# Petition for Writ of Certiorari — American Dental Ass'n v. Reich > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386019_1085%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition for Writ of Certiorari - **Published:** January 1, 1993 - **Citation:** 510 U.S. 859 ## Text » Bpreme Court, U.S (FTL EDN No. _ JUN 9 8 1993 ‘ DFFICE UF THE CLERK IN THE Supreme Court of the United States OCTOBER TERM, 1992 AMERICAN DENTAL ASSOCIATION, Petitioner, Vv. ROBERT REICH, SECRETARY OF LABOR, et al., Respondents. Petition for a Writ of Certiorari to the United States Court of Appeals for the Seventh Circuit PETITION FOR A WRIT OF CERTIORARI Of Counsel: W. ScoTT RAILTON * Mary K. LOGAN JOHN F. DIENELT General Counsel and CHRISTOPHER L. KILLION Assistant Executive REBECCA R. BURKHOLDER Director, Division of REED SMITH SHAW & MCCLAY Legal Affairs 1200 18th Street, N.W. KATHLEEN M. Topp Washington, D.C. 20036 Associate General Counsel (202) 457-6100 AMERICAN DENTAL Counsel for Petitioner ASSOCIATION American Dental Association 211 E. Chicago Avenue Chicago, IL 60611-2678 (312) 440-2886 * Counsel of Record June 28, 1993 WILSON - EPES PRINTING Co., INC. - 789-0096 - WASHINGTON. D.C. 20001 QUESTIONS PRESENTED FOR REVIEW Section 6(b)(5) of the Occupational Safety and Health Act authorizes the Secretary of Labor to issue standards regulating harmful physical agents in the workplace. Be- fore issuing a standard, the Secretary must make a thresh- old finding that workers are exposed to a significant risk of material health impairment. The standard at issue regulates occupational exposure to a variety of viral agents that may be transmitted by contact with blood or other body fluids. The questions presented are: 1) Whether the Secretary, when adopting a standard concerning a number of harmful physical agents, each of which presents different risks in the disparate industries to which the standard will apply, may assume that the risk is uniform across all industries for the purpose of making the determination that there is a significant risk of material health impairment. 2) Whether the Secretary may ignore more cost- effective alternatives to the standard adopted that would eliminate or substantially reduce the risk to workers. 3) Whether a reviewing court of appeals may defer to the Secretary’s findings, though unsupported by evidence in the record, on the grounds that (a) the Court is un- qualified to pass judgment on the findings, and (b) the regulated industries did not disprove the findings. (i) ii PARTIES TO THE PROCEEDING The parties to case no. 91-3865 below were: the Amer- ican Dental Association, Petitioner; Robert Reich, Secre- tary of Labor,* and the Occupational Safety and Health Administration, Respondents; and the American Feder- ation of State, County and Municipal Employees, AFL- CIO, and Service Employees International Union, AFL- CIO, Intervening Respondents. The parties to consolidated case no. 92-1482 below were: Home Health Services and Staffing Association, Inc., Petitioner; and Robert Reich, Secretary of Labor, and the Occupational Safety and Health Administration, United States Department of Labor, Respondents. The parties before this Court are the same as the parties below. * Pursuant to Fed. R. App. P. 43(c) (1), Robert Reich was sub- stituted as a Respondent upon succeeding Lynn Martin as Secretary of Labor. TABLE OF CONTENTS QUESTIONS PRESENTED FOR REVIEW .............. PARTIES TO THE PROCEEDING |... TABLE OF AUTHORITIES ............0.00.000000.000ccecceeeee ee REASONS FOR GRANTING THE WRIT ............... I. II. III. THE COURT OF APPEALS’ DECISION RAISES IMPORTANT ISSUES CONCERN- ING OSHA’S OBLIGATION TO FIND A SIG- NIFICANT RISK OF HEALTH IMPAIR- MENT BEFORE ISSUING A STANDARD, AND CONFLICTS WITH DECISIONS BY THIS COURT AND OTHER COURTS OF APPEALS ......... JESSE 2 Tp > Pe a THE COURT OF APPEALS’ DECISION RAISES AN IMPORTANT ISSUE CONCERN- ING OSHA’S AUTHORITY TO IGNORE MORE COST-EFFECTIVE ALTERNATIVES TO THE STANDARD ADOPTED .................... THE COURT OF APPEALS’ DECISION CON- FLICTS WITH DECISIONS BY THIS COURT AND OTHER COURTS OF APPEALS CON- CERNING THE BURDEN OF PROOF AND STANDARD OF REVIEW ........ o.oo... I LS 10 10 13 14 17 iv TABLE OF AUTHORITIES Cases Page AFL-CIO v. OSHA, 965 F.2d 962 (11th Cir. _) ER a ED sist cckechcidlanteleatabasentetes eee Crna 11, 12, 16 American Textile Mfrs. Inst. v. Donovan, 452 oe Se th PNP eaten erode n 10, 13, 16 Buildings & Constr. Trades Dep’t, AFL-CIO v. Brock, 838 F.2d 1258 (D.C. Cir. 1988) _.............. 13 Industrial Union Dep’t, AFL-CIO v. American Petroleum Inst., 448 U.S. 607 (1980)... 10,11, 15 International Union, UAW v. OSHA, 938 F.2d 1810 (D.C. Cir. 1991) ............ OE LLANES 11,12 Jacobson v. Massachusetts, 197 U.S. 11 (1905)... 14 Synthetic Organic Chemical Mfrs. Ass’n_ v. Brennan, 503 F.2d 1155 (3d Cir. 1974), cert. denied, 420 U.S. 973 (1975) .........2.222-.2.eeeeeeeee. 16 United Steelworkers of America v. Marshall, 647 F.2d 1189 (DC. Cir. 1980), cert. denied sub nom., Lead Industries Ass’n v. Donovan, 453 te 2) EEA A te nn Pi OT 12, 16 Statutes ee en eas 2 Be a ae I iad enlesc hdc ccuereon vices ocantae bce tae 3, 10, 13 29 U.S.C. § 654 (a) (1) ....... fete oe PNR ASN SA 5 yk Vahey. | | | SRRean Reon tanner rare ATE ante” passim OD Rees ove eet ee ran ee Ree 2,4, 8,16 Pub. L. No. 102-141, 105 Stat. 876, § 633 (1991)... 5 Other Materials 43 Fed. Reg. 27350, 27360-61 (1978) _.......... ee ee 12 Ry BT BRS: | eer ee 4 56 Fed. Reg. 64004 (Dec. 6,1991) ............eee eee. 2 IN THE Supreme Court of the United States OCTOBER TERM, 1992 No. AMERICAN DENTAL ASSOCIATION, Petitioner, Vv. ROBERT REICH, SECRETARY OF LABOR, et al., Respondents. Petition for a Writ of Certiorari to the United States Court of Appeals for the Seventh Circuit PETITION FOR A WRIT OF CERTIORARI The American Dental Association (“ADA”) respect- fully petitions for a writ of certiorari to review the judg- ment and opinion of the United States Court of Appeals for the Seventh Circuit, entered in this proceeding on January 28, 1993. OPINIONS BELOW The Court of Appeals’ opinion is reported at 984 F.2d 823 and is reprinted in the appendix (“App.”) at p. la. 2 The Final Rule on Occupational Exposure to Blood- borne Pathogens, issued by the Occupational Safety and Health Administration (“OSHA”), is reported at 56 Fed. Reg. 64004, 64175 (Dec. 6, 1991). The rule is reprinted in the appendix at p. 53a. JURISDICTION OSHA issued the bloodborne pathogens rule on De- cember 6, 1991 pursuant to section 6(b)(5) of the Occu- pational Safety and Health Act (“OSH Act”), 29 U.S.C. § 655(b) (5). Pursuant to section 6(f) of the OSH Act, 29 U.S.C. S$ 655(f), the ADA petitioned for review of the rule in the Court of Appeals for the Seventh Circuit on Decem- ber 19, 1991. App. 84a. On March 6, 1992, the Seventh Circuit consolidated the ADA’s petition with a petition for review filed by Home Healih Services and Staffing Association, Inc. (“Home Health”). App. 85a. On January 28, 1993, the Seventh Circuit issued an opinion denying the ADA’s petition and denying in part Home Health’s petition. After obtaining an extension of time, App. 86a-87a, Home Health filed a petition for re- hearing and suggestion for rehearing en banc on Febru- ary 25, 1993. On April 6, 1993, the ADA filed in this Court a pro- tective application for extension of time to file a petition for a writ of certiorari. On April 9, Justice Stevens issued an order extending the ADA’s time for filing to June 27, 1993. The Seventh Circuit denied Home Health’s petition for rehearing on May 27, 1993. App. 88a-89a. This Court has jurisdiction to review the judgment of the Seventh Circuit pursuant to 28 U.S.C. § 1254(1). 3 STATUTES INVOLVED 29 U.S.C. § 652. Definitions For the purposes of this chapter— * * * * (8) 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 appro- priate to provide safe or healthful employment and places of employment. 29 U.S.C. § 655. Standards * * * * (b) Procedure for promulgation, modification, or revo- cation of standards The Secretary may by rule promulgate, modify, or revoke any occupational safety or health standard 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 feasible, on the basis of the best available evidence, that no emp!loyee 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. De- velopment of standards under this subsection shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addi- tion to the attainment of the highest degree of health and safety protection for the employee, other considera- tions 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. When- ever practicable, the standard promulgated shall be ex- 4 pressed in terms of objective criteria and of the per- formance desired. (f) Judicial review Any person who may be adversely affected by a stan- dard issued under this section may at any time prior to the sixtieth day after such standard is promulgated file a petition challenging the validity of such standard with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such standard. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary. The filing of such petition shall not, unless otherwise ordered by the court, operate as a stay of the standard. The determinations of the Secre- tary shall be conclusive if supported by substantial evi- dence in the record considered as a whole. STATEMENT OF THE CASE On May 30, 1989, OSHA published a Notice of Pro- posed Rulemaking on occupational exposure to pathogens, such as the hepatitis B virus (“HBV”) and the human immunodeficiency virus (“HIV”), which may be trans- mitted by contact with blood and other body fluids. 54 Fed. Reg. 23042 (1989). The ADA objected to the proposed rule.’ During the rulemaking proceedings, the ADA empha- sized that dental health care workers routinely are ex- posed to saliva, which does not present a significant risk of HBV or HIV transmission. App. 104a. A patient’s saliva may contain some quantity of blood, but the fre- quency and degree of exposures to blood in dental offices are far lower than in other health care settings.” 1QOSHA received over 3,000 comments on the proposed rule, resulting in the largest substantive record in OSHA’s history. The ADA submitted three sets of comments, a post hearing brief, and supplementary information. See Record Ex. 11-43, 20-665, 58, 282, 295. 2 Dental offices are controlled environments; more than 90% of all dental patients are seen by appointment for specific treatment. 5 The ADA also emphasized that the HBV vaccine, which was not available until the early 1980s, virtually eliminates the risk of hepatitis B. Record Ex. 295 at 10. HBV is the only pathogen that OSHA found presents a Significant risk to worker health. App. 92a-93a. In addition, the ADA stressed that the Centers for Disease Control and Prevention (“CDC”) had issued guidelines as early as 1986 for the control of HIV and HBV transmission in health care settings. On August 15, 1988, OSHA instituted a compliance program to enforce the CDC guidelines in health care settings. OSHA used existing regulations and its statutory authority under the “general duty” clause, 29 U.S.C. § 654(a)(1), to enforce the CDC guidelines. In 1991, the CDC issued guidelines for the control of HIV and HBV transmission in ‘“exposure-prone invasive procedures.” Among other things, those guidelines in- structed health care workers to “‘adhere to universal pre- cautions, including the appropriate use of hand washing, protective barriers, and care in the use and disposal of needles and other sharp instruments.” * App. 100a-102a. The guidelines state that exposure-prone procedures “should be identified by medical/surgical/dental organiza- tions and institutions at which the procedures are per- formed.” App. 101a. On October 28, 1991, Congress passed a law requiring the States to adopt and enforce the 1991 CDC guidelines. See Pub. L. No. 102-141, 105 Stat. 876, § 633 (1991). As of June 1993, 31 states had adopted the guidelines or equivalent requirements; 19 states and the District of Columbia had sought extensions of time in which to en- act the guidelines. Record Ex. 20-665, Ref. #4, at 6. Spattering of saliva rarely occurs in dental care. Most dentists have a dental assistant using a high speed evacuator to aspirate debris from the mouth, reducing the possibility of any spattering out of the mouth. App. 96a-99a. * A worker adhering to universal precautions assumes that all blood and certain other body fluids are potentially infectious for HIV, HBV and other pathogens. App. 103a. 1. The OSHA Standard. OSHA promulgated the final rule on December 6, 1991. OSHA did not attempt to determine whether den- tal health care workers or any other discrete group of workers are exposed to a significant risk of health impair- ment. Instead, OSHA lumped together all affected work- ers for purposes of evaluating the potential risk. OSHA also made no attempt to assess whether any provision of the final rule was reasonably necessary in health care Settings given enforcement of the CDC guidelines by OSHA and Congress’ recent mandate to the States to enforce them. OSHA found that HBV presents a significant risk of material health impairment to workers exposed to blood and other potentially infectious body fluids. App. 93a. However, OSHA concluded that “there are not sufficient data on HIV to quantify the occupational risk of infec- tion.” Jd. OSHA also briefly discussed other blood- borne pathogens, such as syphilis and malaria, but did not make any risk assessment for those diseases. App. 92a. Nonetheless, OSHA concluded that the final rule would reduce the risk of those diseases. 7d. Unlike the CDC guidelines, which give health care professionals some discretion in choosing which precau- tions to observe in particular circumstances, the blood- borne pathogens rule requires across-the-board protection whenever a worker reasonably anticipates “occupational exposure to blood or other potentially infectious mate- rials.” App. 53a, § 1910.1030(a). The rule requires ob- servance of universal precautions with respect to all poten- tially infectious materials, including “saliva in dental procedures.” App. 55a, § (b); 58a, § (d)(1). Under the CDC guidelines, “[u]niversal precautions do not ap- ply to saliva.”* App. 104a. That distinction is impor- * The CDC determined that “[g]eneral infection control practices already in existence .. . should further minimize the minute risk, if any, for salivary transmission of HIV and HBY.” App. 104a (emphasis added). 