Pesticide Law: A Summary of the Statutes

Pesticide Law: A Summary of the Statutes
Updated November 17, 2008
Linda-Jo Schierow
Specialist in Environmental Policy
Resources, Science, and Industry Division

Pesticide Law: A Summary of the Statutes
Summary
This report summarizes the major statutory authorities governing pesticide
regulation: the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and
Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), as well as the
major regulatory programs for pesticides. Text relevant to FIFRA is excerpted, with
minor modifications, from the corresponding chapter of CRS Report RL30798,
Environmental Laws: Summaries of Statutes Administered by the Environmental
Protection Agency, which summarizes more than a dozen environmental statutes.
This report will be updated at the beginning of the first session of each new
Congress, or sooner if Congress enacts a law that substantively changes a statute.
Congress enacted the original version of FIFRA in 1947, but a revision in 1972
is the basis of current pesticide policy. Substantial changes were made in 1988 and
again in 1996. The 1996 FIFRA amendments were contained in the Food Quality
Protection Act (FQPA), which also amended the FFDCA. Congress first required
limits on pesticide residues on raw food in 1954 amendments to the FFDCA. Limits
were required for food additives (including pesticide residues in processed foods) in
the 1958 FFDCA amendments. In the 1996 FFDCA amendments, Congress
established a new standard of safety for pesticide residues in food (both raw and
processed): maximum residue levels set by EPA must ensure with “a reasonable
certainty” that “no harm” will result from pesticide exposure.
FIFRA requires the U.S. Environmental Protection Agency (EPA) to regulate
the sale and use of pesticides in the United States through registration and labeling
of pesticide products. The sale of any pesticide is prohibited in the United States
unless it is registered and labeled. EPA is directed to restrict the use of pesticides as
necessary to prevent unreasonable adverse effects on people and the environment,
taking into account the costs and benefits of various pesticide uses. In addition,
FIFRA requires EPA to reregister older pesticides based on new data that meet
current regulatory and scientific standards. Pesticides manufactured solely for export
do not require registration. For pesticides to be registered for use in food production,
FFDCA Section 408 authorizes EPA to establish allowable residue levels, called
“tolerances,” that ensure that human exposure to pesticide residues in food will be
“safe.” Foods with pesticide residues above the tolerance, or for which there is no
tolerance established, may not be imported or sold in interstate commerce. A
pesticide may not be registered under FIFRA for a food use unless a tolerance for that
pesticide and food has been established under FFDCA.
FIFRA directs EPA to make public any data submitted to support a registration
application, if EPA registers the pesticide, but certain data are protected as trade
secrets, and other registrants may not use the same data to support registration
applications for similar pesticides for a period of 10 years. EPA continues to
evaluate the safety of pesticides after they are registered, as new information becomes
available. A pesticide registration may be canceled or amended if EPA determines
that current use may cause unreasonable adverse effects.

Contents
In troduction ..................................................1
Overview ....................................................1
History of Federal Pesticide Law..................................2
FIFRA ..................................................2
FFDCA ..................................................3
Registration of Pesticide Products.................................4
Tolerance Setting..............................................6
Public Disclosure, Exclusive Use, and Trade Secrets..................7
Reregistration .................................................8
Special Review................................................9
Canceling or Suspending a Registration............................9
Use of Unregistered Pesticides..................................10
Enforcement .................................................10
Export of Unregistered Pesticides................................10
Selected References...........................................12
List of Tables
Table 1. Federal Insecticide, Fungicide, and Rodenticide Act
and Amendments..............................................3
Table 2. Federal Food, Drug, and Cosmetic Act, Section 408,
and Amendments..............................................4
Table 3. Major U.S. Code Sections of the Federal Insecticide,
Fungicide, and Rodenticide Act..................................11
Table 4. Major U.S. Code Sections of the Federal Food, Drug,
and Cosmetic Act Related to Pesticides............................12

