Regulations (Preambles to Final Rules) - Table of Contents|
| Record Type:||Occupational Exposure to Lead (November 1978)|
| Title:||Section 4 - IV. Summary and Explanation of the Standard|
IV. SUMMARY AND EXPLANATION OF THE STANDARD
The following sections discuss the individual requirements of the standard. Each section includes an analysis of the record evidence and the policy considerations underlying the decisions adopted pertaining to specific provisions of the standard. To the extent appropriate, the requirements in this standard are similar to requirements in other OSHA health standards and reflect OSHA's regulatory policy for comprehensive health protection of workers.
Each provision is an integral part of the comprehensive health program contained in this standard and as such provides a discrete but necessary contribution to the overall objective of the standard. Because of this, the benefits attributable to any specific provision can not be quantified and compared to its costs. For example, the training and education provision provides an essential function in assisting workers to recognize hazards and to minimize lead absorption by means within their control, i.e., better hygiene and work practices. This provision does not, however, provide any quantifiable benefits apart from the complex of other provisions which also minimize absorption because the contribution of poor hygiene or work practices, as percentage of total absorption, varies among individuals and is thus not determinable.
On the other hand, OSHA has assessed the costs of individual provisions (see Ex. 26; Ex. 22; Ex. 127) and has minimized costs to the extent possible without compromising the level of health protection and the integrity of the standard. OSHA has accomplished this by decreasing the frequency of periodically recurring requirements (e.g., air monitoring) or by providing a certain condition at which the obligation begins (e.g., an action level, the PEL, or a minimum duration of exposure).
In many cases, the standard does not create new costs for employers because the obligations already preexisted the final standard (e.g., current OSHA standards for respirators, personal protective equipment, hygiene facilities, engineering controls (29 CFR Part 1910)) or because employers have voluntarily instituted them as part of a comprehensive industrial hygiene program. OSHA thus believes the standard has been constructed in the most cost efficient manner and that the cost burdens imposed on employers are reasonable.
A. SCOPE AND APPLICATION: PARAGRAPH (a)
This standard for occupation exposure to lead is applicable to all employment and places of employment over which OSHA has statutory jurisdiction and in which lead, in any amount, is present in an occupationally related context. Exposure of employees to the ambient environment which may contain small concentrations of lead is not subject to this standard; however, where the source of lead is employment related, all exposure to lead is covered by the standard. The lead to which this standard applies is defined to include metallic lead, all inorganic lead compounds, and organic lead soaps. All of these substances are covered within the scope of a single standard because they generally react in a chemically and toxicologically similar manner in the human body. On the other hand, most organic lead compounds, except for organic lead soaps, have varying degrees of toxicity or have toxicological properties different than the inorganic group,(1) and thus are excluded from the scope of this standard. Some of these excluded compounds are covered by existing OSHA standards,(2) and others will be treated in separate standards to be developed in the future.
__________ Footnote(1) E.g., tetraethyl and tetramethyl lead are absorbed through the skin, unlike the inorganic compounds. See Documentation of the Threshold Limit Values for Substances in Workroom Air, American Conference of Governmental Industrial Hygienists, 3rd ed., 1971, 3rd printing, 1976, pp. 251-54. Footnote(2) Tetraethyl lead has a permissible exposure limit of 0.075 mg (as Pb)/m(3) and tetramethyl lead a permissible exposure limit of 0.07 mg (as Pb)/m(3), both as an 8-hour TWA, 29 CFR 1910.1000 Table Z-1.
Some covered compounds may be covered by this and one or more other OSHA standards. Lead chromate, for example, is covered under this comprehensive standard for lead as well as under the permissible exposure limit for chromic acid and chromates in Table Z-2 of 1910.1000, 29 CFR. Lead arsenate is covered under this standard and the standard for inorganic arsenic, 1910.1018. The requirements of each standard would apply to the extent applicable.
It should be recognized that although this standard may have general applicability to a particular employer or workplace, almost all of the obligations in the standard are predicated on an initial determination of certain minimum lead exposure conditions. For example, the requirements for periodic environment monitoring and medical surveillance apply only if employees are exposed to airborne lead in excess of the action level (30 ug/m(3)); employers whose employees are exposed below the action level are not required to conduct periodic monitoring or medical surveillance or to comply with most other provisions of the standard. This distinction is made in order to differentiate between more hazardous and less hazardous work operations and impose obligations commensurate to the degree of hazard present. For a more complete discussion of each particular requirement, see following paragraphs (C) through (R).
The notice of proposed rulemaking stated that the standard would apply to all industries covered by the Act, including general industry, construction and maritime and that corresponding standards for maritime and construction industries in Parts 1915-1918 and 1926 and in Subpart b of Part 1910, 29 CFR, would be superseded if they were determined to be not as effective as the final standard.
Several parties to the rulemaking contended that the construction industry should be exempt from coverage of the standard or that the standard should have special provisions for the construction industry because of the inherently different nature of construction employment as compared to industrial employment. (Ex. 3(30); 3(64); 3(98); 3(130); and 381A; Tr. 7290-7341.) The primary reasons cited to support exemption of the construction industry are the infeasibility (technical and economic) of compliance with certain provisions of the standard and the apparent purposelessness of others given the facts that the nature of construction work (1) often exposes employees to lead for very brief periods of time; (2) requires the employee and his tools to move from place to place, resulting in varying exposure conditions; and (3) has a high number of temporary employees.(3) These factors are claimed to impact on the construction industry's ability to comply with the standard's provisions in the following ways:
__________ Footnote(3) Construction work has a high turnover rate (300-600 percent (Tr. 7292; Ex. 3(30), p. 11), and construction subcontractors commonly hire local craftsmen through local unions for brief, specified periods. (Tr. 7297, 7301.)
1. "Exposure determinations and environmental monitoring." Environmental monitoring is not claimed to be infeasible other than where the length of the job could be shorter than the time it could take for air samples to be taken and analyzed (Tr. 7293; 7309-10; Ex. 3(64), p. 3).(4) It is claimed, however, that the mobility of the worker and the impermanence of the worksite renders the environmental monitoring requirements useless in the construction context because use as a historical record of exposure, is primarily based upon "the degree to which the results of the monitored activity can be related to some future repetition of that activity." (Ex. 3(30), p. 3.) In a construction environment, the contaminant source and exposure levels are often unique in any given task at any given time, and the air monitoring data derived can not serve its primary purpose of evaluating the need and efficiency of engineering controls and other protective measures triggered by the result of air monitoring.
__________ Footnote(4) The Council of Construction Employers states that "large construction companies use air monitoring techniques to determine toxic concentrations of airborne contaminants. There is no doubt that such techniques are available and can readily provide useful information..." (Ex. 3(64), p. 2)
2. "Methods of compliance." Engineering controls are contended to be inherently not feasible for certain construction activities, such as abrasive blasting or certain mobile activities. It is also claimed that on short-term jobs amortization of some controls, e.g., a conditioned-air ventilation system, would not be economically feasible. Technological and cost considerations aside, the time to design, procure and install such a system might exceed the entire time to complete the whole construction job. (Ex. 3(64), p. 4; Ex. 3(30), p. 4-6.)
3. "Hygiene facilities." On remote construction sites, minimal amounts of water may be available, and the use of mobile, self-contained facilities providing lockers, change rooms, showers, etc. would probably be economically prohibitive, especially for short duration jobs. (Ex. 3(64), p. 7.)
4. "Medical surveillance and MRP." Medical monitoring, medical removal and MRP requirements are also claimed to be unworkable. Because initial medical surveillance and periodic follow-up is predicated upon air monitoring results, the shortcomings of air monitoring for the construction industry, as discussed above, undermines the medical programs' effectiveness. The temporary worker may thus not get a medical exam or blood test until after the lab results of air sampling return, and follow-ups may be due long after he leaves the job. The need to protect the worker who begins employment with elevated blood lead levels may then only be ascertained after employment has been terminated. Also, high turnover rates and minimum medical personnel in remote and nonurban areas tend to aggravate the time problem.
OSHA has considered all the evidence in the rulemaking record on this issue and has concluded that there is insufficient evidence to satisfactorily resolve all the issues raised with respect to applicability of this standard to the construction industry. Construction is a diverse activity about which no valid generalizations can be drawn concerning the nature of lead exposure, the duration of a project, or the duration of an employer-employee relationship, and the record does not support drawing rational distinctions between groups that can feasibly be covered by the standard and groups that cannot. OSHA's own contractor on the EIS suggested that "the feasibility of applying the various provisions of the standard should be examined before including the construction industry in the scope of the standard." (Ex. 65B, p. 31,) Accordingly, OSHA intends to utilize the expertise of the Construction Advisory Committee and will request that it review the rulemaking record and make recommendations on the most appropriate way the lead standard can be applied to the construction industry. These recommendations will then become the basis for a proposed modification to part 1926.
OSHA has determined that the final lead standard would be more effective than corresponding standards for the maritime industries because, as a comprehensive health standard integrating air monitoring, medical surveillance, training and other requirements, it would provide greater protection to employees exposed to lead than that provided by the current maritime standards. Unlike the construction industry, representatives from the maritime industries who participated in the rulemaking did not claim that the standard should not be applicable to maritime activities. In fact, the Shipbuilders Council of America, and industry trade association, stated that compliance with the proposed standard was feasible even though it objected to specific provisions. (Ex. 230) Specifically, the new standard would supersede references to the 1970 TLV's in sections 1915.11, 1915.21, and 1917.11. The TLV for lead in 1970 was 200 ug/m(3) and to not supersede the current maritime standard would clearly allow a less protective, and hence less effective, standard to apply to the maritime industry. In addition, there are general standards for the maritime industries which, while not specifically applicable to lead exposure, would apply when lead exposure occurs in those industries. Where provisions in those standards clearly conflict with the new standard, the provisions of the new standard are intended to apply (e.g., 1915.23(a)(4)); however, where the present maritime standards are more specific or require additional protective action, they shall not be superseded. Examples of the latter case are in 1915.31(c), which deals with welding, cutting, or heating of toxic metals and sets forth specific work practices when these activities are performed. These sections would still apply, along with the new lead standard, but only to the extent they do not conflict with the new standard.
Finally, this standard does not apply to agricultural operations, standards for which are found in Part 1928, since OSHA has not proposed to cover agricultural operations and no comments were received on this issue.
B. DEFINITIONS: PARAGRAPH (b)
The final standard has deleted, as unnecessary, two definitions contained in the proposal. The definition of action level has been added to the final standard.
C. PERMISSIBLE EXPOSURE LIMIT (PEL); PARAGRAPH (c)
The final standard has a permissible exposure limit of 50 ug/m(3) as an 8-hour, time-weighted average.(5) This is the highest level of lead in air to which an employee may permissibly be exposed, exposure being defined as the actual concentration of airborne lead in an employee's breathing zone. Thus, the methods by which the employer chooses to reduce an employee's exposure to lead are not relevant to a determination of whether the PEL has been exceeded. The standard requires that the PEL be complied with immediately and at all times whether by engineering controls, work practices (including administrative controls), or respirators. A second obligation exists in the "Methods of Compliance" provision, paragraph (e) of the regulation, which requires engineering and work practices controls to be implemented according to a schedule to attain compliance with the PEL, and a violation of this paragraph may exist if the required means are not used to achieve permissible limits.
__________ Footnote(5) The rationale for choosing this level as the PEL is discussed in part III and Attachment B of this preamble.
The PEL is an eight-hour average of exposure for any work day. If respiratory protection is permissible being used to comply with the PEL and all of the requirements relating to selection, fitting, and maintenance of respirators are met, the employee needs to wear the respirator only for a period of time that, when averaged with periods of time the respirator is not worn, will result in a TWA exposure below permissible limits. For this purpose, the employee's exposure level when a respirator is worn may be considered to be the airborne concentration, without regard to the respirator, divided by the protection factor of the respirator. For example, if an employee is exposed to 100 ug/m(3) for 8 hours without a respirator, he would have to wear a respirator with a protection factor of 10 for about 4.4 hours or with a protection factor of 60 for about 4.1 hours, in order to comply with the PEL.
Of course, a class of respirator more protective than required by paragraph (f) may be selected, and if selected, would reduce the amount of time a respirator would need to be worn.
OSHA recognizes that workshifts can extend beyond the regular 8-hour period as the result of overtime or other alterations of the work schedule. This extension of worktime also extends the time during which the employee is exposed. The effects of this additional exposure time must be considered in arriving at a permissible level of exposure. For the purpose of calculating such a level, the relationship of concentration and length of time of exposure has been assumed to be linear. As the exposure time increases, the factor of concentration multiplied by time (C X T) should remain constant. As a result, it is believed that by equating exposure with the 8-hour time-weighted average, reasonable assurance of maintaining a safe exposure level is retained.
The final standard contains a formula by which adjustments to the permissible exposure limit can be made due to overtime. For example, if an employee is exposed to lead for 10 hours, the permissible limit, as a 10 hour average, would be 400/10 or 40 ug/m(3).
The proposed standard expressed the PEL as and 8-hour, time-weighted average "based on a 40-hour week." This has been deleted to avoid ambiguity since it was misconstrued by some commenters as a conversion of the PEL to a 40-hour average.
Information was also presented during the rulemaking proceeding regarding the variation in solubility and toxicity of different lead compounds. (Ex. 3(4), (57), (59), (67), (103), (107); Ex. 80; Ex. 234(16); Ex. 234(22); Ex. 247 A and B; Ex. 311A.) The key issue which emerged is whether the final standard should differentiate between different lead compounds in the establishment of permissible exposure limits.
Stanley D. Koremus, Deputy Assistant Secretary of the Interior, advocated the tolerance of some lead compounds at higher airborne concentrations. Koremus pointed out that some lead compounds, particularly lead sulfide which is common to the majority of lead ores, are virtually insoluble in biological tissue. He calls it "inconsistent" to institute the same low exposure limits for lead compounds which "would not result in excess blood lead" (Ex. 3(57), p. 2) as the others which would result in elevated blood leads.
D.A. Bissonnette, corporate industrial hygienist for PACCAR, Inc., advanced precisely the same complaints about the proposed lead standard. Bissonnette said the standard failed to take into account the different degrees of toxicity of lead in its different forms, citing the availability of the lead ion for absorption, the physical characteristics of the compound, and the route of absorption as distinguishing characteristics. (Ex. 3(59).) Bissonnette pointed specifically to the paint industry where the lead compounds used in paint pigments are "relatively insoluble." When paint is sprayed, the lead is "suspended and encapsulated in the paint mist" rendering it much less toxic than lead fumes or dust, according to Bissonnette. He stated that this explains why painters highly exposed to lead still exhibit normal blood lead levels. (Ex. 3(59), p. 1.) Most of the other arguments presented on this point reflected the view expressed by St. Joe Minerals Corp. that lead sulfide is absorbed little by man, if at all. St. Joe's D. H. Berlsterm claimed that lead sulfide "does not pose a significant adverse health problem and should be specifically exempted" from the lead standard. (Ex. 3(107). p. 1.) After evaluating industry claims that solubility and other factors of lead toxicity should be incorporated into the PEL, OSHA does not believe that the final standard poses what Bissonnette called "an unnecessary administrative and economic burden" on the less toxic lead compound industries. (Ex. 3(59), p. 2.) Several factors lead to this conclusion. Decreasing the airborne exposure reduces the amount of lead available for ingestion. Second, with the exception of lead sulfide, almost all lead to which employees covered by this standard will be exposed (e.g., lead fume, lead oxides) is relatively soluble. Most employees exposed to lead sulfide are mine and mill workers who fall under the jurisdiction of the Mine Safety and Health Administration and are not covered by OSHA standards. Only the few employees involved in the handling of ore and concentrates at lead smelters will be exposed to lead sulfide and many of them may also be exposed to other, more soluble forms of lead such as recycled flue dusts, drosses, etc. (Ex. 26, p. 5-3.) With regard to paint, not enough is known about the biological response to paint particulates (Tr. 1203) for OSHA to assume that exposure to lead-based paints are less toxic. Bissonnette's suggestion that painters' blood lead levels are normal despite high air lead levels because of lower toxicity is perhaps better explained by the fact that painters always wear respirators as protection from toxic vapors of solvents in the paint. (Tr. 1200.) Another factor suggested by participants is the particle size of the lead aerosol. Particle size affects the respirability and hence absorption of lead into the blood. However, nonrespirable particles may also be absorbed into the blood through direct ingestion or from swallowing nonrespired particles trapped on the mucous membranes in the respiratory tract. (Ex. 439A, p. 3-12.) The rate of absorption in the gut is clearly different than in the lung. OSHA agrees that particle size is relevant to the determination of a PEL and accounted for particle size in developing its air-lead to blood-lead relationship.
