[Federal Register Volume 65, Number 1 (Monday, January 3, 2000)]
[Proposed Rules]
[Pages 93-104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33770]


=======================================================================
-----------------------------------------------------------------------

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


Household Products Containing Hydrocarbons

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

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 low-viscosity hydrocarbons. This notice of 
proposed rulemaking (``NPR'') proposes a rule under the Poison 
Prevention Packaging Act (``PPPA'') that would require child-resistant 
packaging for many products that contain low-viscosity hydrocarbons. 
The Commission solicits written comments from interested persons.

DATES: The Commission must receive any comments in response to this 
notice by March 20, 2000.

ADDRESSES: Comments should be mailed, preferably in five copies, to the 
Office of the Secretary, Consumer Product Safety Commission, 
Washington, D.C. 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 
also may be filed by telefacsimile to (301)504-0127 or by email to 
[email protected]. Comments should be captioned ``NPR for 
Hydrocarbons.''

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:

A. Background

    The Poison Prevention Packaging Act (``PPPA''), 15 U.S.C. 1471-
1476, authorizes the U.S. Consumer Product Safety Commission (``CPSC'') 
to require child-resistant packaging of hazardous household substances 
in appropriate cases. This notice proposes to require child-resistant 
packaging for certain low-viscosity hydrocarbon products. 1
---------------------------------------------------------------------------

    \1\ Statements by the Commissioners concerning this action are 
available from the Office of the Secretary.
---------------------------------------------------------------------------

    Direct aspiration into the lung, or aspiration during vomiting, of 
small amounts of petroleum distillates and other similar hydrocarbon 
solvents can result in chemical pneumonia, pulmonary damage, and death. 
Except in specific instances, the current regulations do not require 
that these solvents be in child-resistant packaging. However, these 
chemicals are the primary ingredients in many different consumer 
products to which children have access.
    The viscosity of a hydrocarbon-containing product contributes to 
its potential toxicity. Viscosity is the measurement of the ability of 
liquid to flow. Liquids with high viscosities are thick or ``syrupy,'' 
and liquids with low viscosities are more ``watery.'' Products with low 
viscosity pose a greater risk of aspiration into the lungs.
    Under regulations issued under the Federal Hazardous Substances Act 
(``FHSA''), the CPSC regulates the labeling of hazardous household 
substances containing 10 percent or more by weight petroleum 
distillates because these products may cause injury or illness if 
ingested. 16 CFR 1500.14. The PPPA regulations also require child-
resistant packaging for some household products containing

[[Page 94]]

petroleum distillates. 16 CFR 1700.14. Under these PPPA regulations, 
certain consumer products containing 10 percent or more by weight of 
petroleum distillates, and having viscosities less than 100 Saybolt 
Universal Seconds (SUS) at 100 deg.F, are subject to child-resistant 
packaging standards. These PPPA-regulated products include prepackaged 
liquid kindling and illuminating preparations (e.g., lighter fluid) (16 
CFR 1700.14(a)(7)), prepackaged solvents for paint or other similar 
surface-coating materials (e.g., paint thinners) (16 CFR 
1700.14(a)(15)), and nonemulsion liquid furniture polish (16 CFR 
1700.14(a)(2)).
    Because hydrocarbons are not now regulated under the PPPA as a 
chemical class, many hydrocarbon-based consumer products are not 
required to be in child-resistant packaging. For example, cleaning 
solvents, automotive chemicals, shoe-care products, and cosmetics may 
contain large amounts of various hydrocarbons and are not required to 
be in child-resistant packaging. The existing child-resistant packaging 
standard requires child-resistant packaging of prepackaged kerosene for 
use as lamp fuel; however, a gun cleaning solvent that contains over 90 
percent kerosene does not have to meet this requirement. Mineral 
spirits used as a paint solvent require child-resistant packaging, but 
spot removers containing 75 percent mineral spirits, and water 
repellents containing 95 percent mineral spirits, do not.
    On February 26, 1997, the CPSC issued an advance notice of proposed 
rulemaking (``ANPR'') to request comments and information about whether 
to require child-resistant packaging of hazardous household products 
that contain petroleum distillates and other hydrocarbons. 62 FR 8659. 
In addition to protecting children from serious injury, a rule 
requiring all hazardous products containing hydrocarbons to be subject 
to a child-resistant packaging standard would create a more consistent 
and comprehensive regulatory approach to child-resistant packaging for 
these products.
    In the ANPR, the Commission solicited information on four specific 
issues: (1) The appropriate viscosity and/or percentage composition to 
be used as a threshold for requiring products that contain petroleum 
distillates to be in child-resistant packaging, (2) the inclusion of 
aerosol products in a requirement for the child-resistant packaging of 
products containing petroleum distillates or other hydrocarbons, (3) 
the scope of a rule to extend beyond petroleum distillates to include 
other hydrocarbons, such as benzene, toluene, xylene, pine oil, and 
limonene, and (4) the inclusion of restricted flow as an additional 
requirement for certain products, which would restrict the amount of 
product dispensed from an opened package during each attempt.
    The Commission also solicited information on products that may be 
affected by such a rule, including chemical properties, users and use 
patterns, current packaging and labeling, economic information, and 
incident reports. The Commission extended the comment period until 
September 1, 1997, at the request of the Chemical Specialty 
Manufacturers Association (``CSMA'') and the Cosmetic, Toiletry, and 
Fragrance Association (``CTFA''). 62 FR 22897 (April 28, 1997); 62 FR 
38948 (July 21, 1997).
    Staff also sent copies of the ANPR to 9 trade associations 
(representing over 1300 small and large companies) and to over 200 
individual manufacturers of household products that may contain 
hydrocarbons.

B. The Scope of the Proposed Regulation

    After reviewing the comments submitted in response to the ANPR, the 
Commission decided to propose a broad PPPA rule for household products 
that contain chemicals capable of causing chemical pneumonia and death 
following aspiration. The remainder of this Section B describes the 
scope and form of the proposed rule. Additional discussion of the 
rationale for these decisions is in later sections of this notice.
    The proposed rule applies to prepackaged nonemulsion-type liquid 
household chemical products, including drugs and cosmetics, that 
contain 10 percent or more hydrocarbons by weight and have a viscosity 
of less than 100 SUS at 100 deg.F. Hydrocarbons are defined as 
compounds that consist solely of carbon and hydrogen. For products that 
contain multiple hydrocarbons, the total percentage of hydrocarbon in 
the product is calculated by adding the percentage by weight of the 
individual hydrocarbon components.
    The definition of what is a ``household substance'' that can be 
regulated under the PPPA includes both a ``hazardous substance'' as 
defined in the FHSA and a ``food, drug, or cosmetic'' as those terms 
are defined in the Federal Food, Drug, and Cosmetic Act 
(``FDCA'').2 The enforcement of the PPPA with respect to 
hazardous substances relies on the misbranding and prohibited acts 
sections of the FHSA. The enforcement of child-resistant packaging 
requirements applicable to foods, drugs, or cosmetics relies on 
comparable provisions of the FDCA. Therefore, the Commission is issuing 
two separate rules, one for hazardous substances and one for drugs and 
cosmetics, to more closely associate a particular rule with the 
applicable enforcement mechanism. (Foods also are not covered under the 
proposed rule, because there are no data indicating a need for child-
resistant packaging of food products.)
---------------------------------------------------------------------------

    \2\  A third category of products is included in the PPPA's 
definition of ``household substance.'' This is ``a substance 
intended for use as fuel when stored in a portable container and 
used in the heating, cooking, or refrigeration system of a house.'' 
15 U.S.C. 1471(2)(C). These fuels are not subject to the proposed 
rule because there is no reason to believe there is a need for 
child-resistant packaging of such products. (The Commission believes 
that products such as cans of kerosene sold to consumers likely are 
not ``fuel * * * used in the heating * * * system of a house,'' even 
though some kerosene is used in portable heaters that may be used to 
heat a house. However, the Commission concludes that such products 
are ``hazardous substance[s]'' as defined in the FHSA.)
---------------------------------------------------------------------------

