Document 446xe2z0bOJooXZ00qjopBDx

OCCUPATIONAL SAFETY & HEALTH REPORTER A weekly review of occupational safety and health developments Volume 7, Number 38 THE BUREAU OF NATIONAL AFFAIRS, INC. February 16, 1978 Part II OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION PREAMBLE TO RULE REGULATING EXPOSURE TO BENZENE [43 FR 5918, February 10, 1978] HO* 29--Labor CHAPTER XVIt--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OP LABOR PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS Occupational Ezpoiura to Banzano AGENCY: The Occupational Safety and Health Administration, Depart ment of Labor. ACTION: Permanent standard for the regulation of benzene. SUMMARY: This standard is based on a determination by the Occupational Safety and Health Administration (OSHA) that the available scientific evidence establishes that employee ex posure to benzene presents a cancer hazard--specifically, the hazard of de veloping leukemia. Therefore, in ac cordance with OSHA's regulatory ap proach to the control of employee ex posure to carcinogens, this standard limits employee exposure to benzene to the lowest feasible level. In this case 1 part benzene per million parts of air (1 ppm) as an 8 hour time--weighted average concentration, with a ceiling level of 5 ppm for any IS minute period during the 8 hour day. The standard also prescribes limits on eye and skin contact with benzene. The standard provides for the mea surement of employee exposure, engi neering controls, work practices, per sonal protective clothing and equip ment. signs and labels, employee train ing. dical surveillance and record keeping. EFFECTIVE DATE: March 13, 1978. FOR FURTHER INFORMATION CONTACT: Mr. Gail Brlnkerhoff, Office of Com pliance Programs. OSHA, Third Street and Cor.jtitution Avenue NW,, Room N3112, Washington, D.C. 20210. telephone 202-523-8034. SUPPLEMENTARY INFORMATION: This permanent Occupational Safety and Health standard is issued pursu ant to sections 6(b), 6(c) and 8(c) of the Occupational Safety and Health Act of 1970 (the Act) (84 Stat. 1593, 1596. 1599: 29 U.S.C. 655. 657), the Sec retary of Labor's Order No. 8-76 (41 FR 25059) and 29 CFR Part 1911. The new standard on occupational expo sure to benzene which appears at 29 CFR 1910.1028. applies to all employ ment in all industries covered by the Act. For reasons set out below, the standard does not apply to the distri bution or use of gasoline and other fuels, used as fuels, subsequent to dis charge from bulk terminals. Moreover, the standard applies labelling and training requirements only to sealed. Intact containers of benzene. This document also amends Table z2 of 29 CFR 1910.1000 by adding a footnote which provides that benzene exposures not covered by the new 1910.1028 are still covered by the ex posure level and other requirements of 1910.1000. Pursuant to section 4(b)(2) of the Act, OSHA has determined that this standard is more effective than corresponding standards now applica ble to the maritime and construction industries and currently contained in Subpart B of Pert 1910, and Parts 1915, 1916, 1917, 1918 and 1926 of Title 29, Code of Federal Regulations. Therefore, those corresponding stan dards are superseded by the new stan dards in 5 1910.1028. A new paragraph (c) is added to 1910.19 to clarify the applicability of this new benzene stan dard to the construction and maritime industries. I. Background Benzene (C2H6) Is a clf-ar, colorless, non-corrosive, highly flammable liquid with a strong, rather pleasant odor. Benzene's low boiling point and high vapor pressure cause it to evaporate rapidly under ordinary atmospheric conditions, giving off vapors nearly three times heavier than air. Benzene is produced primarily by the petrochemical and petroleum re fining industries by a process called catalytic reformation, which converts certain lower octane hydrocarbons Into higher octane aromatics. These two industries are responsible for 94 percent of the total U.S. production of benzene. Recovery through catalytic reformation, including the benzene formed from the hydroalkylation of toluene, accounts for almost 80 per cent of the total quantity produced. Recovery of coal-derived benzene, pri marily as a by-product of the coking process in steel mills, was once the major source of benzene. Today, how ever, it accounts for only 6 percent of the total U.S. production. The production of benzene is rapidly expanding with approximately 11 bil lion pounds produced in 1976. Only eleven other chemicals and only one other hydrocarbon (ethylene) are pro duced in greater tonnage in the U.S. Approximately 86 percent of this ben zene is used chiefly as an intermediate in the production of other organic chemicals, including styrene, phenol, and cyclohexane. The remaining amount is used primarily in the manu facture of detergents, pesticides, sol vents and paint removers. Benzene is also present as a component of motor fuels, averaging less than 2 percent in gasoline. The first major industrial use of} benzene, however, was as a solvent in the rubber industry' Just preceding World War I. During World War I. benzene production was stimulated gre:'.-1'.' bv ' rd for and result ing ox toluene in uie manu facture of explosives. The large quan tities of benzene which were produced, resulted in its more widespread use as a starting point for the manufacture of various organic compounds. This situation led to greatly increased uses MCD 000019232 Section la Published by THE BUREAU OF NATIONAL AFFAIRS, INC.. WASHINGTON, D-C- 20037 CURRENT REPORT 1405 whereas the retrospective method de display overt physical symptoms. tects overt and fatal toxic effects sub Anemia results in a decreased capacity sequent to termination of employ of the blood to transport oxygen to ment. various parts of the body, and persons OSHA is aware of the vanring qual so diagnosed may appear pale and ity of the individually reported stud weak and fatigue easily. However, the ies. Based on a review of the entire set non-specific symptoms may develop of studies, taken as a whole, the accu gradually and not require medical at mulated evidence Is conclusive that tention-until there are significant de benzene exposure is causally related to clines In red cell counts and blood he the Induction of leukemia (a cancer of moglobins. Chronic anemia may also the blood-forming system), various cy- result In physiological adjustments by topenias (decreased levels of a formed the cardiovascular system and exacer element In the circulating blood), bate difficulties in those with coexist aplastic anemia (a non-functioning ing disease such as coronary Insuffi bone marrow) and to development of chromosomal aberrations. The evidence supportive of this con clusion is derived from: (a) A high degree of association of blood dyscrasias with benzene exposure; (b) the ap parent lack of & similar association with other known volatile chemicals In the same workplace; (c) outbreaks of hematotoxiclty temporarily related to the Introduction of benzene to an In ciency or chronic obstructive broncho pulmonary disease (Wlntrobe, Ex 2A107. p. 532). Since white cells provide a defense against many diseases, persons with leukopenia are prone to recurrent infections. Goldstein has written that "Infections are a dreaded complication of bone marrow toxicity and not un commonly associated with a cause of death In benzene-induced pancyto penia"1 (Ex 43B. p. 144). Thrombocy topenia results In an impaired clotting dustry and conversely. & reduction In Of the blood, and persons with this dis blood-related disease when other sol order may exhibit bleeding tendencies, vents are substituted for benzene: and such as easy bruising, nosebleeds, and (d) the experimental demonstration of hemorrhage. marrow toxicity in animals solely ex posed to benzene (Goldstein, Ex. 43B, p. 133). The following studies are. represen tative. although by no means all Inclu In the NYU review of "A Critical Evalua tion of Benzene Toxicity". Goldstein uses the term pancytopenia in a general sense, defined as a decrease In the level of circula sive, of the published literature on the tory erythrocytes, granulocytes, and plate chronic effects of benzene exposure. lets. His rationale is that there Is excellent These investigations do, however, il lustrate the diversity and variability of the effects which dominate published reports. There are also several recent reviews and summaries concerning the hematological effects resulting from evidence which suggests that all of thesa cell lines originate from a common precur sor stem cell (Exhibit 43B. p. 135). While noting that aplastic anemia is. In a pure sense, an absence or a decrease in Identifi able granulocyte, erythrocyte, and platelet precursors within the marrow itself. Oold- benzene exposure (See: Vigilani and Foml, Ex. 2-15; National Research Council, Ex. 2-4; NIOSH, Ex. 2-3, 2-5; NYU report; Ex. 43.B and ORC/Jandl. P.C. 34; Snyder and Rocsls. Ex. 23288, and the International Workshop on the Toxicology of Benzene ("Inter national Workshop") (Ex. 18). stein finds that it Is useful to Include aplas tic anemia or hypoplastic anemia under the category of pancytopenia. This is because In some human cases of pancytopenia induced by benzene and in some experi ments. a hyperplasia of the bone marrow is observed: also there exists the possibllty .*** sampling errors may affect attempts to quantitate bone marrow precursor cells, 2. Non-Maliffnant Blood Disorders. since only a small fraction of the marrow is observed by aspiration techniques. a. Human studies. The most However. Jandl feels that aplastic anemia common effect resulting from chronic Is not a sufficiently explicit term to describe exposure to benzene is a decrease in failure of "marrow to provide an adequate the levels of erythrocytes (red blood population of dividing blood cells for the 3 cells), leukocytes (white blood cells) series of formed elements," and observes and thrombocytes (platelets) in the circulating blood. In simplified terms, a decline in red cells is termed anemia, a decrease In the level of white cells Is leukopenia and a decline in the plate that the terminology "aplastic anemia" has been applied to states of chronic or nonacute marrow suppression, whether or not anemia was the moat striking feature (ORC/Jandl PC 34. p. 83. Add. 3C). Other terms used synonymously have been "hypo let count is called thrombocytopenia. plastic anemia, bone marrow failure, refrac Persons found to have depressed blood tory anemia and aregeneratlve anemia." cell counts'may or may not depending. Based on the degree of severity exhibited, In part on the severity of the decline. Jandl recognizes 2 phases of marrow failure: Pancytopenia and aplastic anemia are more serious conditions In which all 3 formed elements are depressed. These non-cancerous diseases may. In and of themselves, be fatal. An addi tional concern Is that some or all of these disorders induced by benzene, may. If allowed to continue, either pro gress to or represent a preleukemia stage which may eventually evolve Into a frank leukemia. Among the early studies describing benzene toxicity was that of Selling (Ex 2-12). He observed a significant depression in the levels of circulating blood cells In workers employed where benzene was used as a solvent for rubber. Because of the depressed con dition seen In- the marrow of his pa tients and the results of extensive animal experiments (where he was able to produce both destructive and "regenerative'' effects by subcuteneous injection of benzene), Selling sug gested that the cause of the cytopenias observed In the workers was due to an aplasia of the marrow. An Important early milestone of the benzene literature was the 1922 report by Hamilton entitled "The Growing Menace of Benzene (Benzol) Polsioning In American Industry" (Ex 159.0. The document attempted to alert the medical community to the dangers associated with chronic benzene poi soning which was less well known than acute toxicity. This was followed sev eral years later by the reports of the National Safety Council (NSC) which reported the prevalence of known cases by chronic benzene poisoning. These results are summarized by Jandl as follows: The magnitude of toxicity--primarily consiting of lowered blood cell counts--was "(Bly convention, a diminution in the level of all blood cells produced In the marrow accompanied by evidence that bone marrow celluiarlty is deficient, but from which recovery occurs, usually, termed `pan cytopenia.' And by convention, a more sus tained. more severe, more likely fatal sup pression of the marrow is.termed `aplastic anemia.' " (P.C. 26B. P. 83. Add. 3U)>. OSHA recognizes the usefulness and the technical reasons for Jandl's establishment of quantitative diagnostic criteria for var ious non-m&llgnant- blood disorders and his "reassignment" of diagnoses contained in the literature according to this classification scheme. However, for convenience sake, the terms "pancytopenia" and "aplastic anemia" are used interchangeably through out the preamble except when discussing 'art'c-lar points contained Ln Jandl's review. In these instances, the term..- Jlogy will reflect Jandl's more definitive nomen clature. Published by THE Of REA U OF NATIONAL AFFAIRS. INC., WA '>111`' F,TON . D.C. 2C037 CURRENT REPORT 1409 noted that these submissions were characterized by the American Iron and Steel Institute as largely " anecdotal in nature" (Ex. 36, p. 64). In further support of its position. Indus try cites the 1974 NIOSH criteria doc ument recommendation that a 10 ppm TWA as a "conservative limit" (Ex. 22. p. 73). It is clear, there is no dispute that bone marrow toxicity can result from exposure to benzene above 25-40 ppm range. Furthermore, it is recognized that higher dosages produce increased response and that lower dosages are associated with reduced response. It is not clear, what adverse health effects occur below 20 ppm. There are suggestions of hematologi cal alterations (other than chromoso mal aberrations) at concentrations below 25 ppm. Pagnotto et al. Indicat ed that such effects occurred among workers employed in rubber coating Industy exposed to concentrations for the most part between 6 and 25 ppm benzene (Ex 2A-116; Tr. pp. 360-361). Horiguchi has reported small changes In leukocyte function concentrations as low as 10 ppm, in the absence of any marrow change and with only slight variations in leukocyte count and leukocyt phagocytic activity among workers exposed to benzene in concentrations of 0.8-6 ppm (Ex 2A161, p. 7). And there are also other re ports ' 1 less apparent effects at air borne levels of 6-16 ppm in workers who do not exhibit characteristic he matological abnormalities. (Kahn and Muzyka, Ex 2A-260). It Is not possible at this time to establish with any con fidence a consistent dose-response re lationship between benzene exposure and adverse health effects. Where exposure information is avail able, it Is generally area sampling and not personal exposure data that is re ported. It is difficult to determine indi vidual worker exposure based on area sampling. Compounding this difficulty are problems related to the fluctuat ing character of occupational expo sure; the small amount of long-term data; and the fact that in small popu lations, workers with heightened sensi tivity may not be encountered. ^At lower exposure levels, there is a pauci ty of data to provide a basis for defini tive conclusions as to the extent of nonmallgnant effects. In this regard Battle states that: CElven a cursory study of the literature reveals a distressing lack of exposure-hema tologic effect data pai.lcularly in the low benzene exposure area of less than 10 parts per million. (PC 26C, p. 2). Moreover, the absence of pre-expo sure hematological values for com parative purposes limits the usefulness IV Leukemia A. DEFINITION AND DESCRIPTION OF THE of the few studies and reports which DISEASE are available, because we cannot tell whether a particular worker studied with blood values at either extreme of the normal range is suffering adverse effects. Therefore, the available litera ture is insufficient to permit construc tion of dose-effect curve. Robbins defines leukemia as: Leukemia may best be considered as a neoplasm (cancer) of the white blood cells and is so classified in the International Lists of Causes of Death. It Is characterized chief ly by: The appearance of abnormal, imma ture white cells in the circulating blood; dif As indicated above, the quality of evidence available In the record is con sidered Insufficient to permit mean fuse and almost total replacement of the bone marrow with the leukemic cells; and widespread Infiltrates of the liver, spleen, and other tissues, analogous to metastatic ingful conclusions concerning expo dissemination of solid tissue cancer. (Ex. 2- sure to benzene at low levels and re 24. p. 723). sulting health effects. Industry par ticipants have cited the 10 ppm level Once leukemia is diagnosed there is virtually no chance of recovery. There established by the ACGIH as evidence that this level can be considered safe. However, in establishing TLV's, are different categories of leukemia, depending on the duration of the dis ease. I.E., acute or chronic; an increase ACGIH recognizes that for some work or non-increase in the number of ab ers,harmful health effects may result normal cells, l.e,, leukemia or aleuke from exposure to the toxic substance mia: and the cell type involved, i.e., at levels below the TLV. Therefore, myelord, monocytic or lymphoid. the 10 ppm TLV for benzene is recog nized by ACGIH as a level which does Goldstein also emphasizes that, "there are other differences between various not protect all workers from material subtypes of leukemia in terms of inci impairment of health. dence, clinical course, prognosis and Leukemia aside, with benzene we are dealing with an etiological agent welldocumented to produce a variety of blood abnormalities, some of which are fatal. OSHA Is aware of several studies reporting blood abnormalities at levels below 25 ppm. at levels per haps as low as 10 ppm. Because of these considerations, and the wide range of human sensitivity to benzene, presumably etiological mechanism" (Ex 43B, p. 156). The most prevalent subtype of leu kemia in adults, and the type most commonly associated with benzene Is acute myelogenous leukemia (AML). This disease is variously known as acute myeloid leukemia, acute granu locytic leukemia, and acute myeloblastic leukemia (ORC/Jandl. PC 34). OSHA cannot determine a minimum There are several variants of AML, effect level for benzene and, further probably related to the pluripotential more, cannot conclude that 10 ppm of the precursor cell and include provides sufficient protection against erythroleukemia, (DiGuglielmo's Syn non-neoplastic effects to all workers. drome) and acute monocytic leukemia OSHA recognizes that prudent public (myelomonocytic, or monomyelocytic). health policy, and established toxico (ORC/Jandl. PC 34. p. 71). logical principles necessitates setting Despite advances In leukemia ther the permissible exposure limit suffi apy and the fact that half the adults ciently below the levels at which ad diagnosed with AML enter Into a re verse effects have been observed to mission (generally averaging 6 to 8 assure adequate protection for all ex months) the prognosis of this disease posed employees. It is customary to remains poor (ORC/Jandl, P.C. 34, p. use a safety factor of 10-100 or greater 73). Those who enter into remission depending on the seriousness nf the have life expectancies averaging from toxic effects and the nature of the 12 to 18 months, and those who fail to data being relied upon. That is. the respond to therapy have a 50 percent lowest levels at which effects had been survival rate of only 3 to 6 months. observed would be reduced by the Aksoy noted that in his experience, safety factor chosen in establishing for cases of benzene-induced leuke the exposure limit. Taking this ap mias, the period of survival after dis proach in the case of ber.jene would covery was short, usually less than 6 lead to a permissible exposure sub months (Tr-275). stantially less than 10 ppm without Myeloproliferative disc-ders, includ regard to the issue of leukemia and ing chronic myelogenous leukemia the view that no safe level can be es (CML) have only occasionally been at tablished for the carcinogenic risk. tributed to benzene. Lymphocytic leu- 0^9 00 Published hy THE BOREAL' OK NATIONAL AKKAIRS, INC.. WASHINGTON, D C. 200J7 CURRENT REPORT 1413 the findings of many studies that However, as Blckmore stated: there is an excess leukemia risk among benzene exposed employees. Allied Chemical Corp. submitted a post-hearing comment containing mor * In all 35. the expected, the incident (SIC) of mortality and expectation Is so low as to preclude any meaningful statistical calculations by the professionals that made tality data for employees with poten the study. iTr. 3314) tial benzene exposure (P.C. 22). Death certificates were obtained for all work ers dying between 1961 and mid-1977. Rough exposure Information was de rived by back extrapolation. limited exposure data, and subjective reports of employees regarding signs and symptoms. Based on these estimates of benzene exposure, there was no ob served cluster of leukemia in oper ations having benzene exposure. Be cause this study was presented to These coke oven worker studies were designed to assess worker risk of expo sure to coke oven emissions (Ex. 113 p. 1) (P.C. 27C p. 1, P.C. 27D p. 1). Given the small numbers of observed and ex pected rates of leukemia, and In the absence of a study designed to assess coke oven worker exposure to benzene. OSHA believes it Inappropriate to rely on these studies as evidence that there is not a leukemia risk of exposure to OSHA after the hearing closed, more specific details concerning the esti mate of exposure, the method utilized benzene. During the hearing, Stallones dis cussed the unpublished study of 3,600 for obtaining estimates of person- Shell OH Company workers with po years at risk, or how the death certifi tential" benzene exposure (Ex. cates were coded were not obtained. 115C.2). Among this population he tes In 1974, Thorpe reported that the tified that he observed no excessive incidence of leukemia, among a popu leukemia mortality in the three year lation of 38,000 workers exposed to period ending In 1976. Stallones could low levels of benzene over a ten year not determine how many workers were period <1962-1972), was not statistical- exposed to benzene. In fact, clerks and ly different from that expected on the officer workers were Included in the basis of the general population (Ex. 2- study group. Again, failure to correct 34). However, the study has been criti ly Identify or define a benzene-ex- cized for the relaxed casefinding tech posed cohort limits the usefulness of niques and analytical methods this study. (Brown, Ex. 2A-35). Thorpe himself A series of published and unpub acknowledged the following serious lished epidemiologic studies investigat methodologic deficiencies: ing the mortality experience of rubber workers have been entered into Che 1. Validity of leukemic diagnoses. hearing record. (McMlchaels et al. Ex. 2. Quantitative determination of exposure levels. 