Order Code RL32218
CRS Report for Congress
Received through the CRS Web
Pesticide Registration and Tolerance Fees:
An Overview
Updated December 19, 2005
Robert Esworthy
Specialist in Environmental Policy
Resources, Science, and Industry Division
Congressional Research Service ˜ The Library of Congress
Pesticide Registration and Tolerance Fees:
An Overview
Summary
The U.S. Environmental Protection Agency (EPA) is responsible for regulating
the sale, use, and distribution of pesticides under the authority of two statutes. The
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) ( 7 U.S.C.136-136y),
a licensing statute, requires EPA to review and register the use of pesticide products
within the United States. The Federal Food, Drug, and Cosmetic Act (FFDCA) (21
U.S.C. 346a) requires the establishment of maximum limits (tolerances) for pesticide
residues on food in interstate commerce. Although U.S. Treasury revenues cover
most costs for administering these acts, fees paid by pesticide manufacturers and
other registrants have supplemented EPA appropriations for many years.
Authority for collecting pesticide fees dates back to the 1954 FFDCA
amendments (P.L. 518; July 22, 1954), which, as passed, required the collection of
fees “sufficient to provide adequate service” for establishing maximum residue levels
(tolerances) for pesticides on food. Authority to collect fees was expanded with the
1988 FIFRA amendments (P.L. 100-532), primarily to help accelerate the
reregistration process (i.e., a reevaluation of pesticides registered prior to 1984). EPA
was authorized to collect a one-time reregistration fee and, through FY1997, annual
maintenance fees. The 1996 amendments to FIFRA and FFDCA, or the Food Quality
Protection Act (FQPA) (P.L. 104-170), extended EPA’s authority to collect the
annual maintenance fees through FY2001, including use of the fees to reevaluate
“old” tolerances (tolerance reassessment). The authority to collect the maintenance
fees expired in FY2001. Congress extended this authority annually through
appropriations legislation until the passage of the Pesticide Registration Improvement
Act (PRIA) of 2003 (P.L. 108-199, Title V of Division G).
The PRIA provisions were included in the Consolidated Appropriations Act for
FY2004 (P.L. 108-199), enacted on January 23, 2004, primarily in response to
ongoing concerns about EPA’s timely review and licensing of pesticides. PRIA
amends FIFRA and modifies the framework for collecting fees to enhance and
accelerate the Agency’s pesticide licensing (registration) activities. In March 2005,
EPA released a report summarizing its first-year progress in implementing the PRIA
provisions. EPA collected $14.7 million in new registration service fees in FY2004
(spending $5 million) and $10.9 million in FY2005. The Agency developed new
procedures for screening pesticide licensing applications and managing pesticide
funds, and it enhanced the existing internal pesticide registration tracking system.
Through the end of FY2005, EPA completed 1,512 registration decisions out of
2,850 submissions subject to PRIA since its enactment in 2004.
EPA proposals to significantly increase revenues supporting these activities by
modifying the fee structure, and attempts to include increased fee revenues in EPA
budget proposals annually from FY1998 through FY2004, were prohibited by
Congress. Despite the enactment of PRIA, proposals to further increase pesticide
fees were included in the President’s FY2005 and FY2006 budget requests. These
proposals also have been rejected by Congress, as reflected in reports accompanying
these appropriations. This report will be updated as events warrant.
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Key Provisions of the Pesticide Registration Improvement Act of 2004 . . . 4
Reauthorization of Pesticide Registrant Maintenance Fees . . . . . . . . . . 4
Registration Services Fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Pesticide Registration Fund . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Prohibition of “Tolerance Fees” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Other Pesticide Fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Pesticide Registration Process Reforms . . . . . . . . . . . . . . . . . . . . . . . . . 6
Statutory Deadline for Reregistration . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Reporting Progress Under PRIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Overview of Pesticide Fee Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
FIFRA and FFDCA Pesticide Fee Collection Authority . . . . . . . . . . . . 9
Other Pesticide Fee Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Proposed Pesticide Fee Authority Modifications . . . . . . . . . . . . . . . . . 11
Pesticide Program Fee Revenues and Appropriations . . . . . . . . . . . . . . . . . 12
Revenues from Pesticide Fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Pesticide Program Appropriated Funds . . . . . . . . . . . . . . . . . . . . . . . . 14
Pesticide Registration and Reregistration Activities Since
the Enactment of PRIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Registration Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Reregistration/Tolerance Reassessment Activities . . . . . . . . . . . . . . . 16
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
List of Figures
Figure 1. EPA Pesticide Program Fee Revenues, FY1985-FY2005
(millions of dollars) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
List of Tables
Table 1. Timeline of Key Legislation and Regulation Regarding
Pesticide Fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Table 2. EPA Appropriations for Pesticide Program Activities
FY2003-FY2006 Enacted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Pesticide Registration and Tolerance Fees:
An Overview
Introduction
The collection of fees to support U.S. Environmental Protection Agency (EPA)
pesticide program activities has been a complex issue for more than 20 years.
Authorities to collect fees in addition to appropriated funds have been provided over
the years in part to accelerate the Agency’s review efforts and to fund its increasing
statutory responsibilities. Recent Administration proposals to modify and
significantly increase pesticide fees have been at odds with the views of a range of
stakeholders and controversial in Congress. Congress acted to address the issues of
concern through pesticide fee provisions included in the Consolidated Appropriations
Act of FY2004, enacted on January 23, 2004 (P.L. 108-199). However, the
Administration has continued to propose approaches for additional fee revenues.
General U.S. Treasury revenues are used to cover most of the administrative
costs of EPA’s pesticide program, which implements requirements under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C.136-136y) and the
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a), as amended.
However, fees also have been imposed on those who manufacture and distribute
pesticides in U.S. commerce (i.e., registrants1) to supplement EPA appropriations.
Provisions in the Consolidated Appropriations Act of FY2004, which have become
known as the Pesticide Registration Improvement Act of 2003 or PRIA, modified
existing pesticide fee authority to support specified activities and process
improvements in an effort to achieve more timely completion of EPA’s statutory
obligations under the authority of FIFRA and FFDCA.
In March 2005, EPA reported, as required,2 its first fiscal year (January 23, 2004
through September 30, 2004) progress implementing PRIA. “The Pesticide
Registration Improvement Act (PRIA) Implementation: 2004 Annual Report”
(referred to throughout this report as EPA’s PRIA implementation report) provides
information about the registration process and EPA’s efforts to improve the process,
as well as the status of its registration and reregistration activities.
