Submission Pitfalls of Biopesticide Applications at U.S. EPA - BPPD
Biopesticides and Pollution Prevention Division (BPPD)
| EPA File Symbol/Reg. No.: _____________ | Application Date: ________ |
| RAL: ________________________ | Fast Track  |
1. Application Form (EPA Form 8570-1) -signed & complete including package type. YES NO
| If NO, STOP! Call applicant and have them correct application and resubmit. |
2. Amendment covered by PR Notice 98-10 (Notifications)? YES NO
| If YES, STOP. Call applicant and give them the option of withdrawing this amendment and submitting a notification. If they withdraw amendment, close out PRATS. |
3. Final printed labeling received for previous action? YES NO
| If NO, Stop! E-mail applicant and request final printed labeling (FPL). Let them know that FPL from the last accepted label is needed to support the current application. File copy of your e-mail as record of notification. Log out of PRATS (label deficiency). Exceptions to this practice can occur. |
4. Confidential Statement of Formula (CSF) EPA Form 8570-4 Basic Formula Alternate Formula
| a) | Label(s) Expedited CSF Review completed? YES NO |
| If, so, SKIP to next item. |
| b) | CSF is signed and dated? YES NO |
| If NO, call applicant. |
| c) | Completely filled out: CAS numbers, pH, flashpoint, flammability, if applicable? YES NO |
| d) | Are the totals accurate? YES NO |
| e) | Certified limits agree with 40 CFR 158.175 or 5 batch analysis? YES NO |
| f) | Viability (if live microbial, e.i., cfu/gram)? YES NO NA |
| g) | PC codes assigned on CSF for actives & inerts plus 40 CFR 180.1001 c, d, or e codes noted for products that have food or feed uses? YES NO |
| h) | No List 1 inert ingredient(s) present in the formulation? YES NO |
| i) | Alternate formula(s) do not require different labeling from basic formula or other alternate formulas? YES NO NA |
| j) | Source for a.i. is a registered pesticide? YES NO |
5. Data and Data Matrix (EPA Form 8570-35)
| a) | Using Selective Method? YES NO |
| If NO, (Data Matrix not required), skip to Item 6. |
| 1) | Complete Data Matrix. Minimum Data Matrix for registration includes: Product specific acute tox and product chemistry data, plus Efficacy data for Public Health pests claimed on label. YES NO |
| b) | There is adequate Product Specific data? YES NO |
| c) | Registered source used for active ingredient? YES NO |
| If Yes, active ingredient is from a registered source and generic data should be satisfied by registered source. Skip to Item 5. If No, generic data is necessary. |
| d) | Data passed 86-5? (Data formatting PR Notice) YES NO |
| e) | Public copy of Matrix provided? (As required by PRN 98-5) YES NO |
6. Certification with Respect to Citation of Data (EPA Form 8570-34) See 40 CFR 152.80-98 and PR Notice 98-5 [Note: If no data are required or submitted, a Certification with Respect to Citation of Data form is not needed. This is often true for minor amendments.]
| a) | Did applicant check a Method of Support? YES NO |
| b) | General Offer to Pay checked for Cite-all Method or Cite-all under Selective Method? YES NO |
| c) | Is the form signed and dated? YES NO |
| d) | Check form and Data Matrix; are Exclusive Use data cited from other sources? YES NO |
| 1) | If Yes, is the required authorization letter included in application? YES NO |
7. Formulators Exemption (EPA Form 5870-27)
| a) | If registrant is using a registered source active ingredient in the formulation, is form filled out completely and signed? YES NO NA |
8. Science Review Completed? YES NO