[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]
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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 cpsc-os@cpsc.gov.
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
