EPA Is at Risk of Not Achieving Special Local Needs Program Goals for Pesticides

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Report Contributors:
Erin Barnes-Weaver
Jaya Brooks
Sarah Davidson
Jeffrey Harris
Natasha Henry
Lauretta Joseph
Thane Thompson
Abbreviations
AAPCO American Association of Pesticide Control Officials
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
OIG Office of Inspector General
OPP Office of Pesticide Programs
SLN Special Local Needs
Cover Photo: The Mediterranean fruit fly is one of the world's most destructive fruit pests.
It can infest hundreds of varieties of fruits, vegetables, and nuts.
(U.S. Department of Agriculture photo)
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^£DSr/|\ U.S. Environmental Protection Agency February 10 2021
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l Office of Inspector General
M' At a Glance
Why We Did This Evaluation
The U.S. Environmental
Protection Agency's Office of
Inspector General conducted
this evaluation to determine
whether management controls
within the EPA's Special Local
Needs registration program
effectively promote the EPA's
goals of risk reduction and
pollution prevention, as stated in
its strategic plan. The EPA's
SLN program—which is
managed by the Office of
Pesticide Programs, or OPP—
allows states to register
pesticides to address existing or
imminent pest problems within a
state for which an appropriate
federally registered pesticide
product is not available. Most
SLN registrations are issued for
pesticide products that the EPA
has registered but that are
unapproved for a specific crop
or use. The EPA reviews SLN
applications to determine
whether they are protective of
human health and the
environment.
This evaluation addresses the
following:
• Ensuring the safety of
chemicals.
This evaluation addresses top
EPA management challenges:
• Complying with key internal
control requirements (policies
and procedures).
• Overseeing states
implementing EPA programs.
Address inquiries to our public
affairs office at (202) 566-2391 or
OIG WEBCOMMENTS@epa.gov.
EPA Is at Risk of Not Achieving Special Local
Needs Program Goals for Pesticides
Without a sufficient
management-control
system and other
improvements, the SLN
program will not effectively
promote risk reduction and
pollution prevention.
What We Found
The SLN program lacks three components that
would improve its effectiveness: a comprehensive
system of management controls to achieve the
Agency's goals of risk reduction and pollution
prevention, a publicly accessible database, and a
method of effective communication with program
stakeholders. For example, without a public SLN
database, stakeholders cannot access relevant
information for their states, and states cannot use examples from other states to
make better decisions about when to grant an SLN registration.
Specifically, we found that the OPP has not developed performance measures that
would demonstrate the progress or effectiveness of the SLN program and the OPP
does not collect data to demonstrate the risk reduction and pollution prevention
results of the program. In addition, the OPP does not have standard operating
procedures in place to oversee the implementation of the program. An SLN
registration is effective as soon as the state approves the application unless the EPA
disapproves it. Without a consistent and effective application review process, human
health and the environment may be at risk. Further, we determined that the OPP
needs detailed guidance to assist states in developing consistent SLN registration
applications.
We also found that the OPP does not have an SLN database that would allow state
stakeholders to review the approved SLN registrations and labels of other states
while those stakeholders prepare their own applications. Finally, we found that the
OPP does not consistently communicate to its stakeholders.
Recommendations and Planned Agency Corrective Actions
We recommend that the assistant administrator for Chemical Safety and Pollution
Prevention develop management controls for reviewing SLN registrations; improve
guidance to states for SLN registration submissions; make an SLN database
available to the public that includes registration date, duration, and individual state
SLN labels; develop performance measures and collect data to demonstrate
risk-reduction and pollution-prevention outcomes; and inform states of the availability
of presubmission consultative services.
The Agency agreed with our recommendations and provided acceptable corrective
actions and estimated completion dates. The recommendations are resolved with
corrective actions pending.
List of OIG reports.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
February 10, 2021
MEMORANDUM
SUBJECT: EPA Is at Risk of Not Achieving Special Local Needs Program Goals for Pesticides
Report No. 21-E-0072
This is our report on the subject evaluation conducted by the Office of Inspector General of the
U.S. Environmental Protection Agency. The project number for this evaluation was QA&E-FY20-0123.
This report contains findings that describe the problems the OIG has identified and corrective actions the
OIG recommends. Final determinations on matters in this report will be made by EPA managers in
accordance with established audit resolution procedures.
The Office of Chemical Safety and Pollution Prevention is responsible for the issues discussed in this
report.
In accordance with EPA Manual 2750, your office provided acceptable planned corrective actions and
estimated milestone dates in response to OIG recommendations. All recommendations are resolved with
