Amicus Curiae Brief — Dole v. Steelworkers

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In THE =

Supreme Court of the United States

OCTOBER TERM, 1988

ELIZABETH DOLE, Secretary of Labor, et al.,

2 Petitioners

UNITED STEELWORKERS OF AMERICA, et al.

On Writ of Certiorari to the United States Court of Appeals

for the Third Circuit

BRIEF OF THE

NATIONAL WHOLESALE DRUGGISTS’ ASSOCIATION

AS AMICUS CURIAE IN SUPPORT OF PETITIONERS

LAWRENCE W. BIERLEIN

(Counsel of Record)

PAUL A. GAUKLER

SHAW, PITTMAN, PoTTs &

TROWBRIDGE

2300 N Street, N.W.

Washington, DC 20037

(202) 663-9245

RONALD J. STRECK

Vice President Government Affairs

National Wholesale Druggists’

Association

105 Oronoco Street

Alexandria, VA 22313

(703) 684-6400

WILSON - Epes Printinc Co., Inc. - 789-0096 - WASHINGTON, D.C. 20001

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5 La

TABLE OF AUTHORITIES

INTEREST OF AMICUS CURIAE

STATEMENT OF FACTS

SUMMARY OF ARGUMENT

ARGUMENT .....................

Il.

III.

CONCLUSION

TABLE OF CONTENTS

eee eee P rr errr ee ee Pere Pe er err)

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BY THE TERMS OF THE PAPERWORK

REDUCTION ACT AND THE OMB REG-

ULATIONS IMPLEMENTING IT, THE

OSHA STANDARD AS APPLIED TO FDA-

REGULATED DRUGS WAS SUBJECT TO

OMB REVIEW AND DISAPPROVAL...............

THE THIRD CIRCUIT’S REFUSAL TO AC-

KNOWLEDGE THE OMB REGULATIONS

WAS REVERSIBLE ERROR |...

THE THIRD CIRCUIT OPINION ERRONE-

OUSLY CONFUSED THE EFFECT AND IM-

PORT OF THE OMB ACTION WITH RE-

GARD TO OSHA’S GENERAL EXEMPTION

OF FDA-REGULATED DRUGS

mR OR me eee ree

TABLE OF AUTHORITIES

Cases: Page

Aluminum Co. v. Central Lincoln People’s Utility

District, 467 U.S. 386 (1984) —..........02............. 11

American Paper Institute, Inc. v. American Elec-

tric Service Corp., 461 U.S. 402 (19838) .............. 11

Batterton v. Francis, 482 U.S. 416 (1977) ............ 12

Blum v. Bacon, 457 U.S. 182 (1982) ....................... 11

Chevron, U.S.A., Inc. Vv. Natural Resources De-

fense Council, Inc., 467 U.S. 887 (1984) .......... 11

E.I. duPont de Nemours & Co. v. Collins, 482 U.S.

GB CRT UD neneceecccccecscesesessenseretesnnnsaaneee 10

NLRB v. Bell Aerospace, Inc., 416 U.S. 265

CHER ...nncannte ; 12

Red Lion Broadcasting Co. v. FCC, 395 U.S. 367

CRG) ceecerscerssserssssnsnnsnnisinninnaan 11, 12

Udall v. Tallman, 380 U.S. 1 (1965) ....................... 11

Unemployment Compensation Comm’n V. Aragan,

829 U.S. 148 (1946)... Peer nee ere 11

United States v. Morton, 467 U.S. 822 (1984) ........ 12

United Steelworkers, et al. v. Pendergrass, et all.,

855 F.2d 108 (8d Cir. 1988) W000... 2, 5, 13

Young v. Community Nutrition Institute, 476 U.S.

At | enn 12

Statutes :

Fodd, Drug, and Cosmetic Act, 21 U.S.C. 301,

CB BBB. <.-~crccccncrrensssnssennnsetonnseamennsnnea 2,3

Paperwork Reduction Act, 44 U.S.C. 3501, et seq...passim

Occupational Safety & Health Act, 29 U.S.C. 651,

CB Be 5.eeeceeceeececcosnseseussvsnsensstenennseeeneeee 6

Regulations: |

Controlling Paperwork Burdens on the Public, 5

oe A 3 passim

Food & Drug Administration “labeling,” 21 C.F.R.

| pee aii 3

Hazard Communication Standard, 29 C.F.R.