This CRS report provides a historical overview of federal authority regarding
pesticide fees, including the amount of fee revenues collected over time, and
1 A registrant is defined as a person who has registered any pesticide pursuant to the
provisions of FIFRA.
2 Under Section 33(k) of PRIA, EPA is required to publish an annual report describing
actions taken under this section during the past fiscal year, and is directed to include several
elements. The report can be accessed at [http://www.epa.gov/pesticides/fees/], accessed
December 6, 2005.
CRS-2
summarizes the key elements of PRIA. For a more complete overview of the federal
pesticide laws, refer to CRS Report RL31921, Pesticide Law: A Summary of Statutes,
by Linda-Jo Schierow.
Background
FIFRA is a licensing statute that requires EPA to register pesticide products
before they can be sold, used, and distributed within the United States. EPA
evaluates proposed pesticide registrations under a set of science-based safety
standards. Before a registration can be granted for a “food use” pesticide, FFDCA3
requires that a tolerance (the maximum amount of pesticide residue permitted in or
on food and feed) or tolerance exemption be in place. Under the standards
introduced by the 1996 amendments to FIFRA and FFDCA (the Food Quality
Protection Act or FQPA; P.L. 104-170), EPA establishes tolerances through
rulemaking based on risk assessments and human health criteria to ensure a
“reasonable certainty of no harm.” For pesticides that are not used on food, FIFRA
requires EPA to determine whether and under what conditions the proposed pesticide
use would present an unreasonable risk to human health or the environment. EPA
is also required to reevaluate older, registered pesticides (i.e., reregistration)4 and to
reassess existing tolerances (i.e., tolerance reassessment)5 to ensure they meet current
safety standards. Congress has amended FFDCA and FIFRA over time to authorize
the collection of fees to supplement appropriated funds for these pesticide review
activities.
The 1954 amendments to FFDCA6 authorized the collection of fees to provide
adequate service for establishing maximum allowable residue levels (tolerances) for
pesticides on food, and they remain the basis for current “tolerance fee” authority.
Congress amended FIFRA in 1988 (P.L. 100-532), authorizing the collection of a
one-time “reregistration fee” and, through FY1997, annual “maintenance fees” in an
effort to accelerate reregistration (review of pesticides registered before 1984). In the
1996 amendments to FIFRA and FFDCA (FQPA; P.L. 104-170), Congress,
concerned with the continued pace of reregistration, extended EPA’s authority to
collect the annual maintenance fees through FY2001. In addition, in an attempt to
provide resources to address increased responsibilities of implementing new safety
standards introduced with the 1996 amendments, maintenance fee authority was
expanded to allow a portion of the collected revenues to be used to support the
reevaluation of “old” existing tolerances (tolerance reassessment). These pesticide
maintenance fees, along with tolerance fees based solely on petitions for establishing
new tolerances, were the only pesticide fees collected by EPA during the eight years
3 FFDCA Sections 408 and 409.
4 The 1988 amendments to FIFRA (P.L. 100-532) define “re-registration” as re-evaluation
of pesticides registered prior to 1984.
5 FIFRA and FFDCA as amended in 1996 (FQPA; P.L. 104-170), “tolerance reassessments”
is defined as those tolerances in existence as of August 1996.
6 Section 408(o) as amended the Pesticide Residue Amendment of 1954 (P.L. No. 518, 21
U.S.C. 346(a)). The current authority resides in FFDCA Section 408(m), per the 1996
amendments to FFDCA (FQPA).
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(FY1996-FY2003) prior to the enactment of PRIA. (A detailed overview of pesticide
fee authorities and collected revenues is presented below).
The current (and previous) Administration has proposed modifications to the fee
structure to significantly increase revenues, primarily to obtain supplemental
resources to support increased administrative costs associated with implementing the
requirements of FQPA. Proposals generally focused on finalizing a 1999 EPA
proposed rule7 to substantially revise tolerance fees and on a recommendation that
Congress discontinue the legislative prohibition on pesticide registration fee
authority8 promulgated in 1988. Shortly after its promulgation, the final 1988
pesticide registration fee regulation was challenged in court by the Chemical
Specialties Manufacturers’ Association,9 which questioned the appropriateness of the
statutory authority cited. Collection of these registration fees as promulgated was
temporarily suspended through FY1997 by the 1988 amendments to FIFRA (Section
4[i][6]). Collecting registration fees as promulgated in 1988 continued to be
prohibited subsequently by the 1996 FIFRA/FFDCA amendments (FQPA) and in
provisions of annual appropriations bills, including the PRIA provisions in the
FY2004 Consolidated Appropriations.
The Administration’s proposed 1999 regulation to restructure the collection of
tolerance fees met with similar resistance. Industry groups questioned the authority
to expand fee collection under FFDCA10 and the lack of a clearly defined schedule
of specific Agency activities to be supported by fee revenues. These groups also
generally opposed the EPA’s justification for proposing a tenfold increase, requiring
retroactive fee payments, and imposing fees for inert ingredients.11 Congress initially
prohibited promulgation of the tolerance fee rule in EPA’s FY2000 appropriations
(P.L. 106-377). Similar proposals to increase tolerance fees in EPA’s annual budget
requests from FY2001 to FY2004 were prohibited each year through appropriations
legislation. PRIA prohibits collection of any tolerance fees through FY2008.
Despite this prohibition, the Administration proposed similar additional tolerance fee
revenues in FY2005 and FY2006 EPA budget requests. In the first session of the
109th Congress, language contained in the FY2005 supplemental appropriations for
military funding enacted May 11, 2005 (P.L. 109-13, Sec. 6033), bans EPA from
going forward with rulemaking for collecting pesticide tolerance fees.
7 U.S. EPA, 64 Federal Register 31039-31050, June 9, 1999.
8 EPA promulgated a rule for collecting registration fees under the authority of the
Independent Offices Appropriation Act (IOAA) of 1952 (31 U.S.C. 9701). See Subpart U
of CFR part 152, at 53 Federal Register 19108, May 26, 1988.
9 Chemical Specialties Manufacturers Association (now the Consumer Specialty Products
Association) v. EPA, No. 88-1525. D.D.C., July 25, 1988.
10 Several industry groups disagreed and were concerned with EPA’s interpretation that the
statute provided authority to collect 100% of the cost of tolerance reassessment using fees.
