Document ID: EPA-HQ-OPP-2006-0636-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-04-26T04:00Z

Implementing the Pesticide Registration Improvement Act -- Fiscal Year
2005 

Second annual report. Report release date: March 1, 2006.

Contents:

   HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "1#1"  Early Implementation Efforts 

   HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "2#2"  Financial Overview 

   HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "3#3"  Progress in Meeting Decision Times 

   HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "4#4"  Process Improvements in the Registration Program  

   HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "5#5"  Progress in Meeting Tolerance Reassessment and Food Use
Reregistration Timelines  

   HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "6#6"  Other Considerations  

   HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "7#7"  Appendix A: Decision Review Types for Actions Completed
During FY2004 

The Consolidated Appropriations Act of 2004 established a new system for
registering pesticides, called the Pesticide Registration Improvement
Act, or PRIA. PRIA, the new section 33 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA),, creates a registration service
fee system for applications for specified pesticide registration,
amended registration, and associated tolerance actions, which set
maximum residue levels for food and feed. Under PRIA, fees are charged
for covered applications received on or after March 23, 2004, and for
certain pending applications received before that date. EPA is required
to make a determination on the application within the decision times
specified. The fee system is authorized until September 30, 2010,
although the decision times under the system do not apply to
applications received after September 30, 2008. 

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.
The report must include several elements, including a review of the
progress made in carrying out the Agency’s obligations under the Act,
a description of the staffing and resources associated with the review
of and decision-making on applications, and a review of its progress in
meeting the reregistration and tolerance reassessment timeline
requirements. This second annual report covers Fiscal Year 2005 -
October 1, 2004, through September 30, 2005. 

Early Implementation Efforts and FY 2005 Enhancements 

The   HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2004.h
tm"  first annual report  released in March 2005, describes steps the
Agency undertook to implement PRIA during its first nine months. These
included front end processing and screening, waivers, funds management,
and communications. In Fiscal Year 2005, the Agency’s Office of
Pesticide Programs (OPP) further refined its procedures and processes in
these areas as described below.

Front-End Processing and Screening Procedures

To facilitate the implementation of PRIA, the Agency established
front-end screening procedures for new pesticide applications in FY
2004. An intra-agency workgroup interpreted the   HYPERLINK
"http://www.epa.gov/pesticides/fees/categories/index.htm"  90 PRIA
registration categories  to help both applicants and the Agency
consistently place each application in the appropriate PRIA category.
These PRIA registration categories reflect the types of applications
that the Agency may receive and for which Congress has established a fee
and a time frame. The time frame, or decision review time, is the amount
of time the Agency is expected to take to review the application and
reach a regulatory decision. The Agency intends to update these
interpretations in FY 2006 based on its experience in FY05. 

Teams of EPA experts from the three registering divisions (conventional
chemical pesticides, biopesticides, and antimicrobial) pesticides screen
all incoming applications to determine whether they are subject to PRIA,
and to assign the application to a PRIA category (if appropriate). By
adding a chemist and toxicologist to the expert team for conventional
pesticides in 2005, the Agency improved the efficiency of its front-end
processing screens. The experts do a cursory screen of the submission
for completeness, thus saving both the registrant and the Agency
valuable time. The Agency has also conducted an analysis of the
frequency of incomplete conventional pesticide applications submitted
under PRIA and is working on processes that will result in improved
applications for all types of pesticides. Typically within 48-72 hours
of receipt of an application, the registrant is sent an invoice
requesting payment of the appropriate PRIA registration service fee.

The Agency’s internal tracking system, known as the Office of
Pesticide Programs Information Network (OPPIN), was modified to track
extensions in due dates and withdrawals resulting from an unpaid PRIA
fee. Reports enable Agency managers to monitor the workload in their
units. Reports enable Agency managers to monitor the workload in their
units. The Agency also enhanced OPPIN to notify registrants
electronically when the Agency has received their payments. 

