Joint Appendix — Dole v. Steelworkers

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ELIZABETH DOLE, SECRETARY OF LABOR, ET AL.,

PETITIONERS

UNITED STEELWORKERS OF AMERICA, ET AL.

ON WRIT OF CERTIORARI TO THE UNITED STATES

COURT OF APPEALS FOR THE THIRD CIRCUIT

JOINT APPENDIX

Washington, D.C. 20005

(202) 633-2217

Counsel for Petitioners

MAURICE BASKIN

Venable, Baetjer, Howard &

Civiletti

1301 Pennsylvania Ave., N.W.

Suite 1200

Washington, D.C. 20004

(202) 662-4300

Counsel for Respondents

Supporting Petitioners

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Jn the Supreme Court of the Gnited States

OCTOBER TERM, 1988

No. 88-1434

ELIZABETH DOLE, SECRETARY OF LABOR, ET AI

PETITIONERS

Vv.

UNITED STEELWORKERS OF AMERICA, ET Al

ON WRIT OF CERTIORARI TO THE UNITED STATES

COURT OF APPEALS FOR THE THIRD CIRCUIT!

JOINT APPENDIX

INDE X*

Page

Chronological List Of Relevant Docket Entries . |

The Department of Labor’s Hazard Communica-

tion Standard (29 C.F.R. 1910.1200) .......... a)

Excerpts From “Hazard Communication: Notice of

Proposed Rulemaking” (47 Fed. Reg. 12,092

en ees 36

Excerpts From “Hazard Communication: F inal

Rule (48 Fed. Reg. 53,280 (Nov. 25, 1983))..... 38

* The opinion and judgment of the court of appeals, the denial of

petitions for rehearing, the Oftice of Management and Budget’s disap-

proval of certain provisions of the hazard communication standard,

and related correspondence have been reproduced in the petition for

writ of certiorari. The materials reproduced herein, which are not

“parts of the record” (Sup. Ct. R. 30.1), have been reproduced by

agreement of the parties tor the convenience of the Court

(1)

INDEX — Continued:

Excerpts From “Hazard Communication: Final

Rule” (52 Fed. Reg. 31,853 (Aug. 24, 1987)) ....

Excerpts From “Hazard Communication: Notice of

Proposed Rulemaking” (53 Fed. Reg. 29,822

(Ang. &, IGGRD ... 0s cccccccedennnee

Order Of The Supreme Court Granting The Writ

Of Cortiovard ......scecseceusuaeee

Page

104

Chronological List Of Relevant Docket Entries

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

Nos. 83-3554, 83-3562 & 83-3565

84-3066, 84-3093 & 84-3128

UNITED STEELWORKERS OF AMERICA, PETITIONER

JOHN A. PENDERGRASS, ASSISTANT SECRETARY

OF LABOR, ETC., RESPONDENT

Pustic CITIZEN, INC., ET AL., PETITIONER

Vv.

JOHN A. PENDERGRASS, ASSISTANT SECRETARY

OF LABOR, ETC., RESPONDENT

[Docketed Nov. 22, 1983]

DATE FILINGS — PROCEEDINGS

1985

» * * * *

May 24. Judgment granting in so far as stated below.

Fytther ordering & Adjudging the Hazard

ommunication Standard to the extent that

t is valid, et al. Further ordering & adjudg-

ing that the Sec’s rejection to the RTECS list

overinclusive is supported by substantial

evidence, consistent w/the OSH’

(1)

DATE

1987

Jan. 27

FILINGS — PROCEEDINGS

statutory purpose, & is therefore valid. Fur-

ther order & adjudged that the definition of

trade secrets, which is broader than the pro-

tection afforded trade secrets by state law, is

invalid & the Sec. is directed to reconsider a

trade secret, et al. It is further ordered & ad-

judged that the trade secret access rule in the

standard is invalid insofar as it limits access

to health professionals, but is otherwise

valid, & the Sec. is directed to adopt a rule

permitting access by employees & their col-

lective bargaining representatives. All the

above in accordance with the opinion of this

Court. filed (cvs 83-3554 83-3561 83-3565

84-3066 84-3093 & 84-3128) (sa)

* * * * *

Mot. by petitioners requesting that this Ct.

dir. the Sec., within two weeks of this Ct.’s

action, (a) to order extension of the Hazard

Communication Standard to all employers

cvd. by the OSH Act —& to set the effective

date of the amendment no more than ninety

days after its announcement, see 29 U.S.C.

§ 655(b)(4) — or (b) to state why such exten-

sion is infeasible. In addition, petitioners

ask the Ct. to hold the Sec. in civil contempt

for failing to comply with the Ct.’s earlier

judgment. In view of the importance of this

case and the issues raised by the instant

mot., petitioners further request that the Ct.

schedule oral argument on petitioners’ mot.

DATE FILINGS — PROCEEDINGS

Mar.

May

w/serv. filed (cvs. 83-3554, 83-3561,

83-3565, 84-3066, 84-3093 & 84-3128) (sa)

~ * * ~ *

23 Heard on pet. of United Steelworkers of

America for further relief w/respect to prior

dec. of this Court. Coram: Gibbons, ChJ,

Fisher & Kelly, DJ At the hearing cnsl for

resp. requested permission to have

transcript prepared of oral argmt. & Ct.

granted permission. (Cvs. 83-3554, 3561,

3565, 84-3066, 3093 & 3128) (ab)

pe ee i

29 = Opinion of the Court (Gibbons, Chief Judge

Fisher, Chief Judge* and Kelly, District

Judge**) filed (cvs. 83-3554, etc.) *Hon.

Clarkson S. Fisher, Chief Judge; U.S. Dist.

Ct. for the Dist. of NJ sitting by designa-

tion.** Hon. James M. Kelly, U.S. Dist. Ct.

Judge for the Eastern District of PA sitting

by designation. (sa)

29. +=Orders granting the mot. which has been

treated as a pet. for -eview for further relief

with respect to this Ct’s prior dec. in United

Steelworkers v. Aucher, 763 F.2d 728 (3d

Cir. 1985) and the Sec. is directed, within 60

days frm. the date of this order to publish in

the Fed. Register a hazard communication

standard applicable to all wrks. covd. by the

OS & H Act of 1970, including those which

have not been cvd. in the hazard com-

munication standard as presently written, or

a Statement of reasons why, on the basis of

DATE FILINGS — PROCEEDINGS

the present administrative rec., a hazard

communication standard is not feasible.

Further ordering that if such a statement of

reasons is fld. reasons shall be supplied

separately as to each category of excluded

workers. Denying at this time the petition

insofar as petitioners seek to have the re-

spondents held in contempt. (cvs 83-3554,

etc.) (Sa)

* * ~ * *

Jul 23 Emergency Motion by Secretary of Labor to

Stay Further Proceedings, filed. w/service.

(cvs. 83-554, etc.) (ch)

* * * * *

Aug 12 Order (Gibbons, Chief Judge and Fisher and

Kelly, District Judges) denying Emergency

mot. by Sec. of Labor to stay further pro-

ceedings. fld. (cvs 83-3554, etc.) (sa)

* » * * *

Aug 31 Certified judgment in lieu of a formal man-

date issued fld (cvs. 83-3554, etc.

* ” * » a

1988

Apr. 6 Mot. by petitioners for further relief w/respect

to prior dec. of this Ct. & points and

authorities in support thereof. w/serv fld

(cvs 83-3554 etc

Apr. 6 Mot. by petitioners to add James C. Miller III,

Dir. Office of management and budget as

respondent. (Covs. 83-3554, ect.) filed

w/serv. (Sa)

DATE

Aug. 10

Aug. 19

Sept. 2

FILINGS — PROCEEDINGS

Submitted on motion for further relief.

Coram: Gibbons, Ch.J., Fisher & Kelly, DJ

(covers 83-3554, 3561, 3565 & 84-3066, 3093

& 3128) (ab)

Opinion of The Court (Gibbons, Chief Fisher*

and Kelly* District Judges) sitting by

designation. filed (cvs. 83-3554, etc.) (sa)

Order (Gibbons, Chief Judge Fisher & Kelly,

District Judges*) Denying mot for a stay of

hazard communication standard pending-

resolution of pet. for review etc. Petition for

review denied for the reasons set forth in

opn. addressing the mot. of U.S.

Steelworkers of America, etc. for further

relief. filed (cvs 83-3554, etc.) *Sitting by

designation. (sa)

Order ordering & adjudging by this Ct. that

Sec. shall forthwith publish in the Fed.

8/24/87 hazard communication standard

which were disapproved by Off. Manage-

ment, are now effective. Denying peti-

tioners’ mot. to hold resp. officials of the

Dept. of Labor in contempt since the instant

dispute arose as the result of another

Federal Agency’s attempt to exceed its

Statutory authority. (cvs 83-3554, etc) fld

» * > » ~

Petition for rehg. before the Cour} In Banc by

respondent, John A. Pendergrass w/serv.

filed (evs. 83-3554, etc.) filed (sa)

DATE

Sept. 2

Nov. 28

Dec. 5

Dec. §

1989

Jan. 17

FILINGS— PROCEEDINGS

Petition for rehg. before the Court In Banc by

Intervenor, United Technologies w/serv.

filed (cvs. 83-3554, etc.) filed (sa)

* * * * *

Order (Gibbons Chief Judge Stapleton Mans-

mann Greenberg Hutchinson Scirica and

Cowen Circuit Judges Fisher and Kelly

District Judges*) denying the petition for

rehg. by respondent before the Court In

Banc (cvs. 83-3554, etc.) filed “As to panel

rehg. only (sa)

Order (Gibbons, Chief Judge Stapleton Mans-

mann Greenberg Hutchinson Scirica and

Cowen Circuit Judges Fisher & Kelly

District Judge*) denying the petition for

rehg. by intervenor, United Technologies

before the Ct. In Banc. (cvs. 83-3554, etc.

filed “As to panel rehg. only (sa)

Mot. by respondent Pendergrass to stay man-

date to 1/5/89, w/serv. fld (cvs. 83-3554,

etc.) as

Mot. by Associated General Contractors coun-

sel for petitioners to stay mandate w/serv.

filed to 1-5-89 (cvs. 83.3554, etc. &

88-3345/8) sa

* * * * *

Copy of Supreme Court Order dated 1/13/89

by Justice Brennan ordering that the man-

dates of the U.S. Court of Appeals for the

3rd Cir. Nos. 83-3554, et al. and 88-3345,

88-3347 and 88-3348 set to issue 1-13-89 are

DATE

Jan. 17

Jan. 30

FILINGS — PROCEEDINGS

hereby stayed pending receipt of responses

to the applicaiton due on Monday 1-23-89

and further order of the undersigned or of

the Ct. Filed (cvs. 83-3554, et al. 88-3345/8)

Order (Gibbons, Chief Judge Scirica and

Aldisert Cir. Judges) the mot. to stay the

mandate is denied. The remaining pending

mots. are moot. (cvs. 83-3554, et a

88-3345/8) filed (sa)

Certified Copy of S.C. Order by Justice Bren-

nan entered 1/13/89 staying U.S. Court of

Appeals mandates is vacated & application

in all respects is denied. Fld.S.C. Nos.

88-1070 & 88-1075 (cvs. 83-3554, et al.

88-3345, 88-3347/8) sa

Certified judgment issued in lieu of a formal

mandate (cvs. 83-3554, et al) sa

The Department of Labor's Hazard Communication Standard

(29 C.F.R. 1910.1200)

§ 1910.1200 Hazard communication.

(a) Purpose. (1) The purpose of this section is to en-

sure that the hazards of all chemicals produced or im-

ported are evaluated, and that information concerning

their hazards is transmitted to employers and employees.

This transmittal of information is to be accomplished by

means of comprehensive hazard communication pro-

gramis, which are to include container labeling and other

forms of warning, material safety data sheets and em-

ployee training.

(2) This occupational safety and health standard is in-

tended to address comprehensively the issue of evaluating

the potential hazards of chemicals, and communicating in-

formation concerning hazards and appropriate protective

measures to employees, and to preempt any legal require-

ments of a state, or political subdivision of a state, per-

taining to the subject. Evaluating the potentiai hazards of

chemicals, and communicating information concerning

hazards and appropriate protective measures to em-

ployees, may include, for example, but is not limited to,

provisions for: developing and maintaining a written

hazard communication program for the workplace, in-

cluding lists of hazardous chemicals present; labeling of

containers of chemicals being shipped to other work-

places; preparation and distribution of material safety

data sheets to employees and downstream employers; and

development and implementation of employee training

programs regarding hazards of chemicals and protective

measures. Under section 18 of the Act, no state or political

subdivision of a state may adopt or enforce, through any

court or agency, any requirement relating to the issue ad-

dressed by this Federal standard, except pursuant to a

Federally-approved state plan.

(b) Scope and application. (1) This section requires

chemical manufacturers or importers to assess the hazards

of chemicals which they produce or import, and all em-

ployers to provide information to their employees about

the hazardous chemicals to which they are exposed, by

means of a hazard communication program, labels and

other forms of warning, material safety data sheets, and

information and training. In addition, this section requires

distributors to transmit the required information to em-

ployers.

(2) This section applies to any chemical which is

known to be present in the workplace in such a manner

that employees may be exposed under normal conditions

of use or in a foreseeable emergency.

(3) This section applies to laboratories only as follows:

(i) Employers shall ensure that labels on incoming

containers of hazardous chemicals are not removed or de-

faced;

(ii) Employers shall maintain any material safety data

Sheets that are received with incoming shipments of haz-

ardous chemicals, and ensure that they are readily acces-

sible to laboratory eniployees; and,

(iii) Employers shall ensure that laboratory employees

are apprised of the hazards of the chemicals in their work-

places in accordance with paragraph (h) of this section.

(4) In work operations where employees only handle

chemicals in sealed containers which are not opened under

normal conditions of use (such as are found in marine

cargo handling, warehousing, or retail sales), this section

applies to these operations only as follows:

(1) Employers shall ensure that labels on incoming

containers of hazardous chemicals are not removed or de-

faced;

(ii) Employers shall maintain copies of any material

safety data sheets that are received with incoming ship-

ments of the sealed containers of hazardous cher .c2's,

shall obtain a material safety data sheet for sealed con-

tainers of hazardous chemicals received without a material

safety data sheet if an employee requests the material safe-

ty data sheet, and shall ensure that the material safety data

sheets are readily accessible during each work shift to em-

ployees when they are in their work area(s); and,

(iii) Employers shall ensure that employees are provid-

ed with information and training in accordance with para-

graph (h) of this section (except for the location and avail-

ability of the written hazard communication program

under paragraph (h)(1)(iii)), to the extent necessary to pro-

tect them in the event of a spill or leak of a hazardous

chemical from a sealed container.

(5) This section does not require labeling of the fol-

lowing chemicals:

(i) Any pesticide as such term is defined in the Federal

Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136

et seq.), when subject to the labeling requirements of that

Act and labeling regulations issued under that Act by the

Environmental Protection Agency;

(ii) Any food, food additive, color additive, drug, cos-

metic, or medical or veterinary device, including materials

intended for use as ingredients in such products (e.g.

flavors and fragrances), as such terms are defined in the

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

seq.) and regulations issued under that Act, when they are

subject to the labeling requirements under that Act by the

Food and Drug Administration;

(iii) Any distilled spirits (beverage alcohols), wine, or

malt beverage intended for nonindustrial use, as such

terms are defined in the Federal Alcohol Administration

Act (27 U.S.C. 201 et seq.) and regulations issued under

that Act, when subject to the labeling requirements of that

Act and labeling regulations issued under that Act by the

Bureau of Alcohol Tobacco, and Firearins; and,

(iv) Any consumer product or hazardous substance as

those terms are defined in the Consumer Product Safety

Act (15 U.S.C. 2051 et seq.) and Federal Hazardous Sub-

stances Act (15 U.S.C. 1261 et seq.) respectively, when

subject to a consumer product safety standard or labeling

requirement of those Acts, or regulations issued under

those Acts by the Consumer Product Safety Commission.