    On November 19, 1998, the staff met with interested trade 
associations to discuss the scope of the potential rule. The emphasis 
of the meeting was to obtain information on various products or 
packaging types that should be included or excluded from the rule 
(Meeting log, December 3, 1998). Several trade associations submitted 
comments in response to the meeting. After considering these and the 
other comments, the Commission decided to exclude from the proposed 
rule products that do not present the risk of aspiration because of the 
way the product is dispensed. For example, aerosol products (i.e., 
pressurized spray containers) that expel the product in a mist do not 
pose the risk of aspiration. The Commission also excluded products 
packaged in mechanical pumps and trigger sprayers that expel product in 
a mist, provided that the spray mechanism is either permanently 
attached to the bottle or has a child-resistant attachment. This makes 
the misted pump or trigger sprayer package equivalent to an aerosol 
can. If the aerosol can, mechanical pump, or trigger sprayer expels 
product in a stream (either solely or as an option), the spray 
mechanism and the means for affixing it to the reservoir container must 
be child-resistant. Aerosols and permanently affixed pumps or triggers 
may use a child-resistant overcap in lieu of a child-resistant 
actuating mechanism. Also, aerosol products that form a stream only 
when an extension

[[Page 95]]

tube is inserted into the nozzle would be excluded from the packaging 
requirements if, without the tube, the product is expelled as a mist.
    The FHSA regulation partially exempts small packages, minor 
hazards, and special circumstances from the FHSA's labeling 
requirements. 16 CFR 1500.83(a). Writing markers and ballpoint pens are 
exempt from full cautionary labeling requirements relating to toxicity 
if they meet certain specifications listed in the regulations. These 
products are also excluded from the proposed child-resistant packaging 
requirements due to the difficulty a child would have obtaining a toxic 
amount of fluid from these types of products. For the same reason, 
products that are packaged so their contents are not free-flowing, such 
as some battery terminal cleaners, paint markers, and make-up removal 
pads, are excluded from the proposed child-resistant packaging 
requirements.
    The following section describes some of the products that may be 
subject to a child-resistant packaging standard if the proposed rule is 
ultimately issued.

C. Products That May Be Subject to the Proposed Rule

    The proposed standard includes all household products as defined in 
the PPPA, unless exempted, that contain 10 percent or more hydrocarbons 
by weight and have a viscosity of less than 100 SUS at 100 deg. F. This 
would impact many different classes of products that currently do not 
require child-resistant packaging. However, not all of the products 
within each category would require child-resistant packaging under the 
proposed rule, because many of those products do not meet the specified 
composition and viscosity criteria.
    The staff identified several different automotive products that 
would require child-resistant packaging under the proposed rule. These 
products include carburetor cleaners, fuel injection cleaners, and some 
gasoline additives. Many of these products are intended for single use, 
and some are already in child-resistant packaging. Automotive 
lubricants, including motor oil and spray lubricants, for the most part 
will not be included in a proposed rule because motor oils have high 
viscosities and aerosols that expel the product as a mist are excluded 
from the proposed rule.
    Other household chemicals subject to the proposed rule include spot 
removers and water repellents. Several of the spot removers that the 
staff identified were already in child-resistant packaging. However, 
the water repellents, especially those made for shoe care, are not. 
Cleaning products, including some floor and metal cleaners, would also 
be impacted by the proposed rule. Some miscellaneous sports-related 
products, including gun cleaners and archery arrow feather water 
repellents, contain hydrocarbons but were not in child-resistant 
packaging. Most writing instruments, including all markers and pens, 
are exempt from the proposed rule because they do not expel free-
flowing hydrocarbons.
    The current PPPA regulation requires child-resistant packaging of 
solvents for paint and other surface coatings, but child-resistant 
packaging of paint and varnishes themselves is not currently required. 
Most paints would not be included in the proposed rule because they 
contain insufficient hydrocarbons or are too viscous. However, some 
sealers, non-water-based varnishes, and stains may be covered. As 
discussed above, aerosol spray paints are not included in the proposed 
rule.
    There are several categories of cosmetics that would be included in 
the proposed rule. In general, creams and lotions are not subject to 
the rule because they are either too viscous or are emulsions. Most 
baby oils, excluding lotions and gels, would be included in the 
proposal. The inclusion of other cosmetic products depends on their 
viscosities. Because of their composition and viscosities, some bath 
and suntan oils would be subject to the proposed rule, while others 
would not. Make-up removers and nail/cuticle conditioners may or may 
not require child-resistant packaging depending on hydrocarbon content, 
viscosity, and product form. Wipes and saturated pads are exempt.
    These are the major product groups that have been identified. There 
may be other individual products that would require child-resistant 
packaging that have not been identified either by the staff or the 
comments on the ANPR.
    The following section addresses the comments on the ANPR and 
further discusses the rationale for the scope of this rule.

D. The Commission's Response to Comments on the ANPR

    The ANPR was sent to 221 trade associations and businesses believed 
to be involved with petroleum-distillate-containing products. Thirty 
individuals and groups submitted comments. Four commenters (comments 
numbered CP97-2-3, -11, -12, -18) supported the rule. Most of the other 
comments focused on which products should or should not be subject to 
such a rule.
    1. The scope of the rule.
    (a) Aerosols. Comment: Should a child-resistant packaging standard 
for low-viscosity petroleum distillates include aerosol products?
    Response: There is insufficient evidence to demonstrate that there 
is a serious aspiration hazard from self-pressurized aerosols or spray 
mists that contain petroleum distillates. The commenters cited the 
results of animal studies conducted in the 1960's. The staff is not 
aware of new animal or human experience data that would change the 
conclusions that misted aerosols sprayed into the mouth do not pool in 
the mouth to result in aspiration. Accordingly, hydrocarbon-containing 
products in pressurized containers, that are expelled as a mist, are 
exempt from the proposed child-resistant packaging requirements.
    Under the FHSA, special labeling related to toxicity is required 
for products containing 10 percent or more by weight of toluene, 
xylene, and petroleum distillates that may be aspirated into the lungs 
and result in chemical pneumonitis and death. For aerosol products, 
this special labeling under 16 CFR 1500.14(b)(3) related to the 
ingestion of hydrocarbon-containing products is required only when the 
contents are expelled as a stream. The industry requested that all 
hydrocarbon-containing aerosols be exempted from the child-resistant 
packaging requirements. However, a large volume delivered directly into 
the mouth could result in aspiration. Therefore, self-pressurized 
packages of hydrocarbon-containing products that can be dispensed in a 
coherent stream would be subject to the proposed child-resistant 
packaging requirements. Aerosol products that form a stream only when 
an extension tube is inserted into the nozzle would be excluded from 
the packaging requirements if, without the tube, the product is 
expelled as a mist. The CPSC laboratory staff determined that these 
products can be expelled through the extension tube at a rate of 1-2 
ml/sec (Cobb, March 8, 1999). However, it is unlikely that a 2-or 3-
year-old child would obtain a sufficient amount of fluid via this route 
to cause an aspiration hazard.
    (b) Viscosity. Issue: What is the appropriate viscosity for 
requiring child-resistant packaging of products that contain 
hydrocarbons?
    Response: After reviewing the submitted data and comments 
pertaining to viscosity, the Commission determined that the viscosity 
level where child-resistant packaging is not needed to protect children 
should remain at or above 100 SUS at 100 deg. F. This is the viscosity 
below which the

[[Page 96]]

