Notes from 2,4

- D Registration Review Focus Meeting 7/17/12 ; 1

- 3 pm, PY South, S9100

Agenda and attendance sign

- in sheet s attached.

Introductions were made. The Agency welcomed the visitors and thanked them for their willingness to participate. The Task Force thanked the Agency for the opportunity to participate.

P urpose of the meeting

— EPA explained that

The 2,4

- D registration review team is currently reviewing past assessments of 2,4

- D, determining the appropriate scope for new assessments, and identifying data needed to conduct those assessments. The team had a number of questions relating to the usage of 2,4

- D and application parameters on product labels, the answers to which will hel p inform the scope and data needs decisions. The team also wanted to share its thoughts on areas where risk management and product stewardship were likely to be needed.

The schedule for the registration review of 2,4

- D also was discussed. Milestones f rom the schedule were included in the meeting a genda attached to these notes )

. EPA also explained that data gaps and labeling deficiencies add uncertainty to the assessment of risks and benefits, which typically obliges the Agency to make conservative ass umptions in order to avoid underestimating risks. Thus, it is to the registrants’ advantage to clarify use parameters and provide other information that will inform the risk assessments.

The Agency will try as best it can to review 2,4

- D data currently i n house in order to account for that information in its registration review work plan for 2,4

- D and subsequent assessments.

Information exchange

—
The Task Force provided background information on data submissions currently under review with the Agency. The Task Force asked about the use of EDSP data submitted for 2,4

- D. EFED team members indic ated that apical endpoints from the fish and amphibian studies might be relevant for their purposes.

The team had provided a list of questions for the Task Force, concentrating on regional usage and use parameters not articulated on product labels. The Task Force indicated that it would try to provide the requested information. Since the requested usage information is very detailed and not easily obtained, the Tas k Force asked what was most useful. BEAD specifically mentioned information on non

- agricultural sites and percent

- crop

- treated data. Others on the team highlighted the need for information on specialty (“boutique”) uses. The information requested to fil l in blanks on use parameters is very specific and was not discussed in detail at the time of the meeting. BEAD also had some new comments on the master label spreadsheet. The Task Force was asked to respond to those comments and address the missing use parameters within two weeks of the meeting.The team asked the Task Force to consider the possibilities for implementing PR Notice 2001

- 5

on labeling for pesticide resistance management, for anticipating ways to mitigate risks to endangered species, and f or managing drift. BEAD noted that the PR Notice will be updated in the near future.

The team asked for refinements to the citations for 2,4

- D data submitted to the Agency , but subsequently withdrew the request when the Task Force explained the citations were in spreadsheet form and could be sorted to respond the Agency’s needs.

Feedback

---
The Task Force thought the Focus Meeting concept was helpful. The team is hoping that after reflection, the Task Force might be able to convey thoughts on what worked for the industry, and how the focus meeting might be made more effective from its perspective

. Next Steps

EPA will continue work on the Registration Review Preliminary Work Plan, which is scheduled to be completed and made available for public comment at the end of December 2012.

AttachmentsAgenda for 2,4

- D Focus Meeting 7/17/12

1

- 3 pm, PY South, S9100

Times are approximate; we can use them to make sure we leave time to cover all agenda items.

From 1 pm until approximately 1:30 p m

Introductions (see Attachment 1

— Invitees)

-- All Welcome from EPA; purpose of the meeting

-- EPA Process and schedule for registration review (Attachment 2

— Schedule)

-- EPA General impact of label and data gaps on assessment

— EPA General comments on use of data not previously reviewed (Attachment 3 )

-- All Data in development, planned, or not previously submitted

— Task Force

From around 1:30 pm until approximately 2 : 50 pm

Information exchange

— Team questions (see Attachment 4; note: some Qs already covered)

— All Remaining issues with Master Label spreadsheet

— (see Attachment 5 and BEAD comments on spreadsheet; Task Force may not be able to respond today) Endangered species assessments; looking forward to risk management

-- All Linking MRIDs to active ingredients and guideline numbers

-- EPA

Until 3 pm

Focus Meeting process; thoughts on what works and how we can further our common goals

-- All Next steps

— EPA

o Will docket meeting notes within 10 days (courtesy copy to registrants)

o EPA goes back to work on Problem Formulation and Scoping DocumentAttachment 1

– List of Invitees to 2,4

- D Focus Meeting

Biological and Economic Analysis Division Arnet Jones Bill Chism Bill Phillips Derek Berwald Diann Sims Sepehr Haddad Steve Jarboe Timothy Kiely

E nvironmental Fate and Effects Division Edward Odenkirchen Faruque Khan Nancy Andrews Sujatha Sankula Meghan Radtke

