GUIDING PRINCIPLES for DATA REQUIREMENTS
5-31-2013
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington DC, 20460

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GUIDING PRINCIPLES for DATA REQUIREMENTS
Office of Pesticide Programs
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to
register pesticides and require supporting studies as stipulated under 40 Code of
Federal Regulations (CFR) Part 158 to meet statutory safety standards. Part 158 also
establishes data requirements for pesticide tolerances under section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA). The studies in Part 158 provide the scientific
basis for characterizing the potential risks associated with pesticide exposure. There is
flexibility, however, in implementing Part 158. Additional data can be required (§158.75),
alternative approaches can be accepted, and studies can be waived (§158.45).
These guiding principles for data requirements will enable OPP staff to focus on the
information most relevant to the assessment. The goal is to ensure there is sufficient
information to reliably support registration decisions that are protective of public health
and the environment while avoiding the generation and evaluation of data that does not
materially influence the scientific certainty of a regulatory decision. It is important to only
require data that adequately inform regulatory decision making and thereby avoid
unnecessary use of time and resources, data generation costs, and animal testing.
Delayed regulatory decisions affect the delivery of health and environmental protections
and access to benefits such as pest management tools and safer products.
OPP has a long history of practicing flexibility in implementing Part 158 data
requirements. The guiding principles re-emphasize this practice in the context of new
and emerging tools which may be used to support risk assessment and risk
management decisions. Databases of relevant information have grown, and our
understanding of hazards and risks associated with pesticide exposures has advanced
overtime. Furthermore, research initiatives {e.g., EPA's Chemical Safety for
Sustainabilitv Research Program) will develop new predictive technologies that will
enhance our ability to evaluate chemicals and their effects of concern for a given
exposure scenario. These science developments will advance OPP's strategic direction
of using "Integrated Approaches to Testing and Assessment", which like these guiding
principles, promotes a hypothesis based, systematic, integrative use of exposure and
hazard information. Full use of existing knowledge and the integration of different types
of information to focus assessments appropriately are concepts consistent with the
2007 and 2009 National Research Council reports, Toxicity Testing in the 21st Century:
A Vision and a Strategy and Science and Decisions: Advancing Risk Assessment.
The following principles are intended to help guide the identification of data needs,
promote and optimize full use of existing knowledge, provide consistency in the data
request process across all scientific disciplines and all OPP divisions, and focus on the
data needed to allow for a scientifically sound and credible characterization of a specific
pesticide's risk profile for the exposure scenarios of interest.
These principles apply both to review of registration applications for new chemicals or
uses and re-evaluation of existing pesticide uses through registration review.

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I.	Principles for Problem Formulation/Risk Management1
a.	There needs to be sufficient data available to make a risk management
decision for each pesticide exposure scenario of interest.
i.	The level of certainty/uncertainty, relative to the available data, should be
acceptable for the risk management decision(s) being made. If risks are low
based on low expected toxicity or low estimated exposures (relative to the
available toxicity data), additional confirmatory data may not be needed to
make a risk conclusion. Therefore, it is important to characterize the nature
and source of uncertainties and their impact on the risk assessment
conclusions. A plausible range of potential risks and the characterization of
confidence/uncertainty around that range should be presented {e.g., EPA's
Risk Characterization Handbook). This characterization is particularly
important if the cost of mitigating is high or the risks are high if exposures
are not reduced.
ii.	Additional data should be required only if expected to improve the utility of
the risk assessment for decision-making (i.e., make a difference in risk
conclusions, including those for Federally-listed species, and risk mitigation
decisions) (e.g., see guidance on EPA Focus Meetings and an example in
the assessment for cryolite (p. 2)).
b.	Before requesting data, risk management options (e.g., lower application rates,
reduced number of applications, engineering controls, requirement for buffer
zones, etc.) should be considered (being mindful of the practicality and cost of
the management options). Potentially, exposure could be sufficiently reduced
such that new data to refine the risk assessment would not be necessary.
II.	Principles for Risk Assessment
a.	The decision to request data for a pesticidal substance should start with the 40
CFR §158.45 data requirements relevant to each scientific discipline for the
various types of pesticides (i.e., conventional, microbial, antimicrobial, and
biochemical active ingredients). In some cases, not all of the 'required' or
'conditionally required' data may be triggered or needed. In other cases,
additional data beyond the established requirements may be important to the
risk management decision.
b.	"Starting from scratch" should be avoided if possible; instead, there should be a
reliance on what is already known about the pesticidal substance and the
uses(s) being assessed. The decision to request data should be built on
previous risk assessments when available.
1 The design of a risk assessment and the information and technical analyses relevant to risk management are
identified in the problem formulation stage. See EPA's Guidelines for Ecological Risk Assessment for a conceptual
model of problem formulation phase of ecological risk assessments)