The Agency enhanced its existing data management contract for the
initial data screen in FY 2004 to reduce study processing time to 10
days, thus ensuring that complete data packages are ready to enter the
review process at the beginning of the decision review period if the
applicant has correctly formatted the data submission. During FY 2005,
the average study processing time for the front end screen was 4.6 days.

Funds Management and Utilization

Section 33(c) of PRIA established the Pesticide Registration Fund.
Congress established this fund in the Treasury of the United States to
carry out the provisions of PRIA. All registration service fees received
by EPA are deposited in this fund, and expenditures from the fund can
cover the costs associated with the review and decision-making for
applications for which registration service fees have been paid. In FY
2004, the Agency worked with the Mellon Bank to establish the fund and
create billing procedures and to coordinate communications on fee
receipts between the bank and the Agency. Communications were
particularly critical as fee receipt triggers the start of the PRIA
review period. The Agency was informed of the receipt of a payment
within an average of 7.2 days of receipt by the Mellon Bank, and since
May 17, 2005, the Agency automatically sends an acknowledgment of
payment to those applicants with an e-mail address on file. 

In July 2005, EPA began notifying applicants when a payment is 45 days
overdue for all PRIA fee categories except Fast Track applications
(because of the short time frames for these actions). The notification
provides the applicant 75 days to forward payment before the application
is administratively withdrawn. The Agency sent 55 such letters,
resulting in 24 withdrawn applications, 26 payments or fee waivers, and
5 that are currently being resolved. 

Waivers and Fee Reductions

Section 33(b)(7) of PRIA authorizes the Agency to reduce or waive the
registration service fee under certain specified situations. The Agency
in FY 2004 developed and posted on the internet   HYPERLINK
"http://www.epa.gov/pesticides/fees/questions/waivers.htm"  guidance on
how to apply for waivers of the registration service fee . The Agency
reviewed 429 applications and reduced the average number of days to
grant a fee waiver from 48 to 24 days during FY 2005. The Agency also
established   HYPERLINK
"http://www.epa.gov/pesticides/fees/fee_reduction.htm"  formulas for
reducing certain registration service fees  based on work completed by
the Agency prior to the effective date of PRIA. Section 33(b)(8)(C)
authorizes EPA to issue discretionary refunds, including instances where
the Agency had completed portions of the review of an application before
the PRIA effective date. For fees required for pending new active
ingredients and for applications where the registrant has offered to pay
the registration service fee voluntarily, the Agency applied this refund
provision as a credit toward the application registration service fee.
During FY 2005, the Agency reduced registration service fees by $1.6
million based on work completed by the Agency on pending applications
prior to the PRIA effective date. The amount in FY 2004 was $3.7
million. 

Communications and Outreach

As required by the statute, on March 17, 2004 , the Agency published the
schedule of covered applications and registration service fees. Under
Section 33(b)(6), these fees increased by 5 percent on applications
received on or after October 1, 2005 . The new fee schedule was
announced in the Federal Register of June 2, 2005. (  HYPERLINK
"http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gp
o.gov/2005/pdf/05-10998.pdf"  Pesticides; Revised Fee Schedule for
registration Applications  (PDF, 9 p., 85 KB,   HYPERLINK
"http://www.epa.gov/epahome/pdf.html"  About PDF )). In September 2005,
the Agency sent an electronic reminder of this fee increase to over
4,000 individuals and organizations as an “OPP Update”. 

In 2005, the Agency conducted meetings and a number of other outreach
efforts on PRIA implementation. Agency staff discussed PRIA
implementation during the Chemical Producers and Distributors
Association Registration Workshop, with State and EPA Regional staff at
the Pesticide Regulatory Education Program, and with the Armed Forces
Pest Management Board. During the annual meeting of the Consumer
Specialty Products Association, EPA and the Natural Resources Defense
Council discussed PRIA implementation, compliance with Pesticide
Registration Notice 86-5 (standards for registration application
submissions), and fee waivers. EPA provided updates on the status of
PRIA actions received and summary statistics during meetings of the
Agency’s Federal Advisory Committee, the Pesticide Program Dialogue
Committee (PPDC). EPA also has quarterly meetings with the Biopesticide
Industry Alliance to discuss PRIA and other common issues and with the
United State Department of Agriculture IR-4 program. The USDA IR-4
program is working with a number of small companies with new
biopesticide active ingredients. During the 2005 Annual Antimicrobial
Workshop, EPA provided additional clarification to the antimicrobial
industry on which actions were or were not covered by PRIA. 

