Opposition — Lead Industries Ass'n v. Donovan

APR 17

ALEXANCD A 7

In the Supreme Court of the United States

OCTOBER TERM, 1980

Nos. 80-1134, 80-1155 and 80-1170

LEAD INDUSTRIES ASSOCIATION, INC., ET AL.,

PETITIONERS

Vv.

RAYMOND J. DONOVAN, SECRETARY OF LABOR, ET AL.

SOUTH CENTRAL BELL TELEPHONE COMPANY, ET AL.,

PETITIONERS

Vv.

RAYMOND J. DONOVAN, SECRETARY OF LABOR, ET AL.

NATIONAL ASSOCIATION OF RECYCLING INDUSTRIES,

INC., ET AL., PETITIONERS

Vv.

SECRETARY OF LABOR, ET AL.

ON PETITIONS FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR

THE DISTRICT OF COLUMBIA CIPCUIT

MEMORANDUM FOR THE FEDERAL RESPONDENTS

WADE H. MCCREE, JR.

Solicitor General

Department of Justice

T. TIMOTHY RYAN, JR. Washington, D.C. 20530

Solicitor of Labor (202) 633-2217

BENJAMIN W. MINTZ

Associate Solicitor

DENNIS K. KADE

DIANE E. BURKLEY

Attorneys

Department of Labor

Washington, D.C. 20210

TABLE OF CONTENTS

Page

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TABLE OF AUTHORITIES

Cases:

AFL-CIO Vv. Marshall, 617 F.2d 636, cert. granted,

Nos. 79-1429, 79-1583 (Oct. 6, 1980) .................. 6

American Textile Manufacturers Institute Vv.

OE IEE EAI LY SR Oe ae 6,8

Cotton Warehouse Assoc. V. Marshall, vacated and

remanded, No. 79-1789 (Oct. 6, 1980) ................ 10

PG ee iE eeeeepreeeeeeeeereneceeeereen 10

Industrial Union Dep’t, AFL-CIO v. American

Petroleum Institute, No. 78-911 (July 2, 1980).. 5, 6,9

Statute and rule:

Occupational Safety and Health Act, 29 U.S.C.

651 et seq.:

Section 6(b), 29 U.S.C. 655(b) -....0.....0....-2.---- 2

Section 6(b) (5), 29 U.S.C. 655(b) (5) .......... 3,8

Section 6(f), 29 U.S.C. 655(f) -...00020........e 10

Gen. R. D.C. Cir. 18(d) ........ 10

Miscellaneous:

29 C.F.R.:

Section 1910.1025 (e) (1) .......cce cece ecco 8

Section 1910.1025 (f) (g) ........--2.--..ccceeeeeeeeeeeeee 4

Section 1910.1025 (kk) .2.............cc cee ecceeeeccecceeeeee 4

Section 1910.1025(k) (1) (i) (C) eee. 11

Section 1910.1025 (k) (1) (iii) (A) (8)... 1l

Miscellaneous—Continued Page

Exec. Order No. 12291, 46 Fed. Reg. 13193

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Iu the Supreme Cont of the United States

OCTOBER TERM, 1980

No. 80-1134

LEAD INDUSTRIES ASSOCIATION, INC., ET AL.,

PETITIONERS

Vv.

RAYMOND J. DONOVAN, SECRETARY OF LABOR, ET AL.

No. 80-1155

SOUTH CENTRAL BELL TELEPHONE COMPANY, ET AL.,

PETITIONERS

Vv.

RAYMOND J. DONOVAN, SECRETARY OF LABOR, ET AL.

No. 80-1170

NATIONAL ASSOCIATION OF RECYCLING INDUSTRIES,

INC., ET AL., PETITIONERS

v.

SECRETARY OF LABOR, ET AL.

ON PETITIONS FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR

THE DISTRICT OF COLUMBIA CIRCUIT

MEMORANDUM FOR THE FEDERAL RESPONDENTS

(1)

2

Petitioners seek review of the decision of the court

of appeals (Pet. App. la-286a)* that upheld in all

major respects the Secretary of Labor’s’* occupational

safety and health standard regulating employee expo-

sure to airborne concentrations of lead (29 C.F.R.

1910.1025).*

STATEMENT

1. Pursuant to Section 6(b) of the Occupational

Safety and Health Act, 29 U.S.C. 655(b), which au-

thorizes the Secretary of Labor to promulgate stand-

ards regulating employee exposure to toxic sub-

stances, the Secretary proposed in 1975 to reduce the

maximum daily permissible exposure level (PEL) for

lead from 200 to 100 micrograms of lead per cubic

meter of air (ug/m*). 40 Fed. Reg. 45934 (1975).

The Secretary did not specifically state that 50 ug/m*

was under consideration as a final PEL (ibid.), and

virtually all the technological and economic evidence

developed in the rulemaking proceeding was there-

fore addressed to the achievability of the 100 ug/m’*

proposal (Pet. App. 17la). After full rulemaking,

the Secretary enlisted the aid of private consultants.

Based on the record, these consultants drew tentative

conclusions for the Secretary’s review (id. at 38a).

Thereafter, on November 14, 1978, the Secretary pub-

lished the final standard, which set the PEL at 50

ug/m*. 43 Fed. Reg. 52952.

1“Pet. App.” refers to the appendix to the petition in

No. 80-1134.

2For convenience, we will refer to the Secretary, the

Assistant Secretary for Occupational Safety and Health, and

the Occupational Safety and Health Administration as “the

Secretary.”

The Secretary’s opinion accompanying the standard

appears at 48 Fed. Reg. 52952-53014 (1978) and 43 Fed.

Reg. 54854-54509 (1978).

3

In an opinion accompanying the final standard, the

Secretary explained that continued above-normal

blood lead levels are linked to a number of serious

neurological, renal, reproductive, and hematopoietic

(blood-forming) diseases and that reduction in air

lead levels would decrease the blood lead levels of ex-

posed employees. 43 Fed. Reg. 54854-54400 (1978).

