRODUCT SUMMARY Common name: Brand name: Wire Bristle Barbecue/Grill Cleaning Brush Product description: Wire brush constructed from tufts of straight or kinked, metal wire bristles (i.e., stiff, sharp strands of metal), which are typically inserted into holes in the brush head. The head and handle are usually either plastic or wood, of varying shape and length. Various/Multiple Figure 1a: Plastic head/handle construction Figure 1b: Wooden head/handle construction Figure 1: Two typical examples of wire brushes for cleaning a barbecue grill 1 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division Instructions and warnings: Figure 2: Photo of warning label affixed to product sample. Figure 3: Photo of safety label accompanying a different product sample. Intended user(s): Operators of barbecues or other grilling devices. Note: For the purposes of this risk assessment report, those who could be affected by the product would include all individuals who eat food prepared on a barbecue grill which was cleaned by a metal wire bristle brush. Country of origin: Various 2 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division Business name and address: Various Product distribution and sales: Total unknown. The following brands of wire bristle barbecue brushes are available in Canada (note, this is not an exhaustive list): - [REDACTED] One retailer, [REDACTED], indicated that they sell [REDACTED] product units annually. It is currently unknown what portion of the overall market this represents. Additional notes: 2.0 CASE AND INJURY INFORMATION Reports received: ☒ Industry reporting: 14(2): ☒ Retailer ☐ Importer ☐ Distributor ☐ Manufacturer 14(3): ☒ Importer ☐ Manufacturer ☐ Proposed Corrective Measures ☐ No Proposed Corrective Measures Notification “not an incident”: ☐ Retailer ☐ Distributor ☐ Importer ☐ Manufacturer ☒ Consumer reporting ☐ Cosmetic assessment (specify type) ☒ Other (specify type): Published articles. Unit: ☒ Mechanical & Physical ☐ Electrical Incident information: The reported incidents received by Health Canada are related to the safety concern associated with the ingestion of metal wire bristle(s) which had detached or broken away from a barbecue cleaning brush. The detached/broken wire bristle(s) remained on the barbecue grill itself, and subsequently the bristle(s) adhered to the food being cooked on the barbecue grill. 3 of 22 ☐ Toxicology & Flammability 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division Case 2017-024723 has been created to consolidate all reported cases to Health Canada known at the time of case creation. Samples of incident descriptions from 4 cases are as follows: Previous Health Canada reporting: i) 2016-046885: From Importer: “Customer advised that 3 rows of bristles fell off while in use.” ii) 2016-054512: From a Health Professional: “I am concerned about the sale of wire barbecue brushes throughout retail outlets across Canada. This has been a long standing concern among health professionals like myself and I believe it would be prudent for Health Canada to ban the sale of these products in Canada. Wires from barbecue brushes can break of [sic] and ultimately end up in people's food and cause serious injury. CBC recently ran a story about this issue to which I have added the link below. http://www.cbc.ca/news/health/barbecue-brushesdangers-swallow-throat-wire-bristle-dempsey-1.3741578” iii) 2016-055237: From Consumer: ”This is the first I heard of this story on CBC News and the week before it was published I bought and used a similar brush that I saw at [REDACTED] and [REDACTED]. I used the product and am only writing this because I got the thin wire in my steak and luckily I chewed and caught it before it was swallowed but many others are not so lucky. This product is made of plastic, the heat of the sun and BBQ wears down the plastic and the wires get loose… I saw my church even used this metal bristled on their BBQ…” iv) 2017-022968: From Importer: “Customer advised that a bristle from the BBQ brush got caught in his throat and he had to have it surgically removed.” As of July 24, 2017, a total of 40 reported cases were in the Health Canada database. A breakdown of these 40 cases are described as follows: - Prior to June 20, 2011 (i.e., the coming-into-force of the Canada Consumer Product Safety Act), there were 7 cases related to this product type in the Health Canada database, dated from 2004 to 2010. 