Household Products Containing Hydrocarbons; Final Rules
[Federal Register: October 25, 2001 (Volume 66, Number 207)]
[Rules and Regulations]
[Page 53951-53957]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25oc01-6]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR 1700
Household Products Containing Hydrocarbons; Final Rules
AGENCY: Consumer Product Safety Commission.
ACTION: Final Rules.
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SUMMARY: These rules, promulgated under authority of the Poison
Prevention Packaging Act (PPPA), require child-resistant (CR) packaging
for certain products that contain low-viscosity hydrocarbons. (The
Commission voted 3-0 to issue this final rule. The statements of
Chairman Brown and Commissioners Gall and Moore concerning the vote are
available from the CPSC Office of the Secretary.) This requirement is
intended to protect children under five years of age from serious
injury associated with aspiration of hydrocarbon products. The
requirement applies to certain prepackaged nonemulsion-type liquid
household chemical products, including drugs and cosmetics, that
contain ten (10) percent or more hydrocarbons by weight and have a
viscosity of less than one hundred (100) Saybolt Universal Seconds
(SUS) at 100 deg.F (covered products). For purposes of these rules,
hydrocarbons are defined as compounds that consist solely of carbon and
hydrogen. For a product that contains multiple hydrocarbons, the total
percentage of hydrocarbons in the product is the sum of the percentages
by weight of the individual hydrocarbon components.
DATES: These rules become effective October 25, 2002, and apply to
covered products packaged on or after that date.
ADDRESSES: Copies of documents relevant to this rulemaking can be
[[Page 53952]]
requested from the Office of the Secretary, Consumer Product Safety
Commission, Washington, D.C. 20207-0001, (301) 504-0800, e-mail cpsc-
os@cpsc.gov, or in person at Room 502, 4330 East-West Highway,
Bethesda, Maryland.
FOR FURTHER INFORMATION CONTACT: Geri Smith, Office of Compliance,
Consumer Product Safety Commission, Washington, DC 20207; telephone
(301) 504-0608, ext. 1160.
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 or
Commission) to require child-resistant (CR) packaging of hazardous
household substances in appropriate cases. These rules require CR
packaging for certain low-viscosity hydrocarbon products.
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.
These chemicals are the primary ingredients in a multitude of 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
a liquid to flow. Liquids with high viscosities are thick or
``syrupy.'' Liquids with low viscosities are more ``watery.'' Products
with low viscosity pose a greater risk of aspiration into the lungs.
Under regulations issued pursuant to the Federal Hazardous
Substances Act (FHSA), 15 U.S.C. 1261-1278, the CPSC regulates the
labeling of hazardous household substances containing 10 percent or
more by weight of petroleum distillate hydrocarbons because these
products may cause injury or illness if ingested. 16 CFR 1500.14. The
PPPA regulations in effect as of this date also require child-resistant
packaging for certain household products containing petroleum
distillates. 16 CFR 1700.14. Under these regulations, the specified
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 as a chemical class
under the PPPA, many other hydrocarbon-based consumer products are not
required to be in child-resistant packaging. 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. For example, an 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 January 3, 2000, the CPSC issued a Notice of Proposed Rulemaking
(NPR) proposing CR packaging requirements for consumer products that
contain hydrocarbons of low viscosity. 65 FR 93.
The Commission proposed two discrete rules, one for products
regulated under the FHSA and the other for products regulated under the
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301-397. The proposed
rules would require CR packaging of prepackaged nonemulsion-type liquid
household chemical products or drugs and cosmetics that contain 10
percent or more hydrocarbons \1\ by weight and have a viscosity of less
than 100 SUS at 100 deg.F. For products that contain multiple
hydrocarbons, the total percentage of hydrocarbons in the product is
calculated by adding the percentage by weight of the individual
hydrocarbon components.
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\1\ Hydrocarbons are defined for purposes of these rules as
compounds that consist solely of carbon and hydrogen.
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The NPR outlined several packaging types that would be exempted
from the rules. These included products packaged in aerosol cans, and
mechanical pumps or trigger sprayers, provided the aerosol, mechanical
pump, or trigger sprayer expelled the product as a mist. For mechanical
pumps and trigger sprayers, the spray mechanism would be required to be
permanently attached to the bottle or have a CR attachment. However, if
the mechanical pump or trigger sprayer expelled product as a stream
(either solely or as an option), the entire package including the pump
mechanism would have been required to be CR. Aerosol products that
formed a stream by the addition of an extension tube inserted into the
nozzle would have been excluded from the packaging requirements if,
without the extension tube, the product would be expelled as a mist.
