# Petition for Writ of Certiorari — National Cottonseed Products Ass'n v. McLaughlin > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385019_1242%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition for Writ of Certiorari - **Published:** January 1, 1988 - **Citation:** 485 U.S. 1020 ## Text eh (IRI 87-1214 9 [FR dw aerrs No. 87- JAN 20 J988 SPANIOL, JR. | —«! IN THE Supreme Court of the United States OCTOBER TERM, 1987 NATIONAL COTTONSEED PRODUCTS ASSOCIATION, Petitioner, . 2 ANN DORE MCLAUGHLIN, SECRETARY OF LABOR, e¢ al., Respondents. PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT CARL W. VoctT * KEITH A. JONES CAROL BARTHEL FULBRIGHT & JAWORSKI 1150 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 452-6800 * Counsel of Record WILSON - EPES PRINTING Co., INC - 789-0096 - WASHINGTON, D.C. 20001 QUESTION PRESENTED Whether, notwithstanding holdings to the contrary in Industrial Union Department v. American Petroleum In- stitute, 448 U.S. 607 (1980), and Texas Independent Ginners Association v. Marshall, 630 F.2d 298 (5th Cir. 1980), the Occupational Safety and Health Administra- tion may promulgate an occupational health standard requiring employers to provide and pay for medical ex- amination and testing of employees, in circumstances where there is no significant current risk to health and no factual basis for imposing any other occupational health standard.* * In addition to the persons named in the caption, Eula Bingham, Assistant Secretary of Labor, and the Occupational Safety and Health Administration were parties to the proceeding in the court of appeals. The opinion of the court of appeals also disposed of a separate proceeding to which the same federal officers and agencies and the Minnesota Mining and Manufacturing Company were parties. (i) TABLE OF CONTENTS QUESTION PRESENTED ........................ og fe! er eedaauliqudcmansausiodecen sansa sacademaagnerndonninhsnsons jatasinaisagonse STATUTES AND REGULATIONS ISVOLVED....... th a lt AR Ce bo Statutory background ................. The cottonseed processing industry ..................... Initial regulation of exposure to cotton dust in the cottonseed processing industry -.................. OSHA’s promulgation of an occupational health standard requiring medical examination and ERR Rc cabbie Review of the health standard by the court of appeals ............ 2 2 SP) TP IEE EP RD ONE AT TR GORE R REASONS FOR GRANTING REVIEW ........................ 1. The decision below conflicts with IJndustrial Union Department and Texas Independent i REISS oc ee ae a oe SEED Se Nace re 2. Even apart from those conflicts, the decision below was incorrect and the issue is important.. CONCLUSION eh nak; PROCTER A ROPE ILA Ea he ED (iii) ~] 12 16 ‘aa ata ii iv TABLE OF AUTHORITIES CASES Page AFL-CIO v. Marshall, 617 F.2d 636 (D.C. Cir. 1979), aff'd on other grounds sub nom Ameri- can Textile Manufacturers Institute v. Donovan, UD Te CE anntcccntcaccenissetenctentecieen 4 Industrial Union Department v. American Petro- leum Institute, 448 U.S. 607 (1980) _...-.. 0... passim Louisiana Chemical Association v. Bingham, 657 Fe Oe ee a RD earch ei eee 13 Pratt & Whitney Aircraft v. Secretary of Labor, G49 F.24 96 (Za Cir. 1981) .................. A OR Gol 12 Texas Independent Ginners Association v. Mar- shall, 630 F.2d 398 (5th Cir. 1980) .....000....... 4g Ge Bly 2D STATUTES: ee ees We OD ore ee 1 29 UBC. § GSSCB) on. oooecccccdcccccccecens. CBF Sod Lee! RIAN. passim Fe IY a he i eect we ge passim 29 U.S.C. § 669(a)........... EE IIE Se ANG PSP IEA 15 Rp Ske YS | RE ees ete eee REC MCE RN 15 CODE OF FEDERAL REGULATIONS: 29 C.F.R. § 1910.10438 ............... Sa nie entered LeRoi passim OTHER: AT Fed. Reg. 5906 (Feb. 9, 1982) ...............2...020- 22000... 4 48 Fed. Reg. 26962 (June 10, 1983) ..............0.0200.00..... 4,5 50 Fed. Reg. 51120 (Dec. 13, 1985) ............2..2002-000.. passim IN THE Suprenw Court of the United States OCTOBER TERM, 1987 No. 87- NATIONAL COTTONSEED PRODUCTS ASSOCIATION, Petitioner, V. ANN Dore MCLAUGHLIN, SECREPARY OF LABOR, et al.. Respondents. PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT The National Cottonseed Products Association hereby petitions for a writ of certiorari to review the judgment of the United States Court of Appeals for the District of Columbia Circuit in this case. OPINION BELOW The opinion of the court of appeals (App. A) is re- ported at 825 F.2d 482. JURISDICTION The judgment of the court of appeals (App. B) was entered on August 7, 1987. A timely petition for rehear- ing. with suggestion of rehearing en hane, was denied on October 23, 1987 (App. ©:. This Court’s jurisdiction is invoked under 28 U.S.C. § 1254/1). 2 STATUTES AND REGULATIONS INVOLVED The pertinent provisions of section 3'8) and 6'b) of the Occupational Safety and Health Act of 1970, 29 U.S.C. §$ 652'8) and 655:b! (1982), and of 29 C.F-.R. £ 1910.1043 (1987) are set forth at Appendix D. STATEMENT This case was heard by the United States Court of Appeals for the District of Columbia Circuit on a_peti- tion filed by petitioner National Cottonseed Products As- sociation for review of an occupational health standard promulgated by the Occupational Safety and Health Ad- ministration (“OSHA”) pursuant to section 6'b) of the Occupational Safety and Health Act of 1970, 29 U.S.C. £655'b) (1982). The jurisdiction of the court of ap- peals rested on section Sif! of the Act. 1. Statutory background. Section 3(8) of the Act, 29 U.S.C. § 65218), defines the term “occupational safety and health standard” as “a standard which requires con- ditions. or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably nec- essary or appropriate to provide safe or healthful em- ployment and places of employment.” Section 6(b) gov- evas the promulgation of “any occupational safety or health standard.” Section 6'b! (5) specifically provides for “standards dealing with toxic materials or harmful physical agents.” Section 6(b)‘7) further provides that “lijn addition, where appropriate, any such standard shall prescribe the type and frequency of medical exami- nations or other tests which shall be made available, by the employer or at his cost, to employees exposed to such hazards.” In this case, OSHA prescribed an occupational health standard for the cottonseed processing industry that requires medical examination and testing of employ- ees but does not impose any limitation on exposure to a toxic material or harmful physical agent. 3 2. The cottonseed processing industry. The cottonseed processing industry comprises approximately 50 cotton- seed oil mills nationwide. The mills process cottonseed into four components—oil, linters, hulls, and meal. Cot- tonseed oil is edible and is used in many foods for human consumption. Linters, the short fuzz fibers on the ex- terior of a seed, are used in cellulose products and cotton batting. Hulls, the tough outer covering of the seed, and meal, the granular material remaining after extraction of the oil, are used in animal feed. Cottonseed processing is seasonal, and worker turnover is extremely high. 50 Fed. Reg. 51120, 51136 ‘Dee. 13, 1985'. It is estimated that “on average only 6 percent of the workforce remain employed for a full year.” Jd. at 51171. The total industry “workforce is relatively small, about eight hundred.” /d. at 51136. Cottonseed processing “is very much a declining industry. The num- ber of facilities has been decreasing and many are small] businesses.” Jd, 3. Initial regulation of exposure to cotton dust in the cottonseed processing industry. In 1971, OSHA exercised authority under section 6‘a! of the Act to adopt a “na- tional consensus standard” applicable to all industries, specifically including cottonseed processing, whose em- ployees are exposed to cotton dust at the workplace. See App. A at 3a. The standard prescribed a limit of 1000 ug m* on exposure to all cotton dust. See 50 Fed. Reg. at 51123. In 1978, acting pursuant to section 6b) of the Act, OSHA promulgated a new “occupational safety or health standard” by setting “permissible exposure limits of 200 ug m* of lint-free respirable cotton dust, averaged over eight hours, for yarn manufacturing: 750 ug m®* for slashing and weaving operations; and 500 ug/‘m* for knitting and nontextile industries !including cottonseed processing} which used cotton.” Jd. at 51124. OSHA 4 explained that “|t}his new standard was intended to supersede the previous OSHA standard [of 1000 ug m°*}.” 47 Fed. Reg. 5906 (Feb. 9, 1982). On petition for re- view, the limit of 500 ug m* on exposure to lint-free respirable cotton dust was vacated with respect to cot- tonseed processing because the record did not support OSHA's finding of economic feasibility for that indus- try. AFL-CIO v. Marshall, 617 F.2d 636, 669-73 (D.C. Cir. 1979), aff'd on other grounds sub nom, American Textile Manufacturers Institute v. Donovan, 452 U.S. 490 (1981). Thereafter, OSHA took the position that the limit of 1000 ug m on exposure to all cotton dust remained in effect for cottonseed processing pending further rulemak- ing. See 50 Fed. Reg. at 51122. OSHA acknowledged, however, “that the cottonseed industry was not in com- pliance with [that limit] and that [such] compliance .. . could cause severe economic disruptions in the industry.” Id. at 51135. 4. OSHA’s promulgation of an occupational health standard requiring medical cxamination and testing. Early in 1982, OSHA undertook a “reevaluation of the occupational health standard regulating employee expo- sure to cotton dust.” 47 Fed. Reg. at 5906. The public was asked to comment on, inter alia, “the evidence of risk of adverse health effects in workers exposed to cot- ton dust in non-textile industries.” /d. at 5907. In 1983, after receiving numerous comments, OSHA proposed “to eliminate from coverage from |the regula- tions pertaining to cotton dust] several segments of the nontextile industry [including cottonseed processing! where there is no evidence of significant risk.” 48 Fed. Reg. 26962 ‘June 10, 1982). OSHA noted that the oe- cupational health standard promulgated in 1978 had been based upon the assumption “that the large body of risk evidence in the textile industries could be used to support the less conclusive evidence in nontextile operations.” 5 Id. at 26965. Because “the composition of cotton dust varies from one operation to another,” id. at 26966, OSHA had decided “to review the existing scientific evi- dence to determine whether or not a significant risk of adverse health effects exists for workers . . . in each of the nontextile industries covered by the 1978 standard.” ld. After conducting that review, OSHA had concluded that “none of the available studies provided evidence of significant long-term adverse health effects in individual workers in cottonseed processing operations that are equivalent to those currently existing in the United States.” /d. at 26967. OSHA also had concluded that “there is a serious question as to whether [the earlier limit of 1000 ug m* on exposure to all cotton dust] is economically feasible.” Jd. at 26968-69. OSHA therefore requested comments “on alternative approaches to pro- tecting worker health in the cottonseed processing indus- try which would be economically feasible.” Jd. at 26969. In late 1985, after receiving-and reviewing further comments and other evidence, OSHA determined that cottonseed processing “workers exposed at levels equal to '. to 2 times the present exposure limit do not have an increased incidence of byssinosis or bronchitis [i.e., the health impairments associated with exposure to cotton dust in the textile industries] compared to controls.” 