D. EXPOSURE MONITORING: PARAGRAPH (d)
The monitoring requirements of the final standard are imposed pursuant to section 6(b)(7) of the Act which mandates that standards promulgated under section 6(b) shall, where appropriate, "provide for monitoring or measuring of employee exposure at such locations and intervals, and in such manner as may be necessary for the protection of employees." The primary purpose of monitoring is to identify the sources of lead emission and to determine the extent of employee lead exposure. This will enable the employer to select proper control methods and to evaluate the effectiveness of the selected methods. Additionally, monitoring enables employers to notify employees when their exposure levels exceed permissible limits, as required by section 8(c)(3) of the Act, and provides information necessary to the examining physician.
Paragraph (d) of the regulation contains provisions for monitoring employee exposure to airborne lead without regard to the use of respirators. The final standard is essentially unchanged from the proposal except for three differences: (1) the initial determination of employee exposure must be based, at least in part, on air sampling and analysis, (2) periodic monitoring must include full-shift personal samples, and (3) the monitoring frequency is reduced.
The proposed standard would have required all employers to make an initial determination of whether any employee might be exposed to lead in excess of the action level. The basis of this determination for most employers did not include exposure monitoring. Only employers in certain industries known to have high lead exposure would have been required to monitor. The purpose of this requirement was to minimize the burden on employers where limited exposure to lead existed.
OSHA has reassessed this provision and decided that employers in all industries where lead is present in an occupational context should perform a minimal amount of exposure monitoring because it is the only precise method of determining lead-in-air concentrations and because it cannot be confidently predicted that lead exposures exceed the action level in only certain industries.
In its criteria document on lead, NIOSH identified 113 occupations or trades in which exposure to inorganic lead is possible. (Ex. 1, p. x-3.) The preliminary technological feasibility and economic impact analysis identified and collected information on 46 industries, representing at least 57 SIC codes, where employee exposure to lead is believed to occur. (Ex. 22.) However, because of the changing usage of lead in industry and the widely varied trades where exposure occurs, there is no reporting system in the United States to analyze the prevalence of lead poisoning and no precise measure of the extent of lead exposure. (Ex. 1, p. III-1.) For these reasons, it is important for each employer in whose workplace lead is present or used in an occupational context to make an initial determination of potential employee exposure based on a reliable and accurate method. To exclude all employers except those in traditionally high exposure industries from initial monitoring (as the proposed standard would have done) is to fail to recognize the need to accurately identify and measure all occupational sources of lead exposure.
The initial monitoring requirement is minimal in that it only requires monitoring of a representative sample of the employees believed to have the highest exposure levels. If these measurements indicate exposure below the action level, no further monitoring is required except where subsequent process or control changes would trigger a redetermination pursuant to paragraph (d)(7). If any employee is determined to be at or above the action level, then full-scale representative monitoring for all exposed employees is required.
In conducting the monitoring of employee exposures, the standard does not require that each individual employee's exposure level be measured. Although individual measurement is the ultimate indicator of an employee's exposure, OSHA believes that a requirement for individual measurement may be too burdensome, and that representative monitoring will adequately insure that the worker's exposure is maintained within the requirements of this standard. In establishments having more than one work operation involving the use of lead, in order for monitoring to be representative, it must be performed for each type of employee exposure within each operation. It should be noted that the requirement for representative monitoring does not preclude an employer from taking individual exposure measurements of each of his employees; individual measurements are certainly considered to be representative; however, representative monitoring merely establishes the minimum that the employer must meet.
OSHA disagrees with testimony which suggests that little or no confidence can be placed in determinations of employee exposure which are not based on an actual measurement of the exposure of each individual employee. (Tr. 6073.) If the representative employee chosen is, in fact, representative and a sampling protocol utilizing full-shift samples is used, OSHA believes this will be adequate in ascertaining employee exposure without being unduly burdensome. (Tr. 91-92.) Accordingly, the standard requires that the measurements be made by monitoring which is representative of each employee's exposure to lead over a full shift period without regard to the use of respirators. A full-shift sample is considered to be at least 7 hours long; this provides a sufficiently long sampling period while allowing time for equipment set-up and calibration. (Ex. 3(12), p. 4; Tr. 3626) The objective of environmental monitoring is twofold: first, full shift personal sampling will enable the employer to determine an individual employee's exposure to airborne concentrations of lead.(6) Individual monitoring information combined with biological monitoring data and clinical evaluation form the basis for ascertaining the lead-related health status of an individual worker.
__________ Footnote(6) OSHA recognizes that there will be day-to-day variability in airborne lead exposure experienced by a single employee. The permissible exposure limit is a maximum allowable value which is not to be exceeded; hence exposure must be controlled to an average value well below the permissible exposure limit in order to remain in compliance. This consideration forms the basis for OSHA's 95 percent confidence level requirements. (Ex. 314; Ex. 235; Ex. 150 A, pp. 30-32.)
For example, if a worker had high blood lead level but a low air lead exposure as determined by individual sampling, other sources of lead exposure (ingestion, non-occupational sources, etc.) would be suspected. The physician could make use of this information to ascertain and correct the associated problem.
Second, thorough environmental monitoring also enables the employer to determine the source of lead emission, the efficacy of control technology, and progress achieved during implementation of controls. In industries with high lead exposure, a comprehensive industrial hygiene survey may be required to determine the nature and extent of the lead exposure problem. This survey may require far more than a single full shift personal sample. Multiple area and personal samples may be necessary and a variety of sampling times may be needed to determine precisely the source of emission. Short-term samples may determine ceiling values in a markedly fluctuating environment, whereas continuous area sampling may be required in relatively stable situations.
Thus environmental monitoring serves two different but related functions. The monitoring requirements of this section reflects these different goals. The requirement of full shift personal sampling is mandatory for two reasons: First, it enables the employer to determine whether he is in compliance with the action level and/or the PEL, and second, to obtain data on the individual employee which may be used in conjunction with biological monitoring to better insure that an individual suffer no loss of health from other sources of lead.
The standard also requires that air monitoring data obtained to define the sources of emission and to assist in the development of the compliance plan be contained in the compliance plan. This data is necessary in order to determine what environmental controls will be required to achieve compliance and will enable OSHA to fully evaluate the proposed compliance plan.
The final standard reduces the frequency of periodic monitoring from monthly to quarterly when the PEL is exceeded and from quarterly to semi-annually when the action level is exceeded. This was favored by both industry (Ex. 3 (125)) and labor (Ex. 343, pp. 83-84) representatives. OSHA believes that accurate and representative sampling can be achieved by this schedule while reducing the economic costs of sampling between 50 percent and 66 percent.
Finally, the standard requires that the initial determination be made within 30 days of the effective date and the initial monitoring to be conducted and the results obtained within 90-days of the effective date of the standard. OSHA believes that these periods, in addition to the 90 day delayed effective date, is sufficient to enable employers to secure sampling equipment, take sufficient samples and obtain the results. Moreover, the standard permits employers, who have monitored within the last year as many have (Ex. 26, pp. 5-9, 5-35, 5-67), to utilize these measurements for purposes of compliance with the initial monitoring requirements, provided that the sampling and analytical method used meets the accuracy and confidence levels of this standard and provided that the employer maintains a record of these measurements and notifies employees of their exposure levels.
E. METHODS OF COMPLIANCE: PARAGRAPH (e)
The final standard requires employers to institute engineering controls and work practices, including administrative controls, according to a specific implementation schedule to reduce employee exposure to lead below the PEL. For some industries, interim levels are established which the employer must achieve solely by means of engineering and work practice controls. During the interim period before full compliance with the PEL in this manner is required and thereafter where engineering controls and work practices are not sufficient to comply with the PEL, they must be supplemented with appropriate respiratory protection. The standard also requires the employer whose initial monitoring reveals that employee exposure exceeds the PEL to develop a written compliance plan which is intended to promote rational planning and implementation of the employer's compliance efforts within the time permitted. The written plan also will enable OSHA and affected employees and their representatives to monitor the employer's progress toward compliance. Finally, if mechanical ventilation or administrative controls are used, some specific requirements are set forth.
In order to comply with the PEL, and employer will need to conduct an industrial hygiene survey, including environmental sampling, to identify sources of lead exposure and then devise methods to reduce exposure to within permissible limits. Employees covered by this standard are generally exposed to airborne lead particulate either when it is generated or released into the air directly from a production process or work operation or when it is dispersed after setting on floors, rafters, or other surfaces, including the worker's body and clothes. Methods commonly employed by industrial hygienists to control these exposures fall into three basic categories: engineering controls, work practice controls, including administrative controls, and personal protective equipment.
Several comments, including one from California's Occupational Safety and Health Administration, suggested the the terms "engineering controls," "work practice controls" and "administrative controls" are not understood by many employers and employees and need definition. (Ex. 3(31), p. 1.) These terms admittedly do not have precise meaning and often overlap, and the following is an attempt to set forth the meanings of these terms as they are commonly understood in the industrial hygiene community and used in this regulation.
"Engineering controls" employ mechanical means or process redesign to eliminate, contain, divert, dilute, or collect lead emissions at their source. Examples of this type of control include process isolation or enclosure; employee isolation (excluding respirators) or enclosure; closed material handling systems; product substitution or process redesign to eliminate the contaminant; and dilution or exhaust ventilation. "Work practice controls" or "work practices" accomplish the same results as engineering controls, but rely upon employees to repeatedly perform certain activities in a specified manner so that airborne lead concentrations are eliminated or reduced. This may be accomplished as simply as instructing employees to keep lids on containers, to clean up spills immediately, or to observe required hygiene practices. Good work practices are often required in conjunction with engineering controls; for example, where employees perform an operation under an exhaust hood, they must perform their work in such a way as to maximize the efficiency of the ventilation equipment.
Work practices also incorporate administrative controls within their scope. Administrative controls simply involve moving the employee to a place of lower exposure or reducing his work hours so that his daily, time-weighted average exposure is reduced. This type of control method does not act in any way on the source of the emissions.
Finally, personal protective equipment is a method of exposure control that isolates the employee from the emission source. Respirators are the primary type of personal protective equipment used when the concern is protection from an inhaled air contaminant.
The priority of control methods required by this standard, i.e., use of respiratory protection only as a supplement to engineering controls and work practices or as an interim measure while engineering controls and work practices are being implemented, is supported by evidence from the record and is consistent with the policy approach taken in all prior air contaminant standards promulgated by OSHA. Almost all representatives of the lead industries, including LIA and BCI, concurred with this approach provided engineering and work practice controls were feasible. (Ex. 342, p. 6; Ex. 355; Ex. 341, p. 12). The rationale behind this approach is based primarily on two principles. One is that protection of the employee is most effectively attained by elimination or minimization of the hazard at its source, which work practices and engineering controls are both designed to do, and the other is the methods which depend upon the vagaries of human behavior are inherently less reliable than well-maintained mechanical methods. The validity of these generalizations has been borne out by agency experience obtained throughout OSHA's existence and has been reiterated by many professional industrial hygienists for the lead record (Tr. 2068.) Engineering control is unquestionably the best method for effective and reliable control of employee exposure to lead. (Tr. 1366; Ex. 270, p. 20.) It acts on the source of the emission and eliminates or reduces employee exposure without reliance on the employee to take self-protective action. This method encompasses product substitution, process or equipment redesign, process or equipment enclosure, exhaust or dilution ventilation, and employee isolation (e.g., a standby pulpit, but not personal protective equipment). Once it is implemented, it protects the employee permanently, subject only, in some cases, to periodic preventive maintenance. Work practices also act on the source of the emission, but rely upon employee behavior, which in turn relies upon supervision, motivation, and education to make them effective. For this reason, work practices are not as desirable a method as engineering controls, but because the two methods often must be employed together to make either one effective (Ex. 270, pp. 22-23; Tr. 2069) and because they are the only methods that act to eliminate or reduce the hazard at its source, they have been given equal status in the compliance priorities of the final lead standard.
Administrative control, as a type of work practice, is also included in the group of primary methods of exposure control that must be used before respiratory protection. This modifies the approach in the proposed standard in which engineering controls were to be given priority over work practices, and reference to administrative controls was omitted. The approach in the final standard is primarily a result of recognizing the important role of work practices and clarifying the definition of the term "work practices" to include "administrative controls." These terms have been somewhat ambiguous in that the term "work practices"has been commonly thought to include employee rotation or other administrative types of control. However, OSHA's policy has generally been to denigrate the use of administrative controls (while still approving of other work practices) because they not only fail to eliminate the hazard but they expose more workers to the contaminant, albeit for shorter periods of time. The latter reason makes administrative controls unacceptable when the contaminant is one for which no effect levels are unknown, e.g., carcinogens. (See preamble to standard for occupational exposure to inorganic arsenic, 43 FR 19617, May 5, 1978.). In the case of lead, however, the PEL is based on dose-response data and although administrative controls do not eliminate or reduce the hazard as engineering controls and other work practices do, they can be a relatively safe and effective means of maintaining TWA levels below permissible limits.
Respiratory protection is relegated to the bottom of the compliance priority list because it is an ineffective, unreliable, and unsafe method of reducing employee exposure. The Council on Wage and Price Stability (Ex. 224) and some industry representatives (e.g., Ex. 3(107)) suggested a control strategy which would permit employers to place principal reliance on respiratory protection where employers determined that it was a "less costly method of achieving the same level of worker health." (Ex. 224, p. 14.) It is true that respirators are usually less costly than engineering controls, hence CWPS's and employers' eagerness to prefer them as the solution to control problems, but it is also true that respirators are not comparable alternatives to engineering controls, work practices, and administrative controls because they do not eliminate the source of the exposure, are generally not capable of providing the protection required, and create additional hazards by interfering with vision, hearing, and mobility. (Tr. 1967; 1462.) Some employees develop skin rashes where the facepiece makes contact with the skin, and some employees with cardiopulmonary impairment, otherwise able to work, cannot safely work with a respirator placing stress on their breathing. It may be difficult to fit female employees or employees with unusual facial configurations since respirators are manufactured with males as standards. (Tr. 1360.) The OSH Act places the primary burden of compliance on the employer, and to shift it to the employee, as respirators do, is, according to NIOSH, inappropriate (Tr. 1462) and is contrary to established OSHA policy. (See preamble to cotton dust standard, 43 FR 27384 (June 23, 1978).) Respirators do, however, serve a useful function where engineering and work practice controls are inadequate by providing supplementary, interim, or short-term protection, provided they are properly selected for the environment in which the employee will be working, properly fitted to the employee, maintained and cleaned periodically, and worn by the employee when required.
It is clear from the discussion on feasibility (attachment D) that compliance with the PEL solely by means of engineering controls and work practices is feasible in all the affected industries, although in certain ones major process and control modifications may be required. The steelworkers noted that "the question of feasibility is basically one of length of time necessary for any plant to achieve compliance. . . ." (Tr. 4634.) Dr. First also agreed that "stringent limits for lead exposure should be treated as goals to be reached over reasonable time periods." (Ex. 270, p. 19.) The Court of Appeals for the Third Circuit in its review of the asbestos standard also recognized the need to allow "sufficient time to permit an orderly industry-wide transition. . . ." IUD v Hodgson, 499 F. 2d 467, 479 (3d Cir 1974).
The time necessary to implement these modifications will vary from industry to industry according to the magnitude of the modification required, but essentially it is based on the time necessary to plan, design, acquire, install, and test them. OSHA has taken these factors into account by developing an implementation schedule for compliance solely by the use of engineering controls and work practices. This schedule represents OSHA's best estimate of when each industry as a whole can feasibly come into compliance. This approach was what the third circuit apparently expected when it remanded the asbestos standard for clarification of why inter-industry distinctions were not recognized in establishing the effective date for the two fiber PEL. (499 F. 2d at 479-81.) The rationale for the times chosen for each industry is contained in the discussion of feasibility in attachment D.
