Submission Pitfalls of Biopesticide Applications at U.S. EPA - BPPD

EPA Reg. No.: _____________

Application Date: ________

RAL: ________________________

Internal BBPD Guidance Document - Other Items May be Required

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.

1a	Fast-Track?      YES        NO

2. Amendment covered by PR Notice 98-10 (Notifications)?      YES        NO

If YES, STOP! Call applicant and inform them that this submission will be converted to a notification. After closing out in PRATS, forward to Notification Review Coordinator.

3. Final printed labeling received for previous action?      YES        NO

If NO, Stop! E-mail applicant and request final printed labeling (FPL). Inform them that FPL from the last accepted label is needed to support the current application. File e-mail as record of notification. Log out of PRATS (label deficiency).

4. Data and Data Matrix (EPA Form 8570-35)

a)	Using Selective Method? [If NO, (Data Matrix not required), skip to Item 5.]      YES        NO

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)	Adequate Product Specific data      YES        NO
c)	Registered source used for active ingredient? If Yes, active ingredient is from a registered source and generic data should be satisfied by registered source. Skip to Item. If No, generic data is necessary.      YES        NO
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

5. 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

6. Label(s) Review Date of Label Review:

a)	Label(s) agrees with current Label Review Manual and appropriate REDS      YES        NO
b)	Labeling from acute tox, product chemistry, and efficacy data (Public Health pests)      YES        NO
c)	Nominal concentration of active ingredient shown in ingredients statement      YES        NO
d)	Viability included as substatement of Ingredient Statement (if live microbial, e.i., cfu/gram)     YES        NO
e)	Storage and disposal instructions agree with container types listed on application form      YES        NO
f)	Unique Product Name for Same Company (Check REFS)      YES        NO
g)	Labeling is acceptable. Corrections or changes are NOT necessary.      YES        NO

Internal BBPD Guidance Document - Other Items May be Required