50 Fed. Reg. at 51135. OSHA therefore “conclude{d] there is not sufficient evidence of significant risk which could be substantially reduced by lowering exposure limits to justify applying the exposure limit [of 500 ug m"} ... to the cottonseed industry.” /d. OSHA also “conclude/d] that a significant health risk will not develop if the 6(ai limit [of 1000 ug m‘] is repealed for {cottonseed proc- essing]. /d. at 51136. Consequently, OSHA exempted cottonseed processing from all regulatory limits on ex- posure to cotton dust. Jd. at 51135. Although it had not found any significant risk of ma- terial health impairment from exposure to cotton dust in ve Se ee Or! in SE a ee Oe ee 6 the cottonseed processing industry, OSHA nonetheless promulgated an occupational health standard requiring medical examination and testing of cottonseed processing workers. OSHA reasoned: a backstop is clearly needed with the elimination of the permissible exposure limit to assure that byssi- nosis and chronic bronchitis do not develop after- wards. This is especially true because cotton seed processing is a dusty process and the possibility ex- ists that exposures will rise above current levels. In addition, there is a clear medical need for... medical surveillance. . . . [{Mjedical surveillance would allow identification of persons “unusually sus- ceptible to adverse effects of this dust” and [of] “nersons with active airway diseases . . . [who] should not be assigned to particularly dusty jobs.” Id. at 51135-36. The new standard requires each employer in the cot- tonseed processing industry to “institute a program of medical surveillance for all employees exposed to cotton dust.” 29 C.F.R. § 1910.1043(h) (1) (i). The employer must conduct medical testing on the first day of employ- ment both “prior to initial assignment” and “no less than 4 and no more than 10 hours after the beginning of the work shift” and also must conduct periodic medical examinations for some employees every six months and for each employee “at least every two years.” Jd. at $ 1910.1043(h) (2), (3). The medical examination and testing must be performed by or under the supervision of a licensed physician, and the employer must obtain from the physician a written medical opinion and _ rec- ommendation for each employee. Jd. at § 1910.1043 (h) (1) (ii), 5(i). The employer must “establish and maintain an accurate medical record for each employee subject to medical surveillance ... for at least 20 years.” Id. at § 1910.1043(k) (2). 7 5. Review of the health standard by the court of ap- peals. The court of appeals sustained the requirement of medical examination and testing. The court acknowl- edged that this Court in /ndustrial Union Department v. American Petroleum Institute, 448 U.S. 607 (1980), had ruled that OSHA “must make a threshold finding of significant risk,” App. A at 3a, before prescribing an occupational safety or health standard under section 6(b) of the Act. But the court of appeals “h[e]ld that this requirement is substantially modified when the sole requirement imposed is one of monitoring employee health.” Jd. The court determined that OSHA may promulgate an occupational health standard requiring medical examina- tion and testing whenever “there is a real possibility of significant health risks.” App. A. at 8a. Although OSHA had not explicitly found even that “real possibil- ity,” the court believed that the necessary finding was implicit in OSHA’s explanation of why medical examina- tion and testing was being required. Jd. REASONS FOR GRANTING REVIEW The court of appeals has held that OSHA may promul- gate an occupational health standard requiring employ- ers to provide and pay for medical examination and test- ing of employees in circumstances where there is no sig- nificant current risk to health and no factual basis for imposing any other occupational health standard. This holding conflicts with the decision of this Court in /ndus- trial Union Department and with that of the Fifth Cir- cuit in Texas [ndependent Ginners Association v. Mar- shall, 630 F.2d 398 (5th Cir. 1980). The issue is important. The decision below empowers OSHA, without the bothersome necessity of first finding that working conditions pose a real and discernible risk to health, to direct employers in each and every industry in the United States to furnish medical examination and 8 testing for employees. OSHA can do this, according to the court of appeals, as a means of monitoring working conditions to determine whether they continue to be safe. The Act does not sanction that. Providing medical examination and testing is costly and burdensome. Placing the responsibility on employers to conduct such medical surveillance, merely as a means of gathering information and where there is no signifi- cant current risk to health, is akin to exacting a special tax for the purpose of funding government research. Congress did not intend the device of mandatory occupa- tional health standards to be used for that purpose or in such an intrusive and indiscriminate manner. 1. The decision below conflicts with Industrial Union Department and Texas Independent Ginners. In Jndus- trial Union Department, this Court struck down an oc- cupational health standard relating to exposure to ben- zene at the workplace. Justice Stevens, writing for a plurality of four Justices, reasoned that every occupa- tional health standard must “satisfy the basic definition in §3/8).” 448 U.S. at 642. Section 3/8) applies “to all permanent standards promulgated under the Act and it requires the Secretary, before issuing any stand- ard, to determine that it is reasonably necessary and ap- propriate to remedy a significant risk of material health impairment.” Jd. at 639. By empowering the Secretary to promulgate stand- ards that are “reasonably necessary or appropriate to provide safe or healthful employment and places of employment,” the Act implies that, before promul- gating any standard, the Secretary must make a finding that the workplaces in question are not safe [A] workplace can hardly be considered “un- safe” unless it threatens the workers with a signifi- cant risk of harm. Therefore, before he can promulgate any perma- nent health or safety standard, the Secretary is re- 9 quired to make a threshold finding that a place of employment is unsafe—in the sense that significant risks are present and can be eliminated or lessened by a change in practices. This requirement applies to permanent standards promulgated pursuant to §6(b) (5), as well as to other types of permanent standards. Id. at 642 (emphasis in original). The benzene stand- ard was invalid “{b]ecause the Secretary did not make the required threshold finding.” Jd. at 640.’ The court of appeals in this case held that OSHA was not required to make a threshold finding of significant risk, stating that “an unusually precise dictum in [J/n- dustrial Union Department] applies to this case and sanctions the Secretary’s determination.” App. A. at 4a. The court relied upon the following passage from the plurality opinion in Industrial Union Department: [I]n setting a permissible exposure level in reliance on less-than-perfect methods, OSHA would have the benefit of a backstop in the form of monitoring and medical testing. Thus if OSHA properly determined that the permissible exposure level should be set at 5 ppm, it could still require monitoring and medical testing for employees exposed to lower levels. By doing so, it could keep a constant check on the valid- ity of the assumptions made in developing the per- missible exposure limit, giving it a sound evidentiary basis for decreasing the limit if it was initially set too high. 448 U.S. at 657-58 (footnotes omitted). The court of appeals concluded that if medical surveillance may be used as a backstop when OSHA has set a permissible ex- 1 Justice Rehnquist concurred in the judgment on the ground that section 6(b)(5) of the Act is a standardless delegation of legisla- tive authority, the enactment of which was not constitutionally justified by inherent necessity. See 448 U.S. at 671-88. 19 posure level based upon a finding of significant risk, such surveillance also may be required when OSHA has found no significant risk and has imposed no permissible ex- posure level. That conclusion is an obvious non sequitur. The court of appeals misread the passage from /ndus- trial Union Department on which it relied. In that pas- sage, the plurality merely described the use of monitoring and medical testing as an adjunct to a validly imposed permissible exposure level. The passage does not imply that a requirement of medical surveillance could be im- posed on its own, in the absence of a permissible exposure level or other substantive health standard. Nor does the language of section 6‘b) (7) contemplate a free-standing requirement of medical surveillance. It merely authorizes OSHA to require medical examinations as an “addition, where appropriate,” to an otherwise valid substantive health standard. But even if section 6(b) (7) could be read as author- izing the imposition of a free-standing requirement of medical surveillance, OSHA stil] would have to make the threshold finding identified in /ndustrial Union Depart- ment. An occupational health standard prescribing med- ical examination and testing pursuant to section 6(b) (7), no less than one imposing a permissible exposure level pursuant to section 6/(b) (5), must satisfy the basic defi- nition of section 3(8). That definition governs “all per- manent standards promulgated under the Act,” 448 U.S. at 639 (plurality opinion) (emphasis added), and thus a threshold finding of a significant risk to health must be made before OSHA “can promulgate any permanent health or safety standard.” Jd. at 642 (emphasis in orig- inal). The occupational health standard prescribed by OSHA for the cottonseed processing industry does not pass muster. Because “the agency simply did not find evidence of significant risk,” App. A. at 8a, it had no law- ful basis for requiring medical examination and testing. 11 The court below erred in reading the “unusually pre- cise dictum” in Industrial Union Department as carving out an exception from the requirement of a threshold finding of significant risk. The occupational health stand- ard there at issue not only established a permissible ex- posure level for benzene but also required employers “to provide semiannual medical examinations for their ex- posed employees.” 