3. Adequacy of retiree follow-up. 4. Complete occupational histories. 2-36, -37, 2B-295): Monsan and Nakano (Ex. 2-83); Fox et al. (Ex. 261); Andjelkovic (Ex. 2-54); Occupa tional Health Studies Group, UNC As In the case of the Tabershaw/ (Ex. 187.B). These studies have, in Cooper study, OSHA cannot separate general, shown 'excess of lymphoma the benzene-exposed workers from and leukemia among rubber workers. those with little or no exposure. This The leukemia was predominantly lym difficulty, compounded by the 4 defi phatic, a cell type not commonly asso ciencies listed above, also precludes re ciated with benzene. The proportion liance upon the finding of the Thorpe of rubber workers actually exposed to study. benzene in these studies Is undeter University of Pittsburgh Investiga mined. The presence of other chemical tors (Lloyd, Redmond, Ex. 113) have exposures raises the question of an al published a notable series of epidemi ternative causative agent for the ological studies of steelworkers mortal excess of lymphatic leukemia and lym ity. AlSr (P.C. 36, pp. 59-60) cited the phoma observed among rubber work above studies as evidence of no leuke ers. In view of these considerations, mia risk among benzene-exposed coke these studies provide no additional evi oven workers. Most notably, the incfus- dence for the leukemogenic potential try cited the fact that byproduct plant of benzene. coke oven workers were not found to have been at excess risk (P.C. 36. p. 60) and recommended that coke ovens be excluded from the benzene standard (P.C. 36, p. 100). There has been discussion whether benzene is a primary carcinogen (can directly effect a neoplastic alteration without host-mediated activation); a secondary carcinogen (chemicals which may increase susceptibility of cells, to a primary carcinogen); a procarcinogen (requires biochemical al teration prior to effect); or a co-carcinogen (which requires the Interac tion of another chemical to elicit a neoplastic response). (Olson. Tr. 2892: NRC, Ex. 2-4, p. ii; API/NFRA Brief, P.C. 33. p. 86-87; Aksoy. Tr. 177; Furst, Tr. 1744; Stockinger; P.C. 32-H. 53); Welsburger. P.C, 32-1; Tabershaw Tr. 2549, 2545). The evidence is. at pre sent. insufficient to choose among these alternatives. Namely, what is ap parent. however, is the effect of ben zene exposure--a significantly in creased risk of death from leukemia. Types of leukemia clearly associated with benzene exposure include acute myelogenous leukemia (AML) and its variants. For example, Aksoy testified that among 40 cases of leukemia among benzene-exposed workers in Turkey, AML and its variants were the most frequently observed form (Ex. 60, p. 7). In the experience of Vlgliani and his coworkers, only acute or suba cute myelogenous leukemias were ob served (Ex. 2-49). The predominant cell type found by Infante (Ex. 2A271) and others were also myelogenous in character. This well-established as sociation between benzene and AML is in concert with the well-known toxic effects of benzene on bone marrow stem cells (Goldstein, Ex. 43B, p. 162). In contrast to the definitive relation ship between benzene and the induc tion of AML and Its variants, there is considerable scientific debate concern ing the association between benzene exposure and the development of chronic forms of leukemia (CLL and ML). Jandl has stated that "* a lymphoid leukemia is not a feature of benzene toxicity." (ORC/Jandl, P.C. 34. p. 59), and Lamm ruled out chronic leukemia, not as a "possibility", but as a "probability" (Tr. 2558). Aksoy found no cases of CML among the workers he studied. (Ex. 60, p. 6-F), and no cases of CLL were seen by the Italian investigators. A different result has been reported by several French studies which have reported a relative ly high incidence of CLL. In some In stances, there were more cases of CLL than AML. They also report a higher incidence of CML than would be ex pected based on Aksoy's and Vigllani's findings. Supporting the high inci dence of CLL In the French studies is tiie ..,jrt by i.,rreef which describes OOO^' 0 by THK I1UHKAU Of' NATIONAL A L 1 A IKS, INC-. W Abl 11 N C. TON, 0 C. 2'JO 17 CURRENT REPORT 1417 lationship of benzene to the induction of leukemia. Although these studies, for the most part involve high expo sure levels, it is OSHA's view that once the carcinogenicity of a substance has been established qualitatively, any ex posure must be considered to be at tended by risk when considering any given population. OSHA therefore be lieves that occupational exposure to benzene at low levels poses a carcino genic risk to workers. The Agency, however, recognizes that not all indi viduals exposed to benzene will suffer harmful effects. The benzene record establishes that there may be individ ual effect levels. However, there is no way of ascertaining which workers in any exposed population are suscepti ble and to what levels. OSHA further recognizes that deter minations of carcinogenicity are nor mally based on animal studies, and when available, human evidence. OSHA acknowledges that, at the pre sent time, there is no unequivocal animal model demonstrating the in duction of leukemia. However, the lack of an animal model does not di minish the conclusive nature of human evidence demonstrating ben zene's leukemogenicity. OSHA acknowledges that there are many unresolved issues concerning the relationship between benzene expo sure and leukemia: Whether benzene is a co-carcinogen, a procarcinogen, etc. Whether benzene exposure is causally re lated to Induction of forms of leukemia other than AML and its variants. Whether blood dyscrasias, such as aplastic anemia always precede benzene leukemia. To what extent are leukemia deaths at tributable to occupational exposure to ben zene. What factors identify a sensitive popula tion. These questions are on the frontier of scientific and medical knowledge and. given the mandate of the Act. OSHA cannot wait for answers while workers are exposed to this life-threatening substance. There is no doubt that ben zene is a carcinogen and must, for the protection and safety of workers, be regulated as such. Given the Inability to demonstrate a threshold or estab lish a safe level, it is appropriate that OSHA prescribe that the permissible exposure to benzene be reduced to the lowest level feasible. 4. Chromosome studies. OSHA has examined both the original literature of benzene-induced chromosomal changes and the material contained in recent reviews of the subject (NRC Report, Ex. 2-4, section entitled: Chro mosome Effects; Foml, Ex. 156.H and; Wolman. NYU Report Ex. 43.B. Chap ter VI). Evidence derived from human studies together with similar results obtained from experimental investiga tion clearly demonstrates that ben zene can induce visible damage to chromosomes in lymphocytes and blood-forming cells. For example, Tyroler noted that: "I think there is rather convincing evidence that the chromosomal aberrations are associat ed with exposure to benzene." (Tyroler. Tr. 3100; also see International Workshop, Ex. 17. p. 6). The effects may be manifested as numerical alter ations and/or structural rearrange ments of the chromosomal material and include additions or deletions of chromosomes, segments of whole chro mosomes or chromosome sets. In addi tion to exchanges which result In mor phologically aberrant chromosomes (Wolman. NYU Report. Ex. 43.B, p.--). Foml has observed that the aberra tions produced by benzene exposure are non-specific and are similar to those produced by ionizing radiation. (Ex. 156.H). To what extent these events are detrimental to human health is not known. a. HUMAN STUDIES There are numerous reports on chro mosomal evaluations In worker popu lations both with and without clinical symptomatology resulting from expo sure. In general, these studies reveal that there are statistically significant increases in chromosomal damage In those occupationally exposed to ben zene. The chromosome alterations have been classified as either unstable changes (l.e., fragments, dicentric, trlcentric and ring chromosomes) and stable changes (i.e. abnormal monocentric chromosomes due to deletions, translocations, inversions and triso* mies). Aneuploldy (abnormal chromo some number) and/or polyploidy (a multiple chromosomal set) have also been observed. The early reports fo cused on the examination of workera exhibiting benzene hemopathy (a dis ease of the blood). As early as 1964 Pollinl and Columbf published such a study. (Ex. 2-17). Examination of cul tured bone marrow cells and peripher al lymphocytes showed increased fre quencies of aneuploid cells and struc tural aberrations. A second study by the same group (Ex. 2-4, reference 50) of 4 patients with temporary or pro gressive blood dyscrasias revealed that the Incidence of heteroplold (abnor mal number) chromosomal patterns ranged around 70% both in the blood and in the marrow of each subject. The authors were, however, unable to establish a correlation between the du ration and degree of exposure and either the frequency of chromosome aberration or the degree of toxicity. Othy cytogenetic studies of subjects with benzene-related hemopathies have yielded similar findings (e.g. Fomi and Moreo, Ex. 2-18 and 2-19, Sellyei and Keleman, Ex. 2A-258; Aksoy et al.. Ex. 2-57; and Erdogan and Aksoy. Ex. 2A-192). Variables which make these case reports diffi cult to interpret and compare include: differential diagnoses, the use of lym phocytes artifically stimulated to grow in some cases and bone marrow ceils in others; the occasional lack of "normal" baseline chromosomal breakage frequency; and the occur rence in some cases of pre-existing fa milial chromosome aberrations (Wolman, Ex. 43-B, p. 129). In spite of the limitations of these reports, Wolman has stated that some trends have been observed--additional chro mosomes have been identified in sever al reports, tetraploidy (4 sets of chro mosomes) or polyploidy were seen In some cases and in many instances an increased frequency of chromosome breakage was reported but not well do cumented. Wolman states that: the clearest picture of the relationship be tween benzene exposure and chromosomal changes emerges, not from experimental studies or reports of human disease, but from studies of occupationally exposed workers (Ex. 43.B. p. 130). The National Research Council (Ex. 24) considers the 1969 study by Vlgllani and Foml (Ex. 2-20) to be one of the most systematic of this type reported. The results of cytogenetic analysis of 25 subjects who had recovered from benzene hemopathy were compared to the findings of controls matched for sex and age. In most cases, increased ratios of both stable and unstable chromosome aberrations were still pre sent several years after cessation of exposure to benzene and/or recovery from poisoning, whereas the hemato logical analysis revealed normal blood counts in most cases. Follow-up cytolo- glcal analyses of these subjects showed an overall decrease in unstable changes, and generally, a persistence or an increase in stable alterations. Other cytogenetic surveys of workers industrially exposed to benzene are: (Fomi et al., Ex. 2-20; Girard et al.t Ex. 2-40; Hartwich and Schwanitz. Ex. 217-129; and Vlgllani and Fomi, Ex. 2- 14). OSHA is also aware of several cyto genetic studies of workers chronically exposed to airborne concentrations of benzene probably less than 25 ppm. Several indicate an increase in chro mosomal damage (Hartwich and Schwanitz. Ex. 129; Girard et al., Ex. 2-65 or 2-283. and Berlin et al. Ex. 2A- 218) while others present negative findings (Fomi, Ex. 156.H: Tough et al.. Ex. 2-21B. and Burgattl, Ex. 2A- 226). 0000^23* ViJ.lf.I.cd by TIIK IIUWKAU oi-' NATIONA1. AM-AIKS. IV... WASHINGTON. D.C. .'O'IN CURRENT REPORT 1421 The final standard provides for medical surveillance in addition to semi-annual routine blood testing. Where routine medical surveillance re veals an abnormal blood picture, the employer is required to refer the em ployee to a hematologist. Where emer gency situations occur, the employer is required to provide a urinary phenol test and, if urinary phenols are elevat ed. a repeat complete blood count (CBC); If the CBC reveals abnormali ties then the employee must be exam ined by a hematologist. The cost of these non-routine examinations was not estimated by ADL since they would not have been required by the proposal. There is, of course, no cer tain way of determining the number of employees who will need examina tion by a hematologist. To calculate these additional costs, therefore, OSHA has assumed that 5% of all em ployees will have abnormal blood pic tures and will be re-referred to a he matologist. and that the added cost will be $100 per referral. Other Costs Total costs for other compliance ac tivities, such as engineering controls, respirators, training, and signs and labels have also been assessed. These costs are based essentially on the cost factors furnished by ADL since the ADL costs were generally accepted by industry participants. Capital costs for engineering con trols have been determined for Indus tries with operations above the per missible exposure limit on the basis of the type of engineering controls avail able for the Individual Industry. Many of the industries covered by the ben zene standard Involve the storage and movement within a closed system of liquids containing benzene In various concentrations. Emissions occur at such points as pumps, pipe line joints, compressors, sampling points, and gauging stations. (Vol. 1, 4-35). Engi neering controls for these systems con sists of replacing worn pumps and compressors with equipment specifi cally designed to minimize emissions, replacing gaskets to ensure tight fit of joints, welding Joints, and the installa tion of automatlve gauging and closed loop sampling devices. Specific units of these systems have been costed by ADL and aggregate costs shown below are based on an estimated number of these units which are required for a typical plant. To determine respirator costs. OSHA has used ADL's cost per employee for respirators. (Vol. II C-8, 9). For personal protective equipment, which is required by the standard for employees who may be exposed to eye or repeated dermal contact with ben zene, the cost of $13.16 per employee per 'p-'.r Y.-'s been used. This cost Incl:: 'oves, apr.'.':, face- R>. Training costs, which Include costs for preparation, materials, employee's time, and instructor's time, have been estimated at $110 per facility plus $14 per employee (Vol. II C-II). In calculating recordkeeping cost, OSHA has utilized the ADL cost factor (Vol. II C-12) for record mainte nance but adjusted this cost to reflect the decrease in the records required by the final standard. In Its testimony, AISI expressed the view that record keeping would require the addition of one record clerk per facility (Tr. 3165317 I). However, the final standard sig nificantly reduces the monitoring re cords and eliminates medical records for employees whose exposure is below the action level. Therefore, applica tion of ADL's cost formula will give a reasonable approximation of the re cordkeeping burden. For most firms, a normal cost for labels has been determined on the basis of ADL's cost of estimate (Vol, II, C-13). No cost has, however, been determined for signs. Detailed data on a plant-by-plant basis were not avail able to OSHA. Therefore, no costs for this compliance activity are included within the cost estimates shown herein. OSHA recognizes that these costs will occur but is of the opinion that they will be relatively small for all firms covered. Compliance costs for the following Industries have been calculated by OSHA using the compliance factors described above. Petroleum Refineries It Is estimated that petroleum refin eries will incur greater compliance costs than any other Industry sector. This Is primarily due to the large number of refinery workers who are exposed to petroleum products, almost all of which contain benzene. There are 48 refineries engaged fn the pro duction of benzene and 275 refineries which do not produce benzene but maintain process streams with ben zene concentrations. At the 48 refineries which produce benzene, there are approximately 1,440 exposed workers. On the basis of the exposure data made available by ADL and industry witnesses, it ap pears that approximately 20% of these employees are exposed above the per missible exposure limit. OSHA has, therefore, applied the ADL sampling protocol and calculated costs on the assumption that initial measurement will show aporoxlmately 300 workers exposed above the permissible expo sure limit. The remaining exposed workers were divided for cost calcula tion purposes. Capital investment to reduce exposure levels has been esti mated at approximately $24 million extrapolating from a model plant anal ysis. This cost ~ - ment of (ADL. E-l) and similar indicated im proved maintenance and repair. No es timate Is made for shut down time since it is anticipated that any con trols including modifications of pumps and compressors, would be installed during normal down time (Tr. 536). OSHA does not concur In the API view (Scarborough statement p. 36-7) that additional down time is needed since normal maintenance procedures of highly flammable material require purging of lines, and replacement of seals, pumps, etc. First year operating costs for these refineries are estimated at approximately $600,000. Cost estimates for the 275 refineries which do not produce benzene were based on API's and ADL's data as to 98,000 exposed employees. (ADL, Vol I, p. 419; add API reference for that number). ADL relied in part on the re sults of an API questionnaire which indicates a wide range of exposures from negligible to as high as 25 ppm. (ADL pp. 4-16 to 4-17). API's witness indicated that exposures at refineries were very low with most below the proposed permissible exposures limit and many below the action level (Tr. 1467-1468). Other testimony indicates similar exposure .patterns (Grosplron statement, pp. 4-6). -The API post hearing submissions suggest that re finery workers move frequently from one post to another so that they are not exposed to hydrocarbon vapors for extended periods of time (API, PH5). Initial monitoring results showing 8 hour TWA measurements of 0.13 ppm and lower were cited by API. (API PH 8-9.) In the face of conflicting data of this sort, it was assumed that approxi mately 5,000 workers initially could be found to be exposed above the permis sible exposure limit, that approximate ly 5,000 would be exposed at levels be tween the permissible exposure limit and the action level, and that the re maining 88,000 would be below the action level. This distribution indicates somewhat higher exposure levels that API's testimony suggests, but lower levels than the results of the API questionnaire survey might be con strued to indicate and is. therefore, in tended to be a reasonable estimate. Using this distribution. OSHA esti mates first year operating cost for compliance to be approximately $12.8 million. It may be noted that approxi mately $2 million of the Indicated first year cost is for exposure measure ments. Since many refineries have ap parently made such .iasurements, actual first ;-`ar cor.'.. . r.ce costs may be substantially lower than the esti mates listed herein. The cost Of capital Investment in en gineering controls is estimated to be $110 million, for control of leaks from seals and valves, control of sumps and `-osal ** hCD 000019^ I\,|.| is hr. I [,y Till-: HCKKAd Ol-' S,\ I A I. A I- KAIIC-., /NT , WAS! II M. TON . DC. 2HD.17 CURRENT REPORT basis of the Quality and cost of avail able substitutes. OSHA believes that thi soning followed by ADL In this qu&...