FHSA regulations require precautionary labeling for ingestion of 
petroleum distillate-containing products and the PPPA regulations 
require child-resistant packaging of three product categories 
(furniture polish, paint solvents, and kindling and illuminating 
products).
    Commenters and the medical literature agree that lower viscosities 
are associated with a greater risk of aspiration; however, there is no 
agreement about defining a ``safe'' upper level for viscosity. One 
published review article suggests that products with viscosities of 60 
SUS or greater have low aspiration potential (Litovitz and Greene, 
1988). Another recent review article recommends that only products with 
viscosities of less than 73.4 SUS require labels warning about the 
hazard of aspiration (Craan, 1996).
    A draft revision to the Canadian Consumer Chemicals and Containers 
Regulations (CCCR) adopts 73.4 SUS and below for child-resistant 
packaging and cautionary labeling requirements. The current Canadian 
labeling and packaging requirements (CP97-2-23) use 70 SUS as the upper 
level.
    There are concerns about this level because aspirations and 
resulting serious injury or death from pneumonitis and lipoid pneumonia 
have been documented with mineral oil-based products such as baby oil 
(Reyes De La Rocha et al, 1985, Perrot et al, 1992, IDI 97030HCC9033). 
These products have viscosities in the 60-75 SUS range.
    Another comment asserted that the appropriate upper level based on 
the animal studies by Gerarde in the 1960's was 81 SUS (Klein, July 16, 
1998, Gerarde, 1963). However, this level is too low, since it is at or 
close to the viscosity associated with aspiration of products that 
resulted in deaths and serious injuries. Therefore, the proposal 
includes products with viscosity levels less than 100 SUS at 100 deg.F 
within the child-resistant packaging standard.
    This would expand the current child-resistant packaging 
requirements from those limited to furniture polish, kindling and 
illuminating fluids, and paint solvents to include other product 
categories with similar ingredients and viscosities.
    (c) Hydrocarbons other than petroleum distillates. Issue. Should a 
child-resistant packaging requirement include products that contain 
hydrocarbons other than petroleum distillates?
    Response: Comments for and against including hydrocarbons other 
than petroleum distillates were received. Some commenters wanted to 
limit the rule to petroleum distillates. Other commenters suggested 
that compounds with the same risk of aspiration should be regulated 
regardless of their source. The Commission's decision falls between 
these two suggestions. The proposed rule includes products with 
solvents containing only hydrogen and carbon, commonly known as 
``hydrocarbons.'' The term ``petroleum distillate'' is archaic and 
refers to mixtures of hydrocarbons that are distilled from petroleum. 
There has been confusion about ``petroleum distillates,'' especially 
regarding the aromatic hydrocarbons benzene, xylene, and toluene. The 
aromatics are components of some of the distillation fractions. 
However, the aromatics are not universally considered to be petroleum 
distillates because the toxicity of aromatics differs from the 
aliphatic chemicals. The Canadian standards currently do not include 
the aromatic hydrocarbons in their definition of petroleum distillates 
for cautionary labeling and child-resistant packaging (CP97-2-23).
    In order for the proposed rule to be definite and comprehensive, 
the Commission proposes to not use the term ``petroleum distillate'' to 
define the scope of the rule. Instead the rule applies to those 
chemicals that contain only hydrogen and carbon. This will minimize 
confusion by making it clear that the aromatic hydrocarbons are 
intended to be included in a child-resistant packaging requirement. 
However, this does not change the FHSA's specific labeling requirements 
for the aromatic hydrocarbons. The Canadians have taken a similar 
approach. A draft revision to the Canadian standard eliminates the term 
``petroleum distillate'' and lists chemical structures and classes to 
clarify what is included in the regulations.
    Using the term hydrocarbon clarifies that the rulemaking will not 
be limited to petroleum-derived chemicals. It also eliminates one 
commenter's concern about confusion over whether the chemical limonene 
includes several different compounds. The recommended rule does not 
name individual compounds. Whether a product would require child-
resistant packaging would depend on the total amount of hydrocarbon (by 
weight) and the product's viscosity.
    The draft standard in Canada extends the requirements for labeling 
and packaging of aspiration hazards to include certain alcohols and 
ketones. The CPSC did not expand this rulemaking to include non-
hydrocarbon chemicals, such as terpene alcohols, ketones, or alcohols, 
because of the diverse chemistry, toxicity, and uses of these 
chemicals. These non-hydrocarbon chemical classes should be evaluated 
separately for the need for child-resistant packaging.
    (2) Restricted flow.
    Issue: Should restricted flow be an additional requirement for 
certain products?
    Response: Restricted flow is defined in 16 CFR 1700.15(d) as ``* * 
* the flow of liquid is so restricted that not more than 2 milliliters 
of the contents can be obtained when the inverted, opened container is 
shaken or squeezed once or when the container is otherwise activated 
once.'' Restricted flow is required in addition to child-resistant 
packaging for liquid furniture polish because many ingestions occurred 
while the product was in use and the top was already off. 16 CFR 
1700.14(a)(2).
    Restricted flow alone is not adequate to protect children, however. 
It does not prevent the child from directly accessing the product if 
the package is not child-resistant. Although restricted flow limits the 
amount of product a child can obtain each time the child attempts to 
ingest the product from the container, it does not limit the number of 
attempts the child may make.
    None of the commenters identified a product class as needing 
restricted flow in addition to child-resistant packaging. Several 
commenters mentioned that restricted flow would impede the use of 
products where greater volumes are necessary for use. These commenters 
did not identify specific products.
    A commenter requested that restricted flow be an alternative to 
child-resistant packaging for cosmetic products such as baby, body, and 
bath oils. The commenter stated that older adults might have difficulty 
opening the child-resistant packaging with hands wet from the bath or 
shower. The commenter stated that many of these products already had 
restricted flow.
    The CPSC staff examined some cosmetic products with restricted 
orifices. None of these products met the PPPA's regulatory definition 
of restricted flow. The PPPA test procedures use adults aged 50 to 70 
to determine adult-use-effectiveness for most packaging. This has led 
to the development of packaging systems that are easier for all adults 
to use properly (including resecuring the cap).
    Furthermore, the rationale for restricted flow with furniture 
polish is that children would have access to the bottle during its use, 
in addition to when it was in storage. Therefore, the restricted-flow 
requirement is in addition to, not in lieu of, child-resistant 
packaging.

[[Page 97]]

