Notes from 2,4-D Registration Review Focus Meeting 7/17/12; 1-3 pm, PY South, S9100

Agenda and attendance sign-in sheets 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.

Purpose 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 help 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 from the 

schedule were included in the meeting agenda 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 assumptions 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 in 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 indicated 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 Task 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 fill 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 for 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.

Attachments 
Agenda 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 pm

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 Document
Attachment 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 

Environmental 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 Dumas
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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 Miller; Data Group Management, TF Account
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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 requirements
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Attachment 3—Task Force’s list of submissions not reviewed (as of March 2012)

MRID 46487501, Risk 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, 2011.

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 Services 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 decided for completion of reviews and 

decision-making.
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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, landscape, turf farms, nurseries, greenhouses, and use by lawn care professionals

and by consumers. 

A separate breakdown for 2,4-D/fertilizer combination products. 

Parallel use information for the pre- and post-harvest uses on citrus.

A breakdown by geographic 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] to 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)?
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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 spreadsheet 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 choline salt, what bridging 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 labels 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 species (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 proportion 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 other means? Is the Task 

Force involved in any research efforts with the objective of managing drift?
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Attachment 5-- Missing Label Information for EFED Risk Assessment (7/16/12)

Use Missing Information Comments

Cereal grains Minimum application interval Label specifies a postemergence 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 preemergence and postemergence application, but 

does not indicate the minimum 

number of days that should be 

between the two.

Sugarcane Minimum application interval Label specifies a preemergence and postemergence 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 into a rate that is 
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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 control 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 difficult 

to estimate the number of days 
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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 postemergence and post-harvest 

application, but does not 

specify the minimum number 

of days that should be between 

the two. This and comment 

below relate to length of 

growing season (BEAD 

input?)

Cranberries Minimum application interval Label specifies one dormant 

application and two postemergence 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 

assumptions that would allow 

us to estimate a lb ae/A rate.
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