In FY 2004, the Agency established a website dedicated to   HYPERLINK
"http://www.epa.gov/pesticides/fees"  PRIA implementation . Through this
website, the public can submit questions regarding PRIA implementation.
Questions are typically answered within 24 hours. Questions are also
addressed by registration Ombudsmen. The Ombudsman also help applicants
with issues related to the registration process and completing
application forms. 

  HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "pagecontents#pagecontents"  Top of Page 

Financial Overview

During Fiscal Year 2005, the Agency received $10.6 million in new
registration service fees (and carried a balance of $9.7 million forward
from FY 2004). From this total of $20.3 million, the Agency spent
approximately $11.2 million, carrying the remaining balance of $9.1
million forward to FY 2006. 

Agency's FY 2004 and FY 2005 Expenditures from the Pesticide
Registration Fund 

For 	FY 2004 Expenditures (figures are in thousands)	FY 2005
Expenditures (000) 

Payroll 	$2,535.3 	$7,898.2 

Contracts 	$1,591.3 	$2,228.8 

Worker Protection 	$430 	$750.1 

Other Expenses 	$455.8 	$274.3 

Total 	$5,012.5 	$11,151.4 

PRIA became effective March 23, 2004 , and consequently FY 2004 was only
a half year while FY 2005 was the first full fiscal year under PRIA. As
was the case in FY 2004, the majority of expenditures from the Pesticide
Registration Fund in FY 2005 were spent on payroll costs and to expand
data review output through contracts. In order to meet PRIA registration
review time frames, payroll expenditures increased more than threefold
in FY 2005 to $7.9 million (compared with $2.5 million in FY 2004). A
major factor in this increase was that PRIA was in effect for only six
months of FY 2004. Expenditures on contracts also increased, but less
dramatically than payroll (up to approximately $2.2 million in FY 2005
compared with $1.6 million in FY 2004). Included in the payroll and
contract expenses are $472.9K ($430.0K in contracts and $42.9K in
payroll) to accelerate the review of new inert ingredients. The amount
spent on worker protection was $750,106 ($728.8K for contracts/grants
and $21.3K on printing). T he Agency continued to invest in upgrading
its information management system (the Office of Pesticide Programs
Information Network) to track compliance with the PRIA review time
frames and to meet reporting requirements. Other funds went primarily to
pay for Federal Register printing costs associated with PRIA
registrations. 

Waivers of Registration Service Fees

In response to requests for fee waivers and fee reductions, as
authorized by PRIA, the Agency waived $11.1 million in registration
service fees. The Agency reviewed 429 waiver requests, granting 342 and
denying 64. The time for the Agency to reach a decision to grant a
waiver declined to an average of 24 days at the end of FY 2005, while
the time to deny a waiver request was within 50 to 54 days. The time
required to deny a waiver reflects the time the Agency took to obtain
missing information in an attempt to be able to grant the fee waiver.
The table below summarizes the outcome of the 100 percent and 50 percent
waiver requests received in FY 2005. In addition to these waivers, the
Agency processed a number of fee waivers requested by the USDA IR-4
program.

Small Business Waiver Requests -- FY 2005 

Waiver	Submitted	Granted	Denied	Withdrawn

100 % 	248 	197 	45 	16 

50 % 	124 	104 	14 	6 

Total 	372 	301 	59 	22 

The average number of days EPA took to grant or deny a fee waiver in FY
2005 is summarized in the table and illustrated in the graph below. In
general, processing times have decreased with a slight increase in the
second quarter of FY 2005 when applicants were required to submit
complete and updated financial information.

