Petition for Writ of Certiorari — American Dental Ass'n v. Reich

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» Bpreme Court, U.S

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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)

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 ...............

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

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.

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).

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-

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.

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).

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.

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.

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.

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

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

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.

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.”

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).

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

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)).

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

53a

84a

85a

86a

88a

90a

96a

100a

103a

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,

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.

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

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

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

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.”

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

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

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

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 ;

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-

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

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-

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,

when informed, have the responsibility to see that a food

worker infected with either the hepatitis A virus or the

tuberculosis virus is barred from employment in all as-

pects of the food industry. Jd. § 12113(d). Do not

justice and logic dictate that the same measures be taken

to prevent a health care employee with a bloodborne virus

from exposing a patient to infection? Does not the con-

sumer have at least equal rights to protection against

infection as the health care provider has? It is evident

that the quagmire of regulations from OSHA, the CDC,

state agencies and professional organizations yield a con-

fusing morass of conflicting intentions, goals, rules and

regulations.

The root of much of this dispute is a vocal minority’s

emphasis on the rights of the individual at the expense

of the common good of all. The defeat of the congres-

sional attempt to require mandatory testing of health care

workers can only be expalined by powerful lobbying ef-

forts. See generally William B. Rubenstein, Law and

Empowerment: The Idea of Order in the Time of AIDS,

98 Yale L.J. 975, 993-94 (1989) (book review discussing

22 OSHA’s Bloodborne Pathogens Standard makes no provision

for an employer to be made aware of his employee’s health status

through a documented record or health report even when the em-

ployee may suffer from fatigue and thus render a less than pro-

fessional performance or expose himself or another to danger be-

cause of HBV or HIV infection.

‘a

impact of lobbyists). It is incumbent upon Congress to

address and take an in-depth look at the AIDS problem

and achieve a balance that reflects the paramount interest

of all mankind and not let the overriding concern be with

the individual’s right of privacy.

Additionally, OSHA is attempting to regulate a “toxic

substance” (human blood) which is unique from all other

areas of OSHA regulation yet it lacks the required exper-

tise, knowledge or experience in the highly specialized

field of health care to evaluate the necessary scientific,

medical, and or dental data. See, State of Wisc., Dep’t of

Health v. Bowen, 797 F.2d 391, 412 (7th Cir. 1986)

(Coffey, J., dissenting) (“‘Nameless, faceless, lay govern-

ment officials have neither the knowledge of the patient’s

needs, the medical training, nor the authority to” intrude

into medical and dental procedures.). OSHA was origi-

nally created to protect the workers in the factory and

construction environments and, as a result of knowledge

and experience is well-equipped to regulate those indus-

tries, but I have very serious doubts about their qualifi-

cations to monitor the health care field, including but not

limited to dentists, doctors and hospitals. See OSH Act

of 1970, P.L. 91-596, 1970 U.S.C.C.A.N (91 Stat.)

5177, 5178-81 (discussing industrial risks and never men-

tioning the health care profession). I suggest that the

Congress reexamine OSHA’s role in regulating the highly

technical health care sector and see if that area might

better be served by an agency or agencies possessing the

required expertise in the discipline, such as the Centers

for Disease Control in the Department of Health and

Human Services and the respective qualified state con-

trolled agencies and professional organizations. The CDC

has been investigating, compiling data, and dealing with

the health risks in the workplace for years and in turn

disseminates its findings as well as this vital health care

information throughout the nation. State health agencies

frequently use this information along with the CDC guide-

43a

lines to aid in the states’ regulation of the health care

profession. Because the states have the capability of con-

temporaneous oversight and timely inspections, they have

traditionally regulated health care, and thus have acquired

a tremendous amount of experience and expertise in the

field. Consequently, it is both unnecessary and wasteful

for OSHA to usurp the functions of the CDC and the

states in health regulation. Having OSHA defer to the

CDC and state health agencies when regulating health

care is similar to the government’s leaving nuclear regula-

tion to the Nuclear Regulatory Commission, (it would be

absurd for the inexperienced OSHA inspectors to regu-

late the nuclear workplace environment and the employees

of power plants, arms production or nuclear waste facili-

ties). I am of the opinion that allowing OSHA inspectors,

who lack the necessary knowledge and expertise, to regu-

late and intrude into the highly technical medical pro-

cedures of the 20th and 21st centuries is at best extremely

suspect.

