Order Code RL32218
CRS Report for Congress
Received through the CRS Web
Pesticide Registration and Tolerance Fees:
An Overview
Updated May 19, 2006
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 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 2006, EPA released
a report summarizing its second-year progress in implementing the PRIA provisions.
In FY2005, EPA expended $11.2 million of the total $20.3 million new registration
fees collected in FY2005 ($10.9 million) and carried forward from FY2004 ($9.7
million). EPA reported the completion of 1,512 registration decisions out of 2,850
submissions subject to PRIA since its enactment in 2004. The Agency continues to
refine new the procedures for screening pesticide licensing applications and
managing pesticide funds, and for the internal pesticide registration tracking system.
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, the President’s FY2005 and FY2006
budget requests included proposals to further increase pesticide fees, which were
rejected by Congress. The FY2007 President’s budget request includes a similar
proposal. 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 . . . . . . . . . . . . . . . . . . . . . . . . . 7
Statutory Deadline for Reregistration . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Reporting Progress Under PRIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Overview of Pesticide Fee Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
FIFRA and FFDCA Pesticide Fee Collection Authority . . . . . . . . . . . 10
Other Pesticide Fee Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Proposed Pesticide Fee Authority Modifications . . . . . . . . . . . . . . . . . 11
Pesticide Program Fee Revenues and Appropriations . . . . . . . . . . . . . . . . . 13
Revenues from Pesticide Fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Pesticide Program Appropriated Funds . . . . . . . . . . . . . . . . . . . . . . . . 15
Pesticide Registration and Reregistration Activities Since the
Enactment of PRIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Registration Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Reregistration/Tolerance Reassessment Activities . . . . . . . . . . . . . . . 17
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
List of Figures
Figure 1. EPA Pesticide Program Fee Revenues, FY1985-FY2005
(millions of dollars) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
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 (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 2006, EPA reported, as required,2 its FY2005 progress implementing
PRIA. Implementing the Pesticide Registration Improvement Act — Fiscal Year
2005 (hereafter referred to as EPA’s PRIA implementation report) provides
information about the registration process, including the status of its registration and
reregistration activities, as well as EPA’s efforts to improve the processes.
This 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. EPA released its inaugural progress report covering the period January 23, 2004,
through September 30, 2004, in March 2005. The FY2004 and FY2005 reports are available
at [http://www.epa.gov/pesticides/fees/].
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”
are 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
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.” See [http://www.epa.gov/opprd001/
inerts/].
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going forward with rulemaking for collecting pesticide tolerance fees. The
Administration’s FY2007 budget again proposed to modify the fee structure.
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 authority12 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
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).
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$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
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 varies 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 revised fee schedule (70 Federal Register 32327) based on 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
15 Under the provisions of the 1988 amendments to FIFRA (P.L. 100-532), EPA calculates
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 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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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
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 The Agency reported
granting 342 of 479 waivers requested, at a reduction of $11.1 million in registration
service fees.19
To ensure 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.20 EPA appropriations for FY2004 (P.L. 108-
199), FY2005 (P.L. 108-447), and FY2006 (P.L. 109-54), have 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) and by 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.
18 Guidance for registration service fee waivers and reductions is available at
[http://www.epa.gov/pesticides/fees/questions/waivers.htm]; information regarding the fee
reduction formula is available at [http://www.epa.gov/pesticides/fees/fee_reduction.htm].
19 See EPA’s FY2005 PRIA implementation accomplishments report, available at
[http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.htm].
20 Ibid., see Section 33(d) Assessment of Fees.
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Pesticide Registration Process Reforms. In conjunction with the
increased fee revenues, a key provision of the legislation is the requirement for EPA
to identify reforms21 to the Agency’s pesticide registration process with the intent of
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 two PRIA
implementation annual reports, released in March 2005 and March 2006, EPA
described its efforts and accomplishments as of the end of FY2005 (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. EPA released its inaugural report in March 2005 summarizing its first
nine month progress implementing the provisions of the PRIA from January 23,
2004, through September 30, 2004.22 The Agency’s second PRIA progress report,
released in March 2006, Implementing the Pesticide Registration Improvement Act
— Fiscal Year 2005, covers the entire fiscal year.23
According to EPA’s FY2005 progress report, the Agency collected $10.6
million in new “registration service” fees in FY2005 and carried forward $9.7 million
of the $14.7 million collected in FY2004. EPA reported expending $11.2 million of
the $20.3 million available during the fiscal year, and that the remaining balance of
$9.1 million is being carried forward to FY2006. The majority ($7.9 million) of the
fee revenues expended were for increased payroll, reflecting the increase in staff
hired to complete the reviews by the deadlines required by FQPA. EPA reported the
completion of 1,098 decisions subject to PRIA in FY2005, compared with the 208
decisions completed during FY2004. In FY2005, the Agency continued develop
21 Ibid., see Sections 33(e) Reforms to reduce Decision Time Periods, and (f)Decision
Review Time Periods.
