United States Region 5
Environmental Protection 230 South Dearborn Street
Agency Chicago, Dlinois 60604
Food Safety
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INTRODUCTION
Just how safe is the food we eat?
As we learn of the many pesticides that are routinely applied
to the country's food crop, several questions arise:
Are we at risk from pesticide-treated food?
Are we being unnecessarily exposed to cancer-causing
chemicals?
Do laws regulating pesticides in our food supply adequately
protect us?
Because most pesticides must be toxic to kill insects, elimi-
nate weeds, slow-down spoilage, speed up or retard growth,
and improve the appearance of some fruits and vegetables —
these are legitimate concerns.
This brochure will explain how the U.S. Environmental Pro-
tection Agency (EPA) goes about registering a pesticide that
will be applied to food or feed produce.
NATURAL CONTAMINANTS
The use of pesticides provides an abundance of insect-and
disease-free foods at a relatively low cost. However, there is no
way to prove that a pesticide is totally risk-free in all uses and
at all dose levels. In fact, there is some inherent risk in every
action we take and in everything we eat.
Even eating food without pesticide residues is not totally
risk-free. Some so-called natural or organic fruits and vege-
tables may also present risks. Examples of foods with natural
toxins include lima beans (which may have traces of cyanide)
and peanut butter (which may contain a carcinogenic mold call
aflatoxin). These contaminants can make you sick if consumed
in large enough quantities. So, even pesticide-free foods may
be poisonous.
FEDERAL INSECTICIDE, FUNGICIDE,
AND RODENTICIDE ACT
The use of pesticides in or on our food is regulated under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
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Enacted in 1947, this law requires EPA to protect public health,
wildlife, and the environment from unreasonable adverse ef-
fects of pesticides. In addition, EB\ must balance risks to
public health, wildlife, and the environment against the social,
economic, and environmental benefits identified with a
pesticide's use.
Pesticides include insecticides, herbicides, fungicides, roden-
ticides, disinfectants, and other substances that control pests.
Today, there are about 25,000 pesticide products registered in
the United States.
REGISTRATION PROCESS
Before a pesticide can be legally sold and used in this country,
it first must be licensed, or registered, with EPA. The pesticide
manufacturer must show that the pesticide meets all require-
ments for registration under FIFRA. These requirements
include: description of the pesticide's chemistry, toxicity
tests, any known effects on people and wildlife, studies of
pesticides on crops that will be used as food or as livestock
feed, and pesticide behavior in the environment.
EPA evaluates this information and decides whether to
approve a new pesticide. If it approves a pesticide, EPA
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assigns a product registration number and a pesticide manu-
facturer's number. In addition, EPA reviews and approves the
language on the product container, which specifies how the
product should be used. It is illegal to use a pesticide for a
purpose, or in a manner, other than stated on the label.
ASSESSING RISK
During the registration process, EPA evaluates the exposure to
a pesticide and the potential for disease. Experimental studies
are done with animals (usually mice or rats) to estimate the
chances of disease as a direct result of pesticide exposure.
Animal toxicity studies are based essentially on the theory that
pesticide effects on humans can be inferred indirectly from
their effects on animals. Mathematical models are used to
make these inferences.
Typically, data used in this registration process come from
studies of animal exposure to much higher levels of pesticides
than the exposure levels expected for humans. Studies include
testing animals for acute toxic reactions, (such as cancer, birth
defects, and damage to the nervous system, including visual
problems, muscle twitching and weakness, and behav-
ioral problems). Studies also note fetal abnormalities, which
may result if either parent was exposed to pesticides before
conception.
These long-term studies begin with young animals, and
continue through their adulthood, thereby imitating human
exposure that begins in childhood and continues over a
lifetime.
Therefore, when looking at potential adverse effects, it is
important to consider the duration and frequency of pesticide
exposure as well as pesticide dosages. Repeated exposures,
because of a possible pesticide buildup in body tissue, can
produce a very different reaction from a single exposure.