448 U.S. at 627 (plurality opinion). Four Justices believed that the benzene standard was valid in its entirety. See 448 U.S. at 688-724 (Marshall, J., dissenting). Another three Justices (those subscrib- ing in full to the plurality opinion) believed that the benzene standard was invalid only because it had not been based upon a finding of significant risk of material harm.” If, as the court below concluded, a requirement of medical examination and testing may be imposed even in the absence of a finding of significant risk, seven mem- bers of this Court would have voted to sustain the sep- arate portion of the benzene standard that imposed that requirement. But the Court invalidated the entire stand- ard, including the requirement that employers provide medical examinations. The decision below thus conflicts both with the plurality’s reasoning in Jndustrial Union Department and with the Court’s disposition of the case on the merits. The decision below also squarely conflicts with the Fifth Circuit’s holding in Texas Independent Ginners. There, as here, OSHA had prescribed an occupational health standard for an industry, cotton ginning, whose employ- ees are exposed to cotton dust. As in this case, OSHA had not found a risk to health sufficient to justify the imposition of a permissible exposure level, but it had re- quired employers to “provide medical surveillance of ex- 2 Justice Powell, who joined in most of the plurality opinion, be- lieved that the benzene standard also was invalid because OSHA had failed to determine whether economic costs bore a reasonable relationship to expected benefits. See 448 U.S. at 664-71. 12 posed employees.” 630 F.2d at 402. The Fifth Circuit, reasoning that “[t]he Act authorized only those OSHA regulations that are elicited by a significant risk of un- safe or unhealthful employment or workplaces, and that are reasonably necessary or appropriate to reduce that risk,” id. at 405, struck down the requirement of medical surveillance “because OSHA has not found as a ‘threshold matter’ that cotton dust poses a ‘significant health risk’ in cotton gins .. . and that a standard is ‘reasonably necessary or appropriate to provide safe or healthful em- ployment and places of employment.’” Jd. at 406.* 2. Even apart from those conflicts, the decision be- low was incorrect and the issue is important. The lower court’s determination in this case that a requirement of medical examination and testing may be imposed under section 6(b)‘7) of the Act upon the finding of a mere “nossibility” of health risks, App. A. at 8a, is pure invention. It has no basis in the statutory text or legis- lative history. “The Act is intended only to guard against significant risks, not ephemeral possibilities.” Pratt & Whitney Aircraft v. Secretary of Labor, 649 F.2d 96, 104 (2d Cir. 1981). Section 6(b) (7) itself provides no guidance concerning when OSHA may require employers to conduct medical examination and testing. If that provision stood alone, it would run afoul of “the nondelegation principle of separation of powers.” Industrial Union Department, 448 U.S. at 674 ‘Rehnquist, J., concurring). But section 6(b) (7) does not stand alone. It permits the imposition of medical surveillance only as an “occupational safety and health standard,” as defined by section 3(8), and it contemplates that such surveillance will be only one com- ponent of an occupational health standard dealing more 3 Although Texas Independent Ginners was discussed in the parties’ briefs, the court below did not refer to that case in its opinion. 13 broadly with a toxic material or harmful physical agent pursuant to section 6(b) (5). In view of this relation- ship among the three provisions, there is no statutory warrant for the lower court’s conclusion that the prom- ulgation of health standards under section 6(b) (7) uniquely may be based upon a different and lower thresh- old finding. Section 6(b)(7) necessarily incorporates the legislative standards of sections 3(8) and 6(b) (5). The Act contemplates that OSHA must make the same adequate threshold finding of risk for all occupational health standards. At bottom, the decision below reflects the lower court’s belief that it is appropriate for OSHA to require em- ployers to provide and pay for medical examination and testing of employees solely for the purpose of gathering data concerning possible or potential risks to health. That belief is in error: Congress conceived [an occupational health] stand- ard as a remedial measure addressed to a specific and already identified hazard, not as a purely ad- ministrative effort designed to uncover violations of the Act and discover unknown dangers. In short, standards should aim toward correction rather than mere inquiry into possible hazards. Louisiana Chemical Association v. Bingham, 657 F.2d 777, 782 (5th Cir. 1981). OSHA sought to justify its “inquiry into possible hazards” in this case on the ground that, because cotton- seed processing was being exempted from the exposure limit of 1000 ug/m* that earlier had been imposed under section 6(a), “the possibility exists that exposures will rise above current levels.” 50 Fed. Reg. at 51135. This was rank speculation, with no basis in the rulemaking record. There had been substantial uncertainty, even within OSHA, concerning whether the 1000 ug/m®* limit had remained in effect at all after 1978. Compare 47 14 Fed. Reg. at 5906 (the 500 ug/m* limit on lint-free re- spirable cotton dust promulgated in 1978 “supersede[d] the previous OSHA standard” of 1000 ug,m* in ail cot- ton dust) with 50 Fed. Reg. at 51122 (asserting that the limit of 1000 ug/m* remained in effect). Whether or not the 1000 ug/m* limit technically remained in effect, OSHA had conceded that the limit was not economically feasible and that cottonseed processors were not comply- ing with it. 7d. at 51133. Exempting cottonseed process- ing from a limit that had not been generally understood to be in effect, and that had not been complied with, was unlikely to cause an increase in exposure levels. Of course, there is always a theoretical possibility in any industry that a change in working conditions may result in increased exposure to potentially unhealthful -~materials or agents. If such a merely theoretical possi- bility of increased exposure justified promulgation of an occupational health standard requiring medical examina- tion and testing, OSHA could promulgate such a stand- ard for every industry in the United States. Medical surveillance is both costly and enormously in- convenient for the employer. This is especially true in the cottonseed processing industry. Cottonseed oil mills are located in rural areas where physicians are scarce. During the processing season, the mills operate around the clock; employee turnover is extremely high, and new workers may be hired on any day and for any shift. The occupational health standard that OSHA has imposed re- quires that, on his first day of work, each new employee be given two medical examinations cenducted “by or un- der the supervision of a licensed physician,” one before the start of work and a second ‘“‘no less than 4 and no more than 10 hours after the beginning of the work shift.” 29 C.F.R. § 1910.1043¢h) (1) (ii), (2) (iii). This requirement is both expensive and wholly insensitive to the realities of the workplace. ~ 15 Other industries can expect to encounter similar costs and inconveniences. Such burdens on private industry might be reasonable where the workplace has _ been shown to be hazardous. But they are wholly unreason- able when OSHA’s objective is the mere collection of data. Congress foresaw that there would be situations, like that presented in this case, where OSHA would desire to gather additional data on a continuing basis even though it was unable to identify any significant risk of harm currently existing at the workplace. To deal with such situations, Congress empowered the National In- stitute of Occupational Safety and Health (“NIOSH”) to conduct wide-ranging research relating to occupational health, including the conduct of “‘such programs of medi- cal examinations and tests as may be necessary for de- termining the incidence of occupational illnesses and the susceptibility of employees to such illnesses.” Section 20(a) (5) of the Act, 29 U.S.C. § 669(a) (5). NIOSH also is authorized, under section 22(d) of the Act, 29 U.S.C. § 671(d), to conduct research and experimental programs for the development of new or improved health standards. Congress did not authorize OSHA to bypass NIOSH, and to impose the cost of gathering data directly on the employer, in the absence of a finding of an actual and significant current risk to health.‘ * Indeed, section 6(b)(7) provides that, even when an appropriate finding has been made, the government may defray the cost of “such medical examinations [as! are in the nature of research.” 16 CONCLUSION The petition for a writ of certiorari should be granted. Respectfully submitted, CARL W. VocT * KEITH A. JONES CAROL BARTHEL FULBRIGHT & JAWORSKI 1150 Connecticut Avenue, N.W. Washington, D.C. 20036 (202) 452-6800 * Counsel of Record APPENDICES la APPENDIX A UNITED STATES COURT OF APPEALS DISTRICT OF COLUMBIA CIRCUIT Nos. 78-2014, 86-1075 and 86-1157 NATIONAL COTTONSEED PRODUCTS ASSOCIATION, Petitioner, WILLIAM E. Brock, Secretary of Labor, United States Department of Labor and EULA BINGHAM, Assistant Secretary of Labor, United States Department of Labor; OCCUPATIONAL SAFETY AND HEALTH ADMIN- ISTRATION, United States Department of Labor, Respondents. NATIONAL COTTONSEED PRODUCTS ASSOCIATION, Petitione rs ¥. WILLIAM E. Brock, Secretary of Labor, U.S. Department of Labor, et al., Re sponde nts. MINNESOTA MINING AND MANUFACTURING COMPANY, Py tit 10 V. OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, et al., 2a Argued Jan. 16, 1987 Decided Aug. 7, 1987 As Amended Aug. 13, 1987 Before ROBINSON, GINSBURG and WILLIAMS, Circuit Judges. Opinion for the Court filed by Circuit Judge RUTH B. GINSBURG and Circuit Judge WILLIAMS. RUTH B. GINSBURG, Circuit Judge, and WIL- LIAMS, Circuit Judge: Two remnants of the cotton dust rulemaking are pre- sented to us following extensive judicial and administra- tive consideration of the regulations. See AFL-CIO v. Marshall, 617 F.2d 636 (D.C.Cir.1979), aff'd in part sub nom. American Textile Manufacturers Institute, Inc. v. Donovan, 452 U.S. 490, 101 S.Ct. 2478, 69 L.Ed.2d 185 (1981); see generally 50 Fed.Reg. 51,123-25 (1985). The first challenge, pressed by the National Cottonseed Products Association (NCCPA), concerns Occupational Safety and Health Administration (OSHA) prescrip- tions for medical surveillance of workers exposed to cot- ton dust. The second challenge, framed by Minnesota Mining and Manufacturing Company (3M), concerns OSHA’s effectiveness rating for the disposable respira- tors that 3M manufactures. We conclude that OSHA acted within its statutory authority and on a rational basis; we therefore deny the petition for review. I. NCPA PETITION NCPA raises a question as to the scope of the Supreme Court’s holding in /ndustrial Union Department, AFL- CIO v. American Petroleum Institute, 448 U.S. 607, 100 S.Ct. 2844, 65 L.Ed.2d 1010 (1980) {hereinafter Ben- 3a zene|, that OSHA, in promulgating standards for toxic substances under § 6(b) (5) of the OSH Act, 29 U.S.C. $ 655(b) (1982), must make a threshold finding of sig- nificant risk. We hold that this requirement is substan- tially modified when the sole requirement imposed is one of monitoring employee health, and that the Secretary’s findings here are sufficient. NCPA also claims that the monitoring requirements are not feasible for the cotton- seed industry; we reject the contention. A. Background Section 6(a) of the OSH Act, 29 U.S.C. § 655(a) (1982), authorizes OSHA to adopt any “national con- sensus standard” as one of its own. In 1971 OSHA exer- cised this power as to cotton dust, adopting the 1000 ug‘m* permissible exposure limit (“PEL”) that had been promulgated under the Walsh-Healey Act, 41 U.S.C. s 35(e) (1982). Section 6(b) of the OSH Act authorizes independent promulgation of standards, and in 1978 OSHA exercised that grant. Determining that the dust generated by cottonseed mills posed a material risk to cottonseed workers’ health, it set a PEL of 500 ug/m* and required employers to adopt medical surveillance programs. 