BORO TBO ccccecwscevccesessccovnnsussnunnenienssianeneennanennn passim

iii

TABLE OF AUTHORITIES—Continued

Reports: Page

S. Rep. No. 96-930, 96th Cong., 2d Sess., 40; Re-

printed in 1980 U.S. Code Cong. & Admin. News

a ermnenees 12

S. Rep. No. 98-576, 98th Cong., 2d Sess. (1984)... 12

Other Authorities:

Physician’s Desk Reference (42d Edition, 1988,

Medical Economics Co., Inc., Oradell, NJ

EA 3, 8,9

Facts and Comparisons (Looseleaf Drug Informa-

tion Service, J.B. Lippincott Co., St. Louis, MO

EEE 3, 8,9

USP Dispensing Information (9th Ed., 1989,

United States Pharmacopeial Convention, Inc.,

EE 3, 8, 10

IN THE

Supreme Court of the United States

OCTOBER TERM, 1988

No. 88-1434

ELIZABETH DOLE, Secretary of Labor, et al.,

7 Petitioners —

UNITED STEELWORKERS OF AMERICA, et al.

On Writ of Certiorari to the United States Court of Appeals

for the Third Circuit

BRIEF OF THE

NATIONAL WHOLESALE DRUGGISTS’ ASSOCIATION

AS AMICUS CURIAE IN SUPPORT OF PETITIONERS

INTEREST OF AMICUS CURIAE

The National Wholesale Druggists’ Association

(NWDA) files this brief with the consent of the

parties.

NWDA is an association of businesses engaged in

the wholesale distribution of prescription and over-

the-counter medicines and consumer products. Its

membership includes drug wholesale companies op-

erating drug distribution centers nationwide. Each

distribution center has an average of 400 pharmacy

customers, and distributes approximately 12,000 in-

dividual FDA-regulated drugs that appear to be sub-

ject to the Hazard Communication Standard (29

C.F.R. 1910.1200), implemented by the Occupational

Safety & Health Administration (OSHA) of the De-

partment of Labor.

NWDA’s members are regulated under the OSHA

standard through two particular provisions: 29

C.F.R. 1910.1200(b) (4), which discusses work op-

erations where employees only handle chemicals in

sealed containers which are not opened under normal

conditions of use, and 29 C.F.R. 1910.1200(g) (7),

which describes the duty of distributors to ensure that

Material Safety Data Sheets (MSDSs) and updated

information are provided to other distributors and

employers. Even when only sealed containers are

handled, MSDSs that are received by the wholesaler

must be maintained and must be made accessible to

— under paragraph (b) (4) (ii) of the stand-

ard.

Products of particular concern to NWDA members

are drugs regulated by the Food & Drug Administra-

tion (FDA) under the Food, Drug, and Cosmetic Act,

21 U.S.C. 301, et seg. The employers to whom these

drugs are distributed are hospital, retail, and nursing

home pharmacies.

Although not a party in the Third Circuit litiga-

tion below (855 F.2d 108 (3d Cir. 1988)), NWDA

has participated extensively in the administrative and

hearing stages of the OSHA rulemaking, as well as

in the review of that rulemaking by the Office of

Management & Budget (OMB) under the Paperwork

Reduction Act, 44 U.S.C. 3501, et seg. It was in part

on the basis of NWDA’s testimony at the public hear-

ing of October 16, 1987, that OMB disapproved ap-

plication of the OSHA standard to FDA-regulated

drugs (Petition for Certiorari, p. 37a).

STATEMENT OF FACTS

FDA-regulated drugs are subject to substantial

warning information requirements in the form of

product labeling under the Food, Drug, and Cosmetic

Act, supra. Data about new drug products are re-

viewed by FDA scientists, including pharmacologists

and toxicologists, to assure that each drug is safe and

effective for the indicated use with the patient and

for the administering professional pharmacist, physi-

cian, and nurse.