It generally takes 6 to 9 years from the time a new pesticide
is developed in a company laboratory until it is placed on the
shelf for sale. When a pesticide is registered by EPA, you can
be sure that the pesticide's health and environmental effects
have been thoroughly reviewed by EPA scientists.
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CANCELLATION PROCESS
After a pesticide have been registered, if new information
shows the pesticide may pose an unreasonable risk to public
health or the environment, EPA can revoke its registration.
This is called cancellation of a product's registration or
suspension of a product's registration. In some cases, the
registration may be suspended until additional studies can be
done.
If an imminent hazard is found, an emergency suspension
can immediately stop the use of a very dangerous pesticide
while the cancellation process is in progress.
The cancellation proposal can be challenged by the pesti-
cide manufacturer and by other affected groups. If the cancel-
lation order is challenged while it is being reviewed, the
pesticide may be used until the cancellation proceedings are
completed — unless that particular use has been suspended.
SETTING TOLERANCES
Under the Federal Food, Drug, and Cosmetic Act, EPA not
only registers pesticides but also sets tolerances for pesticides
used on food or feed crops. A tolerance is defined as the
maximum amount of a pesticide that can safely remain in or
on food or feed.
When a pesticide is intended for use on food or feed crops,
manufacturers must file a request with EPA to establish a
tolerance level. This request musi be submitted with the
application for registration. EPA will not register a pesticide
for use on food crops until a tolerance level has been approved.
FIELD TESTS
The manufacturer proposes pesticide tolerance levels based
on field trial data. This information reflects the maximum
residue levels under "worst-case" conditions. For example,
crops receive the highest-recommended pesticide doses dur-
ing the maximum number of times allowed. These tests are
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also conducted under weather conditions that would prolong,
and in some cases increase, pesticide residues. Therefore, the
"worst case" assumptions usually point toward a more restric-
tive tolerance than indicated by actual pesticide residues at
harvest.
APPROVING AND DISAPPROVING TOLERANCES
EPA establishes tolerance for pesticides residues only when
toxicological data show that the expected levels will not pose
significant dietary risks to consumers even after a lifetime of
pesticide exposure. If the data indicate that exposure and risk
are high and that harm is likely to occur, EPA will not approve
a tolerance.
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If EPA does not approve a tolerance, manufacturers can
take several steps. They can change the application rate or
methods, so that lower residues will remain; they can also
lower the proposed tolerance level, eliminate one or more
uses, or develop additional information to support their
original proposal.
If EPA still does not approve the tolerance level, manufac-
turers cannot sell the pesticide for specific food or feed use.
Several different pesticides may be used on a particular fruit
or vegetable, but each pesticide must have its own tolerance
level approved by EPA.
In general, most pesticide residues tend to break down as
time passes after harvest. If residues are at maximum tolerance
when the produce leaves the farm, by the time it reaches the
consumer, residue levels will most likely have been reduced.
Tolerance levels may be further reduced by washing, peeling,
cooking, and processing the food.
Some pesticides are systemic, meaning that they are ab-
sorbed by fruits or vegetables and cannot be removed by
washing or peeling. Legal tolerances, however, protect con-
sumers from unsafe pesticide residue levels, even if the
residues are not reduced before the food is eaten.
ENFORCING TOLERANCES
EPA-set tolerance levels are enforced by the Food and Drug
Administration, the U.S. Department of Agriculture, and the
State enforcement agencies. The United States food supply,
whether grown here or imported, is monitored not only for
compliance with pesticide tolerances, but for the presence of
aflatoxin, salmonella, and other microbiological contami-
nants. Federal and State inspectors regularly sample food and
feed produce soon after a treated commodity is sent to the
market.
SPECIAL CONCERN FOR INFANTS AND CHILDREN
When establishing food tolerances, EPA is especially con-
cerned about infants and children. To guard against possible
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problems, EPA routinely calculates lifetime exposure levels
for adults as well as for infants and children who may have
higher exposures.