Health Effects Division Jeff Dawson Linda Taylor Michael Metzger

Pesticide Re

- evaluation Division Cathryn Britton Jill Bloom

Registration Division Dan Kenny Kathryn Montague

Non

- team Members (all PRD) Catherine Eiden Michael Goodis Richard Dumas5

USDA, Office of Pest Management Policy Sheryl Kunickis, Director

The 2,4

- D Industry Task Force II on 2,4

- D Research Data Larry Hammond ; Chairman, Technical Committee Bill Mahlburg ; Nufarm Americas, Inc. Diego Fonseca ; Dow AgroSciences Jim Kunstman ; PBI Gordon Corporation Jim Gray ; Executive Director, 2,4

- D Task Force Jim Armbruster ; J.Armbruster LLC, TF Consultant Debra Mil ler ; Data Group Management, TF Account6 Attachment 2

-- Prospective Schedule for 2,4

- D Registration Review

 First team meeting 5/22/12  Focus meeting 7/17/12 Docket opening December 2012 End comment period February 2013
Final Work Plan May 2013
Issue DCI approx. March 2014 *
Draft Risk Assessments 2018 Proposed Registration Review Decision 2019

* Timing after this point depends on nature of data requirements7

Attachment 3

— T ask F orce ’s list of submissions not reviewed (as of March 2012)

MRID 46487501, Ris k Assessment Refinements for 2,4

- D Uses

– Avian, Wild Mammals, Non

- Target Plants by Poletika and Kranzfelder, dated March 03, 2005.

MRID 48489901, Acute Dietary Toxicity of 2,4

- D 2

- EHE in Mice. An LDD50 ester in mice by Carolyn Lowe, dated January 13, 201 1.

MRID 48489902, Acute Dietary Toxicity of 2,4

- D DMA in Mice. An LDD50 amine in mice by Carolyn Lowe, dated January 13, 2011.

MRID 47582401, Giddings, Jeffrey M. Summary and analysis of labels for 2,4

- D products registered in California. Compliance Se rvices International. Study No. CSI08723. August 8, 2008.

MRID 47582402, Giddings, Jeffrey M. Use of 2,4

- D in locations where the California red

- legged frog has been observed. Compliance Services International. Study No. CSI08724. Sept. 3, 2008.

MRID 47602501, Giddings, Jeffrey M. Evaluation of fish and amphibian toxicity data for 2,4

- D. Compliance Services International. Study No. CSI08725. Oct. 2, 2008.

MRID 47582404, Gagne, James A. The potential for indirect effects on the California red

- legged frogfrom the use of 2,4

- D. Compliance Services International. Study No. CSI08726. Sept. 9, 2008.

Please note

— The Task Force also included the EDSP studies in its list. They are not shown here; they are in review, and a timeline has not been decide d for completion of reviews and decision

- making.8 Attachment 4

-- Questions for the 2,4

- D Task Force

Use Information

—

please provide:

A breakdown by crop

, state , and active ingredient of the usage (e.g. total pounds applied, total area treated, etc. ) for the last five years and typical application rates (rather than maximum rates allowed by the label) for the herbicidal uses of 2,4

- D. Please include information on the non

- agricultural uses of 2,4

- D, including golf courses, institutional turf, landsc ape, turf farms, nurser ies, greenhouse s , and use by lawn care professional s and by consumers. A separate breakdown for 2 ,4

- D/ fertilizer combination product s

. Parallel use information for the pre

- and post

- harvest uses on citrus. A breakdown by geographi c region and active ingredient for the aquatic uses of 2,4

- D: total amount used annually (5

- year average), weed spectrum, predominant types of waterways where the products are used, and predominant application methods.

Future Plans of the Task Force

Are there any 2,4

- D product registrations, particularly any owned by registrants that are not Task Force members, with use parameters that differ from those laid out in the Master Label? Are there any use sites listed on 2,4

- D product labels that the Task Force does not or will not support? Are there any 2,4

- D product registrations or uses that the Task Force expects will be terminated in the next few years? Are there any new uses the Task Force anticipates adding in the next few years?

Labeling and use parameters

The directions for use on the label for EPA Registration # 5481

- 145 include the following statement in reference to the treatment of lemons to retain buttons : “If a water

- wax emulsion is not used, then a separate treatment must be arranged to follow the final fresh water rinse of the fruit. Such a treatment could be designed so as to flush a growth regulator solution over the fruit and re

- circulate the ·surplus or apply a very fine spray of growth regulator to the fruit and not re

- circulate the small surplus. The amount of growth regulator adhering to the fruit would be about the same in either case, so no change in concentration would be necessary. A 500 ppm concentration of 2,4

- D is recommended. This is obtained by adding 1

- 5/8 fluid ounces 9 [of product] t o each 10 gallons of water. ”

In the May 2012, v15 master label

, on page 37, the rate for postharvest application to lemons reads “500 ppm” under the heading "MAXIMUM APPLICATION RATE/Acre

, " but from the description on the product label, it seems that 500 ppm is the concentration of 2,4

- D in the spray or dip solution rather than a rate on the treated produce. How should we calculate the application rate on a unit basis (e.g., per 100 lbs lemons)?9 Attachment 4

-- Questions for the 2,4

- D Task Force (continued)

Please refer to Attachment 5 for additional use information questions, concerning mainly retreatment intervals and the expression of application rates. Please respond within two weeks. Please respond to BEAD’s 7/16/12 comments on spreads heet within two weeks.