43 Fed.Reg. 27,350 (1978). On appeal, this court agreed that exposure to cotton dust presented a material risk of harm, but remanded for reconsidera- tion or further explanation of the standard’s economic feasibility. AFL-CIO v. Marshall, 617 F.2d 636, 666-73 (D.C.Cir.1979), aff'd on other grounds sub nom. Ameri- can Textile Manufacturers Institute v. Donovan, 452 U.S. 490, 101 S.Ct. 2478, 69 L.Ed.2d 185 (1981). Thus, the 500 ug m* PEL has never taken effect but the 1000 ug’m* limit has remained in place continuously since 1971. On remand, the agency reconsidered both the need for dust regulations in the cottonseed industry and _ their feasibility. 47 Fed.Reg. 5906 (1982). During this rule- 4a making new studies of the domestic cottonseed industry came to light, indicating that, contrary to the Secretary’s previous findings, “excess byssinosis and bronchitis are not present among U.S. cottonseed workers.” 50 Fed. Reg. 51,120, 51,185 (1985). However, the record also indicated that a subset of hypersensitive workers suffers from respiratory ailments, as do a very high percentage of workers in foreign cottonseed mills (where dust levels are much higher), and that the precise causal link be- tween cotton dust and respiratory harm remained un- known. /d. From these findings the Secretary determined that the risk of material harm to cottonseed workers would not be “significant” even without a PEL, so long as medical surveillance was retained as a “backstop.” The backstop mechanism would protect hypersensitive workers and safeguard against risks stemming from the current in- ability to pinpoint the exact link between cotton dust and serious respiratory ailments. Jd. at 51,135-36. Finding the facilities and personnel necessary for medical sur- veillance to be available at a cost that appeared trivial in relation to the industry’s gross revenues, the Secretary concluded that medical surveillance was technologically and economically feasible and required it. /d. at 51,171. B. Significant Risk ~ NCPA alleges that the Secretary’s failure to find that the current level of dust in cottonseed mills presents a signficant risk to workers’ health precludes him, under Benzene, from imposing any § 6(b) standard, including one limited to medical surveillance. We disagree; an un- usually precise dictum in Benzene applies to this case and sanctions the Secretary’s determination. In Benzene, the Court reviewed an OSHA regulation reducing the PEL for benzene from 10 parts per million (ppm) to one ppm. In lowering the standard OSHA 5a never adduced any evidence that exposures at 10 ppm presented a risk to workers. Rather, OSHA took the position that it was entitled (and possibly obligated) to lower the PEL to the maximum extent feasible simply because benzene was a carcinogen for which no level of exposure had been proven absolutely harmless. Benzene, 448 U.S. at 652, 100 S.Ct. at 2869. Under OSHA’s in- terpretation of the law, this regulatory power would be constrained only if industry established, apparently “‘be- yond a shadow of a doubt,” that there was a safe level of exposure. Id. The Court strongly rejected the notion that OSHA is entitled to regulate any risk, no matter how small or speculative, to the limits of feasibility. The OSH Act, the Court held, empowers OSHA to regulate only hazards presenting a “significant risk” of material harm to work- ers’ health.' Thus, before OSHA could reduce the exist- ing PEL, it had “the burden .. . 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 impair- ment.” Jd. at 653, 100 S.Ct. at 2869. Here OSHA found that abandoning both the 1000 ug/m* and the 500 ug/m* PELs would not leave workers exposed to a significant risk. Accordingly, NCPA con- tends that under Benzene OSHA may issue no regulatory restrictions at all. We believe, however, that Benzene dictates a significant risk analysis for monitoring re- quirements considerably laxer than for other workplace standards. 1 In a subsequent decision the Court held that once the risk posed by a toxic substance is determined to be significant, the Act com- pels OSHA to adopt regulations providing workers the maximum protection feasible, and does not permit OSHA to engage in cost- benefit analysis. American Textile Manufacturers Institute v. Don- ovan, 452 U.S. 490, 101 S.Ct. 2478, 69 L.Ed.2d 185 (1981). 6a The Benzene Court considered the possibility that OSHA might impose a standard but remain uncertain whether the residual risk was significant. It made clear that OSHA could in such a ease impose monitoring re- quirements as a “backstop,” in order to (1) check the validity of its assumptions in imposing the standard se- lected, (2) develop a sound evidentiary basis for decreas- ing the limit if it proved to have been set too high, and (3) ensure that unusually susceptible workers could be removed from exposure before they suffered permanent damage. 448 U.S. at 657-58, 100 S.Ct. at 2871-72. NCPA appears to acknowledge that this discussion is to be taken seriously despite its technical status as dic- tum. It claims, however, that the statement is applicable only if (1) the substance is toxic and “at some reason- ably attainable level” causes harm, and (2) there is a relationship between worker exposure and health effects (a “dose-response” relationship). The Court’s discussion does not impose either of these conditions, but we take NCPA in essence to argue that the Court’s approval of monitoring would be senseless otherwise: why monitor if there is no chance of harm at levels that may come about? We think the evidence of risk before OSHA justifies application of the Court’s dictum. In assessing whether harm exists at any “reasonably attainable” level, OSHA is hampered by the ambiguous relation between reality and the pre-existing regulation. Although it is agreed that the industry has not complied with the 1000 ug/m* standard (nor a fortiori that of 500 ug/m*), see 50 Fed.Reg. 51,133 and 48 Fed.Reg. 26,968, there is no concession that the regulations of the past 16 years have been absolutely without effect. See 50 Fed.Reg. 51,133, 51,1386; 48 Fed.Reg. 26,968; 43 Fed. Reg. 27,381; see also Joint Appendix (“J.A.”) at 311 (study finding that only two of 18 mills had mean ex- posures greater than 1000 ug/m*). Accordingly, OSHA could fairly infer that removal of the existing PEL (and 7a cancellation of the abortive one of 500 ug/m*) could lead to higher levels of exposure, to the detriment of workers’ health. The record indicates that even the levels of exposure prevailing with the standard in effect pose some risk to workers’ health. For example, a recent National Institute for Occupational Safety and Health (“NIOSH’’) test that is heavily relied upon by all parties found that al- though cottonseed workers did not experience increased incidence of byssinosis, as a group they suffered from decreased lung functions; the smokers among them were afflicted with chronic coughs. Respiratory Disorders and Dust Exposure in Sectors of the Cotton Industry of the United States. Part 3: Cottonseed Oil Mills v, J.A. at 307, 311. The series of studies by the Tulane Group reached similar conclusions, Jones, Hammond, Butcher & Weil, Respiratory Health in Cottonseed Crushing Mills, J.A. at 263-66, and also indicated that 52% of the work- ers studied were current smokers, 20% were ex-smckers, and 15% had allergies, id., J.A. at 264-65. The health organizations and physicians testifying on record over- whelmingly felt that medical surveillance was necessary. E.g., J.A. at 311 (NIOSH), 968-70 (Dr. Jones of Tulane Group), 978 (Dr. Merchant), 987 (Dr. Engleberg). (In- deed, with one prominent exception, Dr. Jones, they rec- ommended that a PEL be retained. ) While it is true that no dose-response relation can be affirmatively established under conditions of American cottonseed processing, 50 Fed.Reg. 51,135, broader evi- dence supports its existence. Foreign cottonseed workers, who are subject to markedly higher doses than American ones, evidently suffer significant health effects. See, e.g., Noweir, El-Sadeh & El-Dahhahny, Exposure to Dust in the Cottonseed Oil Extraction Industry, 19 Arch. Environ. Health 99 (1969), J.A. at 154 (35 of 110 workers exam- ined in Egyptian cottonseed plants exhibited byssinotic symptoms); Barnes & Simpson, Ventilatory Capacity 8a Changes on Exposure to Cotton Dust, Med. J. of Aus- tralia 897 (May 25, 1968), J.A. at 159 (study under- taken in response to worker complaints of wheezing and tightness of the chest found link to cotton-dust ex- posure). See also 53 Fed.Reg. 51,135. Because of this evidence, OSHA rested its finding of no significant risk on “the assurance that retention of medical surveillance will provide a backstop if that judg- ment is incorrect and this surveillance will protect the health of the employees.” 50 Fed.Reg. 51,136. Of course this cannot turn the finding of no significant risk into its opposite; the agency simply did not find evidence of significant risk. We do take the statement, however, to invoke the conditions suggested by the Supreme Court in Benzene for a backstop monitoring requirement: a find- ing that the “less-than-perfect’’ evidence indicates that there is a real possibility of significant health risks un- der the other aspects of the standard adopted (here, no regulation at all). See Benzene, 448 U.S. at 657-58, 100 S.Ct. at 2871-72. C. Feasibility OSHA’s standards must be technologically and eco- nomically feasible, see, e.g., American Textile Manufac- turers Institute v. Donovan, 452 U.S. at 513 n. 31, 101 2 NCPA argues that this conclusion is impermissibly inconsistent with the Secretary’s determination that other nontextile industries— namely knitting and warehousing—require only a_ longitudinal study as a backstop. As to the knitting industry, however, the link between exposure to dust at present levels and respiratory ailments appears less significant, 50 Fed.Reg. 51,131; J.A. at 408 (NIOSH comments) ; operations are inherently less dusty, 50 Fed.Reg. 51,131; and medical experts were less adamant on the need for medical surveillance, see J.A. at 975-76 (testimony of Dr. Merchant). The data available for the warehousing industry were largely inconclu- sive, 50 Fed.Reg. 51,139; J.A. at 975-76 (testimony of Dr. Mer- chant); and work areas in that industry tend to be open with sub- stantial natural ventilation, 50 Fed.Reg. 51,139. 