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

Checklists

Internal BBPD Guidance Document - Other Items May be Required

EPA File Symbol/Reg. No. of product reviewed: _____________

Application Date: _____________

If amendment, indicate type: label, CSF or both: _____________

If amendment, is change 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 PRATS, forward to NRC.

1. Application Form (EPA Form 8570-1) signed and complete      YES        NO

         including package type

1a.	Fast-Track:      YES        NO

2. Final printed labeling received for labels approved after 10/1/99?      YES        NO         NA

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.

3. Confidential Statement of Formula (EPA Form 8570-4)

a)	Completely filled out including pH, flashpoint, flammability, etc. if applicable      YES        NO
b)	Totals are accurate      YES        NO
c)	Certified limits agree with 40 CFR 158.175 or 5 batch analysis      YES        NO
d)	PC codes assigned on CSF for inerts and 40 CFR 180.1001 c, d, or e codes noted for products that have food or feed uses      YES        NO
e)	List 1 inert ingredient present?      YES        NO
f)	Alternate formula(s) do not require different labeling from basic or other alternate formulas?      YES        NO
g)	CSF is signed and dated      YES        NO
h)	Registered source for a.i.      YES        NO

Internal BBPD Guidance Document - Other Items May be Required

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

a)	Using selective method?      YES        NO

If NO, data matrix not required, skip to item 5.

1)	Complete data matrix. Minimum data matrix for registration would include product specific acute toxicology and product chemistry data and efficacy for public health pests. Minor CSF and labeling amendments may not require a data matrix.      YES        NO

b)	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 needed.

1)	adequate generic data      YES        NO

d)	Data passed 86-5 (Data Formatting PR Notice)?      YES        NO
e)	Public copy of matrix present, as required by PR Notice 98-5 (Data Compensation)?      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)

If no data are required or submitted, Certification with Respect to Citation of Data need not be submitted. This is often true for minor amendments.

a)	Did applicant check a method of support?      YES
b)	General Offer to Pay checked for cite-all method      YES        NO         N/A        or cite-all option under selective method.
c)	Is the form signed and dated?      YES        NO
d)	Check form and data matrix. Are exclusive use data cited      YES        NO from other sources?

1)	If YES, is required authorization letter present?      YES        NO

6. Formulators Exemption Form (EPA Form 8570-27) filled out and signed if using a registered source active ingredient in the formulation.
     YES        NO         N/A

Internal BBPD Guidance Document - Other Items May be Required

7. Exclusive Use Notice Requirement Prior to Registration (Required per 40 CFR 152.116, separate from permission of an exclusive use data submitter to rely on exclusive use data)

Is this an exclusive use active ingredient or combination of active ingredients (registered within last 10 years) ?      YES        NO

If YES, go to a) or b) below.

a)

Has a notification letter or email been sent to the exclusive use data submitter(s) at least 30 days before registration ? (This notification is required for all methods of data support except when the exclusive use data submitter(s)' product is used to formulate and the formulator's exemption is claimed.)      YES        NO

1)	Has exclusive use data submitter requested during 30 day period the applicants' list of data requirements and method of compliance ?     YES        NO

b)	Has registrant submitted certification from exclusive use data submitter that submitter is aware of application and does not object to the registration?      YES        NO

8. Label(s) Date of Label Review:

a)	Label(s) agree with current Label Review Manual and appropriate REDS      YES        NO
b)	Acute toxicology, product chemistry, and efficacy data examined for labeling      YES        NO
c)	Nominal concentration of a.i. listed in ingredients statement      YES        NO
d)	Storage and disposal instructions agree with container types listed on application form      YES        NO
e)	Unique Product Name for Same Company (Check REFS)      YES        NO
f)	Labeling is acceptable. Corrections or changes are NOT necessary?      YES        NO