2

Occupational Standards and Guidelines for Lead

This chapter describes occupational exposure guidelines for lead. The US standards and guidelines of the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the American Conference of Governmental Industrial Hygienists (ACGIH®) are presented first and then guidelines of other countries, including those of the European Union, Germany, and the United Kingdom. Features common to the guidelines include an airborne exposure limit as an 8-hour time-weighted average (TWA) and a recommended blood lead level (BLL) to prevent adverse health effects. Table 2-1 presents a comparison of the various occupational-exposure guidelines.

US STANDARDS AND GUIDELINES

Occupational Safety and Health Administration Lead Standard

OSHA was created in 1970 on passage of the Occupational Safety and Health Act (OSHAct), Public Law 91-596. The OSHAct became effective on April 28, 1971, and authorized the federal government to establish and enforce standards for occupational safety and health. The intention of the OSHAct was to ensure that all employees in the United States had safe working conditions. The OSHAct also required the head of each federal agency (except the US Post Office) to establish an occupational safety and health program that is consistent with the standards promulgated under the act.

The OSHA lead standard for general industry (29 CFR 1910.1025) was promulgated on November 14, 1978. It applied to all occupational exposures to lead except those associated with construction or agricultural work. The key components of the lead standard were the setting of a permissible exposure limit (PEL) of 50 μg/m3 as an 8-hour TWA and the institution of a medical surveillance program for all employees who are or may be exposed above the 8-hour TWA action level (30 μg/m3) for more than 30 days per year.



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2 Occupational Standards and Guidelines for Lead This chapter describes occupational exposure guidelines for lead. The US standards and guidelines of the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the American Conference of Governmental Industrial Hygienists (ACGIH®) are presented first and then guidelines of other countries, including those of the European Union, Germany, and the United Kingdom. Features common to the guidelines include an airborne exposure limit as an 8-hour time-weighted aver- age (TWA) and a recommended blood lead level (BLL) to prevent adverse health effects. Table 2-1 presents a comparison of the various occupational- exposure guidelines. US STANDARDS AND GUIDELINES Occupational Safety and Health Administration Lead Standard OSHA was created in 1970 on passage of the Occupational Safety and Health Act (OSHAct), Public Law 91-596. The OSHAct became effective on April 28, 1971, and authorized the federal government to establish and enforce standards for occupational safety and health. The intention of the OSHAct was to ensure that all employees in the United States had safe working conditions. The OSHAct also required the head of each federal agency (except the US Post Office) to establish an occupational safety and health program that is consistent with the standards promulgated under the act. The OSHA lead standard for general industry (29 CFR 1910.1025) was promulgated on November 14, 1978. It applied to all occupational exposures to lead except those associated with construction or agricultural work. The key components of the lead standard were the setting of a permissible exposure limit (PEL) of 50 µg/m3 as an 8-hour TWA and the institution of a medical surveil- lance program for all employees who are or may be exposed above the 8-hour TWA action level (30 µg/m3) for more than 30 days per year. 29

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30 Potential Health Risks to DOD Firing-Range Personnel TABLE 2-1 Occupational-Exposure Guidelines for Lead Air-Exposure Guideline (8-h time-weighted Recommended Limit Agency average) for Blood Lead Level Year Approved Occupational Safety 50 µg/m3 40 µg/dL 1978 and Health Administration National Institute for 50 µg/m3 60 µg/dL 1978 Occupational Safety and Health American Conference 50 µg/m3 30 µg/dL 1987 (air) of Governmental 1995 (blood) Industrial Hygienists European Council 150 µg/m3 70 µg/dL 1998 Directive 98/24 European Union 100 µg/m3 30 µg/dL 2002 Scientific Committee on Occupational Exposure Limits German Commission None, because 40 µg/dL for men and 2006 for the Investigation of probably women over 45 years old Health Hazards of carcinogenic 10 µg/dL for women under Chemical Compounds in humans 45 years old in the Work Area United Kingdom 150 µg/m3 25 µg/dL for women of 2002 Health and Safety reproductive age Executive 40 µg/dL for people 16-17 years old 50 µg/dL for all other employees Historical Context In the years preceding the promulgation of the OSHA lead standard, air- borne lead exposure limits of 150-200 µg/m3 and BLLs of 80 µg/dL were fol- lowed (43 Fed. Reg. 52952 [1978]). Data that emerged in the middle 1970s sug- gested that those levels were too high and should be reduced. OSHA provided the following rationale for the final standard (40 Fed. Reg. 52952 [1978]): Health Effects: OSHA relied on studies that reported adverse health ef- fects in conjunction with BLLs and considered both effects from acute exposure and, to the extent that they were known, effects of long-term lead exposure. In