Pesticide Law: A Summary of the Statutes
Introduction
The Environmental Protection Agency (EPA) is responsible for implementing
federal pesticide policies under two statutes: the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA),¹ governing the sale and use of pesticide products within
the United States, and the Federal Food, Drug, and Cosmetic Act (FFDCA), which
limits pesticide residues on food in interstate commerce (including imports). This
report defines key terms, provides a brief history of the federal pesticide laws, and
describes key provisions of the laws, including the pesticide registration process and
how it interfaces with food safety requirements. In addition, this report lists several
references for more detailed information about the acts, and two tables cross
reference sections of the U.S. Code with corresponding sections of the acts. The
report is descriptive rather than analytic, highlights key provisions rather than
providing a comprehensive inventory of the acts’ numerous sections, and addresses
authorities and limitations imposed by statute, rather than the status of EPA
implementation or other policy issues. Other CRS products address current pesticide
issues, including CRS Report RL32218, Pesticide Registration and Tolerance Fees:
Overview, by Robert Esworthy.
Overview
There are an estimated 18,000 pesticide products currently in use.² These
generally are regulated under FIFRA, but approximately 5,800 pesticide products
used in food production also are regulated under the FFDCA, as discussed below.
FIFRA requires EPA to regulate the sale and use of pesticides in the United States
through registration and labeling.³ Pesticides are broadly defined in FIFRA Section
2(u) as chemicals and other products used to kill, repel, or control pests. Familiar
examples include pesticides used to kill insects and weeds that can reduce the yield,
and sometimes harm the quality, of agricultural crops, ornamental plants, forests,
wooden structures, and pastures. But the broad definition of “pesticide” in FIFRA
also applies to products with less familiar “pesticidal uses.” For example, substances
used to control mold, mildew, algae, and other nuisance growths on equipment, in
surface water, or on stored grains are pesticides. The term also applies to
disinfectants and sterilizing agents, animal repellents, rat poison, and many other
substances.

¹ FIFRA also is known as the Act of June 25, 1947.
² James L. Beech, U.S. EPA, Office of Pesticide Programs, personal communication,
November 20, 2006.
³ Exceptions are noted in 40 CFR 152.20, 152.25, and 152.30.

FIFRA directs EPA to restrict the use of pesticides as necessary to prevent
unreasonable adverse effects on people and the environment, taking into account the
costs and benefits of various pesticide uses. The act prohibits sale of any pesticide
in the United States unless it is registered and labeled to indicate approved uses and
restrictions. It is a violation of the law to use a pesticide in a manner that is
inconsistent with the label instructions. EPA registers each pesticide product for
each approved use. For example, a product may be registered for use on green beans
to control mites, as a seed treatment for cotton, and as a treatment for structural
cracks. In addition, FIFRA requires EPA to reregister older pesticides based on new
data that meet current regulatory and scientific standards. Establishments that
manufacture or sell pesticide products must register with EPA. Facility managers are
required to keep certain records and to allow inspections by federal or state regulatory
officials.
For the 600 or more pesticides (i.e., active ingredients) registered for use in food
production, the FFDCA Section 408 authorizes EPA to establish maximum allowable
residue levels (called tolerances) that ensure that human exposure to the pesticide
ingredients in food and animal feed will be “safe”.⁴ A “safe” tolerance is defined as
a level at which there is “a reasonable certainty of no harm” from the exposure.
Under FFDCA, foods with a residue of a pesticide ingredient for which there is no
tolerance established, or with a residue level exceeding an established tolerance limit,
are declared “unsafe” and “adulterated”; such foods cannot be sold in interstate
commerce or imported to the United States. Pesticides may not be registered under
FIFRA for use on food unless tolerances (or exemptions) have been established under
the FFDCA.
History of Federal Pesticide Law
Table 1 and Table 2 summarize the history of FIFRA and FFDCA, respectively.
FIFRA.Federal pesticide legislation was first enacted in 1910. It aimed to
reduce economic exploitation of farmers by manufacturers and distributors of
adulterated or ineffective pesticides. Congress did not address the potential risks to
human health posed by pesticide products until it enacted the original 1947 version
of FIFRA. The U.S. Department of Agriculture (USDA) was responsible for
administering the pesticide statutes during this period. However, responsibility was
shifted to the EPA when that Agency was created in 1970. Broader congressional
concerns about long- and short-term toxic effects of pesticide exposure on people
who applied pesticides (applicators), wildlife, nontarget insects and birds, and on
food consumers, subsequently led to a complete revision of FIFRA in 1972. The
1972 law completely replaced the original 1947 law, and is the basis of current
federal policy. Substantial changes were made in 1988 (P.L. 100-532), 1996 (P.L.