22 EPA, “First Annual Report on EPA Actions Implementing the Pesticide Registration
Improvement Act — Fiscal Year 2004,” March 1, 2005, available at [http://www.epa.gov/
pesticides/regulating/fees/pria_annual_report_2004.htm]
23 See [http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.htm]
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new process improvements and to refine those initiated during FY2004. More than
99% of the decisions were completed within the statutorily mandated decision review
times, according to EPA. EPA also reported the expenditure of $750,100 in fees
collected for worker protection in FY2005. Activities included interaction with
stakeholder groups, enhancement of safe practices and pesticide risk recognition
training for workers and health-care providers, and expansion of occupational illness
and injury surveillance. Section 33(c)(3)(b) of PRIA authorizes the use of 1/17 of the
registration fund (not less than $750,000 but not more than $1 million) for enhancing
worker protection scientific and regulatory activities.
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.
Table 1. Timeline of Key Legislation and Regulation Regarding
Pesticide Fees
Year
Legislation/Regulation
Pesticide Fee Authority/Action
1952
Independent Appropriations
Authorizes the head of each agency to
Act of 1952 (IOAA; 31
prescribe regulations establishing a charge
U.S.C. 9701)
for a service or thing of value provided by
the agency.
1954
Federal Food Drug and
Authorizes fees to accompany initial or
Cosmetic Act, amended
modified petitions for establishing tolerances
(FFDCA; P.L. No. 518, 21
under FFDCA section 408 (o).
U.S.C. 346 [a])
1986
EPA Registration Fee
Proposed a schedule of fees to accompany
Regulation: Proposed
pesticide registration and experimental use
(51 Federal Register 42974,
permit applications, citing the authority of
Nov. 26, 1986)
IOAA.
1988
EPA Registration Fee: Final
Establishes fees to accompany pesticide
Regulation (40 CFR 152[u]
registration and experimental use permit
and 40 CFR 172)
applications; authority suspended by the
FIFRA amendments passed later that same
year (1988).
Federal Insecticide,
Authorizes reregistration and expedited
Fungicide and Rodenticide
processing fund: a one-time “reregistration”
Act, amended (FIFRA; P.L.
fee and annual “maintenance” fees through
100-532)
FY1997. Prohibited collection of other fees
(including “registration fees” as defined in
40 CFR 152[u] and 40 CFR 172).
CRS-9
Year
Legislation/Regulation
Pesticide Fee Authority/Action
1996
Food Quality Protection Act
Extends authorization for maintenance fees
(FQPA) (P.L. 104-170):
through FY2001. FFDCA authority (Section
FIFRA and FFDCA, amended
408[m]) 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
Proposed (64 Federal
in existing tolerance fees and new “tolerance
Register 31039-31050, June
reassessment” fees, including fee for
9, 1999)
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
(P.L. 106-377)
fee rule based on EPA’s 1999 proposal.
2000
FY2001 EPA Appropriations
Continues prohibition on promulgation of a
(P.L. 106-774)
final tolerance fee rule as proposed in 1999.
2001
FY2002 EPA Appropriations
Continues the prohibition on promulgation
(P.L. 107-73)
of a final 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.
2002
Farm Security Act
Senate-proposed pesticide fee authorities
(P.L. 107-171)
considered 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
2003
(P.L. 108-10) and FY2004
fee rule based on the 1999 proposal.
Continuing Resolution (P.L.
Continued prohibition of the collection of
108- 135; through Jan. 31,
registration fees as codified in 1988.
2004)
Maintenance fees reauthorized; maximum
aggregate levels increased.
S. 1664 and H.R. 3188,
Would have authorized new a registration
proposed; the basis for PRIA
service fee, reauthorized maintenance fees,
provisions later included in
required pesticide regulation process
the FY2004 Consolidated
reforms, and prohibited collection of
Appropriations Bill (P.L.
tolerance fees.
108-199)
2004
FY2004 Consolidated
Authorizes new registration “service” fee,
Appropriations Bill (P.L.
reauthorizes maintenance fees, requires
108-199; Division G, Title
pesticide regulation process reforms, and
V), enacted January 23, 2004
prohibits the collection of tolerance fees.
