[Federal Register Volume 82, Number 43 (Tuesday, March 7, 2017)]
[Notices]
[Pages 12819-12821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04319]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number CDC-2017-0015, NIOSH-295]


Health Risks to Workers Associated With Occupational Exposures to 
Peracetic Acid; Request for Information

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Request for information.

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SUMMARY: The National Institute for Occupational Safety and Health of 
the Centers for Disease Control and Prevention intends to evaluate the 
scientific and technical data on occupational exposures to peracetic 
acid (CAS #79-21-0, also known as peroxyacetic acid and PAA). NIOSH is 
requesting information on the following: (1) Workplace exposure data 
for peracetic acid, (2) possible health effects observed in workers 
exposed to peracetic acid, (3) workplaces and products in which 
peracetic acid may be found, (4) description of work tasks and 
scenarios with a potential for exposure to peracetic acid, (5) reports 
and findings from in vitro and in vivo toxicity studies with peracetic 
acid, (6) data applicable to the quantitative risk assessment of health 
effects associated with acute, subchronic and chronic workplace 
exposures to peracetic acid, (7) sampling and analytical methods for 
peracetic acid, and (8) control measures, including engineering 
controls, work practices, and personal protective equipment (PPE), that 
are being used in workplaces where there is potential for exposure to 
peracetic acid.

DATES: Electronic or written comments must be received by June 5, 2017.

ADDRESSES: You may submit comments, identified by CDC-2017-0015 and 
docket number NIOSH-295, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: National Institute for Occupational Safety and 
Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, 
Ohio 45226-1998.
    Instructions: All information received in response to this notice 
must include the agency name and docket number [CDC-2017-0015; NIOSH-
295]. All relevant comments received will be posted without change to 
www.regulations.gov, including any personal information provided. For 
access to the docket to read background documents or comments received, 
go to www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: G. Scott Dotson, NIOSH, Education and 
Information Division, Robert A. Taft Laboratories, 1090 Tusculum 
Avenue, Cincinnati, OH 45226, (513) 533-8540 (not a toll free number).

SUPPLEMENTARY INFORMATION: Peracetic acid is a peroxide-based molecule 
used extensively as an antimicrobial agent in many commercial 
applications. It is routinely used as a sterilant during the cleaning 
of endoscopes and other medical devices, as a disinfectant in food 
processing, as a bleaching agent, and in the synthesis of other 
chemicals [NAS 2010; Pechacek et al. 2015]. The chemical and physical 
properties of peracetic acid make the molecule highly reactive, 
unstable, and volatile. Peracetic acid has a pungent, vinegar-like odor 
[NAS 2010].
    Peracetic acid is formed from a sulfuric acid-catalyzed chemical 
reaction between acetic acid and hydrogen peroxide [NAS 2010]. 
Peracetic acid solutions typically consist of a mixture of peracetic 
acid,

[[Page 12820]]

acetic acid, and hydrogen peroxide in various concentrations. NAS 
[2010] reported that technical or commercial peracetic acid products 
contain peracetic acid, acetic acid, and hydrogen peroxide in solution. 
Concentrations of peracetic acid in these products vary, but do not 
exceed 40%. Peracetic acid products containing more than 15% peracetic 
acid demonstrate excessive reactivity, instability, and some degree of 
explosiveness [Pechacek et al. 2015].
    Acute exposure to peracetic acid is irritating to the eyes, 
respiratory tract, and skin. Peracetic acid is a strong sensory 
irritant considered to be more potent than acetic acid or hydrogen 
peroxide [NAS 2010]. Cristofari-Margquand et al. [2007] indicated that 
healthcare workers experienced asthma associated with workplace 
exposures to peracetic acid. No data on human lethality due to exposure 
to peracetic acid were identified. Lethal exposures in animals caused 
hemorrhage, edema, and pulmonary consolidation [NAS 2010].
    NIOSH does not have a recommended exposure limit (REL) for 
peracetic acid. The Occupational Safety and Health Administration 
(OSHA) has not established a permissible exposure limit (PEL). The 
California Division of Occupational Safety and Health (CalOSHA) has not 
established a PEL for peracetic acid. The American Conference of 
Governmental Industrial Hygienists (ACGIH[supreg]) has established a 
threshold limit value (TLV[supreg])--short term exposure limit (STEL) 
of 1.24 mg/m\3\ (0.4 ppm) to protect workers against irritation of 
eyes, skin, and the upper respiratory tract [ACGIH[supreg] 2016]. The 
National Advisory Committee for Acute Exposure Guideline Levels for 
Hazardous Substances (NAC/AEGL Committee) has established AEGL values 
for peracetic acid [NAS 2010]. AEGL values are threshold exposure 
limits for the general public and are applicable to emergency exposure 
periods ranging from 10 minutes to 8 hours [NAS 2001]. AEGL-1 
represents an airborne concentration above which exposures could cause 
notable discomfort, irritation, or certain asymptomatic non-sensory 
effects. AEGL-2 represents an airborne concentration above which 
exposures could cause irreversible or other serious, long lasting 
adverse effects or an impaired ability to escape. AEGL-3 represents an 
airborne concentration above which exposures could cause life-
threatening effects or death. Table 1 summarizes the AEGL values for 
peracetic acid.