(EPA Docket # OPPT-301151 and OPPT-301151B.)
11 Inert ingredients can be solvents or surfactants and often compose the bulk of the pesticide
product. Some inerts are known to be toxic, and some are known to be harmless, but EPA
lists most in the category “inerts of unknown toxicity.” (U.S. EPA website at
[http://www.epa.gov/opprd001/inerts/], accessed December 8, 2005).
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Key Provisions of the Pesticide Registration Improvement
Act of 2004
The “Pesticide Registration Improvement Act of 2003,” or PRIA, temporarily
supersedes the 1988 registration fee authority,12 and suspends tolerance fee authority
under FFDCA through FY2008. Enacted as Title V of Division G of the FY2004
Consolidated Appropriations Act (P.L. 108-199), PRIA amends FIFRA and modifies
the framework for collecting fees to enhance and accelerate EPA review of pesticide
applications registration and reregistration. PRIA seemed to address many of the
issues associated with other recently proposed modifications, and it received the
support of a large cross section of stakeholders, including organizations representing
manufacturers and formulators, agricultural producers, and environmental and public
interests.13 These groups jointly favored the expected reforms and acceleration of
EPA’s decision process, the simplification of the fee authority, and the detailed
schedule of activities determining the allocation of fees collected. In addition to
extending the existing authority to collect maintenance fees through FY2008 at
initially increasing, then declining, levels, PRIA
! provides new authority for EPA to collect “registration services
fees,” which would be phased out at the end of FY2010;
! prohibits collection of any tolerance fees through FY2008;
! requires EPA to identify reforms to the pesticide registration process
to substantially reduce the decision review period; and
! extends the statutory deadline for completing reregistrations for
active ingredients that do not require tolerances to October 3, 2008.
Reauthorization of Pesticide Registrant Maintenance Fees. Annual
maximum maintenance fees per registrant, and in aggregate, will increase each year
above the FY2003 levels for the first three years and will decline in the final two
years.14 For example, the annual maximum fee for registrants with less than 50
pesticide registrations increased from $55,000 in FY2003 to $84,000 in FY2004, and
to $87,000 in FY2005 and FY2006. That fee will decline in FY2007 to $68,000
before returning to the FY2003 level of $55,000 in FY2008. Similar changes from
FY2003 fee levels will occur for registrants with more than 50 registrations and for
small businesses (as redefined in PRIA). The ability to obtain waivers will continue
for public health pesticides. The annual statutory aggregate limit increased from
$21.5 million for FY2003 to $26 million for FY2004, and $27 million for FY2005
and FY2006; it will decline to $21 million for FY2007 and $15 million for FY2008.15
12 PRIA (P.L. 108-199) removes the prohibition on “other fees” by amending FIFRA Section
4(i)(6), replacing Sections 33 and 34 (7 U.S.C. 136x and 136y) through 2010. Thus the
legislation temporarily replaces registration fee authority codified in 1988 (Subpart U of
CFR part 152), through 2010.
13 September 12, 2003, letter addressed to President George W. Bush, from a coalition of 30
organizations representing industry and public interests.
14 See P.L. 108-199, Division G, Title V, Section 501(c)(1)(D) and (E).
15 Under the provisions of the 1988 amendments to FIFRA (P.L. 100-532), EPA calculates
(continued...)
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Maintenance fees continue to be assessed on existing pesticide registrations to
fund reregistration, tolerance reassessment and expedited processing of “similar”
pesticides16 and public health pesticides. The PRIA provisions in the FY2004
Consolidated Appropriations Act also amend FIFRA (7 U.S.C. 136a-l[k][3]) to
explicitly designate the use of a portion of maintenance fees for the review of “inert”
ingredients.17 The 1996 FQPA placed greater emphasis on inert ingredients and
clarified that these chemicals are covered by the definition of a pesticide chemical
under FFDCA (section 201[q][1]), but not FIFRA. Therefore EPA must make a
determination regarding the establishment of tolerances for inert ingredients.
Registration Services Fees. PRIA also inserted a new section (Section 33)
in FIFRA establishing registration “services” fees that apply only to new pesticide
applications (submitted on or after the effective date of PRIA), with provisional
transitional allowances for pending applications. These fees are expected to cover
a portion of the cost for review and decision making associated with a registration
application, including associated tolerance determinations. As defined in PRIA,
these costs include EPA staff, contractors, and advisory committees engaged in
relevant activities for pesticide applications, associated tolerances, and corresponding
risk and benefits information and assessment. Authority to collect service fees ends
at the end of FY2008, with phase-out authority at reduced levels for FY2009 and
FY2010.
The EPA Administrator is directed to publish a detailed schedule of covered
pesticide applications and corresponding registration service fees, as reported in the
September 17, 2003, Congressional Record (S11631 through S11633). The amount
of the fees vary depending on the specific “service” required. As required by the
statute, EPA published the schedule of covered applications and registration service
fees on March 17, 2004 (69 Federal Register 12771). In June 2005, EPA published
a Federal Register Notice (70 Federal Register 32327) announcing a 5% increase in
pesticide registration service fees, as authorized by PRIA (P.L. 108-199, Title V of
Division G, section 33[b][6][B]). The new schedule applies to pesticide registration
applications received on or after October 1, 2005.
Pesticide Registration Fund. PRIA establishes a Pesticide Registration
Fund (“the fund”) in the U.S. Treasury, to be made available to EPA for purposes
defined in the legislation, without fiscal year limitation. PRIA includes a mandatory
adjustment (5% increase) by FY2006 and provisions requiring that a portion of the
15 (...continued)
and adjusts the amount of annual maintenance fees collected per registrant, based on the
number of registrants and the number of pesticide registrations, which is determined by the
agency at the beginning of each fiscal year.
16 Also referred to as “Me-too” pesticides; see FIFRA section 4(k)(3)(i), “the initial or
amended registration of an end-use pesticide that, if registered as proposed, would be
identical or substantially similar in composition and labeling to a currently-registered
pesticide....”
17 Approximately $3.3 million for FY2004 through FY2006, and between 1/8 and 1/7 of the
annual aggregate maintenance fee amount authorized for FY2007 and FY2008 can be used
for the review of inert ingredients (P.L.108-199, Division G, Title V, Section 501[e]).