FDA-required labeling under 21 U.S.C. 321 in-

cludes separate written sheets called “professional

package inserts” (21 C.F.R. 1.3), one of which must

be in each package. This information provides de-

tails of the product chemistry and its hazards. In

addition, information from product labels and profes-

sional package inserts is compiled and published

verbatim in commonly available texts as the Physi-

cians’ Desk Reference (42d Edition, 1988, Medical

Economics Co., Inc., Oradell, NJ 07649), Facts and

Comparisons (Looseleaf Drug Information Service,

J.B. Lippincott Co., St. Louis, MO 63146-3098), and

USP Dispensing Information (9th Ed., 1989, United

States Pharmacopeial Convention. Inc., Rockville, MD

20852).

FDA-regulated drugs are exempt from OSHA

labeling under 29 C.F.R. 1910.1200(b) (5) (ii). In

addition, the standard as expanded to include non-

manufacturers offers a complete general exemption

for “Any drug, as that term is defined in the Fed-

eral Food, Drug, and Cosmetic Act (21 U.S.C. 301,

et seq.), when it is in solid, final form for direct

administration to the patient (i.e. tablets or pills) ,”

29 C.F.R. 1910.1200(b) (6) (viii). Due to the phras-

ing of this general exemption and its limitation to

tablets and pills, the drug wholesaler remains obli-

gated to maintain and to distribute MSDSs to phar-

macies for FDA-regulated products in capsule, in-

jection bottle, liquid, and other physical forms.

NWDA has estimated that each of its members’

310 distribution centers would have to retain 12,000

MSDSs and to pass on 4.8 million copies of those

MSDSs (400 customers times 12,000 products). Based

upon this burden, plus the present availability of de-

tailed FDA-required chemical and hazard information

in the form of professional package inserts and refer-

ence texts, and in light of the specialized knowledge

of the professional employee audience, OMB disap-

proved the OSHA standard under the Paperwork Re-

duction Act as the standard applies to all FDA-

regulated drugs. (OMB letter to Thomas Komarek,

Oct. 28, 1987; Petition for Certiorari, Appendix E,

p. 22a.) OMB found that “coverage of any FDA-

regulated drug would result in duplicative paperwork

and is unlikely to provide additional information of

any practical utility.” (Jd., p. 37a.)

SUMMARY CF ARGUMENT

The Paperwork Reduction Act, 44 U.S.C. 3501,

et seq., is intended to minimize the Federal paperwork

burden for individuals, small businesses and other

persons. This statute vests the Director of OMB with

certain specific review and approval functions with

regard to recordkeeping, reporting, and paperwork

required by federal agencies.

~ The OSHA hazard communication standard, as ap-

plied to FDA-regulated drugs, imposes an extremely

burdensome and unnecessary paperwork redundancy

through obligations upon FDA-drug wholesalers and

pharmacists to obtain, distribute, retain, and update

Material Safety Data Sheets for prescription medi-

cines already covered by FDA paperwork require-

ments. Under OMB regulations, as well as the words

of the Paperwork Reduction Act, burdens such as

these are included in the information collection review

process. OMB, in an appropriate hearing, found the

general exemption for drugs offered in the OSHA

standard to be inadequate because it was limited to

pills and tablets and, therefore, OMB disapproved the

standard as it would apply to any FDA-regulated

drugs.

On Supreme Court review of the decision in United

Steelworkers, et al. v. Pendergrass, et al., 855 F.2d

108 (3d Cir. 1988), we ask the Court to find that the

Third Circuit Court of Appeals erred—

(1) in concluding that the Paperwork Reduc-

tion Act is inapplicable to the paperwork bur-

dens imposed by the OSHA standard;

(2) in ignoring the OMB regulations imple-

menting the Paperwork Reduction Act, which

explicitly declare this type of paperwork burden

to be encompassed by the review process; and

(3) in misinterpreting the intent and effect of

the OMB action as it pertains to FDA-regulated

drugs.

ARGUMENT

I. BY THE TERMS OF THE PAPERWORK REDUC-

TION ACT AND THE OMB REGULATIONS IM-

PLEMENTING IT, THE OSHA STANDARD AS

APPLIED TO FDA-REGULATED DRUGS WAS SUB-

JECT TO OMB REVIEW AND DISAPPROVAL.

The first purpose of the Paperwork Reduction Act,

supra, is “to minimize the Federal paperwork burden

for individuals, small businesses, State and local gov-

ernments, and other persons.” 44 U.S.C. 3501(1).