4 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division - From June 20, 2011 to July 07, 2017, Health Canada received 9 additional reported incidents concerning this issue. - In recent weeks (July 2017), there has been increased media attention to this issue. From July 08 to July 24, 2017, 24 additional cases have been received by Health Canada. Of these 24 newly received incident reports (July 2017), it is noted that 9 of those incidents occurred in 2016 or earlier; that is, the consumer was only recently prompted to report the previously occurring incident. Reporting in United States and Europe: United States Consumer Product Safety Commission (US CPSC): http://www.saferproducts.gov/Search/default.aspx As of July 24, 2017, the US CPSC public database contained 25 cases, dated from May 2011 and September 2015. European Union Rapid Alert System: http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm The Risk Assessment Division conducted searches for non-North-American countries, including Europe, the United Kingdom, and Australia, all of which resulted in no information found regarding incident reports concerning this product type. Additional notes: 3.0 LEVEL 1 ASSESSMENT SUMMARY AND RECOMMENDATION 3.1 Incident Description As stated above, the reported incidents and general safety concern are related to the ingestion of metal wire bristle(s) which had detached or broken off a barbecue cleaning brush and subsequently had adhered to the food being cooked on the barbecue grill. Figure 4 illustrates a typical wire bristle which had released from a wire brush product. 5 of 22 2017-024723 Security – Classification: Protected B NOTE: CONFIDENTIAL INFORMATION REDACTED LEVEL 1 ASSESSMENT Risk Assessment Division Figure 4: Metal wire bristle detached/broken from barbecue brush, with ruler for scale. 3.2 Product History 3.2.1 Health Canada Incident Reports As of the writing of this risk assessment report, a total of 40 cases concerning this issue have been reported to Health Canada, dated from 2004 to July 24, 2017. Table 1 shows a breakdown of the cases in the Health Canada database in terms of incident description (i.e., anatomic location in which the ingested metal wire bristle had been located and any associated injury). Table 1: Breakdown of Cases Reported to Health Canada. Cases dated 2004 to July 24, 2017. Incident Description (i.e., Anatomic Location of Wire Bristle) Bristle(s) Seen/Detected Prior to Entering Mouth In Mouth In Throat In Esophagus In Stomach In Intestine No Incident, but rather General Concern of the Issue Totals Total Cases Injury 6 0 16 15 1 0 1 1 11 (see Note 1) 15 (See Note 2) 1 0 1 n/a 40 28 6 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division Note 1: 11 of the 16 "in mouth" cases resulted in an injury within the mouth. In the other 5 cases, the wire bristle was sensed/detected in the mouth and was removed prior to any injury occurring. Note 2: In 2 of the 15 "in throat" cases, when medical attention was sought for the reported injury to the throat, the wire bristle was no longer found in the throat area. That is, the wire bristle had reportedly already moved farther down the alimentary tract. In both of those cases the bristle eventually passed completely through and out the body. Of the 40 cases reported to Health Canada, the majority (34 cases) identified an adult as the person involved or injured. The remaining 6 cases involved children. In 4 of those 6 cases, the reported ages of the children ranged from 5 to 14 years; the other 2 cases did not report an age, only that it was a "child" involved. Of those 6 cases involving a child, 4 cases were "in mouth" (i.e., wire bristle in the mouth) and the other 2 cases were "in throat" (i.e., wire bristle in the throat). The following brands of barbecue brushes were identified in the cases reported to Health Canada: - [REDACTED]: 5 cases - [REDACTED]: 3 cases - [REDACTED]: 2 cases - [REDACTED]: 2 cases - [REDACTED]: 1 case - [REDACTED]: 1 case - [REDACTED]: 1 case - Unknown or unidentified brand: 24 cases Table 2 illustrates the distribution of the cases in the Health Canada database in terms of product brand and the incident description (i.e., anatomic location in which the ingested metal wire bristle had been located and any associated injury). 7 of 22 2017-024723 Security – Classification: Protected B NOTE: CONFIDENTIAL INFORMATION REDACTED LEVEL 1 ASSESSMENT Risk Assessment Division Table 2: Distribution of Product Brands in terms of Incident Description (Anatomic Location of Wire Bristle) for Cases Reported to Health Canada. Cases dated 2004 to July 24, 2017 Incident Description (i.e., Anatomic Location of Wire Bristle) Bristle(s) Seen/Detected Prior to Entering Mouth In Mouth In Throat In Esophagus In Stomach In Intestine Product Brand [REDAC TED] [REDACTE D] 2 1 2 2 [REDAC TED] [REDAC TED] 1 1 [REDAC TED] [REDAC TED] [REDA CTED] 2 1 1 1 (unknown) 1 1 11 10 1 1 Based on the results shown in Table 2, it is the opinion of the Risk Assessment Division that there is no noticeable pattern relating the brand of barbecue brush and the severity of injury. The wire bristles from several brands were "seen/detected prior to entering mouth," including the brands [REDACTED], [REDACTED], and [REDACTED]. However, those same three brands were also involved in other reported incidents in which the bristle had entered an individual’s mouth. In addition, there was no evidence to indicate that bristles from any one brand tended to travel farther down the alimentary tract compared to other brands. In summary, it is the opinion of the Risk Assessment Division that the particular brand of the brush from which the bristle originated would likely have negligible influence on the ensuing potential incident. 