Pet Spot-On Enhanced Reporting
Registration Division
February 2018
(Updated August 2019)
This Pet Spot-On Enhanced Reporting Implementation document explains the Pilot program for use of
standardized templates, which was concluded in 2018, and the associated, tiered approach to data
analysis. In addition, this document serves to describe the implementation process for using EPA's
standardized templates for submitting enhanced reporting and sales data, which affects all Spot-On
products with registrations that require the submission of quarterly enhanced reporting. Pet spot-on
registrants may currently request a change to annual (versus quarterly) enhanced reporting if using the
templates issued following the conclusion of the Pilot in 2018. This document has been updated since
its original release to describe a process for also requesting removal of the conditional registration
expiration date when the standardized templates are used.
In 2008-2009 a notable increase in the number of reports of adverse health effects from pet spot-on
flea and tick control products was identified in EPA's Incident Data System (IDS). The IDS system
incorporates data submitted by registrants under the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA) section 6 (a)(2) in aggregate form on a quarterly basis. Aggregate reports include
information such as the number of incidents reported per quarter, severity of incidents, and the
products involved.
As a result of the increase, EPA required registrants of these products to submit enhanced incident
data for the year of 2008. Enhanced incident reporting includes more detailed information such as
exposure scenarios and associated clinical signs. The data were reviewed by EPA in 2009 with the
resultant report being released in 2010. As a result of the increased incident reports and data analysis,
EPA responded with mitigation measures including:
	2-year time-limited conditional registrations
	Label mitigation to clarify instructions for safe use and provide clear indicators to prevent
	Limitation of Confidential Statements of Formulations (CSFs) to one formulation
	Enhanced quarterly incident reporting with corresponding sales data

For additional and related information see EPA Evaluation of Pet Spot-on Products: Analysis and Plans
for Reducing Harmful Effects at https://www.epa.gov/pets/epa-evaluation-pet-spot-products-analysis-
Although these mitigation measures have been implemented, screening level analysis demonstrated
inconsistencies in the data submissions. Meaningful analysis of the data was not achievable with these
inconsistencies making it difficult to use for regulatory purposes. Lack of standard data fields, standard
terminology, and inconsistent formats are the deficiencies that facilitated the development of the Pet
Spot-On Enhanced Reporting Pilot.
The objective of the Pilot was to determine if use of standardized enhanced incident reporting and
sales templates would provide the data in a format that could be more readily analyzed which would
allow the Agency to review incidents more efficiently providing the necessary information on which to
act should concerns be raised. In addition, through the Pilot, EPA sought feedback from Pilot
participants and other interested stakeholders on the usability and feasibility of the templates which
was used to modify the templates as needed.
The Pilot was introduced on the web in May of 20161 and via open stakeholder webinar in June of 20162.
EPA asked for up to nine volunteer registrants to submit one year of enhanced incident reporting data
using the draft standardized reporting templates. Five registrants volunteered to participate in the Pilot
program submitting data for the 2016 year using the draft excel-based templates.
The first data submission was made by August 29, 2016 which included data for Q1 and Q2 of 2016
(January-June 2016). A teleconference was held pre-submission to facilitate initial use of the templates
and post submission to exchange feedback regarding the templates. Individual webinars were also held
to provide a more individualized forum for each registrant to discuss concerns, feedback, and data sets.
The final data submission for Q3 and Q4 of 2016 (July-December 2016) was made by February 28, 2017
completing the submission of one year of data using the draft templates provided by EPA.
Pilot results demonstrate that use of the standardized templates is feasible, and analysis by the health
Effects Division (HED) confirms that use of the templates does provide data in a format that can be
analyzed in a meaningful way.
introduction of Pilot on the web in May of 2016 https://archive.epa.gov/epa/pesticides/epa-plans-standardize-
2Open stakeholder webinar in June of 2016 https://www.epa.gov/pesticides/pilot-test-new-template-enhanced-