9a S.Ct. at 2492 n. 31; NCPA contends that the medical sur- veillance requirements are neither. The standard requires that cottonseed workers be given an initial examination and follow-up examinations every two years thereafter if the employee manifests no signs of respiratory problems and every six months if he does. 29 C.F.R. § 1910.1043(h) (2), (3) (1986). Each exam- ination involves the compilation or updating of the sub- ject’s medical history, the completion of a standardized questionnaire, and a pulmonary function test. A licensed physician must supervise the program (but need not conduct all facets of the examination in person, id. § 1910.1043(h)(1)). The physician must also issue an opinion summarizing the results of the examination, stat- ing whether the employee has any medical conditions which would place him at increased risk of health im- pairment from exposure to cotton dust, and recommend- ing limitations to be placed on the employee’s exposure. Id. § 1910.1043(h) (5). NCPA finds technological infeasibility in OSHA’s fail- ure to establish that the consulting services, local clinics, and in-shop medical centers expected to conduct the ex- aminations are currently in place and ready to serve. Of course, this deficiency is overwhelmingly likely; re- sources are unlikely to be allocated to such an activity until the requirement attracts them there. Accordingly, it is no surprise that the law requires OSHA to demon- strate only that it is reasonable to expect that such “tech- nology”’ will develop in response to the standard’s promul- gation. United Steelworkers v. Marshall, 647 F.2d 1189, 1264-65 (D.C. Cir.1980), cert. denied, 453 U.S. 913, 101 S.Ct. 3148, 69 L.Ed.2d 997 (1981). As NCPA suggests no reason to suppose that it will not develop, the sole question is whether compliance with the standard is eco- nomically feasible. See id. We have indicated that a standard is economically feasible if the cost of compliance does not threaten the 10a “competitive structure or posture” of the industry. /n- dustrial Union Department v. Hodgson, 499 F.2d 467, 478 (D.C.Cir.1974); see also United Steelworkers, 647 F.2d at 1264-65. Thus if compliance were likely to dis- able the industry from competing with substitute prod- ucts, or markedly to increase concentration within the in- dustry, a finding of infeasibility would be appropriate. See Industrial Union, 499 F.2d at 478. OSHA estimated the total cost of complying with the standard at $70,671. Comparing this estimate to the in- dustry’s annual gross revenues of $777.6 million, OSHA concluded that imposition of the standard was economi- cally feasible. Even for evaluating the industry’s overall prospects for survival, the method is a crude one. If demand for indus- try products were highiy price elastic, a very small price increase could force closure of a substantial segment of the industry. Nonetheless, on the hypothesis that very high price elasticities are rare, it is surely appropriate for OSHA to infer that a cost amounting to a tiny frac- tion of gross revenues (on OSHA’s estimates, less than .01°) will not force a material segment of the industry out of business. NCPA accepts the general approach, but offers some complaints about OSHA’s figures. OSHA’s cost estimate of $70,671 is based on an average cost per examination of $79. In deriving this figure, OSHA started with the median estimated cost per examination identified by an NCPA survey of 36 cottonseed mills, $60, a figure con- sistent with all other estimates on record. See 50 Fed. Reg. 51,170. Reliance on a median estimate might often be misleading in assessing a standard’s impact on indus- try structure. It might, for example, conceal a significant group of firms laboring under a special disability and likely to fail as a result of enforcement. NCPA indeed contends that such a group exists—small firms located lla far from suitable testing spots. In fact, however, NCPA’s own data, submitted to OSHA as part of the rulemaking proceeding, show no significant link between above-median estimated examination costs and firm size or remoteness. See J.A. at 640-41. Further, the record contains some evidence that the highest cost estimates might be reduced in practice. See J.A. at 165. On these facts, accordingly, we are not persuaded that OSHA’s focus on median fig- ures caused it to overlook a likely impact on competitive structure. OSHA then increased its base estimate by adding $15 (three hours at $5 hour“) to account for lost production and $4 to cover transportation costs,‘ yielding a total cost per examination of $79. 50 Fed.Reg. 51,170-71. It then multiplied by 817, the number of jobs in the industry, reflecting an assumption that there would be an annual “new hire” for every job. This produced $64,543, to which OSHA added the cost of retesting those workers that re- mained employed in the industry for two years and arrived at the $70,671 total figure. With the minor excep- tion noted below, OSHA has accounted for every element of expense likely to flow from its standard. NCPA notes correctly that OSHA’s cost estimate omits the cost of providing follow-up examinations every six months to workers who manifest symptoms of respiratory problems. As hypersensitive workers are a major reason for requiring medical surveillance, it was clear error for OSHA to have ignored these costs. Nonetheless, we find the error harmless. See Greater Boston Television Corp. v. F.C.C., 444 F.2d 841, 851 (D.C.Cir.1970), cert. denied, * Cottonseed workers reportedly earn minimum wage. 50 Fed. Reg. 51,171. ‘This results in some double counting as the NCPA estimates from which OSHA derives its base estimate already factor in transportation costs. J.A. at 630. 12a 403 U.S. 923, 91 S.Ct. 2229, 29 L.Ed.2d 701 (1971). Given the industry’s high turnover rate, only a fraction of these workers will actually require a follow-up exam. More- over, if employers implement physicians’ recommenda- tions to place hypersensitive workers in less dusty jobs, symptoms of respiratory ailments should decline, alleviat- ing the need for future follow-up exams. We see no rea- son to believe that OSHA’s error on this point could have had more than a trivial effect on the cost of compliance relative to the industry’s total revenues. II. 3M PETITION OSHA’s regulations place ceilings on cotton dust con- centrations to which workers may be exposed. See, ¢.g., 29 C.F.R. § 1910.1043(¢e) (1) (i) (1986) (limiting cotton dust exposure to 200 ug/m* in yarn manufacturing and cotton washing operations). If worker exposure exceeds the OSHA decreed PEL, or if employees wish to reduce their exposure below the PEL, the employer is obliged to furnish respirators. Jd. § 1910.1043(f) (1). Two factors together determine respirator effectiveness: filter effi- ciency and the “fit factor,” 7.e., the extent to which leak- age occurs between the respirator face and seal and the wearer’s face. OSHA’s effectiveness ratings (or “protection factors’) are tied to particular respirator styles. See id. § 1910.1043 (f) (“supplied air respirators’ have a rating of ten; “high efficiency particulate filter respirators with a full facepiece” have a rating of fifty). The protection factor indicates OSHA’s estimate of the amount of cotton dust filtered. The higher the number, the more successful the filter; a rating of ten means only one of ten dust particles is not filtered. Thus, a respirator with a protection fac- tor of ten will permit work in environments laden with cotton dust concentrations up to ten times the PEL. eeeeEEe—eeenn 13a In 1978, OSHA adopted a protection factor of five for “single-use respirators.” ° The absence of a reliable test for proper fit, not filter efficiency, accounted for the low rating. See 43 Fed.Reg. 27,386 (1978).° This 1978 rat- ing was not challenged in court. Between 1978 and 1983, 3M and other respirator pro- ducers developed a “disposable respirator” similar in con- struction (material and dimensional characteristics) to the single-use respirator.? On the basis of filter efficiency, NIOSH rated this respirator at ten. With no guideline in the 1978 OSHA regulations explicitly covering the newly developed disposable respirators, the cotton industry ap- parently treated them as having a protection factor of ten. During its review of the cotton dust regulations be- tween 1983 and 1985, OSHA concluded that testing for snug fit on a daily basis remained infeasible for any 5 A single-use respirator is similar in shape to, but more rigid than, a surgical mask. Unlike gas-mask style respirators that have air intake and exhale valves, the entire surface area of the single- use respirator is the filter. ®* Using a gas-mask style respirator, the wearer can easily block the air flow valves, breathe deeply, and determine whether air is escaping from the face seal. For the single-use respirator, how- ever, it is difficult, if not impossible, for the wearer to cover the entire surface area, but not the seal between the respirator and the wearer's face. Alternative tests for proper fit that do not require blocking air intake (i.e., spraying into the air a test agent in- capable of penetrating the respirator filter and seeing if the wearer can detect that agent’s distinctive odor, taste or irritation) were unavailable in 1978 for the single-use respirator because all known test agents permeated its filter element. 7 According to comments 3M made to OSHA, the sole notable difference between the 1978 single-use respirator and the 198% disposable respirator is filter efficiency. J.A. at 626-27. For both types, because the filter is inseparable from the respirator, when the filter clogs with dust, making breathing difficult, the entire respirator is thrown away. In its 1985 rule, OSHA classified as disposable all respirators with inseparable filters. l4a respirator constructed like the single-use respirator, ‘e., one in which the filter constitutes the entire surface area of the respirator. Finding no justification for treating single-use and later developed disposable respirators dif- ferently, the agency rated both at five. 3M urges that OSHA acted arbitrarily in refusing to set the effective- ness rating for disposable respirators at ten. A. Standing OSHA asserts initially that 3M lacks standing to peti- tion for review. FAIC Securities, Inc. v. United States, 768 F.2d 352 (D.C.Cir.1985), appears to us dispositive of this threshold issue. Under that decision’s analysis, 3M is a proper petitioner for judicial review. In FAIC Securities, a deposit broker® and a national trade association whose members include deposit brokers successfully challenged as unlawful certain Federal Home Loan Bank Board and Federal Deposit Insurance Cor- poration regulations. The regulations in question altered federal insurance coverage of $100,000 per depositor, per financial institution by adding this qualification: in the case of funds deposited by or through a deposit broker, insurance coverage would be limited to $100,000 per bro- ker, per financial institution. The deposit brokers alleged that the challenged regulations contravened the Federal Deposit Insurance Act (“FDIA”’) and the National Hous- ing Act (“NHA”). They would be put out of business by the altered regulations, the brokers remonstrated, and their customers consequently would be deprived of the S OSHA recognized the availability by 1983 of a new test agent that would not permeate the single-use respirator’s filter element. Cf. supra note 6. OSHA explained, however, that this test, the saccharin QLET, developed for use’ at intervals ef several months, was too time-consuming to be used on a daily basis. 