DEPARTMENT OF LABOR

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION

29 CFR Parts 1910 and 1926

[Docket No. H-057a]

RIN 1218-AB16

OCCUPATIONAL EXPOSURE TO CADMIUM

AGENCY: Occupational Safety and Health Administration (OSHA), Department of Labor.

ACTION: Notice of limited reopening of rulemaking record

SUMMARY: On February 6, 1990, OSHA published its proposed rule to regulate occupational exposure to cadmium (55 FR 4052). Public hearings on the proposal were held in Washington, D.C. and Denver in June and July 1990. The posthearing comment period closed on October 18, 1990. OSHA now reopens the rulemaking record for 45 days for the limited purpose of receiving the reports of two recent experiments concerning the solubility and carcinogenicity of cadmium sulfide and to invite written comment on the implications of these reports and on the underlying issues of the solubility (including photo-decomposition), bioavailability, toxicity, and carcinogenicity of cadmium sulfide and its relative potency compared to other cadmium compounds. OSHA also invites written comment on other submissions to the record that were made after the close of the posthearing comment period.

DATE: New evidence must be received or postmarked no later than October 18, 1991. Other information and written comments must be received or postmarked no later than November 2, 1991.

ADDRESSES: Information and comments should be sent in quadruplicate to: Docket Office, Docket H-057a, Room N2625, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, D.C. 20210. Comments limited to 10 pages or less may also be transmitted by facsimile to: 202-523-5046, provided that the original and four copies of the comment are sent to the Docket Officer immediately thereafter.

FOR FURTHER INFORMATION CONTACT: Mr. James F.Foster, Room N3647, Office of Information and Consumer Affairs, Occupational Safety and Health Administration, 200 Constitution Avenue NW., Washington, D.C. 20210. Telephone, (202) 523-8151.

SUPPLEMENTARY INFORMATION:

Background

On June 18, 1986, the Health Research Group ("HRG") of Public Citizen, joined by the International Chemical Workers Union ("ICWU"), petitioned the Occupational Safety and Health Administration ("OSHA") to issue an Emergency Temporary Standard ("ETS") for cadmium. On July 1, 1987, OSHA denied the petition for an ETS on the grounds that the record did not support findings that cadmium posed a "grave danger" as defined by the courts. However, at that time the Agency also determined that the current PELs were not sufficiently protective and that the Agency would proceed with a rulemaking under section 6(b) of the Occupational Safety and Health Act to promulgate a permanent rule to reduce occupational exposure to cadmium.

In July of 1989, petitioners, alleging unnecessary delay on OSHA's part, filed a petition for a Writ of Mandamus in the U.S. Court of Appeals for the D.C. Circuit seeking to compel the Agency to issue the proposed and final standards by specified dates. On October 20, 1989, the court ordered the case held in abeyance and ordered OSHA to file a report within three months on the status of the proposed rule and the date by which the Agency expected to issue a final rule. OSHA duly filed its status report, projecting publication of the proposal around the end of January 1990 and publication of the final cadmium rule within 24 months thereafter.

On February 6, 1990 OSHA published its proposed rule to regulate occupational exposure to cadmium (55 FR 4052). Thereafter, on February 12, 1990, the Court of Appeals indicated that it was satisfied with OSHA's compliance to date but noted: 1) that OSHA's projection of 24 months for publishing a final standard exceeded by six months the 18-month period previously projected by the Agency; and 2) that all parties agree that exposure to cadmium poses a serious risk to workers and that OSHA should therefore proceed expeditiously. Consequently, the court ordered that the case continue to be held in abeyance, pending further review, and further ordered OSHA to file with the court, every six months until the final rule is issued, a report indicating the status of the rulemaking and the date by which the Agency expects to issue a final rule.

A public hearing on the proposal was held in Washington, D.C. on June 5-13, 1990, and in Denver on July 17-19, 1990. A posthearing comment period of 90 days was established by the hearing officer, Administrative Law Judge Julius A. Johnson. On September 18, 1990, SCM Chemicals, Inc., a cadmium pigment manufacturer, moved to extend the posthearing comment period. SCM sought the extension to allow submission to the record of studies that were about to be initiated regarding the possible confounding effect of the alleged photo-decomposition (solubilization) of cadmium sulfide on the results of an important long term inhalation study of rats exposed to cadmium sulfide and other cadmium compounds (Glaser, U., et al., "Carcinogenicity and Toxicity of Four Cadmium Compounds Inhaled by Rats," Toxicological and Environmental Chemistry, Vol. 27, pp. 153-62, 1990). That study by Glaser et al. showed cadmium sulfide to be a lung carcinogen of approximately equal potency with other cadmium compounds. The follow-up studies were to test whether the evidence of equal potency might be attributable, in whole or in part, to the existence in the inhaled cadmium sulfide aerosol of cadmium ions that were produced by the prior photo- decomposition of cadmium sulfide in water in the presence of light. The SCM motion was denied by Judge Johnson. The post hearing comment period ended on October 18, 1990.

