[Federal Register Volume 63, Number 220 (Monday, November 16, 1998)]
[Rules and Regulations]
[Pages 63602-63608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29732]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


Final Rule: Requirements for Child-Resistant Packaging; Minoxidil 
Preparations With More Than 14 mg of Minoxidil Per Package

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: The Commission is issuing a rule to require child-resistant 
(``CR'') packaging for minoxidil preparations containing more than 14 
mg of minoxidil in a single package. The Commission has determined that 
child-resistant packaging is necessary to protect children under 5 
years of age from serious personal injury and serious illness resulting 
from handling or ingesting a toxic amount of minoxidil. The Commission 
takes this action under authority of the Poison Prevention Packaging 
Act of 1970.

DATES: Effective May 17, 1999. For metered finger mechanical sprayer 
applicators and extender attachments, this rule will not apply until 
November 16, 1999. This rule applies to preparations packaged on or 
after those dates.

FOR FURTHER INFORMATION CONTACT: Laura Washburn, Directorate for 
Compliance, Consumer Product Safety Commission, Washington, D.C. 20207; 
telephone (301) 504-0400 ext. 1452.

SUPPLEMENTARY INFORMATION:

A. Background

1. Relevant Statutory and Regulatory Provisions

    The Poison Prevention Packaging Act of 1970 (``PPPA''), 15 U.S.C. 
1471-1476, authorizes the Commission to establish standards for the 
``special packaging'' of any household substance if (1) the degree or 
nature of the hazard to children in the availability of such substance, 
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 and (2) the 
special packaging is technically feasible, practicable, and appropriate 
for the substance.\1\
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    \1\ Chairman Brown and Commissioner Moore voted to approve this 
notice. Commissioner Gall voted to approve the notice, except that 
she would have deferred action on metered finger sprayers and 
extender attachments.
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    Special packaging, also referred to as ``child-resistant'' (``CR'') 
packaging, is

[[Page 63603]]

(1) designed or constructed to be significantly difficult for children 
under 5 years of age to open or obtain a toxic or harmful amount of the 
substance contained therein within a reasonable time and (2) not 
difficult for ``normal adults'' to use properly. 15 U.S.C. 1471(4). 
Household substances for which the Commission may require CR packaging 
include (among other categories) foods, drugs, or cosmetics as these 
terms are defined in the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321). 15 U.S.C. 1471(2)(B). The Commission has performance 
requirements for special packaging. 16 CFR 1700.15, 1700.20.
    Section 4(a) of the PPPA, 15 U.S.C. 1473(a), allows the 
manufacturer or packer to package a nonprescription product subject to 
special packaging standards in one size of non-CR packaging only if the 
manufacturer (or packer) also supplies the substance in CR packages of 
a popular size, and the non-CR packages bear conspicuous labeling 
stating: ``This package for households without young children.'' 15 
U.S.C. 1473(a), 16 CFR 1700.5.