The Secretary also found that the affected industries

could attain the 50 ug/m? level through the use of

respirators. Id. at 52977.

At the same time, the Secretary established a time

schedule whereby specified categories of affected in-

dustries would phase out general reliance on respi-

rators and conform employee exposure to the PEL

through engineering and work practice controls. 29

C.F.R. 1910.1025(e)(1). The large majority of in-

dustries were given one year to achieve compliance

with the PEL without reliance upon respirators.

Compliance periods of five to ten years were set for

five specified industries* that were thought by the

Secretary to face major obstacles in reaching the 50

ug/m*® without substantial reliance on respirators.

Ibid.

The Secretary was guided in his assessment of the

time periods required by each of these five industries

to meet the 50 ug/m* level by his interpretation of

the feasibility limitation of Section 6(b)(5) of the

Act, 29 U.S.C. 655(b) (5). Under the Secretary’s

interpretation, a standard was considered to be “feas-

ible” if technology exists or can foreseeably be devel-

oped so that “industry as a whole is able to comply,”

*Primary lead smelting, secondary lead smelting, battery

manufacturing, brass and bronze foundries, and pigment

manufacturing.

4

and if the standard does not “imperil the existence”

of the industry. 43 Fed. Reg. 54474, 54476 (1978).

The Secretary concluded that it was technically pos-

sible for these five industries to attain the PEL (id.

at 54479), but he recognized that certain industries,

notably primary and secondary lead smelting, would

have to overcome particularly intractable emission

control problems (id. at 54478-54479). Consequently,

the time schedule established by the Secretary allowed

sufficient time for each industry to implement con-

ventional control methods or to avail itself of alter-

native production processes. Ibid. The Secretary

admittedly had difficulty quantifying the costs of

attaining the PEL in these industries (and most not-

ably was unable to do so with regard to primary

smelting). Id. at 54479, 54498. However, the Secre-

tary determined that, given sufficient time, these in-

dustries possessed the financial ability to implement

necessary conventional controls or innovative proc-

esses. Id. at 54479.

‘The standard also requires that employees be tem-

porarily removed from lead-exposed jobs, without loss

of wages, if their blood lead concentrations exceed

certain specified levels. 29 C.F.R. 1910.1025(k).

These blood lead levels progressively decrease over

the first five years following the standard’s effective

date. Ibid. The cost of this program was found to

be affordable (43 Fed. Reg. 54457-54459 (1978)), a

determination that rested in part on the assumed

parallel decline in airborne lead levels simultaneously

compelled by the standard. bid.

Finally, the standard requires that the affected in-

dustries undertake a number of ancillary measures,

including periodic monitoring of airborne lead levels

and the provision of clean protective clothing. 29

C.F.R. 1910.1025(f), (g).

5

The Secretary did not undertake a formal compari-

son to determine whether there was a “reasonable

relationship” between the costs of the standard and

its benefits to employees. 43 Fed. Reg. 54431 (1978).

The Secretary rejected the view that such a “cost-

benefit” analysis must be made. Jbid.

2. The court of appeals, by divided vote, upheld

the lead standard in all major respects, but acknowl-

edged that a number of important questions on ap-

peal were “very close.” Pet. App. 9a n.6. The court

rejected petitioners’ contention that they had not re-

ceived notice that the Secretary might set a permis-

sible limit below the 100 uwg/m* standard that was

initially proposed. The court pointed out, however,

that “OSHA would have served the parties far bet-

ter,” particularly with respect to the development of

feasibility evidence for the 50 ug/m? level, “had it

listed in the proposal two or more alternative PEL’s

and invited comments on each.” Id. at 51a, 171a.

With respect to petitioners’ substantive claims, the

court concluded (Pet. App. 108a-109a) that the Sec-

retary’s finding of a need to regulate employee ex-

posure to lead was consistent with this Court’s deci-

sion in Industrial Union Dep’t, AFL-CIO v. American

Petroleum Institute, No. 78-911 (July 2, 1980). Al-

though virtually all evidence regarding the techno-

logical and economic feasibility of the permissible ex-

posure level focused on the 100 wg/m* proposal, the

court of appeals approved the Secretary’s approach

in evaluating feasivility (Pet. App. 171la-172a).

However, the court affirmed the application of the

engineering and work practice control provision as to

only ten industries. With respect to the remaining

5 These industries are: primary smelting, secondary smelt-

ing, battery manufacturing, can manufacturing, wall paper

6

industries, the court remanded for consideration by

the Secretary, with directions to return the standard

with full explanation within six months. Pet. App.

225a-226a & n.162, 246a-247a.° The court of appeals

also upheld (id. at 65a, 88a) the Secretary’s medical

removal protection provision for all industries.

Finally, on the basis of its earlier decision uphold-

ing the Secretary’s standard regulating occupational

exposure to cotton dust, the court of appeals rejected

petitioners’ contention that the lead standard was

invalid because the Secretary failed to undertake a

formal cost-benefit analysis in fixing the PEL. See

AFL-CIO v. Marshall, 617 F.2d 686 (D.C. Cir. 1979),

cert. granted, Nos. 79-1429 and 79-1583 (Oct. 6,

1980).

DISCUSSION

1. On February 17, 1981, the President issued

Exec. Order No. 12291, directing all federal agen-

cies to assess potential costs and benefits of ma-

jor regulatory proposals. See 46 Fed. Reg. 13193

(1981). In light of this directive, the Secre-

tary has determined to undertake a reexamina-

tion of both the lead and the cotton dust standards.

Thus, the Secretary issued an Advance Notice of

Proposed Rulemaking for the cotton dust standard

on March 27, 1981. 46 Fed. Reg. 19501-19503. At

the same time, the Secretary filed a supplemental

manufacturing, grey iron foundries, ink manufacturing, elec-

tronics, paints and coatings manufacturing, and painting.

