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  • ACOEM Comments on OSHA’s Proposed Beryllium Exposure Rule

    November 5, 2015

    OSHA Docket Office
    Docket No. OSHA — H005C–2006–0870
    U.S. Department of Labor
    Room N-2625
    200 Constitution Avenue, NW
    Washington, DC 20210

    To Whom It May Concern:

    The American College of Occupational and Environmental Medicine (ACOEM) would like to thank the Occupational Safety and Health Administration (OSHA) for the opportunity to comment on the Notice of Proposed Rulemaking — Occupational Exposure to Beryllium. A task force of ACOEM’s Council of Scientific Advisors prepared these comments. ACOEM believes that the protections envisioned by the draft language are a very substantial improvement over the current situation and should lead to a reduction in beryllium-associated illnesses. We urge OSHA to move expeditiously in issuing the final rule.

    Following are ACOEM’s comments on several of the issues for which the Agency requested responses beginning at 80 FR 47572:

    Risk Assessment and Significance of Risk
    Question 5. “OSHA preliminarily concluded that there is significant risk of material health impairment (lung cancer or CBD) from a working lifetime of occupational exposure to beryllium at the current TWA PEL of 2 mg/m3, which would be substantially reduced by the proposed TWA PEL of 0.2 mg/m3 and the alternative TWA PEL of 0.1 mg/m3. OSHA’s preliminary risk assessment also concludes that there is still significant risk of CBD and lung cancer at the proposed PEL and the alternative PELs, although substantially less than at the current PEL. Are these preliminary conclusions reasonable, based on the best available evidence? If not, please provide a detailed explanation of your position, including data to support your position and a detailed analysis of OSHA’s risk assessment if appropriate.”

    ACOEM Comment: ACOEM supports a lower PEL at 0.1 mcg/m3 (alternative standard #4). ACOEM submits that a lower PEL is clearly in the interests of workers’ health. CBD cases and deaths that have been documented at exposures in the range of the proposed 0.2 mcg/m3 PEL. While a PEL of 0.1 mcg/m3 will not be 100% protective against chronic beryllium disease (CBD) and cancer, it should reduce disease incidence. It should be noted that the ACGIH TLV is 0.05 mcg/m3.

    Question 8. “Has OSHA defined the scope of the proposed standard appropriately? Does it currently include employers who should not be covered, or exclude employers who should be covered by a comprehensive beryllium standard? Are you aware of employees in construction or maritime, or in general industry who deal with beryllium only as a trace contaminant, who may be at significant risk from occupational beryllium.”

    ACOEM Comment: ACOEM supports a broader scope for the standard to include the construction and maritime industries whenever airborne or dermal exposure to beryllium is a significant possibility (alternative standard #21). The experience of the Department of Energy facilities has clearly demonstrated that individuals in the building trades can be affected by beryllium. Multiple studies have demonstrated risk for workers who are considered dust disturbers, including those involved in demolition. It makes no sense to exempt certain employment sectors from protections against beryllium disease.

    Question 10. “Has OSHA defined CBD Diagnostic Center appropriately? In particular, should a CBD diagnostic center be required to analyze biological samples on-site, or should diagnostic centers be allowed to send samples offsite for analysis? Is the list of tests and procedures a CBD Diagnostic Center is required to be able to perform appropriate? Should any of the tests or procedures be removed from the definition? Should other tests or procedures be added to the definition? Please provide rationale and information supporting your comments.”

    ACOEM Comments:
    Beryllium work area: ACOEM does not agree with the existing definition as currently stated. Because the designation of “Beryllium Work Area” is not based on exposure levels (“regardless of the level of exposure”), because it is not specific to workplaces where beryllium is used and/or processed, and because airborne beryllium is essentially ubiquitous at very low levels, this designation would likely apply to most worksites regardless of work activity. We understand that the intent of this designation is to protect susceptible workers at beryllium facilities who might be routinely exposed to levels below the Action Level (e.g., secretaries, security guards). Accordingly, we recommend that this designation be applied specifically to worksites in which any beryllium or beryllium-containing materials are or have been processed using methods capable of generating dust or fume.

    CBD Diagnostic Center: ACOEM believes that the CBD diagnostic center does not have to perform the BE-LPT or BLLPT on-site.

