Page 2 of 6 A. PHYSICIANS COMMITTEE FOR RESPONSIBLE MEDICINE (PCRM)

COMMENTS :

1. PCRM Comment:

“The Summary Document indicates that the Agency may request testing for avian acute oral toxicity. We strongly support the use of the newly revised OECD Test Guideline 223 for the acute avian oral toxicity test...”

EFED Response :

To date the OECD has adopted the TG 223 guideline and has issued a validation report. At this time EFED is actively evaluating the results of the OECD validation report to determine if the TG 223 effects endpoints and dose/response information adequately address the purposes of the

a vian acute oral data requirement as described in 40 CFR Part 158. Until the Agency’s evaluation of that validation report is completed, EFED will not classify avian toxicity studies performed using the TG 223 protocol and the studies cannot be used to ful fill current data requirements.

2

. PCRM Comment:

“In response to past comments on the avian acute oral toxicity test... ‘EPA is not likely to accept studies conducted under the OECD guideline unless additional study validation is conducted for passerine species (from EFED Response to Comments on Preliminary Work Plan for Sodium Acifluorfen )’... If the Agency is interested in collecting all data in consideration of the use of the 223 then it should not state that it will not accept information gathered acco rding to this protocol.”

EFED Response :

EFED will consider all data submitted regarding the potential toxicity of pesticides. In reading through the previous Agency response, we understand how the sentence ‘EPA is not likely to accept studies conducted under the OECD guideline...” could be misunderstood. To clarify what was meant, the Agency will not be able to classify studies conducted using TG223 and passerines as ‘acceptable’ (and, thus, fulfilling guideline requirements) until it is verified that th e OECD TG 223 using passerines adequately addresses the purposes of the passerine acute oral data requirement as described in 40 CFR Part 158.

B

. AMERICAN BIRD CONSERVANCY (ABC) COMMENTS :

1. ABC Comment:

“The incident involving 18 pigeons was a delibe rate poisoning incident, and strengthens the argument that methomyl should be labeled as Restricted Use, to prevent further abuse.”Page 3 of 6 EFED Response :

EFED defers a specific response to this comment to OPP’s Pesticide Re

- evaluation Division (PRD) since it relates directly to risk management, labeling, and product registrations

.

2

. ABC Comment:

“Additionally, though relatively few incidents involving methomyl have formally been reported to ABC or EPA, the absence of incident reports cannot be construed as the absence of incidents.”

EFED Response :

EFED agrees that an absence of ecological incident reports cannot be used as evidence that incidents do not occur. Therefore, the incident data will be used accordingly in the ecological

risk asses sment conducted for methomyl.

3

. ABC Comment:

“ABC request that EPA considers mitigation of the application of methomyl, such as plowing in the granules post application.”

EFED Response :

EFED defers a specific response to this comment to PRD since it relates directly to risk management, labeling, and product registrations

.

4

. ABC Comment:

“Additionally, the Agency should evaluate whether the risk from puddles of standing water within 24 hours of irrigation. If the puddle model indicates a risk t o birds, this method of application should be withdrawn, or specific monitoring requirements should be implemented...”

EFED Response :

EFED is actively working on tools that will address assessing risks to non

- target animals (including birds) from exposur e through drinking water, including puddles. If these tools are available, th is potential exposure pathway will be considered quantitatively in the methomyl ecological risk assessment conducted for Registration Review. Regarding withdrawing the registration of methomyl products or requiring monitoring data, EFED defers a specific response

to these comment s to PRD since they relate directly to risk management

.

5

. ABC Comment:

“ 1) ABC requests an avian oral toxicity test using a passerine species.

2) ABC requests an avian reproduction study with a mallard duck...”Page 4 of 6 EFED Response :

EFED recommended that the Agency request both an acute oral passerine and an avian reproduction study with the mallard duck in the methomyl Problem Formulation.

6

. ABC Comment:

“... ABC requests an avian reproductive and developmental study using a passer ine species. ABC recognizes that EPA does not have an official Standard Operation Procedure (SOP) to recommend to registrants for passerine reproductive studies, however, we urge EPA to look beyond the lack of SOP and investigate the potential toxicity of this compound.”

