Household Products Containing Petroleum Distillates and Other Hydrocarbons; Advance Notice of Proposed Rulemaking; Request for Comments and Information

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700

Household Products Containing Petroleum Distillates and Other

Hydrocarbons; Advance Notice of Proposed Rulemaking; Request for

Comments and Information

AGENCY: Consumer Product Safety Commission.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Consumer Product Safety Commission (``CPSC'' or

``Commission'') has reason to believe that child-resistant packaging

may be needed to protect children from serious illness or injury from

products that contain either petroleum distillates or other

hydrocarbons or combinations of these ingredients. This advance notice

of proposed rulemaking (``ANPR'') initiates a rulemaking proceeding

under the Poison Prevention Packaging Act (``PPPA''). Existing PPPA

standards require child-resistant packaging for some products that

contain petroleum distillates or other hydrocarbons. The Commission

desires information on a variety of issues concerning products

containing petroleum distillates or other hydrocarbons as it considers

the possibility of requiring child-resistant packaging for additional

consumer products that contain these substances.

The Commission solicits written comments from interested persons

concerning the risks of injury or illness associated with household

products containing petroleum distillates and other hydrocarbons, the

regulatory alternatives discussed in this notice, other possible means

to address these risks, and the economic impacts of the various

regulatory alternatives.

DATES: Written comments and submissions in response to this notice must

be received by the Commission by May 12, 1997.

ADDRESSES: Comments should be mailed, preferably in five copies, to the

Office of the Secretary, Consumer Product Safety Commission,

Washington, DC 20207-0001, or delivered to the Office of the Secretary,

Consumer Product Safety Commission, Room 502, 4330 East-West Highway,

Bethesda, Maryland 20814; telephone (301) 504-0800. Comments should be

captioned ``ANPR for Petroleum Distillates.''

FOR FURTHER INFORMATION CONTACT: Suzanne Barone, Directorate for

Epidemiology and Health Sciences, Consumer Product Safety Commission,

Washington, DC 20207; telephone (301) 504-0477, ext. 1196.

SUPPLEMENTARY INFORMATION:

I. Background

1. Introduction. Petroleum distillates are a group of hydrocarbon-

based chemicals that are refined from crude oil. Petroleum distillates

include gasoline, naphtha, mineral spirits, kerosene, paraffin wax, and

tar. They are the primary ingredient in many consumer products,

including certain furniture polishes, paint solvents, adhesives, and

automotive chemicals. As explained below, the presence of such

petroleum distillates in products may contribute to the products'

toxicity.

A number of consumer products contain hydrocarbons that are not

petroleum distillates, but that can cause similar toxic effects. These

other hydrocarbons include substances such as benzene, toluene, xylene,

pine oil, turpentine, and limonene.

[[Page 8660]]

The toxicity of petroleum distillates and other hydrocarbons

affects the respiratory system. Aspiration of small amounts of these

chemicals directly into the lung, or into the lung during vomiting of

an ingested chemical, can cause chemical pneumonia, pulmonary damage,

and death. Petroleum distillates with low viscosity, such as gasoline,

kerosene, and mineral seal oil, possess the greatest potential for

aspiration.1

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\1\ Liquids with high viscosity are thick and more like syrup,

while liquids with low viscosities are thin and more watery. See

Table 1.

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As explained below, all household products that contain 10 percent

or more of petroleum distillates, or of benzene, toluene, xylene, or

turpentine, are required to have hazard warnings by regulations under

the Federal Hazardous Substances Act (``FHSA''). Some other products

that contain hydrocarbons may be required to be labeled by more general

FHSA requirements. Some, but not all, of these products are also

required to be in child-resistant packaging under PPPA regulations.