Average Number of Days to Process Fee Waivers in a Quarter, 2005 

Quarter	To Grant 	To Deny 

1st Q	38	50

2nd Q	48	47

3rd Q 	22	51

4th Q 	24	54

 

 

Worker Protection

Section 33(c)(3)(b), EPA is authorized to use 1/17 of the amount of the
Fund (but not more than $1 million and not less than $750,000 for any
fiscal year) to enhance current scientific and regulatory activities
related to worker protection. The Agency worked closely with worker
safety stakeholders through the Agency’s Federal Advisory Committee
the Pesticide Program Dialogue Committee, to determine which activities
to enhance with PRIA funds. Based on the advice of the PPDC, the Agency
decided to develop enhancements within focus areas characterized as:
Prevention - Safety Training; Response - Poisoning Recognition; Sound
Decision Data; and, Inform - Risk Management. Within these areas, PRIA
funds were used for the following activities in FY 2005: 

National Agricultural Workers Survey - The Department of Labor annually
surveys farm workers to collect demographic information. This is the
only source of national information on farm worker employment, health
and living conditions, and demographic data. PRIA funds have been
provided for special focus reports which will be used to enhance program
measures, risk management, risk mitigation, communication, outreach, and
training. 

National Institute of Occupational Safety and Health Sentinel Event
Notification System for Occupational Risk (SENSOR) Program - PRIA Funds
were used to increase the number of states in the SENSOR program and to
expand occupational illness and injury surveillance capacity within
state health departments in areas of the country with sizable
agricultural worker populations. 

The Association of Farmworker Opportunity Programs / AmeriCorps
Pesticide Worker Safety Training Program - PRIA Funds were used to
increase the number of trainers carrying out education programs to
reduce the risks of pesticide use. The program is established at 22
sites in 13 states working with AmeriCorps members to educate
farmworkers in rural areas about worker protection measures and safe
pesticide practices. 

Pesticides and National Strategies for Health Care Providers Initiative
- PRIA Funds were used to enhance the national initiative to improve the
training of health care providers in the recognition, diagnosis,
treatment, and prevention of pesticide poisoning among those who work
with pesticides. The University of Washington Pacific-Northwest
Agricultural Safety and Health Center will work with decision-makers and
faculty at academic institutions and professional associations or
organizations to create institutional change in the educational settings
for health care providers. 

The Migrant Clinicians Network - will work directly with health care
providers to change the practice of primary care so that
pesticide-related health conditions are recognized, effectively managed,
and prevented in practice settings. 

The National Pesticide Information Center - PRIA Funds were used to
ensure the availability of Spanish speaking staff during the times when
Spanish speaking pesticide workers were likely to call for information
or reference to clinical services. 

  HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "pagecontents#pagecontents"  Top of Page 

Progress in Meeting Decision Times

Number of PRIA Actions Completed in FY 2005

The Agency completed 1098 decisions subject to PRIA during the fiscal
year, a substantial increase over FY 2004’s 208. EPA completed 99.8
percent of these decisions met their PRIA due date. The chart below
summarizes the number of decisions completed by PRIA category. An
application can have more than one decision. The number of decisions
depends on the number of product registrations in an application. For
instance, in FY 2005, one new antimicrobial active ingredient (A2) was
registered that required two decisions. Information on the number of
active ingredients and uses registered during a year can be found in the
Office of Pesticide Program’s   HYPERLINK
"http://www.epa.gov/oppfead1/annual/"  Annual Reports . Generally each
application categorized as a Fast Track, Non-Fast Track New Product, and
Non-Fast Track Amendment is a single decision. 

The average decision time for each PRIA category with completed
decisions is shown in days - the number of days it took the Agency to
complete a decision once payment was made or a fee waiver was granted.
The time frames mandated under PRIA decreased for some categories of
decisions in FY 2005 from FY 2004. A decision’s time frame is based on
the fiscal year in which the application or decision was received. Even
though a fee was paid or a fee waiver was granted in FY 2005, an action
received in FY 2004 had a FY 2004 PRIA timeframe with the beginning of
the timeframe in FY 2005. The average decision time in the table below
does not take into consideration this change in time frame and is an
average over the whole Fiscal Year. 