    The Commission has not identified any specific product or product 
category where restricted flow would add additional protection to 
children. Therefore, the Commission is not requiring restricted flow 
for additional product categories. The requirement for restricted flow 
of liquid furniture polish currently in the PPPA regulations will 
remain.
    (3) Injury data.
    Comment: Several commenters (CP97-2-6, -15, -19-21) stated that the 
number of incidents and deaths were low and that child-resistant 
packaging was not justified.
    Response: The CPSC believes that child-resistant packaging 
regulations should not be based solely on the number of incidents known 
to have occurred in the past. Before issuing a regulation under the 
PPPA, the Commission must find that ``the degree or nature of the 
hazard to children in the availability of hydrocarbons, by reason of 
its 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 ANPR presented ingestion data from various sources, including 
the CPSC's National Electronic Injury Surveillance System (``NEISS'') 
and the Toxic Exposure Surveillance System (``TESS'') maintained by the 
American Association of Poison Control Centers (``AAPCC''). The staff 
collected additional information on the NEISS cases where possible. The 
data collection was limited to product categories that may contain 
petroleum distillates and that are not currently required to be in 
child-resistant packaging. From these data, it can be shown that 
children do gain access to the categories of products that include some 
products that contain hydrocarbons.
    The potential for aspiration and serious injury from these 
chemicals is well documented. Each time a child gains access to one of 
these products that is not in child-resistant packaging, there is the 
potential for ingestion, aspiration, pneumonitis, and death. Therefore, 
the Commission is proposing to require child-resistant packaging to 
protect children from accessing these products.
    (4) Packaging.
    (a) Exempt aerosols. Comment: One commenter (CP97-2-20 and 20a) 
stated that there are no currently available child-resistant/senior-
friendly overcaps for aerosols. The commenter requested that the rule 
be clarified to say that aerosols are exempt from the senior-friendly 
requirements.
    Response: The PPPA regulations exempt from the senior-friendly 
portion of the PPPA's requirements products that must be in aerosol 
form and products that require metal containers with reclosable metal 
closures. 16 CFR 1700.15(b)(2)(ii)(A). It is unnecessary to repeat this 
exemption specifically in a rule for hydrocarbon-containing products. 
However, the staff is aware of several child-resistant overcap designs 
that meet the senior-friendly requirements. The Commission will 
consider revisiting this issue in the future, but it is outside the 
scope of this rulemaking.
    (b) Exempt single-use products with heat seals. Comment: Several 
commenters (CP97-2-20a and 7) requested that single use products with 
heat seals be exempted from the requirements.
    Response: Any regulated product that is intended and likely to be 
fully used in a single application must meet the child-resistance and 
adult-use-effectiveness specifications for only the first opening, 
since a toxic amount of the product will not remain after the product 
is opened and used. The manufacturer may use any packaging option that 
meets the PPPA requirements for the first opening. The CPSC has no data 
from tests of packages with thermal foil seals.
    (5) Miscellaneous.
    (a) Education campaign. Comment: The CSMA and several of its 
members (CP97-2-20, -15) requested that CPSC work with them and others 
on an education campaign to encourage consumers to read product labels 
and follow the directions and cautions. They request this because 
several of the incidents occurred while the product was not in its 
original container and, therefore, child-resistant packaging would not 
have prevented the incidents.
    Response: The Commission agrees that education has value when used 
to communicate a safety message. Consumers need to be reminded to use 
child-resistant packaging properly. However, education does not replace 
the need for child-resistant packaging. Child-resistant packaging 
prevents ingestions and saves lives directly by creating a barrier 
between the child and the substance.
    (b) Parental responsibility. Comment: One commenter (CP97-2-4) 
indicated that the issue was one of parental responsibility and that 
regulation was unnecessary.
    Response: The issue of parental responsibility and child poisoning 
is not new. The Congressional Committee on Commerce dealt with this 
issue while drafting the Poison Prevention Packaging Act of 1970. The 
Committee report states, `` * * * parental negligence is not the 
primary cause of poisonings. There are too many potentially hazardous 
products in the modern home to hope that all of them can be kept out of 
the reach of children.'' Child-resistant packaging creates a barrier 
between the child and the hazardous product when adult vigilance is 
insufficient. Therefore, the Commission proposes a rule to protect from 
ingesting products having the same potential aspiration hazard as other 
products that currently are required to have child-resistant packaging.
    (c) Labeling. Comment: Comments (CP97-2-6, -25) were received 
stating that the labeling required under the FHSA was adequate to 
protect against the hazard and that child-resistant packaging was 
therefore unnecessary.
    Response: Labels make important information available to the 
consumer; however, poisoning data demonstrate the inadequacy of 
labeling alone as an injury prevention strategy. The PPPA itself 
recognizes that FHSA labeling is not necessarily adequate to protect 
children by giving the Commission the ability to require child-
resistant packaging for products that are toxic and thus already have 
to bear precautionary labeling including ``Keep out of the reach of 
children.'' Human experience shows that it is unrealistic to expect 
labels to provide the same degree of protection as child-resistant 
packaging.
    (d) Garage storage. Comment: A comment (CP97-2-1) stated that 
automotive products should not be included because they are stored in 
the garage and children do not have access to them.
    (e) Response: The NEISS and TESS data included in the ANPR 
demonstrate that children do gain access to automotive products. These 
products should be in child-resistant packaging if they contain 
hydrocarbons and can be aspirated. Several companies voluntarily 
package their hydrocarbon-containing automotive products in child-
resistant packaging.
    (f) Graffiti and ``huffing.'' Comment: One commenter (CP97-2-25) 
stated that child-resistant packaging of aerosol paints would not 
prevent vandalism or inhalant abuse (huffing).
    Response: The Commission agrees with the commenter. The purpose of 
this rulemaking is to prevent children under 5 years of age from 
ingesting products that result in serious injury. To the extent that 
graffiti and huffing are done by older children, this

[[Page 98]]

recommended rule would have little, if any, effect on these behaviors. 
To the extent the comment argues that aerosols should not be subject to 
the rule, most (those that expel the substance as a mist) are not.
    (g) Increased risk of injury to children. Comment: The Cosmetics, 
Toiletries, and Fragrance Association (CP97-2-28) commented that 
requiring child-resistant packaging on baby oil could result in an 
increase in babies falling from changing tables or an increase in 
drowning incidents in bath tubs because parents would have to use both 
hands to open the package.
    Response: According to the CTFA, about 70 percent of baby oil is 
used on adults and not babies. The comment assumes that adults who use 
baby oil on children now use only one hand to open and squirt out the 
product. The CTFA provided no evidence to support this. Containers for 
other baby products, including tubes or jars, often require two hands 
to open or use. The labeling on baby powder, for example, instructs 
parents to sprinkle the powder into their hands and then rub it on the 
baby. The comment also assumes that two hands are required to open all 
child-resistant packaging. In fact, however, there are child-resistant 
designs that can be opened with one hand. Further, parents can open the 
baby oil container ahead of time. The Commission finds it highly 
unlikely that baby oil in child-resistant packaging would increase the 
number of falls and drowning incidents.

E. Injury Data

    The following section updates the ingestion data from household 
chemical products. The injury data reviewed at the time the ANPR was 
issued did not include cosmetic products. The CPSC staff has now 
reviewed ingestions of cosmetics product categories, including nail 
products, sunscreen and suntan preparations, bath oil and creams, 
lotions, and make-up, and the results are outlined below, along with a 
separate discussion of baby oil ingestion data.
    1. Household chemicals.
    The CPSC maintains the NEISS database of product-related injuries 
that were treated in hospital emergency rooms. The NEISS data are 
derived from a statistical sample of hospital emergency rooms in the 
United States. However, many ingestion exposures are handled by Poison 
Control Centers and are not treated in emergency rooms. The TESS 
database, which includes calls to poison control centers, is not a 
statistical sample, and the numbers of incidents cannot be used to make 
national estimates. The number of exposures reported in TESS represents 
a large percentage of the total calls to poison centers in a given 
year. However, the total annual number of ingestion incidents is likely 
to be greater than the actual number of cases reported in TESS.
    The CPSC staff examined the NEISS data for ingestions by children 
under 5 years of age for the years 1995 through 1997. The product 
categories examined include workshop chemicals, adhesives, lubricants, 
metal polishes, automotive chemicals, paints, varnishes, and shellacs, 
spot removers, and automotive waxes, polishes, and cleaners. There were 
an estimated 6,800  1,800 pediatric ingestions of these 
products seen in emergency rooms during the 3-year period.
    In addition, the CPSC purchases TESS data for children under 5 
years of age from the AAPCC each year. The data purchased include 
reported exposure calls. Informational calls are not purchased. The 
data do not include trade names. They are coded for broad product 
categories in a single code. The CPSC staff examined unintentional 
ingestion incidents from categories that contain products that may 
require child-resistant packaging under the regulation. These include 
carpet, upholstery, leather, or vinyl cleaners; automotive 
hydrocarbons; hydrocarbon spot removers; lubricants; other 
hydrocarbons; unknown hydrocarbons; other or unknown rust removers; 
floor wax, polish, or sealers; toluene or xylene adhesives; toluene or 
xylene; stains; and varnish and lacquers.
    There were 44,781 ingestions of these products recorded in TESS for 
the years 1995-1997 (12,592, 16,433, and 15,756, respectively). Of 
these ingestions, 612 cases were also coded as aspirations. According 
to TESS guidelines, aspiration cases are automatically coded as 
ingestions in the TESS system. Of the aspiration cases, 122 resulted in 
``moderate'' medical outcomes and 4 in ``major'' outcomes. No deaths 
from these product categories were reported during this period. A 
number of children had specific respiratory effects that were the 
direct result of the aspiration of the product. These include 31 cases 
of pneumonitis, 5 cases of respiratory depression, and 1 case of 
pulmonary edema.
    Not all products in these categories contain hydrocarbons or have a 
viscosity of less than 100 SUS at 100  deg.F. For example, many of the 
adhesives and lubricants may have viscosities higher than 100 SUS. 
However, the data demonstrate that children do access the types of 
household chemical products that can contain hazardous levels of 
hydrocarbons. If these products contain hydrocarbons and have 
viscosities less than 100 SUS at 100  deg.F, children are at risk of 
aspiration and pneumonia. If the products are not hazardous 
hydrocarbon-containing products, the proposed rule does not affect 
them.
    (2) Cosmetics.
    NEISS does not have specific codes for cosmetic products. 
Therefore, NEISS data are not included in the review of cosmetics 
ingestions. CPSC staff examined TESS data for the years 1995-1997 for 4 
general cosmetic categories known to have products that contain 
hydrocarbons. These include miscellaneous nail products, sunscreen and 
suntan preparations, bubble bath and bath oil, and creams, lotions, and 
make-up.
    There were 74,042 ingestions of these products recorded in TESS for 
the years 1995-1997 (21,850, 25,514, and 26,678, respectively). Of 
these ingestions, 114 cases were coded as aspirations. Of the 
aspiration cases, 5 resulted in ``moderate'' medical outcomes, 2 in 
``major'' outcomes, and 1 in a death (from baby oil). A number of 
children had specific respiratory effects that were the direct result 
of the aspiration of the product. These include 2 cases of pneumonitis, 
2 cases of respiratory depression, and 1 case of respiratory arrest.
    As stated previously, not all of the products in the categories 
contain hydrocarbons. For example, bath oil may contain hydrocarbons, 
but bubble bath is usually an aqueous detergent solution that would not 
be covered by the rule. In addition, not all of the hydrocarbon-
containing products in each category would require child-resistant 
packaging because they have viscosities of 100 SUS or more at 100 
deg.F. Creams and lotions that are emulsions would also not be 
included. For example, the staff collected a convenience sample of 5 
different tanning products labeled as containing mineral oil and 
measured the viscosities and percentages by weight of hydrocarbons in 
these products. Of the five tanning products collected, one was an 
emulsion (lotion), two were tanning oils with viscosities in the 240 
SUS range, and two were tanning oils with viscosities in the 65 SUS 
range. Only the latter two products would require child-resistant 
packaging under the proposed rule. This analysis cannot be extrapolated 
to identify the percentage of products in any category that may fall 
within the scope of the recommended rule. The example illustrates that 
there can be a range of viscosities in cosmetic products in the same 
category.