3.2.2 U.S. Consumer Product Safety Commission Incident Reports As of July 24, 2017, the US CPSC public database (www.saferproducts.gov) contained 25 reported cases, dated from May 2011 to September 2015. Table 3 is a similar table as Table 1, which shows a breakdown of those US CPSC reported cases in terms of incident description (i.e., anatomic location in which the ingested metal wire bristle had been located and any associated injury). 8 of 22 2017-024723 Security – Classification: Protected B NOTE: CONFIDENTIAL INFORMATION REDACTED LEVEL 1 ASSESSMENT Risk Assessment Division Table 3: Breakdown of Cases Reported to US CPSC. Cases dated May 2011 to September 2015 Incident Description (i.e., Anatomic Location of Wire Bristle) Bristle(s) Seen/Detected Prior to Entering Mouth In Mouth In Throat In Esophagus In Stomach In Intestine No Incident, but rather General Concern of the Issue Totals Total Cases Injury 4 0 9 5 2 0 5 0 7 (see Note 3) 5 2 0 5 n/a 25 19 Note 3: 7 of the 9 "in mouth" cases resulted in an injury within the mouth. In the other 2 cases, the wire bristle was sensed/detected in the mouth and was removed prior to any injury occurring. Of the cases reported to the US CPSC, the following brands of barbecue brushes were identified: - [REDACTED]: 4 cases - [REDACTED]: 5 cases - [REDACTED]: 3 cases - [REDACTED], [REDACTED], [REDACTED], [REDACTED], [REDACTED], [REDACTED], [REDACTED], [REDACTED], [REDACTED], [REDACTED], [REDACTED], [REDACTED], [REDACTED]: 1 case each 3.2.3 Information Reported by Medical/Scientific Community 3.2.3.1 Review of eCHIRPP and NEISS Records 1. eCHIRPP (Canada) In Canada, the Canadian Hospital Injury Reporting and Prevention Program (CHIRPP) is a database maintained by the Public Health Agency of Canada (PHAC), which collects and analyzes data on injuries to people who are seen at Emergency Departments of 17 select hospitals across Canada. The 17 CHIRPP hospitals consist of 11 pediatric hospitals and 6 general hospitals. 9 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division The Surveillance and Triage Unit of the Consumer Product Safety Directorate (CPSD) requested a search of the eCHIRPP database, specifically related to barbecue brush injuries, between January 1, 2011 and July 17, 2017. The eCHIRPP search resulted in the identification of [REDACTED] for this 6-1/2 year time frame. It is further noted that there was insufficient detail provided in the eCHIRRP search results to identify whether any of these eCHIRPP cases were among the cases that had also been reported to Health Canada. Of the [REDACTED] eCHIRPP cases, [REDACTED] had an anatomic location recorded, as follows: [REDACTED]. It is noted that the alimentary tract consists of the entire gastrointestinal system from the mouth through to the rectum. No further breakdown was provided in the eCHIRPP data. It must be noted that CHIRPP data cannot be extrapolated to the overall Canadian population with any reliable accuracy, as it will produce an under-representation regarding adults in general and rural inhabitants overall [ref 1]. 2. NEISS (United States) In the United States, the National Electronic Injury Surveillance System (NEISS) is a database, maintained by the US CPSC, is designed to monitor product-related injuries which were presented to the Emergency Departments of 100+ participating U.S. hospitals. Regarding NEISS data, it is possible to perform mathematical calculations in order to determine estimated case totals nationwide for the U.S. [ref 2]. Baugh et al. (2016) [ref 3] conducted a review of NEISS data specifically related to wire bristle grill brushes for the years 2002 to 2014, inclusive. The results of their search produced 43 cases in the NEISS database. It was observed by the authors that there was a seasonal peak in terms of incidence rate, with the summer months (June, July, August) having the highest number of events. It was further noted that there was an observed increase in the NEISS cases within the final 2 years of the study (i.e., 22 of the 43 total cases were reported in 2013 and 2014); however, the authors did not comment regarding any causes of the observed increase. The authors performed calculations using the NEISS data, which resulted in an estimated nationwide total of 1698 such cases for the U.S. between 2001 and 2014 (i.e., annual estimated average of approximately 131 U.S. cases nationwide). Regarding medical treatment, 30 of the 43 NEISS patients were examined/treated and released, 12 patients were held/treated/admitted, and the 1 other patient was not recorded. 