The purpose of this notice is to commence a rulemaking proceeding

to examine whether additional products containing petroleum distillates

or other hydrocarbons should be in child-resistant packaging.2

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\2\ The Commission voted 2-1 to approve publication of this

ANPR. Voting to approve were Chairman Ann Brown and Commissioner

Thomas Moore. Commissioner Mary Sheila Gall voted to develop a

Request for Information for publication in the Federal Register and

to utilize other available information sources instead of an ANPR.

Commissioner Gall also issued a statement concerning this vote. The

statement is available from the Office of the Secretary.

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II. The Possible Need for Additional Regulation

1. Poisoning information. The Commission evaluated pediatric

poisoning cases associated with product classes that are known to

include products that contain hydrocarbons, and that are not currently

required to be in child-resistant packaging. Such product areas include

adhesives, automotive chemicals, workshop chemicals, metal polishes,

spot removers, cleaning fluids, shoe polishes, and lubricants. The CPSC

staff reviewed data from various sources, including the National

Electronic Injury Surveillance System (``NEISS''), and the American

Association of Poison Control Centers' (``AAPCC'') Toxic Exposure

Surveillance System (``TESS'').

According to NEISS, between 1990 and 1994 there was an annual

estimated average of about 2,300 emergency room visits of children

under 5 years of age associated with exposure to product categories

that are not required to be in child-resistant packaging and that

include products containing petroleum distillates. About 5 percent of

these cases resulted in hospitalization.

Between October 1994 and May 1996, a CPSC contractor conducted

telephone investigations on incidents reported through NEISS that were

treated in hospital emergency rooms and involved children under 5 years

of age who had been exposed to products in the categories described

above. The telephone investigations produced 43 cases for analysis. Of

these, 18 involved petroleum distillates and 25 involved products

containing the hydrocarbon pine oil. Most of the incidents occurred in

the child's home. About 50 percent of the victims accessed the product

from its normal storage area rather than from another location.

Seventy-nine percent of the incidents involved products in the original

packaging. Most of these containers were reported to be non-child-

resistant.

In 1994, the Poison Control Centers (``PCC's) reported 5,791

exposures of children under 5 years of age that were attributed to

product categories that included only products that contain petroleum

distillates or other hydrocarbons. Of these, 1130 cases reported

symptoms, most of which were minor (exhibited some symptoms that were

minimally bothersome to the patient, i.e. the symptoms usually resolved

rapidly and usually involved skin or mucous membranes). Ninety-three of

these cases reported moderate outcomes (exhibited symptoms that were

more pronounced, more prolonged, or of more of a systemic nature than

minor symptoms). In addition, 7 cases reported major symptoms (life-

threatening or resulted in significant residual disability or

disfigurement). A number of other PCC product categories may also

include products that contain petroleum distillates or other

hydrocarbons.

The Commission is aware of 10 reported deaths since 1973 of

children under 5 following exposure to products that contained

petroleum distillates and for which child-resistant packaging is not

currently required. Six of these reports indicated that the deaths were

caused by chemical pneumonitis or aspiration.

The death and injury data discussed above suggest that the safety

of young children could be improved if additional products that contain

petroleum distillates and other hydrocarbons are required to be

packaged in child-resistant packaging.

2. Existing regulatory requirements.

a. Applicable requirements under the Federal Hazardous Substances

Act (``FHSA''). The CPSC regulates the labeling of hazardous household

products under the FHSA, 15 U.S.C. 1261-1278. Currently, FHSA

regulations require specified aspiration hazard labeling for products

containing 10 percent or more by weight of benzene, toluene, xylene, or

petroleum distillates such as kerosene, mineral seal oil, naphtha,

gasoline, mineral spirits, Stoddard solvent, and ``related''

distillates. 16 CFR 1500.14(a)(3), (b)(3). The label must bear the

signal word ``DANGER,'' the statement of hazard ``Harmful or fatal if

swallowed,'' and the statement ``Call physician immediately.'' 16 CFR

1500.14(b)(3). A similar labeling requirement applies to products

containing 10 percent or more of turpentine because of the aspiration

hazard. See 16 CFR 1500.14(b)(5).

