Review of refractory ceramic fiber (RCF) toxicity, epidemiology and occupational exposure

Figures & data

Figure 1. Weighted half-times (days) in the pulmonary region for amphibole asbestos and selected SVFs (Greim et al., 2014; Hesterberg et al., 1998; Maxim et al., 2006).

Figure 2. Time trends in weighted average TWA fiber concentrations at RCF manufacturers and customers (Everest Consulting Associates, 2017).

Figure 3. Graphs demonstrate cumulative exposure avoided by implementing the PSP program versus continued uncontrolled exposure at 1990 levels for manufacturer plants (left) and customers (right). Source: Everest Consulting Associates (2017).

Table 1. SMRs and confidence intervals for full cohort (N = 1119) and most exposed group, abbreviated version, SMRs significantly elevated or reduced shown in boldface, excerpted from LeMasters et al. (2017).

Group	Full cohort (N = 1119)			>45 fiber-months/cc (N = 285)
Cause	Observed deaths	SMR	95% CI	Observed deaths	SMR	95% CI
All causes	234	0.73	0.64–0.83	93	0.79	0.64–0.97
All cancers	74	0.86	0.68–1.09	31	1.01	0.68–1.43
MN respiratory	24	0.83	0.53–1.24	8	0.75	0.32–1.48
MN trachea, bronchus, lung	23	0.83	0.53–1.25	8	0.78	0.34–1.55
MN urinary organs	8	1.80	0.78–3.55	6	3.62	1.33–7.88
MN kidney	4	1.72	0.47–4.39	3	3.60	0.74–10.52
MN bladder and other urinary	4	1.90	0.52–4.86	3	3.64	0.75–10.65
MN other & unspecified site	9	0.74	0.34–1.41	3	0.71	0.15–2.06
MN mesothelioma	1	2.86	0.07–15.93	1	7.85	0.20–43.76
MN lymphatic and hematopoietic	11	1.32	0.66–2.36	4	1.32	0.36–3.37
Leukemia	8	2.51	1.08–4.94	3	2.57	0.53–7.50
Benign and unspecified MN	1	0.94	0.02–5.26	0	0.00	0.00–9.67
Heart diseases	64	0.75	0.58–0.96	22	0.66	0.41–1.00
Other dis. circulatory system	15	0.68	0.38–1.13	5	0.59	0.19–1.39
Diseases respiratory system	25	1.01	0.65–1.49	12	1.26	0.65–2.20
Dis. genito-urinary system	2	0.35	0.04–1.26	1	0.47	0.01–2.60
Other and unspecified causes	8	0.76	0.33–1.50	2	0.57	0.07–2.06

NMN: malignant neoplasms; SMR: standardized mortality rates.

Table 2. Studies addressing links between exposure to man-made mineral fibers and either non-malignant or malignant kidney or bladder disease.