10 of the 43 NEISS 10 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division cases did not record anatomic location of injury; however, of the other 33 NEISS patients, the most common injury (23 cases) occurred in the oropharanx (i.e., throat, tonsil, pharynx area). The remaining 10 NEISS cases were distributed as follows: 3 involving the oral cavity (i.e., mouth, tongue palate), 1 in the larynx, 4 in the esophagus, 1 in the stomach, and 1 in the intestine [ref 3]. 3.2.3.2 Communication from Medical Professionals On August 31, 2016, the Canadian Broadcasting Corporation (CBC) posted an article on the reported safety issue concerning bristle barbecue brushes, including an interview with otolaryngologist, Dr. I. Dempsey. In the article the CBC stated that, "Hospitals in the Halifax area are seeing at least one to two cases each week, he said, adding that many of the wires can be removed by emergency room physicians but a few ‘get deeper in and lower down’ and require surgery." [ref 4] Health Canada has not been able to access any data to substantiate this statistic. On May 3, 2017, a product safety officer from [REDACTED]contacted [REDACTED] for [REDACTED] information. [REDACTED] stated that [REDACTED] had previously dealt with [REDACTED] incidents with barbecue brush bristles in one summer. Regarding the cases seen in [REDACTED] practice, the bristle is typically embedded in the back of the tongue/throat area, which according to [REDACTED] would generally not be deemed to be life threatening. [REDACTED]added that, [REDACTED]. Further to the information provided by [REDACTED], the Risk Assessment Division inquired with the [REDACTED] for additional information. The same product safety officer from [REDACTED] communicated with [REDACTED]. [REDACTED] stated [REDACTED] is aware of this issue [REDACTED]. [REDACTED]. Another item found was an article from the Canadian Broadcasting Corporation (CBC), dated July 07, 2017 [ref 5]. In that article, emergency physician, Dr. L. Francescutti, indicated that an ingested metal bristle could potentially make its way through to the intestine and potentially tear a hole in the intestine. Dr. Francescutti then described a condition called, peritonitis. In the article the CBC stated that, "In severe cases, he said, peritonitis can be fatal." [ref 5] 3.2.3.3 Review of Other Articles In a limited search of the literature, two (2) medical articles were found which discuss medical cases involving a metal wire bristle from a barbecue brush having been ingested by an individual and requiring medical extraction [refs 6, 7]. In one article, the wire bristle was lodged in the throat [ref 6], and in the 11 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division other article the wire bristle had travelled to the intestine (duodenum) and had penetrated into the duodenal wall extending into the adjacent pancreatic neck (pancreas) [ref 7]. The medical professional involved in the intestine/pancreas case was later interviewed in a media article [ref 8]. Both of these medical professionals stated that a single metal bristle is difficult to be seen or accurately identified on an x-ray. In both of those cases, it was not until the bristle was visually verified (either by scope camera, or during surgery itself) that the object was in fact identified as a metal bristle [refs 6, 8]. 3.2.4 Summary of Information Regarding Product History Health Canada has received more reported incidents regarding wire bristle barbecue brushes than the US CPSC; however, more than half of the Health Canada incident reports were received in July 2017, the same month as all the media attention. In both countries’ databases of reported incidents, a small proportion of reported incidents indicated that a wire bristle was seen/detected prior to the bristle entering an individual’s mouth. However, in the majority of the reported incidents, the wire bristle was not seen/detected, and the bristle entered a person’s mouth as they were ingesting food. Reported incidents indicate that the majority of the wire bristles ingested by individuals lodge either in their mouth or in their throat. In the mouth, a person may sense/detect the presence of a wire bristle and remove it prior to any injury occurring. However, once the person swallows the wire bristle and the bristle reaches the throat or farther along the alimentary tract, an injury may occur. There a small number of reported incidents in which the wire bristle had travelled fully to the intestine. Regarding those cases, medical professionals have indicated that a puncture injury in this area of the body may be life-threatening, and removal of such a wire bristle has required major surgery. 3.3 Applicable Regulations & Standards There are no regulations that apply to this product category. There are currently no mandatory or voluntary standards regarding this product category. 