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September 28, 2004 Minutes - PPDC Registration Review Workgroup Meeting

Presentation slides and other background information is available on EPA’s PPDC Registration Review Workgroup webpage, http://www.epa.gov/, and in docket # OPP-2004-0014.

PPDC Workgroup Members:

Cindy Baker, Gowan (by phone)
Patti Bright
Sue Crescenzi
Ted Head
Steve Kellner
Ray McAllister
Therese Murtagh
Eric Olson
Peg Perrault (by phone)
Julie Spagnoli
George Wichterman

Other Public Participants:

Richard Conn, Charles and Conn, LLC
John Cummyje (?), DuPont
Michael Culy, Dow AgroSciences
Betsy Heger, Keller and Heckman
Nancy Lomax, DuPont
Sean McNear, Troy Corporation
Eileen Moyer, Reckitt Benckiser (?)
Claudia Olivierri, BASF (by phone)
Diane Schute, CPDA
Laura Sears, BASF
Kathie Tryson, United Industries
John Worgan, Health Canada
Phil Zahodiakin, Pesticide Insider

EPA Work Group Members and Presenters:

Jim Jones
Jay Ellenberger
Susan Lewis
Vivian Prunier
Richard Dumas
Linda Hollis
Jack Housenger
Debbie Smegal
Ray Kent
Dana Spatz
Phil Ross
David Stangel
Carol Stangel
Istanbul (Isty)Yusuf

Welcome – Jim Jones, Director, OPP

While earlier PPDC Registration Review Workgroup meetings explored the principles of registration review, the purpose of this meeting is to go from the abstract to the specific, and show “illustrative results” – how EPA’s Office of Pesticide Programs (OPP) could apply those principles to three sample pesticides (a conventional chemical, a biochemical, and an antimicrobial) going through registration review. Note that the examples presented are “illustrative” only; the program is still a work in progress. OPP requests the Workgroup’s feedback – what are the strengths of this approach, and what else can/should the Agency do? It only works if all are ready to participate, and give meaningful input. OPP is seeking consensus, but consensus is not a required outcome. A constructive discussion of the issues, even without consensus, will be helpful. We are willing to go beyond this meeting and continue discussions, to a point – however, the rule and program must be in place by August 4, 2006.

Registration Review Rule Development – Vivian Prunier

Question (Q) – Triggering event?
EPA – The schedule is based chronologically on the date of the original registration or the RED signature, whichever is later.

Comment – During registration review, a list of Data Call-Ins (DCIs) issued or a system for tracking DCIs should be publically available so both registrants and the public can determine what data have been requested and which studies are still outstanding.
EPA – While OPP does not have a blanket system publically available for this purpose at present, it is possible to generate reports on DCI status.

Regulatory and Science Changes Since 1984 – Richard Dumas

No comments on presentation.

Endangered Species Act and Endocrine Disruptors – Jay Ellenberger

Comment – Registration review should not be used to obtain data to satisfy new requirements; OPP should use DCIs for that. Because of resource constraints, however, the Workgroup understands that OPP must balance special DCIs with routine registration review.

EPA will not delay the final registration review rule until the Agency obtains Endocrine Disruptor data.

EPA will release the registration review procedural rule separately from the revised Part 158 rule, though the two events may coincide.

Introduction to Feasibility Study – Susan Lewis

Q – How did OPP handle inert ingredients?
EPA – One case in the feasibility study had a chemical with inert ingredient uses as well as active ingredient uses. Exposure from the inert uses was included in the analysis. The feasibility study showed the need to have procedures to account for inert ingredients.

Q – Were studies required by DCIs in?
EPA – Many studies required by DCIs had been submitted and were included. However, OPP found that we can’t easily track the status of studies required as a condition of FIFRA section 3(c)(7) registration.

Comment – FQPA requires consideration of anticipated residue data and percent crop treated data. OPP will need to be able to track changes in anticipated residues and percent crop treated.