⁴ Ingredients in pesticide products are categorized as active or inert. Active ingredients are
those that are intended to control the pest, while inert ingredients are used to deliver the
active ingredients effectively to the pest. Inert ingredients often are solvents or surfactants
and often comprise the bulk of the pesticide product. Some inerts are known to be toxic, and
some are known to be harmless, but EPA lists most in the category “inerts of unknown
toxicity.”

104-170), and 2004 (P.L 108-199). The 1988 amendments focused on accelerating
the reregistration process. The 1996 amendments facilitated registration of pesticides
for special (so-called “minor”) uses, reauthorized collection of fees to support
reregistration, and required coordination of regulations implementing FIFRA and the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). The 2004
amendments, known as the Pesticide Registration Improvement Act (PRIA),
modified the types and amounts of fees that EPA could collect to support its
activities. The Pesticide Registration Improvement Renewal Act, or PRIA 2 (P.L.

110-94), enacted October 9, 2007, reauthorized and revised these fee provisions,

which would have expired at the end of FY2008. See Table 3 for a listing of current
provisions in FIFRA.
Authorization for appropriations for FIFRA expired on September 31, 1991,
although appropriations bills have continued to provide funding to implement the
law. Authority provided by FIFRA to EPA to issue and enforce regulations is, for the
most part, permanent, and is not affected by the lack of authorization.
Table 1. Federal Insecticide, Fungicide, and
Rodenticide Act and Amendments
^(codi^fⁱ^{ed g}^eⁿ^e^ral^l^y^as^{7 U}^.^S^.^C^.^136-^136y⁾
YearActPublic Law Number
1947Federal Insecticide, Fungicide, and Rodenticide ActP.L. 80-104
1964Federal Insecticide, Fungicide, and Rodenticide ActP.L. 88-305
Amendments
1972Federal Environmental Pesticide Control ActP.L. 92-516
1975Federal Insecticide, Fungicide, and Rodenticide ActP.L. 94-140
Extension
1978Federal Pesticide Act of 1978P.L. 95-396
1980Federal Insecticide, Fungicide and Rodenticide ActP.L. 96-539
Amendments
1988Federal Insecticide, Fungicide, andP.L. 100-532
Rodenticide Amendments of 1988
1990Food, Agriculture, Conservation, andP.L. 101-624
Trade Act of 1990
1991Food, Agriculture, Conservation and TradeP.L. 102-237
Amendments of 1991
1996Food Quality Protection Act (FQPA) of 1996P.L. 104-170
2004Pesticide Registration Improvement Act of 2003P.L. 108-199
2007Pesticide Registration Improvement Renewal ActP.L. 110-94
^Source:^C^oⁿ^g^r^es^sⁱ^on^{al R}^e^s^earch^Serv^ice.
^Note:^T^h^{e cu}^rren^{t F}^I^F^R^A^s^t^atu^t^{e w}^a^s^es^tablis^h^e^{d by}^P^.^L^.^92-^{516, w}^h^ich^com^p^l^e^t^e^ly^{replaced (by}
^am^en^dm^en^t⁾^t^h^{e ori}^gⁱⁿ^al^{1947 l}^e^gⁱ^s^l^atⁱ^oⁿ^.
FFDCA. The original Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA)
established the structure of the current law. With respect to food safety and possible
contaminants, it required the Food and Drug Administration (then a part of the U.S.

