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R cCci VtD JUL 1 V 1980 OCCUPATIONAL SAFETY & HEALTH REPORTER A weekly review of occupational safety and health developments sj Volume 10, Number 6 THE BUREAU OF NATIONAL AFFAIRS. INC. uly 10, 1980 U.S, SUPREME COURT DECISION IN INDUSTRIAL UNION DEPARTMENT, AFL-CIO v. AMERICAN PETROLEUM INSTITUTE, MARSHALL v. API July 2, 1980 Part II Important Notice This opinion also will be printed in the next regular Decisions Supplement. Nos. 78-911 and 78-1030 Industrial Union Department, AFL-CIO, Petitioner, 78-911 t>. American Petroleum Institute et a]. Ray Marshall, Secretary of Labor, Petitioner, On Writ of Certiorari to the United States Court of Ap peals for the Fifth Circuit. 78-1036 ti. American Petroleum Institute et al. [July 2, 1980] SyilabuS The Occupational Safety ornl Health Art of 1970 (Act) delegates broad authority to (lie Secretary of Labor (Secretary! to ptnnej.ip.Ue standards to ensure e:ife and healthful working condition* for (lie Nation'* workers (tlie OceuiKitiuiwl Safety and Hcultli Administration (OSHA) being the agency responsible for carrying out tin- .mthori'y). Station 3 (S) of the Act defines an 'ocnijxttiou.d safety ;,tid health standard" ns a standard that if "reasonably neceneary mid appropriate to provide safe and healthful employment." Where toxic materials or harmful physical agents are concerned. a standard must r.l<n comply with C. (b)(5), which directs the Secretary to 1 s-i the standard which nio.-i adequately asfurta, to the extent feasible, on the ha.-ia of the be*' available evidence, that no employee will suffer material irri|>.iirrTi-*nt of health or functional capacity." When the toxic material or harmful phv-ical agent to be regulated i* a carcinogen, the Secretary ha.- taken the position that no s'.iie fvjitixrm; level can be delerminr-u and that U lb) (5) requires liitn to set an ciqHisiire limit al the lowest H-ibnolocirally feasible level that will not impair the viability of i:nhi>;ri*-s regulated. In this ease, after having determined that there is a r:m-l connection between benzene (a toxic sulwtunce used in muiuJu'iuriiie Mich product* a> motor fuels, solvents, detergent;. ami ].->ticid.-.) and leoki-inu (a cancer of the white blood evil.-), the Secret ary promulgated a standard reducing tlie permis sible CX|H>-urc limit oti nirlcvnic iv.iucntraikiio of benzene from IliC coti-rn.-us staiulard of 1(1 parts Un/coe ;*r million parts of air (10 ppm) lo 1 ppm. and prohibiting dermal contact with solution- contain ing benzene. On pre-enforcement review, the Cuurt of Appeals heid the standard invalid because it was based mi findings mn'tipported by tlie administ r.itive rvenrd. The iw cock lccd<d Unit DSH.\ hud ex ceeded its elniidarJ-scinng authority -rau.-e it had not been shown that the I ppm exposure inmt was " rises,,,..ibly iimssary or appropriate to provide safe and lienlthfnl rroplnviiien. '' a.- rixpurcxi b\ .`I (S), and that 6 (b)(5) did nut give OSHA the Uf-ridl.-d di-croi ion to adopt stand ards designed to create absolutely iLk-frov: workplaces regardless of Coat. Held: The judgment is affirmed. Mk. JusTtcu Stcvbsw, jotued by Mr. Chikt Justice Buuc.tR, Mr, Justice Stewart, and .Mu. Justice Powell, concluded that the stand ard in question is invalid. (a) Tlie Court of Ap|fal was correct i refusing to enforce the 1 ppm exposure limit on the ground that it was nol Mrp|iorteiI by appropriate findings. OSHA'a rationale for lowering the jvrmi.v-ihJc cx|Kurn limit from 10 ppm to 1 ppm win bn.xed, not on any finding that leukemia has ever been caused by exjio-iirc to 10 ['i>m of Ijoiizcik* and llial it will not be catiHxl by t.-N|>osnrt lo I ppm, but rather on a scrit- of assumptions indicating that sonic leukemia iiuplil re-ult from exposure to 10 ppm and that the imtulicr or ca-es might be reduced by lowering the exjiosurc level to 3 ppm. (b) I3y empowering the Secretary to promulgate standards tli.nl are "reasonably necessary or appropriate to provide safe or healthful em ployment and places of employment" as required by Ej 3 fS), the Act implies that, before promulgating any standard, the Secretary must make a finding that the workplaces in quest ion arc not safe. Hut "sife" is not the equivalent of ''risk-free." A workplace can hardly he considered "unsafe" unless it threatens the workers with a significant risk of harm. Therefore, before the Secretary can promulgate any permanent health or safety standard, he tmist mute a threshold finding that the place of employment Lx unsafe in the sense that significant risks are present and can be eliminated or lessened bv a cliangc in practice!. This require ment applies to ]>erm:iiicnt standards promulgated pursuant to 0 (b) (5), as well as to other types of jiermancnt standards, there Leir.g no reason why 3 (Si's definition of ti standard should not bo ilevtned incor porated by reference into ti (h) (5). Moreover, requiring the Secretary to make a threshold finding of significant risk is consistent with the scope of his regulatory jxjtver under 6 (b)(j) to promulgate standards for "toxic chemicals" and "hannjul physical agents." This interpretation Lx aupnnrted bv oflier provisions of the Act, Rich ns Sfifcl. whi-h requires the Secretary, in determining nrioritv for establishing stand ards. to cfee due regard to the urgerrv -*f the need fur mandatory jafetv ami health standards for particular '.L.Justrie or workplace*. and 6 whuh requires the SerrMarv when lie sitbxtnntiMlv alter* an existing consensus standard, to cxplair how tlie new rule will "better effeelii .te" ihe Act's nnrlnv.es. (r) The Act's legislative hi.-torv also -- iiiitorls the enni'lu.-ioti that Con* gres- was concerned. not with abe/iln'c safety, but with tin- elimination of tijrnifi'-ant harm (d) Where the Si-erelarv relied on n sjieeinl policy for rarriiicgens that imim-etl the biinfen mi indiisfrv of |ifo- i"r flic cXL-fciuv of ii ixde 1e'-el of exposure, llien-hv avoiding liL- threshold resixmsiliititi' of establishius the need for more stringent elundariJs. he exceedeJ his power. Mn. .IvsTrcE Stevknr. joined bv Mr. Chire Justice Burger and Mr. Justicp Ptew.aht. also enneiuded that: I. The burden vch* on OSHA to ehow, on the basis of s-nbsiaittjjt! evidetiec. that it i at }est more likeiv than not that long-ienu exrxnirc to 30 ppm of benzene prci*eots n signifinint n.-k of material health tnpairmenf. Here. OSHA did nol even attempt to carry stirii burden of proof. Imposing such a burden on OSHA will not strip it of its ability to regulate carcinogens, nor will it require it to wait for Recife to wait before taking ativ action. The requirement that n "*ignifi*ant" risk be Section fa. Published by THF BUREAU OF NATION ' 1. AFFAIRS. INC.. WASHINGTON. DC 20037 SAL 0000i^2iv 162 identified i tint n nt.-itheTTUittml >< r<i<: OSHA is not required to support jt> findjits that a .livnifiermt risk exists with unvfl-i'.r rmnrron-hic sri-ntific cortnintv: nnd t>< record in this ruse and D5HA1' own rnli'-e* on other i-scrini'af-w- intlirate ilmi there are s-iitirnWr cf wavs in which OSHA run make a riitiuiml iudeutctit aliont (hr relative sijrnifirmicr of (hr rii-kc n.-~o<"i,itr<l with expioure to a pariiculsr rarcinogeo. 2 OSHA ii il no* makr (ho required finding with reetiert fo (lit* derm-*) contact ban tii.it the Inn was ``rensonablv neres.-arv find appropriate" to remove a -ieiiific-mtt risk of liarm fnmi such contact. but rather acted on til- lia.-i- of thf alvt>ltlti`. nn-ri.-k |hiln-v that it applies to r:ir<-1rin?eii* under * iit* a.--ntuiiiiun* Hint ln*l o*dv is hcnii'ne in small d->ra a rarciuori-n )>ni iil'O (h it if rati Ut aliooritotl through the skin in sufficient asnomit- (o i>Tf%oitl n riir'Matffoliio risk. These iissirnmtio''* art* nnf a 1 irup'T -iib-tifiu.- fur the findings of significant risk of linrtn required by tho Art. I'p -IQ-52. Mk. Justicr Pn"ELL, nffrorin* that neither (hr airborne coru-entration standard nor the dcrm.d contact standard satisfied the Act's require ment-.. wou'd not hold that OSHA did not t-ven attempt to rnrrv its burden of proof on the thro-hohl <i>esi.-n whether cx|>csiire to benzene at 10 ppm pre-eiii-* a einrific-atd risk human health. He i-cii'-lnded that, i-'-iii ii"iiinin>r OSHA bad uni r;;.!i burden, the Act also requires OSHA to determine I hat the eronnrnn offc-ls of its standard bear a n-.ison.thle relation-hip In tin- i-Xfus-leil 'N-m-fits. A standard is neither reasonably nrcr-varv" lior "fi-io-ih'v,'' a- riqnir- <1 bv tin- Aft. if it mile for c-qe-idifur'-. whollv di-|rO|>orti<iiiaU- lo flu- i\|t.x-te<i health and srtfftv hctiefil- Here, allhmieii OSHA did fil'd that the `'substantial col>" of the benzene regulation- were justified, the rn-ord fwitains fieilhc-r adequate dnmtttitilalioti of this eoheln-ioti nor anv evidt-tiee that OSHA wi-iclnsl the relevant exm-idemt ions The ngrm-v eimnlv urtiioniieerl its finding flf eoit-jus(ifiaition without explaining the method by which it deierniunsl that the benefits justified the costa and their economic efl'i ls. Mit .TitsTter: KkmsoVIst wouhl invalidate, ns constituting an invalid deleealion tif legi-lativc nuthuriiy to the Secretary, the relevant ]>orfinn of 5 (i fh)f5) of the Aet :i it applitM In any lovtc substan.-e or harmful phisiial agent for which n safe h-vid is, according to the Secretary, unknown or odien'i'c "ittfetisible." In the ca-e of such sub-iaticcs. trie language of f> fbl fSV gives i hi- Pts-relarv absolutely no indication wlit-re on the ronlinnnm of relative safety he should set the standard. Kor is there anything in the lec-dative history, the stntutiuy context, or any other sourre traditionally examined bv this Court to provide speeifirity to the feasibility criterion in 50(b)(5), STtvrvs, J., armounred the judgment of the Court and delivered an opinion, in which lU'Ki;bn. C. J.. and Sncwoer, J.. joined, and in Parts I, 11. III - A 1 [ l-H, I tl-C. and III-H. of svliieh Pow-y.LL, .1.. joined JiUhCKR. C .1 , filed a concurring opinion. IVm ki.l. ,).. filed an ontnion cnnriirring in part and uiiieurrii.g in the judgment. Heh sqct>T, J.. fdrd an opinion con curring in the jielcin.nl. MxJisUalU J., filed u dissenting opinion, in svhicli liutNNxs, White, and Ui-ackju;n, JJ., joined. Mr. Justice Stevens announced tlie judgment of the Court end delivered an opinion in which The Chief Justice and Mit. Justice Stewart join and in Paris I, II, III-A-C and E of which Mu. Justice Po\vi.l joins. The Occupational Safety and Health Act of 1970, 29 U. S. C. 651 et seq. (the Act), was enacted for the purpose of ensur ing safe and healthful working conditions for every working man and woman in the Nation. This case concerns a standard promulgated by the Secretary of Labor to regulate occupational exposure to benzene, a substance which has been shown to cause cancer at high exposure levels. The principal question is whether such a showing is a sufficient basis for a t'andard that places the most stringent limitation on expo sure to benzene that is technologically and economically possible. The Act delegates broad authority to the Secretary to promulgate different kinds of standards. The basic definition of on "occupational safety and health standard" is found in 3 (8), which provides: "The term `occupational safety and health standard' means a standard which requires conditions, or the adop OCCUPATIONAL SAFETY & HEALTH REPORTER tion or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appro priate to provide safe or healthful employment and places of employment." 29 U. S. C. 652 (3). Where toxic materials or harmful physical agents are con cerned, a standard must also comply with j 6 (b)(5), which provides: "The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. Devel opment of standards under' this subsection shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addition to the attainment of the highest degree of health and safety protection 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," 29 U. S. C. 655 (b)(5).1 Wherever the toxic material to be regulated is a carcinogen, the Secretary has taken the position that no safe exposure level can be determined and tha' 6 (b)(5) requires him to set an exposure limit at the low-st technologically feasible level that will riot impair the viabdity of the industries reg ulated. In this case, after having determined that there is a causal connection between benzene and leukemia (a cancer of the white blood cells), the Secretary set an exposure limit on airborne concentrations of benzene of one part benzene per million parts of air (1 ppm), regulated dermal and eye con tact with solutions containing benzene, and imposed complex monitoring and medical testing requirements on employers whose workplaces contain 0.5 ppm or more of benzene. 29 CFR 1910.1028. 43 Fed. Reg. 5918 (Feb. 10, 1978), ns amended, 43 Fed. Reg. 27962 (June 27, 1978). On pre-enforcement review pursuant to 29 U. S. C. 655 (f), the United States Court of Appeals for the Fifth Circuit held the regulation invalid. 581 F. 2d 493 (1978). The court concluded that OSHA * had exceeded its standard-setting authority because it had not shown that the new benzene exposure limit was "reasonably necessary or appropriate to provide safe or healthful employment" as required by 3 1 The second and third sentences of this section, which impose feasibility limits on the Secretary and allow him to take into account the best avail able evidence in developing standards, may apply to all health and safety standards. This conclusion follows if the term "subjection" used in the second sentence relers to the entire subsection 655 (b) (which sets out procedures for the adoption of all types of health and .safetv standards), rather than simply to the toxic materials subsection. 655 (b)(5). "While Mr. Ji-sTict Marshall, post, at 7, mid respondents agree with this position, see Rrief for Re-pendents, ;it 39; see also Currie, "OSHA," 1976 Ain Bar Fonndutioii Research .1. IJ07, 1137, n. 151, the Government does not. see Brief foT Federal Parlies, a( 5S; see also Berger A- Rbkin, "Eco nomic and Technological Feasibility in Regulating Toxic Substances under the Occupational Safety and Health Act,'' 7 Ecol. L. Q. 285, 294 (197R) There i no need for us to decide this issue in this cose. 'The Occupational Safety and Health Administration (OSHA) is the administrative agenev within the Department of Labor that is responsible for promnlgntirg and enforcing ftandarcl? under the Act. In this opinion, ft refrr to the "Secreiary," "OSHA" slid the "Agency" interchangeably- 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. DC 20037 0? CURRENT REPORT (8),' and because 6 (b)(5) does "not give OSHA the unbri dled discretion to adopt standards designed to create absolutely risk-free workplaces regardless of costs." * Reading the two provisions together, the Fifth Cin-uit held that the Secretary was under a duty to determine whether the benefits expected from the new standard bore a reasonable relationship to the costs that it imposed. Id., at 5v3. The court noted that OSHA had made an estimate of the costa of compliance, but that the record lacked substantial evidence of any discernible benefits.4 We agree with the Fifth Circuit's holding that 3(8) requires the Secretary to find, es a threshold matter, that the toxic substance in question poses ft significant health risk in the workplace and that a new, lower standard is therefore "reasonably necessary or appropriate to provide safe or healthful employment and place.- of employment." Unless and until such a finding is mode, it is not necessary to address the further question whether the Court of Appeals correctly held that '.here must be a reasonable correlation between costs and benefits, or whether, as the Government argues, the Sec retary L- then required by C (b)(5) to promulgate a standard that goes as far as technologically and economically possible to eliminate the ri-sk. Because this is an unusually Important case of first impres sion, we have reviewed the record with special care. Tn this opinion, we (1) describe (lie benzene standard, (2) analyze the Agency's rationale for imposing a 1 ppm exposure limit, (3) discuss the controlling legal issues, and (4) comment briefiy on the dermal contact limitation. I Benzene is a familiar and important commodity. It is a colorless, aromatic liquid that evaporates rapidly under ordinary atmospheric conditions. Approximately 11 billion* 2 ''The Act imposes on OSHA the obligation to enact only standards that are reasonably necessary or appropriate to provide safe or healthful workplaces. If a standard docs not fit in this definition, it is not one that OSHA is authorized to enact." 5S1 F. 2d, at 502. "Although 29 U. S. C. A. 655 (b)(5) requires the goal of attaining the highest degree of health and safety protection for the employee, it does not give OSHA the unbridled discretion to adopt standards designed to create absolutely risk-free workplaces regardless of cost. To the con trary, that section requires standards to be feasible, and it contains a 2timber oi pragmatic limitations in the form of specific kinds of inforr=aticn OSHA roust consider in enacting standards dealing with toxic mater-ols. Tho.se include The best available evidence,' `research, demonjtraiior-s. experiments, and such other information os may be appropriate,' 'the latest available scientific data in the field,' and `experience gained under this and other health and safety laws,' Moreover, in standards dealing with toxic materials, just as with all other occupational safety and health standards, the conditions and other requirements imposed by the standard must be `reasonably necessary or appropriate to provide cafe or hftdthful employment slid piaces of employment.' 29 U. S. C. A. 652 (8)." 681 F. 2d, at 502. s "The lack of substantial evidence of discernable benefits is highlighted when one considers that OSHA is unable to point to nuy empirical evidence dojrn*ntirg n leukemia risk at 10 ppm even though that has been the permi^ible expo-ure limit since 1971. OSHA's assertion that benefits from reducing the jarrniwsilile exposure limit from 10 ppm to I ppm are likely to be appreciable, an assumption bssed only on inferences drawn from studies involving much higher expo.-urc levels rather than on studies in volving there levels or sound Rtnlidical projections from the high-level studies, does not satisfy (he reasonably necessary requirement limiting OSHA's action. Aquo Slide requires OSHA to estimate the extent of expected benefits in order to determine whether those benefits hear a reasonable relationship to the standard's demonstrably high costa." Id., at 50.3-504. 163 pounds of benzene were produced in the United States in 1970. Ninety-four percent of that total was produced by the petroleum and petrochemical industries, with the remainder produced by the steel industry as a byproduct of coking operations. Benzene is used in manufacturing a variety of products including motor fuels (which may contain as much as 2% benzene), solvents, detergents, pesticides, and other organic chemicals. 43 Fed. Reg., at 5918. The entire population of the United States is exposed to small quantities of benzene, ranging from a few parts per billion to 0.5 ppm, in the ambient air. Tr. 1030-1032. Over one million workers are subject to additional low-level ex posures as a consequence of their employment. The majority of these employees work in gasoline service stations, benzene production (petroleum refineries and coking operations), chemical processing, benzene transportation, rubber manu facturing and laboratory operation-.* Benzene is a toxic substance Although it could con ceivably cause harm to a person v.l.o swallowed or touched it, the principal risk of harm comes irom inhalation of benzene vapors. When these vapors are inhaled, the benzene diffuses through the lungs and is quickly absorbed into the blood. Exposure to high concentrations produces an almost immediate effect on the central nervous system. Inhalation of concen trations of 20,000 ppm can be fat** within minutes; exposures in the range of 250 to 500 ppm cm. cause vertigo, nausea, and other symptoms of mild poisonin'. 43 Fed. Ilcg., at 5021. Persistent exposures at levels nbo-c 25--40 ppm m.iy lead to blond deficiencies and diseases of the blood-forming organs, including aplastic anemia, which i> generally fatal. Industrial health experts have long been aware that ex posure to benzene may lead to various type3 of nonmalignant diseases. By 1948 the evidence connecting high levels of benzene to serious blood disorders had become so strong that the Commonwealth of Massachusetts imposed a 35 ppm lim itation on workplaces within its jurisdiction. In 1969 the American National Standards Institute adopted a national OSHA's figures indicate that 795,000 service station employees have aorne heightened exposure to benzene ns a result of their employment. See Economic Impact Statement, Vol. II, D-7 (May, 1977). These em ployees are specifically excluded from the regulation at issue in this case See i.'i/ra, at 17. OSHA stiiti'-? th:r another <i2'J,0"0 i-mptni era. who are covered by the regulation, work in the other industries described. 43 Fed Reg., at 5935. It is not clear from the record or its explanation of the permanent standard how OSHA arrived at the estimate of 629,(KX) exposed employees. OSHA's consultant, Arthur D. Little Company, estimated that there wore 191.000 exposed employees, 30,000 of whom wire exposed to l ppm or more of benzene. Economic Impact Slatemc-nt, Vol. I, 7-1. In its ex planation of the permanent standard OSHA stated that there were 1,440 exposed employees who worked in benzvnc plants, 9^,000 in oiher petro leum rtfineries, 24,000 in coke ovens, 4,000 in li-Ru oii plants, 2.7C0 iri the petrochemical industry, 52,345 who worker! in bulk terminals, 23,471 drivers who loaded benzene from those terminals, 74,000 in oil and gas production, 17.000 in pipeline work, 100 at tank cur facilities, 200 at tank truck facili ties, 4SO on barges, 11,400 in tire-manufacturing plants, mid 13,050 in other types of rubber production. 43 Fed. Keg., nt 5936-593S. Although OSHA gave no estimate for laboratory workers, the A. D. Little study indicated that there were 25,000 exposed workers in that industry. These figures add up to 347,216 exposed employees--approximately 252,000 k--.= than (he overall estimate of 629,000, It is possible that some or all of these employees work in the "other industries" briefly described in OSHA's explanation; th-se are primarily small firms that manufacture adhesives, paint and ink or that u.-e benzene solvents. 43 Fed. Res., si 5939 No estimate of the number of ex|sed employees in those industries or the aggregate cost of compliance by those industries is given either by OSHA or by A. D. Little in its consulting report. 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. D.C. 20037 SAL QCQC1c2?1 164 OCCUPATIONAL SAFETY & HEALTH REPORTER consensus standard of 10 ppm averaged over an eight-hour period with a ceiling concentration oT 2.5 ppm for 10-minute periods or a maximum peak concentration of 59 ppm. 43 Fed. Reg., at 5919. In 1971, after the Occupational Health and Safety Act was passed, the Secretary adopted this ronsensus standard as the federal standard, pursuant to 29 U. S. C. Co-5 fa).7 As early as 192S, some health experts theorized that there might also be a connection between benzene in the workplace and leukemia.' In the late 1960's and early 1970's n number of epidemiological studies were published indicating that workers exposed to high concentr.v ions of benzene were sub ject to a significantly increased T"- of leukemia.* In a 1974 report recommending a permanent standard for benzene, the National Institute of Occupational Health and Safety (NIOSH), OSHA's research arm,'" noted that these studies raised the "distinct possibility'7 that benzene caused leuke mia. But, in light of the fact, that all known cases ):?.d occurred at very high exposure levels, NIOSH declined to recommend a change in the 10 ppm standmd, which it con sidered sufficient to protect against nonmalignant dis-ases. NIOSH suggested that further studies were necessary to So: ion 6 i j) of the Act, 29 U. 5 O. 053 hi), pro-, ide* !hat "Wuhcui r- eird to chapter 5 of Title 5 or to the oilier :i.h*ectinj of this roction, the Secretary shall, as scon as practicable during the pencil beriming with the effective dale of this chapter mid coding two years after such date, by rale promulgate as .in occupational safety or heali.li standard any natimv.il consensus standard. and any established r'r.i?ra! itnmljr.i. unless he cltlcrmines that the promulgation of ruth a standard would not re.-u'.t in improved safety or he-Jih for -pecifically designated employees Jr. the event c; ccnff.rt among any smndaids. the Secretary 'hall pron-.ulgnte the standard which assures the greatest protection of the safety or health of the affected employees." In this case the Secretary complied with the directive to choose the most protective standard bo selecting Ihe ANSI standard of 10 ppm, rather than the -5 ppm standard adopted by the Ameriran Conference of Gov ernment Indm-triai lbgiemsts. -13 Fed. beg . at 5'Jllt. 'See Drlcrc ifc Bnrjrsinnno, "Lcoeejnie aicuo an fours de Eintoxicafion benzenique. Sur l'origine toxique de ccri.imes !eui'cmie< nigues ct leura relations aver les anemic? graves9 I. Med. [.yon 227 (192S). A transla tion of that document appears In the benzene administrative record. Vol U, 1 \ 2-idt ?iv ai-o llnnlci . 'Chi...... ExpO-uu- lo Benzine (Ben zol) II The Clinical Effects.'' 21 J Ind. J; Toxicol. 331 (1939), Vol II, Ex. 2-7-), which refers to 1 leucemi.n" as a ride effect of chronic exposure to benzene. * Dr. Muzaffrr Ak.-ov, a Turkish plwsir un who tesiified at the hearing on the proposed benzene standard, did a number of studies concerning the effects of benzene exposure on Turkish shoemakers. The workers in Dr Aksov's studies used solvents containing largo percentages of benzene and were constantly exposed to high concentrations of benzene vapors (between 150 and 650 ppm) under poorly ventilated and general^ unhvgier.ic conditions. See Ak.-ov, "Acute Leukemia Due to Chronic Exposure to Benzene." 52 Am .1, of Medicine 160 (1972), Vol f, E.x. 2-29; Aksov, "Benzene (Benzol): Its Toxicity and Effects on the Hematopoietic System" (Monograph) (I'WO), Vol. II. Ex 2-55; Aksov, "I eukemi c in Shoc-W'.irkers Exposed Chmry.caffv to Benzene," 44 Blocd S37 (1974), Vol. II, Ex. 2-53 (reporting mi 26 -hcit-wn.-kcrs who had contracted leuke mia from 1267 to 1973: this represented an incidence of 11 per 100,030 rather than the 6 rne per lOOOOO that would normally be expected). Dr Enrico Yigliari also reported an cxcc.-s number of leukemia cases Among Italian shoemakers expo.-ed l glues containing a Inch percentage of benzene and workers in r-depravi re plants who Ind been exposed over long periods <{ time to inks turd f<>1 vv-nt.s containing as much as 60% ben zene. fsc-p \ iglinni, "Benzene (: T.ruk-'miu." 1904 Xriv Eng J. of Medicim* K72-576, Vo! 1, Ex 2-27, Fond ,;c Viglinrii, "Chemici! LeuLemogenrsis in Man," 7 o-rr llaema' 21! (107-!), Vol. If, Ex. 2-50 ,''2r' L" ? C. 669 (a) (9) requires HEW to develop "criteria" dealing with toxic materials and harmful physical agents that describe "exposure levels that ire safe for various periods of employment." IJE'.V's obliga tions und-m this section have been delegate.) to NIOSH, 29 U S. C. 67). determine conclusively whether there was ft link between ben zene and leukemia and, if so, what exposure levels were -dangerous.*1 Between 1974 and 1976 additional studies were published which tended to confirm the view that benzene tan cause leukemia, at least when exposure levels are high." In an August 1976 revision of its earlier recommendation. NIOSH stated that these studies provided "conclusive'' proof of a causal connection between benzene and leukemia. Vol. I, Fx. 2-0. Although it acknowledged that none of the inter vening studies had provided the dose-response data it had found lacking two years ea-lier. id., at 9, NIOSH neverthe less recommended that the exposure limit be set as low a3 possible. As a result of this recommendation, OSHA con tracted with a consulting firm to do a study on the costs to industry of complying with the 10 ppm standard then in effect or. alternatively, with whatever standard would be the lowest feasible. Tr. 505-506. In October 1976 NIOSH sent another memorandum to OSHA, seeking acceleration of the rulemaking process and "strongly" recommending the issuance of an emergencv tem porary standard pursuant to 29 U. 3. C. > 655 fc) " for ben zene and two other chemicals believed to be carcinogens. 15 See Criteria for a Recommended Ennuard/fVr'jpaiioiial Exposure to Benzene 74-75, \ol. !, Ex. 2-3, In re;pon~e to a letter from the Director of the Office of Standards Diri.-ion, NIOSH ?ti!>."d that its 10 ppm stand ard was deigned to protect against leukemia, as well as other health risks. NIOSH noted, howeveT, that further research was necessary in order to establish adequate d<i;e-resuonse data for benzene and leukemia. Veil. XLl, Ex ?2.\. 32B. Ak-oy published another study in 1976 reporting on in additional e eht leukemia cases uncovered after 127-3 In that article, he also poled that a 1969 ban on the use of b-nzene as a solvent had led to a decline in the number of reported leukemia cases besrinnlnt; in 1974. Aksov, ` Typ"? of Leukemia in Chronic Benzene Poisoning," 55 Acta Haematolrgira 65 (I3<6), Vol. I, Ex. 2-30. Vigliani also noted a decline in leukemia Cases :n Italy after benzene was no longer used in glue* and inks, free VigJi.mi A: Forni, "Benzene and Leukemia." II Environmental Res 122 (1976), Vol. I, Ex. 2-15; Yjglbni, "Leukemia Associated with Benzene Exposure." 271 Annals N. Y. Acad, of Sciences 143 (19761, Vol. II, Ex. 2--49. In the latter study Vigliani noted that in the past 100% pure ben zene solvents had been used and worker? had been exposed on a prolonged basis to concentrations of 200-.500 ppm. with peaks of up to 1500 ppm. A number of epidemiological studies were also done among American rubber workers during this period. Dr. A. J. McMichaei'a studies indi cated a nine-fold increase in the risk of contracting leukemia among work ers who were heavily exposed in the 1940's and 1950`s to pure benzene used as a solvent. McMichae!, "Solvent Exposure and Leukemia Among Rubber Workers: An Epidemiologic Study," 17 J of Occup. Med. 234, 2.3ff (1975), Vo!. II, Ex. 2-37. See also Andjelkovic, Taulbee & Symons. "Mor tality Experience of a Cohort of Rubber Workers. 1G61-J973," IS .1. of Occup. Med. 387 (1976), Voi. II, Ex. 2-57 (also indicating an e\ce;5 mortality rate from leukemia among rubber workers). ^Section 655 (c) provider: "(1) The Secretary shall provide, without regard to the requirem-m*.' of chapter 5 of title 5, for nn eme-gency temporary standard to take imme diate effect upon publication in the Federal Register if he determines (A) that employees are exposed to grave danecr from exposure to ;u!>stances nr agents determined to be toxic or phvic.iiiv harmful nr (mm new hazards, and (B) that such emergency standard i? necessary >o pro tect employees from sue!) danger. "(2) Such standard shall be effective until superseded bv a standard promulg ped in accordance with the procedures prescribed in paragraph (.3) of this snb.a'etion. "(3) Upon publication of ~nch standard in the Federal Regi.-ter the Secretary shall commence a prciceedirg in accordance with 'ubsi-rtion (b) cf t hi- .-action, and the standard ns published shall a bo serve as a pro posed r'-le for the proceeding. The Secretary shall promulgate a standard under :hu paragraph no later than six month; aTter publication of the emergency standard as provided in paragraph (2) of this subjection. 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC., WASHINGTON. DC 20037 - Mt J CURRENT REPORT 166 NIOSH recommended that a 1 pprr< exposure limit be im posed for benzene.1* Vol. I, Ex. 2-6. Apparently because of the NIOSH recommendation, <'SHA p.sked its consultant to determine the cost of complyii'i' with a 1 ppm standard instead of with the "minimum fc-jible1' standard. Tr. 506507. It also issued voluntary guiedines for benzene, recom mending that exposure levels be limited to I ppm on an 8-hour time-weighted average basis wherever possible. Vol. II, Ex. 2-44. In the spring of 1976 NIOSH had selected two Pliofilm plants in St. Mary's and Akron, Ohio, for an epidemiological study of the link between leukemia and benzene exposure. In April, 1977 NIOSH forwarded an interim report to OSHA indicating at least a five-fold increase in the expected inci dence of leukemia for workers who had been exposer! to ben zene at the two plants from 1940 to 1949.!S The report sub mitted to CSHA erroneously suggested that exposures in the two plants had generally been between zero and 15 ppm dur ing the period in question.'