[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