(6) This section does not apply to:

(i) Any hazardous waste as such term is defined by the

Solid Waste Disposal Act, as amended by the Resource

Conservation and Recovery Act of 1976, as amended (42

U.S.C. 6901 et seq.), when subject to regulations issued

under that Act by the Environmental Protection Agency;

(ii) Tobacco or tobacco products;

(iii) Wood or wood products;

(iv) Articles;

(v) Food, drugs, cosmetics, or alcoholic beverages in a

retail establishment which are packaged for sale to con-

sumers;

(vi) Foods, drugs, or cosmetics intended for personal

consumption by employees while in the workplace;

(vii) Any consumer product or hazardous substance,

as those terms are defined in the Consumer Product Safety

Act (15 U.S.C. 2051 et seg.) and Federal Hazardous Sub-

stances Act (15 U.S.C. 1261 ef seq.) respectively, where

the employer can demonstrate it is used in the workplace

in the same manner as normal consumer use, and which

use results in a duration and frequency of exposure which

is NOt greater than exposures experienced by consumers;

and,

(viii) Any drug, as that term is defined in the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 301 ef seq.),

when it is in solid, final form for direct administration to

the patient (i.e. tablets or pills).

“Article” means a manufactured item: (i) Which is

formed to a specific shape or design during manufacture;

(ii) which has end use function(s) dependent in whole or in

part upon its shape or design during end use; and (iii)

which does not release, or otherwise result in exposure to,

a hazardous chemical, under normal conditions of use.

“Assistant Secretary” means the Assistant Secretary of

Labor for Occupational Safety and Health, U.S. Depart-

ment of Labor, or designee.

“Chemical” means any element, chemical compound or

mixture of elements and/or compounds.

“Chemical manufacturer” means an employer with a

workplace where chemical(s) are produced for use or dis-

tribution.

“Chemical name” means the scientific designation of a

chemical in accordance with the nomenclature system de-

veloped by the International Union of Pure and Applied-

Chemistry (IUPAC) or the Chemical Abstracts Service

(CAS) rules of nomenclature, or a name which will clearly

identify the chemical for the purpose of conducting a

hazard evaluation.

“Combustible liquid” means any liquid having a flash-

point at or above 100°F (37.8°C), but below 200°F

(93.3°C), except any mixture having components with

flashpoints of 200°F (93.3°C), or higher, the total volume

of which make up 99 percent or more of the total volume

of the mixture.

“Common name” means any designation or identifica-

tion such as code name, code number, trade name, brand

name or generic name used to identify a chemical other

than by its chemical name.

“Compressed gas” means:

(i) A gas or mixture of gases having, in a container, an

absolute pressure exceeding 40 psi at 70°F (21.1°C); or

(ii) a gas or mixture of gases having, in a container, an

absolute pressure exceeding 104 psi at 130°F (54.4°C) re-

gardless of the pressure at 70°F) 21.1°C); or

(iii) A liquid having a vapor pressure exceeding 40 psi

at 100°F (37.8°C) as determined by ASTM D-323-72.

“Container” means any bag, barrel, bottle, box, can,

cylinder, drum, reaction vessel, storage tank, or the like

that contains a hazardous chemical. For purposes of this

section, pipes or piping systems, and engines, fuel tanks,

or other operating systems in a vehicle, are not considered

to be containers.

“Designated representative” means any individual or or-

ganization to whom an employee gives written authoriza-

tion to exercise such employee’s rights under this section.

A recognized or certified collective bargaining agent shall

be treated automatically as a designated representative

without regard to written employee authorization.

“Director” means the Director, National Institute for

Occupational Safety and Health, U.S. Department of

Health and Human Services, or designee.

“Distributor” means a business, other than a chemical

manufacturer or importer, which supplies hazardous

chemicals to other distributors or to employers,

“Employee” means a worker who may be exposed to

hazardous chemicals under normal operating conditions or

in foreseeable emergencies. Workers such as office workers

or bank tellers who encounter hazardous ‘chemicals dnly in

non-routine, isclated instances are not covered.

“Employer” means a person engaged in a business where

chemicals are either used, distributed, or are produced for

use or distribution, including a contractor or subcon-

tractor.

“Explosive” means a chemical that causes a sudden,

almost instantaneous release of pressure, gas, and heat

when subjected to sudden shock, pressure, or high temper-

ature. .

“Exposure” or “exposed” ineans that an employee is

subjected to a hazardous chemical in the course of em-

ployment through any route of entry (inhalation, inges-

tion, skin contact or absorption, etc.), and includes poten-

tial (e.g. accidental or possible) exposure.

“Flammable” means a chemical that falls into one of the

following categories:

(i) “Aerosol, flammable” means an aerosol that, when

tested by the method described in 16 CFR 1500.45, yields a

flame projection exceeding 18 inches at full valve opening,

or a flashback (a flame extending back to the valve) at any

degree of valve opening;

(ii) “Gas, flammable” means:

(A) A gas that, at ambient temperature and pressure,

forms a flammable mixture with air at a concentration of

thirteen (13) percent by volume or less; or

(B) A gas that, at ambient temperature and pressure,

forms a range of flammable mixtures with air wider than

twelve (12) percent by volume, regardless of the lower

limit;

(iii) “Liquid, flammable” means any liquid having a

flashpoint below 100°F (37.8°C), except any mixture hav-

ing components with flashpoints of 100°F (37.8°C) or

higher, the total of which make up 99 percent or more of

the total volume of the mixture;

(iv) “Solid, flammable” means a solid, other than a

blasting agent or explosive as defined in § 190.109(a), that

‘is liable to cause fire through friction, absorption of

moisture, spontaneous chemical change, or retained heat

from manufacturing or processing, or which can be ig-

nited readily and when ignited burns so vigorously and

persistently as to create a serious hazard. A chemical shall

be considered to be a flammable solid if, when tested by

the method described in 16 CFR 1500.44, it ignites and

burns with a self-sustained flame at a rate greater than

one-tenth of an inch per second along its major axis.

“Flashpoint” means the minimum temperature at which

a liquid gives off a vapor in sufficient concentration to ig-

nite when tested as follows:

(i) Tagliabue Closed Tester (See American National

Standard Method of Test for Flash Point by Tag Closed

Tester, Z11.24-1979 (ASTM D 56-79)) for liquids with a

viscosity of less than 45 Saybolt University Seconds (SUS)

at 100°F (37.8°C), that do not contain suspended solids

and do not have a tendency to form a surface film under

test; or

(ii) Pensky-Martens Closed Tester (See American Na-

tional Standard Method of Test for Flash Point by

Pensky-Martens Closed Tester, Z11.7-1979 (ASTM D

93-79)) for liquids with a viscosity equal to or greater than

45 SUS at 100°F (37.8°C), or that contain suspended

solids, or that have a tendency to form a surface film

under test; or

(ili) Setaflash Closed Tester (see American National

Standard Method of Test for Flash Point by Setaflash

Closed Tester (ASTMD 3278-78))

Organic peroxides, which undergo autoaccelerating

thermal decomposition, are excluded from any of the

flashpoint determination methods specified above.

“Foreseeable emergency” means any potential occur-

rence such as, but not limited to, equipment failure, rup-

ture of containers, or failure of control equipment which

could result in an uncontrolled release of a hazardous

chemical into the workplace.

“Hazardous chemical” means any chemical which is a

physical hazard or a health hazard.

“Hazard warning” means any words, pictures, symbols,

or combination thereof appearing on a label or other ap-

propriate form of warning which convey the hazard(s) of

the chemical(s) in the container(s).

“Health hazard” means a chemical for which there is

statistically significant evidence based on at least one study

conducted in accordance with established scientific prin-

ciples that acute or chronic health effects may occur in ex-

posed employees. The term “health hazard” includes

chemicals which are carcinogens, toxic or highly toxic

agents, reproductive toxins, irritants, corrosives, sensi-

tizers, hepatotoxins, nephrotoxins, neurotoxins, agents

which act on the hematopoietic system, and agents which

damage the lungs, skin, eyes, or mucous membranes. Ap-

pendix A provides further definitions and explanations of

the scope of health hazards covered by this section, and

Appendix B describes the criteria to be used to determine

whether or not a chemical is to be considered hazardous

for purposes of this standard.

“Identity” means any chemical or common name which

is indicated on the material safety data sheet (MSDS) for

the chemical. The identity used shall permit cross-refer-

ences to be made among the required list of hazardous

chemicals, the label and the MSDS.

“Immediate use” means that the hazardous chemical will

be under the control of and used only by the person who

transfers it from a labeled container ond only within the

work shift in which it is transferred.

“Importer” means the first business with employees

within the Customs Territory of the United States which

receives hazardous chemicals produced in other countries

for the purpose of supplying them to distributors or em-

ployers within the United States.

“Label” means any written, printed, or graphic

material, displayed on or affixed to containers of hazard-

ous chemicals.

“Material safety data sheet (MSDS)” means written or

printed material concerning a hazardous chemical which is

prepared in accordance with paragraph (g) of this section.

“Mixture” means any combination of two or more

chemicals if the combination is not, in whole or in part,

the result of a chemical reaction.

“Organic peroxide” means an organic compound that

contains the bivalent -O-O-structure and which may be

considered to be a structural derivative of hydrogen per-

oxide where one or both of the hydrogen atoms has been

replaced by an organic radical.

“Oxidizer” means a chemical other than a blasting agent

or explosive as defined in § 1910.109(a), that initiates or

promotes combustion in other materials, thereby causing

fire either of itself or through the release of oxygen or

other gases.

“Physical hazard” means a chemical for which there is

scientifically valid evidence that it is a combustible liquid,

a compressed gas, explosive, flammable, an organic per-

oxide, an oxidizer, pyrophoric, unstable (reactive) or

water-reactive. -

“Produce” means to manufacture, process, formulate,

or repackage.

“Pyrophoric” means a chemical that will ignite spon-

taneously in air at a temperature of 130°F (54.4°C) or

below.

“Responsible party” means someone who can provide

additional information on the hazardous chemical and ap-

propriate emergency procedures, if necessary.

“Specific chemical identity” means the chemical name,

Chemical Abstracts Service (CAS) Registry Number, or

any other information that reveals the precise chemical

designaton of the substance.

“Trade secret” means any confidential formula, pattern,

process, device, information or compilation of informa-

tion that is used in an employer’s business, and that gives

the employer an opportunity to obtain an advantage over

competitors who do not know or use it. Appendix D sets

out the criteria to be used in evaluating trade secrets.

“Unstable (reactive)” means a chemical which in the

pure state, or as produced or transported, will vigorously

polymerize, decompose, condense, or will becoine self-

reactive under conditions of shocks, pressure or tempera-

ture.

“Use” means to package, handle, react, or transfer.

“Water-reactive” means a chemical that reacts with

water to release a gas that is either flammable or presents a

health hazard.

“Work area” means a room or defined space in a-work-

place where hazardous chemicals are produced or used,

and where employees are present.

“Workplace” means an establishment, job site, or pro)j-

ect, at one geographical location containing one or more

work areas.

(d) Hazard determination. (1) Chemical manufac-

turers and importers shall evaluate chemicals produced in

their workplaces or imported by them to determine if they

are hazardous. Employers are not required to evaluate

chemicals unless they choose not to rely on the evaluation

performed by the chemical manufacturer or importer for

the chemical to satisfy this requirement.

(2) Chemical manufacturers, importers or employers

evaluating chemicals shall identify and consider the avail-

able scientific evidence concerning such hazards. For

health hazards, evidence which is statistically significant

and which is based on at least one positive study con-

ducted in accordance with established scientific principles

is considered to be sufficient to establish a hazardous ef-

fect if the results of the study meet the definitions of

health hazards in this section. Appendix A shall be con-

sulted for the scope of health hazards covered, and Ap-

pendix B shall be consulted for the criteria to be followed

with respect to the completeness of the evaluation, and the

data to be reported.

(3) The chemical manufacturer, importer or employer

evaluating chemicals shall treat the following sources as

establishing that the chemicals listed in them are hazard-

ous: -

(i) 29 CFR Part 1910, Subpart Z, Toxic and Hazard-

ous Substances, Occupational Safety and Health Admin-

istration (OSHA); or,

(ii) Threshold Limit Values for Chemical Substances

and Physical Agents in the Work Environment, American

Conference of Governmental Industrial Hygienists

(ACGIH) (latest edition).

The chemical manufacturer, importer, or employer is

still responsible for evaluating the hazards associated with

the chemicals in these source lists in accordance with the

requirements of this standard.

(4) Chemical manufacturers, importers and employers

evaluating chemicals shall treat the following sources as

establishing that a chemical is a carcinogen or potential

carcinogen for hazard communication purposes:

(i) National Toxicology Program (NTP), Annual

Report on Carcinogens (latest edition);

(ii) International Agency for Research on Cancer

(IARC ) Monographs (latest editions); or

(iii) 29 CFR Part 1910, Subpart Z, Toxic and Hazard-

ous Substances, Occupational Safety and Health Admin-

istration.

Note: The Registry of Toxic Effects of Chemical Sub-

stances published by the National Institute for Occu-

pational Safety and Health indicates whether a chemical

has been found by NTP or IARC to be a potential carcino-

gen.

(5) The chemical manufacturer, importer or employer

shall determine the hazards of mixtures of chemicals as

follows:

(i) If a mixture has been tested as a whole to determine

its hazards, the results of such testing shall be used to .

determine whether the mixture is hazardous;

(ii) If amixture has not been tested as a whole to deter-

mine whether the mixture is a health hazard, the mixture

shall be assumed to present the same health hazards as do

the components which comprise one percent (by weight or

volume) or greater of the mixture, except that the mixture

shall be assumed to present a carcinogenic hazard if it con-

tains a component in concentrations of 0.1 percent or

greater which is considered to be a carcinogen under para-

graph (d)(4) of this section;

(iii) If a mixture has not been tested as a whole to

determine whether the mixture is a physical hazard; the

chemical manufacturer, importer, or employer may use

whatever scientifically valid data is available to evaluate

the physical hazard potential of the mixture; and;

(iv) If the chemical manufacturer, importer, or em-

ployer has evidence to indicate that a component present

in the mixture in concentrations of less than one percent

(or in the case of carcinogens, less than 0.1 percent) could

be released in concentrations which would exceed an es-

tablished OSHA permissible exposure limit or ACGIH

Threshold Limit Value, or could present a health hazard

to employees in those concentrations, the mixture shall be

assumed to present the same hazard.

(6) Chemical manufacturers, importers, or employers

evaluating chemicals shall describe in writing the pro-

cedures they use to determine the hazards of the chemical

they evaluate. The written procedures are to be made

available, upon request, to employees, their designated

representatives, the Assistant Secretary and the Director.

The written description may be incorporated into the writ-

ten hazard communication program required under para-

graph (e) of this section.

(e) Written hazard communication program. (1) Em-

ployers shall develop, implement, and maintain at the

work place, a written hazard communication program for

their workplaces which at least describes how the criteria

specified in paragraphs (f), (g), and (h) of this section for

labels and other forms of warning, material Safety data

sheets, and employee information and training will be

met, and which also includes the following:

(i) A list of the hazardous chemicals known to be pres-

ent using an identity that is referenced on the appropriate

material safety data sheet (the list may be compiled for the

workplace as a whole or for individual work areas); and

(ii) The methods the employer will use to inform em-

ployees of the hazards of non-routine tasks (for example

the cleaning of reactor vessels), and the hazards associated

with chemicals contained in unlabeled pipes in their work

areas.

(2) Multi-employer workplaces. Employers who pro-

duce, use, or store hazardous chemicals at a workplace in

such a way that the employees of other employer(s) may be

expused (for example, employees of a construction con-

tractor working on-site) shall additionally ensure that the

hazard communication programs developed and imple-

mented under this paragraph (e) include the following:

(1) The methods the employer will use to provide the

other employer(s) with a copy of the material safety data

sheet, or to make it available at a central location in the

workplace, for each hazardous chemical the other em-

ployer(s)’ employees may be exposed to while working;

(ii) The methods the employer will use to inform the

other employer(s) of any precautionary measures that

need to be taken to protect employees during the work-

place’s normal operating conditions and in foreseeable

emergencies; and,

(iii) The methods the employer will use to inform the

other employer(s) of the labeling system used in the work-

place.

(3) The employer may rely on an existing hazard com-

munication program to comply with these requirements,

provided that it meets the criteria established in this para-

graph (e).

(4) The employer shall make the written hazard com-

munication program available, upon request, to em-

ployees, their designated represen atives, the Assistant

Secretary and the Director, in accordance with the require-

ments of 29 CFR 1910.20(e).