* As a result of this new evidence and the continued prodding of NIOSH, Vol. I, Ex, 2-7, OSHA* li l* At the hearing on the permanent standard NIOSH representatives testified that they had selected 1 ppm initially in connection with the issuance of a propoj'-tl standard for vinyl chloride. In that proceeding they had discovered that I ppm was approximately the lowest level detect able through the use of relathely unsophisticated monitoring instruments. With respect to benzene, they also thought that 3 ppm was an appropriate standard because ar.y lower standard might require the elimination of the small amounts of benzene (in some places up to 0.3 ppm) that are norinaiiv present in the atmosphere. Tr 1112-1143. NIObH's recom mendation was jui4 based on nnv evaluation nf the feasibility, cither techtHilogic.il cu econom.c, of eliminating all exposure: abete 1 ppm. Tr. 1156. li Seven fntuJitie-- from leukemia were ih-rot ered out of 1 lie- 744 workers surveyed. However, Dr. Infante, who conducted the study, stated that his stnt'Stira! technique? had prrbably underestimated the number of leukemia rases that had actually occurred. Tr. 7)7. The normal expected incidence of leukemia in such a population would be 1.4. Vol. II, Ex. 2-51, si 6. "'The authors' statement with respect to exposure levels xvas based on 0 1946 report by the Ohio Industrial Commi-sioti indicating that, after some new ventilation equipment had been installed, exposures at the St. Marr's plant had been brought within "safe" lirni's. in most instances ranging firm zero to 10 to 15 ppm. Vo! II, Ex 2-51, at 3. A3 the authors Liter admitted, the level considered "safe" in 1946 was 100 ppm. Tr. S14-S15. Moreover, cnlv one of the -even winkers who died of leuke mia had begun working at bt. Mary's after 1946. Five of the other? bad worked at *be \krnn plant, which employed .'510 of the 748 workers sur- Tr. 2`.T7-2.ri5d A 1943 report by the same Commission indicated <-;pns.i * 'cvE; at -'-a \kroii plant of well over 10i) ppm, with excursions .a -nci' ..reas u*> 3000 ppm. Vol. XVII. II\- 54A fApp. A, Attach. F). cmrrev? :,cL?n :n the intervening years, as well a? testimony by St. Mary's cm-iov** ar the hearing on the proposed standard. Tr .3432-3437, indi- that both of the plants may have had relatively high exposures through the 1970's. Industry representatives argued at the hearing that this evidence indi cated that the exposure levels had been verv hieli, a; they had been in the other epuleminlncka! t;lie.1* conducted in the p.i. pee API pol-henring brief, Vol. XXXI, Ex. 217-33, at 23-37. NIOSH witnesses, however, sim ply stared that actual exposure levels for the years in question could not be determined; they did agree, however, that their study should not be taken as proof of a five-fold increase in leukemia risk at 10--15 ppm. Tr, S14-515 In its explanation of the permanent standard, Oc-IIA agreed Wi'h the NIOSH witrrsfe? that no dose-response relationship could be inferred from the study: Comment.-: nt ifie hearing demonstrated that ihefr- ivere area exposures dun;;: ihi. stud-.' pencil exctedmjr tli-'se level* fJQ-15 ppm], at times reaching values of hundreds of parts per million. Since no pe\si>m! rruntilorieg datn are acailahie. any conclusion regard.on the .v-tual indiv'diial time-we'glued average exposure is speculative Because of the lack of definitive exposure dam. 0$H.\ cannot d-ri.c any rcn.-lu-a-o* finking the excess leukemia risk i>it!i any specific exposure h-'-l." 43 Fed. Hep, at 5972. did issue en emergency standard*, effective May 21, 1977, reducing the benzene exposure limit from 10 ppm to 1 ppm, the ceiling for exposures of up to ;0 minutes from 25 ppm to 5 ppm, and eliminating the authority for peak concentra tions of 50 ppm. 42 Fed. Reg. 227.16 (May 3, 1977). In its explanation accompanying the ei icrgeucy standard, OSHA stated that benzene had-been shown to cause leukemia at exposures below 25 ppm and that, in light of itd consultant's report, it was feasible to reduce 11< exposure bruit to 1 ppm. 42 Fed. Reg., at 22517, 22521. On May 19, 1977, the Court of Appeals for the Fifth Cir cuit entered a temporary restraining order preventing the emergency standard from taking -fleet. Thereafter, OSTIA abandoned its efforts to make th emergency standard effec tive r.nd instead issued a. proposal for a permanent standard patterned almost entirely after the aborted emergency stand ard. 42 Fed. Reg. 27152 (May 27, 1977). In its published stalrmcnt giving notice of the proposed permanent standard, OSHA did not ask for comments as to whether or not benzene presented a significant health risk at exposures of 10 ppm or less. Rather, it asked for comments as to whether 1 ppm was the minimum feasible exposure limit.1' 42 Fed. Reg., at 27452. As OSHA's Deputy Director of Health Standards, Grover Wrenn, testified at the hear ing, this formulation of the issue to be considered by the Agency was consistent with OSHA's general policy with re spect to carcinogens.1' Whenever a carcinogen J3 involved, OSHA will presume that no safe level of exposure exists in the absence of clear proof establishing such a level and will accordingly set the exposure limit at the lowest level feasi ble.1* The proposed 1 ppm exposure limit in this case thu3 was established not on the bast- of a proven hazard at 10 ppm, but rather on the basis of "OSHA's best judgment at 57 OSHA also sought public comment to 'v'n***h<r certain industries should be exempt from compliance, whether the proposed compliance pro cedures and labeling techniques were adequate, what the environmental and economic consequences of the regulation would be, and whether it was feasible to replace benzene in solvents and other products ot winch it con stituted more than 1%. " It became cj^r at the hearing that OSHA had not promulgated the proposed standard in response fo any new crncern .-.hour (he nonm.iltgrnut effects of low-level benzene exposure. SeeTr. 126-127: "Is it accurate to say that the reason why the---why OSHA has pro posed to reduce the exposure limits in the standard below the current levels because of a perceived risk of leukemia, and rot because of any new evidence it has received that the current standards are inadequate to protect against acute or chronic benzene toxicity, other than leukemia? "MR. WRENN: I think I will simply refer the part of my statement you were referring to, in which it says, it is however benzene's kukemogenicitv which is of greatest concern to OSHA. That is certainly the renlrai issue within the 1CTS [emergency temporary standard) and 1 he proposed standard," " Mr. Wrenn testified that: . . The proposed standard requires that employee exposure to benzene in air be reduced to one part per million, with a five part per million ceiling allowable over any fifteen minute period during an eight hour work shift, and prohibits eye or prolonged skin contact with liquid benzene. "This airborne exposure limit is based on OSHA's established regulatory policy, that in the absence of a demonstrated safe level, or a no effect level for a carcinogen, it will be assumed that none exist, and that the agency will attempt to limit employee exposure to the lowest level feasible." Tr. 23-30. See also: "MR. WARREN: Mr. Wrenn, in promulgating the emergency tem porary, and proposed permanent, benzene standards, OSHA relies heavily, and I am quoting from your testimony now, on the regulatory policy that. 7-1080 Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. 0 C 20037 SM 00G012?3 166 OCCUPATIONAL SAFETY & HEALTH REPORTER the time of the proposal of the feasibility of compliance with the proposed standard by the affected industries." Tr. 30. Given OSHA's cancer policy, it wa3 in fact irrelevant whether there was any evidence at a'J of a leukemia risk at 10 ppm. The important point was that there was no evi dence that there was not some lisk, however small, at that level. The fact that OSHA did not ask for comments on whether there was a safe level c: exposure for benzene was indicative of its further view that a demonstration of such absolute safety simply could no; be made.5* Public hearings were held on the proposed standard, com mencing on July ID, 1977. The final standard was issued on February 10, 197S. 43 Fed. Keg. 5918.15 In its final form, the benzene standard is designed to protect workers from whatever hazards are associated with low-level benzene expo sures by requiring employers to monitor workplaces to deter mine the level of exposure, to provide medical examinations when the level rises above 0.5 ppm, and to institute whatever engineering or other controls are necessary to keep exposures at or below 1 ppm. In the standard as originally proposed by OSHA, the em ployer's duty to monitor, keep records and provide medical examinations arose whenever any benzene was present in a workplace covered by the ruled5 Because benzene isomuipre-* I there i* no 'flfe level for carrtriugens nl :iny--for .my exposed population, and the fart that leukemia, and a leukeniocen is a carcinogen, is that correct ? `MR WRKNN": I believe that I stated '.hat .-lightly differently in my oral summary of the statement than it is stated in the statement itself. I said that u> the absence of n known or demonstrated sale level or no effect- level, our policy is to assume that none exists, and to regulate acrordiritly." Tr. -5S--19. `MR. WRLNN: l would prefer to state it as I have on a couple of occasions already (his morning, aiul th it in the absence of a demon strated safe level of exposure, we \:Il assume that none exists for the pur pose of regulatory policy." Tr. 5f>. " In answer to the question of what demonstration would suffice to eftaLli-r. a "safe level," Mr. Wrenn stated: "I would like to draw a distinction, however, between what I have referred to as the demonstration that a safe level exists, and speculation or elaborate theories (hat one may make, and I chink (list the agency in its history ana very likely its futuie regulatory policy, would, in the face of evidence demonstrating that a carcinogenic hazard does exist or did exist, in this particular set of circumstances, would be very reluctant to accept R3 the basis for its regulatory decisions, a theoretical argument that a safe level may, in fact, <*xi>t for a pat ticular substance" Tr. 51-52. A NIOSH representative who testified later put it more succinctly, stating that . , if benzene causes leukemia and if leukemia is a cancer, then exposure is almost moot." Tr 1007. "An amendment to the standard was promulgated on June 27, 1978. 43 Fed Reg. 27962. See n. 22, i"/ra. 5J Apart fiotn its exclusion of gasoline -tornge and distribution facilities (an exclusion retained in the final rule, sec text, at n. 25, iii/m), the pro posed rule also excluded from coverage work operations in which liquid mixtures containing one percent or less benzene were used. After a veai this exclusion "as to be narrowed to operations where fl 1% benzene solutions were used. The rationale for the exclusion was that airborne exposures from such liquids would generally be within the 1 ppm limit. However, testimony at the hearing on the proposed rule indicated that there '.vis no `Tonsictent predictable relationship" between benzene con tent in : liquid and the resulting airborne exposure. Therefore, OSHA abandoned the idea of a percen'nge exclusion for liquid bcn2eiir in its fin.-1 -t.itid.ifn. 4 ' Fed. Iu-q . m 59-12 OSHA Liter reconsidered its position and, in tin amendment to the permanent standard, reinstated an exclusion for liquids, setting tin* level cl 0 5%, to be reduced to 0.1% after three years, -id Fed. Reg. 27952 (June 27. 197S). sent in small quantities, NIOSH nnd the President's Council on Wage and Price Stability recommended the lise of an `action level" to trigger monitr.'Mg and medical examina tion requirements. Tr. 1030-1033; Vol. XIV, Ex. 41-28 OSHA accepted this recommendation, providing under the final standard that, if initial monitoring discloses benzene con centrations below 0.5 ppm averaged over an eight-hour work day, no further action is required unless there is a change in the company's practices.55 If exposures are above the action lev*-!, but below tlie 1 pi'iitt i->:|Ki-urc` limit, employers are required to monitor exposure levels on r. quarterly basis and to provide semiannual medical examinations for their exposed employees. Neither the concept of an action level, ncr the specific level selected by O^HA, is challenged in this proceeding. V henever initial monitoring indicates that employees are subject to airborne concentration" of benzene above 1 ppm averaged over an eight-hour work''-iy, with a ceiling of 5 ppni for any 15-minute period, employers are required to modify their plants or institute work practice controls to reduce ex posures within permissible limits. Consistent with OSHA's general policy, the regulation does not allow respirators to lie used if engineering modifications are technologically feasible.'' Employers in this category are also required to perform monthly monitoring so long as their workplace? remain above 1 ppm, provide semiannual medical examinations to exposed workers, post signs in and restrict access to "regulated areas" where the permissible exposure limit is exceeded, and conduct employee training programs where necessary. The standard also places strict limits on exposure to liquid benzene. As originally framed, the standard totally prohib ited any skin or eye contact with any liquid containing any benzene. Ultimately, after the standard was challenged, OSHA modified this prohibition by excluding liquids contain ing less than 0.5*% benzene. After three years, that exclusion will be narrowed to liquids containing less than 0.2 % benzene. Tlie permanent standard is expressly inapplicable to the storage, transportation, distribution, sale or use of gasoline or other fuels subsequent to discharge from bulk terminals.51 * ** !lTlu: exemption from the monitoring and medical testing pernors of the standard for workplaces with benzene exposure levels below 0.5 ppm was not. predicated on any finding that regulation of such workplaces was ti.H feasible. OS 11.Vs coii.-uhaui, Arthur 1). Little Co., concluded that l ppm was a feasible exposuie limit even a.-yuiniing that there was no action level (or, to pul it another w.iy, assuming that the action lcv[ was zero). Ilather, it was, as NIOSH witnesses stated, a practical decision baaed on a determination that, where benzene exposures are below 0.5 ppm, they will be unlikely ever to rise above the permissible exposure level of 1 ppm. NIOSH was also concerned that, in the absence of an action level, employers who used sophisticated analytical equipment might be required to monitor and provide medical examinations simply because of the presence of benzene in the ambient air. Tr. 1030*1032, 1133-1134. ** Indeed, in its explanation of the standard OSHA states that an emp'ever is required to institute engineering controls (for example, in stalling new ventilation hoods) even if those controls are in-nfficicnt, by themselves, to achieve compliance and respirators must therefore be used as well. 4.3 Fed. Reg., at 5032. OSHA's preference for engineering modi fication? is based on its opinion that respirators are nn-lv used prnperiv (because fhev are uncomfortable, are often not properly fitted, etc.) and therefore cannot be considered adequate protective measures. !J It i? also inapplicable to work operations involving 0.5% liquid btrtzene (0.1% after three years), see n. 22. supra, and to the handling of benzene in sealed containers or systems, except insofar as employers are required to provide cautionary notices and appropriate employee training. 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC. WASHINGTON. DC 20037 S^L 0O031Q2? CURRENT REPORT This exception is particularly significant in light of the fact that over 795,000 gas station employees, who are exposed to an average of 102,700'g&Tlons of gasoline (containing up to 2% benzene) annually, are thus excluded from the protection of the standird.14 As presently formulated, the benzene standard ia an expen sive way of providing some additional protection for a rela tively small number of employees. According to OSHA's figure, the standard will require capital investments in engi neering controls of approximately S2G6 million, first-year operating costs (for monitoring, medical testing, employee training and respirators) of $187 million to $205 million and recurring annual costs of approximately SIM million.45 Fed. Reg., at 5934. The Figures outlined in OSHA's explanation of the cos** of compliance to various industries indicate thaton'v 35,000 employees would gain any benefit from the regulation in terms of a reduction in their exposure to benzene." Over two-thirds of these workers (24.450) are employed in the rub ber manufacturing industry. Compliance costs in that indus try are estimated to be rather ];>" v.illi no capital costs and initial operating expenses est.iiual.-b at only $34 million ($1390 per employee); recurring annual .o?f,s would also be rather low, totalling less than $1 million. Ry contrast, the segment of the petroleum refining industry that produces benzene would be required to incur S24 million in capital costs ami SCOO.OOO in first-year operating expenses to provide additional protec tion for 300 workers ($32,000 per employee), while the petro chemical industry would be requited to incur $20 0 million in capital costs and $1 million in initial operating expenses for the benefit of 552 employees ($30,675 per employee).2* 43 Fed. Reg., at- 5930-593$. Although OSHA did not quantify the benefits to each category of worker in terms of decreased exposure to benzene, it appears from the economic impact study done at OSHA's 71 Prior to the introduction of the action level concept, A. D. Little estimated that compliance costs for the eervire station industry might be a? high as S4 billion. Tr 305-500. Moreover, A. D. Little's Economic Impact Statement indicated that service station employees were generally exposed to veiy low level- of benvne Vo\. I, at 4-21 Suit, in i's exphwatino accompanying the permanent standard 0$H.\ did not rule out regulation of ibis industry entirely, stating tliat if '.''as in the pro<-e.-s of studying whether and to "hat extent, it should regulate exposures to gasoline in general. 43 Fed. Reg., at 59`3. i: OSHA's estimate of recurring annual costs was based on the assump tion that the exposure levels it had projected would be confirmed by initial monitoring and that, after the first year, engineering controls would be successful in bringing most exposures wjrhm the 1 ppm limit. Under these circumstances,- the need for monitoring, medical examinations and respira tors would, of course, be drastically redured. ,J Three hundred of these employees work in benzene plants, 5,000 in other petroleum refineries, 4,000 io light oil plants, 552 ; the petro chemical itidu.-trv, 150 m benzene transportation, 1,230 in laboratories, 11,10(1 in tire-manufacturing plants and l3,Q50 in other rubber-manu'nc'urine plants. OSH.\ also estimated that another 16,210 workers (5,000 - refineries, 1,104 in the petroi la-iuical indust ry, 7,300 in bulk ter 312 in b-uiz.enr transportation and 2,;>0O in laboratories) would I..- --in-vd to ''5 to 1 ppm of henzenc nr.d thus would receive a benefit n of more comprehensive medical examinations. +3 Fed. Reg., at Th- high cost jier employee in the latter two industry's is attributable to OSHA's policy of requiring engineering controls rather than allowing respirators to be u=ed to reduce exposures to.the permissible limit. The relatively low estimated cost per employee in the rubber industry is based on OSHA's assumption that other solvents and .adhesives can be substituted for those that contain benzene and that capital costs tv,)! therefore, not be required. 167 direction that those benefits may be relatively small. Thus, although the current exposure limit i3 10 ppm, the factual closures outlined in that study are often considerably lower. For example, for the period 1970-1975 the petro chemical industry reported that, out of a total of 496 em ployees exposed to benzene, only 53 were exposed to levels between 1 and 5 ppm and. only sewn (all at the same plant) were exposed to between 5 and lb' ppm. Economic Impact Study, Vol. I, table 4.2. See also tables 4.3-4.8 (indicating cample exposure levels in various industries). II The critical issue at this point in the litigation is whether the Court of Appeals was correct in refusing to enforce the 1 ppm exposure limit on the* ground that it was not supported by appropriate findings." Any discussion of the 1 ppm cx|losm; limit must, of course, begin with the Avi'iu-y'.' rationale for imposing that Hunt.'" Tie- written explanation of the standard Tills l $4 pages of the printed apnend'x. Much of it is devoted to n clUcussion of the voluminous evidence of the adverse effects of exposure to benzene at levels of concentration well above 10 ppm. This discussion demonstrates tliat there is ample justification for regulating occupational exposure to benzene and that the prior limit of 10 ppm, with a c.-ilirg of 25 ppm (or a peak of 50 ppm) was reasonable. It do;,s ' ot, however, provide direct support for the Agency's couc3usi<-u that the limit should be reduced from 10 ppm to 1 ppm. The evidence in the administrative record of adverse effects of benzene exposure at 10 ppm is sketchy at best. OSHA noted that there was "no dispute" that certain nonmalignant blood disorders, evidenced by a reduction in the level of red or white cells or platelets in the blood, could result from exposures of 25-40 ppm. It then stated that several studies had indicated that relatively slight changes in normal blood values could result from exposures below 25 ppm and per haps below 10 ppm. OSHA did not attempt to make any estimate based on these studies of how significant the risk of noimialignnnt disease would be at exposures of 10 ppm or less." Rather, it stated that because of the lack of data concerning the linkage between low-level exposures ami blood nbuonnalit'es. it was imnussiblc to construct a dose-response J0T'ne other issue before us is whether the Court of Appeals correctly refused to enforce the dermal contact ban. That issue i< discussed in Parr [V. uifrj, In the ervtirt below respondents also challenged the monitoring and medical teslirg requirements, arguing that rertnin industries should hnvtf ben totally exempt from (hem and that, as to other industries, the Agency had no*, demoni-trrued that ali the requirements were reasonably neee-siry to er='.ire worker health ami safely. They al.<o argued that OSHA's requirement that tire permissible exposure limit be met through engineering crntrrl? rattier than through rei-piudors was po*. reunnab'y' necessary under the Act. Reeatise it invalidat 'd the I ppm exposure limit, the Fifth Circuit had no occasion to deal with these issues, and they are not now before this Court. " As we lux e often In-kt, the validity of an agenev' determination mint be judged oil the ha-e- of the -i;>m-y's staled rea.-on* fur miking 'I at determiti.ilion. See Sf.'C v, C/icnery Corp.. ills 1`. 3. 30, *).> ("fAjn ad ministrative order cannot be uplu-itl itnUes the grounds upon wlii h the ageiiev acted in cM-rePiug ji. powers wire tlio-v upon wlij~h m art;, tr ran be sustained"); F!`C v. Trxaco. l"c., 417 U. S. 3S0, 3'J"; FTC v. Spcry X- ItutcUimcH Co., 405 U. S. 233, 249. JI As OSHA itself not^l, .some hlnml abeormalithw caus'd bv K-iui-ne cvporure may not. have any discernible health effects, while other? mav lead to ri'iinticnur lmpa n mint and e\en death. 43 Fed. Ileg. at 5*121. 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON, DC. 20037 SAL 168 curve at thi? time.'1 OSHA die) c-oiicIikIc. however, that the studies itevrioMstrAtt'd that the current 10 ppm exposure limit was inadequate to ensure that no single worker would suffer a nonmeiignant blood disorder as ft result of benzene exposure. Noting that it is "customary" tc sot a permissible exposure limit by applying a safety factor r' 10-JC0 to the lowest level at which adverse effects had be*u -t^served, tnc Agency stated that the evidence supported 11.cotvlu.-uou that the limit should be ~t at a point "substantially less than 10 ppm'' even if benzene's leukemic '-ffcct.' were not. considered. 43 Fed. R,?g., ac 5924-5925. OSHA did r.ot state, however, that the nor.vRaligniznt effects of benzene exposure justified a reduc tion in the permissible exposure limit to 1 ppm.1* CSH V also noted some studies indicating an increase in chromosomal aberrations in workers chronically exposed to concentrations of benzene "probably less than 25 ppm." :1 However, the Agency took no definitive position as to what these aberrations meant in terms of demonstrable health effects and stated that no quantitative dose-response relation ship had yet been established. Under these circumstances, chromosomal effects were categorized by OSHA as an "ad verse biological event of serious concern which may pose or reflect ?. potential health risk and p.s such, must be considered in the limber o'Tview of adverse health effects associated with benzene." 43 Fed. Reg., at. 5932-5034. With respect to leukemia, evidence of an increased risk fz. ., a risk greater than that borne by the general population) due to benzene exposures at or below 10 ppm was even sketchier. Once OSHA acknowledged that the NHOSH study it had relied upon in promulgating the emergen'':' standard did not support its earlier view that benzene had shown to cause leuke mia at concentrations below 25 ppm, see n. 12, supra, there was only one study that provided any evidence of such an increased risk. That study, conducted by the Dow Chemical Co., uncovered three leukemia deaths, versus 0.2 expected deaths, out of a population of 594 workers; it appeared that the three workers had never been exposed to more than 2 to 9 ppm of benzene. The authors of the study, however, con cluded that it could not be viewed as proof of a relationship between low-level benzene exposure and leukemia because all three workers had probably been occupationally exposed to a OCCUPATIONAL SAFETY & HEALTH REPORTER number of other potentially carcinogenic chemicals at other points in their careers and because no leukemia deaths had been uncovered among workers who had been exposed to much higher levels of benzene. In its explanation of the permanent standard, OSHA stated that the possibility that these three leukemias had been caused by benzene exposure could not be ruled out and chat the study, although not evidence of an increased risk of leukemia at 10 ppm, was therefore "consist ent with the findings of many studies that there is on excess hrikeinia ri-k among benzene expo-ed emplnvivs." 43 Fed. Reg., at 592S. The Agency made no finding that the Dow study, any other empirical evidence or any opinion testimony demonstrated that exposure to benzene at or below the 10 npm level had ever in fact caused leukemia. See 581 F. 2d, at 503. where the Court- of Appeals noted that OSHA was "unable to point to any empirical evidence documenting a leukemia risk at 10 ppm. . . /' In the end OSHA's rationale for lowering the permissible exposure limit to l ppm was based, not on any finding that leukemia ha; ever been caused by exposure to 10 ppm of ben zene and that it will not be caused by exposure to 1 ppm, but rather on a series of assumptions indicating that some leuke mias might result from exposure to 10 ppm and that the num ber of cases might be reduced by reducing the exposure level to 1 ppm. In reaching that result, the. Agency first unequivocally concluded that benzene is a human carcinogen.Jl* Second, it concluded that industry had fail--d to prove that there is a cafe threshold level of exposure lo benzene below which no excess leukemia cases would occur. In reaching this conclu sion OSHA rejected industry contentions that certain cpidemio'ogit-M studies indicating no excess risk of leukemia among wo; kcr? exposed al- levels below 10 ppm were sufficient to rstab1 sli (hat tile threshold level of safe exposure was at or above 10 ppm." It also rejected an industry witness' testimony that a du;e-respor.?e curve could be constructed on the basis of the reported epidemiological studies and that this curve indicated that reducing the permissible exposure limit from 10 to I ppin would prevent at most one leukemia and one other cancer d''ath every six years!:1* l V JJ "A dose-re.-pun-e curve .-Iium - the rei-.t :nu-lir|i bet \ - i <! tier. "I <-\en sure level* and r 1 :c n.-k of ratictr f<>r ,tm oilier *.!i.-i*n-c1 ;u-<vhti*d milt Iho-e e\po-ure level- funerallv, expi-surr in hi-dcT Pvi-I- <:<rri<~- with ,r a lusher ri-k. am! expn-ure in lower le\i'l- is aceottipum-d b'- n reiht'xd n*k " !vil F 24, a! nOi, i> 2 k OSHA'.- comments with rr.-pect to the insutfieieni'v of Hie rf.t-i were ndd'P.-reil primnnlv lo Hie lark of ibli it low expo-ure levels Oedft diil cor r!i.-ru*s whether il w.i-- ]>o-.ih|e < make a nmirli e-lmi.ile, hi'-d Oil Hie more coil!|iIrre r-j'i<|i'niiolitju-ii ami arnitia! Miide-* !- at hitdn-r expo-tire level-, of Hie sismfiriutee of Hu* fi.-hs -sttrihiit ihjo to thc.-e levels, nor did it di.-m.-s whether it iv.is |>o~ihle to i'\trnp<,l:iti: front ocb rjijlnates to derive a ri-k intimate fr*r low-lmel e\|'e.-un-s. "O^MA did not invoke tlic .mtormrii* rule nf reducin': t-vpn--'irc-s to Hie lowest limit feasible that it applies lo carver risks. Instead, the Secnd'ry re.v-oned that prudent health pntiev nvreiv required that the pemeifible exposure limit he set . , snfFirjentiy below the levels at which adverse CfTeets have been observed to a.-stir? .'d'-quale protection tor a*i exposed employee- " 4-1 Fed. Ib`z . nt T/bbV While D.-HA conclude! that appli cation of this ride would lend to an "\po-ure limit '`snb-tautjally !ea.i than 19 ppm." it del not -r.iro either what expn-ure level it eoriMderert to pre-ent a r'?mf,' aiii risk of harm or wlmt .-if.av fa. tor dmuld be applied to that !e\e! to e-i.ihk.-h a p'Tt;:t.-;th|e ex | insure limit. W'u'e ri'ina th.-.- studie?. OcH \ also noted that other studies of similarly exposed workers had nut indicated any iurrea.-ed level of chro mosome damage. `'''Tie- c-vui.-i'.-.- in rite record row hi-ivelv c-t;ibh-lu-* flint benzene is a hitman carcin-iyrn. The determination of benz-ne's leukomogertioirv is tie. rived from the evaluation of all the evidence in totality and i* not b-sed on any one particular study. OFHA ri-cognizes, as indicated above that in dividual reports vary coti.dder.iblv in quality, and that some investigations have significant methodological deficiencies. While recognizing toy strengths and weaknesses in individual studies, OSHA nevertheless concludes that the benzene record as a whole dearly establishes a causal relationship between lien-.-n- and leukemia." 13 Fed lies , at 55131. sr In Tfjvviin*' he-e Mudii-s, OSHA stated that: "Although the cpi- demiolcgical method can provide strong evidence of a causal relationship between exposure and disease in the ease of positive findings, it is by its very nature relatively crude and an insensitive measure." After notirg a number of spe.-ific ways in which such studies are often defective, the Agency stated chat it is . . OSHA's policy when evaluating negative sTudi--. to hold tlntii to :i higher -lull.bird of mi-i luidoinvii-a! ruriu v." 4-5 Fed. Ift-ir.. -it WI2 Xivuiniz ilie indu-.try Miidi.~ in thi.- listiu. OSHA iota-nulid that c-.u-b of them had sufficient nt.*1 luidolntucal defect: to nuk'- litem utitcliable indicalor.- nf the safety of low-level e.\po>uri-s to bviizwe-. ''OSHA rejected ibis te:timmiy it; part bt-cau-e- it in-li^ved the exposure data in the epidemiological studies to be inadequate *o formulate a doseresponse curve. It also indicated that even if the t*-i'itnony was accepted-- indeed as long as there was an'- increase in she ri-k r.i -oncer--the agency was-under an obligation to "select the le' ef of exp.vsure which most protective of exposed employees.'' 43 Fed. ltci;., .at 5P41. V 7-10-80 Published by ^HE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. DC. 20037 OCG Cl^ I. -_ CURRENT REPORT __________________________________ 169 Third, the Agency applied its standard policy with respect to r.'uviwjif'ns.1''' eondiulitift (hat. "i-thc alwncc of definitive proof of rt safe level, be ns-umed that any level above zero presents -some iufcrcased risk of cancer.