Writing markers and ballpoint pens are exempted from full
cautionary labeling requirements under the FHSA relating to ingestion
toxicity if they meet certain specifications prescribed by regulation.
16 CFR 1500.83. The Commission proposed that these products also be
exempted from CR packaging requirements. In addition, the NPR proposed
that cosmetics and other household substances, such as battery terminal
cleaners, paint markers, and make-up removal pads, that do not have
product free flowing from the packaging, be excluded from the CR
packaging requirements, even if they contained 10 percent or more
hydrocarbons by weight and have a viscosity under 100 SUS.
The NPR was sent to 375 trade associations and businesses believed
to be involved with hydrocarbon-containing products. Seven individuals
and groups submitted comments. Most of the comments focused on which
products should be subject to the rules. Many of them reiterated
comments that were previously submitted in response to the advance
notice of proposed rulemaking (ANPR) and addressed in the NPR.
Several commenters requested a test method to define ``stream'' for
aerosol and pump and trigger spray products. Aerosols and the discharge
from pump and trigger spray mechanisms are not subject to the final
rules being issued today. The CPSC expects to address the ``stream''
vs. ``mist'' issue in a subsequent proceeding.
At the Commission meeting on December 3, 1999, Commissioner Gall
requested that the CPSC staff develop a plan for the collection of
additional data related to ingestion incidents involving mineral oil-
based cosmetics. To this end, the Commission approved the purchase from
the American Association of Poison Control Centers (AAPCC) of
additional information on exposures to mineral oil-based cosmetics.
These data were evaluated by the CPSC staff. In an April 11, 2001
supplemental Federal Register notice of data availability, the
Commission provided an opportunity for the public to comment on this
information. 66 FR 18738. The comment period, which was extended at the
request of the Cosmetic, Toiletry, and Fragrance Association (CTFA),
ended on June 11, 2001. Four
[[Page 53953]]
comments were received in response to the notice.
The comments on the NPR and the additional data, the CPSC's
responses, the scope of these final rules, and the Commission findings
required under the PPPA for issuance of the rules, are discussed below.
B. Response to Comments on the NPR
1. Mechanical Pumps and Trigger Sprayers
Comment: One commenter (CP00-1-6) requested that the language of
the proposed provision that would exempt pump-or trigger-actuated
sprays that form a mist be modified to state clearly that the exemption
is only available for pump/trigger sprays that have the pumping unit
permanently affixed to the product container.
Response: The exemption provision proposed in the NPR read,
``Products in packages in which the only non-CR 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.'' The phrase ``the only non-
child-resistant access to the contents is by a spray device''
implicitly requires that the trigger or pump have either a permanent or
a CR attachment to the package.
The final rules being issued today do not cover aerosols or pump or
trigger spray mechanisms. However, irrespective of the absence from the
final rules of a requirement for the aerosol or pump/trigger spray
mechanism itself to be child-resistant, products in trigger or pump
sprayers that contain 10 percent or more hydrocarbons by weight and
have a viscosity of less than 100 SUS at 100 deg. F must still have
either a CR or permanent attachment to the product container. The
language of the final rules clarifies this requirement.
Comment: One commenter (CP00-1-4) suggested that senior testing
should not be required for assessing the removability of a trigger
sprayer from the product container because a senior does not need to
remove the trigger mechanism to use the product.
Response: Mechanical pumps and trigger sprayers have two routes of
access to the package contents--via the spray mechanism and via the
attachment of the spray mechanism to the product container. Companies
have two options concerning the attachment of the sprayer to the
container. The sprayer can be either permanently attached or have a CR
attachment. A CR attachment is required if the container is refillable.
The senior test protocol at 16 CFR 1700.20 directs that the senior
adults on the test panel open and close the packaging properly
according to the instructions found on the package. If the instructions
for use are to operate the trigger, this feature should be tested (for
a product where the trigger mechanism is required to be child-
resistant). If no instructions are found, activation of the trigger
would still be considered the ``normal usage'' of the package. This
approach is consistent with the commenter's view. However, if the
trigger mechanism itself is removable, manufacturers would need to test
to see if senior adults could remove and properly replace the trigger
sprayer mechanism onto the product container.
