Paying Attention to PAA

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17. ® Page 17 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 impinger containing a methyl - p - tolyl sulphide solutio n (of which the analysis yields the concentration of total acids, peroxyacetic acid and acetic acid, and peroxyacetic alone). From these results the concentrations of the different products can be inferred without interference. A special device composed of inert materials was designed for the generation of the controlled atmosphere. Buffering the peroxyacetic solution at pH 7 with a phosphate buffer allowed the generation of peroxyacetic acid atmospheres with negligible concentrations of acetic acid and hyd rogen peroxide. Peracetic Acid (CAS No 79 - 21 - 0) and its equilibrium solutions , JACC No. 40, Brussels Jan. 2001. In depth report summarizing the properties of peracetic acid solutions. Atmospheric Monitoring of P erace tic Acid on the Existing Caprolactone Plant Distillation Ho uses A and B Assessment of Resu l t s, McDonagh, J. (1997) Document No. EE970192.M01. Memorandum to R.A Haffington et al from J. McDonagh, Solvay Interox, Warrington, UK. Measured the airborne peracetic acid concentrations in two caprolactone distillation plants (PAA is used as part of this production process) over a three hour period. The PAA was measured as total peroxide (i.e. PAA + H 2 O 2 ) , but H2O2 was expected to be a minor component. PAA ranged from 0.5 yo 0.6 ppm and these were not considered immediately irritating, but would be unplea sant over an extended time. PAA concentrations of 0.13 to 0.17 ppm were considered tolerable and not unpleasant with no lacrimentation over 3 hours. McDonaugh recommended 0.15 ppm as the 8 hour occupational exposure limit for PAA. This concentration would be perceptible but not irritating or unpleasant. Cited in Acute Exposure Guideline Levels for Selected Airborne Chemicals:, Volume 8 ,

3. ® Page 3 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 * Breathing Peroxyacetic Acid can irritate the lungs causing coughing and/or shortness of breath. Higher exposures can caus e a build - up of fluid in the lungs (pulmonary edema), a medical emergency, with severe shortness of breath. Chronic Health Effects The following chronic (long - term) health effects can occur at some time after exposure to Peroxyacetic Acid and can last for months or years: Cancer Hazard * There is limited evidence that Peroxyacetic Acid causes cancer in animals. It may cause cancer of the lungs. * Many scientists believe there is no safe level of exposure to a carcinogen. Such substances may also have the potential for causing reproductive damage in humans. Reproductive Hazard * According to the information presently available to the New Jersey Department of Health and Senior Services, Peroxyacetic Acid has not been tested for its ability to affect reproduction. Other Long - Term Effects High or repeated exposure may affect the liver and kidneys. The probable human oral lethal dose is 50 to 500 mg/kg, or between 1 teas p oon and 1 oz for a 150 lb person. 4 Exposure Limits for Peracetic Acid ACGIH The ACGIH issued a threshold limit value of 0.4 ppm peracetic acid calculated as a 15 minute time weighted average in the spring of 2014 . 5 The ACGIH based its decision on the following data points summarized from ACGIH data sheets for PAA. 4 Sittig’s handbook of Pesticides and Agricultural Chemicals, by Stanley A. Greene. 5 2014 Guide to Occupational Exposure Values, ACGIH.

8. ® Page 8 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Passive Sampling for Peracetic Acid Vapor Simultaneous sampling of peroxyacetic acid and hydrogen peroxide in workplace atmospheres; HECHT G.; HERY M.; HUBERT G.; SUBRA I.; Annals of occupational hygiene ; 2004, vol. 48, no8, pp. 715 - 721 . ; http://www.ingentaconnec t00715 Note: This method is commercial available from SKC - niosh/methods.asp?IDNumber=2068 Obviously a passive method for detection of any gas will not provide any warning of a leak or give any information on how the gas concentration is changing over time as a continuous monitor will. Non - commercial Methods for Measuring PAA Vapor Concentrations European Chemical Industry Council Z Gesamte Hyg. 1987 Apr;33(4):209 - 11. [A photometric method for determining the concentrations of peracetic acid in indoor air and results of studies concerning the risk of occupational exposure] [Article in German] Bretschneider K, John D. http://www.ncbi.nlm Passive sampling of airborne peroxyacetic acid. Anal Chem. 2006 Sep 15;78(18):6547 - 55. Henneken H, Assink L, de Wit J, Vogel M, Karst U. Laboratory Methods for Liquid Peracetic Acid . In addition there are many laboratory me thods for the determination of peracetic acid in a mixture such as the two methods shown below: Hydrogen peroxide content (and peracid as peroxyacetic acid) is determined by an oxidation - reduction titration with ceric sulfate. After the endpoint of this ti tration has been reached, an excess of potassium iodide is added to the solution. The potassium iodide reacts with peroxyacids to liberate iodine, which is titrated with a standard solution of sodium thiosulfate.

25. ® Page 25 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Exposure Routes Public: - Occupational: [Occupational exposure to peracetic acid can occur through dermal contact and inhalation of vapour] Examples of European MRLs (mg kg - 1 ) Value: - Note: For the EU pesticides database click here Drinking Water MAC (μg l - 1 ) - - - Health issues: Carcino gen Endocr ine disrupt er Reproduc tion / developm ent effects Acetyl cholineste rase inhibitor Neurotoxi cant Respirat ory tract irritant Skin irrita nt Eye irrita nt - - - General human health issues [May cause severe gastrointestinal tract irritation and renal failure], [Vapours may cause dizziness] Handling issues [Unstable - may explode on heating], [Caustic and corrosive] : Yes, known to cause a problem

19. ® Page 19 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 average. Erythrocyte dimensions dropped b y 23 per cent, and relative crythrocyte suface increased by 13 per cent. The stab - nuclear and eosinophile granulocytes as well as the monocytes were also increased with significance throughout the experimental period. Significant deline in weight was recor ded from animals with longest exposure. Those changes were attributed primarily to damage to the pulmonary tissue by peracetic acid, contained in Wofasteril aerosol. Peracetic acid was found to cause continuous deterioration of the ratio of oxygen to carbo n dioxide in blood and tissue, and the consequence was compensatory rise in both oxygen transport and exchange capacity. d=184452&q=peracetic+exposure&uid=788901738&setcookie=yes P athologico - anatomical and histological studies with special reference to the tracheal mucus membrane of calves following exposure to an aerosol disinfectant ; Wesemeier H, Kühn M, Steiger A. ; WofasterilArch Exp Veterinarmed . 1981;35(1):31 - 8; [Article in Ger man] , Various morphological methods were used in examining calves, with the view to determining the action of Wofasteril, an aerosolic disinfectant, on their organism, particularly on their trachea. Calves were found to differ from animals with pneumonia and other pulmonary inflammations, in that no transformation and quality change occurred to the mucus of their tracheal goblet cells in response to peracetic acid. Pathologico - anatomic and histological alterations in various organs were not attributable ei ther to the disinfectant. A contribution is made to a more general description of the normal tissue structure, in that data are presented on the length, width, and number of goblet cells in the trachea of calf. US Approval of PAA a s a sterilant US Environmental Protection Agency, Office of Pesticide Programs, List A: EPA’s Registered Antimicrobial Products Registered with the EPA as Sterilizers, January 9, 2009. oppad001/list_a_sterilizer.pdf EPA approved as a pesticide 40 CFR 152.25 (a) EPA #63838 - 1 FDA approved for direct food contact 21 CFR 173.315 (fruits, vegetables) 21 CFR 173.370 (meat, poultry, seafood) FDA approved as sanitizer on food contact surfaces 2 1 CFR 178.1010 Approval for use in Canada http://dsp - - 6 - 2001 - 5E.pdf Tabulated Safety Information S DS for PAA