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Occupational Standards and Guidelines for Lead 31 addressing the array of adverse health effects, OSHA cited five stages of a dis- ease process—“normal, physiological change of uncertain significance, patho- physiological change, overt symptoms (morbidity), and mortality” (p. 52594) and recognized that there was not a sharp distinction between stages but rather that they are on a continuum. OSHA went on to state that an adopted standard “must prevent pathophysiological changes from exposure to lead”. In question- ing whether both “clinical and subclinical effects” of exposure should be con- sidered, OSHA judged that those terms represented “vast over-simplifications of a disease process and, therefore . . . avoided their use in the final standard” (p. 52963). OSHA regarded subclinical effects to be the “early to middle stages in a continuum of disease development process” (p. 52963). OSHA summarized key studies on heme-synthesis inhibition (inhibition of the enzymes delta-aminolevulinic acid dehydrogenase [ALAD] and ferroche- latase) and anemia; on neurologic effects (central nervous system symptoms, behavioral symptoms, peripheral nerve effects, and results of nerve-conduction testing); on renal effects; and on reproductive effects. Except for reproductive effects, the evidence demonstrated adverse pathophysiologic effects at BLLs over 40 µg/dL; thus, 40 µg/dL was considered the upper acceptable limit. Con- cerning reproductive effects and effects on children (hyperactivity at BLLs as low as 25 µg/dL), “OSHA concludes that in order to protect the fetus and new- born from the effects of lead on the nervous system, blood lead levels must be kept below 30 µg/100 g [30 µg/dL]” for workers who wish to plan pregnancies (40 Fed. Reg. 52960 [1978]). OSHA also acknowledged at the time that for many of the adverse health effects there was evidence of a dose-response rela- tionship but that the “no-effect level” remained to be determined. Air-Blood Relationships: Although industry representatives maintained that BLLs could not be correlated with or predicted from air lead concentration, OSHA judged that despite some data limitations the collective data could be used to make estimates. OSHA described some studies that provided linear models and regression analyses. It relied predominantly on a physiologic model originally developed by S. R. Bernard and adapted by the Center for Policy Al- ternatives (CPA) that “combines experimentally observed properties of mam- malian lead transport and metabolism, including consideration of the dynamics of blood lead response to long term exposure” (40 Fed. Reg. 52961 [1978]). The model also accounted for “the observed physical properties of airborne particu- lates encountered in the workplace, in order to produce a complete and accurate picture of the response of blood lead levels to particulates” (40 Fed. Reg. 52967 [1978]), and CPA included specific consideration of individual variability in response to air lead. The model was applied to exposures at air concentrations of 50, 100, and 200 µg/m3, and the results were used to predict the percentage of workers that would fall within different BLLs. The results demonstrated the benefit of setting an air concentration of 50 µg/m3 to reduce the number of workers who had predicted BLLs over 40 µg/dL. (See Chapter 3 for the commit- tee’s evaluation of the model and its assumptions.)

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32 Potential Health Risks to DOD Firing-Range Personnel Approach to the Rule: OSHA’s reasons for placing primary reliance on an air PEL for compliance and citations rather than on biologic monitoring in- cluded these: evaluation of the industrial environment focused on the direct measurement and control of sources of lead exposure whereas biologic monitor- ing was designed to ascertain problems of individual workers and was an indi- rect measure, or check, of the control of lead; biologic monitoring was not feasi- ble for compliance and citation purposes; and biologic monitoring alone might not provide adequate protection for workers, because excessive exposure to lead would not result immediately in excessive BLLs. Permissible Exposure Limit The lead standard requires employers to ensure that no employee is ex- posed above the PEL. In 1971, OSHA set the initial PEL for lead at 200 µg/m3 as an 8-hour TWA. The PEL was based on American National Standards Insti- tute consensus standard z37.11-1969. The consensus standard did not provide any justification for its level of 200 µg/m3 (43 Fed. Reg. 52952 [1978]). OSHA also used the ACGIH threshold limit value (TLV®) as a national consensus stan- dard to establish the initial PEL (Public Law 91-596). The 1968 TLV for lead was also 200 µg/m3 (43 Fed. Reg. 52952 [1978]). OSHA was required in the OSHAct to set standards by using national consensus standards within 2 years of the OSHAct’s becoming effective (Public Law 91-596). In 1973, NIOSH recommended that the PEL be lowered to 150 µg/m3. On October 3, 1975, OSHA proposed a new PEL of 100 µg/m3. After the proposal was made, OSHA requested comments, data, and opinions on the lower PEL. Hearings were held in multiple locations in 1977. In light of the information received during the comment period and the hearings, a new lead standard re- ceived final certification on August 8, 1978 (43 Fed. Reg. 52952 [1978]). The OSHA lead standard set the PEL at 50 µg/m3 as an 8-hour TWA, which was technically feasible for industry. In OSHA’s opinion, a lower air lead concentration of 40 µg/m3 would not offer a substantial benefit compared with 50 µg/m3. Action Level An action level is an air concentration that triggers the initiation of re- quired activities, such as exposure monitoring and medical surveillance. OSHA defined the action level for lead as “employee exposure, without regard to the use of respirators, to an airborne concentration of lead of 30 µg/m3 averaged over an 8-hour period” (29 CFR 1910.1025(b)). Exposure monitoring is per- formed to determine whether employees are exposed to lead above the action level. Some requirements are instituted when the action level is exceeded (see the section “Medical Monitoring” below).