7 tant because nearly half of the 480 million annual patient visits expose dental health care workers to saliva without blood. Record Ex. 58. The rule requires use of personal protective equipment, including gloves, gowns, laboratory coats, face shields or masks, and eye protection. App. 61a-62a, § (d)(3)(i). Employers must segregate and launder all contaminated personal protective equipment, at no cost to the employee. App. 62a, § (d)(3) (iv); 68a, § (d) (4) (iv).2) Employ- ers also must comply with provisions governing “regulated waste,’ which could include such items as gloves, masks, and cotton wadding. App. 56a, 67a, § (d) (4) (iii) (B). The rule requires employers to make hepatitis B vacci- nations available at no cost to all employees who have occupational exposure. App. 72a-73a, §§ (f)(1)(i), (f)(2)(i). OSHA found that the vaccine is 96% effec- tive and that an extremely small percentage of the 4% for whom the vaccine is ineffective are at risk of hos- pitalization or death from HBV.° App. 9la. OSHA rejected a mandatory vaccination program because of privacy concerns and because mandatory HBV vaccina- tion “would not protect workers from other bloodborne pathogens.” App. 94a-95a. The final rule has a major impact on the dental care profession. Every time a dental health care worker rea- sonably anticipates exposure to saliva, he or she must don protective equipment, including a protective gown, a face shield, and gloves. If the protective equipment be- 5 The CDC, on the other hand, has concluded that the risk of disease transmission through contact with soiled linen “ts negligi- ble.” App. 103a (emphasis added). ® OSHA concluded that only 0.048 to 0.059 per thousand workers who lack immunity would die per year from HBV, and only 0.096 to 0.134 per thousand would be hospitalized annually. App. 90a, Table V-6. Thus, in a population of one million vaccinated workers, two per year would die from hepatitis B and five year would be hospitalized. 8 comes soiled with saliva, the employer must comply with the rule’s laundry and waste disposal requirements. These steps must be taken regardless of whether the worker rea- sonably anticipates exposure to blood in the patient’s saliva, and regardless of whether the worker has received the HBV vaccine. The rule imposes enormous costs on the dental health care profession at a time when the fed- eral government is considering major reforms to control the rising cost of health care." 2. The Court of Appeals’ Opinion. On December 19, 1991, pursuant to 29 U.S.C. § 655(f), the ADA petitioned for review of the blood- borne pathogens rule in the Court of Appeals for the Seventh Circuit. On January 28, 1993, the Seventh Cir- cuit issued a 2-1 opinion denying the ADA’s petition for review. The panel majority acknowledged OSHA’s failure to assess the potential risk to workers on an industry-by- industry basis. App. 8a. Nonetheless, the majority con- cluded that the risk of infection does not vary “in a readily determinable fashion from industry to industry,” since “‘[t]he risk goes with practices.” App. 9a. The majority opinion discussed HIV and HBV together, as though both pathogens justified OSHA’s decision to regulate. E.g., App. 8a-9a. The majority did not mention OSHA’s conclusion that there are insufficient data to quantify the occupational risk from HIV. The majority did not address (nor had OSHA considered) the possibil- ity of promulgating different rules based upon an assess- ment of the risks associated with each pathogen. 7™The ADA estimated that the proposed rule would cost dental employers $409 million per year. Record Ex. 20-665 at 28. That is more than half of OSHA’s estimated $813 million compliance cost for all affected industries. ee 9 Although the majority opinion equated the final rule with the CDC guidelines, App. 5a, 9a-10a, the majority did not discuss the impact of enforcement of the CDC guidelines on the potential risk to health care workers. The majority also did not discuss the cost-effectiveness of the final rule compared with regulatory alternatives, such as a mandatory HBV vaccination program. The majority opinion acknowledged significant errors by OSHA with respect to the cost of the final rule and the lives and benefits lost because of the rule. App. 6a. The majority acknowledged that the final rule “may be unnecessary; it may go too far; its costs may exceed its benefits.” App. 16a. The majority disregarded those errors and upheld the rule, concluding that a reviewing court merely patrols the boundary of reasonableness and the bloodborne pathogens rule “does not cross it.” /d.° The dissenting opinion noted that OSHA aggregated 24 industry sectors for purposes of determining whether HIV, HBV, and other viruses expose workers to a signifi- cant risk, and that OSHA equated exposure to blood with exposure to other body fluids that may carry pathogens. App. 20a, 22a. The dissenting opinion disagreed with the majority’s conclusion that the risk to workers is the same across all industries. The dissent stressed that a hospital emergency room is quite different from a dental Office. App. 23a-24a, 34a. The dissent also discussed at length OSHA’s redundant regulatory efforts, concluding that the combination of the CDC guidelines and HBV vaccinations virtually elimi- 8 The majority opinion suggested that the bloodborne pathogens rule has been accepted “by most health care industries.” App. 16a. The majority failed to mention the Court of Appeals’ refusal to allow the American College of Surgeons to file an amicus curiae brief in support of the ADA. The majority also failed to mention that the rule has a unique impact on dental health care workers because it treats “saliva in dental procedures” as potentially in- fectious material. 10 nates the risk to workers that OSHA found. The dissent noted that a mandatory HBV vaccination program would be far more cost-effective than the final rule: For reasons unknown and contrary to sound medical judgment and research, OSHA concluded that even though vaccinations would reduce almost all risk of health care professionals becoming infected by HBV, the additional, far more expensive, impractical and cost inefficient precautions were necessary. App. 33a (emphasis in original). REASONS FOR GRANTING THE WRIT I. THE COURT OF APPEALS’ DECISION RAISES IMPORTANT ISSUES CONCERNING OSHA’S OB- LIGATION TO FIND A SIGNIFICANT RISK OF HEALTH IMPAIRMENT BEFORE ISSUING A STANDARD, AND CONFLICTS WITH DECISIONS BY THIS COURT AND OTHER COURTS OF AP- PEALS. A. This Court has interpreted section 3(8) of the OSH Act, 29 U.S.C. § 652(8), to require OSHA, before it issues a standard under section 6(b)(5), to make threshold determinations (1) that a harmful physical agent poses a significant risk of material health impair- ment at existing worker exposure levels, and (2) that a new OSHA standard will substantially reduce the risk. Industrial Union Dep’t, AFL-CIO v. American Petroleum Inst., 448 U.S. 607, 641-42 (1980) (hereinafter, “Ben- zene’); American Textile Mfrs. Inst. v. Donovan, 452 U.S. 490, 506-507 (1981) (hereinafter, “Cotton Dust’). The Court of Appeals’ majority opinion effectively held that OSHA may make those determinations in a vacuum, ignoring existing regulations that reduce the risk to work- ers. When it adopted the bloodborne pathogens rule, OSHA knew the CDC guidelines, as enforced by OSHA and the States, would reduce the risk to health care reece 11 workers from exposure to HBV. Nonetheless, OSHA made no effort to ascertain the level of risk that remained or to quantify any additional margin of safety provided by the rule. The majority opinion silently endorsed OSHA’s failure to consider existing efforts to reduce occupational risk from pathogens. The majority opinion is inconsistent with this Court’s holding in Benzene that OSHA must find a significant risk facing workers before issuing a new stand- ard. See 448 U.S. at 641-42. This Court should grant the ADA’s petition for certiorari to clarify that OSHA must consider existing controls before imposing costly and burdensome new requirements on industry. B. The majority opinion also conflicts with opinions by other courts of appeals which hold that OSHA may not lump together diverse industries and harmful physical agents for purposes of determining whether workers are exposed to a significant risk. In AFL-CIO v. OSHA, 965 F.2d 962 (11th Cir. 1992), the Eleventh Circuit reviewed an OSHA air contaminants standard regulating worker exposures to 428 toxic substances. Noting the lack of risk information OSHA supplied with respect to the individual substances, id. at 975-76, the Eleventh Circuit set aside the standard, concluding that OSHA had “lumped together substances and affected industries and provided such inadequate explanation that it is virtually impossible for a reviewing court to determine if sufficient evidence supports the agency’s conclusions.” Jd. at 986. Similarly, in International Union, UAW vy. OSHA, 938 F.2d 1310 (D.C. Cir. 1991), the District of Columbia Circuit reviewed an OSHA rule requiring workers in almost all industries to lock out energy sources when servicing equipment. OSHA did not assess the level of risk within discrete subdivisions of industry, choosing in- stead to make a global determination that workers were exposed to a significant risk. Noting that “[j]ust because paper mill equipment . . . poses a significant hazard does 12 not mean that sewing machines do,” and that there were “no obvious barriers to disaggregation,” the D.C. Circuit remanded the standard to OSHA. Id. at 1322. In this case, the majority opinion held that OSHA may generically assess the risk posed by a variety of viruses, each of which presents different risks in the diverse indus- tries to which the bloodborne pathogens rule applies. OSHA designed the rule to protect workers against all pathogens, including HIV, though OSHA made the req- uisite finding of significant risk with respect to HBV only. OSHA tipped its hand in its discussion of a man- datory HBV vaccination program, which OSHA dismissed because it “would not protect workers from other blood- borne pathogens.” App. 94a. The majority opinion en- ables OSHA to bootstrap a standard for any harmful physical agent, regardless of the risk presented by that agent, onto a standard for some other agent. The panel majority believed that aggregation of 24 industry sectors was appropriate because the risk pre- sented to workers was essentially the same from one in- dustry to another. App. 9a. The majority ignored the obvious differences between exposures to blood in hospi- tal emergency rooms and surgery wards and exposures to saliva in dental offices. OSHA previously has disaggregated industries in rule- making proceedings for purposes of analyzing the risk to workers. E.g., 43 Fed. Reg. 27350, 27355-61 (1978) (final cotton dust standard). Moreover, the courts of appeals consistently have required OSHA to assess the feasibility of section 6(b)(5) standards on an industry- by-industry basis. See, e.g., AFL-CIO v. OSHA, 965 F.2d at 980; United Steelworkers of America v. Marshall, 647 F.2d 1189, 1277, 1301 (D.C. Cir. 1980), cert. de- nied sub nom., Lead Indus. Ass’n v. Donovan, 453 U.S. 913 (1981). OSHA should be required to take the same approach with respect to risk assessment. 13 The split in the courts of appeals raises a fundamental issue concerning OSHA’s obligation to make a threshold finding that workers are exposed to a significant risk. Under section 6(b)(5), the significant risk determination is crucial because it triggers the regulatory process. Once OSHA finds a significant risk, it is required to adopt a feasible standard that will abate the risk. See Cotton Dust, 452 U.S. at 508-509. This Court should grant the ADA’s petition to clarify the extent of OSHA’s obliga- tion to assess the risk presented by individual substances to workers in discrete industries. II. THE COURT OF APPEALS’ DECISION RAISES AN IMPORTANT ISSUE CONCERNING OSHA’S AU- THORITY TO IGNORE MORE COST-EFFECTIVE ALTERNATIVES TO THE STANDARD ADOPTED. Having found that HBV (but not HIV) presents a significant risk to worker health, OSHA proceeded to adopt across-the-board restrictions on the practice of den- tistry. OSHA made no attempt, however, to determine whether the rule’s requirements are cost-effective when compared to regulatory alternatives, as the decision in Cotton Dust appears to require.’ The ADA argued before OSHA and the Court of Appeals that the combination of HBV vaccination and 9“TTlf the use of one respirator would achieve the same reduc- tion in health risk as the use of five, the use of five respirators was ‘technologically and economically feasible,’ and OSHA thus insisted on the use of five, then the ‘reasonably necessary or appropriate’ limitation [of §3(8)] might come into play as an additional re- striction on OSHA to chose the one-respirator standard. In this case we need not decide all the applications that § 3(8) might have, either alone or together with § 6(b) (5).” 452 U.S. at 518-14 n.32. Cf. Building & Constr. Trades Dep’t, AFL-CIO v. Brock, 838 F.2d 1258, 1269 (D.C. Cir. 1988): “As between saving lives ex- pensively and thriftily, it would seem curmudgeonly and wasteful in the extreme (i.e., not ‘reasonably necessary’) to insist on the former. We need not, however, resolve the issue.” ie 14 enforcement of the CDC guidelines obviated any need for more comprehensive regulation by OSHA; at most, OSHA should have required vaccination of health care workers with occupational exposure to HBV. A mandatory vac- cination program would virtually eliminate the risk of HBV, which is the sole justification for the final rule. OSHA refused to adopt a mandatory vaccination rule, opting instead to require a panoply of extreme precau- tions for all workers, whether or not they have been vaccinated.”® That approach might have made sense if OSHA found that HIV or other pathogens for which there are no vaccines pose a significant risk to worker health. But OSHA did not quantify the risk of HIV and did not at- tempt to quantify the risk associated with other pathogens. The final rule thus protects the minute percentage of workers for whom the vaccine is ineffective and those who refuse inoculation. This Court should grant the ADA’s petition to provide additional guidance concerning the limits of OSHA’s authority to impose on industry costly and burdensome requirements when available alternatives are far more cost-effective. Ill. THE MAJORITY OPINION CONFLICTS WITH DECISIONS BY THIS COURT AND OTHER COURTS OF APPEALS CONCERNING THE BUR- DEN OF PROOF AND STANDARD OF REVIEW. The Court of Appeals’ majority opinion took a hands off approach to the bloodborne pathogens rule. Charac- terizing themselves as “the nonspecialist, biomedically un- sophisticated Article III judiciary,’ App. 10a, the panel majority repeatedly deferred to OSHA despite reserva- 10 OSHA had authority to adopt a mandatory vaccination pro- gram. See Jacobson v. Massachusetts, 197 U.S. 11 (1905) (vaccina- tion can be required notwithstanding religious and privacy objec- tions). 