[[Page 8661]]

In addition, section 2(p)(1) of the FHSA requires any household

product that is ``toxic'' to bear specified hazard labeling. 15 U.S.C.

1261(p)(1). Any product that presents an aspiration risk from

hydrocarbons is required to bear the labeling specified by section

2(p)(1), regardless of whether a regulation specifically applies to

that product.

b. Applicable requirements under the Poison Prevention Packaging

Act (``PPPA''). The CPSC also regulates the packaging of many household

products containing petroleum distillates or other hydrocarbons under

the PPPA, 15 U.S.C. 1471-1476. PPPA regulations require that products

be sold in child-resistant packaging.

Currently, some consumer products containing 10 percent or more by

weight of petroleum distillates, and with a viscosity less than 100

Saybolt Universal Seconds (``SUS'') at 100 deg.F, are subject to the

PPPA's child-resistant packaging standards. 3 The particular types

of petroleum distillate products that require child-resistant packaging

under the PPPA include (1) prepackaged liquid kindling and illuminating

preparations (e.g., lighter fluid) (16 CFR 1700.14(a)(7)), (2)

prepackaged solvents for paint or other similar surface-coating

materials (e.g., varnishes)(16 CFR 1700.14(a)(15)), and (3) nonemulsion

liquid furniture polish (16 CFR 1700.14(a)(2)). Child-resistant

packaging is also required for certain solvents containing 10 percent

or more of benzene, toluene, or benzene, and with a viscosity less than

100 SUS at 100 deg.F. 16 CFR 1700.14(a)(15). In addition, products

containing 10 percent or more of turpentine are required to be in

child-resistant packaging. 16 CFR 1700.14(a)(6).

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\3\ Saybolt Universal Seconds is a measure of viscosity. The

higher the SUS, the more viscous the liquid.

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c. Varying scope of the FHSA and PPPA regulations. While FHSA

labeling regulations apply generically to products that contain 10

percent or more petroleum distillates or other hydrocarbons, only

certain specified products are required to be in child-resistant

packaging under the current PPPA regulations. Therefore, a number of

household products containing petroleum distillates or other

hydrocarbons are not required to be in child-resistant packaging. For

example, cleaning solvents, automotive chemicals, shoe care products,

and floor care products may contain large amounts of various petroleum

distillates. These products are not required to be sold in child-

resistant packaging, but some of them are required to be labeled under

the FHSA. See 16 CFR 1500.14(a)(3), (b)(3).

In addition, there are some anomalies under the current PPPA

regulations concerning which products are required to be in child-

resistant packaging. For example, the existing standards require child-

resistant packaging of prepackaged kerosene for use as lamp fuel. 16

CFR 1700.14(a)(7). However, a gun cleaning solvent that contains over

90 percent kerosene does not have this requirement. Mineral spirits

used as a paint solvent require child-resistant packaging, 16 CFR

1700.14(a)(15), but such packaging is not required for spot removers

containing 75 percent mineral spirits or water repellents containing 95

percent mineral spirits. Yet, all of these consumer products are

required by the FHSA to be labeled ``Harmful or fatal if swallowed.''

16 CFR 1500.14(b)(3).

A rule to require child-resistant packaging of all household

products that contain petroleum distillates and have specified

characteristics would create a more consistent regulatory approach and

afford greater protection against poisonings.

III. Issues to be Considered During the Rulemaking

During this rulemaking, the Commission will consider the following

major issues.

1. Viscosity and percentage composition. As noted above, the PPPA's

child-resistant packaging standards currently apply to certain

specified consumer products containing 10 percent or more by weight of

petroleum distillates, and with a viscosity less than 100 SUS at 100

deg.F. Products associated with chemical pneumonia and death have had

viscosities below this level. Again, liquids with low viscosities are

more likely to be aspirated than more syrup-like liquids with high

viscosities.