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Occupational Standards and Guidelines for Lead 33 Exposure Monitoring The lead standard requires that employers monitor their employees to de- termine their personal exposure to airborne lead. The monitoring must be done for the full work shift of at least 7 continuous hours. It must be done for every shift in which employees were exposed to lead and an evaluation of the data must assume that employees were not wearing respirators. When personal expo- sures are below the action level (30 µg/m3), the result must be documented in writing, and no additional monitoring is required. When personal exposures ex- ceed the action level but are below the PEL, additional personal monitoring is required every 6 months until two consecutive measurements, collected at least 7 days apart, are below the action level. For personal monitoring results above the PEL, additional monitoring must be done quarterly. The sampling frequency can be reduced to every 6 months only when two consecutive measurements, collected at least 7 days apart, are below the PEL (29 CFR 1910.1025(d)). Engineering and Work-Practice Controls Engineering and work-practice controls must be implemented whenever employees are exposed above the PEL for more than 30 days per year. The con- trols include the requirement for a written compliance program to reduce per- sonal exposures to below the PEL. If engineering and work-practice controls do not reduce exposures to below the PEL, respirators must be worn. If mechanical ventilation is used to control exposures, the ventilation system must be evaluated quarterly for its effectiveness in controlling exposures (29 CFR 1910.1025(e)). Respirator Protection and Personal Protective Equipment When respirators are required, a respiratory-protection program must be implemented in accordance with 29 CFR 1910.134. The respirators can be half- mask, full-facepiece, or powered air-purifying respirators. High-efficiency par- ticulate air-equivalent (HEPA-equivalent) filters are required (29 CFR 1910.1025(f)). Personal protective equipment must be provided at no cost to employees when exposures exceed the PEL. The equipment may include face shields, vented goggles, and disposable shoe coverlets. The employer is responsible for cleaning or disposing of the equipment (29 CFR 1910.1025(g)). Housekeeping and Hygiene Facilities and Practices All surfaces must be kept as free as practicable of any accumulations of lead. Surfaces cannot be cleaned by using compressed air; vacuuming is the pre- ferred method of cleaning. When vacuuming is shown not to be effective, shov- eling or dry or wet sweeping may be used (29 CFR 1910.1025(h)).

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34 Potential Health Risks to DOD Firing-Range Personnel When exposures exceed the PEL, an employer must provide dedicated changing rooms, a lunchroom under positive pressure, and shower facilities. Food, beverages, and tobacco products cannot be present, consumed, or used, and cosmetics cannot be applied anywhere in the facility, except in the changing room, lunchroom, or shower areas. Changing rooms must separate street clothes from contaminated work clothing in a way that prevents cross-contamination. Employees are not permitted to enter the lunchroom without removing lead from their protective work clothing. Employees must wash their hands and face be- fore eating, drinking, smoking, or applying cosmetics, and they must shower at the end of each work shift (29 CFR 1910.1025(i)). Medical Monitoring The following are the key points of the OSHA lead standard for general industry regarding medical surveillance (29 CFR 1910.1025(j)):  The employer institutes a medical surveillance program for all employ- ees who are or may be exposed at or above the air action level of 30 µg/m3.  Monitoring is performed by or under the supervision of a licensed phy- sician.  A full medical examination and consultation shall be made available to an employee o Before the first assignment to an area that has lead at or above the action level. o At least once a year for an employee who had a BLL of 40 µg/dL or over at any time during the preceding 12 months. o As soon as possible on notification by an employee that he or she has developed signs or symptoms of lead intoxication, desires medi- cal advice concerning the effects of lead (past or current) and the ability to procreate a healthy child, or who has difficulty in breath- ing during respirator fit test or use.  A full medical examination will include o A detailed work and medical history. o A thorough physical examination. o Measurement of blood pressure. o Analysis of BLL, hemoglobin and hematocrit, erythrocyte indexes, peripheral smear morphology, zinc protophorphyrin (ZPP), blood urea nitrogen and creatinine, urinalysis with microscopic examina- tion, and any other tests that a physician thinks are appropriate, in- cluding a pregnancy test or laboratory evaluation of male fertility if requested by the employee.  Biologic monitoring (for all employees who are working at or above the action level) and medical removal protection: o BLL and ZPP levels evaluated every 6 months.

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Occupational Standards and Guidelines for Lead 35 o BLL and ZPP levels evaluated at least once every 2 months for each employee whose last BLL was 40 µg/dL or higher until two con- secutive BLLs are under 40 µg/dL. o Removal from work of an employee who has a BLL of 60 µg/dL or higher or who has an average BLL of the last three tests (or the av- erage of all BLLs over the preceding 6 months) of 50 µg/dL or higher. o Evaluation of BLL and ZPP levels monthly during medical-removal period. o Removal not needed when the last BLL was under 40 µg/dL. o Temporary removal of an employee who is working at or above the action level and has a medical condition that makes the employee more susceptible to the risk posed by lead.  Medical-removal protection benefits include o Up to 18 months of medical-removal-protection benefits on each oc- casion when an employee is removed. o Employer’s maintenance of earnings, seniority, and other employ- ment rights as though the employee has not been removed. Employee Information and Training Employee training is required whenever there is a potential for exposure to airborne lead. Training must include the information provided in Appendixes A and B of 29 CFR 1910.1025. When employees are exposed above the action level, they must be informed of the content of the lead standard, and a training program must be initiated. Training is required each year, and the employer must make available to all employees a copy of the OSHA lead standard and its appendixes (29 CFR 1910.1025(l)). National Institute for Occupational Safety and Health Criteria NIOSH was created in 1970 by the OSHAct and established in the De- partment of Health Education and Welfare, which became the Department of Health and Human Services, to carry out the duties of the OSHAct assigned to the secretary of health and human services. Those duties include research, ex- periments, and demonstrations related to occupational safety and health (Public Law 91-596). NIOSH first published its Criteria for a Recommended Standard: Occupational Exposure to Inorganic Lead in 1973. After an OSHA proposal to revise the occupational health standard for inorganic lead in 1976, NIOSH re- vised its criteria document in 1978 and lowered its recommended 10-hour TWA for airborne lead from 150 to 100 µg/m3 and its recommended maximum BLL from 80 to 60 µg/dL (NIOSH 1978). NIOSH noted that testimony at OSHA hearings indicated that “based on about 10 studies . . . to keep blood lead levels in male workers below 40

