[Federal Register Volume 63, Number 51 (Tuesday, March 17, 1998)]
[Proposed Rules]
[Pages 13019-13025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6773]


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

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


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

AGENCY: Consumer Product Safety Commission.

ACTION: Proposed rule.

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

SUMMARY: The Commission is proposing 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 preliminarily 
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

[[Page 13020]]

ingesting a toxic amount of minoxidil. The Commission takes this action 
under the authority of the Poison Prevention Packaging Act of 1970.

DATES: Comments on the proposal should be submitted no later than June 
1, 1998.

ADDRESSES: Comments should be mailed to the Office of the Secretary, 
Consumer Product Safety Commission, Washington, D.C. 20207, or 
delivered to the Office of the Secretary, Consumer Product Safety 
Commission, Room 502, 4330 East-West Highway, Bethesda, Maryland 20814-
4408, telephone (301) 504-0800. Comments may also be filed by 
telefacsimile to (301) 504-0127 or by email to [email protected].

FOR FURTHER INFORMATION CONTACT: Suzanne Barone, Ph.D., Division of 
Health Sciences, Directorate for Epidemiology and Health Sciences, 
Consumer Product Safety Commission, Washington, D.C. 20207; telephone 
(301) 504-0477 ext. 1196.

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 such substance.
    Special packaging, also referred to as ``child-resistant'' (``CR'') 
packaging, is (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. Under 
these requirements, most special packaging must be child-resistant (85 
percent of a panel of 200 children cannot open it without a 
demonstration and 80 percent cannot open it with a demonstration) and 
senior-friendly (``SF'') (90 percent of a panel of 100 adults ages 50 
to 70 must be able to open the packaging in a 5 minute test period and 
open and (if appropriate) properly resecure it in a 1 minute test). 16 
CFR 1700.20(a)(2) and (3).
    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 that is applied to the 
scalp to stimulate hair regrowth for individuals with a common form of 
genetic hair loss (androgenetic alopecia). 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. There is also a tablet form of minoxidil for treatment of 
severe hypertension that is available only by prescription. 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 for there to be any noticeable hair growth. 
Continuous 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) 1 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 
the package is 3000 milligrams.
---------------------------------------------------------------------------

    \1\ Numbers in parentheses refer to documents listed at the end 
of this document.
---------------------------------------------------------------------------

    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. Although the formulations are the same, the packaging 
and instructions are different. All the bottles the Commission is aware 
of are secured with CR/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 once the product has been used for the 
first time.
    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. The finger sprayer releases the solution in 
a mist which the package insert claims may be more useful than a 
dropper for broader areas of hair loss. None of the finger sprayers are 
CR.(4)
    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 metered finger mechanical sprayer applicator. 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 pump spray alone would manage. Neither the finger 
sprayers nor the extenders in the packages intended for women were 
CR.(4)

3. CR Packaging for Applicators

    Because the topical minoxidil formulations are packaged with 
applicators that are reasonably expected to replace the primary closure 
of the product after its first use, the question

[[Page 13021]]

arises whether the applicators themselves must be CR if the Commission 
requires CR packaging for the product. The Commission has not 
previously addressed this issue.
    Under the PPPA, a ``package'' is the ``immediate container'' that 
holds a substance when it is located in the household. Specifically, 
the term ``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). The focus of this definition is 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. Thus, 
``package'' does not include:

    (A) any shipping container or wrapping used solely for the 
transportation of any household substance in bulk or in quantity to 
manufacturers, packers, or processors, or to wholesale or retail 
distributors thereof, or
    (B) any shipping container or outer wrapping used by retailers 
to ship or deliver any household substance to consumers unless it is 
the only such container or wrapping.

