Pesticide Legislation: Food Quality Protection Act of 1996 (P.L. 104-170)

Pesticide Legislation: Food Quality Protection Act of 1996 (P.L. 104-170)

96-759 ENR
CRS Report for Congress
Received through the CRS Web
Pesticide Legislation:
Food Quality Protection Act of 1996
(P.L. 104-170)
Updated September 11, 1998
(name redacted)
Specialist in Environmental Policy
Environment and Natural Resources Policy Division
Congressional Research Service ˜ The Library of Congress

ABSTRACT
This report summarizes the Food Quality Protection Act of 1996 (FQPA), enacted by the
104th Congress as Public Law 104-170. It also analyzes issues in the regulation of pesticide
sales and use and the potential impact of FQPA amendments to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act
(FFDCA). Appendix A briefly describes the authorities and provisions of the FIFRA and
FFDCA, as amended by FQPA. Appendix B provides a section-by-section summary of
Public Law 104-170. This report will not be updated.

Pesticide Legislation: Food Quality Protection Act of 1996
(P.L. 104-170)
Summary
The 104th Congress enacted significant changes to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), governing U.S. sale and use of pesticide
products, and the Federal Food, Drug, and Cosmetic Act (FFDCA), which limits
pesticide residues on food. The vehicle of these changes was H.R. 1627, the “Food
Quality Protection Act of 1996" (FQPA), enacted August 3, 1996, as P.L. 104-170.
Under FIFRA, the new law will facilitate registrations and reregistrations of
pesticides for special (so-called “minor”) uses and authorize collection of
maintenance fees to support pesticide reregistration. Coordination of regulations
implementing FIFRA and FFDCA will be required. Food safety provisions will
establish a single standard of safety for pesticide residue on raw and processed foods;
provide information through large food retail stores to consumers about the health
risks of pesticide residues and how to avoid them; preempt state and local food safety
laws if they are based on concentrations of pesticide residues below recently
established federal residue limits (called “tolerances”); and ensure that tolerances
protect the health of infants and children.
Contrary to widespread reports, the FQPA does not repeal the Delaney Clause
or amend FFDCA Section 409: food additives that are not pesticide residues remain
subject to the “zero-risk” Delaney standard. Rather, P.L. 104-170 eliminated the
distinction between raw and processed food tolerances so that all pesticide residues
will be regulated under an amended FFDCA Section 408. New Section 408 requires
all tolerances to be “safe,” ensuring a “reasonable certainty of no harm” from
pesticides. It authorizes slightly higher residue concentrations on foods when
pesticide use avoids greater health risks to consumers or significant disruptions to
domestic production of an adequate, wholesome, and economical food supply.
The FQPA, as enacted, does not address two issues that were addressed by H.R.
1627, as introduced and reported in the House, but were deleted before the House and
Senate debates. The FQPA does not include a proposal to federally preempt local
pesticide use regulations which was opposed by several states with laws either
authorizing or preempting local regulation. The FQPA also omits a provision
opposed by Indian tribes and the Administration that would have prohibited tribal
enforcement of pesticide use laws on land within tribal boundaries if less than half
that land were owned by the tribe or tribal members.
The FQPA has widespread support in the community of growers, food
processors, chemical suppliers, environmental and consumer advocacy groups, and
state government agriculture officials. The Clinton Administration also generally
supports its provisions.
For readers not familiar with the statutes, Appendix A describes key FIFRA and
FFDCA authorities and provisions. Appendix B provides a brief section-by-section
summary of P.L. 104-170.

Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Key Issues Addressed by the Food Quality
Protection Act of 1996 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Pesticide Use Provisions and Amendments to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) . . . . . . . . . . . . . . . . . . . . . . . 2
Expediting Suspensions of Registration for Imminent Hazards . . . . . . 2
Training Pesticide Applicators in Urban and Suburban Areas . . . . . . . 2
Facilitating Minor Use Registration and Reregistration . . . . . . . . . . . . 3
Coordinating FIFRA and FFDCA Regulations for Food-Use Pesticides . . . 5
Food Safety Provisions and Amendments to the Federal Food, Drug, and
Cosmetic Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Protecting Infants and Children from Pesticide Residues in the Diet . . 8
Revising Tolerance-Setting Criteria for Pesticide Residues in Food . . 10
Preempting State Pesticide Residue Tolerances . . . . . . . . . . . . . . . . . 14
Harmonizing U.S. Tolerances with International Standards . . . . . . . . 15
Issues Considered and Dropped Prior to Passage . . . . . . . . . . . . . . . . . . . . . . . . 16
Preempting State, Tribal, and Local Pesticide Use Laws . . . . . . . . . . . . . . 16
Clarifying and Limiting Tribal Pesticide Enforcement . . . . . . . . . . . . . . . . 16
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Congressional Hearings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Appendix A. Authorities and General Provisions of
Pesticide Laws, as Amended by the FQPA . . . . . . . . . . . . . . . . . . . . . . . A-1
FIFRA Authority and General Provisions . . . . . . . . . . . . . . . . . . . . . . . . A-1
FFDCA Authority and General Provisions . . . . . . . . . . . . . . . . . . . . . . . A-2
Appendix B. Section-by-Section
Summary of P.L. 104-170 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Pesticide Legislation: Food Quality Protection
Act of 1996 (P.L. 104-170)
Introduction
The 104th Congress enacted significant changes to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), governing the U.S. sale and use of
pesticide products, and to the Federal Food, Drug, and Cosmetic Act (FFDCA),
which limits pesticide residues on food in interstate commerce. The vehicle of these
changes was H.R. 1627, the “Food Quality Protection Act of 1996" (FQPA), enacted
August 3, 1996 as Public Law 104-170. This report summarizes and analyzes
provisions of the new law. It also describes key provisions in the bill as reported in
the House that were omitted prior to debate on the House floor and markup in the
Senate.
In general, key FIFRA issues revolved around: the roles of state, local, and
tribal governments in pesticide regulation and federal law enforcement; the cost of
scientific tests required by the U.S. Environmental Protection Agency (EPA) to
support pesticide registration and reregistration, and delays in processing applications
for new or amended registrations, especially for minor uses; and long delays in
reregistration of older pesticides and the need for fees to support the effort. A lesser
issue involved state authority to require training of persons who regularly apply non-
restricted pesticides in urban and suburban areas.
In this context, congressional concerns about FFDCA centered on the so-called
“zero-risk” standard of Section 409 (the Delaney Clause) for concentrated residues
in processed foods of pesticides that produce cancer in experimental animals. There
also were generally recognized needs for better data on risks to infants and children
from pesticide residues on food; coordination of tolerance revocations with pesticide
food-use cancellation; and increased monitoring of food imports for pesticide
residues. Other issues included a proposal for federal preemption of state and local
authority to impose requirements on food with pesticide residues that are not unsafe
based on federal law and EPA adoption of international residue standards.
All of these issues were addressed in H.R. 1627, as introduced; provisions
related to pesticide use were approved, amended, in May 1995 by a subcommittee of
the House Agriculture Committee. The full Committee further amended and reported
the bill in July 11, 1996. Food safety provisions were referred to the House
Commerce Committee, which reported July 23, 1996 (H.Rept. 104-669, Parts I and
II). The bill was further amended after being reported in the House but prior to
House debate and passage July 23, 1996. The Senate Committee on Agriculture,
Nutrition, and Forestry incorporated House-passed language as a substitute for the

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provisions of S. 1166, and the Senate passed H.R. 1627 the same night, July 24,
1996. The FQPA was amended after it was reported but before it was debated and
passed in the House and referred to the Senate. This amended FQPA omitted
provisions that were controversial in the House-reported bill that would have
preempted local pesticide use ordinances and prohibited tribal enforcement of
pesticide use laws within reservation boundaries.
Key Issues Addressed by the Food Quality
Protection Act of 1996
In the following text, analysis of provisions related to pesticide uses, including
amendments to FIFRA, precedes analysis of food safety provisions and FFDCA
amendments. Within this framework, issues are considered roughly in the order they
are treated in the FQPA.
Pesticide Use Provisions and Amendments to the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Expediting Suspensions of Registration for Imminent Hazards. Cancelling
a pesticide registration, when it is found to cause “unreasonable adverse effects,” can
be a prolonged process, lasting 4 to 8 years or more. To prevent an “imminent
hazard” during this period, EPA can suspend registration — meaning that use of the
pesticide is immediately prohibited — but not before EPA has published, or
provided the registrant with, a notice of its intention to cancel the registration.
Before the FQPA, FIFRA allowed EPA in an emergency to issue a suspension order
at the same time it proposed to cancel or change a registration, and the suspension
could become final after 30 days. However, the Clinton Administration wanted to
allow suspensions in cases of “imminent hazard” before any cancellation action.
Others, such as the National Association of State Departments of Agriculture
(NASDA), which represents the 54 leading public officials for agricultural policy in
each state and territory, found the existing authority adequate.
Public Law 104-170 allows EPA to issue a suspension order in an emergency,
before issuing a notice that it intends to cancel a registration or to change a
classification of the pesticide, but the suspension order will expire after 90 days if
EPA does not provide notice by that time.
Training Pesticide Applicators in Urban and Suburban Areas. While not
a particularly large proportion of total pesticide use by volume, household and
business uses of pesticides in urban and suburban settings may lead to exposure of
larger and more diverse populations than in agricultural applications. Concerns about
such exposures include immediate toxic reactions in sensitive individuals, as well as
less visible but longer-term health effects such as cancer. Pesticides that end up in
rivers, lakes, and groundwater are considered a significant water pollution problem.
This can result from excessive and improper application or improper disposal of
pesticide containers, for example. While these concerns apply to agricultural
applications as well, urban/suburban uses are sometimes at higher concentrations and
may be applied by persons unfamiliar with risks or proper application practices.