15. ® Page 15 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 using a comprehensive survey of current practices and decision processes in all hospitals in British Columbia. Of 95 hospitals, 64 ret urned surveys; 80% of these used high - level disinfection. Among user hospitals, 49% used glutaraldehyde alone and 51% had introduced alternatives. Concern about staff health was the most common reason for substituting, but this was frequently not considere d when choosing specific alternatives. Hospitals that involved occupational health, infection control or regional staff in high - level disinfectant decisions used glutaraldehyde alternatives less often. In most hospitals, it was difficult to find individual s who were knowledgeable about the use of disinfectants. Potential health effects associated with each type of high - level disinfectant were assessed by review of the published literature and available manufacturers' data along with qualitative structure - ac tivity relationship analysis. Results indicated that although all products irritate the skin and respiratory tract, OPA is a potential dermal and respiratory sensitizer but hydrogen peroxide and peracetic acid do not cause allergic reactions. Despite littl e being known about the risks to employees from glutaraldehyde alternatives, their use is widespread. The potential risks of all high - level disinfectants are serious; thus regulators and users are faced with important risk management decisions before and a fter they have been introduced into the workplace. em2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_SingleItemSupl.Pubmed_D iscovery_RA&linkpos=2&log$=relatedarticles&logdbfrom=pubmed Sodium hypochlorite ‐ , chlorine dioxide ‐ and peracetic acid ‐ induced genotoxicity detected by the Comet assay and Saccharomyces cerevisiae D7 tests ; Annamaria Buschini, Pamela Carboni, Mariangela Furlini, Paola Poli1 and Carlo Rossi; Mutagenesis (2004), Volume 19, Issue 2Pp. 157 - 162. Mutagenicity of drinking water is due not only to industrial, agricultural and urban pollution but also to chlorine disinfection by ‐ products. Furthermore, residual disinfection is used to provide a partial safeguard against low level contamination and bacterial re ‐ grow th within the distribution system. The aims of this study were to further evaluate the genotoxic potential of the world wide used disinfectants sodium hypochlorite and chlorine dioxide in human leukocytes by the Comet assay and in Saccharomyces cerevisiae strain D7 (mitotic gene conversion, point mutation and mitochondrial DNA mutability, with and without endogenous metabolic activation) and to compare their effects with those of peracetic acid, proposed as an alternative disinfectant. All three disinfectan ts are weakly genotoxic in human leukocytes (lowest effective dose 0.2 p.p.m. for chlorine dioxide, 0.5 p.p.m. for sodium hypochlorite and peracetic acid). The results in S.cerevisiae show a genotoxic response on the end ‐ points considered with an effect on ly at doses higher (5 ‐ to 10 ‐ fold) than the concentration normally used for water disinfection; sodium hypochlorite and peracetic acid are able to induce genotoxic effects without endogenous metabolic activation (in stationary phase cells) whereas chlorine dioxide is effective in growing cells. The Comet assay was more sensitive than the yeast tests, with effective doses in the range normally used for water disinfection processes. The biological effectiveness of the three disinfectants on S.cerevisiae prove d to be strictly dependent on cell ‐ specific physiological/biochemical conditions. All the compounds appear to act on the DNA and peracetic acid shows effectiveness similar to sodium hypochlorite and chlorine dioxide. Evaluating Occupational Health Risks Associated With Substitution Of High - Level Disinfectants In Hospitals ; Karen L. Rideout; MS Thesis, The University Of British Columbia, April 2003 Glutaraldehyde, a chemical associated with respiratory illness, has been used for

18. ® Page 18 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Liquid Chemical Sterilization Using Peracetic Aci d: An Alternative Approach to Endoscope Processing ; Wallace, C. G.; Agee, P. M.; Demicco, D. D.; ASAIO Journal June 1995 - Volume 41 - Issue 2, 41:151 - 154. Recurrent episodes of endoscope contamination with nontuberculous mycobacterium and Pseudomonas spe cies, coupled with employee concerns about exposure to 2% glutaraldehyde and the requirement for rapid scope turnover time, led to the investigation of an alternative method for endoscope processing. A prospective evaluation of 220 bronchoscopy procedures was carried out. Endoscope culture surveillance was performed twice a month for a 12 month period on all endoscopes. In addition, the deliberate inoculation of bronchoscopes with Mycobacterium gordonae was carried out. No indications of cross contamination were noted among the 220 bronchoscopy procedures after processing the scopes by the studied liquid chemical sterilization system using peracetic acid. Ongoing patient surveillance did not reveal any indications of cross contamination for nearly 15,000 pat ient diagnostic or surgical endoscopic procedures using instruments processed by this liquid chemical sterilization system. Twice a month for 12 months, bronchoscopes, colonoscopes, and gastroscopes were cultured for bacterium, fungi, and acid fast bacilli and showed no growth. Deliberate inoculation of bronchoscopes with M. gordonae showed the scopes were rendered sterile. No unusual occurrences of occupational chemical exposure were found in 11 individuals working with this liquid chemical sterilization s ystem. The peracetic acid based sterilization system studied proved to be an effective, safe, and economical alternative to the glutaraldehyde method. ilization_Using_Peracetic.5.aspx Fogging Trials with Tenneco Organics Ltd, (30 June 1986) at Collards farm ; J.A.L. Fraser and A. Thorbinson (1986) Solva y Interox, Warrington, UK. Fraser and Thorbinson conducted fogging studies in chicken houses using a 5% PAA blend to determine the atmospheric concentrations of peracetic acid/hydrogen peroxide at different distances from the fogger. Lacrimation was reported at 5 ppm, ext r eme discomfort at concentrations > 2.5 ppm and 2.0 ppm was considered unbearable in one instance and tolerable for 2 min in another. As the concentration fell from 2 ppm to < 0.5 ppm the physiological responses decreased from extreme discomfort of mucous membrane to mild discomfort at 0.5 to 1.0 ppm to no discomfort at < 0.5 ppm. No irritation to the chest occurred at anytime during this test. Fraser and Thorbinson report described in Acute Exposure Guideline Levels for Selected Airbo rne Chemicals:, Volume 8 . Mode of Action of Peracetic Acid Aerosols and Effects on Animal Organism . Heinze, W Werner, E, Fischer, R Monatshefte fuer Veterinaermedizin [MONATSH. VE TERINARMED.] . Vol. 36, no. 9, pp. 343 - 349. 1981. The effects of 0.39 per cent, 1.56 per cent, and 6.25 per cent Wofasteril 24 ultrasound aerosol (0.15, 0.6, and 2.5 per cent peracetic acid) on eleven groups of 440 female mice were studied, with reference b eing made to earlier experiments. The aerosols were allowed to act upon the animals five, ten, and 15 minutes a day over 29 days. Significant differences, not depending on time of exposure, were recordable only from the groups with highest aerosol concentr ation. Included in those differences were rise in both erythrocyte count and total haemoglobin by 67 or 54 per cent on average and rise in average haemoglobin levels in the individual erythrocytes by 27 per cent on 24 Wofasteril® E 400 , 40 % Peracetic Acid for the Food and Farming Industries.