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36 Potential Health Risks to DOD Firing-Range Personnel [µg/dL], air lead exposures have to be kept under 50 µg/m3” (NIOSH 1978, p. XII-14). In addition, data from the General Motors plant in Muncie, Indiana, indicate that “if yearly average personal sampler air lead exposure . . . is kept below 100 µg/m3, yearly average blood leads in over 90% of workers will be under [60 µg/dL]. Similarly, if yearly average personal sampler air leads . . . are kept under 50 µg/m3, yearly average blood leads will be 40 [µg/dL] or lower for over half of the workers. One of the greatest impacts of reducing lead exposure in air from 200 to 100 µg/m3 is a great increase in the number of workers with blood lead levels 40 [µg/dL] or lower” (NIOSH 1978, p. XII-15). NIOSH also notes that the relationship between air lead and BLL may not be linear over the whole range of exposures: “Incremental changes in air lead exposure in the range up to 100 µg/m3 produce greater increases in blood lead than do similar increases in the range from 100-200 µg/m3” (NIOSH 1978, p. XII-115). At the time, the OSHA proposal was for an action level of 50 µg/m3, which NIOSH endorsed in its criteria document “as a future goal to provide greater assurances of safety” (NIOSH 1978, p. XII-19). That air level would keep BLLs at about 40 µg/dL or lower in virtually all workers, protecting against “subclinical” effects of lead. NIOSH also endorsed a “vigorous medical surveillance program” for workers exposed above the action level but below the proposed maximum air lead concentration of 100 µg/m3. NIOSH estimated that “even at the proposed air standard of 100 µg/m3, less than half of the workers will have blood lead levels above 40 [µg/dL]” (NIOSH 1978, p. XII-19). In 1997, NIOSH published a Federal Register notice (62 Fed. Reg. 55407 [1997]) requesting comments and information relevant to the potential health risks associated with occupational exposure to inorganic lead at or below the OSHA PEL of 50 µg/m3. To date, however, no additional recommendations have been proposed by NIOSH. American Conference of Governmental Industrial Hygienists Guidelines ACGIH is a not-for-profit organization with a mission for advancing oc- cupational and environmental health and safety through the development and publication of scientific guidelines and research. The organization manages sev- eral scientific committees that consist of volunteers in government agencies, academic institutions, labor unions, and industrial companies. The committees are the Threshold Limit Values for Chemical Substances Committee, which de- velops TLVs for airborne chemical substances and materials; the Biological Exposure Indices (BEIs®) Committee for biologic indicators of exposure to chemical substances and materials; and the Threshold Limit Values for Physical Agents Committee, which recommends guidelines for physical hazards, such as noise, temperature, and pressure. Each committee recommends exposure guide- lines to the ACGIH Board of Directors, which ensures that all organizational procedures and policies have been followed before ratification. The recommen-

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Occupational Standards and Guidelines for Lead 37 dations of those three committees are published annually in a guide, and written documentation for each TLV and BEI is also prepared. The lead BEI was first proposed by ACGIH in 1985 and adopted in 1987. Levels were set for lead concentrations in blood (50 µg/dL), urinary creatinine (150 µg/g), and ZPP in blood (250 µg/dL for erythrocytes or 100 µg/dL for blood after 1 month of exposure). In 1995, a new BEI BLL was adopted for lead (30 µg/dL); other indicators in urine and blood were dropped. A notation B (background) was included, indicating that “the determinant may be present in biological specimens collected from subjects who have not been occupationally exposed, at a concentration which could affect interpretation of the result. Such background concentrations are incorporated into the BEI value” (ACGIH 2012). In 1998, the B notation was removed “because the U.S. population average blood lead concentration . . . is now less than 3 [µg/dL]” (ACGIH 2001a, p. 8). The goal of the current BEI for lead in blood is to lower the likelihood of several adverse health outcomes, including  Psychologic and psychomotor effects that appear to occur at BLLs over 30 µg/dL.  Changes in nerve conduction and latency intervals that appear to occur at BLLs over 30 µg/dL.  Decrements in hematologic reserve capacity (one study) at BLLs over 40 µg/dL.  Increased blood pressure and incidence of hypertension; effects at BLLs under 30 µg/dL expected to be very small.  Renal impairment with minor effects reported at BLLs under 30 µg/dL and increased proteinuria at BLLs of 40 µg/dL.  Spontaneous abortions and effects on male fertility that appear to occur at BLLs over 30 µg/dL.  Decreased length of gestation and decreased birth weight; expert re- views indicate that effects appear to be associated with BLLs over 30 µg/dL. ACGIH (2001a) notes that some studies have found effects at levels below the BEI, but these were short-lived, did not affect functional capacity, or were contradicted by other studies. The documentation also notes that women and men of childbearing potential who have BLLs over 10 µg/dL may be at risk for having a child who has levels greater than the current guideline from the Centers for Disease Control and Prevention, 10 µg/dL. A TLV 8-hour TWA of 150 µg/m3 for lead and inorganic compounds in air was first adopted in 1946 and has undergone several revisions. The most recent revision in 1995 recommended a TLV-TWA of 50 µg/m3. ACGIH classi- fies lead as a confirmed animal carcinogen with unknown relevance to humans. The TLV-TWA was based on the ACGIH BEI for lead and “intended to mini- mize the potential for adverse health effects that may include blood dyscrasias, reduced nerve conduction velocities, peripheral neuropathies, a possible kidney