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amount in the fund (not less than $750,000 and not more than $1 million) be used to
enhance scientific and regulatory activities for worker protection for FY2004 through
FY2008. An additional portion of the fund (not to exceed $500,000) is to be used for
the evaluation of new inert ingredients.
Waivers or reductions of registration service fees for minor uses or small
businesses are authorized in Section 33(b)(7) of PRIA, as are partial fee refunds,
when applications are withdrawn or at the Administrator’s discretion. EPA
developed guidance for applying for waivers of the registration service fee and
provided relevant information on a dedicated website. EPA also established
formulae for reducing certain registration service fees.18
To assure that the appropriated funds are not reduced in lieu of fee revenues for
the first three fiscal years (FY2004-FY2006), the legislation prohibits authorizing
registration services fees unless the amount of appropriations for specified functions
conducted by the EPA Office of Pesticide Programs in those years is no less than the
corresponding FY2002 appropriation.19 Funding appropriated for EPA for FY2004
(P.L.108-199), FY2005 (P.L.108-447), and FY2006 (P.L. 109-54), has met this
requirement.
Prohibition of “Tolerance Fees”. Authority for collecting tolerance fees
dates back as far as the 1954 amendments to FFDCA (P.L. 518; July 22, 1954),
which, as passed, required the collection of fees “sufficient to provide adequate
service” for establishing maximum residue levels (tolerances) for pesticides on food.
(See below for a more detailed discussion.) PRIA prohibits EPA from collecting
“any” tolerance fees under the authority of section 408(m)(l) of FFDCA (21 U.S.C.
346a[m][l]) through FY2008. Under PRIA, fee revenues to support tolerance review
activities are allocated from maintenance fees (for tolerance reassessments) and
registration service fees (for new and amended tolerances) for the next five years. On
March 17, 2004, EPA published a notice suspending the collection of tolerance fees
(69 Federal Register 12542).
Other Pesticide Fees. PRIA also removes the prohibition on “other fees”
by amending FIFRA Section 4(i)(6), replacing Sections 33 and 34 (7 U.S.C. 136x
and 136y) through 2010. Specifically, the collection of fees under the registration fee
authority codified in 1988 (Subpart U of CFR part 152) is temporarily replaced and
essentially prohibited by this provision.
Pesticide Registration Process Reforms. In conjunction with the
increased fee revenues, a key provision of the legislation is the requirement for EPA
to identify reforms20 to the Agency’s pesticide registration process with the intent of
18 Guidance for service registration fee waivers and reductions can be accessed at
[http://www.epa.gov/pesticides/fees/questions/waivers.htm]; information regarding the fee
reduction formula can be accessed at [http://www.epa.gov/pesticides/fees/fee_reduction.
htm]. Both websites were accessed December 5, 2005.
19 Ibid., see Section 33(d) Assessment of Fees.
20 Ibid., see Sections 33(e) Reforms to reduce Decision Time Periods, and (f)Decision
(continued...)
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reducing the current decision review period. The EPA Administrator is directed to
publish in the Federal Register a schedule of decision review periods for pesticide
registration activities covered by this legislation. The schedule is to be the same as
the applicable schedule appearing in the September 17, 2003, Congressional Record
(S11631 through S11633). As discussed earlier in this report, a detailed schedule of
covered pesticide applications, and corresponding registration service fees, was
published on March 17, 2004 (69 Federal Register 12771). In its first PRIA
implementation annual report released in March 2005, EPA described its efforts and
accomplishments as of the end of FY2004 (see below).
Statutory Deadline for Reregistration. Section 501(c)(5) of PRIA
modifies FIFRA (7 U.S.C. 136a-1[i][5][H]) with regard to completion deadlines for
reregistration. Reregistration of active ingredients that require tolerances or
exemptions from tolerances must be completed by August 3, 2006, as required by
FFDCA (Section 408[q][1][C]) for tolerance reassessment. All other reregistrations
must be completed no later than October 3, 2008.
Reporting Progress Under PRIA. PRIA requires EPA to publish an annual
report describing actions taken during each fiscal year. EPA is directed to include
several elements in the report, including progress made in carrying out its obligations
under the act, a description of the staffing and resources related to the costs
associated with the review and decision making pertaining to applications, and the
progress in meeting the reregistration and tolerance reassessment timeline
requirements. In March 2005, EPA released a report summarizing its first year
progress implementing the provisions of the PRIA (The Pesticide Registration
Improvement Act [PRIA] Implementation: 2004 Annual Report), covering the period
from January 23, 2004, through September 30, 2004.21 According to the EPA report,
by the end of FY2004, the Agency collected $14.7 million in new “registration
service” fees, spending roughly $5 million. The remaining balance of $9.7 million
was carried forward to FY2005. EPA reported the initiation of several process
improvements and completion of 208 decisions subject to PRIA during the fiscal
year, and 1,081 applications subject to PRIA pending in the Agency’s registration
queue.
Overview of Pesticide Fee Authorities
Various changes and proposed changes to pesticide fee authority led up to the
provisions in PRIA. Fees collected by EPA over time to support the pesticide
program have included tolerance fees, registration fees, reregistration fees, and
maintenance fees. Since 1996, EPA has collected tolerance fees, primarily for the
establishment of pesticide residue limits (tolerances) on food, and maintenance fees,
primarily for reregistration reviews and reassessment of existing tolerances. Table
1 provides a timeline of key pesticide fee authorities and implementation regulations;
the following sections provide a brief description of these actions.
20 (...continued)
Review Time Periods.
21 See [http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2004.htm],
accessed December 5, 2005.
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Table 1. Timeline of Key Legislation and Regulation Regarding
Pesticide Fees
Year
Legislation/Regulation
Pesticide Fee Authority/Action
1952
Independent Appropriations Act
Authorizes the head of each agency to prescribe
of 1952 (IOAA; 31 U.S.C. 9701)
regulations establishing a charge for a service or thing
of value provided by the agency.
1954
Federal Food Drug and Cosmetic
Authorizes fees to accompany initial or modified
Act, amended (FFDCA; P.L. No.
petitions for establishing tolerances under FFDCA
518, 21 U.S.C. 346 [a])
section 408 (o).
1986
EPA Registration Fee
Proposed a schedule of fees to accompany pesticide
Regulation: Proposed
registration and experimental use permit applications,
(51 Federal Register 42974, Nov.
citing the authority of IOAA.