Increase in kidney or bladder disease	Stud y type	Population and dust/fiber exposure	Results	References
Yes	Cohort	2557 male workers in glass wool plant in Ontario, Canada.	The number of kidney cancers was nearly double that expected, both for plant-only and all workers. For the whole cohort, the 14 cases represented a significant excess (SIR =1.92; 95% CI [1.05, 3.21]). Study did not correct for smoking. Mortality from nephritis and nephrosis was significantly increased. Goldsmith & Goldsmith (1993) explored this issue by reviewing other literature and concluded that silica was likely to be the cause of the excess renal disease. Earlier study published 1984 showed cancer of genitourinary organs for plant only and total cohort of: Plant only: SMR =1.61; 95% CI [0.41, 4.39] and total: SMR =1.84; 95% CI [0.58, 4.43].	Shannon et al. (1984, 2005)
Yes	Case–control	Large hospital-based (CEERCC) study of renal cancer conducted across four Central and Eastern European countries.	Among participants ever exposed to dusts, significant associations with renal cell carcinoma (RCC) were observed for glass fibers (OR =2.1; 95% CI [1.1, 3.9]) mineral wool fibers (OR =2.5; 95% CI [1.2, 5.1]) and brick dust. Significant trends were observed with exposure duration and cumulative exposure.	Karami et al. (2011)
No	Cohort	5369 workers in mineral wool plant in Denmark.	Authors reported increase in cases of bladder cancer only among workers with ≥20 years since first employment. (4 bladder cancer cases compared to 1.6 expected O/E = 2.5; exact 95% CI [0.79, 6.03].) (p value reported in article 0.06 based on Chi-square test, improved p values are 0.1025 Mid-p exact tests or 0.1576 Fisher exact test.) No excess in kidney cancer found.	Olsen & Jensen (1987)
No	Case–control	Montreal multi-center of (inter alia) 100 kidney and 300 bladder cancer cases (1979–1983).	Study reported ORs for “synthetic fibers” [interpreted by Karami et al. (2011) to include glass and mineral wool] and kidney cancer OR =0.8; 95% CI [0.2, 2.8] and bladder cancer OR 1.6; 95% CI [0.9, 3.0]. Additional result for cases with substantial exposure (>15 years) for bladder cancer with borderline significance OR =2.1; 95% CI [1.0, 4.4].	Siemiatycki et al. (1986)
No	Cohort	Cohort of 941 workers in the glass wool producing industry in Finland was followed for deaths in 1953–1981.	SIR for bladder cancer =1.09; 95% CI [0.03, 6.06]. Kidney cancer included in “other” category with non-significant SIR.	Teppo & Kojonen (1986)
No	Cohort	3749 workers employed for at least 3 months in two Finnish glass factories (cohorts A and B) were followed up for cancer in 1953–1986 through the Finnish Cancer Registry.	SIR for kidney cancer (both sexes) = 0.35, based on 3 observed and 8.6 expected; 95% CI [0.07, 1.02]. SIR for bladder cancer (both sexes) = 0.97. Based on 9 observed and 9.3 expected; 95% CI [0.44, 1.84].	Sankila et al. (1990)
No	Cohort	Mortality and cancer incidence was investigated among 2807 workers employed for least 1 year before 1972 at 11 Swedish companies manufacturing prefabricated wooden houses. A total of 1068 workers were exposed to MMVF used for insulation.	Mortality: Bladder cancer SMR =0.98; 95% CI [0.26, 2.50] Kidney cancer SMR =0.47; 95% CI [0.099, 1.38]	Gustavsson et al. (1992)
No	Cohort	3539 male and female workers in three Swedish plants producing SVFs followed from 1952 to 1990.	SMR for bladder cancer =1.27; 95% CI [0.48, 2.77]. SMR for kidney cancer =1.4; 95% CI [1, 7.9].	Plato et al. (1995)
No	Cohort	22,002 production workers in man-made vitreous fiber production plants in Denmark, Finland, Norway, Sweden, United Kingdom, Germany and Italy, from 1982 to 1990.	There was no significant SMR for bladder cancer in the total cohort, those with ≥1 year employment or when partitioned among rock/slag wool, glass wool or continuous filament. (Total deaths from bladder cancer in entire cohort 35, SMR =1.07; 95% CI [0.74, 1.48].)	Boffetta et al. (1997)
No	Cohort follow up	A cancer incidence follow-up was conducted among 3685 rock-slag wool (RSW) and 2611 glass wool (GW) production workers employed for 21 year in Denmark, Finland, Norway, or Sweden and the standardized incidence ratios (SIR) were calculated on the basis of national incidence rates.	SIRs and 95% CIs for kidney cancer: Total SIR =0.50; 95% CI [0.28, 0.83] Rock/slag SIR =0.50; 95% CI [0.23, 0.95] Glass wool SIR =0.50; 95% CI [0.18, 1.09] SIRs and 95% CIs for bladder cancer: Total SIR =1.06; 95% CI [0.80, 1.38] Rock/slag SIR =0.91; 95% CI [0.62, 1.29] Glass wool SIR =1.39; 95% CI [0.88, 2.08]	Boffetta et al. (1999)
No	Cohort	11,373 male workers were who were employed for at least 1 year in the production of rock or slag wool (RSW), glass wool (GW) and continuous filament (CF) in 13 factories from seven European countries.	Increasing trend in mortality from non-malignant renal diseases. However, SMRs were not significantly elevated.	Sali et al. (1999)
No	Case–control	47 cases of nephritis or nephrosis from Owens Corning mortality surveillance system.	In this analysis, there was no consistent relation between respirable fiber exposure and either nephritis or nephrosis.	Chiazze et al. (1999)