[[Page 99]]

    The cosmetic trade association argues that the aspiration hazard 
does not exist for cosmetic products. However, some companies warn 
about the possibility of serious injury on their labels, using the 
following: ``For external use only. Keep out of children's reach to 
avoid drinking and accidental inhalation, which can cause serious 
injury. Should breathing problems occur, consult a doctor 
immediately.'' The FDA does not require this warning. The FDCA (21 CFR 
740.1(a)) requires that ``the label of a cosmetic product bear a 
warning statement whenever necessary or appropriate to prevent a health 
hazard that may be associated with the product.''
    The TESS database documents aspirations from cosmetic products. In 
addition, the reported cases of serious injuries and a death from baby 
oil, regardless of the circumstances and whether child-resistant 
packaging would have prevented them, reinforce and support the 
potential hazard of these products. The viscosities of these products 
fall in the range where aspiration may be a hazard. The poisoning data 
indicate that children are accessing household chemicals and cosmetics 
that contain hydrocarbons. The potential for serious injury exists.
    (3) Baby oil.
    The Commission was specifically interested in incidents involving 
baby oil. A literature review documented one case of serious injury 
following aspiration of baby oil (Reyes de la Rocha, et al., 1985). The 
CTFA's comment documented a similar case that resulted in permanent 
impairment of a child. The limited details that the CTFA supplied did 
not directly correlate with the published case. The two cases may not 
be the same. Moreover, there was a death of a child following ingestion 
of baby oil documented by the AAPCC (Litovitz et al., 1997). The CPSC 
staff investigated the circumstances of the death (IDI 97030HCC9033); 
however, limited information was obtained. The child died 23 days after 
the ingestion. There was speculation that between 10 and 14 ounces of 
baby oil may have been ingested, although it was reported that the 
child was covered with baby oil. According to the AAPCC report a part 
of the cap was found in the child's stomach. The CTFA questioned the 
circumstances of this death. Nevertheless, the reported decrease in 
oxygen saturation and lung infiltration are consistent with aspiration 
pneumonitis.
    The CPSC purchased data on exposures to baby oil by children under 
5 years of age that AAPCC had compiled for the years 1996 and 1997. 
Over 2,500 incidents were reported during the 2-year period. Most of 
these cases involved ingestion. Most of the cases were managed at home. 
Several children exhibited symptoms and were admitted to the hospital. 
The CTFA also purchased these data and commented. It concluded that the 
data demonstrate the safety of baby oil.
    The Commission is concerned about products such as baby oil that 
use lightweight mineral oil and have viscosities in the 60-99 SUS 
range. The authors of one report of a case involving baby oil conclude 
that ``baby oil aspiration can be one of the causes of acute 
respiratory distress in children'' (Reyes de la Rocha, 1985). They 
advocate that the latent danger of baby oil needs to be publicized 
since it appears that baby oil is not recognized as a cause of diffuse 
pneumonia and respiratory distress. This was demonstrated in a recent 
case documented in NEISS (981026HEP9021). An infant was accidentally 
given baby oil. According to the mother, she was told by the poison 
control center and the pediatrician that the child would have diarrhea. 
However, 3 days later the child was admitted to the hospital with 
pneumonia. While child-resistant packaging would not have prevented 
this ingestion, the case illustrates the potential dangers of the 
lightweight-mineral-oil-based products with viscosities under 100 SUS.

F. Technical Feasibility, Practicability, and Appropriateness

    The PPPA standards for child-resistance and adult-use-effectiveness 
are defined in 16 CFR 1700.15 and are based on the results of human 
performance tests described in 16 CFR 1700.20. When tested according to 
the methods, 80 percent of tested children (41-52 months old) (based on 
200 children) must not be able to access the package. In addition, most 
packages must be accessible to 90% of tested adults aged 50-70. The 
exceptions to this are products that require metal containers with 
metal closures or aerosols. These products must be accessible to 90% of 
adults tested aged 18 to 45 (16 CFR 1700.15(b)(2)(ii)). When this 
notice refers to child-resistance, it also means that the package meets 
the senior standard, unless otherwise specified.
    Before issuing a regulation under the PPPA, the Commission must 
find that child-resistant packaging is technically feasible, 
practicable, and appropriate for the regulated products. 15 U.S.C. 
1472(a)(2). ``Technical feasibility'' may be found when technology 
exists or can be developed to produce packaging that conforms to the 
standards described above. ``Practicability'' means that packaging 
complying with the standards can utilize modern mass production and 
assembly line techniques. Packaging is ``appropriate'' when complying 
packaging will adequately protect the integrity of the substance and 
not interfere with its intended storage or use.
    The CPSC staff assessed the packaging of a range of products that 
may be included in the rule. Based on that assessment, the Commission 
believes that child-resistant packaging is technically feasible, 
practicable, and appropriate for hydrocarbon-containing products. There 
are currently three product categories that contain petroleum-derived 
hydrocarbons and for which child-resistant packaging is required (16 
CFR 1700.14(a)(2), (7), and (15)). Child-resistant packaging that meets 
the standards is available and compatible with these hydrocarbon-
containing products. Many of the products that would be included in the 
recommended rule are similar in composition and use. This section will 
summarize technical information to support the findings for the variety 
of packaging types commonly used for hydrocarbon-containing products.
    1. Continuous threaded packaging. Most packages that contain liquid 
products are currently sold with non-child-resistant continuous 
threaded (CT)(screw on) closures. These closures can be made of plastic 
or metal. This type of closure has been successfully modified to be 
child-resistant. There are several different types of child-resistant 
continuous threaded designs. The most common is the ASTM type IA 
closures. These are two-piece child-resistant closures that open by 
``pushing and turning.'' These types of closures are already being used 
on hydrocarbon-containing products, such as liquid furniture polish and 
mineral spirits. These and other types of continuous threaded closures 
are available from many different manufacturers. Stock closures are 
available and come in a variety of sizes, skirt lengths, and liner 
options. Plastic-on-metal closures are also available for products with 
solvents that may be incompatible with plastics.
    Closures are also available that can accept brush applicators. 
Smaller sizes of these closures may have to be developed to accommodate 
the small bottles used for nail dryers and nail moisturizers. These 
packages are very similar to those used for nail primers that contain 
methacrylic acid, for which the Commission recently required child-

