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, https://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

Looks like EPA needs an eco risk assessment, but probably does not need new data.
If conditionally required data are in and were screened, EPA does not need a new risk assessment. The lower tier assessment was okay. [EPA responded: We don’t have a lower tier eco assessment.]
EPA probably needs a plant Endangered Species assessment.
After 20 years (since the last assessment), EPA would need a new eco risk assessment. What did the screen of the avian reproduction study show? [EPA responded: OPP did not review new studies during the feasibility study.]

Human Health Risk Assessment

The human health assessment is okay, but maybe EPA needs an occupational risk assessment (RA). Was this one done before PHED (exposure database for occupational risk assessment)? [EPA responded: The occupational RA addressed chronic exposures, but not short term exposures.]
EPA doesn’t need a new occupational RA (because there were not acute toxicity endpoints that would otherwise trigger an assessment of short-term exposures).
Were there any use or other changes that would change the existing occupational exposure?
A literature search might alter the decision.

Workgroup’s Conclusions

EPA would need to do an eco risk assessment.
Also an occupational risk assessment? ... They think not.

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.

Please explain how the trap works. Does the insect remain in the trap, and is it unable to leave? [EPA responded: Yes.]
If the pesticide was toxic to the target pest, would EPA require an ecological risk assessment? [EPA responded: Yes.]

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.

Are there outstanding DCIs? [DS – The DCI data are in.]
Did mitigation reduce exposure? [JH/DS – Engineering controls and other mitigation measures required in the RED would reduce exposure to acceptable levels. These measures were adopted.]

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

EPA clarified that human exposure could result from residues on dishes.
To assess this type of exposure, EPA would use FDA methods for evaluating exposure.
To quantify this exposure, EPA can make assumptions using an FDA approach, but additional exposure data are helpful.

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.

Comment – These discharges are regulated under the Clean Water Act. They are point source discharges.
DS – EPA had to take the labels at face value. This shows the need to consult with stakeholders regarding actual uses. It highlights the importance of knowing up front what uses are being supported, and consulting with registrants to clarify vague uses on labels.
Comment – Agreement that better definition of uses is needed. Glossary of terms would be helpful and should be developed; this is something that interested parties could start developing now. Industrial users define terms differently.

Human Health Risk Assessment

Reprise of discussion regarding data needs arising from dual regulation of sanitizers under FFDCA 409 and 408.
What endpoints were used in the residential risk assessment? [DS – There are acute and chronic endpoints, and effects from chronic exposure.]
What about inerts? [DS – We also consider inert exposures in our assessments, in assessing aggregate exposure and risk.]
EPA must work smartly. Where there are multiple uses, consider where is the potential for exposure. Identify the uses that will drive the exposure assessment.
JH – If 95% of exposure is from swimming pool use and the rest is from cleaning supplies, we need to consider the odds of co-exposure.
DS – Our resources are limited, too. EPA doesn’t want to waste resources looking at insignificant use patterns and exposures.
Jay Ellenberger – Public input will help.
Comment – It would be a good idea to get people together to consider current uses.
DS – The chemical isn’t volatile; residential exposure is via the dermal route.
Q – Doesn’t EPA use a very high estimate of dermal exposure for detergent or textile uses?
DS – Agrees that dermal exposure from use as a laundry detergent is likely to be greater than exposure from use as a matrix preservative in textiles. We look for uses that are likely to drive a risk assessment or present the worst case exposure.

Ecological Risk Assessment

Need to get clarification on industrial wastewater use.
What about discharge into septic systems or residential discharges directly into the environment? [JH – We don’t assess this.]
What about the degradate (i.e., the environmentally persistent degradate of the active ingredient)? Consult with the Office of Water re: the need for a risk assessment on the degradate. Don’t use agricultural chemical default. This is a point source discharge.
There are potential non-point source discharges into surface water.

Response to Presentation of EPA’s Conclusions on Antimicrobial Case

Jay Ellenberger – Under the recommended registration review process, EPA would have consultation before we do analysis.
Workgroup members agreed with this approach, and with EPA getting use and usage data early.
Workgroup recognized the need for a glossary; we could start developing that now.
Will EPA do tolerance reassessments of the 409 uses during reregistration? [JH – 409's with no 408's will be done in registration review or in the next new uses application.]

Discussion of Aggregate Findings – Susan Lewis (SL)

Considering the three case studies, workgroup members indicated that they were not surprised to see the aggregate findings of the feasibility study.
Is EPA planning more scoping work? [SL – Feasibility study covers 10% of the cases that are likely to be done in the first five years of registration review. Other cases might turn out differently. But 10% is a reasonable sample.]
It would be useful for EPA to provide an explanation re: what we mean by “the data is adequate,” or not.
Therese Murtagh – Discussions between EPA and USDA should begin re: data needs (particularly eco) and how USDA could help fill them. This will help focus their data generation activity.
Eco Risk Assessment – If EPA hasn’t done a new risk assessment yet, how do you know that you don’t need new data?
SL – We have data to conduct a new risk assessment – using new risk assessment method. The new risk assessment may show that more data are needed. Another question is, when data needs are apparent (can’t do new risk assessment without them), how do we get the data before registration review?
Comment – Maybe through a generic DCI?
Q – Is any particular type of data missing? [EPA – No.]

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.

Will the sequence be, EPA requires data; then does risk assessment? If so, this may change the outcome.
Goes back to the question, when does EPA require new data? Will the Agency have time to review it?
EPA could conclude registration review and require confirmatory data.
SL – Yes, but data needs on the table in the feasibility study are not confirmatory – how should EPA get the data needed in time to keep reviews running?
Should EPA have a “proposed” registration review two years in advance and require the data then?
Jay Ellenberger – We don’t want to get stuck during the registration review without the data needed.
That’s why proposing the review two years in advance would be good.

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

Data; and do consultations regarding use/usage in advance.
Don’t go to a “registrant only” discussion phase in the years before registration review starts. Include the public throughout the process.
SL – This should be no problem; EPA has found consultations with stakeholders in advance to be valuable.
Do a literature search way in advance to determine where we still have data needs.
See what types of studies typically are needed and how long they take to complete.
Determine: has any of the data we need now already been requested by DCIs but has not yet been received? Will any of the data be in by the time registration review starts?

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

A document that provides a heads up – here’s what’s missing for the review coming up in X years. A DCI would also be needed.
SL – EPA envisions a Docket including the last RED/decision document, uses, labels, etc.
Would consultation begin pre- or post-DCI?
SL – EPA would have the SMART meeting equivalent early on; to begin consultation, and start get information/data that’s out there, before issuing a DCI.
EPA should document commitments made at SMART meetings so we build on them, and make results part of the Docket.
How often does EPA have SMART meetings and how are they announced?
Rich Dumas – Now they are fairly narrowly defined. The object is to get use/usage information.
Build SMART meetings that are open to the public into the registration review process.

Vivian Prunier summarized the process:

list all pesticides in order coming up
schedule – announce every two years for pesticides coming two years down the road
SMART meetings – have two years in advance of review

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

Data needs and how to address them (timing and process) –
Julie Spagnoli, Sue Crescenzi, Ray McAllister
Public participation/stakeholder involvement –
Eric Olson, George Wichterman

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

What should the registration review decision document look like? Format, content?
What shall we do with individual products in registration review?
Electronic label review – possible? Searchable?
Public health pesticides
Inerts – those with food uses are subject to tolerance reassessment. If no food uses, then what? How will we ensure that non-food-use inerts part of registration review gets done?

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September 28, 2004 Minutes - PPDC Registration Review Workgroup Meeting

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