corrective actions pending, and no final response to this report is required. If you submit a response,
however, it will be posted on the OIG's website, along with our memorandum commenting on your
response. Your response should be provided as an Adobe PDF file that complies with the accessibility
requirements of Section 508 of the Rehabilitation Act of 1973, as amended. The final response should not
contain data that you do not want to be released to the public; if your response contains such data, you
should identify the data for redaction or removal along with corresponding justification.
FROM: Sean W. O'Donnell
TO:
Michal liana Freedhoff, Acting Assistant Administrator
Office of Chemical Safety and Pollution Prevention
We will post this report to our website at www.epa.gov/oig.
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EPA Is at Risk of Not Achieving Special 21-E-0072
Local Needs Program Goals for Pesticides
Table of C
Purpose 1
Background 1
Responsible Office 4
Scope and Methodology 4
Results 4
SLN Program Does Not Have a Comprehensive System of
Management Controls 5
OPP Has Not Identified Program Objectives, Developed Performance
Measures, or Implemented Data Collection 5
OPP Does Not Have Uniform Review Processes 6
OPP Does Not Provide Adequate Guidance to States 6
OPP Lacks SLN Database for Public and Stakeholder Use 7
OPP Does Not Effectively Communicate with State Partners 7
Conclusion 9
Recommendations 9
Agency Response and OIG Assessment 10
Status of Recommendations and Potential Monetary Benefits 11
Appendices
A Agency Response to Draft Report 12
B Distribution 15
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Purpose
The U.S. Environmental Protection
Agency's Office of Inspector General
conducted this evaluation to determine
whether management controls within the
EPA's Special Local Needs, or SLN,
pesticide registration program
effectively promote the EPA's goals of
risk reduction and pollution prevention.
Background
Pesticide Registrations
According to the EPA, the primary purpose of the Federal Insecticide, Fungicide,
and Rodenticide Act, or FIFRA, is to ensure that, when applied as instructed,
pesticides will not generally cause unreasonable risk to human health or the
environment. Pesticides are chemicals used to curb unwanted vegetation, insects,
animals, or bacteria. Because they are poisons, pesticides can create acute and
chronic issues that affect human health and can cause environmental harm.
Generally, pesticides distributed or sold in the United States must be registered by
the EPA.
Before the EPA registers a pesticide under FIFRA, the manufacturer or
formulator, also known as the registrant, must show, among other things, that
using the pesticide according to the instructions on the label "will not generally
cause unreasonable adverse effects on the environment." The EPA's review of
pesticide registrations works to reduce the human health and environmental risks
of pesticide use and prevent pollution through the control of when, where, and
how people can use pesticides. Under the requirements of FIFRA, a registrant
must register a product for each specific use. Registrants must submit new
applications each time they:
• Register a new pesticide active ingredient.
• Register a new product for an existing pesticide active ingredient.
• Add a new use to an existing product registration.
Special Local Needs Pesticide Registrations
Section 24(c) of FIFRA allows states to grant state-level pesticide registrations to
address pest problems that arise in their states for which no pesticide registration
exists. These state-level registrations are intended to address the special local
needs of a specific state and are referred to as SLN. The EPA defines an SLN as:
Top Management Challenges
This evaluation addresses the following top
management challenges for the Agency, as
identified in OIG Report No. 20-N-0231. EPA's
FYs 2020-2021 Management Challenges, issued
July 21, 2020:
• Complying with key internal control
requirements (policies and procedures).
• Overseeing states implementing EPA programs.
21-E-0072
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An existing or imminent pest problem within a State for which the
State lead agency, based upon satisfactory supporting information,
has determined that an appropriate federally registered pesticide
product is not sufficiently available.1
As of May 2020, there were about 2,100 SLN registrations in place across the
country. According to the Office of Pesticide Programs, or OPP, the SLN
program receives about 300 SLN applications per year. Since the passage of
FIFRA, the EPA has allowed states to add uses to a registered pesticide, as well as
impose more restrictions on specific pesticide uses, based upon the state's need.
Most SLN registrations expand the scope of a federally registered pesticide by
adding an intended use for that pesticide, such as:
• An additional crop that people can use the pesticide on.
• An additional application method or timing.
In some cases, the SLN registration imposes additional restrictions that limit the
use of a federally registered pesticide.
The EPA reviews each SLN registration to determine whether it meets the
requirements of FIFRA. Once a state issues an SLN registration, it becomes
effective immediately. However, after the state submits the SLN registration to
the EPA, the EPA has up to 90 days to review it. The EPA can disapprove the
registration if it does not meet SLN requirements. For example, if the additional
use outlined within the SLN registration was previously denied, disapproved,
suspended, or canceled by the EPA administrator, the EPA may disapprove the
registration (Figure 1).
Figure 1: The SLN process