The language of paragraph (e)(1) is intended to impose on the employer the affirmative obligation to comply with the implementation schedule solely by means of engineering and work practice controls. This obligation has been determined to be feasible (see attachment D) and thus the obligation in the proposal to implement only "feasible" controls has been deleted in the final standard. OSHA's intent is to preclude individual employers from raising and proving the defense of infeasibility of compliance in an enforcement action and having citations vacated. OSHA has established industry wide feasibility and does not believe that any individual employer should be able to escape obligations that the industry as a whole can meet. On the other hand, OSHA will take individual claims of infeasibility into account through abatement programs tailored to meet the needs of individual firms and their employees. In addition, where an employer needs more time to comply with the implementation schedule and a temporary variance under section 6(b)(6)(A) of the Act is appropriate, it should be sought. Similarly, the mandatory nature of these requirements is not intended to discourage or inhibit the development of different, equally effective means of providing the required protection. The variance provisions of section 6(d) of the Act, and the implementing regulations in Part 1905 of this title, provide a mechanism for employers to obtain variances from the provisions of this section where the employer has developed alternative procedures which are as "safe and healthful as" those required by this section. The variance provisions of the Act permit the flexibility which contributes to efficient compliance with the standard. OSHA encourages interested employers to utilize the variance provisions of the Act where equally safe and healthful protective means are available.
Additionally, since the standard has been deemed to be feasible in all industry segments, the standard establishes an employer's failure to meet the exposure levels in accordance with he implementation schedule as a prima facie violation of paragraph (e)(1). However, the preamble recognizes that engineering and work practice controls may not be adequate or appropriate at certain times (e.g., unexpected process upsets) or for some job task which are performed in locations which are not predeterminable (e.g., repair, non-routine maintenance) or inaccessible (e.g., lead burning in ship hulls). In these and other cases, it should properly be the employer's burden to prove impossibility or technological infeasibility of compliance. The employer is familiar with his workplace and the production processes and control technology available to his industry and should properly bear the responsibility of proving an inability to comply.
The standard also has a requirement for the development and implementation of a written compliance plan where the employer has employees exposed to lead, without respect to respiratory protection, in excess of the PEL. The plan should be a written strategy for achieving compliance with the implementation schedule solely through the use of engineering and work practice controls, and must incorporate all relevant information that relates to those goals so that in an examination of the plan, one could determine whether the employer reasonably analyzed the problems and their solutions, including alternatives and implemented the plan in accordance with its schedules.
This plan is required primarily to promote systematic and rational compliance by employers and to assist OSHA in its enforcement function by enabling compliance personnel to monitor employers' compliance activities.
The standard requires the employer to have the written plan completed and made available at the worksite according to a schedule determined by the compliance implementation schedule in Table I of paragraph (e)(1). OSHA considers 6 months to be a sufficient planning period when the total compliance time is 1 year and the compliance effort is not complex. For those industries where compliance will require between 2 and 5 years, 1 year for planning and preparation of the plan is deemed adequate; for the primary lead production industry which has 10 years to comply with the PEL, as much as 5 years may be needed so as to incorporate the latest developments in emerging technology.
Upon examining the employer's compliance plan, the Secretary will determine whether the plan's schedule for implementation of engineering and work practice controls is designed to and will achieve compliance with the PEL by the required date. OSHA will take enforcement action in cases where the compliance program does not project the implementation of these controls by that date, or where it appears that the schedule for implementation is extended such as to render completion by the required date unlikely. In addition the employer who has developed an adequate plan for reducing employee exposure below the PEL but does not meet the scheduled implementation dates in the plan will be subject to citation.
These written plans must be furnished upon request for examination and copying to representatives of the Assistant Secretary and the Director and to affected employees and their designated representatives. They must be reviewed and updated periodically at least every 6 months to reflect the current status of exposure control. OSHA views the requirement for written plans as an essential part of the compliance program since it will form the basis for determining the employer's ability to achieve the controls and provide the necessary documentation to OSHA of the compliance methods chosen, the extent to which controls have been instituted, and of the plans to institute further controls.
The inclusion of the 200 ug/m(3) level in the schedule is simply intended to continue the present standard, which has been in effect since 1971. This level will continue to be enforced until compliance with a lower level is required. For the five named industries compliance with 100 ug/m(3) by engineering and work practice controls will be enforced at the times indicated as an interim milestone until ultimate compliance with the PEL is achieved. The time allowed for each industry to comply is based on record evidence of the nature of the action required in each industry and the time reasonably necessary to accomplish it. Since ultimate compliance in several industries will take as much as five or more years, compliance with 100 ug/m(3) as an intermediate milestone is required because it will assure a greater measure of employee protection than might otherwise be provided if no intermediate goal were specified. OSHA recognizes that in some limited cases ultimate compliance with the PEL may require action that is inconsistent with action that would be required to reduce levels to the 100 ug/m(3) interim level. This is meant to cover the situation where the allocation of technical or economic resources to compliance with the interim level would divert resources from the final goal and clearly preclude compliance with the PEL, which would otherwise be attainable, by the required time. An example of where this situation may arise is where compliance with the interim level could be achieved by retrofitting an antiquated production process with expensive dust control devices, but only removal of those devices and costly redesign and modernization of the process could achieve compliance with the PEL. If the employer's compliance program contemplates achieving the PEL within the schedule, and the employer can demonstrate why compliance with the interim level is incompatible with compliance with the PEL, the employer must conform the compliance plan accordingly and notify the OSHA Area Director nearest the workplace. This notification requirement is intended to alert OSHA that an employer intends to bypass the interim level and to initiate an inspection of the compliance plan if appropriate.
The final standard retains the requirement that where mechanical ventilation is used, quarterly measurements of the system's effectiveness must be made. Some parties claimed that this was too costly, but OSHA believes that periodic checks are absolutely necessary to insure the integrity of a ventilation system. It should be noted that the three measurements listed in the regulation are only examples. Any measurement which assures the system's effectiveness will comply with the standard. In addition, because of the cost and minimal utility, the requirement that a record of these measurements be kept has been deleted.
The proposed standard prohibited the recirculation of workspace air. However, as Dr. First explained during the hearings, "energy conservation by recirculation of industrial exhaust ventilation air is a highly desirable goal" if "a system of that type would be sufficiently reliable given the general degree of maintenance and repair of air control equipment that we see in industry." (Tr. 2320; Tr. 5310) The weight of the evidence from the hearing is that safe recirculation is technologically feasible and economically desirable for dry particulate dusts. The post-hearing brief of the Steelworkers concluded from the hearings that "it is now possible for plants to operate recirculation systems safely with the advent of sophisticated back up equipment." (Ex. 343, p. 126) The Battery Council International agreed. (Ex. 342, p. 7) The LIA suggested that "since the outdoor ambient air in the vicinity of a lead plant often contains a relatively high air-lead concentration, properly designed recirculation systems may furnish the workplace with air that is in fact lower in lead concentration than the air which would otherwise be drawn in through conventional air systems." (Ex. 335) Similarly, Caplan of IHE stated that "a well-designed recirculation system could provide a healthier working environment than would a conventional exhaust and make-up air system . . . If you would permit recirculation, again and always with adequate safeguards, then the designer and the owner and operator can afford to be more generous with the amount of air handled in the exhaust hoods and dust control hoods, and therefore achieve better results." (Tr. 3719) In its report for the BCI, IHE described a safe design for recirculation. (Ex. 29(29A), pp. 6-7) The system would consist of a self-cleaning fabric filter as the first air cleaning devices followed by a second or high-efficiency backup filter of the HEPA type. This second filter can be tested in place to assure its proper functioning, and there are no moving parts to reduce the efficiency of such a filter bank. Other controls can easily be installed to monitor the concentration of lead oxide dust in the air, and to bypass the recirculation systems automatically if it fails. Schneider also described a safeguard system used in the beryllium industry. (Tr. 2075-76) Based on the availability of these designs, OSHA believes that safe recirculation of air is technologically feasible and can be sufficiently protective. Recirculation is also fuel efficient and economically desirable because tempering of additional make-up air would not be required and additional air quality systems may not be necessary. (Ex. 342, p. 7) IHE performed cost calculations with and without recirculation in its cost study of 12 battery plants to illustrate the fuel savings. (Ex. 29(29A).) Caplan testified that the capital cost of installing a safe recirculation system can be recovered in one year by the savings in fuel. (Tr. 3718-19) OSHA thus has permitted recirculation of air under conditions which will provide cost savings to employers and fuel efficiency with adequate protection of employee health.
Finally, the fiscal standard requires that when administrative controls are used to lower employee exposure, a rotation schedule is to be kept and followed and made a part of the written compliance plan. This will enable OSHA and affected employees to determine the effectiveness of the administrative control program.
F. RESPIRATORY PROTECTION: PARAGRAPH (f)
This section contains specific requirements for the usage, selection, maintenance, and fitting of respirators. It is, in essence, unchanged from the proposal except certain provisions have been added to account for the possibility that substantial reliance may be placed on respirators to achieve permissible limits while engineering and work practice controls are being implemented. As a general matter, few objections to the proposed respirator provision were made; specific ones are discussed below.
The final standard, like the proposal, requires that respirators be used during the time period necessary to install or implement engineering and work practice controls, when engineering and work practice controls are not sufficient to reduce exposure to the permissible exposure limit, or whenever an employee requests a respirator. This last requirement is to provide protection for those employees who wish to reduce their lead burden below that which is required by the standard. For example, male and female workers whose blood lead levels are in the 30-50 ug/100g range may desire increased protection, especially if they intend to parent in the near future.
While respirators are the least satisfactory means of exposure control, they are capable of providing protection if properly selected, fitted, maintained, replaced when they cease to provide adequate protection, and worn when required. While it is theoretically possible for all of these conditions to be met, it is often the cast that they are not, and as a consequence, the protection of employees by respirators is not considered effective. Further, employees with impaired respiratory function may not be able to wear certain types of respirators, such as those operating in the negative pressure mode.
Several witnesses addressed the difficulty in obtaining a proper fit in some employees. Robert Schutz, of NIOSH's Testing and Certification Branch, noted that respirators have traditionally been designed to fit men and only recently has NIOSH proposed regulations to amend Subpart K of Part 11, 30 CFR, for dust, fume and mist respirators, to include a test panel composed of women test subjects. (Tr. 1360) Edward Baier, Deputy Director of NIOSH, further emphasized that while respirators are not suited to woman's faces, they are also not suitable for persons wearing a beard or mustache or even persons with a scar. (Tr. 1459). Many other participants elaborated on other problems associated with respirator fit. (Ex. 91, Tr. 1240-1; Tr. 6433; Tr. 6476; Ex. 155A).
There are more problems associated with respirator use than those of fit. Fatigue and reduced efficiency occur more rapidly among workers wearing respirators due to increased breathing resistance, hearing stress and reduced vision. (Ex. 91; Tr. 6476) Safety problems presented by respirators must be considered. (Ex. 91) Respirators may limit vision, which is a significant factor where numerous physical hazards exist and the employee's ability to see is important. Speech is also milited. (Ex. 91) Voice transmission through a respirator can be difficult, annoying and fatiguing. (Tr. 5871, 6616) Communication may make the difference between a safe, efficient operation and a hazardous operation, especially in dangerous jobs. Entanglement of hoses of air respirators as well as limited mobility due to hose lengths, are problems in heavy industrial environments. (Ex. 91, Tr. 4014) Self-contained breathing apparatus have the double problem of restriction of motion and necessity for carrying around heavy weight. (Ex. 91) Despite the inherent difficulties associated with respirator use, they remain the only viable form of protection when engineering and work practice controls are not adequate to achieve permissible limits. Witnesses for NIOSH, labor and industry agreed that respirators are only acceptable as an interim measure (Tr. 1459; Tr. 2494-95; Tr. 6455; Tr. 6476; Tr. 1313; Tr. 1561; Tr. 1240-41; Tr. 1966; Tr. 5812; Tr. 5821; Tr. 5508), and OSHA emphatically agrees that respirators are not to be used as a primary method of control. However, because of the lengthy compliance periods required by some industries to implement engineering controls and work practices, respirators will be necessary in the interim as the only available protective method.
A daily limit on duration of respirator usage (e.g., Tr. 1459; Tr. 5801-11; Ex. 343, p. 118) has been considered by OSHA, especially for those industry segments which presently have high lead exposure and will require a year or more to reduce levels to permissible limits. In most cases respirators will not be required to be worn for a full day; the respirator will only be required to be worn for a period of time which, when averaged with the period the respirator is not worn, does not exceed the PEL. For example, if environmental monitoring shows that an employee's exposure level without regard to a respirator is 100 ug/m(3), the respirator need be worn only a little more than 4 hours. (See paragraph (c)(3) of the regulation and discussion in paragraph C of the Summary and Explanation.) The evidence in the record on the inadequacy, discomfort, and hazards associated with respirator usage support some limitation of full-shift wearing of respirators for long periods of time. (Ex. 155, p. 9) Four industries (secondary lead production, battery manufacturing, pigment manufacturing, and nonferrous foundries) are not required to meet the PEL for five years; one industry (primary lead production) is not required to meet it for 10 years. OSHA has concluded that for these industries the time for compliance with the interim level of 100 ug/m(3) should begin a limitation for respirator usage for employees. Accordingly, the final standard limits to 4.4 hours the amount of time an employee may be required to wear a respirator after 3 years in primary smelting, secondary smelting, and pigment manufacturing; after 2 years in battery manufacturing and after 1 year in nonferrous foundries. The time limit is based on the maximum amount of time an employee would have to wear a respirator (assuming a protection factor of 10) if the employer has complied with the interim level, and as such, imposes no additional burden on the employer. If the interim level of 100 ug/m(3) is not achieved within the compliance dates specified, the employee will not be required to wear respirators more than 4.4 hours per day, and the employer will be required to use other means, for example, worker rotation, to achieve compliance with the PEL of 50 ug/m(3). OSHA anticipates that some firms will not attempt to achieve the interim 100 ug/m(3) PEL but will develop a compliance plan which by-passes the interim level. OSHA believes this is an acceptable method of compliance, but the agency does not believe the employee should be required to bear the burden of the continued high lead levels by being required to wear respirators 8 hours per day. OSHA has attempted to provide a great deal of flexibility in the methods of compliance in order to reduce the burden to the employer without compromising the health of the employee. The employees cannot be expected to accept these more flexible compliance provisions if they are to bear the brunt of the effects of that flexibility by being required to wear respirators continuously. Worker antipathy toward respirators is well documented in the rulemaking records of this and other OSHA standards and in addition the agency is concerned that respirator use for 8 hours over an extended period of time may constitute a health risk to individual employees, especially those with cardio-respiratory disorders.
Because of the discomfort and hazards associated with negative pressure respirators, coupled with the possibility of long-term use in some industries, OSHA has required employers to provide powered, air purifying (positive pressure) respirators (PAPR) to employees who request one, so long as it will provide adequate protection against the hazard for which a respirator is worn. Powered positive-pressure respirators provide greater protection to individuals (Tr. 1556), especially those who cannot obtain a good face fit on a negative pressure respirator (Ex. 155, p. 8), and will provide greater comfort when a respirator needs to be worn for long periods of time. OSHA believes employees will have a greater incentive to wear respirators if discomfort is minimized.
The standard requires the employer to select respirators in accordance with Table II from those approved by MSHA or NIOSH. The respirator selection table will enable the employer to provide the type of respirator which affords the proper degree of protection based on the airborne concentration of lead. While the employer must select the appropriate respirator from the table on the basis of the airborne concentration of lead, he may always select a respirator providing greater protection, that is, one prescribed for higher concentration of lead than present in his workplace. The respirator table is based on the NIOSH recommendation presented during the March 1977 hearing. (Ex. 86I, 86J, 87, 88, 89, 90, 91) Similar to the proposal, single use respirators are not permitted to be used by the final standard. The 3M Company criticized the exclusion of the single use respirator from the respiratory selection table. (Ex. 3(36)) The original exclusion of single use respirators was based primarily on the inadequate protection factor, the fact that lead is a systemic poison, and the current provisions of 30 CFR Part 11 for approving single use respirators.
OSHA is particularly concerned about the penetrability of the single use respirator in a lead environment, which raises doubts about the protection factor of 5. OSHA will request that NIOSH study the efficacy of single use respirators in the future and make their findings known to the Agency. OSHA has reviewed the basis of its original decision concerning the protection afforded by a single use respirator and accepts the respirator decision logic in eliminating single use respirators for use with systemic poisons.
The standard further requires that the employer institute a respiratory protection program in accordance with 29 CFR 1910.134. This section contains basic requirements for proper selection, use, cleaning and maintenance of respirators.