While many new active ingredient applications and new use applications
appear to have been completed in substantially less time than the
decision time frame provided under PRIA, many of these actions were
submitted prior to March 23, 2004 , PRIA’s effective date and
benefited from work completed before the effective date. Decision times
for these actions, such as R1 to R29, are expected to be greater in
future years as more recently received decisions are completed. 

Among the FY 2005 completions, the PRIA due dates for 69 (6 percent)
were extended or negotiated by agreement between the Agency and the
applicant. This generally occurred because of missing or deficient data
or information.

Key to the Table 

R – Conventional Pesticides	EUP – Experimental Use Permit

A – Antimicrobial Pesticides	SCLP - Straight Chain Lepidopteran
Pheromones

B – Biopesticides 	PIP - Plant-Incorporated Protectants

 	SAP – FIFRA Scientific Advisory Panel 

Progress in Meeting Decision Times

  PRIA Category 	Description of Category 

 

  is needed to view this file.)

  HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "pagecontents#pagecontents"  Top of Page 

Number of PRIA Applications Pending at the End of FY 2005.

The following table summarizes the number of pending registration
applications (counted as decisions) in each of the PRIA categories. As
of September 30, 2005 , 1178 applications subject to PRIA were pending
in the Agency’s registration queue. The number pending at the end of
FY 2004 are shown for comparison.

Key to the Table

R – Conventional Pesticides	EUP – Experimental Use Permit

A – Antimicrobial Pesticides	SCLP - Straight Chain Lepidopteran
Pheromones

B – Biopesticides 	PIP - Plant-Incorporated Protectants

 	SAP – FIFRA Scientific Advisory Panel 

Pending Inert Ingredients at the End of FY 2004

PRIA section 33(k)(2)(A)(ii) also requires EPA to provide the number of
inert ingredients pending review by the Agency. As of September 30,
2005, the Agency had 32 petitions for new inert ingredients pending
review. 

  HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "pagecontents#pagecontents"  Top of Page 

Process Improvements in the Registration Program

Section 33(e) of PRIA directs EPA to identify and evaluate reforms to
the pesticide registration process with the goal of reducing decision
review times for pesticide registration applications. The Agency has
made considerable progress during the fiscal year in improving its
operations. It has undertaken a number of steps, both internal and
external, to explore, develop, and implement improvements in the
registration process.

In identifying process improvements, the Agency will not compromise the
scientific quality of its assessments as a means toward reducing
decision times. The Agency believes that, in terms of receiving
recommendations for process improvements, the best means of gathering
together suggested improvement areas was through the Federal Advisory
Committee Act (FACA) process. 

Pesticide Program Dialogue Committee PRIA Process Improvement Workgroup

The PRIA Process Improvement Workgroup was created in FY 2004 under the
auspices of the Agency’s Federal Advisory Committee, the Pesticide
Program Dialogue Committee, to evaluate process improvements in the
registration program. The workgroup is composed of members of registrant
companies, pesticide trade associations, public interest groups, and
Agency staff. Meetings are open to the public and are held approximately
3 or 4 times a year. Reports of the October 12, 2004, January 25, 2005,
and September 14, 2005,   HYPERLINK
"http://www.epa.gov/oppfead1/cb/ppdc/pria/index.html"  PPDC PRIA Process
Improvement Workgroup meetings  are posted on the internet. 

Industry stakeholders identified many areas for improvement in the
registration process, including labeling consistency, communication of
schedules, and the involvement of the registrants in the decision-making
process. Many of the process improvements proposed by the Agency
addressed those issues. The Agency continues to work with all
stakeholders to evaluate these and other potential improvements to the
registration process. 

