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    Notice of Availability of the Regulatory Flexibility Act Review of the Occupational Health Standard for Ethylene Oxide
[Federal Register: April 22, 2005 (Volume 70, Number 77)][Rules and Regulations]               [Page 20807-20809]
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Rules and Regulations
                                                Federal Register

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Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. H-200C]
RIN 1218-AB60

Notice of Availability of the Regulatory Flexibility Act Review 
of the Occupational Health Standard for Ethylene Oxide

AGENCY: Occupational Safety and Health Administration, Department of 

ACTION: Notice of availability.


SUMMARY: The Occupational Safety and Health Administration (OSHA) has 
conducted a review of its Ethylene Oxide (EtO) Standard pursuant to 
section 610 of the Regulatory Flexibility Act and section 5 of 
Executive Order 12866 on Regulatory Planning and Review. EtO is used as 
a chemical intermediate to produce antifreeze and as a sterilant. In 
1984, OSHA promulgated a standard to lower exposure to EtO from 50 
parts per million (ppm) to 1 ppm based on evidence EtO exposure was 
associated with cancer in animals. The regulatory review has concluded 
that new studies indicate that EtO is associated with cancer in humans, 
that employee exposures have been substantially reduced thereby 
lowering risk to employees, that the standard has not had a negative 
impact on small businesses, that EtO production has increased, and that 
EtO sterilizers have been developed that meet the standard and cost 
less than older non-compliant sterilizers. Public commenters agree that 
the standard should remain in effect. Based on this review, OSHA 
concludes the EtO standard should remain in effect, but will issue new 
guidance materials in response to some commenters requests for 

ADDRESSES: Copies of the entire report may be obtained from the OSHA 
Publication Office, Room N3101, 200 Constitution Avenue, NW., 
Washington, DC 20210, telephone (202) 693-1888, Fax (202) 693-2498. The 
full report, comments, and referenced documents are available for 
review at the OSHA Docket Office, Docket No. H-200C Room N2625, 200 
Constitution Avenue, NW., Washington, DC 20210, telephone (202) 693-
2350. The main text of the report will become available on the OSHA Web 
page at http://www.OSHA.gov.

FOR FURTHER INFORMATION CONTACT: Joanna Dizikes Friedrich, Directorate 
of Evaluation and Analysis, Room N3641, OSHA, U.S. Department of Labor, 
200 Constitution Avenue, NW., Washington, DC 20210, telephone (202) 
693-1939, fax (202) Direct technical inquiries about the EtO standard 
to Gail Brinkerhoff, telephone (202) 693-2190, or visit the OSHA 
Homepage at http://www.OSHA.gov. Direct press inquiries to Bill Wright, Room 
N3647, telephone (202) 693-1999.