The standard also requires that respirators be properly cleaned and filters replaced when necessary. (Tr. 5565, Ex. 91, Chapters 8 and 9) The employer is also required to assure that the respirator facepieces fit. Proper fit of the respirator is critical. (Ex. 91; Tr. 1828, 4724) As a negative pressure is created within the facepiece when the wearer breathes, unfiltered air may enter the facepiece if gaps exist. (Ex. 91) Obtaining a proper fit on each employee may require the employer to provide two or three different mask styles.
In order to insure that the employee's respirator fits properly and that facepiece leakage is minimized, there was agreement by industry, government and labor that fit testing should be done. (Tr. 1554, 1556, 1966, 2311, 3203-04, 4721, 4935, 6480, 2401, 2311; Ex. 91) A quantitative fit test on negative pressure respirators is required by the standard because it is more accurate and provides greater assurance that the respirator is providing proper protection to the employee than any other type of fit testing. (Tr. 3203-4; 1554-56; 2311; 4721; 1966) Whereas the qualitative fit test is subjective, relying upon the employee's sense of smell, the quantitative fit test uses instrumentation inside the facepiece to determine the integrity of the seal. One type of quantitative fit test involves using a simple hood, sodium chloride vapor, and automated instrumentation. It can be performed rapidly and easily. The cost of the quantitative fit testing equipment is substantial, but since the standard only requires it to be done twice a year and since some employees will be wearing respirators for extended periods of time, OSHA has concluded that good respirator fit must be assured and that the benefit of quantitative fit testing far outweighs the costs involved. NIOSH confirmed the feasibility of such testing (Tr. 1556), and the costs for small employers can be minimized because the testing equipment is mobile and could be brought to the workplace on a fee basis. (Tr. 1555; 4722) In addition, the standard requires that employees be properly trained in the use of respirators. (Ex. 91) The employee must be properly trained to wear the respirator, to know why the respirator is needed and to understand the limitations of the respirator. (Tr. 4010, 4011, 4085; Ex. 91) An understanding of the hazard involved is necessary to enable the employee to take steps for his or her own protection. The respirator protection program implemented by the employer must conform to the program set forth in 29 CFR 1910.134.
The standard requires that the employer shall provide respirators at no cost to the employee. This has been added to make explicit what was implicit before and has been common practice in all industries. Allocation of respirator costs to the employer was made in the EIS (Ex. 26).
G. PROTECTIVE CLOTHING AND EQUIPMENT: PARAGRAPH (g)
This paragraph contains requirements that the employer provide employees with protective clothing and equipment that are appropriate for the hazard. The purposes are to protect employees from lead compounds which may cause skin or eye irritation (e.g., lead arsenate, lead azide) and, for employees who are exposed to lead above the PEL to assure that clothing, shoes, and equipment on which lead dust can accumulate during the work shift are not worn home or in the lunchroom. Wearing contaminated clothing outside the work area where exposure controls are operating will lengthen the duration of exposure through both inhalation and ingestion routes. In addition, lead dust will accumulate in employees' cars and homes exposing other family members to the hazard. (Tr. 4146) These provisions generally met with approval by all participants to the rulemaking, and, in fact, most employers presently provide clothing and equipment at no cost to employees. (Ex. 26, pp. 5-11, 5-35, 5-68; Tr. 2215, 3788, 4078, 4147, 5055, 5263, 5554, 5656, 6156, 6256, 6257, 6287, 6300, 6310, 6393).
The proposal did not specify the frequency with which work clothing must be provided. OSHA has determined that if clean work clothing is provided at least weekly to employees whose exposure levels are above the PEL and daily for those above 200 ug/m(3), adequate protection will be afforded and unnecessary costs minimized.
The final standard also emphasizes the need to assure that contaminated clothing is stored, cleaned, or disposed of in a safe manner. It requires that contaminated clothing be stored in sealed containers prior to laundering or disposal so that contamination in the change room is minimized and that employees who later handle the clothing are protected. The latter group are further protected by the requirements to put warning labels on the containers and to provide written warning of the hazards of lead. These practices commonly occur in the lead industries today and thus do not impose significantly new obligations on employers. (Tr. 1253, 1656) Some confusion arose over the language in the proposal that "the employer shall launder, maintain, and dispose of all protective clothing." (Paragraph (h)(2)) This was interpreted by some employers as requiring the employer to operate his own laundry facilities. This was not OSHA's intent, and the final standard attempts to make clear that the employer may utilize commercial laundries by stating that the "employer shall provide for the cleaning, laundering, or disposal * * *" Some witnesses testified that discarded and dirty uniforms should never leave the plant (e.g., Dr. Teitlebaum, Tr. 530), but OSHA believes that the labeling and warning requirements of the standard will minimize exposure outside the plant.
H. HOUSEKEEPING: PARAGRAPH (h)
The final standard requires that all surfaces be maintained as free as practicable of accumulation of lead dust. This is to be accomplished primarily by vacuuming of floors, rafters, and other surfaces or by methods equally effective in preventing the dispersal of lead into the workplace. This is an exceptionally important provision because it minimizes additional sources of exposure that engineering controls are generally not designed to control. All participants to the rulemaking agreed to the need for scrupulous housekeeping. (Ex. 335, p. A-9; Ex. 270) Donald Hull, president of a small battery manufacturing company, testified that he attributed the success of his industrial hygiene program to a primary emphasis on housekeeping. (Tr. 1246) The proposed language for this provision required "surfaces to be maintained free of accumulation of lead which, if dispersed, would result in airborne concentrations above the permissible exposure limit." (Paragraph (i)(7)) This requirement would be very difficult for the employer to comply with and OSHA to enforce because it would be nearly impossible to objectively determine when the condition in the standard would occur. (Ex. 3(71), p. 13) OSHA's view is that a rigorous housekeeping program is absolutely necessary to keep airborne lead levels below permissible limits but that the obligation should be measured by a standard of practicability. (Tr. 5747) This contemplates a regular housekeeping schedule based on exposure conditions at a particular plant and the capability for emergency cleanup of spills or other unexpected sources of exposure.
Vacuuming is considered by all experts to be the most reliable method of cleaning surfaces on which dust accumulates (Tr. 2379; 2069) but equally effective methods may be used, for example, a wet floor scrubber. (Tr. 2922) Dry or wet sweeping, shoveling, or blowing with compressed air may not be used except where vacuuming or other equally effective methods have been tried and do not work. (Tr. 2196-99; 2379)
I. HYGIENE FACILITIES: PARAGRAPH (i)
This provision requires employers to provide hygiene facilities and to assure employee compliance with basic hygiene practices which are recognized industrial hygiene tools for minimizing additional sources of lead absorption for inhalation or ingestion of lead that accumulates on a worker's clothes or body. No later than one year for the effective date of the standard, the employer must provide adequate shower and washing facilities, clean rooms for changing clothes, and filtered air lunchrooms for employees who have exposure above the PEL. In addition, employers must assure that employees use the facilities as required by the standard as well as observe prohibitions on tobacco, food, and cosmetics in contaminated areas. OSHA expects that strict compliance with these provisions will virtually eliminate several sources of lead exposure which substantially contribute to increases lead absorption.
Several of these facilities and practices are presently required under current OSHA standards for General Environmental Controls in Subpart J of 29 CFR Part 1910. For example, 1910.141(e) requires the employer to provide change rooms with separate storage facilities for street and work clothing, and section 1910.141(g) requires the employer to prohibit the consumption of food and beverages in areas where there is exposure to toxic substances. The provisions of this standard are intended to augment Subpart J with additional requirements which are specifically applicable to lead exposure and to consolidate all related provisions under one standard.
Many firms affected by this standard have already instituted facilities similar to those required in the final standard. (Tr. 1231; 2176; 2905; 2943; 3655; 3785; 4395; 4397; 4844; 4875; 5651; 5655; 6154; 6209; 6270) Employee usage of these facilities has been limited in some cases because, absent mandatory obligations, employers have not been successful in encouraging such usage. (Tr. 2567, 4875, 6318, 6453-54) The standard does not impose mandatory obligations on employees, as some employers have suggested, because employers are in a better position to impose and enforce work rules or practices. OSHA does however believe that employees have a responsibility to act consistent with the objectives of the standard and to comply with all reasonable work rules designed to implement them.
Employers generally conceded the authority to impose and enforce reasonable work rules or make compliance with them a condition of employment. (Tr. 2070; 2943) Labor union officials have offered to assist industry in enforcing equitable hygiene practices. (Tr. 1038, 2943, 2969) OSHA's experience has been that if employees understand the need for these provisions and if the hygiene rules are imposed in a fair and equitable manner, employers will experience a minimal lack of cooperation from employees.
The final standard requires employers to prohibit smoking, eating applying cosmetics and the presence of tobacco products, food stuffs, or cosmetics in all work areas except those designated. (Tr. 6459) This prohibition will prevent unnecessary contamination of food or tobacco products caused by exposure to lead dust or fumes within the work area. It also decreases the likelihood of lead absorption in employees due to ingestion or inhalation of products contaminated with lead within the work environment.
The standard reiterates specifications in section 1910.141 pertaining to the type of change room an employer must provide. OSHA believes it is essential that employees have separate storage areas for street and work clothing to prevent cross-contamination between the two. This provision coupled with showering and the prohibition on wearing work clothing home will minimize employee exposure to lead after the work shift ends because it reduces the period in which work clothes coated with lead dust may be worn.
Employers are also required to assure that employees exposed to lead during their work shift shower before leaving the plant and do not leave wearing work clothing. Showering reduces the worker's period of exposure to lead and removes lead particles which accumulate on the skin and hair. Employees are not permitted to leave the plant wearing any work clothes, including shoes and underwear, because this practice would negate any advantage gained by showering.
During the hearings, some employers protested that this provision is impractical because it would require close supervision of employees, but none challenged the provision as unnecessary. In fact, many industries maintain shower facilities and advise their employees to shower at the end of their shift. Some companies require that workers shower. (Tr. 5658, 6259) OSHA believes showering is a necessary practice providing protection to employees and their families which far outweighs the limited burden placed on employers.
The final standard requires employers to provide persons working in lead areas with filtered air lunchrooms which are readily accessible. Employers must also assure that employees wash their hands and face prior to eating or smoking and do not enter the lunchroom wearing protective clothing, unless cleaned beforehand. OSHA feels it is imperative that employees have a clean place to eat, free from the toxic substance with which they work all day. Filtered air lunchrooms will shield employees from the dangers of food which would otherwise become contaminated by lead dust, mist or fume. (Tr. 2074) Employees are required to wash before eating to further minimize the possibility of food contamination and reduce the likelihood of additional lead absorption from contaminated food, beverages or tobacco. To further insure minimal food contamination, protective clothing must either be removed or cleaned before entering the lunchroom (Tr. 2074). Instead of requiring any particular method, employers are given discretion to choose any method for removing surface lead dust which does not disperse the dust into the air.
The hygiene provisions in the final standard are necessary and appropriate to protect employees within affected industries from unwarranted and dangerous exposure to lead not necessary to job performance. Few, if any, participants in the rulemaking denied the benefits afforded by these provisions.
J. MEDICAL SURVEILLANCE: PARAGRAPH (J)
The medical surveillance program is part of this standard's comprehensive approach to prevention of lead-related disease. Its purpose is to supplement the standard's primary mechanisms of disease prevention, the elimination or reduction of airborne concentrations of lead and sources of ingestion, by facilitating the early detection of medical effects associated with exposure to lead. Control of airborne lead below the permissible exposure limit will protect most workers from the adverse effects of lead exposure, but may not be satisfactory to protect individual workers (1) who have high body burdens of lead acquired over many years working in the lead industries, (2) who have additional, uncontrolled sources of lead exposure (e.g., non-occupational), (3) who exhibit abnormal variation in lead absorption rates, or (4) who have specific medical conditions which could be aggravated by lead exposure (e.g., renal disease, anemia). In addition, control systems may fail or hygiene and respirator programs may be inadequate, and periodic medical surveillance of individual workers may help detect those failures.
The proposed standard contained provisions for a medical surveillance program which combined periodic biological monitoring with preplacement and followup medical examinations. In general, the proposal met with approval from all interested parties although there was disagreement on specific issues such as the content of the medical exam and the frequency of biological monitoring. OSHA has reviewed all the rulemaking evidence on this subject and has concluded that the final standard, while similar to the proposal, contains a medical program that is reasonably necessary and appropriate for the early detection of the effects associated with overexposure to lead. OSHA has detected the unnecessary or objectionable aspects of the proposal and supplemented it with only those medical tests and procedures which the lead record documents are necessary to identify early indications of lead-related disease in the affected systems. The final standard also contains provisions which will maximize voluntary and willing participation and will foster employee confidence in the program, both of which are often lacking in current industrial medical programs (Ex. 343).
The employer's obligation to commerce a medical surveillance program for an employee is triggered by a determination that the employee's exposure exceeds the action level for more than 30 days a year. Some firms in the primary smelting industry claimed that all employees working with lead should be subject to periodic medical surveillance without regard to air lead levels. (Ex. 3(67); Ex. 3(103), p. 59; Ex. 3(71), p. 15.) This may be desirable for lead industries where lead exposure is so pervasive, but the OSHA standard applies to many industries in which lead exposure is relatively low, infrequent, or incidental. OSHA believes there is no need or justification for employees whose TWA exposure levels are below the action level, or above the action level for less than 30 days a year, to undergo medical surveillance or for their employers to bear the related costs.
Upon completion of initial air monitoring, the employer must begin the medical surveillance program for all covered employees. The standard does not make participation in the medical surveillance program mandatory for the employee. The employer's obligation is to "provide" and "make available" the medical tests and procedures as required. Where employee confidence in the medical program exists, refusal to participate should be minimal. (See discussion of mandatory medical examinations in the MRP Attachment.) Initial biological monitoring and medical examinations must be completed no later than 180 days from the effective date thus allowing 90 days form the completion of air monitoring. (See paragraph (r) of the regulation.) In most cases, this extended startup date should compensate for the predicted short-run unavailability of medical and technical personnel, and OSHA believes the problems will be minimal since some type of medical surveillance program is commonplace in most industries where lead is handled, even in the smallest firms.
The standard requires that priority for medical surveillance be given to employees who are at the greatest risk from continued exposure. This determination should be made on the basis of the air monitoring results, along with any other information the employer may possess, such as past medical or air monitoring records, employees' job tenure in the lead industries, etc. This should assure that those employees most in need of medical surveillance obtain it as soon as possible so that remedial action may be taken if necessary.
Biological monitoring required by the final standard is somewhat different than that in the proposal. The proposal would have combined blood lead level monitoring (PbB) which monitoring of urine lead levels (PbU) or urine ALA levels (ALAU); urine measurements have been deleted and replaced by monitoring of zinc protoporphyrin (ZPP) levels. The preamble to the proposal expressed the medical community's doubt about the usefulness of urine monitoring; with a few exceptions (Tr. 4358), the consensus in the record was in favor of deleting urine measurements, and adding ZPP monitoring. (Tr. 1309, 1311-12, 2656, 2732, 2771, 2877, 4358, 4735.) PbB's have been the traditional means of biological monitoring in the lead industries. It is a relatively accurate measurement of current lead absorption, and almost all dose-response studies of lead-related disease have used PbB's as an index of exposure dosage. (Tr. 1311.) Hence, OSHA has had to rely on PbB's to establish the PEL and now retains PbB's as an essential part of the biological monitoring program. (Ex. 284A, p. G1.) However, the advent of simplified ZPP monitoring through the use of the hematofluorometer has convinced OSHA that ZPP monitoring, in concert with PbB's, will provide, at minimal cost, a greatly improved biological monitoring program over PbB's alone. PbB measures only absorption of lead; ZPP gives an indication of the biological effect of absorption on heme synthesis.