50 Fed.Reg. 51,154 (1985). ® A deposit broker assists investors in placing deposits advan- tageously. See FAIC Securities, 768 F.2d at 355. l5a benefits of placing deposits through a broker. The Federal Home Loan Bank Board, as defendant-appellant in FAIC Securities, contested the brokers’ standing; the Board argued that the brokers failed the prudential “zone of interest” test announced in Association of Data Processing Service Org., Inc. v. Camp, 397 U.S. 150, 156, 90 S.Ct. 827, 831, 25 L.Ed.2d 184 (1970),"° because “‘[t]he NHA and the FDIA are intended to protect the security of depositors, banks and thrifts, not the profits of deposit brokers.’” FAIC Securities, 768 F.2d at 356 (quoting Brief for Appellant Bank Board at 52). Writing for the court in FAIC Securities, then Judge (now Justice) Scalia endeavored to analyze coherently “the confused field of jus tertii standing.” Jd. at 360. He concluded that, under current Supreme Court precedent, notably City of Revere v. Mass. Gen. Hosp., 463 U.S. 239, 103 S.Ct. 2979, 77 L.Ed.2d 605 (1983), Carey v. Popula- tion Services Int'l, 431 U.S. 678, 97 S.Ct. 2010, 52 L.Ed.2d 675 (1977), and Craig v. Boren, 429 U.S. 190, 97 S.Ct. 451, 50 L.Ed.2d 397 (1976), vendors could meet the pru- dential requirement even if they did not independently fulfill the “zone” test; it would do for this purpose if their customers or potential customers passed the test. FAIC Securities, 768 F.2d at 358. The depositors, all agreed, fit within the protective zone of the NHA and FDIA, and the broker-depositor relation- ship fit the vendor-vendee description. Supreme Court decisions, Judge Scalia observed, treat the interests of 1°The Supreme Court addressed the “zone” test most recently in Clarke v. Securities Indus. Ass'n, ——- U.S. ——, 107 S.Ct. 750, 93 L.Ed.2d 757 (1987), and there observed that “[t]he test is not meant to be especially demanding; in particular, there need be no indication of congressional purpose to benefit the would-be plain- tiff.” Jd. at 757 (footnote omitted); see also id. at 757 n. 15 (dis- approving as excessively demanding this court’s formulation of the zone test in Control Data Corp. v. Baldrige, 655 F.2d 283, 293-94 (D.C.Cir.), cert. denied, 454 U.S. 881, 102 S.Ct. 368, 70 L.Ed.2d 190 (1981) ). l6a vendors and vendees as “two sides of the same eoin.” Id. at 359. High Court precedent, he determined, allows vendors to base their standing on their relationship to vendees. and to assert the interest of those vendees, even if no impediment exists to a suit by the vendees them- selves. Id. at 360-61; see Block v. Meese, 793 F 2d 1303. 1309 (D.C.Cir.1986) (citing with approval the analysis in FAIC Securities) In a more recent decision, Haitian Refugee Center v. Gracey, 809 F.2d 794, 811 & n.15 (D.C.Cir.1987), a di- vided panel questioned the reasoning, although not the result, in FAIC Securities. Judge Bork, writing for him- self and Judge Buckley in Haitian Refugee Center, thought the analysis in FAIC Securities flawed because Judge Scalia’s opinion did not advert to the Supreme Court’s decisions in United States v. Payner, 447 U.S. 727. 100 S.Ct. 2439, 65 L.Ed.2d 468 (1980), and Cali- fornia Bankers Ass’n v. Shultz, 416 U.S. 21, 94 S.Ct. 1494, 39 L.Ed.2d 812 (1974). See Haitian Refugee Cen- ter, 809 F.2d at 811. Payner rejected third party invocation of the exclusion- ary rule. The decision rests on fourth amendment, not standing law, analysis. See Rakas v. Illinois, 439 U.S. 128. 132-38. 99 S.Ct. 421, 424-28, 58 L.Ed.2d 387 (1978); United States v. Salvucci, 448 U.S. 83, 87 n.4, 100 8.Ct. 9547, 2551 n.4, 65 L.Ed.2d 619 (1980) (“In Rakas, this Court discarded reliance on concepts of ‘standing’ in de- termining whether a defendant is entitled to claim the protections of the exclusionary rule. The inquiry, after Rakas, is simply whether the defendant’s rights were vio- lated by the allegedly illegal search or seizure.”). Rakas explained that the exclusionary rule is but one form of remedy afforded for fourth amendment violations; denial of this remedy to those invoking the fourth amendment rights of others, the Court reasoned, was appropriate in view of the “substantial social cost [of keeping] |[r]ele- vant and reliable evidence . . . from the trier of fact and 17a deflecting] the search for truth at trial.” 439 U.S. 128, 134, 137, 99 S.Ct. 421, 425, 427, 58 L.Ed.2d 387 (1978). Cf. Rohr, Fighting for the Rights of Others: The Trou- bled Law of Third-Party Standing and Mootness in the Federal Courts, 35 U. Miami L.Rev. 398, 459-61 (1981) ‘litigant is generally not positioned to seek damages for violation of a third person’s rights). California Bankers Ass’n also involved a fourth amendment challenge.'' Moreover, even if one read that less than crystalline 1974 decision to deny that a vendor- vendee relationship is enough to permit third-party standing, pre-1976 High Court precedent, as Judge Scalia pointed out, has been overtaken by the Court’s later de cisions. See FAIC Securities, 768 F.2d at 359. The discussion of FAIC Securities in Haitian Refugee Center was both brief and unessential to the majority’s decision.'* The suggestion that Payner and California Bankers Ass’n undermine the reasoning in FAIC Securi- ties does not appear compelling in light of the special fourth amendment contexts in which those two Supreme Court dispositions are embedded. See Monaghan, Third Party Standing, 84 Colum.L.Rev. 277, 279 n. 9, 292 n. 11In California Bankers Ass’n, the Court first concluded that all litigating bank depositors lacked standing, then declined to per- mit a bank or banking association to assert the rights of any depositor. 416 U.S. at 69, 94 S.Ct. at 1521. The Haitian Refugee Center majority opinion suggests that the Court in California Bankers Ass'n denied the banks standing despite the direct im- pact of the challenged Treasury regulation on many bank customers; the Solicitor General’s brief in California Bankers, however, sug- gested that depositors affected by the regulation in question were not so common as to make their business with the plaintiff banks predictable. Compare Haitian Refugee Center, 809 F.2d at 809, with Brief for the Appellants, California Bankers Ass’n v. Shultz, 416 U.S. 21, 94 S.Ct. 1494, 39 L.Ed.2d 812 (1974). 12 The Center, seeking to assist Haitian refugees settle in the United States, was not in a vendor-vendee relationship with the interdicted Haitians whose interests the Center sought to advance. 18a 88, 305 n. 149 (1984) ; see also Rohr, supra, 35 U. Miami L.Rev. at 461 n. 290 {case law shows uniquely firm denial of third-party standing to invoke the ‘“exclusion- ary rule” of criminal procedure). We therefore conclude that FAIC Securities continues to state law of the cir- cuit, binding upon us unless and until changed by the court sitting en bane, or shown to be incorrect by in- struction from Higher Authority.’ If the FAIC Securi- ties deposit brokers’ and depositors’ interests are “two sides of the same coin,” 768 F.2d at 359, so too are 3M’s interest in selling the disposable respirators it manu- factures, and cotton processing plant operators’ interest in purchasing the respirators. If the brokers had stand- ing in FAIC Securities, then 3M has standing here; no tenable distinction can be drawn between the relation- ship of the litigant and third party in the two cases. 13 Even under Haitian Refugee Center’s view of FAIC Securities, we note, 3M would appear to have standing in this case. Haitian Refugee Center observes that litigants may challenge, pursuant to their own right not to be injured by unauthorized agency action, any regulation allegedly ultra vires the statutes administered by the agency. 809 F.2d at 811 n. 13. 3M complains that OSHA’s allegedly excessive regulation of disposable respirators passes be- yond the authority afforded OSHA in the OSH Act. 29 U.S.C. § 651 et seq. Just as Haitian Refugee Center recognized the stand- ing of the deposit brokers in FAIC Securities to sue in their own right, so Haitian Refugee Center would seem to tolerate 3M’s stand- ing to sue in its own right. 14 The decisions principally relied upon by OSHA, R.T. Vander- bilt Co. v. Occ. Saf. & H. Rev. Comm’n, 708 F.2d 570 (11th Cir. 1983), and Fire Equipment Mfrs. Ass'n, Inc. v. Marshall, 679 F.2d 679 (7th Cir.1982), cert. denied, 459 U.S. 1105, 103 S.Ct. 728, 74 L.Ed.2d 953 (1983), hold that the right of product manufacturers to deal with their customers falls outside the zone of interest of the OSH Act. Neither decision considered the product manufac- turer’s opportunity to rely on the interest of its customers to fit within the zone. Fire Equipment Mfrs. did consider third-party standing, but only in the context of employers’ ability to assert employee rights and, arguably, of product manufacturers to assert the rights of customers’ employees. 19a Following FAIC Securities, we are constrained to recog- nize 3M’s standing on the basis of “the vendor-vendee relationship alone.” Jd. at 361." B. Merits 3M features three bases for declaring arbitrary OSHA’s assignment, in its cotton dust regulations, of a protection factor of only five to disposable respirators. First, 3M asserts that feasible tests of proper fit, if un- available in 1978, are available now. Second, 3M points to the higher (ten) rating accorded disposable respira- tors by national standard-setting organizations. Third, and most weighty in 3M’s presentation, OSHA itself, in standards the agency adopted for the lead industry in 1982, approved establishment of a protection factor of ten for disposable respirators. We examine each 3M position in turn. Two procedures, the saccharin QLFT' and the posi- tive pressure fit check (PPFC),'* 3M states, are avail- able to test disposable respirators for face-fit; each, 3M 1 Judge Scalia noted the “admirable effort to bring coherence to the vendor-vendee cases” in Monaghan, Third Party Standing, 84 Colum.L.Rev. 277 (1984) (cited in FAIC Securities, 768 F.2d at 360 n. 5). Professor Monaghan observed that the Supreme Court has never limited a litigant’s standing to cases in which the com- plainant (rather than a third party) is the subject of government regulations. Jd. at 302-03 nn. 138-40 (citing, i.e., Pierce v. Soc’y of Sisters, 268 U.S. 510, 45 S.Ct. 571, 69 L.Ed. 1070 (1925); Buchanan v. Warley, 245 U.S. 60, 38 S.Ct. 16, 62 L.Ed. 149 (1917); Truax v. Raich, 239 U.S. 33, 36 S.Ct. 7, 60 L.Ed. 131 (1915) ). '®To take the saccharin QLFT test, the subject puts on the respirator and breathes normally. A saccharin aerosol is sprayed near the subject. Because the aerosol cannot penetrate the dispos- able respirator filter, if the subject tastes the sweet saccharin, the respirator fits improperly. 