The remand proceedings have been completed, and the

record was returned to the court of appeals. Thereafter, the

Secretary and certain industry parties jointly moved to hold

in abeyance further proceedings before the court of appeals

while the Secretary evaluated the industries’ petitions for

reconsideration.

T

memorandum in American Textile Manufacturers

Institute v. Donovan, Nos. 79-1429 and 79-1583 (filed

Mar. 27, 1981), which informed the Court of this ac-

tion and suggested that “the Court may wish to refrain

from further consideration of the issues now before

it in th[ose] pending cases” (Federal Respondents’

Supp. Mem. at 4).

For the same reasons, the Secretary requests that

the Court grant the petitions for certiorari in the in-

stant cases, vacate the judgment of the court below,

and order the record remanded to the Secretary for

further development. On April 17, 1981, the Secre-

tary issued an Advance Notice of Proposed Rulemak-

ing with respect to the lead standard. See Appendix,

infra. As the Advance Notice explains, the Secretary

intends to reopen the record in the lead proceeding

for the purpose of evaluating th feasibility and util-

ity of cost-benefit analysis in the standard-setting

process, comparing (if feasible) the costs and benefits

of the current (50 ug/m*) lead standard with those

of various specific alternatives, and reassessing the

current standard in light of the findings. It is the

Secretary’s view that an assessment of the practical-

ity of cost-benefit balancing is best achieved in the

context of an actual standard and in a manner that

permits public comment. Thus, the Secretary will

seek complete cost estimates for compliance with the

current permissible exposure level and other sug-

gested permissible exposure levels, as well as cost

estimates for other proposed means of providing pro-

tection to employees exposed to lead.

Petitioners contend that the Secretary, in setting

an OSHA toxic substance standard, must establish

that its costs bear a “reasonable relationship” to its

benefits (LIA Pet. 17-19; NARI Pet. 25). Petitioners

' thus seek review on an issue that will be the subject —

8

of further rulemaking. The Secretary believes that

the information, data, and comments likely to be re-

ceived through the public proceeding announced in

his Advance Notice will permit him to make an in-

formed judgment about the feasibility and utility of

cost-benefit analysis in this area. The experience

gained here and in the companion cotton dust proceed-

ing, as well as the comparative experience under other

health and safety laws (see 29 U.S.C. 655(b) (5)),

will enable the Secretary to determine the usefulness

vel non of cost-benefit analysis in setting toxic sub-

stance standards, which bears on the legality of em-

ploying that analysis in the standard setting process

because of the statutory requirement that standards

be based on the “best available evidence” (ibid.). For

these reasons, the Secretary believes that the Court

should refrain from considering the cost-benefit issue

presented by petitioners.

2. In the supplemental rulemaking proceeding, the

Secretary intends to reconsider not only the feasi-

bility and utility of cost-benefit analysis in the setting

of standards, but also the other issues presented in

these petitions. Thus, review by this Court of the

lead standard would be inappropriate at the present

time, even if the Court decides to rule on the cost-

benefit question now before it in American Textile

Manufacturers Institute v. Donovan, Nos. 79-1429

and 79-1583.

Specifically, petitioners question whether the con-

tinued economic viability of the regulated industries

is the proper test for assessing the economic feasibil-

ity of an OSHA toxic substance standard (LIA Pet.

13-14; NARI Pet. 18-23). Petitioners also challenge

the Secretary’s technological feasibility findings, par-

ticularly his reliance on innovative technology in

9

drawing his conclusions (LIA Pet. 10-13; NARI Pet.

17). The Secretary’s Advance Notice requests more

detailed information concerning such critical ques-

tions as the present state of development of relatively

recent innovations that could revolutionize such indus-

tries as primary and secondary lead smelting. The

Secretary has also requested cost estimate data for

the more innovative technology on which many of the

feasibility findings for the current lead standard

rest—data that are not currently in the administra-

tive record, but that now appear to be available.

Likewise, the Secretary has requested the most recent

information on the financia! strength and the capital

needs and structure of the affected industries. As a

result, it is possible that some of the standard’s re-

quirements will be modified to such an extent that

petitioners will no longer be aggrieved. In addition,

development of the record in these areas will cer-

tainly eliminate petitioners’ claim (LIA Pet. 21-22;

NARI Pet. 15-16) that they were afforded inadequate

notice of the PEL ultimately promulgated.’

7 South Central Bell also contends (Pet. 6-10) that ap-

plication of the lead standard to the telecommunications

industry is invalid because the Secretary failed to make

a threshold finding that this industry’s employees, whose

exposure is alleged to be infrequent, face a “significant

risk” of lead-related disease. See Industrial Union Dep't,

AFL-CIO v. American Petroleum Institute, supra, slip op.

42. The new rulemaking will specifically address the ex-

tent of risk presented by extremely intermittent exposure,

as well as the extent of exposure that employees face in the

telecommunications industry. Similarly, the other petitioners’

claim (LIA Pet. 19-21; NARI Pet. 26-27) that the medical

removal protection provision of the standard is invalid may.

be eliminated. Although the Advance Notice states that the

question of the Secretary’s statutory authority to require

medical removal protection will not be reopened, the Secre-

10

In light of the proposed supplemental proceedings,

a decision by the Court at this time would, to a sub-

stantial degree, be tantamount to an advisory opin-

ion. Cf. EPA v. Brown, 431 U.S. 99, 108-104 (1977).°

If the Secretary determines that a new lead stand-

ard should be promulgated, it is possible that no

“person who may be adversely affected by [the]

standard” will seek preenforcement review (29

U.S.C. 655(f)) in the court of appeals or in this

Court. Even if the new standard is challenged, how-

ever, some issues presented would be capable of reso-

lution only by reference to the supplemental rule-

making record.

