[Federal Register: February 19, 2002 (Volume 67, Number 33)]
[Proposed Rules]
[Page 7319-7321]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe02-20]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1700
Poison Prevention Packaging Requirements; Proposed Exemption of
Hormone Replacement Therapy Products
AGENCY: Consumer Product Safety Commission.
ACTION: Proposed rule.
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SUMMARY: The Commission is proposing to amend its child-resistant
packaging
[[Page 7320]]
requirements to exempt hormone replacement therapy (``HRT'') products
containing one or more progestogen or estrogen substances. Current
exemptions cover some HRT products, but not others. This proposal would
uniformly exempt all HRT products that rely solely on the activity of
one or more progestogen or estrogen substances from child resistant
packaging requirements.
DATES: Comments on the proposal should be submitted no later than May
6, 2002.
ADDRESSES: Comments should be mailed to the Office of the Secretary,
Consumer Product Safety Commission, Washington, DC 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. Comments should be
captioned ``Proposed HRT exemption.''
FOR FURTHER INFORMATION CONTACT: Jacqueline Ferrante, Ph.D., Division
of Health Sciences, Directorate for Epidemiology and Health Sciences,
Consumer Product Safety Commission, Washington, DC 20207; telephone
(301) 504-0477 ext. 1199.
SUPPLEMENTARY INFORMATION:
A. Background
The Poison Prevention Packaging Act of 1970 (``PPPA''), 15 U.S.C.
1471-1476, provides the Commission with authority to establish
standards for the special packaging of household substances, such as
drugs, when child resistant packaging is necessary to protect children
from serious personal injury or illness due to the substance and the
special packaging is technically feasible, practicable, and appropriate
for such substance. Accordingly, the Commission requires that oral
prescription drugs be in child resistant (``CR'') packaging. 16 CFR
1700.14(a)(10).
The Commission's regulations allow exemptions from this requirement
for substances with low acute toxicity. Currently, there are four PPPA
exemptions for sex hormones: (1) Oral contraceptives in mnemonic
packages containing one or more progestogen or estrogen substances; (2)
conjugated estrogen tablets in mnemonic packages; (3) norethindrone
acetate tablets in mnemonic packaging; and (4) medroxyprogesterone
acetate tablets. 16 CFR 1700.14(a)(10)(iv), (xvii), (xviii) and (xix).
Some HRT products fall within these exemptions, but because of the way
these exemptions are written, other HRT products currently require CR
packaging. The proposed exemption would cover all HRT products that
rely solely on the activity of one or more progestogen or estrogen
substances.
B. HRT Products
HRT is used to replace the estrogen and progesterone that normally
decline following menopause (the cessation of menstruation). Generally,
women experience a range of symptoms with some reporting minimal
discomfort, while others have more severe effects. Hot flashes are the
most frequent symptom and often begin several years before other
menopausal symptoms. Additionally, menopause accelerates bone depletion
that commonly occurs with aging, leading to osteoporosis.
HRT relieves a number of menopausal symptoms (e.g., hot flashes and
vaginitis) and helps to prevent osteoporosis. HRT consists of using
estrogen alone or various combinations of estrogens and progestins. The
latter regimen is similar to that for oral contraceptive products
except the goal of therapy is to replace declining hormone levels
rather than to prevent pregnancy.
Because the life expectancy of women in the United States is
increasing, it is estimated that 40 million women will go through
menopause in the next 20 years. Therefore, the pharmaceutical industry
is developing new prescription products specifically designed and
marketed for HRT post-menopausal women. Some of these products may not
be covered under current PPPA regulations although their toxicity is as
low as those products currently exempt.
Sex hormone products contain various estrogens and progestins. Some
are natural hormones (e.g., estradiol) and others are semi-synthetic or
synthetic (e.g., norgestimate). Synthetic hormones are usually
developed to alter bioavailability (e.g., enhance oral absorption) or
to reduce side effects. Since available HRT products contain similar
estrogen/progestin combinations, it is reasonable and consistent to
exempt them like oral contraceptives.
