Standard Interpretations - Table of Contents Standard Interpretations - Table of Contents
• Standard Number: 1910.1018; 1910.1029

August 19, 1996

William B. Patterson, M.D., M.P.H.
New England Health Center
66B Concord Street
Wilmington, MA 01887

Dear Dr. Patterson:

This letter is in response to your letter dated April 22, 1996, originally sent to the OSHA Boston Regional Office. Your concerns involved the chest X-ray and sputum cytology requirements under the medical surveillance section of the Arsenic standard (29 CFR 1910.1018). These same problems are also applicable to our Coke Oven Standard found in 29 CFR 1910.1029. These concerns are addressed in a July 22nd, 1996 Federal Register Notice (Volume 61 page 37849) in which the Agency has proposed to eliminate required sputum cytology testing and reduce required X-ray examinations from every six months to annually for both standards. Specifically, those standards currently call for medical examinations which contain elements that may not be the best recommended medical practice.

1. The medical examination in 29 CFR 1910.1018(n)(3)(ii) calls for annual chest X-rays, and X-rays every six months if the exposed employee is over the age of 45, and has been exposed over the action level for more than 10 years (5 or more years if employed in a regulated area under the 29 CFR 1910.1029(j)(3)(ii)).

2. The medical examination in 29 CFR 1910.1018(n)(2)(ii)(C) calls for annual sputum cytology, and sputum cytology every six months if the exposed employee is over the age of 45, and has been exposed over the action level for more than 10 years (5 or more years if employed in a regulated area under the 29 CFR 1910.1029(j)(2)(vii)).

OSHA has conducted a review and evaluation of the literature and current medical practices concerning the two elements. Based upon the review the Agency has proposed to modify those two elements as discussed above. The following interim guidance is provided pending completion of the rulemaking on this matter.

Chest X-rays:

Regarding the frequency of chest X-rays, the literature does not support the current provisions in the arsenic and coke oven emission standards with respect to semiannual X-ray tests. The Agency believes that the role of chest X-rays in the surveillance of high risk populations would be appropriately served if conducted annually instead of every six-months.

Sputum Cytology:

A review of the literature on recommended medical practice does not support the use of sputum cytology as an effective means of enhancing the early detection of lung cancer in workers exposed to arsenic or coke oven emissions. The Agency does not believe it is appropriate to require sputum cytology in the surveillance of these workers, although it may be useful on a case by case basis for clinical management.

Based upon the above information, CSHOs encountering inspection situations where semiannual chest X-rays and/or sputum cytology tests were not conducted in accordance with the requirements of the respective standards shall not issue citations for these elements provided:

1) All other elements of the required medical examinations were provided, and

2) at least annual chest X-rays were being provided to affected workers in lieu of semiannual chest X-rays.

If you have any questions please contact the Office of Health Compliance Assistance or the Office of Occupational Medicine at (202) 219-8036 or 219-5003, respectively.

Sincerely,

John B. Miles, Jr.
Director Directorate of Compliance Programs

1910.1018 INORGANIC ARSENIC

There is a requirement for a semi-annual sputum cytology examination for employees 45 years of age or older or with ten or more years of exposure over the action level. It is currently being proposed that this requirement be deleted from the medical surveillance requirements.

Presently, there are no available studies which address the efficacy of sputum cytology examinations as a screening tool for workers specifically exposed to inorganic arsenic. However, two randomized controlled studies have evaluated the benefit of sputum cytology examinations as a screening tool for lung cancer in a high risk group, namely male smokers age 45 years of age and older.(1,2) The two studies were the Johns Hopkins Lung Project(3) and the Memorial Sloan-Kettering Lung Project(4), both being part of the National Cancer Institute Cooperative Early Lung Cancer Detection Program. Together, the studies included 20,427 male smokers. These men were randomized to a dual-screen group (in which subjects underwent annual chest radiograph and sputum cytologic study every four months) or to a single-screen group (in which annual chest radiographic screening was performed.