SUPPLEMENTARY INFORMATION: The Occupational Safety and Health 
Administration (OSHA) has completed a "look back" review of its EtO 
Standard, 29 CFR 1910.1047, titled "Regulatory Review of the 
Occupational Safety and Health Administration's Ethylene Oxide 
Standard, March 2005." This Federal Register document announces the 
availability of the Regulatory Review and briefly summarizes it. The 
review was undertaken pursuant to Section 610 of the Regulatory 
Flexibility Act (5 U.S.C. 601 et seq.) and Section 5 of Executive Order 
12866 (59 FR 51739, Oct 4, 1993) and all issues raised by those 
provisions. The purpose of a review under section 610 of the Regulatory 
Flexibility Act "Shall be to determine whether such rule should be 
continued without change, or should be rescinded, or amended consistent 
with the stated objectives of applicable statutes to minimize any 
significant impact of the rule on a substantial number of small 
    "The Agency shall consider the following factors:
    (1) The continued need for the rule;
    (2) The nature of complaints or comments received concerning the 
rule from the public;
    (3) The complexity of the rule;
    (4) The extent to which the rule overlaps, duplicates or conflicts 
with other Federal rules; and, to the extent feasible, with state and 
local governmental rules; and
    (5) The length of time since the rule has been evaluated or the 
degree to which technology, economic conditions, or other factors have 
changed in the areas affected by the rule."
    The review requirements of Section 5 of the Executive Order 12866 
require agencies:
    "To reduce the regulatory burden on the American people, their 
families, their communities, their state, local and tribal governments, 
their industries to determine whether regulations promulgated by the 
[Agency] have become unjustified or unnecessary as a result of changed 
circumstances; to confirm that regulations are both compatible with 
each other and not duplicative or inappropriately burdensome in the 
aggregate; to ensure that all regulations are consistent with the 
President's priorities and the principles set forth in the Executive 
Order, within applicable law; and to otherwise improve the 
effectiveness of existing regulations."
    OSHA published a Federal Register document requesting public 
comments on the EtO Standard and specifically all issues raised by 
those provisions, and held a public meeting on those matters (62 FR 
28649, May 27, 1997). The Review summarizes the public comments and 
responds to them.
    Ethylene Oxide is an industrial chemical that has high volume uses 
as an intermediate to produce other chemicals such as antifreeze. It is 
also used as a sterilant principally in the hospital, medical device 
and spice processing industries.
    In 1984, principally based on evidence of carcinogenicity in 
animals, OSHA issued a standard (29 CFR 1910. 1047) lowering exposures 
from 50 parts per million (ppm) to 1 ppm. That standard also included 
requirements for monitoring, medical surveillance, training and other 
    OSHA has reviewed the studies, information and public comments 
about the standard. Based on those, it has reached the following 
conclusions pursuant to the section 610 review discussed in greater 
length in the full report.
    There is a continued need for the rule. Workers exposed to EtO in a 
range of industries would continue to be at risk of cancer, genetic changes 
and other adverse health effects, without the standard. Since the standard 
was developed, the International Agency for Research on Cancer 
reclassified EtO as a known human carcinogen and the National 
Toxicology program reclassified EtO as a one "known to be a human 
carcinogen." Based on the significant scientific information, OSHA 
finds that the potential carcinogenicity of EtO and the risk posed to 
workers continues to justify the need for the Standard.
    Comprehensive studies, compliance information, and public comments 
indicate that the Standard has been effective in reducing exposure to 
EtO thereby achieving the predicted health benefits. The public 
comments evidenced widespread support for continuance of the EtO 
Standard and endorsed its effectiveness. No commenter argued that the 
standard should be rescinded.
    The evidence indicates that the EtO Standard has not had a negative 
economic impact on the industries affected by the standard, generally, 
or on small businesses in those industries. Production of EtO has 
increased from 6.2 billion pounds to 8 billion pounds since the 
standard was issued. Most of the small businesses affected by the EtO 
Standard are hospitals, medical device manufacturers, and spice 
manufacturers. There are no indications that the regulation of 
occupational exposure to EtO has impaired the economic well being of 
businesses in any of these sectors or has disproportionately affected 
small businesses.
    The rule is not unduly or unreasonably complex. Although most 
commenters did not directly address the issue of whether the standard 
was considered to be unduly or unreasonably complex, a few comments at 
the public meeting and comments submitted to the Docket requested 
clarification of a few requirements of the standard. OSHA intends to 
issue compliance assistance and outreach materials to aid employers' 