Department of Agriculture) to set maximum residue levels (tolerances) for
unavoidable poisonous substances in food. Congress acted to protect consumers
from pesticide residues on food in 1954 by adding a new Section 408 to the FFDCA.
It directed FDA to set residue tolerances for all pesticides in raw agricultural
commodities. Congress expanded the requirement for tolerances in the Food
Additives Amendment of 1958, which added Section 409, directing FDA to set
tolerances for food additives, including pesticide residues in processed foods.
Section 409 also forbade the addition to food of any additive (including pesticide
residue), if it was found to be a potential cancer-causing agent. This provision is
referred to as the Delaney Clause.
In 1970, authority to establish tolerances for pesticide residues was transferred
to the newly formed EPA. FDA (now in the Department of Health and Human
Services) retained responsibility for enforcement of tolerances in food that is
imported or sold across state boundaries.
In 1996, Congress substantially revised requirements for pesticide residue
tolerance setting in the Food Quality Protection Act (FQPA). The FQPA redefined
terms so that pesticide residues in processed foods were no longer regulated as food
additives, and therefore no longer were subject to the Delaney Clause. The FQPA
also established a new safety standard of a “reasonable certainty of no harm” from
exposure to pesticides. See Table 4 for a listing of current pesticide-related
provisions in FFDCA.
The Act of July 22, 1954, authorized such sums as may be necessary to carry
out this FFDCA section (21 U.S.C. 346b).
Table 2. Federal Food, Drug, and Cosmetic Act, Section 408,
and Amendments
(codified generally as 21 USC 346a)
YearActPublic Law Number
1938Federal Food, Drug, and Cosmetic ActAct of June 25, 1938
1954Federal Food, Drug, and Cosmetic ActAct of July 22, 1954
Amendments
1958Food Additive Amendments of 1958P.L. 85-929
(including the Delaney Clause)
1996Food Quality Protection Act of 1996P.L. 104-170
^Source:^C^oⁿ^g^r^es^sⁱ^on^{al R}^e^s^earch^Serv^ice.
Registration of Pesticide Products
When pesticide manufacturers apply to register a pesticide active ingredient,
pesticide product, or a new use of a registered pesticide under FIFRA Section 3, EPA
requires them to submit scientific data on toxicity and behavior in the environment.
EPA may require data from any combination of more than 100 different tests,
depending on the potential toxicity of active and inert ingredients and degree of

exposure. To register a pesticide use on food, EPA also requires applicants to
identify analytical methods that can be used to test food for residues of active
ingredients, certain inert ingredients, and their breakdown products and to determine
the amount of residue that could remain on crops, as well as on (or in) food products,
assuming that the pesticide product is applied according to the manufacturers’
recommended rates and methods.
Based on the data submitted, EPA determines whether and under what
conditions the proposed pesticide use would present an unreasonable risk to human
health or the environment. If the pesticide is proposed for use on a food crop, EPA
also determines whether a “safe” level of pesticide residue, called a “tolerance,” can
be established under the Federal Food, Drug, and Cosmetic Act. A tolerance must
be established before a pesticide registration may be granted for use on food crops.
If registration is granted, the Agency specifies the approved uses and conditions of
use, including safe methods of pesticide storage and disposal, which the registrant
must explain on the product label. FIFRA requires that federal regulations for
pesticide labels pre-empt state, local, and tribal regulations. Use of a pesticide
product in a manner inconsistent with its label is prohibited.
EPA may classify and register a pesticide product for general or for restricted
use. Products known as “restricted-use pesticides” are those judged to be more
dangerous to the applicator or to the environment. Such pesticides can be applied
only by people who have been trained and certified. Individual states and Indian
tribes generally are responsible for training and certifying pesticide applicators.
FIFRA Section 3 also allows “conditional,” temporary registrations if (1) the
proposed pesticide ingredients and uses are substantially similar to currently
registered products and will not create additional significant environmental risks; (2)
an amendment is proposed for additional uses of a registered pesticide, and sufficient
data are submitted indicating that there is no significant additional risk; or (3) data
requirements for a new active ingredient require more time to generate than normally
allowed, and use of the pesticide during the period will not cause any unreasonable
adverse effect on the environment and will be in the public interest.

FIFRA-FFDCA Coordination
EPA has long coordinated pesticide registrations for food uses under FIFRA with
tolerance setting under the FFDCA. The Food Quality Protection Act of 1996
(FQPA; Public Law 104-170) codified this policy. Thus, if EPA revokes a residue
tolerance under FFDCA, it cancels the FIFRA pesticide registration for that food
use. Similarly, if a pesticide registration for use on a food crop is canceled, EPA
also cancels the residue tolerance for the food. However, just as FIFRA allows
continued use of remaining pesticide stocks after a registration is canceled,
FFDCA allows continued commerce in commodities legally treated with a
pesticide. Thus, EPA does not immediately revoke the tolerance for the pesticide
residue, when it cancels the corresponding registration.

