July 7, 1997

Robert S. Rhodes, MD, President
American College of Occupational and Environmental Medicine
55 West Seegers Road
Arlington Heights, IL 60005-3919

Dear Dr. Rhodes:

Thank you for your letter of June 9, 1997, which petitioned for modification of the Occupational Safety and Health Administration's (OSHA) Methylene Chloride (MC) Standard. We wish to assure you that OSHA is aware of the concerns you raise regarding the medical surveillance provisions of the MC rule. However, for the reasons described below, OSHA does not intend to modify the MC standard at this time.

In OSHA's MC standard, paragraph (j)(3) requires that all medical procedures be performed by a physician or other licensed health care professional, defined as "an individual whose legally permitted scope of practice (i.e., license, registration, or certification) allows him or her to independently provide or be delegated the responsibility to provide some or all of the health care services required by paragraph (j) of the standard." Use of this phrase is designed to increase the flexibility and performance orientation of the standard. OSHA is increasingly taking initiatives, as encouraged by Congress and the Office of Management and Budget, to replace regulatory requirements that specify the precise means by which employers must meet a particular goal with performance standards that define a goal and let employers meet it in the most efficient ways their circumstances allow. In this case, by increasing the performance orientation of the rule (specifying only that a provider be licensed to perform a service rather than have a specific type of license or academic credential), OSHA has minimized the costs of medical surveillance, ensured a high quality of service, and improved access to services. Moreover, by specifying that health care professionals can only act within the scope of their state licensure, OSHA has ensured that medical evaluations will be conducted by qualified individuals.

OSHA has long considered the issue of whether and how to identify the particular professionals who are to perform the various medical surveillance tasks required by its health standards. The Agency recognizes that the personnel able to provide the required medical surveillance may vary from state to state, depending on state licensing laws. Under the final rule, an employer has the flexibility to retain the services of a range of qualified licensed health care professionals, thus potentially reducing costs, increasing flexibility, and allowing employers to identify those professionals with the greatest facility in assessing and counseling individual employees, diagnosing occupational diseases, and discerning patterns and trends in morbidity and mortality. In future rulemakings, OSHA may attempt, with the cooperation of all interested stakeholders, to provide guidance on which licensed health care professionals are the most appropriate to perform the program components required by the Agency's standards, including assessment, diagnosis, medical management, and data aggregation and review.

OSHA is concerned that you have interpreted the standard to infer that the Agency is pre-empting the rights of states to decide the scope of practice of health care professionals. In fact, language was added, in part, to do exactly the opposite: to specifically respect the rights of states to determine the scope of practice of health care professionals. In some states, a physician is the only health care practitioner who is licensed to conduct or supervise many of the medical surveillance tasks under the MC standard. The definition in the final standard in no way changes the practice in those states. On the other hand, there are many states in which licensed health care professionals other than physicians (for example, nurse practitioners) have been empowered by state law to independently conduct many of the tasks in the MC medical surveillance provisions. In those states, requiring that medical surveillance be conducted by or under the supervision of a physician would be unduly restrictive. The language in the MC standard follows the state determination regarding the appropriate scope of practice for health care professionals providing the medical surveillance services.

As you note, pre-1990 OSHA health standards provide that medical surveillance must be conducted by a physician. However, there has been a growing societal trend in recent years to reduce medical costs and improve access to health care by expanding the role of non-physician health care providers. OSHA's post-1990 health standards, such as the Bloodborne Pathogens standard (issued in 1991) and the 1,3-butadiene standard (issued in 1996) reflect this trend. They also reflect OSHA's continuing efforts to make standards more performance-oriented and cost-effective.

In addition, you contend that this provision will create an incentive for employers to hire unqualified licensed health care professionals. To the contrary, OSHA believes that this provision may serve to increase the quality and level of expertise of the health professionals conducting the medical surveillance program, by encouraging the use of physician or non-physician specialists in occupational health in place of or in conjunction with non-specialist physicians. In addition, under the MC standard, no person may conduct any part of the medical surveillance unless specifically licensed to do so independently or through delegation by a licensed individual.

Finally, as you point out, the proposed rule's medical surveillance provisions did not specifically allow, as does the final rule, non-physician professionals to conduct such surveillance. However, the rulemaking process is intended to allow the Agency to learn ways in which its proposed rules can be improved, and it is therefore common for final rules to differ from those that were proposed. As discussed above, the change from the proposed rule to allow some medical surveillance tasks to be conducted by non-physician licensed professionals as well as physicians was designed to make the final rule more cost-effective and performance-oriented. OSHA does not believe that such a change required reopening of the record for additional notice and comment.

For these reasons, the Agency has decided not to grant your petition for modification of the MC standard. Thank you for bringing your concerns to our attention. Your interest in occupational safety and health is greatly appreciated.

Sincerely,

Adam M. Finkel, Sc.D.

June 9, 1997

Mr. Greg Watchman
Acting Assistant Secretary of Labor for Occupational Safety and Health
United States Department of Labor
200 Constitution Ave. N.W., Room S2315
Washington, D.C. 20210

Dear Secretary Watchman:

Pursuant to 29 CFR 1910.3(a) (1996), the American College of Occupational and Environmental Medicine (ACOEM) submits the following petition for modification of the Occupational Safety and Health Administration (OSHA) standard for Occupational Exposure to Methylene Chloride, 29 CFR Parts 1910, 1915 and 1926, as published in the January 10, 1997 Federal Register at pages 1494 through 1611.