Heme is the basic component of both hemoglobin, which functions in the transport of oxygen from the lungs to the body cells, and the cytochromes, which function in the respiration of the individual cells. Therefore, any interference which heme synthesis may create a considerable adverse effect on the body. (Tr. 429.) Lead is one substance known to produce such interference, causing changes, not only in heme production, but also in the level of some of the circulation intermediate metabolites formed during heme synthesis. These metabolites include delta-amino-levulinic acid dehydratase (ALAD), delta-aminolevulinic acid (ALA), coproporphyrin, and zinc protoporphyrin (ZPP). (Ex. 275.) Zinc protoporphyrin is actually the result of the inhibition of an enzyme, ferrochelatase, which catalyzes the insertion of an iron molecule into the protoporphyrin molecule, which then becomes heme. If iron is not inserted into the molecule, then zinc, having a great affinity for protoporphyrin, takes the place of the iron, thus forming ZZP. (Tr. 435.) Whereas the heme molecule serves in a very necessary body function, ZPP is useless to the body, but it is the most easily measured heme metabolite. (Tr. 436; Ex. 343.) Measuring the level of ZPP in the blood is one means of determining the internal toxic effect of lead absorption, relative to heme synthesis impairment. In fact, the level of ZPP is a far superior indicator of lead toxicity than the level of blood lead itself, which actually only measures the level of individual exposure. (Ex. 343) Furthermore, an elevation in the level of circulating ZPP may occur at a very low blood lead, i.e., 20-30 ug/100 g in some workers. (Ex. 262.) Once the blood lead level has reached 40 ug/100 g, however, there is a precipitous rise in the ZPP value from its normal range of less than 100 ug/100 g whole blood. (Ex. 105E) As the evidence within the record indicates, there is a strong correlation between elevations in these two biological parameters, blood lead and ZPP. In fact, it has been shown that after the blood lead level reaches 40 ug/100 g, any arithmetical increase in blood lead will correspond to an exponential increase in ZPP. (Ex. 105E; Ex. 23(39); Tr. 439.) It is possible that the ZPP test is one of the earliest and most reliable means of monitoring chronic lead absorption in workers. (Ex. 105E; Ex. 309; Tr. 465; Ex. 99B; Ex. 343.) An elevation in ZPP may be the key to the multiple clinical effects of lead toxicity on several body systems, which become apparent as the exposure continues. (Tr. 466; Tr. 2432.) Substantiation for this is demonstrated by the correlation between elevated ZPP and other measurable biological parameters, including blood lead. For instance, it is reasonable to expect a lowered hemoglobin level as ZPP values increase, and significant correlations have been found between reduced hemoglobin and elevated ZPP. (Ex. 118C; Ex. 105E; Ex. 23(39).) Elevations in blood urea nitrogen (BUN) and serum creatinine (S-Creat) have also been found to correlate well with increased ZPP levels. Since both BUN and S-Creat are biological indicators of kidney damage, the monitoring of ZPP may serve as an early herald of renal toxicity. (Ex. 23(39).) There is also some evidence available that elevated ZPP values are found in workers with peripheral neuropathy and CNS symptoms. (Ex. 23(14); Tr. 2432; Ex. 23(39).) The accumulation of ZPP in the red blood cells quite clearly indicates a chronic interference by lead with heme synthesis. (Ex. 24(2).) In practice, the monitoring of ZPP on a bimonthly basis will provide an index of lead effect, as well as lead exposure, (Tr. 1312.) Moreover, in contrast to blood lead, the ZPP test is a quick, efficient, economic and safe means of monitoring workers. By utilization of the hematofluorometer, the ZPP test can be conducted at the worksite, and the workers can almost instantly see accurate test results. (Ex. 343; Tr. 433, 662.) Finally, as the result of the variability of lead absorption and its subsequent distribution within the body, blood lead levels fluctuate over short time spans, whereas ZPP levels remain relatively stable. (Ex. 343; Tr. 2445.) For example, ZPP, once it becomes the heme substitute has been shown to remain there for the lifetime of the red blood cell (about 120 days). The rate of production of ZPP is, however, a function of the concentration of lead within the bone marrow -- the primary site not only of heme synthesis, but of the blood cells themselves. (Tr. 2445.) During their testimony NIOSH discussed some of the weaknesses of the ZPP method:
One of the major problems with ZPP is that this is a very recently developed test and only limited data are available on blood lead-ZPP correlations. Further, ZPP may present calibration problems, and careful attention must also be given to quality control procedures. Under these circumstances, it would seem wise to develop a biologic screening approach which incorporates ZPP or an equivalent screening test with blood lead determinations. (Ex. 84)
OSHA agrees with these concerns but believes the utility of the ZPP method outweighs its drawbacks. In order to eliminate any uncertainties associated with the method OSHA will request NIOSH to carry out a careful evaluation of the ZPP technique especially with respect to quality control requirements and report their findings to OSHA at a later date.
If the employee's airborne lead exposure is above the action level at least 30 days a year, then, routine monitoring of an employee's blood lead and ZPP levels is to be made available at least every 6 months after the initial tests. If the PbB exceeds 40 ug/100 g the monitoring frequency must be increased to at least every 2 months and not reduced until two consecutive PbB's are below 40 ug/100 g. If PbB levels exceed the removal criteria under paragraph (k)(1)(i), a second PbB must be provided within 2 weeks to confirm the accuracy of the results. This followup is intended to assure that no unnecessary removals occur.
Since the goal of this standard is to maintain PbB's below 40 ug/100 g, individuals with higher levels should be monitored periodically to detect further unacceptable elevations. OSHA believes that every 2 months is a reasonable and adequately protective monitoring frequency for employees above 40 ug/100 g. For those below 40 ug/100 g but above the action level, semiannual monitoring is sufficient to detect elevated levels if they occur.
During the hearings there was considerable testimony which questioned the accuracy of blood lead determinations and suggested there were significant discrepancies in blood lead results depending on the source of testing. (Ex. 343; Tr. 1647, 1675, 1311-12.) A graphic illustration of the difficulties in measuring blood levels was provided by NIOSH in their submission of a report on the blood lead proficiency testing program of the Center for Disease Control which demonstrated that only 33 percent of the laboratories achieved an acceptable score (Ex. 86F). An acceptable score was based on the following criteria:
1. The accuracy required is 15 percent or 6 ug/100 ml, whichever is greater 2. Grade=Number of responses within acceptable range/number of challenges X 100.
Testimony at the hearings strongly suggests significant discrepancies in blood lead results depending on who is conducting the biological monitoring. While it is impossible to police all biological monitoring, some further beefing up of the "Accuracy" language is warranted to cut down on any attempts at cheating. Accordingly, we suggest that, at a minimum, blood lead samples be analyzed in established laboratories which are certified by the Center for Disease Control. (Ex. 452, pp. 52, 61.)
In addition, testimony from the Motor Vehicle Manufacturers Association (Ex. 402, p. 10), Drs. Wolfe (Tr. 8005-07) and Teitlebaum (Tr. 390-92) and the Amalgamated Clothing and Textile Workers Union (Tr. 7280) supported the recommendation that laboratory certification should be required. OSHA is concerned about the evidence which demonstrates the inadequacies in the proficiency records in blood lead determinations, and therefore based on the recommendations cited in the record will require blood lead samples be analyzed in laboratories which are licensed by the Center for Disease Control or which have received satisfactory grades in proficiency testing by CDC in the previous year. The accuracy requirements in the proposal will be adjusted to coincide with the accuracy requirements of CDC, i.e. 15 percent or 6 ug/100 ml, whichever is greater.
The standard requires medical examinations to be provided to an employee initially (for new workers, prior to assignment to a job where lead exposure would exceed the action level, and for current employees, within 180 days of the completion of air monitoring) and annually thereafter if the employee's blood lead level exceeded 40 ug/100 g at any time during the preceding year. Initial examinations are necessary to provide information to establish a baseline to which subsequent data can be compared. (Tr. 1405-06; 1501; 4358.) They will also be helpful in identifying individuals who would be at increased risk from lead exposure. (Tr. 1405-06; 1501.) Followup exams will document the continuing effect of lead exposure on individual workers and will facilitate a medical evaluation of whether continuing exposure is advisable.
The required examination includes a work history and medical history; a physical examination; determinations of blood lead level (PbB), hematocrit, hemoglobin, peripheral smear morphology and red cell indices; (Tr. 6562); levels of zinc protoporphyrin (ZPP), routine urinalysis (specific gravity, sugar, protein determinations, and microscopic examination), blood urea nitrogen (BUN), and serum creatinine (S-Creat). (Ex. 284A, p. E1.) This is similar to the requirement in the proposed standard except that mandatory pregnancy testing has been deleted and ZPP, BUN, and serum creatinine tests have been added. BUN and serum creatinine, although late indicators of kidney disease, are the best available routine diagnostic tests for kidney function and have been included for that reason. (Tr. 6562-63.) They can also be performed from the single blood sample taken for the other tests. Measurement of glomerula filtration rates or creatinine clearance would provide earlier indications of decreased renal function, but those tests are more in the nature of research techniques, are expensive, and would be clearly impractical for almost all employers to provide.
Medical consultations, with examinations as appropriate, are required to be provided upon request by an employer (1) whenever an employee has developed symptoms commonly associated with lead-related disease, (2) when an employee desires advice concerning the effects of lead on reproductive capacity, and (3) when an employee has demonstrated difficulty in breathing when wearing a respirator. Additional examinations must be made available when an employee is removed from exposure or otherwise limited under paragraph (k) of the regulation. The content and frequency of these examinations is to be at the discretion of the physician. Upon request of an employee, however, a pregnancy test or male fertility test (at a minimum analyzing sperm number, motility, and morphology) must be provided. These tests will facilitate the protection of reproductive capacity.
The medical surveillance provisions of the final standard contain a multiple physician review mechanism which gives workers an opportunity to obtain a second and possibly third opinion regarding the medical determinations made pursuant to the standard. An employee may designate a second physician to review any findings, determinations or recommendations of an initial physician chosen by the employer. Efforts are to be made to resolve any disagreement which may arise between the two physicians. Should they be unable to agree, a third physician they select will resolve the disagreement. OSHA's reasons for the provision of this review process are twofold: first, to broaden and strengthen the basis for medical determinations in situations where a worker questions the results of the initial examination or consultation; and second, to assure employee confidence in the soundness of medical determinations made pursuant to the standard. OSHA views the multiple physician review mechanism as an important element of the lead standard's medical surveillance program both due to the importance attached to medical surveillance by the Act, and due to the crucial role medical surveillance will play in the operation of the standard's medical removal protection program.
Medical surveillance pursuant to section 6(b)(7) of the Act must be provided by employers without cost to employees. Since the multiple physician review mechanism will be one means by which medical surveillance is provided to an employee, employers must bear the expense of this mechanism when it is used. In practice, the costs of this mechanism will not be burdensome, particularly since employers will have substantial control over the frequency of its use. Where employers carefully structure and administer medical surveillance programs which engender, merit and maintain worker confidence, workers will see no need to seek a second medical opinion.
OSHA's first reason for the provisions of a physician review opportunity is to strengthen and broaden the basis for medical determinations made under the standard in situations where a worker questions the results of an initial medical examination or consultation. The education and training provisions of the lead standard should assure that workers become knowledgeable in the nature and symptoms of the numerous lead-related diseases. Thus, when a worker disputes the results of an initial medical examination or consultation conducted by an employer-retained physician, adequate justification will exist for seeking a second medical opinion.
Two medical doctors testified in the lead proceeding that multiple physician review is a desirable diagnostic device as a general matter (Tr. 7375-7376; 7978-7980) for such reasons as the inherent biological variability of disease. (Tr. 7393-7394) The Black Lung medical surveillance and transfer program of the 1969 Coal Act includes multiple physician review of X-rays in all cases to improve the quality of medical diagnosis. (Tr. 7361-7362, 7386-7387, 7392-7393; Ex. 379A(2), p. 31) In light of the major shortage of trained and experienced occupational physicians in this country, and the number and varied nature of lead-related diseases, no one medical specialty is uniquely suited to provide error-free diagnoses under the lead standard. Accurate medical determinations under this standard are vital due to the interdependence between medical surveillance and the preventive medical removal protection program. Additionally, the facts that the standard's PEL is not a completely safe exposure level, that many lead workers have years of substantial prior exposure to lead, and that some lead-related diseases are reversible if detected at an early stage, support a conclusion that physician review would be appropriate in all cases of medical surveillance under the lead standard.
Rather than mandate additional opinions in all cases, however, OSHA has limited the opportunity for physician review to situations where a worker questions the findings, determinations or recommendations of the initial physician. OSHA's choice of a multiple physician review mechanism, as opposed to some other mechanism, is based on the common and increasing use of multiple physician participation in the formation of medical determinations. A formal physician review process is incorporated not only in the Coal Act program but in at least two other federal programs. A multiple physician review mechanism appears in physical qualifications and examinations regulations concerning motor vehicle drivers subject to the Federal Motor Carrier Safety Act. (Tr. 8098; Physical Qualifications and Examinations, 49 CFR sections 391.41-391.49 (1977)) A similar review process operates under medical care and supervision regulations of the Longshoreman's and Harbor Workers' Compensation Act. (Medical Care and Supervision, 20 CFR sections 702.401-702.422 (1977)) In addition, recent congressional attention has been focused on the benefits to be gained from review as to the advisability of surgical procedures. (Quality of Surgical Care; Hearings before the Subcommittee on Oversight and Investigations of the House Committee on Interstate and Foreign Commerce, 95th Cong., 1st sess. (1977).) The Department of Health, Education, and Welfare strongly promotes the use of second medical opinions in this regard (Hearings before the Subcommittee on Oversight and Investigation, supra, pp. 227-232 (statement of Hale Champion, Department of Health, Education, and Welfare Undersecretary)), and in recent weeks has launched a national campaign to urge patients to get a second doctor's opinion before surgery. (Washington Post, Sept. 14, 1978, p. A17, col. 2) Multiple physician review mechanisms are also widely used in the private sector. This mechanism frequently appears in conjunction with physical examination requirements contained in collective bargaining agreements (Ex. 365, p. 37), and commonly occurs in the determination of a worker's eligibility for a disability pension. (Tr. 7652, 7664-7666; Ex. 416C, pp. 11-12) The lead record contains some twenty specific examples of multiple physician review mechanisms. (Tr. 8224; Ex. 157, pp. 10-11; Ex. 158, p. 75; Ex. 368;, pp. 15-16; Ex. 369, p. 15; Ex. 379A, Att. 1; Ex. 404B (D-1), p. 4; Ex. 404B (D-2), pp. 16-17; Ex. 404B (D-4), pp. 26-27; Ex. 404B (D-5), p. 53; Ex. 404B (D-7), p. 13; Ex. 404B (D-9), p. 132; Ex. 415A, p. 23; Ex. 415B p. 74; Ex. 426, pp. 18-19; Ex. 427, p. 59; Ex. 430C-2; Ex. 430C-3; Ex. 430D(4b), Sections 78-79; Ex. 430 D(15), Art 27; Ex. 430H, pp. 64-65) The multiple physician review mechanism adopted by the lead standard incorporates characteristics common to many of these private sector and federal programs: The worker has an opportunity to select a second examining physician if dissatisfied with the results of the first examination, and if the two physicians disagree, they choose a third physician to resolve the differences of opinion. OSHA is convinced that the use of this multiple physician review mechanism will significantly improve the quality of the medical determinations provided under the lead standard.
OSHA's second reason for the provision of a physician review opportunity is to assure employee confidence in the soundness of the medical determinations made pursuant to the standard. Considerable evidence in the lead record documents the fact that workers question the objectivity of some employer-retained physicians. Furthermore, since there is documentation in the lead record of specific abuses by a portion of employer-retained physicians, OSHA has concluded that the problem cannot be ignored in the context of this standard.
Attachment C to the standard concerning Medical Removal Protection discusses the major importance of meaningful worker participation in the medical surveillance program created by this standard. The standard's ability to prevent material impairment to worker health and functional capacity -- particularly with respect to reproductive health, and the health of the long term lead worker -- will significantly depend on workers trusting and confiding in examining physicians. OSHA adopted the multiple physician review mechanism as a means of providing workers with an opportunity to obtain independent review of the determinations of physicians they do not trust. More importantly, use of this review mechanism should serve to engender worker trust and confidence in the employer-retained physician where merited. If workers distrust a company doctor and the diagnoses of a second physician on several occasions proves there is no basis for distrust, then workers will be much more likely to trust the company doctor in the future. If the choice of a second and third physician repeatedly results in medical determinations greatly at variance with that of the employer-retrained physician, then the multiple physician review mechanism will have served the beneficial purposes of (1) correcting inadequate medical determinations, and (2) exposing a major deficiency in the employer's medical surveillance program.
