[Federal Register Volume 66, Number 207 (Thursday, October 25, 2001)]
[Rules and Regulations]
[Pages 53951-53957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26837]


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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 [email protected], 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

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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

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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