An additional purpose expressed in the statute is “to

coordinate, integrate and, to the extent practicable

and appropriate, make uniform Federal information

policies and practices.” 44 U.S.C. 3501(4)*. One of

the functions of the OMB Director is to “provide di-

rection and oversee the review and approval of in-

formation collection requests” as well as “the reduc-

tion of the paperwork burden.” 44 U.S.C. 3504(a).

Section 3504(b), defining the Director’s authority

and functions, includes the responsibility to review

government agencies’ information collection proposals.

Section 3508 of the Paperwork Reduction Act

states:

Before approving a proposed information col-

lection request, the -Director shall determine

whether the collection of information by an

agency is necessary for the proper performance

of the functions of the agency, including whether

* The interagency coordinating role for the OMB Director,

defined in paragraph (4) of the purpose section of the Paper-

work Reduction Act, is consistent with Section 4(b) (1) of

the Occupational Safety & Health Act, 29 U.S.C. 653(b) (1),

which declares that OSHA standards shall not apply “to

working conditions of employees with respect to which other

Federal agencies . . . exercise statutory authority to prescribe

or enforce standards or regulations affecting occupational

safety or health.”

the information will have practical utility. .. .

To the extent, if any, that the Director deter-

mines that the collection of information by an

agency is unnecessary, for any reason, the

agency may not engage in the collection of the

information.

The Paperwork Reduction Act defines “collection

of information” to include “the soliciting of facts or

opinions by an agency through the use of written

report forms, application forms, schedules, question-

naires, reporting or recordkeeping requirements, or

other similar methods. . . .” 44 U.S.C. 3502(4). The

term “information collection request’ is defined in

subparagraph (11) of that section to mean “a written

report form, application form, schedule, questionnaire,

reporting or recordkeeping requirement, collection of

information requirement, or other similar method

calling for the collection of information.” Subpara-

graph (17) defines “recordkeeping requirement” as

“a requirement imposed by an agency on persons to

maintain specified records.”

Under the OSHA hazard communication standard,

NWDA’s members are obligated to maintain MSDSs

that are received and to keep them accessible for in-

spection by employees and by OSHA compliance offi-

cers. All MSDSs that are received, in addition, must

be duplicated and distributed to all pharmacist cus-

tomers. This federal obligation is a reporting, rec-

ordkeeping, and collection of information requirement.

OMB’s rules generally note that a proposed collec-

tion of information will not be approved “requiring

respondents to maintain or provide information in

a format other than that in which the information is

customarily maintained.” 5 C.F.R. 1320.6(j).

Chemical information about FDA-regulated drugs

is customarily maintained in FDA-required labeling,

including printed professional package inserts. It is

not customarily maintained by the non-manufacturing

wholesaler or pharmacy on MSDS forms. Examples

of such package inserts as well as the detailed FDA-

required information reproduced in texts such as the

Physicians’ Desk ay va and os

SP Di ing Information, supra, -

~~ in Past ty the NWDA Testimony Before

the Federal Office of Management & Budget, October

16, 1987, which is part of the OMB administrative

record. The insert goes into or is affixed to each

package, and wholesalers, pharmacists and other peo-

ple who use this information regularly maintain

copies of the bound texts. Through this existing FDA

system, effective hazard communication involving

labeling, paperwork and training is in place. The in-

formation found on a typical MSDS is much less

specific, and less effective as a communication to a

pharmacist whose training is based upon the style of

FDA labeling and professional package insert infor-

mation. The data in a professional package insert

differs somewhat in format from an OSHA MSDS,

but it conveys essentially the same information. This

different format carries the benefit of being more

familiar to the specific audience for which it has been

prepared—the same audience of distribution, phar-

macy and medical employees as that targeted by the

OSHA hazard communication standard.

Section 3516 of 44 U.S.C. mandates that the OMB

Director “promulgate rules, regulations, or procedures

necessary to exercise the authority provided by this

chapter.” Section 1320.7(c) of OMB’s regulations

defines the “collection of information” as the obtain-

ing or soliciting of information, and goes on to define

such solicitation as including “any requirement or

request for persons to obtain, maintain, retain, re-

port, or publicly disclose information.” “Subparagraph

Requirements by an agency or a person to

obtain or compile information for the purpose of

disclosure to members of the public or to the

public at large, through posting, notification,

labeling, or similar disclosure requirements, con-

stitute the “collection of information” when-

ever the same requirement to obtain or compile

information would be a “collection of informa-

tion” if the information were directly provided

to the agency. ...