Pooling the SMRs (Fixed effects model, see Morfeld et al., 2016) based on only the cohort studies listed in this table leads to the following pooled SMRs and corresponding 95% exact confidence intervals (http://www.openepi.com/SMR/SMR.htm) for bladder cancer – SMR =1.18.0, 95% CI [0.98, 1.41] and kidney cancer SMR =0.894, 95% CI [0.701, 1.124]. Neither result provides statistical evidence of elevated SMRs.

Table A1. Known risk factors for kidney cancer.

Site	Risk factor	Comments	Sources
Kidney cancer	Cigarette smoking	Strong evidence from cohort, case–control and meta-analysis studies in several countries indicates tobacco (particularly cigarette) smoking is a major risk factor.	Brown et al., 2012; Chow & Devesa, 2008; Hunt et al., 2005; Janout & Janoutová, 2004; Karami et al., 2012; Lipworth et al., 2009; Ljungberg et al., 2011; McLaughlin et al., 2006; Moyad 2001; Orth, 1997; Pascual & Borque, 2008; Qayyum et al., 2012; Rubagotti et al., 2006; Weikert & Ljungberg 2010; Zeegers et al., 2000.
	Obesity	Strong evidence from several studies that elevated body mass index (BMI) is a risk factor for kidney cancer.	Anderson et al., 2015; Brown et al., 2012; Chow et al., 2000, 2010; Chow & Devesa, 2008; Janout & Janoutová, 2004; Karami et al., 2012; Lipworth et al., 2009; Ljungberg et al., 2011; Mariusdottir et al., 2016; McLaughlin et al., 2006; Moyad, 2001; Qayyum et al., 2012; Rubagotti et al., 2006; Song et al., 2014; Vucenik & Stains, 2012; Weikert & Ljungberg 2010.
	Drugs	Mixed evidence relating to certain analgesics and diuretics.	Chow et al., 2010; Ljungberg et al., 2011; Rubagotti et al., 2006.
	Medical conditions and treatments	Hypertension is known risk factor for kidney cancer. Certain other diseases implicated (e.g. end stage, chronic kidney disease and long term dialysis). There are others including genetic factors and a family history of kidney cancer. There is a possible link to history of diabetes mellitus.	Chow et al., 2000, 2010; Chow & Devesa, 2008; Janout & Janoutová, 2004; Karami et al., 2012; Lipworth et al., 2009; Ljungberg et al., 2011; Mariusdottir et al., 2016; McLaughlin et al., 2006; Moyad 2001; Pascual & Borque, 2008; Qayyum et al., 2012; Rubagotti et al., 2006; Russo, 2012; Weikert & Ljungberg 2010.
	Occupational	“Renal cell cancer generally is not considered an occupational disease” (Chow et al., 2010), but occupational exposure to several chemicals (e.g. benzene, benzidine, coal tar, soot, pitch, gasoline, trichloroethylene, tetrachloroethylene, various metals (lead, cadmium), poly-aromatic hydrocarbons and solvents) implicated as risk factors. Employment in several sectors (e.g. agriculture, coke and coal oven workers, computer manufacturing, drycleaners, painters, mechanics, roofers, shipbuilders and textile workers), but evidence is mixed.	Chiu et al., 2013; Chow et al., 2010; Heck et al., 2010; Hu et al., 2002; Karami et al., 2011; Kim et al., 2014; Ljungberg et al., 2011; Mariusdottir et al., 2016; Moore et al., 2010; Partanen et al., 1991; Pascual & Borque, 2008; Pesch et al., 2000; Rubagotti et al., 2006; USEPA, 2009, 2012.