Data in development

Is the Task Force involved in the development of any new data it believes may be useful when the Agency begins the risk assessment phase of the 2,4

- D registration review process? (Dow) For the c holine salt, what b ridging approach have you used or do you intend to use for new data, including fate & effects data ?

Stewardship

EPA PR Notice 2001

- 5 provides guidance on labeling for pesticide resistance management. Will the Task Force make a commitment to amend 2,4

- D lab els consistent with the recommendations in the PR Notice? The link to the PR Notice is http://www.epa.gov/PR_Notices/pr2001

- 5.pdf

. Previous endangered species assessments and Biological Opinions for 2,4

- D have included some findings of “likely to affect,” “likely to adversely affect,” “likely to jeopardize the continuing existence,” and “likely to destroy or adversely modify designated habitat” in limited geographic areas for a number of listed sp ecies (California red

- legged frog, Alameda whipsnake, salmonids). The registration review of 2,4

- D will include assessments for listed species across the area in which 2,4

- D is used, and in light of previous evaluations, it seems reasonable to anticipate that these assessments will find that some uses of 2,4

- D are likely to adversely affect some listed species. What steps might the Task Force take to mitigate risks to listed species? Information suggests that 2,4

- D products are involved in a substantial p roportion of drift complaints/incidents. Does the Task Force intend to add specific requirements for controlling drift on product labels to supplement general statements on labels now? Does the Task Force envision addressing drift concerns through any ot her means? Is the Task Force involved in any research efforts with the objective of managing drift?10

Attachment 5

-- Missing Label Information for EFED Risk Assessment (7/16/12)

Use Missing Information Comments Cereal grains Minimum application interval Label specifies a post

emergence application and a
pre

- harvest application, but does not indicate the minimum number of days that should be between the two. These first four comments relate to length of growing season (BEAD input ? ) Field corn and pop corn Minimum application interval Label specifies a pre

emergence and post

emergence application, but does not indicate the minimum number of days that should be between the two. Sugarcane Minimum application interval Label specifies a pre

emergence and p ost

emergence application, but does not indicate the minimum number of days that should be between the two. Rice Minimum application interval Label specifies a pre

- plant and post

- emergence application, but does not indicate the minimum number of days that should be between the two.

The label does provide information stating that first application should occur at least 2 weeks before rice is planted and second application could occur as early as 6 weeks after the rice emerges. EFED could use make the assumption that an 8 week minimum is necessary between the first and second applications. Filberts Application rate is not in lb ae/A The application rate should be converted from the reported 1 lb ae/100 gal in to a rate that is11

Use Missing Information Comments

Maximum annual/seasonal application rate in lb ae/A.

The maximum annual/seasonal application rate is not specified, but EFED could make the assumption that it is equivalent to the maximum single application rate (1 lb ae/100 gal) times the maximum number of applications allowed in a season (4 times), which would equal 4 lb ae/100 gal. Ornamental turf Minimum application interval Label specifies 2 applications per year, but does not indicate the minimum number of days that should be between the applications. Tree and brush cont rol Application rate is not in lb ae/A The single maximum application rate for basal spray, cut surface

– stumps, and frill is reported as 8 lb ae/100 gal rather than in lb ae/A.

The single maximum application rate for injections is reported as 2 ml of 4 lb ae/injection site, rather than in lb ae/A. Comments relate to density of planting (can BEAD help?) Low bush blueberries Application rate is not in lb ae/A

Minimum application interval Application rate is reported in lb ae/10 gal rather than in lb ae/A

Label specifies one application per crop stage, but does not indicate the minimum number of days that should be between applications. It also does not specify the crop stages, so it would be difficu lt to estimate the number of days12

Use Missing Information Comments

Maximum annual/seasonal application rate between them if the stages themselves are not defined.

A maximum annual/seasonal rate is not specified on the label and because other label information is missing, EFED cannot make its own estimate. High bush blueberries Minimum application interval Label specifies a post

emergence and post

- harvest application, but does not specify the minimum number of days that should be between the two. Th is and comment below relate to length of growing season (BEAD input ? ) Cranberrie s Minimum application interval Label specifies one dormant application and two post

emergence applications, but does not indicate the minimum number of days that should be between each application. Citrus (navel and valencia oranges) Application rate not reported in lb ae/A Application rate is reported as 200 ppm and not in lb ae/A. Furthermore, it is unclear if the ppm applies to a tree, per orange, etc.; thus it is impossible for EFED to make assumptions that would allow us to estimate a lb ae/A rate. Citrus (lemon, navel and valencia oranges, tangelos) Application rate not reported in lb ae/A Application rate is reported as 24 ppm. Furthermore, it is unclear if the ppm applies to a tree, per fruit, etc.; thus it is impossible for EFED to make assumpt ions that would allow us to estimate a lb ae/A rate.131415