15 tions about OSHA’s findings. For example, the majority opinion agreed with the ADA that: * OSHA’s estimate of the cost of compliance with the final rule “[n]o doubt . . . is an underestimate” (App. 6a); * OSHA “exaggerated the number of lives likely to be saved by the rule by ignoring lives likely to be sacrificed by it, since the increased cost of medical care, to the extent passed on to consumers, will reduce the demand for medical care, and some peo- ple will lose their lives as a result” (id.); * OSHA ignored the impact of the final rule on the quality of dental care—“the higher price of dentistry that is a likely consequence of the rule will have a greater impact on demand; and inadequate dental care is a source of pain and suffering” (App. 9a- 10a). The majority opinion further agreed that the final rule “may be unnecessary; it may go too far; its costs may exceed its benefits.” App. 16a. Nonetheless, the major- ity deferred totally to OSHA, concluding that “we cannot resolve our doubts against the agency.” App. 6a. The majority opinion’s rationale is wrong in two re- spects. First, it improperly places the burden of proof on the ADA. OSHA bears the burden of proof in rule- making proceedings under section 6(b)(5). Benzene, 448 U.S. at 653. A reviewing court cannot accept OSHA’s findings, which the court concedes are erroneous or unfounded, merely because an industry petitioner does not prove that the rule will have disastrous consequences. Second, the majority opinion’s description of the court’s role on review conflicts with decisions by other courts of appeals. With respect to central issues such as the cost of the final rule and the net impact of the rule on health and safety, OSHA must find “substantial evidence in the 16 record considered as a whole” to justify the rule.” See 29 U.S.C. § 655(f). The substantial evidence test re- quires OSHA “to identify relevant factual evidence, to explain the logic and the policies underlying any legisla- tive choice, to state candidly any assumptions on which it relies, and to present its reasons for rejecting significant contrary evidence and argument.” United Steelworkers of America v. Marshall, 647 F.2d at 1207. See also Synthetic Organic Chemical Mfrs. Ass’n v. Brennan, 503 F.2d 1155, 1160 (3d Cir. 1974), cert. denied, 420 U.S. 973 (1975). “Considering the record ‘as a whole’ fur- ther requires that reviewing courts ‘take into account not just evidence that supports the aegncy’s decision, but also countervailing evidence.” AFL-CIO v. OSHA, 965 F.2d at 970 (quoting AFL-CIO v. Marshall, 617 F.2d 636, 649 n.44 (D.C. Cir. 1979)). The majority opinion did not probe the record to find evidence supporting OSHA’s determinations. Faced with issues that OSHA either did not address, such as the im- pact of the rule on patients, or did not support with evidence in the record, such as the cost of compliance, the majority deferred to OSHA, claiming that Article IIT judges are unqualified to pass judgment on “technical’’ issues. App. 10a. The majority opinion establishes a high water mark for deference to an agency that did not do its job. Because the majority opinion improperly shifted the burden of proof to the ADA, and because the majority opinion splits with other courts of appeals concerning the meaning and application of the substantial evidence test, this Court should grant the ADA’s petition to clarify the scope of review in OSHA rulemaking proceedings. 11 “Substantial evidence” is “ ‘such relevant evidence as a reason- able mind might accept as adequate to support a conclusion.’ ” Cotton Dust, 452 U.S. at 522 (quoting Universal Camera Corp. v. NLRB, 340 U.S. 474, 477 (1951)). 17 CONCLUSION For the foregoing reasons, the petition for a writ of certiorari should be granted. Of Counsel: MARY K. LOGAN General Counsel and Assistant Executive Director, Division of Legal Affairs KATHLEEN M. Topp Associate General Counsel AMERICAN DENTAL ASSOCIATION 211 E. Chicago Avenue Chicago, IL 60611-2678 (312) 440-2886 June 28, 1993 Respectfully submitted, W. SCOTT RAILTON * JOHN F. DIENELT CHRISTOPHER L. KILLION REBECCA R. BURKHOLDER REED SMITH SHAW & MCCLAY 1200 18th Street, N.W. Washington, D.C. 20036 (202) 457-6100 Counsel for Petitioner American Dental Association * Counsel of Record APPENDIX -- Ra nara! ae, — TABLE OF CONTENTS FOR APPENDIX Opinion of the U.S. Court of Appeals for the Seventh Circuit (Jan. 28, 1998) oo OSHA’s Final Rule on Occupational Exposure to Bloodborne Pathogens, 56 Fed. Reg. 64004, 64175 CT TD eipicincsnriinsslawiisisrenieeagi ADA’s Petition for Review, U.S. Court of Appeals for the Seventh Circuit (Dec. 16,1991) Order Consolidating Petitions for Review, U.S. Court of Appeals for the Seventh Circuit (March 6, saan Ee le RAE tLe Order Granting Motion for Extension of Time to File Petition for Rehearing, U.S. Court of Appeals for the Seventh Circuit (Feb. 10, 1998) 0 Order Denying Petition for Rehearing, U.S. Court of Appeals for the Seventh Circuit (May 27, 1993) .... Excerpts from the Preamble to the Fina] Rule on Oc- cupational Exposure to Bloodborne Pathogens, 56 Fed. Reg. 64004 (Dec. ie Selec ree oe Excerpts from Transcripts of OSHA Rulemaking NNN Sntiirrrsisocrtintscnactivicceccasuodlincc CDC, Recommendations for Preventing Transmission of Human Immunodeficiency Virus and Hepatitis B Virus te Patients During Exposure-Prone Invasive Procedures, 40 MMWR 1, 5-6 (1991) CDC, Recommendations for Prevention of HIV Trans- mission in Health-Care Settings, 36 MMWR 38, om ee CDC, Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and Other Bloodborne Pathogens in Health-Care Settings, 37 MMWR 377, 379 SII simi uss ssanncnanvenicanbisdusheianaenndaancntascatancc Page la 53a 84a 85a 86a 88a 90a 96a 100a 103a la APPENDIX IN THE UNITED STATES COURT OF APPEALS FOR THE SEVENTH CIRCUIT Nos. 91-3865, 92-1482 AMERICAN DENTAL ASSOCIATION and HOME HEALTH SERVICES AND STAFFING ASSOCIATION, INCORPORATED, Petitioners, V. LYNN MARTIN, SECRETARY OF LABOR, and OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, Respondents, and (in No. 91-3865) AMERICAN FEDERATION OF STATE, COUNTY AND MUNICIPAL EMPLOYEES, AFL-CIO, and SERVICE EMPLOYEES INTERNATIONAL UNIon, AFL-CIO, Intervening-Respondents. Petitions for Review of an Order of the Occupational Safety and Health Administration ARGUED JUNE 10. 1992—_DeEcIpDED JANUARY 28, 1993 Before Posner. COFFEY, and EASTERBROOK, Circuit Judges. 2a PosNER, Circuit Judge. In 1991 the Occupational Safety and Health Administration promulgated a rule on occupational exposure to bloodborne pathogens. 56 Fed. Reg. 64004, 57 Fed. Reg. 29206, 29 C.F.R. § 1910.1030. The rule is designed to protect health care workers from viruses, particularly those causing Hepatitis B and AIDS, that can be transmitted in the blood of patients. Promul- gated after a protracted notice-and-comment rulemaking proceeding, the rule and its supporting reasons occupy 178 densely packed pages in the Federal Register. Most em- ployers in the health care industry have accepted the rule, which in essence requires compliance with procedures for health care workers recommended by the Centers for Dis- ease Control (since renamed the Centers for Disease Con- trol and Prevention), the federal agency responsible for the control of contagious diseases. Many of these employ- ers, indeed, had adopted the procedures as soon as the CDC recommended them. Three employer groups, how- ever, challenge the rule—dentists, represented by the American Dental Association, and medical-personnel and home-health employers, both represented by the Home Health Services and Staffing Association. Medical-person- nel firms supply health care workers on a temporary basis to hospitals and nursing homes, while home-health firms supply such workers to patients at home. AIDS is caused by a virus (HIV) that can be trans- mitted, among other means, by introducing the blood of an infected person into the bloodstream of an uninfected one. If blood of a dental or medical patient who is HIV positive spatters on a health care worker’s skin where the skin is cut or abraded, or the worker accidentally sticks himself with a scalpel or hypodermic needle or other medical instrument on which there is fresh blood of an HIV carrier, the worker may become infected—with, so far as anyone knows, invariably fatal results. The AIDS virus is not, however, robust, and is not easily transmitted by the sorts of contact that patients usually have with _ 3a health care workers. As of 1991, there had been only 24 confirmed cases of U.S. health care workers infected with the AIDS virus by patients since AIDS was first diag- nosed in 198]. Hepatitis B is a far more common disease than AIDs. though less scary, publicized, or stigmatized. The Hepa- titus B virus (HBV) produces antibodies that fight the virus but at the same time destroy liver cells in which the virus has lodged. Although most infected persons recover uneventfully, about 1 percent die and about 6 to 10 per- cent of adult (and a much higher percentage of child ) victims of Hepatitis B become carriers. The virus is much more virulent than the AIDS virus, and the introduction of a carrier’s blood into another person’s bloodstream is a particularly efficient means of transmission. Unlike the AIDS virus, which cannot survive exposure to air, HBV can survive on the surface of a piece of clothing or other material at room temperature for a week and can thus be spread by dirty laundry. Also unlike the AIDS virus, there is a vaccine against HBV, effective in 85 to 97 per- cent of healthy adults who receive it. Nonetheless, be- cause of the greater virulence of HBV and the fact that many health care workers are not vaccinated, patient-com- municated Hepatitis B kills about 200 health workers in the U.S. per year—roughly 100 times the number of such workers infected by patient-communicated HIV. The precautions against infection of health care work- ers by the two viruses is similar, except that the vaccine against HBV offers a Protection that has no counterpart with regard to HIV, and contaminated laundry poses a danger of spreading HBV that also has no counterpart with regard to HIV. OSHA’s rule reflects the public- health philosophy of “universal precautions,” which means precautions against the blood of every patient, not just the blood of patients known or believed likely to be car- riers of HBV or HIV. The precautions are various. They include engineering controls (such as requirements for 4a the location of sinks), work practice controls (such as standards of care in handling contaminated sharp instru- ments, such as needles), requirements for personal pro- tective equipment such as gloves, masks, goggles, and gowns, requirements for housekeeping (covering such things as the cleaning of contaminated surfaces and laundry and the disposal of contaminated waste), report- ing requirements, and provisions for medical care. The rule requires the employer to offer employees who are at risk of exposure to the blood of patients the Hepatitis B vaccine at the employer’s own expense, though it allows the employees to decline to be vaccinated. An employee who is involved in an “exposure incident,” such as being stuck by a contaminated needle, must be offered at the employer’s expense a confidential blood test for HBV and HIV; that is, only the employee is entitled to the result of the test. In deciding to impose this extensive array of restric- tions on the practice of medicine, nursing, and dentistry, OSHA did not (indeed is not authorized to) compare the benefits with the costs and impose the restrictions on find- ing that the former exceeded the latter. Instead it asked whether the restrictions would materially reduce a signifi- cant workplace risk to human health without imperiling the existence of, or threatening massive dislocation to, the health care industry. For this is the applicable legal standard. Occupational Safety & Health Act, § 6(b)(5), 29 U.S.C. § 655(b)(5); Industrial Union Dept., AFL- CIO v. American Petroleum Institute, 448 U.S. 607, 642- 45, 655-56 (1980) (the “benzene” case) (plurality opin- ion); American Textile Mfrs. Institute, Inc. v. Donovan, 452 U.S. 490, 509-12, 530-36 (1981) (the “cotton dust” case). The agency focused on HBV rather than on HIV ecause of the minute number of health care workers who have been infected by the latter virus. It estimated that the rule would eliminate between 113 and 129 annual deaths of health care workers from Hepatitis B, and a Sa somewhat higher figure (187 to 197) if deaths of non- workers infected by health-care workers who (but for the rule) would be carriers are factored in as well. (In making this additional calculation, OSHA expressed an uncharac- teristic, but as it seems to us commendable, concern with the indirect effects of its rule. On the other hand it did not consider the reduction in medical care that might result from the rule’s effect in making the practice of medicine more costly—more on this shortly). Most of these deaths would be avoided by the vaccine, but by no means all, because the vaccine is not a hundred percent effective and, more important, because many health care workers refuse to be vaccinated. Hence the other parts of the rule would have a positive effect even on Hepatitis B; and there is no vaccine (or cure) for AIDS. OSHA’s evaluation of the effects of the rule, relying as it does on the undoubted expertise of the Centers for Dis- ease Control, cannot seriously be faulted, at least by judges. Hence we cannot say that the rule, viewed as a whole, flunks the test of material reduction of a significant risk to workplace health. As for the impact on the health care industry, OSHA estimated the total cost of compli- ance with the rule at $813 million a year, clearly not enough to break the multi-hundred-billion-dollar health- care industry. The rule’s implicit valuation of a life is high—about $4 million—but not so astronomical, cer- tainly by regulatory standards, Cass R. Sunstein, After the Rights Revolution: Reconceiving the Regulatory State 239 (1990) (App. B), as to call the rationality of the rule seriously into question, especially when we consider that neither Hepatitis B nor AIDS is a disease of old people. These diseases are no respecters of youth; they cut off people in their working years, and thus in their prime, and it is natural to set a high value on the lost years. Nor is death the only consequence of these diseases. AIDS causes protracted pain and disability before death, and Hepatitis B causes pain and disability and often per- manent liver damage, even when the patient “recovers.” 