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Biopesticide Registration Inconsistency Issues
The bppdconsistency@epa.gov e-mail address has been created to respond to issues concerning Biopesticide registration inconsistency that affect processing of submissions. The Biopesticide Regulatory Action Leaders (RALs) will meet to discuss these issues and provide an answer usually within two to three weeks. Resolution of these issues will be posted to the Biopesticide website. Since this e-mail address is intended to focus only on addressing generic issues regarding consistency in the regulation of Biopesticides, other questions regarding biopesticides should be directed to the appropriate Biopesticide RAL or the Biopesticide Ombudsman, Christina Scheltema, scheltema.christina@epa.gov.
Consistency Issue No. 1 - Data Waivers and MRID Numbers
Consistency Issue No. 4 - When should an EUP label be used for shipments of commerically approved PIPs being used under an EUP?
Consistency Issue No. 5 - BPPD Processing of Gold Seal Requests
Consistency Issue No. 1 - Data Waivers
and MRID Numbers
Summary of 9/9/04 Industry Email
At present EPA recommends that when a data waiver is requested, a scientifically
sound rationale be submitted for each data requirement. Typically data
waiver rationales involve a discussion on the safety of the ingredient of the
pesticide, on the low anticipated exposure, and a review or discussion on pertinent
published literature or other regulatory approvals such as FDA GRAS listings. Our
practice is to submit a single data volume that includes a scientifically sound
waiver rationale for individual data requirements, with copies of any referenced
published literature or other citations in an appendix. The data volume
is formatted per PR Notice 86-5, so that a MRID number is assigned. The
assignment of an MRID number is particularly useful to identify how each data
requirement is fulfilled (for instance on a data matrix table). I believe
this is the preference of both the registrant and EPA.
In the past, as long as a data volume of this nature did not include the
words "waiver" in the study title, and the data volume was properly
formatted per PR Notice 86-5, a MRID number would be assigned. Recently,
however, these data volumes have NOT been assigned MRID numbers and are rather
noted as "ADMIN" on the 86-5 notice. A case of
what worked before does not work now.
I have not been able to obtain an explanation of why MRID numbers have ceased
to be assigned, but can only assume that the screeners are noting the words "waiver" either
in the submission cover letter or in the actual data volume itself. It
is my understanding that BPPD prefers to have MRID numbers assigned
to properly formatted data waiver rationale data volumes, and as a registrant
it is certainly my preference as well.
EPA Response
EPA encourages the submission of data waivers formatted to comply with PR Notice 86-5.
Previously, the policy was not to assign MRIDs to data waivers. If a volume has not been explicitly identified as a waiver request, then it may have been assigned a MRID. This is not due to any inconsistency on the part of our data management contractors. They are looking at these volumes for compliance with the data formatting guidance, not for content. It is up to the data submitter to properly label the contents of their data submissions.
In response to the bppdconsistency email and other requests, we have issued new internal guidance for PR Notice 86-5 compliance review. As part of this change, PR Notice 86-5 reviewers will:
assign MRIDs to data waivers that comply with PRN 86-5;
reject data waivers that are not in compliance with PRN 86-5 if the submitter made an attempt to comply;
neither assign MRIDs to nor reject any data waivers that are included within a compilation of administrative material or discussed in any correspondence addressed to the PM/RAL/CRM; and
not assign MRIDs to any previously-submitted waiver requests, only those included in new submissions
Consistency Issue No. 2 - Is it Necessary to Include an Application Form (
8570-1) with Resubmissions for Pending Applications?
Summary of 10/1/04 Industry Email
Oftentimes in the review process it is necessary for the registrant to submit
a revised label, revised CSF or some other response to identified deficiencies
for a pending application. Typically, such a response includes an explanatory
cover letter and the revised document(s). Further, it is typically
clear in the explanatory cover letter to which pending application the response
pertains.
Some RALs want to see a completed 8570-1 form included with each resubmission,
while others do not. In my opinion, it is not necessary as this form
is already on file with the initial application. As long as the identifying
information on the pending application is clearly found in the explanatory
cover letter (the File Symbol or Reg. No.), it seems like overkill.
What is BPPD's preference - to include or to not include the 8570-1 form
with each resubmission for a pending application?
EPA Response
If EPA sends a deficiency letter in response to an application, then the applicant response should include an application form that has "Resubmission" checked in section II of the application form. On the other hand, if while reviewing a pending application, the RAL requests information prior to or in lieu of a deficiency letter, then an additional application form is not required.