3. Accordingly, the Secretary believes that it

would be appropriate for the Court to grant the peti-

tions for certiorari, vacate the judgment of the court

of appeals, and remand the case so that the record

may be returned to the Secretary for further consid-

eration and development. See Cotton Warehouse —

Ass’n v. Marshall, vacated and remanded, No. 79-

1789 (Oct. 6, 1980); Rule 18(d), Gen. R. D.C. Cir.

During the pendency of the proposed administra-

tive proceedings, it is the Secretary’s intention that the

lead standard now in effect (including an ambient air

tary has requested information and comments on whether the

particular “triggers” (the blood lead levels that require

employee removal) should be readjusted. Should such re-

vision occur, petitioners may decide not to seek judicial re-

view of this provision. Finally, petitioners’ challenge (LIA

Pet. 22-24) to the use of post-hearing reports prepared by

outside consultants on the feasibility of the 50 ug/m' level

is likely to be remedied by the new rulemaking proceedings.

8 Of course the Secretary’s action with respect to the lead

standard does not moot the controversy between the parties

at this time. As we have shown, however, the proposed rule-

making proceedings may obviate the need to address many of

petitioners’ current claims.

11

standard of 50 ug/m* obtained through the use of

respirators) should be left undisturbed. Lead is a

deadly toxic substance with adverse health effects

nearly as numerous as its many industrial uses. Con-

sequently, the Secretary intends to continue to en-

force the currently effective portions of the existing

standard in order to provide the necessary protection

for the employees at risk. During the past two years,

the affected industries have been required to put into

place most of the standard’s protective measures, the

major exception being the requirement that engi-

neering controls be installed.’ Completion of the lat-

ter obligation has been stayed by the court of appeals

and by this Court. There was general agreement

during the rulemaking proceeding on the necessity

for such currently effective provisions as respirator

usage, medical surveillance, and safe work practices.

It is therefore unlikely that a modified standard

would not contain these provisions.”®

*A number of employers have petitioned the Secretary to

suspend for one year the imminently effective requirement

that employees be removed from lead-exposure jobs if their

blood lead levels exceed 60 wg per 100 grams of whole blood.

29 C.F.R. 1910.1025 (k) (1) (i) (C); see 29 C.F.R. 1910.1025

(k) (1) (iii) (A) (8). The Secretary has temporarily stayed

that provision in order to consider the employers’ claim of

infeasibility.

10 There is ample precedent for preserving the status quo

in these circumstances. See Federal Respondents’ Supp.

Mem. in American Textile Manufacturers Institute v. Dono-

van, supra, at 5 n.3.

12

CONCLUSION

The petitions for a writ of certiorari should be

granted, the judgment of the court of appeals should

be vacated, and the case should be remanded with

directions to return the record to the Secretary for

further administrative proceedings.

Respectfully submitted.

WADE H. MCCREE, JR.

Solicitor General

T. TIMOTHY RYAN, JR.

Solicitor of Labor

BENJAMIN W. MINTZ

Associate Solicitor

DENNIS K. KADE

DIANE E. BURKLEY

Attorneys

Department of Labor

APRIL 1981

la

APPENDIX

[4510-26-M]

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1010

[Docket No. H-004E]

Occupational Exposure to Lead

AGENCY: Occupational Safety and Health. Adminis-

tration (OSHA), Department of Labor

AcTION: Advance Notice of Proposed Rulemaking

SUMMARY: Notice is given that the Occupational

Safety and Health Administration will shortly be

undertaking, through rulemaking procedures under

section 6 of the Occupational Safety and Health Act

of 1970, a reevaluation and reconsideration of the

occupational health standard regulating exposure to

lead, 29 CFR 1910.1025. The purpose of this pro-

ceeding is to review the technological and economic

feasibility of complying with the regulation. The eco-

nomic consequences of the regulation will be reexam-

ined on two bases. First, the affected industries’

ability to comply with the standard will be reexam-

ined. Second, a cost-benefit analysis will be per-

formed, in order to assess the practicality of relying

on this approach in setting occupational health stand-

ards in the context of a specific regulation. A paral-

lel reevaluation will be performed for the cotton dust

standard. See 46 FR 19501-19503 (March 31, 1981).

All provisions of the lead standard will be subject

to reexamination. In particular, the economic and

2a

technological feasibility of the present permissible

exposure limit of 50 micrograms of lead per cubic

meter of air (50 ug/m*) averaged over an eight-

hour day, and of the medical removal protection pro-

vision of the regulation, will be subject to analysis.

Additionally, for a few industries where employees

appear to be exposed to lead on an intermittent basis,

the question whether the employees face a significant

risk of lead-related disease will be addressed. At

this time, public participation is invited on the issues

raised by such reevaluation and as to whether other

matters relating to the hazards and regulation of

lead should be addressed.

DATES: Comments, suggestions and information are

invited regarding this Advance Notice of Proposed

Rulemaking by June 1, 1981.

ADDRESSES: Comments should be submitted to

the Docket Officer, Occupational Safety and Health

Administration, Docket No. H-004E, Room S-6212,

U.S. Department of Labor, 3rd and Constitution

Avenue, N.W., Washington, D.C. 20210.