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 believes that when an applicator is packaged 
with a product that requires CR packaging and the applicator is 
reasonably expected 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.
    Early in the Commission's administration of the PPPA, the staff 
recognized the potential problem posed by applicators used to replace 
original closures. Accordingly, the staff advised that dropper bottles 
are not excepted from the PPPA's requirements. In 1974, the staff 
advised the Arizona State Board of Pharmacy that if a manufacturer of 
prescription drugs dispensed with droppers could not provide CR 
closures incorporating the dropper, the drug could be packaged with a 
conventional CR closure accompanied by a separate non-closing dropper. 
(See letter to Alfred J. Duncan, Executive Secretary of the Arizona 
State Board of Pharmacy from Robert Poth, April 11, 1974.) This 
position was reiterated in an internal staff memorandum stating ``when 
a prescription drug is packaged in a dropper bottle, it is the dropper 
bottle that is the `package' and any packaging exterior to this cannot 
be considered the `package.' '' The memo continues: ``[U]ntil special 
packaging is available for the dropper unit itself, manufacturers 
should place the drug in a specially packaged bottle, with a separate 
dropper provided for proper administration of the drug. However, in our 
view, the separately provided dropper should not contain a cap, since 
the consumer would be apt to use the dropper and noncomplying cap 
permanently, and discard the special cap.'' (Memo from Poth and 
Lemberg, June 12, 1974.) The staff discussed this position with staff 
at the FDA a few months later. The FDA staff agreed with the Commission 
staff's approach. (Memorandum of meeting between FDA and CPSC 
representatives, October 15, 1974.)
    Because the Commission has not previously addressed this question 
explicitly in a regulation, the proposed rule that the Commission 
issues today 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, do not 
contain such a provision. When previous special packaging rules were 
issued, few 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 proposes to include such a statement 
in the proposed rule for minoxidil. 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. As stated above, the 
Commission agrees with the staff's longstanding interpretation that 
special packaging requirements extend to applicators reasonably 
expected to replace primary closures when used and stored in the home.

B. Toxicity of Minoxidil

    The Commission's Directorate for Epidemiology and Health Sciences 
reviewed the toxicity of minoxidil. This includes both information 
concerning the therapeutic ingestion of prescription minoxidil tablets 
to treat hypertension and ingestion of topical minoxidil. In either 
form, 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. In contrast, minoxidil 
is very poorly absorbed through the skin, and insufficient levels of 
minoxidil reach the bloodstream to cause effects on vascular and 
cardiac function. This is why a topical solution of two percent 
minoxidil is considered safe when used on the skin as directed but can 
be harmful if ingested.(2)
    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. Minoxidil 
tablets are typically used in combination with a -adrenergic 
blocking agent and a diuretic to maximize its effect on blood pressure 
while minimizing associated side effects (the cardiac response and 
retention of fluids).(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)

[[Page 13022]]

    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

    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 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. Most of the 285 incidents were reportedly accidental 
ingestions (80%) and some involved co-ingestions (21%) of other 
substances. The most frequently reported adverse effects from 16 
incidents involving moderate to severe poisoning were hypotension 
(69%), tachycardia (38%), and lethargy (31%) with 44% requiring medical 
treatment. Most of the more serious poisonings were intentional 
ingestions (69%) and involved co-ingestions (81%). It was not reported 
how many of these incidents occurred in children. There was one 
reported death caused by an intentional ingestion of minoxidil with 
other vasodilators, and acetaminophen.(2)
    CPSC obtains annual AAPCC data on pediatric exposures to children 
under six years of age. Four accidental ingestions of topical minoxidil 
liquid were reported in 1995. (Prior to 1995, topical minoxidil was not 
given a specific code within the AAPCC database.) None of these four 
incidents led to serious toxicity. In 1996, the number of reported 
cases increased to 43. One of these exhibited moderate effects.
    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. Three of these led to serious outcomes.(2)
    One of these cases was a suicide in which an adult male ingested 
the contents of five bottles (6 grams in 300 ml) of topical minoxidil 
and died. No other details were provided. A second case was an adult 
male who mistakenly ingested 15-20 ml (300--400 mg) of topical 
minoxidil and experienced fainting, severe hypotension, cardiac 
effects, and acute renal failure. The person was taking anti-
hypertensive medication at the time of the poisoning but no other 
details of his prior medical condition were cited. The third case was 
an ingestion of topical minoxidil by a two-year-old child. She was 
found with an empty bottle that had been full earlier. She was admitted 
to an intensive care unit in a lethargic state with a pulse of 160 
(above normal range), blood pressure of 106/60 (within normal limits), 
but was discharged the same day. The amount of minoxidil actually 
ingested was never established.(2)
    In addition, two possible childhood ingestions of topical minoxidil 
were reported in SRS to result in hospital visits. In both incidents, 
no adverse outcomes were recorded but the children were retained at the 
hospital for observation. While the children gained access to the 
medication in these cases, the hospital suspected that no minoxidil was 
consumed.(2)

CPSC Databases

    CPSC has several databases for poison incidents. The staff reviewed 
cases from 1988 to 1997 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. One childhood poisoning case associated with minoxidil was 
reported in the NEISS database during that time period. This 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)
    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 1997 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). The latter two cases involved 
consumption of several hundred milligrams of minoxidil (10-20 mg/kg) 
along with alcohol and, in one case, several other substances. The 
clinical courses were similar. A few hours after ingestion, each 
individual was admitted to a hospital, usually in a disoriented and 
unresponsive state. They became moderately to severely hypotensive with 
tachycardia and elevated cardiac output. Medical treatment was 
administered and the patient's cardiac and vascular signs eventually 
normalized over the next 36 to 72 hours. In each instance, it was 
concluded that minoxidil was