and employees' understanding of the standard.
    The EtO Standard does not overlap with other regulations. Four 
major federal regulatory entities in addition to OSHA currently 
regulate various aspects of EtO use and transport. The only potential 
regulatory conflict raised by one commenter during this lookback review 
involved an Environmental Protection Agency standard under the Clean 
Air Act for EtO using commercial sterilization and fumigation 
operations. Commercial sterilization and fumigation operations using 
one ton or more of EtO per year are required to use emission control 
technology to comply with EPA standards. The two agencies' rules do not 
actually conflict and no employers have stated that they have not been 
able to comply with both.
    Technological improvements have improved worker safety. OSHA's 
independent research, comments received, and the technical literature 
indicate that significant technological developments have occurred 
since the promulgation of the standard. Improvements in sterilizer 
technology, the growth in number and use of alternative sterilants and 
sterilizing processes, and use of contract sterilizers to perform EtO 
sterilization have contributed to an observed reduction in occupational 
exposure to EtO. None of the comments received by OSHA indicated that 
technology feasibility problems prevented affected businesses from 
complying with the EtO Standard.
    The Standard encouraged the development of improved sterilizers, 
which achieved compliance with the standard and cost less than other 
sterilizers. The newer equipment costs about half the cost of the older 
equipment with add-on controls. This reduced costs for all employers 
including small businesses.
    A 1995 Congressional Office of Technology Assessment study 
completed after the standard took effect concluded that the Feasibility 
Study, which OSHA performed before issuance of the standard, was 
accurate and well done.
    The agency has also reviewed the record and standard pursuant to 
E.O. 12866. Pursuant to that review it has reached the following 
    The EtO Standard remains both justified and necessary. As discussed 
in OSHA's Section 610 analysis, EtO poses significant health and safety 
risks to workers exposed to the substance. While the standard has 
resulted in dramatic reductions in occupational exposures to EtO, OSHA 
continues to document overexposures and non-compliance in the 
workplace. A study of Massachusetts hospitals demonstrated that 
enforcement actions were necessary before they came into compliance 
with the standard.
    The EtO Standard is compatible with other OSHA standards and is not 
inappropriately burdensome in the aggregate. No public comment 
questioned the compatibility of the EtO standard with Federal OSHA or 
state standards.
    The EtO Standard is compatible with E.O. 12866. The Executive Order 
essentially provides for a regulatory system that efficiently and 
effectively protects health and safety without imposing unacceptable or 
unreasonable costs on society. The regulations that are produced must 
be consistent, sensible, and understandable. This lookback review has 
received many comments supporting the standard's effectiveness in 
reducing occupational exposures to EtO. In addition, the industries 
that use EtO appear to be familiar with the standard and have adopted 
improved technology, use of substitutes, and other methods to improve 
efficiency. No evidence was submitted to the Docket or identified by 
OSHA in the course of this lookback review to suggest that the standard 
was imposing either a significant impact on a substantial number of 
small entities or that it was causing an excessive compliance burden. 
The EtO Standard is effective in achieving its mission. Uniform support 
for retaining the EtO standard is in the public record for this 
lookback review.
    Therefore, based on the comments and testimony of participants in 
this lookback review process and the studies and other evidence 
submitted to the public docket, OSHA concludes, as discussed in depth 
in "Regulatory Review of the Occupational Safety and Health 
Administration's Ethylene Oxide Standard" March 2005, that the 
Agency's Standard should be continued without change. The evidence also 
demonstrates that the Standard does not need to be rescinded or 
substantially amended to minimize significant impacts on a substantial 
number of small entities.
    OSHA also finds that the EtO Standard is necessary to protect 
employee health, is compatible with other OSHA standards, is not 
duplicative or in conflict with other Federal, state, or local 
government rules, is not inappropriately burdensome, and is consistent 
with the President's priorities and the principles of E.O. 12866. 
Further, no changes have occurred in technological, economic, or other 
factors that would warrant revision of the Standard at this time. No 
commenters recommended that the standard be repealed or made less 
    As a result of this lookback review and the comments received from 
participants, OSHA will enhance some of its compliance assistance 
materials. The enhancements may cover emergency requirements, medical 
surveillance and other areas.

    Signed at Washington, DC, this 12th day of April, 2005.
Jonathan L. Snare,
Acting Assistant Secretary of Labor.
[FR Doc. 05-8080 Filed 4-21-05; 8:45 am]