FOR FURTHER INFORMATION CONTACT:

James Foster

Occupational Safety and Health Administration

Rm N-3637

U.S. Dept. of Labor

Wash., D. C. 20210

Telephone: (202) 523-8151

SUPPLEMENTARY INFORMATION:

1. Introduction

On October 3, 1975, the Occupational Safety and

Health Administration (OSHA) proposed a standard

for occupational exposure to lead (40 FR 45934)

3a

which would limit the maximum permissible lead ex-

posure (PEL) of employees to 100 ug/m* (micro-

grams of lead per cubic meter of air). The new

standard was to supersede the previous national con-

sensus standard which limited lead exposure to 200

ug/m*, and which had been adopted by OSHA pur-

suant to section 6(a) of the Occupational Safety and

Health Act (Act). The proposal explained that the

necessity for a more stringent and comprehensive

regulation was based on the substantial body of scien-

tific and medical evidence showing that lead has ad-

verse effects on the health of workers in the lead in-

dustry; that evidence showed that lead results in

damage to the nervous, urinary and reproductive sys-

tems, and inhibits synthesis of the molecule heme,

which is responsible for oxygen transport in living

systems. Informal rulemaking proceedings were

conducted on the proposal. On November 14, 1978, a

final standard which limited occupational exposure to

airborne concentrations of lead to 50 ug/m* based on

an 8-hour time weighted average (TWA) was pub-

lished in the Federal Register (48 FR 52952). Ad-

ditional protective provisions such as environmental

monitoring, recordkeeping, employee education and

training, medical surveillance, medical removal pro-

tection, and hygiene facilities, were included in the

standard. Supplemental attachments were published

on November 21, 1978 (43 FR 54354).

Immediately after promulgation, the lead standard

was challenged by both industry and labor groups in

the United States courts of appeals. All cases were

transferred and consolidated in the U.S. Court of Ap-

peals for the District of Columbia Circuit. On March

1, 1979, the D.C. Circuit partially stayed the lead

standard by delaying the requirement for installing

engineering controls and instituting work practices.

However, the requirement to meet the PEL using

4a

respirators, and provisions for environmental moni-

toring, recordkeeping, employee education and train-

ing, medical surveillance, and medical removal pro-

tection were not stayed and became effective on

March 1, 1979.

In an opinion issued on August 15, 1980, the court

of appeals upheld the validity of OSHA’s lead stand-

ard in most respects, acknowledging that a number of

important questions on appeal were “very close.” The

court rejected the industry petitioners’ contentions

that they had not received notice that OSHA might

set a permissible limit below the 100 wg/m* standard

that was initially proposed, and that OSHA had im-

properly relied on information not in the public rec-

ord in reaching its decisions on the standard. The

court also concluded that OSHA’s finding of a health

need to reduce the permissible lead limit was consist-

ent with the Supreme Court’s decision in Industrial

Union Dep’t v. American Petroleum Institute, No.

78-911 (July 2, 1980), which requires OSHA to show

that employees will face a “significant risk” of harm

if a new regulation is not issued. The court of ap-

peals additionally concluded that the medical removal

protection provision was authorized by the statute,

that it was reasonably necessary, and that it was af-

fordable by industry.

With respect to feasibility, the court of appeals

found that feasibility simply meant “capable of being

done,” without regard to whether the costs are justi-

fied in light of the benefits. On that basis, the court

affirmed OSHA’s finding that the following ten in-

dustries could feasibly comply with the 50 ug/m*

PEL through engineering and work practice controls:

primary smelting; secondary smelting; printing; can

manufacturing; battery manufacturing; paint and

coatings manufacturing; ink manufacturing; wall-

paper manufacturing; electronics manufacturing;

5a

and gray-iron foundries. However, the court found

that OSHA had failed to present substantial evidence

or adequate reasons to support the feasibility of the

PEL in the remaining industries, and remanded the

record to the agency for reconsideration of that issue.

The court directed OSHA to return the standard

with full explanations within six months. The court

also continued, for those industries subject to the re-

mand, the limited stay that had been in effect pend-

ing review. With respect to the ten industries for

which the standard was held fully applicable, the

stay was dissolved.

Since the issuance of the court of appeals’ August 15

decision, proceedings have taken place simultaneously

before the Supreme Court and the agency. Organi-

zations representing the primary lead smelters (Lead

Industries Association, or LIA) and the secondary

lead smelters (National Association of Recycling In-

dustries, Inc., or NARI), sought a stay pending re-

view by the Supreme Court. On December 8, 1980,

the Supreme Court granted that request in part,

notably staying for all industries the requirement

that the 50 ug/m* standard be achieved through en-

gineering and work practice controls.

LIA and NARI subsequently filed petitions for re-

view in the Supreme Court, as did the South Central

Bell Telephone Company. In their petitions, these

groups alleged that the standard is invalid on numer-

ous grounds, including lack of adequate notice; im-

proper reliance by the agency on ex parte contacts;

absence of a finding of significant risk for employees

whose exposure is only intermittent; failure by the

agency to justify the standard on a cost-benefit basis;

absence of evidence supporting the technological and

economic feasibility of reaching the 50 ug/m* PEL

in the primary and secondary smelting industries;

and lack of statutory authority for medical removal

6a

protection. The petitions are currently pending be-

fore the Supreme Court and no decision as to whether

the Court will hear the case has been issued. Con-

temporaneous with this Advance Notice, a memoran-

dum in response to the petitions is being filed with

the Supreme Court asking that the Court grant the

petitions, vacate the judgment of the court of appeals,

and remand the rulemaking record to the agency.

With regard to the remanded industries, OSHA

published a Federal Register notice on September 24,

1980 (45 FR 63476) which reopened the rulemaking

record and scheduled a hearing for the purpose of

soliciting additional information pertaining to the

technological and economic feasibility of meeting the

50 ug/m* PEL solely by engineering and work prac-

tice controls. Other issues, such as the significance of

the risk employees face in particular industries, and

the propriety of reliance on cost-benefit analysis in

setting standards, were not reopened. OSHA set time

periods for the submission of comments and notices

of intention to appear at the hearing (by October 27,

1980), and for the informal public hearing (Novem-

ber 5-7, 1980). The record remained open for the re-

ceipt of additional comment and data until December

1, and for posthearing argument until December 10,

1980.

On January 13, 1981, OSHA issued its supplemen-

tal statement of reasons with regard to the techno-

logical and economic feasibility of the PEL for 46

specified industries or occupations (46 FR 6134, Jan.