A substantial body of testimony in the lead proceeding focused on the lack of worker trust and confidence in some company doctors. (Tr. 2210-2211, 4254, 4261-4262, 4284, 4852, 5088-5090, 6026-6029, 6049, 7262, 7623, 7691-7692, 7976-7978, 8053, 8096, 8221-8223, 8241-8245; Ex. 167, pp. 2-4; Ex. 343, pp. 91-97, 103-104; Ex. 393, p. 6, Ex. 450B. pp. 3-5; Ex. 452, p. 66. The company doctor is often viewed as simply a paid agent of the employer, not as a neutral physician maintaining a close doctor-patient relationship with the employee. (Tr. 4284, 4780-4782, 4851, 5088-5090, 6032-6033, 7276-7279, 7623, 8053, 8223, 8240, 8245-8247; Ex. 393, p. 6; Ex. 450B, pp. 3-5.) The company doctor is sometimes viewed as an employer representative charged with minimizing the costs of successful workers' compensation claims, therefore at odds with devotion to worker health. (Tr. 4284, 4809-4811, 7276-7279, 8096; Ex. 379A, p. 12; Ex. 411B(4), pp. 5-6.) The lead record contains numerous reports of employer physicians refusing to divulge to an employee his or her blood lead level (Tr. 2569, 4757, 4773-4774, 4854-4855, 8076; Ex. 167, pp. 2-4; Ex. 450B, p. 5; See also, Tr. 4811), as well as numerous reports of employer physicians making gross misrepresentations of the toxic properties of lead -- for example, statements to the effect that one is not lead -- poisoned until one's teeth fall out, or Blacks are not susceptible to high blood lead elevations, or one is not lead-poisoned until irreversible nervous system damage occurs. (Tr. 533-535, 2169-2172, 4178-4179, 4757-4759, 4773-4774, 4806-4807, 5094-5095; Ex. 167, pp. 2-4.) Additionally, there was testimony of employer physicians reporting the results of medical examinations not to the worker, but directly to the employer such that the worker learned of his or her health status from a company official, not from the physician. (Tr. 4833, 8096.) Finally, evidence in the record points to a practice of some employer physicians failing to report crucial adverse health effects information either to affected employees or to the broader medical community. (Tr. 5007-5008, 5644-5647; Ex. 379B. p. 4.) In addition to the above, the lead record documents numerous instances of the practice by employers of prophylactic chelation, a grossly improper medical procedure dependent upon the active participation of the employer-retained physician. (Tr. 222, 226-240, 530-532, 1111-1112, 1272-1273, 2169-2172, 2200-2201, 2537-2539, 2542, 2676-2681, 2983(13)-2983(17), 4998-5002, 5022, 5102, 6026, 6043-6045, 6878-6879, 6881; Ex. 20; Ex. 84, p. 9; Ex. 86H; Ex. 117A; Ex. 118D; Ex. 166; Ex. 167, pp.; 5-7; Ex. 246A.) The practice has been condemned for several decades by the LIA itself (Tr. 3242-3245; Ex. 335, p. 88), though they note that the practice continues. (Tr. 3242-3245.) This practice vividly demonstrates that there are some physicians examining lead-exposed workers who fail to accord protection of worker health the priority it deserves. The multiple physician review mechanism is designed to check the influence of these physicians, and assure employees that no matter what the practices of the initial physician, the standard contains a mechanism whereby competent and impartial medical determinations can be achieved.
A final source of evidence indicating the need for a physician review opportunity comes from the ongoing debate within the occupational medical community. (Tr. 8241, 8247.) for example, the Journal of Occupational Medicine has in recent years carried numerous articles concerning worker confidence in employer-retained physicians. (Ex. 413A-413H.) Widely divergent opinions have been expressed in these articles, but a substantial portion of this professional commentary verifies the existence of a crisis of confidence. As one employer representative in the lead proceeding remarked:
I would like to assure you that the competent occupational health physicians that I know are as concerned and frustrated as you about the existence of poor practitioners of occupational medicine in the profession. (Tr. 5137.)
There is general recognition that a significant problem exists, and OSHA has adopted the multiple physician review mechanism in part to assure that the problem does not obstruct successful operation of the standard's medical surveillance program.
The preceding paragraphs explain in some detail OSHA's reasons for the inclusion of a multiple physician review mechanism since this is a relatively new component of OSHA health standards. (See, Medical Requirements, 40 FR 37650, 37658 (July 22, 1977), 29 CFR, 1910.411(f); Taylor diving and Salvage Co., v. Department of Labor, Civ. No. 77-2875 (5th Cir., filed Sept. 16, 1977.)) The discussion concerning and the inclusion of this mechanism, however, is not implicit criticism of the general medical community. Based on the lead record, OSHA has no cause to conclude that a majority of employer-retained physicians are not sincerely devoted to worker protection. Even worker representatives most critical of some "company doctors" agree that there are many competent and concerned corporate physicians. (Tr. 4281, 5088-90.) The multiple physician review opportunity contained in the final standard addresses problems presented by a minority of physicians. OSHA is convinced that there are situations where employer-retained physicians have a close doctor-patient relationship with lead exposed employees, and the employees have confidence in the physician's abilities and devotion. In those circumstances, there will seldom be any use of the multiple physician review mechanism. Where this close relationship of trust and confidence does not exist, however, an opportunity for a second medical opinion is appropriate.
The multiple physician review mechanism operates in a simple and straight forward fashion. It is important initially to stress that this mechanism is meant to apply to all forms of medical surveillance provided under the standard. If an employee's past, present, or future exposure to lead is a relevant consideration in the examination or consultation being provided, then the opportunity for an additional medical opinion must be provided.
The multiple physician review mechanism commences after an initial medical examination or consultation provided by a physician chosen by the employer. OSHA recognizes the value to employers and employees alike of the mechanism operating in an expeditious fashion, and thus has established explicit criteria for the beginning of the process. After an initial physician conducts an examination or consultation pursuant to the standard, the employer must promptly notify the employee of his or her right to seek a second medical opinion. This notification need be no more than an oral reminder of the existence and content of this multiple physician review mechanism. After this notification has been given, an employer may condition its participation in, and payment for, the mechanism upon the employee acting within 15 days after receipt of the foregoing notification, or receipt of the physician's written opinion, whichever is later. Before or within this 15-day period the employee must inform the employer (orally or otherwise) that the employee intends to seek a second medical opinion. The employee must also initiate steps within this time to make an appointment with a second physician. These steps would include actually making an appointment, or contacting a physician with the request that a referral to a specialist be arranged.
The standard contains no more limitation upon an employee's choice of a second physician than the standard places on an employer's choice of the initial physician. The second physician, like the initial physician, need only be licensed to practice medicine. There is no subspecialty of medicine solely concerned with lead-related diseases, and since lead-related diseases affect numerous systems of the body, it would not be appropriate to limit the choice of doctors to any one specialty. It is certainly to an employee's advantage to choose a competent physician, thus OSHA relies on this self-interest to assure the value of the second opinion. For example, where an employee's difference with the initial physician revolves around a particular body system -- e.g., nervous system -- it is likely that the employee will choose a specialist in that body system -- e.g., a neurologist. Where, however, the dispute revolves around several body systems, or the employee cannot identify one specific system, the employee will likely choose the general practitioner or internist most familiar with the employee's medical history or current health status.
The standard provides that the second physician shall review any findings, determinations or recommendations of the initial physician, and may conduct such examinations, consultations and laboratory tests as the second physician deems necessary to facilitate this review. An additional provision in the standard requires the employer to supply the same information to the second physician upon request that must be supplied to an initial physician. The second physician, therefore, is provided an opportunity to fully assess the employee's health status with access to the same background information supplied to the initial physician.
If the second physician's findings, determinations, and recommendations are the same as those of the initial physician, then the multiple physician review process comes to an end. If however, the opinions of the two physicians are in conflict, then the standard provides that the employer and the employee shall assure that efforts are made for the two physicians to resolve any disagreement. OSHA expects that the two physicians would as a general professional matter communicate with each other to resolve their differences, but the standard makes this expectation explicit. This professional interaction among peers should in most cases resolve any differences between the two physicians. The preceding elements of the multiple physician review mechanism assure that if differences of opinion remain, these differences are likely to be genuine and substantial.
Where the first two physicians have been unable to quickly resolve any differences of opinion with respect to an employee, then it is necessary for a third qualified physician to resolve the dispute. It is important that this third physician be competent to resolve the dispute, thus the standard provides that the third physician shall be designated by the employer and the employee jointly through their respective physicians. It is the responsibility of the employer and the employee to assure that a third physician is selected, but the selection is to be made by the two prior physicians. Since the third physician is chosen by the joint endorsement of the two prior physicians, the professional competence of the third physician will be assured.
The standard provides the third physician a full opportunity to review the findings, determinations, and recommendations of the prior physicians by conducting such examinations, consultations, and laboratory tests as the third physician deems necessary. The standard incorporates the expectation that the third physician will consult with the two prior physicians, and upon request the employer must supply the same information to the third physician given to the initial physician. The third physician is required to provide a written medical opinion to the employer, which will operate to resolve the disagreement between the earlier physicians. The standard finally requires the employer to act in a manner consistent with the findings, determinations, and recommendations of the third physician, unless the employer and the employee reach an agreement which is otherwise consistent with the recommendations of at least one of the three physicians. This requirement, however, is not intended to preclude an employer from establishing and implementing legitimate general medical criteria for its employees which may in special cases result in medical determinations even more conservative than the outcome of the multiple physician review process. The possibility of such a case arising, though, is extremely remote since there is no evidence that any employer using lead currently employs general protective medical criteria for its employees which are more restrictive than the final standard's requirements.
As with many of the provisions of the final lead standard, the success of the multiple physician review mechanism will largely depend upon employers and employees acting in a reasonable manner and with good faith. There are means by which an employer could attempt to frustrate the operation of this physician review process -- for example, by instructing the initial physician to refuse to agree on the selection of a third physician. Such actions, however, would constitute a deliberate violation of the standard since the regulation necessarily implies that the employer will act in a manner calculated to effectuate the multiple physician review mechanism. Operation of the multiple physician review mechanism also depends on the cooperation and good faith of the employee. In most cases, good faith on the part of the employee will be assured, since it is the employee who is seeking to reverse the initial medical determination. The employee will be eager for the review mechanism to proceed as quickly and efficiently as possible. This will especially be so since the medical removal protection provisions of the standard provide that in most situations, the employer may act consistent with the opinion of the initial physician pending the final medical determination of the the multiple physician review mechanism. In some cases, however, an employee might act in a manner clearly calculated to delay or otherwise prevent the review process from operating in an orderly manner. In this regard it is important to note that this physician review process is voluntary on the part of the employee, and the employee can terminate or abandon the review process at any time. Where an employee clearly acts to frustrate the operation of the multiple physician review mechanism, the employer may safely assume that the employee no longer desires the peer review process to continue.
Employer representatives raises in the lead proceeding a wide variety of objections to the multiple physician review mechanism. (Tr. 7461-7462, 7481-7482, 7527-7528, 7543-7546; Ex. 354(F), p. 3; Ex. 354(H), p. 3; 354(O), pp. 3-4; Ex. 354(V), p. 4; Ex. 354(W), p. 1; Ex. 354(Y), p. 5; Ex. 354(AA), pp. 13-15; Ex. 354(FF), p. 3; Ex. 354(GG), p. 2; Ex. 354(HH), p. 7; Ex. 385, pp. 13-14; Ex. 396A, pp. 4-5; Ex. 453, pp. 32-36; Ex. 457, pp. 35-36; but see Tr. 8460-8461; Ex. 354(P), p. 3; Ex. 354(II), p. 3; See also, Ex. 354(M), p. 2) Worker representatives, with one exception, strongly endorsed adoption of the mechanism. (Tr. 7202-7205, 7246-7247, 7264, 7609-7610, 7691-7692, 7976-7980, 8072-8074, 8224-8226; Ex. 354(D), p. 5; Ex. 372, pp. 8-9; Ex. 374, pp. 139-140; Ex. 378, pp. 4-5; Ex. 450B, pp. 3-10; Ex. 452, pp. 63-68; contra, Ex. 395, p. 3; See also, Ex. 464B, p. 2) Many of the employer objections have been dealt with by the preceding paragraphs explaining the justifications for, and operation of, the multiple physician review mechanism. The thrust of most employer objections was that this review process is unworkable and unduly burdensome. Were the physician review process adopted by the final standard a completely new and untried concept, then it would be appropriate for OSHA to discuss at greater length each specific criticism. As discussed earlier, however, the multiple physician review mechanism as adopted by this standard is currently in widespread use in a variety of contexts. No evidence was offered suggesting that any of these existing mechanisms have proven unworkable or overly burdensome. In view of this, OSHA rejects employer criticisms of the final standard's peer review process as being mere allegations unsupported by concrete evidence -- evidence which employers could easily have brought forward had it existed. OSHA is convinced that the multiple physician review mechanism can and will substantially add to the health protection afforded workers by this lead standard, and thus included this mechanism in the final standard.
The medical surveillance section of the standard includes a provision stating that the employer and employee or authorized employee representative may agree upon the use of any expeditious alternate physician determination mechanism in lieu of the multiple physician review mechanism. The only condition is that the alternate mechanism otherwise satisfy the standard's requirements. OSHA's inclusion of this alternate mechanism provision follows the recommendation of the United Steelworkers of America. (Ex. 452, pp. 63, 68) The lead record indicates that some employers and unions are negotiating on special medical determination procedures which are not founded upon an employer's unilateral choice of the examining physician. (Tr. 8243-8244, 8271-8272; Ex. 430C-2; Ex. 452, p. 68) For example, the parties might decide in cases of dispute for an employee to go directly from an initial physician chosen by the employer to an agreed upon final physician -- thus dispensing with the need for a second physician. Alternately, a final physician might be used in the first instance without recourse to other physicians. Or, an employee might be given the opportunity to choose this final physician. OSHA desires to encourage employers and employees to adopt medical determination procedures in which all parties have trust and confidence. The standard includes an explicit provision embodying this intention.
A major issue addressed in the proposed standard and throughout the rulemaking was chelation. The final standard prohibits prophylactic chelation of any employee by any person the employer employs, retains, supervises, or controls, and requires the employer to assure that any therapeutic or diagnostic chelation, if administered, is done under the supervision of a licensed physician in a clinical setting with thorough and appropriate medical monitoring.
Moreover, in cases where the examining physician determines that chelation is appropriate, the employee must be notified of this fact before such treatment. This should serve the purposes of informing the employee of a potentially harmful treatment, and affording the employee the opportunity to seek the review of this determination by another physician (see multiple physician review, above) thereby possibly acting as a check on an overly broad definition of "therapeutic" chelation by the examining physician.
A considerable body of testimony was presented concerning the use and abuse of chelation therapy in the treatment of lead poisoning. Experience accumulated by the medical and scientific communities over 20 years has largely confirmed the effectiveness of this type of therapy for the treatment of lead poisoning. It has also been established that there can be important adverse side effects associated with the use of chelating agents. The medical community has balanced the advantages and disadvantages resulting from the use of chelating agents in various circumstances establishing when the use of these agents is or is not acceptable. The general consensus of these professionals is that therapeutic chelation is acceptable but prophylactic chelation is not. Unfortunately, testimony given by lead workers has indicated that prophylatic chelation is occurring. Given that there is a glaring contradiction between theory and practice with regards to this issue, it is useful and necessary to review the health effects of chelation.
Blejer has described the development and functioning of the various chelating agents, stating:
A chelating agent is a chemical substance which will bind lead and certain other metals into a metal-chelate complex so as to make them biochemically and toxicologically inactive or unavailable. Chelation therapy in modern medicine had its inception during the First World War when dimercaprol, a heavy metal antagonist, was developed as an antidote for a lethal, arsenic-containing war agent called Lewisite. Thus, another name for dimercaprol is British antilewisite, or BAL for short. In the early 1950's a chelating agent began to be used:
Ethylene-diamine-tetraacetate, or just EDTA. However, an adverse, very serious side of EDTA was that it chelated calcium in the blood and body tissues and that, when severe enough, this removal or chelation of calcium -- an essential metal in human muscular biochemistry and function -- could produce potentially fatal tetany. Consequently, other EDTA compounds which contain calcium in the molecule were developed. One of these and currently the most widely used, is calcium disodium edetate -- also called Calcium EDTA, CaEDTA, Calcium Disodium Versenate, or Versenate. The calcium in CaEDTA is readily displaced by heavy metals, such as lead, to form stable complexes with the metallic ion locked or sequestered in the EDTA molecule. Following intravenous or intramuscular injections of Versenate, the chelate form is excreted in the urine with about 50% appearing in the first hour after administration.