The Commission's staff collected a limited number of household

products that contain petroleum distillates and measured their

viscosities. The results are listed in Table 1.

Table 1.--The Viscosities of Products Containing Petroleum Distillates

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PPPA

Regulated Viscosity (SUS @100

Product (yes or deg.F) \4\

no)

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Motor oil (10W-30)................... N 325

Heavy Mineral Oil.................... N 180

Baby Oil............................. N 70

Furniture Polish..................... Y 40

Gasoline Treatment................... N 35

Carburetor Cleaner................... N 6

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\6\ Reyes De La Rocha, S. et al. Lipoid pneumonia secondary to

baby oil aspiration: a case report and review of the literature.

Pediatric Emergency Care, 1:74, 1985.

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The Commission will consider whether a viscosity criterion should

be included in any regulation requiring child-resistant packaging for

products containing petroleum distillates or other hydrocarbons. If

such a criterion is to be included, the Commission will also consider

at what level it should be set.

2. Other hydrocarbons. The CPSC's FHSA regulations for petroleum

distillates require labeling of some products containing other

hydrocarbons, including products that contain 10 percent or more by

weight of benzene, toluene, or xylene. 16 CFR 1500.14(a)(3), (b)(3).

FHSA labeling is required because these substances have an aspiration

hazard similar to petroleum distillates.

A number of household products contain low-viscosity hydrocarbons

other than petroleum distillates. These hydrocarbons include benzene,

toluene, xylene, and terpenes. For example, terpene hydrocarbons

derived from wood or fruit are in products such as turpentine, pine

oil, and limonene. Pine oil and limonene are found in cleaning products

and spot removers, as well as disinfectants. (Products marketed as

disinfectants are not regulated by the CPSC; they are regulated as

pesticides by the Environmental Protection Agency (``EPA'').) Although

pine oil and limonene cleaning products and spot removers require FHSA

labeling, they are not currently required to be in child-resistant

packaging.

The Commission will consider whether there is a need for a special

packaging standard applicable to products containing hydrocarbons other

than petroleum distillates.

3. Aerosols. The PPPA regulation for furniture polish excludes

products in aerosol form. The rationale for excluding aerosol furniture

polishes was that aerosols would be addressed separately. 36 FR 18012

(September 8, 1971). However, there has been no further regulatory

action on aerosol furniture polishes.

The child-resistant packaging requirements for paint solvents and

kindling and illuminating preparations do not specifically exempt

aerosol products. See 16 CFR 1700.14(a)(7), (a)(15). However, the

Commission is not aware of any paint solvent or liquid kindling or

illuminating fluid sold in an aerosol form.

CPSC exposure data on aerosol products are limited.7

Inhalation of a spray lubricant has been associated with lipoid

pneumonia.8 The NEISS case investigation study, described above,

identified 4 percent of the cases as involving products in aerosol

form. However, none of the people in these aerosol cases was

hospitalized.

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\7\ Nierenberg, D.W., et al. Mineral Spirits Inhalation

Associated with Hemolysis, Pulmonary Edema, and Ventricular

Fibrillation. Arch Intern Med, 151:14337, 1991. Rodriguez de la

Vega, A. et al. Kerosene-induced Asthma. Annals of Allergy, 64:362,

1990. Glynn, K.P. and Gale, N., Exogenous Lipoid Pneumonia due to

Inhalation of Spray Lubricant, Chest, 97:1265, 1990.

\8\ Id. (Glynn, 1990).

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The cases described in the medical literature that resulted from

the inhalation of petroleum distillates from aerosols or vapors

involved prolonged or repeated exposure of adults. However, children

are subject to greater inhalation risks than are adults, for equal

exposure levels.9

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\9\ Schiller-Scotland, C.F, et al. Experimental data for total

disposition in the respiratory tract of children. Toxicol. Lett.,

72: 137, 1994.