A state

The SLN

After

The EPA

grants a

issuance,

has up
to 90 days
to
disapprove
the SLN
registration.
A state

state-level

registration

the state

identifies a
special

pesticide
registration
*
is active
upon

submits an
SLN
*
local need.

to address
the special
local need.

issuance by
the state.

registration
to the EPA
for review.

Source: OIG analysis. (EPA OIG image)
States are responsible for submitting SLN registrations to the EPA. According to
the SLN program's website, the program aims to quickly process SLN
registrations and to "promote the EPA's goals of risk reduction and pollution
prevention." The EPA's SLN program provides a general guidance document on
its website that outlines certain steps for submitting an application packet.
1 40 C.F.R. § 162.151.
21-E-0072
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According to the guidance document on the website, an SLN application package
should include:
• A properly completed Notification of State Registration (EPA Form 8570-
25). All requested information on the application form should be provided.
• A cover letter with a description of what special local need is being met by
the issuance of the 24(c) [SLN application] and a clear explanation of how
the definition of special local need is met.
• A copy of the labeling approved by the state.
• A properly completed copy of the Confidential Statement of Formula
(CSF)[.] Note: Only required if the product is not federally registered.
Management Controls
Every federal program is required to have internal controls. Management is
responsible for an effective internal control system, which we refer to in this
report as management controls. Management controls comprise the plans,
policies, and procedures used to implement the regular operation of the program,
as well as to achieve the program's goals and objectives. As shown in Figure 2,
management controls provide a process by which the program's objectives may
be achieved. First, the objective of the program is identified. Second, management
controls are developed and implemented with the reasonable expectation of
achieving the objective.
Figure 2: Achieving objectives through internal controls
^ ^ *
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evaluate performance in achieving objectives. The Office of Management and
Budget's Circular No. A-123. Management's Responsibility for Enterprise Risk
Management and Internal Control, requires that federal managers implement
Green Book standards and defines management's responsibilities for the risk
management process.
Responsible Office
The OPP within the Office of Chemical Safety and Pollution Prevention manages
the SLN program.
Scope and Methodology
We conducted this evaluation from March to December 2020 in accordance with
the Quality Standards for Inspection and Evaluation, published in January 2012
by the Council of the Inspectors General on Integrity and Efficiency. Those
standards require that we perform the evaluation to obtain sufficient, competent,
and relevant evidence to provide a reasonable basis for our findings, conclusions,
and recommendations based on our objective. We believe that the evidence
obtained provides a reasonable basis for our findings, conclusions, and
recommendations.
We reviewed statutory and regulatory language, guidance, and procedure
documents. We analyzed a judgmental sample of five SLN registration
applications from several states, as well as data from the OPP internal database.
Finally, we interviewed staff from the OPP, representatives from six states
participating in the SLN program, and two external stakeholders to gather their
perspectives.
Results
The EPA's SLN program lacks three components that would improve the
program's effectiveness:
• A comprehensive system of management controls to enable the achievement
of the program goal of risk-reduction and pollution-prevention.
• A publicly accessible database.
• An effective method of communication with program stakeholders.
Specifically, we found that the OPP has not developed a comprehensive system of
management controls, including:
• Robust processes to consistently review SLN applications.
• Detailed guidance to oversee the implementation of the program.
21-E-0072
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• Measures and data-collection methods to determine the risk-reduction and
pollution-prevention outcomes of the SLN program.
We also determined that the OPP does not provide an SLN database to the public
or the program's state stakeholders. Finally, we found that the OPP does not
consistently or effectively communicate its SLN registration oversight role to its
state partners. Without a system of management controls, publicly available data,
and clear and consistent stakeholder communication, the SLN program is at risk