2. Single-Use Products
Comment: A comment (CP00-1-1) was received requesting that products
intended for ``total package use'' not require CR packaging. The
commenter supported the addition of a labeling statement, and provided
as an example, ``Add entire contents to gasoline tank.''
Response: This comment was addressed previously in the preamble of
the NPR. CPSC reiterates that any regulated product that is intended to
be fully used in a single application must meet the child-resistance
and adult-use-effectiveness specifications for the first opening, since
regulations require that the CR packaging be effective for the life of
the product. However, for example, an automotive additive would not
necessarily be a ``single-use-product'' if only a portion of the
contents were to be added to certain engine sizes.
Comment: Two commenters (CP00-1-4, 5) requested that language be
added to the rules to address single-use products. They suggested,
``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.''
Response: Additional language is not necessary in the rules to
address CR packaging of single-use-products. The regulation clearly
states that special packaging must continue to function for the number
of openings and closings customary for its size and contents. 16 CFR
1700.15(a). One opening would be customary for a single-use product.
3. Turpentine
Comment: One commenter (CP00-1-7) requested that the CR packaging
requirement of the proposed rules be applied to turpentine with a
viscosity level of less than 100 SUS at 100 deg. F in addition to
hydrocarbons.
Response: While turpentine presents an aspiration hazard,
turpentine is also readily absorbed following ingestion and systemic
toxicity can result. The systemic toxicity associated with turpentine
is different from the hazards of many hydrocarbons which have low
systemic toxicity but a significant risk of chemical pneumonitis
following aspiration. Turpentine, if ingested, is hazardous regardless
of the viscosity. Liquid household products that contain 10 percent or
more turpentine by weight now require CR packaging. 16 CFR
1700.14(a)(6). These final rules do not amend or supersede the
turpentine CR packaging regulation, which remains applicable without
regard to the viscosity of the turpentine product.
4. Writing Instruments
Comment: One commenter (CP00-1-7) stated a concern that if a marker
contained a substance newly covered by these final rules that was not
exempted from FHSA labeling, the marker would require CR packaging.
Response: In the NPR, the Commission proposed an exemption from CR
packaging for hydrocarbon-containing writing implements exempted from
the FHSA labeling requirements. 16 CFR 1500.83. In addition, the
Commission proposed to exempt products from which the liquid could not
flow freely. This would include paint markers or other such products
not exempted from the FHSA labeling regulations. Therefore, under the
rules as proposed, if a marker contained a ``hydrocarbon'' not
specifically exempted from the FHSA labeling requirements, it would
still not require CR packaging if the hydrocarbon did not freely flow
from the implement. However, the proposed exemption would not extend to
substances beyond ``hydrocarbons'' as defined in the proposed rule. The
final rules issued today adopt these exemption provisions.
5. Effective Date
Comment: Two commenters (CP-00-1-4, 5) stated that an effective
date of at least one year was appropriate. The commenters requested
that the Commission incorporate a procedure for companies to apply for
a temporary stay of enforcement as was done previously in the CPSC
rulemaking to revise the CR packaging protocol test methods. 60 FR
37710.
Response: The Commission believes that one year is sufficient for
manufacturers to adopt CR packaging for hydrocarbon-containing
products. The commenter provided no specific information that would
demonstrate the need for additional time. The
[[Page 53954]]
Commission is not including a special procedure for the submission of
requests for stays of enforcement as was done in the previous CPSC
rulemaking to revise the CR packaging protocol test methods. The large
volume of products affected by that rule, the technical difficulties
involved with changing many different closure types, and the
availability of a large supply of CR closures justified the
incorporation of a special procedure. This rulemaking does not involve
those considerations. However, a company can request a stay of
enforcement from the Commission or enforcement discretion from the CPSC
Office of Compliance at any time on a case by case basis.
Comment: One commenter (CP00-1-2) requested that the effective date
take into account the schedule for the development and marketing of
suntan products, which have a long lead-time. In addition, the
commenter stated that products not sold in one season may be held until
the next year's season.
