[Federal Register: April 22, 2005 (Volume 70, Number 77)][Rules and Regulations] [Page 20807-20809]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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Rules and Regulations
Federal Register
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DEPARTMENT OF LABOR
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
Labor.
ACTION: Notice of availability.
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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
clarification.
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
entities."
"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
provisions.
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
conclusions:
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
protective.
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]
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