Consistency Issue No. 3 - Submission of California Department of Pesticide Regulation (CAL DPR) Data Evaluation Records (DERs)
Summary of Industry Email
For biopesticide registration applications that are submitted concurrently at EPA and at the California Department of Pesticide Regulation (DPR), it is generally true that DPR science reviews are available earlier than EPA Data Evaluation Records (DERs). (DPR issues its science evaluations as they occur during the review process, as opposed to all at once at the end of the review process.) BPPD staff have indicated that it is helpful to have DPR reviews when they are available, and that they should be submitted whenever possible. What is the most efficient and appropriate way for DPR science reviews to be submitted? Should they go through front end with an accompanying cover letter identifying which pending application they correspond to? Alternatively, should DPR reviews just be emailed as a pdf attachment to the attention of the responsible RAL?
EPA Response
Upon concurrence by the RAL to the applicant, Cal DPR reviews may be sent via email and/or through front-end processing. However, CBI containing Cal DPR reviews must only be sent in through front-end processing and have the CBI portion separated and clearly marked by the applicant. Cal DPR reviews must be accompanied with a cover letter that contains the following statement (PDF or hard copy) signed by the applicant:
“I certify that the Cal DPR review electronic file identified below by file name and/or the paper copy submitted with this certification is/are identical to the paper copies we received from the California Department of Pesticide Regulation for these documents. I certify that the statements that I have made herein are true, accurate, and complete. I acknowledge that any knowingly false or misleading statements may be punishable by fine or imprisonment or both under applicable law.”
Consistency Issue No. 4 - When should an EUP label be used for shipments of commerically approved PIPs being used under an EUP?
Summary of Industry Issue
When should an EUP label be used for shipments of commerically approved PIPs being used under an EUP?
EPA Response
Guidance on Shipments of Already Commerically Approved PIPs Being Used Under an Experimental Use Permit
Plant-Incorporated Protectants (PIPs) are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. Experimental use permits (EUPs) are issued under section 5 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the generation of information/data necessary to register a pesticide under section 3 of FIFRA. EUPs are required for testing an unregistered PIP or an unregistered use of a PIP on a cumulative total of over 10 acres. For pests that occur in different geographical situations, EUPs are required for testing PIPs on a cumulative total of over 10 acres per pest.
The guidance below regards what EUP labeling is required for shipments of commerically approved PIPs being used under an EUP.
For any plant-incorporated protectant (PIP) EUPs where PIPs that are registered are being used in the EUP to stack with an experimental PIP (or perform some other use not approved under the registration), the shipment of the registered PIP for the EUP requires the following:
1) Once the EUP has issued, if all the seed of the registered PIP being shipped are for use in the EUP, then the EUP label must accompany that shipment. This label must comply with the EUP labeling requirements found at 40 CFR 172.6(a) and will include the language "For Experimental Use Only."
2) Once the EUP has issued, to the extent that any portion of a registered PIP being shipped ultimately is used in the EUP, a supplemental EUP label is required. This label will need to be approved by EPA pursuant to the EUP labeling requirements found at 40 CFR 172.6(b) and will not include the language 'For Experimental Use Only."
Consistency Issue No. 5 - BPPD Processing of Gold Seal Requests
Summary of Industry Email
From industry experience, registrants have found that the time it takes to obtain gold seal certificates varies between the two BPPD branches and takes longer than experienced for RD products.
From Industry's perspective, this appears to be a fairly routine action. We wonder why there is such a time delay for these actions and whether there is anything the registrants can do to help speed up the process. For example, if the registrant includes a copy of the last stamped approved label on file at EPA will that allow for quicker processing (so that the EPA person does not have to retrieve the file jacket)?
BPPD Response
BPPD has taken steps to speed up our review of gold seal certification letter requests. Procedurally, BPPD pulls the registration jackets and verifies that the registrant has complied with previous requirements, such as submitting final printed labels, before sending out the gold seal certification letter.
BPPD advises registrants to make sure that the previous action required --
such as submitting final printed labels—has been complied with. Supplying
copies of the last acceptable label also helps, as it saves us copying them
to attach to the letters. However, BPPD will still check the registration jackets
to verify that the label copy matches the one in Agency files. Gold seal certification
letter requests to BPPD need to be in writing.