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Moreover, when pesticides are applied to lawns and gardens, golf courses, roadsides,
public buildings, apartment buildings, and single-family homes, the people exposed
may be very young or elderly and in robust or fragile health. People may be exposed
to pesticides in such settings unknowingly or at least without prior warning, as for
example, when entering a recently treated roadside area or public building.
Concerns about routine applications of pesticides in urban and suburban areas
have led to calls for training of “maintenance applicators” of unrestricted pesticides,
such as janitors, general maintenance personnel, sanitation personnel, and grounds
maintenance personnel. (Applicators of restricted pesticides already must be trained.)
The FQPA, Title I, Subtitle B adds a new section to FIFRA authorizing, but not
requiring, states to establish minimum requirements for training of maintenance
pesticide applicators and any individual who uses or supervises the use of pesticides
not classified for restricted use for the purpose of providing structural pest control or
lawn pest control on the property of another for a fee. Any training provided must
include instruction in the safe and effective handling and use of pesticides in
accordance with EPA-approved labels and in integrated pest management techniques.
Requirements do not apply to government employees, individuals who use
antimicrobial pesticides, private (e.g., household) use of pesticides, or any use of
ready-to-use consumer products. The bill authorizes EPA only to inform states about
the provisions of this subtitle.
Facilitating Minor Use Registration and Reregistration. According to
experts, about 1000 pesticide use registrations important to the agricultural
community for low-acreage, specialty crops (so-called “minor” agricultural uses) may
be canceled rather that reregistered.1 Another 2,600 new minor-use registrations
would be submitted through FY1997 to meet new pest control needs or to replace
disappearing minor-use registrations.2 Without such registrations, production of
many fruit, nut, and vegetable crops might be more costly, result in lower quality, and
diminish availability to consumers. Any loss in productivity could have a detrimental
economic impact on agricultural interests, and possibly an adverse impact on
consumer nutrition. About $35 billion in fruit, vegetable, and other specialty crops
are produced annually in the United States (20% of total farm receipts, 42% of total
crop receipts). Some farmers also believe the loss of minor-use pesticide products
will put them at a competitive disadvantage with foreign producers who would
continue to have access to the pesticides.
Although producers sometimes may cancel a registration because they fear
complete safety testing will reveal an unreasonable risk from the pesticide use, the
more common obstacle to maintaining the availability of pesticides for minor uses
is economic: for some pesticides the markets are not large enough to economically
justify the testing costs of maintaining minor-use registrations. These problems
persist despite amendments to FIFRA in the 1990 farm bill (Public Law 101-624)
which: eliminated a requirement for field residue data — the data most often lacking
for minor food uses — for minor use pesticides in geographic areas where the
1Pesticides: Minor Uses/Major Issues. Council for Agricultural Science and Technology.
Ames, Iowa, 1992. P. 3, 5.
2Ibid.

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pesticide would not be registered for use; authorized EPA to reduce or waive the fee
for a minor use pesticide registration; required public notice of voluntary registration
cancellations and established a grace period to transfer registrations for minor use
pesticides to new registrants; and authorized research that emphasized minor or local
pests.
EPA would like to expedite procedures for registering minor-use pesticides.
The Agency claims that it is now doing as much as possible administratively under
FIFRA to expedite the process of minor-use approval. Concerned growers have
organized the Minor Crop Farmers Alliance to seek legislative remedies. One of
their goals is to increase federal funding through such programs as the USDA
interregional project (IR-4) for data collection in support of minor-use registration.
The FQPA, Title II, Subtitle A, addresses minor uses of pesticides. All interest
groups as well as EPA backed these provisions. In support of minor-use registrations
and reregistrations, the FQPA will:
! extend time periods allowed for submissions of pesticide residue chemistry
data;
! authorize EPA to waive data requirements for minor-use pesticides;
! direct EPA to expedite processing of complete minor-use registration
applications;
! temporarily extend registration for 180 days, rather than the current 90 days,
to provide additional time for registrants who do not support continued
registration of a minor use to arrange transfer of the registration to another
producer;
! facilitate registration transfers;
! establish a program in EPA to coordinate its minor use pesticide activities;
! require USDA to coordinate its minor use pesticide activities; and
! establish and authorize funding for a minor use grant program to develop
required data.
The FQPA also extends the period of exclusive use — that is, the years during
which no one but the original registrant may use the safety data — for registrants of
minor uses. This will provide more time for the registrant to recover costs and make
a profit. The current 10-year period of exclusive use is expanded one additional year
for each 3 minor uses registered within 7 years of the first use registration. No
exclusive use period can be longer than 13 years. Data supporting a new minor use
registered after the original exclusive use period has lapsed is protected for 10 years,
as long as the data are not used to support a registration for a non-minor use and the
minor use registration remains in effect.

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The FQPA requires EPA to report within 3 years of enactment on its progress
in registering minor uses.
A second category of minor-use pesticides are the “antimicrobial pesticides”
used, for example, as preservatives in paint, antifoulants in industrial cooling water,
disinfectants, and sanitizers. The FQPA, Title II, Subtitle B sets time limits for
registration of such pesticides and directs EPA to identify and evaluate reforms to the
registration process to reduce review periods to the maximum extent practicable.
Maximum time periods for review are specified in Subtitle B for various activities.
EPA believes that these provisions might divert scarce EPA resources from more
important tasks.
Some pesticides used to protect public health from diseases carried by insects
or other animals are considered minor-use pesticides. The FQPA, Title II, Subtitle
C extends some of the provisions for agricultural minor uses to “public health
pesticides,” but also increases the involvement of the DHHS Secretary in decisions
about pesticide registration.3 It also directs EPA to identify pests of significant public
health importance and to analyze and compare public health benefits of pesticide use
against the risks. This subtitle authorizes appropriations up to $12 million for
FY1997 and “such sums as may be necessary” thereafter to implement FIFRA
Section 4.4 EPA supported these provisions.
Title II, Subtitle D of the FQPA establishes an expedited review process for
applications to register or amend registrations for pesticides that are expected to
reduce overall pesticide risks. EPA also supported this subtitle.
Promoting Integrated Pest Management (IPM). Title III defines “integrated
pest management” and directs USDA and EPA to cooperate in establishing a
research, demonstration, and education program to support adoption of IPM
techniques. In addition, federal agencies would be directed to use and promote IPM.
This provision was not controversial.
Coordinating FIFRA and FFDCA Regulations for Food-Use
Pesticides
EPA has a long-standing policy of coordinating implementation of all statutory
provisions governing pesticides for food uses, which the agency recently reaffirmed
(61 Federal Register 2378, Jan. 25, 1996). Based on this coordination policy, EPA
revoked FFDCA Section 408 tolerances for raw agricultural commodities if it
revoked the corresponding FFDCA Section 409 food additive tolerances for residues
in processed foods. Public Law 104-170 eliminates the distinction between raw and
processed food tolerances and the need to coordinate two sets of tolerances, because
FFDCA now regulates all pesticide residues under an amended FFDCA Section 408.
3The DHHS Secretary delegates duties under FFDCA to FDA.
4Based on the heading for subsection (m), “Authorization of Funds To Develop Public
Health Data,” this $12 million is intended to develop data to support registration of public
health pesticides, but the sentence authorizing appropriations states that it is “to carry out
the purposes of this section” [emphasis added].

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To ensure that pesticide registrations are based on current scientific and legal
standards, FIFRA requires EPA to reregister all pesticides registered for use prior to
1984. Prior to enactment of P.L. 104-170, FFDCA did not have a similar
requirement for revisiting pesticide residue tolerances. EPA partly addressed
concerns about tolerances for older pesticides through its coordination policy: EPA
revoked FFDCA pesticide residue tolerances after it canceled the corresponding
FIFRA pesticide registrations for food uses if (and vice versa). However, EPA took
6 years on average, far longer than necessary, according to a December 1994 GAO
report, to revoke tolerances after food-use pesticide registrations were canceled.5
Delays in completing the reregistration process were further cause for concern about
the adequacy of older tolerances to protect human health.
Public Law 104-170 mandates FIFRA-FFDCA coordination as well as periodic
review of tolerances for pesticide residues. All tolerances and exemptions in effect
when P.L. 104-170 was enacted must be reviewed within 10 years. The law also
requires EPA to reevaluate FFDCA tolerances and exemptions when reregistering
older pesticides for uses on food and animal feed. It requires EPA to revoke or
suspend tolerances for pesticides if the relevant food-use registration is canceled or
suspended under FIFRA. Revocation of a tolerance will become effective within 180
days of the date on which the pesticide use becomes unlawful, unless residue of the
pesticide will unavoidably persist. The reverse situation also is covered: by
amending the FIFRA definition of “unreasonable adverse effects on the environment”
to include human dietary risk from pesticide residue that violates a tolerance, it will
prevent EPA from registering a pesticide (or will require cancellation of an existing
registration) for a food use if a tolerance cannot be established (or is revoked) for that
pesticide on that food. The FQPA also requires EPA to establish tolerances for
residues that are expected to result from pesticide applications to foods allowed
because EPA has granted an emergency exemption from FIFRA registration
requirements under FIFRA Section 18.
Food Safety Provisions and Amendments to the Federal Food, Drug,
and Cosmetic Act
Reducing Reregistration Delays. Since 1972, FIFRA has required EPA to
reregister older pesticides based on data that meet current registration and scientific
standards. Long concerned with EPA’s progress in reregistration, Congress
strengthened and accelerated FIFRA requirements in 1988 and directed the Agency
to reregister by 1997 all pesticides originally registered before 1984, when less
toxicity information was available. By September 30, 1995, EPA had completed
reregistration actions for 170 or about 30% of the active pesticide ingredients for
which manufacturers support reregistration. Early in 1996, EPA expected to
complete reregistration by the end of FY2004, 7 years after the 1988-mandated
deadline of FY1997.
During the debate over H.R. 1627, EPA argued that timely completion of
reregistration required that Congress increase and extend EPA’s funding authority;
5U.S. GAO. Pesticides: Reducing Exposure to Residues of Canceled Pesticides,
GAO/RCED-95-23. Gaithersburg, MD.