(f) Labels and other forms of warning. (1) The chemi-

cal manufacturer, importer, or distributor shall ensure

that each container of hazardous chemicals leaving the

workplace is labeled, tagged or marked with the following

information:

(i) Identity of the hazardous chemical(s);

(ii) Appropriate hazard warnings; and

(iii) Name and address of the chemical manufacturer,

importer, or other responsible party.

(2) For solid metal (such as a steel beam or a metal

casting) that is not exempted as an article due to its down-

stream use, the required label may be transmitied to the

customer at the time of the initial shipment, and need not

be included with subsequent shipments to the same em-

ployer unless the information on the label changes. The

label may be transmitted with the initial shipment itself, or

with the material safety data sheet that is to be provided

prior to or at the time of the first shipment. This exception

to requiring labels on every container of hazardous

chemicals is only for the solid metal itself and does not ap-

ply to hazardous chemicals used in conjunction with, or

known to be present with, the metal and to which em-

ployees handling the metal may be exposed (for example,

cutting fluids or lubricants).

(3) Chemical manufacturers, importers, or distribu-

tors shall ensure that each container of hazardous chemi-

cals leaving the workplace is labeled, tagged, or marked in

accordance with this section in a manner which does not

conflict with the requirements of the Hazardous Materials

Transportation Act (49 U.S.C. 1801 ef seq.) and regula-

tions issued under that Act by the Department of Trans-

portation.

(4) If the hazardous chemical is regulated by OSHA in

a substance-specific health standard, the chemical manu-

facturer, importer, distributor or employer shall ensure

that the labels or other forms of warning used are in ac-

cordance with the requirements of that standard.

(5) Except as provided in paragraphs (f)(6) and (f)(7)

the employer shall ensure that each container of hazardous

chemicals in the workplace is labeled, tagged or marked

with the following information:

(i) Identity of the hazardous chemical(s) contained

therein; and

(ii) Appropriate hazard warnings.

(6) The employer may use signs, placards, process

sheets, batch tickets, operating procedures, or othey such

written materials in lieu of affixing labels to individual sta-

tionary process containers, as long as the alternative

method identifies the containers to which it is applicable

and conveys the information required by paragraph (f)(5)

of this section to be on a label. The written materials shall

be readily accessible to the employees in their work area

throughout each work shift.

(7) The employer is not required to label portable con-

tainers into which hazardous chemicals are transferred

from labeled containers, and which are intended only for

the immediate use of the employee who performs the

transfer.

(8) The employer shall not remove or deface existing

labels on incoming containers of hazardous chemicals,

unless the container is immediately marked with the re-

quired information.

(9) The employer shall ensure that labels or other

forms of warning are legible, in English, and prominently

displayed on the container, or readily available in the work

area throughout each work shift. Employers having em-

ployees who speak other languages may add the informa-

tion in their language to the material presented, as long as

the information is presented in English as well.

(10) The chemical manufacturer, importer, distributor

or emple yer need not affix new labels to comply with this

section f existing labels already convey the required infor-

mation.

(g) Material safety data sheets. (1) Chemical manu-

facturers and itaporters shall obtain or develop a material

safety data sheet for each hazardous chemical they pro-

duce or import. Employers shall have a material safety

~ @ata sheet for each hazardous chemical which they use.

(2) Each material safety data sheet shall be in English

and shall contain at least the following information:

(i) The identity used on the label, and, except as pro-

vided for in paragraph (i) of this section on trade secrets:

(A) If the hazardous chemical is a single substance, its

chemical and common name(s);

(B) If the hazardous chemical is a mixture which has

been tested as a whole to determine its hazards, the chemi-

cal and common name(s) of the ingredients which con-

tribute to these known hazards, and the common name(s)

of the mixture itself; or,

not been tested as a whole:

(/) The chemical and common name(s) of all ingredi-

ents which have been determined to be health hazards, and

which comprise 1% or greater oi the composition, except

that chemicals identified as carcinogens under paragraph

(d)(4) of this section shall be listed if the concentrations

are 0.1% or greater; and,

(2) The chemical and common name(s) of all ingredi-

ents which have been determined to be health hazards, and

which comprise less than 1% (0.1% for carcinogens) of

the mixture, if there is evidence that the ingredient(s) could

be released from the mixture in concentrations which

would exceed an established OSHA permissible exposure

limit or ACGIH Threshold Limit Value, or could present a

health hazard to employees; and,

(3) The chemical and common name(s) of all ingredi-

ents which have been determined to present a physical

hazard when present in the mixture;

(ii) Physical and chemical characteristics of the haz-

ardous chemical (such as vapor pre ‘sure, flash point);

(ili) The physical hazards of the hazardous chemical,

including the potential for fire, explosion, and reactivity;

(iv) The health hazards of the hazardous chemical, in-

cluding signs and symptoms of exposre, and any medical

conditions which are generally recognized as being aggra-

vated by exposure to the chemical;

(v) The primary route(s) of entry;

(vi) The OSHA permissible exposure limit, ACGIH

Threshold Limit Value, and any other exposure limit used

or recommended by the chemical manufacturer, importer,

or employer preparing the material safety data-sheet,

where available;

(vii) Whether the hazardous chemical is listed in the

National Toxicology Program (NTP) Annual Report on

Carcinogens (latest edition) or has been found to be a

potential carcinogen in the International Agency for Re-

search on Cancer (LARC) Monographs (latest editions), or

by OSHA;

(viii) Any generally applicable precautions for safe

handling and use which are known to the chemical manu-

facturer, importer or employer preparing the material

safety data sheet, including appropriate hygienic practices,

protective measures during. repair and maintenance of

contaminated equipment, and procedures for clean-up of

spills and leaks;

(ix) Any generally applicable control measures which

are known to the chemical manufacturer, importer or em-

ployer preparing the material safety data sheet, such as ap-

propriate engineering controls, work practices, or per-

sonal protective equipment;

(x) Emergency and first aid procedures;

(xi) The date of preparation of the material safety data

sheet or the last change to it; and,

(xii) The name, address and telephone number of the

chemical manufacturer, importer, employer or other re-

sponsible party preparing or distributing the material safe-

ty data sheet, who can provide additional information on

the hazardous chemical and appropriate emergency pro-

cedures, if necessary.

(3) If no relevant information is found for any given

category on the material safety data sheet, the chemical

manufacturer, importer or employer preparing the mate-

rial safety data sheet shall mark it to indicate that no appli-

cable information was found.

(4) Where complex mixtures have similar hazards and

contents (i.e. the chemical ingredients are essentially the

same, but the specific composition varies from mixture to

mixture), the chemical manufacturer, importer or em-

ployer may prepare one material safety data sheet to apply

to all of these similar mixtures.

(5) The chemical manufacturer, importer or employer

preparing the material safety data sheet shall ensure that

the information recorded accurately reflects the scientific

evidence used in making the hazard determination. If the

chemical manufacturer, importer or employer preparing

the material safety data sheet becomes newly aware of any

significant information regarding the hazards of a chemi-

cal, or ways to protect against the hazards, this new infor-

mation shall be added to the material safety data sheet

within three months. If the chemical is not currently being

produced or imported the chemical manufacturer or im-

porter shall add the information to the material safety

data sheet before the chemical is introduced into the work-

place again.

(6) Chemical manufacturers or importers shall ensure

that distributors and employers are provided an appro-

priate material safety data sheet with their initial ship-

ment, and with the first shipment after a material safety

data sheet is updated. The chemical manufacturer or im-

porter shall either provide material safety data sheets with

the shipped containers or send them to the employer prior

io or at the time of the shipment. If the material safety

data sheet is not provided with a shipment that has been

labeled as a hazardous chemical, the employer shall obtain

one from the chemical manufacturer, importer, or dis-

tributor as soon as possible.

(7) Distributors shall ensure that material safety data

sheets, and updated information, are provided to other

distributors and employers. Retail distributors which sell

hazardous chemicals to commercial customers shall pro-

vide a material safety data sheet to such ernmployers upon

request, and shall post a sign or otherwise inform them

that a material safety data sheet is available. Chemical

manufacturers, importers, and distributors need not pro-

vide material safety data sheets to retail distributors which

have informed them that the retail distributor does not sell

the product to commercial customers or open the sealed

container to use it in their own workplaces.

(8) The employer shall maintain copies of the required

material safety data sheets for each hazardous chemical in

the workplace, and shall ensure that they are readily ac-

cessible during each work shift to employees when they are

in the their work area(s).

(9) Where employees must travel between workplaces

during a workshift, i.e., their work is carried out at more

than one geographical location, the material safety data

sheets may be kept at a central location at the primary

workplace facility. In this situation, the employer shall en-

sure that employees can immediately obtain the required

information in an emergency.

(10) Material safety data sheets may be kept in any

form, including operating procedures, and may be de-

signed to cover groups of hazardous chemicals in a work

area where it may be more appropriate to address the

hazards of a process rather than individual hazardous

chemicals. However, the employer shall ensure that in all

cases the required information is provided for each haz-

ardous chemical, and is readily accessible during each

work shift to employees when they are in in their work

area(s).

(11) Material safety data sheets shall also be made

readily available, upon request, to designated representa-

tives and to the Assistant Secretary, in accordance with the

requirements of 29 CFR 1910.20 (e). The Director shall

also be given access to material safety data sheets in the

same manner.

(h) Employee information and training. Employers

shall provide employees with information and training on

hazardous chemicals in their work area at the time of their

initial assignment, and whenever a new hazard is intro-

duced into their work area.

(1) Jnformation. Employees shall be informed of:

(i) The requirements of this section;

(ii) Any operations in their work area where hazard-

ous chemicals are present; and,

(iii) The location and availability of the written hazard

communication program, including the required list(s) of

hazardous chemicals, and material safety data sheets re-

quired by this section.

(2) Training. Employee training shall include at least:

(i) Methods and observations that may be used to

detect the presence or release of a hazardous chemical in

the work area (such as monitoring conducted by the em-

ployer, continuous monitoring devices, visual appearance

or odor of hazardous chemicals when being released, etc.);

(ii) The physical and health hazards of the chemicals

in the work area;

(iii) The measures employees can take to protect them-

selves from these hazards, including specific procedures

the employer has implemented to protect employees from

exposure to hazardous chemicals, such as appropriate

work practices, emergency procedures, and personal pro-

tective equipment to be used; and,

(iv) The details of the hazard communication program

developed by the employer, including an explanation of

the labeling system and the material safety data sheet, and

how employees can obtain and use the appropriate hazard

information.

(i) Trade secrets. (1) The chemical manufacturer, im-

porter, or employer may withhold the specific chemical

identity, including the chemical name and other specific

identification of a hazardous chemical, from the material

safety data sheet, provided that:

(i) The claim that the information withheld is a trade

secret can be supported;

(ii) Information contained in the material safety data

sheet concerning the properties and effects of the hazard-

ous chemical is disclosed;

(iii) The material safety data sheet indicates that the

specific chemical identity is being withheld as a trade

secret; and,

(iv) The specific chemical identity is made available to

health professionals, employees, and designated repre-

sentatives in accordance with the applicable provisions of

this paragraph.

(2) Where a treating physician or nurse determines

that a medical emergency exists and the specific chemical

identity of a hazardous chemical is necessary for emergen-

cy or first-aid treatment, the chemical manufacturer, im-

porter, or employer shall immediately disclose the specific

chemical identity of a trade secret chemical to that treating

physician or nurse, regardless of the existence of a written

statement of need of a confidentiality agreement. The

chemical manufacturer, importer, or employer may re-

quire a written statement of need and confidentiality

agreement, in accordance with the provisions of para-

graphs (i)(3) and (4) of this section, as soon as circum-

stances permit.

(3) In non-emergency situations, a chemical manu-

facturer, importer, or employer shall, upon request, dis-

close a specific chemical identity, otherwise permitted to

be withheld under paragraph (i)(1) of this section, to a

health professional (i.e. physician, industrial hygienist,

toxicologist, epidemiologist, or occupational health nurse)

providing medical or other occupational health services tu

exposed employee(s), and to employees or designated rep-

resentatives, if:

(i) The request is in writing;

(ii) The request describes with reasonable detail one or

more of the following occupational health needs for the

information:

(A) To assess the hazards of the chemicals to which

employees will be exposed;

(B) To conduct or assess sampling of the workplace at-

mosphere to determine employee exposure levels;

surveillance of exposed employees;

(D) To provide medical treatmeni to exposed em-

ployees;

(E) To select or assess appropriate personal protective

equipment for exposed employees;

(F) To design or assess engineering controls or other

protective measures for exposed employees; and,

(G) To conduct studies to determine the health effects

of exposure.

e+ . . . be

(iti) The request explains in detail why the disclosure

of the specific chemical identity is essential and that, in

lieu thereof, the disclosure of the following information to

the health professional, employee, or designated repre-

sentative, would not satisfy the purposes described in

paragraph (i)(3)(ii) of this section:

(A) The properties and effects of the chemical:

(B) Measures for controlling workers’ exposure to the

chemical;

posure to the chemical; and,

(D) Methods of diagnosing and treating harmful ex-

posures to the chemical;

(iv) The request includes a description of the pro-

cedures to be used to maintain the confidentiality of the

disclosed information; and,

(v) The health professional, and the employer or con-

tractor of the services of the health professional (i.c.

downstream employer, labor organization, or individual

employee), employee, or designated representative, agree

in a written confidentiality agreement tiat the health pro-

fessional, employee, or designated representative, will not

use the trade secret information for any purpose other

than the health need(s) asserted and agree not to release

the information under any circumstances other than to

OSHA, as provided in paragraph (i)(6) of this section, ex-

cept as authorized by the terms of the agreement or by the

chemical manufacturer, importer, or employer.

(4) The confidentiality agreement authorized by para-

graph (i)(3)(iv) of this section:

(i) May restrict the use of the information to the health

purposes indicated in the written statement of need;

(ii) May provide for appropriate legal remedies in the

event of 2 breach of the agreement, including stipulation

of a reasonable pre-estimate of likely damages; and,

(iii) May not include requirements for the posting of a

penalty bond.

(5) Nothing in this standard is meant to preclude the

parties from pursuing non-contractual remedies to the ex-

tent permitted by law.

(6) If the health professional, employee, or designated

representative receiving the trade secret information

decides that there is a need to disclose it to OSHA, the

chemical manufacturer, importer, or employer who pro-

vided the information shall be informed by the health pro-

fessional, employee, or designated representative prior to,

or at the same time as, such disclosure.

(7) If the chemical manufacturer, importer, or em-

ployer denies a written request for disclosure of a specific

chemical identity, the denial must:

(i) By provided to the health professional, employee,

or designated representative, within thirty days of the re-

quest;

(ii) Be in writing;

(iii) Include evidence to support the claim that the spe-

cific chemical identity is a trade secret;

(iv) State the specific reasons why the request is being

denied; and,

(v) Explain in detail how alternative information may

satisfy the specific medical or occupational health need

without revealing the specific chemical identity.

(8) The health professional, employee, or designated

representative whose requesi for information is denied

under paragraph (i)(3) of this section may refer the request

and the written denial of the request to OSHA for con-

sideration.

(9) When a health professional, employee, or de ig-

nated representative refers the denial to OSHA under

paragraph (i)(8) of this section, OSHA shall consider the

evidence to determine if:

(i) The chemical manufacturer, importer, or employer

has supported the claim that the specific chemical identity

is a trade secret;

(ii) The health professional, employee, or designated

representative has supported the claim that there is a

medical or occupational health need for the information;

and,

(ili) The health professional, employee, or designated

representative has demonstrated adequate means to pro-

tect the confidentiality.

(10)) If OSHA determines that the specific chemical

identity requested under paragraph (i)(3) of this section is

not a bona fide trade secret, or that it is a trade secret, but

the requesting health professional, employee, or desig-

nated representative has a legitimate medical or occupa-

tional health need for the information, has executed a

written confidentiality agreement, and has shown ade-

quate means to protect the confidentiality of the informa-

tion, the chemical manufacturer, importer, or employer

will be subject to citation by OSHA.

(ii) If achemical manufacturer, importer, or employer

demonstrates to OSHA that the execution of a confiden-

tiality agreement would not provide sufficient protection

against the potential harm from the unauthorized dis-

clocure of a trade secret specific chemical identity, the

Assistant Secretary may issue such orders or impose such

additional limitations or conditions upon the disclosure of

the requested chemical information as may be appropriate

to assure that the occupational health services are provid-

ed without an undue risk of harm to the chemical manu-

facturer, importer, or employer.