21, 1981). For most of the 46 categories, OSHA

found that the standard was feasible. For a few in-

dustry categories, OSHA found that feasible control

measures are available but that an extension in the

compliance schedule was needed to assure the feasi-

bility of their implementation. For some operations

within certain industries, OSHA found that respira-

{a

tory protection may be the only technologically feas-

ible means of compliance.

The supplemental statement of reasons was sub-

mitted to the D.C. Circuit on January 19. There-

after, because several industry groups informed the

agency of their intention to file administrative re-

quests for reconsideration of the remand decision,

OSHA and the industry petitioners jointly filed a

motion with the D.C. Circuit asking that further

judicial proceedings be held in abeyance pending the

agency’s action on the reconsideration requests. The

court has not yet acted on that motion.

The industry requests for reconsideration were filed

with the agency on February 26 and 27, 1981. The

following parties, among others, filed reconsideration

requests: LIA, the Shipbuilders Council of America,

South Central Bell Telephone Company and AT & T.

LIA has alleged that the remand proceedings were

procedurally defective. It has also asserted that the

standard is invalid due to the absence of industry-

specific findings regarding the significance of the

risk, as well as the absence of any cost-benefit or cost-

effectiveness analysis justifying the primary reliance

on engineering controls and the 50 wg/m* PEL. In

addition, LIA has alleged that the findings of eco-

nomic and technological feasibility are inadequate or

unsupported for the following seven industries or

operations: copper smelting, nonferrous foundries,

silver refining, spray painting, stevedoring, steelmak-

ing, and zine smelting and refining. The Shipbuild-

ers Council has maintained that the shipbuilding and

repair industry should be exempted from the lead

standard because: the agency failed to make adequate

findings of the technological and economic feasibility

of compliance; reliance on engineering controls is

unwarranted; and the high mobility and high turn-

8a

over of the workforce makes regulation unnecesasry

and inappropriate. South Central Bell and AT & T

have maintained the telecommunications industry

should be exempted for similar reasons.

Several industry groups (including LIA and the

Secondary Lead Smelters Association) have also re-

quested that the next “trigger” making the medical

removal provision more stringent, which was sched-

uled to go into March 1, 1981, be suspended for one

year. Beginning on March 1, the standard required

that workers be removed from high exposure areas

(with full pay) when their blood lead levels exceeded

60 ug/100g (micrograms of lead per 100 grams of

whole blood); employers are also required to keep

these workers from such exposure until their blood

lead levels had been reduced below 40 ug/100g. See

29 CFR 1910.1025(k)(1)(i)(C) and (k) (1) (iii)

(A)(3). The industry petitioners have claimed that

implementation of the 60/40 trigger will compel the

removal of skilled tradesmen in numbers that will

severely affect plant production, and will be extremely

expensive. They have suggested that OSHA’s as-

sumptions about compliance through engineering con-

trols (upon which the correlating cost calculations

for medical removal were premised), have lost all

meaning because the engineering control requirement

has been stayed since the issuance of the standard.

The agency granted a thirty-day suspension of the

trigger to study this request (46 FR 14897, March 3,

1981). OSHA has also requested additional informa-

tion from the industry petitioners. A second delay

of the effective date of the provision, until May 1,

1981, was published on March 27, 1981 (46 FR

18974).

Finally, even apart from industry’s requests for

reconsideration and stay discussed above, the agency

determined that the January 13 supplemental state-

9a

ment of reasons should be subject to review (46 FR

11254, Feb. 6, 1981).

2. Reasons for Conducting a Proposed Rulemaking

OSHA has concluded that the lead standard should

be reconsidered for several reasons. First, a new

rulemaking is appropriate because the agency has

now concluded that it sould reexamine the position,

taken in issuing the lead rule and other standards,

that it would be inconsistent with the Act for OSHA

to set a toxic substance standard on the basis of a

cost-benefit analysis. That the appropriateness of

cost-benefit analysis in the application of regulatory

policy is of vital concern to the national welfare and

the national government is evidenced by the recent

establishment of the Presidential Task Force on Reg-

ulatory Relief, chaired by the Vice-President, and

the recently issued Executive Order No. 12291 which

mandates such analysis in certain rulemaking (46

FR 18193). The policy underlying that Order is that

cost-benefit analysis is a useful device in the regula-

tory decision-making process. Other safety and

health agencies, although administering different

statutes with somewhat different purposes, have

. found that the cost-benefit technique or variants

thereof are useful in their decision making processes.

See Consumer Products Safety Commission, Proposed

Methodology for Commission Consideration of Find-

ings Under Section 9(c) of the Consumer Products

Safety Act, 45 FR 85772 (Dec. 30, 1980) ; Environ-

mental Protection Agency, National Emission Stand-

ards for Hazardous Air Pollutants; Policy and Pro-

cedures for Identifying, Assessing, and Regulating

Airborne Substances Posing a Risk of Cancer, 44 FR

58642 (1979). In consonance with the policy of the

10a

Executive Order, it is the agency’s view that it is

appropriate to evaluate the practicality of cost-benefit

balancing by investigating the concept in the context

of an actual standard such as lead, and in a manner

which permits public comment. A similar analysis

will be performed for the cotton dust standard. See

46 FR 19501-19503 (March 31, 1981).

The agency intends to invite the submission of all

information relevant to an assessment of the rela-

tionship between the rule’s benefits and its costs. In

particular, information will be sought concerning the

use of respirators as an alternative to engineering

controls. The interrelationships between the type of

economic analysis which OSHA has traditionally per-

formed and cost-benefit techniques will also be a

subject of the new rulemaking. The agency will addi-

tionally address whether, based on the cost-benefit

analysis, an individual PEL should be set for each

industry.