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this authority would have expired September 30, 1997.6 Reregistration is financed
through a combination of appropriated funds and registration “maintenance” fees
paid by pesticide manufacturers. Fee collections have been lower and costs higher
than originally anticipated, according to EPA. EPA and pesticide registrants agreed
upon a schedule of increased revenues that Congress authorized in a package of
technical amendments to the 1990 farm bill (P.L. 102-237). It increased the annual
registration maintenance fee cap while allowing continued agency discretion to adjust
product fees to generate $14 million annually to carry out reregistration. In spite of
this change, last year EPA estimated a budget deficit of $105 million to complete
reregistration. In 1996, the Assistant Administrator for Prevention, Pesticides, and
Toxic Substances predicted that FY1996 registration and reregistration would be at
least 20% less than in FY1995 due to budget constraints and the government
shutdown.
The FQPA, Title V, extends EPA authorization to collect $14 million annually
in registration maintenance fees from pesticide registrants until the end of FY2001.
It authorizes collection of up to $2 million in additional fees in FY1998, FY1999,
and FY2000. EPA is required to complete processing of all pending applications for
expedited review within 5 years of enactment.
Although pesticide manufacturers supported this extension of the maintenance
fees, they argued that historical funding levels had been adequate, and they
questioned whether EPA had managed funds efficiently. The industry wanted the
Agency to develop a system of accountability for expenditures on reregistration. A
recent General Accounting Office (GAO) report responding to a request by the House
Committee on Agriculture appeared to support industry’s position.7 GAO
recommended that Congress require a fiscal 1996 full scope audit of the FIFRA fund
to consider “the reasonableness of the overhead allocation and the adequacy of
disclosures of direct and indirect costs.”8 In addition, EPA should prepare a schedule
for the reregistration process indicating how many reregistration decisions will be
completed each year and specifying the chemical cases to which decisions will apply,
according to the report. GAO indicated that such measures would allow Congress
to oversee EPA efforts to ensure that the high-risk pesticides are addressed first.
(FIFRA requires EPA to give priority in reregistration to certain pesticides, including
pesticide active ingredients used on food that may result in post-harvest residues (7
USC 136a-1(c)(1)(A)). GAO suggested amending H.R. 1627 to incorporate these
recommendations.
As GAO suggested, Congress enacted FQPA provisions directing EPA to
establish and publish annually performance measures and goals, including goals for
reregistration, and to ensure that expenditures from fees are used only to accomplish
6The President’s “Balanced Budget Act of 1995 for Economic Growth and Fairness”
proposes extending until 1999 existing EPA authority to impose maintenance fees; this
authority expires in FY1997. The President also would authorize collection of additional
fees to support reregistration.
7U.S. GAO. FIFRA Reporting Requirements. GAO/AIMD/RCED-96-21R. Gaithersburg,
MD.
8Ibid.

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those goals. The FQPA also requires an annual audit of the fees collected and
disbursed, and EPA attainment of performance goals.
One reason for higher than expected costs and reregistration delays has been late
and deficient reregistration package submissions, according to EPA, and these
problems are being addressed. EPA requires manufacturers applying to register or
reregister a pesticide to submit reports of scientific studies on pesticide toxicity and
behavior in the environment. The Agency requires that studies conducted by industry
conform to EPA standards of scientific quality. Studies that do not meet EPA
standards are rejected and must be repeated and then reevaluated. Rejected studies
contribute to the high cost of registration. While pesticide registrants have argued
that EPA’s scientific standards for maintaining pesticide registrations are excessive,
EPA has insisted that registration decisions should be based on the best available
science. In the past, EPA rejected approximately 30% of studies submitted. A 1991
analysis of factors contributing to late and deficient study submissions prompted a
joint EPA-industry project to improve performance. Due to workshops, additional
EPA guidance, and independent efforts of individual companies, the study rejection
rate today is half of what it was 3 years ago and many submissions are more timely,
according to EPA.
Some argued that industries have little incentive to submit timely and adequate
applications to maintain registrations of older pesticides; while a decision is pending
about the safety of the older pesticides, manufacturers may continue to market them.
The sooner the application is complete, the sooner EPA will be able to make a
reregistration eligibility decision (RED), and there is no guarantee that EPA will
declare the pesticide eligible to be reregistered for all uses, given current safety
standards. Delayed REDs (and delayed potential registration cancellations), in turn,
reduce demand for alternative pesticide products. This is true in part because new
product alternatives, although they may be less hazardous and equivalently effective
for similar uses, tend to be more expensive than older products that have not been
subjected to the full battery of safety studies, giving them a competitive advantage
over newer pesticides.
Provisions of the FQPA meant to reduce potential disincentives to registration
and reregistration of certain minor-use pesticides were discussed above. In addition,
the FQPA directs the Administrator to require the submission of data when necessary
for registration review which the FQPA requires periodically, with a goal of every
15 years. To ensure data submission in a timely manner, the FQPA requires EPA to
suspend a registration if the registrant fails to take appropriate steps to secure the data
required within the time required by the Administrator.
Protecting Infants and Children from Pesticide Residues in the Diet. For
several years, Congress has been concerned about pesticide residues in the diets of
infants and children. A 1993 National Academy of Sciences (NAS), National
Research Council (NRC) report concluded that there are both quantitative and
sometimes qualitative differences between children and adults in toxicity of

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pesticides and in exposure to pesticide residues in foods.9 It recommended that
“better data on dietary exposure to pesticide residues should be combined with
improved information on the potentially harmful effects of pesticides on infants and
children.”10 Information on the potentially harmful effects of pesticides would be
improved, it stated, by toxicological testing of pesticides to determine perinatal and
childhood toxicity and developing better methods to estimate exposure and the
magnitude of potential adverse health effects. The committee also advised EPA to
revise its process for setting pesticide residue tolerances under the FFDCA so as to
safeguard the health of infants and children.
The FQPA, Title III requires that the USDA Secretary, in consultation with EPA
and DHHS —
! develop and implement procedures to collect data on food consumption
patterns of infants and children;
! improve residue data collection by providing guidelines for analysis and
reporting and increasing sampling of foods most likely consumed by infants
and children; and
! collect data of statewide or regional significance on pesticide use on major
crops and crops of dietary significance.
In addition, EPA is required to ensure that pesticide tolerances adequately safeguard
the health of infants and children (Section 405, amending FFDCA Section
408(b)(1)(E)).
Some scientists have argued that data gathering provisions alone are not
adequate to protect the health of infants and children; their sensitivities and
exposures must be taken into account in risk assessment and tolerance setting, these
scientists say. The Administration asked Congress to require EPA to consider the
diets and sensitivity of children in setting tolerances.11 Congress added such
provisions by amending tolerance setting procedures of the FFDCA Section 408.
(See the discussion below.)
In addition, Title III requires EPA to report to Congress on progress in
improving federal efforts to collect pesticide use information, including an analysis
of the quality and reliability of information collected by USDA, EPA, and other
federal agencies and of options to improve performance with respect to costs,
burdens on pesticide users, and tracking of risk reduction.
9Pesticides in the Diets of Infants and Children, Washington, DC, National Academy Press.
(1993) 386 p.
10Ibid. P. 12.
11U.S. Congress. House. Committee on Agriculture. Subcommittee on Department
Operations, Nutrition, and Foreign Agriculture. Food Quality Protection Act of 1995.
Hearing, 104th Cong., 1st Sess., May 16, 1995. Washington, U.S. Govt. Print. Off., 1995. P.
15.