In recent years another chelating agent called d-penicillamine, also known as pencillamine or Cuprimine, was developed for the treatment of excess copper in patients with a rare condition called Wilson's disease and also for the reduction of excess of cystine excretion in crystinuria, another rare condition. Judging from the California State reporting experience (Ex. 6(26)) in the last five or six years many physicians have begun to use pencillamine extensively instead of Versanate or CaEDTA, either in the treatment of lead poisoning, or to reduce increased levels of lead absorption -- as measured by elevated blood lead concentration -- among occupationally lead-exposed workers.
The route and mode of administration of these three chelating agents vary: BAL is administered by intramuscular injection only and, to my knowledge, it is very seldom used to treat occupationally lead-exposed workers. CaEDTA, on the other hand, is commonly used by physicians among these workers: It can be administered by mouth, intramuscular injection or intravenous infusion. The third therapeutic compound, penicillamine or Cuprimine, is given orally only. (Ex. 53, p. 7, 8, 9)
The possible adverse side effects of the various possible chelating agents were reviewed by several experts. Blejer stated:
The main adverse effect of dimercaprol or BAL are nervousness, nausea, a feeling of pressure in the chest, and a transient rise in blood pressure. Currently, the use of BAL is recommended in conjunction with CaEDTA for severe lead poisoning with acute encephalopathy in children only. According to Hamilton and Hardy (Ex. 23(30)). BAL is contra-indicated in adult lead poisoning because, although it increases lead excretion, it may increase lead toxicity by forming a BAL-lead complex which is more toxic than the lead per se. Further, in lead workers concurrently occupationally exposed to cadmium, iron or selenium, such as occurs in some primary nonferrous smelters, BAL is contraindicated because the BAL-metal complexes are more toxic especially to the kidneys, than any of the metals by itself.
Penicillamine or Cuprimine also has some very serious adverse effects which include the nephrotic syndrome and aplastic anemia. * * * (T)he drugs should not be given to patients allergic to penicillin because of cross-sensitivity between penicillin and penicillamine. Penicillamine has a plethora of other adverse effects which are detailed in the package insert which comes with capsules of Cuprimine. In part, that insert warns against its use during pregnancy because of penicillamine's affinity for metals and crystine and its effect on collagen. Also, it advises performing routine urinalyses, white and differential blood counts, hemoglobin determinations and direct platelet counts as well as frequent liver and kidney function tests during therapy. Penicillamine causes allergic skin reactions, including urticaria and may cause eye cataracts. Other adverse reactions that have been reported include hepatic dysfunction, tinnitus, falling hair, throbocytopernia, thrombotic thrombocytopenic purpura, bone marrow hypoplasia, leukopenia and granulocytopenia ranging in severity from asymptomatic and reversible to aganulocytois with fatalities. Thrombophlebitis, pancreatitis, cheilosis, glossitis, gingivostomatitis, sometimes with ulceration of the mucous membrane; polymyoitis; mammary hyperplasia; peptic ulcer; myasthenia; elastosis perforans serpiginosa have been reported but are unusual. A syndrome closely resembling disseminated lupus erythematosus and pemphigus have occurred, as well as severe and ultimately fatal glomerulonephritis and intraalveolor hemorrhage (Goodpasture's syndrome). Iron deficiency may develop, especially in menstruating women and in children. Reversible optic neuritis and cheilosis, possibly connected with pyridoxine (vitamin B6) deficiency, have been reported.
In fact, some of the above warnings, precautions and adverse reactions pertain to long-term uses of penicillamine and many of the adverse effects occur rarely. Nevertheless, one still wonders why many physicians are using this drug in the so-called prophylaxis of increased lead absorption, or even in the treatment of lead poisoning among lead workers.
One is even more puzzled about such uses, especially because penicillamine has not been approved by the U.S. Food and Drug Administration for the treatment of lead poisoning either in children or adults. As stated by the Commissioner of FDA in a related memorandum dated May 28, 1976, to the Director of NIOSH, "Penicillamine is a certified antibiotic drug which was approved in 1974 for Wilson's disease and cystinuria. At the present time it is also being studied under investigational new drug exemptions for its use in rheumatoid arthritis and chronic lead poisoning in children. There are currently nine active individual investigators (approved) for the study of the use of penicillamine in chronic lead poisoning in children." (Ex. 53, pp. 9-13)
Bridboard and Blejer, in a review article extensively discussed effects of CaEDTA, stated:
A number of studies suggest that oral EDTA increases the absorption of lead from the gastrointestinal tract in instances where exposure to lead continues to occur.
Other studies have observed T-wave changes in the electrocardiograms of patients given chelation therapy. Studies also suggest that the metabolism of trace metals other than lead may be affected by long-term chelation therapy.
The effects of lead and of EDTA on the kidneys were evaluated in two recent papers. Lead-poisoned rats were given injections of EDTA IP. Inclusion bodies (lead-protein complexes believed to possibly protect against lead effects) in renal cell nuclei were found in various stages of dissolution and migration out of the nucleus. Cytoplasmic vacuoles were observed which contained material that resembled portions of intact nuclear inclusions. Inclusion bodies have not been observed in renal biopsies of male workers occupationally exposed to lead who have been repeatedly treated with chelating agents. Excretion of lead through the kidneys appears to be less in older men compared to younger men who have nuclear inclusion bodies in their renal tubule lining cells. These data suggest that chelation therapy reduces the ability of the kidneys to protect themselves against the toxic effects of lead by virtue of the action of chelating agents in removing the lead-induced inclusion bodies. This conclusion is further supported by observations that renal tubula dysfunction may follow EDTA administration in lead poisoned children". (Ex. 86H, p. 7, 8)
Lilis and Fishbein, in their review, also evaluated the effects of CaEDTA. They noted the side effects associated with the use of this drug but concluded that most of these effects could be avoided if the drug was used appropriately. The stated:
Edetate disodium calcium has been shown, in terms of lead elimination and excretion, to be superior to both dimercaprol and penicillamine. The metal mobilizes as a nonionizable complex, and the maximum effect is reached six hours after intravenous administration, when 95% to 98% of the total amount has been excreted. When the therapeutic dosages of 50 mg/kg/day are not exceeded, the rate of administration is less than 20 mg/min, and the course of therapy restricted to five to seven days, practically no adverse side effects are observed.
Renal damage is the most important side effect associated with edetate disodium calcium chelation therapy; a small number of cases of acute tubular necrosis were described in the early days of edetate disodium calcium therapy. Most of these were due to very large doses, rapid administration, or severe preexisting renal disease (such as hypercalcemia and multiple myeloma)...
Various mucocutaneous lesions have been described in patients after prolonged administration of disodium edetate and edetate disodium calcium; one possible explanation considered was zinc depletion.
Treatment of lead poisoning with edetate disodium calcium given intravenously in five-day courses, with dosage and rate of administration not exceeding those previously mentioned and repeated if necessary after a free interval of two to five days, has been successful and has not been associated with clinically significant side effect. (Ex. 118D)
Wedeen concurred with Lilis' and Fishbein's conclusions concerning the acceptability and appropriateness of chelation therapy when administered therapeutically for treatment of lead poisoning. (Tr. 1745-1746) The decision to use chelating agents involves a weighing of the risks of the adverse effects of use against the benefits of use. The medical community has defined three separate circumstances under which chelation might be used and has generally established what is acceptable practice in each. "Therapeutic" chelation is the use of chelating agents for the treatment of the frank symptoms of lead poisoning. "Diagnostic" chelation is the use of chelating agents to assist in making the diagnosis of lead poisoning or lead induced disease. "Prophylactic" chelation was defined by Bridboard and Blejer "both as the routine use of chelating or similarly acting drugs to prevent elevated blood lead levels in workers who are occupationally exposed to lead or as the use of these drugs to routinely lower blood lead levels to predesignated concentrations believed to be `safe.'" (Ex. 86H, p. 20) OSHA agrees with this definition and emphasizes that an employer who hospitalizes an asymptomatic worker and has chelation carried out by a physician solely to reduce the worker's blood lead level will be performing prophylactic chelation. The use of a hospital and a physician is not the definition of therapeutic chelation. Routine chelation to reduce blood lead level is unacceptable whatever the setting.
The risks and benefits vary with the circumstances of use. Thus, in different circumstances the use of chelating agents might or might not be considered medically appropriate. With reference to therapeutic chelation. Bridboard and Blejer stated in their review that: "Most authorities agree the chelating or similarly acting agents have a proper place in the therapy of the acute symptomatology of severe lead intoxication, a condition accompanied by pronounced gastroenteric, neurologic and other symptoms and signs." (Ex. 86H p. 1) Those who testified were generally in agreement with this statement though there was some variation in what witnesses felt was the degree of severity of symptoms necessary for instituting chelation therapy. It was also generally agreed that chelation must be done only under careful medical supervision involving specific monitoring to minimize the risks involved.
Blejer testified extensively concerning the circumstances under which therapeutic chelation should occur:
The therapeutic use of chelating agents on occupationally lead-exposed adults is warranted only when there is frank and in my opinion, severe symptomatology of lead poisoning, such as the now-rare lead encephalopathy and the still-common lead colic. In most cases, it is my professional opinion that the health risks of administering chelating agents far outweigh the benefits of relieving mild to moderate symptomatology. In such cases, "natural deleading," i.e., removal from exposure, plus symptomatic/supportive treatment will achieve the same end results more safely and probably just as quickly.
Moreover, as demonstrated and published recently by Dr. Richard P. Wedeen, Professor of Medicine and a specialist in nephrology at the New Jersey Medical School in Newark, N.J. there is a state where golmerular filtration dysfunction due to lead may be reversible by intravenous administration of CaEDTA. In my opinion, for such purposes, in expert hands and in appropriate clinical facilities, chelation therapy could therefore be used in the absence of overt symptomatology. In all of these instances, however, the affected worker must be monitored clinically by physicians expert or competent in the treatment of lead poisoning, with the treatment administered in appropriate clinical facilities and, in the case of intravenous CaEDTA administration, on an in-patient basis. Needless to add, any such treatment would be thoroughly unproductive and essentially wasted if the worker is allowed to return to an uncontrolled lead exposure at the work place. As stated previously -- and it bears repetition often -- such treatment still constitutes secondary rather than primary prevention." (Ex. 53, p. 13, 14)
Chelation therapy should be resorted to only in cases of acute exacerbations in the course of chronic lead poisoning, such as encephalopathy, lead colic, or rapid and threatening increase of blood lead levels, and should always be done under careful medical supervision and after cessation of lead exposure. (Tr. 2643)
The use of chelation agents as a test for the existence of lead induced kidney disease as described by Wedeen, is a new and experimental diagnostic use of chelating agents. Blejer discussed a more conventional use of these agents for diagnostic purposes and suggested that in many cases diagnosis is possible without resort to the risks of chelation. (Ex. 53, p. 12-13) OSHA concurs in the view that in appropriate circumstances chelation may be used for therapeutic and diagnostic purposes.
The third type of use of chelating agents is "prophylactic" use. Prophylactic chelation is prohibited by the standard.
There was a remarkable degree of consensus in the testimony concerning this aspect of the proposal. Condemnation of prophylactic chelation was virtually universal. (Ex. 343, p. 91; Ex. 335, p. 88; Tr. 3242, 3683; Ex. 86H, pp. 8, 10, 11; Ex. 82, p. 12; Ex. 284A, p. 577; Ex. 53, p. 14) The health effects related to the use of chelating agents have been described above in some detail. With reference to the prophylactic use of these drugs, it is important to note certain particular effects. While the PbB levels are lowered by chelation, various authors have noted that in prophylactic chelation "effect" measures are not lowered to a comparable degree. Selander (Ex. 118D, ref. 12) noted that oral CaEDTA had little effect on ALA-U levels. The results of Fishbein et al. suggested that prophylactic chelation did not lower ZPP levels to a degree comparable to PbB levels. The study results of Fishbein et al. also suggested that workers who had been chelated prophylactically were not protected from neuropathy or lead colic effects. Thus they concluded that "without such cessation of exposure, chelating drugs may be ineffective, or even deleterious." (Ex. 105 D) Similarly. Dr. Finklea has stated that:
We in the National Institute for Occupational Safety and Health also strongly oppose this practice. Prophylactic treatment of workers with chelating agents while failing to control the source of lead exposure in effect places workers in double jeopardy, by virtue of the potential harmful effects of long term versenate therapy particularly on the kidneys combined with continued excess exposure to lead, a known renal toxin. (Ex. 246A)
Prophylactic administration of CaNa, EDTA by whatever route under conditions of continued lead exposure is judged to be particularly hazardous. Use of chelating agents is not an adequate substitute for engineering controls and proper industrial hygiene practices. Both lead and CaNa, EDTA in sufficient dosages are established to be toxic to the kidneys. Prophylactic chelation may decrease the ability of the kidneys to protect themselves against the toxic effects of lead. A recent mortality study of workers exposed to lead conducted by Cooper and Gaffey, (Ex. 5(28)), for example, demonstrated an increase in deaths from end stage renal disease. In conclusion, prophylactic use of chelation to control lead absorption represents an unacceptable medical practice that cannot be condoned. (Ex. 6(19), p. 20)
Lilis and Fishbein reviewed the effects of prophylactic chelation and similarly concluded that:
Oral prophylactic treatment with chelating agents such as edetate disodium calcium or penicillamine is contraindicated for the prevention of lead poisoning in workers exposed to lead. Among the reasons are the poor absorption of edetate disodium calcium from the gastrointestinal tract, the concomitant possible increased absorption of ingested lead, and the unsatisfactory effect of oral administration of edetate disodium calcium on blood lead, urinary coproporphyrin, and amino levulinic acid indicating a failure to prevent adverse metabolic lead effects. These constraints explain the repeated failures of oral chelation therapy with symptomatic lead poisoning developing in some workers in spite of the prophylactic treatment.
Further, the effect of long-term chelation therapy on serum iron, copper, magnesium, and zinc levels and the probable interference with metal-dependent enzymatic activity adds to the disadvantage of this treatment, as do the side effects of penicillamine, such as renal damage, leukopenia, agranulocytosis, eosinophilla, and decreased serum iron levels.
Finally, it may not be unimportant that alteration of biological measurements used to estimate the current extent of absorption of lead by individuals occupationally exposed occurs and is bound to make the clinical management of lead disease more difficult and confused.
Adequate control of occupational lead exposure cannot and should not be replaced by inappropriate and potentially hazardous attempts at prophylactic treatment. (Ex. 118D)
Moreover the membership of the American Occupational Medical Association at a general session in 1976 approved and adopted a statement of ethics which in essence stated that "the use of chelating agents as a prophylactic measure to prevent lead intoxication among workers in place of environmental controls would be considered as unethical practice of medicine and the subject physician would be subject to censure." (Tr. 251) In his testimony Blejer expressed his opinion that routine administration of chelating agents constitutes "prophylactic" chelation: "Routine administration of chelating agents amounts to essentially prophylaxis, meaning you are just treating the blood leads or the symptomatology and you are sending the individual back to the exposure, * * * to be re-exposed." (Tr. 243) These views were supported by Epstein (Tr. 1112) and Finklea. (Ex. 246A) In view of the strong criticisms that have been made against prophylactic chelating and in view of the fact that such warnings have a twenty year history, it is tragic that any major instances of prophylactic chelation should have occurred. Nevertheless, extensive testimony was presented which did demonstrate that prophylactic chelation has occurred and is occurring in workplaces throughout the country (Tr. 5631, 5634, 6125); hence the necessity for prohibiting any chelation which falls within the Blejer and Bridbord definition of "prophylactic".
Various workers and their union officials testified concerning their direct experiences with prophylactic chelation.
George Becker of the United Steelworkers of America, (USWA) testified concerning his personal experience with prophylactic chelation. (Tr. 4991-4992) He also testified that one worker told a NIOSH investigator in 1973 that he took as many as 250 versenate pills a week "to make sure that he didn't become leaded." (Tr. 4992) In addition, union testimony reinforced the experience of Becker.
Givens, Teamsters (Tr. 2171), Mirer, UAW (Tr. 446), Beliczky, Rubber Workers (Tr. 2537-39; Ex. 38c, p. 4), all discussed the indiscriminant use of prophylactic chelation.
