Notice of Availability of the Regulatory Flexibility Act Review of the Occupational Health Standard for Ethylene Oxide, 20807-20809 [05-8080]
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20807
Rules and Regulations
Federal Register
Vol. 70, No. 77
Friday, April 22, 2005
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
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
Occupational Safety and Health
Administration, Department of Labor.
ACTION: Notice of availability.
AGENCY:
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
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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 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
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;
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(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
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20808
Federal Register / Vol. 70, No. 77 / Friday, April 22, 2005 / Rules and Regulations
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.
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15:26 Apr 21, 2005
Jkt 205001
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 noncompliance 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
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Fmt 4700
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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.
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Federal Register / Vol. 70, No. 77 / Friday, April 22, 2005 / Rules and Regulations
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]
BILLING CODE 4510–26–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[CGD09–05–009]
RIN 1625–AA00
Safety Zone; Chicago Sanitary and
Ship Canal, Chicago, IL
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is
establishing a safety zone around the
tank barge EMC423 during salvage
operations. This safety zone is necessary
to ensure the safety of workers and
divers during salvage operations of the
tank barge EMC423. The temporary
safety zone prohibits persons or vessels
from entering the zone unless
authorized by the Captain of the Port
Chicago or the designated on-scene
representative.
This rule is effective from 5 p.m.
on April 5, 2005, until 5 p.m on May 31,
2005.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of the docket (CGD09–
05–009], and are available for inspection
or copying at Commanding Officer, U.S.
Coast Guard Marine Safety Office
Chicago, 215 W. 83rd Street Suite D,
Burr Ridge, IL 60527, between 8 a.m.
and 3 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT:
LTJG Cameron Land, U.S. Coast Guard
Marine Safety Office Chicago, at (630)
986–2155.
SUPPLEMENTARY INFORMATION:
DATES:
Regulatory Information
We did not publish a notice of
proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the
Coast Guard finds that good cause exists
for not publishing an NPRM. This safety
zone is temporary in nature and limited
time existed for an NPRM. Under 5
U.S.C. 553(d)(3), the Coast Guard finds
that good cause exists for making this
rule effective less than 30 days after
publication in the Federal Register.
Delaying this rule would be
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15:26 Apr 21, 2005
Jkt 205001
impracticable and contrary to public
interest as boating season is resuming
and immediate action is necessary to
clear the barge from the canal and
perform clean up of the surrounding
area; further, immediate action is
necessary to ensure the safety of persons
and vessels during the salvage
operations and to prevent possible loss
of life or property. During the
enforcement of this safety zone,
comments will be accepted and
reviewed and may result in a
modification to the rule.
Background and Purpose
On January 19, 2005, the tank barge
EMC423 was involved in a marine
casualty on the Chicago Sanitary and
Ship Canal (CSSC) at Mile Marker 317.5.
The barge sustained an explosion and
partially sank with a full load of
clarified slurry oil on board. Salvage
and recovery operations are underway.
With the change in weather and
increase in recreational vessel traffic in
the area, the Captain of the Port Chicago
finds it necessary to implement
operational restrictions and control
vessel traffic through the area to protect
response workers, vessels transiting the
zone, and to maintain the integrity of
the site.
Discussion of Rule
This rule establishes a safety zone
from bank-to-bank beginning at the
Cicero Avenue Bridge at Mile Marker
317.3 and ending at the Belt Railroad
Bridge at Mile Marker 317.5 on the
Chicago Sanitary and Ship Canal.
Vessels will not be allowed to enter
the safety zone, without the express
permission of the Captain of the Port
Chicago or the designated on-scene
representative. It is anticipated that
controlled passage of vessels will be
possible on a case-by-case basis.
Barges transiting the area will be
limited to dry cargo, 35 foot wide with
drafts not exceeding 9-feet. Up bound
tows are limited to one barge. Down
bound tows are limited to one loaded
barge or two empty barges. All down
bound tows require a bow assist boat.
All commercial and recreational
vessels must contact the Coast Guard
Forward Command Post via VHF–FM
Channel 19 or land line at 630–336–
0291 to request permission to transit
through the safety zone.
Regulatory Evaluation
This rule is not a ‘‘significant
regulatory action’’ under section 3(f) of
Executive Order 12866, Regulatory
Planning and Review, and does not
require an assessment of potential costs
and benefits under section 6(a)(3) of that
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20809
Order. The Office of Management and
Budget has not reviewed it under that
Order. It is not ‘‘significant’’ under the
regulatory policies and procedures of
the Department of Homeland Security
(DHS).
We expect the economic impact of
this rule to be so minimal that a full
Regulatory Evaluation under the
regulatory policies and procedures of
DHS is unnecessary.
This finding is based on the relatively
small percentage of vessels that would
fall within the applicability of the
regulation, the relatively small size of
the limited access area around the
EMC423 tank barge, the minimal
amount of time that vessels will be
restricted when the zone is being
enforced. In addition, vessels that will
need to enter the zone may request
permission on a case-by-case basis from
the Captain of the Port or the designated
on-scene representatives.
Small Entities
Under the Regulatory Flexibility Act
(5 U.S.C. 601–612), we have considered
whether this rule would have a
significant economic impact on a
substantial number of small entities.
The term ‘‘small entities’’ comprises
small businesses, not-for-profit
organizations that are independently
owned and operated and are not
dominant in their fields, and
governmental jurisdictions with
populations of less than 50,000.
The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have
a significant economic impact on a
substantial number of small entities.
This rule affects the following
entities, some of which might be small
entities: The owners or operators of
vessels intending to transit through the
safety zone in and around the sunken
barge.
This rule would not have a significant
impact on a substantial number of small
entities because the restrictions affect
only a limited area for a brief amount of
time as this safety zone is effective only
when salvage operations on the tank
barge EMC423 is underway. Further,
transit through the zone may be
permitted with proper authorization
from the Captain of the Port Chicago or
his designated representative.
Additionally, the opportunity to engage
in recreational activities outside the
limits of the safety zone will not be
disrupted.
If you think that your business,
organization, or governmental
jurisdiction qualifies as a small entity
and that this rule would have a
significant economic impact on it,
please submit a comment (see
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]]>Agencies
[Federal Register Volume 70, Number 77 (Friday, April 22, 2005)]
[Rules and Regulations]
[Pages 20807-20809]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8080]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 70, No. 77 / Friday, April 22, 2005 / Rules
and Regulations
[[Page 20807]]
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.
-----------------------------------------------------------------------
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 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 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
[[Page 20808]]
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.
[[Page 20809]]
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]
BILLING CODE 4510-26-P