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38 Potential Health Risks to DOD Firing-Range Personnel dysfunction, spermatogenesis, impaired intellectual development in children exposed to lead during gestation, and carcinogenicity” (ACGIH 2001b, p. 1). ACGIH notes that “blood values, rather than work environment air lead concen- trations, are most strongly related to health effects. . . . The TLV-TWA is in- tended to maintain worker blood lead levels below the BEI of 30 µg/dL. Main- taining blood levels at or below this level must also focus on control of exposure to non-airborne sources of lead, such as by meticulous plant environment house- keeping, strict personal cleanliness, and prohibition of eating, drinking, and smoking in lead-contaminated areas” (ACGIH 2001b, p. 1). Derivation of the appropriate air lead concentration used the steepest slope (0.19 µg/dL of blood per µg/m3 of air) found in the literature (slopes ranged from 0.03 to 0.19 µg/dL of blood per µg/m3 of air). A TLV-TWA of 50 µg/m3 would be expected to result in a BLL of about 9.5 µg/dL. ACGIH proposes that this air concentration will be sufficient to prevent a BLL of 30 µg/dL (the BEI) if other sources (community or noninhalation workplace exposures) are ade- quately controlled. GUIDELINES OF OTHER COUNTRIES European Council Directive 98/24 The European Council Directive 98/24/EC of 1998 on the protection of the health and safety of workers from risks related to chemicals has “binding occupational exposure limit values” (a maximum allowable TWA of lead in air) and “binding biological limit values and health surveillance measures” (BLLs that should not be exceeded) for lead (Council 1998). The binding occupational exposure limit is 150 µg/m3 (8-hour TWA), and the biologic limit is 70 µg/dL. Medical surveillance is indicated if a worker is exposed to lead at 75 µg/m3 (TWA over a 40-hour week) or if a worker’s BLL is over 40 µg/dL. Taylor et al. (2007) conducted a survey of how the directive has been implemented in 14 EU countries and found disparities in its implementation. Most of the countries have implemented the binding occupational exposure limit for lead, but five countries (Denmark, Finland, France, Germany, and Poland) have set lower limits. Most countries have established binding biologic limits lower than the one specified in the directive, with a range of 20-60 µg/dL. Two countries (Belgium and the Netherlands) allow BLLs as high as 80 µg/dL provided that other measures of biologic effects are below certain limits. Most of the 14 EU countries have adopted the directive’s biologic triggers for medical surveillance. European Union Scientific Committee on Occupational Exposure Limits The European Union Scientific Committee on Occupational Exposure Limits (SCOEL) recommends a lower biologic limit for lead than European

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Occupational Standards and Guidelines for Lead 39 Council Directive 98/24/EC of 1998. The SCOEL recommends a BLL of 30 µg/dL to prevent adverse neurobehavioral effects and signs of male reproductive toxicity that occur at BLLs of 40 µg/dL and higher. The SCOEL could not iden- tify a threshold for impairment of cognitive development in newborns and in- fants and indicated that “exposure of fertile women to lead should . . . be mini- mised” (SCOEL 2002, p. 13). The European Union also has an 8-hour TWA of 100 µg/m3 for inorganic lead, including lead fumes and dusts with particle sizes below 10 µm. The SCOEL documentation conclusion that the carcinogenicity of lead most likely depends on “indirect, rather than on direct genotoxic mechanisms” implies a “practical threshold for the carcinogenic effects, and would argue in favour of the possibility of setting a health-based OEL [occupational exposure limit] for lead” (SCOEL 2002, pp. 8-9). The air lead concentration is considered consis- tent with the biologic limit and was derived from field studies of lead-battery workers by Lai et al. (1997) and others (e.g., Kentner and Fischer 1994). German Commission for the Investigation of Heath Hazards of Chemical Compounds in the Work Area The Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) is in the Deutsche For- schungsgemeinschaft (German Research Foundation), a private organization for science and research. The commission is responsible for determining the current state of research regarding workplace hazardous-chemical health risks and for advising public authorities about these risks. The MAK Commission proposes MAK values (maximum concentrations at the workplace) and BAT values (bio- logic tolerance values) for volatile chemicals and dusts and proposes procedures for analyzing these substances. Each year, the MAK and BAT proposals are presented to the German federal minister of labor and social affairs; these are reviewed by the ministry’s Committee on Hazardous Substances, which deter- mines whether they should be included in the Hazardous Substances Ordinance. The MAK Commission also develops and publishes detailed scientific docu- mentation for each of its MAK and BAT values. From 1977 to 2006, the German MAK for lead and inorganic compounds was 100 µg/m3 (inhalable). The cancer classification was 3B (evidence of car- cinogenicity in animal or in vitro studies without sufficient evidence for classifi- cation in other categories). The BAT, adopted in 2000, was 40 µg/dL in blood, with a pregnancy-risk group B notation (probable risk of damage to embryo or fetus even when the BAT or biologic guideline value [BLW] is observed). Those levels were expected to protect men and women from central nervous system effects, which are first seen at average BLLs of 40 µg/dL, and to prevent cognitive deficits in offspring of exposed women. There was no clear threshold for the latter; effects were expected to be minimal if maternal BLLs were under 30 µg/dL (DFG 2009).