This definition section also states explicitly that

““*[r]ecordkeeping requirement’ . . . includes require-

ments that information be maintained or retained by

persons but not necessarily provided to an agency”

(5 C.F.R. 1320.7(r)), and that “‘[rJeporting re-

quirement’ means a requirement imposed by an

agency on persons to provide information to another

person or to the agency” (5 C.F.R. 1320.7(s)) (Em-

phasis supplied. )

Typical MSDSs fill several pages. Using NWDA’s

estimates drawn from its own membership, each

distribution center services an average of 400 cus-

tomers with a universe of 12,000 affected products

that would require MSDSs. (Approximately 4,000

drug wholesalers operate in the U.S., not all of whom

are represented by NWDA, but all of whom are fac-

ing this crisis.) If each MSDS were 4 pages long,

each NWDA member’s distribution center would

have to duplicate and distribute an average of 19.2

million sheets of paper to customers who already

have virtually the same information in a different

format in their Physicians’ Desk Reference, Facts

and Comparisons, or USP Dispensing Information,

supra. - |

This is exactly the type of duplicative and useless

burden the Paperwork Reduction Act was designed

to curtail. That MSDSs for each product need not

be filed directly with OSHA is irrelevant—they are

required of all employers by a government agency in

a specific format with specific entries as records to

be obtained, retained, distributed and updated. This

paperwork also must be available for inspection by

employees and government compliance officers. The

Congressional concern addressed by the Paperwork

Reduction Act was the burden on the people who are

required to complete federal paperwork. The identity

or address of the recipient in no way lessens the

burden suffered by any business needlessly compelled

to copy and distribute millions of sheets of paper that

substantially repeat what is already on every re-

cipient’s shelf.

ll. THE THIRD CIRCUITS REFUSAL TO ACKNOWL-

EDGE THE OMB REGULATIONS IS REVERSIBLE

ERROR.

The OMB regulations in 5 C.F.R. Part 1320 im-

plementing the Paperwork Reduction Act unques-

tionably describe the paperwork burden imposed

upon NWDA’s members and others by the expanded

OSHA standard. However, in holding that the OSHA

standard does not involve “collection of information”

under the Paperwork Reduction Act, the Third Cir-

cuit did not even acknowledge the existence of these

rules despite the fact that the rules were discussed

extensively in the government’s brief to that court.

This is inexplicable. It is well established that “the

construction of a statute by those charged with its

execution should be followed unless there are com-

pelling indications that it is wrong... .” E.I. duPont

de Nemours & Co. v. Collins, 482 U.S. 46, 54-55

(1977) (quoting Red Lion Broadcasting Co. v. FCC,

395 U.S. 367, 381 (1969). This Court has stated:

“We have often noted that the interpretation of

an agency charged with the administration of a

statute is entitled to substantial deference.”

Blum v. Bacon, 457 U.S. 132, 141 (1982). “To

uphold [the agency’s interpretation] ‘we need

not find that [its] construction is the only rea-

sonable one, or even that it is the result we would

have reached had the question arisen in the first

instance in judicial proceedings.’ .. . We need

only conclude that it is a reasonable interpreta-

tion of the relevant provisions.” American Paper

Institute, Inc. v. American Electric Service

Corp., 461 U.S. 402, 422-423 (1983), quoting

Unemployment Compensation Comm’n vy. Ara-

gan, 329 U.S. 143, 153 (1946).

Aluminum Co. v.'Central Lincoln People’s Utility

District, 467 U.S. 386, 389 (1984). Accord, Udall v.

Tallman, 380 U.S. 1, 16 (1965) (deference is par-

ticularly due to an administrative interpretation in-

volving “a contemporaneous construction of a statute

by the men charged with the responsibility of setting

its machinery in motion’”’).

Moreover, the deference owed the agency’s inter-

pretation takes on particular significance when that

interpretation is embodied in legislative-type regula-

tions promulgated pursuant to a grant of authority

such as that found in 44 U.S.C. 3516. Agency legis-

lative regulations implementing its enabling legisla-

tion have the force and effect of law and are entitled

to great weight. Unless the regulation embodies a

construction of the statute “contrary to clear con-

gressional intent,” a court “may not substitute its

own construction of a statutory provision for a rea-

sonable interpretation made by the administrator of

an agency.” Chevron, U.S.A., Ine. v. Natural Re-

sources Defense Council, Inc., 467 U.S. 837, 842-45

(1984). See also, United States v. Morton, 467 U.S.

