CPSC OGC Advisory Opinion No. 309

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U . S . C O N S U M E R P R O O U C T S A F E T Y C O M M I S S I O N

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March ••••1987

OFFICE OF THE

GENERAL COUNSEL

Mary Martha McNamara, Esq.

Keller and Heckman

Suite 1000

1150 17th Street, N.W.

Washington, D.C. 20036

Re: Chronic Hazard Labeling for

Art Materials

Dear Ms. McNamara:

This responds to your letter of February 9, 1987, to

Charles M. Jacobson concerning chronic hazard labeling of art ma­

terials under the Federal Hazardous Substances Act (;llFHSA1l),

15

U.S.C. 59

126101276.

Your letter was forwarded to the Office of

the General Counsel because most of the questions you ask fall

within the jurisdiction of this office.

However, my response has

been reviewed by the Commission's Associate Executive Director

for Compliance and Administrative Litigation, Associate Executive

* Director for Health Sciences, and Director of the Office of Pro­

gram Management and Budget, who concur with the responses to your

questions.

.

The questions you posed, and our responses to them, are

discussed separately below.

QUESTION #l:

Does the definition of a toxic substance under the

FHSA include substances capable of causing cancer or other

chronic health hazards in human beings if exposed?

Response.

Yes.

The FHSA defines Voxic"

as "any

substance

(other than a radioactive substance) which has the capacity to

produce personal injury or illness to man through ingestion,

inhalation, or absorption through any body surface.11

15 U.S.C.

§ 1261(g)

.

A product that is, or contains, a substance that is

capable of inducing cancer in humans is certainly one that "has

the capacity to produce . . . illness to marP

if the reasonably

foreseeable use or misuse of the product will result in a sig­

nificant exposure of humans to the carcinogen.

_-.-_-.-­

through ingestion,

inhalation, or absorption through any body surface.11

15 U.S.C.

§ 1261(g)

.

A product that is, or contains, a substance that is

capable of inducing cancer in humans is certainly one that "has

the capacity to produce . . . illness to marP

if the reasonably

foreseeable use or misuse of the product will result in a sig­

nificant exposure of humans to the carcinogen.

_-.-_-.-­

Mary Martha McNamara,

Esq.

Keller and Heckman

Page 2

There is no indication in the legislative history of the

FHSA that chronic hazards are not to be included within the

definition of toxic.

In fact, Congress, in 1981, required that

where a risk of cancer, birth defects, or gene mutation would be

addressed by a regulation under section 2(q)(l)

of the FHSA, 15

U.S.C. 5

1261(q)(l), a #Chronic

Hazard Advisory Panel (VHAPV')

re­

port is a prerequisite to an advance notice of proposed

rulemaking.

15 U.S.C. $5

2077, 2080(b). This would seem to be a

clear indication of congressional intent that carcinogens, and

substances presenting other types of chronic hazards, are in­

cluded within the FHSA's

definition of toxic.

Furthermore, in the judicial review of the Commission's ban

of urea-formaldehyde foam insulation, which addressed a risk of

cancer as well as various acute hazards, the Fifth Circuit held

that the proceeding should have been conducted under the FHSA,

not the CPSA.

Gulf South Insulation v. CPSC, 701 F.2d

1137 (5th

Cir. 1983).

Therefore, we conclude that the term lVillness't

in the

FHSA's

definition of toxic includes cancer and other diseases re­

sulting from chronic exposure. As you note in your letter, this

determination is consistent with the Commission's recent action

concerning asbestos and the proposed action concerning methylene

chloride, both of which were taken under the FHSA

01 F.2d

1137 (5th

Cir. 1983).

Therefore, we conclude that the term lVillness't

in the

FHSA's

definition of toxic includes cancer and other diseases re­

sulting from chronic exposure. As you note in your letter, this

determination is consistent with the Commission's recent action

concerning asbestos and the proposed action concerning methylene

chloride, both of which were taken under the FHSA.