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40 Potential Health Risks to DOD Firing-Range Personnel After a 2006 reclassification of inorganic lead compounds as category 2A carcinogens (probably carcinogenic in humans) by the International Agency for Research on Cancer, a German category 2 cancer notation was assigned to these compounds, and the MAK and BAT were withdrawn. German policy states that “substances carcinogenic in man or experimental animals are classified in cate- gories 1 or 2 and are not assigned MAK or BAT values.” Thus, there is no longer a German MAK for lead, because “it is not possible to derive a no ob- served adverse effect level for the clastogenic effect of lead and its inorganic compounds. . . . Therefore, no threshold value can be established” (DFG 2009, p. 188). A BLW is used when a BAT value cannot be established, as for carcino- genic or suspected carcinogenic substances. The BLW for lead is 40 µg/dL for all men and women older than 45 years old and 10 µg/dL for women younger than 45 years old. The bases for those values are the prevention of neurotoxic effects and minimization of reproductive toxic effects (DFG 2005). Lead and its inorganic compounds are considered to be in pregnancy-risk group B, which indicates probable risk of damage to an embryo or fetus even when the BLW is observed. United Kingdom Health and Safety Executive The Health and Safety Executive (HSE) enforces the Health and Safety at Work Act of 1974, the primary legislation governing occupational health and safety in the UK. The HSE is a nondepartmental public body with Crown status and is accountable to the ministers of the Department for Work and Pensions. The HSE regulates work-related health and safety in the UK in partnership with local authorities; its mission is the prevention of workplace death, injury, and ill health. Within the HSE, the Health and Safety Laboratory is responsible for re- search, scientific, and forensic services, including technical support of investiga- tions. In 2002, the UK HSE issued updated guidance regarding the Control of Lead at Work Regulations (HSE 2002). Workplace exposure to lead is consid- ered significant if levels exceed half the occupational exposure limit of 150 µg/m3 for lead other than lead alkyls, there is substantial risk of ingestion of lead, or there is risk of skin exposure to forms of lead that are readily absorbed through the skin. Significant exposures require protective clothing for employ- ees, air monitoring, and employee medical surveillance. Where engineering con- trols are not feasible or effective, respiratory protection is required. High stan- dards of personal hygiene—including washing facilities and policies that forbid eating, drinking, or smoking in lead-contaminated areas—are required for all employees. The HSE guidance notes that “there is not necessarily a strong relationship between the amount of lead the body absorbs and the concentration of lead-in- air” (p. 8). Medical surveillance is required for those who have significant air lead exposures. If an employee’s BLL exceeds the action level (see below), the

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Occupational Standards and Guidelines for Lead 41 employer must immediately determine the cause, review controls, and take steps to reduce it. If the BLL exceeds the suspension level, the employee should be removed from work. The action levels are a. BLL of 25 µg/dL in women of reproductive capacity. b. BLL of 40 µg/dL in people 16 or 17 years old. c. BLL of 50 µg/dL in any other employee. The suspension levels are a. BLL of 30 µg/dL or urinary lead adjusted for creatinine of 25 µg/g in women of reproductive capacity. b. BLL of 50 µg/dL in young people not of reproductive capacity. c. BLL of 60 µg/dL or urinary lead adjusted for creatinine of 110 µg/g in any other employee. The guidance states that “some employees, excluding women of reproduc- tive capacity, who have worked for many years in the lead industry, may have built up a high body burden of lead which could take a long time to fall below the suspension level of 60 µg/dL” (p. 70). They include employees who “a) have been employed on work which exposed the employee to lead for at least 20 years or b) are aged 40 years or more and may have been employed on work involving exposure to lead for at least 10 years” (p. 70). In those cases, “the em- ployer may take some additional factors into account in deciding whether they should be taken off work involving exposure to lead” (p. 71), including the fol- lowing: 1. Employees who meet either of the above conditions before 2002 may continue to work if BLLs are maintained under 80 µg/dL and ZPP levels are under 20 µg/g of hemoglobin, or ALAD levels are above 6 European units or aminolevulinic acid levels in urine (ALAU) are under 20 mg/g of creatinine. 2. Employees who meet either of the above conditions after 2002 may continue to work if BLLs remain under 70 µg/dL and ZPP levels are under 20 µg/g of hemoglobin, or ALAD levels are above 6 European units or ALAU lev- els are under 20 mg/g of creatinine. It is important to note that the regulation prohibits employment of young persons and women in some tasks in lead smelting and refining and in lead-acid battery manufacturing. EXPOSURE-ASSESSMENT METHODS The committee evaluated the exposure assessment methods used by the Department of Defense (DOD) for air sampling. This section describes the re-

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42 Potential Health Risks to DOD Firing-Range Personnel quirements of the OSHA lead standard and contrasts them with the methods used by DOD. Occupational Safety and Health Administration Requirements The OSHA lead standard (29 CFR 1910.1025) includes requirements for performing monitoring to measure employee exposures and to determine the sources of lead emissions. The standard requires that the monitoring be per- formed without regard to respirators, that is, the protective factor of any worn respirator cannot be used in the determination of the exposure of an employee (43 Fed. Reg. 52925 [1978]). The lead standard requires an initial assessment of lead exposures and re- quires that air sampling be performed or that air sampling performed in the pre- vious 12 months be used to make the initial determination of employee expo- sure. The standard indicates that the air monitoring can be conducted on a sample of the exposed workers who are believed to have the highest exposures. Any additional monitoring is contingent on the findings of the initial assessment. If the results of the initial assessment are negative (airborne concentrations were all below the action level of 30 µg/m3), no further monitoring is required. The results of the initial assessment need to be documented in writing. Further monitoring needs to be conducted only if a change in the process, controls, or personnel could result in an increased exposure to lead. When the initial assessment indicates that personal exposures exceed the action level, additional monitoring is required. If measured exposures are be- tween the action level and the PEL, monitoring must be performed every 6 months. If measured exposures are above the PEL, monitoring must be per- formed quarterly. Quarterly monitoring must continue until at least two sets of consecutive monitoring results are below the PEL. Department of Defense Methods DOD goes beyond the OSHA requirements of assessing the exposures of a sample of the exposed workers who have the highest lead exposures. It has in- corporated the American Industrial Hygiene Association (AIHA®) Exposure Assessment Strategy. The strategy was first published in 1991 in Strategy for Occupational Exposure Assessment. The strategy was updated, and a second edition was published in 1998. The current third edition, A Strategy for Assess- ing and Managing Occupational Exposures, was published in 2006 (Bullock and Ignacio 2006). The purpose of AIHA’s Exposure Assessment Strategy is to protect the health of workers by managing current and future risks with a program that is efficient and effective. The strategy uses a small number of samples (generally six to 10) to determine that worker exposures are acceptable or unacceptable or that more information is needed. The strategy involves placing workers into