* Aa the Goveminent points out irfjls brief, there are a number of scientists exposure limit that is the lowest feasible.41 Because of ben zene's importance to the economy, r.o one has ever suggested that it would be feasible to elinii..ate its use entirely, or to try to limit exposures to the strioil amounts that are omni present. Rather, the Agency selected I ppm as a workable end public health specialists who subscribe- to this view, exposure level. s?e n. 1-1. supra, -i\d then determined that theorizing that ft susceptible person may contract cancer from compliance with (hat level was t*-chnologically feasible ;nd the absorption of even one molecule of a carcinogen like ben that `cnc economic impact of . . . [compliance] will not be zene. Brief for Federal Parties, at 1S-19.41 such a3 to threaten the financial welfare of the affected firms Fourth, the Agency reiterated os view of the Act, stating or the genera] economy." 43 Fed. Beg., af. 5939. It there that it was required by 0 (b)(5; to set the standard either fore held that 1 ppm was the minimum feasible exposure level ot the level that lias been deinoi"-<mted to be safe or at the within the meaning of 6 (b)(5) of the Act. Finally, although the Agency did not refer in. its discussion lowest level feasible, whichever - higher. If no safe level of the pertinent legal authority to any duty to identify the is established, as in this case, the Secretary's interpretation anticipated benefits of the new standard, it did conclude that cf the statute automatically leads to the selection of an* * 3 * * *s*o*m* ieo benefits were likely to result from reducing the exposure, limit from 10 ppm to I ppm. This conclusion was based, again, not on evidence, but rather on the assumption that the risk of leukemia will decrease as exposure levels decrease. 31 in ill -- -III Mil .lit.- ru t M \l<-H <l.l .-lull - til;.I tin- Agency did not rd*- '`bliuoiy oji ,-otiu- draconian caiv-.mutcii 'niln-/ " in M-tting a pertni.-'-iblr exposure limit fur licma-rie Mr puml- !o the !.<number of tvilnMssrs tlie .tiwr herrrri .;mI tin- iiiliiniimm- rcon! il 'wiifwJi<1 :n evidcrvv th.it il relied instead on (In- < u-ik nl.ir f:ii-t* i'oi><-<.-inm|r ln,n,iir. With .ill due-re.-pift. we disagree wilh Mu itiIt-riii-o- tjiion of tin- Agency'*-- mlion.-ile for 3- l*--i^io>i- Af'-r hearing tlie evi dence. the Agviu-y relied cm ihe -,<mr poloy view ji h;ul stated at the tml-rl, .-ee pj*. 13-15, supro. ii.itm-!y rli-il. in lie- :iK-enic of <?<:,r e' i<fem-e to the contrary, it must he a-.-nmid iti.it no s.de h-vd r\i.*>.* for exposure to a carcinogen, The Agency :ds<> reached rIn* ctili;e)y pnxljrtablc con clusion that industry had not coined i>* i run(< die linpi"ihlo burden, -er ji. 11, iufrii. of jirm iiie that a *;i(c fuel of i-\|.o^-iiri- f(,r benzene. As the Agency made char !n1er in its generic earner policy. rce ti. 51, infra. il felt oomtM'lled to .Plan iinii;..;ry nilia-.-r. to go over the same ground iti each rcjtulntinn dealing v*itf> a can itcugcu, <J-- |<icc- its policy view. The gonerii- jxiliev. which liar, not yet gone into effect, was specif ically designed to eliminate till' riltpbialion o( itVmt in each ca-r hv Fnrc- cUi'iiuc industry from arguing that iliviv ri a -afe level for tin- par'i'-ul.ir carcinogen being regnlati-d. 42 Fed. R-g., a41 >4--.">4i.'ifc 3 stated above, fl.e {lo-itive sindic- on beiizcm* deimiristrnle the Although the Agency had found it impossible to construct a doso-respon^e curve that would predict with any accuracy the number of leukemias that could be expected, to result from exposures Rt 10 ppm, at 1 ppm, or at any intermediate level, it nevertheless "determined that the benefits of the proposed standard are likely to be appreciable."* 43 Fed. Reg., at 5941. In light of the Agency's disavowal of any ability to determine the numbers of employees likely p be adversely affected by exposures of 10 ppm, the Court of Appeals held this finding to be unsupported by the record. 581 F. 2d, at 503." K is noteworthy that at no po nt in its lengthy explanation did the Agency quote or oven cite 3 (8) of the Act. It made no finding that any of the provisions of the new standard were "reasonably necessary or appropriate to provide safe or health ful employment and places of employment." Nor did it allude to the possibility that any such finding might have been appropriate. causal relationship of benzene to the induction of leukemia. Although these studies, for the most part involve high exposure levels, it is OSH.A's view that once the carcinogenicity ol a substance has been established qualitatively, any exposure must be considered to be attended by risk when considering- any given population. OfiHA therefore believes that occupational exposure to benzene at low levels poses a carcinogenic risk io workers.'' 43 Fed. Rpg., at 5932. i The so-called "one hit" theory is hard nri laboratory studies indirat ing that ore molecule of a carcinogen may react in the test tube with one molecuie of DN'A to produce a mutation. The theory is that, if this occurred in the human body, the mutated molecule tumid replicate over a period of yrars and eventually develop into a cancerous tumor. See OSH.V3 Proposed Rule on the Identification. Classification ami Regulation of Toxic Suhxtaru-3 Posing a Potential Carcinogenic Risk, 42 Fed. Res'. 5414?, 54)63-54]67 (Oct. 4, 1U77). Industry vitiir-scs challenged this tbeorv, arguing tfiat the presence of several different drfen.-^' mei h,ini-Mf :n the human body make it unlikelv that a person would actually con tract cancer ss a result of absorbing one carcinogenic molecule. Thus, the molecule might be detoxified before reaching a critical rite, damage to a DNA molecule might be repaired, or a mutated DNA molecule might be destroyed by the body's immunological defenses before it could develop into a cancer. Tr. 2S36. In light of (he improbability of a person contracting cancer as a result of a single hit, a number of the scientists testifying on both sides of the issue nzreed that every individual probably does have a threshold expo sure limit below which he or she will not contract cancer. See, e. g, Tr. I179-I1SI. The problem, however, 15 that individual susreptibifity ap pears to vary greatly and there is ai pres-ut no way to calculate each and every person's thro.-huhi. Thus, even industry witnesses agreed that if the standard must ensure with absolute certainty that every single worker is protected from any risk of leukemia, only a zero exposure bmil would suffice. Tr. 2 192. 2S30. "There is no doubt that benzene is a mrcinogen and must, for the rnwc.iw isd safety of workers, be repainted as such. Given the in- crTT.r-rnrst? % threshold or establish a safe level, il is appropriate `ar. 05 AA presents that the permissible exposure to benzene be reduced : - '-ce lowest lev-l :ea.->ble.'' 43 Fed. Reg., at 5232. " l? an f-nri'er point in if? explanation. Q5HA slated: "There ,s eenernl .agreement that benzene exposure enure? leukemia as well as other fatal diseases of the bloodforming organs. In spite of the eerfnintv pf this conclusion, there does not exist an adequate scientific basis for establishing the quantitative dose response relationship between exposure to benzene and the induction of leukemia and other blood diseases. The uncertainty in both the actual magnitude of expected death? and in the theory of extrapolation from existing data to the OSHA expo sure levels places the estimation of benefits on 'the frontiers of scientific knowledge.' While the actual estimation of the number of cancers to be prevented is highly uncertain, the evidence indicate* that Ihe number raw be appreciable. There is general agreement that even in the absence of the ability to establish a 'thrediold1 of 'safe' level for benz-tie and other carcinogens, a dose response relationship U likely lo exist; that is, expo sure to higher dou-s earner- wi'lt it a higher riek of caiu-er, and (miver.-elv, exposure to lower leads is accompanied by a reduced risk, even liunjyb a p/ecijC rpi,>utJ;il e nrLitiiuiriiip r.innot (- established." 4-3 Fed. JR-j., at 5910, 11 The court did. however, huM that ihe Agency's other eoti-lu.-iutu-- th.it ihere is some ri?k uf leukemia at 10 ppm and that (lie ri~k would de-.reur by decreasing the cxportne limit to I ppm--were supported by snbiMntial evidence. 5$! F. 2d., at 503, 7.IO8O Published by THE BUREAU OF NATIONAL AFFAIRS. INC. WASHINGTON. DC. 20037 SAL CC.-0C1922T 170 III Our resolution of the issues in this case turns, to a. large extent, on the meaning of and the relationship between 5 3 (S). which defines a health and safety standard as a standard that is "reasonably necessary ami appropriate to provide safe or healthful employment," and 0(b)(5), which directs the Secretary in promulgating a health and safety standard for toxic materials to "set the standard which most adequately assures, to the extent feasible, on the basis of the best avail able evidence, that no employee will suffer material impair ment of health or functional capacity. . . In the Government's view, 3 (S)'s definition of the term "standard" has no legal significance or at best merely requires that a standard not be totally irrational. It takes the position that 6 (b)(5) is controlling and that it requires OSHA to promulgate a standard that either gives an absolute assurance of safety for each and every woih-- or that reduces exposures to the lowest level feasible. Tie Government interprets "feasible" as meaning technological; v achievable at a cost that would not impair the viability of :: c industries subject to the regulation. The respondent imiu-r--y representatives, on the other hand, argue that the C'ouri -if Appeals was correct in holding that the `'reasonably n> es*ary and appropriate" language of 3 f8). along with tin feasibility requirement of 6 (b)(5). requires the Agency to quantify both the costs and the benefit? of a proposed rule and to 'onclurle that they are roughly commensurate. In our view, it is not necessnrv to decide whether either the Government or industry is entirely correct. For we think it is clear that $3(8) does apply to ail permanent standards promulgate1:] under the Act and that it requires the Secre tary, before issuing any standard, to determine that it is reasonably necessnrv and appropriate to remedy a significant risk of material health impairment. Only aftci the Secretary has made the threshold determination that such a risk exists with respect to a to.xie sulist.mce. would it be necessary to de ride whether $ 6 (b)(5) requires him to select the most pro tective standard he can consistent with economic and tech nological feasibility, or whether, as respondents argue, the benefits of the regulation must be emnmensur.ite with the costs of its implementation. Because the Secretary did not make the required threshold finding in this case, we have no occasion to determine whether costs must ho weighed against benefits in an appropriate case. A Under the Government's view. > 3 (SI, if it ha. any sub stantive content at aU,`merely requires OSHA to issue stand- OCCUPATIONAL SAFETY & HEALTH REPORTER that are reasonably calculated to produce a safer or more healthy work environment. Tr. of Oral Arg. P5, 20. Apart from tins minimal requirement of;ationality, the Government erguos that $ 3 (S) imposes no limits on the Agency's power, and thus would not prevent it from requiring employers to do whatever would be "reasonably necessary" to eliminate all risks of any harm from their workplaces.45 With respect to toxic substances and harmful physical agents, the Government takes an even more extreme positic:*.. Relying cm 5 6 (b) (5)'a direction to set a standard "which most adequately assure? .. . that no employee will suffer mafe-ial impairment of health or functional capacity," the Gove, ument contends that the Secretary is required to impose standards that cither guarantee workplaces that are free from any risk of material health impairment, however small, or that come as riose os possible to doing so without ruining entire industries. If the purpose of the statute were to eliminate completely and with absolute certainty any risk of serious harm, we would agree that it would be proper for the Secretary to interpret $5 3 CS) and 6 (b)(5) in this fashion. But we think it is clear that the statute v.as not designed to require employers to provide absolutely risk-free workplaces whenever it is tech nologically feasible to do so. so long as the oast is not great enough to destroy an entire industry. Rather, both the lan guage and structure of the Act. .as well as ita legislative history, indicate that it was intended to require the elimination, aa far n> fenjihl--. of 'iguificaiit risk? of harm. B By empowering the Secretary to promulgate standards that are "reasonably necessary or appropriate to provide safe or healthful employment and plm-t-s of employment." the Act implies that, before promulgating any standard, the Secretary nm-t m.-ike a finding that the workplaces in question are not safe. Bui "safe" i- n*>t the equivalent of "risk-free." There are many activities 111nI w> engage in every 'lav---such a** tlrhing a car or even breathing city air--that entail some risk of aeeid-ht or tnalerial health impairment; nevertheless few people n.iul'i roiisjih-r these activities ''unsafe." Similarly, a worki'k-cr- far. hardlv L,-. considered "unsafe" unless it threat en* the workers with a sigiiife-.-iMt risk 'if harm. Therefore before he can promulgate nun permanent health or safety standard, the Secretary is required to make a. thresh old finding that a place of employment is unsafe--in the sense that significant risks arc piesev*. and can be eliminated or lessened by a change in practice- This requirement applies to permanent standards pn.mulcted pursuant to 5 6(b)(5), " Ve cannot nrirpf pie argument tint .3 (dl i.-- tnt iliv mc.-minglo*.* The Act intlwruo-s Pie Secretary to pn/inuljralc three d.fh-reiit kinds of st,niilard.'*--notional rnncnsu-- standard*. permanent stat-dard* and tem porary emercenry Uumbni-' Tie- ordv -uIm.-u-iivi* criteria given /or two of lhee--n it lonnl coim-n-nr r-la ud:i rd-i .n.d |,i-rm:in.-iil U am la r. Is for mi f..-ly hru.nnh not revered hv fi --are -t h>ith in $3. Wlijli- jr is true that 3 is i-ii til Ji-ti "de/initioii-.," tli it fact i|ms not diain e.u-ll d'-finili'-rt of suh-iiari'ne content. For other-.* i.-e, thi-re would 1m* no purpose in de fining the critical terms of flu- statute Moreover, if the definitions were ignored, there would be n statutory crP*ri. ut all to guide tin* Secretary in promulgating either national consensu- standard* or permanent stand ard* other than tho.-c dealing with toxin materials and harmful physical ngrnt*. We mav not expect Conge's* to display perfect mfimanship, but it is nure-dene to assume that it intended to give no direction whatso ever to the Secretary in (iromolg ifinir rno-t of his standards. The si nirt-.ue of ihc separate subsection describing emergency temporary standards, 2D U. S. C. fin5 (c>. quoted supra, n. 13, supports this concki- sion. It authorizes the S.-cr.'tarv to byjvass thr normal procedures for seltinir permanent Ff.mdnrds if hr makes two findings: (A) that oinpluvcrs are cxpnsoj to "grave danger'* from exposure to toxir substance* and (B) that an emergency standard is 'lurevnry'' to protest the emplove from rim d.Mar. r, Three finding* are to lie compared wiih those that are imylitulv required by the dilioiliei: of the permanent standard--(A) that there be .a signiiic.ini--as oj-.iio.--cd to a `grave*'--risk, and (R) that addi tional regulation is "roa-aiinhly ner.-^-ary or appropriate''--as oppo.'-d to "nfrc-'-arv '* Ii would h- .iiiotiialou.- fur C<mgr** to require specific find- ires lor temperirv slaiulard* but lo give the Secretary a carte Iila'icke for [H-munrni *!and irds. , "The Government docs not conccitc lh.it the fca-ihi|it* requirement in the second xntence of i>(M(f>) .ipj.lies to health and Nlfetv standards other limn toxic .-'.ib-l.:n<-es si.intard*. Fee n. 1, supra. However, even if it did, *h# Go. enim- ru** mt:-rpr*-f.jfion of the term 'TeasiM''/* when K'uj.I.-l mi>It it- \i;iv m 5.1 f'i. would -iill allov (In* Agoiwv hi require' the elimination of even ifisiL"iifv;anr risks at 5re.1t cost, so Ion" as an entire' industry's viability would not be j-ojianlised. 7-1080 Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. DC. 20037 SAL aCQ01922 .li.,jj-: jv-i--... tj.'.,.. a. *3 3* fcl,'! C tr CURRENT REPORT a> well as to other types of ;.erman':t?- standards. For (here is no reason 3 *8definition of a standard should not be deem^^ut^orincted by reference into 5 Q (h)(M. Tlie ?t2udar<fe?pwitmdgatt'd pursuant to 5 6(h)(5) are just nne species of'tlW^enus of standards governed! by the basic requirement. That section repeatedly uses the term '`standard" without suggo.vthig any exception from, or quali fication of, the cr-ncval definition; on the contrary, it- directs the Secretary to select "Ifie p*:tiiH:icd''--that is to say, one of various possible alternatives that satisfy the basic definition in 5 3 ($)--that is most protective/7 Moreover, requiring the Secretary to make & threshold finding of significant risk is consistent with the scope of the r-gubitory power granted to him by 5 6 (b)(5), which empowers the PerrHury to promul gate standards, not for chemical- ami physical agents gen erally, but for "toxic chfcmicnW and ''harmful physical agents." ** This interpretation of 55 3 (8) ar.d o (h)(fi) is supported by the other provisions of the Act. Thus, for example, 0 (g) provides in part that "In determining the priority for establishing standards under this section, the Secretary shall give due re gard to the urgency of the. need for mandatory safety end health standards for particular industries, trades, crafts, occupations, bu sir esses, workplaces or work environments." The Government has exprc'-dy joknmvieckt-d that this section requires the Secretary to undertake xyme co.'Mwmfit analysis before he promulgate? any standard, reouinn? the elimination of the most serious hawrtk U Swh n analysis must precede the promulgation <d any ctardar}. it Sdt'lfiS manifest umt. Congress intended ata-tac? mimmtms, that the Secretary find a .I.S*, ,,of hnn,, a ,,vohaVlWv of S:^uficant benefits before esed.b-mr* a ne,v w`aKcJaf(J ^Socdon 6(M(51 parallel.? JO fa) m nr? -.)nT, ft quire* the Secretary. ),? h.r-rd wish h. h<-H-n Pm n.itinnnl Cnn- In <h">l*r lilt'UW 'T<'/r,-m-- 1. ,,v n,t,,.-7_ s,,;il|.( JTJUJIfj,/'s nat ^`5f iht f,!W w ;>rotpc!k standard md ** r ** *. :Zm,n 171 Section 6 (b)(S) lends addition.*! support to this Analysis. That subjection requires that, v.-her. the Secretary substantially alters an existing consensus standard, he must explain how the new rule will "better elTocttiate" t-lm purposes of the Act/* If this requirement was intended to be wore than a meaning less formality, it must be read to impose upon the Secretary the duty to fir.d that an-existing mdicrta) ron.sensus standard >. not adequate to proh-et workers from a continuing and significant risk of harm. Thus, in this case, the Secretary was required to find that exposures at the current permissible expo-ore level of 10 ppm present a significant risk of harm in the workplace. In the absence of a clear mandate in the Act. it is unreason able to assume that Congress intended to give the Secretary the unprecedented power over American industry that would result Icom the Government's view of > 3 (8) and 6 (b)(5), coupled with OSH.-Vs cancer policy. Expert testimony that asubstance is probably a human carcinogen--either because it lias caused cancer in animals or because individuals have con tracted cancer following extremely high exposure?--would jus tify the conclusion that the substance poses some risk of serious harm no matter how mimite the exjjoanre and no mat ter how many expert? testified that they regarded the risk as insignificant-. That conclusion would in turn justify pervasive reeulat-ion limited nnlv by the constraint of feasibility. In light of the fact that there are literally thousands of substances used in the workplace that have been identified as carcinogens or suspect carcinogens, the Government's theory would give OSHA power to impose enormous costs that might produce httK if any. discernible Umcfit.'1 If (he Government were correct in arguing that neither- 3v8) nor 5 0(h)(5) requires that the risk from a toxic SubstfdlN' ^ CjMbtified ?ufii>-jpntiy to enable- the Secretary to charaderue it 1(3 Rgnfe jd an understandable way, i-naradfwe it a? , ., u..ute wW maVr swt a V^ww < .. nf * w is- tW lap t|,w d.t h'* mwonsrilutlO!i:i! Ill ifep/y Bwf, at 13. Th. Covm.m,<,( *nrite? {||P 0! prhrim wk !k< $rtiwJ< m 10 j,wiW;i( review, Tr, of 01 J. im ** Zimbh` on th t - -- ijj.h . " **sul( -f, n-C'lX' t,f ,i , 1!l dtgrtts >r. k. , Al.f.iC..."r n--,."'v.s-r/',v.S,,.,.. r'-st-. J,,;, .,b;, ................................... ( n " nh - K ' '-J!;" d,,r fiV 5icf, 3f( . V' m,( - '""bid H,.,, $h rbf r m .,- Ilr'' "'< eerifnt. tr^v m"^ ^ c^r^i* Pnn*.>l-r .1. In . >*> ,,> end r ^ ,nr`'noro freJfv.1' < ^7'T'sr* TM :?*' >*??% >*,!? ^:,i:fcnrT :u ^`cJrn,n fr0l7J snro? '**, m ,* -V'fic yin.v "'d, <>r ^4n,;ia,rc . " Minina,,-. : fw r"l<T,np. y ff,- ,0t* ttui "n* "*'t>fo,vrf ,,[llp[.n-,.r/ K'r,u,`l u x-l Or by *014 (0 '"`'"nr* - Hi;wC',"* .VfO -"'^i 10 >* 'wicl,,,il. / l\h N'o 7? .- ......... - out C(|rrr-nt /'<-i f-. - oif Tn 172 OCCUPATIONAL SAFETY & HEALTH REPORTER CourtMasoning in S'-hri-ittrr Poultry Cyrp. v. Cmted States. 20.`i C. S. .-j.00. ami I'nxuiiia Rifimuy Co. v. Hyatt, 203 V. S. 3SS. A 4-on-irm'tioM.qf.tlu* statute that avoids tliia kiiui of opco-cmu-'l grant sluuiM cwiuiuly be favored. C Too lt'silativf lii<r<uy nl.-o support? the conclusion that Conere-.? m:i< eoiir'c'rned. imt with absolute safety, but with tl < I'j'iniuation of siynifii-nnt harm. The examples <>f jmlitstrial .hazard? referr*,d to in the eoiuiiiitVc hearings and debates all involveil situations in which the risk was unquestionably significant. Fur example, the Senate Committee on Labor and Public Welfare noted that h\nsinosis. a disabling lung disease caused by breathing enfou dust, affected a? many ns oO'/i of t!ie workers in huding or i p"inii;g room- in eaim* Ameri can cotton mills and that as uum> as 100,000 active or retired workers were thru suffering firm, the disease.. L also noted that statistics indicated that 20,000 out of 50,COO workers who had performed insulation work were likfdy to die of asbestosis, lung cancer or mesothelyioma as a result of breathing asbestos fibers. Another example give i of an occupational health hazard that would be controlled by the Act was betanaphthylamin.e, a "chemical so toxic that any exposure at all is likely to cause the develop!)itqi t oi hladder cancer over a period of years.'' . Rep. No. P1-12S2, at 3--1 (91-:t Cong., 2d Ses?.), Legislative History. Occupational Health and Safety Act of 1070, pp. 143-- 144 (1971) (Comm. Print). Moreover, Congress specifically amended 5 G (b) (5) to make it perfectly clear that it does not require the Secretary to promulgate standards that would assure an absolutely risk-free workplace. Section 6(b)(5) of the initial Committee bill provided that "The Secretary in promulgating standards under this sub section, shall set the standard which most adequately and feasibly assures, on the basis of the best available evi dence, that no employee will suffer any impairment of health or functional capacity, or diminished life expect ancy even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life." (Emphasis supplied.) S. 2193, 91st Cong., 2d Sess., at 40; Legis. Hist., at 243. On the doc of the Senate, Senator Dominick questioned the wisdom of this provision, stating "How in the world are we ever going to live up to that? What are we going to do about a place in Florida where mosquitoes are getting at the employee--perish the thought that there may be mosquitoes in Florida? But there are black flies in Minnesota and Wisconsin. Are we going to say that if employees get bitten by those for the rest of their lives they will not have been done any harm at all? Probably they will not be, but do we know?" Legis. Hist., at 345. He then offered an amendment deleting the entire subsection." After discussions with the sponsor? of the Committee bill, sl In eriti'hir the Committee hill, Senator Dominick alio made the allowing observations: "It is unrealistic to attempt, as this section apparently does, to establish & utopia free from any tmarcL. Absolute safety is an impossibility and it will only create confusion in the .administration of this act for the Con gress to set clearly unattainable goab." I.egis. Hist , ut 480. Senator Dominick revised bis amendment. Instead of delet ing the first sentence of 5 6 (b)(5) entirely, h:s new amend ment limited the application of that subsection to toxic materials and harmful physical agents and changed "any'' impairment of health to "material" impairment." In dis cussing this change. Senator Dominick noted that the Com mittee's bill read as if a standard had to "assure that, no matter what anybody was doing, Che standard would protect him for the rest of his life again. t any foreseeable hazard." Such an "unrealistic standard," he stated, had not been in tended by the sponsors of the bill. Rather, he explained that the intention of the bill, as implemented by the amendment, was to require the Secretary . . to use his best efforts to promulgate the best avail able standards, and in so doing, ... he should take into account that, anyone working in toxic agents and physical agents which might be harmful may be subjected to such conditions for the rest of his working life, so that we can get at something which might not be toxic now, if he works in it a short time, but if he works in it the rest of his life might be very dangerous; and we want to make sure that such things are taken into consideration in establishing standards." Legis. Hist., at 502-503.J< Senator Williams, one of the sponsors of the Committee bilb agreed with the interpretation, and the amendment was adopted. In its reply brief the Governmew argues that the Dominick amendment simply means that th- Secretary is not required* "But I ask, Mr. President, just thinking .ibeut that language let us take a fellow who is a streetcar conductor or a bus conductor at the present time. How in the world, in the process of the automobile accidents that we have all during a working dny of any one driving a bus or trolley car, or whatever it may be, mn we ,-et standard* that will make sure he will not have any risk to his life for the rest of his life'' It is totally impossible for this to be put in a bill; atul yet it i* in tin- committee bill." Legis. Iliat., at 42.?. As xn opjioi'ent of the h-gisl.iiion, F-milor Dominick may have exag gerated the significance uf the problem since the language in H(P) already iv.as sufficient to prevent the Secretary from trying "to establish a utopia Irt-e from any hazards,'' Nevertheless, the fact that Congress amended the bill to allay Senator Dominick's concern denumstrates that it diil not intend the -luiute to achieve "clearly .iiiiittaiiiable eonk." 11 Senator Domnin k bad also been roncerned that the placement of the word 'feasible" coaM be read to require the Secretary to `ban all occu pations in which there remains some risk of injury, impaired health, or life c\|ea t;iiu>since the way to nni*t "adequately" and "feasibly1' assure nteqlutc protection might well be to prohibit the occu|wition entirely. Lcgi". Hist., at 3Gf*-307. In his final amendment, lie attempted to cure this problem by relocating the feasibility requirement, changing "the stand ard which mo.-t adequately and fea.-iblv a.-vuirea" to "the standard which most adequately tissurt-q to I lie extent feasible." il Mu. Justice Marshall argues that Congress couM not have thought '! (81 bad any Mib-tantive meaning inasmuch as 6 (b) (51, as originally drafted, appliisl to all -Inndards and not simply to standards for tunic material- and harmful physical substances. However, as this legislative hi.-torv indicat's, it a]i|n-ars that the omission of the words "toxic sub stance-'' and "lianiiful physical agents" from, the original draft of 6 (b) (5) was entirely inadvertent. A- Senator Dominick noted, the Committee had abiai -* intended that sub.-dtion to apply only to that limited category of -iib-iames. The reason that Congress drafted a apt-cul section for the-e substance* was not, a? Mu. JcaTtCt Marshall suggests, because it thought tli it there was a fus'd for .-jreend protection in these areas. !hith>w, it was because Congrv;- tv ognixed that there were special problems in regulating health ri.-ks a* opposed to safety risk*. In the latter ruse, the risk* urc' generally iimncrlnte mid obvious, while ill the former, the ri.-ks uwy not he evident until a worker has been cxpo.-ed for long periods of time to jur.icul ir sub-taii'<ss. It was to ensure that the Secretary took account of these long-term risk- that Congress enacted 0 (b)(5). 7-1080 Published by THE BUREAU OF NATIONAL AFFAIRS. INC. WASHINGTON. OC 20037 SAL 0CCCi 2 CURRENT REPORT 173 to eliminate threats of insignificant harm; it argues that 6 (b)(5) still requirea^the Secretary to set standards that ensure that not even on&wnployee will be subject to any risk of serious harm--no mfUer how small that risk may be.3'* * 6 This interpretation is atjadds with Congress' express recogni tion of the futility of trying to make all workplaces totally T??k-free. Moreover, not even OSHA follows this interpreta tion of 6 (b)(5) to its logical conclusion. Thus, if 05HA is correct that the only no-risk level for leukemia due to benzene exposure is zero and if its interpretation of 6 (b) (5) is correct, OSHA should have set the exposure limit as close to :.ero as feasible. But OSHA did not go about its task in that way. Rather, it began with a 1 ppm level, selected at least in part to ensure that employers would not be required to eliminate benzene concentrations that were little greater than the so-called "background" exposures experienced by the population at large. See n. 14 supra. Then, despite sugges tions by some labor unions that it was feasible for at least some industries to reduce exposures to veil below 1 ppm,:i OSHA decided to apply the same limit to ail, largely a? a matter of administrative convenience!. 43 Fed. Reg., at 5947. OSHA also deviated from its ov n interpretation of 6 (b) (5) in adopting an action level of ".5 ppm below which moni toring and medical examinations ..re not required. In light of OSHA's cancer policy, it must have assumed that some employees would be at risk beem se of exposures below 0.5 ppm. The'e employees would thus presumably benefit from medical examinations, which might uncover any benzene-re lated problems. OSHA's consultant advised the Agency that it was technologically and economically feasible to require that such examinations be provided. Nevertheless, OSHA adopted an action level, largely because the insignificant ben efits of giving such examinations and performing the necessary monitoring did not justify the substantial eost." OSHA'- concessions to practicality in beginning with a 1 pnm exposure limit and using an action level concept im plicitly adopt an interpretation of the statute as not requiring regulation of insignificant risks." It is entirely consistent with a-Reply Brief, :il 2-1-20. While it is True that turn-.' of Sender Dominiik's comments were concerned with the relative urvmixKtnnce of minor injuries (sc: his ''fly" cx.iiny'e quoted at p. 30. supra). it is Hear that hp was also concerned with the remote possibility of major injuries, *ee n. 52. supra. a'Otie union -tiaaesled a 0.5 ppm ponni.-sible expo.-ure limit Tor oil refineries and a. 1 ppm ceiling (rather than a time-weighted average) exposure for all other industries, with no use of an action level, Tr. 1250, 1257. Another wanted a 1 ppm ceiling Limit for nil industries, Tr. 3375. 3!