13. ® Page 13 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 have been effected in the APA solutions activation and decanting phases (load and unloading) employees: six "automatic endoscope washer - disinfectors" evaluations and twelve "basins" measures, for all through the operation (around 15 - 20 minutes). Air monit oring was performed by using vials containing alkaline silica gels with methyl p - tolylsulfoxide (MTSO) (1 l/min) and subsequently analysis by high performance liquid chromatography techniques (HPLC) equipped with a UV detector. The environmental investigat ions have underlined that APA average values result inferior to the specific TLV - TWA (around 1/10) and it reaches the same conclusion in comparison with TLV - STEL (around 1/4). Besides, the APA exposure founded in all the examined structures results smaller in comparison to the previously glutaraldehyde evaluation. Experimental Study of Adverse Effects of Peracetic Acid Used as an Air Disinfectant on Expo sed People ; Zhou, Xiao - tao, Fan, LI - Rui, Tang, Fei; Journal of Environment and Health . Vol. 23, no. 3, pp. 228 - 230. May 2006 To evaluate the potential adverse effects of peracetic acid on exposed people when it was largely used as an air disinfectant in t he public area. 29 volunteers (14 males, 15 females) were enrolled to take part in the experiment. The indoor areas were disinfected with peracetic acid according to the Guideline to Control the Hospital Infection During the SARS Period issued by the Minis try of Health. 4 ml blood were collected from the volunteers to determine the blood routine indexes, liver function, kidney function and histamine before peracetic acid exposure, after 1 - 2 days of the exposure and one week after exposure. A questionnaire a bout the subjective adverse effects was required to be filled in after exposures. All the volunteers felt, to different extent, uncomfortable after exposed the disinfected air, the white blood cells and monocytes increased (P < 0.05), that demonstrated a p otential inflammation. One week after the exposure, all the changed indexes recovered to the levels before exposure except the monocytes. If the indoor disinfection with peracetic acid is conducted according to that established guideline, some uncomfortabl e symptoms and decrease of monocytes and WBC will occurs, one week after exposed, however, all the changed indexes will recover except the monocytes, that means such impairments are reversible . d=07086962EN&q=peracetic+exposure&uid=788901738&setcookie=yes Evaluation of occupational exposure to high - level disinfectants in endoscopic services in an Italian hospital . Pacenti M, Dugheri S, Boccalon P, Arcangeli G, Cupelli V.; Int J Immunopathol Pharmaco l. 2006 Oct - Dec;19(4 Suppl):73 - 7. The aim of this study is the evaluation of exposure to airborne, high - level disinfectants to efficiently organize prevention of the risks due to the manipulation of these substances in the endoscopic units in medical facilities. In field and personal samples in the breathing zone of the workers were taken in 27 endoscopic units in a hospital during the replacement of high - level disinfectants in basins, tubes and lavaendoscopes. After a campaign of environmental monitoring of glutaraldehyde in nineteen endoscopic units (176 employees) of the hosp ital and considering the entity of glutaraldehyde problem, two substitutes, peracetic acid and electrolyzed acid water, have recently been introduced. The level of glutaraldehyde was higher than the TLV - Ceiling in 13 out of 19 working units, while the valu e of peracetic acid resulted higher than TLV - TWA in 1 out of 15. EAW has recently been used in two units and the chlorine environmental concentrations resulted lower than the sensibility limit of the method (<75 microg/m3). The results obtained during this study of measurements allowed to identify those operations which have the highest degree of risk for employees; this serves for taking suitable measures for prevention and individual protection as well as for evaluating current practices and decisional pr ocesses in the hospital. Peracetic Acid Exposure Assessment During Outbreak of SARS in Tianjin , China

14. ® Page 14 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Epidemiology ; You, Y; Bai, Z; Yan, L; Gao, X; Nov ember 2006 - Volume 17 - Issue 6 - pp S217 - S218; ISEE/ISEA 2006 Conference Abstracts Supplement: Session Abstracts. The Severe Acute Respiratory Syndrome (SARS) partly broke out in Southern China in December 2002 and spread rapidly almost over the country until June 2003. Peracetic acid, an excellent chemical disinfector, was recommended for the public disinfection by the Ministry of Health of China. Peracetic acid is a strong skin, eye, and mucous membrane irritant for both humans and animals, and continu ed skin exposure may cause liver, kidney, and heart problems. Direct skin contact and exposure to vapors would cause some health problems. A questionnaire survey was carried out among 65 nurses and 182 nonprofessionals related to medicine to collect the in formation concerning the working and living environment, health conditions, frequency and concentration of peracetic acid spraying, time - activity patterns, and adverse health effects. Results indicated that most of the 247 participants suffered from the di scomfort of skin, eyes, and respiratory tracts, and cough was the most common symptom (43.9% for nonprofessionals and 68.1% for nurses); 72.3% of the nurses suffered from skin burn, lacrimation, and/or eye pain as well as cough after the exposure of 8 hour s per day in the hospital where 0.5% peracetic acid was sprayed 3 to 5 times a day; 53.8% of common people, who exposed to peracetic acid vapor for 8 to 12 hours per day in the indoor environment where 0.2% to 0.5% peracetic acid was sprayed 2 or 3 times a day, suffered from skin itch, eye discomfort, and breathing difficulty. Serious symptoms appeared as skin diseases, injury of eyes, etc. A total of 132 participants who didn't have past history of respiratory illnesses appeared one or more symptoms when t hey were in the working environment disinfected by 0.2% to 0.5% peracetic acid within 10 to 30 minutes. Thirty - one participants' symptoms were more serious due to their chronic pharyngitis or respiratory diseases. Concentration variation of peracetic acid sprayed indoors was obtained from the simulating measurement conducted in a 20 - m3 room. Combining the simulated concentrations with daily activity pattern, potential dose of nurses working in the indoor environment where peracetic acid was sprayed 5 times a day was estimated as 20.6 mg/day. Although people will not suffer acute inhalation toxicity when they are exposed in the low concentration peracetic acid vapor according to our investigation and relevant reports, and discomfortable symptoms always disapp eared 3 to 5 hours after people left the sprayed area. Proper use methods should be followed when peracetic acid is widely used in the future to prevent possible injury. Assessment_During_Outbreak.555.aspx Evaluation of Worker Exposures to Peracet ic Acid - Based Sterilant during E ndoscope Reprocessing; D. Sylv ain, J. Gibbins The Health Hazard Evaluation (HHE) Program evaluated hospital employees' exposure to an enzymatic cleaner and a sterilant used to clean and sterilize endoscopes. Investigators found that air samples did not contain detectable concentrations of acetic acid; concentrations of peracetic acid were thought to be low but could not be measured. Investigators recommended increased ventilation in the sterilization room and use of appropriate PPE to prevent eye, face, hand, arm, and body contact with concentrated peracetic acid and contaminated equipment. - 0298 - 3090.pdf Considering risks to healthcare workers from glutaraldehyde alternatives in high - level disinfection . Rideout K, Teschke K, Dimich - Ward H, Kennedy SM., J Hosp Infect . 2005 Jan; 59(1):4 - 11. Due to concerns over glutaraldehyde's toxicity, two substitutes have recently been introduced; ortho - phthalaldehyde (OPA), and a mixture of hydrogen peroxide and peracetic acid. There is limited information about the health effects for employees from these products. This study assesses the current practices regarding the use of high - level disinfecta nts in British Columbian hospitals and predicts the relative toxicities of each product. Industry practices were compiled