Memorial Sloan-Kettering Lung Project

_____________________________________________________________________

Dual-Screen Group Radiograph-Only Group

_____________________________________________________________________

Number of Patients 5,072 4,968 Lung Cancers Detected 144 144 Resectability, % 53 51 5-Year Survival 35 35 Lung Cancer Deaths 90 92

_____________________________________________________________________

In the Johns Hopkins Lung Project, the eight-year survival in both groups was 20%. For both studies, there were no significant differences in the total number of lung cancer cases, the number of late-stage lung cancer cases, the number of resectable lung cancers, five and eight-year survival, and the number of lung cancer deaths between the dual-screen and single-screen groups. Therefore, sputum cytology did not add any benefit to a lung cancer screening program that already included annual chest x-rays.

False positive sputum cytology results can be as high as ten percent in patients with pulmonary infections and bronchial asthma.(5) False positive results can lead to extensive testing, expenses, and anxiety. A positive sputum cytology examination, with a negative chest x-ray, is usually followed by an examination of the oral cavity, the pharynx, and the larynx by both direct visualization and flexible fiberoptic laryngoscopy. If this is negative, then the lower respiratory tract is visualized by flexible fiberoptic bronchoscopy. Bronchial washings and biopsy are often included. In addition, imaging studies might be done, including computed tomography (CT scan) and magnetic resonance imaging (MRI). Such procedures, especially invasive ones, have inherent risks including death.(6)

The American Cancer Society's recommendations for early detection of cancer in asymptomatic persons does not include the use of sputum cytology examinations.(7) This decision was based on the lack of epidemiological evidence that would support the use of sputum cytology screening and the risks and costs associated with false positive exams.(8)

Therefore, since sputum cytology examination does not add any benefit to a lung cancer screening program that already includes annual chest x-rays and since false positive results can lead to unnecessary medical follow-up procedures, it is recommended that sputum cytology examinations be deleted from the medical surveillance requirements of this standard.

References:

1. Strauss GM, et. al. Chest x-ray screening improves outcome

in lung cancer: a reappraisal of randomized trials on lung cancer screening. Chest 107:270S-279S, June 1995.

2. Berlin NI, et. al. The National Cancer Institute cooperative

early lung cancer detection program. American Review of Respiratory Disease 130:545-49, 1984.

3. Tockman M. Survival and mortality form lung cancer in a screened

population: the Johns Hopkins study. Chest 89(suppl):324S-25S, 1986.

4. Melamed MR, et. al. Screening for early lung cancer: results

of the Memorial Sloan-Kettering study in New York. Chest 86:44-53, 1984.

5. Benpassat J, et. al. Predictive value of sputum cytology.

Thorax 42:165-169, 1987.

6. Credle WF, et. al. Complications of fiberoptic bronchoscopy.

American Review of Respiratory Disease 109:67-72, 1974.

7. Holleb AI, et. al. American Cancer Society Textbook of

Clinical Oncology, p. 155, American Cancer Society, 1991.

8. Holleb AI, et. al. American Cancer Society Textbook of

Clinical Oncology, p. 168-170, American Cancer Society, 1991.

1910.1029 COKE OVEN EMISSIONS

There is a requirement for a semi-annual chest x-ray for employees 45 years of age or older or with five or more years employment in the regulated area. It is currently being proposed that this requirement be changed to an annual chest x-ray in the medical surveillance requirements.

Presently, there are no large, randomized, and controlled studies available which address the efficacy of chest x-ray screening nor the proper interval of screening for workers specifically exposed to coke oven emissions. However, two randomized controlled studies have assessed the efficacy of chest x-ray screening in a group at high risk of developing lung cancer, namely male smokers 45 years of age and older.(1,2) These studies are the Mayo Lung Project(3,4) and a study from Czechoslovakia(5,6). Although neither study had an unscreened control group, both studies compared regular screening with periodic (every 4-6 months) chest radiographs in an experimental group with infrequent, sporadic, or in some cases no screening in a control group.