26, 1986)
1988
EPA Registration Fee: Final
Establishes fees to accompany pesticide registration
Regulation (40 CFR 152[u] and
and experimental use permit applications; authority
40 CFR 172)
suspended by the FIFRA amendments passed later
that same year (1988).
Federal Insecticide, Fungicide
Authorizes reregistration and expedited processing
and Rodenticide Act, amended
fund: a one-time “reregistration” fee and annual
(FIFRA; P.L. 100-532)
“maintenance” fees through FY1997. Prohibited
collection of other fees (including “registration fees”
as defined in 40 CFR 152[u] and 40 CFR 172).
1996
Food Quality Protection Act
Extends authorization for maintenance fees through
(FQPA) (P.L. 104-170): FIFRA
FY2001. FFDCA authority (Section 408[m])
and FFDCA, amended
amended to cover costs of all tolerance activities and
directs EPA to deposit funds collected as
maintenance fees to be used for reassessing existing
tolerances as needed. Prohibits collection of
registration fees as defined in 40 CFR 152(u) and 40
CFR 172) through FY2001.
1999 EPA Tolerance Fee Rule:
Proposed establishment of a tenfold increase in
Proposed (64 Federal Register
existing tolerance fees and new “tolerance
31039-31050, June 9, 1999)
reassessment” fees, including fee for reviewing
tolerances for inert ingredients. Fees, to be collected
retroactively from 1996, would supplement
authorized maintenance fees.
FY2000 EPA Appropriations
Prohibits promulgation of a final tolerance fee rule
(P.L. 106-377)
based on EPA’s 1999 proposal.
2000
FY2001 EPA Appropriations
Continues prohibition on promulgation of a final
(P.L. 106-774)
tolerance fee rule as proposed in 1999.
2001
FY2002 EPA Appropriations
Continues the prohibition on promulgation of a final
(P.L. 107-73)
tolerance fee rule based on the 1999 proposal and on
collection of registration fees as codified in 1988.
Maintenance fees reauthorized and aggregate limit
increased.
CRS-9
Year
Legislation/Regulation
Pesticide Fee Authority/Action
2002
Farm Security Act
Senate-proposed pesticide fee authorities considered
(P.L. 107-171)
and deleted in Conference. Conferees questioned the
legal basis for EPA’s June 9, 1999, proposed rule (64
FR 31039) to collect tolerance fees retroactively and
encouraged EPA to withdraw the proposal. (H.Rept.
107-424).
2002- EPA Appropriations: FY2003
Prohibits promulgation of a final tolerance fee rule
2003
(P.L. 108-10) and FY2004
based on the 1999 proposal. Continued prohibition of
Continuing Resolution (P.L. 108-
the collection of registration fees as codified in 1988.
135; through Jan. 31, 2004)
Maintenance fees reauthorized; maximum aggregate
levels increased.
S. 1664 and H.R. 3188, proposed;
Would have authorized new a registration service fee,
the basis for PRIA provisions
reauthorized maintenance fees, required pesticide
later included in the FY2004
regulation process reforms, and prohibited collection
Consolidated Appropriations Bill
of tolerance fees.
(P.L. 108-199)
2004
FY2004 Consolidated
Authorizes new registration “service” fee,
Appropriations Bill (P.L.
reauthorizes maintenance fees, requires pesticide
108-199; Division G, Title V),
regulation process reforms, and prohibits the
enacted January 23, 2004
collection of tolerance fees.
FY2005 Consolidated
Provides continued authorization for the collection of
Appropriations Act FY2005 (P.L.
pesticide fees pursuant to P.L.108-199.
108-447), enacted December 8,
2004
2005
FY2005 supplemental
Bans EPA from going forward with rulemaking for
appropriations for military
collecting pesticide tolerance fees as prohibited by
funding (P.L. 109-13, Sec. 6033)
PRIA.
enacted May 11, 2005
2006
Interior, Environment, and
Provides continued authorization for the collection of
Related Agencies
pesticide fees pursuant to P.L.108-199.
Appropriationsa Act for FY2006
(P.L. 109-54), enacted August
25, 2005
Source: Prepared by the Congressional Research Service from the relevant laws and Federal Register
Notices.
a. During the first session of the 109th Congress, the House and Senate Appropriations Committees
reorganized their subcommittees, including placing EPA’s appropriation under the Interior
subcommittee after eliminating the VA-HUD and Independent Agencies subcommittee.
FIFRA and FFDCA Pesticide Fee Collection Authority. Authority for
the collection of pesticide fees dates back as far as the 1954 amendments to
CRS-10
FFDCA.22 At the time, Section 408(o)23 required the collection of fees to cover the
costs of establishing maximum residue levels (“tolerances”) for pesticides on food.
Until 1988, these tolerance fees were the only pesticide fees collected by EPA.
The 1988 amendments to FIFRA (P.L. 100-532) extensively expanded pesticide
fee authority. The amendments included a nine-year schedule to accelerate the
process of reregistration. To help defray the costs of the accelerated process, EPA
was authorized to collect a one-time reregistration fee from producers for their
pesticide active ingredients registered prior to 1984, and annual maintenance fees
from pesticide registrants through FY1997, for each registered pesticide product. The
amounts of fees per registrant were tiered, depending on the number of registrations
per registrant, as determined by EPA each fiscal year.
Congress amended FIFRA in 1996 (FQPA; P.L. 104-70), extending EPA’s
authority to collect the annual maintenance fees through FY2001. FQPA also
expanded the authority under FFDCA to include the use of fees for purposes of
reevaluating “old” tolerances (tolerance reassessment). FQPA requires EPA to
ensure “reasonable certainty” of “no harm,” analyze aggregate and cumulative effects
of pesticides, and to apply safety factors for children. The new requirements
introduced a host of responsibilities for EPA, particularly when establishing new
tolerances and reassessing old tolerances.24 Since its expiration September 30, 2001,
the statutory authority for maintenance fees has been extended in annual EPA
appropriations bills prior to the enactment of the PRIA provisions.25
Other Pesticide Fee Authority. In May 1988, prior to the 1988 FIFRA
amendments, EPA had promulgated a final pesticide registration fee regulation,26
citing the authority of the Independent Offices Appropriation Act (IOAA) of 1952
(31 U.S.C. 9701). Intended to defray increasing administrative costs of pesticide
registration reviews, the final rule included a prescribed schedule of fees to be
submitted with each application for registration, amended registration, or
experimental use permit. Registration fees were to be deposited in the U.S. Treasury
and not directly available to EPA. The regulation was challenged in court by the
Chemical Specialties Manufacturers’ Association,27 and the collection of registration
fees under this authority was temporarily suspended through FY1997 by the 1988
amendments to FIFRA (Section 4[i][6]). Collecting registration fees under this
22 Pesticide Residue Amendment of 1954, P.L. No. 518, 21 U.S.C. 346(a).
23 This authority currently resides in FFDCA Section 408(m) (1996 FQPA).
24 See CRS Report RS20043, Pesticide Residue Regulation: Analysis of Food Quality
Protection Act Implementation, by Linda-Jo Schierow.