of not effectively promoting risk reduction and pollution prevention.
SLN Program Does Not Have a Comprehensive System of
Management Controls
The OPP does not have a comprehensive system of management controls in place
to effectively implement the SLN program. The OPP has not developed
performance measures or implemented a data-collection method. The OPP has no
uniform process for reviewing SLN applications from the states, and it does not
provide detailed guidance to assist states in submitting consistent SLN
applications.
OPP Has Not Identified Program Objectives, Developed Performance
Measures, or Implemented Data Collection
As mentioned previously, the OPP has identified an overall goal to promote risk
reduction and pollution prevention for the SLN program. However, it has not
identified SLN program objectives and, as a result, cannot and develop
performance measures or implement a data-collection method to determine the
effectiveness of the SLN program.
Because there are no performance measures for the program, the OPP has not
identified what data it needs to collect from the states
to measure risk reduction or pollution prevention.
This data gap is a substantial concern, since one state
reported challenges in conducting the risk assessments
to successfully complete SLN applications. Without
program objectives, performance measures, or a data-
collection process, the SLN program cannot
demonstrate how it reduces risk or prevents pollution.
OPP Does Not Have Uniform Review Processes
According to the SLN website, the EPA's role is to assure that each SLN
registration meets the requirements of FIFRA and to conduct general oversight by
periodically reviewing the EPA's records of 24(c) registrations to ensure that
states and the EPA have properly followed procedures and policies. We found
Per the Green Book, a
performance measure is a
"means of evaluating the
entity's performance in
achieving objectives." The
entity establishes
performance measures to
gauge progress toward its
objectives.
21-E-0072
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that the OPP does not have a uniform review process when it assesses the SLN
registrations submitted by states. Three separate OPP divisions conduct reviews
of SLN applications. Which division reviews an application depends upon the
type of pesticide application submitted. When we requested written procedures
from the OPP, we found that each division uses a different checklist to review the
completeness of SLN application packages. However, beyond a checklist that
verifies completeness, no consistent or standardized system of review, such as
standard operating procedures, for all SLN applications had been developed.
Further, when we reviewed a small sample of SLN applications, we found that
only three of five applications even included a "Review Summary Sheet"
checklist.
OPP Does Not Provide Adequate Guidance to States
The OPP does not provide detailed guidance to assist states in submitting
consistent SLN applications. Currently, the OPP relies on a general guidance
document on the SLN website as a resource for states to use when submitting an
SLN registration. The SLN website states that the:
[GJuidance document is intended to empower the states to operate
as independently as possible to reduce the resources EPA uses to
review 24(c) applications and to assure the public that no
unreasonable adverse effects will occur from [SLN] registrations.
However, the website does not provide a systematic process to help a registrant
accurately and consistently provide all the information that the EPA needs to
ensure that "no unreasonable adverse effects will occur." For example, the
guidance says that states should not submit data to the EPA for review unless they
are unable to make an "unreasonable adverse effects" determination, but the
guidance does not provide any criteria to make that determination.
In 2019, the American Association of Pesticide Control Officials, which is the
organization representing most state-level pesticide officials, developed a
proposed guidance document for SLN registrants. This draft guidance document
is cohesive and contains, in one place, all the information a state would need to
complete an SLN registration. State representatives from one state we interviewed
indicated that they would benefit from the EPA's adoption of the AAPCO draft
guidance. We found that the AAPCO document clearly outlines the specific
information and procedures required to successfully submit an SLN registration.
The AAPCO draft guidance also states that it:
[CJlarifies the regulations implementing Section 24(c) of the
Federal Insecticide, Fungicide and Rodenticide Act... to assist
FIFRA state lead agencies ... in submitting complete Section 24(c)
notification submissions to EPA; and to facilitate EPA's review.