    Exposure Monitoring
    Question 12. “Is it reasonable to allow discontinuation of monitoring based on one sample below the action level? Should more than one result below the action level be required to discontinue monitoring? (e) Work Areas and Regulated Areas The proposed standard would require employers to establish and maintain two types of areas: beryllium work areas, wherever employees are, or can reasonably be expected to be, exposed to any level of airborne beryllium; and regulated areas, wherever employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the TWA PEL or STEL. Employers are required to demarcate beryllium work areas, but are not required to restrict access to beryllium work areas or provide respiratory protection or other forms of PPE within work areas with exposures at or below the TWA PEL or STEL. Employers must also demarcate regulated areas, including posting warning signs; restrict access to regulated areas; and provide respiratory protection and other PPE within regulated areas.”

    ACOEM Comment: There is significant uncertainty associated with limited sample numbers, and unrecognized changes in the work environment can raise exposure levels; therefore, there is a risk of missing over-exposure, and this concern emphasizes the need for inclusive criteria for medical surveillance. ACOEM specifically opposes alternative standards 7 (PEL only) and 8 (raising trigger for ancillary standards).

    Personal Protective Clothing and Equipment
    Question 19. “The proposal requires PPE wherever work clothing or skin may become visibly contaminated with beryllium; where employees’ skin can reasonably be expected to be exposed to soluble beryllium compounds; or where employee exposure exceeds or can reasonably be expected to exceed the TWA PEL or STEL. The requirement to use PPE where work clothing or skin may become ‘‘visibly contaminated’’ with beryllium differs from prior standards, which do not require contamination to be visible in order for PPE to be required. Is ‘‘visibly contaminated’’ an appropriate trigger for PPE? Is there reason to require PPE where employees’ skin can be exposed to insoluble beryllium compounds? Please provide the basis for your response and any applicable supporting information.”

    ACOEM Comment: Protective clothing should be supplied whenever skin contact with either soluble or particulate beryllium is a possibility. Particulate beryllium can sensitize transdermally. The stipulation for "visible" contamination on clothing as a trigger for protective garments is ill-conceived, and protective clothing should be provided whenever the action level is exceeded or skin contamination with particulate or soluble beryllium is possible.

    Medical Surveillance
    Question 24. “Please review paragraph (k) of the proposed rule, Medical Surveillance, and comment on the frequency and contents of medical surveillance in the proposed rule. Is 30 days from initial assignment a reasonable time at which to provide a medical exam? Should there be a requirement for beryllium sensitization testing at time of employment? Should there be a requirement for beryllium sensitization testing at an employee’s exit exam, regardless of when the employee’s most recent sensitization test was administered? Are the tests required and the testing frequencies specified appropriate? Should sensitized employees have the opportunity to be examined at a CBD Diagnostic Center more than once following a confirmed positive BeLPT? Are there additional tests or alternate testing schedules you would suggest? Should the skin be examined for signs and symptoms of beryllium exposure or other medical issues, as well as for breaks and wounds? Please explain the basis for your position and provide data or studies if applicable.”

    ACOEM Comments:
    1910.1024(k) Medical Surveillance (1)(i). The criteria for inclusion in medical surveillance should be revised to clearly indicate the requirement to offer a baseline examination and LPT to individuals assigned to a regulated work area.

    (k)(1)(i) ACOEM recommends that OSHA provide additional provisions for workers with possible beryllium-related skin disease. One option would be to include a new paragraph (k)(1)(i)(E) as follows:

    (E) For each employee who works in a regulated area who develops new onset dermatitis, so long as the condition is not responsive to routine medical treatment and responds to removal from beryllium exposure or is found on skin biopsy to have non-caseating granulomata, unless the employee also qualifies for an examination under paragraph (k)(1)(i)(A), (B), or (C) of this section and additional medical evaluation as though they had 2 positive Be-LPTs.

    (k)(1)(i)(D) ACOEM endorses alternative standard #15 and submits that the threshold for inclusion in medical surveillance should be exposure at or above the action level of 0.1 mcg/m3. Sensitization and CBD have been demonstrated at this level of exposure, and the use of the AL as a trigger for medical surveillance would be consistent with some other OSHA standards.

    (k)(2)(ii). Recognizing that the physical examination has limited sensitivity for the detection of most beryllium associated diseases, ACOEM's opinion is that the medical surveillance examination may be offered every two years unless symptoms develop. Accordingly, ACOEM supports alternative standard #20.

    (k)(3)(ii)(E)(2). ACOEM submits that individuals with a borderline Be-LPT test should also qualify for a repeat test within 30 days. The combination of one borderline and one positive or 3 borderlines should qualify an individual for referral to a CBD diagnostic center without characterizing the individual as “sensitized.” The rationale for this position is that, even given a relatively low prevalence of CBD (say 1%), the positive predictive value of the test is quite high under these circumstances.