(11) Ifa-citation for a failure to release specific chemi-

cal identity information is contested by the chemical

manufacturer, importer, or employer, the matter will be

adjudicated before the Occupational Safety and Health

Review Commission in accordance with the Act’s enforce-

ment scheme and the applicable Commission rules of pro-

cedure. In accordance with the Commission rules, when a

chemical manufacturer, importer, or employer continues

to withhold the information during the contest, the Ad-

ministrative Law Judge may review the citation and sup-

porting documentation in canmiera or issue appropriate

orders to protect the confidentiality or such matters.

(12) Notwithstanding the existence of a trade secret

claim, a chemical manufacturer, importer, or employer

shall, upon request, disclose to the Assistant Secretary any

information which this section requires the chemical

manufacturer, importer, or employer to make available.

Where there is a trade secret claim, such claim shall be

made no later than at the time the information is provided

to the Assistant Secretary so that suitable determinations

of trade secret status can be made and the necessary pro-

tections can be implemented.

(13) Nothing in this paragraph shall be construed as

requiring the disclosure under any circumstances of proc-

ess Or percentage of mixture information which is a trade

secret.

(j) Effective dates. (1) Chemical manufacturers, im-

porters, and distributors shall ensure that material safety

data sheets are provided with the next shipment of hazard-

ous chemicals to employers after September 23, 1987.

(2) Employers in the non-manufacturing sector shall

be in compliance with all provisions of this section by May

23, 1988. (Note: Employers in the manufacturing sector

(SIC Codes 20 through 39) are already required to be in

compliance with this section.)

Excerpts From “Hazard Communication: Notice of Proposed

Rulemaking” (47 Fed. Reg. 12,092 (Mar. 19, 1982))

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. H-022]

Hazard Communication; Notice of Proposed

Rulemaking and Public Hearings

AGENCY: Occupational Safety and Health

Administration, Labor.

ACTION: Notice of proposed rulemaking

and public hearings.

SUMMARY: The proposed standard. requires chemical

manufacturers to assess the hazards of chemicals which

they produce, and all employers having facilities in the

manufacturing division, SIC Codes 20-39, to provide in-

formation to their employees about these hazards by

means of hazard communication programs including

labels, placards, material safety data sheets, information

and training, and access to written records. OSHA has

determined that this standard is necessary because many

employers and employees are not aware of the presence of

hazardous chemicals in their workplaces. The proposed

standard provides for hazard determinations to be con-

ducted to identify these hazards, and for subsequent com-

munication to employees of the hazards thus identified.

These activities should serve to alleviate the lack of

awareness concerning hazardous chemicals, and should

provide an impetus for employees and employers to devise

better means of protection from these hazards. Public

hearings are being scheduled to provide interested parties

the Opportunity to orally present information and data

related to the issues raised by this proposed rule.

* * * * *

{Tjhe current proposal substantially reduces the

documentation necessary on hazard evaluation procedures

as well as other recordkeeping requirements. As a result,

the initial recordkeeping cost is lowered from $31.35

million projected for the January proposal to $14.7

million under the current proposal. The annual cost of

recordkeeping likewise falls from $4.69 million to $2.07

million. This provision —together with more limited label-

ing and the elimination of “no hazard” certifications, in-

formation sheets, and labeling requirements on pipes and

support systems—significantly reduces the paperwork

burden imposed by the January proposal and meets the in-

tent of the Paperwork Reduction Act of 1980.

* * * * ~

Excerpts From “Hazard Communication: Final Rule”

(48 Fed. Reg. 53,280 (Nov. 25, 1983))

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

Hazard Communication

AGENCY: Occupational Safety and Health

Administration (OSHA), Labor.

ACTION: Final rule.

SUMMARY: OSHA is hereby promulgating a final occupa-

tional safety and health standard entitled “Hazard Com-

munication” (29 CFR 1910.1200). The standard requires

chemical manufacturers and importers to assess the

hazards of chemicals which they produce or import, and

all employers having workplaces in the manufacturing

division, Standard Industrial Classification (SIC] codes 20

through 39, to provide information to their employees

concerning hazardous chemicals by means of hazard com-

munication. programs including labels, material safety

data sheets, training, and access to written records. In ad-

dition, distributors of hazardous chemicals are required to

ensure that containers they distribute are properly labeled,

and that a material safety data sheet is provided to their

customers in the manufacturing division SIC Codes.

Implementation of this final standard will reduce the in-

cidence of chemically-related occupational ‘Illnesses and

injuries in employees of the manufacturing division. In-

creased availability of hazard information will assist

employers in these industries to devise appropriate protec-

tive measures, and will give employees the information

they need to take steps to protect themselves.

The twenty-four states with their own OSHA-approved

occupational safety and health plans must adopt a com-

parable standard within six months of this publication

date. These states are: Alaska, Arizona, California, Con-

necticut (for state and local government employees only),

Hawaii, Indiana, lowa, Kentucky, Maryland, Michigan,

Minnesota, Nevada, New Mexico, North Carolina,

Oregon, Puerto Rico, South Carolina, Tennessee, Utah,

Vermont, Virginia, Virgin Islands, Washington, and

Wyoming. Until such time as a state standard is pro-

mulgated, Federal OSHA will provide interim enforce-

ment assistance, as appropriate, in these states.

- * » bd

SUPPLEMENTARY INFORMATION: The recordkeeping re-

quirements in the standard have been approved by the Of-

fice of Management and Budget under the Paperwork

Reduction Act of 1980, Pub. L. 96-511, 44 U.S.C. 3501, e7

seq. The OMB approval number is 1218-0072.

* bd - ™ »

Excerpts From “Hazard Communicafion: Final Rule”

(S2 Fed. Reg. 31,853 (Aug. 24, 1987))

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910, 1915, 1917, 1918, 1926, and 1928

[Docket No. H-0220]

Hazard Communication

AGENCY: Occupational Safety and Health

Administration (OSHA); Labor.

ACTION: Final rule.

SUMMARY: OSHA is revising its Hazard Communication

Standard (HCS) (29 CFR 1910.1200), which currently ap-

plies to the manufacturing sector, to cover all employers

with employees exposed to hazardous chemicals in their

workplaces. Expansion of the scope of the HCS requires

non-manufacturing employers to establish hazard com-

munication programs to transmit information on the

hazards of chemicals to their employees by means of labels

on containers, material safety data sheets, and training

programs. This action will reduce the incidence of

chemically-related occupational illnesses and injuries in

non-manufacturing workplaces.

* * - » bd

Labeling exemptions. The HCS includes a number of

labeling exemptions to ensure that OSHA does not pro-

vide duplicative coverage for products which are already

labeleé under the rules of another Federal agency. It

should be reemphasized that these exemptions (in

paragraph (b)(4) of the original rule; paragraph (b)(5) in

this final rule) are only from the container labeling

requirements under paragraph (f)—all other provisions of

the rule are still in effect. A minor correction is being

made, however, to these exemptions to indicate that when

medical or veterinary devices are labeled in accordance

with the labeling requirements of the Food and Drug Ad-

ministration (FDA) under authority of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 301 ef seg.), those

items are exempted from HCS labeling requirements. All

other items regulated by FDA under that Act were listed in

the HCS labeling exemption. Medical and veterinary

devices were inadvertently omitted from the list of items

that might be subject to FDA labeling requirements under

the Federal Food, Drug, and Cosmetic Act, and they are

exempted from HCS labels for the same reasons that the

other items are exempt when subject to labeling under

FDA. See 48 FR 53289. To ensure that all these FDA

regulated items are treated in the same manner and that

devices are exempted from HCS labeling if subject to FDA

labeling, paragraph (b)(5)(ii) is amended by adding

medical and veterinary devices.

Other exemptions. The HCS includes a number of

specific, total exemptions from the requirements of the

rule for certain types of chemicals. This rule adds three

categories of exemptions: food, drugs, cosmetics, .or

alcoholic beverages in a retail establishment packaged for

retail sale (paragraph (b)(6)(vi); consumer products

(paragraph (b)(6)(vil)); and certain pharmaceuticals

(paragraph (b)(6)(viii)). ‘

Food, drugs, cosmetics, alcoholic beverages. The cur-

rent HCS includes an exemption for food, drugs, or

cosmetics brought into the workplace for employee con-

sumption. These types of exposures are not related to an

employee’s work, and therefore do not need to be covered

under the HCS.

The expansion of the HCS into the non-manufacturing

sector will result in many of these types of products being

present in workplaces (e.g., liquor stores) where they are

not intended for employee consumption, and where they

normally would not result in employee exposure because

they are packaged for sale to consumers. Although some

of these products may meet the definition of a “hazardous

chemical” (e.g., vinegar is acetic acid), when packaged for

retail sale they do not pose a hazard to workers that is any

different than the hazards of such products in their homes.

The label information required by other Federal agencies

for foods, drugs, cosmetics, and alcoholic beverages

should thus provide sufficient protection for workers, and

OSHA has exempted these products from coverage under

the :ule. It should be 1oted that this is not an exemption

for facilities of any particular industry, as all facilities may

have other chemicals in use that would be covered by the

HCS. In addition, since these products are exempted, em-

ployers which package them for retail sale would not have

to furnish materal safety data sheets to distributors receiv-

ing the products.

Consumer products. The current rule provides a labeling

exemption for consumer products when they are labeled in

accordance with the requirements of the Consumer Prod-

uct Safety Commission (CPSC). CPSC requires consumer

products which contain hazardous substance to be ap-

propriately labeled. Examples of consumer products

would include such items as oven cleaner, paint stripper,

and adhesive, which may be found in various types of

workplaces. In addition to the specific labeling exemption,

OSHA has been interpreting the rule as not being ap-

plicable to consumer products when used as a consumer

would use them. OSHA is now adding this interpretation

to the rule itself, paragraph (b)(6)(vi), stating that where

such consumer products are used in the workplace in a a

manner comparable to normal conditions of consumer

use, resulting in a duration and frequency of exposure to

employees which is no greater than exposures experienced

by ordinary consumers, under such conditions the

chemical would not have to be included in the employer’s

hazard communication program. This position is tonsis-

tent with OSHA’s reason for orginally limiting the exemp-

tion for hazardous consumer products used in the course

of employment to only an exemption from HCS labeling,

and not material safety data sheet and training re-

quirements. “OSHA recognizes ... that there may be

situations where worker exposure is significantly greater

than that of consumers, and that under these cir-

cumstances, substances which are safe for contemplated

consumer use may pose unique hazards in the workplace.”

48 FR 53289. However, to the extent that workers are ex-

posed to the substances in a manner similar to that of the

general public, there is no need for any HCS requirements.

One example of such a differentiation in exposure situa-

tions involves the use of abrasive cleaners in_ the

workplace. Where these are used intermittently to clean a

sink, much as they would be used at home, the cleaners

would not be covered under the standard. But if they are

used to clean out reactor vessels, thus resulting in a much

greater level of exposure, they would be covered. Or if an

employee cleans sinks all day long, thus resulting in more

frequent exposures, the abrasive would also be included in

the hazard communication program. Thus workplaces

which only have chemicals which are consumer products

used in the same way amd w frequently as the general

public would normally use them, would not have to have a

hazard communication program.

It should be noted that OSHA intends to read this ex-

emption narrowly. Where an employer i uncertain

whether the duration and frequency of exposure in these

products is comparable §» consumer use, an employer

should obtain or develop the material safety data sheet

and make ut available to employees.

In response to questions raised in the 1985 ANPR.

OSHA received a few comments on the use of consumer

products in the non-manufacturing sector. A number in-

dicated that overexposure may occur from the use of such

products, or that the frequency and duration of workplace

exposure is typically greater than that experienced by con-

sumers (Exs. 2-59, 2-83, 2-100, 2-120, and 2-164). Others

stated that the exposure was comparable to consumer use

(Exs. 2-46 and 2-63). There were several that felt the label

provided enough information, and no additional require-

ments were needed to protect employees (Exs. 2-75, 2-79,

2-99, 2-107, and 2-16), while others felt the employer

should be required (o request material safety data sheets

because employees are not getting enough information

(Exs. 2-109, 2-128, and 2-169). One suggested that the

label note that a material safety data sheet is available on

request (Ex. 2-100), while another contended that when a

product is used by a professional, it is no longer a con-

sumer product (Ex. 2-199). OSHA believes that the con-

sumer product exemption in this final rule takes all of

these concerns into cOnsideration, and strikes a balance

between the practical consideration of acquiring and

maintaining material safety data sheets on CPSC

regulated products which employees are exposed to at

home as well as at work, and the worker’s need for more

hazard information than a CPSC label when exposures are

greater or more frequent than typical public use of the

chemical would generate.

A number of States adopting right-to-work laws have

also developed consumer product exemptions. (See, e.g.,

Wisconsin “Employees’ Right to Know Law”; Illinois

“Toxic Substances Disclosure to Employees Act.”)

However, most of these rules have taken a broader ap-

proach to the consumer product exemption, generally

eliminating coverage of such products unless exposure is

“significantly greater” than consumer exposure during the

“principal consumer use.” OSHA considered and rejected

such language for the consumer product exemption. It

would be very difficult from an enforcement perspective

to determine when exposure to a consumer product is

“significantly greater” than consumer exposure. The key

elements of concern to OSHA are as stated in the con-

sumer product exemption included in this rwle—that the

consumer product be used in the same manner as a con-

sumer would use it (and therefore as intended by the

manufacturer when preparing the label information), and

that the duration and frequency of exposure be essentially

the same as would be experienced by a consumer (and thus

the label warnings would provide adequate protection.) A

broader exemption than this would not be appropriate to

protect workers from occupational exposures that were

not anticipated by the manufacturer when the labels, and

thus the protective measures, were developed.

. - * » ™

Medicine. The rule, paragraph (b)(6)(vii), also includes

an exemption for drugs when they are solid, and are in

final form for direct administration to the patient (/.e.,

pills or tablets). Employees handling such finished drug

products would not be exposed to the chemicals involved,

and would not need information other than that supplied

on the container label under FDA requirements. (The

State of North Carolina adopted a similar exemption in

their Hazard Communication Standard, 13 NCAC

s7C.101(a)(99)).

~ » » ~ *

fe) Written Hazard Communication Program

Under the current rule, a written hazard communication

program must be developed and implemented for each

workplace. Since the current rule covers fixed manufactur-

ing sites, it did not appear to be necessary to specifically

State that the written program be available at the site. With

expansion to non-manufacturing, however, particularly in

the construction industry where a firm may have multiple

sites, the standard must be tailored to specifically state

that the intent is to maintain the written program at each

site. Employees will then be able to access the information

as required. a

The current written hazard communication program re-

quirements include a provision that requires manufactur-

ing employers to provide hazard information to on-site

contractor employers who have employees who may be ex-

posed to the hazards generated by the manufacturer (cur-

rent paragraph (e)(1)(iii)). The current standard does not

address the reverse situation, i.e., where a contractor

employer brings hazardous materials on-site, and exposes

the manufacturer’s employees to them. Since the expanded

rule will affect more worksites with work arrangements of

this type (e.g., construction), and the need for an exchange

of hazard information is obvious, OSHA has revised the

requirements to tailor it to address the multi-employer

workplace. (This was suggested in comments submitted in

response to the ANPR. See Ex. 2-225, comments from the

National Constructors Association. In addition, this situa-

tion has also been addressed in existing State right-to-

know laws. See, e.g., Alabama Act 85-658; Tennessee

“Hazardous Chemical Right to Know Law.”)

Under these provisions (paragraph (e)(2)), the

employers must exchange material safety data sheets, as

well as information about precautionary measures

necessary to protect employees and an indication of the

type of labeling system in use, where exposures may occur

to another employer’s employees. Each employer will then

have the information necessary to inform and train their

employees. This will help ensure that all employees have

sufficient information to protect themselves in the work-

place, regardless of which employer uses the hazardous

chemical.

Consistent with the performance-orientation of the rule,

the provisions do not specify how this coordination is to

be accomplished. This is best left to the discretion of the

parties involved. In many cases, it would probably be most

efficient for the general contractor to coordinate the func-

tion. For example, the general contractor could keep and

make available material safety data sheets in the office on

the site.