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Occupational Standards and Guidelines for Lead 43 similar exposure groups that perform the tasks or jobs in the same manner and therefore are expected to have similar exposures. Monitoring can be performed on the different similar-exposure groups so that acceptability can be judged. The AIHA Exposure Assessment Strategy requires personal exposures to generally be less than 10% of the PEL (or other standard being used) for a judgment of acceptability. The strategy potentially results in lower estimated exposures of workers (Bullock and Ignacio 2006). ADDITIONAL CONSIDERATIONS Creation of the OSHA lead standard for general industry in the late 1970s was an important advance over occupational exposure limits that already ex- isted. The OSHA standard is complex and includes more than the setting of a PEL or an action level. For example, air monitoring will not adequately capture lead exposures that occur via noninhalation routes, which can be important in firing ranges. In particular, ingestion of lead is of concern because of deposition of lead aerosols on hands during shooting or secondary hand contamination after contact with surfaces on which lead aerosols have collected or settled. There are no data that directly link hand or surface contamination levels with specific BLLs, but studies have demonstrated that improved hygiene prac- tices for both employees and the environment can lead to decreasing BLLs. Scott et al. (2012) found that although ventilation is an important method for controlling lead exposures, housekeeping can also have a substantial effect on lead contamination on surfaces in and around a shooting range. Even in ranges that have good ventilation and that use ammunition with lead-free primers, poor housekeeping or failing to decontaminate the range thoroughly before switching primers may adversely affect lead exposures. The Navy Environmental Health Center notes in its Indoor Firing Ranges Industrial Hygiene Technical Guide (NEHC 2002) that although there are no established limits for surface contami- nation in workplaces, OSHA (1993) has indicated in a compliance instruction for the construction industry (CPL 2-2.58) that an acceptable lead loading for nonlead work areas should be 200 µg/ft2. Appendix D of the Navy technical guide suggests clearance standards of 200 µg/ft2 for interior floors and horizon- tal surfaces and 800 µg/ft2 for exterior concrete (the latter is derived from an interim recommendation from the US Department of Housing and Urban Devel- opment). It has been shown that high BLLs can result from lead ingestion during smoking and eating with lead-contaminated hands. Sato and Yano (2006) found that BLLs were substantially higher in battery-recycling employees whose hands showed lead contamination. In a longitudinal study of lead-battery employees in Taiwan, Chuang et al. (1999) found that smoking at work more than 3 days per week increased BLLs by 3.08 µg/dL compared with BLLs in those who had never smoked at work (p < 0.05). Although this is not statistically significant, mean BLLs were 1.32 µg/dL higher in employees who ate at work compared

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44 Potential Health Risks to DOD Firing-Range Personnel with those who did not (p = 0.082). Employees who both smoked more than 3 days per week and ate at work were almost 3 times as likely to have high BLLs than employees who did not. Recent investigations have demonstrated that washing with soap and water is not an effective method for removing lead from skin. Sato and Yano (2006) demonstrated, using sodium sulfide to detect contamination by a change in skin color, that skin-color changes were more likely in lead-battery recycling em- ployees who did not wash their hands or bathe beforehand or who had higher BLLs. Esswein et al. (2011) also developed a colorimetric method capable of detecting lead on skin and workplace surfaces. They demonstrated that hand decontamination, rather than washing, is required to ensure complete removal of lead. They found that a mixture of isostearoamidopropyl morpholine lactate and citric acid applied with a textured absorbent material was almost 100% effective in removing lead from skin. They suggest that the best method for preventing hand-to-mouth exposure may be skin decontamination and a colorimetric method to detect remaining contamination. If DOD’s occupational exposure limit for lead is lowered, surface and skin decontamination are likely to play an even more important role in effective con- trol of employee exposures than in the past. It will be important for an updated guideline to address the importance of decontamination in more detail and with greater precision. Where possible, quantitative levels of contamination should be included in guidelines rather than qualitative statements regarding the impor- tance of housekeeping. REFERENCES ACGIH (American Conference of Governmental Industrial Hygienists). 2001a. Lead, Elemental and Inorganic. Documentation of the Biological Exposure Indices-BEI®, 7th Ed. American Conference of Governmental Industrial Hygienists, Cincinnati, OH. ACGIH (American Conference of Governmental Industrial Hygienists). 2001b. Lead and Inorganic Compounds. Documentation of TLV® Chemical Substances, 7th Ed. American Conference of Governmental Industrial Hygienists, Cincinnati, OH. ACGIH (American Conference of Governmental Industrial Hygienists). 2012. 2012 TLVs® and BEIs®. American Conference of Governmental Industrial Hygienists, Cincinnati, OH. Bullock, W.H., and J.S. Ignacio, eds. 2006. A Strategy for Assessing and Managing Oc- cupational Exposures. Fairfax, VA: AIHA Press. CalOSHA (California Division of Occupational Safety and Health). 2003. Cal/OSHA Gen- eral Industry Safety Orders, Lead Section 5198, Amended June 19. 2003 [online]. Available: http://www.cdph.ca.gov/programs/olppp/Documents/ligi.pdf [accessed June 26, 2012]. Chuang, H.Y., M.L. Lee, K.Y Chao, J.D. Wang, and H. Hu. 1999. Relationship of blood lead levels to personal hygiene in lead battery workers: Taiwan, 1991-1997. Am. J. Ind. Med. 35(6):595-603.

