II. Risk Assessment and Statutory Findings
Consistent with section 408(c)(2)(B), EPA has reviewed the
available scientific data and other relevant information in support of
this action. Formic acid occurs naturally in honey at levels up to 138
parts per million (ppm), with natural concentrations found most often
in the 9 to 100 ppm range, depending upon the source of the nectar. It
is also a natural component of cheeses (9 to 28 ppm),
peaches (6.5
ppm)
, and other foods. In addition, the product label requires that
formic acid treatment be discontinued at least 4 weeks before the
beginning of surplus honey flow. This will effectively discontinue
formic acid use 6 weeks before honey harvest. Residue studies suggest
that this interval is sufficient to preclude residues of formic acid
above background levels naturally found in honey. The U.S. Food and
Drug Administration (FDA) permits formic acid to be used as a synthetic
flavoring agent in foods (21 CFR 172.515), and has included ethyl
formate in its listing of substances (21 CFR 184.1295) added directly
to human food, which have been found to be Generally Recognized as Safe
(GRAS).
...
A. Toxicological Profile
The mammalian toxicological data considered in support of the
exemption from the requirement of a tolerance for formic acid include
the following studies available in the published literature: Acute oral
LD50 studies in rats, mice, and dogs; acute inhalation studies in
rats and mice, eye and skin irritation studies in rabbits, subchronic
inhalation studies in rats and mice, and an Ames/Salmonella
mutagenicity assay with and without rat liver S9 activation.
The results of these studies indicate that formic acid has very low
toxicity by the oral route. Formic acid has an acute oral LD50 of
1,100 mg/kg in rats; 700 mg/kg in mice; and 4,000 mg/kg in dogs,
However, formic acid is a severe eye irritant, and corrosive to the
skin. The inhalation LC50 is 15 gm/m3 in rats and 6,200 mg/
m3 in mice.
Así, tendria que consumir como unos 350kg de miel por morirte por acido formico..
At 100 ppm the vapors are ``immediately dangerous to
life and health'' for humans, causing respiratory irritation, tearing,
coughing and headache followed in 6 to 8 hours by pulmonary edema,
dizziness, frothy expectoration, and cyanosis (bluish skin
discoloration due to lack of oxygen in the blood). Breathing lower
concentrations over time can lead to erosion of the teeth, local tissue
death in the jaw, bronchial irritation with chronic cough, frequent
attacks of bronchial pneumonia, and gastrointestinal disturbances. The
OSHA standard for occupational exposure is 5 ppm. Formic acid was not
mutagenic in the Ames/Salmonella assay.