25 The FY2001 statutory aggregate level of $14 million established by the 1988 FIFRA
amendments was increased to $17 million in FY2002 (P.L. 107-73) and $21.5 million in
FY2003 (P.L. 108-10). The final Continuing Resolution for FY2004 (P.L. 108-135)
extended the maintenance fee as authorized in FY2003 (see H.J.Res. 69, Section 118).
26 40 CFR 152(u) and 40 CFR 172.
27 Chemical Specialties Manufacturers Association (now the Consumer Specialty Products
Association) v. EPA, No. 88-1525. D.D.C., July 25, 1988. The lawsuit has been held in
abeyance since the passage of the 1988 FIFRA amendments.
CRS-11
authority continued to be prohibited through FY2001 by the 1996 FIFRA/FFDCA
amendments (FQPA) and, subsequently, by annual appropriations bills from FY2002
through the FY2004 Continuing Resolution.28
Proposed Pesticide Fee Authority Modifications. In June 1999, EPA
proposed a rule restructuring tolerance fees29 in an effort to cover the cost of
establishing initial tolerances and tolerance reassessments, including tolerance
activities for “other” ingredients (namely, inert ingredients30). EPA proposed as
much as a tenfold increase and the retroactive payment of fees for tolerance petitions
submitted and reassessments initiated after FQPA was enacted in August 1996.
Industry groups generally opposed the proposal. According to comments submitted
to EPA, several industry groups disagreed and were concerned with, among other
issues, EPA’s interpretation that the statute provided authority to collect 100% of the
cost of tolerance reassessment using fees. These groups also generally opposed
EPA’s justification for the tenfold increase in fees, the imposition of fees
retroactively, and the potential effects of imposing fees for inert ingredients.31
The 106th Congress prohibited promulgation of the tolerance fee rule in EPA’s
FY2000 appropriations (P.L. 106-74, Sec. 432). The 107th Congress considered
approaches to revise the overall fees structure for pesticide programs and
incorporated one approach in a manager’s amendment to the Senate version of the
2002 farm bill (S. 1731). The conference substitute deleted the fee provisions and
was not included in the final Farm Security and Rural Investment Act of 2002 (P.L.
107-171). In the conference report accompanying the final bill (H.Rept. 107-424, p.
666), the managers “strongly encouraged” EPA to withdraw its proposed tolerance
fee rule and to instead work with the appropriate committees for a solution. Similar
proposals to increase tolerance fees, included in EPA’s annual budget requests for
FY2001 through FY2004,32 have been prohibited each year by Congress in
appropriations acts.33 As discussed earlier in this report, the PRIA provisions enacted
in 2004 prohibit the collection of any tolerance fees through FY2008.
Despite the PRIA prohibition on additional pesticide fees, the Administration
proposed increased fees above those provided under PRIA in the FY2005 and
FY2006 budget requests for EPA. The 108th Congress rejected the President’s
FY2005 budget proposal to reinstate pesticide fees in the conference report on the
28 Appropriations bills for VA-HUD and Independent Agencies passed by the 107th Congress
(P.L. 107-73) and the 108th Congress (P.L. 108-10; P.L. 108-135, Continuing Resolution for
FY2004, expired January 31, 2004) contained similar prohibitive language.
29 64 Federal Register 31039-31050, June 9, 1999.
30 The 1996 FQPA clarified that “inert” ingredients are covered by the definition of a
pesticide chemical under FFDCA (section 201[q][1]).
31 EPA Docket # OPPT-301151 and OPPT-301151B.
32 See EPA Budget Proposals and Congressional Justifications for FY2001-FY2005 on
EPA’s website ([http://www.epa.gov/ocfo/budget/index.htm]), accessed December 9, 2005.
33 Appropriations bills for VA-HUD and Independent Agencies passed by the 106th Congress
(P.L. 106-377), the 107th Congress (P.L. 107-73), and the 108th Congress (P.L. 108-7, P.L.
108-135, FY2004 Continuing resolution) contained similar prohibitive language.
CRS-12
Consolidated Appropriations Act for FY2005 (H.Rept. 108-792, p. 1597). In the first
session of the 109th Congress, language contained in the FY2005 supplemental
appropriations for military funding enacted May 11, 2005 (P.L. 109-13, Sec. 6033),
banned EPA from going forward with rulemaking for collecting pesticide tolerance
fees as prohibited by PRIA.
The President’s FY2006 budget, submitted to Congress in February 2005,
included $46.0 million in the form of “anticipated” revenues (offsetting receipts) to
be derived from changes to fees for pesticide registrations.34 The pesticide fees
proposed by the Administration for FY2006 would be in addition to those currently
authorized under PRIA. The FY2006 appropriations bill for Interior, Environment,
and Related Agencies (P.L. 109-54, H. Rept.109-188), which includes EPA and was
enacted August 2, 2005, did not reflect the Administration’s additional anticipated
pesticide fee revenues. The proposed fee changes in the Administration’s request
would have required congressional approval through the enactment of legislation. In
its report on the bill, the House Appropriations Committee noted that no relevant
legislation had been proposed and commented that EPA should not continue to spend
time and resources proposing such actions in conflict with current authority (H.Rept.
109-80, p. 105-106).
Pesticide Program Fee Revenues and Appropriations
The historical appropriated funding and fee revenues for the pesticide program
activities provides context for the discussion of fees imposed on pesticide registrants
to supplement EPA-appropriated revenues. The two sections that follow provide
more detailed information regarding pesticide fee revenues over time and funds
appropriated for EPA pesticide program activities in recent years.
