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

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