Tolerance Setting
Any person who has registered a pesticide may petition EPA proposing
establishment of a tolerance or an exemption for that pesticide to permit its use on
food-related crops.⁵ Tolerance petitions must include information about pesticide
application rates, measured concentrations of pesticide residues on the food after the
pesticide has been applied according to directions on its label, and safety of pesticide
use on food crops. The FFDCA requires EPA to respond to each petition by
establishing a tolerance or exempting the pesticide from the requirement. If the
pesticide will not leave residues above an established safe level, EPA will register the
pesticide for use on that food product and set the tolerance level by issuing a
regulation. EPA tolerances for pesticide residues preempt state and local restrictions
on food, if the state and local restrictions are based on lower residue levels. States
may petition for an exception if the EPA-set residue level threatens public health.
The FFDCA, Section 408, as amended, requires EPA to assess safety in terms
of total exposure to the pesticide (that is, to the concentration of pesticide allowed by
the tolerance, together with all other dietary and non-food exposures for which there
is reliable information) as well as to other pesticides that have the same toxic effects
on people. No quantitative standard of safety is established by law, but the
Committee on Commerce noted in its report on the bill that became the FQPA that
EPA should continue setting standards to ensure safety as it had in the past:
... the Committee expects that a tolerance will provide a ‘reasonable certainty of
no harm’ if the Administrator determines that the aggregate exposure to the
pesticide chemical residue will be lower by an ample margin of safety than the
level at which the pesticide chemical residue will not cause or contribute to any
known or anticipated harm to human health. The Committee further expects,
based on discussions with the Environmental Protection Agency, that the
Administrator will interpret an ample margin of safety to be a 100-fold safety
factor applied to the scientifically determined ‘no observable effect’ level when⁶
data are extrapolated from animal studies.
In determining a safe level, the FFDCA directs EPA to take into account many
factors, including available information on dietary exposure to pesticides among
infants and children. FQPA strictly limited the nature and influence of benefits
considered in tolerance setting under Section 408 of the FFDCA. As amended,
Section 408 allows EPA to maintain or modify existing tolerances (but not to
establish new tolerances) at higher than “safe” residue levels only if the pesticide use
avoids other greater risks to consumers, or is necessary to avoid significant disruption
in domestic production of an adequate, wholesome, and economical food supply.
Such higher tolerance levels may be set only for pesticides that are potential
carcinogens (or have some other health effect) for which there is no known level of
exposure at which no harm is anticipated (known as a non-threshold effect). The

⁵ That is, use on food crops, animal feed crops, or food products directly (e.g., grains, fruits,
or vegetables after harvest).
⁶ U.S. House of Representatives, Committee on Commerce, Food Quality Protection Act of

1996, H.Rept. 104-669, part 2, 104^th Cong., 2^nd sess, 1996, p. 6.

higher tolerance level allowed for such pesticide residues must be “safe” for infants
and children, as well as with respect to health effects for which there is a known
threshold (that is, a level below which exposure is known to be harmless). The
higher cancer (or other non-threshold) risk posed by the tolerance on an annual basis
may not be more than 10 times the risk at a “safe” level of exposure and not more
than twice the risk of a “safe” level over a lifetime.
For nonthreshold effects, the House Commerce Committee provided additional
guidance for establishing a level of residue that should be considered “safe.”
In the case of a nonthreshold effect which can be assessed through quantitative
risk assessment, such as a cancer effect, the Committee expects, based on its
understanding of current EPA practice, that a tolerance will be considered to
provide a ‘reasonable certainty of no harm’ if any increase in lifetime risk, based
on quantitative risk assessment using conservative assumptions, will be no
greater than ‘negligible.’ It is the Committee’s understanding that, under current
EPA practice, ... EPA interprets a negligible risk to be a one-in-a-million lifetime
risk. The Committee expects the Administrator to continue to follow this⁷
interpretation.
The “safe” standard applies to both raw and processed foods, and requires EPA to
consider cumulative and aggregate exposure to pesticides in food, drinking water, air,
and consumer products. Congress directed EPA to reevaluate all existing tolerances
against this standard before August 2006.
FFDCA directs the FDA in the Department of Health and Human Services and
USDA to monitor pesticide residue levels in food in interstate commerce and to
enforce tolerances through their food inspection programs. USDA is responsible for
inspecting meat and poultry; FDA inspects all other foods. States also may monitor
pesticide residues in food sold within their jurisdictions.
Public Disclosure, Exclusive Use, and Trade Secrets
FIFRA Section 3 directs EPA to make the data submitted by the applicant for
pesticide registration publicly available within 30 days after a registration is granted.
However, applicants may claim certain data are protected as trade secrets under
FIFRA, Section 10. If EPA agrees that the data are protected, the Agency must
withhold those data from the public, unless the data pertain to the health effects or
environmental fate or effects of the pesticide ingredients. Information may be
protected if it qualifies as a trade secret and reveals: (1) manufacturing processes; (2)
details of methods for testing, detecting, or measuring amounts of inert ingredients;
or (3) the identity or percentage quantity of inert ingredients.
Companies sometimes seek to register a product based upon the registration of
similar products, relying upon the data provided by the original registrant that are
publicly released. This is allowed. However, Section 3 of FIFRA provides for a 10-
year period of “exclusive use” by the registrant of data submitted in support of an
original registration or a new use. In addition, an applicant who submits any new