2. Minoxidil

    Topical minoxidil is a liquid medication applied to the scalp to 
stimulate hair regrowth for individuals with androgenetic alopecia, a 
common form of genetic hair loss. In February 1996, the Food and Drug 
Administration (``FDA'') approved the sale of topical minoxidil as an 
over-the-counter (``OTC'') drug available without a prescription. A 
tablet form of minoxidil is also available by prescription for 
treatment of severe hypertension. Like most oral prescription drugs, 
the prescription form of minoxidil must be in special packaging. 16 CFR 
1700.14(a)(10). However, special packaging is not required for topical 
drugs unless the Commission takes specific action to require it.
    Topical minoxidil first became available by prescription in 1988. 
The OTC preparation is currently marketed as a two percent solution in 
60 percent alcohol, propylene glycol, and water. The package 
instructions direct the user to apply one milliliter (20 milligrams of 
minoxidil) to the scalp twice a day. This application generally must 
continue for four months, and further application is necessary to 
maintain the newly grown hair. The most prevalent package size contains 
60 milliliters of the preparation (1200 milligrams of minoxidil) which 
is a 30-day supply if used as directed.(2) 2 On November 14, 
1997, the FDA approved for OTC use a 5% minoxidil solution for men. The 
package size is also 60 milliliters, and the recommended dosage is one 
milliliter (50 milligrams of minoxidil) applied twice a day. The total 
contents of this package is 3000 milligrams.
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    \2\ Numbers in parentheses refer to documents listed at the end 
of this notice.
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    The Commission is aware of ten manufacturers that have FDA's 
approval to market the OTC two percent minoxidil solution. In addition, 
the Commission knows of six other companies--probably repackagers or 
relabelers--that sell the OTC minoxidil formulation. The year after FDA 
approved OTC status for topical minoxidil preparations, retail sales of 
topical minoxidil were about $200 million (approximately 8 million 
packages). (3)
    Topical minoxidil formulations are generally packaged either for 
men or for women. The formulations are the same, but the packaging and 
instructions are different. All the bottles the Commission is aware of 
are secured with CR senior friendly (``SF'') continuous threaded 
closures. In addition to the primary closure, the packages the 
Commission staff examined contain one or more applicators that are 
reasonably expected to be used to replace the primary closure.
    The Commission staff examined nine topical minoxidil packages for 
men. These packages contained dropper applicators. In six of these, the 
droppers were CR/SF, the other three droppers were non-CR. Four of the 
packages for men also contained a metered finger mechanical sprayer 
applicator (hereafter referred to as a ``finger sprayer'') in addition 
to the dropper applicator. None of the finger sprayers are CR. (4 and 
8).
    Hair loss for women occurs as a thinning of the hair over a broad 
area on the top of the scalp rather than at the vertex. All four of the 
topical minoxidil packages for women that the staff examined contained 
the finger sprayer. Two products for women included a CR/SF dropper in 
addition to the finger sprayer. Three packages for women included an 
extender attachment to fit onto the finger sprayer applicator allowing 
the solution to be applied closer to the scalp than the finger sprayer 
alone would manage. Neither the finger sprayers nor the extenders in 
the packages intended for women were CR. (4 and 8).

3. CR Packaging for Applicators

    As explained in the notice of proposed rulemaking (``NPR'')(63 FR 
13019), because the topical minoxidil formulations are packaged with 
applicators that are reasonably expected to replace the primary closure 
of the product, the Commission has determined that the applicators 
themselves must be CR if the Commission requires CR packaging for the 
product.
    Under the PPPA, a ``package'' is defined as:

the immediate container or wrapping in which any household substance 
is contained for consumption, use, or storage by individuals in or 
about the household.

15 U.S.C. 1471(3). This definition focuses on how the product is 
packaged in the home where it is ``contained for consumption, use or 
storage'' rather than its packaging in the store. This is fully 
consistent with the purpose of the statute, to reduce child poisonings 
from available household substances.
    The exclusions from the definition of ``package'' also indicate 
that Congress was concerned with the package as maintained in the home. 
Congress excluded containers used only to transport the product. Id.
    The legislative history of the statute also supports the view that 
the ``package'' includes applicators that are reasonably expected to be 
used as closures in the home. The Senate Commerce Committee Report 
notes: ``The term `package' was defined here to [sic] in order to make 
explicit that special packaging refers to that package in which the 
substance is kept in or around the house.'' S. Rep. 845, 91st Cong., 2d 
Sess. 9 (1970).
    Thus, the Commission concludes that when an applicator is packaged 
with a product that requires CR packaging and the applicator is 
reasonably expected by the Commission to replace the original closure 
of the packaging, that applicator must also be CR. This does not mean 
that every applicator packaged with a substance requiring CR packaging 
must itself be CR. It is permissible for an applicator, such as a 
dropper, to be packaged with a product so long as the applicator cannot 
be used to replace the original closure. As discussed in the NPR, this 
view reflects the long held interpretation of the Commission staff. 63 
FR 13021.
    Because the Commission has not previously addressed this question 
explicitly in a regulation, the minoxidil rule expressly states that 
applicators packaged with topical minoxidil that are reasonably 
expected to replace the original closures would be required to be CR 
and SF. The Commission recognizes that its other rules, such as the 
rule covering oral prescription drugs or acetaminophen, do not contain 
such a provision. When previous special packaging rules were issued, 
few