11. ® Page 11 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 ng.pdf Sporicidal Effect of Peracetic Acid Vapor, Dorothy M. Portner And Robert K. Hoffman; Applied Micromology , Nov. 1968, 16 (11), p. 1782 - 1785 Kraft Pulp Bleaching with Hydrogen Peroxide and Peracetic Acid* F. POTÙÈEK** and M. MILICHOVSKÝ; Chem. Papers 54(6a), 406 - 411 (2000) , Scorecard - Chemical Profile for PERACETIC ACID (CAS Number: 79 - 21 - 0) This is a high volume chemical with production exceeding 1 mi llion pounds annually in the U.S. - profiles/summary.tcl?edf_substance_id=79 - 21 - 0#hazards Primary Literature Related to the Health Effects of Peracetic Acid Air monitoring and assessment of occupational exposure to peracetic a cid in a hospital environment . Pacenti M1, Dugheri S, Boccalon P, Arcangeli G, Dolara P, Cupelli V; Ind Health . 2010;48(2):217 - 21. A new automated method based upon solid phase micro - extraction (SPME)/fast gas chromatography - mass spectrometry (GC - MS) was developed for the quantitative determination of airborne peracetic acid (PAA). The method is suitable for the quick assessment of brief acute exposure as well as for long - term environmental monitoring of PAA and can assist in improving safety and environmental quality in workplaces where disinfectan ts are used. During a monitoring campaign in the Regional Hospital of Florence, Italy, the 8 - h average air concentration of PAA was 1/10 of the threshold limit value of time weighted average in 87% of the clinical units tested. However, the application of the new SPME method showed that short - term exposure to PAA could be relatively elevated in some hospital units with poor ventilation, allowing prompt intervention in order to reduce worker exposure to this potentially toxic compound. Full text available fr om Irritant vocal cord dysfunction and occupational bronchial asthma: differential diagnosis in a health care worker ; Stefano Tonini, Antonio Dellabianca, Cristina Costa, Andrea Lanfranco, Fabrizio Scafa, Stefan o Candura; International Journal of Occupational Medicine and Environmental Health . Volume 22, Issue 4, Pages 401 – 406 Objectives: Vocal cord dysfunction (VCD) is an uncommon respiratory disease characterized by the paradoxical adduction of voc al cords during inspiration, that may mimic bronchial asthma. The pathogenesis of VCD has not been clearly defined but it is possible to recognize non - psychologic and psychologic causes. The majority of patients are female but, interestingly, a high incide nce of VCD has been documented in health care workers. A misdiagnosis with asthma leads to hospitalisation, unnecessary use of systemic steroids with related adverse effects, and sometimes

10. ® Page 10 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 high PAA/H 2 O 2 ratio and others with a low PAA/H 2 O 2 ratio and so whether a reading on the Draeger tube is significant or not would depend on the blend of PAA being used. 4) PAA absorbs much more readily on many porous surfaces than hydrogen peroxide including on glass, silica, alumina and many ceramics. The gas path into the Draeger tube for hydrogen peroxide comprises the glass tube, then a beige disk with small holes in it (looks like an un glazed ceramic), and then the white crystalline silica that is treated with KI. Without testing that these materials do not absorb PAA, it would be reckless to assume that all the PAA drawn into the tube ends up making a color stain with the same cali bration function as hydrogen peroxide. Another more complex argument has been made that since PAA is formed as an equilibrium mixture with hydrogen peroxide and acetic acid (see above) then if one knew the vapor concentration of acetic acid and hydrogen peroxide, one could calculate the concent ration of PAA. The argument assume s that the vapor concentration is proportional to the mole fraction of the solution and the vapor pressure of that component and so vapor concentration of the three compone nts is a fixed ratio, albeit different from the solution ratio. The problem with this approach is that in most plants, with air exchanges etc. the system is not at steady state, the vapor concentrations are not at the equilibrium vapor concentrations and s o these calculations, though elegant, often do not work in practice. Assorted Publications on the U ses of Peracetic Acid Hydrogen Peroxide, Peroxyacetic Acid, Octanoic Acid, Perox yoctanoic Acid, And 1 - Hydroxyethylidene - 1,1 - Diphosphonic Acid (Hedp) As Components Of Antimicrobial Washing Solution, Chemical And Technical Assessment (CTA) Prepared by Ma. Patricia V. Azanza; © FAO 2004 PAA use in the Food industry 236k).pdf Suitability of Peracetic Acid for Sterilization of Media for Mycoplasma Cultures; P. WUTZLER,* M. SPROSSIG, AND H. PETERSEIM , JOURNAL OF CLINICAI MICROBIOLOGY. Mar. 1975, 1 (3), 246 - 249 . Peracetic Acid In The Disinfection Of A Hospital Water System Contaminated With Legionella Species; Savina Ditommaso; Cinzia Biasin; Monica Giacomuzzi; Car la Maria Zotti; Alberto Cavanna; Angela Ruggenini Moiraghi ; Infection Control And Hospital Epidemiology May 2005 , p 490. e/PERACETIC_ACID_IN_THE_DISIN FECTION.pdf Use of peracetic acid to sterilise human donor skin for production of tissue engineered skin matrices for clinical use, September 2003 Q.Huang, R. Dawson, D. Pegg, J. Kearney, S. Mac Neil; European Cells and Materi als Vol. 6. Suppl. 2, 2003 , p4.

22. ® Page 22 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Respiration: Other changes Blood: Pigmented or nucleated red blood cells inhalation mouse lowest published toxic concentration: 186 mg/m 3 /1 hour/90 day - intermittent Liver: Fatty liver degeneration Lung, Thorax, or Respiration: Other changes WZHMAE 33,513,1984 inhalation rat lowest published toxic concentration: 350 mg/m 3 /30 day - intermittent Lung, Thorax, or Respiration: Other changes Liver: Other changes Kidney, Ureter, and Bladder: Other changes GISAAA 48(6),28,1983 REVIEWS: ORGANIZATION STANDARD REFERENCE N/R N/R N/R STANDARDS AND REGULATIONS: ORGANIZATION STANDARD REFERENCE Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 1988 PESTICIDE SUBJECT TO REGISTRATION OR RE - REGISTRATION FEREAC 54,7740,1989 Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 1998 STATUS OF PESTICIDES: RED Completed RBREV* - ,331,1998 NIOSH DOCUMENTATION AND SURVEILLANCE: ORGANIZATION STANDARD or SURVEY REFERENCE National Occupational Hazard Survey 1974 National Occupational Hazard Survey 1974: Hazard Code: 84020; Number of Industries 1; Total Number of Facilities 33; Number of Occupations 2; Total Number of Employees Exposed 1,683

6. ® Page 6 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 • Sept 2008: T hirty workers at a seafood processing plant in Abrams Village, Prince Ed ward Island, were taken to hospital after being exposed to high levels of PAA . - release - clears - processing - plant/10002 28388/?& • May 2006: Cape Cod Ambulatory Surger y Laser Center evacuated after release of PAA fumes from punctured box. http://www.capecodonlin 01/305179991&template=printart • March 2006: mishandling of PAA at Boston Medical Center forced the evacuation of about 150 people from two of the center's buildings, plus more people from a nearby homeless shel ter. • Oct 2004: 85 employees evacuated after 40 gallon PAA spill at Bellvue, WA Coca Cola bottling pl ant • Oct 2003: St Vincent's Hospital , Melbourne, Australia, PAA leak at hospital results in evacuation of department and operating rooms . 10/07/1065292575186.html PAA Exposure from FDA MAUDE Database (2013 only ) • Med ivators Medivators Rapicide Pa Peracetic Acid Disinfectant Event Description: (b)(6) report received (b)(4) 2013 stating: inhalation exposure for an extended period of time. Operator loss consciousness and symptoms included headache, nausea, nose bleed, vomiting and tightness in chest. [Manufacturer could get no f urther details, but there must be more to this report than what is stated above] 6 • Steris Corporation - Hopkins Steris System 1E Liquid Chemical Sterilant Processing System , Event Description: When a user facility employee initiated a processing cycle on a system 1 e, the cycle aborted for a fill problem; this occurred 3 times. Each time the employee removed the full s40 cup and disposed of the contents by moving the cup to an empty sink, cutting it open and manually rinsing out the contents. There was a c omplaint of a strong odor. The employee visited employee health, was given a breathing treatment and sent home for the remainder of the day. The employee returned to work on the next scheduled shift and is fine. No procedural delays or cancellations report ed. [Manufacturer found user error] 7 • System 1E: AER leaked solution for 23 minutes. Employee wet with burning skin, OK after washing and changing. Technician could not repeat. 6 7