<itive analysis is reasonable. Using an estimate of relatively in elastic demand for benzene (elasticity *> -- 0.5) (ADL pp. 6-11) and an esti mated price Increase of approximately 1 percent, ADL estimated that demand for benzene would fall by approxi mately 0.2 percent (16 million pounds) In the short run and by approximately 0.5 percent (54 million pounds) in the long run for refineries and steel com panies producing benzene. Since the demand for benzene is growing moder ately, these decreases would represent a slight decrease in the amount of growth, rather than an absolute de cline from current levels of produc tion. Foreign trade accounts for only 5 percent of U.S. supply and Is not ex pected to be a significant factor affect ing domestic producers, considering the small projected change in price. The price of benzene is determined by petroleum refiners, who supply 95 percent of the market. Since coke oven producers will incur higher compliance costs than the benzene producing re fineries. they will be able to recover only part of their costs through price Increases and will be adversely affect ed by the standard. It appears prob able that some producers of benzene from coking operations will choose to sell their light oil to other firms rather than continuing to produce benzene (AISI). Similarly, some refin eries now producing benzene may elect to change their product mix to elimi nate benzene production. These deci sions will be made by benzene produc ers on the basis of many factors affect ing the profitability of benzene pro duction and not on the basis of the impact of this standard alone. No data were submitted in the hear ings that provided a basis for estimat ing the number of firms that may eliminate benzene production. It was not contended, however, that any pro ducing firm will be forced to close or be forced into an unprofitable position as a result of the compliance costs as sociated with this standard. Impact op Price on Employment and Productivity Since ADL projected no absolute de crease in total production of benzene. It did not project employment losses for benzene producers. API witnesses questioned this on the basis of their challenge of the analysis of demand elasticity, price change, and reduction of demand. (Scarbrough, pp. 24-25; Henderson) OSHA reasons, however, that if these elements of the analysis are acceptable, the conclusion that production employment will not de cline is valid, although some realloca tion due to structural changes in the industries may occur. API also argued that increased labor cost resulting from compliance pro grams could lead to some substitution of capital for labor. (Henderson, p. 10) In its testimony. ADL pointed out that the productivity of both labor and cap ital would decline In the same order of magnitude and that this would indi cate that substitution would not occur. (TR p. 584) ADL also submitted that the industry sectors In question are quite capital Intensive and that for this reason, "it is not anticipated that the proposed regulation would have any observed effect upon the utiliza tion rate for labor in these industries.'' (ADL post hearing. Ex. 15N) OSHA recognizes that some decline in overall labor productivity may result from adding compliance person nel such as technicians and hygienists to the work force of benzene produc ers. although the direct productivity of production workers is not affected. This decline was estimated by ADL to be approximately 1.4 percent for coke producers and 0.6 percent for refiner ies (ADL, Ex. 5A. Table 6.5. p. 6-16). Benefits The legislative history and language of the Occupational Safety and Health Act, as distinguished from some other environmental and safety legislation, clearly indicate that Congress has al ready arrived at a judgment concern ing the balancing of cost and benefit, with the result that worker safety and health are to be heavily favored over the economic burdens of compliance. Specifically, Section 6(b)(5) of the Act provides that the Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately as sures. to the extent feasible, on the basis of the best available evidence, that no employ ee will suffer material Impairment of health or functional capacity even if such employ ee has regular exposure to the hazard dealt with by such standard for the period of his working life. Development of standards under this subsection shall be based upon research, demonstrations, experiments and such other information as may be appropri ate. In addition to the attainment of the highest degree of health and safety protec tion for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws. Thus, while feasibility ts an appro priate consideration, the Secretary Ls directed to set standards which attain the "highest degree of health and safety protection for the employee m rr This does not mean, however, that a systematic evaluation of costs and benefits is not to be encouraged within the limits of the estimation tech niques. In considering the issue of fea sibility In this rulemaking, as in others. OSHA has carefully evaluated the cost of compliance which may be incurred by the directly affected em ployers and their ability to comply. Additionally. OSHA believes that a standard for a substance which has been found to pose a cancer risk to workers, in this case benzene, must assure maximum benefit (i.e.. preven tion of serious illness or death), con strained only by the limits of feasibil ity. There is general agreement that benzene exposure cases leukemia as well as other fatal diseases of the bloodfortning organs. In spite of the certainty of this conclusion, there does not exist an adequate scientific basis for establishing the quantitative dose response relationship between expo sure to benzene and the induction of leukemia and other blood diseases. The uncertainty In both the actual magnitude of expected deaths and in the theory of extrapolation from ex isting data to the OSHA exposure levels places the estimation of benefits on ``the frontiers of scientific knowl edge." While the actual estimation of the number of cancers to be prevented Is highly uncertain, the evidence indi cates that the number may be appre ciable. There is general agreement that even In the absence of the ability to establish a "threshold" or "safe" level for benzene and other carcino gens. a dose response relationship is likely to exist; that is, exposure to higher doses carries with It a higher risk of cancer, and conversely, expo sure to lower levels is accompanied by a reduced risk, even though a precise quantitative relationship cannot be es tablished. In light of the uncertainties In this area of scientific knowledge, OSHA believes that It 1s required by prudence and by the statutory man date to adopt a highly protective pos ture In considering the evidence for health benefits. Various witnesses argue that cost benefit or cost effectiveness should be the primary criterion for regulatory decision. OSHA was criticized by in dustry participants for failure to con sider what benefits would be derived from reducing the current permissible exposure level for benzene (API brief, page 92, 96; AISI brief, page 89, 97), The Council on Wage and Price Stabil ity (CWPS) also suggested that OSHA estimate the incremental reduction in heaith risks which are associated with the reduction in employee exposure to benzene (Bosworth letter, 9/12/77, to Bingham). Both CWPS and industry suggested ways In which this could be achieved, CWPS suggested that OSHA apply the expected lifetime Incidence rates of leukemia and the increased inci dence rates revealed by the scientific studies to the benzene exposed popula tion to derive the number of expected 1 M till . IH'VI All l <) *:.\l It ' A | M l AIK-. I v-iti-.c.'inN i"'. .'-I" MCD 000019239 CURRENT REPORT 1429 regulatory action to be taken on non* gasoline motor fuels after review of the data and recommendations of the Joint Federal task force and evaluation of the Information furnished in re sponse to OSHA's notice on gasoline. For these reasons. OSHA has exempt ed from the permanent benzene stan dard the storage, transportation, dis tribution. dispensing, sale or use as a fuel of all fuels (including gasoline, jet fuel, and diesel fuel) subsequent to their discharge from bulk terminals. Closed Systems Some participants requested exemp tion from the standard for workplaces where benzene Is present solely in closed systems. The record evidence, however. Indicates that closed systems frequently develop leaks, and that it is the amount of the solvent exposed to air (Tr. 3111-3) which, among other variables. Is a major determinant In the degree of exposure. Accordingly. OSHA has retained coverage of closed systems In the final benzene standard. However, in the absence of leaks, ex posures from closed systems should be below the action level and the Impact of the standard In such operations Should be minimal. Lasoratories Still another segment of Industry re quested an exemption from the ben zene standard. Many comments re quested that research facilities In both industrial and academic laboratories be exempted from the benzene stan dard (Com. Nos. 14. 20. 57. 62. L.C. 12. L.C. 13) particularly where the permis sible exposure limit is not exceeded (Com. 56. 58). Some comments sug gested that separate requirements be developed for laboratory use of ben zene (L.C. 12. L.C. 13). These require ments could Include mandatory use of hoods (L.C. 9. Com. 21) of a specified velocity (LkC. 8. Com. 18) and periodic medical surveillance (Com. 18. 28. 29. 64, 70); annual inspection In lieu of monitoring (Com. 28): written safety rules (Com. 18) and container labeling (Com. 39) were also suggested. In the alternative, it was suggested. OSHA should promulgate separate regula tions for all chemicals used in labora tories (L.C. 12. L.C. 13). since laborato ries use a variety of chemicals, and compliance with separate regulations lor each chemical. It was argued, would be burdensome (Com. 58). The requests for exemption from the benzene standard or for special treatment of laboratories were largely based on the view that there exists a lesser, or slight, risk of exposure to benzene for laboratory technicians. In support of this contention, laborato ries pointed to the manner In which they use benzene. Laboratories, it was stated, generally use small quantities of benzene at a time (Com. 10, 28, 38). One laboratory reported that some times a sample is dissolved In only one ml of benzene (L.C. 2). That laborato ry estimated that an Individual labora tory technician, who analyzed 25 sam ples per day. 7 days a week, would use less than four gallons of benzene a year (L.C. 2). When not in use. ben zene Is stored In closed containers (L.C. U. The argument that laboratory tech nicians are trained In the hazards of chemicals was also made to support the vtew of lesser risk. One laboratory reported that It conducted blood tests every four months for twenty years of its technicians, and found no problem (Com. 4). Another reported that In thirty-five years, none of Its employees developed leukemia even though expo sures In the laboratory were between I and 20 ppm (Com. 31). Another reason advanced for exemp tion or separate treatment of laborato ries was the burden and cost of imple menting exposure monitoring, engi neering controls and medical surveil lance (Com. 4, 5. 10). One Industry comment argued that responsible re search and quality control laboratories normally provide and encourage annual physical examinations that In clude the essentials of the proposed medical surveillance program (Com. 38). OSHA has determined that applying the provisions of this benzene stan dard to laboratories is consistent with OSHA's responsibility to protect the health and safety of workers. The record Indicates that exposure levels in laboratories vary greatly. While monitoring samples of one laboratory Indicated levels of only .01 ppm (Com. 28), others Indicated levels as high as 20 ppm (Com. 31; Ex. 39-3). Further more, it appears that protective mea sures vary from lab to lab (Tr. 3157). One chemist, who worked frequently and for several hours a day with ben zene during his six years In a research lab that he described as "one of the most prestigious research Institutions in the country." testified that employ ee exposures were net measured, hoods were not used, and there was no medical surveillance program <TH 3492-6). Moreover, there does not appear to be any firm basis to believe that training alone in handling of chemicals adequately protects all labo ratory employees from the hazards of exposure to benzene. Based on the above evidence. OSHA believes that laboratory employees are exposed to the leukemogenic hazards of benzene and. therefore, must be covered by this standard. OSHA does not subscribe to the view that labora tories should be exempted from the benzene standard and that protection for employees exposed to benzene should await promulgation of separate regulations for all chemicals used in laboratories. OSHA Is not currently developing a laboratory standard, and the result of exemption of laboratory workers from the benzene standard would, consequently, deprive them of the necessary protection against the hazards of benzene exposure for some time to come. Furthermore, the provi sions of the standard relating to meth ods of compliance are performance ori ented and. therefore, will encompass the suggested special requirements for laboratories. For example, the require ment that the employer Institute engi-neering controls and work practices could be met by laboratories in many Instances through the use of properly designed hoods. Also, the inclusion of an action level will minimize the moni toring and medical surveillance re quirements in laboratories where em ployee exposure measurements Indeed are low. Although OSHA has not Included special provisions just for laboratories, the provisions of the standard accom modate several of the suggestions of the participants, as noted above. Those laboratory operations where benzene exposure levels are at or below the action level will need to be monitored only initially, and medical surveillance of employees engaged in those operations will not be required. When benzene is sealed In containers, the laboratory employer will be re quired only to train his employees In the hazards of exposure to benzene, and assure that the container Is prop erly labelled, and provide protective clothing where necessary. Coke Oven Batteries Steel industry participants requested an exemption from the benzene stan dard for coke oven workplaces which are covered by the coke oven emissions standard. Although coke oven emis sions at coke oven batteries are regu lated by 1910.1029. it is OSHA's view that there Is a need to apply to these workplaces the requirements of the benzene standard, as well. The coke oven standard regulates the benzene soluble fraction of total particulate matter present during the carboniza tion of coal for the production of coke to protect workers from the risk of de veloping cancer of the lung and uri nary tract. The coke oven standard, however, was not designed to protect coke oven employees from the hazards to the hematopoietic system which can result from exposure to benzene. Benzene exposure can occur from leaks In the ovens or In the collection system or from residual vapors left in the ovens when they are opened and the hot coke Is pushed out (Little study, B-21). Accordingly, in order to protect workers from the hematopoie tic hazards presented by exposure to benzene, OSHA has concluded that In clusion of all coke oven workplaces in the benzene standard Is necessary. WCD ooo19239 I >,iiiti -.hi , i i >v iiir. mi iv i: a u or n a t n >*: a i . a i r a iks. tr,v.. ftAMiisii'idV'. PC. '.'on i? CURRENT REPORT 1433 The unloading and loading of gaso line. crude oil, and other refined prod ucts from marine vessels results In limited exposure to shoreside 'person nel ranging between 0.01 ppm. to 0.82 ppm. with an 8 hour TWA of .2 ppm. <Tr. 2271.) The shoreside personnel's potential for exposure occurs during the connecting and disconnecting of the hoses and loading arms, an activ ity of limited duration. (Puller Ex. 115, A.3, p. 4.) The unloading and loading of benzene from marine vessels, how ever, may result In higher employee exposures. The transportation by barge accounts for the majority of the total benzene transported. (A.D. Little, Ex. 5A, 4,24, 4.42.) The connecting and disconnecting, opening and closing of valves and the monitoring of fill levels are the typical operations in which employees will actively be Involved. These operations are all of limited du ration and. consequently, employees would spend little of their time in volved in them. The remainder of the employees' time would be spent else where removed from exposure. There fore, work practice controls would be extremely effective in reducing em ployees' exposures to benzene during the unloading and loading of marine vessels. (A.D. Little Vol. 1, May 1977 p. 4.27.) One methodology discussed to reduce exposure to vapors is a marine vapor recovery system (Puller. Ex. 115-A.3). However, at the present time, questions concerning fire and ex plosion risk, and potential structural damage to barges have, not as yet, been adequately resolved. The exposures measured during the unloading of gasoline at bulk termi nals are low. Sexton, an Industry spokesman, reported that the highest long-term samples on individual truck operators was 0.41 ppm., with the vast majority being below 0.2 ppm. (Ex. 115-A.10.) These terminals from which the exposure data was obtained repre sent examples of the various types of truck loading techniques and different physical characteristics of the termi nals, such as loading rates, covered versus uncovered loading racks, and floating roof tops. Data presented by Williams Pipeline also showed exposure levels, for the most part, below 0.5 ppm. on an 8 hr. TWA basts. It. therefore, appears that one or a combination of these avail able engineering controls will be suffi cient to reduce employee exposure below the permissible exposure limit. Approximately 94% of the benzene produced Is derived from petroleum through the process of catalytic re forming. recovery from pyrolysis of gasoline and hydroaikylation of to luene. Many of the processes used to produce benzene involve completely enclosed units such as reactors. How ever. these processes do contain vents and other sources of leaks, which can result in significant exposures (A. D. Little. Vol. II-B11). Control of emissions can be accom plished by such activities as removal and reinstalling equipment such as pumps, compressors, machining of parts, cutting and welding of piplines, fabrication of equipment, replacement of gaskets. Also, the use of automatic gauging devices, closed loop sampling systems, vapor recovery units, floating roof installations and rupture discs has been suggested (Ex. 5A, 4-53). The majority of employees exposed at petrochemical plants are already within the permissible exposure limit. (Ex. 111-A, pp. 4-7.) At only four of twelve plants surveyed, exposures were above 1 ppm. (ADL. May 1977 p. 10, Table 2). and of those four plants only two were above 5 ppm. The fact that eight of those twelve plants were already within the permissible expo sure limit suggests that other plants can be rehabilitated with existing technology to achieve levels within 1 ppm. The record indicated that exposures to benzene vary between 0.1 ppm and 20 ppm. (Com. 28, 31). The differences In exposure levels appear to be due U) the particular protective measures em ployed in the laboratory. (Tr. 3157, 3492-6). On the basis of this evidence, OSKA has determined that the use of a properly operating laboratory hood is one available engineering control which is currenty reducing employee exposures (See ADL 4-41) well below the permissible exposure limit. The type of control selected will be depen dent upon the individual laboratory. (ADL May 1977 pp. 4-40 and 4-41.) The two segments of the steel indus try wherein benzene exposure occurs are the coke oven battery and the light oil distillation plants. Exposures at the coke oven batteries range be tween 0.02 ppm and 0.31 ppm. (Ex. 135 p. 4 and Attachment 2). It is thus ap parent that the steel industry's com pliance with the Coke Oven Emission Standard will maintain benzene expo sures well below the action level. Within the distillation plants, equip ment Is used to distill the benzene out of the light oil. It is In this operation that the steel Industries claim that in certain situations it will not be feasible to reduce exposures through engineer ing controls. It appears, however, that those situations are limited to the older "coke driven by-products plants" (between 30. 40, and 50 years old). (PC 36 AISI Brief, p. 87-88) and does not exist for the newer plants which cur rently have low exposure levels. As the Courts of Appeals have em phasized. OSHA. Is not restricted to the status quo. Standards may be set which require Improvement In existing technologies or which require the de velopment of new technology and OSHA is not limited to setting stan dards based solely on devices currently available, at least where new technol ogy appears on the horizons to limit exposures below the permissible expo sure limit. (See e.g. Society of Plastics Industry v. U.S. Department of Labor, 509 P. 2d 301 (C.A. 2. 1975) cert. denied.) Certainly here, the evidence indicates that technological controls to reduce exposures. If they are not universally used, do exist (Ex. 5A. 437). Benzene exposure may occur in a va riety of industries when solvents con taining small quantities of benzene are utilized. Some examples are the rubber industry, the manufacture and use of adhesives, paint manufacturing and application, metal can production and commercial printing. Evidence in the record Indicates that, with the ex ception of paint remover firms for the most part have restricted the u$e of benzene as a raw materials. It appears, therefore that the percent of benzene coupled with presently available engi neering controls, such as local exhaust systems, results in minimal employee exposures, (May 1977 ADL p. 4-27, 4032). Based on the record of the benzene rulemaking. OSHA has concluded, as indicated above, that the permanent benzene standard is technologically feasible. Furthermore. OSHA has de termined that this standard better ef fectuates the purposes of the act than the national consensus standard for benzene. Dermal and Eye Exposure Limits: Paragraph (c)(2). The final standard, like the emergency temporary stan dard and the proposed standard, pro hibits all eye contact and skin contact with liquid benzene. This requirement is based on OSHA's policy that, in dealing with a carcinogen, ail potential routes of exposure (i.e. inhalation, in gestion. and skin absorption) be limit ed to the extent feasible. Although the record evidence does not conclusively establish what the ef fects of contact with benzene are on the eyes or the skin, participants gen erally did not oppose a requirement for restricting such contact. Indeed some participants indicated that they already provide protective clothing and equipment to their employees In order to protect them from possible hazards of contact with liquid ben zene. The record evidence on the effect of liquid benzene on the eyes or the skin Is extremely limited. No scientific data as to the effects of benzene on the eyes was presented during the rule making proceeding. The few studies of skin effects on animals and humans (Ex. 2-48, 2-47, 2-48, TR 2459-90) are not definitive as to the extent of ben- sene that is absorbed through the Intact skin or as to the comparative WCD 000019240 a Tin-; nuuKAi; or na i iona i. ai-kaiks. inc.. wamiinoton, f>.c. CURRENT REPORT 1437 result. Redetermination of exposure must also take place after the cleanup of spills and the repair of leaks, rup tures or other breakdowns. One com ment suggested that redetermination not be required In these Instances CL.C. 19). OSHA has not adopted this suggestion. Spills, leaks, etc., can result In very high exposure levels (Tr. 1299; P.C. 30, p. 48). and the require ment to redetermine exposures after cleanup or repair provides one method of ascertaining that proper corrective methods have been Instituted and em ployee exposures are not significantly altered. The final standard further requires that employers notify each of their employees of the exposure measure ment which represents that employ ee's exposure. This requirement is dis cussed In detail under Recordkeeping. It should also be noted that para graph (m> of the standard requires the employer to allow employees or their designated representatives an opportu nity to observe the monitoring. The specific provisions of paragraph (m) are discussed below. Methods of compliance: paragraph if). The final standard, as the pro posed standard, requires employers to Institute engineering and work prac tice controls to reduce employee expo sure to benzene to or below the per missible exposure limits, except to the extent that such controls are not fea sible. This requirement is In accord with OSHA's policy that feasible engi neering and work practice controls must be used as the primary methods of reducing employee exposures. This policy is based on the view that the most effective means of controlling employee exposures is to contain con centrations at their source through use of mechanical means combined with work practices rather than reli ance on the variability of human be havior so critical to the successful use of respirators. Thus, the standard also provides that, in situations where fea sible engineering controls and work practices are insufficient to reduce ex posure to the permissible limits, the controls must nonetheless be used to reduce exposures to the lowest achiev able level, and then be supplemented by the use of respiratory protection. In reaching the decision to require engineering and work practice controls as the primary methods of reducing benzene exposures. OSHA has careful ly