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Revising Tolerance-Setting Criteria for Pesticide Residues in Food.
The Delaney Clause. A key issue in the 104th Congress was whether to revise
the so-called “zero-risk” standard of the Delaney Clause (FFDCA, Section 409)
which prohibits the addition of potentially cancer-causing substances to foods. The
application of the Delaney Clause to pesticide residues has been criticized for being
unscientific and creating a confusing and inconsistent set of standards for safety,
depending on whether a pesticide was on a raw or processed food and whether it was
a carcinogen or not.
Critics of pesticide regulation under the Delaney Clause maintained that it was
unscientific, because very small pesticide residues pose no significant risk to health.
Technology is now sophisticated enough to detect extremely small amounts of
pesticides in food, in some cases levels of parts per trillion. Thus, food industry
representatives claimed that rigid enforcement of the Delaney Clause (i.e., banning
any measurable pesticide concentration) stifled research and development of new
pesticides which might have been safer than products on the market. Critics noted
that many foods contain natural carcinogens (which are not regulated under Delaney)
that may be more concentrated and more potent than pesticide chemical residues;
they said that residues might even have resulted from pesticide use to control fungi
or bacteria that produce natural carcinogens. In addition, they claimed that in some
cases, the distinction between raw and processed foods made no sense: the absolute
amount of pesticide in a food before and after processing might be the same, yet a
tolerance could be set for the residue in raw food and prohibited for the residue in
processed food, because the residue had concentrated relative to the total food weight
(due to drying or other processing).
Delaney Clause supporters argued that the public does not want to be exposed
to carcinogenic pesticides in their food, no matter how small the risk. With regard
to naturally occurring carcinogens in food, they argued that federal agencies could
not readily assess and reduce that risk, especially since natural anti-carcinogens often
are found in the same food as the carcinogens. To reduce the overall cancer risk,
therefore, they believe the federal government should minimize pesticide chemical
residues in food.
The Delaney Clause also was problematic, according to some, because it
required regulators to treat potentially carcinogenic pesticides more stringently than
pesticides that may exert other health effects. This situation set up a paradox: by
stringently regulating carcinogens, Section 409 may have reduced the safety of some
foods. Section 409 allowed approval of pesticide residues that posed greater risks
than residues of carcinogens which Section 409 did not permit, because many
registered pesticide products have health effects other than cancer. For this reason,
the National Research Council (NRC) of the National Academy of Sciences
recommended in 1987 that all pesticide residues in food, whether raw or processed,
should be regulated on the basis of a consistent “negligible risk” standard.12
12National Research Council, National Academy of Sciences. Regulating Pesticides in
Foods: The Delaney Paradox, Washington, National Academy Press, 1987. 272 p.

CRS-11
A New Standard of Food Safety. H.R. 1627, as introduced, proposed a single
“negligible risk” standard for pesticide residue tolerances. This provision was
strongly supported by food processors, growers, the agricultural chemical industry,
and the National Association of State Departments of Agriculture (NASDA). Others
preferred keeping the “zero-risk” standard and phasing out the use on food of
pesticides classified as “probable human carcinogens.”13
The Administration favored a single statutory standard for pesticide residues in
raw and processed food. However, it argued that for pesticide residues with health
effects other than cancer, such as birth defects or neurotoxicity, it was unclear how
a negligible risk standard would apply.14 EPA wanted to set tolerances based on the
health-based standard for non-carcinogens in the FFDCA, Section 409 — “a
reasonable certainty of no harm.”15 The Administration’s view is reflected in the
FQPA.
The FQPA, Title IV amended the FFDCA, but did not amend or repeal Section
409 which contains the Delaney Clause; Section 409 remains in effect for food
additives that are not pesticide residues. Rather, the FQPA redefined terms such as
“pesticide chemical” and “food additive” so that residues of pesticides in processed
as well as raw foods will be regulated under an amended Section 408, rather than
under Section 409. Section 408 tolerances also will apply to residues of breakdown
products of pesticides — i.e., substances resulting from metabolism or degradation
of pesticides — and to residues of inert ingredients and their breakdown products in
raw and processed food.
As amended by the FQPA, Section 408 authorizes EPA to set a tolerance for a
pesticide residue in or on food (whether raw or processed) only if the Administrator
decides that the tolerance is “safe.” A “safe” tolerance is defined as a level at which
13Depending on the overall weight of scientific evidence for carcinogenicity, EPA has
classified some chemicals, including pesticides, as:
Group A - Known human carcinogens
Group B - Probable human carcinogens
Group C - Possible human carcinogens
Group D - Inadequate evidence to classify, or
Group E - Not likely to be carcinogenic to humans
This classification scheme may soon change: EPA has proposed new guidelines for cancer
risk assessment. The new scheme would describe the cancer-causing potential of a chemical
in a narrative up to two pages long. Carcinogenic potential would be categorized as
“likely,” “known,” “not likely,” and “cannot be determined.”
14U.S. Congress. House. Committee on Agriculture. Subcommittee on Department
Operations, Nutrition, and Foreign Agriculture. Food Quality Protection Act of 1995.
Hearing, 104th Cong., 1st Sess., May 16, 1995. Washington, U.S. Govt. Print. Off., 1995. P.
15.
15The phrase “a reasonable certainty of no harm” is taken from the legislative history of
FFDCA, Section 409: “Safety requires proof of a reasonable certainty that no harm will
result from a proposed use of an additive. It does not — and cannot — require proof beyond
any possible doubt that no harm will result under any conceivable circumstance” (H. Rept.
2284, 85th Cong., 2d Sess. (1958)).

CRS-12
there is “a reasonable certainty of no harm” from the exposure. This is the same
standard that formerly was applied to non-carcinogenic pesticide residues in
processed foods under Section 409. However, the new law 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) and to other pesticides that have
the same toxic effects on people. No quantitative standard of safety is established by
the new law, but the Committee on Commerce expects EPA to continue setting
standards to ensure safety as it has 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 when
data are extrapolated from animal studies.16
In determining a safe level, EPA is directed to take into account many factors,
including available information on dietary exposure to pesticides among infants and
children.
Costs and Benefits. Prior to P.L. 104-170, EPA set tolerances for pesticide
residues in processed foods under Section 409 to ensure that they were safe, without
considering benefits of pesticide use. In contrast, EPA balanced risks and benefits
in setting tolerances under Section 408. H.R. 1627, as introduced, would have
regulated pesticide residues under the old Section 408 standard. It also would have
allowed EPA to set tolerances for residues posing more than a negligible risk if the
risk were “not unreasonable” relative to the benefits of pesticide use. The
Administration objected to this proposal. In its view, agencies should weigh only
health risks and benefits that accrue to consumers, without consideration of the
“broader benefits considerations, such as regional benefits, regional economic
benefits, or economic benefits that are not direct benefits to consumers.”17 In
contrast, NASDA wanted benefits to the agricultural economy weighed against the
risks of pesticide use.
As enacted, FQPA strictly limits the nature and influence of benefits considered
in tolerance setting under Section 408. It 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
16U.S. House. Committee on Commerce. Food Quality Protection Act of 1996, H.Rept. 104-
669, Part 2, 104th Congress, 2nd Sess. 1996. P. 6.
17Ibid.

CRS-13
effect). The 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 may not be
more than 10 times the risk at a “safe” level of exposure on an annual basis 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 this
interpretation.18
The FQPA also requires EPA to distribute to major food stores nationwide
easily understood information for public display about the risks and benefits of such
pesticide residues on food and how consumers may avoid the risks without
sacrificing nutrition.
The National Coalition Against the Misuse of Pesticides reportedly has
criticized the new law for “legalizing levels of pesticides that cause cancer and other
adverse effects.”19 However, very small risks from low concentrations of pesticide
residues such as those permitted under the FQPA also were permitted prior to
passage of the new law. In addition, low concentrations of potential carcinogens
were legal on raw food before passage of the FQPA, as long as the risks were
reasonable considering the benefits of the pesticide. The new Section 408 tightens
the standard for pesticide residues in food. In the future, raw food tolerances, as well
as tolerances for processed foods, must be “safe” and ensure with “a reasonable
certainty” that no harm will result from exposure to that residue, other residues on
other foods, other sources, and other pesticides that have the same toxic effects on
people. Only pesticides with health effects that have no known threshold (e.g., some
cancers) are excepted from the “safe” standard, only under specified conditions, and
only if the increased risk is within strict limits. Moreover, the new law allows
growers to avoid use of pesticides that pose relatively large risks of health effects
other than cancer by allowing pesticide residues in processed foods that pose smaller
cancer risks.
Other Provisions Affecting Tolerances. The FQPA directs EPA to develop a
screening program to evaluate whether pesticides may have effects in humans that
are similar to effects produced by naturally occurring estrogen or other endocrine
18Ibid.
19Broderick, Brian, “House repeals Delaney Clause in compromise FIFRA, FFDCA bill,
Daily Environmental News, July 24, 1996. Bureau of National Affairs, Washington, p. A-1.

CRS-14
effects. If EPA finds such effects, it is required to use its existing statutory authority
to ensure the protection of public health.
Finally, the FQPA directs EPA to review within 10 years of enactment all
pesticide residue tolerances and exemptions in effect before enactment. It authorizes
anyone to petition EPA to establish, modify, or revoke a tolerance or an exemption,
and provides 60 days for public comments on pending proposals. In addition, a
person adversely affected by a final regulation has twice the time provided under
previous law — 60 days rather than 30 — to file an objection.
Preempting State Pesticide Residue Tolerances. Although federal pesticide
residue tolerances are typically accepted across the nation, the FFDCA, before it was
amended by P.L. 104-170, authorized states to impose tighter restrictions. For
example, California requires businesses to warn the public about pesticide residues
on food that pose a “significant risk” (defined as more risky than one chance in
100,000) of causing cancer or birth defects. The agricultural sector, particularly the
food industry, wanted federal standards to preempt state standards. The National
Food Processors Association argued that differing state tolerances disrupt interstate
commerce. In addition, it said farmers in states with tighter standards might be at a
competitive disadvantage to those in states with weaker regulations or enforcement.
Supporters of the balance of authority reflected by the FFDCA before amendment
argued that unique regional demographic or food consumption characteristics made
it prudent to allow states flexibility concerning food safety. Such flexibility is built
into most environmental federal laws. EPA opposed preemption, while NASDA
supported preemption of tolerance setting and warning requirements.
The FQPA establishes federal preemptive authority over tolerance setting and
exemptions when federal standards ensure that residues are “safe”, but allows for
state action under compelling local conditions with EPA approval. State and local
laws requiring a warning when a pesticide residue is present in food are permitted.20
Enforcement of Tolerances: Imports. The United States imports
approximately 15% of total domestic consumption of agricultural products, according
to EPA, and pesticides are used in producing and storing many of these imports. The
FFDCA prohibits importation of food with a pesticide residue that exceeds its
tolerance. According to GAO, in 1994 FDA tested about 1% of all imported
shipments for pesticide residue levels.21
Critics such as NASDA, contended that this monitoring rate was too low,
making it unlikely that illegal pesticide residues would be detected on imported
foods. FDA argued in the past that the low sampling rate understated the
effectiveness of its detection program, because the agency concentrated its efforts on
the foods and countries likely to be the source of residues and also on shippers with
20The introduced version of H.R. 1627 would have preempted such warnings, but this
provision was dropped from the reported bill.
21U.S. GAO. Food Safety: Changes Needed to Minimize Unsafe Chemicals in Food,
GAO/RCED-94-192. Gaithersburg, MD. P. 50.