EFED Response :

EFED is not aware of any data to show that methomyl is more toxic to passerine species than it is to bobwhite quail ( Colinus virginianus ) or mallard ducks ( Anas platyrhynchos ) on a chronic exposure basis as it relates to reproductive endpoints. Therefore, at this time, EFED believes that the data from the reproductive studies in the bobwhite quail and mallard duck studies will be adequate fo r assessing potential risks of methomyl to birds from chronic exposure.

7

. ABC Comment:

ABC requests a “...(m)itigation effort such as requiring users to plow in Methomyl 5G Granule.”

EFED Response :

EFED defers a specific response to this comment to PRD since it relates directly to risk

management

.

8

. ABC Comment:

ABC requests the “... (r)elease of formulation information of the Methomyl 5G Granule. The granule content information of Methomyl 5G Granule is Confidential Business Information (CBI). It is impossible to fully assess the risks of a granular formulation if we do not know if the granule is made from clay or silica...”

EFED Response :

EFED does have access to this type of information and it is considered in our ecological risk

assessments

. However, because specific formulation information is CBI, it must be pr otected as

described in FIFRA.

9

. ABC Comment:

ABC requests that interim label changes be made to mitigate risks to birds from the use of methomyl since the registration review process is “so prolonged”.Page 5 of 6 EFED Response :

EFED defers a specific respons e to this comment to PRD since it relates directly to risk

management

.

C

. DUPONT CROP PROTECTION (DCP) COMMENTS :

1. DCP Comment:

“GDLN 835.2240

– Aqueous Photolysis

GDLN 835.4100

– Aerobic Soil Metabolism

GDLN 835.4300

– Aerobic Aquatic Metabolism

GDLN 835.4400

– Anaerobic Aquatic Metabolism

Dupont believes existing data meets these data needs. Discussion with the Agency will determine if these data will fulfill the data requirements.”

EFED Response :

EFED’s problem formulation for methomyl, which may be found in the docket at www.regulations.gov ( EPA

- HQ

- OPP

- 2010

- 0751 ), provides details on the environmental fate data deficiencies and information needed to conduct an exposure assessment for Registration

Review. We look forward to receiving data that address these needs.

2

. DCP Comment:

“GDLN 850.2300

– Avian reproduction study (mallard duck)

DuPont has conducted an avian reproduction study with the mallard (MRID 41898601) that satisfies this data requirement. This study was categorized as core and determined to fulfill the guideline requirement in the methomyl RED document.”

EFED Response :

The study cited (MRID 41898601) cannot be used to fulfill guideline requirements because there were effects noted at all treatment concentrations (the NOAEC from the mallard reproduction study is <50 mg a.i./kg

- diet based on decreases in adult male body we ight). This indicates that the mallard duck may be more sensitive to methomyl than the bobwhite quail on a chronic exposure basis. Therefore, EFED recommends requesting a reproduction study (850.2300) with the mallard duck to fulfill this data gap.

3

. DCP Comment:

“On July 15, 2010, DuPont submitted comments on the NMFS Biological Opinion and EPA’s proposed measures. A response from the Agency is pending.”Page 6 of 6 EFED Response :

The Agency has reviewed the comments DuPont submitted relative to the Endangere d Species

Protection Bulletins resulting from ESA consultation with the National Marine Fisheries Service

. A letter is currently being prepared to explain how the Agency disposed of all comments it

received on those bulletins

.

4. DCP Comment:

“DuPont i ntends to provide information on multiple crop cycles to the Agency for use in risk assessments conducted for Registration Review.”

EFED Response :

EFED appreciates that DuPont will provide the Agency information on multiple crop cycles and

looks forward to receiving the data and reviewing them for adequacy and suitability for use in

risk assessment.

5. DCP Comment:

Regarding Table 3.2 in the Problem Formulation, “(t)he Lannate® SP formulation should have Chemigation listed under Methods of Application. ”

EFED Response :

EFED appreciates the information provided by DuPont. EFED will review the Lannate® LV label and will make changes to the method of application as appropriate when conducting the ecological risk assessment for methomyl during the Registration Review process.

6. DCP Comment:

Regarding the environmental fate data requirements, “DuPont believes existing data meets these data needs. Discussion with the Agency will determine if these data will fulfill the data requiremen ts.”

EFED Response :

See response #1.