Mayo Lung Project Czechoslovak Study

Experimental Control Experimental Control

Group Group Group Group

--------------------------------------------------------------------

Number of Patients 4,618 4,593 3,172 3,174 Lung Cancers Detected 206 160 36 19 Resectability, % 46 32 25 15 Five-Year Survival 33 15 25 0 Lung Cancer Deaths 122 115 28 18

--------------------------------------------------------------------

Periodic chest x-rays led to increased detection of early-stage disease, increased rates of resectability, and improvements in lung cancer-specific survival. However, all of these outcomes are subject to lead-time and length bias(1). A reduction in lung cancer-specific mortality, an outcome which is not subject to such biases(1), was not demonstrated.

No study to date has compared chest x-ray screening for lung cancer with no screening at all in a prospective design with adequate follow-up time.(7) Thus, although the efficacy of chest x-ray screening can be questioned, no conclusive evidence exists to show that chest radiography screening does not lower lung cancer mortality(7). In fact, the American Thoracic Society recommends chest radiography screening in asymptomatic individuals with exposure to known or potential respiratory hazards.(8) The frequency of screening for workers exposed to respiratory hazards has not been determined by adequate epidemiological studies.

The risk of developing cancer from screening chest radiographs is extremely low. Radiaton exposure to the lung from a single posteroanterior and lateral chest radiograph is 0.02 rad.(9) It has been estimated that, at most, the upper limit of lifetime risk from 1.0 rad exposure is one cancer death per 10,000 persons, following a latency period of 10 to 40 years.(10)

Since large randomized controlled studies have shown that biannual chest radiography screenings show no benefit over sporadic annual screening, it would be beneficial to the worker to maintain medical surveillance without compromising the health of the individual. Therefore, chest radiography screening of high risk individuals such as coke oven workers should continue since no epidemiological studies exist to support the elimination of such a requirement.

References:

1. Strauss GM, et. al. Chest x-ray screening improves outcome in lung

cancer: a reaprraisal of randomised trials on lung cancer screening. Chest 107:270S-279S, June 1995.

2. Berlin Ni, et. al. The National Cancer Institute cooperative early

lung cancer detection program. American Review of Respriatory Diseases 130:545-49, 1984.

3. Fontana R, et. al. Lung cancer screening: the Mayo Program.

Journal of Occupational Medicine 28:746-50, 1986.

4. Fontana R. et. al. Screening for lung cancer, a critique of the

Mayo Lung Project. Cancer 67:1155-64, 1991.

5. Kubik A, Polak J. Lung cancer detection: results of a randomized

prospective study in Czechoslovakia. Cancer 57:2428-37, 1986.

6. Kubik A, et. al. Lack of benefit from simi-annual screening for

cancer of the lung: follow-up report of a randomized controlled trial on population of high risk males in Czechoslovakia. International Journal of Cancer 45:26-33, 1990.

7. U.S. Preventive Medicine Task Force. Guide to Clinical Preventive

Services: An Assessment of the Effectiveness of 169 Interventions, p. 67-70. Williams & Wilkens, Baltimore, MD, 1989.

8. American Thoracic Society. Surveillance for Respratory Hazards

in the Occupational Setting. Official ATS Statement. June, 1982.

9. Kereiakes JG, Rosenstein M. Handbook of radiation doses in

nuclear medicine and diagnostic x-ray. Boca Raton, Fla:

CRC Press, 1980.

10. Webster E. On the question of cancer induction by small

x-ray doses. AJR 137:647-66, 1981.

June 21, 1996

MEMORANDUM TO: JOHN B. MILES, JR., Director

Directorate of Compliance Programs

THROUGH: RUTH MCCULLY, Director Office of Health Compliance Assistance

FROM: JOHN T. PHILLIPS Regional Administrator

SUBJECT: Interpretation of Arsenic Standard

Attached is a letter from William B. Patterson, M.D., M.P.H., asking for a medical surveillance interpretation of the arsenic standard. A member of my staff, Ms. Shirley Boulware, called Dr. Melissa McDiarmid, Director of the Office of Medicine, for assistance. Dr. McDiarmid said the national office has received similar inquiries about the arsenic standard in the past. After having spoken to a number of people, she told Ms. Boulware that the arsenic standard interpretation on medical surveillance is a policy issue and would have to be addressed as such. Therefore, I am sending Dr. Patterson's letter to you for interpretation and further action.