Revenues from Pesticide Fees. Registration applications received on or
after March 23, 2004, were subject to the new service fees under PRIA. In The
Pesticide Registration Improvement Act (PRIA) Implementation: 2004 Annual
Report, EPA indicates that it collected $14.7 million in registration “service,”
spending roughly $5.0 million, during FY2004. The remaining balance of the fee
revenue has been carried forward to FY2005. EPA collected $10.9 million in
FY2005. EPA collected $25.9 million in maintenance fees in FY2004 and $27.9
million in FY2005. EPA initiated collection of maintenance fees at the beginning of
FY2004 under preexisting authority, prior to the reauthorization provisions included
in PRIA.
Prior to the enactment of PRIA, the FY2003 appropriations were supplemented
by an estimated $23.0 million in authorized fees, including $21.5 million in
maintenance fees and $1.5 million in tolerance fees, primarily for establishing new
tolerances. The amount of pesticides fees collected over the years varied, depending
on the statutory authority at the time. Figure 1 provides a graphic illustration of the
amount of tolerance fees, registration fees (only collected for a short period during
34 Executive Office of the President, Office of Management and Budget, Major Savings and
Reforms in the President’s 2006 Budget, pp. 222-224. Available online at
[http://www.whitehouse.gov/omb/budget/fy2006], accessed December 5, 2005.
CRS-13
FY1998), reregistration fees, maintenance fees, and registration service fees collected
during the period FY1985 through FY2005, before and after the enactment of PRIA.
The highest combined amount collected from the three fees for one year prior to the
enactment of PRIA was an estimated $39.1 million in 1990, the peak year for
collection of the one-time reregistration fees.
Figure 1. EPA Pesticide Program Fee Revenues, FY1985-
FY2005
(millions of dollars)
$
$
n
millio
Source: Prepared by Congressional Research Service (CRS) with information from the U.S. EPA
Office of Prevention, Pesticides, and Toxic Substances.
* Tolerance fees for FY1985-FY1988 are based on the average number of petitions per year (8-12)
and the average fee per petition ($150,000).
**Maintenance fees are capped by legislation for each fiscal year: $14 million for FY1989-FY1997;
$16 million for FY1998-FY2000; $14 million for FY2001; $17 million for FY2002; and $21.5
million for FY2003. PRIA capped maintenance fees at $26 million for FY2004 and $27 million
for FY2005.
The annual tolerance fee collected from each applicant is based on the specific
actions required to process a submitted application and varies depending on the
number and type of petitions received by the Agency in a given year. The amounts
CRS-14
have been adjusted over time, based on an inflation calculation defined in statute.35
For the 20 years prior to the enactment of PRIA, annual tolerance fees collected by
EPA have averaged about $1.8 million.
Reregistration fees varied considerably and were based, among other things, on
whether the pesticide was an active ingredient registered for a major food or feed use
or whether it was registered only for nonfood or nonfeed uses. The one-time active
ingredient fee for reregistration ranged from $0 for a pesticide used exclusively for
minor uses and for certain antimicrobial active ingredients to $150,000 for a major
food or feed use active ingredient. By 1994, all authorized one-time reregistration
fees had been collected, an estimated total of $31.64 million (see Figure 1 above).
The annual amount collected per registration for maintenance fees is set in
statute, dependent on the number of registrations held by a registrant. The fee
amount is subject to adjustment by EPA, based on the annual aggregate limit, also
established by statute. The initial 1988 authorization for maintenance fees set the
annual aggregate at $14.0 million for the nine-year period from FY1989 to FY1997.
The 1996 FQPA authorized collection of an additional $2 million (maximum
aggregate of $16 million) per year for FY1998, FY1999, and FY2000, and returned
to the original aggregate limit of $14 million in FY2001. The statutory authority for
maintenance fees expired September 30, 2001, but was reauthorized in the annual
appropriations bills. The amount authorized was increased to $17 million in FY2002
(P.L. 107-73) and $21.5 million in FY2003 (P.L. 108-7) and FY2004 (continuing
resolution P.L. 108-135,36 through January 31, 2004). Figure 1 indicates that EPA
generally collected the maximum aggregate limit as set by the statute in a given year.
Pesticide Program Appropriated Funds. FY2006-appropriated funding
(P.L. 109-54) for EPA’s pesticide program activities is allocated within three of the
eight EPA appropriations accounts, as has been the case in recent previous fiscal
years: Science and Technology (S&T), Environmental Programs and Management
(EPM), and State and Tribal Assistance Grants (STAG). For the three accounts
combined, Congress provided more funding for FY2006 for EPA’s pesticide program
activities than it appropriated in each of the three previous fiscal years. The
conference report (H. Rept.109-188) specifies FY2006 funding within these accounts
for five pesticide program areas, the same as those presented in the President’s
FY2006 budget request and described in detail in the U.S. Environmental Protection
Agency FY2006 Justification of Appropriation Estimates for the Committee on
Appropriations.37 Table 2 shows enacted appropriations for FY2003 through
FY2006, within the three appropriations accounts for the five EPA pesticide program
activities.
35 Tolerance fees can be adjusted annually, based on annual percentage changes in federal
salaries (40 CFR 180.33[o]). The most recent adjustment in May of 2003 was an increase
of 4.27%, based on the 2003 pay raise for General Federal Schedule (GS) employees in the
Washington DC/Baltimore MD metropolitan area (68 FR 24370, May 7, 2003).
36 See also P.L. 108-84, September 30, 2003, and H.J.Res. 69 Section 118, 108th Congress
1st Session (2003).
37 EPA-205/R-05-001, can accessed at [http://www.epa.gov/ocfo/budget/2006/2006cj.htm].
CRS-15
Table 2. EPA Appropriations for Pesticide Program Activities
FY2003-FY2006 Enacted
(million dollars)
FY2003
FY2004
FY2005
FY2006
Pesticide Program Activities by
Enacted
Enacted
Enacted
Enacted
EPA Appropriations Account
P.L. 108-7
P.L. 108-199 P.L. 108-447 P.L. 109-54
Environmental Program Management(EPM)
Registration
$40.4
$40.8
$39.2
$41.5
Reregistration
$48.5
$51.7
$51.3
$55.0
Field Programs
$21.1
$25.2
$24.4
$24.7
Sci. Policy & Biotech.