CRS-10
Year
Legislation/Regulation
Pesticide Fee Authority/Action
FY2005 Consolidated
Provides continued authorization for the
Appropriations Act FY2005
collection of pesticide fees pursuant to P.L.
(P.L. 108-447), enacted
108-199.
December 8, 2004
2005
FY2005 supplemental
Bans EPA from going forward with
appropriations for military
rulemaking for collecting pesticide tolerance
funding (P.L. 109-13, Sec.
fees as prohibited by PRIA.
6033) enacted May 11, 2005
2006
Interior, Environment, and
Provides continued authorization for the
Related Agencies
collection of pesticide fees pursuant to P.L.
Appropriationsa Act for
108-199.
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
FFDCA.24 At the time, Section 408(o)25 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,” to 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
24 Pesticide Residue Amendment of 1954, P.L. No. 518, 21 U.S.C. 346(a).
25 This authority currently resides in FFDCA Section 408(m) (1996 FQPA).
CRS-11
tolerances and reassessing old tolerances.26 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.27
Other Pesticide Fee Authority. In May 1988, prior to the 1988 FIFRA
amendments, EPA had promulgated a final pesticide registration fee regulation,28
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,29 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
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.30
Proposed Pesticide Fee Authority Modifications. In June 1999, EPA
proposed a rule restructuring tolerance fees31 in an effort to cover the cost of
establishing initial tolerances and tolerance reassessments, including tolerance
activities for “other” ingredients (namely, inert ingredients32). 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
26 See CRS Report RS20043, Pesticide Residue Regulation: Analysis of Food Quality
Protection Act Implementation, by Linda-Jo Schierow.
27 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 to $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).
28 40 CFR 152(u) and 40 CFR 172.
29 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.
30 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 Jan. 31, 2004) contained similar prohibitive language.
31 64 Federal Register 31039-31050, June 9, 1999.
32 The 1996 FQPA clarified that “inert” ingredients are covered by the definition of a
pesticide chemical under FFDCA (section 201[q][1]).
CRS-12
EPA’s justification for the tenfold increase in fees, the imposition of fees
retroactively, and the potential effects of imposing fees for inert ingredients.33
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 FY2004,34 have been prohibited each year by Congress in
appropriations acts.35 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, FY2006,
and FY2007 budget requests for EPA. The 108th Congress rejected the President’s
FY2005 budget proposal to reinstate pesticide fees in the conference report on the
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, included $46.0 million in the form of
“anticipated” revenues (offsetting receipts) to be derived from changes to fees for
pesticide registrations.36 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
33 EPA Docket # OPPT-301151 and OPPT-301151B.
34 See EPA Budget Proposals and Congressional Justifications for FY2001-FY2005 on
EPA’s website ([http://www.epa.gov/ocfo/budget/index.htm]).
35 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.
36 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].
CRS-13
proposing such actions in conflict with current authority (H.Rept. 109-80, p. 105-
106).37 The President’s FY2007 budget submitted to Congress in February 2006
proposed modifications to the current pesticide fees structure to collect $56 million.38
At the time of the update of this report, Congress was deliberating EPA’s FY2007
appropriations.
Pesticide Program Fee Revenues and Appropriations
The historical appropriated funding and fee revenues for the pesticide program
activities provide 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
FY1998), reregistration fees, maintenance fees, and registration service fees collected
during 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.
37 Executive Office of the President, Office of Management and Budget, Major Savings and
Reforms in the President’s 2006 Budget, available at [http://www.whitehouse.gov/
omb/budget/fy2007/pdf/savings.pdf]
38 Executive Office of the President, Office of Management and Budget, Major Savings and
Reforms in the President’s 2006 Budget, pp. 222-224, at [http://www.whitehouse.gov/
omb/budget/fy2006]. See also U.S. Environmental Protection Agency FY2006 Justification
of Appropriation Estimates for the Committee on Appropriations, available at
[http://www.epa.gov/ocfo/budget/].
CRS-14
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
have been adjusted over time, based on an inflation calculation defined in statute.39
For the 20 years prior to the enactment of PRIA, annual tolerance fees collected by
EPA averaged about $1.8 million.
39 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).
CRS-15
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, resulting in 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 to $21.5 million in FY2003 (P.L. 108-7) and FY2004 (continuing
resolution P.L. 108-135,40 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. Pesticide fee revenues are
supplemental to appropriated funds provided for EPA’s pesticide program activities.