_"A ned for an action level is also miiji-Ii'i! hv tin- record p'-idc;ii-r> that some minimal exposure to benzene occurs naturally from animal and plant matter (TR. 740-750: 7.i0-760>, Naturally occurring benzene con centrations, it- appears, may range from 0 02 to 15 pari**l *per bilhon (EX. 117. p. I). AdditionHlIv. it was suggested hv certain employers that their on*rations be exempted from the requirements of the standard becaure these operations involve only intermittent and low level exposures to benzene. The use of the acric.n level concept should accommodate these concerns in all cases where exposures are indeed extremely low since it snb'tnn'iallv reduces the monitoring of employees who are below the action level and removes for these employees the requirements for medical rtirveillanoe. At the same time, employees with significant overexposure ar afforded the full protection of the standard.'' (Emphasis added ) 43 Fed. Beg., at 5942. The Government also Mate* that it ia OFH.Vs policy to attempt to quantify benefits where:er po-sible. While this is :-ortai")v n reasonable position, it is not consi-tent with OSH .Vs own view of its dutv under Sfi (bl(5). In light of the inconsistencies in OSHA's position and the legis lative history of the Act, we decline to defer to the Agency's interpretation. this interpretation to hold that .the Act also requires the Agency to limit its endeavors in the standard-setting area to eliminating significant risks of h.-.rm. Finally, with respect to the lpg-slative history, it is im portant to note that Congress repeatedly expressed its concern about allowing the Secretary to have too much power over American industry. Thus, Congress refused to give the Sec retary the power l.o shut down plants unuateroily because of an imminent danger, see Whirlpool Corp, v. Marshall, ----U. S. ------, and narrowly circumscribed the Secretary's power to issue temporary emergency standard?/-' This effort by Congress to limit the Secretary's power is not consistent with a view that the mere possibility that :-ome employee some where in the country may confront some risk of cancer is a sufficient basis for the exercise of the Secretary's power to require the expenditure of hundreds of millions of dollars to minimize that risk. D Given the conclusion that the Act empowers the Secretary to promulgate health and safety standards only where a significant risk of harm exists, the critical issue becomes how to define and allocate the burden of proving the significance of the risk in a case such as this, where scientific knowledge is imperfect and the precise quantification of risks is therefore impossible. The Agency's position is that there is-eubatantial evidence in the record to support ite conclusion that tlitre is rto absolutely safe level for a carcinoe-n and that, therefore, the burden is properly on industry to tirove, apparently beyond a shadow of a doubt, that there is a safe level for benzene expo sure. The Agency argues that, because of the uncertainties in this area, any other approach would render it helpless, forcing it to wait for the leukemia deaths that it believpg are likely to occur0" before taking any regulatory action. We disagree. As we read the statute, the burden was on the Agency to show, on the basis of substantial evidence, that it is at least more likely than not that long-term exposure to 10 ppm of benzene presents a significant risk of material health impairment. Ordinarily, it H the proponent of a rule or order who has the burden of proof in administrative proceed ings. See 5 Lr, S. C. 55fi (d). In some cases involving toxic substances. Congress has shifted the burden of proving that a particular substance is safe onto the party opposing the pro- lMi. t'lori'la Peach Grmvm Aim.. Inc., v. Dept, of Lctbor. tSU F ?<1 120, 130, and it. 16 (CA5 19/4), the court noted that Congress intended to restrict the use of emergency standards, which are promulgated without any notice or hearing. It held that, in promulgating an emergency standard, OSHA must find not only a danger of exposure or even some danger from exposure, but a grave danger from exposure necessitating energenev action. Accord, Drij Colors Mfrs Awn., Inc v. Dept, of Labor. 4S6 F. 2d 9S. 100 (CA3 1973) (an emergency standard must be supported by something more than a possibility that a substance may cause cancer in man). Congress also carefully circumscribed the Secretary's enforcement powers bv creating a new, independent board to handle appeal? frem ri'ntion? issued by the Secretary for noncorripliaru-e with health and safely stand ards. See 29 U, S. C. 5 639-661. 6" As noted above, OSHA acknowledged flint there was no empirical evidence lo support the conclusion that there was any risk whatsoever of riesths due to exposures at 10 ppm. What OSHA relied upon was n theory `hat, because leukemia deaths had occurred at- much higher exposures, some (although fewer) were also likely to occur at relatively low ex-posure*. The Court of Appeals specifically hHd that it? conclusion that the number whs '`likely" to be appreciable was unsupported by the record. See p. 27, supra. 7-10-80 Published by THE BUREAU OF NATIONAL AfFAIRS. INC.. WASHINGTON. D C. 20037 174 OCCUPATIONAL SAFETY & HEALTH REPORTER posed rule."' Tlie fact that Congress did not- follow this course in enacting OSHA indicates that it intended the Agency to bear the normal burden of establishing the need for a proposed standard. In this case OSHA did not even attempt to carry its burden of proof. The closest itcame to recking a finding that benzene presented a significant risk of harm in the workplace was its statement that the benefits to be derived from lowering the Derrnisaible exposure level from 10 to I ppm were "likely" to be "appreciable." The Court of Appeals held that this finding was not supported by substantial evidence. Of greater importance, even if iL were supported by substantial evidence, such a finding would not be sufficient to Rati&fy the Agency's obligations under the Act. The inadequacy of the Agency's findings can perhaps be illustrated best by its rejection of. industry testimony that a dose-response curve can be formulated on the basis of current epidemiological evidence and that, even under the most con servative extrapolation theory, current exposure levels would cause at most two deaths out of a population of about 80.C00 worker? every six years. See n. 38, svpra. In rejecting this test.monv, OSHA made the following statement: "In the face of the record evidence of numerous actual deaths attributable to benzene-induced leukemia and other fatal blood diseases, OSHA is unwilling to rely on the hypothesis that at most tun cancer* every six years would be prevented by the proposed standard. My wav of example, the Infante study disclosed seven excels leu kemia deaths in a population of about 000 people over a 2.5-year period While the Infante study invoked higher exposures then those currently encountered, fire incidence rates found by Infante, together with the numerous other cases reported m the literatnip of benzene leukemia and other fatal blood diseases, makes it difficult for OSHA to rely on the [witness'] hypothesis to assure that statutorily mandated protection for employees. In any event, due to the fact that there is no safe level of exposure to ben zene and that it is impossible to precisely quantify the anticipated benefits, OSHA must select the level of ex posure which is most protr-tive of exposed employees." 43 Fed. Reg., at 5941. There are three possible interpretations of OSHA's stated reason for rejecting the witness' testimony: (1) OSHA con sidered it probable that a greater number of lives would he saved by lowering the standard from 10 ppm; (2) OSHA thought that saving two lives pvery six years in a work force of 30.000 persons is a significant savings that makes it reasonaide and appropriate to adopt a new standard, or (3) even if (lie small number is not significant and even if the savings may be even smaller, the Agency nevertheless believed it had a statutory fluty to select the level of exposure that is must protective nf the exposed employees if it is economically and technologically feasible to do so. Fvpn if the Secretary did not intend m rely entirely on this third theory, his construc tion of the statute would make it n.-ma.-r for him to do so. o'-ilii'oiimotter' i9'/r'.'ic Fund, !t*c v KPA, 17C I1. S. ,\;rp. D C. 43. 5-48 F. 2,1 MS, 1004, 20X2--10JS (1077), cert. denied, 4.3! U. S. t'25, where the rcirt r-bet-'d the argument that the EPA hits the burden of proving that a pesticide is un.-afe in order to suspend its regisfr.mon under the Federal Imecticide, Fungicide and 'Rrnlertieidrt Act. The court noted that Congress hud dehherrilely shifted the ordinary burden .if proof under the APA, requiring manufacturers to establish tit.* con tinned safety cf their predicts. Moreover, lie made no express findings of .'act that would sup port his 1 ppm standard on any les* drastic theory. Under these circumstances, we can hardly agree with the Govern ment that OSHA discharged it? durv under the Act. Contrary to the Government1* `'onicntions. imposing a burden on the Agency of demon.-tratiiig a significant risk of harm will not strip it of its ability to regulate carcinogens, nor will it require the Agency to wait for deaths to occur before taking anv action. First, the requirement- that a "significant" risk be identified is not a mathematical straitjacket. It is the Agency's responsibility to determine, in the first instance, what it considers to be a "significant'' risk. Some risks are plainly acceptable and others are plainly unacceptable. If, for example, the odds are one in a billion that a person will die from cancer by taking a drink of chlorinated water, (he risk clearly could not be considered significant. On the other hand, if the odds are one in a thousand that regular inhalation of gasoline vapors that are two percent benzene will he fatal, ft reasonable person might well ec'--ider the risk significant and take appropriate steps to dceiea- or eliminate, it. Although the Agency has no duty to calculate the exact probability of harm, it does have an obligation to find that a significant risk is present before it can characterize a place of employment aa ``unsafe." Second, OSHA ia not required to support its finding that a significant risk exists with anything approaching scientific cer tainty. Although the Agency's findings must be supported by substantial evidence, 29 U. S. C. $ Gao (fJ, 5 G (b)(5) specifi cally allows the Secretary to regulate on thp basis of the "best available evidence." As several court? of appeals have held, this provision requires a reviewing court to give OSHA some leeway where its findings must be made on the frontiers of scientific knowledge. See Industrial Union Dept., AFL--CIO v. Hodgson, -- U, S. App. P. C.----- , 499 F. 2d- 467, 476 (1974); Society of the Plastics Industry, Inc. v. OSHA, 5C9 F. 2d 1301, 180S (CA2 1975), cert, denied. 421 U. S. 9G2. Thus, so long as they are supported by a body of reputable scientific thought, the Agency is free to use conservative assumptions in interpreting the data v.ith respect to carcino gens, risking error on the side of over-protection rather than under-protection.'05 1 * * * 01 In hi-r di.-s-nting opinion, pn.*t. at if>, Mu. .N.'<rirr MatisUvi.l state-: th.it "when the question involve*- dete:imiii.tinn of die acoi-td- al.le level of n-k. the uliin.ue ilcti-ion mn-I !:<< s-arily l>e ba-cd on Con.-idiTitions of policy :i.i tve.'l ay *Ui|lir:<-;ifly veriri.ilile f-i< -s tujl lift* fri.iiialioni cun at luo.-l define ttic ri-k in -tittle .%Uui*iu-;il way: the jiabuK-iil nb-i;,.t that n-k is tolerable rniirmt In- based rulcly on :i ri-o- lunoii of die fill-1' U"c agree. Thus, white die Aguuy nsn-t support it? hiidinz that j certain ii v, | tif risk exists bv sub-1 initial evidence, ye r*\-ri.ciizt. th.u j:* defc-nniitatiou that a particular level nf risk is "-ig- lufii - u" will b-r ha-il largely on pi.'liry ton-iileralitm.-. At this point vc leave no rcf-I to feuvh live i-sver of what level of scrutiny a reviewirg could -boitltl apply to the latter lype of ib-termination. '-1 Mh. Jc-TICE M.iHdU.viL states that, under our approach, `.he agency ilin-t i-i flier v: i ll for deaths to occur or ItinJ "deceive the public'1 bv mak ing a tu-tr.dlv iiK-ahiii-lr--- dclrniiitintii'n of -i-tnilicain e ba-c'l on totally iii-nl:<]n.Uc ia i,I, n> c ,Mn. Jc.s-no-: Man* mix's view, however. ?<*(.* on the i-ranioii. i i.iui-e dial die onlv ria.-uo t'SHA did nut .1 *ti-:tj|it to C]11a ill rl v lu-fri!:r - in I In - ca*i- vv a.- In-cause d vfmld nol - do .*0 in aiiv rr-i-nnal'lc manner. A* 1 In- <ii-, ii.--i,u< of the A^i-in-v's rejeel ton ,>[ .-m iudn-fry muitipl at f.n nmlu in :l dn*,-n-.|xrii.-a- curve .............. Into. however, set* pp 42-43 snpni tic Acv-ni yU Tojccl i(>n of tiu-dind* ,-ucli ay ilu*i*-rc.-p-pii-t.- curves was 1< I al has! ill part Oil its view that linlliiug less tii.xil ab-nluic -afetv would sitfiiiT. 7-to-ao Published by THE BUREAU OF NATIONAL AFFAIRS INC. WASHINGTON. O C 20037 SXL CURRENT REPORT 175 Finally, the record in this case and OSHA's own rulings on other carcinogens indicate that there axe a number of ways in which the Agency can fli&ke a rreiunal judgment about the relative significance of the risks Hs-'ociated with exposure-to a ulio tvere unusnliy su?rttptiblt to benzene could be removed from exposure before tboy lu. l sufTcred any j)ernmnent cin1ltage.'', E particular carcinogen** - Because our review of this case !.as invob-ed a more detailed It should also be noted that, in setting a permissible expo sure level in reliance on less-thri-perfect- methods, OSHA would have the benefit of a backst-'p in the form of monitor examination of the record that is customary, it must be emphasized that we have neither made any factual deter* minatioiis of our own, nor have \m- rejected any factual find ing and medical testing, Thus, if "SHA properly determined ings made by the Secretary. We express no opinion on what that the permissible exposure limit should he set at 5 ppm, it factual findings this record might support, either on the basis could still require monitoring and medical'testing for em of empirical evidence or on the basis of expert testimony; nor ployees exposed to lower levels."' By doing so. it could keep do we express any opinion on the more difficult question of a fniipiant 'heck on tin* validity of the assumptions made in developing the permissible vxpnu.re limit., giving it a sound C' ideatinry basis for deiTva- lug the limit if it was initially set what factual determinations would warrant a conclusion that significant, risks are present which make promulgation of a new standard reasonably necessary or appropriate. The too high.-" Moreover, in 11 1 > wav it could ensure that- workers* 111 .standard must, of course, be supported by the findings actually made by the Secretary, not merely by findings that we believe he might have made. * Frir c\';ilii|>V. in dll' coke riven l tui.-.-ini r-- U :i ml:i rri. 0?HA liaj c:iJoi- i.ite.l l tin I '_'t.liOn e\jt.-etl iukv men "inker-, li;ul ,m exee-.- mur- f.xJJf <if rjivr -Of) ,ni(| llr.tf lit.- | r^>| n>.-crl -i.'ind.i r! J;l rifl. 'Veil vJillliliil 11* die fi-k vntm-lv. 41 Keil llc<>. 4i>742, ir750 i'O'-i 22. 1'I7I7I, uplinkl in /rOII .( Si.-if //>*(. v. OSHA. 577 F. 2-1 St'5 (CAA J97S), >ert. peiirlinic. Nn. 7S-0I1'. pi li<-iriit^. on iliv .nki- oven eini.-.-iuii- standard, die Council on Wnjrv :isid 1'iiec Stability c-,1 iin.'iid I lei I S to .15 lives would he -;n-d eli ve.ir. nut of an estitnaIoI ]>pui:ition of 14.(XlO work er-. a- a remit of tlie projni-ed 't.uul.ird. Although noting that the raliiitr of hem tit- would \>irv d' |ieinlin" on the n.-.-uimpli'iTi.' u.'ed. OSHA did not make a findiii" a- to wheilmr it- own -tuff e-tnaiUe or CWTS's was correct, O'l tin- "rni.inl that it w.1- not n quircl to r|ii.iiilifv llie expected bi in fit- of tlm Man.lard or to weigh tluee bciirlit' :iga';u,-t the projected en-ti. In ntln r (riieveditn:.'. I'm Aa'iv- ha- leid . cixmI de-d of data from aiiiinal in | lerinn n's nji w lix li it , m'.ld lia-e a en m )i i.-i, >n on the Mgiiific.itu'e of the risk For v\niiii-li . the neord on the um] (Murid? standard indic.ited that a -iyiiifie.ilit ini lilt n-r nf a III ill d- h.i d de'i iu|K'd tumor'' of t lie liver, hing and 'kin wln n lln-v were e\yo-cd tu 5U ppm of 'invl chloride t)' it a pern nl of II month.'. One hnnd n-d mi I M 2no anstmils died during tli.u period. :;!> Fix I. Ueg .'liV-IHt, o.'j.v*! fOet. 4. 1977). Similarly, in a l!>74 -'andard reeniaiim; 14 can iimm n-\ OSH A found that, one of the Mih'taiu-e; had eali-i-.f filin' cancer in Inin- <>r rats at 1 jiprn ami C'Tti 0 1 ppm, while another had i.iu.-cd tnnior- ,u SUCf. of the animals sub jected to high tlo.-es. 39 Fed. Reg. 37.V1, :>7a' (fan. 29, 1074), upheld in Si/W/i ,T ir Oci/iii`'(- ('`/i/nrii -.1 (V/ca A.<.<tr v /Jiviiir-ii. 5ltu h. dd 1155 (CAJ HI74). eert. denied. 120 l'. S. UT.!. .mil 500 F 2d JSu (CAJ 1974), tcfl. denied, 423 U. S. o-IU 111 this ra.-C the \eein V did not hive the tern fit of animal studies, be- eau-e ---lelt r-t -- lia'i- b'v:t unable a- wT to anhi' e leukemia ill (Vj'ieriiiieiital aiiiiual- as a n-'ii'l of hi-nzi-ne i-'pn-iirc It did, liowev-r, have a fair atiiouut of epidi-mioloeii-al mid'Uiee, ineludtiij both po-it ive and negati'.e Studi'-Si. Al'lmuith the Aeetn v .'lal'il that tile\ idem tf was insullieietit to cont rn< 1 a previse correlation between e\jy\-ure level < and eaiieer ri'ks, iL wuuiil at lea-t Iw Intpfnl in ih-tv.-inining whetlnT it is mule likely than not (h i* there i- :t .'i"iii/h\iiit ri-k :it HA ppm. -Se,< (7.1 K Coq, V. OSHRC. IS'! U. S App. D C. ?n. `.'(il K. 2d i:j (1977), where the Court upheld the asbe-to* standard insofar as it re quired employers to provide medical examinations for etniiloyetr' expoed to any asbestos fibers, even if they were exposed to concentrations below the permissible exposure limit. The respondent industry representatives have never disputed 0?H Vs power to require monitoring mid niedic.il examinations in general, although they did object to some of the specific requirements impo-ed in this ea'e. See n. 30, supra. Because of our disposition of tlie ca,-e, we have no occasion to pn.ss on the<e speiific ohjeetiiuis or to determine wliat cost- benefit considerations, if anv, j,hotild "O'eni the Agency's imposition of such requirementJ. *" Tlu- is precisely the type of infonuatii'ii-gal tiering f'liietion that Outress had in mind when it enac|| 6 fa) (7), w hii-h empowers the Ferre tary to require niediv.il examinations to be furiu-hed to emplos'ee? P\|-osed to certain hatard' mid potential hazards "in orrh*r to most effectively de- tonnifi** wdiether the heollth of .-ui'li i-aiploj ees is adwrsvlv alfected by sie-h exposure." Sve Legis. Hist., p. 147. In this case the record makes it perfectly clear that the Secretary relied squarely on a special policy for carcinogens that imposed the burden on industry of proving the existence of a safe level of exposure, thereby avoiding the Secretary's threshold responsibility of establishing the need for more stringent standards. In so interpreting his statutory author ity, the Secretary exceeded his power. IV - Throughout the administrative proceedings, the dermal con tact issue received relatively little attention. In its jwoposed rule OS FI A recommended a total ban on skin and eye contact with liquid benzene on the basis of its policy that "in dealing with a carcinogen, all potential routes of exposure (i. e., inhalation, ingestion, and skin ab--rption) [should] be limited to the extent feasible." 43 Fed.'Reg., at 5943. There was little opposition to this requirement- at the hearing on the proposed rule, apparently because the proposed rule also excluded from both the permissible exposure level and the dermal contact ban work operations involving liquid mixtures containing 1% (and after one year, 0.1%) or less benzene. In its final standard, however, OSHA eliminated the per centage exclusion for liquid benzene, on the ground that there was no predictable correlation between the percentage of ben zene in a liquid and the airborne exposure arising from it. See n. 18. supra. Although the extent to which liquid benzene is absorbed through the skin is conrededly unknown, OSHA also refused to exempt any liquids, no matter how little ben zene they contained, from the ban on dermal contact. In support of this position it stated that there was no evidence to "suggest that the absorption rate depends on the amount of benzene present in the liquid." 43 Fed. Reg., at 59485949. After the permanent standard was promulgated, OSHA received a number of requests from various industries that the percentage exclusion for liquids containing small amounts of benzene be reinstated. Those concerned with airborne exposures argued that they should not be required to monitor workplaces simply because they handled petro!eum-hsed ,,r III i(- <-\]il:ln.ition of tin* film? 'Iiind.irtl OFHA nolwl Unit lint.- n:ix some fe?timonv that blood abnormalities would riisnppe.ir pft?r exponirc hud 43 F^d n<*2., 394fi. A-.iin, however, OFI1A 7<uu'"d fo rely on iliv hvputhe-is thnt this would always occur. Yet, in requiring mi'diml exniTiinationi of employe*'! exposed to between 0 5 ppm mvi 1 ppm, 05HA was essentially providing itself with I he imc kind of backstop. 7.IO-8O Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. D.C. 20037 SAL 000019233 .4A --y*---- 176 products in which benzene is an unavoidable contaminant. Others concerned with the dermal contact ban made similar arguments. In particular, tire manufacturers argued that it was impossible for them- to comply with the ban because gloves cannot be worn during certain tire-building operations in which solvents are used and solvents containing absolutely no benzene are not commercially available. Because of these requests, OSHA held a new series of hear ings and promulgated an amendment to the rule, reinstating the percentage exclusion, but lowering it from the proposed lfo to 0.5To. The Agency did. however, provide for a threeyear grace period before the esdu: :on dropped to 0.1 r/c. rather than the one year that had originally been proposed. In explaining its amendment, OSH.-* reiterated its policy with respect to carcinogens, stating that, because there is no abso lutely safe level for any type of exposure, exposures by what ever route must be limited to the extent feasible. For air borne exposures, a zero permissible exposure limit had not. been feasible. However, in most industries a b3n on any der mal contact was feasible since compliance could be achieved simply by the use of protective clothing, such as impermeable gloves. The Agency recognized that the dermal contact ban could present a problem for tire manufacturers, but stated that the percentage exclusion would alleviate the problem, be came solvents containing 0.5^ or less benzene were available in sufficient quantities. Although it noted that solvents con taining 0.1 fc or less benzene were not then available in quan tity, the Agency stated that a three-year grace period would be sufficient to "allow time for increased production of solvents containing lower amounts of benzene and for development and evaluation of alternative methods of compliance with the standard's dermal provision." 43 Fed. Reg., at 27068-2796P. The Court of Appeals struck down the dermal con tact prohibition on two grounds. First, it held that the record did not support a finding that the ban would result in cua.utifiable benefits in terms of a reduced leukemia risk; therefore, it was not "reasonably necessary" within the mean ing :.f 3 3 IS) of the Act. Second, the court held that the Agenz-.-'s conelurion that benzene may be absorbed through zhe skin was not based on the best available evidence as re quired by 5 G (b)f5). 5SI F. 2d, at 505-506. On the second ground, the court noted that the evidence on the issue of absorption of benzene through the skin was equivocal, with some studies indicating that it could be absorbed and some indicating that it could not. AD of these studies were rela tively old and the only expert who had testified on the issue stated that a simple test was now available to determine, with a great, deal of accuracy, whether and to what extent absorption will result. In light of 6 (b)(5), which re quires the Agency to promulgate standards on the basis of the "best available evidence" and "the latest available scien tific data in the field," the court held that where there is uncontradictcd testimony that a simple test will resolve the issue, the Agency is required to acquire that information before "promulgating regulations which would require an established industry to change long-followed work processes that are not demonstrably unsafe.'' 5S1 F. 2d, at 508. While the court below may have been correct in holding that, under the peculiar circumstances of this case, OSHA was required to obtain more information, there is no need for us to rondi that issue. For, in order to justify a ban on dermal contact, the Agency must find that such a ban is "reasonably necessary and appropriate" to remove a significant risk of harm trem such contact. The Agency did r.ot make auch a finding, but rather acted on the basis of the absolute, no-risk OCCUPATIONAL SAFETY 81 HEALTH REPORTER policy that it applies to carcinogens. Indeed, on this issue the Agency's position is even more untenable, inasmuch as it was required to assume not only that benzene in small dow is a carcinogen, but also that it can be absorbed through the skin in sufficient amounts to present a carcinogenic risk. These assumptions are not a proper substitute for the findings of a significant risk of harm required by the Act. TJie judgment of the Court of Appeals remanding the peti tion for review to the Secretary for further proceedings is affirmed. It is so ordered. Mr. Chjkk Justice Bchoek, concurring. Tlvs case presses upon the Court difficult unanswered ques tions on the frontiers of science and medicine. The statute and the legislative history give ambiguous signals as to how the Secretary is directed to operate in chi* area. The opinion by Mr. Justice Stevens takes on a difficult task to decode the menage of the statute as to guidelines for administrative action. To comply with statutory requirements, the Secretary must bear the burden of '`finding'' that a proposed health and safety standard is "reasonably necessary or appropriate to provide sate or healthful employment and places of employ ment." This policy judgment entails the subsidiary, finding that the pre-existing standard presents a "significant risk" of material health imp.'drment for a worker who spends his entire employment life in u working environment where ex posure remains at maximum permissible levels. The Secre tary's factual finding of "risk" must be "quantified sufficiently to enable the Secretary to characterize it as significant in an understandable way." .4/de, at 35. Precisely what this means is difficult to say. But because these mandated find ings were not made by the Secretary, T agree that the 1 ppm benzene standard must be invalidated. However, I would stress the differing functions of the courts and the administra tive agency with respect to such health and safety regulation. The Congress is the ultimate regulator ami the narrow func tion of the courts L? to discern the meaning of the statute and the implementing regulations with the objective of ensuring that in promulgating health and safety standards the Secretary "has given reasoned consideration to each of the pertinent fac tors" and has complied with statutory commands. Permian Busin Area Rate Cases, 300 U. S. 747, 792 (1968). Our hold ing that the Secretary must retrace his steps with greater care and consideration is not to he taken in derrogation of the scope of legitimate agency discretion. When the facts and argu ments have been presented and duly con.-idered, the Secretary must make a policy judgment as to whether a specific risk of health impairment is significant in terms of the policy objec tive? of the statute. When he acts in this capacity, pursuant to the legislative authority delegated by Congress, he exercises the prerogatives of the legislature--to foemson only one aspect of a larger problem, or to promulgate regulations that, to some, may appear as imprudent policy or inefficient alloca tion of resources. The judicial function docs not extend to substantive revision of regulatory policy. That function lies elsewhere--jn Congressional and Executive oversight or amendatory legislation; although to bo sure the boundaries are often ill defined and indistinct. Nevertheless, when discharging his duties under the stat ute, die Secretary is well admonished to remember that a heavy responsibility burdens his authority. Inherent in this 7-1080 Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. DC 20037 ocoov^ SM- m&aamMa&c&jik CUrtRENT REPORT statutory schema is authority to refrain from regulation of insignificant or dv oii/ii/u^s risks. See Alabama I'oicer Co. v. EPA, -- U. S. App. ------ F. 2u --No. 78-1006, Slip op., flt 41-44 (Dec^^lD79) (opinion of LeveiithM, J ). When the Kdministrativ*jgpg<K>rd reveals only scant or minimal risk of material health impairment, responsible administration calls fur avoidance of extravagant, comprehensive regulation. Perfect safety is a chimera; regulation must not strangle human activity in the search for the impossible. Mr. Justice Powell, concurring in part and in the judgment-. I join Parts I, II, III A-C, ami 1II-E of the plurality opin ion.1 The Occupational Safety and Health Agency relied in large part on its "carcinogen policy'1--which had not been adopted formally--in promulgating the benzene exposure and dermal contact-regulation at issue in this cased For the rea sons slated by the plurality. I agree that iiS 0 (b)(5) and 3 (8) of the Occupational Safety and Health Act of 1970. 29 U. S. C. 055 (brio). 052 (8). must be read together. They require OSHA to make a threshold finding that proposed occupa tional health standards me teasonably i:ee'.vniry to provide safe workplaces. When GSHA acts to reduce existing na tional consensus standards, therefore, it must find that (i) currently |?rmissible exposure levels create a significant risk of material health impairment; and (ii) a reduction of those levels would significantly reduce the hazard. Although I would not rule out the possibility that the nectary findings could rest in part on generic policies prop erly adopted by OSHA. sec McGarit-y, Substantive and Proce dural Discretion in Administrative Resolution of Science Policy Questions: Regulating Carcinogens in EPA and OSHA. 07 Geo. L. J. 729. 754-759 (1979), no properly sup ported agency policies are before us in this case.' I therefor* agree with the plurality that the regulation is invalid to the extent it rests upon the assumption that exposure to known carcinogens always should be reduced to a level proven to be safe or. if no such level is found, to the lowest level that the affected industry cun achieve with available technology. 1 Tlic-f [.-(irtiun.- of (he plurality opinimi primarily j<ldr OSHA's spe cial i-.irriniiiru policy, rather than f.XsHA's arjjynvnt that it also m.nUs evidentiary findings, t do not necessarily agree with every obiorvation in the |il'ir:ihtv opinion etmoeniitii! the presence or absence of such find ings. T also express no view on the question whether a different inter pretation of rhe statute would violate the noudel.-gation doctrine of Sc/teehlrr Pouitru Corft. v. (.'nitetf Ofutej. 2P5 U. S. -195 (2D.15), and Pnuum/1 R-fuit'-ij Cij. v. R'jnn, '_'9d U. S. j-sS (10,1'ri. See port, at --(RkhvijCIst, J., Kiiiilifriic;). "The yci-r'dary uf Labor ju<i|i)iil'.c>tol th<- relevant standard pursuant t-i hr- ilalurorc authority Since U.-MA i- the mjemy re.-isojlsihle far develupiug -u'-h regulations nailer the Scctetary'- iiiie.tiuti, tliis opinion refer- tr> OSHV' r.r `dhe agency" as rie il.vi-imim.ik.-r nia-t directly lUil.-erne,! 'OsHA ha- adoiitcii a formal jxdiey for n jiulatiin; casein.,rtfertivi* Aorrl 2), I'mi. y,-,| p,.a ,-m.j ; ).Ifi _>j_ ii,sin J|,a ,io s'ch jx.li.-y ii.cs in i Ih ei whi n 'he a^eney proTinilu'atisI i's h.-nz-air r-g'.ilat'un. More over. tn-'ln-r M:e t'arlii:d dclerimu.iiKxi- nor tin- adiiiini-lraiive juriauit'c', np'ii* which the pnliey re-ls are .-up|K,i |e,f ad.'i|iiatiHy on this record alone. Act .mlinzlvivc hau- no <><-i-.'i-joi> p, con.-idcr the extent to which valid agency |'I|,or- may .-'i|iptt a bad.- for a finding tii.U health n-k- exist ill .particular ra.-e-. ' ". ' ''" ' - ""*)& . . --'. ;* S T* ........ ..... ........ *177 - Tf the disputed regulation were based exclusively on this `'carcinogen policy." I also would agree that we need not consider whether the Act requires OSHA to determine that the benefits of u proposed standard are reasonably related to the costs of ('utu pi int ice. Ante, at o. As die Court of Appeals for the hiftli Circuit tvcogid/t-d. however, OSHA takes the "fall-back position" that its regulation is justified by specific finiliiKis based upon the veluuu ions evidentiary record com piled in this case. SSI F. 2d 493. 503. OSHA found, for example, that {lie number of cancers prevented by reducing permissible exposure levels from ID ppm to 1 ppm "may be appreciable, that "the benefits of the proposed standard are likely to be appreciable.'' ami that the "substantial costs (of the new standard] are justified in light of the hazards." 43 Fed. Reg., at >9-hi-.i!)41. Tims. OSHA found--at least gen erally--that the hazards of benzene eximsure at currently permissible levels are serious enough to justify an expenditure of hundreds of millions of dollars. For me, that finding nec essarily subsumes the conclusion that the health risk is "sig nificant-." If OSHA's conclusion is supported bv substantial ev idence, the threshold requirement discussed in the plurality opinion would be satisfied. As I rent! its opinion, tbe plurality does not consider idjether the a ire i icy's findings are supported by substantial evidence. The Court of Appeals found them insufficient becausejOSHA failed "to estimate the extent of expected benefits. . . jf. 581 F. 2d. at 504. That court apparently would have required OSHA to supply a specific numerical estimate of benefits derived through mathematical techniques for "risk quantifi cation'' or '`cnst-effectjveiM'ss analysis." ' Id., at 504. n. 23; see id., at .51)4-505. 1 <|o not agree with the Court of Ap peals' conclusion that the statute requires quantification of risk in every case. The statutory preference for the "best available evidence," 29 lT. H. O. <i55 (b)(5). implies that OSHA must use the best known techniques for the accurate estimation of risks and benefits when such technique* are available. But neither the statute nor the legislative history suggests that OSHA's hands are tied when reasonable quantification cannot be ac complished by any known methods. See post, at----- (Mahshall. J , dissenting). In this case. OSHA found that "it is impossible to precisely quantify the anticipated bene fits. . . ." 43 Fed. lleg.. at 5941. If this finding is sup ported by substantial evidence, the statute does not prevent the Secretary from finding a significant health hazard on the basis of the weight of expert testimony ami opinion. I do not understand the plurality to hold otherwise. See ante, at 49. For the foregoing reasons. I woultl not hold that "OSHA did not oven attempt to carry its burden of proof" on the threshold question whether exposure to Iwtuenc at 10 ppm presents a significant risk to human health. Ante, at 42. In my view, the question is whether OSH-A successfully car ried its burden on the basis of record evidence. That ques tion in turn reduces to two principal issues. First, is there substantial evidence supporting OSHA's determination that available quantification leohnirpjes are too imprecise to per mit a reasonable numerical estimate of risks? If not, then OSHA lias failed to show that its regulation rests on the "best available evidence." Second, is OSHA's finding of significant risks at current exposure levels suplJorted by sub stantial evidence? If not, then OSHA ha? failed to show that 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. DC. 20037 0C0C1<?2^ SM- 178 OCCUPATIONAL.SAFETY & HEALTH REPORTER the new.- m'lilntioii in ryHt-ojiably iittffssary to provide safe and healthful workplaces. II Although I regard tlio qurftiuii as close. I do not disagree with t)ie plurality's view* that OSHA Jims failed, on this rec ord, to carry its burden of proof on the threshold issues sum marized above. Hut even if one assumes that OSHA properly met this burden, see pv.st, at----- (Mahsh.w.l. J , dissenting), I conclude that the statute also requires the agency to deter mine that the economic eth-rts of its standard bear a reason able relationship to the expected benefits. An occupational health standard is neither "reasonably necessary" nor "feasi ble." as required bv statute, if it calls for expenditures wholly disproportionate to the expected health and safety benefits. OSHA contends that StWl>)(5) not only permits hut ac tually requires it to promulgate standards that reduce health risks without regard tn economic effects, unless those effects would cause widespread dislocation throughout an entire in dustry.* Under the threshold test adopted by the plurality today, this authority will exist, only with respect to ``sig nificant'' risks. But the plurality does not reject OSHA's claim that it must reduce such risks without considering eco nomic consequences less serious than massive dislocation. In my view, that claim is untenable. Although one might wish that Congress had sixfken with greater clarity, the legislative history and purposes of the statute do not support OSHA's interpretation of the Act.* It is simply unreasonable to believe that Congress intended OSHA to pursue the desirable goal of risk-free workplaces to the extent that tire economic viability of particular indus tries--or significant segments thereof--is threatened. As the plurality observ-s. OSHA itself 1ms not chosen to carry out1 * OSHA argues dial $0 (b) (Vi requires it Jo prnmu'g.ife standards that arc ''fi'a.-iMi'" only in the .-t-n.-e th.it fiiev are "callable of .udhi-vemcni"; that is, .idiii-i able "at ).< .trab'c ec.*t with available tfx-luiolcgy." Brief for the Federal Parties 57. The Imirr cimrl. have indicated that a standard i* not ` iiifi-aaiUe" under Ur^HAV test unless it would precipi tate ' ni.is.-ive cnnniiuir di.-lyeaiion'' in tin- alTivtvd industry. See, r. y., A in-ae ijii Frdi-nituu, <,! Labor v. Hrrui.un, 5'tO F. 2d 100, l'J:J (C.A3 1975). in tin- eas.', OctHA sitiipJy asked a cun-uhiitg firm to a.-s-enam the coefs uf compiling with a I ppm standard. See mite, at 11. OSHA then Con cluded dial "the iftiiKUUlr iinpaef of f i oil I] ilia net-] will not , . . threaten the liu.iiirtal welfare of ilit- alFi-cted linn.- or iru* general economy." 4!) Fed. Keg., at .Vj.i'i, Tlio eu.-t of comply mg \vi|i a standard may Ixj 'h'-al.ilj.V' and still tint cea.-i'iinbK rvlaUxl In the benefits eqwcteil. A inalinf.il luring voitip.uiv fer example. may liave financial resources that enable it to paV the OSHA-urdercil eo-t-. But twjK'inlitures for unpro ductive purposes m.iv limit -eriiiii'dy its linmvi.il ability to remain COliljrelitive ami provide jolt. 1 I will no I refloat the detailed siniiniarv of the legislative history con tained m the plurality opinion. Ante, at liA-40. Many of tin- ronsideratUnis llml ihe plurality reins iqMiii < show Congress' coto-ru wjtti nigitifi- cnni harm.- | xTsiuitc me that t 'iingress di<l nut intend OSHA to reduce each s;">'ifie.iin has.mi iiirhoni regard to Haiiieinie cim.-cqiienrs-i. Senator VuiL-iti:s, a stion.-sT of the legislation, .-tali'll tli.it r "Our bill is fair and rea.e'-auV. P :v good-faith effurf to balance the mas! of workers to bi\< . -.df)e a.rl IiimIiIiv wurk enviroitinerii against the requirement of aihi-;w tn fmierion without nniiue inter lirvure.'' Side nmimltee on f_i>.r ni r|u> Seriate Commit toe oil I.iIkit and Public Welfare, Legi-la- ln" Hi-inrv uf the Occupational Safely mid Health Art of 1970, 92d Cuitg., 1st Se.^t . p. laa tt'.iimii Print 1971). There could he ro such "balance" if OSHA were authorized to imis>.-e -talid.ifds without regard to e'oni'imi' con.-ei|iii*iu cs -Imrl of serums .li.-hx ation. Senator Dominick described a preliminary version of 13 (b)(3) as fu!i,.w>: `Whal we weri> trvine (o do in tin- liill . , . was to sav Ihat when we are dealing with tovif agents or pin-icat agents, wo ought to take such Steps as are /eoWi/e mu/ /inn tun,' to provide an attno-plten- within which a per son's health r>r sifetv would not be aiTiated. Unfortunately. vv had surli a sdf-tlofpating policy in ;t!l instances. Ante, at .10. If it did. OSHA regulutioM.-i would impair the ability of American industries to compete effectively with foreign businesses and to provide employment for American Markers," I therefore would not lightly assume that Congress in tended OSHA to require reduction of health risks found to be significant whenever it also finds that the affected indus try can bear the. costs. See supra, at 5, n. 4. Perhaps more significantly, however, OSIIA's interpretation of 5G (b)(5) would force it to regulate in a manner inconsistent with the important health ami safety purposes uf the legislation we construe today. Thousands of toxic substances present risks that fairly could be characterised as "significant." Cf. ante, at 13, n. 51. Even if OPHA succeeded in selecting the grav est risks for earliest regulation, a standard-setting process that ignored economic considerations would result in a serious misallocalton uf resources and a lower effective level of safety than could be achiever! under standards set with reference to the comparative benefits available at a lower cost.' I would not attribute such an irrational intention to Congress. In this case, OSHA did find that the ``substantial costs" of the benzene regulations are justified. See supra, at 3. But the record before us contains neither adequate documen tation of this conclusion, ttor any evidence that OSHA weighed the relevant considerations. The agency simply an nounced its finding of cost-justification without explaining the method by which it determines that the benefits justify the costs and their economic effects. No rational system of regulation can permit its administrators to make policy judg ments wit.!',out explaining how their decisions effectuate the purposes of the governing law, and nothing in the statute authorizes such laxity in this case." i-ince neither the air borne concentration standard nor the dermal contact stand* governing statute, I join the Court's judgment affirming thA judgmeiit of the Court of Appeals. l.t'iEii iji" providing ili.d :m>otic* | until In- assured th.it no one mmld have ;i hazard. ... It Was .111 Ullieali.-tie standard. . . ." Legislative Hi-tnry, xuprir. :it .`Vr> (emphasis added). Senator Dominicks objection jn tin* ''u/ire;ilt.-ik" .-t:i:i'?.iril of rN* fore runner uf ti<i>)(Sf iln--.- nut imply rfinf lie ih-night .`t(S) of the Vt l.ii'Ki'iI 'ii'iu.iiiiivv ruiiviti. .-ice nt ------ (MsusUAi.t,. J.. dissenting). TIj-* Senator Jurilly wg< |.| Ii.iit iiroiia-Kl tlmt btb)(S) )>i iK-ii't*-<l en- tirdi, ante, in .'Jti. if In- hull not ihmigbt tb.it other sections of the Ail r*quir<vt Iv-ilih rv"ii1;ili'iii.-' tbit were leai-oriuhle mid pr.ictiral. `'Ciu'grew-, ims n.-siEiu-d OSHA mi v\tmm*ly dilliculr und complex tusk, and the jp'ida/ire aCTurdi'd OSHA i- ci>ii--iiliT,ibly fe>s fliati clear. The agency's primary n-]>on.-i)}ilii\, refiii ti-il in its title, is to tninim'ue health ami >,,fetv ri.-ks in the workplan' Vi-f the iHuniunie liealtb of nnr highly imlitstriHliM'd .-oriety rcquiri-s a liinb rate of fiiiplmmont and mi adeipnite rtr-jsjiise to increasingly vigorous furvign coiii|M'btion, There ran bv little iloofct that Congress iiilviiditl OAH.V to ImI.iihi- iiasonably the societal iutefr-l in (w.ihii .nul safely with the nlfcn conli/i ting ^o,il of nuunluuiing a strong tia'ioiial econouiy. TFor example, OSHA's renditig of tf (b)(5) rotild force the depletion of an industry'- resources in an effort tn reduce a single risk by sOine speculative amount, even though other significant risks remain uiirt$p<late(]. The decision that- cie-ts jn-iify bcnefil- is largely a t>obi-y judgment deh'g ilrd to OSHA by Congress. When a court n-i iews such judgments under Ihr ''suh-t.uiti.il evidence" standard in,nnlate,l by 2ft U S. C. C3f> (f), the court must tlcterniinc whether (lie r,~ponsible agency lias `'r.iTcfnlly idi-ntififedj . , , (lie n-a.-ons why [ill cfiooM-s to follo'v one couisu rntlier th.ui another" as the ttvisl reasonable method of effectuat ing the puqxjses of the applicable law. {ikIiis'nul Union Orfartment v, Hwlyaun, -- U. S. App. D C.----- , I9U F. 2d 467, 475-7l> (1974). Since OSHA failed to identify its reavnis in this Case, I express no opinion as Co the standard of review that may be appropriate in other situations. 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. D C. 20037 SAL GCCC19 2 CURRENT REPORT Mh. Justice Rehnupist, concurring in the judgment. The statutory provisiqn-at the center of the present con troversy, 5 6(b)(5) of ilte Occupational Safety and Health Act of 1970, states, in .Relevant part, that the Secretary of Labor aik-Ns . . in promulgating standards dealing with toxic mate rials or harmful physical agents . . . shall seL the stand ard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life." 29 U. S. C. 055 (b)(5) (emphasis added). According to the Secretary, who is one of the petitioners herein, 6 (b)(5) imposes upon him an absolute duty, in regulating harmful substances like benzene for which no safe level is known, to set the standard for pc-nni.-sible exposure at the lowest level that "can be achieved at a bearable cost with uvaitahje teihi,ninny." 1 trief for tin- Federal Parlies 57. While tin- Secretary dues nut attempt to refine the concept of "bearable rust." be apparently believes that a proposed >i;iudard b evoumui.-.illy fea>ible sn !<my as its impact "will not be sodi us to tlueati'ii the financial welfare of the affected firms nr flu- general economy.'' -hi Fed, Meg., lit 5039. Respondents leplv, juid the lower court agreed, that ti'b){.)l must be read in light of another provision in the same act. $-1 i>, which defines an "occupational health and safety standard ' as " a standard which requires conditions, or the adop tion .r use of one or more practices, means, methods, operations, nr pruceises. reasonably necessary or appro priate to provide safe or healthful employment and places of employment." 29 U. S. J 652 (8). According tu respondents. * b l b) t o). as tempered by 3 t S), requires the ,Secretary to demonstrate that any particular health standard is justifiable on the basis of a rough balanc ing of costs and benefit?. In considering these alternative interpretations, my col league? manifest a good deal of uncertainty, and ultimately divide over whethci the Secretary produced sufficient evidence that the proposed sumdaid for bm/.ene will result in any appreciable benefit?: at all. This uncertainty, I would suggest-, is eminently justified, since [ believe that this case presents the Court with what has to be one of the most difficult issues that could confront it decision-maker: whether the statistical possibility of future deaths should ever be disregarded in light of tile economic r<:<N of ptovc'itjug those deaths. T would also suggest that tier widely vaiying positions advanced in the briefs of the parties and mi the opinions of Mh. Justice S-,,n:.Nr Th f'ii.t-.i Ii'.sto'k. Mir. Ji stick Powei.l. and Mb. Jrsiirr M \ta mdemonstrate, perhaps better than any other t'ae( i!.-,, i'nimn ss. (lie "ovei iniwnt;l body best suited am I mu? I obiigited U> make tin- choire eonlVon t n ig US 1U this case, has iinptoperly delegated that choice to tile Secretary of Labor and, derivatively, to this (*ourt. 179 r In his Second Treatise of Civit Government, published in 1690, John Locke wrote that "The power of the legislative, being derived from the people by a positive voluntary grant and institution, can be no other than what that positive grant conveyed, which being only lo make laws, and not to make legislators, the legislative can have no power to transfer their authority of making laws and place it in other hands." 1 Two hundred years later, this Court expressly recognized the existence of and the necessity for limits on Congress's ability to delegate its authority to representatives of the Executive Branch: "That Congress cannot delegate legislative power to the President is a principle universally recognized as vital to the integrity and maintenance of the system of government ordained by the Constitution." Field v. Clark, 143 (J. S. 649, .602 (1P92).*- The rule against delegation of legislative power is not. how- ever, so cardinal a principle as to allow for m> exception. The Framers of the Constitution were practical statesmen, who saw that the doctrine of separation of powers was a t-wo-sided coin. James Madison, in Federalist Paper No. XLYII. for example, recognized that while the division of authority among the various branches of government was a useful principle, "the d-.-grce of separation vs Inch :he maxim requires, as essen tial to a free government, can never In practice bft, dulv maintained." '/; This Court- also has recognized that a hermetic seiRng-off of the three branches of government from one another*could easily frustrate the establishment of a national government capable of effectively exercising the substantive powers granted to the various branches by the Constitution. Mr. Chief Justice Taft, writing for the Court in Hampton <* Co. v. Cbntcd States, 276 U. S>. 394 t'1928), noted the practicali ties of the balance that has to be struck: "(T]he rule is that in the actual administration of the government Congress or the Legislature should exercise the legislative power, the President or the State executive, the Governor, the executive power, and the Courts or the judiciary the judicial power, and in carrying out that constitutional division into three branches it is a breach of the National fundamental law if Congress gives up. its legislative power and transfers it to the President, or to the Judicial branch, or if by law ji attempts to invest itself or its members with either executive power or judi cial power. This is not to sav that the three branches are not co-ordinate parts of one government and that each in the field of its duties may not invoke the action of the two other branches in so far as the action invoked shall not be an assumption of the constitutional field of action of another branch. In determining what it may do in seeking assistance from another branch, the extent and character of that assistance must be fixed according to common sense and the inherent necessities of the gov ernmental co-ordination." 276 V, S., at 406. During the third and fourth decades of this century, this Court within a relatively short period of time struck down 1 J. I.ncki, S^orut Tr-ilPr- nf Civil Gnvi'rnmiml r T41 (:500|. Iu the same trr al:>e, LocW ab< wrote llr.it "Tin? Irgi.-lative rannet tran.-frr the power of making l.ms lo any other hamls; for it heiri" b:u a rlulepated power from the people, thev win, haw il cannot pa-a it over to others" Ibid. * A-; earlv 5813, tills Conn Inn! r*msv-!<red aiul rejected an arcumerit that a ^tntme .-nilhorizirg the I're-.n!eni to terminate a trade emh-ireo wi Britain and Franco if tho.-* two animus ecus**! viul.itioe "the neutral commerce of the United States" lielepalHt loo timeli (h-civt'on to the Executive Branch. See The J{nij Aurora, 7 Crancli 3>2, -I"'!, '>V> (1SJ3V. 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. DC 20037 1*3 237 S*L cco 180 OCCUPATIONAL SAFETY & HEALTH REPORTER several acts of Congress wu the grounds that thc-v exceeded the authority nf Congress under the Commerce Clause or under the nonJck-guliuit principle of separation of jtowers, iiud at tile same time struck down state statutes because they violated "substantive" due process or interfered with inter state commerce. See generally R. H. Jackson, The Struggle for Judicial Supremacy 4S-123 (1949). When many of these decisions were later overruled, the principle that Congress could not simply transfer its legislative authority to the execu tive fell under a cloud. Yet in my opinion decisions such as Panama Refining Co. v. Ryan. `293 V. S. 3SS (1935), suffer from none of the excesses of judicial policymaking that plagued some of the other decisions of that era. The many lat-r decisions that have upheld congressional delegation? of authority to the Executive Branch have dune so largely on the theory that Congress may wish to exercise its authority in a particular held, but because the field is sufficiently technical, th.c ground to he covered sufficiently large, :md the Member? of Congress themselves not necessarily expert in the area in which they choose to Icgisiate. the most that may he asked under the separatiem-of-powers doctrine is that Congress lay down the genera! policy ami standard? that animate the law, leaving the agency to refine those standards, "fill in the blank*" or applv the stand uds to particular cases. The.-o decisions, to my mind, simply illustrate die principle Flal-ed more than fifty years ago by Mr. C lui f .1 mtice l aft that dele gations of legislative authority must he judged "according to common sense and the inherent necessities of the governmen tal co-ordination." 270 I'. v. at 406. Viewing the legiriatiuu at issue here in light of the*e prin ciples. I believe that it fails to pass muster. Itcad literally, the relevant portion of SGfbjC;)) is completely precatory, admonishing the .Secretary to adopt the most protective stand ard if he can, hut excusing him from that duty if he can't. In the case of a ha/.ai Inns substance for which a ''safe'' Ipvel is either unknown or impractical, tin: language of > 0 (b)(5) gives the Secretary absolutely no indication where on the Con tinuum of relative safety lie should draw his line. Especially hriil of the importance of the interests at stake. 1 have doubt that the provision at issue, standing alone, would \ jolate tin' doctrine against unojuali/vd delegations of legisla tive power. For me the remaining quisthm. then, is whether additional standards are ascertainable fioin the legislative In.sUny or statutory context of S(iib)(5) or. it not. whether such a stain l.irdlc-s delegation was justifiable in light ol the "inheient necessities" of the situation. H One of die primary sources looked to by this Court in adding gloss to an otherwise broad grant of legislative authority is the legislative history of the statute in question. The opin ions of Mu. JoriCK Sti-:\>. nu and Mu. .Ir.-stick Maks hall, how ever give little inrnc than a I in of the hat to the legislative origins of 6 (h) 1 51. Such treatment is perhaps understand able. riiu'P the Icgi-latim hi.-tory of that section, far from shedding light on what important policy choices Congress w as making in (be statute, give? one the feeling of viewing the congressional purpose "hv the dawn's early light." The precursor of $ 6 (h it 5) was placed in the Occupational Safctv & Health Act uf 1070 while that bill was pending in tin- House Committee on Education and Labor. At that time, the section read: "TIip Secretary, in promulgating standards under this subsection, shall set the standard which most adequately as-nie*. on the had? of the bc--t available professional evi dence. that no employee will suffer any impjdnncnt of health, or functional capacity, or diminished life expectenev ev**n if such employee has regular exposure to the ;!:i?ard .jit with bv such standard for the period of hia w.irkimz ur> Legislative History. Occupational Safety A: Health Act of 1970. 92d Cong. 943 (hereinafter Leg. Hut.). Three aspects of tins original proposal are particularly sig nificant. First, ami perhaps most iinjx>rtautly. as originnllv introdm-ed the provision contained no feasibility limitation, providing instead that the Secretary "shall set the standard which most adequately assures" that no employee will suffer harm. Second, it would have requited the Secretary to pro tect, employees funn "any" impairment of health or functional capacity. Third, on its face, although perhaps not in its intent, the provision applied to both health and safety stand ards promulgated under the Act.1 There can he little doubt that, at this point in its journey through Congress. SO (h)(5) would have required the Socictary, in regulating toxic sub-dances, to set the permissible level of exposure at a safe level or, if no safe level was known, at /(to. When the Fcnntc Cnimmllet* on Labor and Public Welfare considered a provision 'identical in almost all re spects to the House \ i-ision. hnwv< r. Senator davits object*! that the provision in question "might be interpreted to require absolute health and safety in all case?, regardless of feasi bility. .. ." Leg. Hist. 197. See also id., at 4IS. The Commit tee therefore amended the bill to provide that the Secretary "shall set the stan/lard which most adequately and feasibit/" assured that no employee would suffer any impairment of health. Id., at 242 (emhpasis added). The only addi tional explanation for this change appeared in the Senate Report accompanying the bill to the Senate floor.. There, the Committee explained that ". . . standards promulgated under $ 6 (b) shall repre sent feasible requirements which, where appropriate, shall be based on research, experiments, demonstrations, past experience, and the latest available scientific data. Such standards should be directed at assuring, so far as possible, that no employee will suffer impaired health or functional capacity or diminished life expectancy, hy reason of the exposure to the hazard involved, even though such expo sure may be over the period of his entire working life." Leg. Hist. 147 (emphasis added). Despite Senator davits' inclusion of the words "and feasi bly" in tlic provision, participants in the floor debate immedi ately characterized SfiiMi'5) as requiring the Secretary "to establish a utopia free from any hazards" and to "assure that there will not be any risk at all.'' Leg. Hist. 4SO--4S1 (Re marks of Sen, Dominick ). Senator Paxbe stated: "When we come to saying that an employer must guar antee chat such an employee is protected from any possi ble harm. I think it will be one of the most difficult areas 5 Pi -poiKlciils anzuc ci:ii, licqul.- it* .-Mii.nriy gi-ne-r.al apnliratirn, )i*j iinri'i 'l wTiikm of It (Mdil .t. iiiMly ich m-d only to health i<-(h o|>jiu-<*il to safely luix.ini.s. Se. Uriel fur lti--.{xiiul-m!i alv-filv In support of this proim-iliim. they rile a portion of the legislative hi/tory where- ilir Ilmne Cotrimitiec on JLlmation .uvl Labor stated that the proposal version of t>(b)(j) would apply when the Secretary ?et. an `'ocrup.-itional health st.iwLril.'' Leri-h'tivc Hi-tnry, Omipniionul Safety A Health Art of lf70, (Tour, -44*1 (hereinafter 1.CR. H irt ). 7-10-80 Published by THE BUREAU OP NATIONAL AFFAIRS. INC.. WASHINGTON. DC. 20037 a19 ------------------------ -- ,i|i^-|in irfiraii I'ni.i ritilfc ... life**. j- CURRENT REPORT we are going to have to ascertain. ... I believe the terms that we are passing back and forth are going to have to be identified." Leg. H|^gtfU5. In response to these coh^mis. Senator Dominick introduced a substitute for the proj>qi<^;pTQVision. deleting the sentence at issue here entirely. Ifpiexplaincd that his amendment would delete . . the requirement in 5 6(b)(5) that the Secre tary will establish occupational safety and health stand ards which most adequately and feasibly assure to the extent possible chat no employee will suffer nny impair ment of health or functional rapacity or diminished life expectancy even if the employee lias regular exposure to the hazard dealt with by the standard for the period of hia working life. "This requirement is inherently confusing and unrealis tic. It could be read tc n-q 'ire the Secretary to ban all occupations in which there remains some risk of injury, impaired health, or life .-xpeotancy. In the cose of all occupations, it w li! be ijuj.-m-sibfir to eliminate all risks to safely and Ih-vjUIi. Tima, the present criteria could, if literally applied, close every business in this nation. In addition, m many cases, the standard which might most 'adequately' and 'feasibly' assure the elimination of the danger would be the prohibition of the occupation itself. ``If the provision is intended ns no more than an admonition to tin* Sccnd.n y to do his duty, it PCCtns mint er5-:)i y and could, if doomed advisable be included in the legisi.it ive h idury i 'Vipmisis in original.) Leg. Hist. 367 Kwutually. Senator Uumiunk and his supporters settled for the present language of >b*Ul(oj. This agreement re sulted in three changes hum the original version of the provi sion as nmend'-d by Senator Javits. First., tiie provision was altered to state explicitly that it applied only to standards fur "toxic mat-iials or harmful physical agents," in apparent contrast with safety standards. Second, the Secretary was no longer admonished to protect employees from "any'1 impair ment of their health, but rather only from "material" impair ments. Third, and most importantly for our purposes, the phrase "most adequately and feasibly assures'1 was revamped to read "most aiuquatdy assures, to the extent feasible!.]" Wo have been presented uith a number of different inter pretations of this shift. According to the Secretary. Senator Dominick recognized that he could not delete the seemingly absolute requirements of 5 6(b)(5) entirely, and instead agreed to limit its application to toxic materials or harmful physical agents and to specify that the Secretary was only to protect employees from material impairment of their health. Significantly, the Secretary os.-erts that hi mandate to set such standards at tin- safest level technologically and eco nomic;dly achievable remained unchanged by the Dominick Amendment. Aecuidmg to the Secretary, the change in lan guage from "moil adi-qual'dy and feasibly assures to "most adequately assmes. to the extent fca>ibh-.'' rcpiescntcd only a slight shift in ejiipltii'if. perhaps suggesting "a preference for health piotec;ion ovei cost .'' Brief fur the Federal Parties ~n. Sec also i'l.. at .">! Mu. Jtvt n y M.\its.HAj.i, reads tins history quite differently. In his view, the version of $ <1 ( h ) 15) that reached the Senate Hour d'd not 'Yleatly embody; | (In- feasibility requirement" and thus was s.mukIIv criticized a? being unrealistic. See , a) (i. It was only a? a lesult o! the flour amendments. 181 which replaced "nio.-t adequately and feasibly assures" with . "most adcquuiely ;i.->ure>. to the extent feasible."' that (lie Secretary ch-nrh. was ainliurizvd (o reject a standard if it proved techiioh*" ieallv or eeinioniicallv iiitca;ible, See also rtf., ;il I.'.}. `24. and h. 34. Kespuiuients east yel a thiisl light on these event?, focusing upon a few place? in the legislative history where the words 'feasible'' and ''reasonable'' weic u.-etl more or less interchangeable. See Log. Hist. 3S-40; 115 Cong Roe. 22517 (Aug. 6. l!)6'i) (statement of Sen. davits), ft is their contention that, when Congress Said "feasible.'' it meant cost justified. According to respondents, who agree in this regard with the Secretary, the meaning of the feasibility requirement did not change substantially between the version that left the Senate Committee on Labor and Public Welfare and the version that was ultimately adopted as part of the Act. To my mind, there are several lessons to be gleaned from this somewhat ervptie legislative history. First, as pointed out by Mu. .)istick M uish.uj.. to the extent that Senator Javits. Senator Dominick. and other meniiters were worried aboul imposing upon (lie Senetary the impossible burden of assuring absolute safely, they did not view 5 -i (S) of the Act as a limitation on that duty. I therefore find it difficult to accept the conclusion uf the lower e.mrt. a? eudiellbhcd by respondents, that 5 3iSi aets n = a general check upon the Secretary's dtifv under > (i ( b )(.'> i to adopt the most [rroUljrttve Standard feasible. ict Second, and more importantly. 1 believe that the legislative history demonstrates that the feasibility requiremcijt, as employed in 5 0(b)(5), is a legislative mirage, appearing to some members but not to others, and assuming any form desired by the beholder. 1 am unable to accept Mr. Justice Marshall's argument that, by changing the phrasing of 5 6(b)(5) from "most adequately and feasibly assures1' to "most adequately assures, (o (he extent feasible," the Senate injected into that section something that wasn't already there.* If I am correct in this regard, then the amendment intro duced by Senator Javits to relieve the Secretary of the duty to create a risk-free workplace left Senator Dominick free to object to the amended provision on the same grounds. Per haps Senator Dominick himself offered the aptest description of the feasibility requirement as "no more than admonition to the Secretary to do his duty. . . ." I,cg. Hist. 367. In sum, the legislative history contains nothing to indicate that the language "to the extent, feasible" docs anything other than render what had been & dear, if somewhat unrealistic. 