As outlined in the Memorandum drafted by HED dated January 23, 2018, EPA will adopt a tiered
approach for this analysis as described below:
Tier	Dulii Son roc	IK-scription	
Level 0: Aggregate OPP's Incident Data Descriptive analysis will be performed using OPP's Incident Data
Incident Data System System	System (IDS). IDS captures data on domestic animal (pet) incidents
Query	received under FIFRA 6(a)(2) from registrants and is reported in
aggregate form on a quarterly basis. IDS data includes the number
of incidents reported for quarter, severity of the incidents, products
implicated, but does not include species or any narrative information
regarding exposure scenario or symptoms.
RORs will be calculated using enhanced reporting data to compare
the odds of a given outcome (or event) for one product to odds of
(same) outcome to another. This analysis will likely evaluate the
ROR of Death (or Death+Major) incidents for each product vs. all
other products combined, by species.
IRRs will be calculated using enhanced reporting data to compare
the rate of a given outcome (or event) for one product to the rate of
(same) outcome to another. This will likely evaluate the IRR of
Death (or Death+Major) incidents for each product vs. all other
products combined, by species. Rates will be estimated using sales
data submitted as part of enhanced reporting.
Level 3: Signal-Based Spot-on Enhanced This signal-based case-by-case review evaluates cases on an
Case-by-Case Review Reporting Data individual basis and incorporates information in the submitted
& Causality Analysis	narrative. This may involve investigating IRR on a symptom rather
than a product basis and may incorporate causality analysis.
Level 1: Reporting Spot-on Enhanced
Odds Ratio (ROR), by Reporting Data
Severity Outcome
Level 2: Incident Rate Spot-on Enhanced
Ratio (IRR), by	Reporting Data
Severity Outcome
EPA understands that - for all levels or tiers described above - that signals are signals only, representing
simple "disproportionalities" (sometimes referred to as SDR (signals of disproportionate reporting)).
Such signals are considered to be hypotheses and do not necessarily imply causal relationships between
the exposure and the health effect or outcome. Signal detection does not replace hands-on clinical
review of case reports and veterinary medical judgment. Also the limitations and biases associated with
reported data may limit utility, will require cautious interpretation. Nevertheless, EPA believes that the
methods described above and use of the newly-developed standardized incident reporting template-
will considerably improve the ability of the Agency to evaluate the data it receives and ensure the
continued safety of these products.

EPA is now inviting all pet spot-on registrants to adopt use of the standardized enhanced incident and
sales reporting templates for annual enhanced reporting. Submission of annual enhanced reporting
allows for a comprehensive analysis of data that complements the existing quarterly submission of
6(a)(2) incident data, a requirement of FIFRA. EPA believes that submission of the enhanced reporting
on an annual basis is adequate because it will allow the Agency to assess trends in incidents over a
comparable period of time that is independent of seasonal shifts in usage. Seasonal shifts on the use
patterns of spot-on products will continue to be monitored through continued quarterly 6(a)(2)
Moving forward, registrants may request a further change to the conditions of registration to remove
the two-year expiration when templates are successfully used. Use of the templates will become a
condition of registration. This procedural change will support the objectives of pet spot-on mitigation
by ensuring that consistent, high quality, and useful data are received in a timely fashion, while
reducing regulatory burden. EPA will continue to actively manage these registrations by reviewing
labels for mitigation whenever registrant-requested amendments are submitted and periodically
through Registration Review. EPA may still initiate action at any time to address concerns if
unreasonable adverse effects are identified. Such actions can range from mandatory label changes to
cancellation of the registration.
Registrants can request to change the condition of quarterly submission of enhanced incident reporting
to an annual submission, and/or request removal of the two-year registration expiration date, by
submitting the following to the appropriate Product Manager for the product:
1.	Submit a current (e.g., quarterly) report using the EPA enhanced reporting templates for
incident and sales data in electronic format (e.g., CD), and
2.	Submit a cover letter formally requesting that EPA amend the conditions of registration
a.	From quarterly submission of enhanced reporting to annual submission of enhanced
reporting using the templates, and/or
b.	To remove the two-year expiration date.
The cover letter should state the following:
a.	All registration numbers included in the data submission.
b.	That EPA templates have been used for the current submission of enhanced reporting.
c.	That EPA templates will be used from this point forward for subsequent submissions of
enhanced reporting.
d.	That no other changes to the registration are requested.
Registrants who have already submitted a request according to this process to switch from quarterly to
annual reporting, and who now wish to request removal of the two-year expiration date, should submit
a new cover letter to this effect.

Once a request has been received, EPA will verify that the submission has been made using the provided
templates, and that the templates have been utilized as intended. If removal of the two-year expiration
date is requested, EPA will review the registration materials (e.g., product label and CSF) and will notify the
registrant of any changes that need to be made to reflect current mitigation. Upon verification of
successful template use and resolution of any other issues, EPA can amend the conditions of registration to
reflect annual submission of enhanced reporting using the templates and/or remove the expiration date.