16. ® Page 16 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 high - level disinfection in hospitals for 40 years. Two substitutes have recently been introduced — ortho - phthalaldehyde and a mixture of hydrogen p eroxide and peracetic acid — despite limited health effects information about the products. This project used a two - tiered approach to evaluate the risks associated with substitution of high - level disinfectants. It involved predicting the relative toxic effe cts of all the products and assessing the current practices regarding the use of high - level disinfectants in British Columbia hospitals. Relative potential toxicities were examined based on regulatory data, a review of the published literature, and a quali tative structure – activity relationship analysis. .... Although little epidemiological data was available for hydrogen peroxide or peracetic acid, structure – activity analysis results suggest little risk of sensitization. Current practices in industry were ass essed using a comprehensive survey of current practices and decision processes in all hospitals in British Columbia. Of 95 hospitals, 64 returned surveys; 80% of these used high - level disinfection. Among user hospitals, 49% used glutaraldehyde only and 51% had introduced alternatives. Concern about employee health was the most common reason for substituting but was frequently not considered when choosing specific alternatives. Although occupational health and safety staff were available to 67% of user hospi tals, they were involved in the decision process about the use of chemical high - level disinfectants in only 41%. Hospitals that involved occupational health, infection control, or regional staff in high - level disinfectant decisions used glutaraldehyde alte rnatives less frequently. In most hospitals it was difficult to find any one person knowledgeable about the use of disinfectants at the site. Despite the fact that little is known about the risks to employees from glutaraldehyde alternatives, their use is widespread. The potential risks of all high - level disinfectants are serious; thus, regulators are faced with important risk management decisions not only before introducing new chemicals, but also after they have been introduced into the workplace. Sensory irritation of acetic acid, hydrogen peroxide, peroxyacetic acid and their mixture in mice . Gagnaire F, Marignac B, Hecht G et al. Ann Occup Hyg ; 46: 97 – 102 , (2002) The expiratory bradypnoea indicative of upper airway irritation in mice was evaluated during a period of 60 min of oronasal exposure to acetic acid, hydrogen peroxide and peroxyacet ic acid vapours. The airborne concentration resulting in a 50% decrease in the respiratory rate of mice (RD50) was calculated for each chemical. The concentration – response curves of acetic acid, hydrogen peroxide and peroxyacetic acid had similar slopes. T he results did however show that the three chemicals had different irritant potencies. The RD50 values of acetic acid, hydrogen peroxide and peroxyacetic acid were 227, 113 and 5.4 p.p.m. respectively. Moreover, a mixture containing 53% acetic acid, 11% hy drogen peroxide and 36% peroxyacetic acid had an RD50 of 10.6 ppm, 3.8 ppm being peroxyacetic acid, which is 1.4 times lower than the theoretical value estimated from the fractional concentrations and the respective RD50s of the individual components. On t he basis of a TLV - STEL (threshold limit value for short - term exposure limit) equal to 0.1 RD50, the TLV - STELs for acetic acid, hydrogen peroxide and peroxyacetic acid should not exceed 20, 10 and 0.5 p.p.m. respectively. On the basis of a TLV - TWA (time - wei ghted average) equal to 0.03 RD50, the TLV - TWAs for these same chemicals should not exceed 5, 3 and 0.2 p.p.m. respectively. Finally, these values and existing TLVs in Europe and the USA are compared. Generation of Controlled Atmospheres for the Determination of the Irritant Potency of Peroxyacetic Acid ; G. HECHT and M . HÉRY; Ann Occup Hyg (2002) 46 (1): 89 - 96. Given the physic al properties of peroxyacetic acid, which decomposes into acetic acid and hydrogen peroxide, the generation and analysis of controlled atmospheres used to test the irritant potency of this peracid in mice require specific developments. The sampling and ana lytical method was based on the simultaneous sampling on a titanyl sulphate - impregnated silica gel tube (allowing the determination of total peroxides, peroxyacetic acid and hydrogen peroxide) and in an

9. ® Page 9 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Analytical Method: Peracetic Acid and Hydrogen Peroxide Assay for 5% Peracetic Acid. Hydrogen peroxide is titrated with ceric sulfate. The peracetic acid is the n determined iodometrically. LaMotte Company, Box 329, Chestertown, MD 21620. s/PAA%20 Analytical%20Method.pdf Inability to D e tect PAA by Detecting Hydrogen Peroxide and Acetic Acid Some industrial hygienists have tried to determine if peracetic acid vapor concentrations were hazardous by using gas detector tubes for hydrogen peroxide and acetic acid. Based on the construction of the tubes, the acetic acid tube is unlikely to give any response to peracetic acid vapor and the hydrogen per oxide tube may be prone to loss of PAA through absorption and so the response is uncalibrated. Even if there is a response to PAA it is impossible to distinguish it from hydrogen peroxide even though the former is a stronger oxidant and so more hazardous. Therefore using acetic acid and hydrogen peroxide detector tubes to determine the PAA concentration is not a valid method. Some industrial hygienists, on being called into a facility that uses PAA in response to employee complaints of stinging eyes, sore throats, respiratory problems and loss of voice, lacking a method for PAA, would measure the concentration of acetic acid and hydrogen peroxide with detector tubes and declare that if these two species were within there limits then the PAA concentration mu st also be within safe limits too. This argument is of course fallacious for several reasons. 1) Using Draeger tubes as an example, the detector tube for acetic acid is intended to measure acetic acid over the range 5 to 80 ppm. If we want ed to detect PAA around 0.4 ppm ( the ACGIH TLV STEL value ), it would not even show up on the scale. 2) Additionally, t his detector tube contains a pH indicator which turns color with acetic acid. 21 However, acetic acid is a much stronger acid than PAA as indicated by the lower pK a value. The pK a for acetic acid is 4.76 and for 8.20 for peracetic acid. 22 Since the pK a s are so far apart, it is unlikely that the indicator used for acetic acid would re spond to PAA. Therefore the acetic acid tube does not even respond to PAA. 3) The Draeger tube for hydrogen peroxide 23 is for 0.1 to 3 ppm hydrogen peroxide. This tube is based on a color change with potassium iodide, which will response to almost any ox idizing agent, and so would probably give a response with PAA. If we wanted to measure 0.2 ppm PAA, it would be on the scale of this tube. However, as discussed above, the PAA is used in an equilibrium mixture with acetic acid and hydrogen peroxide and so there will always be some hydrogen peroxide present. If the tube gave a reading of 0.8 ppm, there is no way of determining if this is safe (no PAA, 0.8 ppm H 2 O 2 which is below the OSHA PEL for H 2 O 2 of 1 ppm), or if this hazardous (0.8 ppm PAA, no H 2 O 2 , twi ce the ACGIH TLV STEL for PAA). There are many blends of PAA, some with a 21 Draeger tube 6722101, 5 – 80 ppm, Draeger Tube handbook, Published by National Draeger Inc. (now Draeger Safety) 1992 22 Lange’s Handbook of Chemistry, 12 th Ed. 23 Draeger tube 8101041