4 The legislative history imlc-ati-y strongly that Senator Dominick him self saw little, if any, difference between the phrase* "most adequately and feasibly assures" and ''meet adequately assures, to the extent feasible." In the course of his earlier attempt to delete tfie first sentence of Jti (b) (5) entirely, he paraphrased the tmatnciKh-j versiun of tliat section ;i requiring the Secretary to promulgate standard? jliat '`ino?t adequately and feasibly assure to the i-rfcr-f pusable" that no employee would sutler harm. See Leg. Hist. 3d7 lempha-i-. added) Unless Pernuor Dominick found a significant difference Ix-tween the words "possible" yn,] "feasible," it is clear that there is little iliffiwcno* between Senator Domiiiii k's per ception of what tile unamended section required in the way of feasibility and whai that section required ifier hi.* ameodtneni * Section 2ll (c)(21(A> and (B) uf rhe rieati Air Act, as amended on Her. 31. I(i70, authorize* the Knviromneni.it Protect inn Agency to regu late. control, or prohibit automotive fuel additives after "consider:!ikm of other. technologically or ecumwntceu'fi/ feasible means of achieving emission standard* . . 42 U. S. C. 7WS (r)f2)(A) (emphasis added). 7-1080 Published by THE BUREAU OF NATIONAL AFFAIRS. INC., WASHINGTON. D C. 20037 S M- ODOCl 2 39 182 standard largely, if not entirely, precatory. There is certainly nothin* to indicate that these words, as used in 6 (b) (5), are limited to technological awl economic feasibility. When Con gress has wanted to limit the concept of feasibility in this fashion, it has said so, as is evidenced in a statute enacted the same week as the provision at issue here.' T also question whether the Secretary wants to assume the duties such an interpretation would impose upon him. In this case, for example, the Secretary actually declined to adopt a standard lower than 1 ppm fur some industries, not- because it was economically or technologically infeasible, but rather because "different levels for different industries would result in serious administrative difficulties.'1 Appx. to Pet. for Cert., at l8Sa. See ah-m ante, at UP-40 (plmality opinion i. If 5 6(h)(5) authorizes the Secretary to reject- a mote protective standard in the interest of nduuiiistrari\e feasibility. I have little doubt that lie could inject such standards for any reason whatsoever, including even political luasibihiy. m In prior cases this Court has looked to sources other than the legislative history to breathe life into otherwise vague delegations of legislative power. In Arrtvnrnn Power tf- Light Co. v. SEC, 329 U. S. 90. 104 (1946), for example, this Court concluded that certain seemingly vague delegations "derive[d] much meaningful content from the purpose of the Act, its factual background and the statutory context in which they appear." Here, however, there is little or nothing in the remaining provisions of the Occupational Safety & Health Act to provide specificity to the feasibility criterion in 5 6 (b) (5). It may be true, as suggested by M. Justice Mahshali., that the Act as a whole expresses a distinct preference for safety over dollars. But, that expression of preference, as I read it, falls far short of the proposition that the Secretary must eliminate marginal or insignificant risks of material harm right down to an industry's breaking point. Nor is this a case like Lichtcr v. Cuffed b'fntes, 334 U. F. 742, 7S3 < 194$), where this Court upheld delegation of author ity to recapture "excessive profits" in light of a pre-existing administrative piactice. Here, the Secretary's approach to toxic substances like benzene could not have predated the enactment of 5 0(b)(5) itself. Moreover, there arc indica tions that the postenactment administrative practice has been less than uniform. For example, the Occupational Safety A Health Review Commission (OSHRC), the body charged with adjudicating citations issued by the Secretary under the Act, apparently dues not agree with the definition of "feasibility," advanced in this case by the Secretary. In Continental Can Co., 4 BNA OSHC 1541. 1070-1977 CCIl OSHC 21,009 (1976), the Commission reasoned: "Clearly, employers have finite resources available for use to abate health hazards. And just as clearly if they are to be made to spend without limit for abatement of this hazard their financial ability to abate other hazards, in cluding life threatening hazards, is reduced." Id., at 1547, 1976-1977 CCH OSHC, at 25. 256. Furthermore, the record in this case contains at least one indication that the Secretary himself was, at one time, quite uncertain what limits 5 0(b)(5) placed upon him. In an nouncing the proposed 1 ppm standard and discussing its eco nomic ramifications, the Secretary explained that "(wjliile the precise meaning of feasibility is not clear from the Act. it is OSHA's view that the term may include the economic ramifi cations nf requirements impure*.! by standards." App. 133s. OCCUPATIONAL SAFETY & HEALTH REPORTER This candid and tentative statement falb far short of the Secretary's present position that economic and technological considerations set the only limits on his duty to adopt the most protective standard. Finally, as noted earlier, the Secretary has failed to apply his present stringent view uniformly, re jecting in this case a lower standard for some industries on the grounds of administrative convenience. In some cases where broad delegations of power have been examined, this Court has upheld those delegations because of the delegatee's residual authority over particular subjects of regulation. In United Staten V. Curtiss,- Wright Export ('urp., 299 l\ 8. 304 (1936). this Court upheld a statute authorizing the President to prohibit the sale of arms to certain countries if he found that such e prohibition would "contribute to the reestablishment of peace[.]" This Court reasoned that, in the area of foreign affairs, Congress "must often accord to the President a degree of discretion ami freedom from statvitory restriction which would not be admissible where domestic affairs alone involved." Id... at 320. Similarly, United State* v. Mnzvrie, 419 U. S. 544 (1975), upheld a broad delegation authority to various Indian tribes to regulate the introduc- a.or, o" liquor into Indian country. According to Afrizun'e, imitat.ons on Congress" authority tci delegate legislative power are "less stringent in cases where the entity exercising the demoted authority itself possesses independent authority over the subject matter." Id., at 556-557. In the present case, however, neither the Executive Branch in general nor the Secretary in particular enjoy any independent authority over the subject matter at issue. Finally, as indicated earlier, in some cases this Court has abided by a rule of necessity, unholding broad delegations of authority where it would be "unreasonable and impracticable to compel Congress to prescribe detailed rules" regarding a particular policy or situation, ,-lwwim Power Ac Light Co. v. SEC, 329 l". F. 90. lUo (1946). Fee also Buttfxeld v, Stranahan, 192 U. F. 470. 496 (1904). But no need for such an evasive standard as "feasibility" is apparent in the present case. In drafting 6 (b)(5). Congress was facer! with a clear, if difficult, choice between balancing statistical lives ami in dustrial resources or authorizing the Secretary to elevate human life above all concerns save massive dislocation in an affected industry. That Congress recognized the difficulty of this choice is tT'ai from the previously noted remark of Sen ator Saxbe, who stated that "When v. h come to saying that an employer must- guarantee that such an employee is pro tected from any possible harm, I think it will be our of the most difficult areas we are going to have to ascertain.'' Leg. Hist. 345. That Congress chose, intentionally or unintention ally, to pass this difficult choice on to the Secretary is evident from the spectral quality of the standard it selected and is capsnlizf-d in Senator Snxbe's unfulfilled promise that "the terms that we me passing back and forth are going to have to be identified." Ibid. IV As formulated and enforced by this Court, the nondelegation doctrine serves three important functions. First, and most abstractly, it ensures to the extent consistent with orderly governmental administration that important choices of social policy are made by Congress, the branch of our government most responsive to the popular will. See Arizona v. California, 373 U. F. 546, 626 (1963) (Harlan. J.. dissenting in part); United States v. Robef, 3S9 U. S. 258. 276 (1967) ( Buen nan, J., concurring in the result). .Second, (he doctrine guarantees that, to the extent Congress finds it necessary to delegate 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON. D C 20037 sAL 0CG01c2v3 hfy CURRENT REPORT authority, it provides the recipient of that authority of with an "intelligible principle" to .guide the exercise of the delected discretion. See Havip^^A.-.Co. v. United States. '276 U. S. 394, 409 (1923): Patianitfilcfiriiny Co. v. Ryan, 293 U. S. 3SS. 430 (1935). Third, an'd-SJerivative of rhe second, the doctrine ensures that courts chwrjrfcd with rev-ewii-.g the exorcise of delegated legislative discretion will b* able to test that exer cise against ascertainable standards, bee .Ir'cmm v. C<tlijonn(i, supra, at 620 (Harlan. .1.. dissenting in part): .4 uierican Poirer if- Liyht Co. v. SH(\ 329 U. b. 90. 106 >. 194bt. I believe the legislation at issue hern fads on all three counts. The decision whether the law of diminishing returns should have auv place in the regulation of toxic substances is quintessentiaily one of legislative policy. For Congress to pass that decision on to the Secretary in the manner it did violates, in my mind. John Locke's caveat--reflected in tin* cases cited earlier in this opinion--that legislatures lire (n make Inns, not legislators-. Nor. as I think the prior discussion amply demon strates. do the provisions at issue or their legislative history provide the Secretary with any guidance that might lead luin to his somewhat tenativc conclusion that he must eliminate exposure to benzene as far as techiiolugivally and economic-ally possible. Finally. I would suggest that the standard of "feasibility" renders meaningful judicial review impossible. Wo ought not to shy away from our judicial duty t" invali date unconstitutional dr legal ions of legislative author it v solely out of concern that we should thereby reiuvigorale ihsei edited constitutional doctrines of the pre-Xi-w Deal era. If the nundelegation doctrine has fallen into the same desuetude as have substantive due process ami restrictive interpretations of the Commerce Clause, it is. as one writer has phrased it. "a case of death by association|.}" J. H. Llv. Tx-mocracy and Dis trust, a Theory of Judicial Review 133 I 1980). Indeed, a number of observers have suggested that this Court should once more take up its burden of ensuring that Congress does not unuecesssarily delegate important choices of social policy to politically unresponsive administrators.1. Other observers, as might he imagined, have disagreed.' If we are ever to rcshoulder the burden of ensuring that Congress itself make the critical policy decisions, this is surely the case in which to do it. It is difficult to imagine a more obvious example of Congress simply avoiding a choice which was both fundamental for purposes of the statute and yet politically so divisive that the necessary decision or compro mise was difficult, if not impossible, to hammer out, in the legislative forge. Far from detracting from the substantive authority of Congress, a declaration that the first sentence of G (b)(5) of the OSH A constitutes an invalid delegation to ti.e Secretary of Labor would preserve the authority of Con gress. If Congress wishes to legislate in an area which it has not previously sought to enter, it will in today's political world '.<.1 .1. p. Fly. 1 >imin t.i-a iiii.I Di.-trim, ., Tln-.ry <( Jwliri.il If.-uriv Fil-IX-i OUMlj; .1. 1) Kru Jw.'ii. Crvh ..u-l I.vuU ir...>. th- A<Jniii-rr:i* i-.-r- I'ron-zss ami Arm-nciii (lovi-rntin.iii 7S-'.U ll'n.sl; 7 J- b'"1. 9 1-jut I.f l.ilx'i;ili.-ur. I.i.-.U.-nv. I'cliry. ;m<! th<- Oi-i- <3 Ful.li-- Amhonly rxi-l m. '.'in-JUII <Iv<S!M: IVn^fir, )S.-y>ai.| ! li-,-rr-li'.n..;> Jtn-tio-, S) Yule I. . J A7.`>, 3.VJ-.W (I'C.'i . VV.-n-i -1 li t-]' in In-i'il.iV"". 'A* 'roo-ji: on I'n-l, A'liv. 3. lOT'.l, p AII i. Mil 1 1 t. W O J l`-i,L-li.-, Uu liar*., Vnmif Man J17 I IV7-I). - rs,-t- K. C. 1 >, vi-. 1 h-. ivtum.iM .1>i-tii-v A I'f--linr! >rv Inquiry -19-51 (PlUU); Slew.in Tin- IP I'oriii i( i-j'i nl Aiii*-fi'-:ili \.!niuii-ir line haw, IvS II. -irv !. Kev liv;i. mux-1i--<T i t-.ii "0 t'l l.u?.-. Ti.r IKu.-.-.ii of <he lilt- il Ailitnni-i rain'li. liar' !. Ri-v U'1'), n U"-.U 183 undoubtedly run into opposition no matter how the legislution is formulated. But that is the very essence of legislative authority under our system. It is the hard choices, and not the filling in of the blanks, which must be made by the elected representatives of the people. When fundamental policy de cisions underlying important legislation about to be enacted are to be made, die buck stops with Congress and the President insofar as he exercises his constitutional role in the legislative process. I would invalidate the first sentence of $ 6 (b)(5) of the Occupational Safety and Health Act of 1970 as it applies to any toxic substance or harmful physical agent for which h Sate level, that is a level at which "no employee will sillier material impairment of health or functional capacity even if such em ployee has regular exposure to (that hazard] for Lhe period of his working life! 1" is. according to the Secretary, unknown or otherwise ''infeasible.11 Absent further congressional action, the Secretary would then have to choose, when acting pursuant to 5 6 (b)(5). between setting a safe standard or set ting no standard at till.' Accordingly, for the reasons stated above. I concur in the judgment of the Cuurt affirming th judgment of the Court of Appeals. Mu. Justice Mah.-hall, with whom Mr. Justice Bhbs^nan, Mn, Justice White, and Mk. Justice BLACKMt/jr^joiii, dissenting. ?? In cases of statutory construction, this Court's authority is limited. If the statutory language and legislative Intent are plain, the judicial inquiry is at an end. Under our juris prudence, it is presumed that ill-considered or unwise legisla tion will be corrected through the democratic process; a court is not permitted to distort a statutes meaning in order to make it conform with the Justices' own views of sound social policy. See 7T.4 v. Hill, 437 U. S. 133 (1978). Today's decision flagrantly disregards these restrictions on judicial authority. The plurality ignores the plain meaning of tiie Occupational Safety and Health Act of 1970 in order to bring the authority of the Secretary of Labor in line with the plurality's own views of proj/er regulatory policy. The unfortunate consequence is that the Federal Government's efforts to protect American workers from cancer and other crippling diseases may be substantially impaired. The first i-eutence of ^l>tbj{5l of the Act provides: "The Secretary, in promulgating standards dealing with toxic materials or harmful- physical agents under this subvetiuu. shall set the Mandat'd which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity oven if such employee has regular exposure to the hazard dealt with by such -tamkird fur die penud of his working life." 29 U. F. CA -i 655 (l) (.3). In this case the Secretary of I.abur found, on the basis of substantial evidence, that i 1 ) exposure to benzene creates a i :sk of cancer, ehrumnsunial damage, and a variety of non- ' lias ruling wunM imt ii.v-'s' ativ effect iipon -taiiilardv gmertung toxic >ii!w-aikes or lurniful [iliy.-i.-n) for ivlih-h .i.-if*- h-wl.-i are lendl'la, upon f-xtaiu Mi-.Mar-P |irtunii!iMte<i n- 'jraljeaiil runi-en.-i's .-laiulsmN" arnFr nur <i;><hi the sh-creiarv'.-s authority to promulgate `Vtner- K'-ucy i>`n>|n>r.iry .sraiuhtrii-" uiuh-r 0 (e). 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC. WASHINGTON. DC. 20037 SAL 184 malignant hut potentially fatal blond disorders. even at the level (if l ppm; ( 21 no safe level of exposure lias Wen si>own ; (3) hent-fiLi iii the form.of saved lives would be derived from the permanent standard; (4) the number of lives that would be Saved could turn out to W cither substantial or relatively small; (n) under the present state of scientific knowledge, it is impossible to calculate even in a rough way the number of lives that would be saved, at least w itbout making assumptions that would appear aWutd to much uf tin- medical commu nity; and (6? the standmd would not materially harm the financial Condition ot the covered industries. The Court does not set aside any uf these findings. Thus, it could not be plainer that the Secretary's decision was fully in accord with Ins statutory mandate ''must adequately [to] assnref 1 . . . that no employee will surfer material impairment of health or functional canacity. . . The plurality s conclusion to the contrai-v ;5 based on i!s intei j net a lion <; 29 l.'. S. ('. > (j.">2 t S). w iii,-li defines an occu- pational safety and health standard j? one `'winch requires Conditions . . leaionably mres.-ary or appri ) >riate to jirovidc safe or health rut employment. . . ." According to the plu rality, a standard n> nut "reasonably necessary or appropriate" unless the Seereiarv is aide to .-how that it is "at lea-t more likely than not. ' at 42. that tin- risk he seeks to reg ulate is a `'significant" one. Hud. Nothing in the statute's language or legislative history, however, indicates that the "reasonably necessary or appi update" language should be given tins meaning. Indeed, both demonstrate that the plu rality's standard bears no connection with the acts nr inten tions of Congress ami is based only on tie- plurality's solicit ude for the welfare of regulated industries. And the plurality uses this standard to evaluate not the agency's decision m this case, but a strawnmn of its own creation. Unlike the plurality, I do nut piiqaart to know whether the actions taken by Congress ami Us delegates tn ensure occu pational safety represent sound or unsound regulatory policy. The critical problem in cases like the one at bar is scientific uncertainty. While science has determined that exposure to benzene at levels above 1 ppm creates a definite risk of health impairment, the magnitude of the risk cannot be quan tified at the present time. The risk at issue has hardly been shown to he insignificant; indeed, future research may reveal that the risk is in fact considerable, lint the existing evi dence may frequently be inadequate to enable the Secretary to make flic tine-hold finding of '`i-ignificance'' that the Court requires today. If so, the consequence of the plurality s ap proach would be to subject American workers to a continuing rhk of cancer ami otln-r fatal diseases, and to render (lie Fed eral Government powerless to take protective action on their behalf. Such an approach would place the burden of med ical UMcertaintv squarely oil the shoulders uf the American worker, the intended beneficiary of the Occupational Safety and Hc-.'dth Act. It is fortunate indeed that at Joa.-t a major ity of the Justice.-* reject the view that the Sccretury is pre vented from taking regulatory action when the magnitude of a ht-.dlli ri-k cannot be quantified on the basis of current technique?. See cult, at 3-4 (1'owkll., J. concurring in part and concurring in the judgment); s` e a Ho unte, at 45, and n. bo i plm ality opinion ). Because today's holding ha> no basis in the Act. and be cause the Court lias no authui Ay to impose its own regulatory policies un the Xuliuu, 1 dissent. OCCUPATIONAL SAFETY & HEALTH REPORTER I Congress enacted the Occupational Safety and Health Act as a response to what was characterized iu> "the grim history of our failure to heed the occupational health needs of our workers."' The failure of voluntary action and legis lation at the state level, see Subcommittee on Labor of the Senate Committee on Labor and Public Welfare, 92d Cong., 1st Ses.. Legislative History of the Occupational Safety and Health Act of 1970 (Comm. Print 1971) (hereinafter Legis. History) 144, had resulted in a "bleak" and "worsening"* situation in which 14,500 persons had died annually as a result of conditions in the workplace. In the four years preceding the Act's pas?flge, more Americans were killed in the work place than in tlte contemporaneous Vietnam War. S. Rep. No. 9J-12S2. !)lst Cong.. 2d bess., 2 (1970); Legis. History 142. The Act was designed as "a safety bill of rights for close to till million workers." ' Its stated purpose is "to assure so far uo possible every working man and woman in the Aatiuu safe and healthful working conditions and to pre serve our human resources." 29 C. 8. C. <551 (b). See A this C. v. ()SH 1{(`, 4d<) 1_. 8. 442. 444-445 (1977). The Act is enforced primarily through two provisions, bust, a "general duty is imposed upon employers U) furnish employment and places of employment "free from recognized hazards that are causing or are likely to cause death or-serious physical huim. . . 21) l.. be C. >Uiu4 (aj(l). Second, the Secretary of Labor is authorized to .set "occupatiuHal Sfl/cty and health standards. ' defined as standards requiring "con ditions, or the adoption or use of one or inure practices, means, operations, or processes, reasonably necessary or ap- propiirtte to piovtdc safe or healthful employment and places of employment " ill I . 8. (\ 5 652 18). The legislative history of the Act reveals Congress' particu lar concern for health hazards of "unprecedented complexity" that had resulted from chemicals whose toxic effects "arc only now being discovered." S. Hep. No. 91-1282, Hist Cong., 2d Srss., 2 (11)70); Legis. History 142. "Hecent scientific knowledge points to hitherto unsuspected rn use-aud-etfect --:aT:or--bins between occupational exposures :n:d msnv of ; >:-a I led ejir-.mie diseases--cancer, respiratory ailments, jiaug . heart, d'sense, and others." Ibid. Memliers of Oongr;uj<;k repeated references to the dangers (rosed by i ur-iiiiiaen* and to the defects ill uur knowledge of their operation and effect.' One of the primary purposes of the A<-t was to ensure regulation of these "insidious `silent' killers." This special runcerri led to the enactment of the first sen tence of 211 U. S. (.'. 5: On.; (h) (o). which, as noted above, ]it ovides: "The >eer< taiy. in promulgating standards dealing with toxic materials nr harmful physical agents undei this Mih-cetkm. shall ~vt the standard which most adequately ;i.-Mirrs to the extent feasible, on the basis of the best 1 I.i-gi'l itie,- HPf/iry of the Ooiiip.oir.nnl S.,h>tv and Health Art of 3970 i-l fFer.wni.l Pv S'lMlnr \\ ) (henan.i f 1.1-4-. :fi. Ib-p \<I ). >f 1 ,-t tong.. 2.1 8o-v., 2 (11170); Leg,, J(i-v,,Tv 3 I i"gi-, Hi.-lnry iii, 4S. tf.-p N,,. Ot-fJsJ, <|-| ->,| 2 (lU7l. I.,*!-. Hi.-lery I ,V-1 DO. l.i "is. Ili-mrj 4 la (S-n. Wiili.o.i-j : H. J{ No. IH-I.'-.U Cells.. -M 8.-> , ly (1970). I.e-i.-. Ui.-i,,jv My; Legis. H.sU.ry lDI'J (Itop. Kardi). - Iz-gis Hi-tory IttAl (8cii. Daniels). 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC. WASHINGTON. DC 20037 CURRENT REPORT 185 available evidence. that no employee will suffer material impairment uf health .; functional capacity even if such employee has r'gularjexpusure to the haza'd dealt with by such standard fbtS0.iV period of his working life." This directive is designedUrimplement three legislative pur poses. First, Congress recognized that there may be sub stances that become dangerous only upon repeated or fre quent exposure.' The Secretary was therefore required to provide protection even from substances that would cause mate rial impairment only upon exposure occurring throughout an employee's working life. Second, the requirement that the Secretary act on the basis of '`the best ovaiUdde evidence'' was intended to ensure that the standard-setting process would not be destroyed by the uncertainly of scientific views. Recog nizing that existing knowledge may be inadequate. Congress did not require the Secretary to wait until definitive informa tion could be obtained. Thus "it is nnt intended that the Secretary be paralyzed by debate surrounding diverse medical opinions.'' H. R. Rep. Xu. 01-1291. hist Cong.. 2d Sess.. 18 (1070); Leg is. History 84S. Third. Congress' special concern for the ``silent killers" was felt to justify an especially strong directive to tile Secretary in die standard-setting process. Lcgis. History 5P2 (Sen Dnniiiiickl. The authority conferred by 5 {>35 (b)(5), however, is not absolute. The subsection itself contains two primary limita tions. The requirement of '`maif-rial'' impairment was designed to prohibit the Rcretar;- from regulating substances that create a trivial hazard to arb'"ed employees.' Moreover, all standards promulgated und-r the subsection must be "fca-ibie." During tire floor debit's Congress expressed con cern tout a prior version of the bill, not clearly embodying the feasibility requirement, would require the Secretary to close down whole industries in order to eliminate risks of impairment. This standard was criticized as unrealistic/ Maoris. Hi.-frrv sna (s,ai Douiiinc W): H. Tt. N'n. 01--i*jr> 1, 2d F*->s.. 2>> (19701, Ili.-tury (>os. : St-ii /. 74, mini. Cong., * An earlier version of the bill had provided; "The Secretary, in promiila.inru' i-iaint.inP unrW this section, shall set the standard which rti'>-f aileqn.iirlv and feasibly as.-nri's, on the bn.-is of the be-t available t-vnlerire. that rvo employee vvill suffer any impairment of healih or fuiic-ncii.tl i-apm-iry, ur clmiini-!wd life e\jiev<atu-y even if such rmpl"jee lie- rrgnlai exposure to the hazard dealt with by sutu Standard for the period of hi- wmkiiia life." J.ccie. History 2(2. This >t.indard, it was feared, "could be read to require the Secretary to b m all occupation-* in which there remain-xome risk of injury, impaired heulrh, or life expectancy. In the ra.-c of all occupations, it wilt be impos sible to eliminate all risks to safety anil health. Thus, the present rriiiTi.i could, if litcrailv applied, elo.se every bu-iiie--: in the nation. In addition, in many cases, the standard which might most `udequat !y' and 'fcaaihly' a.s-orp the prolnbirion of the danger would be (hr elimination of ths oeeiipatimi it.-elf'1 l.e^is. Hi-torv 797 IStatemetil on Amendment of Stn. Dominick). In explaining th." present language. Senator Dominick stated: "\V!ia i we were Irving to do in the bill--unfortunately, we did not have the proper wording or the prni'er drafting--was to -ay that when we are deiln.e w nl, i..\ic agent. or pliy-ieai agent#. we might to take such steps as arc ha-ilil. and pncti.al n> provide an atino.-phi-re within which a per- hoiidi <>r -ifriy would nor ), nncvleil. Unfortunately, we had lan guage pn.'idir,-- ra.ii ainenc uouii! (* ,i,--urod that no one would have a hazard ...-*> (hat no one would have anv problem for (he last of his norkmp life "ft w.e* an uare.di-iii- -faiidard. S. modified, we would He approaching the problem hv Inokuie at (lie prublem and -eiting a standard or criterjofl whicli wvidd nm refill jn harm." UUory 502. The feasibility requirement was imposed as an affirmative limit on the standard-setting power. The remainder of 655 (b)(5), applicable to all safety and health standards, requires the Secretary to base his standards "upon research, demonstrations, experiments, and such other information as may be appropriate." In setting standards, the Secretary is directed to consider "the attainment of the highest degree of health and safety protection for the employee" and al&o "tin: latest available scientific data in the lit.b). the fca-ibility uf tin- standai-l.-i. an**! experience gained ii in lev this and other bcalili and safety laws." The .Act makes provision for judicial review of occupational safetv and health standards promulgated pursuant to C55 (h)(5). The reviewing court must uphold the Secretary's determinations if they are supported by "substantial evidence rn the record considered as a w hole." 29 U. S. C. 055 (f). It is to tluit evidence that I now turn. II The plurality's discussion of the record in this case is both extraordinarily arrogant and extraordinarily unfair. It is ar rogant bi-uuise the plurality presumes to make its own factual findings with respect to a variety of deputed issues relating to carcinogen regulation. See. e. y., ante, at 4ft-47, and n. (34. It should not be necessary to remind the Members ofethis Court that (hey were nut appointed to undertake independeut review of adequately supported scientific findings rtiade bv a technically expert agency/ And the plurality's discus sion is unfair because its characterization of the Secretary's report bears practically no resemblance to what the Secretary actually did in this case. Contrary to the plurality's sugges tion, tlie Secretary did not rely blindly on some draconian carcinogen "policy.'' See ant*., at 14--15, 2o. If he had, it wuuld have been sufficient for him to have observed that benzene is a carcinogen, a pro|XJsitiou that resjKJudetits do not dispute. Instead, the Secretary gathered over 51) vol umes of exhibits and testimony and offered a detailed and ewnhandeii discussion of tlie relationship between exposure to benzene at all recorded exposure levels and chromosomal damage, aplastic anemia, and leukemia. In that discussion he evaluated, ami took seriously, respondents* evidence of a cafe exposure level. See nb-o tmte. at 3 (PowKl.t, J., con curring in part and in the judgment). The hearings on the proposed standard were extensive, en compassing ]7 days from July 19 through August 10. 1977. The 95 witnesses included epidemiologists, toxologists. physi cians. political economists, industry representatives, and M dn nor. nf cour-e. -u^.u-i ili.o u i- apj.nqrri.-ift- f,*r a federal court review mg agein-v artji>M Mindly in <P ti-r in rhr aceneyV finUingd or fact ;*n<i dHi-riimi.u inns nf |mli>-y. J trier <',tiirnx to IVerr-riv 0"eftiin Park, Inc. v. 1 iJft*. Jill 1 ,-*. MCJ, 4l*i (in; i, vniirt.- iinir-l nin|,-r(.ikf ,,! '`.a'jirdi- ing mill e,ireful" jntlii-i.il inquiry mlu llu-< Tartnrr. Snell all inquiry is designed Jn I-qiurv tin- :.g. nrv In l.,ki- ;, " li.,rtt Un kJ " AVl'ppe V. Sirtra (tub. t.U K zv -CHt, 4IU tin,ro (til.,o,,i, i,milted), |jy cuii>it]i-riiig lllc |.rw).T I ,, wrighiug ll,, III in nwHui.iU,- Imniner. Ttlerv is u'sti roimi for <--|u-r-i.iKy ri*>i-ruii> judiei.d .-eni'iuv of agency dcri-imis under a rulinuali- akin m it,:,. otlVivti C.td.-d St,Urn V. Cmnt,;,, Printutl*. flic.. 104 ( . J$. 144. l.i., ii. 4 (it).Is). jee Hnrirutttm'nttil Drfrit&e Fund v. It,,. 142 C. S. )j <. 74 4.<y f. >d HS4 (1H7H. I ^ve no Im-i-, lioui-ver, tor tin- a)>|ro:irl) taken Ly (lie ]i)uralily today, w.n.h .cm.,.,i,i. ;u in-.n'lv dr nwiew uf qne.-liniis uf fact and of reg- tilin.rv p'fii.y nit Ijiliall \.| m-filiil miw fha( are l>v 110 lilrtiiu unable to jirun.-. lli. iii-vIvi-j in (lie | mill ie:,l (irva-v.-e. Such review is OiqM'i'iallv iu.i|>- l>r*,|ni.-,i< ''tin n ihe f.iein.,) i|.i,7.tini,s at i-s.ie are ones rtlioKt wlih h the Court cannot reasuiaMy M- <X[K-ctcd <u lutve c.v(ier(ise. 