5608
               United States
               Environmental Protection
               Agency
Office of       £•; I
Public Affairs (A-107)
Washington DC 20460
               Regulating   Epi2P4325
               Pesticides
  2

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V

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 Pesticides
The word comes from the Latin cida, "to kill," and
pestis, for "plague," which is exactly what it
means—pesticides are substances used to kill or
control unwanted insects, plants, fungi, mites, ro-
dents, bacteria, or other pests.  More than 34,000
such products—derived from about 600 basic chem-
ical ingredients—are currently registered by the
U.S. Environmental Protection Agency for use in
this country.
  The challenge and complexity of regulating pesti-
cide products and their use arise from the dual na-
ture of the chemicals themselves: Pesticides are of
tremendous value to society, but improperly used
these products can be a threat to human health and
the environment.
  Pesticides contribute significantly to the produc-
tion of food  and fiber, to improved public health
through the  control of disease-carrying pests, and to
the overall quality of life by reducing aggravations
caused by a wide variety of pests. On the other
hand, pesticides can affect non-pests as well. Each
year, almost 2 billion pounds of pesticides are used
to gain the benefits they offer. If not handled cor-
rectly, the more toxic substances can present an  im-
mediate danger to the user and even death if spilled
on the skin, inhaled, or otherwise misused. Some of
the earlier pesticides also persist in the environment
over long periods of time, moving up through the
food chain—from plankton or insects to birds, fish,
animals, and eventually to humans through food.
Finally, some pesticides  exhibit evidence of long-
term adverse health effects under some conditions.
In short, while most of us initially considered pesti-
cides to be a sort of modern day miracle, we have
now come to. view them more circumspectly.
  EPA's mission is to assure that society reaps the
benefits of pesticide use with minimum risk to
health and the environment.  It is an extremely dif-
ficult job which at times requires choices to be
made at the  outer limits of current scientific know-
ledge.

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FIFRA and FFDCA
EPA regulates pesticides under two laws: the Feder-
al Insecticide, Fungicide, and Rodenticide Act (FIF-
RA) and the Pesticide Amendment to the Federal
Food, Drug, and Cosmetic Act (FFDCA).
  FIFRA was enacted originally in 1947 and was
then administered by the U.S. Department of Agri-
culture. EPA assumed this responsibility when it
was established in 1970.
  The 1947 law made it illegal to detach or destroy
pesticide labels and  provided for pesticide in-
spections, but it did  not address actual pesticide use
and was not applicable to pesticides used solely
within a single state. Despite the 1947 legislation,
reports of pesticide-related health and environment
problems became increasingly alarming in subse-
quent years.
  In 1972, Congress  amended FIFRA to provide for a
broader regulatory program, covering all pesticides
used in the United States instead  of only those in-
volved in interstate commerce. Under this legisla-
tion, all pesticides must be registered  by EPA before
they can be sold to the public, and misuse of a reg-
istered pesticide is unlawful.
  The Pesticide Amendment of the FFDCA provided
an additional measure of public protection by au-
thorizing the establishment of "tolerances." These
are amounts of pesticide residues that may safely
remain on a treated  food or feed crop after
harvesting. Tolerance levels must be established for
all pesticides used on food or feed crops.

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Registration and
Re-registration
EPA registers specified uses of pesticide products
on the basis of both safety and benefits. FIFRA re-
quires EPA to determine whether a pesticide can
perform its intended function without causing "un-
reasonable adverse affects" upon human health or
the environment while taking into account the
potential benefits of the proposed use. This
balancing of risks and benefits  underlies all basic
regulatory decisions under the  Act.
  To make sound judgments, EPA must have all
pertinent information on every  pesticide it evalu-
ates. Manufacturers of pesticides are required to
provide data on the potential for skin and eye irrita-
tion; hazards to non-target organisms including fish
and wildlife; the possibility of acute poisoning,
tumor formation, birth defects,  reproductive im-
pairments, or other serious health effects; the be-
havior of the chemical in the environment after ap-
plication;  and the quantity and  nature of residues
likely to occur  in food  or feed crops.
  Amassing health-related data is not limited to
new, unregistered pesticides. Amendments to FIFRA
enacted in 1972 require EPA to  reassess the safety
of pesticide chemicals already in use.  Most older
pesticides do not meet the standards of testing re-
quired now. In the  re-registration process, therefore,
manufacturers of these older products must meet
the same testing standards which new chemicals
must meet. This  normally requires under-taking
and completing various tests which are then reviewed
by the Agency to determine whether products may
remain on the  market.
  If a pesticide ingredient poses a special concern
due to a perceived  health or environmental risk, the
agency can conduct a  special review of the pro-
duct's risks and benefits. The review process allows
all interested parties—the general public, environ-
mentalists, pesticide users, manufacturers, and sci-
entists to participate. At the conclusion  of a special re-
view, EPA may decide to continue, restrict, or cancel
pesticide uses under consideration. A  regulatory de-
cison to cancel uses of a pesticide may be appealed
to the EPA Administrator for an adjudicatory hearing.