In a typical workplace, such as a factory, government

regulation limits an employee’s exposure to toxic materials

like lead or asbestos. These regulations are designed to

benefit the worker only and not impact third parties. In

reality though, there is an indirect impact on the con-

sumers who are required to pay the higher price for the

product affected by the unnecessary piling on of needless _

and ineffective regulations on top of regulations. In the

health care field, however, the third party (the innocent

uninformed consumer-patient) is directly exposed and im-

pacted by the regulations with possible fatal consequences

(according to OSHA). For this reason, OSHA, in the ex-

ercise of logic, common sense and fairness should have

also considered the interest of the patient and sought to

protect the consumer-patient from possible harmful expo-

sure to bloodborne viruses. Because the final rule fails

to consider the health care consumer, it is flawed and

cries out for judicial and/or congressional intervention

44a

to weigh and balance the documented concerns and pro-

tect the innocent and uninformed health care consumer

as well as the emplovees.

Further evidence that the regulations fail to consider

the preeminent interests of patients is found in the ex-

cessive record keeping requirements imposed on health

care employers (thirty years beyond an employee’s tenure

with the employer).** This thirty-year record keeping re-

quirement will have little or no impact on reducing the

spread of infectious diseases in the health care industry,

rather it merely creates another administrative nightmare

and increases the already prohibitive cost of purchasing

medical and dental services. OSHA estimated the annual

cost of record keeping alone to be in excess of $17 million.

56 Fed. Reg. 64064. This figure, in all probability, fails

to include costs for increased clerical needs, storage

facilities or the time of health care professionals interfer-

ing with patient care and valuable research. Despite well-

supported objections to the thirty-year record keeping

requirement, OSHA cavalierly concluded:

“that this provision is neither excessive nor imprac-

tical when viewed from the perspective of the em-

ployee. Vaccination records are an essential part of

an employee’s medical history. OSHA believes that

retention of these records and exposure incident rec-

23 OSHA rationalizes the thirty year requirement by stating:

“Retaining medical records for the period of employment plus

thirty years is necessary because hepatocellular carcinoma,

which can occur as a result of hepatitis B infection can, and

indeed commonly does, take twenty to thirty years to develop.

Individuals who become HBV carriers or develop chronic hepa-

titis are often ill and infected for the rest of their lives. More-

over, OSHA believes this is an appropriate time period, in

light of the fact, that 5% of those exposed to HIV infected

blood do not seroconvert within six (6) months. Finally, the

time period for retention of records is consistent with other

OSHA standards requiring retention of occupational medical

records.”

56 Fed. Reg. at 64171.

45a

ords is necessary to assist current and future health

care professionals in assessing an employee’s medical

history and prescribing medical treatment.”

56 Fed. Reg. at 64171. This reasoning lacks concern for

the provider as well as the consumer-patient who bears

the cost without a recognizable benefit.

Viewing this provision as applied to temporary services

reveals its true absurdity. Because many temporary med-

ical personnel serve more than one temporary services

employer (often for less than a week and sometimes for

but a day), each employer is required to incur the added

expense of maintaining and storing duplicative records of

each employee for a period of thirty years. This require-

ment could have been eliminated or more properly trans-

ferred by placing the responsibility on the employee. Re-

quiring health care employees to carry a health card re-

vealing recorded vaccinations, known exposure incidents

and any other pertinent information would eliminate a large

portion if not the majority of the estimated $17 million in

paperwork and poses no more burden on an employee

than carrying a drivers license, a permit, social security

card, or charge card. Moreover, it is in the employee's

best interests to have this vital information in record form

in his or her possession in case of medical emergency or

future employment. As the majority maintains, the pro-

fession could regulate itself because “health care workers

have a stronger incentive than the government to pro-

tect themselves from health hazards at a reasonable cost

.”” Maj. Op. at 6. The regulation, however, reflects

an agency decision to make society bear the costs of in-

dividuals who do not want to be inconvenienced. OSHA,

for reasons unexplained in this record, ill-advisedly chose

to impose the costs for medical records of employees (who

allegedly do not want to be inconvenienced by vaccina-

tions or maintaining personal vaccination records) on the

already financially strained health care consumer.