Study on Conventional Chemical – Ray Kent and Dana Spatz

Considering the background information presented for this conventional pesticide case, workgroup members commented as follows.

Ecological Risk Assessment

Human Health Risk Assessment

Workgroup’s Conclusions

Response to Presentation of EPA’s Conclusions on Conventional Case

Q – Who maintains human health incident data?
EPA – FIFRA 6(a)(2) information reporting requirements include incident data; the NPIC hotline is available for questions and incident reporting; poison control centers maintain data (EPA buys their data); and California maintains incident reporting data.

Q – Would EPA anticipate a change (in regulatory position) for this chemical?
EPA – The Agency didn’t do a new risk assessment so we don’t know.

Q – Is registration review the trigger for an ESA review and determination? Can EPA make a registration review decision without an ESA assessment?
EPA – An ESA decision, unless completed before the registration review, would be made during registration review. EPA will always seek effect information (as required in the counterpart rule). The Agency can make a “no effects” determination or require mitigation until a “no effects” determination can be made. No need to consult (with the Department of Interior) if there is a “no effects” determination.

Study on Biopesticide – Linda Hollis

Workgroup’s Comments

Considering the background information presented for this biopesticide case, workgroup members commented as follows.

Workgroup’s and EPA’s Conclusion

The workgroup concluded that this case qualified as an “easy off” decision. Linda Hollis confirmed that this was EPA’s conclusion, as well.

Background on Antimicrobial Pesticides – Jack Housenger (JH)

Q - What about something that is a direct food additive (i.e., FDA has sole jurisdiction) and a pesticide?
JH – When making an FFDCA 408 determination on the indirect food uses of the pesticide (for which EPA and FDA share jurisdiction), we would include exposure from direct food use in the aggregate risk assessment.

Q – What if most of the exposure comes from non-FIFRA use? Does EPA always consider FDA uses?
JH – Yes, if we know about them.
Comment – EPA didn’t include lice shampoo exposure (a human drug/pharmaceutical use regulated by FDA) when the Agency completed the Lindane RED.
Comment – FDA modified the lice shampoo regulation based on the EPA RED.

Q – Regarding data supporting FDA’s decisions on pesticides used for indirect food use (i.e., under FFDCA section 409), FDA’s data requirements are driven by estimated exposure. FDA approvals are based on years of experience and data. FDA uses conservative exposure models. There is a controversy in the antimicrobial industry over what should drive data requirements – exposure or the FFDCA 408 standard?
JH – We agree that we are looking at a low percent of the CPAD.

Study on Antimicrobial Pesticide – Debbie Smegal (DS)
[A pre-FQPA RED]

Workgroup’s Comments

Considering the background information presented for this antimicrobial pesticide case, workgroup members commented as follows.

Discussion focused on use of the pesticide as an active ingredient in dishwashing detergents.

Several questions followed regarding the industrial wastewater treatment use and other uses that appear to be outdoor uses, triggering the need for environmental fate data and ecological risk assessment.

Human Health Risk Assessment

Ecological Risk Assessment

Response to Presentation of EPA’s Conclusions on Antimicrobial Case

Discussion of Aggregate Findings – Susan Lewis (SL)

Plan Presentation to Full PPDC Meeting in October – Jay Ellenberger

Workgroup commended EPA for doing the feasibility study. They understand why (in the interest of time) the study didn’t include a public process, or solicitation of use/usage information. Those things will be added to the final process.

Data needs were then discussed.

The group discussed what information should go into the Docket in advance.

The group discussed what sort of document/documentation they envision starting the registration review process, and the role of SMART meetings.

Vivian Prunier summarized the process:

Based on this discussion, draft presentations for the PPDC meeting will be developed as follows:

The Workgroup decided to meet on October 15, 2004 to compare draft presentations and prepare final ones for the full PPDC meeting on October 21, 2004.

Discussion of Future Projects – Jay Ellenberger and Vivian Prunier

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