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The Commission will consider whether aerosol products should be

included within any regulation applicable to products containing

petroleum distillates and other hydrocarbons.

4. Restricted flow. The PPPA regulation for liquid furniture polish

includes an additional requirement that no more than 2 milliliters of

product shall be obtained when the container is shaken, squeezed, or

activated once. 16 CFR 1700.14(a)(2). This requirement was included, in

part, because an open container of polish may be moved and used

multiple times throughout the house before the container is closed. 37

FR 5613 (March 17, 1972). Furniture polish is the only PPPA-regulated

substance with a restricted-flow requirement.

The Commission will consider whether other products should be

subject to a restricted flow requirement.

IV. Rulemaking Procedure

In order to issue a regulation under the PPPA, the Commission would

have to find that ``the degree or nature of the hazard to children in

the availability of (petroleum distillates and other hydrocarbons), by

reason of (their) packaging, is such that special packaging is required

to protect children from serious personal injury or serious illness

resulting from handling, using, or ingesting such substance.'' 15

U.S.C. 1472(a)(1). The Commission would also have to find that child-

resistant packaging ``is technically feasible, practicable, and

appropriate'' for products containing petroleum distillates or other

hydrocarbons. 15 U.S.C. 1472(a)(2).

According to the PPPA's legislative history, ``technically

feasible'' means that technology exists to produce packaging that

conforms to the standards.10 ``Practicable'' means that special

packaging complying with the standards can utilize modern mass

production and assembly line techniques.11 ``Appropriate'' means

that packaging complying with the standards will adequately protect the

integrity of the substance and not interfere with its intended storage

or use.12

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\10\ S. Rep. 845, 91st Cong., 2d Sess. 10 (1970).

\11\ Id.

\12\ Id.

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In addition to the required findings, the Commission is required to

consider, but not necessarily make formal findings on, (a) the

reasonableness of the standard, (b) available scientific, medical, and

engineering data concerning special packaging and concerning childhood

accidental ingestions, illness, and injury caused by household

substances, (c) the manufacturing practices of industries affected by

the PPPA, and (d) the nature and use of the household substance. 15

U.S.C. 1472(b).

A rulemaking proceeding under the PPPA is subject to the

requirements of the Administrative Procedure Act. Therefore, the

proceeding can be commenced by publication of a notice of proposed

rulemaking (``NPR''), without having previously published an ANPR.

However, in this proceeding, the Commission is publishing an ANPR in

order to obtain additional information before deciding whether to

propose a special packaging standard for products that contain

petroleum distillates or other hydrocarbons.

V. Comments Requested Concerning the Scope of a Rule

The Commission is seeking information on issues relevant to

defining the scope of any child-resistant packaging requirement for

products containing low-viscosity petroleum distillates and other

hydrocarbons. These issues include the following:

1. What, if any, viscosity and/or percentage composition should be

used as a threshold for requiring products that contain petroleum

distillates to be in child-resistant packaging?

2. Should aerosol products be included in a requirement for the

child-resistant packaging of products containing petroleum distillates

or other

[[Page 8663]]

hydrocarbons? The Commission seeks information on the possible effects

to a young child of a single acute exposure to an aerosol product

containing petroleum distillates.

3. Should PPPA regulation extend only to petroleum distillates or

should such regulation also extend to other hydrocarbons, such as

benzene, toluene, xylene, turpentine, pine oil, and limonene?

4. Should restricted flow be an additional requirement for certain

products?

VI. Additional Requests for Information

The Commission believes that information on the following issues

would also be helpful as it considers whether child-resistant packaging

should be required for the entire class of consumer products that

present an aspiration hazard because they contain petroleum distillates

or other hydrocarbons.

1. Chemical properties. Information concerning the chemical

properties of individual consumer products that contain petroleum

distillates or other hydrocarbons will be used to compare products that

do not currently require child-resistant packaging with those that do.