QUESTION #2

:

If [the answer to Question #l

is yes], must art ma­

terials containing substances [other than asbestos or methylene

chloride] that may present a carcinogenic risk to humans during

.any

reasonably foreseeable handling or use be labeled in accor­

dance with Section 2(p)(l) of the FHSA?

Answer.

Yes, at least where there is evidence that the

substance is an actual or potential human carcinogen in accor­

dance with sound scientific principles, where the exposure during

reasonably foreseeable handling or use is such that there is a

significant risk of cancer in exposed persons, and where the

product is intended for use in the household. See 15 U.S.C.

The requirements of section 2(p)(l)

§ 1261(f)

(1L

WI

and

(P).

automatically apply to hazardous substances intended for use in

the household or by children. As discussed above in the answer

to question # 1, we conclude that the FHSA's

provisions apply

fully to substances pre:senting

chronic hazards.

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ded for use in the household. See 15 U.S.C.

The requirements of section 2(p)(l)

§ 1261(f)

(1L

WI

and

(P).

automatically apply to hazardous substances intended for use in

the household or by children. As discussed above in the answer

to question # 1, we conclude that the FHSA's

provisions apply

fully to substances pre:senting

chronic hazards.

_

_

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Mary Martha McNamara,

Esq.

Keller and Heckman

Page 3

Art materials, just as other chemical substances, will have

to be considered individually to assess their potential for

. chronic hazards, in the same manner as they are reviewed for

acute hazards. After such review, the labeling for the indi­

vidual product should be tailored to fit within the framework

provided by section 2(p)(l).

QUESTION #3

:

If [section 2(p)(l) labeling is required], do the

labeling practices required by [ASTM labeling practice] D-4236

comply with Section 2(p)(l) of the FHSA?

Answer.

Yes.

We see nothing in ASTM labeling practice

D­

4236 that would conflict with the requirements of section

2(P) (I)?

and compliance with D-4236 would fulfill the require­

ments of section 2(p)(I). Some provisions of D-4236 may go be­

yond that which could be required under section 2(p)(l), such as

the listing of all sensitizing components required by section 5.5

of the practice. A product's labeling would also have to address

any of the other hazards specified in the FHSA, such as

flammability or corrosiveness, that are presented, and the label­

ing should meet the placement and conspicuousness requirements

specified in 16 C.F.R. !$

1500.121.

QUESTION #4

:

If [the answer to question 3 is yes], do the label­

ing requirements for chronic hazards in art materials under Sec­

tion 2(p)(l) of the FHSA preempt any state requiremen,ts.

Answer.

Yes, at least where the state requirement is for

cautionary labeling and addresses the same risk as the section

2(p) requirement

and conspicuousness requirements

specified in 16 C.F.R. !$

1500.121.

QUESTION #4

:

If [the answer to question 3 is yes], do the label­

ing requirements for chronic hazards in art materials under Sec­

tion 2(p)(l) of the FHSA preempt any state requiremen,ts.

Answer.

Yes, at least where the state requirement is for

cautionary labeling and addresses the same risk as the section

2(p) requirement.

Under FHSA section 18(b)(l)(A):

[I]f

a hazardous substance or its labeling is

subject to a cautionary labeling requirement

under section 2(p) . . .

no State or po­

litical subdivision of a State may establish

or continue in effect a cautionary labeling

requirement . . . designed to protect against

the same risk

of illness or injury unless

such [state] cautionary labeling requirement

is identical to the labeling requirement un­

der section 2(p) . . .

15 U.S.C. 0

1261n.

Mary Martha McNamara,

Esq.

Keller and Heckman

1

Page 4

While the opinions given above are the latest interpreta­

tion of the law by this office, they could be changed subse­

quently by the CommissLon.

We hope this information is helpful to you. We greatly ap­

preciate the voluntary efforts of the members of the Coalition in

developing the ASTM labeling practice. We trust the opinions

given above are consistent with our mutual desire to have a

strong and effective voluntary standard for art materials.