[[Page 63604]]

packages contained applicators that could be used as closures. Thus, 
previous rules did not expressly state that such applicator closures 
are ``packages'' under the PPPA. In order to clarify the issue, the 
Commission is including such a statement in the minoxidil rule. The 
lack of such a statement in previous PPPA rules is not to be construed 
to mean applicator closures are exempt from special packaging 
requirements.
    The Commission did not receive any comments questioning its 
interpretation of the PPPA as covering applicators that are reasonably 
expected to be used to replace the primary closure.

4. The Proposed Rule

    On March 17, 1998, the Commission issued an NPR that proposed 
requiring CR packaging for minoxidil preparations containing more than 
14 mg of minoxidil in a single package. 63 FR 13019.
    The Commission received five comments in response to the proposed 
rule. The American Academy of Pediatrics commented in support of the 
rule and expressed agreement with the Commission's position that the CR 
packaging requirement should include applicators expected to replace 
original closures on minoxidil products. Other comments and the 
Commission's responses are discussed below.(7)
Packaging Issues
    Comment: One comment from the Closure Manufacturers Association 
(``CMA'') stated that the Commission had no data to demonstrate that CR 
extender finger sprayers are technically feasible and practicable. The 
commenter stated that the preamble in the NPR had stated that 
technology does not exist for the development or use of CR finger 
sprayers with extenders. The commenter concluded that therefore 
continuing with the proposed rule ``would be a violation of the [PPPA] 
statute and the Administrative Procedures [sic] Act.''
    Response: CMA apparently misunderstood the statement in the NPR 
which noted that CR extender sprayers are not currently on the market. 
The fact that a particular CR closure is not currently being marketed 
does not mean it is not technically feasible and practicable. As 
explained in section E.2. of the preamble, technical feasibility refers 
to the capability of producing a CR closure, not whether one is 
actually on the market. Similarly, practicability means that mass 
production methods can be used to produce CR packaging for the 
substance, not that it is currently being done. Neither CMA nor any 
other commenters have presented any information indicating that a CR 
extender sprayer could not be developed or could not be mass produced. 
In fact, as discussed below, some companies said they would need more 
time to produce CR applicators for minoxidil products, but they did not 
question their ability to make any of the available applicators CR.
    CMA's comments refer only to the extended sprayer. It is important 
to note that the PPPA does not require that every package design must 
be made CR. The Commission has no information indicating that a CR 
extended sprayer could not be made. However, even if it could not, 
other CR packaging applicators exist that are technically feasible, 
practicable and appropriate exist. Thus, this rulemaking does not 
violate the PPPA or any other statute.
    Comment: One commenter indicated that CR droppers are not a good 
barrier because children can chew through the bulb.
    Response: When testing CR dropper packaging, if a child chews 
through or pulls out the dropper bulb this would count as a failure 
since the child gains access to the product. The Commission's data 
indicate that dropper assemblies currently on the market pass the CR 
packaging test protocol and meet the requirements of the PPPA.
    Comment: The same commenter requested that the Commission prohibit 
applicators that could be used as substitutes for original closures 
because of cost, time, and potential competitive imbalance.
    Response: Under the PPPA, the Commission cannot prescribe specific 
packaging designs. 15 U.S.C. 1472(d). Thus, companies may use any 
packaging that meets the requirements of the special packaging 
protocol. Similarly, any applicator (if it is reasonably expected to 
replace the original closure) that meets these requirements could be 
used. Moreover, as pointed out in the proposed rule, an applicator that 
would not be used to replace the original closure, such as a dropper 
without a reclosable feature, would also be acceptable.
Effective Date for Finger Sprayers
    Comment: Three commenters indicated that the proposed effective 
date of one year was too short. One commenter requested a total of 34 
months (22 months in addition to a one year effective date). Another 
commenter stated that 27-36 months would be necessary to incorporate a 
CR finger sprayer.
    Response: After reviewing the process for commercialization of a CR 
finger sprayer, the Commission agrees that more than one year may well 
be necessary. Thus, the Commission will allow companies to request a 
stay of enforcement to provide additional time to produce CR finger 
sprayers and extender sprayers, and it would anticipate granting such 
requests until such time as it determined that an enforcement stay was 
no longer appropriate. This issue is discussed further in section F of 
the preamble.
Cost Considerations
    Comment: One commenter indicated that the additional cost of CR 
droppers instead of non-CR droppers was greater than $0.05 as suggested 
in the NPR.
    Response: The commenter has since indicated to CPSC staff that the 
$0.05 estimate is in fact within the range of increased cost for a CR 
dropper.
    Comment: One commenter stated that there would be a competitive 
disadvantage to generics if exclusive agreements for spray packaging 
were made with a brand product.
    Response: The commenter supplied no data and the Commission has no 
data to support this claim. In fact, two different companies commenting 
on the NPR provided information about the timing for developing a 
finger sprayer. Even if there were an exclusive agreement, it would not 
prevent other companies, such as the commenter from developing a CR 
finger sprayer independently. The estimated incremental cost of the CR 
sprayer will be a little more than double the 13-15 cents currently 
paid for the non-CR finger sprayer, according to one commenter. This is 
not a substantial cost increase relative to the product cost, even for 
less expensive generic minoxidil products. Moreover, several of the 
generic brands do not currently include a finger sprayer with their 
products. Also, a generic company is not necessarily a small company. 
The commenter, for example, is a large generic pharmaceutical 
manufacturer.