If you have any questions, please call Robert B. Hooper, ARA/FSO or Ms. Boulware, at 617-565-7164, extensions 120 and 133 respectively. I have already informed Dr. Patterson of the anticipated delay of a response to his letter. Thank you for your assistance.

Attachment

April 30, 1996

William B. Patterson, M.D., M.P.H.
New England Health Center
66B Concord Street
Wilmington, Massachusetts 01887

Dear Dr. Patterson:

This is an interim response to your letter dated April 22, 1996, asking for information about medical surveillance under the arsenic standard.

First of all, your letter that you sent to me in January apparently never reached this office; none of my staff recalled seeing it. Thank you for sending it to me again.

I asked Melissa McDiarmid, M.D., Director of the Office of Occupational Medicine in our national office, for assistance in answering your questions about medical surveillance under the arsenic standard. Apparently, the national office has received similar letters about the arsenic standard. Dr. McDiarmid informed me that the agency is aware of the situation and is in the process of putting together an official response. She anticipates a response in May.

Meanwhile, if you have any further questions, please feel free to contact Ms. Shirley Boulware of my staff, at 617-565-7164, extension 133.

Yours very truly,

John T. Phillips
Regional Administrator

April 22, 1996

Mr. John T. Phillips
Regional Administrator OSHA
133 Portland Street
Boston, MA 02114

Dear Mr. Phillips:

On January 31, 1996, I sent you a letter regarding arsenic medical surveillance programs (copy enclosed). I would greatly appreciate your answering the questions which I posed to you in that letter, since a number of our clients are very interested in proper performance of medical surveillance under the OSHA Arsenic Standard.

Sincerely,

William B. Patterson, MD, MPH
President New England Occupational Health Services

enclosure

January 31, 1996

Mr. John T. Phillips
Regional Administrator OSHA
133 Portland Street
Boston, MA 02114

RE: Arsenic Standard

Dear Mr. Phillips:

As Occupational Medicine Consultant to a number of local high-tech firms, I am often called upon to evaluate and assist in the implementation of medical surveillance programs which comply with the OSHA Arsenic Standard. I note that the Arsenic Standard requires chest x-rays every year for individuals less than 45 years of age with fewer than ten years of exposure and every six months for all other covered employees. I also note that a sputum cytology examination is required biannually for older individuals with more than ten years of exposure.

As I read the medical literature, the specificity, sensitivity, clinical utility, and cost effectiveness of annual chest x-rays continue to be questioned. I am not aware of any data demonstrating that annual chest x-rays for individuals in the younger, low exposure group meet any of the generally accepted criteria for medical surveillance. Further, despite the Standard's optimistic approach to medical surveillance (alternating chest x-rays and sputum cytologies every three months), I am not aware that this type of aggressive screening program in a high risk population has been shown to be beneficial.

Several of our clients who use arsenic on a regular basis have comprehensive preventive programs, including control of employee exposures, biological monitoring, and annual medical examinations. They have questioned the usefulness and validity of performing periodic chest x-rays and sputum cytologies for some of the reasons noted above.

I would appreciate some thoughts and guidance from you regarding how OSHA approaches this problem of an apparent divergence between the OSHA standard and scientific recommendations. Is OSHA insistent on annual chest x-rays for all employees covered by the Arsenic Standard? If reasonable attempts to induce sputum in the older, exposed age group are unsuccessful, how must the company document compliance with this portion of the standard? Is there an instruction document to OSHA inspectors to aid in their evaluation of compliance? If so, is this available for sending to me?

Thank you in advance for your attention to these questions. Please contact me if I can provide any additional information regarding this.

Sincerely,

William B. Patterson, MD, MPH
President New England Occupational Health Servicess


Standard Interpretations - Table of Contents Standard Interpretations - Table of Contents