Stakeholders may also find this guidance helpful to better
21-E-0072
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understand the purpose and processes of Section 24(c)
registrations.
The association presented the guidance to the EPA. Though the EPA consulted in
the development of this draft guidance, the Agency has not adopted it. Instead, the
OPP continues to rely on its guidance document provided on the SLN program
website. OPP management later stated to us that it does not plan to adopt the
AAPCO guidance but that the AAPCO guidance is available for states to use
without the EPA's endorsement.
OPP Lacks SLN Database for Public and Stakeholder Use
The OPP does not have a publicly accessible database to track SLN registrations.
The EPA stated that it has an internal tracking system called the Office of
Pesticide Programs Information Network database. The database tracks some
information for the SLN program, but it does not track key information, such as a
description of what SLN the specific registration addresses. Representatives from
four of the six states we spoke with said that they would like for the EPA to
develop a publicly accessible SLN database that specifically includes all approved
SLN labels.
The lack of a publicly available database prevents the public from being able to
review and compare all approved SLN applications and labels. Further, the state
representatives we interviewed said that this information would be helpful when
developing their SLN applications. EPA staff members stated that they are
developing a public database. However, they could not provide a timeline for its
completion or implementation. Without a public SLN database, stakeholders
cannot access relevant information for their state or use examples of registrations
approved for other states to make decisions about when to grant SLN
registrations.
OPP Does Not Effectively Communicate with State Partners
The EPA is also not regularly communicating with states about the assistance it
provides for SLN registrations. First, the OPP stated that it provides informal
consultative services to states prior to submitting an SLN application. These
services include technical assistance and training. The OPP maintains that it
communicates with states and stakeholders and that these services are available to
them if they are needed. We reviewed the OPP's 2020 annual letter to states
regarding the emergency exemption program and the SLN program. While the
letter provided information about consultative services for emergency
exemptions, it did not specifically discuss consultative services available to states
developing SLN registrations. In our discussions, four states indicated that they
were aware of and had requested preliminary consultation with the EPA before
SLN submissions. However, one state indicated it was unaware that consultative
services were available, while another state did not indicate whether it had
21-E-0072
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requested assistance. The OPP needs to better communicate about this service, as
the states we spoke to differed in their understanding of the consultative services
available.
Second, the OPP informed us that it does not review or provide for a systematic,
consistent review of the human health and environmental risk data of each SLN
registration if the product has already completed a national registration for a
different use. Rather, the OPP informed us that it relies on the states to
independently conduct any necessary assessments and to provide assurance to the
OPP that the SLN registration has received sufficient review. Yet, some states
may lack the capabilities to perform the required level of review. Representatives
from three of the six states we interviewed informed us that they do not have the
staff resources or expertise to review the technical information in SLN
registrations. Of these states:
• One state indicated that it did not have a toxicologist on staff and relied on
the EPA to review safety and health risk factors.
• Another state indicated that it did not have the resources to conduct
product testing.
In both cases, these resource-challenged states said that they relied on the EPA to
review health and safety data for each SLN registration. Because this assumption
was, in fact, incorrect, the states introduced risk to the SLN application review
process. To mitigate this risk, clear communication is needed with states
regarding the level of review that the EPA is conducting and the consultative
services that are available to states to assist them with SLN applications.
Third, in spring 2019, the OPP posted a notice on its SLN program website stating
that it was reevaluating its approach to reviewing SLN registrations that impose