B. Toxicity of Minoxidil

    The Commission's Directorate for Epidemiology and Health Sciences 
reviewed the toxicity of minoxidil. Either as prescription tablets or a 
topical liquid, when it is ingested, minoxidil is rapidly and almost 
completely (over 95 percent) absorbed by the gastrointestinal tract and 
is distributed systematically throughout the body. Because minoxidil is 
very poorly absorbed through the skin, a topical solution of two 
percent minoxidil is considered safe when used on the skin as directed 
but can be harmful if ingested. (2)

[[Page 63605]]

    The tablet form of minoxidil is prescribed for use as an 
antihypertensive drug. It lowers blood pressure by relaxing the smooth 
muscle of the arteries. The body's nervous system responds by causing 
the heart to beat faster (tachycardia) and with more force (increased 
cardiac output) to compensate for the drop in blood pressure. (2)
    The most prominent effects from therapeutic ingestion of minoxidil 
are increased heart rate, increased cardiac output and decreased blood 
pressure. When blood pressure becomes abnormally low (hypotension), it 
can lead to lethargy and lightheadedness with the possibility of damage 
to the heart and other tissues with high oxygen demand, if left 
untreated. Less frequent effects include salt and fluid retention and 
edema, aggravation of angina, and pericardial effusion (massive fluid 
accumulation around the heart) in patients with renal impairment. 
Repeated ingestion over several months can produce hypertrichosis 
(overstimulated hair growth) particularly to the face and to a lesser 
extent to the limbs and scalp. Less severe symptoms of nausea, 
headache, fatigue, and dermatologic reactions have been occasionally 
reported. (2)
    Prescription minoxidil is available as 2.5 mg, 5 mg, and 10 mg 
tablets. The effective dosage is usually between 0.2 to 1 mg/kg/day 
(roughly 5 to 40 mg/day for an adult) depending on the individual and 
the desired antihypertensive response. Use in children has been limited 
with a similar effective body weight-normalized dose range as adults 
(0.2 to 1 mg/kg/day). Because of possible adverse effects, the maximum 
recommended daily therapeutic dosage is 100 mg in adults and 50 mg for 
children under the age of 12. (2)