Labeling Committee

Both stakeholders and the Agency recognized that labeling issues should
be addressed. The Agency formed a cross-program Labeling Committee to
address broad labeling issues and to oversee revisions to the  
HYPERLINK "http://www.epa.gov/oppfead1/labeling/lrm/"  Label Review
Manual . A subgroup, the Label Review Manual Team, was formed to revise
and continually update the Label Review Manual. The Committee drafted an
internal Standard Operating Procedure, prioritized stakeholder issues,
obtained concurrence on issues to be addressed, developed a web site for
labeling issues, and formulated options on priority issues. 

  HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "pagecontents#pagecontents"  Top of Page 

Process Improvements Implemented within the Pesticide Registration
Program

The Agency implemented a number of process improvements to monitor
workload and assure that PRIA due dates are met. The Agency’s
Biopesticide and Pollution Prevention Division analyzed its registration
process and divided the work into five phases (screening, publication in
the Federal Register where appropriate, preliminary review, secondary
review and risk assessment, and document development). For each B fee
category (biopesticides B58 to B90), timelines were established for each
phase to better manage the workflow and provide a fair and consistent
mechanism for calculating the additional time needed if a deficiency had
to be addressed. The Agency created a new team to expedite the secondary
review of simple actions where no deficiencies were identified in the
primary review. This has reduced the time to complete these actions .
EPA encourages biopesticide registration applicants to participate in
presubmission conferences and provides guidance throughout the
application process to increase the number of complete applications. 

The Agency’s analysis of its biopesticide workload is one example of
numerous activities EPA undertook to reduce the amount of time taken to
complete decisions. Workload and compliance with PRIA due dates are
monitored in numerous internal Agency meetings. Throughout the pesticide
registration program, weekly meetings are held to review the status of
pending decisions, due date extensions, and refunds; to identify
potential issues and target their resolution; and to coordinate
schedules with science support organizations. Justifications for
extending or negotiating a PRIA due date and for a PRIA determination
not to grant a registration are reviewed and decisions are made at
senior management levels. On a bi-monthly basis, progress in meeting
PRIA due dates and the pending workload requiring action in the short
term are evaluated across all involved organizations and periodically
shared with stakeholder groups. 

With decreasing time frames, efforts have been increased to monitor the
flow of data and documents and to identify missing or deficient data or
information. To manage the flow of PRIA applications, the Agency
established centralized locations for and electronic documentation of
receipt and delivery of risk assessments. It formalized a standard
process to screen new chemical data packages for completeness and to
identify critical scientific flaws in environmental and ecological data.
Incoming data packages are logged in, prepared for contractor review,
and shipped to the contractor within a week. Contractors return a draft
report within 10 working days. EPA staff complete a final report of
deficiencies (if any). The target date for this science screen is 30
days from receipt of the data package by the risk assessor. 

Registration Program Workplans

The multi-year   HYPERLINK "http://www.epa.gov/opprd001/workplan/" 
workplan for new conventional chemical actions  under PRIA was posted in
September 2005, and a similar workplan for new uses of conventional
pesticides was posted in December 2005. This workplan is updated
quarterly to reflect new actions received under PRIA, actions completed,
and changes to schedules. For a majority of the new chemical and new use
actions listed, the time frame in which the Agency expects to complete
its registration decision is shorter than that specified by PRIA. One
efficiency improvement came when the Agency identified requests for new
uses submitted by USDA’s IR-4 program that were also being requested
by registrants. Those requests have been merged into one risk
assessment. Additional economies and time-savings were achieved where
possible by folding new use assessments into assessments currently being
conducted for reregistrations and tolerance reassessment. 

The FY 2006   HYPERLINK
"http://www.epa.gov/oppbppd1/biopesticides/index.htm"  workplan for new
biopesticide active ingredients  has also been posted. This workplan is
updated at least once a quarter to reflect completed actions and changes
to the schedule. The workplan for new antimicrobials will be posted by
April 3, 2006 . 