6a No doubt the agency’s 813 million estimate is an underestimate. It ignores time costs—more precisely, many or most time costs, for the statement accompanying the rule does contain a cost estimate for “work practices.” But apparently it is limited to “handwashing/glove change” and to the added time for using “safety syringes.” Those are not the only time costs, and the rest seem to have been left out. Individually slight, the time costs of suiting up with protective clothing, and of other preparatory activities required by the rule, could be cummulatively sig- nificant. Certain efficiency losses were also excluded, of which we give an example later. But the petitioners made no cffort in the rulemaking proceeding to quantify these costs or to provide any basis for supposing them to be nuge. OSHA also exaggerated the number of lives likely to be saved bv the rule by ignoring lives likely to be sacri- ficed by it, since the increased cost of medical care, to the extent passed on to consumers, will reduce the de- mand for medical care, and some people may lose their lives as aresult. The agency’s consideration of the indirect costs of the rule is thus incomplete. Cf. Competitive En- terprise Institute v. NHTSA, 956 F.2d 321 (D.C. Cir. 1992); International Union, UAW v. OSHA, 938 F.2d 1310, 1320 (D.C. Cir. 1991). How many lives the rule is likely to sacrifice, however, we do not know; and again the petitioners make no effort to come up with a number. So while $4 million doubtless underestimates the agency’s implicit valuation of each life actually likely to be saved by the rule, we do not know how great the underestimate is and we cannot resolve our doubts against the agency. We add that the $4 million ignores the benefits to workers who will be spared illness—for remember that 99 times as many people get Hepatitis B as die from it. As an original matter we might have been inclined to think that the regulation of the safety of the medical and dental workplace could be left largely to the market, that reel 7a doctors, dentists, and other health care workers have a stronger incentive than the government to protect them- selves from health hazards at reasonable cost, that their employees are compensated in their wages for what is after all a modest risk, and that health care workers who refuse to be vaccinated against Hepatitis B are knowingly assuming the risk and should be left to bear the conse- quences without government interference. But the occu- pational safety and health law is constructed on different premises that we are not free to question, and perhaps the infectious character of HTV and HBV warrant even on narrowly economic grounds more regulation than would be necessary in the case of a noncommunicable disease. The petitioners, moreover, do not attempt to blast the entire rule out of the water. They do not argue that its net contribution to the safety of health workers is likely to be trivial, or its net costs crushing. They do not contend that there should be no regulation of bloodborne patho- gens. They zero in on the particular features of the rule that pinch their clienteles and argue that the pinch is so tight that we should invalidate the rule insofar as it ap- plies to the industries that they represent. We start with the dentists. Mainly they object that they have been lumped in with medical personnel, such as surgeons, who are far more exnosed to patients’ blood than dental work- ers are and, in other respects as well, work under rele- vantly different conditions. For example, although the rule is entitled a rule about bloodborne pathogens, it re- quires universal precautions in any dental procedure in which the patient’s saliva may drip or spray or splatter on the dental worker. But it is not quite true that OSHA treated all branches of the health care industry in a lump. It gave separate consideration to every point raised before it by the dental association. It pointed out that the saliva of dental patients frequently contains blood—even in such routine procedures as having one’s teeth cleaned by a dental hygienist—and that it is possible, though far 8a from certain, that even a small quantity of blood, diluted by saliva or some other fluid, can sometimes be infective. This was not some fantasy of OSHA. The Centers for Disease Control, while generally exempting saliva from the list of body fluids to which universal precautions should apply, recommended “special precautions” for dental workers exposed to saliva from patients. Did the CDC mean universal precautions? Its language is un- clear, requiring interpretation. OSHA was entitled to adopt an interpretation that leaned “on the side of over- protection rather than underprotection.” Jndustrial Union Dept., AFL-CIO vy. American Petroleum Institute, supra, 448 US. at 656. What OSHA did not do was attempt to disaggregate the risk industry by industry. While it carefully disaggre- gated the costs of compliance, to see whether any industry within the health care sector would be imperiled by the rule, it did not attempt to determine separately the risk of HIV or HBV infection in dentistry, in home-health services, in thoracic surgery, in ophthalmology, and so forth. It did not attempt to determine the number of dental employees, say, who have contracted Hepatitis B from their patients; and it inflated the fact that only 1 of the 24 health care workers infected by a patient with AIDS in the U.S. was a dental employee by calling it a “signicant percentage” of all occupational HIV infections. Well, 4.16 percent is a significant percentage, but not a meaningful one in this case, given the smallness of the sample. Citing cases like International Union, UAW vy. OSHA, 938 F.2d at 1322, the dental association argues that the finding that the benzene opinion requires OSHA to make—“that the workplaces in question are not safe.” 448 U.S. at 642—entails a determination of the safety (or riskiness) of, at the least, each type of workplace. OSHA cannot impose onerous requirements on an indus- try that does not pose substantial hazards to the safety or health of its workers merely because the industry is a part of some larger sector or grouping and the agency 9a has decided to regulate at wholesale. That would be an irrational way to proceed. But neither is the agency re- quired to proceed workplace by workplace, which in the case of bloodborne pathogens would require it to promul- gate hundreds of thousands of separate rules. It is not our business to pick the happy medium between these ex- tremes. It is OSHA’s business. If it provides a rational explanation for its choice, we are bound. Associated Builders & Contractors, Inc. v. Brock, 862 F.2d 63, 68 (3d Cir, 1988). It explained that while the cost of com- pliance with the precautions that the CDC has recom- mended (and OSHA has required) against bloodborne pathogens varies in a readily determinable fashion from industry to industry, the risk of infection does not. The risk goes with practices (so protective clothing is required only where being splashed with blood or other infective liquid can reasonably be anticipated, whether it is a den- tist’s office or a hospital operating room) rather than with industries, and the rule is therefore based on practices rather than on industries. The HIV or HBV carrier bears menace with him as he makes the rounds from health care provider to health care provider. The risk of blood splatters and needlesticks is greater in some medical pro- cedures than in others, but a dental hygienist is as likely to be splattered by blood contained in saliva as is many a worker in a hospital or a doctor’s office. The idea be- hind requiring universal precautions for health care work- ers is to protect those workers in any situation in which there is a nontrivial risk of physical contact with a pa- tient’s blood, and these situations arise in dentists’ offices as well as in doctors’ offices and hospitals. OSHA was required neither to quantify the risk to workers’ health nor to establish the existence of significant risk to a scien- tific certainty. Industrial Union Dept., AFL-CIO v. Amer- ican Petroleum Institute, supra, 448 U.S. at 655-56. It is true that because fewer people have dental than medical insurance, and therefore more people pay for dental care out of their own pockets, the higher price of dentistry that 10a is a likely consequence of the rule will have a greater im- pact on demand; and inadequate dental care is a source of pain and suffering. But again the dental association made no effort to quantify this impact, though techniques for doing so exist in economics. As to the specific precautions required by the rule, the association makes a number of arguments, of which a rep- resentative example is that children may be traumatized by the sight of a dentist wearing goggles. “Traumatized” is putting it too strongly, and the rule does not require goggles—at least for most dental procedures, ordinary glasses with side shields are all that is required. None- theless the problem of calming children in the dentists’s chair, without resort to nitrous oxide, is a serious one that the rule may aggravate, but again the dental association makes no effort to estimate the gravity of the harm. And while as we have suggested there is a time cost to decking oneself out in protective clothing which OSHA ignored, so does the dental association. In this example, and others unnecessary to discuss, the assocation is contesting re- quirements that, whether wise or not, are within the broad bounds of the reasonable, involving as they do technical issues on which the judgments of the CDC and OSHA are entitled to respect by the nonspecialist, biomedically unsophisticated Article III judiciary, at least in the ab- sence of a more systematic showing of harms than at- tempted by the dental association. This is true even with regard to the question whether a health worker should be permitted to conceal his aware- ness of being infected from his employer and the employ- er’s patients. The problem with nonconfidential medical tests is that the cost of flunking is high—loss of a job, for example—and this deters people from taking the test. A dental worker who knew that if he were infected he would lose his job might simply not report ar exposure incident. The dental association does not argue that test- ing should not be encouraged, or alternatively that all lla dental workers should be tested regularly without regard to any exposure incidents. It asks us to balance the pros and cons of the confidentiality provision. That is not our job. We add that nothing in the rule forbids a dentist to require his employees to have a periodic HIV or HBV test, with disclosure of the results to him. The rule’s provision on confidentiality is limited to the test that an employer is required to offer a worker after an exposure incident. The dental association complains that the rule goes too far in requiring dentists to “ensure” that their employees comply with the requirements of the rule. They say this imposes strict liability, which OSHA acknowledges it can- not do. Brennan v. OSHRC, 502 F.2d 946, 951 (3d Cir. 1974); Brennan v. Butler Lime & Cement Co., 520 F.2d 1011, 1017 (7th Cir. 1975); Pennsylvania Power & Light Co. v. OSHRC, 737 F.2d 350, 354 (3d Cir. 1984). In SO saying they may seem not really to be challenging the rule but rather to be raising an interpretive question— how strictly will OSHA interpret “ensure”? Interpretive questions that cannot be answered until a rule is applied are premature when raised in a challenge to the rule on its face, mounted at the time the rule is promulgated. But here the question is neither unanswerable, nor severable from questions that clearly are ripe, such as whether the costs of compliance with the rule will be so staggering as to imperil the dental industry (in which even the rule would be invalid). The stricter the liability, the more costly the rule. It is reasonably plain, however, that OSHA did not by using the word “ensure” seek to impose strict liability. It explained that the employer’s responsibility doesn’t end with furnishing his employees with protective gear, for example: he must do everything he can reason- ably be expected to do to see that they use it. Like an employer made liable for his employees’ conduct not by the principle of respondeat superior (strict liability) but by the negligence principle. Lancaster v. Norfolk & West- ern Ry., 773 F.2d 807, 818-19 (7th Cir. 1985), which re- 12a quires due care in hiring, training, supervising, monitoring, disciplining, and retaining employees—the kind of em- ployer liability imposed in sexual harassment cases. Guess v. Bethlehem Steel Corp., 913 F.2d 463, 465 (7th Cir. 1990), in other civil rights cases, Hunter v. Allis-Chalmers Corp., 797 F.2d 1417, 1421-22 (7th Cir. 1986), and in cases under the common law’s “fellow servant” doctrine, Pomer vy. Schoolman, 875 F.2d 1262, 1266 (7th Cir. 1989)—the employer subject to OSHA’s rule on blood- borne pathogens must take all reasonable measures to prevent his employees from violating the rule, but if de- spite these measures the employee violates the rule, the employer is off the hook. Pennsylvania Power & Light Co. v. OSHRC, supra; Capital Electric Line Builders of Kansas, Inc. v. Marshall, 678 F.2d 128 (10th Cir. 1982); Brock v. L.E. Myers Co., 818 F.2d 1270, 1277 (6th Cir. 1987). The costs of compliance with OSHA’s rule, once the issue of strict liability for unforeseeable misconduct by employees is laid to one side, can hardly be thought so great as to imperil dentistry. Annualized, these costs are estimated to be equal to less than one-third of one per- cent of the industry’s annual revenues. This may over- State the actual cost, not to society as a whole (Interna- tional! Union, UAW v. OSHA, supra, 938 F.2d at 1320) but to the industry. When an industry is subjected to a higher cost, it does not simply swallow it; it raises its price and reduces its output, and in this way shifts a part of the cost to its consumers and a part to its suppliers (granted, those suppliers may include the firms constitut- ing the industry). This very point is the basis of the dental association’s argument that OSHA’s rule is likely to cause a deterioration in dental care as dental patients flee the higher prices resulting from the industry’s efforts to shift some of the costs of compliance with the rule to its cus- tomers. There are some omitted costs, as we have noted, but not enough to make a decisive difference; nor does the association emphasize them. 13a The dental association makes some other jabs at the rule, but they have less merit than those we have discussed SO we move on to the objections of the home health and medical personnel industries. These