46a

V. FEASIBILITY

Section 6(b)(5) of the OSH Act requires that final reg-

ulations be feasible. The figures that OSHA used to

conduct the feasbility analysis were flawed resulting in a

misleading and foundationless economic picture. I agree

that the cost effects of the final rule are understated as the

majority observes. Maj. Op. at 5-6 (discussing under-

stated “time costs” “‘ of compliance and the number of

lives the rule will save). Additionally, a significant over-

sight in the feasibility analysis is that the majority of dental

patients directly pay for their own dental expenses due to

the limited coverage of dental insurance and its high cost.

Therefore, dentists will in all probability be unable to pass

on the costs of complying with the rule as readily as doc-

tors or hospitals (who serve a greater percentage of pa-

tients with insurance coverage), because patients without

insurance will defer or forego dental treatment rather

than pay the higher cost. ADA Brief at 38-39; OSHA ap-

pendix at 46. Obviously, dental practitioners. like busi-

nessmen, either absorb the costs or pass them on to their

patients. In an era of decreasing demand for dental serv.

ices (dental school closings result in fewer dentists prac-

ticing, H. Barry Waldman, Dental School Demographics:

More than Just Decreases in the Overall Number of Stu-

dents, 57 J. Am. Coll. Dentists 22 (1990)), the vast

majority of dentists should not be put in the position of

having to bear additional costs of unnecessary govern-

24 One example of understated time costs concerns those prac-

ticing in Pediatric Dentistry. The ADA has argued that a child

may be traumatized by the sight of a dentist wearing goggles and

a mask. This argument only scratches the surface of the real prob-

lem. A dentist wearing goggles and a mask may have to take more

time to calm a child (especially one in for emergency treatment

because of an injury) before instituting treatment. Those children

needing to be calmed frequently must undergo a general anesthesia

rather than a topical anesthesia. This increases the risk to the

child as the number of assistants necessary to position and monitor

the child patient, the cost, and the potential liability to the den-

tist as well as increasing the time to conduct the procedure.

47a

mental regulation. The combination of fewer practicing

dentists along with the impact of the OSHA rule can

only produce an increase in fees for dental services. The

majority mentions that OSHA and the Dental Association

have “ignored” the “time costs” of the rule. Maj. op. at

9-10. I would not classify the Dental Assocation’s brief as

ignoring the time cost (Appellants Brief at 40-41) but I

agree they failed to quantify and itemize those costs.

Nonetheless, the consumer will ultimately bear the burden

of the increased costs of providing dental services.

Another example of the flawed feasibility analysis is

that OSHA failed to include disposal costs of non-reusable

personal protective equipment (PPE) or laundry costs for

reusable PPE. 56 Fed. Reg. 64065 (OSHA includes no

cost for laundering reusable gowns and only $.32 per

dental office as the annual cost of bags for disposable

gowns and PPE). In 1987, the CDC stated “[a]lthough

soiled linen has been identified as a source of large num-

bers of certain pathogenic microorganisms, the risk of

actual disease transmission is negligible. Rather than

rigid procedures and specifications. hygienic and common-

sense storage and processing of clean and soiled linen are

recommended.” CDC, 36 MMWR at 11S (August 2.

1987). Despite this CDC finding concerning laundry.

OSHA has created stringent laundering regulations. 56

Fed. Reg. 64178. The ADA has estimated the annual

cost of laundering reusable PPE at $115 million ~® which

25 Additionally, the estimated cost of reusable gowns is approxi-

mately $28 million, resulting in a total cost of $143 million to sat-

isfy the laundering regulations. OSHA did not prepare any cost

estimates on the cost of the purchasing and laundering reusable

fabric gowns. 56 Fed. Reg. 64065; ADA Appendix at 220.