It should be emphasized that the exchange of informa-

tion is limited to those situations where exposures of other

employers’ employees may pccur. Given the nature of

multi-employer work sites in construction, there would be

many situations where subcontractors responsible for

various phases of the building project would not have

employees present during other phases and thus no such

exchange would be required. For example, if the electri-

cians are not working near, or at the same time as, the pav-

ing contractor, then no interchange is required. But if a

painting contractor’s workers are using flammable

solvents in an area where another subcom! actor is welding

pipes, this information exchange is vital to ensure proper

protection of employees.

» - il » -

Iv. Clearance of Information Collection Requirements

On March 31, 1983, the Office of Management and

Budget (OMB) published a mew 5 CFR Part 1320, impie-

menting the information collection prowisions of the

Paperwork Reduction Act of 1986, 44 U.S.C. 3501 et seq.

(48 FR 13666). Part 1320, wh.ch became effective on

April 30, 1983, sets forth procedures for agencies to follow

in obtaining OMB clearance for information collection re-

quirements. The sections of the Hazard Communication

Standard which may create recordkeeping requirements

are paragraphs (d) hazard determination; (e) written

hazard communication program; (f) labels and other ap-

propriate forms of warning; (g) material safety data

sheets; (h) information and training; and (i) trade secrets.

In accordance with the provisions of the Paperwork

Reduction Act and the regulations issued pursuant

thereto, OSHA certifies that it has submitted the informa-

tion collection requirements contained in its rule on

hazard communication to OMB for review under section

3504(h) of that Act.

Excerpts From “Hazard Communication: Notice of Proposed

Rulemaking” (53 Fed. Reg. 29,822 (Aug. 8, 1988))

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910, 1915, 1917, 1918, and 1926

[Docket H-022D]

Hazard Communication

AGENCY: Occupational Safety and Health

Administration (OSHA); Labor.

ACTION: Notice of proposed rulemaking (NPRM) and

notice of public hearing.

SUMMARY: On August 24, 1987, OSHA published a final

rule to modify its Hazard Communication Standard

(HCS) (52 FR 31852). The original rule, which was pro-

mulgated on November 25, 1983, covered employees ex-

posed to hazardous chemicals in the manufacturing sector

of industry. The modified rule expanded coverage to all

employees exposed to hazardous chemicals, thus provid-

ing protection for those in non-manufacturng employ-

ments as well as manufacturing.

The HCS requires employers to establish hazard com-

munication programs to transmit information on the

hazards of chemicals to their employees by means of labels

on containers, material safety data sheets, and training

programs. Implementation of these hazard communica-

tion programs will reduce te incidence of chemically-

related occupational illnesses and injuries.

An advance notice of proposed rulemaking (ANPR) on

expansion of the scope had been published on November

27, 1985 (S50 FR 48794). OSHA was subsequently directed

by the U.S. Court of Appeals for the Third Circuit to issue

a final standard to expand the scope of industries covered

by the rule within sixty days of its decision issued on May

29, 1987, United Steelworkers of America, AFL-CIC-

CLC v. Pendergrass, 819 F.2d 1263 (3d Cir. 1987), unless

the Agency could demonstrate that such an expansion

would not be feasible. The August final rule was OSHA's

response to the Court’s direction. However, the Agency

recognized that had the standard been developed through

a more complete rulemaking process, additional informa-

tion regarding the feasibility or practicality of the provi-

sions may have been included in the record. OSHA there-

fore established a sixty-day comment period on the final

rule to permit interested parties to provide data or

evidence regarding the feasibility or practicality of the pro-

visions of the rule.

This NPRM proposes modifications to the final rule

based upon information submitted to the rulemaking

record, including a determination made by the Office of

Management and Budget (OMB) under the Paperwork Re-

duction Act regarding the information collection require-

ments of the final rule. OSDA is inviting comment for

sixty (60) days following publication of this NPRM, and is

scheduling a public hearing to provide an opportunity for

additional input.

|. History of OSHA's Hazard Communication Standard

The development of OSHA’s Hazard Communication

Standard (HCS) was initiated in 1974. The process has

been lengthy and is discussed in detail in the preambles to

both the original and revised final rules (see 48 FR

$3280-81 and $2 FR 31852-54). This discussion will focus

on the sequence of events which have occurred since the

original final rule was filed at the Federal Register in 1983.

————_—— T-ttt”t~—s

Petitions for judicial review of the rule were filed in the

U.S. Court of Appeals for the Third Circuit (hereinafter

referred to as the “the Court” or “the Third Circuit”) on

November 22, 1983, by the United Steelworkers of

America, AFL-CIO-CLC, and by Public Citizen, Inc.,

representing itself and a number of labor groups. Motions

to intervene in these cases were received from the

Chemical Manufacturers Association, the American

Petroleum Institute, the National Paint and Coatings

Association, and the States of New York, Connecticut,

and New Jersey. In addition, petitions for review of the

standard were filed by the State of Massachusetts in the

First Circuit; the State of New York in the Second Circuit,

the State of Illinois in the Seventh Circuit; the Flavor and

Extract Manufacturers’ Association in the Fourth Circuit;

and the Fragrance Materials Association in the District of

Columbia Circuit. These cases were subsequently trans-

ferred to the Third Circuit and consolidated into one pro-

ceeding. The cases brought by the Flavor and Extract

Manufacturers’ Association and the Fragrance Materials

Association were withdrawn prior to filing briefs.

The Court issued its initial decision on the challenges to

the rule on May 24, 1985 (United Steelworkers of America

\. Auchter, 763 F.2d 728 (3d Cir. 1985)). (See Ex. 4-21.)

fhe standard was upheld in most respects, but three issues

were remanded to the Agency for reconsideration. The

decision was not appealed.

First, the Court concluded that the definition of trade

secrets incorporated by OSHA included chemical identity

information that was readily discoverable through reverse

envineering and, therefore, was “broader than the protec-

tion afforded trade secrets by state law.” The Court

directed the Secretary of Labor to reconsider a trade secret

definition which would not include chemical identity in-

formation that is readily discoverable through reverse en-

gineering. Secondly, the Court held the trade secret access

rule in the standard invalid insofar as it limited access to

health professionals, but found the access rule otherwise

valid. The Secretary was directed to adopt a rule permit-

ting access by employees and their collective bargaining

representatives to trade secret chemical identities. OSHA

complied with the Court orders regarding the two trade

secret issues in a separate rule, publisiied in final form on

September 30, 1986 (S1 FR 34590). The revised trade

secret provisions were incorporated into the test of the

final rule published on August 24, 1987.

The third issue remanded to OSHA involved the scope

of industries covered by the standard. The original HCS

applied to employers and employees in the manufacturing

sector. The Court directed the Secretary of Labor to

reconsider the standard’s application to employees in other

industry sectors, and “to order its application in those sec-

tors unless he can state reasons why such application

would not be feasible.” 763 F.2d at 739, 743.

OSHA subsequently published an advance notice of

proposed rulemaking (ANPR) to collect comments and in-

formation on the expansion of the scope to cover these ad-

ditional sectors (50 FR 48795; November 27, 1985). In par-

ticular, the Agency sought information on the extent

employers in non-manufacturing industries have already

implemented various aspects of a hazard communication

program. In addition, OSHA wanted to obtain data re-

garding the applicability of the provisions as written in the

original rule to these other sectors. A total of 226

responses were received. (See Ex. 2). OSHA also commis-

sioned a study of the economic impact of extending the

HCS to the fifty major non-manufacturing industry

groups within its jurisdiction. (See Exs. 4-1 and 4-2.)

Based on this newly acquired evidence, as well as the

previous rulemaking record, OSHA was in the process of

drafting a proposed rule.

On January 27, 1987, however, the United Steelworkers

of America, AFL-CIO-CLC and Public Citizen, Inc., peti-

tioners in the 1985 challenge, filed a Motion For An Order

Enforcing the Court’s Judgment and Holding Respondent

in Civil Contempt. Petitioners claimed that the Court’s

1985 order had not authorized OSHA to embark on fur-

ther fact gathering and that OSHA should have made a

feasibility determination based upon the 1985 rulemaking

record. Petitioners also argued that even if further fact

gathering had been allowed by the Court’s order, OSHA’s

pace was unduly slow.

In response, OSHA noted that the Court’s 1985 order

did not specify that OSHA should act on the then-existing

record. OSHA believed that seeking further evidence on

feasibility »» nonmanufacturing was appropriate in light

of its statutory obligation to issue rules that are well

grounded in a factual record. OSHA also asserted that,

consistent with Supreme Court precedent, the Agency

should be permitted to exercise its discretion in determin-

ing the appropriate rulemaking p*ocedures for complying

with the Court’s remand order. Lastily, the Agency argued

that its schedule to complete the rulemaking was

reasonable and did not constitute undue delay.

On May 29, 1987, the Court issued a decision holding

that the Court’s 1985 remand order required consideration

of the feasibility of an expanded standard without further

rulemaking. United Steelworkers of America, AFL-CIO-

CLC v. Pendergrass. 819 F.2d 1263 (3d Cir. 1987). (See

Ex. 4-20.) The Court declared that adequate notice had

been provided to non-manufacturers during the original

rulemaking that they might be covered by the HCS, id. at

1265-1266, 1269, that the answers to the remaining ques-

tions OSHA may have had regarding feasibility were “self-

evident” or “readily ascertainable” trom the bdriginal

record, id. at 1268-69, and that further fact finding was

“unnecessary”. id. at 1268. The Court ordered the Agency

to issue, within 60 days of its order, “a hazard communica-

tion standard applicable to all workers covered by the

OSHA Act, including those which have not been covered

in the hazard communication standard as presently writ-

ten, or a statement of reasons why, on the basis of the

present administrative record, a hazard communication

standard is not feasible.” /d. at 1270.

OSHA subsequently re-evaluated the evidence in the

record and determined that a modified final rule covering

all employers subject to the Act (/.e., both manufacturing

and nonmanufacturing) was both necessary and feasible.

The Agency therefore issued the final rule on Hazard

Communication which was published in the Federal

The only modifications OSHA made to the original rule

in the August revision were those that were related to ex-

pansion of the scope. if the Agency had been able to

publish a NPRM at that point, it had planned to propose

other modifications based upon the ANPR comments as

well as OSHA's considerable experience in implementing

the original rule, and the experience of OSHA-approved

State Plan States in implementing the HCS in the non-

manufacturing sector. Publication of a final rule pre-

cluded any actions other than those specifically required

by the expansion, particularly since the Court determined

that the record it reviewed (exhibits collected through

November 1983) was a sufficient basis for the final rule.

Thus evidence collected subsequent to that time was mere-

ly cited as additional substantiation for the expansion.

The revised final rule expanded the scope of industries

covered from just the manufacturing sector to all in-

dustries where employees are exposed to hazardous chem-

icals. As OSHA stated at the time, the Agency has evi-

dence to indicate that there is chemical exposure in every

type of industry and thus employees in all industries must

have protection under the rule. (See 52 FR 31858.)

As noted earlier, although the standard was issued as a

final rule, OSHA invited interested parties to submit in-

formation, data or evidence regarding the feasibility or

practicality of the provisions as written when applied to

the non-manufacturing sector as well as any recommenda-

tions for further modification. A 60 day period was

established for such comments, and it ended on October

23, 1987. A total of 136 comments were received (39 of

them were received after the deadline), and entered into

Docket H-022D. A variety of opinions were expressed in

the comments regarding a number of issues, however,

most of the comments did not contain data or evidence

concerning either feasibility or practicality. Many of the

comments were questions or requests for classification of

the provisions.

OSHA is proposing some modifications it believes are

appropriate to address concerns raised and clarify the re-

quirements. The Agency is also providing clarification re-

garding other issues in this preamble discussion. The

Agency is, of course, always prepared to respond to any

specific questions from the regulated community regard-

ing compliance. To this end, OSHA has appointed a

Hazard Communication Coordinator in each Regional

Office to whom such questions should be directed. In-

structions to OSHA's compliance staff regarding enforce-

ment of the HCS also include interpretations and many

employers have found these documents to be useful to

them in complying with the rule. These instructions are in-

cluded in the docket as Ex. 4-24, and copies may be ob-

tained from OSHA's Publication Officer, (202) 523-9667.

A booklet summarizing the rule’s provisions is also

available and may be used by employers in training

workers regarding the requirements of the rule (the

publication number is OSHA 3084 Revised).

In addition to the comments submitted to OSHA, the

Office of Management and Budget (OMB) convened a

public meeting under the Paperwork Reduction Act (44

U.S.C. Chapter 35) to address the information collection

requirements of the expanded rule. The transcript of the

OMB public meeting (which was held on October 16,

1987) is entered in the docket as comment 5-76, and other

relevant documents (e.g., copies of statements, etc.) are

entered in Exhibit 6. (In addition, the transcript of an

April 2, 1987, public meeting on the information collec-

tion requirements for the manufacturing sector is Ex. 4-3).

The majority of the participants in OMB's October 16

meeting submitted written comments to OSHA as well, so

there is considerable duplication in Exhibit 6 of opinions

that had already been expressed by the same parties in

other parts of the rulemaking record.

In a letter sent to the Department of Labor on October

28, 1987, and subsequently published by OSHA in the

Federal Register on December 4, 1987 (52 FR 46075) (EX.

4-67), OMB, under the authority of the Paperwork Reduc-

tion Act (44 U.S.C. 3501 er seq.), disapproved certain in-

formation collection requirements in the expanded scope

rule, as of the rule’s effective date (May 23, 1988), based

upon the record of the October 16 public meeting and the

previous meeting on April 2, 1987 regarding the intorma-

tion collection requirements for the manufacturing sector,

as well as OSHA's preamble to its August 24 rule and its

justification submitted formally under the Paperwork

Reduction Act. The October 28 letter stated that OMB

disapproved: (1) The requirement that material safety data

sheets be provided on multi-employer worksites; (2)

coverage of any consumer product that falls within the

“consumer products” exemption included in section

311(e(3) of the Superfund Amendments and Reauthoriza-

tion Act of 1986; and (3) coverage of any drugs regulated

by the Food and Drug Administration in the non-

manufacturing sector. In addition, OMB determined that

OSHA should reopen the rulemaking on the HCS to con-

sider alternatives to the definition of “article” which was

included in both the original and revised final rules. Last-

ly, OMB conditioned paperwork approval upon OSHA's

consulting with the U.S. Small Business Administration

and the Department of Commerce in order to develop a

plan for a Federal administrative effort that will provide

assistance to the regulated industries to alleviate paper-

work burdens and costs. For a complete description of

OMB’'s rationale for these determinations, see the Federal

document will only summarize the positions taken by

OMB.

On April 23, 1988, OMB extended its approval of all in-

formation collection requirements in the HCS through

April 1991, except that OMB continued to disapprove the

three provisions previously disapproved, 53 FR 15033.

OMB’s approval of the existing definition of “article” was

limited to the clarification included in a January 14, 1988,

letter from Assistant Secretary for Occupational Safety

and Health John Pendergrass to OMB, which stated that

“absent evidence that releases of such very small quantities

could present a health hazard to employees, the article ex-

ception to the rule’s requirements would apply.” In

response to commenters who requested that OMB not ex-

tend approval to any requirements in the non-

manufacturing sector, OMB also stated:

The concerns of these commenters are largely based

on the possibility that the standard and OMB’s deci-

sion under the PRA will change dramatically as a

result of the rulemaking. Although change is always

possible, any such change would be fully considered

during the rulemaking process. Of course, in order

for OMB to grant PRA approvals, any changes must

offer sufficient practical utility to justify any in-

cremental paperwork burden they impose, including

the burden of revising already-developed written pro-

grams. Moreover, as stated above, we are continuing

to disapprove the previously-disapproved provisions;

the rulemaking should of course conform the rule to

these disapprovals.

In accordance with the Paperwork Reduction Act and

the implementing regulations for that Act (S CFR

1320.13(g) and 1320.14(f) and (g)), OSHA is reopening the

rulé on all of the issues raised by OMB in its letter in order

to have an opportunity to fully discuss the complete cur-

rent record on each item, as well as to collect additional

data from the public. The issues and alternatives for deal-

ing with them are described further below. OSHA is also

proposing certain minor modifications, described below,

and invites comment on them as well.

Regarding OMB’s requirement that OSHA develop a

plan to assist the regulated community with the paperwork

associated with the HCS, the Agency is in the process of

developing compliance assistance materials. These include

OSHA 3084, a booklet explaining the provision. of the

rule, and a compliance kit designed to help employers

come into compliance. The compliance kit will be made

available through the Government Printing Office within

a few months. A press release will provide information

about obtaining a copy at such time as it becomes

available. For further information, please contact OSHA's

Office of Information and Consumer Affairs, (202)

§23-8151. |

The revised final rule has been challenged in the U.S.