considered the objections of various participants. While recognizing that In many situations engineering and work practice controls are the preferred methods of reducing exposures to or below the permissible levels, several participants recommended that the hierarchy of control measures be .eliminated and employers be allowed the freedom of selecting the control measure to be instituted. (Tr. 3140). These participants particularly object ed to the requirement that engineer ing controls and work practices be used to reduce exposure to the lowest achievable level even if that level is above the permissible exposure limit. Various arguments were made In sup port of this position. One participant pointed out that, where the controls will not reduce exposures sufficiently, respirators . will have to be used anyway. This employer suggested that OSHA mandate the continued search for controls which are sufficient to reduce employee exposure, but allow employers to select any appropriate method of reducing exposures (Com. 43). As was pointed out in the benzene hearing cEx. 59, p. 12). as well as in other OSHA rulemaking proceedings, respirators are the least satisfactory means of control because of difficul ties inherent in their design and use. Respirators are capable of providing good protection only if they are prop erly selected for the types and concen trations of airborne concentrations present, properly fitted and refitted to the employee, worn by the employee, and replaced when they have ceased to provide protection. While it is theo retically possible for all of these condi tions to be met. It Is more often the case that they are not. Consequently, the protection of employees by respi rators Is not always effective and Is, therefore, permitted only in certain specified circumstances. For example, proper facial fit. is essential but, due to variations in fit, individual facial di mensions and the limited range of the facepiece configurations, such fit is difficult to achieve. (Tr. 332-335) Often the work involved is strenuous and the increased breathing resistance of the respirator reduces their accept ability to employees. Safety problems presented by respirators must also be considered. Respirators limit vision. Speech is also limited. Voice transmis sion through a respirator can be diffi cult. annoying and fatiguing. Move ment of the Jaw in speaking also causes leakage. Communication may make the difference between a safe ef ficient operation, on the one hand, and confusion and panic, especially in difficult and dangerous Jobs, on the other hand. Moreover, skin irritation can result from wearing a respirator In hot. humid conditions and such irrita tion can cause considerable distress and disrupt work schedules. It Is clear, therefore, that respirators cannot be considered as the primary means of employee health protection. Neverthe less, respirators do provide some pro tection and OSHA has concluded that under certain limited circumstances, where no alternatives are available, respirators may be' used to reduce em ployee exposures. Industry participants further argued against a system of priorities because of alleged unfeasibility of engineering controls. Most of~these participants' objections to methods of compliance, however, lie in the area of economic rather than technological feasibility (Com. 49, p. 5; Com. 54, p. 2; Com. 73, p. 3). As discussed below, OSHA has determined that this standard is feasi ble and that the implementation of engineering and work practice controls Is for the most part technologically feasible. However. OSHA realizes that, under some particular circumstances, engineering and work practice controls may not be technologically feasible in a particular work operation. There fore, the standard explicitly recognizes that an employer may demonstrate the Infeasibility of engineering and work practice controls as to one or more operations in a particular pro cess, and in these circumstances use respirators to provide the required protection. The question of whether an employer has met its burden of es tablishing that engineering and work practice controls are infeasible in a particular work operation Involves the consideration of many complex factors and a rational balance process. Factors such as levels of exposure, useful re maining life of the equipment and the effort made by the employer to imple ment such controls are relevant. In addition to the obligation to insti tute engineering and work practice controls, except to the extent that such controls are not feasible, the final standard also requires that each employer establish and implement a plan. Including schedules for reducing exposures to within the permissible exposure limit or to the greatest extent feasible, solely by engineering and work practice controls. These written plans must be furnished upon request for examination and copying to representatives of the Assistant Secretary and the Director. These plans must be reviewed and updated periodically to reflect the current status of exposure control. Some par ticipants felt that the requirement for written plans was burdensome and un necessary (Com. 45, 59). OSHA, how ever. views the requirement for writ ten plans as an essential part of the compliance program since it will en courage employees to actually achieve the controls and also provide the nec essary documentation to OSHA, em ployers and employees of the compli ance methods chosen, the extent to which controls have been instituted and plans to institute further controls to achieve safe and healthful work places. A compliance issue relating to the requirement for engineering controls and work practices in this final ben zene standard Involves the relation ship of that requirement to the cov ered employers' legal obligation as to engineering controls under the prior 1 uMi-.lu MCD 000019241 'lln. I !'> I K I A I ( ' | N A : It A t . A I rAIK-X INC , \V A si U 'C . I l i N, i> C . JO'' 17 CURRENT REPORT 1441 hemolytic states and other abnormali ties. Because of the non-specificity of these two assays relative to benzene toxicity, the time-consuming nature and Instability of the reticulocyte preparations, these particular tests were the object of much comment and criticism. Several commentators stated that although these tests were of liLtle value on a routine basis, they should be made part of a preplacement or baseline exam (Com. 23, 72). Based on a review of this issue. OSHA believes that these two particular blood exami nations should be included as a part of the Initial laboratory tests only, to provide a more comprehensive picture of a worker's hematological profile, for possible later comparative purposes. Several hematologists stressed the importance of obtaining pre-exposure data as a baseline against which latter comparisons could be made (ORC/ J&ndl. P.C. 34. p. 36; Battle, P.C. 26C: Goldstein Ex. 73. p. 5). The initial exam requirement of the standard ap plies to both employees already ex posed to benzene at or above the action level as well as to new or reas signed employees who may be exposed at or above the action level, in the first case, the blood data obtained Is not, of course, a true non-exposed ba seline, but may be useful at a later date should significant changes In blood values occur. In addition, since the standard requires that an initial laboratory exam be performed for all new or reassigned employees prior to their actual exposure to benzene at or above the action level, pre-exposure baseline data will gradually become In creasingly available in the years subse quent to promulgation of this stan dard. As an aid to physicians for compar ing the results of the most recent blood testing with early data, the re cordkeeping- paragraph requires that, at the completion of the differential count, the slide of a peripheral blood smear be made permanent and stored for possible future reference. Reten tion of the slide allows the examining physician to directly compare the most recent findings with earlier ones, especially with respect to possible changes In morphology of the blood cells; counting data alone would not permit this type of comparison. Doc Chemical suggested that kidney and liver function tests should be per formed as a part of the prepiacement examination (Tr. 2967). OSHA recog nizes that these laboratory examina tions may identify conditions indica tive of an impaired ability to detoxify benzene. However, given the low per missible exposure limit mandated by this standard. OSHA concluded that requirement of these tests would be excessively burdensome. In this regard, Goldstein testified that he saw no value to incorporate these tests (Tr. 380). Pebiodic Examination The medical surveillance section re quires that a brief updated history be taken semiannaily at the time of one of the blood examinations. Battle sug gested that such a history Include que ries as to exposure to drugs or chemi cals as well as recent Illnesses since the last history (P.C. 260. Because these agents may act to adversely affect the hematopoietic system and may be reflected In the blood picture, OSHA agrees with these particular suggestions and has incorporated all of them into the requirements for the Interval history. The periodic laboratory tests are similar to those specified for the ini tial exam, except that serum bilirubin and reticulocyte assays are deleted since, as stated above, the two assays are required only In establishing a ba seline. Comments received by OSHA concerning the frequency of Interval blood examination ranged from quar terly (ORC. P.C. 34. p. 11; Tr. 3382, Tr. 270) to 3 times a year (Com. 28; Tr. 3328,' Battle. P.C. 260. semiannually. (Tr. 3138) to those who felt the fre quency should in some manner vary according to the exposure level (e.g., Tr. 2965, 6-10, 8-37, 6-47, 6-64. 6-76, 41-3, 41-19). Dow expressed the view that the frequency should be the deci sion of the responsible physician and related to the medical condition of the employee and the environmental con trol of the specific work area <Tr. 2965). As detailed previously, there Is Insufficient information in the record to allow a precise determination of op timum testing frequency. No com pletely reliable Information exists on the number of months which elapse between the first laboratory signs of a blood disorder and the onset of clinical disease or what effect a particular time delay has on therapeutic out come. There Is no reason for casual ness about the testing frequency though, since even If a blood change were to progress steadily downhill, early detection and treatment may provide substantial benefit. It is OSHA's Judgement, following exami nation of the various options available, that a six month Interval between rou tine blood examinations is appropri ate. The standard contains a provision, applicable to both the Initial, periodic and emergency exams, requiring that employees' abnormal test results must be referred to a hematologist for fur ther evaluation should certain speci fied warning signs appear. This provi sion. which was not a part of the pro posal. Is In response to recommenda tions that: (1) A hematologist be In cluded in some manner in the medical survelllence program (ORC/Jandl, P.C. 34); (2) specific quantitative guidelines including ranges (Ex. 6-60) be given physicians and; (3) that addi tional laboratory tests should be given if an abnormal count becomes mani fest or significant changes occur rela tive to baseline values (NPRA, Tr. 3325-3331; AISI. Tr. 3263-64; ARCO. P.C. 320. With respect to item (1), an industry participant testified that it was already the practice at his compa ny to refer workers to hematology spe cialists 1/ blood abnormalities are dis covered (Joyner, Tr. 2286-87), and Dow remarked that they discussed ab normal blood findings of workers with the hematologists (Tr. 3021). Also Arco commented that, if abnormal conditions arise among its employees exposed to benzene, follow-up exami nations are given and medical treat ment performed until blood tests reveal values within the normal range (P.C. 320. Also, Dow disclosed that, for Its imployee exposed to benzene, an Increased medical survelllence pro gram would result if conditions such as an undiagnosed anemia or leukocy tosis were detected (Tr. 2984-85). Sakol has noted that ineffective and Inappropriate medical treatment was given to workers apparently suffering hematological disorders from benzene exposure which ultimately evolved Into a frank leukemia (Tr. 303). This Incident further illustrates the need for a specialist's evaluation, if abnor malities are detected. Again It should be emphasized that the question of what constitutes the earliest laboratory evidence of chronic benzene toxicity Is not known with certainty (ORC/Battle, P.C. 26C, p. 3). It Is known that the level of all 3 blood cell lines may be variously affected by exposure. However, examination of the benzene literature reveals that the hematological boundaries of what is considered "normal" have varied. More recent tabulation of normal ranges are those published by NIOSH (Ex. 2-2, p. 135): Wintrobe (Ex. 2-107, p. 1791, 1794, 1795) and those submit ted by Jandl (ORC/Jandl. PC 34. p. 29). The normal range of hematologi cal values presented generally agree quite well, especially those .given by Jandl and Wintrobe. It is OSHA's con clusion that laboratory findings beyond these ranges must require ad ditional evaluation by a blood special ist. In specifying the values beyond which findings are considered abnor mal, OSHA utilized the values in the above citations to yield the widest range (often the range limits do not exactly coincide) in order to minimize the burden on the employer in border line cases. However, as Illustrated by Goldstein, It may be possible for some individuals to experience a significant hematologi cal response to benzene exposure and yet exhibit blood values within the range normal for the population as a whole (Goldstein, Tr. 356). To Identify such workers for referral to a hema- MCD 000019242 Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. D C. 20QJ? CURRENT REPORT 1443 In making these determinations. Like wise. the requirement that the em ployee be provided with a copy of the physician's written opinion will assure that the employee is informed of the result of the medical exam and may take appropriate action. Comments suggesting that the physician's opin ion be communicated only if there are problems or only upon request are not acceptable to OSHA on the basis that the employer has the ultimate respon sibility to assure the protection of the worker's health. Where the findings are negative, transmittal of the doc tors opinion also provides necessary information to both parties that the employee's health has not been ad versely affected and provides docu mentary evidence that the prescribed tests were performed and were evalu ated. Other aspects of paragraph (i> of the medical surveillance section are to be discussed under Recordkeeping, para graph (1). Mandatory Removal and Rate Retention Among the issues in the benzene ru lemaking were whether OSHA should include a mandatory removal require ment--that is. a provision prohibiting the exposure of an employee to ben zene if the employee would be placed at increased risk of material Impair ment to health because of such expo sure. and whether OSHA should In clude a rate retention provision--that is. a provision requiring the transfer of such employee to another job or pro viding that removal for medical rea sons should not result in loss of earn ings or seniority status to the affected employee. These issues, as OSHA has previously stated (41 FR 46780). are related and must be addressed togeth er. Both employee and Industry par ticipants expressed their views as to several aspects of these issues in prehearing comments. In testimony during the hearing and In post hearing arguments. Subsequent to the close of the record In this proceeding, however. OSHA conducted an informal public hearing on mandatory removal and rate retention for workers exposed to lead as part of the rulemaking pro ceeding on lead. Consideration of the critical issue of medical removal pro tection is being undertaken for several pending standards together. Once this consideration is completed. OSHA will consider the extent to which the con clusions on medical removal protection are appropriate for benzene and will propose the Inclusion of those provi sions in the benzene standard. The final standard published today, there fore. does not address the issues of mandatory removal and medical re moval protection. Employee Information and Train ing: Paragraph <J). The standard re quires each employer to provide train ing to each of his employees who is or may be exposed to benzene. The need to train employees was not disputed by participants in the rulemaking pro ceeding. Some comments, however, suggested limiting the training to cer tain employees. One Industry com ment requested that workers in closed system operations be excluded from training (Com. 47). Testimony at the hearing, however, revealed that lea kages in closed systems are not unusu al occurrences and that employee ex posure during leaks can reach high levels. One comment suggested the ex clusion of workers in open system op erations where the benzene content is 1 percent or less (Com. 47). However, as stated above, it has been estab lished that a consistent predictable re lationship between the amount of ben zene In a mixture and exposure levels does not exist and this suggestion has, therefore, been rejected. Another com ment suggested the exclusion of labo ratory personnel from training re quirements on the ground that labora tory personnel have a good under standing of the hazardous nature of benzene (Com. 70). A laboratory tech nician, however, testified that during his six years working with many toxic chemicals, including benzene, he re ceived no training (Tr. 3493) and indeed neither he nor his coworkers were aware of the fact that there was an OSHA standard limiting exposure to benzene (Tr. 3492). Information and training are essential for the protec tion of an employee. Each employee can do much to protect himself if he Is fully informed of the hazards in his workplace and the protective equip ment he should use. Furthermore, eaqh employee, who Is fully informed of the obligations which the standard imposes upon the employer, can deter mine if he Is working in a safe and healthful environment. For the rea sons stated herein. OSHA believes that training must be provided to all employees in workplaces where ben zene Is present. A trade association, while not disput ing the need for training, suggested that employee training not be includ ed In the benzene standard but await development of a comprehensive em ployee Information and training stan dard based on the report of the Advi sory Committee on Hazardous Materi als Labeling and/or NIOSH's criteria document entitled "A Recommended Standard . An Identification System for Occu pationally Hazardous Materials" (L.C. 14). OSHA deems it necessary for the protection of the health of employees to include the training requirements in the benzene standard at this time. The standard specifies the contents of the training program. The Informa tion which must be Imparted to the employee must include the nature of benzene related health problems, the necessity for exposure control, and the purposes of medical surveillance and respiratory protections. No partici pants objected to any of these Items. Two participants suggested that em ployees should also be trained In "early symptom diagnosis to detect acute leukemia" (Ex. Dow Venable statement, pg. 3; Tr. 3192: Ex. 154: Tr. 2963-3056). These participants, howev er. testified thae the most common manifestations of acute leukemia are fatigue and nosebleeds and that these symptoms are not specific to acute leu kemia (Tr. 3193). The signs and symptoms of benzeneinduced diseases are described In con siderable detail in Appendix A and Ap pendix C. Both the proposed standard and the final standard specifically re quire that the employees be informed, among other things, of the informa tion contained in Appendix A and Ap pendix C. (In this connection, the em ployee should be instructed to report promptly the development of any of these symptoms which could be attrib uted to benzene exposure.) In view of the requirement to include the infor mation contained in the appendices as part of the training program, an addi tional requirement on early symptom diagnosis would be redundant. Similar ly. since Appendix B details the vola tility of benzene. OSHA has not adopt ed NIOSH's suggestion (Baler state ment, Ex. 84A p. 11) that the standard further emphasize training on the flammability of benzene. In addition to informing employees. the standard requires that the employ er make available to his employees a copy of the standard and its appendi ces. This requirement is intended to assure that employees understand their rights and duties under the stan dard. A public participant suggested that employers be required to hold classes for the training of each employee. (Ex. 183 p. 5) OSHA has not included any specific requirement to this effect in the final standard, preferring to leave the manner of training up to the indi vidual employers. Some employers will need to train individuals on a one-toone basis, depending on the number of employees at a particular workplace or involved in particular operations. Em ployers with a few employees may find it burdensome or disruptive of work schedules to conduct training in class sessions. The employer is also required to pro vide. upon request, all materials relat ed to the training program to the Sec retary and the Director. This require ment is intended to provide an objec tive check of compliance with the con tent requirements of the training pro gram. The standard requires that training of employees be conducted within MCD 00019243 11;,hcj by Tin-: ui'ukai; ok national ah'a:ks, jnc., Washington, d C. '20037 CURRENT REPORT 1435 cation of the leaks will, of course, minimize exposure and minimize the reporting requirement. Some Industry participants recommended that the standard include a method for "dere gulating" the regulated areas once ex posures fall below the permissible ex posure limits. (Com. 45, Com. 53, Com. 57) OSHA does not feel that a formal method for deregulation is necessary. Since the standard does not require maintenance of a regulated area except where exposures are above the permissible exposure limit, the regu lated area requirement does not apply where the employer has reduced the exposure levels below the permissible exposure limit. Nor would a deregula tion procedure contribute to the pro tection of employees. Moreover. If formal deregulation were required, it would be necessary for the employer to file an additional notification with the OSHA area office should condi tions change thereafter and the expo sure again exceed the permissible ex posure limits. In view of these consid