CRS-15
a history of violations. Such a strategy was intended to identify violations more
successfully than a more frequent but random sampling. However, FDA officials
said that inadequate resources were the primary reason that the agency had not tested
a larger percentage of imported foods, according to GAO.22
Some questioned the cost and effectiveness of greatly increased FDA
monitoring, arguing that it would be better to prevent problems from happening than
to try to remedy them after the fact. They preferred developing bilateral agreements
with trading partners to achieve equivalent, but not necessarily identical, inspection
systems that could prevent contaminated products from arriving at U.S. ports of
entry. The Clinton Administration favored increasing support for FDA monitoring
of imported foods. The Administration also wanted enhanced authority to penalize
those who introduced into interstate commerce foods with residues above FFDCA
tolerances.
The FQPA authorizes an additional $12 million spread over FY1997, FY1998,
and FY1999 for increased FDA monitoring of pesticide residues on imported and
domestic foods. It also authorizes civil money penalties in lieu of penalties assessed
under FFDCA criminal authorities, seizure authorities, or injunction authorities for
persons who introduce adulterated food into interstate commerce, but not for
growers. Such penalties may not exceed $50,000 for individuals and $250,000 for
other persons, and may not exceed $500,000 for all such violations adjudicated in a
single proceeding. See CRS Report 93-821 The Safety of Imported Food for more
information about this issue.
Harmonizing U.S. Tolerances with International Standards. The United
States and its trading partners are concerned about facilitating trade as well as
ensuring the safety of food imports. Because diverse health and safety standards can
be barriers to international trade, the 104th Congress considered whether to require
EPA to “harmonize” tolerances with international pesticide residue limits. Because
diverse standards may be justified based on regional or local health and safety
concerns, the goal of harmonization is agreement on appropriate scientific and other
non-economic bases for setting standards, not a single international set of standards.
Proponents of harmonization argue that equivalent standards among countries would
promote international economic development by facilitating trade. Critics on the
other hand are fearful of weakening U.S. standards and compromising “sovereign
rights.” They favor harmonization only if countries with less stringent food safety
standards are obliged to meet more stringent U.S. standards, a process referred to as
“upward harmonization.” It is not clear whether they also would favor U.S. adoption
of more stringent standards established by other countries.
U.S. agencies have participated for years in the activities of an organization
sponsored by the United Nations, the Codex Alimentarius (that is, “food code”)
Commission, which negotiates international criteria for chemical testing,
certification, and laboratory accreditation. The FQPA amends FFDCA Section 408
to encourage EPA to set tolerances at the “Maximum Residue Levels” (MRLs)
established by the Codex, if such standards exist. If EPA chooses not to adopt the
22Ibid.

CRS-16
Codex MRL, the FQPA requires the agency to publish a notice in the Federal
Register explaining why.
Issues Considered and Dropped Prior to Passage
Preempting State, Tribal, and Local Pesticide Use Laws
Those who register and distribute pesticides sometimes complain that given
federal standards, local and state pesticide use restrictions are unnecessary and
burdensome to commerce. FIFRA specifically authorizes state regulation of the sale
and use of federally registered pesticides, as long as state regulations are at least as
restrictive as federal standards. Under FIFRA, for example, states may prohibit the
distribution and sale of a federally registered pesticide or restrict pesticide use locally
to protect groundwater, wildlife, or human health. (The FQPA does not allow
labeling or packaging requirements on pesticides in addition to, or different from,
FIFRA requirements.) Where states have not enacted preemptive legislation, local
jurisdictions also have the authority under FIFRA to regulate pesticide sales and use,
according to the U.S. Supreme Court (Wisconsin Public Intervenor v. Mortier, 111
S.Ct.2321). Environmentalists and some states’ rights advocates are determined to
preserve this interpretation of FIFRA. The Coalition for Sensible Pesticide Policy,
an umbrella group for many representing manufacturers and users of pesticides,
proposed to amend FIFRA to establish federal preemption of state regulations and
state preemption of local ordinances to facilitate national distribution of pesticide
products.23
H.R. 1627, Section 106, as reported by the House Committee on Agriculture,
would have prohibited local, but not state regulation of pesticide products. NASDA
strongly supported preemption of local pesticide use restrictions, but many states did
not. This preemption provision was dropped after the bill was reported in the House
but before the bill was debated on the House floor. (FFDCA federal preemption
authority is discussed below.)
Clarifying and Limiting Tribal Pesticide Enforcement
H.R. 1627, Title VI would have authorized Indian tribes to regulate the sale or
use of any federally registered pesticide or device and to enforce against violations
of pesticide use laws within the boundaries of a federal Indian reservation for such
tribe, but would have prohibited these tribal activities if less than 50% of such lands
were owned by members of the tribe or the tribe. The FQPA, as enacted, does not
include this title.
In general, with regard to pesticide laws, EPA treats tribes in the same way it
treats states. EPA has approximately 23 cooperative enforcement agreements with
23According to its literature, the Coalition for Sensible Pesticide Policy consists of state,
regional and national trade associations for users and manufacturers of pesticides. Members
include associations for nursery, arbor, floral, lawn and garden, agricultural, and structural
pest control companies, as well as the American Farm Bureau Federation, the National
Association of State Departments of Agriculture, and the U.S. Chamber of Commerce.

CRS-17
tribes. These delegate to designated tribal officers certain authority to conduct
activities related to enforcement, such as inspections of pesticide establishments,
within reservation boundaries (including land owned by non-members). In addition,
tribes may refer violations to EPA for enforcement under FIFRA. However, EPA
does not delegate to tribes federal enforcement authority to invoke the penalty
provisions in FIFRA. The Agency has encouraged tribes to adopt and implement
pesticide laws and regulations that are similar to FIFRA. Where they have done so,
tribes enforce tribal codes.
Some who supported Title VI argued during debate on the House floor that
states rather than tribes should enforce pesticide laws within reservation boundaries
on land owned by people who are not tribal members, if most land within reservation
boundaries is owned by nonmembers of the tribe.24 However, tribes opposed this
provision, as did the Clinton Administration. The Administration expressed strong
support for tribal authority to regulate pesticide use on all lands within tribal
jurisdiction, arguing that the federal government lacks resources to implement
pesticide programs at the local level, and that significant gaps in environmental
protection on reservations might be created if tribal authority were limited. EPA
claimed that the historical record of tribal regulation of pesticide use on reservation
lands “is one of sensible environmental protection, respect, cooperation, and a few,
well-justified enforcement actions” (Goldman, Lynn R., Letter to the Honorable Pat
Roberts, Aug. 1, 1995). Four tribal enforcement actions are recorded by EPA
Headquarters, three in South Dakota and one in Idaho.
Conclusion
The FQPA has widespread support in the community of growers, food
processors, chemical suppliers, environmental and consumer advocacy groups, and
state government agriculture officials. The Clinton Administration also generally
supports its provisions. The FQPA aims to facilitate FIFRA registration and
reregistration of pesticides for minor uses, including public health pesticides,
antimicrobial pesticides, and reduced risk pesticides; to improve data collection
relevant to pesticide residue risks to children; and to protect consumer health by
requiring FFDCA tolerances for pesticide residues on food that are “safe” and
provide “a reasonable certainty of no harm” from aggregate exposure. The new law
tightly links EPA actions under FFDCA and FIFRA and requires both tolerances and
registrations to be reviewed periodically.
The FQPA does not repeal the “zero-risk” Delaney Clause in FFDCA Section
409, but it does ensure that pesticide residues in processed foods are not governed by
that provision. Instead, the FQPA subjects all pesticide residues in food to FFDCA
Section 408 and tightens the safety standard. In the future, raw food tolerances, as
well as tolerances for processed foods, must be “safe” and ensure with “a reasonable
certainty” that no harm will result from exposure to that residue, other residues on
other foods, other sources, and other pesticides that have the same toxic effects on
people. Only pesticides with health effects that have no known threshold (e.g., some
24The Honorable Doug Bereuter, Congressional Record, July 24, 1996, p. H8146.

CRS-18
cancers) are excepted from the “safe” standard, only under specified conditions, and
only if the increased risk is within strict limits.
Congressional Hearings
U.S. Congress. House. Committee on Agriculture. Subcommittee on Department
Operations, Nutrition, and Foreign Agriculture. Food Quality Protection Act of
1995. Hearing, 104th Congress, 1st session, May 16, 1995. Washington, DC,
Govt. Print. Off., 1995. 248 p.
U.S. Congress. Senate. Committee on Agriculture, Nutrition, and Forestry,
Subcommittee on Agricultural Research, Conservation, Forestry, and General
Legislation. The Federal Insecticide, Fungicide, and Rodenticide Act (S. 958,
S. 1478, and S. 2050). Hearing, 103rd Congress, 2nd session, July 28, 1994.
Washington, DC, Govt. Print. Off., 1995. 145 p.
U.S. Congress. Senate. Committee on Agriculture, Nutrition, and Forestry.
Testimony from Administration Witnesses on Pesticide Legislation (S. 985, S.
1478, and S. 2050). Hearing, 103rd Congress, 2nd session, June 29, 1994.
Washington, DC, Govt. Print. Off., 1995, 79 p.

