MEMORANDUM FOR REGIONAL ADMINISTRATORS |
|
THRU: |
JOHN B. MILES Director Directorate of Field Operations |
|
FROM: |
EDWARD J. BAIER Director Directorate of Technical support |
|
SUBJECT: |
Health Hazard Information - 1,3-Butadiene |
A major ingredient used in manufacturing synthetic rubber and resin,
1,3-butadiene, has been found to cause cancer in laboratory rodents. About
70,000 workers in the chemical and rubber industries are potentially exposed
to this compound.
The present OSHA standard for 1,3-butadiene, codified as 29 CFR 1910.1000,
Table Z-1, was adopted in 1971 under the authority of Section 6(a) of the
Occupational Safety and Health Act. This OSHA standard for 1,3-butadiene is
an 8-hour time-weighted average exposure limit of 1,000 parts per million
parts of air (1,000 ppm).
In 1976, the International Institute of Synthetic Rubber Producers, Inc.
(IISRP) commissioned 90-day and 2 year inhalation toxicology studies on rats
at Hazelton Laboratories, United Kingdom. In 1980, a teratology study on
rats was initiated at Hazelton Laboratories, U.K. The carcinogenicity study
was completed in November 1981. IISRP also commissioned an epidemiologic
study of synthetic rubber workers. The study was performed by the School of
Public Health, Johns Hopkins University, and the findings were reported in
June 1982.
In 1981, the National Toxicology Program (NTP) initiated a laboratory animal
(mice) inhalation study at Battelle Northwest. The final report is not yet
available. Results of the studies commissioned by IISRP demonstrated the
potential for 1,3-butadiene to cause cancer and reproductive effects in rats
of exposure levels of 1,000 and 8,000 ppm. Preliminary findings from the NTP
study confirm the carcinogenic potential at exposure levels of 625 and 1,250
ppm in mice.
The retrospective mortality study contracted at John Hopkins University
assessed the mortality experience of workers in production plants in the
United States and Canada during the period 1943-1979. The final study
population was 13,920 workers. The study results showed all cancer mortality
to be less than that for the general population. There was no statistically
significant elevation in standardized mortality ratios for specific cancers.
There were no statistically significant findings based on latency analysis.
No attempt was made to include work environment exposure information in the
analyses because information was not reliable or not available.
In addition to the above information, OSHA is aware that Meinhandt et. al.
(Scand. J. Environ Health 8, 1982, 250-259) has published results of an
environmental epidemiologic investigation of the styrene-butadiene rubber
industry. No statistically significant excess in cause-specific mortality
was reported in the study.
The results of the rodent toxicology studies triggered concern within OSHA
regarding the adequacy of the existing OSHA exposure standard for
1,3-butadiene. On September 15, 1983, representatives from unions, industry,
government and the university community concerned with the adequacy of the
existing OSHA standard met at OSHA headquarters in Washington, D.C. The
meeting was held in order to discuss the significance of available
information as it is gathered. On January 5, OSHA published an announcement
in the Federal Register stating that OSHA is joining with the Environmental
Protection Agency (EPA) in requesting that interested parties submit to the
public docket data and comments relevant to the determination of risks
associated with potential adverse health effects resulting from 1,3-butadiene
exposure. The comment period ended on March 5, 1984. A Federal Register
notice announcing the extension of the comment period is being prepared.
IISRP has submitted worker exposure data for 1,3-butadiene which were
collected in eight North American polymer plants between 1978 and 1984. The
total number of measurements determined was 1,672 for a variety of
1,3-butadiene occupational exposures. Worker exposures were 25 ppm or less
in 97.5 percent of the 8-hour time-weighted average exposures evaluated.
Levels for 94.7 percent of the exposures measured were 10 ppm or less.
It is
our understanding that additional exposure information will be provided in
the near future as a result of EPA contractor and National Institute for
Occupational Safety and Health (NIOSH) workplaces studies.
SUMMARY
OSHA has identified potential adverse health effects that may result from
worker exposure to 1,3-butadiene which require additional evaluation. These
include carcinogenicity and reproductive effects. OSHA is seeking both to
determine the risks associated with the present OSHA standard and to obtain
additional information on current worker exposure levels. OSHA is working
with NTP, EPA, NIOSH and the National Cancer Institute (NCI) in this regard.
Currently available information suggests a need to reevaluate the existing
1,000 ppm standard. However, the currently available information also
requires further evaluation and scientific study before a reasonable risk
assessment can be performed. The data and analyses presently available do
not indicate that a grave danger exists at the exposure levels (less than 1%
of the PEL) that are found currently in the workplace.
OSHA is committed to a detailed review of all currently available
information as well as information received in response to the Federal
Register notice of January 5. The agency will determine, after it receives
and evaluates this information, whether 1,3-butadiene should be added to
OSHA's regulatory agenda.
We would appreciate any further information on the subject including current
worker exposure levels and available engineering control technologies as well
as work practices. The information should be sent, as soon as possible, to:
OSHA Docket Office
Docket No. H-041
U.S. Department of Labor - OSHA
200 Constitution Avenue, N.W.
Room S-6212
Washington, D.C. 20210
Tel: (202) 523-7894
Please assure that all Area Offices will receive this information.
|