erations, a formal deregulation proce dure would appear to be unnecessarily burdensome. Monitoring: paragraph (e). Signifi cant changes have been made In the monitoring section of the final stan dard In response to comments by par ticipants. Briefly, the final standard requires all covered employers to make measurements to determine whether any employee may be exposed to air borne concentrations of benzene, and Imposes different measuring require ments depending on whether exposure measurements are above or below cer tain levels. The monitoring requirements are Imposed pursuant to Section 6(b)(7) of the Act (29 U.S.C. 5 655) which man dates that any standard promulgated under section 6(b) shall, where appro priate. "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 purposes of monitoring are to deter mine the extent of exposure, to identi fy the source of exposure to the hazard and to enable the employer to select proper control methods and evaulate the effectiveness of the se lected methods. Thus, monitoring en ables employers to meet the legal obli gation of the standard to assure that their employees are not exposed to benzene in excess of prescribed levels. Additionally, monitoring enables em ployers to notify the employees of their exposure level, as required by section 8(c)(3) of the Act, and provides information necessary to the examin ing physician. The need to conduct exposure moni toring was generally accepted by par ticipants in the rulemaking process (P.C. 35MCA brief. P. 55-b: P.C. 30; ORC brief, p. 7). Many comments, however, objected to the proposal's re quirement to measure airborne expo sures in all workplaces "where benzene is present" (P.C. 33; API brief, p. 127a; P.C. 34; ORC brief, pp. 7-8). Partici pants argued that the use of the term "present" Is so broad as to encompass each and every employee at a facility (Ex. 6, No. 53). It was also argued that benzene is present in the ambient at mosphere (Ex. 6, No. 43; Ex. 84B. 18, Ex. 8-1A, p. 7) with the result that every work operation in every city would probably have to be monitored (Ex. 6. No. 43. p. 12). OSHA'a objective Is to minimize all occupational expo sures to benzene. The term "presence" was used in the proposal to convey the intent that, whenever the exposure of any employee to benzene concentra tions resulted from workplace oper ations at the place of employment, the employer was required to measure that exposure. OSHA does not intend that employees, who might be exposed solely from other sources, such as am bient levels of benzene, be covered by the monitoring requirements. In view of the confusion as to the meaning of the term "presence," the final stan dard does not use that term but in stead specifies the general classes of occupational activities which can result in employee exposure to ben zene, and requires monitoring where any of these activities are conducted. In conducting the monitoring of ex posures. the standard does not require that each Individual employee's expo sure level be measured. Although Indi vidual measurement Is the ultimate in dicator of employee exposure, OSHA believes that a requirement for indi vidual measurements may be too bur densome. Accordingly, the standard requires that the measurements be made by monitoring which is represen tative of each employee's exposure to benzene over an eight-hour period without regard to the use of respira tors. It should be noted that the re quirement for representative monitor ing does not preclude an employer from taking individual exposure mea surements of each of his employees; individual measurements are certainly considered to be representative; and the representative monitoring require ment is the minimum that the employ er must meet. In establishments having more than one work operation Involving the use of benzene, the monitoring to be rep resentative must pe performed for each type of employee exposure within each operation. One partici pant requested that area sampling be permitted in order to lessen the burden and cost of monitoring each employee with a different Job function (Ex. 0. No. 49. p. 4). Although the final standard does not specifically require personal sampling, monitoring under the standard must determine breath ing zone exposures. Appendix B, IV, therefore, recommends that air sam pling be taken in the employee's breathing zone. Area samples are generaly not as direct a measure of em ployee exposure, and consequently, may not meet the requirement for rep resentative monitoring, although where area sampling can be correlated with breathing zone exposures, area sampling may be used. OSHA, howev er, notes that while there are tech niques to correlate area sampling with breathing zone exposures, these are generally more burdensome than per sonal sampling and involve much more sophisticated data collection and anal ysis, Including the performance of per sona] sampling to assure the correla tion. Some participants suggested that employers with several places of em ployment. in which there are work places with identical processes or oper ations. be permitted to monitor only a representative number of such loca tions (Ex. 6; Ex. 50. p. 3; Ex. 60, p. 7). The fact that work operations are In different geographical locations would not in itself preclude representative monitoring. However, it is the employ er's responsibility to assure that iden tification of conditions, characteris tics. activities, climate, etc. exist so that monitoring at particular sites would actually be representative of employee exposure at other sites. The employer is also required to use a method of monitoring and measure ment with an accuracy (at a confi dence level of 95%) of not less than plus or minus 25% for concentrations of benzene of 1 ppm or more. Methods of measurement are presently avail able to detect benzene to this accuracy level (Tr. 342-3) and one such method is described in Appendix A. II. E. In dustry participants expressed concern that consistent compliance with these accuracy requirements will be Impossi ble. (PC 36; AISI brief pp. 106-108.) The record, however, indicates that, even where benzene is present with other organic solvents, the OSHA Analytical Method will still enable em ployers to measure low levels of ben zene well within the accuracy require ment of the standard. (Tr. p. 343.) Indeed. It was suggested at the hear ing that there is an alternate method for sampling, passive dosimeters, which may comply with the accuracy reqirements contained In the proposal. (Tr. 2381.) As earlier Indicated, the standard re quires all covered employers to initial ly measure the airborne exposure of all of their employees. Seme partici pants objected to this requirement and recommended that Initial monitoring be limited to those workplaces where there Is a probability of exposure to benzene in excess of the permissible WCD 00019244 -I In' TH1-: miKKAi; Ol N ATU1N A ; . A I i- AIK>, INC. . ^'ASHING ION. D C . JuO (7 CURRENT REPORT 1431 retrospective mortality studies and also experimental evidence. These studies represent the best available evidence upon which OSHA must make a decision. This decision is not predicated on any particular study, but is based on an assessment of the entire set of evidence taken as a whole. OSHA recognizes that only recently has there been a well-designed study which may indicate a leukemogenic re sponse among benzene-exposed ani mals. (Nelson. Ex. 178) In any event, the best evidence to date Is that based on direct human experience. Based upon such evidence, OSHA concludes that benzene is and must be regulated as an occupational carcinogen. Comment and testimony from indus try for the most part, does not dispute the leukemogenic potential of benzene (e.g. Eckhardt. Ex. 115.B. 1. pg. 3; Ta* bershaw Tr. 2545). However, Industry argues that this relationship is valid only at high exposure levels. In sup port of this view, they cite as evidence that: (a) the documented cases of ben zene-induced leukemia were among employees who were, most probably, exposed to high- concentrations, and (b) that several studies of undefined numbers of workers who may have been exposed to low levels of benzene did not demonstrate a leukemia excess (The benzene studies are described under Health Effects: Leukemia). In dustry also believes that observable blood disorders precede the develop ment of benzene-leukemia and that such hematological abnormalities are reversible (ORC, PC 34, p. 2: Tabershaw Tr. 2543 Jandl. PC 26B, Allied P.C. 22. p. 7), They conclude that the present exposure limits of 10 ppm TWA and 25 ppm ceiling are suffi ciently protective to guard against the development of non-maiignant blood disorders and. consequently, that limiting exposure to such levels will also protect against leukemia. (ORC, PC 34: Jandl. PC 26B: Tabershaw. Tr. 2546.) The issue of the levels at which cancer Is Induced by chemical agents and whether or not there Is a "thresh old" has been a major Issue In every OSHA rulemaking concerning the reg ulation of occupational carcinogens (See preambles to Carcinogen stan dard (39 FR 3758); Vinyl Chloride (39 FR 35892): Coke Oven emissions <41 FR 46742). The benzene hearing was no exception. As in the case of arsenic, the lack of an unequivocal animal model (Kraybiil, Tr. 758) requires chat the Secretary's decision rely primarily on data obtained from human evi dence. However, the epidemiologic method is by Its very nature, a retro spective view of the evidence, i.e. find ings of a recent excess of mortality among workers may relate to initial exposures occurring as much as 20 years or more previously and which most certainly correlate to exposures at higher concentrations than present levels. Because of these variables. It Is extremely difficult to derive definite conclusions as to the quantitative health risk to the workers at expo sures near i ppm. Studies which report negative findings, such as those studies conducted by Stallones. Tabershaw-Cooper and Thorpe suffer from the disadvantage of not being able to clearly define an exposed cohort, i.e. the Indentiflcatlon of a group of work ers actually exposed to benzene and to what levels they were, in fact, ex posed. (Stallones, Ex. 115.C; Tabershaw-Cooper. Ex. X49A: Thorpe, Ex. 234). OSHA recognizes that it is ex tremely difficult to reconstruct and define employee exposures retrospec tively. Therefore, given ihe uncertain ty of the definition of exposure and the potential for dilution of mortality excess among those actually exposed to benzene and other methodological deficiencies, OSHA Is reluctant to place substantial reliance upon these negative reports. Thus, there is little definitive Information available per taining to the leukemogenic risk of an adequate size cohort of workers ex posed to benzene less than 10 ppm and who have been followed for an ade quate amount of time. Furthermore, it is OSHA's view following a careful review of the record that, at the pre sent time, it Is Impossible to derive any conclusions regarding dose-response relationships for benzene (Goldstein, Ex. 75, p. 2 NRC, Ex. 2-4 p. ID beyond the general observation that higher exposure levels carry a greater risk than do lower exposure levels. What Is apparent however. Is that a decrease in exposure level and/or duration will result in a decreased risk of leukemia. OSHA also recognizes that, in some published cases with adequate docu mentation, leukemia attributable to benzene exposure developed after ob servable changes In the peripheral blood, i.e., various cytopenias, pancyto penia and/or aplastic anemia. (Gold stein. Ex. 43B, p. 166.) However, many cases of benzene-induced leukemias were recognized as such only after a patient with overt physical symptoms presented himself to a physician. Simi larly. Snyder stated that, in the cases of pancytopenia and aplastic anemia, individuals "exposed to benzene usual ly do not approach their physicians until late stages in the disease." (Ex. 156.2, p. 2.) As a result, the hematolo gical picture before the onset of dis ease is often not known. Moreover, be cause of the well-known reserve prolif erative capacity of the bone marrow It is possible that marrow damage may occur without being reflected In the peripheral blood. (Goldstein, Ex. 43.B, p. 175; Wintrobe. Ex. 2-107, p. 676.) Olson acknowledged that alterations In bone marrow activity can occur de spite a normal blood count (TR. 2894). Moreover. Goldstein noted that some Individuals may have significantly de pressed blood values, and yet remain within normal ranges. For this reason, a pancytopenic response to heraatotoxic agents may go unrecognized. Therefore. OSHA believes that the sci entific evidence is insufficient for adoption of the hypothesis that a pre ceding prodromal blood syndrome is a necessary prerequisite for the develop ment of benzene leukemia. In this regard, Goldstein in his testimony cau tioned that benzene may act as a direct-initiator of a neoplastic re sponse. OSHA Is also aware that in many in stances. non-malignant blood disorders resulting from chronic exposure to benzene may be reversed by removal from benzene exposure. However, the apparent high degree of reversibility, as set forth in Jandl's review, is open to question as pointed out In the Health Effects section. Furthermore, a most characteristic finding which pervades the published literature, is that physiologic factors which cannot be identified a priori, such as nutritional state, genetic con stitution. variations in metabolism of benzene and exposure (both occupa tional and non-occupatlonal) to other marrow depressants, and the variables of age and sex may act Co modify the individual's response. (Browning, Ex. 31, pp. 26 ff; Shaw, Tr. 421; Snyder, Ex. 156. p. 2.) For example. Browning stated. " [Where is no doubt that both men and women differ markedly In their response to similar conditions of exposure." (Ex. 31. p. 2.) Therefore, unqualified identification of high-risk subgroups cannot be made at present. Because of these uncertainties, this standard is designed to protect the most sensitive as well as the more re sistant members of benzene-exposed worker populations by limiting expo sure to the maximum extent feasible. It Is. therefore, clear from an exami nation of the record that a determina tion of a precise .level of benzene expo sure which presents no hazard cannot be made and that the corollary Ques tion of whether a "safe" level of expo sure to benzene exists cannot be an swered. The agency Is aware of and has examined scientific opinion and data submitted by industry that thresholds for carcinogens may exist. However, prudent public health policy requires a conservative course of action until such evidence is of a de finitive nature. In its conclusionary document the International Workshop also stated: "Itlhe workshop discussed but could not agree on whether there was a con centration below which there would be no leukemogenic effect clearly attrib utable to benzene" (Ex. 17, p. 7). Kray- MCD 000019245 r r i. v; c;r a : i-a !. ai ; aik's. inc . w am i in i , n. >7., D C 2'>`! 17 CURRENT REPORT 1427 Proposed Percentage Exclusion benzene regardless of the percent of action level would not be required. Nor r The proposal and the emergency temporary standard both would have exempted from coverage those oper benzene, It is OSHA's view that the absence of a percentage exemption does not would regulated areas need to be es tablished or engineering or work prac tices instituted or respirators provided. ations utilizing liquid mixtures con eliminate all Incentive to reduce the All other provisions of the standard, taining l percent or less benzene by volume. The proposal would have amount of benzene in liquid mixtures. Where another substance is totally however, would apply and the employ er would need to train his employees limited this 1 percent exemption to substituted for benzene, this standard in the hazards of benzene exposure, to the first year of the standard after will obviously not apply. Additionally, properly label his products and to which period only liquids containing it should be noted that the Inclusion maintain the record of the initial ex 0.1 percent or less benzene by volume of an action level will effectively limit posure measurement and. if any. the would be exempted. The proposed per the burden of this standard where em record of the redetermination mea centage exemption was based on some ployee exposure is found to be low be surement. indication that exposures resulting cause of its limited presence in a mix The adoption of an action level had from the use of mixtures containing ture. been recommended by several partici less than 1 percent benzene would gen erally be less than 1 ppm (42 FR Benzene Substitutes pants to the rulemaking. NIOSH. rec ommended that an action level for pe 27453-4). It was also anticipated that In lieu of the percentage exception, riodic monitoring and routine periodic the percentage exclusion would lead to OSHA considered the option of medical exams be Incorporated for the a reduction of the benzene content in exempting from the standard certain purpose of assuring that no employee solvents or to substitution of ocher benzene substitutes, such as toluene is exposed above the permissible expo substances for benzene with the result and xylene (although they may con sure limit (Tr. 749-750). Industry par that employee exposure to benzene tain small amounts of benzene). An ex ticipants advocated a level which would be reduced or eliminated. As a emption of this type would encourage would trigger the periodic monitoring result of evidence developed during employers to discontinue the use of of employee exposure (Com. 24: Com. the benzene rulemaking, however, benzene and utilize a substitute in 72; P.C. 36 AISI brief p. 74. FT. no. OSHA has determined that the per order to avoid the requirements im 168). A need for an action level is also cent exclusion cannot be supported on posed by the benzene standard. These suggested by the record evidence that this basis. The benzene record indi substances themselves, however, do some minimal exposure to benzene cates that there is no consistent pre contain varying amounts of benzene occurs naturally from animal and dictable relationship between the per and. as stated above, there is no evi plant matter (Tr. 749-750; 759-760). cent of benzene in a liquid mixture dence of a consistent direct predict Naturally occurring benzene concen and the resultant airborne exposure to able correlation between the amount trations, it appears, may range from benzene (Tr. 3120). Studies conducted of benzene and exposure levels. Thus, 0.02 to 15 parts per billion (Ex. 117, p. by the University of North Carolina It was concluded that toluene and 1). Additionally, It was suggested by demonstrated that exposure levels xylene, to the extent they contain certain employers that their oper varied considerably during various benzene and result in benzene expo ations be exempted from the require ( work operations utilizing liquid mix tures containing the same percent of benzene (Tr. 3090-3091). Support for sure, would be covered by the stan dard. ments of the standard because those operations involve only Intermittent and low level exposures to benzene. the conclusion that a less than one Action Level The use of the action level concept percent benzene solution can result in exposures above 1 ppm is found in tes timony suggesting that other factors than the percent of benzene in the liquid may be determinative of expo sure levels. Thus, NIOSH testified that employees working with No. 0 fuel which contains only 0.1 percent benzene were exposed to levels as high as 60 ppm under certain conditions of confined space, poor ventilation or ele vated temperatures (Tr. 754). The Uni versity of North Carolina data also re vealed that exposure levels in heavy duty tire spraying utilizing rubber sol OSHA recognizes that the lack of a percentage exemption substantially expands the coverage of the benzene standard to operations which may oth erwise have been exempt. In many of these operations, exposure levels below the permissible exposure limit have already been achieved. To mini mize the impact of the standard on those employers who have attained these low exposure levels, the final standard provides for an action level. This action level is a benzene exposure equal to one-half of the permissible exposure limit above which certain should accommodate these concerns in all cases where exposures are indeed extremely low since it substantially re duces the monitoring of employees who are below the action level and re moves for these employees the re quirement for medical surveillance. At the same time, employees with signifi cant overexposure are afforded the full protection of the standard. In developing this regulatory ap proach to occupational exposure from benzene. OSHA considered the request of those participants to the rulemak ing who pressed for exemption from vents were 1.3 ppm when sprayed by precautionary measures, such as peri the benzene standard of their particu the regular full time operator but odic monitoring and medical surveil lar operations. reached 5.2 ppm and 7.3 ppm when lance programs must be conducted and sprayed by a substitute operator (Tr. below which only a very limited Bulk Terminals 30S3). This suggests that work prac number of the standard's require The final standards apply to bulk tices are also determinative of expo ments will apply. Thus employees who terminal operators but exclude expo sure levels. To maximize protection of have an initial exposure measurement sure from gasoline, motor fuels and employees, It is necessary to reduce below the 0.5 ppm TWA action level other fuels subsequent to the dis their exposure to benzene, to the will not have to be monitored periodi charge from the bulk terminal. lowest feasible limit. Since the per cally. If the initial monitoring expo During the rulemaking, bulk termi centage of benzene in a liquid Is not in sure measurement Is below the action nal employers requested that their Itself necessarily controlling of the level, no further monitoring is neces gasoline operations be exempted from employee's exposure level, the pro sary until such time as a redetermlna- the benzene standard. Bulk terminals posed percentage exemption, would tion may be required as a result of a are the primary distribution facilities not achieve this objective. According process, control or personnel change. in the gasoline marketing network. A ly. the final standard does not contain Furthermore, medical surveillance of bulk terminal is the first distribution a percentage exemption and tnua ap Individual employees whose initial ex point of gasoline after the gasoline Is plies to all liquid mixtures containing posure measurements are below Che processed by. the refinery. Gasoline MCD 000019246 , m u ::. ! <i; .v. > ! \ ,\ i ji \.. /, i i i:u . -a a -.i l; N r, l on . n. C. jnn j? 7 f L CURRENT REPORT 1423 these exposures. It may reasonably be inferred, therefore, that all workers are exposed to benzene levels below the action level. Compliance costs, es timated on the basis of the reasoning used above, are approximately $39.6 million for first year operations and $2.5 million for recurring annual oper ations. In determining these compliance costs. OSHA has assumed 10 wells per facility in contrast to API's reference to each well as a separate facility. It is probable that even this computation overestimates first year and recurring annual operating costs, since the cost ing formula for initial measurements allocates substantial charges on a per facility basis, amounting for example to approximately 90 percent of first year costs. The estimated first year costs would be reduced by the amount appropriate for measurements already performed pursuant to the benzene guidelines or the ETS. Monitoring costs would further be reduced where exposures at one workplace are repre sentative of exposures at another. Transportation Companies engaged In the transpor tation of benzene and benzene con taminated products are covered by the benzene standard. CSHA's costs analy sis. therefore, covers the transporta tion by pipeline, marine tanker, barge, tank car and tank truck of benzene and benzene products. The cost analysis for pipelines is based on approximately 3,000 facili ties. This figure was furnished by an API witness (Scarborough) who testi fied that there were 3.000 pipeline fa cilities employing 12,000 exposed workers. A witness for Williams Pipe Line Company estimated that there are 17,000 exposed pipeline workers (Bailey). The Williams figures, howev er, may represent total employment, including administrative and clerical workers. OSHA has utilized the figure of 3,000 facilities in combination with the two estimates of exposed workers to yield a range of estimated compli ance costs. On this basis first year op erating costs are estimated to be ap proximately $2.7 million and recurring annual costs for personal protective equipment, training and recordkeeping approximately $800,000. Since the standard does not require labelling of pipelines, no iabeiling cost is Included. Neither have engineering controls been assessed since mot.