17 The PPFC procedure requires the test subject to cover with his hands the portion of the respirator intended to permit air intake. If, on inhaling, the subject gets no air, the respirator fits properly. 20a contends, is independently adequate to do the job. If 3M were right about the adequacy of these tests, we would be obliged to rule in its favor; the sole reason OSHA gave for rating disposable respirators at five rather than ten is the inability of the cotton plant op- erator and worker to check reliably for proper fit. OSHA acknowledges that the saccharin QLFT will detect improper fit. But the test is not proffered by 3M as one the plant operator will employ for each worker each day. As 3M conceded at oral argument, the saccha- rin test is intended for use every three or six months; the test, administered at these intervals, checks for altera- tion in a wearer’s facial contours that might affect the fit of the respirator. OSHA observed that “it is not appropriate to require the employers to conduct the sac- charin QLFT each time the respirator is worn since it is time consuming. .. .” 50 Fed.Reg. 51,154 (1985). Unsurprisingly, 3M does not press for such a require- ment, one likely to increase the cost, and reduce the at- tractiveness, of its product to employers. The PPFC procedure is an effective daily check for the fit of a gas-mask style respirator. Respirators of that type confine intended air intake to valves that can be blocked off easily by the employee’s hands. By con- trast, the entire surface of a disposable respirator is intended to permit air intake. OSHA recognized that, in the case of disposable respirators, the worker’s hands cannot effectively block intended air intake, and that in- take only, while leaving unobstructed air taken in be- cause of the respirator’s improper fit. See supra note 6.'* We think it evident that OSHA did not rule without 153M referred to a study it had conducted on twenty-three of its employees, purportedly showing that the PPFC will “pass” no one whose disposable respirator fits in a fashion providing actual pro- tection at less than a factor of ten. It suffices to note that the small size of the 3M study justified OSHA’s refusal to count it persuasive. 2la reason when it adhered to the view that no test appro- priate for daily use adequately assured the proper fit for disposable respirators. We consider next 3M’s second point. Both NIOSH and the Committee on Safety Standards for Respiratory Pro- tection of the American National Standards Institute (“ANSI”) have rated disposable respirators at ten. But neither organization took account of respirator fit; both based their ratings on filter performance. Absent assur- ance of a respirator’s proper fit, the NIOSH and ANSI ratings can reliably indicate only the efficiency of the filter, not the effectiveness of the entire respirator as it is used on the job.’"° In 1978, OSHA rated single-use respirators at five because of the considerable risk of undetected leakage when worn at work. See 43 Fed.Reg. 27,386 (1978).°° With no evidence of significant im- provement in a user’s ability to thwart leakage, OSHA continued in force its prior judgment. See 50 Fed.Reg. 51,154 (1985) (“A protection factor of 5 for the class of disposable dust and mist respirators is the appropri- ate protection factor to provide an adequate margin of safety to overcome the fitting problem.”).2' We see no 19 When proper fit can be assured, as in the case of respirators with easily blocked air-intake valves, the NIOSH and ANSI stand- ards present a fair assessment of respirator effectiveness as well as filter efficiency. Thus, OSHA’s adoption of ANSI ratings for some respirators, but not for disposable respirators, seems entirely rational. 203M suggests that OSHA was wrong in 1978 when it concluded that single-use respirators could not achieve protection warrant- ing a rating of ten. Time for that challenge has long since passed. See 29 U.S.C. § 655(f). We do not understand 3M to contend that this court should review the 1978 evidence in its consideration of the rulemaking completed in 1985. See Brief for Petitioner [ Min- nesota Mining and Manufacturing] at 26-28. 212M does not suggest that improved filter efficiency alone war- rants treating its disposable respirator differently from the single- use respirator OSHA dealt with in 1978. 22a necessity for change based on ratings of filters rather than disposable respirators in their entirety. Finally, we evaluate the challenge to which 3M at- taches greatest weight. While disposable respirators are rated at five for use in the cotton industry, the very same respirators can be rated at ten in the lead industry, 3M emphasizes. OSHA explains that this disparate treatment is attributable primarily to differences in the effectiveness of medical screening in the two industries. Medical screening for lead adequately substitutes for daily fit testing, OSHA maintains, but medical screen- ing for lung diseases from cotton dust does not. Cf. 51 Fed.Reg. 22,735 (1986) (to be codified at 29 C.F.R. § 1910.1001(g)(2)) (disposable respirators declared in- adequate, hence unusable, as a means of affording any protection against exposure to asbestos). Blood lead tests provide an immediate and direct indi- cation of the presence of lead in a worker’s body. Al- though the source of the lead detected (for example, whether it was inhaled as a result of an improperly fitted respirator) is not identifiable, a worker can be safe- guarded promptly. He can be supplied with a gas-mask style respirator or removed from a lead-laden environ- ment immediately upon screening, before adverse health effects develop. Workers in the lead industry are tested at six month intervals. OSHA determined that six months’ exposure to lead between blood tests presents an acceptable health risk, and we have no reason, on the record before us, to question that determination. Be- cause of the efficacy of monitoring blood-levels, OSHA found it suitable to allow disposable respirators, when used in the lead industry, a protection factor rating of ten. By contrast, current medical screening of workers is incapable of detecting cotton dust inhalation immediately and unmistakably. Medical tests in the cotton industry 23a rely, in part, on worker identification of symptoms. The administrative record here suggests that workers do not always acknowledge the presence of symptoms. J.A. at 49, 187. Further, the tests detect only actual lung impairment. Medical screening does not isolate cot- ton dust from other airborne contaminants that cause lung impairment; more significantly, medical tests expose the potential presence of a contaminant only by detect- ing actual adverse health effects. The administrative re- cord does indicate that early manifestations of lung im- pairment are reversible. At least some health impair- ment, however, even if curable, develops before a cotton worker furnished with a disposable respirator can be in- formed of her plight through medical screening, and thus be alerted to the need to substitute a gas-mask style respirator or to transfer to a work station away from dusty areas.” OSHA, we conclude, has adequately accounted for its position. We cannot set aside as irrational that expert agency’s determination that the precision of medical test- ing for lead in comparison to the imprecision of testing for cotton dust inhalation warrants the differential rat- ing of disposable respirators in the two industries. CONCLUSION For the reasons stated, the petitions for review are denied and the challenged regulations are affirmed. It is so ordered. *2 The cotton dust regulations, we note, require screening every one or two years for most workers, and every six months only for workers identified as already suffering from lung impairment. 29 C.F.R. § 1910.1043(h)(3) (1986). OSHA might have required more frequent medical screening, but 3M’s plea does not demonstrate that the agency’s decision to rate disposable respirators at five and continue the existing screening schedule indicates an impermissible choice between the competing interests and costs at stake. 24a APPENDIX B UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT No. 78-2014 NATIONAL COTTONSEED PRODUCTS ASSOCIATION, . Petitioner WILLIAM FE. Brock, Secretary of Labor, United States Department of Labor and EULA BINGHAM, Assistant Secretary of Labor, United States Department of Labor; OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, United States Department of Labor, Respondents No. 86-1075 NATIONAL COTTONSEED PRODUCTS ASSOCIATION, Petitioner v. WILLIAM E. Brock, Secretary of Labor, U.S. Department of Labor, et al., Respondents No. 86-1157 MINNESOTA MINING AND MANUFACTURING COMPANY, .. Petitioner OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, et al., Respondents 25a Petitions fur Review of Orders of the Occupational Safety and Health Administration [Filed Aug. 7, 1987] Before: ROBINSON, RUTH B. GINSBURG and WILLIAMS, Circuit Judges. These causes came on to be heard on the petitions for review of orders of the Occupational Safety and Health Administration, and were argued by counsel. On consid- eration thereof, it is ORDERED and ADJUDGED, by this Court, that the petitions for review are denied and the challenged regula- tions are affirmed, in accordance with the Opinion for the Court filed herein this date. Per Curiam For The Court s/ George A. Fisher GEORGE A. FISHER Clerk Date: August 7, 1987 Opinion for the Court filed by Circuit Judge Ruth B. Ginsburg and Circuit Judge Williams. 26a APPENDIX C UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT No. 78-2014 NATIONAL COTTONSEED PRODUCTS ASSOCIATION We WILLIAM E. Brock, Secretary of Labor, et al. And Consolidated Cases | Filed Oct. 23, 1987 | Before: ROBINSON, RUTH B. GINSBURG and WILLIAMS, Circuit Judges ORDER Upon consideration of petitioner’s petition for rehear- ing, it is ORDERED, by the Court, that the petition is denied. Per Curiam FOR THE COURT: GEORGE A. FISHER Clerk By: /s’ Robert A. Bonner ROBERT A. BONNER Deputy Clerk 27a UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT No. 78-2014 NATIONAL COTTONSEED PRODUCTS ASSOCIATION Vv. WILLIAM E. Brock, Secretary of Labor, et al. And Consolidated Cases [Filed Oct. 23, 1987] Before: Wald, Chief Judge; Robinson, Mikva, Edwards, Ruth B. Ginsburg, Bork, Starr, Silberman, Buck- ley, Williams, D. H. Ginsburg and Sentelle, Cireuit Judges ORDER Petitioner’s suggestion for rehearing en banc has been circulated to the full Court. No member of the Court requested the taking of a vote thereon. Upon considera- tion of the foregoing, it is ORDERED, by the Court en banc, that the suggestion is denied. Per Curiam FOR THE COURT: GEORGE A. FISHER Clerk By: /s/ Robert A. Bonner ROBERT A. BONNER Deputy Clerk Circuit Judge Sentelle did not participate in this order. 