Table A2. Known risk factors for bladder cancer.

Site	Risk factor	Comments	Sources
Bladder cancer	Cigarette smoking	Tobacco smoking is the best established risk factor for bladder cancer. Numerous review articles, epidemiological studies (e.g. cohort and case–control) and meta-analyzes indicate that there are statistically significantly elevated odds ratios and high population attributable risks associated with smoking.	Baris et al., 2009; Brown et al., 2012; Brownson et al., 1987; Burger et al., 2013; Cassidy et al., 2009; Freedman et al., 2011; Ghadimi et al., 2015; Golka et al., 2007; Hemelt et al., 2009; IARC, 2004; Olfert et al., 2006; Orth, 1997; Silverman et al., 2006; Zeegers et al., 2000
	Obesity	Strong evidence from meta-analyzes that obesity is also a major risk factor for bladder as well as kidney cancer.	Koebnick et al., 2008; Qin et al., 2013; Song et al., 2014; Sun et al., 2015
	Medical conditions and treatments	Chronic bladder infections and irritations, personal or family history of bladder cancer, Some medications and dietary supplements – pioglitazone (Actos), aristolochic acid (mainly from plants in the Aristolochia family) and cyclophosphamide therapy. Schistosomiasis.	Burger et al., 2013, Lewis et al., 2011; Mostafa et al., 1999; Travis et al., 1995; http://www.medicalnewstoday.com/articles/167077.php.
	Occupational	Cohort and case–control studies have shown that occupational exposure to several chemicals (e.g. arsenic, paint components, dry cleaning fluids, polycyclic aromatic hydrocarbons, aromatic amines, diesel exhausts, lubricating oils or greases, petroleum product or additives, tetrachloroethylene and aromatic amines) linked to bladder cancer – strength of evidence varies. Employment is certain sectors (e.g. agricultural workers, bartenders, blacksmiths, bus drivers, dyers, painters, hairdressers, leather workers, maintenance workers, mechanics, medical workers, metal workers, miners, rubber industry, textile workers, transportation equipment, truck and bus drivers and waiters) also linked to bladder cancer, but strength of the evidence varies.	Brown et al., 2012; Brownson et al., 1987; Burger et al., 2013; Cassidy et al., 2009; Clapp et al., 2008; Ghadimi et al., 2015; Golka et al., 2004, 2007; González et al., 1989; Harling et al., 2010; Khoubi et al., 2013; Kogevinas et al., 2003; Lynge et al., 2006; McLaughlin et al., 2006; Olfert et al., 2006; Reulen et al., 2008; Richardson et al., 2007; Scarselli et al., 2011; Serra et al., 2008; USEPA, 2012; Wu et al., 2007; Zeegers et al., 2001.

Table A3. Studies on irritant contact dermatitis and fiber exposure.