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS, INC. WASHINGTON. DC. 20037 SAL ceuni9243 186 OCCUPATIONAL SAFETY 8t HEALTH REPORTER mciiiluTs of tho ;.fleeted work force. "\\ were sub jected to oxiuiistivv questioning by representatives from a variety of interested groups and organizations. Throe liable pustt ions were presents! at the hearings. The first position was that the proposed 1 ppm standard was wetssary because exposure to benzene would cause material impairment of the health of workers no matter how low the expusure level. Some direct evdeme indicated that exposure to benzene had caused rhrumosumjl damage, blood disorders, ami leukemia at ur below the U) ppm level itself. More im portant. it was suggested that the recorded effects of benzene at higher levels required an i.ift 'euce that leukemia and other d's"ideis would U'sult at levels of 1 ppm and lower, espe cially jM-t tl e prolonged I'.vjiiriin.' (.vinca! in industrial set tings. Therefore, the standard should be set at the lowest feasible level, which was 1 ppm. The second position was that a 1 ppm exposure level would itself pose ail unwarranted threat to employee health and safety and that the available evidence necessitated a signifi cantly lower level. An exposure limit below 1 ppin, it was argued, would be feasible. There were suggestions that ben zene was gradually being replaced in many of the affected industries and th.it most companies were already operating at or below the 1 ppm level. The third position was that the 1971 standard should be retained. Proponents of this position suggested that evidence linking low levels of benzene exposure to leukemia was uncer tain. that the current exposure limit was sufficiently safe, and that the benefits of the proposed standard would be insufficient to justify the standard's costs. In addition, there was testi mony that the expenses required by the proposed standard would be prohibitive. The regulations announcing the permanent standard for benzene are accompanied by uu extensive statement of rea sons summarizing and evaluating the results of the hearings. The Secretary found that the evidence showed that exposure to benzene causes chromosomal damage, a variety of non- malignant blood disorders, mid leukemia. i`A. 81a). He concluded that low concentrations imjm-ed a hazard that was sufficiently grave to call for n-gulitniy action under the Act. Evidence of 'i>U ,'cmuu.v effort t. The Secretary referred to studies which Conclusively demonstrated that benzene could damage chromosomes in blood-forming cells. (App. 126a). There was te.-thnony suggesting a causal relationship between chromosomal damage and leukemia, although it could not be determined whether and to ulmt extent such damage would impair health. (App. l2l)a-13Ma 1."' Some studies had sug gested chromosomal damage at exposure levels of 10-25 ppm and lower.1' No quantitative close-response curve, showing die relation.'l; ip between exposure levels and incidence of chromosomal damage, could yet be established. I App. 132a). Tlie evidence of chromosomal damage was, in the .Secretary's view, a cause for "`serious concern." fApp. 132a). The most common effect of benzene exposure was a de crease in the levels of blood platelets and red and white blood cells. If sufficiently severe, the result could be pancytopenia or aplastic anemia, nuneancerous but potentially fata! dis eases. There was testimony that some of the nonmalignant blood disorders caused by benzene exposure coil hi progress to or represented a jneleiikemic stage which might eventually evolve into a frank leukemiu. fApp. S3a)." l" Tr 258-2.V1. 1030. 11 Tr. 14*5, 200-201. 23.S. '-Tr. 14i, 17;!--174, 3.Y2, 1227, ]P2\ T.'O'i; I-.\. 48H, p. tfifl. Considerable evidence showed an association between ben zene and Nonmalignant blood disorders at low exposure levels. Such an association had been established in one study in which the levels frequently ranged from 0 to 2,5 ppm with some concentrations above 100 ppm fApp. 87a); in another they ranged from 5 to 30 ppm fApp, SOa). Recause of the absence of adequate data, a duse-responsc curve showing the relationship between benzene exposure and blood disorders could not be constructed. There was considerable testimony, however, that such disorders had resulted from exposure to benzene at or near the current level of 10 ppm mid lower." Tim Secretary concluded that the cmrent standard did nut provide adequate protection. He observed that a "safety factor'' of 10 to 100 was generally used to discount the level at which a causal connection had been found in existing studies.11 Under tins approach, he concluded that, quite apart from any leukemia risk, the permissible cxjKtsure limit should be set at a level considerably lower than 10 ppm. Finally, there was substantial evidence that exposure to benzene caused leukemia. The Secretary concluded that the evidence established that benzene was a carcinogen. A causal relationship between benzene and leukemia was first reported in France in 1SU7, and since that time similar results had been found in a number of countries, including Italy, Tur key, Japan, Switzerland, the Soviet Union, and the United States. The latest study, undertaken by the National In stitute for Occupational Safety and Health (NIOSH) in the I970's, reported a five-fold excess over the normal incidence of leukemia among workers exposed to benzene at industrial plants in Ohio. There was testimony that this study seri ously understated the risk.'1 The Secretary reviewed certain studies suggesting that lowexposure levels of 10 ppm and more did not cause any excess incidence of leukemia. Those studies, he suggested, suffered from severe methodological defects, as their authors frankly acknowledged.'" Finally, the Secretary discussed a study suggesting a statistically significant excess in leukemia at lewis of 2 to 9 ppm. (App. S9a)." He found that, despite certain deficiencies in the study, it should be considered as consistent with other studies demonstrating an excess leuke mia iisk among employees exposed to benzene, (App. 110a). Areas of uncertainty. The Secretary examined three areas of uncertainty that had particular relevance to his decision. : ;r an. aiKV-iMj. n.,7. IU23. 2543, 2S0. 32iW; Ex. 3, p. 56. '7'.- luy 121.S, Jong, 2847. " Tr. JiX', 314, 747. 70S, 7t>G-7?0, 874 , 2445. A? rhe Secretary observed, the issue oi the exposure level in the NIOSII study wij extensively debited during :he hearings. A report from the Industrial Commission of Ohio suggested thnt concentrations generally ringed from 0 to 10 or 15 ppm. But the Secretary concluded tint evidence at the hearings showed that area exposures during the study period had sometimes substantially exceeded that level. Because of I he conflicting evidence and the absence of moni toring d.ita, he found that the excess leukemia risk observed in the NIOSH study could not be linked to any particular exposure level, '"As tn (lie c-tiidy on wliiili industry robed must heavilv, for example, the Secretary, largely repeating the author's own admission*, observed that (U a number of employee, included in the sample may not have been exposed to benzene at any time; (2) there was inadequate follow-up of numerous employees, o that persons who may have contracted leukemia were not included in the data; (3) the diagnoses wore subject to er:ouquestion, and cases of leukemia may have gone unnoticed. (4) no dc .mirution of exposure levels had been ntude; and (51 the occupational his tories of the workers were ailmitteilli itnxniiplofe. (App 1 lihi-ll la )l'Tr. J023-1024, 1227; Ex. 154. 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC. WASHINGTON. D.C. 20037 000019,^4 CURRENT REPORT First, he pointed to evidence that the latency period for benzene-induced leukemia could range from 2 to over 20 years. (App. 116a). Since lo.wejfcexposure levels lead to an increase in die latency period. itjwUuM be extremely difficult to obtain evidence showing the dose-response relationship between leu kemia anti exposure tojbwr levels of benzene. Because there has been no adequate monitoring in the past, it would be practically imjiossiblt; to determine what the exposure levels ,vere at a time sufficiently distant so that the latency period would have elapsed. The problem was compounded by the difficulty of conducting a suitable study. Because exposure levels approaching 10 ppin had been required only recently, direct evidence showing the relationship between leukemia and ex|KiSure levels between 1 and 10 ppm would be unavail able in the foreseeable future. Fecond, live Secretary ob-cr-.-rd that individuals have rlifTercnr-i'h in (heir susceptibility to leak* ruin {A[;p. ] 17a). Among thoi-' exposed to benzene wa.- n group of unknown but possibly substantial si/.*- haring carious "predisposing factors" whose iiii'iulieis were- c.'pvei.u'y vuluurabU* to lh** disease. (App. USa ; Is la). Tim p"i m.-ucii t atamho'd was designed to mini mize the effects of exposure for these susceptible individuals a-** well as for tin- relatively in:cti.-'itive (App. 18-la) and also to fan dilate early d lag no.-is and t reu tun-lit. i App. ! 18a-l l'.ki). The Secretary discussed tin eonP-nijun tfi.n a safe level of exposure to bcii/me h.t 1 been d> monstrated. From tlie testiiinniy of numerous scientists, he concluded that it had not. (App. 12-1)." lie nlso found diet although no close-response curve Could lie p'otte-l (App. 182a).''' tlie extent of the risk would decline with the exposure level. (App. ls3a).2" Ex posure at a le'H of 1 ppm would therefore be less dangerous than exposure :U one ot 10 ppm. The Feoretury found that tlie existing evidence justified the conclusion that he should not "wait for answers" while employees continued to be ex posed to benzene at hazardous levels. Finally, the Secretary responded to the ergument that the permissible exposure level should be zero or lower than 1 ppm. (App. Iboa).1' Even though many industries had already achieved the 1 ppm level, lie found that a lower level would not be feasible. I App. 187a). Costs and benefits. The Secretary offered a detailed dis cussion of the role that economic considerations should play in his determination. He observed that standards must be "feasible." both economically and technologically. In his view the permanent standard for benzene was feasible under both tests. The economic impact wmdd fall primarily on the more stable industries, such as petroi-mm refining and petro chemical production. (App. 134a). industries would be able readily to absorb the costs or to pass them on to consum ers. None of the twenty affected industries, involving 157.000 facilities and figO.OOO exposed employe*;:? (App. td7a), would be unable to bear tin* required expenditures (App. Idoa). He concluded that the compliance costs who "well within the fi nancial capability of the covered iinTu-tnes." (App. lft'to). ' tins K-sl'nniny <d Dr. .\knv, one uf tin* !.-.i.tiii^ e\)n*r(i*. was typn al: "[F.]veu our ppm . . cau-cs r,mrcr." Tr. 204 See also Tr. 30, lt-0. 75?. 32*. 363-31.4, 746-746, 2 1*20, 304, 1057, 1210. 35I-;U2. Fx 272, p 1. ,vTr. 130. 300. 414-416. IUi-417. 760-761. 7M-7?-2, '125, 1055-1056; Ex. 75. p. 2; Ex. i'-J, p. 11. **Tr. 35?. 401, 105. 1.172, 2vlll, 2542-2x43. -'Tr. 1 16-140 / 'tin- 11'-mu--al/e i \ | n i-uri' litnil -IhiM 1w zero") ('[>>- lunmiy of Dr. Akmv) So* al-v tr. 1251 >1 seq . Tr 350d rt stq :187 Aii extensive survey of the national economic impact of the standard, undertaken by a private contractor, found first-year operating costs of between 8187 and S'AK) million, recurring annual costs of $;{4 million, ami investment in engineering con trols of about S2ti(i million.11 Since respondents have not at tacked the Secretary's basic conclusions as to cost, the Secre tary's extensive discussion need not be summarized here. Finally, the Secretary discussed the benefits to be derived from the permanent standard. During the hearings, it had been argued that the Secretary should estimate the health benefits of the (imposed regulation. To do this he would be required to construct a dose-respouse curve showing, at least in a rough way, the number of lives that would be saved at each possible exposure level. Without some estimate of ben efits. it was argued, the Secretary's decisionmaking would .be defective. During the hearings an industry witness at tempted to construct such a dnv>respoj>se curve. Restricting himself to caicinozenic efforts, hr estimated that the proposed standard would save two lives every six years and suggested that this relatively minor benefit would not justify the regu lation's costs. The Secretary rejected the hypothesis that the standard would save <jnlv two lives in r.i.x years. This estimate, he concluded, was impossible to reconcile with the evidence in the riTuril. (App. Hi la).71 llrdctc: mined that, because of numer ous uncertainties in tlie existing data, it was impossible to construct a doM'-rcsponse curve by extrapolating fvoirwithose ay "The phir;i| 11 y'a rMiin.il- of x|\r ,>iik,uni uf (<c|H'ii<iiturv j*r employee, see ur.tr, :i! IP, I- hi-hly un.-lead in". Musi nf the eeslii of tin- ln*:u. lie at.in ! ird wunkl 4>r iiirnrn-iI cnrl\ mice ami wuniil thu.** protect ;u: lin.iec.T- laiii.UIr manlier uf (*mpliiviv?* in (he future: that number will be much 1 ti.pit-t tkui 11n* number i,f rniplinii-s currently cmplo'-tl, "Tim prujei-fifiit, de-igued a.i ail e\tru|ir>l.iiioti from inalgamation of {sibling stndiM, wr:< dependent on a number of ns*umpiiuna which the Sec retary cuiil.i rea-oiiablv view .1.- quesliniiable. Indeed, the witness himself slated that his estimate was based on "a lousy *et of data,1' was "slightly better than a -in*>-." Tr. 2772, ami that there was "no reul bn.-is," Tr. :.'/ li*. h*r i ik-e-re.-poli.-e i*iirve mi wlm h I tx- c.-l uii.i'e w:i wbully dcjiendrul. The witne-s' assumption* wen* seterelv tested during the hearings, fee Tr 2705 w . and the Secretary could reasonably reject them on (lie bi-b of ihe evidence in the record. For example: (t) The witness ai> |jiarotl in a--time that in [uv\ions tc-is leukemia hud I teen contracted after a lihiimi* ol i'\;ii>-im--. ilus evidence tdfurded no basis for that n- fomplion, and the duration of exposure may have been quite short for ('articular i-rnpl.ivt-fs. If the duration period was short, the witness' esti mate would have been much too low. i2) The witness assumed that eX- posun! levels in the NI05H i-tuily were around 100 ppm. The Secretary found, however, that no such a.ssnmptiun could be made, and there was evidence that PxpoMire levels had generally been between 0 and 10-15 ppm. (3) Tin* witness Resumed that the Ha^e-rcsponse curve was linear at all levels, but there was no basis fur th.it nsaumption. In the ca.-w of vinyl chloride (aunrlier vnreinoeen for which the Secretary hasprorcul- gated exposure sMnduriis), rrernt evidence suggested that the dose-re- sponse curve ri.-es -tceply at low rfo.-es and becomes fe?s steep as the levels are incre.istd. (4) Twt*itly-live percent of the workers in the NI0SH study Jiad i:ol been found, and the witness assumed that they were atill alive and wotilil not contract leukemia. Six hundred additional workers expo.-ed in that -Indy wore still alive; the witness assumed they too would not contract Ipukcmi.i. There was considerable testimony that, for these and oiher reasons, the NIOSH study significantly underestimated the risk. Tin* 'vilii<-> a.^-uims- th.il il had nut. (5) Tile* N108H study found u (ivc-h-ld ecu-- n-k from In na.-no i*\|'i*-iirc: rh- witnesj a.-.-urud that the c*\i'--s w.i- iihh Ii lower, lU-.-j'i'c the M<'6H linding and the teslimniiy that iliai fimhiiu "as a A-nificuiii nndcr.-iatcmcm of tin- ri-k. ' In light of Ihc.-c iiih i rl.01,1 llie Sim-laiy lansld conclude: that the witness' esti mate "a- un*ii|.lii.rialU\ '7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC, WASHINGTON. DC 20037 SAL 0C0C19245 188 OCCUPATIONAL SAFETY & HEALTH REPORTER data to lower exposure levels.3'* * *M7 o* *re* * generally, the Secre tary observed that. it had not been established that there was a safe level of exposure for benzene. Since there was con siderable testimony.'that the risk would decline with the exposure level (App. l(50a), the new standard would save lives. The number of lives saved "may be appreciable,1' but there was no way to make a mure precise determination.13 Tin* quotum was "on (he (T-nti-ls of scientific knowledge." i.\pp. KiUa). The Secretary concluded that, in light of the scientific uncer tainty, lie was not inquired to calculate benefits more precisely. (Apji. Hi2a-Hi4ab In any c.rnl he gave "careful considera tion' to the <|ue.-t!<sit of whether the admittedly suh>tantial costs Wen: justified in light of the hazard.-. of benzene exposure, lie concluded that those cost- were "necessary1' in Older to promote the purposes of the Act. Ill A This is not a case in 'which the Secretary found, or respond ents established, that no benefits would be derived from a permanent standard, or that the likelihood of benefits was insignificant. Nor was it shown that a quantitative estimate of benefits could be made on the basis of "the best available evidence." Instead, the Secretary concluded that benefits will result, that those benefits "may" be appreciable, but that the dose-response relationship of low levels of benzene exposure and leukemia, noumalignaut blood disorders, and chromosomal damage was impossible to determine. The question presented is whether, in the.se circumstances, the Act permits the Secretary to take regulatory action, or whether he must allow continued exposure until more definitive infor mation becomes available. As noted above, the Secretary's determinations must be upheld if supported by "substantial evidence in the record conridered as a whole." 2!) U. S. S 'inA (f). This stand ard represents a legislative judgment that regulatory action should be subject to review mure stringent- cliaii the traditional Witii.---li-Mil'vinjt lu llie iiiilnlif\ li> coiMllict a (iore-rvqSHne carry n-h-rrvU prun.irily to iLs iinp<i."il>iliiy of eurrei.itmg llin iii'-iiPuce of !r>l<w'iin;i, blue*! tli-ortliT-. .on! i. iifiillin.->11 uI d.ilil.igi; w.llt (he levels and duruiiuu of i\|iii'iiie in [m-I .-Jiiilies. Tim* Dr. lk-nn.iii Kraybill of the X;ioonul C.uiirr lii'imiU' n-nlivil, ". . . [W]e like to <*.itiin:tte rik factors. This hns been done, as many of yon recall, with vinyl chloride several ye.us ago. . . . [T]o estimate the risk factors on [thebn.-is nf] experimental d.itn, this presupposes you have good lexicity data. When l say toxieitv data, I mean good dosere'ponse data on vinyl chloride, which indeed we did have that. But w ith beuxenc, it appeared that we didn't have chu situation, so therefore, no.-t nf us gave up. . . With benzene, we sort of struck out." Tr. 7tiO--761. Ih-c.-tn-v of llic cnomiiai- min-rtaini ic- m level- and iloration of exjwure ill prtnr rllidn--. anv as.-utn; a im i.- wnnhl lun--arily tie arbitrary. The jiussiMf ranee ii| a--nlii|''imi' u\*.- ,-i. jy.ii that the nltiin.ile conclusion would In- entirely uniiilniiti.ii im-. Si- Tr dot), 415, l(l55-IU3l> ;l At on*' | mint the ?cit'" ;,yy xli.l imln a tv th *l appri-c lable benefits were 'likely" to result. The Court of Appeal- held that this conclusion was unsupported by sub-tantial evidence. The ''rrevarv's suggestion, how ever, was made in th- eontexl cf a h-ncthv <]is*'i>.-in|j in'ewhsi to show tlial appreciable lien-fit- ' iii .v" be prcilieii*'! but that their likelihood could not be quantified. The sii"$*.tioii should not be taken ns a definitive statement that, appreciable benefits were mure probable Ilian nut. Fur rc.iMiiis stated Aii'/vi. iln-fe i- nurhiui' in rin Act. to prohibit the Secretary frum acting wh-u In- i~ unable to cuinhiile that appreciable belielit.i al'e tUOfe probable than nul. arbitrary ami capricious standard for informal rulemaking Wu have observed that the arbitrary and capricious staudar itself contemplates a searching "inquiry into the facts" in cutler to determine "whether the decision was based oil a consideration of the relevant /actors ami whether there has been a clear error of judgment." Citizen.* to Preserve Overton Park v. Vulfje, 401 tr. S. 402. 410 { 10711. Careful perform ance of this task is cs|a-iially important when Congress hay imposed the comparatively more rigorous "substantial evi dence" requirement. As we have emphasized, however, judi cial review under the substantial evidence test is ultimately deferential. See. e. g.. Riclmrdson v. Perales, 402 L". S. 401 ( 1071); Consult) v. Federal Maritime Cumni'n. 38.4 T'. S. 007. b18-021 (1900), Tim agency's decision is eutitle* 1 to the traditional presumption nf validity, and the court is not au thorized to substitute its judgment for that uf the Secretary. If tile Secretary has considered the decisional factor? and acted in conformance with the stutut**-, his ultimate decision must l>e given a large measure of respect. Id., at 021. The plurality is insensitive to three factors which, m my view, make judicial review of occupational safety and health standards under the substantial evidence test particularly dif ficult. First, the issues often reach a high level of technical complexity. To such circumstances the courts are required to immerse themselves in matters to which they art; unaccus tomed by training or experience. Second, the factual issues with which the Secretary must deed are frequently not sub ject to any definitive resolution. Often "the factual finger points, it lives not conclude." Sacietg oj Plastics Indus., Inc. v. OS/M, 509 F. 2d 1401, 1408 (UA2) (Mr. Justice Clark), cert, denied. 421 L~. S. !)P2 (1975). Causal connections nr theoretical extrapolations may be uncertain. Third, whe. the question involves determination of the acceptable level of risk, the ultimate decision must necessarily be based on considerations <>f policy as well as empirically verifiable facts. Factual determinations can at most define the risk in some Statistical way; tin* judgment whether (bat risk is tolerable cannot be bused solely on a resolution of the facts. The decision to take action in conditions of uncertainty bears little resemblance to the sort of empirically verifiable factual conclusions to which the substantial evidence test is normally applied. Such decisions were not intended to be unreviewablf; they too must fie scrutinized to ensure that the Secretary has acted reasonably and within the boundaries set by Congress, lint a reviewing court must be mindful of the limited nature of its role. See Vermont Yankee Xuclear Fyircr Carp. v. XRUC, 445 U. S. 519 (1978). It must recognize that the ultimate decision cannot be based solely on determinations of fact, and that those factual conclusions that have been reached are ones which the courts are illequipped to resolve on their own. Under this standard of review, the decision to reduce the permissible exposure level to I ppm was well within the Sec retary's authority. The Court of Appeals upheld the Secre tary's conclusions that benzene causes leukemia, blood dis orders. and chromosomal damage even at low levels, that an exposure level of 10 ppm is more dangerous than one of 1 ppm. and that benefits will result from the proposed stand ard. It- did not sot aside his finding that the number of lives (hat would be saved waa not subject to quantification. Nor did it question his conclusion that the reduction w "feasible.11 In these circumstance?:. the Secretary's decision was reason able and in full conformance with the statutory language 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC. WASHINGTON. 0 C. 20037 S*L CCCCi^A.o jjjill'llEi~>< i i i5L&. ,.u V CURRENT REPORT 189 requiring that he 'Srt the xtandard which mnj>l a.leqiintely assures, to tli!' *'\fent feasible. on the basis of the host avail able I'vi'lnirc. that no employe- will suffer material impair ment nf health or functional capacity even if such employee lias regular ex|Kixiite to the hazard dealt with by such stand ard for the period of hi* working life." 21) U. S. C. 5 boo (b) (o). On this m-oi d. tin- Secretary could conclude that regu lar exposure above llie 1 ppm level Wulild pose a definite risk resulting in material impairment to some indeterminate but possibly substantial number of employees. Studies revealed hundreds of deaths attributable to benzene exposure. Expert after expert testified Ibat no safe level of exposure had been shown and that the extent o the risk declined with the ex posure level. There was some direct evidence of incidence of leukemia, nunnuihgnunt blood disorders, ami chromosomal damage at exposure levels of 10 ppm anil below. Moreover, nuuieruu* experts testified that existing evidence required an iniervner* dial an exposure level above 1 ppm was hazardous. \\ have stated that ''well-reasoned expert testimony--based on what is know n and utieuntradicted by empirical evijence-- may in and of itself be `.substantial evidence'when first-hand evidence on the question ... is unavailable." Fl'C v. Florida Power (t Light (Vi., -HM t\ S. 4.>3. -tti-1--4G."> (Itl72). Nothing in the Act purports to prevent the Secretary from acting when definitive information as to the quantity of a standard's benefits is unavailable.''''1 Where, as here, the deficiency in ki:oa!-,'lye iikites to the extent of the heuefit- rather than their e.\isteiicii 1 see no reason to hold that the Secretary lias exceeded liis statutory author.fy. B The plurality avoids this cmii-luaiwi through reasoning that may charitably he dexcnlicd as obscure. According to the phu.dity, the definition of occupational safety and health Stundanls as those "reasonably necessary or appropriate to ju-siite safe or healthful working conditions" requites the becietary to show that it is "mine likely than not" that the risk In seek* to regulate is a "significant'' one. Ante, at 42. The plurality does not show how this requirement can plausibly ho derived fiom the "uuisonablv necessary or ap propriate" clause. Indeed, tin- pluiality's reasoning is refuted by the Act's language, sp < ture. and legislative history, and it is foreclosed by every applicable guide to statutory con struction. In short, the plurality's standard is a fabrication bearing no connection with the acts or intentions of Congress. At the outset. it is iuijiortaiit to observe that "reasonably necessary nr appropriate" clauses are routinely inserted in regulatory legislation, and in the past such clauses have uni Ihc i' mil In -.<r tk.-i! ilir Secretary i- prulnl'i'ol fruai c`\;:iTitningf r'l i' *' ' '"'I' ami U-tiifn. in (In' |iit*ii-.- uf .-I'ltms prmrilio among I; n.ir.t.ico .-`I'/'taiu i-, nr lh.it -1 i-iti.if i<- mii-c|< r:,hull <if rust.- aad bene fit' i' 11..! In hi- .ilUninli.l IH Illr. -t.uid.tld--el f mg |ui)irss, KlUifts 10 1 r' 1 - 'ia! I d'liti- -i ri t;i.-(11. nf n-.i.'iiii' jri'in lafiv, muv help 1,1 ; "r-'iiU- H.rc.i m. .1 . i,ii-|.I.'tv,t ii.i, Ilf i!iei-iiiii.,l f.trtor- and facilitate n;da I.! u\a .v, s./t.,,j_>; p. g. 51 ,q .->T I-.'.7 4 (i')75). i !i*- .''an I in uiilii af 1 In 1 In- In- .u n milled iii 1 hi., ill in ,ai.-r - amt livn- cilii in 1 In- ;n-f -a-.- -i:; IP.i. u,.-. -,4. r> t IJ7--j4] {lt7.s) (lead); 4 :F"i ifie.-7;;:,ir. .';.">-27.!7'i h'iTs) (roiion ilu-i). ____ It i.l no* !lirr".in' in 11 u- iir<--< 1 I e.t-e (11 ,-av whether llie Secretary mu.if -Toi v- a rc.i-oit.il.li- elation livtuvvii iu-i- ami beiiclii.s. Di.-mimt- jcg for tli* t-cicnlilie lino 1'amiy, ihc Serielary i,x|)rre.'lv--.uni f.non- al'ly--luiimi such .1 idnimii livic. formly been interpreted as genera] provisos that regulatory actions must bear a rra.-njiihble relation tu those statutory purposes set forth in the statute's substantive provisions. See. e. fj., tCC X. .\dtional Citizen* (hj/nmiUte fur firoadI'wfmi/, 43G l.. 8. 77o, /!l(e-/tt; llP/8); A/uitrniny v. Family l*iu*h* l4ii*a*ttons Ft finer, /nr.. 411 l'. S. 3oli, 3t>0 11073); Thorpe v. Housing Authority of tht City uf Durham. 3P3 1_". S. 208. 2S0-2S1 (ItiptJ). The C0ijjt has never--until today--inter preted a "reasonably necessary or a.pp;\ior:ate'' clause as hav ing a substantive content that supersedes a specific congres sional directive embodied in a provision that is focused more particularly on an agency's authority. This principle, of course. rt:fl**ets the common understanding that the deter mination of whether regulations are "'reasonably necessary" may be made only by reference to the legislative judgment reflected in the statute; it must not l*e based on a court's own, inevitably subjective view uf what steps should be taken to promote perceived statutory goals. The plurality suggests that under the "reasonably neces sary" clause, a workplace is not "unsafe" unless the Secretary is able to convince a reviewing court that u "significant" risk is at issue. Ante, at 31. That approach is particularly em barrassing in this case, for it is contradicted by the plain lan guage oF tile Act. The plurality's interpretation renders utterly superfluous the first sentence of 5 Goa (hlffi). which, as noted above, requires the Secretary to set the standard "which most adequately assures . . . that no employee will suffer material impairment of health." Indeed, the plural ity's interpretation reads that sentence out of the Act. By so doing, the plurality makes the test for standards regulating toxic substances and harmful physical agents substantially identical to the test for standards generally--plainly the op posite of what Congress intended. And it is an odd canon of construction that would insert in a vague and general defini tional clause a threshold requirement that overcomes the specific language placed in a standard-setting provision. The most elementary principles of statutory construction demon strate that precisely the opposite interpretation is appro priate. See, e. y., FPC x. Teraeu, /ne., 417 L\ S. 381). 3114--3115 (1074); Clark v. Ctherstm Finunz-Kurji332 U. S. 4S0. 4884S0 (1047). In short. Congress could have provided that the Seeietarv may not take regulatory action until the existing scientific evidence prove.* the risk at issue to bn "signifi cant."'7 but it chose not to do so. It. i- Useful In ujnip.itv tin* Art willi oilier regulatory statutes in which Coiigri-'> has ii ii'iinxl a .-)* iiig nf a relal ioii.-liip tn-l'vi-cn iu-1.* Alul benefits nf of :m ' Mini i.-i-ii.ibie ri-k." in mimic statutes Congress has p\|ire-.-lv r*X)iiii'ial i-i-i -U tic-lu .in.il> -i- or a ili iiion-tration of some re.v sojlabli* rel.ilion Ih Ux-.-i) rest- amt i/ciu-fiU. See 33 V. 8. C. TO 1 (a) (Flood Control Al l of hiaii); 42 t: S. C. 7-')4.A (et (2| (HI (Ck-.ni Air Aetl: !t-', l'. 8, C. 5 1314 |M (4 M H) ((.'Iran Water Ait). In Others Congiesx liaa impu-iit 1 n n iii>ie|H-mieiil r<-< piticnit-iit -: that administrative iiilioii ! "tea'ililc" alat jn-litieil Kv a linlaining of cost; amt lructits, e. </.. 43 l . S. C. tj fi!47 |b) (<hti*'r Cmitinrnlal Shelf Laml Act.); 4'J If. S. C. (a)(4l|i)| (Fnergv 1'oln-v and ('nii-cri a lion Act). This apiim.irli iIrnioii'irale- a |rgi-|a11ve aivaifiit'.' of the iliAVrenre l>`tweeii a fi-.i-ilnlir \- coiisi r.ont .aid a eou-i r.iint b.iwxl on weighing cost - aii'i hen- eiils. cvt jiji. 32-33, ,i,/<u In slid otliris Cougrcse has an! ImriZcO rcgnl.ition of ' unrea-uiialile risk," a t(`rut wlneli lias t/een reat by -otlie roiiiis tu rri|inn- a lial.aiK ing id lo-t' and Set*, e, y.. Ayuu Slute ".V Dm- rt'SC. aiiu K. 2d Nil (C!.\5 I97.S) (colistruing 15 l\ S. C. iO-'X (i I f'-'MA) | ('(iitsiinii r Product Safety Act i): t-'nrr.-Ur v, ('t`><\ 1x2 1`. S. \|>|>. 1). A'. I.w, jolt F. -d 774 (1377) (coiotniing 15 l1. S C S 12(*1 (at JCluld Protiiti`*n and Toy Safety Aclj), 7-1Q-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC. WASHINGTON. OC 20037 SL QCCni <9247 L, 190 OCCUPATIONAL SAFETY & HEALTH REPORTER Tin* plurality's interpretation of the "reasonably necessary or appropriate" clause is ulso conclusively refuted by the leg-. Native history. While the sluinkml-setting provision that he plurality ignores received extensive legislative attention, file definitional clause received mom at all. An earlier version of ihe Act, see u. S. supra, did ;:ut embody a clear feasibility constraint and was not restricted to toxic substances or to "material'1 impairments. The "reasonably necessary Of ap* piopriate ' clause was contained m this prior version of the bill, as it was fit ail relevant times. In debating this ver sion. Members of Congress repeatedly expressed concern that it would require a risk-free uni vet se. See. e. <j., ante, at 30-37. The definitional clause was not mentioned at ail, an omis sion that would be mcumoreliensible if Congress intended by that clause to requite the Secretary to quantify the risk lie sought to regulate in order to demonstrate that it. was ``significant.'' The <n11v portions of the legislative historv on which the plurality rel'es. see ante, at 30-38. have nothing to do with the "reasonably necessary or appropriate" clause from which the "threshold finding" requirement is derived. Those por tions consisted of criticisms directed toward the earlier ver sion of the statute u'lnrh alrend1/ contained the definitional clause. These criticisms, in turn, were met by subsequent amendments that limited application of the strict "no em ployee will s"tfer " clause lo toxic substances, inserted mi ex plicit feasibility constraint, and modified the word "impair ment" bv the adieclive ''material." It is disingenuous at best for the plurality to s"gge.st that isolated statements m the legislative history, expressing concerns that were met by subsequent amendments not requiring any '`threshold'' find ing. can iustity reading such a requirement into a `'reasonably necessary" clause that was in the Act all along.