The Commission requests information about the form (e.g., liquid or

aerosol), formulation (including the amount of each component), and

viscosity of each product.

2. Users and use patterns. The Commission would like information

about consumer use patterns for various types of products containing

petroleum distillates or other hydrocarbons. The Commission requests

information concerning: The intended use of the product (e.g., as a

shoe waterproofer, carpet cleaner, upholstery spot remover); the

location(s) where it is used (e.g., in a garage, a kitchen, a

bathroom); the frequency of use (e.g., daily, monthly, seasonally); how

long a package of the product is retained in the home (e.g., used just

once or stored for long periods between uses); and the location(s)

where it is stored when not in use. In addition, is the product used by

consumers (more than occasionally) or is the product only used in the

home by workers, such as repair or cleaning persons?

3. Current packaging and labeling. Information about the packaging

of products that contain petroleum distillates will be used to assess

the technical feasibility, practicability, and appropriateness of

child-resistant packaging. The Commission requests information

describing current packaging, such as packaging sizes, container

material, closure material, closure design, and ASTM classification if

the package is child-resistant. Information is also requested about

whether the product has labels with warnings and instructions for use.

4. Economic information. Economic information will be used to

evaluate the impact of requiring child-resistant packaging for all

products containing petroleum distillates or other hydrocarbons. The

Commission requests information about sales of these products and about

the range of wholesale and retail prices. Further, the Commission seeks

comments on the expected cost of providing child-resistant packaging

for these products. In addition, the Commission requests information

about the potential impact that such child-resistant packaging

requirements would have on businesses, especially small businesses.

5. Incident information. Although the Commission monitors data on

ingestions by young children of products that contain petroleum

distillates and other hydrocarbons, the Commission seeks additional

information about such poisoning incidents. This information will be

used to assess the extent of injury from different product

formulations. The Commission requests information concerning the

details of scenarios resulting in poisoning incidents, and the outcome

of the incident.

Comments should be mailed, preferably in five copies, to the Office

of the Secretary, Consumer Product Safety Commission, Washington, DC

20207-0001, or delivered to the Office of the Secretary, Consumer

Product Safety Commission, Room 502, 4330 East-West Highway, Bethesda,

Maryland 20814; telephone (301) 504-0800. All comments and submissions

should be received no later than May 12, 1997.

VII. Trade Secret or Proprietary Information

Any person responding to this notice who believes that any

information submitted is trade secret or proprietary should identify

all such information at the time of submission. The Commission's staff

will receive and handle such information confidentially and in

accordance with section 6(a) of the Consumer Product Safety Act

(``CPSA''), 15 U.S.C. 2055(a). Such information will not be placed in a

public file and will not be made available to the public simply upon

request. If the Commission receives a request for disclosure of the

information or concludes that its disclosure is necessary to discharge

the Commission's responsibilities, the Commission will inform the

person who submitted the information and provide that person an

opportunity to present additional information and views concerning the

confidential nature of the information. 16 CFR 1015.18(b).

The Commission's staff will then make a determination of whether

the information is trade secret or proprietary information that cannot

be released. That determination will be made in accordance with

applicable provisions of the CPSA; the Freedom of Information Act

(``FOIA''), 5 U.S.C. 552b; 18 U.S.C 1905; the Commission's procedural

regulations at 16 CFR part 1015 governing protection and disclosure of

information under provisions of FOIA; and relevant judicial

interpretations. If any part of information that has been submitted

with a claim that the information is a trade secret or proprietary is

found to be disclosable, the person submitting the material will be

notified in writing and given at least 10 calendar days from the

receipt of the letter to seek judicial relief. 15 U.S.C. 2055(a) (5)

and (6); 16 CFR 1015.19(b).

Dated: February 21, 1997.

Sadye E. Dunn,

Secretary, Consumer Product Safety Commission.

[FR Doc. 97-4783 Filed 2-25-97; 8:45 am]

BILLING CODE 6355-01-P