A-1
Appendix A. Authorities and General Provisions of
Pesticide Laws, as Amended by the FQPA
FIFRA Authority and General Provisions
FIFRA, as amended (7 USC 136-136y),25 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 the estimated 21,000 pesticide products
currently in use.26 The Act directs EPA to restrict the use of pesticides as necessary
to prevent unreasonable adverse effects on people and the environment, taking into
account the economic, social, and environmental costs and benefits of various
pesticide uses. To this end, EPA registers each pesticide for each approved use, for
example, to control boll weevils on cotton. FIFRA prohibits sale of any pesticide in
the United States unless it is registered. In addition, FIFRA requires EPA to
reregister older pesticides based on new data that meet current regulatory and
scientific standards. Most pesticides currently registered in the United States are
older pesticides and were not subject to the modern safety reviews.
When pesticide manufacturers apply to register or reregister a pesticide active
ingredient or a particular use of a registered pesticide, EPA requires them to submit
scientific data on pesticide toxicity and behavior in the environment. EPA may
require any combination of more than 100 different tests. To register a pesticide use
on food, EPA also requires applicants to identify analytical methods that can be used
to test food for residues and to provide data on the amount of pesticide residue that
could remain on crops as well as on (or in) food products, assuming that the pesticide
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 presents an unreasonable risk to human health or the
environment, and if proposed for use on a food crop, whether a safe level of pesticide
residue can be established. Establishing a safe level of residue is necessary before
granting a pesticide registration for a food-use. If a registration is granted, the
Agency specifies the approved uses and conditions of use, which the registrant must
explain on the product label. FIFRA requires that federal regulations for pesticide
labels preempt 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 restricted use.
Restricted-use products are considered more dangerous (to the applicator or the
environment) and can be used only by trained pesticide applicators certified by states.
Individual states and Indian tribes generally are responsible for training pesticide
applicators for certification.
EPA also evaluates the safety of pesticides after they are registered (or
reregistered). Registrants are required to report promptly any new evidence of
adverse effects of pesticide exposure. If evidence indicates that a registered pesticide
25FIFRA also is known as the Act of June 25, 1947.
26Exceptions are noted in 40 CFR 152.20, 152.25, and 152.30.

A-2
may pose an unreasonable risk, EPA may initiate a special review of available
information and may reevaluate the risks and benefits of each registered use.
Registrants also may be required to conduct new studies to fill gaps in scientific
understanding to permit risk assessments. If a special review or reregistration
evaluation finds that a registered use may cause “unreasonable adverse effects,” the
registration may be amended or canceled.27 Registrants also may voluntarily request
cancellation or amendment of a registration to terminate selected pesticide uses. A
request for 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 is maintained.
If a registration is canceled for one or more uses of a pesticide, it may no longer
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. An EPA decision to
cancel a registration may be appealed by the registrant. An appeal initiates a lengthy
decision 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 registration, EPA is authorized to suspend registration. Suspension orders,
which also may be appealed, stop sales and use of the pesticide.
Generally, FIFRA requirements are enforced by EPA. However, FIFRA Section
26 gives states primary authority, including inspection authority, for enforcing FIFRA
provisions related to pesticide use.
Prior to enactment of P.L 104-170, the last significant changes to the general
provisions of FIFRA were enacted in 1988 (P.L. 100-352). Authorization for
appropriations expired on September 30, 1991, although appropriations have
continued. The history and provisions of FIFRA are summarized in CRS Report 97-
49 ENR, Summaries of Environmental Laws Administered by the Environmental
Protection Agency, pages 95-101.
FFDCA Authority and General Provisions
FFDCA, as amended (21 USC 301-392), requires various federal agencies to
regulate foods, drugs, and cosmetics to ensure that they are safe for use. For the
approximately 300 pesticides registered for use in food production, the FFDCA
directs EPA to establish allowable pesticide residue levels (called tolerances) in food
and animal feed. Under FFDCA, foods with a residue of a pesticide 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 in the United States.
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
27Registrations 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.

A-3
food.28 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. 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 and set the tolerance level by issuing a regulation. EPA tolerances for
pesticide residues preempt state and local restrictions on food if they are based on
lower residue levels. States may petition for an exception if the residue level
threatens public health.
Prior to P.L. 104-170, the FFDCA directed EPA to establish tolerances for
pesticide residues on food according to criteria which differed for raw and processed
commodities. Residues in raw commodities were subject to Section 408 of FFDCA.
This provision required that residue tolerances be set at levels necessary to protect
public health considering: 1) “the necessity for the production of an adequate,
wholesome, and economical food supply,” and 2) the opinion of the Secretary of
Agriculture as to the usefulness of the pesticide. EPA interpreted this directive to
require a balancing of risks and benefits in the setting of tolerances. If a tolerance
was not necessary to protect public health, EPA was required to grant the pesticide
an exemption from the requirement for a tolerance. Section 408 made no reference
to cancer-causing chemicals.
In contrast, the former FFDCA treated pesticide residues in processed food as
food additives, which are governed by Section 409. This provision requires
tolerances for food additives to be based on “a fair evaluation of the data”
establishing that the proposed use of the additive is safe. Moreover, Section
409(c)(3)(A) prohibits a finding that a food additive is safe, if it has been found “to
induce cancer in man or animal,” Thus, it prohibits the addition of potentially
carcinogenic substances to foods. This FFDCA clause is known as the Delaney
Clause. Notwithstanding the provisions of Section 409, however, a pesticide residue
in processed food was not unsafe if it: resulted from pesticide use on a raw food in
accord with a prescribed tolerance (or exemption), was “removed to the extent
possible in good manufacturing practice,” and was in ready-to-eat food at a
concentration not greater than the tolerance for the raw food product (FFDCA
Section 402(a)(2)(C)).29 A pesticide residue in processed food was “safe,” therefore,
if it had not concentrated during food processing. If it did concentrate, the food could
be sold only if a food additive tolerance (i.e., a Section 409 tolerance) had been
established (indicating that the pesticide residue was “safe” at or below that level),
and the pesticide residue on the processed food was below that tolerance level, or an
exemption had been granted for the pesticide in that food. However, if the pesticide
was a potential carcinogen, no food additive tolerance could be established.
Therefore, processed foods could contain no greater concentration of a potentially
28That is, use on food crops, animal feed crops, or food products directly (e.g., grains, fruits,
or vegetables after harvest).
29Section 402 has become known as the “flow-through” provision. This means that if the
amount of the pesticide residue in the processed food is less than the tolerance for the raw
food, then EPA does not need to establish a tolerance under Section 409.

A-4
carcinogenic pesticide residue than was permitted in the same food before
processing, and no residue at all if the pesticide was not used on the raw food. A
1992 decision by the U.S. Court of Appeals for the Ninth Circuit explicitly barred
balancing of risks and costs in setting a Section 409 tolerance for a carcinogenic
pesticide, no matter how small the cancer risk (Les v. EPA, CA 9, No. 91-70234).
This decision led EPA to propose revoking several food additive tolerances for
potentially carcinogenic pesticide residues in processed foods.
Pesticide residues in processed food, even if they have concentrated during
processing, are no longer subject to Section 409 or the Delaney Clause. All pesticide
residues are regulated under the amended FFDCA Section 408. The standard for
tolerance setting under this revised standard is that aggregate exposure to the
pesticide must be “safe”. See pages 11 to 12 in the main body of this report for more
information about the revised food safety standard.
EPA has long coordinated pesticide registrations for food uses under FIFRA
with tolerance setting under FFDCA. Public Law 104-170 codifies this policy.
Thus, if EPA revokes a residue tolerance under FFDCA, it cancels the FIFRA
pesticide registration for that food use. EPA explains, “Legally-used pesticides
should not result in illegal food” (61 Federal Register 2379, Jan. 25, 1996). EPA
traces the origin of its coordination policy to the legislative history of FFDCA
Section 408 (S. Rept. 1635, 83rd Cong., 2nd Sess. 1954, p. 3). 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. (Formerly, the Agency also coordinated pesticide residue tolerances for
raw foods with food additive tolerances for the corresponding processed foods: when
it revoked a Section 409 (food additive) tolerance for a processed food, it also
revoked the corresponding tolerance for the raw agricultural commodity. This effort
will no longer be required as both raw and processed foods are subject to the same
Section 408 tolerance.)
FFDCA directs the Food and Drug Administration (FDA) in the Department of
Health and Human Services (DHHS) and U.S. Department of Agriculture (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.
Prior to P.L. 104-170, FFDCA provisions related to pesticide residues on food
were last significantly amended in 1958 by the Food Additives Amendments of 1958
(P.L. 85-929). There is no specific authorization for FFDCA appropriations.