Formation of Inert Ingredients Assessment Branch

The Agency has created a new Inert Ingredients Assessment Branch in the
Office of Pesticide Programs to provide a single unit for all scientific
and regulatory activities related to inert ingredients (pesticide
ingredients not intended to be pesticidally active, such as
surfactants). Inert ingredients in products to be used on food crops
must have a tolerance (maximum residue level) or an exemption from
tolerance. The new branch is developing processes to reduce decision
times for new inert ingredient tolerance petitions. They are also
developing a website that will show the status of all the inert
ingredient tolerance exemptions that have been reassessed, along with
the reassessment reviews.The petition backlog has been reduced
significantly during FY 2005 and, by using contractor resources in
addition to EPA staff, they anticipate further reductions or elimination
of the backlog in FY 2006. The tolerance exemption reassessment effort
has been streamlined, resulting in a greater number of completed
reassessments in FY 2005 compared to past years. The remaining tolerance
exemptions will be reassessed by the August 3, 2006 , deadline. 

  HYPERLINK
"http://www.epa.gov/pesticides/regulating/fees/pria_annual_report_2005.h
tm" \l "pagecontents#pagecontents"  Top of Page 

Scoping Meetings

Scoping is the process of examining and often re-examining an action to
determine what specific work is required to complete the action. Another
aspect of scoping is determining how the work can be completed in the
most efficient manner possible and defining a schedule for the action
based on this determination. The Agency’s scientific organizations
have also begun scoping exercises, such as problem formulation and risk
tiering, to evaluate new registration submissions. The division of the
Office of Pesticide Programs that is responsible for benefits
assessments participates in chemical team meetings along with the other
scientific organizations to further a team approach to review and
assessment. This additional coordination permits them to plan more
effectively for generating Screening Level Usage Analyses for specific
chemicals and ultimately results in more timely decisions under PRIA. 

Biopesticide Registrant Assistance

The Biopesticides and Pollution Prevention Division created an email
service in FY 2004, known as   HYPERLINK
"mailto:bppdconsistency@epa.gov"  bppdconsistency@epa.gov , to respond
to generic questions about biopesticide registration processes. The
Division’s regulatory staff meet on a regular basis to discuss
questions raised through this service and provide an answer usually
within two to three weeks. The   HYPERLINK
"http://www.epa.gov/pesticides/biopesticides/regtools/reg_inconsist.htm"
\l "Issue_01"  registrant questions and EPA’s responses  are posted on
the web. To date, the Agency has posted five such questions and
responses. 

Science Review Improvements

For conducting pesticide environmental risk assessments, the Agency
created improvements to its models called, "enter once, use many times".
Data, such as environmental chemistry data, are entered into a model
once and then used many times while other parameters are modified to
view the effects or impacts of alternative exposure scenarios. Level 2
terrestrial and aquatic risk models have been modified to complete a
risk assessment within one modeling environment. Other tools are being
explored to allow an assessment of risks within the framework of a
single model by drawing on outputs of current exposure models and
extracting effects endpoints within a single modeling environment. This
will result in more efficient use of existing databases. : 

In FY 2004, in response to an industry request, the Agency established a
waiver decision process for certain studies used for hazard
identification. Waivers may be granted if evidence is submitted showing
that the additional test is not needed to identify the nature of the
hazard. Of 46 repeat dose inhalation toxicity studies originally
requested, 35 waivers have been granted, 9 denied, and 2 are still being
reviewed. 

  HYPERLINK
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Progress in Meeting Tolerance Reassessment and Food Use Reregistration
Timelines

FY 2005 Accomplishments

During Fiscal Year 2005, the Agency made significant progress in
completing risk assessments and risk management decisions for pesticide
reregistration. The Agency completed 28 Reregistration Eligibility
Decisions (REDs) and issued tolerance reassessment eligibility decisions
(TREDs) for 13 active ingredients. These decisions resulted in the
completion of 724 tolerance reassessments 

Status of Reregistration

Through the end of FY2005, the Agency has completed 271 REDs and must
issue 112 more REDs to complete reregistration by the end of FY 2008.
EPA’s goal is to complete 46 reregistration eligibility decisions
(REDs) and finalize 23 Interim REDs (IREDs) during FY 2006 for
pesticides with associated tolerances and to complete a total of 43 REDs
in FY 2007 and FY 2008 for pesticides with no food uses or tolerances.
This will satisfy PRIA requirements and support the Agency’s tolerance
reassessment and reregistration goals.   HYPERLINK
"http://www.epa.gov/pesticides/reregistration/candidates.htm"  EPA’s
schedule for completing these decisions  can be found on the Agency’s
website. 