Response: The PPPA requires that no standard take effect later than
one year from the date a rule is issued. 15 U.S.C. 1471n. However, the
standard applies only to products packaged on or after the effective
date. Therefore, suntan products packaged before the effective date but
sold thereafter are not subject to the rules. According to the
commenter, the timing of bringing products to market is over a year.
However, the schedule from product development to packaging described
in the commenter's submission is less than one year. (Product lines are
decided by December and production of those lines begins in August of
the following year.) The one-year effective date thus allows ample time
for suntan products subject to these final rules to comply with the CR
packaging requirement.
6. Additional Data on Mineral Oil-Based Cosmetics
The following comments were received in response to the Federal
Register notice providing a public comment period on the CPSC staff
analysis of the additional brand name data purchased from the AAPCC on
exposures to mineral oil-based cosmetics. 66 FR 18738-40 (April 11,
2001). Also, two commenters submitted comments about aerosol products.
Since, as was stated previously, the final rules issued today do not
apply to aerosols, these comments are not addressed here.
Comment: One commenter (CP-01-3-1) stated that it was important
that the CPSC identify all cosmetic products that would meet the
criteria for requiring CR packaging.
Response: Applicability of the proposed rules is based on the
physical and chemical characteristics of the product, not its product
category. That is, any product that contains 10 percent hydrocarbons or
more by weight with a viscosity less than 100 SUS at 100 deg.F is
required to be in CR packaging, unless otherwise exempted. The purpose
of the rules promulgated today is to protect children from exposure to
any product that contains low viscosity hydrocarbons that have the
potential for serious injury. The CPSC staff solicited information
about products and categories of products that might be subject to the
rules to assess their scope and to determine if CR packaging is
available or can be developed for those types of products. Under these
final rules, it is the responsibility of the packager of a product
exhibiting the specified physical and chemical characteristics to
comply. What category the product type happens to fall within is
irrelevant.
Comment: One commenter (CP-01-3-4) stated that the TESS data and
staff analyses are not valid for making the conclusion that mineral
oil-containing cosmetics require CR packaging.
Response: The TESS database is a specialized data collection system
that contains information about calls to Poison Control Centers. The
staff agrees that there are limitations to the TESS data. However,
these data support the fact that children do access cosmetic products
that contain hydrocarbons. See, 66 FR 18739 (April 11, 2001) (The CPSC
staff analysis of the additional data on mineral oil-based cosmetics
shows at least 1,460 cases of access). CTFA in its comment concurs that
the data demonstrate that children access mineral oil-based cosmetics.
If these products, or any others, have 10 percent or more hydrocarbons
by weight with a viscosity less than 100 SUS at 100 deg.F, serious
injury could result from ingestion with accompanying aspiration. The
TESS data simply further confirm this.
Comment: One commenter (CP-01-3-4) stated that the data show a low
incidence of serious injuries and that several of the deaths would not
have been prevented by CR packaging.
Response: The PPPA does not require a minimum number of deaths and
serious injuries before the Commission can proceed with a child-
resistant packaging rule. Rather, the PPPA requires that the Commission
find that a substance is capable of causing serious injury or illness
to young children that are exposed to it. The purpose of the human
experience data is to demonstrate that children access products that
may contain hydrocarbons and to further validate the fact that
aspiration of hydrocarbon-containing products with viscosities under
100 SUS at 100 deg.F can result in serious injury. The data presented
demonstrate these points. 66 FR 18739. However, the commenter states
that the descriptions of the incidents do not support the conclusion
that child-resistant packaging would have protected these children from
death. The commenter attributes this either to the closure apparently
being left off in one instance or to information being inconclusive in
the other scenarios. While it is unknown if child-resistant packaging
would have saved the lives of these children, the effectiveness of
child-resistant packaging in reducing deaths is well documented. For
prescription medicines and aspirin alone, CPSC estimates that the lives
of over 900 children have been saved since child-resistant packaging
was first required for these products. The commenter does not attempt
to refute that aspiration of mineral oil-based cosmetics may be
associated with serious injury. Requiring child-resistant packaging
would limit access to these products by children in the future.
Comment: One commenter (CP-01-3-4) provided a calculation of
relative risk and compared the risk of a baby oil fatality to the risk
of death by other products and the risk levels apparently used by the
Department of Defense and the Federal Aviation Administration.