[[Page 100]]

resistant packaging. 64 FR 32799 (June 18, 1999).
    In most cases, the development of new closures or sizes will be 
unnecessary. However, modifications to the bottle neck finish and/or to 
the existing sorting and capping equipment may be necessary to change 
from non-child-resistant to child-resistant continuous threaded 
packaging.
    (2) Dispensing packaging (inserts and flip-tops). The staff 
examined some cosmetic products that would be included in the 
recommended rule. Many baby oil, suntan oil, and bath oil products are 
currently packaged with dispensing capability. Several different 
packaging designs are being used, including restricted orifice plug 
inserts, flip-top dispensers, and finger pump dispensers.
    The plug inserts and the flip caps both function by decreasing the 
orifice of the opening of the bottle. The plug insert fits flush with 
the opening of the bottle and does not interfere with the function of 
the closure. A child-resistant continuous threaded closure can replace 
the existing non-child-resistant closure as described above. The CPSC 
is not aware of any commercially available child-resistant flip-top 
closures for liquids. However, plug inserts with child-resistant 
closures can be substituted and serve the same function. Plug inserts 
are compatible with mineral-oil-based cosmetics because several of the 
cosmetic products currently use plug inserts. Manufacturers may have to 
change bottle neck finishes or buy plug insert equipment if they are 
not currently using the inserts.
    (3) Pump dispensers. Some suntan oils are available with finger 
pumps. The Commission recently addressed the child-resistance of finger 
pumps during the minoxidil rulemaking. In a comment in that rulemaking, 
a manufacturer said that it could make a child-resistant finger pump. 
The finger sprayer for minoxidil has to be metered to deliver a 
specific dose. This is not the case for hydrocarbon-containing 
products; therefore, the development of a finger sprayer for these 
products should be less complicated.
    Companies using finger pumps have other options. Other products in 
this category use plug inserts as described above. In addition, there 
are several child-resistant overcaps being developed specifically for 
pump sprayers.
    Some of these alternatives are more complex than others and would 
require more time and money to complete.
    (4) Aerosols and trigger sprayers. Any product meeting the proposed 
requirements that is in aerosol, pump, or trigger sprayer packaging, 
and that is expelled as a stream, must be in a child-resistant package. 
Child-resistant aerosol overcaps are available on the market. There are 
several designs that are also senior friendly. Since the overcaps do 
not come in contact with the products, compatibility of overcaps is not 
an issue.
    For products that currently use a trigger sprayer, the CPSC is 
aware of a child-resistant trigger sprayer on the market and of several 
other designs under development. The Commission addressed the issue of 
child-resistant trigger sprayers during the fluoride rulemaking (63 FR 
29949).
    (5) Metal container closures. There are several designs, including 
snap caps and CT's, that are child-resistant and can be used with metal 
cans. These types of closures are currently being used on lighter 
fluids and some paint solvents. They are commercially available and 
compatible with hydrocarbons.
    The CPSC concludes that the available data support the finding that 
it is technically feasible, practicable, and appropriate to produce 
special packaging for products that contain 10 percent hydrocarbons or 
more by weight with a viscosity less than 100 SUS at 100  deg.F.

G. Effective Date

    The PPPA provides that no regulation shall take effect sooner than 
180 days or later than one year from the date such final regulation is 
issued, except that, for good cause, the Commission may establish an 
earlier effective date if it finds that it is in the public interest to 
do so. 15 U.S.C. 1471 note.
    This rulemaking covers diverse groups of products with diverse 
packaging. Some of the packaging changes may be minimal, while others 
may be more extensive. For example, even though there are child-
resistant packages readily available, changes from tool design to 
product-filling-line equipment may be required to replace some of the 
non-child-resistant packaging with various types of child-resistant 
packaging. In addition, there are multiple options available to 
manufacturers. Cost and consumer preference may play a role in 
determining which child-resistant feature is best suited to a product. 
Not all products in the same product category may take the same time to 
change to child-resistant packaging. However, the CPSC estimates that 
all of these packaging changes could be achieved within 1 year. 
Therefore, the Commission proposes an effective date of 1 year after 
publication of the final rule.

H. Economic Considerations

    1. Introduction. Under the Regulatory Flexibility Act, the 
Commission must, when proposing a rule, either assess the impact of a 
regulation on small entities or certify that there will not be a 
significant economic effect on a substantial number of small entities. 
This section summarizes information about the potential impact on small 
businesses for both household chemical products and cosmetics and about 
the likely costs of packaging. After considering the available 
information, and the factors referred to in 15 U.S.C. 1472(b), the 
Commission concludes that the proposed rule is reasonable.
    Three trade associations provided comments on economic issues: the 
Arts & Creative Materials Institute (``ACMI''); CSMA; and CTFA. The 
comments focused on (1) costs of child-resistant packaging for specific 
types of packaging or products and (2) the effects of the proposal on 
some manufacturers because of the uniqueness of their products. Only a 
few individual companies provided comments relating to economic issues.
    Below, the Commission provides information on the products likely 
to contain hydrocarbons with characteristics subject to the proposal. 
Hydrocarbon-containing products regulated under the FHSA and FDCA are 
discussed separately.
    2. Hydrocarbon-containing products regulated under the FHSA.
    (a) Market information. Hydrocarbon-containing products for 
consumer use that are regulated under the FHSA appear in many product 
categories, including adhesives, air fresheners, all purpose cleaners, 
all purpose lubricants, art materials such as markers, automotive 
fluids and cleaners, metal cleaners and polishes, paint solvents, shoe 
polishes, spot removers, and water repellents. The products are 
dispensed in aerosol, gel, liquid and solid form.
    Based on a survey of just a ``few'' of its 400 member companies, 
the CSMA reported that an average of about 80 million units of 
hydrocarbon-containing products are sold annually. The CSMA said its 
members consider product formulation to be confidential business 
information. One individual company reported annual average sales of 
about 2 million units of hydrocarbon-containing products in bottles and 
cans. However, no information on product categories or formulations was 
provided.
    Table I provides 1996 dollar and unit sales for some categories of 
automotive and household cleaning products that

[[Page 101]]

are likely to contain products formulated with hydrocarbons. However, 
the data do not reveal the share of the market attributable to 
hydrocarbon-containing products with characteristics that meet the 
criteria for the proposed rule or that are now packaged in child-
resistant packaging.

    Table 1.--Selected Household Product Categories Likely To Contain
                  Products Formulated With Hydrocarbons
------------------------------------------------------------------------
                                                               Average
         Product category            $ Sales     Units \1\      retail
                                    (millions)   (millions)   price ($)
------------------------------------------------------------------------
Auto treatments/ other auto              276.9        164.6         1.68
 fluids..........................
Auto waxes/polishes..............        218.5         83.9         2.60
Furniture polish.................        212.0         54.0         3.93
Floor cleaners, wax, wax removers        109.7         47.6         2.30
Shoe/vinyl polish, cleaner/wax...         31.0         13.1         2.37
Specialty cleaner, polish........         48.4          9.5         5.09
Household lubricants.............         13.6          7.1        1.92
------------------------------------------------------------------------
Source: Share Facts, Find/SVP, 1996
\1\ Units are defined by Share Facts as 16 oz. equivalents