-... measure ments indicate that all workers will be below the action levels (Bailey), The number of affected tank car fa cilities (loading and unloading) was es timated by ADL to be approximately 100, with an average of one exposed worker per facility. (Table 5-1) The "vprst-res of these workers will be depenuein. uu Lite quantity cu Uiu benzene-containing products shipped through the facility, the methods of loading and unloading cars, and the ef fectiveness of efforts to avoid leaks and spills. Conditions are somewhat similar to other facilities at which ben zene and benzene-containing liquids are stored and transferred. Following the sampling protocol used through out this analysis, costs were assigned on the basis that 20 percent of the ex posures are above the permissible ex posure limit, 40 percent between the permissible exposure limit and the action level, and 40 percent below the action level. It should be noted that, since it was estimated that only one worker per facility would be exposed, monitoring cost were estimated on the basis of 100 employees monitored. En gineering controls are to be installed at these facilities that will effectively control benzene emissions, bringing the exposure levels of all exposed workers below the action level. On the basis of this reasoning, it was estimat ed that compliance costs will be ap proximately $215,000 for first year op erations. $16,000 for recurring annual costs, and $200,000 for capital invest ment. Analysis of tank truck facilities shows a pattern very.similar to that for tank cars. The rationale just de scribed yield the following estimates: 200 affected facilities, 200 exposed workers, first year operating costs ap proximately $428,000, recurring annual costs approximately $37,000 and capital investment $100,000. Barges are used for the transporta tion of benzene from refineries to points of utilization. Barges also trans port various refined petroleum prod ucts primarily for discharge at bulk terminals. It is estimated that there are 480 employees and 240 barge facili ties Involved in the transportation of benzene. The record indicates that em ployee exposure during loading and unloading exceeds the permissible ex posure limit (Ex. 5A, 4-24). For cost calculation purposes. OSHA has esti mated that 20% of the employees are above the permissible exposure limit, forty percent are between the action level and the permissible exposure limit, and forty percent are below the action level. On this basis first year operating costs are calculated at $526,000, recurring annual costs are calculated at $95,000 and cayital In vestment is estimated to be $420,000. Barges and marine tankers are also used for the transportation of gaso- The r'.'<-*rtbuttcn of these expo sures. however, appear to reembic those encountered during gasoline production and distribution. In that case, the average cost of compliance per employee in his transportation, loading and unloading operations ployee. Laboratories Benzene exposures occur In chemical laboratories where benzene and other petroieum-based solvents are used. Where careful laboratory procedures are followed, such as the use of prop erly functioning hoods and appropri ate work practices, exposures should be very low. In order to estimate the range of possible costs, OSHA calcu lated the cost on the basis of two sce narios. One scenario assumes that 10 percent of the exposed workers are ini tially exposed above the action level but below the permissible exposure level. The second scenario assumes 5 percent of the exposed workers are ini tially exposed above the permissible exposure level. 10 percent are exposed between the action level and the per missible exposure level, and all others are below the action level. On this basis, first year operating costs range from approximately $4.5 million to $10.9 million. Recurring annual costs would be approximately $2.4 million, if all workers exposures drop below the action level after the first year, which Is expected as a result of appropriate controls and w'ork practices. Rubber Products The ADL study examined the poten tial for benzene exposure in plants manufacturing rubber tires and other products, such as belts, hoses, fittings, and coated fabrics. ADL identified 206 affected tire producing facilities em ploying 11.400 exposed workers. The study cited data indicating that expo sure levels were generally in the range of 1-3 ppm and may be considerably higher (ADL. Ex. 5A, pp. 14-19; Tr. 4- 20). Similar testimony was provided by Drs. Tyroler and Harris of the Univer sity of North Carolina based on their studies of benzene exposure in the rubber industry. (Tr. 3083-3095) Both studies indicated that control of expo sure could be achieved, reducing expo sure levels tc below the action level, by substitution of materials and enforce ment of appropriate work practices, and that engineering controls would not be required. (Tyroler, Tr. 3036) Compliance costs were estimated, therefore, on the basis of all exposed workers being exposed initially above the permissible exposure limit, and ex posures reduced to below the action level after controls have been institut ed in tire manufacturing plants. First year operating costs were esti mated to be approximately $15.8 mil lion and recurring annuai costs ap proximately $407,000. ? analysis of firms producing other rubber products was based on the same considerations of workers ex posed and compliance activities. For these firms first year operating costs were calculated at approximately $18.1 million, and recurring annual costs at ------- - - - on 107 laciillies WILii___t-xpujwv, ~ I ' , I' i it-. I H : K l A til' N A I A [ A | | A : k A, I N . A A Ml 1 M . 1 (. N ,(>(.. _`t " . 17 I CURRENT REPORT 1419 may pose or reflect a potential health risk and as such, must be considered tn the larger purview of adverse health effects associated with benzene. V. Economic Considerations In setting standards far toxic sub stances. the Secretary is required by section 5(b)(5) of the Act to give due regard to the question of feasibility. Section 6(b)(5) mandates chat final standards be set which most adequate ly assure employee safety and health "to the extent feasible, on the basis of the best available evidence" and fur ther requires that, in the development of occupational safety and health standards, "considerations shall be the latest available scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws." While the precise meaning of feasibility is not clear from the Act, it is OSHA's view that the term may include the economic ramifications of require ments' imposed by standards. The de termination that OSHA has the au thority to consider economic feasibil ity factors in developing standards has been endorsed by the courts. Industri al Union Dept, AFL-CIO v. Hodgson, 499 F. 2d 46? (C.A.D.C., 1974): AFLCIO v. Brennan. 530 F. 2d 109 (C.A. 3, 1975). As pointed out by the D.C. Cir cuit Court of Appeals, Congress did not intend the Secretary to promul gate standards which drive entire in dustries or large numbers of employ ers out of business. On the other hand, "standards may be economically feasible even though, from the stand point of employers, they are finan cially burdensome and affect profit margins adversely: further, the Court said, the concept of economic feasibil ity does not "necessarily guarantee the continued existence of Individual employers." Industrial Union Dept, AFLr-CIO v. Hodgson, supra, at page 478. In accordance with the Secretary's position, it has long been OSHA's practice to analyze the economic feasi bility of proposed standards where sig nificant economic impact on employ ers covered by the proposals seem likely, to make such analysis available to affected parties for comment and subsequent hearing prior to issuance of final rules, and to invite the submis sion of other information on the eco nomic Impact and feasibility of pro posed standards. In developing a final standard, therefore, OSHA evaluates the economic feasibility of the final standard on the basis of the informa tion developed by its own studies of the proposal and submissions by the public during rulemaking. To assess the economic feasibility of the proposed standard for benzene, OSHA undertook an extensive study of the prc'c^al's economic impact on various affected Industries. This study was conducted for OSHA by Arthur D. Little. Inc. (ADL). (Ex. 5A. 5B). The ADL study has provided basic eco nomic data for the evaluation of the economic Impact of the permanent benzene standard on the major affect ed industries. Additional information for this purpose was obtained through OSHA s analysis and consideration of all other economic data, comments, ar guments and testimony submitted at the benzene hearing, in pre-hearing comments and in post-hearing com ments and briefs. On the basis of the best available evidence, therefore. OSHA has determined, as explained In detail below, that the permanent ben zene standard is economically feasible. Compliance Costs Estimates of total costs of compli ance with the permanent benzene standard for the major affected indus tries studies are as follows: First year operating costs for all Industries com bined are estimated by OSHA to be approximately in the range of $187 million to $205 million recurring annual costs are estimated at approxi mately $34 mfllion and investment in engineering controls is expected to be approximately $266 million. Estimates of these costs for various individual in dustry sectors are analyzed below. As that analysis reveals, the greatest eco nomic impact of the standard falls on the larger and more stable Industries, such as petroleum refining and petro chemical production, which can read ily absorb the costs or shift them for ward to consumers. No testimony was offered by these industries that the proposed standard for benzene would imperil their existence. Even the higher projection of some costs by the American Petroleum Institute and other participants would not raise any serious question concerning the eco nomic feasibility of the standard or the ability of the regulated Industries to bear the additional costs. The benzene standard. In Its final form will require all industries that produce or use benzene, petrochemi cals. products and services involving the use of solvents derived from petro leum. as well as production of crude and refined petroleum products, and primary distribution of gasoline, to un dertake an initial determination of the extent to which their employees are exposed to benzene. The results of the initial exposure measurements will de termine the types of activities each firm will be required to take to comply with the provisions of this standard. Where exposure measurements are below the action level (0.5 ppm), firms will have to provide information and training in the hazards related to ben zene to their employees, comply with the labelling requirements, and retain the records of Initial measurements. These compliance activities account for the entire first year operating costs for many of these industries, Firms with exposure levels above the action level will incur additional first year costs for monitoring and medical examination programs. Finally, those firms with exposure levels above the permissible exposure level will have additional first year costs for Installa tion of appropriate engineering and work practice controls, and for respira tors. It is assumed that engineering controls are all Installed in the first year and reduce exposure levels to below the permissible exposure limit. However, those firms with continuing exposure measurements above the action level will have recurring annual costs for monitoring and medical sur veillance. Regardless of the airborne exposure measurements, employees in operations with potential exposure to eye or repeated skin contact will have to be provided with appropriate per sonal protective equipment. Thus, some firms and industries will have higher and more sustained cost bur dens than others. OSHA's estimates of costs for com pliance with the final standard differ from estimates of the proposal's com pliance costs in part because the stan dard in Its final form differs from the proposal in areas which significantly impact on the cost of compliance. ADL estimated the proposal's compliance costs for 20 Industry sectors engaged in benzene production (petroleum and coke), petroleum refining, chemical processing, benzene transportation, and other industries, such as rubber manufacturing and laboratories (ADL, Vol. 1, Ch 5). ADL provided detailed cost estimates for each industry and for each compliance activity required by the proposal. Total costs for all sur veyed Industries were estimated by ADL as follows: First year operating costs were approximately $124 million, recurring annual costs were approxi mately $74 million, and costs for Im plementation of engineering controls were approximately $267 million. In developing each of these estimates, ADL used the control with the least cost as the basis of their calculations. In other words, where alternative methods of compliance are available to employers in an industry, and indeed may be more attractive to employers, the higher cost method was considered an optional process Improvement, and only that portion of its total cost re quired to produce compliance was allo cated to compliance with the proposed regulation (ADL. Vol 1, pp. 5-3). Addi tionally, ADL assumed compliance with the previous OSHA regulation (29 CFR 1910.1000, Table Z-2) requir ing an exposure limit of 10 ppm TWA and a ceiling limit of 25 ppm, thus as sessing to the benzene proposal only the Incremental cost associated with , Till. :iu k'l-l.VJ >;[' N A r IO N A J. A I- ! A ! U',, INC.. It'.A 11N C. IV N , DC. 2 :))) 7 MCD 00019248 CURRENT REPORT 1415 the iatency periods also reported. universally accepted by Investigators. genic agents. (Ex. 2-40). A slight in However, Pomi and Vigliani have In his testimony. Shaw stated that crease in the percentage of granulocy noted that, occasional cases of acute there was no way to determine who is tic leukemias was observed in the ben- leukemia with a long latency period susceptible to benzene and who is not zene-treated mice as compared with may still be observed (Ex.2-50. p. 215) (Tr. 420). And despite "well substanti the controls: however, the authors and Aksoy, while reporting that no ad ditional cases of leukemia among shoeworkers were diagnosed (n 1976, noted that this did not preclude the development of additional cases in the future (Tr. 159).* The question of la tency periods for benzene-induced leu kemias has not been resolved and re quires further investigation. Another area of discussion is the question of identifying individuals who may be particularly sensitive to the hematotoxlc effects (Including the development of leukemia) of benzene. Several witnesses Including industry participants generally expressed the view that there probably were differ ences In sensitivity (Sakol Tr. 228: Shaw Tr. 412; Snyder Ex. 54.2. p. 25, Thorpe. Eckard Tr. 2052; Furst Tr. 1791-42). It appears from the evidence that there are individuals In given populations who may, because of ge netic factors and/or concurrent or prior exposure to other environmental agents, be especially sensitive to ben zene-induced blood disorders. Aksoy and his colleagues reported a possible familial link in benzene-in duced leukemias in 5 of 40 workers in dicating a possible genetic predisposi tion to benzene's harmful effects (Ex. 60, pp. 8-10). Also, Jandl on the basis of tentative data has attempted to identify a subpopulation with risk fac tors predisposing to Increased sensitiv ity to benzene (ORC/Jandl, PC 34. pp. 43-44). These include; a. Those between the ages of 16 and 30; b. Those with prior exposure to ben zene or exposed to radiation in excess of that required for diagnostic pur poses, and; c. Those with evidence of a history ated information" concerning the in creased sensitivity of certain groups to benzene, the International Workshop was unable to develop and provide spe cific guidelines on this matter (Ex. 17, D. 7). These sensitive individuals, inter spersed among the working popula tion. are certainly among those who are at hfghest risk of material impair ment from benzene exposure. The size of this group is unknown. It is the pur pose of this regulation (especially the permissible exposure level and de tailed medical surveillance protocol) to not only minimize harmful effects of benzene exposure, but also provide early diagnosis and treatment should such effects occur. c. Animal studies. The wide variety of non-malignant hematological disor ders observed in humans exposed to benzene which range from simple anemia, and leukopenia to aplastic anemia have been experimentally in duced in animals. However, attempts to demonstrate the development of leukemia in animals exposed to ben zene has met with less success. Until recently, a study by Lignac in 1932 was the only animal study known to OSHA In which leukemia has been observed in animals exposed to benzene. (Ex. 238). Fifty-four mice (28 females; 26 males) were given subcutaneous Injec tions of benzene (0.001 ml in 0.1 ml of olive oil) for 17 to 21 weeks. Nine mice were initially excluded following intercurrent infection and an additional 12 were lost through atrophy of various organs, especialiy the spleen. Lignac attributed these 12 deaths to the size to the dose of benzene. Eight of the remaining 44 mice developed leukemia or Kundrat's lymphosarcoma and died 4 to 11 months after receiving the first injection. The absence of concurrent controls makes interpretation of the viewed the increase as not statistically significant. In a letter transmitted Aug. 9. 1977 to Eula Bingham. Asst. Secretary of Labor. Nelson described preliminary results of an Inhalation experiment using rats and mice (Ex. 178). Animals were exposed to benzene vapors 6 hours per day. 5 days per week for up to 2 years. Two possible leukemias were observed in a group of 40 strain CD mice exposed to 300 ppm. In one animal, elevated WBC counts were ob served 193 days after exposure, with death following 3 days later. The au topsy findings were consistent with CML. a disease not known to arise spontaneously in this strain. The second mouse exhibited the presence of abnormal blast forms in the periph eral blood after 211 days of exposure and died 4 days later. Whether this finding indicates AML, a disease previ ously ohserved in this strain, or acute lymphoblastic or stem cell leukemia (spontaneous Incidence about 4 per cent) had not been resolved at the time the report was submitted. One of the 40 rats exposed to 100 ppm benzene developed an elevated WBC count after 240 days of exposure with the cell counts continuing to in crease slowly. Peripheral blood smears showed some Immature neutrophils. This finding Ls compatible with a diag nosis of CML, a disorder which is rela tively rare for the rat. However, a non leukemic leukemoid process could not be excluded. Nelson characterized the results of the study as: slender evidence of the production leukemia. Nevertheless, despite the shakiness, we believe these results to be extreme ly suggestive and provide an urgent basis for Intensive further study (Ex. 178). of other less severe myeloproliferative disorders such as remitted aplastic anemia, certain abnormal circulating blood cells, or those with persistent abnormalities in one or more blood cell types. results problematic and uncertain. Failure to identify the mouse strain studied has frustrated efforts to Inde pendently confirm the findings. Other studies have failed to repro duce Lignac's results. Amiel in 1960 D. ConcfustoTis. Leukemia is a seri ous world-wide problem. In this coun try alone, approximately 20,000 adults die annually from this disease, and about 12,000 individuals develop and die from AML each year (ORC/Jandl, Other predisposing factors may in utilized four inbred strains of mice and P.C. 34, p. 72). However, based on the clude exposure to drugs or alcohol subjected them to the same experi published literature the number of which may act to modify the metabo mental program outlined in Lignac's AML deaths attributable to benzene lism of benzene. These postulated ef study. (Ex. 2-39). No leukeri? or exposure is unknown, in this regard. fects are not consistently observed or aplastic liemopaihies were observed. Goldstein states: "The incidence of Ward et al. administered benzene sub leukemia appears to be a small frac *A 3hon latency resulting from high ex posures Is another possible explanation. cutaneously to a strain of mice which tion of all benzene-induced hematois known to be responsive to leukemo- toxicity." (Ex. 54.B, p. 160). One rea- ( *-- MCD 000019249 PviohshL-W l.y Tl IK HUKK.UJ OF NA I'I ON' A l. A CK A IKS. INC . WASH INI'. TON , DC. .20037 CURRENT REPORT 1411 ficiaily because the families refused permission to release the names of the decedents for fear of loss of compensa tion and job. This testimony indicates an underestimation of the leukemic risk among Pliofilm workers. Based on the hypothesis that the risk of leukemia was higher among workers who were exposed to benzene and medical X-rays, Ishimaru et al. conducted a retrospective epidemiolog ical investigation examining the rela tionship between occupation and envi ronmental factors, other than A-bomb exposure, and the incidence of leuke mia in Nagasaki and Hiroshima be tween 1945 and 1967 (Ex. 2-33). Fif teen occupations were selected in which there had been exposure to either medical X-rays or solvents, es pecially benzene and its derivatives. This case-control study compared all cases diagnosed as definite or probable leukemias between 1945 and 1967 and residing at the time of the onset of the disease, in Hiroshima or Nagasaki. Controls were matched for city, sex, date of birth (30 months), distance from the atomic bomb explosion, and residence in either city at the onset of disease. Four hundred ninety-two leu kemia cases were identified, and matched controls were obtained for 413. Three hundred and three adult cases with the onset of leukemia at age IS years or over and their controls were compared. The risk of leukemia was found to be significantly higher (about 2.5 times greater) among those with a history of employment in occu pations in which various volatile sol vents were used as compared to those without. The relative risk was 1.8 times higher for chronic leukemia and 2.9 times higher for acute. Eighteen of the leukemia cases associated with sol vents were located in distant and nonexposed radiation areas and were con sidered too far from the A-bomb ex plosion for radiation to have enhanced the increased risk. Accepting the source of error inherent in the method which was used to collect the data, the results of this study nonetheless rein force the observation that an increase in leukemia existed in that portion of the population exposed to radiation and employed in an occupation where solvents especially benzene, were used. In 1970, Girard et al. published an epidemiological study (Ex. 2B-283) un dertaken to determine previous expo sure to benzene or toluene in 401 pa tients suffering from malignant hemopathies. Extensive interviews about work onvlroruuw..'