Status of Tolerance Reassessment

Through the end of FY 2005, the Agency has completed a total of 7,817
tolerance reassessment decisions, addressing over 80 percent of the
9,721 tolerances that require reassessment. EPA is accomplishing
tolerance reassessment through both the registration and reregistration
programs by revoking tolerances for pesticides that have been canceled,
by reevaluating pesticides with pre-FQPA REDs, and through other
decisions not directly related to reregistration or registration. 

More specifics on the Agency’s progress in meeting its performance
measures and goals for pesticide reregistration will be published in the
Federal Register, as required by section 4(l) of FIFRA. 

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Other Activities

Use of Outside Reviewers

During FY 2005, the Agency explored mechanisms for enhancing its work
sharing efforts with Canada ’s Pest Management Regulatory Agency
(PMRA) and the California Department of Pesticide Regulation (CDPR). In
FY 2005, two new active ingredient reviews were completed as part of the
Joint Review Program under the North American Free Trade Agreement
(NAFTA). Currently, four active ingredients (two conventional chemicals
and two biopesticides) are being jointly evaluated by the EPA and PMRA
as part of the NAFTA Joint Review Program. Through this process, EPA
makes its own registration decision while sharing the risk assessment
work. To increase the number of joint reviews, EPA is exploring the
barriers to initiating biopesticide joint reviews. In addition, a
work-share project on the new active ingredient, metaflumizone, has been
initiated with the Pesticide Safety Directorate, United Kingdom . 

EPA has also been working with CDPR to expand their capacity to review
residue chemistry studies and conduct dietary risk assessments in
support of registration decisions. During FY 2005, 25 crop combinations
were reviewed through this joint effort. 

During FY 2005, the Agency encouraged registrants to submit electronic
data evaluation records for studies in support of new active
ingredients. This innovation facilitates data interpretation and
conserves Agency resources, permitting more rapid decisions,
particularly for reduced risk chemicals. 

Performance-Based Contracts

Contractors tasked with the review of hazard data were trained in the
selection of endpoints and characterization of hazards for human health
risk assessment. These contractor services enhanced the production of
human health risk assessments.

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Appendix A: Decision Review Types for Actions Completed During FY2005

As required by Section 33(k) of PRIA, the following table, as an Excel
file, provides the decision times for each decision (application) during
FY 2005. Note that decision times indicated in red with an asterisk are
decisions completed before the Agency received payment or a waiver was
granted. Completion of a registration action before payment is received
typically occurs in situations where a voluntary fee payment has been
offered for an application that was pending with the Agency prior to
March 23, 2004 (the PRIA effective date). Mandatory decision time frames
changed for some PRIA action codes and fee categories between FY 2004
and FY 2005. A decision’s time frame is based on the fiscal year in
which the application is received. Mandated time frames can be found in
the fee schedule published in the (  HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2004/March/Day-17/p6001.htm" 
Pesticides; Fees and Decision Times for Registration Applications ,
March 17, 2004), Federal Register. The Agency’s target due date for
completing a decision or action is based on 30 days in a month. The time
frames specified in the Consolidated Appropriations Act of 2004 are in
months. In the table, if the PRIA due date was met, while the Agency’s
target date was not, a date was entered in the column labeled PRIA Due
Date. All but four decisions or actions met the Agency’s target date,
negotiated due date, or PRIA due date. As EPA improves its reporting
capabilities, the Agency may update this table, as necessary. 

  is needed to view this file.)

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