This court attempted, though unsuccessfully, to resolve the con-

fusion between the ADA’s laundering estimate during the rule

making procedure and the estimate in their brief before this court.

Unfortunately, we have only an index of documents filed during

the rule making and any cost estimates derived subsequent to the

rule making procedure are inadmissible.

48a

exceeds all the costs of compliance with the regulations

that OSHA identified for the whole dental profession.”

OSHA responds that because of the high costs of launder-

ing, most dental practitioners would decide to employ dis-

posable protective equipment. For some reason, OSHA

failed to factor in the costs of storing and disposing of

such waste but should have for I know of very few dental

practitioners with an incinerator or the facilities to store

and transport infectious waste to an incinerator in their

respective office buildings. 56 Fed. Reg. 64065. Addi-

tionally, OSHA estimated the cost of a disposable gown

at $.32 while the ADA estimates the actual cost of a fluid

resistant gown is $2.50. OSHA appendix at 64.°7 These

oversights certainly call into question whether the rule is

supported by substantial evidence.” I disagree with the

26 Some confusion exists as to cost estimates because the rule

applies only to employees. For the purpose of the rule, a dentist

who has incorporated his or her practice (S.C.), probably for tax

purposes, is considered an employee of the corporation while a den-

tist who has not incorporated is not an employee and thus not

covered under OSHA. Therefore, OSHA can minimize the costs

of complying with the rule by only including the costs of those

dentists who are employees of corporations.

27 In their brief before OSHA responding to the proposed blood-

borne pathogens standard, the ADA estimated the cost of compli-

ance with the rule to be $524,541,564. OSHA appendix at 49-50.

OSHA’s estimate that the rule will increase costs of health care

by $817 million annually is certainly an understatement. More im-

portantly though, considering the fact that the states, the CDC

and the professional groups are and have been regulating for a

period of time, could not these same dollars be more wisely spent

on research to halt the deadly effects of heart disease, cancer,

stroke and AIDS?

28 Another omission in the feasibility analysis is the failure to in-

clude any costs for complying with the OSHA engineering stand-

ards in §§ (d) (2) (iii), (d) (4) (iii) (B) requiring employers to make

sinks readily accessible for hand washing (irrespective of the fact

the states already have similar regulations) and ensuring proper

storage of regulated waste. 56 Fed. Reg. 64065. A final example of

the flawed feasibility analysis is OSHA’s estimate that the proce-

49a

majority that the omitted costs, such as the thirty-year

record-keeping and laundering requirements, are “not

enough to make a decisive difference.” Maj. op. at 12.

Only a complete and accurate feasibility study will deter-

mine whether the rule is warranted.

Regarding the temporary medical personnel services,

the feasibility analysis is likewise misleading. OSHA cal-

culated an annual turnover rate among registered nurses

between 12.9 and 21.8 percent and among licensed prac-

ticing nurses and nurses aides between 22.5 and 36.3 per-

cent. The temporary services sector, however, has turn-

over rates from three to five times greater than the rest

of the profession. HHSSA appendix at 2 (testimony of

James Keefe, Sept. 21, 1989, on bloodborne pathogens

standard, Exhibit 55). Many temporary service employ-

ees work as brieflly as one week for an employer and the

majority are employed by the same employer for less

than six months. 7d. Such a disparity in turnover rates

certainly negates the accuracy of OSHA’s feasibility analy-

sis and calls into question the validity of the rule as ap-

plied to the temporary services field.

Finally, OSHA fails to enumerate how it intends to en-

foce this standard. Do they intend to invade the privi-

leged relationship between a doctor and or dentist and

his or her patient? Do they intend to hire thousands of

new inspectors to enforce this rule? We now have over

three million civilian federal employees—do we need

more? Are they going to transfer the inspection respon-

sibility to the states along with all the enforcement ex-

dure following an employee’s exposure to bloodborne pathogens,

§ (f) (3), would only take 20 minutes. For a hospital employee (with

immediate access to a physician) this may be reasonable, but for

a dental worker this procedure would more likely take one-half

day traveling to and from the office in addition to the waiting time,

time for taking the medical history including information concern-

ing the exposure incident, as well as the time for testing pro-

cedure in the physician’s office. This would amount to 12-14 lost

work days per year. OSHA appendix at 71-72.