$0.9
$1.7
$1.6
$1.8
Science & Technology (S&T)
Registration
$2.1
$2.3
$2.5
$2.5
Reregistration
$2.4
$2.4
$2.5
$2.5
State & Tribal Assistance Grants(STAG)
Implementation Grants
$13.2
$13.0
$12.9
$13.1
Enforcement Grants
$20.3
$19.8
$19.3
$18.9
Total $148.9
$156.8
$153.7
$159.9
Source: Prepared by the Congressional Research Service and based on information from House and Senate
Appropriations Committee Reports, Conference Reports accompanying appropriations, and EPA
Congressional Budget Justifications for FY2002-FY2006.
Pesticide Registration and Reregistration Activities Since the
Enactment of PRIA
EPA uses registration service fees to supplement appropriations to develop
improved registration review processes, hire new staff, and process registration
applications under the deadlines identified in PRIA. The Agency uses the
maintenance fees to supplement appropriations primarily for reregistration and
tolerance review activities. By statute, tolerance reviews and reregistrations for food-
use pesticides are to be completed by August 3, 2006, and all other reregistrations are
to be completed by October 3, 2008.
Registration Activities. Among its initial efforts, EPA reported that
recommendations from several intra-Agency workgroups led to the development of
pesticide registration procedures for front-end processing and screening, waivers and
refunds, funds management, improved intra- and interagency coordination, and
enhancements to the internal registration tracking system. Also during FY2004, EPA
created a “Process Improvement” workgroup under the auspices of the Pesticide
Program Dialogue Committee, an advisory group, to evaluate recommended process
improvements in the registration program. The workgroup comprises representatives
from individual registrant companies, pesticide trade associations, public interest
groups, and Agency staff, and it continues to address process improvement questions.
CRS-16
The Agency reported the completion of 1,512 decisions out of 2,850 registration
submissions subject to PRIA between March 2004 (the effective date for PRIA
implementation) and the end of FY2005. More than 99% of the decisions were
completed within the statutorily mandated decision review times, according to EPA.38
Reregistration/Tolerance Reassessment Activities. EPA has integrated
reregistration and tolerance reassessment processes in an effort to effectively meet
its statutory obligations. When it completes a review of a pesticide for reregistration
or tolerance reassessment, EPA issues one of the following risk management decision
documents: a Reregistration Eligibility Decision (RED), an Interim Reregistration
Eligibility Decision (IRED), or a Tolerance Reassessment Progress and [Interim]
Risk Management Decision (TRED).39
EPA reported40 that by the end of FY2005, it made reregistration decisions for
502 of the original 612 pesticide “cases,”41 including 271 REDs and 231 canceled
cases. EPA also reported the completion of 13 TREDs, 722 tolerance reassessment
decisions, and the reassessment of 167 inert tolerance exemptions. More than 7,800
tolerance reassessments have been completed, and EPA expects that all 9,721
preexisting tolerances will be reassessed by the August 3, 2006 FQPA deadline. Of
the 1,904 tolerances remaining, 528 have been individually assessed through IREDs.
These interim assessments are also to be considered in a cumulative assessment
before the reassessment is considered complete.
Conclusion
Although EPA has made progress in recent years, timely completion of the
statutory registration, reregistration, and tolerance assessment requirements for
pesticides continues to be a concern for Congress, EPA, industry, and public interest
groups. Attempts to defray the increased costs of administering the pesticide
program by modifying existing pesticide fee requirements through regulation and
legislation have not been entirely successful.
Some of the key issues and concerns have been addressed, in part, by the
pesticide fee provisions of Pesticide Registration Improvement Act of 2003 (PRIA),
enacted under the FY2004 Consolidated Appropriations Act (P.L. 108-199). Most
notably, the PRIA provisions requiring specific decision process and schedule
reforms, in conjunction with increasing fee revenues, are expected to lead to more
timely completion of registration applications and reregistration reviews. Reforming
38 EPA, Program Update-Registration, presented to the Pesticide Program Dialogue
Committee (PPDC), October 20, 2005. See [http://www.epa.gov/pesticides/ppdc/], visited
December 5, 2005.
39 For more detailed explanation of these decision documents, see EPA’s website
[http://www.epa.gov/pesticides/reregistration/definitions.htm], visited December 9, 2005.
40 EPA, Reregistration & Tolerance Reassessment FY2005 Review/FY2006 Plan, presented
to the Pesticide Program Dialogue Committee (PPDC), October 20, 2005. See
[http://www.epa.gov/pesticides/ppdc/], visited December 5, 2005.
41 Related pesticide active ingredients are grouped into cases.
CRS-17
the overall process implies accelerated implementation of stricter FQPA standards
and expected associated improvements in the safety of pesticides in the market. It
also suggests the possibility of greater availability of desired products, potentially
safer and more effective, that reach the market sooner. PRIA’s prescriptive detailed
schedule for the service fees is more commensurate with the specific EPA actions
required than previous legislative provisions related to registration and tolerance fees,
which were generally more generic. The schedule is expected to further promote
efficiency in the overall process. The pesticide fee provisions included in PRIA also
are expected to provide continued stability for resource planning purposes; stability
has been lacking in recent years because of annual reauthorizations of maintenance
fees and Administration budget proposals to modify fee authority.
EPA reported progress in developing process improvements and meeting
shortened registration review deadlines during the first shortened fiscal year
implementing PRIA (PRIA became effective March 23, 2004). How efficient the
EPA’s decision-making process becomes depends largely on the Agency’s ability to
continue to establish and effectively implement reforms while maintaining the
protection of human health and the environment required by the statutes. To meet
stricter statutory standards42 and related “sound science” demands, EPA continues to
develop and refine its scientific protocols and guidelines with input from
stakeholders and the scientific community through various public forums.43
However, as past experience shows, this is a complex and time-consuming
undertaking, affected by uncertainties and advances in technology that could enhance
or inhibit the acceleration of the pesticide review process
crsphpgw
42 Stricter standards primarily refer to requirements introduced by FQPA in 1996 to perform
more comprehensive risk assessment of pesticides, considering aggregate exposure,
cumulative effects from pesticides sharing a common mechanism of toxicity, possible
increased susceptibility of vulnerable populations (particularly infants and children), and
possible endocrine or estrogenic effects (see CRS Report RS20043, Pesticide Residue
Regulation: Analysis of Food Quality Protection Act Implementation, by Linda-Jo
Schierow).
43 For examples of EPA advisory workgroups and committees for pesticide science and
procedural issues, access [http://www.epa.gov/pesticides/science/committees.htm], visited
December 9, 2005.