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February 9, 1987

202/956-563L:

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Mr. Charles M. JacobsonJ;

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Division of Regulatory Management

Directorate for Compliance and

Administrative Litigation

Consumer Product Safety Commission

Washington, DC 20207

Re:

Chronic Hazard Labeling for Art Materiak

Dear Mr. Jacobson:

The Consumer Product Safety Commission (Commission)

recently took two actions under the Federal Hazardous Substances

Act (FHSA)

against chemicals that pose a chronic hazard.

Specifically, the Commission proposed a rule declaring methylene

chloride in household products to be a hazardous substance

"due to a risk of cancer from inhalation of methylene chloride

vapor."

51 FR 29778 (August 20, 1986).

Then the Commission

issued a Notice of Enforcement Policy declaring household

products containing intentionally added asbestos to ibe

hazardous

substances requiring proper labels under the FHSA.

51 FR 33910

(September 24, 1986).

Both of these actions impact, inter

alia, artists' materials and raise questions among the members

of the Art Supplies Labeling Coalition (Coalition), who requested

that we obtain a clarification from the Commission o:n several

issues affecting them

containing intentionally added asbestos to ibe

hazardous

substances requiring proper labels under the FHSA.

51 FR 33910

(September 24, 1986).

Both of these actions impact, inter

alia, artists' materials and raise questions among the members

of the Art Supplies Labeling Coalition (Coalition), who requested

that we obtain a clarification from the Commission o:n several

issues affecting them.

As you know, the Coalition is composed of associations

representing manufacturers, distributors, retailers, and

users of art materials.

It was formed to develop a voluntary

standard for the labeling of chronic hazards in art supplies

under the auspices of the American Society for Testing Materials

(ASTM).

The voluntary standard, D-4236, has been in place

for several years now and manufacturers have begun tlo

label

their art material products in conformance with D-4236.

At the time the standard was developed, it was thought that

the automatic labeling requirements of the FHSA did not apply

to chronic hazards in household products.

However, these

two recent actions of the Commission appear to dispel that

notion.

i

-

K E L L E R A N D HECKMBN

Mr. Charles M. Jacobson

February 9, 1987

Page Two

Therefore, we would appreciate clarifications for

several related issues:

(1)

Does the definition of a toxic substance

under the FHSA include substances

capable of causing cancer or other

chronic health hazards in human beings

if exposed?

(2) If so, must art materials containing

substances,11

that may present a carcino­

genic or other chronic hazard health

risk to humans during any reasonably,

foreseeable handling or use be labeled

in accordance with Section 2(p)(l)

of the FHSA?

(3)

If so, do the labeling practice&

required by D-4236 comply with Section

2(p)(l)

of the FHSA?

(4)

If so, do the labeling requirements

for chronic hazards in art materials

under Section 2(p)

es,11

that may present a carcino­

genic or other chronic hazard health

risk to humans during any reasonably,

foreseeable handling or use be labeled

in accordance with Section 2(p)(l)

of the FHSA?

(3)

If so, do the labeling practice&

required by D-4236 comply with Section

2(p)(l)

of the FHSA?

(4)

If so, do the labeling requirements

for chronic hazards in art materials

under Section 2(p)

(1)

of the FHSA

preempt any state requirements?

The Coalition is

anxious to preserve the voluntary

standard it worked so diligently to develop, but is ever

aware of its obligations under the FHSA.

In this instance,

we hope that the voluntary standard will emulate the FHSA.

Your guidance on the Commission's present interpretation

of the FHSA labeling requirements for chronic hazards in

art materials will be greatly appreciated.

.

With best wishes,

Sincerely,

Mary Martha McNamara

Enclosure

cc:

Deborah Fanning

l/We

refer to substances other than asbestos and methylene

chloride.

L/Attached is Appendix A.

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APPENDIX A

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