C. Incident Data

    As discussed more extensively in the NPR, the staff reviewed 
several sources for information of adverse health effects from 
ingestions of minoxidil. These sources are the American Association of 
Poison Control Centers (``AAPCC''), the FDA Spontaneous Reporting 
System (``SRS''), published reports in the medical literature, and 
reports from the injury surveillance databases maintained by the 
Commission. The most commonly cited injuries are prolonged hypotension 
and tachycardia that require hospitalization. There were reports of two 
deaths associated with minoxidil overdose.
    AAPCC Data. The AAPCC collects reports made to participating poison 
control centers throughout the United States. A retrospective study by 
AAPCC evaluated AAPCC records of all minoxidil exposures from 1985 
through 1991. (The study did not distinguish between ingestions of 
minoxidil tablets and topical solution.) During this time period, 285 
incidents were reported. About half (51 percent) of these occurred in 
children under six years of age. (2)
    Annual AAPCC data on pediatric exposures to children under five 
years of age reported four accidental ingestions of topical minoxidil 
liquid in 1995, none of which led to serious toxicity. (Prior to 1995, 
topical minoxidil was not given a specific code within the AAPCC 
database.) In 1996, the number of reported cases increased to 43, one 
of these exhibited moderate effects. For 1997, the AAPCC had 52 reports 
of children under age five ingesting topical minoxidil. Half of these 
were referred to a health care facility for observation or treatment. 
However no serious outcomes were reported. (2 and 6)
    Because incidents involving minoxidil tablets (rather than topical 
solutions) are coded in a category that includes ``other 
vasodilators,'' it is not possible to isolate incidents specific to 
minoxidil tablets. There were two childhood ingestions of ``other 
vasodilators'' reported in 1995 that resulted in a moderate toxicity. 
(2)

FDA/SRS Database

    The SRS is a database maintained by the FDA for reports of adverse 
reactions detected after a drug goes on the market. Drug manufacturers 
are required to report any known incidents of adverse effects 
associated with their products. However, the incident reports are not 
verified by the FDA, and therefore, the adverse effects may reflect 
underlying diseases or reactions to multiple drugs.
    There have been 16,795 SRS reports on topical minoxidil between 
1983 and March 1997. Most of the reported adverse effects were dermal 
reactions to excessive application of topical minoxidil to the scalp. 
However, FDA specifically cited five overdose ingestion cases involving 
topical minoxidil. As discussed in more detail in the NPR, three of 
these led to serious outcomes. (2)

CPSC Databases

    CPSC has several databases for poison incidents. The staff reviewed 
cases from 1988 to June 1998 in the National Electronic Injury 
Surveillance System (``NEISS''). NEISS monitors emergency room visits 
to a statistically-based sample of selected hospitals throughout the 
United States. Three childhood poisoning cases associated with 
minoxidil were reported in the NEISS database during that time period. 
One was an ingestion of an unknown quantity of topical minoxidil by a 
two-year-old male. The child was seen in an emergency room with normal 
temperature, pulse, and respiration and was released the same day 
without treatment. It is not known whether the minoxidil package was 
secured with a child-resistant closure at the time of the incident. (2)
    There is less information concerning the two more recent incidents 
that were reported since the NPR. One case involved minoxidil tablets 
and the other resulted from topical minoxidil in a spray bottle. 
Neither child was hospitalized. No other details are available at this 
time. (6)
    The staff also reviewed CPSC's Injury and Potential Injury Incident 
(``IPII'') files of consumer product-related incidents reported through 
letters, telephone calls, media articles and death certificate files of 
consumer product-related deaths. There were no minoxidil-related 
injuries or deaths found in these databases for the 1988 to June 1998 
time period. (2)

Medical Literature

    Five case reports of injuries following minoxidil ingestion were 
found in the published literature. Two cases involved young children. 
In one instance, a two-year-old ingested an unconfirmed number of 
minoxidil tablets. In the second instance, a three-year-old swallowed 
an estimated 1-2 milliliters of three percent minoxidil solution (30-60 
milligrams). Both children were seen at hospitals experiencing moderate 
tachycardia but no other reported abnormalities. The three other 
reports were intentional ingestions by adults of minoxidil tablets (one 
case) or two percent liquid (two cases) and were discussed in the NPR. 
(2)

D. Level for Regulation

    The Commission is issuing a rule requiring special packaging for 
minoxidil products containing more than 14 mg of minoxidil in a single 
package. This is based on the maximum recommended therapeutic dose of 
minoxidil for an adult. The 14 mg dose level corresponds to 1.4 mg/kg 
for a 10 kg child. The equivalent minoxidil dose for the average 70 kg 
adult would be approximately 100 mg. The regulated dose level is 
expected to reasonably protect children under five years of age from 
serious personal injury or illness. (2) The Commission proposed this 
level and received no comments on it.

