[Federal Register Volume 62, Number 38 (Wednesday, February 26, 1997)]
[Proposed Rules]
[Pages 8659-8663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4783]
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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 <32 \5\
Degreaser............................ N <32 \4\
Lighter Fluid....................... Y <32 \4\
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\4\ The staff measured the viscosity at 100 deg.F using a Brookfield
viscometer calibrated in centistokes (cs). The value was converted to
SUS using Table 1 of ASTM D 2161-93, Standard Practice for Conversion
of Kinematic Viscosity to Saybolt Universal Viscosity or to Saybolt
Furol Viscosity.
\5\ There are no equivalent viscosities measured in SUS for viscosities
less than 1.8 cs. The viscosity of 1.83 cs is equivalent to 32 SUS.
The staff's initial laboratory analysis, summarized in Table 1,
shows that lighter weight oils, including some baby oils, would be
included in a regulation that required child-resistant packaging of all
products containing at least 10 percent petroleum distillates with a
viscosity less than 100 SUS at 100 deg.F.
[[Page 8662]]
There are reported cases of lipoid pneumonia and deaths from aspiration
of lubricants, including baby oil, a spray lubricant, chain saw oil,
and trumpet valve oil.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