    The Table 1 data do not include paints, coatings, or art materials. 
Although the National Paint and Coating Association (``NPCA''), which 
represents about half of the manufacturers or fillers of aerosol 
paints, noted that many aerosol paint formulas contain hydrocarbons, 
the association did not provide unit or dollar sales for these 
products. However, products packaged in aerosol containers that deliver 
a fine mist spray would not be subject to the proposed rule. 
Additionally, non-aerosol paints are not subject to the proposed rule 
because of their high viscosity.
    The ACMI represents about 200 member companies that manufacture art 
and creative materials. ACMI surveyed its members and reported that 
less than 60 (exact number unknown) sell products that the proposal 
would cover. The association wrote that the products to which the 
proposal would apply are fairly specialized products used by adults 
(product types unspecified) in the art/hobby fields and that the 
products may not have a large sales volume. ACMI did not provide unit 
or dollar sales.
    (b) Packaging costs. Neither the ACMI nor CSMA provided information 
on the potential costs of providing child-resistant packaging for their 
members' products. The ACMI reported that its members did not provide 
sufficient cost-related information to respond to the request. ACMI 
wrote that some member manufacturers are voluntarily using child-
resistant packaging for certain hazardous products and that since 
members ``tend to support the proposal and have products already in 
child-resistant packaging, it would not appear to raise major cost 
obstacles.''
    While neither ACMI nor CSMA provided information on potential 
costs, it might be noted that incremental costs for child-resistant 
packaging typically range from $0.005 to $0.02 per package. For 
products using a recently developed child-resistant trigger spray, 
incremental costs will amount to about $0.025 per package.
    (c) Small business effects. The Commission does not know the 
universe of companies that would be affected by the proposed 
requirement. At least 1,500 large and small companies were notified of 
the proposal through trade associations and individual mailings. 
However, the responses to the ANPR provided no information indicating 
that small businesses would be significantly affected by the proposed 
child-resistant-packaging requirement. Additionally, there are several 
reasons to believe that the proposed rule would not have a significant 
impact on affected companies. Some manufacturers of household products 
that are subject to the proposal are currently providing child-
resistant packaging. Manufacturers of household products typically have 
diverse product lines that also include product formulations that would 
not be included under the proposal. Thus, the number of products that 
would require child-resistant packaging may represent a small 
proportion of a firm's production. Finally, the firms would be able to 
exhaust existing inventory, since the rule would not apply to products 
packaged before the effective date.
    Only two individual small companies commented on the packaging 
costs that would be incurred to convert their products to child-
resistant packaging. While both indicated there would be an economic 
burden, neither provided specific cost information. The product of one 
company is packaged in an aerosol container and delivers a fine mist 
spray; the product of the other company is packaged in a tube with a 
restricted-flow moist-fiber applicator tip. Neither of these package 
types would be covered under the proposed rule; thus, the proposal will 
have no effect on these companies.
    Based on the response to the ANPR, and the wide availability and 
relatively small incremental costs of child-resistant packaging, the 
Commission certifies that the proposed rule, if promulgated and as it 
relates to products regulated under the FHSA, will not have a 
significant economic effect on a substantial number of small entities.
    3. Hydrocarbon-containing products regulated under the FDCA.
    (a) Market information. Mineral oil, a hydrocarbon available in a 
wide range of viscosities, is used in a number of personal care 
products regulated under the FDCA. Products containing mineral oil and 
having a low viscosity, such as some baby oils, bath, massage, and 
sensual aroma oils, eye makeup removers, and nail care and sun care 
preparations, would also be covered under the proposed rule. While many 
of these products are typically sold separately, others are sold as 
part of a gift box that includes several items, for example, fragrant 
bath oil packaged with a soap and powder. The products may have 
aerosol, foam, gel, liquid, lotion, and solid formulations, and use a 
variety of delivery systems.
    The CTFA, which represents about 275 manufacturers of cosmetic 
products, commented that most cosmetics product categories containing 
mineral oil are marketed in solid form and thus do not present an 
aspiration hazard. The association also noted that only a few of the 
cosmetics in liquid form would be subject to the contemplated child-
resistant packaging requirement. This is because most exceed the 
viscosity limit and/or contain less than 10% hydrocarbons.
    Many baby oil products are available in cream, lotion, and gel 
formulations.

[[Page 102]]

The proposed rule will not affect these products because of their high 
viscosity. Similarly, the proposal will not affect many sun care 
products because of their high viscosities (creams, gels, lotions, 
solid sticks) or because they do not contain hydrocarbons.
    In response to the ANPR, CTFA sent a survey to over 200 
representatives of member companies and received only 15 completed 
surveys. CTFA reported that some companies returned the survey stating 
that they used no hydrocarbons, they were not currently marketing 
subject products, or their products were not for household use. In 
addition to products containing hydrocarbons, most manufacturers of 
cosmetics typically have extensive product lines and use various 
formulations without hydrocarbons. The association summarized member 
comments and provided information only by product category, without 
identifying brands or companies. There was no indication as to whether 
the responding companies were ``small'' or ``large'' businesses. Only 
manufacturers of baby oil provided market share and unit sales data in 
response to the survey. Based on these data, CPSC staff estimates the 
annual sales of baby oil at about 35 million units.
    For all cosmetic product categories, Drug Topics (May 5, 1997) 
indicated that sales amounted to $2.9 billion and 911.5 million units 
in 1996. No breakout by type of product was given. However, the trade 
publication Happi (March 1996) reported that sun care products, a 
cosmetics category with some hydrocarbon-containing preparations, had 
$393.8 million in sales (almost 70 million units) in drug, food, and 
mass merchandise stores in 1995. However, Happi did not provide a 
breakout of the products that make up the sun care category, which 
includes sunscreens/sunblocks, self-tanners, and after-sun 
preparations.
    (b) Packaging costs. Packaging for cosmetic products that may 
contain mineral oil currently includes finger press and pump 
dispensers, continuous threaded closures, flip tops with restricted 
orifices, finger spray pumps, and trigger sprays. Some nail care 
products are packaged with a plug insert restricted-neck fitting in the 
bottle's neck to remove excess product from the applicator brush.
    According to a leading closure manufacturer, incremental costs for 
some types of child-resistant packaging that can be used for baby oil, 
sun care, and other mineral-oil-containing cosmetics are about $0.01 
per unit (depending upon size, quantity ordered, and color). These 
package types include a commercially available package with a child-
resistant closure and a restricted-neck fitting, and a dispensing cap 
with a flip top is under development. CTFA commented that a marketer of 
eye makeup remover reported the incremental cost for child-resistant 
packaging for the company's product would amount to 1.5 cents. 
Additionally, the incremental cost for a recently developed child-
resistant trigger spray is about $0.025 per unit.
    There is an unknown quantity of nail care products that the 
proposal may affect. Samples of mineral-oil-containing cuticle and nail 
oils CPSC staff examined were packaged with 13-20mm diameter neck 
finishes on bottles with built-in applicator brushes. They contain 0.4 
to 1.0 oz of product. It may be necessary for some suppliers to change 
the closure and bottle finish in order to accommodate potentially 
available child-resistant packaging. There are at least two U.S.-based 
packaging manufacturers that could develop child-resistant closures 
with applicator brushes. No information is available regarding the 
incremental cost of such packaging.
    In addition to the incremental cost of child-resistant packaging, 
manufacturers may also incur one-time start-up costs. Initial costs 
vary widely according to the product and to the extent of package 
redesign. CTFA provided estimates of one-time packaging costs based on 
the member survey noted earlier. The estimates for child-resistant 
packaging for baby oil, bath oil, and sunscreen products ranged from 
$163,000 to $1.5 million and, depending upon manufacturer, included 
research and development, new bottle molds, new custom-designed caps, 
and new tooling for product-filling lines. No specific information was 
provided to support these costs.
    One manufacturer, providing comments independent of the CTFA, 
estimated the start-up costs for child-resistant packaging for baby oil 
at $122,000 for tooling and changing parts, assuming that only the 
closure changed and bottle shapes and sizes were not affected. The 
estimates for tooling and changing parts for child-resistant packaging 
for a tanning oil, moisture lotion, and bath oil ranged from $6,100 to 
$85,100.
    (c) Small business effects. The concerns of some cosmetics 
manufacturers center on the need for custom-design packaging, 
especially for products with small markets, and on the effect of using 
child-resistant packaging on exports. As noted earlier, CTFA did not 
provide information regarding the identity of responding companies; 
thus, the Commission does not know if these manufacturers are small 
businesses. The high start-up cost estimates for custom-design child-
resistant packaging were discussed above. One unidentified CTFA member 
commented that ``packaging aesthetics is an integral element of 
cosmetics and [is] a key factor in packaging decisions and ultimately, 
consumer purchases.'' Several companies indicated that they would be 
forced to discontinue various products if child-resistant closures were 
required, because product sales would not support the costs of 
providing the packaging. Data regarding types of product, formulation, 
sales volume, and projected packaging costs were not provided.
    A number of CTFA member companies also expressed concerns regarding 
exports of child-resistant packaged cosmetics. According to CTFA, 
packaging requirements for cosmetics would adversely impact global 
sales because ``of a negative consumer perception in foreign countries 
about the safety of the U.S. product with a child-resistant closure 
versus the foreign competitor's product that is not child resistant.'' 
The association also commented that a foreign competitor's packaging 
cost could be lower than the U.S. product with a child-resistant 
closure and that consumers would buy the cheaper product in many cases. 
The association did not provide comparisons between foreign and 
domestic costs or data regarding the value of exports that the proposal 
may impact. The proposed rule does not require companies that export 
affected cosmetic products to use child-resistant packaging for their 
exports.
    CTFA reports that one member company manufacturing a massage oil 
packaged with a continuous threaded closure and a restricted flow 
opening would drop the product rather than provide child-resistant 
packaging. According to CTFA, the product, selling at retail for $26 
(6.7 oz) has low sales volume that does not make it ``worth the 
investment to refit with special packaging.'' No estimate of the 
magnitude of the investment for child-resistant packaging was provided. 
Additionally, CTFA reported that one manufacturer of nail products said 
it would discontinue two products if child-resistant packaging were 
required. A second nail-product manufacturer anticipated that child-
resistant packaging would cost several thousand dollars for custom cap 
retooling and result in a 40% increase (unstated dollar value) in 
ongoing packaging costs. The size of these businesses is unknown.