Type of article	Typical results/statement	Source(s)
Review articles	Summarize other research findings that indicate fibers with diameters greater than those of respirable size are more likely to cause skin irritation.	ATSDR (2004) Björnberg (1985) INSERM (1999) http://www.ipubli.inserm.fr/bitstream/handle/10608/192/?sequence =10. Lachapelle (1986, 2006) Possick et al. (1970) Sertoli et al. (1992) Skotnicki-Grant (2008)
Focus groups	Interviews with workers exposed to insulation materials that contain some mention of the role of larger diameter fibers.	Lundgren et al. (2014)
Patch or rubbing test results	Patches containing fibers applied to skin of test subjects indicating larger diameters are associated with greater skin response.	Eun et al. (1991) Stam-Westerveld et al. (1994)
Miscellaneous other studies	Coarse fibers account for irritation	Heisel & Hunt (1968) Minamoto et al. (2002) Patiwael et al. (2005)
Case reports	One or several cases of contact irritant dermatitis caused by fibers with diameters greater than those of respirable size.	Chang et al. (1996) Koh et al. (1992) Lee & Lam (1992) Sim & Echt (1996) Wang et al. (1993)
Epidemiological studies	Studies of groups of occupationally exposed workers showing large diameter fibers associated with skin irritation.	Hsieh et al. (2001) Kieć-Świerczyńska & Wojtczak (2000)
Medical texts	Glass fibers with diameters greater than ∼5 µm are more likely to cause skin irritation than smaller diameter fibers	Adams (1990) Rom & Markowitz (2004) Kanerva et al. (2013) Konzen (1987)

Table A4. Causes, contributing factors and risk factors for adult leukemia.

Category	Examples	References
Occupational	Exposure to benzene and certain other chemicals (e.g. ethylene oxide (b), formaldehyde (a), pesticides, herbicides, insecticides, embalming chemicals, toluene and xylene).	Adegoke et al., 2003: Brown et al., 1990; Costantini et al., 2008; Deschler & Lübbert, 2006; Glass et al., 2003; IARC, 2012; Rinsky, 1989; Rodriguez-Abreu et al., 2007; Schwilk et al., 2010; Smith & Zhang, 1998; Zeeb & Blettner, 1998; Zhang et al., 2009
	Electromagnetic fields	Floderus et al., 1993; Karakosta et al., 2016; Rodriguez-Abreu et al., 2007
	Radiation	Band et al., 1996; Deschler & Lübbert, 2006; Greaves, 1997; Karakosta et al., 2016; Leuraud et al., 2015; Richardson et al., 2015; Rodriguez-Abreu et al., 2007; Smith & Zhang, 1998; Zeeb & Blettner, 1998
Lifestyle-related	Smoking	Brownson et al., 1993; Danaei et al., 2005; Fernberg et al., 2007; Fircanis et al., 2014; Kane et al., 1999; Karakosta et al., 2016; Smith & Zhang, 1998; Wang et al., 2015
	Obesity	Calle et al., 2003; Castillo et al., 2012; Larsson & Wolk, 2008; Strom et al., 2009
	Diet	McDonald et al., 2001; Ross et al., 2002; Smith & Zhang, 1998
Environmental	Radon exposures in the home.	Henshaw et al., 1990
Medical procedures	Chemotherapy (certain drugs) and therapeutic radiation.	Aidan et al., 2013; Curtis et al., 1992; Deschler & Lübbert, 2006; Zeeb & Blettner, 1998
Genetic disorders	Down syndrome, Klinefelter syndrome, Patau syndrome, Ataxia telangiectasia, Shwachman syndrome, Kostman syndrome, Neurofibromatosis, Fanconi anemia and Li-Fraumeni syndrome.	Deschler & Lübbert, 2006; Zeeb & Blettner, 1998
Certain viral infections	Infection with the human T-cell lymphoma/leukemia virus-1 (HTLV-1) can cause a rare type of T-cell acute lymphocytic leukemia. Most cases occur in Japan and the Caribbean area. In Africa, the Epstein-Barr virus (EBV) has been linked to Burkitt lymphoma, as well as to a form of acute lymphocytic leukemia. In the US, EBV most often causes infectious mononucleosis (“mono”).	Matsuoka & Jeang, 2007; De Roos et al., 2013; Rodriguez-Abreu et al., 2007
Family history	Family history of leukemia or any cancer.	Karakosta et al., 2016; Rauscher et al., 2002

(a) Some reported associations are controversial, such as the relation between occupational exposure to formaldehyde and leukemia (Collins & Lineker, 2004; Heck and Casanova, 2004).

(b) IARC (2012) concluded that there is limited human evidence for the carcinogenicity of ethylene oxide.

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