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||Regulatory Flexibility Act Review of the Methylene Chloride Standard
[Federal Register: July 10, 2007 (Volume 72, Number 131)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2007-0024]
RIN 1218-AC 23
Regulatory Flexibility Act Review of the Methylene Chloride
AGENCY: Occupational Safety and Health Administration, Labor.
ACTION: Request for comments.
SUMMARY: The Occupational Safety and Health Administration (OSHA) is
conducting a review of its Methylene Chloride Standard under Section
610 of the Regulatory Flexibility Act and Section 5 of Executive Order
12866 on Regulatory Planning and Review. In 1997, OSHA promulgated the
Standard to protect workers from occupational exposure to methylene
chloride. The purpose of this review is to determine whether there are
ways to modify this Standard to reduce regulatory burden on small
business and to improve its effectiveness. Written comments on these
and other relevant issues are welcomed.
DATES: Written comments to OSHA must be sent or postmarked by October
ADDRESSES: You may submit comments by any of the following methods:
Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions on-line for making
Fax: If your submissions, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
Mail, hand delivery, express mail, messenger and courier service:
You must submit three copies of your comments and attachments to the
OSHA Docket Office, Docket No. OSHA-2007-0024, U.S. Department of
Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC 20210.
Deliveries (hand, express mail, messenger and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 8:15 a.m.-4:45 p.m., Eastern Time.
Instructions: All submissions must include the Agency name and the
OSHA docket number for this rulemaking, (OSHA-2007-0024). Submissions
are placed in the public docket without change and may be available
online at http://www.regulations.gov. Therefore, do not include private
materials such as social security numbers.
Docket: To read or download submissions or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket are listed in the http://www.regulations.gov
index; however, some information (e.g.,
copyrighted material) is not publicly available to read or download
through the Web site. All submissions, including copyrighted material,
are available for inspection and copying at the OSHA Docket Office.
FOR FURTHER INFORMATION CONTACT: Joanna Dizikes Friedrich, Directorate
of Evaluation and Analysis, Occupational Safety and Health
Administration, Room N3641, 200 Constitution Avenue, NW., Washington,
DC 20210, Telephone (202) 693-1939, Fax (202) 693-1641.
OSHA adopted the first Methylene Chloride (MC) Standard in 1971
pursuant to Section 6(a) of the OSHA Act, 29 U.S.C. 655, from an
existing Walsh-Healy Federal Standard. The original MC Standard was
intended to protect workers from injury to the neurological system and
from irritation. It required employers to ensure that employee exposure
did not exceed 500 parts per million (ppm) as an 8-hour time weighted
average (TWA), 1,000 ppm as a ceiling concentration, and 2,000 ppm as a
maximum peak for a person not to exceed five minutes in any two hours
(29 CFR 2920.1000, Table Z-2). In February 1985, the National
Toxicology Program reported the results of animal testing studies
indicating that MC is a potential cancer causing agent. In July 1985,
several unions petitioned OSHA to reduce worker exposure to MC. In
response, OSHA agreed to commence development of a permanent standard,
issuing an Advanced Notice of Proposed Rulemaking on November 24, 1986
(51 FR 42257).
Based on its review of human and animal data, OSHA determined that
the existing permissible exposure limit (PEL) for MC did not adequately
protect employee health, and on November 7, 1991, OSHA issued a Notice
of Proposed Rulemaking (NPRM) to address the significant risk of MC
induced health effects (56 FR 57036). OSHA also presented the proposal
to the Advisory Committee on Construction Safety and Health (ACCSH).
Based on input from ACCSH, OSHA issued a supplemental notice (57 FR
36964, August 17, 1992) which raised the MC use, exposure, and control
issues specific to the construction industry. OSHA conducted informal
public hearings in 1992, reopened the record in 1994 for comments to
address engineering controls and carcinogenicity issues, and reopened
the record again in 1995 to request public input on the Halogenated
Solvents Industry Alliance studies addressing the use of animal data to
estimate human cancer risk from MC.
On January 10, 1997, OSHA promulgated the Methylene Chloride (MC)
Standard as 29 CFR 1910.1052 (62 FR 1494). OSHA concluded that MC
exposure created a significant risk of cancer and that 25 ppm was the
lowest feasible level. There is extensive discussion of these issues
and risk assessment issues in the final preamble.
The Standard covers occupational exposures to MC in all workplaces
in general industry, shipyard employment, and construction. Employers
are required to ensure that no employee is exposed to an airborne
concentration of MC in excess of 25 ppm as an 8-hour TWA, or short-term
exposure limit (STEL) in excess of 125 ppm during a sampling period of
15 minutes. The action level for a concentration of airborne MC is 12.5
ppm calculated as an 8-hour TWA. Reaching or exceeding the action level
signals that the employer must begin compliance activities, such as
exposure monitoring and medical surveillance.
The Standard also requires the establishment of a regulated area
and procedures for determining employee exposure to MC. The employer is
required to notify employees of monitoring results and to allow
employees or their designated representative to observe monitoring.
Employers also must establish a medical surveillance program for
employees exposed to MC. The Standard provides specific requirements
depending on the nature of the exposure and health status of the
employee. If a medical professional determines that exposure to MC may
aggravate or contribute to an employee's existing skin, heart, liver,
or neurological disease, the Standard provides for temporary medical
removal and protection of benefits during removal.