Court of Appeals by the Associated Builders and Contrac-

tors, National Grain and Feed Association, Associated

General Contractors of Virginia, Associated General Con-

tractors of America, and United Technologies Corpora-

tion. A number of interested parties have intervened in

these cases as well. The challenges are in the preliminary

stages of adjudication at this point, and generally involve

the appropriatefiéss of OSHA's publishing a final rule in

response to the Third Circuit’s order.

Although these cases were originally consolidated in the

U.S. Court of Appeals for the District of Columbia Cir-

cuit, they were transferred to the U.S. Court of Appeals

for the Third Circuit on May 20, 1988. The cases were

transferred to the Third Circuit because the “revised

{HCS] was promulgated in response to orders by the Third

Circuit * * * and petitioners have raised issues similar to

those already considered by that court.”

On June 24, 1988, the Third Circuit granted a stay of

the standard as it applies to the construction industry (29

CFR 1926.59) pending the outcome of the litigation

challenging the rule. The rule is in effect for all other

employers in both the manufacturing and nonmanufactur-

ing sectors. OSHA published a notice in the Federal

fected employers further information regarding the ap-

plicability of the stay and enforcement of the rule.

In addition to these challenges of the revised HCS, the

United Steelworkers of America, AFL-CIO-CLC, and

Public Citizen have filed a motion with the Third Circuit

requesting the court to order that OSHA enforce all of the

revised HCS including the three requirements OMB disap-

proved under authority of the Paperwork Reduction Act.

OSHA will continue to abide by the OMB decision and

will not enforce the disapproved requirements unless

otherwise ordered by the Court.

Advisory Committee on Construction Safety and

Health (ACCSH). As discussed in the preamble to the

August 1987 final rule (52 FR 31858-59), the ACCSH

reviewed a draft notice of proposed rulemaking to expand

the scope of the HCS to construction on June 23, 1987.

The ACCSH went through the NPRM line-by-line, mak-

ing recommendations to adapt it to construction industry,

i.e., the document with the recommended changes con-

stituted an ACCSH recommended standard for hazard

communication. A number of the recommendations were

adopted (e.g., the definition of workplace was modified to

include job sites or projects; the written hazard com-

munication program requirements were amended to clear-

ly state that the programs are to be maintained at the site).

As this NPRM addresses issues that affect construction,

OSHA transmitted a draft of it to the ACCSH for review

and comment. In a meeting on March 30, 1988, the

ACCSH did not provide specific recommendations on the

NPRM. The ACCSH reiterated its desire to have a sep-

arate standard for construction, and appointed a subcom-

mittee to make further recommendations to the Assistant

Secretary. However, the ACCSH also reaffirmed that the

standard as written should be implemented as scheduled

on May 23, 1988.

The three primary issues in this NPRM that affect con-

struction —the definition of “article,” the coverage of con-

sumer products, and the maintenance of material safety

data sheets on multi-employer worksites — were all pre-

viously considered by the ACCSH on June 23, 1987.

With regard to the definition of “article,” the ACCSH

recommended that the definition state that vapors, mists,

gases, and fumes are not to be considered articles (Tr.

97-8). As OSHA explained during the meeting, those types

of materials do not meet the definition in any event, and

would not be considered articles. Thus there is no need for

that particular modification. There were no further com-

ments on the definition or its application to the construc-

tion industry during that meeting.

The ACCSH also reviewed OSHA's proposed exemp-

tion for consumer products, i.e., that consumer products

be exempt where the employer can demonstrate it is used

in the workplace in the same manner as normal consumer

use, and which use results in a duration and frequency of

exposure which is not greater than exposures experienced

by consumers. A motion was initially made to modify the

exemption to allow consumer products used “as approved

for consumer use, and which will not result in any dura-

tion or frequency of exposure which is greater than ap-

plicable threshold limit values for any hour of use.” Tr.

81. After further discussion regarding the lack of a

mechanism for “approval” for consumer use that would

apply in this situation, and the lack of threshold limit

values for the majority of chemicals in the workplace, the

ACCSH voted to approve an amended exemption which

reads “where the employer can demonstrate i is used in

the workplace in the same manner as recommended for

consumer use, and which will not result in any duration

and frequency of exposure, which is greater than ex-

posures experienced by consumers.” Tr. 90.

The ACCSH also reviewed the requirement for

maintenance of material safety data sheets on multi-

empl. yer worksites, and did not object to such a provision

or indicate that it would be infeasible or unnecessary to

have such a requirement. In fact, the committee further

recommended that it be made explicit that written pro-

grams be maintained at the worksite, a recommendation

that OSHA adopted.

il. Summary and Explanation of the Issues and the Provisions of the

Notice of Proposed Rulemaking

The regulatory text presented in this document only ad-

dresses the proposed modifications, rather than reprinting

the entire standard and incorporating the proposed

changes. Since the HCS is lengthy and complicated,

OSHA believes that this will make it easier for interested

parties to identify the proposed modifications and provide

appropriate comment. When the final rule is promulgated,

OSHA will reprint the entire text including the modified

provisions. 2

The discussion which follows is also limited primarily to

the proposed changes and related issues. It does not pro-

vide a complete summary and explanation of all of the

provisions of the rule—for such information interested

parties should refer to the preambles of the original (48 FR

$3334-40) and revised ($2 FR 31860-67) final rules. There

are also discussions of alternatives to the proposed

modifications which have been suggested to OSHA.

OSHA is inviting comment on these as well as the

regulatory text itself. While the purpose of this rulemaking

is principally to resolve the issues presented by the pro-

posed and alternative provisions, OSHA is also interested

in receiving comment on other issues that may be reiated

to the proposal. In order to assist OSHA in its develop-

ment of the final HCS in the nonmanufacturing sector,

comment will also be accepted and considered concerning

the entire rule’s application to the nonmanufacturing sec-

tor.

As most interested parties are aware, the rulemaking

record on this standard is quite extensive, and all of the

material submitted to date will be considered in develop-

ment of the new final rule. It is therefore not necessary, or

desirable, to repeat comments previously provided unless

there is new data, evidence or other information available

concerning the arguments made.

In reopening the record, OSHA recognizes that it is not

operating “on a clean slate.” In developing the existing

standard, OSHA had the benefit of an extensive eviden-

tiary record. In addition, the Agency's experience gained

under the original standard, as well as under State stand-

ards, some of which already applied to the nonmanufac-

(uring sector, further supported OSHA's current standard.

As explained in detail below, OSHA continues to believe

that the record substantially justified the Agency’s

regulatory choices, and the information presented to

OSHA after the standard was issued has, by and large, not

convinced OSHA that significant changes are warranted

to comply with the OSH Act.

In this rulemaking, OSHA is seeking additional infor-

mation on whether these regulatory choices also meet the

criteria of the Paperwork Reduction Act. If information

collected in the course of this rulemaking responds to the

concerns raised by OMB on these issues in its October 28,

1987, letter, OSHA will request that OMB reconsider its

paperwork decision on these issues. OSHA will also con-

sider requesting paperwork approval for other options

substantially supported by the record, as well as conform-

ing the final rule to OMB’s paperwork decisions.

OMB has published implementing regulations at §5 CFR

1320.4(b) which state that, to obtain OMB approval of a

collection of information, an agency shall demonstrate

that it has taken every reasonable step to ensure that:

(1) The collection of information is the least burden-

some for the proper performance of the agency's functions

to comply with legal requirements and achieve program

objectives;

(2) The collection of information is not duplicative of

information otherwise accessible to the agency; and,

(3) The cc“tection of information has practical utility.

Commenters to the record should focus on these criteria in

this rulemaking.

OSHA will fully comply with the Paperwork Reduction

Act, which prohibits agencies from “conducting or spon-

soring” a collection of information without OMB ap-

proval. Hence, the provisions disapproved by OMB will be

neither effective nor enforceable until OSHA completes

this rulemaking.

It should be noted, however, that OSHA retains “almost

unlimited discretion to devise means to achieve the Con-

gressionally mandated goal.” United Steelworkers of

Amerita v. Marshall, 647 F.2d 1189, 1230 (D.C. Cir.

1980), cert. denied, 453 U.S. 913 (1981). Accord, Building

and Construction Trades Dept., ALF-CIO v. Brock, 838

F.2d 1258, 1271 (D.C. Cir. 1988). The expectations of the

manufacturing sector, which has been subject to the HCS

since 1985, are settled, as are those of the nonmanufactur-

ing sector, which has been preparing to comply with the

present standard since August 1987, and with the paper-

work requirements as approved by OMB since October

1987. Therefore, OSHA does not expect the standard to

further change significantly unless the Agency is presented

with substantial evidence that a regulatory modification ts

clearly necessary, either because the present standard is

demonstrably infeasible in a specific respect, or because

the proposed alternative would significantly increase the

standard’s intended safety and health benefit or signifi-

cantly improve its cost-effectiveness. Employers must plan

accordingly to fulfill their compliance obligations under

the standard as it is currently approved and should not an-

ticipate undue delay in its enforcement.

Comments submitted should clearly identify the provi-

sions being addressed, the rationale for the position taken,

and data or evidence in support of that rationale.

The discussion which follows is organized by paragraph

of the standard for ease of reference. It is suggested that

comments submitted be presented in the same fashion.

Food, drugs, cosmetics, and alcoholic beverages. \n the

revised final rule, OSHA included an exemption for food,

drugs, cosmetics, or alcoholic beverages in a retail estab-

lishment which are packaged for sale to consumers (para-

graph (b)(6)(v)). This exemption recognized that even

where these chemicals are hazardous chemicals (and many

are not, particularly in the area of food items), they pre-

sent little or no hazard to employees when they are in final

packaged form for sale to consumers. This exemption ef-

fectively limited coverage of many retail establishments

which only have hazardous chemicals in this form, /.e.,

packaged for sale to consumers. But it did not exempt

these products when they are being used in a retail estab-

lishment and thus exposing employees —such as beauty

products being used in a salon.

OSHA has received comments and questions about the

application of this exemption from both businesses dis-

tributing to retail food establishments (see, Ex. 5-97) and

the retail establishments themselves (see, Ex. 5-5). As

stated in the preamble to the revised final rule, if a product

is exempted downstream, a distributor has no responsi-

bility for providing a MSDS on that product to the retail

distributor. “In addition, since these products are ex-

empted, employers which package them for retail sale

would not have to furnish material safety data sheets to

distributors receiving the products.” 52 FR 31862.

OSHA is proposing a further modification to this ex-

emption which both clarifies and extends it to other food

and alcoholic beverage products in retail establishments

which are being prepared for consumption by consumers.

Thus food which is used for cooking meals to be sold to

customers would be exempt, as would alcoholic beverages

which are sold by the glass and thus prepared for con-

sumption rather than “packaged” for consumer use.

Although OSHA believes that most such products in terms

of food items would not be hazardous under the rule in

any event, it appears that some manufacturers are never-

theless providing material safety data sheets for such items

as aflatoxin in peanut butter used in a restaurant. To en-

sure such interpretations are not made, and that rjaterial

safety data sheets are not unnecessarily being provided for

such items, OSHA is proposing this modification to the

exemption and inviting comment on the proposed

language.

Consumer products. One of the principles upon which

the HCS is built is that employees are entitled to informa-

tion regarding any chemical which is hazardous and to

which they are potentially exposed. The type of use this

product is intended for is irrelevant —the risk being ad-

dressed is exposure to a chemical without knowing what

the hazards and appropriate protective measures are. That

being the case, the 1982 NPRM contained no exemptions

for any “types” of chemicals. The exemptions which were

in the original final rule were based upon comments sub-

mitted to the rulemaking record after that proposal.

OSHA limited the exemptions to situations where other

regulatory programs adequate!y addressed the problems

involved (e.g., labeling exemptions for those products

labeled in accordance with another Federal agency's re-

quirements), or where the hazards did not result from

workplace exposure.

in the area of consumer products, the original final rule

included an exemption for additional labels on such prod-

ucts when they are labeled in accordance with the require-

ments of the Consumer Product Safety Commission

(CPSC). CPSC’s requirements for labeling of hazardous

substances are for the purpose of protecting consumers

when such products are used in the home, the school, and

recreational facilities (15 U.S.C. 2052(a)(1)). The Federal

Hazardous Substances Act, 15 U.S.C. 1261 ef seq., and

regulations issued under that Act by CPSC are not de-

signed to protect workers. See American Petroleum Insti-

tute v. OSHA, 581 F.2d 493, 510 (Sth Cir. 1978), aff'd on

other grounds sub. nom. Industrial Union Dep't. v.

American Petroleum Institute, 448 U.S. 607 (1980).

Consumer products generally do not include the type of

specific hazard information OSHA would require on the

labels of containers of hazardous chemicals which are

shipped. Although some consideration is given to chronic

hazards, the basic emphasis is on acute effects. In addi-

tion, the labels focus on precautiofiary statements and

routes of exposure rather than informing the user of the

specific hazards. For example, a label for lead solder pur-

chased in a hardware store indicates that it is “fatal if

swallowed” and “causes severe burns,” but gives no indica-

tion of the fact that lead causes not only acute lead poison-

ing but also has severe effects on a number of body

systems, including damage to blood-forming, nervous,

and reproductive systems (see, OSHA's lead standard, 29

CFR 1910.1025). Furthermore, the primary route of entry

for occupational exposure to lead would normally be in-

halation—the consumer label does not indicate that in-

halation of fumes generated when soldering are of con-

cern. (Ex. 4-71). Conversely, a properly prepared MSDS

for the same material will indicate the full range of health

effects, the appropriate protective measures, the fact that

there is an OSHA standard for the material with a per-

missible exposure limit, and other useful information for

both the employer and the employee being exposed.

OSHA nevertheless decided to permit the CPSC labels

to suffice so as not to disrupt the extensive labeling con-

ducted in accordance with those rules. OSHA believed

that this could be justified on the basis that some informa-

tion is provided on the labels that would be useful to

workers, and that the requirement for MSDSs would pro-

vide what information is necessary to supplement the

labels. 48 FR $3289. This additional information is critical

to ensuring that training can be properly conducted, and

that adequate protective measures are used in the work-

place.

OSHA is not preempted from modifying the labeling re-

quirements for those products covered by CPSC that may

also be found in the workplace. 15 U.S.C. 2080. Where

products are used in both industry and the home “there

may be dual, or overlapping jurisdiction between the

Secretary of Labor under OSHA and the Commission

under the Consumer Product Safety Act.” W. Kimble,

Federal Consumer Product Safety Act, 337 (1975). “Dit-

ferent standards may * * * be applied to eliminate or

reduce a hazard to the consumer than are applied to

eliminate or reduce the same hazard as it confronts the

* * * workman * * * /d. As the Fifth Circuit of the U.S.

Court of Appeals found when considering labeling re-

quirements for benzene, “[A}lthough an existing require-

ment for labeling under another act may affect the reason-

able necessity for an OSHA requirement” section 4(b)(1)

of the OSHA Act does not prohibit OSHA from requiring

containers of hazardous chemicals to bear the warning

labels authorized by section 6(b)(7) when the CPSC re-

quires labels on the same products. AP/ v. OSHA, 581

F.2d at 510. Therefore, OSHA is free to impose require-

ments determined to be necessary to protect employees

from the hazards of products that may also be considered

consumer products regulated under the requirements of

the CPSC.

Upon considering what information is necessary for the

protection of workers exposed to those so-called consumer

products in the workplace, OSHA decided that protection

of workers would be served by allowing the CPSC labels

to suffice, but requiring MSDSs and training as for any

other hazardous chemicals. There appears to be some mis-

conception that by virtue of being permitted to be mar-

keted to consumers, consumer products are inherently safe

and don’t require any additional information be given to

workers using them. This certainly is not the case.

The Consumer Product Safety Commission (CPSC), in

its National Electronic Injury Surveillance System

(NEISS), compiles estimates of product-associated in-

juries based on a statistically significant sample of in-

cidents reported to institutions with emergency treatment

department. Information regarding work-related injuries

treated in emergency rooms has subsequently been pro-

vided by CPSC to the National Institute for Occupational

Safety and Health (NIOSH). See Ex. 4-77.