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Tolerances
Tolerance levels—the amount of pesticide that may
remain on a crop after harvesting—must be es-
tablished under federal law for all registered pesti-
cide uses expected to result in residues in raw agri-
cultural commodities, processed food or feed. Toler-
ances are legal enforcement levels set well below—
normally 100 times below—the level  that might
cause harm to people or the environment.
  The Food and Drug Administration, which en-
forces tolerances, inspects agricultural commodities,
both domestic and  imported, to insure that residues
in food to be offered for sale in the marketplace do
not exceed the limits established by EPA. In addi-
tion, the U.S. Department of Agriculture inspects
meat and  poultry for such residues. Any food found
to have residues  in excess of the tolerance level is
subject to seizure and destruction.

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FIFRA  Enforcement
EPA and its state partners share the responsibility
for pesticide enforcement. Their trained personnel
continually check on marketed pesticide products.
Samples are collected from manufacturers and dis-
tributors in all parts of the country. These are field
tested and analyzed in government laboratories for
verification of label claims concerning content,
effectiveness, and safety. Labels are reviewed to de-
termine that no claims are  made other than those
accepted by  EPA at the time of registration.
  If a product is found to be ineffective or unsafe,
EPA may take one of several actions. In the case of
a minor violation, an informal notice to the com-
pany concerned is usually sufficient to insure the
correction of a deficiency. More serious cases may
result in a formal notice  of violation, seizure of the
company's goods, or initiation of civil or criminal
proceedings against the  violator.
  When a question arises about the safety of a pes-
ticide currently in use, EPA may issue a formal
notice of cancellation that becomes effective within
30 days unless appealed. If the cancellation is chal-
lenged, the product  registration  remains valid and
marketing may continue pending the completion of
the appeal process.
  If immediate action is warranted, EPA can  sus-
pend the registration of a pesticide determined to
be an  imminent hazard to the public welfare. This
action halts further sale,  distribution or shipment of
the pesticide, regardless of any appeal by the manu-
facturer, until a decision  is  made through the
cancellation  procedure.

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Classification  and
Certification
EPA must classify all pesticide products for either
"general" or "restricted" use.
  General use pesticides are primarily those that
will not cause  unreasonable adverse effects to the
user or the environment when used in accordance
with label instructions. Such products generally are
available to the public with no restrictions other
than those specified on the  label.
  Restricted use pesticides are those which may
cause adverse effects to the applicator or the en-
vironment unless applied by persons who have
been specially trained in their use.
  The law provides for government certification of
applicators qualified to handle and apply restricted
use pesticides without harming themselves, others,
or the environment. Actual training of applicators,
as well as certification, is carried out at the state
level by the states and the Cooperative Extension
Service. Virtually all states now have an active
certification program. To become certified, applica-
tors must demonstrate an understanding of labeling;
safety requirements; environmental factors;
consequences of pesticide misuse; hazards associ-
ated with residues; equipment use, and  application
techniques.

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             Read the  Label
              One of the most important outcomes of the registra-
              tion process is the product label, which must be
              written to exacting specifications and appear on ev-
              ery pesticide container. Labels should be  read in
              their entirety before use of a pesticide product. The
              user should be aware that it is illegal to use a pesti-
              cide in ways inconsistent with its labeling. Informa-
              tion on the label includes:
              The EPA registration number. This number assures
              the user that the product is legally registered and
              considered safe to use as directed.
              Directions for use. Always use a pesticide only on
              the sites specified and in the  prescribed amounts.
              Don't think that twice that amount will double the
              effectiveness. It won't. It will only enhance the
              possibility of unintended harm, either to the user,
              houseplants, crops, etc. Some labels include di-
              rections for special applications, such as misting
              plants.
              Precautions. Pesticides with the highest degree of
              toxicity are marked with a skull and crossbones and
              state DANGER-POISON; the word WARNING
              appears on the labels of less toxic  pesticides; and
              CAUTION is used on the least harmful products. Pay
              special attention to any instructions regarding pre-
              cautions for children and pets or the need for pro-
              tective clothing. Heed instructions about accidental
              spills on skin or clothes.
              Read first-aid instructions.  Follow these instructions
              if an accident occurs.  Call a poison control center
              and use the label to describe the chemical. If the
              accident results in a visit to a doctor or hospital,
              take the label with you.
              Storage and disposal. Store the product in the ori-
              ginal container. Never transfer a pesticide to a soft
              drink bottle or any other container that might be
              attractive to children.  Dispose of empty containers
              as recommended by any special label instructions.
US. r-v%^:*<  •*'•   !<-^     Agency
Chicago,

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