⁷ Ibid.

data in support of a registration is entitled to compensation for the cost of data
development by any subsequent applicant who supports an application with that data
within 15 years of its submission. If compensation is not jointly agreed upon by the
registrant and applicant, binding arbitration can be invoked.
Reregistration
Most pesticides currently registered in the United States are older pesticides and
were not subject to modern safety reviews. Amendments to FIFRA in 1972 directed
EPA to “reregister” approximately 35,000 older products, in order to assess their
safety in light of current standards. The task of reregistering older pesticides was
streamlined by reviewing groupings of products having the same active ingredients,
on a generic instead of individual product basis. For food-use pesticides, EPA
evaluated a pesticide’s eligibility for reregistration at the same time the Agency
reassessed the tolerance for that pesticide under the FFDCA. The FQPA required
EPA to reassess pesticides posing the greatest risks first. Many of the 35,000
pesticide products were not reviewed and their registrations were canceled, because
registrants did not request reregistration. At least 14,000 products are no longer in
use. Nevertheless, the task for registrants and EPA was immense and costly.
To accelerate the process of reregistration, Congress, in 1988 amendments to
FIFRA, imposed a 10-year reregistration schedule. To help pay for the additional
costs of the accelerated process, Congress directed EPA to require registrants to pay
reregistration and annual registration maintenance fees on pesticide ingredients and
products. The 1996 amendments to FIFRA extended EPA’s authority to collect
maintenance fees through FY2001. Exemptions from, or reductions in, fees were
allowed for minor-use pesticides, public health pesticides, and small business
registrants. Congress extended authority for fees annually through appropriations
legislation after FY2001, until the omnibus appropriations legislation signed January
23, 2004 (P.L. 108-199) modified the types and amounts of fees that EPA could
collect, potentially through FY2008.
The 2004 FIFRA amendments (PRIA) reauthorized collection of annual
“maintenance” fees to support registration, designated a portion of those fees for the
review of inert ingredients, and extended the deadline for completion of
reregistration. PRIA directed EPA to complete Reregistration Eligibility Decisions
(REDs) for pesticides with food uses/tolerances by August 3, 2006, and to complete
REDs for all remaining non-food use pesticides by October 3, 2008. The
reregistration process will continue for several years after that date, as explained on
the EPA reregistration website:
After EPA has issued a RED and declared a pesticide eligible for reregistration,
individual end-use products that contain the pesticide active ingredient still must
be reregistered. Through this concluding part of the process, known as “product
reregistration,” the Agency makes sure that the risk reduction measures called for
in REDs are reflected on individual pesticide product labels. In some cases, the
Agency uses Memoranda of Agreement or other measures to include risk
reduction measures on pesticide labels sooner, before product reregistration is