These work-related data are total numbers of chemical

injuries, and are not collected in such a way that the con-

sumer product injuries in the workplace can be separated

from other chemical product injuries. The CPSC version

of the data is reported by type of product, while the

NIOSH work-related data is grouped by source of injury.

Nevertheless, much information regarding reported in-

juries can be derived from the data as presented, and give

some indication of the numbers of serious injuries related

to the use of chemicals. Since these data only deal with in-

juries which require emergency room treatment, it can be

assumed that they are a small subset of the total number of

injuries which occur.

According to the CPSC, the national estimate for

emergency room treatments of injuries related to paints,

varnishes, and shellacs is 10,712 and 75% of these injuries

occur in adults from ages 15 through 64, an age range

which would encompass adults who work. At least 5% of

these injuries result in hospitalization. National estimates

for other types of chemical products which would also be

found in the workplace include: 7530 injuries related to

adhesives (51% of them in the adult working age cate-

gories); 3186 injuries related to lubricants (71% in the

adult working age categories); 2977 related to drain

cleaners (63% working age adults); 1882 related to auto-

motive chemicals (69% working age adults); and 5584

related to laundry soaps or detergents (52% working age

adults). There are many other products for which inju. ies

are reported and which would be expected to be found in

the workplace. These numbers indicate that adults of

working age are being injured through the use of con-

sumer products, whether in the home or in the workplace.

In workplaces where these products are being used more

frequently or for longer periods of time, the risk of injury

increases. Appropriate communication of hazards and

protective measures decreases that risk of injury.

The NIOSH data indicate that a total of 136,212 work-

related chemical injuries were estimated to have been

treated in emergency rooms in 1986. The sources of in-

juries included in this total were chemicals and chemical

compounds (solids, liquids, gases): 102,428; coal and

petroleum products; 23,532; and soaps, detergents, clean-

ing compounds not classified elsewhere: 10,252. There

were other categories of sources of injuries that had

chemical product exposures in them, but these three were

expected to be the ones of cost significance. As mentioned

above, it is not possible to determine which of these work-

related injuries result solely from consumer products.

However, in categories such as soaps, detergents, and

cleaning compounds, it can reasonably be assumed that a

number of them were consumer products.

Many products used industrially are also sold and used

as consumer products. Thus, exempting such products is

in essence exempting them because of the method of dis-

tribution for them, i.e., that they are generally sold in

retail establishments, rather than through wholesale dis-

tribution systems. This is not an appropriate rationale for

such an exemption since it does not consider either ex-

posure or hazardous nature. Of particular concern is that

the CPSC label is designed to protect consumers under

normal conditions of consumer use, or reasonably fore-

seen misuse, and is frequently directed towards protection

of children unintentionally exposed in the home, rather

than being directed towards protection of workers exposed

repeatedly, and to potentially larger concentrations of the

material. In fact, a number of consumer product labels

recognize this difference in exposure and note on the label

either that the product is not intended to be used in the

workplace (Ex. 4-64), or that a material safety data sheet

should be acquired if it is used in the workplace (Ex. 4-71).

It is also important to note that the record overwhelm-

ingly supports the need for a comprehensive hazard com-

munication program, comprised of labels, material safety

data sheets, and training. In 1981, OSHA published and

later withdrew a NPRM which was a labeling standard — it

had no provisions for development of material safety data

sheets or for training. One of the primary reasons for the

withdrawal was the lack of support for a rule which relied

only on label information. In fact, only one commenter on

the 1982 NPRM believed that the MSDS should not be the

primary source of information on the chemical (H-022 Ex.

19-49), whereas numerous respondents endorsed the

MSDS provisions and role in hazard communication as

being important and necessary (se, ¢.g., H-O22 Exs. 19-11,

19-62, 19-75, 19-91, 19-119, 19-156, 19-177, and 19-207).

For example, the Chemical Manufacturers Assocation

(Ex. 19-91) stated that: “[T])he proposed standard appro-

priately makes the MSDS, rather than the actual container

in the workplace, the source from which employees and

their representatives may obtain detailed information re-

garding potentially hazardous substances used in the

workplace.” Similarly, the American Petroleum Institute

(Ex. 19-111) stated that “labels may not always be the most

effective means for communicating the potential hazards

of a work area * * *” and that “MSDSs constitute a vital

means of communicating safety and health hazards pre-

sented by particular chemicals and mixtures to employer:

users ** *” And American Cyanamid Company also

agreed that “the use of the MSDS as the primary source of

data for properties of commercial chemicals is a worthy

part of the proposed regulation * * *.” (Ex. 19-119.)

OSHA thus did not exempt consumer products from

any provisions of the original final rule other than label-

ing. This was an explicit recognition by the Agency of the

greater potential for exposure in the workplace, and the

lack of complete information on consumer product labels

to address such situations (48 FR $3289):

OSHA recognizes, however, that there may be

situations where worker exposure is significantly

greater than that of consumers, and that under these

circumstances substances which are safe for con-

templated consumer use may pose unique hazards in

the workplace. For this reason, the standard’s exclu-

sion is limited to labeling. It does not exempt

employers from the material safety data sheet and

training requirements of the standard with respect to

any of these substances, provided of course that the

substance otherwise meets the standard’s definition of

hazardous chemical. Moreover, it should be stressed

that these labeling exclusions are for the enumerated

substances only. To the extent that any employer uses

other chemicals, such as in the manufacture or proc-

essing of these substances, they are fully subject to the

requirements of this standard.

During the implementation of the original final r

OSHA determined that its enforcement aie reosndiag

consumer products would focus on the type and extent of

usage (see, OSHA's instructions to compliance officers for

enforcement of the HCS, Ex. 4-24):

A common sense approach must be employed

whenever a product is used in a manner similar to

which it could be used by a consumer, thus resulting

in levels of exposure comparable to consumer ex-

— Ly a and duration of use should be

con . For example, it may not be to

have a data sheet for a can of cleanser fs pange dt

the sink in an employee restroom. However, if such

cleanser is used in large quantities to clean process

equipment, it should be addressed in the Hazard

Communication Program.

| This appeared to OSHA to be a reasonable accommoda-

tion for employers who really do use consumer products in

the manner intended, and with the same frequency and

duration of exposure as would be experienced as con-

sumers. OSHA has had no problems in implementing this

enforcement policy, and it has been our experience that

covered employers understand it and are able to comply.

Therefore, although it is a policy which decreases the

amount of information available to some employees

covered under the rule, OSHA felt it could be justified

based on the fact that under the same circumstances in the

home the same type of information would be available to

that individual for protection. Many employers have told

OSHA that consumer products are included in their

hazard communication programs regardless of the en-

forcement policy of the Agency because they believe that

all hazardous chemicals should be included in an ap-

propriate hazardous materials management program.

OSHA recognized that many more non-manufacturers

would use consumer products than would be found in

manufacturing facilities, and that the method of obtaining

them might more likely be from retail distributors than

wholesale. Thus the ANPR included questions regarding

the use of such products, and the means of obtaining

them. Relatively few responses were received. However,

the responses did confirm that in many cases the use of

consumer products results in significant exposures that

warrant more information being available than that which

appears on a consumer product label. For example, Daniel

Construction Company responded to the questions as

follows (Ex. 2-59):

The most common “consumer products” used in

the construction industry are wood and wood prod-

ucts, caulking, and aerosol cans of spray paints,

cleaners, lubricants, and solvents. These products are

not typically used differently than consumers do.

That does net mean that employees cannot be overex-

posed to the ingredients. For example, a 16-ounce

spray can of paint used in a 10 x 10 x 10° room can

produce a concentration of solvent that is more than

ten times the acceptable exposure limit.

Of course a consumer product label would not normally

indicate that there is a permissible exposure limit for a

solvent present in the paint since this information is un-

related to consumer use and exposure. However, a MSDS

for the product would be required to include such infor-

mation which will enable the employer to ensure that

employees are properly protected in a situation as that

described by Daniel Construction Company. In fact, the

CPSC has recommended the use of MSDSs for products

they cover in school laboratories (Ex. 4-56), recognizing

that additional information is desirable in these types of

exposure situations. “Material safety data sheets should be

obtained on each chemical delineating particular hazards

or handling procedures.” “Have a material safety data

sheet on hand before using a chemical.”

Similarly, the American Gas Association (Ex. 2-83) in-

dicated that use of consumer products could result in dif-

ferent exposure levels than those encountered during con-

sumer use:

It could occur —not because of different use, but

because the use by employees is for prolonged periods

of time. An average consumer may use a cleanser

several times a week to clean the kitchen or bathroom

floor, whereas a gas company employee may use the

same cleanser every day to clean a gas facility.

The Massachusetts Institute of Technology (MIT) (Ex.

2-120. also indicated that their employees are exposed to

consumer products in greater amounts than consumers

would be, including paint and thinners used by the

painters, printing fluids used by the graphic arts services,

cleaning and polishing chemicals used by the custodians,

lawn and garden chemicals used by the grounds mainte-

nance crew, and lubricating sprays and other maintenance

products used by mechanics/electricians. MIT obtains

MSDSs from vendors to ensure employees are properly

protected from these materials. Mountain Bell (Ex. 2-164)

also confirms that consumer product exposures may be

greater in its industry, particularly “ * * * where products

are used on an extensive basis such as in automotive opera-

tons, | janitorial operations, and copying operations

A few respondents felt that the consumer product label

should be enough information (Exs. 2-75, 2-79, 2-99,

2-107, and 2-1 16). Others, however, noted that employees

are not getting enough information regarding these prod-

ucts and that MSDSs should be made available. For exam-

ple, Economics Laboratory, Inc., a manufacturer of con-

sumer products for cleaning and sanitizing, suggested (Ex.

2-67): ‘

In the use of cleaning and sanitizing products, a

principal point of worker exposure is during the

transfer of concentrate from the original container to

prepare a use solution. We supply products labeled as

per ANSI and/or FHSA, but we have seen instances

of deficient labeling on the products of some other

manufacturers. We now send to all customers in these

sectors an MSDS for every product they purchase.

Many of our customers now use the labels, MSDS

and other aids to train employees, but a formal re-

quirement would increase that number throughout

the industry.

The Adhesive and Sealant Council, a trade association

which represents manufacturers of materials that may be

marked as consumer products, also addressed this issue

(Ex. 2-109):

* * * The Council is concerned that in certain cases

hazard information may not reach employees of

manufacturers and nonmanufacturers. ASC members

are aware of cases in which consumer products are

purchased from retailers or distributors in consumer

quantities but are used in the workplace. Under such

circumstances the original manufacturer is not made

aware of the use of its consumer products in the

workplace. Thus, some workers may lack needed

hazard information unless they or their employer at-

firmatively and voluntarily make an effort to obtain

and promulgate the information.

There are, of course, safety requirements appli-

cable to consumer products under the Consumer

Product Safety Act, and other federal laws, but these

do not contain broad workplace safety requirements

beyond standards and labeling, such as material safe-

ty data sheets. The present OSHA docket has not

been opened as to this issue. However, ASC believes

the problem could be greater with regard to non-

manufacturer distribution than with direct manufac-

turer distribution * * *

One further comment submitted by an employee repre-

sentative summed up the situation by stating that when a

product is used by a professional in the workplace, it is no

longer a “consumer” product regardless of the fact that a

consumer can purchase the same product (Ex. 2-199).

| OSHA decided to incorporate into the revised final rule

its existing enforcement policy which is tied to type and ex-

tent of exposure (52 FR 31878; paragraph (b)(6)(vii)):

Any consumer product or hazardous substance, as

those terms are defined in the Consumer Product

Safety Act (15 U.S.C. 2051 ef seq.) respectively,

where the employer can demonstrate it is used in the

workplace in the same manner as normal consumer

use, and which use results in a duration and frequency

of exposure which is not greater than exposures ex-

perienced by consumers * * *.

OSHA further stated that this exemption “strikes a

balance between the practical considerations of acquiring

and maintaining material safety data sheets on CPSC

regulated producis which employees are exposed to at

home as well as at work, and the worker's need for more

hazard information than a CSPC label when exposures are

greater Or more frequent than typical public use of the

chemical would generate.” 52 FR 31863. OSHA had also

examined the existing State rules in the area of right-to-

know, and found that many had consumer.product ex-

emptions that were related to the type and extent of usage.

(See, e.g., Illinois, 48 Ill. Rev. Stat. s1401 (consumer

goods exempted “provided that employee exposure to such

consumer goods is not significantly greater than consumer

exposure occurring during the principal consumer uses ot

the consumer goods”); Maine, 26 M.R.S.A. $1709-1725 as

amended (exempts consumer products and foodstuffs “to

which, in the employer’s knowledge, employee exposure ts

not significantly different from that of the general public

during foreseeable use of the substance”); Massachusetts,

Chapter 111F of Massachusetts General Laws (exempts

consumer goods which are not carcinogens, mutagens,

teratogens, neurotoxins, or “extraordinarily hazardous”

substances and which are “used in the workplace in such a

manner that employee exposure is equivalent to exposures

resulting from consumer usage”). Other State rules are

consistent with the original HCS and have no exemptions

for consumer products (see, e.g., Arizona, Kentucky,

South Carolina).

There were some comments submitted on the coverage

of consumer products following the publication of the re-

vised final rule. A number of them felt that they could not

define what exposures in the workplace would be compar-

able to consumer exposure, and that the rule should ex-

empt such exposures unless they are “significantly” greater

than consumer exposure or that such products should be

completely exempted (Exs. 5-53, 5-72, 5-88, 5-93, 5-94,

and 5-97). As we have stated earlier, a common sense ap-

proach is required in making these determinations, and

most employers we have dealt with clearly know whether

the use of such products is unusual or frequent. However,

we are inviting further comment on the issue of adding the

word “significantly” to the consumer product exemption

to modify “greater.”

Another suggestion submitted (Exs. 5-84, 5-93) was to

use the same consumer product exemption used by Con-

gress in the community right-to-know provisions of the

Superfund Amendments and Reauthorization Act (SARA)

of 1986, Pub. L. 99-499 (Ex. 4-16), which is being imple-

mented by the Environmental Protection Agency (EPA).

The exemption would then be for “any substance to the

exient that it is used for personal, family, or household

purposes, or is present in the same form and concentration

as a product packaged for distribution and use by the

general public.” As this exemption is also not related to thx

extent of employee exposure—which is the concern oi

OSHA in the HCS—it is not appropriate for this rule.

The legislative history for SARA does not discuss the

household or consumer product exemption. OSHA’s rule

preceded the SARA legislation, and it can be argued that

the exemptions in SARA were intended by Congress to ad-

dress the different needs of community right-to-know ver-

sus worker right-to-know. Community right-to-know

under SARA entails informing the general public and

emergency response facilities about chemicals in their

neighborhoods that could cause hazardous conditions dur-

ing emergency situations. The HCS involves informing

employees about the chemicals they are potentially ex-

posed to on a day-to-day basis as a result of their work.

Exemption of consumer products under SARA was not a

determination by Congress that such coverage is unneces-

sary in the workplace.

The National Paint and Coatings Assocation (NPCA)

Suggested that it is too costly to provide MSDSs to paint

contractors and retail establishments and that they there-

fore should not be required for consumer product paints

(Ex. 2-75). Alternatively, NPCA suggested containers of

one gallon or less should be exempted. As has already been

described, OSHA believes that the only appropriate

criteria for determining whether a chemical is covered is

the existence of a hazard and the potential for exposure.

Both of these criteria are met for many paint products. As

was described above, use of even a 16 ounce spray can of

paint can result in employee exposures of ten times the

permissible exposure limit, so the size of the container is

not the determining factor.

The NPCA indicated that it would be difficult to com-

ply due to the large numbers of products involved and the

multiplicity of distributors. However, there are already a

number of States which require MSDSs for such products,

and it is our understanding that many employers in con-

struction have been able to obtain MSDSs for consumer

product paints from their vendors. Furthermore, there is

evidence in the record that paint producers customarily

distribute documents referred to as “technical data sheets”

which prescribe methods of application and other use-

related information, including, in some situations, brief

indications of hazards (Ex. 4-60). These technical data

sheets are apparently supplied to distributors to provide

information regarding the products that does not appear

on the product labels. It appears to OSHA that if these

sheets can efficiently be distributed for paint products,

then MSDSs can as well. Alternatively, the information re-

quired on a MSDS could merely be added to the technical

data sheets. It certainly cannot be argued that labels alone

provide the same type of information that a MSDS would.

