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U.S. regulatory information
 U.S. EPA Registered
Restricted Use Pesticides (RUP)
Reregistration Eligibility Decision
(RED)
Special Review
Section 18 Emergency Exemption
Section 25(b): Minimum Risk Pesticides
Special Local Needs
(FIFRA Section 24(c))
U.S. EPA Hazardous Air Pollutant
Pesticide Residue Tolerances
U.S.
EPA Registered
The chemicals listed as
U.S. EPA registered are those that can currently be legally used
in the U.S., except in states where state laws are stricter than
federal laws and prohibit such use. Because the U.S. EPA does not
publish a list of registered active ingredients, PAN compiled the
list of U.S. EPA registered active ingredients using the following:
- California's
list of registered active ingredients. According to California
Department of Pesticide Regulation staff, if a pesticide active
ingredient is registered for use in California, it is registered
in the U.S.�
- The U.S. EPA's list of registered
pesticide products. If
the chemical is contained in a currently registered product, it
is assumed to be a registered active ingredient.
About the Data: Accuracy,
currency, comprehensiveness and source
The U.S. EPA does not maintain
a database of currently registered active ingredients. To compile
a list of U.S. EPA Registered chemicals we used the list of registered
active ingredients in California and added to this any chemical
ingredient in currently active U.S. EPA-registered pesticide products.
This list includes approximately 1290 registered active ingredients
(AIs). As new active ingredients are registered, these are announced
on U.S. EPA's Web site and in the Federal
Register. U.S. EPA Pesticide product data files are updated
nightly. PAN updates this information 2-4 times per year, most recently
on May 15, 2002.
Reference:
U.S. EPA
Pesticide Product Information System, U.S.
EPA. Viewed on October 31, 2002.
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Restricted
Use Pesticides (RUPs)
The U.S. EPA (1) restricts
use of some pesticide products because they are acutely toxic to
humans or beneficial insects; have been shown to cause worker illnesses,
groundwater contamination, bird or fish kills; or their drift damages
other crops. RUPs can be used only by certified and licensed applicators,
and then only under specific conditions.
About
the Data: Accuracy,
currency, comprehensiveness and source
This data is part of the
Pesticide
Product Information System, maintained by the U.S. EPA. Additionally,
a list of Restricted Use Products is published by the U.S. EPA that also includes information on banned pesticides.
This list is only marginally useful, in that it does not clearly
specify whether all products containing a chemical are banned
or restricted and it does not clearly define the system used to
classify pesticides. However, the summary of chemicals with changes
in restricted use status is helpful.
Reference:
U.S. EPA Restricted Use
Product Report, U.S. EPA. Viewed on October 31, 2002.
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Reregistration
Eligibility Decision (RED)
Under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), U.S. EPA must reassess the
human health and environmental effects of pesticide active ingredients
registered before November 1, 1984. This "reregistration" process
is designed to subject older pesticides to the stricter contemporary
health and safety standards used for pesticide registration after
1984, with the intent of reducing risks associated with their use.
To be eligible for reregistration, a pesticide must be found not
to cause unreasonable risks to people or the environment when used
in accordance with its approved labeling. The results of this review
process are available in the form of Reregistration Eligibility
Decision (RED) documents. As of December 2000, only 209 chemicals
(out of approximately 600) have been re-evaluated through the RED
process (1, 2).
Since the passage of the
U.S. Food Quality Protection Act (FQPA) of 1996 (2), the process
for reregistering pesticides has changed dramatically and the old
RED process is no longer being used. Risk assessments under FQPA
must now be applicable to sensitive groups (children, in particular)
and take into consideration aggregate exposure to a single chemical
from all possible sources. In addition, exposures to pesticides
which have the same toxicological mode of action must be considered
together. Where data gaps exist, extra safety factors are supposed
to be used.
About the Data: Accuracy,
currency, comprehensiveness and source
Reregistration
status information is not currently included in the PAN Pesticide
Database.