Response: The PPPA requires that the Commission find: 1) that a
substance is capable of causing serious injury or illness to young
children that are exposed to it and 2) that CR packaging is technically
feasible, practicable, and appropriate. 15 U.S.C. 1472(a). The PPPA
does not require a relative risk evaluation as a prerequisite to
requiring CR packaging.
C. Additional Death
CPSC staff has become aware of an additional death resulting from
aspiration of baby oil (010628HAA3357). The victim's twin brother
opened the closed bottle of baby oil and gave it to the victim.
According to the mother, the child, a 15-16 month-old who had a history
of respiratory problems, then ingested baby oil. The child was admitted
to the hospital on the following day with breathing problems and died
29 days after the exposure. The death certificate lists respiratory
failure due to acute respiratory distress syndrome (ARDS) and oil
aspiration.
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D. The Scope of the Regulations
After reviewing the comments submitted in response to the NPR and
the supplemental notice of data availability, the Commission has
decided to issue final PPPA rules for household products that contain
hydrocarbon chemicals capable of causing chemical pneumonia and death
following aspiration. The remainder of this section describes the scope
and form of the final rules.
The rules apply 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 hydrocarbons in the
product is the sum of the percentages by weight of the individual
hydrocarbon components.
The final rules exclude aerosol products (i.e., pressurized spray
containers). The rules also exclude products packaged in mechanical
pumps and trigger sprayers, provided that the spray mechanism is either
permanently attached to the product container or has a child-resistant
attachment. Potential coverage of aerosols, pump and trigger sprayers
will be addressed separately in a future proceeding.
The definition of what is a ``household substance'' that can be
regulated under the PPPA includes, inter alia, 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). Enforcement of the PPPA with respect to hazardous substances is
accomplished using the misbranding and prohibited acts sections of the
FHSA. 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 discrete rules, one for
hazardous substances and one for drugs and cosmetics, to closely
associate a particular rule with the applicable enforcement mechanism.
Foods are not covered under the rules, because there currently are no
data indicating a need for CR packaging of food products.
Current FHSA regulations partially exempt small packages, minor
hazards, and certain 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 specifications listed in the regulations. These products
are also excluded from the child-resistant packaging requirements in
this final rule due to the difficulty a child would have in 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 also excluded from the child-resistant
packaging requirements of the final rules.
E. Statutory Considerations
1. Hazard to Children
Before issuing rules requiring CR packaging, the Commission must
find that the degree or nature of the hazard to children in the
availability of the products in question by reason of their packaging
is such that special packaging is required to protect children from
serious injury or illness from handling, using, or ingesting the
products. 15 U.S.C. 1472(a)(1). The Commission made these findings
preliminarily with regard to household chemicals and cosmetics in the
preambles to the ANPR and NPR for the rules that are being issued in
final form today.\2\ Subsequent CPSC staff review of additional data on
mineral oil-based cosmetics, as discussed above, validate that children
access these products and that those that contain 10 percent or more
hydrocarbons with viscosities under 100 SUS at 100 deg.F can result in
serious injury. In fact, it is worth noting that several brands of baby
oil, a product obviously intended for use on small children, are
labeled with a warning as follows:
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\2\ See 62 FR 8661-2 (February 26, 1997) and 65 FR 98-9 (January
3, 2000), which are hereby incorporated by reference.
It is also worth noting that the PPPA ``hazard to children''
finding with respect to these hydrocarbons has also been made as a
prerequisite to issuing the three current child-resistant packaging
regulations that address specific household products containing
hydrocarbons: 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).
For external use only. Keep out of children's reach to avoid
drinking and accidental inhalation, which can cause serious injury.
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Should breathing problems occur, consult a doctor immediately.
That warning is in effect the required PPPA statutory finding.
With respect to the general category of hydrocarbon-containing
products, Congress, in enacting the original PPPA in 1970, specifically
addressed the hazard of ingesting and aspirating hydrocarbon-containing
products as one of the fundamental bases of the need for the PPPA:
In the household specialties area, some chemicals cause serious
illness requiring lengthy hospitalization from which the child may
never recover. * * * On ingestion, these petroleum distillates
[hydrocarbons] are readily aspirated into the lungs and may lead to
severe chemical pneumonitis in a matter of minutes.