23. ® Page 23 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 National Occupational Exposure Survey 1983 National Occupa tional Exposure Survey 1983: Hazard Code: 84020 ; Number of Industries 2; Total Number of Facilities 31; Number of Occupations 4; Total Number of Employees Exposed 1,728; Total Number of Female Employees Exposed 91 STATUS IN FEDERAL AGENCIES: ORGANIZATION REFERENCE EPA TSCA Section 8(b) CHEMICAL INVENTORY Used as polymerization initiator, curing agent and cross - linking agent EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JANUARY 2001 REFERENCES: CODEN REFERENCE BSPII* SPI Bulletin. (Soc. of the Plastics Industry, 250 Park Ave., New York, NY 10017) FEREAC Federal Register. (U.S. Government Printing Office, Supt. of Documents, Washington, DC 20402) V.1 - 1936 - GISAAA Gigiena i Sanitariya. For English translation, see HYSAAV. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1 - 1936 - JNCIAM Journal of the National Cancer Institute. (Washington, DC) V.1 - 60, 1940 - 78. For publisher information, see JJIND8. MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1 - 1964 - MUTAEX Mutagenesis. (Oxford Univ. Press, Pinkhill House, Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.1 - 1986 - RBREV* Status of Pesticides in Registration, Reregistration, and Special Review (Rainbow Report), Special Review and Reregistration Division Office of Pesticide Programs U.S. Environmental Protection Agency, 401 M. Street, S.W., Washington, D.C. 20460, Spring 1998 UCDS** Union Carbide Data Sheet. (Union Carbide Corp., 39 Old Ridgebury Rd., Danbury, CT 06817) WZHMAE Wissenschaftliche Zeitschrift der Humboldt - Universitaet zu Berlin, Mathematisch - Naturwissenschaftliche Reihe. (DDR - 1004 Berlin, Strasse der Pariser Kommune 3/4, zu richten) V.1 - 36, 1951/52 - 87. YHTPAD Yaoxue Tongbao. Bulletin of Pharmacology. (China International Book Trading Corp., POB 2820, Beijing, Peop. Rep. China) V.13 - 23, 1978 - 88. For publisher information, see ZYZAEU. Used as polymerization initiator, curing agent and cross - linking agent

12. ® Page 12 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 tracheostomy and intubation. In a subset of VCD patients, the disea se can be attributed to occupational or environmental exposure to inhaled irritants. Materials and Methods: We report the case of a 45 - year - old woman, working as a nurse, who complained of wheezing, cough, dyspnoea related to inhalation of irritating agent s (isopropylic alcohol, formaldehyde, peracetic acid). She underwent chest radiography, pulmonary function assessment both in the presence and in the absence of symptoms, bronchial provocation with methacholine and bronchodilation test with salbutamol to r ecognize asthma's features, allergy evaluation by skin prick tests and patch tests and video - laryngoscopy. Results: VCD diagnosis was made on the basis of video - laryngoscopy, that visualized the paradoxical motion of the vocal cords during symptoms, in the absence of other pathologic processes. Conclusions: This case fulfils the proposed criteria for the diagnosis of irritant VCD (IVCD). This is the first report of VCD onset following exposure to several irritants: formaldehyde, glutaraldehyde, isopropylic alcohol, peracetic acid - hydrogen peroxide mixture. These substances are used as cleaning and antiseptic agents in healthcare settings and some ones can also be found in many indoor environments. A correct diagnosis is important both to give the appropriate treatment and for medical legal implications. - 4/v10001 - 009 - 0038 - z/v10001 - 009 - 0038 - z.xml Case Study: Asthma Caused by Peracetic Acid - Hydrogen Peroxide Mixture ; Emmanuelle Cristofari - Marquand, Myriam Kacel , Francois Milhe3, Antoine Magnan And Marie - Pascale Lehucher - Michel . J Occup. Health ( 2007 ) 49 (2), 155 - 158 . Asthma Caused by Peracetic Acid - Hydrogen Peroxide Mixture Thorough preventive measures against potential patient infections caused by endoscopic ma terial has become a priority in hospitals and has pushed hospital care personnel to use increasingly more powerful disinfectant products with much longer contact periods, which has been responsible for a deterioration in their health. Among chemical disinf ectants, formaldehyde and glutaraldehyde were the most widely used for reducing microbial contamination responsible for infectious accidents following invasive endoscopies. At present, oxidizing agents such as PA - HP, have replaced them but are known to be ineffective for the prion inactivation cycle and to have toxic effects on patients, nursing staff and the environment. PA - HP is officially recommended with respective concentrations of 0.08% and 1% for best sterilization of germs responsible for infections and on biofilm (organic polymer sticking to a surface). Occupational asthma has been documented in nurses exposed to solvents such as formaldehyde but has not yet been described in workers exposed to PA - HP. We report the cases of two subjects who develope d cough, wheezing and shortness of breath after being exposed to PA - HP vapors. - ; Occupational exposure evaluation in some endoscopic services of Campania region sanitary structures . d'Angelo R, Russo E, Attaianese L, Niutta F., Contarp, INAIL, Dire zione Regionale per la Campania; G Ital Med Lav Ergon. 2007 Jul - Sep;29(3 Suppl):747 - 8. Article in Italian] Peroxyacetic acid is an organic peroxide characterized by an elevated oxidative power, a remarkable biocide effectiveness (higher than the glutaraldehyde) and it can result cold germicidal at concentrations down to the 0.2%, too. In these last years, its use has been introduced in the sanitary sector in glutaraldehyde substitution (GTA), for the endoscopic material disinfection. The goal of this study has been to determine t he aerodisperse peroxyacetic acid (APA) concentrations released by APA daily employment in endoscopic surgery operating rooms and sanitary endoscopy sections, related to some Campania region structures. A thirty samplings collection has been performed in " fixed posting", 15 measures in proximity of the "basins" and other 15 samplings in the closeness of the "automatic endoscope washer - disinfectors", to appraise the environmental pollution level during the whole working turn. Besides, 18 personal dosimetries

2. ® Page 2 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Basic Information on Peracetic Acid Names: Peracetic acid; Peroxyacetic acid ; Ethaneperoxoic acid ; Acetyl hydroperoxide Formula: C 2 H 4 O 3 / CH 3 COOOH Molecular mass: 76.1 g/mol ICSC # 1031 ; CAS # 79 - 21 - 0 ; RTECS # SD8750000 ; UN # 3105 ; EC # 607 - 094 - 00 - 8 Peracetic acid (AcOOH) is formed as an equilibrium mixture with acetic acid (AcOH) and h ydrogen peroxide (H 2 O 2 ). AcOH + H 2 O 2  AcOOH + H 2 O PAA is a weak acid, pK a = 8.20 at 25 o C 1 The odor threshold for PAA is 50 ppm (Solvay) 2 Summary Health Effects of PAA Exposure NJ Dept o f Health and Senior Services, Hazardous Substance Fact Sheet 3 HAZARD SUMMARY * Peroxyacetic Acid can affect you when breathed in. * Peroxyacetic Acid is a HIGHLY CORROSIVE CHEMICAL and contact can severely irritate and burn the skin and eyes leading to eye damage. * Breathing Peroxyacetic Acid can irritate the nose and throat. * Breathing Peroxyacetic Acid can irritate the lungs ca using coughing and/or shortness of breath. Higher exposures can cause a build - up of fluid in the lungs (pulmonary edema), a medical emergency, with severe shortness of breath. * High or repeated exposure may affect the liver and kidneys. * Peroxyacetic A cid is a HIGHLY REACTIVE CHEMICAL and a DANGEROUS EXPLOSION HAZARD. ... HEALTH HAZARD INFORMATION Acute Health Effects The following acute (short - term) health effects may occur immediately or shortly after exposure to Peroxyacetic Acid: * Contact can s everely irritate and burn the skin and eyes leading to eye damage. * Breathing Peroxyacetic Acid can irritate the nose and throat. 1 Lange’s Handbook of Chemistry, 12 th Ed. 2 - Solutions.pdf , retrieved 5/23/14 3 , retrieved 5/13/2014