12 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division 3.4 Industry Reporting 3.4.1 Product Testing by Companies Among the incident reports and other correspondence received by Health Canada, two companies ([REDACTED], and [REDACTED] (i.e., [REDACTED] brand)) provided test reports, or an excerpt thereof, regarding their respective barbecue brush products. In both cases, in-house laboratory test methods had been developed for the respective companies, primarily to verify product quality, rather than safety compliance testing. The testing as reported by these two companies is found in the Attachments of this risk assessment report. [REDACTED] conducted the following mechanical performance testing: [REDACTED] provided the results of their mechanical scrubbing testing. Direct Pull Force Test ([REDACTED]) The resulting pull-out force to remove a full tuft of metal bristles was [REDACTED]. There was no notation to indicate any pull force testing being performed on single, individual wire bristles. To provide context regarding this pull force testing, the Risk Assessment Division found published human strength data (see Table 4) which indicated average one-handed push/pull strength values for adult females and males [ref 9]: Table 4: Average (Mean) One-Handed Strength Values of Adults for Push and Pull Arm Actions, gripping a horizontal cylindrical bar. [ref 9] Age Group 21-30 years 31-50 years 51-60 years Mean PUSH Strength Females Males 255 N 409 N 295 N 477 N 191 N 305 N Mean PULL Strength Females Males 341 N 452 N 314 N 457 N 278 N 347 N Based on this published strength data, the average one-handed push/pull strength capacity for adults is greater than the pull-out force to remove a full tuft of metal bristles from the [REDACTED] product samples (factors ranging from [REDACTED] times as great). This result shall be discussed further in Section 3.5.2 of this risk assessment report. 13 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division Mechanical Scrubbing Test (both companies) Both companies performed their own version of a mechanical scrubbing test. In the [REDACTED] Limited testing, the product was mounted and forced against a grinding wheel apparatus, in which the grinding surface resembled the grated texture of a barbecue grill. The [REDACTED] testing applied a forceful back-and-forth scrubbing action of the product against an actual grate of a grill. In the opinion of the Risk Assessment Division, each test appeared to be a reasonable representation of a forceful realworld scenario of product usage. The results of the mechanical scrubbing tests were as follows: - [REDACTED] - [REDACTED] Due to the differences in the test methods employed by the two companies, there was no means of directly comparing the test results. 3.4.2 Barbecue Usage Statistics In the U.S., the Hearth, Patio & Barbecue Association (US HPBA) publishes statistics regarding barbecue usage rates. The Risk Assessment Division was unable to find comparable data regarding barbecue usage statistics for Canada; however, given the societal similarities between the two countries, the US HPBA data is considered a reasonable representative estimate of barbecue usage in Canada. From the 2015 study by the US HPBA, 75% of adults are reported to own a grill or smoker [ref 10]. Further information was found in an earlier edition (1997) of the same US HPBA association (at that time the association was reportedly called the Barbecue Industry Association). In that 1997 study, the following information was provided [ref 11]:  75% of households own a barbecue grill (corroborating the 2015 statistic above).  84% of family households (i.e., multiple-person households) own a barbecue grill, compared to only 57% of non-family households (i.e., single-person households).  Families with children barbecue more often. 14 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division   Over 50% of grill owners barbecue 4+ times per month. Cleaning brushes were among the top 4 accessories owned by barbecuers (along with tongs, and long-handled forks and spatulas). This reported information is relevant, as it provides an indication of the prevalence of barbecues among the overall population, and hence the associated prevalence of wire bristle brushes. 3.5 Issue Evaluation 3.5.1 Pathway to Injury Based on the reported statistics regarding barbecue usage, the majority of Canadians (children and adults) are likely exposed to food that had been prepared on a barbecue grill at least some time over the course of a year, likely during the summer months. The usage statistics further indicate that many households with a barbecue will also have a brush for cleaning the grill as well. As a result, it can be concluded that a large proportion of the overall Canadian population would, at some point in time, ingest food that had been prepared on a barbecue grill which was previously cleaned by a wire brush. Regarding the reported incidents received by Health Canada (and similarly for those received by the US CPSC), a small proportion of reported incidents described the fact that a wire bristle was seen/detected