objections have greater force because they are based primarily on the fact, which has no counterpart in dentistry or for that matter in most other branches of the health industry, that the home health and medical personnel industries—we’ll call them the health personnel industry for short—do not con- trol the sites at which their employees work. This does not affect compliance with the parts of the rule relating to HBV vaccination, post-exposure testing and treatment, and recordkeeping, but it does affect the ability of the employer to comply with the requirements for protective clothing and equipment, because his employees do not work in his presence, It especially affects the employer’s ability to comply with site-specific precautions required by the rule, such as ensuring that the work site is maintained in a clean and sanitary condition and that the worker has convenient access to running water in the event of ex- posure to blood or other potentially infective materials. These problems do not seem serious with regard to the branch of the industry that supplies medical personnel to hospitals, nursing homes, and other facilities that are themselves required to comply with the rule, but they could be serious with regard to the branch of the industry that supplies personnel to homes. Save for allowing the em- ployer to substitute handwashing chemicals for a ready source of running water, the rule gives no recognition to the special problems of the industry although they were brought to OSHA’s attention during the rulemaking pro- ceeding. OSHA’s brief relies on what it calls the “multi- employer worksite defense,” whereby an employer that cannot control a hazard is not liable for the exposure of its employees to the hazard if it took whatever precau- tionary steps were reasonable in the circumstances (or reasonably lacked the knowledge to recognize a condition l4a as hazardous, but that is not a factor here). In effect OSHA asks us to read the defense into the rule. Is the absence from the rule of any explicit recognition of the acute compliance problem apparently faced by the health personnel industry, and in particular the branch that supplies medical workers to patients’ homes, a fatal omission? Administrative rules and decisions, like statutes, are enacted against a background of existing laws and understandings that do not have to be repeated in every new rule in order to have force. Perhaps the multi- employer worksite defense is so well established in the law of occupational safety and health that it formed part of the implicit background of the bloodborne-pathogens rule, which would explain OSHA’s seeming insouciance in as- similating the home personnel industry to health care in- dustries that control the sites at which the care is provided. Apart from its having been clearly stated by the Occu- pational Safety and Health Review Commission, which reviews orders of OSHA citing employers for violations of the Occupational Safety and Health Act, and endorsed by every court to consider it, see, e.g., Anning-Johnson Co., 4 O.S.H.C. 1193, 1198-99 (1976); Harvey Workover, Inc., 7 O.S.H.C. 1687, 1689 (1976); D. Harris Masonry Contracting, Inc. v. Dole, 876 F.2d 343 (3d Cir. 1989); see also Anning-Johnson Co. v. OSHRC, 516 F.2d 1081, 1089 (7th Cir. 1975), the rule or some variant of it is implicit in the principle we have just examined that the Act does not impose strict lability. One problem, however, is that the Review Commission is not OSHA. OSHA is legislator and prosecutor, OSHRC the judge. Martin v. OSHRC, 111 S. Ct. 1171, 1174 (1991); see also Cuyahoga Valley Ry. v. United Trans- portation Union, 474 U.S. 3, 7 (1985) (per curiam). By failing to mention the multi-employer worksite de- fense in the bloodborne-pathogens rule, OSHA may, de- spite its appellate lawyers’ disclaimer—which the doctrine of SEC v. Chenery Corp., 318 U.S. 80 (1943), obliges , 15a us to ignore—be signifying its disagreement that the defense is part of the law. If so, this could mean that OSHA was planning to enforce the rule as written, that is without any such defense. If that is the proper inter- pretation of the rule’s silence, we would have to invali- date the rule (in part), as we think the defense is part of the law. The alternative interpretation of the rule’s silence is that OSHA accepts the defense as something that is to be read into all of its rules: that OSHA has bowed to the Review Commission and the courts. We need not choose between these interpretations. Si- lence as acquiescence would not be an adequate response by OSHA to the circumstances of this case. The multi- employer worksite defense was developed for the con- struction industry and has, so far as we are able to dis- cover, rarely been applied outside of it. What contours it should have in so unusual a worksite setting as the health personnel industry presents should not be left to appellate tribunals, whether OSHRC or this court, to de- cide. OSHA should set the contours in the first instance. Maybe they should be narrower in this industry than in the construction industry, maybe broader, maybe differ- ent. So important a question should be settled now, not left to enforcement proceedings. Since we know that the Occupational Safety and Health Act does not impose Strict liability on employers, we know that the members of the health personnel industry need make only reason- able efforts to comply with the rule; but what this means at sites that the employers do not control eludes us. Can the employer take the position that he has no responsi- bility for the condition of those sites? Or must he inspect each site before he allows his employees to work there? Must he do that even if the site is a private home? Who knows? OSHA had an obligation to consider such ques- tions and the general issue that they present before im- posing a medley of restrictions that, so far as appears, the industry cannot comply with. l6a So the rule must be vacated insofar as it applies to sites not controlled either by the employer or by a hos- pital, nursing home, or other entity that is itself subject to the bloodborne-pathogens rule. The other objections lodged by the health personnel industry against the rule, however, either duplicate those of the dental association or plainly lack merit. So in the main the rule must be upheld. Which is not to say that it is a good rule. It may be unnecessary; it may go too far; its costs may exceed its benefits. Concern with the cost of health care in the United States is growing, and OSHA has received a steady drumbeat of criticisms even from supporters of public regulation of occupational health and safety. E.g., Sunstein, supra (index references to Occupational Safety and Health Act and Occupational Safety and Health Ad- ministration). But our duty as a reviewing court of generalist judges is merely to patrol the boundary of rea- sonableness, and, with the exception we have noted, OSHA’s bloodborne-pathogens rule—accepted as it has been by most health care industries and based as it is on the recommendations of the nation’s, perhaps the world’s, leading repository of knowledge about the control of infectious diseases—does not cross it. The petition to review filed by the American Dental Association is denied. The petition of the Home Health Services and Staffing Association is granted in part and denied in part, as explained above. CoFFEY, Circuit Judge, concurring in part, dissenting in part. Section 3(8) of the Occupational Safety and Health Act defines “occupational safety and health stand- ard” as a standard which requires the adoption of prac- tices “reasonably necessary or appropriate to provide safe or healthful employment and places of employment.” 29 U.S.C. § 652(8) (emphasis added). Section 6(b) (5) of the Occupational Safety and Health Act states: “The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under : 17a 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 func- tional 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. § 655(b) (5) (emphasis added). The dental profession, and the employees in the home health care and temporary medical services fields, argue convincingly that it is improper for the Occupational Safety and Health Administration’s final bloodborne path- ogens standard to be applied uniformly to their respective fields since the levels of exposure to bloodborne pathogens are vastly different among the various disciplines. The rule adopted can best be classified as an attempt to try to kill a fly with a sledgehammer. The rule was drafted partially in response to the public hysteria surrounding AIDS created by the media’s failure to balance their re- porting with scientific data on transmission. The rule was not drafted in response to an established significant risk of harm to employees. The dangers of transmitting the bloodborne pathogen hepatitis B have been well-estab- lished for years yet for reasons unexplained OSHA did not concern itself with that risk in the workplace prior to November 1987. Based on the record, I am forced to assume that because of the excessive media coverage re- garding the AIDS virus, fueled by one single episode involving Kimberly Bergalis in Florida contracting AIDS from her dentist, OSHA decided to promulgate this over- expansive rule (combining the AIDS virus with hepatitis 1 Medical experts have to date been unable to scientifically de- termine how the dentists, David Acer, infected his five patients. It has been reported that he may have intentionally infected them. Unfortunately, if it was in fact a criminal act, no amount of pre- caution could have prevented it. See, e.g., AIDS Infection Charge, Wash. Post, June 11, 1992 at Alz2. 18a B) in the health care field.* The rule unduly burdens health care employers, including but not limited to dentists, doctors and hospitals, while offering but minimal benefit to their employees, and furthermore it is estimated that it will increase health care costs some $817 million annually. Additionally, the rule duplicates the scientifically based and well-reasoned guidelines of the Centers for Disease Control and Prevention (CDC) a governmental agency medically and scientifically qualified to determine and evaluate if there is in fact a significant risk in the health care area and, if so, propose reasonable, efficient guide- lines. The petitioners (American Dental Association and Home Health Services and Staffing Association) base their challenges on four theories: 1) OSHA failed to establish a significant risk within their individual respective disci- plines, and thus, no basis exists for OSHA to regulate; 2) OSHA has failed to establish that the final rule will result in substantial benefit to health care workers, much less that the guidelines and regulations of the CDC and the respective states are inadequate; 3) the rule is aimed at protecting employees only and thus lacks concern for and fails to protect the consumer (dental patients and home health care patients) by increasing health care costs and at the same time denying the consumer access to essential information necesssary to the granting of in- formed consent; and 4) there are flaws in the feasibility analysis. I concur with the majority holding concerning the failure of the rule to make an exception for employers who have no control over the work site (home health 2 The rule making process actually began with a petition in 1986 from the American Federation of State, County and Municipal Employees requesting OSHA to reduce the risk to employees from infectious agents. 56 Fed. Reg. 64006 (1991). Soon thereafter, other unions (Service Employees International Union, National Union of Hospital and Healthcare Employees, RWDSU Local 1199 —Drug, Hospital and Healthcare Union) also requested a rule. Id. 19a and temporary medical services) slip op. at 15. I suggest that the United States Congress must address the question of whether there is a need to duplicate the education, investigation and prevention efforts of the CDC and state health agencies, thus increasing health care costs, and whether OSHA is the proper agency to regulate health care given their lack of experience, knowledge and ex- pertise in comparison to the CDC and state health agen- cies. In the alternative, the entire rule should be re- manded to OSHA for the reasons detailed in this opinion. I. SIGNIFICANT RISK In Industrial Union Dep’t v. American Petroleum Inst., 448 U.S. 607, 642-44, 100 S. Ct. 2844, 2864-65 (1980) (the Benzene case), the Supreme Court required that OSHA determine whether a “significant risk” exists before it can promulgate a rule. The Court’s mandating this analysis demonstrated concern that an insignificant risk must not be allowed to “justify pervasive regulation lim- ited only by the constraint of feasibility” and to restrain OSHA’s “power to impose enormous costs that might produce little, if any, discernible benefit.” Benzene, 448 U.S. at 645, 100 S. Ct. at 2865. For regulations under § 6(b)(5), such as the bloodborne pathogens standard, “the logic of Benzene thus calls for a fairly high standard of significance.” International Union, UAW v. OSHA, 938 F.2d 1310, 1322 (D.C. Cir. 1991). The Benzene case places the burden of proof on OSHA to demonstrate that a significant risk of harm to employees exists. Ben- zene, 448 U.S. at 653, 100 S. Ct. at 2869. Additionally, § 6(b)(5) of the Occupational Safety and Health Act mandates that OSHA standards satisfy the “best available evidence” and feasibility requirements. 29 U.S.C. § 655(b) (5). OSHA states that in an attempt to satisfy the best available evidence requirement concern- ing the risk of bloodborne pathogens it conducted a num- ber of hearings and received a myriad of comments prior 20a to the adoption of the final rule.* Further, OSHA sets forth that it reviewed nationwide statistical sample sur- veys from health care disciplines * to determine the possi- bility of exposure to blood or other potentially infectious materials in twenty-four (24) industry sectors.° 56 Fed. Reg. 64041-64043. Even though the U.S. Supreme Court held in American Textile Mfrs. Institute, Inc. v. Donovan, 452 U.S. 490, 101 S. Ct. 2478 (1981) (the Cotton Dust case), that OSHA is not required to conduct a cost benefit analysis when promulgating a rule under § 6(b)(5), the Supreme Court explained the propriety of OSHA adopting the most cost-effective regulation: 3 OSHA states that during its regional hearings, it analyzed the testimony and information of some 400 witnesses plus 3000 written comments, 56 Fed. Reg. 64008. For reasons unexplained, OSHA decided to address the entire health care industry (combining dis- ‘ciplines with hundreds of thousands of individuals in diverse and unrelated fields as well as joining together both rural and metro- politan areas, see infra note 5) rather than addressing the risk of exposure to bloodborne pathogens in their unique and respec- tive disciplines. As a result, the cumbersome 174 page rationale for the rule in the Federal Register can be digested and analyzed with only the greatest of difficulty. 