[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
cpsc-os@cpsc.gov. 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
