[Federal Register Volume 67, Number 212 (Friday, November 1, 2002)]
[Rules and Regulations]
[Pages 66550-66552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27745]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1700
Poison Prevention Packaging Requirements; Exemption of Hormone
Replacement Therapy Products
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
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SUMMARY: The Commission is amending its child-resistant packaging
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 rule would
uniformly exempt from child resistant packaging requirements all HRT
products that rely solely on the activity of one or more progestogen or
estrogen substances.
[[Page 66551]]
DATES: The rule is effective November 1, 2002, and applies to products
packaged on or after that date.
FOR FURTHER INFORMATION CONTACT: Geri Smith, Office of Compliance and
Enforcement, Consumer Product Safety Commission, Washington, DC 20207;
telephone (301) 504-0608 ext. 1160.
SUPPLEMENTARY INFORMATION:
A. Background
The Poison Prevention Packaging Act of 1970 (``PPPA''), 15 U.S.C.
1471-1476, authorizes the Commission to issue standards for the special
packaging of household substances, such as drugs, when (1) Child
resistant packaging is necessary to protect children from serious
personal injury or illness due to the substance and (2) the special
packaging is technically feasible, practicable, and appropriate for the
substance. Accordingly, a Commission rule 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 that have low acute toxicity. 16 CFR 1702.1(b) and
1702.7. Current regulations provide 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.
On February 19, 2002, the Commission published a notice of proposed
rulemaking (``NPR'') proposing to exempt from the special packaging
requirements HRT products containing one or more progestogen or
estrogen substances. 67 FR 7319. This rule will make the exemption of
HRT products more uniform by exempting all HRT products that rely
solely on the activity of one or more progestogen or estrogen
substances.\1\
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\1\ Commissioner Thomas H. Moore issued a statement, which is on
file in the Commission's Office of the Secretary, Room 501, 4330
East-West Highway, Bethesda, Maryland 20814.
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B. HRT Products
HRT is used to replace the estrogen and progesterone that normally
decline following menopause (the cessation of menstruation). Women may
experience a range of menopausal symptoms. Additionally, menopause
accelerates bone depletion that commonly occurs with aging, leading to
osteoporosis.
HRT has been used to relieve a number of menopausal symptoms and
help to prevent osteoporosis. HRT consists of using estrogen alone or
various combinations of estrogens and progestins, similar to oral
contraceptives. Some are natural hormones (e.g., estradiol) and others
are semi-synthetic or synthetic (e.g., norgestimate). Since available
HRT products contain estrogen/progestin combinations similar to oral
contraceptives, it is reasonable and consistent to exempt them
similarly.
Recently, studies have raised questions about the health effects of
HRT. A Women's Health Initiative study indicated that women treated for
about 5 years with a combination of estrogen and progestin had an
increased risk of breast cancer, heart disease, stroke and blood clots
compared to placebo. While this study suggests that HRT may not be
indicated for long term use, it did not examine different doses,
different estrogen or progestins or alternative formulations. It is
likely that physicians may consider prescribing short term hormone
therapy for menopausal symptoms after evaluating the risks and benefits
for individual patients. Because the acute toxicity of HRT is low and
its use is likely to continue even with the questions raised about its
long term use, the Commission believes that a rule uniformly exempting
HRT products from CR packaging requirements is appropriate.
C. Toxicity Data
Human toxic doses for estrogens or progestins have not been
defined. Exposure summaries in the Poisindex[reg] 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.
The medical literature provides little information concerning acute
overdosage of progestins or estrogens. One case mentioned in the NPR
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.
For the NPR, the staff reviewed poisoning data from the American
Association of Poison Control Centers (``AAPCC'') Toxic Exposure
Surveillance System (``TESS'') 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.
For this final rule, the staff reviewed available AAPCC data since
the NPR was published, and found no major outcomes or deaths in any of
the hormone categories in 1999 and 2000 (the most recent data
available).
D. Public Comment on the NPR
The Commission received one comment in response to the NPR. It came
from Berlex Laboratories, which wrote that it currently markets
estrogen replacement therapy, long-acting contraception, and oral
contraception products and plans to market an oral HRT product in the
near future. Berlex states that the proposed exemption is ``beneficial
in terms of cost and efficiency'' and provides ``drug producers greater
flexibility in meeting the needs of the HRT patient population.''
E. Effective Date
With this rule, the Commission issues an exemption from the child-
resistant packaging requirements generally applicable to oral
prescription drugs. Thus, the rule imposes no new requirements, but
lifts requirements currently in existence for some HRT products (some
HRT products are already exempt from CR packaging requirements). Under
these circumstances the Commission believes it is appropriate for the
rule to become effective on the date it is published in the Federal
Register.
F. Impact on Small Business
As discussed in the NPR, the Commission preliminarily concluded
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. This
conclusion was based on the fact that 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. Thus, the
exemption is not likely to have a significant impact on a substantial
number of companies, regardless of size.
G. Environmental Considerations
In the NPR, the Commission also discussed possible impact on the
environment as required by the National
[[Page 66552]]
Environmental Policy Act, and in accordance with the Council on
Environmental Quality regulations and CPSC procedures for environmental
review. The Commission found that, because the rule would have no
adverse effect on the environment, neither an environmental assessment
nor an environmental impact statement is required.
H. 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).
Accordingly, with the exceptions noted above, the 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 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 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 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. The introductory text of paragraphs (a) and (a)(10) is
republished. Section 1700.14 is amended by adding new paragraph
(a)(10)(xxi) to read as follows:
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: October 28, 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, ``Final Rule to Exempt Hormone
Replacement Therapy Products from the Special Packaging Requirements of
the Poison Prevention Packaging Act,'' October 9, 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,'' September 9, 2002.
[FR Doc. 02-27745 Filed 10-31-02; 8:45 am]
BILLING CODE 6355-01-P