In the agency’s view, all this information and

data, as well as the public input which will be pro-

vided in the rulemaking proceeding, will permit the

agency to produce a comprehensive and thorough

cost-benefit analysis. This experience, plus the com-

parative experience under other health and safety

laws (a comparison mandated by 29 U.S.C. 655

(b) (5) ), will enable the agency to decide under what

circumstances it is appropriate and practical to factor

such an analysis into setting toxic substances stand-

ards.

Second, even independent of cost-benefit grounds,

the agency has concluded that it is appropriate to

reassess the technological and economic feasibility

of the 50 ug/m* standard (i.e., the industries’ abil-

ity to comply with the standard). Since no data spe-

cifically addressing the feasibility of attaining the

lla

50 wg/m* PEL was submitted at the original rule-

making, the agency’s conclusion that the 50 wg/m*

PEL was feasible was based on extrapolation from

the evidence submitted concerning the proposed 100

ug/m* PEL. The agency believes that a more com-

plete record could be developed if affected parties are

given the opportunity to specifically address the pro-

priety of a 50 uwg/m* PEL, as well as other PELs

which could be set. And while the feasibility of the

50 ug/m* PEL in the “remand” industries was ad-

dressed anew in the supplemental administrative pro-

ceedings, the affected parties have suggested that the

short time frame of that rulemaking was inadequate

to permit a proper record to be developed. More-

over, the ten industries for which the standard was

upheld in whole by the court of appeals were not

given this supplemental opportunity to submit data.

A new rulemaking proceeding will remedy these per-

ceived deficiencies. It will thereby ensure that the

standard which is ultimately set is firmly grounded

on the best available evidence.

Reevaluation of the feasibility question would ap-

pear to be particularly warranted with regard to the

primary and secondary smelting industries because

the conclusion that the present standard is feasible

for these industries was premised in part on the pos-

sibility that innovative developments in process and

control technology could contribute to significant air

lead reductions. New information concerning the

viability of these innovative technologies has now

come to the agency’s attention. For example, in the

statement of reasons to the present standard, OSHA

suggested that rather than retrofit existing pyro-

metallurgical equipment, the primary lead smelting

industry might opt to comply with the standard by

rebuilding their production facilities to utilize a new,

12a

cleaner, smelting process called hydrometallurgy.

OSHA based its prediction that the hyrometallurgical

process would be commercially available within ten

years (the time period granted the primary smelting

industry for compliance) on evidence showing that a

small scale laboratory experiment using the hydro-

metallurgical process was being conducted by the

Bureau of Mines. Since promulgation of the stand-

ard, that laboratory trial has been successfully com-

pleted, and a larger scale pilot hydrometallurgical

project has been constructed. OSHA believes that

the data which can be obtained from this larger

scale project may be useful in determining the pre-

cise extent to which hydrometallurgy can reduce

ambient lead levels.

The data from the pilot hydrometallurgical project,

as well as other new information, may also enable

the agency to quantify the predicted costs of compli-

ance with the 50 ug/m* level for the primary smelt-

ing industry. The agency believes the costs of any

standard should be estimated if it is possible to do so.

OSHA’s statement of reasons to the lead standard,

however, did not specify the dollar costs of com-

pliance for this industry. Although a quantification

of the costs of achieving compliance by innovative

technology may not have been possible at the time

the standard issued, the new data may provide the

foundation for such a calculation.

Moreover, OSHA’s review of the rulemaking rec-

ord to the original standard suggests that the data

and the formula for computing the primary smelting

industry’s costs of compliance with the 50 ug/m* PEL

using conventional controls are presently available.

No calculation was made by the agency prior to the

standard’s promulgation. Since the rulemaking rec-

13a

ord will be reopened, the agency may be able to

now compute these costs, and to subject the analysis

_ to public comment.

Similar revisions in the feasibility analysis for the

secondary lead smelting industry may be warranted.

In its statement of reasons, OSHA suggested that

rather than retrofit existing equipment, this industry

might prefer to rebuild their production facilities

using the new Bergsoe SB furnace, which was in

place in a secondary smelting facility in Sweden that

had achieved fairly low air lead levels. Industry ques-

tioned the utility of converting to the Bergsoe fur-

nace, claiming that the process will not assure the

air lead reductions necessary to achieve the PEL, and

that the 90 million dollar cost of converting to the

process is prohibitively expensive. Recent data sub-

mitted to the agency indicates that the Bergsoe fur-

nace in fact may not be responsible for the reduc-

tion in air lead levels attained in the Swedish facility.

It now appears that the air lead reductions are at-

tributable to that facility’s use of a completely inte-

grated ventilation system, and to meticulous house-

keeping and work practices. These controls are much

less expensive than the Bergsoe process; however, it

appears that the air lead levels achieved through their

use is somewhat higher than the 50 ug/m* PEL. As

with the new evidence concerning the innovative

processes in the primary smelting industry, the

agency believes it would be useful to subject this

new data to public comment, and to obtain additional

information if it exists.

Third, a new rulemaking proceeding will permit

OSHA to evaluate whether employees in industries

such as telecommunications and stevedoring, whose

exposure to lead is asserted to be intermittent, face

l4a

a “significant risk” of lead-related disease. Neither

the agency’s statement of reasons to the original

standard nor the court of appeals’ decision upholding

the agency’s significant risk finding specifically ad-

dressed this question. It is undisputed, however, that

the model correlating blood lead levels with the 50

ug/m® lead level, upon which the agency’s estimation

of risk was premised, assumed that employees would

be exposed for eight hours each workday throughout

the year. Although OSHA does not believe that an

industry-by-industry risk assessment is usually war-

ranted, the fact that lead is excreted from the body

upon removal from exposure suggests that the risk

presented by highly intermittent exposure may be

sufficiently different from that presented by chronic

exposure that separate treatment is appropriate here.

Therefore, in the new rulemaking proceeding, OSHA

intends to solicit data on the extent of risk presented

by highly intermittent exposure, and on the extent of

exposure which actually occurs in the telecommunica-

tions and stevedoring industries. Any other indus-

tries which believe they deserve separate treatment

on this basis should submit data to the agency as well.