prior to the bristle entering an individual’s mouth; however, for the majority of the reported incidents, the wire bristle was not seen/detected beforehand, and the bristle entered a person’s mouth as they were ingesting food. The fact that the individuals did not visually observe the presence of a detached/broken wire bristle on the barbecue grill, or subsequently adhered to the food, indicates that the general public may not be aware of the possibility that a wire bristle might be present on barbecued food, and therefore may not think to examine their food prior to eating. Once a wire bristle enters a person’s mouth, the event pathway involves the following sequence: First, while the wire bristle is in the mouth, the individual may sense/detect the presence of the bristle and remove it prior to any injury occurring. However, there are documented cases in which the wire bristle becomes lodged in the mouth (e.g., tongue, palate), causing injury. Subsequent to that, if the person does not detect the wire bristle in the mouth, they will swallow the bristle along with the mouthful of food. Once swallowed, the bristle may lodge in the throat; however, there are documented cases in which the wire bristle has travelled past the throat, farther along the alimentary tract, becoming lodged in the intestine or in an abdominal organ (e.g., pancreas). Regarding 15 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division those cases, a puncture injury if it occurs in those body locations may be life-threatening. Although passage entirely through the gastrointestinal system without incident is possible, it is the opinion of the Risk Assessment Division that every incident of swallowing a metal wire bristle would constitute a potentially severe or life-threatening circumstance. 3.5.2 Interpretation of Product Testing Results As described in Section 3.4.1, [REDACTED] reported that they performed direct pull force testing regarding a full tuft of metal bristles. The average pull force to remove a tuft of bristles [REDACTED]. It was further determined from published strength data, that the average one-handed push/pull strength capacity for adults is greater than the reported pull-out force of a tuft of bristles, by a factor [REDACTED]. It is reiterated that there were no reported test results regarding the pull force for a single individual bristle of the brush. In the opinion of the Risk Assessment Division, a single wire bristle would pose a greater potential hazard, compared to a full tuft of bristles, because of the greater likelihood that a full tuft of bristles could be visually seen/detected due to its greater size. The documented cases involving a single wire bristle indicate that actual usage circumstances, on occasion, can cause a single bristle to detach or break away from a barbecue cleaning brush. That is, during the push/pull motion of cleaning a barbecue grill, if a single wire bristle was to snag against the grill for whatever reason, the documented cases indicate that the bristle could possibly detach or break off from the brush. If this was to happen, the wire bristle may remain on the grill, as the cleaning action may have moved to a different location along the grill surface. This detached/broken wire bristle could then be exposed to food which will be placed on the grill in the future. 3.5.3 Product Warning Labels An informal, random check of wire barbecue brushes available at a large retailer found that most barbecue brushes with wire bristles included a warning worded exactly as the examples illustrated on page 2 of this risk assessment report. It is the opinion of the Risk Assessment Division that such a warning affixed to the brush would provide at least some level of safety reminder to the person barbecuing, if heeded each time the brush is used. However, there were also products that did not have warnings attached to the product; rather, the warning sticker was found inside the shipping box. In the opinion of the Risk Assessment Division, a 16 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division warning label in the shipping box would not provide any consistent safety reminder once the product is removed from the packaging. One of the observed product samples was constructed such that the entire matrix of wire bristles was attached to a separate, replaceable pad, and this pad of bristles is inserted into the brush head. It was observed that the warning label was affixed to the back of the pad of bristles, which means that once the pad is inserted into the brush head prior to first use, the warning label would then be permanently obscured for the life of the pad. 3.5.4 Alternative Products: Barbecue/Grill Cleaning Products Without Metal Wire Bristles An internet search was conducted regarding available products for cleaning barbecue grills. The following products were found which do not employ metal wire bristles:     Brush with Nylon bristles Brush with "natural