-* The plurality's various structural arguments are also un convincing. The fact that a finding of ``grave danger" is re quired for temporary standards, s-'e ante, at "ifi-SO. n. 45. hardly implies that the Secretary mu-t show for permanent standards that it is more probable than nut that the substance to be regulated poses a "significant" t b.k. Xor is the reference to "toxic substances.'1 ante, at 33. in any way informative. Ami the priority-setting provision. ut**, 83-34, cannot plausi -'T!h- iiInnltM .tli relic- mi its |T<e[i1 ion that if the "reasonably invoMirv" cl.-n-e vver- w-l ^i\cn lliv iiii-.uiing it ascribes to it, then: wmiM U* no eui.lancc f..r 'st.iiKlards utlivr than ttio.-e d.-.ilii- with toxic nritrn.hs ami iiannfrl |iliv>ic.if j"riils." AitCe. at 2O-`>0. l>. 45. For two ri-.i-.nis tins argument i- without tone Kirs', even if tile reasonably lirce.-s.irv clait-r- doe- have iiitlviic-mhnt vonleiit, anil oven if that, con tent i-. a- the plunlii' deM-nh.-s it, ii canoot under any fainninded Trail ir;; sui>, r..'-de flu- i-\|uess language of lio5(b)(-5) for toxic sub stances and h rimful j.hvs-i< ,d .men'-. Pi i-i.nd, I.oli d :ih-. i*. an e.irh-T \cr-ioii of tlie bill applied the "no Cllijil'ivi-e will snlfer" l.ili^oa^e '> all -abstain-s. At tliat (itm*, t be re teas no ''gap,'' and :uTordmi>ly it tunhi not !<*- argued that the "reason* ui.ly rii-cis-siry or appiopri I'e" clause li.ul the content die plurality aonl.es to it. In this tiidil. the plumlit i 8 rviistniing must lie that when Cniiyress aini-iulnl die bill to apph- the Uriel ij h.v> (h) (o) requirements otilv to touc Mib-t.Hires-, die detinid.ui.d il.-ui-e gained all imle|icudcnt Iliealiing that in turn ei'Ul|irehi-ud'ii all standards. Blit surely this argu ment turns C'ii';r-viij:i:il pnrpo-o- on their Ivac!. ft reasons that when C i|r"re-s singled out tO'u -uh-lances for -ii*--::ci regiil.ilcm, it .-mudtafie- tui-lv Teal1 i more h-ir-ml .................... hie on-e-.-.iry'') lest for standards gciiel.dly, and that nnre that inre b-(inTjt ti~t U:i- :q.plicat,ie. it .-oine- ho-.v --.I|.er-e<!;ti rl'c -rricr r;-i|iiir-iiTli's for ruiic -iih-t.uK-f^.. That rea- -tiiiiiig i- boll I illogical aid einular. Nor i- there anv basis for die plurdi'y's siitr^estioii, -ee uefe. US, ti. 54. that 'he original bill's aj i.le ad'Ui to all -I ai uli r.ls war 'Vu'innv inadvertent." bly be read U> condition the Secretary's standard-setting an thority on an ability to meet the Court's ``threshold" requirement. The plurality ignores applicable canons of construction, apparently because it finds their existence inconvenient. But as we stated quite recently, the inquiry into statutory pur poses should be "informed by an awareness that the regu lation is entitled to deference unless it can be said not to be a reasoned and supjjortable interpretation of the Act." Whirl/tool Carp. v. Marshall,----- U. S.------- .------ (1980). Can it honestly be said that the Secretary's interpretation of the Act is "unreasoned" or "unsupjortabIe"? And as we stated in the same case, "safety legislation is to be liberally construed to effectuate the congressional purpose." Id., at ----- . The plurality's disregard of these principles gives credence to the frequently voiced criticism that they are honored only when the Court finds itself in sufjstantive agreement with the agency action at issue. In short, today's decision represents a usurpation of deci sionmaking authority that lias been exercised by and properly belongs with Congress ami its authors***! representatives. The plurality's construction has no support in the statute's language, structure, or legislative history. The threshold find ing that the plurality requires is the plurality's own invention. It hears no relationship to the acts or intentions of Congress, and it can be understood only as reflecting the personal views of the plurality as to the proper allocation of resources for safety in the American workplace. C The plurality Is obviously more interested in the conse quences of its decision than in discerning the intention of Congress. But since the language ami legislative history of the Act are plain, there is no tired for conjecture about the effects of today's decision. "It is not for us to speculate, much less act. on whether Congress would have altered its stance had the specific events of this case been anticipated." TVA v. Mill, 437 U. S.. at 18-5. I do not pretend to know whether the test the plurality erects today is. as a matter of ]>ohcy. preferable to that created by Congress ami its dele gates: the area is too fraught with scientific uncertainty, sod too dependent on considerations of jxjlicy, for a court to "be able to determine whether it is desirable to require identi fication of a "significant"' "risk before allowing an administra tive agency to take regulatory action. But in l;ght of the tenor of the plurality opinion, it is necessary to |>oint out that the question is not one-sided, and that Congress' decision to authorize the Secretary to promulgate the regulation at issue here was h reasonable one. In this case the Secretary found that exposure to ben/enc* at- levels above 1 ppm posed a definite albeit unquantifiable risk of chromosomal damage, uunmaltguant blood disorders, and leukemia. The existing evidence was sufficient to justify the conclusion that such a risk uas presented, but it did not permit even tough quantification of that risk. Discount ng for the various scientific uncertainties, the Secretary gave "careful consideration to the question of whether the[] sub stantial costs" of the standard "are justified in light of the hazards of exposure to benzene." and concluded that "these costs are necessary in order to effectuate the statutory p pose . . . and to adequately protect employees from i hazards of exposure to benzene." App. 163a. In these circumstances it seems clear that the Secretary found a risk that is "significant" in the sense that the word 7-20-80 Published by THE BUREAU OF NATIONAL AFFAIRS, INC. WASHINGTON. DC. 20037 n-,nlc^ cuArent report is normally used. There was some direct evidence of chro mosomal damage, nomualigiiant blood disoixlers, and leukemia at exposures at or near 10 ppm and below. In addition, ex pert after expert testified that the recorded effects of benzene exposure at higher levels jusbfied an inference that an ex posure level above I ppm was dangerous. The plurality's extraordinarily searching scrutiny of this factual record re veals no basis for a conclusion that quantification is. on the basis of "the best available evidence.'' possible at the present time. Tf the Secretary decided to wait until definitive infor mation was available, American workers would be subjected for the indefinite future to a possibly substantial risk of ben zene-induced leukemia and other illnesses. It is unsurpris ing. at least to me. that he concluded that the statute author ized him to take regulatory action now. Under these circumstances, the plurality's requirement of identification of a `'significant'' risk will have one of two con sequences. Tf the plurality means to require the Secretary realistically to "quantify" the risk in order to sul'sfy a court that it is "significant." the record shows that the plurality means to require him to do the impossible. But regulatory inaction lias very significant costs of its own. The adoption of such a test would subjec t American workers to a continuing risk of emu'er and oilier serious diseases; it would disable the Secretary from regulating a wide variety of carcinogens for which quantification simply cannot be undertaken at the present time. There are encouraging -tges that today's decision does not extend that far.'-"' My Brother P<>wm-l concludes that the Secretary is not prevented from taking regulatory action "when reasonable quantification cannot be accomplished by any known methods.' See nntc, at 4. The plurality also indicates that it would tint prohibit the Secretary from promulgating safety standards when quantification of the b min- is i11ipn'-sil'In. See i/',>c. at 4'i-ld. .n:d n. 03. Tin: Omit might thus allow the Secretary tr> idtr-mpt to make a. vise rough qnaiilil'.cata m of the ri-k iuipo-ed by a caremogrmr suhshnHc. and give considerable deference to his find ing 'bat the risk was signifi'-ant. If so. the Court would per mit the Six n-tary to pi on nilgai i- ] ireeis.dy the same regulation involved in this case i; he had not relied on a carcinogen - T>- pltrr.dtfv -ii2gi-s(< that if i- (nr Mir agpnry "to determine, in the fir-i : j-T.m.r-. wtisi ir iim.-i.l.-rs r< lx- a -iguifi'-aiit' risk," and that the agiT . *'i- free in ti-i oin-.-n utu n a-'imiptiou.-t in interpreting tha .in In. . . A>'lr. fli 44-4.Y Moreover, niv Brother PmvLXX. would not n-ii.irr "'pirni I ilii-alien of ri-k ill every <:i.-e." Aidr. :it 3 fl'oWUM., .1., nuie'irriiig in par* and c-oiintrrnig in ihr judgment). .As I read liis opinion. Mn. JesTtrs; p<w kll would have jieriiui led the Secretary to prminilgale the standard at. issue here if tin* .`u-ervlary had provkU-d a inure esrefiillv rn:i.-ontii i-xplidinliuii of hi.- ronrludali that the risk at i.--in- jii-titied tin* a.limit, die .-ignifi.-uu ru-i- of tlie Ix-nzene standard. Mn. -Icsia.i. 1'mu.u, il-.< -u::s><-i- I ini I .-urli a rom-l'i-iou would be miI>jei-r I.. ri!.ai\> ly tlrfip-iil i.i) review. Atr. at 7 II. 5. In 11n- re-peel, tin- (lith-n-Ti.-es ImIui-.ii iitv approai'lt and that of Mn. .Hsrur Pouil.i. in.iv he .uinp.iranv.lv u.irrme. \\V are agreed on two pr.ip.v-il tun.- 11 i.i I I r.g.rii as critieal [i> a Cairmiiatnt jMCTprelatioii of 1"e Ail; (11 iIn- S.iT.l.rv niiv regulali- ri.-k.- ihn! are not Mibjcet te .j'l.iii!ifraiuni un tin- uf dir ''li.-l .avail..I'le evidenre": ;mJ (J) :!k- ?. i-rela r\'.- judane-nt dial a paili.nl,.r Ii.mIiIi ri.-k merits recn- (.ii.ay . > r r j 111 I- -uliji-.-i to l..... i -1 iu.li.-.-i] rutinv. ll i neoiirairin^ that C lci.-l live M.ii,I., r.- .a ih-- (.V-irt aceept these ha.-.c propu-itiuus. Km r.-.-uns i<-<i ie d..- i<-nr. iimv-v.-r. [ <li.- eri''e uitli my Brother I'.jV'i.l I..- Hi-.i a. t I. . * it :. | >| .iiviu : ..< i<> l...|.| ui (I.i- ease licit the A.a, i |nin -: die r-nict.iry tu -hra a re i.-unablu rel.it lomhip U*-twuvji CO-1- and )vn.-hts. 191 "policy.' hut. under'taken a revi-w of (he evidence and die expei t testimony and cmndudod. on (he ha si* <jf i-.mvereaiivc assumptions that (he risk addies.-ed is n significant one. Any other interpretation of the plurality's Approach would alh'w a com t to dbpiie e the aget.cy's judgment w ith it.- own .subjective eoriri idion of "significance," a duty to be per formed u itlione sta;utoi v gnrdunre. lilt* eoiisrnuen.Ts (tf thi- secor d approach would hardly be d .sAs t r On.-, linked, it differs fioin my own prmcipnllv in its !i-e.s,-"!. ;)t of the basis for the Secretary's decision in this case. It is ohjccMomib'c. however, for three reason';. First. t:ii' requitcuienl of identification of a "significant" risk sim ply has no relationship to the statute that die Court today purports to construe. Second, if the ''threshold finding'' re quirement means only that die .Secretary must find "that there is a need fin -urli a slandanl." ante, at 32-33. n. 48. the requirement was plainly satisfied by the Secretary's express statement d'ltl. the standard s co-ts "are neeessarv in order to effectuate the statutory purpo.-oi . . . and to adequately pro tect employees from (he hazards of exposure to hen/.etH*." App. 103. Third, tlie record an.ply dcmoo-traler. that in light of existing scientific knowledge, no purpose would he .served by ruuiiiriug (he chcrHury to take steps to quantity the (isk of exposure to bciiXei e at low levels. Auv such < l ll a 1111 fi co t iu; i would be ha.-cd nut on ?. lenlific "knowledge'1 as that term is normally understood but on consideration!] of pnbey. tmr carcinogens like benzene, tin- assumptions on which do--respi.ii-e curve must be based :ue necessarily arbitrary. To require :i quaniitatm: showing uf a 'signifi cant" ri.-k. tlieiefure. would either paialy/e the Secretary into inaction or force him to deceive the public by acting on tilt- basis of assumptions that must bp considered too .specu lative to support any realistic a-si'x-iiici.L of the relevant risk. See McGarily, Substantive and Procedural Discretion in Ad ministrative Resolution of Science Policy (Jueations: Regulat ing Carcinogens in ERA and OSHA. I7 Geo. L. J. 723, 800 fl'.lTff). U is enrouraging that the Court appears willing not to require quantification when it is not fairly possible. See anfr. at 45-40, and n. 03. Though it is difficult to see how a future Congress could be any more explicit on the matter than was the Congress that passed the Act in 1070. it is irri5KxtHMt to remember that today's decision is subject tu legislative reversal. Congress may continue to believe that the Secretary should not lie pre vented frum protecting American workers from cancer and other fatal diseases until scientific evidence hus progressed to ;i (Kjint where he can convince a federal court that the risk is "significant.'1 Today's decision is objectionable not be cause it is final, but because it places the burden of legis lative inertia on the beneficiaries of the safety and health legislation in question in this case. By allocating the burden iu this fashion, the Court requires the American worker to return to the political arena and to win n victory that he won once before in 1070. [ am unable to discern any justi fication fur that result. D Since the plurality's construction of the "reasonably neces sary or appropriate" clause is unsuppoi table. I turn to a brief chscu.-siun of the other arguments that respondents oiler in support of the judgment below. First, respondents characterize the Act ns a pragmatic Statute d"-igncd to balance the benefits uf a safety ami health regulation against its costs. Respondents obseive tnat tin* statute 'peaks in terms of relative protection by providing 7-10-80 Published by the BUREAU OP NATIONAL AFFAIRS. INC., WASHINGTON. DC 20037 SAL 00001*3249 192 t!ia` swl'cty mud be ;usuied "to fur as possible," liU U- S. C. 5 Uol (b), and by stating that the "iiu material impairment" requirement is to be imjioscd only "to the extent feasible."3'* Ilesj'oink'iiU content! that the term feasibility should be read to 1`L-tjuiie con.-ideiution of the economic burden of a stami- aol. not men-Iy its technological iH-hievability. I do net u/1'?<-f st;iikI the S'-crcUny to disagree. But respondents pre- sent no argument that the expenditure required by the ben zene standard i- not feasible in t!i:it respect. The Secretary concluded on the basis of .substantial evidence that tin; trusts of tiie standard would be readiiv absorbed by the 20 affected industries. One need not define the feasibility requirement with precision in order to conclude that the benzene standard is "feasible" in the sense that it will not materially harm the financial condition of the regulated industries. Respondents suggest that the feasibility requirement should be undeidootl not merely to refer tu a standard's expense, but also to mandate a finding that the benefits of ail occupa tional safety ami health standard bear a reasonable relation to its costs. I believe that the statute's language, structure, and legislative history foreclose respondents' position, U\ its ordinary meaning an activity is "feasible" if it is capable of achievement, not it its benefits outweigh its costs. Sec Web ster's Third New I uteri oil iinuil Dictionary S->1 (1976). More over. respondents' interpretation would render 5 ho.'i (b)(-M infernally inconsistent by reading into the term "feasible" a requirement, irreconcilable with ilie express language author izing the Secretary to set standards assuring that "no em ployee will suffer material impairment. . . Respondents' podlimi would render that, language merely hortatory. As noted above, no c<t-benefit. nualy-is is referred to at any point iii the statute or its legislative history, itn omission wliieh cannot h* deemed inadvertent in light of the explicit, cost-benefit requirements inserted into other regulatory legis lation.'*1 Finally. die legislative history of the feasibility re- quitenient. see n. $. supra, demonstrates that Congress' sole concern was that standards he economically and technolog ically achievable, The legislative intent was to prevent the Secretary from materially harming the financial condition of J" Fni'ling ob-emin in I In- wont "fca.-ilile," my brother HkHniji TjjT lln- im >it-ict< e.e inn dm 1 rme, wliii-h M is !.<.-( il.-nl to invalidate art Act of t'l.ncri" III ScY < htrr 1`o.illnl Culp. V. L'uilni Stall's, 205 lb S. I'Ti. While ;nv Mrnitii r UkhmjI i-i eloquently argue- that there rnii.ii.ii- a ;i!.i-- f..r -n*'!i .1 Ji I nnr in our jnn-punlnu-c, I ytn frankly puzded a- (11 M iiv Tin- 1--nr i- llmil"!n l(i tie (if any relevance here. The Iinnilelee.it 11 >ti ilneiri.'ie i- de-i^aeil In a.-'iire that the luo-t fundamental cltri-iiiii- will he in .ite by t'nnirr'--.-. thy d'- o-t representatives of the liei'ple. r.i'iief ifi.m In' ndinuu-iratiH-. Some minimal definilcni'as is lliereinre r<-<pliff-rl in order for Cwgreys to del"gat its authority tn admun.-t ralive :eivit< w - . Coinrri'.- h. Ix-eti -uilwmil |y detinl'e lo re. The word "lYa.-ilile" Inis a fca-Mi.iblv pi tin tnvatiuii!. aiwl il> inlerprela 1 inn call tie iiiforriicd by other crnileM- in which ('i>in:li -- ti.is n.-iil it. See n. 27, sujiitl. Since the term (- |>i;nv\I in the .'.lira- -i-iilenee with t)w "tin employee Will suffer'' lari-zu.dtc, il i- vhar ili.it- "teiMble" means te< liliolegii'.illv and fCO- ueitiH illv hi- v.ihle. t Intel | (,e Act, (lie S vret a rv is afforded roil.-id- crablv in..re gni. I.c lev iii.01 no- ether aiiiiiini-l rulers aefinx under different relt'il.itoiy -'.fillies In -V...T1, Cetiiiie-.- hi- Iliads "the .nitiinl policy h-vlsien-'' in t hi - ..j-r, -e>. at JO (Iti.nvii or, T, concurring in lisp re.-nlt). The plur.iht o'- ,;,|.ir. nt siigge-lien, ,-cc r.'i,fe. at do, that the ismulele- "ation U-trine iriniht violated it ite- S.-rtvf.irv were permitted to rdtulin- dc.'iui'e fail fiKirrjn..nt ili.,l.|,. n-hs i? plainly wroiic. Fnrli a -lilOlii- Mould he 1(1110' Jefinue and IVeulil thll- raise llij ct.l 1 -tiflllmriiil (;|eslie!i niid.-r Sth,ri,1 I'mithii. \ |. o< u->T. ('i.i'ari'' emild ra'ieu.dlv di'idc Milt u we.rid Is bi-n<-r Iii o'l'MO' iedu-try In bear " f'-a.-ible" costs lli.ni to -iihyit Atnciii.ut viuihcr- to an itxlcienninatc risk of cancer ami Other fatal discvi.-s.-s. de it 2", SXftia. OCCUPATIONAL SAFETY & HEALTH REPORTER it.'gnhile'l imlustriex in ctdor to (diiuinalo rinks of impairment. C'oimtvss did not intend u jnevlude the Scm-tary from tukdng regulatuiy actioii whoa*, u.s hole, no such threat to industry is post'd.'- In order to decide this rm-e. however, it is not necessary to resolve (he question whether the term "feasibility" may con template some balancing of the coats and benefits of regula tory aetiun/1 Inkling into account the uncertainties in exist ing knowledge, the Sern-tury n ade an express finding that the hazards of ben/eiie expensm-,. ".ere sufficient to justify the regulation x costs. A[)p. IGda. Any rerjuirement to balance costs and benefit.? ctimnK bo read to invalidate tlii? wholly rational emichisioti. A eoutrary result, forcing the Secretary tu wait for quantitative data t utt may not be available in tin- foreseeable future, won Id run directly counter to the protective purposes of the Act.*4 Finally, respondents suggest broadly that the Secretary did not fulfill his statutory responsibility to act on the basis of "research, demonstrations, experiments," and to consider "the latest available scientific data i.i the field, the feasibility of the standards, and experience gained under this and other health and safety laws." 2d L*. S. C, - (ion fhj(5) Here, they Contend, the Secretary based Ins decision solely on "views and argument." Brief for Ri'>pund"nts at o2, T dis agree. The Secretary compiled ;iu extensive record composed of over .50 volumes of exhibits. Most uf dnsse exhibits are the reported results of rescaidi and demonstrations represent- Cuiicn-.- .inrijMibv f.,w;ipl (<i.'l-b-ii-fif ijiK die hyi-Lnivr ],i-t,iry yrl y,,r vx.mnile- i- evident tfirougli- `1 In- I'li.-f.' ilait will Sc imnun-.l liv <-mpl<n-r in :n~-nng flic -t.iinlurtU of lieult11 ,m| xif-;y lu tie t--f:i)i!i-)i<-.i unipr dii- '.;j| ,irri |,| ^iv view, rKi-cuiulilf ;,iul ii,., t--.-ary co-is n|' doniir lai.-UM '- '.Vb i ln-r ivc, ,,a in. (iiviKii-.i!-, ini- moliviili-il ( -imjilc Imm.iiiity nt by -imple (-xiiioinii--, we Cull m> longer jH-niii jir'r.'il- i,> !. itej-TiJcnt 11;t i.n iiu.-.i|<; or uiilw-utihy vank'Ui'.'' Lcgi.-. Hi-rery UoO-JJxl (ieu. rhai-'imj. Sinukirly, SYimior Abrru.ruiigli .-r.-iM-i: "We arc talking iiIbhiI- poopU Y ti^e-, not tire indifference of .-oiiie i-o-l iiro.nuiNilit.-. UY an- Talking .ilxiiit ns-nriiig rlie ttien amj uonten who work in our plants ami faemrie- tivu they will go Inline ah'-r a day's work Willi- their lunle-- nn.iif. \YY ;<re t.ilkiiig .itmnf .ir-iinDg our Ainerie.iii worker.- vdii* work unit il. ellv (-ii. iinr ib rh.il ulieli thev tiavo ;i I'CUIIHilii te< I a fv>v \car'. -I'limrilr lli-W Will Hot Inn.- -n i i|j;m la fed ],lns, conjtv-imu .nid |h.i-,>n in fh>ir l-nlii-., ,r -eiiM'dinig rli.n will -mko them (Iwii fielnri ihey reach I'l-fir.-jrieiif ajje." f.cgi> Hi-r.irv AlU = 'h'i>r nec-J I KL'cn-- the [.o--ili.lnv, rai-e'i by ri.ini-el for petituiinr in OT.d argillnenf. di.jf a cl<-'iM.m fri n'gulaie a -idi-laue** pr.-neg a l>..gligit.le threat f(> lieallll and rafety ciaild ii.-elf Im' eh.dli nged a.- arbitrary and T'iiprii'Hjii.- under the Aihiinn.-rratii i: l"rve<'lun- Avl. See Tr. uf Oral Arg.. at. 2:f. 14 lte.-]>0!iil`.|it- aD. rely on th*> linory requir.-mml th.n fh*- Si'cre- tary max- act only to jireveiii ''iciai.-rijl'' iiii]..i)rni*ni. The'- contLinl that the -tandard prouiuegaleil heie din-- !>.' fall nilhin fhai e.Ke^orv f>c<'a*i-i' the n>k L< .*u Imr 't his iiiievjni,t.iti*,u il.-nei- in. -ii;i|(rt frnni I In* statute or it- la -ri.-ta live hi-tofy. The .-t.itiKc it-elf .-fate- dial .-tMiidal'd- -htulM en.-uie tllaU no i-tnplujcfc Will .-iltff-r ''iri.itefial impairmint not material i.'-'i'.' of m.painueiii. Tins language i- (Ditsi-ti-nt with the legi-!.ifi\e bi.-r<iry. In an early W'-'ww (d the Act. the word ``itwi'airnwiu " wa- ea.!ifi.-l bv ",.ny" rather Than "material" See n. V. -.iifji/i Tlu- f.-,..-it.iiif\ and uiateri.ilitv requirements u.-re added -ueiilianeuii-ly as part cl arl effort to qualify lllO i.risriind l.ureiiiiae aulhorixirm the Secretary In en-nre dial "no anpliivec will ,-uffer any impairment of liealtli o' tiuieiKuial eapaeily. or cliinnii-liwl life expectancy." S.-natur r'oiiiiniek was iiiikitih-'I that the pluast- "any*" impa iriiient. wrailit re<|iurc die Secret .ry h. prevent m-ect lute-. f.e"i>. Hi-iory o45. Tint ri.-|uiiuleut,-' coii.-iruerinii wn-.iUl pu-e an ................. . nb-r.iik- to fTorls in regniafe toxie .-uli-iaiK-nn.h r S''.Y">(M(S) The prohatulity of lonlr.ii ling c.liner wff! m a;o-t <<>nv\t.- lie qnile .-mall Willi ie.-peel to any parU'iilar i-Tiiplnyec If the .-taliitr u.-re re.nl to aiirliorire the 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS, INC. WASHINGTON. DC 20037 CURRENT REPORT in" ''the latest available scientific data.'' The Sem-tmy of fered a careful discussion of these data in the statement ui-fumpsinying tin: permanent stand.ini. His ultimate con clusions \Mjre grounded in extensive findings of fact. Where, as Imre, there are gaps in existing knowledge, the Sem-tary's decision must necessarily In; based on considera tions of policy as well as on empirically verifiable facts. In passing the Oecupatimia! Safety and Health Act of 11170, Congress was aware that it '.'..is authorizing the Secretary to regulate in areas of scientific uncertainty. But it intended to require stringent regulation even when definitive informa tion was unavailable. In reducing the permissible level of exposure to benzene, the 8ecrtary applied projier legal stand ards. His determinations arc supported by substantial evi dence. The Secretary's decision was one, then, which the governing legislation authorized him to make." V In recent years there has been increasing recognition that the products of technological development may have harmful effects whose incidence and severity cannot be predicted with certainty. The responsibility to regulate such products has fallen to administrative agencies. Their task is not an en viable one. Frequently no clear causal link can be established between the regulated substance and the harm to be averted. Svi ;'(l i rv to act onlv fy at-.-iir" `'no wii|ilo\.a- will Hilfvr liiat'Tlal ri-k of mip.nrnivin." Ilf StM ny w, .,1.1 lr- dt-.ihii-ii Troin n-ju'ii ling j-ti! i-f :i ut-t--i wlii'li po.-es a .-ni.ill ri-k \wr)i iv-|>i-<-l t<' nay ]).u Iic'dar vnv.li'Vre but will w-m-iln!.-- n-iit>. in ibe uf mikk-filtk' fiK-mhrrs of the enifikwee jmol; 3' MihminU the Oairl of Ai'P<-iN <-<<';>I I ihe Si-rn'l.-try':? finding- {hat (li-rrn-i! ctnii.iii wall i-.ti/cin cun'.l ..him- I < -' i k < - i< i i i . u -n-t a-i(ic the dcrni.ii ...ii .- i -cui.Lir.l Im-im'Ijc i>I tlir S.-i-r.-..in l.nlurc- in |w-rfinvi an rx|>er>:--t*i'n;.-T:<l->t l*i an iinlu.-iri nil n-.-. Tin- failure lo cornliicl I'lis -r. .runiuij :u !)* ciiiirt. vii>l:>i--d ihe -Utlulurv rtx|iMn*itii`i)( that llie s. r- .. : v ,i< i ai tin- Uc-i- nf "dn- In -1 m ailalite v'-idi-iK-e" ana "rhe latent -,\:.i\in<- -<vs".ri.- dill a ill ll'v fielil." !:i rhr :ieari:>c> la-ion- the .-ijji-ih v, p.-'ImhuIciU' |>rrsp!ilt-d no substantial trnli-rge to tlu- pieiti.m dial Ix-iideue could In- abmrbed dumigh the skin, anil llt.-re Ma> i-viilcm-i- in ilk- rirurd to -ii|i|M.rl rluif jH>-ifioii, Belli aiiiiml and Itiiiuau -tiulii-s had found Midi al'Mirjuioii. In thine cimim,-l.cln.-, tile .Secretary Mas Itol uhltgalnl 111 Ulnlerlaki* ai|.litjuu.il studies i111111- 1h-(-:iii-c a (Iif!],->> i.-'iitiial it'.il Mull -tudu-. would in- iiitnnua'ive. Tin- i>ij|>o-iliiiii uf iich a i-ci|mrrmi ni uouM |t.ir.di ze tbe stiiiiil.ird,-i-(i;i'; limn- Trie Scre'.in'- 111.1 n.ii.in is to acl on the bnai.-. of "nv.111.. 1>I-" eiid.-nrc, iuji -\i.|.-iice uludi may Ivi-umr available in the fm nre Tit M-'tilig .`-ii!r> ill!- J.-mral cnn<a.-' -tulld.i rd, 1 In- Court nf Aplieals aleo rei-e-.l un U- (-('thIii-iuii dial die 5,-i-ivlarv had m.i shown tli.il quantifi.iMe In-nt-hl.- 1'ouM rc.-ulr frill!! dll- -lamlar-.l. A- ihr- cli.-i-U'.-iiin abovs ill.1,die 1-iiur: i.|ipliol ........ (feet legal H a lul l pJ.-> ill so holding. 193 Rinks uf harm arc often uncertain, but- inaction ha* considerab'c costs of its own. 'Hie agency must decide whether to take regulatory action against possibly substantial risks or to wait until moil' definitive information becomes available--a jud"meiit which by its very nature cannot be based solely on deter minations iif fact."* Those delegations, in turn, have been made on the under standing that judicial review would be available to ensure that the agency's determinations are supported by substantial evidence and that its actions do not exceed the limits set by Congress, lo the Occupational Safety and Health Act. Con gress expressed confidence that the courts woutd carry out this important rosixmsibilHy. But in this case the plurality has far exceeded its authority. The plurality's "threshold finding requirement is nmduTf to lie found in the Act and is antithetical to its basic purposes. "The fundamental policy questions appropriately resolved in Congress . . . are imt subject to re-exjiininatioii in the federal courts under the guise of judicial levnus uf agency action." VurjfKTiit Yankee XtuU-ar Bmrer Cnrp. v. SU1)V, 4:15 U. S. 519. 55R (1978) lemphasis in original). Surely this is no l<-ss true of the decision to ensure safety for the American worker than the decision to piocied with imch-ar power, fv-c: ibid. Because tin: approach taken by the pluridily is so plainly irreconcilable with the ('ousts proper institutional role. 1 am (eitiun that it will not stand the test of time. In all likeli hood. today s decision u dl come lo be regarded ns an .extreme reaction to n regulatory scheme that, as the Members of the pbu ably priceil ed it. imposed un unduly harsh burden on regulated industries. But ns the Constitution "dues not enact Mr. Hi-rb-rt spencer's Social Statics.'* Lochner v. AYu' 1 urk, 198 L*. S. 4o, 75 (3905) (Holmes, J., dissenting), so the iespnti-fibi|;iy to scrutinize federal administrative notion does nut authorize this Court to strike its own balance between the costs and benefits of occupational safety standards. I um confident that the approach taken by the plurality today, like that in hoc/mer itself, will eventually be abandoned, and that the representative branches of government will once again be allowed to determine the level of safety and health protec tion to be accorded to the American worker. ' Sr . T ..w-f-..<i; \i ri.|it.ili|i- ffi-k -Sr-i, II..,- ;tlul iIn- IVlermtiia- n,|,i nf >alcii Siciv-iri, O.ir-cdi'M-- of l.ilieriy. 'lun-chlv and h ran-utilv; Hu- < u!l,-,mc N.itnr.- nf Ktivm>imirtil:d (ju.-ilifi- .mil ,fn<liciaI i<>-si.-ii of Aitnnin-l i .mve Aciiuit, 7 Kiivin-iiuirnlal I,:w% zigj |tjll--f7'J 7-10-80 Published by THE BUREAU OF NATIONAL AFFAIRS. INC . WASHINGTON. D C 20037 **iiL i i 194 l-'Lt Journal MEETINGS SCHEDULED July 24-25 -- Toxic Chemical Safety, Washington, D.C. (Registrar, Starson Corp., NHCI Div., P.O. Box 133, Stan ton, N.J. 08885; tel: (215) 258-7045). The course also will be held August 4-5 in Milford, Conn.. August 11-12 in Scranton, Pa., and August 18-19 in Wayne, N.J. July 28-August 1 -- Auditing Safety Program Management for Corporate Safety Directors, Atlanta, Ga. (International Loss Control Institute, P.O. Box 345, Loganville, Ga. 30249; tel: (404) 466-2208). July 28-August I -- Design and Evaluation of Industrial Ventilation Systems, Salt Lake City, Utah (RMCOEH, Attn: Katherine Blosch, Bldg. 112, Univ. of Utah, Salt Lake City, Utah 84112; tel: (801) 581-5710). July 30 -- How to Implement a Safety Program, Burbank, Calif. (Training Institute, 616 South Westmoreland Ave., Los Angeles. Calif. 90005; tel: (213) 385-6461). August 4-5 -- Hazardous Chemical Safety, Chicago, 111. (Carol Morris, J.T. Baker Chemical Company, Phillipsburg, N.J. 08865; tel: (201) 454-2500). The course also will be held August 7-8 in Cincinnati, Ohio, August 11-12 in Houston, Tex., August 14-15 in Atlanta, Ga., August 18-19 in Seattle, Wash., and August 21-22 in San Francisco, Calif. August 4-7 -- Hazardous Chemical Safety Management, Orlando, Fla. (Short Course Registrar, Eastek Corp., 3543 Baldwin Drive. Easton. Pa. 18042; tel: (215) 252-1737). The course also will be held August 18-21 in Minneapolis, Minn. August 4-8 -- Basic Safety Management, Houston, Tex., (International Safety Academy. P.O. Box 19600, 10575 Katy Freeway. Houston. Tex. 77024; tel: (713) 932-9400). August 4-8 -- Loss Control Management, Atlanta, Ga. (International Loss Control Institute, P.O. Box 345, Loganville, Ga. 30249; tel: (404) 466-2208). August 6-7 -- Hazardous Material Safety, Milford, Conn. (Registrar, Starson Corp., NHCI Div., P.O. Box 133, Stan ton. N.J. 08885; tel: (215) 258-7045). The course also will be held August 20-21 in Wayne, N.J. August 7-8 -- Fertilizer Safety, Salt Lake City, Utah (Maurice L. Greiner, Intermountain Fertilizer Safety School, c/o J.R. Simplot Company, P.O. Box 912, Pocatello, Idaho 83201; tel; (208) 232-6620, ext. 338). August 11-22 -- Industrial Hygiene Measurements, Los Angeles, Calif. (Institute of Safety and Systems Manage ment, Univ. of Southern Calif., University Park, Los Angeles, Calif. 90007). August 14-15 -- Pulmonary Function Testing for Industrial Nurses, Houston, Tex. (Occupational Lung Clinic, Inc., 7777 Southwest Freeway, Suite 442, Houston, Tex. 77704; tel: (713) 777-4399). August 18-22 -- Fundamentals of Modem Safety Manage ment, Sacramento, Calif. (International Loss Control Institute, P.O. Box 345, Loganville, Ga. 30249; tel: (404) 466-2208). August 18-22 -- Development and Growth of .a Modern Safety Program, Sacramento, Calif. (Ernest Chaney, Inter national Loss Control Institute, P.O. Box 345, Loganville, Ga. 30249; tel: (209) 485-3720). August 19-21 -- Recognition, Evaluation, and Control of Occupational Health Hazards, Monroeville, Pa. (Michael Russak, Industrial Health Foundation, 5231 Centre Ave., Pittsburgh, Pa. 15232; tel: (412) 687-2100). Occupational Safety & Health Reporter