[[Page 63606]]

E. Statutory Considerations

1. Hazard to Children

    As noted above, the toxicity data concerning ingestion of minoxidil 
demonstrate that minoxidil can cause serious illness and injury to 
children. Moreover, it is available to children in OTC topical 
minoxidil preparations. Although as far as the Commission is aware, all 
primary product containers for topical minoxidil products currently use 
CR packaging, all applicators are not CR. Some packages contain 
applicators that are reasonably expected to be used as closures after 
first use which are not CR. The Commission concludes that a regulation 
is needed to ensure that products subject to the regulation, including 
applicators which it is reasonable to expect may be used to replace the 
original closures, will be placed in CR packaging by any current as 
well as future manufacturers.
    Pursuant to section 3(a) of the PPPA, 15 U.S.C. 1472(a), the 
Commission finds that the degree and nature of the hazard to children 
from handling or ingesting minoxidil is such that special packaging is 
required to protect children from serious illness. The Commission bases 
this finding on the toxic nature of minoxidil products and their 
accessibility to children in the home.

2. Technical Feasibility, Practicability, and Appropriateness

    In issuing a standard for special packaging under the PPPA, the 
Commission is required to 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, 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.
a. Primary Product Containers
    The primary product containers for all topical minoxidil products 
that the Commission is aware of have continuous threaded reclosable 
packaging. All of these closures that the staff examined were CR and 
SF. Thus, it is clear that CR packaging for primary product containers 
is technically feasible, practicable and appropriate. (4 and 8)
b. Applicators
    As discussed above, topical minoxidil packages contain 
applicators--droppers and/or metered finger mechanical sprayers--which 
it is reasonable to expect may replace the original closures. Eight 
products have droppers that are CR and SF. This indicates that such 
droppers are technically feasible, practicable and appropriate. (4 and 
8)
    The Commission knows of eight minoxidil products that include a 
non-CR finger sprayer. Child-resistance for a finger sprayer means that 
it must be significantly difficult for children to obtain an amount 
above the regulated level by, for example, (1) removing the finger 
sprayer closure from the container or (2) activating the finger sprayer 
mechanism. One packaging manufacturer has developed a prototype CR 
finger sprayer applicator which the manufacturer believes can be 
modified to pass senior adult effectiveness testing. In addition, two 
product manufacturers commenting on the NPR indicated that they could 
develop a finger sprayer that would meet special packaging 
requirements. As discussed above, an applicator that cannot be used as 
a closure does not need to be CR. (4 and 8)
    Three products for women also contain an extender to be used with 
the finger sprayer. Under the proposed rule, when the extender is 
attached to the finger sprayer, this applicator mechanism must be CR. 
That is, it must be significantly difficult for children to (1) remove 
the combined finger sprayer and extender from the container, (2) 
activate the combined finger sprayer and extender to obtain an amount 
above the regulated level, and (3) remove the extender. Currently no 
finger sprayers with extenders are CR. As noted above, CR/SF finger 
sprayer could be developed. Some modifications to the extender may be 
needed so that it would operate with the CR finger sprayer. (4 and 8)
    As discussed above, the Commission received one comment from CMA 
questioning whether an extender sprayer was feasible and practicable. 
However, since the finger sprayer and the extender use essentially the 
same mechanism, the Commission believes that the extender sprayer could 
be made CR/SF. The Commission is not aware of any data indicating 
otherwise.

