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

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.

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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.

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\1\ Numbers in parentheses refer to documents listed at the end

of this document.

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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. 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