restrictions on pesticide use, possibly making it harder for states to impose such
restrictions. SLN restrictions are seldomly used unless the federally approved
pesticide would negatively impact a locally specific resource. For example,
restrictions have been used to protect groundwater where water tables were too
close to the surface. All representatives from the six states we interviewed
stressed the importance of the ability to restrict pesticides based upon their own
local needs and encouraged the EPA to retain the option of permitting states to
restrict pesticide uses through the FIFRA 24(c) registration process. Nearly two
years later, on October 27, 2020, in a footnote in an SLN pesticide registration
approval decision, the EPA stated a policy change about the ability of states to use
SLN registrations to restrict the use of pesticides.2 Instead, the decision directed
states to register restrictions of pesticides under section 24(a) of FIFRA. This new
policy reversed a policy that had been in place since at least 1996 and that
allowed states to restrict pesticide use through the more streamlined FIFRA 24(c)
registration process.
2 EPA, Memorandum Supporting Decision to Approve Registration for the Uses of Dicamba on Dicamba
Tolerant Cotton and Soybean, October 27, 2020.
21-E-0072
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Last, because of the coronavirus pandemic, the OPP began allowing the electronic
submission of SLN applications. Previously, states had to mail their applications.
States indicated that this was a positive change, but some states were unsure
whether this was a permanent change. In November 2020, the OPP clarified
matters by updating its website to indicate that electronic submissions were now
preferred.
As discussed above, the EPA has several areas where communication needs to be
improved. Clear and consistent communication with states will result in robust
SLN applications that can help the EPA meet its goal of risk reduction and
pollution prevention. Given the information gathered from our state interviews,
the OPP's inconsistent and ineffective communication of its oversight role to state
partners increases the risk to human health and the environment.
Conclusion
The OPP has not developed management controls that are necessary to achieve
the goals of the SLN program. As a result, the SLN program does not have
consistent application review processes, does not provide detailed guidance for
state partners, and does not have performance measures or a data-collection
process. Also, the OPP has not developed a public database for states and the
public to access and review. Finally, the OPP is not consistently communicating
with stakeholders as they develop their SLN applications. Without a specific
system of management controls, a publicly accessible database, and improved
stakeholder communication, the SLN program is at risk of not meeting the
program goals of risk reduction and pollution prevention.
Recommendations
We recommend that the assistant administrator for Chemical Safety and Pollution
Prevention:
1. Develop program objectives and measures and implement data-collection
processes to determine the risk-reduction and pollution-prevention
outcomes of the Special Local Needs program.
2. Develop and implement standard operating procedures that allow Special
Local Needs applications to be reviewed consistently.
3. Determine whether the Office of Pesticide Programs will adopt the draft
American Association of Pesticide Control Officials guidance or develop
detailed guidance for states that specifies what information should be
submitted in each Special Local Needs application.
21-E-0072
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4. Develop and make available a public Special Local Needs database
including registration date, duration, and individual state Special Local
Needs labels for each Special Local Needs registration.
5. Regularly inform states of the availability of presubmission consultative
services to develop effective Special Local Needs application packages.
Agency Response and OIG Assessment
The Agency agreed with our recommendations and provided corrective actions
and completion dates for all recommendations. All recommendations are resolved
with corrective actions pending.
We included the Agency's full response to our draft report in Appendix A.
21-E-0072
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
Rec.
No.
Page
No.
Subject
Status1
Action Official
Planned
Completion
Date
Potential
Monetary
Benefits
(in $000s)
1
9
Develop program objectives and measures and implement data-
collection processes to determine the risk-reduction and
pollution-prevention outcomes of the Special Local Needs
program.
R
Assistant Administrator for
Chemical Safety and
Pollution Prevention
7/1/22