H.R. Rep. No. 91-1642 at 5 (1970)
For the foregoing reasons, the Commission finds that the degree or
nature of the hazard to children in the availability of products that
contain 10 percent or more hydrocarbons with viscosities under 100 SUS
at 100 deg.F, by reason of their packaging, is such that special
packaging is required to protect children from serious personal injury
or serious illness resulting from handling, using, or ingesting the
products.
2. Technical Feasibility, Practicability, and Appropriateness
As a prerequisite to CR packaging rules, the Commission must also
find that the special packaging is ``technically feasible, practicable,
and appropriate.'' 15 U.S.C. 1472(a)(2). Technical feasibility may be
found when technology exists or can be readily developed and
implemented by the effective date to produce packaging that conforms to
the standards. Practicability means that special 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. See S. Rep. No. 91-845, at 10 (1970).
The Commission made these findings preliminarily and issued the
proposed rules. Those findings, which appear at 65 FR 99-100, are
hereby incorporated by reference. No comments were received in response
to the NPR regarding the technical aspects of child-resistant
packaging. Therefore, the Commission concludes that CR packaging is
technically feasible, practicable, and appropriate for products that
contain 10 percent hydrocarbons or more by weight with a viscosity less
than 100 SUS at 100 deg.F.
3. Other Considerations
Section 3(b) of the PPPA requires that the Commission consider the
following in establishing special packaging standards:
[[Page 53956]]
a. The reasonableness of the standard;
b. Available scientific, medical, and engineering data concerning
special packaging and concerning childhood accidental ingestions,
illness, and injury caused by household substances;
c. The manufacturing practices of industries affected by the PPPA;
and
d. The nature and use of the household substance. 15 U.S.C.
1472(b).
The Commission has considered these factors with respect to the
various determinations made in this rulemaking, and finds no reason to
conclude that the rules are unreasonable or otherwise inappropriate.
F. Effective Date
The PPPA provides that no regulation shall take effect sooner than
180 days or later than one year after the date such final regulation is
issued, except that, for good cause, the Commission may establish an
earlier effective date if it determines an earlier date to be in the
public interest. 15 U.S.C. 1471n. The NPR proposed an effective date of
one (1) year after publication of the final rules.
Two comments received on the NPR requested additional time for
companies that may need it. However, no information was submitted to
demonstrate that more than one year would be necessary to adopt child-
resistant packaging for any product.
The CPSC staff estimated that any necessary packaging changes could
be achieved during a one-year time frame. Therefore, the Commission is
issuing these final rules with an effective date of one year after the
date of their publication in the Federal Register. The Commission is
not establishing a general procedure for stays of enforcement of the
requirements of these final rules. However, there is nothing to
preclude an individual company from requesting relief from the CPSC
Office of Compliance if specific difficulties arise in complying by the
effective date.
G. Regulatory Flexibility Act Certification
When an agency undertakes a rulemaking proceeding, the Regulatory
Flexibility Act (RFA), as amended by the Small Business Regulatory
Enforcement Fairness Act of 1996, 5 U.S.C. 601 et seq., generally
requires the agency to prepare initial and final regulatory flexibility
analyses describing the impact of the rule on small businesses and
other small entities. Section 605 of the RFA provides that an agency is
not required to prepare a regulatory flexibility analysis if the head
of the agency certifies that the rule will not have a significant
economic impact on a substantial number of small entities.
The Commission's Directorate for Economic Analysis prepared an
assessment of the impact of rules to require CR packaging for products
that contain 10 percent hydrocarbons or more by weight with a viscosity
less than 100 SUS at 100 deg.F. A copy of the assessment is available
for inspection in the docket for this rulemaking. The assessment
reports that the incremental cost of providing basic CR packaging is
usually small ($0.005-$0.02/per package), and confirms the staff's
previous experience with child-resistant packaging and current
packaging. Child-resistant packaging is widely available and the
incremental costs are small relative to the cost of most household
chemicals and cosmetic products. In addition, the one (1) year
effective date should include enough lead-time for companies to use up
existing package inventory.
Based on that assessment, the Commission certified in the NPR that
the rules, if promulgated as proposed, would not have a significant
economic effect on a substantial number of small entities.