References:
- Pesticide Reregistration
Eligibility Decisions (REDs), U.S.
EPA. Viewed on October 31, 2002.
- Status
of Pesticides in Registration, Reregistration, and Special Review,
U.S.
EPA, Spring 1998. Viewed on October 31, 2002.
- U.S.
Food Quality Protection Act (FQPA) of 1996, U.S.
EPA. Viewed on October 31, 2002.
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Special
Review
Under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA),
the U.S. EPA is given the authority to register a pesticide for
use if it is determined that "it will perform its intended function
without unreasonable adverse effects on the environment" (1). Unreasonable
adverse effects are defined as "any unreasonable risk to man or
the environment, taking into account the economic, social, and environmental
costs and benefits of the use of any pesticide" (2). If the U.S.
EPA has reason to believe that the use of a pesticide may result
in unreasonable adverse effects, a Special Review of the product
can be initiated (3, 4). The outcome of these special reviews can
result in a change in use restrictions, a ban of the pesticide entirely,
voluntary withdrawal of registrations, or no change.
The Special Review Process
is the mechanism by which the U.S. EPA gathers information on the
risks and benefits of a particular pesticide in order to determine
if its use results in unreasonable adverse effects to human health
or the environment. The six criteria for the initiating a Special
Review of a pesticide use are as follows (5):
- Acute toxicity
to humans or domestic animal.
- Potential
chronic or delayed toxic effects in humans.
- Potential
hazards to non-target organisms.
- Risk to
the continued existence of any threatened or endangered species.
- Risk of
destruction or other adverse modification of a critical habitat
of any threatened or endangered species
- Any other
adverse effect to humans or the environment which may outweigh
the benefits that justify initial of continued registration.
The goal of the Special
Review process is to estimate the risks posed by a pesticide and
determine if these risks are acceptable when taking into consideration
the benefits provided by the use of that pesticide. If the risks
are determined to outweigh the benefits, these risks must be in
some way reduced. This reduction in risk can be achieved either
by canceling the registration or restricting the use of the pesticide.
If the risk is determined to be outweighed by the benefits of use,
the continued registration of the compound without any changes may
be warranted.
About the Data: Accuracy,
currency, comprehensiveness and source
Special review
status information is not currently included in the PAN Pesticide
Database.
References:
- 7 U.S.C. 136 3(c)(5).
- 7 U.S.C. 136 2(bb).
- Special
Review, U.S.
EPA. Viewed on October 31, 2002.
- Prior to 1986, the name
used for the Special Review process was "Rebuttable Presumption
Against Registration" (RPAR).
- 40 Code
of Federal Regulations (CFR), Part 154.7. Viewed on October 31, 2002.
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Section
18 Emergency Exemption
Under Section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the
U.S. EPA can allow States to use a pesticide for an unregistered
use for a limited time if U.S. EPA determines that emergency conditions
exist (1, 2). Emergency situations can include the need to control
unexpected pest outbreaks or to prevent the spread of disease. Most
requests for emergency exemptions are made by state lead agricultural
agencies. These requests are made when a problem situation which
registered pesticides will not alleviate is identified. Requests
for a Section 18 emergency exemption are most often made for pesticides
that have other food uses registered. The uses are requested for
a limited period of time (no longer than 1 year), to address the
emergency situation only. U.S. EPA may issue such an exemption if
it determines that an emergency exists and that the emergency use
of the pesticide will not cause unreasonable adverse effects on
the environment.
About the Data: Accuracy,
currency, comprehensiveness and source
Section 18 Emergency
Exemption information is not currently included in the PAN Pesticide
Database.
References:
- FIFRA Section 18,
U.S.
EPA. Viewed on October 31, 2002.
- Pesticide Regulation Handbook, 3rd Ed., McKenna &
Cuneo and Technology Services Group, Inc., Executive Enterprises
Publications, Co., (New York, NY, 1991), page 86.
