Managing the Environmental Regulations and Safety
11
Premarketing clearances are based on scientific data submitted by
manufacturers to demonstrate that the proposed product will not have an
adverse effect on human health.
Major provisions of the law include the following:
• The banning of the intentional addition of substances known to
cause cancer in animals to food products (the so-called Delaney
Clause).
• The establishment of procedures for setting safety limits for
pesticide residues on raw agriculture products.
• The required pre-use of safety assessments and approvals of all
food additives.
Another consumer-oriented federal legislation is the
Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), which established
a regulatory program to control the manufacture and use of pesticides
and related products whose purpose is to kill, repel or control insects,
rodents, plants, trees, algae, fungi, bacteria, or other living organisms.
The first
federal legislation to control chemical pesticides was passed in
1910. Like the FFDCA, the early law was aimed against adulterating or
misbranding chemical pesticides to protect consumers against false
advertising. Increased awareness of the health and
environmental risks
posed by new pesticides and by their persistent characteristics
(e.g.,
DDD & DDT), prompted Congress to pass FIFRA. The chief thrust of
the law was to prevent unreasonably adverse effects on the environment
and public health. Under
FIFRA, manufacturers must register all new
pesticides with EPA. The EPA sets tolerance levels for residues before
the substance can be used on food crops. EPA sets residue safety limits
for
raw
(unprocessed ) meat and agricultural products, while the Food
and Drug Administration, under FFDCA, sets pesticide residue limits for
processed
foods. In considering registration of a pesticide, EPA must
evaluate not only its environmental effects, but also its economic, social
and health impacts. EPA may refuse to register pesticides judged unduly
hazardous, or they may impose use restrictions. All restrictions must be
printed on the label and enforcement action can be taken against pesticide
users who do not comply with the printed restrictions. EPA can
condition the registration for general use or restricted use, i.e., that the
pesticide may only be applied by trained and certified applicators. EPA
has the authority to cancel the registration of a pesticide deemed to pose
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