The Standard provides that employers must control exposures to MC
to the PEL or below using engineering controls and work practices as
the primary methods, unless the employer can demonstrate that these
controls are infeasible. In these cases, respirators are permitted in
combination with engineering controls and work practices. The Standard
also provides minimum requirements for respiratory protection. However,
air filtration respirators are not very effective for MC. Finally, the
Standard includes requirements for protective clothing and equipment,
maintaining records of exposure measurements and medical surveillance,
providing information and training to employees, and providing
facilities for washing MC off of persons or clothing.
The Standard had phased-in start-up dates commencing on April 10,
1997. In response to petitions, OSHA delayed until August 31, 1998 the
requirement to use respirators to achieve the PEL and to December 10,
1998 the requirement to achieve the PEL and STEL through engineering
Methylene chloride is a powerful solvent with a number of uses.
Major uses include metal degreasing and aircraft paint removal. It is
used to strip finishes from furniture prior to refinishing, a use
carried out by very small businesses. MC is used in the manufacturing
of some plastics, adhesives, inks, and ink solvents. It also is used as
the expansion agent in the manufacture of flexible polyurethane foam,
and to manufacture polycarbonates. Another major, but diminishing, use
is in the manufacture of film base. Other uses of MC are as an aerosol
in spray cans, as a cleaning agent for semiconductors, and in the
manufacture of some pesticides and pharmaceuticals.
OSHA is reviewing the MC Standard under Section 610 of the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.) and Section 5 of
Executive Order 12866 (58 FR 51735, Oct 4, 1993).
The purpose of a review under Section 610 of the Regulatory
``(S)hall be to determine whether such rules should be continued
without change, or should be amended or rescinded, consistent with the
stated objectives of applicable statutes, to minimize any significant
impact of the rules upon a substantial number of such small entities.''
``[T]he 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 area affected by the rule.''
The review requirements of Section 5 of Executive Order 12866
``To reduce the regulatory burden on the American people, their
families, their communities, their state, local and tribal governments,
and 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 this Executive
Order, within applicable law; and to otherwise improve the
effectiveness of existing regulations.''
Requests for Comments
An important step in the review process involves the gathering and
analysis of information from affected persons about their experience
with the rule and any material changes in circumstances since issuance
of the rule. This notice requests written comments on the continuing
need for the MC Standard, its small business impacts, its effectiveness
in protecting workers and all other issues raised by Section 610 of the
Act and Section 5 of the Executive Order. It would be particularly
helpful for commenters to suggest how the applicability or requirements
could be changed or tailored to reduce the burden on employers while
maintaining employee protection. Comments concerning the following
subjects also would assist the Agency in determining whether to retain
the Standard unchanged, to initiate rulemaking for purposes of revision
or rescission, and/or to develop improved compliance assistance.
New Developments and Compliance
1. Do any provisions of the MC Standard at 29 CFR 1910.1052, such
as medical surveillance or respiratory protection, need to be updated
as a result of recent technological or scientific developments?
2. In cases where firms fail to comply with the MC Standard, is
non-compliance more commonly the result of (1) a lack of information
(e.g. about the dangers or the requirements), (2) inadequate
supervision, (3) cost pressures, or (4) other factors? How could OSHA
encourage improved compliance?
3. Are OSHA's MC requirements known to all firms that use MC,
including small firms and firms that use MC only occasionally? How
could awareness be increased for such firms?
4. Have better respirator filters been developed for MC? Are there
actions OSHA or NIOSH could take to encourage the development of better
5. Have safer alternatives been developed for high exposure uses
such as foam blowing?
6. Have small furniture refinishers implemented the low cost
engineering controls developed by NIOSH? Are there ways OSHA could
improve outreach to these small businesses?
7. Have new studies been completed since 1996 on the health effects
Costs and Impacts
8. How many employees are exposed to MC, generally, or in your
business; what are current exposures, and how much have they been
reduced since 1996? Please provide data.
9. Does any part of the MC Standard impose an unnecessary or
disproportionate burden to small businesses, or to industry in general?
How might OSHA modify the MC requirements to reduce costs without
jeopardizing protections to workers?
10. How much does it cost annually to comply with specific
provisions of the MC Standard (e.g., exposure monitoring, medical
surveillance, etc.)? Provide data if possible.
11. How have changes in technology, the economy, or other factors
affected the amount of MC used, the use of substitutes, and compliance
costs associated with the MC Standard since 1997?
12. Are any provisions of the MC Standard unclear, needlessly
complex, or duplicative?
13. Have standards relating to MC issued by OSHA, EPA, other
Federal agencies, or States caused overlap problems. If so, how could
these issues be addressed to reduce the burden on industry without
reducing worker protection?
Comments must be submitted by October 9, 2007. Comments should be
submitted to the addresses and in the manner specified at the beginning
of the notice.
Authority: This document was prepared under the direction of
Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational
Safety and Health, 200 Constitution Avenue, NW., Washington, DC
20210. It is issued under Section 610 of the Regulatory Flexibility
Act (5 U.S.C. 610) and Section 5 of Executive Order 12866 (58 FR
51735, October 4 1993).
Signed at Washington, DC on July 2, 2007.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. E7-13208 Filed 7-9-07; 8:45 am]
BILLING CODE 4510-26-P