4 The sectors of health care workers OSHA investigated include physicians and surgeons, registered nurses, therapists, lab tech- nicians, emergency medical technicians, surgical technicians, other health professionals, licensed practical nurses, therapy assistants, physician assistants, medical assistance, nursing aides, dentists, dental hygenists, and dental assistants. 5 The 24 industry sectors include: offices of physicians (includ- ing ambulatory medical services), dental offices, hospitals, medical and dental laboratories, nursing homes, residential care facilities, dialysis centers, drug treatment centers, home health care, hospices, government outpatient facilities, blood collections and processing, health clinics and industrial facilities, personnel services, funeral homes and crematories, research laboratories, linen services, medi- cal and dental equipment repair, law enforcement, fire and rescue, correctional institutions, schools, lifesaving, and regulated waste removal. 56 Fed. Reg. 64041. 2la “In addition, if [1] the use of one respirator would achieve the same reduction in health risk as the use of five, [2] the use of five respirators was ‘techno- logically and economically feasible,’ and [3] OSHA thus insisted on the use of five, then the ‘reasonably necessary or appropriate’ limitation might come into play as an additional restriction on OSHA to choose the one-respirator standard. In this case we need not decide all the applications that § 3(8) might have, either alone or together with § 6(b)(5).” 452 U.S. at 514 n.32, 101 S. Ct. at 2493 n.32. Thus it is reasonable to expect OSHA not only establish that a sig- nificant risk exists but also that the regulation adopted is the most cost-effective procedure. While I agree with the majority that “we are not free to question” Congress’ intentions in granting OSHA the power to regulate the workplace, maj. op. at 6, I do not believe that Congress ever intended that OSHA regulate the highly technical health care field. Congress was in no position in the year 1970 to foresee the dramatic advance- ments in the field of medical technology, such as heart catheterization and angioplasty procedures, heart bypass surgery, Organ transplants, microscopic surgery, and the developments in nuclear medicine among others. Nor do I think Congress intended for OSHA to invade the privi- leged relationship between medical professionals and their patients. Accordingly, Congress may wish to revisit this matter to determine whether OSHA is the most qualified agency to regulate health care as we move into the 2lst century. Il. DISAGGREGATING INDUSTRIES WHEN PERFORMING SIGNIFICANT RISK ANALYSIS The majority acknowledges that “OSHA cannot impose onerous requirements on an industry that does not pose substantial hazards to the safety or health of its workers 22a merely because the industry is a part of some larger sec- tor or grouping and the agency has decided to regulate at wholesale.” Maj. op. at 8. In order to achieve its de- sired result of regulation, OSHA made a hodgepodge of findings (estimating the number of health care workers infected with hepatitis B, and combining the risk of ex- posure to all bloodborne phathogens in the various fields of medical and dental endeavor) resulting in nothing but a generalized determination of significant risk applicable to the twenty-four industry sectors noted above. It would have been more scientifically acceptable had OSHA disag- gregated the twenty-four sectors (even those with as few as 8,000 employees, see infra note 8) to determine if in fact a scientifically established risk existed in a specific field of health services as opposed to a hypothesized risk.* Although I realize OSHA need not “establish the existence ® OSHA also considered those non-healthcare workers who might incur occupational exposure to blood (including janitorial, laundry and school workers) to have risk similar to health care profes- sionals. “Therefore OSHA will use the data available for health care workers with occupational exposure to predict the HBV in- fection risk to any worker with occupational exposure to blood or other potentially infectious material.” 56 Fed. Reg. 64026. OSHA combined the non-healthcare worker with the trained professional health care worker but disregarded the fact that the non-healthcare worker may not have had any training in infection prevention as contrasted with medical and dental professionals who have had training during their respective scholastic endeavors plus followup seminars. Interestingly, in an area where I agree OSHA might well have the required expertise, the rule does not govern barbers and cosmetologists, where cleanliness should be mandated but is not always the rule. Barbers and cosmetologists when using sharp instruments (including razors and scissors) are exposed to their clients’ blood as well as exposing clients to their own blood, more frequently than many other disciplines governed by this rule. The frequency of a barber or tonsorial employee inadvertently draw- ing blood from a customer warrants greater consideration of the likelihood of spreading infectious viruses like HBV and HIV than does a professional in a one-chair dental office in a rural commu- nity, an orthodonist, or one who practices in a specialty where laceration or puncturing of the gum tissue is the exception. 23a of significant risk to a scientific certainty,” maj. op. at 9, OSHA must do more than rely on estimates of risk. OSHA’s application of the law in that manner is directly contrary to the D.C. Circuit’s recent decision in /nterna- tional Union, UAW v. OSHA, which states: “OSHA nowhere explains its logic. Just because paper mill equipment (which was already subject to a lockout requirement) poses a significant hazard does not mean that sewing machines do. While we have recognized OSHA’s need to avoid “minuscule industry subcategories” for administrative conveni- ence, .. . there are no obvious barriers to disaggrega- tion here. In fact, OSHA has in past years promul- gated a wide variety of industry and equipment- specific lockout standards. As we have insisted that OSHA explain its refusal to disaggregate at the be- hest of unions claiming that reliance on broad cate- gories denied them adequate protection, . . . we similarly remand for it to explain how its aggregated approach here conforms to its interpretation of the act.” 938 F.2d at 1322 (emphasis added) (citations omitted). Certainly OSHA can neither logically nor reasonably claim that the dental, home health and temporary medical personnel sectors are “minuscule industr[y] subcategories” when one considers that there are some 316,000 affected dental employees, 212,246 affected home health employ- ees and 163,477 affected temporary medical personnel 56 Fed. Reg. 64055. An example of OSHA’s hodgepodge of findings is the method it used in determining whether a significant risk of infection exists. OSHA combined the risk of infection during surgical procedures in large metro- politan area public hospitals with the risk in a single chair dental practice and in a home health care environment (private residence care). As established in this opinion, OSHA has failed in the record to accurately or scientific- 24a ally analyze the risk of exposure to bloodborne pathogens. This is most evident from OSHA’s decision to combine the risks of the individual sectors in the health care area and then conclude that its self-generated, artificial risk level exists in each respective health care area. It is in- teresting to note that this commingling of diverse groups is contrary to OSHA’s prior practice of disaggregating in- dustries in rule making proceedings for purposes of ana- lyzing significant risk when promulgating a rule governing exposure to toxic substances. See 29 C.F.R. at 1910.1043 (a)(2) (OSHA’s final Cotton Dust standard); Texas In- dependent Ginners Ass’n v. Marshall, 630 F.2d 398, 403 (Sth Cir. 1980)." OSHA properly excluded the cotton ginning industry from the airborne concentration of cotton dust standard because “gin employees are only exposed to cotton dust for a short season, . . . the proper maximum level is not known for such seasonal exposure and. . . the emission controls are infeasible ....” Jd. at 403.° The court added that imposing emission controls on the cotton 7There are other examples of OSHA excluding specific sectors from a rule. See 29 C.F.R. §§ 1910.1001(a) (1)-(2), 1910.1025(a) (2) (asbestos, tremolite, anthroyphyllite, actinolite, and lead ex- posure rules); 29 C.F.R. §1910.1018(a) (inorganic arsenic ex- posure rule); 29 C.F.R. § 1910.261(a) (1) (pulp, paper, and paper- board mill regulation). 8 The ginners numbered at most 58,968 employees (calculation based on 21 employees for each of 2808 cotton gins in the U.S., this number is probably quite high since many ginners work at more than one gin during the season). 43 Fed. Reg. 27427 (1978). The total number of employees affected by cotton dust was somewhere between 420,000 and 800,000. American Textile Mfrs. Institute Inc. v. Donovan, 452 U.S. 490, 500, 101 S. Ct. 2478, 2485 (1981); AFL- CIO v. Marshall, 617 F.2d 636, 646 (D.C. Cir. 1979). Another example of OSHA drafting rules for a particular seg- ment of industry is the promulgation of rules to cover only those 8,136 employees in the underground construction industry, 54 Fed. Reg. 23824, 23846 (1989), 67,728 employees affected by ethylene oxide, 53 Fed. Reg. 11,414, 11.421 (1988), 69,000 (OSHA estimate) loggers, 54 Fed. Reg. 18,798, 18,810 (1989), and 145-180.000 ship- yard employees, 53 Fed. Reg. 48,150, 48,162 (1988). 25a ginning industry would “increase the canstautiar aot af the average gin by sixty-five percent and would increase the farmer’s cost by fifty percent.” /d. Certainly, if OSHA is able to create an industry-specific feasibility analysis for the cotton ginning industry of 58,000 em- ployees and other industries (see supra footnote 8), it can and should in fairness to the dental profession, con- sisting of over 316,000 employees, be required to create an individual industry specific significant risk analysis. 56 Fed. Reg. 64055.” Apparently OSHA realized it was unable to establish a significant risk in the appellants’ re- spective fields and or for the sake of convenience chose to combine the risk present in the entire health care area. Furthermore, based on the record it is evident that OSHA failed to consider the unique, separate and distinct risks of occupational exposure to the HBV and HIV viruses when it determined that there is a “significant risk” in the health care profession. For instance, of the twenty-five cases studied of health care workers infected with HIV through occupational exposure not one home health care employee and only one dentist (of the 100,000 practicing dentists in the United States) tested positive.’® 56 Fed. Reg. 64017-19 (listing the cases worldwide where occupational exposure to HIV infected blood was the sus- pected cause of a healh care worker’s positive HIV test). Certainly one suspected case of occupational transmission of HIV falls far short of establishing a significant risk to the dental field of over 100,000 practicing dentists and thus fails to warrant much less justify OSHA’s all-protec- tive and all-encompassing rule. 9 313,219 of those employees are dentists, dental hygienists or dental assistants who have received training in infectious disease control. The remainder are housekeepers or provide janitorial serv- ices in dental offices. See 56 Fed. Reg. 64043. 10 The dentist denied having other risk factors for AIDS (such as intravenous drug use) but OSHA stated “other modes of trans- mission cannot be ruled out.” 56 Fed. Reg. 64017, 64019. ———— 26a OSHA, in its questionable quantitative risk assessment, perhaps in an attempt to enlarge its sphere of influence or as a result of responding to well-organized political pressure, failed to analyze and weigh the varying risk levels among respective disciplines (dentists, home health, surgeons, etc.) when determining significant risks for HBV infection due to the lack of epidemiological data relating to the individual disciplines. 56 Fed. Reg. at 64023-64032. To fill this void, OSHA chose to rely on those CDC statistics that it deemed helpful in determining the annual and lifetime risk levels for HBV infection in the health care field as a whole. /d. at 64026 (“Of the 280,000 HBV infections each year (based on 1988 Hepa- titis Surveillance data), CDC estimates that 8,700 cases ccur in health care workers with occupational exposure .’). OSHA’s use of the HBV statistics is highly suspect in that they merely relied on an estimate of the number of infected health care employees rather than determining the number through a scientific survey. With- out the use of these speculative statistics, OSHA would in all probability have been unable to establish compelling results to satisfy the significant risk requirement in either the dental or the home health disciplines. OSHA’s decision to ignore varying risk levels in the respective health care disciplines appears to be nothing but a scheme to achieve a desired result for the sake of “administrative convenience.” See International Union, 938 F.2d at 1322. The failure to analyze, quantify, and document the data on the particular risk factors the den- tal, home health, and temporary medical services individ- ually might incur vis-a-vis the other identified health care sectors results in a quagmire of highly suspect estimates of the risk of HBV infection in the appellants’ disciplines. OSHA, as have others before, demonstrated the truth of the well-known saying that people can use statistics to make any point they want. Above all, this type of “reli- ance on overbroad categories denie[s] [industries] ade- quate protection” from overreaching regulation. See id. 27a OSHA conceded the effect of International Union when it stated, “[that case] stands only for the proposition that OSHA must consider any record evidence that shows a wide variation in incident rates among industries in decid- ing whether to regulate on an aggregated basis.” OSHA Brief at 17. Because of the established “wide variation in incident rates” of exposure to bloodborne pathogens, OSHA, if it was in fact attempting to achieve accuracy, should have disaggregated the individual disciplines in determining the existence of a significant risk. The professional training