28a APPENDIX D Section 3(8) of the Occupational Safety and Health Act of 1970 (“OSH Act”), 29 U.S.C. § 652(8), provides: The term “occupational safety and health stand- ard” means a standard which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or health- ful employment and places of employment. Section 6(b) of the OSH Act, 29 U.S.C. § 655(b), in pertinent part provides: The Secretary may by rule promulgate, modify, or revoke any occupational safety or health stand- ard in the following manner: * “" * * (5) 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 feas- ible, 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. Development of standards under this subsection shall be based upon research, demonstrations, ex- periments, 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. Whenever prac- ticable, the standard promulgated shall be expressed 29a in terms of objective criteria and of the perform- ance desired. * * _ * (7) Any standard promulgated under this sub- section shall prescribe the use of labels or other ap- propriate forms of warning as are necessary to in- sure that employees are apprised of all hazards to which they are exposed, relevant symptoms and ap- propriate emergency treatment, and proper condi- tions and precautions of safe use or exposure. Where appropriate, such standard shall also pre- scribe suitable protective equipment and control or technological procedures to be used in connection with such hazards and shall provide for monitoring or measuring employee exposure at such locations and intervals, and in such manner as may be neces- sary for the protection of employees. In addition, where appropriate, any such standard shall pre- scribe the type and frequency of medical examina- tions or other tests which shall be made available, by the employer or at his cost, to employees exposed to such hazards in order to most effectively deter- mine whether the health of such employees is ad- versely affected by such exposure. In the event such medical examinations are in the nature of research, as determined by the Secretary of Health and Hu- man Services, such examinations may be furnished at the expense of the Secretary of Health and Human Services. The results of such examinations or tests shall be furnished only to the Secretary or the Secretary of Health and Human Services, and, at the request of the employee, to his physician. The Secretary, in consultation with the Secretary of Health and Human Services, may by rule promul- gated pursuant to section 553 of title 5, make ap- propriate modifications in the foregoing require- ments relating to the use of labels or other forms of warning, monitoring or measuring, and medical examinations, as may be warranted by experience, 30a information, or medical or technological develop- ments acquired subsequent to the promulgation of the relevant standard. 29 C.F.R. § 1910.1043, 50 Fed.Reg. 51173 (Dec. 13, 1985), in pertinent part provides: ’ (a) (3) Only paragraphs (h) Medical surveil- lance, (k) (2)-(4) Recordkeeping—Medical Records, and Appendices B, C and D of this section apply in all work places where employees exposed to cotton dust engage in cottonseed processing or waste proc- essing operations. * * * > (h) Medical surveillance—i(1) General. (i) Each employer covered by the standard shall institute a program of medical surveillance for all employees exposed to cotton dust. (ii) The employer shall assure that all medical examinations and procedures are performed by or under the supervision of a licensed physician and are provided without cost to the employee. (ili) Persons other than licensed physicians, who administer the pulmonary function testing required by this section shall have completed a NIOSH- approved training course in spirometry. (2) Initial examinations. The employer shall pro- vide medical surveillance to each employee who is or may be exposed to cotton dust. For new employees, this examination shall be provided prior to initial assignment. The medical surveillance shall include at least the following: (i) A medical history; (ii) The standardized questionnaire contained in Appendix B; and (iii) A pulmonary function measurement, includ- ing a determination of forced vital capacity (FVC) 3la and forced expiratory volume in one second (FEV,), the FEV,/FVC ratio, and the percentage that the measured values of FEV, and FVC differ from the predicted values, using the standard tables in Ap- pendix C. These determinations shall be made for each employee before the employee enters the work- place on the first day of the work week, preceded by at least 35 hours of no exposure to cotton dust. The tests shall be repeated during the shift, no less than 4 and and no more than 10 hours after the beginning of the work shift; and, in any event, no more than one hour after cessation of exposure. Such exposure shall be typical of the employee’s usual workplace exposure. The predicted FVE, and FVC for blacks shall be multiplied by 0.85 to adjust for ethnic dif- ferences. (iv) Based upon the questionnaire results, each employee shall be graded according to Schilling’s byssinosis classification system. (3) Periodic examinations. (i) The employer shall provide at least annual medical surveillance for all employees exposed to cotton dust above the action level in yarn manufacturing, slashing and weaving, cotton washing and waste house operations. The employer shall provide medical surveillance at least every two years for all employees exposed to cotton dust at or below the action level, for all employees exposed to cotton dust from washed cotton (except from washed cotton defined in paragraph (n) (3) of this sectio. ‘, and for all employees exposed to cot- ton dust in cottonseed processing and waste process- ing operations. Periodic medical surveillance shall include at least an update of the medical history, standardized questionnaire (App. B-111), Schilling byssinosis grade, and the pulmonary function meas- urements in paragraph (h)(2) (iii) of this section. (ii) Medical surveillance as required in paragraph (h) (3) (i) of this section shall be provided every 32a six months for all employees in the following cate- gories: (A) An FEV, of greater than 80 percent of the predicted value, but with an FEV, decrement of 5 percent or 200 ml. on a first working day; (B) An FEV, of less than 80 percent of the pre- dicted value; or (C) Where, in the opinion of the physician, any significant change in questionnaire findings, pul- monary iunction results, or other diagnostic tests have occurred. (iii) An employee whose FEV, is less than 60 per- cent of the predicted value shall be referred to a physician for a detailed pulmonary examination. (iv) A comparison shall be made between the cur- rent examination results and those of previous exami- nations and a determination made by the physician as to whether there has been a significant change. (4) Information provided io the physician. The employer shall provide the following information to the examination [sic] physician: (i) A copy of this regulation and its Appendices; (ii) A description of the affected employee’s duties as they relate to the employee’s exposure; (iii) The employee’s exposure level or anticipated exposure level; (iv) A description of any personal protective equipment used or to be used; and (v) Information from previous medical examina- tions of the affected employee which is not readily available to the examining physician. (5) Physician’s written opinion. (i) The employer shall obtain and furnish the employee with a copy of a written opinion from the examining physician con- taining the following: 83a (A) The results of the medical examination and tests including the FEV,, FVC, AND [sic] FEV,/ FVC ratio; (B) The physician’s opinion as to whether the employee has any detected medical conditions which would place the employee at increased risk of mate- rial impairment of the employee’s health from expo- sure to cotton dust; (C) The physician’s recommended limitations upon the employee’s exposure to cotton dust or upon the employee’s use of the respirators including a deter- mination of whether an employee can wear a negative pressure respirator, and where the employee cannot, a determination of the employee’s ability to wear a powered air purifying respirator; and, (D) A statement that the employee has been informed by the physician of the results of the medical examination and any medical conditions which require further examination or treatment. (ii) The written opinion obtained by the employer shall not reveal specific findings or diagnoses un- related to occupational exposure. * * * * (k) (2) Medical surveillance. (i) The employer shall establish and maintain an accurate medical record for each employee subject to medical surveil- lance required by paragraph (h) of this section. (ii) The record shall include: (A) The name and social security number and description of the duties of the employee; (B) A copy of the medical examination results including the medical history, questionnaire response, results of all tests, and the physician’s recommenda- tion; (C) A copy of the physician’s written opinion; 34a (D) Any employee medical complaints related to exposure to cotton dust; (E) A copy of this standard and its appendices, except that the employer may keep one copy of the standard and appendices in the medical surveillance record of each employee; and (F) A copy of the information provided to the physician as required by paragraph (h) (4) of this section. (iii) The employer shall maintain this record for at least 20 years. (3) Availability. (i) The employer shall make all records required to be maintained by paragraph (k) of this section available to the Assistant Secretary and the Director for examination and copying. (ii) Employee exposure measurement records and employee medical records required by this paragraph shall be provided upon request to employees, desig- nated representatives, and the Assistant Secretary in accordance with 29 CFR 1910.20(a)-(e) and (g)-(i). (4) Transfer of records. (i) Whenever the em- ployer ceases to do business, the successor employer shall receive and retain all records required to be maintained by paragraph (k) of this section. (ii) Whenever the employer ceases to do business, and there is no successor employer to receive and retain the records for the prescribed period, these records shall be transmitted to the Director. (iii) At the expiration of the retention period for the records required to be maintained by this section, the employer shall notify the Director at least 3 menths prior to the disposal of such records and shall transmit those records to the Director if the Director requests them within that period. (iv) The employer shall also comply with any additional requirements involving transfer of records set forth in 29 CFR 1910.20(h). --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385019_1242%3A1. Public record. Not legal advice.