C. Toxicity Data
Human toxic doses for estrogens or progestins have not been
defined. Exposure summaries in the Poisindex for estrogens,
progestins, and oral contraceptives state that acute toxicity is
unlikely following overdosage. Gastrointestinal effects (e.g., nausea,
vomiting, abdominal cramps) may occur after an acute overdose, but
typically no treatment is necessary.
There is little information in the medical literature concerning
acute overdosage of progestins or estrogens. One case showed that a
single dose of 160 mg estradiol valerate (80 tablets/2 mg each),
ingested by a 19-year-old woman in a suicide attempt, produced little
toxicity. The woman slept easily during the night of the ingestion and
the next evening presented in the emergency clinic in generally good
condition with nausea and a headache.
Poisoning data from the American Association of Poison Control
Centers (``AAPCC'') Toxic Exposure Surveillance System (``TESS''),
corroborate the lack of acute toxicity associated with sex hormones.
The staff reviewed data showing acute exposures in children less than
five years old to estrogens, progestins, and oral contraceptives from
1993 to 1998. There were no deaths and most of the exposures were non-
toxic. There was one major outcome out of 37,645 exposures to oral
contraceptives, but no details are readily available relating to this
case. It is possible that this oral contraceptive formulation contained
iron or that the child was exposed to a second substance or product.
D. Impact on Small Business
The Commission's Directorate for Economic Analysis prepared a
preliminary assessment of the impact of a rule to exempt HRT products
from special packaging requirements. The staff reports that it does not
know the universe of companies that would be affected by the proposed
exemption or how many companies would be small businesses. However, the
exemption is not likely to have a significant impact on a substantial
number of companies, regardless of size. The exemption would actually
increase the packaging options for manufacturers because it would allow
them to package the affected HRT products in non-CR packages. Although
the cost to manufacturers of CR packaging is small--usually only a few
cents per package--the exemption would allow manufacturers to use
slightly cheaper packages and thus reduce the final cost of the HRT
products.
Based on this assessment, the Commission preliminarily concludes
that the proposed amendment exempting HRT products from special
packaging requirements would not have a significant impact on a
substantial number of small businesses or other small entities.
E. Environmental Considerations
Pursuant to the National Environmental Policy Act, and in
[[Page 7321]]
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
amendment.
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.
F. 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 exempting
HRT products from special packaging requirements would preempt non-
identical state or local special packaging standards for those
products.
The Commission has also evaluated the proposed rule in light of the
principles stated in Executive Order 13132 concerning federalism, even
though that Order does not apply to independent regulatory agencies
such as CPSC. The Commission does not expect that the proposed rule
will have any substantial direct effects on the States, the
relationship between the national government and the States, or the
distribution of power and responsibilities among various levels of
government.
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)(10)(xxi)
to read as follows (although unchanged, the introductory texts of
paragraph (a) and paragraph (10) are 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:
* * * * *
(10) Prescription drugs. Any drug for human use that is in a dosage
form intended for oral administration and that is required by Federal
law to be dispensed only by or upon an oral or written prescription of
a practitioner licensed by law to administer such drug shall be
packaged in accordance with the provisions of Sec. 1700.15 (a), (b),
and (c), except for the following:
* * * * *
(xxi) Hormone Replacement Therapy Products that rely solely upon
the activity of one or more progestogen or estrogen substances.
* * * * *
Dated: February 12, 2002.
Todd Stevenson,
Secretary, Consumer Product Safety Commission.
List of Relevant Documents
1. Briefing memorandum from Jacqueline Ferrante, Ph.D.,
Directorate for Health Sciences, to the Commission, ``Proposed Rule
to Exempt HRT Products from the Special Packaging Requirements of
the PPPA,'' January 14, 2002.
2. Memorandum from Robert Franklin, Directorate for Economic
Analysis, to Jacqueline Ferrante, Ph.D., Project Manager, ``Small
Business and Environmental Considerations Related to Exempting HRT
Products from PPPA Requirements,'' December 20, 2001.
[FR Doc. 02-3999 Filed 2-15-02; 8:45 am]
BILLING CODE 6355-01-P