the vast majority of health care workers undergo in infectious disease prevention, in addition to complying with the CDC Guidelines, and the respective state and professional regulations are more than an adequate safeguard to combat the minimal risk of infection existing in a dental office or home health care place of employment. On October 28, 1991, Congress en- acted a law requiring that states adopt and enforce the 1991 CDC guidelines. See Pub. L. No. 102-141, 105 Stat. 876, § 633 (1991). Because of the Supreme Court’s ruling in Gade vy. National Solid Wastes Management Ass'n, 112 S. Ct. 2374 (1992), the OSHA regulations preempt any comparable state regulations, i.e., the 1991 CDC guidelines. Interestingly, the CDC guidelines are patient oriented as contrasted with the OSHA rule which is employee oriented. The OSHA rule leaves much question in light of the fact that the dentists and their support staff are well- trained during their respective dental educational pro- grams as well as their continuing professional dental semi- nars in how to prevent and control exposure to infection but at the same time the consumer-patient is not as for- tunate and ih thus uninformed as to both the risk and the techniques or methods of prevention. Rather than having the CDC and OSHA rules conflict with one another, re- sulting in confusion as well as government waste from duplication of effort, one governmental organization should be drafting and be responsible for enforcing a 28a logical, scientifically acceptable, cost-conscious rule which would in turn protect not only the medical and dental per- sonnel but the consumer-patient as well. [ understand that OSHA did consider some of the Dental Association’s concerns, see, e.g., 56 Fed. Reg. at 64103 (addressing the ADA’s argument that saliva should not be included in the standard), but in large part this pro forma treatment of challenges to the standard was inadequate. OSHA did not specifically find that dentists and home health workers were exposed to risk anywhere near a level that could be labeled significant. Ill. SIGNIFICANT BENEFITS Benzene states “that Congress intended, at a bare mini- mum, that [OSHA] find a significant risk of harm and therefore a probability of significant benefits before estab- lishing a new standard” and requires that the Occupa- tional Safety and Health Administration find 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.” Benzene, 448 U.S. at 642, 645, 100 S. Ct. at 2864-65." The starting point for this significant risk 1! Section 2 of Executive Order No. 12,291 provides: In promulgating new regulations . . . all agencies, to the extent permitted by law, shall adhered to the following re- quirements... (b) Regulatory action shall not be undertaken unless the potential benefits to society from the regulation outweigh the potential costs to society ; (c) Regulatory objectives shall be chosen to maximize the net benefits to society .... 46 Fed. Reg. 13,193 (1981). In Corrosion Proof Fittings v. E.PA.., 947 F.2d 1201 (5th Cir. 1991), the court emphasized the need for the Environmental Protection Agency to exercise reasonable judg- ment when regulating toxic substances and to weigh the burden of a proposed regulation with the benefit. Jd. at 1220-23. I realize OSHA and EPA operate under different enabling statutes, but the holding of Corrosion Proof Fittings offers guidance as to how all federal agencies should regulate. a TT 29a analysis should be the current state of regulation and the risks present thereunder based on recognized and accepted empirical data. OSHA admittedly did not consider the present state of regulation including the CDC Guidelines adopted by the states,’” other individual state and profes- sional regulations, and the increased use of HBV vaccina- tions in the dental profession (71% of the nation’s roughly 100,000 dentists are vaccinated, while 41% of the nearly 5 million health care workers in the entire health care profession are vaccinated, 56 Fed. Reg. 64027, 64092). OSHA Brief at 20. OSHA acknowledges that the HBV vaccination is 96 percent effective, id. at 64027, and “(t]he risk of HBV infection is most efficiently and dra- matically reduced by vaccinating all workers exposed to blood and other potentially infectious materials.” Jd. at 64036. Therefore, mandating HBV vaccination for all health care personnel insures far greater reduction of risk at a minimum of expense than do the requirements of wearing shoe covers or thirty-year record keeping, etc. I certainly do not oppose the reasonable recognized safe- guards including but not limited to the use of goggles, gloves, masks, sterilization and waste disposal in a hospital 12On July 12, 1991, the Center for Disease Control (CDC) issued recommendations for preventing transmission of HIV and HBV during “exposure prone invasive procedures.” The CDC guidelines require all health care workers to “adhere to universal precau- tions, including the appropriate use of hand washing, protective barriers, and care in the use and disposal of needles and other sharp instruments.” The guidelines also require that health care workers comply with current guidelines for disinfection and ster- ilization of reusable devices used in invasive procedures.” Impor- tantly, the CDC guidelines allow medical organizations to identify which invasive procedures are “exposure-prone.” See, e.g., Ill. Admin. Code tit. 77 § 693.10-693.45 (1992); Ind. Admin. Code tit. 410 § 1-4 (1992); the Wisconsin Department of Health and Social Services has adopted voluntary guidelines to be enforced by the Department of Regulation and Licensing, see Recommendations for Preventing Transmission of HIV and HBV (October 28, 1992). 30a setting.* However, I fail to understand the need for separate and distinct governmental agencies to regulate the same subject matter particularly when the CDC is so eminently qualified through its knowledge, expertise, pro- fessional personnel, and continued research combined with its experience. The Supreme Court has held that a “rule is arbitrary and capricious if the agency . . . entirely failed to consider an important aspect of the problem.” Motor Vehicle Mfrs. Ass'n v. State Farm Mutual Ins. Co., 463 U.S. 29, 43 (1983). In my opinion, the failure of OSHA to take cognizance of the effectiveness and imple- mentation of current state and federal (CDC) regulation and guidelines (including HBV vaccination statistics) leads to but one conclusion, that the final rule can and must be classified as arbitrary and capricious. Above all, regulation of this type is just one more ex- ample of governmental waste. The much maligned health care field and its insurance systems are struggling and almost bankrupt partially because of excessive unneces- sary regulations of this nature that are not only duplica- tive but are also less than cost efficient. OSHA further exacerbates the health care crisis when it enters into the fields of medicine, and dentistry, and related support staff, where it falls short of being either qualified or experienced to exercise regulatory oversight. My concerns about the 13 The observance of well-recognized infection prevention proce- dures greatly reduces the risk of infection to health care employees. One CDC study concluded: “There is no evidence that medical or dental workers identified by [HBV] testing who practiced good techniques will transmit hepatitis B to their patients.” Hepatitis B Transmission Between Dental or Medical Workers and Patients, 95 Annals of Internal Medicine 229, 230 (1981). “[O]ne is left with the conclusion that a major amount of HBV transmission re- sults from failure to observe good standards of dental and medical practice.” Jd. The CDC identified following “‘universal precautions including glove use’”’ as procedures to reduce the spread of infec- tion. There is no need for a separate federal agency (OSHA) to mandate new and unnecessary rules when appropriate standards already exist. aceite anand 3la inefficiency of having another federal agency regulate den- tists and home health employees applies with equal force to the other health care disciplines covered by the rule though they are not party to this suit. OSHA’s regula- tion of doctors’ offices (at a cost of $144 million an- naually) and hospitals ($322 million) will merely dupli- cate the educational, investigative and research efforts of the CDC, state health agencies, hospital associations and professional organizations. This regulation upon regula- tion only serves to exacerbate the skyrocketing costs of health care in America. I disagree with my two colleagues, who are both prop- erly recognized and respected as experts in the field of economics as well as law, but who have overlooked the lack of marginal benefit in the final ruie. The majority maintains that OSHA “is not authorized to . . . compare the benefits with the costs and impose the restrictions [the Bloodborne Pathogens Standard] on finding that the former exceeded the latter.” Maj. Op. at 4 (citing 29 U.S.C. § 655(b) (5); Benzene, 448 U.S. at 642-45, 655- 56; Cotton Dust, 452 U.S. at 509, 530-36). Accordingly, OSHA only examined “whether the restrictions would materially reduce a significant workplace risk to human health without imperiling the existence of, or threatening massive dislocation to, the health care industry.” Maj. Op. at 4. As I have previously mentioned (see supra at 20), the Supreme Court has recommended that OSHA pursuant to § 3(8) of the Act, consider drafting the less costly of two equally effective proposals: “the ‘reasonably necessary or appropriate’ limitation might come into play as an additional restriction on OSHA to choose the [least costly regulation].” Cotton Dust, 452 U.S. at 514 n.32. Moreover, I am aware of no rule barring OSHA’s apply- ing reasonable judgment and fiscal responsibility. OSHA should have taken into consideration that a qualified gov- ernmental agency with a wealth of medical and scientific expertise was already responsible for the health care pro- fession and thus OSHA could not hope to accomplish any- ee 32a thing that the CDC was unable to achieve more effec- tively. (Perhaps this could be achieved by congressional action giving the CDC the same inspection and enforce- ment powers as OSHA). Furthermore, had OSHA con- sidered and analyzed the marginal costs and benefits of its regulations as applied to the dental, home health care and personnel services professions, they would have foregone promulgation of the rule, because less costly, less intrusive regulations are available and have effectively reduced the risk of exposure to bloodborne pathogens. In OSHA’s explanation of why the regulation is war- ranted, it admits: “The risk of HBV infection is most efficiently and dramatically reduced by vaccinating all workers exposed to blood and other potentially infectious materials.” 56 Fed. Reg. 64036. Yet, in spite of the find- ing that vaccination is the most efficient preventative measure, rather than making vaccination mandatory, the government, through OSHA, proceeded to create the pres- ent bureaucratic rule which will magnify the costs of health care by over $800 million annually to consumers based upon the weak excuse that “not everyone is willing to accept the vaccine.” /d. at 64037. The majority main- tains that “the vaccine is not a hundred percent effective and, more important, .. . many health care workers re- fuse to be vaccinated.” Maj. op. at 5. While there are a certain number of people who refuse to be vaccinated, this certainly is not a valid reason to reject mandatory vac- cination of health care workers. Thus, this argument can best be classified as a red herring. To realize that vac- cinations are a reality in this day and age, one need only look to the infant children who must and do receive vac- cinations before entering school and when not vaccinated are refused admission to attend classes. Other examples of compliance with mandatory vaccination programs in- clude those traveling abroad who are denied visas or en- try into certain foreign countries and the over two million men and women in the armed services. The vast majority of dental schools are requiring proof of vaccination before a 33a accepting incoming students as is evidenced by the in- crease in the percentage of incoming dental students who have received HBV vaccination from fifty-one percent in 1986 to eighty-six percent in 1988, and among dental hy- giene students from sixty percent in 1986 to eight-five percent in 1988. Appendix to OSHA Brief at 44 (citing V. Merchant & J. Molinari, The Current Status of Infec- tion Control in North American Dental Schools 9 (Mar. 14, 1989)). For reasons unknown and contrary to sound medical judgment and research, OSHA concluded that even though vaccinations would reduce almost all risk of health care professionals becoming infected by HBV, the additional, far more expansive, impractical and cost inefficient precautions were necessary. Id. at 64036-38. In part, OSHA justified the need for the entire bloodborne pathogens standard because it “will also reduce[e] the risk of infection to HIV.” Jd. at 64038. This rationale is neither scientifically nor medically established and is thus arbitrary and capricious and falls far short of being sup- ported with substantial evidence because OSHA itself con- cedes “there are no sufficient data on HIV to quantify the occupational risk of infection.” Id. (emphasis added). OSHA should not be allowed to impose on the health care industry, during these times crying for fiscal responsibility, a rule whose benefits and safeguards could be achieved through a far more cost effective and efficient means (mandatory vaccination) both to the consumer and the government alike. See Cotton Dust, 452 U.S. at 514, n.32 (suggesting that the “reasonably necessary or appropri- ate” language of § 3(8) might require OSHA to select the less expensive of two equally effective measures ). OSHA’s fatal error, in my opinion, occurred when it failed to recognize and consider the varying risk of occu- pational exposure in the respective appellants’ professions. “Infected [health care workers] who adhere to universal precautions and who do not perform invasive procedures pose no risk of transmitting HIV and HBV to patients.” Centers for Disease Control, 40 MMWR 1, (July 12, 34a 1991) (emphasis added). Dentists, for example, are not exposed to the same level of risk as other health care work- ers such as surgeons, nurses or other medical personnel in large metropolitan hospital’s emergency or operating rooms, just as cotton gin workers are not exposed to the same risk as are other cotton industry employees. A large number of dentists both in general practice and in a num- ber of specialties, unlike surgeons in hospital settings, have little exposure to blood. See ADA Brief at 10.