. J rr.icai analyses of solvents were utilized to es timate exposure. Their findings dem onstrated that compared to a control group admitted for non-hematologlcal diseases there was a statistically sig nificant greater frequency of past ex posures to benzene or toluene among subjects with aplastic anemia, chronic lymphocytic leukemia and acute leu kemia. In April 1977. NIOSH submitted to OSHA a preliminary report by Infante et al. of a study of leukemia among benzene-exposed workers employed in the production of natural rubber cast film (Pliofilm) (Ex. 2-57. Ex. 2A-271). The study included all white males assigned to the Pliofilm production area who were hourly employees and who at any time between January 1. 1940 and December 31, 1949 had direct exposure to benzene at the Goodyear Akron and St. Mary's plants. Only the men employed in a section having known potential exposure to benzene ("wet side" in Industry terminology (Rlnsky. Tr. 818-820)) were Included in the cohort. Men employed in the Plio film operations, but not in production jobs (so called "dry side" workers) were not included In the study. Follow-up of vital status was attempt ed from termination of employment to June 30. 1975 and was achieved for 75% of the total of 748 benzene-ex posed workers. So as not to overesti mate the true risk of lymphatic and hematopoietic malignancies associated with benzene exposure, the 25% of the cohort for whom vital status was not determined were assumed to be alive. Little or no quantitative exposure data existed for these plants. Causes of death were determined from death certificates, and person- years at risk were determined by a modified life-table method, personyears of observation and causes of death were determined from January 1. 1950 to December 31, 1975. Two con trol populations were used to generate the numbers of expected deaths in the study. The first comprised the U.S. white male population, while the second was white males employed In an Ohio fibrous glass production facili ty during the 1940's and who had achieved five years of employment by June 1, 1972. The most striking finding was the observation of a statistically signifi cant (p less than 0.002) five-fold in creased risk of dying of leukemia com pared to the U.S. male rates (7 deaths observed vs. 1.38 deaths expected, p less than 0.002), as well as to the fi brous glass workers (7 deaths ob served. 1.48 deaths expected, p less than 0.002). Criticisms of various aspects of this study were raised by participants to the rulemaking. The issue of what level of benzene the workers in the In fante et al. cohort were exposed to was the most discussed area. Participants criticized the information available in the Infante study. The study referred to a November 1946 report of the In dustrial Commission of Ohio which In dicated that: "Tests were made with benzol detectors and the results indi cate that concentrations have been re duced to a safe level, and in most in stances range from 0 to 10 or 15 parts per million." Comments at the hearing demonstrated that there were area ex posures during this study period ex ceeding these levels, at times reaching values of hundreds of parts per mil lion. Since no personal monitoring data are available, any conclusion re garding the actual individual timeweighted average exposure is specula tive. Because of the lack of definitive exposure data, OSHA cannot derive any conclusions linking the excess leu kemia risk observed with any specific exposure level. The study was also criticized for combining the two separate plants in the same analysis. It was suggested that an Independent analysis of the two plants would produce different re sults, thereby suggesting that factors other than similar exposure to a single agent (benzene) contribute to the excess leukemia. (Lamm, Tr. 2538). OSHA believes that the use of non age-adjusted leukemia death rates, as utilized in Lamm's analysis, is Inappro priate for the assessment of an event associated with age. Therefore, OSHA believes that this criticism is unsupportable on this basis. Moreover, the cohorts were combined based on the similarity of the processes in the two plants (Tr. 842). Also, because of the small number of subjects in the study cohort, the authors stated that It would be Inappropriate to analyze the data separately for the two plants. (Infante. Tr. 935, 796-97). A question has been raised by indus try participants as to the validity of excluding the "dry side" (Pliofilm fin ishing) workers from the study cohort (Lamm, Tr. 2638-29: API, PC 33, p. 42- 43). As explained by one of the au thors, those workers were never in tended for inclusion in the cohort fol lowing discussion with compar" oer- sonnei indicating there was no ben zene exposure on the dry side (In- Pvjbhshcij HE HURE.VJ OL NATIONAL AI-KA1KS, INC.. WAS! 11 NO, VON. D C. 20OJ7 CURRENT REPORT 1407 cause respiratory air concentrations of ttte While the literature Is Inadequate to draw abnormalities In 10% of 108 men ex level of the MAC value (15 ppm for ben firm conclusions, the progression and out amined 24 months after exposure zene*. A/ter the workers have been exposed come (fatality rate] of benzene-induced pan ended. (Ex. 141). Helmer observed ab for a sufficiently long time, one must assume that hematological uamage will result. In a recent survey. Aksoy et al. com cytopenias does not appear to differ sub stantlaily from that of published series ol patients with idiopathic aplastic anemia (Ex. 43.B. p. 145).* (Ex. 43.B. p. 148) normalities in 25% of 60 patients fol lowed for 16 months. Including 2 deaths. Rejcek and Rejskova found that 8 of 4500 workers manifested per pared the hematological findings of The NRC report comes to a similar sistent leukopenia 12 years after expo 217 apparently healthy male workers conclusion: sure. (Cf. Hernberg, Ex. 2A-252. p. who were exposed to as much as 210 (Tlhe available evidence does not Indicate 204). Aksoy observed a further distin ppm benzene when adhesives contain that the reported benzene-induced blood dy- guishing feature of severe blood disor ing benzene were utilized (Ex. 2-11). scraslas differ in any way from similar dy- ders resulting from benzene exposure; The duration of exposure ranged from scrasias which are caused by other myelo In over 100 cases of aplastic anemia 3 months to 17 years. Hematological toxic agents or for which the etiology is un classified as idiopathic or associated abnormalities were seen in 23.5% of known (NRC. Ex. 2-4 p. 4). with etiological agents other than ben the workers. Leukopenia, with or with out thrombocytopenia, was the most common finding. In addition, relative to controls, benzene exposed workers were found to have a statistically sig nificant reduction (p less than 0.001) On the other hand, Jandl contends that the high degree of reversibility of benzene-induced non-malignant blood disorders distinguishes these disorders from those caused by other agents which are Idiopathic In nature. He re zene. no cases of leukemia were ob served (Aksoy. Ex. 60, p. 6Ah This con trasts to the development of leukemia among some cases of aplastic anemia associated with benzene exposure. As Is apparent from the above dis in mean white cell and platelet counts. ports that the chance for recovery In cussion, there is no unanimity of opin Aksoy and his colleagues reported a Idiopathic aplastic anemia is 16%. that ion whether benzene-induced blood considerable variability in the 11 bone for drug-related aplastic anemia it is disorders persists, and are reversible marrow specimens studied. The aspi 33% and that based upon a review of after cessation of benzene exposure rates showed both hypocellularity and 169 patients with benzene-induced and whether such disorders differ* hypercellularity (a decrease and an in aplasia reported between the years from those resulting from other crease in the number of cells present), 1939-1975. the prognosis for recovery known or unknown causes. a finding consistent with his previous reports. (See Aksoy et al. Ex. 2A-290). In 33 percent of the workers exam ined, the hemoglobin levels fell below the lower limit of normal. Aksoy was reluctant to ascribe the anemia to ben zene exposure since it was correctable by iron therapy. However, Goldstein commenting on Aksoy's findings that "the mean corpuscular volume (MCV) was in the high normal to slightly ele vated range (80-96 um) which is un usual for iron deficiency and more in keeping with a benzene effect." (Ex. 43B, p. 140). In 1977, Dow reported that 2 of the 594 individuals occupationally exposed to benzene died of non-malignant blood disorders, compared to 0.2 deaths expected (DOW/OH/Ex. 154, is 87%. (ORC/Jandl. Ex. 34. p. 37) Fur thermore. he notes that milder forms of blood disorders resulting from ben zene exposure appears to be 100% re versible (ORC/Jandl. PC 34. p. 39). OSHA is aware that literature indi cates that many cases of nonmallgnant blood disorders may be reversed. For example, Maugert has stated: the hemopathy due to benzol can. as In most cases studied by us. be cured If it Is di agnosed immediately (Maugerl 6c PollLni Ex. 158. I p. 2). Hernberg et al. In a follow-up study of 125 workers stated that: "the prog nosis of these patients proved to be more favorable than might have been expected." (Ex. 2A-252. p. 209). Also, both Tabershaw and Aksoy have noted OSHA recognizes that in many cases these disorders appear to be reversible, within the definitions of "normality" or "reversibility" used by the individ ual authors. However, it is not known whether for particular workers the blood indices actually return to pre-exposed or baseline valves. Because the original' literature does not provide suitable long-term longitudinal analy sis Including adequate sample size, preexposure values nor baseline hema tological values for comparative pur poses on an individual basis, it is diffi cult to decide how much reliance can be placed on such studies. Moreover, the evidence is insufficient to deter mine whether or not Individuals who have "recovered" are at greater risk to subsequent development of leukemia. Table 6). One worker died of perni the reversibility of various cytopenias finally. OSHA is unable to verify cious anemia 4 years after retirement. (Tr. 2547). Jandl's quantitative estimates of re His exposure was estimated to have However, certain other investigators covery as the sources selected for his averaged 30 ppm for approximately report that these disorders have per calculations are not adequately pre 184 months. The second employee, sisted for as long as 12 years after ces sented to permit the development of who died of aplastic anemia, had an sation of benzene exposure. Goldwater valid inferences. Consequently, the estimated exposure of 5 ppm for ap and Tewksbury noted continued blood Agency does not believe it appropriate proximately 98 months. Because- of to conclude that these non-malignant the small numbers Involved, the sig blood disorders will in all cases, be re nificance of Dow's findings is subject to some questton, but the trend of excess death is consistent with the evi dence presented above. An issue deserving discussion is the similarity and difference between ben zene-induced non-malignant blood dis orders and those resulting from other causes. In the NYU report. Goldstein noted that: However, Goldstein does suggest three passible differences between benzene-in duced pancytopenia and so-called Idiopathic aplastic anemia: the first Is the observance of marrow hyperplasia in benzene-induced disease; the second Is the presence of lym phocytopenia; and the third is "relatively frequent but Inconsistent" reports of red blood cell macrocytosis resulting from ben zene exposure, (Ex. 43.B, p. 148) versed to the individual's normal values. b. Animal Studies. One of the first studies describing experimentally in duced benzene toxicity was published by Selling in 1916 (Ex. 2-12). He was able to produce both destructive r.nd "regenerative" effects in rabbits by subcutaneous injections of commer- oO' o' o sP RK.VJ OF N.A Til -N AL A l r AIRS. I MI., WAS!!! N '.iTON , DC. 20037 CURRENT REPORT 1403 rary standard was published on May 24. 1977 (42 CFR 26429). The evidence and findings supporting Issuance of the emergency temporary standard and its amendment and a discussion of Its provisions are set forth in the aforementioned Federal Register puolications. The emergency tempo* rary standard was to have been effec tive on May 21. 1977. However, as a result of challenges to that standard, filed both In the Court of Appeals for the District of Columbia (.Industrial Cnion, AFL-CIQ v. Bingham, No. 77- 1395) and in the Court of Appeals for the Fifth Circuit (API v. OSHA, No. 77-1516), a temporary restraining order was Issued by the Fifth Circuit on May 20, 1977. and the standard never officially went into effect. On May 27, 1977, OSHA published a proposed permanent standard to con* trol occupational exposure to benzene (42 FR 27452). The emergency tempo rary standard and Its preamble, which the new proposal supplemented, were Incorporated in that proposal. The Federal Register document setting forth the proposal also contained a notice of hearing scheduling an Infor mal public hearing to be held pursu ant to section 6(b)(3) of the Act. and requesting the submission of written comments, data, views and arguments on all the issues raised by the pro posed permanent standard and the emergency temporary standard. Sub sequently. on June 24. 1977 (42 FR 32267), OSHA excluded from the scope of the benzene hearing and from the final permanent standard those activi ties related to the storage, transporta tion. distribution, dispensing and sale of gasoline as a fuel subsquent to its discharge from bulk terminals. OSHA explained in that notice its intention to assess the regulatory action to be taken to protect workers involved in these activities after conclusion of the deliberations of a Joint EFA-NIOSH- OSHA Task Force. The public hearings on the benzene proposal were held July 19 through August 10, 1977. A total of 95 individ uals appeared at these hearings as wit nesses. Among the witnesses were em ployers and employer associations from a variety of Industries: petroleum refining, petrochemical, oil and gas production, aviation fueling; and coke ovens and coke by-products. In addi tion. representatives of the affected workforce, including a number of em ployees who have been exposed to ben zene, unions, government agencies, public interest groups and other inter ested parties appeared. Furthermore, comments were received from repre sentatives of other industries, such as analytical and research laboratories, paint manufacturing, construction, maritime, and rubber manufacturing and from users of pure benzene as well as users of benzene contaminated sol vents. Public participation was repre sentative of a large segment of the benzene users. The verbatim tran script of the hearings, as well as the numerous comments, exhibits and briefs submitted to OSHA before, during and after the hearings, are part of this rulemaking record, along with other relevant documents. The hear ing record was originally scheduled to close on August 20. 1977 but, at the re quest of industry participants, the record was kept open until September 2, 1977 for the submission of addition al evidence and until September 27, 1977 for the submission of briefs, sum maries and arguments. In conjunction with the develop ment of the proposed standard. OSHA prepared a draft environmental Impact statement. The draft environ mental statement was published in the Federal Register (42 FR 27455). On June 17, 1977, the Council on Environ mental Quality published a notice of availability of the benzene draft envi ronmental Impact statement (Ex 7). In addition to the 45 day comment period specified In 29 CFR 1999.4(g), the envi ronmental impact of the proposed standard was also an Issue for the ben zene hearing as provided by 29 CFR 1999.4(h) and the notice of proposed rulemaking (42 FR 27452). A notice of availability of the final environmental Impact statement for benzene was published on February 3. 1978 by EPA (43 FR 4074). In addition to the draft environmen tal impact statement, OSHA prepared an economic and inflationary impact assessment of the proposed standard evaluating factors relevant under sec tion 6(b) of the Act (29 U.S.C. 655 (b)(5). Secretary of Labor's Order 1575 (40 FR 54484) and Executive Orders Nos. 11821 (39 FR 41501) and 11949 (42 FR 1017). The notice of the pro posed standard indicated that the eco nomic Impact of this proposal was to be considered at the hearing (42 FR 27452) and certified that the economic and inflationary impact of the pro posed standard has been carefully evaluated in accordance with Execu tive Orders 11821 and 11949. This permanent benzene standard Is based on a careful consideration of the entire record in this proceeding, in cluding materials relied on in the emergency temporary standard, mate rials referenced in the proposal, and the record of the informal rulemaking hearing including the transcript, ex hibits and pre-hearing and post-hear ing written comments. Copies of the official list of hearing exhibits, com ments. and notices of Intent to appear at the hearing can be obtained from the Docket Office. Docket H-059. Room S6212, U.S. Department of Labor. 3rd Street and Constitution Avenue NW,, Washington. D.C. 20210. III. Pertinent Legal Authority The primary purpose of the Act Is to assure, so far as possible, safe and healthful working conditions for every working man and woman. One means prescribed by Congress to achieve this goal is the authority vested in the Sec retary of Labor to set mandatory safety and health standards. Occupational safety and health stan dards provide notice of the requisite conduct or exposure level and provide a basis for assuring the existence of safe and healthful workplaces. The act provides that: The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately as sures. to the extent feasible, on the basis of the best available evidence, that no employ ee will suffer material Impairment of health or functional capacity even if such employ ee hss regular exposure to the hazard dealt with by such standard for the period of his working life. Development of standards under this subsection shall be based upon research, demonstrations, experiments, and such other information as may be appropri ate. In addition to the attainment of the highest degree of health and safety protec tion for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws. (Section 6(b)(5).) Sections 2(b) (5) and (6), (20). (21), (22). and (24) of the Act reflect Con gress' recognition that conclusive medical or scientific evidence includ ing causative factors, epidemiological studies or dose-response data may not exist for many toxic materials or harmful physical agents. Nevertheless, standards cannot be postponed be cause definitive medical or scientific evidence is not currently available. Indeed, standards need only be based on the best available evidence. The legislative history makes it clear that "it Is not intended that the Secretary be paralyzed by debate surrounding di verse medical opinion." House Com mittee on Education and Labor, Report No. 91-1291. 