                                                        Table 1--AEGL Values for Peracetic Acid *
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                                             10 minute              30 minute              60 minute                4 hour                 8 hour
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AEGL-1...............................  0.52 mg/m \3\ (0.17    0.52 mg/m \3\ (0.17    0.52 mg/m \3\ (0.17    0.52 mg/m \3\ (0.17    0.52 mg/m \3\ (0.17
                                        ppm)                   ppm)                   ppm)                   ppm)                   ppm).
AEGL-2...............................  1.6 mg/m \3\ (0.5      1.6 mg/m \3\ (0.5      1.6 mg/m \3\ (0.5      1.6 mg/m \3\ (0.5      1.6 mg/m \3\ (0.5
                                        ppm)                   ppm)                   ppm)                   ppm)                   ppm).
AEGL-3...............................  60 mg/m \3\ (19 ppm)   30 mg/m \3\ (9.6 ppm)  15 mg/m \3\ (4.8 ppm)  6.3 mg/m \3\ (2 ppm)   4.1 mg/m \3\ (1.3
                                                                                                                                    ppm).
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* NAS [2010].

    In May 2015, NIOSH published a notice in the Federal Register [80 
FR 24930] announcing the availability of and a request for comments for 
the draft immediately dangerous to life or health (IDLH) values and 
support technical documents, entitled Immediately Dangerous to Life or 
Health (IDLH) Value Profiles, for 14 chemicals including peracetic 
acid. The proposed IDLH value for peracetic acid was 1.7 mg/m\3\ (0.55 
ppm) [draft NIOSH 2015]. The proposed recommendation was based on 
sensory irritation in human volunteers reported in Fraser and 
Thorbinson [1986]. Due to subsequent requests from the public, a 
supplemental notice was published in the Federal Register [81 FR 53147] 
announcing that NIOSH was seeking further comments on the draft IDLH 
Value Profile for peracetic acid. The public comments indicated that 
(1) the proposed IDLH value was overprotective, (2) the data available 
for peracetic acid are of low quality, and (3) issues exist with the 
sampling and analysis of air samples for peracetic acid in the 
workplace. Based on these comments, NIOSH is re-evaluating the proposed 
IDLH value for peracetic acid.
    Research efforts are needed to characterize the acute and chronic 
health effects of occupational exposures to peracetic acid. These 
efforts include: (1) Epidemiological and field studies designed to 
assess workplace exposures to peracetic acid, (2) in vivo and in vitro 
studies designed to characterize the acute, sub-chronic, and chronic 
effects of peracetic acid, (3) quantitative risk assessment(s) intended 
to characterize the increased risks associated with workplace exposures 
to peracetic acid, (4) evaluation of workplace controls, including 
engineering controls, administrative controls, and PPE, (5) development 
of analytical methods to accurately collect and analyze air samples of 
peracetic acid under various conditions (e.g., task-based monitoring, 
full-shift monitoring, real-time monitoring).
    Background: The purpose of the RFI is to seek information relevant 
to assessing the risk of occupational exposures to peracetic acid.
    Information Needs: Additional data and information are needed to 
assist NIOSH in characterizing and assessing the health risk of 
occupational exposures to peracetic acid. Information is needed on: (1) 
Workplace exposure data for peracetic acid, (2) possible health effects 
observed in workers exposed to peracetic acid, (3) workplaces and 
products in which peracetic acid may be found, (4) description of work 
tasks and scenarios with a potential for exposure to peracetic acid, 
(5) reports and findings from in vitro and in vivo toxicity studies 
with peracetic acid, (6) data applicable to the quantitative risk 
assessment of health effects associated with acute, subchronic and 
chronic workplace exposures to peracetic acid, (7) sampling and 
analytical methods for peracetic acid, and (8) control measures, 
including engineering controls, work practices, and personal protective 
equipment (PPE), that are being used in workplaces where there is 
potential for exposure to peracetic acid.

References

ACGIH[supreg] (American Conference of Governmental Industrial 
Hygienists) [2016]. Annual TLVs[supreg] (Threshold Limit 4 Values) 
and BEIs[supreg] (Biological Exposure Indices) booklet. Cincinnati, 
OH: ACGIH[supreg] Signature Publications.
Cristofari-Marquand E, Kacel M, Milhe F, Magnan A, Lehucher-Michel 
MP [2007]. Asthma caused by peracetic acid-hydrogen peroxide 
mixture. J Occup Health 49(2):155-158.
Fraser JAL, Thorbinson A [1986]. Fogging trials with Tenneco 
Organics Limited (30th June, 1986) at Collards Farm. Solvay Interox. 
Warington, United Kingdom.
NAS (National Academies of Science) [2001]. Standing operating 
procedures for developing acute exposure guidelines levels for 
hazardous chemicals. Washington, DC: National Academy Press. 
[https://www.epa.gov/sites/production/files/2015-09/documents/sop_final_standing_operating_procedures_2001.pdf].

[[Page 12821]]

NAS [2010]. Chapter 7: peracetic acid-acute exposure guideline 
levels. In: acute exposure guideline levels for selected airborne 
chemicals: volume 8. [http://www.epa.gov/opptintr/aegl/pubs/peracetic_acid_final_volume8_2010.pdf].
NIOSH (National Institute for Occupational Safety and Health) [draft 
2015]. Immediately dangerous to life or health (IDLH) value profile 
for peracetic acid. External review draft (Dated: March 2015). 
[https://www.cdc.gov/niosh/docket/review/docket156a/pdfs/g1-013-peracetic-acid-cas-79-21-0.pdf].
Pechacek N, Osorio M, Caudill J, Peterson B [2015]. Evaluation of 
the toxicity data for peracetic acid in deriving occupational 
exposure limits: A minireview. Toxicology Letters 233: 45-57.

    Dated: March 1, 2017.
Frank Hearl,
Chief of Staff, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2017-04319 Filed 3-6-17; 8:45 am]
 BILLING CODE 4163-18-P