One of the most thoroughly studied cases of prophylactic chelation presented were the combined cases of the NL and Quemetco smelters studied by Fishbein et al. Becker described his initial contacts with the problems at these plants through USWA Local 5554:
Employees from each smelter had complained to the company doctor of nausea, stomach cramps, headaches and fatigue. Chelation was still practiced, although under different circumstances. Oral chelation had been halted at the NL smelter. Instead, employees were receiving EDTA administered solution intravenous IV treatments at the local hospital on an outpatient basis * * *.
The situation at Quemetco smelter appeared to be even worse. Oral chelation, pills of the cuprimine variety were being distributed by the company doctor. In response to my expressed concern about this form of chelation I was told by Quemetco's doctor that, "They are absolutely safe and if I had my way they would be handed out to the lead workers like salt." (Tr. 4999)
The study of Fishbein et al. gives a more detailed description of what was occurring in these smelters:
The 47 workers in Plant 1 and 24 in Plant 2 had at least one course of chelation therapy, but 45 (24 in Plant 1 and 21 in Plant 2) had had it repeatedly (up to 10 times)(Table 16). The fact that there were more workers with repeated courses of chelation therapy in Plant 2 is consistent with the longer duration of employment of these workers.
Over the years, histories given indicated that several patterns of chelation therapy had been followed. For example, the duration of courses of intravenous versenate varied from 3 days to 10 days. The prevailing practice in one plant had been to administer chelating agents in most cases without removing the worker from his usual lead exposure. Under such circumstances, it was not surprising that chelation therapy had to be used frequently, since the deleading effect of the chelating agent would be counterbalanced by continuous exposure and absorption of lead.
Most workers were given chelation therapy on an ambulatory basis. However, 14 had had hospital admissions for lead poisoning over the years, for what seemed to have been acute episodes (colic) in the course of their chronic lead poisoning. Change in job assignment, to areas of lesser lead-exposure, was reported by only 23 of the examined workers. The fact that chelation therapy had been used to a much larger extent than had removal from exposure might have been due to the existence of rather homogenous air lead levels in the plants, which had large open workspaces. (105 F. pp. 30, 31)
Frequency of Chelation Therapy in Secondary Lead Smelter Workers _____________________________________________________________________ Total Repeated number Chelation courses of examined therapy chelation therapy _____________________________________________________________________ No. Pct. No. Pct. Plant 1 ....... 113 47 42 24 20 Plant 2 ....... 45 24 53 21 44 __________________________________________________ Total ......... 158 71 45 45 27 (Ex. 105F. Table 16) _____________________________________________________________________
The California State Occupational Disease report data . . . as well as the results of the Indianapolis, Indiana, and Vernon, California, clinical field surveys -- conducted by the Environmental Sciences Laboratory, Mt. Sinai School of Medicine, City University of New York, as reported in May 1976 and January 1977, respectively -- all indicate that not only is such chelation therapy with CaEDTA and/or penicillamine quite prevalent, but also that so has been the practice of administering CaEDTA intravenously on ambulatory, nonhospitalized basis, such as in a physician's office or even in a plant's dispensary or first-aid room. Moreover, in practically all of these cases there were not available data to indicate that the occupationally lead-exposed workers being thus medicated were being monitored for any of the untoward or adverse effects or oral penicillamine and/or CaEDTA or of intravenous CaEDTA administration. Although it is true that in many cases such lead-exposed workers were being medicated by physicians other than those retained full or part-time by the plant, it is also true that some of these workers were thus medicated by company-designated and/or employed physicians sometimes, as already stated, right in the physician's office or even at the work place itself. (Ex. 53, p. 18)
In summary, the use of chelating agents is known to involve certain health risks. These risks are minimized when the drug is administered under a strictly controlled setting with appropriate medical monitoring, over a short period of time, and in appropriate dosages. The use of such agents prophylactically is considered inappropriate. The repeated use of such compounds is not at all appropriate when an alternative such as controlling employee exposure is possible.
OSHA believes that chelating agents, such as calcium disodium edetate (EDTA), and penicillamine, are useful in the therapy of acute overexposure to lead. Such therapy should be done under the supervision of a licensed physician in a clinical setting with thorough and appropriate medical monitoring of the patient. Medical experts were not uniformly in agreement concerning the circumstances under which therapeutic chelation should be used, and OSHA can not define appropriate medical practice for the individual patient. Such decisions must be made by the physician, exercising sound medical judgment after an evaluation of all the relevant factors.
The testimony given by workers and health professionals which clearly indicated that prophylactic chelation has occurred and continues to occur in spite of the well established body of medical knowledge opposing it is of grave concern to OSHA. OSHA believes that the record indicates a need for extensive education both of health professionals and of workers concerning the circumstances of use and abuse of chelating agents and a mandatory prohibition in the standard of improper use of chelating agents.
The final standard requires, under the authority of section 6(b)(7), that the employer pay the costs of medical surveillance and make all the tests or procedures available to employees at a reasonable time and manner. The proposed standard required medical surveillance to be provided during the employee's normal working hours, but as was pointed out by several parties (e.g., Ex. 3(31)), medical personnel would probably not be available outside the regular daytime hours. Thus, employees who worked night shifts could not have examinations during their regular working hours. OSHA's concern is that medical surveillance is provided at a time and in a manner so as not to discourage employees from participating in the program. A standard of reasonableness should accomplish this goal.
K. MEDICAL REMOVAL PROTECTION: PARAGRAPH (K)
L. EMPLOYEE INFORMATION AND TRAINING: PARAGRAPH (L)
The final standard requires the employer to provide an information and training program for all employees exposed to lead above the action level. Information and training are an essential aspect of the overall protection of employees who can do much to protect themselves if they are informed of the nature of the hazards in the workplace. To be effective an employee education system must appraise the employee of the specific hazards associated with his work environment, protective measures which can be taken, and his rights under the standard. The need to train employees was agreed upon by virtually all of the participants in the rulemaking proceeding, and a training requirement was included in both the NIOSH Criteria Document (Ex. 1) and the proposed standard.
In addition, OSHA will require that materials provided to the employer by OSHA be made readily available to all affected employees. This requirement was not included in the proposal which only specified that the standard and its appendices be available. There was testimony which suggested OSHA "track employer compliance with the educational requirements very closely." (Ex. 343, p. 106.) While OSHA believes employer compliance with this provision is essential, the agency considers it important to assist in this process by providing both written and audio visual materials to the employer for use in training. OSHA intends to develop, in the future, specific safety and health training and education materials on lead for distribution and presentation to the employees by employers in addition to the training requirements in this regulation. These materials will inform employees of the hazards of exposure to lead and appropriate protective measures as discussed in this preamble and final regulation. Where these materials are designated by the Assistant Secretary, the employer will be required to include them as part of his education and training program.
Although the emphasis of education and training is for the worker subject to exposure at or above the action level, training requirements exist which must be observed even if the initial monitoring or determination indicates that exposures are below the action level. Specifically, the final standard's accessibility of information requirements extend to all employees. The employer must also inform all employees, including those below the action level, of the contents of Appendices A and B of the regulation, when published.
The training program for employees subject to exposure to lead at or above the action level or for whom the possibility of skin/eye irritation exists, is generally in keeping with the proposal. During the hearings there was considerable testimony on the need to inform workers, both male and female, of the severe effects on the reproductive system from exposure to lead. (Tr. 657, 694, 4511, Ex. 343, p. 106.) For example, Andrea Hricko stated:
Employee and job applicants must be informed that excessive exposures to lead have resulted in reproductive difficulties, including fertility problems, menstrual disorders, stillbirths, miscarriages and other hazardous effects so that they understand the significance of blood, sperm, and pregnancy testing (Tr. 694).
OSHA is in complete agreement with this view and therefore will require the employer to develop an education program which addressed the danger of exposure to lead on the reproductive system, and on employee options as part of the medical surveillance program, e.g., fertility and pregnancy testing. OSHA believes this is a crucial provision of the standard. A worker, whether male or female, who is fully informed of the hazards of lead will be better able to avoid the adverse reproductive effects documented in the preamble. The knowledge of the hazard in this instance is crucial since there is concern that workers whose blood leads do not exceed the 30 ug/100 g level may still be at risk especially if they have extended tenure in a lead industry.
The training program is required to be completed for employees initially covered by the standard within 180 days of the effective date, thus allowing 90 days after the completion of initial monitoring, and for all new employees at the time of initial assignment to areas where there is a possibility of exposure over the action level. OSHA believes that it is important to train employees as soon as possible in order to maximize the benefits of the training program, and has acted accordingly.
The standard requires that the training program be provided at least annually. OSHA believes that an annual training program is both necessary and sufficient to re-inform the employees of the hazards and their rights and duties under the standard.
M. SIGNS: PARAGRAPH (M)
The final standard requires a sign to be posted in areas where lead exposure exceeds the PEL. The standard specifies the legend for these signs.
The proposal did not require the posting of signs, but raised the issue of whether signs or labels would be appropriate. However, it is important, and section 6(b)(7) of the Act requires, that appropriate forms of warning, as necessary, be used to appraise employees of the hazards to which they are exposed in the course of their employment. OSHA believes, as a matter of policy, that employees should be given the opportunity to make informed decisions on whether to work at a job under particular working conditions. Furthermore, when the control of potential safety and health problems involves the cooperation of employees, the success of such a program is highly dependent upon the worker's understanding of the hazards attendant to that job.
In light of the serious nature of the hazard of exposure to lead, OSHA believes that sign posting is needed as well as periodic training to adequately inform employees of the poisoning hazard. The appearance of the phrase "Poison" on the warning sign will serve as a daily reminder of the hazards and as an objective check on whether employees are actually being informed of this hazard. The warning signs will inform all employees entering such areas of the need to utilize respirators and other protective equipment which the employer is to provide. Additionally, the phrase "No Smoking or Eating" relates directly to requirements in the standard which limit activities within lead contaminated areas. (See discussion in paragraph on Hygiene Facilities and Practices.)
N. RECORDKEEPING: PARAGRAPH (N)
Section 8(c)(3) of the Act (29 U.S.C. 657) mandates the inclusion of provisions requiring employers to maintain accurate biological and environmental monitoring records of employee exposures to potentially toxic materials. It also provides that employees or their representatives have access to such records.
The final standard requires records of exposure measurements. The records required include name and job classification of employees measured, details of the sampling and analytic techniques, results, and type of respiratory protection worn. The standard also requires records of medical surveillance (biological monitoring & medical exam results). These include name of employees, the physician's written opinion. and a copy of the results of the examination. These records must be kept for 40 years or for at least 20 years after termination of employment, whichever is longer.
The final standard also contains a limited recordkeeping requirement concerning temporary medical removals effected pursuant to the medical removal protection program. The employer must establish and maintain an accurate record for each employee removed from current exposure to lead. The record is to contain four entries each time an employee is removed. First, the employee must be identified by name and social security number. Second, the date of removal and return must be stated. Third, the employer must briefly explain how each removal was or is being accomplished. This description need be no more detailed than such statements as "Employee X was transferred from position A to position B during the entire period of removal," or "Employee X was laid off for the entire period of removal, " or "Employee X is currently working half shifts until a transfer opportunity becomes available." Forth, the record must indicate whether or not the reason for the removal was an elevated blood lead level. If removal is due to a reason other than an elevated blood lead level, this precise reason should not be stated so as to prevent disclosure of confidential medical information.
The purpose of the foregoing recordkeeping requirement is to enable the Secretary, employees, and their authorized representatives to assess the operation of, and an employer's compliance with, the medical removal protection program. The limited but pertinent information contained in these records will, in most cases, enable these assessments to be made without interviewing large numbers of employees or placing undue burdens on employers by requiring further time consuming and burdensome examinations of payroll, production, or confidential medical records -- examinations which likely would be necessary in the absence of the standard's limited recordkeeping requirement. Due to the limited purposes to be served by these records, the standard requires an employer to maintain each medical removal record only for so long as the duration of an employee's employment.
In the final standard, there have been deletions in two areas of recordkeeping which OSHA has determined to be excessively costly and minimally effective: (1) mechanical ventilation measurements and (2) employee training. A third deletion has been made, specifically in the area of medical surveillance records. The proposal required that a signed copy of any employee's refusal to participate in the medical surveillance program be included among the other records. This provision has been removed. OSHA believes that the problem of employee refusal will be mitigated by the standard's Medical Removal Protection program, which will minimize disincentives to worker participation. Therefore, this provision has been deleted in the final standard.
The participants at the hearing generally agreed with the necessity for keeping records but objected to the length of the record retention period. The extended retention period is needed for several purposes. Lead is known to have both acute and chronic effects, depending on the level and duration of exposure. The onset of clinical symptoms may occur many years after exposure. OSHA requires these records be maintained to document the medical and exposure history of the worker in order to assist the physician in determining whether lead was an etiologic agent in a disease progression. For example, renal and neurological disease do not necessarily have early warning indicators which physicians might use for evaluation. The records will serve to aid the physician in determining the dose to the worker over his work tenure.
OSHA is also concerned that the physician be able to follow asymptomatic workers who have been exposed to low lead levels over long periods of time, in order to ascertain the long-term effects of low level exposure. In this regard, another important function the combined records serve is to provide a data base for much-needed scientific and epidemiological research into the effects of chronic low level lead exposure. Lastly, maintenance of records for 40 years will enable a future review of the adequacy of the standard.
The final standard requires that records be made available to the Director and Assistant Secretary, the environmental and biological monitoring records be available to employees and their authorized representatives, and medical records to an employee or to a physician or other person designated by an employee or former employee. These provisions carry out statutory requirements. In addition, it is necessary for the Assistant Secretary and director to have access for enforcement and research purposes. Employees and their representatives need access to both environmental and blood lead level monitoring records to assess an employer's progress in (1) controlling worker exposure to lead, and (2) complying with the lead standard, particularly the medical removal protection provisions. Blood lead level records are particularly useful in this regard. Consistent with the current widespread dissemination of individual blood lead level results, and the need for employers and employees to have this data, the standard makes blood lead level results available to all employees and their representatives. In so deciding, the agency has carefully balanced the pressing need for worker access to this limited form of medical data against the confidentiality that would normally be afforded to most forms of laboratory test results.
The transfer provisions in the proposal have been left unchanged except that NIOSH is to be notified at the expiration of the retention period so that it can determine if the records are still needed for research purposes.
O. OBSERVATION OF MONITORING: PARAGRAPH (O)
Section 8(c)(3) of the Act requires that employers provide employees or their representatives with the opportunity to observe monitoring of employee exposures to toxic materials or harmful physical agents. In accordance with this section and consistent with the proposal and other OSHA standards, the standard contains provisions for such observation. To insure that this right is meaningful, observers are entitled to an explanation of the measurement procedure, to observe all steps related to the measurement procedure, and to record the results obtained. Since results will not normally be available at the time of monitoring, the standard has been clarified to indicate that the observers are entitled to receive the results of the monitoring when returned by the laboratory. The observer, whether an employee or designated representative, must be provided with, and is required to use, any personal protective devices required to be worn by employees working in the area that is being monitored, and must comply with all other applicable safety and health procedures.
P. EFFECTIVE DATE: PARAGRAPH (p)
The effective date is February 1, 1979. The approximate three month period between the issuance of the standard and its effective date is intended to provide sufficient time for employers and employees to become informed of the existence of the standard and its requirements.
Any petitions for administrative reconsiderations of this standard or for an administrative stay pending judicial review must be filed with he Assistant Secretary of Labor for Occupational Safety and Health within 45 days of the publication of this standard in the FEDERAL REGISTER. Any petitions filed after this date will be considered to be filed untimely. This requirement is considered essential to permit the Agency to give full consideration to each petition and respond in advance of the effective date of the standard.
Q. APPENDICES: PARAGRAPH (q)
The appendices included with the regulation are intended to provide information and are not intended to create any additional obligations not otherwise imposed.
R. STARTUP DATES: PARAGRAPH (r)
Startup dates for specific provisions have been extended from the proposal. This is based on OSHA's experience with other standards as to the time required for employers to complete air monitoring, and medical surveillance, and to obtain necessary equipment, respirators, and protective clothing. If there is no specific start up date set forth in the standard, then the startup date is the effective date of the standard. If the time period for meeting any of these startup dates cannot be met because of technical difficulties, any employer is entitled to petition for a temporary variance under section 6(b)(6)(A) of the Act.
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