The NPR was sent to 375 trade associations and companies believed
to make products that contain hydrocarbons. The Commission did not
receive any comments in response that questioned the certification.
Therefore, there is no evidence available that the rules would have a
significant economic impact on a substantial number of small entities.
Based on the foregoing analysis, the Commission certifies that
these final rules do not have a significant impact on a substantial
number of small businesses or other small entities.
H. Environmental Considerations
Pursuant to the National Environmental Policy Act, and in
accordance with Council on Environmental Quality regulations and CPSC
procedures for environmental review, the Commission has analyzed the
possible environmental effects associated with the proposed PPPA
requirements on products that contain 10 percent hydrocarbons or more
by weight and have a viscosity less than 100 SUS at 100 deg.F.
The Commission's regulations state that rules requiring special
packaging normally have little or no potential for affecting the human
environment. 16 CFR 1021.5(c)(3). Nothing in these rules alters that
expectation. Therefore, because the rules would have no adverse effect
on the environment, neither an environmental assessment nor an
environmental impact statement is required.
I. Executive Order No. 12988
As provided in Executive Order No. 12988 the CPSC states the
preemptive effect of these final rules as follows.
The PPPA provides that, generally, when a special packaging
standard issued under the PPPA is in effect, ``no State or political
subdivision thereof 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.'' 15 U.S.C. 1476(a). A State or local standard may be
excepted from this preemptive effect if (1) the State or local standard
provides a higher degree of protection from the risk of injury or
illness than the PPPA standard; and (2) the State or political
subdivision applies to the Commission for an exemption from the PPPA's
preemption clause and the Commission grants the exemption through
procedures specified at 16 CFR part 1061. 15 U.S.C. 1476(c)(1). In
addition, the Federal government, or a State or local government, may
establish and continue in effect a non-identical special packaging
requirement that provides a higher degree of protection than the PPPA
requirement for a household substance for the Federal, State or local
government's own use. 15 U.S.C. 1476(b).
Thus, with the exceptions noted above, these rules preempt non-
identical state or local special packaging standards for such drug
products.
List of Subjects in 16 CFR Part 1700
Consumer protection, Drugs, Infants and children, Packaging and
containers, Poison prevention, Reporting and record keeping
requirements.
For the reasons stated in the preamble, the Commission amends 16
CFR 1700.14(a) as follows.
PART 1700--POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS
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) (31) and (32) to read as
follows:
Sec. 1700.14 Substances requiring special packaging.
(a) * * *
[[Page 53957]]
(31) 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 contents is by a spray device (e.g., aerosols, or pump-or
trigger-actuated sprays where the pump or trigger mechanism has either
a child-resistant or permanent attachment to the package).
(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
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 hydrocarbons in the
product is the sum of the percentages by weight of the individual
hydrocarbon components.
(32) 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 where the pump or trigger mechanism has either
a child-resistant or permanent attachment to the package).
(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 hydrocarbons in the product is
the sum of the percentages by weight of the individual hydrocarbon
components.
* * * * *
Dated: October 19, 2001.
Todd A. Stevenson,
Acting Secretary, Consumer Product Safety Commission.
List of Relevant Documents
1. Briefing memorandum from Suzanne Barone, Ph.D., EH, to the
Commission, ``Final Rule to Require Special Packaging for
Hydrocarbons of Low Viscosity,'' September 12, 2001.
2. Memorandum from Robert L. Franklin, EC to Suzanne Barone,
Ph.D., EH, ``Economic Considerations Regarding the Final Rule to
Require CR Packaging for Products Containing Low Viscosity
Hydrocarbons,'' August 24, 2001.
3. ``Pediatric Potential Aspirations of Cosmetic Products: 1998
Data,'' C. Craig Morris, Ph.D., U.S. Consumer Product Safety
Commission, Directorate for Epidemiology, Division of Hazard
Analysis, March 2001.
4. ``Pediatric Hydrocarbon Exposures and Potential
Aspirations,'' C. Craig Morris, Ph.D., U.S. Consumer Product Safety
Commission, Directorate for Epidemiology, Division of Hazard
Analysis, February 2001.
[FR Doc. 01-26837 Filed 10-24-01; 8:45 am]
BILLING CODE 6355-01-P