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E-Labels: Distribution Issues. Jim Gray North Dakota Dept of Agriculture WRPM May 16, 2007. E-Labels: Two Overlying Issues. Use of electronic labeling as part of the pesticide registration process Mostly process issues, not regulatory issues
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E-Labels: Distribution Issues Jim Gray North Dakota Dept of Agriculture WRPM May 16, 2007
E-Labels: Two Overlying Issues • Use of electronic labeling as part of the pesticide registration process • Mostly process issues, not regulatory issues • Distribution of electronic labeling to pesticide users & dealers • Includes regulatory issues
The E-Label Model • Base container with “essential” label components • URL directing users to site for downloading the rest of the labeling • Most likely the use directions • Appropriate reference language on base container to make e-label enforceable
This Isn’t Uncharted Territory… • Electronic versions of labeling are readily available on the internet • Electronic versions of supplemental labeling are widely distributed to dealers and users • Model of base container label and URL reference language will be utilized for ESPP Bulletins
Why? • Instantaneous release of label and label revisions • Eliminates multiple label versions in marketplace • Economic savings for registrants • Improved user friendliness • Increased label compliance • Increased enforceability & compliance verification
Imagine the Possibilities… • Rate calculators • Search & sort functionality • Use of video, photos, and other media • Links to relevant sites & resources • ESPP homepage • Immediate availability of other documents • MSDSs, draft Fumigation Management Plans • Q & A sections
Distribution of E-Labeling: Issues for Consideration • Section 3 of FIFRA does NOT speak to supplemental labeling • Section 3 supplemental labeling may not be enforceable if it is not referenced on full product label • Section 3 supplemental labeling may not exist in a regulatory sense
Distribution of E-Labeling: Issues for Consideration • Is downloading or emailing e-labeling considered pesticide production? According to 40 CFR 167.3: “Produce means to manufacture, prepare, propagate, compound, or process any pesticide, including any pesticide produced pursuant to section 5 of the Act, any active ingredient or device, or to package, repackage, label, relabel, or otherwise change the container of any pesticide or device. “
Distribution of E-Labeling: Issues for Consideration • Can a pesticide user simply follow supplemental labeling on a computer screen, or do they need a hard copy? How do you prove this?
Distribution of E-Labeling: Issues for Consideration • Conflict with some state statutes • Technical abilities & capabilities of the regulated community
Distribution of E-Labeling: Issues for Consideration Where will the e-labels be posted? • EPA homepage? • Registrant homepage? • Independent third party? Note: Don’t confuse the proposed e-label repository with a distribution mechanism
E-Label Benefits Deserve Some Serious Consideration • Timely access to the most current label • More user-friendly labeling • Better communication on how to legally & safely use the product • INCREASED COMPLIANCE • Better tracking of who is reading & accessing labeling
SFIREG WC/POM E-Label Task Force Co-Chairs: Steve Foss (WA) & Regina Sarracino (CA) Other members: S. Jackling (NY), C. Mason (NV), C. Giguere (VT), J. Gray (ND), EPA/OPP, EPA/OECA, Registrants