822, 834 (1984) (“[b]ecause Congress explicitly dele-

gated authority to construe the statute by regulation,

in this case we must give the regulators legislative

and hence controlling weight unless they are arbi-

trary, capricious or plainly controry to the statute”) ;

accord, Batterton v. Francis, 4382 U.S. 416, 424-426

(1977).

Here, the OMB regulations are plainly consistent

with Congress’ intent. The Senate Report on the

Paperwork Reduction Act expressly states that the

definition of “recordkeeping requirement” as found

in that Act “includes information maintained by

persons which may be but is not necessarily provided ,

to a Federal agency.” S. Rep. No. 96-930, 96th Cong.,

2d Sess. 40, Reprinted in 1980 U.S. Code Cong. &

Admin. News 6241, 6280. Moreovese in considering

amendments to the Act in 1984, Congress was aware

of OMB’s construction of the Act found in its regu-

lations, and took no steps to alter that construction.

See, S. Rep. No. 98-576, 98th Cong., 2d Sess. (1984).

“C]longressional failure to revise or repeal [an]

agency’s interpretation is persuasive evidence that

the interpretation is the one intended by Congress.”

Young v. Community Nutrition Institute, 476 U.S.

974, 983 (1986), quoting NLRB v. Bell Aerospace,

Inc., 416 U.S. 267, 275 (1974). Accord, Red Lion

Broadcasting, supra, 395 U.S. at 381-382.

Thus, the Third Circuit committed manifest error

in refusing to acknowledge, much less discuss and

analyze, OMB’s regulations implementing the Paper-

work Reduction Act that are clearly on point.

Ill. THE THIRD CIRCUIT OPINION ERRONEOUSLY

CONFUSED THE EFFECT AND IMPORT OF THE

OMB ACTION WITH REGARD TO OSHA’S GEN-

ERAL EXEMPTION OF FDA-REGULATED DRUGS.

It is important to note the Court of Appeals’ ap-

parent misunderstanding of the action taken by OMB

with regard to FDA-regulated drugs. Although a

labeling exemption has existed and was continued in

the OSHA standard for consumer products and FDA-

regulated drugs, a new general exemption was cre-

ated, but only for ‘a limited number of consumer

products and FDA-regulated pills and tablets. OMB’s

disapproval did not’ criticize the new general ex-

emptions because they were unwarranted, as the

Third Circuit implies, but because they did not go

far enough. OMB found that MSDS requirements on

FDA-regulated drugs are grossly burdensome for dis-

tributors and pharmacists, duplicative of existing

paperwork, and of little utility to anyone. The Third

Circuit, however, appears to have confused the label-

ing and general types of exemption, and seriously

misstated the OMB position:

Whatever else the terms “collection of infor-

mation” or “information collection requests” may

refer to, they cannot possibly refer to these ex-

emptions from labeling requirements imposed in

the interest of health and safety by other federal

regulatory agencies.

55 F.2d 108, 112.

As a result of the confusion, the court passed over

the FDA issue and devoted the bulk of its opinion

only to the substantially different multi-employer

worksite issue. The court closed its opinion by de-

claring the general exemptions to be a “logical out-

growth” of the original administrative record, but

again appeared to misconstrue OMB’s disapproval as

destroying those exemptions rather than being a

finding of insufficient breadth, OMB declared the

standard unenforceable with regard to all FDA-regu-

lated drugs. The standard may have been expanded

pursuant to court order but, as noted in 5 C.F.R.

1320.4(c)(1), the Director “will independently as-

sess any collection of information to the extent that

the agency exercises discretion in its implementa-

tion.” The creation of general exemptions was a

“logical outgrowth” of the record within OSHA’s

discretion and was appropriate for OMB review.

CONCLUSION

For the foregoing reasons, the Third Circuit de-

cision with regard to the OMB disapproval under the

Paperwork Reduction Act of any OSHA coverage of

FDA-regulated drugs should be reversed.

Respectfully submitted,