2
10
Develop and implement standard operating procedures that
allow Special Local Needs applications to be reviewed
consistently.
R
Assistant Administrator for
Chemical Safety and
Pollution Prevention
12/31/21

3
10
Determine whether the Office of Pesticide Programs will adopt
the draft American Association of Pesticide Control Officials
guidance or develop detailed guidance for states that specifies
what information should be submitted in each Special Local
Needs application.
R
Assistant Administrator for
Chemical Safety and
Pollution Prevention
12/31/21

4
10
Develop and make available a public Special Local Needs
database including registration date, duration, and individual
state Special Local Needs labels for each Special Local Needs
registration.
R
Assistant Administrator for
Chemical Safety and
Pollution Prevention
12/31/21

5
10
Regularly inform states of the availability of presubmission
consultative services to develop effective Special Local Needs
application packages.
R
Assistant Administrator for
Chemical Safety and
Pollution Prevention
6/30/21

1 C = Corrective action completed.
R = Recommendation resolved with corrective action pending.
U = Recommendation unresolved with resolution efforts in progress.
21-E-0072
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Q
*1 PRO^
Appendix A
Agency Response to Draft Report
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
MEMORANDUM
SUBJECT: Response to Draft Report entitled "EPA at Risk of Not Achieving Special Local
Needs Program Goals for Pesticides."
T A | A L_| C M D V D'stoHy s'9ned byTALA henry
FROM: TalaHenry 1 rtLM MtlNhY
Deputy Director for Programs, Office of Pollution Prevention and Toxics
Performing delegated functions of the Assistant Administrator of the Office of
Chemical Safety and Pollution Prevention
TO: Sean O'Donnell
Inspector General
This memorandum responds to the Office of Inspector General's (OIG) Draft Report entitled
"EPA at Risk of Not Achieving Special Local Needs Program Goals for Pesticides," Project No.
OA&E-FY20-0123, December 9, 2020.
I. General Comments:
The Office of Chemical Safety and Pollution Prevention (OCSPP) appreciates the OIG's effort in
evaluating the following:
• The EPA's oversight of the Federal Insecticide, Fungicide, and Rodenticide Act Section
24(c) special local need registrations. OIG's objective was to determine whether
management controls within the Section 24(c) registration program effectively promote
the EPA's goals of risk reduction and pollution prevention.
On November 12, 2020, OCSPP met with OIG to discuss OIG's Special Local Needs 24(c)
Program Evaluation Finding Outline. During that discussion and in response to OIG's Draft
Report, OCSPP expressed general agreement with OIG's recommendations.
21-E-0072
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II.
OCSPP's Response to the Recommendations:
The Draft Report contains recommendations for the Office of Chemical Safety and Pollution
Prevention's (OCSPP) Office of Pesticide Programs (OPP):
Recommendation 1: Develop program objectives and measures and implement data collection
processes to determine the risk reduction and pollution prevention outcomes of the Special Local
Needs program.
• Proposed Corrective Action 1: 40 CFR 162.154(c) requires EPA to make a final
decision on disapproval of a State registration, and provide written notification thereof to
the State, within 90 days of the effective date of the registration. To implement
Recommendation 1, OCSPP will undertake a data review effort to assess how the
Agency's review process is performing on the requirement to either disapprove or
acknowledge a 24(c) action within 90 days. Data collection will be undertaken for 12
months, followed by an evaluation of the collected data. Using this data, by July 1, 2022,
OCSPP will develop a performance measure to track how the program is performing
relative to the 90-day response timeline in 40 C.F.R. 162. The measure will include data
on the performance of the office regarding this timing goal. This analysis will inform
OCSPP on whether it is necessary to make changes to the review process in order to
achieve the 90-day requirement.
• Target Completion Date: July 1, 2022.
Recommendation 2: Develop and implement standard operating procedures that allow special