3. Other Considerations

    In establishing a special packaging standard under the PPPA, the 
Commission must consider the following:
    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 notice, and finds no reason to 
conclude that the rule is 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 from 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.
    Primary closures and droppers. Primary product containers for 
topical minoxidil are already CR and SF. Droppers are available CR and 
SF that can be used to replace the original closures. Thus, the 
Commission proposed that a final rule with respect to child-resistance 
of primary closures and dropper applicators would take effect six 
months after publication of the final rule. The Commission has no 
additional information that would change this aspect of the proposed 
effective date.
    Finger sprayer and extender. The Commission stated in the NPR that 
it was aware of one packaging manufacturer that had developed a 
prototype CR finger sprayer that the manufacturer believed could be 
modified to pass senior adult effectiveness testing in approximately 12 
months. The Commission also recognized that additional time might be 
needed to provide commercial quantities of this type of packaging. 
Thus, the Commission proposed an effective date with respect to metered 
finger sprayer applicators and extenders that would be 12 months after 
publication of the final rule. The Commission also proposed that if 
additional time appeared necessary to produce commercial quantities of 
these applicators, manufacturers could request a temporary stay of 
enforcement for the finger sprayer and extender.
    As discussed above, the Commission received comments indicating 
that more than 12 months would be necessary to convert to a CR metered 
finger sprayer. Two commenters indicated that a design could be 
modified, tested, and in commercial use in approximately 27 to

[[Page 63607]]

36 months. The Commission agrees that this time seems reasonable due to 
the complexity of developing a finger sprayer that is metered and has 
two CR features. Because companies will need to commit resources to 
develop this type of packaging, companies may request a stay of 
enforcement immediately after this final rule is published, and the 
Commission would anticipate granting such requests until such time as 
it determined that an enforcement stay were no longer appropriate. 
Companies requesting a stay of enforcement should provide the 
Commission with a timeline or schedule that will outline the steps they 
will take to bring this type of CR packaging to commercial use. They 
should include an estimated initial production date and current and 
proposed packaging specifications.

G. Regulatory Flexibility Act Certification

    When an agency undertakes a rulemaking proceeding, the Regulatory 
Flexibility Act, 5 U.S.C. 601 et seq., generally requires the agency to 
prepare proposed and final regulatory flexibility analyses describing 
the impact of the rule on small businesses and other small entities. 
Section 605 of the Act provides that an agency is not required to 
prepare a regulatory flexibility analysis if the head of an agency 
certifies that the rule will not have a significant economic impact on 
a substantial number of small entities.
    As noted in the NPR, the Commission's Directorate for Economic 
Analysis prepared a preliminary assessment of the impact of a rule to 
require special packaging for topical minoxidil products containing 
more than 14 mg of minoxidil in a single package. Based on this 
assessment, the Commission concluded that the proposed requirement for 
minoxidil products would not have a significant impact on a substantial 
number of small businesses or other small entities. The Commission 
requested additional information on the possible impact on small 
business, but received no such comments. One commenter (not a small 
business) supplied cost estimates for the CR finger sprayer. The 
expected cost is not substantial relative to the retail cost of the 
product. Moreover, the Commission is unaware of any small firms that 
supply a finger sprayer with their product. Thus, the Commission 
continues to conclude that the rule would not have a significant effect 
on a substantial number of small entities.

H. Environmental Considerations

    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 assessed 
the possible environmental effects associated with the proposed PPPA 
requirements for minoxidil-containing products.
    In the NPR, the Commission concluded that the rule would have no 
adverse effect on the environment and that neither an environmental 
assessment nor an environmental impact statement is required. The 
Commission has no information that would alter this conclusion.

I. Executive Orders

    According to Executive Order 12988 (February 5, 1996), agencies 
must state in clear language the preemptive effect, if any, of new 
regulations.
    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). Upon application to the Commission, a 
State or local standard may be excepted from this preemptive effect if 
the State or local standard (1) provides a higher degree of protection 
from the risk of injury or illness than the PPPA standard and (2) does 
not unduly burden interstate commerce. 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, the rule requiring CR 
packaging for products containing more than 14 mg minoxidil would 
preempt non-identical state or local special packaging standards for 
such minoxidil containing products.
    In accordance with Executive Order 12612 (October 26, 1987), the 
Commission certifies that the rule does not have sufficient 
implications for federalism to warrant a Federalism Assessment.