7. ® Page 7 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 • Mild chemical burns on arms and face from removing the S40 sterilant. 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 • The user facility reported that an employee opened the lid to a system 1e, afte r noticing s40 powder in the bottom of the cup well, and experienced a burning sensation in her eyes. The s40 cup was disposed of. The employee self - administered otc eye drops and referred to the msds for the product for treatment instructions. The employe e has no sustaining injuries. No procedural delays or cancellations occurred. 17 • The user facility reported a strong odor coming from their system 1e unit during the first drain of the chamber. The odor irritated her nose and eyes so she left the room until the processing cycle completed. No injuries to hospital staff or patients were reported. No procedural delays or cancellations occurred. Manufacturer Narrative: A Steris service technician arrived on - site to inspect the unit and found that the new dr ain line, with 90 degree fittings on both ends, that was installed during the last service activity was creating an increase in resistance for the water flow during the draining processes. The increased resistance caused the water to flow more forcefully, allowing vapor to form during the draining process, resulting in a strong odor. The technician removed the 90 degree hose fittings from the drain line and re - secured it to the drain. The technician ran several test cycles, confirmed the unit operational an d returned it to service. • System 1E: The user facility reported that an employee was affected by sterilant fumes after he opened the lid of a system 1e unit. The employee was not wearing protective eyewear at the time of the event. The employee had noticed an error message on the system 1e that read ‘heat problem, cycle not complete.’ The employee then removed the partially emptied sterilant cup from the aspirator and was affected by sterilant fumes in the eyes and nasal passage . The employee then disposed of the s40 steriliant cup in a garbage bag. The employee washed his eyes using the eye wash station and visited an optometrist where he was prescribed eye drops for the irritation. The employee has since returned to work. The instrument in the system 1e at the time of the event was not used on patients and was reprocessed in another machine. 18 • System 1E: The user facility reported that an employee initiated a processing cycle, saw fluid starting to spill out from under the lid and detected an odor . The faci lity biomed was present in the room and stated he was starting to get a headache . A nurse who was also present in the room stated she started to feel sick . The nurse was advised to leave the room and sit down for a while. The nurse felt fine after leaving the room. No medical treatment was sought or administered. No injuries or procedural delays/cancellations were reported. 19 • System 1E: The user facility reported that after initiating a processing cycle it had faulted. An employee removed the s40 cup and li quid contacted her. The employee stated she experienced irritation to her nose and throat and went outside for fresh air and did not miss time from work. No further medical treatment was sought or administered. 20 8 http :// 9 10 11 http://www.accessdat 12 946267 13 14 15 http://w 16 mdrfoi__id=3140185 17 18 19 20 http://www.accessdat

4. ® Page 4 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 • 103 ppm causes severe cough, lacrimation, salivation, decreased coordination and alertness, labored breathing and death in rats. • 5.4 ppm caused a 50% respiratory depression rate in mice • 2 ppm resulted in extreme discomfort to mucosal membranes • 0.5 to 1 ppm produced mild discomfort • 0.5 to 0.6 ppm for up to 3 hours was not immediately irritating but was considered to be unpleasant if the exposure was over an extended time. • < 0.5 ppm no discomfort • 0.13 to 0.17 ppm the PAA was detectable but was not unpleasant E PA Acute Exposure Guideline Levels (AEGLs) Peracetic Acid 79 - 21 - 0 (Inte rim) mg/m 3 12/13/04 10 min 30 min 60 min 4 hr 8 hr AEGL 1 0.52 mg/m 3 0.52 mg/m 3 0.52 mg/m 3 0.52 mg/m 3 0.52 mg/m 3 AEGL 2 1.6 mg/m 3 1.6 mg/m 3 1.6 mg/m 3 1.6 mg/m 3 1.6 mg/m 3 AEGL 3 60 mg/m 3 30 mg/m 3 15 mg/m 3 6.3 mg/m 3 4.1 mg/m 3 N ote that values are in mg/m 3 NOT ppm. The ppm equivalents are shown below: EPA AEGL 1: 0.52 mg/m 3 (0.17 ppm) EPA AEGL 2: 1.6 mg/m 3 (0.51 ppm) EPA AEGL 3: 4.6 mg/m 3 (1.3 ppm) Solvay Solvay (manufactur er of PAA) recommended exposure limits for PAA = 0.15 ppm TWA, 0.46 mg/m3 TWA. - PAA - RESP.pdf TERA/Ecolab A study has been conducted by researches from TERA and Ecolab (a major manufacturer of PAA) on the appropriate exposure limits for PAA by comparing the literature. Their conclusions were: • We calculated potential TWA OELs ranging from 0.26 to 1.56 mg/m 3 [0.084 to 0.50 ppm] . • This is similar to the range of 0.62 – 2 mg/m 3 [0.20 to 0.64 ppm] found among the pub lished OELs. • Any value within the range could be justified as protective of worker health in light of the un certainties in the data and the precision of the OEL methodology. • More definitive sensory irritation studies would further clarify selection of a value in this range. • The ultimate OEL choice is a policy - based risk management decision, not a scientific on e.

20. ® Page 20 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 - _KOCHKLEENR_OX_SANITANT.pdf International Chemical Safety Cards PERACETIC ACID (stabilized) ICSC: 1031 TYPES OF HAZARD/ EXPOSURE ACUTE HAZARDS/ SYMPTOMS PREVENTION FIRST AID/ FIRE FIGHTING EXPOSURE AVOID ALL CONTACT! •INHALATION Burning sensation. Cough. Laboured breathing. Shortness of breath. Sore throat. Symptoms may be delayed (see Notes). Ventilation, local exhaust, or breathing protection. Fresh air, rest. Half - upright position. Refer for medical attention. See Notes. •SKIN MAY BE ABSORBED! Redness. Pain. Blisters. Skin burns. Protective gloves. P rotective clothing. First rinse with plenty of water, then remove contaminated clothes and rinse again. Refer for medical attention. •EYES Redness. Pain. Severe deep burns. Face shield, or eye protection in combination with breathing protection. Firs t rinse with plenty of water for several minutes (remove contact lenses if easily possible), then take to a doctor. •INGESTION Abdominal pain. Burning sensation. Shock or collapse. Do not eat, drink, or smoke during work. Rinse mouth. Do NOT induce vomiting. Refer for medical attention. RTECS Database – Peracetic Acid , RTECS #: SD8750000 (last updated May 2007) (Available from ) SKIN AND EYE IRRITATION DATA AND REFERENCES: ROUTE/ ORGANISM DOSE EFFECT REFERENCE Eye rabbit 1 mg severe UCDS** 12/12/1968 Skin rabbit 500 mg open irritation test severe UCDS** 12/12/1968 MUTATION DATA AND REFERENCES: SYSTEM TEST ROUTE/ ORGANISM/ TISSUE DOSE REFERENCE DNA damage human leukocyte 0.5 ppm/1 hour MUTAEX 19,157,2004 DNA damage multiple other fish 0.61 mg/L/20 day - continuous MUREAV 557,119,2 004