On April 22, 1991, the Dry Color Manufacturers' Association ("DCMA"), representing cadmium pigment manufacturers and users, filed a motion with Judge Johnson to reopen the hearing to allow cross examination of OSHA witnesses regarding the carcinogenicity of cadmium sulfide in light of the results of the completed follow-up studies, or alternatively to remove cadmium pigments from the current rulemaking. In its opposition to the motion, OSHA indicated that, in the interest of fairness and fully developing the record, the Agency would carry out a limited reopening of the record to allow submission of the results of the follow-up studies and written public comment on the studies and underlying issues. DCMA's motion was denied by the judge on May 13, 1991.

On May 24, 1991, Judge Johnson certified the record for the public hearing as closed. Thereafter, on June 17, 1991, DCMA moved for reconsideration of its previous motion. On July 5, 1991, OSHA denied the motion to reconsider. In its letter of denial, OSHA reiterated that the Agency would reopen the record for the limited purpose of receiving the final reports of the two recent studies and updated assessments by outside OSHA experts of those reports and their implications and to seek public comment on the new evidence and the underlying issues concerning cadmium sulfide.

OSHA then contracted with one of its experts at the hearing, Dr. G. Oberdorster, who is a co-author of one of the follow-up studies, and with one of the co-authors of the other study, Dr. U. Heinrich, to assess cadmium sulfide's solubility, bioavailability, toxicity, carcinogenicity and potency relative to other cadmium compounds in light of all the evidence, including their studies.

Reopening the Record

In order to complete the rulemaking record regarding the health effects of occupational exposure to cadmium sulfide, OSHA is now reopening the rulemaking record and placing in the record the final reports by Drs. Glaser, et al. and Konig et al. of the two follow-up solubilization studies (Exs. L-140-44 and L-140-27B, respectively) and the updated assessments by OSHA experts, Drs. Oberdorster and Heinrich (Exs. 141 and 142, respectively). The record is being reopened for the limited purpose of including in it these reports and assessments and seeking written comment from the public and interested parties on these new submissions and, more generally, on the underlying issues of cadmium sulfide's solubility (including photo-decomposition), bioavailability, toxicity, carcinogenicity and potency relative to other cadmium compounds.

Since OSHA is reopening the record, the Agency at this time also will allow public comment on the other evidence and comments that were submitted to the record after it had closed (Exs. L-131 through L-140), which were filed in the rulemaking docket as late comments and were not subject to public comment. Most of these submissions also deal with the cadmium sulfide issue. The remainder deal with a variety of other matters, ranging from concerns about the methodologies relied upon in several epidemiological studies of health effects associated with exposure to cadmium, to updates of documents already in the record, to reference materials for laboratory standardization.

Request for Comments

To complete the rulemaking record on the question of whether cadmium sulfide should be regulated like other cadmium compounds OSHA seeks public comment on: 1) the final 1991 reports by Glaser et al. and Konig et al. (Exs. L-140-44 and L-140-27B, respectively); 2) the assessments by Drs. Oberdorster and Heinrich (Exs. 141 and 142, respectively); and 3) the underlying issues of cadmium sulfide's solubility (including photo- decomposition), bioavailability, toxicity, carcinogenicity, and potency relative to other cadmium compounds. In addition, as indicated above, OSHA invites public comment on the other submissions to the record previously classified as late.

Evidence or comments already in the record or duplicative of what is already in the record should not be resubmitted. New evidence must be received or postmarked no later than October 18, 1991. Comments must be received or postmarked no later than November 2, 1991. All submissions should be sent in quadruplicate to the Docket Office, Docket H-057a, Occupational Safety and Health Administration, Room N2625, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, D.C. 20210 (202-523-7894), where the entire record is available for inspection and copying.

Authority

This document was prepared under the direction of Gerard F. Scannell, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue, NW, Washington, D.C. 20210.

It is issued under section 6(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655), Secretary of Labor's Order No. 1-90 (55 FR 9033) and 29 CFR Part 1911.

Signed at Washington, D.C., this 18th day of September, 1991.

Gerard F. Scannell
Assistant Secretary of Labor