50a

pense? Do they expect voluntary compliance which all

too frequently results in universal disregard for the law?

VI. CONCLUSION

I am cognizant of the need for dental and medical reg-

ulations and safeguards to insure and prevent the spread

of infection, but fail to understand why OSHA must as-

sert authority over the health care field when it lacks

the required medical knowledge, training, and experience,

much less expertise. In the absence of proof that the

CDC Guidelines are inadequate, any regulation by OSHA

is unnecessarily dupliactive of CDC efforts and merely

serves to increase health care costs with little if any cor-

responding benefit. Moreover, OSHA’s method of at-

tempting to satisfy the significant risk standard was less

than desirable. OSHA should have disaggregated each of

the health care disciplines, in particular, the larger ones,

including hospitals (2.3 million employees), physicians’

offices (640,000 employees), and dental offices (316.000

employees) (see supra note 5 listing the twenty-four sec-

tors covered by the rule), in order to accurately deter-

mine if a significant risk of exposure exists in the par-

ticular field and whether the rule results in significant

benefits to the particular discipline. Combining the mil-

lions of health care workers into one group and then

merely relying on estimates of risk is a less than accept-

able manner of regulating the nearly five million health

care workers in this country.

The majority dismisses out of hand several valid ADA

arguments, maj. op. at 12, such as the burden of the

thirty-year record-keeping requirement, costs of launder-

ing and difficulties of complying with the post-exposure

procedures. I have attempted to address some of these

issues in order to present a more complete analysis should

Congress decide to take an in-depth look at this prob-

lem to determine if OSHA should exercise its authority

in the same realm as the CDC and the State health agen-

cies. If Congress concludes there is a need for two fed-

Sla

eral agencies—in addition to state agencies and profes-

sional organizations—to exercise oversight in the health

care field, then Congress must acknowledge their respon-

sibility for increasing the cost of health care.

Should Congress after due deliberation and debate ex-

press its desire for more regulation of health care, then

OSHA, with the exercise of proper judgment, could draft

a very concise regulation designed to protect employers,

employees and patients and segregate the different areas

of health-care. The most effective and cost-efficient reg-

ulation would be to require HBV vaccinations for all

health care workers at risk of exposure in the United

States, and to enforce existing state regulations, the 1991

CDC Guidelines (requiring universal precautions), and

the OSHA general personal protective equipment rules.

29 C.F.R. 1910.132(a). Such a rule would eliminate

nearly any potential of a health care worker contracting

an infectious disease in the workplace as well as demon-

Strating proper fiscal responsibility on the part of the

government. As previously mentioned, OSHA itself ac-

knowledges that HBV vaccinations are 96 percent effec-

tive at preventing infection. Not only would such a rule

be far more effective than the proposed rule, the costs

of this regulation would be dramatically reduced from

that proposed by OSHA.

There is no need for four separate entities (OSHA,

CDC, state agencies, and professional organizations) to

regulate the health care industry based on one suspected

case of a dentist becoming infected with HIV through

work related exposure. One qualified entity can most

effectively and efficiently regulate the health care pro-

fession. I see no reason why the respective states are

unable to continue to regulate the medical and dental

profession as the states have traditionally done in the

past and presently do in many other professional fields

including but not limited to law, engineering and _ ar-

chitecture.

52a

“It is elemental that a state has broad power to

establish and enforce standards of conduct within its

borders relative to the health of everyone there. It

is a vital part of a state’s police power. The state’s

discretion in that field extends naturally to the regu-

lation of all professions concerned with health.”

Barsky v. Board of Regents, 347 U.S. 442, 449 (1954),

see also State of Wisc., Dep’t of Health v. Bowen, 797

F.2d 391, 413 (7th Cir. 1986) (Coffey, J. dissenting).