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Section
25(b): U.S. EPA Minimum Risk Pesticides
Section 25(b) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) exempts certain
pesticides from regulations requiring registration of the product
(and all the attendant data submission requirements). To
qualify as a "minimum risk" pesticide, a product can contain
only approved active ingredients, a list of approximately 30 compounds
that are mostly of botanical origin and frequently found in edible
foods, e.g., garlic oil, cloves, peppermint (1, 2). In addition,
such products can only contain "minimum risk" inert ingredients
as defined in List 4A, published in the Federal Register (3).
The state of California
adopted similar regulations regarding "minimum risk" pesticides
in May 2000 (4).
About the Data: Accuracy,
currency, comprehensiveness and source
The Section 25(b)
list in the PAN database contains 42 chemicals and was taken from
reference 2, published on May 7, 2000. As of 11/11/02, this is the
latest data available. New substances are added to this list occasionally,
but not on a specified timeline.
References:
- 40 Code
of Federal Regulations (CFR), part 152.25(g)(1).
- Pesticide Registration
Notice 2000-6, U.S.
EPA, May 7, 2000. Download.
Viewed on October 31, 2002.
- Federal
Register,
Sept. 28, 1994. Viewed on October 31, 2002.
- California
Code of Regulations, Title 3, Division 6, Chapter 2, Subchapter
1, Article 1, § 6147. Viewed on October 31, 2002.
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Special
Local Needs (FIFRA Section 24(c))
Section 24(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) allows states
to register either an additional use of a previously registered
pesticide product or a new product to meet "special local needs"
(1, 2). A "special local need" is a pest problem which already exists
or is likely to exist in the state and which cannot be controlled
adequately with any currently registered pesticide. The state has
the responsibility for determining when this situation exists. The
Federal U.S. EPA then reviews the request, and may disapprove the
state request if the use is not covered by necessary tolerances,
or the use has been previously denied, disapproved, suspended or
cancelled by the Federal U.S. EPA.
Such registrations often
involve altering the way a currently registered product is used.
For example, the special local needs registration may allow a pesticide
to be used on corn when it is only registered for use on soybeans.
Other examples include allowing the pesticide to be used to control
a different pest, or allowing it to be applied in a different way
or at different times during the growing season.
About the Data: Accuracy, currency, comprehensiveness
and source
Special Local Needs
information is not currently included in the PAN Pesticide Database.
References:
- Guidance on FIFRA
Sect. 24(c) Registrations, U.S
EPA. Viewed on October 31, 2002.
- Pesticide Regulation Handbook, 3rd Ed., McKenna &
Cuneo and Technology Services Group, Inc., Executive Enterprises
Publications, Co., (New York, NY, 1991), page 299.
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of page
U.S.
EPA Hazardous Air Pollutants (HAPs)
The 1990 Clean
Air Act Amendments (Section 112) listed a number of hazardous air
pollutants in order to identify pollutant source categories for
which EPA would be required to establish technology-based emissions
standards. These substances include certain volatile organic chemicals,
pesticides, herbicides, and radionuclides that present health hazards,
based on scientific studies of exposure to humans and other mammals
(1).
Human exposure to these pollutants at sufficient concentrations
and durations can result in cancer, poisoning, and rapid onset of
sickness, such as nausea or difficulty in breathing. Other less
measurable effects include immunological, neurological, reproductive,
developmental, and respiratory problems. Pollutants deposited onto
soil or into lakes and streams affect ecological systems and eventually
human health through consumption of contaminated food (2).
About the Data: Accuracy,
currency, comprehensiveness and source
The list of HAPs
contains 334 chemicals and chemical groups. We then applied the
chemical group categories to individual compounds in our data set.
For example, the list includes a term called "arsenic compounds",
so we found all arsenic compounds in the database and labeled them
as HAPs. The EPA must periodically review the list of hazardous
air pollutants and, where appropriate, revise this list by rulemaking
procedures. The list was last revised in January of 1999. PAN downloaded
the data from reference 1 on December 30, 2000. Changes in the list
are announced in the Federal Register and at the Unified Air Toxics
Website (3).
