Templates for Use in Developing Pesticide Study Documents
Current as of October 2012
As part of a cooperative NAFTA project, EPA’s Office of Pesticide Programs (OPP) and the Canadian Pest Management Regulatory Agency (PMRA) developed standard data evaluation formats, or templates. The templates have been in use by these agencies since 2002 for writing their data evaluation records (DERs) of studies submitted under the U.S. data requirements for pesticide registration (40 CFR, Part 158) and the Canadian data codes (DACOs). The DER that the agencies prepare contains a study profile documenting basic study information such as materials, methods, results, applicant’s conclusions and the evaluator's conclusions.
The templates included here and posted on the PMRA Web site provide pesticide registrants and the public an opportunity to gain a better understanding of the regulatory science review and decision-making process. The agencies encourage registrants to include study profiles based on these templates in their study documents for all pesticide types.
OPP and PMRA are committed to the use of sound science and to improving work efficiencies while making independent regulatory decisions regarding pesticide registration, re-registration, and residue tolerances. OPP believes the approaches described here for data submission and review are compatible with these commitments. As OPP and PMRA make improvements to the existing templates and/or develop additional templates for other types of studies, these new or revised templates will be added to the Web sites in both countries
Advantages of using templates
OPP and PMRA have found that the use of these templates results in increased review quality, efficiency, and transparency. The agencies believe that access to these templates provides applicants with important information regarding the specific data elements for each study and identifies key components used by OPP and PMRA to evaluate the suitability of a study for regulatory purposes.
These templates describe the layout and scope of information that should be contained within a study profile and can serve as guides for preparation of study documents. Use of the templates improves the likelihood of a successful submission, since the information necessary for an efficient agency review is outlined.
Receipt of one or more studies formatted based on these templates will enable our scientists to focus their attention on data evaluation. The review will require fewer resources, facilitating faster creation of decision documents.
Using the templates
For new studies, OPP and PMRA encourage study directors to base the core of their study documents on these templates. Applicants can add information beyond that prescribed in a particular study profile, such as country-specific data, and to meet the needs of a given chemical or specific study design. These additions should be done in such a way that the general format and content of the template does not change.
Both agencies acknowledge that this interim process will result in redundancy of information between the study profile and study document, but believe that the resulting efficiency gains are worth the effort. Once the templates become a standard for document generation, this transitional process will become obsolete.
Electronic submissions are encouraged
OPP further encourages registrants to submit these documents (completed study profile and supporting data) in electronic format (PDF) whether for the submission of one or many studies. See electronic data submissions for additonal infomation. This also applies to registrants who wish to submit applications in the OECD dossier format.