completed. EPA plans to complete the last product reregistration decisions⁸
several years after the last REDs are signed.
EPA authority for administering these fees would have expired at the end of FY2008,
but it was extended by the Pesticide Registration Improvement Renewal Act, or
PRIA 2 (P.L. 110-94), enacted October 9, 2007, effective retroactively to the
beginning of FY2008 through FY2012. PRIA 2 also made some technical revisions,
primarily modifications to the fee payment process and an expansion of the range of
categories of pesticide registration (licensing) activities subject to fees.
Special Review
EPA continues to evaluate the safety of pesticides after they are registered as
new information becomes available. FIFRA requires registrants to report promptly
any new evidence of adverse effects from pesticide exposure. If evidence indicates
that a registered pesticide may pose an unreasonable risk, EPA may initiate a special
review of available information to reevaluate the risks and benefits of each registered
use. FIFRA also authorizes EPA to require registrants to conduct new studies to fill
gaps in scientific understanding to assist risk assessments. As a result of a special
review EPA may conclude that registration is adequate, needs amendment, or should
be canceled.
Canceling or Suspending a Registration
If a special review or reregistration evaluation finds that a registered use may
cause “unreasonable adverse effects,” EPA may amend or cancel the registration.⁹
FIFRA also allows registrants to request cancellation or amendment of a registration
to terminate selected pesticide uses. Requesting voluntary cancellation sometimes
reflects a registrant’s conclusion that the cost of additional studies is not worth the
expected benefit (that is, profit) from sales if the registration would be maintained.
If a registration is canceled for one or more uses of a pesticide, FIFRA does not
permit it to be sold or distributed for those uses in the United States, although for a
specified period of time, U.S. farmers may use remaining stocks, and commerce may
continue for commodities that were legally treated with the pesticide. FIFRA allows
registrants to appeal an EPA decision to cancel a registration. An appeal initiates a
lengthy review process during which the product may continue to be marketed.
However, if there is threat of an “imminent hazard” during the time required to
cancel a registration, FIFRA authorizes EPA to suspend registration. Suspension
orders, which also may be appealed, stop sales and use of the pesticide. In the event
of suspension and cancellation, FIFRA Section 15 directs EPA to request an
appropriation from Congress to compensate anyone who owned any of the pesticide
and suffered any loss due to the suspension or cancellation. The registrant of the

⁸ EPA. Pesticide Reregistration Facts. October 26, 2006.
[http://www.epa.gov/oppsrrd1/reregistration/reregistration_facts.htm], visited November 20,

2006.

⁹ Registrations also may be canceled under other conditions, for example, if data are not
submitted in response to EPA’s request for additional information to maintain a registration
or if a registrant fails to pay the maintenance fee.

suspended and canceled product is responsible, however, for all of the transportation
and disposal costs, and most storage costs.
Use of Unregistered Pesticides
FIFRA also allows for unregistered use of pesticide products in special
circumstances. Section 5 allows experimental use permits for purposes of research
and to collect data needed to register a pesticide. Section 18 allows “emergency
exemptions” from the provisions of FIFRA to be granted to federal or state agencies,
for example, if there is a virulent outbreak of a disease that cannot be controlled by
registered products. In addition, Section 24(c) permits states to allow additional uses
of a federally registered product to meet “special local needs.”
Enforcement
Generally, EPA has the authority to enforce FIFRA requirements. However,
FIFRA Section 26 gives states with adequate enforcement procedures, laws, and
regulations primary authority, including inspection authority, for enforcing FIFRA
provisions related to pesticide use. EPA is authorized by Section 27 to rescind a
state’s primary enforcement responsibility if it is not being carried out.
FIFRA Section 11 authorizes EPA to form cooperative agreements with states,
giving them the responsibility for training and certifying applicators of restricted use
pesticides. States also may initially review and give preliminary approval to
applications for emergency exemptions and special local needs registrations,
(although under some conditions FIFRA allows EPA later to deny state-approved
applications).
Section 9 authorizes inspections by EPA and authorized state officials of
pesticide products where they are stored for distribution or sale. Section 13
authorizes EPA to issue orders to stop sales and to seize supplies of pesticide
products. Civil and criminal penalties for violations of FIFRA are established in
Section 14, while Section 15 provides indemnity payments for end users, distributors,
and dealers of pesticides when registrations are suspended and canceled.
Federal district courts are authorized in Section 16 to review EPA final actions
and omissions when action is not discretionary. People adversely affected by an EPA
order may file for judicial review of the order following a hearing. But, FIFRA does
not authorize citizen suits against violators.
Export of Unregistered Pesticides
FIFRA does not give EPA the authority to regulate domestic production for
export of unregistered pesticides, even if U.S. registration has been canceled for
health or environmental reasons. However, FIFRA does require exporters to prepare
or pack pesticides as specified by the purchaser and in accord with some of the
FIFRA labeling provisions. For example, exporters must translate warning
information into the language of the destination. FIFRA also requires exporters of
unregistered pesticides to obtain the purchaser’s signature on a statement
acknowledging that the pesticide is unregistered and cannot be sold in the United