B-1
Appendix B. Section-by-Section
Summary of P.L. 104-170
Provision
P.L. 104-170
Short Title
§1 - The Act is the “Food Quality Protection Act of 1996"
Title I — Suspension - Applicators
Reference
§101 - Title I amends FIFRA
Subtitle A - Suspension
Suspension
§102 - Amends FIFRA §6(c); authorizes an emergency
suspension order before EPA issues a notice of its intention to
cancel the registration or to change the classification of the
pesticide. Such emergency order expires after 90 days if EPA
has not issued a notice under Section 6(b).
Reregistration
§103 - Amends FIFRA §4(g)(2) to require reassessment of
of Food-Use
residue tolerances and exemptions issued under the FFDCA as
Pesticides
soon as EPA has sufficient information about the dietary risk of
an active ingredient and at the time EPA makes a reregistration
decision
Science Review
§104 - Amends FIFRA §25(b) to establish a Science Review
Board
Board of 60 scientists to assist in Scientific Advisory Panel
Established
(SAP) reviews; SAP selects Board members
Nitrogen
§105 - Distinguishes “nitrogen stabilizers” from other pesticides
Stabilizers
State and Local
§106 - Amends FIFRA to eliminate Section 6 requirement to
Authority
cancel registration after 5 years; adds new subsection (g) to
Section 3 requiring periodic registration review, with a goal of
every 15 years
Subtitle B - Training for Maintenance Applicators and Service Technicians
Definitions
§120 - Defines “maintenance applicator” and “service
technician”
Training of
§121 - Authorizes States to establish requirements for training
Maintenance
maintenance applicators and service technicians in handling and
Workers
use of pesticides; limits EPA authority

B-2
Provision
P.L. 104-170
Title II - Minor Use Crop Protection, Antimicrobial Pesticide Registration
Reform, and Public Health Pesticides
Reference
§201 - Title II amends FIFRA
Subtitle A - Minor Use Crop Protection
Definitions
§210(a) - Defines “minor use”
Time to Submit
§210(b) - Extends exclusive data use period 1 year for each 3
Data Supporting
minor uses registered; protects for 10 years data supporting a
Minor Use
new minor use of a registered pesticide with no remaining period
Registration
of data protection
Deadline for
§210(c) - Extends deadline for residue chemistry data for a minor
Residue Data
use registration until final submission date for other pesticide
uses
Authority to
§210(d) - Authorizes data waiver for minor use registration if
Waive Data
risk still could be assessed and would be reasonable
Requirements
Expedited
§210(e) - Requires EPA to act expeditiously on a complete
Registration
application for minor use registration
Unsupported
§210(f) - Requires EPA to temporarily extend registration for a
Minor Use
minor use that is not supported for reregistration until after the
Registrations
final data submission deadline for all supported uses
Cancellation of
§210(g) - Lengthens from 90 days to 180 days the EPA waiting
a Minor Use
period prior to granting a request for voluntary cancellation of a
Registration
pesticide registered for a minor use
Registration
§210(h) - Requires EPA to consider an application to register a
Transfers
minor use in light of a substantially similar pesticide use that was
registered if such registration was voluntarily canceled while the
new application was pending
EPA Minor Use
§210(i) - Establishes a minor use program in EPA; requires EPA
Coordination
report on progress in registering minor uses
USDA Minor
§210(j) - Requires USDA to coordinate its minor use activities;
Use
establishes a minor use matching grant program to develop data
Coordination
supporting minor use pesticide registrations and reregistrations;
and Grant
establishes a Minor Use Pesticide Data Revolving Fund;
Program
authorizes appropriations of $10 million annually

B-3
Provision
P.L. 104-170
Subtitle B - Antimicrobial Pesticide Registration Reform
Definition
§221 - Defines “antimicrobial pesticide”
Coordination of
§222 - Amends FIFRA to require coordination of FIFRA data
Requirements
requirements for pesticide registration
and Deadlines
Changes to
§223 - Allows specified changes to labels for antimicrobial
Labels
pesticides 60 days after the registrant notifies EPA, if EPA does
not disapprove within 30 days of receiving notice
Antimicrobial
§224 - Adds a new subsection (g) to FIFRA §3; directs EPA to
Pesticide
reduce registration requirements for antimicrobial pesticides;
Registration
establishes goals and limits for review and notification
Reform
requirements; requires annual report on reform progress
Transportation,
§225 - Removes EPA authority to specify requirements for
Storage, and
pesticide registration and labeling with respect to storage,
Disposal of
disposal, transportation, and recall of household, industrial, and
Disinfectants
institutional antimicrobial products that are not subject to the
and Sanitizers
Solid Waste Disposal Act (42 USC 6901 et seq.), unless
regulation is necessary to prevent an unreasonable adverse effect
Subtitle C - Public Health Pesticides
Definition
§230 - Amends the definition of “unreasonable adverse effects on
the environment;” requires EPA to weigh pesticide risks against
health risks posed by the pesticide target, e.g., disease-carrier
insects; defines “public health pesticide” and “vector”
Data
§231 - Requires EPA to consider the public health and
Requirements
agricultural need for a minor use pesticide and beneficial or
adverse effects on the environment when establishing data
requirements
Reregistration
§232 - Exempts public health pesticides from reregistration fees
of Public Health
if economic return does not support registration; requires EPA to
Pesticides
use existing expedited processing funds to assure expedited
review of public health pesticide applications
Changes in
§233 - Requires DHHS to provide benefits and use information
Public Health
and analysis when a public health use is affected by a proposed
Pesticide
change in a pesticide registration
Registrations
DHHS
§234 - Requires EPA to solicit DHHS views prior to publishing a
Comments
regulation for a public health pesticide
Consideration
§235 - Requires EPA to take into account the risk and relevant
of Public Health
data for public health pesticides
Pesticides

B-4
Provision
P.L. 104-170
Control of
§236 - Requires EPA to identify pests of “significant public
Significant
health importance” and to promote methods to control them
Public Health
Pests
Authorization of
§237 - Authorizes arrangements to conduct studies to develop
Appropriations
data needed to register or reregister public health pesticides;
authorizes appropriations for FIFRA Section 4 of up to $12
million for FY1997, and thereafter, such sums as may be
necessary
Subtitle D - Expedited Registration of Reduced Risk Pesticides
Reduced Risk
§250 - Amends FIFRA §3(c); directs EPA to develop procedures
Pesticides
to expedite reviews of pesticide uses that may: reduce pesticide
risks to human health, reduce pesticide risks to nontarget
organisms, reduce contamination of valued environmental
resources, or broaden adoption of integrated pest management
(IPM) strategies
Title III - Data Collection Activities to Assure the Health of Infants and
Children and Other Measures
Data Collection
§301 - Requires USDA, EPA, and DHHS to coordinate in
to Assure the
developing and implementing survey procedures to ensure
Health of
collection of adequate data on food consumption of infants and
Infants and
children (Also see §405 amendment to FFDCA §408(b)(2)(C))
Children
Pesticide Use
§302 - Requires USDA to collect data of statewide or regional
Data
importance on pesticide use on major crops and crops of dietary
significance
Integrated Pest
§303 - Requires USDA to cooperate with EPA to conduct
Management
research, demonstration, and education programs supporting
IPM; directs federal agencies to use and promote IPM
FIFRA-FFDCA
§304 - Amends FIFRA definition of “unreasonable adverse
Coordination
effects on the environment” to include dietary risk from pesticide
residues inconsistent with the EPA-established food tolerance
under FFDCA §408
Pesticide Use
§305 - Requires USDA, in consultation with EPA, to report on
Data Report
pesticide use data collection by federal agencies
Title IV - Amendments to the Federal Food, Drug, and Cosmetic Act
Short Title and
§401 - Title IV may be cited as the Food Quality Protection Act
Reference
of 1996; it amends FFDCA
Definitions
§402 - Amends and adds definitions for “pesticide chemical,”
“pesticide chemical residue,” “food additive,” “processed food,”
and “Administrator”
Confidential
§403 - Amends FFDCA §301(j) to prohibit disclosure of
Data
confidential data

B-5
Provision
P.L. 104-170
Adulterated
§404 - Amends FFDCA §402(a)(2) so that pesticide residues on
Processed Food
raw or processed food that are “unsafe” within the meaning of
§408 cause a food to be deemed adulterated
Pesticide
§405 - Amends FFDCA §408 regulating pesticide residues in
Residues in
food
Food
Safety of
New §408(a)(1) - Defines raw and processed food products as
Pesticide
“food” and a pesticide residue on food as “unsafe,” unless a
Residues
tolerance is in effect and the residue level is below the tolerance,
or an exemption from the requirement exists
Safety of
New §408(a)(2) - Defines a pesticide chemical residue on
Residues in
processed food as not unsafe if the residue results from pesticide
Processed Food
use that conforms to a tolerance for the raw commodity, the
residue has been removed to the extent possible in “good
manufacturing practice,” and the concentration of processed food
residue is not greater than the raw food tolerance, or an
exemption is in effect for the raw food
Pesticide
New §408(a)(3) - Defines a food residue of a degradation
Degradation
product of a pesticide as safe if: (A) EPA has determined that
Products
the dietary health risk posed by the breakdown product is not
likely to be different than that posed by the parent pesticide;
(B)(i) a tolerance exists for the parent pesticide and the combined
residue of the parent pesticide and breakdown product is less
than the tolerance; or (ii) a tolerance exemption exists for the
parent pesticide; and (C) the tolerance or exemption for the
parent pesticide does not state that it applies only to the parent
pesticide or that it does not apply to the breakdown product
Effect of a
New §408(a)(4) - Food with pesticide residue shall not be
Tolerance or
“adulterated” within the meaning of §402(a)(1) while a tolerance
Exemption
or exemption is in effect for that pesticide residue on that food
Authority for
New §408(b)(1) - Authorizes EPA to establish, modify, or
Tolerance
revoke tolerances for pesticide residues on food in response to a
Setting
citizen petition or on its own initiative
Standard for
New §408(b)(2)(A) - (i) Prohibits setting or retaining a tolerance
Tolerances
unless EPA determines that the level is “safe;” directs EPA to
modify or revoke any tolerance that is not “safe;” (ii) defines
“safe” to mean that there is “a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical
residue,” considering all sources of exposure for which there is
reliable information; (iii) a pesticide chemical residue for which
a “safe” tolerance exists is not an eligible pesticide chemical
residue (see below)

