Steve L. Foss Washington State Dept. of Agriculture Victoria Cassens Purdue University

1. E-Label: Registration, Label Identifiers & NPIRS Pilot Project Steve L. FossWashington State Dept. of Agriculture Victoria Cassens Purdue University

2. eLabel State Registration Issues SLAs are receiving a greater number of labels in electronic PDF format. Label exchange methods with states CD, email, or upload Email / elabel issues elabel repositories Version/date code or label identifiers

3. Exchanging Elabels with State Registration Programs ~ 20 states (~39%) accept Elabels on CD AL, AZ, AR, CT, IL, LA, MD, MN, MO*, MT, ND, OH, PA, RI, SD, TN, UT, VT, WI, WY ~14 states (~27%) accept Elabels via email AZ, GA, HI, LA, MN, MO*, MS, ND, NV, OK, SC, SD, UT, VT * Require elabels be submitted in PDF format. Source: RegWest Company LLC

4. Exchange of eLabels:Submission via Email Issues

5. Exchange of eLabels:Submission via Email Issues Need to be able to print a legible eLabel (corrupted file?) eLabel acceptable for viewing

6. eLabel Repositories: CDMS

7. Repositories: Kelly Registration Systems (KRS) Submit Pesticide Documentation On Line

8. Repositories: SLN / Sec. 18 labeling on WSU’s website WSDA started exchanging electronic copies of SLN labels in early 1997 to improve services. Advantage:Quicker turnaround timecompared to handling and marking up paper copies and sending documents back/forth to registrants.

9. Approved Label State Tracking and Repository (ALSTAR) system by NPIRS

10. Use of Repositories:Exchange of elabels with Educators & Applicators/Growers CLA’s Vision of the e-Label Process • Applicators could obtain supplemental site specific use instructions provided by dealer or via the internet (recognized site): • Single-crop use instructions • Registrant ships product with basic labeling information that rarely changes • Product Name, Ingredient, EPA Reg. Number. Ray McAllister, CropLife America – NPIRS Elabeling Forum

11. Linking elabels to Keep Recommendations Up-to-Date Chateau (Flumioxazin)

12. Types of Identifiers Registrant Generated number / date code System Generated Document ID Standard Label Version Identifier (VIN) Mathematically Calculated Global Unique IDentifier (GUID)

13. eLabel State Registration Issue: Identifiers WSDA Registration Specialists will look for company identifiers on labels and enter this code into our state pesticide registration database (if we can find it!) ~ 17% of the 11,200+ labels reviewed have no unique label identifier. SFIREG has recommended to EPA’s Label Review Committee that a “standardized label version code needs to be developed that will identify a specific label by brand name and whether it’s the latest version.

14. Type 1:Registrant Generated Identifier Many label ID’s are non-standarddates or include a date

15. Type 1: Registrant Generated Codes appear in various areas on a label, but are usually found on the front or last page of product labeling. Label Id = SCP 817A-L1M 1104

16. Type 1: Registrant Generated • Some labels may multiple identifiers or “Part Numbers” on each label component: • Back Label: LB09952H011 • Front label: LB099699010

17. Type 1: Registrant Generated The identifier used by many registrants might not be ‘unique' for the purpose of document management and exchange with state agencies. However, registrant generated codes (e.g. revision dates) on certain types of labels, such as SLN’s, may be adequate because the SLN number is unique to the state label unlike section 3 products, which may have multiple brand names using the same EPA Reg. Number.

18. Type 2: System Generated Document ID Used by New York State to index/id scanned label images Document ID = 503307

19. Type 2: System Generated Document ID Same label registered in Hawaii has a different Document ID Document ID = 9226.249

20. Type 2: System Generated Numerical Identifier Strengths: Unique, Standard, Useable Weakness: The same label is stored in NPIRS under two different Product ID Numbers: NY (503307) HI (9226249)

21. Type 3:Standard Label Version Identifier (VIN) A structured VIN or GUID (Global Unique Identifier) could be based upon EPA’s Specification for Text PDF Product Labels and used as the file name for the label in PDF format.

22. Type 3:Standard Label Version Identifier (VIN) Product Trade NameEPA Reg. No. Version Bicep II Magnum  100-817 01 Bicep II Magnum FC Herbicide 100-817 02 DuPont Cinch ATZ Herbicide    100-817-352 01 <000100 00817 000352><20021002> <dl> <01> <EPANo><Verdate><type><verbrand>

23. Type 3: Printing VIN / GUID on Labels The GUID could be printed on labels to facilitate the linking of labels to state registration data. EPA Reg. No.Verdate VIN / GUID = 8033-23-82695 (051205-1529)

24. Type 4: Mathematically Calculated GUID Identifier GUID (Globally Unique Identifier) Pseudo-random 128-bit values that is statistically likely to be different from any other generated code using freely available software programs. Unique across both, space and time. Consists of five groups of hexadecimal digits. 8 digits 4 4 4 12 digits Example: 6B29FC40-CA47-1067-B31D-00DD010662DA

25. Type 4: GUID Identifier is the DocumentID or Metadata in PDF (Select Document Properties / Description / Advanced) GUID - UUID

26. Type 4: GUID Identifier’s are XML tags CLA’s Vision for e-Label Process (Ray McAllister, NPIRS Elabel Forum) Registrant prepares labels in standardized electronic format. • XML fields define information content. • PDF defines appearance of label. Structured Product Labeling (SPL) is a standard adopted by FDA XML details: The identifying information is in the form: <id root="6B29FC40-CA47-067-B31D-00DD010662DA"/> The <id root> is a GUID for the specific document SPL instance and will differ for every regulatory submission.

27. ALSTAR- Vicki Cassens, NPIRS