Furthermore, OSHA may be highly qualified to regulate

everything from construction and manufacturing to the

foundations of the high trapeze act in the circus, but I

am of the opinion that as presently constituted it is un-

qualified to regulate fields of medicine and dentistry and

their supporting staffs.

Finally, there is little doubt that lobbyists and the media

in all probability have greatly impacted OSHA’s rule mak-

ing. Sadly, while billions of dollars are and will be spent

enforcing OSHA’s bloodborne pathogen standard as pres-

ently drafted (merely duplicating the research and over-

sight of other qualified agencies), these same funds could

be more wisely expended to aid the millions of Americans

who continue to die from the nation’s three leading killers

(heart disease, cancer, and stroke) as well as AIDS and

other diseases.”

A true Copy:

Teste:

Clerk of the United States Court of

Appeals for the Seventh Circuit

29 See, e.g., Budget of the United States Government (Fiscal Year

1993). Part One at 113-115, U.S. Government Printing Office

(1992).

53a

FEDERAL REGISTER

Vol. 56, No. 235

Friday, December 6, 1991

RULES AND REGULATIONS

XI. The Standard

General Industry

Part 1910 of title 29 of the Code of Federal Regula-

tions is amended as follows:

PART 1910—[ AMENDED]

Subpart Z—[ Amended]

1. The general authority citation for subpart Z of 29

CFR part 1910 continues to read as follows and a new

citation for § 1910.1030 is added:

Authority: Secs. 6 and 8, Occupational Safety and

Health Act, 29 U.S.C. 655, 657, Secretary of Labor’s

Orders Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059),

or 9-83 (48 FR 35736), as applicable; and 29 CFR part

1911.

Section 1910.1030 also issued under 29 U.S.C. 653.

* ** * *

2. Section 1910.1030 is added to read as follows:

§ 1910.1030 Bloodborne Pathogens.

(a) Scope and Application. This section applies to all

occupational exposure to blood or other potentially in-

fectious materials as defined by paragraph (b) of this

section.

(b) Definitions. For purposes of this section, the fol-

lowing shall apply:

aac eeeenemenle

S4a

Assistant Secretary means the Assistant Secretary of La-

bor for Occupational Safety and Health, or designated

representative.

Blood means human blood, human blood components,

and products made from human blood.

Bloodborne Pathogens means pathogenic microorgan-

isms that are present in human blood and can cause

disease in humans. These pathogens include, but are not

limited to, hepatitis B virus (HBV) and human immuno-

deficiency virus (HIV).

Clinical Laboratory means a workplace where diagnos-

tic or other screening procedures are performed on blood

or other potentially infectious materials.

Contaminated means the presence or the reasonably

anticipated presence of blood or other potentially infec-

tious materials on an item or surface.

Contaminated Laundry means laundry which has been

soiled with blood or other potentially infectious materials

Or may contain sharps.

Contaminated Sharps means any contaminated object

that can penetrate the skin including, but not limited to,

needles, scalpels, broken glass, broken capillary tubes, and

exposed ends of dental wires.

Decontamination means the use of physical or chemical

means to remove, inactivate, or destroy bloodborne path-

ogens on a surface or item to the point where they are no

longer capable of transmitting infectious particles and the

surface is rendered safe for handling, use, or disposal.

Director means the Director of the National Institute

for Occupational Safety and Health, U.S. Department of

Health and Human Services, or designated representative.

Engineering Controls means controls (e.g., sharps dis-

posal containers, self-sheathing needles) that isolate or

55a

remove the bloodborne pathogens hazard from the work-

place.

Exposure Incident means a specific eye, mouth, other

mucous membrane, non-intact skin, or parenteral contact

with blood or other potentially infectious materials that

results from the performance of an employee’s duties.

Handwashing Facilities means a facility providing an

adequate supply of running potable water, soap and single

use towels or hot air drying machines.

Licensed Healthcare Professional is a person whose

legally permitted scope of practice allows him or her to

independently perform the activities required by para-

graph (f) Hepatitis B Vaccination and Post-exposure

Evaluation and Follow-up.

HBV means hepatitis B virus.

HIV means human immunodeficiency virus.