[[Page 13023]]

primarily responsible for the observed effects, and that co-ingested 
substances were not consumed in amounts sufficient to cause the 
reported symptoms.(2)

D. Level for Regulation

    The Commission is proposing a rule that would require 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)

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 meant to be used as closures after first use which are not 
CR. The Commission preliminarily 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 new manufacturers.
    Pursuant to section 3(a) of the PPPA, 15 U.S.C. 1472(a), the 
Commission preliminarily 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 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.
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)
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)
    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 (1) remove the 
finger sprayer closure from the container and (2) activate the finger 
sprayer mechanism to obtain an amount above the regulated level. One 
packaging manufacturer has developed a prototype CR metered finger 
sprayer applicator which the manufacturer believes can be modified to 
pass senior adult effectiveness testing in approximately 12 months. 
Additional time may be required to provide commercial quantities of 
this type of packaging. As discussed above, an applicator that cannot 
be used as a closure does not need to be CR.(4)
    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 and (2) 
activate the combined finger sprayer and extender to obtain an amount 
above the regulated level. Currently no finger sprayers with extenders 
are CR. As noted above, CR/SF finger sprayer could be developed within 
12 months. Some modifications to the extender may be needed so that it 
would operate with the CR finger sprayer.(4)
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 preliminarily 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.
    Senior-friendly special packaging is currently commercially 
available for most types of CR packaging. Primary product containers 
for topical minoxidil are already CR and SF. Most droppers that can be 
used to replace the original closures are also CR and SF. One packaging 
manufacturer has developed a prototype CR finger sprayer that the 
manufacturer believes can be modified to pass senior adult 
effectiveness testing in approximately 12 months. Additional time may 
be required to provide commercial quantities of this type of packaging. 
Modifications to the extender would likely require a similar amount of 
time. Thus, the Commission proposes that a final rule would take effect 
(1) six months after publication of the final rule for primary closures 
and dropper applicators and (2) 12 months after publication of the 
final rule for metered finger sprayer applicators and extenders. The 
Commission also proposes that if additional time is necessary to 
produce commercial quantities, manufacturers could request a temporary 
stay of enforcement for the finger sprayer and extender. A final rule 
would apply to products that are packaged on or after the effective 
date.

[[Page 13024]]

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.
    The Commission's Directorate for Economic Analysis prepared a 
preliminary assessment of the impact of a rule to require special 
packaging topical minoxidil products containing more than 14 mg of 
minoxidil in a single package.
    This assessment reports that the staff is aware of 16 marketers of 
minoxidil-containing products. Ten of these are manufacturers, and two 
of the ten are small companies.(3)
    As mentioned above, at the present time, the primary packaging for 
all topical minoxidil products is CR. Thus, there will be no additional 
cost to existing firms to use CR primary packaging. Firms entering the 
market in the future will find readily available CR primary packaging 
at prices competitive with non-CR packaging.(3)
    Similarly, companies now using CR dropper applicators that can be 
used as closures will not incur any additional cost. For other 
companies to switch from non-CR droppers, there is an estimated 5 cent 
incremental cost of a CR dropper compared with a non-CR dropper. This 
cost is small relative to the retail price of a minoxidil product ($6-
$30).(3)
    Because there are no CR metered finger mechanical sprayer 
applicators or extenders currently on the market, the staff has no 
information on the incremental cost of senior friendly CR finger 
sprayers and extenders.(3) Firms do have the option of supplying only a 
CR/SF dropper applicator. They also could supply any type of applicator 
that cannot be used as a closure.
    Based on this assessment, the Commission preliminarily concludes 
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 seeks additional information on the 
possible impact on small business.

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.
    The Commission's regulations state that rules requiring special 
packaging for consumer products normally have little or no potential 
for affecting the human environment. 16 CFR 1021.5(c)(3). Nothing in 
this proposed rule alters that expectation.(3) Therefore, because the 
rule would have no adverse effect on the environment, neither an 
environmental assessment nor an environmental impact statement is 
required.

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). 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 a 
process 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, the proposed 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 proposed rule does not have sufficient 
implications for federalism to warrant a Federalism Assessment.

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 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.

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 proposes to amend 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 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

[[Page 13025]]

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: March 11, 1998.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 98-6773 Filed 3-16-98; 8:45 am]
BILLING CODE 6355-01-P