ACOEM specifically petitions for modification of paragraph (j)(3) of the methylene chloride (MC) standard. This paragraph, headed "Medical personnel," requires that all medical surveillance procedures be "performed by a physician or other licensed health care professional, as defined in paragraph (b) of this section." 62 Fed. Reg 1494, 1604 (1997)(emphasis added). ACOEM petitions that paragraph (j)(3) be replaced with the following:

(j)(3) Medical personnel. The employer shall ensure that all medical surveillance procedures are performed by, or under the supervision of, a licensed physician.

ACOEM also petitions for the deletion of all references to "physician or other health care professional" used throughout the standard and in the Appendices, and the replacement of this phrase with the term "licensed physician."

Furthermore, ACOEM petitions for modification of paragraph (b) headed, "Definitions." 62 Fed. Reg. 1494, 1601 (1997). ACOEM petitions that the definition for "Physician or other licensed health care professional" be deleted.

If unmodified, the rules governing medical surveillance under the OSHA standard for MC will allow under-qualified and under-trained health practitioners to make key diagnostic and treatment decisions. By allowing health care practitioners other than licensed physicians to make these decisions, OSHA has exceeded its authority and has preempted the right of the states to decide the scope of practice of health care practitioners. Currently, in almost every state, the physician is the only health care practitioner empowered to make a diagnosis and prescribe treatment.

Throughout the section of the standard dealing with medical surveillance there are mandatory functions that clearly require physician attention. For example, under paragraph (j)(9), a written medical opinion is required to be prepared for both the employer and employee:

• Paragraph (j)(9)(A) requires an opinion of whether the employee has any detected medical condition that increases his risk of material impairment from exposure to MC.

   

   

• Paragraph (j)(9)(D) requires a statement of the results of medical examinations of the employee and any conditions resulting from MC exposure which require further explanation or treatment.

   

   

• Paragraph (j)(9)(D)(ii) prevents revealing to the employer any findings or diagnosis that have no bearing on occupational exposure to MC. 62 Fed. Reg 1494, 1695 (1997).

The requirements under this paragraph involve assessment and planning for abnormal findings, second opinions, and final medical determinations that only licensed physicians are qualified by training, and certified by the state, to make. In fact, in the preamble to the proposed rule, OSHA states, "Clearly, a licensed physician is the appropriate person to supervise and evaluate a medical examination." 56 Fed. Reg. 57036 (1991). ACOEM asks that OSHA modify the final MC rule to return to this original position.

The MC standard as written is a radical departure from the other 21 substance specific health standards that contain a medical surveillance requirement. Previous health standards recognized that physicians are the only health care practitioners routinely trained in-depth in such areas as toxicology, clinical medicine, evaluation of surveillance results, diagnosing health conditions related to occupational exposures, and the disciplines related to prescribing appropriate treatment, including prescription medications, for any diagnosed condition. See Benzene, 29 CFR 1910.1028, and Formaldehyde, 29 CFR 1910.1048 (1996).

Because of the need to protect workers' health from the harmful effects of workplace exposure to industrial chemicals, and recognizing that the quality of care impacts on the health and safety of the worker, all of these standards require that medical surveillance be performed by or under the supervision of a licensed physician. The MC standard is no different and should also contain this requirement to protect employees from occupational exposures to hazardous and toxic materials.

This defect in the methylene chloride standard puts employees at risk from incorrect diagnosis and treatment. The standard creates an incentive for employers to cut corners by hiring any "licensed health care professional" to conduct the medical surveillance process, even though they may lack the qualifications and training to make an accurate assessment of the employees' health and the effects (or lack thereof) of exposure. For example, a practical nurse may be qualified to perform a medical test and record the results, but is in no way qualified to determine the significance of the result or prescribe appropriate treatment. This loophole is closed, and workers' health protected, if only licensed physicians are permitted to perform or supervise these activities.

The MC standard, with its weakened medical surveillance procedures, undermines OSHA's strong commitment to a safe and healthy work environment. Not only do we think this is the wrong direction for OSHA to be taking, we are astonished that the agency would implement such a drastic and unprecedented change of policy without any notice or opportunity for comment. In section IV of the proposed rule, entitled REQUEST FOR INFORMATION AND COMMENTS, no specific comments are sought concerning the use of other than licensed physicians under the medical surveillance provisions. 56 Fed. Reg. 57036 (1991). No indication was given by OSHA that a significant change in the personnel used to perform medical surveillance was being contemplated. Based on the fact that all prior OSHA health standards require the use of licensed physicians, there was no reason to believe that such a change would occur from the proposed rule to the final rule. Because of the significant impact this change has on the protection of worker health, comments should have been requested. The failure of OSHA to raise this issue for comment in the proposed rule constitutes reason enough for OSHA to modify the final standard and return to a requirement for the use of licensed physicians under the medical surveillance provisions.

ACOEM respectfully submits this petition to implement the foregoing modifications to the final MC standard. These changes will result in consistent medical surveillance requirements across all workplace health standards. By implementing these changes, OSHA will fulfill its mandate to protect the health of workers and ensure the safety of the workplace.

Sincerely,

Robert S. Rhodes, MD
President, American College of Occupational
and Environmental Medicine