91st Cong., 2d Ses sion. p. 18 (1970). This Congressional o -0 Published by THE UUKE.VJ C>K SATIONA AIT AIKS. INC .. '* \SI UN< ,T( IN, DC 20.1 J7 CURRENT REPORT 1445 sible exposure limit. It is likely, how ever, that there will he many employ ees who work In the regulated areas for such periods of time or at such levels of exposure that they would without respirators be exposed to well above the permissible exposure limit. Por this latter group, respirators woqjd be required to reduce their ex posure levels. To assure that these em ployees are adequately protected, it is necessary that the sign alert them to the need to wear respirators. More over, since even persons who are in a regulated area occasionally and are not exposed over the permissible expo sure .limits may face an increased risk of leukemia. OSHA does not believe that the respirator warning is such an overstatement as to necessitate elimi nation of that warning from the sign. One comment pointed out that the warning sign ignores the flammability of benzene (Com. 50). NTOSH also rec ommended that the potential danger for fire be displayed on signs with equal prominence with the toxicologi cal hazards. (Tr. 7S5) OSHA agrees. Benzene, as has been stated. Is a highly flammable liquid. Accordingly. In the final standard. OSHA has added a requirement that the signs also con tain the legend "Flammable--No Smoking" with equal prominence to the legend "Cancer Hazard." Labels. The standard requires the use of caution labels on all containers of products containing any amount of benzene. This requirement Imposes upon the employer the obligation to assure that all such containers within his workplace are at all times properly labeled. Some industry comments re quested that OSHA define "container" (Com. 46, 55, 65) in terms of sizes and types of containers (Com. 53; Com. 72). Participants also appeared to be confused as to whether storage tanks, pipelines, tank cars and tank trucks are such containers as would be re quire labeling (Com. 60). The purpose of the labeling requirement ts to assure that, wherever benzene Is pre sent in any quantity, employees are apprised of the hazard. The size or type of the container or its use as a storage vessel Is. therefore, not materi al to this objective. In Imposing the la beling requirement, however, OSHA does not intend to include pipelines, or to include trucks or other vessels transporting benzene products in sealed containers. At many points of pipelines, there is no employee expo sure nor can the point at which ben zene enters a product stream often be determined. Benzene in liquid mix tures. other than in gasoline, Is often transported in closed containers, In which case labeling of the container is sufficient without a need for labeling the transport vehicle. Where benzene products not in containers are trans ported in barges or other tank vessels. such as tankers and tank trucks, It is. of course, necessary that the vessel be labeled. With regard to gasoline, the standard does not cover activities past the bulk terminal and, therefore, gaso line trucks would not require labelling. In view of the above, the standard spe cifically excludes from the labeling re quirements pipelines and any trans port vessels or vehicles where the ben zene product is transported in sealed containers. Some participants suggested that the labeling requirements apply only to containers which have liquids with greater than 1% benzene (Com. 53, 72). It was also suggested that labels be affixed only to containers from which exposure to benzene levels above the permissible exposure limit might be reasonably expected to occur so as to exclude a requirement to label finished products which might contain trace amounts of benzene (Com. 59). Since there is no known safe level of exposure to benzene. OSHA feels that, for employees to be adequately ap prised of the hazard, all containers must be labeled In the same manner. The standard requires that the cau tion labels remain affixed when ben zene products leave the employer's workplace. Some comments questioned OSHA's Jurisdiction to impose such a requirement (Com. 50, 55, 59). The purpose of this requirement Is to assure that all employees, not only those of a particular employer, are ap prised of the hazardous nature of ben zene exposure. It Is OSHA's view that informing employees of the hazards to which they are exposed Is an impor tant element In reducing occupational disease and injury and one of the sig nificant purposes of the Occupational Safety and Health Act. Section 6(b)(7) of the Act, which explicitly provides for regulation requiring the use of labels or other appropriate forms of warning to apprise employees of the hazards to which they are exposed. Is broadly drawn. This section does not limit the employer's obligation of in forming employees of hazardous con ditions to the employer's own employ ee. When an employer manufactures, formulates or sells a product contain ing a toxic substance, that employer is exposing not only his own employees but also the employees of other em ployers involved in handling, trans porting or using the product. The extent of the obligation to inform should be commensurate with the extent of the exposure. This is espe cially true where the manufacturer, formulator or seller will in many cases be the only employer capable, through his unique knowledge, of providing the information needed for protection of employees. A narrower reading of the statutory authority would defeat the protective purposes of the Act by withholding from employees down the line who come Into Any contact with the product, adequate Information as to the hazard. Furthermore, the use of the labels will alert other employers, who utilize or handle the product and who would not otherwise know of the presence of benzene in their work place, of their obligation to comply with the standard. OSHA. therefore, feels that this requirement is neces sary and appropriate to effectuate the purposes of the Act. The standard prescribes the legend that must be Included on the label. This is to assure that employees are alerted to the fact that they are han dling benzene and to the hazard in volved. The record evidence estab lishes that a variety of code names have been used for benzene (Ex 61, Sakol) and that employers (Tr. 3383; 3516), workers (Tr. 3402) and physi cians (Tr. 305-6) often do not know that the product contains benzene. Some participants suggested that labels state the percentage of benzene in the product (Com. 56. 21. 59). In order to keep the label information to a minimum and since there is no con sistent predictable relationship be tween the amount of benzene in the product and the percentage level, the final standard does not require any such statement on the label. Recordkeeping and reporting. The provisions for recordkeeping, report ing, availability of records and the transfer of records are similar to those In the proposal. Such changes as have been made In the final standard are In response to the request of public par ticipants that OSHA reduce the burden imposed by these types of re quirements. These provisions imple ment the requirements of section 6(c)(1) and (3) of the Act, and are con sistent with OSHA's general policy concerning records and reports. Records: paragraph (I) The standard requires a limited amount of record keeping. Employers must maintain ex posure measurement records and medical records. The need for keeping these records was generally accepted by the partici pants in the benzene rulemaking. The common purposes of these recordkeep ing requirements Is to assure the em ployer's compliance with the control measures designed for the protection of his employees, and to collect data vital to epidemiological and diagnostic Investigations In order to resolve such questions as dose-response relation ships In blood diseases caused by expo sure to benzene. Furthermore, these records are useful for the employer by enabling him to Identify areas of his operations where there is or may be a problem. Exposure measurement re cords assist in pinpointing those pro cesses or operations which require ad ditional efforts to reduce exposure to benzene. Medical records provide an by THE OUKEAU Ot-' NATIONAL AKl-'AIHS. INC.. WASHINGTON. D.C. 200J7 CURRENT REPORT dard. (Com. 55.) OSHA. however, be lieves that the likelihood of eye or re peated skin contact and the resultant need for protective clothing must be assessed on the basis of Individual workplace operations. One comment objected to the need for protective clothing or equipment where, 1 percent or less benzene Is present in the liquid benzene. There is. however, nothing to Indicate that such percentages would create a sufficiently reduced hazard to warrant total elimination of the re quirement. The final standard requires the use of "impermeable" protective clothing and equipment. This requirement was in the emergency temporary standard. The proposal, however, would have simply required "appropriate protec tive clothing and equipment." Where eye and skin protection are required, the protective clothing and equipment to be "appropriate" must not allow liquid benzene to reach the eyes or skin. To make this clear. OSHA has adopted the language of the emergen cy temporary standard. The imperme able clothing must prevent all penetra tion of benzene. Thus, where imper meable gioves are used, liquid benzene should not seep through the cuff or any other opening in the glove. This could very well increase the hazard to the employee. It appears, on the basis of testimony from the industry expert witness, that, when a chemical sub stance ori the skin is covered with a to tally inclusive material, the rate of permeability of the substance through the skin is greatly increased (TR 2464; 2473). Hygiene Facilities Although normally required in car cinogen standards (See Coke Oven and Cancer Policy), the final benzene stan dard does not contain any requirement for hygiene facilities, such as waste disposal, housekeeping, showers, change rooms, or laundering of cloth ing. The question of what, if any, hy giene facilities should be included in the final standard was at issue in the benzene rulemaking proceeding. The most common view of participants In that proceeding was that hygiene fa cilities were not necessary because of the volatility of benzene (L.C. 19). Almost all participants felt that no hazard would be created by the ab sence of hygiene facilities. One wit ness, however, testified that, in his opinion, the wife of a benzene exposed employee, who laundered her hus band's work clothes daily died from benzene induced leukemia (Tr. 314). Unfortunately, no further information concerning this case was furnished. OSHA, consequently, finds that the record does not establish the need for a requirement for hygiene facilities. Medical surveillance: paragraph it). This standard requires that employers make available a medical survelllence program for those workers who are ex posed to benzene at or above the action level of 0.5 ppm TWA. In addi tion, the regulation contains an emer gency provision for the biological mon itoring of employees exposed to a mas sive release of benzene. Evidence contained in the record clearly Indicates that a medical surveillence program is an appropriate measure. Hematologists, company physicians and other participants have recommended the inclusion of a medi cal surveillence provision In the final standard (Ex. 106; P.C. 30: Ex. 211: Ex. 17, Ex. 179, Bommarito, TT. 3332). Also, a review of the record discloses that it is a current commmon practice of many industries to routinely exam ine their employees for evidence of benzene toxicity, (e.g. Wodka. Tr. 1263: Com. 26; Joyner. Tr. 2286; Dow, Tr. 2967. 3021: Ex. 77H.) Section 6(b)(7) of the Act requires that employers make available medical examinations to ascertain whether the health of workers is adversely affected by exposure to toxic substances, where appropriate. The requirements con tained in this regulation are designed to detect changes In the hematopoietic system resulting from chronic expo sures to benzene which may be mani fested in a range of blood disorders, in cluding leukemia. It is widely recognized that the major target organ in chronic benzene toxicity is the hematopoietic system, especially the bone marrow. This system has the attribute that a sample of the peripheral blood offers a unique biological "window" on the function ing and health of this system, provid ing much direct visual information not readily available for other organs or systems. It Is OSHA's view that a medical sur veillance program directed toward the early detection of hematopoietic dys function by examination of peripheral blood samples Is an appropriate mea sure. This determination receives sup port from: (1) Studies showing that early blood dyscraslas have been de tected In workforces screened by labo ratory tests (and often in workers dis playing no obvious physical sympto matology) (Greenburg, Ex. 2-8. p. 419: Savilahti. Ex. 2-95. p. 1; Goldstein. Ex. 43B, p. 138): and (2) that even in cases of acute myelogenous leukemia, a period of remission, unfortumately brief, may be effected In a substantial proportion of those afflicted with this fatal disease by appropriate treat ment. (ORC/Jandl. P.C. 34. p. 73-74). OSHA's decision Is also supported by evidence that some cases of benzeneinduced blood disorders may be re versed upon cessation of exposure and by appropriate treatment. (ORC/ Jandl. P.C. 34. p. 39). The medical surveillance provision of the proposed standard was the object of much comment and testimo ny. For example, over 45 separate comments addressed this issue in prehearing submissions alone. Additional ly, substantial testimony was adduced during the hearing, and additional views were submitted to OSHA in the form of post-hearing comments. These suggestions addressed both the con tent and frequency of the examina tions as well as what information should be elicited from the medical/ work history portion. OSHA, in formulating the provisions of the medical surveillance section, was aware of several problems. While there is no disagreement that the blood tissues are the most important organ relative co chronic benzene tox icity, there are as yet no consistent patterns of abnormalities, especially at low exposure levels, and no specific pathognomonic tests of benzene toxic ity (Rosen, PC 23A, p. 2). Compound ing this problem is the fact that it is difficult to separate cases of early ben zene hematoxicity from more common minor blood disorders (Goldstein, Tr. 354). Associated with the problems of exam content Is one of testing fre quency. There are simply no precise estimates of the time course of the various abnormalities to allow deter mination of optimal testing frequency. Opinions based upon the lifespan of the blood cells are equally inapplicable in determining the frequency of such exams (Battle. P.C. 260. While realiz ing that the more frequent the exams the greater the probability of detect ing blood disorders induced by ben zene. OSHA is also aware of the prac tical considerations of a medical sur veillance program. Unlike the coke oven standard which applies to a de fined number of workers employed in well characterized work sites, benzene Is a component (usually as a contami nant) of a wide variety of refined pe troleum solvents and. therefore, some benzene exposure occurs In a myriad of work sites and work operations. OSHA also recognizes that to be effec tive a medical surveillance program must be acceptable to a majority of workers subjected to the examination, the tests must display a high degree of accuracy and reproducibility, and the program should be able to be per formed in a routine manner without unduly taxing medical resources. Given the above facts, the prescribed medical surveillance program is de signed to accommodate the purpose of detecting early blood disorders result ing from benzene exposure without being overly burdensome and unduly intrusive. The medical surveillance program consists of three main elements: (1) An Initial and periodic examination for all those employees exposed to airborne benzene concentrations at or above the action level, (2) evaluation of ab- ( mod 000019254 I liy I I [ I. HI I HI'. \u ( ! A J U I-; A i A fl A IK',, INC., A A'-i ilNC. I < >N, H.C. J0<) '7 CURRENT REPORT 1447 cords of Individual exposure by desig nated representatives could result in a denial of access to the information by the employee where he is Incapacitat ed and unable to Inspect the records or simply not able to understand them. This would defeat the purpose of the availability provision which is to assure current employees that their exposure is properly monitored and assure former employees of access to Information necessary for the contin ued protection of their heatlh. Fur thermore. the Act recognizes (sections 2<bX13>; 8(c)(3); 8(f)(1)) the legitimate role of employee representatives in oc cupational safety and health. One In dustry comment suggested that em ployee representatives be formally des ignated in writing and that access to records also be requested in writing (Com. 15). OSHA does not deem It nec essary to include such a requirement In the standard, but employers may es tablish procedures for access to re cords so long as the procedures do not restrict the employees' and former em ployees' to access. The standard also requires that medical records also be made avail able, upon request, for examination and copying to the designated physi cians or representative of both current and former employees. Some com ments questioned the fact that the standard enables not only the employ er but also the employee and his rep resentative and OSHA and NIOSH to have access to medical records without specifying confidentiality or otherwise limiting circulation of the Information (Com. 26, 48). OSHA recognizes that a physician's records may contain a wide range of personal and medical infor mation deemed to be confidential or private. For this reason, the standard limits the contents of the medical record to such information as is relat ed to benzene exposure. Indeed, the standard requires In paragraph (1) (8) (ii) that the employer advise the phy sician that the physician's opinion, which becomes a part of the medical record, should not reveal findings or diagnoses unrelated to occupational exposure. The need of the employer, the employee and OSHA and NIOSH to have access to this information has already been thoroughly discussed. Disclosure of the information to other persons is, of course, subject to protec tive requirements of any applicable laws or regulations. To assure that the records will be preserved for the required retention period of forty years, the standard re quires an employer, who ceases to do business, to transfer his records to his successor and, in the event that there Is no successor, to transfer the records to the Director of NIOSH. One indus try comment suggested that this sec tion be deleted. (Com. 59). Allowing employers to dispose, at will, of the re cords of exposure measurements and medical surveillance would result, more often than not, in destruction of these records thus depriving employ ees of information necessary for evalu ation of their health, as well as depriv ing NIOSH of information valuable to Its scientific investigations. Another participant suggested elimi nation of the requirement that the re cords be transferred to NIOSH by reg istered mail. (Com. 68). OSHA has adopted this suggestion and the per manent standard eliminates the re quirement to use registered mail. Reports. Paragraphs (d)(3), (e)(5), (f)(2), (i)<4)(i). The standard imposes notification requirements upon em ployers. This requirement is discussed above under Regulated Areas. The standard also obligates the em ployer to give certain Information to employees. The employer must notify each employee of the exposure mea surement representative of his expo sure. This notification must be made regardless of what the exposure level of the employee is. Two comments suggested that availability of exposure records was sufficient to inform em ployees of the results of their monitor ing (Com. 46 Com. 53). Several com ments suggested that the notification be required only where the employees' exposure is above the permissible ex posure level (Com. 10. 15. 21. 41, 46, 53. 59) and that exposures below the per missible level be available to the em ployee upon request (Com. 10). OSHA believes that, consistent with section 8(c)(3) of the Act, every employee has the right to know what his exposure level is and whether it is above or below the permissible exposure level. Moreover, since the permissible expo sure level is a feasibility level and not a "safe" level, the employee must know, for proper evaluation of his health by a physician tn the present and future, the level of benzene to which he Is exposed. Accordingly, the suggestions to modify the employee notification requirements have not been adopted. The standard further requires that, where the employee's exposure Is over the permissible exposure level, the em ployer must also state In the notifica tion what corrective action the em ployer is going to take to reduce the exposure level. This is necessary to assure employees that the employer is making every effort to furnish them with a safe and healthful work envi ronment, and implements section 8(c)(3) of the Act. Notifications to employees of their exposure levels must be made In writ ing. Several comments objected to this requirement. Some comments suggest ed that the employer be permitted to notify employees by posting of a notice on the workplace bulletin board (Com. 15. 49. 59), thus relieving the employer of the burden of notifying each and every employee. It is OSHA's view that direct notification to each employee Is necessary tn order to assure that the employee, as required by section 8(c)(3) of the Act. is ap prised of all hazards to which the em ployee is exposed. The standard further requires that the notification be within five working days after receipt of the employer's measurement results. Several industry comments requested a change In the five day requirement so as to allow ad ditional time for employers to comply. (Com. 47. 49. 54, 59). OSHA feels that, under ordinary circumstances, the five day limit fulfills the statutory require ment for promptness (section 8(cX3 yet allows employers sufficient time for the written notification. The standard further obligates the employer to provide the employee with a copy of the examining physi cian's written opinion. One Industry comment pointed out the large volume of letters per year which this notifica tion would entail (Com. 53). However, in view of the necessity for each em ployee to have an evaluation of his health. OSHA is of the view that fur nishing each employee with a copy of the physician's letter is not unreason ably burdensome. Written compliance programs are also required by the standard. These are discussed above under Methods of Compliance. The employer Is required to submit his compliance program, on . request, to OSHA and NIOSH. Addi- 1 tionally, he must make this program available at the worksite for examina tion by OSHA and NIOSH and by his employees or their authorized repre sentatives. One participant suggested that employers be required to give to each employee a notice of availability of the compliance program rather than merely making it available to the employee or his representative. OSHA feels that this would place an unneces sary burden upon the employer, and has not Incorporated the suggestion. Observation of monitoring: para- graph Cm). The final standard requires that the employer provide affected employees or their designated repre sentatives with an opportunity to ob serve the measuring of employee expo sures. This opportunity is specifically required by section 8(c)(3) of the Act. The standard also sets forth certain procedures which must be complied with in connection with the observa tion of the monitoring. These proce dures are designed to assure that the right to observe is meaningful and that the health and safety of the ob server Is protected during the observa tion. A few Industry participants request ed that the observation of monitoring provision be deleted from the standard (Com. 65). Union participants objected ( V MCD 000019255 PuHUshitl by Tilt: UUKfcl.VJ OF N A flOSAl. AFFAINS. INC.. W A SI f IN GTON. DC. 2003/