for Child-Resistant Packaging. Federal Register.
SUMMARY: The The Consumer Product Safety Commission is proposing
a rule to require child-resistant (``CR'') packaging for household
products containing more than the equivalent of 50 mg of elemental
fluoride and more than the equivalent of 0.5 percent elemental
fluoride (on a weight-to-volume (``w/v'') or weight-to-weight
(``w/w'') basis). Examples of such products are some rust
removers, toilet cleaners, metal cleaners and etching products.
Dental products, such as toothpaste, contain lower levels
of fluoride and would not be affected. For consistency, the
Commission is also proposing to modify the oral prescription
drug exemption for sodium fluoride preparations. Instead of
allowing drugs with no more than 264 mg of sodium fluoride
per package to be in non-CR packaging as the current rule
does, the Commission proposes to allow such drugs with only
50 mg or less of the equivalent of elemental fluoride (110
mg or less of sodium fluoride) per package and no more than
the equivalent of 0.5 percent elemental fluoride on a w/v
or w/w basis. 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 ingesting a toxic amount
of elemental fluoride. The Commission takes this action under
the authority of the Poison Prevention Packaging Act of 1970.
types of household products may contain fluoride in one form
or another. Fluorides are ingredients in cleaning products
for metal, tile, brick, cement, wheels, radiators, siding,
toilets, ovens and drains. Fluorides are also found in rust
and water stain removers, silver solder and other welding
fluxes, etching compounds, laundry sour, air conditioner coil
cleaners and floor polishes. The fluorides that may be ingredients
in these products and are potentially toxic are hydrofluoric
acid (``HF''), ammonium bifluoride, ammonium fluoride, potassium
bifluoride, sodium bifluoride, sodium fluoride and sodium
household products, particularly metal cleaners and rust removers
containing hydrofluoric acid and/or soluble fluoride salts,
can have as much as 57 percent elemental fluoride. In general,
the concentrations of elemental fluoride in household cleaners
and surface preparation agents are 10 to 1,000-fold higher
than concentrations found in dental products.
Most available toxicity information on fluoride relates to
acute toxicity of hydrofluoric acid (``HF''). However, other
water soluble fluoride-containing compounds can cause fluoride
poisoning. The fluoride ion is systemically absorbed almost
immediately. It is highly penetrating and reactive and can
cause both systemic poisoning and tissue destruction. Fluoride
ions, once separated from either HF or fluoride salts, penetrate
deep into tissues, causing burning at sites deeper than the
original exposure site. The process of tissue destruction
can continue for days.
fluoride poisoning after ingestion or inhalation occurs very
rapidly as the fluoride is absorbed into the gastrointestinal
(``GI'') tract and lungs. Systemic fluoride poisoning can
also result from dermal exposure if the exposure is massive
or the skin barrier has been destroyed, as with severe burns.
Fluoride absorption can produce hyperkalemia (elevated serum
potassium), hypocalcemia (lowered serum calcium), hypomagnesemia
(lowered serum magnesium), and metabolic and respiratory acidosis.
These disturbances can then bring on cardiac arrhythmia, respiratory
stimulation followed by respiratory depression, muscle spasms,
convulsions, central nervous system (``CNS'') depression,
possible respiratory paralysis or cardiac failure, and death.
Fluoride may also inhibit cellular respiration and glycolysis,
alter membrane permeability and excitability, and cause neurotoxic
and adverse GI effects.
exposure is through inhalation, fluorides can cause severe
chemical burns to the respiratory system. Inhalation can result
in difficulty breathing (dyspnea), bronchospasms, chemical
pneumonitis, pulmonary edema, airway obstruction, and tracheobronchitis.
The severity of burns from dermal absorption can vary depending
on the concentration of fluoride available, duration of the
exposure, the surface area exposed, and the penetrability
of the exposed tissue. Dermal exposure to 6 to 10 percent
HF is the lowest concentration range known to cause skin injury
in humans. Destruction of tissue under the skin may occur,
as may decalcification and erosion of bone. Death from systemic
fluoride toxicity has resulted from dermal exposure to 70
percent HF over 2.5 percent of the body surface.
exposure can result in serious eye injury. Exposure to concentrations
of 0.5 percent can lead to mild conjunctivitis and greater
concentrations can lead to progressively severe results such
as immediate corneal necrosis (20 percent solution).