OSHA also welcomes suggestions as to the manner

in which intermittent exposure should be treated un-

der the standard, e.g., by exempting the industries,

or by amending the standard to set a minimum num-

ber of days for which employees must be exposed

above a certain level before the compliance require-

ments of the standard will be applicable to a work-

place.

Fourth, a new rulemaking will permit the agency

to reassess the feasibility of the medical removal pro-

tection provision (MRP). As discussed above, several

industries have requested a one-year suspension of

lda

the 60/40 MRP trigger because they predict that the

trigger will compel the removal of large numbers of

skilled tradesmen and will be extremely expensive;

they also suggest that these consequences may be due

to the continuing stay of the engineering control re-

quirement of the standard. Whether or not the one-

year suspension is warranted if the present standard,

as stayed, continues in effect, (a question which the

agency is addressing separately), it is possible that if

the PEL is altered as a result of the new rulemaking

proceeding, the lower MRP triggers may have to be

adjusted as well. This is so because the feasibility

of MRP is keyed to the air lead levels present in the

workplace. Accordingly, the new rulemaking will

address the question of what adjustments if any,

should be made to the MRP triggers. The question

of the agency’s authority to require MRP, however,

will not be open in the new proceeding.

Finally, at this stage of the proceeding, OSHA will

accept and consider suggestions as to the necessity

for inquiring into other matters relevant to enforce-

ment of the standard.

3. Summary of Issues to be Addressed in the Pro-

posed Rulemaking.

In sum, OSHA invites comment or. the propriety of

conducting rulemaking on the following issues:

(1) Whether the PEL should be set at:

(a) 50 ug/m* for engineering controls;

(b) 50 ug/m* for any combination of con-

trols including respirators;

(c) 100 ug/m* for engineering controls,

combined with 50 uwg/m* for respira-

tory protection;

16a

(d) 150 uwg/m® for engineering controls,

combined with 50 ug/m* for respiratory

protection ;

(e) any other level.

(2) Whether compliance with any of the above

PELs is technologically and economically

capable of being achieved; and if so, in

what time frame.

(3) Whether highly intermittent exposure pre-

sents a significant risk of lead-related dis-

ease, and if so, how intermittent exposure

industries should be treated under the

standard. |

(4) Whether a cost-benefit analysis can be per-

formed for the lead standard; if so, how. -

(5) Whether the relationship between the costs

and benefits of any of the proposed PELs is

reasonable.

(6) Whether different PELs should be set for

different industries covered by the standard.

(7) Whether the MRP “triggers” under the

present standard are feasible; if not, what

triggers should be set.

4. Effect of the Reconsideration on Enforcement

of the Present Standard.

Pending the reconsideration discussed above, it is

the agency’s judgment that the standard, as stayed

by the Supreme Court, should remain in effect and

continue to be enforced. Specifically, all but the fol-

lowing provisions are in effect:

17a

(1) Section 1910.25(e)(1), (4), (5), (6),

which provide for compliance by engineering and

work practice controls.

(2) Section 1910.1025(e) (8), which governs

written compliance programs, except for para-

graph (F).

(3) Section 1910.1025(f) (2) (ii), which re-

lates to the use of respirators in situations in

which engineering and work practice controls

are not sufficient. During the period of the stay,

employers shall provide a powered, air-purifying

respirator in lieu of the respirator specified in

Table II of (f£)(2)(i) when the physical char-

acteristics of the employee are such that the

respirators specified in Table II are inadequate

for his or her protection. All other sections of

the regulation that refer to paragraph (f) shall

incorporate only those portions of (f) not stayed.

(4) Section 1910.1025(i), governing hygiene

facilities and practices, to the extent that it re-

quires the construction of new facilities or sub-

stantial renovation of existing facilities.

(5) Sections 1910.1025(j) (2) and (j) (8) (ii)

(D) insofar as they require biological monitor-

ing and medical examination for zinc proto-

prohyrin; and Section 1910.1025(j) (8) (iii),

which requires a multiple physician review

mechanism.

(6) Section 1910.1025(m), dealing with signs.

(7) Section 1910.1025(r), startup dates, to

the extent that its obligations are inconsistent

with the substantive requirements of this order.

18a

Protection for employees at risk must be main-

tained because lead has long been recognized as a

major industrial health hazard. During the past

several years, employers have been obligated to bring

most of the standard’s protective measures into place

with the exception of the requirement to install engi-

neering controls, which has been judicially stayed.

There was general agreement during the rulemaking

and judicial proceedings on the necessity of such pro-

visions as respiratory usage, safe work practices, and

a medical surveillance program, although the par-

ticulars may not have been resolved to the satisfac-

tion of all affected employers. The deferral of the

next major step, engineering controls, means how-

ever that there is more than sufficient time for the

agency to review the provisions of the standard as a

whole and provide adequate notice if changes to the

standard seem warranted. New effective dates may

well be necessary in such a case. Consequently, there

seems little justification for disrupting the compli-

ance schedules and activities during this period of

review. As discussed above, however; the agency is

separately addressing whether the effective date for

the 60/40 trigger should be delayed.

Any comments and suggestions should be sent to

the address noted above. Comments should be sub-

mitted by June 1, 1981.

5. Authority.

This document was prepared under the direction of

Thorne G. Auchter, Assistant Secretary of Labor for

Occupational Safety and Health, 200 Constitution

19a

Avenue, N.W., Washington, D.C. 20210. It is issued

pursuant to section 6(b) of the Occupational Safety

and Health Act (84 Stat. 1598; 29 U.S.C. 655).

Signed at Washington, D.C. this 14 day of April

1981.

THORNE G. AUCHTER

Assistant Secretary of Labor

W ov. Ss. coveenment printing orrice; 1961 344828 314