[Federal Register Volume 63, Number 220 (Monday, November 16, 1998)]
[Rules and Regulations]
[Pages 63602-63608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29732]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ Numbers in parentheses refer to documents listed at the end
of this notice.
---------------------------------------------------------------------------
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