An issue that is related to the coverage of consumer pro-

ducts, and is undoubtedly the genesis of some of the

recommendations to eliminate such products from cover-

age, is the distribution of consumer products in com-

merce. It is important to point out that the vast majority

of consumer products are not covered by this rule. Only

those which are hazardous are potentially covered, and

within that group, only those which are used in the work-

place. Producers of the materials which, while marketed

to consumers, are likely to be sold to employers and used

in the workplace are well aware of that potential market.

(See, e.g., Ex. 2-148.) Thus manufacturers of materials

used in construction, graphic arts, and clearning opera-

tions, are aware that their products have industrial ap-

plications even when sold as consumer products. MSDSs

have already been prepared and distributed for many, if

not most, of these products. Manufacturers are required

to have MSDSs for their own workers, and have already

been required to distribute such MSDSs to non-manu-

facturing customers in a significant number of «tates with

right-to-know rules. Furthermore, most manufacturers

have and make available MSDSs because of product lia-

bility concerns separate and apart from any regulatory re-

quirements. This was certainly demonstrated in the record

by the large number of manufacturers that produced

MSDSs in the absence of such requirements prior to prom-

ulgation of the original HCS. The sealed container provi-

sion also eliminates many consumer products from

coverage in workplaces which may handle such materials,

but do not open the containers to use them.

The record for the original final rule strongly supported

the need for automatic transmittal of MSDSs from pro-

ducers to users through the supply chain. The cost

analyses of the rule demonstrated that a system that relies

on users requesting a copy of a MSDS will be more costly,

and less protective (48 FR 53327). However, in the revised

final rule, OSHA determined that where retail distributors

are involved in the distribution chain it was necessary to

slightly revise this position. Therefore, the revised final

rule stated ($2 FR 31882, paragraph (g)(7)):

Retail distributors which sell hazardous chemicals to

commercial customers shall provide a material safety data

sheet upon request, and shall post a sign or otherwise in-

form them that a material safety data sheet is available.

Chemical manufacturers, importers, and distributors need

not provide material safety data sheets to retail distribu-

tors which have informed them that the retail distributor

does not sell the product to commercial customers or open

the sealed container to use it in their own workplaces.

OSHA provided the following rationale for this de-

parture from the automatic provision approach found to

be necessary in the original final rule (S52 FR 31866):

Retail distributors, however, often sell to busi-

nesses and the general public and frequently have no

way of knowing who a particular purchaser is. Under

the current rule, retail distributors might have to give

material safety data sheets to each customer to ensure

that commercial customers get the information they

need under the HCS. A specific statement regarding

retail distributors is, therefore, included in paragraph

(g)(7) to address this practical problem. Those retail

distributors who sell hazardous chemicals to em-

ployers must provide a material safety data sheet

upon request, and must post a sign or otherwise in-

form the employers that an MSDS is available.

OSHA recognizes that although it is possible for an em-

ployer to incidentally purchase a hazardous chemical from

any type of retail establishment, it is not reasonable to ex-

pect every retail store that happens to carry such materials

to keep a file of MSDSs in case an employer decides to

make a random purchase at the store. We further recog

nize that such random purchases would normally be of

small amounts that would gy. -erally be used as a consumer

uses them, and thus would be exempt under the rule any-

way. However, even in those cases where they are used in

greater quantities, it appears more reasonable to place the

burden on the user in that situation to obtain the MSDS

than to have every retail establishment keep large numbers

of them on file. This provision also limits the number of

establishments to which distributors of such products have

to transmit MSDSs.

The National Retail Merchants Association (NRMA)

(Ex. 5-74) indicated that the final rule “ * * * has struck a

good balance between the obvious problem of requiring

retailers to train all employees about every product which

may appear on retailers’ shelves, and the real need for em-

ployee training for emergency spillage of packaged prod-

ucts.” They did think, however, that the definition of

“consumer product” as stated by CPSC might be con-

f using to retailers, particularly small businesses, since “re-

tailers would have to go through the process of examining

all goods sold in their stores to determine if they are or are

not consumer products.” In fact, if retailers are selling the

products they are considered to be “consumer” products —

there is no determination to be made by the retailer in this

respect, it’s a determination made by the producer in de-

veloping the appropriate label for the material based upon

its intended use.

With regard to the issue of making MSDSs available at

the retail distribution level, NRMA suggested that OSHA

define the term “commercial account” to ensure it is being

properly interpreted and applied. They further suggested

that this definition be related to selling items in large quan-

tities and below the regular retail price. “Such accounts

can be identified, and it would be less burdensome to

notify such customers that MSDSs are available upon re-

quest. In fact, many retails firms have already done this

under many state right-to-know laws.” (Ex. 5-74).

The United Brotherhood of Carpenters and Joiners of

America (UBCJA) similarly noted that with regard to

MSDSs being available from retail distributors (Ex.

2-105):

*** ([T])hose contractors who o purchase

materials from retail outlets generally buy them from

a building-supply house that sells such materials in

larger quantities, and may give them a volume dis-

count. These stores would have no problem supplying

MSDSs to customers * * *

| OSHA agrees with the NRMA that adding such a defini-

tion will clarify that many retail distributors have no need

to maintain MSDSs because they do not generally supply

hazardous chemicals to commercial customers (¢é.g.,

grocery stores, clothing stores). Therefore, we are propos-

ing a definition for the term “commercial account” based

upon NRMA’s recommended criteria, and are inviting

comment on the appropriateness of this approach. In ad-

dition, we are proposing to further modify the language in

paragraph (g)(7) to indicate that when an employer pur-

chases a consumer product from a retail establishment

which does not have commercial accounts, and that em-

ployer needs to obtain a material safety data sheet, the

retail distributor’s duty is limited to providing, upon re-

quest, the name, address, and telephone number of the

chemical manufacturer, importer, or distributor from

which a MSDS can be obtained. We believe these modi-

fications should clarify the duties of distributors of con-

sumer products through retail distribution.

In summary, OSHA is not proposing to modify the con-

sumer product exemption per se, although it is inviting

comment on certain issues. The Agency continues to main-

tain that the mode of distribution of a product (/.e.,

through retail distribution rather than wholesale) is not a

criterion that is related to employee exposure or the need

for information and therefore is not relevant to whether

consumer products should be covered by this rule. The

modifications proposed to the provisions regarding retail

distribution should clarify them to ensure the regulated

community is aware what needs to be done to comply with

the revised final rule. OSHA invites comments on these

issues as well.

OMB Determination. OMB has disapproved the infor-

mation collection requirements for any consumer products

that are exempted from the EPA requirements for com-

munity right-to-know (Ex. 4-67). OMB maintains that

such an exemption would make the OSHA and EPA right-

to-know requirements, which are closely linked, mutually

consistent. Using the same exemption in both rules avoids

the situation in which employers must separate the paper-

work for the “consumer products”into two groups: An

OSHA “consumer product” and an EPA “consumer prod-

uct.” Furthermore, OMB believes this exemption “estab-

lishes objective criteria that enable upstream and down-

stream employers to determine what is exempted and what

is included. Upstream suppliers would not be forced to

speculate as to the identity of the final user (consumer or

employer?) in determining whether the product is subject

to the HCS. The flow of MSDSs and labels would be re-

stricted to unpackaged substances or substances packaged

for industrial or commercial use, for which detailed haz-

ard information would be expected to have practical utili-

ty.” OSHA invites comments on these conclusions as well.

Drugs. The original HCS covered the manufacture and

formulation of drugs in the manufacturing sector. The

rule included a labeling exemption for such products when

they were labeled in accordance with the regulations of the

Food and Drug Administration (FDA), but all other

aspects of the program were applicable to the drug prod-

ucts as well as those chemicals used to make them. In pre-

paring the revised final rule, OSHA determined that it is

not necessary to cover such drugs in the non-manufactur-

ing sector when they are in a form that is not likely to

result in exposure to employees. Thus the rule totally ex-

empted drugs when they are in a retail establishment (/.e.,

a drug store of a pharmacy) and packaged for sale to a

consumer (paragraph (b)(60(v)). Therefore all over-the-

counter drugs were exempted from the point of packaging,

and many prescription drugs were exempted as well since

they are packaged prior to reaching the retail establish-

ment. In addition, OSHA included an exemption for

drugs in solid, final form for administration to a patient.

As mentioned previously, this was based on the Agency's

determination that the potential for exposure is minimal

for these drugs.

However, in recognition of the fact that there are

various types of workers who may be exposed to drugs in

hospitals or pharmacies (e.g., nurses, nurses’ aides, phar-

macy aides, or technicians), OSHA did not exempt those

drugs that are not solid or are not pre-packaged for sale to

consumers (a pharmacy in a hospital would be considered

to be a retail sale establishment for purposes of the exemp-

tion as written). Thus nurses required to mix anti-neo-

plastic drugs, for example, would be entitled to a material

safety data sheet and training under the revised final rule.

There was little discussion of the drug issue in the record

prior to the revised final rule (see, e.g., Ex. 2-176). How-

ever, since drugs are designed to be biologically active,

OSHA wants to ensure that employees will be properly

protected. As an example of potential problems, a recent

report in the American Industrial Hygiene Association

(Ex. 4-59) described one hospital's experience with a drug

that is generated as an aeroso! in a tent for administration

to children. Nurses, respiratory therapists, doctors, and

other employees are directly exposed when they enter the

tent to care for the patients. Information on the drug in-

dicates that such occupational exposure may result in car-

cinogenesis, fertility impairment, and fetotoxicity. In ad-

dition, however, employees who were exposed also com-

plained of experiencing acute effects such as headaches,

burning and dryness of the eyes, coughing and dryness ot

the upper respiratory tract. The hospital eventually de-

vised a protective program for exposed employees based

upon its experiences. A MSDS with recommendations for

protective measures may have helped them resolve the

situation prior to employees heing exposed.

In response to the approach taken in the revised final

rule. the -National Wholesale Druggists’ Association

(NWDA) (Ex. 5-85) recommended that OSHA recognize

package inserts approved under FDA regulations as an ac-

ceptable alternative to material safety data sheets required

under the rule. Additionally, the NWDA suggested that

the Physicians’ Desk Reference, a privately developed

reference regarding drugs, also be considered to be an

alternative to requiring MSDSs for drugs approved by

-FDA. Other commenters recommended that all prescrip-

tion drugs be exempted since they are adequately covered

by FDA labels, other available resources, and the medical

training of persons handling or supervising handling of the

drugs (Exs. 5-77 and 5-102).

Although the purpose of the Federal Food, Drug, and

Cosmetic Act administered by the FDA is to protect con-

sumers of such products and the general public (see, e.z.,

Pharmaceutical Mfrs v. FDA, 484 F. Supp. 1179, 1183

(D.Del 1980)), the product data inserts that accompany

pharmaceuticals do contain some information that is

analogous to that found on MSDSs and would provide

some protection for employees. In particular, at 21 CFR

201.100(d)(1) (as paraphrased below), FDA requires that

inserts for prescription drugs for human use must contain

the following information: Adequate information for such

use, including indications, effects, dosages, routes,

methods, and frequency and duration of administration

and any relevant warnings, hazards, contraindications,

side effects, and precautions, under which practitioners,

side effects, and precautions, under which practitioners

licensed by law to administer the drug can use the drug

safely and for the purposes for which it is intended * * *

[in] the same [ ] language and emphasis as labeling ap-

proved or permitted * * *. (Italics added). This would be

useful chemical hazard information for employees in-

volved in administering the products even though em-

ployee protection is not the primary purpose of the infor-

mation presented.

In addition to publication of such information in the

package inserts themselves, the FDA regulations also state

that (21 CFR 202.1(1)(2), as paraphrased below): [R]efer-

ences published (for example, the “Physicians’ Desk

Reference”) for use by medical practitioners, pharmacists,

Or nurses, containing drug information supplied by the

manufacturer, packer, or distributor of the drug and

which are disseminated by or on behalf of its manufac-

turer, packer, or distributor are hereby determined to be

labeling as defined [by] the Act.” (Italics added.) Accord-

ing to the Physician's Desk Reference (PDR) in its For-

ward (40th ed. 1986), “drug information” in the PDR is

“prepared by manufacturers, edited and approved by their

medical department and/or medical consultant.” PDR

publishes the information verbatim. /d.

OSHA is proposing to modify the definition of “mate-

rial safety data sheet” under the rule to indicate that a

package insert approved by FDA, or an entry in the PDR

prepared jn accordance with FDA’s requirements, be con-

sidered in compliance with the HCS requirements for a

MSDS for these products. In addition, the exemption re-

garding solid drugs is being corrected to read “e.g., tablets

or pills” rather than “i.e.” as is currently indicated in the

revised final rule (see, e.g., Exs. 5-77, 5-85, and 5-102).

The Agency is inviting comment on this issue, par-

ticularly from employees who would be affected by this

modification to ensure that they agree that this informa-

tion is adequate for their protection. The existing exemp-

tion for labeling would remain in effect, employers would

still have to have hazard communication programs where

covered, and training would have to be given to those

employees who have not previously been trained regarding

the hazards and protective measures.

Although hospitals and health care institutions have not

participated in the rulemaking to date, it appears to

OSHA that another issue of concern in these institutions

would be labeling of drugs dispensed by a pharmacist to a

nurse who gives it to the patient. It is our understanding

that these dispensed drugs may not be marked in any way,

and since the nurse doesn’t transfer the material from the

labeled container, the portable container exemption for

labeling would not apply. OSHA invites comment on sug-

gestions for dealing with this issue for non-solid drugs.

OMB Determination. OMB has disapproved “coverage

of any FDA-regulated drug” in the non-manufacturing

sector because such coverage “would result in duplicative

paperwork and is unlikely to provide additional informa-

tion of any practical utility.” (Ex. 4-67) Comment is also

invited on this alternative of totally exempting all drugs

from any coverage under the rule in terms of the non-

manufacturing sector workplaces.

Multi-employer worksite provision. When OSHA

promulgated the original final HCS, there was a require-

ment in the written hazard communication program that

employers include in the plan and implement “the methods

the employer will use to inform any contractor employers

with employees working in the employer’s workplace of

the hazardous chemicals their employees may be exposed

to while performing their work, and any suggestions for

appropriate protective measures.” 48 FR 53343, paragraph

(e)( 1 iti).

This provision was included in the rule to ensure that

contractor employers had enough information to protect

their employees when performing work on manufacturing

sites. Contractors are often used in this context to perform

such tasks as servicing and cleaning out reactor vessels,

and their employees may be exposed to significant quan-

tities of hazardous chemicals under those circumstances.

The rule did not address the opposite situation, /.e.,

where a contractor brings a hazardous chemical to the

manufacturing facility and exposes the manufacturing em-

ployer’s employees. OSHA received many inquiries from

manufacturers concerning this issue. It is apparently a per-

vasive problem, and these manufacturers wanted to be

able to use some provision in the rule to compel con-

tractors to provide such information. After a number of

informal discussions with interested parties concerning

how manufacturers might resolve this problem, OSHA in-

cluded a recommendation in its compliance directive (Ex.

4-24) that employers consider including arrangements for

an exchange of hazard information in their contracts. We

had been told that this practice was being used successfully

by a number of manufacturers.

OSHA believes that this problem of multiple employers

using hazardous chemicals on the same site becomes even

more pressing when the standard covers the non-

manufacturing sector, particularly in the construction in-

dustry. In fact, representatives of the constsuction in-

dustry have long supported requirements to ensure infor-

mation is available to them on such sites. As noted in the

preamble to the expanded rule (see 52 FR 31858-59), the

Advisory Committee on Construction Safety and Health

(ACCSH) made recommendations for signs, labels,

MSDSs, and trairfing on construction sites as early as 1980

(Ex. 4-4. Report on Occupational Health Standards for

the Construction Industry (5/16/80)). At that time the

Committee felt “that the construction employer was not in

a position to easily acquire information on the hazards

associated with the many products and materials used in

the industry, but that such information was fundamental

to the preparation of warning signs, labels, training pro-

grams, and other important job safety and health ac-

tivities.” 52 FR 31859. The HCS did not exist at the time of

the report, and the Committee thus recommended that a

solution to the problem of lack and information would be

to modify and extend the existing OSHA standard for

material safety data sheets which at the time applied only

to ship repairng, shipbuilding, and ship breaking (29 C

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