As in recent previous fiscal years, FY2006-appropriated funding (P.L. 109-54) for
EPA’s pesticide program activities was allocated within three of the eight EPA
appropriations accounts: Science and Technology (S&T), Environmental Programs
and Management (EPM), and State and Tribal Assistance Grants (STAG). For the
three accounts combined, Congress provided $161.8 million for FY2006 for EPA’s
pesticide program activities, an increase relative to each of the three previous fiscal
years. Table 2 shows enacted appropriations for FY2003 through FY2006, and
proposed for FY2007, within the three appropriations accounts for the five EPA
pesticide program activity areas as presented in Appropriations Committee reports
and EPA fiscal year congressional budget justifications.41
40 See also P.L. 108-84, Sept. 30, 2003, and H.J.Res. 69 Section 118, 108th Congress, first
session (2003).
41 See [http://www.epa.gov/ocfo/budget/].
CRS-16
Table 2. EPA Appropriations for Pesticide Program Activities
FY2003-FY2006 Enacted
(million dollars)
Pesticide Program
FY2003
FY2004
FY2005
FY2006
FY2007 FY2007
Activities by EPA
Enacted
Enacted
Enacted
Enacted
Budget
H.R.
Appropriations
P.L.
P.L. 108-
P.L. 108-
P.L. 109- Request 5386
Account
108-7
199
447
54
Environmental Program Management(EPM)
Registration
$40.4
$40.8
$39.2
$41.6
$39.8
$41.8
Reregistration
$48.5
$51.7
$51.3
$57.5
$51.8
$54.3
Field Programs
$21.1
$25.2
$24.4
$24.5
$24.9
$24.9
Sci. Policy &
$0.9
$1.7
$1.6
$1.7
$1.8
$1.8
Biotech.
Science & Technology (S&T)
Registration
$2.1
$2.3
$2.5
$2.5
$2.8
$2.8
Reregistration
$2.4
$2.4
$2.5
$2.5
$2.8
$2.8
State & Tribal Assistance Grants(STAG)
Implementation
$13.2
$13.0
$12.9
$12.9
$13.0
$13.0
Grants
Enforcement Grants
$20.3
$19.8
$19.3
$18.6
$18.7
$18.7
Total $148.9
$156.8
$153.7
$161.8
$155.6
$160.1
Sources: Prepared by the Congressional Research Service based on information from House and
Senate Appropriations Committee Reports, Conference Reports accompanying appropriations, EPA
Congressional Budget Justifications for FY2002-FY2006, and H.R. 5386, as reported by the House
Appropriations Committee (H.Rept.109-465) on May 15, 2006.
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. As discussed earlier in this report, EPA reported the
completion of 1,316 decisions subject to PRIA between March 2004 (the effective
date for PRIA implementation) and the end of FY2005. In addition, during the past
two fiscal years (FY2004 and FY2005), EPA approved registrations for 50 new
active ingredients, including 22 conventional (7 conventional reduced risk), 24
CRS-17
biopesticides, and 4 antimicrobials. During that same period, the Agency approved
more than 960 new uses of previously registered active ingredients.42
Among its initial efforts to enhance the registration process, 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. EPA also 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, which was further
expanded in FY2005, comprises representatives from individual registrant
companies, pesticide trade associations, public interest groups, and Agency staff, and
it continues to address process improvement questions.
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).43
EPA reported44 that by the end of FY2005, it made reregistration decisions for
502 of the original 612 pesticide “cases,”45 including 271 REDs and 231 canceled
cases. The Agency must complete 112 more REDs to meet complete reregistration
by the end of FY2008. 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.
42 The number of new registrations and new uses were compiled with data from EPA
Program Update-Registration, presented to the Pesticide Program Dialogue Committee
(PPDC) for FY2004 on October 21, 2004, and for FY2005 on October 20, 2005. See
[http://www.epa.gov/pesticides/ppdc/].
43 For more detailed explanation of these decision documents, see [http://www.epa.gov/
pesticides/reregistration/definitions.htm].
44 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/].
45 Related pesticide active ingredients are grouped into cases.
CRS-18
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
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 and continued to make refinements in FY2005. (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 standards46 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.47 However, as past experience shows, this is a
complex and time-consuming undertaking, affected by uncertainties and advances in
46 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.)
47 Examples of EPA advisory workgroups and committees for pesticide science and
procedural issues are available at [http://www.epa.gov/pesticides/science/committees.htm].
CRS-19
technology that could enhance or inhibit the acceleration of the pesticide review
process