* Despite the testimony of over 400 witnesses and an additional 3000 written comments, before this court, OSHA relies on but one single 1988 article (Infection control recommen- dations for the dental office and the dental laboratory, 116 J.A.D.A. 241 (Feb. 1988) ) to support its claim that den- tal workers are at risk of acquiring HBV. OSHA Brief at 18. The article fails to take into account the most recent safeguard innovations such as the increased use of the HBV vaccine by the dental and medical professionals, and the implementation of recent CDC Guidelines.*° OSHA ar- gues that having to condust a significant risk analysis for each industry would hamper its ability to regulate.’® This 14] recognize the possibility of occupational exposure to blood- borne pathogens in a dentists’ office. However, a dentist’s risk is far less than that of that of other health care professionals, such as orthopedic, heart, vascular or neurosurgeons, and thus they are less susceptible to occupational exposure to bloodborne pathogens. The dentist normally operates in a controlled environment (90% of patients have an appointment as contrasted with a hospital emergency room) and thus knows what to expect and/or how to prepare the staff for possible exposure to infection from any given patient as well as knowing when and where to wear gloves or a mask if necessary in the exercise of acceptable medical judgment. OSHA appendix at 48 (citing 1988 ADA survey). 15 The risk of exposure is also reduced because many dentists now use aspirators placed directly in the oral cavity that contin- ually withdraws the blood seeping from the puncture or laceration of gum tissue thus eliminating to a great extent the chance of ex- posure to the dentist or employees. OSHA appendix at 50. 16 OSHA relies on Associated Builders and Contractors, Inc. v. Brock, 862 F.2d 63, 68 (D.C. Cir. 1988), cert. denied, 494 U.S. 1003 35a is another example of OSHA’s less than scientific ap- proach to drafting this rule, for I firmly believe that in the interest of fairness to the professions it is incumbent that OSHA undertake a thorough risk analysis and not merely rely on estimates. Moreover, OSHA’s argument that its rule making will be hampered is undermined by the fact that much of the statistical material (including the research necessary to produce a significant risk analysis) was either in the hands of or readily available to OSHA. OSHA attempts an end run around the significant risk/ benefit issue by arguing that the dental industry does not have a “zero risk” (and I might add who does—the un- regulated barber, the cosmetologist?). This argument is without merit because it completely disregards and casts aside the burdens established in Benzene. Benzene re- quires OSHA to make a finding that the employees to be regulated are exposed to a significant risk. 448 US. at 642, 100 S. Ct. at 2864. Benzene does not require that the appellants establish a “zero risk” in their professions. There may well be a danger of transmitting infection in the dental and home health environments but it is neither scientifically nor medically established in the record before us. Therefore, if Congress fails to intervene, the reasoned and proper judgment of the court should as a last resort be to remand the final bloodborne pathogens standard to OSHA with directions to determine whether a significant risk exists when considering the various appellants’ pro- (1990), which held “[a] requirement that the Secretary assess risk to workers and need for disclosure with respect to each substance in each industry would effectively cripple OSHA’s performance of the duty imposed on it... .” OSHA’s reliance on Associated Builders is misplaced because that case involved “thousands of chemical substances used in numerous industries,” id., the blood- borne pathogens standard only involves one substance (blood) and only a handful of distinct sectors. Clearly disaggregation would have been possible and appropriate. For a brief discussion of the problems posed by OSHA inspec- tors seeking to enforce the rule see infra at 48. 36a fessions individually. OSHA must also determine and ex- plain whether the final rule results in significant benefits through the use of recognized empirical data. IV. PROTECTION FOR THE EMPLOYEE BUT NOT THE PATIENT The appellants also argue that the OSHA regulations fail to consider the very important interests of the con- sumer-patient in knowing whether his health care provider is infected with a bloodborne disease thus permitting the patient to make an informed and reasonable judgment as to whether they wish to discontinue treatment with the infected practitioner or a member of his staff. The appel- lants stress that the CDC Guidelines, while not requir- ing health care workers to be tested for viruses, do re- quire (relying on the honor system) that infected workers report to a health care committee for recommendation as to whether they may perform invasive procedures. The CDC Guidelines also properly recommend that infected health care workers inform patients of their infected status before performing invasive procedures: “HCWs who are infected with HIV or HBV .. should not perform exposure-prone procedures unless they have sought counsel from an expert review panel and have been advised under what circum- stances, if any, they may continue to perform these procedures. Such circumstances would include noti- fying prospective patients of the HCW’s sero positiv- ity before they undergo exposure-prone invasive pro- cedures.” Centers for Disease Control, 40 MMWR 5 (July 12, 1991) (emphasis added) footnote omitted). 17 Additionally, the American Medical Association and the Amer- ican Dental Association have recommended that HIV-infected per- sonnel should refrain from performing invasive procedures. Karen C. Lieberman & Arthur R. Derse, HIV-Positive Health Care Work- ers and the Obligation to Disclose: Do Patients Have a Right to 37a I am well aware that many individuals in the medical community oppose disclosure of a health care profession- al’s HIV status. I disagree with their point of view for I believe the consumer-patient’s interest is paramount for he or she is entitled to be made aware of this informa- tion in order that they might make an informed health care decision before undergoing any medical or dental procedure (if indeed there is a risk of HIV or HBV in- fection as OSHA contends). A primary reason many medical professionals oppose disclosure is that they are interested in protecting their fellow professionals whose practices might decline or cease to exist if patients knew their physician or treating health care worker was afflicted with an infectious disease. This practice is contrary to the response the medical community and public health offi- cials take toward infected food workers (requiring medi- cal treatment and prohibiting employment, see infra at 40). The opposition to disclosure does not stem from a concern for the consumer-patient who merely seeks to make an informed health care decision. I understand OSHA’s congressionally delegated respon- sibility is to protect employees, in doing this however, OSHA completely cast aside the interest of the consumer- patient and focused exclusively on the confidentiality in- terests of the health care employees. OSHA rationalizes this by stating that confidentiality of records will encour- age employees to report exposure incidents (I disagree that it will encourage reporting but it might conceivably make employees somewhat less inhibited to report expo- sures). 56 Fed. Reg. 64160. After an “exposure inci- dent” '* to patient blood or other potentially infectious Know?, 18 J. Legal Medicine 333, 339 (1992). It seems quite ob- vious that the CDC, state agencies and professional organizations (who are more qualified than OSHA) should establish the regula- tions and guidelines that govern the health care profession. 18 “Peposure incident means a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or 38a material like saliva,’ the rule requires employers to pro- vide confidential blood testing from a health care profes- sional for their employees. Importantly, in § 1910.1030 (f)(5)(ii) of the bloodborne pathogens standard “the healthcare professional’s written opinion for post-exposure evaluation and follow-up shall be limited to the following information: “(A) that the employee has been informed of the results of the evaluation; and “(B) that the employee has been told about any medical conditions resulting from exposure to blood or other potentially infectious materials which re- quire further evaluation or treatment. “(iii) All other findings or diagnosis shall remain confidential and shall not be included in the written report.” Bloodborne Pathogens Standard § (f)(5)(ii)-(iii) (em- phasis added). In the record-keeping section, the final rule states: “(h)(1)(1) The employer shall establish and main- tain an accurate record for each employee with occu- pational exposure, in accordance with 29 C.F.R. 1910.20.... “(iii) Confidentiality. The employer shall ensure that employee medical records required by paragraph (h)(1) are: other potentially infectious materials that results from the per- formance of an employee’s duties.” 56 Fed. Reg. 64175 (quoting § 1910.1030(b) of the Bloodborne Pathogens standard). 19 There are reputable commentators who maintain that saliva, rather than transmitting HIV, may actually inhibit its transmis- sion. P. Fox, et al., Salivary Inhibition of HIV-1 Infectivity: Func- tional Properties and Distribution in Men, Women and Children, 118 J. Am. Dental Assoc. (JADA) 709 (1989). 39a “(A) Kept confidential; and “(B) Are not disclosed or reported without the em- ployee’s express written consent to any person within or outside the workplace except as required by this section or as may be required by law.” Id. § (h) (1) (i)-(ii). The meaning of the language “as may be required by law” is indefinite, yet OSHA argues that § (h) (1) (iii) (B) permits disclosure of employee records as required by state law (inferring patients somehow may be able to acquire information necessary to granting informed con- sent). Interestingly though, even if the record is open to inspection as OSHA alleges, the record fails to contain any information dealing with the employee’s infection status (positive or negative), because § (f)(5)(b) (iii) of the bloodborne pathogens standard prohibits the employ- ee’s health record from revealing such information. This rule denying the consumer-patient valuable information flies directly in the face of the professional norms in the health care industry (which is bound by the common law of informed consent)” and defies objectivity, fairness 20 Lieberman & Derse, supra note 17, document the cases giving rise to the common law right to informed consent and conclude that a patient has a right to know whether his health care provider is HIV-infected. Jd. at 342-456. “As a further consideration, even if it is assumed that the risk of transmission from health care worker to patient drug during an invasive procedure is quite low, various courts have held that the fact a risk is remote will not always negate the duty to disclose under the informed consent doc- trine.” Jd. (citations omitted). “The fact that the health care pro- fessions themselves are uncertain about the degree of risk to patients is all the more reason why patients should be in a posi- tion to decide for themselves whether to accept the risk, as the courts have held.” Jd. at 348 n.91. “While the risk of transmis- sion of HIV from health care worker to patient during an invasive procedure may be low, the consequence of the occurrence of that risk at this time appears invariably to be death.” Jd. at 350. “When a health care worker permits a patient to be placed at risk in order to obtain personal benefit, even when the risk is as potentially re- a 40a and common sense.”" The courts have long recognized the right of a patient to determine what medical procedures he or she will undergo, see, e.g., Cruzan v. Director, Missouri Dep't of Health, 497 U.S. 261, 110 S. Ct. 2841, 2851 (1990); Schloendorff v. Society of New York Hosp., 105 N.E. 92, 93 (N.Y. 1914); and therefore a health care professional may not deny information relevant to making an informed decision as to a medical or dental procedure. Lieberman & Derse, supra note 17 at 342 (citing Salgo v. Leland Stanford Jr. Univ. Bd. of Trustees, 317 P.2d 170, 181 (Cal. App. 1957) (“A physician violates his duty to his patient . . . if he withholds any facts which are necessary to form the basis of an intelligent consent... . Likewise, the physician may not minimize the known dangers of a procedure or operation in order to induce his patient’s consent.) ). The confidentially provision also conflicts with a den- tist’s ability to prudently and effectively manage his office. State statutes permit a health care provider to inform his staff assisting him in providing care to a patient if that patient is HIV positive to ensure extra precaution. See, e.g., Ill. Ann. Stat. ch. 111% para. 7309(c) (Smith-Hurd 1988); Wis. Stat. Ann. § 146.025(5) (West 1989). So too should a dentist, physician, surgeon, hospital adminis- trator or other health care professional be entitled to know whether an employee in his office is infected, thus presenting a risk to himself as well as his patients, or mote as transmitting HIV to an uninfected patient, the health care worker’s interests conflict with those of the patient [in vio- lation of the fiduciary duty].” Jd. at 353. 21 Eighty-six percent of adults surveyed in a Gallup Poll said patients “should be told if the health care worker caring for them has AIDS.” Larry Gostin, Hospitals, Health Care Professionals, and AIDS: The “Right to Know” the Health Status of Profes- sionals and Patients, 48 Md. L. Rev. 12, 14. Without such infor- mation, a patient who is infected by a health care professional could unwittingly spread the infection to others. 4la fellow employees by exposing them to the risk of infection during a procedure. Certainly it cannot be labeled dis- crimination when enacting rules and/or regulations that prevent one with a communicable virus from spreading that infectious virus to an uninformed, trusting consumer. See Americans with Disabilities Act 42 U.S.C.A. § 12113 (b) (West. Supp. 1992) (“The term ‘qualification stand- ards’ may include a requirement that an individual shall not pose a direct threat to the health or safety of other individuals in the workplace.”).** Public health officials, [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386019_1085%3A1. Public record. Not legal advice.