fibre" bristles Abrasive scrubbing blocks Wood scraper Consumer reviews were found concerning each of these alternative products. Brush with Nylon Bristles As of the writing of this risk assessment report, no product reviews were found regarding nylon bristle barbecue cleaning brushes. However, in the opinion of the Risk Assessment Division, even if a nylon bristle brush also had the potential tendency to lose nylon bristles onto the barbecue grill, the possibility of ingestion of a nylon bristle will likely have a substantially less severe adverse health effect, compared to an ingested metal wire bristle. A nylon bristle would likely be more flexible and also less sharp than a metal wire bristle, and there would likely be less potential for injury within the alimentary tract. Furthermore, there would also be an associated greater likelihood that a nylon bristle could pass completely through the body without injury. 17 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division Brush with "Natural Fibre" Bristles For this product type, no product reviews regarding "natural fibre" bristle barbecue cleaning brushes were found. The retailer did not indicate the identity of the "natural fibre" material. However, if this "natural fibre" bristle was more flexible and also less sharp than a metal wire bristle, again the possibility of ingestion of a "natural fibre" bristle will likely have substantially less severe adverse health effect, compared to an ingested metal wire bristle. Abrasive Scrubbing Blocks Figure 5a: [REDACTED] brand Figure 5b: [REDACTED] brand Figure 5: Two product examples of abrasive scrubbing block for cleaning a barbecue grill Two brands of abrasive scrubbing block for the purpose of cleaning a barbecue grill were found: [REDACTED] (Figure 5a), and [REDACTED] (Figure 5b). Both products are described as a hand-held block of hard, abrasive material. The actual product material of the [REDACTED] brand product is currently unknown. Several retailer websites state only that the product is [REDACTED] [ref 12] Consumer reviews of the product included [REDACTED] individuals reporting that the product leaves a gritty residue. [ref 13] The product material of the [REDACTED] brand product is indicated as being a [REDACTED] [ref 14] Of [REDACTED] consumer reviews [REDACTED] [ref 15] 18 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division In the opinion of the Risk Assessment Division, a gritty residue deposited on the barbecue grill likely would also adhere to food being cooked, resulting in the same potential to be ingested. However, any grit or granules from a stone-like material will likely have less potential to pierce or cut soft tissue in the human alimentary tract, compared to the sharp metal wire bristles of a barbecue brush. As a result, it is the opinion of the Risk Assessment Division that abrasive scrubbing blocks would likely be a safer alternative for cleaning a barbecue grill, as compared to metal wire bristle brushes. Wood Scraper Figure 6: Example of Wood Scraper product for cleaning a barbecue grill This product type (Figure 6) is described as a solid wood, paddle-shaped product. The paddle end reportedly develops a grooved profile as the product is used over time (i.e., the grooves adapt to the shape and spacing of the barbecue grill). On one retailer website, there [REDACTED] negative reviews typically focused on the quality of the wood or the sub-optimal grill-cleaning performance. There was no mention in any of the negative reviews regarding any material from the scraper being left on the grill. [ref 16] In the opinion of the Risk Assessment Division, there is evidence to indicate that a wood scraper would likely be a safer alternative for cleaning a barbecue grill, as compared to metal wire bristle brushes. 19 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division 3.6 Conclusions & Recommendations Based on the reported statistics regarding barbecue usage, the majority of Canadians are likely exposed to food that had been prepared on a barbecue grill at least some time over the course of a year, likely during the summer months. This includes children as well as adults. Most of those individuals could be exposed to food from a barbecue 4+ times per month (likely in the summer months only). The usage statistics further indicate that many households with a barbecue will also have a brush for cleaning the grill as well. Although many wire bristle barbecue brushes are equipped with safety warnings, not all of them have such labels affixed for prominent, regular display to the person using the product. There is an indication that the general public may not be aware of the possibility that a wire bristle may be present on barbecued food, and therefore may not think to examine their food prior to eating. If a wire bristle has entered the mouth of a person while eating, once the person swallows the wire bristle, this would likely result in an injury