B-6
Provision
P.L. 104-170
Eligible
New §408(b)(2)(B) - (i) Defines “eligible pesticide chemical
Pesticide
residue” as a residue for which a harmless exposure level cannot
Chemical
be identified (that is, it exerts a nonthreshold health effect), the
Residues
lifetime risk of such effect has been estimated using quantitative
risk assessment, and aggregate exposure to the residue is safe
with respect to other effects for which EPA is able to identify a
harmless level (that is, threshold effects)
(ii) - Allows EPA to maintain a tolerance for an eligible residue
if (iii) the pesticide use protects consumers from greater health
risks than are posed by the residue, or the pesticide use is needed
to avoid a “significant disruption in domestic production of an
adequate, wholesome, and economical food supply;” and (iv)
aggregate exposure to the pesticide chemical (including dietary
exposure at the tolerance level) poses a yearly risk not more than
10 times and a lifetime risk not more than twice that of aggregate
pesticide exposure when the tolerance is at a “safe” level
(v) - Requires review of tolerances for eligible residues at least
every five years
(vi) - Requires tolerances for eligible residues to protect the
health of infants and children (see below)
Exposure of
New §408(b)(2)(C) - Directs EPA when evaluating an existing
Infants and
tolerance or exemption, (i) to assess the risk to infants and
Children to
children considering consumption patterns, special susceptibility,
Eligible
and cumulative effects, and (ii) to ensure with a reasonable
Residues
certainty that no harm will result to infants and children; EPA
may apply a tenfold margin of safety for potential pre- and post-
natal toxicity and inadequate exposure and toxicity data
Mandated
New §408(b)(2)(D) - Requires EPA to consider certain factors
Considerations
when it establishes or reconsiders a tolerance or exemption
in Tolerance
Decisions
Residue Data
New §408(b)(2)(E) - Authorizes EPA to consider data on
anticipated residue levels and actual residue levels; 5 years after
a tolerance is set, requires data submissions demonstrating
residues are below those used to set tolerances; requires
tolerance to be modified or revoked if data are not provided or
fail to demonstrate that residues are below those used to set the
tolerance
Percent of Food
New §408(b)(2)(F) - Authorizes EPA when setting tolerances to
Treated with
consider data on the percent of food actually treated with the
Pesticide
pesticide, but only if EPA finds that the data meet certain criteria
and provides for periodic reevaluation of the estimate derived
from the data
Tolerances Near
New §408(b)(3) - (A) Prohibits tolerance setting unless a
the Level of
practical method is identified for detecting and measuring
Detection
pesticide levels; (B) Prohibits setting a tolerance below the limit
of detection of the specified method

B-7
Provision
P.L. 104-170
International
New §408(b)(4) - Directs EPA to explain its reasons if it
Residue Levels
proposes a tolerance inconsistent with the international Codex
Maximum Residue Level
Authority for
New §408(c) - Authorizes EPA to establish, modify, or revoke a
Issuing
tolerance exemption in response to a petition or on its own
Exemptions
initiative; permits EPA to allow an exemption only if it is “safe,”
meaning that there is a “reasonable certainty that no harm will
result from aggregate exposure” to the pesticide residue from all
sources for which information is reliable; requires consideration
of certain factors; prohibits exemptions if there is no practical
method for detecting and measuring the levels of residue, unless
there is no need for such a method and a reason is provided
Petitions
New §408(d) - Authorizes any person to file a petition for
issuance, modification, or revocation of a tolerance or
exemption; requires specified petition contents and authorizes
EPA regulations requiring information and data to support a
petition; directs EPA to publish a notice of each complete
petition and to respond by issuing a regulation revising the
tolerance or exemption or an order denying the petition;
establishes priorities and an expedited procedure for reviews of
petitions relating to residue tolerances that appear safer than
existing residue tolerances for other pesticides with similar uses;
requires EPA action within 180 days respecting a tolerance for an
“eligible pesticide residue” if a tolerance or exemption is
established for a safer pesticide residue for a similar use
Administrative
New §408(e) - Authorizes EPA to issue regulations to set,
Procedures
suspend, or revoke tolerance or an exemption or to establish
general implementation procedures; requires 60-day comment
period
Data to Support
New §408(f) - Requires EPA to collect additional data when they
Existing
are reasonably required to support an existing tolerance or
Tolerances and
exemption; directs EPA to issue a notice under FIFRA
Exemptions
§3(c)(2)(B), a rule under the Toxic Substances Control Act 4, or
an order to request testing and data submissions; authorizes
modification or revocation of a tolerance or exemption if data are
not submitted on time
Objections and
New §408(g) - Provides any person 60 days to file an objection
Hearings
to a rule or order and to request a hearing; authorizes EPA to
decide whether a hearing is necessary
Judicial Review
New §408(h) - Authorizes persons adversely affected to petition
for judicial review of a regulation establishing general
implementation procedures under new §408(e) or an order
requesting data submissions under new §408(f) or stating EPA’s
response to objections filed under new §408(g); 60 days are
provided for filing petitions after the regulation or order is
published

B-8
Provision
P.L. 104-170
Confidential
New §408(i) - Requires confidential treatment of data supporting
Business
a tolerance
Information
Technical
New §408(j) - Makes technical corrections to FFDCA
Corrections
Substances
New §408(k) - Requires EPA to publish a list of substances that
Generally
are generally recognized as safe (GRAS) and that are exempt
Recognized as
from tolerance regulations
Safe
FFDCA-FIFRA
New §408(l) - (1) Directs EPA when possible to coordinate
Coordination
suspension or revocation of a tolerance or exemption with related
necessary action under FIFRA; (2) Requires revocation of
tolerances and exemptions permitting a pesticide residue on a
food within 180 days after EPA has canceled the registration of
that pesticide for that food use due to dietary risks posed by
residues; (3) Requires suspension of a tolerance or exemption
within 60 days of the date a pesticide registration is suspended
under FIFRA; (4) Authorizes EPA to set tolerances for
unavoidable residues of canceled or suspended pesticides; (5)
Declares food is not unsafe solely because it contains a residue
for which the tolerance has been revoked, suspended, or
modified, if the residue results from a legal application of
pesticide and was within the tolerance set at that time and EPA
has not determined that consumption would pose an
unreasonable dietary risk; (6) Requires EPA to issue a tolerance
or exemption, consistent with the safety standard of §408(b)(2)
and (c)(2) and for a limited time, for pesticide residues resulting
from pesticide use during an emergency exemption from
registration requirements under FIFRA §18
Fees
New §408(m) - Retains current requirements for collecting fees
to cover costs of the tolerance program; directs EPA to deposit
fees in the FIFRA Reregistration and Expedited Processing Fund
State and Local
New §408(n) - Preempts state and local regulation of food with
Preemption
residues below the tolerance or which are exempt; allows state
petitions for exceptions; allows state and local warning
requirements for such foods
Consumer Right
New §408(o) - Requires EPA to publish and distribute to large
to Know
retail grocers for public display easily understood information
about the risks and benefits of pesticide residues on food,
including information identifying reasonable nutritional
substitutes for foods with “eligible pesticide residues” for which
special tolerances or exemptions have been established

B-9
Provision
P.L. 104-170
Endocrine
New §408(p) - Directs EPA to develop a screening program to
Effects
determine whether pesticides or other substances have effects in
humans that are similar to effects produced by naturally
occurring estrogens or other endocrine effects; requires EPA to
order testing and submission of reports and to suspend
registration for a registrant’s failure to comply with testing
requirements; authorizes penalties for others who fail to comply
with test orders; requires EPA action when necessary using
existing statutory authority if a substance is found to have an
endocrine effect on humans
Review of
New §408(q) - Requires EPA to review all tolerances and
Tolerances and
exemptions for pesticide residues within 10 years of enactment;
Exemptions
tolerances and exemptions not meeting the standard of §408 as
amended must be revised or revoked; directs EPA to prioritize
reviews based on relative risk to public health
Temporary
New §408(r) - Authorizes EPA to establish a temporary tolerance
Tolerances or
or exemption for a residue that results from pesticides uses
Exemptions
covered by an experimental permit
Savings
New §408(s) - Notes that §408 does not amend or modify TSCA
or FIFRA
Monitoring
§406 - Authorizes additional appropriations for FY1997 through
Pesticide
FY1999 of $12 million (total) for increased monitoring by FDA
Residues on
of pesticide residues in imported and domestic food
Food
Alternative
§407 - Authorizes civil money penalties in lieu of penalties
Enforcement
assessed under FFDCA criminal authorities, seizure authorities,
or injunction authorities for persons who introduce adulterated
food into interstate commerce, but not for growers; penalties may
not exceed $50,000 for individuals and $250,000 for other
persons and may not exceed $500,000 for all such violations
adjudicated in a single proceeding
Title V - Fees
Fees
§501 - Extends EPA authorization to collect FIFRA registration
maintenance fees of $14 million annually through FY2001;
authorizes collection of an additional $2 million per year for
FY1998, FY1999, and FY2000; requires annual full-scale audit
of the reregistration fees collected and expended

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