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c.	The scientific rationale for requesting data in the context of the risk assessment
and risk management decision should be clear, transparent and consistent both
within and across OPP Divisions.
i.	It is important to maintain clear distinctions among facts (data), assumptions
("best professional judgment", specific to an assessment, made in the
absence of specific data), and science policy decisions (principles that guide
scientific decisions e.g., EPA's Risk Characterization Handbook which
emphasizes transparency, clarity, consistency, and reasonableness in risk
characterization (see Section 1.3) USEPA, 2000).In particular, transparency
provides explicitness in distinguishing between data and assumptions as
well as articulating the logic and rationale around conclusions.
ii.	Because of the uncertainties associated with risk assessment, a qualitative,
semi-quantitative, and/or quantitative consideration of the strengths and
weaknesses of the available hazard and exposure data that impact the risk
conclusions (built on information from previous risk assessment(s), if
possible) should be presented.
d.	The decision to request or not request data should be based on a weight-of-
evidence (WoE) approach and should be related back to the "Problem
Formulation" (e.g., USEPA. 2011 presents a weight of evidence analysis that
will be used by EPA to evaluate results from the EPA Endocrine Tier 1
Screening program to identify candidate chemicals for Tier 2 testing). Things to
consider in the WoE approach are:
i.	Nature of exposure and hazard (using multiple lines of evidence from in vivo
studies, incident data, quantitative structure-activity relationship models, in
vitro assays, information on related compounds, etc.).
ii.	Mode of pesticide action and mode of toxicity action.
iii.	Other information beyond required studies (e.g., open literature, government
reports, international assessments) (e.g., USEPA Guidance for Identifying.
Selecting and Evaluating Open Literature Studies promotes the
consideration of multiple sources of information when conducting risk
assessments for pesticides, not just studies conducted specifically to
support pesticide registration, and provides guidance to make transparent to
the public how OPP identifies, selects, and ensures that the data used in
pesticide risk assessments is of sufficient scientific quality).
iv.	Bridging data across pesticidal substances and/or taxa (e.g., formation of
chemical categories and read across methods using in vivo or in vitro data,
(Q)SARs, etc.). Recent examples of this approach include a bridging
analysis of pyrethroids in ecological risk assessment and the evaluation of
data from neurodevelopmental studies on pyrethroids and consideration of

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comparative sensitivity. QSAR guidance provides assistance on evaluating
predicted activities and properties of untested chemicals based on their
structural similarity to chemicals with known activities and properties
(NAFTA TWG, 2012).
v. How the expected/predicted exposure values relate to the expected/
predicted/empirical hazard values in the context of the uncertainty
characterization {e.g., if exposure estimates are well above the hazard
values, then additional data may not be needed or vice versa) {e.g., Section
5. Risk Characterization of USEPA, 1998).
e. Resources should be focused appropriately regarding the need to refine a risk
assessment using integrated, hypothesis-based tiered approaches based on
what is known about the toxicity potential and the pesticide uses/exposure.
III. Summary
These guiding principles are intended to encourage creative thinking and innovation,
and guide OPP scientists as to the factors that should be considered in determining
what data are needed to adequately assess risks to pesticides. The rationale for
data determinations (to require, waive, or rely on data from similar pesticides) should
be transparently documented. Although a chosen path may implicate data
compensation issues, which would need to be considered and addressed, this
should not factor into the decision, scientific considerations should be foremost in
determinations of the need for data. However, care should be taken to identify
potential data compensation issues for the risk manager.
OPP staff is encouraged to seek advice from the appropriate review committees as
necessary. For example, to facilitate and ensure consistency regarding data
decisions, OPP recently established a new committee, the Hazard Science Policy
Committee, as a central forum and advisory body for discussing critical issues
identified in pesticide human health risk assessment. Similarly, the De Minimis
Review Committee was also recently established jointly under OPP's Science Policy
Council and OPP's Risk Manager's Forum to ensure scientific robustness and
consistency around cases that suggest that additional data and a quantitative
assessment are not needed to evaluate ecological or human health risks, thus
allowing the focus of resources on higher risk scenarios.
Although this document was prepared for OPP staff, these principles are generally
viewed as guidance for data waiver requests by registrants (whose responsibility is
to show that their pesticidal substance(s) meets the FIFRA and FFDCA protection
standards).

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References
NAFTA TWG 2012. (Quantitative) Structure Activity Relationship [(Q)SAR] Guidance
Document. North American Free Trade Agreement (NAFTA) Technical Working Group
on Pesticides (TWG), Nov. 2012.
NRC 2007. Toxicity Testing in the 21st Century: A Vision and a Strategy. National
Research Council (NRC), National Academy of Sciences, Washington, D.C. 2007
NRC 2009. Science and Decisions. National Research Council (NRC), National
Academy of Sciences, Washington, D.C. 2009,
USEPA2000. Risk Characterization Handbook. U.S. Environmental Protection Agency
(USEPA), Science Policy Council, Washington, DC 20460. December 2000.
USEPA 1998. Guidelines for Ecological Risk Assessment. Risk Assessment Forum.
U.S. Environmental Protection Agency (USEPA), Washington, DC 20460. May 14,
1998.
USEPA 2011. Endocrine Disruptor Screening Program: Weight-of-Evidence: Evaluating
Results of EDSP Tier 1 Screening to Identify the Need for Tier 2 Testing. Office of
Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency
(USEPA), Washington, DC 20460. Sept. 4, 2011.

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