    (k)(3)(ii)(F) ACOEM does not support the provision of the helical CT scan for the detection of beryllium-related cancer and does not think there is sufficient evidence that the potential benefit has been adequately demonstrated in this situation. In addition, there are potential harms from the radiation dose associated with this procedure. As a point of clarification, the helical CT is also not the preferred CT algorithm for detection of CBD.

    Question 25. “Please provide comments on the proposed requirements regarding referral of a sensitized employee to a CBD diagnostic center, which specify referral to a diagnostic center ‘‘mutually agreed upon’’ by the employer and employee. Is this requirement for mutual agreement necessary and appropriate? How should a diagnostic center be chosen if the employee and employer cannot come to agreement? Should OSHA consider alternate language, such as referral for CBD?”

    ACOEM Comment: The standard should provide for follow-up visits for sensitized employees (and for those with other qualifying Be-LPT results) at CBD diagnostic center and additional medical tests at intervals determined by the consulting physician. Workers should not be required to rely on self-pay, group medical insurance, or a successful workers' compensation claim in order to periodically receive advanced medical testing to monitor possible development of beryllium-associated illness.

    Question 26. “In the proposed rule, OSHA specifies that all medical examinations and procedures required by the standard must be performed by or under the direction of a licensed physician. Are physicians available in your geographic area to provide medical surveillance to workers who are covered by the proposed rule? Are other licensed health care professionals available to provide medical surveillance? Do you have access to other qualified personnel such as qualified X-ray technicians, and pulmonary specialists? Should the proposal be amended to allow examination by, or under the direction of, a physician or other licensed health care professional (PLHCP)? Please explain your position. Please note what you consider your geographic area in responding to this question.”

    ACOEM Comment: ACOEM agrees that the complexity of the medical issues should require that the medical examinations and procedures be performed either by or under the direction of a licensed physician. Beryllium associated diseases are potentially multi-organ with variable pattern and timing of onset. Their diagnosis and management depends on use of complex medical reasoning that includes inputs from a careful occupational history, interpretation of immunoassays, imaging studies, and other tests. It is unlikely that other health professionals will be able to manage these assessments with acceptable quality.

    Question 29. “Should OSHA require the clinical laboratories performing the BeLPT to be accredited by the College of American Pathologists or another accreditation organization approved under the Clinical Laboratory Improvement Amendments (CLIA)? What other standards, if any, should be required for clinical laboratories providing the BeLPT?”

    ACOEM Comment: ACOEM proposes that LPT testing should be performed in laboratories that are accredited by the College of American Pathologists or its equivalent and also recommends that these laboratories periodically undergo BE-LPT proficiency testing.

    Question 30. “Are there now, or are there being developed, alternative tests to the BeLPT you would suggest? Please explain the reasons for your suggestion. How should alternative tests for beryllium sensitization be evaluated and validated? How should OSHA determine whether a test for beryllium sensitization is more reliable and accurate than the BeLPT? Please see Appendix A to the proposed standard for a discussion of the accuracy of the BeLPT.”

    ACOEM Comment: ACOEM notes with interest the development of the ELISPOT spot test to detect beryllium stimulated interferon production. ACOEM does not recommend it as an alternative test at this time. Prospective comparisons for efficiency should be conducted between Be-LPT and the ELISPOT in the field setting.

    ACOEM also offers the following comment on OSHA’s use of the terms “continuum” and “spectrum” in the preamble to refer to beryllium associated diseases: ACOEM recommends that OSHA revise its use of the terms “continuum” and “spectrum” in its description of the relationship between BeS and CBD as contrasted to its description of the various signs and symptoms associated with CBD. It is correct to refer to the symptoms of CBD as points on a continuum, but it is not correct to describe BeS and CBD in that way. It is well recognized that some workers with BeS do not develop CBD. ACOEM recommends that OSHA use the term “spectrum” to refer to the constellation of beryllium-associated conditions.

    ACOEM is an organization of more than 4,000 occupational physicians and other health care professionals, which provides leadership to promote optimal health and safety of workers, workplaces, and environments.

    Thank you for your consideration of our comments. Please do not hesitate to contact me or Patrick O’Connor, ACOEM’s Director of Government Affairs, at 202/223-6222, should you have any questions.


    Mark A. Roberts, MD, PhD, MPH, FACOEM