References:
- Section
112 Hazardous Air Pollutants, U.S.
EPA Viewed on October 31, 2002.
- Unified
Air Toxics Website: Basic Facts, U.S.
EPA Viewed on October 31, 2002.
- Unified
Air Toxics Website: Rules & Implementation, U.S.
EPA. Viewed on October 31, 2002.
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Pesticide
Residue Tolerances
Even when applied legally,
many pesticides leave residues in or on treated food such as fruits,
vegetables, grains and other commodities. Pesticide residues may
remain in both fresh produce (like apples or tomatoes) and processed
foods (like applesauce or tomato catsup) (1). Residues are difficult
(if not impossible) to remove by washing the produce, since most
pesticides do not dissolve readily in water. Peeling fruits and
vegetables may offer some reduction in pesticide residues; however,
some pesticides are taken up systemically by the plant and are distributed
throughout the plant tissue. For these pesticides, neither washing
nor peeling is effective in reducing residue levels.
In an attempt to address
the health issues associated with consumption of these residues,
U.S. EPA sets tolerances, or maximum residue limits (MRLs), on the
amount of pesticide residue that can lawfully remain in or on each
treated food commodity. In establishing tolerances, U.S. EPA considers
the toxicity of each pesticide, how much of the pesticide is typically
applied and how often, how much of the pesticide (i.e., the residue)
remains in or on the produce, and how much of the produce is typically
consumed.
Pesticide tolerances are
enforced by the Food and Drug Administration (FDA), which monitors
domestically produced and imported foods traveling in interstate
commerce except meat, poultry, and some egg products. In addition,
the FDA carries out the Total Diet Study in order to estimate typical
dietary intakes of pesticides. In theory, produce with residues
exceeding tolerance levels is not allowed to go to market. In practice,
however, only a small fraction of marketed produce is actually tested,
so the system does not guarantee that all produce will be safe to
eat. In fact, a simulation of pesticide residues encountered in
a typical diet shows that it is possible to exceed "safe" levels
of pesticide residues, particularly for children. The Environmental Working Group has developed a tool that
uses actual pesticide residue data to help you estimate your own
exposure to pesticides through food residues (2).
Are these tolerances
truly protective of human health?
We don't really know. The
process of risk assessment only takes into account the hazards we
know about. In most instances, when we look closer at the effects
of pesticides on biological systems (like humans), we find damaging
effects we were unaware of previously. At present, one of the biggest
unknowns are the endocrine
disrupting effects of certain pesticides.
The endocrine-disrupting pesticides are of concern because they
can disrupt the proper functioning of the endocrine system even
at very low levels, which throws into question the fundamental idea
of a "safe" level of pesticides on foods.
In addition, risk assessment
only assumes exposure to a single chemical. Food residue data show
that we are frequently exposed to multiple pesticides simultaneously
in our food. With the passage of the federal Food Quality Protection
Act of 1996, the U.S. EPA is now required to evaluate aggregate
exposures to pesticides that act by a similar mechanism (3). The
U.S. EPA has just begun this analysis, with the organophosphorus
and carbamate pesticides targeted to be evaluated first.
Other routes of exposure
besides food exist as well--drinking water, flea collars, ant and
roach sprays and other home pest control products, and agricultural
pesticide applications for those who live in rural areas. In short,
the real world is very different than the situation assumed by risk
assessors, thus limiting the value of risk assessment in estimating
the potential hazards of pesticides.
About the Data: Accuracy,
currency, comprehensiveness and source
Tolerance data
are not currently included in the PAN Pesticide Database.
References:
- The EPA
and Food Security, U.S. EPA. Viewed on October 24, 2002.
- FoodNews,
Environmental
Working Group. Viewed on 9/2/2000.
- U.S.
Food Quality Protection Act (FQPA) of 1996, U.S.
EPA. Viewed on October 31, 2002.
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Last updated
November 11, 2002
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