[[Page 103]]

    The Commission does not know the universe of companies that would 
be affected by the proposed requirement for child-resistant packaging 
for products regulated under the FDCA. The Commission requests that 
suppliers, especially small businesses and organizations representing 
small businesses, provide specific information about their products and 
the effect the proposed rule would have on them. The responses to the 
ANPR did not indicate that many small businesses would be affected. The 
wide availability and relatively small incremental costs of child-
resistant packaging relative to the retail price of cosmetic products 
suggest that few firms should have a significant economic burden.
    Based on the economic information available on the proposed rule 
affecting products regulated under the FDCA, the Commission certifies 
that the proposed rule, if promulgated, would not have a significant 
economic effect on a substantial number of small entities.

I. Preliminary Environmental Assessment

    Pursuant to the National Environmental Policy Act, and in 
accordance with the Council on Environmental Quality regulations and 
CPSC procedures for environmental review, the Commission has 
preliminarily assessed the possible environmental effects associated 
with the proposed packaging requirements for household products that 
contain hydrocarbons of low viscosity.
    The Commission's regulations at 16 CFR 1021.5(c)(3) state that the 
rules requiring special packaging for consumer products normally have 
little or no potential for affecting the human environment. Preliminary 
analysis of the impact of this proposed rule indicates that child-
resistant packaging requirements for the production of marketers of 
low-viscosity hydrocarbon-containing products under the proposed rule 
will have no significant effects on the environment. The manufacture, 
use, and disposal of child-resistant closures will present the same 
environmental effects as do non-child-resistant closures.

J. Executive Orders

    This proposed rule has been evaluated in accordance with Executive 
Order No. 13,083, and the rule raises no substantial federalism 
concerns.
    Executive Order No. 12,988 requires agencies to state the 
preemptive effect, if any, to be given the regulation. The preemptive 
effects of these rules is established by Section 7 of the PPPA, which 
states:

    (a) * * * whenever a standard * * * under [the PPPA] applicable 
to a household substance is in effect, no State or political 
subdivision of a State shall have any authority either to establish 
or continue in effect, with respect to such household substance, any 
standard for special packaging (and any exemption therefrom and 
requirement related thereto) which is not identical to the [PPPA] 
standard [and exemption, etc.].

15 U.S.C. 1476(a).
    Subsection (b) of 15 U.S.C. 1476 provides a circumstance under 
which subsection (a) does not prevent the Federal Government or the 
government of any State or political subdivision of a State from 
establishing or continuing in effect a special packaging requirement 
applicable to a household substance for its own [governmental] use, and 
which is not identical to the standard applicable to the product under 
the PPPA. This occurs if the Federal, State, or political subdivision 
requirement provides a higher degree of protection from such risk of 
injury than the consumer product safety standard.
    Subsection (c) of 15 U.S.C. 1476 authorizes a State or a political 
subdivision of a State to request an exemption from the preemptive 
effect of a special packaging requirement. The Commission may grant 
such a request, by rule, where the State or political subdivision 
standard or regulation (1) would not cause the household substance to 
be in violation of the Federal standard, (2) provides a significantly 
higher degree of protection from the risk of injury than does the 
Federal standard and (3) does not unduly burden interstate commerce.

K. Trade Secret or Proprietary Information

    Any person responding to this notice who believes that any 
information submitted is trade secret or proprietary should 
specifically identify the exact portions of the document claimed to be 
confidential. 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 the Commission concludes that any part of 
information that has been submitted with a claim that the information 
is a trade secret or proprietary is disclosable, it will notify the 
person submitting the material in writing and provide at least 10 
calendar days from the receipt of the letter for that person to seek 
judicial relief. 15 U.S.C. 2055(a)(5) and (6); 16 CFR 1015.19(b).

List of Subjects in 16 CFR Part 1700

    Consumer protection, Drugs, Infants and children, Packaging and 
containers, Poison prevention, Reporting and recordkeeping 
requirements.

    Effective date. The Commission proposes that the rule become 
effective 1 year after publication of the final rule. This period will 
allow manufacturers to make any changes in their production needed to 
comply with the standard without unduly delaying the safety benefits 
expected from the rule.
    For the reasons set out in the preamble, the Commission proposes to 
amend 16 CFR 1700.14 as set forth below.
    1. The authority citation for part 1700 continues to read as 
follows:

    Authority: 15 U.S.C. 1471-1476.
    Secs. 1700.1 and 1700.14 also issued under 15 U.S.C. 2079(a).

    2. In Sec. 1700.14 add new paragraphs (a)(30) and (a)(31) to read 
as follows:


Sec. 1700.14  Substance requiring special packaging.

    (a) * * *
    (30) Hazardous substances containing low-viscosity hydrocarbons. 
All prepackaged nonemulsion-type liquid household chemical products 
that are hazardous substances as defined in the Federal Hazardous 
Substances Act (FHSA) (15 U.S.C. 1261(f)), and that contain 10 percent 
or more hydrocarbons by weight and have a viscosity of less than 100 
SUS at 100 deg. F, shall be packaged in accordance with the provisions 
of Sec. 1700.15(a), (b), and (c), except for the following:
    (i) Products in packages in which the only non-child-resistant 
access to the

[[Page 104]]

contents is by a spray device (e.g., aerosols or pump-or trigger-
actuated sprays) that expels the product solely as a mist. This 
exemption includes products that expel the product as a mist in their 
as-sold condition, but that can be modified by adding a tube to expel 
the product as a stream.
    (ii) Writing markers and ballpoint pens exempted from labeling 
requirements under the FHSA by 16 CFR 1500.83.
    (iii) Products from which the liquid cannot flow freely, including 
but not limited to paint markers and battery terminal cleaners. For the 
purposes of this requirement, hydrocarbons are defined as substances 
that consist solely of carbon and hydrogen. For products that contain 
multiple hydrocarbons, the total percentage of hydrocarbon in the 
product is calculated by adding the percentage by weight of the 
individual hydrocarbon components.
    (31) Drugs and cosmetics containing low-viscosity hydrocarbons. All 
prepackaged nonemulsion-type liquid household chemical products that 
are drugs or cosmetics as defined in the Federal Food, Drug, and 
Cosmetics Act (FDCA) (21 U.S.C. 321(a)), and that contain 10 percent or 
more hydrocarbons by weight and have a viscosity of less than 100 SUS 
at 100 deg. F, shall be packaged in accordance with the provisions of 
Sec. 1700.15(a), (b), and (c), except for the following:
    (i) Products in packages in which the only non-child-resistant 
access to the contents is by a spray device (e.g., aerosols or pump- or 
trigger-actuated sprays) that expels the product solely as a mist. This 
exemption includes products that expel the product as a mist in their 
as-sold condition, but that can be modified by adding a tube to expel 
the product as a stream.
    (ii) Products from which the liquid cannot flow freely, including 
but not limited to makeup removal pads. For the purposes of this 
requirement, hydrocarbons are defined as substances that consist solely 
of carbon and hydrogen. For products that contain multiple 
hydrocarbons, the total percentage of hydrocarbon in the product is 
calculated by adding the percentage by weight of the individual 
hydrocarbon components.
* * * * *
    Dated: December 23, 1999.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 99-33770 Filed 12-30-99; 8:45 am]
BILLING CODE 6355-01-P