local need applications to be reviewed consistently.
• Proposed Corrective Action 2: OCSPP will develop and implement a programmatic
standard operating procedures (SOP) document to ensure consistent review of special
local need applications.
• Target Completion Date: December 31, 2021.
Recommendation 3: Determine whether the Office of Pesticide Programs will adopt the draft
American Association of Pesticide Control Officials guidance or develop detailed guidance for
states that specifies what information should be submitted in each Special Local Need
application.
• Proposed Corrective Action 3: On November 20, 2020, OCSPP added new information
about the FIFRA 24(c) program to its website: (https://www.epa.gov/pesticide-
registration/guidance-fifra-24c-
regi strati ons#:~:text=Special%20Local%20Need..product%20is%20not%20sufficientlv%
20available). OCSPP believes the information that is now available supports the states
working in this area. However, OCSPP will also engage with AAPCO to identify if any
additional supporting materials or guidance information is necessary to assist their work
on FIFRA 24(c) actions. Specifically, by December 31, 2021, OCSPP will solicit input
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from AAPCO to determine if additional guidance is needed beyond the new information
provided to the States posted on the FIFRA 24(c) website on November 20, 2020.
• Target Completion Date: December 31, 2021.
Recommendation 4: Develop and make available a public Special Local Needs database
including registration date, duration, and individual state Special Local Need labels for each
Special Local Need registration.
• Proposed Corrective Action 4: OCSPP agrees a public information resource with data
on Section 24(c) uses should be available. To accomplish this, OCSPP plans to make
special local need labels reviewed in OPP available through the Pesticide Product Label
System (PPLS) website https://iaspub.epa.gov/apex/pesticides/f?p=PPLS:l. This is an
enhancement to the PPLS database. Specifically, by December 31, 2021, OCSPP will
implement the enhanced functionality of the PPLS data base such that submitted special
local needs labels will be made available to the public via PPLS.
• Target Completion Date: December 31, 2021.
Recommendation 5: Regularly inform states of the availability of pre-submission consultative
services to develop effective Special Local Need application packages.
• Proposed Corrective Action 5: OCSPP will continue to support the States and commits
to providing regular and useful information to the States to assist with the development of
comprehensive special local need submission packages, including pre-submission
consultative services for Special Local Need actions.
• Target Completion Date: By June 30, 2021, OCSPP will contact all FIFRA State
partners to provide information on pre-submission consultations services available to
them.
cc: All OCSPP DAAs
Program Office OD, DOD
Christine El-Zoghbi, Deputy Assistant Inspector General for Evaluation
Chad Kincheloe, Acting Director, Toxics and Chemical Evaluations, OIG
Erin Barnes-Weaver, Acting Team Leader, OIG
Lauretta Joseph, Project Manager, OIG
Jaya Brooks, OIG
Sarah Davidson, OIG
Natasha Henry, OIG
Thane Thompson, OIG
Janet L. Weiner, OCSPP Audit Liaison
Cameo Smoot, OPP Audit Liaison
Connie Hernandez, OPP Audit Liaison
Andrew LeBlanc, OCFO AFC
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Appendix B
Distribution
The Administrator
Associate Deputy Administrator
Assistant Deputy Administrator
Chief of Staff
Deputy Chief of Staff
Assistant Administrator for Chemical Safety and Pollution Prevention
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
Director, Office of Continuous Improvement, Office of the Chief Financial Officer
Principal Deputy Assistant Administrator for Chemical Safety and Pollution Prevention
Deputy Assistant Administrators for Chemical Safety and Pollution Prevention
Director, Office of Pesticide Programs, Office of Chemical Safety and Pollution Prevention
Audit Follow-Up Coordinator, Office of the Administrator
Senior Audit Advisor, Office of Chemical Safety and Pollution Prevention
Audit Follow-Up Coordinator, Office of Pesticide Programs, Office of Chemical Safety and
Pollution Prevention
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