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Occupational Standards and Guidelines for Lead 45 Council (Council of the European Union). 1998. Council Directive 98/24/EC of April 7, 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work. OJEC 131:11-23 [online]. Available: http://eur-lex.europa.eu/LexUri Serv/LexUriServ.do?uri=OJ:L:1998:131:0011:0023:EN:PDF [accessed Nov. 27, 2012]. DFG (Deutsche Forschungsgemeinschaft). 2005. Lead and its inorganic compounds (except lead arsenate, lead chromate and alkylated compounds). The MAK Collection for Occupational Health and Safety, Part II. BAT Value Documentations, Vol. 4, H. Drexler, and H. Graim, eds. Weinheim, Federal Republic of Germany: Wiley VCH [online]. Available: http://onlinelibrary.wiley.com/book/10.1002/3527600418/topics ?filter=mbe743992 [accessed Apr. 19, 2012]. DFG (Deutsche Forschungsgemeinschaft). 2009. Lead and its inorganic compounds (inhal- able fraction). Pp. 165-192 in The MAK-Collection for Occupational Health and Safety, Part I. MAK Value Documentations, Vol. 25, H. Greim, ed. Weinheim, Fed- eral Republic of Germany: Wiley VCH [online]. Available: http://onlinelibrary. wiley.com/book/10.1002/3527600418/topics?filter=mbe743992 [accessed Apr. 19, 2012]. Esswein, E.J., M.F. Boeniger, and K. Ashley. 2011. Handwipe method for removing lead from skin. J. ASTM Int. 8(5):1-10. HSE (Health and Safety Executive). 2002. Control of Lead at Work, 3rd Ed. U.K. Health and Safety Executive [online]. Available: http://www.hseni.gov.uk/l132_control _of_lead_at_work.pdf [accessed June 26, 2012]. Kentner, M., and T. Fischer. 1994. Lead exposure in starter battery production: Investiga- tion of the correlation between air lead and blood lead levels. Int. Arch. Occup. Environ. Health 66(4):223-228. Lai, J.S., T.N. Wu, S.H. Liou, C.Y. Shen, C.F. Guu, K.N. Ko, H.Y. Chi, and P.Y. Chang. 1997. A study of the relationship between ambient lead and blood lead among lead battery workers. Int. Arch. Occup. Environ. Health 69(4):295-300. NEHC (Navy Environmental Health Center). 2002. Indoor Firing Ranges Industrial Hy- giene Technical Guide. Technical Manual HEHC-TM6290.99-10 Rev. 1. Navy Environmental Health Center, Bureau of Medicine and Surgery. May 2002 [online]. Available: http://www.nmcphc.med.navy.mil/downloads/IH/indoor_firing _range.pdf [accessed Dec. 19, 2011]. NIOSH (National Institute for Occupational Safety and Health). 1978. Criteria for a Rec- ommended Standard: Occupational Exposure to Inorganic Lead, Revised Criteria – 1978. DHEW (NIOSH) No. 78-158. U.S. Department of Health, Education, and Welfare, Public Health Service, Center for Disease Control, National Institute for Occupational Safety and Health [online]. Available: http://www.cdc.gov/niosh/ docs/1970/78-158.html [accessed Mar. 27, 2012]. OSHA (Occupational Safety and Health Administration). 1993. 29 CFR 1926.62, Lead Exposure In Construction; Interim Final Rule--Inspection and Compliance Proce- dures. OSHA Instruction CPL 2-2.58, December 13, 1993. Occupational Safety and Health Administration, Office of Health Compliance Assistance [online]. Available: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=1570 &p_table=DIRECTIVES [accessed Nov. 28, 2012]. Sato, M., and E. Yano. 2006. The association between lead contamination on the hand and blood lead concentration: A workplace application of the sodium sulphide (Na2S) test. Sci. Total Environ. 363(1-3):107-113. SCOEL (Scientific Committee on Occupational Exposure Limits). 2002. Recommendations from the Scientific Committee on Occupational Exposure Limits for Lead and its In- organic Compounds. SCOEL/SUM/83. European Commission, Employment, Social

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46 Potential Health Risks to DOD Firing-Range Personnel Affairs and Inclusion [online]. Available: http://ec.europa.eu/social/main.jsp?langId =en&catId=22 [accessed Apr. 19, 2012]. Scott, E.E., N. Pavelchak, and R. DePersis. 2012. Impact of housekeeping on lead expo- sure in indoor law enforcement shooting ranges. J. Occup. Environ. Hyg. 9(3): D45-D51. Taylor, A., J. Angerer, J. Arnaud, F. Claeys, J. Kristiansen, O. Mazarrasa, A. Menditto, M. Patriarca, A. Pineau, S. Balkonen, and C. Weykamp. 2007. Differences in na- tional legislation for the implementation of lead regulations included in the Euro- pean directive for the protection of the health and safety of workers with occupa- tional exposure to chemical agents (98/24/EC). Int. Arch. Occup. Environ. Health 80(3):254-264.