24. ® Page 24 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 NIOSH PROFILE (PERACETIC ACID), PRAB, 6/80 NIOSH PROFILE (PEROXIDES, ORGANIC), SRC, 12/79 RTECS Compound Description: Agricultural Chemical Tumorigen Mutagen Primary Irritant Peroxyacetic acid – IUPAC global availability of information on agrochemicals This site has been produced by a sub - group of the IUPAC Advisory Committee on Agrochemicals. 25 HUMAN HEALTH Property Value Source/Quality Score/Other Information Interpretation Mammals - Acute oral LD50 (mg kg - 1 ) 1540 Q3 Rat Moderate Mammals - Dermal LD50 (mg kg - 1 body weight) > 1410 Q3 Rabbit - Mammals - Inhalation LC50 (mg l - 1 ) - - - WHO Classification NL - Not listed US EPA Classification (formulation) III - Caution - Slightly toxic EC Risk Classification [T - Toxic: R23, R24, R25], [H - Handling risks: R5, R34] EC Safety Classification S3, S27, S36 ADI - Acceptable Daily Intake (mg kg - 1 bw day - 1 ) - - - ARfD - Acute Reference Dose (mg kg - 1 bw day - 1 ) - - - AOEL - Acceptable Operator Exposure Level - Systemic (mg kg - 1 bw day - 1 ) - - - Dermal penetration studies (%) - - - Dangerous Substances Directive 76/464 - - - Exposure Limits - - - 25 ht tp://

21. ® Page 21 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 mutation in microorganisms Saccharomyes cerevisiae 5 ppm/2 hour MUTAEX 19,157,2004 micronucleus test multiple other fish 0.2 ppm/72 hour - continuous MUREAV 587,103,2005 REPRODUCTIVE EFFECTS DATA AND REFERENCES: ROUTE/ ORGANISM DOSE EFFECT REFERENCE N/R N/R N/R N/R TUMORIGENIC DATA AND REFERENCES: ROUTE/ ORGANISM DOSE EFFECT REFERENCE Skin mouse lowest published toxic dose: 21 gm/kg/26 week - intermittent Tumorigenic: Equivocal tumorigenic agent by RTECS criteria Skin and Appendages: Tumors Tumorigenic: Tumors at site of application JNCIAM 55,1359,1975 ACUTE TOXICITY DATA AND REFERENCES: ROUTE/ ORGANISM DOSE EFFECT REFERENCE Inhalation rat lethal concentration (50 percent kill): 450 mg/m 3 N/R GISAAA 48(6),28,1983 Intravenous mouse lethal dose (50 percent kill): 17,860 μg/kg N/R YHTPAD 2 3,345,1988 Oral guinea pig lethal dose (50 percent kill): 10 mg/kg N/R BSPII* 1/75 - 19B Oral mouse lethal dose (50 percent kill): 210 mg/kg N/R GISAAA 48(6),28,1983 Oral rat lethal dose (50 percent kill): 1,540 μL/kg N/R UCDS** 12/12/1968 S kin rabbit lethal dose (50 percent kill): 1,410 μL/kg N/R UCDS** 12/12/1968 OTHER MULTIPLE DOSE DATA AND REFERENCES: ROUTE/ ORGANISM DOSE EFFECT REFERENCE inhalation guinea pig lowest published toxic concentration: 186 mg/m 3 /1 hour/90 day - intermittent Liver: Fatty liver degeneration Lung, Thorax, or WZHMAE 33,513,1984

5. ® Page 5 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 • The optimal time averaging approach is not clearly established by the data; however, a combination of a TWA with a STEL is recommended as a preferred risk management option. Per acetic Acid Exposure in the Headlines • April 2014 Chicken plant workers say chemicals including PAA sprayed on carcasses are making them sick . - plant - workers - say - chemicals - sprayed - carcas/nfg73/ • Nov. 2013 Harrogate Hospital, UK, PAA spill in endoscopy unit causes 100 outpatients to be evacuated, - england - york - north - yorkshire - 24864879 • Nov 2013. Hazmat Crews clean up PAA Spill at Cape Coral Hospital, Fl. - - crews - clean - up - hospital - chemical - spill#.Uozeu9LkuSp • July 2013: Pacific Coast Fruit Company, PAA spill at Pacific Coast Fruit Co. in Northea st Portland injured one person and led to the evacuation of about 150 employees . e ws_respond.html • June 2012: PAA spill causes evacuation of hospital floor , Northbay Regional Surgical Center. e - and - fire/p/hazmat - specialists - respond - to - medical - office • Feb. 2012, Llandudno Hospital, Wales , UK, PAA spill in hospital resulted in the early closure of the out - patients department . - wales - north - west - wales - 17215178 • Jan. 2012: 1 killed, 3 injured in PAA explosion in Shanghai Chemical plant. • 20 11: USDA Inspector Dies from Chronic Exposure to PAA & Chlorine in Poultry Plant - chicken - plants - chemicals - blamed - for - health - ailments - are - poised - to - proliferate/2013/04/25/d2a65ec8 - 97b1 - 11e2 - 97cd - 3d8c1afe4f0f_print.html • May 2010: 1 worker has suffered injury after acid fumes force partial evacuation at Ft. Worth Dannon plant . - Mishap - Forces - Partial - Evacuation - of - Fort - Wort.htm • April 2010 : P atients were evacuated after a PAA spill at Addenbrooke’s Hospital (UK). ua tion_1_211882 • June 2009: Two hospitalized after PAA spill in Sutter Gould Medical Foundation Specialty Center , Modesto , CA. - hospitalized - after - acid - spill.html

1. ® Page 1 of 25 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 phone 412.787.0202 • fax 412.788.2526 Paying Attention to Peracetic Acid Richard Warburton July 20 20 Introduction This report summarize s information on the safe use of peracetic acid in the workplace. Peracetic acid (PAA), alias peroxyacetic acid , is used as a disinfectant and sterilant in the food, water treatment and healthcare industries and as an oxidant in pulp and paper. There are currently no OSHA regulations specific to this compound, but there is there an ACGIH Threshold Limit Value ( TLV ) of 0.4 ppm , at a 15 minute short term exposure limit ( STEL ) . As a peroxo strong oxidizing agent, it is a primary irritant and studies indicate that it is potentially harmful to workers exposed to it in the workplace. Table of Contents Basic Information ................................ ................................ ................................ ................ 2 Summary Health Effects of PAA Exposure: NJ Fact Sheet ................................ ............... 2 Exposure Limits for Peracetic Acid ................................ ................................ .................... 3 ACGIH ................................ ................................ ................................ ............................ 3 EPA Acute Exposure Guideline Levels (AEGLs) ................................ .......................... 4 Solvay ................................ ................................ ................................ ............................. 4 TERA/Ecolab ................................ ................................ ................................ .................. 4 Peracetic Acid Exposure in the Headlines ................................ ................................ .......... 5 PAA Exposure from FDA MAUDE Database ................................ ................................ ... 6 Detection of Peracetic Acid ................................ ................................ ................................ 8 Continuous Monitor for peracetic acid ................................ ................................ ........... 8 Passive Sampling for Peracetic Acid Vapor ................................ ................................ ... 8 Laboratory Methods for Liquid Peracetic Acid. ................................ ............................. 8 Inability to Detect PAA by Detecting Hydrogen Peroxide and Acetic Acid .................. 9 Assorted Publications on the Uses of Peracetic Acid ................................ ....................... 10 Scorecard - Chemical Profile for PERACETIC ACID ................................ ................. 11 Primary Literature Related to the Health Effects of Peracetic Acid ................................ . 11 US Approval of PAA as a Sterilant ................................ ................................ .................. 19 Tabulated Safety Information ................................ ................................ ........................... 19 SDS for PAA ................................ ................................ ................................ ................. 19 International Chemical Safety Cards ................................ ................................ ............ 20 RTECS Database – Peracetic Acid ................................ ................................ ............... 20 Peroxyacetic acid – IUPAC global availability of information on agrochemicals ....... 24


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