States. EPA is required to notify governments of other countries and international
agencies whenever a registration, cancellation, or suspension of any pesticide
becomes or ceases to be effective in the United States.
Table 3. Major U.S. Code Sections of the Federal Insecticide,
Fungicide, and Rodenticide Act
^(codi^fⁱ^{ed g}^eⁿ^e^ral^l^y^as^{7 U}^.^S^.^C^.^136-^136y⁾
7 U.S.C.Section TitleFIFRA
Short title and table of contentssec. 1
136Definitionssec. 2
136aRegistration of pesticidessec. 3
136a-1Reregistration of registered pesticidessec. 4
136cExperimental use permitssec. 5
136dAdministration review; suspensionsec. 6
136eRegistration of establishmentssec. 7
136fBooks and recordssec. 8
136gInspection of establishmentssec. 9
136hProtection of trade secrets and other informationsec. 10
136iRestricted use pesticides; applicatorssec. 11
136jUnlawful actssec. 12
136kStop sale, use, removal, and seizuresec. 13
136lPenaltiessec. 14
136mIndemnitiessec. 15
136nAdministrative procedure; judicial reviewsec. 16
136oImports and exportssec. 17
136pExemption of federal and state agenciessec. 18
136qStorage, disposal, transportation, and recallsec. 19
136rResearch and monitoringsec. 20
136sSolicitation of comments; notice of publicsec. 21
hearings
136tDelegation and cooperationsec. 22
136uState cooperation, aid, trainingsec. 23
136vAuthority of statessec. 24
136wAuthority of Administratorsec. 25
136w-1State primary enforcement responsibilitysec. 26
136w-2Failure by the state to assure enforcement ofsec. 27
state pesticide use regulations
136w-3Identification of pests; cooperation withsec. 28
Department of Agriculture’s program
136w-4Annual reportsec. 29
136w-5Minimum requirements for training ofsec. 30
maintenance applicators and service technicians
136w-6Environmental Protection Agency minor usesec. 31
program
136w-7Department of Agriculture minor use programsec. 32
136w-8Pesticide Registration Service Feessec. 33
136xSeverabilitysec. 33
136yAuthorization of Appropriationssec. 34
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Table 4. Major U.S. Code Sections of the Federal Food, Drug,
and Cosmetic Act Related to Pesticides
^(codi^fⁱ^{ed g}^eⁿ^e^ral^l^y^as^{21 U}^.^S^.^C^.^321-^346a)
21 U.S.C.Section TitleFFDCA
Chapter II — Definitions
321Definitionssec. 201
Chapter III — Prohibited Acts and Penalties
331Prohibited actssec. 301
332Injunction proceedingssec. 302
333Penaltiessec. 303
334Seizuresec. 304
Chapter IV — Food
342Adulterated foodsec. 402
343Misbranded foodsec. 403
346Tolerances for poisonous ingredients in foodsec. 406
346aTolerances and exemptions for pesticidesec. 408
chemical residues

346a(a)Requirement for tolerance or exemptionsec. 408(a)

346a(b)Authority and standard for tolerancesec. 408(b)

346a(c)Authority and standard for exemptionssec. 408(c)

346a(d)Petition for tolerance or exemptionsec. 408(d)

346a(e)Action on Administrator’s own initiativesec. 408(e)

346a(f)Special data requirementssec. 408(f)

346a(g)Effective data, objections, hearings, andsec. 408(g)

administrative review

346a(h)Judicial reviewsec. 408(h)

346a(i)Confidentiality and use of datasec. 408(i)

346a(j)Status of previously issued regulationssec. 408(j)

346a(k)Transitional provisionsec. 408(k)

346a(l)Harmonization with action under other lawssec. 408(l)

346a(m)Feessec. 408(m)

346a(n)National uniformity of tolerancessec. 408(n)

346a(o)Consumer right to knowsec. 408(o)

346a(p)Estrogenic substances screening programsec. 408(p)

346a(q)Schedule for reviewsec. 408(q)

346a(r)Temporary tolerance or exemptionsec. 408(r)

346a(s)Savings clausesec. 408(s)

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Selected References
Bergeson, Lynn L. FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act).
Basic Practice Series. American Bar Association. 2000. 150 p.
CRS Report 96-759, Pesticide Legislation: Food Quality Protection Act of 1996
(P.L. 104-170), by Linda-Jo Schierow.
CRS Report RL32218, Pesticide Registration and Tolerance Fees: Overview, by
Robert Esworthy.