List of Subjects in 16 CFR Part 1700

    Consumer protection, Drugs, Infants and children, Packaging and 
containers, Poison prevention, Toxic substances.
    For the reasons given above, the Commission amends 16 CFR part 1700 
as follows:

PART 1700--[AMENDED]

    1. The authority citation for part 1700 continues to read as 
follows:

    Authority: Pub. L. 91-601, secs. 1-9, 84 Stat. 1670-74, 15 
U.S.C. 1471-76. Secs 1700.1 and 1700.14 also issued under Pub. L. 
92-573, sec. 30(a), 88 Stat. 1231, 15 U.S.C. 2079(a).

    2. Section 1700.14 is amended by adding new paragraph (a)(28) to 
read as follows (although unchanged, the introductory text of paragraph 
(a) is included below for context):


Sec. 1700.14  Substances requiring special packaging.

    (a) Substances. The Commission has determined that the degree or 
nature of the hazard to children in the availability of the following 
substances, by reason of their packaging, is such that special 
packaging meeting the requirements of Sec. 1700.20(a) is required to 
protect children from serious personal injury or serious illness 
resulting from handling, using, or ingesting such substances, and the 
special packaging herein required is technically feasible, practicable, 
and appropriate for these substances:
* * * * *
    (28) Minoxidil. Minoxidil preparations for human use and containing 
more than 14 mg of minoxidil in a single retail package shall be 
packaged in accordance with the provisions of Sec. 1700.15(a), (b) and 
(c). Any applicator packaged with the minoxidil preparation and which 
it is reasonable to expect may be used to replace the original closure 
shall also comply with the provisions of Sec. 1700.15(a), (b) and (c).
* * * * *
    Dated: October 30, 1998.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.

List of Relevant Documents

    1. Briefing memorandum from Val Schaeffer, Ph.D., EH, to the 
Commission, ``Proposed Rule to Require Child-Resistant Packaging for 
Topical Minoxidil,'' February 10, 1998.
    2. Memorandum from Val Schaeffer, Ph.D., EH, to Marilyn Wind, 
Ph.D., Director, Health Sciences Division, ``Toxicity Assessment of 
Topical Minoxidil'' November 14, 1997.
    3. Memorandum from Marcia P. Robins, EC, to Val Schaeffer, 
Ph.D., EH, ``Economic Considerations of a Proposal to Require Child-
Resistant Packaging for Drug Preparations Containing Minoxidil,'' 
January 5, 1998.
    4. Memorandum from Charles Wilbur, EH, to Val Schaeffer, Ph.D., 
EH, ``Technical

[[Page 63608]]

Feasibility, Practicability, and Appropriateness Determination for 
the Proposed Rule to Require Special Packaging for Products 
Containing Minoxidil,'' December 16, 1997.
    5. Memorandum from Michael T. Bogumill, CRM, to Val Schaeffer, 
Ph.D., EH, ``Special Packaging of Oral Prescription Drugs in Dropper 
Bottles,'' December 17, 1997.
    6. Briefing memorandum from Suzanne Barone, Ph.D., EH, to the 
Commission, ``Final Rule to Require Child-Resistant Packaging for 
Topical Minoxidil,'' October 9, 1998.
    7. Memorandum from Martha A. Kosh, OS, Comments on the Proposed 
Rule for Requirements for Child-resistant Packaging; Minoxidil 
Preparation with More than 14 mg of Minoxidil per Package (CP98-3), 
June 2, 1998.
    8. Memorandum from Charles Wilbur, EH, to Suzanne Barone, Ph.D., 
EH, ``Technical Feasibility, Practicability, and Appropriateness 
Determination for the Final Rule to Require Special Packaging for 
Products Containing Minoxidil,'' August 21, 1998.
    9. Memorandum from Marcia P. Robins, EC, to Suzanne Barone, 
Ph.D., EH, ``Child-Resistant Packaging for Preparations Containing 
Minoxidil: Small Business Effects,'' August 24, 1998.

[FR Doc. 98-29732 Filed 11-13-98; 8:45 am]
BILLING CODE 6355-01-P