EPA's analysis of pesticides in the diet takes into account
that infants and children typically eat more food in relation to
their body weight—and more of certain types of food—than
average adults. Using these exposure estimates, EPA calcu-
lates risks accordingly. For example, children generally drink
more milk, so this is taken into consideration when EPA sets
a tolerance for pesticide residues in milk.
Thus, EPA's tolerance-setting system protects the average
person against any short-or long-term harm that might come
from a lifetime of exposure to pesticide residues in food,
including exposure during childhood.
There have been mixed results concerning the extra chem-
ical sensitivity of infants and children. Some studies indicate
they are more sensitive to toxic-chemical exposure when
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compared to adults, while other studies say they are less
sensitive. To correctly assess this situation, EPA has asked the
National Academy of Sciences to do a study on this issue and
recommend changes, if any, to the EB\ regulatory process.
The final report is expected to be out in the spring of 1991.
FURTHER LIMITING EXPOSURE
Throughout our lives, we regularly consume small amounts of
pesticides. Meat, fish, produce, poultry, eggs, and milk, are all
likely to contain some pesticide residues. Even though EPA
limits dietary pesticides through tolerances, you can further
reduce your exposure:
Q Rinse fruits and vegetables thoroughly with clear water.
Scrub them with a brush and, where possible, peel them.
This will not remove systemic (absorbed) pesticide
residues; however, it will remove much of the surface
residues.
Q Cook or bake food to reduce the amount of some (but
not all) pesticide residues.
Q Trim the fat from meat, fish, and poultry. Some pesti-
cide residues concentrate in fat.
Q Do not eat fish from contaminated ponds or lakes.
Follow fish advisories of your State.
Q Avoid hunting wild game in areas where pesticide
usage is very high.
Q If possible, grow your own food without the use of
pesticides.
AMENDMENTS TO FIFRA
While EPA feels that the country's food supply is the safest in
the world, it is committed to making food even safer. On
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October 22,1988, President Reagan signed the amendments
to FIFRA. One important provision;of the amendments gives
EPA the authority and additional resources to complete, in 9
years, the updating of information on 600 or so pesticides
registered before 1984 and to re-evaluate the data on those
chemicals.
Even though EPA has an ongoing process to suspend or
cancel unsafe pesticides, this provision will ensure that all
previously registered pesticides measure up to current, more
advanced, scientific and regulatory standards. To complete
the reregistration review of existing pesticides in 9 years
represents an enormous challenge to EPA.
In addition, on October 26,1989, President Bush proposed
a program to further increase food safety. The President's
plan will:
Q Require all registrants to provide information to
EPA, within established time frames, to determine
if pesticides meet current standards. If the infor-
mation is not provided, EPA can suspend the
registration.
Q Define more precisely an "imminent hazard" posed
by a pesticide and give EPA the authority to remove
pesticides so designated from the market.
Q Make it easier to cancel the use of a pesticide that is
found to be harmful to public health.
Q Increase penalties for misusing pesticides and give
EPA more authority to hold inspections and to collect
the necessary data on the distribution, use, and testing
of pesticide products.
Q Establish risk standards for pesticide residues in
processed food, as well as in raw commodities, below
what is considered to be a threat to the public health.
Q Establish uniform pesticide tolerances by making
State or local standards identical to Federal standards
for the same chemical substance.
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SUMMARY
^ j EPA is constantly working to identify and reduce or elimi-
nate unnecessary risks associated with pesticide-treated foods.
To this end, EPA continues to focus its efforts on collecting
more complete information about pesticides to better assess
dietary exposure. The revisions to FIFRA and the plan pro-
posed by the President will go a long way toward helping EPA
achieve this goal.
In short, if EPA believes that a pesticide poses an unreason-
able risk to the Nation's food, it can—and will—remove that
pesticide from the market to protect the American public.
For more information regarding pesticides and food, contact
EPA's hotline in the Office of Public Affairs at 1-800-572-
2515 in Illinois, or 1-800-621-8431 in Indiana, Michigan,
Minnesota, Ohio, and Wisconsin.
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U.S. GOVERNMENT PRINTING OFFICE. 1991-54J-880
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