Occupational Exposure means reasonably anticipated

skin, eye, mucous membrane, or parenteral contact with

blood or other potentially infectious materials that may

result from the performance of an employee’s duties.

Other Potentially Infectious Materials means

(1) The following human body fluids: semen, vaginal

secretions, cerebrospinal fluid, synovial fluid, pleural fluid,

pericardial fluid, peritoneal fluid, amniotic fluid, saliva in

dental procedures, any body fluid that is visibly contami-

nated with blood, and all body fluids in situations where

it is difficult or impossible to differentiate between body

fluids;

(2) Any unfixed tissue or organ (other than intact

skin) from a human (living or dead); and

(3) HIV-containing cell or tissue cultures, organ cul-

tures, and HIV- or HBV-containing culture medium or

56a

other tissues from experimental animals infected with

HIV or HBV.

~—-Parenteral means piercing mucous membranes or the

skin barrier through such events as needlesticks, human

bites, cuts, and abrasions.

Personal Protective Equipment is specialized clothing

or equipment worn by an employee for protection against

a hazard. General work clothes (e.g., uniforms, pants,

shirts, or blouses) not intended to function as protection

against a hazard are not considered to be personal pro-

tective equipment.

Production Facility means a facility engaged in indus-

trial-scale, large-volume or high concentration production

of HIV or HBV.

Regulated Waste means liquid or semi-liquid blood or

other potentially infectious materials; contaminated items

that would release blood or other potentially infectious

materials in a liquid or semi-liquid state if compressed;

items-that-are caked with dried blood or other potentially

infectious materials and are capable of releasing these ma-

terials during handling; contaminated sharps; and patho-

logical and microbiological wastes containing blood or

other potentially infectious materials. =

Research Laboratory means a laboratory producing or

using research-laboratory-scale amounts of HIV or HBV.

Research laboratories may produce high concentrations of

HIV or HBV but not in the volume found in production

facilities.

Source Individual means any individual, living or dead,

whose blood or other potentially infectious materials may

be a source of occupational exposure to the employee.

Examples include, but are not limited to, hospital and

clinic patients; clients in institutions for the development-

ally disabled; trauma victims; clients of drug and alcohol

treatment facilities; residents of hospices and nursing

57a

homes; human remains; and individuals who donate or

sell blood or blood components.

Sterilize means the use of a physical or chemical pro-

cedure to destroy all microbial life including highly re-

sistant bacterial endospores.

Universal Precautions is an approach to infection con:

trol. According to the concept of Universal Precautions,

all human blood and certain human body fluids are

treated as if known to be infectious for HIV, HBV, and

other bloodborne pathogens.

Work Practice Controls means controls that reduce the

likelihood of exposure by altering the manner in which a

task is performed (e.g., prohibiting recapping of needles

by a two-handed technique).

(i) Each employer having an employee(s) with occupa-

tional exposure as defined by paragraph (b) of this sec-

tion shall establish a written Exposure Control Plan

designed to eliminate or minimize employee exposure.

(ii) The Exposure Control Plan shall contain at least

the following elements:

(A) The exposure determination required by paragraph

(c)(2).

(B) The schedule and method of implementation for

paragraphs (d) Methods of Compliance, (e) HIV and

HBV Research Laboratories and Production Facilities,

(f) Hepatitis B Vaccination and Post-Exposure Evalua-

tion and Follow-Up, (g) Communication of Hazards to

Employees, and (h) Recordkeeping of this standard, and

surrounding exposure incidents as required by paragraph

(f)(3) (i) of this standard.

58a

(iii) Each employer shall ensure that a copy of the

Exposure Control Plan is accessible to employees in ac-

cordance with 29 CFR 1910.20(e).

(iv) The Exposure Control Plan shall be reviewed and

updated at least annually and whenever necessary to re-

flect new or modified tasks and procedures which affect

occupational exposure and to reflect new or revised em-

ployee positions with occupational exposure.

(v) The Exposure Control Plan shall be made avail-

able to the Assistant Secretary and the Director upon

request for examination and copying.