occurring. Regarding any incident in which a wire bristle is swallowed, there exists the potential for the bristle to travel down the alimentary tract to the intestine or possibly an abdominal organ. The wire bristle could potentially pierce or cut any soft tissue that it encounters. Although passage entirely through the gastro-intestinal system without incident may be possible, it is the opinion of the Risk Assessment Division that every incident of swallowing a wire bristle would constitute a potentially severe or life-threatening circumstance. There are several different types of alternative products used for cleaning a barbecue grill, all of which in the opinion of the Risk Assessment Division are likely safer alternatives compared to metal wire bristle brushes. Aside from anecdotal consumer reviews, it is not clear whether these products perform as well as a metal wire brush. Regarding metal wire bristle barbecue brushes, the documented cases indicate that a wire bristle can, on occasion, detach or break away from the product. If the detached/broken bristle was to remain to the barbecue grill, and not be observed by the person barbecuing, there exists the possibility that the bristle might then adhere to the food being cooked. If ingested, a metal wire bristle could potentially pierce or cut any soft tissue in the human alimentary canal. Based on the documented cases, this phenomenon is not limited to any specific brand(s) of wire bristle barbecue brush; that is, the particular brand of the brush from which the wire bristle originated would likely have negligible influence on the ensuing potential incident. 20 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division The Risk Assessment Division recommends this case be assigned to Risk Management Bureau for consideration and review. Note: The recommendations made in this report are based on the information that was available at the time the report was written. This report does not imply Health Canada’s approval, authorization or endorsement of this product or product category. Should new information become available or new incident reports arise, this issue may be re-evaluated. Workflow Action(s): 4.0 ☐ ☒ ☐ ☐ ☐ Proceed to further assessment Assign to Risk Management Bureau Add to Surveillance’s “Watch List” RA case complete and advise RMB and Region (as applicable) of outcome Other (specify): ATTACHMENTS [REDACTED] [REDACTED] 5.0 REFERENCES 1. Public Health Agency of Canada (PHAC), Canadian Hospitals Injury Reporting and Prevention Program, http://www.phac-aspc.gc.ca/injury-bles/chirpp/index-eng.php, Accessed July 21, 2017. 2. United States Consumer Product Safety Commission (US CPSC), NEISS Data Highlights - 2010, https://www.cpsc.gov/s3fs-public/pdfs/blk_media_2010highlights.pdf, Accessed July 22, 2017. 3. Baugh, T.P., Hadley, J.B., and Chang, C.W.D., Epidemiology of Wire-Brush Grill Brush Injury in the United States – 2002-2014, American Academy of Otolaryngology – Head and Neck Surgery, 2016, Vol. 154 (4), pp. 645-649. 4. Canadian Broadcasting Corporation (CBC), Canadian surgeons urge people to throw out bristle BBQ brushes, 2016, http://www.cbc.ca/news/health/barbecue-brushes-dangers-swallowthroat-wire-bristle-dempsey-1.3741578 21 of 22 2017-024723 NOTE: CONFIDENTIAL INFORMATION REDACTED Security – Classification: Protected B LEVEL 1 ASSESSMENT Risk Assessment Division 5. Canadian Broadcasting Corporation (CBC), Toss metal BBQ brush – Alberta mom warns after hospital trip, 2017, http://www.cbc.ca/news/canada/edmonton/edmonton-whitecourt-bbqbristle-brush-hospital-emergency-1.4193970 6. Baylis, J. and Balfour, N., Barbecue blunder: a case report of ED removal of a pharyngeal wire bristle foreign body, American Journal of Emergency Medicine, 2016, Vol. 34 (7), p. 1328. 7. Gaszynski, R., and Zhu, K.J., Summer danger: penetrating pancreatic injury from barbecue wire bristle, ANZ Journal of Surgery, 2017, n/a. 8. Australian Broadcasting Corporation, Wire barbecue brush bristle injures man’s pancreas: doctors warn people to ‘grill with caution’, 2017, http://www.abc.net.au/news/2017-0513/barbecue-brush-bristle-injures-mans-pancreas/8516800 9. U.K. Department of Trade and Industry, Strength Data for Design Safety - Phase 1, 2000, p. 34. 10. Hearth, Patio & Barbecue Association, 2015 State of the Barbecue Industry Report, as cited in: http://www.prweb.com/releases/2015/12/prweb13117572.htm, Accessed July 23, 2017. 11. Barbecue Industry Association, 1997 Survey Results & Barbecue Trends, as cited in: Barbecue’n On The Internet, http://www.barbecuen.com/bbqstats.htm#axzz4nfG0OCD9, Accessed July 23, 2017. 12. https://www.amazon.ca/[REDACTED], Accessed July 26, 2017. 13. https://www.amazon.ca/[REDACTED], Accessed July 26, 2017. 14. https://www.amazon.ca/[REDACTED], Accessed July 26, 2017. 15. https://www.amazon.ca/[REDACTED], Accessed July 26, 2017. 16. https://www.amazon.ca/[REDACTED], Accessed July 26, 2017. 22 of 22 2017-024723