(2) Exposure determination. (i) Each employer who

has an employee(s) with occupational exposure as defined

by paragraph (b) of this section shall prepare an exposure

determination. This exposure determination shall contain

the following:

(A) A list of all job classifications in which all em-

ployees in those job classifications have occupational

exposure;

(B) A list of job classifications in which some employ-

ees have occupational exposure, and

closely related task and procedures in which occupational

exposure occurs and that are performed by employees in

job classifications listed in accordance with the-provisions

of paragraph (c)(2)(i)(B) of this standard.

(ii) This exposure determination shall be made without

regard to the use of personal protective equipment.

(d) Methods of compliance—(1) General—Universal

precautions shall be observed to prevent contact with

blood or other potentially infectious materials. Under cir-

cumstances in which differentiation between body fluid

types is difficult or impossible, all body fluids shall be

considered potentially infectious materials.

59a

(2) Engineering and work practice controls. (i) Engi-

neering and work practice controls shall be used to elimi-

nate or minimize employee exposure. Where occupational

exposure remains after institution of these controls, per-

sonal protective equipment shall also be used.

(ii) Engineering controls shall be examined and main-

tained or replaced on a regular schedule to ensure their

effectiveness.

(iii) Employers shall provide handwashing facilities

which are readily accessible to employees.

(iv) When provision of handwashing facilities is not

feasible, the employer shall provide either an appropriate

antiseptic hand cleanser in conjunction with clean cloth’

paper towels or antiseptic towelettes. When antiseptic

hand cleansers or towelettes are used, hands shall be

washed with soap and running water as soon as feasible.

(v) Employers shall ensure that employees wash their

hands immediately or as soon as feasible after removal of

gloves or other personal protective equipment.

(vi) Employers shall ensure that employees wash hands

and any other skin with soap and water, or flush mucous

membranes with water immediately or as soon as feasible

following contact of such body areas with blood or other

potentially infectious materials.

(vii) Contaminated needles and other contaminated

sharps shall not be bent, recapped, or removed except as

noted in paragraphs (d)(2)(vii)(A) and (d) (2) (vii)

(B) below. Shearing or breaking of contaminated needles

is prohibited.

(A) Contaminated needles and other contaminated

sharps shall not be recapped or removed unless the em-

ployer can demonstrate that no alternative is feasible or

that such action is required by a specific medical pro-

cedure,

60a

(B) Such recapping or needle removal must be accom-

plished through the use of a mechanical device or a one-

handed technique.

(viii) Immediately or as soon as possible after use,

contaminated reusable sharps shall be placed in appropri-

ate containers until properly reprocessed. These con-

tainers shall be:

(A) Puncture resistant;

(B) Labeled or color-coded in accordance with this

standard;

(D) In accordance with the requirements set forth in

paragraph (d) (4) (ii) (E) for reusable sharps.

(ix) Eating, drinking, smoking, applying cosmetics or

lip balm, and handling contact lenses are prohbiited in

work areas where there is a reasonable likelihood of occu-

pational exposure.

(x) Food and drink shall not be kept in refrigerators,

freezers, shelves, cabinets or on countertops or benchtops

where blood or other potentially infectious materials are

present.

(xi) All procedures involving blood or other potentially

infectious materials shall be performed in such a manner

as to minimize splashing, spraying, spattering, and genera-

tion of droplets of these substances.

(xii) Mouth pipetting/suctioning of blood or other

potentially infectious materials is prohibited.

(xiii) Specimens of blood or other potentially infec-

tious materials shall be placed in a container which pre-

vents leakage during collection, handling, processing,

storage, transport, or shipping.

(A) The container for storage, transport, or shipping

shall be labeled or color-coded according to paragraph

6la

(g)(1)(i) and closed prior to being stored, transported,

or shipped. When a facility utilizes Universal Precautions

in the handling of all specimens, the labeling/color-coding

of specimens is not necessary provided containers are

recognizable as containing specimens. This exemption

only applies while such specimens/containers remain

within the facility. Labeling or color-coding in accord-

ance with paragraph (g)(1)(i) is required when such

specimens/containers leave the facility.

(B) If outside conta

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